“This new Administration has a real opportunity to set a clear and consistent policy direction that promotes continued American bioscience innovation and job growth by focusing regulatory time and attention on actual risk,” says Dana O’Brien, BIO’s Executive Vice President for Food and Agriculture. “We hope the Administration will reflect on BIO’s comments and come to the same conclusion – to support consistent, science-driven, and risk-proportionate regulatory treatment for biotechnology products.”
BIO provided comments on USDA’s proposed revisions to its plant biotechnology regulations (7 CFR Part 340), FDA’s proposed revisions to its animal biotechnology guidance document (Guidance for Industry #187), and FDA’s request for information about plants derived from precision breeding methods, such as genome editing.
USDA
In its comments, BIO applauded USDA’s attempt to provide regulatory relief by matching the level of oversight with actual risk for certain genetically-engineered (GE) plants and for many products of genome editing. USDA’s proposal recognizes that some new plant varieties developed with genome editing are essentially the same as traditionally bred varieties. But for the many GE plants that still would be subject to pre-market oversight under USDA’s proposal, the proposed changes create tremendous uncertainty. USDA’s proposed approach for those products appears to be arbitrary and unnecessarily burdensome. It also may have unintended negative consequences for access by American innovations to domestic and international markets. BIO urges USDA to rethink its proposal and to re-propose a new approach that captures the positive, innovation-creating concepts of its original proposal while taking steps to avoid its risks to innovation and market access for biotechnology products.
FDA
In two sets of comments to FDA, BIO urged the agency to align with the positive aspects of USDA’s proposal to establish consistent, science-based policy for precision plant and animal breeding innovations. As USDA notes, these products are essentially equivalent to varieties that are being or can be developed through traditional breeding. However, rather than being consistent with USDA, FDA’s Center for Veterinary Medicine has proposed to expand the scope of its existing pre-market oversight to include genome edited animals without any adequate risk- or science-based rationale to do so.
“Strong leadership within and between regulatory agencies is required to restore science-based risk management for biotechnology products. Such leadership and rational, predictable policy will drive increased private investment, grow bioscience jobs, and foster global marketplace acceptance for America’s innovations,” says O’Brien.
“We look forward to continuing a dialogue with the Administration and with our colleagues in the food value chain as these important regulatory conversations continue,” he added.
