PEN and GMA Review Regulatory Process for Nanomaterials in Food Packaging

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.

Lynn L. Bergeson Will Participate in NSTI Nanotech 2008 Conference

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.”

DEFRA Posts Sixth Quarterly Report on the Voluntary Reporting Scheme

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.

EPA Seeks Participants for In-Depth Portion of NMSP

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.

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EPA Unified Agenda Includes Item on Nanoscale Materials Stewardship Program

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.

ICTA-Led Coalition Petitions for FIFRA Regulation of Nanoscale Silver Products

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.

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GAO Testifies Before Senate Subcommittee on the Accuracy of Data Concerning Federally Funded EHS Research

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.

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Senate Committee Will Hold NNI Reauthorization Hearing

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

German Chemical Industry Association Releases Nanomaterials Product Stewardship Document

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

PEN Report Finds States Could Prompt Federal Action Regarding Nanotechnology

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.”

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SVTC Calls for Increased Regulation of Nanomaterials

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.

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NIOSH Seeks Participants for Field Research and for Metal Oxides Study

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.

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CNSI Will Hold Legislative Summit on Nanotechnology

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.”

DuPont and ED Will Hold Nano Risk Management Training Workshops

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.

DEFRA Releases Updated VRS Guidance

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.”

PTO Will Hold Nanotechnology Customer Partnership Meeting in April 2008

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.

FOE Releases Report on Nanotechnology in Food and Agriculture

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.

EC Will Hold Workshop on Research on the Safety of Nanomaterials

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.

NIOSH Seeks Comment on Strategic Plan for Nanotechnology Research

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.

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EPA Will Hold Meeting on Industry-Government Partnerships

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.

SCCP Releases Opinion on Safety of Nanomaterials in Cosmetic Products

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.

EC Announces Increases in Industrial Research in Nanoelectronics

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.

PEN Brief Reviews Applicability of TRI to Nanomaterials

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.

EC Asks for Scientific Opinion on Risk Assessment of Products of Nanotechnologies

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.

NSET Releases Strategy for Nanotechnology-Related EHS Research

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.”

EPA Releases Draft Nanomaterial Research Strategy

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.

European Commission Adopts Code of Conduct for Responsible Nanosciences and Nanotechnologies Research

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.

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EFSA Calls for Data on Applications of Nanotechnology and Nanomaterials Used in Food and Feed

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.

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CRS Report Reviews Possible Risk Management Approaches for Congress to Consider

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.

EPA Announces Voluntary NMSP

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.

Danish Report Finds Nanotechnology Covered by Existing Legislation

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.

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DEFRA Posts Fifth Quarterly Report on the Voluntary Reporting Scheme

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.

Good Governance: Evolution of the Nanoscale Materials Stewardship Program

Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson published an article appearing in the Winter 2007 issue of Nanotechnology Law & Business. The article discusses the U.S. Environmental Protection Agency's voluntary Nanoscale Materials Stewardship Program (NMSP) and related issues.

Wisconsin Representative Requests Assistance in Creating Registry

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.”

TSCA and Engineered Nanoscale Substances

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.

Lloyd's Releases Report Examining Risks And Opportunities

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.”

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NNI Releases Strategic Plan

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.”

NIOSH Summarizes Recent International Activities

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