[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 [www.gpo.gov]
[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 
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. For the latest 
status information on EPA/DC services, docket access, visit 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) 566-2875; 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 Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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:
     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/send-comments-epa-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 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, 
https://www.regulations.gov. 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 https://www.regulations.gov 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
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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
 
                                * * * * *
------------------------------------------------------------------------
 * * * * * * *
\2\ There are no U.S. registrations on palm, oil as of March 20, 2023.

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[FR Doc. 2023-05597 Filed 3-17-23; 8:45 am]
BILLING CODE 6560-50-P