[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]


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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.

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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

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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