Rule2026-10709
Bacillus Thuringiensis Cry1B.34.1, Bacillus Thuringiensis Cry1B.61.1 and Adiantum Trapeziforme var. Braziliense IPD083Cb Proteins; Pesticide Tolerances
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
May 29, 2026
Effective
May 29, 2026
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes exemptions from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry1B.34.1, Bacillus thuringiensis Cry1B.61.1, and Adiantum trapeziforme var. braziliense IPD083Cb proteins (hereafter Cry1B.34.1, Cry1B.61, and IPD083Cb proteins) in or on all food and feed commodities when used as plant-incorporated protectants (PIP). Pioneer Hi-Bred International Inc. (Pioneer) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting exemptions from the requirement of a tolerance. This regulation eliminates the need to establish maximum permissible levels for residues of Cry1B.34.1, Cry1B.61, and IPD083Cb proteins when used in accordance with the terms of the exemption.
Full Text
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<title>Federal Register, Volume 91 Issue 103 (Friday, May 29, 2026)</title>
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[Federal Register Volume 91, Number 103 (Friday, May 29, 2026)]
[Rules and Regulations]
[Pages 31954-31958]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10709]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2025-0089; EPA-HQ-OPP-2025-0099; EPA-HQ-OPP-2025-0100; FRL-
13294-01-OCSPP]
Bacillus Thuringiensis Cry1B.34.1, Bacillus Thuringiensis
Cry1B.61.1 and Adiantum Trapeziforme var. Braziliense IPD083Cb
Proteins; Pesticide Tolerances
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 Cry1B.34.1,
Bacillus thuringiensis Cry1B.61.1, and Adiantum trapeziforme var.
braziliense IPD083Cb proteins (hereafter Cry1B.34.1, Cry1B.61, and
IPD083Cb proteins) in or on all food and feed commodities when used as
plant-incorporated protectants (PIP). Pioneer Hi-Bred International
Inc. (Pioneer) submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting exemptions from the
requirement of a tolerance. This regulation eliminates the need to
establish maximum permissible levels for residues of Cry1B.34.1,
Cry1B.61, and IPD083Cb proteins when used in accordance with the terms
of the exemption.
DATES: This regulation is effective on May 29, 2026. Objections and
requests for hearings must be received on or before July 28, 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 dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPP-2025-0089, EPA-HQ-OPP-2025-0099,
and EPA-HQ-OPP-2025-0100 are available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Additional information about the docket 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>.
[[Page 31955]]
FOR FURTHER INFORMATION CONTACT: Shannon Borges, Biopesticides and
Pollution Prevention Division (7511P), 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#df9d8f8f9b998d91b0abb6bcbaac9fbaafbef1b8b0a9"><span class="__cf_email__" data-cfemail="5f1d0f0f1b190d11302b363c3a2c1f3a2f3e71383029">[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, 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 numbers EPA-HQ-OPP-
2025-0089, EPA-HQ-OPP-2025-0099, and EPA-HQ-OPP-2025-0100, 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 July 28, 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 Exemptions
In the Federal Register of September 5, 2025 (90 FR 42896) (FRL-
12474-06-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide
tolerance petitions (PP 4F9125, 4F9126, and 4F9127) by Pioneer Hi-Bred
International Inc.,7300 NW 62nd Avenue, P.O. Box Johnston, Iowa 50131.
The petition requested that 40 CFR part 174 be amended by establishing
exemptions from the requirement of a tolerance for residues of the
Bacillus thuringiensis Cry1B.34.1, Bacillus thuringiensis Cry1B.61.1,
and Adiantum trapeziforme var. braziliense IPD083Cb proteins in or on
all food and feed commodities when used as plant incorporated
protectants (PIP). That document referenced a summary of the petitions
submitted by the petitioner Pioneer, which is available in the dockets.
One comment was received on the notice of filing. EPA's response to
the comment is discussed in Unit III.C.
III. Final Tolerance Actions
A. EPA's Safety Determination
EPA evaluated the available toxicological and exposure data on the
Cry1B.34.1, Cry1B.61.1, and IPD083Cb proteins 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 ``Product Characterization Review
and Human Health Risk Assessment of the Insecticidal Plant-Incorporated
Protectant (PIP) Active Ingredients Cry1B.34.1, Cry1B.61.1, and
IPD083Cb, the PIP Inert Ingredient GM-HRA, and the Genetic Material
Necessary (PHP90315 T-DNA) for their Production in Event COR23134
Soybean (OECD Unique Identifier: COR-23134-4)'' (Human Health Risk
Assessment). This document, as well as other relevant information, are
available in the docket
[[Page 31956]]
for this action as described under ADDRESSES.
Cry1B.34.1 and Cry1B.61.1 are both derived from the bacterium
Bacillus thuringiensis (Bt) and IPD083Cb is derived from Adiantum
trapeziforme var. braziliense (maidenhair fern). All three of these
PIPs are intended to provide protection from feeding damage caused by
certain lepidopteran insect pests. Similar to other insecticidal
crystal proteins derived from Bt, the pesticidal mode of action
effected by both Cry1B.34.1 and Cry1B.61.1 is pore formation in the
midgut of the target pest leading to death. The Cry1B.34.1 protein in
soybean was determined to be identical to the Cry1B.34 active
ingredient in maize, for which an exemption from tolerance was
previously established (40 CFR 174.553). The three-domain core of
Cry1B.34.1 is intact and as such is expected to exhibit the mode of
action and activity spectrum of Cry1B.34 in maize. Cry1B.61.1 is a
modified Cry1B-class protein with changes introduced into the amino
acid sequence to improve effectiveness against the target pests. The
IPD083Cb protein is a fern-derived insecticidal protein whose mode of
action is expected to be similar to that of the Bt Cry proteins.
Characterization of fern-derived IPD proteins found that, while they
share no significant sequence homology to Cry proteins, they do exhibit
high structural and functional similarity to domains I and II of the
tryptic core of three-domain Cry proteins, and the insecticidal
activity was found to be specific to lepidopteran pests.
The most likely route of exposure to these plant-incorporated
protectants are dietary, via consumption of food plants producing the
three PIPs. However, Cry1B.34.1, Cry1B.61.1, and IPD083Cb are expected
to be of negligible toxicity and are unlikely to be food allergens. The
lack of toxicity is due to: (1) the results of the acute oral toxicity
studies, which showed no toxicity to mice after exposure to three oral
doses totaling 5000 mg/kg/bw (EPA Toxicity Category IV); and (2)
bioinformatic analyses of the proteins that showed none of Cry1B.34.1
and Cry1B.61.1 of IPD083Cb were found to exhibit significant homology
to any known mammalian toxins. Likewise, the potential for
allergenicity is low because: (1) bioinformatic analyses indicate no
biologically relevant similarity between the Cry1B.34.1, Cry1B.61.1,
and IPD083Cb proteins and any known allergens; (2) Cry1B.34.1,
Cry1B.61.1, and IPD083Cb proteins were fully and rapidly digested when
exposed to digestive enzymes (gastric proteases); (3) Cry1B.34.1,
Cry1B.61.1, and IPD083Cb proteins behave with a predictable tendency
toward protein denaturation and loss of functional activity at elevated
temperatures, indicating that they are heat labile and will likely
denature in the course of normal thermal treatment during food
preparation; and (4) Cry1B.34.1, Cry1B.61.1, and IPD083Cb proteins are
not glycosylated. Current scientific knowledge suggests that protein
glycosylation may contribute to protein stability and enhance its
allergenic potential.
Oral exposure to the Cry1B.34.1, Cry1B.61.1, and IPD083Cb proteins
via drinking water is considered unlikely. Cry1B.34.1, Cry1B.61.1, and
IPD083Cb are proteins and, as such, they are susceptible to degradation
by environmental conditions and microbial activity. Therefore, the
expectation is that these proteins would be broken down into their
amino acid constituents before they could reach drinking water.
However, in the unlikely event that Cry1B.34.1, Cry1B.61.1, or IPD083Cb
are present in drinking water, exposure to these proteins would not be
expected to result in a human health risk based on the hazard
considerations articulated above.
As plant-incorporated protectants, Cry1B.34.1, Cry1B.61.1, and
IPD083Cb are contained within the plant cells. Therefore, non-
occupational and residential exposure is considered to be negligible
except for oral exposure through consumption of the plant expressing
those proteins.
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 and allergenicity of Cry1B.34.1,
Cry1B.61.1, and IPD083Cb proteins. As a result, an additional margin of
safety for the protection of infants and children is unnecessary.
Based upon its evaluation in the Human Health Risk Assessment,
which concluded that Bacillus thuringiensis Cry1B.34.1, Bacillus
thuringiensis Cry1B.61.1, and Adiantum trapeziforme var. braziliense
IPD083Cb proteins are not toxic or allergenic to mammals, 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 Cry1B.34.1, Cry1B.61.1, and IPD083Cb proteins.
Therefore, exemptions from the requirement of a tolerance are
established for residues of Bacillus thuringiensis Cry1B.34.1, Bacillus
thuringiensis Cry1B.61.1, and Adiantum trapeziforme var. braziliense
IPD083Cb proteins in or on all food and feed commodities when used as
plant-incorporated protectants and according to the label and good
agricultural practices.
B. Analytical Enforcement Methodology
EPA has determined that an analytical method is not required for
enforcement purposes for Cry1B.34.1, Cry1B.61.1, and IPD083Cb residues
since the Agency is establishing exemptions from the requirement of a
tolerance without any numerical limitation. Nonetheless, a valid
enzyme-linked immunosorbent assay (ELISA) to detect the presence of.
Cry1B.34.1, Cry1B.61.1, and IPD083Cb proteins in extracts from
different plant parts were submitted with the petitions. The submitted
ELISA methodology was determined to be a reliable method of detecting
Cry1B.34.1, Cry1B.61.1, and IPD083C proteins in the tissues of soybean.
C. Response to Comments
One comment was received during the public comment period for the
notice of filing. The commentor urged the prohibition of PIPs and
``manipulated nucleic acids (MNAs)'' citing potential health and
environmental impacts due to the gene flow (integration) of the
modified genetic material from PIPs into other organisms, particularly
microbes and marine fauna. EPA's assessments for PIP active ingredients
have concluded that there is no evidence that the transfer of PIP genes
and/or toxins to microorganisms or other fauna can occur. Furthermore,
experiments published in the scientific literature have been unable to
detect PIP gene transfer under typical environmental conditions.
Regarding the Cry1B.34.1, Cry1B.61.1, and IPD083C proteins, EPA has
performed two in-depth assessments to ascertain the overall risk to
human health and the environment. As described in Part III.A above,
these PIPs are expected to be of negligible mammalian toxicity and are
unlikely to be food allergens. Therefore, no adverse effects to human
health are expected when Cry1B.34.1, Cry1B.61.1, and IPD083Cb are
expressed as a PIP in food and feed commodities. Further, an ecological
risk and environmental fate assessment was conducted to determine the
risk to terrestrial and aquatic non-target organisms. The results of
this assessment determined that the three PIPs are not expected to pose
a hazard to any non-target, non-lepidopteran organisms, including non-
lepidopteran marine fauna such as fish and invertebrates, due to the
proteins' lack
[[Page 31957]]
of activity against non-insect species. Furthermore, exposure to these
proteins is anticipated to be limited as off-field dispersal of the PIP
pollen and post-harvest residues would result in negligible exposures
levels of Cry1B.34.1, Cry1B.61.1, and IPD083Cb to marine environments.
Therefore, due to a lack of hazard and/or relevant environmental
exposure, there is a reasonable expectation of no discernible effects
to occur to marine fish or invertebrate species.
D. Conclusion
Therefore, EPA is finalizing the tolerance exemption that was
petitioned for by Pioneer (PP 4F9125 2025-0099) (PP 4F9126 2025-0100)
(PP 4F9127 2025-0089).
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/regulations/and-executive-orders">https://www.epa.gov/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 or tolerance exemption under
FFDCA section 408 are exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the PRA, 44 U.S.C. 3501 et seq., because it does not contain any
information collection activities.
D. Regulatory Flexibility Act (RFA)
This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA
applies only to rules subject to notice and comment rulemaking
requirements under the Administrative Procedure Act (APA), 5 U.S.C.
553, or any other statute. This rule is not subject to the APA but is
subject to FFDCA section 408(d), which does not require notice and
comment rulemaking to take this action in response to a petition.
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 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.
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 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: May 26, 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 174--PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED
PROTECTANTS
Subpart W--TOLERANCES AND TOLERANCE EXEMPTIONS
0
1. The 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. 174.557 to Subpart W to read as follows:
Sec. 174.557 Bacillus thuringensis Cry1B.34.1 protein; exemption from
the requirement of a tolerance.
An exemption from the requirement of a tolerance for residues of
Bacillus thuringensis Cry1B.34.1 protein in or on all food and feed
commodities when used as a Plant-Incorporated Protectant in accordance
with label directions and good agricultural practices.
0
3. Add Sec. 174.558 to Subpart W to read as follows:
[[Page 31958]]
Sec. 174.558 Bacillus thuringensis Cry1B.61.1 protein; exemption from
the requirement of a tolerance.
An exemption from the requirement of a tolerance for residues of
Bacillus thuringensis Cry1B.61.1 protein, in or on all food and feed
commodities when used as a Plant-Incorporated Protectant in accordance
with label directions and good agricultural practices.
0
4. Add Sec. 174.559 to Subpart W to read as follows:
Sec. 174.559 Adiantum trapeziforme var. braziliense IPD083Cb protein;
exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance for residues of
Adiantum trapeziforme var. braziliense IPD083Cb protein in or on all
food and feed commodities when used as a Plant-Incorporated Protectant
in accordance with label directions and good agricultural practices.
[FR Doc. 2026-10709 Filed 5-28-26; 8:45 am]
BILLING CODE 6560-50-P
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