[Federal Register Volume 89, Number 136 (Tuesday, July 16, 2024)]
[Proposed Rules]
[Pages 57832-57834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15564]


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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.

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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 September 16, 2024.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-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: [email protected].

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

[[Page 57833]]

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 
September 16, 2024.
    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-HQ-OPP-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-send-comments-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[supreg], 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

[[Page 57834]]

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

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Amend Sec.  180.960, by removing the inert ingredient 
``polytetrafluoroethylene'' identified by CAS No. 9002-84-0 from Table 
1 to Sec.  180.960.

[FR Doc. 2024-15564 Filed 7-15-24; 8:45 am]
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