President Joe Biden has issued an executive order to launch the National Biotechnology and Biomanufacturing Initiative to set forth the Administration’s goals to advance biotechnology and biomanufacturing. The White House later convened this week (September 14, 2022) a Summit on the National Biotechnology and Biomanufacturing Initiative during which cabinet agencies announced new investments and resources, including the US Department of Health and Human Services (HHS), which outlined measures to support biopharmaceutical R&D and manufacturing (see related story, HHS Outlines Actions for New National Biotechnology and Biomanufacturing Initiative).

“Biotechnology harnesses the power of biology to create new services and products, which provide opportunities to grow the United States economy and workforce and improve the quality of our lives and the environment,” said the executive order issued on September 12, 2022. “…Although the power of these technologies is most vivid at the moment in the context of human health, biotechnology and biomanufacturing can also 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.”

Key policy goals outlined in the executive order

The executive order outlines key policy goals in biomanufacturing and biotechnology in support of further developing what the Administration calls the “bioeconomy.” Key objectives are to: (1) bolster and coordinate federal investment in R&D for biotechnology and biomanufacturing; (2) foster a biological data ecosystem that advances biotechnology and biomanufacturing innovation; (3) improve and expand domestic biomanufacturing production capacity and processes while also increasing piloting and prototyping efforts in biotechnology and biomanufacturing to accelerate the translation of basic research results into practice; and (4) train and support a diverse, skilled workforce to advance biotechnology and biomanufacturing.

Additionally, the executive order outlines goals to: (1) clarify and streamline regulations using a science- and risk-based, predictable, efficient, and transparent system to support the safe use of products of biotechnology; (2) elevate biological risk management as a key element of the life cycle of biotechnology and biomanufacturing R&D, including by providing for research and investment in applied biosafety and biosecurity innovation; (3) promote standards, establish metrics, and develop systems to grow and assess the state of the “ bioeconomy” to better inform policy, decision-making, and investments; (4) adopt a proactive approach to assessing and anticipating threats, risks, and potential vulnerabilities (including digital intrusion, manipulation, and exfiltration efforts by foreign adversaries), and by partnering with the private sector and other stakeholders to jointly mitigate risks to protect technology and economic competitiveness; and (5) engage the international community to enhance biotechnology R&D cooperation to support biotechnology and biomanufacturing research, innovation, and product development and use.

The executive order also outlines its goals to advance biomass production and create climate-smart incentives for US-based agricultural producers and forest landowners and to expand market opportunities for bioenergy and bio-based products and services.

Timelines for implementation
The executive order further outlines the timelines for implementing the various policy goals as outlined below.

Biomanufacturing and biotechnology R&D. By March 11, 2023 (180 days from the issuance of the executive order), the Secretaries of relevant federal agencies and departments have to submit to the President reports on biotechnology and biomanufacturing related to health, climate change and energy, food and agricultural innovation, resilient supply chains, and scientific advances. These agencies and departments include the following:

• HHS for a report assessing how to use biotechnology and biomanufacturing to achieve medical breakthroughs, reduce the overall burden of disease, and improve health outcomes (Note: the HHS also issued this week (September 14, 2022) key policy goals under the National Biotechnology and Biomanufacturing Initiative, see related article, HHS Outlines Actions for New National Biotechnology and Biomanufacturing Initiative);
• Department of Energy for a report assessing how to use biotechnology, biomanufacturing, bioenergy, and bio-based products to address the causes and adapt to and mitigate the impacts of climate change, including by sequestering carbon and reducing greenhouse gas emissions;
• Department of Commerce for a report assessing how to use biotechnology and biomanufacturing to strengthen the resilience of US supply chains;
• National Science Foundation for a report identifying high-priority fundamental and use‑inspired basic research goals to advance biotechnology and biomanufacturing.
• Department of Agriculture for a report on food and agriculture innovation.

Once the reports are submitted, other federal entities are required to be involved in implementing the policy recommendations, including by providing specific budget recommendations and implementation plans. The other federal entities involved include: the Director of Office of Science and Technology Policy; the Director of the Office of Management and Budget; the Assistant to the President for National Security Affairs; the Assistant to the President for Economic Policy; and the Assistant to the President for Domestic Policy.

Expanding US-Based Biomanufacturing. The executive order also calls for a plan to increase US-based biomanufacturing. By March 11, 2023 (180 days from the issuance of the executive order), various agency heads are required to develop a strategy that identifies policy recommendations to expand domestic biomanufacturing capacity for products spanning the health, energy, agriculture, and industrial sectors, with a focus on advancing equity, improving biomanufacturing processes, and connecting relevant infrastructure. Agencies involved in this process include:

• Department of Commerce to address challenges in biomanufacturing supply chains and related biotechnology development infrastructure;

• Department of Defense to incentivize the expansion of domestic, flexible industrial biomanufacturing capacity for materials and products used in the defense supply chain;
• Department of Energy to support research to accelerate bioenergy and bioproduct science advances, to accelerate biotechnology and bioinformatics tool development, and to reduce hurdles to commercialization, including through incentivizing the engineering scale-up of promising biotechnologies and the expansion of biomanufacturing capacity;
• National Science Foundation to expand its existing Regional Innovation Engine program to advance emerging technologies, including biotechnology.

Additionally, the executive order specifies that the biomanufacturing strategy should identify actions to mitigate risks posed by foreign adversary involvement in the biomanufacturing supply chain and to enhance biosafety, biosecurity, and cybersecurity in new and existing infrastructure. By March 11, 2023 (180 days from the issuance of the executive order), the Secretary of Homeland Security is required to provide vulnerability assessments of the infrastructure and functions associated with the bioeconomy and enhance coordination with industry on threat information-sharing, vulnerability disclosure, and risk mitigation for cybersecurity and infrastructure risks to the US bioeconomy.

US-based biomanufacturing workforce. By March 31, 2023 (200 days from the issuance of the executive order), various agency heads are required to produce and make publicly available a plan to expand training and education opportunities in biotechnology and biomanufacturing for the US workforce and to recommend new efforts to promote multi-disciplinary education programs. This effort would involve formal and informal education and training (such as opportunities at technical schools and certificate programs), career and technical education, and expanded career pathways into existing degree programs for biotechnology and biomanufacturing. By September 12, 2024 (two years from the issuance of the executive order), federal agencies that support relevant federal education and training programs are required to report to the President the measures taken and resources allocated to enhance workforce development.

Biosafety and Biosecurity Innovation Initiative. The executive order also calls for the launch of the Biosafety and Biosecurity Innovation Initiative to reduce biological risks associated with advances in biotechnology, biomanufacturing, and the bioeconomy. To be established by the HHS Secretary, the initiative would (1) support investments in applied biosafety research and innovations in biosecurity to reduce biological risk throughout the biotechnology R&D and biomanufacturing life cycles; and (2) use federal investments in biotechnology and biomanufacturing to incentivize and enhance biosafety and biosecurity practices and best practices throughout the US and international research enterprises.

By March 11, 2023 (180 days from the issuance of the executive order), the HHS Secretary and the Secretary of Homeland Security are required to produce a plan for biosafety and biosecurity for the bioeconomy, including recommendations to: (1) enhance applied biosafety research and bolster innovations in biosecurity to reduce risk throughout the biotechnology R&D and biomanufacturing life cycles; and (2) use federal investments in biological sciences, biotechnology, and biomanufacturing to enhance biosafety and biosecurity best practices.

Also, by September 12, 2023 (one year from the issuance of the executive order), agencies that fund, conduct, or sponsor life-sciences research are required to report on their efforts to achieve the objectives described by the initiative.

Data for the Bioeconomy Initiative. The executive order also calls for the creation of the Data for the Bioeconomy Initiative to ensure access to high-quality, wide-ranging, easily accessible, and secure biological data sets. By May 10, 2023 (240 days from the issuance of the executive order), the Director of the Office of Science and Technology Policy is required to issue a report that does the following: (1) identifies the data types and sources, to include genomic and multiomic information that are most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D, along with any data gaps; (2) sets forth a plan to fill data gaps and make new and existing public data findable, accessible, interoperable, and reusable in ways that are equitable, standardized, secure, and transparent and that are integrated with platforms that enable the use of advanced computing tools; (3) identifies security, privacy, and other risks, and provides a data-protection plan to mitigate these risks; and (4) outlines the federal resources, legal authorities, and actions needed to support the data initiative.

In addition, the Secretary of Commerce, acting through the Director of the National Institute of Standards and Technology, and in coordination with the HHS Secretary are required to consider bio-related software, including software for laboratory equipment, instrumentation, and data management, in establishing baseline security standards for the development of software sold to the US government.

Bio-based procurement. In addition, the executive order calls for establishing federal procurement programs for bio-based products. By September 12, 2024 (two years from the issuance of the executive order), relevant staff are required to have training for bio-based product purchasing. By March 11, 2023 (180 days from the executive order), procuring agencies are required to report the number and dollar value of contracts that include the direct procurement of biobased products as well as the type of bio-based products to the Director of Office of Management and Budget; this reporting requirement that becomes annual. Procuring agencies will be asked to increase by 2025 the amount of bio-based product obligations or the number or dollar value of biobased-only contracts.

Measuring the bioeconomy. By December 11, 2022 (90 days from the issuance of the executive order), the Secretary of Commerce is required to create a publicly available lexicon for the bioeconomy with the goal of assisting in the development of measurements and measurement methods for the bioeconomy that support uses such as economic measurement, risk assessments, and the application of machine learning and other artificial intelligence tools. Additionally, the Chief Statistician of the US government is required to improve and enhance federal statistical data collection designed to characterize the economic value of the US bioeconomy. Various timelines are specified to achieve this goal.

Security and international engagement. In addition, the Director of National Intelligence is required to make an assessment of ongoing, emerging, and future threats to US national security from foreign adversaries against the bioeconomy. Also, the Department of State, along with other relevant agencies, is required to foster international cooperation with regards to biotechnology and biomanufacturing. Various timelines are specified to achieve these goals.

Source: The White House (executive order), White House (Fact Sheet on Executive Order), US Department of Health and Human Services (fact sheet on HHS implementation of executive order)