[Federal Register Volume 91, Number 94 (Friday, May 15, 2026)]
[Proposed Rules]
[Pages 27868-27869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-09833]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 91, No. 94 / Friday, May 15, 2026 / Proposed
Rules
[[Page 27868]]
DEPARTMENT OF AGRICULTURE
Office of the Secretary
7 CFR Parts 330 and 340
[Docket No: USDA-2026-0133]
Request for Information on Modified Organisms Subject to the
Plant Protection Act
AGENCY: Office of the Secretary, U.S. Department of Agriculture.
ACTION: Request for information.
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SUMMARY: The U.S. Department of Agriculture (USDA) proffers this
Request for Information (RFI) to solicit the public's input on
regulatory considerations related to the review of modified organisms
subject to the Plant Protection Act. The information provided will help
identify factors for potential risk-based deregulation and could inform
future rulemaking; input might also offer non-regulatory solutions.
DATES: We will consider all comments that we receive on or before June
15, 2026.
ADDRESSES: USDA invites public comments on this RFI and encourages
stakeholders, including farmers, industry representatives, and state
and local governments, to provide input. You may submit comments,
identified by docket number USDA-2026-0133, in the Federal eRulemaking
Portal: http://www.regulations.gov. Follow the online instructions for
submitting comments. All comments will be posted without change and
will be publicly available on www.regulations.gov. No proprietary
information, copyrighted information, or personally identifiable
information should be submitted in response to this RFI.
FOR FURTHER INFORMATION CONTACT: Michael Poe, Office of the General
Counsel, USDA, 1400 Independence Avenue SW, Washington, DC 20250-1400,
(202) 769-8247.
SUPPLEMENTARY INFORMATION:
Background
Coordinated Framework
Along with the Environmental Protection Agency (EPA) and the Food
and Drug Administration (FDA), the United States Department of
Agriculture's (USDA's) Animal and Plant Health Inspection Service
(APHIS) and the Food Safety and Inspection Service (FSIS) traditionally
exercise oversight of certain organisms modified or developed using
genetic engineering and the foods derived from them. In 1986, the
Office of Science and Technology Policy (OSTP) published the
Coordinated Framework for the Regulation of Biotechnology (Coordinated
Framework). The Coordinated Framework explains the regulatory roles for
EPA, FDA, and the USDA, i.e., APHIS and FSIS, and how existing Federal
statutes protected public health and environmental safety while the
Coordinated Framework's approach nonetheless ensured regulatory
flexibility to foster innovation. The Coordinated Framework was
subsequently updated in 1992 (see 57 FR 6753) and 2017 (see https://www.epa.gov/sites/default/files/2017-01/documents/2017_coordinated_framework_update.pdf) to consider advances that had
occurred in the field of biotechnology. In 2023, USDA, EPA, and FDA
published a document providing ``plain language information'' on the
Coordinated Framework (see https://usbiotechnologyregulation.mrp.usda.gov/sites/default/files/coordinated-framework-plain-language.pdf).
USDA Biotechnology Regulations
Under the Plant Protection Act of 2000, as amended (7 U.S.C. 7701-
7772, 7781-7786, referred to below as the PPA or the Act), the
Secretary of Agriculture has authority to carry out operations or
measures to detect, control, eradicate, suppress, prevent, or retard
the spread of plant pests. Section 411(a) of the Act (7 U.S.C. 7711(a))
provides that ``no person shall import, enter, export, or move in
interstate commerce any plant pest, unless the importation, entry,
exportation, or movement is authorized under general or specific permit
and in accordance with such regulations as the Secretary may issue to
prevent the introduction of plant pests into the United States or the
dissemination of plant pests within the United States.''
In addition, section 412(a) of the Act (7 U.S.C. 7712(a)) provides
that ``[t]he Secretary may prohibit or restrict the importation, entry,
exportation, or movement in interstate commerce of . . . any biological
control organism . . . if the Secretary determines that the prohibition
or restriction is necessary to prevent the introduction into the United
States or the dissemination of a plant pest or noxious weed within the
United States.''
The regulations at 7 CFR part 340 have historically governed the
introduction (importation, interstate movement, or release into the
environment) of certain genetically engineered (GE) organisms. APHIS
first issued these regulations in 1987 under the authority of the
Federal Plant Pest Act of 1957 and the Plant Quarantine Act of 1912;
these two acts were later subsumed into the PPA in 2000 along with
other provisions. Since 1987 and prior to 2020, APHIS amended the
regulations six times, in 1988, 1990, 1993, 1994, 1997, and 2005. These
various amendments instituted several exemptions, among other reforms.
The amendments included exempting certain microorganisms and
Arabidopsis from the requirement for permits, instituting a
notification process and petition procedure, and specifying that plants
engineered to produce industrial compounds are not eligible for the
notification process. On May 18, 2020, APHIS issued a final rule that
marked the first comprehensive revision of the regulations since they
were established in 1987, revising 7 CFR part 340 in its entirety (85
FR 29790-29838, Docket No. APHIS-2018-0034, referred to below as the
SECURE rule). The rule updated APHIS's regulatory framework and focused
regulatory efforts on the properties of the GE organism itself rather
than on the method used to produce it. Different parts of the SECURE
rule became effective on different dates; the final rule's latest
effective date was October 1, 2021. On December 2, 2024, the United
States District Court for the Northern District of California
subsequently issued an order prospectively vacating these regulations;
the Court held that APHIS had violated the Administrative Procedure Act
in issuing the May 2020 final rule. National Family Farm Coalition v.
Vilsack, 758 F.Supp.3d 1060 (N.D. Cal. 2024). The court order
[[Page 27869]]
had the legal effect of restoring the pre-May 2020 regulations. On June
16, 2025, APHIS issued a final rule to make technical conforming
amendments to the Code of Federal Regulations to reflect the court's
vacatur.
7 CFR part 330
The regulations in part 330 govern the movement of plant pests,
biological control organisms, and associated articles, such as soil. 7
CFR part 330 aims to prevent the dissemination of plant pests into the
United States, or interstate, by regulating the importation and
movement in interstate commerce of plant pests, biological control
organisms, soil, and associated articles. In 2020, when APHIS revised
the regulations in part 340, it also revised Sec. 330.200 to indicate
that genetically engineered plant pests and biological control
organisms were exempt from regulation under 7 CFR Part 330 and were
regulated under 7 CFR Part 340. However, the court's vacatur in
December 2024, also vacated these revisions.
7 CFR part 340
Under the current regulations, APHIS oversees the importation,
interstate movement, and environmental release of certain GE organisms.
A GE organism is considered a regulated article if the donor organism,
recipient organism, vector, or vector agent is a plant pest or if the
Administrator has reason to believe the GE organism is a plant pest.
Persons that wish to move or release a regulated article must obtain
authorization through a permit or notification. Upon issuance of a
permit, APHIS specifies conditions that prevent the organism's
dissemination and establishment in the environment. A notification, on
the other hand, is a streamlined alternative to a permit for GE
organisms that fall within certain criteria and are subject to pre-
defined performance standards. In addition to issuing permits and
acknowledging notifications, APHIS responds to petitions that request
nonregulated status under these regulations. Notably, the burden rests
with the developer of a GE organism to petition the agency and show
that its GE organism does not pose a plant pest risk. Such a petition
for nonregulated status, if successful, allows for movement and
environmental release of a GE organism without the regulatory
requirements of notifications or permits.
Executive Order 13874
Executive Order 13874, ``Executive Order on Modernizing the
Regulatory Framework for Agricultural Biotechnology Products'' (June
11, 2019), directs the Federal Government to adopt regulatory
approaches for the products of agricultural biotechnology that are
proportionate to the risks such products pose, and that avoid arbitrary
or unjustifiable distinctions across like products developed through
different technologies. Among other things, Executive Order 13874
states that regulatory decisions should be science- and evidence-based,
taking economic factors into account as appropriate and consistent with
applicable law; that regulatory reviews should be conducted in a timely
and efficient manner; and that biotechnology regulations should be
transparent, predictable, and consistent.
APHIS's decades of experience in evaluating GE plants and
microorganisms for plant pest risk have not revealed a materially
different or distinct set of risks associated with GE plants and
microorganisms when compared to conventional plants and microorganisms.
Further, APHIS's regulations do not take clear notice of substantial
advances in biotechnology since the late 1980s. APHIS, therefore,
wishes to explore alternative frameworks for regulation of GE organisms
under the plant pest provisions of the PPA, to ensure that regulation
and oversight are proportionate to risk, that biotechnology developers
in the United States have a predictable regulatory pathway to
commercialization and, importantly, to ensure APHIS operates within its
statutory authority.
Based on this background information, we solicit public comments
regarding the following questions:
1. Are there material differences in plant pest risk between
conventional and genetically engineered organisms (plants,
microorganisms, or insects)? What is the basis, e.g., science-based
studies, if such a difference exists? If not, should APHIS continue to
distinguish between conventional and genetically engineered organisms
in its Plant Protection Act regulations?
2. Describe your experiences of regulation under the SECURE rule.
Were there areas that could have been improved? Were there obstacles to
performing field trials? What about obstacles advancing from field
trials to commercialization? What were the costs incurred complying
with and/or navigating the regulatory requirements of the SECURE rule?
What areas of the SECURE rule worked well?
3. Describe your experiences of regulation under the current 7 CFR
part 340. Are there areas that could be improved? Are there obstacles
to performing field trials? What about obstacles advancing from field
trials to commercialization? What are the costs incurred complying with
and/or navigating the regulatory requirements of 7 CFR part 340?
4. Could APHIS effectively address plant pest risks of modified
organisms by regulating them under 7 CFR part 330 instead of 7 CFR part
340? What should APHIS consider when determining whether 7 CFR part 330
could replace regulation of modified organisms under 7 CFR part 340?
For example, what might be the trade implications of a new regulatory
framework for modified organisms under the Plant Protection Act?
5. What would the benefits and challenges of regulating modified
organisms under 7 CFR part 330? What changes, if any, would need to be
made to 7 CFR part 330 for effective regulation?
6. Describe key elements of a regulatory framework, including
oversight of field trials, that would enable a scientifically sound
assessment of a modified organism's plant pest risk.
7. Did the SECURE rule--and does the current 7 CFR part 340--impose
disproportionate burdens on smaller entities developing regulated
plants or microorganisms?
8. Are there any other specific issues or topics APHIS should
consider in developing a regulatory framework for assessing the plant
pest risk of modified organisms, or possible pathways to
commercialization for modified organisms?
We welcome all comments on the above questions.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Andrew Perry,
Office of the General Counsel.
[FR Doc. 2026-09833 Filed 5-14-26; 8:45 am]
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