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

During the Helsinki Chemicals Forum 2010, Jukka Malm, European Chemicals Agency (ECHA) Assessment Director stated that ECHA is revising its Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) guidance documents to include technical instructions to help companies include nanomaterials in their registration dossiers and other compliance obligations for substances they make or import. According to Malm, ECHA is following “international developments,” particularly work by the Organization for Economic Cooperation and Development (OECD) concerning nanomaterial safety and testing. Malm stated: “As results become available, we are trying to introduce them into our guidance documents for steering industry on how to implement REACH in practice in their registration dossiers and other obligations.”

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On April 27, 2010, ILO published a booklet entitled “Emerging Risks and New Patterns of Prevention in a Changing World of Work,” which summarizes new occupational safety and health issues, including those related to technical innovations such as nanotechnology. The booklet states:

There is a big knowledge gap between advances in the application of nanotechnology and its impact on health. Due to the extensive and highly diversified use of nanomaterials in industry, the number of workers exposed is also difficult to estimate. While little is known about the health and environmental impact of these new materials, it is likely that workers will be among the first to experience high rates of exposure.

According to ILO, the need to share information about emerging risks is “vital, at both the national and international levels.” ILO notes that “[t]he study of nanomaterials, for example, illustrates the importance of knowledge sharing in the development and application of new technologies, whereby the identification and assessment of associated hazards and risks need to be considered and communicated at a stage before widespread application in industry.”

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The Organization for Economic Cooperation and Development (OECD) posted on May 5, 2010, two reports concerning nanomaterials:

• Report of the Workshop on Risk Assessment of Manufactured Nanomaterials in a Regulatory Context: This is the Report of the September 2009 Workshop on Risk Assessment of Manufactured Nanomaterials in Regulatory Context, which was co-hosted by the Business and Industry Advisory Committee (BIAC) and the Society for Risk Analysis (SRA). According to OECD, the Workshop provided an opportunity to discuss critical issues specific for risk assessment of nanomaterials in a regulatory context, and to identify approaches for risk assessment based on the current state of knowledge.

• Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials: According to OECD, this Report presents the information obtained from the Questionnaire on Regulatory Regimes on Manufactured Nanomaterials. OECD analyzed 24 legislations from nine jurisdictions. The Report summarizes objectives and activities covered by each legislation, as well as information on registration/notification, assessment, and management of substances that are either premarket or already in commerce. It also provides a number of legislative features identified in the legislations for consideration when amending or drafting legislation for regulatory oversight of nanomaterials and their products.

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On May 4, 2010, the European Parliament (EP) Committee on the Environment, Public Health, and Food Safety voted on draft legislation regarding “novel foods,” which are defined as those that have not been consumed to a significant degree in the European Union (EU) before May 1997. Under the legislation, foods produced by nanotechnology processes would be required to undergo risk assessment before being approved for use, and approved products would be subject to labeling requirements. According to the Committee, foods produced by nanotechnology processes must remain excluded from the European Community (EC) list until they have undergone specific and adequate risk assessments, and the possible health effects of materials at nanoscale are better understood. The draft legislation would define nanomaterials as having one or more dimensions less than 100 nanometers (nm). All ingredients present in nano-form would need to be clearly indicated in the list of ingredients. The EP plenary vote on the draft legislation is scheduled for July 2010.

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On April 29, 2010, during the U.S. Environmental Protection Agency’s (EPA) Pesticide Program Dialogue Committee (PPDC) meeting, William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), presented slides regarding nanotechnology and pesticides. Jordan briefly described how OPP is defining nanoscale materials and how the technology is being applied to the field of pesticides. His presentation described OPP’s recent consultation with EPA’s Scientific Advisory Panel (SAP) concerning nanosilver and other nanometal pesticide products, as well as other ongoing regulatory activity and future actions OPP intends to take.

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