Azoxystrobin; Pesticide Tolerances, 16570-16573 [2023-05597]

Download as PDF 16570 Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Rules and Regulations TABLE 2 TO PARAGRAPH (d)—EPA-APPROVED GEORGIA SOURCE-SPECIFIC REQUIREMENTS—Continued Name of source Owens-Corning Fiberglass Corporation. * * * * 3296–060–10079 conditions 25 through 29 ................................... * I. General Information BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2021–0729; FRL–10603–01– OCSPP] Azoxystrobin; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: 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: RDFRNotices@epa.gov. lotter on DSK11XQN23PROD with RULES1 SUMMARY: 16:19 Mar 17, 2023 11/15/1994 SUPPLEMENTARY INFORMATION: [FR Doc. 2023–05241 Filed 3–17–23; 8:45 am] VerDate Sep<11>2014 State effective date Permit No. Jkt 259001 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 eCFR 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 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 EPA approval date Comments 3/18/1999, 64 FR 13348. 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-epadockets. 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-(2cyanophenoxy)pyrimidin-4yloxy]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. E:\FR\FM\20MRR1.SGM 20MRR1 lotter on DSK11XQN23PROD with RULES1 Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Rules and Regulations 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 VerDate Sep<11>2014 16:19 Mar 17, 2023 Jkt 259001 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 (nonoccupational) 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 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 16571 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-tomouth post-application exposure to children 1 to <2 years old from preserved vinyl flooring. EPA has concluded the combined short-term E:\FR\FM\20MRR1.SGM 20MRR1 16572 Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Rules and Regulations 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. lotter on DSK11XQN23PROD with RULES1 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 VerDate Sep<11>2014 16:19 Mar 17, 2023 Jkt 259001 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-(2cyanophenoxy)pyrimidin-4yloxy]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 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 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 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. E:\FR\FM\20MRR1.SGM 20MRR1 Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Rules and Regulations 2. In § 180.507, in paragraph (a)(1) amend the table by: ■ a. Adding a heading for the table; ■ b. Revising the entry for ‘‘Mango’’; ■ c. Adding in alphabetical order the entry ‘‘Palm, oil’’; ■ d. Revising the entry for ‘‘Papaya’’; and ■ e. Adding footnote 2 at the end of the table. The additions and revisions read as follows: lotter on DSK11XQN23PROD with RULES1 ■ I. Background and Discussion On June 16, 2022, the President signed the Ocean Shipping Reform Act of 2022 (‘‘OSRA 2022’’) into law,1 which amended various provisions of the Shipping Act.2 Section 8 of OSRA 2022 amended two Shipping Act provisions: 46 U.S.C. 41107 for monetary penalties or refunds; and 46 U.S.C. 41109 for assessment of penalties. Before OSRA 2022, section 41107 stated that any person that violates the § 180.507 Azoxystrobin; tolerances for Shipping Act or a regulation or order of residues. the Commission issued under the (a) * * * Shipping Act is liable for a civil penalty. (1) * * * OSRA 2022 changed the language in this section governing potential liability TABLE 1 TO PARAGRAPH (a)(1) of a violator by adding the phrase ‘‘or, in addition to or in lieu of a civil Parts per Commodity million penalty, is liable for the refund of a charge’’ immediately after the term civil penalty. Accordingly, the Commission * * * * * may now order that a person is liable for Mango ................................... 4 ‘‘a civil penalty or, in addition to or in lieu of a civil penalty, is liable for the * * * * * Palm, oil 2 .............................. 0.06 refund of a charge’’ for any violation of Papaya .................................. 6 the Shipping Act, Commission regulations, or Commission order. * * * * * As a result, the term ‘‘refund’’ now appears in two key provisions of the * * * * * * * 2 There are no U.S. registrations on palm, Shipping Act. First, in addition to appearing in sections 41107 and 41109 oil as of March 20, 2023. (as amended by OSRA 2022), the term * * * * * ‘‘refund’’ also appears in newly enacted [FR Doc. 2023–05597 Filed 3–17–23; 8:45 am] section 41310, which explicitly BILLING CODE 6560–50–P addresses the issue of charge complaints. That provision specifies, among other things, that upon a finding FEDERAL MARITIME COMMISSION by the Commission that a carrier’s charges do not comply with the 46 CFR Part 502 Shipping Act, the Commission shall [Docket No. FMC–2023–0008] promptly order the refund of those charges paid. See 46 U.S.C. 41310(c). RIN 3072–AC95 Second, the term ‘‘refund’’ appears in 46 U.S.C. 40503, which was not amended Civil Penalty Amendments to Rules of by OSRA 2022. This part of the Practice and Procedure Shipping Act addresses tariffs and AGENCY: Federal Maritime Commission. service contracts. Under section 40503, the Commission may permit a common ACTION: Final rule. carrier or a conference to refund a SUMMARY: The Federal Maritime portion of freight charges or to waive Commission (Commission) amends its collection of a portion of such charges Rules of Practice and Procedure from shippers for certain errors in tariffs governing the compromise, assessment, or tariff publications. The Commission’s mitigation, settlement, and collection of regulation at 46 CFR 502.271 (Special civil penalties. These changes to the docket application for permission to Commission regulations align with the refund or waive freight charges) statutory changes in the Ocean Shipping implements this tariff refund provision. Reform Act of 2022 on penalties or This provision, however, only applies to refunds. a refund or waiver of freight charges by a common carrier’s own application to DATES: The effective date is April 19, the Commission and does not include 2023. other types of charges. Further, the FOR FURTHER INFORMATION CONTACT: special docket application procedure William Cody, Secretary; Phone: (202) 523–5725; Email: secretary@fmc.gov. 1 Public Law 117–146. 2 46 U.S.C. 40101–41310. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 18:05 Mar 17, 2023 Jkt 259001 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 16573 does not provide for assessment of penalties. Therefore, when viewed against this backdrop, it is the Commission’s opinion that Congress amended section 41107, in part, to make it consistent with the Commission’s newly enacted authority to order a refund of charges paid under a charge complaint proceeding in section 10 of OSRA 2022, codified at 46 U.S.C. 41310. OSRA 2022 also made identical changes to 46 U.S.C. 41109. Section 41109 provides how to assess civil penalties and how to determine their amounts. Section 41109 as amended by OSRA 2022 states that the Commission may, after notice and opportunity for a hearing, ‘‘assess a civil penalty’’ or ‘‘in addition to, or in lieu of a civil penalty . . . order a refund of money.’’ 46 U.S.C. 41109(a)(1). OSRA 2022 also amended section 41109 by specifying the factors in determining ‘‘the amount of a civil penalty assessed or refund of money ordered.’’ 46 U.S.C. 41109(b)(1). While section 41109 now applies for assessment of penalties or refund, the Commission believes that section 41109’s revised factors are applicable only to assessment of penalties. OSRA 2022 also provided that if the Commission orders a refund of money in addition to a civil penalty, the amount of civil penalty must be decreased by any additional amounts included in the refund of money in excess of the ‘‘actual injury’’ as defined in the Shipping Act at 46 U.S.C. 41305(a). See 46 U.S.C. 41109(b)(2)(A). Therefore, the Commission makes conforming amendments to its regulations for civil penalties. The Commission is also making one technical change to update a term in 46 CFR 502.605(c). II. Rulemaking Analyses Administrative Procedure Act The Administrative Procedure Act (APA) requires that ‘‘[g]eneral notice of proposed rulemaking shall be published in the Federal Register, unless persons subject thereto are named and either personally served or otherwise have actual notice thereof in accordance with law.’’ 5 U.S.C. 553(b). The notice of proposed rulemaking requirement, however, does not apply to ‘‘interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.’’ 5 U.S.C. 553(b)(A). The notice requirement does not apply to this rule because it only amends the Commission’s rules of practice and procedure. Thus, the Commission issues this rule as a final rule. E:\FR\FM\20MRR1.SGM 20MRR1

Agencies

[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
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
 
                                * * * * *
------------------------------------------------------------------------
 * * * * * * *
\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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