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Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)
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Integrated Approach for Biofuel Premanufacture Notices

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.

This effort supports the goals under EPA’s Renewable Fuel Standard (RFS) program, which has Congressional mandates to replace or reduce quantity of petroleum-based transportation fuel, heat oil, or jet fuel with biofuels that are projected to have lower lifecycle greenhouse gas emissions. This effort also supports EPA’s 2021 Climate Adaptation Action Plan which describes steps the agency will take to address the impacts of climate change on communities across the country, as part of the Biden-Harris Administration’s actions to confront the climate crisis.

Under this effort, NCD formed a dedicated team to collaborate on the review of premanufacture notices (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.  NCD has 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, which will help 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, which will help 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 (SNURs).

On this page:

  • Outreach and Training
  • Additional Information

Outreach and Training

NCD is launching outreach and training for interested stakeholders in the biofuels sector. The training will 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.

EPA is holding a kick-off meeting on February 9, 2022 to provide an overview of this initiative and answer questions from stakeholders. Register for the meeting.

Other planned outreach and training related to this biofuels initiative can be found in the table below.

Schedule and Materials

Webinar Date *Materials Registration Link
Kick-Off Meeting February 9, 2022 Biofuels Kick-Off Meeting Presentation (pptx) Register for the meeting.
TSCA requirements and premanufacture notice (PMN) process February 23, 2022 Review of New Chemical Substances under TSCA Presentation (pptx) Register for the meeting.
TSCA Inventory, nomenclature and Bona Fide process March 9, 2022 TSCA Inventory, Nomenclature and Bona Fide Process Presentation (pptx) Register for the meeting.
New chemical risk assessments and applications of the tools and models March 23, 2022 New Chemical Risk Assessments and Applications of Tools and Models (pptx) Register for the meeting.
New chemicals risk management actions, including TSCA section 5 orders and significant new use rules (SNURs) April 6, 2022 New Chemicals Risk Management Actions (pptx) Register for the meeting.

*Training materials will be added prior to the training session.

Additional outreach and training sessions, including training opportunities applicable to all new chemical submitters, may be added based on stakeholder interest and feedback.

Additional Information

Read about EPA’s Tools, Models, and Databases

Read about EPA’s Sustainable Future’s Program

Read EPA’s October 2021 Climate Adaption Action Plan

Read about EPA’s Renewable Fuel Standard (RFS) program

Read the press release.

  • Reviewing New Chemicals under the Toxic Substances Control Act (TSCA) Home
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  • Filing a Premanufacture Notice with EPA
  • Regulatory Actions Under TSCA section 5
  • Premanufacture Notice Status
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Last updated on April 5, 2022
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