[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Rules and Regulations]
[Pages 60366-60368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20653]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0324; FRL-10013-33]


Trichoderma asperellum, Strain T34; 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 asperellum, strain T34 in or 
on all food commodities when used in accordance with label directions 
and good agricultural practices. Biocontrol Technologies 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 asperellum, strain T34 under FFDCA 
when used in accordance with this exemption.

DATES: This regulation is effective September 25, 2020. Objections and 
requests for hearings must be received on or before November 24, 2020, 
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-2019-0324, is available at http://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 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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anne Overstreet, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (703) 305-7090; 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 Government Publishing Office's e-CFR site at 
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2019-0324 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 
November 24, 2020. 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-2019-0324, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of August 2, 2019 (84 FR 37818) (FRL-9996-
78), 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 9F8735) by Biocontrol Technologies, S.L. Avgda. Madrid, 
215-217, entres[ograve]l A 08014 Barcelona, Spain (c/o Wagner 
Regulatory Associates, Inc., P.O. Box 640, Hockessin, DE 19707). The 
petition requested that 40 CFR part 180 be amended by establishing an 
exemption from the requirement of a tolerance for residues of 
Trichoderma asperellum, strain T34 in or on all food commodities. That 
document referenced a summary of the petition prepared by the 
petitioner Biocontrol Technologies, S.L., which is available in the 
docket via http://www.regulations.gov. There were no comments received 
in response to 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

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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 making a safety 
determination to establish 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 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 toxicity and exposure data on 
Trichoderma asperellum, strain T34 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 ``Federal Food, Drug, and Cosmetic Act 
(FFDCA) Safety Determination for Trichoderma asperellum, strain T34.'' 
This document, as well as other relevant information, is available in 
the docket for this action as described under ADDRESSES.
    The available data demonstrated that, with regard to humans, 
Trichoderma asperellum, strain T34 is not toxic, pathogenic, or 
infective via any reasonably foreseeable route of exposure. The 
submitted acute oral toxicity/pathogenicity and acute pulmonary 
toxicity/pathogenicity studies demonstrated no signs of toxicity, 
infectivity, or pathogenicity. Although the first submitted acute 
injection toxicity/pathogenicity study caused mortality to the test 
animals, the mortality was attributed to high spore concentration, not 
due to toxin production, as demonstrated by data and information 
required by EPA to address the mortality. A second injection toxicity/
pathogenicity study was performed at a lower dose and only two of the 
24 test animals died. Additional acute injection toxicity/pathogenicity 
studies were required as a term of registration to address a concern 
relating to culture filtrates and killed cultures. The studies 
demonstrated no toxicity to the test animals when injected with either 
Trichoderma asperellum, strain T34 spores or culture filtrate. 
Furthermore, acute oral, dermal, and inhalation toxicity studies and 
acute eye and primary dermal irritation studies conducted with a 
mixture containing Trichoderma asperellum, strain T34 demonstrated no 
toxic or irritant effects. Although there may be dietary and non-
occupational exposure to residues of Trichoderma asperellum, strain T34 
when it is used on food commodities, there is not a concern due to the 
lack of potential for adverse effects. EPA also determined that 
retention of the Food Quality Protection Act safety factor was not 
necessary as part of the qualitative assessment conducted for 
Trichoderma asperellum, strain T34.
    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 asperellum, strain T34. Therefore, an exemption from the 
requirement of a tolerance is established for residues of Trichoderma 
asperellum, strain T34 in or on all food commodities when used in 
accordance with label directions and good agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method for enforcement purposes is not required 
because EPA has determined that reasonably foreseeable exposure to 
residues of Trichoderma asperellum, strain T34 from use of the 
pesticide will be safe, due to lack of toxicity, pathogenicity, and 
infectivity. Under those circumstances, it is unnecessary to have an 
analytical method to monitor for residues.

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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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.

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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: September 2, 2020.
Edward Messina,
Acting 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.  180.1379 to subpart D to read as follows:


Sec.  180.1379  Trichoderma asperellum, strain T34; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Trichoderma asperellum, strain T34 in or on all food 
commodities when used in accordance with label directions and good 
agricultural practices.

[FR Doc. 2020-20653 Filed 9-24-20; 8:45 am]
BILLING CODE 6560-50-P