The USDA regulated plants derived from recombinant DNA under 7 CFR Part 340. These rules were triggered by the process of adding recombinant DNA and were disproportionate to the amount of risk involved. In 2020, the USDA introduced much-needed reforms, resulting in a much more scientific and streamlined regulatory system for transgenic plants (not necessarily for edited plants) originally known as the SECURE Rule.
Then a few months ago, on Dec 2, 2024, the US District Court for Northern California invalidated the 2020 revisions to Part 340 regulations. Accordingly, on Dec 19, 2024, USDA-ARS announced that the pre-SECURE Part 340 regulations were back in force. The administration did not appeal the ruling. Hence, the original 7 CFR Part 340 is back in force for the foreseeable future.
What does this mean for plant scientists working on editing and engineering?
- Events exempted under SECURE before December 2, 2025, remain exempted
- The Regulatory Status Review process under SECURE is no longer in place; events will now need to go through the deregulation process in order to be commercialized
- Permits are again needed to ship any modified strain of Agrobacterium across state lines, even if they have been disarmed and contain no binary plasmid
- Permits (or notifications for some crops) are also needed to ship events across state lines or conduct field trials of any plant that
- Contains exogenous DNA added by a plant pathogen (i.e., Agrobacterium)
- Contains exogenous DNA derived from a plant pest or plant pathogen (e.g., 35S promoter,nos terminator)
It follows that any event that does not contain exogenous DNA, or that contains exogenous DNA that was not added by a plant pest (e.g., by using protoplast transfection or biolistics) and that was not derived from a plant pathogen is not covered by part 340. If in doubt, one can verify that an event is not covered by using the Am I Regulated process– see https://www.aphis.usda.gov/biotechnology/am-i-regulated.
It also follows that any edited plant that does not contain exogenous DNA (e.g., because the transgenes were segregated away or editing was done by delivering CRISPR/Cas rather than the DNA for them) is not covered by part 340. Developers are allowed to self-determine that they are not regulated, but those needing assurance can also resort to the Am I Regulated process.
Be aware that while an event may be exempted from USDA Part 340 regulations, they may still be covered by FDA regulations (if a food or feed) and by EPA regulations (if the modification provides disease or pest resistance, and possibly if it alters hormones in the plant). All plants are always subject to all quarantine regulations that may apply.
Submitted by
Wayne Parrott
Chair, Public Policy Committee
