BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP- 2024-0278; FRL-12055-01-OCSPP]
Polytetrafluoroethylene; Revocation of the Tolerance Exemption When Used as an Inert
Ingredient in Pesticide Products
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: The Environmental Protection Agency (EPA or Agency) is proposing to revoke
the tolerance exemption for residues of polytetrafluoroethylene (CAS No. 9002-84-0) under the
Federal Food, Drug, and Cosmetic Act (FFDCA) when used as an inert ingredient in pesticide
formulations. EPA is proposing to revoke this tolerance exemption because
polytetrafluoroethylene, which has been identified as a per- and polyfluoroalkyl substance
(PFAS), is no longer used in any registered pesticide product.
DATES: Comments must be received on or before [INSERT DATE 60 DAYS AFTER DATE
OF PUBLICATION IN THE FEDERAL REGISTER].
ADDRESSES: Submit your comments, identified by docket identification (ID) number EPAHQ-OPP-2024-0278, 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. Additional instructions on commenting and visiting the
docket, along with more information about dockets generally, is available at
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division
(7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; main telephone number: (202) 566-1030; email

address: RDFRNotices@epa.gov.
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), e.g., agricultural workers; greenhouse, nursery,
and floriculture workers; farmers.
• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle
farmers, livestock farmers.
• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse,
nursery, and floriculture workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial
applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR part 180 through the
Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to
any aspect of this regulation and may also request a hearing on those objections. You must file
your objection or request a hearing on this regulation in accordance with the instructions
provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2024-0278 the subject line on the first page of your submission. All

objections and requests for a hearing must be in writing and must be received by the Hearing
Clerk on or before [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE
FEDERAL REGISTER].
EPA’s Office of Administrative Law Judges (OALJ), where the Hearing Clerk is housed,
urges parties to file and serve documents by electronic means only, notwithstanding any other
particular requirements set forth in other procedural rules governing those proceedings. See
“Revised Order Urging Electronic Service and Filing”, dated June 22, 2023, which can be found
at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf. Although
EPA’s regulations require submission via U.S. Mail or hand delivery, EPA intends to treat
submissions filed via electronic means as properly filed submissions; therefore, EPA believes the
preference for submission via electronic means will not be prejudicial. When submitting
documents to the OALJ electronically, a person should utilize the OALJ e-filing system at
https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm.
In addition to filing an objection or hearing request with the Hearing Clerk as described
in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business
Information (CBI)) for inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the
non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQOPP-2024-0278, by one of the following methods:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the online
instructions for submitting comments. Do not submit electronically any information you consider
to be CBI or other information whose disclosure is restricted by statute.
• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC),
(28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed

information, please follow the instructions at https://www.epa.gov/dockets/where-sendcomments-epa-dockets.
Additional instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background
A. What action is the Agency taking?
EPA is proposing to revoke the tolerance exemption in 40 CFR 180.960 for
polytetrafluoroethylene (CAS No. 9002-84-0) when used as an inert ingredient in pesticide
formulations. This is being proposed because polytetrafluoroethylene has been identified as a
per- and polyfluoroalkyl substance (PFAS), and it is no longer used in any registered pesticide
product.
B. What is the Agency's authority for taking this action?
EPA is proposing this action pursuant to its authority under section 408 of the FFDCA,
21 U.S.C. 346a. Under section 408(e) of the FFDCA, EPA may issue a rule revoking tolerances
after providing notice of a proposed rulemaking and a period of not less than 60 days for public
comment. 21 U.S.C. 346a(e).
C. When does this action become effective?
EPA is proposing that this action become effective six months after the date of
publication of the final rule in the Federal Register. EPA is proposing this effective date for this
action to allow a reasonable interval for producers in exporting members of the World Trade
Organization's (WTO's) Sanitary and Phytosanitary (SPS) Measures Agreement to adapt to the
requirements of the final rule.
Any commodities treated with polytetrafluoroethylene in the channels of trade following
the tolerance exemption revocation shall be subject to FFDCA section 408(l)(5), 21 U.S.C.
346a(l)(5). Under this section, any residues of this pesticide in or on such food shall not render
the food adulterated so long as it is shown to the satisfaction of the Food and Drug

Administration that the residue is present as the result of an application or use of the pesticide at
a time and in a manner that was lawful under FIFRA and the residue does not exceed the level
that was authorized at the time of the application or use to be present on the food under a
tolerance or exemption, unless EPA determines that consumption of legally treated food during
the period of its likely availability in commerce will pose unreasonable dietary risk. Evidence to
show that food was lawfully treated may include records that verify the dates when the pesticide
was applied to such food.
III. Proposed Rule
EPA is proposing to revoke the tolerance exemption for use of polytetrafluoroethylene
(CAS No. 9002-84-0), also known as Teflon®, as an inert ingredient in pesticide products under
the 40 CFR 180.960. This action is being taken because polytetrafluoroethylene, which has been
identified as a per- and polyfluoroalkyl substance (PFAS), is no longer used in any registered
pesticide product.
PFAS are synthetic organic compounds that do not occur naturally in the environment but
have widespread use in commerce. The strong carbon-fluorine bonds of PFAS make some of
them resistant to degradation and thus highly persistent in the environment. Some PFAS have
been detected in wildlife and in humans, indicating that at least some PFAS have the ability to
bioaccumulate. All pesticide products registered in the United States that initially used
polytetrafluoroethylene as an inert ingredient have been cancelled or reformulated to no longer
contain polytetrafluoroethylene. Therefore, there are no current registrations for pesticide
products containing polytetrafluoroethylene as an inert ingredient.
After the close of the comment period, EPA will consider all comments received and
determine an appropriate final action.
IV. Statutory and Executive Order Reviews
In this proposed rule, EPA is proposing to revoke a specific tolerance exemption under its
authority in FFDCA section 408(e). The Office of Management and Budget (OMB) has

exempted this type of action ( e.g., tolerance exemption revocation for which extraordinary
circumstances do not exist) from review under Executive Order 12866, entitled “Regulatory
Planning and Review” (58 FR 51735, October 4, 1993) and updated by Executive Order 14094,
entitled “Modernizing Regulatory Review” (88 FR 21879, April 11, 2023). Because this
proposed rule has been exempted from review under Executive Order 12866, due to its lack of
significance, this proposed rule is not subject to Executive Order 13211, entitled “Actions
Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR
28355, May 22, 2001). This proposed rule does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.) or impose
any enforceable duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). Nor does it require any
special considerations as required under Executive Order 14096, entitled “Revitalizing our
Nation's Commitment to Environmental Justice for All” (88 FR 25251, April 26, 2023); or OMB
review or any other Agency action under Executive Order 13045, entitled “Protection of
Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997).
This proposed rule does not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency
previously assessed whether revocations of tolerances might significantly impact a substantial
number of small entities and concluded that, as a general matter, these actions do not impose a
significant economic impact on a substantial number of small entities. This analysis was
published in the Federal Register of December 17, 1997 (62 FR 66020) (FRL-5753-1) and was
provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into
account this analysis, and available information concerning the pesticide named in this proposed
rule, the Agency hereby certifies that this proposed rule will not have a significant negative

economic impact on a substantial number of small entities. In a memorandum dated May 25,
2001, EPA determined that eight conditions must all be satisfied in order for an import tolerance
or tolerance exemption revocation to adversely affect a significant number of small entity
importers, and that there is a negligible joint probability of all eight conditions holding
simultaneously with respect to any particular revocation. (This Agency document titled
“RFA/SBREFA Certification for Import Tolerance Revocation” is available in the docket of this
proposed rule.) Furthermore, for the pesticide named in this proposed rule, the Agency knows of
no extraordinary circumstances that exist as to the present proposed rule that would change
EPA's previous analysis. Any comments about the Agency's determination should be submitted
to the EPA along with comments on the proposed rule and will be addressed prior to issuing a
final rule.
In addition, the Agency has determined that this proposed rule will not have a substantial
direct effect on States, on the relationship between the National Government and the States, or
on the distribution of power and responsibilities among the various levels of government, as
specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).
Executive Order 13132, requires EPA to develop an accountable process to ensure “meaningful
and timely input by State and local officials in the development of regulatory policies that have
federalism implications.” “Policies that have federalism implications” is defined in the Executive
Order to include regulations that have “substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution of power and
responsibilities among the various levels of government.” This proposed rule directly regulates
growers, food processors, food handlers, and food retailers, not States. This proposed rule does
not alter the relationships or distribution of power and responsibilities established by Congress in
the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this proposed rule does not have any “tribal implications” as described in
Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal

Governments” (65 FR 67249, November 9, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure “meaningful and timely input by tribal officials in the
development of regulatory policies that have tribal implications.” “Policies that have tribal
implications” is defined in the Executive Order to include regulations that have “substantial
direct effects on one or more Indian tribes, on the relationship between the Federal Government
and the Indian tribes, or on the distribution of power and responsibilities between the Federal
Government and Indian tribes.” This proposed rule will not have substantial direct effects on
tribal governments, on the relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175, does not apply to this
proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural
commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: July 10, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution Prevention.

Therefore, for the reasons stated in the preamble, it is proposed that 40 CFR chapter I be
amended as follows:
PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL
RESIDUES IN FOOD
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Amend § 180.960, by removing the inert ingredient “polytetrafluoroethylene”
identified by CAS No. 9002-84-0 from Table 1 to § 180.960.
[FR Doc. 2024-15564 Filed: 7/15/2024 8:45 am; Publication Date: 7/16/2024]