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

The January 25-29, 2010, African regional meeting on the implementation of the Strategic Approach to International Chemicals Management (SAICM) included a workshop on nanotechnology. During the meeting, 53 governments adopted a resolution that calls for a ban on the shipment of waste containing nanomaterials to countries that cannot adequately manage them; legal provisions to ensure the safe use and disposal of nanomaterials; and bio-monitoring for people exposed to nanomaterials. Importantly, it is not clear what exactly waste “containing nanomaterials” includes. The resolution also calls on governments to adopt a “no data, no market” principle, which requires comprehensive hazard assessment information to be submitted before a nanotechnology can be commercialized. The resolution is not binding and recognizes the right of countries to allow the import and use of nanomaterials, but urges that a precautionary approach be taken.

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On March 18, 2010, the United Kingdom (UK) Department for Business, Innovation and Skills (BIS) announced publication of UK Nanotechnologies Strategy: Small Technologies, Great Opportunities, which sets out how the government intends to take action to ensure that everyone safely benefits from the societal and economic opportunities that these technologies offer, while addressing the challenges that they might present. The Strategy includes the following key actions:

• Government chief scientific advisers to review coordination of nanotechnologies research across government, including research on safety issues;
• A new website to keep the public informed about government work on nanotechnologies;
• A new Nanotechnologies Collaboration Group to facilitate ongoing communication and collaboration between government, academia, industry, and other interested parties;
• A new Ministerially led Nanotechnologies Leadership Group to address barriers to commercial growth in this area; and
• Government to explore a new industry reporting scheme with a broader scope covering nanomaterials, as well as products containing them.

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On March 16, 2010, the EP Environment Committee approved draft legislation intended to modernize, simplify, and clarify food labeling within the EU. The legislation would make minor changes to existing rules on required labeling information, such as name, list of ingredients, “best before” or “use by” date, specific conditions of use, and add a requirement to list key nutritional information. The Committee added that showing the country of origin should also be mandatory in some cases. According to EP, the Committee “demand[s] that products containing nano-materials, be clearly labelled as such, using the epithet ‘nano’ in the ingredient list.” To provide industry time to meet the new requirements, the regulation would enter into force 20 days after its publication in the EU Official Journal, but the rules on nutrition labeling would take effect three years thereafter. For food business operators with fewer than 100 employees and an annual turnover and/or annual balance sheet total under €5 million, the rules would take effect five years thereafter. EP plans its first reading of the proposed legislation in plenary session at the end of May 2010. The Council will then have to adopt its position, before the proposal is again debated in the EP Environment Committee.

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On March 10, 2010, Member of Parliament Peter Julian (NDP) tabled legislation (Bill C-494) in the House of Commons that would amend the Canadian Environmental Protection Act, 1999 (CEPA) to implement procedures for the investigation and assessment of nanomaterials. The bill includes provisions concerning adding nanomaterials to the Domestic Substances List (DSL), notification of significant new activity, risk assessment procedures, and would establish a public inventory of nanotechnology and nanomaterials in Canada. According to the New Democratic Party of Canada (NDP), the proposed amendments “will help implement a national strategy to guide the development of nanotechnology.”

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On March 4, 2010, the U.S. Environmental Protection Agency (EPA) Design for the Environment (DfE) Program announced a partnership led by the DfE Program and Office of Research and Development (ORD). The partnership is conducting a screening-level life-cycle assessment of currently manufactured lithium-ion battery technologies and a next generation battery component that uses single-wall carbon nanotube technology. According to the DfE Program, the partnership offers the opportunity to mitigate current and future impacts and risks by helping battery manufacturers and suppliers identify materials and/or processes associated with the greatest environmental impacts throughout the life cycle of their products, and identify areas that could benefit from increased energy efficiency.

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In a March 2, 2010 letter, the Food and Drug Administration (FDA) responded to the Environmental Working Group’s (EWG) July 15, 2009, letter concerning sunscreen guidelines. EWG criticized the FDA for not having guidelines for sunscreen safety and efficacy. According to EWG, companies continue to profit by misleading consumers about the protection offered by their products. EWG urged FDA to publish a final rule for its August 2007 draft sunscreen guidelines. In its March 2, 2010, response, FDA stated that most sunscreen products are currently marketed under an over-the-counter drug monograph entitled “Sunscreen Drug Products for Over-the-Counter Human Use.” According to the letter, FDA received over 3,000 comments in response to its August 2007 draft sunscreen guidelines. FDA concludes its response by stating:

Although we understand your concern regarding the protracted nature of this process, we trust that you will appreciate the need for us to continue to fully investigate and evaluate new research and development for sunscreen products, permit adequate opportunity for public comment, and weigh all research and development fairly and with full input from FDA subject area experts as well as industry stakeholders and the American public.

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During the 68th annual meeting of the American Academy of Dermatology, on March 4, 2010, dermatologist Adnan Nasir, M.D., Ph.D., F.A.A.D., gave a presentation on nanotechnology and how nanoparticles may eventually be used in cosmetic products. According to Dr. Nasir, the cosmetic industry leads all other industries in the number of patents for nanoparticles, which have the potential to enhance sunscreens, shampoos, conditioners, lipsticks, eye shadows, moisturizers, deodorants, after-shave products, and perfumes.  Nanoparticles used in sunscreens increase protection and coverage on the skin, while being less visible than microparticles. In anti-aging products, nanotechnology may allow active ingredients to penetrate the top layer of the skin. Researchers are currently exploring nanoparticle treatments of conditions such as melanoma.  Dr. Nasir noted, however, that dermatologists are concerned about the potential health risks posed by nanotechnology, and “anxiously await” the Food and Drug Administration’s review of the safety of nanoparticles.

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On March 1, 2010, the European Commission (EC) issued a request, via the accelerated procedure, for a scientific opinion on the scientific basis for the definition of the term “nanomaterial” from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). According to the EC, its services “urgently need to elaborate a working definition of the term ‘nanomaterials’ to ensure the consistency of forthcoming regulatory developments to guide, as appropriate, the effective implementation of existing regulation, and to contribute to international work and dialogue on nanotechnology definitions.” The EC states that it needs “clarification on the size ranges and other relevant characteristics and corresponding metrics reported in the scientific literature, the types of physical and chemical properties particular to nanomaterials, the relevant thresholds, as well as the most appropriate metrics to express such thresholds.” The deadline is May 2010.

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On March 1, 2010, Health Canada began a public consultation on its adoption of the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials (Interim Policy). Although Health Canada is accepting comments, it states that the Interim Policy “is effective immediately.” In preparing the Interim Policy, Health Canada states that it sought the informal feedback of some international stakeholders, industry trade groups, standards associations, and other Canadian federal departments. Comments are due August 31, 2010, and Health Canada intends to use the comments to update the Interim Policy as necessary.

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The NanoBusiness Alliance will hold its Ninth Annual Washington DC Roundtable on March 15-17, 2010, and it will begin with a networking dinner and reception. Legislative meetings are scheduled for March 16, 2010. On March 17, 2010, during the NanoBusiness Alliance Federal Roundtable, Charles Auer will moderate, and Lynn L. Bergeson will participate in, a panel on chemical and consumer product risk management policy and regulatory actions. The Roundtable is intended to stimulate dialogue between NanoBusiness Alliance members and federal agencies; provide members an opportunity to learn about the latest regulatory policy/impending regulatory actions and federal research initiatives; and familiarize NanoBusiness Alliance members with federal product approval authorities and processes and innovation strategies, with an emphasis on pending developments.

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