[Federal Register Volume 90, Number 209 (Friday, October 31, 2025)]
[Rules and Regulations]
[Pages 48909-48911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19728]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 90, No. 209 / Friday, October 31, 2025 /
Rules and Regulations
[[Page 48909]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0621; FRL-12859-01-OCSPP]
Priestia Megaterium Strain SYM36613; 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 Priestia megaterium strain SYM36613,
formerly Bacillus aryabhattai strain SYM36613 (P. megaterium strain
SYM36613) in or on all food commodities when used in accordance with
label directions and good agricultural practices. Indigo Ag, 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 P. megaterium strain SYM36613 under
FFDCA when used in accordance with this exemption.
DATES: This regulation is effective October 31, 2025. Objections and
requests for hearings must be received on or before December 30, 2025
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-2023-0621, is available at
https://www.regulations.gov. Additional information about dockets
generally, along with instructions for visiting the docket center in
person, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Shannon Borges, 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. Executive Summary
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).
If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. What is EPA's authority for taking this action?
EPA is issuing this rulemaking under section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section
408(b)(2)(A)(i) allows EPA to establish a tolerance (the legal limit
for a pesticide chemical residue in or on a food) only if EPA
determines that the tolerance is ``safe.'' FFDCA section
408(b)(2)(A)(ii) 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. FFDCA section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
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 . . .''
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. If you fail to file an objection to the
final rule within the time period specified in the final rule, you will
have waived the right to raise any issues resolved in the final rule.
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-
2023-0621 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 December 30, 2025.
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 EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions; therefore, 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 at https://www.regulations.gov. Follow
the online instructions for submitting comments. Do not submit
electronically
[[Page 48910]]
any information you consider to be CBI or other information whose
disclosure is restricted by statute. If you wish to include CBI in your
request, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the
information that you claim to be CBI. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice.
II. Petitioned for Exemption
In the Federal Register of February 9, 2024 (89 FR 9104) (FRL-
10579-12-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 3F9071) by Indigo Ag, Inc., 500
Rutherford Ave., Charlestown, MA 02129. 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 P. megaterium
strain SYM36613 in or on all food commodities. That notice referenced a
summary of the petition prepared by the petitioner Indigo Ag, Inc. and
available in the docket via https://www.regulations.gov. EPA received
no comments in response to the notice of filing.
Based upon review of data and other information supporting the
petition, EPA modified the active ingredient name from Bacillus
aryabhattai strain SYM36613 to Priestia megaterium strain SYM36613.
III. Final Tolerance Actions
A. EPA's Safety Determination
EPA evaluated the available toxicological and exposure data on P.
megaterium strain SYM36613 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 Priestia (formerly
Bacillus) megaterium (formerly aryabhattai) strain SYM36613, a New
Active Ingredient, in [Priestia megaterium strain SYM36613 MUP
(Manufacturing-use Product)] and Indigo[supreg] 398 FP and
Indigo[supreg] 398 WD (End-use Products)] Proposed for Registration and
an Associated Petition Requesting a Tolerance Exemption,'' or the P.
megaterium strain SYM36613 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 toxicological profile of P. megaterium strain SYM36613 is
described in the P. megaterium strain SYM36613 Human Health Risk
Assessment. Based upon its evaluation, EPA concludes that with regards
to humans, P. megaterium strain SYM36613 is not anticipated to be
toxic, pathogenic, or infective. Significant dietary and non-
occupational exposure to residues of P. megaterium strain SYM36613 are
not expected as the products will only be applied in agricultural
settings early in the growing season, will only be applied directly to
soil and seed, and have not been approved for any residential uses.
Other non-occupational exposure through drift or other means are also
considered unlikely due to the low application rates proposed for end-
use products that are not expected to significantly increase the levels
of P. megaterium strain SYM36613 naturally present in the treated
environment. If this active ingredient were to enter surface or ground
water to some degree, it would likely be present at levels below that
of the naturally occurring P. megaterium organism and it would be even
further reduced in numbers by way of standard municipal drinking water
practices. Even if dietary and non-occupational exposures to residues
of P. megaterium strain SYM36613 were to occur, there are no risks of
concern due to the lack of adverse effects from toxicity,
pathogenicity, or infectivity of P. megaterium strain SYM36613 from the
results of the guideline mammalian toxicology testing. Further, because
food crops undergo postharvest washing, it is unlikely that significant
residues of P. megaterium strain would remain on treated crops.
EPA determined that no additional margin of safety is necessary to
protect infants and children as part of the qualitative assessment
conducted, as data and rationale demonstrated that there are no
threshold levels of concern with the toxicity, pathogenicity or
infectivity of P. megaterium strain SYM36613.
Based upon its evaluation in the P. megaterium strain SYM36613
Human Health Risk Assessment, which concludes that there are no risks
of concern from aggregate exposure to P. megaterium strain SYM36613,
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 P. megaterium strain SYM36613.
B. Analytical Enforcement Methodology
An analytical method is not required for P. megaterium strain
SYM36613 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 P. megaterium strain SYM36613 in or on all
food commodities when used in accordance with label directions and good
agricultural practices.
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review
This action is exempt from review under Executive Order 12866 (58
FR 51735, October 4, 1993), because it establishes or modifies a
pesticide tolerance or a tolerance exemption under FFDCA section 408 in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866.
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because actions that establish a tolerance exemption under FFDCA
section 408 are exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the PRA, 44 U.S.C. 3501 et seq., because it does not contain any
information collection activities.
D. Regulatory Flexibility Act (RFA)
This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA
applies only to rules subject to notice and comment rulemaking
requirements under the Administrative Procedure Act (APA), 5 U.S.C.
553, or any other statute. This rule is not subject to the APA but is
subject to FFDCA section 408(d), which does not require notice and
comment rulemaking to take this action in response to a petition.
[[Page 48911]]
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars and adjusted annually for inflation) as described
in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely
affect small governments. The action imposes no enforceable duty on any
State, local or Tribal governments or the private sector.
F. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not a significant regulatory action under
section 3(f)(1) of Executive Order 12866 (See Unit IV.A.), and because
EPA does not believe the environmental health or safety risks addressed
by this action present a disproportionate risk to children.
However, EPA's 2021 Policy on Children's Health applies to this
action. This rule finalizes an exemption from the requirement of a
tolerance under the FFDCA, which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance exemption and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .'' (FFDCA 408(b)(2)(C)). The Agency's consideration is
documented in Unit III.A.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not subject to Executive Order 13211 (66 FR 28355)
(May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.
J. National Technology Transfer Advancement Act (NTTAA)
This action does not involve technical standards that would require
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action 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: October 21, 2025.
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. 180.1420 to subpart D to read as follows:
Sec. 180.1420 Priestia megaterium strain SYM36613; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Priestia megaterium strain SYM36613 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.
[FR Doc. 2025-19728 Filed 10-30-25; 8:45 am]
BILLING CODE 6560-50-P