By Kristen Hildreth
Products using biotechnology can be found every day, from the bananas at your local grocer, the ethanol in the gas at the station down the road, jeans from your favorite department store, and the vaccines from your physician’s office.
The Biotechnology Innovation Organization defines it as technology based on biology, that “harnesses cellular and biomolecular processes to develop technologies and products,” playing a major role in our daily lives with involvement not only within the healthcare and agricultural industries, but also within the environment and energy sectors.
The initial framework for federal regulation of biotechnologies was published in 1986, more than three decades ago.
Significant advances in scientific knowledge and commercialization of that knowledge, as well as the need to remain well-equipped for the future products of biotechnology, spurred the federal government in 2015 to update the regulatory framework.
A 2015 executive memorandum directed the principal biotechnology regulatory agencies—–the Environmental Protection Agency, the Food and Drug Administration, and the U.S. Department of Agriculture (USDA)—to revise existing regulatory framework. Citing advances in the science and technology, the memorandum called for an update to “facilitate the appropriate federal oversight by the regulatory system and increase transparency, while continuing to provide a framework for advancing innovation.”
Last week, the White House Office of Science and Technology Policy released a complete summary of the roles and responsibilities of federal agencies with respect to the regulation, the "2017 Update to the Coordinated Framework for the Regulation of Biotechnology."
The update restates the guiding principles for federal regulation, describes the roles and responsibilities of the primary biotech regulatory agencies, clarifies mechanisms that enable interagency communication and coordination, as well as outlines the timeline and mechanisms for future review and updates to the coordinated framework. The report uses a series of graphs outlining agency areas of responsibilities and case studies to illustrate agency oversight coordination.
The release of the update follows the September 2016 publication of the "National Strategy for Modernizing the Regulatory System for Biotechnology Products." That document sets forth a long-term strategy to ensure the federal regulatory system is prepared to access the risks associated with biotechnology advances while supporting innovation, protecting health and environment, increasing transparency and reducing costs.
The update, together with the strategy, offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.”
Additionally, the White House Office of Information and Regulatory Affairs completed its review of USDA’s proposal, which aims to update those biotechnology products that are subject to the USDA’s oversight. USDA’s proposal would allow for the evaluation of genetically engineered plants for noxious weed risk, and responds to the Food, Conservation and Energy Act of 2008—the 2008 Farm Bill—that mandated USDA’s Animal and Plant Health Inspection Service to “improve the management and oversight of” field trials and environmental releases of genetically engineered organisms.
As the biotechnology field continues to evolve, updates to the federal regulatory process aim to allow for both the unhindered advancement of innovation while ensuring that the federal biotechnology regulatory system remains well-equipped to manage the future products of biotechnology.
Both NCSL’s Natural Resource and Infrastructure Committee and NCSL’s Agriculture Task Force have engaged with members on the issue of biotechnology through informational sessions with federal officials as well as site visits to a number of biotechnology laboratories across the country.
For more information on the coordinated framework, or NCSL’s policy, please contact Kristen Hildreth, or Ben Husch.
Kristen Hildreth is a policy associate with NCSL's National Resources and Infrastructure Committee.