OSTP Publishes RFIs on Coordinated Framework for the Regulation of Biotechnology and National Biotechnology and Biomanufacturing Initiative
By Lynn L. Bergeson and Carla N. Hutton
As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) published two requests for information (RFI) related to the NBBI. In the first one, OSTP, on behalf of the primary agencies that regulate the products of biotechnology -- the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) -- requests relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products. 87 Fed. Reg. 77900. According to the RFI, the information provided will inform regulatory agency efforts to improve the clarity and efficiency of the regulatory processes for biotechnology products. The RFI includes the following questions:
- Describe any ambiguities, gaps, inefficiencies, or uncertainties regarding statutory authorities and/or agency roles, responsibilities, or processes for different biotechnology product types, particularly for product types within the responsibility of multiple agencies.
- Describe the impact, including economic impact, of these ambiguities, gaps, inefficiencies, or uncertainties.
- Provide any relevant data or information, including case studies, that could inform improvement in the clarity or efficiency (including the predictability, transparency, and coordination) of the regulatory system and processes for biotechnology products.
- Describe any specific topics the agencies should address in plain language on the regulatory roles, responsibilities, and processes of the agencies.
- Describe any specific issues the agencies should consider in developing a plan to implement regulatory reform, including any updated or new regulations or guidance documents.
Describe any new or emerging biotechnology products (e.g., microbial amendments to promote plant growth; food plants expressing non-food substances or allergens from non-plant sources) that, based on lessons learned from past experiences or other information, the agencies should pay particular attention to in their evaluation of ambiguities, gaps, or uncertainties regarding statutory authorities and/or agency roles or processes.
Describe any new or emerging categories of biotechnology products on the horizon that the regulatory system and processes for biotechnology products should be preparing to address. Describe any specific recommendations for regulating these new or emerging categories of biotechnology products to guide agency preparations.
What is the highest priority issue for the agencies to address in the short term (i.e., within the next year) and in the long term.
OSTP, EPA, FDA, and USDA will host a virtual public listening session on January 12, 2023. The virtual listening session will allow OSTP, EPA, FDA, and USDA to hear, firsthand, from stakeholders who wish to provide feedback on any of the seven questions outlined in the RFI. Comments are due on or before 5 p.m. (EST) February 3, 2023. More information on the Coordinated Framework for the Regulation of Biotechnology is available in our January 9, 2017, memorandum.
The second RFI seeks public input on how advances in biotechnology and biomanufacturing can help achieve goals that were previously out of reach and what steps can be taken to provide the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. 87 Fed. Reg. 77901. OSTP invites input from interested stakeholders, including industry and industry association groups; academic researchers and policy analysts; civil society and advocacy groups; individuals and organizations that work on biotechnology, biomanufacturing, or related topics; and members of the public. OSTP seeks responses to one, some, or all of the following questions:
Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals
- For any of the four categories outlined above (health, climate and energy, food and agriculture, and supply chain resilience):
- What specific bold goals can be achieved through advances in biotechnology and biomanufacturing in the short term (five years) and long term (20 years)? In your answers, please suggest quantitative goals, along with a description of the potential impact of achieving a goal. Listed below are illustrative examples of quantitative goals:
- Develop domestic bio-based routes of production, including the entire supply chain, for X percent of active pharmaceutical ingredients.
- Utilize X tons of sustainable biomass annually as input to biomanufacturing processes to displace Y percent of U.S. petroleum consumption.
- What R&D is needed to achieve the bold goals outlined in (a), with a focus on cross-cutting or innovative advances? How would the government support this R&D, including through existing federal programs, creation of new areas of R&D, and/or development of new mechanisms?
- How else can the government engage with and incentivize the private sector and other organizations to achieve the goals outlined in (a)?
- Public engagement and acceptance are of critical importance for successful implementation of biotechnology solutions for societal challenges. How might social, behavioral, and economic sciences contribute to understanding possible paths to success and any hurdles? What public engagement and participatory models have shown promise for increasing trust and understanding of biotechnology?
Data for the Bioeconomy
What data types and sources, to include genomic and multiomic information, are most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D? What data gaps currently exist?
How can the federal government, in partnership with private, academic, and non-profit sectors, support a data ecosystem to drive breakthroughs for the U.S. bioeconomy? This may include technologies, software, and policies needed for data to remain high-quality, interoperable, accessible, secure, and understandable across multiple stakeholder groups.
Building a Vibrant Domestic Biomanufacturing Ecosystem
What is the current state of U.S. and global biomanufacturing capacity for health and industrial sectors, and what are the limits of current practice?
What can the federal government do to expand and scale domestic biomanufacturing capacity and infrastructure? What level of investment would be meaningful, and what incentive structures could be employed?
What are barriers that must be addressed to enable better domestic supply chains for biomanufacturing (e.g., feedstocks, reagents, consumables)?
How can the federal government partner with state and local governments to expand domestic biomanufacturing capacity, with a particular focus on underserved communities?
Biobased Products Procurement
What are new, environmentally sustainable biobased products that the federal government could purchase through its BioPreferred Program? How can the federal government incentivize development of new categories of sustainable biobased products?
Biotechnology and Biomanufacturing Workforce
How can the U.S. strengthen and expand the biotechnology and biomanufacturing workforce to meet the needs of industry today and in the future? What role can government play at the local, state, and/or federal level?
What strategies and program models have shown promise for successfully diversifying access to biomanufacturing and biotechnology jobs -- including those involving Historically Black Colleges and Universities (HBCU), Tribal Colleges and Universities, and other Minority Serving Institutions? What factors have stymied progress in broadening participation in this workforce?
Reducing Risk by Advancing Biosafety and Biosecurity
- What can the federal government do to support applied biosafety research and biosecurity innovation to reduce risk while maximizing benefit throughout the biotechnology and biomanufacturing life cycles?
- How can federal agencies that fund, conduct, or sponsor life sciences research incentivize and enhance biosafety and biosecurity practices throughout the United States and international research enterprises?
Measuring the Bioeconomy
What quantitative indicators, economic or otherwise, are currently used to measure the contributions of the U.S. bioeconomy? Are there new indicators that should be developed?
How should the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS) be revised to enable characterization of the economic value of the U.S. bioeconomy? Specifically, which codes or categories do not distinguish between functionally identical biobased and fossil fuel-based commodities?
- What are opportunities for the U.S. government to advance R&D, a skilled workforce, regulatory cooperation, and data sharing for the bioeconomy through international cooperation? Which partnerships and fora are likely keys to advance these priority areas?
- What risks are associated with international biotechnology development and use, and how can the U.S. government work with allies and partners to mitigate these risks?
Comments are due on or before 5:00 p.m. (EST) on January 20, 2023.