Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

The U.S. Environmental Protection Agency (EPA) published on February 3, 2010, a proposed significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for multi-walled carbon nanotubes. The proposed rule would require persons who intend to manufacture, import, or process the substance for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. EPA states that the required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due March 5, 2010.

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On January 8, 2010, the United Kingdom (UK) House of Lords Science and Technology Committee announced the availability of its report entitled Nanotechnologies and Food, which criticizes the food industry for failing to be transparent about its research into the uses of nanotechnologies and nanomaterials. In its report, the Committee urges the Government and Research Councils to fund research into potential health and safety risks arising from the use of nanomaterials in the food sector. The Committee recommends that the Food Standards Agency maintain a publicly available register of food and food packaging containing nanomaterials, and suggests that the register be made available online. The Committee calls for nanomaterials to be defined clearly in food legislation to ensure that all uses of nanomaterials in food are subject to appropriate risk assessment procedures. According to the Committee, regulatory definitions should use a change in functionality, i.e. how a substance interacts with the body, as the criterion that distinguishes a nanomaterial from its larger form, to ensure that any nano-sized materials with novel properties are included. The Committee also recommends that the UK work with other European Union (EU) nations to clarify what is meant by the phrase “properties that are characteristic to the nanoscale” in the draft definition proposed for the revised Novel Foods Regulation, by the inclusion in legislation of a more detailed list of what these properties comprise. The Committee also raises concerns about the potential for the illegal importation of food products containing nanomaterials not approved for use in food in the EU.

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On January 8, 2010, the U.S. Environmental Protection Agency (EPA) extended until February 8, 2010, the comment period for its November 6, 2009, proposed significant new use rules (SNUR) for multi-walled carbon nanotubes (CNT) and single-walled CNTs.  According to the January 8, 2010, notice, EPA received a request to extend the comment period.  On December 1, 2009, the U.S. World Trade Organization (WTO) Technical Barriers to Trade (TBT) Inquiry Point at the National Institute of Standards and Technology (NIST), on behalf of the European Economic Community (EEC) WTO TBT Enquiry Point, submitted a request to extend the comment period. According to the request, “the European Communities are currently reviewing the draft regulation,” and request that the comment deadline be extended. According to Charles Auer, formerly the Director of EPA’s Office of Pollution Prevention and Toxics (OPPT) and now affiliated with Bergeson & Campbell, P.C., this is the first request he is aware of from the EEC TBT Enquiry Point to OPPT. Auer noted that the EEC is not necessarily raising a trade concern, but may simply want to know the scope of the proposed regulation.

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In a December 16, 2009, letter, three members of the Wisconsin Assembly requested that a Legislative Council study be conducted on the feasibility of creating a nanotechnology registry and the development of subsequent legislation to monitor the use, manufacture, and disposal of nanomaterials in Wisconsin. The letter, signed by State Representatives Terese Berceau (D), Chuck Benedict (D), and Penny Bernard Schaber (D), notes that entities manufacturing or using nanomaterials in Wisconsin are not required by state or federal regulation to identify materials they are using, how they transport and dispose of them, or where such work is taking place. According to the letter, data gaps present “serious concerns” to first responders and public agencies responsible for addressing health consequences or releases into air or water. The letter states: “The development of a registry in partnership with science, business, and the public sector -- and which enhances the economic development of our state -- is our ultimate goal.”

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The Silver Nanotechnology Working Group (SNWG) issued a press release regarding its presentation to the U.S. Environmental Protection Agency’s (EPA) Scientific Advisory Panel (SAP) at its November 3-6, 2009, meeting. EPA asked the SAP “to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.” According to EPA, companies with an interest in marketing products that contain nanosilver and/or other nanometals or nanometal oxides as pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) have approached the Office of Pesticide Programs (OPP) seeking product registration. SNWG’s analysis included the key conclusions that nanosilver is not a new material and that EPA has “safely and successfully” regulated nanosilver products for decades.

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On November 13, 2009, the National Institute for Occupational Safety and Health (NIOSH) released two nanotechnology publications. NOISH posted a document entitled Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center, Project Updates for 2007 and 2008. The Report updates the February 2007 version, which described the progress of the NIOSH Nanotechnology Research Center (NTRC) since its inception in 2004 through 2006. In the November 2009 Report, NIOSH describes program accomplishments achieved in 2007 and 2008. NIOSH states that the NTRC has, with limited resources, continued to make contributions to all the steps in the continuum from hazard identification to risk management. The second document, entitled 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 as described in the 2007 report Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center and the 2009 update. NIOSH states that the Strategic Plan for the nanotechnology program is the roadmap it is using to advance knowledge about the implications and applications of nanomaterials.

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On November 11, 2009, the European Commission (EC) began a public consultation to receive input from all people and organizations involved or interested in nanosciences and nanotechnologies research in Europe, including researchers, policy makers, industry, media, and civil society organizations. The EC adopted on February 7, 2008, a Recommendation for a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research, followed on September 26, 2008, by Council Conclusions on Responsible Nanosciences and Nanotechnologies. Both documents suggested that the EC Recommendation and Code of Conduct should be revised after two years. The EC intends to make these revisions in February 2010, and states that the results of the consultation will contribute to that. The Code of Conduct is intended to frame future research development within a set of general principles on which member states are invited to take concrete action to ensure that nanotechnologies are developed in a safe manner. The online consultation ends on January 3, 2010.

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On November 9, 2009, Australia announced the availability of a public discussion paper proposing to strengthen regulation of industrial nanomaterials used in Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) developed the proposal in conjunction with its Nanotechnology Advisory Group, which includes representatives from industry, the community, and research sectors. Major regulatory reforms would include:  refinement of pre-market assessment categories for nanoforms of new chemicals, particularly where human health or environmental exposure can reasonably be anticipated; and a mandatory notification and assessment program for nanoforms of existing chemicals. The discussion paper contains a questionnaire and survey intended to encourage written submissions. Comments are due December 23, 2009.

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On October 29, 2009, the European Commission (EC) adopted a Communication entitled Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009. Second Implementation Report 2007-2009. The Communication outlines the key developments during 2007-2009 in each policy area of the Nanotechnology Action Plan 2005-2009, identifies current challenges, and draws conclusions relevant to the future European nanotechnology policy. According to the Communication, the EC has made significant progress on all points in the Action Plan. The Communication notes that, “[a]s a general remark, the past two years have seen a substantial development of nanotechnology, supported by a further growth in research funding and the active development of policy. . . . In view of this, efforts to address societal and safety concerns must be continued to ensure the safe and sustainable development of nanotechnology.” The Communication states that the EC “is considering proposing a new Nanotechnology Action Plan that would be one of the driving forces of the European Research Area and address important societal and environmental issues.”

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On November 6, 2009, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two chemical substances that were the subject of premanufacture notices (PMN). EPA identified the substances generically as multi-walled carbon nanotubes and single-walled carbon nanotubes. According to the notice, these substances are subject to TSCA Section 5(e) consent orders issued by EPA. The consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs are based on and consistent with the provisions in the underlying consent orders, and designate as a significant new use the absence of the protective measures required in the corresponding consent orders. Persons who intend to manufacture, import, or process either of these two substances for an activity that is designated as a significant new use would be required by the proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due December 7, 2009.

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The U.S. Environmental Protection Agency (EPA) has announced that it will stream its November 3-6, 2009, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting on the Internet. EPA has asked the SAP “to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.” According to EPA, companies with an interest in marketing products that contain nanosilver and/or other nanometals or nanometal oxides as pesticides regulated under FIFRA have approached the Office of Pesticide Programs (OPP) seeking product registration. OPP believes, based on its understanding of the scientific literature, that pesticides containing nanoscale materials may pose different risks to humans and the environment than those of pesticides that do not contain nanomaterials.

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In an October 9, 2009, speech at the stakeholder conference concerning nanomaterials on the market, Stavros Dimas, European Commissioner for the Environment, stated that the European Commission (EC) “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.” The EC’s review is in response to an April 24, 2009, resolution adopted by the European Parliament that questions whether current legislation covers the relevant risks relating to nanomaterials and asks the EC to consider whether revisions are necessary to address nanomaterials.  Dimas stated that the EC “has not made up its mind on how precisely to get the information needed.” The EC intends to look at measures taken by member states and non-European Union (EU) countries, including voluntary reporting programs.

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On September 30, 2009, the U.S. Environmental Protection Agency (EPA) announced the availability of the Nanomaterial Research Strategy (Strategy), which EPA describes as its new research strategy to understand better how manufactured nanomaterials may harm human health and the environment.  The Strategy outlines what research EPA intends to support over the next several years to generate information about the safe use of nanotechnology and products that contain nanoscale materials.  The Strategy also includes research into ways nanotechnology can be used to clean up toxic chemicals in the environment.  In its announcement, EPA states that its role among federal agencies “is to determine the potential hazards of nanotechnology and develop approaches to reduce or minimize any risks identified.  As part of the strategy, researchers are investigating widely used nanomaterials, such as carbon nanotubes, which are used in vehicles, sports equipment and electronics; and titanium dioxide, which is used in paints, cosmetics and sunscreens.”

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On September 23, 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Technologies (PEN) hosted a meeting on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies.” The program is part of a collaborative research project involving experts from the London School of Economics (LSE), Chatham House, the Environmental Law Institute (ELI), and PEN. The project is funded by a grant from the European Commission to support pilot projects on “Transatlantic methods for handling global challenges.” The purpose of yesterday’s meeting was to discuss recommendations from the research effort that are part of a report released on September 10, 2009. The meeting was also intended to generate and examine new ideas to enable greater transatlantic convergence on nanotechnology oversight today and in the future.

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 The California Department of Toxic Substances Control (DTSC) announced it will host the DTSC/California Nano-Industry Network Symposium, to be held November 16, 2009, in Sacramento, California. The Symposium, which is co-sponsored by the American Chemistry Council and Dupont, will use the DTSC’s nanotechnology data call-in as a backdrop. According to the preliminary agenda, the Symposium will feature two sessions. The first, entitled “Collaborative Efforts,” will discuss the key U.S. and international forums for collaboration on the health, safety, and environmental impacts of nanomaterials. The second session, “Company Engagement with Nanotechnology Safety,” will review examples of how companies can apply the evolving knowledge on nanomaterials safety to address systematically various areas of concern.

 

 

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The U.S. Environmental Protection Agency (EPA) announced in a September 16, 2009, Federal Register notice that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will meet November 3-6, 2009, “to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.” Nominations of candidates to serve as ad hoc SAP members for this meeting are due September 30, 2009. The meeting will be open to the public. EPA asks that written comments be submitted by October 20, 2009, to allow for distribution to the SAP, and that requests for oral comments be made by October 27, 2009.  EPA also states that written comments and requests to make oral comments may be submitted until the date of the meeting, however.

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The London School of Economics (LSE), Chatham House, the Environmental Law Institute (ELI), and the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars held a conference on September 10-11, 2009, on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies,” in London. LSE, Chatham House, ELI, and PEN are participating in an international collaborative project, Regulating Nanotechnologies in the EU and U.S., which is funded by a grant from the European Commission. Their research findings on issues of transatlantic regulatory cooperation were published in a report during the conference. The conference was intended to bring together regulatory experts from the United States (U.S.) and European Union (EU) to discuss recommendations from this research effort and to generate and examine new ideas that would enable greater transatlantic cooperation and convergence on nanotechnology oversight today and in the future. The materials released at the conference include a briefing paper entitled Regulating Nanomaterials:  A Transatlantic Agenda, and the report entitled Securing the Promise of Nanotechnologies:  Towards Transatlantic Regulatory Cooperation.

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On August 25, 2009, the United States Consumer Product Safety Commission (CPSC) held a public hearing to receive comments about its agenda and priorities for CPSC during fiscal year (FY) 2011, which begins October 1, 2010, and about its current strategic plan. CPSC invited participation by members of the public, and representatives from the Consumers Union, Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN), Thermo Fisher Scientific, National Association of State Fire Marshals, International Sleep Products Association, Kids in Danger, and American Apparel & Footwear Association testified. Don Mays, Consumers Union, and David Rejeski, PEN, addressed CPSC’s goals concerning nanomaterials.

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Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson will be speaking at the September 10-11, 2009, international conference on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies,” in London. The London School of Economics, Chatham House, the Environmental Law Institute, and the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars have spent the past year examining issues of transatlantic regulatory cooperation. During the conference, their research findings will be published in a major report, which is scheduled to be released on September 10, 2009. The conference is intended to bring together regulatory experts from the United States (US) and European Union (EU) to discuss recommendations from this research effort and to generate and examine new ideas that would enable greater transatlantic cooperation and convergence on nanotechnology oversight today and in the future.

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Today’s Federal Register includes a notice from the U.S. Environmental Protection Agency (EPA) withdrawing the June 24, 2009, final significant new use rules (SNUR) for multi- and single-walled carbon nanotubes (CNT). EPA states that it published the final SNURs using direct final rulemaking procedures. Because EPA received a notice of intent to submit adverse comments on the rules, it is withdrawing the SNURs for CNTs. The Federal Register notice does not identify the commenter. The docket for the rulemaking includes a July 22, 2009, letter from WilmerHale stating that it intends to submit adverse comments on behalf of one or more clients. According to the notice, EPA “intends to publish in the Federal Register, under separate notice and comment rulemaking procedures, proposed SNURS for these two chemical substances.” The withdrawal is effective August 21, 2009.

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In an August 7, 2009, letter to the White House Office of Science Technology and Policy (OSTP), the Environmental Council of the States (ECOS) expressed its interest in working with OSTP and other federal agencies regarding the “human health and ecological impacts and lifecycle consequences of intentional and unintentional releases of engineered nanoparticles into the environment.” According to ECOS, state environmental agencies want to participate in national efforts to develop best assessment and management practices. ECOS suggests that one option is for ECOS to join one or more of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee Working Groups within the National Nanotechnology Initiative (NNI) framework. ECOS asked OSTP for a meeting, “preferably this summer,” to obtain feedback on its key areas of interest and to discuss the best opportunities for its involvement in national efforts.

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In a notice in the August 4, 2009, Federal Register, the Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) released its latest report to the Administrator. Under TSCA Section 4(e), the ITC is required ‘‘to make recommendations to the Administrator respecting the chemical substances and mixtures to which the Administrator should give priority consideration for the promulgation of rules for testing.” According to the report, “the ITC has no revisions to the TSCA section 4(e) Priority Testing List at this time.”

The report also describes the ITC’s emphasis during the reporting period (November 2008 to May 2009) on nanoscale materials and how best to regulate them. It summarizes the ITC’s recent reviews of the U.S. Environmental Protection Agency’s (EPA) Nanoscale Materials Stewardship Program’s interim report and the National Institute for Occupational Safety and Health’s (NIOSH) nanotechnology guidelines. The report concludes by recommending data needs of ITC organizations be addressed and lists many of the data deficiencies.

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On July 28, 2009, the U.S. Environmental Protection Agency (EPA) clarified its June 24, 2009, final Significant New Use Rules (SNUR) for multi- and single-walled carbon nanotubes (CNT).  According to EPA, upon review of the final rule, stakeholders asked whether the SNURs applied to all types of CNTs.  EPA responded:

 

This is not the case.  These SNURs only apply to the specific carbon nanotubes that were the subject of the premanufacture notices (PMN) 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.

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Earlier this month, in advance of the Organization for Economic Cooperation and Development’s (OECD) July 15-17, 2009, Conference on Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-Led Growth, the Action Group on Erosion, Technology, and Concentration (ETC Group) issued a draft report entitled Nanogeopolitics 2009:  The Second Survey.  ETC Group recommends that policies concerning nanotechnologies be developed within the United Nations (UN) system, “where all nations can have a say about the technology and where the so-called nano-nations will come clean with everybody else about what they are doing to the economy and the environment.” The report is a follow up to the ETC Group’s 2005 survey of “the nanogeopolitical landscape.”  In the report, ETC Group reviews:  (1) the extent to which the “markets and players” have shifted position since 2005, especially in terms of research and funding; (2) the effectiveness of various governance and regulation; and (3) recommended action to regulate better and develop responsibly nanotechnology.

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On June 16, 2009, the Investor Environmental Health Network (IEHN) released a report entitled Bridging the Credibility Gap:  Eight Corporate Liability Accounting Loopholes that Regulators Must Close, which discusses the effect of undisclosed potential and pending liabilities on investors. The report identifies eight regulatory loopholes that businesses could use to hide future liabilities from an investor’s risk assessment. Two case studies for asbestos and nanomaterials are used to assess the effectiveness of current disclosure requirements and recommend improvements.

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On June 25, 2009, the Norwegian Board of Technology announced that the Norwegian Pollution Control Authority (SFT) has established “a scheme for Norwegian businesses to report their use of nanomaterials in chemical products.”  According to a spokesperson for the Board, until now the Norwegian market has “lacked oversight of nanomaterials.”  Under the scheme, information about nanomaterials in chemical products will be incorporated as a separate topic in declarations to the Norwegian Product Register, which is administered by the SFT. The initiative will supplement Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) due to its “focus on how substances are marketed and used in real life.”

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According to a June 8, 2009, article, Dr. Annette McCarthy of the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition stated on June 6, 2009, at the Institute of Food Technologists’ annual meeting that the “regulatory authority is sufficient to address nanotechnology but there are further questions.” McCarthy recommended that petitions to the FDA seeking acceptance of a nanotech food additive or coloring should address its “impact on identity and toxicity.” According to McCarthy, the idea of a Generally Regarded as Safe (GRAS) standard is not out of the question. Although a company “would have a hard time today” proving that a nanotechnology is generally recognized as safe, McCarthy thinks that “two years down the line, it could be a slam dunk; it could be very simple.

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On June 2, 2009, the United Kingdom (UK) released its response to the Royal Commission on Environmental Pollution (RCEP) Report entitled Novel Materials in the Environment: The Case of Nanotechnology. The RCEP looked at the properties of nanomaterials and the potential pathways by which they could enter and present potential hazards to the environment and people. The UK states that it shares RCEP’s “understanding that there is no evidence of actual harm resulting from the use of nanotechnologies, but accepts that this is a possibility and that there is a need to develop our understanding further.” The UK intends to develop a “UK Strategy for nanotechnologies,” which “will build on previous and existing activities and review the UK’s priorities and strategic direction.” The UK intends to begin in Summer 2009 an “evidence gathering exercise” with stakeholders to inform development of the Strategy.

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On May 28, 2009, during the Helsinki Chemicals Forum organized by the European Commission (EC) and European Chemicals Agency (ECHA), governmental spokespersons said that the way the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program applies to nanoscale substances is being reconsidered. ECHA Executive Director Geert Dancet stated that specific regulation of nanomaterials could be considered when the EC reviews REACH, which it is required to do by June 1, 2012. According to Dancet, the review could cover both the scope and implementation of REACH. Dancet stated that “nanomaterials will be covered in a more systematic way” following the review. European Union (EU) Environment Commissioner Stavros Dimas stated that “further work needs to be done to consider if further legislation is needed” to regulate nanomaterials. After the Forum, Dimas stated that separate legislation could be necessary to ensure to protect the environment and human health. According to Dimas, ECHA could manage nanomaterials, or EU legislation concerning fine particles could be used to regulate nanomaterials. The fine particle legislation concerns particles in air rather than in products, however, and a spokesperson for Dimas stated that the EC is “looking at all sorts of possibilities” and that specific approaches are “unexplored as yet.”

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According to a notice in the U.S. Environmental Protection Agency's (EPA) May 11, 2009, Regulatory Agenda, a Toxic Substances Control Act (TSCA) Section 4(a) test rule “may be needed to determine the health effects” of multiwall carbon nanotubes (CNT). EPA states that the results of the tests that could be required under the rule could assist in understanding the health effects of the substance to manage/minimize any potential risk and exposure. Results could also help with establishing a correlation between the chemical/physical properties and health effects needed to protect the health of workers handling the substance. EPA has not determined when it will publish a notice of proposed rulemaking (NPRM).

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During the June 29-July 1, 2009, meeting of the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Substances (GHS), the Committee will discuss a paper entitled “Ongoing Work on the Safety of Nanomaterials.” The paper provides a summary of current activities by the European Union (EU), including the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, International Organization for Standardization (ISO), and the Organization for Economic Cooperation and Development (OECD). The paper includes the following questions:

• Can it be considered, for the same chemical (same [Chemical Abstracts Service (CAS) Number] and purity) that nanomaterials with new properties have the same hazards as conventional form?
• Is it possible to distinguish for a same chemical, the properties of its different nanoforms?
• How can this be done? Should new endpoints be determined?
• To which extent information about nanomaterials need be provided?
• What kind of information is needed?
• What kind of communication tool is needed for this purpose?
• What kind of collaboration can be suggested in order to contribute to clarification of nanomaterials hazard classification and indeed to heath safety and environmental issues of nanomaterials?

 

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On April 28, 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Oversight of Next Generation Nanotechnology, which calls for the creation of the Department of Environmental and Consumer Protection, which would oversee product regulation, pollution control and monitoring, and technology assessment. According to report author J. Clarence Davies, Ph.D., the agency would be primarily a scientific agency with a strong oversight component, in contrast to current federal agencies such as the U.S. Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA), which are primarily oversight bodies. Davies stated: “New thinking, new laws and new organizational forms are necessary.  Many of these changes will take a decade or more to accomplish, but there is an urgent need given the rapid pace of technological change to start thinking about them now.”

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We are pleased to announce that Lynn L. Bergeson is included in the Nanotechnology Law & Business list of the top ten experts in environmental, health, and safety (EHS) issues related to engineered nanomaterials. Nanotechnology Law & Business states that they chose ten individuals with “substantial expertise” in EHS issues related to engineered nanomaterials and that they “expect these individuals to play leading roles in nanotechnology law and business.” Nanotechnology Law & Business is a peer-reviewed journal devoted to the legal, business, and policy aspects of small scale technologies.

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The European Commission (EC) will hold a scientific hearing on nanotechnology on September 10, 2009. The hearing will focus on the scientific aspects of the issues covered in the nanotechnology opinions issued by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the Scientific Committee on Consumer Products (SCCP) (which is now replaced by the Scientific Committee on Consumer Safety (SCCS)). To prepare for the hearing, the EC is launching a public consultation relating to the three main objectives to be addressed:

• Identification of any possible topics which have not been covered in the opinions from the relevant European Union (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.

The outcome of the consultation will be presented at the scientific hearing.  Comments are due June 19, 2009.

 

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In an April 24, 2009, press release, the European Parliament (EP) calls for the provision of information to consumers on the use of nanomaterials in consumer products. According to the EP, all ingredients present in the form of nanomaterials in substances, mixtures, or articles should be clearly indicated in the product labeling. The press release also specifically calls for the European Commission (EC) to evaluate the need to review the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) concerning:

• Simplified registration for nanomaterials manufactured or imported below one tonne;
• 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 on their own, in preparations, or in articles.

The EP also calls for the EC 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 detect reliably 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.

 

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On March 31, 2009, the European Parliament (EP) Committee on Environment, Public Health, and Food Safety amended and adopted a report on the regulatory aspects of nanomaterials. The January 2009 draft report was prepared by Swedish Green EP Member Carl Schlyter and urges tighter controls on nanotechnology. The report calls on the European Commission (EC) to review all relevant legislation to implement the principle “no data, no market” for all applications of nanomaterials in products with potential health, environmental, or safety impacts over their life cycle. The report reiterates the Committee’s call for labeling of consumer products containing nanomaterials, and recommends development of testing protocols and metrology standards to assess the hazard of, and exposure to, nanomaterials over their entire life cycle, using a multi-disciplinary approach. The report was adopted by a vote of 21-14.

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On March 27, 2009, Lloyd’s of London issued a news release entitled “Nanotechnology: Balancing Risk and Opportunity.” According to the news release, over the past 18 months, the Lloyd’s Emerging Risks team has been examining the potential threats associated with nanotechnology from an insurance perspective. The release states: “Like others in the insurance industry, Lloyd’s is alert to the potential for nano products to be associated with health and safety risks, whether real or perceived.” According to the release, Lloyd’s believes that research and regulation “are the two critical tools which can help society and its insurers to better understand and manage the potential risks.” Lloyd’s states:

Research should be better co-ordinated, both at a national and an international level, while the many diverse applications of nanotechnology need a coherent regulatory framework.

Both of these are challenges that industry and government need to work on together, and the insurance industry can play a valuable part in this work.

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On March 24, 2009, the European Parliament (EP) approved an update of European Union (EU) legislation on cosmetics. The new regulation is intended to remove legal uncertainties and inconsistencies, while increasing the safety of cosmetics. The regulation would replace 27 different regulations. The new regulation addresses nanomaterials used as cosmetics ingredients. As requested by the EP, 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. The EP also succeeded in requiring that any nanomaterials present in cosmetics be mentioned in the list of ingredients on the packaging. The new regulation also includes a definition of nanomaterials, which must be adapted by the European Commission (EC) in line with scientific and technological advances. Under the new regulation, nanomaterial would be defined as “an insoluble or bioresistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”

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On March 10, 2009, the Food and Drug Administration (FDA) announced a collaboration with the Alliance for NanoHealth (ANH) and its members. According to FDA, the collaboration is intended to “help speed development of safe and effective medical products in the emerging field of nanotechnology.” Under a memorandum of understanding, FDA and ANH will work to increase the knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that could mitigate the risks associated with nanoengineered products. FDA states that all outcomes “will be placed in the public domain for the benefit of all stakeholders.” The ANH member institutions include Baylor College of Medicine; the University of Texas’ M.D. Anderson Cancer Center; Rice University; the University of Houston; the University of Texas Health Science Center at Houston; Texas A & M Health Science Center; the University of Texas Medical Branch at Galveston; and the Methodist Hospital Research Institute.

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On March 6, 2009, the United Kingdom (UK) Health and Safety Executive (HSE) published an information sheet on the risk management of carbon nanotubes (CNT). According to HSE, the information sheet “is specifically about the manufacture and manipulation of carbon nanotubes and has been prepared in response to emerging evidence about the toxicology of these materials. However, the risk management principles detailed here are equally applicable to other nanodimensioned bio-persistent fibres with a similar aspect ratio.” HSE cites as “new evidence” a recent study by the University of Edinburgh, which “found that long, straight [multi-walled CNTs] with a high aspect ratio produced a marked inflammatory reaction and the formation of granulomas when injected into the abdominal cavity of mice.”

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On March 5, 2009, the European Food Safety Authority (EFSA) published a document entitled The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety, which provides its scientific opinion on the potential risks arising from nanoscience and nanotechnologies on food and feed safety. EFSA’s Scientific Committee (SC) concluded that established international approaches to risk assessment can also be applied to engineered nanomaterials (ENM).  The SC also concluded that a case-by-case approach would be necessary and that, in practice, current data limitations and a lack of validated test methodologies could make risk assessment of specific nano products very difficult and subject to a high degree of uncertainty. The opinion focuses on the use of nanotechnologies, particularly ENMs, in the food and feed chain.  It elaborates on approaches and methodologies available for risk assessment of these very small particles but does not address any specific applications of particular ENMs.

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During the February 18, 2009, Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, Dr. Jonathan Sackner-Bernstein, Associate Center Director for Post-Market Operations at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), stated that FDA will not issue guidance until companies bring products to them so that FDA can learn more about the effects of nanotechnology. Sackner-Bernstein acknowledged that the companies might not be submitting products due to “uncertainty over excessive burden from regulation.”  He described FDA’s role as “an encouraging gatekeeper,” and urged companies to submit their products and test results. Deputy Director Douglas Throckmorton, FDA Center for Drug Evaluation and Research (CDER), stated:  “We are at work understanding what we have at hand, developing a full inventory of nanoscale products before we get into the guidance business.  But I will say this, we know much less than we need to on the effect of nanoscale materials on manufacturing.” Norman Alderson, FDA Associate Commissioner for Science, described the challenges of nano-engineered materials, including the lack of: standards and reference materials; toxicological and biocompatibility data for most products; and standardized physical and chemical characterization procedures.

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On February 13, 2009, the National Nanotechnology Coordination Office (NNCO) released a statement regarding the National Research Council’s (NRC) December 10, 2008, report regarding its review of the National Nanotechnology Initiative (NNI) Strategy for Nanotechnology-Related Environmental, Health, and Safety (EHS) Research.  According to the statement, NNI member agencies noted the report’s “substantial and important recommendations for further progress on EHS research,” and “look forward to working with the NRC on achieving the vital and shared goals of clearly, proactively assessing the potential benefits and risks that may be associated with specific nanomaterials in specific applications.”  NNCO notes that it “do[es] not believe that the NRC evaluation recognized the breadth and depth of the NNI commitment to EHS research. . . .  Furthermore, the report drew a number of conclusions with which the NNI member agencies respectfully disagree.” NNCO provided detailed comments to the NRC in a January 5, 2009, letter. On February 24-25, 2009, NNCO held a workshop regarding the science related to EHS aspects of engineered nanoscale materials in the area of human and environmental exposure assessment, one of the five EHS research categories identified in the Strategy for Nanotechnology-Related Environmental, Health, and Safety Research.

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On March 19, 2009, the California Department of Toxic Substances Control (CDTSC) will hold a full-day nanotechnology symposium on nanomaterials regulation from a variety of perspectives. According to CDTSC, the symposium will focus on the regulatory aspects of nanotechnology, the role of the U.S. Environmental Protection Agency (EPA), and CDTSC’s chemical information call-in program including nanoscale materials. CDTSC states that federal interest in nanomaterial regulation and California’s efforts “provide a great opportunity for fostering technological advances that recognize environmental and public health concerns. The goal is to create a partnership where we can enhance research where needed and promote sustainable processes as well as applications.” Registration is required. The symposium will also be available via web cast.

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On December 15, 2008, the House of Lords Science and Technology Select Committee appointed a Subcommittee to investigate the use of nanotechnologies in the food sector.  The Committee intends to focus on the following areas:  food products, additives, and supplements; food contact packaging; food manufacturing processes; animal feed; pesticides and fertilizers; and products that may come into contact with food, such as food containers and cooking utensils.  The Committee requests evidence on questions under the following topics:

• State of the science and its current use in the food sector;
• Health and safety;
• Regulatory framework; and
• Public engagement and consumer information.

Submissions are due March 13, 2009. The Committee will hold public meetings beginning in Spring 2009, and intends to publish its report in Fall 2009.

 

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On February 3, 2009, Representative Mike Honda (D-CA) introduced the Nanotechnology Advancement and New Opportunities (NANO) Act (H.R. 820), which is intended to ensure the development and responsible stewardship of nanotechnology. Honda based the legislation on the recommendations of the Blue Ribbon Task Force on Nanotechnology, a panel of California nanotechnology experts with backgrounds in established industry, startup companies, consulting groups, non-profits, academia, government, medical research, and venture capital convened by Honda and then-California State Controller Steve Westly during 2005.

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On January 14, 2009, the Project on Emerging Nanotechnologies (PEN) released a report entitled A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements, which describes problems at the Food and Drug Administration (FDA) in regulating nano-enabled dietary supplements and offers recommendations for improving oversight. According to the report, FDA’s ability to regulate the safety of such dietary supplements “is severely limited by lack of information, lack of resources and the agency’s lack of statutory authority in certain critical areas.” The authors note that, under current law, supplement manufacturers must disclose only limited information about their products, and the information available is the result of manufacturers promoting their use of nanotechnology when marketing their products. PEN states that, according to its inventory of federal environmental, health, and safety research on nanotechnology, the U.S. government provides less than $1 million annually to study the direct impact of nanoscale materials on the gastrointestinal tract.

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In a January 22, 2009, letter, the California Department of Toxic Substances Control (CDTSC) announced that it is requiring the submission of data “regarding analytical test methods, fate and transport in the environment, and other relevant information from manufacturers of carbon nanotubes” (CNT). CDTSC states that the term “manufacturers” includes persons and businesses that produce CNTs in California or import CNTs into California for sale.  According to the letter, CDTSC is using its authority under California Health and Safety Code, Chapter 699, Sections 57018-57020. Section 57019(d)(2) requires that the data requested be provided within one year of the date of the letter.

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On January 15, 2009, Representative Bart Gordon (D-TN), Chair of the House Science Committee, introduced the National Nanotechnology Initiative (NNI) Amendments Act of 2009 (H.R. 554). The bill is identical to H.R. 5940, which passed the House in the previous Congress with a 407-6 vote. The legislation would reauthorize the multi-agency research program that Congress established in 2003 through the 21st Century Nanotechnology Research and Development Act of 2003 (Pub. Law 108-153). Under the Act, federal agencies would be required to develop a research plan and implementation strategy that specifies near- and long-term goals, sets milestones and time frames for meeting near-term goals, clarifies agencies’ roles in implementing the plan, and allocates sufficient resources to accomplish those goals. The bill would authorize funding for research in areas of national need, such as research to develop renewable energy and batteries that could store energy more efficiently, and would direct agencies to take steps to help private companies commercialize nanotechnology applications.

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According to a draft January 7, 2009, document, non-governmental organizations (NGO) such as Beyond Pesticides and the Pesticide Action Network for North America recommend that the Obama Administration take a number of immediate actions within its first 100 days, including establishing a moratorium on pesticidal nanotechnology. The NGOs call for the suspension of the registration of nanoproducts with pesticidal properties, and the removal of untested products from the market.  The NGOs urge the Obama Administration to direct the U.S. Environmental Protection Agency (EPA) to develop a clear testing protocol that identifies the full range of potential adverse health and environmental effects of nanoproducts with pesticidal properties. The NGOs cite the 60-day comment period on the International Center for Technology Assessment (ICTA) petition as an acknowledgment by EPA of “the critical need for in-depth review of products utilizing nanotechnology pesticides.” ICTA petitioned EPA in May 2008 to regulate nanoscale silver products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

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On January 12, 2009, the U.S. Environmental Protection Agency (EPA) released
its interim report on the Nanoscale Materials Stewardship Program (NMSP), which is a
voluntary program that EPA established to assemble existing data and information from
manufacturers and processors of certain nanoscale materials. Under the Basic Program, EPA
invited participants to voluntarily report available information on the engineered nanoscale
materials they manufacture, import, process, or use. As of December 8, 2008, 29 companies or
associations submitted information to EPA covering 123 nanoscale materials and a further seven
companies have outstanding commitments to the Basic Program. Under the In-Depth Program,
EPA invited participants to work on a plan for the development of data on representative
nanoscale materials over a longer time frame. As of December 8, 2008, four companies have
agreed to participate. EPA states that, based on the current interim results, “the NMSP can be
considered successful.” EPA notes that a number of the environmental health and safety data
gaps still exist, however, and “EPA is considering how to best use testing and information
gathering authorities under the Toxic Substances Control Act [(TSCA)] to help address those
gaps.”

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In a January 5, 2009, Federal Register notice, the U.S. Environmental Protection Agency (EPA) announces receipt of several premanufacture notices (PMN) concerning multi-walled carbon nanotubes (CNT). Under Section 5 of the Toxic Substances Control Act (TSCA), EPA requires any person who intends to manufacture (defined by statute to include import) a new chemical (i.e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. According to the notice, EPA received the CNT PMNs on September 17, 2008, and the projected end date was December 15, 2008. The submitter name is claimed as confidential business information (CBI). Comments on the PMNs are due February 4, 2009.

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In a December 12, 2008, Federal Register notice, the U.S. Environmental Protection Agency (EPA) announces receipt of several premanufacture notices (PMN) from Nano-C, Inc. concerning fullerenes. Under Section 5 of the Toxic Substances Control Act (TSCA), EPA requires any person who intends to manufacture (defined by statute to include import) a new chemical (i.e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. According to the notice, EPA received the fullerene PMNs on November 5, 2008, and the projected end date is February 2, 2009.  Comments on the PMNs are due January 12, 2009.

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According to a notice in the U.S. Environmental Protection Agency’s (EPA) November 24, 2008, Regulatory Agenda, EPA intends to publish an interim evaluation in March 2009 of the Nanoscale Materials Stewardship Program (NMSP), and a final evaluation of the NMSP, including next steps, in April 2010. The NMSP is a voluntary program that EPA established to assemble existing data and information from manufacturers and processors of certain nanoscale materials. The notice states that, under the Toxic Substances Control Act (TSCA), EPA has the authority to require the development of data necessary for risk assessment when statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard can be made, and to prevent and eliminate unreasonable risk of injury to human health and the environment.

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On November 19, 2008, the U.S. Environmental Protection Agency (EPA) announced the availability for review and comment of a petition requesting EPA regulate nanoscale silver products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to the notice, EPA “has determined that the petition raises issues that potentially affect private and public sector stakeholders.” The International Center for Technology Assessment (ICTA) and 13 other consumer, health, and environmental groups filed the petition. Comments are due January 20, 2009.

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On November 12, 2008, the United Kingdom (UK) Royal Commission on Environmental Pollution (RCEP) published a report entitled Novel Materials in the Environment: The Case of Nanotechnology, which examines issues related to innovation in the materials sector and the challenges and benefits arising from the introduction of nanomaterials. According to RCEP, there is an “urgent need for more testing, extending existing governance arrangements and creating new arrangements concerning nanomaterials.”  The report was prompted by concerns about potential releases to the environment from industrial applications of metals and minerals that have not previously been widely used. The RCEP states that, as the majority of the evidence it received was almost entirely focused on manufactured nanomaterials, it decided to focus on this sector as an exemplar. The report includes recommendations on how to address “ignorance and uncertainty in this area, which could also be applied to other areas of fast-paced technological development.”

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On October 17, 2008, the European Food Safety Authority (EFSA) began a public consultation on its draft scientific opinion in relation to nanoscience and nanotechnologies and food and feed safety.  EFSA’s draft opinion focuses on engineered nano materials (ENM) that could be deliberately introduced into the food chain and elaborates on approaches to risk assessment. EFSA states that it “is not an assessment of any specific application of ENM.” According to EFSA, the European Commission (EC) requested the opinion “as a first step because consideration needs to be given as to whether existing risk assessment approaches can be appropriately applied to this new technology.”  EFSA states that its final opinion “will then help the EC to explore appropriate measures, assess existing legislation and determine the scope of possible further requests for scientific opinions from EFSA in this field.” Comments are due December 1, 2008.

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On October 30, 2008, Consumers Union petitioned the Food and Drug Administration (FDA) to require a full safety assessment on the use of engineered nanoparticles, particularly in cosmetics, sunscreens, and sunblocks, and “to investigate possible enforcement action to ensure accurate labeling as to the presence or absence of nanoparticles.” Consumers Union cites new findings in the December 2008 issue of Consumer Reports, and states that the findings “confirm that use of certain nanoparticles is widespread in mineral-based sunscreens, and that company representatives are making erroneous assertions about these particles in their products.” Consumers Union purchased sunscreens that contain titanium dioxide and/or zinc oxide, focusing on products that, according to company representatives, do not contain nanoparticles. According to the Consumer Reports article, Consumers Union found that four of the five companies’ statements about their products, asserting that they did not contain nanoparticles, were incorrect.

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Last week, the U.S. Environmental Protection Agency posted a submission made by BASF Chemical Company under Section 8(e) of the Toxic Substances Control Act (TSCA), which requires U.S. chemical manufacturers, importers, processors and distributors to notify EPA within 30 calendar days of new, unpublished information on their chemicals that may lead to a conclusion of substantial risk to human health or to the environment. In its July 8, 2008, submission, BASF submitted the results of a subchronic inhalation study in rats, reporting that the no observed effect concentration is below 0.1 mg/m³. In a September 9, 2008, letter, EPA’s Office of Pollution Prevention and Toxics (OPPT) states that it conducts preliminary screens of all Section 8(e) submissions and routinely requests additional information from submitters to complete these preliminary screens or to evaluate submissions further. OPPT requested the complete report from BASF.

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According to the Office of the Federal Register, tomorrow the U.S. Environmental Protection Agency (EPA) will publish a notice regarding the Toxic Substances Control Act (TSCA) requirements potentially applicable to carbon nanotubes (CNT). EPA states that it “generally considers CNTs to be chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA Inventory.” As a result, many CNTs may therefore be new chemicals under TSCA Section 5. Manufacturers or importers of CNTs not on the TSCA Inventory must submit a premanufacture notice (PMN) (or applicable exemption) under TSCA Section 5 where required under 40 C.F.R. Part 720 or Part 723. To determine the TSCA Inventory status of a CNT, a manufacturer may submit to EPA a bona fide intent to manufacture or import under 40 C.F.R. Section 720.25.  According to the notice, some time after March 1, 2009, EPA anticipates focusing its compliance monitoring efforts to determine if companies are complying with TSCA Section 5 requirements for CNTs.

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On October 8, 2008, the European Commission (EC) published a regulation amending the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Annex IV to remove carbon and graphite. Although the substances were originally listed in Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties, a European Union (EU) expert committee delisted the substances in June 2008. According to the regulation, there is insufficient information for carbon and graphite to be listed in Annex IV, “in particular due to the fact that the concerned EINECS and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in this Annex.”

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The Environmental Defense Fund (EDF) recently posted two blog items regarding a consent order negotiated by the U.S. Environmental Protection Agency (EPA). The October 9, 2008, item states that EPA intends to issue a sanitized version of a consent order negotiated with a producer of multiwalled carbon nanotubes (MWCNT). According to EDF, the order was prompted by EPA’s review of a premanufacturing notification (PMN).

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On September 25, 2008, the International Organization for Standardization (ISO) announced the availability of ISO/TS 27687:2008, Nanotechnologies -- Terminology and Definitions for Nano-Objects -- Nanoparticle, Nanofibre and Nanoplate, which provides terms and definitions related to particles in the field of nanotechnologies. ISO states that it is “intended to facilitate communications between organizations and individuals in industry and those who interact with them.” The document is the first part of a projected series on terminology and definitions documents covering the different aspects of nanotechnologies.

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On September 18, 2008, the U.S. Environmental Protection Agency (EPA) announced that EPA Region 5 will host the 2008 International Environmental Nanotechnology Conference: Applications and Implications, October 7-9, 2008, in Chicago, Illinois. According to EPA, researchers from Asia, Australia, and Europe will join U.S. scientists and government officials to discuss nanotechnology applications for environmental cleanup, pollution control, and the implications of releasing engineered nanoparticles into the environment. Partner agencies represented at the conference include the Agency for Toxic Substances and Disease Registry (ATSDR), National Institute of Environmental Health Sciences (NIEHS), National Science Foundation (NSF), U.S. Army, U.S. Navy, U.S. Department of Energy (DOE), and University of Illinois at Chicago’s Great Lakes Centers for Occupational and Environmental Safety and Health.

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On September 10, 2008, the European Commission (EC) requested companies to submit data “with regard to all substances used at nano-scale and the final [cosmetic] products in which they are used.” Citing the December 18, 2007, opinion of the Scientific Committee on Consumer Products concerning the safety of nanomaterials in cosmetic products and the June 22, 2007, opinion of the Scientific Committee on Emerging and Newly-Identified Health Risks regarding the appropriateness of the risk assessment methodology in assessing the risks of nanomaterials, the EC states that “there is an urgent need for closing the information gap and even the methodological gap with regard to nanomaterials in cosmetics.  Without these gaps being closed, it will, in the medium term, be hardly defendable for industry and authorities to assert that cosmetic products containing nanomaterials are safe.”

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The August 2008 issue of The Lancet Oncology includes an article entitled “Special Report: Policy -- Future Priorities for IARC Monographs.” According to the article, carbon-based nanomaterials and ultrafine particles are included on the list of substances recommended by the International Agency for Research on Cancer (IARC) Advisory Group as high priority for assessment. The article states that carbon-based nanomaterials are “present in many consumer products; carbon nanotubes induce irreversible lung fibrosis and mesothelioma in animals.” Ultrafine particles, according to the article, were recommended because “cancer concerns arise from core particles and chemicals that adhere to their surfaces.” The Advisory Group met in June 2008 to consider nominations for review in future IARC monographs.

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The United States Food and Drug Administration (FDA) held its publicized Public Meeting on Nanotechnology on Monday, September 8, 2008, near its main offices in Rockville, Maryland. The meeting consisted of a plenary session led by Dr. Norris Alderson, Co-Chair of the FDA Nanotechnology Task Force, followed by separate breakout sessions for prescription and over-the-counter (OTC) drugs, cosmetics, medical devices, food and color additives (including food contact substances), and dietary supplements.  In general, the meeting yielded no new information pertinent to FDA’s nanotechnology plans or policies.

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Recent press reports have indicated, and an attorney with the International Center for Technology Assessment (ICTA) has confirmed, that the U.S. Environmental Protection Agency (EPA) contacted ICTA last week and informed the organization that it (EPA) intends to seek public comment on the nanoscale silver petition filed by ICTA and 13 other consumer, health, and environmental groups on May 1, 2008. The petition demanded, inter alia, that EPA regulate as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act consumer products containing nanoscale silver. The petitioners requested that EPA respond to the petition “within a reasonable time.”

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In its latest Background Paper, entitled Mounting Evidence That Carbon Nanotubes May Be the New Asbestos, Friends of the Earth Australia (FOEA) is calling “for an immediate moratorium on the commercial use of carbon nanotubes and the sale of products that incorporate nanotubes until research can demonstrate whether or not there is any safe level of exposure to them.”   FOEA also is calling for new nanotechnology-specific regulation to protect human health and the environment, as well as for mandatory labeling of all nanoscale materials used in the workplace and in consumer products.

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 On August 21, 2008, the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars released its latest nanotechnology report, The Consumer Products Safety Commission and Nanotechnology, written by Dr. E. Marla Felcher. Dr. Felcher states that “[a] rapid increase in both the number and complexity of [nanotechnology-enabled consumer] products places significant responsibility on [the U.S. Consumer Product Safety Commission (CPSC)] to take the lead in regulating this new technology, but the agency is not in a position to do so.” After providing a brief history of the CPSC, Dr. Felcher asserts that the agency “has never lived up to its expectations,” and highlights five weaknesses in CPSC’s oversight capacity as exemplifying why CPSC is unable “to oversee the safety of complex, high-tech products made using nanotechnology”:

1. Its data collection system is not nano ready;
2. It has limited ability to inform the public about health hazards associated with nanotechnology products;
3. It has limited ability to ensure that recalled products are removed from store shelves;
4. It lacks sufficient enforcement personnel to identify manufacturers that fail to report nanotechnology product hazards; and
5. It does not have sufficient authority to promulgate mandatory safety standards for nanotechnology products.

 

 

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In an August 7, 2008, Federal Register notice, the U.S. Food and Drug Administration (FDA) announced that it will convene a public meeting on September 8, 2008, on FDA-regulated products that may contain nanoscale materials. According to the Federal Register notice, FDA also is seeking public comments and available data “that will assist [FDA] in further implementing the recommendations of the Nanotechnology Task Force Report . . . relating to the development of agency guidances.” Written comments in response to the Federal Register notice must be received by FDA no later than October 24, 2008. Continue Reading...

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On July 28, 2008, the City Council of Cambridge, Massachusetts voted to accept a set of recommendations for a municipal health and safety policy on nanomaterials. The recommendations were set forth in a report prepared by the Cambridge Public Health Department (CPHD) and the Cambridge Nanomaterials Advisory Committee (CNAC). Cambridge now becomes the second city in the United States -- Berkeley, California is the other -- to have taken municipal action on nanomaterials. Continue Reading...

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We are pleased to announce that CRC Press has published Nanotechnology and the Environment, which Lynn L. Bergeson co-authored. Nanotechnology and the Environment includes a general explanation of nanomaterials, their properties, and their uses; describes the processes used to manufacture nanoscale materials; furnishes information on the analysis of nanomaterials in the environment and their fate and transport, including the effects of wastewater treatment on nanomaterials; discusses possible risks to human health and the environment; and describes developing regulations to manage those risks. Continue Reading...

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On July 22, 2008, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) posted a web page entitled “Pesticide Issues in the Works:  Nanotechnology, the Science of Small.” The web page states: “[The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] and EPA’s implementing regulations provide an effective framework for regulating pesticide products that are a product of nanotechnology or that contain nanoscale materials.” According to the page, “EPA is currently examining potential hazard, exposure, policy, regulatory, and international issues that may be associated with pesticides that are a product of nanotechnology or that contain nanoscale materials.” While EPA has met with several companies “to discuss requirements for some specific nanoscale materials being considered for use as pesticides,” EPA has not yet received a formal registration application. EPA “strongly recommends” that companies contact the pesticide registration Ombudsmen “to arrange a pre-application conference as early as possible in the development of any pesticide that would be a product of nanotechnology or that would contain nanoscale material.”

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On July 22, 2008, Jim Willis stated that the U.S. Environmental Protection Agency (EPA) is prepared to issue a rule under Section 8 of the Toxic Substances Control Act (TSCA) to obtain data regarding nanoscale materials. Under the Nanoscale Materials Stewardship Program (NMSP) Basic Program, EPA asked companies to report data voluntarily on the engineered nanoscale materials they manufacture, import, process, or use. As of July 22, 2008, manufacturers of approximately 60 nanoscale materials had responded to EPA that they would participate in the NMSP. Willis stated that he hoped more companies would participate, so that data on about 100 nanoscale materials would be provided. The deadline for submissions under the Basic Program is July 28, 2008. Continue Reading...

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On July 17, 2007, Senators Daniel K. Inouye (D-HI), Chair of the Commerce, Science, and Transportation Committee, John Kerry (D-MA), Olympia Snowe (R-ME), Ted Stevens (R-AK), Mark Pryor (D-AR) and Gordon Smith (R-OR) introduced the National Nanotechnology Initiative Amendments Act of 2008. The bill would reauthorize the National Nanotechnology Initiative (NNI) and amend aspects of the program to prioritize better research and development activities. Continue Reading...

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On June 26, 2008, the European Trade Union Confederation (ETUC) passed a resolution on nanotechnologies and nanomaterials, which calls for the application of the precautionary principle. The resolution states that application of the precautionary principle is necessary to avoid “past mistakes [made] with putatively ‘miracle’ technologies and materials. According to ETUC, the number of workers coming into contact with nanomaterials will increase sharply as nanotechnologies are applied to difference industry sectors, including the chemical, pharmaceutical, and electronics industries. The ETUC urges the European Commission (EC) to amend the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation “so as to give better and wider coverage to all potentially manufacturable nanomaterials.” Because nanomaterials are manufactured or imported below the threshold of one tonne per year and may evade the REACH registration requirements, “ETUC demands that different thresholds and/or units (e.g., surface area per volume) are used for registration of nanomaterials under REACH.” Continue Reading...

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On June 25, 2008, the Project on Emerging Nanotechnologies (PEN) and the Grocery Manufacturers Association (GMA) released a report entitled Assuring the Safety of Nanomaterials in Food Packaging: The Regulatory Process and Key Issues, which concludes that engineered nanoscale materials use in food packaging materials raise new safety evaluation challenges for regulators and industry. The report uses hypothetical food packaging applications to examine how the regulatory process would apply to nanotech food packaging materials and to identify issues that should be addressed to ensure the process works effectively. According to the report, the unique focus of its dialogue among experts and stakeholders from government, industry, and the public interest community was “upstream” -- on products that have not yet been commercialized, but which contain features of products that would likely move from development into the marketplace.

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We are pleased to announce that Lynn L. Bergeson will be speaking on June 2, 2008, at the Nano Science and Technology Institute (NSTI) Nanotech 2008 conference, which will run from June 1-5, 2008. She will be participating in a session on the U.S. Environmental Protection Agency’s Nanoscale Materials Stewardship Program. In addition, she is a co-presenter of the poster entitled “Nanomaterials down the drain: perception and reality.”

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On May 19, 2008, the Department for Environment, Food, and Rural Affairs (DEFRA) posted its sixth quarterly report on the Voluntary Reporting Scheme (VRS) for engineered nanoscale materials. According to the report, DEFRA received no new submissions this quarter, and to date has received only nine submissions since the VRS’s launch in September 2006:  seven from industry, and two from academia. The report states that DEFRA, in partnership with the United Kingdom Technology Strategy Board, is funding a telephone survey of selected companies and researchers.  DEFRA intends the survey, to be undertaken between May and August 2008, to find out more about the nature of these companies/researchers’ activities in the field of nanotechnologies.  As part of this process, DEFRA will offer assistance to those wishing to submit data to the VRS, in the form of telephone advice or site visits.  All information collected as part of this process will be treated as confidential unless the data owner advises to the contrary.

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On May 20, 2006, the U.S. Environmental Protection Agency (EPA) stated that it would like to initiate discussions regarding testing of nanoscale materials under the in-depth portion of the Nanoscale Materials Stewardship Program (NMSP). Under the NMSP, companies that manufacture, import, process, or use nanoscale materials for commercial purposes voluntarily submit data to EPA and also participate in the development of additional data. To date, EPA has received three submissions for nanoscale materials under the basic program. EPA has also received commitments from ten additional companies to submit data on nanoscale materials under the basic program. Thus far, no one has signed up to participate in the in-depth portion of the NMSP, however. EPA encourages anyone interested in starting this dialogue to contact it. Continue Reading...

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The U.S. Environmental Protection Agency’s (EPA) May 5, 2008, Unified Agenda includes an item regarding the Nanoscale Materials Stewardship Program (NMSP), which is a voluntary program that EPA established to assemble existing data and information from manufacturers and processors of certain nanoscale materials. The notice states that, under the Toxic Substances Control Act (TSCA), EPA has the authority to require the development of data necessary for risk assessment when statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard can be made, and to prevent and eliminate unreasonable risk of injury to human health and the environment. On January 28, 2008, EPA announced the NMSP. According to the Unified Agenda notice, EPA intends to publish in March 2009 an interim evaluation of the NMSP, and a final evaluation of the NMSP, “including next steps,” in April 2010.

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On May 1, 2008, the International Center for Technology Assessment (ICTA), together with 13 other consumer, health, and environmental groups, filed a petition with the U.S. Environmental Protection Agency (EPA) demanding that EPA regulate as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and that it take additional actions under FIFRA and other environmental statutes concerning, consumer products containing nanoscale silver. ICTA also released an inventory of the nano silver-containing consumer products referenced in the petition. Continue Reading...

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On April 24, 2008, the U.S. Government Accountability Office (GAO) released a report entitled Nanotechnology: Accuracy of Data on Federally Funded Environmental, Health, and Safety Research Could Be Improved, which contains the testimony of Robert A. Robinson, Managing Director, Natural Resources and Environment, before the Senate Committee on Commerce, Science, and Transportation Subcommittee on Science, Technology, and Innovation. Robinson provided a summary of GAO’s findings as reported in its March 31, 2008, report entitled Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of Federal Research Focused on Environmental, Health, and Safety Risks. GAO was asked to focus on: (1) the extent to which selected agencies conducted environmental, health, and safety (EHS) research in fiscal year (FY) 2006; (2) the reasonableness of the agencies’ and the National Nanotechnology Initiative’s (NNI) processes to identify and prioritize EHS research; and (3) the effectiveness of the agencies’ and the NNI’s process to coordinate EHS research. Continue Reading...

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On April 24, 2008, the Senate Committee on Commerce, Science, and Transportation will hold a hearing entitled “National Nanotechnology Initiative: Charting the Course for Reauthorization.” The National Nanotechnology Initiative (NNI) currently receives approximately $1.5 billion. The hearing will examine the five-year period since the NNI was initially authorized in 2003 and explore issues the Committee should consider for the next reauthorization.  

Witnesses scheduled to speak at the hearing include:

• Panel 1

• The Honorable Richard M. Russell
  Associate Director and Deputy Director for Technology
  Executive Office of the President 
• Mr. Robert A. Robinson
  Managing Director, Natural Resources and Environment Team
  U.S. Government Accountability Office

• Panel 2

• Mr. Matthew M. Nordan
  President
  Lux Research Incorporated 
• Mr. David Rejeski
  Director, Foresight and Governance Project and Project on Emerging Nanotechnologies
  Woodrow Wilson Center  
• Dr. P. Lee Ferguson
  Assistant Professor, Department of Chemistry and Biochemistry
  University of South Carolina 
• Dr. Anita Goel
  Nanobiosym Incorporated
• Dr. Jim Heath
  Director
  NSB Cancer Center

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On March 11, 2008, the German Chemical Industry Association (VCI) released a report entitled Responsible Production and Use of Nanomaterials, which is a series of documents intended to provide guidance on all aspects of a good product stewardship on nanomaterials. The documents include joint papers prepared by VCI and the German Federal Institute for Occupational Safety and Health (BAuA) and the German Society for Chemical Engineering and Biotechnology (DECHEMA). The report includes the following documents:

Principles Document:

• Implementing Responsible Care® for a Responsible Production and Use of Nanomaterials

Regulatory Documents:

• Requirements of the REACH Regulation on Substances Which Are Manufactured or Imported also as Nanomaterials
• Guidance for a Tiered Gathering of Hazard Information for the Risk Assessment of Nanomaterials
• Guidance for Handling and Use of Nanomaterials at the Workplace
• Guidance for the Passing on of Information along the Supply Chain in the Handling of Nanomaterials via Safety Data Sheets
• Strategy Paper of the German Chemical Industry on the Standardization of Nanomaterials

Documents on Safety Research:

• Roadmap for Safety Research on Nanomaterials
• Environmental Aspects of Nanoparticles

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On April 9, 2008, the Project on Emerging Nanotechnologies (PEN) released a report entitled Room at the Bottom? Potential State and Local Strategies for Managing the Risks and Benefits of Nanotechnology. According to the report, because of the slow pace of federal action to regulate development of nanotechnology, “there is ‘room at the bottom’ for state and local governments to move forward in pursuing regulatory and other oversight options.” Research for the report identified a number of states with laws promoting the nanotechnology industry or other initiatives encouraging research and development on nanotechnology applications. The report states that each of the 50 states is “home to at least one company, university, government laboratory, or other type of organization working with nanomaterials.” Continue Reading...

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On April 2, 2008, the Silicon Valley Toxics Coalition (SVTC) released a report entitled Regulating Emerging Technologies in Silicon Valley and Beyond: Lessons Learned from 1981 Chemical Spills in the Electronics Industry and Implications for Regulating Nanotechnology.  According to SVTC, the emergence of nanotechnology is similar to the electronics industry in the early 1980s, when new manufacturing processes ultimately resulted in groundwater pollution throughout Santa Clara County. The report provides a case study of the regulatory landscape in Santa Clara County and traces the “clear and alarming parallels” to current regulations for nanotechnology. SVTC outlines recommendations for policy reform, based on closing existing gaps in data, technology, and safety. The report includes a set of sample questions that SVTC intends for communities to use to gather information about the use and safety of nanomaterials and processes in nearby facilities. Continue Reading...

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On March 25, 2008, the National Institute for Occupational Safety and Health (NIOSH) posted fact sheets regarding several initiatives for which it seeks participants. NIOSH states that the initiatives are fully funded by NIOSH, and there is no monetary cost to the participant.  The first two fact sheets concern NIOSH’s Nanotechnology Field Research Team, which is available to conduct site visits at facilities involved in the research, manufacture, or use of various types of nanomaterials. The third fact sheet describes NIOSH’s metal oxide particle exposure assessment study, for which NIOSH seeks manufacturers and end-users of fine and ultrafine metal oxides. Continue Reading...

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On April 25, 2008, the California Nanosystems Institute (CNSI) will hold a conference entitled “The Future of Nanotechnology: A Legislative Summit.” The conference sponsors include California Assembly Member Mike Feuer (AD 42-D), Office of the Vice Chancellor for Research (OVCR), State Government Relations (SGR), and CNSI. Panelists include Lenny Rome, Ph.D.; Andre Nel, Ph.D., MD; John Froines, Ph.D.; Hilary Godwin, Ph.D.; Tim Malloy, JD; and Jeffrey Wong. CNSI describes the conference as “the first step for stakeholders from industry, government, research institutes and environmental groups to discuss responsible ways to regulate nanotechnology without stifling progress.”

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DuPont and Environmental Defense (ED) will hold two interactive workshops on nano risk management. The workshops are intended to give participants the tools they need to:

• Understand (and explain to others) why nano-specific risk management is necessary;
• Assemble and leverage the internal and external resources to implement nano-specific risk management; and
• Begin implementing nano-specific risk management in an efficient and effective manner.

The workshops will include:

• Interactive discussions of how to implement nano-specific risk management;
• Case studies of nano-specific risk management in use by companies and governments; and
• Sources of additional help for companies adopting these approaches.

The first workshop will be held April 2, 2008, at the Sustainable Packaging Coalition in San Francisco, California. A second workshop will be held April 8, 2008, at the Toxics Use Reduction Institute in Boston, Massachusetts.

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On March 12, 2008, the Department for Environment, Food and Rural Affairs (DEFRA) released a supplementary guidance document for the Voluntary Reporting Scheme (VRS). DEFRA prepared the supplementary guidance document to complement the existing VRS guidance. Chapter 2 describes the rationale and benefits of the VRS. Chapter 3 provides a specific list of the relevant physical, chemical, toxicological, and ecotoxicological data to include when reporting under the VRS, and the relevant hazard, exposure, and risk context for the information requested.  Chapter 4 sets out a context and summary for nanomaterial hazard and risk to human health and the environment. DEFRA intends the VRS to develop a better understanding of the properties and characteristics of different engineered nanoscale materials, so enabling potential hazard, exposure, and risk to be considered.  According to DEFRA, “[b]uilding an evidence-base in this way will allow for a more informed debate about the nature of appropriate controls.”

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The U.S. Patent and Trademark Office (PTO) will hold a Nanotechnology Customer Partnership meeting on April 22, 2008. According to PTO, it intends the Partnership to provide a forum to share ideas, experiences, and insights between individual users and PTO. PTO states that it does not intend to use the Partnership to arrive at a group consensus.  Individual opinions are sought from varying participants, and the meetings are intended to be informal in nature.  Due to space limitations, PTO asks attendees to RSVP by e-mail or telephone to Jill Warden at (571) 272-1267 to confirm attendance.  If it becomes necessary to restrict the number of attendees, PTO will do so on a first come, first served basis.

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A recent report released by Friends of the Earth (FOE) calls for a moratorium “on the further commercial release of food products, food packaging, food contact materials and agrochemicals that contain manufactured nanomaterials until nanotechnology-specific safety laws are established and the public is involved in decision making.” The report, entitled Out of the Laboratory and on to Our Plates:  Nanotechnology in Food & Agriculture, lists 104 commercially available foods, nutritional supplements, food contact materials, and agricultural chemicals identified by FOE that contain manufactured nanomaterials.  According to FOE, due to the “reluctance of food manufacturers to discuss their use of nanotechnology,” this list likely “represents only a small fraction of commercially available products that contain nanomaterials.” FOE states that many more nanofood products are in development, and many of the world’s largest food companies are exploring nanotechnology for food processing and packaging.  Many of the world’s largest agrochemicals and seed companies also have active nanotechnology research and development programs. FOE claims that regulations in the U.S., Europe, and Australia fail to address nanomaterials and calls for nano-specific food regulation to ensure food safety.

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On April 17-18, 2008, the European Commission (EC) will hold a workshop on research on the safety of nanomaterials. The main objectives of the workshop are:

• To increase interactions between researchers to enhance networking, sharing of outcomes of the research projects, and boosting synergies between research groups across Europe and abroad;
• To improve communication of the results of research to risk assessment bodies and other interested parties, providing sound science-based data for informing opinions and scientific advice to policy makers; and
• To examine the current knowledge to review, if need be, the priorities in safety of nanomaterials’ research.

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Last week the National Institute for Occupational Safety and Health (NIOSH) requested comments on its Strategic Plan for NIOSH Nanotechnology Research and Guidance:  Filling the Knowledge Gaps (Strategic Plan).  NIOSH intends the Strategic Plan “to provide a tool for coordinating nanotechnology research across the Institute and to provide a guide for enhancing the development of new research efforts that will respond to the challenges of working with a new technology.” According to NIOSH, the Strategic Plan “represents a cohesive, multidimensional, and timely research agenda for addressing knowledge gaps concerning possible worker exposures to nanomaterials, the health risks from such exposure, and development of control technology and prevention measures.” Comments are due June 1, 2008. Continue Reading...

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On February 29, 2008, the U.S. Environmental Protection Agency (EPA) announced a March 17-18, 2008, public meeting “to discuss opportunities for industry-government partnerships to foster greater public awareness of the environmental attributes of household and institutional consumer products and help make consumers aware of efforts on the part of consumer product manufacturers to improve the environmental performance of their products and production facilities.” According to EPA, the primary purpose of the initial meeting, which has received little notice to date, is “to establish a dialog among government, industry, and public stakeholders leading to formation of a Consumer Products Environmental Partnerships Working Group.” EPA states that, once formed, the Working Group will identify and develop possible partnership approaches such as product labeling, consumer education programs, environmental information websites, product stewardship programs, and manufacturer recognition programs. It describes the increased use of nanomaterials in consumer products as “an emerging issue.” To attend the meeting, which will be held in Research Triangle Park, North Carolina, EPA asks for the submission of name and affiliation by e-mail or telephone to Mr. Bruce Moore, EPA, Office of Air Quality Planning and Standards, at (919) 541-5460 no later than March 13, 2008.

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The European Commission’s (EC) Scientific Committee on Consumer Products (SCCP) released on March 3, 2008, a document entitled Opinion on Safety of Nanomaterials in Cosmetic Products (Opinion). In its Opinion, the SCCP divides nanoparticles into two groups: 1) soluble and/or biodegradable nanoparticles; and 2) insoluble particles. The SCCP states that, for the soluble and/or biodegradable group, “conventional risk assessment methodologies based on mass metrics may be adequate, whereas for the insoluble particles other metrics, such as the number of particles, and their surface area as well as their distribution are also required.” According to the SCCP, when assessing possible risks associated with nanoparticles, it is crucial to consider their uptake, and that it is primarily for the insoluble particles that health concerns related to possible uptake may arise. The SCCP concludes that, at present, there is inadequate information on: hazard identification; exposure assessment; uptake; the role of physico-chemical parameters of nanoparticles determining absorption and transport across membranes in the gut and lungs; the role of physico-chemical parameters of nanoparticles in systemic circulation determining biokinetics and accumulation in secondary target organs; possible health effects; and translocation of nanoparticles via the placenta to the fetus. The Opinion states that review of the safety of the insoluble nanomaterials presently used in sunscreens is required.

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On February 22, 2008, the European Commission (EC) announced the European Nanoelectronics Initiative Advisory Council (ENIAC) Joint Technology Initiative (JTI), which is endorsed by the Council of Ministers and by the European Parliament. Over the next ten years, € 3 billion will be invested in nanoelectronics.  The ENIAC JIT is a public-private partnership that targets nanoelectronics.  Under the ENIAC JIT, the EC and European Union (EU) member states who wish to participate will pool their public funding with universities and industry, including many innovative small- and medium-sized enterprises (SME), by setting up public-private partnerships. According to the EC, while research funding in nanoelectronics so far tends to be fragmented in small projects funded by individual member states and agencies, the ENIAC JIT will allow member states and the EC “to co-operate and co-finance pan-European research initiatives focus[]ed on a strategic agenda set by Industry itself.” The following member states participate in ENIAC: Austria, Belgium, Czech Republic, Estonia, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Spain, Sweden, and the United Kingdom.  The Governing Boards of the ENIAC JIT held its first meeting on February 22, 2008.

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On February 26, 2008, the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars released a brief entitled Application of the Toxics Release Inventory to Nanomaterials, which examines whether the Emergency Planning and Community-Right to-Know Act (EPCRA) and the Toxics Release Inventory (TRI) could be applied to nanomaterials. According to the brief, although several organizations have analyzed whether specific environmental laws could be used to regulate nanomaterials, none has examined EPCRA or TRI in any detail. Under TRI, the owners and operators of certain facilities are required annually to complete a toxic chemical release form for each listed toxic chemical manufactured, processed, or otherwise used in a certain quantity in the preceding year. The brief discusses how the following requirements may apply to nanomaterials: facilities; toxic chemicals; threshold amounts; and information reported.

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The European Commission (EC) asked its Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for a scientific opinion on the risk assessment of products of nanotechnologies. The request asks SCENIHR to identify and assess new information and update its opinions on the potential risks of products of nanotechnologies, “in particular, with respect to characterisation, eco-toxicology and toxicology as well as exposure assessments.” The EC’s request for an opinion states that the update “should be done in a step-wise manner taking into account the upcoming risk assessment demands related to specific nanomaterials and the evolving scientific information from various sources, including results from scientific research projects and activities of the European Technology Platforms related to the safety of nanomaterials. The deadline for the opinion is November 2008.

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On February 14, 2008, the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the National Science and Technology Council’s Committee on Technology released a final document entitled Strategy for Nanotechnology-Related Environmental, Health, and Safety Research, which describes the National Nanotechnology Initiative’s (NNI) strategy for addressing priority research on the environment, health, and safety (EHS) aspects of nanomaterials. The NNI EHS Strategy assigns priority to research and information needs identified by the NSET Subcommittee. NNI released an interim version of the EHS Strategy in August 2007, entitled Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment. NNI incorporated public comments in preparing the final EHS Strategy. The Nanotechnology Environmental and Health Implications (NEHI) Working Group developed the EHS Strategy “to accelerate progress in research to protect public health and the environment, and to fill gaps in, and -- with the growing level of effort worldwide -- to avoid unnecessary duplication of, such research.”

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On February 13, 2008, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft report entitled Draft Nanomaterial Research Strategy (NRS), which is intended to guide EPA’s Office of Research and Development in nanomaterial research.  Versar, Inc., an EPA contractor for external peer review, will convene a panel of experts and organize and conduct an independent expert external peer meeting on April 11, 2008, to review EPA’s draft NRS. Comments on EPA’s draft NRS are due March 14, 2008. Members of the public may register to attend the April 11, 2008, peer review meeting as observers. In addition, there will be time in the afternoon for attendees to give oral comments or provide written comments at the meeting.

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On February 8, 2008, the European Commission (EC) announced the adoption of a code of conduct for responsible nanosciences and nanotechnologies (N&N) research. The EC recommends that member states adopt codes of conduct to govern N&N research.  The EC code of conduct is based on seven general principles that address issues such as sustainability, precaution, inclusiveness, and accountability. The code of conduct also provides guidelines that implement these principles under good governance of research; due respect of precaution; and dissemination and monitoring of the code of conduct. The EC invites member states to take concrete action involving universities, research institutes, and companies for the safe development and use of nanotechnologies. Continue Reading...

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On January 23, 2008, the European Food Safety Authority (EFSA) issued a notice entitled “Call for Scientific Data on Applications of Nanotechnology and Nanomaterials used in Food and Feed.” According to the notice, EFSA is seeking data that could be useful as it prepares an initial scientific opinion for the European Commission (EC) regarding the risks arising from nanoscience and nanotechnologies on food and feed safety and the environment. The EC asked EFSA to identify the nature of the possible hazards associated with actual and foreseen applications in the food and feed area, and to provide general guidance on data needed for the risk assessment of such technologies and applications. EFSA intends to release a draft of its opinion in July 2008. Data submissions to EFSA are due March 28, 2008. Continue Reading...

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According to a January 22, 2008, Congressional Research Service (CRS) report entitled Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges, questions about the need for, and ideal form of, nanotechnology regulations are “exceedingly difficult” to address, given the current state of scientific understanding. CRS considered challenges faced by scientists, entrepreneurs, and agency officials involved in the National Nanotechnology Program as they work to define the characteristics of nanomaterials; the environmental, human health, and safety (EHS) risks they might pose; and how any potential risks should be addressed. The report states that challenges include the wide variety of nanomaterials and applications; lack of basic information about their properties; lack of conventions for naming, measuring, and identifying nanomaterials; the proprietary nature of some critical information; the need to prioritize federal resource needs; and a possible lack of clear statutory authority or appropriate regulatory framework to anticipate or respond to any identified risks. CRS states that, should Congress choose to intervene, it might choose any of several approaches: increasing funding for workshops in standardization or other research relevant to identifying and possibly ameliorating any EHS concerns associated with nanomaterials; changing the allocation of research money among agencies or the interagency research management structure; adopting a national or international research strategy; or enacting legislation that authorizes, mandates, or constrains agency actions to require information collection or to restrict production, sale, use, or disposal of nanomaterials.

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In today’s Federal Register, the U.S. Environmental Protection Agency (EPA) published a notice describing the design and format of EPA’s voluntary Nanoscale Materials Stewardship Program (NMSP) for nanoscale materials under the Toxic Substances Control Act (TSCA). EPA intends the NMSP “to complement and support its new and existing chemical efforts on nanoscale materials” under TSCA. Participants may participate in a basic program by submitting existing data, or may participate in an in-depth program to test engineered nanoscale materials. EPA intends to publish a summarized interim report approximately one year after the initiation of the NMSP, which will be based on data reported during the first six months of the basic program. EPA will then develop a more detailed report reflecting its evaluation of the NMSP approximately two years after initiation of the NMSP.

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According to a report recently released by the Danish Ministry of Health and Prevention, nanotechnology research, development, and applications are covered by existing legislation. The report, which includes an English summary, reviews existing national and international legislation in the areas of foods, medicines, the environment, chemicals, and the working environment in relation to current knowledge of nanotechnological products and processes.  The report also includes a chapter on national and international research policy activities, and describes the initiatives, working groups, and network groups the relevant government departments are taking part in, both nationally and internationally. The working group that prepared the report included representatives from the Ministry of the Interior and Health, the Danish Board of Health, the Danish Environmental Protection Agency, the Danish Medicines Agency, the Danish Veterinary and Food Administration, the National Food Institute at the Technical University of Denmark, the Danish Agency for Science, Technology, and Innovation, the Danish Working Environment Authority, and Danish Standards. Continue Reading...

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According to the December 22, 2007, fifth quarterly report for the Department for Environment, Food, and Rural Affairs’ (DEFRA) Voluntary Reporting Scheme (VRS) for engineered nanoscale materials, DEFRA received no new submissions since publication of the previous quarterly report in September 2007. DEFRA is in the process of updating the VRS documentation to clarify the purpose and aims of the VRS and provide supplementary guidance for anyone submitting data. DEFRA intends to publish the revised guidance in early February 2008. DEFRA will include a letter to relevant stakeholders in the industry and research communities, restating the strategic importance of the VRS.

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In a December 3, 2007, letter, to the Secretaries of Wisconsin’s Department of Natural Resources (DNR), Department of Health and Family Services (DHFS), and Department of Agriculture, Trade, and Consumer Protection (DATCP), Wisconsin State Representative Terese Berceau (D) asks for their assistance in creating a policy “to address potential environmental problems associated with the emerging field of nanotechnology.” Berceau refers to the ordinance adopted by Berkeley, California, and the U.S. Environmental Protection Agency’s (EPA) Nanoscale Materials Stewardship Program (NMSP), and proposes a reporting system and creation of a registry in Wisconsin “including addressing areas that are simply not yet fully defined in an emerging and growing technological field.” Berceau states that whether the registry is created by rule or legislation “is best determined with the guidance of the regulatory agencies dealing with similar issues today -- in public health, environmental protection, and consumer protection.”

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Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson and Ira Dassa published an article appearing in the Fall 2007 issue of Sustainable Development Law and Policy. The article discusses several issues in connection with the application of the Toxic Substances Control Act (TSCA) to engineered nanoscale materials.

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On 3 January 2008, Lloyd’s released a report entitled Nanotechnology: Recent Developments, Risks and Opportunities, which examines the potential risks and opportunities in the emerging field of nanotechnology. Lloyd’s states that nanotechnology “promises to improve many industries including medicine, food technology, textiles, materials, cosmetics, defence and more, but the risks are still not fully understood.” Continue Reading...

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On January 2, 2008, the National Nanotechnology Initiative (NNI) released its Strategic Plan, which describes NNI’s investment strategy and the program component areas called for by the 21st Century Nanotechnology Research and Development Act of 2003. Under the Act, NNI must update its Strategic Plan every three years, and this plan updates and replaces the December 2004 plan. The Strategic Plan outlines the goals and priorities of NNI and describes approaches for achieving them. NNI states that the Plan supports “leading edge research, sustains the extensive infrastructure of facilities, seeks to facilitate technology transfer, and addresses environmental, health, and societal concerns.”

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On December 19, 2007, the National Institute for Occupational Safety and Health (NIOSH) published an update entitled “NIOSH Informs, Leads Nanotechnology Actions by International Partner Organizations.” In the Update, NIOSH summarizes its recent contributions to international research:

• On November 29, 2007, the Organization for Economic Cooperation and Development’s (OECD) Working Party on Manufactured Nanomaterials agreed to establish a NIOSH-led project to: (1) exchange information on measuring and controlling exposures to nanomaterials; and (2) develop suggestions for further steps by the Working Party.
• At a December 4-7, 2007, meeting, a project group of the International Organization for Standardization (ISO) Technical Committee 229 voted to approve a draft report of safety and health practices in occupational settings relevant to nanotechnology. The draft report was based on NIOSH’s interim document entitled Approaches to Safe Nanotechnology, and was developed with NIOSH leadership and participation on the project group. 
• On December 2, 2007, NIOSH participated in a meeting of the World Health Organization’s (WHO) Global Network of Collaborating Centres in Occupational Health, focusing on nanotechnology. The objective of the meeting was to determine how the WHO collaboration can develop and support research and cooperation in preventing exposure to potentially hazardous engineered nanoparticles. NIOSH is collaborating on five communication and networking projects with various WHO centers.

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The U.S. Environmental Protection Agency’s (EPA) December 10, 2007, Unified Agenda includes a notice regarding the Nanoscale Materials Stewardship Program (NMSP), which is a voluntary program that EPA established to assemble existing data and information from manufacturers and processors of certain nanoscale materials. The notice states that, under the Toxic Substances Control Act (TSCA), EPA has the authority to require the development of data necessary for risk assessment when statutory findings concerning (1) production volume and exposure/entry into the environment or (2) potential hazard can be made, and to prevent and eliminate unreasonable risk of injury to human health and the environment. On July 12, 2007, EPA announced the availability of an NMSP concept paper, a proposed information collection request (ICR), and a paper that describes determining the TSCA Inventory status of nanoscale materials. According to the Unified Agenda notice, EPA intends to publish in February 2008 a final NMSP notice, including final versions of any documents.

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The Food and Drug Law Institute (FDLI) and the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) will hold a conference on February 28-29, 2008, on “Nanotechnology Law, Regulation and Policy.” Questions addressed during the conference will include:

• How is the Food and Drug Administration (FDA) going to implement its Nanotechnology Task Force Report?
• How is the Occupational Safety and Health Administration (OSHA) going to deal with nanotech issues in the workplace?
• Is Congress ready to act on nanotechnology if federal regulators don’t?
• What first and second generation nanotechnology products are already on the market, and what’s to come?
• Do Europe and Asia approach nanotechnology safety and oversight differently than the United States?
• When it comes to nanotechnology, should size make a regulatory difference?

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On December 12, 2007, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of the draft Current Intelligence Bulletin (CIB) entitled “Interim Guidance on Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles.” NIOSH will hold a public meeting on the draft CIB on January 30, 2008. The meeting will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public, limited only by the space available. Because the meeting room accommodates only 80 people, NIOSH must receive notification of intent to attend the meeting no later than January 18, 2008. Persons wanting to provide oral comments at the meeting are requested to notify NIOSH no later than January 11, 2008. NIOSH will give priority for attendance to those providing oral comments. NIOSH will then accommodate other requests to attend the meeting on a first-come basis. Comments on the draft CIB are due February 15, 2008. Continue Reading...

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In a recent speech at the 9th Annual Food Regulation and Labeling Standards Conference, Steve McCutcheon, CEO of Food Standards Australia New Zealand (FSANZ), said that FSANZ has begun analyzing the potential implications of nanotechnology on the food supply chain. FSANZ hopes that, by the time it receives its first application to approve the use of the technology in food, it will already have sufficient scientific and medical information to make an informed decision.

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On November 19, 2007, Environmental Defense (ED) issued a press release that states that the National Nanotechnology Initiative (NNI) is not effectively addressing the potential risks of nanotechnology, and that a potential model for resolving the conflict between NNI’s dual charges to both promote and oversee the technology could be drawn from the Atomic Energy Commission (AEC). Like the NNI, the AEC, first established in 1946, was tasked with both encouraging the development and use of nuclear power and regulating its safety. Concerns about this dual charge led Congress to abolish the AEC in 1975, and to assign its risk research and oversight functions to a new entity, the Nuclear Regulatory Commission. In the press release, ED suggests that an entity within NNI, “either newly formed or significantly elevated in status,” could be given independent budgetary and management authority, responsibility, accountability, and resources to develop and direct the overall federal nanomaterial risk research strategy.

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On November 19, 2007, the Congressional Nanotechnology Caucus held a briefing on “Nanotechnology and Environment, Health & Safety Issues.” The panel of speakers included Vicki Colvin, Ph.D., Professor of Chemistry and Chemical Engineering, Center for Biological and Environmental Nanotechnology, Rice University; Andrew Maynard, Ph.D., Chief Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars; and Pat Casano, Counsel for Environmental, Legislative, and Regulatory Affairs, General Electric. The panel discussed the environmental, health, and safety (EH&S) implications of nanotechnology.

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The European Food Safety Authority (EFSA) met the week of November 19, 2007, to begin reviewing the regulation and risk assessment of nanotechnology. The European Commission (EC) issued a mandate for a complete evaluation by March 31, 2008, but EFSA responded that, because of the range of differing properties and safety profiles, it will not be able to complete its review by this deadline. EFSA instead proposed to issue an initial scientific opinion by Summer 2008. EFSA intends to create a working group of 10 to 15 scientific experts. The Scientific Committee held its first discussion on the EFSA working strategy on November 19-20, 2007.

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On November 8, 2007, the Office of Science and Technology Policy (OSTP) and the Council on Environmental Quality (CEQ) issued a memorandum regarding “Principles for Nanotechnology Environmental, Health, and Safety Oversight.” According to the memorandum, OSTP and CEQ “led a multi-agency consensus-based process” to develop principles intended to guide the development and implementation of policies for nanotechnology environmental, health, and safety oversight at the agency level.  The memorandum says that federal agencies such as the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and the National Institute for Occupational Safety and Health (NIOSH) “must implement sound policies to protect public health and the environment,” and “agencies that perform nanotechnology research and development or that use nanotechnology in accomplishing their mission must provide appropriate oversight.” Continue Reading...

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On October 25-26, 2007, the European Commission (EC) held the First Annual Nanotechnology Safety for Success Dialogue. Presentations included:

• Food applications of nanoscience and nanotechnologies -- Ms. Sue O’Hagan, Confederation of the Food and Drink Industries of the European Union (CIAA);
• Consumer products applications of nanoscience and nanotechnologies -- Dr. Michael Holman, Lux Research;
• Health applications of nanoscience and nanotechnologies -- Dr. Carole Moquin-Pattey, European Science Foundation (ESF);
• Nanotechnology risk assessment: Knowns and unknowns -- Mr. Herman B.W.M. Koëter, Deputy Executive Director and Director of Science, European Food Safety Authority (EFSA);
• Nanoparticle toxicology: Scientific state-of-the-art -- Professor Ken Donaldson, University of Edinburgh;
• Nanomaterials. Risk assessment needs -- Professor Jim Bridges, Chair, Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR);
• The EU perspective on policy and regulatory aspects -- Mr. Kees Brekelmans; Enterprise and Industry Directorate General, “Consumer Goods” Directorate;
• Nanotechnology and the Food and Drug Administration:  Science and Policy -- Dr. Richard Canady, U.S. Food and Drug Administration (FDA); and
• The consumer perspective on applications of nanoscience and nanotechnologies -- Dr. Sue Davies, Chief Policy Advisor, Which?.

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The Swedish Chemicals Agency (KemI) recently released a report entitled Nanotechnology -- Large Risks with Tiny Particles? Although the report is in Swedish, it includes a summary in English. According to the report, the rapid development of new fields of application and a lack of knowledge call for caution. The report states that companies are responsible for ensuring that human health and the environment are not damaged and that legislation needs to be extended to cover nanomaterials. Continue Reading...

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As part of the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs’ (OPP) ongoing Nanotechnology Task Force Work, we understand that OPP is seriously considering revising the pesticide registration application form to require particle size information for both active ingredients and any inerts.

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We are pleased to announce that the Environmental Law Institute (ELI) has published the Nanotechnology Deskbook, which Lynn L. Bergeson co-authored. ELI provides the following description of the Deskbook:

Nanotechnology promises to have far reaching impacts on the economy, including offering technological advances in pollution control. While over 200 products that use nanomaterials are already in the marketplace, minimal data exist on the health and environmental effects of nanomaterials. This poses significant questions for companies, regulators, consumers, and lawyers.

The Nanotechnology Deskbook guides the reader through the application of existing law and regulations to nanomaterials by exploring domestic laws and regulations and considering developments in the international context. It includes a focus on special business considerations when this technology is involved and concludes by discussing the development of an effective environmental governance structure for nanotechnologies that protects human health and the environment without stifling the development of this new field.

The Nanotechnology Deskbook may be purchased on the ELI website

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On October 31, 2007, the House Committee on Science and Technology’s Research and Science Education Subcommittee held a hearing on the relationship between environmental and health policy and nanotechnology. The Subcommittee examined how the U.S. can stay at the forefront of scientific research and development, while at the same time establishing priorities and a detailed plan for research on the potential environmental and health risks of engineered nanomaterials. The Science and Technology Committee held two previous hearings on this issue -- one in 2005 and another in 2006 -- with the objective of reviewing the importance of risk research for achieving the potential benefits of nanotechnology and the efforts of the interagency National Nanotechnology Initiative (NNI) to put in place a research strategy. Progress in developing the research strategy has been slow, however. The hearing explored the status of the planning efforts and received suggestions from outside witnesses on ways to improve the process. Continue Reading...

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On October 25, 2007, the Agency for Toxic Substances and Disease Registry (ATSDR) requested nominations from a list of proposed substances that it will evaluate for toxicological profile development. The list of proposed substances includes nanomaterials. According to the notice, ATSDR will evaluate all data and information associated with the nominated substances and will determine the final list of substances to be chosen for toxicological profile development. Comments are due November 26, 2007.

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Last week, the U.S. Environmental Protection Agency (EPA) placed in the docket a report summarizing remarks and public comments made during the August 2, 2007, meeting on the Nanoscale Materials Stewardship Program (NMSP). The purpose of the meeting was to discuss and receive comments on the development of the voluntary NMSP. The intent of the report is to provide an overview of the discussion that occurred. It does not analyze or evaluate any portion of the discussions. EPA structured the meeting agenda to allow formal comments from eight, pre-registered stakeholders, and allocated time in the afternoon to allow additional stakeholders who requested time to speak to make public comments.  The meeting concluded with a question and answer session focusing on key issues that were specifically identified by EPA.  The meeting brought together 124 participants, including stakeholders in academia, non-governmental organizations (NGO), government, industry, professional organizations, the press, international entities, and the general public.  Meeting minutes were not prepared and a transcript was not recorded.

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According to the fourth quarterly report for the UK’s Voluntary Reporting Scheme (VRS) for Manufactured Nanomaterials, the Department for Environment, Food, and Rural Affairs (DEFRA) received no new submissions during the most recent quarter. Since the VRS began in September 2006, DEFRA has received a total of nine submissions, seven from industry and two from academia. In late July 2007, the Advisory Committee on Hazardous Substances (ACHS) reported the findings of its review of the VRS. ACHS concluded that improvements to the VRS guidance documents were needed to increase participation levels and enhance the quality and relevance of data submitted. ACHS recommended changes to the scheme literature to make its purpose clearer and make the specific data requested from industry more explicit. The report states that DEFRA will publish revised guidance shortly. The VRS is scheduled to end in September 2008, at which time DEFRA will evaluate its success and consider alternatives, including compulsory data submissions, if necessary.

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The Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars hosted on October 9, 2007, a seminar on the Responsible NanoCode, a voluntary, principles-based Code of Conduct for entities involved in the research, development, manufacture, and retail sale of products using nanotechnologies. The draft Code was developed by a working group organized in late 2006 by The Royal Society, the United Kingdom’s (UK) national academy of science, in conjunction with Insight Investment, the Nanotechnology Industries Association (NIA), and the UK government-sponsored Nanotechnology Knowledge Transfer Network.

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On October 3, 2007, the California Department for Toxic Substances Control (DTSC) held a symposium on the potential hazards of nanoparticles in the environment. According to DTSC, exploring environmentally safe processes in nanotechnology manufacturing is a component of the California Green Chemistry Initiative.  Under the Initiative, a multi-agency state team is exploring a different approach to environmental protection -- transitioning away from managing toxic chemicals at the end of the life-cycle, to reducing or eliminating their use altogether.  DTSC states that this new approach is similar to measures adopted by the European Union (EU) and the Canadian government to encourage greater manufacturer responsibility. Continue Reading...

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Environment Canada (EC) and Health Canada (HC) have released a document entitled Proposed Regulatory Framework for Nanomaterials Under the Canadian Environmental Protection Act, 1999 (Proposed Framework). EC/HC will hold a public workshop for stakeholders regarding the Proposed Framework on September 27, 2007, in Toronto. At the workshop, EC/HC will gather comments from participating stakeholders through discussion groups and plenary sessions. EC/HC will invite all stakeholders to provide additional written comments the weeks following the meeting. Click here to request a copy of Bergeson & Campbell, P.C.’s memorandum on the Proposed Framework.

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On August 30, 2007, Greenpeace International (Greenpeace) issued a report entitled Navigating REACH: An Activists’ Guide To Using and Improving the New EU Chemicals Legislation (Guide), which is intended to explain how the European Union’s (EU) Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation will work, what main issues are at stake, and how the law will be implemented. The Guide highlights provisions that non-governmental organizations (NGO) and citizens can use to promote safer chemicals and lead ultimately to better protection of human health and the environment from the adverse impact of hazardous chemicals. The Guide includes nanomaterials among the issues for NGOs: Continue Reading...

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On August 27, 2007, the Antitrust Division of the Department of Justice (DOJ) published a notice in the Federal Register announcing that, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. Sections 4301 et seq., the Nanoparticle Flow Processing Consortium has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission (FTC) disclosing (1) the identities of the parties to the venture and (2) the nature and objectives of the venture. The notice states that the Consortium filed the notifications for the purpose of invoking the Act’s provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Pursuant to Section 6(b) of the Act, the identities of the parties to the venture are: 3M Company, St. Paul, Minnesota; The Proctor & Gamble Company, Cincinnati, Ohio; Corning Incorporated, Corning, New York; BASF Aktiengesellschaft, Ludwigshafen, Germany; and Imperial Chemical Industries PLC, London, United Kingdom. The general area of the Consortium’s planned activity is to: (1) develop, test, and validate computer-simulation technologies of near-term application that can improve the quality and reduce the cost of nanoparticle suspension/dispersion manufacture (including suspension stability and processibility); (2) transfer the technology developed under the Research and Development Program in a manner that offers the Consortium members opportunities for commercial advantage; and (3) develop methodologies and aptitude for modeling and simulation of multiscale phenomena intrinsic to the stability and dynamics of dense, nanoparticle suspensions.

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The European Commission (EC) Directorate General for Health and Consumer Protection retained GreenFacts to summarize the EC’s 2006 report entitled Modified Opinion (After Public Consultation) on the Appropriateness of Existing Methodologies to Assess the Potential Risks Associated with Engineered and Adventitious Products of Nanotechnologies. According to GreenFacts, the EC’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) wrote its Opinion for a scientific audience. GreenFacts prepared its summary for a broader audience. Continue Reading...

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Yesterday the Food and Drug Administration (FDA) released a proposed rule that would amend the final monograph for over-the-counter (OTC) sunscreen drug products as part of FDA’s ongoing review of OTC drug products. The proposed rule addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, would introduce four-star rating system for the level of UVA protection, and would require a warning statement. FDA previously delayed regulations concerning UVA protection until reliable testing methodologies could be developed. The proposed rule specifically solicits comment on “the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.”  Comments on the proposed avobenzone combinations will be due 60 days after publication of the Federal Register notice. Comments on all other parts of the proposed rule and on FDA’s economic impact determination will be due 90 days after publication in the Federal Register. Continue Reading...

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The California Department of Toxic Substances Control (CDTSC) will hold a symposium entitled “Nanotechnology Symposium II:  Potential Hazards of Nanomaterials in the Environment” on October 3, 2007. The draft agenda includes the following topics: 

• Chemical Properties and Commercial/Industrial Applications of Nanotechnology;
• Physico-Chemical Characterization of Nanoparticles and Its Relation to Their Bio-Interactions;
• Potential Ecotoxicity of Nanoparticles Released to the Environment;
• Nanomaterial Human Health Risks and Risk Assessment; and
• One Proactive Approach to Responsible Nanotechnology Development:  The DuPont -- Environmental Defense NanoRisk Framework.

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On August 16, 2007, 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), published a notice in the Federal Register announcing the availability of a document entitled The Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment, which assigns priority to research needs and areas identified in the NSET Subcommittee document Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, which was published on September 21, 2006.  Comments are due September 17, 2007. Continue Reading...

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The National Institute for Occupational Safety and Health (NIOSH) has posted several material safety data sheets (MSDS) for nanomaterials in its Nanoparticle Information Library (NIL). The goal of the NIL is to help occupational health professionals, industrial users, worker groups, and researchers organize and share information on nanomaterials, including their health and safety-associated properties.  To view the MSDSs, enter msds in the search field.

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On August 8, 2007, the European Commission (EC) released the scientific opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the appropriateness of the risk assessment methodology in accordance with the European Union’s (EU) technical guidance documents for new and existing substances for assessing the risks of nanomaterials. SCENIHR concluded that modifications to the existing technical guidance documents are necessary because special characterization of nanomaterial properties, which potentially differ considerably from conventional chemicals, is needed. Furthermore, the toxicological behavior and effects on health and the environment need to be assessed properly.  The opinion states that, due to the lack of common rules for the toxicology of nanomaterials, the risk assessment of nanomaterials should be done on a case-by-case basis. SCENIHR identified issues requiring improvements in the technical guidance and methodologies, and proposed a staged strategy for the risk assessment of nanomaterials. Special consideration is required for the assessment of the potential translocation of nanoparticles in humans and other species, and potential adverse effects, for example, within the cardiovascular system or following passage across the blood-brain barrier.

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On July 31, 2007, an international coalition of consumer, public health, environmental, and labor organizations issued the Principles for the Oversight of Nanotechnologies and Nanomaterials and called for strong, comprehensive oversight of the new technology and its products. According to the coalition, the manufacture of products using technology has “exploded in recent years,” while “evidence indicates that current nanomaterials may pose significant health, safety, and environmental hazards.” Continue Reading...

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On August 2, 2007, the U.S. Environmental Protection Agency (EPA) convened a public meeting on the Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA). The meeting, which EPA had announced in a July 12, 2007, Federal Register notice, was well attended, with approximately 100 people in attendance. After introductory remarks by several EPA officials, various organizations presented their views on the NMSP and the associated draft documents made available by EPA on July 12, 2007. Among those offering comments were the American Chemistry Council (ACC) Nanotechnology Panel, Environmental Defense (ED), Consumers Union, the NanoBusiness Alliance, the International Council on Nanotechnology, and Dr. J. Clarence Davies of the Project on Emerging Nanotechnologies (PEN).

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On July 31, 2007, Representative Mike Honda (D-CA) introduced the Nanotechnology Advancement and New Opportunities (NANO) Act (HR 3235), which is intended to promote the development and responsible stewardship of nanotechnology in the U.S. Honda based the legislation on the recommendations of the Blue Ribbon Task Force on Nanotechnology, a panel of California nanotechnology experts with backgrounds in established industry, startup companies, consulting groups, non-profits, academia, government, medical research, and venture capital convened by Honda and then-California State Controller Steve Westly during 2005. Continue Reading...

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According to a recent survey presented at the Rural Futures conference in Canberra, Australia, nanotechnology in food and farming is inadequately regulated. Rural sociologist Dr. Kristin Lyons, Griffith University, stated: “Despite significant investment from the agrifood sector in nanotechnologies, the need for nano-specific regulation in this area hasn’t been recognised as a priority by the federal government.” Lyons said that the nano-agrifood industry will be worth more than US $20 billion by 2010.

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The proceedings of the June 19-21, 2007, EuroNanoForum 2007 are available. According to the European Commission (EC), they “provide an overview of the state-of-the-art in nanotechnology for industrial applications, presented by selected international top speakers to open up new perspectives in Europe for coming years.”

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On July 23, 2007, the United Kingdom (UK) Royal Society issued a press release entitled “’Responsible NanoCode’ for business to be developed.” The press release states: “An initiative to develop a ‘Responsible NanoCode' for businesses working with nanotechnologies has been launched by the Royal Society, Insight Investment, the Nanotechnology Industries Association and the Nanotechnology Knowledge Transfer Network today.” The Code is intended to establish a set of internationally relevant principles that outline good practice for businesses involved in all aspects of these emerging technologies and their applications including research, development, manufacturing, distribution, and retailing. An open consultation will take place in Autumn 2007 when a draft code will be available for comment.  The working group aims to publish the Code early in 2008.

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On July 25, 2007, the Food and Drug Administration (FDA) Nanotechnology Task Force issued its report, which addresses regulatory and scientific issues and offers recommendations for each. The Task Force intends its report to outline ways for FDA to enhance its knowledge of nanotechnology to support its oversight for products using such technology, and to inform interested stakeholders what information may be needed to support the marketing of FDA-regulated products that use nanoscale materials. The Task Force recommends FDA consider developing specific guidance for manufacturers and researchers, including guidance to clarify what information should be provided to FDA about products and when the use of nanoscale materials may change the regulatory status of particular products. In its press release announcing the availability of the Task Force report, FDA states that, as with other FDA guidance, “draft guidance documents would be made available for public comment prior to being finalized.” The Task Force also recommends that FDA work to assess data needs to better regulate nanotechnology products; develop in-house expertise; ensure consideration of relevant new information on nanotechnology as it becomes available; and evaluate the adequacy of current testing approaches to assess safety, effectiveness, and quality of nanoscale materials.

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Environment Canada (EC) recently posted a New Substances Program Advisory Note entitled “Requirements for nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers).” The Advisory Note was signed in June 2007 and states that the Canadian Environmental Protection Act, 1999 (CEPA) and the New Substances Notification Regulations (Chemicals and Polymers) (Regulations) “apply to new nanomaterials just as any other substance, whether a chemical or a polymer. Continue Reading...

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The Council of State and Territorial Epidemiologists (CSTE) recently issued a position statement on nanotechnology risks. The CSTE statement observes that the “health, safety and environmental effects of nanomaterials are poorly understood,” and that “our limited knowledge of [nanotechnology’s] potential harm is cause for concern.” Among other things, CSTE calls: for increased funding for research on the environmental, health, and safety impacts of nanotechnology; for the Food and Drug Administration (FDA) to require content-labeling on products containing nanoparticles that are aerosolized or applied to the skin; and for the U.S. Environmental Protection Agency (EPA) and Occupational Safety and Health Administration (OSHA) to issue standards for the protection of workers, the public, and the environment against known or suspected harmful effects of nanoparticles.

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On June 9, 2007, the U.S. Environmental Protection Agency (EPA) signed three Federal Register notices related to the Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA) (appended). EPA intends to publish the notices in the July 12, 2007, Federal Register. The first notice announces a public meeting on August 2, 2007, to receive comments on the development of the voluntary NMSP. The second notice announces the availability of two draft documents for public review and comment: (1) “Concept Paper for the Nanoscale Materials Stewardship Program under TSCA” (Concept Paper); and (2) “TSCA Inventory Status of Nanoscale Substances -- General Approach” (TSCA Inventory Paper). The third notice solicits public comments on specific aspects of the proposed information collection request (ICR) for the voluntary NMSP. According to EPA, the purpose of the August 2, 2007, public meeting, which will occur during the comment period on the draft documents, is to further discussion and development of the NMSP. Registration for the meeting will be open until July 30, 2007, but is not necessary to attend the meeting. Registration will be available through the NMSP website at http://www.epa.gov/oppt/nano. Requests to make oral comments at the meeting are due July 30, 2007. Continue Reading...

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Until September 6, 2007, the European Commission (EC) Scientific Committee on Consumer Products (SCCP) is accepting comments on its Preliminary Opinion on the Safety of Nanomaterials in Cosmetic Products. According to the SCCP, traditional risk assessment methods -- hazard identification, hazard characterization, and exposure assessment -- may not be suitable for nanomaterials in cosmetics.  The SCCP suggests that either a new method should be developed, or the existing methodologies for hazard characterization and exposure assessment should be validated.  The SCCP recommends that the risk assessment of nanoparticles in cosmetics should be carried out on a case-by-case basis, taking into account the specific physical, chemical, and surface area characteristics of nanomaterials.  Previous safety evaluations on nanomaterials used in cosmetics would also need to be revised.

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In the July 2, 2007, Federal Register, the U.S. Environmental Protection Agency (EPA) published a notice regarding its conference entitled “Pollution Prevention through Nanotechnology,” which will be held on September 25-26, 2007, in Arlington, Virginia. EPA intends the conference to provide a forum to exchange ideas and information on using nanotechnology to develop new ways to prevent pollution. Lynn L. Bergeson is on the Steering Committee for the conference. Representatives from industry, academia, non-governmental organizations, and government are invited to focus on current practices and potential research areas in nanotechnology that incorporate the concept of pollution prevention in three major areas:

• Products: Less toxic, less polluting, and wear-resistant.
• Processes: More efficient and waste-reducing.
• Energy and Resource Efficiency: Processes and products that use less energy and fewer raw materials because of greater efficiency.

Registration is open until September 14, 2007, but is not required to attend the conference. Continue Reading...

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The American Bar Association’s (ABA) Section of Environment, Energy, and Resources (SEER) held its latest Nanotechnology Teleconference on June 21, 2007. Entitled “Nanotechnology and Environmental Governance,” the teleconference explored the need for voluntary environmental governance mechanisms to augment the U.S. Environmental Protection Agency’s traditional regulatory programs to manage the issues associated with nanotechnology. The teleconference featured three speakers: Allyson Hartzell, Managing Scientist, Exponent Failure Analyst Associates; Kevin J. Fay, Director, Product & Supply Chain Stewardship, PPG Industries, Inc.; and Linda K. Breggin, Senior Attorney, Environmental Law Institute.

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On June 21, 2007, Environmental Defense (ED) and DuPont, who commenced a partnership on nanotechnology in September 2005, released the final Nano Risk Framework, which establishes “a systematic and disciplined process for identifying, managing, and reducing potential environmental, health, and safety risks of engineered nanomaterials across all stages of a product’s ‘lifecycle.’” The Framework is aimed primarily at organizations, both private and public, that are actively working with nanomaterials and developing associated products and applications. ED and DuPont believe that “adoption of the Frameworkcan promote responsible development of nanotechnology products, facilitate public acceptance, and support the formulation of a practical model for reasonable government policy on nanotechnology safety.”

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On June 4, 2007, the Food and Drug Administration (FDA) announced a new advisory committee intended to counsel FDA on how to strengthen the communication of risks and benefits of FDA-regulated products to the public. The Risk Communication Advisory Committee will:

• Help FDA better understand the communication needs and priorities of the general public;
• Advise FDA on the development of strategic plans to communicate product risks and benefits; and
• Make recommendations to FDA on what current research suggests about crafting risk and benefit messages, as well as how to most effectively communicate specific product information to vulnerable audiences.

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On June 18, 2007, the Congressional Nanotechnology Caucus will host a briefing on Nanotechnology Applications for Renewable Energy. On July 16, 2007, the Caucus will host a briefing on Nanotechnology Applications for Energy Conservation. Each event will begin at 2 p.m. (EDT). The purpose of the Congressional Nanotechnology Caucus is to promote nanotechnology, educate policy makers about this emerging area, and facilitate communications between industrial and academic researchers and the Hill.

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The July 2007 issue of Regulatory Toxicology and Pharmacology includes an article entitled “Limits and Prospects of the ‘Incremental Approach’ and the European Legislation on the Management of Risks Related to Nanomaterials.” According to the authors, the European Commission (EC) has adopted an incremental approach, focusing on adopting existing laws to regulate nanotechnologies. The authors concluded that the current regulations fail to address the environmental, health, and safety risks posed by nanomaterials and recommended specific revisions to European regulatory policies and the information on which they are based.

Continue Reading...

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On April 24, 2007, the Kojo Nnamdi Show, a news magazine program on National Public Radio (NPR), aired a program entitled “New Approaches to Nanotechnology.” The program featured: David Rejeski, Director, Project on Emerging Nanotechnologies (PEN), Woodrow Wilson International Center for Scholars/Pew Charitable Trusts; Rick Weiss, Science and Medicine Reporter, The Washington Post; Jeffrey Schloss, Co-Chair, Trans-National Institutes of Health (NIH) Nano Taskforce, NIH; and Nora Savage, Environmental Engineer, Office of Research and Development (ORD), U.S. Environmental Protection Agency (EPA).

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The July 2007 issue of Consumer Reports includes an article entitled “NANOtechnology: Untold Promise, Untold Risk.” According to Consumer Reports, while nanotechnology “promises to be the most important innovation since electricity and the internal combustion engine,” “some applications might pose substantial risks to human health and the environment.” The article states that nanomaterials are already being used in consumer products such as car wax, computer chips, and sunscreen, and that approximately $2.6 trillion worth of goods worldwide are expected to use nanotechnology by 2014, up from $50 billion in 2006. Consumers Union (CU), the nonprofit publisher of Consumer Reports, concludes that the responsibility for protecting consumers rests mainly with government and industry.  In particular, CU believes that the government should provide more funds for risk research and regulation, and that the Food and Drug Administration (FDA) should assess safety information on nanoingredients in cosmetics, food additives, and other products before they are sold, and should require manufacturers to report health problems linked with those ingredients. The full article is available in the July 2007 issue of Consumer Reports.

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On May 30, 2007, the Canadian Institute for Environmental Law and Policy (CIELAP) released a document entitled Discussion Paper on a Policy Framework for Nanotechnology, which builds on policy issues discussed at a March 16, 2007, workshop. CIELAP states that it supports a goal statement and context for nanotechnology policy that is centered on an explicit recognition and endorsement of sustainable development.  According to CIELAP, the policy challenges for nanotechnology are enormous, and currently are dominated by a lack of scientific information and basic policy tools, including definitions and metrology; a legal and regulatory framework; and structures and resources for public engagement.  CIELAP notes that, despite these gaps, however, many parallels with other issues and institutional arrangements exist, and could be adapted for nanotechnology.  Due to nanotechnology’s extraordinarily rapid commercialization and development, speed and a strong sense of urgency are needed by government for a responsible Canadian approach to the creation of policy for this area. Continue Reading...

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On May 23, 2007, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled EPA and Nanotechnology: Oversight for the 21st Century, which identifies actions that should be taken to establish an oversight system. The report focuses in particular on the U.S. Environmental Protection Agency (EPA), which it describes as “a key agency in any oversight effort because of its numerous regulatory authorities and its mission to protect the environment and human health.” According to the report, a review of existing EPA authorities reveals a number of weaknesses. In particular, the report states that the Toxic Substances Control Act (TSCA), “which is the only law potentially capable of providing general oversight for nanotechnology, is extremely deficient in many respects and needs to be amended.” Moving beyond TSCA, the report states further that “virtually every authority that EPA has at its disposal has weaknesses in terms of nanotechnology oversight.” The report discusses tools that will need to be combined in an oversight system, including information tools, voluntary efforts, economic tools, and liability. The report also discusses the role of state and local governments, and public participation, and outlines nine different examples of the ways the tools could be used. The report concludes with an action agenda containing more than 25 actions necessary to improve the oversight of nanotechnologies.

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According to a recent report entitled Nanomaterials in Consumer Products, the extent to which a variety of European regulations would manage potential risks of nanomaterials in consumer products cannot be assessed. The report was prepared for the European Parliament’s Committee on the Environment, Public Health, and Food Safety. According to the report, which is not publicly available, “[u]ntil there are data on which to determine the nature of any risks posed by nanomaterials, it is not possible to assess the full extent to which the implementation of current regulations addresses any potential risks.”  The report makes recommendations about policies that could be used if it is determined that existing European laws are inadequate.

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On May 15, 2007, the Natural Resources Defense Council (NRDC) issued a report entitled Nanotechnology’s Invisible Threat: Small Science, Big Consequences, which claims that the U.S. government has failed “to use its authority to protect citizens from the potentially dangerous effects of nano-scale chemistry.” Continue Reading...

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It has been suggested by some that REACH’s application to nanoparticles and nanomaterials is unclear.  While it is true that REACH does not specifically mention nanoparticles or nanoscale materials anywhere in its 800+ pages of text, we note that in December 2006, shortly after the regulation’s adoption by the European Parliament, the European Commission posted on its website a question-and-answer document that includes the following two exchanges: Continue Reading...

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At the 2007 U.S.-European Union (EU) Summit in Washington, D.C. late last month, President Bush and European Union (EU) leaders signed an economic integration agreement, the Framework for Advancing Transatlantic Economic Integration Between the United States of America and the European Union.

Continue Reading...

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On May 10, 2007, the European Commission (EC) announced the availability of the results of its April 16, 2007, workshop on intellectual property rights (IPR) in nanotechnology. The objective of the workshop was to identify specific IPR issues for nanotechnology and to discuss possible consequences for patent offices, policy makers, patent consultants, and the research community.  Ongoing academic and political discussions have identified many aspects, such as the costs of patenting and the accessibility of patents for small- and medium-sized enterprises (SME) or developing countries; the need for a transparent and clearly defined scope of patent protection; the implications of “nanopatent land grab” and “patent thickets”; “nanotech patent battles”; and “second nature” and “monopoly patent.”  The discussions were aiming at possible actions specific for nanotechnology, i.e., the need for a better patent monitoring system of nanotechnology for patent application and examining, technology analysis, and policy advice purposes, the possible need for harmonization between the European Union (EU), the U.S., and Japan, the need for a new nanotechnology patent regime, the development of guidelines for the protection of IPR and models for consortium and licensing agreements, lessons for collaborative research projects, and other research collaborations.

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Environmental Defense (ED) will hold a webcast regarding its recent report, Not That Innocent: A Comparative Analysis of Canadian, European Union and United States Policies on Industrial Chemicals, on May 24, 2007, from 3:00 p.m. to 4:30 p.m. (EDT). The webcast will include a 45-minute presentation and a question and answer period. Dr. Richard Denison, Senior Scientist at ED, will present the findings and discuss his report, which compares the European Union’s new Registration, Evaluation, and Authorization of Chemicals (REACH) regulation, the Toxic Substances Control Act (TSCA), and the Canadian Environmental Protection Act (CEPA). Continue Reading...

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The Toxics Management Division (TMD) in the City of Berkeley’s Planning and Development Department has issued guidance on the nanoparticle municipal ordinance that the Berkeley City Council adopted on December 12, 2006. Under the ordinance, facilities that manufacture or use “manufactured nanoparticles” must submit to the TMD “a separate written disclosure of the current toxicology of the materials reported, to the extent known, and how the facility will safely handle, monitor, contain, dispose, track inventory, prevent releases and mitigate such materials.” The term “manufactured nanoparticles” is defined to mean particles “with one axis less than 100 nanometers in length.” The TMD guidance makes clear that facility reports covering the period June 1, 2007 -- June 2, 2008, are due by June 1, 2007, and must include, among other things, toxicological and ecological information about the nanoscale material and information about the potential exposure pathways and likelihood of exposure via those pathways.

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On April 30, 2007, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its latest Semiannual Regulatory Agenda, which serves to update the public on regulations and major policies currently under development by EPA.  One of the entries in the Toxic Substances Control Act (TSCA ) portion of the agenda is entitled "Nanoscale Materials Under TSCA" and addresses the forthcoming Nanoscale Materials Stewardship Program (NMSP), the design of which EPA publicly announced in October 2006.  The agenda entry estimates that drafts of various documents -- "a document that describes the specific elements of the voluntary [NMSP]," "an updated document that describes the approach to nanoscale materials under TSCA and a paper that describes determining the inventory status of nanoscale materials" -- will be made available sometime this month.  While we recognize that the Regulatory Agenda is often quite inaccurate in terms of forecasting, we did not want this brief update to go overlooked.  The NMSP documents are currently undergoing inter-agency review.

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On April 16, 2007, the U.S. Environmental Protection Agency (EPA) announced that, due to a technical problem, it is unable to verify receipt of contact information from anyone who subscribed to the e-mail notification list on the Office of Pollution Prevention and Toxics (OPPT) Nanotechnology web page from October 18 to November 1, 2006, and again from January 18 to January 23, 2007.  According to EPA, it has corrected the problem and is now compiling a list of stakeholders to contact as the Nanoscale Materials Stewardship Program moves forward.  EPA requests that anyone who subscribed to the e-mail notification during these periods do so again.

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On April 11, 2007, the European Commission (EC) announced that the report prepared by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) regarding the appropriateness of the risk assessment methodology for assessing the risks of nanomaterials is available for comment. Comments are due May 23, 2007. EC states that the report “provides the Commission with a sound scientific approach on how to modify the Technical Guidance Documents of the EU chemicals legislation in regard to nanomaterials. The report provides proposals for general and specific modifications of risk assessment of human health and the environment, describes a staged strategy for the risk assessment of nanomaterials and identifies areas of further research.”

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On April 3, 2007, the United Kingdom’s (UK) Department of Environment, Food, and Rural Affairs (DEFRA) released its second quarterly update on the Voluntary Reporting Scheme (VRS) for engineered nanoscale materials. According to the update, DEFRA has received a total of six submissions since VRS’s launch in September 2006, four of which were from industry and two from academia. DEFRA has liaised with groups representing the UK nanotechnologies industry and has made direct contact with companies involved in the sector. From these contacts, DEFRA believes that “a number of VRS submissions are being prepared and will be delivered” in the near future. During discussions with industry, DEFRA sought feedback on VRS, and industry raised the following issues: uncertainty regarding the scope of VRS; resources; and confidentiality issues. The next update will be published in June 2007.

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The International Council on Nanotechnology (ICON) and Rice University’s Center for Biological and Environmental Nanotechnology (CBEN) announced on March 22, 2007, they have launched a monthly online journal that contains citations and links to articles on the environment and health impacts of nanotechnology. The ICON and CBEN coalition launched the first online database of nanomaterial scientific findings in August 2005, but the new journal -- The Virtual Journal of Nanotechnology Environment, Health & Safety (VJ-Nano EHS) -- “has taken the concept one step further,” the coalition said. The virtual journal organizes the information contained in the existing database into a reader-friendly monthly journal format. New features include a rotating guest editorship and a series of papers on topics of interest taken from the database. Contents of the journal are searchable. In the future, the coalition said, the journal will include a section on the most cited nanotechnology environment, health, and safety papers.

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At the 2007 GlobalChem Conference in Baltimore, Maryland, Lynn L. Bergeson presented slides on “Nanotechnology:  What’s New.”  Bergeson & Campbell, P.C. co-sponsored this important conference.

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On March 20, 2007, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Nanotechnology and Life Cycle Assessment: A Systems Approach to Nanotechnology and the Environment, which summarizes the results of the October 2-3, 2006, workshop organized by PEN and the European Commission on life cycle assessment (LCA). LCA is a cradle-to-grave analysis of how a material affects ecosystems and human health. According to the report, the purpose of the October 2-3, 2006, workshop was to determine whether existing LCA tools and methods are adequate to use on a new technology. The report provides an overview of LCA and nanotechnology, discusses the current state of the art, identifies current knowledge gaps that may prevent the proper application of LCA in this field, and offers recommendations on the application of LCA for assessing the potential environmental impacts of nanotechnology, nanomaterials, and nanoproducts. Continue Reading...

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In a March 15, 2007, letter, the Senate Committee on Commerce, Science, and Transportation and the Congressional Nanotechnology Caucus requested that the Government Accountability Office (GAO) review the National Nanotechnology Initiative (NNI), which was created to accelerate the discovery, development, and deployment of nanoscale science and technology. For fiscal year 2006, NNI received $1.2 billion in research and development funding, and 22 federal agencies, including the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC), and the Occupational Safety and Health Administration (OSHA), participate in NNI. According to the letter, one key expectation for NNI was “to ensure that adequate attention and research funding was made available to gain a better understanding of the potential environmental, health, and safety (EHS) risks associated with nanomaterials.” The letter states that the Committee and Caucus “are extremely concerned that this has not happened and that there is a lack of transparency with regard to how much federal attention and funding this important aspect of the initiative is receiving.” Continue Reading...

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