Rule2023-25871
Tolpyralate; Pesticide Tolerances
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
November 27, 2023
Effective
November 27, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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).
Full Text
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<title>Federal Register, Volume 88 Issue 226 (Monday, November 27, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-25871]
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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.
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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
<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 for 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: 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:
<a href="/cdn-cgi/l/email-protection#4f1d0b091d01203b262c2a3c0f2a3f2e61282039"><span class="__cf_email__" data-cfemail="4d1f090b1f032239242e283e0d283d2c632a223b">[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 EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at <a href="https://www.ecfr.gov/title-40">https://www.ecfr.gov/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-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:
<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/
[[Page 82783]]
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/contacts.html">https://www.epa.gov/dockets/contacts.html</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. 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, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
<a href="http://regulations.gov">regulations.gov</a>.
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:
<a href="/cdn-cgi/l/email-protection#fe8c9b8d979a8b9b939b8a96919a8dbe9b8e9fd0999188"><span class="__cf_email__" data-cfemail="c1b3a4b2a8a5b4a4aca4b5a9aea5b281a4b1a0efa6aeb7">[email protected]</span></a>.
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
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