Rule2023-18181
Pyraclonil; 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
August 24, 2023
Effective
August 24, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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).
Full Text
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<title>Federal Register, Volume 88 Issue 163 (Thursday, August 24, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<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 OPP Docket is (202) 566-1744. Please review the
visitor instructions and additional information about the docket
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division
(7505T), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (202) 566-1030; email address: <a href="/cdn-cgi/l/email-protection#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 <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-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 <a href="https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf">https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf</a>.
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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides</a>.
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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment</a>.
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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
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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