Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) published two requests for information (RFI) related to the NBBI. In the first one, OSTP, on behalf of the primary agencies that regulate the products of biotechnology -- the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) -- requests relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products. 87 Fed. Reg. 77900. According to the RFI, the information provided will inform regulatory agency efforts to improve the clarity and efficiency of the regulatory processes for biotechnology products. The RFI includes the following questions:

  1. Describe any ambiguities, gaps, inefficiencies, or uncertainties regarding statutory authorities and/or agency roles, responsibilities, or processes for different biotechnology product types, particularly for product types within the responsibility of multiple agencies.
     
    1. Describe the impact, including economic impact, of these ambiguities, gaps, inefficiencies, or uncertainties.
       
  2. Provide any relevant data or information, including case studies, that could inform improvement in the clarity or efficiency (including the predictability, transparency, and coordination) of the regulatory system and processes for biotechnology products.
     
  3. Describe any specific topics the agencies should address in plain language on the regulatory roles, responsibilities, and processes of the agencies.
     
  4. Describe any specific issues the agencies should consider in developing a plan to implement regulatory reform, including any updated or new regulations or guidance documents.
  5. Describe any new or emerging biotechnology products (e.g., microbial amendments to promote plant growth; food plants expressing non-food substances or allergens from non-plant sources) that, based on lessons learned from past experiences or other information, the agencies should pay particular attention to in their evaluation of ambiguities, gaps, or uncertainties regarding statutory authorities and/or agency roles or processes.

  6. Describe any new or emerging categories of biotechnology products on the horizon that the regulatory system and processes for biotechnology products should be preparing to address. Describe any specific recommendations for regulating these new or emerging categories of biotechnology products to guide agency preparations.

  7. What is the highest priority issue for the agencies to address in the short term (i.e., within the next year) and in the long term.

OSTP, EPA, FDA, and USDA will host a virtual public listening session on January 12, 2023. The virtual listening session will allow OSTP, EPA, FDA, and USDA to hear, firsthand, from stakeholders who wish to provide feedback on any of the seven questions outlined in the RFI. Comments are due on or before 5 p.m. (EST) February 3, 2023. More information on the Coordinated Framework for the Regulation of Biotechnology is available in our January 9, 2017, memorandum.
 
The second RFI seeks public input on how advances in biotechnology and biomanufacturing can help achieve goals that were previously out of reach and what steps can be taken to provide the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. 87 Fed. Reg. 77901. OSTP invites input from interested stakeholders, including industry and industry association groups; academic researchers and policy analysts; civil society and advocacy groups; individuals and organizations that work on biotechnology, biomanufacturing, or related topics; and members of the public. OSTP seeks responses to one, some, or all of the following questions:

Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals

  1. For any of the four categories outlined above (health, climate and energy, food and agriculture, and supply chain resilience):
     
    1. What specific bold goals can be achieved through advances in biotechnology and biomanufacturing in the short term (five years) and long term (20 years)? In your answers, please suggest quantitative goals, along with a description of the potential impact of achieving a goal. Listed below are illustrative examples of quantitative goals:
       
      1. Develop domestic bio-based routes of production, including the entire supply chain, for X percent of active pharmaceutical ingredients.
         
      2. Utilize X tons of sustainable biomass annually as input to biomanufacturing processes to displace Y percent of U.S. petroleum consumption.
    2. What R&D is needed to achieve the bold goals outlined in (a), with a focus on cross-cutting or innovative advances? How would the government support this R&D, including through existing federal programs, creation of new areas of R&D, and/or development of new mechanisms?
       
    3. How else can the government engage with and incentivize the private sector and other organizations to achieve the goals outlined in (a)?
       
  2. Public engagement and acceptance are of critical importance for successful implementation of biotechnology solutions for societal challenges. How might social, behavioral, and economic sciences contribute to understanding possible paths to success and any hurdles? What public engagement and participatory models have shown promise for increasing trust and understanding of biotechnology?

Data for the Bioeconomy

  1. What data types and sources, to include genomic and multiomic information, are most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D? What data gaps currently exist?

  2. How can the federal government, in partnership with private, academic, and non-profit sectors, support a data ecosystem to drive breakthroughs for the U.S. bioeconomy? This may include technologies, software, and policies needed for data to remain high-quality, interoperable, accessible, secure, and understandable across multiple stakeholder groups.

Building a Vibrant Domestic Biomanufacturing Ecosystem

  1. What is the current state of U.S. and global biomanufacturing capacity for health and industrial sectors, and what are the limits of current practice?

  2. What can the federal government do to expand and scale domestic biomanufacturing capacity and infrastructure? What level of investment would be meaningful, and what incentive structures could be employed?

  3. What are barriers that must be addressed to enable better domestic supply chains for biomanufacturing (e.g., feedstocks, reagents, consumables)?

  4. How can the federal government partner with state and local governments to expand domestic biomanufacturing capacity, with a particular focus on underserved communities?

Biobased Products Procurement

  1. What are new, environmentally sustainable biobased products that the federal government could purchase through its BioPreferred Program? How can the federal government incentivize development of new categories of sustainable biobased products?

    Biotechnology and Biomanufacturing Workforce

  2. How can the U.S. strengthen and expand the biotechnology and biomanufacturing workforce to meet the needs of industry today and in the future? What role can government play at the local, state, and/or federal level?

  3. What strategies and program models have shown promise for successfully diversifying access to biomanufacturing and biotechnology jobs -- including those involving Historically Black Colleges and Universities (HBCU), Tribal Colleges and Universities, and other Minority Serving Institutions? What factors have stymied progress in broadening participation in this workforce?

Reducing Risk by Advancing Biosafety and Biosecurity

  1. What can the federal government do to support applied biosafety research and biosecurity innovation to reduce risk while maximizing benefit throughout the biotechnology and biomanufacturing life cycles?
     
  2. How can federal agencies that fund, conduct, or sponsor life sciences research incentivize and enhance biosafety and biosecurity practices throughout the United States and international research enterprises?

 Measuring the Bioeconomy

  1. What quantitative indicators, economic or otherwise, are currently used to measure the contributions of the U.S. bioeconomy? Are there new indicators that should be developed?

  2. How should the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS) be revised to enable characterization of the economic value of the U.S. bioeconomy? Specifically, which codes or categories do not distinguish between functionally identical biobased and fossil fuel-based commodities?

International Engagement

  1. What are opportunities for the U.S. government to advance R&D, a skilled workforce, regulatory cooperation, and data sharing for the bioeconomy through international cooperation? Which partnerships and fora are likely keys to advance these priority areas?
     
  2. What risks are associated with international biotechnology development and use, and how can the U.S. government work with allies and partners to mitigate these risks?

Comments are due on or before 5:00 p.m. (EST) on January 20, 2023.


 

 By Lynn L. Bergeson and Carla N. Hutton
 
On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. ARS researchers evaluated nanobodies to prevent and treat citrus greening disease in citrus trees. The scientists are now using their newly developed and patented SymbiontTM technology to show that nanobodies can be easily produced in a plant system with broad agricultural and public health applications. According to ARS, as a proof-of-concept, researchers showed that nanobodies targeting the SARS-CoV-2 virus could be made in plant cells and remain functional in blocking the binding of the SARS-CoV-2 spike protein to its receptor protein: the process responsible for initiating viral infection in human cells.
 
AgroSource, Inc. collaborated with ARS to develop the plant-based production system. According to ARS, they are currently taking the necessary steps to see how they can move this advancement into the commercial sector. ARS notes that this research collaboration is in response to the White House’s Executive Order on advancing biotechnology and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on October 21, 2022, that it recently reviewed a corn plant and a potato plant that were modified using genetic engineering to determine whether they present an increased pest risk as compared to unmodified plants. APHIS has posted its Regulatory Status Review (RSR) responses on its website, as required under 7 C.F.R. Part 340. According to APHIS, the corn plant, from Infinite Enzymes, Inc., was modified to produce the enzyme manganese peroxidase in corn seed and to make it resistant to the herbicide glufosinate. The potato plant, from J.R. Simplot Company, was modified to make it resistant to potato late blight and potato virus Y and to alter the potato tuber’s sugar profile and quality.
 
According to APHIS, in both cases, it “found these plants unlikely to pose an increased plant pest risk compared to other cultivated corn and potato plants.” As a result, they are not subject to regulation under 7 C.F.R. Part 340. From a plant pest risk perspective, these plants may be safely grown and used in breeding in the United States. APHIS notes that its responses are based on information from the developers and its own:

  • Familiarity with plant varieties;
  • Knowledge of the traits; and
  • Understanding of the modifications.

Under 7 C.F.R. Part 340, developers may request an RSR when they believe a modified plant is not subject to regulation. APHIS reviews the modified plant and considers whether it might pose an increased plant pest risk compared to a nonregulated plant. If its review finds a plant is unlikely to pose an increased plant pest risk relative to the comparator plant, APHIS issues a response indicating the plant is not subject to the regulations.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture’s (USDA) Biotechnology Risk Assessment Research Grants (BRAG) program supports the generation of new information that will assist federal regulatory agencies in making science-based decisions about the environmental effects of introducing genetically engineered organisms. In an October 27, 2022, technical assistance webinar, staff will provide an overview of the program, which is jointly administered by USDA’s National Institute of Food and Agriculture (NIFA) and Agricultural Research Service (ARS), and discuss details included in the fiscal year (FY) 2023 Request for Applications (RFA). NIFA plans to invest $5.5 million in this funding opportunity, which supports applied and/or fundamental research relevant to environmental risk assessment, including biological risk, and the federal regulatory process. Applications may be submitted by any U.S. public or private research or educational institution or organization. The closing date for grant applications is January 19, 2023. Registration for the webinar is required.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) will hold its annual Stakeholder Meeting on December 8, 2022. BRS will offer in-person, at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland 20737, and virtual options for attendance. Attendees will hear updates about BRS’s implementation of the revised biotechnology regulations, including the new Regulatory Status Review and Confirmation Request processes, and other 2022 activities.
 
BRS seeks feedback on discussion topics for the meeting. Comments or suggestions on potential topics of interest are due October 14, 2022, to .(JavaScript must be enabled to view this email address). BRS will send out further meeting details and registration information. BRS states that stakeholders should check the BRS website for future meeting updates.


 

By Lynn L. Bergeson and Carla N. Hutton
 
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.” The White House hosted a Summit on Biotechnology and Biomanufacturing on September 14, 2022. According to the White House fact sheet on the summit, federal departments and agencies, with funding of more than $2 billion, will take the following actions:

  • Leverage biotechnology for strengthened supply chains: The Department of Health and Human Services (DHHS) will invest $40 million to expand the role of biomanufacturing for active pharmaceutical ingredients (API), antibiotics, and the key starting materials needed to produce essential medications and respond to pandemics. The Department of Defense (DOD) is launching the Tri-Service Biotechnology for a Resilient Supply Chain program with a more than $270 million investment over five years to turn research into products more quickly and to support the advanced development of biobased materials for defense supply chains, such as fuels, fire-resistant composites, polymers and resins, and protective materials. Through the Sustainable Aviation Fuel Grand Challenge, the Department of Energy (DOE) will work with the Department of Transportation and the U.S. Department of Agriculture (USDA) to leverage the estimated one billion tons of sustainable biomass and waste resources in the United States to provide domestic supply chains for fuels, chemicals, and materials.
     
  • Expand domestic biomanufacturing: DOD will invest $1 billion in bioindustrial domestic manufacturing infrastructure over five years to catalyze the establishment of the domestic bioindustrial manufacturing base that is accessible to U.S. innovators. According to the fact sheet, this support will provide incentives for private- and public-sector partners to expand manufacturing capacity for products important to both commercial and defense supply chains, such as critical chemicals.
     
  • Foster innovation across the United States: The National Science Foundation (NSF) recently announced a competition to fund Regional Innovation Engines that will support key areas of national interest and economic promise, including biotechnology and biomanufacturing topics such as manufacturing life-saving medicines, reducing waste, and mitigating climate change. In May 2022, USDA announced $32 million for wood innovation and community wood grants, leveraging an additional $93 million in partner funds to develop new wood products and enable effective use of U.S. forest resources. DOE also plans to announce new awards of approximately $178 million to advance innovative research efforts in biotechnology, bioproducts, and biomaterials. In addition, the U.S. Economic Development Administration’s $1 billion Build Back Better Regional Challenge will invest more than $200 million to strengthen America’s bioeconomy by advancing regional biotechnology and biomanufacturing programs.
     
  • Bring bioproducts to market: DOE will provide up to $100 million for research and development (R&D) for conversion of biomass to fuels and chemicals, including R&D for improved production and recycling of biobased plastics. DOE will also double efforts, adding an additional $60 million, to de-risk the scale-up of biotechnology and biomanufacturing that will lead to commercialization of biorefineries that produce renewable chemicals and fuels that significantly reduce greenhouse gas emissions from transportation, industry, and agriculture. The new $10 million Bioproduct Pilot Program will support scale-up activities and studies on the benefits of biobased products. Manufacturing USA institutes BioFabUSA and BioMADE (launched by DOD) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) (launched by the Department of Commerce (DOC)) will expand their industry partnerships to enable commercialization across regenerative medicine, industrial biomanufacturing, and biopharmaceuticals.
     
  • Train the next generation of biotechnologists: The National Institutes of Health (NIH) is expanding the Innovation Corps (I-Corps™), a biotech entrepreneurship bootcamp. NIIMBL will continue to offer a summer immersion program, the NIIMBL eXperience, in partnership with the National Society for Black Engineers, which connects underrepresented students with biopharmaceutical companies, and support pathways to careers in biotechnology. In March 2022, USDA announced $68 million through the Agriculture and Food Research Initiative to train the next generation of research and education professionals.
     
  • Drive regulatory innovation to increase access to products of biotechnology: The Food and Drug Administration (FDA) is spearheading efforts to support advanced manufacturing through regulatory science, technical guidance, and increased engagement with industry seeking to leverage these emerging technologies. For agricultural biotechnologies, USDA is building new regulatory processes to promote safe innovation in agriculture and alternative foods, allowing USDA to review more diverse products.
     
  • Advance measurements and standards for the bioeconomy: DOC plans to invest an additional $14 million next year at the National Institute of Standards and Technology for biotechnology research programs to develop measurement technologies, standards, and data for the U.S. bioeconomy.
     
  • Reduce risk through investing in biosecurity innovations: DOE’s National Nuclear Security Administration plans to initiate a new $20 million bioassurance program that will advance U.S. capabilities to anticipate, assess, detect, and mitigate biotechnology and biomanufacturing risks, and will integrate biosecurity into biotechnology development.
     
  • Facilitate data sharing to advance the bioeconomy: Through the Cancer Moonshot, NIH is expanding the Cancer Research Data Ecosystem, a national data infrastructure that encourages data sharing to support cancer care for individual patients and enables discovery of new treatments. USDA is working with NIH to ensure that data on persistent poverty can be integrated with cancer surveillance. NSF recently announced a competition for a new $20 million biosciences data center to increase our understanding of living systems at small scales, which will produce new biotechnology designs to make products in agriculture, medicine and health, and materials.

A recording of the White House summit is available online.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 12, 2022, President Joseph Biden signed an Executive Order 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 September 14, 2022, the White House will host a Summit on the National Biotechnology and Biomanufacturing Initiative during which cabinet agencies will announce a wide range of new investments and resources that will allow the United States to harness the full potential of biotechnology and biomanufacturing and advance the President’s Executive Order.
 
According to a White House fact sheet, the initiative will accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. It will “drive advances in biomanufacturing that substitute fragile supply chains from abroad with strong chains at home, anchored by well-paying jobs in communities all across America.” It will improve food and energy security, and promote agricultural innovation while mitigating the impacts of climate change.
 
Specifically, the initiative will:

  • Grow Domestic Biomanufacturing Capacity: The initiative will build, revitalize, and secure national infrastructure for biomanufacturing across America, including through investments in regional innovation and enhanced bio-education, while strengthening the U.S. supply chain that produces domestic fuels, chemicals, and materials.
     
  • Expand Market Opportunities for Biobased Products: The fact sheet notes that the U.S. Department of Agriculture’s (USDA) BioPreferred Program “is the standard for sustainable procurement by government agencies, both providing an alternative to petroleum-based products and supporting good-paying jobs for American workers.” The initiative will increase mandatory biobased purchasing by federal agencies and ensure that the Office of Management and Budget (OMB) and USDA regularly publish progress assessments. The fact sheet states that doing so “will provide specific directions to industry about gaps in biobased product options, leading to the creation of new products and new markets.” Together, the initiative will grow and strengthen the BioPreferred Program, increase the use of renewable agricultural materials, and “position American companies to continue to lead the world in bio-innovation.”
     
  • Drive Research and Development (R&D) to Solve Our Greatest Challenges: According to the fact sheet, focused government support for biotechnology can quickly produce solutions, “as seen with the first-of-their-kind mRNA vaccines during the COVID-19 pandemic.” This initiative directs federal agencies to identify priority R&D needs to translate bioscience and biotechnology discoveries into medical breakthroughs, climate change solutions, food and agricultural innovation, and stronger U.S. supply chains.
     
  • Improve Access to Quality Federal Data: Combining biotechnology with massive computing power and artificial intelligence can produce significant breakthroughs for health, energy, agriculture, and the environment. The Data for the Bioeconomy Initiative will ensure that biotechnology developers have streamlined access to high-quality, secure, and wide-ranging biological data sets that can drive solutions to urgent societal and global problems.
     
  • Train a Diverse Skilled Workforce: The United States is facing a shortage of relevant talent spanning all levels, from community college to graduate school. The initiative will expand training and education opportunities for all Americans in biotechnology and biomanufacturing, with a focus on advancing racial and gender equity and support for talent development in underserved communities.
     
  • Streamline Regulations for Products of Biotechnology: Advances in biotechnology are rapidly altering the agricultural, industrial, technological, and medical products landscape, which can create challenges for developers and innovators. The initiative will improve the clarity and efficiency of the regulatory process for products of biotechnology so that valuable inventions and products can come to market faster without sacrificing safety.
     
  • Advance Biosafety and Biosecurity to Reduce Risk: The initiative will prioritize investments in applied biosafety research and incentivize innovations in biosecurity to reduce risk throughout the biotechnology R&D lifecycles.
     
  • Protect the U.S. Biotechnology Ecosystem: The initiative will protect the U.S. biotechnology ecosystem by advancing privacy standards and practices for human biological data, cybersecurity practices for biological data, standards development for bio-related software, and mitigation measures for risks posed by foreign adversary involvement in the biomanufacturing supply chain.
     
  • Build a Thriving, Secure Global Bioeconomy with Partners and Allies: According to the fact sheet, the initiative advances international cooperation to leverage biotechnology and biomanufacturing to tackle the most urgent global challenges -- from climate change to health security -- and to work together to ensure that biotechnology product development and use aligns with our shared democratic ethics and values, and that biotechnology breakthroughs benefit all citizens.

The White House has posted a transcript of the press call announcing the Executive Order.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340:

These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS at .(JavaScript must be enabled to view this email address). For questions regarding confirmation requests, contact APHIS at .(JavaScript must be enabled to view this email address).


 

By Lynn L. Bergeson

On May 12, 2021, from 3:30 p.m. to 5:00 p.m. (EDT), the European Commission (EC) Helpdesk will host a webinar on appropriate Intellectual Property (IP) rights for biotechnology inventions.  The 60-minute webinar will provide an overview of:

  • Relevant IP rights;
  • Product development IP context;
  • IP specifics in biotechnology;
  • IP portfolio development; and
  • IP portfolio management.

The webinar is free of charge, but registration is required.  Additional information is available here.


 

By Lynn L. Bergeson

On June 26, 2020, the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member, announced the winners of its 2020 Start-Up Stadium competition. The competition had 30 finalists that were evaluated during BIO Digital in June, by expert judges with backgrounds in investment, entrepreneurship, start-ups, economic development, capital formation, and academia. Five winners were chosen based on their commercially viable cutting-edge technologies and therapeutic solutions. Competition winners will receive:

  • A one-year membership in BIO;
  • Four hours of complimentary legal services;
  • One-hour advisory discussion with two venture capital firms; and
  • A “fast-track” accelerator application and nomination into the final selection phase for up to a $10,000 sequencing grant.

 
 1 2 3 >  Last ›