[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Rules and Regulations]
[Pages 57887-57891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18181]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0004; FRL-11246-01-OCSPP]


Pyraclonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyraclonil in or on rice, grain. Nichino America, Inc. requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 24, 2023. Objections and 
requests for hearings must be received on or before October 23, 2023 
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-2020-0004, 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 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#affdebe9fde1c0dbc6cccadcefcadfce81c8c0d9"><span class="__cf_email__" data-cfemail="93c1d7d5c1ddfce7faf0f6e0d3f6e3f2bdf4fce5">[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 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-2020-0004 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 
October 23, 2023. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b), although the 
Office of Administrative Law Judges encourages parties to file 
electronically. See https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
    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-2020-0004, 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

[[Page 57888]]

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. Summary of Petitioned-For Tolerance

    In the Federal Register of March 3, 2020 (85 FR 12454) (FRL-10005-
58), 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 
9F8809) by Nichino America, Inc., 4550 Linden Hill Road, Suite 501, 
Wilmington, DE 19808. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the herbicide 
pyraclonil, 1-(3-chloro-4,5,6,7-tetrahydropyrazolo[1,5-a]pyridin-2-yl)-
5-[methyl(prop-2-ynyl)amino]pyrazole-4-carbonitrile, in or on rice, 
grain at 0.01 parts per million (ppm). That document referenced a 
summary of the petition prepared by Nichino America, Inc., the 
registrant, which is available in the docket https://www.regulations.gov. Three comments supporting the registration were 
improperly filed in the docket for the notice of filing (NOF); there 
were no comments on the tolerance action.
    Based upon review of the data supporting the petition, EPA has 
recommended changes to the tolerance expression. The reason for these 
changes is 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 therein, 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 pyraclonil including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with pyraclonil follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The target organs of pyraclonil are the liver and the thyroid. 
Liver effects were found to be primarily adaptive (increased weight, 
hepatocellular hypertrophy, induction of cytochrome P450); however, 
female mice showed adverse liver effects (clinical chemistry changes, 
increased liver weight, and fat deposits after 90 days of oral 
exposure; these initial changes progressed to cellular alteration, 
liver masses, and hepatocellular adenomas after 78 weeks of oral 
exposure). Thyroid effects occurred in rats at similar doses across the 
database via oral exposures (lowest observed adverse effect levels 
(LOAELs) range from 74 to 207 mg/kg/day). Thyroid follicular cell 
hypertrophy was observed in both sexes of rats in several studies, 
after 14 or more days of oral exposure. Colloid degeneration was 
observed in both sexes, and thyroid follicular cell adenomas were 
observed in males in a chronic study. Increased blood levels of thyroid 
stimulating hormone (TSH) and decreased levels of thyroxine (T4) were 
detected after 1, 2, 52, and 104 weeks of oral exposure (hormones only 
measured in one 14-day oral study and one chronic study), in either or 
both sexes. No thyroid effects were detected in mice or dogs.
    No reproductive effects were detected. No increased pre- or 
postnatal susceptibility was detected. Pup weights were decreased in 
the rat reproductive study at the same dietary concentration at which 
thyroid effects were observed in adults. Decreased fetal weights were 
seen in a rat developmental study at the same dose as maternal clinical 
signs and decreased body weight. In an acute neurotoxicity study, 
decreased motor activity and several functional observation battery 
(FOB) findings (tremors, hunchback posture and slight lacrimation; 
decreased alertness, exploration, approach response and landing foot 
splay; and decreased body temperature) were noted only at 2 hours post-
dosing with a single dose of 400 mg/kg in females, and at higher doses 
in males. There was no effect of treatment on neurological parameters 
measured in a 90-day repeat dose studies in the rat.
    Pyraclonil is classified as ``Likely to be Carcinogenic to 
Humans'', based on treatment-related hepatocellular tumors in female 
mice (adenomas and combined adenomas/carcinomas), and thyroid 
follicular cell tumors in male rat (adenomas and combined adenomas/
carcinomas). The unit risk, Q1* (mg/kg/day)<SUP>-1</SUP> of pyraclonil 
based upon female mouse liver tumor rates is 1.08 x 10<SUP>-2</SUP> in 
human equivalents.
    Specific information on the studies received and the nature of the 
adverse effects caused by pyraclonil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document Pyraclonil. Human Health Risk 
Assessment for the New Active Ingredient for use on Rice at 11-14 in 
docket ID number EPA-HQ-OPP-2020-0004.

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. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin

[[Page 57889]]

of exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for pyraclonil used for 
human risk assessment can be found on pages 18-20 in the Pyraclonil 
Human Health Risk Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pyraclonil, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from pyraclonil 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 pyraclonil. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2005-2010 National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, EPA conducted an unrefined acute dietary exposure assessment for 
the proposed new use on rice and assumed 100 percent crop treated 
(PCT), tolerance-level residues and default processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2005-2010 
NHANES/WWEIA. As to residue levels in food, EPA conducted an unrefined 
chronic dietary exposure assessment for the proposed new use on rice 
and assumed 100 PCT, tolerance-level residues and default processing 
factors.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
If quantitative cancer risk assessment is appropriate, cancer risk may 
be quantified using a linear or nonlinear approach. If sufficient 
information on the carcinogenic mode of action is available, a 
threshold or nonlinear approach is used and a cancer RfD is calculated 
based on an earlier noncancer key event. If carcinogenic mode of action 
data are not available, or if the mode of action data determines a 
mutagenic mode of action, a default linear cancer slope factor approach 
is utilized. Based on the data summarized in Unit III.A., EPA has 
concluded that pyraclonil should be classified as ``Likely to be 
Carcinogenic to Humans'' and a linear approach has been used to 
quantify cancer risk. The inputs for the cancer dietary exposure 
assessment and the chronic dietary exposure assessment were equivalent 
with the exception of the estimated drinking water concentrations 
(EDWC) used. Applying the Q1* of 1.08 x 10<SUP>-2</SUP> (mg/kg/
day)<SUP>-1</SUP> to the exposure value (0.000136 mg/kg/day) results in 
a cancer risk estimate of 1 x 10<SUP>-6</SUP> for adults 20 to 49 years 
old.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for pyraclonil. Tolerance level residues and/or 
100PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for pyraclonil in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of pyraclonil. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.
    Based on the Pesticides in Flooded Application Model (PFAM version 
2.0), the maximum EDWCs of 50.8 [micro]g/L for the 1-in-10-year daily 
mean, 6.68 [micro]g/L for the 1-in-10-year annual mean, and 6.40 
[micro]g/L for the 30-year annual mean concentration in surface water 
were used in the acute, chronic, and cancer analyses, respectively.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Pyraclonil is not 
registered for any specific use patterns that would result in 
residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found pyraclonil to share a common mechanism of 
toxicity with any other substances, and pyraclonil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
pyraclonil does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act (FQPA) Safety Factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No increased pre- or 
postnatal susceptibility was detected in developmental studies in rats 
or rabbits, or in a reproductive study in rats.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for pyraclonil is complete.
    ii. Potential evidence of neurotoxicity was observed in the 
pyraclonil acute neurotoxicity study; however, concern is low since a 
clear NOAEL was established and the selected endpoints are protective 
of the observed effects.
    iii. There is no evidence that pyraclonil results in increased 
susceptibility in utero rats or rabbits in the prenatal developmental 
studies or in

[[Page 57890]]

young rats in the 2-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT, tolerance-level residues and default processing factors. 
EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to pyraclonil in 
drinking water. These assessments will not underestimate the exposure 
and risks posed by pyraclonil.

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 PAD (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 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 pyraclonil will occupy <1% of the aPAD for all infants <1 year old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
pyraclonil from food and water will utilize <1% of the cPAD for all 
infants <1 year old, the population group receiving the greatest 
exposure. There are no residential uses for pyraclonil.
    3. Short-term and Intermediate-term risk. Short-term and 
Intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    A short-term and intermediate-term adverse effect was identified; 
however, pyraclonil is not registered for any use patterns that would 
result in short-term or intermediate-term residential exposure. Short-
term or intermediate-term risk is assessed based on short-term or 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no short-term or 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 short-term and intermediate-term risk), no 
further assessment of short-term or intermediate-term risk is 
necessary, and EPA relies on the chronic dietary risk assessment for 
evaluating short-term and intermediate-term risk for pyraclonil.
    4. Aggregate cancer risk for U.S. population. The estimated 
exposure of adults 20 to 49 years old (the most highly exposed adult 
subpopulation) to pyraclonil is 0.000136 mg/kg/day. Applying the Q1* of 
1.08 x 10<SUP>-2</SUP> (mg/kg/day)<SUP>-1</SUP> to the exposure value 
results in a cancer risk estimate of 1 x 10<SUP>-6</SUP> for adults 20 
to 49 years old. EPA generally considers cancer risks (expressed as the 
probability of an increased cancer case) in the range of 1 in 1 million 
(or x 10<SUP>-6</SUP>) or less to be negligible. The precision which 
can be assumed for cancer risk estimates is best described by rounding 
to the nearest integral order of magnitude on the logarithmic scale; 
for example, risks falling between 3 x 10<SUP>-7</SUP> and 3 x 
10<SUP>-6</SUP> are expressed as risks in the range of 10<SUP>-6</SUP>. 
This is particularly the case where some conservatism is maintained in 
the exposure assessment. The pyraclonil exposure assessment is 
unrefined and retains significant conservatism in that tolerance-level 
residues and 100 percent crop treated is assumed for the rice use. In 
addition, EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to pyraclonil in 
drinking water. These assessments will not underestimate the exposure 
posed by pyraclonil. Accordingly, EPA has concluded the aggregate 
cancer risk for all existing pyraclonil uses and the new uses in this 
action fall within the range of 1 x 10<SUP>-6</SUP> and are thus 
negligible.
    5. 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 pyraclonil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology such as high-performance liquid 
chromatography method with tandem mass spectrometry detection (LC/MS/
MS), Method GLP-MTH-108, is available to enforce the tolerance 
expression.
    The method 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#b1c3d4c2d8d5c4d4dcd4c5d9ded5c2f1d4c1d09fd6dec7"><span class="__cf_email__" data-cfemail="e59780968c8190808880918d8a8196a5809584cb828a93">[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 pyraclonil.

C. Revisions to Petitioned-For Tolerances

    The Agency is establishing a tolerance for residues of pyraclonil 
expressed as: (1-(3-chloro-4,5,6,7-tetrahydropyrazolo[1,5-a]pyridin-2-
yl)-5-(methyl-2-propyn-1-ylamino)-1H-pyrazole-4-carbonitrile), which is 
the CAS name, rather than the petitioned for expression of pyraclonil: 
1-(3-chloro-4,5,6,7-tetrahydropyrazolo[1,5-a]pyridin-2-yl)-5-
[methyl(prop-2-ynyl)amino]pyrazole-4-carbonitrile, which is the IUPAC 
name.

V. Conclusion

    Therefore, tolerances are established for residues of pyraclonil, 
1-(3-chloro-4,5,6,7-tetrahydropyrazolo[1,5-a]pyridin-2-yl)-5-(methyl-2-
propyn-1-ylamino)-1H-pyrazole-4-carbonitrile, in or on rice, grain at 
0.01 ppm.

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

[[Page 57891]]

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 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: August 16, 2023.
Edward Messina,
Director, 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. Add Sec.  180.725 to subpart C to read as follows:


Sec.  180.725  Pyraclonil; tolerances for residues.

    (a)-(b) [Reserved]
    (c) Tolerances with regional registrations. Tolerances are 
established for residues of the herbicide pyraclonil, including its 
metabolites and degradates, in or on the commodities to the table to 
this paragraph (c). Compliance with the tolerance levels specified in 
the table to this paragraph (c) is to be determined by measuring only 
pyraclonil (1-(3-chloro-4,5,6,7-tetrahydropyrazolo[1,5-a]pyridin-2-yl)-
5-(methyl-2-propyn-1-ylamino)-1H-pyrazole-4-carbonitrile).

                        Table 1 to Paragraph (c)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Rice, grain...............................................         0.01
------------------------------------------------------------------------

    (d) [Reserved]

[FR Doc. 2023-18181 Filed 8-23-23; 8:45 am]
BILLING CODE 6560-50-P


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