Rule2024-02787
U1-AGTX-Ta1b-QA Protein; Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 12, 2024
Effective
February 12, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of the U1-AGTX-Ta1b-QA protein in or on all food commodities when used in accordance with label directions and good agricultural practices. Vestaron Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance for residues of the U1-AGTX-Ta1b-QA protein in and on all food commodities. This regulation eliminates the need to establish a maximum permissible level for residues of U1-AGTX-Ta1b-QA protein under FFDCA when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 89 Issue 29 (Monday, February 12, 2024)</title>
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[Federal Register Volume 89, Number 29 (Monday, February 12, 2024)]
[Rules and Regulations]
[Pages 9773-9776]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02787]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0781; FRL-11563-01-OCSPP]
U1-AGTX-Ta1b-QA Protein; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the U1-AGTX-Ta1b-QA protein in or on all
food commodities when used in accordance with label directions and good
agricultural practices. Vestaron Corporation submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
an exemption from the requirement of a tolerance for residues of the
U1-AGTX-Ta1b-QA protein in and on all food commodities. This regulation
eliminates the need to establish a maximum permissible level for
residues of U1-AGTX-Ta1b-QA protein under FFDCA when used in accordance
with this exemption.
DATES: This regulation is effective February 12, 2024. Objections and
requests for hearings must be received on or before April 12, 2024, 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-2021-0781, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: 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#397b69697d7f6b77564d505a5c4a795c4958175e564f"><span class="__cf_email__" data-cfemail="a0e2f0f0e4e6f2eecfd4c9c3c5d3e0c5d0c18ec7cfd6">[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
[[Page 9774]]
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 Federal Register Office's e-CFR site at <a href="https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1">https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2021-0781 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
April 12, 2024. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
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-2021-0781, 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 and Statutory Findings
In the Federal Register of March 22, 2022 (87 FR 16133) (FRL-9410-
11-OCSPP), 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
petition (PP 1F8923) by Vestaron Corporation, 600 Park Offices Dr.,
Suite 117, Research Triangle Park, NC 27709. The petition requested
that 40 CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for residues of U1-AGTX-Ta1b-QA protein.
That document referenced a summary of the petition prepared by the
petitioner Vestaron Corporation, which is available in the docket,
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. EPA received one comment on the notice of
filing. EPA's response to this comment is discussed in Unit VII.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 for 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 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 the Agency
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 U1-
AGTX-Ta1b-QA protein 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 in Support of the Registration
of `Basin' End Use Product Containing the New Active Ingredient U1-
AGTX-Ta1b-QA (8.5%) and Associated Petition to Establish a Permanent
Tolerance Exemption'' (Human Health Risk Assessment). This document, as
well as other relevant information, is available in the docket for this
action as described under ADDRESSES.
Available data have demonstrated that, with regard to humans, U1-
AGTX-Ta1b-QA protein is not anticipated to be toxic or allergenic via
any reasonably foreseeable route of exposure. U1-AGTX-Ta1b-QA protein
is a modified form of agatoxin protein derived from the venom of the
hobo spider (Eratigena agrestis) that is intended for control of
insects and mites. In insects, the reported mode-of-action of U1-AGTX-
Ta1b-QA is allosteric inhibition of a non-desensitizing nicotinic
acetylcholine receptor, a neural receptor responsible for signal
transduction and function. The U1-AGTX-Ta1b-QA protein binds to a non-
signaling portion of the target (allosteric) site, altering the three-
dimensional structure of the neural receptor. According to the Center
of Disease Control (<a href="https://www.cdc.gov/niosh/topics/spiders/types.html">https://www.cdc.gov/niosh/topics/spiders/types.html</a>), the venom, from which the active ingredient is derived, is
not recognized as toxic to humans. Products formulated with U1AGTX-
Ta1b-QA will be used for foliar applications to plants or as a dip/
immersion for roots or cuttings.
Toxicological data provided by the petitioner indicate that U1-
AGTX-Ta1b-QA has low acute toxicity via the oral, dermal, inhalation,
route and it is not a dermal or eye irritant. This conclusion is
further supported by the results of the 90-day oral toxicity study,
prenatal development toxicity studies, and the absence of genotoxicity
in a bacterial
[[Page 9775]]
reverse mutation test. In addition, the protein sequence of U1-AGTX-
Ta1b-QA does not show significant homology to known allergens and thus
there is no indication of allergenic cross-reactivity.
Dietary exposure could occur if U1-AGTX-Ta1b-QA is used on crops
used for food. However, any risks associated with dietary exposures are
expected to be negligible due to the following hazard and exposure
considerations: U1-AGTX-Ta1b-QA (1) has a low overall toxicity profile
including low toxicity via the oral route of exposure; (2) does not
exhibit protein homology to putative or known allergens; (3) does not
show any prenatal developmental toxicity or genetic toxicity; and (4)
as described, was derived from the venom of the hobo spider, which is
not recognized as toxic to humans. In addition, food crops undergo a
post-harvest washing process to remove soil and surface residues, which
will therefore reduce the amounts of U1-AGTX-Ta1b-QA on the treated
crops. Root dip and cutting immersions, specifically, are expected to
result in negligible exposure of above-ground grown plant parts used
for food since these applications occur prior to planting and residues
are not expected to persist on the growing plant. Exposure through
drinking water is expected to be negligible as U1-AGTX-Ta1b-QA, as a
protein, is expected to be susceptible to biodegradation in the
environment as well as water treatment processes.
Non-occupational exposure could occur if bystanders are present in
areas treated with products containing U1-AGTX-Ta1b-QA protein.
However, submitted data have shown that U1-AGTX-Ta1b-QA is expected to
have low toxicity via the oral, dermal, and inhalation routes of
exposure, is minimally irritating to the eyes and skin, and is not a
dermal sensitizer; therefore, any risks from non-occupational exposure
are expected to be negligible.
Based upon the evaluation in the Human Health Risk Assessment,
which found no risk of concern from aggregate exposure to U1-AGTX-Ta1b-
QA, EPA concludes that there is reasonable certainty that no harm will
result to the U.S. population, including infants and children, from
aggregate exposure to residues of U1-AGTX-Ta1b-QA. This includes all
anticipated dietary exposures and all other exposures for which there
is reliable information. In addition, because no threshold effects have
been identified for infants and children, EPA determined that an
additional Food Quality Protection Act (FQPA) safety factor is not
necessary to protect infants and children from anticipated residues of
U1-AGTX-Ta1b-QA.
B. Analytical Enforcement Methodology
An analytical method is not required for U1-AGTX-Ta1b-QA since the
Agency is establishing an exemption from the requirement of a tolerance
without any numerical limitation based on a lack of adverse effects.
C. Response To Comment
One comment was received during the public comment period for the
notice of filing. The commentor provided general objections to EPA
establishing exemptions from tolerance for pesticides but did not
provide any specific or substantive objections to the petition to
exempt U1-AGTX-Ta1b-QA protein. Based on its review of the data and
other information submitted in support of the tolerance exemption
petition (as described above in Unit III.A), EPA has determined that a
tolerance exemption for U1-AGTX-Ta1b-QA protein is safe under the
FFDCA. Therefore, EPA is establishing a tolerance exemption for
residues of U1-AGTX-Ta1b-QA protein applied to food commodities.
D. Conclusion
Based on the conclusions detailed in Unit III.A., an exemption from
the requirement of a tolerance is established for residues of U1-AGTX-
Ta1b-QA protein in or on all food commodities when used in accordance
with label directions and good agricultural practices.
IV. Statutory and Executive Order Reviews
This action establishes an exemption under FFDCA section 408(d) in
response to a petition submitted to the Agency. 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 (PRA), 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 established on the basis
of a petition under FFDCA section 408(d), such as the exemption from
the requirement of a tolerance in this final rule, do not require the
issuance of a proposed rule, the requirements of the Regulatory
Flexibility Act (RFA) (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, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency 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, the Agency 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
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (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
[[Page 9776]]
and pests, Reporting and recordkeeping requirements.
Dated: January 29, 2024.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended 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. Add Sec. 180.1406 to subpart D to read as follows:
Sec. 180.1406 U1-AGTX-Ta1b-QA protein; exemption from the requirement
of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of U1-AGTX-Ta1b-QA protein in or on all food commodities when
used in accordance with label directions and good agricultural
practices.
[FR Doc. 2024-02787 Filed 2-9-24; 8:45 am]
BILLING CODE 6560-50-P
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