By Lynn L. Bergeson and Carla N. Hutton
 
On February 15, 2023, the U.S. Environmental Protection Agency (EPA) requested nominations for technical experts to serve as Special Government Employees (SGE) on a review panel under the authority of the Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). 88 Fed. Reg. 9880. EPA states that selected experts will review ORD’s draft documents detailing scientific studies supporting the development of transcriptomic-based toxicity values and their implementation as a new EPA Transcriptomic Assessment Product (ETAP). According to EPA, the ETAP is a proposed ORD assessment product that uses a standardized short-term in vivo study design and data analysis procedures to develop transcriptomic-based toxicity values for data-poor chemicals. Draft documents will be provided in the BOSC docket prior to the meeting for an in-depth evaluation of:

• Literature review and scientific studies supporting the development of transcriptomic points of departure from short-term in vivo studies;
• Derivation of transcriptomic toxicity values for chronic toxicity;
• Incorporation of transcriptomic toxicity values into a new standardized assessment product that is intended for data-poor chemicals; and
• Example application of the ETAP to a data-poor per- and polyfluoroalkyl substance (PFAS).

According to EPA, the review of the draft documents detailing underlying scientific studies and implementation of ETAP by the BOSC is being performed in close coordination with a separate BOSC review of a value-of-information (VOI) analysis comparing the ETAP with traditional human health assessment practices. EPA states that the VOI analysis is intended to evaluate the public health and economic trade-offs associated with the timeliness, uncertainty, and costs of the different toxicity evaluation and assessment approaches.

The review will take place between April and July 2023. Nominations are due March 3, 2023.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on October 11, 2022, that the Office of Research and Development’s (ORD) Board of Scientific Counselors (BOSC) will review the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 61313. The meeting will be held October 24-25, 2022, via videoconference. Attendees must register by October 23, 2022. Comments must be received by October 23, 2022, to be considered by BOSC. EPA states that requests for the draft agenda or to make a presentation at the meeting will be accepted until October 23, 2022.
 
BOSC is a federal advisory committee that provides advice and recommendations to ORD on technical and management issues of its research programs. The meeting agenda and materials will be posted on BOSC’s website. According to the Federal Register notice, proposed agenda items for the meeting include, but are not limited to, review of the New Chemicals Collaborative Research Program.
 
As reported in our March 14, 2022, memorandum on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. On April 20-21, 2022, EPA held a virtual public meeting to provide an overview of the program and give stakeholders an opportunity to provide input. EPA has posted the meeting materials in the online docket. A summary of the meeting is available in our April 22, 2022, memorandum.

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On May 4-5, 2022, the U.S. Environmental Protection Agency (EPA) Board of Scientific Counselors (BOSC) Executive Committee will meet to review the Office of Research and Development’s (ORD) six Strategic Research Action Plans (StRAP) for fiscal years (FY) 2023-2026. The meetings are open to the public. 87 Fed. Reg. 23861. BOSC will consider comments on the draft StRAPs that are submitted by May 3, 2022. Requests for the draft agenda or making a presentation at the meeting will be accepted until May 3, 2022. The meeting is open to the public. Registration is required.

The draft StRAPs outline the leading-edge research strategies necessary to provide the scientific foundation for EPA to execute its mandate to protect human health and the environment. ORD organized the StRAPs around each of its six National Research Programs and developed them through a series of listening sessions, workshops, and consultations with EPA partners; state, tribal, and local partners; and community groups. EPA plans to release the final StRAPs later this year. The draft StRAPs for ORD’s six National Research Programs include:

• Air, Climate, and Energy (ACE);
• Chemical Safety for Sustainability (CSS);
• Health and Environmental Risk Assessment (HERA);
• Homeland Security (HS);
• Safe and Sustainable Water Resources (SSWR); and
• Sustainable and Healthy Communities (SHC).

According to the draft CSS StRAP, “[a] key issue with current chemical safety assessment is that traditional approaches have been unable to keep pace with innovations in chemical design, synthesis, and use.” The draft StRAP states that CSS will continue to:

• Develop the science needed to reduce, refine, and replace vertebrate animal testing consistent with EPA policies;
• Accelerate the pace of chemical assessment to enable its partners to make informed and timely decisions concerning the potential impacts of environmental chemicals on human health and the environment; and
• Provide leadership to transform chemical testing, screening, prioritization, and risk assessment practices.

While continuing its core research activities, ORD envisions that CSS will further incorporate cross-cutting research priorities. To be effective over the course of the StRAP, CSS will not only develop robust scientific data and innovative tools, but also interpretative frameworks.

According to the draft HERA StRAP, HERA “develops a portfolio of fit-for-purpose human health or environmental assessment products and assessment-related research to meet EPA’s wide-ranging statutory and regulatory needs.” HERA identifies, evaluates, and integrates existing and emerging information from diverse scientific disciplines to characterize human or environmental hazards. The draft StRAP states that HERA advances the science and practice of assessment through methods development, case studies, models, and tools that are tethered to assessment needs.

HERA “will continue as a leader in innovating and applying systematic review methods, including evidence integration and mapping.” According to the draft StRAP, areas of new or increasing emphasis will incorporate research relevant to children’s environmental health, equity and environmental justice, climate change, and cumulative risk. The draft StRAP states that HERA’s strategic direction “culminates in a program structured to facilitate efficient construction and production of high-quality, transparent, state-of-the-science assessment research that maximizes resources to address priority statutory, regulatory, and programmatic needs.”

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