On Monday, September 12th, President Biden signed an Executive Order entitled "Advancing Biotechnology and Biomanufacturing Innovation for Sustainable, Safe and Secure American Bioeconomy."
The Executive Order (in Section 1) set forth policy goals of taking a "whole-of-government" approach for using biotechnology in areas including "health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security" while ensuring equitable access and ethical practices to develop technologies, products and processed that "benefits all Americans and the global community and that maintains United States technological leadership and economic competitiveness." It cites as lessons of the COVID-19 pandemic that biotechnology and biomanufacturing had a "vital role" in "developing and producing life-saving diagnostics, therapeutics, and vaccines that protect Americans and the world" that was also relevant for "achiev[ing] our climate and energy goals, improv[ing] food security and sustainability, secur[ing] our supply chains, and grow[ing] the economy across all of America."
These goals will require investment in "foundational scientific capabilities," including genetic engineering, bioinformatics, and scale-up needed to reduce obstacles to commercialization of these technologies. Concomitant with these efforts to exploit these technologies, the Order recognizes the need to "reduce biological risk" and for biosafety and biosecurity, including from foreign adversaries and strategic competitors using means legal and illegal to acquire U.S technologies and data in this arena.
Specifically, the Order contains directives for the Federal government to:
• Invest and coordinate research and development in biotechnology and biomanufacturing;
• Foster a secure and ethical "biological data ecosystem";
• Improve and expand production capacity while accelerating translation of basic research to commercial products;
• Increase biomass production and "climate-smart" incentive for agriculture;
• Expand market opportunities for bioenergy;
• Train a workforce to create, develop, and implement advances in biotechnology and biomanufacturing;
• Clarify and streamline regulations and make biological risk management a "cornerstone" of biotechnology and biomanufacturing R&D;
• Promote standard and establish metrics to better inform policy, decision-making and investment;
• Develop approaches for risk and threat assessment in partnership with private industry; and
• Engage with the rest of the world to enhance cooperation.
The agencies and functionalities of the Federal government specifically recited in Section 2 of the Order to be responsible for develop and implement these goals include the "Assistant to the President for National Security Affairs (APNSA), in consultation with the Assistant to the President for Economic Policy (APEP) and the Director of the Office of Science and Technology Policy (OSTP)." The process will include the Secretaries of Health and Human Services, Energy, Agriculture, Commerce, and the Director of the National Science Foundation, who will within 180 days of the order submit reports on "biotechnology and biomanufacturing to further societal goals related to health, climate change and energy, food and agricultural innovation, resilient supply chains, and cross-cutting scientific advances." These Reports will also involve the Office of Management and Budget and the Assistant to the President for Domestic Policy.
Specifically, these agencies and functionalities will provide these Reports (as set forth in Section 3 of the Order):
• From the Department of Health and Human Services, the Report will assess "how to use biotechnology and biomanufacturing to achieve medical breakthroughs, reduce the overall burden of disease, and improve health outcomes."
• From the Department of Energy, the Report will assess "how to use biotechnology, biomanufacturing, bioenergy, and biobased products to address the causes and adapt to and mitigate the impacts of climate change, including by sequestering carbon and reducing greenhouse gas emissions."
• From the Department of Agriculture, the Report will assess "w 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."
• From the Department of Commerce, the Report will assess "how to use biotechnology and biomanufacturing to strengthen the resilience of United States supply chains" in consultation with the Secretaries of Defense and HHS and "other appropriate agencies."
• From the Director of the National Science Foundation, the Report will "identify[] high-priority fundamental and use‑inspired basic research goals to advance biotechnology and biomanufacturing and to address the societal goals identified in this section."
And 100 days after receiving these Reports, the Director of OSTP, coordinating with the Director of OMB, the APSNA, the APEP, the APDP and "other appropriate agencies" shall develop an implementation plan for these recommendations. The Director of OMB is charged to provide within 90 days of the Order a budget that identifies the "existing levels of agency spending" to "inform the development of the implementation plan." The agencies and functionalities identified as being responsible for these implementing actions are charged with reporting the "measures taken and resources allocated to enhance biotechnology and biomanufacturing, consistent with the implementation plan" within 2 years of the Order.
The Order in Section 4 also announces a "Data for the Bioeconomy" Initiative to "ensure that high-quality, wide-ranging, easily accessible, and secure biological data sets can drive breakthroughs for the United States bioeconomy." As part of this Initiative, the Order provides for a Report to be provided within 240 days of the Order date that identifies the "most critical" information, provides a plan for "fill[ing] data gaps" and making these data "findable, accessible, interoperable, and reusable." This Report is also charged with identifying "security, privacy, and other risks" and ways of mitigating or preventing them, including cybersecurity efforts involving the Department of Homeland Security.
The Order further provides in Section 5 for efforts to expand domestic biomanufacturing capacity and "mitigate risks posed by foreign adversary involvement in the biomanufacturing supply chain," the Order identifying the departments, agencies, and functionalities charged with developing these strategies. The Order imposes a one-year deadline for a plan to "support the resilience of the United States biomass supply chain for domestic biomanufacturing and biobased product manufacturing" and a 180-day deadline for the Department of Homeland Security to provide vulnerability assessments for "critical infrastructure" associated with the bioeconomy and enhance coordination within the industry on "threat information sharing, vulnerability disclosure, and risk mitigation for cybersecurity and infrastructure risks to the United States bioeconomy."
Section 6 relates to biobased product procurement by federal agencies, and Section 7 sets forth goals for developing the biotechnology and biomanufacturing workforce, which include expanding training and educational opportunities by, inter alia, coordinating Federal education and training programs by the appropriate Federal departments (e.g., Education and Labor) and agencies, and specifically recites that such efforts will include "Historically Black Colleges and Universities, Tribal Colleges and Universities, and Minority Serving Institutions."
Section 8 is directed to improving clarity and efficiency of regulations relating to biotechnology and biomanufacturing, specifically aimed at "ambiguity, gaps, or uncertainties" in Federal regulations including the January 2017 Update to the Coordinated Framework for the Regulation of Biotechnology and Executive Order 13874 of June 11, 2019 (Modernizing the Regulatory Framework for Agricultural Biotechnology Products). This Section also provides that "general public plain-language information" be provided to the public for any of these regulations, as well as plans for regulatory reform, and improvements on the Unified Website for Biotechnology Regulation.
Section 9 concerns establishment of a Biosafety and Biosecurity Innovation Initiative intended to "reduce biological risks associated with advances in biotechnology, biomanufacturing, and the bioeconomy." Section 10 directs the Chief Statistician, the Department of Commerce, the Director of NIST and other agencies to measure the bioeconomy with regard to the economic value to the U.S. economy. Section 11 directs the Director of National Intelligence to be the leader of an interagency effort to provide a comprehensive assessment of "ongoing, emerging, and future threats to United States national security from foreign adversaries against the bioeconomy and from foreign adversary development and application of biotechnology and biomanufacturing, including acquisition of United States capabilities, technologies, and biological data."
Finally, Section 12 directs the Department of State and other agencies to engage with foreign partner governments to "enhance cooperation," "develop joint training arrangements and initiatives," "promote open sharing of scientific data," specifically including genetic data, "anticipate threats to the global bioeconomy, including national security threats," "develop . . . biosafety and biosecurity best practices," and "align international classifications of biomanufactured products."
As with almost everything done by the Federal government, this ambitious program will be subject to the vagaries of implementation, the political process, and the ever-present law of unintended consequences. But the Order illustrates one of the benefits and consequences of having government with an Executive Branch that is capable of directing the efforts of the Federal government to establish and achieve broad policy goals. The devil (insofar as there is or will be one) will be in the details, but for now there has been a decision to emphasize, support, and invest in the bioeconomy that is forward-looking and visionary. Which should be a good thing.
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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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