Rule2023-05597
Azoxystrobin; 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 20, 2023
Effective
March 20, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of azoxystrobin in or on mango, papaya, and oil palm. 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 53 (Monday, March 20, 2023)</title>
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[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Rules and Regulations]
[Pages 16570-16573]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05597]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0729; FRL-10603-01-OCSPP]
Azoxystrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
azoxystrobin in or on mango, papaya, and oil palm. Syngenta Crop
Protection, LLC requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 20, 2023. Objections and
requests for hearings must be received on or before May 19, 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-2021-0729, 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. For the latest
status information on EPA/DC services, docket access, visit <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) 566-2875; email address:
<a href="/cdn-cgi/l/email-protection#ce9c8a889c80a1baa7adabbd8eabbeafe0a9a1b8"><span class="__cf_email__" data-cfemail="7f2d3b392d31100b161c1a0c3f1a0f1e51181009">[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 Office of the
Federal Register's e-CFR site at <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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 number EPA-HQ-OPP-2021-0729 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 19, 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-2021-0729, 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/send-comments-epa-dockets">https://www.epa.gov/send-comments-epa-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 May 20, 2022 (87 FR 30856) (FRL-9410-
13), 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
1F8946) by Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box
18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.507
be amended by establishing an import tolerance for residues of the
fungicide azoxystrobin, methyl (E)-2-[2-[6-(2-cyanophenoxy)pyrimidin-4-
yloxy]phenyl]-3-methoxyacrylate, in or on palm, oil at 0.06 parts per
million (ppm). The petition also requested to amend tolerances in 40
CFR 180.507 for residues of the fungicide azoxystrobin in or on mango
at 4 ppm and papaya at 6 ppm. The May 20, 2022, notice of filing
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.
[[Page 16571]]
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 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 azoxystrobin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with azoxystrobin 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 rulemakings of 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 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 tolerance rulemaking for
azoxystrobin, most recently on November 15, 2018, in which EPA
concluded, based on the available information, that there is a
reasonable certainty that no harm would result from aggregate exposure
to azoxystrobin and established tolerances for residues of that
pesticide chemical. EPA is incorporating previously published sections
from the 2018 rulemaking as described further in this rulemaking, as
they remain unchanged.
A. Toxicological Profile
For a discussion of the toxicological profile of azoxystrobin, see
Unit III.A. of the 2018 rulemaking (83 FR 57333) (FRL-9985-45).
B. Toxicological Points of Departure/Levels of Concern
For a summary of the toxicological points of departure/levels of
concern used for the safety assessment, see Unit III.B. of the 2018
rulemaking.
C. Exposure Assessment
Much of the exposure assessment remains the same, although updates
have occurred to accommodate exposures from the petitioned-for
tolerances. The updates are discussed in this section; for a
description of the rest of the EPA approach to and assumptions for the
exposure assessment, see Unit III.C. of the 2018 rulemaking.
Dietary exposure from food and feed uses. EPA's dietary exposure
assessments have been updated to include the increased exposure from
the amended tolerances of azoxystrobin on mango and papaya and the
additional exposure associated with the import tolerance on palm oil.
For the acute dietary exposure assessment, EPA used tolerance-level
residues for all commodities, except citrus fruits (which used the
highest residues from residue trials), 100 percent crop treated (PCT)
for all commodities, and default processing factors with the Dietary
Exposure Evaluation Model (DEEM) for all commodities except where
tolerances were established for processed commodities. For the chronic
dietary exposure assessment, EPA used tolerance-level residues for all
commodities, 100 PCT for all commodities, and default processing
factors with DEEM for all commodities except where tolerances were
established for processed commodities.
Anticipated residue and percent crop treated (PCT) information. EPA
did not use anticipated residue and/or PCT information in the dietary
assessment for azoxystrobin. Tolerance-level residues and/or 100 PCT
were assumed for all food commodities.
Drinking water, non-occupational, and cumulative exposures.
Drinking water exposures and residential (non-occupational) exposures
are not impacted by the amended uses and import tolerance in this
action. Since the last rulemaking in 2018, Registration Review was
completed for azoxystrobin, resulting in updated estimated drinking
water concentrations (EDWCs). The dietary risk assessment for this
petition used the updated surface water EDWCs of 69.4 ppb for acute
exposure and 20.7 ppb for chronic exposure, which were calculated with
the Surface Water Concentration Calculator (SWCC).
Azoxystrobin is currently registered for use on turf, ornamentals,
and antimicrobial uses as a materials preservative in paints and
plastics that could result in residential exposures. The residential
risk estimate that was used in the aggregate assessment is hand-to-
mouth incidental oral exposures to preserved vinyl flooring for
children aged 1 to less than 2 years old. EPA's conclusions concerning
cumulative risk remain unchanged from the 2018 rulemaking.
D. Safety Factor for Infants and Children
EPA continues to conclude that there is reliable data to support
the reduction of the Food Quality Protection Act (FQPA) safety factor
to 1X for all exposure scenarios except acute exposure. For assessing
acute dietary risk, EPA continues to retain an FQPA factor of 3X. See
Unit III.D. of the 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 PAD (aPAD) and chronic PAD (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.
Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are 29% of the aPAD for children 1 to 2 years old,
the population group receiving the greatest exposure. Chronic dietary
risks are below the Agency's level of concern of 100% of the cPAD; they
are 66% of the cPAD for children 1 to 2 years old, the population group
receiving the greatest exposure.
The Agency analyzed short-term aggregate risk by aggregating
chronic dietary (food and drinking water) exposure with incidental oral
hand-to-mouth post-application exposure to children 1 to <2 years old
from preserved vinyl flooring. EPA has concluded the combined short-
term
[[Page 16572]]
food, water, and residential exposures result in an aggregate MOE of
200 for children 1 to <2 years old. Because EPA's level of concern for
azoxystrobin is an MOE of less than 100; this MOE is not of concern.
As stated in Unit III. E. of the 2018 rulemaking, azoxystrobin is
not expected to pose an intermediate-term risk; therefore, the
intermediate-term aggregate risk would be equivalent to the chronic
dietary exposure estimate.
Based on the lack of evidence of carcinogenicity in two acceptable
rodent carcinogenicity studies, azoxystrobin is not expected to pose a
cancer risk to humans.
Therefore, based on these 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 azoxystrobin residues. More
detailed information can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the
document titled ``Azoxystrobin. Human Health Risk Assessment for the
Establishment of Tolerances for Residues in/on Mango and Papaya and
Establishment of a Tolerance for Residues in/on Imported Palm Oil.'' in
docket ID number EPA-HQ-OPP-2021-0729.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the 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 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.
The Codex has established MRLs for azoxystrobin in or on mango at
0.7 ppm and papaya at 0.3 ppm, which are lower than the current U.S.
tolerances for residues of azoxystrobin in or on mango at 2.0 ppm and
papaya at 2.0 ppm. The petitioner requested increasing the tolerance
for mango to 4 ppm and the tolerance for papaya to 6 ppm to support the
import of these commodities from other countries. The residue data
support the increased tolerances. Codex has not established an MRL for
residues of azoxystrobin in or on palm oil.
V. Conclusion
Therefore, an import tolerance is established for residues of
azoxystrobin, methyl (E)-2-[2-[6-(2-cyanophenoxy)pyrimidin-4-
yloxy]phenyl]-3-methoxyacrylate, in or on palm, oil at 0.06 ppm, and
existing tolerances are amended for azoxystrobin residues in or on
mango at 4 ppm and papaya at 6 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 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: March 14, 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 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.
[[Page 16573]]
0
2. In Sec. 180.507, in paragraph (a)(1) amend the table by:
0
a. Adding a heading for the table;
0
b. Revising the entry for ``Mango'';
0
c. Adding in alphabetical order the entry ``Palm, oil'';
0
d. Revising the entry for ``Papaya''; and
0
e. Adding footnote 2 at the end of the table.
The additions and revisions read as follows:
Sec. 180.507 Azoxystrobin; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Mango................................................... 4
* * * * *
Palm, oil \2\........................................... 0.06
Papaya.................................................. 6
* * * * *
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* * * * * * *
\2\ There are no U.S. registrations on palm, oil as of March 20, 2023.
* * * * *
[FR Doc. 2023-05597 Filed 3-17-23; 8:45 am]
BILLING CODE 6560-50-P
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