Rule2023-13023
Trifloxystrobin; Pesticide Tolerances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 20, 2023
Effective
June 20, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of trifloxystrobin in or on multiple crops that are discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 88 Issue 117 (Tuesday, June 20, 2023)</title>
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[Federal Register Volume 88, Number 117 (Tuesday, June 20, 2023)]
[Rules and Regulations]
[Pages 39770-39776]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13023]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0448; FRL-10570-01-OCSPP]
Trifloxystrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
trifloxystrobin in or on multiple crops that are discussed later in
this document. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective June 20, 2023. Objections and
requests for hearings must be received on or before August 21, 2023,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0448, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#e7b5a3a1b5a988938e848294a7829786c9808891"><span class="__cf_email__" data-cfemail="20726466726e4f5449434553604550410e474f56">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at <a href="https://www.ecfr.gov/current/title">https://www.ecfr.gov/current/title</a>.
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-2021-0448 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
August 21, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b), although the Office
of the Administrative Law Judges, which houses the Hearing Clerk,
encourages parties to file objections and hearing requests
electronically. See <a href="https://www.epa.gov////-05//2020-04-10_-_order_urging_electronic_service_and_filing.pdf">https://www.epa.gov////-05//2020-04-10_-_order_urging_electronic_service_and_filing.pdf</a>.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information
[[Page 39771]]
(CBI)) for inclusion in the public docket. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit the non-CBI copy of your objection or
hearing request, identified by docket ID number EPA-HQ-OPP-2021-0448,
by one of the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov//where-send-comments-epa-dockets">https://www.epa.gov//where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of October 21, 2021 (86 FR 58239) (FRL-
8792-04-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 1E8931) by IR-4, North Carolina State University, 1730
Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition
requested that 40 CFR 180.555 be amended by establishing tolerances for
residues of trifloxystrobin, methyl ([alpha]E)-[alpha]-(methoxyimino)-
2-[[[[(1E)-1-[3-(trifluoromethyl)phenyl]
ethylidene]amino]oxy]methyl]benzeneace, in or on the raw agricultural
commodities Brassica, leafy greens, subgroup 4-16B at 30 parts per
million (ppm); Celtuce at 9 ppm; Fennel, Florence, fresh leaves and
stalk at 9 ppm; Fruit, citrus, group 10-10 at 0.6 ppm; Fruit, pome,
group 11-10 at 0.7 ppm; Fruit, stone, group 12-12 at 3 ppm; Kohlrabi at
2 ppm; Leafy greens subgroup 4-16A at 30 ppm; Leaf petiole vegetable
subgroup 22B at 9 ppm; Nut, tree, group 14-12 at 0.04 ppm; Onion, bulb,
subgroup 3-07A at 0.04 ppm; Onion, green, subgroup 3-07B at 1.5 ppm;
Spice group 26 at 30 ppm; Vegetable, Brassica, head and stem, group 5-
16 at 2 ppm; Vegetable, fruiting, group 8-10 at 0.5 ppm; Individual
crops of Proposed Subgroup 6-XXA: Edible podded bean legume vegetable
subgroup at 1.5 ppm; Individual crops of Proposed Subgroup 6-XXE: Dried
shelled bean, except soybean, subgroup at 0.06 ppm; and Individual
commodities of Proposed Crop Subgroup 6-XXF: Dried shelled pea subgroup
at 0.2 ppm. Due to the length of the list of commodities, please refer
to the document EPA issued in the Federal Register on October 21, 2021,
for a complete list of the tolerances requested.
The petition also proposed to remove established tolerances for
residues of trifloxystrobin in or on the following: Brassica, head and
stem, subgroup 5A at 2.0 ppm; Brassica, leafy greens, subgroup 5B at 30
ppm; Fruit, citrus, group 10 at 0.6 ppm; Fruit, pome at 0.5 ppm; Fruit,
stone, group 12 at 2 ppm; Leaf petioles subgroup 4B at 9.0 ppm; Leafy
greens, subgroup 4A at 30 ppm; Nut, tree, group 14 at 0.04 ppm; Pea and
bean, dried shelled, except soybean, subgroup 6C at 0.06 ppm; Pistachio
at 0.04 ppm; Vegetable, fruiting at 0.5 ppm.
That document referenced a summary of the petition, which is
available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. No substantive
comments were submitted in response to this petition.
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 tolerances for three subgroups in the recently revised
Legume vegetable crop group 6-22 instead of the specific commodities in
those subgroups as requested by the petitioner. See the Federal
Register of September 21, 2022 (87 FR 57627) (FRL-5031-13-OCSPP).
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 trifloxystrobin including exposure resulting
from the tolerances established by this action. EPA's assessment of
exposures and risks associated with trifloxystrobin 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 rulemaking of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking, 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 a number of tolerance rulemakings for
trifloxystrobin, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to trifloxystrobin and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections of those rulemakings that remain
unchanged, as described further in this rulemaking. Specific
information on the risk assessment conducted in support of this action,
including on the studies received and the nature of the adverse effects
caused by trifloxystrobin, can be found in the document titled
``Trifloxystrobin. Human Health Risk Assessment for Proposed New Uses
on Bulb Onion (Subgroup 3-07A), Green Onion (Subgroup 3-07B), and
Individual Commodities of Proposed Subgroup 6-XXA, E, and F, and for
Crop Group Conversions and Expansions'' which is available in the
docket for this action at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Toxicological profile. For a discussion of the Toxicological
Profile of trifloxystrobin, see Unit III.A. of the trifloxystrobin
tolerance rulemaking published in the Federal Register of February 15,
2019 (84 FR 4340) (FRL-9985-23).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern used for the
safety
[[Page 39772]]
assessment, see Unit III.B. of the February 15, 2019, rulemaking.
Exposure assessment. Much of the exposure assessment remains the
same since the February 15, 2019, and January 11, 2022 (87 FR 1363)
(FRL-9086-01-OCSPP) rulemakings, although the new exposure assessment
incorporates additional dietary exposures from the petitioned-for
tolerances. These updates are discussed in this section; for a
description of the rest of EPA's approach to and assumptions for the
exposure assessment, see Unit III.C in the February 15, 2019, and Unit
III in the January 11, 2022, rulemaking.
EPA's acute and chronic dietary (food and drinking water) exposure
assessments have been updated to include the exposure from residues of
trifloxystrobin on the commodities identified in this action as well as
exposure from existing tolerances. The dietary exposure and risk
assessment 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). The acute
dietary assessment used tolerance-level residues, 100 percent crop
treated (PCT) and default processing factors. A partially refined
chronic dietary exposure and risk assessment was conducted. Chronic
dietary assumptions included average field trial residues for selected
crops (subgroups 4A and 4B, subgroups 5A and 5B, crop group 26, apples,
and rice); tolerance-level residues for all other crop commodities;
empirical and default processing factors; and some PCT data.
Anticipated residue and PCT 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.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
<bullet> Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
<bullet> Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
<bullet> Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The following average percent crop treated estimates were used in
the chronic dietary risk assessment for the following crops that are
currently registered for trifloxystrobin: almonds: 20%, apples: 35%,
apricots: 15%, cabbage: <2.5%, cantaloupes: 2.5%, carrots: 2.5%,
cauliflower: <1%, celery: 25%, cherries: 45%, corn: <2.5%, cotton: <1%,
cucumbers: <2.5%, dry beans/peas: <1%, grapefruit: 35%, grapes, table:
50%; grapes, raisin: 25%, grapes, wine: 25%, hazelnuts: 70%, lemons:
<1%, lettuce: <1%, nectarines: 15%, oranges: 10%, peaches: 10%,
peanuts: 5%, pears: 15%, pecans: 15%, peppers: <2.5%, pistachios: 10%,
plums: 5%, potatoes: <1%, prunes: <1%, pumpkins: 5%, rice: 15%,
soybeans: <2.5%, squash: <2.5%, strawberries: 15%, sugar beets: 5%,
sweet corn: <1%, tangerines: 5%, tomatoes: <1%, watermelons: 5%, wheat:
<2.5%. One hundred PCT was assumed for the remaining commodities.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than 1% or less than 2.5% as the average PCT value, respectively.
In those cases, the Agency would use 1% or 2.5% as the average PCT
value, respectively. The maximum PCT figure is the highest observed
maximum value reported within the most recent 10 years of available
public and private market survey data for the existing use and rounded
up to the nearest multiple of 5%, except where the maximum PCT is less
than 2.5%, in which case, the Agency uses 2.5% as the maximum PCT.
The Agency believes that Conditions a, b, and c discussed above
have been met. With respect to Condition a, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions b and c, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
reliable information on the regional consumption of food to which
trifloxystrobin may be applied in a particular area.
Drinking water and non-occupational exposures. The estimated
drinking water concentrations (EDWCs) have been updated since the 2019
and 2022 rulemakings. The highest daily value of 436 ppb and a post-
breakthrough average of 356 ppb for trifloxystrobin total toxic
residues (TTR) in groundwater were used as residues in drinking water
for acute and chronic dietary risk analyses, respectively.
The residential exposure assessment has not changed since the 2022
rulemaking. For a summary of the residential exposure analysis for
trifloxystrobin used for the human risk assessment, please reference
Unit III of the January 11, 2022, rulemaking.
Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires
that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider ``available
[[Page 39773]]
information'' concerning the cumulative effects of a particular
pesticide's residues and ``other substances that have a common
mechanism of toxicity.'' Unlike other pesticides for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
trifloxystrobin and any other substances and trifloxystrobin does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this action, therefore, EPA has not assumed that
trifloxystrobin 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 for all
routes of exposure other than inhalation. The FQPA safety factor of 10X
has been retained for inhalation endpoints only to account for the lack
of the subchronic inhalation toxicity study for trifloxystrobin at this
time. See Unit III.D. of the February 15, 2019, rulemaking for a
discussion of the Agency's rationale for that determination.
Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
dietary exposure estimates to the acute population-adjusted dose (aPAD)
and chronic population-adjusted dose (cPAD). Short-, intermediate-, and
chronic-term aggregate 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.
Acute dietary (food and drinking water) risks are below the
Agency's level of concern of 100% of the aPAD: they are 3% of the aPAD
for females 13 to 49 years old, which is the only population subgroup
of concern. Chronic dietary (food and drinking water) risks are below
the Agency's level of concern of 100% of the cPAD: they are 79% of the
cPAD for infants less than 1 year old, which is the population subgroup
with the highest exposure estimate. The short-term aggregate risk for
the population subgroup with the highest total exposure (children 1 to
less than 2 years old) is an aggregate MOE of 124, which is above the
level of concern of 100 and not of concern. Short-term aggregate risk
calculations are protective of the intermediate-term duration of
exposure. Because trifloxystrobin is classified as ``not likely to be
carcinogenic to humans'', EPA has concluded that aggregate exposure to
trifloxystrobin is not likely to pose a cancer risk.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to trifloxystrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the February 15, 2019, 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 U.S. tolerances are harmonized with Codex MRLs for residues of
trifloxystrobin on pome fruits, and stone fruits. There are no Codex
MRLs for Brassica, leafy greens, subgroup 4-16B; celtuce; fruit,
citrus, group 10-10; Florence fennel; kohlrabi; onion, bulb, subgroup
3-07A; or spice group 26. For many of the rest of the crops covered by
this action, the majority of Codex MRLs are lower than the U.S.
tolerances (lettuce, spinach, celery, nuts, leek (which is in green
onion subgroup 3-07B), broccoli, broccoli Chinese, cauliflower,
Brussels sprouts, cabbage, cabbage savoy, edible podded beans). No
harmonization is possible for these commodities because decreasing the
tolerance to harmonize with the Codex MRL could put U.S. growers at
risk of violative residues despite legal use of trifloxystrobin. The
U.S. tolerance for the fruiting vegetables group is being established
at 0.5 ppm and is not being harmonized with the Codex MRLs for eggplant
and tomato (0.7 ppm) or bell pepper (0.3 ppm). Harmonization with the
bell pepper tolerance could lead to violative residues despite
compliance with approved label language. Moreover, EPA prefers to leave
tolerances for these commodities at 0.5 ppm, as that level harmonizes
with Canadian MRLs. The U.S. tolerances for dried beans and peas (0.06
ppm and 0.2 ppm, respectively) are not being harmonized with the Codex
MRLs for those same commodities (0.5 ppm and 1.5 ppm, respectively)
since the Codex MRLs are more than five times higher than the U.S.
tolerances. Harmonizing with the Codex MRLs would complicate the
ability to detect pesticide misuse. Moreover, the available residue
data support the lower tolerances for dried beans and peas.
V. Conclusion
Therefore, tolerances are established for residues of
trifloxystrobin in or on Brassica, leafy greens, subgroup 4-16B at 30
ppm; Celtuce at 9 ppm; Fennel, Florence, fresh leaves and stalk at 9
ppm; Fruit, citrus, group 10-10 at 0.6 ppm; Fruit, pome, group 11-10 at
0.7 ppm; Fruit, stone, group 12-12 at 3 ppm; Kohlrabi at 2 ppm; Leaf
petiole vegetable subgroup 22B at 9 ppm; Leafy greens subgroup 4-16A at
30 ppm; Nut, tree, group 14-12 at 0.04 ppm; Onion, bulb, subgroup 3-07A
at 0.04 ppm; Onion, green, subgroup 3-07B at 1.5 ppm; Spice group 26 at
30 ppm; Vegetable, Brassica, head and stem, group 5-16 at 2 ppm;
Vegetable, fruiting, group 8-10 at 0.5 ppm; Vegetable, legume, bean,
edible podded, subgroup 6-22A at 1.5 ppm; Vegetable, legume, pulse,
bean, dried shelled, except soybean, subgroup 6-22E at 0.06 ppm; and
Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F at 0.2
ppm.
Additionally, the established tolerances on Brassica, head and
stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; Dill, seed;
Fruit, citrus, group 10; Fruit, pome; Fruit, stone, group 12; Leaf
petioles subgroup 4B; Leafy greens, subgroup 4A; Nut, tree, group 14;
Pea and bean, dried shelled, except soybean, subgroup 6C; Pistachio;
and Vegetable, fruiting, are removed as unnecessary.
The tolerance for Vegetable, legume, edible podded, subgroup 6A
with footnote 4 indicating there are no U.S. registrations on this
commodity as of January 11, 2022, is removed as unnecessary. The edible
podded beans covered by the previous subgroup 6A tolerance are included
in the newly established tolerance Vegetable, legume, bean, edible
podded, subgroup 6-22A at 1.5 ppm, which supports a domestic use on
edible podded beans. Individual tolerances are established for the
edible podded peas that were covered by the previous subgroup 6A
tolerance: Pea, dwarf, edible podded; Pea, green, edible podded; Pea,
pigeon, edible podded; Pea, snap, edible podded; Pea, snow, edible
podded; and Pea, sugar snap, edible podded. Although green pea and snap
pea are not expressly identified in subgroup 6A, they are varieties
belonging to the Pisum genus, which is covered by subgroup 6A. These
edible
[[Page 39774]]
podded pea tolerances include footnote 4 indicating there are no U.S.
registrations for these commodities.
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 to 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: June 13, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA amends 40
CFR chapter 1 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. 180.555, revise the table in paragraph (a) to read as
follows:
Sec. 180.555 Trifloxystrobin; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage............................................ 0.01
Alfalfa, hay............................................... 0.01
Almond, hulls.............................................. 9.0
Apple, wet pomace.......................................... 5.0
Artichoke, globe........................................... 1.0
Asparagus.................................................. 0.07
Banana \1\................................................. 0.10
Barley, grain.............................................. 0.05
Barley, hay................................................ 0.3
Barley, straw.............................................. 5.0
Beet, sugar, dried pulp.................................... 0.4
Beet, sugar, molasses...................................... 0.2
Beet, sugar, roots......................................... 0.1
Beet, sugar, tops.......................................... 4.0
Berry, low growing subgroup 13-07G......................... 1.5
Brassica, leafy greens, subgroup 4-16B..................... 30
Caneberry, subgroup 13-07A \4\............................. 2
Canistel................................................... 0.7
Cattle, fat................................................ 0.1
Cattle, meat............................................... 0.1
Cattle, meat byproducts.................................... 0.1
Celtuce.................................................... 9
Citrus, dried pulp......................................... 1.0
Citrus, oil................................................ 38
[[Page 39775]]
Coffee, green bean \2\..................................... 0.02
Corn, field, forage........................................ 8.0
Corn, field, grain......................................... 0.05
Corn, field, stover........................................ 7
Corn, field, refined oil................................... 0.1
Corn, pop, grain........................................... 0.05
Corn, pop, stover.......................................... 7
Corn, sweet, cannery waste................................. 0.6
Corn, sweet, forage........................................ 7.0
Corn, sweet, kernel plus cob with husks removed............ 0.04
Corn, sweet, stover........................................ 4.0
Cotton, gin byproducts..................................... 3.0
Cottonseed subgroup 20C.................................... 0.50
Currant \4\................................................ 3
Egg........................................................ 0.04
Fennel, Florence, fresh leaves and stalk................... 9
Flax, seed................................................. 0.40
Fruit, citrus, group 10-10................................. 0.6
Fruit, pome, group 11-10................................... 0.7
Fruit, small vine climbing, except fuzzy kiwifruit, 2.0
subgroup 13-07F...........................................
Fruit, stone, group 12-12.................................. 3
Goat, fat.................................................. 0.1
Goat, meat................................................. 0.1
Goat, meat byproducts...................................... 0.1
Grain, aspirated fractions................................. 10
Grape, raisin.............................................. 5.0
Grass, forage.............................................. 12
Grass, hay................................................. 17
Herbs, subgroup 19A........................................ 200
Hog, fat................................................... 0.05
Hog, meat.................................................. 0.05
Hog, meat byproducts....................................... 0.05
Hop, dried cones........................................... 11.0
Horse, fat................................................. 0.1
Horse, meat................................................ 0.1
Horse, meat byproducts..................................... 0.1
Kohlrabi................................................... 2
Leaf petiole vegetable subgroup 22B........................ 9
Leafy greens subgroup 4-16A................................ 30
Mango...................................................... 0.7
Milk....................................................... 0.02
Nut, tree, group 14-12..................................... 0.04
Oat, forage................................................ 0.3
Oat, grain................................................. 0.05
Oat, hay................................................... 0.3
Oat, straw................................................. 5.0
Onion, bulb, subgroup 3-07A................................ 0.04
Onion, green, subgroup 3-07B............................... 1.5
Papaya..................................................... 0.7
Pea, dwarf, edible podded \4\.............................. 1.5
Pea, field, hay............................................ 15
Pea, field, vines.......................................... 4
Pea, green, edible podded \4\.............................. 1.5
Pea, pigeon, edible podded \4\............................. 1.5
Pea, snap, edible podded \4\............................... 1.5
Pea, snow, edible podded \4\............................... 1.5
Pea, sugar snap, edible podded\4\.......................... 1.5
Pea and bean, succulent shelled, subgroup 6B \4\........... 0.2
Peanut, hay................................................ 4.0
Peanut..................................................... 0.05
Poultry, fat............................................... 0.04
Poultry, meat.............................................. 0.04
Poultry, meat byproducts................................... 0.04
Radish, tops............................................... 10
Rice, grain................................................ 3.5
Rice, hulls................................................ 8
Sapodilla.................................................. 0.7
Sapote, black.............................................. 0.7
Sapote, mamey.............................................. 0.7
Sheep, fat................................................. 0.1
Sheep, meat................................................ 0.1
[[Page 39776]]
Sheep, meat byproducts..................................... 0.1
Soybean, forage............................................ 10.0
Soybean, hay............................................... 25.0
Soybean, seed.............................................. 0.08
Spice group 26............................................. 30
Star apple................................................. 0.7
Tea, dried \3\............................................. 5
Tea, instant \3\........................................... 5
Tropical and subtropical, small fruit, edible peel, 0.3
subgroup 23A \4\..........................................
Vegetable, Brassica, head and stem, group 5-16............. 2
Vegetable, cucurbit, group 9............................... 0.50
Vegetable, fruiting, group 8-10............................ 0.5
Vegetable, legume, bean, edible podded, subgroup 6-22A..... 1.5
Vegetable, legume, pulse, bean, dried shelled, except 0.06
soybean, subgroup 6-22E...................................
Vegetable, legume, pulse, pea, dried shelled, subgroup 6- 0.2
22F.......................................................
Vegetable, root, except sugar beet, subgroup 1B............ 0.1
Vegetable, tuberous and corm, subgroup 1C.................. 0.04
Wheat, bran................................................ 0.15
Wheat, forage.............................................. 0.3
Wheat, grain............................................... 0.05
Wheat, hay................................................. 0.2
Wheat, straw............................................... 5.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of September 27, 1999, for use on
banana.
\2\ There are no U.S. registrations as of January 18, 2012, for use on
coffee, green bean.
\3\ There are no U.S. registrations as of June 24, 2019, for use on tea.
\4\ There are no U.S. registrations on this commodity as of January 11,
2022.
* * * * *
[FR Doc. 2023-13023 Filed 6-16-23; 8:45 am]
BILLING CODE 6560-50-P
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