March 9, 2017
Good morning. Welcome to the release of the report Preparing for Future Products of Biotechnology, from the National Academies of Sciences, Engineering, and Medicine.
The life sciences are accelerating at an unprecedented pace, in part due to new tools such as CRISPR-Cas9 that make genome engineering faster, easier, and less costly. These advances could lead to an explosion in new biotechnology products. While some see the promise for biotechnology to address social or environmental issues, others have expressed concerns about the safety and ethics of biotechnology products. Over the next decade, the U.S. regulatory system will need to anticipate these new developments and achieve a measured approach to assessing the potential benefits and risks as it seeks to manage biotechnology products and their use.
The National Academies have a long history of providing evidence-based advice and guidance on fast-developing areas of biotechnology and genetic research. In the past year, we have conducted studies of advanced chemical manufacturing using genetic engineering techniques, gene drives in non-human organisms, the latest science on genetically engineered crops, and the science, ethics, and governance of human genome editing. Today’s report is part of this broader suite of activities and will make an important contribution to this body of work.
The committee that conducted the study and wrote the report was asked to identify likely future products of biotechnology in the next five to 10 years. It was also asked to identify the scientific capabilities, tools, and expertise that the U.S. Food and Drug Administration, the Department of Agriculture, the Environmental Protection Agency, and various regulatory agencies will need in order to formulate sound policies and make timely decisions about these products. The committee was not asked for – and did not provide -- advice or guidance on the regulations or the regulatory framework that the federal government should adopt to oversee new biotechnology products.
To fulfill the study’s statement of task, the Academies appointed committee members with strong expertise in diverse disciplines, including biotechnology regulatory law, agricultural and industrial biotechnology, risk assessment, social science, biochemistry, engineering, entomology, microbiology, and environmental toxicology. In accordance with Academies policies, the committee members were vetted for conflicts of interest and complied with our disclosure policy. The committee slate was also listed for a 20-day public comment period on our current projects website before they were officially appointed.
Because advances in life sciences are being used by the biotechnology industry to develop new products, current industry expertise was needed for this study. For this reason, we granted waivers to two committee members who declared conflicts of interest. Under Section 15 of the Federal Advisory Committee Act, the Academies are permitted to waive conflicts of interest when a committee member’s expertise is needed to conduct the study, despite knowing of their conflicts. The Academies publicly disclosed these conflicts of interest at the start of this study.
During its information gathering process, the committee held three public meetings and eight public webinars, all of which were streamed online and are now archived on our website. In accordance with Academies policy, the committee’s findings and recommendations also underwent extensive independent peer review prior to this release.
On behalf of the Academies, I would like to thank the committee, which served without compensation and worked diligently over many months to produce this important new report. It will strengthen the government’s oversight capabilities for the wide array of new biotechnology products on the horizon.