The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

On March 15, 2017, the National Aeronautics and Space Administration (NASA) published the results of a joint study with German and Canadian agencies on the impact of biofuels on jet engine pollution, including emissions and contrail formation.  The results demonstrate that the use of a 50-50 blend of aviation fuel and fuel of hydro processed esters and fatty acids from camelina plant oil reduced particle emissions by 50-70 percent.  Since soot emissions are a major driver of contrail formation, the particle reductions observed with the use of biofuel are expected to result in a reduced concentration of ice crystals in the contrails, thus, minimizing the impact of the contrails on the environment.  NASA plans to continue to study and demonstrate the potential benefits of biofuels, particularly on their proposed supersonic X-plane.

 

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, 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, including one presented by Lynn L. Bergeson; 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.

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”:

  1. 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. 
  2. 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. 
  3. 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.  

Commentary

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.


 

On October 27, 2014, President Obama announced new plans to strengthen the manufacturing sector. One of the listed plans involved the Departments of Defense, Energy, and Agriculture, and the National Aeronautics and Space Administration (NASA) coming together to invest in advanced materials, advanced sensors, and digital manufacturing. These three areas were determined to be critical to U.S. competitiveness and include biobased materials in the advanced materials category. Over $300 million is going to be invested across the three categories and the research investments by the federal government are expected to be matched by efforts in the private sector. More information about the announcement can be found in the statement released by the Office of the Press Secretary.