Rule2025-02996
Bacillus Thuringiensis Strain EX 297512 in Pesticide Formulations; 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
February 25, 2025
Effective
February 25, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of Bacillus thuringiensis strain EX 297512, when used as an inert ingredient (diluent and/or carrier) in pesticide formulations applied for seed treatment purposes. BASF Corporation, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of B. thuringiensis strain EX 297512, when used in accordance with the terms of this exemption.
Full Text
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<title>Federal Register, Volume 90 Issue 36 (Tuesday, February 25, 2025)</title>
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[Federal Register Volume 90, Number 36 (Tuesday, February 25, 2025)]
[Rules and Regulations]
[Pages 10599-10603]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-02996]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0572; FRL-12526-01-OCSPP]
Bacillus Thuringiensis Strain EX 297512 in Pesticide
Formulations; 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 Bacillus thuringiensis strain EX 297512,
when used as an inert ingredient (diluent and/or carrier) in pesticide
formulations applied for seed treatment purposes. BASF Corporation,
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting establishment of an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of B. thuringiensis
strain EX 297512, when used in accordance with the terms of this
exemption.
DATES: This regulation is effective February 25, 2025. Objections and
requests for hearings must be received on or before April 28, 2025 and
must be
[[Page 10600]]
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-2019-0572, 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 in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, 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: <a href="/cdn-cgi/l/email-protection#5d0f191b0f133229343e382e1d382d3c733a322b"><span class="__cf_email__" data-cfemail="1e4c5a584c50716a777d7b6d5e7b6e7f30797168">[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
proposed action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.
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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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-
2019-0572, 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 April 28, 2025.
EPA's Office of Administrative Law Judges (OALJ), where 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 Service and
Filing'', 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/HomePage?ReadForm">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm</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. 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-2019-0572, online 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. Additional instructions on commenting or visiting the
docket, along with more information about dockets generally, is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Petition for Exemption
In the Federal Register of February 4, 2020 (86 FR 6129, FRL-10003-
17), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11282) by
BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709. The
petition requested that 40 CFR 180.920 be amended by establishing an
exemption from the requirement of a tolerance for residues of Bacillus
thuringiensis strain EX 297512, whole broth when used as an inert
ingredient (diluent and/or carrier) in pesticide formulations for seed
treatments only. That document referenced a summary of the petition
prepared by BASF Corporation, the petitioner, which is available in the
docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
The Agency received one comment opposing the exemption because of a
perception that it is deregulatory and allowing more pollution.
Although the Agency recognizes that some individuals believe that no
residue of pesticide products should be allowed in or on food, the
existing legal framework provided by FFDCA section 408 authorizes the
establishment of pesticide tolerances or exemptions where the Agency
determines that tolerance or exemption meets the safety standard
imposed by the statute. EPA has sufficient data to support a safety
determination for the exemption from the requirement of a tolerance for
B. thuringiensis strain EX 297512. The commenter provided no
information to indicate that the exemption is not safe.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
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
tolerance is ``safe.'' FFDCA section 408(c)(2)(A)(ii) defines ``safe''
to
[[Page 10601]]
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. When making a safety determination for an
exemption for the requirement of a tolerance, FFDCA section
408(c)(2)(B) directs EPA to consider the considerations in FFDCA
section 408(b)(2)(C) and (D). 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 . . . .'' FFDCA section 408(b)(2)(D) lists other
factors for EPA consideration making safety determinations, e.g., the
validity, completeness, and reliability of available data, nature of
toxic effects, available information concerning the cumulative effects
of the pesticide chemical and other substances with a common mechanism
of toxicity, and available information concerning aggregate exposure
levels to the pesticide chemical and other related substances, among
others.
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
safety determination regarding the aggregate exposure for B.
thuringiensis strain EX 297512, including exposure from uses related to
the exemption established by this action. EPA's assessment of aggregate
exposure associated with B. thuringiensis strain EX 297512, follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by B. thuringiensis strain EX 297512, are
discussed in this unit.
All Bacillus thuringiensis strains will generally have some level
of broth residue left in the end-use product. The broth is the food
that the microbes use for growth and is needed to make (i.e., ferment)
the bacteria. B. thuringiensis strain EX 297512 consists of the
microbial strain B. thuringiensis EX 297512, as well as the spent
fermentation broth and nutrients. ``Bacillus thuringiensis fermentation
solids and/or solubles'' are exempt under 40 CFR 180.910, when used as
a ``diluent, carrier''; therefore, this exemption is for the B.
thuringiensis strain EX 297512.
B. thuringiensis strain EX 297512 is an engineered microbial strain
derived from another B. thuringiensis strain, which was transformed
with a plasmid to produce the enzyme beta-1,4-endoglucanase, which
breaks down organic matter in the soil increase the available nutrient
pool when it is expressed on the spore surface of this microbial
strain.
The toxicological database of B. thuringiensis strain EX 297512 is
supported by data regarding B. thuringiensis strain EX 297512, and data
on B. thuringiensis (Bt), as described in the Bacillus thuringiensis
Reregistration Decision (Bt RED, 1998) for the active ingredient.
Unlike the B. thuringiensis strains registered as active ingredients,
B. thuringiensis strain EX 297512, lacks the plasmids carrying
insecticidal toxins and thus it is an inert ingredient. However, EPA
finds that the data can be bridged, since B. thuringiensis strain EX
297512 satisfies the requirements at 40 CFR 180.1011, such as being
considered an authentic Bt strain and lacking exotoxins.
The available data demonstrates that B. thuringiensis strain EX
297512 exhibits low levels of acute toxicity via the oral, dermal, and
inhalation routes of exposure. It is slightly irritating to the skin
and eyes. Subchronic and chronic is not expected since no toxicological
endpoints were identified for B. thuringiensis strain EX297512 in Tier
I toxicity studies, and no virus contamination is suspected. Moreover,
EPA conducted an allergenicity analysis of the enzyme, which is a
protein, and has determined that the enzyme is not expected to pose any
concern for allergenicity.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program</a>.
The hazard profile of B. thuringiensis strain EX 297512 is
adequately defined. Overall, B. thuringiensis strain EX 297512 is of
low toxicity. Since signs of toxicity or pathogenicity were not
observed, no toxicological endpoints of concern or PODs were
identified. Therefore, a qualitative risk assessment for B.
thuringiensis strain EX 297512 was performed.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to B. thuringiensis strain EX 297512, EPA considered exposure
under
[[Page 10602]]
the proposed exemption from the requirement of a tolerance. EPA
assessed dietary exposures from B. thuringiensis strain EX 297512 in
food as follows:
Dietary exposure (food and drinking water) to B. thuringiensis
strain EX 297512 may occur following ingestion of foods with residues
from their use in accordance with this exemption. However, a
quantitative dietary exposure assessment was not conducted since a
toxicological endpoint for risk assessment was not identified.
2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
B. thuringiensis strain EX 297512 may be present in pesticide and
non-pesticide products that may be used in and around the home.
However, a quantitative residential exposure assessment was not
conducted since a toxicological endpoint for risk assessment was not
identified.
3. Cumulative effects from substances with a common mechanism of
toxicity. FFDCA section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
Based on the lack of toxicity in the available database, EPA has
not found B. thuringiensis strain EX 297512 to share a common mechanism
of toxicity with any other substances, and B. thuringiensis strain EX
297512 does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance exemption, therefore,
EPA has assumed that B. thuringiensis strain EX 297512 does not have a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
D. Safety Factor for the Protection of Infants and Children
FFDCA section 408(b)(2)(C) provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) Safety Factor (SF). In applying this provision, EPA Protection
Act either retains the default value of 10X or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
Based on an assessment of B. thuringiensis strain EX 297512 EPA has
concluded that there are no toxicological endpoints of concern for the
U.S. population, including infants and children. Because there are no
threshold effects associated with B. thuringiensis strain EX 297512,
EPA conducted a qualitative assessment. As part of that assessment, the
Agency did not use safety factors for assessing risk, and no additional
safety factor is needed for assessing risk to infants and children.
E. Aggregate Risks and Determination of Safety
Because no toxicological endpoints of concern were identified, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to B. thuringiensis strain EX 297512 residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. Revisions to Petitioned-For Tolerances
BASF Corporation requested that an exemption from the requirement
of a tolerance be established for residues of ``Bacillus thuringiensis
strain EX 297512 whole broth''. B. thuringiensis strain EX 297512 whole
broth consists of the microbial strain B. thuringiensis EX 297512 as
well as the spent fermentation broth and nutrients. ``Bacillus
thuringiensis fermentation solids and/or solubles'' is exempt under 40
CFR 180.910 when used as a ``diluent, carrier''; therefore, ``whole
broth'' has been removed from the name because an exemption from the
requirement of a tolerance already exists for this component.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for residues of B. thuringiensis
strain EX 297512 when used as an inert ingredient (diluent and/or
carrier) in pesticide formulations applied for seed treatment.
VII. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) 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, 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 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
(PRA) (44 U.S.C. 3501 et seq.).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemptions in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (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, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the National Government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency 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
[[Page 10603]]
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 (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. 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: February 13, 2025.
Charles Smith,
Director, Registration Division, 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. In Sec. 180.920, amend Table 1 to 180.920 by adding, in
alphabetical order, an entry for ``Bacillus thuringiensis strain EX
297512'' to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
Table 1 to Sec. 180.920
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Bacillus thuringiensis strain For seed treatment use Diluent and/or
EX 297512. only. This inert carrier.
ingredient must meet
the specifications
contained in 40 CFR
180.1011(a)(1)-(4).
* * * * * * *
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[FR Doc. 2025-02996 Filed 2-24-25; 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.