Modernizing the Approach to the Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) Oversight of Certain Products; Notice of Public Meeting and Request for Comments, 11434-11436 [2023-03739]
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11434
Federal Register / Vol. 88, No. 36 / Thursday, February 23, 2023 / Notices
listed at the end of each application
summary.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
lotter on DSK11XQN23PROD with NOTICES1
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
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.
II. Registration Applications
EPA has received applications to
register pesticide products containing
active ingredients not included in any
currently registered pesticide products.
Pursuant to the provisions of FIFRA
section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA
is hereby providing notice of receipt and
opportunity to comment on these
applications. Notice of receipt of these
applications does not imply a decision
by the Agency on these applications.
For actions being evaluated under EPA’s
public participation process for
registration actions, there will be an
additional opportunity for public
comment on the proposed decisions.
VerDate Sep<11>2014
17:12 Feb 22, 2023
Jkt 259001
Please see EPA’s public participation
website for additional information on
this process (https://www2.epa.gov/
pesticide-registration/publicparticipation-process-registrationactions).
Notice of Receipt—New Active
Ingredients
File Symbols: 1021–EITE, 1021–EIAO,
1021–EIAI, 1021–EITR, 1021–EITN.
Docket ID number: EPA–HQ–OPP–
2022–0772. Applicant: McLaughlin
Gormley King Company, d/b/a MGK,
7325 Aspen Lane N Minneapolis, MN
55428. Product names: Sabadilla 10%
Alkaloid Extract; MGK Formula 31422
Aerosol; MGK Formula 31421 (RTU);
MGK Formula 31731 (RTU); MGK
Formula 3159 [10%, 0.1%, 0.1%, 0.1%,
4.2%]. Active ingredient: Cevadine
Mixture with Veratridine. Proposed
classification/Use: Outdoor, non-food
use; spot, crack and crevice. Contact:
RD.
File Symbol: 7001–TTIL. Docket ID
number: EPA–HQ–OPP–2022–0642.
Applicant: JR Simplot Company, 16777
Howland Road, Lathrop, CA 95330.
Product name: No MasTM. Active
ingredient: Herbicide—ferrous sulfate
heptahydrate at 100%. Proposed use:
Non-food use for moss control on turf,
lawns, and base of tree trunks. Contact:
BPPD.
File Symbol: 29964–GE. Docket ID
number: EPA–HQ–OPP–2022–0989.
Applicant: Pioneer Hi-Bred
International 8325 NW 62nd Avenue
Johnston, IA 50131, USA. Product
name: DP910521 Maize Insect
Protected, Herbicide-Tolerant Corn.
Active ingredient: Insecticide—Bacillus
thuringiensis Cry1B.34 protein and the
genetic material necessary (PHP79620
T–DNA) for its production in corn event
DP-91;521–2 at 0.04%. Proposed use:
Plant-Incorporated-Protectant (PIP) for
use in maize. Contact: BPPD.
File Symbol: 29964–GG. Docket ID
number: EPA–HQ–OPP–2023–0018.
Applicant: Pioneer Hi-Bred
International, Inc., 7100 NW 62nd
Avenue, P.O. Box 1000, Johnston, Iowa,
50131. Product name: DAS1131 Maize
Insect Protected, Herbicide-Tolerant
Corn. Active ingredient: Insecticide—
Bacillus thuringiensis Cry1Da2 protein
and the genetic material necessary
(PHP88492 T–DNA) for its production
in corn event DAS-;1131–3. Proposed
use: Plant-Incorporated-Protectant (PIP)
for use in maize. Contact: BPPD.
File Symbol: 91163–E. Docket ID
number: EPA–HQ–OPP–2022–0849.
Applicant: Texas Corn Producers Board,
4205 N Interstate 27, Lubbock, Texas
79403. Product name: FourSure. Active
ingredients: Fungicides—Aspergillus
PO 00000
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Fmt 4703
Sfmt 4703
flavus strains TC16F, TC35C, TC38B,
and TC46G at 0.00024% each. Proposed
use: For application to corn to displace
aflatoxin-producing strains of
Aspergillus flavus. Contact: BPPD.
File Symbol: 97144–G. Docket ID
Number: EPA–HQ–OPP–2023–0002.
Application: Reliox Corporation, 8475
Western Way, Suite 155, Jacksonville,
FL 32256. Product Name: Whiff! (with
ReliOx Resin). Active Ingredient:
Antimicrobial—Styrene divinylbenzene
and ethylstyrene copolymer,
chloromethyl trimethylamine
functionalized in the tribromide form
(Reliox resin) at 100% nominal
concentration. Proposed Use:
Disinfectant and sanitizer on hard, nonporous surfaces in commercial settings.
Contact: Michael Varco, AD.
Authority: 7 U.S.C. 136 et seq.
Dated: February 16, 2023.
Delores Barber,
Director, Information Technology and
Resources Management Division, Office of
Program Support.
[FR Doc. 2023–03748 Filed 2–22–23; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2023–0103; FRL–10689–01–
OCSPP]
Modernizing the Approach to the
Environmental Protection Agency
(EPA) and Food and Drug
Administration (FDA) Oversight of
Certain Products; Notice of Public
Meeting and Request for Comments
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The U.S. Environmental
Protection Agency (EPA)’s Office of
Chemical Safety and Pollution
Prevention (OCSPP) is co-hosting a
virtual public meeting with the U.S.
Food and Drug Administration (FDA)’s
Center of Veterinary Medicine (CVM) on
March 22, 2023. Additionally, EPA has
opened a docket for the agencies to
receive public comment on their current
approach to the oversight of various
products regulated as either pesticides
by EPA or new animal drugs by FDA,
with a focus on parasite treatment
products applied topically to animals
and in genetically engineered pest
animals for use as pest control tools.
The agencies are also announcing the
availability of and soliciting comment
on a document entitled,
‘‘WHITEPAPER: A Modern Approach to
EPA and FDA Product Oversight’’ that
describes the current challenges and
SUMMARY:
E:\FR\FM\23FEN1.SGM
23FEN1
Federal Register / Vol. 88, No. 36 / Thursday, February 23, 2023 / Notices
highlights the potential benefits of a
modernized approach for oversight of
these products. EPA and FDA are
considering how best to update their
respective oversight responsibilities for
specific products in an efficient and
transparent manner and in alignment
with each agency’s expertise, with the
goal of improving protection of human,
animal, and environmental health. The
purpose of the public comment period
and virtual public meeting is to obtain
feedback from stakeholders on the
whitepaper and ideas for modernizing
EPA and FDA’s approach to product
oversight.
lotter on DSK11XQN23PROD with NOTICES1
DATES:
Virtual Public Meeting: March 22,
2023, from 1:00 p.m. to 4:00 p.m. (EDT).
Registration to attend the virtual public
meeting is required on or before March
15, 2023. See the additional details and
instructions for registration that appear
in Unit III.
Written Comments: Submit your
comments on or before April 24, 2023.
As described in Unit III., you may also
register to make oral comments during
the virtual public meeting.
Special accommodations: Requests
for special accommodations should be
submitted as instructed under
ADDRESSES on or before March 15, 2023,
to allow EPA and FDA time to process
these requests.
ADDRESSES:
Virtual Public Meeting: You must
register online to receive the webcast
meeting link and audio teleconference
information on or before the date set in
the DATES section. Please follow the
registration instructions that is available
through a link on the Office of Pesticide
Programs (OPP) website available at:
https://www.epa.gov/pesticides. For
additional instructions, see Unit III.
Written Comments: Submit written
comments, identified by docket
identification (ID) No. EPA–HQ–OPP–
2023–0103, through the Federal
eRulemaking Portal at https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not electronically submit any
information you consider Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. Additional
information on commenting or visiting
the docket, along with more information
about dockets generally, is available at
https://www.epa.gov/dockets.
Special accommodations: For
information on access or services for
individuals with disabilities, and to
request accommodation for a disability,
please contact Paul Di Salvo, listed
VerDate Sep<11>2014
17:12 Feb 22, 2023
Jkt 259001
under FOR FURTHER INFORMATION
CONTACT.
Paul
Di Salvo, Office of Chemical Safety and
Pollution Prevention, Registration
Division (7505T), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
telephone number: (202) 566–2597;
email address: disalvo.paul@epa.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Executive Summary
A. Does this action apply to me?
This notice is directed to the general
public and may be of specific interest to
persons (e.g., industry, nongovernmental organizations (NGOs),
animal owners, veterinarians, and
academia) who are or may be interested
in regulation of parasite treatment
products applied topically to animals or
in genetically engineered pest animals
for use as pest control tools. Because
other entities may also be interested in
this notice, the agencies have not
attempted to describe all entities that
may be interested in this subject.
B. Where can I access information about
this meeting?
Information about this meeting is
available through a link on the OPP
website available at: https://
www.epa.gov/pesticides. Supporting
materials are available in the docket for
this meeting, identified by docket ID No.
EPA–HQ–OPP–2023–0103, at https://
www.regulations.gov.
C. What should I consider as I prepare
my comments?
1. Submitting CBI. Do not submit CBI
information through https://
www.regulations.gov or email. If your
comments contain any information that
you consider to be CBI or otherwise
protected, please contact the individual
listed under FOR FURTHER INFORMATION
CONTACT to obtain special instructions
before submitting your comments.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see Tips for Effective
Comments at https://www.epa.gov/
dockets.
II. Background
A. Why are EPA and FDA hosting this
public meeting and soliciting public
comment?
Currently, EPA and FDA determine
regulatory oversight of pesticides and
new animal drugs based on the rationale
described in a Memorandum of
Understanding (MOU) between the
agencies signed in 1971 and revised in
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
11435
1973. Since that time, pesticide and
animal drug technologies—and both
agencies’ understanding of these
technologies—have evolved.
For example, parasite treatment
products applied topically to animals
generally are regulated by EPA if they
remain on the skin to control only
external parasites (e.g., fleas, ticks) and
by FDA if they are absorbed
systemically into the bloodstream to
control internal parasites (e.g., intestinal
worms). The agencies now understand
that many of the topically administered
products currently regulated by EPA do
not remain on the skin and are actually
absorbed into the bloodstream,
highlighting challenges with the current
approach and raising different safety
concerns than originally anticipated.
Additionally, genetically engineered
(‘‘GE’’) pest animals, which are gaining
interest as a pest control tool, were not
envisioned 50 years ago when the
original regulatory approach was
developed. As agreed in the 2016
National Strategy for Modernizing the
Regulatory System for Biotechnology
Products, EPA and FDA have
considered how to update their
respective responsibilities with the goal
of developing an efficient, transparent,
and predictable approach for overseeing
GE insects. Recently, Executive Order
14081, issued September 12, 2022, has
further directed the agencies to improve
the clarity and efficiency of the
regulatory process for biotechnology
products, underscoring the need for
continued coordination between the
agencies on biotechnology.
The agencies’ current approach to
determining whether EPA or FDA is the
appropriate regulator of certain products
does not effectively reflect or
accommodate scientific advancement,
and it has become clear in some cases
that the current approach has resulted
in misalignment between product
characteristics and the agency better
equipped to regulate the product. A
modernized approach would ensure that
the oversight of these products better
aligns with each agency’s expertise,
accounts for scientific advancement,
avoids redundancy, better protects
animal health and safety, and improves
regulatory clarity for regulated entities,
animal owners, veterinarians, and other
stakeholders.
Additional information on each of
these key areas is provided in the
whitepaper in the docket.
B. What feedback do EPA and FDA hope
to gain from the public meeting and
comments?
The virtual public meeting will focus
on the whitepaper and the following
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11436
Federal Register / Vol. 88, No. 36 / Thursday, February 23, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
questions. We are not seeking input or
comments about any specific products,
other federal agencies’ product
oversight, or other topics outside the
scope of the whitepaper and the
questions below. We are particularly
interested in receiving comments from
the public on the following:
1. What do you perceive as the
strengths and weaknesses of each
agency in regulating these types of
products?
2. Are there additional or different
challenges that EPA and FDA did not
identify in the whitepaper?
3. How can EPA and FDA
communicate with their stakeholders
about the regulation of these products in
a clearer and more transparent manner?
4. For regulated entities, how have
you historically determined which
agency to approach first to bring your
product to market?
5. For consumers, do you know who
is regulating the products you use on
your animal(s)? If you have a concern or
complaint about a specific product, do
you know which agency to contact?
6. How should EPA and FDA modify
product oversight to better align with
each agency’s mission and expertise?
7. What difficulties would you
envision if EPA and FDA were to
modify product oversight to better align
with each agency’s mission and
expertise, and how could they be
mitigated?
C. How are EPA and FDA seeking public
comments?
EPA and FDA are seeking public
comments through several planned
activities including:
• Through this Federal Register
document, EPA is announcing that it is
co-hosting a virtual public meeting with
FDA on the date identified in DATES to
seek input from stakeholders on the
agencies’ current approaches to the
oversight of various products regulated
as either pesticides by EPA or new
animal drugs by FDA. The agenda and
instructions for registration for this
meeting are available through a link on
the OPP website available at: https://
www.epa.gov/pesticides.
• EPA and FDA are announcing the
availability of and are soliciting
comment on the whitepaper and the
questions posed in Unit II.B.
• Following the public meeting and
the close of the comment period, EPA
and FDA will consider comments
received in determining next steps.
D. How can I access the documents?
The whitepaper is available in the
docket at https://www.regulations.gov;
identified as docket ID No. EPA–HQ–
VerDate Sep<11>2014
17:12 Feb 22, 2023
Jkt 259001
OPP–2023–0103. In addition, EPA and
FDA may include additional
background documents in the docket as
the materials become available.
III. Public Participation Instructions
To participate in the virtual public
meeting, please follow the instructions
in this unit.
A. How can I provide comments?
To ensure proper receipt of
comments, it is imperative that you
identify docket ID No. EPA–HQ–OPP–
2023–0103 in the subject line on the
first page of your comments.
1. Written comments. You are
encouraged to provide written
comments that are submitted using the
instructions in ADDRESSES and Unit I.B.
and C., on or before the date set in the
DATES section.
2. Oral comments. If you want to
make brief oral comments during the
virtual public meeting, please indicate
this interest during registration for the
virtual public meeting on or before
March 15, 2023. Please follow the
registration instructions available
through a link on the OPP website
available at: https://www.epa.gov/
pesticides.
After the agencies receive all
registrations for oral comments, they
will determine the amount of time to
allot to each commenter and email that
information to all commenters.
B. How can I participate in the virtual
public meeting?
This meeting is virtual and will occur
via webcast. For information on how to
register and then view the webcast,
please refer to the registration
instructions available through a link on
the OPP website available at: https://
www.epa.gov/pesticides.
Authority: 7 U.S.C. 136 et seq.
Dated: February 17, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemicals
Safety and Pollution Prevention.
[FR Doc. 2023–03739 Filed 2–22–23; 8:45 am]
BILLING CODE 6560–50–P
EPA has received applications
to register new uses for pesticide
products containing currently registered
active ingredients. Pursuant to the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is hereby
providing notice of receipt and
opportunity to comment on these
applications.
DATES: Comments must be received on
or before March 27, 2023.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2023–0067, and
the specific case number for the
chemical substance related to your
comment, 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. To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
FOR FURTHER INFORMATION CONTACT:
Anita Pease, Antimicrobials Division
(AD) (7510P), main telephone number:
(202) 566–0736: email address:
ADFRNotices@epa.gov; or Dan
Rosenblatt, Registration Division (RD)
(7505T), main telephone number: (202)
566–2875, email address:
RDFRNotices@epa.gov. The mailing
address for each contact person is Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001.
As part of the mailing address, include
the contact person’s name, division, and
mail code. The division to contact is
listed at the end of each application
summary.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2023–0067; FRL–10578–01–
OCSPP]
Pesticide Product Registration;
Receipt of Applications for New Uses
January 2023
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
E:\FR\FM\23FEN1.SGM
23FEN1
]]>Agencies
[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Notices]
[Pages 11434-11436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03739]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2023-0103; FRL-10689-01-OCSPP]
Modernizing the Approach to the Environmental Protection Agency
(EPA) and Food and Drug Administration (FDA) Oversight of Certain
Products; Notice of Public Meeting and Request for Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The U.S. Environmental Protection Agency (EPA)'s Office of
Chemical Safety and Pollution Prevention (OCSPP) is co-hosting a
virtual public meeting with the U.S. Food and Drug Administration
(FDA)'s Center of Veterinary Medicine (CVM) on March 22, 2023.
Additionally, EPA has opened a docket for the agencies to receive
public comment on their current approach to the oversight of various
products regulated as either pesticides by EPA or new animal drugs by
FDA, with a focus on parasite treatment products applied topically to
animals and in genetically engineered pest animals for use as pest
control tools. The agencies are also announcing the availability of and
soliciting comment on a document entitled, ``WHITEPAPER: A Modern
Approach to EPA and FDA Product Oversight'' that describes the current
challenges and
[[Page 11435]]
highlights the potential benefits of a modernized approach for
oversight of these products. EPA and FDA are considering how best to
update their respective oversight responsibilities for specific
products in an efficient and transparent manner and in alignment with
each agency's expertise, with the goal of improving protection of
human, animal, and environmental health. The purpose of the public
comment period and virtual public meeting is to obtain feedback from
stakeholders on the whitepaper and ideas for modernizing EPA and FDA's
approach to product oversight.
DATES:
Virtual Public Meeting: March 22, 2023, from 1:00 p.m. to 4:00 p.m.
(EDT). Registration to attend the virtual public meeting is required on
or before March 15, 2023. See the additional details and instructions
for registration that appear in Unit III.
Written Comments: Submit your comments on or before April 24, 2023.
As described in Unit III., you may also register to make oral comments
during the virtual public meeting.
Special accommodations: Requests for special accommodations should
be submitted as instructed under ADDRESSES on or before March 15, 2023,
to allow EPA and FDA time to process these requests.
ADDRESSES:
Virtual Public Meeting: You must register online to receive the
webcast meeting link and audio teleconference information on or before
the date set in the DATES section. Please follow the registration
instructions that is available through a link on the Office of
Pesticide Programs (OPP) website available at: https://www.epa.gov/pesticides. For additional instructions, see Unit III.
Written Comments: Submit written comments, identified by docket
identification (ID) No. EPA-HQ-OPP-2023-0103, through the Federal
eRulemaking Portal at https://www.regulations.gov. Follow the online
instructions for submitting comments. Do not electronically submit any
information you consider Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute. Additional
information on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
Special accommodations: For information on access or services for
individuals with disabilities, and to request accommodation for a
disability, please contact Paul Di Salvo, listed under FOR FURTHER
INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Paul Di Salvo, Office of Chemical
Safety and Pollution Prevention, Registration Division (7505T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 566-2597; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This notice is directed to the general public and may be of
specific interest to persons (e.g., industry, non-governmental
organizations (NGOs), animal owners, veterinarians, and academia) who
are or may be interested in regulation of parasite treatment products
applied topically to animals or in genetically engineered pest animals
for use as pest control tools. Because other entities may also be
interested in this notice, the agencies have not attempted to describe
all entities that may be interested in this subject.
B. Where can I access information about this meeting?
Information about this meeting is available through a link on the
OPP website available at: https://www.epa.gov/pesticides. Supporting
materials are available in the docket for this meeting, identified by
docket ID No. EPA-HQ-OPP-2023-0103, at https://www.regulations.gov.
C. What should I consider as I prepare my comments?
1. Submitting CBI. Do not submit CBI information through https://www.regulations.gov or email. If your comments contain any information
that you consider to be CBI or otherwise protected, please contact the
individual listed under FOR FURTHER INFORMATION CONTACT to obtain
special instructions before submitting your comments.
2. Tips for preparing your comments. When preparing and submitting
your comments, see Tips for Effective Comments at https://www.epa.gov/dockets.
II. Background
A. Why are EPA and FDA hosting this public meeting and soliciting
public comment?
Currently, EPA and FDA determine regulatory oversight of pesticides
and new animal drugs based on the rationale described in a Memorandum
of Understanding (MOU) between the agencies signed in 1971 and revised
in 1973. Since that time, pesticide and animal drug technologies--and
both agencies' understanding of these technologies--have evolved.
For example, parasite treatment products applied topically to
animals generally are regulated by EPA if they remain on the skin to
control only external parasites (e.g., fleas, ticks) and by FDA if they
are absorbed systemically into the bloodstream to control internal
parasites (e.g., intestinal worms). The agencies now understand that
many of the topically administered products currently regulated by EPA
do not remain on the skin and are actually absorbed into the
bloodstream, highlighting challenges with the current approach and
raising different safety concerns than originally anticipated.
Additionally, genetically engineered (``GE'') pest animals, which
are gaining interest as a pest control tool, were not envisioned 50
years ago when the original regulatory approach was developed. As
agreed in the 2016 National Strategy for Modernizing the Regulatory
System for Biotechnology Products, EPA and FDA have considered how to
update their respective responsibilities with the goal of developing an
efficient, transparent, and predictable approach for overseeing GE
insects. Recently, Executive Order 14081, issued September 12, 2022,
has further directed the agencies to improve the clarity and efficiency
of the regulatory process for biotechnology products, underscoring the
need for continued coordination between the agencies on biotechnology.
The agencies' current approach to determining whether EPA or FDA is
the appropriate regulator of certain products does not effectively
reflect or accommodate scientific advancement, and it has become clear
in some cases that the current approach has resulted in misalignment
between product characteristics and the agency better equipped to
regulate the product. A modernized approach would ensure that the
oversight of these products better aligns with each agency's expertise,
accounts for scientific advancement, avoids redundancy, better protects
animal health and safety, and improves regulatory clarity for regulated
entities, animal owners, veterinarians, and other stakeholders.
Additional information on each of these key areas is provided in
the whitepaper in the docket.
B. What feedback do EPA and FDA hope to gain from the public meeting
and comments?
The virtual public meeting will focus on the whitepaper and the
following
[[Page 11436]]
questions. We are not seeking input or comments about any specific
products, other federal agencies' product oversight, or other topics
outside the scope of the whitepaper and the questions below. We are
particularly interested in receiving comments from the public on the
following:
1. What do you perceive as the strengths and weaknesses of each
agency in regulating these types of products?
2. Are there additional or different challenges that EPA and FDA
did not identify in the whitepaper?
3. How can EPA and FDA communicate with their stakeholders about
the regulation of these products in a clearer and more transparent
manner?
4. For regulated entities, how have you historically determined
which agency to approach first to bring your product to market?
5. For consumers, do you know who is regulating the products you
use on your animal(s)? If you have a concern or complaint about a
specific product, do you know which agency to contact?
6. How should EPA and FDA modify product oversight to better align
with each agency's mission and expertise?
7. What difficulties would you envision if EPA and FDA were to
modify product oversight to better align with each agency's mission and
expertise, and how could they be mitigated?
C. How are EPA and FDA seeking public comments?
EPA and FDA are seeking public comments through several planned
activities including:
Through this Federal Register document, EPA is announcing
that it is co-hosting a virtual public meeting with FDA on the date
identified in DATES to seek input from stakeholders on the agencies'
current approaches to the oversight of various products regulated as
either pesticides by EPA or new animal drugs by FDA. The agenda and
instructions for registration for this meeting are available through a
link on the OPP website available at: https://www.epa.gov/pesticides.
EPA and FDA are announcing the availability of and are
soliciting comment on the whitepaper and the questions posed in Unit
II.B.
Following the public meeting and the close of the comment
period, EPA and FDA will consider comments received in determining next
steps.
D. How can I access the documents?
The whitepaper is available in the docket at https://www.regulations.gov; identified as docket ID No. EPA-HQ-OPP-2023-0103.
In addition, EPA and FDA may include additional background documents in
the docket as the materials become available.
III. Public Participation Instructions
To participate in the virtual public meeting, please follow the
instructions in this unit.
A. How can I provide comments?
To ensure proper receipt of comments, it is imperative that you
identify docket ID No. EPA-HQ-OPP-2023-0103 in the subject line on the
first page of your comments.
1. Written comments. You are encouraged to provide written comments
that are submitted using the instructions in ADDRESSES and Unit I.B.
and C., on or before the date set in the DATES section.
2. Oral comments. If you want to make brief oral comments during
the virtual public meeting, please indicate this interest during
registration for the virtual public meeting on or before March 15,
2023. Please follow the registration instructions available through a
link on the OPP website available at: https://www.epa.gov/pesticides.
After the agencies receive all registrations for oral comments,
they will determine the amount of time to allot to each commenter and
email that information to all commenters.
B. How can I participate in the virtual public meeting?
This meeting is virtual and will occur via webcast. For information
on how to register and then view the webcast, please refer to the
registration instructions available through a link on the OPP website
available at: https://www.epa.gov/pesticides.
Authority: 7 U.S.C. 136 et seq.
Dated: February 17, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemicals Safety and Pollution
Prevention.
[FR Doc. 2023-03739 Filed 2-22-23; 8:45 am]
BILLING CODE 6560-50-P
