June 27, 2017

June 26, 2017

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EPA Will Publish Draft Guidance for Reporting Nanoscale Materials for Comment

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.”  EPA states in the pre-publication notice that the guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the January 12, 2017, final rule.  The final rule involves one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials.  The notice lists the following North American Industrial Classification System (NAICS) codes to help readers determine whether the document may apply to them:

  • Chemical Manufacturing or Processing (NAICS Code 325);
  • Synthetic Dye and Pigment Manufacturing (NAICS Code 325130);
  • Other Basic Inorganic Chemical Manufacturing (NAICS Code 325180);
  • Rolled Steel Shape Manufacturing (NAICS Code 331221);
  • Semiconductor and Related Device Manufacturing (NAICS Code 334413);
  • Carbon and Graphite Product Manufacturing (NAICS Code 335991);
  • Home Furnishing Merchant Wholesalers (NAICS Code 423220);
  • Roofing, Sliding, and Insulation Material Merchant Wholesalers (NAICS Code 423330); and
  • Metal Service Centers and Other Metal Merchant Wholesalers (NAICS Code 423510).

EPA states that it will make the draft guidance available on its website at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/control-nanoscale-materials-under#guidance, and will also be available in Docket ID number EPA-HQ-OPPT-2010-0572.  EPA states that it will accept comments regarding the guidance, but not regarding the rule itself, “which has already been finalized.”  Comments will be due 30 days after the notice is published in the Federal Register.  More information regarding the final rule is available in our article, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials

©2017 Bergeson & Campbell, P.C.

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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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