NASDA Comments on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology

Comment

Filed By
NASDA CEO Barbara P. Glenn
Filed Date
11/01/2016
Recipient
National Science and Technology Council
Subject
Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology
Docket ID
FDA-2015-N-3403
416.9 KB, PDF

The National Association of State Departments of Agriculture (NASDA) appreciates the opportunity to submit the following comments in response to the Notice of a Request for Comments, published by the National Science and Technology Council, Office of Science and Technology Policy[1] (OSTP).

About NASDA

NASDA represents the Commissioners, Secretaries, and Directors of the state departments of agriculture in all fifty states and four U.S. territories. State departments of agriculture are responsible for a wide range of programs including food safety, combating the spread of disease, and fostering the economic vitality of our rural communities.

NASDA supports agricultural biotechnology and recognizes the important role this technology plays in both meeting growing global demand for food and helping farmers and ranchers address the sustainability of their land and operation for generations to come. Further, NASDA supports the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework)[2], established as a formal policy by the Executive Office of the President, Office of Science and Technology Policy (OSTP) in 1986, and NASDA supports innovative breeding methods, including biotechnology, which hold enormous promise for improving the productivity and environmental sustainability of food, feed, fiber, and biofuels.

General Comments

NASDA broadly supports our federal agency partners’ willingness to revisit, revise, and improve federal regulations to better reflect modern technologies and to facilitate an informed, efficient, and consistent regulatory framework that enables the agricultural community  to continue to produce our nation’s food, fiber, and fuel in an effective and productive manner.  NASDA further supports OSTP’s efforts to better coordinate and communicate the roles and responsibilities of the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) consistent with the objectives described in the July 2, 2015 Executive Office of the President (EOP) Memorandum[3].

NASDA notes the complexity of the various federal agency roles and responsibilities under the Coordinated Framework, and NASDA supports EOP’s formation of a Biotechnology Working Group, which was established under the auspices of the Emerging Technologies Interagency Policy Coordination (ETIPC) Committee (hereinafter “Committee”) to bring greater efficiencies to the Coordinated Framework.

The Committee has the potential to help address the need for enhanced policy coordination. NASDA recommends the Committee facilitate enhanced communication and coordination among EPA, FDA, and USDA to improve federal agency policy coordination.  NASDA also recommends the Committee solicit greater involvement from the regulated community and the Office of the U.S. Trade Representative during the review and consideration of any future regulatory or policy initiatives prior to any final activities to account for the latest scientific advances and to avoid any potential trade disruptions.    

NASDA recommends the three coordinating agencies be more proactive in articulating and communicating the process and status of their respective regulatory processes, and NASDA further recommends the agencies develop and implement a public-facing communications strategy explaining their scientifically-based regulatory determinations.  NASDA notes the value of USDA’s Biotechnology Regulatory Service’s Annual Stakeholder meeting, and NASDA recommends the Committee adopt a similar annual or bi-annual convening of all three coordinating agencies to support and enhance coordination, communication, and regulatory transparency.

Given the regulatory complexity and the potential implications the proposed alternatives may raise throughout domestic and international markets, NASDA requests the Committee work closely with state regulatory agencies and the agricultural stakeholder community to enhance continued alignment and improve communication between the federal, state, and agricultural stakeholders. 

Conclusion

Whether food is grown conventionally, organically, or is the product of genetic engineering, NASDA members advocate for farmers and ranchers across the full scope of agriculture, and NASDA members strive to develop, foster, and assist market channels where producers can market their commodities irrespective of production methods.

NASDA stands ready to assist our federal partners and our producers to ensure federal agency actions reflect and incorporate the best available science, provide a consistent regulatory framework, facilitate innovation, and enable our producers, growers, and other agricultural stakeholders to continue to produce our nation’s food, fiber, and fuel in a collaborative and productive manner.

Thank you for your consideration, and we appreciate this opportunity for comment. Please contact Dudley Hoskins (dudley@nasda.org) if you have any questions or would like any additional information.

Sincerely,           

Barbara P. Glenn, Ph.D.

Chief Executive Officer

NASDA

[1] 81 FR 65414 September 22, 2016.

[2] OSTP.  1986. Coordinated Framework for Regulation of Biotechnology.  51 Fed. Reg. 23302, 23304

[3] Executive Office of the President. Modernizing the Regulatory System for Biotechnology Products. July 2, 2015. https://www.whitehouse.gov/sites/default/files/microsites/ostp/modernizing_the_reg_system_for_biotech_products_memo_final.pdf