July 13, 2020

Volume X, Number 195

July 13, 2020

Subscribe to Latest Legal News and Analysis

July 10, 2020

Subscribe to Latest Legal News and Analysis

EPA To Establish Negotiated Rulemaking Committee Under Amended TSCA

On December 15, 2016, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act.  81 Fed. Reg. 90843.  The NRC will implement the amended Toxic Substances Control Act (TSCA) Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3 years after the date of enactment … a proposed rule providing for limiting the reporting requirements under this subsection for manufacturers of any inorganic byproducts, if the byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.”

Earlier this fall, we noted the significance of this rulemaking for many entities subject to reporting requirements under TSCA’s Chemical Data Reporting (CDR) provisions under Section 8(a).  A “byproduct” is defined as a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture.  EPA is of the view that byproducts without a separate commercial value are nonetheless produced for the purpose of obtaining commercial advantage since they are part of the manufacture of a chemical substance produced for commercial purpose.  Accordingly, byproducts are considered manufactured substances under TSCA and must be listed on the TSCA Inventory and, therefore, reportable under the CDR -- unless they are exempt.  Byproducts are exempt from Inventory listing and CDR reporting if their only commercial purpose is use by public or private organizations that burn it as a fuel, dispose of it as a waste, or extract component chemical substances from it for commercial purposes.

EPA has interpreted “extract component chemical substances from it” narrowly and has determined the exemption is voided if an extraction process involves a chemical reaction.  Stakeholders have long asserted that this interpretation discourages recycling programs that necessarily involve a chemical reaction, processes that are frequently used to extract commercially valuable metals or other materials from byproducts that would otherwise be destined for disposal.  The speed with which EPA has moved to implement this provision reflects EPA’s interest in ensuring this regulatory disconnect is addressed before the next CDR reporting cycle in 2020.

The notice states that the main purpose of the NRC is to conduct discussions in a good faith attempt to reach consensus on proposed regulatory language.  The notice provides a clear and comprehensive discussion of the negotiated rulemaking process and procedures, initially identifies specific parties that may be interested in participation, and requests comment on the extent to which the approaches described in the notice are adequate and appropriate.  The notice should be carefully reviewed by any entity having an interest in this issue.  Comments are due by January 17, 2017

We note in addition that the notice specifically discusses the Section 8(a) CDR rule as being relevant to the negotiation.  While we agree that the CDR is clearly of interest, we note that the negotiation as structured applies to any rule under Section 8(a), such as the Preliminary Assessment Information Rule (PAIR) (40 C.F.R. Part 712) and any chemical-specific Section 8(a) rules (40 C.F.R. Part 711).  At the same time, the negotiation as described in new TSCA is limited to Section 8(a) and does not address the issues of Inventory listing and potentially associated Section 5 notification requirements for inorganic byproducts.  We note also that as a FACA Committee, the NRC can consider and, by consensus, determine its interest in also picking up these closely related issues for discussion and attempt to develop a consensus approach.

©2020 Bergeson & Campbell, P.C.National Law Review, Volume VI, Number 350


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...

Charles M. Auer, Senior Regulatory and Policy Advisor, Toxic Substances Control Act, chemicals
Senior Regulatory and Policy Advisor

For more than three decades, Charles M. Auer, Senior Regulatory and Policy Advisor with Bergeson & Campbell, P.C. (B&C®), has provided sagacious, informed, and deeply insightful guidance on legal, policy, and scientific matters related to the regulation of chemicals under the Toxic Substances Control Act (TSCA) and related domestic and international chemical control laws.  Mr. Auer’s experience includes over 32 years at the U.S. Environmental Protection Agency (EPA), most recently as the Director of the Office of Pollution Prevention and Toxics (OPPT), responsible for implementation of TSCA. He offers clients a truly exceptional level of policy and technical expertise in domestic and international chemical regulation, including chemical testing, assessment, and management of new and existing chemicals under TSCA; strategies for compliance with major U.S. trading partners and under multilateral environmental agreements such as the Stockholm Convention; approaches such as green chemistry, pollution prevention, Safer Choice, and other safer substitutes to meet corporate product stewardship goals; and commercialization of products from emerging chemical technologies, including nanotechnology, synthetic biology, and intergeneric microorganisms.

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...