February 17, 2020

February 17, 2020

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February 14, 2020

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EPA to Require Up-Front Substantiation of All Non-Exempt Confidential Business Information Claims

The U.S. Environmental Protection Agency (EPA) has published its first guidance document in the Federal Register interpreting the new substantiation requirements for confidential business information (CBI) claims submitted under section 14 of the Toxic Substances Control Act (TSCA) (15 U.S.C. § 2601 et seq.). The Agency is changing its approach to implementing the new substantiation requirements. Rather than issuing substantiation requests for 25% of all non-chemical identity CBI claims received by EPA, beginning March 20, 2017 EPA will require up-front substantiation of all such claims. That is, companies must provide substantiation for all non-exempt chemical identity and non-chemical identity CBI claims at the time they submit such claims. EPA has yet to issue interpretive guidance on the scope of the exemptions from substantiation, which appear at section 14(c)(2) of TSCA, or how to invoke these exemptions in submissions to the Agency.

As to what is required to substantiate CBI claims for which there are no existing TSCA requirements, EPA suggests that companies provide answers to the questions listed in the Agency-wide, general CBI regulations at 40 C.F.R. § 2.204(e).

Existing EPA confidentiality rules at 40 CFR part 2, section 2.204(e) provide substantiation questions that the Agency may specifically request answers to, pursuant to the procedures in those regulations. While those specific questions are not dictated by the self-executing substantiation requirement in TSCA section 14(c)(3), EPA suggests that companies look to those questions for guidance as to how to fulfill the TSCA section 14(c)(3) substantiation requirement for information that is not currently subject to an existing regulatory up-front substantiation requirement. . . .

For information that is currently subject to a regulatory up-front substantiation requirement (for example, chemical identity CBI claims in the Chemical Data Reporting rule, under 40 CFR 711.30), the terms of that requirement, including the substantiation questions required, will continue to govern the substantiation.

Since TSCA amendments took effect last June, EPA had been issuing letters requesting companies to provide answers to 11 detailed questions, and 15 detailed questions for health and safety information, for purposes of substantiation. By contrast, section 2.204(e)(4) asks only the following nine questions:

(i) The portions of the information which are alleged to be entitled to confidential treatment;

(ii) The period of time for which confidential treatment is desired by the business (e.g., until a certain date, until the occurrence of a specified event, or permanently);

(iii) The purpose for which the information was furnished to EPA and the approximate date of submission, if known;

(iv) Whether a business confidentiality claim accompanied the information when it was received by EPA;

(v) Measures taken by the business to guard against undesired disclosure of the information to others;

(vi) The extent to which the information has been disclosed to others, and the precautions taken in connection therewith;

(vii) Pertinent confidentiality determinations, if any, by EPA or other Federal agencies, and a copy of any such determination, or reference to it, if available;

(viii) Whether the business asserts that disclosure of the information would be likely to result in substantial harmful effects on the business' competitive position, and if so, what those harmful effects would be, why they should be viewed as substantial, and an explanation of the causal relationship between disclosure and such harmful effects; and

(ix) Whether the business asserts that the information is voluntarily submitted information as defined in §2.201(i), and if so, whether and why disclosure of the information would tend to lessen the availability to EPA of similar information in the future.

These are less specific than the 11 to 15 questions EPA had been posing to CBI claimants immediately following enactment of the Lautenberg Chemical Safety for the 21st Century Act, and it is unclear at this time what criteria EPA will apply in reviewing these claims. Although there is longstanding jurisprudence on what constitutes confidential business information generally, whether information is subject to CBI treatment under TSCA, specifically, has not been the subject of extensive litigation.

For CBI claims made between June 22, 2016 and the effective date of this guidance, companies will need to provide substantiation unless the claims were already substantiated or are exempt from substantiation. Such submitters will have 240 days from March 20, 2017 to submit this substantiation. If no substantiation is provided, then EPA will notify the company that it has 30 days to submit substantiation or EPA will deem its CBI claims to have been waived.

EPA is not officially seeking comments on this guidance, but it has established a public docket for it (Docket ID No. EPA-HQ-OPPT-2017-0026). Technically, interpretive guidance is not subject to notice and comment rulemaking under the Administrative Procedure Act unless a court finds that it is actually a legislative rule that creates at new duty (rather than clarifying the scope of a duty), which EPA disguised as guidance. On the other hand, because the CBI notice is simply guidance, the new Administration could, in theory, easily rescind it. This is true particularly in light of the U.S. Supreme Court's decision in Perez v. Mortgage Bankers Ass'n, 575 U.S. __, 135 S. Ct. 1199 (2015), holding that an agency's interpretive guidance may be changed without notice and comment rulemaking under the APA.

The CBI guidance was signed by the departing Assistant Administrator of EPA's Office of Chemical Safety and Pollution Prevention, Mr. Jim Jones, and dated January 13, 2017.

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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...

Herbert Estreicher Ph.D., Keller Heckman, International Regulation Lawyer, Environmental law Attorney

Herbert Estreicher, Ph.D. joined Keller and Heckman in 2003. He has a broad practice in international environmental regulatory law.

Dr. Estreicher has an interdisciplinary approach combining law and science. He represents leading manufacturers of chemicals, pesticides, insect repellents, food additives, and consumer products before Federal and State regulatory agencies.

Dr. Estreicher provides advice on product liability risk control and assists clients with crisis management for embattled products, including chlorinated pesticides, wood preservatives, dioxins, and persistent, bioaccumulative, and toxic (PBT) chemicals. He helps clients secure and maintain chemical approvals and pesticide registrations in Canada and Europe, advises clients on responding to the CEPA challenge program, and provides advice on European chemical directives and initiatives, such as the European Union (EU) Marketing and Use Directive, the EU Biocidal Products Directive, and the EU Registration, Evaluation and Authorization of Chemicals (REACH) regulation. Dr. Estreicher also represents clients in the negotiation and development of various international environmental instruments governing persistent organic pollutants (POPs), has been actively involved in the Great Lakes Binational Toxics Strategy, and has participated in the Canadian Strategic Options Process (SOP). He is actively engaged in the areas of TSCA Reform and the California Green Chemistry Initiative. His extensive background in organic chemistry, risk assessment and bioengineering is valued highly by clients in the chemical, nanotechnology, and biotechnology industries.

Eric Gotting, Keller Heckman, ligation attorney, appeals lawyer, personal injury

Eric Gotting joined Keller and Heckman in 2011. He serves as a partner in the firm's litigation and environmental practice groups specializing in complex civil and appellate matters, with a focus on toxic tort, environmental, and corporate litigation.

Litigation and Environmental Experience

Mr. Gotting has handled cases across the country, having tried matters to verdict and argued appeals before federal and state appellate courts. His experience includes class actions, mass tort litigation, and...

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...