Rule2026-18830
Bacillus amyloliquefaciens strain AT-332; Exemption From the Requirement of a Pesticide 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
September 15, 2026
Effective
September 15, 2026
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of Bacillus amyloliquefaciens strain AT-332 in or on all food and feed commodities when used in accordance with label directions and good agricultural practices. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Gowan Company, in cooperation with SDS Biotech K.K., c/o Landis International, Inc., submitted a petition to EPA requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of this pesticide when used in accordance with the terms of the exemption.
Full Text
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<title>Federal Register, Volume 91 Issue 177 (Tuesday, September 15, 2026)</title>
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[Federal Register Volume 91, Number 177 (Tuesday, September 15, 2026)]
[Rules and Regulations]
[Pages 58378-58381]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18830]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0308; 13314-01-OCSPP]
Bacillus amyloliquefaciens strain AT-332; Exemption From the
Requirement of a Pesticide 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 amyloliquefaciens strain AT-332
in or on all food and feed commodities when used in accordance with
label directions and good agricultural practices. Under
[[Page 58379]]
the Federal Food, Drug, and Cosmetic Act (FFDCA), Gowan Company, in
cooperation with SDS Biotech K.K., c/o Landis International, Inc.,
submitted a petition to EPA requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of this pesticide
when used in accordance with the terms of the exemption.
DATES: This rule is effective on September 15, 2026. Objections and
requests for hearings must be received on or before November 16, 2026,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of this document).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2024-0308, is available online at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket center in
person, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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; telephone number: (202) 566-1400; email address:
<a href="/cdn-cgi/l/email-protection#a4e6f4f4e0e2f6eacbd0cdc7c1d7e4c1d4c58ac3cbd2"><span class="__cf_email__" data-cfemail="387a68687c7e6a76574c515b5d4b785d4859165f574e">[email protected]</span></a>.
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 might apply to
them:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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(c)(2)(A)(i) allows EPA to establish an exemption from the
requirement for a tolerance (the legal limit for a pesticide chemical
residue in or on a food) only if EPA determines that the exemption is
``safe.'' FFDCA section 408(c)(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. 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 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 Agency
consider, among other things, ``available information concerning the
cumulative effects of a particular pesticide's residues'' and ``other
substances that have a common mechanism of toxicity.''
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 the docket ID number EPA-HQ-
OPP-2024-0308 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 November 16, 2026.
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 ``Order Urging Electronic Filing and Service,'' dated
December 3, 2025, which can be found at <a href="https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf">https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf</a>. 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 <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 at <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. If you wish to
include CBI in your request, please follow the applicable instructions
at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> 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 May 20, 2022 (87 FR 30855) (FRL-9410-13-
OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 1F8915) by
Gowan Company in cooperation with SDS Biotech K.K., c/o Landis
International, Inc. (P.O. Box 5126, 3185 Madison Highway, Valdosta, GA
31603). 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 Bacillus amyloliquefaciens strain AT-332 in
or on all food commodities. That document referenced a summary of the
petition prepared by the petitioner and included in the docket.
There were no comments received in response to the notice of
filing. EPA modified the tolerance exemption by removing ``fungicide.''
The reason for this change is explained in Unit III.C.
[[Page 58380]]
III. Final Tolerance Actions
A. EPA's Safety Determination
EPA has assessed the individual risks from exposure to the
pesticide active ingredients identified and discussed in this rule,
taking into consideration all reliable data on toxicity and exposure,
including for infants and children, and has included a safety finding
under FFDCA section 408(b) for the tolerance actions in this rule. 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 Bacillus amyloliquefaciens strain AT-332, a New Active
Ingredient, in SB-950 (Manufacturing-use Product) and SB-9503 (End-use
Product) Proposed for Registration and an Associated Petition
Requesting a Tolerance Exemption.'' (Bacillus amyloliquefaciens strain
AT-332 Human Health Risk Assessment). This document, as well as other
relevant information, is available in the docket for this action,
docket ID number EPA-HQ-OPP-2024-0308.
The toxicological profile of Bacillus amyloliquefaciens strain AT-
332 is described in the Bacillus amyloliquefaciens strain AT-332 Human
Health Risk Assessment. Based upon its evaluation, EPA concludes that,
with regards to humans, Bacillus amyloliquefaciens strain AT-332 is not
anticipated to be toxic, pathogenic, or infective. Bacillus
amyloliquefaciens strain AT-332 is ubiquitous in soil and the
rhizosphere. Dietary and drinking water and residential exposure is
expected. However, Bacillus amyloliquefaciens is present in soil, on
fresh produce, and in water. Further, food crops undergo postharvest
washing and municipal water treatment practices would reduce any
residues further. Even if dietary or residential exposure to residues
of Bacillus amyloliquefaciens strain AT-332 were to occur, there are no
risks of concern due to the lack of adverse effects from toxicity,
pathogenicity, or infectivity of Bacillus amyloliquefaciens strain AT-
332. 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 Bacillus
amyloliquefaciens strain AT-332 is not toxic, pathogenic, or infective.
Based on the supporting assessments and registration review
documents, which demonstrate that the aggregate exposure for each
individual chemical is below the Agency's level of concern, EPA
concludes there is a reasonable certainty that no harm will result to
the general population, or specifically to infants and children, from
aggregate exposure to residues of the pesticide active ingredients
identified and discussed in this action.
B. Analytical Enforcement Methodology
An analytical method is not required for Bacillus amyloliquefaciens
strain AT-332 because EPA is establishing an exemption from the
requirement of a tolerance without any numerical limitation.
C. Revisions to the Requested Tolerance Exemption
The Agency removed the descriptor ``fungicide'' from the tolerance
exemption to reduce any unnecessary future regulatory burden and
conform with current standard practices.
D. Conclusion
Therefore, EPA is finalizing the tolerance exemption that was
petitioned for by Gowan Company in cooperation with SDS Biotech K.K.,
c/o Landis International, Inc. (PP 1F8915) for residues of Bacillus
amyloliquefaciens strain AT-332 in or on all food commodities when used
in accordance with label directions and good agricultural practices.
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/laws-regulations/and-executive-orders">https://www.epa.gov/laws-regulations/and-executive-orders</a>.
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 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.
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, 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 2026 Policy on Children's Health applies to this
action. This rule finalizes tolerance actions under the FFDCA, which
requires EPA to give special consideration to
[[Page 58381]]
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 . . .'' (FFDCA
408(b)(2)(C)). The Agency's consideration is documented in the
pesticide-specific review documents, located in the applicable docket
at <a href="https://www.regulations.gov">https://www.regulations.gov</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 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: September 9, 2026.
Edward Messina,
Director, Office of Pesticide Programs.
For the reasons set forth 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. 180.1425 to Subpart D to read as follows:
Sec. 180.1425 Bacillus amyloliquefaciens strain AT-332; exemption
from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Bacillus amyloliquefaciens strain AT-332 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.
[FR Doc. 2026-18830 Filed 9-14-26; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.