Rule2025-14887
Bacillus thuringiensis Cry1A.2 and Cry1B.2 Proteins; Exemptions 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
August 6, 2025
Effective
August 6, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes exemptions from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry1A.2 and Cry1B.2 proteins (hereafter Cry1A.2 and Cry1B.2 proteins) in or on the food and feed commodities of soybean when used as plant-incorporated protectants (PIP) in soybean. Bayer CropScience LP submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting these exemptions. This regulation eliminates the need to establish a maximum permissible level for residues of these pesticides when used in accordance with the terms of the exemption.
Full Text
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<title>Federal Register, Volume 90 Issue 149 (Wednesday, August 6, 2025)</title>
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[Federal Register Volume 90, Number 149 (Wednesday, August 6, 2025)]
[Rules and Regulations]
[Pages 37797-37800]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14887]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2024-0293; FRL-12818-01-OCSPP]
Bacillus thuringiensis Cry1A.2 and Cry1B.2 Proteins; Exemptions
From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of the Bacillus thuringiensis Cry1A.2 and
Cry1B.2 proteins (hereafter Cry1A.2 and Cry1B.2 proteins) in or on the
food and feed commodities of soybean when used as plant-incorporated
protectants (PIP) in soybean. Bayer CropScience LP submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting these exemptions. This regulation eliminates the need to
establish a maximum permissible level for residues of these pesticides
when used in accordance with the terms of the exemption.
DATES: This regulation is effective on August 6, 2025. Objections and
requests for hearings must be received on or before October 6, 2025,
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-2024-0293, is available at <a href="http://www.regulations.gov">http://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: 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:
<a href="/cdn-cgi/l/email-protection#7d3f2d2d393b2f331209141e180e3d180d1c531a120b"><span class="__cf_email__" data-cfemail="4d0f1d1d090b1f032239242e283e0d283d2c632a223b">[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 applies 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 docket ID number EPA-HQ-OPP-
2024-0293 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 6, 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
[[Page 37798]]
person should utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/OA/EAB/EABALJupload.nsf">https://yosemite.epa.gov/OA/EAB/EABALJupload.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 August 8, 2024 (89 FR 64842) (FRL-11682-
06-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 3F9096) by Bayer CropScience LP, 800 N Lindbergh Blvd.,
St. Louis, Missouri 63167. The petition requested that 40 CFR part 174
be amended by establishing an exemption from the requirement of a
tolerance for residues of the plant-incorporated protectants (PIPs)
Bacillus thuringienisis Cry1A.2 and Bacillus thuringienisis Cry1B.2 in
or on soybean. That document referenced a summary of the petition
prepared by the petitioner Bayer Crop Science LP, which is available in
the docket. There was one comment received in response to the notice of
filing. EPA's response to this comment is discussed in Unit III.C.
III. Final Tolerance Actions
A. EPA's Safety Determination
EPA evaluated the available toxicity and exposure data on Cry1A.2
and Cry1B.2 proteins and considered their validity, completeness, and
reliability, as well as the relationship of this information 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. A summary of the data upon
which EPA relied and its risk assessment based on those data can be
found within the document entitled ``Product Characterization Review
and Human Health Risk Assessment of the Insecticidal Plant-Incorporated
Protectant Active Ingredients, Cry1A.2 and Cry1B.2, and the Genetic
Material Necessary (PV-GMIR527237) for their Production in Event MON
94637 Soybean (OECD Unique Identifier: MON 94637-8), and Establishment
of a Permanent Tolerance Exemption for Residues of these Proteins When
Used as a Plant Incorporated Protectant in Soybean. Data Were Provided
in Support of a FIFRA Section 3 Seed Increase Registration'' (Human
Health Risk Assessment). This document, as well as other relevant
information, is available in the docket for this action as described
under ADDRESSES.
Cry1A.2 is a modified protein derived from the bacterium Bacillus
thuringiensis (Bt) and is active against certain lepidopteran pests of
soybean. As discussed in the Human Health Risk Assessment, available
data demonstrated that, with regard to humans, the Cry1A.2 protein does
not pose a toxic risk to humans and has a low risk of allergenicity.
Cry proteins, such as Cry1A.2, have specific activity limited to
certain insect orders due to the alkaline environment found in the
insect midgut and the presence of specific receptors in the insect gut
to which activated Cry proteins bind. Upon ingestion of the protein by
the insect, the Cry protein is proteolytically activated by the
alkaline environment, where it binds to membrane receptors in the
midgut epithelium and then oligomerizes to form pores in the membrane,
resulting in ion imbalance and ultimately death of the insect. Unlike
insects, the human gut environment is highly acidic and contains
proteases which facilitate protein degradation rather than protein
activation. In addition, there are no known equivalent insecticidal Cry
protein receptor sites in mammalian species which could be affected.
This general expectation is supported for Cry1A.2 by the results of an
acute oral toxicity study in which the oral LD<INF>50</INF> of Cry1A.2
in mice was determined to be greater than 5,000 mg/kg body weight,
indicating a lack of toxicity at a level well above maximum possible
dietary exposure levels that are reasonably anticipated from
consumption of the crop. In addition, a bioinformatics analysis of the
primary protein sequence did not identify any significant homologies of
the Cry1A.2 protein to known mammalian toxins. Likewise, the potential
for allergenicity is low because: (1) the bacterial source of the
Cry1A.2 protein, Bt, is ubiquitous in the environment, has a long
history of safe use in agriculture, and no Cry protein produced by Bt
is known to be an allergen; (2) bioinformatic analyses indicate no
biologically relevant similarity between the Cry1A.2 protein and any
known allergens; (3) the Cry1A.2 protein degrades rapidly when exposed
to digestive enzymes (gastric proteases) present in the human
gastrointestinal tract; (4) the Cry1A.2 protein shows loss of function
under high temperatures (>=75 [deg]C), indicating that it is heat
labile and will likely denature in the course of normal thermal
treatment during food preparation; and (5) the Cry1A.2 protein is not
glycosylated, which further reduces its allergenicity potential.
Glycosylation is an enzymatic post-translational process in which
carbohydrates (glycans) link to proteins, creating structures which
could lead to an immune response in humans.
The most likely route of exposure to this plant-incorporated
protectant is dietary, via consumption of products produced from
soybean expressing the Cry1A.2 protein. Oral exposure from ingestion of
drinking water is unlikely because the Cry1A.2 protein is present
within the plant cells, and as such they are susceptible to degradation
by environmental conditions and microbial activity. In the unlikely
event that Cry1A.2 protein were to enter drinking water, exposure to
this protein would not expect to result in a human health risk given
the lack of toxicity and allergenicity as described above.
The Cry1A.2 protein is not proposed for use in any residential
settings and as a plant-incorporated protectant, Cry1A.2 is contained
within the plant cells and as such, non-occupational and residential
exposure is considered to be negligible. The human health safety
findings summarized above are discussed in more detail in the Human
Health Risk Assessment. Cry1B.2 is also derived from the bacterium Bt
and is active against certain lepidopteran pests of soybean. Available
data demonstrated that, with regard to humans, the Cry1B.2 protein does
not pose a toxic risk to humans and has a low risk of allergenicity.
Like Cry1A.2, Cry1B.2 is a Cry protein with activity specific to
certain insect orders through a midgut receptor-mediated mode of
action. As described above, effects to humans are not expected since
humans lack Bt receptors and the gut conditions necessary to activate
Cry proteins. This general expectation is supported for Cry1B.2 by the
results of an acute oral toxicity study in which the oral
LD<INF>50</INF> of Cry1B.2 in mice was determined to be greater than
5,000 mg/kg body weight, indicating a lack of toxicity at a level well
above maximum possible exposure levels that are reasonably anticipated
for the crop. In addition, a bioinformatics
[[Page 37799]]
analysis of the primary protein sequence did not identify any
significant homologies of the Cry1B.2 protein to known mammalian
toxins. Likewise, the potential for allergenicity is low because: (1)
the bacterial source of the Cry1B.2 protein, Bt, is ubiquitous in the
environment has a long history of safe use, including use as a
pesticide, and no Cry protein produced by Bt is known to be an
allergen; (2) bioinformatic analyses indicate no biologically relevant
similarity between the Cry1B.2 protein and any known allergens; (3) the
Cry1B.2 protein degrades rapidly when exposed to digestive enzymes
(gastric proteases) present in the human gastrointestinal tract; (4)
the Cry1B.2 protein shows loss of function under high temperatures
(>=75 [deg]C), indicating that it is heat labile and will likely
denature in the course of normal thermal treatment during food
preparation; and (5) the Cry1B.2 protein is not glycosylated, which
further reduces its allergenicity potential. Glycosylation is an
enzymatic post-translational process in which carbohydrates (glycans)
link to proteins, creating structures which could lead to an immune
response in humans.
The most likely route of exposure to this plant-incorporated
protectant is dietary, via products produced from soybean expressing
the protein. Oral exposure from ingestion of drinking water is unlikely
because the Cry1B.2 protein is present within the plant cells, and as
such they are susceptible to degradation by environmental conditions
and microbial activity. In the unlikely event that Cry1B.2 protein were
to enter drinking water, exposure to this protein would not expect to
result in a human health risk given the lack of toxicity and
allergenicity as described above.
The Cry1A.2 protein is not proposed for use in any residential
settings and as a plant-incorporated protectant, Cry1B.2 is contained
within the plant cells and as such, non-occupational and residential
exposure is considered to be negligible. The human health safety
findings summarized above are discussed in more detail in the Human
Health Risk Assessment.
Section 408(b)(2)(D)(v) of FFDCA 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.'' No risk of cumulative toxicity or
effects from the Cry1A.2 protein has been identified as no toxicity or
allergenicity has been shown for this protein in the submitted studies.
Therefore, EPA has concluded that the Cry1A.2 protein does not have a
common mechanism of toxicity with other substances. Similarly, no risk
of cumulative toxicity or effects from the Cry1B.2 protein has been
identified as no toxicity or allergenicity has been shown for this
protein in the submitted studies. Therefore, EPA has concluded that the
Cry1B.2 protein does not have a common mechanism of toxicity with other
substances.
Although FFDCA section 408(b)(2)(C) provides for an additional
tenfold margin of safety for infants and children in the case of
threshold effects, EPA has determined that there are no such effects
due to the lack of toxicity of the Cry1A.2 protein. Because there are
no threshold levels of concern to infants, children, and adults, EPA
concludes that no additional margin of safety is necessary to protect
infants and children. Similarly, EPA has determined that there are no
such effects due to the lack of toxicity of the Cry1B.2 protein.
Because there are no threshold levels of concern to infants, children,
and adults, EPA concludes that no additional margin of safety is
necessary to protect infants and children.
Based upon its evaluation described above and in the Human Health
Risk Assessment, 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 the Cry1A.2 protein
derived from the bacterium Bacillus thuringiensis (Bt). Therefore, an
exemption from the requirement of a tolerance is established for
residues of the Cry1A.2 protein in or on the food and feed commodities
of soybean when used as a plant-incorporated protectant in soybean.
Similarly, based upon its evaluation described above and in the Human
Health Risk Assessment, 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 the
Cry1B.2 protein derived from the bacterium Bacillus thuringiensis (Bt).
Therefore, an exemption from the requirement of a tolerance is
established for residues of the Cry1B.2 protein in or on the food and
feed commodities of soybean when used as a plant-incorporated
protectant in soybean.
B. Analytical Enforcement Methodology
EPA has determined that analytical methods are not required for
enforcement purposes since the there is no need to monitor residues due
to a lack of safety concerns. Nonetheless, a method was submitted for
an enzyme-linked immunosorbent assay (ELISA) to detect the presence of
Cry1A.2 and Cry1B.2 proteins in flower, forage, and grain tissues and
could serve as the analytical method for these PIPs.
C. Response to Comment
One comment was received during the public comment period for the
notice of filing. The commentor provided general objections to EPA
establishing exemptions from tolerances for pesticides but did not
provide any specific or substantive objections to the petition for
tolerance exemptions of the Cry1A.2 and Cry1B.2 proteins. Based on its
review of the data and other information submitted in support of the
tolerance exemption petition (as described above in Unit III.A), EPA
has determined that a tolerance exemption for Cry1A.2 and Cry1B.2
proteins, when used as plant-incorporated protectants, is safe under
the FFDCA. Therefore, EPA is establishing an exemption from the
requirement of a tolerance for residues of Cry1A.2 and Cry1B.2 proteins
in or on the food and feed commodities of soybean.
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.
[[Page 37800]]
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 2021 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 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 174
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 29, 2025.
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 174--PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED
PROTECTANTS.
0
1. authority citation for part 174 continues to read as follows:
Authority: 7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.
0
2. Add Sec. Sec. 174.554 and 174.555 to subpart W to read as follows:
Sec. 174.554 Bacillus thuringiensis Cry1A.2 protein; exemption from
the requirement of a tolerance.
Residues of Bacillus thuringiensis Cry1A.2 protein in or on the
food and feed commodities of soybean are exempt from the requirement of
a tolerance when used as a plant-incorporated protectant in soybean.
Sec. 174.555 Bacillus thuringiensis Cry1B.2 protein; exemption from
the requirement of a tolerance.
Residues of Bacillus thuringiensis Cry1B.2 protein in or on the
food and feed commodities of soybean are exempt from the requirement of
a tolerance when used as a plant-incorporated protectant in soybean.
[FR Doc. 2025-14887 Filed 8-5-25; 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.