Report from the CRISPR-Ag Bio Conference

USDA explains its approach to gene editing regulation

Report from the CRISPR-Ag Bio Conference

On March 28, USDA Secretary Perdue issued a statement clarifying the department’s oversight of plants produced by new gene editing techniques, including CRISPR. With the USDA’s focus on protecting plant health, gene edited plants that do not contain genetic material from ‘plant pests’, such as viral DNA, will not require their standard regulatory process.

At the recent CRISPR-Ag Bio conference in San Diego, California, several representatives from the USDA spoke about the Secretary’s statement and regulatory status of gene edited plants. The speakers emphasized the USDA’s stance to regulate products, not processes. This is not unfamiliar territory – plants that have been exposed to mutation-inducing chemicals or radiation are not subject to the USDA regulatory process because the mutations induced are not derived from plant pests and are comparable to genetic changes that occur naturally in plants.

Gene edited crops that fall into one of the following categories are likewise considered comparable to natural genetic change:

  1. Sequence deletions
  2. Single nucleotide polymorphisms (SNPs)
  3. Sequence introduction from a compatible organism
  4. Complete null segregants

The USDA also emphasized their commitment to providing regulatory certainty to the agricultural community. The department is looking to develop a framework for regulation that adapts to future innovation, includes “off-ramps” for plants that do not require plant health regulation, and ensures that neither the department, nor plant breeders and innovators waste time in repetitive reviews. The USDA is, of course, a government agency that welcomes comments and input from the agricultural community on policy and procedures – during their talks, the speakers emphasized that they seek unique comments and input. Although an adjacent process to plant health regulation, the USDA is in the open comment period through July 3rd for the Bioengineered Food Disclosure Act.

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