USDA announces final rule for regulating biotech products

By Sarah Gonzalez, Director of Communications and Digital Media

The U.S. Department of Agriculture (USDA) announced on May 14 its final rule for regulating plant-based agricultural biotechnology products.

In a press statement, NGFA noted that it supports the use of agricultural biotechnology and plant breeding innovation to provide farmers with improved technology that can contribute to a sustainable, abundant and affordable food and feed supply.

“However, for grain elevators and exporters, as well as farmers and downstream customers they serve, there is a pressing need to provide transparency in the types and uses of gene-editing and other technology being deployed and commercialized in U.S. grain and oilseed production and supplies,” NGFA said. “On that score, NGFA is disappointed that USDA’s final rule allows crop technology developers to make a ‘self-determination’ that their plant technology is exempt from APHIS regulatory oversight without a concurrent obligation to notify the agency so that such information is available to the marketplace and consumers,” NGFA noted.

NGFA noted that APHIS in its final rule makes repeated references to the importance of preserving U.S. agricultural trade and states that it is committed to “continuing to work with international trading partners and exporters to resolve trade concerns.”  But NGFA emphasized that “transparency in the types of crop technology being deployed and commercialized is essential to avoiding future trade disruptions.”

The final version of the rule is scheduled to be published in the May 18^th Federal Register. The new rule’s provisions become effective on key dates over the next 18 months.

USDA solicited comments from the public on the proposed rule in 2019. NGFA and several other grain- and oilseed-based agribusiness associations issued an August 2019 joint statement outlining concerns about the proposed rule’s lack of regulatory oversight for gene-edited crops, the “self-determination” provision granted to crop technology providers, and whether governmental authorities in key U.S. export markets would accept USDA’s approach.

The U.S. Environmental Protection Agency said it planned to issue its proposed rules addressing gene-editing this summer.  Meanwhile, the Food and Drug Administration continues to ponder issuance of updated guidance concerning how gene-edited and other plant breeding innovation techniques will be addressed under the agency’s voluntary consultation process designed to ensure food and feed safety.