Request for Public Nominations of Experts To Review the New Chemicals Collaborative Research Program

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The U.S. Environmental Protection Agency (EPA) is seeking nominations for technical experts to serve as Special Government Employees (SGEs) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). Submission of nominations will be made via the BOSC website at: https://www.epa.gov/bosc.

DATES:

Nominations should be submitted by June 30, 2022, per instructions below.

FOR FURTHER INFORMATION CONTACT:

Any member of the public needing additional information regarding this Notice and Request for Nominations may contact Mr. Tom Tracy, Office of Science Policy, Office of Research and Development, Mail Code B343-01, 109 T.W. Alexander Drive, Research Triangle Park, NC 27711; via phone/voice mail at: (919) 541-4334; or via email at: tracy.tom@epa.gov. General information concerning the BOSC can be found at the following website: https://www.epa.gov/bosc.

SUPPLEMENTARY INFORMATION:

Background

The BOSC is a chartered Federal Advisory Committee established by the EPA to provide independent scientific and technical peer review, advice, consultation, and recommendations about ORD. As a Federal Advisory Committee, the BOSC conducts business in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2) and related regulations.

The BOSC is comprised of an Executive Committee and two supporting subcommittee(s): Social and Community Science, and Climate Change. Please visit https://www.epa.gov/aboutepa/about-office-research-and-development-ord to learn more about ORD's research programs.

Members of the BOSC constitute a distinguished body of non-EPA scientists, engineers, and economists who are experts in their respective fields. We are seeking SGEs to serve as special experts to assist the BOSC in the review of the New Chemicals Collaborative Research Program in the Fall of 2022.

The BOSC will be evaluating the Office of Research and Development (ORD)'s draft Strategic Research Action Plans Fiscal Years 2023-2026 in Fall 2022. The Fall 2022 meeting will provide a more in-depth evaluation of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program (See Output CSS.8.4: Innovative science to support new chemicals evaluation in the draft StRAP for Chemical Safety and Sustainability) and associated research plan ( https://www.regulations.gov/document/EPA-HQ-OPPT-2022-0218-0004 ). An additional draft document will be provided that summarizes technical details of the research plan. ORD in partnership with the Office of Chemical Safety and Pollution Prevention (OCSPP) are proposing to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. The results of the effort are expected to bring innovative science to new chemical reviews, modernize the approaches used, and increase the transparency of the information underpinning the human health and ecological risk assessment process. Key areas proposed in the TSCA New Chemicals Collaborative Research Program include:

• Updating OCSPP's category and read-across approach which uses data from structurally similar chemicals to determine potential risks from new chemicals when data for those chemicals are lacking. This research effort will increase the efficiency of new chemical reviews by identifying appropriate analogues for read across and promoting the use of the best available data to protect human health and the environment. The existing category approach in use dates to 2010 and is available here: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemical-categories-used-review-new .

• Digitizing and consolidating information on chemicals to include data and studies that currently only exist in hard copy or in disparate TSCA databases. The information will be combined with publicly available sources to expand the amount of information available, enhancing chemical reviews and enabling efficient sharing of chemical information across EPA. Safeguards for TSCA confidential business information will be maintained as appropriate in this process. Data curation in public databases will proceed and where possible these databases will be made interchangeable with International Uniform Chemical Information Database (IUCLID) formats.

• Updating and augmenting the models used for predicting a chemical's physical-chemical properties and environmental fate/transport, hazard, exposure (including functional use predictions), and toxicokinetics to provide a suite of models to be used for new chemicals assessments. The goal of this effort is to update the models to reflect the best available science, increase transparency, and establish a process for updating these models as science evolves. The predictive models currently in use by OCSPP for new chemical evaluation are available here: https://www.epa.gov/tsca-screening-tools .

• Exploring ways to integrate and apply new approach methods (NAMs) in new chemicals assessments, thereby reducing the use of animal testing. As this effort evolves, the goal is to develop a suite of accepted, fit-for-purpose NAMs that could be used by external stakeholders for data submissions under TSCA as well as informing and expanding new chemical categories.

• Developing a decision support tool that integrates the various information streams specifically used for new chemical risk assessments. The decision support tool will more efficiently integrate all the data streams ( e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made. Simply put, this will facilitate the tracking of the new chemicals program decisions and provide consistency within and across chemistries.

EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and tribal) and non-government organizations, and other relevant interest areas. EPA values and welcomes diversity. All qualified candidates are encouraged to apply regardless of gender, race, disability, or ethnicity.

Expertise Sought

The EPA invites nominations of individuals to serve as SGEs with expertise or extensive experience in the following scientific disciplines and topic areas as they relate to human health and the environment:

• Using data to develop predictive models and use of predictive models in data poor environment

○ Read across and analogue selection

○ Chemical structures and cheminformatics

○ Quantitative Structure-Activity Relationships (QSAR)

• Development, implementation, and validation of new approach methods (NAMs). Relevant expertise may include:

○ Veterinary pathology or comparative physiology for perspective on relevance of laboratory animals for predicting human outcomes

○ Reference data curation to support validation

• Computational modeling, bioinformatics, and/or statistics
• Toxicokinetics, Physiologically-based pharmacokinetic models (PBPK), and in vitro to in vivo extrapolation (IVIVE)
• Systems biology

• Human health and ecological risk assessment

Exposure modeling and/or assessment, including near-field and far-field sources

• Knowledge of TSCA
• Environmental fate of chemicals

Selection Criteria

Nominations will be evaluated on the basis of several criteria including: (a) Demonstrated scientific and/or technical credentials and disciplinary expertise, knowledge, and experience in relevant fields; (b) availability to serve and willingness to commit time to the committee (approximately one to three meetings per year both by teleconferences and possibly face-to-face meetings); (c) absence of financial conflicts of interest; (d) absence of an appearance of a lack of impartiality; (e) demonstrated ability to work constructively and effectively on committees; and (f) background and experiences that would contribute to the diversity of viewpoints including workforce sector, geographical location, social, cultural, and educational backgrounds, and professional affiliations.

Process and Deadline for Submitting Nominations

Any interested person or organization may nominate qualified persons to be considered for appointment. Nominations should be submitted via the BOSC website at: https://www.epa.gov/bosc. Nominations should be submitted no later than June 30, 2022. To receive full consideration, nominations should include all the information requested. EPA's nomination form requests: Contact information about the person making the nomination; contact information about the nominee; the disciplinary and specific areas of expertise of the nominee; the nominee's curriculum vita and/or resume; and additional information that would be useful for considering the nomination such as background and qualifications ( e.g., current position, educational background, expertise, research areas), experience relevant to the areas mentioned above, service on other advisory committees and professional societies, and availability to participate as an SGE. Persons having questions about the nomination procedures, or who are unable to submit nominations through the BOSC website, should contact Mr. Tom Tracy, as indicated above under FOR FURTHER INFORMATION CONTACT section of this notice.