WASHINGTON, Jan. 18, 2017 - As he leaves office, President Obama’s administration is releasing a series of proposals to update and streamline the regulation of genetically engineered crops and animals.
USDA’s Animal and Plant Health Inspection Service on Wednesday issued a proposed rule that would shift the agency’s regulatory process to focus on new crop traits deemed to pose the most risk. Biotech developers would no longer need to get permits to test many new crops.
The department says the streamlined process would make it easier for smaller companies to raise capital and would encourage scientists to conduct research on minor crops that have traditionally received little attention from the big biotech companies.
The new process would “ensure a high level of plant health protection based on the best available science; improve regulatory processes so that they are more transparent, efficient, and predictable for stakeholders and the public; and provide regulatory relief that will stimulate innovation and competitiveness,” the agency said.
Meanwhile, the Food and Drug Administration, which regulates the safety of biotech foods, announced that it will be taking public comment on how the agency should regulate foods developed through gene editing. FDA also released draft guidance for companies interested in genetically engineering animals.
Both the USDA’s proposed rule and the FDA announcements are part of a government-wide review of biotech policy that the FDA announced in 2015.
USDA’s proposal would represent the first major change to its Part 340 regulations for biotech crops since they were established in 1987 and would incorporate authority provided by Congress in the Plant Protection Act.
For biotech crops that aren’t regulated by FDA or EPA, the cost savings from the proposed changes at USDA could range from $1.5 million to $5.4 million for the development of a given biotech trait, APHIS said. The savings would be lower for crop traits regulated by either EPA or FDA as well as USDA.
USDA’s work on the proposal has some grain companies worried that changes to the U.S. regulatory process could raise concerns among foreign buyers. The department said it was working with those countries and bodies such as U.S.-Canada and Mexico Technical Tri-Lateral and the Organization for Economic Cooperation and Development to explain the changes.
Under the proposal, APHIS would move away from its “regulate first-analyze later” system for regulating testing and commercialization of new biotech crops. In the new system, the agency would first assess whether a new crop trait could become a plant pest or noxious weed. If it doesn’t pose that risk, APHIS would no longer require the developer to get a permit to grow the plants outdoors.
“One of the major departures from our current regulatory approach is that we would no longer regulate strictly on the basis of whether a GE organism was created using genetic material from a plant pest,” APHIS said in a Q&A. “Our experience has shown that the use of genetic material from plant pests has not resulted in the creation of plant pest risks in recipient organisms. We would only regulate if the GE organism itself posed a plant pest or noxious weed risk.”
Under the proposed rule, some genetic medications would remain exempt from regulation, including those developed through deleting genes or making changes that could be done through chemical means or radiation, a process known as mutagenesis that is allowed in organic breeding.
APHIS would continue to regulate plants that have crop and trait combinations that the agency hasn’t previously evaluated for plant pest or noxious weed risks.
Comments on the proposed rule will be accepted through May 19. APHIS also said it plans to release for public comment a draft environmental impact statement.