Policy News for the Nanotechnology Value Chain
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  • 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

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    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 Peñoles 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 Nan