WASHINGTON, D.C. — The American Farm Bureau Federation (AFBF) and more than 100 other national farm groups are requesting the USDA Animal and Plant Health Inspection Service (APHIS) make major changes to proposed revisions to its biotechnology regulations, to “ensure the new rules encourage innovation.”

 

“We are supportive of the USDA’s efforts to modernize its regulations, ensuring they are up-to-date with the best-available science and utilize the more than 30 years of experience the USDA has in reviewing the safety of these crops,” the groups said in the June 19 letter to USDA Secretary Sonny Perdue.

“We are concerned that these flaws will have a significant negative impact on innovation, particularly for small companies and universities hoping to develop agricultural products for specific regional or environmental needs, or to develop minor use crops that could be important, domestically and internationally.”

Among the 102 groups urging Perdue to overhaul the USDA’s proposed biotechnology regulations are the American Soybean Assoc. (ASA), Assoc. of Public and Land-grant Universities, National Corn Growers Assoc., Illinois Farm Bureau, Indiana Farm Bureau, Indiana Seed Trade Assoc., Iowa Farm Bureau Federation, Kentucky Farm Bureau Federation, Michigan Farm Bureau and Ohio Farm Bureau Federation.

Despite what the groups said are positive aspects of the USDA’s proposed revisions, they added “regrettably, we believe that the regulatory system proposed by the USDA has significant shortcomings that could make it harder for the USDA to meet its goals.”

Of these shortcomings cited, the groups said researchers and developers would be unable to learn “the regulatory status of new genetically engineered (GE) organisms without undergoing complex and lengthy risk assessments, providing little transparency and clarity about which products will actually be subject to regulation, and risking arbitrariness.”

Another was “risk assessments would be conducted for plant products, merely based upon the technology used in their production, regardless of the actual risk posed by the product,” which the groups stated “runs counter to the USDA’s 30-plus years of experience regulating products of biotechnology.”

Moreover, “the proposed assessment process is unlikely to have the throughput capacity to accommodate the scale of U.S. research and development, potentially leading many products to be trapped in regulatory limbo while their regulatory status is being assessed.”

In addition, the groups said “the significant departure from the current regulatory system may have unintended consequences for other regulatory agencies and domestic and international markets, and lead to significant new litigation risks.”

Ron Moore, president of the ASA, said the proposed rule changes the structure of how biotechnology is regulated by shifting to an upfront risk assessment system.

“While we appreciate the APHIS’ development of an ‘evidence-based, standardized approach to assessing risk,’ this approach shifts the burden to the earliest stages of research and development of new products and will stifle research and innovation,” he explained. Moore said the proposal also does not recognize the enormous undertaking and staff hours that would be required for the USDA to review the thousands of varieties in the research stage, most of which may not be pursued or brought to market.

“We are greatly concerned that many much-needed products will be bottlenecked in a lengthy and timeconsuming process, awaiting the assessment of their regulatory status. The USDA should instead focus on varieties intended for the marketplace.”

Andrew Walmsley, AFBF Congressional relations director, said the biggest concern for U.S. farmers and ranchers is “we obviously want to have confidence in our regulatory system that’s based on science, but also fosters an environment of innovation.

“And if the USDA doesn’t get this right, the impact would be huge both for competitiveness for U.S. farmers and global markets, while also maybe not unleashing the amount of innovation that we need particularly for our smaller seed companies and landgrant universities,” he added.

“Obviously, with a fun issue like biotechnology, there’s opinions on all sides. But, we look forward to working here in Washington with the USDA to help them go through those comments and raise any additional concerns that we might have before they go any further with the final rule.”