Nano and Other Emerging Chemical Technologies Law Blog: Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotech and Chemical Legal Developments

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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On December 19, 2007, the Department for Environment, Food and Rural Affairs (DEFRA) published a report entitled Characterising the Potential Risks Posed by Engineered Nanoparticles: A Second UK Government Research Report, which follows up on DEFRA’s 2005 report and 2006 progress report. The report reviews the status of research pertaining to the environmental, health, and safety (EHS) issues relating to engineered nanoparticles, and places the United Kingdom’s (UK) research program in an international context. DEFRA is collaborating with international partners, particularly the Organization for Economic Cooperation and Development (OECD) and the International Standards Organization (ISO), to share data and experiences. In this way, according to the report, DEFRA will be able to maximize the effectiveness and speed with which potential risks may be identified and managed.

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On December 18, 2007, the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars hosted a seminar, Nanotechnology & the Media: The Inside Story, to mark the release of a new PEN study on mass media coverage of nanotechnology risks. Conducted by Professor Sharon M. Friedman and Brenda P. Egolf of Lehigh University, the study identified a sizable increase in 2006 over previous years in the number of stories appearing in American and British newspapers and wire services on nanotechnology risks. The study also showed a surge in the number of articles addressing government regulation of nano and a simultaneous decrease in media reports focused on scientific issues (e.g., nano-related study/research results).

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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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On December 4, 2007, the Organization for Economic Cooperation and Development (OECD) posted a notice entitled “Testing a Representative Set of Nanomaterials -- The Launch of a Sponsorship Programme.” OECD states that its Working Party on Manufactured Nanomaterials has launched a sponsorship program in which countries will share the testing of specific nanomaterials. According to OECD, valuable information on the safety of manufactured nanomaterials can be derived by testing a representative set for human health and environmental safety. In launching the sponsorship program, the Working Party agreed to a priority list of manufactured nanomaterials for testing, based on materials which are in or close to commerce, as well as a list of endpoints for which they should be tested. OECD intends to make regular updates on this program.

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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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