[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 [www.gpo.gov]
[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 
https://www.regulations.gov 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 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: <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 
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, 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: 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.
    <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 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 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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