Rule2023-18182
Aspergillus flavus strain TC16F, TC35C, TC38B, and TC46G; Amendment to Temporary Exemptions From the Requirement of a Tolerance
Primary source
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Published
August 24, 2023
Effective
August 24, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 163 (Thursday, August 24, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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), <a href="https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf">https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf</a>. 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 <a href="https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf">https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf</a>.
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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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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