President Biden has identified the next areas of focus in his efforts to protect America’s technological leadership and economic competitiveness: biotechnology, biomanufacturing, and the bioeconomy.
Executive Order 14081 (EO), issued September 12, 2022, establishes a National Biotechnology and Biomanufacturing Initiative, a package of targeted investments in biotech research, increased funding for biotech workforce development, expanded support for biomanufacturing and streamlined regulations to remove barriers to the biotechnology sector.
Kicking off its September 14 Biotechnology and Biomanufacturing Summit, the White House announced investments of more than $2 billion to implement the initiative, noting that “Biotechnology and biomanufacturing … can be used to improve our climate and Meet energy goals, improve food security and sustainability, secure our supply chains, and grow economies across America.”
background
The EO defines “biotechnology” broadly as technology related to or enabled by innovation or product development in the life sciences, and “biomanufacturing” as the use of biological systems to develop products, tools and processes on a commercial scale. The EO highlights the potential of both biotechnology and biomanufacturing to help achieve societal goals related to health, climate change, energy, food and agricultural innovation, resilient supply chains, and national and economic security. When implementing the EO, agencies are instructed to consult external stakeholders such as industry, academia and non-governmental organizations where appropriate.
EO provisions of particular interest to the agricultural sector include:
reviews and planning
The EO requires the United States Department of Agriculture (USDA), in consultation with other relevant agencies, to produce a report within 180 days assessing “how biotechnology and biomanufacturing can be applied to food and agriculture innovation, including by improving sustainability and land conservation; improving food quality and nutrition; increasing and protecting agricultural yields; protection against plant and animal pests and diseases; and the cultivation of alternative food sources.” The report must also identify the need for fundamental research and technological development as a high priority and opportunities for public-private collaboration. Management must develop an implementation plan within 100 days of receiving the reports, and entities involved in the implementation plan must report back on their efforts within two years.
regulatory reform
As part of the initiative, the USDA is also tasked with developing new regulatory processes that will improve the agency’s ability to accommodate a broader range of innovative products while continuing to prioritize safe agriculture and alternative food innovations. Specifically, the EO requires the USDA, the Environmental Protection Agency, and the Food and Drug Administration to:
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Prepare a report within 180 days that identifies areas of regulatory ambiguity, gaps or uncertainties in the January 2017 Update to the Coordinated Framework for Biotechnology Regulation and policy changes required under Executive Order 13874 (Modernizing the Regulatory Framework for Agricultural Biotechnological Products)
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Provide the public with information in plain language about each agency’s regulatory roles, responsibilities, and processes, including which agency or agencies are responsible for oversight of different types of bioengineered products, within 100 days of the completion of the above report are case studies
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Provide, within 280 days, a plan with processes and timelines to implement regulatory reform, including identifying the regulations and guidance that may be updated, streamlined, or refined, and identifying potential new guidance or regulations as needed
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Within one year, amend the Unified Website for Biotechnology Regulation to incorporate the new information in plain language and allow biotechnology product developers to submit product-specific inquiries and receive promptly a single, coordinated response with, where possible, informal guidance on federal regulations verification process
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Provide an update on progress in implementing these reforms within one year and annually for three years thereafter, identify gaps in legislative authority and recommend implementing measures and legislative proposals to fill the gaps and enhance the clarity and efficiency of the regulatory process for Biotechnology to improve products
programs and funding
Note: The funding announcement and accompanying fact sheets will be folded in some programs launched earlier this year.
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$10 million through the USDA’s Bioproduct Pilot Program to support the growing industry producing sustainable organic products with the goal of providing cost-effective alternatives to conventional everyday products
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$68 million through USDA’s Agriculture and Food Research Initiative to train the next generation of research and education professionals in food and agriculture, including biotechnology (announced March 2022)
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A specialized USDA biosafety and biohazard management certification program to meet the growing need for biosafety professionals in agricultural, veterinary, pharmaceutical or biotechnology facilities (announced August 2022)
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$500 million through a USDA grant program to support innovative and sustainable American fertilizer production (starting summer 2022)
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$32 million in wood innovation and community wood grants from the USDA, combined with an additional $93 million in partner funding for projects that develop new wood products and increase the effective use of US forest resources
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More than $270 million over five years through the Tri-Service Biotechnology for a Resilient Supply Chain program to support the advanced development of bio-based materials, including fuels, for defense supply chains
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Up to $100 million from the US Department of Energy (DOE) for research and development to convert biomass into fuels and chemicals
More than $200 million under the US Economic Development Administration’s Build Back Better Regional Challenge to grow the bioeconomy by fostering regional biotechnology and biomanufacturing programs
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The Sustainable Aviation Fuel (SAF) Grand Challenge, which aims to accelerate the research, development, demonstration and deployment needed to scale production of SAF to 3 billion gallons per year by 2030 and 35 billion per year by 2050 to increase
procurement
Within a year, all federal procurement agencies will be directed to establish a bio-based procurement program with guidelines for qualifying purchases over $10,000. The EO requires annual reporting of bio-based spending and urges authorities to increase spending on organic products.
occasions
The EO outlines a whole-of-government approach that includes a number of executive offices and other agencies, including the U.S. Department of Health and Human Services, the U.S. Department of Commerce, the DOE, the U.S. Department of Transportation, the National Science Foundation, and the U.S. Office of Management and Budget as well external stakeholders from academia, industry, labor unions, state, local and tribal governments, and non-governmental organizations.
At the very least, implementation of the EO guidelines should provide developers with an opportunity to engage with federal regulators on issues relevant to the big AgTech sector, and specifically the biotech sector. Indeed, the EO states that “[f]or biotechnology and biomanufacturing, to help us achieve our societal goals, the United States must invest in basic scientific skills. We must develop genetic engineering technologies and techniques to be able to write circuits for cells and program biology predictably, just as we write software and program computers; unlock the power of biological data, including through computational tools and artificial intelligence; and advancing the science of scale-up manufacturing while lowering the barriers to commercialization so innovative technologies and products can reach markets faster.”
