Jacob Wong
The USDA announced Monday, Nov. 6 that it was pulling back proposed guidelines on the regulatory process for biotechnology products such as genetically engineered crops, with the agency stating in a press release that it planned to “re-engage with stakeholders to determine the most effective, science-based approach for regulating the products of modern biotechnology while protecting plant health.”
Drafted back in January, the rule changes signal an attempt by the USDA to balance the concerns of environmental and consumer safety groups with the growing demands of America’s ever-expanding biotech industry. Secretary Sonny Perdue said in a statement issued by the USDA, “It’s critical that our regulatory requirements foster public confidence and empower American agriculture while also providing industry with an efficient and transparent review process that doesn’t restrict innovation.”
The proposed rule changes would have modified the criteria used by the USDA’s Animal and Plant Health Inspection Service (APHIS) to classify gene-edited products as “genetically engineered” (GE), thereby making them subject to further regulations. At the time, the potential changes represented a major break from the agency’s previous “analyze first/regulate later” approach.
The proposed rule changes signaled a change in focus from the production process to the product itself. In a fact sheet issued by APHIS in January, the agency stated that it “would no longer regulate strictly on the basis of whether a GE organism was created using genetic material from a plant pest,” but instead “would only regulate if the GE organism itself posed a plant pest or noxious weed risk.”
Despite the APHIS’s efforts to appease both research and consumer advocacy groups with the January rule changes, the proposal ultimately failed to garner support from either side. Along with the Monday announcement, the agency submitted a notice in the federal register detailing the broad range of criticism targeted at the proposal. The agency reported that a significant portion of the public comment they received objected to the scope of the rule, as some commenters thought the new criteria for GE designation was too wide and would result in excessive regulations, while others worried that the new rules would “narrow the scope of (the APHIS’s) regulatory authority over GE organisms.”
While the January rule changes modified the USDA’s regulatory standards, they did not necessarily cut down on regulations. In some cases, the proposal might have increased the regulatory burden on biotech developers — since the new system targeted plants posing overt health or environmental risks, enforcing the rules would have required increased risk assessment of gene-edited products to ensure that they didn’t pose such a threat.
An angry coalition of over 100 agricultural and biotech development groups sent the agency a letter in June citing concerns that the new system would cause “many products to be trapped in regulatory limbo while their regulatory status [was] being assessed.” The APHIS acknowledged these concerns in its Monday statement: “Some commenters expressed concern that the proposed risk assessment process could prove lengthy, cumbersome, and confusing, thereby hindering innovation and preventing GE products from getting to market in a timely manner.”
Further updates on the USDA’s Monday announcement can be found on the agency’s website, https://www.aphis.usda.gov/biotechnology/news.