[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Presidential Documents]
[Pages 56849-56860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20167]



[[Page 56847]]

Vol. 87

Thursday,

No. 178

September 15, 2022

Part III





The President





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Executive Order 14081--Advancing Biotechnology and Biomanufacturing 
Innovation for a Sustainable, Safe, and Secure American Bioeconomy
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  Federal Register / Vol. 87 , No. 178 / Thursday, September 15, 2022 / 
Presidential Documents  

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 Title 3--
 The President

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                Executive Order 14081 of September 12, 2022

                
Advancing Biotechnology and Biomanufacturing 
                Innovation for a Sustainable, Safe, and Secure American 
                Bioeconomy

                By the authority vested in me as President by the 
                Constitution and the laws of the United States of 
                America, it is hereby ordered as follows:

                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.

                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. 
                The economic activity derived from biotechnology and 
                biomanufacturing is referred to as ``the bioeconomy.'' 
                The COVID-19 pandemic has demonstrated the vital role 
                of biotechnology and biomanufacturing in developing and 
                producing life-saving diagnostics, therapeutics, and 
                vaccines that protect Americans and the world. 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.

                For 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.

                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

[[Page 56850]]

                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.

                To achieve these objectives, it is the policy of my 
                Administration to:

                    (a) bolster and coordinate Federal investment in 
                key research and development (R&D) areas of 
                biotechnology and biomanufacturing in order to further 
                societal goals;
                    (b) foster a biological data ecosystem that 
                advances biotechnology and biomanufacturing innovation, 
                while adhering to principles of security, privacy, and 
                responsible conduct of research;
                    (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;
                    (d) boost sustainable biomass production and create 
                climate-smart incentives for American agricultural 
                producers and forest landowners;
                    (e) expand market opportunities for bioenergy and 
                biobased products and services;
                    (f) train and support a diverse, skilled workforce 
                and a next generation of leaders from diverse groups to 
                advance biotechnology and biomanufacturing;
                    (g) clarify and streamline regulations in service 
                of a science- and risk-based, predictable, efficient, 
                and transparent system to support the safe use of 
                products of biotechnology;
                    (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;
                    (i) promote standards, establish metrics, and 
                develop systems to grow and assess the state of the 
                bioeconomy; to better inform policy, decision-making, 
                and investments in the bioeconomy; and to ensure 
                equitable and ethical development of the bioeconomy;
                    (j) secure and protect the United States bioeconomy 
                by adopting a forward-looking, 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 relevant stakeholders to jointly mitigate 
                risks to protect technology leadership and economic 
                competitiveness; and
                    (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.

                The efforts undertaken pursuant to this order to 
                further these policies shall be referred to 
                collectively as the National Biotechnology and 
                Biomanufacturing Initiative.

                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.

[[Page 56851]]

                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.

(v) The Director of the National Science Foundation (NSF), in consultation 
with the heads of appropriate agencies as determined by the Director, shall 
submit a report identifying high-priority fundamental and use-inspired 
basic research goals to advance biotechnology and biomanufacturing and to 
address the societal goals identified in this section.

                    (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

[[Page 56852]]

                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.
                    (h) Within 180 days of the date of this order, the 
                President's Council of Advisors on Science and 
                Technology shall submit to the President and make 
                publicly available a report on the bioeconomy that 
                provides recommendations on how to maintain United 
                States competitiveness in the global bioeconomy.

                Sec. 4. Data for the Bioeconomy. (a) In order to 
                facilitate development of the United States bioeconomy, 
                my Administration shall establish a Data for the 
                Bioeconomy Initiative (Data Initiative) that will 
                ensure that high-quality, wide-ranging, easily 
                accessible, and secure biological data sets can drive 
                breakthroughs for the United States bioeconomy. To 
                assist in the development of the Data Initiative, the 
                Director of OSTP, in coordination with the Director of 
                OMB and the heads of appropriate agencies as determined 
                by the Director of OSTP, and in consultation with 
                external stakeholders, shall issue a report within 240 
                days of the date of this order that:

(i) 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;

(ii) sets forth a plan to fill any 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;

(iii) identifies--based on the data types and sources described in 
subsection (a)(i) of this section--security, privacy, and other risks (such 
as malicious misuses, manipulation, exfiltration, and deletion), and 
provides a data-protection plan to mitigate these risks; and

(iv) outlines the Federal resources, legal authorities, and actions needed 
to support the Data Initiative and achieve the goals outlined in this 
subsection, with a timeline for action.

                    (b) The Secretary of Homeland Security, in 
                coordination with the Secretary of Defense, the 
                Secretary of Agriculture, the Secretary of Commerce 
                (acting through the Director of the National Institute 
                of Standards and Technology (NIST)), the Secretary of 
                HHS, the Secretary of Energy, and the Director of OMB, 
                shall identify and recommend relevant cybersecurity 
                best practices for biological data stored on Federal 
                Government information systems, consistent with 
                applicable law and Executive Order 14028 of May 12, 
                2021 (Improving the Nation's Cybersecurity).

[[Page 56853]]

                    (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.

                Sec. 5. Building a Vibrant Domestic Biomanufacturing 
                Ecosystem. (a) Within 180 days of the date of this 
                order, the APNSA and the APEP, in coordination with the 
                Secretary of Defense, the Secretary of Agriculture, the 
                Secretary of Commerce, the Secretary of HHS, the 
                Secretary of Energy, the Director of NSF, and the 
                Administrator of the National Aeronautics and Space 
                Administration (NASA), shall 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. Additionally, this strategy shall 
                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.

                    (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:

(i) the NSF shall expand its existing Regional Innovation Engine program to 
advance emerging technologies, including biotechnology;

(ii) the Department of Commerce shall address challenges in 
biomanufacturing supply chains and related biotechnology development 
infrastructure;

(iii) the Department of Defense shall incentivize the expansion of 
domestic, flexible industrial biomanufacturing capacity for a wide range of 
materials that can be used to make a diversity of products for the defense 
supply chain; and

(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.

                    (c) Within 1 year of the date of this order, the 
                Secretary of Agriculture, in consultation with the 
                heads of appropriate agencies as determined by the 
                Secretary, shall submit a plan to the President, 
                through the APNSA and the APEP, to support the 
                resilience of the United States biomass supply chain 
                for domestic biomanufacturing and biobased product 
                manufacturing, while also advancing food security, 
                environmental sustainability, and the needs of 
                underserved communities. This plan shall include 
                programs to encourage climate-smart production and use 
                of domestic biomass, along with budget estimates, 
                including accounting for funds appropriated for Fiscal 
                Year (FY) 2022 and proposed in the President's FY 2023 
                Budget.
                    (d) Within 180 days of the date of this order, the 
                Secretary of Homeland Security, in coordination with 
                the heads of appropriate agencies as determined by the 
                Secretary, shall:

(i) provide the APNSA with vulnerability assessments of the critical 
infrastructure and national critical functions associated with the 
bioeconomy, including cyber, physical, and systemic risks, and 
recommendations to secure and make resilient these components of our 
infrastructure and economy; and

(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

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coordination shall be informed in part by the assessments described in 
subsection (d)(i) of this section.

                Sec. 6. Biobased Products Procurement. (a) Consistent 
                with the requirements of 7 U.S.C. 8102, within 1 year 
                of the date of this order, procuring agencies as 
                defined in 7 U.S.C. 8102(a)(1)(A) that have not yet 
                established a biobased procurement program as described 
                in 7 U.S.C. 8102(a)(2) shall establish such a program.

                    (b) Procuring agencies shall require that, within 2 
                years of the date of this order, all appropriate staff 
                (including contracting officers, purchase card 
                managers, and purchase card holders) complete training 
                on biobased product purchasing. The Office of Federal 
                Procurement Policy, within OMB, in cooperation with the 
                Secretary of Agriculture, shall provide training 
                materials for procuring agencies.
                    (c) Within 180 days of the date of this order and 
                annually thereafter, procuring agencies shall report 
                previous fiscal year spending to the Director of OMB on 
                the following:

(i) the number and dollar value of contracts entered into during the 
previous fiscal year that include the direct procurement of biobased 
products;

(ii) the number of service and construction (including renovations) 
contracts entered into during the previous fiscal year that include 
language on the use of biobased products; and

(iii) the types and dollar values of biobased products actually used by 
contractors in carrying out service and construction (including 
renovations) contracts during the previous fiscal year.

                    (d) The requirements in subsection (c) of this 
                section shall not apply to purchase card transactions 
                and other ``[a]ctions not reported'' to the Federal 
                Procurement Data System pursuant to 48 CFR 4.606(c).
                    (e) Within 1 year of the date of this order and 
                annually thereafter, the Director of OMB shall publish 
                information on biobased procurement resulting from the 
                data collected under subsection (c) of this section and 
                information reported under 7 U.S.C. 8102, along with 
                other related information, and shall use scorecards or 
                similar systems to encourage increased biobased 
                purchasing.
                    (f) Within 1 year of the date of this order and 
                annually thereafter, procuring agencies shall report to 
                the Secretary of Agriculture specific categories of 
                biobased products that are unavailable to meet their 
                procurement needs, along with desired performance 
                standards for currently unavailable products and other 
                relevant specifications. The Secretary of Agriculture 
                shall publish this information annually. When new 
                categories of biobased products become commercially 
                available, the Secretary of Agriculture shall designate 
                new product categories for preferred Federal 
                procurement, as prescribed by 7 U.S.C. 8102.
                    (g) Procuring agencies shall strive to increase by 
                2025 the amount of biobased product obligations or the 
                number or dollar value of biobased-only contracts, as 
                reflected in the information described in subsection 
                (c) of this section, and as appropriate and consistent 
                with applicable law.

                Sec. 7. Biotechnology and Biomanufacturing Workforce. 
                (a) The United States Government shall expand training 
                and education opportunities for all Americans in 
                biotechnology and biomanufacturing. To support this 
                objective, within 200 days of the date of this order, 
                the Secretary of Commerce, the Secretary of Labor, the 
                Secretary of Education, the APDP, the Director of OSTP, 
                and the Director of NSF shall produce and make publicly 
                available a plan to coordinate and use relevant Federal 
                education and training programs, while also 
                recommending new efforts to promote multi-disciplinary 
                education programs. This plan shall promote the 
                implementation of 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

[[Page 56855]]

                and biomanufacturing. This plan shall also include a 
                focused discussion of Historically Black Colleges and 
                Universities, Tribal Colleges and Universities, and 
                Minority Serving Institutions and the extent to which 
                agencies can use existing statutory authorities to 
                promote racial and gender equity and support 
                underserved communities, consistent with the policy 
                established in Executive Order 13985. Finally, this 
                plan shall account for funds appropriated for FY 2022 
                and proposed in the President's FY 2023 Budget.

                    (b) Within 2 years of the date of this order, 
                agencies that support relevant Federal education and 
                training programs as described in subsection (a) of 
                this section shall report to the President through the 
                APNSA, in coordination with the Director of OMB, the 
                ADPD, and the Director of OSTP, on measures taken and 
                resources allocated to enhance workforce development 
                pursuant to the plan described in subsection (a) of 
                this section.

                Sec. 8. Biotechnology Regulation Clarity and 
                Efficiency. Advances in biotechnology are rapidly 
                altering the product landscape. The complexity of the 
                current regulatory system for biotechnology products 
                can be confusing and create challenges for businesses 
                to navigate. To improve the clarity and efficiency of 
                the regulatory process for biotechnology products, and 
                to enable products that further the societal goals 
                identified in section 3 of this order, the Secretary of 
                Agriculture, the Administrator of the Environmental 
                Protection Agency, and the Commissioner of Food and 
                Drugs, in coordination with the Director of OMB, the 
                ADPD, and the Director of OSTP, shall:

                    (a) within 180 days of the date of this order, 
                identify areas of ambiguity, gaps, or uncertainties in 
                the January 2017 Update to the Coordinated Framework 
                for the Regulation of Biotechnology or in the policy 
                changes made pursuant to Executive Order 13874 of June 
                11, 2019 (Modernizing the Regulatory Framework for 
                Agricultural Biotechnology Products), including by 
                engaging with developers and external stakeholders, and 
                through horizon scanning for novel products of 
                biotechnology;
                    (b) within 100 days of completing the task in 
                subsection (a) of this section, 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;
                    (c) within 280 days of the date of this order, 
                provide a plan to the Director of OMB, the ADPD, and 
                the Director of OSTP with 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;
                    (d) within 1 year of the date of this order, build 
                on the Unified website for Biotechnology Regulation 
                developed pursuant to Executive Order 13874 by 
                including on the website the information developed 
                under subsection (b) of this section, and by enabling 
                developers of biotechnology products to submit 
                inquiries about a particular product and promptly 
                receive a single, coordinated response that provides, 
                to the extent practicable, information and, when 
                appropriate, informal guidance regarding the process 
                that the developers must follow for Federal regulatory 
                review; and
                    (e) within 1 year of the date of this order, and 
                annually thereafter for a period of 3 years, provide an 
                update regarding progress in implementing this section 
                to the Director of OMB, the United States Trade 
                Representative (USTR), the APNSA, the ADPD, and the 
                Director of OSTP. Each 1-year update shall identify any 
                gaps in statutory authority that should be addressed to 
                improve the clarity and efficiency of the regulatory 
                process for biotechnology products, and shall recommend 
                additional executive actions and legislative proposals 
                to achieve such goals.

                Sec. 9. Reducing Risk by Advancing Biosafety and 
                Biosecurity. (a) The United States Government shall 
                launch a Biosafety and Biosecurity Innovation 
                Initiative, which shall seek to reduce biological risks 
                associated with

[[Page 56856]]

                advances in biotechnology, biomanufacturing, and the 
                bioeconomy. Through the Biosafety and Biosecurity 
                Innovation Initiative--which shall be established by 
                the Secretary of HHS, in coordination with the heads of 
                other relevant agencies as determined by the 
                Secretary--agencies that fund, conduct, or sponsor life 
                sciences research shall implement the following 
                actions, as appropriate and consistent with applicable 
                law:

(i) support, as a priority, investments in applied biosafety research and 
innovations in biosecurity to reduce biological risk throughout the 
biotechnology R&D and biomanufacturing lifecycles; and

(ii) use Federal investments in biotechnology and biomanufacturing to 
incentivize and enhance biosafety and biosecurity practices and best 
practices throughout the United States and international research 
enterprises.

                    (b) Within 180 days of the date of this order, the 
                Secretary of HHS and the Secretary of Homeland 
                Security, in coordination with agencies that fund, 
                conduct, or sponsor life sciences research, shall 
                produce a plan for biosafety and biosecurity for the 
                bioeconomy, including recommendations to:

(i) enhance applied biosafety research and bolster innovations in 
biosecurity to reduce risk throughout the biotechnology R&D and 
biomanufacturing lifecycles; and

(ii) use Federal investments in biological sciences, biotechnology, and 
biomanufacturing to enhance biosafety and biosecurity best practices 
throughout the bioeconomy R&D enterprise.

                    (c) Within 1 year of the date of this order, 
                agencies that fund, conduct, or sponsor life sciences 
                research shall report to the APNSA, through the 
                Assistant to the President and Homeland Security 
                Advisor, on efforts to achieve the objectives described 
                in subsection (a) of this section.

                Sec. 10. Measuring the Bioeconomy. (a) Within 90 days 
                of the date of this order, the Secretary of Commerce, 
                through the Director of NIST, shall, in consultation 
                with other agencies as determined by the Director, 
                industry, and other stakeholders, as appropriate, 
                create and make publicly available a lexicon for the 
                bioeconomy, with consideration of relevant domestic and 
                international definitions and 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.

                    (b) The Chief Statistician of the United States, in 
                coordination with the Secretary of Agriculture, the 
                Secretary of Commerce, the Director of NSF, and the 
                heads of other appropriate agencies as determined by 
                the Chief Statistician, shall improve and enhance 
                Federal statistical data collection designed to 
                characterize the economic value of the United States 
                bioeconomy, with a focus on the contribution of 
                biotechnology to the bioeconomy. This effort shall 
                include:

(i) within 180 days of the date of this order, assessing, through the 
Department of Commerce's Bureau of Economic Analysis, the feasibility, 
scope, and costs of developing a national measurement of the economic 
contributions of the bioeconomy, and, in particular, the contributions of 
biotechnology to the bioeconomy, including recommendations and a plan for 
next steps regarding whether development of such a measurement should be 
pursued; and

(ii) within 120 days of the date of this order, establishing an Interagency 
Technical Working Group (ITWG), chaired by the Chief Statistician of the 
United States, which shall include representatives of the Department of 
Agriculture, the Department of Commerce, OSTP, the NSF, and other 
appropriate agencies as determined by the Chief Statistician of the United 
States.

  (A) Within 1 year of the date of this order, the ITWG shall recommend 
bioeconomy-related revisions to the North American Industry Classification 
System (NAICS) and the North American Product Classification System

[[Page 56857]]

(NAPCS) to the Economic Classification Policy Committee. In 2026, the ITWG 
shall initiate a review process of the 2023 recommendations and update the 
recommendations, as appropriate, to provide input to the 2027 NAICS and 
NAPCS revision processes.

  (B) Within 18 months of the date of this order, the ITWG shall provide a 
report to the Chief Statistician of the United States describing the 
Federal statistical collections of information that take advantage of 
bioeconomy-related NAICS and NAPCS codes, and shall include recommendations 
to implement any bioeconomy-related changes as part of the 2022 revisions 
of the NAICS and NAPCS. As part of its work, the ITWG shall consult with 
external stakeholders.

                Sec. 11. Assessing Threats to the United States 
                Bioeconomy. (a) The Director of National Intelligence 
                (DNI) shall lead a comprehensive interagency 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. 
                As part of this effort, the DNI shall work closely with 
                the Department of Defense to assess technical 
                applications of biotechnology and biomanufacturing that 
                could be misused by a foreign adversary for military 
                purposes or that could otherwise pose a risk to the 
                United States. In support of these objectives, the DNI 
                shall identify elements of the bioeconomy of highest 
                concern and establish processes to support ongoing 
                threat identification and impact assessments.

                    (b) Within 240 days of the date of this order, the 
                DNI shall provide classified assessments to the APNSA 
                related to:

(i) threats to United States national and economic security posed by 
foreign adversary development and application of biomanufacturing; and

(ii) foreign adversary means of, and intended usages related to, 
acquisition of United States biotechnologies, biological data, and 
proprietary or precompetitive information.

                    (c) Within 120 days of receiving the DNI's 
                assessments, the APNSA shall coordinate with the heads 
                of relevant agencies as determined through the NSM-2 
                process to develop and finalize a plan to mitigate 
                risks to the United States bioeconomy, based upon the 
                threat identification and impact assessments described 
                in subsection (a) of this section, the vulnerability 
                assessments described in section 5(d) of this order, 
                and other relevant assessments or information. The plan 
                shall identify where executive action, regulatory 
                action, technology protection, or statutory authorities 
                are needed to mitigate these risks in order to support 
                the technology leadership and economic competitiveness 
                of the United States bioeconomy.
                    (d) The United States Government contracts with a 
                variety of providers to support its functioning, 
                including by contracting for services related to the 
                bioeconomy. It is important that these contracts are 
                awarded according to full and open competition, as 
                consistent with the Competition in Contracting Act of 
                1984 (Public Law 98-369, 98 Stat. 1175). In accordance 
                with these objectives, and within 1 year of the date of 
                this order, the Director of OSTP, in coordination with 
                the Secretary of Defense, the Attorney General, the 
                Secretary of HHS, the Secretary of Energy, the 
                Secretary of Homeland Security, the DNI, the 
                Administrator of NASA, and the Administrator of General 
                Services, shall review the national security 
                implications of existing requirements related to 
                Federal procurement--including requirements contained 
                in the Federal Acquisition Regulation (FAR) and the 
                Defense Federal Acquisition Regulation Supplement--and 
                shall recommend updates to those requirements to the 
                FAR Council, the Director of OMB, and the heads of 
                other appropriate agencies as determined through the 
                NSM-2 process. The recommendations shall aim to 
                standardize pre-award data collection to enable due 
                diligence review of conflict of interest; conflict of 
                commitment; foreign ownership, control, or influence; 
                or other potential national security

[[Page 56858]]

                concerns. The recommendations shall also include 
                legislative proposals, as relevant.
                    (e) The Director of OMB shall issue a management 
                memorandum to agencies, or take other appropriate 
                action, to provide generalized guidance based on the 
                recommendations received pursuant to subsection (d) of 
                this section.

                Sec. 12. International Engagement. (a) The Department 
                of State and other agencies that engage with 
                international partners as part of their missions shall 
                undertake the following actions with foreign partners, 
                as appropriate and consistent with applicable law--with 
                a specific focus on developing countries, international 
                organizations, and nongovernmental entities--to promote 
                and protect both the United States and global 
                bioeconomies:

(i) enhance cooperation, including joint research projects and expert 
exchanges, on biotechnology R&D, especially in genomics;

(ii) encourage regulatory cooperation and the adoption of best practices to 
evaluate and promote innovative products, with an emphasis on those 
practices and products that support sustainability and climate objectives;

(iii) develop joint training arrangements and initiatives to support 
bioeconomy jobs in the United States;

(iv) work to promote the open sharing of scientific data, including genetic 
sequence data, to the greatest extent possible in accordance with 
applicable law and policy, while seeking to ensure that any applicable 
access and benefit-sharing mechanisms do not hinder the rapid and 
sustainable development of innovative products and biotechnologies;

(v) conduct horizon scanning to anticipate threats to the global 
bioeconomy, including national security threats from foreign adversaries 
acquiring sensitive technologies or data, or disrupting essential bio-
related supply chains, and to identify opportunities to address those 
threats;

(vi) engage allies and partners to address shared national security 
threats;

(vii) develop, and work to promote and implement, biosafety and biosecurity 
best practices, tools, and resources bilaterally and multilaterally to 
facilitate appropriate oversight for life sciences, dual-use research of 
concern, and research involving potentially pandemic and other high-
consequence pathogens, and to enhance sound risk management of 
biotechnology- and biomanufacturing-related R&D globally; and

(viii) explore how to align international classifications of 
biomanufactured products, as appropriate, to measure the value of those 
products to both the United States and global bioeconomies.

                    (b) Within 180 days of the date of this order, the 
                Secretary of State, in coordination with the USTR and 
                the heads of other agencies as determined by the 
                Secretary, as appropriate, shall submit to the APNSA a 
                plan to support the objectives described in subsection 
                (a) of this section with foreign partners, 
                international organizations, and nongovernmental 
                entities.

                Sec. 13. Definitions. For purposes of this order:

                    (a) The term ``agency'' has the meaning given that 
                term by 44 U.S.C. 3502(1).
                    (b) The term ``biotechnology'' means technology 
                that applies to or is enabled by life sciences 
                innovation or product development.
                    (c) The term ``biomanufacturing'' means the use of 
                biological systems to develop products, tools, and 
                processes at commercial scale.
                    (d) The term ``bioeconomy'' means economic activity 
                derived from the life sciences, particularly in the 
                areas of biotechnology and biomanufacturing, and 
                includes industries, products, services, and the 
                workforce.
                    (e) The term ``biological data'' means the 
                information, including associated descriptors, derived 
                from the structure, function, or process of a 
                biological system(s) that is measured, collected, or 
                aggregated for analysis.

[[Page 56859]]

                    (f) The term ``biomass'' means any material of 
                biological origin that is available on a renewable or 
                recurring basis. Examples of biomass include plants, 
                trees, algae, and waste material such as crop residue, 
                wood waste, animal waste and byproducts, food waste, 
                and yard waste.
                    (g) The term ``biobased product'' has the meaning 
                given that term in 7 U.S.C. 8101(4).
                    (h) The term ``bioenergy'' means energy derived in 
                whole or in significant part from biomass.
                    (i) The term ``multiomic information'' refers to 
                combined information derived from data, analysis, and 
                interpretation of multiple omics measurement 
                technologies to identify or analyze the roles, 
                relationships, and functions of biomolecules (including 
                nucleic acids, proteins, and metabolites) that make up 
                a cell or cellular system. Omics are disciplines in 
                biology that include genomics, transcriptomics, 
                proteomics, and metabolomics.
                    (j) The term ``key R&D areas'' includes fundamental 
                R&D of emerging biotechnologies, including engineering 
                biology; predictive engineering of complex biological 
                systems, including the designing, building, testing, 
                and modeling of entire living cells, cell components, 
                or cellular systems; quantitative and theory-driven 
                multi-disciplinary research to maximize convergence 
                with other enabling technologies; and regulatory 
                science, including the development of new information, 
                criteria, tools, models, and approaches to inform and 
                assist regulatory decision-making. These R&D priorities 
                should be coupled with advances in predictive modeling, 
                data analytics, artificial intelligence, 
                bioinformatics, high-performance and other advanced 
                computing systems, metrology and data-driven standards, 
                and other non-life science enabling technologies.
                    (k) The terms ``equity'' and ``underserved 
                communities'' have the meanings given those terms by 
                sections 2(a) and 2(b) of Executive Order 13985.
                    (l) The term ``Tribal Colleges and Universities'' 
                has the meaning given that term by section 5(e) of 
                Executive Order 14049 of October 11, 2021 (White House 
                Initiative on Advancing Educational Equity, Excellence, 
                and Economic Opportunity for Native Americans and 
                Strengthening Tribal Colleges and Universities).
                    (m) The term ``Historically Black Colleges and 
                Universities'' has the meaning given that term by 
                section 4(b) of Executive Order 14041 of September 3, 
                2021 (White House Initiative on Advancing Educational 
                Equity, Excellence, and Economic Opportunity Through 
                Historically Black Colleges and Universities).
                    (n) The term ``minority serving institution'' has 
                the meaning given that term by 38 U.S.C. 3698(f)(4).
                    (o) The term ``foreign adversary'' has the meaning 
                given that term by section 3(b) of Executive Order 
                14034 of June 9, 2021 (Protecting Americans' Sensitive 
                Data From Foreign Adversaries).
                    (p) The term ``life sciences'' means all sciences 
                that study or use living organisms, viruses, or their 
                products, including all disciplines of biology and all 
                applications of the biological sciences (including 
                biotechnology, genomics, proteomics, bioinformatics, 
                and pharmaceutical and biomedical research and 
                techniques), but excluding scientific studies 
                associated with radioactive materials or toxic 
                chemicals that are not of biological origin or 
                synthetic analogues of toxins.

                Sec. 14. General Provisions. (a) Nothing in this order 
                shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or 
the head thereof; or

(ii) the functions of the Director of OMB relating to budgetary, 
administrative, or legislative proposals.

[[Page 56860]]

                    (b) This order shall be implemented consistent with 
                applicable law and subject to the availability of 
                appropriations.
                    (c) This order is not intended to, and does not, 
                create any right or benefit, substantive or procedural, 
                enforceable at law or in equity by any party against 
                the United States, its departments, agencies, or 
                entities, its officers, employees, or agents, or any 
                other person.
                
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    September 12, 2022.

[FR Doc. 2022-20167
Filed 9-14-22; 11:15 am]
Billing code 3395-F2-P