Rule2025-05173
Pseudomonas Oryzihabitans Strain SYM23945; Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 27, 2025
Effective
March 27, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of Pseudomonas oryzihabitans strain SYM23945 in or on all food commodities when used in accordance with label directions and good agricultural practices. Indigo Ag, 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 Pseudomonas oryzihabitans strain SYM23945 under FFDCA when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 90 Issue 58 (Thursday, March 27, 2025)</title>
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[Federal Register Volume 90, Number 58 (Thursday, March 27, 2025)]
[Rules and Regulations]
[Pages 13838-13840]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-05173]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0503; FRL-12664-01-OCSPP]
Pseudomonas Oryzihabitans Strain SYM23945; 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 Pseudomonas oryzihabitans strain
SYM23945 in or on all food commodities when used in accordance with
label directions and good agricultural practices. Indigo Ag, 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 Pseudomonas oryzihabitans strain
SYM23945 under FFDCA when used in accordance with this exemption.
DATES: This regulation is effective March 27, 2025. Objections and
requests for hearings must be received on or before May 27, 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-2023-0503, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Madison H. Le, Biopesticides and
Pollution Prevention Division (7511M), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1400; email address:
<a href="/cdn-cgi/l/email-protection#b7f5e7e7f3f1e5f9d8c3ded4d2c4f7d2c7d699d0d8c1"><span class="__cf_email__" data-cfemail="a8eaf8f8eceefae6c7dcc1cbcddbe8cdd8c986cfc7de">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
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 the EPA, you must identify docket ID number EPA-HQ-
OPP-2023-0503 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 May 27, 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 <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</a>.
Although 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
[[Page 13839]]
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 February 9, 2024 (89 FR 9103) (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 2F9043) 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 nematicide Pseudomonas
oryzihabitans strain SYM23945 in or on all food commodities. That
notice referenced a summary of the petition prepared by the petitioner
Indigo Ag, Inc. and is available in the docket. EPA received two
comments in response to the notice of filing. EPA's response to these
comments is discussed in Unit III.C.
EPA has omitted the term ``nematicide'' from the exemption
established in this action. The reason for this change is explained in
Unit III.D.
III. Final Tolerance Actions
A. EPA's Safety Determination
EPA evaluated the available toxicological and exposure data on
Pseudomonas oryzihabitans strain SYM23945 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
Pseudomonas oryzihabitans strain SYM23945, a New Active Ingredient in
Pseudomonas oryzihabitans strain SYM23945 Technical, Pseudomonas
oryzihabitans strain SYM23945 MUP, and Indigo 407 FP Proposed for
Registration and an Associated Petition Requesting a Tolerance
Exemption'' (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 Pseudomonas oryzihabitans strain
SYM23945 is described in the Pseudomonas oryzihabitans strain SYM23945
Human Health Risk Assessment. Based upon its evaluation, EPA concludes
that with regards to humans, Pseudomonas oryzihabitans strain SYM23945
is not toxic, pathogenic, or infective via the oral, pulmonary, or
injection routes of exposure. Additionally, a pattern of clearance was
demonstrated from the test animals indicating a lack of pathogenicity
or infectivity of Pseudomonas oryzihabitans strain SYM2394. Significant
dietary and non-occupational exposures to residues of Pseudomonas
oryzihabitans strain SYM23945 are not expected as the pesticide will be
applied as a seed treatment only, reducing the likelihood of pesticide
residues on food crops or of off-site, airborne or runoff movement of
this active ingredient. However, if this active ingredient were to
enter the environment, it would likely be present at levels below those
of naturally occurring Pseudomonas oryzihabitans due to relatively low
application rates and use patterns. Further, because food crops undergo
postharvest washing, it is unlikely that significant residues of
Pseudomonas oryzihabitans strain SYM23945 would remain on treated
crops. Municipal water treatment practices are also likely to eliminate
any residues in drinking water. Even if dietary and non-occupational
exposures to residues of Pseudomonas oryzihabitans strain SYM23945 were
to occur, there are no risks of concern due to the lack of adverse
effects from toxicity, pathogenicity, or infectivity of Pseudomonas
oryzihabitans strain SYM23945. Because there are no threshold levels of
concern with the toxicity, pathogenicity, or infectivity of Pseudomonas
oryzihabitans strain SYM23945, 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,
which concludes that there are no risks of concern from aggregate
exposure to Pseudomonas oryzihabitans strain SYM23945, 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 Pseudomonas oryzihabitans strain SYM23945.
B. Analytical Enforcement Methodology
An analytical method is not required for Pseudomonas oryzihabitans
strain SYM23945 because EPA is establishing an exemption from the
requirement of a tolerance without any numerical limitation.
C. Response to Comments
The Agency received two identical comments that expressed concern
with Pseudomonas oryzihabitans being a pathogenic bacterium causing
sickness, cancer, and being overall harmful to humans. The Agency's
literature review showed that rare cases of human infection have been
documented with Pseudomonas oryzihabitans in immunocompromised
individuals and/or individuals that have experienced injury or recent
medical procedure. No instances of human infection have been documented
for Pseudomonas oryzihabitans strain SYM23945. Additionally, EPA
concluded that Pseudomonas oryzihabitans strain SYM23945 is not toxic,
pathogenic, and/or infective to mammals. The Agency has evaluated the
aggregate risk of Pseudomonas oryzihabitans strain SYM23945 and has
determined that there is a reasonable certainty that no harm will
result to the general population, or to infants and children from
aggregate exposure to residues of Pseudomonas oryzihabitans strain
SYM23945. The Agency is aware of no evidence indicating that
Pseudomonas oryzihabitans strain SYM23945 is carcinogenic. The comments
offered no relevant information that would warrant a reconsideration of
the Agency's determination.
D. Revisions to the Requested Tolerance Exemption
The petition requested an exemption from the requirement of a
tolerance for residues of the nematicide Pseudomonas oryzihabitans
strain SYM23945 in or on all food commodities. The Agency has omitted
the term ``nematicide'' from the exemption established in this action
to reduce any unnecessary restrictions therein.
E. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of Pseudomonas oryzihabitans strain SYM23945
in or on all food commodities when used in accordance with label
directions and good agricultural practices.
[[Page 13840]]
IV. 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/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-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. 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.
C. 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.
D. 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.
E. 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.
F. 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.
G. 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 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.
H. 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.
I. 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.
J. 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: March 19, 2025.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, the 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. 180.1416 to subpart D to read as follows:
Sec. 180.1416 Pseudomonas oryzihabitans strain SYM23945; exemption
from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Pseudomonas oryzihabitans strain SYM23945 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.
[FR Doc. 2025-05173 Filed 3-26-25; 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.