Document ID: EPA-HQ-OPP-2021-0744-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Fludioxonil
Posted Date: 2023-03-29T04:00Z

[Federal Register Volume 88, Number 60 (Wednesday, March 29, 2023)]
[Rules and Regulations]
[Pages 18428-18431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06457]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0744; FRL-10769-01-OCSPP]

Fludioxonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation modifies existing tolerances for residues of 
fludioxonil in or on mango and papaya. Syngenta Crop Protection, LLC 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective March 29, 2023. Objections and 
requests for hearings must be received on or before May 30, 2023, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2021-0744, 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 the OPP Docket is (202) 566-1744. Please review the 
visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, 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 Government 
Publishing Office's e-CFR site at https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2021-0744 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 
May 30, 2023. 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-2021-0744, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 24, 2022 (87 FR 64196) (FRL-
9410-06-OCSPP), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 1E8947) by Syngenta Crop Protection, LLC, 410

[[Page 18429]]

Swing Road, Greensboro, NC 27409. The petition requested that 40 CFR 
180.516 be amended by establishing import tolerances for residues of 
the fungicide fludioxonil, [4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-
pyrrole-3-carbonitrile], in or on mango at 15 parts per million (ppm) 
and papaya at 8 ppm. That document referenced a summary of the petition 
prepared by Syngenta Crop Protection, LLC, the registrant, which is 
available in the docket, 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 and in 
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA 
is modifying the existing tolerances for residues of fludioxonil in or 
on mango and papaya at different levels than requested. 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 fludioxonil, including exposure resulting from 
the tolerances modified 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 of the rule that repeat what 
has been previously published in tolerance rulemakings for the same 
pesticide chemical. Where scientific information concerning a 
particular chemical remains unchanged, the content of those sections 
would not vary between tolerance rulemakings, and EPA considers 
referral back to those sections as sufficient to provide an explanation 
of the information EPA considered in making its safety determination 
for the new rulemaking.
    EPA has previously published 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 rule, as 
they remain unchanged.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Specific information on the studies received and the nature of the 
adverse effects caused by fludioxonil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in Unit III.A. of 
the final rule published in the Federal Register of November 6, 2018 
(83 FR 55491) (FRL-9982-75).

B. Toxicological Points of Departure/Levels of Concern

    A summary of the toxicological endpoints for fludioxonil used for 
human health risk assessment is discussed in Unit III.B. of the final 
rule published in the Federal Register of August 14, 2015 (80 FR 48743) 
(FRL-9931-06).

C. 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.
    1. Dietary exposure from food and feed uses. EPA's dietary exposure 
assessments have been updated to include the additional exposure from 
the petitioned-for tolerances for residues of fludioxonil on mango and 
papaya. An acute dietary risk assessment was not performed since no 
endpoint attributable to a single exposure (dose) was identified from 
the available oral toxicity database. The chronic assessment is based 
on tolerance-level residues and assumes 100 percent crop treated (PCT); 
the chronic assessment is unrefined. The assessment was conducted using 
the Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID), Version 4.02, which incorporates 2005-2010 
food consumption information from the United States Department of 
Agriculture's (USDA's) National Health and Nutrition Examination 
Survey, What We Eat in America, (NHANES/WWEIA). 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.
    2. Dietary exposure from drinking water. The proposed post-harvest 
application uses on imported fruit do not result in an increase in the 
estimated residue levels in drinking water, so the estimated drinking 
water concentrations used in the November 6, 2018, final rule are the 
same as those used in this assessment.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). The assessment used 
the same assumptions as the November 6, 2018. 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.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, leave in effect, or revoke a 
tolerance, the Agency consider ``available information'' concerning the 
cumulative effects of a particular pesticide's residues and ``other 
substances that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common

[[Page 18430]]

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.

D. 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.

E. 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). For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-, intermediate-, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate points of departure (PODs) to ensure that an 
adequate margin of exposure (MOE) exists.
    An acute dietary exposure assessment was not performed as there 
were no indication of an adverse effects attributable to a single dose. 
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 14% of the cPAD for the general population and 49% of the cPAD for 
children 1-2 years old, the population subgroup receiving the highest 
exposure.
    EPA has concluded the combined short-term food, water, and 
residential exposures result in aggregate MOEs of 1200 for adults and 
290 for children 1-2 years old. Because EPA's level of concern for 
fludioxonil is an MOE of 100 or below, short-term aggregate risks 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. Fludioxonil is not classifiable as to human carcinogenicity; 
therefore, EPA does not expect exposures to pose an aggregate cancer 
risk.
    Therefore, based on the risk assessments and information described 
above, EPA concludes that there is a reasonable certainty that no harm 
will result to the general population, or to infants and children, from 
aggregate exposure to fludioxonil residues. More detailed information 
on this action can be found in the document titled ``Fludioxonil. Human 
Health Risk Assessment for the Proposed Tolerances without a U.S. 
Registration for Residues of Fludioxonil in/on Mango and Papaya.'' in 
docket ID number EPA-HQ-OPP-2021-0744.

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).
    There is no Codex MRL for fludioxonil in or on papaya. Canada has 
established an MRL for fludioxonil in or on papaya at 5 ppm, which is 
the same as the U.S. tolerance as modified by this action. Codex and 
Canada have established MRLs for fludioxonil in or on mango at 2 ppm. 
These MRLs are different than the U.S. tolerance as modified by this 
action, which is 8 ppm for fludioxonil residues in or on mango. EPA is 
not harmonizing the U.S. tolerance with the Codex and Canadian MRLs 
because the proposed post-harvest application use on fruit imported 
into the United States results in residues greater than 2 ppm. The 
increased tolerance of 8 ppm is needed to cover residues resulting from 
post-harvest application to imported fruit and would not affect trade 
channels with Canada or the European Union.

C. Revisions to Petitioned-For Tolerances

    The registrant petitioned for import tolerances of 15 ppm for mango 
and 8 ppm for papaya. However, EPA has previously established 
tolerances for residues of fludioxonil in or on mango and papaya, both 
at 5.0 ppm, at 40 CFR 180.516. In this action, EPA is modifying these 
established tolerances by increasing the tolerance for mango to 8 ppm 
and revising the tolerance for papaya to 5 ppm based on the submitted 
field trial data, Organization for Economic Co-operation and 
Development (OECD) tolerance calculation procedures, and rounding 
rules. These tolerances are inclusive of imported commodities as well 
as domestically produced.

V. Conclusion

    Therefore, tolerances are modified for residues of fludioxonil, [4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile], in or 
on mango at 8 ppm and papaya at 5 ppm.

VI. Statutory and Executive Order Reviews

    This action modified tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 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

[[Page 18431]]

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: March 16, 2023.
Daniel Rosenblatt,
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, revise the commodities ``mango'' and ``papaya'' in 
the table in paragraph (a)(1) to read as follows:

Sec.  180.516  Fludioxonil; tolerances for residues.

* * * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Mango.......................................................           8
 
                                * * * * *
Papaya......................................................           5
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2023-06457 Filed 3-28-23; 8:45 am]
BILLING CODE 6560-50-P