Rule2022-10868
Fluopicolide; 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
May 23, 2022
Effective
May 23, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of fluopicolide in or on multiple commodities which are identified and discussed later in this document. Valent U.S.A. LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 87 Issue 99 (Monday, May 23, 2022)</title>
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[Federal Register Volume 87, Number 99 (Monday, May 23, 2022)]
[Rules and Regulations]
[Pages 31186-31190]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10868]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0728; FRL-9622-01-OCSPP]
Fluopicolide; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fluopicolide in or on multiple commodities which are identified and
discussed later in this document. Valent U.S.A. LLC requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 23, 2022. Objections and
requests for hearings must be received on or before July 22, 2022 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-2020-0728, 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 OPP Docket is (202) 566-1744. Due to the public
health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and
Reading Room is open to visitors by appointment only. For the latest
status information on EPA/DC services and access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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#95c7d1d3c7dbfae1fcf6f0e6d5f0e5f4bbf2fae3"><span class="__cf_email__" data-cfemail="abf9efedf9e5c4dfc2c8ced8ebcedbca85ccc4dd">[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-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(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-2020-0728 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 22, 2022. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0728, 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/
[[Page 31187]]
DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/contacts.html">https://www.epa.gov/dockets/contacts.html</a>. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of June 1, 2021 (86 FR 29229) (FRL-10023-
95), 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
0F8838) by Valent U.S.A. LLC, 1600 Riviera Avenue, Suite 200 Walnut
Creek, CA 94596 U.S.A. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for indirect or inadvertent residues
of the fungicide Fluopicolide, 2,6-dichloro-N-[[3-chloro-5-
(trifluoromethyl)-2-pyridyl]methyl]-benzamide, in or on Cereal grains
(crop group 15), aspirated grain fractions at 0.07 parts per million
(ppm); Cereal grains (crop group 15), grain at 0.02 ppm; Cereal grains
(crop group 15), milled byproducts at 0.07 ppm; Cotton gin byproducts
at 0.20 ppm; Foliage of legume vegetables (crop group 7), forage at
0.15 ppm; Foliage of legume vegetables (crop group 7), hay, straw, and
vines at 0.20 ppm; Forage, fodder and straw of cereal grains (crop
group 16) at 0.50 ppm; Grass forage, fodder, and hay (crop group 17) at
0.50 ppm; Legume vegetables (crop group 6), seed, pea, bean (succulent
or dried, except listed beans) at 0.03 ppm; Nongrass animal feeds (crop
group 18), forage, fodder, straw and hay at 0.50 ppm; Oilseeds (crop
group 20), seed at 0.04 ppm; Oilseeds (crop group 20), refined oil at
0.10 ppm; Peanut nutmeat at 0.04 ppm; Peanut hay at 0.60 ppm; Peanut,
refined oil at 0.10 ppm; and Soybean, refined oil at 0.08 ppm. That
document referenced a summary of the petition prepared by Valent U.S.A.
LLC, the registrant, which is available in the docket, EPA-HQ-OPP-2020-
0728, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in
response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
revised commodity definitions and is establishing several tolerances at
different levels than petitioned-for. The reasons for these changes are
explained in Unit IV.C.
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 fluopicolide including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with fluopicolide follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections of the rule that would repeat
what has been previously published in tolerance rulemakings for the
same pesticide chemical. Where scientific information concerning a
particular pesticide 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 a number of tolerance rulemakings for
fluopicolide, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to fluopicolide and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from those rulemakings as described
further in this rulemaking, as they remain unchanged.
Toxicological profile. For a discussion of the Toxicological
Profile of fluopicolide and one of its metabolites, 2,6-
dichlorobenzamide (BAM), see Unit III.A. of the previous tolerance
rulemaking for fluopicolide published in the Federal Register of March
7, 2018 (83 FR 9703) (FRL-9973-44). Since the March 7, 2018,
rulemaking, an additional oral toxicity study that included evaluation
of the olfactory system was submitted for BAM, and the results have
been incorporated into the current risk assessment. Toxicity to the
olfactory sensory neurons was observed following a single
intraperitoneal exposure of mice to BAM, as were clinical signs of
toxicity (slightly decreased muscle tone, slight loss of pinnae
reflexes) following oral exposure in several short-term assays. In the
newly submitted oral toxicity study in rats, ataxia was observed in
males; however, there were no effects on the olfactory system.
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for both
fluopicolide and BAM used for the risk assessment, see Unit III.B. of
the March 7, 2018, rulemaking. The only change is for BAM, where the
current risk assessment reports the no-observed adverse-effect
concentration (NOAEC) as 12.1 mg/m\3\ for Inhalation Short- and
Intermediate-Term (1-30 days and 1-6 months). The previous rulemaking
reported this point of departure as a no-observed adverse-effect level
(NOAEL) rather than a NOAEC, but the value remains the same.
Exposure assessment. Much of the exposure assessment remains the
same, although the dietary exposure and risk assessments for
fluopicolide and BAM were updated to account for 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, including with respect to drinking water, non-
occupational, and cumulative exposures, see Unit III.C. of the March 7,
2018, rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposures for the new tolerances for indirect or inadvertent
residues of fluopicolide in the commodities identified in this action
that are necessary to support revised rotational crop restrictions.
There are no new use sites proposed. In addition, the dietary exposure
assessments were revised to reflect the updated Dietary Exposure
Evaluation Model that incorporates the What We Eat in
[[Page 31188]]
America (WWEIA) consumption data from 2005-2010.
Fluopicolide acute dietary exposure and risk assessments are not
required because an endpoint attributable to a single dose has not been
identified. This is the same as in the 2018 rulemaking. Fluopicolide
chronic dietary exposure used the same assumptions as the 2018
rulemaking concerning tolerance level residues or maximum field trial
residues, 100 percent crop treated (PCT), default processing factors,
and modeled drinking water estimates.
For BAM, the acute and chronic dietary exposure assessments assumed
the maximum BAM residues from field trial data for either fluopicolide
or dichlobenil (another active ingredient for which BAM is a
metabolite), which is the same as in the 2018 rulemaking. The current
acute and chronic dietary assessments were updated to assume 100 PCT,
default processing factors, and high-end estimates of fluopicolide in
drinking water.
Cancer. Fluopicolide has been classified as ``not likely to be
carcinogenic to humans.''
Therefore, a cancer dietary exposure assessment was not conducted
for the parent fluopicolide. Additionally, EPA has determined BAM's
potential for carcinogenicity is similar to that of dichlobenil, which
is classified as ``group C, possible human carcinogen.'' Quantification
of cancer risk is based on the reference dose (RfD) approach which
requires comparison of the chronic exposure to the RfD. Using this
methodology will adequately account for all chronic toxic effects,
including carcinogenicity, likely to result from exposure to BAM.
Hence, a separate cancer exposure assessment to BAM was not conducted.
Anticipated residue information. Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and information on the anticipated
residue levels of pesticides in or on food and the actual residue
levels of pesticides 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 residue 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.
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 to 1X for fluopicolide. For
BAM, EPA continues to retain the FQPA safety factor of 10X for the
acute dietary exposure scenario for the general population to account
for the use of a lowest-observed-adverse-effect-level (LOAEL) to
extrapolate to a NOAEL. For all other exposure scenarios, EPA continues
to conclude that there are reliable data to support the reduction of
the FQPA safety factor to 1X. See Unit III.D. of the March 7, 2018,
rulemaking for a discussion of the Agency's rationale for these
determinations.
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 the chronic population-adjusted dose (cPAD). Short-, intermediate-,
and chronic-term risks are evaluated by comparing the estimated
aggregate food, water, and residential exposure to the appropriate
points of departure to ensure that an adequate margin of exposure (MOE)
exists. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
An acute aggregate risk assessment takes into account acute
exposure estimates from dietary consumption of food and drinking water.
There were no endpoints attributable to a single dose identified in the
hazard database and an acute dietary endpoint was not selected for
fluopicolide. Therefore, fluopicolide is not expected to pose an acute
risk.
For BAM, acute dietary risks are below the Agency's level of
concern of 100% of the aPAD; they are 45% of the aPAD for infants less
than 1 year old, which is the population subgroup with the highest
exposure estimate. The acute aggregate risk estimates for BAM are equal
to acute dietary (food and drinking water) risk estimates and therefore
are not of concern. For fluopicolide, chronic dietary risks are below
the Agency's level of concern of 100% of the cPAD; they are 15% of the
cPAD for children 1-2 years old, which is the population subgroup with
the highest exposure estimate.
For BAM, the chronic dietary risks are also below the Agency's
level of concern; they are 40% of the cPAD for infants less than 1 year
old, which is the population subgroup with the highest exposure
estimate. As stated in the March 7, 2018, rulemaking, chronic
residential exposure to residues of fluopicolide or BAM is not
expected, so chronic aggregate risks are equal to chronic dietary risks
and are not of concern.
Short-term aggregate risk estimates are equal to the most
conservative residential exposure estimates plus chronic dietary
exposure estimates (considered to be background dietary exposure). For
adults and children 6 to <11 years old, the post-application dermal
exposures from gardens treated with fluopicolide represent the most
conservative residential exposure estimate. For children 1-2 years old,
the most conservative residential exposure estimate is combined dermal
and incidental oral exposure through high contact lawn activity. EPA
has concluded the short-term aggregate MOEs are 500, 670, and 480 for
adults, children 6 to <11 and children 1-2 years old, respectively,
which are above the level of concern of 100 and therefore are not of
concern. For BAM, dermal and inhalation exposures may not be combined
with oral exposures due to different toxicological effects used as the
basis of the selected endpoints. As a result, the aggregate risk
estimates are equivalent to the dietary risk estimates and are not of
concern.
Due to the absence of treatment-related tumors in two adequate
rodent carcinogenicity studies, fluopicolide is classified as ``not
likely to be carcinogenic to humans''; therefore, a quantitative cancer
assessment is not required.
EPA has assumed BAM's potential for carcinogenicity is similar to
that of dichlobenil, which is classified as ``group C, possible human
carcinogen.'' Quantification of cancer risk is based on the RfD
approach which requires comparison of the chronic exposure to the RfD.
Therefore, the chronic aggregate risk estimates, which do not trigger
concerns based on exposures associated with the registered uses, are
considered protective of both non-cancer and cancer effects.
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 fluopicolide residues, including its metabolite.
More detailed information on this action to establish indirect or
inadvertent tolerances in or on multiple commodities can be found in
the document entitled, ``Fluopicolide. Human Health Risk Assessment to
Support a Petition to Establish Tolerances for Indirect or Inadvertent
Residues in/on Legume Vegetables, Cereal Grains, Grasses, Nongrass
Animal Feeds, Oilseeds, and Peanuts'' at https://
[[Page 31189]]
www.regulations.gov, under docket ID number EPA-HQ-OPP-2020-0728.
IV. Other Considerations
A. Analytical Enforcement Methodology
For the analytical enforcement methodology for fluopicolide and
BAM, see Unit IV.A. of the March 7, 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). EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has
established MRLs for fluopicolide in or on straw and fodder (dry) of
cereal grains at 0.2 ppm, which is the only Codex MRL for the
commodities covered by this rulemaking. This MRL is different than the
U.S. tolerance at 0.5 ppm that is being established for residues of
fluopicolide in/on grain, cereal, forage, fodder, and straw, group 16.
EPA cannot harmonize the U.S. tolerance for group 16 with the
corresponding Codex MRL because it could put U.S. growers at risk of
violative residues despite legal use of fluopicolide.
C. Revisions to Petitioned-For Tolerances
EPA is not establishing the petitioned-for tolerances on Oilseeds
(crop group 20), refined oil at 0.10 ppm or Peanut, refined oil at 0.10
ppm because the Agency is establishing tolerances for the respective
raw agricultural commodities, Oilseed group 20 at 0.03 ppm, and Peanut
at 0.03 ppm, which are adequate to cover the refined oils.
EPA is establishing the tolerance level for Soybean, refined oil at
0.03 ppm, which is the level calculated by multiplying average residue
by the processing factor. This tolerance level is lower than the
petitioned-for tolerance level of 0.08 ppm. The petitioner did not
provide a rationale for the petitioned-for tolerance level, so the
reason for this difference is unclear.
Additionally, EPA is revising many of the commodity definitions for
consistency with the Agency's preferred terminology for tolerances. EPA
is also establishing several tolerances at different levels than
petitioned-for to be consistent with Organization for Economic
Cooperation and Development (OECD) rounding class practice.
Specifically, EPA is:
<bullet> Revising ``Nongrass animal feeds (crop group 18), forage,
fodder, straw and hay'' to ``Animal feed, nongrass, group 18'' and
establishing the tolerance level at 0.5 ppm instead of the petitioned-
for 0.50 ppm;
<bullet> Revising ``Cereal grains (crop group 15), aspirated grain
fractions'' to ``Grain, aspirated fractions'' and establishing the
tolerance level at 0.07 ppm;
<bullet> Revising ``Cereal grains (crop group 15), grain'' to
``Grain, cereal, group 15'' and establishing the tolerance level at
0.02 ppm;
<bullet> Revising ``Cereal grains (crop Group 15), milled
byproducts'' to ``Grain, cereal, group 15, milled byproducts'' and
establishing the tolerance level at 0.07 ppm;
<bullet> Establishing the tolerance level for ``Cotton, gin
byproducts'' at 0.2 ppm instead of the petitioned-for 0.20 ppm;
<bullet> Revising ``Forage, fodder and straw of cereal grains (crop
group 16)'' to ``Grain, cereal, forage, fodder, and straw, group 16''
and establishing the tolerance level at 0.5 ppm instead of the
petitioned-for 0.50 ppm;
<bullet> Revising ``Grass forage, fodder, and hay (crop group 17)''
to ``Grass forage, fodder and hay, group 17'' and establishing the
tolerance level at 0.5 ppm instead of the petitioned-for 0.50 ppm;
<bullet> Revising ``Oilseeds (crop group 20), seed'' to ``Oilseed
group 20'' and establishing the tolerance level at 0.03 ppm instead of
the petitioned-for 0.04 ppm;
<bullet> Revising ``Peanut nutmeat'' to ``Peanut'' and establishing
the tolerance level at 0.03 ppm instead of the petitioned-for 0.04 ppm;
<bullet> Establishing the tolerance level for ``Peanut, hay'' at
0.7 ppm instead of the petitioned-for 0.60 ppm;
<bullet> Revising the petitioned-for tolerances for ``Foliage of
legume vegetables (crop group 7), forage'' at 0.15 ppm and ``Foliage of
legume vegetables (crop group 7), hay, straw, and vines'' at 0.20 ppm
to ``Vegetable, foliage of legume, group 7'' at 0.2 ppm; and
<bullet> Revising ``Legume vegetables (crop group 6), seed, pea,
bean (succulent or dried, except listed beans)'' to ``Vegetable,
legume, group 6'' and establishing the tolerance level at 0.02 ppm
instead of the petitioned-for 0.03 ppm.
<bullet> In addition, EPA is removing the existing tolerances for
indirect or inadvertent residues in 40 CFR 180.627(d) because these
commodities are included in the groups 15 and 16 tolerances that the
Agency is establishing in this action. For example, the commodities
``corn, field, grain'' (with an existing tolerance level of 0.01 ppm)
and ``wheat, grain'' (with an existing tolerance level of 0.02 ppm) are
included in the new tolerance for indirect or inadvertent residues in
``grain, cereal, group 15'' at 0.02 ppm. The new tolerances are equal
to or higher than the existing tolerances and are therefore adequate to
cover indirect or inadvertent residues on these commodities.
V. Conclusion
Therefore, tolerances are established for indirect or inadvertent
residues of Fluopicolide, [2,6-dichloro-N-[[3-chloro-5-
(trifluoromethyl)-2-pyridinyl]methyl]benzamide], including its
metabolites and degradates, in or on Animal feed, nongrass, group 18 at
0.5 ppm; Cotton, gin byproducts at 0.2 ppm; Grain, aspirated fractions
at 0.07 ppm; Grain, cereal, group 15 at 0.02 ppm; Grain, cereal, group
15, milled byproducts at 0.07 ppm; Grain, cereal, forage, fodder, and
straw, group 16 at 0.5 ppm; Grass, forage, fodder and hay, group 17 at
0.5 ppm; Oilseed group 20 at 0.03 ppm; Peanut at 0.03 ppm; Peanut, hay
at 0.7 ppm; Soybean, refined oil at 0.03 ppm; Vegetable, foliage of
legume, group 7 at 0.2 ppm; and Vegetable, legume, group 6 at 0.02 ppm.
Upon establishment of the aforementioned tolerances, the
established tolerances for indirect or inadvertent residues of
fluopicolide in 40 CFR 180.627(d) will be removed, as they are
superseded by the new tolerances.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not
[[Page 31190]]
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 17, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.627 amend paragraph (d) by designating the table as
table 1 and revising newly designated table 1 to read as follows:
Sec. 180.627 Fluopicolide; tolerances for residues.
* * * * *
(d) * * *
Table 1 to Paragraph (d)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Animal feed, nongrass, group 18............................. 0.5
Cotton, gin byproducts...................................... 0.2
Grain, aspirated fractions.................................. 0.07
Grain, cereal, group 15..................................... 0.02
Grain, cereal, group 15, milled byproducts.................. 0.07
Grain, cereal, forage, fodder, and straw, group 16.......... 0.5
Grass, forage, fodder and hay, group 17..................... 0.5
Oilseed group 20............................................ 0.03
Peanut...................................................... 0.03
Peanut, hay................................................. 0.7
Soybean, refined oil........................................ 0.03
Vegetable, foliage of legume, group 7....................... 0.2
Vegetable, legume, group 6.................................. 0.02
------------------------------------------------------------------------
[FR Doc. 2022-10868 Filed 5-20-22; 8:45 am]
BILLING CODE 6560-50-P
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