For the purpose of this memo, “biotechnology products” refers to products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. It also covers some of the products produced by such plants, animals, and microbes or their derived products as determined by existing statutes and regulations. Products such as human drugs and medical devices are not the focus of the activities described in this memo.In a briefing document on its blog, the OSTP has described the process ahead:
The goal of the effort is to ensure public confidence in the regulatory system and improve the transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system. Here is a bit more detail about the effort’s three components:A modernized jurisdictional design could address some overlap between the responsible agencies, while also considering newer technologies and their placement into the scheme. For example, new organisms or products from the more recent field of synthetic biology might not fit the traditional category of “genetically engineered” which contemplated a small number of discrete and planned changes into an existing organism. A recent study from the Venter Institute on the regulatory challenges raised by synthetic biology endorsed the basic earlier principle that a product should be evaluated for its own discrete risk profile even when produced through synthetic biology; however, the study notes that specific jurisdictional boundaries between the three federal agencies and specific legal authorities need to be updated to account for an expanding portfolio of genetic engineering modalities that will produce even more novel organisms than the first wave of genetic engineering.
First, the Administration will update the Coordinated Framework, after public input, by clarifying the current roles and responsibilities of the EPA, USDA, and FDA in the regulatory process. This update will help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies.
Second, the Administration will develop a long-term strategy, after public input, to ensure that the Federal regulatory system is well-equipped to assess efficiently any risks associated with the future products of biotechnology. This will include performing periodic horizon-scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system, and creating user-friendly digital tools for presenting the agencies’ authorities, practices, and basis for decision-making.
Third, the Administration will commission an outside, independent analysis of the future landscape of the products of biotechnology. The Administration has already asked the National Academies of Sciences, Engineering, and Medicine to conduct such an analysis.