Rule2024-24814
Extension of Time-Limited Tolerances for Emergency Exemptions
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 25, 2024
Effective
October 25, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation extends time-limited tolerances for residues of the pesticides sodium salt of acifluorfen in or on Beet, sugar, roots and Beet, sugar, leaves; thiamethoxam in or on Rice, grain and Rice, straw; and clothianidin in or on Rice, grain. These actions are in response to EPA's granting of emergency exemptions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of these pesticides. In addition, the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA.
Full Text
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<title>Federal Register, Volume 89 Issue 207 (Friday, October 25, 2024)</title>
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[Federal Register Volume 89, Number 207 (Friday, October 25, 2024)]
[Rules and Regulations]
[Pages 85067-85069]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-24814]
[[Page 85067]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0413; FRL-12300-01-OCSPP]
Extension of Time-Limited Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation extends time-limited tolerances for residues
of the pesticides sodium salt of acifluorfen in or on Beet, sugar,
roots and Beet, sugar, leaves; thiamethoxam in or on Rice, grain and
Rice, straw; and clothianidin in or on Rice, grain. These actions are
in response to EPA's granting of emergency exemptions under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of
these pesticides. In addition, the Federal Food, Drug, and Cosmetic Act
(FFDCA) requires EPA to establish a time-limited tolerance or exemption
from the requirement for a tolerance for pesticide chemical residues in
food that will result from the use of a pesticide under an emergency
exemption granted by EPA.
DATES: This regulation is effective October 25, 2024. Objections and
requests for hearings must be received on or before December 24, 2024
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2024-0413, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is (202) 566-1744. Please review the
visitor instructions and additional information about the docket
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#2c7e686a7e624358454f495f6c495c4d024b435a"><span class="__cf_email__" data-cfemail="1c4e585a4e527368757f796f5c796c7d327b736a">[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 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).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
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, 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-2024-0413, in the subject line on the first
page of your submission. All requests must be in writing and must be
received by the Hearing Clerk on or before December 24, 2024. Addresses
for mail and hand delivery of objections and hearing requests are
provided in 40 CFR 178.25(b).
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-2024-0413, 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 and Statutory Findings
EPA previously published final rules in the Federal Register
establishing time-limited tolerances for the chemicals and commodities
listed below, under FFDCA section 408, 21 U.S.C. 346a. EPA established
the tolerances because FFDCA section 408(l)(6) requires EPA to
establish a time-limited tolerance or exemption from the requirement
for a tolerance for pesticide chemical residues in food that will
result from the use of a pesticide under an emergency exemption granted
by EPA under FIFRA section 18. Such tolerances can be established at
EPA's own initiative and without providing notice or time for public
comment.
EPA received requests to extend the emergency uses of the sodium
salt of acifluorfen and thiamethoxam for this year's growing season.
The use of thiamethoxam may also result in residues of its major
metabolite, clothianidin, which is measured and regulated separately.
The estimated potential residue level of clothianidin in or on rice
grain from the emergency exemption use of thiamethoxam is higher, at
0.5 ppm, than the tolerance established at 40 CFR 180.586(a) of 0.01
ppm in or on rice grain, associated with a different registered use
pattern. Therefore, a time-limited tolerance (associated with this
emergency exemption use of thiamethoxam) was previously established at
0.5 ppm in or on rice grain at 40 CFR 180.586(b). After having reviewed
these submissions, EPA concurs that emergency conditions continue to
exist. EPA assessed the potential risks presented by residues for each
chemical in or on the listed commodities. In doing so, EPA considered
the safety standard in FFDCA section 408(b)(2) and decided that the
necessary tolerance under FFDCA section 408(l)(6) would be consistent
with the safety standard and
[[Page 85068]]
with FIFRA section 18. The data and other relevant material have been
evaluated and were discussed in the final rules originally establishing
the time-limited tolerances. Based on the data and information
considered, the Agency affirms that extension of these time-limited
tolerances will continue to meet the requirements of FFDCA section
408(l)(6). Therefore, the time-limited tolerances are extended until
December 31, 2027. Although these tolerances will expire and are
revoked on December 31, 2027, under FFDCA section 408(l)(5), residues
of the pesticides not in excess of the amounts specified in the
tolerances remaining in or on the commodities after that date will not
be unlawful, provided the residues are present as a result of an
application or use of a pesticide at a time and in a manner that was
lawful under FIFRA, the tolerance was in place at the time of the
application, and the residues do not exceed the level that was
authorized by the tolerance. EPA will take action to revoke the
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Time-limited tolerances for the use of the following pesticide
chemicals on specific commodities are being extended:
Sodium salt of acifluorfen. Pursuant to requests by the Michigan,
Minnesota, and North Dakota Departments of Agriculture, EPA has
authorized under FIFRA section 18 the use of the sodium salt of
acifluorfen on sugar beets for control of glyphosate-resistant pigweed
species, Palmer amaranth and waterhemp, in their respective States.
This regulation extends the time-limited tolerances for residues of the
herbicide sodium salt of acifluorfen, including its metabolites and
degradates, in or on Beet, sugar, roots at 0.1 parts per million (ppm),
and Beet, sugar, leaves at 0.1 ppm, for an additional 3-year period.
The tolerances will expire and are revoked on December 31, 2027. The
time-limited tolerances were originally published in the Federal
Register of March 31, 2022 (87 FR 18717) (FRL-9657-01-OCSPP).
Thiamethoxam. Pursuant to a request from the Texas Department of
Agriculture, EPA has authorized under FIFRA section 18 the use of
thiamethoxam on rice for control of the rice delphacid in Texas. This
regulation extends the time-limited tolerances for residues of
thiamethoxam, including its metabolites and degradates, in or on Rice,
grain at 6 ppm, and Rice, straw at 2 ppm, for an additional 3-year
period. The tolerances will expire and are revoked on December 31,
2027. The time-limited tolerances were originally published in the
Federal Register of October 7, 2019 (84 FR 53326) (FRL-9996-14).
Clothianidin. Pursuant to a request from the Texas Department of
Agriculture, EPA has authorized under FIFRA section 18 the use of
thiamethoxam on rice for control of the rice delphacid in Texas.
Residues of clothianidin, a major metabolite of thiamethoxam, could
occur in rice grain as a result of this use, and a separate time-
limited tolerance was established. This regulation extends the time-
limited tolerance for residues of clothianidin in or on Rice, grain at
0.5 ppm for an additional 3-year period. The tolerance will expire and
is revoked on December 31, 2027. The time-limited tolerance was
originally published in the Federal Register of October 7, 2019 (84 FR
53331) (FRL-9996-15).
III. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established MRLs for sodium salt of acifluorfen.
The Codex established MRLs for thiamethoxam on rice commodities on
February 6, 2023. Since these were not in place when EPA established
the subject time-limited tolerances, there were no issues with
harmonization at that time (October 7, 2019). However, the Codex and
EPA residue definitions for thiamethoxam are different. EPA's
definition is for thiamethoxam plus its metabolite (CGA-322704), while
the Codex definition is for thiamethoxam only. Additionally, the Codex
MRLs are based upon a different use pattern than that for the emergency
exemption use in the U.S. Therefore, because of these differences, it
is not possible to harmonize the time-limited tolerances for
thiamethoxam with the Codex MRLs. Since EPA has determined these time-
limited tolerances are safe, EPA is extending the expiration dates for
these time-limited tolerances despite the lack of harmonization with
the related Codex MRLs.
For clothianidin, the time-limited tolerance of 0.5 ppm in or on
Rice, grain is consistent and harmonized with the existing Codex MRL of
0.5 ppm.
IV. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(e) at
EPA's own initiative to support use authorized under emergency
exemptions. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4,
1993). Because this action has been exempted from review under
Executive Order 12866, this action 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), or Executive Order 13045, entitled ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since time-limited tolerances and exemptions that are established
under FFDCA section 408(e) at EPA's own initiative to support use
authorized under emergency exemptions, such as the tolerances in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the National Government
and the States or Tribal governments, or on the distribution of
[[Page 85069]]
power and responsibilities among the various levels of government or
between the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not 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.).
This action 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).
V. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA has submitted a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 21, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for reasons stated in the preamble, EPA is amending 40
CFR chapter I 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. 180.383, in paragraph (b), by revising table 2 to read
as follows:
Sec. 180.83 Sodium salt of acifluorfen; tolerances for residues.
* * * * *
(b) * * *
Table 2 to Paragraph (b)
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Beet, sugar, roots...................... 0.1 12/31/2027
Beet, sugar, leaves..................... 0.1 12/31/2027
------------------------------------------------------------------------
* * * * *
0
3. Amend Sec. 180.565, in paragraph (b), by revising the table to read
as follows:
Sec. 180.565 Thiamethoxam; tolerances for residues.
* * * * *
(b) * * *
Table 2 to Paragraph (b)
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Rice, grain............................. 6 12/31/2027
Rice, straw............................. 2 12/31/2027
------------------------------------------------------------------------
* * * * *
0
4. Amend Sec. 180.586, in table 3 to paragraph (b), by revising the
entry for ``Rice, grain'' to read as follows:
Sec. 180.586 Clothianidin; tolerances for residues.
* * * * *
(b) * * *
Table 3 to Paragraph (b)
------------------------------------------------------------------------
Parts per
Commodity million Expiration date
------------------------------------------------------------------------
* * * * * * *
Rice, grain........................... 0.5 12/31/2027
------------------------------------------------------------------------
* * * * *
[FR Doc. 2024-24814 Filed 10-24-24; 8:45 am]
BILLING CODE 6560-50-P
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