Rule2023-09732
Aspergillus Flavus Strain AF36; Amendment to an Exemption From the Requirement of a Tolerance
Primary source
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Published
May 8, 2023
Effective
May 8, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 88 (Monday, May 8, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<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. Please review the
visitor instructions and additional information about the docket
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#7e3c2e2e3a382c30110a171d1b0d3e1b0e1f50191108"><span class="__cf_email__" data-cfemail="044654544042564a6b706d676177446174652a636b72">[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).
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
[[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), <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-2022-0940, 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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
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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
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