2023-06038. FIFRA Scientific Advisory Panel; Examination of Microcosm/Mesocosm Studies for Evaluating the Effects of Atrazine on Aquatic Plant Communities; Request for Nominations of Ad Hoc Expert Reviewers and Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency (EPA or “Agency”) is seeking public nominations of scientific and technical experts that EPA can consider for service as ad hoc reviewers assisting the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) with the review of the Agency's reevaluation of 11 atrazine microcosm and mesocosm studies identified by the 2012 FIFRA SAP as warranting further review. EPA currently anticipates selecting approximately 8-12 ad hoc reviewers and plans to make a list of candidates under consideration as prospective ad hoc reviewers for this review available for public comment by late May 2023. EPA is also announcing that a virtual public meeting of the FIFRA SAP is being scheduled in August 2023. In July 2023, EPA plans to release the reevaluation document submitted to the FIFRA SAP for peer review, along with all background documents, related supporting materials and draft charge questions provided to the FIFRA SAP. At that time, EPA will publish a separate document in the Federal Register to announce the availability of and solicit public comment on the draft reevaluation document and provide instructions for submitting comments and registering to provide oral comments at the August 2023 meeting.

DATES:

The following is a chronological listing of the dates for the specific activities that are described in more detail under SUPPLEMENTARY INFORMATION .

April 24, 2023—Deadline for submitting all nominations to EPA.

August 8, 2023—Deadline for submitting a request for special accommodations to allow EPA time to process the request before the meeting.

August 22-24, 2023, from 10 a.m. to approximately 5:30 p.m. (ET)—The public virtual meeting will be held via a webcast platform such as “ Zoomgov.com ” and audio teleconference, and you must register to receive the links.

ADDRESSES:

Nominations: Submit your nominations via email to the Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT .

Special accommodations: For information on meeting access or services for individuals with disabilities, and to request accommodation for a disability, please contact the DFO listed under FOR FURTHER INFORMATION CONTACT .

FOR FURTHER INFORMATION CONTACT:

Contact the DFO, Tamue Gibson, Mission Support Division, Office of Program Support, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency; telephone number: [phone] or call the FIFRA SAP main office at [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. What action is the Agency taking?

The Agency is seeking public nominations of scientific and technical experts that the EPA can consider for service as ad hoc reviewers assisting the FIFRA SAP with the review of the Agency's reevaluation of 11 atrazine microcosm and mesocosm studies identified by the 2012 FIFRA SAP as warranting further review. The EPA is also announcing the scheduling of a 3-day public virtual meeting for the FIFRA SAP to review the reevaluation document. The EPA will be soliciting comments from the FIFRA SAP on the reanalysis document related to 11 microcosm and mesocosm studies examining the toxicity of atrazine to the exposed aquatic plant communities.

This document provides instructions for submitting nominations for ad hoc reviewers, requesting special accommodations for the public virtual meeting, and accessing the materials provided to the FIFRA SAP. The EPA will publish a separate document in the Federal Register in early July 2023 to announce the availability of and solicit public comment on the reevalation document, and to provide instructions for submitting comments, and registering to provide oral comments.

B. Does this action apply to me?

This action is directed to the public in general.

C. What should I consider as I submit my nominations to EPA?

1. Submitting Confidential Business Information (CBI). Do not submit CBI or other sensitive information to EPA through https://www.regulations.gov or email. If your nomination 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.

2. Tips for preparing comments. When preparing and submitting your comments, see Tips for Effective Comments at https://www.epa.gov/​dockets.

II. Nominations for Ad Hoc Reviewers

A. What is the purpose of the FIFRA SAP?

The FIFRA SAP serves as one of the primary scientific peer review mechanisms of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide independent scientific advice, information, and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on human health and the environment. The FIFRA SAP is a federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act (5 U.S.C. 10). The FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health and the National Science Foundation. FIFRA established a Science Review Board consisting of at least 60 scientists who are available to the FIFRA SAP on an ad hoc basis to assist in reviews conducted by the FIFRA SAP. As a scientific peer review mechanism, the FIFRA SAP provides comments, evaluations, and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. Members of the FIFRA SAP are scientists who have sufficient professional qualifications, including training and experience, to provide expert advice and recommendation to the Agency.

B. Why is EPA seeking nominations for ad hoc reviewers?

As part of a broader process for developing a pool of candidates for FIFRA SAP peer reviews, EPA is asking the public and stakeholder communities for nominations of scientific and technical experts that EPA can consider as prospective candidates for service as ad hoc reviewers assisting the FIFRA SAP with the peer reviews. Any interested person or organization may nominate qualified individuals for consideration as prospective candidates for this review by following the instructions provided in this document. Individuals may also self-nominate.

Those who are selected from the pool of prospective candidates will be invited to attend the public meeting and to participate in the discussion of key issues and assumptions at the meeting. In addition, they will be asked to review and to help finalize the meeting minutes.

C. What expertise is sought for this peer review?

Individuals nominated for this FIFRA SAP peer review, should have expertise in one or more of the following areas: Aquatic Plant Community Ecology; Aquatic Community Ecology; Plant Community Ecology; Algae Community Ecology; Aquatic Plant Ecology; Aquatic Toxicity; Ecotoxicity; Plant Toxicity; Algae Toxicity; and Mesocosm and Microcosm Experiments. Nominees should be scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments on the scientific issues for this review.

D. How do I make a nomination?

By the deadline indicated under DATES , submit your nomination to the DFO listed under FOR FURTHER INFORMATION CONTACT . Each nomination should include the following information: Contact information for the person making the nomination; name, affiliation, and contact information for the nominee; and the disciplinary and specific areas of expertise of the nominee.

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

FIFRA SAP members and ad hoc 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 FIFRA SAP will be asked to submit confidential financial information which shall fully disclose, among other financial interests, the candidate's employment, stocks and bonds, testimonies, and where applicable, sources of research support. EPA will evaluate the candidates' financial disclosure information 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 selection and service on the FIFRA SAP.

F. How will EPA select the ad hoc reviewers?

The selection of scientists to serve as ad hoc reviewers for the FIFRA SAP is based on the function of the Panel and the expertise needed to address the Agency's charge to the Panel. 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 Panel'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 FIFRA SAP.

Numerous qualified candidates are often identified for FIFRA SAP 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. The Agency will consider all nominations of prospective candidates for service as ad hoc reviewers for the FIFRA SAP that are received on or before the date listed in the DATES section of this document. However, final selection of ad hoc reviewers is a discretionary function of the Agency. At this time, EPA anticipates selecting approximately 8-12 ad hoc reviewers to assist the FIFRA SAP in their review of the designated topic.

The EPA plans to make a list of candidates under consideration as prospective ad hoc reviewers for this review available for public comment by late-May 2023. The list will be available in the docket at https://www.regulations.gov (Docket ID No. EPA-HQ-OPP-2023-0154) and on the FIFRA SAP website. You may also subscribe to the following listserv for alerts regarding this and other FIFRA SAP-related activities: https://public.govdelivery.com/​accounts/​USAEPAOPPT/​subscriber/​new?​topic_​id=​USAEPAOPPT_​101.T.

III. Public Virtual Meeting of the FIFRA SAP

A. What is the purpose of this public meeting?

The focus of the 3-day public virtual meeting is to seek the FIFRA SAP's input on the Agency's 2023 reevaluation of 11 atrazine microcosm and mesocosm (hereafter `cosm') studies identified at the 2012 SAP meeting as warranting further review. The Agency would like the FIFRA SAP's feedback on its evaluation of these 11 cosm studies, their potential inclusion or exclusion in the analysis, and if appropriate, whether they show an effect or no effect on the aquatic plant community.

B. Why did EPA develop this document?

The EPA participated in several FIFRA SAP meetings related to atrazine's impact on the environment ( e.g., 2003, 2007, 2009, 2012). In June 2012, the EPA presented the Problem Formulation for the Environmental Fate and Ecological Risk Assessment for Atrazine to the FIFRA SAP. That problem formulation provided an overview of atrazine use, exposure, and toxicity for assessing the ecological risk from atrazine use. One of the major considerations for the 2012 FIFRA SAP was the process that the EPA used to estimate an aquatic plant community-based concentration equivalent-level of concern (CE-LOC). The CE-LOC is a 60-day average concentration of atrazine that, when exceeded, presents a greater than 50 percent chance of negatively affecting the productivity, structure, and/or function of an aquatic plant community.

Cosm studies examining the toxicity of atrazine to aquatic plant communities are a significant part of the process to estimate the CE-LOC. Accordingly, from 2002 to 2016, the EPA considered over 70 cosm studies obtained from the open literature or submitted to the EPA. The 2012 FIFRA SAP identified 11 specific cosm studies from that dataset (Table 1, page 42-43 of the meeting report) as warranting further review (in terms of their inclusion/exclusion in the analysis or the effect/no effect determinations for specific measured endpoints) because of concerns about study design or performance flaws, as well as the interpretation of results.

In response to the 2012 FIFRA SAP, the EPA re-evaluated the 11 specific cosm studies identified by the FIFRA SAP and presented this re-evaluation in the 2013 “ Addendum to the Problem Formulation for the Ecological Risk Assessment to be Conducted for the Registration Review of Atrazine ” ( https://www.regulations.gov/​document/​EPA-HQ-OPP-2013-0266-0002) and the 2016 “ Refined Ecological Risk Assessment for Atrazine. ” ( https://www.regulations.gov/​document/​EPA-HQ-OPP-2013-0266-0315). In conducting this 2013/2016 re-evaluation, the EPA considered comments from the 2012 FIFRA SAP and the public. This re-evaluation did not result in a change in the Agency's understanding or interpretation of those 11 studies. After the issuance of the 2016 ecological risk assessment and the 2022 “Proposed Revisions to the Atrazine Interim Registration Review Decision,” the EPA received additional public comments about the 11 studies including a reminder that the EPA had stated in 2016 its intent to convene a FIFRA SAP meeting, along with renewed requests to convene a FIFRA SAP meeting regarding the studies.

The EPA is returning to the FIFRA SAP to seek feedback on the outcome of the EPA's new 2023 evaluation regarding the inclusion of the 11 studies, and if appropriate, effect/no effect determinations for specific measured endpoints from the studies that were identified by the 2012 FIFRA SAP.

C. How can I access the documents submitted for review to the FIFRA SAP?

The EPA is planning to release the reevaluation document mentioned previously and all background documents, related supporting materials, and draft charge questions provided to the FIFRA SAP by early July 2023. At that time, EPA will publish a separate document in the Federal Register to announce the availability of and solicit public comment on the draft document and provide instructions for submitting comments and registering to provide oral comments. These materials will also be available in the docket through https://www.regulations.gov (Docket ID No. EPA-HQ-OPP-2023-0154) and the FIFRA SAP website. In addition, as additional background materials become available and are provided to the FIFRA SAP, EPA will include those additional background documents ( e.g., FIFRA SAP members and consultants participating in this meeting and the meeting agenda) in the docket and on the FIFRA SAP website.

D. How can I participate in the public virtual meeting?

The public virtual meeting will be held via a webcast platform such as “ Zoomgov.com ” and audio teleconference. You must register online to receive the webcast meeting link and audio teleconference information. Please follow the registration instructions that will be announced on the FIFRA SAP website in July 2023. You may subscribe to the following listserv for alerts regarding this and other FIFRA SAP-related activities: https://public.govdelivery.com/​accounts/​USAEPAOPPT/​subscriber/​new?​topic_​id=​USAEPAOPPT_​101.T.

Authority:5 U.S.C. 10; 7 U.S.C. 136 et seq.;21 U.S.C. 301 et seq.

Dated: March 20, 2023.

Michal Freedhoff,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.