Bacillus Licheniformis Strain 414-01; Exemption From the Requirement of a Tolerance, 68112-68114 [2024-18935]
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68112
Federal Register / Vol. 89, No. 164 / Friday, August 23, 2024 / Rules and Regulations
Dated: August 8, 2024.
Charles Smith,
Director, Registration Division, Office of
Pesticide Programs.
order, the polymer ‘‘Oxirane, phenyl-,
polymer with oxirane,
mono(dihydrogen phosphate), decyl
ether, minimum number average
molecular weight (in amu) 1300’’ to read
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:
■
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, amend table 1 to
§ 180.960 by adding, in alphabetical
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
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TABLE 1 TO § 180.960
Polymer
CAS No.
*
*
*
*
*
*
Oxirane, phenyl-, polymer with oxirane, mono(dihydrogen phosphate), decyl ether, minimum number average
molecular weight (in amu) 1300 ............................................................................................................................
*
*
*
[FR Doc. 2024–18909 Filed 8–22–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2023–0146; FRL–11652–01–
OCSPP]
Bacillus Licheniformis Strain 414–01;
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
licheniformis strain 414–01 in or on
food commodities. when used in
accordance with label directions and
good agricultural practices. UPL NA,
Inc., 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 Bacillus licheniformis
strain 414–01 under FFDCA when used
in accordance with this exemption.
DATES: This regulation is effective
August 23, 2024. Objections and
requests for hearings must be received
on or before October 22, 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–2023–0146, is
available at https://www.regulations.gov
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SUMMARY:
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16:00 Aug 22, 2024
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*
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:
BPPDFRNotices@epa.gov.
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).
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308336–53–0
*
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/chapter-I/
subchapter-E/part-180.
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–2023–0146, 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 22, 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
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Federal Register / Vol. 89, No. 164 / Friday, August 23, 2024 / Rules and Regulations
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/eabalj_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–
2023–0146, 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.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
khammond on DSKJM1Z7X2PROD with RULES
II. Background
In the Federal Register of March 24,
2023 (88 FR 17779) (FRL–10579–02–
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 2F9017) by UPL NA, Inc., 630
Freedom Business Center, Suite 402,
King of Prussia, PA 19406. The petition
requested that 40 CFR part 180 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of Bacillus licheniformis strain
414–01 in or on all food commodities.
That notice referenced a summary of the
petition prepared by the petitioner UPL
NA, Inc. and available in the docket via
https://www.regulations.gov. EPA
received no comments in response to
the notice of filing.
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16:00 Aug 22, 2024
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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.’’
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
Bacillus licheniformis strain 414–01 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 the
New Active Ingredient Bacillus
licheniformis strain 414–01 in the
Proposed Manufacturing-use Product
(MUP) Bacillus licheniformis strain
414–01 MUP and End-use Products
(EPs) 414–02 and 414–03 for FIFRA
Section 3 Registration and an
Associated Petition Requesting a
Tolerance Exemption’’ (Bacillus
licheniformis strain 414–01 MUP and
EPs 414–02 and 414–03 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 available data and information
demonstrated that, with regard to
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68113
humans, Bacillus licheniformis strain
414–01 is not anticipated to be toxic,
pathogenic, or infective via any route of
exposure. Significant dietary and nonoccupational exposures to residues of
Bacillus licheniformis strain 414–01 are
not expected as the products will be
applied in agricultural settings by seed
treatment and direct soil applications,
other non-occupational exposures
through drift or other measures are
considered very unlikely. Even if
dietary and non-occupational exposures
to residues of Bacillus licheniformis
strain 414–01 were to occur, there is not
concern due to the lack of adverse
effects from toxicity and pathogenicity
studies. Because there are no threshold
levels of concern with the toxicity,
pathogenicity, or infectivity of Bacillus
licheniformis strain 414–01, EPA
determined that the additional margin
of safety referred to as the Food Quality
Protection Act (FQPA) Safety Factor
(SF) is not necessary to protect infants
and children as part of the qualitative
assessment conducted.
Based upon its evaluation in the
Bacillus licheniformis strain 414–01
MUP and EPs 414–02 and 414–03
Human Health Risk Assessment, which
concludes that there are no risks of
concern from aggregate exposure to
Bacillus licheniformis strain 414–01,
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 licheniformis strain
414–01.
B. Analytical Enforcement Methodology
An analytical method is not required
for Bacillus licheniformis strain 414–01
because EPA is establishing an
exemption from the requirement of a
tolerance without any numerical
limitation.
C. Conclusion
Therefore, an exemption from the
requirement of a tolerance is established
for residues of Bacillus licheniformis
strain 414–01 in or on in or on all food
commodities.
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
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Federal Register / Vol. 89, No. 164 / Friday, August 23, 2024 / Rules and Regulations
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
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16:00 Aug 22, 2024
Jkt 262001
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 12, 2024.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR part
180 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 § 180.1412 to subpart D to read
as follows:
■
§ 180.1412 Bacillus licheniformis strain 414–
01; exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Bacillus licheniformis strain 414–01
in or on all food commodities when
used in accordance with label directions
and good agricultural practices.
[FR Doc. 2024–18935 Filed 8–22–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2023–0259; FRL–12119–01–
OCSPP]
Ethaboxam; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of ethaboxam in
or on leaf petiole vegetable subgroup
22B. The Interregional Project Number 4
(IR–4) requested this tolerance under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective
August 23, 2024. Objections and
requests for hearings must be received
on or before October 22, 2024, and must
SUMMARY:
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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–2023–0259, is
available at https://www.regulations.gov
or in-person 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 and the OPP Docket is
(202) 566–1744. For the latest status
information on EPA/DC services, docket
access, visit https://www.epa.gov/
dockets.
FOR FURTHER INFORMATION CONTACT:
Charles Smith, Director, Registration
Division (7505T), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (202) 566–1030;
email address: RDFRNotices@epa.gov.
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 EPA’s tolerance
regulations at 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
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]]>Agencies
[Federal Register Volume 89, Number 164 (Friday, August 23, 2024)]
[Rules and Regulations]
[Pages 68112-68114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18935]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0146; FRL-11652-01-OCSPP]
Bacillus Licheniformis Strain 414-01; 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 licheniformis strain 414-01 in
or on food commodities. when used in accordance with label directions
and good agricultural practices. UPL NA, Inc., 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 Bacillus licheniformis strain 414-01 under FFDCA when used
in accordance with this exemption.
DATES: This regulation is effective August 23, 2024. Objections and
requests for hearings must be received on or before October 22, 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-2023-0146, 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/chapter-I/subchapter-E/part-180.
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-2023-0146, 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 22, 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
[[Page 68113]]
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-2023-0146, 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 March 24, 2023 (88 FR 17779) (FRL-10579-
02-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 2F9017) by UPL NA, Inc., 630 Freedom Business
Center, Suite 402, King of Prussia, PA 19406. The petition requested
that 40 CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for residues of Bacillus licheniformis
strain 414-01 in or on all food commodities. That notice referenced a
summary of the petition prepared by the petitioner UPL NA, Inc. and
available in the docket via https://www.regulations.gov. EPA received
no comments 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 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.'' 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
Bacillus licheniformis strain 414-01 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 the New
Active Ingredient Bacillus licheniformis strain 414-01 in the Proposed
Manufacturing-use Product (MUP) Bacillus licheniformis strain 414-01
MUP and End-use Products (EPs) 414-02 and 414-03 for FIFRA Section 3
Registration and an Associated Petition Requesting a Tolerance
Exemption'' (Bacillus licheniformis strain 414-01 MUP and EPs 414-02
and 414-03 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 available data and information demonstrated that, with regard
to humans, Bacillus licheniformis strain 414-01 is not anticipated to
be toxic, pathogenic, or infective via any route of exposure.
Significant dietary and non-occupational exposures to residues of
Bacillus licheniformis strain 414-01 are not expected as the products
will be applied in agricultural settings by seed treatment and direct
soil applications, other non-occupational exposures through drift or
other measures are considered very unlikely. Even if dietary and non-
occupational exposures to residues of Bacillus licheniformis strain
414-01 were to occur, there is not concern due to the lack of adverse
effects from toxicity and pathogenicity studies. Because there are no
threshold levels of concern with the toxicity, pathogenicity, or
infectivity of Bacillus licheniformis strain 414-01, EPA determined
that the additional margin of safety referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF) is not necessary to protect
infants and children as part of the qualitative assessment conducted.
Based upon its evaluation in the Bacillus licheniformis strain 414-
01 MUP and EPs 414-02 and 414-03 Human Health Risk Assessment, which
concludes that there are no risks of concern from aggregate exposure to
Bacillus licheniformis strain 414-01, 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 licheniformis strain 414-01.
B. Analytical Enforcement Methodology
An analytical method is not required for Bacillus licheniformis
strain 414-01 because EPA is establishing an exemption from the
requirement of a tolerance without any numerical limitation.
C. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of Bacillus licheniformis strain 414-01 in or
on in or on all food commodities.
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
[[Page 68114]]
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 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 12, 2024.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR part 180 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. 180.1412 to subpart D to read as follows:
Sec. 180.1412 Bacillus licheniformis strain 414-01; exemption from
the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Bacillus licheniformis strain 414-01 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.
[FR Doc. 2024-18935 Filed 8-22-24; 8:45 am]
BILLING CODE 6560-50-P
