The Agriculture Department will unveil today its proposal to update its regulatory framework of biotechnology. The plan is designed to speed up development of GE plants that do not pose a plant pest or weed risk, and to cover plants created through genome-editing techniques, such as CRISPR, if they pose plant pest or noxious-weed risk. At present, GE plants produced without the use of genetic sequences from plant pests — the traditional method of genetic modification — are not subject to federal biotechnology rules.
“We are proposing to implement the noxious weed authority to close this gap,” said USDA’s Animal and Plant Health inspection Service. The agency, which oversees agricultural biotechnology, said there would be a 120-day comment period on the proposal, which appears in the Federal Register today.
“Producers of the so-called ‘new genome-editing techniques’ would be regulated … only if they pose plant pest or noxious weed risk,” said a USDA fact sheet.
“The rule is likely to result in a broader range of GE organisms being required to come in for review but fewer would be subject to regulatory controls by APHIS over movement via permitting,” said the fact sheet. “Whether APHIS determines a GE organism is regulated by APHIS (needs a permit) or not, the organism would still need to comply with any and all applicable FDA and EPA requirements for safe food for humans and animals and pesticide use.”
In a release, USDA said it is “proposing a regulatory program in which it first assesses GE organisms to determine if they pose plant pest or noxious weed risks.” USDA regulation of GE crops is based on statutes to protect seed purity. Under the proposal, if USDA concludes that an organism does not pose a threat, developers could proceed to ship the organism and advance to regulated and controlled outdoor use such as field trials. If there is a risk, USDA would work with companies to devise safe movement of the plant. At present, a USDA permit is required for all GE plants until there is proof they do not pose a risk.
To read the four-page USDA question-and-answer sheet, click here.