[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 [www.gpo.gov]
[FR Doc No: 2022-10868]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001.
    The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Public Reading Room and 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 https://www.epa.gov/dockets.

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: 
[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(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:
     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/

[[Page 31187]]

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/contacts.html. 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 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, https://www.regulations.gov. 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:
     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;
     Revising ``Cereal grains (crop group 15), aspirated grain 
fractions'' to ``Grain, aspirated fractions'' and establishing the 
tolerance level at 0.07 ppm;
     Revising ``Cereal grains (crop group 15), grain'' to 
``Grain, cereal, group 15'' and establishing the tolerance level at 
0.02 ppm;
     Revising ``Cereal grains (crop Group 15), milled 
byproducts'' to ``Grain, cereal, group 15, milled byproducts'' and 
establishing the tolerance level at 0.07 ppm;
     Establishing the tolerance level for ``Cotton, gin 
byproducts'' at 0.2 ppm instead of the petitioned-for 0.20 ppm;
     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;
     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;
     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;
     Revising ``Peanut nutmeat'' to ``Peanut'' and establishing 
the tolerance level at 0.03 ppm instead of the petitioned-for 0.04 ppm;
     Establishing the tolerance level for ``Peanut, hay'' at 
0.7 ppm instead of the petitioned-for 0.60 ppm;
     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
     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.
     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


