USDA Clarifies Gene Editing Oversight

As methods and applications for biotechnology in agriculture continue to advance at a rapid pace, regulators work to maintain a balance between safety and potentially rapid progress in food production. Recent clarification from U.S. Secretary of Agriculture Sonny Perdue on oversight of genomic editing intends to facilitate innovation while continuing to monitor the technology for safety concerns.

Genomic editing techniques, such as CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats and CRISPR-associated protein 9), have recently emerged as promising tools for quickly introducing desirable traits for use in plant and animal breeding. Genomic editing differs from genetic engineering in that scientists delete, insert or substitute pieces of DNA within a species. Genetic engineering, in contrast, modifies an organism by adding genetic material from a different organism, such as Bt corn, which incorporates a gene from Bacillus thuringiensis, a soil bacterium that produces a protein toxic to Lepidoptera larvae such as corn borers.

USDA notes that, under its biotechnology regulations, it does not regulate or plan to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests. Genomic editing, the agency notes, can introduce traits and create new plant varieties that are indistinguishable from those developed through traditional breeding methods. These biotechnology tools can, however, greatly increase speed and precision compared with conventional plant breeding, potentially saving years or decades for introducing valuable traits.

According to the clarification, USDA does not intent to regulate plant varieties with the following changes:

• Deletions—the change to the plant is solely a genetic deletion of any size.
• Single base pair substitutions—the change to the plant is a single base pair substitution.
• Insertions from compatible plant relatives—the change to the plant solely introduces nucleic acid sequences from a compatible relative that could otherwise cross with the recipient organism and produce viable progeny through traditional breeding.
• Complete Null Segregants—off-spring of a genetically engineered plant that does not retain the change of its parent.

“With this approach, USDA seeks to allow innovation when there is no risk present,” says Secretary Perdue. “At the same time, I want to be clear to consumers that we will not be stepping away from our regulatory responsibilities. While these crops do not require regulatory oversight, we do have an important role to play in protecting plant health by evaluating products developed using modern biotechnology.”

Read more about regulatory impacts on biotechnology in a recent report from the Council for Agricultural Science and Technology.