October 22, 2019

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Don't Forget TSCA CBI Substantiations are Due September 19th

Confidential Business Information (CBI) claims asserted in any Toxic Substances Control Act (TSCA) submissions made between June 22, 2016 and March 21, 2017 must be affirmatively substantiated by September 19, 2017, unless they fall within one of seven classes of information exempt from substantiation under section 14(c)(2) of TSCA. If it is questionable whether an exemption applies, one may consider formally invoking the exemption by September 19th given the lack of significant guidance on the scope of these exemptions.  

According to the U.S. Environmental Protection Agency (EPA), if no substantiation for a claim has been received by this date, the Agency will provide the affected business 30 days' notice and a "final opportunity" to substantiate the claim. CBI claims that are not substantiated at the end of the 30 days will be considered withdrawn, and "the information may be made public with no further notice to the affected business." Waiting for EPA to issue such notice and then submitting the substantiation may limit a company's opportunity to bolster its justification if EPA rejects the initial substantiation. A second notice is not required by statute prior to disclosure. A proper submission by September 19th eliminates this risk.

© 2019 Keller and Heckman LLP


About this Author

 Thomas C. Berger, Keller Heckman, Environmental Protection lawyer, Product Liability Management Attorney

Tom Berger joined Keller and Heckman in 1993. Mr. Berger is a partner in Keller and Heckman's Washington DC office and heads Keller and Heckman's Indianapolis satellite office.

Mr. Berger has extensive experience in representing foreign and domestic companies, large and small, in a broad range of areas, including counseling, advocacy, and rulemaking in environmental law, occupational safety and health law, contracts, EPA enforcement proceedings, and chemical and product liability management. Mr. Berger assists clients in bringing new products to...

David G. Sarvadi, Keller Heckman, Occupational Health and Safety lawyer, Labor Litigation attorney

David Sarvadi joined Keller and Heckman in 1990. Mr. Sarvadi practices in the areas of occupational health and safety, toxic substance management, pesticide regulation, employment law, and product safety.

Mr. Sarvadi represents clients before a variety of federal and state enforcement agencies in legal proceedings involving OSHA citations, EPA Notice of Violations, TSCA consent orders, CPSC Notices, FIFRA Stop Sale Use and Removal Orders, and EEOC Charges of Discrimination. He works with clients in developing, reviewing, and auditing compliance programs in all of these areas, and in obtaining agency rulings on proposed or novel activities and questions, seeking interpretations of regulations as they apply to specific sets of facts.  He has a background in occupational safety and health, having worked as an industrial hygienist for more than 15 years and became a Certified Industrial Hygienist in 1978, a designation he held until he voluntarily relinquished it in 2010. Prior to becoming an attorney, he was a principal in a small consulting firm, and managed a corporate industrial hygiene and product safety program for a Fortune 500 company. Mr. Sarvadi was selected by the National Academy of Sciences to participate in a panel of the Institute of Medicine that was asked to review a study by the National Institute for Occupational Safety and Health on the use of respirators in the U.S. He was asked to participate because of his expertise in law and industrial hygiene.

Adrienne M. Timmel, Keller Heckman, Pre-Market Chemical Approval Lawyer, Products Safety Attorney

Adrienne Timmel practices in all areas of environmental law and also advises clients on product safety and energy performance matters. In particular, Ms. Timmel assists clients in obtaining pre-market approval of chemicals and pesticides in the U.S. and international markets. She has helped clients navigate and comply with the Federal fuels regulations and Federal energy efficiency regulations for residential appliances and commercial equipment.  Her work has also included counseling clients in the development of biofuels and engaging in settlement negotiations with the...