90 FR 140 pgs. 34864-34866 - Request for Nominations of
ad hoc
Expert Reviewers; Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel; Determining the Absence of Novel Proteins in the Saliva of Genetically Engineered Mosquitoes for Mosquito Control; Meetings
Type: NOTICEVolume: 90Number: 140Pages: 34864 - 34866
Pages: 34864, 34865, 34866Docket number: [EPA-HQ-OPP-2025-0756; FRL-12903-01-OCSPP]
FR document: [FR Doc. 2025-13909 Filed 7-23-25; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
[top]
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2025-0756; FRL-12903-01-OCSPP]
Request for Nominations of ad hoc Expert Reviewers; Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel; Determining the Absence of Novel Proteins in the Saliva of Genetically Engineered Mosquitoes for Mosquito Control; Meetings
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) for the review of design considerations for genetically engineered (GE) mosquitoes for mosquito control and for the review of information on the absence of novel proteins in the saliva of GE female mosquitoes. EPA currently anticipates selecting approximately 6-9 ad hoc reviewers and plans to make the list of candidates under consideration as prospective ad hoc reviewers for this review available for public comment. EPA is also announcing that a virtual public meeting of the FIFRA SAP is scheduled for November 3-5, 2025. In late August 2025, EPA plans to release the white paper to the FIFRA SAP for peer review, along with all background documents, related supporting materials, and 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 documents and provide instructions for submitting comments and registering to provide oral comments at the November 3-5, 2025, meeting.
DATES:
Submit your nominations on or before August 14, 2025.
The following is a chronological listing of the dates for the specific activities that are described in more detail under SUPPLEMENTARY INFORMATION .
August 14, 2025-Deadline for submitting all nominations to EPA.
November 3-5, 2025, 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 OCSPP-PeerReview@epa.gov.
Special accommodations: For information on meeting access or services for individuals with disabilities, and to request accommodation for a disability, please contact the Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT .
FOR FURTHER INFORMATION CONTACT:
Contact the DFO, Alie Muneer, Mission Support Division, Office of Program Support, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency; telephone number: (202) 564-6369 or call the FIFRA SAP main office at (202) 564-8450; email address: muneer.alie@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. What action is the Agency taking?
The Agency is seeking public nominations of scientific and technical experts that EPA can consider for service as ad hoc peer reviewers for the FIFRA SAP peer review on determining the absence of novel proteins in the saliva of GE female mosquitoes for mosquito control. The EPA will also be soliciting comments from these experts on the approach and methodologies presented in the white paper. This white paper will be used to inform any changes to the draft memorandum for developers which will also be released for public comment and peer review.
This document provides instructions for submitting nominations for ad hoc reviewers, requesting special accommodations for the public meeting, and accessing the materials provided to the FIFRA SAP. The EPA will publish a separate document in the Federal Register in late August 2025 to announce the availability of and solicit public comment on the white paper, 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 of ad hoc Peer Reviewers
A. What is the purpose of the FIFRA SAP?
[top] 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
B. Why is EPA seeking nominations for ad hoc peer 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 this peer review. 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 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:
1. Analytical methods for nucleic acid and protein detection
2. Molecular Biology
3. Mosquito Biology
4. Entomology
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 via email to the mailbox identified in ADDRESSES . Each nomination should include the following: Contact information for the person or entity 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 peer reviewers be subjected to an ethics review?
FIFRA SAP 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 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, 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.
F. How will EPA select the ad hoc peer reviewers?
The selection of scientists to serve as ad hoc peer 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. Interested scientists will be eligible to serve irrespective of their membership on any advisory committee to a federal department or Agency or their employment by a federal department or Agency, other than EPA. Other factors considered during the selection process include availability of the prospective candidate to fully participate in the Panel's review, ability to be hired as an EPA Special Government Employee, 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 peer 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 peer reviewers. The Agency will consider all nominations of prospective candidates for service as ad hoc peer reviewers for the FIFRA SAP that are received on or before the date listed in the DATES section of this document. However, the final selection of ad hoc peer reviewers is a discretionary function of the Agency. At this time, EPA anticipates selecting approximately 6-9 ad hoc peer reviewers for this FIFRA SAP peer review.
EPA plans to make a list of candidates under consideration as prospective ad hoc peer reviewers for this FIFRA SAP peer review available for public comment in August 2025. The list will be available in the docket at https://www.regulations.gov (docket ID number EPA-HQ-OPP-2025-0756 and on the FIFRA SAP website at https://www.epa.gov/sap.
III. Public Virtual Meeting of the FIFRA SAP
A. What is the purpose of this public meeting?
The focus of the virtual public meeting is to seek the FIFRA's SAP review and input on determining the absence of novel proteins in the saliva of GE female mosquitoes for mosquito control. This includes specific aspects of the Agency's draft memorandum that provides considerations for developers of GE mosquitoes. Feedback from this review will be considered in the development of a final memorandum.
[top] EPA intends to announce in late August 2025 in the Federal Register, the availability of and solicit public comment on the white paper, at which time EPA will provide instructions for submitting public comments for the Agency's and FIFRA SAP ad hoc peer reviewers' consideration.
B. Why did EPA develop these documents?
Genetic engineering can be used to develop modified mosquitoes for mosquito control purposes. A hallmark of GE mosquitoes is their species-specific mode-of-action, as they rely on the mating of modified male mosquitoes with wild-type females that are present in the treatment area. GE male mosquitoes express reproductive incompatibilities that are designed to reduce the number of offspring emerging from these matings ( e.g., full sterility or sex-specific sterility). When released in quantities and at frequencies sufficient to outcompete the wild-type males, fewer mosquitoes of that species emerge in the treatment area, reducing its population size over time. GE mosquitoes may be engineered to carry one or more genes that code for a pesticidal trait as well as other genes that are integral to its function; such as those coding for markers that allow for the visual detection of the introduced genetic cassette. To date, EPA has granted one Experimental Use Permit for a GE Ae. aegypti product, called OX5034, for which the company is now seeking a commercial registration. Similar GE mosquito products are currently in various stages of development.
For novel types of pesticides, such as a GE mosquito, EPA determines on a case-by-case basis the data and information needed to support the risk assessments. The base data are anchored in the established tiered biochemical data requirements at 40 CFR part 158. This information is then supplemented with product-specific information, such as the biology of the particular GE mosquito and any novel exposure potentials.
In the United States, various species of mosquitoes are known to transmit diseases that are of concern to humans, livestock, or wildlife. As such, these same species of mosquitoes may be engineered with the goal of reducing their population. For the human health assessment, determining the likelihood of the presence of GE females in the environment is important as female mosquitoes (but not males) bite humans and therefore may pose a unique intradermal route of pesticide exposure. Generally, the number of GE females in the environment is expected to be very low, however some GE females may either be incidentally released and/or emerge in the environment from matings.
EPA performs human health risk assessments and by definition risk is a function of both hazard and exposure. Eliminating the dermal exposure route by ensuring the absence of GE proteins in the saliva of GE females would therefore eliminate the overall potential for risk from these novel proteins through that route. To that end, the EPA has developed a draft memorandum that outlines genetic design considerations to minimize the likelihood for an engineered protein to be present in the saliva of GE females and to provide recommendations on specific tests to empirically determine protein absence in the saliva. The outlined considerations will reduce the likelihood of developing GE mosquitoes that produce and/or secrete novel proteins into the saliva and the analytical methods will ensure that the potential for dermal exposure, and thus risk, to GE proteins is eliminated.
EPA will be soliciting advice from the SAP on specific aspects of the Agency's draft memorandum for developers of GE mosquitoes and case studies with the intent to provide additional acceptable methodologies. If appropriate, based on the recommendations from the FIFRA SAP, EPA will update, and release the final memorandum to provide support to developers of these technologies on how EPA will utilize the data in its human health risk assessment.
C. How can I access the documents submitted for review to the FIFRA SAP?
The EPA is planning to release the white paper, the background documents, related supporting materials, and the charge questions to the FIFRA SAP in late August 2025 as described in Unit I.A. EPA will publish a separate document in the Federal Register to announce the availability of and solicit public comment on the draft documents and provide instructions for submitting comments and registering to provide oral comments. These materials will be available in the docket through https://www.regulations.gov (Docket ID No. EPA-HQ-OPP-2025-0756) and 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 August 2025. 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: July 21, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
[FR Doc. 2025-13909 Filed 7-23-25; 8:45 am]
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