Policy News for the Nanotechnology Value Chain
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  • In 2012, the Council of Europe (CoE) Parliamentary Assembly began the first steps towards nanotechnology regulation with a view to respecting the scientific precautionary principles. It commissioned an expert report, "Nanotechnology: balancing benefits and risks to public health and the environment", enthusiastically accepted at the CoE meeting of the Committee on Social Affairs, Health and Sustainable Development in November 2012. That same report is slated for public debate before the entire Council of Europe Parliamentary Assembly in Strasbourg France, April 26, 2013. Read more >>

  • Sometimes, all it takes is an extremely small amount of material to make a big difference. Scientists at Argonne National Laboratory have recently discovered that they could substitute one-atom-thick graphene layers for oil-based lubricants on sliding steel surfaces, enabling a dramatic reduction in the amount of wear and friction.  Read more >>

  • Yesterday morning, the National Academy of Sciences had the honor of President Barack Obama delivering an historic speech in celebration of NAS's 150th anniversary. President Obama reflected on Abraham Lincoln's fortitude in founding the National Academy of Sciences 150 years ago, and also explained the importance of setting priorities for research, continuing our nation's scientific advance, and maintaining our cutting edge with a fidelity to facts, truth, and following the evidence. The President emphasized that investments made today in science, technology, engineering, and medicine are all critical to the nation's prosperity, and are bound to pay off for many years to come.  Read More>>

  • Cancer cells appear to move more slowly after they have “vacuumed” up nanoparticles, according to new experiments by researchers at the University of Illinois at Urbana−Champaign. The finding might be important for developing future nanoparticle-based therapeutics, they say.   Read more

  • In this work the effects of four different multiwalled carbon nanotubes (MWCNTsRead more

  • Among other things, the wide-scale development and use of nanomaterials is expected to produce costly regulatory and civil liabilities for nanomanufacturers due to lingering uncertainties, unanticipated effects, and potential toxicity. Read more

  • The addition of carbon nanotubes (CNTs) remarkably improves the mechanical characteristics of base materials. Read more

  • Urban health is potentially affected by particle emissions. The potential toxicity of nanoparticles is heavily debated and there is an enormous global increase in research activity in this field. Read more

  • The College of Law has published a special nanotechnology conference issue of Jurimetrics: The Journal of Law, Science and Technology that focuses on innovate new oversight models for rapidly emerging nanotechnologies. Read more

  • The OECD Guidelines for the Testing of Chemicals are internationally accepted standards and used for risk assessments, but their applicability to nanomaterials is not tested. Read more

  • Article 16 of the Cosmetic Regulation EC No 1223/2009 requires any cosmetic product containing nanomaterials to be notified to the Commission six months prior to being placed on the market. Read more

  • The nanotoxicology community should implement guidelines on the types of information that are required in their research articles to improve the quality and relevance of the published papers. Read more

  • Norwegian researchers are among the first in the world to use radioactivity to trace nanoparticles in experimental animals and soil. Read more

  • The topic concerning the regulation of nanotechnology is an ongoing controversial discussion in many countries and in international forum around the world. Read more

  • A strip of glass covered in hairy nanoparticles can cheaply and conveniently measure mercury, which attacks the nervous system, and other toxic metals in fluids. Read more

  • The UK Nanosafety Partnership Group (UKNSPG) has developed and published guidance to support safe and responsible working practices with nanomaterials in research and development laboratories. Read more

  • The NIST has introduced a new nanoscale reference material that is actually a commercial titanium oxide popularly known as “P25.” Read more

  • A decade ago, nanoscience shifted into overdrive. Government funding levels were beginning to rise, and the U.S. was setting up its National Nanotechnology Initiative (NNI). Nanomaterials were gaining ground, and venture capitalists were backing dozens of start-up manufacturing companies. Read more

  • The topic concerning the regulation of nanotechnology is an ongoing controversial discussion in many countries and in international forum around the world. In some countries, nanomaterial labeling is not required while in others it is .Read more

  • Scientists worry that not enough testing has been done yet to understand the effects on the environment -- how will tiny particles affect plants and animals that we eat, for example? Read more

  • Risk & Policy Analysts Ltd with IVAM UvA BV, have been commissioned by the European Commission to assess the potential socio economic, health and, if relevant, environmental impacts for the EU and EEA arising from the use of engineered nanomaterials and nanotechnology in the workplace. Read more

  • The OECD Guidelines for the Testing of Chemicals are internationally accepted standards and used for risk assessments, but their applicability to nanomaterials is not tested. Read more

  • Friends of the Earth have lodged an ASX complaint against sunscreen ingredient manufacturer Antaria. The group claim that by failing to notify the ASX of evidence that its ZinClear IM product is a nanomaterial, and that the product’s ECOCERT accreditation has been suspended, the company is in violation of the Corporations Act (2001). Read more

  • More coherence and structure in the way research is conducted should be introduced in nanotoxicology, and all stakeholders must do their part. Read more

  • A multi-institute team headed by researchers at University of California, Santa Barbara's Bren School of Environmental Science & Management has studied the environmental impact of nanomaterials by growing soybeans in soil polluted by two manufactured nanomaterials (MNMs). Read more

  • A new type of paint made with carbon nanotubes at Rice University can help detect strain in buildings, bridges and airplanes. Read more

  • There are serious gaps in our awareness of the potential risks involved in handling nanomaterials at work, and serious shortcomings in the way that those risks are communicated to workplaces, according to a new literature review from the European Agency for Safety and Health at Work (EU-OSHA). Read more

  • RTI International recently launched the Nanomaterial Registry, an authoritative, web-based resource that organizes and evaluates the biological and environmental implications of well-characterized nanomaterials from publically available resources. Read more

  • It’s become a rallying cry for some researchers who are scrutinizing the potential health and environmental effects of super-small particles: Test the products that use nanomaterials, not just the substances themselves. Read more

  • The growing number of industrial applications for nanotechnologies is increasing workers' risk of exposure to substances whose health effects are still not well known. Read more

  • The United States Environmental Protection Agency (EPA) last week filed a brief calling on the court to dismiss a case against its approval of a nanoscale material. Read more

  • Researchers at University of Edinburgh have quantified the health impact of nanofibers, paving the way to reduce health risks faced by people working with these small fibers utilized in manufacturing industries. Read more

  • According to a collaborative study conducted by the United States Geological Survey and the University of Missouri, carbon nanotubes can be harmful to aquatic organisms. Read more

  • New research from the National Institute for Occupational Safety and Health (NIOSH) raises awareness of the occupational safety and health practices necessary during the synthesis, characterization and experimentation using engineered nanomaterials in a laboratory setting. Read more

  • The U.S. Food and Drug Administration will soon have a new nanotechnology safety program, thanks to language tucked into a massive legislative package that’s on its way to President Obama. Read more

  • Textile manufacturers add titanium dioxide to some clothing to brighten it and to prevent the color-fading effects of ultraviolet light.  Read more

  • Once again, here come the headlines, across both the trade and mainstream press, warning us that manufactured nanoparticles are a danger to our health and environment.   Read more

  • Nanotechnology is often referred to as being a “key technology” of the 21st century, and the expectations for innovative products and new market potentials are high.   Read more

  • Nanomaterials are being developed for an array of applications including energy, manufacturing, waste treatment, consumer products, and medicine.  Read more

  • Improved sunscreens are just one of the many innovative uses of nanotechnology, which involves drastically shrinking and fundamentally changing the structure of chemical compounds. But products made with nanomaterials also raise largely unanswered safety questions — such as whether the particles that make them effective can be absorbed into the bloodstream and are toxic to living cells. Read more

  • Once again, here come the headlines, across both the trade and mainstream press, warning us that manufactured nanoparticles are a danger to our health and environment. Read more

  • The discovery of graphene has brought much excitement to the nanotechnology community. Much of this excitement is due to the possibility of deriving graphene-based materials with applications in electronics, energy storage, sensing and biomedical devices.  Read more

  • Health risks posed to people who work with tiny fibres used in manufacturing industries could be reduced, thanks to new research.  Read more

  • Many chemists think encapsulating cancer drugs inside nanoparticles could lead to more efficient and specific drug delivery. Read more

  • Infant lungs are particularly prone to nanoparticle deposition, be it from pollution or inhaled medicines, as air flows differently inside them, say US researchers. Read more

  • Dr. Chris Metcalfe, professor and director of the Institute for Watershed Science at Trent University, is the principal investigator on the Lake Ecosystem Nanosilver (LENS) project with Trent researchers, Drs. Maggie Xenopoulos, Holger Hintelmann and Paul Frost, and colleagues from Fisheries and Oceans Canada and Environment Canada. Read more

  • Last week, President Obama visited Albany, New York to tout the role that academic institutions like the University of Albany’s NanoCollege play in driving “the future of our economy.” Read more

  • A lawsuit against the U.S. Food and Drug Administration over nanotechnology has been dismissed as moot. Last year, several nonprofit groups filed a lawsuit alleging the agency unlawfully ignored their petition to regulate nanomaterials. Read more

  • A substance might potentially be harmful or even toxic for a biological system, provided that the quantity or the concentration (the "dose") is high enough. The toxic effect (toxicity) increases in case of an increased exposition (or dose). This phenomenon has been known since Paracelsus (1493-1541), the father of toxicology defined: "All substances are poisons, and there is none which is not a poison; only the dose permits something not to be poisonous." Even water might be toxic, provided in sufficiently large quantities within a short time. The effect depends on whether a single dose is strong enough (acute dose) or whether low doses are administered over an extended period of time (chronic dose). Read more

  • Polluted-air contains thousands of health-damaging nanometer size (~100-1000 times smaller than the width of a human hair) tiny particles. These tiny pollutants penetrate deep into the lungs and are an important factor in the development of various diseases. Read more

  • The International Organization for Standardization (ISO) recently published a Technical Report (TR) that provides guidance on the physicochemical characterization of manufactured nano-objects prior to toxicological assessment. ISO TR 13014:2012, Nanotechnologies - Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment, is intended to assist health scientists and experts to understand, plan, identify, and address relevant physicochemical characteristics of nano-objects before conducting toxicological tests on them. Read more

  • The United States Environmental Protection Agency (EPA) proposed, in December of last year, significant new use rules (SNURs) for 17 chemicals, including carbon nanotubes and fullerenes. Now several unions and environmental health groups are urging the EPA to strengthen worker protections in the proposed new rules. Read more

  • GAINESVILLE, Fla. — The percentage of electronic waste occupying our landfills has grown at an alarming rate over the last decade, giving rise to concerns about the toxicity of components used in consumer electronics.

    Researchers at the University of Florida are looking for ways to minimize environmental hazards associated with a material likely to play an increasingly important role in the manufacture of these goods in the future. The results of their most recent studies are published in the March 2012 issue of Nanotoxicology. Read more

  • What are the implications of nanotechnology for the general public? What use is it to them? What are the risks and benefits? These are the types of questions that an online Knowledge Debate hopes to provoke. Read more

  • The European Commission has released the the third edition of the Nanosafety Cluster compendium (pdf). It documents the status of important projects on nanomaterial toxicity and exposure monitoring, integrated risk management, research infrastructure and coordination and support activities. Read more

  • “The risks and benefits of this emerging technology are still being discovered, yet the development, use and manufacturing of nanomaterials are being conducted with little transparency and inadequate regulatory oversight. This is particularly concerning to the food industry where human exposure is virtually guaranteed. Read more

  • A research team comprising Jean-Claude Bonzongo and Kirk Ziegler from the University of Florida is working on ways to reduce environmental hazards of carbon nanotubes. Read more

  • At the American Chemical Society’s 243rd National Meeting & Exposition, a research team led by Paresh C. Ray from the Jackson State University in Mississippi has delivered a presentation on a gold nanoparticle-based method to rapidly detect the presence of Salmonella bacteria, particularly the multiple-drug resistant (MDR) strains in lettuce. Read more

  • A research team from the University of Limerick (UL) led by Dr. Syed Tofail from UL’s Materials and Surface Science Institute (MSSI) has joined SANOWORK, a project funded by European Commission (EC), to evaluate and control potential risks related to nanomaterials. Read more

  • The French Ministry for Ecology, Sustainable Development, Transportation and Housing has recently published a final decree regarding the mandatory reporting of nanomaterials. The decree, which was signed in February 2012 and will be applicable from January 2013, requires companies that manufacture, import, distribute nanomaterials in quantities  of ≥ 100g to submit to the authorities an annual declaration containing the quantity and use information. Read more

  • The Food and Drug Administration issued two draft guidances April 20 on the assessment of the effects of nanotechnology on food and cosmetics safety. Read more

  • As nanoparticles increasingly make their way into consumer products and the environment, toxicologists want to understand their effects on human health. Ideally, they’d like to develop models that predict a material’s toxicity based on its chemical properties. Now a research team reports the first such model for metal oxide nanoparticles that uses the materials’ electrical and solubility properties Read more

  • Many chemists think encapsulating cancer drugs inside nanoparticles could lead to more efficient and specific drug delivery. But these nanoparticles often struggle to penetrate inside a tumor or to release their drug payloads once they’re in place. Now researchers demonstrate a solution to both problems using polymer nanoparticles that expand and contract when excited by certain wavelengths of light . Read more

  • Infant lungs are particularly prone to nanoparticle deposition, be it from pollution or inhaled medicines, as air flows differently inside them, say US researchers. Read more

  • Presently, many consumer products contain nano-sized materials (NMs) to improve material properties, product quality and ease of use. NMs in food additives and in cosmetic articles (e.g., tooth paste) may be taken up by the oral route. As adverse effects of environmental nanoparticles, like ultrafine particles, have been reported, consumers worry about potential risks when using products containing NMs. Read more

  • The use of nanoparticles (NPs) in industry is increasing rapidly, but knowledge of the occupational health and safety aspects of NPs is still limited. This is because quantitative NP exposure levels are scarce, and the metrics to describe doses are unclear.Read more

  • Nanotechnology is considered as one of the key technologies of the 21st century and promises revolution in our world. Objects at nano scale, take on novel properties and functions that differ markedly from those seen in the corresponding bulk counterpart primarily because of their small size and large surface area Read more

  • It is expected that the rapid expansion of nanotechnology will bring many potential benefits. However, initial investigations have demonstrated that nanomaterials may adversely affect human health and the environment. Read more


     
  • Due to the large number of possible applications of nanoparticles in cosmetic and medical products, the possible hazards of nanoparticles in the human body are a major concern. Read more

  • Researchers from BioSeek and the U.S. Environmental Protection Agency (EPA) have presented the evaluations of the biological activity of different chemicals and nanomaterials in the background of primary human cell biology at the Society of Toxicology’s annual meeting. Read more

  • Researchers from BioSeek and the U.S. Environmental Protection Agency (EPA) have presented the evaluations of the biological activity of different chemicals and nanomaterials in the background of primary human cell biology at the Society of Toxicology’s annual meeting. Read more

  • The Norwegian Institute of Public Health recently conducted a study to determine the effect of silver and titanium dioxide nanoparticles on testicular cells. They found that titanium dioxide nanoparticles caused comparatively lesser damage than silver nanoparticles. Read more

  • Today, the French government published its response to the public nano-debate organised from 15 October 2009 until 24 February 2010. The response was sent to the President of the Committee for National Public Debate CNDP on 13 February. Read more

  • Silver nanoparticles cause more damage to testicular cells than titanium dioxide nanoparticles, according to a recent study by the Norwegian Institute of Public Health. However, the use of both types can affect sperm production with consequences for fertility of future generations. Read more

  • Safe Work Australia Chair, Mr Tom Phillips AM, today announced the release of a new publication on the Safe Handling and Use of Carbon Nanotubes (doc). Read more

  • Researchers at Oregon State University have tapped into the extraordinary power of carbon “nanotubes” to increase the speed of biological sensors, a technology that might one day allow a doctor to routinely perform lab tests in minutes, speeding diagnosis and treatment while reducing costs. Read more

  • MEXICO CITY, Mar 12 (Tierramérica).- Nanotechnology, which is currently unregulated in Mexico, could pose serious threats to human health and the environment, cautions a new study. Read more

  • Research and Markets has added a new book in its nanotechnology series, named, ‘Nanotechnology and Energy: Science, Promises and its Limits’. Read more

  • Nanotechnology has several prospective applications in drinks and food packaging, especially in fruit, vegetables, poultry, meat and beverages. The novel technology delivers additional barrier properties to prevent spoilage for a longer period. New advancements are also optimizing the capability of the innovative technology to develop packaging capable of detecting when food has been contaminated or spoiled. Read more

  • Nanoseeds Technology and 141 Capital have inked a licensing deal to produce and sell the Nanoseeds protective crop coating technology in the North American region. Read more

  • According to a research study reported in Industrial & Engineering Chemistry Research, a journal of the American Chemical Society, dust formed during manufacturing of nanomaterials has more chance to get exploded when compared to dust from cornstarch, wheat flour and any other usual dust explosion hazards. Read more

  • As You Sow's first-of-its-kind framework is designed to help food companies make informed decisions regarding sourcing products containing nanomaterials. Read more

  • REACH, the European Union's primary regulation on chemicals is failing to identify or control nanomaterials. That is the conclusion of "Just Out of REACH: How REACH is failing to regulate nanomaterials and how it can be fixed," a new report by the nonprofit Center for International Environmental Law (CIEL). Nanomaterials, tiny manmade particles with extraordinary properties, are a fast-growing component of cosmetics, clothing, consumer electronics, and other products. Read more

  • Microscopic bits of metal – nanoparticles, a thousand times smaller than the thickness of a human hair – have been touted as a biotechnology and manufacturing miracle. Among many other applications, they can be used to keep the smell out of sweaty gym clothes, to treat wastewater, and they are being considered as a way to deliver cell-specific cancer drugs. However, as a recent experiment shows, the very properties that make nanoparticles so valuable in killing harmful and unpleasant bacteria also kill ocean phytoplankton that regulate the climate and are the base of the oceans’ food chain. Read more

  • In the absence of labelling for products containing nanoparticles, a guide printed by a lobby group has been the only way for consumers to find out which sunscreens are 'nano-free'. Read more

  • The National Research Council (NRC) of the National Academies has been working for several years on the development of a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. On January 25th they released a draft of this strategy, which is available from the National Academies website. This work was commissioned by the Environmental Protection Agency. Read more

  • With expanded industrial-scale production of nanomaterials fast approaching, scientists are reporting indications that dust generated during processing of nanomaterials may explode more easily than dust from wheat flour, cornstarch and most other common dust explosion hazards. Their article in ACS’ journal Industrial & Engineering Chemistry Research indicates that nanomaterial dust could explode due to a spark with only 1/30th the energy needed to ignite sugar dust — the cause of the 2008 Portwentworth, Georgia, explosion that killed 13 people, injured 42 people and destroyed a factory. Read more

  • Billions of engineered nanoparticles in foods and pharmaceuticals are ingested by humans daily, and new Cornell research warns they may be more harmful to health than previously thought. Read more

  • Children may be receiving the highest exposure to nanoparticles of titanium dioxide in candy, which they eat in amounts much larger than adults, according to a new study. Published in ACS’ journal, Environmental Science & Technology, it provides the first broadly based information on amounts of the nanomaterial – a source of concern with regard to its potential health and environmental effects – in a wide range of consumer goods. Read more

  • Tests involving chickens have raised questions about the impact on health from engineered nano-particles, the ultra-fine grains commonly used in drugs and processed foods, scientists said. Chickens exposed to high oral doses of polystyrene particles 50 nanometres (50 billionths of a metre) across absorbed less iron in their diet, according to their study. Read more

  • Despite extensive investment in nanotechnology and increasing commercialization over the last decade, insufficient understanding remains about the environmental, health, and safety aspects of nanomaterials.  Without a coordinated research plan to help guide efforts to manage and avoid potential risks, the future of safe and sustainable nanotechnology is uncertain, says a new report from the National Research Council. Read more

  • This article, “Paradigms to Assess the Environmental Impact of Manufactured Nanomaterials,” in the journal Environmental Toxicology & Chemistry, seeks to answer several questions: “Where does the science need to provide reliable data that will assist policymakers and regulators develop strategies to manage nanomaterials and instill public confidence regarding the safety of these materials? What are the critical needs that will move us forward safely and intelligently in this promising field? Are the paradigms generally developed to assess the fate and effects of solute contaminants applicable to nanomaterials?” The authors propose a way to answer the posed questions, thus moving nanotechnology environmental, health and safety forward. Read more

  • The International Center for Technology Assessment (ICTA) welcomes the findings of a new report by an expert panel yesterday, which concluded that despite the surge of nanomaterials in the marketplace, not enough is known about their potential health and environmental risks. The panel was convened by the National Research Council (NRC), the research arm of the National Academy of Sciences, at the request of the Environmental Protection Agency (EPA). Read more

  • Not enough is known about the potential hazards of nanotechnology, and millions of dollars more a year are needed to study the potential health and environmental effects of it, said the National Research Council yesterday. Read more

  • Nanoparticles are really tiny manufactured objects, no bigger than a clump of atoms.  They are being engineered into materials with unique electrical, chemical and optical properties. They are used in a wide array of products from cosmetics and food additives to solar cells and medical devices. Read more

  • Nanomaterials represent the building blocks of nanotechnology-enabled products and applications encompassing a broad range of substances and structures having features in the 1-100 nanometer range. Nanomaterials are of significant interest as they exhibit enhanced physical, chemical and electronic properties in comparison to their bulk counterparts. Read more

  • Be afraid, very afraid, when litigation lawyers start to wrap their brains around nanotechnology liability issues. Read more

  • The workshop intended to provide an overview and a forum for discussion to regulators, scientists and other stakeholders on recent regulatory and scientific developments in the field of Environmental Health and Safety Assessment of Nanomaterials, in particular from the ENPRA FP7 project. It included sessions on regulatory development and implementation, nanomaterials characterization, exposure, and effects. Read more

  • A recently released National Research Council (NRC) report, A Research Strategy for Environmental, Health, and Safety (EHS) Aspects of Engineered Nanomaterials (ENMs), largely reflects the strategic framework and principles outlined in the 2011 National Nanotechnology Initiative (NNI) Environmental, Health, and Safety (EHS) Research Strategy, released in October 2011. The following comparisons highlight some of the many ways in which these two strategies are concordant. Read more

  • Back in the early 2000's, food nanotechnology seemed to be a very hot topic and large industrial food companies were eager to explore new opportunities offered by nanotechnology applications. Then, as critical voices from NGOs (see for instance FoE's report: "Out of the laboratory and on to our plates: Nanotechnology in food and agriculture") and regulators (UK House of Lords report: "Nanotechnologies and Food") appeared, the food industry went into silent mode (see our Nanowerk Spotlight: "Food nanotechnology – how the industry is blowing it"). But that doesn't mean that food nanotechnologies aren't being researched and developed in labs around the world. Read more

  • As the applications of nanotechnologies continue to rapidly expand into a wide variety of industries, it is critical to consider any potential effects on human and environmental health. The NanoRelease project was initiated to assure that we have methods for the starting component of any evaluation of risk – which is measuring the amount that is actually released when a product is used. Read more

  • The National Research Council (NRC) released a long report last week identifying major gaps in environmental, health and safety research of nanomaterials. Its conclusion: “Despite the promise of nanotechnology…the future of safe and sustainable nanotechnology-based materials, products, and processes is uncertain.” Read more

  • While biotechnology has met with mixed public reactions, to date nanotechnology seems to invoke much less public concern. Read more

  • As You Sow's first-of-its-kind framework is designed to help food companies make informed decisions regarding sourcing products containing nanomaterials. Read more

  • Geneva— REACH, the European Union's primary regulation on chemicals is failing to identify or control nanomaterials. That is the conclusion of "Just Out of REACH: How REACH is failing to regulate nanomaterials and how it can be fixed," a new report by the nonprofit Center for International Environmental Law (CIEL). Nanomaterials, tiny manmade particles with extraordinary properties, are a fast-growing component of cosmetics, clothing, consumer electronics, and other products. Read more

  • SUN lovers may be raising their risk of skin cancer by avoiding sunscreen due to unfounded fears over nanoparticles, according to a federal government study released in Perth today. Read more

  • The Australian government’s National Measurement Institute has released early research at the International Conference on Nanotechnology (ICONN) in Perth this week that casts doubt on the nano content of popular sunscreens. This research highlights the failure of state and federal governments to regulate nano-sunscreens. Read more

  • Nanoparticles used in food and pharmaceuticals could have unintended physiological effects. This is the suggestion of US researchers who have showed that polystyrene nanoparticles can affect the uptake of iron - an essential nutrient - in a model intestine. Read more

  • The National Science Foundation (NSF) has granted the Faculty Early Career Development (CAREER) Awards to five Assistant Professors of the University of Houston, of which two are involved in the nanomaterial research. Read more

  • Prof. Dr. Sherif A. El-Safty, a Principal Researcher of the Materials Recycling Design Group, Research Center for Strategic Materials, National Institute for Materials Science developed a nanomaterial which enables simple detection and removal of arsenic from drinking water. Read more

  • According to the report published by BCC Research, the market value of the worldwide nanomedicine industry was $63.8 billion and $72.8 billion in 2010 and 2011, respectively. The market is estimated to grow at a CAGR of 12.5% to reach $130.9 billion by the fiscal year 2016. Read more

  • In a recent speech I made to business leaders in Boston, I explained that perched atop 26 years of experiences I've stacked up in nanobusiness, I have a pretty good view to the horizon. You know what I see?  Decades of investment by government and the private sector have grown into a field of economic opportunity, now ripe with good jobs. Read more

  • Radiological Technologies University VT, located in South Bend, Indiana is pleased to announce the approval of the first Master’s of Science in Nanomedicine degree program in the country. The formal approval was granted today through the Indiana Commission for Postsecondary Proprietary Education. Nanomedicine is the medical application of Nanotechnology which focuses its work at the cellular level to do everything from repairing tissue, to cleaning arteries, to attacking cancer cells and viruses like AIDS. Read more

  • The potential of advanced nanotechnology is getting some attention from mainstream media. Late last year The Guardian web site posted a brief article on the prospects for nanofactories and atomically precise manufacturing, featuring quotes from Christine Peterson and Robert Freitas. Read more

  • Foresight’s principal focus has been the development of advanced nanotechnology for atomically precise manufacturing, but the incremental development and application of current nanotechnology is also a major interest. Meeting the challenges of incremental nanotechnology development and application includes adequately addressing any potential environmental, health, and safety issues (see Foresight’s Nanoparticle safetypolicy brief.). Read more

  • The performance of an electrochemical multiwalled carbon nanotube (EC-MWNT) filter toward virus removal and inactivation in the presence of natural organic matter was systematically evaluated over a wide range of solution chemistries. Read more

  • The Bren School-based authors of a study published Jan. 20 in the journal PLoS ONE have observed toxicity to marine organisms resulting from exposure to a nanoparticle that had not previously been shown to be toxic under similar conditions. Read more

  • WASHINGTON — Despite extensive investment in nanotechnology and increasing commercialization over the last decade, insufficient understanding remains about the environmental, health, and safety aspects of nanomaterials. Without a coordinated research plan to help guide efforts to manage and avoid potential risks, the future of safe and sustainable nanotechnology is uncertain, says a new report from the National Research Council. The report presents a strategic approach for developing research and a scientific infrastructure needed to address potential health and environmental risks of nanomaterials. Its effective implementation would require sufficient management and budgetary authority to direct research across federal agencies.Read more

  • With these advances, researchers have heralded both positive and negative effects of nanotechnology. Advocates point to efficient energy consumption, a cleaner environment, and eradicating health problems. Others have noted we do not know enough about how nanomaterials function, how they add potential stressors to the environment, or what chemical reactions may result when nanomaterials meet other particles. Both groups have called for further debate and advanced research into nanotechnology to determine the balance between risks and benefits. Read more

  • This article analysis the potential consequences of the application of nanotechnology in the Indian context and studies the institutional arrangements for “risk governance” of nanotechnology in other countries. It is argued that nanotechnology governance in India requires a separate agency – similar to the one established for biotechnology – to develop human resources, infrastructure, and research and to monitor issues and concerns in the field. Read more

  • A challenge-facing hazard identification and safety evaluation of engineered nanomaterials being introduced to market is the diversity and complexity of the types of materials with varying physicochemical properties, many of which can affect their toxicity by different mechanisms. Read more

  • According to the report published by BCC Research, the market value of the worldwide nanomedicine industry was $63.8 billion and $72.8 billion in 2010 and 2011, respectively. The market is estimated to grow at a CAGR of 12.5% to reach $130.9 billion by the fiscal year 2016. Read more

  • Food Navigator reports that UK experts are demanding public debate and regulation of nanomaterials in foods.  Without that, they warn, nanotechnology risks “facing the same fate as genetically modified (GM) foods in consumer perceptions.” Read more

  • Workers with existing allergic conditions have worse reactions when exposed to nanoparticles in the workplace, suggest Chinese scientists. They believe that the response is caused by a Trojan horse known as an exosome, which is present in all of us. Read more

  • Source: The Bureau of National Affairs Daily Environment Report (15 Dec 2011) Author(s): Pat Rizzuto. Read more

  • Nanotechnology is an emerging science that offers many new opportunities for the food industry, but food manufacturers should be aware that there are some potential risks with this new technology. Food Manufacturing spoke with Amy Galland of As You Sow about nanotechnology and what processors should consider before implementing this new science into their processes. Read more

  • SAN FRANCISCO - December 21 - Concerned by the growing body of scientific reports cautioning against the unregulated use of nanotechnology in consumer products, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration today. The case is the first lawsuit over the health and environmental risks of nanotechnology and nanomaterials. Read more

  • A coalition of consumer advocacy groups filed suit against the U.S. Food and Drug Administration Wednesday, the latest move in a long effort to force the agency to regulate sunscreens, cosmetics and other products containing super-small particles. Read more

  • The purpose of the OECD Series on the Safety of Manufactured Nanomaterials is to provide up-to-date information on the diverse activities at OECD related to human health and environmental safety. Read more

  • Much of the past decade has been spent worrying about the potential toxicity of nanomaterials. We have had numerous government-funded projects, scores of publications by environmental groups, intense lobbying demanding the labelling of nanomaterials, and even a law suit. But while the developed world agonises over the use of nanomaterials, much of the rest of the world is simply getting on with using them. Read more

  • The United States Environmental Protection Agency (EPA) is charged by Congress to protect the nation’s natural resources. Under the mandate of national environmental laws, the EPA strives to formulate and implement actions leading to a compatible balance between human activities and the ability of natural systems to support and nurture life. To meet this mandate, the EPA’s Office of Research and Development (ORD) provides data and scientific support that can be used to solve environmental problems, build the scientific knowledge base needed to manage ecological resources wisely, understand how pollutants affect public health, and prevent or reduce environmental risks. Read more

  • Nanofilm’s Co-Founder and Chief Executive Officer, Scott Rickert has discussed about six nanotechnology topics to be looked at in the fiscal year 2012 and their impact on the US economy in his nanotechnology column in Industry Week. Read more

  • Intertek Cantox, a company offering regulatory and scientific consulting services, has developed a novel method called the Nano Study Score method to support superior-quality nanotoxicology studies in order to assess the safety of nanomaterial- and nanotechnology-based products. Read more

  • Concerned by the growing body of scientific reports cautioning against the unregulated use of nanotechnology in consumer products, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) today. The case is the first lawsuit over the health and environmental risks of nanotechnology and nanomaterials. Read more

  • The National Institute of Standards and Technology (NIST) has issued the world’s first reference material for single-wall carbon nanotube soot. Distantly related to the soot in your fireplace or in a candle flame, nanotube-laden soot is the primary industrial source of single-wall carbon nanotubes, perhaps the archetype of all nanoscale materials. The new NIST material offers companies and researchers a badly needed source of uniform and well-characterized carbon nanotube soot for material comparisons, as well as chemical and toxicity analysis. Read more

  • In the past decade numerous projects on the risks associated with nanomaterials have been initiated and carried out. In general, they dealt with the subject of how nanomaterials could be used without representing a danger to the environment and human health. However a lack of specialists is preventing further urgently needed studies in the field of nano(eco)toxicology from being undertaken. Read more

  • More than a year after floating the idea, the U.S. Environmental Protection Agency has granted the first approval for a pesticide that’s based on a nanoscale material—a Swiss-made antimicrobial nanosilver product used in fabrics. Read more

  • The European Journal of Law and Technology (EJLT) is a REFEREED open access journal focusing on issues of law and technology in a European context. Read more

  • The rapid emergence and adoption of nanotechnology has provided an opportunity to examine the formation of public opinion on the risks and benefits of a largely unregulated, new and unique technology. Read more

  • A first-of-its-kind framework released on December 6th offers recommendations to food and food packaging companies on how to identify and evaluate nanomaterials in products.  Not only is this technology unregulated and untested for its implications on public health, but companies may not even be aware if they are using products made with nanomaterials. Read more

  • As per the findings from two recent reports on nanotoxicology, most of the studies conducted in the past ten years mainly focused on the application of nanomaterials rather than their risk to the human health and environment. Read more

  • In order to study the toxic effects on skin by zinc oxide nanoparticles, the commonly used ingredient in sunscreen products, a team of researchers from Switzerland and Australia has devised an optical method to quantitatively examine the zinc oxide nanoparticle concentration level at various skin depths. Read more

  • Researchers at the Nanyang Technological University (NTU) have discovered that nanoparticles of zinc oxide, a widely used chemical in consumer products, are capable of causing cancer.  Read more

  • Russian company SUN INNOVATIONS has invented ink with nanoparticles of silver which kill malignant bacteria. Read more

  • A nanoparticle that can destroy drug-resistant bacteria developed by the Institute of Bioengineering and Nanotechnology (IBN), and the IBM Almaden Research Center, has recently been named one of 10 world changing ideas by Scientific American in its Technology Special Report ('World Changing Ideas – 10 New Technologies That Will Make a Difference', December 2011). Read more

  • Experts gather this week to discuss the efficient creation and delivery of nanoscale particles of drugs. From targeted cancer chemotherapy to the guarantee of successful organ transplants, the 21st century may prove to be the age of big ideas in medicine.  Read more

  • A new study from Rensselaer Polytechnic Institute demonstrates how graphene foam can outperform leading commercial gas sensors in detecting potentially dangerous and explosive chemicals. The discovery opens the door for a new generation of gas sensors to be used by bomb squads, law enforcement officials, defense organizations, and in various industrial settings. Read more

  • HUNTINGTON, W.Va. - Recent studies conducted at Marshall University have demonstrated that nanoparticles of cerium oxide—common diesel fuel additives used to increase the fuel efficiency of automobile engines—can travel from the lungs to the liver and that this process is associated with liver damage. Read more

  • WEST LAFAYETTE, Ind. - Purdue University scientists have developed a method for stacking synthetic DNA and carbon nanotubes onto a biosensor electrode, a development that may lead to more accurate measurements for research related to diabetes and other diseases. Read more

  • The healthcare market is poised to see some of the earliest benefits of nanotechnology. Over the next decade, it will be one of nanotech’s highest growth sectors. Targeted drug delivery therapies for the treatment of cancer is one of the most commonly cited nano-healthcare benefits. Read more

  • Researchers make magnetic nanoparticles that can latch on to harmful molecules and purge them from the blood. Read more

  • At first glance, supercomputers, car parts, entertainment systems and radar antennas may not have much in common, but they all stand to benefit from important advances in thermal management technology being achieved by an EU-funded project. Materials developed under the project have been demonstrated in different application sectors, and some are already in use commercially, or likely to be in the near future. Read more

  • Leonardo Biosystems, Inc. and NanoMedical Systems, Inc. (NMS), two emerging drug delivery companies, today announced that they have signed a development contract in which NMS will develop and establish a commercial process to manufacture nanoporous silicon particles for Leonardo's multi-stage drug delivery system.
    "The expertise in the fabrication of massively-parallel nanofluidic structures in silicon gained in the development of our own drug delivery products enables us to support Leonardo in bringing their manufacturing process to a commercial performance level," said Randy Goodall, President and CEO of NanoMedical Systems. "Our medical device engineering quality system is designed to produce an FDA-compliant process that will bring Leonardo to the doorstep of clinical testing of their innovative drug delivery products." Read more

  • One of the problems affecting the human nervous system is dopamine deficiency. But testing of dopamine concentration is costly and requires sophisticated equipment not available in a doctor's office. Enter a team of Polish scientists who developed a method enabling the detection of dopamine in solutions both easily and cheaply, even in the presence of interferences. The study is an outcome of the NOBLESSE ('Nanotechnology, biomaterials and alternative energy source for the European Research Area (ERA))' project, which is backed with EUR 3.3 million under the 'Regions of Knowledge' Theme of the EU's Seventh Framework Programme (FP7). The results are published in the journal Biosensors and Bioelectronics. Read more

  • Market Publishers has released a new market research report titled ‘The World Market for Nanocoatings’ prepared by Future Markets. Read more

  • "Nanotechnology has the potential to create entirely new industries and radically transform the basis of competition in other fields," Rep Honda said.
    "But one of the things I have heard from experts in the field is that while the United States is a leader in nanotechnology research, our foreign competitors are focusing more resources and effort on the commercialization of those research results than we are."
    Rep. Mike Honda (D-Calif.) introduced a bill this month that attempts to boost the federal government's efforts to foster and commercialize research in nanotechnology. Read more

  • The folks over at Future Markets, Inc., a technology consultancy firm, have added several new topics to their series of commercialization charts on nanotechnology and nanomaterials. The charts offer a succinct picture of the level of commercialization for nanotechnoogy and nanomaterials, by application and industry. The currently published charts in the series can be found here. The latest charts deal with applications of nanoclays, graphene and nanocoatings: Read more

  • Researchers at the Purdue University have designed a technology for incorporating carbon nanotubes and synthetic DNA onto a biosensor electrode, paving the way to accurately analyze diabetes and other diseases. Read more

  • Mesocages, hollow spheres and nanowire-shaped metal oxides could help to protect human health and improve the quality of the environment by monitoring and capturing toxic agents. Reporting their results in the journal Nanotechnology, researchers in Japan have come up with a series of designs dubbed nanopackages that pave the way for highly sensitive and selective detection of extremely toxic gases. Read more

  • The newly released educational video on nanoscience called "Does Every Silver Lining Have a Cloud?" features the Duke led Center for the Environmental Implications of NanoTechnology (CEINT) . This video focuses on CEINT researchers discussing their integrated research initiatives that are designed to link fundamental physical and chemical properties of nano-scale materials with their observed biological and ecosystem effects. Read more

  • Is the emerging field of nanomedicine a breathtaking technological revolution that promises remarkable new ways of diagnosing and treating diseases? Or does it portend the release of dangerous nanoparticles, nanorobots or nanoelectronic devices that will wreak havoc in the body? A new review of more than 500 studies on the topic concludes that neither scenario is likely. Read more

  •  TEMPE, Ariz.—As nanotechnology moves (slowly) from the laboratory to the factory, workers are on the front lines—though you wouldn’t know that from the shop floor. Read more

  • Leonardo Biosystems, Inc., an emerging drug delivery company, announced today that it has received the second half of a $2.5 million award from the Texas Emerging Technology Fund (TETF). The initial investment tranche was received in April 2010. Read more

  • Within the framework of FP7 NanoCom we are organising a Nanotechnology Investors Forum in Spring 2012. The specific aim of this forum is to present to selected investors (Business Angels, Venture Capitalists) specific investment opportunities based on nanotechnologies. The forum is a European initiative aimed at facilitating the path to success for spin-offs or start-ups where development has been part funded by a public organisation (European, national, regional). This initiative is also supported by other European nanotechnology related networks and platforms. For more information on EU Nano related networks please visit the NANOfutures platform. Read more

  • Cancer affects about seven million people worldwide, and that number is projected to grow to 15 million by 2020. Most of those patients are treated with chemotherapy and/or radiation, which are often effective but can have debilitating side effects because it's difficult to target tumor tissue. Read more

  • Purdue University scientists have developed a method for stacking synthetic DNA and carbon nanotubes onto a biosensor electrode, a development that may lead to more accurate measurements for research related to diabetes and other diseases. Read more

  • Rice University chemists have found a way to load more than 2 million tiny gold particles called nanorods into a single cancer cell. The breakthrough could speed development of cancer treatments that would use nanorods like tiny heating elements to cook tumors from the inside. Read more

  • Carbon nanomaterials (CNM) are targets of great interest because they have multiple applications in industry but also because of the fear of possible harmful heath effects of certain types of CNM. The high aspect ratio of carbon nanotubes (CNT), a feature they share with asbestos, is likely the key factor for reported toxicity of certain CNT. Read more

  • TEHRAN (FNA)- Seven nanotechnology-based products succeeded in obtaining supply and distribution certificate from Iran's Ministry of Health, Treatment and Medical Education. Read more

  • Show of hands: who would like to see computers that are smaller and more powerful? Or a cancer therapy that precisely targets only cancer cells? Or foods with better nutritional value? Or packaging that keeps food fresher and bacteria free for longer? Nanotechnology promises to do all this … and more! Read more

  • Around 160 researchers from 26 nations have participated in the 2011 International Symposium on Clusters and Nanostructures conducted by the Virginia Commonwealth University (VCU) at the Jefferson Hotel in Richmond to address the function of nanostructures and clusters in resolving the issues faced by health, environment and energy. Read more

  • The past few years has seen an explosion of interest in silver nanoparticles.  Along with a plethora of products using the particles to imbue antimicrobial properties on everything from socks to toothpaste, nanometer scale silver particles have been under intense scrutiny from researchers and policy makers concerned that they present an emerging health and environmental risk. Read more

  • The MARINA project is a major new European Commission Framework 7 project to develop reference methods for managing the risk of engineered nanoparticles and engineered nanomaterials (ENM).With very significant economic impact across industrial, consumer and medical products, nanotechnology is now one of the key industries within Europe and worldwide. Key to its long term growth and sustainability is establishing end-user confidence that the technologies developed are safe. Read more

  • Nanoparticles such as carbon nanotubes (CNT), which are found in an ever-increasing number of products, are ending up more and more frequently in our surroundings. If and how they affect aquatic ecosystems are questions which are still unanswered. An Empa study shows that while CNTs do not have toxic effects on green algae they do inhibit its growth by depriving the plant of light and space. Read more

  • Inside a laboratory in College Station, Tex., Jaime Grunlan and his students are building a new way to keep food fresh, brick by super-tiny brick. Using clay and biodegradable, food-safe polymers, they’re making what are effectively walls on an atomic scale. Read more

  • Researchers at the University of Copenhagen are behind the development of a new method that will make it possible to develop drugs faster and greener. This will lead to cheaper medicine for consumers. Read more

  • Iranian researchers at University of Malayer and Material and Energy Research Institute of Iran used a layer nanohybrid compound to synthesize copper porous metallic nanopowder and they succeeded in the production of copper meso-porous nanopowder as well as carbonic microporous nanoparticles. Read more

  • (NHI Nanoblog) The National Nanotechnology Initiative (NNI) has released its latest blueprint for fostering the safe development of nanotechnology, giving fresh emphasis to the idea of studying a product or application from birth to death. Read more

  • Sometimes the seeming conflict between the overflowing optimism for nanotechnology and then the biting skepticism aimed at it creates confusion in its wake. Read more

  • Nanotechnology has the potential to lead to healthier, safer and better tasting foods, and improved food packaging, but the hesitation of the food industry and public fears in some countries about tampering with nature may be holding back the introduction of nanofoods. Read more

  • Under the header of Communicating Nanoethics, ObservatoryNano aims to highlight key findings and developments in current dialogues and public engagement activities at EU level and in Member States and other countries. This way, emerging issues not discussed sufficiently and best practices in communication on ethical and societal aspects of nanotechnology can be identified and brought to the attention of policy makers in the fourth annual report on communicating nanoethics to be published online in the spring of 2012. Read more

  • Consumer groups and Lausanne University have launched a campaign to raise awareness of nanotechnology – its potential, but also possible risks to health and the environment. Read more

  • Biotechnology companies have expressed general support for FDA's draft guidance defining whether products contain nanomaterials or otherwise involve the application of nanotechnology. But the sector also made its case for less red tape and more leeway, raising issue with some specifics and asking for clarity on other topics. Read more

  • Presentation slides from the modules for the training Course: Introduction to Nanomaterials and Occupational Health, developed under a grant from the Occupational Safety and Health Administration (OSHA), can be viewed and downloaded at the GoodNanoGuide website. Read more

  • Carboxylated carbon nanotubes stand as the most promising nanovectors for biomedical and pharmaceutical applications due to their ease of covalent conjugation with eclectic functional molecules including therapeutic drugs, proteins, and oligonucleotides. In the present study, we attempt to investigate how the toxicity of acid-oxidized multiwalled carbon nanotubes (MWCNTs) can be tweaked by altering their degree of functionalization and correlate the toxicity trend with their biodistribution profile. Read more

  • Queensland University of Technology (QUT) researchers have developed new technology capable of removing radioactive material from contaminated water and aiding clean-up efforts following nuclear disasters. The innovation could also solve the problem of how to clean up millions of tonnes of water contaminated by dangerous radioactive material and safely store the concentrated waste. Read more

  • Nanotechnology is one of today's most promising technological developments. The activities of the Joint Research Centre supporting safety assessment of nanomaterials (as shown in this video, issued in October 2011) are aimed at ensuring consumer protection and confidence in many innovative applications and products. Read more

  • Biotechnology companies have expressed general support for FDA's draft guidance defining whether products contain nanomaterials or otherwise involve the application of nanotechnology. But the sector also made its case for less red tape and more leeway, raising issue with some specifics and asking for clarity on other topics. Read more

  • Pick your poison from this smorgasbord of recent salmonella outbreaks in the United States: ground turkey; fresh papayas; alfalfa sprouts. That's in 2011 alone, and the list goes on, according to the U.S. Centers for Disease Control and Prevention. But perhaps not for long, thanks to a promising new biosensor nanotechnology that could identify the presence of salmonella bacteria before contaminated food or animals reach the marketplace. Read more

  • Commenting on the third quarter results, president and chief executive officer Dr. Timothy J. Stultz said, "In a challenging industry environment and rapidly changing business dynamics, we delivered a strong third quarter, in line with the guidance we provided in late July. As we entered the third quarter, we began to see shifting priorities in the semiconductor industry... Read more

  • Health and environmental impacts of graphene-based materials need to be thoroughly evaluated before their potential applications. Graphene has strong cytotoxicity toward bacteria. To better understand its antimicrobial mechanism, we compared the antibacterial activity of four types... Read more

  • EUGENE, Ore. -- (Oct. 24, 2011) -- If you've ever eaten from silverware or worn copper jewelry, you've been in a perfect storm in which nanoparticles were dropped into the environment, say scientists at the University of Oregon. Read more

  • According to a new article published in Small, researchers at South China Normal University demonstrated that phototherapy using a laser light focused on implanted SWeNT Single-walled carbon nanotubes (SWCNTs) will selectively destroy the target mitochondria. Read the rest of the article.

  • While I was attending the EuroNanoForum 2011 conference earlier this year, I ran into old acquaintance who works at a national nanotechnology laboratory. Read the rest of the article.

  • Translation of the original article written in French available here) This Tuesday, October 18, the European Commission published its long-awaited definition of nanomaterials after a year of intense negotiations. The reactions were not long in coming, revealing power struggles so far mainly confined to Brussels area.  Read more

  • This year I have been covering the sometimes-laughable efforts by the European Commission to define what a nanomaterial is in order for them to develop a regulatory framework. Read more

  • The European Commission had just adopted a “cross-cutting designation of nanomaterials to be used for all regulatory purposes” (link). The definition builds on a draft definition released last year, but includes a number of substantial changes to this. Read more

  • The term ‘nanotechnology’ covers a very broad range of entities and industrial applications. It is expected that many of the applications will help to improve human health and quality of life. The medical application of nanotechnology is probably one of the fastest growing fields, with developments in therapeutic, diagnostic and imaging uses (e.g. in cancer). Read more

  •  

    During a joint event held in Brussels today, the European Commission's Joint Research Centre (JRC) and the European Academies Science Advisory Council (EASAC) presented the findings of a joint report entitled "Impact of engineered nanomaterials on health: considerations for benefit-risk assessment" (for download, see below). The report summarises the state-of-the-art knowledge on the safety of engineered nanomaterials and concludes that there is only limited scientific evidence to suggest that nanomaterials present a risk for human health. Read more

  • "Nanomaterials" are materials whose main constituents have a dimension of between 1 and 100 billionth of a metre, according to a pdf icon Recommendation on the definition of nanomaterial adopted by the European Commission today (*). The announcement marks an important step towards greater protection for citizens, clearly defining which materials need special treatment in specific legislation. Read more

  • [October 18th, Brussels] - The European Environmental Bureau (EEB) is deeply disappointed by the European Commission’s decision released today to use a narrow definition for the term “nanomaterial”, indicating that industry lobbying has won over the Commission’s own scientific advisors [1]. EEB did however welcome the fact that a recommendation was adopted and hopes this will clear the way for the EU to actually start regulating on this. Read more

  • Nanotechnology holds the promise of new materials and devices that can be designed and engineered to solve critical questions in almost every sector of our economy – from treating cancer, to cleaning contaminated water, accelerating advanced manufacturing, meeting energy needs, and fixing our roadways and bridges. That's why, for the last 10 years, the United States has engaged in an ambitious effort through the National Nanotechnology Initiative (NNI) to leverage the research programs and resources of Federal agencies and maximize the potential for translating the results of nanotechnology research into products that strengthen the economy and improve our quality of life. Read more

  • Products that incorporate materials manufactured at the nano scale (i.e., nanoproducts) offer many potential benefits to society; however, these benefits must be weighed against potential “costs” to the environment and public health. Read more

  • The latest iteration of the US National Nanotechnology Initiative’s Environmental, Health and Safety Research Strategy was released today – downloadable from nano.gov. A draft of the document has been on the streets since last December – this version was compiled after a public comment period on that draft that closed earlier this year (the key comments received are listed here). Read more

  • The Federal Government today released a national strategy for ensuring that environmental, health, and safety research needs are fully identified and addressed in the fast-growing field of nanotechnology. Read more

  • During a joint event held in Brussels today, the European Commission's Joint Research Centre (JRC) and the European Academies Science Advisory Council (EASAC) presented the findings of a joint report entitled "Impact of engineered nanomaterials on health: considerations for benefit-risk assessment" (for download, see below). The report summarises the state-of-the-art knowledge on the safety of engineered nanomaterials and concludes that there is only limited scientific evidence to suggest that nanomaterials present a risk for human health. Read more

  • [October 18th, Brussels] - The European Environmental Bureau (EEB) is deeply disappointed by the European Commission’s decision released today to use a narrow definition for the term “nanomaterial”, indicating that industry lobbying has won over the Commission’s own scientific advisors [1]. EEB did however welcome the fact that a recommendation was adopted and hopes this will clear the way for the EU to actually start regulating on this. Read more

  • This year I have been covering the sometimes-laughable efforts by the European Commission to define what a nanomaterial is in order for them to develop a regulatory framework. Read more

  • The European Commission had just adopted a “cross-cutting designation of nanomaterials to be used for all regulatory purposes” (link). The definition builds on a draft definition released last year, but includes a number of substantial changes to this. Read more

  • The round-shaped tip of a carbon nanotube fools a cell into ingesting it, to death. A rough-hewn end may fix the problem. Christopher Intagliata reports. Read more

  • I witnessed an American revolution catch fire in Boston, and I feel like a latter-day Paul Revere. "The nanotech economy is coming, the nanotech economy is coming!" and that's good news for the U.S. -- and you -- because we're at the epicenter. Read more

  • This coming Thursday (Oct 20 2011), the US National Nanotechnology Initiative is releasing the latest version of the Initiative’s federal nanotechnology environmental, health and safety research strategy.  The strategy will be available for download from 10:00 AM Eastern time, with a webinar on the release being held between 12:00 PM – 12:45 PM Eastern (registration required). Read more

  • Back in 2008 we reported on nanotechnology solution for radioactive waste cleanup, specifically the use of titanate nanofibers as absorbents for the removal of radioactive ions from water. Now, the same group that developed these nanomaterials reports in a new study that the unique structural properties of titanate nanotubes and nanofibers make them superior materials for removal of radioactive cesium and iodine ions in water. Read more

  • Prior to Congress adjournment for the traditional August recess, Rep. Mike Honda (CA-15th-D) introduced H.R. 2749, "The Nanotechnology Advancement and New Opportunities (NANO) Act", described by Rep. Honda as ". . .a comprehensive bill to promote the development and responsible stewardship of nanotechnology in the United States . . . .[drawing] upon th work of the Bluee Ribbon Task Force on Nanotechnology . . . Read more

  • Denmark's Environmental Protection Agency (DEPA)  recently released "Survey on basic knowledge about exposure and potential environmental and health risks for selected nanoparticles". The survey was written by Sonja Hagen Mikkelsen, Erik Hansen and Trine Boe Christensen of COWI A/S, Anders Baun and Steffen Foss Hansen of DTU Environment and Mona-Lise Binderup of DTU Food, all working under contract with DEPA. Read more

  • The novel characteristics of nanomaterials mean that risk assessments developed for ordinary materials may be of limited use in determining the health and public safety of products based on nanotechnology. Read more

  • NICNAS, the National Industrial Chemicals Notification and Assessment Scheme of the Australian Government regulator of industrial chemicals, commissioned a review and analysis available literature from 2007-2009 on six industrial nanomaterials, chosen as they were considered to already be in, or close to, commercial use in Australia. Read more

  • The fate and behavior of nanomaterials (NMs) in environmental media has important consequences for toxicity. The majority of aquatic research to date has focused on NM behavior in freshwater systems. Read more

  • With today's advancements in technology, we can engineer virtually everything from animals to our children. Now, we can even engineer "better" versions of ourselves. Nanotechnology, the manipulation of matter on atomic and molecular levels, may transform the cars we drive to the medical treatments we receive. Read more

  • Nanomaterials are now used in many different economic sectors and increasingly also in consumer products such as cosmetics, textiles, and food packaging. The possible consequences of this use have not been sufficiently studied. There is a danger of a widening gap between the technological development and the knowledge about risks. Read more

  • A decision-directed approach for prioritizing research into the impact of nanomaterials on the environment and human health. Read more

  • With political action on curbing greenhouse gases stalled, a bipartisan panel of scientists, former government officials and national security experts is recommending that the government begin researching a radical fix: directly manipulating the Earth’s climate to lower the temperature.  Read more

  • With hundreds of nanoproducts currently being tested in humans, recommendations aim to safeguard trial participants. Read more

  • From medicine and energy to material science and prevention of bioterrorism, nano-technology developments are occurring at a rate faster than even the field’s most optimistic proponents predicted only a few years ago. Read more

  • New cures for cancer... more efficient solar cells... even quicker and smaller computers... more energy-efficient lighting. Nanotechnology has huge potential in these and other fields, but there are also risks. And no-one can say whether the risks are enormous, or in fact quite small. Read more

  • Important elements in these new approaches include life-cycle thinking, public participation and adaptive management of the risks associated with emerging technologies and new materials. Read more

  • The novel characteristics of nanomaterials mean that risk assessments developed for ordinary materials may be of limited use in determining the health and public safety of products based on nanotechnology. Read more


     
  • Research and Markets has added the report titled,The World Market For Nanotechnology: Nanomaterials, Markets and Companies 2011, to their offering. Read more

  • Online Research Company, Research and Markets has released a report titled, “Global Funding of Nanotechnologies- 2011 Edition”. The investment into nanotechnology research by various governments world- wide over the last 11 years is more than US$ 67 billion. This includes funding for researches that are in various stages namely translation stage, basic stage that require investment in instruments, facilities and other services. Read more

  • A study by researchers from the schools of science and medicine at Indiana University-Purdue University Indianapolis examines the effects of carbon nanoparticles (CNPs) on living cells. This work is among the first to study concentrations of these tiny particles that are low enough to mimic the actual exposure of an ordinary individual. Read more

  • A new report released by Friends of the Earth (FoE) reveals experts believe that widespread use of nano-silver could breed superbugs, leading to more Australian deaths in hospitals. Antibiotic resistant bacteria (superbugs) in our hospitals claim over 7,000 Australian lives each year. Public health experts have called this one of the greatest health threats of our time. Read more

  • As super-small particles and materials become increasingly common in manufacturing, how are companies dealing with the potential to expose their workers to invisible hazards? Read more

  • A study by researchers from the schools of science and medicine at Indiana University-Purdue University Indianapolis examines the effects of carbon nanoparticles (CNPs) on living cells. This work is among the first to study concentrations of these tiny particles that are low enough to mimic the actual exposure of an ordinary individual. Read more

  • It's been long known that asbestos spells trouble for human cells. Scientists have seen cells stabbed with spiky, long asbestos fibers, and the image is gory: Part of the fiber is protruding from the cell, like a quivering arrow that's found its mark. Read more

  • In a recent letter to the journal Nature (Nature 476; 399), Hermann Stamm of the European Commission Joint Research Centre Institute for Health and Consumer Protection (JRC-IHCP) defended the need to define engineered nanomaterials for regulatory purposes. The letter, titled “Nanomaterials should be defined”, was a direct response to my earlier commentary in Nature “Don’t define nanomaterials”. Read more

  • It is quite difficult – not least because there is no consensus about a proper definition – to assess the scope of nanotechnology research and its impact on the overall scientific body as well as its commercialization prospects. In a new attempt to put some numbers behind the general perception of a rapidly expanding nanotechnology field, two researchers at UC Davis have trawled scientific databases and come up with some surprising findings.  Read more

  • The Danish Environmental Protection Agency (DEPA) has initiated the study "Survey on basic knowledge about exposure and potential environmental and health risks for selected nanomaterials". The objective of the study is to provide an overview of the applications of the most commonly used or widespread nanomaterials and to identify areas most likely to have health or environmental problems associated with their use. Read more

  • Probably the leading team that is driving forward the work on nanogenerators for converting mechanical energy into electricity is Zhong Lin Wang's group at Georgia Tech. So far, we have covered their exciting work in at least half a dozen Nanowerk Spotlights about nanopiezotronics and nanogenerators. Read more

  • A study by researchers from the schools of science and medicine at Indiana University-Purdue University Indianapolis examines the effects of carbon nanoparticles (CNPs) on living cells. This work is among the first to study concentrations of these tiny particles that are low enough to mimic the actual exposure of an ordinary individual. Read more

  • Recent calls to place warning labels on nano sunscreens are ill advised, says Paul Wright, especially in a country with such a high incidence of skin cancer. Read more

  • As super-small particles and materials become increasingly common in manufacturing, how are companies dealing with the potential to expose their workers to invisible hazards? Read more

  • In 2010 the first baby boomers reached official retirement age and an additional 10,000 join the ranks on a daily basis(1). The influx of these 78 million retirees over the next 20 years will dramatically change the U.S. age profile and put a heavy burden on both the retirement and Medicare system. Read more

  • A forecasted rise in industrial demand for silver from various emerging sectors is often cited by bullish silver analysts as a strong supporting factor — alongside increasing investment demand, of course — for a rosy long-term outlook in the silver market. Read more

  • Nanoparticle Safety: Excreted nanoparticles containing drugs could pose a threat in the environment. Read more

  • Denmark's Environmental Protection Agency (DEPA)  recently released "Survey on basic knowledge about exposure and potential environmental and health risks for selected nanoparticles". The survey was written by Sonja Hagen Mikkelsen, Erik Hansen and Trine Boe Christensen of COWI A/S, Anders Baun and Steffen Foss Hansen of DTU Environment and Mona-Lise Binderup of DTU Food, all working under contract with DEPA. Read more


     
  • In a recent letter to the journal Nature (Nature 476; 399), Hermann Stamm of the European Commission Joint Research Centre Institute for Health and Consumer Protection (JRC-IHCP) defended the need to define engineered nanomaterials for regulatory purposes. The letter, titled “Nanomaterials should be defined”, was a direct response to my earlier commentary in Nature “Don’t define nanomaterials”. Read more


     
  • Prior to Congress adjournment for the traditional August recess, Rep. Mike Honda (CA-15th-D) introduced H.R. 2749, "The Nanotechnology Advancement and New Opportunities (NANO) Act", described by Rep. Honda as ". . .a comprehensive bill to promote the development and responsible stewardship of nanotechnology in the United States . . . Read more

  • It is quite difficult – not least because there is no consensus about a proper definition – to assess the scope of nanotechnology research and its impact on the overall scientific body as well as its commercialization prospects Read more

  • Developing countries forging ahead with nanotechnology need regulation and research into local risk patterns, say Alok Dhawan and Vyom Sharma. Read more

  • The Safety Research WG - chaired by Dr Rob Aitken, Director of SAFENANO and Strategic Consulting at the Institute of Occupational Medicine (IOM) - aims to improve knowledge concerning the risks exposure/toxicology/safety/impact, particularly in relation to risk assessment and to contribute to promote safe, sustainable and socially responsible nanotechnology. Read more

  • Tasked with the core responsibility of protecting and promoting the health and safety of Americans through enhancing the availability of safe medical products and foods, the U.S. Food and Drug Administration (FDA) recently released a document titled Advancing Regulatory Science at FDA: A Strategic Plan. Read more

  • Nanomaterials offer numerous new opportunities for innovation but they can also pose new risks. Nanomaterials are now used in many different economic sectors and increasingly also in consumer products such as cosmetics, textiles, and food packaging. The possible consequences of this use have not been sufficiently studied. There is a danger of a widening gap between the technological development and the knowledge about risks. Read more

  • Green Chemistry experts have developed a roadmap to ensure emerging nanotechnologies are safe for use by humans before they are introduced into the marketplace. Read more

  • The unregulated nanotech industry is spreading through the U.S. food system. Read more

  • Lotions containing inorganic nanoparticles draw attention of toxicologists and ire of some consumer groups. Read more

  • The latest edition of the report, “Developments in Nanotechnologies Regulation and Standards 2011” has been published. The report is part of the European Commission’s ObservatoryNANO project, and is an evolving document meant to keep pace with changes in the regulatory landscape.

    Read more

  • Irene A. Hantman - a legal fellow with the United States Environmental Protection Agency and vice chair, membership, of the American Bar Association Committee on Pesticides, Chemical Regulation, and Right to Know - has authored an article for the Bureau of National Affairs (BNA) Daily Environment Report that explores nanotechnology regulatory policy Read more

  • Lab experiments find that nickel particles with diameters billionths of a meter wide can trigger a cellular pathway that promotes cancer growth.  Read more

  • With the curtain about to rise on a much-anticipated new era of “nanoagriculture” — using nanotechnology to boost the productivity of plants for food, fuel, and other uses — scientists are describing huge gaps in knowledge about the effects of nanoparticles on corn, tomatoes, rice and other food crops. Read more

  • Andrew Maynard argues against defining engineered nanomaterials for regulatory purposes. Read more

  • The range of food and agricultural nanotechnology applications includes making toxins more bio-available in pesticides, targeting nutrients in smaller doses, improving the texture of ice cream and detecting bacteria in packaged foods. Read more

  • Nanotechnology has wide applications in many fields, especially in the biological sciences and medicine. Nanomaterials are applied as coating materials or in treatment and diagnosis. Read more

  • The National Nanotechnology Initiative's (NNI) released four reports today that are the result of a series of workshops focusing on various issues in the nanotechnology environmental, health, and safety (EHS) arena. Read more

  • The materials that most current regulations were designed to handle are pretty simple by today’s standards. Sure they can do some nasty things to the environment or your body if handled inappropriately. And without a doubt some of the risks associated with these “simple” materials are not yet well understood – especially when it comes to long term and trans-generational impacts. Read more


     
  • High profile Australian sunscreen brand Invisible Zinc has been told to remove "not nano" labelling from its website by the sunscreens regulator because they are allegedly scaring the public.High profile Australian sunscreen brand Invisible Zinc has been told to remove "not nano" labelling from its website by the sunscreens regulator because they are allegedly scaring the public. Read more

  • Commissioner Máire Geoghegan-Quinn announced nearly €7 billion to kick-start innovation through research. The European Commission's biggest ever such funding package, under the EU's Seventh Framework Programme for Research (FP7), is expected to create around 174 000 jobs in the short-term and nearly 450 000 jobs and nearly €80 billion in GDP growth over 15 years. Read more

  • The Government is set to disappoint consumers who are worried about the use of nanotechnology in sunscreens, with documents obtained by PM showing the Government will not opt for mandatory labelling. Read more

  • BUFFALO, N.Y. -- Quantum dots made from cadmium and selenium degrade in soil, unleashing toxic cadmium and selenium ions into their surroundings, a University at Buffalo study has found. Read more

  • CVD Equipment, a company that designs and manufactures graphene, semiconductors, carbon nanotubes, MEMS, nanowires, and industrial coatings, received orders of nearly $24.6M for the first six months of 2011. Read more

  • Cientifica, the worlds most respected nanotechnology information and forecasting company has just released the much anticipated 2011 report on global nanotechnology funding and impact. Read more

  • In the late 1950s, Richard Feynman famously imagined a science where researchers and engineers could achieve remarkable feats by manipulating matter and creating structures all the way down to the level of individual atoms. Read more

  • Some nanotechnology experts have pushed for more explicit guidelines in the nanotechnology field because it would help spur innovation and commercialization. Read more

  • Nanotechnology promises great advances for a host of industries, but concerns about health and safety threaten commercialization efforts. Read more

  • The recent new focus on safety and environment isn't a death knell, just growing pains. Read more

  • Federal guidelines proposed June 9 for the regulation and oversight of products containing engineered nanoscale materials have gotten a mixed reception from affected industries. The government policies aim to protect public health and the environment without stifling innovation, but some stakeholders see room for improvement. Read more

  • Electronics.Ca Publications has released a new report titled "Graphene: Technologies, Applications, and Markets". According to a new market research report, the market value for graphene-based products worldwide will be estimated at a value of $67 million in 2015 and is expected to rise to $675.1 million in 2020. The compound annual growth rate (CAGR) of graphene-based products is estimated to be at 58.7%. Read more

  • Researchers from Applied Sciences Inc., a world leader in advanced materials, say carbon nanotubes are ideal materials to pair with nano-sized self-healing capsules in thermoset composites. Applied Sciences is exploring this technology under a NASA Phase I SBIR program targeted at developing self healing composite technology using Pyrograf III carbon nanotubes. Read more

  • Research and Markets has added a report titled "Nanomaterials Market in the US" to its catalogue. The US is a market leader for nanomaterials. By 2018, it is anticipated that traditional nanomaterials such as polymers will generate the majority of demand in the nation. Read more

  • A novel application of carbon nanotubes, developed by MIT researchers, shows promise as an innovative approach to storing solar energy for use whenever it's needed. Read more

  • Research and Markets has added a report titled "Carbon Nanotubes and Graphene for Electronics Applications 2011-2021" to its offering. Read more

  • The new 2011 edition of Nanotechnology Law published by West/Thomson/Reuters is now out.  I update the book every year and the new edition has lots of new stuff.  They make excellent Christmas and Birthday gifts, and are a general cure for insomnia.  All proceeds go to my underprivileged daughters' college fund.  Everyone should have one (or two). 


    Read more: at www.nanolawreport.com
  • Graphene, a form of pure carbon arranged in a lattice just one atom thick, has interested countless researchers with its unique strength and its electrical and thermal conductivity. But one key property it lacks — which would make it suitable for a plethora of new uses — is the ability to form a band gap, needed for devices such as transistors, computer chips and solar cells. Read more

  • The focus of intense scientific research in recent years, graphene is a two-dimensional material, comprised of a single layer of carbon atoms arranged in a hexagonal lattice. It is the strongest material ever measured and has other remarkable qualities, including high electron mobility, a property that elevates its potential for use in high-speed nanoscale devices of the future. Read more

  • During the past 20 years, multiwall carbon nanotubes (MWCNTs) have become an important industrial material. Hundreds of tons are produced each year. This review is a survey of the scientific literature, motivated by industrial requirements and guidelines for environment, health and safety compliance. Read more

  • Aquatic sediments form an important sink for manufactured nanomaterials, like carbon nanotubes (CNT) and fullerenes, thus potentially causing adverse effects to the aquatic environment, especially to benthic organisms. Read more

  • Electronics.Ca Publications has released a new report titled "Graphene: Technologies, Applications, and Markets". According to a new market research report, the market value for graphene-based products worldwide will be estimated at a value of $67 million in 2015 and is expected to rise to $675.1 million in 2020. The compound annual growth rate (CAGR) of graphene-based products is estimated to be at 58.7%. Read more

  • Super-small carbon materials are relatively new. Regulators in the United States, and internationally, want new materials and products tested for safety. That testing is expensive and time-consuming. Read more

  • Nanotechnology promises great advances for a host of industries, but concerns about health and safety threaten commercialization efforts. Read more

  • A team of researchers in Germany has brought some good news to the debate on nano-material safety. The team took four materials containing nanoparticles or nanotubes and subjected them to high speed sanding, gentle abrasion and UV radiation, and found that the resulting dust was no finer than that from conventional materials. What's more, rats exposed to the fine dust fared no worse whether the material contained nano-components or not. Read more

  • PORTLAND, Ore.—Nanotubes may not be toxic, as previously reported elsewhere, according to the Semiconductor Research Corp.  (SRC). Rather, contaminants mixed in during their manufacture should be credited with their adverse health effects, according to a University of Texas study funded by SRC. Read more

  • NEW ORLEANS -- More than 15,000 food scientists, chefs, recipe developers and purveyors of spices, flavorings and additives met here last week to examine the newest innovations in the cook's pot and on grocery shelves. Read more

  • Europe is once again trying to appease…umh…I mean inform the public about the subject of nanotechnology with another public outreach program entitled Nanochannels. Read more

  • Tiny fibres used to strengthen items such as bike frames and hockey sticks could pose risks to workers who make them. Read more

  • The Netherlands delegation submitted a paper entitled “Risks associated with nanomaterials for discussion during the June 21, 2011, meeting of the Environment Council of the European Union (EU).  The paper states that, under current EU legislation and the precautionary principle, “industry bears primary responsibility for the safety of its products for workers and consumers.” Read more

  • As researchers and regulators focus on how to safely make, sell and use carbon nanotubes, Philip Wallis is working to apply each new lesson to his own workforce—and his customers. Read more

  • The scene around nanotechnology regulatory frameworks has been frantic (by comparison with any other time period during the 3 years I’ve been blogging about nano) in the last month or so. This is my second attempt this month at pulling together information about nanotechnology regulatory frameworks. Read more

  • WASHINGTON, D.C.—The U.S. Food and Drug Administration’s newly released sunscreen rules fail to meaningfully consider the risks posed by nanoscale ingredients, according to public interest groups including Friends of the Earth, The International Center for Technology Assessment and Consumers Union. Read more

  • More than 1,300 products now on the market claim to incorporate Engineered Nanomaterials (ENMs), whose very tiny size yields novel properties, such as making products, lighter, stronger, and better able to retain moisture and deliver pesticides. None of these products have undergone a pre-market safety assessment. Read more

  • nanoTox Inc. and AssuredNano Limited announce today that they have concluded an agreement which will lead to a merger of the two companies creating a global Environmental, Health & Safety (EHS) Standard for engineered nanomaterials. The integration of these two well established brands will provide global coverage for all issues relating to the occupational hygiene and toxicology of nanomaterials and nano-enabled products. Read more

  • Readers may be interested in learning about a new subscription website devoted to nanoscale carbon -- Read more


     
  • The removal of oxidation debris from the oxidized carbon nanotube surface with a NaOH treatment is a key step for an effective functionalization and quality improvement of the carbon nanotube samples. Read more

  • Major barriers to delivery of biomolecules are crossing the cellular membranes and achieving a high cytoplasmic concentration by circumventing entrapment into endosomes and other lytic organelles.

    Read more

  • Absorption is expected to be poor via all routes for the carbon nanotubes based on test data for
    chemicals with similar molecular structures and chemicals with similar physical/chemical
    properties. Read more

  • Nanomaterials such as multi-walled carbon nanotubes (MWCNTs) are applied to various industrial products and thus may be released to soils, but their potential environmental impacts remain largely undetermined. Read more

  • Our data demonstrate that multi-walled carbon nanotubes (MWCNTs) are internalized by macrophages, subsequently activating them to produce interleukin (IL)-12 (IL-12). Read more

  • Carbon nanomaterials have multiple applications in various areas. However, it has been suggested that exposure to nanoparticles may be a risk for the development of vascular diseases due to injury and dysfunction of the vascular endothelium. Read more

  • Super-small carbon materials are relatively new. Regulators in the United States, and internationally, want new materials and products tested for safety. That testing is expensive and time-consuming.

    Read more

  • The fibrous shape of carbon nanotubes (CNTs) raises concern that they may pose an asbestos-like inhalation hazard, leading to the development of diseases, especially mesothelioma. Read more

  • As a novel kind of nanomaterial with wide potential applications, the adverse effects of carbon nanotubes (CNTs) have recently received significant attention after respiratory exposure.
  • Carcinogenicity of carbon nanotubes is a major concern but has not been well addressed due to the lack of experimental models. Read more

  • It must be Nanotechnology Regulation week in Washington DC.  Yesterday, two federal agencies and the White House released documents that grapple with the effective regulation of products that depend on engineered nanomaterials.

    Read more

  • During the past 20 years, multiwall carbon nanotubes (MWCNTs) have become an important industrial material. Hundreds of tons are produced each year. This review is a survey of the scientific literature, motivated by industrial requirements and guidelines for environment, health and safety compliance.

    Read more

  • A recent study conducted in conjunction with the Division of Endocrinology at the Brown Medical School Department of Medicine in Providence, Rhode Island has found that the most common causes of granulomatous inflammation are persistent pathogens and poorly-degradable irritating materials, such as nanoparticles and asbestos. Read more

  • An oversight system specifically concerned with nanomaterials should be flexible enough to take into account the unique aspects of individual novel materials and the settings in which they might be used, while recognizing that heretofore unrecognized safety issues may require future modifications. This article considers a question not explicitly considered by the project team: what is the risk that uncertainty over how regulatory oversight will be applied to nanomaterials will delay or block the development of this emerging technology, thereby depriving human health of potential and substantial benefits? Read the full study

  • A few weeks ago, the US National Nanotechnology Initiative website, www.nano.gov, underwent a much-needed facelift.  The NNI’s web portal was creaky when I was part of the Initiative several years ago now.  And it’s somewhat ironic that the world’s leading interagency initiative on one of the most prominent cutting edge technology platforms has relied on a website that is the antithesis of technology innovation for over a decade.  So I was pleasantly surprise to see the other week that the site has been updated, streamlined, and made more accessible, attractive, and – dare I say – useful.

  • Depending on whom you ask, nanoparticles are, potentially, either one of the most promising or the most perilous creations of science. These tiny objects can deliver drugs efficiently and enhance the properties of many materials, but what if they also are hazardous to your health in some way? Now, scientists at the National Institute of Standards and Technology (NIST) have found* a way to manipulate nanoparticles so that questions like this can be answered. Read the full article

  • This Policy Brief addresses the need for a governance response from the European bodies to
    establish a registry of nanomaterial-containing articles. Better comprehensive data is urgently
    needed to improve knowledge of what is on the market, who is exposed and what should be
    regulated. Member States welcome such inventories and have developed their own initiatives
    while at the same time exhorting the European Commission to step in on the process. Achieving
    harmonisation of the national initiatives is crucial, for proper regulation is needed to ensure proper protection of human and environmental health, as well as an adequate level of risk management. Read the brief --

  • Check the label on a sunscreen for sale in this Whalley Avenue pharmacy aisle, and you’ll get advice for applying it, a warning not to get it in your eyes and a list of ingredients.

    You won’t learn whether the lotion contains newfangled super-tiny particles.

    That’s a problem, according to consumer and environmental advocates who keep tabs on the burgeoning field of nanotechnology. Read more

  • ISO has announced new general liability classifications for alternative energy sources and nanotechnology. ISO is introducing most of the new classifications with accompanying estimated loss potentials. Read more

  • This document provides a snapshot of information on current/planned activities related to the safety of manufactured nanomaterials in OECD member countries and other delegations that attended the 8th meeting of OECD’s Working Party on Manufactured Nanomaterials (Paris France, 16-18 March 2011). There are also written reports on current activities from other International Organisations such as the ISO, the FAO and the WHO. Read more

  • For those who might like a small primer on the topic, the EU believed it necessary to define what nanotechnology is before developing regulations for it and it all seemed to make sense until the process got stuck in the mud on the issue of “how much” or “how many” nanoparticles. Read more

  • In December 2009 the German Federal Institute for Risk Assessment (BfR) published an opinion advising against use of nanosilver in food and everyday products.  Industry and other groups, including the Silver Nanotechnology Working Group (SNWG), repeatedly requested BfR to reconsider this extreme position and BfR subsequently organized a workshop ostensibly to consider alternative views on nanosilver.  Despite BfR assurances that follow-up dialogue would occur after the workshop, BfR subsequently issued a press release re-stating the original position of the initial opinion. This re-stating of the original opinion essentially ignores the facts presented to BfR during the workshop. Read to comments

  • On May 3rd and 4th, representatives of ministries, agencies, industry, science and civil organisations from Germany, Austria, Switzerland and Liechtenstein met in Berlin at the invitation of the German Federal Ministry for the Environment, Nature Conservation and Nuclear Safety to discuss current developments in the governance of nanotechnologies. The main topics discussed at the 5th International Nano Authorities Dialogue were the results of the NanoKommission Germany 2009-2011 as well as ongoing national and international developments in regulation, registration and information transfer regarding nanomaterials of those countries participating in the Dialogue. The Authorities Dialogue has been organised by the Innovation Society, St.Gallen, since 2008 in cooperation with the German-speaking authorities and ministries in the area of health and the environment.  Read more

  • Among the scores of researchers hustling to study the impact of nanotechnology on people, animals and the environment, a debate is growing: How much of the super-small stuff should they use to test for safety? Read the entire article

  • Report of a 2-day workshop organised in April 2010 by the IHCP Nanobiosciences Unit (overview of various aspects of hazard, exposure and risk assessment of nanomaterials).  Read the report

  • The European Food Safety Authority has today published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed. The guidance is the work of the Authority’s Scientific Committee and is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain. The guidance covers risk assessments for food and feed applications including food additives, enzymes, flavourings, food contact materials, novel foods, feed additives and pesticides. Read the full article

  • Categorising nano-based materials into hazard bands is the core of a new risk assessment technique put forward by French authorities as regulatory bodies continue to explore ways to manage possible threats from the ground-breaking technology. Read the full article

  • The Nanodermatology Society ("NDA" or "the society"), an organization of doctors, scientists, and researchers, was founded with the mission to "promote a greater understanding of the scientific and medical aspects of nanotechnology in skin health and disease." The society recently addressed concerns about the use of nano materials to formulate nanoparticulate titanium dioxide and zinc for use in sunscreen. These ingredients are already common ingredients in sunscreens in their traditional forms. Upon a rigorous review of scientific literature and the latest safety data, the NDS reported in a position statement that the use of these nano materials in sunscreen was safe. The statement noted that "[s]tudies of newer sunscreens [formulated with nanoparticles] show that they are either coated to minimize reactivity, clump in aggregates, or do not penetrate the skin." Other organizations have claimed that nano-based sunscreens are unsafe. NDS hopes that its position statement "[a]s the first of its kind to be released by a scientific society" will encourage more research in the nanotechnology arena. Full Article

  • The EPA has issued a new multi-walled carbon nanotube significant new use rule in the federal register. It applies only to the specific carbon nanotubes that were the subject of PMN P-08-199, and binds anyone who intends to manufacture, import, or process the specific chemical substance. It is largely consistent with past SNURs and Consent Orders for other CNTs. For those wondering, "processors" and "processing" is broadly defined under TSCA. It has been used in the past to include repackaging for commercial purposes, using the material in the manufacturing of new mixtures, and/or the production of articles using the substance. Full article

  • The Program on Reproductive Health and the Environment (PRHE) at the University of California, San Francisco (UCSF) is part of the Department of Obstetrics, Gynecology & Reproductive Services located in UCSF’s School of Medicine. PRHE just published its "Recommendations for Addressing Potential Health Risks from Nanomaterials in California” which was commissioned by California's Office of Environmental Health Hazard Assessment (OEHA). The document is designed to provide the State with an overview of nanotechnology materials and their potential exposures and human health risks, and proposes a selection of policy options for addressing potential hazards and risks from nanotechnology. Full article

  • The UK Food Standards Agency (FSA) has published a report of consumers' views on the use of nanotechnology in food and food packaging. The focus group research, which asked participants about their views on nanotechnology in late 2010 and early 2011, was carried out as part of the FSA's programme of work on nanotechnology.

  • In its opinion on toxicity aspects of nano silver, the Federal Institute for Risk Assessment (BfR) had recommended to waive the use of nano silver in foods and articles of daily use until the data situation allows for a final assessment of the health risks. Mainly industry objected to this assessment by BfR that enough data were available for the evaluation of the health risks of nano silver in consumer products and foods. For that reason BfR had invited experts from research and science as well as representatives of associations and industry to a workshop in order to discuss existing risks and possible options for a comprehensive consumer protection. "The discussion confirmed the words of caution of BfR", said BfR President Professor Dr. Dr. Andreas Hensel, "because the situation continues to be characterised by the fact that not enough secured scientific findings about the specific effects of nano-sized silver particles are available."

  • Although more research is needed to solidify the environmental and occupational risks, the Nanodermatology Society believes that nano-based sunscreens do not pose serious health risks to consumers and agrees with regulatory agencies like the Environmental Working Group, which states: “Zinc and titanium-based formulations are among the safest, most effective, sunscreens on the market”. Read the 2011 Nanodermatology Society Position Statement on Sunscreens.

  • Scientists from the Institute for Health and Consumer Protection (IHCP) of the European Commission's Joint Research Centre (JRC) performed basic risk assessments for four types of nanomaterials: fullerenes, carbon nanotubes, nano-silver and metal-oxides (nano-titanium dioxide and nano-zinc oxide) following the methodology described in the REACH guidance.

  • Engineered nanomaterials present regulators with a conundrum – there is a gut feeling that these materials present a new regulatory challenge, yet the nature and resolution of this challenge remains elusive. But as the debate over the regulation of nanomaterials continues, there are worrying signs that discussions are being driven less by the science of how these materials might cause harm, and more by the politics of confusion and uncertainty. Read the entire article by Andrew Maynard on the Risk Science Blog.

  • The paper examines the progress made in nanotechnology development since 2000, achievements at ten years, and opportunities in research, education, innovation and societal outcomes by 2020 worldwide.

  • The NanoSafety Consortium for Carbon just submitted a proposed toxicity testing agreement to EPA under Section 4 of the Toxic Substances Control Act covering a range of nanoscale materials including multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene. For additional information click here.

  • Workers in all countries face new risks from manufacturing applications of rapidly advancing new technologies based on nanometer-scale atomic structures known as nanomaterials. For additional information click here.

  • A new study finds that the general public thinks getting a suntan poses a greater public health risk than nanotechnology or other nanoparticle applications. The study, from North Carolina State University, compared survey respondents’ perceived risk of nanoparticles with 23 other public-health risks. For additional information click here.

  • In an announcement by Porter Wright earlier today, the NanoSafety Consortium for Carbon just submitted a proposed toxicity testing agreement to EPA under Section 4 of the Toxic Substances Control Act covering a range of nanoscale materials including multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene.

  • Queen’s researchers have discovered that nanoparticles, which are now present in everything from socks to salad dressing and suntan lotion, may have irreparably damaging effects on soil systems and the environment.

  • The European Commission's hesitance to define nanotechnology underscores diverging opinions among stakeholders and is causing uncertainty in the sector, it emerged this week. Read more about the difficulty in establishing regulatory definitions here.

  • California's Green Ribbon Science Panel is reconvening to see what can be done to revive implementation of the Green Chemistry Initiative.

  • Following a request from the European Commission the Scientific Committee was asked to deliver guidance on risk assessment concerning potential risks arising from applications of nanoscience and nanotechnologies to food, feed and pesticides.

     

    Guidance on risk assessment concerning potential risks arising from applications of nanoscience and nanotechnologies to food and feed

  • ISO 10808:2010 specifies requirements for, and gives guidance on, the characterization of airborne nanoparticles in inhalation exposure chambers for the purpose of inhalation toxicity studies in terms of particle mass, size distribution, number concentration and composition.

     

    Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing

  • The U.S. Environmental Protection Agency (EPA) has awarded $5.5 million to three consortia to support innovative research on nanotechnology. EPA, in collaboration with the United Kingdom’s Natural Environment Research Council, are leading this scientific research effort to better understand the potential risks to people’s heath and the environment. The scientific information developed from the research can help guide EPA and other agencies in decisions about the safety of new materials and products that are made using nanotechnology.

  • The National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), will hold a workshop on March 10-11, 2011, to provide an open forum and engage in an active scientific discussion about environmental health and safety questions for nanomaterials and nanotechnology-enabled products, to encourage joint US-EU programs of work that would leverage resources, and to establish communities of research practice, including identification of key points of contact/interest groups/themes between key US and EU researchers for near-term and future collaborations.

     

    Announcement

     

    Workshop Agenda

  • Nanotechnology presents the insurance and risk management industries with significant challenges and opportunities. Read more>>>

  • Despite rumors to the effect that nanomaterials will be exempt under proposed Green Chemistry regulations, nanomaterials will still be regulated as any other chemical substance.

     

    The original draft regulations from the Department of Toxic Substances Control (DTSC) would have created a definition of nanomaterials that engulfed virtually every bulk powder in existence. DTSC officials quickly realized that calling any substance as large as 1,000 nanometers (1 micron) a nanomaterial would create an incredible burden by classifying all of those substances as ‘chemicals of concern’. In addition, the agency attempted to include a term ‘nanoscale phenomena’ to capture any substance, regardless of size, that exhibits properties different at the nanoscale from its bulk counterpart. Unfortunately, the agency was unable to craft a definition of nanomaterials that would allow a regulatory framework to appropriately identify intentionally manufactured nanomaterials in a way that differentiates them from bulk materials with a measurable nanoscale component.

     

    At the same time, the Office of Environmental Health Hazard Assessment (OEHHA) attempted creation of a new nanomaterial hazard trait which essentially would have declared all nanomaterials to be hazardous. The size of a nanomaterial, correctly identified as being in the nanoscale, can be considered a physical trait of a substance but there is no scientific evidence to date indicating that all substances at the nanoscale are hazardous. Hazard traits are properties of chemicals that fall into broad categories of toxicity, adverse environmental effects, physical hazards, or exposure potential characteristics. It’s appropriate to be concerned about specific physical hazards such as explosivity, flammability, oxidization, self-reactivity and radioactivity. The term nanomaterial is not consistent with the others as this term effectively describes a physical property which is not a hazard. Since size can contribute to hazard it may be appropriate to include size as a consideration in evaluating other listed hazards.

     

    In the most recent drafts of proposed regulations from DTSC and OEHHA the nano-specific language was removed clearing the way for nanomaterials to be evaluated and regulated as traditional chemical substances.

  • Always on the edge of occupational safety, the National Institute for Occupational Safety and Health (NIOSH) has established an occupational exposure level for carbon nanotubes.

     

    The Current Intelligence Bulletin, Occupational Exposure to Carbon Nanotubes and Nanofibers, was released solely for peer-review and comment and does not establish any agency determination or policy. Noting that “while there are no scientific reports of ‘adverse health effects in workers producing or using carbon nanotubes…or carbon nanofibers’”, NIOSH also expressed concern over the potential for worker exposure.

     

    NIOSH's carbon nanotube recommended exposure limit (CNT REL) is set at 7 μg/m3 for these preliminary purposes. NIOSH explained the benchmark by indicating the “REL is based on the available subchronic and short-term animal dose-response data of early-stage fibrotic and inflammatory lung re-sponse to CNT exposure. Benchmark dose (BMD) estimates from the animal data (and the 95% lower confidence limit estimates of the BMD) have been extrapolated to humans by accounting for species differences in alveolar lung surface area. Working lifetime exposure concentration have been calculated based on estimates of either the deposited or retained alveolar lung dose of CNT assuming an 8-hour time-weighted average (TWA) work shift exposure during a 40-hour work week, 50 weeks per year, for 45 years.”

  • Hazard communication is important aspect of handling any chemical substance and until now there's been little to guide manufacturers in preparation of safety data sheets for nanomaterials.

     

    The guidelines, Safety data sheet (SDS): Guidelines for synthetic nanomaterials, were published by the Switzerland State Secretary for Economic Affairs (SECO) in December 2010. The guidelines were developed to: demonstrate which information is necessary to ensure the safe handling of nano-objects and products which contain nano-objects; offer assistance on how the relevant information can be identified and in which form in which place they are to be listed in the SDS; and contribute to making employees of companies which produce or process synthetic nano-object aware of the particular properties of these materials.

  • The U.S. Environmental Protection Agency (EPA) is moving forward with a series of new rules and reporting requirements for nanoscale materials.

     

    In late December the EPA published its regulatory agenda with several notices concerning nanoscale materials. In addition, several regulatory officials have been making the rounds with industry groups providing additional information about several actions the agency intends to take in 2011.

     

    The actions range from broad reporting requirements for certain nanoscale materials to Test Rules for specific substances. One of the actions included is a Test Rule under Section 4(a) of TSCA (Toxic Substances Control Act) to require manufacturers and processors of multi-wall carbon nanotubes and certain clays including halloysite, bentonite, and montmorillonite to develop test data for health effects, ecological effects, environmental fate data, and characterization data. That rule is expected to be proposed in April 2011.

     

    Under section 8(a) the EPA is planning a broad reporting requirement for nanomaterials of particular interest for information that would include production volumes, methods of manufacture and processing, exposure release information, and available health and safety data. The Notice of Proposed Rulemaking (NPRM) is expected in February 2011.

     

    Under Section 5, the Agency will issue a Significant New Use Rule (SNUR) to require manufacturers and importers to submit notices at least 90 days before producing any new nanomaterial. The NPRM for the SNUR is expected to be issued in February 2011.

  • The California Department of Toxic Substances Control (DTSC) isn't resting on its laurels when it comes to collecting information on nanoscale materials.

     

    Like last year's data call in for carbon nano tubes, the agency transmitted a letter to 40 companies and academic institutions seeking information on nano silver, nano zero valent iron, nano cerium oxide, nano titanium dioxide, nano zinc oxide, and quantum dots. According to the letter sent by Jeffrey Wong, DTSC Chief Scientist, the agency is “specifically interested in information related to analytical test methods for these chemicals in environmental matrices, including water, air, soil, sediment, sludge, and chemical waste.’

     

    Recipients of the letter are required to provide information in writing to DTSC no later than Wednesday, December 21, 2011.

  • Citing the complexity and demands of AB 1879, the California Environmental Protection Agency is asking the Department of Toxic Substances Control (DTSC) to take a second look at the proposed regulations.

     

    Linda Adams, Secretary for Environmental Protection, transmitted a letter to Assembly Member Mike Feuer informing him of the delay. “I have asked DTSC and its regulation development team to reconvene the Green Ribbon Science Panel early next year to further vet the programmatic issues that have been brought to our attention via the public comment process. This additional time and expertise will help ensure that the vision behind this component of the Green Chemistry Initiative and implementing statute AB 1879, is fully realized” said Ms. Adams.

     

    Ms. Adams indicated that a wide range of stakeholders, including those from industry, environmental groups, scientists, and legislative leaders, “have raised substantive and valid concerns about the most recent draft of the regulations.” The regulations were roundly criticized by industry for a proposed definition of nanomaterials and the establishment of a nanomaterial hazard trait.

     

    The Green Ribbon Science Panel is made up of experts who provide advice on scientific matters, chemical policy recommendations and implementation strategies. Meetings of the Panel are scheduled as needed but generally meet at least two times each year. No indication was given for when the Panel will convene.

  • The Environmental Protection Agency (EPA) Office of Pesticide Programs has another petition to investigate a nanoscale pesticide.

     

    The International Center for Technology Assessment (ICTA) petitioned the EPA to examine three registration applications submitted by Osmose, Inc. for micronized copper carbonate. Micronized materials are often below 1 micron (1,000 nm) and can be smaller than 100 nm which would be considered nanoscale.

     

    The petition by ICTA is the second involving nanoscale pesticides. The first petition on nanosilver in 2008 led to formation of an advisory panel and a public meeting on safety issues related to nanosilver but the EPA has yet to take any action on the petition. ICTA cited studies which indicate that nanoscale copper may be more toxic than its bulk counterpart and the organization is asking the EPA to review all other forms of nanoscale copper in addition to those used by Osmose.

     

    In the meantime, however, the EPA has taken a position that all nanoscale materials in pesticides are considered to be ‘new’ and must undergo a full review even if they have been previously approved. The Office of Management and Budget is still considered the Agency’s revised guidance on pesticide products containing nanoscale materials but has not yet completed its assessment of the revised policy.

  • A new report by the Project on Emerging Nanotechnologies (PEN) categorizes the various nanotechnology voluntary programs and analyzes three different types for their role in oversight.

     

    The report, Voluntary Initiatives, Regulation, and Nanotechnology Oversight: Charting a Path, examines voluntary initiatives which represent three specific types of programs; 1) Government agencies sponsor an initiative and invite others to participate; 2) Business firms organize to achieve an environmental goal or to improve their practices and performance; and 3) Business firms create partnerships with non-government organizations. The specific initiatives identified to represent these types of programs include EDF and DuPont’s Nano Risk Framework, the Environmental Protection Agency’s Nanoscale Materials Stewardship Program, and the Responsible Nano Code, a multi-party collaboration.

  • The definition of nanomaterial has been a hot topic globally and at least one European scientific committee thinks the current definition is too restrictive on size when evaluating the safety of nanomaterials.

     

    The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) was asked to provide an opinion on “the essential scientific elements of an overarching working definition for the term ‘nanomaterial’ for regulatory purposes.” In the recently released final opinion, SCENIHR rejected the commonly-accepted nanomaterial definition of 1 to 100 nm indicating that “There is no scientific justification for a single upper and lower size limit…that can be applied to adequately define all nanomaterials; There is scientific evidence that no single methodology (or group of tests) can be applied to all nanomaterials; and Size is universally applicable to define all nanomaterials and is the most suitable measurand [sic].” The recommendations went on to indicate that “an understanding of the size distribution of a nanomaterial is essential and the number size distribution is the most relevant consideration.”

     

    The opinion recommends a tiered regulatory structure which considers all materials as large as 1,000 nm and suggests consideration of other factors such as size distribution (Using the number size distribution, materials might be defined as being a nanomaterial when more than 0.15% of the material has a size below 100 nm). The opinion also acknowledges the challenge of such a regulatory definition for the some industries and it suggests that “appropriate adaptations might be necessary within a regulatory context dealing with areas such as food/feed and pharmaceuticals.”

  • An interesting change has taken place in Australia. If we are to take the information at face value, it would appear that more nanomaterials were produced in the country in 2006 than in 2008.

     

    In 2006 the National Industrial Notification and Assessment Scheme (NICNAS) asked for a voluntary submission of information from nanomaterial producers on the types of nanomaterials produced, their volumes and their uses. Two years later a second call for information was issued to assess changes in the original submitted data and to determine the extent of health and safety data held by nanomaterial producers.

     

    In the 2006 effort 22 companies reported on 21 different types of nanomaterials while the 2008 call for information resulted in only 7 responses on 6 nanomaterials. All six of the reported nanomaterials were used in commercial applications that have a bulk conventional form. Despite acknowledging limitations to the latest call for information, NICNAS indicates the call-in is still useful in identifying nanomaterials of interest for further scientific assessment.

     

    Read the NICNAS Information Sheet for details.

  • The National Institute for Occupational Safety and Health (NIOSH) has released a Current Intelligence Bulletin (CIB) regarding the occupational safety of carbon nanotubes (CNTs) with sound advice for employers working with them.

     

    The CIB, Occupational Exposure to Carbon Nanotubes and Nanofibers, recommends minimizing exposures until additional safety data can be developed. The draft document summarizes the adverse respiratory health effects that have been observed in laboratory animal studies with single-walled carbon nanotubes, multi-walled carbon nanotubes and nanofibers and provides recommendations for the safe handling of these materials.

     

    NIOSH will hold a public meeting on February 3, 2011 in Cincinnati, Ohio to discuss and obtain comments on the draft document.

  • In a continuing effort to get stakeholder input on an environmental, health and safety (EHS) research strategy, the National Nanotechnology Initiative (NNI) has made its latest draft strategy available for public comment.

     

    The draft NNI EHS research strategy “includes a scientific framework that incorporates the research needed to assess the environmental, health and safety of nanomaterials” according to the portal web site. Developed with input from stakeholders through a series of public meetings, additional comments may be provided through January 6, 2011.

     

    The current draft replaces the NNI EHS Strategy of February 2008. Both documents focus on five key elements that shape EHS research: (1) Nanomaterial Measurement Infrastructure; (2) Human Exposure Assessment; (3) Human Health; (4) the Environment; and (5) Risk Assessment and Management Methods. The strategy evaluates the state of the science for each of these topics and includes an analysis of the FY 2009 Federal EHS research portfolio.

  • In following up on recommendations in its 2007 Nanotechnology White Paper, the Environmental Protection Agency (EPA) has developed some case studies on nanomaterials and will conduct a public meeting to discuss its findings.

    Two recommendations in the paper regarding the risk assessment of nanomaterials include: Developing case studies based on publicly available information on one or several intentionally produced nanomaterials, and from such case studies identify information gaps to help map areas of research that would support the risk assessment process; and to hold a series of workshops involving a substantial number of experts from several disciplines to assist in this process.

    The first case study, Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen, was released in July 2009 and was followed by the Nanomaterial Case Studies Workshop: Developing a Comprehensive Environmental Assessment Research Strategy for Nanoscale Titanium Dioxide on September 29-30, 2009, in Durham, North Carolina. The second case study, Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray, will be the topic of discussion at a Public Information Exchange Meeting on January 4, 2011 at the EPA in Research Triangle Park, North Carolina.

    According to the Federal Register notice, ICF International, a contractor to EPA, will conduct a separate meeting, the ``ICF International Nanomaterial Case Studies Workshop: Developing a Comprehensive Environmental Assessment Research Strategy for Nanoscale Silver,'' on January 4, 2011, in the same location.
  • Benefits and Risk Communication for Nanomaterials Webinar Providing useful information on risks is a challenge under the best of circumstances and with the emergence of nanotechnology it has become even more important as safety information continues to develop.

    Listen to two experts in the Benefits and Risk Communication for Nanomaterials webinar as they discuss business communication strategies that effectively relay important safety information on nanomaterials and nano-enhanced products to downstream users and consumers. Learn about current approaches to risk communications and the importance of consistent and informative communication strategies for tools such as Material Safety Data Sheets and product labeling.
  • David Warheit of the DuPont Haskell Global Centers for Health and Environmental Sciences took aim at some of the most common misconceptions regarding nanoparticle safety in a recently published article.

    Warheit has conducted research on nanoscale titanium dioxide and is a respected scientist on the issue of nanotoxicology. His article, Debunking Some Misconceptions about Nanotoxicology, was recently published online by Nano Letters and he takes dead aim at some of the most common misconceptions.

    Myth 1, Nanoparticles are always more toxic than bulk particles of similar or identical composition, and Myth 2, Particle size and surface area are the critical indices that influence nanoparticle toxicity, are at the top of his list of untruths. Warheit points out that studies have shown size to be important but that other factors like particle surface reactivity may also be an important factor impacting the toxicological characteristics of a nanoparticle. He also suggests that there are a complex set of variables to consider including routes and degrees of exposure, particle-cellular interactions, biokinetics and other interactions to consider.

    Warheit reviewed research papers on these two myths and three others and concluded that hazard effects can’t yet be modeled with such a small database to work with and that more research is needed.

    The other three myths he identified include: All forms of nanoscale titanium dioxide particles have similar toxicity profiles; No current methodologies are available for the responsible development of nanoscale materials; and Pulmonary hazard assessments for nanoparticles can be accurately evaluated using in vitro or in silico methodologies.
  • Not all Non-Governmental Organizations (NGOs) are alike even when they share a common interest. In this case the issue is the regulation of nanotechnology and three well-known activist groups are taking very different paths to satisfy their constituencies.

    In Nanotechnology Regulation: Policies Proposed by Three Organizations for the Reform of the Toxic Substances Control Act, the Chemical Heritage Foundation report looks at the approaches taken by Friends of the Earth, EDF and the Project on Emerging Nanotechnologies. Identified as “interest organizations,” the organizations each have different audiences, mission and style of advocacy.

    For the analysis of the organizations and their approaches to nanotechnology regulation click here.
  • Perhaps the most pressing question for regulators is the definition of nanomaterial. It’s a lot more complicated than some would have you believe.

    The European Commission initiated a consultation to seek input on a definition which contains the 1-100 nm size range but also incorporates surface area and size distribution. The proposal is open for public comment until November 19, 2010. Read the Commission Recommendation for details.
  • The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is introducing new administrative processes for the notification and assessment of industrial nanomaterials that are considered to be New Chemicals.

    Published in the October 5 issue of Chemical Gazette, NICNAS also makes some adjustments to reporting requirements with an updated definition of nanomaterials. The definition closely follows the most commonly accepted aspects of the definition (1-100 nm, intentionally produced, aggregates and agglomerates included) but also includes a “unique properties” aspect as well. For details see the publication here.
  • The anti-nanotechnology movement can be difficult to characterize but a look at the fervor over the prohibition of nanotechnology in organics sheds light on an emotional response to the issue rather than a real dialogue about science.

    For some time the National Organic Standards Board (NOSB) has held back the overwhelming support for a prohibition on nanotechnology in any of its forms for organic food, processing or packaging. In a recent meeting, however, the NOSB accepted several recommendations made by its Materials Committee including yet another definition of nanomaterials, a prohibition of all engineered nanomaterials, and the scheduling of a symposium.

    The symposium is intended to address the adequacy of the definition of nanomaterials, enforceability of the prohibition and the mechanisms to be employed for the prohibition to be put in place. It’s unclear at this point if the workshop will address the potential issue of packaging. As part of their recommendations, the NOSM is supposed to determine if the enforcement of the prohibition on packaging and food contact surfaces is possible, legal and practical.
  • One of the most important areas of nanotechnology for producers and users is risk communication. What risk communication tools are available to assist the people who work in companies that engage in nanotechnology? Learn about the most current approaches to MSDS writing, control banding, and related business communication strategies to assist the occupational safety and health professional. The International Standards Organization and CEN, the European Communities on Standardization, are developing a broad approach to a labeling standard for products containing manufactured nano-objects. The webinar to be held on November 16, 2010, is the latest in the popular Nanotechnology Today series co-sponsored by NanoReg & Keller and Heckman, also is designed to address how to communicate effectively on benefits and risks with the public.
  • Using “nano” in a product name or on product labels has led to confusion for consumers that haven’t been able to distinguish marketing claims from fact.

    ASTM International Committee E56 on Nanotechnology has created a new subcommittee, E56.06 on Nano-Enabled Consumer Products. The scope of E56.06 is to develop scientifically credible standards for identification, evaluation and assessment of engineered nanomaterials in consumer products.

    Members of E56.06 will develop standards for determining the presence of engineered nanomaterials in consumer products and understanding the potential for exposure from the use of these consumer products. Initial efforts of this new subcommittee will focus on the identification and evaluation of engineered nanomaterials in consumer products.
  • The Federal Institute for Risk Assessment (BfR) released three documents on the public’s perception of nanotechnology and the possible risks associated with the production and use of nanomaterials.

    The Delphi Study on Nanotechnology - Expert Survey of the Use of Nanomaterials in Food and Consumer Products details a survey of 70 experts from research, industry, public authorities and nongovernmental organizations about the potential risks of nanotechnology for consumers. The feedback from the first round gave the experts an opportunity to compare their personal impressions with the range of opinions held by the participants. The project identified nanomaterials that are already being or could potentially be used, and attributed them to concrete applications. Based on the knowledge available on exposure and hazards, the applications were then classified according to the level of probable risk and strategies for risk reduction were developed. At two later expert workshops the results were analyzed and compiled in a risk barometer.

    The Perception of Nanotechnology in Internet-based Discussions - The risks and opportunities of nanotechnology and nanoproducts: results of an online discourse analysis investigates the perception of nanotechnology in Internet-based discussions. The study explored the perceived risks and benefits of nanotechnology in a particular sector of the population which has displayed at least an initial interest in the subject or in actual nano-enhanced products and at the same time is active in Internet forums.

    The study, Risk Perception of Nanotechnology - Analysis of Media Coverage, examines German media coverage of nanotechnology between January 2000 and December 2007 in a total of 1,696 articles published in the national quality newspapers. Despite all the publicity surrounding the potential risks of nanotechnology, media coverage very much focused on the potential benefits of the technology.
  • To maintain the principles of organic food production, the National Organic Standards Board (NOSB) is once again considering a proposal to prohibit the use of nanomaterials in packaging, processing and production of organic food.

    There are many within the organic community that sees nanotechnology as a deadly evil that must be rejected both in principle and practice. That attitude has led the NOSB Materials Committee to make recommendations for a new definition of nanoscale and an accompanying prohibition of nanoscale materials by identifying them all as synthetic substances.

    The recommendations also include a proposal to conduct a workshop to further discuss the issue and several trade groups have voiced their support for the proposal. The SOCMA Nanotechnology Coalition, Institute for Food Technologists and NanoBusiness Alliance all submitted comments in support of workshop and recommended that it be held prior to making a final determination on the issue.

    The comments were submitted in response to a Federal Register notice announcing a meeting of the NOSB October 25th through the 28th in Madison, Wisconsin.
  • The California Department of Toxic Substances Control (DTSC) and the U.S. Environmental Protection Agency (EPA) Headquarters are drafting a Memorandum of Understanding (MOU) to facilitate information exchange, collaboration and outline a working partnership between the agencies on emerging chemicals, green chemistry and materials management. U.S. EPA and DTSC will continue the specific focus already underway on nanomaterials collaboration.

    Under the new MOU, DTSC and U.S. EPA will: Establish chemical specific teams for priority chemicals of mutual interest with teams developing specific goals, points of coordination and focus areas; Share information on analytical methods, fate and transport, bioconcentration, toxicity, exposure, risk assessment and similar topics relative to emerging chemicals; Share literature reviews, databases; Collaborate on identifying and prioritizing information and data gaps; Keep each other informed on workshops, symposia, web events, etc.; Share value-chain information (to the extent allowed by law) on producers, importers, production volumes, applications, intermediates, products; Explore ways to exchange information while protecting confidential business information; and Collaborate on research needs and funding.
  • In a continuing effort by California regulatory agencies to implement AB 289, the California Department of Toxic Substances Control (DTSC) recently released the Green Chemistry Proposed Regulation for Safer Consumer Products.

    The release of the proposed regulations follows a two-year dialogue with stakeholders. After issuing the last draft regulation on June 23, 2010, DTSC received 762 pages of comments from more than 90 stakeholders, legislators and the public.

    Much of the dialogue involving industry stakeholders revolves around the definition of nanomaterials which was initially proposed for all materials in the 1 nm to 1,000 nm range. The revised proposal reflects a shift to the more commonly acted definition of 1 nm to 100 nm but now includes a provision that allows for additional evaluations if the substance exhibits “nanoscale phenomena.” This approach is fairly open-ended and regulatory officials could determine that just about any effect is such a nanoscale phenomena.

    Given the lack of sufficient science to be allow for identification of specific nanoscale properties that impact the safety of a nanomaterial, stakeholders continue to develop a workable definition of nanomaterials that will be regulated under the Green Chemistry Initiative.

    The other area of concern for producers and users of nanoscale materials is the proposed prohibition for a de minimis exemption for nanomaterials. While all other chemical substances may be considered for an exemption if it exists in a consumer product below 0.1% by weight, the current proposal eliminates the possibility of any kind regardless of the amount.

    Comments of the proposed regulations must be submitted by November 1, 2010.
  • With budget issues gripping the entire State of California, the Department of Toxic Substances Control (DTSC) was forced to postpone a public workshop on nanomaterials but the agency is now able to move forward.

    The workshop will address three main issues: results of the state's carbon nanotube information call-in; future data call-in requests for additional nanomaterials; and federal efforts related to carbon nanotubes for nanomaterials. The original data call-in took place in January 2009 with over two dozen responses which provided some information but apparently not enough for DTSC staff as it is clear the agency intends to pursue legal action unless it gets what it needs.

    The Public Workshop on State and Federal Nanomaterial Activities is now scheduled for Wednesday, September 22, 2010, at the U.S. EPA Region 9 Office in San Francisco, CA.
  • In a never-ending quest for the perfect solution to the challenges posed by nanotechnology, the Food and Drug Administration (FDA) is holding yet another public workshop on the issue.

    For several years now the FDA has periodically poked its head up out of the sand and held a public meeting/workshop to gather information on nanotechnology and its impact on the medical community. This time, the upcoming event, Public Workshop - Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations, is to “obtain information on the safety and effectiveness of medical devices utilizing nanotechnology.”

    The agency has held a couple of public meetings largely in response to information-gathering activities of an internal task force on nanotechnology. The FDA held an initial public meeting in 2006 to "help further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products." The most recent meeting was held in 2008 and was roundly criticized by many for taking so long after the group developed the Nanotechnology Task Force Report which was released in July 2007. The report provided initial findings and recommendations including; a synopsis of the state of the science for biological interactions of nanoscale materials; analysis and recommendations for science issues; and analysis and recommendations for regulatory policy issues.

    Keeping with a cycle of public meetings every two years, the workshop is scheduled for September 23, 2010 at the Hilton Washington DC/North Gaithersburg in Gaithersburg, MD. The FDA would like public input on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics.

    Many in the nanotechnology community have privately questioned why the FDA is taking so long to reach any kind of conclusions with regard to nanotechnology. The FDA approach may be deliberative and the questions to be answered may be difficult, but the lack of transparency is troubling to many.
  • So many people have discovered this timely and informative series of webinars co-sponsored by NanoReg & Keller and Heckman LLP! The next webinar, Environmental Applications of Nanotechnology: Going Green, is right on target in today's fast-developing nanomaterial marketplace that is being eyed as a key element in the going green economy. The concept of Green Nano is the ability to design industrial processes and everyday products with the protection of human health and the environment in the forefront of the design phase.

    Join two of the leading experts in the area of Green Nano, Dr. Bettye L. (Smith) Maddux, Assistant Director of the Safer Nanomaterials and Nanomanufacturing Initiative (SNNI) and Dr. Olga Koper, Chief Technology Officer of NanoScale Corporation as they discuss the development of products that have environmental applications. The webinar will address how to design "green" products and showcase technologies that show promise for environmentally beneficial applications, such as environmental cleanup, water purification, and energy efficiency. Using any computer with an internet connection you can participate in the latest installment of the popular Nanotechnology Today Webinar Series on October 6, 2010.
  • Initial forays into the regulation of nanomaterials often take the form of establishing an inventory of some kind and requiring labeling regardless of the presence of any known hazards and a European government official has suggested implementation of both options.

    Speaking at the opening of a workshop on the traceability of nanomaterials, Paul Magnette, Belgian minister in charge of consumer protection and environment made the proposal. "Nanomaterials are increasingly present in consumer products and everyday items we use, and yet we don't know a lot about them."

    In addressing the “no data, no market” approach typically envisioned for the REACH process, Magnette expressed concern that it would create de facto moratorium on nanomaterials which would be too restrictive. He also indicated that industry’s persistence in only touting the benefits of nanotechnology without address possible risks “biases customer information.”

    The European Commission conducted an initial regulatory review of nanomaterials in 2008 and a second review is currently underway. The review will entail all aspects related to existing environmental legislation on water, waste and air in addition to occupational safety. The results of the assessment will be included in the 2012 REACH review.

    In his presentation, Magnette also proposed implementation of a mandatory labeling requirement for nanomaterials in consumer products but did not provide any information on the specifics of the proposed requirements or a timeframe for implementation.
  • The Massachusetts Office of Technical Assistance and Technology (OTA) has released a guidance document which includes recommendations intended to enhance the safety of nanotechnology.

    The document, Nanotechnology - Considerations for Safe Development, utilizes existing sources of information and subject matter experts to summarize the best practices for the production, handling and use of nanomaterials.

    Key recommendations in the document include: Development of a risk reduction plan for manufacturing facilities; Establishment of a program for worker safety; Assessment of processes to determine if engineered nanoparticles can be substituted for other substances; Containment to prevent environmental releases and occupational exposure; and the use of appropriate personal protective equipment when needed.

    Recommendations are also provided on the handling of releases and shipping of waste material. The document also recommends implementation of the British Standards Institute’s labeling guidance to provide labeling on the product itself or its packaging, when “any different handling, maintenance, cleaning, storage or disposal of the product is advised as a consequence of nanoparticle content.”

    According to the mission statement, OTA is “the Commonwealth's center for technical information and assistance, helps businesses and other organizations improve their environmental performance as well as conserve energy, water and other resources. OTA promotes the implementation of management strategies, systems and technologies that enable businesses to enhance their competitiveness as they reduce use of toxic chemicals, prevent pollution, conserve resources, and ensure worker health and safety.”
  • The federal regulation of nanomaterials continues to move forward with the issuance of Significant New Use Rules (SNURs) for two chemical substances which were the subject of Premanufacture Notices (PMNs).

    The Federal Register Notice finalizes SNURs for two PMNs which had previously been withdrawn when the Environmental Protection Agency (EPA) received notices of intent to submit adverse comments on these SNURs. The specific substances are described as multi-walled carbon nanotubes (PMN P-08-177) and single-walled carbon nanotubes (PMN P-08-328).

    The Final Rule: Retains the proposed workplace protection, specific use, aggregate manufacturing and importation volume limitations, and release to water provisions (essentially banning releases to water); Provides clarification on the exemptions from applicability of the Significant New Use Rule; and Provides additional human health and environmental summary information to support EPA's findings under Sec. 721.170(b)(4)(ii) and EPA's findings in the proposed rule.

    In providing a rationale for the applicability of the SNURs, EPA clarified the regulatory text for those substances which are exempt from the provisions of the SNURs. These exemptions apply to quantities of the PMN substances: After they have been completely reacted (cured); Incorporated or embedded into a polymer matrix that itself has been reacted (cured); or Embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing.

    The final rule goes into effect on October 18, 2010.
  • The regulatory status of nanomaterials in the proposed regulations is now more in line with other jurisdictions but should nanomaterials be denied the possibility of a de minimis exemption?

    After release of the California Department of Toxic Substances Control (DTSC) Draft Regulation for Safer Consumer Products on June 23, 2010, various stakeholders commented on a new definition of nanomaterials. In the draft document the definition, "nanoscale” means one or more dimensions of the order of 1,000 nanometers or less with "nanomaterial" meaning any form of an engineered chemical, substance or material that is composed of a discrete nanostructure, which has one or more dimensions at the nanoscale.

    In the proposed regulations “nanomaterial” means any form of an intentionally engineered chemical, substance or material that is intended to be composed of a discrete nanostructure that meets either of the following criteria: 1. At least one spatial dimension of the nanostructure is at the nanoscale; or 2. The nanostructure is larger than nanoscale in any spatial dimension, but is 1,000 nanometers or less in at least one spatial dimension, and the nanostructure exhibits one or more nanoscale phenomena. This approach allows DTSC to more appropriately define nanomaterials in a manner consistent with other regulatory authorities and still capture those substances with unique properties even if the size of the substance exceeds 100 nm.

    One area of concern remains for nanomaterial producers and users with the de minimis exemption. The proposed regulation specifies that “In no case, shall the de minimis exemption be allowed for chemicals, materials, or substances manufactured or engineered at the nanoscale, or which contain nanostructures, or are considered to be a nanomaterial.” Nanomaterials are the only substances denied this exemption under the proposed regulations.

    A written comment period has been established commencing on September 17, 2010, and closing on November 1, 2010. DTSC will hold a public hearing on the proposed regulations at 1:00 p.m. on November 1, 2010 in the Byron Sher Auditorium, in Sacramento, CA.
  • What is a hazard trait? Science experts would generally agree with many of the most common physical and chemical traits attributed to hazardous substances such as flammability and explosivity but should nanomaterials automatically be considered hazardous?

    The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed to include a nanomaterial ‘trait’ as part of its Pre-Regulatory Draft, Green Chemistry: Hazard Traits, Endpoints, and Other Relevant Data. The document seeks to identify important science-based hazard characteristics which will be used to evaluate chemical substances under the state’s Green Chemistry Program. The draft identifies hazard traits, which, for the most part, are well-established factors that are broadly accepted within the scientific community.

    In this proposal a new hazard trait called ‘nanomaterial’ would be created essentially making all such substances hazardous. Unfortunately, there is no scientific evidence to date indicating that all substances at the nanoscale are always hazardous. While materials may have unique properties when produced at the nanoscale there is no evidence to indicate that such unique properties always present any additional hazards beyond those seen in their bulk counterparts.

    Oddly, there was no need for OEHHA to single out nanomaterials in such an unusual way. Nanomaterials are chemical substances and there are multiple points within the pre-regulatory draft document which address these substances in a way which allows the agency to fully evaluate the safety of individual chemical substances without inappropriately considering all nanomaterials to be hazardous.

    The document was released for discussion only and the time would be appropriate for all the stakeholders to be brought into the discussions. That includes harmonization of the Green Chemistry Program by having OEHHA and the Department of Toxic Substances Control coordinate the regulation of nanotechnology so the State of California can speak as a single voice and the regulated community will have a better understanding of its obligations.
  • The second webinar of the popular Nanotechnology Today 2010 Webinar Series, Manufactured Nanomaterials: Europe and North America Forecast, will address how new chemical reform legislation currently before the U.S. Congress impacts nanotechnology. In addition, the webinar will discuss how Europe is already addressing nanoscale commercial products through REACH and how Health Canada and the European Commission are seeking to define the term "nanomaterial."

    The webinar series addresses important regulatory issues and challenges associated with the safe development of nano-enhanced products featuring respected nanotechnology experts who work at the forefront of nanotechnology applications and implications.

    Two experts will make presentations in this webinar on September 1, 2010 which is sponsored by NanoReg & Keller and Heckman LLP. Martha Marrapese, a Keller and Heckman Partner, focuses on emerging technologies in the industrial chemicals, antimicrobial pesticides, and food packaging sectors. In addition to an expertise in the Toxic Substances Control Act (TSCA) and its counterparts in Canada, the European Union, and China, she currently serves as a U.S. delegate to the TC-229 150 Committee on Nanotechnologies and chairs working Group 1, Nomenclature and Terminology for the U.S. Technical Advisory Group to TC-229.

    Dr. Steffi Friedrichs, Director-General of the Nanotechnologies Industry Association (NIA), has represented the nanotechnology industries through provision of expert advice and evidence to numerous national and international expert committees and regulatory organizations on a wide range of topics including regulatory and EHS issues, environmental issues, societal benefits of nanotechnologies, education and commercialization/business issues related to the advancement of nanotechnologies to general policy considerations for emerging technologies.
  • One of the most cited numbers in nanotechnology discussions is the number of nanotechnology-based consumer products on the Project on Emerging Nanotechnologies (PEN) Consumer Products Inventory (CPI). As the number of products in the inventory increased, discussions over the concerns of consumer exposure to nanomaterials ratcheted up as well but a new study exposes serious deficiencies in the inventory.

    David Berube, Professor in Communication and Director of the Public Communication of Science and Technology (PCOST) Project at North Carolina State University, led a team that examined a sample of the inventory in an effort to validate the accuracy of the CPI. The journal article, Project on Emerging Nanotechnologies – Consumer Product Inventory Evaluated, was published in the current issue of Nanotechnology Law & Business.

    The CPI has often been taken to task for publicizing a large number of products while downplaying the lack of verification of products before incorporating them into the database. While the web site has a disclaimer, admitting that the inventory is “not comprehensive,” the organization repeatedly issued press releases citing ever-increasing numbers claiming the “inventory gives the public the best available look at the 1,000+ manufacturer-identified nanotechnology-based consumer products currently on the market.”

    Authors of the evaluation of the CPI note that the website ‘renounces’ responsibility for information in the inventory and goes on to chide PEN for making no attempt to validate any information by using only information that can be found on the internet. Inclusion in the product inventory is determining by three criteria: 1) They can be readily purchased by consumers; 2) They are identified as nano-based by the manufacturer or another source; and 3) The nano-based claims for the product appear reasonable.

    Using the current inventory, researchers identified four search terms to evaluate a subset of products: carbon, gold, silver, and iron. The team reviewed 82 products that referenced carbon, 27 products with gold, 258 products using silver and 24 products referencing iron.

    Several conclusions by the author reflect serious concerns over the validity of the database. Do the products listed actually contain nanomaterials or are they just marketing claims? Are the products currently offered for sale? If not, will they be removed from the inventory?

    Those that cite the numbers publicized by PEN were also chided for failing to exercise due care in validating the number of products in the database. “The primary implications of our findings are associated with levels of care taken by those who cite the CPI. It is very important to note that while we suspect the reliability and validity of the products on the CPI, we are not concluding the number of products employing nanotechnology to which consumers are exposed as insignificant. However, referencing the CPI for academic or professional purposes may delegitimize the credibility of both the referrer and the claims of the referrer.”
  • There are many ways to regulate chemical substances and mandating the collection of information seems innocuous but one has to wonder what the information will be used for.

    On December 3, 2007 Wisconsin Representative Terese Berceau wrote a letter to the Departments of Natural Resources, Health and Family Services and Agriculture, Trade and Consumer Protection calling for the establishment of a policy to require private companies that manufacture nanoparticles to disclose information about the types of particles they're making. The policy never materialized so the legislature formed a special committee to study the regulation of nanomaterials from an EHS perspective.

    The Committee, chaired by Rep. Chuck Benedict, is “directed to examine the human health and environmental concerns related to the manufacture, use, and disposal of nanomaterials and develop legislation to address these concerns. In particular, the Special Committee shall consider the establishment of methods to monitor nanomaterials by use of a nanotechnology registry system or the imposition of other disclosure requirements.”

    In addition, the Committee “shall also develop strategies to facilitate the development of nanotechnology to create and retain jobs in Wisconsin, including ways in which government can help nanotechnology researchers, small firms, and start-ups address potential risks and meet regulatory requirements.”

    Given the previous attempts to create a nanomaterial registry, legislation to come out of the Committee efforts will probably include: collection of information on the type, form, and amount of nanoscale materials being produced by reporting entities; evaluation of the most current environmental monitoring methods for such materials; identification of the toxicological properties of such materials; determination of the best methodology for monitoring, containing, handling, transporting, and disposing of such materials in/from the workplace; and submission of information regarding how the entities intend to prevent unintended releases and mitigate the effects of any release.
  • In an unusually busy year of chemical policy legislation, Toxic Substances Control Act (TSCA) reform got some political company with the introduction of the Safe Cosmetics Act of 2010.

    Introduced by U.S. House of Representatives’ Jan Schakowsky (D-IL), Ed Markey (D-MA) and Tammy Baldwin (D-WI) as HR 5786, the bill would have a far-reaching effect on the cosmetics industry. An underlying feature of the legislation is an attempt to update the existing law passed in 1938 and require greater disclosure on the safety of chemicals used in cosmetics with a focus on fragrances.

    “Harmful chemicals have no place in the products we put on our bodies or on our children’s bodies,” said Rep. Schakowsky. “Our cosmetics laws are woefully out of date -- manufacturers aren’t even required to disclose all their ingredients on labels, leaving Americans unknowingly exposed to harmful mystery ingredients. This bill will finally protect those consumers.”

    Several aspects of the bill would enact provisions making the regulation of cosmetic chemicals similar to the regulation of antimicrobials. All cosmetic companies would be required to register with the Food and Drug Administration (FDA) and pay registration fees. The FDA would establish a list of ingredients prohibited from being used in cosmetics and it would require manufacturers to conduct safety assessments and submit information to the FDA.

    The label on each package of cosmetics would be required to list the name of each ingredient, including the components of fragrance. For products that fail to meet the safety standard, HR 5789 would provide the FDA with recall authority, the ability to request a voluntary recall or to order a halt to distribution.

    Companies would have to submit ingredient statements for every product they manufacture to the FDA. The label on each package of cosmetics would be required to list the name of each ingredient, including components of fragrances.

    Like the requirements of TSCA for traditional chemical substances, cosmetic manufacturers, packagers, and distributors would have to submit a report to the FDA on any serious adverse events associated with the use of a cosmetic. Another interesting aspect of the bill for cosmetic companies is that it specifically grants states the right to set more stringent standards.

    After introduction the bill was referred to the Committee on Energy and Commerce and the Committee on Education and Labor.
  • The Environmental Protection Agency (EPA) continues to review its approach to nanomaterial Significant New Use Rules (SNURs) by reopening the comment period for a rule proposed for multi-walled carbon nanotubes (MWCNTs).

    On February 3, 2010, the EPA published a proposed rule for the chemical substance generically identified as multi-walled carbon nanotubes described in premanufacture notice (PMN) P-08-199. The SNUR would “require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of the specific multi-walled carbon nanotubes identified by the notice for any activity designated by this SNUR as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs.”

    In the latest action by the Agency, the comment period has been reopened for 30 days to address public comments and to add information to the docket. In the Federal Register notice the Agency highlighted some specific issues addressed in submissions received during the original comment period.

    One commenter noted that neither the proposed rule nor the docket contained specific carbon nanotube data or data supporting the nature of the dermal concern for carbon nanotubes. That commenter stated it was not possible to assess the Agency's evaluation and determination under Sec. 721.170(b)(3)(ii) based on the current record.

    Another commenter noted that EPA's subsequent reviews and concerns for carbon nanotubes have expanded and that the proposed SNUR should reflect those updated data.

    EPA has added additional explanations and references of its health and environmental concerns for carbon nanotubes to the public docket for consideration. Comments must now be submitted to the docket by August 27, 2010.
  • Building on last year’s popular webinars on the regulation of nanotechnology, Keller and Heckman & NanoReg are pleased to announce Nanotechnology Today 2010, a series of four new webinars designed to address important regulatory issues and the challenges associated with the safe development of nano-enhanced products.

    Nanotechnology Today 2010 will focus on State regulation of nanotechnology in the absence of national regulations, the impact of nanomaterial regulation in Europe and North America, environmental applications of nanotechnology, and benefits and risk communication for nanomaterials. This series features respected nanotechnology experts who work at the forefront of nanotechnology applications and implications.

    The first webinar on July 20, 2010, State Regulation of Nanotechnology: What's Next?, will discuss state initiatives across the U.S. and it will give participants a better understanding of their impact. The featured speaker will be Dr. Jeffrey Wong, Chief Scientist for the California Department of Toxic Substances Control, who will discuss the results of the recent data call-in for carbon nanotubes and plans for future data call-ins. NanoReg's John DiLoreto will address the various initiatives underway at the state level across the United States.

    The webinars will deliver live content via the internet and can be attended from the convenience of an attendee’s home or office where multiple attendees can participate for the cost of a single registration. The series offers small companies the assurance that they can keep abreast of nanotechnology science, policy, the law, and best practices.
  • Despite years of progress toward internationally-accepted definitions of nanotechnology it's clear that much work remains to be done with regulatory officials to define nanotechnology and nanomaterials in their own way.

    In recent days several organizations have released documents indicating definitions of nanotechnology that do not conform to the commonly-accepted definition of equal to or less than 100 nm in at least a single dimension. The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) released a Manual of Policies and Procedures (MAPP) document that uses a working definition of nanomaterials and nanoscale materials as any materials “with at least one dimension smaller than 1,000 nm.”

    The State of California has also decided to use a similar definition in its Green Chemistry Draft Regulation for Safer Consumer Products. For consumers and manufacturers alike, the dizzying array of definitions leads to confusion and concern which can only inhibit the growth of consumer products containing nanomaterials and provide a myriad of regulatory obligations for producers and users.

    In response to a European Parliament resolution in 2009, a new report, Considerations on a Definition of Nanomaterial for Regulatory Purposes, has been released to provide context for the various definitions of nanotechnology, nanomaterials and the term nanoscale. The report provides a comprehensive summary of definitions currently in use in the United States, United Kingdom, Denmark, Canada, Australia, the European Union, the OECD and the International Organisation for Standardisation (ISO).

    Until recently, virtually every jurisdiction used 100 nm is the focal point for determining whether or not a material is in the nanoscale. While there are variations in the language, 100 nm is typically the upper (larger) end of the scale and going down as low as 1 nm although several jurisdictions consider the 1 to 100 nm levels as "approximate" allowing them to take into consideration other factors such as special properties associated with the material. The lone exception to this has been the UK's Environment, Food and Rural Affairs (DEFRA) definition of "two or more dimensions up to 200 nm" but the organization also indicates the definition will be reviewed periodically according to the ongoing work of ISO.

    To complicate matters further the European Commission is contemplating a 500 nm cutoff and the German delegation has initiated the establishment of a registry of nano-enabled products using 500 nm as an ‘initial definition of nanomaterials.’ The French delegation, as part of its public stakeholder dialogues has floated the concept of a 400 nm limit as well.

    While size is certainly one factor in determining what constitutes a nanomaterial several other factors are taken into consideration as well. Nanomaterials often display different chemical, physical, and biological characteristics, and thus behave differently, with respect to materials of a coarser structure, even when the elemental or molecular composition is the same.

    Another important element in the definition is whether or not the material is made intentionally or is naturally occurring. The two most commonly used terms are intentionally "engineered" or "manufactured" to obtain specific physical, chemical, or biological properties. Clearly there are nuances in the use of each of these terms but both reflect intent on the part of the manufacture to create a material of at the nanoscale that is not generally found in nature.

    Industry officials have expressed concern over the lack of commonly-accepted definitions as it becomes increasingly important to understand the regulatory definitions allowing companies to meet its obligations in multiple jurisdictions. A multitude of definitions will generally require manufacturers to meet the most stringent requirements in order to broaden its market to the greatest extent possible. In doing so, broadening of the definition to capture a greater number of materials as 'nanomaterials' will also force producers into more costly and time-consuming safety testing in order to bring products to market.
  • A report from the General Accountability Office (GAO) provides a series of recommendations to the Environment Protection Agency (EPA) on how to regulate nanotechnology but the Agency has been implementing new policies for some time.

    The report Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk, provides a summary of the use of nanomaterials in commerce and examines the EPA's ability to regulate the potential risks associated with nanomaterials. The report suggests that the "EPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the statutes include volume-based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials."

    Within the report a series of recommendations are made to the EPA. The Agency responded to the draft report on May 4, 2010 with a letter acknowledging the challenges in regulating the potential risks of nanoscale materials to human health and the environment and provided a series of responses to the recommendations.

    Recommendations involving the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in which the Agency agreed with the report include: Completion of its plan to issue a Significant New Use Rule (SNUR) for nanomaterials: Modification of FIFRA pesticide registration guidelines requiring applicants to identify nanomaterial ingredients in pesticides; and Completion of its plan to clarify the FIFRA guidelines to make clear that already-registered pesticides that have been reengineered to include nanomaterials need to obtain an amended registration.

    The Toxic Substances Control Act (TSCA) was also the subject of agreeable recommendations to the Agency including: Completion of its plan to use data-gathering under the Toxic Substances Control Act (TSCA) to gather information on nanomaterials including production volumes, methods of manufacture and processing, exposure release, as well as available health and safety studies; Use of information-gathering provisions of the Clean Water Act to collect information about potential discharges containing nanomaterials; and Consideration by the EPA Administrator to revise the inventory update rule so that it will capture information on the production and use of nanomaterials so that the agency will receive periodic updates on this material.

    While many of these recommendations have been released in the form of a formal report by the GAO, it's clear the Agency has been considering many of these changes for quite some time. Several SNURs have already been issued and a presentation by OPP’s Senior Policy Advisor, William Jordan, at a recent Pesticide Program Dialogue Committee meeting highlighted impending changes to FIFRA policies. Several of the policies implemented under TSCA have already been announced in the Federal Register and changes to FIFRA policies are expected to be announced shortly.
  • Faced with growing concern over the scope of the California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) decision to weigh in on how nanotechnology should be regulated, the agency has taken a step back to consider its options for completion of the project.

    Sources familiar with the project indicate the draft report is 'on hold' because OEHHA staff is concerned that so much of the report went beyond the intended scope of the project. Privately, OEHHA staff indicated that the report was the product of the lead researcher who has already left the University of California San Francisco and may not be available to further explain the work or to incorporate comments submitted after release of the original draft report.

    Many within industry continue to be concerned about the report because it contains virtually no input from policy experts. The description of the project indicates the effort was intended to fill data gaps in the risk assessment process for nanomaterials but somehow wandered into the area of government policy. The draft report left many within industry confused since it took minimal information on nanotechnology safety and generated a list of recommendations on regulatory policy for the State of California.

    The Science Advisory Panel for the project consisted of several scientific experts that included no one from the policy community from industry or from the California Department of Toxic Substances Control (DTSC). Those within the nanotechnology industry were caught off guard by the release of the report and provided multiple comments on the need for additional time to evaluate the recommendations and to provide policy expertise for incorporation into the final report.
  • Not only is the State of California embarking on an ambitious plan to regulate product safety throughout the supply chain, it also has redefined nanomaterials in a way that will bring virtually every solid bulk powder into the nanotechnology regulatory framework.

    On June 23, 2010 the California Department of Toxic Substances Control (DTSC) released the Green Chemistry Draft Regulation for Safer Consumer Products. The draft regulation, will apply to all consumer products made available for use in California. Two key aspects of this regulation incorporate Green Chemistry Principles and lifecycle thinking in an effort to "prioritize toxic chemicals and products, require manufacturers to seek safer alternatives to toxic chemicals in their products and create governmental responses for lack of compliance."

    Of particular interest to the nanotechnology community is a new definition being applied under the draft regulation. Within the definition, "nanoscale” means one or more dimensions of the order of 1,000 nanometers or less. "Nanomaterial" means any form of an engineered chemical, substance or material that is composed of a discrete nanostructure, which has one or more dimensions at the nanoscale.

    Virtually any bulk solid material will be considered a nanomaterial within the draft regulations since the bulk distribution curve will show nanoscale-sized material in virtually every case. In addition, there will be no de minimus (0.1%) exemption for chemicals, materials, or substances manufactured or engineered at the nanoscale, which contain nanostructures, or are considered to be a nanomaterial.

    The draft regulation calls for implementation in three phases. The first is the prioritization process in which DTSC will identify and prioritize chemicals of concern and products that contain them. These priority products will be the subject of the second phase – an alternatives assessment, conducted by manufacturers of these products, to identify safer alternatives. In the third phase, DTSC will impose various regulatory response actions to address any remaining concerns raised by the alternatives selected by manufacturers for implementation, and to move manufacturers toward designing safer products.

    The criteria to be used to identify “Chemicals of Concern” are broadly defined which would allow DTSC wide latitude to evaluate and select chemical substances and products. This list will be evaluated and refined to create two product lists. The “Products under Consideration” list will include products that pose public-health and environmental threats because they contain chemicals of concern. Further evaluation will generate a “priority products” list of products that are of the highest priority based on the relative degree of public health and environmental threats posed by the product due to the chemical of concern contained in the product.

    Manufacturers will be required to provide extensive information on products containing chemicals of concern and will be required to perform an alternatives assessment. The alternatives assessment report will include product lifecycle analysis economic impacts and other information as needed. Failure to provide this information could result in a restriction on the sale of products containing chemicals of concern in the State of California.

    Prior to finalizing the two lists, DTSC will make the list available on its website for public review and comment along with all supporting documentation. This may prove troublesome for industry with the draft regulation also restricting the use of confidential business information claims. All information provided under this regulation will be considered public information with very few allowances for claims of confidentiality.

    Comments on the draft regulations may be provided until July 15, 2010. There is another opportunity for comment since the formal Administrative Procedures Act rulemaking process allows for a 45-day public comment period following the July 15th comment deadline.

    In addition to release of the draft regulation DTSC will hold two informal half-day public workshops on July 7th and July 8th. Both workshops will be held at Cal/EPA building at 1001 I St. in Sacramento in the Byron Sher Auditorium.
  • The IFT (Institute of Food Technologists) International Food Nanoscience Conference is a one-day program, held in conjunction with the IFT Annual Meeting & Food Expo, to explore nanotechnology innovations and impacts on the food sector. With the rapid development of nanotechnology applications in other sectors, significant nanotechnology impacts to the food industry are increasingly feasible. Now in its fifth year, the conference has been redesigned to serve the specialized needs of researchers, R&D professionals, and scientists by offering more advanced, in-depth assessment of issues relevant to food science and the food industry.

    The program, Food Nanomaterials: Safety and Regulations, Government Investments, and Industry Needs will highlight the recent advances in safety and toxicological assessment of nanomaterials developed for, or relevant to, food application. The keynote address by Bernadene Magnuson, Ph.D., Senior Scientific and Regulatory Consultant, Cantox Health Sciences International, will be based on a recently completed research report by IFT, in collaboration with the Food and Drug Administration, Grocery Manufacturers Association, North American Branch of the International Life Sciences Institute and Nanotechnology Characterization Laboratory of the National Cancer Institute, through a contract with Cantox Health Sciences International.

    Other important topics to be explored are current regulatory guidelines in the U.S. and the Europe, with discussion on legal implications for the food industry; investment (public and private) in nanotechnology research and development initiatives worldwide; and industry needs for successful application of nanotechnology in food.
  • An earlier study that showed a possible link between carbon nanotubes and mesothelioma caused sensational headlines across the globe became a rallying cry for those concerned about the potential hazards associated with nanomaterials.

    A new study conducted by Swedish and American scientists revealed that carbon nanotubes may be broken into harmless components by an enzyme found in the body. The enzyme, found in white blood cells, can break the material down into water and carbon dioxide.

    The study, Carbon Nanotubes Degraded by Neutrophil Myeloperoxidase Induce Less Pulmonary Inflammation, contradicts a previous study which linked long multi-walled carbon nanotubes to mesothelioma. The previous study exposed the mesothelial lining of the body cavity of mice resulting in inflammation and the formation of lesions known as granulomas. The new study showed that nanotubes can be catalytically degraded over several weeks by horseradish peroxidase and the biodegraded nanotubes did not generate an inflammatory response when aspirated into the lungs of mice.

    "This means that there might be a way to render carbon nanotubes harmless, for example in the event of an accident at a production plant," said Dr Bengt Fadeel, an associate professor at the Swedish medical University Karolinska Institutet. He added, "But the findings are also relevant to the future use of carbon nanotubes for medical purposes."
  • The Organisation for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) continues its international efforts to promote nanotechnology safety by updating its nanomaterial testing guidance document.

    The original document was released in 2009 to “assist sponsors in the development of Dossier Development Plans (DDPs) which describes the testing programme for specified manufactured nanomaterials.” The revised document, Guidance Manual for the Testing of Manufactured Nanomaterials: OECD’s Sponsorship Programme; First Revision, is intended to be a “living” document with periodic updates as new information becomes available.

    In the latest revision, the WPMN developed a Data Sharing Template Format and added it to the guidance document as Annex III. Annex IV has also been added to the document to address Alternative Methods in the Sponsorship Programme.

    The OECD WPMN also released the Preliminary Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials. The OECD Guidelines for the Testing of Chemicals are a collection of the most relevant internationally agreed testing methods used by government, industry, and independent laboratories to assess the safety of chemical products.

    Because specific testing methods for nanomaterials have not yet been fully developed, this work by the WPMN represents initial efforts to identify and resolve issues related to nanomaterial testing. Ultimately, the group will be working toward development of standard tests generating information which can be accepted by regulatory authorities globally.
  • European Members of Parliament (MEPs) added two nanoscale substances to the EU Restriction of Hazardous Substances Directive (RoHS) which could have a significant impact on the marketability of these materials.

    The action taken by Environment Committee called for a ban on nanosilver and long multi-walled carbon nanotubes (MWCNTs) with members indicating that other electrical and electronic material-containing nanomaterials should be labeled and that manufacturers should be obliged to provide safety data to the European Commission. The RoHS applies to goods imported from third countries as well as those produced in the EU.

    Jill Evans (Greens/EFA, UK), the MEP guiding this legislation through Parliament, commented: "I am glad that, despite heavy pressure from the chemical industry, the Environment Committee has today voted for certain problematic substances to be highlighted for further review and a possible ban."

    The Committee adopted amendments adding the nanoscale materials to Annex IV, despite the fact that nanomaterials were not included in earlier proposals. In effect, there would be no threshold, with equipment prohibited from the market if it contained either nanosilver or MWCNTs at “detectable levels.”

    The full Parliament is currently scheduled to vote in July on the Environment Committee recommendations for recasting the RoHS Directive. The Environment Committee will also vote on the related Waste Electrical and Electronic Equipment (WEEE) Directive later this month, with a plenary vote also to follow in July.
  • Yet another new definition of nanomaterials and an unusual use of regulatory authority has the Silver Nanotechnology Working Group (SNWG) concerned that the new policy recently revealed by the Environmental Protection Agency’s (EPA) Pesticide Program Dialogue Committee (PPDC) will threaten not only the nanosilver industry, but all nano-related industries.

    In a letter to Steve Owens, Assistant Administrator of the Office of Chemical Safety and Pollution Prevention, the SWNG expressed concern that the policy will: Institutionalize an arbitrary definition of nanotechnology; Contradict the statutory language and purpose of section 6(a)(2) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA or the Act); Improperly characterize nanosilver as a new pesticide; Stifle innovation without any benefit to human health and/or the environment; and Promote a negative public perception regarding nanotechnology as a whole.

    One concern expressed by the group regarding data collection has been echoed by many producers and users of pesticides and antimicrobials. The agency intends to use FIFRA Section 6(a)(2) to gather safety data on new substances in addition to previously-registered pesticides and antimicrobials. While this mechanism has typically been applied to collecting safety data on materials exhibiting adverse effects, the agency intends to use the same regulatory authority to collect information on the use of nanomaterials in pesticides and antimicrobials regardless of the finding of adverse effects.

    SNWG is asking the Agency EPA to consider its concerns before finalizing its new policy which it readily admits is a “re-interpretation” of previous policy.
  • It’s only seen in a policy manual providing guidance on the gathering of data on drugs containing nanomaterials but it could reveal an important shift of policy by the Food and Drug Administration (FDA).

    The FDA has been slow to engage the public on nanotechnology issues although it has held a few workshops and seminars which revealed a great deal of thinking on the major issues associated with the use of nanomaterials. The FDA formed a Nanotechnology Task Force and issued a report in July 2007 but has released little in the way of the findings. Additional public meetings have been little more than information-gathering opportunities for the Task Force.

    On June 3, 2010, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) released a Manual of Policies and Procedures (MAPP) entitled Reporting Format for Nanotechnology-Related Information in CMC Review. The document itself is intended to provide guidance for reviews of current and future CDER drug application submissions. However, within the definitions, the document reveals a working definition of nanomaterials and nanoscale materials as any materials “with at least one dimension smaller than 1,000 nm.”

    While most standards-setting organizations and regulatory bodies consider nanomaterials to be between 1 and 100 nm this seems to be the first instance of a regulatory body expanding the size of the nanomaterial which would capture a larger universe of substances in its reviews.
  • The era of making confidentiality claims on chemical substance notifications to the Environmental Protection Agency (EPA) for everything from company names to the names of chemical substances is coming to an end.

    For decades industry confidential business information (CBI) submissions to the EPA regarding chemical substance information and safety data have gone unchallenged but a recent Federal Register Notice announces a new policy at the Agency which will effectively limit the practice.

    The Federal Register notice is revealing in that it begins by stating that the EPA will “begin a general practice of reviewing confidentiality claims for chemical identities and health and safety studies, and in data from health and safety studies.” While the agency has had the ability to challenge these claims in the past it generally has not done so.

    The Agency announced possible several changes to its CBI policy at the GlobalChem conference in Baltimore recently and this action would appear to be the first step taken in response to concerns expressed by non-governmental organizations regarding the Agency’s failure to challenge confidentiality claims made by industry.

    Under the new policy, confidentiality claims regarding chemical identities will be rejected when: The claim was submitted as part of a health and safety study, or of data from a health and safety study; It doesn’t explicitly contain process information; or It does not reveal data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture. After review, a determination letter rejecting the confidentiality claim will be transmitted to submitters but no time frame is specified.

    The Agency recently removed over 500 chemical substances from the confidential portion of the Toxic Substances Control Act (TSCA) Inventory when it discovered that information claimed to be confidential on Premanufacture Notice (PMN) submissions was publicly available on company web sites.

    According to the Federal Register Notice, the EPA intends to begin reviewing confidentiality claims for identities of chemical substances in health and safety studies, and data from health and safety studies, in accordance with the new guidance, on August 18, 2010. The Agency is asking for comments prior to that date regarding classes of chemical substances and attributes of chemical identities that do or do not disclose process information in order to better inform the Agency's reviews. Where process information in the chemical identity is unnecessary to characterize the chemical substance or mixture, EPA has indicated it may release a version of the chemical identity with the process information removed. The Agency will begin full reviews of confidentiality claims for both newly submitted and existing claims on August 25, 2010.
  • The Organisation for Economic Co-operation and Development (OECD) Environment Directorate has added to its Series on the Safety of Manufactured Nanomaterials with the recent release of three new documents.

    Document 21, is a Report of the Workshop on Risk Assessment of Manufactured Nanomaterials in a Regulatory Context which summarizes a workshop held in Washington, DC in September 2009. The workshop event was co-hosted by the Business and Industry Advisory Committee (BIAC) and the Society for Risk Analysis (SRA). The main objectives of the workshop were to address risk assessment issues associated with engineered nanomaterials.

    Updates for all of the projects underway by the Working Party on Manufactured Nanomaterials are the subject of Document 22, OECD Programme on the Safety of Manufactured Nanomaterials 2009-2012: Operational Plans of the Projects.

    The Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials, Document 23, provides an interesting look at how the various international jurisdictions address information requirements, hazard identification, exposure mitigation, risk assessment and risk management for manufactured nanomaterials. Interestingly, despite the fact that several of the jurisdictions (including the United States and several EU countries) are undertaking some kind of regulatory reform to address nanomaterials, most respondents “indicated that the authority to regulate substances that are nanomaterials, or products containing nanomaterials, exists in current legislation.”
  • It may only be a committee vote on draft legislation but the European Union is taking an ill-informed stance against the use of nanotechnology in food.

    On May 4th, the Parliament’s Environment Committee voted to exclude food produced using nanotechnology from the novel food list until the possible health effects can be fully assessed. In a recent EU Council press release the definition of novel foods was clarified to include nanomaterials. If adopted, the definition of novel foods will add the phrase “food containing or consisting of engineered nanomaterials is explicitly included in the scope of the regulation.” Novel foods are defined as “food not used for human consumption to a significant degree within the Community before 15 May 1997.”

    Inclusion on the novel foods list requires a risk assessment before marketing of the product is allowed and approved products would be subject to labeling requirements.

    Examples of nanotechnology in food production cited by the Environment Committee include nano-enhanced coatings on fruits and vegetables to extend shelf life and salad dressings and sauces using nanotechnology to enhance pourability. Conceding that many manufacturers are researching the use of nanotechnology in foods, the European Commission indicates that there are no “nano-foods” on the market at this time.

    Kartika Liotard, a Dutch member of GUE/NGL (Confederal Group of the European United Left/Nordic Green Left), who is steering the proposals through the European Parliament said, "we have insisted that no food products made by nanotechnology or containing nanoparticles will be put on the market unless they have undergone a validated risk assessment and are proven to be safe."

    A vote in the full Parliament is scheduled for July.
  • The Environmental Protection Agency (EPA) may not have all of the information it needs to determine if nanosilver is safe but it is able to take enforcement action on companies making unproven antimicrobial claims.

    Over $500,000 in fines have been levied against four companies (using nanoscale silver in their products) that made, but failed to prove, antimicrobial product claims. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) products that claim to kill or repel bacteria or germs are considered pesticides and must be registered with the EPA prior to distribution or sale.

    “EPA will take decisive action against companies making unverified public health claims,” said Jared Blumenfeld, Regional Administrator of EPA’s Pacific Southwest region. “Unless these products are registered with EPA, consumers have little or no information about whether their claims are accurate.”

    VF Outdoor, Inc., a California-based company marketing the North Face label, will pay $207,500 for allegedly making unsubstantiated health claims including “antimicrobial protection” and inhibiting the growth of “disease-causing Bacteria” for more than 60 shoe products. Similar claims led a fine of $220,000 for another California company, Califone International, Inc. which marketed headphones claiming “to prevent the spread of bacteria, mold and mildew for student protection.”

    Component Hardware Group of Lakewood, New Jersey and John S. Dull Associates were fined nearly $100,000 for marketing sanitizers and disinfectants to hospitals and other industries include faucets, spigots, handles, light switch and socket covers, door push and pull plates, and food service hardware. While the North Face, Califone, and Saniguard products all incorporated EPA-registered silver-based antimicrobial compounds to protect them against deterioration, they were never tested or registered to protect consumers against bacteria, fungus, mold, and/or mildew.

    “We’re seeing more and more consumer products making a wide variety of antimicrobial claims,” said Katherine Taylor, associate director of the Communities and Ecosystems Division in EPA’s Pacific Southwest region. “Whether they involve shoes, headphones, or household fixtures, EPA takes these unsubstantiated public health claims very seriously.”
  • Nanoscale silver provides an excellent example of the challenges facing the Environmental Protection Agency (EPA) in making risk-based regulatory decisions. Silver has been used for millennia and is already registered as a pesticide yet the agency has spent more time on this one substance than any other nanomaterial despite a rather vocal response from the public touting its medicinal properties rather than its hazards.

    The original petition by the International Center for Technology Assessment and 13 other organizations requested action by the EPA on an estimated 600 unregistered nanosilver products marketed in the U.S. The petition called on the EPA to regulate nanosilver as a pesticide citing the toxicity of silver and the prospect that nanosilver may be even more toxic than bulk silver.

    The Agency formed a FIFRA Scientific Advisory Panel to address questions on the evaluation of hazards and exposures from nanosilver and other nanoscale metal pesticide products and the Office of Research and Development is developing a Draft Case Study on Nanosilver which is expected to be released in June 2010.

    The EPA’s response to the citizen petition is expected to be released in June 2010 as well, according to Office of Pesticide Program Senior Policy Advisor, William Jordan. It will be interesting to see how the Agency deals with the hundreds of responses to the petition submitted to the public docket by individuals claiming a long history of colloidal silver as a medicine.
  • Anyone wishing to see an example of the changing policies at the Environmental Protection Agency (EPA) needs to look no further than the upcoming regulatory changes governing the use of nanoscale materials in pesticides.

    The primary statute used to regulate pesticides and antimicrobials is the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) but federal regulators have been largely silent on the need to address nanotechnology under the statute. The November 2009 meeting of the FIFRA Scientific Advisory Panel meeting was one of the few times the Office of Pesticide Programs (OPP) publicly addressed nanotechnology and that was only to respond to a citizen petition.

    In a presentation by OPP’s Senior Policy Advisor, William Jordan, at the recent Pesticide Program Dialogue Committee meeting acknowledged that at least one unnamed product on the market contained nanosilver but it was approved without the knowledge that it contained a nanomaterial. The product had been registered as a material preservative like many other registered silver products.

    Jordan also conceded that there are probably other registered pesticides that contain nanoscale materials and indicated that OPP will attempt to identify these products and take appropriate regulatory action. There are several pending nanopesticides applications containing nanosilver and at least one product is pending which contains halloysite, a naturally occurring aluminosilicate nanotube.

    OPP expects to issue a Federal Register Notice in June 2010 announcing a new “interpretation” of FIFRA in addition to proposing a new policy. The new interpretation is expected to provide several nano-specific approaches to the regulatory enforcement of FIFRA including: a requirement to report the presence of a nanoscale material in a pesticide product; all actives and inert ingredients will be considered “new” if it is a nanoscale material; and application of the policy for any new products or any previously-registered products. The last change could have a significant impact on products containing nanoscale silver because it will apply even though silver is already a registered pesticide.
  • The big rubber duck came out in protest of the chemical industry at the recent GlobalChem Conference in Baltimore but he didn’t have much company.

    Despite a very small turnout of protesters at the GlobalChem Conference, the Safer Chemicals, Healthy Families (SCHF) coalition has benefited from a highly successful marketing campaign that draws attention to the chemical safety issue. Richard Denison, Senior Scientist for the Environmental Defense Fund (EDF), spoke at the conference during the protest and spent much of his presentation decrying the lack of progress on the part of industry to improve chemical safety.

    EDF, which is part of the SCHF, has been a vocal critic of the Environmental Protection Agency (EPA) and Toxic Substances Control Act (TSCA) for some time. With release of the Safe Chemicals Act of 2010 there has been an outpouring of response to the bill from several key activist groups.

    In a SCHF press release following announcement of the new legislation, the organization criticized the effort by indicating the TSCA reform would: Allow hundreds of new chemicals to enter the market and be used in products for many years without first requiring them to be shown to be safe; Not provide clear authority for EPA to immediately restrict production and use of the most dangerous chemicals, even persistent, bioaccumulative, and toxic (PBT) chemicals, which already have been extensively studied and are restricted by governments around the world; and Would not require EPA to adopt the National Academy of Sciences’ recommendations to incorporate the best and latest science when determining the safety of chemicals, although the Senate bill does call on EPA to consider those recommendations.

    “We applaud Senator Lautenberg and Congressmen Waxman and Rush for introducing legislation that would dramatically improve our nation’s chemical safety system,” Denison said. “Their continued leadership will be vital, however, to make several needed improvements in the bill as it moves through the legislative process, to ensure it delivers on its promise to implement a safety system that truly protects all Americans.”

    Other organizations like the Washington Toxics Coalition continue to press for reform of chemical policies on the state level to augment inadequacies in any federal legislation.

    The Natural Resources Defense Council applauds the new legislation but also cites several shortcomings with regard to persistent and bioaccumulative substances. In addition, the organization continues to promote the no data, no market concept by requiring companies to prove a chemical is safe prior to use in the marketplace.
  • The Safe Chemicals Act of 2010 incorporates several principles supported by the chemical industry but some feel the legislation goes too far.

    The two largest trade associations for the chemical industry responded to announcement of the Toxic Substances Control Act (TSCA) reform legislation with similar but slightly different responses. The American Chemistry Council was “encouraged” by the inclusion of several of the 10 Principles for Modernizing TSCA put forth by the organization last year in an effort to shape many concepts under consideration for reform of the legislation first enacted in 1976.

    One important issue for the industry is its desire for regulatory policy based on risk rather than a requirement to conduct full batteries of tests on a substance where there is little or no risk for its intended use. In a nod to past overuse of confidentiality claims many industry officials are even in agreement that challenges to Confidential Business Information (CBI) claims are warranted and fully anticipate additional restrictions to such claims.

    The Society of Chemical Manufacturers & Affiliates (SOCMA) released a press statement indicating support for the reform effort but expressed concern about “overreaching.” The statement specifically addressed the new legislation’s requirement for priority listings of chemical substances. In a press release SOCMA indicated “The requirement that no less than 300 chemical substances be on the priority list at any given time is overly prescriptive.”

    SOCMA was also critical of EPA and Congress oversight. “Just as EPA has not fully exercised its existing authority under TSCA, Congress fell short in its responsibility to consistently oversee TSCA implementation during the past 30 years.”

    A coalition of 16 trade groups also responded to the legislation in a press release. While the chemical and chemical products industries were generally supportive, the group expressed concern about provisions allowing individual states to craft additional chemical control legislation.

    A statement by Consumer Specialty Products Association President Chris Cathcart reflects this concern. “We support a federal policy to regulate chemicals in commerce rather than a patchwork quilt of state laws that would make it difficult or even impossible to bring products to the marketplace.”
  • Andrew Schneider’s AOL series of article on nanotechnology safety raised a few eyebrows but the real eye opener came when Clayton Teague, Director of the National Nanotechnology Coordination Office (NNCO) responded to Schneider’s claims.

    The original series of articles by Schneider, The Nanotech Gamble: Bold Science, Big Money, Growing Risks, is highly critical of both industry and government for endangering the public by putting nanomaterials in the marketplace without sufficient safety data. Citing unnamed government sources and selectively describing regulator’s efforts to evaluate the safety of nanomaterials, Schneider points his finger at the National Nanotechnology Initiative (NNI) as the party failing to coordinate the safe development of nanomaterials.

    Clayton Teague took exception to the characterization and crafted his own article for AOL, Opinion: A Misleading Portrait of Nanotechnology. In particular, Teague responded to Schneider’s assertion that the NNI failed to adequately fund safety research by highlighting the total funding for 2009 and 2010 that exceeded $166 million with an additional budget request of almost $117 million for 2010.

    Interestingly, little attention was paid to the Schneider series but the repeated criticisms of its role in developing safe nanomaterials clearly touched a nerve within the NNCO. Many within both government and industry have expressed similar concerns over the continuous stream of comments by activists that nothing is being done to protect the safety of the public with regard to nanomaterials.

    Can more be done to assure the public that the development of nanotechnology incorporates a healthy dose of research on nanomaterial safety? Absolutely, but the debate will continue to linger as long as unfounded claims about safety research are allowed to circulate freely without challenging the facts. Schneider raises some excellent points about the need for responsible development of nanotechnology but to say nothing is being done in that regard is flat out wrong.
  • In what would appear to be a parallel effort to the nanotechnology information-gathering effort by the Department of Toxic Substances Control (DTSC), the California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) decided to weigh in on how nanotechnology should be regulated. The question everyone is asking though is why didn’t anyone know about the project?

    OEHHA contracted the University of California San Francisco to develop “a draft set of policy recommendations to address potential health risk from nanomaterials and nanotechnology for the state of California.” Earlier this week OEHHA released a draft document A Nanotechnology Policy Framework: Policy Recommendations for Addressing Potential Health Risks from Nanomaterials in California which “addresses the new challenges that nanomaterials present to the policy and risk assessment process because of their unique properties.”

    Many of the report recommendations have been voiced by others in terms of gathering additional information to inform regulatory risk decisions, but other recommendations are more far-reaching and should include broader stakeholder input. Some of the recommendations include: Implementation of a labeling system for products containing nanomaterials; Evaluation of nanomaterials for possible inclusion on the Prop 65 list; and Pre- and post-market testing of products containing nanomaterials.

    Curiously, little was known about this project until release of the report. Industry experts had little input to the draft report and, in reviewing the references, would appear to rely heavily on reports by the Woodrow Wilson Center for International Scholar’s Project on Emerging Nanotechnologies. Such a policy document would typically include policymakers from non-governmental organizations, academia, government and industry to incorporate as much relevant information as possible. This approach is critical to development of a regulatory framework that is based on sound science, not political rhetoric.

    Industry’s lone representative, David Warheit, is a DuPont scientist well-known for his research on nanoscale titanium dioxide. All of the other 10 representatives of the Science Advisory Panel for this project include academics, activists, U.S. Environmental Protection Agency staff and OEHHA staff.

    While it’s important to have scientists work to develop such an important document to guide regulatory policy, none of the authors or science panel members would appear to include policymakers. After all, the document purports to be creating a policy framework yet excludes policymakers from developing even the draft document.

    To make matters worse, OEHHA is holding a workshop on May 5, 2010 in Sacramento to get stakeholder input with the intention of finalizing the report at that time. With only two weeks to provide comments, it would appear that OEHHA is not serious in seeking stakeholder input and has its mind set to move forward without it. The draft document stresses the need for public education and input but OEHHA is certainly off on the wrong foot. The public did not know the document was under development, it appears that the DTSC was unaware of the effort, key stakeholders were not involved and policymakers had no input at all.
  • When the Obama administration took over last year it was widely assumed that one of the issues to be tackled would be chemical safety and regulatory policy. With the U.S. House of Representatives and the Senate announcing legislation on the same day, it’s apparent that the safe creation and use of chemical substances will be scrutinized more than ever before in the days ahead.

    Senator Frank R. Lautenberg (D-NJ) was first off the mark with a press release announcing the Safe Chemicals Act of 2010, legislation which would overhaul the Toxic Substances Control Act of 1976 (TSCA). He described the existing statute as “an antiquated law that in its current state leaves Americans at risk of exposure to toxic chemicals.” Lautenberg chairs the Senate Subcommittee on Superfund, Toxics and Environmental Health.

    “America’s system for regulating industrial chemicals is broken,” said Senator Lautenberg. “Parents are afraid because hundreds of untested chemicals are found in their children’s bodies. EPA does not have the tools to act on dangerous chemicals and the chemical industry has asked for stronger laws so that their customers are assured their products are safe. My 'Safe Chemicals Act' will breathe new life into a long-dead statute by empowering EPA to get tough on toxic chemicals. Chemical safety reform is not a Democratic or Republican issue, it is a common-sense issue and I look forward to building bipartisan support for this measure.”

    In the summary of the legislation there are several elements which appear to be incorporated from a variety of stakeholders. As suggested by industry, the EPA will “identify and prioritize chemicals by their likely risk.” However, it places the burden of proving safety on chemical manufacturers by requiring a minimum data set for all new and existing chemicals or the chemicals cannot be marketed.

    With Confidential Business Information (CBI) a concern for manufacturers the legislation further tightens requirements and, for the first time, allows sharing of CBI with “workers and local, state, Tribal and (in some cases) foreign governments as long as they protect its confidentiality.”

    Later on the same day Representatives Bobby L. Rush, Chairman of the Subcommittee on Commerce, Trade, and Consumer Protection, and Henry A. Waxman, Chairman of the Energy and Commerce Committee, released a discussion draft of legislation to amend TSCA called the Toxic Chemicals Safety Act of 2010.

    "Through the open stakeholder process that we are commencing today, I am optimistic that the discussion draft of my bill to reform the Toxic Substances Control Act will lead to a number of constructive improvements," said Subcommittee Chairman Rush. "Already, the Environmental Protection Agency, the states, industry, environmental groups and labor have provided substantial assistance to the Subcommittee on Commerce, Trade & Consumer Protection in this endeavor. This process is well worth the additional investment of time to ensure that the bill I ultimately introduce enables the EPA to better regulate, understand the properties of, and manage the health and environmental risks associated with the tens of thousands of chemicals that we find in our communities, homes, personal and work spaces, food and our bodies."

    The House action signals a willingness to continue the stakeholder dialogue to improve the legislation, something not shared with Senate colleagues. The Section-by-Section on the Discussion Draft highlights many of the same tenets as the Senate bill such as minimum data sets; establishment of a prioritization system and tightened CBI provisions.
  • The most important chemical substance regulatory statute in the U.S. is now facing challenges in many ways and some are wondering if nanotechnology is fueling the fire for change. The Environmental Protection Agency has moved beyond voluntary programs and has taken several regulatory enforcement actions which portend an even more aggressive approach toward the regulation of nanomaterials in 2010. Follow John DiLoreto’s new column in Nanotechnology Now on nanotechnology regulatory policy to keep track of impending changes which are bound to impact producers and users of nanomaterials. The first column, The Intersection of Nanotechnology and Chemical Regulatory Policy, addresses the ongoing enforcement actions for nanomaterial producers and the anticipated changes to the Toxic Substances Control Act (TSCA) which has the potential to affect nanotechnology growth and development.
  • Insurance companies have been hesitant to provide coverage to nanomaterial producers for fear of potentially huge liabilities but Lexington Insurance Company is the first to offer nano-specific liability insurance coverage in the United States.

    The insurance company, a Chartis company, introduced LexNanoShieldSM, an integrated insurance product and array of risk management services designed for firms whose principal business is manufacturing nanoparticles or nanomaterials, or using them in their processes. LexNanoShield includes liability coverage that provides protection for general liability, product liability and product pollution legal liability. The new insurance product also provides product recall coverage to reimburse expenses incurred if a product containing nanoparticles or nanomaterials is recalled from the market for safety reasons.

    “The enhanced reactivity of materials on the nanoscale has led to sunscreens you can’t see, clothes that don’t wrinkle, and paint coatings that don’t scratch. Because many of these products and others like them are relatively new, they require unique coverage and service,” said Tom McLaughlin, Lexington’s Senior Vice President of Specialty Casualty. “LexNanoShield can help insureds assess and manage these new nanotechnology exposures.”

    The potential risks associated with nanomaterials may not be fully understood and it didn’t stop one insurance carrier from taking a defensive position on potential liability. Reports of a study of carbon nanotubes (CNTs) led to a press release in 2008 by the Continental Western Insurance Group (CWIG) excluding “coverage for the, as of yet, unknown and unknowable risks created by products and processes that involve nanotubes.” The exclusion was added to make to make customers “explicitly aware of our intent not to cover injury and/or damage arising from nanotubes, as used in products and processes…”

    CWIG specifically mentioned the CNT report which linked health effects to similar effects caused by asbestos and indicated the unknown potential liability was a risk they are unwilling to accept. The poorly written exclusion reflected a lack of understanding of what constitutes a nanomaterial or even nanotechnology.

    By identifying nanotechnology rather than nanomaterials, the endorsement was so sweeping that it virtually eliminated coverage for contact with any nano-enabled product. The "endorsement excludes bodily injury, property damage, and personal and advertising injury related to the exposure of nanotubes and nanotechnology in any form. This includes the use of, contact with, existence of, presence of, proliferation of, discharge of, dispersal of, seepage of, migration of, release of, escape of, or exposure to nanotubes or nanotechnology."

    While it’s not unprecedented for liability to be restricted for emerging technologies, the action taken by Lexington Insurance reflects a growing understanding of the potential risks associated with the production and use of nanomaterials. At least one insurer is confident it can factor potential nanomaterial risks into liability equations when establishing rates and determining specific policy exclusions.
  • Just about anything on a Premanufacture Notice (PMN) submission can be claimed as confidential business information (CBI) but past failures on the part of EPA officials to challenge these claims may result in an overhaul to the Agency’s CBI policies.

    Scott Sherlock, Attorney Advisor for EPA’s Environmental Assistance Division, spoke about the CBI difficulties encountered by the Agency in recent years. Citing regulatory restrictions and resource limitations, Sherlock said “CBI changes are necessary and appropriate to increase scrutiny of EHS data submissions for new and existing chemical substances.”

    In the last 165 filings confidentiality has been claimed for the CAS number or chemical substance name for 95 submissions. Future submissions will be different, however, as Sherlock announced that company names, contacts, and site addresses may no longer be considered confidential information. PMN submitters will need to scrutinize submissions for CBI claims and the EPA has asked that companies review previous CBI claims on PMNs in an effort to make more information publicly available.

    Even within the chemical industry many have decried the overuse of CBI claims because it also prevents the EPA from sharing the information with other state and foreign governments. This ultimately leads to costly additional submissions by companies in order to meet regulatory requirements in other jurisdictions.

    The Agency recently removed over 500 chemical substances from the confidential portion of the TSCA Inventory when it discovered that information claimed to be confidential on PMN submissions was publicly available on company web sites.
  • The President's Council of Advisors on Science and Technology (PCAST) declared the National Nanotechnology Initiative (NNI) a success in a report to the President.

    PCAST’s mandated review of the NNI highlighted several successes in the U.S. effort to remain a leader in the global commercialization of nanotechnology. In the Report to the President and Congress on the Third Assessment of the National Nanotechnology Initiative, PCAST members believe that nanotechnology investments have had a “’catalytic and substantial impact’ on the growth of the U.S. nanotechnology industry.”

    While assessing NNI’s performance in the categories of program management, nanotechnology outcomes and environment, health, and safety (EHS), PCAST members also provided a host of recommendations to strengthen the National Nanotechnology Initiative.

    Key EHS recommendations in the report include: the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee’s interagency working group on Nanotechnology, Environmental, and Health Implications (NEHI) should develop clear principles to support the identification of plausible risks associated with the products of nanotechnology; the NSET Subcommittee should implement organizational changes that support consequential cross agency action on addressing nanotechnology EHS issues; the NSET Subcommittee’s NEHI working group should develop publicly-available information resources on cross-cutting nanotechnology EHS issues that are relevant to businesses, health and safety professionals, researchers and consumers; and the National Nanotechnology Coordinating Office should specify an individual who would lead interagency coordination of efforts in the area of EHS.
  • The Environmental Protection Agency (EPA) got what they wanted in the way of an initial response to the Nanoscale Materials Stewardship Program (NMSP) but was disappointed that the submissions relied on existing information without many commitments to develop new safety data. As a result, regulations are under development to get the data needed for science-based decision-making.

    The EPA Hot Topics session at GlobalChem drew overflow crowds of people wanting to gain a better understanding of the Agency’s front-burner issues and they were not disappointed. Jim Willis, Director of the OPPT’s Chemical Control Division provided insight on the reasons for disappointment in the NMSP submissions.

    With 31 companies submitting reports, 132 unique nanomaterials were identified (12 of 14 materials covered by the Organisation for Economic Co-operation and Development (OECD)) but only 58 TSCA chemicals were listed in the submissions.

    To strengthen the existing data set for nanomaterials, Willis indicated there will be several steps taken by the Agency this year: Significant New Use Rules (SNURs) for any new nanomaterials on chemicals listed on the TSCA inventory; Section 4 Test Rules for data development needs; Section 8(a) rules to fill targeted data gaps for certain nanomaterials already on the market; and Strong engagement in international work, states and other federal agencies.

    To assist the EPA with its decision-making, Willis suggested the need for specific tools to evaluate the safety of nanomaterials including: Predictive tools; Decision analysis tools; and Life-cycle analysis tools.

    Surprisingly, the EPA has been quietly taking enforcement actions against nanomaterial producers over the last year. Two-thirds of all enforcement actions taken by the Agency last year fell into this category according to Michael Bellot, Chief of the Chemical Risk and Reporting Enforcement Branch in the Office of Enforcement and Compliance Assurance.

    The regulatory actions planned in 2010 will be augmented with increased penalties of up to $37,500 per violation. To give enforcement officials even more ammunition, the Agency is planning to go after all economic benefits received from noncompliance in addition to the fines.
  • For some time now the Environmental Protection Agency (EPA) has been evaluating its enforcement options for nanomaterials and it seems that 2010 will be the year that regulatory activities hit their stride.

    EPA Administrator Lisa Jackson's speech to the Commonwealth Club of San Francisco in September set the tone for the Agency’s 2010 regulatory plans by laying out principles for the safety assessments of chemical substances. She did not specifically mention nanomaterials but a press release on the speech highlighted difficulties associated with the regulation of nanoscale materials.

    "An additional focus will be accelerating efforts to gather the critical information from industry that the agency needs to make chemical risk determinations. This will include filling the current gaps in health and safety data on high production volume chemicals; enhanced, transparent, and more current reporting of use and exposure information; and a number of requirements for increased reporting on nanoscale chemical materials. In addition, EPA is reviewing how nanoscale materials are managed under TSCA. EPA is also reviewing ways to increase the public's access to information about chemicals."

    This theme was repeated several times by virtually every EPA speaker at the GlobalChem Conference recently held in Baltimore, MD. Jim Jones, Deputy Assistant Administrator of the Office of Prevention, Pesticides and Toxic Substances, reinforced Jackson’s principles by indicating the Agency will strive to make risk-based regulatory decisions but reiterated that manufacturers should be responsible for providing safety data on new and existing chemical substances. He said green chemistry should be encouraged and provisions assuring transparency and public access to safety information should be established. Not wanting to miss an opportunity to garner fiscal support for the Agency’s efforts, he also suggested the EPA “should be given a sustained source of funding for implementation.”

    Wendy Cleland-Hamnett, Director of the Office of Pollution Prevention & Toxics indicated that 2010 would be a very busy year for the Agency. She said there would be an “enhanced program” of new regulatory risk actions and she specifically called out lead, mercury, formaldehyde, PCBs, glymes and nanomaterials. Citing “disappointing results” for the voluntary Nanoscale Materials Stewardship Program, Cleland-Hamnett detailed regulatory risk actions under development to ensure that existing nanomaterials receive appropriate regulatory review including: Section 5 SNURs; Section 8 Mandatory Data Submission; and Section 4 Test Rules.

    Given the climate for increased regulatory actions to bolster chemical safety efforts, the anticipated changes to the Toxic Substances Control Act (TSCA) and the new administration’s desire for a more open and transparent decision-making process, we will probably be hearing more about additional regulatory actions in the days ahead.
  • The use of nanotechnology in foods is rapidly growing and the food industry is facing increasing pressure to be more transparent about its research and use of nanotechnologies and nanomaterials.

    The United Kingdom House of Lords Science and Technology Committee recently released : Nanotechnologies and Food, which examined the growing use of nanotechnologies in food and food products. While encouraging greater use of the national strategy for nanotechnology to include food uses, it also recommends the increased funding of research into the risk assessment of nanomaterials in foods and food contact materials.
  • The importance of safety in the workplace is frequently discussed in the nanomaterial safety debate but even working with small quantities in the laboratory can provide an element of risk.

    Researchers from the U.S. Army Engineer Research and Development Center and the National Institute for Occupational Safety and Health attempted to produce conditions similar to those found in natural surface water to evaluate the potential of laboratory personnel exposure to carbon-based nanomaterials (CNMs). The research can provide insight to the potential release of these nanomaterials when laboratory personnel conduct tests to evaluate the impact of nanomaterials in environmental matrices.

    The study, : Potential for Occupational Exposure to Engineered Carbon-Based Nanomaterials in Environmental Laboratory Studies, measured the release of fullerenes, multiwalled carbon nanotubes and carbon black into the air during handling and mixing by sonication. Key findings indicate an increased risk of exposure to engineered nanomaterials and recommended the use of engineering controls and protective equipment.
  • The Toxic Substances Control Act (TSCA) is a key regulatory tool for regulating the safe production and use of nanomaterials but the Environmental Protection Agency’s (EPA) Office of Inspector General criticized the Agency’s failure to use all of the enforcement mechanisms already authorized under the legislation.

    TSCA reform is a looming issue in front of the U.S. Congress because many people believe the legislation originally enacted in 1976 does not provide a framework to adequately ensure the introduction of chemical substances into the marketplace. However, the Office of Inspector General’s report, : EPA Needs a Coordinated Plan to Oversee Its Toxic Substances Control Act Responsibilities, pointed out the many ways the Agency could be using its existing authority to better implement a regulatory program.

    The key conclusion of the report highlights the lack of “a coordinated process for ensuring risk mitigation from new chemicals.” Nanotechnology critics often point this out and use it as a rationale for scrapping TSCA in favor of a more comprehensive piece of legislation that will be more like the European Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) framework which embodies the “no data, no market” principle.

    EPA officials agreed to implement the recommendations in the report which include increased enforcement of existing regulations, plans to request statutory authority to increase Premanufacture Notice fees for review costs and development of “a more detailed TSCA CBI [Confidential Business Information] classification guide that provides criteria for approving CBI coverage and establishes a time limit for all CBI requests to allow for eventual public access to health and safety data for chemicals.”
  • At least a dozen federal agencies could share over $1.76 billion for nanotechnology research and development projects with a modest increase in funding for safety research.

    The National Nanotechnology Initiative (NNI) proposed budget for FY 2011 allocates funds to be targeted in eight program component areas (PCAs): Fundamental Nanoscale Phenomena and Processes; Nanomaterials; Nanoscale Devices and Systems; Instrumentation Research, Metrology, and Standards; Nanomanufacturing; Major Research Facilities and Instrument Acquisition; Environment, Health, and Safety (EHS); and Education and Societal Dimensions.

    The EHS PCA has been one of the fastest growing areas of NNI research funding, increasing from $35 million in FY 2005 to a proposed $117 million in the FY 2011 request. Nanomanufacturing funding has also shown steep increases from $34 million in FY 2006 to $101 million in the FY 2011 request. Increased funding in these areas reflects a shift of nanotechnology research to large scale production with an eye toward safety.

    Department of Defense (DOD) funding for nanotechnology research has slowed dramatically while the Department of Energy (DOE) is now the recipient of the largest amount of funding through the NNI. Despite the increases for safety research, DOD, DOE, National Science Foundation and the National Institutes of Health still receive the lion’s share of research funding with over 88% of the budget dedicated to those agencies.
  • There may be some commonly accepted definitions of nanomaterials but every regulatory body would appear to have its own needs.

    The European Commission has requested a scientific opinion for a scientific basis for the definition of nanomaterial “to guide as appropriate, the effective implementation of existing regulation, and to contribute to international work and dialogue on nanotechnology definitions.”

    The European Commission has indicated a need for clarification of size ranges and the physical/chemical properties that are important to establish a regulatory regime. The request made to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) is described as urgent which may indicate movement on the regulation of nanomaterials under REACH.

    The ISO TC 229 Nanotechnologies Technical Committee has worked on terminology and nomenclature issues for the past few years and would appear to be close to consensus. Health Canada’s recent adoption of an interim policy on a working definition of nanomaterials is one example of government regulatory agencies that need to put into place such a definition to develop policy, guidance, and programs applicable to nanomaterials.

    The SCENIHR has been given until May 2010 to provide its response to the European Commission.
  • It has been expected for some time but Canada has finally taken the initial steps to regulate the production and use of nanomaterials.

    For over 2 years Environment Canada has been sending signals about a mandatory data collection program for nanomaterials but on March 1, 2010 Health Canada posted an Interim Policy Statement on Health Canada’s Working Definition for nanomaterials on its website. This interim policy is expected to be revised over time in response to comments but it does take effect immediately.

    The key objectives of this policy statement are to: Establish a working means of identifying nanomaterials; Assist Health Canada to collect information and establish internal inventories regarding products, materials, substances, ingredients, devices, systems or structures that are, contain, or make use of nanomaterials; Support communications about nanomaterials with the broader community of interested stakeholders; and Support the administration of the legislative and regulatory frameworks under the authority of Health Canada and to help further the development of policy, guidance and programs applicable to nanomaterials.

    Health Canada has established a working definition of nanomaterials for this policy. It is a nanomaterial if it is at or within the nanoscale (1 to 100 nanometers) in at least one spatial dimension or if it is smaller or larger than the nanoscale in all spatial dimensions and exhibits one or more nanoscale phenomena. The policy’s definition of nanoscale phenomena does appear to specifically address differences in toxicity when the material is manufactured at the nanoscale and this could be interpreted to include any phenomena (electrical, optical, etc.) which is different at the bulk material scale.

    In an effort to gather sufficient scientific information on nanomaterials to establish a regulatory program, Health Canada acknowledges the definition “casts a wide net so that diverse program areas and legislative and regulatory authorities across Health Canada can request and collect necessary information for nanomaterials characterization and nanoscale measurement.”

    In preparing the Interim Policy, Health Canada sought the informal feedback of some international stakeholders, industry trade groups, standards associations, and other Canadian federal departments. Comments on the policy are due by August 31, 2010.
  • The National Nanotechnology Initiative has extended an invitation to be one of the voices in an active discussion to: Probe the state of the science for risk management methods and the ethical, legal, and societal implications of nanotechnology; Identify priority gaps and emerging trends in nanotechnology-related environmental, health, and safety research; and Provide comment on the recommendations in the National Nanotechnology Initiative’s Strategy for Nanotechnology-related Environmental, Health, and Safety Research.

    For details on the meeting location, registration and hotel accommodations click here.
  • The UK’s House of Lords Science and Technology Committee recommends “the Food Standards Agency create and maintain a list of products containing nanomaterials as they enter the market.” The committee conducted an “inquiry into the use of nanotechnologies in the food sector to investigate whether nanotechnologies may indeed play a valuable role in the food sector, whether effective systems are in place to ensure that consumers are aware of and protected against any potential risks, and to understand and address some of the concerns that the public may have about these new technologies.” As you might expect there are differing opinions on the conclusions drawn by the committee particularly when there are claims that the food and food packaging industries have been too secretive about its nanotechnology research.

    The House of Lords Report, can be found here and an industry response here.
  • The Environmental Protection Agency’s (EPA) Scientific Advisory Panel (SAP) released the minutes of November’s meeting on the safety of nanoscale silver and at least one industry group is still concerned about the recommendations.

    The report, A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding: Evaluation of the Hazard and Exposure Associated with Nanosilver and Other Nanometal Pesticide Products, reflects concern among panelists that existing safety information on both bulk and colloidal silver do not provide enough information to accurately assess the risks associated with nanoscale silver.

    In at least one important area the Panel agreed that size matters with the effects of particle size “most observable in particles below 20 nm and largely below 10 nm.” According to the document most members of the Panel are “unsupportive of bridging among silver-based materials with different properties” because they lacked a clear understanding of the properties that impact hazard profiles.

    Due to the level of uncertainty of the relationship between particle size and toxicity, the Panel placed little value in existing risk assessment models for use with silver nanomaterials. Also, with the high level of certainty regarding the effects of agglomeration, it will be difficult to evaluate the environmental impact of nanomaterial releases.

    The Silver Nanotechnology Working Group (SNWG) made a presentation at the November meeting and took issue with report. SNWG encouraged the EPA to consider the long record of safe use of silver and reiterated its long-held stance that nanosilver is not a new material from a regulatory perspective.

    The Panel has not announced additional meetings at this time.
  • French activists have found a unique way to disrupt a series of public debates on nanotechnology.

    In what can best be described as a raucous event, environmentalists employed loud and disruptive tactics to prevent a full-scale debate on the merits of nanotechnology. As soon as Jean Bergougnoux, chair of the panel in charge of France's national debate on nanotechnology, opened the debate with welcoming remarks activists began shouting, whistling, and jeering to prevent speakers from being heard.

    Video of one of the debates in Lyon puts on display an almost comical series of events which seem to baffle event organizers. When the activists unfurled banners decrying nanotechnology as the “asbestos of the 21st century” and that “nano is not green” organizers seemed incapable of handling the demonstration. After about an hour of attempting to gain control over the debate organizers moved the debate to a back room to webcast the event.

    France's Special Commission for the Public Debate on Nanotechnology organized discussions in 17 cities to inform the public about benefits and risks associated with nanotechnology and to give the public an opportunity to express their opinion. Environmentalists do not accept the legitimacy of the debates and intend to continue their disruptive tactics. Perhaps organizers will consider having some security present to allow the debates to continue without interruption.
  • The Environmental Protection Agency (EPA) continues to use its existing Toxic Substances Control Act (TSCA) authority to regulate nanomaterials.

    On February 3, 2010, the EPA published another proposed rule specifically for multi-walled carbon nanotubes (MWCNTs) described in premanufacture notice (PMN) P08-199. The SNUR “will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of the specific multi-walled carbon nanotubes identified by the notice for any activity designated by this SNUR as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs.”

    The first SNUR drew some comments regarding the prohibition on “predictable or purposeful” releases into water and the comment period was ultimately extended at the request of the U.S. WTO TBT Inquiry Point at the National Institute of Standards and Technology to further evaluate the proposed regulation.

    In the basis for action in the latest federal register notice the “EPA identified concerns for lung effects, immunotoxicity, and mutagenicity from exposure to the PMN substance.” In addition, the EPA notice establishes a requirement for: A bacterial reverse mutation test in vitro; a mammalian erythrocyte micronucleus test in vivo, in bone marrow, by the intraperitoneal route; an immunotoxicity test; and a 90-day inhalation toxicity test, including a post-exposure observation period of up to 3 months.

    The Agency made it very clear in the latest notice that it only applies to the specified PMN material and is not intended to establish a generic regulatory requirement for all carbon nanotubes. Comments may be submitted until March 5, 2010.
  • Despite many shifts in funding among government agencies, the proposed National Nanotechnology Initiative (NNI) FY 2010 budget includes a modest increase for health and safety.

    The proposed budget across all government agencies increased from $1.527 billion to $1.639 billion despite shifting funds among the agencies which reflects a general reprioritization on nanotechnology research within the federal agencies. In the last two budget years the largest recipient of NNI funding has been the Department of Defense (DoD) but this year the National Science Foundation would get $423 million, $45 million more than the DoD.

    The NNI budget breaks down the requested funding into 8 different program areas: Fundamental nanoscale phenomena and processes; Nanomaterials; Nanoscale devices and systems; Instrumentation research, metrology, and standards; Nanomanufacturing; Major research facilities and instrument acquisition; Environmental, health, safety (EHS); and Education and societal dimensions.

    The overall increase for EHS and Societal Dimensions program component areas from $117.1 million to $123.8 million represents a modest increase of 5.7% although the budget still falls below the threshold sought by many for adequate funding of EHS research by the federal government. Representatives from industry and non-governmental organizations sought to have at least 10% of the NNI fund to be allocated to EHS research and the current budget reflects funding at 7.6%.

    One big winner in the proposed budget is the National Institute of Occupational Safety and Health (NIOSH) which would receive $12.4 million in FY 2010. In the last two years NIOSH received $6 million each year and in past years has reallocated internal funds to provide leading edge research on occupational safety in the nanotechnology workplace.

    With food and nanotechnology becoming a major issue, one might anticipate that food safety would receive some attention but the allocation of only $400,000 for EHS at the Department of Agriculture does not appear to reflect any sense of urgency on nanotechnology-related food safety.
  • The Food and Drug Administration (FDA) has been largely silent on nanotechnology despite some public meetings. New proposed legislation may give the agency the funding it needs to address the issue, hopefully in a more transparent way.

    S. 2942, cosponsored by U.S. Senators Mark Pryor (D-AR) and Benjamin L. Cardin (D-MD), would establish a program within the FDA “to assess the health and safety implications of nanotechnology in everyday products and develop best practices for companies who employ nanotechnology.” To provide funding for the effort the Nanotechnology Safety Act of 2010 authorizes $25 million each year from 2011 through 2015.

    If passed, the bill would require the Secretary of Health and Human Services, in consultation with the Secretary of Agriculture, to “establish within the Food and Drug Administration a program for the scientific investigation of nanoscale materials included or intended for inclusion in FDA-regulated products, to address the potential toxicology of such materials, the effects of such materials on biological systems, and interaction of such materials with biological systems” within 180 days.

    Many have wondered where the FDA stands on the increasing use of nanoscale materials in pharmaceuticals and medical devices. The FDA has emphasized the effectiveness of its existing safety evaluation processes and expressed confidence that the existing procedures address safety concerns regarding nanoscale materials.

    In August 2006 the agency announced the creation of an internal Nanotechnology Task Force which issued a report in July 2007 posing questions regarding “the adequacy and application of our regulatory authorities.” The report provided recommendations on covered foods, (including dietary supplements), food and color additives (including food contact substances), animal drugs and feeds, cosmetics, human drugs and biologics, and medical devices.

    The FDA considered development of agency “guidances” and a public meeting was held on September 8, 2008 to “assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report.” Over 300 people attended but many left the meeting wondering when the agency is going to have some answers rather than still asking questions.
  • A last-minute rush of submissions to California’s data call-in on carbon nanotubes is over and now a review is underway to evaluate the quality of both the submissions and the questions industry was asked.

    As promised by the Department of Toxic Substances Control (DTSC) Chief Scientist Dr. Jeff Wong, all of the responses have been made publicly available on the DTSC web site. Responses were received from 16 companies, academic institutions and national laboratories including Bayer MaterialSciences, Cnano, Unidym, Lawrence Berkeley and Livermore National Laboratories, Stanford University and the University of Southern California.

    The DTSC call-in got no response from Apex Nanomaterials, California State University, Graphene Solutions and the University of Affiliated Research Center/NASA Ames. At least three companies missed the deadline but have indicated that responses will be provided.

    In order to determine if the response are sufficient, all of them will be evaluated and a report on the data call-in effort will guide future regulatory action on carbon nanotubes as well as the process for future data call-ins on other nanomaterials.
  • Three legislators would like the Wisconsin Assembly to study the feasibility of a registry to “monitor the use, manufacture, and disposal of nanomaterials” in the state.

    In late 2007 Wisconsin Representative Terese Berceau wrote a letter to the Departments of Natural Resources, Health and Family Services and Agriculture, Trade and Consumer Protection calling for the establishment of a policy to require private companies that manufacture nanoparticles to disclose information about the types of particles they're making.

    Read her latest letter here.
  • Japan’s Research Institute of Science for Safety and Sustainability has released English translations of risk assessments of three nanomaterials: Titanium Dioxide, Fullerenes and Carbon Nanotubes.

    Download the Executive Summaries of the risk assessments here.
  • The Environmental Protection Agency was discouraged by the results of the Nanoscale Materials Stewardship Program (NMSP) but how does it compare to other voluntary programs?

    An analysis conducted by the Organisation for Economic Co-operation and Development’s (OECD) Working Party on Manufactured Nanomaterials (WPMN) looked at reporting schemes across the globe and offered recommendations for member countries to consider. The Analysis of Information Gathering Initiatives on Manufactured Nanomaterials reviewed completed or anticipated voluntary schemes and regulatory programs in the United States, Australia, Canada, Denmark, Germany, Ireland and the United Kingdom.

    The U.S., U.K. and Australia all had a stated purpose of gathering information to build a baseline set of information on use patterns and physico-chemical properties that would ultimately inform existing or developing regulatory programs. All of these countries targeted manufacturers and importers, while the U.S. and the U.K. also sought information from users. The U.S. NMSP also sought information from processors and researchers.

    The approach taken by Germany, Denmark and Ireland to gather information differs in that surveys were the primary tool used to obtain information on use patterns and occupational safety. Only companies producing more than 10 kilograms per year of nanomaterials were asked to participate in the survey. In Denmark, a consultant carried out the project which targeted manufacturers.

    Canada has not yet initiated an information gathering program but it is expected to be mandatory rather than voluntary.

    While not passing judgment on the success or failure of any individual program, the report provided several recommendations on the type of information that should be gathered, the length of the programs and ways regulatory officials can assist the targeted audience in providing information.

    One of the recommendations on the length of time to submit information would appear to reflect a realization that giving submitters more time does not improve the response rate or the quality of the responses. Deadlines in the 2-6 month range are suggested unless submitters are expected to generate new information.

    The recommendations also suggest that some information be considered mandatory rather than be part of a voluntary initiative. Information on who is manufacturing or importing nanomaterials, what nanomaterials or being manufactured or imported, current and expected uses and any existing safety information should be provided under a mandatory program.

    The analysis has the benefit of seeing how several voluntary programs have succeeded (or failed) which will allow other regulatory officials to learn from the mistakes of others who went before them.
  • Bayer Material Sciences (BMS) is one of the first companies to establish occupational safety standards specifically for carbon nanotubes.

    As part of a product stewardship plan, BMS cited the results of recent sub-chronic inhalation studies in the development of an Occupational Exposure Limit (OEL) of 0.05 mg/mg3. The standard is now being added to all updated BMS Safety Data Sheets to “ensure that our customers work safely with our Baytubes” according to a recent announcement.

    Recent inhalation studies of Baytubes include Pulmonary Toxicity of Multi-Walled Carbon Nanotubes (Baytubes) Relative to Alpha-Quartz Following a Single 6h Inhalation Exposure of Rats and a 3 Months Post-Exposure Period and Subchronic 13-Week Inhalation Exposure of Rats to Multiwalled Carbon Nanotubes: Toxic Effects Are Determined by Density of Agglomerate Structures, Not Fibrillar Structures.
  • The Environmental Protection Agency (EPA) moved beyond voluntary programs and took several regulatory enforcement actions which portend an even more aggressive approach in 2010.

    The desire on the part of the Obama administration to institute a proactive chemical management policy will drive accelerated regulation of existing chemicals as well as impact the EPA’s regulatory approach to nanomaterials. Last September, EPA Administrator Lisa P. Jackson announced “core principles” for the administration’s approach to TSCA modernization. The press release that announced the Essential Principles for Reform of Chemicals Management Legislation specifically mentions nanoscale materials as a target for review.

    Agency officials were disappointed over results of the voluntary Nanoscale Materials Stewardship Program have taken a posture which uses regulatory tools rather than voluntary compliance. Significant New Use Rules (SNURs) for carbon nanotubes were promulgated in 2009 and, despite some delays, has resulted in modified consent orders which place reporting requirements on producers with similar actions previously taken on siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles.

    A more far-reaching tool available to the EPA is the TSCA section 4(a) test rule. In the spring 2009 Unified Agenda the Agency indicated the test rule may be needed to determine the health effects of multiwalled carbon nanotubes. While the use of test rules and SNURs as regulatory tools can help accomplish the goal of “understanding the health effects of the substance to manage/minimize any potential risk and exposure,” it is expected that TSCA “modernization” can be used to enhance existing enforcement capabilities and add new regulatory enforcement capabilities for nanoscale materials.
  • A request to reopen the comment period for a proposed rule on carbon nanotube (CNT) Significant New Use Rules (SNURs) has led to an extension of time.

    The original comment period was to end of December 7, 2009 but a request by the U.S. WTO TBT Inquiry Point at the National Institute of Standards and Technology to extend the deadline has led to a 30-day extension to allow the European Economic Community an opportunity to further evaluate the proposed regulation.

    Additional comments have already been received which highlight some of the complexities associated with the Premanufacture Notice (PMN) evaluation process. Nantero, Inc. raised concerns about the prohibition on “predictable or purposeful” releases into water. In addition to asking for clarification on what constitutes “predictable or purposeful” releases, Nantero asked for a standard which allows for “small but arguably predictable losses associated with well designed filtration systems without triggering notice obligations.”

    Nantero also suggested that worker protection controls focus on “substances in a dry, unbound, free particulate form” which presents a more relevant inhalation exposure possibility.

    Another set of comments by James Votaw of WilmerHale points out that the proposed SNURs are legally insufficient because they do not provide a rational basis for the prohibition on discharges to water “without any record determination connecting the restriction to a relevant environmental or human health concern.”

    Comments on the proposed rule must now be submitted by February 8, 2010.
  • The complexities surrounding the regulation of nanomaterials are well known and the citizens of Australian have a chance to review an initiative to “introduce new approaches to the regulation of industrial nanomaterials.”

    National Industrial Chemicals Notification and Assessment Scheme (NICNAS) stakeholders have been asked for input on the Proposal for Regulatory Reform of Industrial Nanomaterials: Public Discussion Paper. The NICNAS Nanotechnology Advisory Group incorporated proposal recommendations from industry, the community, and research sectors.

    Mirroring many regulatory policy issues in Europe and the U.S., the NICNAS proposal contains three key elements for the regulation of nanomaterials: 1) Regulation of nanoforms of new chemicals; 2) Regulation of nanoforms of existing chemicals; and 3) The principle of an integrated approach for industrial nanomaterials within the NICNAS framework as a longer term strategy.

    The proposal includes several attached documents to assist stakeholders in evaluating the strategy including: Overarching Principles of NICNAS Regulatory Strategy; an Indicative List of Nanomaterials; Findings from Monash University Report; an Overview of International Activities; an Overview of NICNAS New Chemical Notification Categories; a Proposed Strategy Nano-forms of New Chemicals; and a Proposed Model for Mandatory Notification & Assessment Program.

    Public comments on the strategy will be accepted until December 23, 2009.
  • Despite concerns expressed by Germany, the EU Council enacted a regulation requiring the labeling of cosmetic products containing nanoscale materials. The regulation, which consolidates and updates several regulations pertaining to cosmetic ingredients, requires ingredient listings to include the work ‘nano’ for any ingredients at the nanoscale in the formulation. Publication of the regulation in the Official Journal of the European Union is expected in the next few weeks and implementation of the regulation would take effect three and a half years later. In defining a nanomaterial, the regulation more or less follows a commonly accepted definition as “an insoluble or biopersistant [sic] and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”

    The new regulation incorporates existing rules which require market approval for nanomaterials used as colorants, preservatives, and UV filters. The new rule extends the regulatory requirements by specifically identifying nanomaterials in cosmetic products.

    The lack of a standard definition of nanomaterials is acknowledged in the new regulation. “The use of nanomaterials in cosmetic products may increase with the further development of technology. In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at [the] international level. The Community should endeavour to reach an agreement on a definition in appropriate international fora. Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly.”

    Also, the regulation acknowledges the need for additional data on nanomaterial safety. “At present, there is inadequate information on the risks associated with nanomaterials. In order to better assess their safety the SCCS should provide guidance in cooperation with relevant bodies on test methodologies which take into account specific characteristics of nanomaterials.”

    German objections highlighted in a statement released by the Council of the European Union focused on public perception of the labeling mandate. “With regard to the introduction of labeling for nano particles in cosmetic products (Article 19(1)(g)), it cannot in Germany's view be excluded that the general mention on labels of nano-scale materials in cosmetic products using the term ‘nano’ might be misunderstood by consumers as a warning. Because of the general safety requirements for cosmetics, it is in any case only safe products that are allowed on the market. This applies also to cosmetics which are produced using nanotechnology. Germany believes that information on nano-scale materials may be important for consumers where the particle size results in altered properties.”
  • Seven nanomaterials have been added to TOXNET’s Hazardous Substance Data Bank.

    The National Library of Medicine recently announced the addition of the seven nanomaterials to the Hazardous Substance Data Bank (HSDB) which includes toxicology data for about 5,000 chemicals. The added nanomaterials include carbon nanotubes, fullerenes, silver nanoparticles, iron nanoparticles, titanium oxide nanoparticles, zinc oxide nanoparticles and cerium oxide nanoparticles.

    HSDB is peer-reviewed by the Scientific Review Panel, a committee of sixteen experts in major subject areas such as toxicology, chemistry, pharmacology, industrial hygiene, medicine, emergency response procedures, environmental science, hazardous waste handling, and regulatory requirements. The panel meets three or four times a year to conduct a comprehensive review of the scientific information in new and updated chemical records.
  • The National Institute for Occupational Safety and Health (NIOSH) continues to be on the leading edge of nanotechnology workplace safety issues with updates to two research reports.

    Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center, Project Updates for 2007 and 2008 highlights achievements during that time period. Since NIOSH established the Nanotechnology Research Center (NTRC) in 2004, it has focused on four main goals: 1) Determine whether nanoparticles and nanomaterials pose risks of work-related injuries and illnesses; 2) Conduct research to prevent work-related injuries and illnesses by applying nanotechnology products; 3) Promote healthy workplaces through interventions, recommendations, and capacity building; and 4) Enhance global workplace safety and health through national and international collaborations on nanotechnology research and guidance.

    The document describes 43 projects completed or underway which provide the basis for achieving its goals. It would be difficult to disagree with the NIOSH assertion in the report that the organization “continued to make contributions to all the steps in the continuum from hazard identification to risk management.”

    The second research report, Strategic Plan for NIOSH Nanotechnology Research and Guidance: Filling the Knowledge Gaps, updates the September 2005 strategic plan using knowledge gained from results of ongoing research. According to the NIOSH web site, “the Strategic Plan for the nanotechnology program is the roadmap we are using to advance knowledge about the implications and applications of nanomaterials.”
  • The latest nanotechnology symposium featured safety and regulatory experts that highlighted industry efforts.

    The California Nanotechnology Industry Network sponsored the latest nanotechnology symposium at the State of California’s Department of Toxic Substances Control (DTSC) with some of the nation’s best-known experts from academia and industry. NanoReg is a member of the California Nano Industry Network which is a network of corporations and State and national trade associations.

    Two major themes were highlighted in the workshop to show the broad range of global collaborations on nanotechnology safety and how some of the knowledge already gained from the collaborations is being employed in industry. The symposium was webcast and the recording will be made available on the DTSC web site shortly. A video of some of the presenters is already available on YouTube.

    Dr. Jeffrey Wong, DTSC Chief Scientist, played a key role in coordinating industry participants after concerns that industry stakeholder views had not been heard in earlier symposia. In a unique format for stakeholder workshops, industry presenters were critiqued and challenged with provocative questions from Timothy Malloy, UCLA Professor of Law and Co-Director of the Frank G. Wells Environmental Law Clinic, and Patricia Holden, Professor of Environmental Microbiology, Bren School of Environmental Science & Management at UCSB.

    Dr. Andrew Maynard, Chief Science Advisor to the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars as moderator. Dr. Maynard gave an overview of emerging nanomaterials safety, health and environmental issues and provided insight on the complexity of these issues.

    The symposium provides a backdrop to future data call-ins and ongoing engagement with industry. Dr. Wong has indicated that future call-ins will include dendrimers, nanoscale metal oxides, nanosilver, reactive nanometals and quantum dots. Another possibility mentioned by Dr. Wong is that data call-ins may be industry-specific with clothing and textiles a likely candidate. With limited resources and uncertain funding for the near future, DTSC action on the call-ins will be spread out over the next few years.
  • This webinar will focus on how nanotechnology offers life-transforming benefits in areas such as personalized medical care, next generation cancer treatments, energy efficiency, innovative consumer products and water purification. What is it, then, that is causing us to have a heightened sense of vulnerability about nanotechnology's ability to benefit society? This webinar will offer valuable perspectives and concrete recommendations from seasoned experts concerning product safety and what companies making or working with nanomaterials should be doing.

    The webinar is fourth in the popular series, Nanotechnology Today, sponsored by NanoReg & Keller and Heckman LLP.
  • It comes as no surprise that socks containing nanoscale silver release the antimicrobial product when the socks are washed. The real questions needing answers are how much is released and what size silver particle is released?

    The latest study by Swiss researchers published in Environmental Science and Technology, The Behavior of Silver Nanotextiles during Washing, provides insight into the amount and size of silver particles of released during routine household wash cycles. Researchers used nine different fabrics with a variety of methods used to incorporate silver into each fabric.

    Variables such as pH were factored into the study as well as the potential effects caused by bleaching agents. While the quantity of silver released was dependent on the amount of silver incorporated into the fabric, the percentage of silver released during the wash was impacted by the pH of the water.

    At a pH of 7 the silver particles dissolved at a higher rate than at a pH 10 while bleaching agents greatly accelerated the dissolution of silver. While the percentage of silver released was highly variable (1 to 45%) the majority of the silver released (50 to 75%) was larger than 450 nanometers. This fact led researchers to conclude the results “have important implications for the risk assessment of Ag-textiles and also for environmental fate studies of nano-Ag, because they show that under conditions relevant to washing, primarily coarse Ag-containing particles are released.”
  • While no one was paying attention, the organic foods industry considered steps to ban all nanotechnology products in foods, processes and packaging.

    Dozens of comments were submitted prior to a recent meeting of the National Organic Standards Board (NOSB) where the Materials Committee recommended a prohibition of all that is nanotechnology. The comments reflect a nearly universal sentiment among consumer groups that there is no place for nanotechnology in the organic industry.

    With over 60 speakers at the recent meeting in Washington, DC only two speakers questioned the rationale for the prohibition and took exception to a draconian attempt to regulate a whole technology rather than individual substances. If adopted, the prohibition would not allow hard surfaces with nanoscale antimicrobials, food products enhanced with nanoscale materials or packages that incorporate nanomaterials.

    NanoReg’s John DiLoreto provided comments to the NOSB in an effort to inform the Board on the implications of such a ban for the organic foods industry and the potential effects on related industries. Betty Bugusu of the Institute of Food Technologists echoed these comments in addition to providing a recommendation to use sound science in the decision-making process rather than emotional anecdotes by concerned consumers.

    Many speakers went in the opposite direction with their comments. Most wanted to ban nanotechnology in any form to keep it from entering the organic foods supply chain or even allow its use in packaging. A frequent recommendation in the public comments included altering the definition of nanomaterials to include all engineered nanomaterials less than 300 nanometers in any dimension.

    In considering all of the public comments the NOSB ultimately decided to delay any action on a prohibition until meetings scheduled for spring 2010. The primary reason cited for the delay in action on the recommended prohibition was a desire to “fully understand what impact may result from their recommendation.”

    The Organic Foods Production Act of 1990, part of the 1990 Farm Bill, authorized the Secretary of Agriculture to appoint a 15-member NOSB. The board’s main mission is to assist the Secretary in developing standards for substances to be used in organic production. The NOSB also advises the Secretary on other aspects of implementing the national organic program.
  • Significant New Use Rules (SNURs) have always been a valuable enforcement tool for the Environmental Protection Agency (EPA) and it looks like the Agency will be using them with increasing frequency for nanomaterials.

    Direct final SNURs published in the Federal Register on June 24, 2009 were withdrawn when the EPA received a notice of intent to submit adverse comments. The latest notice specifically identified two chemical substances already subject to premanufacture notices under the Toxic Substances Control Act (TSCA). The substances (PMN Number P08328 and PMN Number P08177) are single- and multi-walled carbon nanotubes.

    The substances were already subject to consent orders which required a 90-day inhalation toxicity study in rats (OECD 413) with a post-exposure observation period of up to 3 months, material characterization data and a limitation on production volumes and production time limits until testing is completed.

    Comments on the latest Federal Register Notice must be submitted by December 7, 2009.
  • Watching an Environmental Protection Agency (EPA) Scientific Advisory Panel (SAP) discuss potential risks associated with nanoscale silver is a stark reminder that there are no easy answers.

    Several non-governmental organizations and consumer groups consider the issue of nanomaterial safety to be a cut and dried issue. The frequent calls for bans on substances like nanoscale silver often neglect to consider the difference between hazard and risk. All that matters for many is that little scientific evidence exists which provides a clean bill of health for the products of nanotechnology.

    In May 2008 the International Center for Technology Assessment (CTA) led a coalition of consumer, health, and environmental groups to try to force the EPA to initiate a series of enforcement actions against companies producing consumer products using nanoscale silver as an antimicrobial agent.

    The coalition filed a petition calling for the agency to amend its regulations, or, at the very least, clarify that nanoscale silver is a pesticide and registration is required. In addition, the group is asking for appropriate labeling of the consumer products with nanoscale silver even if those products are not making antimicrobial claims.

    In going one step further, the coalition would like the EPA to classify all nano-pesticides as new pesticide substances which would trigger toxicity data requirements, testing, and risk assessments.

    The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) SAP public meetings last week provided a group of scientists with an opportunity to consider key aspects of the potential risks associated with nanosilver and other nanometal pesticide products.

    The discussions focused on four charge questions: 1) Do pesticide products containing nanosilver as the active ingredient pose potential hazards and exposures to humans and the environment that are different from those associated with products containing conventional silver?; 2) What type of data would EPA need to adequately assess the potential risks associated with the use of an antimicrobial pesticide containing nanosilver particles?; 3) Are there other risk assessment issues associated with nanoscale silver particles?; and 4) What research and information will be needed to improve the assessment of the potential risks on antimicrobial pesticide products containing nanoscale silver?

    SAP members were unable to establish a date of completion for its deliberations.
  • This workshop organized by the National Nanotechnology Initiative will facilitate effective communication about the state-of-the-art in the two overarching research need tracks: (1) Nanomaterials & Human Health; and (2) Instrumentation, Metrology & Analytical Methods. The workshop is free and will be held at the Holiday Inn Rosslyn at Key Bridge in Arlington Virginia on November 17 & 18, 2009.
  • The Interagency Nanotechnology Implications Grantees Workshop features presentations on recent research findings by U.S. Environmental Protection Agency (EPA), National Science Foundation (NSF), National Institutes of Health, National Institute of Environmental Health Sciences (NIH/NIEHS), National Institute for Occupational Safety and Health (NIOSH), and Department of Energy (DOE) grant researchers. The meeting will encourage collaboration and cooperation among nanotechnology grantees sponsored by EPA, NSF, NIEHS, NIOSH and DOE and between other federal grantees and federal nanotechnology researchers. Presentations and discussions will further the dialogue on appropriate nanotechnology research strategies. The meeting in Las Vegas on November 9-10, 2009 is open to members of academia, government, nongovernmental organizations, industry, and the general public.
  • Nanotechnology offers life-transforming benefits in areas such as personalized medical care, next generation cancer treatments, energy efficiency, innovative consumer products and water purification. What is it that is causing us to have a heightened sense of vulnerability about nanotechnology's ability to benefit society?

    Fourth in the popular Nanotechnology Today webinar series sponsored by NanoReg & Keller and Heckman, Product Liability and Nanotechnology will offer valuable perspectives and concrete recommendations from experienced companies and private litigators concerning product safety and what companies making or working with nanomaterials should be doing.
  • Seventeen debates in France are scheduled to provide the public with an opportunity to engage government officials on nanotechnology.

    The first debate organized by the Commission of Public Debates (CPDP) focused on the European regulation of nanotechnology, as well as looking at nanostructured materials. In October additional meetings will be held in Toulouse (life cycle of product containing nanomaterials) and Orleans (technology in the pharmaceutical and cosmetic sectors and protection of consumers).

    Each debate will have a specific regional theme but it is anticipated that any issues the public wishes to discuss will be considered. Additional meetings are planned in Bourdeaux, Clermont-Ferrand, Lille, Besancon, Grenoble, Caen, Metz, Rennes, Lyon, Marseille, Orsay, Montpollier and Nantes. The last debate is planned for Paris in February 2010 to address government ethics.

    According to president of the CPDP Jean Bergougnoux, the debate “must inform the public on the complex problems related to nanotechnology, allow the public to put forward their concerns and expectations, and make decision makers aware of their responsibilities.”

    Additional information on the debates can be found on the French-only Nano Public Debate website.
  • The question of how nanomaterials will be handled under the Registration, Evaluation, Authorisation and Registration of Chemicals (REACH) chemical management program will be the subject of a review by the European Commission (EC).

    In a speech at the Stakeholder Conference on Nanomaterials on the Market in Brussels, European Commissioner for the environment, Stavros Dimas, revealed the initiation of a concerted effort to review all of the recent chemical management laws in effect and their applicability to the products of nanotechnology.

    Acknowledging that nanomaterials are regulated under REACH in principle, Dimas also pointed out possible changes ahead for the regulatory framework to better allow for safety determinations. In terms of implementation of nano-specific regulations, the time frame seems fluid at best.

    “We will need to consider whether registration of the majority of nanomaterials will take place in 2010 or only at the end of the registration timetable in 2018 and if there are some nanomaterials that will not be registered under REACH. We will also need to look at other key provisions in REACH to see if they are adequate for nanomaterials,” Dimas said.

    The European Parliament passed a resolution earlier this year questioning whether REACH can adequately address the safety of nanomaterials despite the absence of any nano-specific regulations. The two-year evaluation of existing legislation is in response to the resolution.

    The only hint of specifics in terms of registration was the area of threshold volumes by Dimas. “One of the key elements in this balance was setting the volume threshold for registrations at 1 tonne – significantly higher than the old legislation which made notification of new substances mandatory from 10 kg. The important question to ask, and this is particularly relevant for nanomaterials, is whether what falls below the threshold may represent a risk to health and the environment. For standard chemicals the tonnage threshold is, I believe, appropriate, but the question is whether this is equally true for nanomaterials.”

    Dimas indicated there was no plan of action on how to get the information the Commission needs to fulfill its mission but insisted it “will review all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental or safety impacts over their life cycle.”
  • With the implementation of REACH in Europe and anticipated changes to the Toxic Substances Control Act (TSCA) in the U.S., the regulatory climate for producers and users of nanomaterials could become increasingly difficult and far more costly.

    Environmental Protection Agency (EPA) Administrator Lisa Jackson recently revealed a framework for TSCA (Toxic Substances Control Act) reform and announced plans to strengthen the Agency’s ability to address chemicals that could pose a risk to the public.

    For decades industry worked within the TSCA regulatory structure and many became comfortable with a framework that originally became law in 1976. The emergence of nanotechnology exposed the difficulty the Agency has in mandating the submission of the data needed for risk determinations in addition to challenging the very foundation of Agency enforcement capability by making new forms of existing substances that don’t fall neatly into the definitions of new or existing substances.

    While it was easy for the EPA to declare carbon nanotubes new substances, it was more difficult to address the prospective hazards of existing substances like titanium dioxide with regard to safety. These substances are already on the TSCA inventory and the data submission requirements generally are driven by determinations that there is a significant new use.

    It can be said that the EPA can always require data on new and existing substances but the existing regulatory procedures can make it difficult to do so in a timely manner. Ultimately, many products can enter the marketplace with little safety data being submitted to the Agency.

    Jackson’s speech to the Commonwealth Club of San Francisco in September did not specifically mention nanomaterials but a press release on the speech highlighted difficulties associated with the regulation of nanoscale materials.

    “An additional focus will be accelerating efforts to gather the critical information from industry that the agency needs to make chemical risk determinations. This will include filling the current gaps in health and safety data on high production volume chemicals; enhanced, transparent, and more current reporting of use and exposure information; and a number of requirements for increased reporting on nanoscale chemical materials. In addition, EPA is reviewing how nanoscale materials are managed under TSCA. EPA is also reviewing ways to increase the public’s access to information about chemicals.”

    For years some have feared even the slightest suggestion to change TSCA but most people in industry have come to recognize the inevitability of such a change and are, at least publicly, embracing the change.
  • It may just be a strategy but it goes a long way to answering vital questions regarding nanomaterial safety.

    In the final version of the Nanomaterial Research Strategy four basic areas have been identified to take advantage of existing Environmental Protection Agency (EPA) scientific expertise. These research themes include: Identifying sources, fate, transport, and exposure; Understanding human health and ecological effects to inform risk assessments and test methods; Developing risk assessment approaches; and Preventing and mitigating risks.

    The research program is intended to guide the EPA’s Office of Research and Development in nanomaterial research. The primary purpose of the program is to “conduct focused research to inform nanomaterial safety decisions that may be made under the various environmental statutes for which EPA is responsible.”

    Recognizing resource limitations, the ORD research is centered on seven manufactured nanomaterials: single- and multi-walled carbon nanotubes, fullerenes, cerium oxide, silver, titanium dioxide and zero-valent iron.

    The list of nanomaterials provided in the strategy is instructive. As part of the Organisation for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials, the U.S. and officials from 30 other government selected a list of 14 nanomaterials for which testing should be conducted. The U.S. Delegation is taking a leadership role in sponsoring or co-sponsoring OECD research on the 7 substances identified as the focus of this research strategy.

    Carbon black, aluminum oxide, zinc oxide, silicon dioxide, polystyrene, dendrimers and nanoclays were also identified by the OECD as important nanomaterials in commerce or likely to enter into commerce in the near term but are not part of the revised strategy.

    Another important aspect of the selected nanomaterials if the strategy’s acknowledgement that the data is intended for use in safety decisions by key EPA program offices including the Office of Pollution Prevention and Toxics, the Office of Pesticide Programs, and the Office of Air and Radiation. One could draw the conclusion that the 7 nanomaterials in the research strategy also represent the Agency’s highest priority in terms of regulatory and enforcement actions.
  • A great deal of funding for grants in several federal agencies has gone to research on nanotechnology implications and the Environmental Protection Agency (EPA) is providing an opportunity to see where some of that research is headed.

    The Agency previously held a grantee workshop and it was interesting to learn what researchers are discovering about the health and safety implications of nanomaterials. This workshop will showcase several research projects on nanoscale metals, carbon nanomaterials and other nanomaterials.

    Researchers have been funded by grants from several federal agencies including the EPA, National Science Foundation, National Institutes of Health/National Institute of Environmental Health and Safety, National Institute for Occupational Safety and Health and the Department of Energy.

    The workshop will be held November 9-10, 2009 in Las Vegas, Nevada at the Embassy Suites Hotel.
  • It has taken a while but the Environmental Protection Agency (EPA) is finally holding a public meeting on nanosilver and other nanometals products.

    In a Federal Register Notice on September 16, 2009 the Agency announced a meeting of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) on November 3-6, 2009. The SAP will “consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometals pesticide products.”

    According to the notice, the EPA’s Office of Pesticide Programs (OPP) has been approached by companies seeking product registrations to market products that contain nanosilver and/or other nanometals or nanometal oxides. “Based on OPP's understanding of the scientific literature, it appears that there may be potential for pesticides containing nanoscale materials to pose different risks to humans and the environment than those of pesticides that do not contain nanomaterials.”

    The EPA is also seeking nominations of qualified candidates for the SAP. Nominees may be added to the SAP in time for the November meetings. The consultation meeting will be held at the Environmental Protection Agency, Conference Center on S. Crystal Drive in Arlington, VA.
  • It doesn’t matter if it’s nano or not, if you make antimicrobial claims for a chemical substance the product must be registered as a pesticide.

    One of the most prevalent uses of nanomaterials is the use of nanoscale silver as an antibacterial and it has not gone unnoticed by federal regulators. In the latest Agency enforcement action it fined VF Corporation $1 million for making “unsubstantiated public health claims regarding unregistered products, and their ability to control germs and pathogens.”

    VF Corporation owns The North Face, a popular sportswear brand for outdoor apparel and gear. The EPA specifically cited more than 70 styles of footwear that incorporate an AgION silver treated footbed.

    The North Face made the following public health claims about the footwear on-line and on product packaging: AgION antimicrobial silver agent inhibits the growth of disease-causing bacteria; Prevents bacterial and fungal growth; and Continuous release of antimicrobial agents.

    This is not the first enforcement action taken by the Agency for nanoscale silver. Last year fines were levied against ATEN Technology of Irvine, California for selling unregistered pesticides and making unproven claims about their effectiveness for a wireless laser mouse, laser travel mouse, and wireless keyboard using nanoscale silver. The company reached a settlement with the EPA to pay a fine of $208,000.
  • The issues surrounding the labeling of organic foods are getting even more complex with nanotechnology entering the picture.

    The U.S. Department of Agriculture’s (USDA) National Organic Standards Board (NOSB) announced in a Federal Register Notice public meetings November 3-5, 2009 to address a variety of issues but the key issue at hand for the nanotechnology community is the proposed prohibition of all things nano. The proposed prohibition would exclude all nanomaterials from the food itself in addition to food packaging that may come into contact with organic food.

    NOSB committees will present recommendations on changes in the current standards to clarify the definitions of the National List of Allowed and Prohibited Substances; to prohibit nanotechnology in organic production, processing, and packaging; to clarify the labeling and enforcement of organic cosmetics in the marketplace; and to strengthen animal welfare practices for livestock and poultry.

    The National List of Allowed and Prohibited Substances identifies synthetic substances that may be used, and the nonsynthetic substances that cannot be used, in organic production and handling operations.

    The meetings will be held at the Washington Plaza Hotel in Washington, DC.
  • In an effort to gain insight from a broad range of stakeholders, the California Department of Toxic Substances Control (DTSC) is holding another nanotechnology symposium. This time, industry is playing a key role in the public event.

    Jeff Wong, Chief Scientist for the DTSC, had been seeking a way to reach out to producers and users of nanomaterials so the agency could gain a better understanding of the environmental and health implications of nanomaterials. Representatives from a network of producers and users have developed a symposium program to highlight existing knowledge on nanomaterials and ongoing collaborations between industry, government and academia to continue research on the safe development and use of nanoscale materials.

    Jeff Wong and DuPont’s Tom Jacobs will make opening remarks and Ann Grimaldi of McKenna Long & Aldrich will provide a background to the DTSC data call-in efforts and commentary on the symposium program.

    The first session of the symposium will feature Dr. Andrew Maynard, Chief Science Advisor to the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars as moderator. Dr. Maynard’s overview of emerging nanomaterials and related safety, health and environmental issues will be followed with presentations by several international experts that will focus on collaborative efforts.

    The experts for the opening session include: Dr. Kristen Kulinowski, Director for External Affairs for the Center for Biological and Environmental Nanotechnology (CBEN) and Director of the International Council on Nanotechnology (ICON); Dr. Charles Geraci, Coordinator of the NIOSH Nanotechnology Research Center; Dr. Richard Pleus, Intertox Managing Director and toxicologist; and Terry Medley, DuPont Director of Global and Corporate Regulatory Affairs and Co-Chair of the USCIB Nanotechnology Committee.

    The afternoon session includes industry presentations by: Amy Jones, Lockheed Martin; Ray David, BASF; Steve Brown, Intel; and Bob Hamilton, Amway. Both sessions will be followed with panel discussions moderated by Dr. Maynard and will include Tim Malloy, professor at the UCLA School of Law and Patricia Holden of the Bren School of Environmental Science & Management at UCSB.

    Members of the industry network expressed a desire to show they understand the challenges of developing and using safe nanomaterials and they are already engaged in constructive and collaborative efforts to respond to those challenges. The symposium is expected to show that industry is working with a broad range of government and research organizations globally and that it is applying evolving knowledge to systematically address areas of concern.

    The symposium, fifth in a series sponsored by DTSC, will be held in the Cal/EPA Byron Sher Auditorium in Sacramento, CA on November 16, 2009.
  • A case study of nanoscale titanium dioxide in water treatment applications and sunscreen looks at environmental and health implications. Your comments are welcome.

    On July 31, 2009 the Environmental Protection Agency (EPA) announced a 45-day comment period for the case study in a Federal Register Notice. The document, Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and Topical Sunscreen, was prepared by the National Center for Environmental Assessment within EPA's Office of Research and Development.

    The report makes it clear that it is a work in progress and there is a great deal of information needed to fully assess the impact of nanomaterials. According to the notice, “These ‘case studies’ do not represent completed or even preliminary assessments; rather, they present the structure for identifying and prioritizing research needed to support future assessments. The case studies follow the comprehensive environmental assessment (CEA) approach, which combines a product life-cycle framework with the risk assessment paradigm.”

    Only two nanoscale titanium dioxide applications are the subject of the case study: Arsenic removal from drinking water and as an active ingredient in topical sunscreen. It would appear that these two applications were chosen both for their similarities as well as their differences. The report indicates that taking this approach would allow a broader review of other nanomaterials which can be used in multiple applications.

    The case study is not intended to be used specifically set regulatory standards but it clearly indicates that “the intent is to use this document in developing the scientific and technical information needed for future assessment efforts as input to policy and regulatory decision-making.”
  • Two new reports in the Organisation for Economic Co-operation and Development (OECD) Series on the Safety of Manufactured Nanomaterials reflect progress on determining the applicability of existing test guidelines for nanomaterials.

    The Guidance Manual for the Testing of Manufactured Nanomaterials: OECD Sponsorship Programme (2009) addresses the Sponsorship Programme of the list of fourteen manufactured nanomaterials to be tested by a specific group of country sponsors. The document describes the program and details the endpoints for testing of the specified nanomaterials.

    To determine the applicability of existing OECD test guidelines, a group of working party members developed a Preliminary Review of OECD Test Guidelines for their Applicability to Manufactured Nanomaterials (2009). Toxicity endpoints are identified and a preliminary determination is made on each appropriate test guideline prior to the initiation of testing of nanomaterials under the Sponsorship Programme.

    Very few of the reviewed guidelines were determined to be applicable without modification. According to the document, “Many of the OECD Test Guidelines are applicable, with conditions in some cases, while some are inadequate for testing Manufactured Nanomaterials (MN) as measuring, dosing, delivery and tracking nanomaterials are not reliably accomplished at this stage. Therefore, the review of OECD Test Guidelines reinforced the need for a guidance document(s) for sample preparation and dosimetry. It suggests that the guidance document(s) be developed as a new document(s), and be independent from the existing OECD guidance documents.”
  • To no one’s surprise, the Environmental Protection Agency intends to issue a mandatory rule to collect data on nanoscale materials according to a report by the Agency’s independent advisory committee.

    The Sixty-Fourth Report of the Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) to the Administrator of the Environmental Protection Agency was released in a Federal Register Notice on August 4, 2009.

    Based on a review of the EPA’s interim report on the Nanoscale Materials Stewardship Program, the Agency “intends to develop a proposed Toxic Substances Control Act section 8(a) rule to obtain information on the production, uses, and exposures of existing nanoscale materials.” Section 8(a) of TSCA allows the Agency to issue a rule for mandatory submission of a broad range of data.

    Virtually every aspect of nanomaterial characterization, hazards and exposure are subject to any such rule. Materials of interest to the ITC include: fullerenes; carbon black, titanium oxide nanowires, titanium oxide nanoparticles; zinc oxide; nanosilver; silica; quartz; cerium oxide; indium tin oxide; dendrimers; single–walled carbon nanotubes; multi–walled carbon nanotubes; carbon nanofibers; quantum dots; nanoceramic particles; and nanoclays.
  • Anticipating the receipt of adverse comments has led the Environmental Protection Agency (EPA) to withdraw the final significant new use rules (SNURs) for carbon nanotubes (CNTs).

    In a Federal Register notice on August 21, 2009 the EPA indicated it had received a notice of intent to submit adverse comments and was withdrawing the SNURs issued on June 24, 2009. Affecting multi-walled carbon nanotubes and single-walled carbon nanotubes, the SNURs were issued under an expedited rulemaking process but the Agency will now be forced to propose SNURs under separate notice and comment rulemaking procedures.

    The procedure originally used by the EPA is one in which no adverse comments are anticipated and the ruling is expected to be noncontroversial.

    The Agency did not indicate the source of the submission forcing the withdrawal but a review of the docket (EPA-HQ-OPPT-2008-0252) reveals a letter from James Votaw of WilmerHale indicating that “comments will be submitted respecting SNURs for PMN Numbers P-08-177 and P-08-328.”

    Further review of the EPA docket indicates the two Premanufacture Notices were submitted by Swan Chemical for its Elicarb line of carbon nanotubes.

    In a rather insightful discussion of the SNUR withdrawal by EDF Senior Scientist Richard Denison, Mr. Votaw responds with a clarification of the intent of his submission. “The contemplated SNUR will only be deferred for a time while EPA receives public comment on a narrow possible range of issues.” He also indicated the primary concern is that, in using generic descriptions, the Agency did not specify which carbon nanotubes are affected. “If the SNUR is issued correctly, we’ll all know upfront which particular CNTs are, or are not, covered by this SNUR, and without any lengthy regulatory application process (available only to manufacturers).”
  • The death of two women in China working with a cocktail of chemicals which included nanoparticles was the subject of a clinical study that has ratcheted up concerns over nanotechnology safety.

    The study, Exposure to nanoparticles is related to pleural effusion, pulmonary fibrosis and granuloma, was recently published in the European Respiratory Journal. The study confirmed that a total of seven women were exposed over a period of 5 to 13 months and were admitted to the hospital with shortness of breath and liquid effusion around the heart and lungs.

    Polyacrylate nanoparticles were confirmed in the workplace and, using transmission electron microscopy, nanoparticles were observed to lodge in the cytoplasm and caryoplasm of pulmonary epithelial and mesothelial cells, but were also located in the chest fluid.

    Authors of the study indicate “these cases arouse concern that long-term exposure to some nanoparticles without protective measures may be related to serious damage to human lungs.”

    The lead scientist, Yuguo Song, believes the nanoparticles were inhaled by the women who daily used polyacrylate-based adhesive paints. Precise measures on the level of exposure could not be obtained because the workshop was closed down several months before the investigation and the paint in question could not be identified.

    Reaction to publication of this study has been expectedly swift. A particularly helpful review of the study was undertaken by Dr. Andrew Maynard, Chief Science Adviser at the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies.

    In his 2020 Science blog Dr. Maynard solicited opinions on the study by several noted experts familiar with nanomaterials safety. Dr. Kristen Kulinowski, Director of the International Council on Nanotechnology (ICON) at Rice University lamented the lack of a more detailed analysis of the nanoparticles and a need for more information on how they were produced.

    Reflecting the views of other experts on the study, Dr. Kulinowski said “the real tragedy here is that these workers could have been protected if a conventional chemical hygiene plan had been implemented that included a working ventilation system and personal protective equipment. Preventing inhalation of 30-nm nanoparticles can be as simple as the proper use of an inexpensive mask sold by your neighborhood home improvement store. But even this basic protective measure was not employed in this workplace.”

    Dr. Rob Aitken, Director of Strategic Consulting at the Institute of Occupational Medicine in Edinburgh and director of the SAFENANO initiative, highlighted one of the difficulties in drawing any conclusions from the study.

    “The key question which remains unanswered at this time is “exposure to what?” The exposure assessment in the study is poorly described. It seems from the information provided that these unfortunate workers were handling a paste composed of a complex mixture including butanoic acid, butyl ester, N-butyl ether, acetic acid, toluene, di-tert-butyl peroxide, 1-butanol, acetic acid ethenyl ester, isopropyl alcohol and ethylene dioxide and finally some type of nanoparticle, 30 nm in diameter. Although the authors describe the nanoparticles found as being polyacrylate, the characterisation within the study provides no clear information about either the nanoparticles’ composition or their quantity within the paint paste.”

    Professor Vicki Stone, Editor of the journal Nanotoxicology, suggested “the publication contains a number of flaws, which make this conclusion hard to believe or confirm.”

    The “father” of research into the toxicology of inhaled nanoparticles, Professor Günter Oberdörster said “To blame the resulting severe pathology and fatalities categorically on ‘nanoparticles’ that were present in a paint paste is scientifically unjustified.”

    Professor Ken Donaldson, a toxicologist specializing in workplace lung diseases, and Professor Anthony Seaton MD, a distinguished clinical physician specializing in occupational health and a highly regarded expert on the potential impacts of inhaling airborne nanoparticles, came to similar conclusions.

    Despite the precautionary opinions of these experts the public will continue to conclude that nanotechnology is an uncertain science with adverse impacts yet to be discovered. Blaring headlines that link nanoparticles to the occupational exposure-related deaths will do little to allow a rationale discussion of nanomaterial safety and will only stoke the fires of some who wish to draw attention to their cause with little regard for sound science.
  • Following a well-attended workshop in February on Human and Environmental Exposure Assessment, the National Nanotechnology Initiative (NNI) has scheduled a second workshop.

    The next workshop in the nanoEHS series, Nanomaterials and the Environment & Instrumentation, Metrology, and Analytical Methods, will discuss on-going research and attempt to identify priority gaps and emerging trends. Another goal of the workshop will be to discuss the progress of research as it relates to the NNI’s EHS research strategy.

    The workshop will be held at the Holiday Inn Key Bridge in Arlington, Virginia October 6-7, 2009. Additional workshops are scheduled for November 2009 and March 2010.
  • The National Institute for Occupational Safety and Health (NIOSH) been a leader on nanomaterial safety in occupational settings and it has scheduled another conference on the topic.

    The conference is planned to “identify gaps in information and address questions focusing on occupational health surveillance, exposure registries, and epidemiologic research involving nanotechnology workers,” according to a recent announcement.

    Scheduled for a location in Colorado in July 2010, the conference will: Share existing knowledge; Identify major issues; Examine successful approaches; and Explore new approaches, techniques, and models.
  • Nanomaterials have long promised to help solve environmental contamination problems and a new map can show you where this is already happening.

    In an article published in Environmental Health Perspectives, authors Barbra Karn (U.S. EPA), Todd Kuiken and Martha Otto (both of the Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies) evaluated the application of nanomaterials for remediation at 45 sites globally. The evaluation used only a fraction of the total sites being remediated with nanomaterials but they were able to compile a list of nanomaterials in use, the type of pollutants cleaned up and identification of the entities responsible for the remediation.

    To coincide with publication of Nanotechnology and In situ Remediation: A review of the benefits and potential risks the Project on Emerging Nanotechnologies developed an interactive map which includes oil fields, manufacturing sites, military installations, private properties and residences.

    The map depicts the location of the evaluated sites and the nanomaterials used in the remediation. Most of the sites are polluted with pesticides or organic solvents such as PCE and TCE. The nanomaterial of choice for many of the sites is some form of zero-valent iron.
  • One of the harshest critics of industry on the issue of nanomaterial safety came to an interesting conclusion – sunscreens containing nanomaterials are safe!

    Very few organizations have been more vocal than the Environmental Working Group (EWG) about the dangers of nanomaterials in consumer products. However, in a rather thorough review of sunscreens and studies of nanoparticle penetration into skin the group concluded that the benefits of nanomaterials in sunscreens outweigh the possible hazards.

    The 2009 Sunscreen Investigation evaluated sunscreens containing nanoscale titanium dioxide and zinc oxide in addition to nano-free products. According to the report, “When we began our sunscreen investigation at the Environmental Working Group, our researchers thought we would ultimately recommend against micronized and nano-sized zinc oxide and titanium dioxide sunscreens.”

    The investigation evaluated nearly 400 peer-reviewed studies on nanomaterials in sunscreens. The study “shows that consumers who use sunscreens without zinc and titanium are likely exposed to more UV radiation and greater numbers of hazardous ingredients than consumers relying on zinc and titanium products for sun protection.”

    Noteworthy in this report is the divergence of thought on previous portrayals of nanomaterials in sunscreens by EWG. Now that there is scientific data showing little risk of exposure to nanomaterials through the skin, EWG is acknowledging the benefits of nanoscale metal oxides in sunscreens.

    “On balance, EWG researchers found that zinc and titanium-based formulations are among the safest, most effective sunscreens on the market based on available evidence. The easy way out of the nano debate would be to steer people clear of zinc and titanium sunscreens with a call for more data. In the process such a position would implicitly recommend sunscreen ingredients that don't work, that break down soon after they are applied, that offer only marginal UVA protection, or that absorb through the skin.”

    Kudos to EWG. Like many others they appropriately sounded the alarm on nanotechnology with calls for additional data to make sure we understand what we’re dealing with. EWG took the initiative to examine the science and reach a valid conclusion. While this in no way validates all nanomaterials as safe it is an excellent example of using the science rather than emotions to reach a conclusion on a technology that has so many benefits.
  • The Organisation for Economic Co-operation and Development’s (OECD) Working Party on Manufactured Nanomaterials (WPMN) is the most broadly-based inter-government collaboration focused on nanomaterial safety and regulatory policy. As part of the Series of Safety of Manufactured Nanomaterials, the organization released three guidance documents with a focus on exposures and protection.

    Document Number 11, Emission Assessment for the Identification of Sources and Release of Airborne Manufactured Nanomaterials in the Workplace: Compilation of Existing Guidance is the result of a project conducted by the U.S. National Institute for Occupational Safety and Health (NIOSH) field team. It is intended to provide guidance for health and safety professionals, specifically for industrial/occupational hygienists.

    Steering Group 8 of the WPMN is charged with leading the work on Co-operation on Exposure Measurement and Exposure Mitigation. The operational plan contained three phases of work: 1) exposure in occupational settings; 2) exposure to humans resulting from contact with consumer products and environmental releases of manufactured nanomaterials; and 3) exposure to environmental species resulting from environmental releases of manufactured nanomaterials including releases from consumer products containing manufactured nanomaterials.

    The objectives of phase 1 are described as: 1) To identify and compile guidance information for exposure measurement and exposure mitigation for manufactured nanomaterials in occupational settings, including manufacture and use of products in industrial, institutional and commercial settings; and 2) To analyze existing guidance information for their adequacy in addressing manufactured nanomaterials, identify issues that are unique to manufactured nanomaterials, and prepare recommendations for next steps to be undertaken by the WPMN.

    As part of Phase 1, the WPMN developed Document 12, Comparison of Guidance on Selection of Skin Protective Equipment and Respirators for Nanotechnology Workplaces: Manufactured Nanomaterials. This document compares guidance on personal protective clothing, gloves and respirators, including a compilation of efficacy of personal protective equipment, especially respirator cartridges and gloves. Thus, it provides an overview for experienced health and safety professionals and is to be seen as one element in limiting worker exposure.

    Document 13, Report of an OECD Workshop on Exposure Assessment and Exposure Mitigation: Manufactured Nanomaterials, is a report on presentations given at a workshop in Frankfurt Germany in October 2008.
  • A recent Federal Notice involving Significant New Use Rules (SNURs) caused some confusion and the Environmental Protection Agency (EPA) has taken the opportunity to clarify its position.

    In a statement released July 29, 2009 by EPA’s David Giamporcaro, the Agency specifically addressed the applicability of the SNURs listed in the June 24, 2009 Federal Register Notice. “Upon reviewing the rules some stakeholders have asked EPA whether these SNURs apply to all variants of carbon nanotubes. This is not the case. These SNURs only apply to the specific carbon nanotubes that were the subject of the premanufacture notices (PMNs) submitted under Section 5 of TSCA and not to any other carbon nanotubes. Other carbon nanotubes must be notified through EPA's New Chemicals Program. The U.S. EPA strongly encourages all manufacturers and importers of nanoscale materials that are intended for commercial use to consult with the Agency in advance of production or importation.”
  • Despite hype about nanotechnology as an emerging technology, a great deal of knowledge has already been developed on workplace safety and the handling of nanomaterials. With the International Council on Nanotechnology’s (ICON) new information-sharing tool, the GoodNanoGuide, we may come to realize that much more information is available that we previously believed.

    ICON fostered development of the GoodNanoGuide as a practical tool for people who handle nanomaterials as well as a dynamic, online repository of safety protocols. The open-source wiki is governed by an implementation committee from North America and Europe.

    Experts from the worlds of nanotechnology, occupational safety and business contributed to the development of the guide which is freely available at GoodNanoGuide.org.

    “Governmental agencies and occupational researchers are generating a lot of good information about how to handle nanomaterials safely,” said ICON Director Kristen Kulinowski, a faculty fellow in chemistry at Rice and executive director of the Center for Biological and Environmental Nanotechnology. “The GoodNanoGuide points to and supplements these resources with specific protocols that can be used by workers in any setting where they are being handled.”

    Financial support for the development of the GoodNanoGuide beta site was provided by ICON, nanoAlberta, British Columbia Nanotechnology Alliance-Nanotech BC, Industry Canada, Institut de recherche Robert-Sauvé en santé et en sécurité du travail and NanoQuebec.
  • Sometimes a word is just a word but discussions at the latest ISO TC 229 meetings on nanotechnology reflect the challenge of creating standards that can have enormous commercial and regulatory implications.

    What is the definition of nanomaterial or nanomanufacturing? For some people the answers are simple but when more than 170 experts from 23 countries gathered in Seattle to further address these terms the discussions revealed a complex set of issues.

    It’s certainly important for producers and users to have commonly accepted terminology to facilitate manufacturing operations, purchasing of nanoscale materials and establishment of terms that characterize nanomaterials. Also of tremendous importance is the use of accepted standards by regulatory officials. Government officials traditionally look to accepted standards as guideposts when establishing regulatory requirements.

    One simple example is illustrative of the potentially enormous impact of accepted definitions. Most discussions of nanomaterials begins with a description of nanomaterials that are 100 nanometers or smaller in any single dimension. While there are many discussions to be held before formal adoption of this standard takes place, how many more nanomaterials would fall under regulatory requirements if the accepted standard were to be 200 or 300 nanometers in any single dimension?

    At first glance it would appear to be a useless discussion of semantics but the words used to develop definitions and standards for nanotechnology can have enormous commercial and regulatory implications. Observers at the numerous working group meetings noted the “deliberative” pace of the discussions yet the discussions reveal a tangled web of preferences for standards that revolve around existing terminology and manufacturing operations.

    Active working groups in Seattle included: Terminology and Nomenclature; Measurement and Characterization; Health, Safety and Environmental Aspects of Nanotechnologies; Material Specification; Nanotechnology & Sustainability; and Measurement & Characterization for EHS.

    While some definitions and standards have been completed it will be some time before all of the issues can be resolved.

    The International Organization for Standardization (ISO) Technical Committee (TC) 229, Nanotechnologies, is administered by the American National Standards Institute (ANSI).
  • Carbon nanotubes, the subject of a recent data call-in, are only the first nanomaterials that the California Department of Toxic Substances Control (DTSC) is interested in. As expected, the list of nanomaterials of interest has begun to grow.

    The DTSC web site has been updated to broaden the nanomaterials of interest to include several substances. The update identified the additional nanomaterials as part of a request for information “regarding analytical test methods, fate and transport in the environment, and other relevant information from manufacturers of reactive nanometal oxides.”

    In addition to requesting information on nanoscale metal oxides (aluminum oxide, silicon dioxide, titanium dioxide, and zinc oxide), the DTSC took the opportunity to add nanoscale silver, zerovalent iron and cerium oxide to its list of nanomaterials of interest. Generally an announcement of this type is the first in a series of steps taken by the DTSC to gather scientific information for use in establishing regulatory regimes for chemical substances.

    While not a formal information request, the announcement was made in the hope that producers and users would voluntarily submit information on the listed nanomaterials.

    Some of the information requested was provided to the EPA’s Nanoscale Materials Stewardship Program, but much of it was submitted with a request for confidentiality. While this may have helped producers meet the needs of the NMSP it makes it difficult to make the information publicly available or to share it with other regulatory authorities who may benefit from the submission.

    The NanoReg Report has learned that DTSC officials have initiated steps to determine if it can establish a system to allow companies to submit sensitive data on substances with some guarantee of confidentiality to protect intellectual property and marketing information.
  • As expected, the Environmental Protection Agency (EPA) is stepping up regulatory enforcement of the Toxic Substances Control Act (TSCA) for nanomaterials.

    In a Federal Register notice on June 24, 2009 the Agency issued a direct final rule making a significant new use determination for 23 substances which were the subject of premanufacture notices (PMNs). The list includes single- and multi-walled carbon nanotubes.

    This is the latest in a series of actions taken by the agency in an attempt to gather scientific data on the safety of nanomaterials. The Nanoscale Materials Stewardship Program initiated the information gathering but officials were openly disappointed in the number of submissions under the program.

    Despite satisfaction with participation in the Basic program, agency officials expressed disappointment over the level of participation in the In-Depth Program which would allow participants to work with EPA to develop new data on representative nanoscale materials over a much longer time frame that the original 6 months for the Basic Program. Only 4 companies agreed to participate in the In-Depth Program and sources indicate their participation was something less than voluntary.

    Last fall the EPA made available to the public a “sanitized” Consent Order which has been routinely attached to PMNs for multi-walled carbon nanotubes. The order requires submitters to take several actions including conducting a 90-day inhalation toxicity study in rats.

    In October and November 2008 the EPA took related actions with two Federal Register notices. One was a Significant New Use Rule (SNUR) for siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles. The other notice clarified the regulatory status of carbon nanotubes by declaring them to be a "new substance" when it comes to TSCA. The notice states that "EPA generally considers CNTs to be chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA Inventory."

    Last month the Agency published a Federal Register notice specifically targeting carbon nanotubes for future data collection activities which will inevitably include a test rule. The notice indicated “a TSCA section 4(a) test rule may be needed to determine the health effects of multiwall carbon nanotubes.”

    This notice is almost certainly a prelude to a test rule given the regulatory climate under the new administration.

    Unless adverse or critical comments are submitted to the Agency prior to August 24, 2009 the rule will go into effect on that date. However, significant new use designations for these substances are legally established as of June 24, 2009.
  • Managing nanomaterials for commercial distribution is about good product stewardship, good information management, and good risk management. Manufacturers of nanomaterials need to understand their characteristics and the available research on them in order to be able to distinguish between sound science and purported science. The webinar, Nanotechnology in the Marketplace, is the second in a series sponsored by NanoReg & Keller and Heckman. The webinar will summarize the state of knowledge and provide information and recommendations for takeover and control of risks in order to prevent the occurrence of accidents or the development of occupational diseases.

    Two seasoned nanotechnology professionals, Mark Banash, Ph.D., of Nanocomp Technologies and Richard C. Pleus, Ph.D., of Intertox will make presentations in this webinar.

    Mark Banash, Ph.D., of Nanocomp Technologies will present Developing Workplace Monitoring and Exposure Controls at a Carbon Nanotube Manufacturer. In this talk Dr. Banash will present both a review and an evaluation of available equipment and techniques and how their results have helped design, modify, and verify his company's operating procedures, engineering controls, and choices in personal protective equipment.

    Richard C. Pleus, Ph.D., of Intertox will present Steps to Address EHS Concerns that Businesses Should Consider Before Placing Nanomaterials on the Market. Dr. Pleus explores possible EHS concerns in relation to what business needs in order to minimize their business risk, while protecting the health and safety of their workers and the public.
  • Apparently, changes to the Toxic Substances Control Act (TSCA) and the Environmental Protection Agency (EPA), won’t suffice. While this approach seemed feasible a few years ago, it now seems that the only way to effectively regulate nanotechnology is through a whole new bureaucracy.

    Former EPA Assistant Administrator for Policy, Planning and Evaluation J. Clarence (Terry) Davies must have had second thoughts about the ability of his former employer to regulate nanotechnology even though the Agency implemented some of the proposed actions in his May 2007 report, EPA and Nanotechnology: Oversight for the 21st Century.

    The new report, Oversight of Next Generation of Nanotechnology, takes a somewhat different approach. Rather than suggesting a fix to existing laws and federal agencies Davies thinks a new agency combining the Environmental Protection Agency, the U.S. Geological Survey (USGS), the National Oceanic and Atmospheric Administration (NOAA), the Occupational Safety and Health Administration (OSHA), the National Institute of Occupational Safety and Health (NIOSH) and the Consumer Product Safety Commission (Consumer Product Safety Commission).

    Combining all of these agencies is supposed to “improve the government’s ability to handle almost all major environmental and consumer programs.” All of the changes proposed by Davies are intended to bring greater efficiency and effectiveness in the ability of the federal government to establish an oversight policy in several environmental and regulatory areas which may ultimately improve public safety.

    In the report Davies does an excellent job describing the requirements of an effective oversight system. The difficulties associated with assessing risks of nanomaterials and understanding the specific characteristics impacting adverse effects are excellent examples of the complexity of the safety discussion.

    There is one glaring omission in the report that seriously impacts his argument for a new agency. By his own admission, “It is unlikely that government agencies will improve their efficiency, speed and expertise sufficiently to keep pace with technological innovation.” If that is the case, how will a new agency be any different? What is it about the proposed new federal Department of Environmental and Consumer Protection that will be able to assess the risks of new technologies without inhibiting innovation?

    The continued criticism of the EPA is not the sole domain of Davies. The Agency has been the subject of complaints on how it handles any nanotechnology for some time. In previous PEN reports and several other sources, TSCA is often highlighted as an inadequate statute that is not effectively administered by EPA officials.

    The Consumer Product Safety Commission is also chastised in the report and the Food and Drug Administration is rightfully criticized for its failure to oversee cosmetics and dietary supplements for failing to adequately monitor and regulate products containing nanomaterials.

    Changes are in the wind at EPA with the Toxic Substances Control Act in the crosshairs of many but the report fails to draw a straight line from today’s regulatory shortcomings to creation of a new federal agency which will more efficiently evaluate risk and oversee the development of nanotechnology.
  • Developing a global strategy to assess and manage chemicals is no easy task. Complex issues related to producing and using chemicals safely are difficult to resolve and emerging technologies are making it even more difficult.

    Nanotechnology, chemicals in products, electronic waste and lead in paint have been identified as emerging policy issues at the second session of the International Conference on Chemicals Management (ICCM). SAICM, the Strategic Approach to International Chemicals Management, a policy framework to foster the sound management of chemicals, was adopted by the first session of the ICCM on February 6, 2006 in Dubai, United Arab Emirates.

    Sensing a lack of progress on the issue of nanotechnology safety, activist groups expressed disappointment. ETC Group’s Diana Bronson said “We are a long way from the statement that was adopted less than a year ago at the meeting organized by the International Forum on Chemical Safety in Dakar. There, governments, industry, trade unions and non-governmental organizations had agreed that the precautionary principle needed to be applied, that countries should have the right to say no to nanotechnology and that special measures need to be taken to protect vulnerable groups. We got none of that in Geneva.”

    Judith Carreras from Sustainlabour, part of the trade union delegation, also expressed her disappointment that a stronger statement had not been achieved on occupational health and safety issues related to nanotechnology. “We barely got a mention of workers in the document, yet they are on the front lines of exposure to nanomaterials at the workplace [research, manufacturing, packaging, etc.]. In many cases, workers do not even know they are working with nanoparticles, let alone at risk of any harmful effects. It is urgent that this question receives more attention and we are disappointed that some delegations fought against stronger provisions.”

    This is one of the first major discussions of nanomaterial safety at this forum and more is anticipated at future meetings with the next ICCM scheduled for 2012. SAICM is a community of partners, comprising stakeholders from governments, intergovernmental organizations and civil society, including the private sector, working towards sound chemicals management by 2020.
  • Safety is an important consideration when working with any chemical substance but difficulty in regulating safety is leading to the next best thing – labeling of consumer products to inform the public when commercial goods contain nanomaterials.

    The latest action by the New South Wales Government in Australia disappointed those who have pushed for labels on consumer products containing nanomaterials. Taking a more cautious approach, the government will review the need for label on sunscreens, food and cosmetics containing nanoparticles.

    Like their counterparts in the U.S. and Europe, the New South Wales Government declined to classify all nanomaterials as new chemicals. In Australia such a designation would require an assessment of the nanomaterial’s safety prior to their use in consumer products.

    In Europe there is a great deal of political pressure for mandatory labeling. Nanomaterials in food, food packaging and cosmetics have led the European Parliament to consider labeling of these products. All ingredients present in the form of nanomaterials may need to be clearly indicated in the list of ingredients with the names of the ingredients followed by the word 'nano' in brackets.

    Australian labor unions have been pressing for nano-specific regulations. In April the Australian Council of Trade Unions called for the regulation of nanomaterials as new chemical substances, new standards for the handling of nanomaterials and a requirement that all commercial products containing nanomaterials be labeled.

    While most regulatory officials around the globe are taking steps to ensure regulatory frameworks are based on sound science, those unhappy with the slow pace have found that pushing the regulatory boundaries can be much easier by using the labeling approach as a consumer safety measure.

    When it comes to the public it is much easier to grab hold of the emotional issue and frame it as just information so consumers can make an informed decision. The net effect, however, is to give pause to consumers who may have heard that nano is bad and they want no part of it.
  • If ever there was a time for carbon nanotube producers or importers to belong to a consortium now is the time as the Environmental Protection Agency (EPA) gears up for a section 4(a) test rule.

    The last NanoReg Report discussed comments made by EPA officials that indicated steps were being taken to broaden enforcement activity for nanomaterials. Now the Agency has published a Federal Register notice which specifically targets carbon nanotubes for future data collection activities which will inevitably include a test rule.

    In the Nanoscale Materials Stewardship Program the Agency collected a great deal of information on occupational exposure mitigation practices but did not get very much information on the potential hazardous properties associated with carbon nanotubes. The notice indicates a “TSCA (Toxic Substances Control Act) section 4(a) test rule may be needed to determine the health effects of multiwall carbon nanotubes.”

    Since last fall the EPA has attached a Consent Order to all Premanufacture Notices (PMNs) for multiwalled carbon nanotubes. The order requires nanotube PMN submitters to take several actions including conducting a 90-day inhalation study in rats.

    While no specific dates have been established for implementation of the test rule, it is the latest in a series of actions taken by regulatory agencies and other standard-setting agencies to identify the health effects associated with carbon nanotubes. Canada is on the verge of a data call-in, the State of California has already issued a mandatory data call-in and the National Institute for Occupational Safety and Health (NIOSH) has also requested additional data which could be used to develop workplace safety standards.
  • The latest report in a series from the Organisation for Economic Co-operation and Development (OECD) examining the safety of nanomaterials focuses on exposure measurement and exposure mitigation.

    Endorsed by the Working Party on Manufactured Nanomaterials, the document is the result of one of the group’s main areas of work to further develop appropriate methods and strategies to help ensure human health and environmental safety.

    In the area of exposure monitoring several key findings are revealed: There are no commercially available personal samplers designed to measure the particle number, surface area, or mass concentration of nanoaerosols; There have been few developments reported on techniques to discriminate between engineered and incidental airborne; Sampling and analytical methods developed for assessing dermal exposures to chemicals have not been evaluated for their applicability to characterize dermal exposures to nanomaterials; and There is no agreement on the metrics of exposure to nanomaterials.

    Several recommendations are provided which all point to the need to gather additional information on the appropriate metrics of exposure, measurement techniques, and sampling protocols.

    Exposure mitigation issues would appear to represent additional challenges since the report acknowledges there is “limited knowledge about the hazardous properties of nanomaterials and exposure levels in the workplace.”

    The Preliminary Analysis of Exposure Measurement and Exposure Mitigation in Occupational Settings: Manufactured Nanomaterials is the latest in an OECD Series on the Safety of Manufactured Nanomaterials.
  • In recognition of the importance of the issue of safety of nanotechnologies, the European Commission (EC) is organizing a one-day scientific hearing.

    In announcing the consultation the EC noted two recent opinions of scientific experts indicating a need for additional data to address the potential risks associated with nanomaterials. The recent opinion on the Risk Assessment of Products of Nanomaterials by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) found that the methodologies for assessing exposure to manufactured nanomaterials to humans and the environment, as well as the identification of potential hazards require further development.

    The Scientific Committee on Consumer Products (SCCP), now replaced by the Scientific Committee on Consumer Safety (SCCS), also contributed to the discussions with its Opinion on Safety of Nanomaterials in Cosmetic Products that expressed concerns about the lack of information on nanomaterial hazard identification, exposure assessment, uptake, the role of physico-chemical parameters of nanoparticles determining absorption and transport across membranes in the gut and lungs, and other possible health effects.

    With so many experts indicating a need for additional information, the Commission will hold a one-day scientific hearing which will take place on September 10, 2009 in Brussels. The hearing will focus on the scientific aspects of the issues covered in the Scientific Committees' opinions related to nanotechnology.

    The consultation has three main objectives: Identification of any possible topics which have not been covered in the opinions from the relevant EU Risk Assessment Committees and Bodies; Identification of what are, according to current scientific knowledge, the main potential risks that could emerge from the use of nanomaterials in the future; and Identification of the issues to be discussed at the hearing including provision of background information and comments on those issues.

    For those unable to attend the consultation comments may be submitted via the EC web site.
  • Previous legislative activity calling for labeling of all foods and cosmetics containing nanomaterials now is joined by a more far-reaching call for all consumer products to be labeled in addition to asking for a review of REACH and nanomaterials.

    The action calling for labeling of consumer products with nanomaterials seems secondary to the broader look at the regulation of nanomaterials. More importantly, the European Commission has been asked to evaluate the need to review REACH concerning: Simplified registration for nanomaterials manufactured or imported; Consideration of all nanomaterials as new substances; A chemical safety report with exposure assessment for all registered nanomaterials; and Notification requirements for all nanomaterials placed on the market.

    Members of the European Parliament also asked the Commission to evaluate the need to review worker protection legislation concerning: The use of nanomaterials only in closed systems or in other ways that exclude exposure of workers as long as it is not possible to reliably detect and control exposure; A clear assignment of liability to producers and employers arising from the use of nanomaterials; and Whether all exposure routes (inhalation, dermal and other) are addressed.

    While implementation of REACH has frequently raised questions about the ability of the regulatory regime to manage safe use of nanomaterials, officials regularly indicated that enough flexibility existed within the law to gather the necessary scientific information and establish controls even though nanomaterials are not specifically mentioned in the statute. This call by Parliament could inevitably lead to REACH modifications to specifically regulate nanomaterials as a separate class of chemicals.
  • In an effort to establish worker safety guidelines the National Institute for Occupational Safety and Health (NIOSH) is looking for more scientific data on carbon nanotubes (CNTs).

    NIOSH, part of the Centers for Disease Control and Prevention (CDC), intends to evaluate the data to “develop appropriate communication documents, such as an Alert and/or Current Intelligence Bulletin, which will convey the potential health risks and recommend measures for the safe handling of these materials.”

    In a recent webinar on occupational safety sponsored by the SOCMA Nanotechnology SME Coalition, Dr. Charles Geraci made it clear the data gathering effort is not for regulatory purposes because that’s not the mission of NIOSH. That said, he did indicate that the data could be used to develop workplace safety standards. These standards could ultimately be incorporated by reference into regulatory decisions implemented by agencies like the Environmental Protection Agency.

    Attended by nearly 200 industry staff, academics and government officials, the webinar addressed a wide variety of technical issues regarding the nanomaterial production workplace.

    A recent Federal Register notice detailed the type of information requested as part of the data call-in. Examples of the information requested includes: (1) Identification of industries or occupations in which exposures to CNTs may occur; (2) Trends in the production and use of carbon nanotubes; (3) Description of work tasks and scenarios with a potential for exposure to carbon nanotubes; (4) Workplace exposure measurement data in various types of industries and jobs; (5) Case reports or other health information demonstrating potential health effects in workers exposed to carbon nanotubes; (6) Research findings from in vitro and in vivo toxicity studies; and (7) Information on control measures (e.g., engineering controls, work practices, PPE) being taken to minimize worker exposure to CNTs.

    The public comment period ends on May 15, 2009.
  • Recent talks by officials would indicate the Environmental Protection Agency (EPA) is prepared to step up enforcement of regulations governing nanomaterials.

    A few recent regulatory actions have been highly publicized but statements made by officials at last month’s GlobalChem conference and at a workshop on nanomaterial data call-ins at McKenna Long & Aldrich point to a stronger approach to enforcement.

    In talking about the Toxic Substances Control Act (TSCA) New Chemicals Program, Jim Willis of the EPA Office of Pollution Prevention and Toxics noted there have been over 60 new chemical premanufacture notices for nanomaterials since 2005. He also reminded participants about the October 31, 2008 Federal Register Notice which clarified the new chemical status of carbon nanotubes and warned of enforcement actions against producers who fail to submit Premanufacture Notices (PMNs) as required by TSCA.

    To put it all into perspective, Willis noted that only about a dozen carbon nanotube PMNs have been received by the Agency despite an estimate of over 100 producers and importers. In an effort to gather safety data on carbon nanotubes the Agency consent orders have been the primary enforcement tool.

    The consent orders have been requiring companies submitting PMNs to conduct a 90-day inhalation toxicity study, provide a characterization of the material and established use restrictions as a condition of approval. The use restrictions generally require the carbon nanotubes to be embedded in a polymer or metal matrix in addition to requiring the use of personal protective equipment for workers.

    At the GlobalChem conference in Baltimore, Maryland, EPA officials reminded attendees that reporting exemptions are still available but will be granted only if the Agency determines there is “no unreasonable risk” associated with production of the nanomaterial. While this has always been true for virtually all new chemicals it was also noted that low volume exemptions (LVEs) are unlikely because production levels of nanomaterials may be produced in such small quantities that they may never reach the 10,000 kg/year level. The agency is more likely to consider low release and low exposure (LoREX) exemption if, after a 30-day review period, if the Agency determines that the “manufacture, processing, distribution in commerce, use, or disposal of a substance will not present an unreasonable risk of injury to health or the environment.”

    The Agency also has made use of Significant New Use Rules (SNURs) as an enforcement tool and is considering additional actions under its existing TSCA authority including section 4 test rules, section 5 fines and additional reporting under section 8.

    The GlobalChem conference is an annual industry event hosted by the Society of Chemical Manufacturers and Affiliates (formerly called the Synthetic Organic Chemical Manufacturers Association) and the American Chemistry Council.
  • The National Institute for Occupational Safety and Health (NIOSH) has been a leader in identifying occupational safety issues surrounding nanotechnology and an updated version of its guidance reflects an evolution of its efforts.

    First published in late 2006, Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials has been revised to incorporate epidemiological issues for workers who may be exposed to engineered nanoparticles in the manufacturing and commercial use of nanomaterials.

    These epidemiological issues are described and discussed in a paper published by the Journal of Occupational and Environmental Medicine. The paper, Issues in the Development of Epidemiologic Studies of Workers Exposed to Engineered Nanoparticles, was written by Paul A. Schulte, Mary Schubauer-Berigan, Charles L. Geraci, Ralph Zumwalde, and John L. McKernan of NIOSH, and Candis Mayweather of Emory University.

    While NIOSH acknowledges that is may be too early to conduct epidemiological studies, it isn’t too early to identify all of the important elements of such studies and to prepare strategies for implementing such studies when they do become necessary.

    The revised document lists key issues for nanomaterial producers and users to consider with emphasis on gaining an understanding of the chemical and physical diversity of engineered nanoparticles, determining what diseases or symptoms to look for on the basis of limited research evidence, determining what to measure and how to measure it, establishing a study population, selecting intermediate biomarkers that may predict disease and development of exposure registries.
  • In separate legislative activities the European Union (EU) is moving toward improving the safety of food and cosmetics containing nanomaterials.

    Parliament has approved an update of EU legislation on cosmetics with the basic aim of the new regulation to remove legal uncertainties and inconsistencies, while increasing the safety of cosmetics. Parliament's amendments add further improvements, especially regarding the claims companies make for their products and the safety of nanomaterials used in cosmetics.

    The European Commission has taken the approach of simplifying EU law on cosmetics by replacing the 27 sets of national legislation that enacted the old cosmetics directive with a single regulation - a standard legal text directly applicable in all Member States. They also supported the essential aims of the new proposal: ensuring a high level of safety of cosmetic products in future by strengthening manufacturer responsibility and in-market control aspects while cutting red tape.

    The existing provisions banning animal testing for finished cosmetic products as of 2004, with a phasing-out period for animal tests on cosmetic ingredients, are unaffected by the new regulation.

    The Commission estimated in 2006 that about 5% of cosmetic products contained nanoparticles. As requested by the European Parliament, the new regulation introduces a safety assessment procedure for all products containing nanomaterials, which could lead to a ban on a substance if there is a risk to human health. Members of the European Parliament (MEPs) also pushed successfully for any nanomaterials present in cosmetics to be mentioned in the list of ingredients on the packaging.

    In a legislative report which was overwhelmingly adopted, MEPs want food being produced by nanotechnology processes to undergo a specific risk assessment before being approved for use and be labeled. MEPs, who also support the use of non-animal tests and the intelligent testing strategies, insist that the risk assessment methods must not imply the use of vertebrate animals.

    Furthermore, all ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of the ingredients shall be followed by the word 'nano' in brackets. While the report has been adopted by Parliament, additional action by the MEPs is required before the report recommendations become the law of the land.
  • Nanoscale silver has drawn a lot of attention for its antimicrobial applications. In the minds of some, it has also become the poster child for regulatory failure. Now, a new group has been formed to come to its defense.

    The Silver Institute and the Silver Research Consortium announced the formation of the Silver Nanotechnology Working Group (SNWG). According to a recent press release, the SNWG is an industry effort intended to foster the collection of data on silver nanotechnology in order to advance the science and public understanding of the beneficial uses of silver nanoparticles in a wide-range of consumer and industrial products.

    The formation of the group is a result of regulatory challenges some companies are facing in registering new products containing silver nanoparticles. The main purpose of the SNWG is to allow industry participants to share environmental and human health information on their respective nanosilver products and processes, including research, findings, and other data that can be combined into a summarized format. This aggregated information can then be used by individual SNWG members for their registrations of silver nano products with regulatory agencies, to provide technical assistance to ongoing federal programs in nanotechnology, and put to rest unsubstantiated claims about products containing silver nanoparticles.

    "We are pleased that four companies, Servicios Industriales Peńoles S.A. de C.V., Bayer MaterialScience, LLC, NanoHorizons, Inc., and BYK Chemie, GmbH, have joined as the initial members of the SNWG. Many other companies have expressed interest in our work, and we expect to announce new members to the group in the near future," said Rosalind Volpe, Executive Director of the SNWG.

    The SNWG is based in Research Triangle Park, North Carolina, and is operated under the auspices of the Silver Research Consortium, a research program funded by the silver industry. The Silver Institute is an international industry association, which serves as the silver industry’s voice in increasing public understanding of the many uses and value of silver.
  • In response to the growth and development of nanotechnology companies that produce and use nanoscale materials, SOCMA's Nanotechnology SME Coalition has expanded its membership categories. This new service comes on the heels of SOCMA's recent name change to the Society of Chemical Manufacturers and Affiliates, reflecting the organization's deepening commitment to the batch, custom and specialty chemical industry.

    While chemical producers still play an important role in creating new chemical substances, nanotech startups and other companies associated with nanotechnology have expanded their products and services. One new membership category is for nanotech startups which will boost chemical industry growth as they move from venture-backed research operations to fully developed private and public companies. As new nanoscale products are developed and regulatory agencies increase their activity, startups will face challenges in safety when bringing these products to the marketplace.

    There are many companies that have interests in the business of nanotechnology but do not specifically produce or use nanomaterials. These companies would join as Associate members and, as such, may participate in meetings, conference calls and SOCMA Nanotechnology SME Coalition events as well as offer their input to comments, position papers, or presentations that the Coalition may prepare.

    Companies that would qualify as Associate members include, but are not limited to, consultants, law firms, laboratories, research organizations and other industry trade groups. A reduced dues rate is currently available for these new membership categories.

    SOCMA's Nanotechnology SME Coalition represents companies of all sizes, including small and mid-sized entrepreneurial companies, engaged in the manufacture, use, or sale of nanoscale products. The Coalition focuses on environmental, safety, and health issues to promote a positive public perception of the nanotech industry, advocate on behalf of the industry to the regulatory agencies, address standards and definitions in nanotechnology, coordinate with other nanotechnology trade associations, advocacy organizations and business groups, as well as to act as an industry voice.

    SOCMA was formerly known as the Synthetic Organic Chemical Manufacturers Association.
  • The most important chemical substance regulatory statute in the U.S. is now facing challenges in many ways and some are wondering if nanotechnology is fueling the fire for change.

    U.S. chemical regulatory policy has been the subject of discussion in recent years for a variety of reasons. At the same time European chemical policy has been implementing a “no data, no market” regulatory structure that is still in its infancy yet is looked at as the gold standard by many despite any track record as yet.

    The Toxic Substances Control Act (TSCA) was enacted in 1976 and critics say the law is outdated and incapable of handle today’s technologies. Even the Environmental Protection Agency (EPA) has identified TSCA reform as one of its top five priorities.

    Several key issues frame the debate and nanomaterials provide an excellent example of why there will be many discussions ahead. One of the most important areas of concern on the minds of TSCA critics is the distinction between new and existing substances. Under TSCA Section 5 the EPA has the authority to regulate new chemical substances prior to their manufacture, import, processing or distribution and to regulate existing substances for significant new uses. The amount of data required to show an “unreasonable risk” for existing substances is typically less than that of a new substance since existing substances generally have already been evaluated to some degree. Existing substances may also have been “grandfathered” in when TSCA was first created or are considered Generally Regarded as Safe (GRAS) substances.

    Prior to the EPA’s Nanoscale Materials Stewardship Program, the Agency released a concept paper with examples of new and existing substances. Although carbon is an existing substance, carbon nanotubes, fullerenes and dendrimers could easily be described as “engineered nanomaterials” while metal oxides like titanium dioxide and zinc oxide could arguably be considered existing substances since the bulk material has always contained a nanoscale component.

    Those calling for TSCA reform also point to the EPA’s ineffective use of its test rule authority to require more data to be generated by nanomaterial producers. This issue goes hand-in-hand with the call for the EPA to generally use its regulatory powers more quickly and effectively.

    The EPA has always been pressed by industry to make regulatory determinations based on sound science but the lack of significant data on nanomaterials has put the policymakers in a difficult position. The Nanoscale Materials Stewardship Program was intended to provide data to better understand the potential risks associated with nanomaterials but many of those following the voluntary program point to the failure of the effort as an example of the need for reform of chemical regulatory policy in the U.S.

    While it’s doubtful that those calling for nano-specific regulations will be successful, there seems to be little doubt that TSCA changes are in the air. It’s only a matter of time before Congress turns its attention away from the more compelling economic issues of the day and begins to address TSCA.
  • One has to wonder how many ways to say the same thing: we need more scientific data to assess the potential hazards associated with nanomaterials.

    In yet another opinion by experts the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) released its Risk Assessment of Products of Nanotechnologies. The bottom line? The experts won’t be able to perform a complete evaluation “until there is sufficient scientific information available to characterise the harmful effects of nanomaterials on humans and the environment.”

    This is consistent with the Opinion on Safety of Nanomaterials in Cosmetic Products released in December 2007. In its report, the Scientific Committee on Consumer Products expressed concerns about the lack of information on nanomaterial hazard identification, exposure assessment, uptake, the role of physico-chemical parameters of nanoparticles determining absorption and transport across membranes in the gut and lungs, and other possible health effects.

    The SCENIHR stated in June 2007 in its Opinion on the Appropriateness of the Risk Assessment Methodology in Accordance with the Technical Guidance Documents for New and Existing Substances for Assessing the Risks of Nanomaterials that current risk assessment methodologies may not be valid for nanoparticles and risk determinations may need to be made on a case-by-case basis.

    It has been a consistent refrain extolling the need for scientific data to assess risk but the latest report is at least able to identify free (non-bound) insoluble nanoparticles either in a liquid dispersion or airborne dusts as posing the greatest risk.
  • There is no lack of activity on the part of European policymakers when it comes to the safety aspects of nanotechnology.

    The European Parliament recently drafted a report on the regulatory aspects of nanomaterials which expresses concern over the possible risks posed by nanomaterials. Noting the lack of specific guidance on how nanomaterials are identified and a lack of clarity on the extent of nanomaterials currently in commerce, the report calls for a regulatory framework specific to nanomaterials.

    “No data, no market” is the refrain of Registration, Evaluation, Authorisation and Registration of Chemicals (REACH) supporters and the draft report leans heavily on this principle by recommending a review of all relevant legislation by the end of 2009 and implementation of the principle for all nanomaterials in consumer products.

    Member of Parliament Carl Schyler, Rapporteur of the Committee on the Environment, Public Health and Food Safety was highly critical of prior regulatory reviews in the explanatory statement of the motion for a resolution. “The Commission's analysis is based on a one-dimensional, legalistic overview of the current rules but those rules are about as effective in addressing nanotechnology as trying to catch plankton with a cod fishing net.”

    On the legislative front, France is taking steps to mandate the registration of “nanoparticle substances” that are manufactured, imported or marketed in that country. As part of the environmental Grenelle project, the proposed legislation would require declarations regarding the nature of the substances, quantities produced or imported and their intended uses. The legislation would require labeling of products and it would also apply to cosmetics, pharmaceuticals and other medicinal products.

    Carbon nanotubes are the subject of an information sheet published by the United Kingdom’s Health and Safety Executive. The Risk Management of Carbon Nanotubes guidance focuses primarily on occupational exposures and leans heavily on information cited in University of Edinburgh research on carbon nanotubes.

    The study, Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot study, was published in Nature Nanotechnology in May 2008. In addition to recommended workplace precautions, the guidance also recommends the classification of carbon nanotubes as “hazardous waste.”
  • The Business and Industry Advisory Committee (BIAC) to the Organisation for Economic Co-operation and Development (OECD) lays out a set of priorities for governments to consider as they attempt to balance the benefits of nanotechnology with safety issues.

    BIAC provides representation on business and industry issues to the OECD and their input to the Working Party on Manufactured Nanomaterials has been an important element in understanding the science and challenges posed by nanotechnology. In the recently released paper, Responsible Development of Nanotechnology: Turning Vision Into Reality, the business view of challenges to the responsible growth of this enabling technology is presented.

    An important point made by the industry group is the need to continue work on developing standardized hazard and risk assessment procedures. The group stresses the need for “scientifically sound risk assessments” as the best way to inform workers, consumers, and the public about the potential risks to human health and the environment.

    The group also encouraged the continued application of existing laws rather than creation of new regulatory frameworks and supports the ongoing OECD program for testing of manufactured nanomaterials.

    Led by DuPont’s Global Director of Corporate Regulatory Affairs, Terry Medley, BIAC plays a pivotal role in several WPMN Steering Groups which are undertaking a variety of projects including development of a database on EHS research, research strategies on manufactured nanomaterials, safety testing of a representative set of manufactured nanomaterials, development of test guidelines and cooperation on risk assessment and exposure assessment.

    The OECD is an intergovernmental organization of industrialized countries in Europe, North America, the Pacific Region, and the Asia Region.
  • The National Research Council (NRC) criticized the National Nanotechnology Initiative’s (NNI) EHS research strategy and it has evoked an uncharacteristic response.

    As described in the Strategy for Nanotechnology-Related Environmental, Health, and Safety (EHS) Research, the document is a “framework for addressing the identified research needs, as well as a recommended implementation and adaptive management process.” Development of the strategy was preceded by several public meetings for stakeholder input and use of interagency working groups to coordinate the multiple research priorities.

    The primary criticism of the strategy was that it merely catalogued ongoing research rather than establishing a plan to identify the potential risks posed by the products of nanotechnology. Another key aspect of the NRC evaluation was that stakeholder input was lacking.

    The NNI response indicated that the NRC was ignoring or neglecting the facts. In a point-by-point response the NNI detailed its efforts to engage stakeholders by listing the multiple public meetings, meetings with industry groups, and federal agency interactions such as the NIOSH field investigations, Food and Drug Administration efforts, and through the EPA’s Nanoscale Materials Stewardship Program.

    The response included appendices which took the extraordinary step of pointing out both technical and typographical errors in the NRC review document. While the NNI’s research strategy still needs some refinement to present a more specific set of goals with accompanying strategies, they shouldn’t be accused of working in the dark.

    At the request of the National Nanotechnology Coordinating Office the National Research Council was asked to review the National Nanotechnology Initiative’s EHS research strategy. The safety issues are many and providing a more useful strategy will require cooperation, not criticism.
  • Building on last year’s successful workshop on the regulation of nanotechnology, NanoReg & Keller and Heckman announced Nanotechnology Today, a series of webinars designed to address the current industry outlook for nanotechnology under the new Administration and the challenges associated with the safe development of nano-enhanced products.

    This series features respected experts on several important topics in the rapidly changing world of nanotechnology regulatory policy and safety.

    “The regulatory landscape is in a state of flux. The new Congress and administration will be taking a fresh look at chemical substance management and nanotechnology just may get caught up in anticipated policy revisions,” said John DiLoreto, NanoReg founder and publisher of the NanoReg Report.

    The webinars will deliver live content via the internet and can be attended from the convenience of an attendee’s home or office where multiple attendees can participate for the cost of a single registration. The series offers small companies the assurance that they can keep abreast of science, policy, the law, and best practices.

    The first webinar, Legislation, Regulation and Small Business – 2009 Outlook is scheduled for April 1, 2009 and will feature Dr. Herb Estreicher, a partner with Keller and Heckman LLP. Dr. Estreicher provides advice on product liability risk control and assists clients with crisis management for embattled products. Also featured is Paul Stimers, associate at K&L Gates, who advises a wide range of companies and industry associations in pursuing legislation and representing their interests before Congress and federal agencies.

    The series of webinars will also include relevant topics such as Nanotechnology in the Marketplace, Nanotechnology, Food and Food Packaging, and Product Liability and Nanotechnology.
  • The Consumer product Safety Commission provided the venue for a workshop to address human & environmental exposure assessment issues. The workshop posed quite a few questions and one question was on the minds of participants: Why are we still asking the same questions?

    Several speakers made the case for additional research to determine the nature and extent of human exposures. While many believe this to be critical to understanding the potential risks posed by nanomaterials, much of the current research funding and emphasis is on the environmental fate and transport characteristics of nanomaterials and to the toxicological properties of specific nanoscale substances.

    In examining the extent of research on human exposure it became clear quite quickly that a great deal of work still needs to be done in this area. In discussing workplace exposures to nanomaterials UMass Lowell’s Dr. Susan Woskie cited the lone study done by ICON which reviewed workplace processes and related exposure levels. While lamenting the lack of additional research, Dr. Woskie made an interesting observation that the referenced study show that only 47% of the companies handling dry nanoparticles did so using a hood to prevent exposures.

    Dr. William Halperin, professor and chair of the Department of Quantitative Methods at the School of Public Health at the University of Medicine & Dentistry of New Jersey, presented an interesting review of published literature and publicly funded research. In examining research on the exposure aspects on nanotechnology compared to the hazard aspects, he was able to show a large priority disconnect.

    There are dozens of toxicological studies of nanomaterials completed or underway but only a few studies evaluating the actual exposure of nanomaterials. When considering the potential hazards of any chemical substance it is important to take into account both the hazards posed by the material and the exposure to the material. It would seem the public dialogue has centered on the potential hazards while very little attention has been paid to determining how much human exposure is actually taking place.

    The Human & Environmental Exposure of Nanomaterials workshop was sponsored by the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee, National Science Technology Council and the National Institute for Occupational Safety and Health (NIOSH).
  • Not only could the testing costs of nanomaterials be very high, it may not be completed in our lifetime.

    In a study partially funded by the National Science Foundation and the University of California, Santa Barbara, The Impact of Toxicity Testing Costs on Nanomaterial Regulation examines several scenarios to determine the economic impact on companies producing nanoscale materials.

    Recognizing the need of regulators to assess scientific data to determine the potential risk of nanomaterials, report authors conducted an assessment of costs which were optimistically assuming that potential hazards are minimal and only screening assays would be required as well as assuming the possibility of needing a more comprehensive battery of tests.

    Taking into account the costs associated with testing and the number of nanoscale materials to be tested, it is estimated that at least $249 million will be needed. Given the possibility of a more comprehensive approach to testing of all nanomaterials, that cost could approach $1.18 billion. Another key element to the research is the time it would take to complete the necessary tests. Even assuming that no new nanomaterials will be created, the estimate for time of completion ranged from 34 to 53 years.

    Authors Jae-Young Choi and Gurumurthy Ramachandran of the School of Public Health, University of Minnesota and Milind Kandlikar of the University of British Columbia published the research in Environmental Science & Technology.
  • In an open collaboration with industry health and safety professionals, the National Institute for Occupational Safety and Health (NIOSH) gathered information that provided a basis for recommendations on the medical screening of workers.

    Lacking specific information on potential hazards associated with the production and handling of nanoparticles, occupational safety professionals have struggled with establishing appropriate control measures to protect workers. Several steps can be implemented and NIOSH assembled a group of industry officials to share information and offer recommendations.

    The recommendations have been compiled in Current Intelligence Bulletin 60: Interim Guidance for Medical Screening and Hazard Surveillance for Workers Potentially Exposed to Engineered Nanoparticles.

    Led by Paul S. Schulte, Director of the Education and Information Division of NIOSH and manager of the Nanotechnology Research Center, participants in the meeting contributed to development of three key recommendations: First, measures should be taken to eliminate or minimize exposure to nanomaterials, including the use of engineering controls. Second, a hazard-based approach should be used to evaluate exposures and should be used as the basis for implementing controls.

    The third recommendation evoked a lot of response in the original meetings. Suggestions to continue the use of medical surveillance approaches brought to light a broad range of legal concerns especially when the true potential hazards of nanoparticles may not be clearly defined.

    NIOSH will continue its field investigations and data collection activities with an eye toward updating recommendations as new information becomes available.
  • Those involved with chemical regulatory policy have known for some time that challenges to the primary chemical regulatory law in the U.S. would come sooner or later. Among the reasons that it’s sooner is the robust development of nanoscale materials and the growing use of these materials in the marketplace.

    This week’s hearings by the House of Representatives’ Energy and Commerce Subcommittee Hearing on “Revisiting the Toxic Substances Control Act of 1976” drew a diverse group of stakeholders with a vested interest in the statute. The nanotech community would do well to pay attention to the issue as it could have an enormous impact as nano-enhanced products are moving from development to the marketplace.

    TSCA, as the statute is generally referred to, establishes regulatory policy for chemical substances manufactured or imported into the United States. For quite some time, nanomaterial producers avoided any thought of regarding their products as chemical substances but they have slowly come to realize their regulatory obligations.

    Nanotechnology has forced government regulators to take another look at TSCA in more than a few ways. All of the hype about nanomaterials exhibiting new and different properties draws into question the methods and data needed to assess potential risks. This is an important aspect of chemical regulatory policy since the primary mission of the Environmental Protection Agency (EPA) with regard to chemicals is to ensure the safe production and use of chemical substances.

    To make the debate more interesting, the Registration, Evaluation, Authorisation and Registration of Chemicals (REACH) chemical regulatory approach has kicked into full gear in Europe. Despite the fact that the policy approach is unproven, it has drawn a lot of supporters since it leans so heavily on the “Precautionary Principle” which basically means producers must prove the product is safe before it enters the marketplace. Under TSCA safety evaluations can take place as products are coming to market and can even be exempt from many requirements for research, test marketing and other specific situations.

    Chemical industry groups are gearing up to address challenges to TSCA and will probably even look to gain some ground in the debate. Producers would like the EPA to use sound science in assessing risk and to have agency make better use of its authority to issue rules requiring testing of existing chemicals. Lawmakers will be further pressed to require EPA to collaborate more with other agencies like the FDA and the European Union so producers generating standardized test data can leverage use of the data more broadly.

    One additional ingredient in the recipe for change is the newly emboldened Congress. Several members of the democratic majority have sought for some time to take action on chemical regulatory policy and they now believe they have the full support of our new President. They only real question is one of timing. With so many major issues facing our government it may take a while for chemical regulatory policy to take center stage but clearly it’s not a matter of if, but when, it happens. Stay tuned.
  • When does real stakeholder dialogue begin? In California, stakeholders clearly include academics and activists but input from industry doesn’t seem to have much of a chance.

    Recently a letter was sent to nanotech manufacturers of carbon nanotubes “requiring information regarding analytical test methods, fate and transport in the environment, and other relevant information.” This is certainly an important aspect of guiding regulatory policy when the science is not as robust as may be needed.

    What’s curious about the California Department of Toxic Substances Control (DTSC) approach is the emphasis on a public dialogue without any significant nanotechnology industry involvement. When the regulatory controls are enacted, aren’t the industrial entities going to bear the greatest burden to comply?

    A good example of the lack of public industry involvement is the two symposia held last year and the one planned for next month. Speakers from several activist groups and non-governmental organizations, state and federal regulatory officials, and academic researchers dominate the podium. The only industry representative making a presentation is Unidym which is scheduled for the symposium in March.

    One has to ask why only one company has been involved in the “public dialogue.” With dozens, if not hundreds of manufacturers creating products (including carbon nanotubes) in the California marketplace, it would seem that nanotech companies are not welcome when it comes to public stakeholder dialogue. With at least three U.S. industry trade groups representing nanomaterial manufacturers it would seem they represent an opportunity to include a broader view from the industry which is the primary target for regulatory action. Too bad the DTSC doesn’t seem to feel it’s important.
  • Safety, the Environment and Regulatory Policy Take Center Stage Several upcoming workshops and symposia on both sides of the Atlantic will address nanotechnology safety and environmental impacts.

    Human & Environmental Exposure Assessment of Nanomaterials Workshop

    The National Nanotechnology Coordinating Office, on behalf of the NSET Subcommittee, will hold a free workshop February 24-25, 2009 to provide an open forum to discuss the state-of-the-art of the science related to environmental, health, and safety (EHS) aspects of engineered nanoscale materials in the area of Human and Environmental Exposure Assessment, one of the five EHS research categories identified in the Strategy for Nanotechnology-Related Environmental, Health, and Safety Research.

    Nanotoxicology: Health & Environmental Impacts

    A symposium on February 27, 2009 is aimed at bringing together eminent scientists at the forefront of the nanotoxicology field to present their current research findings and discuss the potential impact of nanomaterials on human health and the environment. This event will present an opportunity for toxicologists, nanotechnologists, industrial members and governmental regulatory agencies to interact and discuss the latest developments in this controversial field.

    DTSC Nanotechnology III Symposium, "NanoRegulation - Anticipating the Smallest Threats and the Largest Opportunities"

    Third in a series on nanotechnology, this event will focus on the regulatory aspects of nanotechnology, EPA's role, and California Department of Toxic Substances Control's chemical information call-in program including nanoscale materials.
  • Food Safety Developing Into a Major Nanotechnology Issue Nanotechnology has long been recognized as an enabling technology with a far-reaching impact on a broad array of products. The food industry has quietly incorporated many nano-enhanced products into the mix and safety is a growing concern.

    From nano-enhanced food to packaging with active displays, technology is changing the way food is made, used, delivered and marketed. Great Britain’s House of Lords Science and Technology Select Committee appointed a Sub-Committee to investigate the use of nanotechnologies in the food sector.

    The Committee intends to focus on the following areas: food products, additives and supplements; food contact packaging; food manufacturing processes; animal feed; pesticides and fertilizers; and products that may come into contact with food, such as food containers and cooking utensils.

    The public has been invited to “submit evidence” by March 13, 2009 on several topics. In a statement by Lord Krebs, Chairman of the Science and Technology Sub-Committee on Nanotechnologies and Food, he noted the rapid development of nanotechnology in the food sector and expressed concern for a lack of information on the subject.

    "Our inquiry will explore four key aspects of the use of nanotechnologies: the state of the science and its current use in the food sector; health and safety implications; the regulatory framework, and public engagement and consumer information.

    "It is critical that the UK remains fully engaged in this fast developing field and plays a key role in the industry and its development. We intend to highlight those areas where our understanding of the use of nanotechnologies in food needs the most urgent attention, allowing us to take action to ensure appropriate steps are taken."
  • Canadian regulatory officials have seen the results of the voluntary information collection programs in the U.S. and Great Britain and it appears they are about to take a different route.

    Environment Canada is about to require all companies and institutions that used one kilogram or more of nanomaterials in 2008 to provide information on those substances. Canadian officials have not indicated what information will be required or when the notice will be sent out.

    Canadian officials have long wrestled with the option of asking for voluntary submissions but privately indicated a preference for a more formal regulatory approach. Given the poor results of the UK’s Voluntary Reporting Scheme and the mixed results of the U.S. Environmental Protection Agency’s Nanoscale Materials Stewardship Program, there would appear to be sufficient justification for the mandatory approach.

    While some news outlets are citing this as the first government requiring mandatory reporting, such declarations would seem to ignore the EPA’s requirements for specific Premanufacture Notices for nanomaterials that have already been submitted and the recent release of Significant New Use Rules.
  • Challenges to the Toxic Substances Control Act (TSCA) as a tool for the regulation of chemical substances continue as the Government Accountability Office (GAO) puts chemical assessments in the crosshairs and California turns up the heat on producers and users of carbon nanotubes.

    For some time the Environmental Protection Agency (EPA) has been criticized for the way it assesses potential hazards posed by chemicals and the length of time it takes in doing so. Some in the legislative branch of the U.S. Government have waited a long time to address this issue and it appears the GAO has added fuel to the fire.

    In a new report, High Risk Series: An Update, the GAO used its biennial report to identify three new high-risk areas. Of importance to the nanotech community is the new area “Transforming EPA’s Processes for Assessing and Controlling Toxic Chemicals” which criticizes the EPA’s ability to make informed decisions.

    In language similar to that used by activist groups regarding nanotechnology, “Neither Congress nor EPA has implemented the most important recommendations aimed at providing EPA with the information needed to support its assessments of industrial chemicals. Without greater attention to EPA’s efforts to assess toxic chemicals, the nation lacks assurance that human health and the environment are adequately protected.”

    The GAO cited chemical producer requirements to provide information as part of the Premanufacture Notice process but noted that “while 85 percent of notices lack any health or safety test data, the agency does not often use its authority to obtain this information.”
  • The great nation of California has once again jumped to the head of the line and determined that the federal government isn’t doing enough to regulate nanomaterials.

    In a letter to over two dozen universities and nanotech companies who manufacture or import carbon nanotubes into California, the Department of Toxic Substances Control (DTSC) is “requiring information regarding analytical test methods, fate and Transport in the environment, and other relevant information from manufacturers of carbon nanotubes.” Recipients of the call-in letter have 365 days to respond.

    Much of the research and environmental information requested by the DTSC is publically available through peer-reviewed journals and publications although each producer will probably have different information based on its own specific production methods and material handling procedures.

    One interesting aspect of the data call-in is the requirement to provide value chain information right down to a list of customers. Since this information is extremely valuable to nanotech companies much of this information will be subject to requests for confidentiality and will probably be withheld from the public eye.

    Other nanomaterials will be considered for additional information call-ins during 2008/2009. Substances specifically identified by DTSC for future data call-ins include nanometals and quantum dots.
  • After two years of voluntarily seeking information on nanomaterials in Great Britain the debate now turns to the value of the information collected.

    The Voluntary Reporting Scheme (VRS) for Manufactured Nanomaterials was initiated in September 2006. Over the two-year period of the program only a dozen submissions were received by the UK’s Department for Environment, Food and Rural Affairs (Defra).

    The VRS sought information on engineered nanoscale materials that are free at any stage of a product’s life-cycle. All organizations manufacturing or using nanomaterials and anyone involved in nanoscience research or managing wastes consisting of engineered nanoscale materials were asked to participate.

    In a recent meeting of the Nanotechnology Research Coordination Group (NRCG), it was suggested that there are only a few nanotechnology companies in the UK which suggests that a small number of submissions shouldn’t surprise anyone. However, given the increasing number of nano-enhanced products in the marketplace policymakers will need a great deal of information if they are to base regulatory policy on sound science.

    The NRCG was set up to coordinate publicly funded research into the potential risks presented by the products and applications of nanotechnologies. Defra chairs the NRCG and the membership includes Government Departments, Regulatory Agencies and the Research Councils.

    With input from stakeholders, Defra will prepare a final report to determine if the objectives of the program have been met.
  • The International Center for Technology Assessment (CTA) petition to the EPA for regulatory action on nanoscale silver as a pesticide last May has evoked quite a response from the public. Surprisingly, most of the comments from the public are not in support of the petition.

    The Environmental Protection Agency (EPA) has extended the comment period at the request of several petitioners to March 20, 2009.

    Public response to the Federal Register notice has been remarkable. Over 670 comments have been submitted to the docket with a large proportion of responders imploring the EPA to not regulate colloidal silver.

    It would appear that the issue has received some traction from those in the consumer health products industry. Many of the comments suggest that regulation of silver as an antimicrobial would have a negative impact on the availability of silver in health care products. Many of those providing comments described their medicinal and nutritional use of colloidal silver and espoused the virtues of its antimicrobial properties. Others argued that the federal government actions are placing unreasonable regulatory burdens on the public.

    The petition asked the agency to regulate all nanoscale silver products as pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and it is still under review.
  • New administration, recycled legislation. Reauthorization of the National Nanotechnology Initiative (NNI) cleared the House of Representatives last year but the new Congress will need to do it all over again.

    H.R. 554, identical to H.R. 5940, passed by a 407-6 margin in the 110th Congress. While it reauthorizes the NNI it also places a renewed focus on the federal government’s role in nanotechnology health and safety research.

    “The range of potential applications of nanotechnology is broad—from solar cells to sunscreen, from electronics to energy transformation and storage, to medicine and health,” stated Chairman Bart Gordon (D-TN). “It is important that potential downsides of the technology be addressed from the beginning in a straightforward and open way, both to protect the public health and to allay any concerns about the validity of the results. A thorough, transparent process that ensures the safety of new products will allow both the business community and the public to benefit from the development of these new technologies.”

    The legislation assigns responsibility to a senior White House official to ensure that a detailed implementation plan for EHS research is developed and executed – a plan that specifies both near-term and long term objectives, provides a timeline for achieving the near-term objectives, and identifies the funding, by objective and by agency, necessary to carry it out. The legislation also requires the plan to be responsive to recommendations from the NNI external advisory committee and requires the development of a publicly accessible database containing every EHS research project supported under the NNI.
  • Regardless of where you stand on the issue of nanomaterial safety you will like the latest report on the Environmental Protection Agency’s voluntary program to collect information on nanomaterials.

    In the recently-released Nanoscale Materials Stewardship Program: Interim Report the Environmental Protection Agency (EPA) declared success for the program but acknowledged “a number of environmental health and safety data gaps.”

    By December 8, 2008 the Agency received submissions from 29 companies and trade associations with information on 123 nanoscale materials. Using a process similar to that of a new chemical review, the Agency is evaluating information collected under the Basic Program.

    Despite satisfaction with participation in the Basic program, agency officials have expressed disappointment over the level of participation in the In-Depth Program which would allow participants to work with EPA to develop new data on representative nanoscale materials over a much longer time frame that the original 6 months for the Basic Program. Only 4 companies agreed to participate in the In-Depth Program and sources indicate their participation was something less than voluntary.

    While nanomaterial producers expressed gratification over the voluntary level of participation in the Nanoscale Materials Stewardship Program (NMSP), others identified some concerns. "EPA's voluntary approach has failed to provide both EPA and the public with critical data on the full range of nanomaterials in production and use in the United States," said Dr. Richard A. Denison, a senior scientist at Environmental Defense Fund. "With hundreds of nano products already on the shelves, EPA has squandered precious time while it slowly developed and pursued a program that informed stakeholders cautioned would not yield what was needed."

    The concept of defining all nanomaterials as “new” under the Toxic Substances Control Act (TSCA) has been a hotly-debated topic. Recently, however, the EPA has made it clear that some substances will be considered “new” and publicly declared carbon nanotubes as an example. The interim report furthers the debate by declaring that “the Agency has identified 18 nanoscale materials in the NMSP submissions as potentially being ‘new’ chemicals under TSCA; these include nanoscale materials that are at the research and development stages.”

    In acknowledging the need for additional information on the potential risks posed by nanomaterials the Agency is considering taking additional steps to help address the information gaps. As previously written in the NanoReg Report, the EPA has been attaching consent orders to Premanufacture Notices (PMNs) for multiwalled carbon nanotubes requiring manufacturers to conduct 90-day inhalation toxicity studies in rats. The Agency also promulgated significant new use rules (SNURs) for siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles requiring a 90-day inhalation toxicity test to “characterize the human health effects" of the substances.

    The EPA has made a concerted effort to work with all stakeholders to make this program a success. Aware of the need for sound science to support its regulatory responsibilities, the Agency has been available to discuss the voluntary effort with just about anyone who would listen.

    Industry groups such as the Synthetic Organic Chemical Manufacturers Association Nanotechnology SME Coalition, the NanoBusiness Alliance and the American Chemistry Council’s Nanotechnology Panel supported the voluntary program from its inception and encouraged member companies to participate. Approximately half of all of the NMSP participants belong to these three organizations.

    Additional participation in the voluntary program is encouraged as the program is not scheduled to end until January 2010. In the meantime, the EPA will continue to evaluate all of the information from the Basic and In-Depth Programs, ongoing testing underway through international organizations such as the Organisation for Economic Co-operation and Development (OECD), the EPA Office of Research and Development and through the National Nanotechnology Initiative.

    The interim report is clear about the EPA’s policy on nanoscale materials. From a regulatory perspective, “the Agency will take any necessary action to prevent unreasonable risks to human health and the environment.” This includes and required regulatory action necessary by exercising its authority under TSCA section 4.
  • Defra’s voluntary program to collect information on nanomaterials has not gone as planned but it didn’t prevent the UK’s Royal Commission on Environmental Pollution (RCEP) from moving forward with a series of recommendations on nanotechnology.

    The RCEP recently published Novel Materials in the Environment: The case of nanotechnology which examined the development of manufactured nanomaterials and the potential impact of these materials on the environment.

    Concerned about “potential releases to the environment from industrial applications of metals and minerals that have not previously been widely used,” the Commission reviewed innovations related to the benefits of nanotechnology while identifying the challenges of these new materials.

    Three priorities were identified that reflect a prudent yet well-understood discussion on the topic. First, the RCEP expressed the opinion that all nanoscale materials of a certain size should not be treated in the same way. Instead, emphasis should be placed on the properties and functionality of specific nanomaterials.

    Second, a directed research program on the properties and functionalities of nanomaterials should be established in order to inform risk assessment and risk management strategies.

    Third, lacking specific information on nanomaterials, governance will need to be flexible to accommodate regulatory needs as information develops.

    The RCEP solicited input on its report at the end of April 2007 and received comments from over 160 companies, academia, trade groups and government officials by July 2007.

    The Royal Commission on Environmental Pollution is an independent body, appointed by the Queen and funded by the Government, which publishes in-depth reports on what it identifies as the crucial environmental issues facing the UK and the world.
  • With all of the controversy over nanoscale silver, at least one company has proven that regulatory hurdles can be overcome.

    Many who follow the regulation of nanotechnology products have asked how the Federal Insecticide, Fungicide and Rodenticide Act regulatory process will impact nanoscale materials. Nanoscale silver has been a particularly interesting subject due to the wide variety of products incorporating the substance with company claims focusing on its antimicrobial properties.

    The Environmental Protection Agency’s (EPA) Office of Pesticide Programs pays close attention to antimicrobial claims and perhaps this registration will trigger enforcement action against dozens of other companies making similar claims.

    The silver nanoparticle “coating” used by Applied Nanoscience is used to coat or impregnate air filter media. "This positive development with our manufacturing partner moves ANI forward in supplying our proprietary technology to license partners globally while in full compliance in an industry with increasing regulation," said Thomas K. Allen, ANI President and CEO.

    This is an interesting development given the International Center for Technology Assessment petition to the EPA for regulatory action on nanoscale silver as a pesticide. The agency is currently asking for public comment on the issue.

    Applied Nanoscience Inc., founded in June 2004, is a marketer and developer of innovative, high-performance filtration products and systems.
  • The Environmental Protection Agency (EPA) has taken a big step in showing stakeholders that it intends to keep an eye on products using nanoscale silver.

    In a recent Federal Register notice, Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides; Notice of Availability, the agency responded to the International Center for Technology Assessment petition to the EPA for regulatory action.

    The petition requests that the Agency “classify nanoscale silver as a pesticide, require formal pesticide registration of all products containing nanoscale silver, analyze the potential human health and environmental risks of nanoscale silver, take regulatory actions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) against existing products that contain nanoscale silver, and take other regulatory actions under FIFRA as appropriate for nanoscale silver products.”

    The Project on Emerging Nanotechnologies’ inventory of consumer products lists hundreds of manufacturer-identified products that contain nanosilver making antimicrobial claims. The products include toothpaste, wound dressings, socks, curling irons, air filters, kitchenware and dozens of other consumer products.

    The EPA “has determined that the petition raises issues that potentially affect private and public sector stakeholders.” Comments are due January 20, 2009.
  • For some time there has been a call for a proactive safety research plan for nanotechnology and now the National Research Council (NRC) concurs.

    The National Nanotechnology Initiative has been tremendously successful in its efforts to spur the research and development of nanomaterials. We now have a wide range of products and nanomaterials in every day consumer use. One area of concern, however, is the safety of these new materials and the fear that there was no coordinated effort to conduct the research necessary to establish the possible risks of nanomaterials.

    Consumer trade groups environmental activists, policy makers, and industry scientists sought to have a comprehensive program of safety research as part of the ongoing efforts of the National Nanotechnology Initiative (NNI). With billions of dollars allocated to research and development many were of the opinion that a greater proportion of available funds should support safety research.

    To no one’s surprise, the NRC found the NNI’s Strategy for Nanotechnology-Related environmental Health and Safety Research lacking “input from a diverse stakeholder group, a vision and a clear set of objectives, a comprehensive assessment of the state of the science, a plan or road map that describes how research progress will be measured, and the estimated resources required to conduct such research.”

    With nanotechnology development underway at academic institutions, government laboratories and industrial facilities there is no central authority or government body that has the responsibility for coordinating large amounts of discontinuous information on a variety of nanomaterials.

    Earlier this year the U.S. House of Representatives’ Science and Technology Committee developed legislation (H.R. 5940) that requires the development of an EHS research plan that specifies near-term research goals, along with timelines and milestones for achieving these goals; identifies multi-year funding requirements for each goal; specifies responsibilities for each participating agency for achieving the goals; and requires annual reassessments of progress, including review by an outside committee of experts.

    The legislation also assigns responsibility to an associate director of the Office of Science and Technology Policy for developing and implementing the EHS research plan. This legislation, designed to address deficiencies in the NNI research program, passed by a large margin earlier this year.
  • Several companies have touted the lack of nanomaterials in their sunscreen products but due to research conducted by Consumers Union the concept of truth-in-advertising has taken a hit.

    Consumers Union sent a letter to the Food and Drug Administration (FDA) urging the agency to require safety assessment data on nanoparticles in sunscreens after conducting a study of "nano-free" sunscreens. Four of the five products claimed by companies to have no nanoparticles in their formulations were found to have nanoscale titanium dioxide or zinc oxide in their products.

    In a letter to FDA Commissioner Andrew C. von Eschenbach on October 30, 2008, Senior Scientist Michael Hansen discussed the findings of the research and suggested several regulatory actions by the FDA.

    In addition to suggesting that a safety assessment be conducted on nanomaterials in all sunscreens, the FDA was urged "to require manufacturers to disclose the presence of nanoparticles on the label of any cosmetic or over-the-counter drug product that contain such particles, and to immediately investigate misstatements by manufacturers to Consumer Reports about absence of these nanoparticles in sunscreen products. Furthermore, we specifically urge the FDA to investigate whether the failure to disclose the presence of nanoparticles renders these sunscreen products misbranded."

    The FDA has not responded publicly to the letter. This new finding, does, however, put increased pressure on the agency to take some regulatory action on nanoparticles. The chorus of criticism is attaining a significant volume as the agency has spent the last few years pondering the issue without taking any real action.
  • Silver has always been known for its potentially toxic effects on biological organisms and the growing use of nanoscale silver is causing concern about the possible impact on the environment.

    In a report for the Project on Emerging Nanotechnologies, Silver Nanotechnologies and the Environment: Old Problems or New Challenges?, Dr. Samuel Luoma uses his significant environmental expertise to provide extensive insight into the use of nanoscale silver and the challenges in preventing environmental harm.

    Dr. Luoma provides "12 lessons for managing environmental risks from nanosilver" to highlight the elements of a research and management strategy. In these lessons, he points out that over one third of the nanosilver products on the market in 2007 had the potential to release silver particles into the environment.

    The report recognizes the lack of any specific examples of adverse effects caused by silver in the environment and even acknowledges that a small amount of silver occurs naturally which is frequently found in natural waters and sediments.

    However, the additional contributions of silver to the environment are beginning to raise questions about the ultimate impacts. Even when Samsung sought approval for its washing machine which releases ionic silver particles the outcry for action came primarily from those concerned about the negative impact on biological wastewater treatment systems.

    Silver has long been known to be toxic to bacteria which is why it is becoming a popular antimicrobial in hard surfaces, sprays, wound dressings, socks, shirts and a wide variety of other applications.

    With so many antimicrobial claims made by companies using nanoscale silver it will only be a matter of time before Environmental Protection Agency policymakers come to the realization that they will need to be far more proactive in applying Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) regulations to nanoscale materials.
  • The Competent Authorities Subgroup on Nanomaterials (CASG) is holding meetings on the registration of nanomaterials in Europe and the outcome of their discussions could have a significant impact on producers of nanoscale materials.

    After June 1, 2008, companies manufacturing or importing chemical substances in the European Union in quantities of 1 metric ton or more per year are required to register them under REACH (Registration, Evaluation, Authorisation and Registration of Chemicals). This chemical substance regulation has recently been set into motion after years of preparation and establishment of the European Chemicals Agency (ECHA).

    The question of the registration of nanomaterials has been the source of many discussions among policymakers, industry and non-governmental organizations. While some felt the production volume of some nanomaterials would not reach the trigger quantities, this would present risks not envisioned when the regulations were established.

    Since many nanomaterials have unique properties at the nanoscale, there were concerns that the toxicological effects would be significantly different from bulk material counterparts and the potential risks would not be addressed in the regulatory process.

    A draft document for discussion by the CASG on nanomaterials reveals one approach to consider nanoscale substances a subset of their larger counterpart which would require the nanomaterials to be registered along with the larger volume substances. The information requirements regarding registration dates for the nanomaterials will be determined by a range of possible circumstances.

    While much of the thinking on the categorization of nanomaterials has not yet been finalized it is apparent that these substances will be facing a future which entails the development and submission of an extensive amount of hazard information.
  • Following close on the heels of the EPA's clarification of carbon nanotubes as a "new substance" under the Toxic Substances Control Act, the agency has once again exerted its regulatory authority by promulgating significant new use rules (SNURs) for two nanoscale materials.

    When the Environmental Protection Agency (EPA) issued significant new use rules for dozens of chemical substances last week it was the first time the action was ever take on a substance identified specifically as a nanoparticle. Expressing concern for "lung effects" for siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles, the EPA "has determined that a 90-day inhalation toxicity test would help characterize the human health effects" of the substance.

    The agency does not believe that the manufacturing of the silica nanoparticles pose an unreasonable risk but determined that workers not using impervious gloves and a NIOSH-approved respirator could face serious health effects.

    This direct final rule requires anyone who intends to manufacture, import, or process any of these chemical substances in what is determined to be a "significant new use" to notify the EPA at least 90 days in advance on such activity. This will give the agency an opportunity to evaluate the intended use of the substance and place any restrictions it deems necessary. It can also go beyond placing conditions by implementing a prohibition on any intended activity.
  • Carbon nanotubes are hardly new but the Environmental Protection Agency has concluded that they are a "new substance" when it comes to the Toxic Substances Control Act (TSCA).

    Ever since the Environmental Protection Agency (EPA) introduced the Nanoscale Materials Stewardship Program (NMSP) it has sought to clarify how it looks at nanoscale materials. In a recent Federal Register notice the agency made very clear the regulatory status of carbon nanotubes.

    The notice states that "EPA generally considers CNTs to be chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA Inventory."

    Those who sought to communicate the possible hazards associated with carbon nanotubes have at times pointed to graphite and other forms of carbon. Using the hazard information of those substances instead of data specific to carbon nanotubes has often been held out by non-governmental organizations and activists as one of the reasons for additional regulation of nanoscale materials.

    This action follows on the heels of the release of a sanitized Consent Order that the EPA has been attaching to Premanufacture Notices (PMNs) for carbon nanotubes. The Consent Order requires companies to conduct a 90-day inhalation study in rats and also places additional requirements for material characterization and the use of personal protective equipment in the manufacturing environment.

    When the Consent Order became public, Environmental Defense identified Swan Chemical as the company that agreed to the sanitized order because the company had previously released a press release with the claim that "Swan pioneers nanomaterial controls with EPA." Swan is using it to enhance its marketing efforts by proclaiming that "Thomas Swan is the only organisation currently licensed to sell commercial quantities of carbon nanotubes in the USA" in the most recent press release from the company.

    With the continued explosive growth of the carbon nanotube business, the substance will remain a high priority for regulation by the EPA and other regulatory agencies across the globe.
  • While much of the safety research on nanoscale materials has centered on carbon nanotubes, fullerenes have not received as much attention. Perhaps a little more research on the possible environmental effects of fullerenes is warranted.

    Perhaps because fullerenes, or buckyballs if you prefer, have not been found to be as commercially successful, the relative paucity of information to date has not provided much insight on the possible environmental effects of the nanoscale substance.

    A recent study, Effects of C60 Fullerene nanoparticles on soil bacteria and protozoans, showed some slight soil protozoan sensitivity and a four-fold decrease in fast-growing bacteria. Also, the researchers noticed a very small, but persistent, change in the genetic diversity of both the bacterial and protozoan community, caused by the fullerenes.

    Researchers made note of the need for additional longer-term studies to monitor potential impacts on the environment and the difficulty in establishing environmental regulations due to the large number of nanoscale materials. The study was funded by the European Commission's Environment Directorate-General and results were published in Environmental Toxicology and Chemistry.
  • When evaluating the potential risks associated with nanomaterials, getting expert opinions at the earliest possible stage of product development may be the most important step to take.

    Published recently in the Journal of Industrial Ecology, experts were interviewed by researchers at the University of Virginia on two sets of questions about the use & disposal scenarios and risk triggers for a particular nano-product. Use and disposal scenarios covered the potential environmental and public health risks associated with the use and disposal of the product. Risk triggers covered a laundry list of potential risk associated with nanomaterials and nanotechnology.

    In this case study, toothpaste, sunscreen, air freshener, dietary supplement, battery, tennis racquet, field emission display, and a MRI contrast were compared because each product had a particular nanomaterial as an ingredient. In the final analysis, after scenarios and triggers were scored, a battery with nanoscale lithium ions was found to be least risky, while air freshener, toothpaste, sunscreen, and an MRI contrast agent were found to be the most risky.

    The intention of the study, Identification of Risks in the Life Cycle of Nanotechnology-Based Products, was to provide a case study on how these interviews would generate at least a first-pass analysis on the potential risks of products. The need for expert elicitation arises because most nanomaterials simply do not have enough data for a thorough traditional risk assessment.

    Expert elicitation offers a serious first step towards prioritizing risk research along a number of nanotechnology-based products, as smaller firm do not possess the resources in money or time to carry out the research needed. For government and academic researchers, analyzing the potential risk of products can provide avenues for more interesting research by comparing notes with colleagues in the field in a systematic, objective way.

    Future research could focus on the appropriate weighting of scenarios and triggers associated with nano-enhanced products. In some cases, it is difficult to compare apples and oranges in assessing potential risks of nano-enhanced products.
  • Carbon nanotubes may be just carbon but when it comes to Europe’s Registration, Evaluation, Authorisation and Registration of Chemicals (REACH), there’s more to the story.

    In June 2008 the NanoReg Report first reported on the proposal to amend the REACH program so carbon and graphite would no longer be exempt from the requirement to submit safety data. REACH requires industry to provide safety data on chemical substances prior to the substances entering the market.

    The REACH amendment took effect on October 11, 2008 and the action includes removal of the exemption for Vitamin A which was removed because the substance “may present significant risks of reproductive toxicity.” Carbon, graphite, and Vitamin A were previously listed in Annex IV which lists substances that are exempted from the registration, evaluation and downstream user provisions of REACH because sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties.

    Annex V of REACH sets out substances that are exempted from the registration, evaluation and downstream user provisions of REACH because registration is deemed inappropriate or unnecessary and their exemption does not prejudice the objectives of REACH. Several additional substances were added to Annex IV or moved from Annex V to Annex IV.

    The recent reports of the Environmental Protection Agency’s Consent Order for a 90-day inhalation study as a requirement for approval in the Premanufacture Notice process is consistent with the growing regulatory approach requiring additional safety data on carbon nanotubes.
  • Concern for the safety of food is a very hot topic across the globe and when it comes to nano-enhanced food or packaging, Europe is no exception.

    Nanotechnology is rapidly being incorporated into a variety of foods and food packaging which is raising concerns about safety. The European Food Safety Authority (EFSA) Scientific Committee has been asked by the European Commission to “provide a scientific opinion on potential risks arising from nanoscience and nanotechnologies on food and feed safety.”

    In the EFSA Draft Opinion of the Scientific Committee on the Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety, the Committee made several recommendations which primarily suggest the gathering of additional characterization and information so traditional risk assessment methods can be used to evaluate food safety.

    Nanoscale materials are now being used in food products in several ways. Some nanomaterials provide more efficient nutrient delivery and others improve bioavailability of individual food constituents. Food packaging has seen the increased use of nanoscale materials as gas and moisture barriers in flexible packaging, as biosensors to detect biological contamination, in inks for labeling and as RFIDs on packages.

    The food safety question the Committee intends to address includes the potential risks associated with direct food contact in addition to the environmental impact of waste food and packaging containing nanomaterials.

    Interested parties are invited to submit comments and pertinent scientific information by December 1, 2008.
  • Nanotechnology definitions have been a long time coming but some basic terms have been finalized.

    While special properties remain a key to defining nanoscale, to 1 to 100 nanometer range for nanoparticles has become the accepted definition. This International Organization for Standardization (ISO) definition mirrors the most commonly accepted definition by the nanotechnology community, researchers and regulators.

    The Chair of ISO Technical Committee 229, Peter Hatto, has worked long and hard leading a group of professionals shaping the definitions which are characterized as technical specifications. In releasing the definitions he commented: “International standardization will play a critical role in ensuring that the full potential of nanotechnology is realized and that nanotechnology is safely integrated into society. Standards will help create a smooth transition from the laboratory to the marketplace, promote progress along the nanotechnology value chain and facilitate global trade.”

    ISO initiated activities in 2005 to provide “terms and definitions related to particles in the field of nanotechnologies.” Harmonized definitions like those published in ISO/TS 27687:2008 will facilitate communications among all organizations and individuals working on nanotechnology products.

    Several key definitions are included in the ISO publication. For example, a nanoparticle is a particle with all three dimensions in the nanoscale. A nanofiber has two dimensions in the nanoscale with a larger third dimension with a nanotube defined as a hollow nanofiber and a nanorod as a solid nanofiber.

    ISO/TS 27687:2008, Nanotechnologies – Terminology and definitions for nano-objects – Nanoparticle, nanofibre and nanoplate, is the first part of a projected series on terminology and definitions documents covering the different aspects of nanotechnologies.
  • The potential risks associated with nanomaterials may not be fully understood but it didn’t stop one insurance carrier from taking a defensive position on potential liability.

    Reports of a recent study of carbon nanotubes (CNTs) led to a press release by the Continental Western Insurance Group (CWIG) excluding “coverage for the, as of yet, unknown and unknowable risks created by products and processes that involve nanotubes.” The exclusion was added to make to make customers “explicitly aware of our intent not to cover injury and/or damage arising from nanotubes, as used in products and processes…”

    CWIG specifically mentioned the CNT report which linked health effects to similar effects caused by asbestos and indicated the unknown potential liability was a risk they are unwilling to accept. The poorly written exclusion reflected a lack of understanding of what constitutes a nanomaterial or even nanotechnology.

    By identifying nanotechnology rather than nanomaterials, the endorsement is so sweeping that virtually eliminates coverage for contact with any nano-enabled product. The "endorsement excludes bodily injury, property damage, and personal and advertising injury related to the exposure of nanotubes and nanotechnology in any form. This includes the use of, contact with, existence of, presence of, proliferation of, discharge of, dispersal of, seepage of, migration of, release of, escape of, or exposure to nanotubes or nanotechnology."

    Interestingly, the press release and supporting documents were removed from the company’s web site once a BNA report on the action was made public. The exclusion seemed to be written by lawyers with virtually no knowledge of the nature and extent of nanomaterials already in commerce. It is unknown at this time if the exclusion will go into effect on November 15, 2008 as originally planned.

    CWIG is a regional commercial property and casualty insurer that owns and operates Continental Western Insurance Company, Union Insurance Company, Firemen's Insurance Company of Washington D.C. and Acadia Insurance Company. CWG is a wholly-owned and reinsured member of the W.R. Berkley Corporation

    While it’s not unprecedented for liability to be restricted for emerging technologies, this particular action highlights the need for additional scientific information. Only then will insurers be in a position to factor potential risks into liability equations when establishing rates and determining specific policy exclusions.
  • As a leader in nanotechnology worker safety, the National Institute for Occupational Safety and Health (NIOSH) continues to actively engage in relevant research and partnerships.

    A recent posting on the NIOSH web site describes two studies undertaken by NIOSH researchers and others. One study, Inhalation Versus Aspiration of Single Walled Carbon Nanotubes in C57BL/6 Mice: Inflammation, Fibrosis, Oxidative Stress and Mutagenesis, showed that mice exposed to aerosolized carbon nanotubes produced the same dose-related effects as mice that were exposed through direct aspiration.

    The second study conducted by researchers, Filtration Performance of NIOSH-Approved N95 and P100 Filtering Facepiece Respirators Against 4 to 30 Nanometer-Size Nanoparticles, indicated that “NIOSH-approved air-purifying respirators provide expected levels of filtration protection against nanoparticles.”

    NIOSH also highlight its partnerships in two areas. As part of the International Alliance for NanoEHS Harmonization, NIOSH will assist in the establishment of scientific protocols to promote harmonization in the toxicological testing of nanomaterials. NIOSH is also leading the formation of a workshop by the Organization for Economic Cooperation and Development (OECD) on the assessment and mitigation of workplace exposures to nanomaterials.

    In addition, Vladimir V. Murashov, Ph.D., Special Assistant to the Director, NIOSH, and John Howard, M.D., former Director of NIOSH were presented an award by the American Biological Safety Association for the paper Biosafety, Occupational Health, and Nanotechnology. The award recognizes "significant contributions in areas of scientific investigation and/or health and safety."
  • According to a recent report, the Environmental Protection Agency (EPA) will give the public an opportunity to comment on the recent citizen petition on nanoscale silver.

    Since the International Center for Technology Assessment (CTA) petition to the EPA for regulatory action on nanoscale silver as a pesticide last May, no agency action has been made public. According to the EPA’s web site, the petition asking the agency to regulate all nanoscale silver products as pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) is still under review despite a typical 90-day review period.

    In a recent posting on the Nanotechnology Law Blog, “EPA is preparing a Federal Register notice that will invite public comments on the ICTA Petition. It is not yet known how long the comment period will be or when the notice will be published in the Federal Register.”

    The posting also indicates that the action planned by the EPA has been confirmed by an attorney at the CTA. The CTA is a non-profit, bi-partisan organization committed to providing the public with full assessments and analyses of technological impacts on society.
  • The public debate on nanotechnology and the Toxic Substances Control Act (TSCA) often leads to claims that it lacks the authority to regulate the safety of nanomaterials. A review of the Consent Order attached to a recent Premanufacture Notice (PMN) tells a very different story.

    The Environmental Protection Agency (EPA) has made available to the public a “sanitized” Consent Order which has been attached to a PMN for multiwalled carbon nanotubes. The order requires the submitter to take several actions including conducting a 90-day inhalation study in rats.

    Other requirements include: delivering a 1-gram sample of the substance along with a Material Safety Data Sheet; provide additional material characterization data within 6 months; use of impervious gloves and chemical protective clothing; use of a NIOSH-approved full-face respirator; maintenance of certain records; distribution only to those following the same handling restrictions; and use of the substance only as specified.

    The Consent Order provided by the EPA was for a specific submission but all confidential business information regarding the specific material and the company was removed so it could be seen as an example of the requirements for PMN submissions for carbon nanotubes. Similar requirements can probably be expected on other nanomaterials identified by the agency during the Nanoscale Materials Stewardship Program.
  • Based on a review of studies on the effects of carbon nanotubes (CNTs), Friends of the Earth Australia (FoEA) is calling for a moratorium on commercial use of the nanoscale material.

    Drawing a strong association with the serious effects of asbestos due to similar fiber size, FoEA published a compendium of studies highlighting “the potential for carbon nanotubes to cause asbestos-like harm.”

    Suggesting that continued use of CNTs will cause a “repeat of the asbestos tragedy,” a moratorium is recommended until: research can demonstrate whether or not there is any safe level of exposure to them; new nanotechnology-specific regulation is introduced to protect the health of workers, the public and the environment; all nanomaterials used in the workplace and in consumer products are subject to mandatory labeling; and the public is given a meaningful role in decision making about nanotechnology governance, policy development and research priorities.

    While media coverage of the CNT study has generally been accurate, scientists were not surprised about the results. In fact, they suggest that the results of the study seem to confirm the relationship between fiber length and formation of granulomas.

    Scientists have expressed the opinion that the hazards associated with CNTs are related more to the length of the tube rather than any inherent toxicity as a nanoscale material. Researchers on the highly publicized study at issue were clear that the “study does not address whether CNTs would be able to reach the mesothelium in sufficient numbers to cause mesothelioma following inhalation exposure.”
  • Citing opinions from two scientific committees on the possible risks posed by nanomaterials, the European Commission is asking industry to submit data on nanoparticles used in cosmetics.

    In an Opinion on Safety of Nanomaterials in Cosmetic Products released in December 2007, the Scientific Committee on Consumer Products expressed concerns about the lack of information on nanomaterial hazard identification, exposure assessment, uptake, the role of physico-chemical parameters of nanoparticles determining absorption and transport across membranes in the gut and lungs, and other possible health effects.

    The Scientific Committee on Emerging and Newly-Identified Health Risks stated in June 2007 in its Opinion on the Appropriateness of the Risk Assessment Methodology in Accordance with the Technical Guidance Documents for New and Existing Substances for Assessing the Risks of Nanomaterials that current risk assessment methodologies may not be valid for nanoparticles and risk determinations may need to be made on a case-by-case basis.

    To gather additional information on nanoparticle characteristics and risk assessment methodologies, the European Commission is asking industry to voluntarily submit available data on nanoscale materials. Nanomaterials identified in the public consultation include fullerenes, titanium dioxide, zinc oxide, silicon dioxide, alumina, calcium carbonate, lipids, vitamins and cerium oxide.

    Specifically, data requested includes: chemical composition, chemical impurities, form and its flexibility, agglomeration and coalescence behavior, stability, surface reactivity biodegradability and solubility of the nanoparticles; the storage conditions of the particles prior to the manufacturing of the cosmetic product and the molecules with which the particles come into contact; the proportion of nanoparticles in the final product (in mass concentration, number concentration and surface area); other components of the final product; modification of the particles occurring within the cosmetic product during or after the manufacturing process; and the interaction between the various factors for each of the products.

    The European Commission has asked that information be submitted by December 31, 2008.
  • Over 300 people attended a public meeting held by the Food and Drug Administration (FDA) to discuss nanotechnology but many left the meeting wondering when the agency is going to have some answers rather than still asking questions.

    Setting the stage for the meeting is the FDA’s Nanotechnology Task Force Report which was released in July 2007. The report provided initial findings and recommendations including; a synopsis of the state of the science for biological interactions of nanoscale materials; analysis and recommendations for science issues; and analysis and recommendations for regulatory policy issues.

    The recent meeting included a plenary session with an FDA update on activities of the Nanotechnology Task Force followed by breakout sessions for presentations by speakers which were organized around specific product areas; Prescription Drugs; Cosmetics; and Food & Color Additives/Dietary Supplements.

    The product area which has received considerable public attention is in the area of cosmetics. In the breakout meeting presentations were made by the Personal Care Products Council, Project on Emerging Nanotechnologies, and Consumer Union. Once the presentations were completed a moderator reviewed questions posed in the Federal Register Notice and, lacking any response from attendees, closed the session.

    The other breakout sessions had significantly more participation. The food breakout session included presentations by the FDA, National Institute of Standards and Technology, BASF Corporation, George Washington University, Robin Guy Consulting, CLF Ventures, Friends of the Earth, Institute of Food Technologists, Consumer Union, Project on Emerging Nanotechnologies, and JCH Consulting.

    The Personal Care Products Council, OPS/CDER, CytImmune Sciences, Perceptive Informatics/PAREXEL, International Center for Technology Assessment, nanoTox, Consumer Union, and Intertox made presentations during the drugs breakout session.

    FDA staff asked several questions during the course of the sessions. Many participants privately questioned the length of time the FDA is taking to reach any kind of conclusions with regard to nanotechnology. The FDA approach may be deliberative and the questions to be be answered may be difficult, but the lack of transparency is troubling to many. The agency’s 2007 Sunscreen Proposed Rule is still unresolved over a year after it was proposed.
  • By many measures the Nanoscale Materials Stewardship Program (NMSP) was a success but it may not have given officials everything they need to regulate the production and use of nanomaterials. The ball is now in the Environmental Protection Agency’s (EPA) court and they are strongly considering a test rule to get what they need. Within the next few weeks the ball may be thrown back to the nanotech community.

    EPA staff is reviewing Basic Program submissions for a perspective on nearly 100 substances as well as examining the quality of the information. The agency has long contended that the information collected in the voluntary program must be sufficient to allow decision-making to be based on solid science. Officials have indicated that anything short of that goal would necessitate a Toxic Substances Control Act (TSCA) test rule which would require all producers and importers to submit risk information and test data for review.

    A test rule would specify the specific nanoscale materials subject to the rule and identify information required to satisfy regulatory officials. Materials under consideration for such a test rule include fullerenes, single- and multi-wall carbon nanotubes, nanoscale silver, zero-valent iron and nanoscale titanium dioxide. Noting the lack of submissions for nanoclays, consideration is also being given to addition of the substance to any test rule.

    Before a test rule can be promulgated the agency will review all available information and information under development. Beside NMSP submissions, the agency is reviewing information under development for 14 nanomaterials by the Organisation for Economic Co-operation and Development Working Party on Nanotechnology, the National Toxicology program (NTP) and other research programs.

    Some of the testing under consideration for the test rule includes several acute and sub-chronic mammalian toxicity tests as well as pharmacokinetic data. Several environmental and aquatic toxicity tests are also under consideration.
  • Amid skepticism over the Environmental Protection Agency’s (EPA) Nanoscale Materials Stewardship Program (NMSP), a recent NanoReg poll reveals support for the effort as an effective tool for collecting safety information on nanoscale materials.

    More than half of those taking the NanoReg poll had a positive outlook on the NMSP. With 29% indicating that it’s a great start and 24% indicating that the voluntary information collection program is a reasonable approach, most respondents seemed to feel comfortable with the EPA’s process.

    Given the outcry from non-governmental organizations on the shortcomings of the Toxic Substances Control Act (TSCA) as the key regulatory authority for regulation nanomaterials, it was revealing to note that only 9% of poll respondents indicated the need for new laws to deal with nanomaterials.

    Equally interesting is the result that showed only 10% of those taking the poll indicated the NMSP is “too little, too late.”

    The poll was not a clear-cut victory for the EPA. It did indicate some hesitance on the part of 25% of respondents who felt the information gathered through the voluntary effort wouldn’t be sufficient to learn about the potential risks of nanomaterials.

    This poll is the first to determine to overall level of public support for the NMSP and was designed to give respondents several options. The options reflected public comments by non-governmental organizations, industry members and government officials over the last few years. There were no restrictions on who was allowed to vote and anyone involved with research, regulation, production or use of nanomaterials or nano-enhanced products was encouraged to participate.
  • It’s been over a year since the Food and Drug Administration (FDA) proposed new regulations on sunscreen labels. Citing safety concerns caused by several ingredients, including nanoscale titanium dioxide, the Cancer Prevention Coalition (CPC) chided the agency for a lack of action.

    In a recent press release, the organization pointed out that the FDA has not changed its regulations to take into account the potential risks caused by nanomaterials. “Of major concern, and still ignored by the FDA, is the increasing addition to sunscreens of unlabeled atom or molecule size zinc oxide or titanium dioxide particles.”

    The group based its concerns on reports in “over two dozen scientific publications since 2003, including those by an Environmental Protection Agency research team and the International Center for Technology Assessment, [that] nanoparticles can penetrate the skin, invade blood vessels, and produce devastating distant toxic effects.”

    The organization also referred to previous petitions submitted to the FDA in 1994 and 2008 seeking a cancer warning label for feminine hygiene products containing talc.

    CPC is a coalition of leading independent experts in cancer prevention and public health, together with citizen activists and representatives of organized labor, public interest, environmental, and women's health groups.

    Based in Chicago, the organization’s stated goal is to reduce escalating cancer rates through a comprehensive strategy of outreach, public education, advocacy, and public policy initiatives to establish prevention as the nation's foremost cancer policy.
  • The Project on Emerging Nanotechnologies (PEN) has put another federal agency under the nanotechnology microscope.

    The Consumer Product Safety Commission (CPSC) is the subject of a critical report on the agency’s ability to oversee the safety of products containing nanomaterials. The author of the report, E. Marla Felcher, teaches at the Harvard University Kennedy School of Government.

    According to Felcher, “The agency lacks the budget, the statutory authority and the scientific expertise to ensure the hundreds of nanoproducts now on the market, among them baby bottle nipples, infant teething rings, paints, waxes, kitchenware and appliances, are safe. This problem only worsens as more sophisticated nanotechnology-based products begin to enter the consumer market.”

    Using the unverified PEN database of consumer products containing nanomaterials as an indicator of the magnitude of the possible impact, the report, The Consumer Product Safety Commission and Nanotechnology, draws a correlation to government oversight of nanomaterials with that of lead and phthalates. The report also correctly indicates that several other government agencies have regulatory jurisdiction over nanomaterials including the Environmental Protection Agency (EPA) and Food & Drug Administration (FDA).

    Recommendations provided by the author include some broad-based activities such as building the CPSC nanotechnology knowledge base and expertise as well as coordinating with other health and safety agencies (which they already do).

    A few of the recommendations simply presume that all nanomaterials are hazardous such as the suggestion to convene a Chronic Hazard Advisory Panel to evaluate all products containing nanomaterials that are intended for use by children. Another recommendation based on the same premise is that the CPSC be given the authority to require manufacturers to identify any nanomaterials in their products.

    The latest report is one of a series of reports critical of federal agencies and their ability to regulate the use of nanotechnology in the consumer market. Similar reports have been released about the EPA and FDA.
  • With recent completion of the Basic Program phase of the Environmental Protection Agency’s (EPA) Nanoscale Materials Stewardship Program (NMSP), some organizations are showing their support for a successful beginning of this controversial voluntary information collection program.

    In the second joint statement in support of the EPA’s NMSP, the Synthetic Organic Chemical Manufacturers Association’s Nanotechnology SME Coalition, the American Chemistry Council’s Nanotechnology Panel and the NanoBusiness Alliance “recognize and appreciate EPA’s leadership in the NMSP.”

    The initial reporting period for the Basic Program ended on July 28, 2008 and to date, submissions have been made by 22 organizations covering 93 materials. Submissions come from a diversity of companies and consortia, including larger entities, innovative “start-ups” and mid-size firms who are researching, developing, manufacturing and using nanotechnology products.

    A large proportion of the submissions were submitted by members of the three organizations showing broad support by individual companies as well as industry trade groups.

    The EPA will evaluate information submitted by the organizations and prepare a status report in the coming months. In the interim, EPA has expressed interest in continuing to accept nanomaterials submissions on a rolling basis.

    The EPA is also encouraging additional participation in the In-Depth Program. Interested parties participating in the In-Depth Program component will work with EPA and others to develop information that will help inform the EPA about potential environmental, health, and safety impacts of nanoscale materials.
  • Standards for proper characterization are an important aspect of the testing of nanomaterials for safety. An upcoming workshop will address the need to develop internationally accepted procedures and protocols.

    The Workshop on Enabling Standards for Nanomaterial Characterization will be held in Gaithersburg, MD, on October 8-9, 2008, at the National Institute of Standards and Technology (NIST) campus.

    This workshop program has several objectives: Disseminate findings from three recent interlaboratory studies based on ASTM standards (E2524, E2526, and WK8705) and using the recently released NIST nanosize gold reference materials and two PAMAM dendrimers; Assessment of current activities on standardization for nanomaterial characterization, development of nanoscale reference materials, and prioritization of standards needs for physicochemical, in vitro and in vivo characterization and risk assessment; Formation of an international network of qualified and willing testing laboratories to facilitate future interlaboratory studies and protocol development; Demonstration and deployment of prototype software for electronic development of pre-standards protocols and for management of interlaboratory studies to support standards and protocol development; Prioritization and generation of projects by the workshop participants to develop several new protocols and interlaboratory studies; and Establishment of preliminary guidelines for the operation and management of the testing laboratory network and interactive electronic portal.

    In addition to NIST, sponsors and contributors include ASTM International, U.S. Food and Drug Administration, Nanotechnology Characterization Laboratory at NCI-Frederick, National Cancer Institute, National Institute for Occupational Safety and Health, National Institute of Environmental Health Sciences and Oregon Nanoscience, and Microtechnologies Institute.
  • Much has been said about the Environmental Protection Agency’s Nanoscale Materials Stewardship Program (NMSP) but a NanoReg poll currently underway at the NanoReg News web site is the first attempt to determine the overall level of support for the program.

    The poll is scheduled to end on Friday, September 11, 2008 and is designed to give respondents several options. The options are similar to the public comments provided by non-governmental organizations, industry members and government officials over the last few years.

    There are no restrictions on who is allowed to vote and anyone involved with research, regulation, production or use of nanomaterials or nano-enhanced products is encouraged to participate.
  • In offering recommendations to the incoming administration, a former Environmental Protection Agency (EPA) official suggests sweeping changes to key chemical regulatory laws.

    In a new report by former EPA official Dr. J. Clarence (Terry) Davies, Nanotechnology Oversight: An Agenda for the Next Administration, suggestions for the new administration are offered on how to improve oversight of this new technology. “This report provides a blueprint for early action by the next White House and key regulatory agencies,” according to David Rejeski, Director of the Project on Emerging Nanotechnologies (PEN) which supported the report. The report was funded by the Pew Charitable Trust.

    Davies offers recommendations which involve increased use of existing laws and development of new regulatory approaches to “protect against potential adverse impacts of nanomaterials.”

    Under existing regulations such as the Toxic Substances Control Act (TSCA) EPA should consider all nanoscale materials as “new” so regulatory officials could require additional scrutiny of the safety of these materials according to Davies. He suggests utilization of this designation by the Food and Drug Administration (FDA) would allow for improved oversight for cosmetics, food additives and food packaging provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA).

    Recommended changes to TSCA are suggested which would allow the EPA to ignore the burden on producers and users of nanomaterials to prove the safety of the substances and would broaden the agency’s regulatory authority to require safety testing. In addition, the recommended changes would require additional justification for Confidential Business Information (CBI) claims.

    Dr. Davies, is a senior advisor to the Project on Emerging Nanotechnologies and a senior fellow at Resources for the Future. Davies also served during the first Bush Administration as Assistant Administrator for Policy, Planning and Evaluation at the EPA.
  • With a myriad of companies using nanoscale materials making antimicrobial claims, the EPA is finally recognizing the need to apply current pesticide regulations to nano-enhanced products.

    The EPA has introduced a new web page on nanotechnology pesticide issues that provides little more than an acknowledgement that new antimicrobials “intended to control pests” will be regulated under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

    While the EPA continues to take the position that FIFRA is an adequate regulatory framework for pesticides, the agency also suggests there are difficulties in assessing possible risks. According to the web site, “the special properties that make nanoscale materials of potentially great benefit also can present new challenges for risk assessment and decision-making.”

    The new page would appear to be in response to the recent petition by the International Center for Technology Assessment (CTA), a coalition of consumer, health, and environmental groups. The petition called for the agency to amend its regulations or, at the very least, clarifying that nanoscale silver is a pesticide and registration is required. In addition, the group is asked for appropriate labeling of the consumer products containing nanoscale silver even if those products are not making antimicrobial claims.

    CTA called for the EPA to classify all nanoscale pesticides as new pesticide substances which would trigger toxicity data requirements, testing, and risk assessments. The group also asked for Stop Sale, Use or Removal Orders immediately “to prohibit the sale of nano-silver products as illegal pesticide products with unapproved health benefit claims.” The agency, however, noted that not all silver products are pesticides and reiterated the need to take regulatory action only when products make an antimicrobial claim.
  • The City of Cambridge didn’t enact a regulation on nanotechnology but it will start collecting information on companies manufacturing and using nanomaterials within the city limits.

    In accepting the recommendations of the Cambridge Nanomaterials Advisory Committee, the Cambridge City Council acknowledged the “limited health effects data and the absence of a clear consensus on best practices and standards for engineered nanomaterials.”

    The Cambridge Public Health Department will now take several information-gathering steps including: Establishment of an inventory of facilities that manufacture, handle, process, or store engineered nanoscale materials in the city; Offer technical assistance to local firms and institutions in evaluating their existing health and safety plans to limit worker exposures; Offer health information to residents on products containing nanomaterials; and Sponsor public outreach events.

    The Health Department will continue to track research developments on possible health risks, track regulatory developments concerning possible health risks from various engineered nanoscale materials among state and federal agencies, and report back on new developments to the City Council every other year.

    The Advisory Committee consisted of a number of representatives from academia, industry, non-governmental organizations, Cambridge residents, and others with expertise in nanotechnology environmental, health, safety, and regulatory expertise.

    In 2006, Berkeley, CA became the first U.S. city to pass legislation on nanotechnology, requiring those handling nanomaterials in the workplace to submit toxicology reports on the materials to the city. It is also anticipated that California will propose legislation next year to regulate nanotechnology at the state level.
  • The number of companies participating in the Nanoscale Materials Stewardship Program (NMSP) jumped dramatically in the last two weeks but it’s unclear if the last-minute additions will be enough to avoid an Environmental Protection Agency (EPA) test rule.

    At least 32 companies and trade groups have agreed to participate in Basic Program of the NMSP as of July 31, 2008. Nineteen organizations have already submitted information on 90 nanoscale materials and an additional 11 organizations have agreed to submit information. Three companies have agreed to participate in the In-Depth component of the NMSP.

    The surge of submissions comes only a few days after comments on the possibility of a Section 8 rule by Jim Willis, Director the Chemical Control Division (CCD) in EPA’s Office of Pollution Prevention and Toxics. CCD is responsible for the implementation of EPA’s new and existing chemicals programs, the chemical testing program, and special projects such as the Nanoscale Materials Stewardship Program, the HPV Challenge and the PFOA Stewardship program. The EPA has the authority under the Toxic Substances Control Act (TSCA) to use the rule mechanism to obtain additional information regarding nanoscale materials and other chemical substances.

    Despite the last minute rush of submissions, the level of participation may still fall far short of the agency’s original estimates of 100-200 companies which should provide information. Willis had also indicated a desire to collect data on at least 100 nanoscale materials.

    One other area of concern for the agency is the minimal participation in the In-Depth Component of the NMSP. With only 3 companies making a commitment to participate, the EPA may be compelled to use a rule to require the development of additional data on nanoscale materials.

    The EPA invited companies that manufacture, import, process, or use nanoscale materials for commercial purposes, to join the NMSP, including those who: Manufacture or import engineered nanoscale materials; Physically or chemically modify or process an engineered nanoscale material; Physically or chemically modify or process a non-nanoscale material to create an engineered nanoscale material; or Use engineered nanoscale materials in the manufacture of a product. Others, including researchers who develop or study engineered nanoscale materials, are also invited to participate. Any participation in the program is voluntary.

    The EPA is posting all non-confidential submissions under the Nanoscale Materials Stewardship Program on a new web page as they become available.
  • The Food and Drug Administration (FDA) would like to have more information on products containing nanoscale materials and the public is being asked to provide it to them.

    The FDA is considering development of agency “guidances” and a public meeting has been scheduled for September 8, 2008 to “assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report.” The report, issued in 2007, provided recommendations on covered foods, (including dietary supplements), food and color additives (including food contact substances), animal drugs and feeds, cosmetics, human drugs and biologics, and medical devices.

    In the Federal Register Notice the FDA identify specific areas of interest to the agency and poses specific questions to be addressed at the public meeting. In addition, the FDA announced “a request for available data and information on the effects of nanoscale materials on quality, safety, and, where relevant, effectiveness of products subject to FDA oversight.”

    The meeting will include a plenary session with an FDA update on activities of the Nanotechnology Task Force followed by breakout sessions for presentations by speakers which will be organized around specific product areas at the University of Maryland Shady Grove Center/Universities in Rockville, Maryland.
  • One of the key concerns about nanomaterials is how they impact the food supply when released into the environment or deliberately applied to crops.

    A recent study shows that plants can be affected by nanomaterials in different ways. Functionalized (with poly-3-aminobenzenesulfonic acid) carbon nanotubes (CNTs) and non-functionalized CNTs were applied to six crop species (cabbage, carrot, cucumber, lettuce, onion, and tomato) in a pilot study.

    Non functionalized CNTs inhibited the root growth of tomato plants and enhanced root elongation in onion and cucumber plants. Functionalized nanotubes inhibited root elongation in lettuce. Cabbage and carrot plants were not affected by either form of nanotubes. Using scanning electron microscopy, no uptake of either form of CNTs was observed in any of the test plants.

    The pilot study, Effects of Functionalized and Non-Functionalized Single-Walled Carbon Nanotubes on Root Elongation of Select Crop Species, was conducted by researchers at Texas Tech University.
  • As Canadian regulatory officials approach nanomaterial safety, a panel of scientific experts says more information is needed.

    An expert panel appointed by the Council of Canadian Academies has concluded that too little is known to assess the overall human and environmental risks posed by the introduction of nanomaterials and nano-enhanced products into society. However, the panel did not identify any evidence that nanomaterials currently on the market in Canada present risks that cannot be addressed through available risk management strategies.

    “The panel sought to assemble the existing science, and understand what it implies about the hazards presented by nanomaterials, what risks they present to human health and our environment, and how we can best manage these risks given the current uncertainties and key gaps in knowledge,” said University of Toronto professor Pekka Sinervo, chair of the expert panel.

    The report, Small is Different: A Science Perspective on the Regulatory Challenges of the Nanoscale, was requested by Health Canada (in consultation with several other federal agencies) and prepared by a panel of 15 experts who are engaged in the creation and application of nanomaterials, assessment of the risks they may present, and public policy issues related to health and environmental regulation. The report was in response to the question, “What is the state of knowledge with respect to existing nanomaterial properties and their health and environmental risks, which could underpin regulatory perspectives on needs for research, risk assessment and surveillance?”

    The current risk assessment strategies that are used in health and environmental regulations in Canada comprise four steps: hazard identification, hazard characterization, exposure assessment and risk characterization. The application of these strategies to nanomaterials will require new ways for measuring exposure, dose and response. The report concludes that there are, at present, inadequate data to inform quantitative risk assessments on nanomaterials. At most, only qualitative risk assessments are feasible. Moreover, changes in the potential for nanomaterials to cause harm at different stages -- from production, through usage, to final disposal -- implies the need for a full, life-cycle approach to risk assessment.

    The primary mission of the Council of Canadian Academies is to provide independent, expert assessments of the science that is relevant to matters of significant public interest with the goal of informing public debate and decision making. The Council, which became operational in 2006, is supported by a founding grant from the Government of Canada but is independent from government.
  • The recent passage by the U.S. House of Representatives of the National Nanotechnology Initiative Amendments of 2008 has laid the groundwork for the U.S. Senate to continue the public dialogue on needed changes to this important program. Some of the changes could have a significant impact on the future regulation of nanotechnology in the United States.

    Senate Commerce, Science, and Transportation Committee Chairman Daniel K. Inouye (D-Hawaii) joined Senators John Kerry (D-Mass.), Olympia Snowe (R-Maine), Ted Stevens (R-Alaska), Mark Pryor (D-Ark.) and Gordon Smith (R-Ore.) to introduce the National Nanotechnology Initiative Amendments Act of 2008 (S.3274). The bill would reauthorize the National Nanotechnology Initiative (NNI) and amend aspects of the program to better prioritize research and development activities.

    Several recommended changes to the current NNI include establishment of the National Nanotechnology Advisory Panel, an independent entity which would be responsible for recommending an appropriate funding level for the Environmental, Health, and Safety (EHS) program component area and establish a subpanel focused on the societal, ethical, legal, environmental, and workforce issues related to nanotechnology.

    The bill would also require the National Nanotechnology Coordinating Office (NNCO) to provide consistent funding to federal agencies and establish a publicly available database of environmental, health, and safety projects. Like the House version of the bill, an Office of Science and Technology Policy official would be assigned the responsibility to ensure that a detailed implementation plan for EHS research is developed and executed – a plan that specifies both near-term and long term objectives, provides a timeline for achieving the near-term objectives, and identifies the funding, by objective and by agency, necessary to carry it out.

    “Developments in nanotechnology have the potential to offer a wide range of innovations in research, industry, and commercial products that will influence our daily lives,” said Senator Inouye. “At the same time, nanotechnology is still a young field, and we must be sure that any potential risks are identified, analyzed, and properly understood. This bill achieves just that by strongly encouraging diverse participation in the comprehensive study and coordinated development of environmental, health, and safety standards.”

    One interesting addition to the definitions section of the bill is the term “nanoscale” which is intended to replace the terms “atomic, molecular, and supramolecular levels.” In defining nanoscale the bill would be officially establishing the term as meaning a substance with one or more dimensions of between approximately 1 and 100 nanometers. This official designation could inevitably be used by agencies like the Environmental Protection Agency (EPA) in future regulatory decisions. The House version of the bill (H.R.5940) that was referred to the Senate contained no such new definition.

    The Senate version of the bill also requires the Comptroller General of the United States to “conduct a study of Federal codes, standards, and regulations as they pertain to the safe production, use, and disposal of engineered nanomaterials and products that embody engineered nanomaterials.” Agencies specifically mentioned in the provision include the EPA, the Food and Drug Administration, the Department of Agriculture, the Consumer Product Safety Commission, and the Occupational Safety and Health Administration. This review of regulations is required to be completed within two years.

    The NNI was established in fiscal year 2001 to coordinate Federal nanotechnology research and development.
  • Government officials have worked very hard to make the voluntary program work but the number of commitments to provide information may not be sufficient to prevent a mandatory test rule to collect and develop data on the safety of nanomaterials.

    The Environmental Protection Agency (EPA) announced the Nanoscale Materials Stewardship Program (NMSP) on January 28, 2008 to encourage companies engaged in the development and use of nanomaterials to voluntarily provide information on physical and chemical properties in addition to risk management practices. The agency needs this information to build a scientific knowledge base which will provide sufficient basis for informed regulatory decisions on nanomaterial safety.

    With only two weeks to go in the basic program component, four companies (DuPont, Office ZPI, Strem Chemicals and one Confidential Business Information company) have submitted information. Twelve companies and industry trade groups (BASF Corporation, Bayer Material Science, Dow Chemical, Evonik Degussa, General Electric, International Carbon Black Association, Nanocyl North America, Nanophase Technologies Corporation, Nantero, PPG Industries, Sasol North America, and the Synthetic Amorphous Silica and Silicate Industry Association) have made commitments to submit information at a later date.

    In an effort to support the NMSP, the SOCMA Nanotechnology SME Coalition, the American Chemistry Council’s Nanotechnology Panel and the NanoBusiness Alliance released a joint statement encouraging companies “researching, developing, manufacturing, and/or using products in the field of nanotechnology” to participate in the program.

    Industry proponents of participation in the program have long understood the ramifications of failure of the NMSP. As the joint statement indicated, “If voluntary participation in the NMSP is low, EPA may need to resort to more traditional mandatory information gathering measures that could include issuing a Toxic Substances Control Act test rule to compel the development of new data, or implement mandatory handling requirements for manufactured nanomaterials.”
  • While much of the public discussion on nanomaterial safety has centered on human health, the environmental impacts of nanotechnology are receiving a great deal of attention in the academic community.

    The University of Birmingham will be the venue for the 3rd International Conference on the Environmental Effects of Nanoparticles and Nanomaterials. The meeting on this topic follows the success of the 2nd international meeting held in London last year.

    Themes of the conference include: Chemical and physical properties of manufactured or natural nanoparticles and other nanomaterials in the environment; Fate, behavior, interaction and biogeochemistry; Toxicological, ecotoxicology and biological effects; Detection, measurement and bioassays for nanosubstances; Environmental risk assessment, life cycle analysis, modeling and human health; Environmental and industrial applications of nanotechnologies; Positive effects of nanoparticles in the environment – remediation; and Regulation, legislation, policy and public perception of new technology.

    The event is scheduled to be held September 15-16, 2008.
  • The European Commission public dialogue on the safety and environmental effects of nanomaterials is beginning to take shape.

    The Directorate-General for Health and Consumers of the European Commission has organized the 2nd Annual Nanotechnology "Safety for Success" Dialogue Workshop. The workshop, to be held in Brussels, Belgium from October 2 – 3, 2008, is intended for scientists, risk assessors, public authorities, industry, consumers, and environmental non-governmental organizations.

    As part of the recently announced European Commission public dialogue on nanotechnologies Director General Robert Madelin extended an invitation “to a frank, informal, yet structured exchange of views on the latest developments of nanotechnologies, on the best ways to insure an appropriate implementation of the legislation and on how to improve communication between stakeholders.”

    In a first step to address the concerns of nanotechnology safety the public dialogue will include a review of how the EU legislation covers nanotechnologies, publishing the review, and confirming that "current legislation covers to a large extent risks in relation to nanomaterials and that risks can be dealt with under the current legislative framework."
  • An 8-step program can be employed to limit liabilities and help the bottom line when it comes to nanomaterial safety.

    Authored by ICF International’s Deanna Lekas, the Project on Emerging Nanotechnologies’ Research Brief How to Reduce Your Firm’s Risk and Increase Revenues Related to Nanotechnology highlights several ways for producers and users of nanomaterials to reduce environmental, health, and safety risks.

    Steps outlined in the Research Brief include: 1) Focus on the Bottom Line; 2) Become or Develop a Champion Within Your Firm; 3) Incorporate Life-Cycle Thinking into Operations and Product Development; 4) Seek Information and Assistance on EHS Implementation; 5) Follow Best Practices for Worker Health and Safety Precautions; 6) Prepare for Potential Nano-Specific Regulations; 7) Increase Educational Efforts; and 8) Seek Continued Improvement.

    The brief provides an excellent framework for small companies seeking to develop a product stewardship program for their products. Such a program can have long-tem risk reduction benefits which include enhanced worker safety, an improved corporate image and greater investor interest.
  • Healthy skin would appear to provide an adequate source of protection from quantum dots but the same may not be said for skin with abrasions.

    Researchers at North Carolina State University have found that quantum dot nanoparticles can penetrate the skin if there is an abrasion, providing insight into potential workplace concerns for healthcare workers or individuals involved in the manufacturing of quantum dots or doing research on potential biomedical applications of the tiny nanoparticles.

    Researchers tested the ability of the quantum dots to penetrate rat skin at 8 and 24 hour intervals. The experiment evaluated rat skin in various stages of distress – including healthy skin, skin that had been stripped using adhesive tape and skin that had been abraded by a rough surface.

    While the study indicates that acute – or short-term – dermal exposure to quantum dots does not pose a risk of penetration (unless there is an abrasion), Dr. Nancy Monteiro-Riviere, professor of investigative dermatology and toxicology at NC State's College of Veterinary Medicine notes "there is still uncertainty on long-term exposure."

    This finding is of importance to risk assessment for nanoscale materials because it indicates that skin barrier alterations – such as wounds, scrapes, or dermatitis conditions – could affect nanoparticle penetration and that skin is a potential route of exposure and should not be overlooked.

    Although quantum dots are incredibly small, they are significantly larger than the fullerenes that Monteiro-Riviere showed in a 2007 study in Nano Letters can deeply and rapidly penetrate healthy skin when there is repetitive flexing of the skin.

    The study, Assessment of Quantum Dot Penetration into Intact, Tape-Stripped, Abraded and Flexed Rat Skin, was published in the June issue of Skin Pharmacology and Physiology.
  • The call for specific regulations on nanomaterials is gathering momentum in the European Union.

    In a recent resolution adopted by the European Trade Union Confederation (ETUC) Executive Committee, a series of demands have been made on nanotechnology development. The primary demand is that the precautionary principle be applied to nanotechnologies.

    While the European Union has taken a measured approach to the application of the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation to nanomaterials, it has always conceded that regulatory adjustments may still be in order. The ETUC is insisting that all nanomaterials produced or imported in quantities below 1 metric ton per year should be regulated by REACH.

    The resolution also asks that Chemical Agents Directive 98/24/EC be amended to require employers to implement risk reduction measures for substances “not proven to be harmless.” Mandatory training and health surveillance for workers potentially exposed to nanomaterials are also demanded as worker protection measures.

    As part of the ongoing debate over the amount of funding for nanotechnology safety research, the resolution demands that 15% of public research budgets be allocated for the health and safety aspects of nanomaterials.

    The ETUC founded in 1973, represents 82 trade union organizations in 36 European countries and 12 industry-based federations. The ETUC is recognized by the European Union, by the Council of Europe and by the European Free Trade Association as the only representative cross-sectoral trade union organization at European level. The organization claims to represent over 60 million workers through the various trade unions and social partners throughout the European Union.
  • From food containers to soap, toothpaste and socks, nanoscale silver is taking center stage as the latest weapon in the battle against harmful bacteria but its detractors are gaining in strength.

    Samsung was one of the first companies to get caught in the nanoscale silver debate but it won’t be the last. As an antimicrobial agent in washing machines, nanoscale silver’s ability to disinfect clothes would make it an obvious choice to be touted as a breakthrough technology. Instead, it got caught in the sometimes mysterious regulatory web within the Environmental Protection Agency (EPA) that controls the production and use of pesticides and other antimicrobials.

    The flip-flop the EPA did in changing its mind on the designation of nanoscale silver from a device to a pesticide exposed the soft underbelly of the Federal Insecticide, Fungicide and Rodenticide Act. If no antimicrobial claims are made it falls below the radar and no regulatory action is taken. If an antimicrobial claim is made then the EPA has may require the submission of safety data and appropriate labeling.

    Now there are hundreds of products on the market claiming to contain nanoscale silver. Since many of the companies are marketing the antimicrobial properties of these products the EPA has to take some action, right? One would think so but regulatory enforcement has been slow to come and many consumers who follow nanotechnology are wondering where the agency is on this issue. Sure, a few firms have been fined for labeling violations but what about all the others?

    Another issue on nanoscale silver is now gaining traction and it has to do with the release of this material into the environment. Originally, it was suggested that miniscule amounts of the material is released into the environment but recent research on socks containing nanoscale silver indicates that almost all of the nanomaterial may be released after just four washings.

    In addition, it has been noted that the same antimicrobial properties that are being exploited in so many consumer products may also be killing beneficial bacteria like those currently used to treat wastewater in municipal facilities. This is how the EPA came to change its mind on nanoscale silver. It was the wastewater treatment plant operators in California that brought the problem to light.

    Where will this all lead? Stay tuned!
  • Nanotechnology in food and food packaging is becoming a highly charged issue with no apparent end in sight to the controversy.

    If a proposal by Biological Farmers of Australia (BFA) is accepted by its members, cosmetics, clothing and food products will be denied organic certification. The BFA proposal is similar to the UK’s Soil Association which banned the use of man-made nanomaterials from all Soil Association certified organic products in January 2008.

    “As with all technology choices, issues of consumer safety and environmental protection need to be balanced, assessing the ‘need’ for the technology in the first instance. At this point the organic industry is taking the view that there is no confirmed need for nanotechnologies. There is noted divergence of views within the scientific community on safety and efficacy claims which impact both consumers and manufacturers” said Dr. Andrew Monk, BFA Standards Chair.

    Even though there have been several reports suggesting that nanoparticles in sunscreen are not toxic, the use of nanoscale materials in food presents a dilemma for the food industry. Advancements in food technology and packaging in recent years has raised fears amid concerns about the potential for exposure to nanomaterials and their potential long-term health impacts.
  • The issue of nanotechnology safety has been elevated in recent days in the United States and Europe.

    While the U.S. House of Representatives passed legislation reauthorizing the National Nanotechnology Initiative, funding for safety research on nanomaterials became a high-profile topic of discussion. Across the globe this issue has become critical to companies bringing new nano-enhanced products into the marketplace and now the European Commission (EC) is making sure that everyone has a chance to weigh in on the issue.

    In a recent press release several officials took the opportunity to highlight the need to balance the benefits of nanotechnology with the need to be sure the new products are safe for the public.

    Commission Vice-President Günter Verheugen, responsible for Enterprise and Industry Policy, said “A reliable and stable regulatory framework is essential for enabling the EU’s industry to fully exploit the advances of nanotechnologies. With the right structures in place they will boost innovation and contribute to growth, employment creation and competitiveness.”

    Commissioner Stavros Dimas, responsible for Environment Policy, said “The regulatory challenge is to ensure that society benefits from novel applications of nanotechnologies, while ensuring a high level of protection of health, safety and the environment and thereby fully applying the precautionary principle.”

    Commissioner Androulla Vassiliou, responsible for Health, said "In today's Europe, nanotechnologies must be developed in a safe, integrated and responsible way, involving all stakeholders so that new applications can result in real benefits for EU citizens in the area of health."

    Employment and Social Affairs Commissioner Vladimir Špidla added that "Nanotechnologies hold out exciting opportunities for creating new jobs in Europe, but we must make sure that any potential risks to workers' health and safety are properly addressed in the relevant EU workers protection legislation."

    The EC plays two key roles in this debate. Not only is it responsible for setting regulatory policy, the EC also provides funding for research. The total amount dedicated to nanotechnologies under the 6th Framework Programme for research was €1.4 billion, with a further €0.6 billion already allocated in 2007, the first year of the 7th Framework Programme for research and development for 2007-2013.

    As a next step, the EC will “also engage in an open dialogue with citizens and stakeholders at large to accompany the correct application of existing legislation to the new products arriving on the market.”
  • Those who thought the exemption of carbon and graphite would allow carbon nanotubes to fly under the radar in Europe better think again!

    In the first European Commission (EC) proposal to amend the Registration, Evaluation & Authorization of Chemicals (REACH) program, carbon and graphite would no longer be exempt from the requirement to submit safety data. REACH requires industry to provide safety data on chemical substances prior to the substances entering the market.

    The ultimate effects of the proposal create a hazy landscape for traditional forms of carbon but would seem to open the door to an increased requirement for data on the properties of novel materials like carbon nanotubes. The recent reports on a possible correlation between carbon nanotubes and cancer will likely add credence to the proposal and provide sufficient momentum to approve the decision.

    Carbon nanotubes have come under scrutiny from several areas of the regulatory community as well including the decision by the U.S. Environmental Protection Agency (EPA) to require 90-day inhalation studies as a requirement for approval in the Premanufacture Notice process. At least seven companies have made such a submission for carbon nanotubes and the EPA has been consistent in requiring the study.

    The EC proposal is expected to be approved within the next three months despite the misgivings of European Union member countries that removal of the exemption would impact other forms of carbon and graphite.
  • Over 500,000 people die from cancer each year and billions of dollars are spent on research into the causes. Now an international review group has been asked to examine the potential environmental effects of carbon nanotubes (CNTs) as a human carcinogen.

    The International Agency for Research on Cancer (IARC), part of the World Health Organization, received three nominations to review CNTs for a future IARC Monograph. The documents are intended to provide “critical reviews and evaluations of evidence on the carcinogenicity of a wide range of human exposures” as a first step in cancer prevention.

    The Preamble to the Monographs indicate the reviews “represent the first step in carcinogen risk assessment, which involves examination of all relevant information in order to assess the strength of the available evidence that an agent could alter the age-specific incidence of cancer in humans. The Monographs may also indicate where additional research efforts are needed, specifically when data immediately relevant to an evaluation are not available.”

    Nominations were submitted by David Coggon of the MRC Epidemiology Resource Centre at the University of Southampton in the UK, Jennifer Sass of the Natural Resources Defense Council, and Paul Schulte of the U.S. National Institute for Occupational Safety and Health. In each case the nominations were accompanied by a public health reason for IARC to undertake the review. The most common reasons cited include the increase in products available to the public, increased potential for exposure, and preliminary evidence that CNTs could pose a cancer risk.

    A detailed list of all nominations is available in the document, Nominations of Agents for Future IARC Review. An advisory group will review the nominations and make recommendations for those substances that should receive a high priority for further review.
  • Worker safety has garnered much of the attention surrounding the potential risks associated with nanoscale materials. A recently-published article in the Journal of Occupational and Environmental Medicine (JOEM) presents occupational health surveillance options available for workers potentially exposed to engineered nanoparticles.

    Researchers from the National Institute for Occupational Safety and Health (NIOSH), in collaboration with ENVIRON International Corporation have authored the article, Options for Occupational Health Surveillance of Workers Potentially Exposed to Engineered Nanoparticles: State of the Science. The lead author, Dr. Paul Schulte, Director of the Education and Information Division, has been leading the NIOSH effort to promote safe handling of nanomaterials in the workplace.

    In December, NIOSH released the Current Intelligence Bulletin, Interim Guidance for the Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles, for public comment. One option mentioned in the Bulletin for consideration is the utility of exposure registries, which the JOEM article discusses as well.

    In the December guidance document, NIOSH acknowledged the lack of sufficient evidence necessary to recommend medical surveillance, recommended taking measures to control exposure, conducting hazard surveillance, and using established surveillance practices such as frequency of adverse respiratory effects, since non-specific test could have negative consequences.

    In the JOEM article, the core message is that employers have a range of options in implementing an occupational surveillance system. Options range on a continuum from no action specific to nano workers to targeted medical testing. Intermediate options include documenting the presence of engineered nanomaterials and identifying potentially exposed workers.

    If employers take preliminary steps toward occupational health surveillance, the result could be a win-win situation for the employer and employee. Establishing national or even international exposure registries could provide useful information about who is working with what materials, when and where in a facility – which could be used to look for new or perceived hazards.

    The registry also provides a mechanism for feedback to employees. The employee would feel reassured that the employer is taking action to prevent or eliminate exposure to engineered nanoparticles. Additionally, with more information over time, such a registry, or registries, could provide a cohort for future epidemiological studies. At the same time, the employer benefits from an accurately constructed database of information if litigation or regulations should arise after further research about the potential risks of nanomaterials.

    Health surveillance could clearly be a transparent, proactive risk management measure for all stakeholders in the discussion about potential nanomaterial environmental and public health risks.
  • Not all voluntary information collection programs are created equal and the UK’s program is an excellent example.

    When the U.S. EPA initiated its Nanoscale Materials Stewardship Program (NMSP) it looked at other voluntary programs to see what was working and what wasn’t. The UK’s Department for Environment, Food, and Rural Affairs (DEFRA) Voluntary Reporting Scheme (VRS) set a two-year deadline for submissions. The VRS was very slow in receiving submissions and this was attributed to the lengthy time frame. Thus, the EPA’s decision to establish a 6-month deadline for the initial phase of the NMSP.

    When the VRS began it quickly received several submissions but the lack of any new submissions in some time should set off alarm bells within DEFRA. According to The UK Voluntary Reporting Scheme for Engineered Nanoscale Materials: Sixth Quarterly Report, no new submissions have been received since the publication of the last report in December 2007. While the number of nanotechnology-related companies is probably a much smaller universe in the UK as opposed to the U.S., one can only wonder why DEFRA has yet to make any program adjustments to encourage submissions. They have developed guidance and offered assistance in the form of telephone advice and site visits but clearly more needs to be done for the VRS to be considered a success.
  • For some companies, the thought of conducting safety testing on nanomaterials can seem an overwhelming concept. Who can be blamed given the technical hurdles and anticipated cost?

    Established in 2006, the Organisation for Economic Co-operation and Development’s (OECD) Working Party on Manufactured Nanomaterials (WPMN) has established an ambitious goal to test 14 nanomaterials including fullerenes, single-walled carbon nanotubes, multi-walled carbon nanotubes, silver nanoparticles, iron particles, carbon black, titanium dioxide, aluminum oxide, cerium oxide, zinc oxide, silicon dioxide, polystyrene, dendrimers and nanoclays.

    The list of endpoints for the research reflects an effort to develop a comprehensive dossier for each nanomaterial which will describe basic characterization, fate, ecotoxicity, and mammalian toxicity information.

    In a Series on the Safety of Manufactured Nanomaterials, the WPMN recently published a List of Manufactured Nanomaterials and List of Endpoints for Phase One of the Organisation for Economic Co-operation and Development Testing Programme. According to the document, this means the WPMN has completed the first of two stages planned to complete the project.

    The first stage included the development of a list of representative manufactured nanomaterials now or soon to be in commerce and a list of endpoints for the hazard assessment of those nanomaterials. The second stage will involve the actual testing of the selected manufactured nanomaterials using the initial set of endpoints.

    The OECD is an intergovernmental organization of industrialized countries in Europe, North America, the Pacific Region, and the Asia Region. Several OECD countries have agreed to sponsor the nanomaterial safety testing program.
  • The problem of understanding the level of nanotechnology environmental, health and safety (EHS) research should be resolved with the assignment of a senior White House official to monitor the federal government’s efforts.

    The passage by the U.S. House of Representatives of National Nanotechnology Initiative Amendments of 2008 requires the Office of Science and Technology Policy to assign an Associate Director as Coordinator for Societal Dimensions of Nanotechnology. The Coordinator will be responsible for ensuring that a research plan for EHS Research activities is developed, updated, and implemented.

    Congressional hearings on reauthorization of the National Nanotechnology Initiative (NNI) provided a forum for critics of the successful program to address the amount of funding dedicated to nanotechnology EHS research.

    H.R. 5940 assigns responsibility to a senior White House official to ensure that a detailed implementation plan for EHS research is developed and executed – a plan that specifies both near-term and long term objectives, provides a timeline for achieving the near-term objectives, and identifies the funding, by objective and by agency, necessary to carry it out. The legislation also requires the plan to be responsive to recommendations from the NNI external advisory committee and requires the development of a publicly accessible database containing every EHS research project supported under the NNI.

    “The promise of nanotechnology is enormous, but potential downsides need to be addressed from the beginning in a thorough, transparent process,” said Chairman Bart Gordon (D-TN). “The federal interagency nanotechnology research program has not yet put in place a well designed, adequately funded, and effectively executed research program focused on the environmental and safety aspects of nanotechnology. H.R. 5940 addresses this deficiency by requiring that a research plan, with detailed objectives and funding targets, be developed and quickly implemented.”

    The Coordinator will also be required to encourage participating agencies to “allocate the level of resources and management attention necessary to ensure that the ethical, legal, environmental, and other appropriate societal concerns related to nanotechnology, including human health concerns, are addressed.”

    Critics may only be partially satisfied with this improvement to the NNI since the requested 10% funding requirement for EHS funding was dropped in favor of an allocation roughly half that amount.
  • The Environmental Protection Agency (EPA) continues to work hard to achieve success for the Nanoscale Materials Stewardship Program (NMSP).

    Speaking directly to nanotechnology scientists and business leaders at Nanotech 2008, the Environmental Protection Agency described the NMSP and they were available to answer questions about participation in the voluntary information-submission program. Several meeting participants asked for additional information on the program and they applauded the agency’s effort to gather as much scientific information as possible on the properties of nanoscale materials.

    The EPA Chemical Control Division’s Jim Alwood provided details on the type of information the agency is seeking and he gave an update on commitments. As of the day of his talk, there were 12 companies committed to provide information under the Basic Program with two already having submitted their information to the agency. Shaun Clancy of Evonik Degussa Corporation also made a presentation indicating his company’s willingness to participate and encouraged others to do the same.

    EPA officials have indicated that if there are not an adequate number of submissions or if the submissions do not represent a significant number of nanomaterials then a data call-in may be needed. However, the agency has also been informed by several companies and trade groups that additional submissions and commitments can be expected before the July 28, 2008 deadline.

    One other area the agency is keeping a close eye on is the number of companies making a commitment to the In-Depth portion of the program. In this portion of the voluntary program, companies have been asked to sponsor data development efforts for a particular nanoscale material. Thus far there have been no commitments to the In-Depth program.
  • After months of hearings, and a few disappointments, the National Nanotechnology Initiative (NNI) is on the verge of reauthorization.

    While there was probably never any doubt that the NNI would be reauthorized, the research strategy for environmental, health and safety (EHS) became a very hot topic. With many calling for the NNI to develop a strategy with priorities for identifying research gaps and specific research to fill the gaps, the reauthorization hearings became a venue for discussion of NNI progress on the issue.

    Another key area of debate centered on the amount of funding in the NNI budget to conduct specific EHS research. Since mechanisms were not set up at an early stage to track EHS research spending, it was difficult for government officials to determine the actual spending in this area. This ultimately led to a call by non-governmental organizations and many within industry to allocate at least 10% of NNI funding to EHS research.

    By the time congress completed its mark-up sessions for the reauthorization bill, the 10% requirement was long gone and the final estimate for EHS research will be approximately $76 million. The U.S. House of Representatives is expected to pass H.R. 5940 in the first week of June.
  • A law group in Canada has been tracking government efforts to establish a regulatory framework for nanotechnology and their recommendations on the framework echo those of many others across the globe.

    The Canadian Institute for Environmental Law and Policy (CIELAP) recently released its Update on a Framework for Canadian Nanotechnology Policy: A Second Discussion Paper which has refined its approach to develop four broad strategic priorities. These strategies were originally part of twelve topic areas discussed at its second workshop on nanotechnology policy, a year after its first workshop on the topic in early 2007.

    The four key priorities for government identified by CIELAP includes: 1) Maintaining a sense of great urgency and a commitment to making recommended policy initiatives happen very quickly; 2) Increasing scientific research and addressing technical issues, along with building overall nano-related policy capacity within government; 3) designating an institutional centre within government for overall policy leadership and coordination; and 4) developing a public engagement strategy with a strong commitment to government openness and transparency.

    CIELAP’s paper provides seven timeline benchmarks for its recommendations to government. These include: A Canadian inventory of nanotechnology activities and products (by May 2009); Worker safety and public health guidelines for research and industry (by August 2009); The banning of nanomaterials in food and some food packaging (by November 2009); and Mandatory labeling of nanomaterials in cosmetics, personal care products, and cleaning agents (by May 2010).

    Founded in 1970, as the Canadian Environmental Law Research Foundation (CELRF), the Canadian Institute for Environmental Law and Policy is an independent, not-for-profit professional research and educational institute committed to environmental law and policy analysis and reform.
  • The recent focus on carbon nanotube toxicity has been the length of the tube and a possible relationship to asbestos-like toxicity. It's great for headlines but what is the reality?

    Using four different samples of Multiwalled Carbon Nanotubes (MWCNTs) and three different control particles, researchers have demonstrated than longer tubes can exhibit a response similar to asbestos fibers. Using female C57Bl mice, the carbon nanotubes (CNTs) were injected in a 0.5% sterile saline solution into the peritoneal cavity (the peritoneum is the serous membrane that forms the lining of the abdominal cavity).

    Interestingly, while much of the media coverage on this particular study highlighted the asbestos connection, scientists are not surprised about the results. In fact, they suggest that the results of the study seem to confirm the relationship between fiber length and formation of granulomas (A granuloma is a small area of inflammation due to tissue injury.).

    Researchers in this particular study expressed similar opinions. "Our data demonstrate that asbestos-like pathogenic behaviour associated with CNTs conforms to a structure activity relationship based on length, to which asbestos and other pathogenic fibres conform."ť This would seem to imply that the hazards associated with CNTs is related more to the length of the tube rather than any inherent toxicity as a nanoscale material.

    In a further blow to the asbestos hysteria, researchers go on to say that "our study does not address whether CNTs would be able to reach the mesothelium in sufficient numbers to cause mesothelioma following inhalation exposure."ť Mesothelioma is a form of cancer that is almost always caused by previous exposure to asbestos.

    The study, Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot study, was published in the May online version of Nature Nanotechnology.
  • A new article on research examining the toxicity of carbon nanotubes has recently been released. Adding to the science of nanoparticle characteristics is informative but what does the study really mean?

    The study, Raw Single-Wall Carbon Nanotubes Induce Oxidative Stress and Activate MAPKs, AP-1, NF-ÎşB, and Akt in Normal and Malignant Human Mesothelial Cells was supported by the National Institute for Occupational Safety and Health, Morgantown, WV.

    Since exposure to asbestos is the primary cause of malignant mesothelioma, mesothelial cells were exposed to single-wall carbon nanotubes (SWCNTs) to determine if the material caused any molecular changes to the cells that would be similar to the changes that would be expected with asbestos fibers.

    Using SWCNTs provided by the National Institute of Standards and Technology (NIST), researchers demonstrated enhanced DNA damage and increased cell death among several adverse effects during the course of the study.

    Researchers concluded that the cellular and molecular findings suggest that SWCNTs can cause potentially adverse cellular responses in mesothelial cells through activation of molecular signaling associated with oxidative stress, which is of sufficient significance to warrant in vivo animal exposure studies.
  • While much of the discussion on the safety of nanomaterials has focused on human health, researchers are taking a closer look at their environmental fate.

    Researchers from the School of Civil and Environmental Engineering at the Georgia Institute of Technology are examining the ability of carbon-based nanoparticles to be transported in aqueous environments.

    Using C60 (fullerenes), the research team filled glass columns with either glass microbeads or sand, and saturated the columns with water. They then sent a "pulse" of water containing C60 nanoparticles through the columns, followed by additional water containing no nanoparticles.

    They measured the quantity of nanoparticles emerging from the columns and analyzed the sand and glass beads to observe the quantity of C60 retained there. They also extracted the contents of the columns to measure the distribution of retained nanoparticles.

    “In sand, we saw a uniform distribution of the nanoparticles throughout the column, which suggests that under the circumstances we examined, there is a limited retention capability due to filtration,” explained Professor Kurt Pennell. “Once that capacity is reached, the particles will pass through until they are retained by other grains of soil or sand.”

    Study results indicate that subtle differences in water and soil conditions can significantly impact the ability of nanoparticles to migrate or be retained in filtration media.
  • How valuable would it be to have a tool to predict the impact of engineered nanoparticles on biological systems? Experts from around the world gathered in a collaborative effort to determine what it would take to create such a tool.

    More than 70 experts from academia, industry, government agencies, non-governmental organizations and 13 countries worked together to strategize and formulate a plan to develop a set of research needs to assess potential nanotechnology risks. The experts met in January 2007 in Bethesda, Maryland and in Rüschlikon, Switzerland in June 2007.

    The goal of the workshops was to “develop a framework for predicting the interactions between engineered nanoparticles and biological systems at the molecular level so that biocompatible nanomaterials can be developed and applied safely.”

    “Our ‘grand challenge’ – producing computational models that predict interactions of engineered nanoparticles with organisms – will take some time, perhaps 10 years,” said Dr. Vicki L. Colvin, Executive Director of the International Council on Nanotechnology (ICON) and professor of chemistry and chemical engineering at Rice University. “But the systematic approach taken in these workshops, of breaking the big challenge into component areas, will provide a solid foundation for further research, enable risk management and guide commercial development.”

    The report on the workshops, Towards Predicting Nano-Biointeractions: An International Assessment of Nanotechnology Environment, Health and Safety Research Needs, identified 26 research needs by participants to predict nano-biointeractions and six research needs for risk assessment. In addition, participants “outlined two-, five- and ten-year goals for producing tools to help all stakeholders characterize the risks of emerging nanotechnologies.”

    The workshops were hosted by the U.S. National Institutes of Health and the Swiss Reinsurance Company and funded by a National Science Foundation grant to ICON.
  • While much is made of the ongoing nanotechnology human health and environmental safety research programs in the United States, several other countries have joined together to do some nanomaterial testing of their own.

    Ten countries belonging to the Organisation for Economic Co-operation and Development (OECD) are in the process of establishing a testing program for at least ten nanomaterials. The countries, part of the OECD Working Party on Nanomaterials, expect to spend about $20 million to test nanomaterials over the next two years.

    Selected nanomaterials will be tested for their physical-chemical properties, as well as environmental degradation, environmental toxicology and mammalian toxicology.

    Initial sponsorship commitments have been made by the United States, United Kingdom and Japan to test fullerenes, single- and multi-wall carbon nanotubes, and cerium oxide.

    By early next year, “dossier development plans” will be produced to produce a more detailed approach to the testing program even though some testing has already begun on fullerenes and single-wall carbon nanotubes.
  • For almost two years the Environmental Protection Agency (EPA) has had the opportunity to clarify the status of nanoscale silver but, publicly at least, did not. Now, a legal petition calling on the agency to act may give them a perfect opportunity.

    The International Center for Technology Assessment (CTA) is leading a coalition of consumer, health, and environmental groups to try to force the EPA to initiate a series of enforcement actions against companies producing consumer products using nanoscale silver as an antimicrobial agent.

    According to the petitioners, more than 260 consumer products are currently on the market claiming to use nanoscale silver. The products include several cleaning products, children’s toys, food storage containers, clothing, personal care products, refrigerators, washing machines, computer hardware, and health drink supplements.

    The coalition is calling for the agency to amend its regulations, or, at the very least, clarify that nanoscale silver is a pesticide and registration is required. In addition, the group is asking for appropriate labeling of the consumer products with nanoscale silver even if those products are not making antimicrobial claims.

    In going one step further, the coalition would like the EPA to classify all nano-pesticides as new pesticide substances which would trigger toxicity data requirements, testing, and risk assessments.

    Perhaps the most onerous aspect of the petition is a call for Stop Sale, Use or Removal Orders immediately “to prohibit the sale of nano-silver products as illegal pesticide products with unapproved health benefit claims.”

    Privately, EPA staff has indicated that some action may need to be taken even if it is not everything sought in the petition. With the proliferation of new products making antimicrobial claims using nanoscale silver, it will be hard for the agency to justify not taking any action at all.

    Recently, fines were levied against ATEN Technology of Irvine, California for selling unregistered pesticides and making unproven claims about their effectiveness for a wireless laser mouse, laser travel mouse, and wireless keyboard using nanoscale silver. The company reached a settlement with the EPA to pay a fine of $208,000.

    The coalition submitting the petition also includes the Center for Food Safety, Beyond Pesticides, Friends of the Earth, Greenpeace, ETC Group, Center for Environmental Health, Silicon Valley Toxics Coalition, Institute for Agriculture and Trade Policy, Clean Production Action, Food and Water Watch, the Loka Institute, the Center for Study of Responsive Law, and Consumers Union.

    The EPA has 90 days to respond to the petition. Even if the agency rejects the notion that nanoscale silver is a new pesticide substance, the agency will probably take action on the labeling claims. Fines and orders to stop making antimicrobial claims will probably be the primary enforcement action taken.
  • Congress had an opportunity to end the debate on funding for nanotechnology environmental, heath, and safety (EHS) research but it now looks like that’s not going to happen any time soon.

    The U.S. House of Representatives and Senate have held hearings recently on the National Nanotechnology Initiative Amendments Act of 2008 and a key issue addressed by witnesses was the amount of funding for EHS research. Much of the debate on research has centered on development and prioritization of appropriate strategies. The strategies are needed to establish priorities based on the greatest need for information on the physical-chemical properties, toxicological properties and effects of nanoscale materials.

    The 2009 budget put forth by President Bush for the National Nanotechnology Initiative (NNI) is $1.53 billion with just over $76 million allocated for the EHS budget. An early version of the bill to reauthorize the NNI called for the allocation of 10% of the total budget for EHS research but a recent markup session resulted in removal of the provision.

    Federal officials have had difficulty in establishing an accurate number on the current level of funding for nanotechnology EHS research range. However, Dr. Clayton Teague, Director of the National Nanotechnology Coordination Office, testified in a recent hearing that the National Nanotechnology Initiative funded approximately $58.6 in EHS research in FY 2008. This is in sharp contrast with the Project on Emerging Nanotechnologies’ estimate of only $13 million.

    Several non-governmental organizations and industry groups have called for both the 10% funding level for EHS research and establishment of an appropriate strategy to address the gaps in current research.

    To satisfy one of those concerns, the bill, H.R. 5940, requires the Office of Science and Technology Policy to assign an Associate Director as Coordinator for Societal Dimensions of Nanotechnology. The Coordinator will be responsible for ensuring that a research plan for EHS Research activities is developed, updated, and implemented.

    In addition, the Coordinator will encourage participating agencies to “allocate the level of resources and management attention necessary to ensure that the ethical, legal, environmental, and other appropriate societal concerns related to nanotechnology, including human health concerns, are addressed.”

    Research strategies have been made public from the NNI, the National Institute for Occupational Safety and Health (NIOSH), and the Environmental Protection Agency (EPA). These strategies received a variety of comments with the latest concerning criticism of the EPA’s Draft Nanomaterial Research Strategy.

    Peer reviewers commented that the agency’s strategy was developed to rationalize current research rather than focus on gaps in current research as a basis for development of priorities for additional research.

    The addition of a coordinator for nanotechnology EHS research will probably satisfy critics who have cited the need for a central authority to monitor research efforts. However, as long as debate over an appropriate research strategy continues, critics will continue to call for additional funding for EHS research.
  • When you hear “Let’s get it right the first time” what does it mean to you? The ethics of nanotechnology is a very complex matter and a new anthology attempts to put the matter into perspective.

    The anthology, Nanotechnology & Society: Current and Emerging Ethical Issues, is a collection of papers released by The Nanoethics Group which addresses many of the ethical and social issues of nanotechnology.

    “While there are also more distant and speculative issues in nanoethics – and we’ve touched upon some of them in our previous work -- it is important to also have a single volume focused on the more immediate problems facing nanotechnology, especially as policymakers and industry are interested in these issues first and foremost,” said Patrick Lin, Ph.D., director for The Nanoethics Group and visiting assistant professor at California Polytechnic State University (Cal Poly, San Luis Obispo).

    The volume is co-edited by Fritz Allhoff (Western Michigan University) and Patrick Lin (Cal Poly, SLO; Dartmouth College), and it presents papers by notable names in nanotechnology and nanoethics, including: Jean-Pierre Dupuy (Stanford), Paul Thompson (Michigan State University), Arthur Zucker (Ohio University), David Berube (North Carolina State University), Thomas Powers (University of Delaware), Ashley Shew (Virginia Tech), Jeroen van den Hoven (Delft University of Technology, Netherlands), Drew Harris (Graves Dougherty Hearon & Moody), Raj Bawa (Bawa Biotechnology Consulting LLP), Summer Johnson (Albany Medical College), Jason Robert (Arizona State University), and Joachim Schummer (Darmstadt University of Technology, Germany). Organizations such as Canada’s Commission de l'Éthique de la Science et de la Technologie, European Group on Ethics in Science and New Technologies, Meridian Institute, and Woodrow Wilson International Center for Scholars also contributed papers.

    Based at California Polytechnic State University (Cal Poly, San Luis Obispo), The Nanoethics Group is a non-partisan research organization formed to study nanotechnology’s impact on society and related ethical issues.
  • How much is really being spent on nanotechnology safety research? Depending on whom you are listening to, funding for risk research in Europe may be outpacing spending in the U.S.

    An analysis by the Project on Emerging Nanotechnologies (PEN) suggests that U.S. officials may be overstating investments in risk research. The analysis of the National Nanotechnology Initiative (NNI) estimate of $37.7 million invested in 2006 revealed that only $13 million was invested in projects “highly relevant to addressing possible risks.”

    According to PEN Chief Science Advisor Dr. Andrew Maynard, “It appears the U.S. is guilty of wishful thinking in its assessment of research that will lead to the development of safe nanotechnologies. Both the U.S. government figure and the results of the PEN assessment show that less than 3 percent of the $1.4 billion federal nanotechnology research budget was spent on environment, health and safety research.”

    The Project on Emerging Nanotechnologies study evaluated all of the research projects listed in the NNI research strategy released last February and classified each project according to their relevance to addressing potential environmental, health or safety hazards. Each project was determined to be highly relevant, substantially relevant, has some relevance or marginally relevant.

    In 2006, European countries invested nearly $24 million in similar nanotech risk focused projects, according to publicly available data. In a recent congressional hearing, Dr Maynard called for a reorganization of the federal nanotechnology risk research strategy to allow for a “top-down” approach to risk research. He also suggested that the funding level for this research should be approximately 10 percent of the federal nanotechnology research budget.
  • Challenged with trying to be transparent about product safety, Swiss retailers have banded together to adopt a code of conduct for handling nanotechnology in consumer products.

    The Swiss Retailers Organisation (IG DHS) is taking the lead on behalf of major retailers to force producers of consumer products containing nanomaterials to provide information on environmental and health risks.

    According to information provided by IG DHS, several major retailers that have signed on to the Code of Conduct: Nanotechnologies “are expected to require producers and suppliers to provide all the information necessary for assessing the safety of a product. This includes, for instance, the technical specifications, data on any potential risk to human beings, animals or the environment, and information on the added value of a nanoproduct in comparison with its conventionally produced counterpart.” The Code “obliges retailers to take a responsible approach to nanotechnology products. Product safety comes first: only products that, according to the present state of knowledge and in the light of their probable use, are not associated with any health or environmental risks.”

    An important aspect of the new Code is a call by the retailers to label products containing “nanotechnology-based components or modes of action.” This new approach by retailers will enhance the argument by consumer advocates that product labeling should be mandatory and given the European proclivity for the Precautionary Principle, this action will certainly add fuel to the fire.
  • If you have questions about the use of nanotechnology in food, don’t look to the major food companies for any answers.

    Nanotechnology is not only bringing us better tennis balls and sunscreen but is increasingly found in food and food products. According to a recent report by Friends of the Earth, Out of the Laboratory and On to Our Plates: Nanotechnology in Food & Agriculture, over 100 food products are already on supermarket shelves.

    Nanomaterials can be found in food packaging, cooking equipment, food storage containers, beverages, cooking oil, additives, health supplements and refrigerators.

    One of the major concerns presented by non-governmental organizations like Friends of the Earth is that untested nanomaterials are in food and food products without the knowledge of consumers. Given the information about these materials in food products, it is assumed that consumers may choose to avoid these nano-enhanced products. Clearly, this concerns food manufacturers and they have apparently decided to remain silent on the issue.

    Trade groups such as the Institute of Food Technologists have begun to address the issue through conferences and workshops but large food industry groups such as the Grocery Manufacturers/Food Products Association have stayed out of the public dialogue on nanotechnology.

    Those that remember the genetically-modified food outcry a few years ago cringe at the thought of revisiting those uncomfortable days. Perhaps this is the reason the food industry is keeping their heads down but leaders in the industry would do well to enter the debate and begin to lift the veil of public concern before the issue of food safety begins to spin out of control once again.
  • A lot has been said in recent years about the need for additional federal funding for nanotechnology safety research and now Congress has brought the issue front and center as part of the reauthorization of the National Nanotechnology Initiative (NNI).

    The latest salvo on the need for safety research was delivered by Senator John Kerry as he presided over the Commerce Subcommittee hearing on reauthorization. “We also have a responsibility to make sure we’re dedicating sufficient resources toward researching the environmental health and safety (EHS) impacts of these particles” said Kerry in a prepared statement.

    According to the GAO, just 3 percent of the $1.3 billion designated for the NNI in 2006 was used to further EHS research. With that fact in mind, Kerry indicated that “funding for EHS research will be a top priority as we move forward with this reauthorization process.”

    In U.S. House of Representatives Science and Technology Committee hearing, committee Chairman Bart Gordon echoed similar concerns over the need for more safety research.

    "Although the NNI has from its beginnings realized the need to include activities for increasing understanding of the environmental and safety aspects of nanotechnology, it has been slow to put in place a well designed, adequately funded, and effectively executed research program to address this issue," added Gordon.

    "The environmental and safety component of NNI must be improved by quickly developing and implementing a strategic research plan that specifies near-term and long-term goals, sets milestones and timeframes for meeting near-term goals, clarifies agencies’ roles in implementing the plan, and allocates sufficient resources to accomplish the goals."

    The National Nanotechnology Initiative was originally authorized on December 3, 2003.
  • A group born out of concern for groundwater contamination caused by the semiconductor and biotech industries in the early ‘80s is taking on nanotechnology firms with an eye toward avoiding mistakes of the past.

    The Silicon Valley Toxics Coalition (SVTC) released a report that addresses the potential dangers of the rapidly expanding nanotechnology industry. The report, Regulating Emerging Technologies in Silicon Valley and Beyond: Lessons from 1981 Chemical Spills in the Electronics Industry and Implications for Regulating Nanotechnology, calls for new comprehensive state and federal regulatory policies that adequately address the potential hazards posed by nanotechnology.

    “The current landscape with respect to environmental knowledge about nanotechnology is eerily similar to the landscape of the 60s for basic chemicals,” said Sheila Davis, Executive Director of SVTC. “Landmark environmental acts passed in the 70s and 80s are out dated and do not apply to nanotech. We also lack monitoring and detection technology, and cleanup practices have not been established.”

    This report presents a case study of the regulatory landscape faced by Santa Clara County in the 1980s and draws parallels to today’s health and environmental regulations for nanotechnology. The paper concludes by outlining recommendations for policy reform based on closing existing gaps in data, technology, and safety.

    While instructive, the report falls short on specifics when making its case for new regulations. For example, the Toxic Substances Control Act (TSCA) is described as a 40-year old framework that “has not significantly changed since 1976, and it is clearly in need of modernization to address emerging new materials and environmental issues, especially those related to nanotechnology.”

    No new evidence of TSCA’s shortcomings is provided other than the implication that the law is outdated and the document simply refers to other reports on the subject by the Project on Emerging Nanotechnologies and the American Bar Association.
  • Forty German and Swiss firms working with nanomaterials were surveyed to evaluate industry risk assessment practices. It will come as a surprise to no one that conclusions are difficult to come by.

    Twenty-six (65%) of the companies surveyed did not perform and risk assessment of their nanomaterials while thirteen companies performed risk assessments sometimes or always. Fate of nanomaterials in the use and disposal stage received little attention by industry and the majority of companies did not foresee unintentional release of nanomaterials throughout the life cycle.

    When asked about nanomaterial characterization at each of the companies in the survey, it was found that the nanomaterials in this sample exhibited such a diversity of properties that a categorization according to risk and material issues could not be made.

    The survey, Risk Assessment of Engineered Nanomaterials: A Survey of Industrial Approaches, was published in Environmental Science & Technology.

    Authors of the article on the survey suggest the development of risk and safety decision frameworks seems necessary to ensure that the potential risks of engineered nanomaterials are taken into consideration.
  • Not many comments were submitted in writing but the peer review committee had plenty to say about the Environmental Protection Agency’s Nanomaterial Research Strategy (NRS).

    The recent External Peer Review Meeting on the Draft Nanomaterial Research Strategy (NRS) in Alexandria, Virginia, was chaired by the Project on Emerging Nanotechnologies’ Chief Scientist, Dr. Andrew Maynard.

    Other peer reviewers included Richard Denison of Environmental Defense, Rebecca Klaper of the Great Lakes WATER Institute, Igor Linkov of the U.S. Army Engineer Research and Development Center, Carnegie Mellon’s Gregory Lowry, and DuPont’s David Warheit.

    The strategy, developed by the EPA’s Office of Research and Development (ORD), identified four key research themes: Sources, Fate, Transport, and Exposure; Human Health and Ecological Research to Inform Risk Assessment and Test Methods; Risk Assessment Methods and Case Studies; and Preventing and Mitigating Risks.

    The document, released on January, 2008, is a first draft that drew very little public comment and the meeting drew a very small audience with only about 15 people attending. This is curious given the nature and extent of comments provided by the assembled experts.

    Several reviewers felt that the EPA put far too much emphasis on promoting itself rather than focusing on the research strategy. Rebecca Klaper highlighted this by suggesting “the strategy seems to be developed around existing research rather than developing the strategy and establishing the appropriate research to meet the strategy.”

    Richard Denison pointed out two key shortcomings in the strategy. He felt there was not enough information on the criteria or rationale for establishment of research priorities. This sentiment was echoed by several panel members as well. Another problem with the strategy according to Dennis is there is “too much emphasis on applications and not enough on implications of nanoscale materials.”

    EPA communications efforts were also targeted for criticism. While the agency is collaborating internally and with other government agencies, very little information on research is being made public. Reviewers acknowledged the efforts of the agency through its STAR grants but they felt more information on the selection of research projects should be made publicly available. They also felt the agency should release more research results themselves rather than wait for peer-reviewed articles by researchers.

    EPA plans to issue a final research strategy for nanomaterials later in 2008.
  • Environmental Protection Agency (EPA) officials are working hard to get the word out on the Nanoscale Materials Stewardship Program (NMSP) and several companies have been added to the growing list of program participants.

    Over the last few weeks, four more companies have committed to the program. Bayer Material Science, Evonik, General Electric, and Sasol North America made commitments to submit information under the Basic Program.

    Previously, DuPont and Office ZPI made submissions while BASF Corporation, Dow Chemical, Nanocyl North America, Nanophase Technologies Corporation, PPG Industries, and Strem Chemicals made commitments to submit information under the Basic Program.

    Early this month, Jim Gulliford, Assistant Administrator for the Office of Prevention, Pesticides and Toxic Substances, made a presentation at the U.S. Chamber of Commerce Forum Discussion on EPA’s Nanoscale Materials Stewardship Program. The event was co-sponsored by the SOCMA Nanotechnology SME Coalition, American Chemistry Council, and the NanoBusiness Alliance.

    Jim Willis, Director of the EPA’s Chemical Control Division, was a featured guest this week on the Bourne Report, a talk radio program that discusses the latest developments in nanotechnology.

    EPA has indicated it will publish an interim report on the program in early 2009, approximately a year from its launching on January 28, 2008. After approximately two years the agency will prepare a detailed report and program evaluation. At that time, the EPA will evaluate the program, make any needed adjustments to its information-gathering efforts, and determine if any regulatory action under its TSCA authority is appropriate.
  • The National Institute for Occupational Safety and Health (NIOSH) has done more for less than any government agency thus far and now it intends to do even more.

    In a recent posting on its web site, NIOSH summarized its findings of the Nanotechnology Field Research Team. The Team was established in 2006 “to expand its knowledge and understanding of the potential health and safety risks that workers may encounter during the research, production, and use of engineered nanomaterials.”

    In the NIOSH Nanotechnology Field Research Effort the agency’s field work is described and information is provided on how more companies can participate.

    The Nanotechnology Field Research Team Update shares insight on previous site visits and reveals some lessons learned. The site visits provided information that has led to several conclusions: Basic particle counting and sizing instruments can be used to identify emissions from nanomaterial processes; Careful interpretation of the particle data is needed to differentiate between incidental (background) and process-related nanoparticles; and Engineering controls do minimize workplace exposure to engineered nanoparticles.

    A new study to investigate exposures to fine and ultrafine metal oxides is described in the NIOSH Nanotechnology Metal Oxide Particle Exposure Assessment Study. The specific objectives of the study are to: 1) Characterize airborne metal oxides exposure metrics by job or process; 2) Obtain quantitative estimates of exposure to fine and ultrafine metal oxides by particle size; and 3) Evaluate a strategy for measuring workplace exposure to fine and ultrafine metal oxides.
  • It may not be prime time yet but a television show on nanotechnology shows the science may be coming of age.

    Nanotechnology: The Power of Small is a new television series that will explore the implications of nanotechnology. Funded by the National Science Foundation (NSF) and Oregon Public Broadcasting, the three-part series will be hosted by National Public Radio Correspondent John Hockenberry.

    Policymakers, scientists, journalists and community leaders will be questioned by Hockenberry about nanotechnology’s impact on people’s privacy and security, health, and the environment.

    The series, scheduled for airing in April 2008, will be kicked off at a reception hosted by the Project on Emerging Nanotechnologies and NSF at the Woodrow Wilson International Center for Scholars on April 2nd.
  • The United Kingdom’s Voluntary Reporting Scheme (VRS) has met with a fairly low response rate so an internal Defra review was undertaken resulting in updated guidance on the program.

    According to the most recent report from Defra, only 9 submissions have been received. Seven of the submissions have come from industry and two of the submissions have come from academia. No submissions were received in the most recent reporting period.

    The most recent quarterly report by Defra indicated that the Advisory Committee on Hazardous Substances conducted a review of the VRS resulting in the update to “clarify the purpose and aims of the scheme and provide supplemental guidance for anyone submitting data under the scheme.”

    Recommendations from the ACHS focused on two specific areas. For additional guidance, ACHS recommended that “DEFRA should develop an additional document setting out: the context of nanomaterial hazard and risk in the environment, a summary of potential hazard and risk and a specific list of relevant physical, chemical and (eco)toxicological and (eco)toxico-kinetic data required.”

    To improve the current VRS, ACHS recommended additional emphasis on the need for data on nanomaterials actually used by the industrial supplier or manufacturer, confirmation that generic data and data on material in the bulk form is not relevant to the scheme, and additional emphasis that physico-chemical and toxicology data requirements must be provided by someone familiar with the nanomaterials themselves.

    The supplemental guidance, Nanomaterials: Hazards and risks to health and the environment, confirms acceptance of the ACHS recommendations by indicating the guide was prepared to “complement existing guidance for the VRS and help reporters (nanomaterial producers and users) understand the important role of information on the properties and characteristics of engineered nanoscale materials when considering the potential hazards, exposures and risks.”

    In an important revelation to possible volunteers, Defra reported that it is “unable to provide categorical assurance” that toxicokinetic data submitted to the VRS would be held as confidential. The agency indicated that public interest needs may outweigh the need for confidentiality.
  • If you are looking for a way to evaluate the possible risks of nanomaterials and want to learn how to manage those risks, the nano risk framework is the best guidance available and now the public will have an opportunity to discuss the framework with the lead authors.

    Developed in a collaborative effort by Environmental Defense and DuPont, two workshops on the work are planned to share this information with interested stakeholders. The first workshop will be held in conjunction with the Sustainable Packaging Coalition on April 2nd and the second workshop is scheduled for April 8th as part of the Toxic Use Reduction Institute’s Spring Continuing Education Conference.

    Environmental Defense and DuPont released the comprehensive framework to assist with the responsible development and use of nanotechnology and to help inform the global dialogue on its potential risks. Intended for use by small and large companies, regulatory agencies, universities, and others, the Nano Risk Framework was finalized after receiving comments from over 40 organizations, government officials, academics, and individuals.

    The Framework offers a six-step process for organizations to identify, assess, and manage potential risks. The six steps within the Framework include: describing the material and the intended application; profiling the material's lifecycle in this application; evaluating the associated risks; assessing risk management options; deciding and documenting actions; and regularly reviewing new information and adapting actions accordingly.

    To illustrate the effectiveness, flexibility and practicality of the framework, DuPont conducted three demonstration projects on three different classes of nanoscale materials: a new titanium dioxide-based product, carbon nanotubes and zero-valent iron.
  • The latest round of Small Business Innovative Research (SBIR) contracts includes several projects involving nanotechnology and even funds some toxicity testing.

    At least four of the 25 contracts announced by the Environmental Protection Agency (EPA) have an element of nanotechnology. Two of the four projects are being undertaken to develop improved methods for detecting, measuring and monitoring organic pollutants, toxins and microorganisms in water.

    A third project will attempt to develop a new coal gasification technique that will generate clean syngas to power steam and gas turbines. The new technique will use nanopowders and composites to create a highly efficient and purer coal gas.

    One project could have a direct impact on establishing the toxicity of nanomaterials on human health. EcoArray Inc. has been given a contract “to employ microarrays to identify genes that fluctuate in fathead minnows after acute exposure to nanotubes.” The purpose of the study is to determine if any of the pathways are affected in the fathead minnow and if they are, which ones.

    The EPA annually awards Phase I contracts of up to $70,000 to determine if the research idea is feasible and to determine if there is justification for continued research in a Phase II effort. If research proves successful and the firm is deemed capable of high-quality research, up to $225,000 may be awarded for further study.
  • To blunt criticism the EPA has received for taking a voluntary approach to collect information on nanomaterials, the agency is working very hard to encourage participation in the program.

    The Environmental Protection Agency (EPA) has been reaching out to industry in an unprecedented effort to request producers and users of nanomaterials to voluntarily provide information to avoid the need for regulatory action.

    At the recent Global Chemical Regulations Conference, Jim Gulliford, Assistant Administrator for the Office of Prevention, Pesticides and Toxic Substances made a presentation on the Nanoscale Materials Stewardship Program. He reiterated recent EPA guidance on nanoscale materials by highlighting fullerenes and carbon nanotubes as chemicals not on the Toxic Substances Control Act (TSCA) Inventory.

    Gulliford also identified several companies that have already volunteered to provide information on nanoscale materials. DuPont was the first to volunteer but they were quickly followed by BASF, Dow, Strem Chemicals, Nanocyn North America, Nanophase Technologies, PPG, and Office ZPI.

    Over the last month, the EPA has made contact with several industry groups including the Synthetic Organic Chemical Manufacturers Association (SOCMA) Nanotechnology SME Coalition, the American Chemistry Council (ACC) Nanotechnology Panel, and the NanoBusiness Alliance to encourage participation by member companies. These contacts were preceded by phone calls to the CEOs of SOCMA and the ACC to garner executive management support for the program.

    In addition to Jim Gulliford, Charlie Auer, Director of the Office of Pollution Prevention and Toxics and Jim Wills, Director of the Chemical Control Division, have made a series of presentations at a variety of conferences and workshops with the express purpose of encouraging industry participation in the NMSP.
  • It’s always important to know what you don’t know. In the case of the safety of cosmetics containing nanoscale materials, there still is much to learn.

    The European Commission’s (EC) Scientific Committee on Consumer Products (SCCP) recently released their opinion on the safety of nanomaterials in cosmetics. In accepting the final report from the SCCP, the EC acknowledges that there are currently several knowledge gaps that must be filled for a complete risk assessment of nanomaterials in cosmetics. It goes on to suggest that there should be a review of the safety of nanomaterials used currently in sunscreens, such as zinc oxide and titanium dioxide.

    In its Opinion on Safety of Nanomaterials in Cosmetic Products, the SCCP classifies all nanoparticles in one of two categories: “i) soluble and/or biodegradable nanoparticles which disintegrate upon application to skin into their molecular components (e.g., liposomes, microemulsions, nanoemulsions); and ii) insoluble and/or biopersistent particles (e.g., TiO2, fullerenes, quantum dots).”

    The reports states for the first group of nanoparticles, “conventional risk assessment methodologies based on mass metrics may be adequate, whereas for the insoluble particles other metrics, such as the number of particles, and their surface area as well as their distribution are also required.”

    Much of the report reviews the knowledge gaps with a special emphasis on insoluble nanoparticles: hazard identification; exposure assessment; uptake; the role of physico-chemical parameters of nanoparticles determining absorption and transport across membranes in the gut and lungs; the role of physico-chemical parameters of nanoparticles in systemic circulation determining biokinetics and accumulation in secondary target organs; possible health effects; and translocation of nanoparticles via the placenta to the fetus.

    According to previous reports by Friends of the Earth and the Project on Emerging Nanotechnologies, there are hundreds of cosmetics on the market with claims of nano-enabled ingredients. This was also the subject of intense discussion and debate at a public FDA meeting in October 2006.
  • An increasing number of food products have been enhanced with nanotechnology and concerns for food safety are increasing as well.

    Friends of the Earth recently released a report that found more than a hundred foods, food contact materials and agricultural products with nanomaterials are now on sale internationally. These include diet replacement milkshakes, cooking oil, tea and fortified fruit juice; food additives sold for use in processed meats, soft drinks, bakery and dairy products; long-life and antibacterial food packaging; and antibacterial kitchenware.

    The report, Out of the Laboratory and On To Our Plates: Nanotechnology in Food & Agriculture, inventories nanotechnologies in food. It also calls for four policy recommendations to be implemented worldwide and specifically in the U.S., EU and Australia.

    Among the recommendations is a call for a “moratorium on the further commercial release of food products, food packaging, food contact materials and agrochemicals that contain manufactured nanomaterials until nanotechnology-specific safety laws are established and the public is involved in decision making.”

    “Friends of the Earth calls on the FDA to stop the sale of all nano food, packaging, and agricultural chemicals until strong scientific regulations are enacted to ensure consumer safety and until ingredients are labeled,” said Ian Illuminato, Friends of the Earth Health and Environment Campaigner. “Consumers have a right to know if they are taste-testing a dangerous new technology.”

    The organization also calls for more pragmatic measures in the ongoing discussion about nanotechnology risk assessments. The recommendations are: nanomaterials should be regulated as new substances; the size-based definition of nanotechnology should be extended to cover up to 300nm in particle size; products with nanotechnology-enabled ingredients should be labeled as such; the public should be involved in decision-making; and nanotechnology should be considered in the context of sustainable farming and food.

    In 2006, the group also released Nanomaterials, Sunscreens and Cosmetics: Small Ingredients, Big Risks highlighted the risks of nanotechnology in cosmetics.
  • Calls for the regulation of nanotechnology are being heard around the globe. The United States, Canada, Europe and now, Japan, are giving those calls serious consideration.

    The Japanese Ministry of Health, Labor, and Welfare held its first meeting on the safety of nanomaterials in Tokyo. The effort is the collaboration between two study groups on occupational exposure to nanomaterials and nanomaterial safety.

    One study group will hold meetings on how to limit worker exposure nanomaterials in the workplace and a second study group will consider the larger questions of the safety of nanomaterials.

    These study groups are planning to conduct discussions together for the first three meetings. Shoji Fukushima, director at the Japan Industrial Safety & Health Association and Japan Bioassay Research Center, has become the chairman of both study groups. Representation in the groups includes members of government regulatory and research agencies, academia and industry.

    Formation of the groups is in response to a Labor Standards Bureau regulation issued in February that required efforts to seal manufacturing facilities, manage processes so workers are not exposed to nanomaterials and require that workers wear dust masks and other items to protect their breathing.

    At the second meeting scheduled in April, the study groups are planning to discuss the state of nanotechnology development through expert testimony. At a third meeting in May, the study groups will discuss the state of nanotoxicology. More than 20 kinds of nanomaterials including fullerenes, carbon nanotubes, oxidized titanium, oxidized zinc and quantum dots are targeted by the study groups.

    In contrast to the U.S., the Japanese government is beginning its examination of nanotechnology regulation through its occupational health regulatory authorities. It is expected that the study groups’ findings will explore the viability of such regulations for Japan.
  • Companies making antimicrobial claims with nano-enhanced products will need to think twice about their efficacy and the need to register their product as a pesticide.

    ATEN Technology of Irvine, California has reached a settlement with the EPA to pay $208,000 for selling unregistered pesticides and making unproven claims about their effectiveness. Under the IOGEAR brand, the products at issue were a wireless laser mouse with a nanotechnology shield coating, laser travel mouse with nanotechnology coating and wireless keyboard and mouse combinations.

    After being contacted by the EPA, IOGEAR stopped making claims that their computer peripherals protect against germs.

    Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), products with claims of pesticidal or antibacterial effects must be registered with the EPA. The EPA tests such claims for effectiveness and general safety for the public.

    For some time there have been many such products on the market and the Project on Emerging Nanotechnologies’ Consumer Product Inventory catalogues many of these products. The database cites at least 100 products with similar antibacterial claims.

    As the regulatory issue with nanoscale silver ions and washing machines played out last year, many companies stopped marketing claims of antibacterial effects with nanoscale silver to avoid the registration process. According to recent reports, at least one other product manufacturer found the registration troublesome enough to discontinue production.

    With action against IOGEAR, the EPA has provided a clear indication that nanotechnology-enhanced products making antibacterial claims must meet the same requirements for pesticides under FIFRA.

    In some sense, the discussion about registering nanotechnology-enabled antibacterial products has not ended. Nanotechnology companies are, at least in this instance, seeing regulation as a barrier to market entry. These companies would do well to educate themselves on existing regulations governing antimicrobial products.

    This represents a significant first step for regulating nanotechnology in the U.S., as it is one of the first times that existing regulatory statutes controlled the distribution of a nanotechnology-enabled product. This could provide a basis to argue that new regulatory statutes or frameworks for nanotechnology are not needed if existing regulations are enforced diligently.
  • The National Institute for Occupational Safety (NIOSH) has released an updated version of its strategic plan for nanotechnology research.

    Since the first version was released in 2005, NIOSH has excelled in research and industry outreach as well as collaborative efforts with nanotechnology companies and research laboratories to gain a better understanding of nanotechnology in occupational settings. This new draft document provides an accounting of current NIOSH projects and needed future projects through 2012.

    According to NIOSH, the Research Strategic Plan for NIOSH Nanotechnology Research: Filling the Knowledge Gaps, “represents a cohesive, multidimensional, and timely research agenda for addressing knowledge gaps concerning possible worker exposures to nanomaterials, the health risks from such exposure, and development of control technology and prevention measures.”

    NIOSH has established four strategic research goals: 1) Determine if nanoparticles and nanomaterials pose risks for work-related injuries and illnesses; 2) Conduct research to prevent work-related injuries and illnesses by applying nanotechnology products; 3) Promote healthy workplaces through interventions, recommendations, and capacity building; and 4) Enhance global workplace safety and health through national and international collaborations on nanotechnology research and guidance.

    Ten research areas to meet the four strategic goals were identified in the draft document: Exposure assessment; Toxicity and internal dose; Epidemiology and surveillance; Risk assessment; Measurement methods; Engineering controls and personal protective equipment; Fire and explosion safety; Recommendations and guidance; Communication and information; and Applications.

    The plan goes into detail on specific research projects, timing for the projects, their impact on meeting the strategic goals, and intermediate goals listed with clear metrics for success. The revised strategic plan will be open for public comment until June 1, 2008.
  • If you haven’t defined the problem, how can you expect to solve it?

    In an opinion article in the August 2007 issue of Environmental Science and Technology, Richard Owen, head of the Environment and Human Health Programme at the U.K. Environment Agency and Richard Handy of the University of Plymouth question the rush to embark on environmental risk assessments and related research of nanotechnology without clear priorities or problem formulation. The authors also question the validity of connecting the risks associated with nanoparticle with its bulk counterpart

    The recent release of research strategy documents from the National Nanotechnology Initiative and the US Environmental Protection Agency are charting the course for environmental, health and safety research into nanotechnology for the foreseeable future.

    However, the authors suggest that the next two years will likely establish the environmental risks of nanotechnology and the related risk management measures. If the strategy documents incorrectly guide research about the environmental risks of nanotechnology, policymakers and other stakeholders will probably not make the right decisions about governing nanotechnology and its future.

    For all of nanotechnology’s stakeholders, it is absolutely paramount that we have asked the right questions about nanotechnology’s potential risks, and that we prioritize and fund the right research. Any mistakes that are made in creating the strategy will likely lead to bigger mistakes in managing nanotechnology in the future.
  • Looking for a basic guide on safety in the nanotechnology workplace? Well, you don’t need to look very far.

    The National Institute for Occupational Health and Safety (NIOSH) continues to take the lead on workplace safety for the generation and use of nanomaterials. A recently released brochure, An Introduction for Employers, Managers, and Safety and Health Professionals, provides an excellent guideline on what must be considered when evaluating nanotechnology safety.

    In the brochure, four questions are posed: Are nanoparticles hazardous to workers?; How can workers be exposed?; Can nanoparticles be measured?; and Can worker exposures be controlled? Rather than attempt to provide answers, each question is paired with information that should be considered when evaluating potential health threats to workers.

    For a more in-depth discussion of workplace safety and nanomaterials, Approaches to Safe Nanotechnology: An Information Exchange with NIOSH is recommended reading.
  • Australian researchers have released results of two studies on zinc oxide to assess the potential risks associated with these nanomaterials. There were limits to the tests but the results are promising.

    Results of the research on zinc oxide nanoparticles, used often in sunscreen formulations, were presented at the International Conference on Nanoscience and Nanotechnology in Melbourne in late February.

    Sunscreens often use zinc oxide and titanium dioxide nanoparticles because they do not leave a chalky white residue after applying them to human skin. With the major concerns about nanotechnology and its possible risks, researchers are looking into their potentially toxic effects on human health.

    One study looked into skin absorption of zinc oxide nanoparticles in sunscreens. Two human subjects applied a sunscreen that contained special zinc oxide nanoparticles made from a non-radioactive isotope of zinc that does not occur naturally. Taking blood and urine samples for days afterward, researchers found that the nanoparticles were not readily absorbed into the skin.

    The second study looked into the immunotoxicity of zinc oxide and other nanoparticles. Although zinc oxide nanoparticles are more toxic than other nanoparticles in killing human immune cells in vitro, it only occurred in extremely high concentrations. According to researchers, the nanoparticles would likely be cleared from the body before such concentrations could accumulate.

    Sunscreens with nanoparticles are among the first nanotechnology-based consumer products, and there are few publicly-available studies on their toxic effects for human health. These studies should probably reassure the public and nanotechnology community, but the implications of these studies are clearly limited. Any finding of a significant toxic effect of sunscreens for human health or the environment could have a crippling effect on the industry.
  • Another code of conduct has been created and released by the European Commission as seven principles designed to govern nanotechnology research.

    With the release of the Code of Conduct, the European Union is the first national or international entity to release codes of conduct on nanotechnology research. The Code of Conduct was the result of consultations and a first draft released last July. Other organizations, such as the Foresight Institute and the Nanotechnology Industries Association, have or are consulting on codes of conduct for nanotechnology and its development.

    Some companies have internal codes of conduct about the risk management of nanomaterials, like the Environmental Defense and DuPont-sponsored Nano Risk Framework.

    The White House Office of Science and Technology Policy (OSTP) published principles for nanotechnology oversight, but these are not quite a code of conduct in scope and breadth.

    The Principles of the Code of Conduct include: meaning, sustainability, precaution, inclusiveness, excellence, innovation, and accountability. The Code of Conduct is meant to encourage Member States to implement these with the governance of research, a precautionary approach to development and further dissemination of the Code of Conduct.

    The Code of Conduct is a noble attempt to promote the new mantra of social responsibility for nanotechnology. It is not clear that these principles are legally-binding in any way or that Member States are obligated to use these principles in their own research programs. The emphasis on sustainability and precaution are not shared by the OSTP principles for nanotechnology oversight.
  • Attempting to answer criticisms from industry, non-governmental organizations and House Science Committee members for a lack of strategic vision, the National Nanotechnology Initiative (NNI) released a revised environmental, health and safety (EHS) research strategy.

    The revised document, Strategy of Nanotechnology-Related Environmental, Health, and Safety Research, is a follow-up to two previous documents on the same subject released in September 2006 and August 2007.

    The document lays out an approach around five major themes: instrumentation and measurement, human health hazards, environmental hazards, exposure, and risk management methodology. The National Institute of Standards and Technology, the National Institute’s of Health, the Environmental Protection Agency, the National Institute of Occupational Safety and Health, and the Food and Drug Administration will be the main agencies to carry out the strategy.

    The document goes through an extensive inventory of previous research projects in FY 2006. The federal government provided $68 million in funding for 246 projects at seven agencies. From FY 2005 through the current budget request for FY 2009 the NNI will invest an estimated $254 million in EHS research on nanomaterials.

    Most of the research was focused on instrumentation, metrology and analytical methods (78 projects, $26.6 million) and nanomaterials and human health (100 projects, $24.1 million). Nanomaterials and the environment (49 projects, $12.7 million), human and environmental exposure assessment (5 projects, $1.1 million) and risk management methods (14 projects, $3.3 million) were the other key research areas.

    During the last four years, the NNI estimates that $254M has been invested in risk research. This inventory of research projects on the EHS implications of nanotechnology is used to perform a gap analysis of the proposed strategy. The gap analysis then projects the short, medium, and long-term focus of the research strategy’s priorities.

    Meanwhile, criticism of the document has already emerged. Environmental Defense’s Richard Denison has questioned the validity of the 2006 inventory of research. The NNI also claims that there should not be a strong connection between this research and regulatory decision-making.

    “Gaps identified in the research that supports regulatory decision making should not be addressed at the cost of broad-based fundamental research – to do so would ultimately undercut the U.S. nanotechnology initiative as a whole.” The $76M requested for 2009’s NNI budget still falls short of $100M – the amount previously requested by Environmental Defense among others.

    At the Project on Emerging Nanotechnologies, Dave Rejeski thinks that, “the structure and plan are still broken.” He also stated that the document “fails to employ a ‘top-down’ strategic approach aimed at directing funds and research at the places where there’s likely to be the most risk.”
  • NanoSafe2’s first dissemination report answers pressing questions about the ability of fibrous filters and personal protective equipment to protect against nanoparticles.

    The conclusions of the report are based on research studies performed by NanoSafe2. Based on the results, the report, Safe Production and Use of Nanomaterials, makes several conclusions:

    First, fibrous filtration media are efficient for filtering particles below 100 nanometers, but filter efficiency falls between 100 and 1,000 nanometers. This is consistent with previous research in the area and refutes a commonly-held misconception about filters.

    Second, HEPA filters, respirator cartridges and masks made with fibrous filters may be adequate for nanoparticles. Typically, the seal between the mask and face is the most common way for nanoparticles to get past the filter.

    Third, air-tight, non-woven fabrics are found to be much more efficient than woven fabrics, like cotton, at filtering nanoparticles. Workers should avoid wearing cotton and other woven fabrics, as they might allow for nanoparticles to penetrate the skin.

    The report also recommends at least two layers of gloves. Diffusion tests performed with 30 nanometer and 80 nanometer graphite nanoparticles showed that nanoparticles go through commercially available gloves.

    Beyond higher-level occupational health strategies for nanotechnology workplaces, this is the first report to answer common questions about the usage of personal protective equipment to limit worker exposure to engineered nanoparticles.
  • When the public considers competing arguments about nanotechnology’s potential risks and benefits, people will tend to agree with the expert whose values are closest to their own – no matter the position.

    A new study on the subject, conducted by the Yale Law School and Project on Emerging Nanotechnologies, was based on experiments involving 1,600 American adults and carried out by the Cultural Cognition Project at Yale Law School.

    As part of the study, Biased Assimilation, Polarization, and Cultural Credibility: An Experimental Study of Nanotechnology Risk Perceptions, participants read opposing arguments that were randomly attributed to fictional policy experts from major universities to form an opinion on nanotechnology – a cutting-edge technology about which little is known by the public.

    “Because most people lack the time and expertise necessary to make sense of scientific information on complex and novel risks, they naturally rely on experts whom they trust to determine what information to believe. Individuals are inclined to trust those who share their cultural outlooks,” according to the study’s lead author Yale Law School professor Dan Kahan.

    This effect of trusting the experts that shares their values tends to polarize the public. This will make the effort to educate the public on nanotechnology’s risk and benefits even more difficult. The public will tend to bias towards those that they can see similarities in values. Informing the public about nanotechnology will not be a naďve proposition of simply distributing the facts and letting the public make a decision.

    Ideally, the public should receive the same information about nanotechnology from a variety of sources where their bias about finding similar values tends to disappear in the face of so many sources.

    In the third and final study in this series of experiments, expected to be completed in spring 2008, the Cultural Cognition Project will explore the persuasiveness of different messages coupled with a variety of trusted messengers on various audience groups.
  • Regulating nanotechnology at any level of government has proven to be very difficult. To examine international oversight of nanotechnology, new research will be conducted comparing regulatory policies in the United States and the European Union.

    Researchers at the London School of Economics and Political Science (LSE), Chatham House, Environmental Law Institute (ELI) and the Project on Emerging Nanotechnologies (PEN) have been awarded a $587,000 European Commission grant to conduct an international research project on regulating nanotechnologies in the European Union and United States.

    In the context of previous ineffective efforts to coordinate regulation on chemicals, beef hormones, and genetically modified organisms, this grant attempts to improve transatlantic cooperation on such issues for nanotechnology.

    The project will be coordinated by international relations expert Dr. Robert Falkner, a deputy director of LSE's Centre for Environmental Policy and Governance.

    Project goals include: to produce high quality analysis of the comparative dimensions of nanotechnologies regulation in the EU and U.S.; to publish and widely disseminate policy-relevant research results that will assist policy processes and debates on both sides of the Atlantic; and to create greater awareness among decision-makers and opinion formers for congruent approaches and transatlantic convergence in nanotech regulation.

    Previous work done by the Project on Emerging Nanotechnologies and the Foresight and Governance Project will provide a basis for the new research. The Environmental Law Institute has been involved in analyzing the regulatory landscape for nanotechnology, since they hosted a 2005 dialogue on nanotechnology and environmental law.

    Work products for the project will involve a research report and analytical papers based on comparative research, a major international conference, and outreach across the EU and US in 2009. The project findings will feed into a major EU conference in 2009 and the EU-U.S. Summit in 2010.
  • The European Commission adopted the opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on definitions for nanotechnology. The opinion considered risk assessment as a major concern in defining nanotechnology terms and definitions.

    SCENIHR was charged with defining a conceptual framework to assess proposed definitions for nanotechnology and related terms; reviewing the strengths and weaknesses of the proposed definitions based on the aforementioned conceptual framework; and a minimum set of criteria for developing definitions.

    In the recently released opinion, The Scientific Aspects of the existing and proposed definitions Relating to Products of Nanoscience and nanotechnologies, SCENIHR concluded that definitions should be evaluated based on their compatibility with other terms used in science, their uniqueness and lack of suitable alternatives, their relevance to risk assessment or related purposes, and their ease of translation. Criteria used in the definition of terms include scientific validity, clarity, the need for practicality and their ability to stand alone.

    It is difficult to evaluate presently proposed definitions, since current risk assessment efforts could be excluded or included based on the definitions. For example, a definition of nanotechnology that excludes applications and technology beyond 100 nanometers may not make sense.

    Applications with components of 200 to 300 nanometers may have the same environmental, health and safety risk implications as those below 100 nanometers. Their exclusion would also exclude them in future discussions about the potential risks of nanotechnologies. The report acknowledged the difficulty of evaluating definitions without more thorough risk information on nanotechnology.
  • A report prepared for the members and committees of Congress on the regulation of nanotechnology has been released about the possible need for “federal intervention.”

    The Congressional Research Service (CRS) recently released Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges to address the call for Congress to enact legislation creating new nanotechnology regulations. The goal of the report was “to consider certain challenges faced by scientists, entrepreneurs, and government officials in the 25 agencies involved in the National Nanotechnology Program, as they strive to define the characteristics of nanomaterials, the environmental, health and safety (EHS) risks they might pose, and how any potential risks should be addressed.”

    Over the life of the National Nanotechnology Initiative (NNI), the CRS - the research support services for Congress - has prepared several reports for Congress on the need for funding research and development. This is the first CRS report to review regulatory options for nanotechnology.

    The report lays out the major challenges for regulating nanotechnology including the broad diversity of nanomaterials and their applications; the lack of basic information to characterize nanomaterials; the lack of standards and nomenclature to date for nanotechnology; the proprietary nature of information on nanomaterials held by private companies; the difficulty of communicating information across academic disciplines; the lack of federal resources; and, possibly, no clear statutory authority to anticipate or respond to any identified risks.

    The report also identifies options for Congress to address nanotechnology regulation. They include increased funding for EHS research of nanomaterials and/or reallocation of funding in the present NNI structure for EHS research; mandate the reporting of information by nanotechnology companies; and clarifying regulatory agencies’ authority to regulate nanotechnology.

    Nanotechnology’s challenges might be overcome by increased research funding and without regulation according to conclusions reached by the CRS. In any case, the potential risk issues of nanotechnology are pressing, as the pace of commercialization intensifies. The report is noteworthy because it shows that Congress might be seriously considering regulation nanotechnology.
  • In response to a very public outcry for a research strategy for the environmental, health and safety impact of nanomaterials, the U.S. Environmental Protection Agency (EPA) has released a framework for the strategy.

    The EPA recently released the Office of Research and Development’s Draft Nanomaterial Research Strategy which is designed to guide the agency’s strategy.

    For the EPA, the main challenge for environmental protection is to minimize nanotechnology’s potential unintended harmful consequences for the environment, while environmental applications of nanotechnology are still pursued for their positive potential.

    The draft builds on, and is consistent with, scientific needs identified in the National Nanotechnology Initiative’s previous reports and the EPA’s Nanotechnology White Paper. The Office of Research and Development gives special attention to EPA’s mission to protect the environment and its specific needs for being able to regulate nanotechnology.

    Four major thematic areas for further research are delineated in the document: environmental fate and transport; human health implications; risk assessment methodology; and risk mitigation strategies.

    Initially, the EPA is focusing on nanoscale titanium dioxide, zero valent iron, nanosilver, carbon nanotubes, and cerium oxide. The hope is that research on these nanomaterials can be extrapolated for classes of nanomaterials in the future.

    Anticipated outcomes from this research program are expected to be focused research products to address risk assessment and management needs for nanomaterials in support of the various environmental statutes for which the EPA is responsible.

    The EPA will convene an expert panel peer review meeting to review the draft on April 11th with comments due by March 14th. The public may register for the meeting online.
  • Nanotechnology is having an impact on food and questions regarding safety are being raised. This has led to a request by the European Commission for a scientific opinion on the matter.

    On January 23rd, the European Food Safety Authority (EFSA) issued an open call requesting scientific data on nanotechnology applications on food and feed. The open call ends on March 28th in preparation for a draft opinion to be issued by an expert working group working on the issue.

    This confirms an earlier report covered in the NanoReg Report in November that EFSA said it was unprepared to issue an expert opinion by March 2008 as originally planned. This letter indicates the expert opinion should be issued by July.

    In a process that seems similar to the first discussions about the EPA’s voluntary nanomaterials program, EFSA is looking for any scientific opinion relating to the public health and environmental risks of nanotechnologies in food. EFSA holds a high standard for any submissions that they be of peer-reviewed publication quality.

    The data requested ranges from basic data on the safety of nanomaterials in food and feed to any methodology used to analyze the nanomaterials in food or feed.

    From an industry perspective, it is unclear if anyone will cooperate with such an open-ended request even with assurances of confidentiality. The industry is integrating nanotechnology with food, but most applications are only now reaching the market.

    If this effort is similar to the UK’s Defra Voluntary Reporting Scheme, EFSA may only find submissions from academic groups. In a one-page letter, the purpose of the solicitation is unclear and the inclusion of feed, assuming animal feed, is also vexing.
  • Nanotechnology has been cited as a global core risk but where does it stand compared to other risks?

    The World Economic Forum released a report, Global Risks 2008, A Global Risk Network Report, which cited nanotechnology as global core risk. The report focused on four general areas of emerging issues in risk: systemic financial risk, food security, supply chain vulnerability and energy.

    The report was published by the Global Risk Network in partnership with Citigroup, Marsh & McLennan Companies, Swiss Re, Wharton School Risk Center and Zurich Financial Services.

    When compared to the other 26 global core risks listed, nanotechnology compares favorably. In a chart graphing economic loss with likelihood, nanotechnology had a one to five percent likelihood of causing about $50B worth of economic loss.

    In another measure of risk, nanotechnology was found to have around a 4-5% likelihood of causing 1,600 to 5,000 deaths worldwide. These risk estimates are done an annual basis by the consortium of authors on the report.

    Authors of the report cite risks attributed to studies that show potential human health risk due to exposure of nanomaterials. The impacts of these risks could affect public health and the associated investments in nanotechnology commercialization and research.

    The report also counsels that these risks should be weighed against opportunities presented by promising nanotechnology research. Obviously, the report is playing out the future of nanotechnology, as the potential for widespread exposure to nanomaterials is fairly small.

    Though this is not the first year that nanotechnology has been cited as global risk, it does show that nanotechnology has continued to be on the radar of risk assessors from various perspectives. When projected against other global risks, such as oil prices, nanotechnology is comparatively of lower concern.
  • The UK Department of Environment, Food and Rural Affairs (Defra) has published the fifth quarterly report for the Voluntary Reporting Scheme (VRS) for engineered nanoscale materials. The VRS has failed to add any new submissions during the last quarter of 2007.

    The report states, “No new submissions have been received since the publication of the last report in September 2007. A total of 9 submissions have been received since the scheme’s launch in September 2006, seven from industry and 2 from academia.”

    Given the perceived low involvement in the VRS, UK Defra is currently drafting documents to clarify its aim and to provide guidance on submissions, where needed. These new documents should be released in first half of this month.

    The report reiterated its commitment to maintaining the information’s confidentiality, as it hopes the submissions will contribute to an evidence base for international research, such as the Organisation for Economic Cooperation and Development’s Working Party on Manufactured Nanomaterials.

    In September, the UK Defra will document a holistic assessment of the VRS and its ability to meet its own stated objectives and recommendations for further actions.

    With the launch of the Environmental Protection Agency’s Nanoscale Materials Stewardship Program (NMSP), it is hoped that the NMSP can do better. Clearly, the hopes for U.S. program are for more than 9 submissions. The failure of voluntary initiatives for nanotechnology regulation could draw more pressure for new regulations or reinterpretations of existing regulations to better understand nanotechnology’s risks and directly regulate, if needed.
  • The British Standards Institute (BSI) recently published a guide to safe handling of nanomaterials. In a bold move beyond other similar documents published by NIOSH, ASTM and the ED-DuPont partnership, the document sets benchmarks for worker exposure limits.

    The document, PD 6699-2:2007 Nanotechnologies - Part 2: Guide to safe handling and disposal of manufactured nanomaterials, provides a level of detail about the risk assessment of nanomaterials in the workplace that has not been previously published. No other government agency or organization has taken the next step in establishing workplace exposure limits.

    The document classifies nanomaterials into four categories: fibrous; carcinogenetic, mutagenic, asthmagenic or a reproductive toxin (CMAR); insoluble; and soluble. For fibrous nanomaterials, carbon nanotubes are a perfect example. CMAR is meant to include nanomaterials that might be documented as carcinogenetic, mutagenic, asthmagenic or a reproductive toxin at the bulk scale. Insoluble applies to nanomaterials not in the first two categories and is also poorly soluble. Finally, soluble would probably include all other nanomaterials not included in the first three categories.

    The workplace exposure limits (WELs) are set at 0.01 fibers per milliliter for fibrous, 0.1 of the existing WEL for CMAR nanomaterials, 0.066 of the existing WEL for insoluble nanomaterials and 0.5 of the existing WEL for the soluble nanomaterials.

    The document also indicates that, “It is inappropriate in the absence of knowledge to assume that a nanoparticle form of a material has the same hazard potential as it has in a larger particulate form.” The document took the stance that the hazard potential is probably greater than its bulk counterparts. The guidance throughout the document is consistent with this finding.

    These WELs should send a shockwave through the environmental, health, and safety community. The British Standards Institute approved this publication after much painstaking work over the past couple years. To date, this is most thorough openly-available publication on the topic and industrial hygienists should take the framework seriously.
  • The long-awaited voluntary program has been released and DuPont has already stepped up the plate with the first submission.

    The Environmental Protection Agency (EPA) released its long-awaited Nanoscale Materials Stewardship Program (NMSP) to the public on January 28th. The first discussions of a voluntary program occurred July 2005 at a public meeting to suggest possible program elements. Over two and a half years later, the EPA formally released a two-tiered program for industry participants – Basic and In-Depth.

    The NMSP’s goal is “to complement and support its new and existing chemical efforts on nanoscale materials” under the Toxic Substances Control Act (TSCA). Under the Basic Program, participants are encouraged to use the data submission form and worksheet provided by the EPA to submit existing knowledge about their own manufacture or use of nanomaterials. Even if participants do not use the EPA’s suggested submission format, the EPA will take the information in any form given.

    In contrast, the In-Depth Program requests that participants not only submit existing data on nanomaterials manufactured by the company, but also collaborate with the EPA on producing new data on the nanomaterials over a longer timeframe. The hope is that submissions under the Basic Program will provide guidance on the new data needed.

    DuPont was quick to become the first to submit documentation to the Basic Program. The nanomaterial, titanium dioxide used in Light Stabilizer 210, was also the first released under the Nano Risk Framework, a risk management framework for nanomaterials created by a partnership between DuPont and Environmental Defense.

    Even with the positive momentum created by DuPont’s submission, at least two organizations have already characterized the NMSP’s release as misguided. For Richard Dennison, Environmental Defense Senior Scientist, the program is too little, too late. “EPA is simply ‘kicking the can down the road’ by shunning approaches that could have delivered needed information faster, and by opting instead to pursue an open-ended approach with no end in sight.”

    David Rejeski, Director of the Project on Emerging Nanotechnologies (PEN), was equally critical of the program. "The information obtained under the stewardship program could help government officials develop a better understanding of the risks and benefits posed by the novel materials, but this voluntary program provides virtually no incentives for industry participation. Swift action is needed now to ensure public and market confidence in the safety of these materials.”

    PEN Senior Advisor J. Clarence Davies added to the chorus of criticism. "The agency's current oversight approach is inadequate to deal with nanotechnology. It is essential that EPA move quickly to recognize the novel biological and ecological characteristics of nanoscale materials.”

    The EPA has established a “target” date of six months for submissions but a more detailed report and program evaluation will be published after two years. At that time, EPA intends to determine the future direction of both the basic reporting and in-depth data development phases, although adjustments or decisions on future steps may be made at an earlier point if sufficient information is gained. EPA action could also include consideration of use of existing regulatory authorities under TSCA.
  • A broad coalition of non-governmental organizations, industry groups and nanotechnology companies applauded a Congressional appropriation for the National Academy of Sciences (NAS) to develop and oversee the implementation of a federal environmental, health, and safety (EHS) research strategy for nanotechnology.

    This coalition has, in the past, called on the federal government to increase funding for risk research and now has won a significant victory in having an independent review and implementation of EHS risk research.

    The intent of this latest appropriation for nanotechnology safety research is for the Environmental Protection Agency (EPA) to contract with the NAS Board on Environmental Studies and Toxicology (BEST) to “develop and monitor implementation of a comprehensive, prioritized research roadmap for all Federal agencies on environmental, health and safety issues for nanotechnology.” Congress also calls on the EPA to establish the contract by March 21, 2008.

    According to coalition members, such discussions have underway since late 2005 for such a plan to implement an EHS research strategy. Publicly, the latest calls for this action were heard at the last Congressional hearing on nanotechnology and EHS implications on October 31, 2007.

    This latest action by Congress should not be confused with NNI current contract with the NAS to review its latest EHS research strategy document presented at the same Congressional hearing. This contract is for a one-time review, while the EPA contract will be a multi-year effort with BEST.

    This is an important development for all stakeholders which should lead to a faster, thorough, accountable approach towards researching the EHS implications of nanotechnology with federal funding.
  • The UK’s Soil Association says nanotechnology is a potential health risk. It will refuse to certify products made with manufactured nanoparticles as organic.

    The Soil Association claims to be the UK’s largest organic certification body. In a press release, the organization says there is insufficient evidence about the impact of nanotechnology on the environment and human health. It says the technique is already used to make some cosmetics and sunscreens, but the products are not required to carry warning labels.

    According to Gundula Azeez, Soil Association policy manager, “The Soil Association is the first organization in the world to ban nanoparticles. There should be no place for nanoparticles in health and beauty products or food. We are deeply concerned at the government’s failure to follow scientific advice and regulate products.”

    Azeez also said “There should be an immediate freeze on the commercial release of nanomaterials until there is a sound body of scientific research into all the health impacts. As we saw with GM, the government is ignoring the initial indications of risk and giving the benefit of the doubt to commercial interest rather than the protection of human health."

    The organization stressed that its ban on the use of such materials was particularly for health and beauty products, but also applied to food and textiles, stating that it was taking action against this hazardous, potentially toxic technology that poses a serious new threat to human health.

    This is a significant event for nanotechnology that a certifying organization has taken such action which cites the 2004 UK Royal Society report as evidence of nanotechnology’s risks. The group also says this same report should have caused regulatory action on the issue.

    It should also come as no surprise that the ETC Group, an Ottawa, Canada-based non-profit research and advocacy group, has endorsed the Soil Association’s opinion. The government and industry response to such a move should be watched closely, as organic foods and nano-enhanced consumer goods have become a hot consumer trend.
  • The European Union has published over 42 different calls for proposals related to nanotechnology under 10 different headings.

    The Seventh Framework Program (FP7) bundles all research-related EU initiatives together under a common roof playing a crucial role in reaching the goals of growth, competitiveness and employment.

    Under the Impact Assessment and Societal Issues heading, the calls for proposal are: validation, adaptation and/or development of risk assessment methodology for engineered nanoparticles; impact of engineered nanoparticles on health and the environment; support to outreach and communication in nanotechnology; and encouraging co-operation and networking between scientific events organizers on public engagement with science.

    Two of the calls for proposal largely deal with environmental, health and safety (EHS) implications of nanotechnology. Specifically, one asks for proposals on the development of new or existing risk assessment methods for nanotechnology in the absence of complete information on nanoparticles.

    Other call’s technical scope allow for broadly scoped investigation of the human health implications and the environmental fate and transport of nanoparticles. With respect to the latter call, it indicates that any proposals should take advantage of previously established ties with U.S. federal agencies on research of these topics.

    The National Science Foundation, Environmental Protection Agency and others have previously published such funding solicitations within the U.S. It continues to form a two-pronged approach to nanotechnology’s EHS implications – public outreach and scientific research. This strategy needs to be continually updated, as the latest public outreach efforts should be informed by the latest scientific findings.

    Information for submission and details of these calls for proposal are on the EU FP7 website.
  • The new administration is reportedly cutting short, by two years, the national nanotechnology program set up by the previous government as part of a cost-saving exercise.

    As the Australian government seeks savings of more than $10 billion, one of the casualties will likely be the four-year, $21.5 million National Nanotechnology Strategy. It is to be cut short by two years, saving almost $12 million.

    The new government pledged to increase investment in science research and development, but now has decided to quit on the National Nanotechnology Strategy. The government claims that the goals for nanotechnology’s development are worthy of government funding, but it does not agree with the planning behind the strategy. This leaves a hole in researching its potential risks and the ability to manage them with regulation.

    The Australian Council of Trade Unions raised concerns about potential human health and environmental risks from nanotechnology when the strategy was first approved in 2006. It had earlier indicated it would back the prohibition of nanoparticle production if risks could not be managed.

    In the original strategy, one of the three future priorities in 2009 was to convene an environmental, health and safety working group to coordinate on regulatory issues. This will now be eliminated from the remaining budget.

    Japan, the EU and the US are all heavily investing in nanotechnology at the government level and the Australian government may be missing an opportunity to capitalize on a new technology boom as well as the ability to anticipate its risks and opportunities.

    With or without an investment, nanotechnology-based consumer goods are sure to hit the shelves of Australian retailers, if they have not already. Public outreach should be a big part of any remaining national budget.
  • A new report released by the Emerging Risks Team of Lloyd’s takes a cautious approach towards nanotechnology. It also features nanotechnology very highly in its list of emerging risks.

    The report was released after a seminar presented in collaboration with the Lighthill Risk Network. In a follow-up to a previous issue’s report on that seminar and the brief presented there, the more comprehensive Nanotechnology: Recent Developments, Risks and Opportunities presents a cloudy future for nanotechnology’s risks.

    It highlights the major economic opportunities and beneficial technologies presented by nanotechnology as increasing insurer exposure to losses in the face of a major nanotechnology risk event. For example, nanotechnology could lead to safer cars, as nanocomposites could absorb a crash’s blow. The market for such products would be enormous. At the same time, insurers realize that the same nanocomposites may pose human health or environmental risks which could potentially lead to huge losses.

    To Lloyd’s, emerging risks are issues that are “perceived to be potentially significant but which may not be fully understood or allowed for in insurance terms and conditions, pricing, reserving or capital setting.” In this context, the report outlines that a major risk event stemming from nanotechnology could result in insurers paying for losses in seven different ways. But no one knows the likelihood or impact of nanotechnology risks.

    The report counsels insurers to look for clarity in the regulation of nanotechnology. Typically, insurers see regulation as enabling liability exclusions to be clearer. With the lack of regulation, such exclusions must be broad enough to fit future regulations.

    This report confirms that even insurers see nanotechnology regulation as essential to covering their own risks. Other stakeholders will have to wait to see how, and if, insurers attempt to influence the process as new nanotechnology regulations are considered.
  • Wisconsin Representative Terese Berceau has written a letter to the Departments of Natural Resources, Health and Family Services and Agriculture, Trade and Consumer Protection calling for the establishment of a policy to require private companies that manufacture nanoparticles to disclose information about the types of particles they're making.

    "The measurement of and accountability for such materials has become a matter of public concern that requires a public response -- for the safety of workers, consumers and the public at large," Berceau wrote to agency heads last month.

    Though some Wisconsin state-level agencies are already probing nanotechnology environmental, health and safety issues, Berceau thinks that a registry would formalize an approach with pooled resources.

    In her letter, Berceau refers to similar measures developed or discussed in Berkeley, California, Cambridge, Massachusetts and within the Environmental Protection Agency’s Nanoscale Materials Stewardship Program. The registry would collect data on the type, physical state, monitoring, handling and disposal of nanomaterials.

    A proposed registry would take into account the need for the confidentiality of business information. Berceau leaves up to the regulatory agencies to proceed with the proposal through legislation or rule-making.

    The Project on Emerging Nanotechnologies’ U.S. NanoMetro Map shows less than 15 companies and academic institutions involved in nanotechnology in Wisconsin. It is uncertain whether the registry would only apply to companies manufacturing nanotechnology or nanomaterials within the state or also to those companies importing nanomaterials into the state in the form of consumer products or raw materials.

    Wisconsin joins Berkeley, Cambridge, and New South Wales (Australia) as states and municipalities considering regulating and monitoring nanotechnology in some form in addition to federal and central government efforts. In the future, it will be interesting to see if such efforts compete with each other to cause confusion or preemption.
  • Have you wondered where the regulation of nanotechnology is headed? The Nanotechnology: The Future of EHS Regulatory Policy Conference, slated for March 20, 2008 in Baltimore, Maryland will feature leaders in public policy who will share their views on corporate and regulatory governance related to developing an environmental, health and safety framework for the nanotechnology products of the future. The conference is co-sponsored by NanoReg® and Keller and Heckman LLP.
  • The Department for Environment, Food and Rural Affairs (Defra) has released a second report on the status of the United Kingdom’s nanotechnology EHS research. While off to a good start, the government research still has a long way to go.

    The United Kingdom government will have funded about Ł10 million of research between 2005 and 2008 on the EHS implications of nanotechnology. However, the report, Characterising the Potential Risks posed by Engineered Nanoparticles: A Second UK Government Research Report recommends a more focused effort on metrology and characterization research since it underpins much of the other research needed to evaluate the potential risk of engineered nanoparticles.

    Through a collaborative effort between government departments and agencies, the research councils and industry, research directed at the original objectives can be increased in the future. The report also summarizes and hopes to increase international levels of cooperation with the Organisation for Economic Co-operation and Development (OECD) and the International Standards Organisation (ISO) to collaborate on research objectives.

    In October 2005, the UK Government published Characterising the potential risks posed by engineered nanoparticles: A first UK Government research report, in which a set of 19 EHS research objectives were described together with ongoing research in this area and proposed research activities to be taken forward by the Nanotechnology Research Co-ordination Group (NRCG). This was followed in October 2006 by the publication of a report by Defra evaluating the progress made to meet these objectives.

    The report continues to address the uncertainties associated with nanotechnologies as set out in the Royal Society/Royal Academy of Engineering Report of 2004 Nanoscience and Nanotechnologies: Opportunities and Uncertainties which still serves to drive the agenda for the responsible development of nanotechnologies. The Royal Society responded to the report by suggesting the government has been slow to make progress.

    Since the Royal Society released the first report on nanotechnology for the United Kingdom government, they have been intimately involved in making sure that the government follows through on recommendations made. The Royal Society statement concluded by saying, “In order to speed things up we need to see stronger, clearer leadership from the government.”

    This report and the National Nanotechnology Initiative’s (NNI) most recent plan on research strategies show a sharp contrast. The Defra report is a progress report on research objectives set forth two years ago, while the NNI is still scrambling for acceptance of its own research strategy within Congress and among stakeholders.
  • The majority of consumers view the development of nanotechnology favorably. However, many are against the use of nanoparticles in food in a survey of 1,000 consumers commissioned by Germany’s Federal Institute for Risk Assessment (BfR).

    Consumers now seem to be much more familiar with the term “nanotechnology.” In 2004, 15 percent of respondents in a survey indicated that they had heard of the term but in the 2007 survey this figure rose to 52 percent.

    Sixty-six percent of the respondents still believe that nanotechnology offers more benefits than risks. This positive attitude towards nanotechnology does not, however, extend to all application areas. Support for consumer applications dwindles as consumer contacts with products have increased.

    Eighty-six percent of the survey participants approve of nanoparticles in paints and varnishes to increase their scratch and abrasion resistance while only 53 percent are in favor of using nanoparticles to improve cosmetic products.

    The majority of consumers are against the use of nanotechnology in food. Sixty-nine percent of the respondents reject the use of nanoscale additives in spices to prevent them from becoming lumpy. Eighty-four percent do not want any foods whose appearance has been rendered more appealing for longer times through the use of nanoparticles.

    The highest level of trust is enjoyed by consumer advocacy groups at 92 percent. The business community and politicians do not appear to be trusted by the majority of respondents. They are deemed to be trustworthy sources of information by only 32 and 23 percent of respondents, respectively.

    The BfR study of consumer attitudes about nanotechnology is divided into two parts. The first part examined consumer attitudes toward nanotechnology and its image with in-depth interviews of 30 consumers. The second part was a quantitative survey of 1,000 people. The final report will be published in the spring of 2008 and will be available on the BfR website.
  • It has often been said that “nanotechnology” seems to be everywhere these days and a recent study of media reports supports that view. The focus, however, shows a growing trend of media coverage from “gee whiz” to “oh my!”

    The Woodrow Wilson International Center for Scholars’ Project on Emerging Nanotechnologies recently presented findings by Sharon Friedman and Brenda Egolf of Lehigh University that the mass media coverage of nanotechnology has shifted in the U.S. from coverage of scientific findings to possible nanotechnology regulation.

    The study, Changing Patterns of Mass Media Coverage of Nanotechnology Risks, presented an analysis of mass media articles since 2000. One of the key findings was that articles about the regulation of nanotechnology risks doubled from 2005 to 2006.

    Almost 50% of articles in the U.S. with calls for regulation were by environmental groups, non-profits and think tanks. In the United Kingdom, the majority of these calls for regulation were by scientific and engineering societies and university scientists.

    The increase in news articles calling for additional nanotechnology regulation may be in response to several reports in this area released by Environmental Defense, Natural Resources Defense Council and the Project on Emerging Nanotechnologies in this time period. It is also evidenced by the proliferation of specialty nanotechnology academic journals. This proliferation leads to more noteworthy articles in those journals and less frequently in more mainstream academic journals, such as Nature or Science.

    It is also interesting to note that calls for new or tightened regulations have steadily increased in the United States but have been headed in the exact opposite direction in the United Kingdom since 2004.

    It will be interesting to see if nanotechnology risk coverage in the media continues to increase and whether it begins to compete with other pressing science issues.
  • The National Nanotechnology Initiative (NNI) strategy has been updated and calls for increased emphasis on the responsible development of nanotechnology seem to have been taken to heart.

    The interagency Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the National Science and Technology Council’s Committee on Technology, with support from the National Nanotechnology Coordination Office (NNCO), has released its revised NNI Strategic Plan. The original strategic plan was released in 2004.

    A key change in the plan is dividing the Societal Dimensions Program Component Area (PCA) into two PCAs in the updated plan: Environment, Health and Safety; and Education and Societal Dimensions. This change aligns with budget reporting practices and the formal rearrangement may lead to better funding of the EHS component and better organization in allocating that funding according to NNCO Director Dr. Clayton Teague.

    “This strategic plan presents an overview of the NNI for the public and will facilitate achievement of the NNI vision by offering guidance for agency leaders, program managers, and the research community in their nanotechnology R&D investments and activities,” said Dr. Teague.

    The strategic plan is divided into four strategic goals and eight program component areas. The four strategic goals are a high-level overview of the NNI’s objectives for the next three years and the program component areas group together similar activities critical to the four strategic goals.

    In the previous strategic plan, the responsible development of nanotechnology was a major emphasis of the NNI. With this strategic plan, this focus has been maintained. The plan indicates that the NNI “aims to maximize the benefits of nanotechnology and at the same time to develop an understanding of potential risks and to develop the means to manage them. Specifically, the NNI pursues a program of research, education, and communications focused on environmental, health, safety, and broader societal dimensions of nanotechnology development.”

    The 2008 budget request for the NNI is $1.44 billion while the request for research specifically focused on EHS is $58.6 million. While a significant increase over funding in recent years, it still falls short of funding levels recommended by several non-governmental organizations.
  • Steffen Hansen and his colleagues at the Technical University of Denmark noted the content of hundreds of nanotoxicology articles and developed a methodology that deals with a basic concern of nanotechnology. With respect to nanomaterials and their toxicity, what makes them different or alike?

    A Nanotoxicology article proposes a method to categorize nanomaterials and their most important chemical properties. An extensive literature review of 428 studies was then used to highlight the research gaps for hazard identification.

    The article highlights three different categories of nanomaterials: nanoparticles produced in bulk, nanomaterial films or surfaces and nanomaterials within other materials (e.g., air, solids and liquids). Each of these three principal categories has subcategories. These categories of nanomaterials are then compared with a set of physical and chemical properties found to be relevant for nanomaterials. These properties were extrapolated from the literature and analysis on the topic. They are: chemical composition, size, shape, crystal structure, surface area, surface chemistry, surface charge, solubility and adhesion.

    For each of the nanotoxicology articles, the nanomaterials studied and the physical and chemical properties described were noted. This resulted in a table with the percentage of studies on a given nanomaterials that described its physical and chemical properties. For example, only 17 percent of all carbon nanomaterial studies noted the size of the carbon nanomaterials. For most nanomaterials, the size was often mentioned. Often times, the surface area, shape or crystal structure was never noted.

    The article also noted the focus of each nanotoxicology article. Most were concerned with cytotoxicity and mammalian toxicity; while there have not been many ecotoxicological studies or DNA-related toxicology studies.

    The importance of the study is the careful grouping of nanomaterials. Each category of nanomaterials may have different toxicological characteristics. The field of nanotoxicology may be to complex to paint broad brush strokes from one nanomaterial to all others. It also shows that areas of nanotoxicology, such as the ecotoxicology of nanomaterials, have been neglected thus far.
  • New England is once again moving toward a manufacturing economy but this time it may be based on nanotechnology and worker safety guidance is becoming very important.

    The Project on Emerging Nanotechnologies has released a research brief conducted by the University of Massachusetts-Lowell on a survey of New England nanotechnology companies. They found that while firms acknowledge the potential environmental, health and safety (EHS) risks of nanotechnology, they do not have enough information or guidance for risk management.

    Researchers conducted a web-based survey of 180 managers in nanotechnology firms with 43 firms responding. Then, 12 respondents were interviewed in a follow-up to the web-based survey.

    Eighty percent of large firms responded that they were taking steps towards EHS risk management of nanotechnology, while only 63% and 33% of small- and medium-sized firms, respectively, were taking similar steps.

    When respondents were asked about barriers to EHS risk management, 50% cited a lack of information needed to quantify risk. A third of respondents, all small- and medium-sized firms, believed no additional EHS risk was associated with nanotechnology.

    Most respondents found that the internet and Material Safety Data Sheets were the best medium and source of information for risk management.

    When follow-up interviews were conducted, the companies responded that they did not incorporate nanotechnology-specific risk management policies or practices. This survey shows that the small- and medium-sized companies may be ill-informed of EHS risks associated with nanotechnology. This could be due to their lack of resources to seek more information or guidance.

    Reliance on the internet and Material Safety Data Sheets as the prime sources for EHS risk information could lead to misinformation on nanomaterial hazards. The survey results suggest that trade organizations and academic researchers could use the internet to quickly spread reliable EHS risk information on nanotechnology.
  • Organisation for Economic Co-operation and Development (OECD) member countries and other stakeholders are pooling expertise and funding testing of nanomaterials to produce environmental, health and safety (EHS) risk information.

    A program has been established to test nanomaterials such as carbon nanotubes, fullerenes and cerium oxide with additional nanomaterials to be included in the future. The testing program includes characterization of physical-chemical properties, environmental degradation and accumulation, environmental toxicology and mammalian toxicology.

    As nanomaterials are often new forms of traditional chemicals, the OECD Test Guidelines for the Safety of Chemicals will form the basis for testing. These tests will provide, in addition to providing EHS information, an evaluation of the suitability of OECD Test Guidelines for nanomaterials. New or amended guidelines will be developed, if current guidelines are found inadequate. OECD will review the program in June 2008.

    The OECD’s Working Party on Manufactured Nanomaterials will manage the program. OECD has already published two substantial reports detailing the efforts of governments and other stakeholders to address safety issues.

    The Working Party on Manufactured Nanomaterials was established in 2006 to help member countries address the EHS implications of nanotechnology. The testing program is one of six projects managed by the Working Party on Manufactured Nanomaterials. The others are: an OECD Database on EHS Research; Research Strategies on Manufactured Nanomaterials; Manufactured Nanomaterials and Test Guidelines; Cooperation on Voluntary Schemes and Regulatory Programs; and Cooperation on Risk Assessment.
  • Australia seems to be following a path similar to the United States. Without a national approach to the regulation of nanotechnology, state governments are taking an increasingly active role in the process.

    New South Wales' Parliament has asked its Standing Committee on State Development to provide a report on a list of concerns about nanotechnology. This list includes items, such as “the health, safety and environmental risks and benefits of nanotechnology, and the appropriateness of the current regulatory frameworks in operation for the management of nanomaterials over their life-cycle.”

    Verity Firth, State Science Minister, commented that “before the technology's full potential can be released, safety and ethical concerns need to be assessed by governments.”

    The Terms of Reference for the inquiry also includes points on nanotechnology applications in development in the state, the adequacy of nanotechnology education and workforce development, Australia’s National Nanotechnology Strategy’s context for New South Wales and public understanding of nanotechnology.

    New South Wales is Australia’s most populous state and home to the country’s capital, Sydney. The National Nanotechnology Strategy is the Australian government’s initiative for nanotechnology. Similar to the U.S. National Nanotechnology Initiative, the Australian government has spent over $21 million (AU) on research and development.

    According to the Terms of Reference, the Standing Committee on State Development must report back to Parliament by October 31, 2008. The inquiry will also be taking public comments until March 28, 2008.

    State and municipal initiatives to investigate the environmental, health and safety (EHS) implications of nanotechnology are beginning to create momentum. New South Wales joins U.S. cities Berkeley and Cambridge, as being the first non-federal or central government actors to conduct their own inquiries. At the international level, the OECD and European Commission are also investigating nanotechnology’s EHS implications from different perspectives. This creates an interesting mosaic of steps toward regulation at the municipal, state, federal and international levels.

    At any level, the government’s attempt to regulate nanotechnology in a meaningful, different way could set a minimum standard for other governments to follow.
  • The most comprehensive effort to examine worker safety has been led by the National Institute of Occupational Safety and Health (NIOSH) and it’s beginning to show some benefits.

    NIOSH has released for peer review a draft Current Intelligence Bulletin, Interim Guidance for the Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles.

    The main recommendations note that the potential occupational hazards associated with exposure to engineered nanoparticles need more study. NIOSH acknowledges that “No substantial link has been established between occupational exposure to engineered nanoparticles and adverse health effects.”

    Even though the link has not yet been established, the draft recommends several precautions. First, workplaces should take practical measures to control exposures, as covered in the Approaches to Safe Nanotechnology: An Information Exchange with NIOSH.

    Second, employers should identify tasks and areas that could lead to worker exposure to engineered nanoparticles. This will form the basis for future control measures, as recommended or needed.

    Finally, while the draft acknowledges the lack of evidence necessary to recommend medical surveillance, employers should consider its use. This would verify the effectiveness of current control measures.

    Medical surveillance involves many different elements, but the basic goal is to collect medical information on workers and workplace exposures. Once information is collected, hazards and exposures are easier to identify and control.

    NIOSH will hold a public meeting to discuss the draft on January 30, 2008 in Cincinnati. Public comment will also be accepted online until February 15, 2008. Peer reviewers and the public are asked to assess the draft’s reasoning and conclusions in the context of best practices of industrial hygiene.
  • The Synthetic Organic Chemical Manufacturers Association (SOCMA) has appointed John DiLoreto as the new Director of its Nanotechnology Small and Medium Enterprises (SME) Coalition.

    The Coalition was created to assist start-ups, small and medium enterprises that are developing, manufacturing and using nanoscale materials. The Coalition will inform and provide perspective regarding the health, safety and environmental aspects of nanotechnology to the Environmental Protection Agency (EPA), the Occupational Health and Safety Administration (OSHA), the Food and Drug Administration (FDA) and other U.S. agencies in addition to international regulatory initiatives such as REACH.

    Mr. DiLoreto publishes the NanoReg Report and he is the founder of NanoReg, a professional services company specializing in emerging environmental, health and safety issues surrounding nanotechnology. He is the creator and former Director of the American Chemistry Council’s Nanotechnology Panel.

    “John’s background and experience make him an excellent choice as Director for the Coalition,” said SOCMA president, Joe Acker. “He has the proper knowledge of the development, uses and manufacturing processes of nanoscale materials. This will be invaluable in helping both our Coalition members and policymakers understand the impacts of potential new rules on industry.”

    “This is a tremendous opportunity to work on nanotechnology issues with an important industry stakeholder” said John DiLoreto, new Coalition Director.

    As Director, Mr. DiLoreto will direct the Coalition’s efforts to: promote a positive public perception of nanotechnology; advocate the needs and interests of start-ups, small and medium-sized enterprises before policymakers; establish consistency and accuracy in developing standards, definitions and nomenclature; and secure fair treatment in trade.

    The Coalition is open to all companies, regardless of SOCMA membership. Interested parties may contact John DiLoreto, at (301) 987-0924 or johnd@nanoreg.net. They may also speak with Tucker Helmes, Director of the SOCMA Visions Department at (202) 721-4154 or helmest@socma.com.

    The Visions Department manages various affiliated associations and consortia. They address specific chemical or process advocacy, regulatory, testing, stewardship or technical issues that are of common concern or interest to a particular sector of the chemical industry. Each group is managed independently with its own membership, budget and governance.
  • In a workshop of more than two dozen scientists, two key questions were the focus of discussions: what information is needed to understand the human health impact of engineered nanoparticles and how is this information best obtained?

    During the workshop, held at the Project on Emerging Nanotechnologies in Washington D.C., the participants developed lists of critical needs in the following areas: extensive physicochemical characterization, capacity for macromolecular perturbation, potential for unintended carriage of toxic molecules, translocation, agglomeration state and chemical composition.

    The group concluded that tests should be developed to uncover hazardous properties. Given the large number of diverse materials, most participants favored a tiered approach. Over the long term, research should be aimed at developing an underlying understanding of nanoparticle toxicity and properties associated with it.

    Research needs should be determined in the context of the current availability of testing methods for nanoscale particles. Finally, the group identified general policy and strategic recommendations for hazard assessment research on nanoparticles.

    The recommendations, detailed in a Meeting Report: Hazard Assessment for Nanoparticles – Report from an Interdisciplinary Workshop in the November issue of Environmental Health Perspectives, began with suggesting a master research plan for assessing and understanding the human health risk associated with nanoparticles. The plan should also sponsor workshops on the particular characteristics associated with nanoparticle toxicity.

    It was suggested that this workshop information should be shared in an interdisciplinary forum. Eventually, there should be an established series of toxicological tests and baseline information for commercial products with nanoparticles. This process of information gathering and sharing on nanotoxicological testing should be administered by a third-party organization.
  • Despite a great deal of publicity on the potential risks of nanotechnology, the public does not seem to be as worried as scientists according to a new study.

    The study, published in the current issue of Nature Nanotechnology, was carried out by Dietram Scheufele, Sharon Dunwoody, Tsung-Jen Shih and Elliott Hillback of the University of Wisconsin-Madison and Elizabeth Corley and David H. Guston of Arizona State University.

    While scientists were generally optimistic about the potential benefits of nanotechnology, they expressed significantly more concern about pollution and new health problems related to the technology. Potential health problems were the highest rated concern among scientists.

    On environmental pollution concerns, 20% of scientists indicated a concern about nanotechnology and pollution, while only 15% of the public thought the same. Roughly 30% of scientists indicated a concern about nanotechnology and human health risks while only 20% of the public felt the same way.

    The study surveyed 1,015 US adults and 363 nanotechnologists this year. The overwhelming majority of nanotechnologists saw the positive environmental and human health benefits from nanotechnology.

    In contrast to the divide on environmental and public health concerns, the general public was more worried about job losses and privacy concerns attributed to nanotechnology while scientists were not as worried about these issues.

    Given the scientists’ concerns about nanotechnology, this may be one of the rare times that the scientists are more alarmed about technology development than the general public. If the risks are ultimately realized, this could put scientists in the unfamiliar position of explaining the risks about technology that they are involved in developing.
  • Since the release of SwissRe’s report on nanotechnology in 2004, insurance companies have been analyzing the unique issues presented by nanotechnology’s technical issues.

    Lloyd’s recently released Nanotechnology: The Big Questions, which was to be discussed in a seminar with stakeholders on December 10, 2007. Reminded of previous insurance disasters, like asbestos and environmental issues, insurance companies are becoming wary of nanotechnologies, especially in consumer products and occupational exposures.

    According to Trevor Maynard, Manager of Emerging Risks at Lloyd’s, “Nanotechnology presents the insurance industry with both an emerging market and an emerging risk. The Lloyd’s report and the Lighthill Risk Network conference will provide underwriters with an ideal opportunity to increase their knowledge of nanotechnologies. We hope underwriters, involved in product liability and in assessing risk and capital requirements relating to latent claims, will attend.”

    The brief is a prelude to a planned report on nanotechnology by Lloyd’s Emerging Risks team to address some of the questions highlighted in its brief.

    Aside from providing a new industry to insure, it is also important to note that nanotechnology could bring direct benefits to risk mitigation in the form of new materials that are stronger or more adaptive. These risk mitigation technologies could touch industries from automobiles to medicine.

    On the other hand, the brief reports that there is some data on the environmental and public health hazards for nanotechnology, but there simply is not enough data. At worst, this could lead to unexpected loss of life, health issues, worker’s compensation, physical damage, and environmental pollution losses.

    For the successful adoption of nanotechnology in industry, insurer and re-insurer support is essential for buttressing financial investment risks in new product development. If insurer support wanes, big and small companies may not be able to sustain the risks of producing nanotechnology-enabled products.
  • The lack of new regulations has prompted the creation of nanotechnology risk frameworks and voluntary initiatives on risk assessment. Learning from past lessons, the present efforts may prove difficult for a number of reasons.

    Many government and other non-governmental organizations have been developing their own frameworks for managing nanotechnology. In government, the Department of Environment, Food, and Rural Affairs (DEFRA) in the UK has established a voluntary initiative on nanomaterials – enlisting participants to provide information on their products to the government. The latest quarterly update reported only nine submissions to date.

    In the U.S., the Environmental Protection Agency (EPA) has proposed a similar program, the Nanoscale Materials Stewardship Program (NMSP). Environmental Defense and DuPont collaborated on a risk management framework for nanomaterials, the Nano Risk Framework. More recently, there have been news releases on other collaborative efforts to address nanotechnology’s risks.

    In Germany, the federal government has made it part of the nanotechnology research strategy to consider the possibility of voluntary reporting scheme like the UK DEFRA program. The European Union has launched a consultation effort on a voluntary code for the responsible development of nanotechnology products. Finally, the Nanotechnology Industries Association in Europe in collaboration with other stakeholders is enlisting support to develop a Responsible NanoCode.

    Voluntary initiatives for nanotechnology could benefit from lessons learned from previous similar programs. The recent Nanotechnology Law & Business article The Challenges of Adopting Voluntary Health, Safety and Environment Measures for Manufactured Nanomaterials: Lessons From the Past For More Effective Adoption in the Future by Steffen Hansen and Joel Tickner highlights the lessons learned from over 200 previous voluntary environmental initiatives in the U.S. Resources for the Future has also released the book, Reality Check: The Nature and Performance of Voluntary Environmental Programs in the United States, Europe, and Japan.

    To be successful, voluntary initiatives should be interpreted with consistency, encourage widespread adoption, have measurable results and drive continuous improvement and learning. Typically, voluntary initiatives offer incentives, such as recognition, publicity, certification, technical assistance and regulatory incentives to increase involvement and provide the right reasons for industry to participate. In cases where industry involvement is low, non-participating companies can be pressured with negative publicity and be blocked entry to valuable resources or groups.

    If the voluntary initiative does not provide the information needed to evaluate safety, test rules might be required. While understandably hesitant to dwell on this possibility before the Nanoscale Materials Stewardship Program even gets off the ground, EPA officials have broached the topic in recent days as an alternative approach.
  • Ahson Wardak, who has held research positions at the Woodrow Wilson Center’s Project on Emerging Nanotechnologies, Rice University’s Center for Biological and Environmental Nanotechnology and Environmental Defense, has recently joined NanoReg as an Associate. He was also previously with ENVIRON International’s nanotechnology practice as the Initiative Coordinator.

    With the continued growth and success of the NanoReg Report and professional services provided by NanoReg, Mr. Wardak has become actively engaged in the preparation of the NanoReg Report as a researcher and author of individual articles for several recent issues.

    Currently a PhD candidate in the University of Virginia’s Department of Systems & Information Engineering, Mr. Wardak received his MS in Systems & Information Engineering and his BS in Electrical Engineering from the University of Virginia

    With David Rejeski of the Project on Emerging Nanotechnologies, Mr. Wardak wrote one of the first papers on nanotechnology and regulation in October of 2003. With his diverse expertise, he brings an understanding of stakeholder viewpoints on nanotechnology from industry, government and non-governmental organizations.

    At NanoReg, Mr. Wardak will be in involved in a variety of nanotechnology projects involving regulatory compliance, occupational safety and strategic planning.
  • The European Food and Safety Authority (EFSA) says that it will not be able to meet a March 2008 deadline set by the European Commission for a complete generic risk assessment of nanotechnology.

    EFSA cites the challenges of data scarcity and vast range of applications and nanomaterials for the delay. Despite not being able to meet the deadline, EFSA will attempt to issue an opinion on nanotechnology with a working group of member states by the summer of 2008. It is not clear if the opinion would issue recommendations for further research and testing or simply be a preliminary opinion on the topic.

    According to a survey of 15 countries, there are about 70 practical applications of food in nanotechnology. Most applications fall into one of two categories: packaging or ingredients. Current packaging applications include anti-microbial plastic packaging, while food ingredients and supplements include nanomaterials with increased surface area for better absorption during digestion.

    In an attempt to alleviate the pressure to produce a generic risk assessment for nanotechnology, the European Commission is looking to integrate risk assessment and regulation into existing frameworks, such as the regulation of novel foods or food additives and enzymes. This still leaves a gap in attempting to assess the risks of nanotechnology and nanomaterials in food packaging materials.

    The European Commission and EFSA may ultimately find it impossible to find an all-encompassing risk assessment for nanotechnology and undertake a piecemeal approach instead.
  • The Environmental Protection Agency (EPA) has spent millions of research dollars on the applications and implications of nanotechnology.

    In a recent issue of the Journal of Environmental Monitoring, Nora Savage, Jeremiah Duncan, and Treye Thomas covered the EPA’s current research efforts on the applications and implications research for nanotechnology. The EPA has been at the center of the nanotechnology regulations discussions over the past few years.

    The agency has recently been dealing with development of the Nanoscale Materials Stewardship Program and regulation of silver nanoparticles as an antimicrobial in washing machines. Under this pressure and scrutiny, it is easy to overlook that they fund nanotechnology research in addition to overseeing its regulatory responsibilities.

    Since 2002, the U.S. EPA has been funding research on the environmental aspects of nanotechnology through its Science to Achieve Results (STAR) grants program. In total, more than $25 million has been awarded for 86 research projects on the environmental applications and implications of nanotechnology.

    Applications research has a focus on how nanotechnology can benefit the environment. The research areas for applications research include green manufacturing, environmental remediation, environmental sensors and treatment.

    Implications are meant to address environmental and public health effects attributed to nanomaterials. The funding categories for implications are nanomaterials in aerosol, exposure assessment, environmental fate and transport, life-cycle analysis and nanotechnology toxicity. Roughly sixty percent of the funding is going towards implications research of nanotechnology

    Future goals of EPA’s STAR program for nanotechnology include the continued involvement of other federal agencies in funding solicitations, international collaboration on research funding and the formation of a comprehensive research strategy for nanotechnology.

    For the EPA, nanotechnology is a two-sided coin, where the risk and benefits should be considered holistically. The research funding has done just that and looks to continue the same approach.
  • The Business and Industry Advisory Committee (BIAC) to the Organisation for Economic Co-operation and Development (OECD), the officially recognized representative of the OECD business community, has created a special group of industry representatives to address the international regulatory and safety aspects of nanotechnology.

    For the OECD’s Working Party on Manufactured Nanomaterials, the BIAC Executive Board approved the creation of the BIAC Expert Group on Nanotechnology. The Expert Group is expected to send a large delegation to the November 28th-30th meeting of the Working Party on Manufactured Nanomaterials, which will offer government and business participants an opportunity to discuss the current six main projects.

    Included among the projects are: 1) OECD Database on EHS Research; 2) Research Strategies on Manufactured Nanomaterials; 3) Safety Testing of a Representative Set of Manufactured Nanomaterials; 4) Manufactured Nanomaterials and Test Guidelines; 5) Cooperation on Voluntary Schemes and Regulatory Programs; and 6) Cooperation on Risk Assessment.

    Terry Medley, DuPont’s Global Director of Corporate Regulatory Affairs, will Chair the Expert Group and Richard Johnson, Senior Partner of Arnold & Porter will be the Vice-Chair.

    The OECD has ramped up involvement in nanotechnology oversight discussions at the international level since holding a special session on nanotechnology in Paris on June 7, 2005. This led to an OECD Workshop on the Safety of Manufactured Nanomaterials, which was held in Washington D.C., December 7-9, 2005.

    In September 2006, participants in an OECD forum on chemical safety established a Working Party on Manufactured Nanomaterials to address the implications of the use of nanomaterials on human health and environmental safety.

    In March 2007, participants in the OECD's Committee for Scientific and Technological Policy established a Working Party on Nanotechnology to promote international cooperation on research, development, and responsible commercialization of nanotechnology.

    At this point, the OECD would appear to be the most consistent international discussion forum for nanotechnology oversight. For industry, the BIAC Expert Group on Nanotechnology becomes a major powerbroker for industry with the governments and non-governmental organizations of 30 countries.
  • The White House has released “generally applicable principles” for nanotechnology oversight by the Federal government.

    In a two-page memorandum released jointly by the Office of Science & Technology Policy (OSTP) and Council on Environmental Quality (CEQ) on November 8, 2007, the Administration shared its Principles for Nanotechnology Environmental, Health and Safety Oversight.

    While it is not clear what precipitated the release of the memorandum, in the last several months non-governmental organizations and Congressional hearings have been turning up the heat on the Administration to develop a nanotechnology oversight strategy. It might also have been released because the National Nanotechnology Initiative (NNI) is up for review next year.

    The memorandum lists six principles of oversight under the headings of Purpose, Current Understanding, Information Development, Risk Assessment and Risk Management, International and Regulatory Path Forward.

    Under Current Understanding, the memo reiterates what several regulatory agencies have been saying for the last few years. “The Federal government’s current understanding is that existing statutory authorities are adequate to address oversight of nanotechnology and its applications. As with any developing area, as new information becomes available the Federal government will adapt or develop additional oversight approaches, as necessary, to address the area of nanotechnology.”

    As it stands, the Administration is not likely to produce new regulations specifically for nanotechnology any time soon, because current knowledge is seen as adequate.

    Under Regulatory Path Forward, it is apparent that a free market approach is being taken towards nanotechnology regulation, where “the benefits of regulation should justify their costs.” The memorandum indicates that these principles should be followed to provide appropriate research and development of nanotechnology oversight at the Food and Drug Administration, Environmental Protection Agency, National Institute for Occupational Safety and Health and the Occupational Safety and Health Administration.

    Interestingly, there is no mention of the Consumer Product Safety Commission or the NNI. In the latest Congressional hearings, expert witnesses challenged the ability of the NNI to oversee the environmental, health and safety implications of nanotechnology under its current structure, but the memorandum does not address those criticisms.
  • Another major nanotechnology conference will be taking place in Silicon Valley and NanoReg’s John DiLoreto, a nationally known expert on regulatory policy and environmental, health and safety issues will share his thoughts on the regulation of nanomaterials.

    Scheduled for Friday, November 16, 2007, DiLoreto will make a presentation on The Regulation of Nanomaterials as part of Small Times’ NanoCon International to be held at the Santa Clara, CA Convention Center.

    The presentation will take an in-depth look at regulations impacting the production and use of nanoscale materials. Key elements of the Toxic Substances Control Act (TSCA) will be highlighted for insight on the EPA’s chemical review process and how nanomaterials are evaluated for safety.

    The Nanomaterials Stewardship Program will also be discussed and an update on program activities and impacts will be provided.

    The conference will run through November 14-16, 2007 with pre-conference workshops on November 13, 2007.
  • Food safety is becoming a major nanotechnology issue and a recent European workshop highlighted regulatory challenges in evaluating the safety of nano-enhanced consumer products.

    In the first of a planned series of annual workshops, the European Commission’s Directorate General for Health and Consumer Products (DG SANCO) held the 1st Annual Nanotechnology Safety for Success Dialogue: the Food, Consumer, and Health Policy Perspectivein Brussels.

    DG SANCO Deputy Director General Paola Testori Coggi laid out the objectives for the Dialogue in her opening remarks: identifying the most relevant scientific, industrial and market developments; examining the developments and perspectives of nanotechnology risk assessments, discussing regulatory and policy perspectives on nanotechnology inside and outside the European Union; and establishing a common understanding of the priorities among a diverse set of stakeholders.

    The participants attended by invitation-only and included nanotechnology researchers, risk scientists, industry representatives, civil society representatives and public health experts.

    A main thrust behind the Dialogue was nanotechnology’s citation as a “core” global risk in the World Economic Forum’s 2007 Global Risks Report. The forum hosts the world’s top business leaders annually to discuss the world’s most pressing issues.

    As the DG SANCO continued to set the stage for the Dialogue, three prerequisites for nanotechnology’s success were identified: Nanotechnology products must be demonstrably when they are introduced into the marketplace; the regulatory framework should be correctly implemented to “allow a proper risk assessment and the implementation of risk management when needed”; and establishment of a coherent and collaborative approach on nanotechnology safety internationally.

    Deputy Director General Coggi said that DG SANCO would “build upon the results of the discussion in order to bring forward its nanotech action in the food, consumer and health policy areas.”
  • The Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) have concluded that current regulations are adequate to address safety issues related to the production and use of nanomaterials. According to the National Science Foundation’s (NSF) Senior Advisor on Nanotechnology, that may have to change with advancements in the creation of active nanostructures.

    On Friday November 9th, Mihail Roco presented his framework for nanotechnology’s future when he was interviewed by Robert Service, nanotechnology reporter at Science magazine, in a webcast hosted by the Project on Emerging Technologies. Topics in the interview ranged from the four generations of nanotechnology to regulation to food technology.

    According to Roco, the first generation of nanotechnology is the passive nanostructure, such as scratch-resistant nanostructured coatings for paint. The second generation is active nanostructures, where functionality can be turned on and off. One example is targeted cancer therapy that does not affect other parts of the body, like present forms of chemotherapy.

    Nanosystems comprise the third generation with the systems built by active sub-systems, such as the creation of artificial organs through nanotechnologies and biotechnologies. The fourth generation is the introduction of molecular nanosystems with bottom-up self-assembly. This could include, for example, nanoscale gene therapies and molecules designed to self-assemble.

    Using this framework, Roco commented that with additional knowledge we should be able to regulate nanotechnology with our present forms of regulation for the first generation of nanotechnology, passive nanostructures. We are currently experiencing only the first generation of nanotechnologies at the consumer products level.

    For the second and third generations, Roco indicated that proactive ways of addressing the societal impacts, including regulations, will be necessary.

    Asked about the suggestion that an environmental, health and safety guru be created for nanotechnology within the National Nanotechnology Initiative (NNI) structure, Roco thought that no one person or group could adequately address environmental, health and safety (EHS) implications. Roco indicated the strength of the current approach is the affiliation with other government agencies to address and answer key questions appropriately in-house.

    With regard to funding of EHS research with the NNI, Roco noted that the EHS implications of nanotechnology are in competition with many other issues, but that funding for safety research should keep pace with the issues.

    Roco thought that more attention should be paid towards ingestion and digestion of nanoparticles and nanomaterials, as skin penetration and inhalation are less likely or less harmful to human health in the presently available research.
  • There may not be a well-defined nanotechnology safety research strategy within the federal government but several agencies are doing what they can to gain insight into nanomaterial toxicity.

    The Center for Disease Control’s Agency for Toxic Substances and Disease Registry (ATSDR) has released a Federal Register notice for nomination of substances for further development of toxicological profiles with “nanomaterials” listed as a proposed substance.

    The ATSDR joins a growing list of government agencies at the state and federal levels taking a deeper look at nanomaterial toxicity. This focus has also led to the coining of the term “nanotoxicology” to describe the science and study of this research area.

    About 300 toxicological profiles have already been created which fill the needs of other government agencies, such as the Department of Energy and the Department of Defense. It would appear that the listing of nanomaterials is meant to attract nominations for specific nanomaterials rather than an attempt to lump all nanomaterials together. The list of previously profiled substances does include general classes of substances, such as gasoline and jet fuels.

    This annual list of proposed substances relies on three metrics: frequency of occurrence at National Priorities List (NPL) sites, toxicity, and potential for human exposure to the substances found at NPL sites. NPL sites are hazardous waste sites recommended by the Environmental Protection Agency for long-term funding and remedial action.

    In all likelihood, this may be another effort to use federal funding for the study of nanomaterial toxicity, as federal agencies and outside experts have publicly expressed frustration with current funding levels and lack of an effective research strategy.

    Public nominations for nanomaterials and other substances may be submitted until November 26, 2007.
  • While everyone is talking about the need for a comprehensive research strategy to better understand the environmental, health and safety (EHS) aspects of nanomaterials, the development of such a strategy has proven elusive.

    On October 31, 2007, the House Committee of Science and Technology’s Subcommittee on Research and Science Education heard for a third time that the National Nanotechnology Coordination Office (NNCO) has not yet established a comprehensive research strategy for the EHS implications of nanotechnology.

    At a previous hearing in September of 2006, Representative Bart Gordon called the NNCO’s Environmental, Health, and Safety Research Needs for Nanomaterials a “juvenile effort.” In addressing concerns about the quality of that document, the NNCO released a new interim document for this hearing to further focus the research efforts.

    Government experts updated the Subcommittee on their progress toward development of a research strategy. Clayton Teague, Director of the National Nanotechnology Coordination Office, offered a four-pronged implementation approach for a research strategy: successful coordination, comprehensive planning and guidance, leveraging forefront science through collaboration and periodic review. Floyd Kvamme, Co-Chair of the President’s Council of Advisors on Science and Technology, saw this past and present EHS research strategy for nanotechnology as “sound and appropriate”.

    Vicki Colvin, Executive Director of the International Council on Nanotechnology at Rice University, called on the NNCO to release a detailed strategy for EHS research no later than late 2008. Andrew Maynard, Chief Science Adviser for the Project on Emerging Nanotechnologies, called for the appointment of a single individual to oversee nanotechnology EHS research and regulation within the federal government with the appropriate resources.

    Richard Dennison, Senior Scientist at Environmental Defense alluded to a possible conflict of interest between the NNCO promoting nanotechnology and its ability to adequately address risks. He recommended a restructuring of the NNCO along the lines of comments by Andrew Maynard. Finally, Paul Ziegler, Chairman of the American Chemistry Council’s Nanotechnology Panel, recommended the National Research Council review the research strategy to establish a roadmap since the “current priority-setting process is slow and incomplete.”

    The outside experts agreed that continued public acceptance of nanotechnology is vital and increased risk research funding is needed. The Government’s experts, Teague and Kvamme, recommended keeping the NNCO’s structure intact, indicating that the present levels of funding represent an increase over previous years.

    Research and Science Education Subcommittee Chairman Brian Baird (D-WA) expressed his concerns in his opening comments. “The bottom line is that this is simply not an acceptable situation. We are basically still waiting for the EHS research strategy and detailed implementation plan that we were told would be available 18 months ago.”

    It was apparent that the series of hearings over the past two years has left the House Science Committee frustrated with the present level of effort and quickness in putting together a research strategy. They now seem eager to hear alternative approaches to constructing an EHS research strategy with a more definitive timetable.
  • What do nanoparticles and zebrafish have in common? Together they are helping to develop a growing database of the environmental effects of nanoscale materials.

    Four published peer-reviewed journal articles on recent research show that copper, carbon and silver nanoparticles can have a severe negative impact on zebrafish during developmental stages.

    Studies of aquatic toxicity often use zebrafish because they are small, inexpensive, and well-suited for whole-animal studies. Though there is not a formal link among the various studies, they add to a growing database of aquatic toxicity studies of nanoparticles.

    The copper nanoparticle study, Exposure to Copper Particles Causes Gill Injury and Acute Lethality in Zebrafish (Danio rerio), shows that copper nanoparticles can be acutely toxic and can damage the gills and the related gene expressions of zebrafish over a two-day period. The In Vivo Imaging of Transport and Biocompatibility of Single Silver Nanoparticles in Early Development of Zebrafish Embryos is a real-time study showing that embryos are highly sensitive to the presence of silver nanoparticles in water.

    In examining the Effect of Carbon Nanotubes on Developing Zebrafish (Danio rerio) Embryos, results showed that it might be metal contaminants, not the carbon nanoparticles that could be the cause of zebrafish embryos fatalities. In another study, Development Toxicity in Zebrafish (Danio rerio) Embryos After Exposure to Manufactured Nanomaterials: Buckminsterfullerene Aggregates (nC60) and Fullerol, zebrafish mortality increased when compared with other nanoparticles.

    The next steps in these studies are two-fold. First, there is a need to understand the particular properties involved that cause nanoparticles to be less or more toxic than other nanoparticles or their bulk counterparts. The study on fullerenes gives clues to coatings, but more study is needed for the metal nanoparticles.

    Second, these studies could give lessons to those studying the in vivo effects of nanoparticles on rats, mice and other small mammals. These will begin to shape an understanding of nanoparticle toxicity and its human health implications.
  • New guidance is now available following a joint survey on occupational health and safety in the handling and use of nanomaterials by the Federal Institute for Occupational Safety (BAuA) and the German Chemical Industry Association (VCI).

    The survey “was initially addressed to industrial manufacturers and users of nanomaterials, covering primarily products that had been manufactured and used for many years.” The survey did, however, include products still in the research phase to help develop the guidance document.

    The guidance document lists five steps as consistent with the state-of-the-art knowledge: information gathering, hazard assessment, determination of protection measures, review of effectiveness of measures, and documentation. In the document, a flowchart illustrates the decision-making process through these five steps, and the actions and documentation needed to be consistent with the guidance.

    This represents significant cooperation between the BAuA and the VCI that dates back two years to a discussion on synthetic nanoparticles. Since then the survey and workplace guidance document set the stage for a more specific list of guidelines and best practices to be released in the summer of 2008.

    This cooperation and guidance brings several questions to the forefront. Will such guidance be incorporated into any future REACH guidance on nanomaterials? What can other countries learn from this cooperation between government and industry?

    In the U.K. and U.S., voluntary programs on nanoscale materials have been difficult to implement and tougher to get industry buy-in. Both countries have released guidance on nanotechnology workplace safety. The National Institute of Occupational Safety and Health (NIOSH) previously released guidance in Approaches to Safe Nanotechnology: An Information Exchange with NIOSH.
  • A public solicitation for a grant has been released by the National Science Foundation (NSF) to create a new research center to study the effects of nanoscale materials on the environment.

    The Center for the Environmental Implications of Nanotechnology (CEIN) will be co-funded by the Environmental Protection Agency (EPA). Total funding for the center is expected to be $5 million per year for at least 5 years with NSF providing 80% of the funding.

    The solicitation indicates the “focus of this Center is on fundamental research and education on the interactions of naturally derived, incidental, and engineered nanoparticles and nanostructured materials, devices and systems with the environment and living world at all scales.”

    The CEIN’s goal is to understand the environmental, health, and safety implications of nanotechnology. The solicitation goes on to note that it is not limited to the research and testing of nanomaterial toxicity, but it could also extend into new methods for discovering the biological mechanisms of nanomaterials.

    It is interesting to note in the solicitation that the Center will only attempt basic research into the biological and environmental interactions of nanomaterials, with little mention of risk science and research. This basic research is meant to feed into the risk science community. While the proposal makes no mention of connecting the basic research on environmental implications to policy decisions, it can only be assumed that the research could ultimately have regulatory implications.

    The NSF, Department of Energy, Department of Defense and the National Institutes of Health have funded nanotechnology research in over 80 NNI-sponsored research centers across the country but none have a sole focus on the environmental, health and safety implications of nanotechnology.

    Every NSF-funded Nanoscale Science and Engineering Center has a research component related to the societal and ethical implications of nanotechnology. Rice University’s well-respected Center for Biological and Environmental Nanotechnology has a focus on discovery and development of nanomaterials that enable new medical and environmental technologies.

    Eligibility for the grant is restricted to U.S. academic institutions and non-profit, non-academic institutions in the U.S. such as independent museums, observatories, research labs, professional societies and similar organizations.

    The deadline for preliminary proposals for the CEIN grant is December 10, 2007. Preliminary proposals will be reviewed and evaluated to provide the basis for a second round of proposals on an invitation-only basis.
  • Consumers were given an opportunity to voice their opinion on nanotechnology, but did they take advantage of it?

    The Consumers Talk Nano web dialogue provided a venue for the public to discuss information and share their thoughts about the use and potential benefits and risks of nanomaterials. That was the goal of the collaboration of the Project on Emerging Nanotechnologies and Consumers Union, but experts seemed to dominate the discussion on nanotechnology in consumer products.

    The two-day online discussion covered topics ranging from an introduction to nanotechnology to next steps for nanotechnology oversight. According to a summary of the discussion “almost 250 participants across 23 states and 14 countries representing non-governmental, consumer, business, government, research, educational, science, engineering, media, and international organizations registered for the discussion. During the two-day dialogue, over 275 messages were posted in response to the queries and comments about nanotechnology.”

    However, only 20% of participants self-identified as consumers amongst the registered participants. Another indication of the insider-nature of the discussions is that 18% of the participants were from the Washington, DC area.

    Expert panelists facilitating the discussions included David Rejeski, Andrew Maynard, and Terry Davies of the Project on Emerging Nanotechnologies and Carolyn Cairns and Michael Hansen of the Consumers Union. Other experts not affiliated with the projects also participated in the discussions.

    An interesting outcome of the discussion was a poll on labeling products with nano-sized ingredients. Seventeen out of twenty respondents wanted nano-based products to be labeled as such. One interesting comment highlighted the need for labeling requirements and that we are, “reminded that the free market works, because consumers vote with their dollars, declining to purchase items which are unsatisfactory or do not meet their standards. This is not possible if the consumer is not informed.”

    The online dialogue also provided an interesting list of web links for more information on nanotechnology. Though it may have seemed somewhat like an online chat room for the nanotechnology policy community, it was an interesting concept for an open stakeholder discussion.
  • Decide, document, act. The mantra of the Nano Risk Framework has been put into practical use as DuPont introduces one of the products chosen for evaluation during development of the well-received Framework.

    One of three demonstration projects completed to evaluate the comprehensiveness, practicality, and flexibility of the Nano Risk Framework, DuPont™ Light Stabilizer 210 is an ultrafine titanium dioxide product designed to provide protection from ultraviolet light.

    The product is a white powder with 10-20% of the spherical and polyhedral particles smaller than 100 nanometers. The ultraviolet light-absorbing material will be used in a broad range of plastics applications including films, packaging, construction and transportation.

    DuPont generated a Nanomaterial Risk Assessment Worksheet for this product, addressed all of the base sets, completed a risk evaluation and selected risk management measures. This is the first nanomaterial product introduced by any company based on the Nano Risk Framework developed jointly with Environmental Defense.

    Environmental Defense and DuPont entered into a partnership to develop the Nano Risk Framework which was created by a multidisciplinary team from both organizations. Both parties “called for broad collaboration by interested stakeholders to identify and address potential environmental, health, and safety risks of nanotechnology.”

    In many ways, this represents another milestone of the partnership that first began about three years ago, but was formalized in the spring of 2005. Since then the partnership has posted an editorial in the Wall Street Journal and launched the Nano Risk Framework calling for the responsible development of nanotechnology. They now call on industry to adopt the Nano Risk Framework as DuPont has done internally for nanotechnology research and development.

    The Nanomaterial Risk Assessment Worksheet for Light Stabilizer 210 delves into the extensive detail of the Nano Risk Framework within the concept of a life cycle approach to risk. Though it may not be a risk assessment in a traditional sense, the document provides a significant quantity of information including physical characteristics, known hazards, exposure information and an evaluation of risks.

    This should be good news for smaller nanotechnology companies that want to utilize the Nano Risk Framework for their own nanomaterials, but may not have all the resources. The launch of this product demonstrates the practicality and flexibility of the Nano Risk Framework, and its effectiveness for making risk-based decisions will ultimately be judged after continued use with additional nanomaterial products.
  • While press coverage of nanotechnology regulation has seen blips of news articles at popular newspapers such as the New York Times and Washington Post, and technical journals such as Science, there has been very little coverage of the topic in nanotechnology industry publications.

    The most abundant news about nanotechnology has been new applications and the potential for nano-enhanced products. However, a small but growing number of articles have been appearing in the trade press and traditional news outlets.

    For example, Small Times Magazine has written extensively about the MEMS industry and, in recent years, has increased reports specifically on the development of nanotechnology. The most recent issue has four articles on nanotechnology policy including special reports on possible Food and Drug Administration regulation, the Environmental Protection Agency’s Nanoscale Materials Stewardship Program, the new Toxic Substances Control Act (TSCA) guidance on nanomaterials and the Environmental Defense-DuPont Nano Risk Framework.

    This issue marks serious coverage of nanotechnology regulation. It is important to note, as coverage within the nanotechnology business community grows, is this a turning point for the industry? Will focused coverage of regulation and risks trump the story about the positive applications of nanotechnology?
  • Move over ASTM, ANSI, ISO, and the Chinese Academy of Sciences. Here comes the British Standards Institute (BSI) with new nanotechnology standards.

    With several standard-setting organizations at various stages of development of nanotechnology standards, the British Standards Institute is the latest to join the crowded area. Seven Publicly Available Specifications (PAS) are being developed for publication on topics such as terminology and labeling. In addition, two Published Documents (PDs) are being developed as a guide to safe handling and disposal of free engineered nanoparticles and a guide to specifying nanomaterials.

    These publications will buttress the UK’s leading role in the development of nanotechnology standards at the international level. Currently, the UK holds chair and secretariat positions at International Standards Organization (ISO) and European Committee for Standardization (CEN) on nanotechnology standards development.
  • With no new nanotechnology regulations on the horizon, several groups have proposed guidelines for working with the products of nanotechnology. The latest code suggests seven guiding principles for every organization engaged in the production, use or retailing of nanotechnology products.

    The original idea for the most recent proposed code was the brainchild of discussions among the United Kingdom’s Royal Society, Insight Investment, Nanotechnology Industries Association and the Nanotechnology Knowledge Transfer Network.

    Recently, the Woodrow Wilson International Center for Scholar’s Project on Emerging Nanotechnologies hosted one of three planned consultations to provide opportunities for stakeholders to comment on the Responsible NanoCode.

    The objectives of the initiative are threefold: to develop a code of conduct for the nanotechnology industry; to establish a consensus on best practices; and to help organizations align themselves with these best practices. The Code does not intend to replace regulation, but to help maintain trust among stakeholders on a certain set of business approaches towards nanotechnology.

    The seven principles of the Code center on a product development approach to responsible development of nanotechnology products. The principles urge member companies to engage the public, suppliers and business partners in discussions about the societal and ethical implications of nanotechnology.

    One interesting aspect to these principles is that sales and marketing functions within organizations are also encouraged to make strides towards responsible practices. Similar codes such as the Foresight Guidelines for Responsible Nanotechnology Development and the Environmental Defense-DuPont Nano Risk Framework have been developed echoing similar principles and approaches.

    Other consultations are planned with the Australian NanoBusiness Forum/NanoVic and the UK Social Investment Forum. The Code is available for public comment until November 12, 2007. In addition to commenting on the NanoCode, two additional questions are asked regarding the ability of organizations to adopt the Code and how to increase widespread adoption of the Code.
  • Much of the dialogue on potential risks posed by the production and use of nanoscale materials has centered on human health. A recent symposium held by the California Environmental Protection Agency (Cal/EPA) turned the discussion toward another critical facet of the dialogue – the environment.

    Cal/EPA’s Department for Toxic Substances Control (DTSC) recently held their second nanotechnology symposium with a focus on the potential environmental hazards of nanoparticles.

    This symposium solicited presentations from industry, non-governmental organizations, academia and government. The highly technical presentations covered state-of-the-art applications of nanomaterials and their potential risks and interactions with the environment. There were no easy answers, but the speakers offered frameworks for understanding the toxicology of nanomaterials, or nanotoxicology.

    In the morning session, NASA’s Cattien Nguyen spoke about the chemical properties and commercial applications of nanotechnology while Lutz Madler of the University of California, Los Angeles made a presentation on the physico-chemical characterization of nanoparticles and how these characteristics relate to biological interactions.

    The afternoon session centered on the potential risks posed by nanoscale materials. Environmental Defense’s Richard Denison offered one proactive approach towards understanding the risks of nanotechnology-enable products by describing the Environmental Defense-DuPont Nano Risk Framework. Justin Teeguarden of the Pacific Northwest National Laboratory also made a presentation on potential human health risks associated with nanomaterials.

    The first symposium in this series in March 2007 explored the potential promise and challenge of innovative technologies in California.
  • Approval ratings for any government agency are likely to be low when it comes to a divisive issue like regulation but when it comes to nanotechnology approval ratings for two key agencies continue to drop.

    The Woodrow Wilson International Center for Scholars repeated a survey on public awareness of nanotechnology and found that public perceptions have slightly changed in the last year. However, the public sense of government’s responsibility reflects a continued decrease in confidence.

    In large part, the survey examined public trust in government and industry to ensure the safety of nanotechnology, the perceived benefits and risks of nanotechnology and opinions on nanotechnology and food applications.

    After being informed about nanotechnology, the greatest increase in awareness occurs in the people that believe that the risks will outweigh the benefits. The report notes that “Informed assessment of the risks-versus-benefits tradeoff remains strongly tied to awareness of nanotechnology.”

    The latest conclusion about food applications of nanotechnology is that consumers have not yet formed an opinion. “The American public wants more information about the health risks and benefits of nanotechnology-enhanced food and food products before they will use them.”

    Though there were no major or statistically significant differences between the 2006 and 2007 surveys, the trends remain the same. When the public learns about nanotechnology, the survey suggests that they tend to see the risks outweighing the benefits. Furthermore, they do not trust government or industry to get it right, or with certain agencies, the public is ambivalent at best.

    The survey, conducted by Peter D. Hart Research Associates for the Project on Emerging Nanotechnologies, gave relatively high marks to the U.S. Department of Agriculture with 60% of those surveyed indicating the agency is doing an excellent or pretty good job. This is down from 67% in 2006 but the Environmental Protection Agency and Food and Drug Administration both have an approval rating of less than 50%.

    The Project on Emerging Nanotechnologies used this report to launch an upcoming partnership with Consumers Union called “Consumers Talk Nano.” On October 23-24, 2007 the public will have access to experts from the Project, Consumers Union and other academics in the field to discuss issues related to potential nanotechnology risks and safety.
  • The area of nanotechnology safety research has always been a hot issue among stakeholders. “More funding for research” has been a recurring theme and it now seems the funding is flowing in that direction with some regularity.

    In a volley of announcements, several nanotechnology safety research projects have gotten underway.

    Missouri University has initiated a new study to explore the effects that nanotechnology might have on the environment. The Environmental Protection Agency provided $399,506 to look at how nanomaterials might affect aquatic organisms.

    The U.S. Department of Energy’s Genome to Life Program awarded a grant to three law professors at Arizona State University’s Sandra Day O’Connor College of Law. The project is receiving $314,000 to develop models for the international regulation of nanotechnology.

    Researchers from the University of Oregon have been awarded a $1.6 million grant by the W.M. Keck Foundation to determine the effects of engineered nanoscale materials on animal tissues.
  • Without regulatory guidance, stakeholders are looking for constructive ways to responsibly manage the growth of nanotechnology. A voluntary initiative under development in the United Kingdom is proposing seven “good practices” that will provide the basis for strategic guidance that all organizations can follow.

    The Responsible Nano Code was drafted by a Working Group comprised of representatives from non-governmental organizations, academia and industry. The Royal Society, Insight Investment, The Nanotechnology Knowledge Transfer Network and The Nanotechnology Industries Association are the Founding Partners of the initiative to develop the Code.

    The Working Group is soliciting comments on the Code through the Code’s website until November 12, 2007.

    On Tuesday, October 9, 2007 the Woodrow Wilson Center will host one of three planned consultations scheduled to provide opportunities to comment on the Code. Participation in the consultation will also be available through a webcast. Other consultations are planned with the Australian NanoBusiness Forum/NanoVic and the UK Social Investment Forum.
  • The United Kingdom’s (UK) Department for Environment, Food and Rural Affairs (Defra) and European Nanotechnology Trade Alliance will conduct a policy workshop in London to provide updates on nanotechnology policy issues.

    The policy workshop will be held on October 19, 2007 to provide updates from the UK government on research progress from the Nanotechnology Research Coordination Group, Defra’s Voluntary Reporting Scheme, the Council for Science and Technology Report on government progress against nanotechnology commitments, international efforts and industry perspectives.

    The workshop is open to representatives of companies that are manufacturing, processing, developing, researching and/or marketing nanomaterials, nano-enabled products and nanotechnologies in general.
  • When the Environmental Protection Agency (EPA) decided to treat Samsung’s silver ion washing machines as a device rather than a pesticide, it set off a chain of events resulting in a reversal of that determination. A recent Federal Register notice clarifies the rationale for the reversal and puts all producers and distributors of similar equipment on notice.

    In September 2005, the agency determined that washing machines utilizing silver electrodes to produce silver ions for the pesticidal purpose of killing germs are considered devices rather than pesticides and do not require registration.

    The Agency revised its thinking in November 2006 after environmentalists and wastewater treatment plant operators expressed concerns over the possible impacts of the silver ions on the environment.

    Section 2(h) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) defines “device” as “any instrument or contrivance which is intended for trapping, destroying, repelling or mitigating any pest.” Section 2(u) of FIFRA defines “pesticide” as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.”

    In a 1976 Federal Register notice, EPA stated its statutory interpretation that the primary distinction between pesticides and devices was the means by which they achieved their pesticidal purpose. “If an article uses physical or mechanical means to trap, destroy, repeal [sic], or mitigate any [pest], it is considered to be a device. If the article incorporates a substance or mixture of substances intended to prevent, destroy, repeal [sic], or mitigate any pest, it is considered to be a pesticide.”

    Therefore, the key distinction between pesticides and devices is whether the pesticidal activity of the article is due to physical or mechanical actions or due to a substance or mixture of substances.

    The Federal Register notice of September 21, 2007 sets out deadlines for current producers and importers of such equipment to come into compliance. Equipment currently on the market may continue to be sold until March 21, 2008. By that time, an Application for Pesticide Registration Form (EPA Form No. 8570-1) must be submitted for the equipment.
  • There is more to nanotechnology than improved textiles and better baseball bats. A recent conference displayed a breadth of environmental nanotechnology applications and, in the process, brought significant attention to life-cycle thinking on nanoscale materials.

    The primary goals of the Environmental Protection Agency’s Pollution Prevention through Nanotechnology Conference were to point out application areas for further research in pollution prevention for nanotechnology, to investigate nanotechnology’s implications for pollution prevention applications and to inform regulation of nanotechnology by exploring its applications.

    An interesting session was on nanotechnology and life-cycle thinking. Lauren Heine from GreenBlue noted that nanotechnology's risks cannot be assessed but exposure and hazard information should be collected and disseminated in the interim. It was suggested that one gap in present life-cycle analysis methods is that they seldom benchmark themselves against other comparable technologies. For nanotechnology applications, it would be helpful to compare them against present alternatives, if any.

    Other speakers in this session included Dave Rejeski from the Woodrow Wilson Center’s Project on Emerging Nanotechnologies and Jim Hutchinson from Oregon’s Nanosciences and Microtechnologies Institute. Rejeski spoke about the need to identify risk, regulations and public reactions along a nanotechnology product life-cycle. Hutchinson spoke about the need to institute present “green” approaches to nanotechnology, such as the principles of green chemistry into product development.

    In contrast to environmental remediation applications of nanotechnology, the conference showcased applications that decrease pollution or energy incrementally. There was no mention of environmental remediation or environmental nanotechnology sensors, as there usually is when nanotechnology applications and the environment are usually mentioned.

    The technology tracks for the conference were organized into assessing the business, technology and public policy implications of particular pollution prevention technologies. The tracks focused on catalysts, flame retardants and batteries. Examples of applications discussed include solar energy, self-cleaning glass and nanotechnology processes to decrease energy use and reduce waste. For self-cleaning surfaces, cleaning chemicals would be used less often or not at all.

    Charlie Auer, EPA’s Director of the Office of Pollution Prevention and Toxics, asked the steering committee and attendees to suggest next steps. The steering committee is making plans for a consensus paper on recommendations and reflections for next steps for the EPA. Though there were minor references to regulations in several presentations, regulation of nanotechnology was not a major discussion topic at the conference.
  • The State of California has never been shy about taking a leading role in environmental protection and now the products of nanotechnology will be the focus of a discussion to examine potential environmental impacts.

    The Department of Toxic Substances Control is hosting the Nanotechnology Symposium II: Potential Hazards of Nanomaterials in the Environment to focus on nanoparticle ecotoxicity, nanomaterial human health risks, risk assessment, characterization of nanomaterials and their relation to bio-interactions.

    Those unable to attend the symposium in person will be available via webcast. The event will take place on Wednesday, October 3rd in Sacramento, California.
  • The Environmental Protection Agency’s continuing efforts to maintain a public dialogue on nanotechnology shifts gears from material characterization and regulation to environmental applications.

    The conference will focus on current practices and potential research areas in nanotechnology that incorporate the concept of pollution prevention in three major areas: Products that are less toxic, less polluting and wear-resistant; Processes that are more efficient and waste-reducing; and Processes and products that use less energy and fewer raw materials.

    The conference will begin with individual presentations on current and anticipated nanotechnologies with pollution prevention applications. Panel discussions on selected case studies will be held on the second day of the conference. Posters will be on display throughout the conference and will be featured during an evening reception and poster session.

    The Pollution Prevention through Nanotechnology Conference will be held at the Holiday Inn Rosslyn in Arlington, Virginia on September 25th and 26th.
  • The European Commission has fully supported the development of nanotechnology but it also understands the need to address the regulation of the rapidly growing applications of the technology.

    The Nanosciences & Nanotechnology Action Plan for Europe 2005-2009 was intended to provide the basis for boosting the quality of life and industrial competitiveness in Europe. The First Implementation Report 2005-2007 focuses on the Commission’s role as both policy maker and as funding body for research and innovation.

    The report addresses public health, safety, environmental and consumer protection issues using three different approaches; 1) Examining whether current legislative frameworks offer sufficient protection, or whether modifications or new legislation is needed; 2) Improving the knowledge basis, via research, scientific committees, information sharing and cooperation internationally; and 3) Involving the public through stakeholder dialogues and voluntary initiatives.

    In terms of a regulatory review, its initial finding is that “current regulation addresses in principle concerns about health and environmental impacts” but indicates regulatory changes may be proposed if scientific developments warrant such a change. Particular attention will be given to establishing mechanisms for regulatory action to deal with potential risks posed by products already in the marketplace.

    The next implementation report is expected to be released by the end of 2009.
  • Canadian officials are soliciting comments on a proposed two-phase approach to the regulation of nanoscale materials.

    The Canadian Environmental Protection Act of 1999 (CEPA 1999) is the primary regulatory tool for the regulation of chemical substances in Canada. CEPA 1999 establishes a legal regime for the assessment and management of chemicals and polymers which includes provisions for new and existing substances as well as information gathering and assessment powers.

    Under the provisions of CEPA 1999, the Ministers of the Environment and Health are required to conduct environmental and human health risk assessments and manage appropriately any risks arising from chemical substances entering the Canadian market.

    In a document released by Environment Canada and Health Canada in advance of a public workshop, a two-phase approach is suggested for a framework of nanomaterial regulations. The document, Proposed Regulatory Framework for Nanomaterials under the Canadian Environmental Protection Act, 1999, provides background on nanomaterials in addition to the suggested regulatory framework.

    Under the first phase of the proposed approach initiated in Fall 2006, Environment Canada (EC) and Health Canada (HC) will: Continue work with international partners to develop scientific and research capacities through the Organisation for Economic Cooperation and Development (OECD) and the International Standards Organization (ISO); Inform companies of their regulatory responsibilities under the current framework; Develop initiatives to gather information from industry on the uses, properties, and effects of nanomaterials; and Consider whether amendments to CEPA 1999 or the New Substances Notification Regulations (Chemicals and Polymers) (NSNR) would be needed to facilitate the risk assessment and management of nanomaterials.

    The second phase of the initiative to begin in 2008 includes; Resolution of terminology and nomenclature by ISO TC229; Consider establishment of data requirements under the NSNR specific to nanomaterials; and Consider the use of the Significant New Activity (SNAc) provision of CEPA 1999 to require notification of nanoscale forms of substances already on the Domestic Substances List.

    The proposed framework will be discussed at a public workshop to be held at the Holiday Inn Hotel in Toronto between 8:30 a.m. and 4:30 p.m. on September 27, 2007.
  • A group of scientists participating in an Environmental Protection Agency peer consultation were asked simple questions about nanoscale material characterization but there didn’t seem to be any simple answers.

    A dozen experts from the federal government, industry and academia discussed eighteen questions regarding “what data are known or reasonably ascertainable to characterize nanoscale materials.” The consultation was conducted to bring forward information which will allow the EPA to better understand nanomaterial characterizations provided by producers under the Basic Reporting phase of the Nanoscale Materials Stewardship Program (NMSP).

    The main discussion topics at the peer consultation included: 1) Types of Nanoscale Materials & Their Structures and Chemical Compositions; 2) Physical-Chemical Properties; 3) Nanoscale Manufacturing and Processing; 4) Impurities; and 5) Obtaining Characterization Data.

    The peer consultation had two goals. The agency wants “the currently available understanding of material characterization as it relates to nanoscale materials” and to use this information to guide the agency’s thinking on the Nanoscale Materials Stewardship Program.

    In preliminary responses to discussion questions by Panel members, DuPont’s Dr. David Warheit made some general observations that were echoed by several participants throughout the two-day meeting. “I would caution EPA, that in my opinion, many of the answers to the questions contained in the ‘Discussion Topics’ document are case-by-case and/or nanoparticle-type specific.” Warheit went on to say that “various subsets of nanoparticle-types are likely to require different answers to the same questions.”
  • Conventional thinking about the use of traditional risk assessment methods for nanoscale materials has been that the methods may be appropriate but some adjustments might be needed. The European Commission (EC) group asked to examine this issue is offering suggestions on the types of adjustments to make.

    The EC’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) was asked to provide an opinion on the appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies as presented in current technical guidance documents.

    In its modified opinion, the Committee agreed that the current methodologies described in the technical guidance documents are generally likely to identify the hazards associated with the use of nanoparticles. However, it was suggested that consideration be given to the way material doses are described since mass concentration may not be the best way to describe these materials when addressing dose-response relationships.

    Citing an absence of sufficient data on the fate and effect of nanoparticles on the environment, the Committee indicated it is “neither feasible nor appropriate to propose firm rules” on how to evaluate nanoparticles. Reevaluation of existing risk assessment methods for nanoparticles is recommended.

    Comments were provided by the American Chemistry Council, Austrian Umweltbundesamt, the UK’s Department for Environment, Food & Rural Affairs, Environmental Defense, Eucomed, U.S. Food and Drug Agency Nanotechnology Working Group, Henkel, International Council of Chemical Associations, the United Kingdom’s Nanotechnology Industries Association and several individuals and European companies.
  • The international effort to manage the safety of nanomaterial production and use is quietly moving forward.

    The Organisation for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials has released a report providing updates on current or planned activities by member countries related to the safety of nanomaterials. The document was circulated to OECD member country delegations as part of the Working Party’s 2nd meeting in Berlin, Germany in April 2007.

    Reports on activities were provided by 21 member country delegations, the European Commission, International Organization for Standardization, Woodrow Wilson Center for International Scholars and the Business and Industry Advisory Committee.

    One of the notable reports is the United Kingdom’s discussion on its Voluntary Reporting Scheme (VRS). As of August 2007 only six submissions have been received despite proactive efforts by the UK’s Nanotechnologies Industry Association (NIA). The NIA made personal appeals to its members to participate but concerns over the lack of available resources, confusion regarding the timing of submissions and anxiety over adverse publicity have limited participation in the program.

    The VRS is run by the UK’s Department for Environment, Food & Rural Affairs and is scheduled to end in September 2008.

    The European Commission has no plans for a voluntary program but the Seventh Framework Programme for research, technological development and demonstration activities was highlighted as a key research initiative to address the human health and environmental safety aspects of nanomaterials.

    With the European Union’s Registration, Evaluation & Authorization of Chemicals (REACH) program recently taking effect, it is highlighted as an important regulatory development and the EU Scientific Committee on Emerging and Newly Identified Health Risks consultation on risk assessment methodologies for assessing the risks of nanomaterials reflected one of several advances in developing technical guidance documents.

    Highlights of the United States activities include release of the Environmental Protection Agency’s White Paper on Nanotechnology and the agency’s scientific peer consultation on risk management practices. Also highlighted is the Nanoscale Science, Engineering, and Technology Subcommittee’s Nanotechnology Environmental Health Implications Working Group public meeting on an environmental, health and safety strategy and release of the National Institute for Occupational Safety’s Progress Toward Safe Nanotechnology in the Workplace.
  • The U.S. Food and Drug Administration (FDA) is proposing additional sunscreen protection information for the labels of sunscreen products but not to add specific information about products containing nanoparticles.

    Proposed enhancements to current labeling requirements include a new four-star rating system for UVA protection. Ratings would be derived from two tests the FDA proposes to assess the effectiveness of sunscreens in providing protection against UVA light.

    The first test measures a product's ability to reduce the amount of UVA radiation that passes through it. The second test measures a product's ability to prevent tanning. This test is nearly identical to the SPF test used to determine the effectiveness of UVB sunscreen products.

    Under the new rating system, one star would represent low UVA protection, two stars would represent medium protection, three stars would represent high protection, and four stars would represent the highest UVA protection available in an over-the-counter sunscreen product.

    UVA light is responsible for tanning and UVB for sunburn. Both can damage the skin and increase the risk of cancer.

    While the proposed new rule would also require a “Warnings” statement in the “Drug Facts” box for over-the-counter sunscreen products emphasizing the risk of skin cancer and premature skin aging caused by UV exposure, the FDA is not suggesting any new warnings about the inclusion of nanoscale materials in sunscreen products.

    An internal FDA Task Force on Nanotechnology previously recommended deferment of any new requirements for labeling of nano-enhanced sunscreens because the agency does not believe these products present any inherent hazards that would require labeling of all products. Instead, the agency has opted for consideration of such labeling on a case-by-case basis.

    The FDA has created a web site for the 2007 Sunscreen Proposed Rule which provides additional information on the proposed rule and a Summary of Key Points. Comments on the proposed rule may be submitted until November 26, 2007.
  • What are the appropriate priorities for conducting research on the safety of nanoscale materials? After an initial round of comments from stakeholders highlighting the lack of a coherent strategy, we may finally have an approach to the problem.

    A new document recently released for public comment identifies 25 specific priority research needs in 5 categories with a general ranking within each category. The five categories include: Instrumentation, Metrology, and Analytical Methods; Nanomaterials and Human Health; Nanomaterials and the Environment; Health and Environmental Exposure Assessment; and Risk Management Methods.

    Research needs are listed from highest to lowest for each category, with the exception of those presented in the category of Nanomaterials and Human Health. The Nanomaterials and Human Health task force gave equal weight to individual research needs under an overarching research priority for the category.

    The Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials has been released for public comment by the National Nanotechnology Coordinating Office (NNCO) on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council.

    The document uses three guiding principles in identifying the most appropriate research strategy: 1) Prioritize research based on the value of the information; 2) Where appropriate, seek to leverage research funded by other governments and the private sector; and 3) Use adaptive management for nanomaterial environmental, health, and safety research.

    The original document identifying environmental, health, and safety research needs was published September 21, 2006. A public meeting was held on January 4, 2007 to receive comments on the document and NSET members used the input provided by a broad range of scientists and other stakeholders to prioritize the research strategy.

    Comments may be submitted to the NSET Subcommittee through September 17, 2007.
  • What happens to nanomaterials when their useful life is finished? With so many nanomaterials in the marketplace, it’s no wonder that some are asking questions about the ultimate fate of nanoscale materials.

    If a nanomaterial is found to be hazardous and is released to the environment, it could be regulated as a hazardous waste under the Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) according to a report prepared by Linda Breggin and John Pendergrass of the Environmental Law Institute.

    The report, Where Does Nano Go? End of Life Regulation of Nanotechnologies, was recently released by the Woodrow Wilson International Center for Scholars’ Project on Emerging Nanotechnologies as the latest in a series of reports on the health and environmental implications of nanotechnology.

    The report authors left no doubt about the applicability of environmental regulations for nanomaterials. For example, if the nanomaterials meet the statutory definition of hazardous characteristics (corrosivity, ignitability, reactivity, toxicity) the substance should be regulated under RCRA and should also fall under the authority of CERCLA requirements.

    Recommendations in the report include suggestions that the EPA determine if specific nanomaterial waste is hazardous as defined by RCRA and to review traditional hazardous waste characteristics to determine if they are appropriate for nanomaterials.
  • Many in the U.S. have complained about priorities for nanotechnology safety research but the launch of a new consultation reflects similar concerns in Europe.

    As a prelude to a specific recommendation by the European Union Executive, a public consultation has been announced soliciting input from scientists, industry, policy-makers and the general public on nanotechnology research. While noting the enormous economic potential impact of nanotechnology, the consultation is intended to provide guidance on research that is designed to inform the governance of safe nanoscale material production and use.

    The Recommendation on a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research, highlights the Precautionary Principle indicating “the European Commission and the Member States should be invited to take all necessary steps to maintain a high level of protection of individuals, defining proper safety requirements.”

    The consultation will accept comments until September 21, 2007.
  • Environment Canada would appear to be on a parallel track with the U.S. Environmental Protection Agency on the regulation of nanomaterials.

    In a New Substances Advisory Note recently released by Bernarde Madé, Division Director of the New Substances Division, the note is to “inform manufacturers and importers of nanomaterials and any other stakeholders of the requirements for the substances under the New Substances Notification Regulations (Chemicals and Polymers).”

    The Domestic Substances List (DSL) provides the basis for determining if a substance is new. Substances already on the list do not require advance notice of manufacture or import into Canada. Nanoscale substances with unique structures or molecular arrangements are considered “new.” Examples given in the Advisory Note include fullerenes (considered new) and titanium dioxide (existing - already on the DSL).

    The New Substances Notification Regulations for chemicals and polymers require a risk assessment of its potential effects on the environment and human health prior to manufacturing or importation of any new substance.
  • The Food and Drug Administration (FDA) may not believe it needs any additional regulatory authority to deal with the products of nanotechnology but it does need a lot more science to make safety determinations according to an internal task force report.

    Last year, FDA Commissioner Andrew von Eschenbach created a Nanotechnology Task Force to determine regulatory approaches that encourage the continued development of innovative, safe, and effective FDA-regulated products that use nanotechnology materials.

    The Task Force was also asked to identify and recommend ways to address any knowledge or policy gaps that exist to better enable the agency to evaluate possible adverse health effects caused by the use of nanoscale materials.

    When reviewing the need for definitions of “nanoscale material” and “nanotechnology” for regulatory purposes, the Task Force took an increasingly popular approach in deferring until “FDA learns more about the interaction of nanoscale materials with biological systems and generalizable concepts that can inform the agency's judgment.”

    Key recommendations in the Nanotechnology Task Force Report centered on regulatory and scientific issues. Scientific issues related to the interactions of nanoscale materials with biological systems and the adequacy of testing approaches for assessing safety and the quality of products containing nanoscale materials. Recommendations in both areas focus on the FDA promoting and participating in the development of better science to permit more informed decision-making.

    Interestingly, the Task Force went to great lengths in clarifying the FDA’s regulatory authority. In doing so, it acknowledged the FDA’s lack of pre-market authority over cosmetics and dietary supplements. Recommendations were not made to seek such authority but instead sought to provide additional guidance to manufacturers on safety issues to be considered in creation of these products.

    The Task Force rejected recommendations for labeling of products containing nanoscale materials because “the current science does not support a finding that classes of products with nanoscale materials necessarily present greater safety concerns than classes of products without nanoscale materials.”
  • The long-awaited voluntary program took center stage this week and there was no shortage of opinions on the EPA’s proposal to gather additional information on the safety of nanoscale materials.

    While there was broad acceptance of the Nanoscale Materials Stewardship Program (NMSP) by industry, others took exception to the program as too little, too late. J. Clarence Davies, Former EPA Assistant Administrator for Policy and Senior Advisor to the Woodrow Wilson Center for International Scholars’ Project on Emerging Nanotechnologies, strongly criticized the agency’s actions the day the public meeting was announced.

    According to Davies, “The agency’s current practice is inadequate to deal with nanotechnology. It is essential that EPA move quickly to recognize the novel biological and ecological characteristics of nanoscale materials. It can do this only by using the ‘new uses’ provisions of TSCA, a subject not mentioned in the EPA’s inventory document. With the approach outlined by EPA and because of the weaknesses in the law, the agency is not even able to identify which substances are nanomaterials, much less determine whether they pose a hazard.”

    Also strongly objecting to the voluntary program is Environmental Defense. In a statement made by Senior Scientist Richard Denison, the EPA was criticized for “resetting the clock,” making reference to recommendations made by the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) nearly two years ago. NPPTAC, a federal advisory committee, supported the voluntary program at the time if it also included a “backstop” regulatory effort to develop “appropriate Toxic Substances Control Act Section 8(a) and 8(d) rules.”

    Environmental Defense and two other non-governmental organizations participated in those discussions but resigned citing concerns over resistance to changes by EPA in assessing and managing chemicals under the TSCA. Citing an imbalance of industry membership in the group, resigning members were dissatisfied with the nature and extent of issues addressed.

    The EPA was also taken to task for the lack of any deadlines in the program for companies to sign up, submit information to the EPA or apply risk management practices. The other key area of concern expressed at the public meeting was the agency’s failure to use Significant New Use Rules (SNURs) to gather additional information on the safety of nanoscale materials already in the marketplace.

    Not all of the comments expressed at the public meeting were negative. Dr. Shaun Clancy of the American Chemistry Council’s Nanotechnology Panel, Jim Cooper of the Synthetic Organic Chemical Manufacturers Association and Sean Murdock of the NanoBusiness Alliance all supported the EPA’s approach and strongly encouraged companies engaged in the production or use of nanoscale materials to support the program by participating to the greatest extent possible.

    Comments on the proposed program will be accepted up to September 10, 2007 and the EPA expects to provide a Federal Register notice shortly to announce a public meeting on September 6th and 7th to address the characterization of nanoscale materials.
  • Quantum dots have gained favor as an improved method of imaging cells in biomedical applications. There’s only one problem – they can be toxic.

    Gelatin was employed as a co-capping agent in experiments to finds ways to reduce the inherent toxicity of quantum dots. Researchers at the University of Dublin recently published the results of their work, ”Jelly Dots”: Synthesis and Cytotoxicity Studies of CdTe Quantum Dot-Gelatin Nanocomposites, in Small, an interdisciplinary journal that publishes research in science and technology on the micro- and nanoscales.

    Quantum dots have been recently used to study cell processes at the level of a single molecule. The nanoscale material has played a role in the diagnosis and treatment of cancers and the use of fluorescent quantum dots has led to significant advancements in high-resolution cellular imaging.

    The results of the study reinforce previous findings that quantum dot toxicity is directly related to the functionality of the core and surface properties.
  • In a previous cytotoxicity study of fullerenes, adverse effects were found in several different types of human cells but, in a new in vivo rat study, fullerenes seemed to show little effect on pulmonary toxicity.

    Underivatized C60 and a highly water-soluble derivative, C60(OH)24 were instilled intratracheally to examine the pulmonary toxicity effects and compare the results to previous in vitro studies. The results showed “little or no difference in lung toxicity effects when compared to controls.”

    The researchers, David Warheit and Christie Sayes were part of a team from the DuPont Haskell Laboratory for Health and Environmental Sciences and the DuPont Corporate Center for Analytical Services conducting the study.

    The study, Comparative Pulmonary Toxicity Assessments of C60 Water Suspensions in Rats: Few Differences in Fullerene Toxicity in Vivo in Contrast to in Vitro Profiles, was recently published in the American Chemical Society’s Nano Letters.
  • The toxicity of nanoscale materials may not yet be well understood but the potential risks are getting a lot of attention.

    The International Risk Governance Council’s (IRGC) White Paper on Nanotechnology Risk Governance was the focus of a recent conference hosted by Swiss Re at its Centre for Global Dialogue. The White Paper provides recommendations on a framework “to analyse and identify current deficits in nanotechnology’s risk governance.”

    Recommendations are viewed in the context of applications currently, or about to be, in the marketplace (Frame 1) and applications still in development (Frame 2). Frame 1 uses conventional risk assessment techniques to evaluate their applicability to nanoscale materials and Frame 2 focuses on the type of data and other information needed to improve risk assessment techniques and better evaluate risks with fewer unknowns and uncertainties.

    The International Risk Governance Council (IRGC) is an independent, private foundation established under the Swiss Civil Code. IRGC’s purpose is to help the understanding and treatment of emerging global risks that may impact on human health and safety, the environment, the economy and society at large.

    Stakeholders at the Swiss Re conference, The Risk Governance of Nanotechnology: Recommendations for Managing a Global Issue, provided many recommendations on risk governance including a specific endorsement of voluntary programs for the collection of hazard data to better inform government regulators.

    The White Paper was primarily authored by Dr. Mihail Roco and the U.S. Environmental Protection Agency provided financial support for the project. Dr. Roco is on the National Science and Technology’s subcommittee on Nanoscale Science Engineering and Technology and is also Senior Advisor for Nanotechnology at the National Science Foundation.
  • On June 1, 2007 the new Registration, Evaluation and Authorisation of Chemicals (REACH) went into effect but the impact it has on the regulation of nanoscale materials remains unclear.

    A recent workshop held by the Nanotechnology Industries Association (NIA) posed the question of nanomaterial regulation as part of a workshop designed to clarify the status of these chemical substances under the new regulations.

    The main conclusions of participants about REACH appear to be similar to the EPA’s stance on the regulation of nanomaterials. Citing the lack of specific regulations for nanomaterials, each substance will be evaluated on a case-by-case basis. However, REACH officials concede the possibility of creating specific categories and corresponding requirements for nanomaterials in the future.

    The NIA, based in Cambridge, U.K., was formed in 2005 by a group of companies from a variety of industry sectors including healthcare, chemicals, automotive and consumer products.
  • Environmental Protection Agency (EPA) officials have been talking about the Nanoscale Material Stewardship Program (NMSP) for almost two years and the announcement finally came. Now the real work begins.

    The EPA finally made it official and the naysayers started chiming in before most had a chance to review the background material provided in advance of a public meeting to be held on August 2nd. J. Clarence Davies, Woodrow Wilson Center’s Project on Emerging Nanotechnologies senior advisor, released a statement critical of EPA’s current approach to nanoscale materials.

    According to Davies, the key negative aspect of the proposed NMSP is the lack of attention to the “new uses” of nanoscale materials.

    In a Concept Paper for the Nanoscale Materials Stewardship Program under Toxic Substances Control Act, the agency outlines the program by describing potential program participants, the type of information to be reported as part of the program, the type of data which may need to be developed and how the EPA intends to use the data.

    While the key component of the basic program calls for manufacturers and processors to provide existing data and information on existing nanoscale materials, the EPA is also requesting information on risk management practices currently in use or under development. Information provided in the basic program could also lead to the development of new data in the in-depth program to “better characterize hazard, risk and exposure issues” for each material.

    In an accompanying document, TSCA Inventory Status of Nanoscale Substances – General Approach, the EPA provides background information on how it conducts evaluations of chemical substances to determine if they are “new” or “existing.” The document also provides examples of materials appropriate for inclusion in the Nanoscale Materials Stewardship Program (fullerenes, nanotubes, polymeric dendrimers and nanoscale metal and metal oxides) and materials that would not be included (polymers, heavy fuel oils, organic dyes and biological materials).

    The agency makes it abundantly clear that the NMSP is intended to address only materials regulated under the Toxic Substances Control Act (TSCA). Specifically omitted are any pesticides covered exclusively by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). This is a curious omission in light of the current debate about nanoscale silver as an antimicrobial.

    The NMSP also excludes materials regulated by the Food and Drug Administration such as food additives, pharmaceuticals, medical devices and cosmetics.

    While it’s difficult to say at this point that the EPA missed an opportunity for a better voluntary program, the documents do provide insight to the agency’s thought processes about the regulation of nanoscale materials.

    The public meeting is the first of three currently planned by the EPA. After the public meeting to discuss the Nanoscale Materials Stewardship Program, there will be a Pollution Prevention through Nanotechnology conference on September 25th and 26th. This will be followed in the fall of 2007 with a “scientific peer consultation regarding material characterization as it relates to nanoscale material.”
  • The applications and implications of nanotechnology for health, safety and the environment were the focus of a recent meeting of the President’s Council of Advisors on Science and Technology (PCAST).

    The morning session of the meeting was highlighted by five experts who addressed nanotechnology applications. Michael Holman (Lux Research), Jim von Ehr (Zyvex), William Moffitt (Nanosphere), Lubab Sheet (SEMI) and Stephen Maebius (Foley & Lardner) discussed competition, intellectual property and business issues confronting companies in the nanotech industry.

    Dr. Sally Tinkle (National Institute of Environmental Health Sciences), Dr. Gunter Oberdorster (University of Rochester), Dr. Andrew Maynard (Woodrow Wilson International Center for Scholars, Project on Emerging Technologies), Matthew Hull (Luna Innovations) and Dr. Michele Ostraat (DuPont) spoke in the afternoon session. Presentations centered on environmental and human health research priorities, product stewardship, health surveillance and environmental management.

    Experts in attendance agreed that much more work needs to be accomplished to characterize nanoscale materials and to prepare for the safety implications of the next generation of nanomaterials.
  • Quantum dots have been showcased as an example of nanotechnology benefiting biomedical imaging applications but they remain in the body much longer than expected.

    The study, Persistent Tissue Kinetics and Redistribution of Nanoparticles, Quantum Dot 705, in Mice: ICP-MS Quantitative Assessment, was recently published in the National Institute of Environmental Health Sciences’ Environmental Health Perspectives.

    Mice were given an intravenous injection of QD705 and quantitative measurements show the nanoscale material was taken up by several body organs for 28 days.

    The quantum dots remained in the bodies of the mice and were not excreted in the urine or feces in any detectable amounts after 28 days. Researchers showed a considerable time-dependent redistribution from body mass to the liver, kidney and spleen over that time.

    The key conclusion of the study authors is that QD705 has a very long half-life, potentially weeks or months, in the body and its health consequences “deserve serious consideration.”
  • With a long-running controversy about the amount of money spent by the federal government on nanotechnology safety research, the Environmental Protection Agency is making sure the public learns about every newly-funded research project.

    Two grants totaling nearly $600,000 have been awarded to Oregon State University (OSU) to evaluate whether some engineered nanoscale materials could be toxic to human health.

    The first OSU grant award of $400,000 for A Rapid In Vivo System for Determining Toxicity of Manufactured Nanomaterials, will screen a wide range of commonly manufactured nanomaterials to determine their potential interactions with biological processes. If the OSU research team, led by Dr. Robert Tanguay, finds nanomaterials that produce adverse effects, they will identify the potential cellular and genetic targets of these nanomaterials and group the particles by composition and effects.

    "We believe it is critical to couple the development of novel nanomaterials with the assessment of their effects on biology so society can get the maximum benefit from the nanotechnology revolution," said Tanguay.

    The second OSU grant award of $199,993 for a Genomics-based Determination pf Nanoparticle Toxicity: Structure-function Analysis, will determine how manmade nanomaterials could damage or kill cells. Dr. Alan Bakalinsky is studying the relationship between specific characteristics of nanoparticles, like shape and structure, and their effects on cells. The work is expected to lead to the development of safety guidelines for industrial and environmental exposure to nanomaterials.

    "We're trying to identify specific structures in manufactured nanoparticles that might cause damage to cells," said Bakalinsky. "If we can determine which shapes and structures are most dangerous to cell function, it should be possible to design the materials to avoid those shapes and minimize the risk of damage."

    The Environmental Protection Agency’s National Center for Environmental Research web site contains a full listing of nanotechnology research grants.
  • Many have been critical of the lack of government regulatory action on nanomaterials in the United States but a recent Swiss report provides a rationale for the perceived government inaction.

    The basic conclusion of the report, Risk Assessment and Risk Management for Synthetic Nanomaterials 2006-2009, indicates that “there is not yet sufficient basic information of a scientific or methodological nature for a conclusive risk assessment of nanoparticles to be carried out, or to be regulated.”

    The report notes that little research has been done on the potential risks that nanoparticles present for human health. In addition, the report accurately points out that “there is still a lack of uniform test methods and the basic scientific knowledge to carry out a comprehensive characterization of nanomaterials.”

    U.S. officials have grappled with many of the same issues in trying to establish a regulatory agenda for nanoscale materials. Non-governmental organizations and industry have privately complained about the length of time the Environmental Protection Agency is taking even to release any information in advance of its proposed voluntary program to collect information on nanoscale materials.

    Prepared by the Federal Office for the Environment and the Swiss Federal Office of Public Health, the report shows how difficult it is to gain enough scientific knowledge to update chemical production and use regulations for nanoscale materials.
  • The European Commission has launched a public consultation on whether current EU risk assessment methodologies are appropriate for evaluating the risks associated with nanomaterials in cosmetic products.

    Stakeholders are invited to give their views on a preliminary opinion issued by the Scientific Committee on Consumer Products (SCCP). It says that traditional risk assessment methods, such as hazard identification and characterization, may not be suitable for some nanomaterials in make-up and other cosmetic products.

    Nanomaterials can be divided into two groups: labile particles, which disintegrate when applied to the skin, or insoluble particles. For the labile group, the SCCP suggests that conventional risk assessment methodologies based on mass metrics may be adequate.

    However, for insoluble particles, other metrics, such as the number of particles and their surface areas, as well as their distribution, would need to be assessed. The health risks associated with insoluble particles are of particular concern, says the Committee, because repeated application could lead to their accumulation in other parts of the body, such as the lungs.

    The opinion offers two alternatives: either a new method should be developed, or the existing methodologies for hazard characterization and exposure assessment should be validated. The SCCP also considers that nanomaterials, when used in the cosmetics industry, should be assessed on a case-by-case basis, taking into account their specific physical, chemical and surface characteristics.

    The SCCP published initial findings in its Preliminary Opinion on Safety of Nanomaterials in Cosmetic Products.

    The public consultation closes on September 6, 2007 and comments may be submitted here.
  • Now there is a framework with six simple steps for any organization to evaluate and manage the potential risks posed by nanoscale materials.

    Environmental Defense and DuPont released a comprehensive framework to assist with the responsible development and use of nanotechnology and to help inform the global dialogue on its potential risks. Intended for use by small and large companies, regulatory agencies, universities, and others, the Nano Risk Framework was initially developed by Environmental Defense and DuPont and later revised to incorporate comments from over 40 organizations, government officials, academics and individuals.

    The Framework offers a six-step process for organizations to identify, assess and manage potential risks. The six steps within the Framework include: describing the material and the intended application; profiling the material's lifecycle in this application; evaluating the associated risks; assessing risk management options; deciding and documenting actions; and regularly reviewing new information and adapting actions accordingly.

    "This Framework outlines a disciplined process for the responsible development of nanomaterials," said DuPont Vice President and Chief Sustainability Officer Linda Fisher. "At DuPont, we have adopted this approach as a part of our mandatory product stewardship process, and we encourage others to do the same. While we do not see this Framework as a substitute for regulation, we hope that it assists governments in drafting appropriate regulations."

    To illustrate the effectiveness, flexibility and practicality of the framework, DuPont conducted three demonstration projects on three different classes of nanoscale materials: a new titanium dioxide-based product, carbon nanotubes and zero-valent iron.

    "These projects were selected not only because they are of interest to DuPont, but also because they represent a good test of the Framework," DuPont Global Regulatory Affairs Director Terry Medley said. "Each represents a different position for DuPont in the value chain and is at a different stage of development. The projects required different resources, produced varying outcomes, and each demonstrated different aspects of the Framework."
  • Another source of information has become available which summarizes data available on the potential health effects of nanomaterials.

    The United Kingdom’s Health and Safety Executive NanoAlert Service recently released its first bulletin providing an overview of evidence in peer-reviewed scientific papers in two specific areas: 1) Measurement, characterization and control of exposure to nanoparticles; and 2) The potential for toxic effects of nanoparticles in humans.

    The first bulletin summarizes literature published from 2000 to 2006. Subsequent bulletins will cover the previous four-month period.

    A wide variety of databases were searched using specific combinations of terms developed to identify studies most relevant to nanotechnology. The initial search returned almost 47,000 hits but refinement of the search terms produced approximately 1,300 hits in the area of measurement, characterization and contol of exposure as well as over 500 hits for the potential toxic effects of nanoparticles for humans.

    Abstracts for all of the references identified were screened and the bulletin provides an overview of all of the relevant references with more detailed summaries of the key studies.

    The area of measurement, exposure and control, provided the greatest source of information with 91 papers on the use of instruments to assess exposure of airborne ultrafine particles (for pollution). In the area of human health effects over 80 papers on animal in vivo studies and over 50 human studies were identified.
  • In an effort which has received very little publicity, the international effort to inform and guide regulatory policy for nanoscale materials is quietly moving forward.

    In a recent public appearance, the Environmental Protection Agency’s Jim Willis, provided insight on the current activities of the Organization for Economic Co-operation and Development’s (OECD) Working Party on Manufactured Nanomaterials (WPMN). The WPMN is part of the OECD Council’s Chemicals Committee which is tasked with the promotion of international co-operation on the human health and environmental safety of manufactured nanomaterials, and is involved with approaches to the safety testing and risk assessment of manufactured nanomaterials.

    WPMN activities are being implemented through six specific projects: Development of an OECD Database on Human Health and Environmental Safety (EHS) Research; Human Health and Environmental Safety Research Strategies on Manufactured Nanomaterials; Safety Testing of a Representative Set of Manufactured Nanomaterials; Manufactured Nanomaterials and Test Guidelines; Co-operation on Voluntary Schemes and Regulatory Programmes; and Co-operation on Risk Assessment and Exposure Measurements.

    Each project is being moved forward through a steering group, which include a lead country/Chair along with a number of other volunteer delegations. The current Chair of the WPMN is the United States with Australia, Canada, Germany, Japan, United Kingdom and the European Commission are Vice-Chairs.
  • The Environmental Protection Agency (EPA) is finally setting the wheels in motion for the Nanoscale Materials Stewardship Program.

    On September 25-27, 2007, the Environmental Protection Agency will hold a Pollution Prevention Through Nanotechnology Conference in Arlington, Virginia “to exchange ideas and information on using nanotechnology to develop new ways to prevent pollution.”

    The conference is one of a series of activities planned by the EPA to better understand nanoscale materials and to encourage the development of pollution prevention processes and products through the use of nanotechnology.

    Other activities planned for the Stewardship Program include a public meeting to discuss the program and a scientific peer consultation on nanoscale material characterization. EPA officials have indicated that several documents related to the Stewardship Program will be released in the summer of 2007 and the documents will be discussed at a public meeting.

    Conference participants are asked to consider three questions: 1) Which nanotechnologies show the greatest promise for preventing pollution?; 2) What are the most promising areas of research on pollution prevention applications of nanotechnologies?; and 3) What recommendations do conference participants have for promoting and encouraging pollution prevention in the development and application of nanotechnology?

    A poster session is planned and applications are due July 31st. There is no charge to attend the conference but registrations must by received by September 14, 2007.
  • Nanoscale silver has shown great promise as an antimicrobial and government officials have joined the rising chorus of voices recommending additional study of the potential risks of the material.

    Nominated for study by the National Toxicology Program (NTP) by the Food and Drug Administration (FDA), nanoscale silver has been increasingly used in drugs, food and cosmetic products. According to the Woodrow Wilson International Center for Scholars there are 93 consumer products available using nanoscale silver. Wound dressings, textiles and dietary supplements are incorporating the material into products and the FDA nomination cited a general lack of data on the toxicology and pharmacokinetics of the chemical substance.

    The aim of the study is to: Characterize the relationship between nanoscale silver particle size and degree of ionization to silver; Evaluate the effect of particle size and ionization state on the pharmacokinetic profile of nanoscale silver; and Evaluate the effect of particle size and ionization state on the toxicological profile of nanoscale silver in vivo.

    In recent months the Environmental Protection Agency has reversed its policy on nanoscale silver and is taking a second look at the Samsung washing machine as an antimicrobial rather than a device.

    In addition to nanoscale silver, the NTP is also conducting studies on quantum dots, fullerenes, carbon nanotubes, titanium dioxide, cerium oxide, dendrimers and colloidal gold.
  • Researchers at the University of Virginia School of Medicine have created a new online search engine that provides medical professionals, researchers and the general public with a more efficient and targeted way to search PubMed for medical news related to nanotechnology.

    Designed to retrieve the most relevant recent references published about a problem or a combination of medical conditions, Relemed can provide targeted information on published articles about the risks of nanoparticles in addition to health issues associated with the generation and use of nanoscale materials.

    The database specializes in researching information on search terms and their relationship to one another rather than simply providing the most recent published articles containing search terms. Using nanotechnology as a single search term provides over 1,000 relevant articles.
  • With no single set of regulations governing nanotechnology products, a new study of European regulations concludes that more information is needed and the current regulatory framework should be revised.

    The report, Nanomaterials in Consumer Products, was prepared for the European Parliament’s Committee on the Environment, Public Health and Food Safety by the National Institute for Public Health and the Environment and the Wageningen Centre for Bionanotechnology for Food and Health Innovations.

    The objective of the study is to “provide an analysis and an assessment of the adequact of the current regulatory framework to address the risks to human health and the environment due to the use of consumer products containing nanoparticles.” The analysis addressed three key issues: 1) An inventory of consumer products containing engineered nanoparticles; 2) Adequacy of the existing regulatory framework to address risks posed by nanoscale materials; and 3) Suggestions for changes to existing regulations.

    Study authors provided six options for adapting the current regulatory framework. Since REACH does not specifically address nanoscale materials, it was suggested that all nanomaterials could be considered new substances with establishment of lower quantity thresholds since the amount of material produced is on a much smaller scale than traditional chemical substances. A related option would allow REACH to consider nanoscale materials as “substance variants” of the bulk form of an existing product.

    Also suggested is a separate nano regulation or, at a minimum, new nano-specific data requirements under REACH. The final suggestion calls for labeling of products containing nanoscale materials to allow consumers to make informed decisions about the products they purchase.
  • Stakeholders had an opportunity to discuss the basic elements of an approach for the Canadian government to take on the regulation of nanotechnology and by the time they were done, a dozen key elements were defined.

    The Canadian Institute for Environmental Law and Policy (CIELAP) convened a multi-stakeholder workshop in Toronto last March to explore policy considerations for nanotechnology. The result of the workshop was recently released in a Discussion Paper on a Policy Framework for Nanotechnology authored by Senior Policy Analyst Susan Holtz.

    The workshop was co-sponsored by the Ontario Genomics Institute, contracted by Health Canada and additional funding was provided by Canadian Biotechnology Strategy.

    In the discussion paper, CIELAP supports a policy “that is centered on an explicit recognition and endorsement of sustainable development.” The report indicated there was a sense of urgency for Canadian officials to take action due to the lack of available scientific information and the rapid development and deployment of nano-enhanced products.

    The following are twelve key elements that CIELAP believes must be addressed in any Canadian policy framework for nanotechnology: (1) Basic societal goals; (2) Public education and engagement; (3) An inventory of activities and information sources; (4) Lead agencies; (5) Technical issues such as terminology and metrology; (6) Regulatory approach, including science, risk assessment, and stakeholder involvement; (7) Labeling and consumer protection; (8) Liability and intellectual property regimes; (9) Science and research support; (10) Commercialization and social and economic benefits; (11) Training; and (12) Security concerns.

    CIELAP, based in Toronto, Ontario, is an independent, not-for-profit professional research and educational institute committed to environmental law and policy analysis and reform.
  • NanoComp Technologies is on the cusp of a textile revolution with the development of carbon nanotube yarn and non-woven sheets but it pays attention to the potential risks of working with nanoscale materials.

    NanoComp has successfully developed next-generation performance materials using only carbon nanotubes. The new material has shown potential as body armor for the military as well as stronger, lighter composites with a variety of applications from defense to automotive applications.

    The company’s President, CEO and founder, Peter Antoinette, tells the NanoReg Report “We want to stay ahead of the curve” when it comes to protecting its workers. Interviewed at the recent Nanotech 2007 Conference, Mr. Antoinette also said he “prefers to be proactive” when it comes to safety.

    NanoComp worked with professors from the UMass Lowell nanotechnology manufacturing research center to conduct high precision, high sensitivity background testing in several areas of the facility including offices and manufacturing areas. Extensive efforts have gone into engineering controls such as environmental containment, use of a Class 10 clean room and employing the use of personal protective equipment when appropriate.

    As with many companies producing and using nanoscale materials, concern was expressed about the lack of viable methods for testing the toxicity of nanomaterials. Without such tests, hazards are difficult to characterize so safety efforts tend to focus on the reduction or elimination of exposure to nanomaterials.

    NanoComp currently employs 14 people and is based in Concord, New Hampshire.
  • Nano makes everything better, right? Not according to recent report on testing of sunscreens by Consumer Reports.

    In one of the first side-by-side comparisons done on nano-enhanced products, results of tests on sunscreens is highlighted in the July 2007 issue of the well-known consumer magazine along with a full-length article on the potential dangers associated with nano-enhanced products.

    Nineteen sunscreen products were tested by Consumer Reports at outside laboratories. Eight of the products listed zinc oxide or titanium dioxide on the label, which could indicate the presence of nanoparticles. A test of those eight sunscreens found that all contained nanoparticles, but only one disclosed the presence of nano-zinc oxide.

    Surprisingly, the tests revealed no correlation between the effectiveness of sunscreen protection and the presence of nanoparticles.

    With nanotechnology cast as an “unknown promise” with an “unknown risk,” consumers are told there is cause for concern based on the findings of publicly available research on nanoscale materials.

    Ultimately, recommendations made in the article are those many could agree with: Improvement of Food and Drug Administration (FDA) oversight on the safety of cosmetics; Provision of additional research funding for the FDA, National Institute for Occupational Safety and Health (NIOSH), Environmental Protection Agency (EPA), and the Consumer Product Safety Commission (CPSC); and Consideration of new safety legislation.

    Perhaps the most controversial suggestion is the recommendation to make labeling of all products regulated by the FDA mandatory. Despite resistance to the recommendation by many producers due to the presumption of risk, Consumer Reports takes the concept one step further by suggesting the Federal Trade Commission “consider charging companies with false or misleading advertising if their marketing fails to disclose the presence of nanomaterials.”
  • In a review of data on potential harmful effects on the environment and human health, researchers have determined that not all carbon nanotubes are created equal.

    The research, recently published by the National Institute of Environmental Health Sciences’ Environmental Health Perspectives, examined over 50 toxicological studies on single- and multi-walled carbon nanotubes. The bulk of the studies are in vitro studies and researchers acknowledged that little information is available on the environmental effects of these nanoscale materials.

    One key conclusion of authors of the study, Reviewing the Environmental and Human Health Knowledge Base of Carbon Nanotubes, is that “There are different types of carbon nanotubes and therefore they cannot be considered a uniform group of substances.” This finding alone will make it very difficult for government regulators to look at carbon nanotubes as a single substance.

    Several of the studies reviewed showed that carbon nanotubes can be bioavailable to organisms, may be “highly persistent,” and may accumulate along the food chain.

    Another key finding of note is that the toxicity of carbon nanotubes used in several studies was dependent on the material’s physical and chemical characteristics “which are influenced by the external environmental conditions during the carbon nanotube production, usage and disposal stages.”

    Authors recommend standardization of carbon nanotube material for testing, development of standard testing protocols and including life cycle assessments to fully evaluate the toxicity of carbon nanotubes as an appropriate course of action to establish the safe production, use and disposal of these materials.
  • The growing depth of knowledge on nanoscale materials has increased with the addition of another database of information for technical professionals and the general public.

    The free NanoEthicsBank database has been made available by the Center for the Study of Ethics in the Professions at the Illinois Institute of Technology. Although toxicological studies are not part of the database, reviews, public reactions and media reports of such studies will be included.

    Major subject categories in the database include information on the development of best industry practices and voluntary standards by industry using nanoparticles, the ethical development of nanotechnology and national and international initiatives being undertaken in the construction of a regulatory framework.

    The NanoEthicsBank is part of the NanoConnection to Society project which is funded by the National Nanotechnology Initiative and the National Science Foundation.
  • The Environmental Protection Agency should change its regulations and not wait for the upcoming voluntary program to collect information on the safety of nanoscale materials according to a new study released last week.

    The study, EPA and Nanotechnology: Oversight for the 21st Century, was authored by J. Clarence (Terry) Davies, a senior advisor to the Project on Emerging Technologies at the Woodrow Wilson I