[Federal Register Volume 89, Number 155 (Monday, August 12, 2024)]
[Rules and Regulations]
[Pages 65548-65550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17861]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0318; FRL-10390-01-OCSPP]


Bacillus Subtilis Strain CH4000; 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 Bacillus subtilis strain CH4000 in or on 
all food commodities when used in accordance with label directions and 
good agricultural practices. Chr. Hansen Inc., submitted a petition to 
the 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 Bacillus subtilis strain CH4000 under FFDCA when used 
in accordance with this exemption.

DATES: This regulation is effective August 12, 2024. Objections and 
requests for hearings must be received on or before October 11, 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-2022-0318, 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 the EPA, you must 
identify docket ID number EPA-HQ-OPP-2022-0318 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 October 11, 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 the EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2022-0318, 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.

[[Page 65549]]

    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 April 28, 2022 (87 FR 25178) (FRL-9410-
12), the 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 1F8944) by Chr. Hansen, Inc., 9015 W Maple 
Street, Milwaukee, WI 53214, USA. The petition requested that 40 CFR 
part 180 be amended by establishing an exemption from the requirement 
of a tolerance for residues of the fungicide and nematicide Bacillus 
subtilis strain CH4000 in or on all food commodities. That notice 
referenced a summary of the petition prepared by the petitioner Chr. 
Hansen, Inc., and available in the docket via https://www.regulations.gov. The EPA received a comment on the notice of 
filing. The EPA's response to this comment is discussed in Unit III.C.

III. Final Rule

A. The EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows the 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 the 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, the EPA must take into account the 
factors set forth in FFDCA section 408(b)(2)(C), which require the 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 the EPA consider ``available information 
concerning the cumulative effects of [a particular pesticide's] . . . 
residues and other substances that have a common mechanism of 
toxicity.''
    The EPA evaluated the available toxicological and exposure data on 
Bacillus subtilis strain CH4000 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 
the EPA relied and its risk assessment based on those data can be found 
within the document entitled ``Human Health Risk Assessment of Bacillus 
paralicheniformis strain CH0273 and Bacillus subtilis strain CH4000, 
two New Active Ingredients, in the Manufacturing-use Products (MUPs) 
CH0273 (2375-U) and CH4000 (2375-A), and End-use Products (EPs) Kansas 
3 SC (2375-L) and Kansas 3 WP (2375-T) Proposed for Registration and 
two Associated Petitions Requesting Tolerance Exemptions.'' 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, 
Bacillus subtilis strain CH4000, is not toxic, pathogenic, irritating, 
or infective. According to the toxicity/infectivity and acute studies, 
Bacillus subtilis strain CH4000 has a low toxicity profile, and no 
toxicological endpoints were identified. This active ingredient is a 
biological fungicide and nematicide and the proposed mode of action is 
mediated by the mechanisms of antagonism of pest and pathogens, 
promotion of host nutrition and growth, and stimulation of plant host 
defenses. Application of products containing Bacillus subtilis will 
briefly result in adding to the bacterial population already present in 
the environment. However, population levels for this active ingredient 
are expected to decrease to environmental background levels relatively 
rapidly following application. This active ingredient is present in the 
environment and humans are naturally exposed to it. Dietary and 
drinking water exposure is expected to be negligible since significant 
residues are not expected because the EPs containing this active 
ingredient are meant for indirect application to food crops through 
seed and soil treatment. The EPA does not expect dietary (food and 
drinking water) or other non-occupational risks from use of Bacillus 
subtilis strain CH4000 as a microbial active ingredient in the proposed 
pesticide products.
    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, 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.'' No risk of cumulative toxicity/effects 
from Bacillus subtilis strain CH4000 has been identified as no toxicity 
has been shown for Bacillus subtilis strain CH4000 in the submitted 
studies. Therefore, the EPA has not assumed that Bacillus subtilis 
strain CH4000 has a common mechanism of toxicity with other substances.
    Additionally, although FFDCA section 408(b)(2)(C) provides for an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects, the EPA has determined that there are no 
such effects due to the lack of toxicity of Bacillus subtilis strain 
CH4000. Because there are no threshold levels of concern with the 
toxicity, pathogenicity, or infectivity of Bacillus subtilis strain 
CH4000, the 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 of 
Bacillus paralicheniformis strain CH0273 and Bacillus subtilis strain 
CH4000, which concludes that there are no risks of concern from 
aggregate exposure to Bacillus subtilis strain CH4000, the 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 Bacillus subtilis strain CH4000.

B. Analytical Enforcement Methodology

    An analytical method is not required for Bacillus subtilis strain 
CH4000 because the 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. The 
EPA reviewed the comment and determined that it was irrelevant to the 
tolerance exemption in this action.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section 
408(d) in response to a petition submitted to the 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

[[Page 65550]]

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, the 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, the 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 the 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.), 
the 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: August 6, 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.  180.1411 to subpart D to read as follows:


Sec.  180.1411  Bacillus subtilis strain CH4000; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Bacillus subtilis strain CH4000 in or on all food 
commodities when used in accordance with label directions and good 
agricultural practices.

[FR Doc. 2024-17861 Filed 8-9-24; 8:45 am]
BILLING CODE 6560-50-P