USDA’s SECURE Rule to Regulate Agricultural Biotechnology

USDA’s SECURE Rule to Regulate Agricultural Biotechnology

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Updated August 4, 2023
USDA’s SECURE Rule to Regulate Agricultural Biotechnology
In May 2020, citing 30 years of evidence, the U.S.
separately—irrespective of its similarity to GE varieties
Department of Agriculture (USDA) published a final rule to
approved in the past. Regulated articles required either
revise its regulation of certain genetically engineered (GE)
permits for their importation, interstate transportation,
plants and other organisms (85 Federal Register 29790).
environmental release, or the use of a notification process
USDA’s Sustainable, Ecological, Consistent, Uniform,
when the plant was not considered a noxious weed and met
Responsible, Efficient (SECURE) rule revised the
other standards. Developers could go through a separate
regulations at Title 7, Section 340, of the Code of Federal
petition process to request nonregulated status for an
Regulations and further stated that new GE technologies,
organism that met the regulated article definition.
such as genome editing, do not engage with plant pests in
USDA’s SECURE Rule
any way. The rule was fully implemented in October 2021.
Unlike the prior requirements, USDA’s SECURE rule does
The Coordinated Framework
not assess the risk of every new GE variety and provides
The federal government’s 1986 Coordinated Framework
changes to the exemptions, regulatory status review, and
for Regulation of Biotechnology (Coordinated Framework)
permitting steps of the process, based on APHIS’s current
governs how USDA, the U.S. Food and Drug
understanding of plant-pest risk (Figure 1). If exempted,
Administration (FDA), and the U.S. Environmental
developers can request a written confirmation from APHIS
Protection Agency (EPA) apply existing statutes to regulate
that a plant is not subject to the regulations (I). Plants that
biotechnology products.
are not exempt must undergo a regulatory status review (II),
which replaces the prior petition process. The review is
A key principle of the Coordinated Framework is to
followed by a new permitting process (III), which replaces
regulate products according to their characteristics and
the prior notification process.
unique features rather than the processes used to develop
them (e.g., whether or not they were developed with
Figure 1. The SECURE Rule Process
biotechnology). The Coordinated Framework was updated
in 1992 and 2017 to better guide the federal agencies and
summarize the statutes under which they regulate
biotechnology products.
Regulation of Agricultural Biotechnology
Within the broader Coordinated Framework, EPA regulates

plant pesticides, including those developed through genetic
Source: CRS.
engineering. FDA regulates agricultural products for their
Exemptions and Confirmations (§340.1)
safety for human and animal consumption. USDA’s
USDA’s SECURE rule exempts certain categories of
primary engagement with the regulation of biotechnology-
engineered plants (not other organisms) from the
derived products has been through the Animal and Plant
Health Inspection Service’s (APHIS’s
regulations because USDA deems that they could otherwise
) oversight of GE
have been developed through conventional breeding.
plants under the Plant Protection Act (PPA; 7 U.S.C.
APHIS considers that such plants (e.g., certain genome-
§§7701 et seq.). Under the PPA, APHIS regulates the
edited varieties) are “unlikely to pose an increased plant
importation, interstate movement, and environmental
pest risk compared to conventionally bred plants.” USDA’s
release (including field testing) of GE plants and organisms
SECURE rule also exempts plants with a plant-trait-
that may pose a plant-pest risk. Plant-pest risk is the
mechanism of action combination (i.e., a combination of
potential for injury, damage, or disease in any plant or plant
species, GE trait, and how the GE trait was introduced) that
product resulting from introducing or disseminating a plant
APHIS has previously deregulated or determined need not
pest, or the potential to exacerbate a plant pest’s impact.
be regulated. Under the revised rules, developers self-
APHIS’s PPA regulations for GE organisms (7 C.F.R.
determine if their product meets the exempt status and can
§340) define regulated articles (i.e., the organisms subject
request written confirmation from APHIS that a plant is not
to these PPA regulations; most are plants), processes to
subject to the regulations. The exemption and confirmation
determine whether they are regulated, and how APHIS
process took effect in August 2020.
regulates them.
Regulatory Status Review (§340.4)
USDA’s Previous Requirements
The regulatory status review (RSR) process replaces the
Prior to USDA’s SECURE rule, product developers would
prior petition process. Product developers may request a
seek a USDA determination of whether a new organism
permit or an RSR for a new GE plant that APHIS has not
met the definition of a regulated article through the APHIS
previously evaluated and determined to be nonregulated.
Am I Regulated? process. In this process, APHIS assessed
Under the RSR process, APHIS evaluates whether the plant
the plant-pest risk of each new GE plant variety
requires additional oversight based on its characteristics—
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USDA’s SECURE Rule to Regulate Agricultural Biotechnology
its plant-pest risk—rather than the method used to develop
in the biotechnology context, including those to protect
it. If APHIS determines that the plant is not regulated, then
consumers from risk and support businesses and innovation.
later GE varieties using the same plant-trait-mechanism of
Some stakeholders have long called for updates to federal
action combination also would not be regulated. If APHIS
biotechnology regulations in light of scientific advances.
cannot determine that the plant does not pose a plant-pest
Genome editing, which allows scientists to alter the
risk, then it would require a permit. The RSR process took
characteristics of an organism through genetic changes in a
effect for all GE plants in October 2021.
more targeted way than previous biotechnology approaches
Permitting (§340.5)
permitted, was developed decades after the Coordinated
USDA’s SECURE regulations require a permit for the
Framework was designed. Some assert that genome-edited
importation, interstate movement, or environmental release
products should not require the same regulatory scrutiny as
of any GE organisms that may pose a plant-pest risk. These
products developed through less-targeted techniques.
include plants and other organisms that do not meet the
Others have argued that all biotechnology products may
exemption criteria or are determined to pose a plausible
present new risks and should be strictly regulated.
plant-pest risk through the RSR process.
In 2019, the Trump Administration issued Executive Order
Developers may request a permit instead of an RSR, or they
(E.O.) 13874, “Modernizing the Regulatory Framework for
may request both. The RSR and permitting processes
Agricultural Biotechnology Products” (June 2019). The
replace the former rule’s notification process. The changes
order called for USDA, FDA, and EPA to coordinate in
took effect in April 2021.
modernizing the regulatory framework for agricultural
Reactions to the Changes
plants and animals produced through biotechnology. It also
asked the agencies to review existing policies and
Initial stakeholder reaction to USDA’s final SECURE rule
regulations, identify those that could be streamlined in
has been mixed. Some exporter and consumer groups have
accordance with the E.O.’s policy guidance, begin to
criticized the rule, while some producer groups have
implement such changes, and exempt low-risk products
supported it.
from regulation “as appropriate.”
In a May 2020 statement, the National Feed and Grain
In 2022, the Biden Administration issued E.O. 14081,
Association stated that the rule “takes an overly broad
“Advancing Biotechnology and Biomanufacturing
approach that does not deliver adequate transparency and
Innovation for a Sustainable, Safe, and Secure American
could contribute to future trade disruptions.” The Center for
Bioeconomy,” ordering the three agencies to further
Science in the Public Interest stated that “a majority of
improve the clarity and efficiency of regulatory processes
genetically engineered and gene-edited plants now will
for biotechnology products and increase coordination and
escape any oversight,” and “government regulators and the
communication between federal regulatory agencies. FDA
public will have no idea what products will enter the market
encourages developers of all new plant varieties to request
and whether those products appropriately qualified for an
premarket food safety consultations with the agency, which
exemption from oversight.” Among supporters, the
involves a discussion of the safety protocols and regulatory
National Farm Bureau Federation stated that “the revised
issues before the food is distributed in the market
rule will encourage innovation of new plant breeding
techniques while safeguarding our food supply.” The
In response to E.O. 14081, in May 2023, EPA announced
National Corn Growers Association stated that the new rule
changes to its regulations concerning genetically engineered
provides “a modern framework to better address the
plant-incorporated protectants (PIPs). These changes
innovations in and challenges facing modern agriculture.”
exempt certain PIPs from registration and tolerance
requirements while implementing a notification process for
USDA states that the revised process has helped expedite
transparency. EPA intends to consider additional
the approval timing for new plants developed with
exemptions and expand the list of categories not requiring
biotechnology to about 41 days on average from
EPA confirmation as biotechnology progresses. EPA’s rule
submission, with small and medium-sized enterprises being
(88 C.F.R. §§34756 et seq.) went into effect in July 2023.
the main clients. Although self-determination of
Congressional Interest
exemptions provides flexibility in the approval process for
developers, some have argued that it may provide less
Congress may be interested in monitoring how USDA’s
robust oversight of new GE and gene-edited varieties
revised regulatory requirements have affected the
available in the market than the previous process.
development and commercialization of GE and genome-
edited products. Beyond that, Congress may consider
In its five-year Strategic Plan for FY2023-FY2027, APHIS
monitoring how USDA, FDA, and EPA are assessing the
stated that one of its objectives is to ensure the safe
effectiveness of the revised regulations, as underlined by
development of agricultural biotechnology products using a
the self-determination aspect of the exemption status of new
science-based regulatory framework, including efficient
GE and genome-edited products. Further, Congress may
permit review for GE organisms, clear communication of
also oversee how well the three agencies are working
regulations to stakeholders, coordination with other
together to harmonize the regulation of biotechnology
agencies, and harmonization of regulatory oversight for
products moving forward.
biotechnology products.
Context for Regulatory Updates
Eleni G. Bickell, Analyst in Agricultural Policy
USDA issued its SECURE rule amid a broader debate
IF11573
about how the federal government should manage its roles
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USDA’s SECURE Rule to Regulate Agricultural Biotechnology

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https://crsreports.congress.gov | IF11573 · VERSION 4 · UPDATED