Bacillus Subtilis Strain CH4000; Exemption From the Requirement of a Tolerance, 65548-65550 [2024-17861]
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65548
Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Rules and Regulations
Dated: August 6, 2024.
Edward Messina,
Director, Office of Pesticide Programs.
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1410, to subpart D to
read as follows:
■
§ 180.1410 Bacillus paralicheniformis
strain CH0273; exemption from the
requirement of a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Bacillus paralicheniformis strain
CH0273 in or on all food commodities
when used in accordance with label
directions and good agricultural
practices.
[FR Doc. 2024–17860 Filed 8–9–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
[EPA–HQ–OPP–2022–0318; FRL–10390–01–
OCSPP]
Bacillus Subtilis Strain CH4000;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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
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SUMMARY:
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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: BPPDFR
Notices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Therefore, for the reasons stated in the
preamble, the EPA is amending 40 CFR
chapter I as follows:
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
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Fmt 4700
Sfmt 4700
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%20
electronic%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-sendcomments-epa-dockets.
E:\FR\FM\12AUR1.SGM
12AUR1
Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Rules and Regulations
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.
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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
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15:55 Aug 09, 2024
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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
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65549
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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65550
Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Rules and Regulations
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
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15:55 Aug 09, 2024
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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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1411 to subpart D to read
as follows:
■
§ 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
LEGAL SERVICES CORPORATION
45 CFR Part 1607
Governing Bodies
Legal Services Corporation.
Final rule.
AGENCY:
ACTION:
The Legal Services
Corporation’s (LSC) FY 2024
appropriation enacted on March 9,
2024, included language that lowered
the proportion of attorneys required to
serve on the governing bodies of LSC
grant recipients from 60% to 33%, and
eliminated the requirement that bar
associations appoint the majority of
attorneys. This final rule revises LSC’s
regulation pertaining to recipient
governing bodies to be consistent with
this directive from Congress.
DATES: This final rule is effective on
January 1, 2025.
SUMMARY:
PO 00000
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Fmt 4700
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FOR FURTHER INFORMATION CONTACT:
Stefanie K. Davis, Deputy General
Counsel, Legal Services Corporation,
3333 K Street NW, Washington, DC
20007; (202) 295–1563 (phone), (202)
337–6519 (fax), or sdavis@lsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The LSC Act of 1974 requires grant
recipients to have governing bodies
composed of at least 60% attorneys. 42
U.S.C. 2996f(c). LSC adopted Part 1607
and the 60% requirement in 1976. 41 FR
25899, June 23, 1976. Subsequently,
LSC’s fiscal year (FY) 1983
appropriation included a requirement
that a majority of each recipient’s
governing body be composed of
attorneys appointed by state or local bar
associations, also known as the
‘‘McCollum Amendment.’’ Public Law
97–276, 96 Stat. 1186. LSC revised Part
1607 in 1983 to implement the
McCollum Amendment. 48 FR 1971,
Jan. 17, 1983. The McCollum
Amendment currently appears in
§ 502(2)(b)(ii) of LSC’s FY 1996
appropriation, which is incorporated
through § 502 of LSC’s FY 1998
appropriation, as referenced in all LSC
appropriations from 1998 through 2024.
See, e.g., Public Law 104–134, 110 Stat.
1321; Public Law 105–119, 111 Stat.
2440; Public Law 118–42.
LSC’s FY 2024 appropriation changed
the minimum attorney percentage to
33% and eliminated the McCollum
Amendment requirement. The
Administrative Provision of this
appropriation reiterates the
incorporation of prior appropriations’
restrictions by reference. It also includes
language stating that for purposes of
applying the board composition
requirements described in LSC’s FY
1998 appropriation, the requirements
would be satisfied if at least 33% of a
grant recipient’s board were composed
of attorneys licensed in the state in
which legal assistance is to be provided.
Finally, it includes language stating that
the McCollum Amendment does not
apply. Public Law 118–42, Div. C, Title
IV, 141 (2024) .
LSC proposed to make the following
changes to incorporate the statutory
changes and to reorganize § 1607.3 for
ease of reference. First, LSC proposed to
delete § 1607.3(b)(1) in its entirety and
replace it with a new paragraph (b)(1)
stating that a recipient’s governing body
must be composed of at least 33%
attorneys. LSC proposed removing the
language implementing the McCollum
Amendment. LSC also proposed to
redesignate existing paragraphs (b)(2)
and (b)(3) as (b)(1)(i) and (b)(1)(ii),
respectively.
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Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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