42 U.S.C. § 19131 — Definitions

Page 9312 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 19118 (c) Emerging technologies After completion of the studies regarding emerging technologies conducted by the Sec- retary of Commerce under title XV of division FF of the Consolidated Appropriations Act, 2021 (Public Law 116–260), the Director shall consider the results of such studies in carrying out the activities of the Directorate. (Pub. L. 117–167, div. B, title III, § 10397, Aug. 9, 2022, 136 Stat. 1597.) Editorial Notes REFERENCES IN TEXT This division, referred to in subsec. (b), is div. B of Pub. L. 117–167, Aug. 9, 2022, 136 Stat. 1399, which en- acted this chapter and enacted, amended, and repealed numerous other sections and notes in the Code. For complete classification of div. B to the Code, see Short Title note set out under section 18901 of this title and Tables. Title XV of division FF of the Consolidated Appro- priations Act, 2021, referred to in subsec. (c), is title XV of Pub. L. 116–260, div. FF, Dec. 27, 2020, 134 Stat. 3276, known as the American Competitiveness Of a More Productive Emerging Tech Economy Act, and also known as the American COMPETE Act, which is not classified to the Code. § 19118. Ethical, legal, and societal consider- ations The Director shall engage, as appropriate, ex- perts in the social dimensions of science and technology and set up formal avenues for public input, as appropriate, to ensure that ethical, legal, and societal considerations are taken into account in the priorities and activities of the Directorate, including in the selection of the challenges and key technology focus areas under section 19107 of this title and the award-making process, and throughout all stages of supported projects. (Pub. L. 117–167, div. B, title III, § 10398, Aug. 9, 2022, 136 Stat. 1597.) § 19119. Reports and roadmaps (a) Annual report The Director shall provide to the relevant au- thorizing and appropriations committees of Con- gress an annual report describing projects sup- ported by the Directorate during the previous year. (b) Roadmap Not later than 1 year after August 9, 2022, the Director shall provide to the relevant author- izing and appropriations committees of Congress a roadmap describing the strategic vision that the Directorate will use to guide investment de- cisions over the following 3 years. (c) Reports Not later than 1 year after August 9, 2022, and every 3 years thereafter, the Director, in con- sultation with the heads of relevant Federal agencies, shall prepare and submit to Congress— (1) a strategic vision for the next 5 years for the Directorate, including a description of how the Foundation will increase funding for re- search and education for populations under- represented in STEM and geographic areas; and (2) a description of the planned activities of the Directorate to secure federally funded science and technology pursuant to section 1746 of the National Defense Authorization Act for Fiscal Year 2020 (Public Law 116–92; 42 U.S.C. 6601 note) and section 6605 of this title and the requirements under part D of this sub- chapter and subtitle E of title VI. (d) Selection criteria report Not later than 24 months after the establish- ment of the Directorate, the Director shall pre- pare and submit a report to Congress regarding the use of alternative methods for the selection of award recipients and the distribution of fund- ing to recipients, as compared to the traditional peer review process. (Pub. L. 117–167, div. B, title III, § 10399, Aug. 9, 2022, 136 Stat. 1598.) Editorial Notes REFERENCES IN TEXT Subtitle E of title VI, referred to in subsec. (c)(2), is subtitle E (§§ 10641–10649) of title VI of div. B of Pub. L. 117–167, Aug. 9, 2022, 136 Stat. 1672, known as the Coastal and Ocean Acidification Research and Innovation Act of 2021. For complete classification of subtitle E to the Code, see Short Title of 2022 Amendment note set out under section 3701 of Title 33, Navigation and Navigable Waters, and Tables. § 19120. Evaluation (a) In general After the Directorate has been in operation for 6 years, the Director shall enter into an agree- ment with the National Academies to provide an evaluation of how well the Directorate is achiev- ing the purposes identified in section 19102 of this title. (b) Inclusions The evaluation shall include— (1) an assessment of the impact of Direc- torate activities on the Foundation’s primary science mission; (2) an assessment of the Directorate’s im- pact on the challenges and key technology focus areas under section 19107 of this title; (3) an assessment of efforts to ensure coordi- nation between the Directorate and other Fed- eral agencies, and with external entities; (4) a description of lessons learned from op- eration of the Directorate; and (5) recommended funding levels for the Di- rectorate; (c) Availability On completion of the evaluation, the evalua- tion shall be made available to Congress and the public. (Pub. L. 117–167, div. B, title III, § 10399A, Aug. 9, 2022, 136 Stat. 1598.) SUBCHAPTER IV—BIOECONOMY RESEARCH AND DEVELOPMENT § 19131. Definitions In this subchapter: (1) Initiative The term ‘‘Initiative’’ means the National Engineering Biology Research and Develop- Page 9313 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 19131 ment Initiative established under section 19132 of this title. (2) Omics The term ‘‘omics’’ refers to the collective technologies used to explore the roles, rela- tionships, and actions of the various types of molecules that make up the cells and systems of an organism and the systems level analysis of their functions. (Pub. L. 117–167, div. B, title IV, § 10401, Aug. 9, 2022, 136 Stat. 1599.) Executive Documents EX. ORD. NO. 14081. ADVANCING BIOTECHNOLOGY AND BIO- MANUFACTURING INNOVATION FOR A SUSTAINABLE, SAFE, AND SECURE AMERICAN BIOECONOMY Ex. Ord. No. 14081, Sept. 12, 2022, 87 F.R. 56849, pro- vided: 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 Administra- tion 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, safe- ty, and security that enable access to technologies, processes, and products in a manner that benefits all Americans and the global community and that main- tains United States technological leadership and eco- nomic competitiveness. Biotechnology harnesses the power of biology to cre- ate new services and products, which provide opportu- nities to grow the United States economy and work- force and improve the quality of our lives and the envi- ronment. The economic activity derived from bio- technology and biomanufacturing is referred to as ‘‘the bioeconomy.’’ The COVID–19 pandemic has dem- onstrated the vital role of biotechnology and biomanu- facturing 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 con- text of human health, biotechnology and biomanufac- turing can also be used to achieve our climate and en- ergy 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 tech- niques to be able to write circuitry for cells and pre- dictably 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 ob- stacles for commercialization so that innovative tech- nologies and products can reach markets faster. Simultaneously, we must take concrete steps to re- duce biological risks associated with advances in bio- technology. We need to invest in and promote biosafety and biosecurity to ensure that biotechnology is devel- oped 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 de- liberate harm to people, animals, or the environment. In addition, we must safeguard the United States bio- economy, as foreign adversaries and strategic competi- tors 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 cen- tered on a foundation of equity and public good, con- sistent with Executive Order 13985 of January 20, 2021 (Advancing Racial Equity and Support for Underserved Communities Through the Federal Government) [5 U.S.C. 601 note]; 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. To achieve these objectives, it is the policy of my Ad- ministration to: (a) bolster and coordinate Federal investment in key research and development (R&D) areas of bio- technology 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 respon- sible conduct of research; (c) improve and expand domestic biomanufacturing production capacity and processes, while also increas- ing 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 ad- vance 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 corner- stone of the life cycle of biotechnology and biomanu- facturing R&D, including by providing for research and investment in applied biosafety and biosecurity innova- tion; (i) promote standards, establish metrics, and develop systems to grow and assess the state of the bio- economy; to better inform policy, decision-making, and investments in the bioeconomy; and to ensure equi- table 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, manipula- tion, and exfiltration efforts by foreign adversaries), and by partnering with the private sector and other rel- evant 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 con- sistent with United States principles and values and that promotes best practices for safe and secure bio- technology and biomanufacturing research, innovation, and product development and use. The efforts undertaken pursuant to this order to fur- ther these policies shall be referred to collectively as the National Biotechnology and Biomanufacturing Ini- tiative. SEC. 2. Coordination. The Assistant to the President for National Security Affairs (APNSA), in consultation with the Assistant to the President for Economic Pol- icy (APEP) and the Director of the Office of Science and Technology Policy (OSTP), shall coordinate the ex- ecutive branch actions necessary to implement this order through the interagency process described in Na- tional Security Memorandum 2 of February 4, 2021 (Re- newing 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 appro- priate and consistent with applicable law, consult out- Page 9314 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 19131 side stakeholders, such as those in industry; academia; nongovernmental organizations; communities; labor unions; and State, local, Tribal, and territorial govern- ments 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 [Sept. 12, 2022], the heads of agencies specified in subsections (a)(i)–(v) of this section shall submit the following reports on biotechnology and bio- manufacturing to further societal goals related to health, climate change and energy, food and agricul- tural innovation, resilient supply chains, and cross-cut- ting 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 Presi- dent 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 bio- manufacturing to achieve medical breakthroughs, re- duce 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 agri- cultural 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 biomanufac- turing 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 sec- tion 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 recommenda- tions 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 appro- priate agencies as determined through the NSM–2 proc- ess, shall develop a plan (implementation plan) to im- plement the recommendations in the reports. The de- velopment of this implementation plan shall also in- clude the solicitation of input from external experts re- garding potential ethical implications or other societal impacts, including environmental sustainability and environmental justice, of the recommendations con- tained in the reports required under subsection (a) of this section. The implementation plan shall include as- sessments and make recommendations regarding any such implications or impacts. (d) Within 90 days of the date of this order, the Direc- tor of OMB, in consultation with the heads of appro- priate agencies as determined throughthe NSM–2 proc- ess, shall perform a budget crosscut to identify existing levels of agency spending on biotechnology- and bio- manufacturing-related activities to inform the develop- ment of the implementation plan described in sub- section (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 sub- mitted pursuant to subsection (a) of this section, along with the implementation plan required under sub- section (c) of this section, in which they make any ad- ditional overall recommendations for advancing bio- technology and biomanufacturing. (g) Within 2 years of the date of this order, agencies at which recommendations are directed in the imple- mentation 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 en- hance 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 Tech- nology shall submit to the President and make publicly available a report on the bioeconomy that provides rec- ommendations on how to maintain United States com- petitiveness in the global bioeconomy. SEC. 4. Data for the Bioeconomy. (a) In order to facili- tate development of the United States bioeconomy, my Administration shall establish a Data for the Bio- economy 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 develop- ment 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, inter- operable, and reusable in ways that are equitable, standardized, secure, and transparent, and that are in- tegrated with platforms that enable the use of ad- vanced 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 coordina- tion 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 Page 9315 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 19131 OMB, shall identify and recommend relevant cybersecurity best practices for biological data stored on Federal Government information systems, con- sistent with applicable law and Executive Order 14028 of May 12, 2021 (Improving the Nation’s Cybersecurity) [44 U.S.C. 3551 note]. (c) The Secretary of Commerce, acting through the Director of NIST and in coordination with the Sec- retary of HHS, shall consider bio-related software, in- cluding software for laboratory equipment, instrumen- tation, and data management, in establishing baseline security standards for the development of software sold to the United States Government, consistent with sec- tion 4 of Executive Order 14028. SEC. 5. Building a Vibrant Domestic Biomanufacturing Ecosystem. (a) Within 180 days of the date of this order [Sept. 12, 2022], the APNSA and the APEP, in coordina- tion 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 do- mestic biomanufacturing capacity for products span- ning the health, energy, agriculture, and industrial sec- tors, with a focus on advancing equity, improving bio- manufacturing processes, and connecting relevant in- frastructure. Additionally, this strategy shall identify actions to mitigate risks posed by foreign adversary in- volvement 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 strat- egy developed pursuant to subsection (a) of this sec- tion: (i) the NSF shall expand its existing Regional Innova- tion Engine program to advance emerging tech- nologies, including biotechnology; (ii) the Department of Commerce shall address chal- lenges in biomanufacturing supply chains and related biotechnology development infrastructure; (iii) the Department of Defense shall incentivize the expansion of domestic, flexible industrial biomanufac- turing 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 ad- vances, to accelerate biotechnology and bioinformatics tool development, and to reduce the hurdles to com- mercialization, including through incentivizing the en- gineering scale-up of promising biotechnologies and the expansion of biomanufacturing capacity. (c) Within 1 year of the date of this order, the Sec- retary 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 bio- manufacturing and biobased product manufacturing, while also advancing food security, environmental sus- tainability, 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 Sec- retary of Homeland Security, in coordination with the heads of appropriate agencies as determined by the Secretary, shall: (i) provide the APNSA with vulnerability assess- ments of the critical infrastructure and national crit- ical functions associated with the bioeconomy, includ- ing cyber, physical, and systemic risks, and rec- ommendations to secure and make resilient these com- ponents of our infrastructure and economy; and (ii) enhance coordination with industry on threat in- formation sharing, vulnerability disclosure, and risk mitigation for cybersecurity and infrastructure risks to the United States bioeconomy, including risks to bi- ological data and related physical and digital infra- structure and devices. This coordination shall be in- formed in part by the assessments described in sub- section (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 (in- cluding contracting officers, purchase card managers, and purchase card holders) complete training on biobased product purchasing. The Office of Federal Pro- curement Policy, within OMB, in cooperation with the Secretary of Agriculture, shall provide training mate- rials for procuring agencies. (c) Within 180 days of the date of this order and annu- ally thereafter, procuring agencies shall report pre- vious 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 di- rect 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 dur- ing 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 annu- ally thereafter, the Director of OMB shall publish infor- mation 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 pur- chasing. (f) Within 1 year of the date of this order and annu- ally thereafter, procuring agencies shall report to the Secretary of Agriculture specific categories of biobased products that are unavailable to meet their procure- ment needs, along with desired performance standards for currently unavailable products and other relevant specifications. The Secretary of Agriculture shall pub- lish 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 pre- scribed by 7 U.S.C. 8102. (g) Procuring agencies shall strive to increase by 2025 the amount of biobased product obligations or the num- ber or dollar value of biobased-only contracts, as re- flected in the information described in subsection (c) of this section, and as appropriate and consistent with ap- plicable law. SEC. 7. Biotechnology and Biomanufacturing Workforce. (a) The United States Government shall expand train- ing 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-discipli- nary education programs. This plan shall promote the implementation of formal and informal education and Page 9316 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 19131 training (such as opportunities at technical schools and certificate programs), career and technical education, and expanded career pathways into existing degree pro- grams for biotechnology and biomanufacturing. This plan shall also include a focused discussion of Histori- cally Black Colleges and Universities, Tribal Colleges and Universities, and Minority Serving Institutions and the extent to which agencies can use existing stat- utory 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 regu- latory system for biotechnology products can be con- fusing and create challenges for businesses to navigate. To improve the clarity and efficiency of the regulatory process for biotechnology products, and to enable prod- ucts that further the societal goals identified in section 3 of this order, the Secretary of Agriculture, the Ad- ministrator of the Environmental Protection Agency, and the Commissioner of Food and Drugs, in coordina- tion with the Director of OMB, the ADPD, and the Di- rector of OSTP, shall: (a) within 180 days of the date of this order, identify areas of ambiguity, gaps, or uncertainties in the Janu- ary 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 Agricul- tural Biotechnology Products) [7 U.S.C. 3121 note], in- cluding 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 sub- section (a) of this section, provide to the general public plain-language information regarding the regulatory roles, responsibilities, and processes of each agency, in- cluding 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 Di- rector of OSTP with processes and timelines to imple- ment regulatory reform, including identification of the regulations and guidance documents that can be up- dated, 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 devel- oped pursuant to Executive Order 13874 by including on the website the information developed under subsection (b) of this section, and by enabling developers of bio- technology products to submit inquiries about a par- ticular product and promptly receive a single, coordi- nated 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 annu- ally thereafter for a period of 3 years, provide an up- date regarding progress in implementing this section to the Director of OMB, the United States Trade Rep- resentative (USTR), the APNSA, the ADPD, and the Di- rector 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 rec- ommend additional executive actions and legislative proposals to achieve such goals. SEC. 9. Reducing Risk by Advancing Biosafety and Bio- security. (a) The United States Government shall launch a Biosafety and Biosecurity Innovation Initia- tive, which shall seek to reduce biological risks associ- ated with advances in biotechnology, biomanufac- turing, and the bioeconomy. Through the Biosafety and Biosecurity Innovation Initiative—which shall be es- tablished by the Secretary of HHS, in coordination with the heads of other relevant agencies as determined by the Secretary—agencies that fund, conduct, or spon- sor life sciences research shall implement the following actions, as appropriate and consistent with applicable law: (i) support, as a priority, investments in applied bio- safety research and innovations in biosecurity to re- duce 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 enter- prises. (b) Within 180 days of the date of this order, the Sec- retary 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, includ- ing recommendations to: (i) enhance applied biosafety research and bolster in- novations 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 bio- safety 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 ef- forts 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 [Sept. 12, 2022], 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 appro- priate, create and make publicly available a lexicon for the bioeconomy, with consideration of relevant domes- tic 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 arti- ficial intelligence tools. (b) The Chief Statistician of the United States, in co- ordination with the Secretary of Agriculture, the Sec- retary of Commerce, the Director of NSF, and the heads of other appropriate agencies as determined by the Chief Statistician, shall improve and enhance Fed- eral 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 Eco- nomic Analysis, the feasibility, scope, and costs of de- veloping a national measurement of the economic con- tributions of the bioeconomy, and, in particular, the contributions of biotechnology to the bioeconomy, in- cluding recommendations and a plan for next steps re- garding whether development of such a measurement should be pursued; and (ii) within 120 days of the date of this order, estab- lishing an Interagency Technical Working Group (ITWG), chaired by the Chief Statistician of the United States, which shall include representatives of the De- partment of Agriculture, the Department of Commerce, OSTP, the NSF, and other appropriate agencies as de- termined by the Chief Statistician of the United States. Page 9317 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 19131 (A) Within 1 year of the date of this order, the ITWG shall recommend bioeconomy-related revisions to the North American Industry Classification Sys- tem (NAICS) and the North American Product Classi- fication System (NAPCS) to the Economic Classifica- tion Policy Committee. In 2026, the ITWG shall ini- tiate 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 statis- tical 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 revi- sions 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 Bio- economy. (a) The Director of National Intelligence (DNI) shall lead a comprehensive interagency assess- ment of ongoing, emerging, and future threats to United States national security from foreign adver- saries against the bioeconomy and from foreign adver- sary 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 applica- tions 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 re- lated to: (i) threats to United States national and economic se- curity posed by foreign adversary development and ap- plication of biomanufacturing; and (ii) foreign adversary means of, and intended usages related to, acquisition of United States biotech- nologies, biological data, and proprietary or precompetitive information. (c) Within 120 days of receiving the DNI’s assess- ments, 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 as- sessments described in section 5(d) of this order, and other relevant assessments or information. The plan shall identify where executive action, regulatory ac- tion, technology protection, or statutory authorities are needed to mitigate these risks in order to support the technology leadership and economic competitive- ness of the United States bioeconomy. (d) The United States Government contracts with a variety of providers to support its functioning, includ- ing by contracting for services related to the bio- economy. 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) [see Tables for classification]. 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 Sec- retary of Energy, the Secretary of Homeland Security, the DNI, the Administrator of NASA, and the Adminis- trator of General Services, shall review the national se- curity implications of existing requirements related to Federal procurement—including requirements con- tained in the Federal Acquisition Regulation (FAR) and the Defense Federal Acquisition Regulation Sup- plement—and shall recommend updates to those re- quirements to the FAR Council, the Director of OMB, and the heads of other appropriate agencies as deter- mined through the NSM–2 process. The recommenda- tions shall aim to standardize pre-award data collec- tion to enable due diligence review of conflict of inter- est; conflict of commitment; foreign ownership, con- trol, or influence; or other potential national security concerns. The recommendations shall also include leg- islative 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 inter- national partners as part of their missions shall under- take the following actions with foreign partners, as ap- propriate and consistent with applicable law—with a specific focus on developing countries, international or- ganizations, and nongovernmental entities—to promote and protect both the United States and global bio- economies: (i) enhance cooperation, including joint research projects and expert exchanges, on biotechnology R&D, especially in genomics; (ii) encourage regulatory cooperation and the adop- tion of best practices to evaluate and promote innova- tive products, with an emphasis on those practices and products that support sustainability and climate objec- tives; (iii) develop joint training arrangements and initia- tives 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 ac- cess and benefit-sharing mechanisms do not hinder the rapid and sustainable development of innovative prod- ucts 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 na- tional security threats; (vii) develop, and work to promote and implement, biosafety and biosecurity best practices, tools, and re- sources bilaterally and multilaterally to facilitate ap- propriate oversight for life sciences, dual-use research of concern, and research involving potentially pan- demic 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 classifica- tions 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 Sec- retary 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 orga- nizations, 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 proc- esses 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. Page 9318 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 19132 (e) The term ‘‘biological data’’ means the informa- tion, including associated descriptors, derived from the structure, function, or process of a biological system(s) that is measured, collected, or aggregated for analysis. (f) The term ‘‘biomass’’ means any material of bio- logical origin that is available on a renewable or recur- ring 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 com- bined information derived from data, analysis, and in- terpretation of multiple omics measurement tech- nologies to identify or analyze the roles, relationships, and functions of biomolecules (including nucleic acids, proteins, and metabolites) that make up a cell or cel- lular system. Omics are disciplines in biology that in- clude genomics, transcriptomics, proteomics, and metabolomics. (j) The term ‘‘key R&D areas’’ includes fundamental R&D of emerging biotechnologies, including engineer- ing biology; predictive engineering of complex biologi- cal 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, in- cluding the development of new information, criteria, tools, models, and approaches to inform and assist reg- ulatory 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 commu- nities’’ have the meanings given those terms by sec- tions 2(a) and 2(b) of Executive Order 13985 [5 U.S.C. 601 note]. (l) The term ‘‘Tribal Colleges and Universities’’ has the meaning given that term by section 5(e) of Execu- tive Order 14049 of October 11, 2021 (White House Initia- tive on Advancing Educational Equity, Excellence, and Economic Opportunity for Native Americans and Strengthening Tribal Colleges and Universities) [20 U.S.C. 7401 note]. (m) The term ‘‘Historically Black Colleges and Uni- versities’’ has the meaning given that term by section 4(b) of Executive Order 14041 of September 3, 2021 (White House Initiative on Advancing Educational Eq- uity, Excellence, and Economic Opportunity Through Historically Black Colleges and Universities) [20 U.S.C. 1060 note]. (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) [listed in a table under 50 U.S.C. 1701]. (p) The term ‘‘life sciences’’ means all sciences that study or use living organisms, viruses, or their prod- ucts, including all disciplines of biology and all appli- cations of the biological sciences (including bio- technology, genomics, proteomics, bioinformatics, and pharmaceutical and biomedical research and tech- niques), 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 de- partment or agency, or the head thereof; or (ii) the functions of the Director of OMB relating to budgetary, administrative, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appro- priations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforce- able 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. J.R. BIDEN, JR. § 19132. National Engineering Biology Research and Development Initiative (a) In general The President, acting through the Office of Science and Technology Policy, shall implement a National Engineering Biology Research and Development Initiative to advance societal well- being, national security, sustainability, and eco- nomic productivity and competitiveness through the following: (1) Advancing areas of research at the inter- section of the biological, physical, chemical, data, and computational and information sciences and engineering to accelerate sci- entific understanding and technological inno- vation in engineering biology. (2) Advancing areas of biomanufacturing re- search to optimize, standardize, scale, and de- liver new products and solutions. (3) Supporting social and behavioral sciences and economics research that advances the field of engineering biology and contributes to the development and public understanding of new products, processes, and technologies. (4) Improving the understanding of engineer- ing biology of the scientific and lay public and supporting greater evidence-based public dis- course about its benefits and risks. (5) Supporting research relating to the risks and benefits of engineering biology, including under subsection (d). (6) Supporting the development of novel tools and technologies to accelerate scientific understanding and technological innovation in engineering biology. (7) Expanding the number of researchers, educators, and students and a retooled work- force with engineering biology training, in- cluding from traditionally underrepresented and underserved populations. (8) Accelerating the translation and com- mercialization of engineering biology and bio- manufacturing research and development by the private sector. (9) Improving the interagency planning and coordination of Federal Government activities related to engineering biology. (b) Initiative activities The activities of the Initiative shall include the following: (1) Sustained support for engineering biology research and development through the fol- lowing: (A) Grants to fund the work of individual investigators and teams of investigators, in- cluding interdisciplinary teams. (B) Projects funded under joint solicita- tions by a collaboration of not fewer than two agencies participating in the Initiative. (C) Interdisciplinary research centers that are organized to investigate basic research questions, carry out technology develop- ment and demonstration activities, and in-