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By Christopher R. Blunck and Lynn L. Bergeson

In a letter dated July 28, 2020, the U.S. Environmental Protection Agency (EPA) acknowledged the receipt of a Toxic Substances Control Act (TSCA) Section 21 petition requesting EPA to “initiate a proceeding for the issuance of a risk management procedural rule under TSCA section 6” submitted on behalf of the National Association of Manufacturers, the American Coatings Association, the National Association of Home Builders, the Toy Association, and the U.S. Chamber of Commerce.  In the acknowledgement letter, EPA states that the request is not a valid petition under TSCA Section 21.  EPA goes on to state “[‌u]nder TSCA section 21, as it relates to TSCA section 6, any person may petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA section 6 imposing chemical-specific regulatory controls for setting forth facts showing such action is ‘necessary’” and that “Section 21 does not provide a means for petitioning EPA to initiate a procedural rule.”  The acknowledgement letter further states that “EPA will, however,  consider your request as a petition under the Administrative Procedure Act (APA) for the issuance of a procedural rule” and that the “petition is under review by the Office of Pollution Prevention and Toxics (OPPT), which is responsible for programs under TSCA.” 

As mentioned in our memorandum addressing the TSCA Section 21 petition, there are requirements under the APA that agencies respond to APA petitions for rulemakings within a reasonable time, that Petitioners are given prompt notice of a denial, and that a brief statement of the grounds for denial be included.  A denial of a petition under the APA may be judicially reviewed and set aside if determined to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 16, 2020, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels.  There will be one Panel for methylene chloride and one Panel for 1-bromopropane (1-BP).  According to EPA, each Panel will focus on EPA’s development of proposed rules to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluations for these chemicals.  As reported in our June 25, 2020, memorandum, and August 11, 2020, memorandum, EPA’s final risk evaluations showed unreasonable risks to workers and consumers under certain conditions of use.  EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluations.
 
According to EPA, the Regulatory Flexibility Act requires agencies to establish an SBAR Panel for rules that may have a significant economic impact on a substantial number of small entities.  The SBAR Panels will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panels will select SERs to provide comments on behalf of their company, community, or organization and advise the Panel on the potential impacts of the proposed rule on small entities.  EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rule requirements.  EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.  Self-nominations may be submitted online for the methylene chloride and 1-BP SBAR Panels and must be received by September 30, 2020.
 
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes one-on-one meetings with stakeholders and formal consultations with state and local governments, tribes, and environmental justice communities.”  EPA notes that there will also be an open public comment period on any draft risk management regulations.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 3, 2020, the American Coatings Association (ACA), National Association of Manufacturers, Toy Association, National Association of Home Builders, and U.S. Chamber of Commerce petitioned the U.S. Environmental Protection Agency (EPA) to develop a risk management procedural rule under the Toxic Substances Control Act (TSCA).  According to ACA’s June 15, 2020, press release, ACA “believes that a procedural rule would provide guard rails to ensure consistency, transparency and effective public communication in developing risk mitigation requirements for companies following EPA completion of a Risk Evaluation under TSCA.”  ACA states that a procedural rule “is needed to establish a central point of reference for all requirements and considerations involved in crafting a risk management rule regulating a specific chemical.”  The petitioners ask EPA to implement an updated risk management procedural rule addressing considerations under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act).  According to the press release, the petition lists and describes various risk mitigation considerations under the Lautenberg Act’s framework that should be addressed in a procedural rule, including considerations related to transparency, deadlines for compliance, notice, effective dates, exemptions for critical or essential use, coordination with and/or delegation to other agencies, and processes to amend a risk mitigation rule.  ACA states that EPA has 90 days from filing to grant or deny the petition.  If EPA grants the petition, EPA can enter into a public rulemaking process, as requested by petitioners, though it is not required to do so.  ACA notes that while the Administrative Procedure Act (APA) provides that “rules of agency organization, procedure, or practice” are exempt from notice and comment requirements, “petitioners believe that EPA should publish the requested section 6 risk management procedural rule for notice and comment because the information and opinions supplied by the public will inform the Agency’s views.”