By Lynn L. Bergeson
On September 10, 2019, the U.S. Office of Science and Technology Policy (OSTP) announced in the Federal Register a request for information (RFI) on the U.S. bioeconomy. Calling for input from all interested parties on the U.S. bioeconomy, OSTP’s RFI aims to inform notable gaps, vulnerabilities, and areas to promote and protect in the bioeconomy that may benefit from federal government attention. Input from the public is welcome, including those with capital investments, those performing innovative research, and those developing enabling platforms and applications in the field of biological sciences. Of particular interest to OSTP are suggestions of areas of greatest priority within the bioeconomy. Comments are due on or prior to October 22, 2019.
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.”
There is still no definitive answer as to whether the green/sustainable chemistry provisions in S. 697, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, will survive the U.S. Senate and House of Representatives conference committee process as lawmakers confer and prepare the final compromise legislation of the Toxic Substances Control Act (TSCA) reform bill. Passed by the Senate on December 17, 2015, S.697 includes sustainable chemistry provisions in Section 27 entitled “Development and Evaluation of Test Methods and Sustainable Chemistry.” The TSCA Modernization Act of 2015 (H.R. 2576), which passed the House of Representatives on June 23, 2015, has no sustainable or green chemistry provisions and takes a much narrower view on TSCA reform. The sustainable chemistry section in S. 697 has been substantially amended from the approach outlined in the previous version of S. 697 passed by the Senate Environment and Public Works Committee in June 2015. These sustainable provisions were initially introduced in May 2015 in a green chemistry bill, S. 1446, by Senator Chris Coons (D-DE) and Senator Susan Collins (R-ME). S. 697 does not include all of the provisions from S. 1446, such as a grant program to fund sustainable chemistry partnerships between industry and universities, and a National Academy of Sciences study, but does include funding, research, and support of green chemistry issues. The sustainable chemistry provisions in S. 697 are as follows:
- The Office of Science and Technology Policy (OSTP) is to convene a National Coordinating Entity (Entity) for Sustainable Chemistry made up of various federal entities and chaired by the Director of the National Science Foundation (NSF) and the U.S. Environmental Protection Agency (EPA) Assistant Administrator for the Office of Research and Development (ORD). The Entity has several duties, including:
- Those related to establishing the Sustainable Chemistry Initiative (described in detail in Section 27(d));
- Development of a national strategy for sustainable chemistry;
- Supporting establishment, through financial, technical, and other assistance, of partnerships between academia, non-governmental organizations, and companies to advance research, training, development of curricular materials and courses, etc.;
- Reporting to Congress two years after enactment of S. 697 on the Entity’s efforts and progress; and
- Submitting an implementation plan for sustainable chemistry to Congress three years after enactment.
Inside EPA has reported that Senator Coons is speaking with key members to allow the provisions to stay in through the compromise conferences. Inside EPA also reported that Senator Coons held a January 13, 2016, Capitol Hill briefing to garner support for the provisions, and that speakers at the briefing outlined the following green chemistry goals:
- To change the way chemists are taught to think about chemistry choices, to include an understanding of toxicology and environmental sciences, so that sustainability considerations inform all chemistry decisions;
- To develop novel chemical products and processes that are less hazardous than, and cost and performance competitive with, traditional technologies;
- To develop a deeper understanding of toxicological properties and mechanisms to inform chemistry decisions and design; and
- To recognize the fundamental limitations related to material selection and move to renewable or abundant resources as starting materials.
More information on S. 697 and how it compares with the previous version of the bill as well as with H.R. 2576 are available in Bergeson & Campbell, P.C.’s (B&C®) memorandum TSCA Reform: Detailed Summary of Key Changes in Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) as Compared with S. 697 Passed by Senate EPW in June. Please also see B&C’s 2016 Forecast memorandum Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2016 for further analysis and discussion of likely legislative next steps regarding TSCA reform.