By Lisa R. Burchi, James V. Aidala, and Heather F. Collins, M.S.

On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. According to EPA’s May 25, 2023, press release, this rule will reduce costs for the regulated community and result in increased research and development activities, consistent with Executive Order 14081 on advancing biotechnology. EPA states that the rule also may result in the commercialization of new pest control options and reduced use of conventional pesticides. The final rule will be effective on July 31, 2023.

EPA states the final rule will allow PIPs to be exempt from FIFRA registration and FFDCA tolerance requirements in cases where they both pose no greater risk than PIPs that EPA has already concluded meet safety requirements, and when they could have otherwise been created through conventional breeding. The final rule reflects the biotechnological advances made since 2001, when EPA first exempted PIPs derived through conventional breeding from FIFRA registration and FFDCA tolerance requirements but did not at that time exempt PIPs created through biotechnology.

In the rule, EPA provides criteria and definitions that identify two categories of PIPs that are exempted through this action from FIFRA registration and FFDCA tolerance requirements:

• “PIPs created through genetic engineering from a sexually compatible plant” in which genetic engineering has been used to insert or modify a gene to match a gene found in a sexually compatible plant (to be codified at 40 C.F.R. Section 174.26); and
• “Loss-of-function PIPs” in which the genetically engineered modification reduces or eliminates the activity of a gene, which then helps make the plant resistant to pests (to be codified at 40 C.F.R. Section 174.27).

For the first exempted category, EPA will require a notification process for EPA to confirm that the PIP is eligible for the exemption. For the second exempted category (loss-of-function PIPs), developers of PIPs can submit to EPA a self-determination letter that the exemption applies. EPA also is establishing recordkeeping requirements for these exempted PIPs, clarifying general qualifications for exemption at 40 C.F.R. Section 174.21; clarifying the relationship between the existing exemptions for PIPs from sexually compatible plants (40 C.F.R. Section 174.25) and the newly issued exemption for “PIPs created through genetic engineering from a sexually compatible plant” (40 C.F.R. Section 174.26); and allowing the existing inert ingredient exemption at 40 C.F.R. Section 174.705 to include genetic engineering.

EPA notes that in the future, as biotechnology advances further, it intends to consider exempting additional categories of PIPs from both FIFRA registration and FFDCA tolerance requirements as well as adding categories of exempted PIPs to the list of categories that do not require EPA confirmation of eligibility.

Additional information, including the response to comment document, is available in docket EPA-HQ-OPP-2019-0508.

Commentary

This final rule is the next step for EPA’s Office of Pesticide Programs (OPP) on the path of EPA’s regulation of biotechnology pesticide products. It sets forth how OPP will handle products created by “Clustered Regularly Interspaced Short Palindromic Repeats” (CRISPR). In more general terms, CRISPR refers to manipulating plant genes with a method that was not available at the time the first biotechnology regulations were developed by EPA in the mid-1990s. This is why EPA needs to “update” its regulations, which is the purpose of the final rule.

Proponents of biotechnology methods argue that CRISPR allows the genes of plants to be manipulated more precisely and can be used to “simply” drop out a gene or add one from the same -- sexually compatible -- genome of the target plant. It follows that this is much like “traditional plant breeding” only done more precisely and more rapidly. Critics will likely raise questions about whether any product using this method, and not using traditional methods, might have some kind of unexpected result or unintended eventual effect. One can expect some adverse comments regarding these products even though EPA (among many others) lays out a rationale that this is an extension of its current regulations exempting products of traditional plant breeding from regulation under FIFRA/FFDCA (and not exempting such products from other regulatory authorities).

There also were concerns raised in comments submitted in response to the October 9, 2020, proposed rule. In particular, some in industry remain concerned that the final rule creates differential treatment for products due solely to the methods of development (i.e., biotechnology vs. conventional), thus subjecting products created using biotechnology to additional regulatory and recordkeeping requirements, even in cases when those products could have been created using older research and development approaches.

EPA’s basic requirements for biotechnology products that regulate inter-species gene manipulation would not change. Also worth noting is that the rule also would allow a developer to submit the product for EPA review to affirm that it qualifies for the exemption (i.e., a M009 Pesticide Registration Improvement Act (PRIA) action, which can lead to EPA delays in processing). The EPA docket includes a slide deck with a helpful summary of the final rule and its rationale.

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By Lynn L. Bergeson and Carla N. Hutton
 
On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposed rule includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” EPA proposed several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Comments are due July 25, 2023. More information on the proposed rule is available in our May 24, 2023, memorandum.
 
When EPA receives a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN), EPA states that it is required to assess the risk associated with the new chemical substance or significant new use that is the subject of the notice under the conditions of use and make a determination for the chemical substance pertaining to the likelihood of such risk. EPA notes that under TSCA, the term “chemical substance” includes microorganisms. To improve the effectiveness and efficiency of these reviews, EPA proposes to amend the procedural regulations at 40 C.F.R. Parts 720, 721, and 725 to align with the requirements in TSCA Section 5, as amended by the Lautenberg Act, and to make additional updates. In particular, EPA proposes to amend the regulations to specify that EPA must make a determination on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing of the chemical substance, and to list the five possible determinations and the actions required in association with those determinations. In addition, EPA proposes to clarify the level of detail expected for the information that a submitter is required to include in a PMN, SNUN, or exemption notice for the notice to be considered complete. EPA also proposes amendments to the procedures for reviewing PMNs and SNUNs; specifically, procedures for addressing PMNs and SNUNs that have errors or are incomplete or that are amended during the applicable review period. Additionally, EPA is proposing to make several amendments to the regulations at 40 C.F.R. Section 723.50 for LVEs and LoREXs. According to EPA, these amendments would require EPA approval of an exemption notice before the submitter may commence manufacture, allow EPA to inform an LVE or LoREX holder when the chemical substance that is the subject of the exemption becomes subject to a significant new use rule (SNUR) and the chemical identity is confidential, make PFAS categorically ineligible for these exemptions, and codify EPA’s use of the 1999 PBT policy for these exemptions by making certain PBTs ineligible for these exemptions. Finally, EPA proposes to amend the regulations pertaining to suspensions for all TSCA Section 5 notices to allow submitters to request suspensions for up to 30 days via oral or e-mail request.

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By Lynn L. Bergeson and Carla N. Hutton
 
On April 25, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it published a new five-year strategic plan. According to APHIS, it incorporates input it received from stakeholders on the strategic framework, a summarized version of the plan that it published in June 2022. The plan includes six strategic goals that focus on working to:

• Protect agriculture from plant and animal diseases and pests. Objective 5 is “Ensure the development of safe agricultural biotechnology products using a science-based regulatory framework.” This includes:
   
  • Conducting efficient risk-based permit review and issuance for organisms developed using genetic engineering to ensure they are safely contained or confined during movement or release;
     
  • Using plain language to communicate clearly APHIS regulations, expectations, and guidance to stakeholders, particularly those working with modified non-plant organisms potentially subject to APHIS regulations; helping stakeholders understand regulations through outreach, workshops, toolkits, and other means; and
     
  • Working with the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) to increase coordination and harmonization of regulatory oversight for biotechnology products within each agency’s existing statutory framework;
     
• Cultivate a talented, diverse, and public service-focused workforce where employees are supported, valued, and engaged;
   
• Reduce the impacts of zoonotic and emerging diseases and climate change. Objective 3 is “Mitigate and adapt to the effects of climate change.” This includes:
   
  • Incorporating climate change scenarios when evaluating the plant pest risk associated with biotechnology products; and
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  • Working with federal partners to develop clear, efficient, predictable, and risk-based regulatory pathways for safely bringing microbial and other new products that help address climate change to market, and helping developers of such products navigate the regulatory system;
     
• Maintain and expand the safe trade of agricultural products nationally and internationally. Objective 2, “Maintain and expand the Agency’s leadership role through international standard setting and collaboration,” includes promoting engagement, collaboration, and harmonization of agricultural biotechnology regulation with trading partners, the Organization for Economic Cooperation and Development (OECD), and other international and regional organizations. Objective 3, “Create safe export opportunities,” includes:
   
  • Communicating to international stakeholders about APHIS’ processes and share outcomes of biotechnology product evaluations;
     
  • Working with trade agencies on technical aspects of trade in biotechnology products; and
     
  • Working with the regulatory authorities of U.S. trading partners to harmonize further regulatory frameworks for biotechnology products;
     
• Manage wildlife damage and threats to agriculture, natural resources, property, and people; and
   
• Promote the welfare of animals.

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By Lynn L. Bergeson and Carla N. Hutton
 
The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. 88 Fed. Reg. 25711. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” Under the EO, the Chief Statistician of the United States (CSOTUS) in OMB’s Office of Information and Regulatory Affairs (OIRA) was charged with improving and enhancing federal statistical data collection designed to characterize and measure the economic value of the U.S. bioeconomy. The CSOTUS was also charged with establishing an Interagency Technical Working Group (Working Group) to recommend bioeconomy-related revisions for the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS). OMB states that the bioeconomy refers to a segment of the total economy utilizing or derived from biological resources and includes manufacturing processes, technologies, products, and services. These may encompass, wholly or in part, industries and products including fuel, food, medicine, chemicals, and technology. To ensure consideration of comments on potential bioeconomy-related industries and products solicited in the RFI, OMB asked that all comments be submitted “as soon as possible,” but no later than June 12, 2023.
 
The Working Group, through OMB, seeks input on how to identify, classify, and measure best bioeconomy manufacturing, technology, and products, including those that are primarily or exclusively: (a) biobased, (b) components of traditional manufacturing processes, and (c) nascent biobased processes and products. Importantly, according to OMB, input should include information on how particular industries or products are linked to the bioeconomy and, where appropriate and available, evidence should be provided. OMB states that this will afford the Working Group the opportunity to use existing evidence to inform its recommendations. The RFI includes the following questions:

• What information and what high-priority concerns should the Working Group consider in making these recommendations for potential revisions to the NAICS and NAPCS that would enable characterization of the economic value of the U.S. bioeconomy?
   
• Which quantitative economic indicators and processes are currently used to measure the contributions of the U.S. bioeconomy? Are these indicators reasonably accurate measures of the product components, scope, and value of the bioeconomy? Please explain why.
   
• Which industries not currently measured as unique classifications in NAICS related to the bioeconomy should be considered? Similarly, which products not currently measured as unique classifications in NAPCS related to the bioeconomy should be considered? Please describe how a unique classification for such industry or product would meet the principles of NAICS and NAPCS. Please include a description of the industry or product, with specific examples. Please also provide an explanation of how such industry or product would advance understanding of measuring the bioeconomy.
   
• How might potential changes to the NAICS impact existing industry measurements, such as assessing changes in the economic output across current industries, time series measures, or data accuracy?
   
• What role can the NAPCS fill in order to advance measurement of biomanufacturing and biotechnology?
   
• Biobased processes and products that are embedded in traditional industries pose challenges for differentiation and measurement. Are there methodologies that can differentiate these bioeconomy processes from current manufacturing processes to enable measurement? If yes, please explain.
   
• What potential bioeconomy measurement strategies might be considered other than revisions to and inclusion in the NAICS or NAPCS? For example, are there ways the federal government could better collect information to provide better measurement on biobased processes or products in current industries?

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By Lynn L. Bergeson and Carla N. Hutton
 
On April 25, 2023, the Council of the European Union (EU) announced that it approved the conclusions on the opportunities of the bioeconomy in light of current challenges, with special emphasis on rural areas. Using biomass to produce food, materials, and energy can help boost rural communities, increase competitiveness, and combat many of the challenges facing the EU. According to the press release, in their conclusions, ministers “highlighted the key role that the bioeconomy could play in achieving the environmental and climate goals under the European Green Deal, while also making the EU more competitive, helping it transition away from fossil-fuel dependency, and strengthening food security in the wake of Russia’s war of aggression against Ukraine.” The ministers also stressed the importance of promoting research and innovation and improving alignment between scientific advances and industry policy. The press release states that the conclusions will provide political guidance for the European Commission (EC) and EU member states on developing the potential of the bioeconomy in Europe.
 
While the Council of the EU welcomed the EC’s progress report on the implementation of the EU Bioeconomy Strategy, ministers put forward a number of recommendations intended to help boost the potential of the bioeconomy in Europe. In particular, they called on the EC to:

• Better integrate bioeconomy into all policies and ensure policy coherence;
• Facilitate knowledge transfer toward less developed regions and rural areas; and
• Update the EU Bioeconomy Strategy and associated action plan and carry out an in-depth assessment of actions being taken at the EU level.

Ministers also noted that the bioeconomy was an integral aspect of the reformed Common Agricultural Policy (CAP) and invited the EC to follow up on how EU member states had incorporated it into their national strategic plans.

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By Lynn L. Bergeson and Carla N. Hutton
 
President Joseph Biden’s September 12, 2022, Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative directs the U.S. Department of Commerce’s (DOC) Bureau of Economic Analysis (BEA) to assess “the feasibility, scope, and costs of developing a national measurement of the economic contributions of the bioeconomy.” As reported in our March 30, 2023, blog item, BEA released a March 2023 report on Developing a National Measure of the Economic Contributions of the Bioeconomy that assesses the feasibility of measuring the economic contributions of the U.S. bioeconomy. The report also includes an assessment of what is needed to measure these contributions better and more accurately.
 
According to the report, in the case of the bioeconomy, researchers, potential data users, and other stakeholders have different (and competing) ideas of how the bioeconomy should be defined and which industries should be included or excluded. The report states that these different ideas can be summarized into three distinct visions for the bioeconomy:

• Biotechnology: The biotechnology vision focuses on emerging industries and products enabled by innovation in the life sciences, particularly in genetic engineering; in this vision, established industries such as agriculture and forestry are typically not included;
• Bioresources: The bioresources vision focuses on understanding the flow of biological resources, such as biomass and biofuels, through the economy; in this vision, the agriculture and forestry industries are included as foundational components of the bioeconomy; and
• Bioecology: The bioecology vision focuses on the contributions of the bioeconomy to sustainability and the environment; this vision may specifically exclude some products or industries, such as genetically engineered crops.

The report states that it finds that developing a comprehensive bioeconomy satellite account encompassing all concepts of the bioeconomy appears technically feasible. The report notes that “[s]uch a broad approach would roughly correspond to similar efforts by the European Union (EU) and other international organizations but would not address data users’ preferences for an account more focused on a specific vision of the bioeconomy.” The report states that “[d]eveloping a consistent, ongoing bioeconomy satellite account broken down along the lines of specific visions of the bioeconomy, such as biotechnology, is likely infeasible at this time due to both a lack of existing data on which to base such an account and a lack of consensus on practical measurement definitions.”

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By Lynn L. Bergeson and Carla N. Hutton
 
As part of the National Biotechnology and Biomanufacturing Initiative, the U.S. Department of Defense (DOD) announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. As reported in our March 30, 2023, blog item, on March 22, 2023, DOD released its Biomanufacturing Strategy to guide these investments, and its broader efforts in this critical technology field. According to the Biomanufacturing Strategy, as commercial use of new technologies expands, if the United States fails to invest in its domestic manufacturing capabilities, market forces could drive manufacturing overseas, often at the expense of the national economy and potentially creating vulnerabilities in the DOD supply of these products.
 
The Biomanufacturing Strategy is focused around three core principles:

• Establish DOD transition partners for early-stage innovations: Establishing DOD customers for biomanufactured capabilities will guide DOD technology investments. The core of the DOD Biomanufacturing Strategy is a culture shift throughout DOD that both recognizes and prioritizes, where applicable, biotechnology-based solutions to prevent strategic surprise.
• Develop the field of biomanufacturing through innovations in practice and application; According to the Biomanufacturing Strategy, research is required in scaling-up biomanufacturing to produce at a scale sufficient to prototype these products. The Biomanufacturing Strategy states although this is a hurdle in adopting biotechnology-based solutions to DOD mission needs, “it is also an incredible opportunity to develop biomanufacturing at home and with allies and partners to create a self-sustaining domestic biomanufacturing ecosystem.” It will also contribute to the United States remaining the “world leader in innovation,” guarantee DOD interests are protected, and ensure that U.S. global competitiveness in biotechnology is maintained.
• Map the domestic biomanufacturing ecosystem and the changes that occur over time for identification and tracking of metrics to support future implementation and refinement of the biomanufacturing strategy: According to the Biomanufacturing Strategy, for DOD to build enduring advantage through the implementation of the Biomanufacturing Strategy, DOD needs to address implementation risk. Concurrent with DOD’s need to prioritize where it places its resources in biomanufacturing, DOD “will support an upfront assessment of the biomanufacturing ecosystem, along with continued evaluation during and following early investments, allowing for more precise tailoring” of DOD resource allocation as the biomanufacturing ecosystem develops. The Biomanufacturing Strategy states that mapping the biomanufacturing ecosystem and establishing metrics to evaluate the bioeconomy “is central to mitigating implementation risk.”

In support of the Biomanufacturing Strategy, DOD issued a formal request for information (RFI) on biomanufactured products and process capabilities that could help address defense needs and whose development and commercialization could be addressed by DOD investment. The intent of the RFI is to gather information about U.S. national security industrial base shortcomings, risks, and opportunities that may be addressed by investments made under the provisions in Title III of the Defense Production Act (DPA). According to the RFI, biomanufactured products of interest include those that “enable capabilities within the following application and operational spaces of interest, and will bring revolutionary changes to military capabilities, the operations environment, and supply chain resiliency.” Such application and operational spaces may include, but are not necessarily limited to:

• Manufacture specialty chemicals and materials that are needed by DOD in an available and affordable manner (e.g., biomanufactured fuels and energetic precursors, biosynthetic fibers such as but not limited to spider silk, polymers, natural rubber/latex rubber, solvents);
• Enable reduced logistic costs, time, and energy through bio-composite and living materials (e.g., tunable materials with enhanced properties, self-healing materials);
• Maintain persistent sensing capabilities for sustained human and environmental intelligence (e.g., sensors for water quality monitoring, biobased energy harvesting in maritime systems);
• Augment human systems by impacting performance and protection (e.g., tailored proteins, but specifically excluding biopharma and probiotics); and
• Enable manufacturing defense relevant materials in a manner to reduce the impact on the environment while meeting or exceeding product performance requirements.

Responses are due by April 19, 2023, at 12:00 p.m. (EDT). The RFI notes that if late information is received, the government reviewers may consider it, depending on agency time constraints.

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By Lynn L. Bergeson and Carla N. Hutton

As reported in our March 30, 2023, blog item, on March 22, 2023, the White House Office of Science and Technology Policy (OSTP) released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals. The report includes five sections, each presenting goals that highlight what could be possible with the power of biology. The goals set ambitious national targets for the next two decades to help establish research and development (R&D) priorities that will be critical to advance the bioeconomy. Each section also outlines the essential R&D needed to achieve these goals for the U.S. bioeconomy, opportunities for public-private collaboration, and recommendations for enhancing biosafety and biosecurity. The report notes that achieving these goals will require significant prioritization of R&D investments and other efforts across the U.S. government, as well as actions from the private sector; state, local, and Tribal governments; and international partners.
 
The report states that bold goals for the U.S. bioeconomy include, for example:

• Climate: In 20 years, demonstrate and deploy cost-effective and sustainable routes to convert biobased feedstocks into recyclable-by-design polymers that can displace more than 90 percent of today’s plastics and other commercial polymers at scale;
• Food and Agriculture: By 2030, reduce methane emissions from agriculture, including by increasing biogas capture and utilization from manure management systems, reducing methane from ruminant livestock, and reducing methane emissions from food waste in landfills, to support the U.S. goal of reducing greenhouse gas (GHG) emissions by 50 percent and the global goal of reducing methane emissions by 30 percent;
• Supply Chain: In 20 years, produce at least 30 percent of the U.S. chemical demand via sustainable and cost-effective biomanufacturing pathways;
• Health: In 20 years, increase the manufacturing scale of cell-based therapies to expand access, decrease health inequities, and decrease the manufacturing cost of cell-based therapies tenfold; and
• Cross-Cutting Advances: In five years, sequence the genomes of one million microbial species and understand the function of at least 80 percent of the newly discovered genes.

According to this report, reaching these goals will require progress in other areas beyond R&D to ensure that innovation can lead to safe, effective, and equitable products that will grow the bioeconomy. The report states that in forthcoming reports and plans, departments and agencies will outline recommendations and steps that are underway to advance the following:

• Data for the bioeconomy -- Establishing a Data Initiative to ensure that high-quality, wide-ranging, easily accessible, and secure biological data sets can drive breakthroughs for the U.S. bioeconomy;
• Domestic biomanufacturing infrastructure -- Expanding domestic capacity to manufacture all the biotechnology products invented in the United States and to support a resilient supply chain;
• Workforce development -- Growing training and educational opportunities for the biotechnology and biomanufacturing workforce of the future;
• Regulatory clarity and efficiency -- Improving the clarity and efficiency of the regulatory process for biotechnology products to help ensure products come to market safely and efficiently;
• Biosafety and biosecurity -- Creating a Biosafety and Biosecurity Innovation Initiative to reduce risks associated with advances in biotechnology and biomanufacturing; and
• International engagement R&D -- Pursuing cooperation through joint research projects and data sharing, while mitigating risks and reaffirming democratic values.

According to the report, OSTP will lead the development of a strategy and implementation plan to execute on R&D priorities and other actions identified in the report.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, President Joseph Biden signed an Executive Order (EO) on September 12, 2022, creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On March 22, 2023, the White House Office of Science and Technology Policy (OSTP) published a fact sheet announcing “new bold goals and priorities that will catalyze action inside and outside of government to advance American biotechnology and biomanufacturing”:

• Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals: On March 22, 2023, OSTP released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals, outlining a vision for what is possible with the power of biotechnology and biomanufacturing and the R&D needs to achieve this ambitious vision. Biden’s EO called on federal departments and agencies to assess the potential for biotechnology and biomanufacturing R&D to further five societal goals: climate change solutions; food and agricultural innovation; supply chain resilience; human health; and crosscutting advances. The report includes individual sections authored by the Department of Energy (DOE), the U.S. Department of Agriculture (USDA), the Department of Commerce (DOC), the Department of Health and Human Services (DHHS), and the National Science Foundation (NSF), in consultation with other agencies and departments, that are responsive to the President’s EO. The goals and R&D needs outlined in the report serve as a guide for public- and private-sector efforts to harness the full potential and power of biotechnology and biomanufacturing to develop innovative solutions in different sectors, create jobs at home, build stronger supply chains, lower costs for families, and achieve our climate goals. According to the fact sheet, OSTP will now lead the development of an implementation plan to address the R&D needs outlined in the report.
   
• Establishing Biomanufacturing Priorities for DOD: As part of the National Biotechnology and Biomanufacturing Initiative, DOD announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. On March 22, 2023, DOD released its Biomanufacturing Strategy to guide these investments, and its broader efforts in this critical technology field. This strategy, which will guide research efforts and collaboration with the private sector and allies, sets three key priorities: establishing the customers within DOD that stand to benefit from early-stage innovations, advancing biomanufacturing capabilities through innovation, and mapping the biomanufacturing ecosystem and tracking metrics that support future efforts. In support of the strategy, DOD issued a formal request for information on biomanufactured products and process capabilities that could help address defense needs and whose development and commercialization could be addressed by DOD investment.
   
• Assessing the Economic Value of the Nation’s Bioeconomy: DOC’s Bureau of Economic Analysis released a new report that assesses the feasibility of measuring the economic contributions of the U.S. bioeconomy. The report also includes an assessment of what is needed to measure these contributions better and more accurately.

According to the fact sheet, other deliverables from the EO are in development, including: a plan to expand training and education opportunities for the biotechnology and biomanufacturing workforce, a report on data needs for the bioeconomy, a national strategy for expanding domestic biomanufacturing capacity, actions to improve biotechnology regulation clarity and efficiency, and a plan for strengthening and innovating biosafety and biosecurity for the bioeconomy.

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By Lynn L. Bergeson and Carla N. Hutton
 
That National Academies of Sciences, Engineering, and Medicine (NASEM) hosted an October 2022 workshop on successes and challenges in biomanufacturing. The workshop brought together biomanufacturing stakeholders across industry, academia, and government with expertise across diverse fields, including United States-based and international speakers. According to NASEM, discussions spanned the breadth of biomanufacturing contexts and applications, including bioindustrial and biopharmaceutical manufacturing. NASEM’s Proceedings of a Workshop-in Brief provides a high-level summary of the topics addressed at the workshop. Topics covered include:

• Biomanufacturing for Sustainability and a Circular Bioeconomy;
• Regulation and Standards;
• Biomanufacturing Workforce Development and Education;
• Economic Considerations and Challenges in Biomanufacturing;
• Biomanufacturing Ecosystems and Partnerships;
• Translating Lessons from Different Biomanufacturing Sectors;
• Modeling, Data, Analysis, and Process Control;
• Biomanufacturing Platform Development; and
• Biomanufacturing Infrastructure and Tools for Scaling.

NASEM notes that the summary should not be viewed as consensus conclusions or recommendations of NASEM.

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