Section 1. Policy. It is the policy of my Administration to coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security. Central to this policy and its outcomes are principles of equity, ethics, safety, and security that enable access to technologies, processes, and products in a manner that benefits all Americans and the global community and that maintains United States technological leadership and economic competitiveness.
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Simultaneously, we must take concrete steps to reduce biological risks associated with advances in biotechnology. We need to invest in and promote biosafety and biosecurity to ensure that biotechnology is developed and deployed in ways that align with United States principles and values and international best practices, and not in ways that lead to accidental or deliberate harm to people, animals, or the environment. In addition, we must safeguard the United States bioeconomy, as foreign adversaries and strategic competitors alike use legal and illegal means to acquire United States technologies and data, including biological data, and proprietary or precompetitive information, which threatens United States economic competitiveness and national security.
We also must ensure that uses of biotechnology and biomanufacturing are ethical and responsible; are centered on a foundation of equity and public good, consistent with Executive Order 13985 of January 20, 2021 (Advancing Racial Equity and Support for Underserved Communities Through the Federal Government); and are consistent with respect for human rights. Resources should be invested justly and equitably so that biotechnology and biomanufacturing technologies benefit all Americans, especially those in underserved communities, as well as the broader global community.
(c) 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;
(h) elevate biological risk management as a cornerstone of the life cycle of biotechnology and biomanufacturing R&D, including by providing for research and investment in applied biosafety and biosecurity innovation;
(k) engage the international community to enhance biotechnology R&D cooperation in a way that is consistent with United States principles and values and that promotes best practices for safe and secure biotechnology and biomanufacturing research, innovation, and product development and use.
Sec. 2. Coordination. 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), shall coordinate the executive branch actions necessary to implement this order through the interagency process described in National Security Memorandum 2 of February 4, 2021 (Renewing the National Security Council System) (NSM-2 process). In implementing this order, heads of agencies (as defined in section 13 of this order) shall, as appropriate and consistent with applicable law, consult outside stakeholders, such as those in industry; academia; nongovernmental organizations; communities; labor unions; and State, local, Tribal, and territorial governments to advance the policies described in section 1 of this order.
Sec. 3. Harnessing Biotechnology and Biomanufacturing R&D to Further Societal Goals. (a) Within 180 days of the date of this order, the heads of agencies specified in subsections (a)(i)-(v) of this section shall submit the following 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. The reports shall be submitted to the President through the APNSA, in coordination with the Director of the Office of Management and Budget (OMB), the APEP, the Assistant to the President for Domestic Policy (APDP), and the Director of OSTP.
(i) The Secretary of Health and Human Services (HHS), in consultation with the heads of appropriate agencies as determined by the Secretary, shall submit a report assessing how to use biotechnology and biomanufacturing to achieve medical breakthroughs, reduce the overall burden of disease, and improve health outcomes.
(ii) The Secretary of Energy, in consultation with the heads of appropriate agencies as determined by the Secretary, shall submit a report assessing 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.
(iii) The Secretary of Agriculture, in consultation with the heads of appropriate agencies as determined by the Secretary, shall submit a report 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.
(iv) The Secretary of Commerce, in consultation with the Secretary of Defense, the Secretary of HHS, and the heads of other appropriate agencies as determined by the Secretary of Commerce, shall submit a report assessing how to use biotechnology and biomanufacturing to strengthen the resilience of United States supply chains.
(b) Each report specified in subsection (a) of this section shall identify high-priority basic research and technology development needs to achieve the overall objectives described in subsection (a) of this section, as well as opportunities for public-private collaboration. Each of these reports shall also include recommendations for actions to enhance biosafety and biosecurity to reduce risk throughout the biotechnology R&D and biomanufacturing lifecycles.
(c) Within 100 days of receiving the reports required under subsection (a) of this section, the Director of OSTP, in coordination with the Director of OMB, the APNSA, the APEP, the APDP, and the heads of appropriate agencies as determined through the NSM-2 process, shall develop a plan (implementation plan) to implement the recommendations in the reports. The development of this implementation plan shall also include the solicitation of input from external experts regarding potential ethical implications or other societal impacts, including environmental sustainability and environmental justice, of the recommendations contained in the reports required under subsection (a) of this section. The implementation plan shall include assessments and make recommendations regarding any such implications or impacts.
(d) Within 90 days of the date of this order, the Director of OMB, in consultation with the heads of appropriate agencies as determined through the NSM-2 process, shall perform a budget crosscut to identify existing levels of agency spending on biotechnology- and biomanufacturing-related activities to inform the development of the implementation plan described in subsection (c) of this section.
(e) The APNSA, in coordination with the Director of OMB, the APEP, the APDP, and the Director of OSTP, shall review the reports required under subsection (a) of this section and shall submit the reports to the President in an unclassified form, but may include a classified annex.
(f) The APNSA, in coordination with the Director of OMB, the APEP, the APDP, and the Director of OSTP, shall include a cover memorandum for the reports submitted pursuant to subsection (a) of this section, along with the implementation plan required under subsection (c) of this section, in which they make any additional overall recommendations for advancing biotechnology and biomanufacturing.
(g) Within 2 years of the date of this order, agencies at which recommendations are directed in the implementation plan required under subsection (c) of this section shall report to the Director of OMB, the APNSA, the APEP, the APDP, and the Director of OSTP on measures taken and resources allocated to enhance biotechnology and biomanufacturing, consistent with the implementation plan described in subsection (c) of this section.
(c) The Secretary of Commerce, acting through the Director of NIST and in coordination with the Secretary of HHS, shall 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 United States Government, consistent with section 4 of Executive Order 14028.
(b) Agencies identified in subsections (b)(i)-(iv) of this section shall direct resources, as appropriate and consistent with applicable law, towards the creation or expansion of programs that support a vibrant domestic biomanufacturing ecosystem, as informed by the strategy developed pursuant to subsection (a) of this section:
(iv) the Department of Energy shall support research to accelerate bioenergy and bioproduct science advances, to accelerate biotechnology and bioinformatics tool development, and to reduce the hurdles to commercialization, including through incentivizing the engineering scale-up of promising biotechnologies and the expansion of biomanufacturing capacity.
(ii) enhance coordination with industry on threat information sharing, vulnerability disclosure, and risk mitigation for cybersecurity and infrastructure risks to the United States bioeconomy, including risks to biological data and related physical and digital infrastructure and devices. This coordination shall be informed in part by the assessments described in subsection (d)(i) of this section. 2ff7e9595c
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