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EPA Announces Effort to Streamline Review of Climate-Friendly New Chemicals

On January 21, 2022, the U.S. Environmental Protection Agency (EPA) announced a new effort under the Toxic Substances Control Act (TSCA) to streamline the review of new chemicals that could be used to displace current, higher greenhouse gas (GHG) emitting transportation fuels. The Office of Chemical Safety and Pollution Prevention’s (OCSPP) New Chemicals Division (NCD) has implemented a “robust, consistent, and efficient process to assess the risk and apply mitigation measures, as appropriate, for substitutes to petroleum-based fuels and fuel additives that use biobased or waste-derived sources to produce biofuels.” EPA states that this effort supports its goals under the Renewable Fuel Standard (RFS) program, as well as its 2021 Climate Adaptation Action Plan. According to the announcement, EPA has received over 30 biofuel premanufacture notices (PMN) “that collectively describe plans for close to 800 million gallons per year of production of advanced biofuels, that could contribute to annual volume mandates under the RFS program and help support the goals of energy security through increasing domestic production” within the United States.

The announcement includes:

New Chemicals Division Integrated Approach to Biofuels

Under this effort, NCD formed a dedicated team to collaborate on the review of PMNs for biobased or waste-derived feedstocks used to make transportation fuel substitutes with the goals to use the best available science while creating a consistent and efficient review process. EPA states that NCD developed a standardized process for the way biofuel PMNs are reviewed. For example, the same dedicated team will be conducting reviews for all biofuels PMNs, helping to ensure the assessments and determinations are consistent and aligned with requirements. Further, NCD will generate one report for biofuels PMNs that combines the six different risk assessments typically conducted for PMNs, helping to provide a clearer summary explanation of how EPA conducted its assessment and made its determination.

For risk management actions, NCD will apply appropriate mitigation measures to address any potential for unreasonable risk identified in an efficient and consistent manner within TSCA consent orders and significant new use rules (SNUR).

Outreach and Training 

According to the announcement, OCSPP is launching outreach and training for interested stakeholders in the biofuels sector to review TSCA requirements, outline the streamlined approaches for risk assessments and risk management actions, and provide information on how to navigate the new chemicals PMN process.

OCSPP will hold a kick-off meeting on February 9, 2022, to provide an overview of this initiative and answer questions from stakeholders. Registration for the meeting is open.

Other planned outreach and training related to this biofuels initiative include webinars on:

  • TSCA requirements and the PMN process;

  • The TSCA Inventory, nomenclature, and Bona Fide process;

  • New chemicals risk assessments, including applications of the tools, models, and databases; and

  • New chemicals risk management actions, including TSCA Section 5 orders and SNURs.

EPA states that it may add additional outreach and training sessions, including training opportunities applicable to all new chemical submitters, based on stakeholder interest and feedback.

©2022 Bergeson & Campbell, P.C.National Law Review, Volume XII, Number 24
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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...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...

202-557-3809
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