By Lynn L. Bergeson and Carla N. Hutton
 
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.

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By Lynn L. Bergeson 

On December 28, 2021, EPA announced that it will hold a public virtual meeting to discuss biofuel greenhouse gas (GHG) modeling. EPA is soliciting information on the current scientific understanding of GHG modeling of land-based biofuels used in the transportation sector. According to EPA, the information gathered during this meeting will be used to inform current and future EPA actions, including the method for quantifying GHG emissions under RFS. Of particular interest to EPA, is input on:

• How to incorporate the best available science into an update of EPA’s biofuels lifecycle analysis (LCA); and
• The next steps EPA should take in this work area.

Hosted by EPA’s Office of Transportation and Air Quality in consultation with USDA and DOE, the virtual public meeting is scheduled for February 28, 2022, and March 1, 2022, from 12:00 p.m. to 4:00 p.m. (EST). EPA will also be accepting comments on these topics until April 1, 2022.

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By Lynn L. Bergeson 

According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG Hotline.” The audit also addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals.

OIG states that its objective is to determine the extent to which EPA uses and complies with applicable records management requirements, quality assurance requirements, and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks. OIG plans to conduct work with the Office of Chemical Safety and Pollution Prevention (OCSPP) in EPA headquarters. According to OIG, the anticipated benefits of the audit are “improved operational efficiency and greater human health and environmental protections.”

To expedite the audit, OIG asks that OSCPP provide the following information:

• Any training materials, handbooks, or other materials related to the review of new chemicals;
   
• Resource allocations for the New Chemicals Review Program for FYs 2018 through 2021;
   
• Scopes of work for any contracts related to the new chemicals review process;
   
• Any OCSPP guidance under which products developed during the review of new chemicals would constitute records and how the records should be managed; and
   
• New Chemicals Review Program organization charts before and after the October 2020 reorganization.

As reported in Bergeson & Campbell, P.C.’s (B&C^®) October 28, 2021, memorandum, “House Committee Holds Hearing on ‘TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act,’” Dr. Michal Ilana Freedhoff, OCSPP Assistant Administrator, has let OIG know that OCSPP will cooperate fully with its investigation.
 

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By  Lynn L. Bergeson 

On October 1, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of the Draft FY 2022-2026 EPA Strategic Plan. 86 Fed. Reg. 54448. The draft Strategic Plan communicates EPA’s priorities and provides the roadmap for achieving its mission to protect human health and the environment. The draft Strategic Plan outlines objectives with the following goals:

• Goal 1: Tackle the Climate Crisis;
• Goal 2: Take Decisive Action to Advance Environmental Justice and Civil Rights;
• Goal 3: Enforce Environmental Laws and Ensure Compliance;
• Goal 4: Ensure Clean and Healthy Air for All Communities;
• Goal 5: Ensure Clean and Safe Water for All Communities;
• Goal 6: Safeguard and Revitalize Communities; and
• Goal 7: Ensure Safety of Chemicals for People and the Environment.

Goal 7 includes two objectives. Objective 7.1, “Ensure Chemical and Pesticide Safety,” is intended to protect the health of families, communities, and ecosystems from the risks posed by chemicals and pesticides. It includes the following long-term goals:

• By September 30, 2026, complete annually at least eight High-Priority Substance (HPS) Toxic Substances Control Act (TSCA) risk evaluations within statutory timelines compared with the fiscal year (FY) 2020 baseline of one;
• By September 30, 2026, review 90 percent of risk mitigation requirements for TSCA new chemical substances compared to the FY 2021 baseline of none;
• By September 30, 2026, renew 40 percent of expiring lead-based paint Renovation, Repair, and Painting (RRP) firm certifications within 30 days compared to the FY 2021 baseline of 36 percent;
• By September 30, 2026, complete 78 pesticide registration review cases;
• By September 30, 2026, consider the effects determinations or protections of federally threatened and endangered species for new active ingredients in 90 percent of the risk assessments supporting pesticide registration decisions for new active ingredients compared to the FY 2020 baseline of 50 percent;
• By September 30, 2026, consider the effects determinations or protections of federally threatened and endangered species in 50 percent of the risk assessments supporting pesticide registration review decisions compared to the FY 2020 baseline of 25 percent; and
• By September 30, 2026, support Agricultural Worker Protection Standard (WPS) pesticide safety training for 20,000 farmworkers annually compared with the FY 2018-2020 annual average baseline of 11,000.

Objective 7.2, “Promote Pollution Prevention,” is intended to encourage the adoption of pollution prevention and other stewardship practices that conserve natural resources, mitigate climate change, and promote environmental sustainability. It includes the following long-term goals:

• By September 30, 2026, reduce a total of 1.5 million metric tons of carbon dioxide equivalent released attributed to EPA pollution prevention grants; and
• By September 30, 2026, EPA’s Safer Choice program will certify a total of 2,300 products compared to the FY 2021 baseline of 1,950 total certified products.

According to the notice, EPA is seeking comment from individual citizens, states, tribes, local governments, industry, the academic community, non-governmental organizations (NGO), and all other interested parties. Comments are due November 12, 2021. EPA states that it “anticipates the final Strategic Plan will be submitted to Congress in February 2022.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has posted a recording of the September 22, 2021, webinar that it hosted to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. The webinar reviewed the history of the awards, the categories within the awards, eligibility requirements, and what is needed to submit a nomination. As reported in our August 27, 2021, blog item, EPA is currently accepting nominations for the 2022 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. Nominations are due December 10, 2021. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2022 nominations and make recommendations to EPA for the 2022 winners. EPA anticipates giving awards to outstanding green chemistry technologies in six categories in June 2022.

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By Lynn L. Bergeson and Carla N. Hutton
 
On October 1, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of the Draft FY 2022-2026 EPA Strategic Plan. 86 Fed. Reg. 54448. The draft Strategic Plan communicates EPA’s priorities and provides the roadmap for achieving its mission to protect human health and the environment. The draft Strategic Plan outlines objectives within the following strategic goals:

• Goal 1: Tackle the Climate Crisis;
• Goal 2: Take Decisive Action to Advance Environmental Justice and Civil Rights;
• Goal 3: Enforce Environmental Laws and Ensure Compliance;
• Goal 4: Ensure Clean and Healthy Air for All Communities;
• Goal 5: Ensure Clean and Safe Water for All Communities;
• Goal 6: Safeguard and Revitalize Communities; and
• Goal 7: Ensure Safety of Chemicals for People and the Environment.

Goal 7 includes two objectives. Objective 7.1, “Ensure Chemical and Pesticide Safety,” is intended to protect the health of families, communities, and ecosystems from the risks posed by chemicals and pesticides. It includes the following long-term goals:

• By September 30, 2026, complete at least eight High Priority Substance (HPS) Toxic Substances Control Act (TSCA) risk evaluations annually within statutory timelines compared with the fiscal year (FY) 2020 baseline of one;
• By September 30, 2026, review 90 percent of risk mitigation requirements for TSCA new chemical substances compared to the FY 2021 baseline of none;
• By September 30, 2026, renew 40 percent of expiring lead-based paint Renovation, Repair, and Painting (RRP) firm certifications within 30 days compared to the FY 2021 baseline of 36 percent;
• By September 30, 2026, complete 78 pesticide registration review cases;
• By September 30, 2026, consider the effects determinations or protections of federally threatened and endangered species for new active ingredients in 90 percent of the risk assessments supporting pesticide registration decisions for new active ingredients compared to the FY 2020 baseline of 50 percent;
• By September 30, 2026, consider the effects determinations or protections of federally threatened and endangered species in 50 percent of the risk assessments supporting pesticide registration review decisions compared to the FY 2020 baseline of 25 percent; and
• By September 30, 2026, support Agricultural Worker Protection Standard (WPS) pesticide safety training for 20,000 farmworkers annually compared with the FY 2018-2020 annual average baseline of 11,000.

Objective 7.2, “Promote Pollution Prevention,” is intended to encourage the adoption of pollution prevention and other stewardship practices that conserve natural resources, mitigate climate change, and promote environmental sustainability. It includes the following long-term goals:

• By September 30, 2026, reduce a total of 1.5 million metric tons of carbon dioxide equivalent released attributed to EPA pollution prevention grants; and
• By September 30, 2026, EPA’s Safer Choice program will certify a total of 2,300 products compared to the FY 2021 baseline of 1,950 total certified products.

According to the notice, EPA is seeking comment from individual citizens, states, tribes, local governments, industry, the academic community, non-governmental organizations (NGO), and all other interested parties. Comments are due November 12, 2021. EPA states that it “anticipates the final Strategic Plan will be submitted to Congress in February 2022.”

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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced on October 14, 2021, several actions intended to enhance scientific integrity, including establishing two internal science policy advisory councils, creating a new senior-level career position to serve as a science policy advisor to the Assistant Administrator, and making further improvements to policies and procedures. The announcement includes the following actions:

• New OCSPP Science Policy Council and New Science Policy Advisor Position: OCSPP is forming a new internal advisory group, the OCSPP Science Policy Council, to provide advisory support and recommendations on science policy and scientific integrity issues that arise within its Office of Pollution Prevention and Toxics (OPPT) and Office of Pesticide Programs (OPP). The OCSPP Science Policy Council will be chaired by a science policy advisor, a newly created position. The science policy advisor will report to the OCSPP Assistant Administrator, provide guidance on emerging science policy and scientific integrity matters, and serve as the deputy scientific integrity official for OCSPP. OCSPP states that the OCSPP Science Policy Council will provide an advisory perspective on matters related to scientific integrity; identify scientific questions that are of broad interest within OCSPP for informal review and, as appropriate, recommend a process for further addressing them; and foster informal opportunities for scientific collaboration within OCSPP. Members chosen to address specific issues or questions will be selected based on their expertise and impartiality on the issue or question, and they may include EPA experts outside of OCSPP. OCSPP notes that the group is not intended to replace or otherwise interfere with EPA’s Scientific Integrity Policy, the Scientific Integrity Official’s role, or the Inspector General’s role.
• Strengthening New Chemical Safety Reviews: According to OCSPP, as part of its broader review of policies and procedures to ensure the program effectively implements the Biden Administration’s executive orders, other directives, and principles of scientific integrity, OCSPP’s New Chemicals Division (NCD) engaged in a top-to-bottom effort to catalogue, prioritize, and improve its standard operating procedures (SOP), decision making, and recordkeeping practices related to review and management of new chemicals under the Toxic Substances Control Act (TSCA). OCSPP states that to date, NCD has inventoried and reviewed over 100 different SOPs, guidances, and science policies, and prioritized those that NCD expects to be updated over the next year. Several policy changes have already been implemented, including stopping harmful new per- and polyfluoroalkyl substances (PFAS) from entering the market and procedures to strengthen the review of new chemicals and ensure worker safety.
  • New Chemicals Advisory Committee: According to OCSPP, NCD has formed the New Chemicals Advisory Committee (NCAC) that, similar to other long-standing internal advisory bodies within OCSPP, will serve as an advisory body to review both scientific and science policy issues related to new chemical submissions subject to TSCA. If differing opinions cannot be resolved through the human health risk assessment process improvements described below, the NCAC and OCSPP Science Policy Council could provide additional opportunities for further consideration.
  • Human Health Risk Assessment Process Improvements: According to OCSPP, NCD solicited feedback from staff and implemented important changes to its process for reviewing and issuing final human health risk assessments. The new process provides additional opportunities for resolution of differing scientific opinions and invites input to the decision-making process to be provided by EPA subject matter experts outside of NCD.
  • Enhanced Recordkeeping Requirements: Proper documentation of decisions and of any differing scientific opinions of those decisions is a significant component of EPA’s Scientific Integrity Policy. OCSPP states that it has implemented some changes to its procedures to ensure improved documentation of decisions and is in the process of further review to identify additional improvements, if any, including for new chemicals human health risk assessments.
• Workplace Climate Assessment: In September 2021, with the support of an independent contractor, OCSPP launched a workplace climate assessment of the NCD to obtain feedback from employees and management about any potential workplace barriers and opportunities for organizational improvement. OCSPP states that this effort will expand to other parts of OCSPP over the coming months. OCSPP leadership will use the feedback collected to understand, evaluate, and, if necessary, make changes in its work practices and culture to promote collaboration and enhance the science used in its program decision making.

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By Lynn L. Bergeson 

On October 1, 2021, EPA announced the availability of the Draft FY 2022-2026 EPA Strategic Plan for public review and comment by November 12, 2021. EPA anticipates that the strategic plan for fiscal years (FY) 2022-2026 will be prepared in final and submitted to Congress in February 2022.

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By Lynn L. Bergeson 

On October 1, 2021, EPA announced a series of virtual meetings of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS HERA) Subcommittee to review recent progress and activities of the Chemical Safety Analytics (CSA) and Emerging Materials and Technologies (EMT) research areas. Meetings are open to the public, and EPA is accepting comments until November 3, 2021. Interested parties may also request the draft agenda or request to present at any of the meetings by November 3, 2021.

The initial meeting will be held over a two-day period via videoconference on November 4 and 5, 2021, from 12:00 p.m. to 5:00 p.m. (EDT). Registration is required by November 3, 2021. The following meetings are also scheduled:

• BOSC Deliberation Videoconference: November 18, 2021, from 11:00 a.m. to 2:00 p.m. (EST) – Registration is required by November 17, 2021.
   
• Final BOSC Deliberation Videoconference: December 10, 2021, from 11: 00 a.m. to 2:00 p.m. (EST) – Registration is required by December 9, 2021.

Meeting times are subject to change.

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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On September 22, 2021, as part of Pollution Prevention Week, the U.S. Environmental Protection Agency (EPA) recognized 33 Safer Choice Partner of the Year award winners for their achievements in design, manufacture, selection, and use of products with safer chemicals. Michal Freedhoff, Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), commented on the winners’ achievements, stating: “Today, we recognize the leadership and accomplishments of Safer Choice partners and stakeholders for their work helping consumers and commercial buyers identify products with safer chemical ingredients, without sacrificing quality or performance. Additionally, I’m excited to see that the work done by many of this year’s awardees support the Biden-Harris Administration’s goals of addressing climate change and advancing environmental justice.”
 
This year, award applicants were encouraged to demonstrate how their work with safer chemistry bolsters resilience to the impacts of climate change, promotes environmental justice, and results in cleaner air or water. In the upcoming year, EPA hopes to build on award winners’ work by expanding the Safer Choice program to make products containing safer chemicals increasingly available to underserved communities. Winners of this year’s award include small- and medium-sized companies, women-owned companies, state and local governments, non-governmental organizations (NGOs), and associations.

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