Keeping the Pace!

What says ASTA on the U.S. biotech revision?

Biotechnology Products in the United States are regulated by three federal agencies: U.S. Department of Agriculture (USDA), Environmental Protection Agency and Food and Drug Administration. The original regulatory framework stems from 1986 and is currently under revision. What does the American Seed Trade Association (ASTA) have to say about the work in progress? Our sister publication European Seed spoke with Bernice Slutsky, senior vice president, innovation, of ASTA to find out what the seed sector thinks of the proposed revisions.

European Seed (ES): Why was it necessary to modernize the current regulations?

Bernice Slutsky (BS): It’s been 30 years since the USDA last revised its biotechnology regulations. Clearly there’s been a lot of innovation over the past three decades, especially with the emergence of newer, precise breeding methods like gene editing revolutionizing plant breeding as we know it. To support continued innovation, it’s critical that regulations keep pace with the latest scientific advancements. USDA has gained extensive experience in reviewing genetically engineered plants over the years, and the regulatory revisions should reflect that experience. 

ES: For the seed sector, which are the key issues and challenges you’re facing?

BS: Today, as we face unprecedented global-scale challenges like climate change, emerging pests and diseases and rapid population growth, plant breeding continues to evolve and innovate, to help deliver solutions. However, lack of consistent, science-based policies around products of plant breeding innovation could impede access to these methods and stifle our ability to continue to evolve to meet global challenges. To fully realize the benefits of innovations like gene editing, we need a policy framework that is clear and predictable and offers a rational path to commercialization. 

ASTA has always looked at this not just from a domestic perspective, but through a global lens. Not only do we need the right policies domestically, it’s critical that we work toward consistent, aligned policies at the international level. 

ES: In June 2019, the USDA proactively proposed a rule. What is ASTA’s take on the proposed rule?

BS: We commend USDA for working to update its long-standing regulatory system for genetically engineered organisms to ensure it keeps pace with the latest scientific advancements. Specifically, we’re pleased that the proposal recognizes that some applications of gene editing result in plant varieties that are essentially equivalent to varieties developed through more traditional breeding methods and would thus treat these varieties in the same way from a policy standpoint. While we support the exclusion of these specific categories of products from an additional pre-market review under Part 340, we are offering some recommendations relating to the definitions, structure and language of these exemptions. 

We look forward to working with USDA as this process moves forward to ensure that plant breeders of every size and sector have access to the best and latest tools available to meet the challenges of tomorrow. And we remain committed to continuing the important dialogue with consumers about plant breeding and what it means for our future, as we collectively develop new and innovative solutions to address some of society’s most pressing challenges.