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Preliminary Lists Identifying Manufacturers Subject to Fee Obligations for EPA-Initiated Risk Evaluations under TSCA Section 6 Will Be Published January 27

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority substances for risk evaluation and for which fees will be charged.  Publication of the Federal Register notice will begin a 60-day comment period during which manufacturers (including importers) will be required to self-identify as a manufacturer of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA.  EPA states that where appropriate, entities may also avoid or reduce fee obligations by making certain certifications consistent with the final rule on fees for the administration of the Toxic Substances Control Act (TSCA).  During the 60-day comment period, the public will have the opportunity to correct errors or provide comments on the preliminary lists.  According to the notice, EPA expects to publish final lists of manufacturers (including importers) subject to fees no later than concurrently with the publication of the final scope document for risk evaluations of the 20 high-priority substances.  Manufacturers (including importers) identified on the final lists will be subject to applicable fees.

Once the Federal Register notice is published, the preliminary lists will be available in docket number EPA-HQ-OPPT-2019-0677 at http://www.regulations.gov and on EPA’s website at http://www.epa.gov/TSCA-fees.  EPA states that it developed each preliminary list “using the most up-to-date information available, including information submitted to the Agency (e.g., information submitted under TSCA section 8(a) (including the Chemical Data Reporting (CDR) Rule) and section 8(b), and to the Toxics Release Inventory (TRI)).”  According to the notice, EPA considered using other sources of information, such as publicly available information or information submitted to other agencies to which EPA has access, but EPA “concluded that data quality limitations would create more false positives than appropriate additions to the lists.”  Additionally, EPA notes that it believes the Self-Identification process, established by 40 C.F.R. Section 700.45(b)(5), will be sufficient to identify additional manufacturers (including importers), as appropriate.  To include the two most recent CDR reporting cycle data (collected every four years) and to account for annual or other typical fluctuations in manufacturing (including import), EPA states that it used six years of data submitted or available to it under CDR and TRI to create the preliminary lists (2012-2018).

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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...

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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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