USDA Animal and Plant Health Inspection Service (APHIS) announced on January 23, 2025, that it is reinstating its legacy notification procedure as of February 7, 2025, providing a streamlined alternative to permits for regulated genetically engineered (GE) organisms.
This change comes in response to a December 2, 2024, ruling by the U.S. District Court for the Northern District of California that struck down the 2020 revisions to APHIS’s biotechnology regulations (“the 2020 Rule”), which had created exemptions for specific categories of GE plants that could otherwise have been developed through conventional breeding techniques. Although it was initially unclear whether the recent amendments to the 2020 Rule, which had added two additional exemptions and became effective on November 13, 2024, were included in the vacatur, APHIS recently acknowledged in a January 28, 2025, court filing that the December ruling also nullified the November 2024 amendments to the 2020 Rule.
On January 28, 2025, the Court further ruled that plaintiffs’ remaining two challenges to the Rule (under the Endangered Species Act and the National Environmental Policy Act, respectively, neither of which had been addressed in the initial ruling) are moot in light of the vacatur of the 2020 Rule. With the remaining claims mooted, APHIS could now appeal the case to the 9th circuit to seek reinstatement of the 2020 Rule and its 2024 amendments. As of the publication of this post, APHIS has not publicly announced plans to appeal the ruling.
Overview of the Reinstated APHIS Regulatory Process (7 CFR 340 (2019))
In order to be regulated by the now-reinstated legacy framework, found in 7 CFR §340.1 (2019) (“the Reinstated Rule”), a GE organism must first be considered a “regulated article.” The Reinstated Rule defines a regulated article as a genetically engineered organism in which “the donor organism, recipient organism, or vector or vector agent belongs to any genera or taxa designated in § 340.2 and meets the definition of plant pest,” or that APHIS otherwise believes to be a plant pest. As discussed in the section below, this definition may not apply to many GE plants being produced today.
Under the Reinstated Rule, developers must determine whether their GE plant constitutes a regulated article and is thereby subject to the Reinstated Rule. Developers may request confirmation from APHIS that a GE organism is not subject to the Reinstated Rule via the “Am I Regulated?” (AIR) process. This voluntary process allows developers to seek a determination of nonregulated status, meaning that the regulations under 7 CFR part 340 (2019) would not apply to the organism.
If the organism is regulated, developers must apply to APHIS for a permit or use the notification procedure in order to import the organism, ship the organism interstate, or release the organism into the environment (including growth in an open field).
The notification procedure, which has been reinstated as of February 7, 2025, allow developers to notify APHIS of their intent to move a regulated article that meets specific criteria, rather than undergoing a full permitting review.
CRISPR Gene-Edited Plants May Fall Outside the Scope of APHIS Regulation
Although the 2020 Rule was explicitly designed to exempt many plants produced using modern gene editing and to streamline the regulatory burdens for GE plants overall, in a surprising twist, the Reinstated Rule appears to be largely inapplicable to many edited plants being developed today, such as many plants developed using CRISPR. The Reinstated Rule was developed at a time in which genetic engineering effectively meant transgenic insertion, and often required use of plant pathogens, but modern methods such as CRISPR increasingly allow for precise, targeted modifications to DNA without the need for the stable integration of foreign DNA from plant pests. Although the 2020 Rule crafted an array of exemptions for plants that contained specific types of edits, the Reinstated Rule contained no such exemptions, and generally placed a high regulatory burden on developers of organisms that were subject to its provisions.
Thus, while observers initially expected the vacatur of the 2020 Rule to yield a return to more stringent regulatory oversight, the rapid expansion and adoption of CRISPR and related techniques over the past five years has made the Reinstated Rule paradoxically more permissive than the 2020 Rule to some types of edits.
As discussed above, regulation by APHIS under the reinstated framework centers on whether a GE organism is, or is altered with the use of, a plant pest, as defined by APHIS. A GE organism that is not a plant pest or reasonably likely to be a plant pest and has not been modified to contain foreign DNA is not subject to regulation by APHIS under 7 CFR Part 340.
The definition of “regulated article” may leave a regulatory gap for GE plants modified using techniques that do not permanently introduce plant pest components into the plant’s DNA. This is illustrated by APHIS’ response to certain AIR inquiries from before the 2020 rule, which are publicly available on APHIS’s website.
For example, APHIS’s 2020 response to a Corteva Agriscience inquiry regarding a line of GE corn concluded that the corn line was not a regulated article despite the use of plant pest components in components of the editing process, because the edited corn lines “are not themselves plant pests and no plant pest sequences were integrated into the plant genome of corn.” The corn lines were produced by biolistic introduction of CRISPR-Cas9 components and a repair template to introduce targeted base pair substitutions. Through subsequent reproduction and selection, the final edited corn lines contained the intended base pair substitutions but no unintentionally integrated DNA from the components of the editing process, leading APHIS to conclude that the genome-edited corn lines were not regulated under the Reinstated Rule.
The foregoing example and other published 2020-era AIR letters suggest that many CRISPR‑edited plants, particularly those that do not permanently introduce foreign DNA, may fall outside the scope of APHIS regulation altogether. Thus, the vacatur of APHIS’s 2020 and 2024 rules, which exempted many CRISPR-edited GE plants, may not result in a categorical re‑regulation of all those products. However, developers who believe their GE plant may fall outside the scope of the Reinstated Rule will need to self-determine whether their GE plant meets the definition of a regulated article or submit an AIR inquiry to receive a determination from APHIS. If such plants are indeed nonregulated, they may be imported, shipped interstate, and released outside without a permit from APHIS, though other regulations may still apply.
We are closely monitoring developments in this area and will continue to share updates.