Rule2024-15375
Trichoderma atroviride Strain K5 NRRL B-50520; 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
July 16, 2024
Effective
July 16, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of Trichoderma atroviride strain K5 NRRL B- 50520 in or on all food commodities when used in accordance with label directions and good agricultural practices. Agrauxine Corp., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the exemption from a requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Trichoderma atroviride strain K5 NRRL B-50520 under FFDCA when used in accordance with the terms of the exemption.
Full Text
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<title>Federal Register, Volume 89 Issue 136 (Tuesday, July 16, 2024)</title>
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[Federal Register Volume 89, Number 136 (Tuesday, July 16, 2024)]
[Rules and Regulations]
[Pages 57770-57773]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15375]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0700; FRL-10420-01-OCSPP]
Trichoderma atroviride Strain K5 NRRL B-50520; 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 Trichoderma atroviride strain K5 NRRL B-
50520 in or on all food commodities when used in accordance with label
directions and good agricultural practices. Agrauxine Corp., submitted
a petition to EPA under the Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting the exemption from a requirement of a tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of Trichoderma atroviride strain K5 NRRL B-50520
under FFDCA when used in
[[Page 57771]]
accordance with the terms of the exemption.
DATES: This regulation is effective July 16, 2024. Objections and
requests for hearings must be received on or before September 16, 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-2020-0700, 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 20460-0001. 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 H. 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#8ccedcdcc8cadec2e3f8e5efe9ffcce9fceda2ebe3fa"><span class="__cf_email__" data-cfemail="165446465250445879627f7573655673667738717960">[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://ecfr.gov/current/title-40">https://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-2020-0700 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
September 16, 2024. EPA's Office of Administrative Law Judges (OALJ),
in which the Hearing Clerk is housed, urges parties to file and serve
documents by electronic means only, notwithstanding any other
particular requirements set forth in other procedural rules governing
those proceedings. See ``Revised Order Urging Electronic Service and
Filing'', dated June 22, 2023, which can be found at <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</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; therefore, EPA believes the preference
for submission via electronic means will not be prejudicial. When
submitting documents to the OALJ electronically, 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>.
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-2020-0700, 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 December 21, 2021 (86 FR 72200) (FRL-
8792-06), 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 0F8867) by Agrauxine Corp., 375 Bonnewitz Avenue, Van
Wert, OH 45981. The petition requested that 40 CFR part 180 be amended
by establishing an exemption from the requirement of a tolerance for
residues of Trichoderma atroviride strain K5 NRRL B-50520 in or on all
food commodities (although not expressly stated in the petition, EPA
interpreted the petition as requesting an exemption covering all food
commodities). That document referenced a summary of the petition
prepared by the petitioner Agrauxine Corp., which is available in the
docket via <a href="https://www.regulations.gov">https://www.regulations.gov</a>. No comments were received on
the notice of filing.
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
[[Page 57772]]
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
Trichoderma atroviride strain K5 NRRL B-50520 and considered its
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 that data can be
found within the document entitled ``Human Health Risk Assessment of
Trichoderma atroviride strain K5, a New Active Ingredient, in 86431-GL
(Manufacturing-use Product) and 86431-GA (End-use Product) Proposed for
Registration and an Associated Petition Requesting a Tolerance
Exemption'' (Trichoderma atroviride strain K5 NRRL B-50520 Human Health
Risk Assessment). This document, as well as other relevant information,
is available in the docket for this action as described under
ADDRESSES.
Based upon its evaluation, EPA concludes that Trichoderma
atroviride strain K5 NRRL B-50520 is not toxic, pathogenic, or
infective via the oral, pulmonary, or injection routes of exposure; and
is not expected to be toxic via dermal or inhalation routes of exposure
based on the data presented in the three toxicity/pathogenicity
studies. Additionally, all three of the toxicity/pathogenicity studies
demonstrated a pattern of clearance of Trichoderma atroviride strain K5
NRRL B-50520 from the blood and organs of the test animals. Based on
lack of adverse effects seen in the available toxicity/pathogenicity
data, EPA does not expect any dietary exposure, drinking water
exposure, non-occupational and residential exposures resulting from the
use of this pesticide to pose any quantifiable risk; thus, no
qualitative risk assessment was conducted. Significant dietary and non-
occupational exposures to residues of Trichoderma atroviride strain K5
NRRL B-50520 are not anticipated because it will be applied via seed or
soil-directed treatment, and it is not expected to remain at high
levels on plant surfaces or readily percolate through soil before
reaching ground water. Although there may be some exposure to residues
when used on food commodities in accordance with label directions and
good agricultural practices, there is a reasonable certainty that such
exposure will not cause adverse effects. EPA also determined that
retention of the Food Quality Protection Act (FQPA) safety factor for
infants and children was not necessary as part of the qualitative
assessment conducted for Trichoderma atroviride strain K5 NRRL B-50520,
because there are no threshold levels of concern when used in
accordance with label directions and good agricultural practices.
Based upon its evaluation, 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
Trichoderma atroviride strain K5 NRRL B-50520. Therefore, an exemption
from the requirement of a tolerance is established for residues of
Trichoderma atroviride strain K5 NRRL B-50520 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.
B. Analytical Enforcement Methodology
EPA is establishing an exemption from the requirement of a
tolerance for residues of Trichoderma atroviride strain K5 NRRL B-50520
in or on all food commodities without any numerical limitation and thus
an analytical method is not required for enforcement purposes.
IV. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance 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
(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 tolerance
exemption in this action, 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. 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 (UMRA) (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 (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 and pests, Reporting and
recordkeeping requirements.
[[Page 57773]]
Dated: June 24, 2024.
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. Add Sec. 180.1397 to subpart D to read as follows:
Sec. 180.1397 Trichoderma atroviride strain K5 NRRL B-50520;
exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Trichoderma atroviride strain K5 NRRL B-50520 in or on all
food commodities when used in accordance with label directions and good
agricultural practices.
[FR Doc. 2024-15375 Filed 7-15-24; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on July 16, 2024.
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