[Federal Register Volume 90, Number 160 (Thursday, August 21, 2025)]
[Notices]
[Pages 40829-40831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-15950]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2025-0756; FRL-12903-02-OCSPP]
FIFRA Scientific Advisory Panel (SAP); Determining the Absence of
Novel Proteins in the Saliva of Genetically Engineered Mosquitoes for
Mosquito Control; Notice of Availability, and Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or ``Agency'') is
announcing the availability of and soliciting public comment on
materials that are being submitted to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP)
for peer review on ``Determining the Absence of Novel Proteins in the
Saliva of Genetically Engineered Mosquitoes for Mosquito Control.'' The
white paper, charge questions, background documents, and related
supporting materials are available for public review and comment. The
FIFRA SAP will consider and review the documents at a 3-day virtual
public meeting that was previously announced in the Federal Register of
July 24, 2025. The virtual public meeting will be held on November 3-5,
2025, via a webcast platform such as ``Zoomgov.com'' and audio
teleconference.
DATES: The following is a chronological listing of the dates for the
specific activities that are described in more detail under
SUPPLEMENTARY INFORMATION.
September 22, 2025--Deadline to submit written comments on the peer
review documents (white paper, charge questions, background documents,
and related supported materials).
October 24, 2025--Deadline to submit a request for special
accommodations to allow sufficient time for EPA to process the request
before the meeting.
October 27, 2025 (12:00 p.m. ET)--Deadline to register to be listed
on the meeting agenda to make oral comments during the virtual meeting.
October 30, 2025--Deadline to submit a written version of oral
comments that will be made during the virtual meeting.
November 3-5, 2025--FIFRA SAP public virtual meeting.
November 5, 2025--Deadline for those not making oral comments to
register to receive the links to observe the meeting.
ADDRESSES:
To comment: Submit written comments, identified by docket
identification (ID) number EPA-HQ-OPP-2025-0756, through https://www.regulations.gov. Follow the online instructions for submitting
comments. 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 from the copyright holder. Members
of the public should also be aware that personal information included
in any written comments may be posted on the internet at https://www.regulations.gov. Additional information on commenting or visiting
the docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.
To register for the meeting: For information on how to register and
access the virtual public meeting, please refer to the FIFRA SAP
website at https://www.epa.gov/sap. EPA intends to announce
registration instructions on the FIFRA SAP website by October 2025. You
may also subscribe to the following listserv for alerts regarding this
and other FIFRA SAP-related activities at https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101.T.
To request special accommodations: For information on 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: 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 the main office number: (202) 564-8450; email
address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
EPA is announcing the availability of and soliciting public comment
on the white paper, entitled ``Determining the Absence of Novel
Proteins in the Saliva of Genetically Engineered Mosquitoes for
Mosquito Control,'' charge questions, background documents, and related
supporting materials, which are available in the docket. EPA will be
soliciting comments from the FIFRA SAP on the Agency's draft memorandum
for developers of GE mosquitoes and case studies with the intent to
provide additional acceptable
[[Page 40830]]
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.
This document provides instructions for accessing the materials
provided to the FIFRA SAP, submitting written comments, and registering
to provide oral comments and attend the virtual meeting.
B. What is the Agency's authority for taking this action?
The FIFRA SAP is a federal advisory committee established in 1975
under FIFRA, 7 U.S.C. 136 et seq., to provide independent scientific
advice to EPA on health and safety issues related to pesticides. The
FIFRA SAP operates in accordance with the Federal Advisory Committee
Act (FACA), 5 U.S.C. 10, and supports activities under FIFRA, the
Federal Food, Drug, and Cosmetic Act (FFDCA) and other applicable
statutes.
C. Does this action apply to me?
This action is directed to the public in general. This action may
be of interest to persons who are or may be required to conduct testing
of chemical substances under the FFDCA and FIFRA. Since other entities
may also be interested, the Agency has not attempted to describe all
the specific entities that may be affected by this action.
D. What should I consider as I submit my comments to EPA?
1. Submitting Confidential Business Information (CBI)
Do not submit CBI or other sensitive information electronically to
EPA through https://www.regulations.gov or email. To include
information in your comment that you consider to be CBI or otherwise
protected, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT for instructions before submitting CBI or other sensitive
information.
2. Tips for Preparing Your Comments
When preparing and submitting your comments, see the commenting
tips at https://www.epa.gov/dockets/commenting-epa-dockets. See also
the instructions in Unit III.
II. Background
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 (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.
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. 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. 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.
While 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. As such, these same
species of mosquitoes may be engineered with the goal of reducing their
population. For the human health risk 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. Determination on whether a
protein is present in the saliva of female mosquitoes informs the
likelihood of exposure, and thus overall risk, of humans to these
proteins through the intradermal route. To that end, 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.
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.
III. Virtual Public Meeting of the FIFRA SAP
A. How can I access the documents submitted for review to the FIFRA
SAP?
These documents, including the white paper, charge questions, draft
memorandum, background documents, and related supporting materials,
mentioned in Unit II.B provided to the FIFRA SAP are available in the
docket at https://www.regulations.gov (docket
[[Page 40831]]
ID No. EPA-HQ-OPP-2025-0756) and the FIFRA SAP website at https://www.epa.gov/sap. 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 the meeting and the meeting agenda) in the
docket and accessible through the FIFRA SAP website.
After the public meeting, the FIFRA SAP will prepare meeting
minutes and a final report document summarizing its recommendations to
the EPA. This document will also be posted in the docket and made
available at regulations.gov and the FIFRA SAP website.
B. How can I provide comments for the FIFRA SAP's consideration?
To ensure proper receipt of comments, it is imperative that you
identify docket ID No. EPA-HQ-OPP-2025-0756 in the subject line on the
first page of your comments and follow the instructions in this unit.
1. Written Comments
The Agency encourages written comments for this meeting be
submitted by the deadlines set in the DATES section of this document
and as described in the ADDRESSES section of this document.
2. Oral Comments
To request time to present oral comments during the virtual public
meeting, you must register online by the deadlines set in the DATES
section of this document. Oral comments during the virtual public
meetings are limited to five minutes unless arrangements have been made
with the DFO, within the constraints of the meeting agenda, prior to
noon (12:00 p.m. ET), October 27, 2025. In addition, each speaker
should submit a written copy of their oral comments and any supporting
materials (e.g., presentation slides) to the DFO prior to the meeting
for distribution to the FIFRA SAP by the deadline set in the DATES
section of this document.
C. How can I participate in the virtual public meeting?
To participate in the virtual public meeting, you must register
online to receive the webcast and streaming service meeting links and
audio teleconference information for the meeting. Online registration
will be available approximately one month prior to the meeting and will
remain open through the end of the meeting. To make oral comments
during the meeting, follow the instructions in this document.
Authority: 5 U.S.C. 10; 7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq.
Dated: August 15, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and
Pollution Prevention.
[FR Doc. 2025-15950 Filed 8-20-25; 8:45 am]
BILLING CODE 6560-50-P