USDA Finalizes New Genetically Engineered Plant Rules

On May 14, the United States Department of Agriculture (USDA) finalized the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule under the Plant Protection Act. The SECURE rule expands the exemptions for what kinds of genetically engineered plants containing plant pests can be released on the market without the extensive oversight of the Act due to said plants failing to “plausibly pose an increased plant risk.”

The rule represents the first major alteration of plant biotechnology rules by the USDA since 1987 when the initial regulations were issued by the Animal and Plant Health Inspection Service (APHIS) of the USDA under the Federal Plant Plant Pest Act of 1957 and the Plant Quarantine Act of 1912, the two prior laws that now comprise the Plant Protection Act. According to the text of the final rule, while previous regulation proved successful, modifications were necessary in order to “revise our regulatory approach from ‘regulate first before analyzing risks’ to ‘analyze plant pest and noxious weed risks of GE organisms prior to imposing regulatory restrictions’” in light of new evidence that proves that “genetically engineering a plant with a plant pest…does not result in a GE plant that presents a plant pest risk.”

The SECURE rule exempts from Plant Protection Act oversight any genetically engineered plant that, while engineered using plant pests, (1) maintained a genetic make-up similar to that which could be created by natural cross-breeding or (2) was similar in genetic composition to engineered plants already undergoing review.

Those two categories of exemptions include the following types of genetically engineered plants: (1) “the genetic modification is solely a deletion of any size”; (2) “the genetic modification is a single base pair substitution”; (3) “the genetic modification is solely introducing nucleic acid sequences from within the plant’s natural gene pool or from editing nucleic acid sequences in a plant to correspond to a sequence known to occur in that plant’s natural gene pool”; (4) “the plant is an offspring of a GE plant and does not retain the genetic modification in the GE plant parent”; or (5) the plant “has plant-trait-mechanism of action combinations that are the same as those of modified plants” for which regulatory status reviews under the Act are already being conducted.

The SECURE rule exemptions become effective on a category-by-category basis starting August 12, 2020, and ending on April 5, 2021.