Rule2024-17861
Bacillus Subtilis Strain CH4000; 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
August 12, 2024
Effective
August 12, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 155 (Monday, August 12, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<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 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 <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#89cbd9d9cdcfdbc7e6fde0eaecfac9ecf9e8a7eee6ff"><span class="__cf_email__" data-cfemail="ce8c9e9e8a889c80a1baa7adabbd8eabbeafe0a9a1b8">[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://www.ecfr.gov/current/title-40">https://www.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 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 <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 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 <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 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:
<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>.
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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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
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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
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</html>Indexed from Federal Register on August 12, 2024.
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