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

The European Agency for Safety and Health at Work (EU-OSHA) announced June 19, 2009, the publication of the Literature Review -- Workplace Exposure to Nanoparticles, which reviews the most recent publications on nanoparticles and focuses on the possible adverse health effects of workplace exposure. The report focuses on the possible adverse health effects of workplace exposure to engineered nanomaterials and possible subsequent activities taken to manage the risk. The report does not include nanomaterials originating from natural sources, as well as non-intended nanoscale by-products, such as diesel engine exhaust, and welding fumes. To provide a broad overview, EU-OSHA collected information from different sources, such as scientific literature, policy documents, legislation, and work programs. EU-OSHA gave priority to documents from the European Union (EU), although national and international activities are also described. The report considers studies published up to November 2008. The report identifies the following topics as priorities for future actions and activities:

• Identification of nanomaterials and description of exposure;
• Measurement of exposures to nanomaterials and efficacy of protective measures;
• Risk assessment of nanomaterials in line with the current statutory framework;
• In vivo studies for assessment of the health effects of nanomaterials;
• Validation of the in vitro methods and methods of physico-chemical properties as methods to determine health effects; and
• Training of workers and practical handling guidelines for activities involving nanomaterials in the workplace.

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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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