Biotech Policy Takes Shape: Rural Task Force Encourages Innovation and Regulatory Coordination

On January 8, 2018, the US Secretary of Agriculture, on behalf of the Interagency Task Force on Agriculture and Rural Prosperity, issued its long-awaited report to the White House recommending over 100 actions to help improve life in rural America. A key part of the Task Force’s findings highlighted the importance of technological innovation and recommended that the US develop a streamlined, science-based regulatory policy for biotechnology, speed the safe commercialization of novel biotechnology products, and increase public acceptance of the same.     
 
The Task Force was created last spring by executive order and its purpose was “to identify legislative, regulatory, and policy changes to promote agriculture, economic development, job growth, infrastructure improvements, technological innovation, energy security, and quality of life in rural America.” The Task Force prepared its report through engagement with stakeholders, consultations with state, local, and tribal governments, and various federal agencies. 
 
The Task Force identified five key indicators of rural prosperity: 1) e-connectivity for rural America; 2) improving quality of life; 3) supporting a rural workforce; 4) harnessing technological innovation; and 5) economic development. Within each indicator, the Task Force provides objectives and recommended actions.
 
Importantly, the report acknowledges that, in view of population growth and increased food demand, the US will need to harness innovation and increase output across American farmlands. The report notes recent advances in technology, including precision agriculture technologies (e.g., GPS guided machinery, embedded sensor networks, unmanned aircraft systems) and biotechnology (e.g., genome editing and genomic selection). The report notes that, “[d]espite American leadership in technological innovation in agriculture, federal regulations are currently limiting both precision agriculture and biotechnology applications.” Among the Task Force’s objectives and recommendations were:

• Development of a Streamlined, Science-based Regulatory Policy for Biotechnology. The Task Force noted that “better coordination” was needed between USDA, EPA and FDA regulations “on genetic modification of crops and livestock … to reduce barriers to commercialization” and recommended that the Administration (a) coordinate federal regulation of biotechnology products by reaffirming strong support for the Coordinated Framework for the Regulation of Biotechnology and subsequent coordination efforts; (b) continue the work of the Biotechnology Working Group, created during the Obama Administration, to facilitate cooperation across relevant government agencies and improve science-based regulatory approaches; and (c) expedite commercialization of biotechnology products by creating a forum led by OSTP that connects regulators with the funding and R&D agencies to increase awareness and speed the safe commercialization of novel biotechnology products.
   
• Increased Public Acceptance of Biotech Products. The Task Force recommended that the State Department, USDA, and other relevant agencies develop a communications strategy to increase acceptance of biotech products and open and maintain markets for US farmers abroad. They also recommend that the US Trade Representative initiate interagency deliberations to identify an international strategy that removes unjustified trade barriers and expands markets for American products.

Analysis

The Task Force report represents the Administration’s clearest statement to date regarding its policy on biotechnology. Its recommendations in some respects pick up where the previous Administration, which had established the Biotechnology Working Group to encourage interagency coordination and modernization of the regulatory process, left off. But the Administration has also signaled a willingness to revisit at least one previous proposal.

In November, USDA withdrew its January 19, 2017 proposed revision to its Part 340 regulations governing genetically engineered plants. FDA’s draft guidance clarifying its regulatory approach as to animal products of biotechnology, also issued on January 19 last year, remains in place for the time being. While the Task Force report does not provide insight into what specific regulatory changes (if any) may be on the horizon, it signals that issues that impact agricultural innovation are on the radar. 
 
Arent Fox will continue to actively monitor these and other developments related to the regulation of current and future biotechnology products. If you would like more information on this or related matters, please contact Karen Carr, Stanley Abramson, Alexander Spiegler, or the Arent Fox attorney who regularly handles your matters.