2024-04131. Formaldehyde; Draft Risk Evaluation Peer Review by the Science Advisory Committee on Chemicals (SACC); Request for Comments on Experts Being Considered for Participation as Ad Hoc Peer Reviewers

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency (EPA) is announcing the availability of and soliciting public comments on the list of candidates under consideration for selection as ad hoc peer reviewers assisting the Science Advisory Committee on Chemicals (SACC) with their peer review of the Agency's evaluation of the risks from formaldehyde being conducted to inform risk management decisions under the Toxic Substances Control Act (TSCA). The list of candidates provides the names and biographical sketches of all interested and available candidates identified from the responses to the call for nominations and other sources. Public comments on these candidates will be used to assist the Agency in selecting approximately 10–15 ad hoc peer reviewers to assist the SACC with the identified peer review.

DATES:

Submit your comments on or before March 14, 2024.

ADDRESSES:

Submit comments, identified by docket identification (ID) number EPA–HQ–OPPT–2023–0613, through the Federal eRulemaking Portal at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

The Designated Federal Official (DFO) is Tamue Gibson, Mission Support Division (7602M), Office of Program Support, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency; telephone number: (202) 564–7642; email address: [e-mail]; or call the SACC main office at (202) 564–8450.

SUPPLEMENTARY INFORMATION:

I. General Information

A. What action is the Agency taking?

The Agency is seeking public comments on scientific and technical experts that EPA is considering for service as ad hoc peer reviewers assisting the SACC with the peer review of the Agency's evaluation of the risks from formaldehyde being conducted to inform risk management decisions under TSCA. The Office of Pollution Prevention and Toxics (OPPT) collaborated with the Office of Pesticide Programs (OPP) to develop hazard assessments for human and ecological health. EPA expects to ask the SACC to consider and review these joint hazard assessments in addition to the OPPT exposure and risk characterizations. This SACC peer review is in addition to prior external peer reviews by the National Academies of Science, Engineering, and Medicine (NASEM), the EPA's Human Studies Review Board (HSRB) and SACC peer reviews of related scientific issues. The Agency is leveraging these peer reviews to support further development of the risk evaluation of formaldehyde. For additional information, please see the Agency's request for nominations of ad hoc expert reviewers that appeared in the Federal Register of December 26, 2023 (88 FR 88910 (FRL–11608–01–OCSPP)).

B. What is the Agency's authority for taking this action?

EPA established the SACC in 2016 in accordance with TSCA, 15 U.S.C. 2625(o), to provide independent advice and expert consultation with respect to the scientific and technical aspects of issues relating to the implementation of TSCA. The SACC operates in accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C. 10, and supports activities under TSCA, 15 U.S.C. 2601 et seq., the Pollution Prevention Act (PPA), 42 U.S.C. 13101 et seq., and other applicable statutes.

C. Does this action apply to me?

This action is directed to the public in general and may be of particular interest to those involved in the manufacture, processing, distribution, and disposal of the subject chemical substance, and/or those interested in the assessment of risks involving chemical substances and mixtures regulated under TSCA.

D. What should I consider as I prepare my comments for EPA?

Do not electronically submit any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Copyrighted material will not be posted without explicit permission of the copyright holder. Members of the public should also be aware that personal contact information, if included in any written comments, may be posted on the internet at https://www.regulations.gov. If your comment contains any information that you consider to be CBI or otherwise protected, please contact the DFO listed under FOR FURTHER INFORMATION CONTACT to obtain special instructions before submitting that information.

E. How can I stay informed about SACC activities?

You may subscribe to the following listserv for alerts regarding this and other SACC-related activities: https://public.govdelivery.com/​accounts/​USAEPAOPPT/​subscriber/​new?​topic_​id=​USAEPAOPPT_​101.

II. Background

EPA is planning this SACC peer review of the Agency's evaluation of the risks from formaldehyde being conducted to inform risk management decisions under TSCA. OPPT collaborated with OPP to develop hazard assessments for human and ecological health. EPA expects to ask the SACC to consider and review these joint hazard assessments in addition to the OPPT exposure and risk characterizations. This SACC peer review is in addition to prior external peer reviews by the National Academies of Science, Engineering, and Medicine (NASEM), the EPA's Human Studies Review Board (HSRB) and SACC peer reviews of related scientific issues. The Agency is leveraging these peer reviews to support further development of the risk evaluation of formaldehyde. The TSCA risk evaluation of formaldehyde is expected to comprise several modules ( i.e., human health hazard, ecological hazard, release and exposure assessments) and two risk assessment documents—the ecological risk assessment and the human health risk assessment. As part of the TSCA risk evaluation for formaldehyde, OPPT is assessing formaldehyde conditions of use (COUs; e.g., composite wood products, plastics, rubber, toys, and various adhesives and sealants).

Recommendations from the formaldehyde SACC review will be considered in the development of the TSCA risk evaluation and may inform other EPA efforts related to the assessment and regulation of formaldehyde. The Agency will be seeking SACC review of its data analyses and methodologies relevant to human health hazard and exposure analyses that have not been previously peer reviewed. For additional information, please see the Federal Register notice of December 26, 2023 (88 FR 88910).

III. Request for Comments on the Candidates List

A. Will ad hoc reviewers be subjected to an ethics review?

EPA is currently seeking public comments on all interested and available candidates, without prescreening for ethics concerns. However, SACC members and ad hoc peer reviewers are subject to the provisions of the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR part 2635, conflict of interest statutes in title 18 of the United States Code and related regulations. In anticipation of this requirement, prospective candidates for service on the SACC will be asked to submit confidential financial information which shall fully disclose, among other financial interests, the candidate's employment, stocks and bonds, and where applicable, sources of research support. EPA will evaluate the candidates' financial disclosure forms to assess whether there are financial conflicts of interest, appearance of a loss of impartiality, or any prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidate is considered further for service on the SACC.

B. How will EPA select the ad hoc reviewers?

The selection of scientists to serve as ad hoc peer reviewers for the SACC is based on the function of the Committee and the expertise needed to address the Agency's charge to the Committee. No interested scientists shall be ineligible to serve by reason of their membership on any other advisory committee to a federal department or agency or their employment by a federal department or agency, except EPA. Other factors considered during the selection process include availability of the prospective candidate to fully participate in the Committee's reviews, absence of any conflicts of interest or appearance of loss of impartiality, independence with respect to the matters under review, and lack of bias. Although financial conflicts of interest, the appearance of loss of impartiality, lack of independence, and bias may result in non-selection, the absence of such concerns does not assure that a candidate will be selected to serve on the SACC.

Numerous qualified candidates are often identified for SACC reviews. Therefore, selection decisions involve carefully weighing a number of factors including the candidates' areas of expertise and professional qualifications, and achieving an overall balance of different scientific perspectives across reviewers.

Authority:15 U.S.C. 2625(o); 5 U.S.C 10.

Dated: February 23, 2024.

Michal Freedhoff,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.