Notice2023-03739
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
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Published
February 23, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 36 (Thursday, February 23, 2023)</title>
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[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Notices]
[Pages 11434-11436]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03739]
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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.
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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: <a href="https://www.epa.gov/pesticides">https://www.epa.gov/pesticides</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#f2969b81939e849ddc8293879eb2978293dc959d84"><span class="__cf_email__" data-cfemail="ed89849e8c819b82c39d8c9881ad889d8cc38a829b">[email protected]</span></a>.
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: <a href="https://www.epa.gov/pesticides">https://www.epa.gov/pesticides</a>. Supporting
materials are available in the docket for this meeting, identified by
docket ID No. EPA-HQ-OPP-2023-0103, at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
C. What should I consider as I prepare my comments?
1. Submitting CBI. Do not submit CBI information through <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<bullet> 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: <a href="https://www.epa.gov/pesticides">https://www.epa.gov/pesticides</a>.
<bullet> EPA and FDA are announcing the availability of and are
soliciting comment on the whitepaper and the questions posed in Unit
II.B.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>; 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: <a href="https://www.epa.gov/pesticides">https://www.epa.gov/pesticides</a>.
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: <a href="https://www.epa.gov/pesticides">https://www.epa.gov/pesticides</a>.
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
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