Rule2026-06686
Citrus Tristeza Virus (CTV) Strain T36 Expressing Spinach Defensin Proteins SoD2, SoD2-1, and SoD2*; Exemption From the Requirement of a Tolerance
Primary source
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Published
April 7, 2026
Effective
April 7, 2026
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of Citrus tristeza virus (CTV) strain T36 expressing Spinach Defensin Proteins SoD2, SoD2-1, and SoD2* in or on the food and feed commodities of citrus. Silvec Biologics, Inc 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 CTV strain T36 expressing Spinach Defensin Proteins SoD2, SoD2-1, and SoD2* under FFDCA when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 91 Issue 66 (Tuesday, April 7, 2026)</title>
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[Federal Register Volume 91, Number 66 (Tuesday, April 7, 2026)]
[Rules and Regulations]
[Pages 17607-17609]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-06686]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2025-0176; FRL-13258-01-OCSPP]
Citrus Tristeza Virus (CTV) Strain T36 Expressing Spinach
Defensin Proteins SoD2, SoD2-1, and SoD2*; 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 Citrus tristeza virus (CTV) strain T36
expressing Spinach Defensin Proteins SoD2, SoD2-1, and SoD2* in or on
the food and feed commodities of citrus. Silvec Biologics, Inc
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 CTV strain T36 expressing Spinach
Defensin Proteins SoD2, SoD2-1, and SoD2* under FFDCA when used in
accordance with this exemption.
DATES: This regulation is effective April 7, 2026. Objections and
requests for hearings must be received on or before June 8, 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-2025-0176, is 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>.
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#b3f1e3e3f7f5e1fddcc7dad0d6c0f3d6c3d29dd4dcc5"><span class="__cf_email__" data-cfemail="d694868692908498b9a2bfb5b3a596b3a6b7f8b1b9a0">[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 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 number EPA-HQ-OPP-
2025-0176 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 June 8, 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 Exemption
In the Federal Register of July 3, 2025 (90 FR 29516) (FRL-12474-
05-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 4E9114) by Silvec Biologics Inc., 200 Girard
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Street, Suite 200, Gaithersburg, MD 20877. The petition requested that
40 CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for residues of Spinach Defensin Genes 2
(SoD2, SoD2-1, SoD2*), expressed in CTV strain T36 (CTV-SoD2, CTV-SoD2-
1, and CTV-SoD2*) in citrus (Crop Group 10-10). That document
referenced a summary of the petition prepared by the petitioner Silvec
Biologics Inc, which is available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>,
docket ID number EPA-HQ-OPP-2025-0176.
Three comments were received on the notice of filing. All comments
were supportive of a tolerance exemption for CTV-SoD2, CTV-SoD2-1, and
CTV-SoD2* proteins.
III. Final Tolerance Actions
A. EPA's Safety Determination
EPA evaluated the available toxicological and exposure data on CTV
strain T36 expressing Spinach Defensin Protein 2 (SoD2), CTV strain T36
expressing Spinach Defensin Protein 2-1 (SoD2-1), and CTV strain T36
expressing Spinach Defensin Protein 2* (SoD2*) (collectively called
``CTV-SoD2 variants'') 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 in the document, ``Science
review of the human health and product characterization data presented
for the three active ingredients Citrus tristeza virus (CTV) strain T36
expressing Spinach Defensin Proteins (SoD) 2, 2-1 and 2*, and End Use
Product Citrus budwood infected with CTV-SoD2, CTV-SoD2-1 and CTV-
SoD2*'' (Human Health Risk Assessment). This document, as well as other
relevant information, is available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>,
docket ID number EPA-HQ-OPP-2025-0176.
CTV strain T36 was genetically engineered to create three separate
strains expressing spinach defensin genes SoD2, SoD2-1, or SoD2* to
help citrus trees resist citrus greening disease. Spinach defensin
proteins are derived from a food plant (spinach). The spinach defensin
proteins are thought to cause the formation of pores on the outer
membrane of the disease-causing bacterium, thus compromising the
integrity of the membrane and ultimately killing the bacterium. CTV
strain T36, the vector for expression of these defensin proteins, is a
single stranded positive sense RNA virus which is commonly found in
citrus trees globally. Genetically engineered CTV T36 strains carrying
the genes coding for SoD2, SoD2-1, or SoD2* are introduced into the
phloem of citrus trees via bark grafting where the viruses express
these proteins to control citrus greening.
There is a long history of safe exposure to both CTV and spinach
defensins through the consumption of citrus and spinach, respectively.
Given this exposure to both CTV and spinach defensins, there is no
expectation that genetically engineered CTV strain T36 expressing the
three CTV-SoD2 variants are toxic or allergenic to mammals through the
dietary route of exposure. In an acute oral toxicity study conducted
with a single dose of 5000 mg/kg of microbial-produced SoD2 protein, no
evidence of toxic or adverse effects was observed. The estimated acute
lethal dose, LD<INF>50</INF>, was determined to be greater than 5000
mg/kg in female mice (EPA Toxicity Category IV). Due to high amino acid
sequence identity, the other two CTV-SoD2 variants (SoD2-1 and SoD*)
are likely to show a similar toxicity profile. The potential for all
three CTV-SoD2 variants to be allergens is minimal because of
experimentally demonstrated rapid digestion of SoD2 in simulated
intestinal fluid and no indication of cross-reactivity of any of the
three CTV-SoD2 variants to known allergens in in silico studies using
the internationally recognized Codex Alimentarius guidelines.
Oral exposure to the CTV-SoD2 variants through drinking water is
considered unlikely. CTV can only propagate in plant phloem cells and
will be rapidly deactivated by environmental conditions outside of a
plant or insect vector. CTV-SoD2 variants are proteins expressed in
plants. As such, they are susceptible to degradation by environmental
conditions and microbial activity. In the unlikely event that CTV-SoD2
variants do enter drinking water, exposure to these proteins would not
be expected to result in a human health risk based on the same
considerations articulated for food exposure.
Non-occupational and residential exposure is considered to be
negligible. CTV can only propagate in plants, where CTV-SoD2 variants
would be expressed. As such, CTV-SoD2 variants are contained within the
plant cells.
Section 408(b)(2)(C) of FFDCA 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. Here, EPA has determined
that there are no such effects due to the lack of toxicity and
allergenicity of CTV strain T36 expressing SoD2, SoD2-1, and SoD2*
proteins. 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 CTV-SoD2, CTV-SoD2-1, and
CTV-SoD2* proteins since the Agency is establishing an exemption from
the requirement of a tolerance without any numerical limitation.
C. Conclusion
Based upon its evaluation in the Human Health Risk Assessment, EPA
concludes that use of CTV strain T36 expressing SoD2, SoD2-1, and SoD2*
proteins will not result in unreasonable adverse health effects to
humans and 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 active ingredients. Therefore, an
exemption from the requirement of a tolerance is established for
residues of CTV strain T36 expressing SoD2, SoD2-1, and SoD2* in or on
citrus when used according to the label and good agricultural
practices.
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 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
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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 (See Unit IV.A.), and because
EPA does not believe the environmental health or safety risks addressed
by this action present a disproportionate risk to children.
However, EPA's 2021 Policy on Children's Health applies to this
action. This rule finalizes an exemption from the requirement of a
tolerance under the FFDCA, which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
.'' (FFDCA 408(b)(2)(C)). The Agency's consideration is documented in
Unit III.A.
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 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 31, 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 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. Revise Sec. 180.1337 to read as follows:
Sec. 180.1337 Citrus tristeza virus (CTV) strain T36 expressing
Spinach Defensin Proteins SoD2, SoD2-1, and SoD2*; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Citrus tristeza virus (CTV) strain T36 expressing Spinach
Defensin Proteins SoD2, SoD2-1, and SoD2* in or on the commodities
listed in fruit, citrus group 10-10 when used in accordance with label
directions and good agricultural practices.
[FR Doc. 2026-06686 Filed 4-6-26; 8:45 am]
BILLING CODE 6560-50-P
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