Rule2026-16120
Bacillus thuringiensis eCry1Gb.1Ig Protein; Exemption From the Requirement of a Pesticide Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 7, 2026
Effective
August 7, 2026
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of Bacillus thuringiensis eCry1Gb.1Ig protein in or on the food and feed commodities of corn, field; corn, sweet; and corn, pop when used as a plant-incorporated protectant (PIP) in corn. Syngenta Seeds, LLC submitted a petition to 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 eCry1Gb.1Ig protein under FFDCA when used in accordance with the terms of the exemption.
Full Text
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<title>Federal Register, Volume 91 Issue 151 (Friday, August 7, 2026)</title>
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[Federal Register Volume 91, Number 151 (Friday, August 7, 2026)]
[Rules and Regulations]
[Pages 51068-51071]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-16120]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2025-0047; FRL-13446-01-OCSPP]
Bacillus thuringiensis eCry1Gb.1Ig Protein; Exemption From the
Requirement of a Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Bacillus thuringiensis eCry1Gb.1Ig
protein in or on the food and feed commodities of corn, field; corn,
sweet; and corn, pop when used as a plant-incorporated protectant (PIP)
in corn. Syngenta Seeds, LLC submitted a petition to 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
eCry1Gb.1Ig protein under FFDCA when used in accordance with the terms
of the exemption.
DATES: This rule is effective on August 7, 2026. Objections and
requests for hearings must be received on or before October 6, 2026,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of this document).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2025-0047, is available online 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 center in-
person, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Shannon Borges, Biopesticides and
Pollution Prevention Division (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#fab8aaaabebca8b4958e93999f89ba9f8a9bd49d958c"><span class="__cf_email__" data-cfemail="9cdeccccd8daced2f3e8f5fff9efdcf9ecfdb2fbf3ea">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive 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:
<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-
2025-0047 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, 2026.
EPA's Administrative Law Judges Division (ALJD), in which the
Hearing Clerk is housed, urges parties to file and serve documents by
electronic means only, notwithstanding any other particular
requirements set forth in other procedural rules governing those
proceedings. See ``Order Urging Electronic Filing and Service,'' dated
December 3, 2025, which can be found at <a href="https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf">https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf</a>. Although EPA's regulations require submission via U.S.
Mail or hand delivery, EPA intends to treat submissions filed via
electronic means as properly filed submissions; therefore, EPA believes
the preference for submission via electronic means will not be
prejudicial. When submitting documents to the OALJ electronically, a
person should utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf">https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf</a>.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow
the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute. If you wish to
include CBI in your request, please follow the applicable instructions
at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly
mark the information that you claim to be CBI. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice.
II. Petitioned for Exemption
In the Federal Register of April 7, 2025 (90 FR 14954) (FRL-12474-
01-OSCPP), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a, announcing the filing of a pesticide tolerance petition
(PP 4F9142) by Syngenta Seeds, LLC, 9 Davis Drive,
[[Page 51069]]
Research Triangle Park, NC 27709. The petition requested that 40 CFR
part 174 be amended by establishing an exemption from the requirement
of a tolerance for residues of the insecticidal PIP Bacillus
thuringiensis eCry1Gb.1Ig protein and the genetic material (vector
pSYN24795) necessary for its production in MZIR260 Corn (SYN-
[Oslash][Oslash]260[Oslash]-3) in or on corn, field; corn, sweet; and
corn, pop. That document referenced a summary of the petition prepared
by the petitioner Syngenta Seeds, LLC, which is available in the
docket. Two comments were received on the notice of filing. EPA's
responses to these comments are discussed in Unit III.C.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is not establishing a new tolerance exemption for residues of the
genetic material (vector pSYN24795), because such residues are covered
by the existing tolerance exemption at 40 CFR 174.507.
III. Final Tolerance Actions
A. EPA's Safety Determination
EPA evaluated the available toxicological and exposure data for
Bacillus thuringiensis eCry1Gb.1Ig protein 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 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 Ingredient, eCry1Gb.1Ig, and the Genetic Material
Necessary (pSYN24795) for its Production in Event MZIR260 maize (OECD
Unique Identifier: SYN-[Oslash][Oslash]26[Oslash]-3 and Establishment
of a Permanent Tolerance Exemption for Residues of this Protein When
Used as a Plant-Incorporated Protectant in Maize.'' (Human Health Risk
Assessment). This document, as well as other relevant information, is
available in the docket for this action as described under ADDRESSES.
eCry1Gb.1Ig is a chimeric protein that is composed of three
specific domains from insecticidal Cry proteins derived from the soil
bacterium Bacillus thuringiensis (Bt). It is active against fall
armyworm, a lepidopteran pest of corn. The mode of action of
eCry1Gb.1Ig is equivalent to other Cry proteins, i.e., upon ingestion,
insecticidal Cry proteins are proteolytically activated in the insect
gut and bound to unique receptors, leading to membrane pore formation
in the midgut cells and ultimately insect death. However, eCry1Gb.1Ig
is unique, in that it has a different binding receptor on the midgut
cell surface than other Cry proteins and therefore confers insecticidal
efficacy against traditionally Cry-resistant lepidopterans.
As discussed in the Human Health Risk Assessment, available data
demonstrate that, with regard to humans, the eCry1Gb.1Ig protein is
unlikely to be toxic to humans and has a low potential for
allergenicity. This general conclusion is supported for eCry1Gb.1Ig by
acute oral toxicity studies, which showed no toxicity to CD-1 mice
after exposure to two oral doses totaling 2,000 mg/kg. Therefore, the
protein is unlikely to be toxic to mammals at a level above maximum
possible dietary exposures that are reasonably anticipated from
consumption of the crop expressing the PIP. In addition, bioinformatic
searches using the amino acid sequence of the protein showed no
biologically relevant matches to known toxins. Similarly, data and
information provided by the petitioner demonstrated that the likelihood
that eCry1Gb.1Ig is a food allergen is minimal. The eCry1Gb.1Ig protein
was not found to share amino acid sequence homology with known
allergens, was rapidly digested in simulated gastric fluids, did not
exhibit resistance to heat treatment, and was not found to be
glycosylated. As such, there is no indication that eCry1Gb.1Ig protein
would elicit dietary allergic reactions.
Exposure to eCry1Gb.1Ig through the dietary route is expected to
occur through ingestion of corn plants expressing the protein. However,
exposure to this protein is not expected to result in a human health
risk given the lack of oral toxicity and allergenicity as described
above. Oral exposure from ingestion of drinking water is unlikely
because the eCry1Gb.1Ig protein is expressed within the plant cells,
and as such is susceptible to degradation by environmental conditions
and microbial activity. In the unlikely event that eCry1Gb.1Ig protein
were to enter drinking water, exposure to this protein would not be
expected to result in a human health risk given the lack of oral
toxicity and allergenicity as described above.
As a PIP, eCry1Gb.1Ig is contained within the plant cells;
therefore, non-occupational and residential exposure is considered to
be negligible.
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 eCry1Gb.1Ig protein.
As a result, an additional margin of safety for the protection of
infants and children is unnecessary.
B. Analytical Enforcement Methodology
An analytical method is not required for eCry1Gb.1Ig protein
because EPA is establishing an exemption from the requirement of a
tolerance without any numerical limitation. However, the petitioner
developed an immunoassay method for detection of the eCry1Gb.1Ig
protein in MZIR260 corn tissues.
C. Response to Comments
EPA received two comments during the public comment period for the
notice of filing. Both commenters urged the Agency to assess the long-
term effects of Bt PIPs and genetically modified plants on human
health. In response, EPA notes that pesticides derived from Bt,
including microbial and PIP applications, have a long history of safe
use for over 50 years in agriculture, and no naturally occurring Cry
protein from Bt has been identified as a known mammalian toxin or
allergen to date. Further, the Agency has conducted a comprehensive
human health risk assessment for the eCry1Gb.1Ig protein and, as
described in this Unit III and in the Human Health Risk Assessment, no
adverse effects of concern have been identified.
One commenter also raised concerns about whether approval of
eCry1Gb.1Ig would ``compromise the precautionary principle that . . .
approvals often move forward before comprehensive, independent studies
have fully evaluated the cumulative exposure risks or potential
synergistic effects of multiple pesticide residues.'' EPA follows a
well-established risk evaluation process for pesticides (<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>). As described in this Unit III and
in the Human Health Risk Assessment, EPA does consider cumulative and
aggregate exposures, including potential impacts on sensitive
subpopulations. Pesticides with dietary exposure must meet the safety
standard under section 408 of the FFDCA 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.'' As
described in this Unit III, EPA has determined that
[[Page 51070]]
the eCry1Gb.1Ig protein meets the FFDCA standard.
The commenter also raised concerns about ecological consequences
for pollinators, soil, and water systems. Such considerations are not
relevant to the Agency's evaluation of safety under the FFDCA standard,
which requires the Agency to evaluate the potential harms to human
health, not effects on the environment. However, ecological risks are
evaluated under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). The ecological risk assessment for the eCry1Gb.1Ig protein is
posted in the docket for the FIFRA registration action, docket ID
number EPA-HQ-OPP-2025-0048, at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, and it
details the Agency's conclusions of a lack of risk of the eCry1Gb.1Ig
protein to pollinators and the lack of environmental persistence of the
protein in soil and water systems.
D. Conclusion
Based upon its evaluation described above and in the Human Health
Risk Assessment, which concluded that eCry1Gb.1Ig protein residues in
or on corn are not toxic or allergenic to mammals, 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 Bacillus thuringiensis eCry1Gb.1Ig protein. Therefore, an
exemption from the requirement of a tolerance is established for
residues of Bacillus thuringiensis eCry1Gb.1Ig protein in or on the
food and feed commodities of corn, field; corn, sweet; and corn, pop
when used as a plant-incorporated protectant in corn.
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 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
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 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.
[[Page 51071]]
Dated: August 2, 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
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.
Subpart W--Tolerances and Tolerance Exemptions
0
2. Add Sec. 174.560 to Subpart W to read as follows:
Sec. 174.560 Bacillus thuringiensis eCry1Gb.1Ig protein; exemption
from the requirement of a tolerance.
Residues of Bacillus thuringiensis eCry1Gb.1Ig protein in or on the
food and feed commodities of corn, field; corn, sweet; and corn, pop
are exempt from the requirement of a tolerance when used as a plant-
incorporated protectant in corn.
[FR Doc. 2026-16120 Filed 8-6-26; 8:45 am]
BILLING CODE 6560-50-P
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