[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]


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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: 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

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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]
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