On July 2nd, the White House issued an executive memorandum on “Modernizing the Regulatory System for Biotechnology Products.”
The modernization effort will apply to “biotechnology products” defined as “products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes.” It will not affect regulation of drugs or medical devices produced using biotechnology.
The memorandum calls on the relevant federal agencies – FDA, USDA, and EPA — to update the federal government’s Coordinated Framework for the Regulation of Biotechnology. The Coordinated Framework was created in 1986 and updated in 1992.
According to the White House, “while the current regulatory system for products of biotechnology effectively protects health and the environment,” it imposes unnecessary burdens on small and mid-sized companies, and its complexity makes it difficult for the public to understand how biotech products are regulated, thereby undermining public confidence in the safety of biotechnology.
The memorandum calls for creation of a new Biotechnology Working Group that will include representatives of FDA, USDA, EPA, and the Executive Office of the President. The Biotechnology Working Group is given three tasks:
- Develop an updated Coordinated Framework – The goals of the update are to clarify the roles of the federal agencies that regulate biotechnology, establish mechanisms for communication and coordination among those agencies, and improve the transparency, coordination, predictability, and efficiency of the regulatory system while continuing to protect public health and the environment.
- Formulate a long-term strategy to ensure that the regulatory system is able to identify and assess potential risks from future biotechnology products while supporting innovation – This will include “horizon-scanning” for new biotech products every 5 years, developing tools to help small businesses navigate the regulatory system, and creating user-friendly tools to explain the regulatory system to the public.
- Commission an external, independent analysis of the future landscape of biotechnology products — The administration has asked the National Academy of Sciences, Engineering, and Medicine to conduct this analysis.
The working group will issue an annual report on its progress, which will be made public.
In a blog post on July 2nd, the White House Office of Science and Technology Policy emphasized that the administration will be seeking public input on the updated Coordinated Framework and long-term strategy. There will be 3 public meetings during the coming year in different parts of the country, the first to be held in Washington, DC in the fall of 2015. In addition, the updated Coordinated Framework will undergo public notice and comment.
One important purpose of the modernization is to remove unnecessary barriers to innovation, particularly those that prevent small companies and universities from bringing biotech products to market. To overcome these barriers, the long-term strategy should ensure that “product evaluations are risk-based and grounded in the best science available,” establish mechanisms to identify impediments to innovation, and develop tools “for assisting small businesses developing biotechnology products to navigate the regulatory system.”
Another important purpose is to help the public better understand how biotechnology products are regulated. The long-term strategy should develop “a modernized, user-friendly set of tools for presenting the regulatory agencies’ authorities, practices, and bases for decision making” and clearly communicating to the public “how the Federal government uses a risk-based, scientifically sound approach” to regulate biotechnology products.
Under the current regulatory system, FDA, USA, and EPA regulate different aspects of biotechnology products. USDA’s Animal and Plant Health Inspection Service (APHIS) regulates the field testing, movement, and importation of biotech crops. FDA regulates biotech foods. FDA requires a food additive approval for biotech plant foods only if they differ significantly in composition from their conventional counterparts, but FDA does require pre-market approval for genetically engineered animals which are regulated as new animal drugs. EPA regulates genetically engineered microorganisms and crops that contain pesticides.
