[Federal Register Volume 89, Number 141 (Tuesday, July 23, 2024)]
[Rules and Regulations]
[Pages 59645-59648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16074]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0221; FRL-11818-01-OCSPP]


Trichoderma Atroviride Strain AT10; 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

[[Page 59646]]

tolerance for residues of Trichoderma atroviride strain AT10 in or on 
all food commodities when used in accordance with label directions and 
good agricultural practices. Agrotecnolog[iacute]as Naturales S.L., 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of Trichoderma atroviride strain AT10 
under FFDCA when used in accordance with this exemption.

DATES: This regulation is effective July 23, 2024. Objections and 
requests for hearings must be received on or before September 23, 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-2023-0221, 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. Please review the 
visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

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: 
[email protected].

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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     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 
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-2023-0221 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 23, 2024.
    The 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 Filing and 
Service,'' dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf. 
Although the EPA's regulations require submission via U.S. Mail or hand 
delivery, the EPA intends to treat submissions filed via electronic 
means as properly filed submissions; therefore, the 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 https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.
    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-2023-0221, by one of 
the following methods:
     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.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     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 July 5, 2023 (88 FR 42936) (FRL-10579-
05-OCSPP), 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 3F9053) by Agrotecnolog[iacute]as Naturales 
S.L., Ctra. T-214, s/n Km 4,125; 43762 Riera de Gai[agrave] La; 
Tarragona; Spain (c/o SciReg, Inc., 12733 Director's Loop, Woodbridge, 
VA 22192). 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 AT10 in or on all food commodities. 
That notice referenced a summary of the petition prepared by the 
petitioner, Agrotecnolog[iacute]as Naturales S.L. and available in the 
docket via https://www.regulations.gov. EPA received a comment on the 
notice of filing. EPA's response to this comment is discussed in Unit 
III.C. In addition, EPA modified the name of the active ingredient 
proposed in the notice of filing to conform with microbial active 
ingredient naming conventions from Trichoderma atroviride AT10 to 
Trichoderma atroviride strain AT10.

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.''

[[Page 59647]]

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 
Trichoderma atroviride strain AT10 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 
Trichoderma atroviride AT10, a New Active Ingredient, in the End Use 
Product (EP) TRICOTEN WP, Proposed for Registration and an Associated 
Petition Requesting a Tolerance Exemption'' (Trichoderma atroviride 
strain AT10 EP Human Health Risk Assessment). This document, as well as 
other relevant information, is available in the docket for this action 
as described under ADDRESSES.
    The toxicological profile of Trichoderma atroviride strain AT10 was 
previously described in the ``Human Health Risk Assessment of 
Trichoderma atroviride AT10, a New Active Ingredient, in the End Use 
Product (EP) TRICOTEN WP, Proposed for Registration and an Associated 
Petition Requesting a Tolerance Exemption''. Based upon its evaluation, 
EPA concludes that, with regard to humans, Trichoderma atroviride 
strain AT10 is not anticipated to be toxic, pathogenic, irritating, or 
infective. Significant dietary and non-occupational exposure to 
residues of Trichoderma atroviride strain AT10 are not expected as the 
products will be applied in agricultural settings, other non-
occupational exposures through drift or other measures are considered 
very unlikely. Even if dietary and non-occupational exposures to 
residues of Trichoderma atroviride strain AT10 were to occur, there is 
not concern due to the lack of adverse effects from toxicity and 
pathogenicity studies. Because there are no thresholds of concern with 
the toxicity, pathogenicity, or infectivity of Trichoderma atroviride 
strain AT10, 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 Trichoderma atroviride strain 
AT10, human health risk assessment, which concludes that there are no 
risks of concern from aggregate exposure to Trichoderma atroviride 
strain AT10, 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 AT10.

B. Analytical Enforcement Methodology

    An analytical method is not required for Trichoderma atroviride 
strain AT10 because EPA is establishing an exemption from the 
requirement of a tolerance without any numerical limitation.

C. Response to Comments

    One comment was received in response to the notice of filing. EPA 
reviewed the comment and determined that it was irrelevant to the 
tolerance exemption in this action.

D. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of Trichoderma atroviride strain AT10 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 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 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 (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

[[Page 59648]]

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: 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.  180.1409 to subpart D to read as follows:


Sec.  180.1409  Trichoderma atroviride strain AT10; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Trichoderma atroviride strain AT10 in or on all food 
commodities when used in accordance with label directions and good 
agricultural practices.

[FR Doc. 2024-16074 Filed 7-22-24; 8:45 am]
BILLING CODE 6560-50-P