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EPA Intends to Promulgate Final Nanoscale Materials Rule in October 2016

According to an item in the Spring 2016 Regulatory Agenda, the U.S. Environmental Protection Agency (EPA) is “developing a final rule related to” its April 6, 2015, proposal to require reporting and recordkeeping requirements under Section 8(a) of the Toxic Substances Control Act (TSCA) for certain chemical substances when they are manufactured or processed at the nanoscale. EPA proposed to require persons that manufacture, import, or process, or intend to manufacture, import, or process these chemical substances to report to EPA certain information, including the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects.  The proposal involves one-time reporting for existing nanoscale materials and one-time reporting for new discrete nanoscale materials before they are manufactured or processed.

According to EPA, this information would facilitate its evaluation of the materials and a determination of whether further action, including additional information collection, is needed.  EPA notes that, consistent with the President’s memorandum for Executive Departments and Agencies regarding Principles for Regulation and Oversight of Emerging Technologies, “this rule would facilitate assessment of risks and risk management, examination of the benefits and costs of further measures, and making future decisions based on available scientific evidence.”  While the regulatory agenda item states that EPA intends to promulgate a final rule in October 2016, EPA has not indicated how it intends to address comments on the proposed rule.  The Office of Management and Budget (OMB) took several years to review the proposed rule.  OMB’s Office of Information and Regulatory Affairs (OIRA) issued a December 17, 2015, memorandum concerning “Regulatory Review at the End of the Administration,” which states that “agencies should strive to complete their highest priority rulemakings by the summer of 2016 to avoid an end-of-year scramble that has the potential to lower the quality of regulations that OIRA receives for review and to tax the resources available for interagency review.”  EPA has not yet submitted a final rule to OMB for review.

©2022 Bergeson & Campbell, P.C.National Law Review, Volume VI, Number 140
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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...

202-557-3809
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