USDA’s new Part 340 and impact on gene edited plantsMay 19, 2020

The USDA published a new version of agricultural biotechnology regulations (7 CFR Part 340, aka “Part 340”) which is the culmination of several years of revision and public review.

In this revised rule, which will begin implementation 90 days from May 18^th, developers now have more definitive guidelines on where plants will be exempt from pre-market review by USDA, along with a new pathway for engaging with regulators for verification of non-regulated status.

There are two categories under the new rule where USDA has explicitly stated that pre-market review is not required. These categories include: 

1. Plants that contains a plant-trait-mechanism of action combination that APHIS has already evaluated under the previous or new regulations, and found to be unlikely to pose a plant pest risk.
2. Plants with certain gene edits or with genetic changes that could have occurred naturally.

 Specifically, a plant containing a single modification type from one of the following three categories is exempt from regulation:

1. A change resulting from cellular repair of a targeted DNA break in the absence of an externally provided repair template; or
2. A targeted single base pair substitution; or
3. Introduction of a gene known to occur in the plant’s gene pool, or a change in a targeted sequence to correspond to a known allele of such a gene or to a known structural variation present in the gene pool.   

Developers may self-determine whether a plant belongs to one of the categories exempt from the pre-market review. However, given potential legal and liability issues resulting from such a self-determination, this is likely to be a path taken by select organizations rather than established companies with clear commercial intent. A developer also has the option to request written confirmation from APHIS that the plant is exempt, which is similar to the current “Am I Regulated” process, with a projected timeline for confirmation within 120 days.

If a plant is not exempt from pre-market review, there are two regulatory pathways are available: 1) USDA would issue a permit for importation, interstate movement, or environmental release; or 2) USDA would conduct a formal “regulatory status review” (RSR) to determine whether the plant should be subject to USDA regulations.  This new RSR process will begin to be implemented in April of 2021 for corn, soybean, cotton, potato, tomato, and alfalfa; the remainder of plant species can use the new process in October of 2021.

As previous USDA-related news was over-generalized to reflect on the overall U.S. regulatory framework for gene edited plants, it is important to note that this USDA rule change does not change oversight of agricultural biotechnology by the FDA or EPA, which, respectively, oversee food safety and the efficacy and safety of any plant-incorporated protectant of edited plants.  The EPA is expected to release draft proposed guidelines for regulation of gene edited plants which may contain a plant-incorporated protectant this summer.

Cassie J. Edgar, Patent Attorney and Chair of the Regulatory Law practice group, advises clients in intellectual property, regulatory law, crisis management, compliance, stewardship, lobbying, and matters with USDA, FDA, EPA, and FTC. For additional information, please visit MVS or contact Cassie directly via email at cassie.edgar@ipmvs.com.