By Lynn L. Bergeson and Margaret R. Graham
On September 16, 2016, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA), in collaboration with the White House, released two documents that will update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) that was first rolled out by the White House Office of Science and Technology Policy (OSTP) in 1986 and updated in 1992. The White House states that this is “an important step to ensure public confidence in the regulatory system for biotechnology products and to improve the transparency, predictability, coordination, and, ultimately, efficiency of that system.” The documents released are:
The Update document is intended to help product developers and the public understand what the regulatory pathway for products might look like. The White House states that the Update document presents information about agency roles and responsibilities in several forms, including:
- Graphics that illustrate agency-specific overviews of regulatory roles;
- Case studies that demonstrate how a product developer might navigate the regulatory framework, and;
- A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.
The White House is seeking public comment on this proposed Update. The comment deadline will be 40 days from the date of publication in the Federal Register.
The Strategy document, which the White House states “sets forth a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens,” also details many existing activities at EPA, FDA, and USDA; new activities that have been instigated by the memorandum on “Modernizing the Regulatory System for Biotechnology Products,” which directed EPA, FDA, and USDA to update the Coordinated Framework; and key commitments that these three agencies will keep going forward to continue the modernization process. These commitments are:
- EPA, FDA, and USDA will review existing communication tools and, as appropriate, may revise existing or develop new user-friendly sources of regulatory information for product developers and the general public.
- EPA, FDA, and USDA are emphasizing their commitments to interagency communication and collaboration in order to make timely decisions on regulatory jurisdiction for biotechnology products and to optimize the review and use of scientific data for regulatory assessments.
- EPA and FDA intend to clarify their respective approaches for oversight of products developed using genome editing techniques, including, for example, pesticidal products at EPA and genetically engineered animals at FDA.
- EPA, FDA, and USDA will continue to examine their regulatory structures with the goal of clarifying how the U.S. Federal Government will regulate genetically engineered insects in an integrated and coordinated fashion to cover the full range of potential products.
- EPA, FDA, and USDA commit to reporting annually, for at least the next five years, on specific steps that they are taking to implement the Strategy, as well as any additional actions being taken to improve the transparency, predictability, and efficiency of biotechnology regulation and the coordination among the regulatory agencies.
- EPA, FDA, and USDA will continue to provide leadership in international fora to promote scientific competency, understanding of the U.S. regulatory approach, and regulatory compatibility worldwide for biotechnology products.
- EPA, FDA, and USDA commissioned a study by the National Academy of Sciences, entitled “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.” This report is still forthcoming.
On Tuesday, September 20, 2016, at 2:00 p.m. (EDT), OSTP, EPA, FDA, and USDA will be participating in a conference call on the White House’s efforts in regards to the above. More information regarding registration for the call and submitting questions is available online.
More information concerning the Coordinated Framework, the memorandum on “Modernizing the Regulatory System for Biotechnology Products,” and other current biotechnology issues are available in our memoranda on our website under the key phrase “Biobased Products, Biotechnology.”
On September 1, 2016, the Algae Biomass Organization (ABO) announced that the U.S. Environmental Protection Agency (EPA) will be hosting an "Opportunity for Public Comment on Algae Guidance for The Preparation of [Toxic Substances Control Act (TSCA)] Biotechnology Submissions." This meeting will receive public comments on EPA's algae guidance document, and will inform the development of EPA's "Algae Guidance for The Preparation of TSCA Biotechnology Submissions" document. Approximately 120 people will be able to attend in person, with unlimited access via web connect and teleconference. The meeting is scheduled for October 27, 2016, in Tempe, Arizona, immediately following the Algae Biomass Summit. ABO will post a specific time and location when more information becomes available.
On August 8, 2016, the U.S. Department of Energy (DOE) announced an open meeting of the Biomass Research and Development Technical Advisory Committee in the Federal Register. The purpose of the meeting is to develop advice and guidance promoting research and development (R&D) for biofuel and bioproducts production. A tentative agenda includes:
- Update on U.S. Department of Agriculture (USDA) Biomass R&D Activities
- Update on DOE, Office of Energy Efficiency and Renewable Energy (EERE), and Biomass R&D Activities
- Overview of the Commercial Aviation Alternative Fuels Initiative (CAAFI)
- Presentations on Advanced Biodigester Systems
- Overview of OSTP and Its Role on the Biomass Board
The meeting will be held in Madison, WI, on August 17, 2016, from 8:30 a.m. - 6:00 p.m. (CT) and August 18, 2016, from 8:30 a.m. - 12:00 p.m. (CT). A meeting summary will be provided for public review online.
On May 25, 2016, the U.S. Environmental Protection Agency (EPA) announced a public hearing for the proposed rule "Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018." A pre-publication version of the proposed rule is available now, with the proposed rule being published separately in the Federal Register under Docket ID No. EPA-HQ-OAR-2016-0004. The proposed volumes include slight increases in all categories from the 2016 volumes, but still fall short of the volumes proposed for 2017 under Section 211 of the Clean Air Act. The public hearing will be held in Kansas City, Missouri, on June 9, 2016, at 9:00 a.m. (CT). Parties wishing to testify at the hearing should notify the contact person listed below by May 31, 2016:
Office of Transportation and Air Quality
Assessment and Standards Division
U.S. Environmental Protection Agency
2000 Traverwood Drive
Ann Arbor, MI 48105
Telephone number: (734) 214-4131;
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 May 9, 2016, USDA announced a public meeting of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21). AC21 was created to provide the USDA Secretary with information on agriculture biotechnology issues, including the long-term impacts of biotechnology on the U.S. food and agriculture system, and to provide guidance on immediate issues. The AC21 meeting will consider the analysis of the new AC21 charge created by the three ad hoc subgroups; discuss a draft outline for the next committee report, including draft guidance documents for producers and for facilitating local conversations around coexistence; and continue overall discussions on the committee charge and work completion plans. The meeting will be held at the U.S. Access Board Conference Room in Washington, D.C, on June 13 and 14, 2016, from 8:30 a.m. to 5:00 p.m. (EDT) each day. To make oral statements or public comments, the notice states to write to Dr. Schechtman at:
Designated Federal Official
Office of the Deputy Secretary,
202B Jamie L. Whitten Federal Building
12th and Independence Avenue, S.W.
Washington, D.C. 20250
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.