Rule2023-06457
Fludioxonil; Pesticide Tolerances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 29, 2023
Effective
March 29, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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).
Full Text
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<title>Federal Register, Volume 88 Issue 60 (Wednesday, March 29, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#65372123372b0a110c060016250015044b020a13"><span class="__cf_email__" data-cfemail="96c4d2d0c4d8f9e2fff5f3e5d6f3e6f7b8f1f9e0">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 <a href="https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1">https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
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* * * * *
Mango....................................................... 8
* * * * *
Papaya...................................................... 5
* * * * *
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[FR Doc. 2023-06457 Filed 3-28-23; 8:45 am]
BILLING CODE 6560-50-P
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