Cloquintocet-mexyl in Pesticide Formulations; Tolerances for Residues, 18549-18553 [2024-05434]
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Federal Register / Vol. 89, No. 51 / Thursday, March 14, 2024 / Rules and Regulations
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List of Subjects in 40 CFR Part 52
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Authority: 42 U.S.C. 7401 et seq.
Dated: March 6, 2024.
Martha Guzman Aceves,
Regional Administrator, Region IX.
For the reasons stated in the
preamble, the Environmental Protection
Agency amends part 52, chapter I, title
40 of the Code of Federal Regulations as
follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart F—California
2. Section 52.220 is amended by
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reserved paragraph (c)(603)(ii)(C) to read
as follows:
■
§ 52.220
Identification of plan—in part.
*
*
*
*
*
(c) * * *
(603) * * *
(ii) * * *
(B) Sacramento Metropolitan Air
Quality Management District.
(1) ‘‘Second 10-Year PM10
Maintenance Plan for Sacramento
County,’’ adopted on September 23,
2021.
(2) [Reserved]
(C) [Reserved]
*
*
*
*
*
[FR Doc. 2024–05260 Filed 3–13–24; 8:45 am]
BILLING CODE 6560–50–P
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18549
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2022–0850; FRL–11811–01–
OCSPP]
Cloquintocet-mexyl in Pesticide
Formulations; Tolerances for Residues
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation amends the
tolerance expression for residues of the
safener cloquintocet-mexyl (acetic acid,
[(5-chloro-8-quinolinyl)oxy]-, 1methylhexyl ester) (CAS Reg. No.
99607–70–2) and its acid metabolite (5chloro-8-quinlinoxyacetic acid) by
removing the active ingredients listed in
the tolerance expression so that the
safener can be used in any herbicide
formulation applied to the listed
commodities. Corteva Agriscience
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting the revision to the
tolerance expression for residues of the
safener cloquintocet-mexyl. There is no
change to the numerical tolerances or
the listed commodities.
DATES: This regulation is effective
March 14, 2024. Objections and requests
for hearings must be received on or
before May 13, 2024 and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2022–0850, 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 the OPP
docket is (202) 566–1744. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
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: RDFRNotices@epa.gov.
ADDRESSES:
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SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Federal Register Office’s eCFR site at https://www.ecfr.gov/
current/title-40/chapter-I/subchapter-E/
part-180?toc=1.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2022–0850 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 May 13, 2024. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2022–0850, by one of the following
methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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online instructions for submitting
comments. Do not submit electronically
any information you consider to be CBI
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/where-sendcomments-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 December
19, 2023 (88 FR 87733, FRL–10579–11–
OSCPP), EPA issued a document
pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a
pesticide petition (PP IN–11655) by
Corteva Agriscience, 9330 Zionsville
Road, Indianapolis, IN 46268. The
petition requested that the tolerance
expression under 40 CFR 180.560 for
the safener cloquintocet-mexyl (acetic
acid, [(5-chloro-8-quinolinyl)oxy]-, 1methylhexyl ester) (CAS Reg. No.
99607–70–2) and its acid metabolite (5chloro-8-quinlinoxyacetic acid), be
amended to remove the active
ingredients listed. There was no
proposed change to the numerical
tolerances or the listed commodities.
This change would permit the use of the
safener, cloquintocet-mexyl, in any
herbicide formulation applied to the
listed commodities in accordance with
the established numerical tolerances.
That document referenced a summary of
the petition prepared by Corteva
Agriscience, which is available in the
docket at https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
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
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residential settings but does not include
occupational exposure. When making a
safety determination for a tolerance,
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. . . .’’
Section 408(b)(2)(D) lists other factors
for EPA’s consideration in making safety
determinations, including, for example,
the validity, completeness, and
reliability of available data, nature of
toxic effects, available information
concerning the cumulative effects of the
pesticide chemical and other substances
with a common mechanism of toxicity,
and available information concerning
aggregate exposure levels to the
pesticide chemical and other related
substances.
EPA establishes tolerances only in
those cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
foreseeable circumstances will pose no
harm to human health. In order to
determine the risks from aggregate
exposure to pesticide inert ingredients,
the Agency considers the toxicity of the
inert in conjunction with possible
exposure to residues of the inert
ingredient through food, drinking water,
and through other exposures that occur
as a result of pesticide use in residential
settings. If EPA is able to determine that
a finite tolerance is not necessary to
ensure that there is a reasonable
certainty that no harm will result from
aggregate exposure to the inert
ingredient, an exemption from the
requirement of a tolerance may be
established.
Consistent with FFDCA section
408(b)(2)(A), and the factors specified in
FFDCA section 408(b)(2)(C) and (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 cloquintocetmexyl, including exposure resulting
from the tolerances established by this
action. EPA’s assessment of exposures
and risks associated with cloquintocetmexyl follows.
In an effort to streamline its
publications in the Federal Register,
EPA is not reprinting sections that
repeat what has been previously
published for tolerance rulemakings for
the same chemical. Where scientific
information concerning a particular
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chemical remains unchanged, the
content of those sections would not vary
between tolerance rulemakings, and
EPA considers referral back to those
sections as sufficient to provide an
explanation of the information EPA
considered in making its safety
determination for the new rulemaking.
EPA has previously published
tolerance rulemakings for cloquintocetmexyl in which EPA concluded, based
on the available information, that there
is a reasonable certainty that no harm
would result from aggregate exposure to
cloquintocet-mexyl and established
tolerances for residues of that chemical.
EPA is incorporating previously
published sections from these
rulemakings as described further in this
rulemaking, as they remain unchanged.
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A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
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. For a discussion of
the toxicological profile of cloquintocetmexyl, please see Unit III.A. of the final
rule published in the Federal Register
of December 16, 2005 (70 FR 74679)
(FRL–7753–4), in which the Agency
presented the available toxicity data for
cloquintocet-mexyl. There have been no
changes to that toxicity data, and a
summary is presented below.
The toxicity database is sufficient for
cloquintocet-mexyl. Cloquintocet-mexyl
exhibits low levels of acute toxicity via
the oral, dermal, and inhalation routes
of exposure. It is not a skin irritant but
is a skin sensitizer. It is slightly
irritating to the eyes.
Although fetal effects were seen in a
reproductive and developmental study,
they were seen at maternally toxic
doses; therefore, there is no concern for
offspring susceptibility. Available
studies show no evidence of
neurotoxicity. Cloquintocet-mexyl is not
genotoxic and is classified as ‘‘not likely
to be a human carcinogen.’’
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
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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 https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/overview-riskassessment-pesticide-program.
The hazard profile of cloquintocetmexyl is adequately defined. An acute
reference dose (RfD) was selected for the
subpopulation of females 13–50 years
old of 1 mg/kg/day (NOAEL of 100 mg/
kg/day) from a developmental toxicity
in rats (MRID 44387429) where an
increased incidence of skeletal variants
and decreased fetal body weight was
observed in the presence of maternal
toxicity at 400 mg/kg/day. An acute RfD
for the general population was not
identified.
The Agency selected a chronic RfD of
0.04 mg/kg/day based on a two-year
combined chronic/oncogenicity study in
rats (MRID 44387431). In this study, the
NOAEL of 4.3 mg/kg/day was based on
increased incidence of thyroid follicular
epithelial hyperplasia in females at 41.2
mg/kg/day (LOAEL).
C. Exposure Assessment
To determine if removal of the active
ingredients from the tolerance
expression would affect residue levels
of cloquintocet-mexyl, EPA relied on
various residue trials on wheat and
barley conducted with 5 different
herbicides. EPA found, based on
consistent results from these studies,
that regardless of the chemical or class
of chemistry, the residue profile does
not change for cloquintocet-mexyl.
These residues consistently remained
below the currently established
tolerances for those commodities.
Based on a review of the data, there
is no expected increase in residue levels
associated with removing the active
ingredients from the tolerance
expression. Since no change is being
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18551
made to the numerical tolerances or the
listed commodities, there is no expected
change in dietary exposure.
1. Dietary exposure from food and
feed uses. Dietary exposure has already
been assessed based on the conservative
assumption that all three commodities
for which there are currently established
tolerances (i.e., wheat, barley, and teff)
are treated with cloquintocet-mexyl at
tolerance-level residues. These residue
levels have been found by the Agency
to be safe. For a discussion of the
dietary exposure to cloquintocet-mexyl,
please see Unit III.C. of the final rule
published in the Federal Register of
August 2, 2016 (81 FR 50630) (FRL–
9947–78), Unit III. of the final rule
published in the Federal Register of
March 22, 2017 (82 FR 14620) (FRL–
9959–11), and Unit III. of the final rule
published in the Federal Register of
September 11, 2018 (83 FR 45841)
(FRL–9980–90).
2. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables). There are currently no registered
uses for products containing
cloquintocet-mexyl that would result in
residential exposures.
3. 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 cloquintocetmexyl to share a common mechanism of
toxicity with any other substances, and
cloquintocet-mexyl does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this final rule, therefore, EPA has
assumed that cloquintocet-mexyl 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-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
D. Additional Safety Factor for the
Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA
provides that EPA shall apply an
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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. 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.
EPA has concluded that the FQPA
safety factor can be removed for
cloquintocet-mexyl for the following
reasons. The toxicology database is
complete for cloquintocet-mexyl. There
is no indication of quantitative or
qualitative increased susceptibility of
rats or rabbits to in utero and/or
postnatal exposure to cloquintocetmexyl in the available toxicity data, and
EPA has determined that a
developmental neurotoxicity study is
not required for cloquintocet-mexyl.
The dietary (food and drinking water)
exposure assessments will not
underestimate the potential exposures
for infants and children from the use of
cloquintocet-mexyl. Currently there are
no proposed residential uses, and
therefore non-occupational exposure is
not expected.
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
cloquintocet-mexyl will occupy less
than one percent (<1%) of the aPAD for
females aged 13–49, 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 cloquintocetmexyl from food and water will utilize
<1% of the cPAD for all subpopulations.
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There are no residential uses for
cloquintocet-mexyl.
3. Short- and intermediate-term risk.
Because cloquintocet-mexyl is not
registered for use in pesticide
formulations that will result in
residential exposure, EPA concludes
that cloquintocet-mexyl will not pose a
short-term or intermediate-term risk.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity,
cloquintocet-mexyl is not expected to
pose a cancer risk to humans.
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 cloquintocetmexyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology,
chromatography with ultraviolet
detection (HPLC–UV) for cloquintocetmexyl and its acid metabolite, 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:
residuemethods@epa.gov.
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).
Codex is a joint United Nations Food
and Agriculture Organization/World
Health Organization food standards
program, and it is recognized as an
international food safety standardssetting 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 cloquintocet-mexyl (acetic acid, [(5chloro-8-quiniolinyl)oxy]-, 1methylhexyl ester) or its acid
metabolite.
V. Conclusion
Therefore, EPA is removing the active
ingredients: clodinafop-propargyl
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(wheat only), dicamba (wheat only),
flucarbazone-sodium (wheat only),
halauxifen-methyl (wheat or barley),
pinoxaden (wheat or barley),
pyroxsulam (wheat or teff), florasulam
(teff), or fluroxypyr 1-methylheptyl ester
(teff) listed in the tolerance expression
for cloquintocet-mexyl.
VI. Statutory and Executive Order
Reviews
This action amends a tolerance under
FFDCA section 408(d) in response to a
petition submitted to the Agency. The
Office of Management and Budget
(OMB) has exempted these types of
actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
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Federal Register / Vol. 89, No. 51 / Thursday, March 14, 2024 / Rules and Regulations
‘‘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).
VIII. 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: March 11, 2024.
Charles Smith,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, for the reasons stated in the
preamble, the EPA amends 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.560:
a. Revise paragraph (a) introductory
text; and
■ b. Add the table heading ‘‘Table 1 to
Paragraph (a)’’.
The revision and addition reads as
follows:
ddrumheller on DSK120RN23PROD with RULES1
■
■
§ 180.560 Cloquintocet-mexyl; tolerances
for residues.
(a) General. Tolerances are
established for residues of the inert
ingredient cloquintocet-mexyl,
including its metabolites and
degradates, in or on the commodities in
VerDate Sep<11>2014
15:56 Mar 13, 2024
Jkt 262001
the following table when used as a
safener in herbicide formulations.
Compliance with the tolerance levels
specified is to be determined by
measuring the combined residues of
cloquintocet-mexyl, (acetic acid [(5chloro-8-quinolinyl)oxy]-, 1methylhexyl ester; CAS Reg. No. 99607–
70–2) and its acid metabolite (5-chloro8-quinolinoxyacetic acid), expressed as
cloquintocet-mexyl, in or on the
following commodities:
Table 1 to Paragraph (a)
*
*
*
*
*
[FR Doc. 2024–05434 Filed 3–13–24; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[MB Docket No. 24–4; RM–11974; DA 24–
212; FR ID 207908]
Television Broadcasting Services
Waynesboro, Virginia
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
On January 11, 2024, the
Video Division, Media Bureau (Bureau)
issued a Notice of Proposed Rulemaking
(NPRM) in response to a petition for
rulemaking VPM Media Corporation
(Petitioner), requesting the allotment of
reserved noncommercial educational
(NCE) television channel * 12 to
Waynesboro, Virginia (Waynesboro), in
the Table of TV Allotments as the
community’s first local television
service and its first NCE television
service. For the reasons set forth in the
Report and Order referenced below, the
Bureau amends FCC regulations by
allotting channel * 12 at Waynesboro.
DATES: Effective April 15, 2024.
FOR FURTHER INFORMATION CONTACT:
Emily Harrison, Media Bureau, at (202)
418–1665 or Emily.Harrison@fcc.gov.
SUPPLEMENTARY INFORMATION: The
proposed rule was published at 89 FR
3624 on January 19, 2024. The
Petitioner filed comments in support of
the petition reaffirming its commitment
to apply for channel * 12. No other
comments were filed.
The Bureau believes the public
interest would be served by allotting
channel * 12 at Waynesboro, which, as
of the 2020 Census, has a population of
22,196 and clearly qualifies for
community of license status for
SUMMARY:
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
18553
allotment purposes. Waynesboro has its
own ZIP Code, two post offices, city
council, public school system, police
department, and library. The proposal
would also result in a first local service
to Waynesboro under the Commission’s
second allotment priority. The
Petitioner demonstrates, and a staff
engineering analysis confirms, that
channel * 12 can be allotted to
Waynesboro consistent with the
minimum geographic spacing
requirements for new DTV allotments in
section 73.622(k) of the rules, at
37°38′24″ N and 78°27′11″ W (allotment
point). In addition, the allotment point
complies with section 73.618 of the
rules as the entire community of
Waynesboro is encompassed by the 43
dBm contour.
This is a synopsis of the
Commission’s Report and Order, MB
Docket No. 24–4; RM–11974; DA 24–
212, adopted March 7, 2024, and
released March 7, 2024. The full text of
this document is available for download
at https://www.fcc.gov/edocs. To request
materials in accessible formats for
people with disabilities (braille, large
print, electronic files, audio format),
send an email to fcc504@fcc.gov or call
the Consumer & Governmental Affairs
Bureau at 202–418–0530 (voice), 202–
418–0432 (tty).
This document does not contain
information collection requirements
subject to the Paperwork Reduction Act
of 1995, Public Law 104–13. In addition,
therefore, it does not contain any
proposed information collection burden
‘‘for small business concerns with fewer
than 25 employees,’’ pursuant to the
Small Business Paperwork Relief Act of
2002, Public Law 107–198, see 44 U.S.C.
3506(c)(4). Provisions of the Regulatory
Flexibility Act of 1980, 5 U.S.C. 601–
612, do not apply to this proceeding.
The Commission will send a copy of
this Report and Order in a report to be
sent to Congress and the Government
Accountability Office pursuant to the
Congressional Review Act, see 5 U.S.C.
801(a)(1)(A).
List of Subjects in 47 CFR Part 73
Television.
Federal Communications Commission.
Thomas Horan,
Chief of Staff, Media Bureau.
Final Rule
For the reasons discussed in the
preamble, the Federal Communications
Commission amends 47 CFR part 73 as
follows:
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Agencies
[Federal Register Volume 89, Number 51 (Thursday, March 14, 2024)]
[Rules and Regulations]
[Pages 18549-18553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05434]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0850; FRL-11811-01-OCSPP]
Cloquintocet-mexyl in Pesticide Formulations; Tolerances for
Residues
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends the tolerance expression for residues
of the safener cloquintocet-mexyl (acetic acid, [(5-chloro-8-
quinolinyl)oxy]-, 1-methylhexyl ester) (CAS Reg. No. 99607-70-2) and
its acid metabolite (5-chloro-8-quinlinoxyacetic acid) by removing the
active ingredients listed in the tolerance expression so that the
safener can be used in any herbicide formulation applied to the listed
commodities. Corteva Agriscience submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the revision
to the tolerance expression for residues of the safener cloquintocet-
mexyl. There is no change to the numerical tolerances or the listed
commodities.
DATES: This regulation is effective March 14, 2024. Objections and
requests for hearings must be received on or before May 13, 2024 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0850, 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 the OPP docket is (202) 566-1744. Please review the
visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: 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:
[email protected].
[[Page 18550]]
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Federal Register Office's e-CFR site at https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2022-0850 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
May 13, 2024. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2022-0850, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/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 December 19, 2023 (88 FR 87733, FRL-
10579-11-OSCPP), EPA issued a document pursuant to FFDCA section 408,
21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11655) by Corteva Agriscience, 9330 Zionsville Road, Indianapolis, IN
46268. The petition requested that the tolerance expression under 40
CFR 180.560 for the safener cloquintocet-mexyl (acetic acid, [(5-
chloro-8-quinolinyl)oxy]-, 1-methylhexyl ester) (CAS Reg. No. 99607-70-
2) and its acid metabolite (5-chloro-8-quinlinoxyacetic acid), be
amended to remove the active ingredients listed. There was no proposed
change to the numerical tolerances or the listed commodities. This
change would permit the use of the safener, cloquintocet-mexyl, in any
herbicide formulation applied to the listed commodities in accordance
with the established numerical tolerances. That document referenced a
summary of the petition prepared by Corteva Agriscience, which is
available in the docket at https://www.regulations.gov. There were no
comments received in response to the notice of filing.
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. When
making a safety determination for a tolerance, 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. . . .'' Section 408(b)(2)(D) lists other
factors for EPA's consideration in making safety determinations,
including, for example, the validity, completeness, and reliability of
available data, nature of toxic effects, available information
concerning the cumulative effects of the pesticide chemical and other
substances with a common mechanism of toxicity, and available
information concerning aggregate exposure levels to the pesticide
chemical and other related substances.
EPA establishes tolerances only in those cases where it can be
clearly demonstrated that the risks from aggregate exposure to
pesticide chemical residues under reasonably foreseeable circumstances
will pose no harm to human health. In order to determine the risks from
aggregate exposure to pesticide inert ingredients, the Agency considers
the toxicity of the inert in conjunction with possible exposure to
residues of the inert ingredient through food, drinking water, and
through other exposures that occur as a result of pesticide use in
residential settings. If EPA is able to determine that a finite
tolerance is not necessary to ensure that there is a reasonable
certainty that no harm will result from aggregate exposure to the inert
ingredient, an exemption from the requirement of a tolerance may be
established.
Consistent with FFDCA section 408(b)(2)(A), and the factors
specified in FFDCA section 408(b)(2)(C) and (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 cloquintocet-mexyl,
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
cloquintocet-mexyl follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings for the same chemical.
Where scientific information concerning a particular
[[Page 18551]]
chemical remains unchanged, the content of those sections would not
vary between tolerance rulemakings, and EPA considers referral back to
those sections as sufficient to provide an explanation of the
information EPA considered in making its safety determination for the
new rulemaking.
EPA has previously published tolerance rulemakings for
cloquintocet-mexyl in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to cloquintocet-mexyl and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from these rulemakings as described
further in this rulemaking, as they remain unchanged.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
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. For a discussion of the toxicological profile of
cloquintocet-mexyl, please see Unit III.A. of the final rule published
in the Federal Register of December 16, 2005 (70 FR 74679) (FRL-7753-
4), in which the Agency presented the available toxicity data for
cloquintocet-mexyl. There have been no changes to that toxicity data,
and a summary is presented below.
The toxicity database is sufficient for cloquintocet-mexyl.
Cloquintocet-mexyl exhibits low levels of acute toxicity via the oral,
dermal, and inhalation routes of exposure. It is not a skin irritant
but is a skin sensitizer. It is slightly irritating to the eyes.
Although fetal effects were seen in a reproductive and
developmental study, they were seen at maternally toxic doses;
therefore, there is no concern for offspring susceptibility. Available
studies show no evidence of neurotoxicity. Cloquintocet-mexyl is not
genotoxic and is classified as ``not likely to be a human carcinogen.''
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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
The hazard profile of cloquintocet-mexyl is adequately defined. An
acute reference dose (RfD) was selected for the subpopulation of
females 13-50 years old of 1 mg/kg/day (NOAEL of 100 mg/kg/day) from a
developmental toxicity in rats (MRID 44387429) where an increased
incidence of skeletal variants and decreased fetal body weight was
observed in the presence of maternal toxicity at 400 mg/kg/day. An
acute RfD for the general population was not identified.
The Agency selected a chronic RfD of 0.04 mg/kg/day based on a two-
year combined chronic/oncogenicity study in rats (MRID 44387431). In
this study, the NOAEL of 4.3 mg/kg/day was based on increased incidence
of thyroid follicular epithelial hyperplasia in females at 41.2 mg/kg/
day (LOAEL).
C. Exposure Assessment
To determine if removal of the active ingredients from the
tolerance expression would affect residue levels of cloquintocet-mexyl,
EPA relied on various residue trials on wheat and barley conducted with
5 different herbicides. EPA found, based on consistent results from
these studies, that regardless of the chemical or class of chemistry,
the residue profile does not change for cloquintocet-mexyl. These
residues consistently remained below the currently established
tolerances for those commodities.
Based on a review of the data, there is no expected increase in
residue levels associated with removing the active ingredients from the
tolerance expression. Since no change is being made to the numerical
tolerances or the listed commodities, there is no expected change in
dietary exposure.
1. Dietary exposure from food and feed uses. Dietary exposure has
already been assessed based on the conservative assumption that all
three commodities for which there are currently established tolerances
(i.e., wheat, barley, and teff) are treated with cloquintocet-mexyl at
tolerance-level residues. These residue levels have been found by the
Agency to be safe. For a discussion of the dietary exposure to
cloquintocet-mexyl, please see Unit III.C. of the final rule published
in the Federal Register of August 2, 2016 (81 FR 50630) (FRL-9947-78),
Unit III. of the final rule published in the Federal Register of March
22, 2017 (82 FR 14620) (FRL-9959-11), and Unit III. of the final rule
published in the Federal Register of September 11, 2018 (83 FR 45841)
(FRL-9980-90).
2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables). There
are currently no registered uses for products containing cloquintocet-
mexyl that would result in residential exposures.
3. 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 cloquintocet-mexyl to share a common mechanism of
toxicity with any other substances, and cloquintocet-mexyl does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this final rule, therefore, EPA has assumed that
cloquintocet-mexyl 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. Additional Safety Factor for the Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
[[Page 18552]]
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. 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.
EPA has concluded that the FQPA safety factor can be removed for
cloquintocet-mexyl for the following reasons. The toxicology database
is complete for cloquintocet-mexyl. There is no indication of
quantitative or qualitative increased susceptibility of rats or rabbits
to in utero and/or postnatal exposure to cloquintocet-mexyl in the
available toxicity data, and EPA has determined that a developmental
neurotoxicity study is not required for cloquintocet-mexyl. The dietary
(food and drinking water) exposure assessments will not underestimate
the potential exposures for infants and children from the use of
cloquintocet-mexyl. Currently there are no proposed residential uses,
and therefore non-occupational exposure is not expected.
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 cloquintocet-mexyl will occupy less than one percent (<1%) of the
aPAD for females aged 13-49, 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
cloquintocet-mexyl from food and water will utilize <1% of the cPAD for
all subpopulations. There are no residential uses for cloquintocet-
mexyl.
3. Short- and intermediate-term risk. Because cloquintocet-mexyl is
not registered for use in pesticide formulations that will result in
residential exposure, EPA concludes that cloquintocet-mexyl will not
pose a short-term or intermediate-term risk.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity, cloquintocet-mexyl is not expected to pose
a cancer risk to humans.
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 cloquintocet-mexyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, chromatography with ultraviolet
detection (HPLC-UV) for cloquintocet-mexyl and its acid metabolite, 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: [email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). Codex 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 cloquintocet-mexyl (acetic
acid, [(5- chloro-8-quiniolinyl)oxy]-, 1- methylhexyl ester) or its
acid metabolite.
V. Conclusion
Therefore, EPA is removing the active ingredients: clodinafop-
propargyl (wheat only), dicamba (wheat only), flucarbazone-sodium
(wheat only), halauxifen-methyl (wheat or barley), pinoxaden (wheat or
barley), pyroxsulam (wheat or teff), florasulam (teff), or fluroxypyr
1-methylheptyl ester (teff) listed in the tolerance expression for
cloquintocet-mexyl.
VI. Statutory and Executive Order Reviews
This action amends a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled
[[Page 18553]]
``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).
VIII. 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: March 11, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, the EPA amends
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. In Sec. 180.560:
0
a. Revise paragraph (a) introductory text; and
0
b. Add the table heading ``Table 1 to Paragraph (a)''.
The revision and addition reads as follows:
Sec. 180.560 Cloquintocet-mexyl; tolerances for residues.
(a) General. Tolerances are established for residues of the inert
ingredient cloquintocet-mexyl, including its metabolites and
degradates, in or on the commodities in the following table when used
as a safener in herbicide formulations. Compliance with the tolerance
levels specified is to be determined by measuring the combined residues
of cloquintocet-mexyl, (acetic acid [(5-chloro-8-quinolinyl)oxy]-, 1-
methylhexyl ester; CAS Reg. No. 99607-70-2) and its acid metabolite (5-
chloro-8-quinolinoxyacetic acid), expressed as cloquintocet-mexyl, in
or on the following commodities:
Table 1 to Paragraph (a)
* * * * *
[FR Doc. 2024-05434 Filed 3-13-24; 8:45 am]
BILLING CODE 6560-50-P