[Federal Register Volume 90, Number 140 (Thursday, July 24, 2025)]
[Notices]
[Pages 34864-34866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-13909]
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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.
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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 [email protected].
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: [email protected].
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?
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
[[Page 34865]]
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 (SRB) 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
recommendations to the Agency. While there are 60 members of the SRB
who can be selected as ad hoc peer reviewers, there is often a specific
scientific expertise needed and thus, as with this FRN, the Agency is
soliciting additional ad hoc peer reviewers.
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.
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.
[[Page 34866]]
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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