Biden's Executive Order Focusing on Biotechnology Offers Opportunities for AgTech Industry

Released on September 12, 2022, Executive Order 14081 (EO) 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 reduce barriers for the biotechnology sector.

To kick off its Biotechnology and Biomanufacturing Summit on September 14, the White House announced investments of more than $2 billion to implement the Initiative, noting that “biotechnology and biomanufacturing can … be used to achieve our climate and energy goals, improve food security and sustainability, secure our supply chains, and grow the economy across all of America.”

Background

The EO broadly defines “biotechnology” as technology that applies to or is enabled by life sciences innovation or product development and “biomanufacturing” as the use of biological systems to develop products, tools, and processes at commercial scale. The EO highlights the potential for 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. In implementing the EO, agencies are directed to consult, as appropriate, outside stakeholders such as those in industry, academia, and nongovernmental organizations.

EO provisions of particular interest to the Agriculture sector include:

Assessments and Planning

The EO requires the US Department of Agriculture (USDA), in consultation with other appropriate agencies, to produce a report within 180 days, assessing “how to use biotechnology and biomanufacturing for food and agriculture innovation, including by improving sustainability and land conservation; increasing food quality and nutrition; increasing and protecting agricultural yields; protecting against plant and animal pests and diseases; and cultivating alternative food sources.” The report must also identify high-priority basic research and technology development needs and opportunities for public-private collaboration. Within 100 days after receipt of the reports, the Administration must develop an implementation plan, and within two years, agencies included in the implementation plan must report on their efforts.

Regulatory Reform

Also, as part of the Initiative, the USDA is tasked with developing new regulatory processes that will enhance the agency’s ability to consider a wider range of innovative products, while continuing to prioritize safe innovation in agriculture and alternative foods. Specifically, the EO requires USDA, the Environmental Protection Agency, and the Food and Drug Administration to:

• Within 180 days, produce a report that identifies areas of regulatory ambiguity, gaps, or uncertainties in the January 2017 Update to the Coordinated Framework for the Regulation of Biotechnology and in the policy changes made pursuant to Executive Order 13874 (Modernizing the Regulatory Framework for Agricultural Biotechnology Products)
• Within 100 days of completing the above report, provide to the general public plain-language information regarding the regulatory roles, responsibilities, and processes of each agency, including which agency or agencies are responsible for oversight of different types of products developed with biotechnology, with case studies as appropriate
• Within 280 days, provide a plan, including processes and timelines, to implement regulatory reform, including identification of the regulations and guidance documents that can be updated, streamlined, or clarified and identification of potential new guidance or regulations, where needed
• Within one year, modify the Unified Website for Biotechnology Regulation to include the new plain-language information and to enable biotechnology product developers to submit product-specific inquiries and promptly receive a single, coordinated response with, when possible, informal guidance regarding the Federal regulatory review process
• Within one year, and annually thereafter for three years, provide an update regarding progress in implementing these reforms, identifying gaps in statutory authority, and recommending executive actions and legislative proposals to address the gaps and improve the clarity and efficiency of the regulatory process for biotechnology products

Programs and Funding

Note: The funding announcement and accompanying fact sheets fold in some programs launched earlier this year.

• $10 million through the USDA’s Bioproduct Pilot Program to support the growing sustainable bioproduct manufacturing industry, with a goal of providing low-cost alternatives to conventional everyday products
• $68 million through the USDA’s Agriculture and Food Research Initiative to train the next generation of research and education professionals in food and agricultural disciplines, including biotechnology (announced in March 2022)
• A specialized USDA biosafety and biorisk management certificate program to help fill the growing need for biosafety professionals in agricultural, veterinary, pharmaceutical, or biotech facilities (announced in August 2022)
• $500 million through a USDA grant program to support innovative and sustainable American fertilizer production (begun in the summer of 2022)
• $32 million for wood innovation and community wood grants from the USDA, combined with another $93 million in partner funds, for projects that develop new wood products and increase effective use of US forest resources
• 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
• Up to $100 million from the US Department of Energy (DOE) for research and development for conversion of biomass to fuels and chemicals
• More than $200 million through the US Economic Development Administration’s Build Back Better Regional Challenge to help expand the bioeconomy by advancing regional biotechnology and biomanufacturing programs
• The Sustainable Aviation Fuel (SAF) Grand Challenge, which aims to accelerate the research, development, demonstration, and deployment needed to scale up the production of SAF to 3 billion gallons per year by 2030 and to 35 billion per year by 2050

Procurement

Within one year, all federal procurement agencies are directed to establish a bio-based procurement program with guidelines for qualifying purchases over $10,000. The EO requires annual reporting on bio-based spending and urges agencies to increase spending on bioproducts.

Opportunities

The EO outlines a whole-of-government approach that includes a number of Executive Offices and other agencies, including the US Department of Health and Human Services, the US Commerce Department, the DOE, the US Department of Transportation, the National Science Foundation, and the US Office of Management and Budget, as well as outside stakeholders from academia, industry, labor unions, state, local and tribal governments, and nongovernmental organizations.

At a minimum, implementation of the EO’s directives is likely to provide opportunities for developers to engage with federal regulators on issues of importance to the AgTech sector writ large, and to the biotechnology sector specifically. Indeed, the EO notes that “[f]or biotechnology and biomanufacturing to help us achieve our societal goals, the United States needs to invest in foundational scientific capabilities. We need to develop genetic engineering technologies and techniques to be able to write circuitry for cells and predictably program biology in the same way in which we write software and program computers; unlock the power of biological data, including through computing tools and artificial intelligence; and advance the science of scale-up production while reducing the obstacles for commercialization so that innovative technologies and products can reach markets faster.”

ArentFox Schiff will be monitoring implementation of the EO, including opportunities for stakeholder engagement. If you or your company is interested in providing comments to the relevant agencies tasked with carrying out the EO or in applying for funding through any of the Initiative’s programs, please contact Karen Carr, Cissy Jackson, or the ArentFox Schiff attorney who handles your matters. We’d be pleased to assist.