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) July 7, 2011, Regulatory Agenda includes several notices concerning nanoscale materials:

• Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in August 2011.
• Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. In addition, according to the notice, EPA is developing a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice regarding a TSCA Section 8(a) rulemaking was previously separate, but EPA states “those two efforts were combined into a single rulemaking.” EPA submitted a proposed rule regarding TSCA Section 8(a) reporting to the Office of Management and Budget (OMB) for review on November 22, 2010, where it remains. According to the notice, EPA intended to publish an NPRM in June 2011. Nothing has been published to date, however.

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On June 9, 2011, the Office of Science and Technology Policy (OSTP) announced that the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles specific to the regulation and oversight of applications of nanotechnology. The principles are intended to guide the development and implementation of policies, as described in the title “U.S. Decision-making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials” that occur at the agency level. According to OSTP, the principles reinforce the overarching principles for the regulation and oversight of emerging technologies released on March 11, 2011. The principles also reflect recommendations from a report on nanotechnology prepared by the President’s Council of Advisors on Science and Technology and, importantly, reflect the results of a multi-agency, consensus-based process lead by the National Economic Council (NEC), the Office of Management and Budget (OMB), OSTP, and the Office of the U.S. Trade Representative (USTR). OSTP states that the goals of all of these documents “are to achieve consistent approaches across different emerging technologies and to ensure the protection of public health and the environment while avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.”

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A March 11, 2011, memorandum from the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) sets forth the Obama Administration’s principles for regulation and oversight of emerging technologies, including nanotechnology. The ETIPC Co-Chairs include John P. Holdren, Assistant to the President for Science and Technology, Director, Office of Science and Technology Policy (OSTP); Cass R. Sunstein, Administrator, Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB); and Islam A. Siddiqui, Chief Agricultural Negotiator, U.S. Trade Representative.

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The U.S. Environmental Protection Agency’s (EPA) December 20, 2010, Regulatory Agenda includes several notices concerning nanoscale materials:

• Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in April 2011.
• Reporting Under TSCA Section 8(a) -- Under TSCA Section 8(a), EPA is developing a proposal to establish reporting requirements for certain nanoscale materials.  According to the notice, the rule would propose that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice states that EPA intends to issue an NPRM in February 2011. EPA submitted a proposed rule to the Office of Management and Budget (OMB) for review on November 22, 2010.
• Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2).  The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. EPA intends to issue an NPRM in February 2011.

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On November 22, 2010, the U.S. Environmental Protection Agency (EPA) submitted a proposed Toxic Substances Control Act (TSCA) Section 8(a) reporting rule to the Office of Management and Budget (OMB) for review. According to EPA’s April 26, 2010, Regulatory Agenda, the proposed rule would require persons who manufacture nanoscale materials notify EPA of certain information including available use, production volume, methods of manufacture and processing, exposure and release information, and available toxicity data pertinent to existing nanoscale materials. EPA states that the proposed reporting of these activities will provide it with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.

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According to the Office of Management and Budget (OMB) website, on July 30, 2010, OMB received from the U.S. Environmental Protection Agency (EPA) a notice concerning “Pesticide Products Containing Nanoscale Materials.” No additional information regarding the notice is available on OMB’s website. During the April 29, 2010, meeting of EPA’s Pesticide Program Dialogue Committee (PPDC), William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), stated that EPA was in the process of preparing a Federal Register notice on nanomaterials and pesticide products. The notice will announce a new interpretation of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(2) regulations, that the presence of a nanoscale material is reportable under FIFRA Section 6(a)(2). This controversial interpretation would apply to already registered products, as well as products pending registration. In the same notice, EPA is expected also to memorialize OPP’s view that an active or inert ingredient would be considered “new” if it is a nanoscale material. The new policy would apply even when a non-nanoscale form of that same active or inert is already in a FIFRA-registered product. On June 25, 2010, the U.S. Government Accountability Office (GAO) issued a report entitled Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk, which recommends, among other actions, that EPA should complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new. EPA responded that it agreed with GAO’s recommendation and is working on clarification of registrant’s responsibilities under FIFRA with respect to nanomaterials.

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