Aspergillus Flavus Strain AF36; Amendment to an Exemption From the Requirement of a Tolerance, 29541-29544 [2023-09732]

Download as PDF Federal Register / Vol. 88, No. 88 / Monday, May 8, 2023 / Rules and Regulations impact on the air quality of the affected area. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples. This action is subject to the Congressional Review Act, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 7, 2023. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. Authority: 42 U.S.C. 7401 et seq. [FR Doc. 2023–09058 Filed 5–5–23; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 Aspergillus Flavus Strain AF36; Amendment to an Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: For the reasons stated in the preamble, the EPA amends 40 CFR part 52 as follows: SUMMARY: 1. The authority citation for part 52 continues to read as follows: ■ Authority: 42 U.S.C. 7401 et seq. Subpart F—California 2. Section 52.220 is amended by revising paragraph (c)(591) introductory text and adding paragraph (c)(591)(ii) to read as follows: ■ § 52.220 Identification of plan—in part. * * * * * (c) * * * (591) The following rules and certifications were submitted on August 3, 2021, by the Governor’s designee, as VerDate Sep<11>2014 17:26 May 05, 2023 Jkt 259001 This regulation amends the existing tolerance exemption for residues of Aspergillus flavus strain AF36 by establishing an exemption for use on all food and feed commodities of cotton, corn, pistachio, almond, and fig when used in accordance with label directions and good agricultural practices. Interregional Research Project Number 4 (IR–4) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting to amend the existing tolerance exemption for Aspergillus flavus strain AF36. This regulation eliminates the need to establish a maximum permissible level for residues of Aspergillus flavus strain AF36 under FFDCA when used in accordance with the amended tolerance exemption. DATES: This regulation is effective May 8, 2023. Objections and requests for hearings must be received on or before July 7, 2023 and must be filed in PO 00000 Frm 00005 Fmt 4700 accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2022–0940, 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 20004. 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 OPP Docket is (202) 566–1744. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Frank Ellis, Biopesticides and Pollution Prevention Division (7511M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (202) 566– 1400; email address: BPPDFRNotices@ epa.gov. ADDRESSES: SUPPLEMENTARY INFORMATION: [EPA–HQ–OPP–2022–0940; FRL–10871–01– OCSPP] Dated: April 25, 2023. Martha Guzman Aceves, Regional Administrator, Region IX. PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS ddrumheller on DSK120RN23PROD with RULES1 an attachment to a letter dated August 3, 2021. * * * * * (ii) Additional materials. (A) San Joaquin Valley Unified Air Pollution Control District. (1) ‘‘Certification that the San Joaquin Valley Unified Air Pollution Control District’s Current Rules Address the Clean Air Act’s Clean Fuels for Boilers Requirements for the 2015 8-Hour Ozone Standard,’’ adopted on June 17, 2021. (2) [Reserved] (B) South Coast Air Quality Management District. (1) ‘‘Final Certification of Nonattainment New Source Review and Clean Fuels for Boilers Compliance Demonstration for 2015 8-hour Ozone Standard,’’ excluding the ‘‘Nonattainment New Source Review Compliance Demonstration,’’ adopted on June 4, 2021. (2) [Reserved] * * * * * 29541 Sfmt 4700 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 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(g), any person may file an E:\FR\FM\08MYR1.SGM 08MYR1 ddrumheller on DSK120RN23PROD with RULES1 29542 Federal Register / Vol. 88, No. 88 / Monday, May 8, 2023 / Rules and Regulations 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–2022–0940 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 July 7, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b), although EPA strongly encourages those interested in submitting objections or a hearing request to submit objections and hearing requests electronically. See Order Urging Electronic Service and Filing (April 10, 2020), https://www.epa.gov/ sites/default/files/2020-05/documents/ 2020-04-10_-_order_urging_electronic_ service_and_filing.pdf. At this time, because of the COVID–19 pandemic, the judges and staff of the Office of Administrative Law Judges are working remotely and not able to accept filings or correspondence by courier, personal delivery, or commercial delivery, and the ability to receive filings or correspondence by U.S. Mail is similarly limited. When submitting documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/ eab/eab-alj_upload.nsf. Although EPA’s regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions during this time that the Agency continues to maximize telework due to the pandemic; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. If it is impossible for a person to submit documents electronically or receive service electronically, e.g., the person does not have any access to a computer, the person shall so advise OALJ by contacting the Hearing Clerk at (202) 564–6281. If a person is without access to a computer and must file documents by U.S. Mail, the person shall notify the Hearing Clerk every time it files a document in such a manner. The address for mailing documents is U.S. Environmental Protection Agency, Office of Administrative Law Judges, Mail Code 1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please VerDate Sep<11>2014 17:26 May 05, 2023 Jkt 259001 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– 2022–0940, 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/dockets/where-sendcomments-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. Background In the Federal Register of January 3, 2023, (88 FR 38) (FRL–9410–08), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance exemption petition (PP 2E8988) by IR–4, North Carolina State University, 1730 Varsity Drive, Suite 210, Venture IV, Raleigh, NC 27606 on behalf of the Arizona Cotton Research and Protection Council, 3721 East Wier Avenue, Phoenix, AZ 85040. The petition requested that 40 CFR 180.1206 be amended to establish an amendment/ expansion of the existing tolerance exemption for the microbial pesticide Aspergillus flavus strain AF36 to include use on all food and feed commodities of cotton, corn, pistachio, almond, and fig. That document referenced a summary of the petition prepared by the petitioner IR–4 and available in the docket via https:// www.regulations.gov. EPA received no comments in response to the notice of filing. EPA changed the active ingredient name in the amended tolerance exemption expression from ‘‘Aspergillus flavus AF36’’ to ‘‘Aspergillus flavus strain AF36.’’ In addition, EPA consolidated the crops into one paragraph; condensed the list of cotton crops by changing the expression from PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 ‘‘cotton, gin byproducts; cotton, hulls; cotton, meal; cotton, refined oil; cotton, undelinted seed’’ to ‘‘all food and feed commodities of cotton’’; condensed the list of corn crops by changing the expression from ‘‘corn, field, forage; corn, field, grain; corn, field, stover; corn, field, aspirated grain fractions; corn, sweet, kernel plus cob with husk removed; corn, sweet, forage; corn, sweet, stover; corn, pop, grain; and corn, pop, stover’’ to ‘‘[all food and feed commodities of] corn, field; corn, sweet; corn, pop’’; and removed the stipulation ‘‘when applied/used as an antifungal agent.’’ EPA is also revoking the section 18 emergency exemption for residues of Aspergillus flavus strain AF36 in or on dried figs that expired on December 31, 2017. The reasons for these changes are explained in Unit III.C. III. Final Rule A. EPA’s Safety Determination Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ‘‘safe.’’ Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption 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. . . .’’ Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider ‘‘available information concerning the cumulative effects of [a particular pesticide’s] . . . residues and other substances that have a common mechanism of toxicity.’’ EPA evaluated the available toxicological and exposure data on Aspergillus flavus strain AF36 and considered their validity, completeness, and reliability, as well as the relationship of this information to E:\FR\FM\08MYR1.SGM 08MYR1 ddrumheller on DSK120RN23PROD with RULES1 Federal Register / Vol. 88, No. 88 / Monday, May 8, 2023 / Rules and Regulations human risk. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the documents entitled ‘‘Comprehensive Science Review: New Food Uses for a New End Use Product (EP) Aspergillus flavus AF36 Prime (71693–G) containing an unregistered source of the active ingredient Aspergillus flavus strain AF36 and a petition to amend an existing tolerance exemption (40 CFR 180.1206) to include all food and feed commodities of any included crops’’ (Human Health Risk Assessment for New Food Use of Aspergillus flavus strain AF36) and ‘‘Addendum to Comprehensive Science Review: New Food Uses for a New End Use Product (EP) Aspergillus flavus AF36 Prime (71693–G) containing an unregistered source of the active ingredient Aspergillus flavus strain AF36 and a petition to amend an existing tolerance exemption (40 CFR 180.1206) to include all food and feed commodities of any included crops.’’ These documents, as well as other relevant information, are available in the docket for this action as described under ADDRESSES. The toxicological profile of Aspergillus flavus strain AF36 was previously described in the ‘‘Biopesticides Registration Action Document Aspergillus flavus AF36,’’ available in docket EPA–HQ–OPP– 2003–0323, and ‘‘Aspergillus flavus Interim Registration Review Decision Case Number 6008,’’ available in docket EPA–HQ–OPP–2015–0281. The toxicological profile remains unchanged, and the available data demonstrated that, with regard to humans, Aspergillus flavus strain AF36 is not toxic, pathogenic, or infective via the oral or inhalation routes. The data requirement for acute intravenous toxicity/pathogenicity was met with scientific rationale based on acute oral toxicity and acute pulmonary toxicity/ pathogenicity data, which indicated that test animals’ immune systems were intact and able to process and clear Aspergillus flavus strain AF36. Although there is potential for dietary and non-occupational exposure to residues of Aspergillus flavus strain AF36, there is not a concern due to the lack of potential for adverse effects. Because there are no threshold levels of concern with the toxicity, pathogenicity, or infectivity of Aspergillus flavus strain AF36, EPA determined that no additional margin of safety is necessary to protect infants and children as part of the qualitative assessment conducted. Based upon its evaluation in the Human Health Risk Assessment for New Food Use of Aspergillus flavus strain VerDate Sep<11>2014 17:26 May 05, 2023 Jkt 259001 AF36, which concludes that there are no risks of concern from aggregate exposure to Aspergillus flavus strain AF36, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Aspergillus flavus strain AF36. B. Analytical Enforcement Methodology An analytical method is not required for Aspergillus flavus strain AF36 because EPA is amending an exemption from the requirement of a tolerance without any numerical limitation. C. Revisions to the Requested Amendment to a Tolerance Exemption Four non-substantive modifications were made to the requested tolerance exemption that do not impact the safety finding for Aspergillus flavus strain AF36. EPA changed the active ingredient name from ‘‘Aspergillus flavus AF36’’ to ‘‘Aspergillus flavus strain AF36’’ to align with current active ingredient naming conventions. EPA consolidated the crops into one paragraph that includes ‘‘all food and feed commodities of almond; corn, field; corn, pop; corn, sweet; cotton; fig; and pistachio’’ because the requested amendment to the tolerance exemption proposes to add ‘‘all food and feed commodities’’ for each crop in the tolerance exemption. The Agency’s change creates a more concise list that covers all crops petitioned for by the petitioner and aligns with the Agency’s food and feed commodity vocabulary. EPA removed the stipulation for the exemption from the requirement of a tolerance for residues of Aspergillus flavus strain AF36 ‘‘when applied as an antifungal agent,’’ as the specification ‘‘when used in accordance with label directions and good agricultural practices’’ adequately addresses the Agency’s safety concerns with the application methods. As a housekeeping matter, EPA also removed the section 18 emergency exemption for residues of Aspergillus flavus strain AF36 in or on dried figs because it expired on December 31, 2017. D. Conclusion Therefore, the existing Aspergillus flavus strain AF36 tolerance exemption is amended by establishing a tolerance exemption for residues of the microbial pesticide Aspergillus flavus strain AF36 in or on all food and feed commodities of almond; corn, field; corn, pop; corn, sweet; cotton; fig; and pistachio when used in accordance with label directions and good agricultural practices. PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 29543 IV. Statutory and Executive Order Reviews This action amends a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. 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, 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 amended on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 E:\FR\FM\08MYR1.SGM 08MYR1 29544 Federal Register / Vol. 88, No. 88 / Monday, May 8, 2023 / Rules and Regulations Mandates Reform Act (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require EPA’s consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (15 U.S.C. 272 note). V. 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). 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Revise § 180.1206 to read as follows: ■ Dated: April 28, 2023. Frank Ellis, Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: FEDERAL COMMUNICATIONS COMMISSION Effective May 8, 2023. FOR FURTHER INFORMATION CONTACT: Roland Helvajian, Office of Managing Director, at (202) 418–0444. An exemption from the requirement of a tolerance is established for residues of the microbial pesticide Aspergillus flavus strain AF36 in or on all food and feed commodities of almond; corn, field; corn, pop; corn, sweet; cotton; fig; and pistachio when used in accordance with label directions and good agricultural practices. BILLING CODE 6560–50–P Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. DATES: § 180.1206 Aspergillus flavus strain AF36; exemption from the requirement of a tolerance. [FR Doc. 2023–09732 Filed 5–5–23; 8:45 am] List of Subjects in 40 CFR Part 180 (Commission) revised the Commission’s rules. That document had two clerical errors in the fee amounts for two types of Commercial AM Radio Stations applications: Minor Modification, Construction Permit and New License. This document is submitted to correct the final regulations. PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD This is a summary of the FCC’s Erratum, FCC 22– 94, published January 31, 2023 (88 FR 6169). This is the first set of corrections. SUPPLEMENTARY INFORMATION: List of Subjects in 47 CFR Part 1 Administrative practices and procedures. Accordingly, 47 CFR part 1 is corrected by making the following correcting amendments: PART 1—PRACTICE AND PROCEDURE 1. The authority citation for part 1 continues to read as follows: ■ 47 CFR Part 1 [MD Docket No. 20–270; FCC 22–94; FR ID 139226] Schedule of Application Fees; Correction Federal Communications Commission. ACTION: Correcting amendments. AGENCY: On January 31, 2023, the Federal Communications Commission SUMMARY: Authority: 47 U.S.C. chs. 2, 5, 9, 13; 28 U.S.C. 2461 note, unless otherwise noted. 2. In § 1.1104, revise Table 2, Commercial AM radio stations, to read as follows: ■ § 1.1104 Schedule of charges for applications and other filings for media services. * * * * * TABLE 2 TO § 1.1104 ddrumheller on DSK120RN23PROD with RULES1 Commercial AM radio stations Type of application Payment type code New or Major Change, Construction Permit ................................................... New or Major Change, Construction Permit ................................................... Minor Modification, Construction Permit .......................................................... New License .................................................................................................... AM Directional Antenna ................................................................................... License Renewal ............................................................................................. License Assignment (2100 Schedule 314 & 159 (long form) ......................... License Assignment (2100 Schedule 316 & 159 (short form) ........................ Transfer of Control (2100 Schedule 315 & 159 (long form) ........................... Transfer of Control (2100 Schedule 316 & 159 (short form) .......................... Call Sign .......................................................................................................... Special Temporary Authority ........................................................................... Biennial Ownership Report .............................................................................. MUR .............. MVR ............... MVU ............... MMR .............. MOR .............. MGR .............. MPR ............... MDR .............. MPR ............... MDR .............. MBR ............... MVV ............... MAR ............... VerDate Sep<11>2014 17:26 May 05, 2023 Jkt 259001 PO 00000 Frm 00008 Fmt 4700 Sfmt 9990 Fee amount $4,440/application. $5,085/application. $1,815/application. $720/application. $1,405/application. $365/application. $1,120/station. $475/station. $1,120/station. $475/station. $190/application. $325/application. $95/station. E:\FR\FM\08MYR1.SGM 08MYR1

Agencies

[Federal Register Volume 88, Number 88 (Monday, May 8, 2023)]
[Rules and Regulations]
[Pages 29541-29544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09732]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0940; FRL-10871-01-OCSPP]


Aspergillus Flavus Strain AF36; Amendment to an Exemption From 
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation amends the existing tolerance exemption for 
residues of Aspergillus flavus strain AF36 by establishing an exemption 
for use on all food and feed commodities of cotton, corn, pistachio, 
almond, and fig when used in accordance with label directions and good 
agricultural practices. Interregional Research Project Number 4 (IR-4) 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting to amend the existing tolerance exemption for 
Aspergillus flavus strain AF36. This regulation eliminates the need to 
establish a maximum permissible level for residues of Aspergillus 
flavus strain AF36 under FFDCA when used in accordance with the amended 
tolerance exemption.

DATES: This regulation is effective May 8, 2023. Objections and 
requests for hearings must be received on or before July 7, 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-2022-0940, 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 20004. 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 OPP Docket is (202) 566-1744. Please review the 
visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Frank Ellis, Biopesticides and 
Pollution Prevention Division (7511M), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (202) 566-1400; 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 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(g), any person may file 
an

[[Page 29542]]

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-2022-0940 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 
July 7, 2023. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b), although EPA 
strongly encourages those interested in submitting objections or a 
hearing request to submit objections and hearing requests 
electronically. See Order Urging Electronic Service and Filing (April 
10, 2020), https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf. At this 
time, because of the COVID-19 pandemic, the judges and staff of the 
Office of Administrative Law Judges are working remotely and not able 
to accept filings or correspondence by courier, personal delivery, or 
commercial delivery, and the ability to receive filings or 
correspondence by U.S. Mail is similarly limited. When submitting 
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a 
person should utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.
    Although EPA's regulations require submission via U.S. Mail or hand 
delivery, EPA intends to treat submissions filed via electronic means 
as properly filed submissions during this time that the Agency 
continues to maximize telework due to the pandemic; therefore, EPA 
believes the preference for submission via electronic means will not be 
prejudicial. If it is impossible for a person to submit documents 
electronically or receive service electronically, e.g., the person does 
not have any access to a computer, the person shall so advise OALJ by 
contacting the Hearing Clerk at (202) 564-6281. If a person is without 
access to a computer and must file documents by U.S. Mail, the person 
shall notify the Hearing Clerk every time it files a document in such a 
manner. The address for mailing documents is U.S. Environmental 
Protection Agency, Office of Administrative Law Judges, Mail Code 
1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    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-2022-0940, 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/dockets/where-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. Background

    In the Federal Register of January 3, 2023, (88 FR 38) (FRL-9410-
08), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
exemption petition (PP 2E8988) by IR-4, North Carolina State 
University, 1730 Varsity Drive, Suite 210, Venture IV, Raleigh, NC 
27606 on behalf of the Arizona Cotton Research and Protection Council, 
3721 East Wier Avenue, Phoenix, AZ 85040. The petition requested that 
40 CFR 180.1206 be amended to establish an amendment/expansion of the 
existing tolerance exemption for the microbial pesticide Aspergillus 
flavus strain AF36 to include use on all food and feed commodities of 
cotton, corn, pistachio, almond, and fig. That document referenced a 
summary of the petition prepared by the petitioner IR-4 and available 
in the docket via https://www.regulations.gov. EPA received no comments 
in response to the notice of filing.
    EPA changed the active ingredient name in the amended tolerance 
exemption expression from ``Aspergillus flavus AF36'' to ``Aspergillus 
flavus strain AF36.'' In addition, EPA consolidated the crops into one 
paragraph; condensed the list of cotton crops by changing the 
expression from ``cotton, gin byproducts; cotton, hulls; cotton, meal; 
cotton, refined oil; cotton, undelinted seed'' to ``all food and feed 
commodities of cotton''; condensed the list of corn crops by changing 
the expression from ``corn, field, forage; corn, field, grain; corn, 
field, stover; corn, field, aspirated grain fractions; corn, sweet, 
kernel plus cob with husk removed; corn, sweet, forage; corn, sweet, 
stover; corn, pop, grain; and corn, pop, stover'' to ``[all food and 
feed commodities of] corn, field; corn, sweet; corn, pop''; and removed 
the stipulation ``when applied/used as an antifungal agent.'' EPA is 
also revoking the section 18 emergency exemption for residues of 
Aspergillus flavus strain AF36 in or on dried figs that expired on 
December 31, 2017. The reasons for these changes are explained in Unit 
III.C.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance or tolerance exemption 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. . . .'' Additionally, FFDCA section 408(b)(2)(D) 
requires that EPA consider ``available information concerning the 
cumulative effects of [a particular pesticide's] . . . residues and 
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicological and exposure data on 
Aspergillus flavus strain AF36 and considered their validity, 
completeness, and reliability, as well as the relationship of this 
information to

[[Page 29543]]

human risk. A full explanation of the data upon which EPA relied and 
its risk assessment based on those data can be found within the 
documents entitled ``Comprehensive Science Review: New Food Uses for a 
New End Use Product (EP) Aspergillus flavus AF36 Prime (71693-G) 
containing an unregistered source of the active ingredient Aspergillus 
flavus strain AF36 and a petition to amend an existing tolerance 
exemption (40 CFR 180.1206) to include all food and feed commodities of 
any included crops'' (Human Health Risk Assessment for New Food Use of 
Aspergillus flavus strain AF36) and ``Addendum to Comprehensive Science 
Review: New Food Uses for a New End Use Product (EP) Aspergillus flavus 
AF36 Prime (71693-G) containing an unregistered source of the active 
ingredient Aspergillus flavus strain AF36 and a petition to amend an 
existing tolerance exemption (40 CFR 180.1206) to include all food and 
feed commodities of any included crops.'' These documents, as well as 
other relevant information, are available in the docket for this action 
as described under ADDRESSES.
    The toxicological profile of Aspergillus flavus strain AF36 was 
previously described in the ``Biopesticides Registration Action 
Document Aspergillus flavus AF36,'' available in docket EPA-HQ-OPP-
2003-0323, and ``Aspergillus flavus Interim Registration Review 
Decision Case Number 6008,'' available in docket EPA-HQ-OPP-2015-0281. 
The toxicological profile remains unchanged, and the available data 
demonstrated that, with regard to humans, Aspergillus flavus strain 
AF36 is not toxic, pathogenic, or infective via the oral or inhalation 
routes. The data requirement for acute intravenous toxicity/
pathogenicity was met with scientific rationale based on acute oral 
toxicity and acute pulmonary toxicity/pathogenicity data, which 
indicated that test animals' immune systems were intact and able to 
process and clear Aspergillus flavus strain AF36. Although there is 
potential for dietary and non-occupational exposure to residues of 
Aspergillus flavus strain AF36, there is not a concern due to the lack 
of potential for adverse effects. Because there are no threshold levels 
of concern with the toxicity, pathogenicity, or infectivity of 
Aspergillus flavus strain AF36, EPA determined that no additional 
margin of safety is necessary to protect infants and children as part 
of the qualitative assessment conducted.
    Based upon its evaluation in the Human Health Risk Assessment for 
New Food Use of Aspergillus flavus strain AF36, which concludes that 
there are no risks of concern from aggregate exposure to Aspergillus 
flavus strain AF36, EPA concludes that there is a reasonable certainty 
that no harm will result to the U.S. population, including infants and 
children, from aggregate exposure to residues of Aspergillus flavus 
strain AF36.

B. Analytical Enforcement Methodology

    An analytical method is not required for Aspergillus flavus strain 
AF36 because EPA is amending an exemption from the requirement of a 
tolerance without any numerical limitation.

C. Revisions to the Requested Amendment to a Tolerance Exemption

    Four non-substantive modifications were made to the requested 
tolerance exemption that do not impact the safety finding for 
Aspergillus flavus strain AF36. EPA changed the active ingredient name 
from ``Aspergillus flavus AF36'' to ``Aspergillus flavus strain AF36'' 
to align with current active ingredient naming conventions. EPA 
consolidated the crops into one paragraph that includes ``all food and 
feed commodities of almond; corn, field; corn, pop; corn, sweet; 
cotton; fig; and pistachio'' because the requested amendment to the 
tolerance exemption proposes to add ``all food and feed commodities'' 
for each crop in the tolerance exemption. The Agency's change creates a 
more concise list that covers all crops petitioned for by the 
petitioner and aligns with the Agency's food and feed commodity 
vocabulary. EPA removed the stipulation for the exemption from the 
requirement of a tolerance for residues of Aspergillus flavus strain 
AF36 ``when applied as an antifungal agent,'' as the specification 
``when used in accordance with label directions and good agricultural 
practices'' adequately addresses the Agency's safety concerns with the 
application methods. As a housekeeping matter, EPA also removed the 
section 18 emergency exemption for residues of Aspergillus flavus 
strain AF36 in or on dried figs because it expired on December 31, 
2017.

D. Conclusion

    Therefore, the existing Aspergillus flavus strain AF36 tolerance 
exemption is amended by establishing a tolerance exemption for residues 
of the microbial pesticide Aspergillus flavus strain AF36 in or on all 
food and feed commodities of almond; corn, field; corn, pop; corn, 
sweet; cotton; fig; and pistachio when used in accordance with label 
directions and good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action amends a tolerance exemption under FFDCA section 408(d) 
in response to a petition submitted to EPA. 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, 
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 amended on the basis of a 
petition under FFDCA section 408(d), such as the tolerance exemption in 
this action, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA 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, EPA 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

[[Page 29544]]

Mandates Reform Act (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require EPA's consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (15 U.S.C. 272 note).

V. 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: April 28, 2023.
Frank Ellis,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Revise Sec.  180.1206 to read as follows:


Sec.  180.1206  Aspergillus flavus strain AF36; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Aspergillus flavus strain AF36 in 
or on all food and feed commodities of almond; corn, field; corn, pop; 
corn, sweet; cotton; fig; and pistachio when used in accordance with 
label directions and good agricultural practices.

[FR Doc. 2023-09732 Filed 5-5-23; 8:45 am]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.