Document ID: EPA-HQ-OPP-2020-0419-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fludioxonil
Posted Date: 2022-02-09T05:00Z

[Federal Register Volume 87, Number 27 (Wednesday, February 9, 2022)]
[Rules and Regulations]
[Pages 7388-7393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02560]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0419 and EPA-HQ-OPP-2021-0020; FRL-9482-01-OCSPP]

Fludioxonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes or amends tolerances for residues 
of fludioxonil in or on multiple crops that are referenced later in 
this document. The Interregional Project Number 4 (IR-4) and Syngenta 
Crop Protection, LLC requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 9, 2022. Objections and 
requests for hearings must be received on or before April 11, 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 dockets for this action, identified by docket 
identification (ID) numbers EPA-HQ-OPP-2020-0419 and EPA-HQ-OPP-2021-
0020, are available online at https://www.regulations.gov or in-person 
at the Office of Pesticide Programs Regulatory Public Docket (OPP 
Docket) in the Environmental Protection Agency Docket Center (EPA/DC), 
West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. 
NW, Washington, DC 20460-0001.
    Due to the public health emergency, 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, docket

[[Page 7389]]

access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID numbers EPA-HQ-OPP-2020-0419 and EPA-HQ-OPP-2021-0020 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 April 11, 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 numbers EPA-HQ-OPP-2020-0419 and EPA-
HQ-OPP-2021-0020, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 28, 2021 (86 FR 33922) (FRL-10025-
08) and in the Federal Register of February 25, 2021 (86 FR 11488) 
(FRL-10020-47), 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 0E8847) by IR-4, North Carolina State University, 1730 
Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The February 
25, 2021, notice erroneously identified Syngenta as the petitioner. The 
petition requested that 40 CFR 180.516 be amended by establishing 
tolerances for residues of fludioxonil, [4-(2, 2-difluoro-1,3-
benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile] in or on the raw 
agricultural commodities: Carrot, roots at 7 parts per million (ppm); 
Celtuce at 15 ppm; Cottonseed subgroup 20C at 0.05 ppm; Dragon fruit at 
20 ppm; Durian at 20 ppm; Fennel, Florence, fresh leaves and stalk at 
15 ppm; Jackfruit at 20 ppm; Leaf petiole vegetable subgroup 22B at 15 
ppm; Leafy greens subgroup 4-16A at 30 ppm; Mangosteen at 5 ppm; 
Persimmon, Japanese at 5 ppm; Sunflower subgroup 20B at 0.01 ppm; 
Tropical and subtropical, small fruit, inedible peel, subgroup 24A at 
20 ppm; Vegetable, legume, group 6, except bean, dry and bean, 
succulent at 0.01 ppm; Vegetable, root, except sugar beet, subgroup 1B, 
except carrot and ginseng at 0.75 ppm; and Vegetable, tuberous and 
corm, subgroup 1C, except yam, true, tuber at 6 ppm. The petition also 
requested to remove established tolerances for residues of fludioxonil, 
[4-(2, 2-difluoro-1,3- benzodioxol-4-yl)-1H-pyrrole-3- carbonitrile] in 
or on the raw agricultural commodities: Carrots at 7.0 ppm; Cotton, 
undelinted seed at 0.05 ppm; Dragon fruit at 1.0 ppm; Leaf petioles 
subgroup 4B at 15 ppm; Leafy greens subgroup 4A at 30 ppm; Longan at 20 
ppm; Lychee at 20 ppm; Melon subgroup 9A at 0.03 ppm; Safflower, seed 
at 0.01 ppm; Spanish lime at 20 ppm; Sunflower, seed at 0.01 ppm; 
Vegetable, legume, group 6 at 0.01 ppm; Vegetable, root, except sugar 
beet, subgroup 1B at 0.75 ppm; and Vegetable, tuberous and corm, 
subgroup 1C at 6.0 ppm. That document referenced a summary of the 
petition prepared by Syngenta Crop Protection, the registrant, which is 
available in docket ID number EPA-HQ-OPP-2020-0419 at https://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Also, in the Federal Register of February 25, 2021 (86 FR 11488) 
(FRL-10020-47) 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 0F8858) by Syngenta Crop Protection, LLC, P.O. Box 18300, 
Greensboro, NC 27419. The petition requested that 40 CFR 180.516 be 
amended by establishing tolerances for residues of fludioxonil, [4-(2, 
2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile] in or on 
the raw agricultural commodities tree nut crop group 14-12, except 
pistachios at 0.2 ppm and almond hulls at 15 ppm. That document 
referenced a summary of the petition prepared by Syngenta Crop 
Protection, the registrant, which is available in docket ID number EPA-
HQ-OPP-2021-0020 at 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 is 
establishing one tolerance at a different level than petitioned for, 
has modified the nut tolerances, and has modified some of the commodity 
definitions. A discussion of these modifications can be found in unit 
IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    FFDCA Section 408(b)(2)(A)(i) allows EPA to establish a tolerance 
(the legal limit for a pesticide chemical residue in

[[Page 7390]]

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 in FFDCA section 408(b)(2)(D), 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 fludioxonil including exposure 
resulting from the tolerance established by this action. EPA's 
assessment of exposures and risks associated with fludioxonil 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 republishing the same sections is unnecessary. 
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 
fludioxonil in which EPA concluded, based on the available information, 
that there is a reasonable certainty that no harm would result from 
aggregate exposure to fludioxonil 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 fludioxonil, see Unit III.A. of the November 6, 2018, final 
rulemaking (83 FR 55491) (FRL-9982-75).
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern for 
fludioxonil used for human risk assessment, please reference Unit 
III.B. of the August 14, 2015, rulemaking (80 FR 48743) (FRL-9931-06).
    Exposure assessment. Much of the exposure assessment remains the 
same although updates have occurred to accommodate exposures from the 
petitioned-for tolerances. These updates are discussed in this section; 
for a description of the rest of the EPA approach to and assumptions 
for the exposure assessment, please reference Unit III.C. of the 
November 6, 2018, rulemaking.
    EPA's dietary exposure assessments have been updated to include the 
additional exposure from the new uses of fludioxonil on the crops and 
the crop group conversions and expansions requested in these actions. 
The dietary exposure assessment used the same assumptions as the 
November 6, 2018, final rule, including tolerance level residues and 
100 percent crop treated (PCT).
    Drinking water exposure. The new uses do not result in an increase 
in the estimated residue levels in drinking water, so the estimated 
drinking water concentrations used in 2018 final rule are the same as 
those used in this assessment.
    Non-occupational exposure. The assessment used the same assumptions 
as the November 6, 2018, final rule. The residential exposures used in 
the aggregate assessment are inhalation exposures from handlers 
applying paints with airless sprayers for adults and incidental oral 
exposures (hand-to-mouth) from post-application exposure to outdoor 
treated turf for children 1 to <2 years old.
    Cumulative exposure. 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 
fludioxonil and any other substances and fludioxonil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
fludioxonil 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. See Unit III.D. of the 
November 6, 2018, 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 
aggregate exposure estimates to the acute population adjusted dose 
(aPAD) and chronic population adjusted dose (cPAD). Short-, 
intermediate-, and chronic-term risks are evaluated by comparing the 
estimated 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 dietary exposure assessment was not performed as there 
were no appropriate toxicological effects attributable to a single 
exposure (dose) observed in available oral toxicity studies, including 
maternal toxicity in the developmental toxicity studies. Fludioxonil is 
not expected to pose an acute risk. Chronic dietary risks are below the 
Agency's level of concern of 100% of the cPAD: They are 52% of the cPAD 
for children 1 to 2 years old, the group with the highest exposure. EPA 
has concluded the combined short-term food, water, and residential 
exposures result in margins of exposure above the level of concern of 
100 for all scenarios assessed and are not of concern. Intermediate- 
and long-term aggregate risk assessments were not performed because 
there are no registered or proposed uses of fludioxonil that result in 
intermediate- or long-term residential exposures. A cancer dietary 
exposure and risk assessment was not conducted for fludioxonil as it is 
a Group D chemical--not classifiable as to human carcinogenicity.
    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 fludioxonil residues. More detailed information 
on this action can be found in the document titled ``Fludioxonil. Human 
Health Risk Assessment for Section 3 Registration for Crop Group 
Conversions/Expansions for Cottonseed subgroup 20C, Fennel, Florence, 
Fresh Leaves and Stalk; Leaf Petiole Vegetable Subgroup 22B; Leafy 
Greens Subgroup 4-16A; Sunflower Subgroup 20B, Tropical and 
Subtropical, Small Fruit, Inedible Peel, Subgroup 24A and to Establish 
an Individual Tolerance for Residues in/on Tree Nuts Crop Group 14-12, 
Dragon Fruit, Durian, Japanese Persimmon,

[[Page 7391]]

Jackfruit, and Mangosteen.'' (hereafter ``the Fludioxonil Human Health 
Risk Assessment'') in docket ID numbers EPA-HQ-OPP-2020-0419 and EPA-
HQ-OPP-2021-0020.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the November 6, 2018, rulemaking.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4).
    The U.S. tolerances for cottonseed subgroup 20C; leaf petiole 
vegetable subgroup 22B; and persimmon, Japanese are harmonized with 
Codex MRLs. There are no Codex MRLs for many of the commodities 
included in this action, including almond; almond, hulls; celtuce; 
dragon fruit; durian; jackfruit; mangosteen; pecan; sugar apple; 
sunflower subgroup 20B; and tropical and subtropical, small fruit, 
inedible peel, subgroup 24A.
    Several U.S. tolerances are higher than the corresponding Codex 
MRLs. The following U.S. tolerances cannot be harmonized with Codex 
because U.S. growers could have violative residues despite legal use of 
fludioxonil: Carrot, roots at 7 ppm (Codex MRL is 1 ppm) and fennel, 
Florence, fresh leaves and stalk at 15 ppm (Codex MRL is 9 ppm).
    The U.S. tolerance for vegetable, legume group 6 at 0.01 ppm 
reflects seed treatment use. It is not appropriate to harmonize with 
the significantly higher Codex MRL of 0.6 ppm because the tolerance 
would not be effective for determining misuse. For a few other U.S. 
subgroup tolerances, EPA is not harmonizing with relevant Codex MRLs, 
which are established for individual commodities and vary widely among 
those commodities. The available representative commodity data support 
the crop subgroup and EPA's general approach is to establish a crop 
group or subgroup tolerance when supported by available representative 
commodity data, rather than break up the group or subgroup for 
harmonization purposes. The U.S. tolerance for leafy greens subgroup 4-
16A at 30 ppm is not harmonized with all relevant Codex MRLs for 
commodities in that group (e.g., head lettuce at 10 ppm and leaf 
lettuce at 40 ppm), although it is harmonized with the tolerance for 
spinach. The registrant requested that the leafy greens subgroup 4-16A 
tolerance be harmonized with the Canadian MRL of 30 ppm because Canada 
is a major trading partner with the U.S. for these crops. For 
vegetable, root, except sugar beet, subgroup 1B, the U.S. tolerance is 
harmonized with the Canadian MRL at 0.75 ppm, rather than splitting the 
group and harmonizing individually with the Codex MRLs of 4 ppm for 
ginseng, root and 0.3 ppm for radish, root. Finally, the U.S. tolerance 
for vegetable, tuberous and corm, subgroup 1C is harmonized with the 
Canadian MRL at 6 ppm, rather than splitting the group and harmonizing 
individually with the Codex MRLs of 5 ppm for potato and 10 ppm for 
sweet potato. Finally, EPA is not harmonizing the U.S. tolerance for 
vegetable, cucurbit, group 9 with the Codex MRL of 0.5 ppm because the 
registrant requested that EPA harmonize this tolerance group with the 
Canadian MRL of 0.45 ppm instead because Canada is a major trading 
partner for these crops.

C. Revisions to Petitioned-For Tolerances

    One petitioner requested an exception for carrot and ginseng from 
vegetable, root, except sugar beet, subgroup 1B; and yam, true, tuber 
from vegetable, tuberous and corm, subgroup 1C. EPA is not excepting 
carrot and yam from their respective subgroups because representative 
crops may not be excepted from a crop subgroup under 40 CFR 180.40(h). 
Although an individual tolerance has been established for ginseng, EPA 
does not believe it is necessary to exclude ginseng from the vegetable, 
root, except sugar beet, subgroup 1B tolerance, as residues will be 
enforced according to the higher tolerance. EPA is adjusting the 
tolerance level for vegetable, tuberous and corm, subgroup 1C to be 
consistent with Agency rounding class practice. For tree nut crop group 
14-12, maximum fludioxonil residues in representative crops were not 
within a factor of five of each other. Based on the residue data, the 
recommended tolerance for residues in/on almond is 0.2 ppm and the 
recommended tolerance for residues in/on pecan is 0.01 ppm. In those 
circumstances, the Agency will normally establish individual crop 
tolerances, if supported by the available residue data. EPA has 
determined that the available data supports individual nut tolerance 
levels, based on translation from the representative commodities to the 
various nut commodities as specified in the 2010 EPA analysis of IR-4's 
petition to amend crop group. See U.S. EPA, Memorandum re: ``Crop 
Grouping--Part IX: Analysis of the USDA IR-4 Petition to Amend the Crop 
Group Regulation 40 CFR 180.41(c)(16) and Commodity Definitions (40 CFR 
180.1(g)) Related to the Crop Group 14 Tree Nuts. Part I. Analysis.'' 
at 134-136 (Sept. 30, 2010). Specifically, EPA is establishing 
tolerances of 0.2 ppm for the nut commodities that identified almond as 
the representative commodity and tolerances of 0.01 ppm for the nut 
commodities that identified pecan as the representative commodity.

V. Conclusion

    Therefore, tolerances are established for residues of fludioxonil 
in or on African Tree Nut at 0.01 ppm; Almond at 0.2 ppm; Almond, hulls 
at 15 ppm; Beechnut at 0.2 ppm; Brazil nut at 0.01 ppm; Brazilian pine 
at 0.2 ppm; Bunya at 0.2 ppm; Bur oak at 0.01 ppm; Butternut at 0.01 
ppm; Cajou at 0.01 ppm; Candlenut at 0.2 ppm; Carrot, roots at 7 ppm; 
Cashew at 0.01 ppm; Celtuce at 15 ppm; Chestnut at 0.2 ppm; Chinquapin 
at 0.2 ppm; Coconut at 0.01 ppm; Coquito nut at 0.01 ppm; Cottonseed 
subgroup 20C at 0.05 ppm; Dika nut at 0.01 ppm; Durian at 20 ppm; 
Fennel, Florence, fresh leaves and stalk at 15 ppm; Ginkgo at 0.2 ppm; 
Guiana chestnut at 0.01 ppm; Hazelnut at 0.01 ppm; Heartnut at 0.01 
ppm; Hickory nut at 0.01 ppm; Jackfruit at 20 ppm; Japanese horse-
chestnut at 0.01 ppm; Leaf petiole vegetable subgroup 22B at 15 ppm; 
Leafy greens subgroup 4-16A at 30 ppm; Macadamia nut at 0.01 ppm; 
Mangosteen at 5 ppm; Mongongo nut at 0.01 ppm; Monkey puzzle at 0.2 
ppm; Monkey-pot at 0.01 ppm; Okari nut at 0.2 ppm; Pachira nut at 0.01 
ppm; Peach palm nut at 0.2 ppm; Pecan at 0.01 ppm; Pequi at 0.2 ppm; 
Persimmon, Japanese at 5 ppm; Pili nut at 0.2 ppm; Pine nut at 0.2 ppm; 
Sapucaia nut at 0.01 ppm; Sunflower subgroup 20B at 0.01 ppm; Tropical 
almond at 0.2 ppm; Tropical and subtropical, small fruit, inedible 
peel, subgroup 24A at 20 ppm; Walnut, black at 0.01 ppm; Walnut, 
English at 0.01 ppm; and Yellowhorn at 0.01 ppm.
    EPA is amending the tolerance for Dragon fruit from 1.0 ppm to 20 
ppm, the tolerance for Pistachio from 0.10 ppm to 0.1 ppm, and the 
tolerance for Vegetable, tuberous and corm, subgroup 1C from 6.0 ppm to 
6 ppm. The commodity definition for Vegetable, legume, group 6 is 
amended to Vegetable, legume, group 6, except bean while maintaining 
the tolerance at 0.01 ppm.

[[Page 7392]]

    Additionally, the following tolerances are removed as unnecessary 
due to the establishment of the above tolerances: Carrots at 7.0 ppm; 
Cotton, undelinted seed at 0.05 ppm; Leaf petioles subgroup 4B at 15 
ppm; Leafy greens subgroup 4A at 30 ppm; Longan at 20 ppm; Lychee at 20 
ppm; Safflower, seed at 0.01 ppm; Spanish lime at 20 ppm; and 
Sunflower, seed at 0.01 ppm. In addition, EPA is removing the tolerance 
for the Melon subgroup, since it is unnecessary due to the tolerance 
for cucurbit vegetables, group 9 at 0.45 ppm.

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 (CRA)

    Pursuant to the CRA (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: February 2, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
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.  180.516, amend the table in paragraph (a) (1) by:
0
a. Adding in alphabetical order the entries ``African Tree Nut''; 
``Almond''; ``Almond, hulls''; ``Beechnut''; ``Brazil nut''; 
``Brazilian pine''; ``Bunya''; ``Bur oak''; ``Butternut''; ``Cajou''; 
and ``Candlenut''.
0
b. Removing the entry for ``Carrots''.
0
c. Adding in alphabetical order the entries ``Carrot, roots''; 
``Cashew''; ``Celtuce''; ``Chestnut''; ``Chinquapin''; ``Coconut''; 
``Coquito nut''; and ``Cottonseed subgroup 20C''.
0
d. Removing the entry for ``Cotton, undelinted seed''.
0
e. Adding in alphabetical order the entry ``Dika nut''.
0
f. Revising the entry for ````Dragon fruit''.
0
g. Adding in alphabetical order the entries ``Durian''; ``Fennel, 
Florence, fresh leaves and stalk''; ``Ginkgo''; ``Guiana chestnut''; 
``Hazelnut''; ``Heartnut''; ``Hickory nut''; ``Jackfruit''; and 
``Japanese horse-chestnut''.
0
h. Removing the entry for ``Leaf petioles subgroup 4B''.
0
i. Adding in alphabetical order the entry ``Leaf petiole vegetable 
subgroup 22B''.
0
j. Removing the entry for ``Leafy greens subgroup 4A''.
0
k. Adding in alphabetical order the entry ``Leafy greens subgroup 4-
16A''.
0
l. Removing the entries for ``Longan''; and ``Lychee''.
0
m. Adding in alphabetical order the entries ``Macadamia nut''; and 
``Mangosteen''.
0
n. Removing the entry for ``Melon subgroup 9A''.
0
o. Adding in alphabetical order the entries ``Mongongo nut''; ``Monkey 
puzzle''; ``Monkey-pot''; ``Okari nut''; ``Pachira nut''; ``Peach palm 
nut''; ``Pecan''; ``Pequi''; ``Persimmon, Japanese''; ``Pili nut''; and 
``Pine nut''.
0
p. Revising the entry for ``Pistachio''.
0
q. Removing the entry for ``Safflower, seed''.
0
r. Adding in alphabetical order the entry ``Sapucaia nut''.
0
s. Removing the entries for ``Spanish lime''; and ``Sunflower, seed''.
0
t. Adding in alphabetical order the entries ``Sunflower subgroup 20B''; 
``Tropical almond''; and ``Tropical and subtropical, small fruit, 
inedible peel, subgroup 24A''.
0
u. Removing the entry for ``Vegetable, legume, group 6''.
0
v. Adding in alphabetical order the entry ``Vegetable, legume, group 6, 
except bean''.
0
w. Revising the entry for ``Vegetable, tuberous and corm, subgroup 
1C''.
0
x. Adding in alphabetical order the entries ``Walnut, black''; 
``Walnut, English''; and ``Yellowhorn''.
    The additions and revisions read as follows:

Sec.  180.516   Fludioxonil; tolerances for residues.

    (a) * * *
    (1) * * *

[[Page 7393]]

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
African Tree Nut............................................        0.01
Almond......................................................         0.2
Almond, hulls...............................................          15
 
                                * * * * *
Beechnut....................................................         0.2
 
                                * * * * *
Brazil nut..................................................        0.01
Brazilian pine..............................................         0.2
Bunya.......................................................         0.2
Bur oak.....................................................        0.01
 
                                * * * * *
Butternut...................................................        0.01
Cajou.......................................................        0.01
Candlenut...................................................         0.2
 
                                * * * * *
Carrot, roots...............................................           7
Cashew......................................................        0.01
Celtuce.....................................................          15
 
                                * * * * *
Chestnut....................................................         0.2
Chinquapin..................................................         0.2
 
                                * * * * *
Coconut.....................................................        0.01
Coquito nut.................................................        0.01
 
                                * * * * *
Cottonseed subgroup 20C.....................................        0.05
 
                                * * * * *
Dika nut....................................................        0.01
Dragon fruit................................................          20
Durian......................................................          20
 
                                * * * * *
Fennel, Florence, fresh leaves and stalk....................          15
 
                                * * * * *
Ginkgo......................................................         0.2
 
                                * * * * *
Guiana chestnut.............................................        0.01
Hazelnut....................................................        0.01
Heartnut....................................................        0.01
 
                                * * * * *
Hickory nut.................................................        0.01
 
                                * * * * *
Jackfruit...................................................          20
Japanese horse-chestnut.....................................        0.01
 
                                * * * * *
Leaf petiole vegetable subgroup 22B.........................          15
Leafy greens subgroup 4-16A.................................          30
Macadamia nut...............................................        0.01
 
                                * * * * *
Mangosteen..................................................           5
Mongongo nut................................................        0.01
Monkey puzzle...............................................         0.2
Monkey-pot..................................................        0.01
Okari nut...................................................         0.2
 
                                * * * * *
Pachira nut.................................................        0.01
 
                                * * * * *
Peach palm nut..............................................         0.2
 
                                * * * * *
Pecan.......................................................        0.01
Pequi.......................................................         0.2
Persimmon, Japanese.........................................           5
Pili nut....................................................         0.2
Pine nut....................................................         0.2
 
                                * * * * *
Pistachio...................................................         0.1
 
                                * * * * *
Sapucaia nut................................................        0.01
 
                                * * * * *
Sunflower subgroup 20B......................................        0.01
 
                                * * * * *
Tropical almond.............................................         0.2
Tropical and subtropical, small fruit, inedible peel,                 20
 subgroup 24A...............................................
 
                                * * * * *
Vegetable, legume, group 6, except bean.....................        0.01
 
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C...................           6
Walnut, black...............................................        0.01
Walnut, English.............................................        0.01
 
                                * * * * *
Yellowhorn..................................................        0.01
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of July 28, 2021.

* * * * *
[FR Doc. 2022-02560 Filed 2-8-22; 8:45 am]
BILLING CODE 6560-50-P