[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Rules and Regulations]
[Pages 57898-57901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18182]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0797; FRL-10971-01-OCSPP]


Aspergillus flavus strain TC16F, TC35C, TC38B, and TC46G; 
Amendment to Temporary Exemptions From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the existing temporary tolerance 
exemptions for residues of Aspergillus flavus strains TC16F, TC35C, 
TC38B, and TC46G by establishing permanent tolerance exemptions for use 
in or on all food and feed commodities of field corn, popcorn, and 
sweet corn. 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 temporary tolerance exemptions for 
Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and 
TC46G under FFDCA when used in accordance with label directions and 
good agricultural practices.

DATES: This regulation is effective August 24, 2023. Objections and 
requests for hearings must be received on or before October 23, 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-2022-0797, 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. For the latest status 
information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Madison Le, 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: 
<a href="/cdn-cgi/l/email-protection#652735352123372b0a110c060016250015044b020a13"><span class="__cf_email__" data-cfemail="a6e4f6f6e2e0f4e8c9d2cfc5c3d5e6c3d6c788c1c9d0">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).

[[Page 57899]]

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 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-2022-0797 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 
October 23, 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-2022-0797, by one of 
the following methods:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
    <bullet> Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at 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 February 23, 2023 (88 FR 11401) (FRL-
10579-01), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
exemption petition (PP 1E8975) by IR-4, North Carolina State 
University, 1730 Varsity Drive, Suite 210, Venture IV, Raleigh, NC 
27606, on behalf of the Texas Corn Producers Board, 4205 N Interstate 
27, Lubbock, Texas 79403. The petition requested that 40 CFR 180.1338 
be amended to establish an amendment of the existing temporary 
tolerance exemptions for the microbial pesticides Aspergillus flavus 
strains TC16F, TC35C, TC38B, and TC46G in or on all food and feed 
commodities of field corn, popcorn, and sweet corn. That notice 
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 modified language from the requested tolerance exemption and 
changed ``exemption'' to ``exemptions'' in the amended tolerance 
exemption expression. The reason for this change is 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 strains TC16F, TC35C, TC38B, and TC46G and 
considered their validity, completeness, and reliability, as well as 
the relationship of this information to 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 document entitled ``Human Health 
Risk Assessment of Aspergillus flavus strain TC16F, Aspergillus flavus 
strain TC35C, Aspergillus flavus strain TC38B, and Aspergillus flavus 
strain TC46G, New Active Ingredients, in FourSure

[[Page 57900]]

Proposed for Registration and an Associated Petition Requesting a 
Tolerance Exemption'' (Human Health Risk Assessment of Aspergillus 
flavus strains TC16F, TC35C, TC38B, and TC46G). This document, as well 
as other relevant information, is available in the docket for this 
action as described under ADDRESSES.
    The toxicological profiles of Aspergillus flavus strains TC16F, 
TC35C, TC38B, and TC46G were previously described in the ``Review of 
Product Identity, Human Health Data, and Petition for a Temporary 
Tolerance Exemption for the IR-4 and Texas Corn Producers Board 
FourSure Experimental Use Permit 5E8397,'' available in docket EPA-HQ-
OPP-2015-0742 and remain unchanged at this time. Based upon its 
evaluation, EPA concludes that, with regard to humans, Aspergillus 
flavus strains TC16F, TC35C, TC38B, and TC46G are not anticipated to be 
toxic, pathogenic, or infective via any reasonably foreseeable route of 
exposure. Although there is potential for dietary and non-occupational 
exposure to residues of Aspergillus flavus strains TC16F, TC35C, TC38B, 
and TC46G, 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 
strains TC16F, TC35C, TC38B, and TC46G, 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 of 
Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G, which 
concludes that there are no risks of concern from aggregate exposure to 
Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G, 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 strains TC16F, TC35C, TC38B, 
and TC46G.

B. Analytical Enforcement Methodology

    An analytical method is not required for Aspergillus flavus strains 
TC16F, TC35C, TC38B, and TC46G because EPA is amending temporary 
exemptions from the requirement of a tolerance without any numerical 
limitations.

C. Revisions to the Requested Amendment to a Tolerance Exemption

    One modification was made to the requested tolerance exemption. EPA 
changed ``exemption'' to ``exemptions'' as four different active 
ingredients are covered with this action.

D. Conclusion

    Therefore, the existing Aspergillus flavus strains TC16F, TC35C, 
TC38B, and TC46G temporary tolerance exemptions are amended by 
establishing permanent tolerance exemptions for residues of Aspergillus 
flavus strains TC16F, TC35C, TC38B, and TC46G in or on all food and 
feed commodities of corn, field; corn, pop; and corn, sweet when used 
in accordance with label directions and good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action amends temporary tolerance exemptions 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 exemptions 
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 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: August 16, 2023.
Edward Messina,
Director, 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.  180.1338 to read as follows:


Sec.  180.1338   Aspergillus flavus strains TC16F, TC35C, TC38B, and 
TC46G; exemptions from the requirement of a tolerance.

    Exemptions from the requirement of a tolerance are established for 
residues of

[[Page 57901]]

Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on all 
food and feed commodities of corn, field; corn, pop; and corn, sweet 
when used in accordance with label directions and good agricultural 
practices.

[FR Doc. 2023-18182 Filed 8-23-23; 8:45 am]
BILLING CODE 6560-50-P


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