By Lauren M. Graham, Ph.D.
On August 21, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released their interim report titled A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology. The U.S. Department of Defense (DOD) asked NAS to develop the framework to:
- Guide an assessment of the security concerns related to advances in synthetic biology;
- Assess the level of concern warranted for various advances and identify areas of vulnerability; and
- Prioritize options to address these vulnerabilities.
The report provides an overview of the categories of synthetic biology and a set of initial questions aimed at guiding the assessment of concern related to the technologies and applications of the field. The framework outlines factors for assessing the levels of concern that each technology and application presents in terms of malicious use, as well as factors for assessing the capability for mitigation. The final report will use the framework to provide DOD with an assessment of concerns and mitigation options by developing informed answers to the questions posed in the interim report.
By Kathleen M. Roberts
On August 28, 2017, the U.S. Department of Defense (DOD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) issued in the Federal Register a notice of request for public comment on an extension of a previously approved information collection requirement regarding Biobased Procurements. Pursuant to the Federal Acquisition Regulation (FAR) Clause 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts, prime contractors are required to report annually the product types and dollar values of U.S. Department of Agriculture (USDA)-designated biobased products purchased to the System for Award Management (SAM) website. Federal agencies use the submitted information to report annually to the Office of Federal Procurement Policy (OFPP) concerning actions taken to implement and measure progress in carrying out the preference for biobased products required under Section 9002 of the Farm Security and Rural Investment Act of 2002, codified at 7 U.S.C. § 8102.
Comments are due by October 27, 2017. Public comments are invited specifically on:
- Whether the collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility;
- Whether the estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology;
- Ways to enhance the quality, utility, and clarity of the information to be collected; and
- Ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
By Lauren M. Graham, Ph.D.
On June 30, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released the final version of its report Preparing for Future Products of Biotechnology, which is the result of a collaboration by a committee of experts convened by NAS. The report provides an overview of the committee’s discussion on “the future products of biotechnology that are likely to appear on the horizon, the challenges that the regulatory agencies might face, and the opportunities for enhancing the regulatory system to be prepared for what might be coming.” The committee reached consensus on its conclusions and recommendations regarding actions that can be taken to enhance the capabilities of the biotechnology regulatory system to prepare for the anticipated future of biotechnology products, which are also presented in the report.
More information on the NAS report is available in the Biobased and Renewable Product Advocacy Group (BRAG®) blog post “NAS Releases Final Report on Preparing for Future Products of Biotechnology.”
By Lynn L. Bergeson and Margaret R. Graham
On June 30, 3017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making [and] … identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.” This report is a collaboration among a committee of experts including the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee), the Board on Life Sciences, the Board on Agriculture and Natural Resources, the Board on Chemical Sciences and Technology, and the Division on Earth and Life Studies and sponsored by the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA). Lynn L. Bergeson was an external contributor to the Committee’s deliberations and presented before the Committee on the subject of the biotechnology regulatory system.
The report includes sections on emerging trends and products of biotechnology; the current biotechnology regulatory system; understanding risks related to future biotechnology products; opportunities to enhance the capabilities of the biotechnology regulatory system; and an index on congressionally defined product categories that FDA regulates; as well as conclusions and recommendations that were included in our blog item on the prepublication version.
More information on the regulatory issues of biotechnology products is available on our biobased products blog under key word biotechnology, as well as the Bergeson & Campbell, P.C. (B&C®) regulatory developments website under key phrase biobased products, biotechnology.
By Lynn L. Bergeson and Margaret R. Graham
On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) announced the release (pre-publication version) of a new report: Preparing for Future Products of Biotechnology. Pursuant to the White House Office of Science and Technology Policy's (OSTP) July 2, 2015, memorandum, “Modernizing the Regulatory System for Biotechnology Products,” NAS was tasked with looking into the future and describing the possible future products of biotechnology that will arise over the next five to ten years, as well as providing some insights that can help shape the capabilities within the agencies as they move forward. More information regarding the July 2015 memorandum is available on our website under the key phrase Biobased Products, Biotechnology.
Via an ad hoc committee, the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee), NAS developed this report through several months of gathering and synthesizing information from several sources, including: 74 speakers over the course of three in-person meetings and eight webinars; responses to its request for information from a dozen federal agencies; statements solicited from members of the public at its in-person meetings; written comments through the duration of the study; and recent NAS studies related to future products of biotechnology. Lynn L. Bergeson was an external contributor to the Committee’s deliberations and presented before the Committee on the subject of the biotechnology regulatory system.
The report presents conclusions concerning the future biotechnology products themselves, as well the challenges that federal agencies will face in regulating them, which include:
- The bioeconomy is growing rapidly and the U.S. regulatory system needs to provide a balanced approach for consideration of the many competing interests in the face of this expansion;
- The profusion of biotechnology products over the next five to ten years has the potential to overwhelm the U.S. regulatory system, which may be exacerbated by a disconnect between research in regulatory science and expected uses of future biotechnology products;
- Regulators will face difficult challenges as they grapple with a broad array of new types of bio-technology products -- for example, cosmetics, toys, pets, and office supplies -- that go beyond contained industrial uses and traditional environmental release;
- The safe use of new biotechnology products requires rigorous, predictable, and transparent risk-analysis processes whose comprehensiveness, depth, and throughput mirror the scope, scale, complexity, and tempo of future biotechnology applications.
The report provides three recommendations for federal agencies in responding to these challenges, which it states should be taken to “enhance the ability of the biotechnology regulatory system to oversee the consumer safety and environmental protection required for future biotechnology products”:
- The U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and other agencies involved in regulation of future bio-technology products should increase scientific capabilities, tools, expertise, and horizon scanning in key areas of expected growth of biotechnology, including natural, regulatory, and social sciences.
- EPA, FDA, and USDA should increase their use of pilot projects to advance understanding and use of ecological risk assessments and benefit analyses for future biotechnology products that are unfamiliar and complex and to prototype new approaches for iterative risk analyses that incorporate external peer review and public participation.
- The National Science Foundation, the Department of Defense, the Department of Energy, the National Institute of Standards and Technology, and other agencies that fund bio-technology research with the potential to lead to new biotechnology products should increase their investments in regulatory science and link research and education activities to regulatory-science activities.
The report is well-written and contains an impressive amount of new, relevant, and important information. The Committee participants are to be commended for an important new piece of scholarship in this area.
The report’s conclusions are also significant, but not entirely unexpected. For those of us working in this space, we have recognized for years the lack of clarity regarding jurisdictional boundaries, the paucity of government resources, and the urgent need for regulatory clarity and significantly enhanced funding. Unfortunately, given current Trump Administration efforts to diminish government funding for EPA, FDA, and elsewhere, the well-crafted and spot-on recommendations may tragically fall on deaf ears. Shareholders should carefully review the report and work hard to ensure the recommendations are implemented. The consequences of failing to “increase scientific capabilities, tools, expertise, and horizon scanning in key areas of expected growth of biotechnology, including natural regulatory, and social sciences” -- the number one recommendation in the report -- are too great to ignore.
On January 31, 2017, two bills were introduced in the U.S. Congress that propose to reform the Renewable Fuel Standard (RFS) and the national biofuels mandate. The first bill would require the National Academy of Sciences (NAS) to assess the performance, safety, and environmental impact of mid-level ethanol, and the implications of the use of mid-level ethanol blends compared to gasoline blends containing ten percent or less ethanol. The second bill would reduce the U.S. Environmental Protection Agency’s (EPA) cellulosic biofuel volume requirements under the RFS program to what is commercially available pending a NAS report on the environmental and economic impacts and feasibility of large scale production of cellulosic biofuel.
On August 2, 2016, Lynn L. Bergeson, Managing Partner of B&C, presented the webinar "New TSCA's Impact on Biotechnology," with the National Academies of Sciences, Engineering, and Medicine (NAS). This webinar, available for free on the NAS website, includes an overview of TSCA updates resulting from the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Ms. Bergeson focused specifically on how these updates could impact the regulation of biotechnology, especially under Sections 3, 4, 5, and 26. Changes include: how EPA defines "conditions of use" and "potentially exposed or susceptible subpopulations," and applies them to intergeneric microorganisms; an expansion of EPA's authority to compel testing; and a requirement for EPA to provide an affirmative determination when reviewing Section 5 notifications.
The National Academies of Sciences, Engineering, and Medicine is hosting a second public meeting examining future biotechnology products on June 1-2, 2016. This two-day meeting will run from 9:00 a.m. - 5:30 p.m. both days, with a public comment period open to in-person attendees at the end of each day. The meeting will be held at the National Academy of Sciences Building in Washington D.C., and members of the public will have the opportunity to observe in person by pre-registering or via live webcast. Registration is available online. Topics covered during the meeting include trends in biotechnology funding, investment, development, and risk analysis.
On April 5, 2016, the National Academies of Science, Engineering, and Medicine (NAS) posted the Agenda for the first open session of its committee on “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.” The Committee is beginning a study to provide an independent and objective examination of the future products of biotechnology, as commissioned pursuant to the White House Office of Science and Technology Policy’s (OSTP) July 2, 2015, memorandum, “Modernizing the Regulatory System for Biotechnology Products.” The first Committee meeting is scheduled for April 18, 2016, from 1:00 p.m. - 5:00 p.m. (EDT).
According to the Agenda, the speakers for the April 18 meeting include representatives from the study sponsors: the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and OSTP. The Chair of the Committee, Richard Murray, and the Study Director, Douglas Friedman, will be providing the welcoming remarks and introduction.
Registration, available online, is strongly encouraged for in-person attendance and for viewing the webcast. A limited public comment period will be offered to in-person registrants only. A sign-up sheet will be available at the meeting starting at noon on April 18. The Committee will accept written comments and materials over the course of the study via input form on the study’s website.
The Committee members have been appointed, but will only be confirmed once the formal comments on the appointments, which were due April 6, 2016, have been reviewed. The Committee members’ biographies are available online. More information regarding the study and the Committee appointees is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum NAS to Study Future Products of Biotechnology.