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June 12, 2020
USDA’s SECURE Rule to Regulate Agricultural Biotechnology
On May 18, 2020, the U.S. Department of Agriculture
risk refers to the potential for injury, damage, or disease in
(USDA) published the final rule to revise its regulation of
any plant or plant product resulting from introducing or
certain genetically engineered (GE) plants and other
disseminating a plant pest or potential to exacerbate a plant
organisms (85 Federal Register 29790). USDA’s
pest’s impact. FDA regulates agricultural products for their
Sustainable, Ecological, Consistent, Uniform, Responsible,
safety for human and animal consumption, and EPA
Efficient (SECURE) rule revises the regulations at Title 7,
regulates plant pesticides, including those incorporated
Section 340, of the Code of Federal Regulations. Phased
through genetic engineering. The APHIS regulations (7
implementation begins in June 2020, with full
C.F.R. §340) specify what organisms APHIS regulates
implementation by October 1, 2021.
(most regulated articles are plants), processes to determine
The Coordinated Framework
whether they are regulated, and how APHIS regulates them.
USDA’s SECURE rule is one component of the broader
USDA’s Previous Regulations
federal regulation of biotechnology products (e.g., GE
Prior to USDA’s SECURE rule, product developers could
plants, animals, and other organisms). The federal
seek a USDA determination of whether a new organism
government’s Coordinated Framework for Regulation of
met the definition of regulated article through the APHIS
Biotechnology (the Coordinated Framework, 51 Federal
Am I Regulated? process. A petition process allowed
Register 23302, June 26, 1986) outlines how USDA, the
individuals to request non-regulated status for an organism
U.S. Food and Drug Administration (FDA), and the U.S.
that met the definition. In this process, APHIS assessed the
Environmental Protection Agency (EPA) apply existing
plant-pest risk of each new GE plant variety separately—
statutes to regulate biotechnology products (Figure 1). A
irrespective of its similarity to GE varieties that APHIS had
key principle of U.S. biotechnology policy is to regulate
approved in the past. Regulated articles required either
products according to their characteristics and unique
permits for their importation, interstate transportation, or
features rather than the processes used to develop them.
environmental release or use of a notification process in
Figure 1. Primary Legislative Authorities of Federal
lieu of permits when the plant was not considered a noxious
Biotechnology Regulation
weed and met other standards.
USDA’s New Regulations
USDA states that the final SECURE rule is the first
“significant” revision of the APHIS regulations since their
creation in 1987. Unlike the prior rule, USDA’s SECURE
rule does not assess the risk of every new GE variety. It
applies APHIS’s current understanding of plant-pest risk to
exempt broad categories of new plants from review:
APHIS’ evaluations to date have provided evidence
that genetically engineering a plant with a plant pest
as a vector, vector agent, or donor does not result in
a GE plant that presents a plant pest risk. Further,
genetic
engineering
techniques
have
been
developed that do not employ plant pests … yet may
result in organisms that do pose a plant pest risk.
Major changes relate to exemptions, regulatory status
Source: CRS.
review, and permitting, described in more detail below.
Federal Regulation of Agricultural
Biotechnology
Exemption and Confirmation Process (§340.1)
USDA’s SECURE rule exempts certain categories of
Within the broader Coordinated Framework, USDA and
modified plants (not other organisms) from the regulations
EPA regulate the environmental release, transportation, and
because they could otherwise have been developed through
importation of GE agricultural products, including plants
conventional breeding. The rule identifies exemptions
and other organisms (e.g., insects, mushrooms, microbes).
based on the type of GE modification. APHIS considers
FDA regulates GE material used in food products.
that such plants (e.g., certain genome-edited varieties) are
Within USDA, the Animal and Plant Health Inspection
“unlikely to pose an increased plant pest risk compared to
Service (APHIS) regulates new plants and other organisms
conventionally bred plants.” USDA’s SECURE rule also
according to their plant-pest and noxious weed risk under
exempts plants with a plant-trait-mechanism of action
the Plant Protection Act (7 U.S.C. §7701 et seq.). Plant-pest
combination (i.e., combination of species, GE trait, and
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USDA’s SECURE Rule to Regulate Agricultural Biotechnology
how the GE trait was introduced) that APHIS has
long called for updates to federal biotechnology regulations
previously deregulated or determined need not be regulated.
in light of scientific advances. Genome editing, which
Developers can request a written confirmation from APHIS
allows scientists to alter the characteristics of an organism
that a plant is not subject to the regulations. Exemptions do
through genetic changes in a more targeted way than
not include non-plant organisms. The exemption and
previous biotechnology approaches permitted, was
confirmation process takes effect on August 17, 2020. It
developed decades after the Coordinated Framework was
replaces the prior Am I Regulated? process.
designed. Some have argued that genome-edited products
Regulatory Status Review (§340.4)
should not require the same regulatory scrutiny as products
developed through less-specific techniques. Others have
The regulatory status review (RSR) process replaces the
argued that products of all biotechnology may present new
prior petition process. Product developers may request a
risks and should be strictly regulated.
permit or an RSR for a new GE plant (not other organisms)
that APHIS has not previously evaluated and determined to
The federal government revised the Coordinated
be non-regulated. Under the RSR process, APHIS evaluates
Framework in 1992 and 2017. These updates did not
whether the plant requires additional oversight based on its
involve changes to the underlying legislation and did not
characteristics—its plant-pest risk—rather than the method
change the long-standing federal policy of evaluating risks
used to develop it. If APHIS determines that the plant is not
and regulating products based on their characteristics rather
regulated, then later GE varieties using the same plant-trait-
than the processes used to develop them. The 2017 update
mechanism of action combination would not be regulated.
states:
If APHIS cannot determine that the plant does not pose a
It is the characteristics of the biotechnology
plant-pest risk, then it would require a permit. The RSR
product, the environment into which it will be
process is to be implemented for new GE corn, soybeans,
introduced, and the application of the product that
cotton, potatoes, tomatoes, and alfalfa beginning April 5,
determine its risk (or lack thereof).
2021, and for all GE plants by October 1, 2021.
Following the 2017 update, USDA addressed its position on
Permitting (§340.5)
the regulation of genome-edited plants in a March 28, 2018,
USDA’s SECURE regulations require a permit for the
statement, stating it did not—and did not plan to—“regulate
importation, interstate movement, or environmental release
plants that could otherwise have been developed through
of any GE organism that may pose a plant-pest risk. These
traditional breeding techniques as long as they are not plant
include plants that do not meet the exemption criteria or are
pests or developed using plant pests.”
determined to pose a plausible plant-pest risk through the
RSR process, and other organisms. Developers may request
The following year, the Trump Administration issued
a permit instead of an RSR, or they may request both. The
Executive Order (E.O.) 13874, Modernizing the Regulatory
RSR and permitting processes replace the former rule’s
Framework for Agricultural Biotechnology Products (June
notification process. The changes take effect April 5, 2021.
11, 2019). This E.O. called for USDA, FDA, and EPA to
coordinate in modernizing the regulatory framework for
Stakeholder Reactions
agricultural plants and animals produced through
Initial stakeholder reaction to USDA’s final SECURE rule
biotechnology. It called for the agencies to review existing
has been mixed. Some exporter and consumer groups
policies and regulations, identify those that could be
criticized the new rule, while some producer groups
streamlined in accordance with the E.O.’s policy guidance,
supported it. In a May 14, 2020 statement, the National
begin to implement such changes, and exempt low-risk
Feed and Grain Association stated that the rule “takes an
products from regulation “as appropriate.” The SECURE
overly broad approach that does not deliver adequate
rule meets this obligation for USDA. FDA and EPA have
transparency and could contribute to future trade
not yet revised their agricultural GE product regulations.
disruptions.” On the same date, the Center for Science in
Congressional Interest
the Public Interest stated that “a majority of genetically
engineered and gene edited plants now will escape any
Congress may be interested in how any future changes to
oversight,” and “government regulators and the public will
FDA and EPA regulation of GE plants align with the
have no idea what products will enter the market and
changes introduced through USDA’s SECURE rule. As
whether those products appropriately qualified for an
implementation of USDA’s rule begins and potential
exemption from oversight.”
updates of FDA and EPA regulations are made, Congress
may consider whether the statutes underlying the
Among supporters, the National Farm Bureau Federation
Coordinated Framework continue to provide appropriate
stated that “the revised rule will encourage innovation of
regulatory guidance or whether they require revision.
new plant breeding techniques while safeguarding our food
supply.” The National Corn Growers Association stated that
USDA’s rule could also raise new concerns in international
the new rule provides “a modern framework to better
trade. Some have questioned whether certain U.S. trading
address the innovations in and challenges facing modern
partners would accept the revised regulatory requirements
agriculture.”
as sufficient to meet their own regulations for importing
U.S. GE products. Congress may choose to monitor U.S.
Context for Regulatory Updates
trading partner responses.
USDA issued its SECURE rule in the midst of a broader
debate about how the federal government should manage its
Genevieve K. Croft, Analyst in Agricultural Policy
roles, including those to protect consumers from risk and to
Tadlock Cowan, Analyst in Natural Resources and Rural
support businesses and innovation. Some stakeholders have
Development
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USDA’s SECURE Rule to Regulate Agricultural Biotechnology
IF11573
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