Proposed Rule2024-15564
Polytetrafluoroethylene; Revocation of the Tolerance Exemption When Used as an Inert Ingredient in Pesticide Products
Primary source
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Published
July 16, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 136 (Tuesday, July 16, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#30627476627e5f4459535543705540511e575f46"><span class="__cf_email__" data-cfemail="184a5c5e4a56776c717b7d6b587d6879367f776e">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
<bullet> Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
<bullet> Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
<bullet> 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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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 <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</a>.
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 <a href="https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions 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>.
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]
BILLING CODE 6560-50-P
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