Cyflumetofen; Pesticide Tolerances, 40396-40399 [2024-10187]
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40396
Federal Register / Vol. 89, No. 92 / Friday, May 10, 2024 / Rules and Regulations
3. In § 180.920, amend table 1 to
180.920 by adding, in alphabetical
order, an entry for ‘‘1-Propanaminium,
3-amino-N-(carboxymethyl)-N,N-
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
dimethyl-, N-coco acyl derivatives,
hydroxides, inner salts (CAS Reg. No.
61789–40–0)’’ to read as follows:
*
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TABLE 1 TO 180.920
Inert ingredients
Limits
*
*
*
1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco
acyl derivatives, hydroxides, inner salts (CAS Reg. No. 61789–40–
0).
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10% w/w in pesticide formulation ..
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[FR Doc. 2024–10182 Filed 5–9–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2022–0887; FRL–11734–01–
OCSPP]
Cyflumetofen; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of cyflumetofen
in or on the following raw agricultural
commodities: berry, low growing,
subgroup 13–07G; fruit, small, vine
climbing, except fuzzy kiwifruit,
subgroup 13–07F; and vegetable,
cucurbit, group 9. The Interregional
Research Project Number 4 (IR–4)
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
This regulation is effective May
10, 2024. Objections and requests for
hearings must be received on or before
July 9, 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).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2022–0887, 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
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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/.
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.
SUPPLEMENTARY 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 EPA’s tolerance
regulations at 40 CFR part 180 through
the Office of the Federal Register’s eCFR site at https://www.ecfr.gov//.
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
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Surfactant.
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I. General Information
SUMMARY:
ADDRESSES:
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Uses
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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–2022–0887 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 July
9, 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–
2022–0887, 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/.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/.
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Federal Register / Vol. 89, No. 92 / Friday, May 10, 2024 / Rules and Regulations
II. Summary of Petitioned-For
Tolerance
In the Federal Register of February
23, 2023 (88 FR 11401) (FRL–10579–01–
OCSPP), EPA issued a document
pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing
of pesticide petition (PP 2E9030) by the
Interregional Research Project No. 4 (IR–
4), North Carolina State University,
1730 Varsity Drive, Venture IV, Suite
210, Raleigh, NC 27606. The petition
requests to amend 40 CFR 180.677 by
establishing tolerances for residues of
cyflumetofen (2-methoxyethyl a-cyanoa-[4-(1,1-dimethylethyl)phenyl]-b-oxo2-(trifluoromethyl)benzenepropanoate),
including its metabolites and
degradates, in or on the following raw
agricultural commodities: berry, low
growing, subgroup 13–07G at 0.6 parts
per million (ppm); fruit, small, vine
climbing, except fuzzy kiwifruit,
subgroup 13–07F at 0.6 ppm; and
vegetable, cucurbit, group 9 at 2 ppm.
Upon the establishment of these
tolerances, IR–4 requested that EPA
remove the existing tolerances in 40
CFR 180.677 for residues of
cyflumetofen (2-methoxyethyl a-cyanoa-[4-(1,1-dimethylethyl)phenyl]-b-oxo2-(trifluoromethyl)benzenepropanoate)
in or on cucumber at 0.3 ppm; grape at
0.60 ppm; and strawberry at 0.6 ppm.
That document referenced a summary of
the petition prepared by IR–4, which is
available in the docket at https://
www.regulations.gov. One comment was
received in response to 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 and in
accordance with its authority under
FFDCA section 408(d)(4)(A)(i), EPA is
establishing one tolerance at a different
level than petitioned-for. The reason for
this change is explained in Unit IV.D.
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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
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give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified
therein, EPA has reviewed the available
scientific data and other relevant
information in support of this action.
EPA has sufficient data to assess the
hazards of and to make a determination
on aggregate exposure for cyflumetofen
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with cyflumetofen 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 pesticide chemical. Where
scientific information concerning a
particular 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 cyflumetofen
in which EPA concluded, based on the
available information, that there is a
reasonable certainty that no harm would
result from aggregate exposure to
cyflumetofen 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.
Toxicological profile. For a discussion
of the Toxicological Profile of
cyflumetofen, see Unit III.A. of the final
rule published in the Federal Register
of May 8, 2019 (84 FR 20037) (FRL–
9990–60).
Toxicological points of departure/
Levels of concern. A summary of the
toxicological endpoints for cyflumetofen
used for human health risk assessment
is discussed in Unit III.B. of the May 8,
2019, rulemaking.
Exposure assessment. EPA’s dietary
exposure assessments have been
updated to include the additional
exposures from the petitioned-for
tolerances. No acute dietary exposure
and risk analyses were performed since
there were no appropriate toxicological
effects attributable to a single dose
observed in available toxicity studies for
either the general population or for
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females 13 to 49 years of age. The
chronic dietary (food and drinking
water) exposure and risk assessment for
cyflumetofen was conducted using the
Dietary Exposure Evaluation Model
software with the Food Commodity
Intake Database (DEEM–FCID) Version
4.02. This software uses 2005–2010 food
consumption data from the U.S.
Department of Agriculture’s (USDA’s)
National Health and Nutrition
Examination Survey/What We Eat in
America, (NHANES/WWEIA). An
unrefined chronic dietary (food and
drinking water) analysis was conducted
using tolerance-level residues, default
processing factors, empirical processing
factors, and 100% crop treated
assumptions.
Drinking water exposure. EPA has
revised the cyflumetofen drinking water
assessment (DWA) since the May 8,
2019, final rule and the final rule
published in the Federal Register of
December 6, 2021 (86 FR 68915) (FRL–
9234–01–OCSPP). The DWA provides
updated estimated drinking water
concentrations (EDWCs) for
cyflumetofen residues of concern in
surface water and groundwater. The use
patterns for current and proposed uses
were modeled using new pesticide in
water calculator scenarios. The updated
EDWCs for use in human health risk
assessment are 0.59 mg/L for acute
exposures, 0.11 mg/L for non-cancer
chronic exposures and 0.10 mg/L for
cancer exposures generated from
exposure in surface water.
Non-occupational exposure. There are
no new proposed residential (nonoccupational) uses for cyflumetofen at
this time; however, there are registered
uses of cyflumetofen on commercial
vegetable gardens and ornamental
plants. EPA’s residential exposure
assessment has changed since the May
8, 2019, final rule based on a revised
practice. Because all current
cyflumetofen labels require handlers to
wear personal protective equipment,
EPA assumes that cyflumetofen is
applied by professional applicators, not
residential (homeowner) applicators.
Therefore, the current assessment does
not consider exposure to residential
handlers or exposure from direct
homeowner applications to ornamentals
or home gardens.
There are registered uses of
cyflumetofen to commercially treat
garden vegetables that could be
subsequently purchased at a retail
location for transplant into a residential
setting and treated ornamental plants
that can be purchased by consumers.
EPA considers post-application
exposure resulting from this scenario to
be negligible because residues are
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expected to decline significantly during
the time from application in a
commercial setting to consumer
purchase at a retail location. Also, there
is no dermal hazard for cyflumetofen
since no systemic effects were observed
in the dermal study up to the limit dose.
Therefore, a quantitative residential
post-application dermal risk assessment
is not required.
Cumulative exposures. 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 cyflumetofen and
any other substances and cyflumetofen
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
action, therefore, EPA has not assumed
that cyflumetofen has a common
mechanism of toxicity with other
substances.
Safety factor for infants and children.
EPA continues to conclude that there
are reliable data to support the
reduction of the Food Quality Protection
Act (FQPA) safety factor from 10X to
1X. See Unit III.D. of the May 8, 2019,
rulemaking for a discussion of the
Agency’s rationale for that
determination.
Aggregate risk and Determination of
safety. EPA determines whether acute
and chronic dietary pesticide exposures
are safe by comparing dietary exposure
estimates to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD).
Short-, intermediate-, and chronic-term
risks are evaluated by comparing the
estimated total food, water, and
residential exposure to the appropriate
points of departure (PODs) to ensure
that an adequate margin of exposure
(MOE) exists.
An acute dietary risk assessment was
not conducted as toxicological effects
attributable to a single dose were not
identified. Therefore, cyflumetofen is
not expected to pose an acute risk.
Chronic dietary risks are below the
Agency’s level of concern of 100% of
the cPAD; the chronic dietary exposure
estimate for all infants, the most highly
exposed population subgroup, is 7.6%
of the cPAD. Because EPA has
determined that there are no residential
exposures, the chronic dietary risk is the
same as the overall chronic aggregate
risk for cyflumetofen and is not of
concern.
As stated in Unit III.A. of the May 8,
2019, final rule, EPA concluded that the
nonlinear approach for assessing
potential cancer risk is appropriate. The
chronic risk resulting from aggregate
exposure to cyflumetofen is below the
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Agency’s level of concern; therefore, the
Agency concludes that there is not a
cancer risk of concern from exposure to
cyflumetofen.
Therefore, based on the risk
assessments and information described
above, 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 cyflumetofen residues.
More detailed information on this action
can be found in the document titled
‘‘Cyflumetofen. Human Health Risk
Assessment for the Proposed New Use
on Vegetable, Cucurbit, Group 9, Label
Amendment for Vegetable, Fruiting,
Group 8–10, and Crop Group Expansion
of Berry, Low Subgroup 13–07G and
Fruit, Small, Vine Climbing, Except
Fuzzy Kiwifruit, subgroup 13–07F.’’ in
docket ID number EPA–HQ–OPP–2022–
0887.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available
analytical enforcement method, see Unit
IV.A. of the final rule published in the
Federal Register of July 1, 2020 (85 FR
39491) (FRL–10009–25).
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 has not established an MRL for
residues of cyflumetofen in or on
cucurbit vegetable group 9, bell pepper
or non-bell pepper. Codex has
established MRLs for residues of
cyflumetofen in or on strawberry at 0.6
ppm and in or on grape, table and grape,
wine at 0.6 ppm. The U.S. tolerances for
berry, low growing, subgroup 13–07G
and fruit, small, vine climbing, except
fuzzy kiwifruit, subgroup 13–07F are
being established at 0.6 ppm and are
harmonized with the relevant Codex
MRLs.
C. Response to Comments
One comment was received on the
notice of filing. The comment is an
inquiry from the People’s Republic of
China, requesting that EPA explain the
reasons for removing the existing
tolerances for strawberries and grapes
and establishing new crop group
tolerances for berry, low growing,
subgroup 13–07G and fruit, small, vine
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climbing, except fuzzy kiwifruit,
subgroup 13–07F, thus expanding
tolerance coverage for these crops. The
commenter also requested that the
Agency provide the test data used for
risk assessment of the relevant fruits.
Under FFDCA section 408, EPA is
authorized to establish tolerances for
pesticide chemical residues in food.
EPA establishes tolerances for each
pesticide based on data on the pesticide
residues and assesses the potential risks
to human health posed by that
pesticide. A tolerance is the maximum
permissible residue level established for
a pesticide in raw agricultural
commodities and processed foods. The
crop group regulations currently in 40
CFR 180.40 and 180.41 enable the
establishment of tolerances for a group
of crops based on residue data for
certain crops that are representative of
the group. Strawberry is a representative
crop for the crop subgroup 13–07G, and
grape is a representative crop for the
crop subgroup 13–07F.
The data supporting the strawberry
and grape tolerances were submitted to
the Agency and were reviewed and
reported in the document titled
‘‘Cyflumetofen. Petition for the
Establishment of Permanent Tolerances
and Registration for Use on Citrus (Crop
Group 10–10), Pome Fruits (Crop Group
11–10), Tree Nuts (Crop Group 14–12),
Grape, Strawberry, and Tomato.
Summary of Analytical Chemistry and
Residue Data.’’, D408531, D. Wilbur, 09July-2013. In the current action, EPA is
expanding the grape tolerance to fruit,
small, vine climbing, except fuzzy
kiwifruit, subgroup 13–07F and
expanding the strawberry tolerance to
berry, low growing, subgroup 13–07G as
stated in the document ‘‘Cyflumetofen.
Proposed Section 3 Registration for the
New Use on Vegetable Cucurbit, Group
9, Label Amendment for Vegetable,
Fruiting, Group 8–10, and Crop Group
Expansion of Berry, Low Subgroup 13–
07G and Fruit, Small, Vine Climbing,
Except Fuzzy Kiwifruit, Subgroup 13–
07F. Summary of Analytical Chemistry
and Residue Data’’ and the document
‘‘Cyflumetofen. Human Health Risk
Assessment for the Proposed New Use
on Vegetable, Cucurbit, Group 9, Label
Amendment for Vegetable, Fruiting,
Group 8–10, and Crop Group Expansion
of Berry, Low Subgroup 13–07G and
Fruit, Small, Vine Climbing, Except
Fuzzy Kiwifruit, subgroup 13–07F.’’ All
three documents can be found in docket
ID number EPA–HQ–OPP–2022–0887.
D. Revisions to Petitioned-For
Tolerances
EPA reviewed the available residue
data and is establishing the tolerance for
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resides of cyflumetofen in or on
vegetable, cucurbit, group 9 at 0.3 ppm
rather than at 2 ppm as IR–4 requested.
IR–4 calculated the tolerance of 2 ppm
by including the metabolite B–1 in the
residue levels. However, the only
residues included in the tolerance
expression are for the parent compound,
cyflumetofen. Using the residues for
cyflumetofen but not metabolite B–1,
EPA calculated the tolerance for resides
of cyflumetofen in or on vegetable,
cucurbit, group 9 to be 0.06 ppm, which
is covered by the established tolerance
of 0.3 ppm in or on cucumber.
Therefore, EPA is establishing the
tolerance for residues of cyflumetofen in
or on vegetable, cucurbit, group 9 at 0.3
ppm.
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V. Conclusion
Therefore, tolerances are established
for residues of cyflumetofen: (2methoxyethyl a-cyano-a-[4-(1,1dimethylethyl)phenyl]-b-oxo-2(trifluoromethyl)benzenepropanoate),
including its metabolites and
degradates, in or on berry, low growing,
subgroup 13–07G at 0.6 ppm; fruit,
small, vine climbing, except fuzzy
kiwifruit, subgroup 13–07F at 0.6 ppm;
and vegetable, cucurbit, group 9 at 0.3
ppm. EPA is removing the established
tolerances for strawberry at 0.6 ppm;
grape at 0.60 ppm; and cucumber at 0.3
ppm as unnecessary upon the
establishment of the new tolerances.
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
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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).
Dated: May 6, 2024.
Charles Smith,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.677, amend table 1 to
paragraph (a) by:
■ a. Adding in alphabetical order an
entry for ‘‘Berry, low growing, subgroup
13–07G’’;
■ b. Removing the entry for
‘‘Cucumber’’;
■ c. Adding in alphabetical order an
entry for ‘‘Fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13–
07F’’;
■ d. Removing the entries for ‘‘Grape’’
and ‘‘Strawberry’’; and
■ e. Adding in alphabetical order an
entry for ‘‘Vegetable, cucurbit, group 9’’.
The additions read as follows:
■
§ 180.677 Cyflumetofen; tolerance for
residues.
(a) * * *
TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
*
*
*
*
Berry, low growing, subgroup
13–07G ...................................
*
*
*
*
*
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13–07F ....................................
*
*
*
*
*
Vegetable, cucurbit, group 9 ......
*
0.6
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).
*
*
*
BILLING CODE 6560–50–P
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
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[FR Doc. 2024–10187 Filed 5–9–24; 8:45 am]
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Agencies
[Federal Register Volume 89, Number 92 (Friday, May 10, 2024)]
[Rules and Regulations]
[Pages 40396-40399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10187]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0887; FRL-11734-01-OCSPP]
Cyflumetofen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
cyflumetofen in or on the following raw agricultural commodities:
berry, low growing, subgroup 13-07G; fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F; and vegetable, cucurbit, group
9. The Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 10, 2024. Objections and
requests for hearings must be received on or before July 9, 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-2022-0887, 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/.
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].
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 EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov//.
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-2022-0887 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
July 9, 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-2022-0887, 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/.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/.
[[Page 40397]]
II. Summary of Petitioned-For Tolerance
In the Federal Register of February 23, 2023 (88 FR 11401) (FRL-
10579-01-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide
petition (PP 2E9030) by the Interregional Research Project No. 4 (IR-
4), North Carolina State University, 1730 Varsity Drive, Venture IV,
Suite 210, Raleigh, NC 27606. The petition requests to amend 40 CFR
180.677 by establishing tolerances for residues of cyflumetofen (2-
methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-dimethylethyl)phenyl]-
[beta]-oxo-2-(trifluoromethyl)benzenepropanoate), including its
metabolites and degradates, in or on the following raw agricultural
commodities: berry, low growing, subgroup 13-07G at 0.6 parts per
million (ppm); fruit, small, vine climbing, except fuzzy kiwifruit,
subgroup 13-07F at 0.6 ppm; and vegetable, cucurbit, group 9 at 2 ppm.
Upon the establishment of these tolerances, IR-4 requested that EPA
remove the existing tolerances in 40 CFR 180.677 for residues of
cyflumetofen (2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-
dimethylethyl)phenyl]-[beta]-oxo-2-(trifluoromethyl)benzenepropanoate)
in or on cucumber at 0.3 ppm; grape at 0.60 ppm; and strawberry at 0.6
ppm. That document referenced a summary of the petition prepared by IR-
4, which is available in the docket at https://www.regulations.gov. One
comment was received in response to 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 and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is establishing one tolerance at a different level than petitioned-for.
The reason for this change 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. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for cyflumetofen including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with cyflumetofen 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 pesticide
chemical. Where scientific information concerning a particular 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 cyflumetofen
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to cyflumetofen 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.
Toxicological profile. For a discussion of the Toxicological
Profile of cyflumetofen, see Unit III.A. of the final rule published in
the Federal Register of May 8, 2019 (84 FR 20037) (FRL-9990-60).
Toxicological points of departure/Levels of concern. A summary of
the toxicological endpoints for cyflumetofen used for human health risk
assessment is discussed in Unit III.B. of the May 8, 2019, rulemaking.
Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional exposures from the petitioned-for
tolerances. No acute dietary exposure and risk analyses were performed
since there were no appropriate toxicological effects attributable to a
single dose observed in available toxicity studies for either the
general population or for females 13 to 49 years of age. The chronic
dietary (food and drinking water) exposure and risk assessment for
cyflumetofen was conducted using the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-FCID) Version
4.02. This software uses 2005-2010 food consumption data from the U.S.
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey/What We Eat in America, (NHANES/WWEIA). An unrefined
chronic dietary (food and drinking water) analysis was conducted using
tolerance-level residues, default processing factors, empirical
processing factors, and 100% crop treated assumptions.
Drinking water exposure. EPA has revised the cyflumetofen drinking
water assessment (DWA) since the May 8, 2019, final rule and the final
rule published in the Federal Register of December 6, 2021 (86 FR
68915) (FRL-9234-01-OCSPP). The DWA provides updated estimated drinking
water concentrations (EDWCs) for cyflumetofen residues of concern in
surface water and groundwater. The use patterns for current and
proposed uses were modeled using new pesticide in water calculator
scenarios. The updated EDWCs for use in human health risk assessment
are 0.59 [mu]g/L for acute exposures, 0.11 [mu]g/L for non-cancer
chronic exposures and 0.10 [mu]g/L for cancer exposures generated from
exposure in surface water.
Non-occupational exposure. There are no new proposed residential
(non-occupational) uses for cyflumetofen at this time; however, there
are registered uses of cyflumetofen on commercial vegetable gardens and
ornamental plants. EPA's residential exposure assessment has changed
since the May 8, 2019, final rule based on a revised practice. Because
all current cyflumetofen labels require handlers to wear personal
protective equipment, EPA assumes that cyflumetofen is applied by
professional applicators, not residential (homeowner) applicators.
Therefore, the current assessment does not consider exposure to
residential handlers or exposure from direct homeowner applications to
ornamentals or home gardens.
There are registered uses of cyflumetofen to commercially treat
garden vegetables that could be subsequently purchased at a retail
location for transplant into a residential setting and treated
ornamental plants that can be purchased by consumers. EPA considers
post-application exposure resulting from this scenario to be negligible
because residues are
[[Page 40398]]
expected to decline significantly during the time from application in a
commercial setting to consumer purchase at a retail location. Also,
there is no dermal hazard for cyflumetofen since no systemic effects
were observed in the dermal study up to the limit dose. Therefore, a
quantitative residential post-application dermal risk assessment is not
required.
Cumulative exposures. 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
cyflumetofen and any other substances and cyflumetofen does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this action, therefore, EPA has not assumed that
cyflumetofen has a common mechanism of toxicity with other substances.
Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit
III.D. of the May 8, 2019, rulemaking for a discussion of the Agency's
rationale for that determination.
Aggregate risk and Determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
dietary exposure estimates to the acute population adjusted dose (aPAD)
and chronic population adjusted dose (cPAD). Short-, intermediate-, and
chronic-term risks are evaluated by comparing the estimated total food,
water, and residential exposure to the appropriate points of departure
(PODs) to ensure that an adequate margin of exposure (MOE) exists.
An acute dietary risk assessment was not conducted as toxicological
effects attributable to a single dose were not identified. Therefore,
cyflumetofen is not expected to pose an acute risk. Chronic dietary
risks are below the Agency's level of concern of 100% of the cPAD; the
chronic dietary exposure estimate for all infants, the most highly
exposed population subgroup, is 7.6% of the cPAD. Because EPA has
determined that there are no residential exposures, the chronic dietary
risk is the same as the overall chronic aggregate risk for cyflumetofen
and is not of concern.
As stated in Unit III.A. of the May 8, 2019, final rule, EPA
concluded that the nonlinear approach for assessing potential cancer
risk is appropriate. The chronic risk resulting from aggregate exposure
to cyflumetofen is below the Agency's level of concern; therefore, the
Agency concludes that there is not a cancer risk of concern from
exposure to cyflumetofen.
Therefore, based on the risk assessments and information described
above, 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 cyflumetofen residues. More detailed information
on this action can be found in the document titled ``Cyflumetofen.
Human Health Risk Assessment for the Proposed New Use on Vegetable,
Cucurbit, Group 9, Label Amendment for Vegetable, Fruiting, Group 8-10,
and Crop Group Expansion of Berry, Low Subgroup 13-07G and Fruit,
Small, Vine Climbing, Except Fuzzy Kiwifruit, subgroup 13-07F.'' in
docket ID number EPA-HQ-OPP-2022-0887.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the final rule published in the Federal Register of
July 1, 2020 (85 FR 39491) (FRL-10009-25).
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 has not established an MRL for residues of cyflumetofen in or
on cucurbit vegetable group 9, bell pepper or non-bell pepper. Codex
has established MRLs for residues of cyflumetofen in or on strawberry
at 0.6 ppm and in or on grape, table and grape, wine at 0.6 ppm. The
U.S. tolerances for berry, low growing, subgroup 13-07G and fruit,
small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F are being
established at 0.6 ppm and are harmonized with the relevant Codex MRLs.
C. Response to Comments
One comment was received on the notice of filing. The comment is an
inquiry from the People's Republic of China, requesting that EPA
explain the reasons for removing the existing tolerances for
strawberries and grapes and establishing new crop group tolerances for
berry, low growing, subgroup 13-07G and fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F, thus expanding tolerance
coverage for these crops. The commenter also requested that the Agency
provide the test data used for risk assessment of the relevant fruits.
Under FFDCA section 408, EPA is authorized to establish tolerances
for pesticide chemical residues in food. EPA establishes tolerances for
each pesticide based on data on the pesticide residues and assesses the
potential risks to human health posed by that pesticide. A tolerance is
the maximum permissible residue level established for a pesticide in
raw agricultural commodities and processed foods. The crop group
regulations currently in 40 CFR 180.40 and 180.41 enable the
establishment of tolerances for a group of crops based on residue data
for certain crops that are representative of the group. Strawberry is a
representative crop for the crop subgroup 13-07G, and grape is a
representative crop for the crop subgroup 13-07F.
The data supporting the strawberry and grape tolerances were
submitted to the Agency and were reviewed and reported in the document
titled ``Cyflumetofen. Petition for the Establishment of Permanent
Tolerances and Registration for Use on Citrus (Crop Group 10-10), Pome
Fruits (Crop Group 11-10), Tree Nuts (Crop Group 14-12), Grape,
Strawberry, and Tomato. Summary of Analytical Chemistry and Residue
Data.'', D408531, D. Wilbur, 09-July-2013. In the current action, EPA
is expanding the grape tolerance to fruit, small, vine climbing, except
fuzzy kiwifruit, subgroup 13-07F and expanding the strawberry tolerance
to berry, low growing, subgroup 13-07G as stated in the document
``Cyflumetofen. Proposed Section 3 Registration for the New Use on
Vegetable Cucurbit, Group 9, Label Amendment for Vegetable, Fruiting,
Group 8-10, and Crop Group Expansion of Berry, Low Subgroup 13-07G and
Fruit, Small, Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F.
Summary of Analytical Chemistry and Residue Data'' and the document
``Cyflumetofen. Human Health Risk Assessment for the Proposed New Use
on Vegetable, Cucurbit, Group 9, Label Amendment for Vegetable,
Fruiting, Group 8-10, and Crop Group Expansion of Berry, Low Subgroup
13-07G and Fruit, Small, Vine Climbing, Except Fuzzy Kiwifruit,
subgroup 13-07F.'' All three documents can be found in docket ID number
EPA-HQ-OPP-2022-0887.
D. Revisions to Petitioned-For Tolerances
EPA reviewed the available residue data and is establishing the
tolerance for
[[Page 40399]]
resides of cyflumetofen in or on vegetable, cucurbit, group 9 at 0.3
ppm rather than at 2 ppm as IR-4 requested. IR-4 calculated the
tolerance of 2 ppm by including the metabolite B-1 in the residue
levels. However, the only residues included in the tolerance expression
are for the parent compound, cyflumetofen. Using the residues for
cyflumetofen but not metabolite B-1, EPA calculated the tolerance for
resides of cyflumetofen in or on vegetable, cucurbit, group 9 to be
0.06 ppm, which is covered by the established tolerance of 0.3 ppm in
or on cucumber. Therefore, EPA is establishing the tolerance for
residues of cyflumetofen in or on vegetable, cucurbit, group 9 at 0.3
ppm.
V. Conclusion
Therefore, tolerances are established for residues of cyflumetofen:
(2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-dimethylethyl)phenyl]-
[beta]-oxo-2-(trifluoromethyl)benzenepropanoate), including its
metabolites and degradates, in or on berry, low growing, subgroup 13-
07G at 0.6 ppm; fruit, small, vine climbing, except fuzzy kiwifruit,
subgroup 13-07F at 0.6 ppm; and vegetable, cucurbit, group 9 at 0.3
ppm. EPA is removing the established tolerances for strawberry at 0.6
ppm; grape at 0.60 ppm; and cucumber at 0.3 ppm as unnecessary upon the
establishment of the new tolerances.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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: May 6, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.677, amend table 1 to paragraph (a) by:
0
a. Adding in alphabetical order an entry for ``Berry, low growing,
subgroup 13-07G'';
0
b. Removing the entry for ``Cucumber'';
0
c. Adding in alphabetical order an entry for ``Fruit, small, vine
climbing, except fuzzy kiwifruit, subgroup 13-07F'';
0
d. Removing the entries for ``Grape'' and ``Strawberry''; and
0
e. Adding in alphabetical order an entry for ``Vegetable, cucurbit,
group 9''.
The additions read as follows:
Sec. 180.677 Cyflumetofen; tolerance for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Berry, low growing, subgroup 13-07G......................... 0.6
* * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit, 0.6
subgroup 13-07F............................................
* * * * *
Vegetable, cucurbit, group 9................................ 0.3
------------------------------------------------------------------------
* * * * *
[FR Doc. 2024-10187 Filed 5-9-24; 8:45 am]
BILLING CODE 6560-50-P