[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]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0334; FRL-8656-01-OCSPP]
Fludioxonil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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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].
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 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
20460-0001.
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
Bananas.''
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
commodities.
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:
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 table 1 to paragraph (a)(1) by adding in
alphabetical order the entry ``Banana'' and footnote 1 to read as
follows:
Sec. 180.516 Fludioxonil; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
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Parts per
Commodity million
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* * * * *
Banana\1\................................................... 3
* * * * *
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\1\ There are no U.S. registrations as of July 28, 2021.
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[FR Doc. 2021-16091 Filed 7-27-21; 8:45 am]
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