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

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 19, 2007, the European Commission (EC) issued a press release entitled “Commission launches consultation on responsible research in Nanosciences and Nanotechnologies.” The press release states: “The European Commission has today announced a public consultation on responsible nanosciences and nanotechnologies research.  The consultation will provide input for a Recommendation to the Member States on a possible Code of Conduct for this emerging area of science, which the Commission will put forward later this year.  Contributions are expected from a broad cross-section of European society, including the scientific community, industry, civil society, policy-makers, media and the general public.”

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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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On June 22, 2007, the U.S. Environmental Protection Agency (EPA) announced the award of two research grants totaling almost $600,000 to scientists at Oregon State University, who will evaluate whether some engineered nanomaterials adversely affect human health. Under the first research grant, scientists will review a variety of commonly manufactured nanomaterials to determine their potential interactions with biological processes; if the researchers find nanomaterials that produce adverse human health effects, they will seek to identify the potential cellular and genetic targets of those nanomaterials and group the nanomaterials by composition and effects. The second research grant will focus on how engineered nanomaterials can damage or kill cells, and is expected to lead to the development of occupational and environmental exposure guidelines.

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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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