Letter to The Honorable Tom Vilsack, Secretary, U.S. Department of Agriculture - Warning USDA of Uncertainty, Potential Trade Disruptions in Proposed Biotech Revisions


Dear Secretary Vilsack,

We write to you regarding the Animal and Plant Health Inspection Service's (APHIS) Notice of Intent (NOI) to revise pre-market biotechnology regulations, which was published in the Federal Register on February 5, 2016.

As proponents of agricultural innovation, we feel strongly that government policies and regulations should consistently promote scientific advancement in food and agricultural production. Science is helping, and will continue to help, farmers and other food producers feed a rapidly growing global population in the face of increasing weather, pest, disease, and environmental challenges.

We appreciate the U.S. Department of Agriculture's historic commitment to scientific discovery and risk-based regulation for products of biotechnology. This commitment has enabled the development and widespread commercial use of many beneficial biotech crops. For innovation like this to continue, APHIS must proceed cautiously and deliberately with any potential re-write of the current biotechnology regulatory structure. It is also essential that APHIS works closely with stakeholders, other biotechnology regulators, and additional relevant parties, such as our trade representatives, to ensure that any revised rules avoid unintended consequences.

Based on our reading of the NOI and feedback from key stakeholders, we recognize items of both commendation and concern with what has been proposed. We are encouraged that APHIS is seeking to use its existing regulatory authority to exempt classes of biotechnology products the agency knows do not present a risk to agriculture, the environment, or consumers. However, we are concerned that APHIS's proposals have created tremendous uncertainty as to what breeding processes and which categories of products will receive pre-market regulatory scrutiny, and to what degree. In addition, we are concerned that a lack of dialogue between our government and our major trading partners could lead to trade disruptions in significant export markets.

This kind of regulatory ambiguity has the potential to stifle the commercialization of new plant breeding innovation that is particularly valuable to specialty crop producers. Congress has invested significant resources in researching pest and disease challenges within the specialty crop sector. Because many of the most serious pests and diseases confronting specialty crops can be mitigated through innovative plant breeding methods, it is incumbent upon APHIS to focus the scope of potential regulatory changes on areas where there is a clear and justified risk. It would be irresponsible to sweep whole classes of plant breeding methods into a pre-market regulatory structure without scientific and risk-based justification, particularly any methods that have been safely utilized for decades. Doing so would not just hinder innovation in specialty crop production, it would likely prevent scientific breakthroughs that will improve the quality of life and health outcomes for billions of people around the world.

We appreciate your attention to our views and look forward to staying in close contact with the Department as APHIS collects public comments on the NOI and makes decisions related to this sweeping regulatory revision.