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”:
- 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 February 27, 2017, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced the publication of the Biorefinery Optimization Workshop Summary Report. The report provides an overview of the discussion on industry challenges and opportunities that took place during the October 2016 Biorefinery Optimization Workshop in Chicago, Illinois. The workshop, which comprised a combination of presentations and breakout sessions, focused on feedstock and materials handling; process scale-up, intensification, and cost reduction; and co-product and waste stream monetization. Discussions from the breakout sessions include key findings on best practices, lessons learned, challenges, potential solutions, and resources needed to overcome current challenges.
On September 7, 2016, the Biotechnology Innovation Organization (BIO) released the report "Advancing the Biobased Economy: Renewable Chemical Biorefinery Commercialization, Progress, and Market Opportunities, 2016 and Beyond." This report documents substantial growth in the renewable chemical industry, and covers domestic policies impacting renewable chemical commercialization. Policy drivers that are explored include the Renewable Fuel Standard (RFS), the 2014 Farm Bill, draft legislation, state and federal tax incentives, and the Master Limited Partnerships Parity Act (MLP). The report also reviews currently operating biorefineries to identify biotechnology solutions beyond biofuels currently undergoing commercial development.
On September 5, 2016, a group of non-profits, including Oxfam International, Fern, and Greenpeace, published a report outlining policy measures that should be taken by the European Commission (EC) to ensure that bioenergy is as low-carbon and resource efficient as possible. The report, "A New EU Sustainable Bioenergy Policy Report," was published after EC stated a willingness to listen to new proposals to improve sustainable bioenergy policies. EC is planning on proposing an updated bioenergy sustainability policy for the use of biomass in heating, electricity, and transport by the end of 2016, as part of the Climate and Energy Package for 2030. To ensure the sustainability of new bioenergy policies, the report discusses the need and practicality of implementing the following safeguards:
- A limit to the use of biomass for energy production to levels that can be sustainably supplied;
- An efficient and optimal use of biomass resources, in line with the principle of cascading use;
- Robust and verifiable emission savings on the basis of correct carbon accounting for bioenergy emissions; and
- A comprehensive, binding set of environmental and social sustainability criteria.
This report proposed sustainability criteria across all energy uses of biomass that has been grown on land, as well as residues, waste, and side-products, but not for biomass from aquaculture and marine areas.
On August 18, 2016, the U.S. Environmental Protection Agency's (EPA) Office of Inspector General (OIG) released a report stating that EPA has not complied with federal requirements to study the effects of the Renewable Fuel Standard (RFS). The report, "EPA Has Not Met Certain Statutory Requirements to Identify Environmental Impacts of Renewable Fuel Standard," found that while EPA is required to provide a report to Congress every three years on the impact of biofuels, there has not been a report since 2011. It was also determined that EPA's Office of Air and Radiation has not analyzed or addressed any negative air quality impacts of RFS despite anti-backsliding requirements, and that EPA has not followed through on a commitment to update a 2010 lifecycle analysis (LCA).
EPA has stated that it plans to complete a report on the impact of the RFS by the end of 2017, and has agreed to corrective actions and timelines to address the rest of the issues brought up in the report. Environmental groups expect that the land-use change models used in the new study will show that the environmental impacts of biofuel production will outweigh the benefits of biofuels. Bob Dinneen, President of the Renewable Fuels Association (RFA) disagrees, stating that the RFA is confident that the new studies "will show that biofuels like ethanol are significantly reducing greenhouse gas emissions, even above the threshold reductions." Reevaluating the environmental impact of the RFS with newer science is critical for all fuel stakeholders, as well as for EPA to make well-informed policy decisions going forward.
Last week, DOE released the 2016 Billion-Ton Report: Advancing Domestic Resources for a Thriving Bioeconomy, Volume 1: Economic Availability of Feedstocks (BT16). Jonathan Male, Director of the Bioenergy Technologies Office (BETO), introduced the report, stating:
While bioenergy currently is the greatest single source of renewable energy in the United States, there are still economic and technological barriers that limit efforts to mobilize biomass resources for more biofuels, biopower, and bioproducts. Energy crops in particular are wholly dependent on future market demand.
BT16 is not a final answer, but rather a step to help the nation develop strategies for realizing a broader bioeconomy potential. At bioenergykdf.net, the reader can find online companion data sets and interactive visualization for all biomass resources in this report. While we are confident in the rigor and depth of our analysis, the potential implications of our results have only begun to be assessed. We invite the user community to take a step forward and use this report and associated data to perform further analyses, ask more questions, and inform strategies to mobilize national biomass resources toward realization of a bioeconomy.
In addition to identifying potential biomass resources, BT16 addresses key aspects of the bioeconomy, including: economic availability of biomass resources; supply impact of algae, waste, and other energy crops; and economic impacts of transportation costs of feedstocks for biorefineries.
On February 18, 2016, at the Advanced Bioeconomy Leadership Conference 2016 (ABLC2016), Dr. Catherine Woteki, Chief Scientist and Undersecretary for Research, Education, and Economics at the U.S. Department of Agriculture (USDA), announced the release of the Federal Activities Report on the Bioeconomy. The report was created to share current federal agency activities that help to develop and support the bioeconomy. The report first introduces the importance of fostering the bioeconomy and the purpose of the Biomass Research & Development Board. From there the report covers all research, loan, and other projects that federal agencies are currently engaged in. The agencies covered in this report are:
- The U.S. Department of Energy (DOE);
- The U.S. Environmental Protection Agency (EPA);
- The U.S. Department of the Interior (DOI);
- The National Science Foundation (NSF);
- The U.S. Department of Defense (DOD);
- The U.S. Department of Transportation (DOT); and
- The Executive Office of the President of the United States.
The July 20, 2015, Federal Register includes a notice for direct final action to amend the electronic reporting regulations for Section 5 under the Toxic Substances Control Act (TSCA). The U.S. Environmental Protection Agency (EPA) action goes into effect on January 19, 2016, unless adverse comments are received by August 19, 2015. The rule requires the use of new electronic premanufacture notice (e-PMN) software that is reportedly easier to use. The rule also adds the requirement that "bona fide intents to manufacture" submissions be made electronically, and changes the procedure for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA. This action is intended to further streamline and reduce the administrative costs and burdens of TSCA Section 5 notifications for both industry and EPA.
On October 21, 2014, the Biobased and Renewable Products Advocacy Group (BRAG®) submitted petitions to the U.S. Environmental Protection Agency (EPA) requesting that biodiesel fuel manufacturers be granted the same Chemical Data Reporting (CDR) exemptions that petroleum-based diesel manufacturers already receive. BRAG made its petitions through two mechanisms allowed under Toxic Substances Control Act (TSCA) rules. BRAG's petitioning of EPA was reported in the Bloomberg BNA Daily Environment Report story "Biobased Diesel Companies Petition EPA For Rules Comparable To Traditional Diesel."
One petition, "Section 21 Petition for Section 8(a) Partial Exemption in Chemical Data Reporting for Biodiesel Products," was submitted to EPA Administrator Gina McCarthy requesting that EPA initiate a rulemaking to amend the TSCA Section 8 CDR partially exempted chemical list set forth in the EPA regulations at 40 C.F.R. Section 711.6(b)(1), referred to as the (b)(1) List. Specifically, BRAG petitioned EPA to add "biodiesel" as a chemical category for partial exemption for the same reasons as those given for petroleum chemicals already included, which occurred via a rulemaking process based on proposals submitted by the American Petroleum Institute (API). BRAG contends that biodiesel products should be treated similarly to the petroleum products included in the (b)(1) List due to the conditions of manufacture and the properties and uses of the substances.
The second petition, "Petition for Partial Exemption of Biodiesel Products," was submitted to the CDR Coordinator of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP). In it, BRAG petitions to add "biodiesel" as a chemical category in the partially exempted chemical list at 40 C.F.R. Section 711.6(b)(2)(iv), referred to as the (b)(2) List. EPA has stated that CDR processing and use information for chemicals on the (b)(2) List is of "low current interest" and has established a petition process to enable stakeholders to add chemicals to the (b)(2) list.
BRAG believes biodiesel belongs on the (b)(1) List but because there is no formal petition process to amend the (b)(1) List, it decided to proceed with the "low current interest" petition process to amend the (b)(2) List as well.
Amending the CDR partial exemption list to include biodiesels is necessary to ensure equitable regulatory treatment of chemical substances of comparable release and exposure potential, and to avoid EPA providing regulatory relief to one subset of diesel products over another -- even though both meet the decision conditions identified by EPA in its final rulemaking to amend the (b)(1) List, especially in light of EPA's stated objectives and interest in sustainable technologies in general, and ongoing programs that engage biodiesel producers in particular.
Regarding the petitions, BRAG's Executive Director Kathleen M. Roberts stated: "We hope EPA recognizes that these petitions only seek to level the playing field for biodiesel and petroleum-derived diesel manufacturers. Under current regulation, biodiesel producers are required to spend significant amounts of time and money gathering and providing CDR information to EPA while petroleum-derived producers are not, for chemicals that are very similar, serve the same purpose, and are managed in equivalent ways."
On May 28, 2014, policy researchers from the J. Craig Venter Institute (JCVI), the University of Virginia, and EMBO released a report on challenges faced by regulators with the increased use of more sophisticated synthetic biology technologies to engineer plants and microbes. According to the press release on the report, "[t]he authors conclude that while the United States governmental agencies tasked with oversight of products derived through synthetic biology have adequate legal jurisdiction to address most, but not all, environmental, health and safety concerns, several key issues could challenge these agencies including: the advent of newer plant engineering technologies that are outside the authority of some agencies, and increased use of more complex engineered microbes that could overwhelm regulators both from a science and safety review and increasing cost perspective." A copy of the press release on the report issued by JCVI is available online. A copy of the full report is available at online.
On May 29, 2014, the Woodrow Wilson Center's Synthetic Biology Project and the Massachusetts Institute of Technology released a report entitled "Creating a Research Agenda for the Ecological Implications of Synthetic Biology." The report suggests key research areas for government agencies, including species for comparative research; phenotypic characterization; fitness, genome stability and lateral gene transfer; control of organismal traits; monitoring and surveillance; modeling; and standardization of methods and data. A copy of the press release on the report is available online. A copy of the full report is available online.