The U.S. Environmental Protection Agency (EPA) announced on January 5, 2021, that it is inviting small businesses, governments, and not-for-profit organizations to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels.
One Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluation for perchloroethylene. As reported in our December 17, 2020, memorandum, of the 61 conditions of use that EPA reviewed for perchloroethylene, EPA found that 59 present unreasonable risks to workers, occupational non-users (ONU), consumers, and bystanders. The conditions of use that EPA determined do not present an unreasonable risk are distribution in commerce and industrial and commercial use in lubricants and greases for penetrating lubricants and cutting tool coolants. EPA found no unreasonable risks to the environment.
The second Panel will focus on a risk management rulemaking for n-methylpyrrolidone (NMP). As reported in our December 29, 2020, memorandum, of the 37 conditions of use that EPA reviewed for NMP, EPA found that 26 present unreasonable risks to workers and consumers. These uses include an unreasonable risk to workers when domestically manufacturing or importing NMP, processing NMP for a variety of uses, and when used in a variety of industrial and commercial conditions of use. These uses also include an unreasonable risk to consumers from one consumer use. EPA found that NMP does not pose an unreasonable risk when distributed in commerce or in a variety of industrial and commercial and consumer applications. EPA also determined that NMP does not present an unreasonable risk to the environment and the general population.
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 companies, communities, or organizations and advise the Panels 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 rules’ 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 and must be received by January 19, 2021.
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes 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.