October 21, 2019

October 21, 2019

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October 18, 2019

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EPA Issues Penalty Associated with Violation of R&D Exemption

In September 2018, the U.S. Environmental Protection Agency (EPA) issued a consent agreement with Chevron USA, Inc. (Chevron) related to an alleged violation of the Toxic Substances Control Act (TSCA). 

EPA’s issuance of a consent agreement for the alleged TSCA violation is not especially newsworthy.  Neither is the agreed upon penalty for the violation, which could be considered minor based on the penalty provisions allowed under TSCA.  What is newsworthy here is that the alleged violation, technically three as the violation occurred on three separate days, was related to the research and development (R&D) exemption.  Specifically, EPA alleged that Chevron did not appropriately label chemicals that it had distributed to other companies for R&D purposes.  In our experience, the R&D exemption under TSCA is seldom the subject of enforcement scrutiny.  This may be changing.

 The R&D exemption is a critical aspect of TSCA and it offers many companies significant flexibility to research new chemical innovations.  The exemption is self-implementing and thus does not require pre-approval by or submissions to EPA.  Nonetheless, there are specific restrictions and recordkeeping requirements associated with reliance on that exemption.  The consent agreement at issue here confirms that EPA will hold companies accountable to these requirements.  The enforcement action is an important reminder to all entities relying upon the R&D exemption to ensure that they comply strictly with each element of the exemption requirements as identified under TSCA Section 5(h)(3).

Companies relying on the R&D exemption for new chemical development may wish to review internal files and processes to ensure compliance, as EPA has shown its intent to pursue violations and associated penalties for non-compliance instances.

©2019 Bergeson & Campbell, P.C.

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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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Kathleen Roberts, Bergeson Campbell, Consortia Management, industry group resource,  Toxic Substance Control Act regulations, cost effective manager leader
Vice President, B&C® Consortia Management, L.L.C.

Kathleen M. Roberts is Vice President of B&C® Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C. (B&C®). In her leadership role at BCCM, Ms. Roberts is an essential resource for industry groups, providing cost effective management support and administrative services for multiple industry consortia engaged in advocacy, research, public outreach, and communication activities. In addition, Ms. Roberts serves as a non-attorney professional with B&C, addressing domestic and international chemical control regulations and related chemical management issues. She is a recognized expert on the Toxic Substances Control Act (TSCA), with over 25 years' experience in engaged advocacy, compliance, and communication activities with industry and U.S. Environmental Protection Agency (EPA) staff. In June 2013, Ms. Roberts was invited to provide expert testimony on understanding the history and impact of TSCA before the U.S. House Energy and Commerce Subcommittee on Environment and the Economy.

Ms. Roberts writes and speaks frequently about the opportunities for industry to use TSCA to its competitive advantage and the challenges newer chemicals and technologies sometimes present under TSCA regulations. Her articles have appeared in The Environmental Forum, Industrial Biotechnology, Law 360, and Biofuels Digest, among others. She has presented numerous TSCA workshops and seminars, including at the National Association for Chemical Distributors (NACD) annual meeting, the BIO World Congress, the Chemical Watch U.S. Regulatory Summit, and the inaugural Product Stewardship Society conference.

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Richard Engler PhD, Bergeson Campbell Law Firm, Senior Chemist
Senior Chemist

Richard E. Engler, Ph.D. is Senior Chemist with Bergeson & Campbell, P.C.  Dr. Engler is a 17-year veteran of the U.S. Environmental Protection Agency (EPA) and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA's Office of Pollution Prevention and Toxics (OPPT) and leader of EPA's Green Chemistry Program.  He has participated in thousands of Toxic Substances Control Act (TSCA) substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or...

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