Rule2023-14404
Benzpyrimoxan; 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
July 10, 2023
Effective
July 10, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of benzpyrimoxan in or on rice, husked; rice, polished rice; and rice, bran. 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 130 (Monday, July 10, 2023)</title>
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[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Rules and Regulations]
[Pages 43442-43446]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14404]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0646; FRL-11057-01-OCSPP]
Benzpyrimoxan; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
benzpyrimoxan in or on rice, husked; rice, polished rice; and rice,
bran. Nichino America, Inc. requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 10, 2023. Objections and
requests for hearings must be received on or before September 8, 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-2021-0646, 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 the OPP docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, 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#fcaeb8baaeb29388959f998fbc998c9dd29b938a"><span class="__cf_email__" data-cfemail="97c5d3d1c5d9f8e3fef4f2e4d7f2e7f6b9f0f8e1">[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 Federal Register
Office'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-2021-0646 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
September 8, 2023. 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-2021-0646, 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/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 February 25, 2022 (87 FR 10760) (FRL-
9410-01-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 1E8949) 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
insecticide benzpyrimoxan, including its metabolites and degradates, in
or on the raw agricultural commodity rice, grain at 0.9 parts per
million (ppm). The requested tolerance is for food imported into the
U.S. and it is not registered for use in the U.S. 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>. One comment was received on the notice of filing.
EPA's response to the comment is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA is
revising the tolerance commodity definition for the requested tolerance
in/on rice, grain and is also establishing tolerances for rice,
polished rice and rice, bran. The reason for these changes is explained
in Unit IV.D.
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. . .
.''
[[Page 43443]]
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 benzpyrimoxan including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with benzpyrimoxan
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 toxicology database for benzpyrimoxan is complete for the
establishment of a tolerance without U.S. registration. The affected
target organs following the administration of benzpyrimoxan are the
kidney and urinary tract. Crystals were observed in the kidneys and
urinary tract along with tissue damage in both mice and rats following
subchronic and chronic oral administration. The rat appeared to be the
most sensitive species tested, with mouse and dog having similar
toxicity. There did not appear to be a difference in toxicity by sex in
any species.
Increased quantitative susceptibility was seen in the rabbit
preliminary developmental study where decreases in fetal body weight
were observed in the absence of adverse maternal toxicity. There was no
evidence of increased quantitative or qualitative lifestage
susceptibility in the definitive rat or rabbit developmental toxicity
or in the preliminary rat developmental toxicity. Increased qualitative
susceptibility in the form of mortality (post-implantation loss and
decreased viability index) was seen in the reproductive toxicity study
in rats. The concern for increased susceptibility is low as there were
clear lowest-observed-adverse-effect-levels (LOAELs) and no-observed-
adverse-effect-levels (NOAELs) in the developmental and reproductive
toxicity studies and the points of departure (PODs) are protective of
the increased susceptibility. There was no evidence of treatment-
related tumors in the rat or mouse carcinogenicity studies and all of
the mutagenicity studies were negative.
Benzpyrimoxan is classified as: ``Not likely to be carcinogenic to
humans'' based on lack of treatment-related tumors in long-term dietary
studies in the rat and mouse and low concern for genotoxicity. No
treatment-related increase in the incidence of tumors was observed in
carcinogenicity studies in rats or mice. Additionally, there is no
evidence of mutagenicity in vivo or in vitro.
Toxicity data were submitted for the benzpyrimoxan metabolite DH-04
in the form of a 90-day oral toxicity study in rats. In this study,
kidney effects and urine effects were observed in males and females at
65 and 78 mg/kg/day, respectively. Mortality was observed at the
highest dose tested (168/181 mg/kg/day [M/F]), and histopathological
evaluation revealed various cardiovascular and/or renal lesions. By
comparing the effects at the LOAEL for this study to the parent 90-day
oral rat study, it is estimated that DH-04 is approximately 3X more
toxic than the parent compound. Consequently, a 3X potency factor for
DH-04 will be used when conducting the dietary exposure assessment.
Specific information on the studies received and the nature of the
adverse effects caused by benzpyrimoxan 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 ``Benzpyrimoxan: First Food Use; Human
Health Risk Assessment to Support the Establishment of a Tolerance
without U.S. Registration in/on Rice'' hereinafter ``Benzpyrimoxan
Human Health Risk Assessment'' at page 24 in docket ID number EPA-HQ-
OPP-2021-0646.
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 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 benzpyrimoxan used for
human risk assessment can be found in the Benzpyrimoxan Human Health
Risk Assessment on pages 15-16.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to benzpyrimoxan, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
benzpyrimoxan 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. No such effects were
identified in the toxicological studies for benzpyrimoxan; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used 2005-2010 food consumption data from the U.S.
Department of Agriculture's National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in
food, EPA used tolerance-level residues (or higher to account for
additional residues of concern), default processing factors, and 100
percent crop treated (PCT) assumptions.
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.
Based on the data summarized in Unit III.A., EPA has concluded that
benzpyrimoxan does not pose a cancer risk to humans due to absence of
treatment-related tumors or evidence of mutagenicity in the available
studies. Therefore, a dietary exposure assessment for the purpose of
assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT
[[Page 43444]]
information in the dietary assessment for benzpyrimoxan. Tolerance
level residues (or higher to account for additional residues of
concern), default processing factors, and 100 PCT were assumed for all
food commodities.
2. Dietary exposure from drinking water. EPA assumes that there is
no exposure through drinking water because benzpyrimoxan is not
registered for use in the United States. Because residues are not
expected in drinking water, dietary risk estimates include exposures
from food only.
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). Benzpyrimoxan 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to benzpyrimoxan and any
other substances. In addition, benzpyrimoxan does not appear to produce
a toxic metabolite produced by other substances. For the purposes of
this action, therefore, EPA has not assumed that benzpyrimoxan has a
common mechanism of toxicity with other substances.
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 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. There was no evidence of
increased quantitative or qualitative lifestage susceptibility in the
definitive rat or rabbit developmental toxicity or in the preliminary
rat developmental toxicity. However, in the preliminary rabbit
developmental study, which tested up to a higher dose than the
definitive study (30 mg/kg/day), decreased fetal body weights were
observed at 60 mg/kg/day in the absence of adverse maternal effects.
Marginal body-weight decreases associated with marked food consumption
decreases were observed in the maternal animals in this study, but they
did not reach adversity.
In the two-generation reproduction study, the parental animals had
gross (depressed areas) and histopathological (pelvic crystals and
obstructive nephropathy) effects in the kidneys of P and F1 generation
males. Degenerative necrosis and hepatocyte centrilobular hypertrophy
associated with increased liver weights were also observed in the
parental generation. In the offspring F1 and F2 generations, increased
incidences of mortality and decreases in pup body weight were observed.
Increased incidence of post-implantation loss and decreased viability
indices early during lactation at the same dose as that eliciting
parental effects were considered to be both offspring and reproductive
effects and indicated increased qualitative susceptibility.
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 from 10X to 1X. That decision is based on the
following findings:
i. The toxicity database for benzpyrimoxan is complete for
evaluating and characterizing toxicity, assessing pre- and postnatal
susceptibility under FQPA, and selecting endpoints for the anticipated
exposure pathways. Developmental toxicity studies in the rat and rabbit
and a two-generation reproductive toxicity study in the rat are
available, in addition to an acute neurotoxicity study.
ii. There is no evidence of neurotoxicity in the benzpyrimoxan
database including an acute neurotoxicity study which tested up to the
limit dose and functional observation batteries and motor activity
observations performed in the 90-day and combined chronic/
carcinogenicity rat studies. EPA has waived both the subchronic
neurotoxicity and immunotoxicity studies at this time.
iii. As stated above, no evidence of increased quantitative or
qualitative lifestage susceptibility was seen in the definitive rat and
rabbit developmental studies, as there were no maternal or
developmental adverse effects in those studies. In the preliminary
rabbit developmental study, which tested up to a higher dose (60 mg/kg/
day) than the definitive study (30 mg/kg/day), adverse fetal body
weights were observed in the absence of adverse maternal effects,
suggesting quantitative susceptibility at >=60 mg/kg/day. Transient
body-weight decreases and marked decreases in food consumption during
treatment were observed in maternal animals at this dose but were not
considered to reach adversity; however, based on the findings at the
highest dose tested (60 mg/kg/day) it is unlikely that the maternal
animals could have tolerated much higher dosing given those
observations. In the two-generation reproduction toxicity study,
parental toxicity (kidney and liver effects) was observed at the same
dose as offspring (mortality, decreases in body weight, post-
implantation loss, and decreased viability indices) and reproductive
(post-implantation loss and decreased viability indices) effects. The
concern for susceptibility observed in the preliminary developmental
study in rabbits is low as the effects in the maternal animals
approached adversity. Additionally, there is a clear NOAEL established
for developmental effects in that study and the offspring and
reproductive effects in the two-generation reproduction study, and the
PODs selected for risk assessment are protective of the observed
quantitative and qualitative susceptibility in those two studies.
iv. There are no residual uncertainties identified in the exposure
databases. An unrefined dietary exposure assessment was completed
(tolerance level residues (or higher to account for additional residues
of concern), default processing factors, and 100 PCT were assumed). In
addition, there are no proposed or registered uses that would result to
residential exposures. These assessments will not underestimate the
exposure and risks posed by benzpyrimoxan.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing dietary exposure estimates to the acute
PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-
term
[[Page 43445]]
aggregate risks are evaluated by comparing the estimated total food,
water, and residential exposure to the appropriate PODs to ensure that
an adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
benzpyrimoxan is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
benzpyrimoxan from food only will utilize less than (<) 1% of the cPAD
for all infants (<1 year old), the subpopulation with the highest risk
estimate. There are no residential uses for benzpyrimoxan.
3. Short- and intermediate- term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Because benzpyrimoxan
is not registered in the United States, the only exposures will be
dietary from residues in or on imported rice; therefore, no short-term
or intermediate-term residential exposure is expected. Because there is
no short- 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 risk), no further assessment of short- or intermediate-term risk
is necessary, and EPA relies on the chronic dietary risk assessment for
evaluating short- and intermediate-term risk for benzpyrimoxan.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, benzpyrimoxan is not expected to pose a cancer risk to humans.
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 benzpyrimoxan residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (Smithers Method 14078.6140, a
QuEChERS based liquid chromatography with tandem mass spectrometry (LC-
MS/MS) multi-residue method) 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#99ebfceaf0fdecfcf4fcedf1f6fdead9fce9f8b7fef6ef"><span class="__cf_email__" data-cfemail="166473657f7263737b73627e7972655673667738717960">[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 benzpyrimoxan.
C. Response to Comments
One comment was received in response to the Notice of Filing. The
comment stated that ``there is still a lot we do not know about many of
the chemicals we utilize and ingestion of these chemicals is not likely
beneficial. Gathering that we should limit potential exposure to these
by consumers as much as possible, why was the petition made to grant an
exemption or tolerance? What is the user's or manufacturer's reasoning
to request the allowance of more of these chemicals to remain on
produce and potentially be ingested, and should more long-term
information be acquired on the chemicals before allowing such a
decision to be made?''
Although the Agency recognizes that some individuals believe
pesticides should be more restricted on agricultural crops, the
existing legal framework provided by section 408 of the FFDCA
authorizes EPA to establish tolerances when it determines that the
tolerance is safe. Upon consideration of the validity, completeness,
and reliability of the available data as well as other factors the
FFDCA requires EPA to consider, EPA has determined that benzpyrimoxan
tolerances are safe. The commenter has provided no information
indicating that a safety determination cannot be supported.
D. Revisions to Petitioned-For Tolerances
Although the petitioner requested a tolerance for ``rice, grain'',
EPA is establishing tolerances for ``rice, husked'', ``rice, polished
rice'', and ``rice, bran''. Each of these commodities is a processed
form of the ``rice, grain'' raw agricultural commodity that was
requested. Consistent with its authority to establish tolerances that
vary from what was requested under section 408(d)(4)(A)(i) of the
FFDCA, EPA is establishing tolerances that align better with the
Agency's current preferred commodity vocabulary and with the actual
form of the commodities that may be imported into the United States. In
addition, the available residue data indicate that separate tolerances
are needed for the processed commodities of ``rice, polished rice'' and
``rice, bran'' due to the concentration of residues.
V. Conclusion
Therefore, tolerances are established for residues of
benzpyrimoxan, including its metabolites and degradates, in or on rice,
husked at 0.9 ppm; rice, polished rice at 0.15 ppm; and rice, bran at 3
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 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
[[Page 43446]]
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 tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of 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: June 30, 2023.
Daniel Rosenblatt,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended 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. 180.724 to subpart C to read as follows:
Sec. 180.724 Benzpyrimoxan; tolerances for residues.
(a) General. Tolerances are established for residues of
benzpyrimoxan, including its metabolites and degradates, in or on the
commodities in Table 1 to this paragraph (a). Compliance with the
tolerance levels specified in Table 1 to this paragraph (a) is to be
determined by measuring residues of benzpyrimoxan (5-(1,3-dioxan-2-yl)-
4-[[4-(trifluoromethyl)phenyl]methoxy]pyrimidine) in or on the
following commodities:
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Rice, husked \1\........................................ 0.9
Rice, polished rice \1\................................. 0.15
Rice, bran \1\.......................................... 3
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of July 10, 2023.
(b)-(d) [Reserved]
[FR Doc. 2023-14404 Filed 7-7-23; 8:45 am]
BILLING CODE 6560-50-P
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