Cyantraniliprole; Pesticide Tolerances, 42382-42387 [2024-10490]
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cyantraniliprole, including its
metabolites and degradates, in or on
multiple commodities which are
identified and discussed later in this
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document. The Interregional Project
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Number 4 (IR–4) and the FMC
Corporation requested these tolerances
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[Revise the ‘‘Sectional Center Facility’’ under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
line item to read as follows:]
DATES: This regulation is effective May
Sectional Center Facility (SCF)/Local
15, 2024. Objections and requests for
Processing Center (LPC)/Regional
hearings must be received on or before
Processing & Distribution Center
July 15, 2024, and must be filed in
(RPDC), 246.4.0, 246.4.0, 266.5.0,
accordance with the instructions
246.4.0, 266.5.0
provided in 40 CFR part 178 (see also
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Unit I.C. of the SUPPLEMENTARY
INFORMATION).
USPS Marketing Mail, Flats
ADDRESSES: The docket for this action,
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identified by docket identification (ID)
[Revise the entry line items under
‘‘USPS Marketing Mail, flats’’ to read as numbers EPA–HQ–OPP–2023–0078 and
EPA–HQ–OPP–2022–0958, is available
follows:]
online at https://www.regulations.gov or
DNDC/RPDC entry, 246.3.0
in-person at the Office of Pesticide
DDU or S&DC entry, 246.5.0
Programs Regulatory Public Docket
DSCF/LPC entry, 246.4.0
(OPP Docket) in the Environmental
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Protection Agency Docket Center (EPA/
DC), West William Jefferson Clinton
USPS Marketing Mail, Letters
Bldg., Rm. 3334, 1301 Constitution Ave.
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NW, Washington, DC 20460–0001. The
[Revise the entry line items under
Public Reading Room is open from 8:30
‘‘USPS Marketing Mail, letters’’ to read
a.m. to 4:30 p.m., Monday through
as follows:]
Friday, excluding legal holidays. The
DNDC/RPDC entry, 246.3.0
telephone number for the Public
DDU or S&DC entry, 246.5.0
Reading Room and the OPP Docket is
DSCF/LPC entry, 246.4.0
(202) 566–1744. For the latest status
information on EPA/DC services, docket
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access, visit https://www.epa.gov/.
USPS Marketing Mail, Parcels
FOR FURTHER INFORMATION CONTACT:
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Charles Smith, Director, Registration
[Revise the entry line items under
Division (7505T), Office of Pesticide
‘‘USPS Marketing Mail, parcels’’ to read Programs, Environmental Protection
as follows:]
Agency, 1200 Pennsylvania Ave. NW,
DNDC/RPDC entry, 246.3.0
Washington, DC 20460–0001; main
DDU or S&DC entry, 246.5.0
telephone number: (202) 566–1030;
DSCF/RPDC entry, 246.4.0
email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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Network Distribution Center (NDC)/
Regional Processing & Distribution
Center (RPDC) Acceptance
I. General Information
Christopher Doyle,
Attorney, Ethics and Legal Compliance.
A. Does this action apply to me?
[FR Doc. 2024–10668 Filed 5–14–24; 8:45 am]
BILLING CODE 7710–12–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
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[EPA–HQ–OPP–2023–0078 and EPA–HQ–
OPP–2022–0958; FRL–11941–01–OCSPP]
Cyantraniliprole; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
and modifies tolerances for residues of
SUMMARY:
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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 EPA’s tolerance
regulations at 40 CFR part 180 through
the Office of the Federal Register’s eCFR site at https://www.ecfr.gov/
current/title-40.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2023–0078 and EPA–HQ–OPP–
2022–0958 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
15, 2024. Addresses for mail and hand
delivery of objections and hearing
requests are provided in 40 CFR
178.25(b).
EPA’s Office of Administrative Law
Judges (OALJ), in which the Hearing
Clerk is housed, urges parties to file and
serve documents by electronic means
only, notwithstanding any other
particular requirements set forth in
other procedural rules governing those
proceedings. See ‘‘Revised Order Urging
Electronic Service and Filing’’, dated
June 22, 2023, which can be found at
https://www.epa.gov/system/files/
documents/2023-06/2023-06-22%20%20revised%20order%20urging
%20electronic%20filing
%20and%20service.pdf. Although
EPA’s regulations require submission
via U.S. Mail or hand delivery, EPA
intends to treat submissions filed via
electronic means as properly filed
submissions; therefore, EPA believes the
preference for submission via electronic
means will not be prejudicial. When
submitting documents to the OALJ
electronically, a person should utilize
the OALJ e-filing system at https://
yosemite.epa.gov/OA/EAB/EAB-ALJ_
Upload.nsf/HomePage?ReadForm.
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
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objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2023–0078 and EPA–HQ–OPP–2022–
0958, 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.
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 July 26,
2023 (88 FR 48179) (FRL–10579–06–
OCSPP), EPA issued a document
pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing
of a pesticide petition (PP2E9041) 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
requested to amend 40 CFR 180.672 by
establishing tolerances for residues of
cyantraniliprole, including its
metabolites and degradates, in or on the
following commodities: edible podded
bean subgroup 6–22A at 2 parts per
million (ppm); edible podded pea
subgroup 6–22B at 2 ppm; field corn
subgroup 15–22C at 0.01 ppm; forage
and hay of legume vegetables (except
soybeans) subgroup 7–22A at 40 ppm;
herb fresh leaves subgroup 25A at 40
ppm; herb dried leaves subgroup 25B at
150 ppm; hops, dried cones at 70 ppm;
papaya at 1.5 ppm; pulses, dried shelled
bean, except soybean, subgroup 6–22E
at 1 ppm; pulses, dried shelled pea
subgroup 6–22F at 1 ppm; rice subgroup
15–22F at 0.02 ppm; spices crop group
26 at 80 ppm; succulent shelled bean
subgroup 6–22C at 0.3 ppm; succulent
shelled pea subgroup 6–22D at 0.3 ppm;
and sweet corn subgroup 15–22D at 0.01
ppm. The petitioner proposed, upon the
approval of the aforementioned
tolerances, to remove established
tolerances for residues of
cyantraniliprole, including its
metabolites and degradates, in or on the
following commodities: vegetable,
legume, dried shelled, except soybean,
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subgroup 6C at 1.0 ppm; vegetable,
legume, edible podded, subgroup 6A at
2.0 ppm; vegetable, legume, succulent
shelled, subgroup 6B at 0.20 ppm;
vegetable, foliage of legume, except
soybean, group 7A at 40 ppm; corn,
field, grain at 0.01 ppm; corn, pop,
grain, at 0.01 ppm; corn, sweet, kernel
plus cob with husks removed at 0.01
ppm; and rice, grain at 0.02 ppm. That
document referenced a summary of the
petition prepared by IR–4, the
petitioner, which is available in the
docket, https://www.regulations.gov.
There were no comments received on
the notice of filing.
Based upon review of the data
supporting the petition and in
accordance with its authority under
FFDCA section 408(d)(4)(A)(i), EPA has
made modifications to the proposed
commodity definitions for most of the
tolerances in this petition and is not
establishing several of the petitioned-for
tolerances because the petitioner
withdrew them. The reasons for these
changes are explained in Unit IV.D.
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 a pesticide petition (PP2E9032) by the
FMC Corporation, 2929 Walnut Street,
Philadelphia, PA 19104, requesting,
pursuant to section 408(d) of the Federal
Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a(d), to amend 40 CFR part
180 by establishing tolerances for
residues of cyantraniliprole, including
its metabolites and degradates in or on
the following commodities: grape, table
at 2.0 ppm (only for imported table
grapes); avocado at 0.4 ppm (only for
imported avocados); and mango at 0.7
ppm (only for imported mangos) and by
revising the tolerance for imported
olives from 1.5 ppm to 3.0 ppm and,
upon the approval of the
aforementioned tolerances, to remove
established tolerances for residues of
cyantraniliprole, including its
metabolites and degradates, in or on
olive oil at 2 ppm. That document
referenced a summary of the petition
prepared by FMC, the petitioner, which
is available in the docket, https://
www.regulations.gov. A comment was
received on the notice of filing. EPA’s
response to the comment is discussed in
Unit IV.C.
Based upon review of the data
supporting the petition and in
accordance with its authority under
FFDCA section 408(d)(4)(A)(i), EPA has
made modifications to two of the
proposed tolerance values. The reason
for these changes 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
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
cyantraniliprole including exposure
resulting from the tolerances established
by this action. EPA’s assessment of
exposures and risks associated with
cyantraniliprole 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
cyantraniliprole in which EPA
concluded, based on the available
information, that there is a reasonable
certainty that no harm would result
from aggregate exposure to
cyantraniliprole 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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Toxicological profile. For a discussion
of the Toxicological Profile of
cyantraniliprole, see Unit III.A. of the
cyantraniliprole tolerance rulemaking
published in the Federal Register of
November 13, 2018 (83 FR 56262) (FRL–
9985–32).
Toxicological points of departure/
Levels of concern. For a discussion of
the Toxicological Points of Departure/
Levels of Concern used for the safety
assessment of cyantraniliprole, see Unit
III.B of the February 5, 2014, rulemaking
(79 FR 6826) (FRL–9388–7).
Dietary exposure assessment. Much of
the exposure assessment for
cyantraniliprole remains unchanged
from the discussion in Unit III.C of the
November 13, 2018, rulemaking, except
as described below. EPA’s dietary
exposure assessments have been
updated to include the additional
exposures from the tolerances
established since the November 13,
2018, rulemaking and the petitioned-for
tolerances excluding the crop subgroup
expansions to field corn subgroup 15–
22C, sweet corn subgroup 15–22D and
rice subgroup 15–22F. An acute dietary
endpoint was not selected; therefore, an
acute assessment was not performed. A
refined chronic dietary (food and
drinking water) exposure assessment
was conducted using the Dietary
Exposure Evaluation Model-Food
Commodity Intake Database DEEM–
FCID and assuming average field trial
residues or mean residue values from
the United States Department of
Agriculture (USDA) Pesticide Data
Program (PDP), empirical processing
factors and/or HED’s default processing
factors and assumed 100 percent crop
treated (PCT). In some cases, data were
translated from representative
commodities of their crop group.
Anticipated residue information.
Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and
information on the anticipated residue
levels of pesticide residues in food and
the actual levels of pesticide residues
that have been measured in food. If EPA
relies on such information, EPA must
require pursuant to FFDCA section
408(f)(1) that data be provided 5 years
after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. For the present
action, EPA will issue such data call-ins
as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances.
Drinking water and non-occupational
exposures. The estimated drinking
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water concentrations (EDWCs) have not
changed since the 2018 rulemaking. For
a detailed summary of the drinking
water analysis for cyantraniliprole used
for the human health risk assessment,
see Unit III.C.2. of the November 13,
2018, tolerance rulemaking. There are
no proposed residential uses or
proposed uses intended for use by
occupational handlers in residential
settings for this action. However, there
are residential exposures from currently
registered uses of cyantraniliprole
which have been previously assessed.
The registered residential uses and
exposures that are incorporated into the
aggregate assessment are described in
Unit III.C.3 of the November 13, 2018,
final rule.
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 cyantraniliprole
and any other substances and
cyantraniliprole does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
not assumed that cyantraniliprole has a
common mechanism of toxicity with
other substances.
In 2016, EPA’s Office of Pesticide
Programs released a guidance document
entitled, Pesticide Cumulative Risk
Assessment: Framework for Screening
Analysis https://www.epa.gov/pesticidescience-and-assessing-pesticide-risks/
pesticide-cumulative-risk-assessmentframework. This document provides
guidance on how to screen groups of
pesticides for cumulative evaluation
using a two-step approach beginning
with the evaluation of available
toxicological information and if
necessary, followed by a risk-based
screening approach. This framework
supplements the existing guidance
documents for establishing common
mechanism groups (CMG) and
conducting cumulative risk
assessments.
Cyantraniliprole has been grouped
with the diamide pesticide class. As
part of the ongoing process to review
registered pesticides, the Agency
intends to apply this framework to
determine if the available toxicological
data for cyantraniliprole suggests a
candidate CMG may be established with
other pesticides. If a CMG is established,
a screening-level toxicology and
exposure analysis may be conducted to
provide an initial screen for multiple
pesticide exposure.
Safety factor for infants and children.
Section 408(b)(2)(C) of FFDCA provides
that EPA shall apply an additional
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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.
EPA continues to conclude that there is
reliable data showing that the safety of
infants and children would be
adequately protected if the Food Quality
Protection Act (FQPA) safety factor were
reduced from 10X to 1X. The reasons for
that decision are articulated in Unit III.D
of the November 13, 2018, rulemaking.
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 populationadjusted dose (aPAD) and chronic PAD
(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 to
ensure that an adequate margin of
exposure (MOE) exists. An acute dietary
exposure assessment was not performed
as there were no indication of an
adverse effects attributable to a single
dose. Cyantraniliprole is not expected to
pose an acute risk.
Chronic dietary risks are below the
Agency’s level of concern of 100% of
the cPAD; they are 85% of the cPAD for
children 1 to 2 years old, the most
highly exposed population subgroup.
The chronic aggregate risk assessment
includes only long-term exposure to
residues in food and drinking water
since there are no residential scenarios
that result in long-term exposure;
therefore, the chronic aggregate risks are
equivalent to the chronic dietary risks
and are not of concern.
There is potential for short-term
aggregate exposure to cyantraniliprole
via the dietary (food + drinking water)
and residential pathways. Since there is
no dermal endpoint, the short-term
aggregate exposure assessment for
children includes dietary (considered
background) and incidental oral
(primary) routes. For children 1 to 2
years old, the short-term aggregate risk
estimates are not of concern. The
aggregate MOE is 159, which is greater
than the level of concern of 100.
Intermediate-term aggregate
assessments include exposures that will
occur from 30 days to 6 months.
Residential intermediate-term exposures
are not expected for adults, however
intermediate-term incidental oral postapplication exposures for children 1 to
<2 years old are possible (i.e., from
contact to treated carpet), due to the
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persistence of cyantraniliprole. Since
the incidental oral POD is the same for
short-term and intermediate-term
durations, the short-term aggregate risk
estimates are protective of potential
intermediate aggregate risks and are not
of concern.
Based on the lack of evidence of
carcinogenicity in two adequate rodent
carcinogenicity studies, cyantraniliprole
is not expected to pose a cancer risk to
humans.
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
cyantraniliprole residues. More detailed
information on this action can be found
in the document titled
‘‘Cyantraniliprole: New Uses of
Cyantraniliprole on Herb Group 25,
Hops, Papaya and Spice Group 26;
Amended Application Scenario for
Lettuce (Greenhouse Application) and
Strawberry (Reduction in Retreatment
Interval); Crop Subgroup Expansions to
Field Corn Subgroup 15–22C, Sweet
Corn Subgroup 15–22D and Rice
Subgroup 15–22F; and Crop Subgroup
Conversion to Legume Vegetable
Subgroup 6–22A–F and 7–22A.’’ in
docket ID EPA–HQ–OPP–2023–0078,
and the document titled
‘‘Cyantraniliprole. Human Health Risk
Assessment for the Proposed Section 3
Tolerance Request without U.S.
Registration for Grape (table), Avocado,
Mango, and Olive to Replace Existing
Import Tolerances on Olive and Olive,
Oil’’ in docket ID EPA–HQ–OPP–2022–
0958. The rule is establishing tolerances
from two separate petitions and
summarizes information from both risk
assessments. The dietary exposure
estimates and MOE numbers referenced
above are from the more recently
conducted, comprehensive assessment
titled ‘‘Cyantraniliprole. Human Health
Risk Assessment for the Proposed
Section 3 Tolerance Request without
U.S. Registration for Grape (table),
Avocado, Mango, and Olive to Replace
Existing Import Tolerances on Olive and
Olive, Oil’’, which includes the
additional exposures described in the
other risk assessment.
IV. Other Considerations
A. Analytical Enforcement Methodology
For information about the available
analytical enforcement method, see Unit
IV.A of the November 13, 2018,
rulemaking.
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B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex does not have MRLs for
residues of cyantraniliprole in/on herbs
(fresh or dried), spices, hops, papaya, or
the foliage of legume vegetables. The
U.S. tolerances for residues of
cyantraniliprole in or on subgroups 6–
22A (2 ppm), 6–22B (2 ppm), 6–22C (0.3
ppm), 6–22D (0.3 ppm), avocados (0.4
ppm), and grapes, table (2 ppm) and
mango (0.7 ppm) are harmonized with
the corresponding Codex MRLs. The
U.S. tolerances for residues of
cyantraniliprole in or on subgroups 6–
22E (1 ppm) and 6–22F (1 ppm) cannot
be not harmonized with the Codex MRL
of 0.3 ppm because decreasing the
tolerance to harmonize would put U.S.
growers at risk of having violative
residues despite legal use of
cyantraniliprole according to the label.
The U.S. tolerance for residues of
cyantraniliprole on olives (3 ppm)
cannot be harmonized with the Codex
MRL of 1 ppm because imported olives
treated legally in the exporting country
could have violative residues.
C. Response to Comments
There were no comments received on
the notice of filing of pesticide petition
PP2E9041 submitted by IR–4. One
comment was received on the notice of
filing of pesticide petition PP2E9032
submitted by the FMC Corporation. The
comment is an inquiry from the People’s
Republic of China, requesting that the
Agency provide the test data used for
risk assessment of the relevant
commodities. The data supporting the
avocado, grape, mango, and olive
tolerances were submitted to the Agency
and were reviewed and reported in the
document titled ‘‘Cyantraniliprole.
Human Health Risk Assessment for the
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Proposed Section 3 Tolerance Request
without U.S. Registration for Grape
(table), Avocado, Mango, and Olive to
Replace Existing Import Tolerances on
Olive and Olive, Oil.’’ This document
can be found in docket ID number EPA–
HQ–OPP–2022–0958.
D. Revisions to Petitioned-For
Tolerances
The Agency is revising the
commodity definitions for many of the
tolerances to current agency
nomenclature.
EPA is also not establishing the
requested tolerances of cyantraniliprole
in/on the field corn subgroup 15–22C,
sweet corn subgroup 15–22D and rice
subgroup 15–22F because the petitioner
withdrew the requested tolerances from
the petition.
EPA is establishing the tolerance for
residues of cyantraniliprole in or on
grape, table at 2 ppm rather than 2.0
ppm and the tolerance for olive at 3
ppm rather than 3.0 ppm to be
consistent with EPA rounding practices.
V. Conclusion
Therefore, tolerances are established
for residues of cyantraniliprole,
including its metabolites and
degradates, in or on the following
commodities: herb, dried leaves,
subgroup 25B at 150 ppm; herb, fresh
leaves, subgroup 25A at 40 ppm; hop,
dried cones at 70 ppm; papaya at 1.5
ppm; spice crop group 26 at 80 ppm;
vegetable, legume, bean, edible podded,
subgroup 6–22A at 2 ppm; vegetable,
legume, bean, succulent shelled,
subgroup 6–22C at 0.3 ppm; vegetable,
legume, forage and hay, except soybean,
subgroup 7–22A at 40 ppm; vegetable,
legume, pea, edible podded, subgroup
6–22B at 2 ppm; vegetable, legume, pea,
succulent shelled, subgroup 6–22D at
0.3 ppm; vegetable, legume, pulse, bean,
dried shelled, except soybean, subgroup
6–22E at 1 ppm; and vegetable, legume,
pulse, pea, dried shelled, subgroup 6–
22F at 1 ppm. EPA is removing the
established tolerances for residues of
cyantraniliprole, in or on the following
commodities upon the establishment of
the new tolerances: vegetable, foliage of
legume, except soybean, group 7A at 40
ppm; vegetable, legume, dried shelled,
except soybean, subgroup 6C at 1.0
ppm; vegetable, legume, edible podded,
subgroup 6A at 2.0 ppm; and vegetable,
legume, succulent shelled, subgroup 6B
at 0.20 ppm.
Additionally, tolerances are
established for residues of
cyantraniliprole, including its
metabolites and degradates, in or on the
following imported commodities:
avocado at 0.4 ppm; grape, table at 2
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Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations
ppm; and mango at 0.7 ppm. Finally,
the tolerance for residues of
cyantraniliprole, including its
metabolites and degradates, in or on
olive is revised from 1.5 ppm to 3 ppm
and the tolerance for residues in or on
olive, oil at 2.0 ppm is removed.
VI. Statutory and Executive Order
Reviews
lotter on DSK11XQN23PROD with RULES1
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
VerDate Sep<11>2014
15:57 May 14, 2024
Jkt 262001
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 9, 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:
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
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 § 180.672, amend the table in
paragraph (a) by:
■ a. Adding the table heading ‘‘Table 1
to Paragraph (a)’’;
■ b. Adding in alphabetical order the
entries ‘‘Avocado2’’; ‘‘Grape, table2’’;
‘‘Herb, dried leaves, subgroup 25B’’;
‘‘Herb, fresh leaves, subgroup 25A’’;
‘‘Hop, dried cones’’; and ‘‘Mango 2’’;
■ c. Revising the entry for ‘‘Olive1’’;
■ d. Removing the entry for ‘‘Olive,
oil1’’;
■ e. Adding in alphabetical order the
entries ‘‘Papaya’’; and ‘‘Spice crop
group 26’’;
■ f. Removing the entry for ‘‘Vegetable,
foliage of legume, except soybean, group
7A’’;
■ g. Adding in alphabetical order the
entries ‘‘Vegetable, legume, bean, edible
podded, subgroup 6–22A’’; and
‘‘Vegetable, legume, bean, succulent
shelled, subgroup 6–22C’’;
■ h. Removing the entries for
‘‘Vegetable, legume, dried shelled,
except soybean, subgroup 6C’’; and
‘‘Vegetable, legume, edible podded,
subgroup 6A’’;
■ i. Adding in alphabetical order the
entries ‘‘Vegetable, legume, forage and
hay, except soybean, subgroup 7–22A’’;
‘‘Vegetable, legume, pea, edible podded,
subgroup 6–22B’’; ‘‘Vegetable, legume,
pea, succulent shelled, subgroup 6–
22D’’; ‘‘Vegetable, legume, pulse, bean,
dried shelled, except soybean, subgroup
6–22E’’; and ‘‘Vegetable, legume, pulse,
pea, dried shelled, subgroup 6–22F’’;
and
■ j. Removing the entry for ‘‘Vegetable,
legume, succulent shelled, subgroup
6B’’.
The additions and revision read as
follows:
■
§ 180.672 Cyantraniliprole; tolerance for
residues.
(a) * * *
E:\FR\FM\15MYR1.SGM
15MYR1
Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations
TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
*
*
*
*
*
*
*
0.4
*
Grape, table 2 ..............................
*
*
*
*
*
Herb, dried leaves, subgroup
25B ..........................................
Herb, fresh leaves, subgroup
25A ..........................................
Hop, dried cones ........................
*
*
*
*
*
Mango 2 .......................................
*
*
*
*
*
Olive 2 ..........................................
*
*
*
*
Papaya ........................................
*
*
*
*
*
Spice crop group 26 ...................
*
*
*
*
*
Vegetable, legume, bean, edible
podded, subgroup 6–22A .......
Vegetable, legume, bean, succulent shelled, subgroup 6–
22C ..........................................
Vegetable, legume, forage and
hay, except soybean, subgroup 7–22A ...........................
Vegetable, legume, pea, edible
podded, subgroup 6–22B .......
Vegetable, legume, pea, succulent shelled, subgroup 6–
22D ..........................................
Vegetable, legume, pulse, bean,
dried shelled, except soybean,
subgroup 6–22E ......................
Vegetable, legume, pulse, pea,
dried shelled, subgroup 6–22F
lotter on DSK11XQN23PROD with RULES1
*
*
*
*
Environmental Protection
Agency (EPA).
2 ACTION: Final rule.
This regulation establishes
tolerance for residues of tetraniliprole in
or on tea, dried at 80 ppm. Bayer
150 CropScience LP requested this tolerance
under the Federal Food, Drug, and
40 Cosmetic Act (FFDCA).
70 DATES: This regulation is effective May
15, 2024. Objections and requests for
hearings must be received on or before
July 15, 2024 and must be filed in
0.7 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–2021–0624, is
1.5 available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
80 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.,
2 Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room and the OPP
0.3
Docket is (202) 566–1744. Please review
the visitor instructions and additional
40 information about the docket available
at https://www.epa.gov/dockets.
2 FOR FURTHER INFORMATION CONTACT:
Charles Smith, Director, Registration
Division (7505T), Office of Pesticide
0.3 Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
1
telephone number: (202) 566–1030;
1 email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
*
*
*
*
*
[FR Doc. 2024–10490 Filed 5–14–24; 8:45 am]
BILLING CODE 6560–50–P
VerDate Sep<11>2014
15:57 May 14, 2024
Jkt 262001
ADDRESSES:
I. General Information
1 There are no U.S. registrations for these
commodities.
2 There are no U.S. registrations for these
commodities as of May 15, 2024.
*
Tetraniliprole; Pesticide Tolerances
AGENCY:
3
*
40 CFR Part 180
[EPA–HQ–OPP–2021–0624; FRL–11958–01–
OCSPP]
*
Avocado 2 ....................................
*
ENVIRONMENTAL PROTECTION
AGENCY
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
PO 00000
Frm 00047
Fmt 4700
Sfmt 4700
42387
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/
current/title-40.
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–2021–0624 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
15, 2024. Addresses for mail and hand
delivery of objections and hearing
requests are provided in 40 CFR
178.25(b).
EPA’s Office of Administrative Law
Judges (OALJ), in which the Hearing
Clerk is housed, urges parties to file and
serve documents by electronic means
only, notwithstanding any other
particular requirements set forth in
other procedural rules governing those
proceedings. See ‘‘Revised Order Urging
Electronic Service and Filing’’, dated
June 22, 2023, which can be found at
https://www.epa.gov/system/files/
documents/2023-06/2023-06-22%20%20revised%20order%20urging
%20electronic%20filing%20and
%20service.pdf.
Although EPA’s regulations require
submission via U.S. Mail or hand
delivery, EPA intends to treat
submissions filed via electronic means
as properly filed submissions; therefore,
EPA believes the preference for
submission via electronic means will
not be prejudicial. When submitting
documents to the OALJ electronically, a
person should utilize the OALJ e-filing
system at https://yosemite.epa.gov/oa/
eab/eab-alj_upload.nsf.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
E:\FR\FM\15MYR1.SGM
15MYR1
Agencies
[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)]
[Rules and Regulations]
[Pages 42382-42387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10490]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0078 and EPA-HQ-OPP-2022-0958; FRL-11941-01-OCSPP]
Cyantraniliprole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes and modifies tolerances for
residues of cyantraniliprole, including its metabolites and degradates,
in or on multiple commodities which are identified and discussed later
in this document. The Interregional Project Number 4 (IR-4) and the FMC
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 15, 2024. Objections and
requests for hearings must be received on or before July 15, 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) numbers EPA-HQ-OPP-2023-0078 and EPA-HQ-OPP-2022-
0958, is available online at https://www.regulations.gov or in-person
at the Office of Pesticide Programs Regulatory Public Docket (OPP
Docket) in the Environmental Protection Agency Docket Center (EPA/DC),
West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave.
NW, Washington, DC 20460-0001. The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room and the OPP
Docket is (202) 566-1744. For the latest status information on EPA/DC
services, docket access, visit 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/current/title-40.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2023-0078 and EPA-HQ-OPP-2022-0958 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 15, 2024. Addresses for mail and hand
delivery of objections and hearing requests are provided in 40 CFR
178.25(b).
EPA's Office of Administrative Law Judges (OALJ), in which the
Hearing Clerk is housed, urges parties to file and serve documents by
electronic means only, notwithstanding any other particular
requirements set forth in other procedural rules governing those
proceedings. See ``Revised Order Urging Electronic Service and
Filing'', dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf.
Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions; therefore, EPA believes the preference
for submission via electronic means will not be prejudicial. When
submitting documents to the OALJ electronically, a person should
utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm.
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
[[Page 42383]]
objection or hearing request, identified by docket ID number EPA-HQ-
OPP-2023-0078 and EPA-HQ-OPP-2022-0958, 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.
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 July 26, 2023 (88 FR 48179) (FRL-10579-
06-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition
(PP2E9041) 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 requested to amend 40 CFR 180.672 by
establishing tolerances for residues of cyantraniliprole, including its
metabolites and degradates, in or on the following commodities: edible
podded bean subgroup 6-22A at 2 parts per million (ppm); edible podded
pea subgroup 6-22B at 2 ppm; field corn subgroup 15-22C at 0.01 ppm;
forage and hay of legume vegetables (except soybeans) subgroup 7-22A at
40 ppm; herb fresh leaves subgroup 25A at 40 ppm; herb dried leaves
subgroup 25B at 150 ppm; hops, dried cones at 70 ppm; papaya at 1.5
ppm; pulses, dried shelled bean, except soybean, subgroup 6-22E at 1
ppm; pulses, dried shelled pea subgroup 6-22F at 1 ppm; rice subgroup
15-22F at 0.02 ppm; spices crop group 26 at 80 ppm; succulent shelled
bean subgroup 6-22C at 0.3 ppm; succulent shelled pea subgroup 6-22D at
0.3 ppm; and sweet corn subgroup 15-22D at 0.01 ppm. The petitioner
proposed, upon the approval of the aforementioned tolerances, to remove
established tolerances for residues of cyantraniliprole, including its
metabolites and degradates, in or on the following commodities:
vegetable, legume, dried shelled, except soybean, subgroup 6C at 1.0
ppm; vegetable, legume, edible podded, subgroup 6A at 2.0 ppm;
vegetable, legume, succulent shelled, subgroup 6B at 0.20 ppm;
vegetable, foliage of legume, except soybean, group 7A at 40 ppm; corn,
field, grain at 0.01 ppm; corn, pop, grain, at 0.01 ppm; corn, sweet,
kernel plus cob with husks removed at 0.01 ppm; and rice, grain at 0.02
ppm. That document referenced a summary of the petition prepared by IR-
4, the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received on the notice of
filing.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
has made modifications to the proposed commodity definitions for most
of the tolerances in this petition and is not establishing several of
the petitioned-for tolerances because the petitioner withdrew them. The
reasons for these changes are explained in Unit IV.D.
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 a pesticide
petition (PP2E9032) by the FMC Corporation, 2929 Walnut Street,
Philadelphia, PA 19104, requesting, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180 by establishing tolerances for residues of
cyantraniliprole, including its metabolites and degradates in or on the
following commodities: grape, table at 2.0 ppm (only for imported table
grapes); avocado at 0.4 ppm (only for imported avocados); and mango at
0.7 ppm (only for imported mangos) and by revising the tolerance for
imported olives from 1.5 ppm to 3.0 ppm and, upon the approval of the
aforementioned tolerances, to remove established tolerances for
residues of cyantraniliprole, including its metabolites and degradates,
in or on olive oil at 2 ppm. That document referenced a summary of the
petition prepared by FMC, the petitioner, which is available in the
docket, https://www.regulations.gov. A comment was received on the
notice of filing. EPA's response to the comment is discussed in Unit
IV.C.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
has made modifications to two of the proposed tolerance values. The
reason for these changes is explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
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 cyantraniliprole including exposure resulting
from the tolerances established by this action. EPA's assessment of
exposures and risks associated with cyantraniliprole 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
cyantraniliprole in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to cyantraniliprole 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.
[[Page 42384]]
Toxicological profile. For a discussion of the Toxicological
Profile of cyantraniliprole, see Unit III.A. of the cyantraniliprole
tolerance rulemaking published in the Federal Register of November 13,
2018 (83 FR 56262) (FRL-9985-32).
Toxicological points of departure/Levels of concern. For a
discussion of the Toxicological Points of Departure/Levels of Concern
used for the safety assessment of cyantraniliprole, see Unit III.B of
the February 5, 2014, rulemaking (79 FR 6826) (FRL-9388-7).
Dietary exposure assessment. Much of the exposure assessment for
cyantraniliprole remains unchanged from the discussion in Unit III.C of
the November 13, 2018, rulemaking, except as described below. EPA's
dietary exposure assessments have been updated to include the
additional exposures from the tolerances established since the November
13, 2018, rulemaking and the petitioned-for tolerances excluding the
crop subgroup expansions to field corn subgroup 15-22C, sweet corn
subgroup 15-22D and rice subgroup 15-22F. An acute dietary endpoint was
not selected; therefore, an acute assessment was not performed. A
refined chronic dietary (food and drinking water) exposure assessment
was conducted using the Dietary Exposure Evaluation Model-Food
Commodity Intake Database DEEM-FCID and assuming average field trial
residues or mean residue values from the United States Department of
Agriculture (USDA) Pesticide Data Program (PDP), empirical processing
factors and/or HED's default processing factors and assumed 100 percent
crop treated (PCT). In some cases, data were translated from
representative commodities of their crop group.
Anticipated residue information. Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and information on the anticipated
residue levels of pesticide residues in food and the actual levels of
pesticide residues that have been measured in food. If EPA relies on
such information, EPA must require pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. For the present action, EPA will
issue such data call-ins as are required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section 408(f)(1). Data will be required to
be submitted no later than 5 years from the date of issuance of these
tolerances.
Drinking water and non-occupational exposures. The estimated
drinking water concentrations (EDWCs) have not changed since the 2018
rulemaking. For a detailed summary of the drinking water analysis for
cyantraniliprole used for the human health risk assessment, see Unit
III.C.2. of the November 13, 2018, tolerance rulemaking. There are no
proposed residential uses or proposed uses intended for use by
occupational handlers in residential settings for this action. However,
there are residential exposures from currently registered uses of
cyantraniliprole which have been previously assessed. The registered
residential uses and exposures that are incorporated into the aggregate
assessment are described in Unit III.C.3 of the November 13, 2018,
final rule.
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
cyantraniliprole and any other substances and cyantraniliprole does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has not assumed
that cyantraniliprole has a common mechanism of toxicity with other
substances.
In 2016, EPA's Office of Pesticide Programs released a guidance
document entitled, Pesticide Cumulative Risk Assessment: Framework for
Screening Analysis https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. This
document provides guidance on how to screen groups of pesticides for
cumulative evaluation using a two-step approach beginning with the
evaluation of available toxicological information and if necessary,
followed by a risk-based screening approach. This framework supplements
the existing guidance documents for establishing common mechanism
groups (CMG) and conducting cumulative risk assessments.
Cyantraniliprole has been grouped with the diamide pesticide class.
As part of the ongoing process to review registered pesticides, the
Agency intends to apply this framework to determine if the available
toxicological data for cyantraniliprole suggests a candidate CMG may be
established with other pesticides. If a CMG is established, a
screening-level toxicology and exposure analysis may be conducted to
provide an initial screen for multiple pesticide exposure.
Safety factor for infants and children. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply an additional tenfold (10X) margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
database on toxicity and exposure unless EPA determines based on
reliable data that a different margin of safety will be safe for
infants and children. EPA continues to conclude that there is reliable
data showing that the safety of infants and children would be
adequately protected if the Food Quality Protection Act (FQPA) safety
factor were reduced from 10X to 1X. The reasons for that decision are
articulated in Unit III.D of the November 13, 2018, rulemaking.
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 PAD (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 to ensure
that an adequate margin of exposure (MOE) exists. An acute dietary
exposure assessment was not performed as there were no indication of an
adverse effects attributable to a single dose. Cyantraniliprole is not
expected to pose an acute risk.
Chronic dietary risks are below the Agency's level of concern of
100% of the cPAD; they are 85% of the cPAD for children 1 to 2 years
old, the most highly exposed population subgroup. The chronic aggregate
risk assessment includes only long-term exposure to residues in food
and drinking water since there are no residential scenarios that result
in long-term exposure; therefore, the chronic aggregate risks are
equivalent to the chronic dietary risks and are not of concern.
There is potential for short-term aggregate exposure to
cyantraniliprole via the dietary (food + drinking water) and
residential pathways. Since there is no dermal endpoint, the short-term
aggregate exposure assessment for children includes dietary (considered
background) and incidental oral (primary) routes. For children 1 to 2
years old, the short-term aggregate risk estimates are not of concern.
The aggregate MOE is 159, which is greater than the level of concern of
100.
Intermediate-term aggregate assessments include exposures that will
occur from 30 days to 6 months. Residential intermediate-term exposures
are not expected for adults, however intermediate-term incidental oral
post-application exposures for children 1 to <2 years old are possible
(i.e., from contact to treated carpet), due to the
[[Page 42385]]
persistence of cyantraniliprole. Since the incidental oral POD is the
same for short-term and intermediate-term durations, the short-term
aggregate risk estimates are protective of potential intermediate
aggregate risks and are not of concern.
Based on the lack of evidence of carcinogenicity in two adequate
rodent carcinogenicity studies, cyantraniliprole is not expected to
pose a cancer risk to humans.
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 cyantraniliprole residues. More detailed information on
this action can be found in the document titled ``Cyantraniliprole: New
Uses of Cyantraniliprole on Herb Group 25, Hops, Papaya and Spice Group
26; Amended Application Scenario for Lettuce (Greenhouse Application)
and Strawberry (Reduction in Retreatment Interval); Crop Subgroup
Expansions to Field Corn Subgroup 15-22C, Sweet Corn Subgroup 15-22D
and Rice Subgroup 15-22F; and Crop Subgroup Conversion to Legume
Vegetable Subgroup 6-22A-F and 7-22A.'' in docket ID EPA-HQ-OPP-2023-
0078, and the document titled ``Cyantraniliprole. Human Health Risk
Assessment for the Proposed Section 3 Tolerance Request without U.S.
Registration for Grape (table), Avocado, Mango, and Olive to Replace
Existing Import Tolerances on Olive and Olive, Oil'' in docket ID EPA-
HQ-OPP-2022-0958. The rule is establishing tolerances from two separate
petitions and summarizes information from both risk assessments. The
dietary exposure estimates and MOE numbers referenced above are from
the more recently conducted, comprehensive assessment titled
``Cyantraniliprole. Human Health Risk Assessment for the Proposed
Section 3 Tolerance Request without U.S. Registration for Grape
(table), Avocado, Mango, and Olive to Replace Existing Import
Tolerances on Olive and Olive, Oil'', which includes the additional
exposures described in the other risk assessment.
IV. Other Considerations
A. Analytical Enforcement Methodology
For information about the available analytical enforcement method,
see Unit IV.A of the November 13, 2018, rulemaking.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex does not have MRLs for residues of cyantraniliprole in/on
herbs (fresh or dried), spices, hops, papaya, or the foliage of legume
vegetables. The U.S. tolerances for residues of cyantraniliprole in or
on subgroups 6-22A (2 ppm), 6-22B (2 ppm), 6-22C (0.3 ppm), 6-22D (0.3
ppm), avocados (0.4 ppm), and grapes, table (2 ppm) and mango (0.7 ppm)
are harmonized with the corresponding Codex MRLs. The U.S. tolerances
for residues of cyantraniliprole in or on subgroups 6-22E (1 ppm) and
6-22F (1 ppm) cannot be not harmonized with the Codex MRL of 0.3 ppm
because decreasing the tolerance to harmonize would put U.S. growers at
risk of having violative residues despite legal use of cyantraniliprole
according to the label. The U.S. tolerance for residues of
cyantraniliprole on olives (3 ppm) cannot be harmonized with the Codex
MRL of 1 ppm because imported olives treated legally in the exporting
country could have violative residues.
C. Response to Comments
There were no comments received on the notice of filing of
pesticide petition PP2E9041 submitted by IR-4. One comment was received
on the notice of filing of pesticide petition PP2E9032 submitted by the
FMC Corporation. The comment is an inquiry from the People's Republic
of China, requesting that the Agency provide the test data used for
risk assessment of the relevant commodities. The data supporting the
avocado, grape, mango, and olive tolerances were submitted to the
Agency and were reviewed and reported in the document titled
``Cyantraniliprole. Human Health Risk Assessment for the Proposed
Section 3 Tolerance Request without U.S. Registration for Grape
(table), Avocado, Mango, and Olive to Replace Existing Import
Tolerances on Olive and Olive, Oil.'' This document can be found in
docket ID number EPA-HQ-OPP-2022-0958.
D. Revisions to Petitioned-For Tolerances
The Agency is revising the commodity definitions for many of the
tolerances to current agency nomenclature.
EPA is also not establishing the requested tolerances of
cyantraniliprole in/on the field corn subgroup 15-22C, sweet corn
subgroup 15-22D and rice subgroup 15-22F because the petitioner
withdrew the requested tolerances from the petition.
EPA is establishing the tolerance for residues of cyantraniliprole
in or on grape, table at 2 ppm rather than 2.0 ppm and the tolerance
for olive at 3 ppm rather than 3.0 ppm to be consistent with EPA
rounding practices.
V. Conclusion
Therefore, tolerances are established for residues of
cyantraniliprole, including its metabolites and degradates, in or on
the following commodities: herb, dried leaves, subgroup 25B at 150 ppm;
herb, fresh leaves, subgroup 25A at 40 ppm; hop, dried cones at 70 ppm;
papaya at 1.5 ppm; spice crop group 26 at 80 ppm; vegetable, legume,
bean, edible podded, subgroup 6-22A at 2 ppm; vegetable, legume, bean,
succulent shelled, subgroup 6-22C at 0.3 ppm; vegetable, legume, forage
and hay, except soybean, subgroup 7-22A at 40 ppm; vegetable, legume,
pea, edible podded, subgroup 6-22B at 2 ppm; vegetable, legume, pea,
succulent shelled, subgroup 6-22D at 0.3 ppm; vegetable, legume, pulse,
bean, dried shelled, except soybean, subgroup 6-22E at 1 ppm; and
vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F at 1 ppm.
EPA is removing the established tolerances for residues of
cyantraniliprole, in or on the following commodities upon the
establishment of the new tolerances: vegetable, foliage of legume,
except soybean, group 7A at 40 ppm; vegetable, legume, dried shelled,
except soybean, subgroup 6C at 1.0 ppm; vegetable, legume, edible
podded, subgroup 6A at 2.0 ppm; and vegetable, legume, succulent
shelled, subgroup 6B at 0.20 ppm.
Additionally, tolerances are established for residues of
cyantraniliprole, including its metabolites and degradates, in or on
the following imported commodities: avocado at 0.4 ppm; grape, table at
2
[[Page 42386]]
ppm; and mango at 0.7 ppm. Finally, the tolerance for residues of
cyantraniliprole, including its metabolites and degradates, in or on
olive is revised from 1.5 ppm to 3 ppm and the tolerance for residues
in or on olive, oil at 2.0 ppm is removed.
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 9, 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. 180.672, amend the table in paragraph (a) by:
0
a. Adding the table heading ``Table 1 to Paragraph (a)'';
0
b. Adding in alphabetical order the entries ``Avocado\2\''; ``Grape,
table\2\''; ``Herb, dried leaves, subgroup 25B''; ``Herb, fresh leaves,
subgroup 25A''; ``Hop, dried cones''; and ``Mango \2\'';
0
c. Revising the entry for ``Olive\1\'';
0
d. Removing the entry for ``Olive, oil\1\'';
0
e. Adding in alphabetical order the entries ``Papaya''; and ``Spice
crop group 26'';
0
f. Removing the entry for ``Vegetable, foliage of legume, except
soybean, group 7A'';
0
g. Adding in alphabetical order the entries ``Vegetable, legume, bean,
edible podded, subgroup 6-22A''; and ``Vegetable, legume, bean,
succulent shelled, subgroup 6-22C'';
0
h. Removing the entries for ``Vegetable, legume, dried shelled, except
soybean, subgroup 6C''; and ``Vegetable, legume, edible podded,
subgroup 6A'';
0
i. Adding in alphabetical order the entries ``Vegetable, legume, forage
and hay, except soybean, subgroup 7-22A''; ``Vegetable, legume, pea,
edible podded, subgroup 6-22B''; ``Vegetable, legume, pea, succulent
shelled, subgroup 6-22D''; ``Vegetable, legume, pulse, bean, dried
shelled, except soybean, subgroup 6-22E''; and ``Vegetable, legume,
pulse, pea, dried shelled, subgroup 6-22F''; and
0
j. Removing the entry for ``Vegetable, legume, succulent shelled,
subgroup 6B''.
The additions and revision read as follows:
Sec. 180.672 Cyantraniliprole; tolerance for residues.
(a) * * *
[[Page 42387]]
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Avocado \2\................................................. 0.4
* * * * *
Grape, table \2\............................................ 2
* * * * *
Herb, dried leaves, subgroup 25B............................ 150
Herb, fresh leaves, subgroup 25A............................ 40
Hop, dried cones............................................ 70
* * * * *
Mango \2\................................................... 0.7
* * * * *
Olive \2\................................................... 3
* * * * *
Papaya...................................................... 1.5
* * * * *
Spice crop group 26......................................... 80
* * * * *
Vegetable, legume, bean, edible podded, subgroup 6-22A...... 2
Vegetable, legume, bean, succulent shelled, subgroup 6-22C.. 0.3
Vegetable, legume, forage and hay, except soybean, subgroup 40
7-22A......................................................
Vegetable, legume, pea, edible podded, subgroup 6-22B....... 2
Vegetable, legume, pea, succulent shelled, subgroup 6-22D... 0.3
Vegetable, legume, pulse, bean, dried shelled, except 1
soybean, subgroup 6-22E....................................
Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F 1
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for these commodities.
\2\ There are no U.S. registrations for these commodities as of May 15,
2024.
* * * * *
[FR Doc. 2024-10490 Filed 5-14-24; 8:45 am]
BILLING CODE 6560-50-P