[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Rules and Regulations]
[Pages 40338-40340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16091]



40 CFR Part 180

[EPA-HQ-OPP-2020-0334; FRL-8656-01-OCSPP]

Fludioxonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes a tolerance for residues of 
fludioxonil in or on banana. Syngenta Crop Protection, LLC requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 28, 2021. Objections and 
requests for hearings must be received on or before September 27, 2021, 
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-2020-0334, is available at http://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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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].


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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2020-0334 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 
September 27, 2021. 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-

[[Page 40339]]

2020-0334, by one of the following methods:
     Federal eRulemaking Portal: http://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 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 22, 2021 (86 FR 21317) (FRL-10022-
59), 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 
9E8798) by Syngenta Crop Protection, LLC, 410 Swing Road, NC 27419-
8300. The petition requested that 40 CFR 180.516 be amended by 
establishing a tolerance for residues of the fungicide fludioxonil, 4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, in or on 
banana at 2.0 parts per million (ppm). That document referenced a 
summary of the petition prepared by Syngenta Crop Protection, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    FFDCA section 408(d)(4)(A)(i) permits the Agency to finalize a 
tolerance that varies from that sought by the petition. Based upon 
review of the data supporting the petition, EPA is modifying the 
requested tolerance based on crop field trial data and for consistency 
with the Organization for Economic Co-Operation and Development (OECD) 
tolerance-rounding class practice. The reason for these changes are 
explained in Unit IV.D.

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 tolerance established by this action. EPA's assessment of exposures 
and risks associated with fludioxonil follows.
    In an effort to streamline Federal Register publications, EPA is 
not reprinting here summaries of its analyses that have previously 
appeared in the Federal Register in previous tolerance rulemakings for 
the same pesticide. To that end, this rulemaking refers the reader to 
several sections from the November 6, 2018 tolerance rulemaking for 
residues of fludioxonil that remain unchanged for an understanding of 
the Agency's rationale in support of this rulemaking. See 83 FR 55491 
(FRL-9982-75). Those sections are: Units III.A. (Toxicological 
Profile); III.B. (Toxicological Points of Departure/Levels of Concern); 
III.C. (Exposure Assessment), except as explained in the next 
paragraphs; and III.D. (Safety Factor for Infants and Children). 
Further information about the Agency's risk assessment and 
determination of safety supporting the new tolerance for residues of 
fludioxonil on bananas can be found in docket ID number EPA-HQ-OPP-
2020-0334 in the document titled ``Fludioxonil. Human Health Risk 
Assessment for the Establishment of a Permanent Tolerance on Imported 
    Updates to exposure assessments. EPA's dietary (food and drinking 
water) exposure assessments have been updated to include the additional 
exposure from use of fludioxonil on bananas, and relied on tolerance-
level residues, an assumption of 100 percent crop treated (PCT), and 
2018 default processing factors for all processed commodities. EPA's 
aggregate exposure assessment incorporated this additional dietary 
exposure. Drinking water exposures are not impacted by the new use on 
banana, and thus have not changed since the last assessment.
    Assessment of aggregate risks. An acute aggregate risk assessment 
was not conducted since effects attributable to a single exposure were 
not identified. Short-term aggregate risk for adults and children 
resulted in margins of exposure >= 280, which is above the level of 
concern of 100 and not of concern. An intermediate-term aggregate risk 
assessment was not conducted since exposures are not expected based on 
the use pattern. The chronic aggregate risk assessment was equivalent 
to the chronic dietary risk assessment and was not conducted since 
there are no long-term exposures expected based on the use pattern. 
Chronic aggregate risks consist of dietary (food and drinking water) 
exposure only and are below the Agency's level of concern: 56% of the 
chronic population adjusted dose (cPAD) for children 1 to 2 years old, 
the group with the highest exposure.
    Determination of safety. 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 the subject action to establish a 
tolerance in or on bananas can be found in the document entitled, 
``Fludioxonil. Human Health Risk Assessment for the Establishment of a 
Permanent Tolerance on Imported Bananas'' by going to http://www.regulations.gov. The referenced document is available in the docket 
established by this action, EPA-HQ-OPP-2020-0334.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography/ultraviolet (HPLC/UV) methods (Methods AG-597 and AG-
597B)) is available for enforcing tolerances for fludioxonil on plant 
commodities. An adequate liquid chromatography, tandem mass 
spectrometry (LC-MS/MS) method (Analytical Method GRM025.03A) is 
available for enforcing tolerances for fludioxonil on livestock 
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905;

[[Page 40340]]

email address: [email protected].

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 Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. 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 not established a MRL for fludioxonil; however, 
Canada's Pest Management Regulatory Agency (PMRA) has a default MRL of 
0.1 ppm on banana. EPA is establishing a tolerance level for bananas at 
3 ppm.

C. Revisions to Petitioned-For Tolerances

    The petitioned-for tolerance level of 2.0 ppm in bananas has been 
modified to 3 ppm based on crop field trial data and the OECD tolerance 
calculation procedure.

V. Conclusion

    Therefore, a tolerance is established for residues of fludioxonil, 
4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, in or 
on banana at 3 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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 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: July 15, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:


1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

2. In Sec.  180.516, amend table 1 to paragraph (a)(1) by adding in 
alphabetical order the entry ``Banana'' and footnote 1 to read as 

Sec.  180.516  Fludioxonil; tolerances for residues.

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

                       Table 1 to Paragraph (a)(1)
                                                               Parts per
                          Commodity                             million
                                * * * * *
Banana\1\...................................................           3
                               * * * * *
\1\ There are no U.S. registrations as of July 28, 2021.

* * * * *
[FR Doc. 2021-16091 Filed 7-27-21; 8:45 am]