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EPA Submits Final TSCA Rule on Nanomaterials to OMB for Review

On October 7, 2016, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a final rule that would require reporting and recordkeeping information on certain chemical substances when they are manufactured or processed as nanoscale materials.  EPA issued a proposed rule, under Section 8(a) of the Toxic Substances Control Act (TSCA), on April 6, 2015.  EPA proposed to require persons that manufacture or process certain chemical substances when manufactured or processed at the nanoscale to report electronically 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.  EPA also proposed to require any persons who intend to manufacture or process chemical substances as discrete nanoscale materials after the effective date of the final rule to notify EPA of the same information at least 135 days before the intended date of commencement of manufacture or processing.  As reported in our May 19, 2016, blog item, 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.”

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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

Owner of Bergeson & Campbell, P.C. (B&C®), 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...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
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 initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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