
[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Rules and Regulations]
[Pages 82782-82786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25871]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0198; FRL-11435-01-OCSPP]


Tolpyralate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
tolpyralate in or on barley, wheat and livestock commodities. ISK 
Biosciences Corporation requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 27, 2023. Objections and 
requests for hearings must be received on or before January 26, 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-2022-0198, 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 for 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: Francisco Llarena-Arias, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; 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 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).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     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 EPA's 
tolerance regulations at 40 CFR part 180 through the Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/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-2022-0198 in 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 
January 26, 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-2022-0198, 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/

[[Page 82783]]

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/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 20, 2022 (87 FR 30855) (FRL-9410-13-
OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1F8958) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, 
Concord, Ohio, 44077. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the herbicide 
tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-
(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate 
including its metabolite MT-2153, in or on barley, grain at 0.015 parts 
per million (ppm); barley, hay at 0.2 ppm; barley, straw at 0.08 ppm; 
wheat, grain at 0.01 ppm; wheat, forage at 0.02 ppm; wheat, hay at 0.05 
ppm; wheat, straw at 0.03 ppm. That document referenced a summary of 
the petition prepared by ISK Biosciences Corporation, the registrant, 
which is available in the docket, https://www.regulations.gov. There 
were no comments received in response to the notice of filing. Based 
upon review of the data supporting the petition, EPA is establishing 
tolerances for residues in livestock commodities. The reasons for these 
changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for tolpyralate including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with tolpyralate follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections of the rule that repeat what 
has been previously published in tolerance rulemakings for the same 
pesticide chemical. Where scientific information concerning a 
particular chemical remains unchanged, the content of those sections 
would not vary between tolerance rulemaking and republishing the same 
sections is unnecessary and duplicative. EPA considers referral back to 
those sections as sufficient to provide an explanation of the 
information EPA considered in making its safety determination for the 
new rulemaking.
    EPA has previously published a number of tolerance rulemakings for 
tolpyralate, in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to tolpyralate and established 
tolerances for residues of that chemical. EPA is incorporating 
previously published sections from those rulemakings as described 
further in this rulemaking, as they remain unchanged.

A. Toxicological Profile

    For a discussion of the Toxicological Profile of tolpyralate, see 
Unit III.A. of the July 27, 2017, rulemaking (82 FR 34877) (FRL-9964-
15).

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. The PODs and levels of concern have not changed from the 
previous rulemaking and EPA incorporates the background information in 
the July 27, 2017, rulemaking. In addition, a summary of the 
toxicological endpoints for tolpyralate used for human risk assessment 
can be found in the document titled Tolpyralate: Human Health Risk 
Assessment for the Proposed Uses on Wheat and Barley and Addition of 
Aerial Application for Corn. (hereinafter ``Tolpyralate Human Health 
Risk Assessment'') in docket ID number EPA-HQ-OPP-2022-0198 in 
regulations.gov.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tolpyralate, EPA considered exposure under the petitioned-
for tolerances as well as all existing tolpyralate tolerances in 40 CFR 
180.696. EPA assessed dietary exposures from tolpyralate in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for tolpyralate. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) under the Continuing Survey of 
Food Intake by Individuals (CSFII) and the Centers for Disease Control 
(CDC) under the National Health and Nutrition Examination Survey/What 
We Eat in America (NHANES/WEIA) 2005-2010. As to residue levels in 
food, EPA assumed tolerance level residues for all commodities and 100% 
crop treated.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) under the Continuing Survey of Food 
Intake by Individuals (CSFII) and the CDC under the National Health and 
Nutrition Examination Survey/What We Eat in America (NHANES/WEIA) 2005-
2010. As to residue levels in food, EPA assumed tolerance level 
residues for all commodities and 100% crop treated.
    iii. Cancer. The Agency has determined that quantification of risk 
using a non-linear approach (i.e., reference dose or RfD), for 
tolpyralate will adequately account for all chronic toxicity, including 
carcinogenicity, that could result from exposure to tolpyralate. As a 
result, the chronic dietary exposure assessment is protective for 
potential cancer risk, and a separate cancer exposure assessment was 
not conducted.

[[Page 82784]]

    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for tolpyralate. Tolerance level residues and/or 
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The estimates for drinking 
water exposure have not changed since the previous tolerance 
rulemaking; the additional uses do not impact the previous calculations 
for drinking water exposure estimates. For a discussion of the dietary 
exposure of drinking water of tolpyralate, see Unit III.C.2. of the 
July 27, 2017, rulemaking.
    3. From non-dietary exposure. There are no residential (non-
occupational) exposures associated with the new proposed uses and 
tolpyralate is not registered for any use patterns that would result in 
residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. The Agency is required to consider the cumulative risks of 
pesticides sharing a common mechanism of toxicity. The Agency has 
determined that the HPPD inhibitors, which include tolpyralate, share a 
common mechanism of toxicity as discussed in the HPPD Inhibiting 
Herbicides: State of the Science paper (K. Yozzo and M. Perron, 09/18/
2020, TXR No. 0058084, D439367). As explained in that document, the 
members of this group share the ability to bind to and inhibit the HPPD 
enzyme, resulting in elevated systemic tyrosine levels and common 
apical outcomes that are mediated by tyrosine, including ocular and 
developmental effects. In 2021, after establishing a common mechanism 
grouping for the HPPD inhibitors, the Agency conducted the P-
Hydroxyphenyl-Pyruvate Dioxygenase (HPPD) Inhibitors Cumulative Risk 
Assessment: Benzobicyclon, Bicyclopyrone, Isoxaflutole, Mesotrione, 
Pyrasulfotole, Tembotrione, Tolpyralate, and Topramezone (J. Godshall, 
06/30/2021, D462487) and concluded that cumulative exposures to HPPD 
inhibitors (based on proposed and registered pesticidal uses at the 
time the assessment was conducted) did not present risks of concern.
    An updated cumulative risk assessment (CRA) was not performed for 
the proposed new uses of tolpyralate on barley and wheat. The 
tolerances for tolpyralate being established in this rulemaking for 
barley, wheat and livestock commoditiest, do not impact the screening-
level CRA based on low recommended tolerance levels relative to other 
HPPD inhibitors in the Cumulative Assessment Group (CAG). Therefore, an 
updated CRA is not necessary for tolpyralate.

D. Safety Factor for Infants and Children

    EPA continues to conclude that there are reliable data to support 
the reduction of the Food Quality Protection Act (FQPA) safety factor 
from 10X to 1X. See Unit III.D of July 27, 2017, rulemaking (82 FR 
34877) (FRL-9964-15) for a discussion of the Agency's rationale for 
that determination.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute population adjusted dose (aPAD) and chronic PAD (cPAD). For 
linear cancer risks, EPA calculates the lifetime probability of 
acquiring cancer given the estimated aggregate exposure. Short-, 
intermediate-, and chronic-term risks are evaluated by comparing the 
estimated aggregate food, water, and residential exposure to the 
appropriate PODs to ensure that an adequate margin of exposure (MOE) 
exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to tolpyralate will occupy 1.0% of the aPAD for females 13 to 49 years 
old, the only population relevant for assessing acute exposure to 
tolpyralate.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
tolpyralate from food and water will utilize 2.7% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. There are no residential uses for tolpyralate.
    3. Short-term risk. A short-term adverse effect was identified; 
however, tolpyralate is not registered for any use patterns that would 
result in short-term residential exposure. Short-term risk is assessed 
based on short-term residential exposure plus chronic dietary exposure. 
Because there is no short-term residential exposure and chronic dietary 
exposure has already been assessed under the appropriately protective 
cPAD (which is at least as protective as the POD used to assess short-
term risk), no further assessment of short-term risk is necessary, and 
EPA relies on the chronic dietary risk assessment for evaluating short-
term risk for tolpyralate.
    4. Intermediate-term risk. An intermediate-term adverse effect was 
identified; however, tolpyralate is not registered for any use patterns 
that would result in intermediate-term residential exposure. 
Intermediate-term risk is assessed based on intermediate-term 
residential exposure plus chronic dietary exposure. Because there is no 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess intermediate-term 
risk), no further assessment of intermediate-term risk is necessary, 
and EPA relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for tolpyralate.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit III.A., the chronic dietary exposure assessment is 
protective for potential cancer risk. Therefore, EPA does not expect 
exposure to tolpyralate to pose aggregate cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to tolpyralate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (ISK Biosciences Method JSM0433) 
for plant commodities is a LC-MS/MS method that can be used to analyze 
for parent tolpyralate. It has been developed and independently 
validated and is adequate to enforce the established and proposed 
tolerances. For all matrices and analytes, the level of quantification 
(LOQ), defined as the lowest level of method validation (LLMV) or 
lowest spiking level where acceptable precision and accuracy data were 
obtained, was determined to be 0.01 ppm. The limit of detection (LOD) 
was 0.004 ppm.
    Adequate enforcement methodology (ISK Biosciences Method D96518) 
for livestock commodities is a LC-MS/MS method that can be used to 
analyze for parent tolpyralate and the metabolite MT-2153 concurrently. 
It has been developed and independently validated and is adequate to 
enforce the established and proposed tolerances. For all matrices and 
analytes, the level of quantification (LOQ), defined as the lowest 
level of method validation (LLMV) or lowest spiking level where 
acceptable precision and accuracy data were obtained, was determined to 
be 0.01 ppm. The limit of detection (LOD) was 0.003 ppm.

[[Page 82785]]

    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. 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 a MRL for tolpyralate.

C. Revisions to Petitioned-For Tolerances

    The tolerances being established for the proposed new uses of 
tolpyralate are based on values obtained using the OECD MRL calculator 
and submitted residue data. The tolerances being established are 
consistent with the values in the petition, with the exception of 
barley, grain, which is established at 0.01 ppm instead of 0.015 ppm to 
correct a typo that was published in the Federal Register of May 20, 
2022 (87 FR 30855) (FRL-9410-13-OCSPP). EPA is establishing tolerances 
for residues in livestock commodities due to an update in the dietary 
burden calculation.
    As part of the review of the petition, a revised Maximum Reasonable 
Dietary Burden (MRDB), including the potential contributions of barley 
and wheat were evaluated. As indicated in EPA's regulation, 40 CFR 
180.6, when finite pesticide chemical residues will be found in 
livestock commodities as a result of the use of a pesticide in or on 
animal feedstuffs, EPA will establish tolerances in livestock 
commodities to accommodate those residues. The additional uses of 
tolpyralate on barley and wheat will result in an increase in the MRDB 
for beef and dairy cattle and consequently necessitate increasing 
tolerances for tolpyralate residues in ruminant commodities. New 
tolerance levels in ruminant commodities were determined using the 
Langmuir model, and based on that analysis, EPA is establishing 
tolerances for residues in or on cattle, byproducts at 0.02 ppm; goat, 
byproducts at 0.02 ppm; horse, byproducts at 0.02 ppm and sheep, 
byproducts at 0.02 ppm.

V. Conclusion

    Therefore, tolerances for plant commodities are established for 
residues of tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-
(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate in 
or on barley, grain at 0.01 ppm; barley, hay at 0.2 ppm; barley, straw 
at 0.08 ppm wheat, grain at 0.01 ppm; wheat, forage at 0.02 ppm; wheat, 
hay at 0.05 ppm and; wheat, straw at 0.03 ppm. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-
(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate, in 
or on the commodity.
    In addition, tolerances for livestock commodities are established 
for residues of tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-
methyl-4-(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl 
carbonate and metabolite MT-2153 [1-ethyl-5-hydroxy-1H-pyrazol-4-yl-3-
(2-methoxyethoxy)-4-mesyl-2-methylphenyl ketone], in or on cattle, 
byproducts at 0.02 ppm; goat, byproducts at 0.02 ppm; horse, byproducts 
at 0.02 ppm and sheep, byproducts at 0.02 ppm. Compliance with the 
tolerance levels specified below is to be determined by measuring 
tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-
(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate and 
metabolite MT-2153 [1-ethyl-5-hydroxy-1H-pyrazol-4-yl-3-(2-
methoxyethoxy)-4-mesyl-2-methylphenyl ketone], in or on the commodity.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. 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 tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 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 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).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will

[[Page 82786]]

submit 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: November 16, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the 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.  180.696 by:
0
a. Designating the introductory text of paragraph (a) as paragraph 
(a)(1) and the table in newly designated paragraph (a)(1) as table 1 to 
paragraph (a)(1).
0
b. Adding, in alphabetical order, in newly designated table 1 to 
paragraph (a)(1), the entries ``Barley, grain''; ``Barley, hay''; 
``Barley, straw''; ``Wheat, forage''; ``Wheat, grain''; ``Wheat, hay''; 
and ``Wheat, straw''.
0
c. Add paragraph (a)(2).
    The additions read as follows:


Sec.  180.696   Tolpyralate; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.01
Barley, hay.................................................         0.2
Barley, straw...............................................        0.08
 
                                * * * * *
Wheat, forage...............................................        0.02
Wheat, grain................................................        0.01
Wheat, hay..................................................        0.05
Wheat, straw................................................        0.03
------------------------------------------------------------------------

    (2) Tolerances are established for residues of tolpyralate, 1-[[1-
ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-(methylsulfonyl)benzoyl]-1H-
pyrazol-5-yl]oxy]ethyl methyl carbonate and metabolite MT-2153 [1-
ethyl-5-hydroxy-1H-pyrazol-4-yl-3-(2-methoxyethoxy)-4-mesyl-2-
methylphenyl ketone], in or on the livestock commodities in table 2 to 
this paragraph (a)(2). Compliance with the tolerance levels specified 
in table 2 to this paragraph (a)(2) is to be determined by measuring 
tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-
(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate and 
metabolite MT-2153 [1-ethyl-5-hydroxy-1H-pyrazol-4-yl-3-(2-
methoxyethoxy)-4-mesyl-2-methylphenyl ketone], in or on the commodity.

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, byproducts..........................................        0.02
Goat, byproducts............................................        0.02
Horse, byproducts...........................................        0.02
Sheep, byproducts...........................................        0.02
------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-25871 Filed 11-24-23; 8:45 am]
BILLING CODE 6560-50-P


