The USDA has 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 originally known as the SECURE Rule.
Then a few weeks 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.
What does this mean for plant scientists working on editing and engineering?
- Events exempted under SECURE before December 2, 2025, remain exempted
- 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
- 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 commercialize
- Permits (or notifications for some crops) are also needed to ship events across state lines or contain 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., (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. It is always prudent to ensure that your event is not covered by using the Am I Regulated process– see https://www.aphis.usda.gov/biotechnology/am-i-regulated
Submitted by
Wayne Parrott
Chair, Public Policy Committee
