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 July 26, 2022, Senators Chuck Grassley (R-IA) and Joni Ernst (R-IA) introduced the bipartisan and bicameral Next Generation Fuels Act (S. 4621), which would aim to leverage higher-octane fuels to improve engine efficiency and performance. According to Grassley’s July 26, 2022, press release, allowing the sale of fuels with greater octane levels would increase the amount of ethanol that can be used in the fuel supply, in turn lowering prices at the pump for consumers. The press release states that due to ethanol’s high-octane rating, greater ethanol blends result in both additional fuel efficiency and significant greenhouse gas (GHG) reduction. Ethanol is also priced lower than gasoline, making it the most cost-effective octane source. Under the bill, the U.S. Environmental Protection Agency (EPA) would be required to carry out a study of the emissions effects of ethanol-blended fuels in light-duty vehicles and light-duty trucks, for the purpose of updating the Motor Vehicle Emission Simulator modeling system. The bill would establish a minimum research octane number (RON) standard of 98 for gasoline, which is higher than the typical octane rating of 91 RON today. It would also require sources of the added octane value to reduce carbon emissions by at least 40 percent compared to baseline gasoline. The bill was referred to the Senate Committee on Finance.
Bergeson & Campbell, P.C.’s (B&C®) May 18, 2022, webinar “Domestic Chemical Regulation and Achieving Circularity” is now available for on-demand viewing. During this one-hour webinar, Lynn L. Bergeson, Managing Partner, B&C, moderated a timely and fascinating review of the state of sustainable chemical regulation in the United States with Kate Sellers, Technical Fellow, ERM; Mathy Stanislaus, Vice Provost, Executive Director, The Environmental Collaboratory, Drexel University; and Richard E. Engler, Ph.D., Director of Chemistry, B&C.
A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful lives. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. During the webinar, Ms. Sellers outlined barriers and enablers to the circular economy, including practical challenges like supply chain limitations and industry frameworks; Dr. Engler highlighted how the Toxic Substances Control Act (TSCA) regulates discarded substances used as feedstocks by others and articles that may contain contaminants that could affect how an article is classified by the U.S. Environmental Protection Agency (EPA) under TSCA; and Mr. Stanislaus reviewed policy issues, including waste management hierarchy, circular economy hierarchy, and other mechanisms that incentivize sustainability.
We encourage you to view the webinar, listen to the All Things Chemical® episodes “Trends in Product Sustainability and Circularity — A Conversation with Kate Sellers” and “How Can Battery Production Be Greener? — A Conversation with Mathy Stanislaus,” read ERM’s report Circularity: From Theory to Practice, and subscribe to B&C’s informative blogs and newsletters.
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On April 12, 2022, U.S. Department of Agriculture’s (USDA) Tom Vilsack, Agriculture Secretary, announced steps that USDA is taking to implement President Biden’s plan to enable energy independence by boosting homegrown biofuels. President Biden’s plan aims to reduce energy prices and tackle the rising consumer prices caused by “Putin’s Price Hike.” As part of USDA’s measures to help the Biden Administration to achieve its goals, USDA is making the following investments:
- $5.6 million in funding for seven states to build infrastructure for renewable fuels through the Higher Blends Infrastructure Incentive Program;
- $700 million for biofuels producers through USDA’s new Biofuel Producer Program;
- $100 million for biofuels infrastructure grants; and
- Billions of dollars to support a new market in sustainable aviation fuels by partnering with the federal government to advance the use of cleaner and more sustainable fuels in the United States.
According to USDA, these investments will assist in the development, transportation, and distribution of low-carbon fuels, more affordable and cleaner fuels for consumers, and better market access for producers.
By Lynn L. Bergeson
The Senate Committee on Environment and Public Works held a hearing on April 6, 2022, on the U.S. Environmental Protection Agency’s (EPA) proposed fiscal year (FY) 2023 budget. The only witness was EPA Administrator Michael S. Regan. In his written testimony, Regan states that EPA has significant responsibilities under amendments to the Toxic Substances Control Act (TSCA) to ensure the safety of chemicals in or entering commerce and addressing unreasonable risks to human health or the environment. President Biden’s proposed budget would provide $124 million and 449 full-time equivalents (FTE) to implement TSCA, an increase of more than $60 million. According to Regan, these resources will support EPA-initiated chemical risk evaluations, issue protective regulations in accordance with statutory timelines, and establish a pipeline of priority chemicals for risk evaluation. EPA “also has significant responsibility under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to screen new pesticides before they reach the market and ensure pesticides already in commerce are safe.” Regan notes that in addition, EPA is responsible for complying with the Endangered Species Act (ESA) and ensuring that federally endangered and threatened species are not harmed when EPA registers pesticides. The FY 2023 budget includes an additional $4.9 million to enable EPA’s pesticide program to integrate ESA requirements in conducting risk assessments and making risk management decisions that protect federally threatened and endangered species from exposure to new active ingredients.
After Regan gave his opening statement, the Committee asked questions. Committee Chair Tom Carper (D-DE) stated that President Biden requested $124 million and hiring of about 450 FTEs to implement the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). According to Carper, despite the previous Administration’s failure to request funds to support implementation of the Lautenberg Act, EPA professionals have worked hard to meet the aspirations and mandates of the Act. Carper asked Regan to describe the resource challenges that the TSCA program is currently facing and how EPA plans to fulfill its obligations under the Lautenberg Act if Congress appropriates the increase in resources requested by the Biden Administration. Regan stated that the previous Administration missed nine of ten deadlines for chemical risk review evaluations. Meanwhile, the workload for the Biden EPA has doubled, with 20 high-priority risk evaluations to do and ten risk management rules to write, but EPA is still working with the same budget that it had before the Lautenberg Act. As a result, EPA has only about 50 percent of the resources that it thinks it needs to review the safety of new chemicals quickly and in the way that the law requires. The proposed FY 2023 budget reflects what EPA thinks it will actually take to implement the Lautenberg Act in the way that Congress and stakeholders expect and deserve. According to Regan, EPA would put those resources to good use. EPA wants to keep pace with what Congress requested.
According to Senator Kevin Cramer (R-ND), the North Dakota Agricultural Commissioner sent a letter to EPA’s Office of Pesticide Programs (OPP) (still waiting for a response) about unused stocks of chlorpyrifos. In August 2021, EPA issued a final rule revoking all tolerances for chlorpyrifos. Cramer stated that under the final rule, farmers and retailers have six months to dispose of it. To date, there has been very little to no guidance on how to dispose of it, and without guidance from EPA, there is worry about improper disposal or illegal use. Cramer asked Regan if he could provide some assurance that EPA is not going to seek to punish growers that currently have product in their possession. Regan responded that in this case, like others, EPA found itself in a situation where, because of inaction over decades, the court put it on a timeline to take action. Regan stated that he can commit that the EPA regional office is working with North Dakota now to think about how to address the situation.
As Regan noted in his testimony before the Committee, the Lautenberg Act includes statutory deadlines that EPA must meet as it evaluates existing chemicals. In addition to these mandates, after reviewing the risk evaluations completed by the previous Administration, the Biden EPA announced June 30, 2021, its plans to review and address certain issues. The Biden EPA is working to complete its revisions to the final risk evaluations and move to the risk management rulemaking stage. Under the previous Administration, EPA, in 2020 and 2021, directed significant energy to developing risk evaluations for the “Next 20” chemicals designated as high priority for risk evaluations through the TSCA prioritization process, completing scoping documents in September 2020. In light of the Biden Administration’s revised approach to risk evaluations, however, those scoping documents will need to be revisited and revised as appropriate, and work is expected to continue through 2022 and probably much of 2023. EPA also now has received four manufacturer-requested risk evaluations, three of which have been granted as of mid-December 2021, and one of which is pending. Without significant resources, the Biden EPA will struggle to meet the ambitious goals of the Lautenberg Act.
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On March 9, 2022, U.S. Senators Joni Ernst (R-IA) and Amy Klobuchar (D-MN) introduced the Home Front Energy Independence Act that would ban Russian oil and replace it with the use of biofuels produced in the United States. This bill combines parts of past bills that would make ethanol 15 (E15) available year-round, establish an E15 and Biodiesel Tax Credit, direct the U.S. Environmental Protection Agency (EPA) to finalize the E15 labeling rule, and provide biofuel infrastructure and compatibility with retailers:
Several Senators co-sponsored the bill, including Tammy Baldwin (D-WI), Tammy Duckworth (D-IL), Deb Fischer (R-NE), Chuck Grassley (R-IA), and Roger Marshall (R-KS0. Senator Klobuchar stated that this bill will help to hold Vladmir Putin accountable for Russia’s invasion of Ukraine, while also investing in affordable, readily available biofuels produce in the United States.
By Lynn L. Bergeson
The Office of Science and Technology Policy (OSTP) published on April 4, 2022, a request for information (RFI) from interested parties on federal programs and activities in support of sustainable chemistry. 87 Fed. Reg. 19539. OSTP notes that “[t]he term “sustainable chemistry” does not have a consensus definition and most uses of the term indicate that it is synonymous with “green chemistry.”” OSTP requests information on the preferred definition for sustainable chemistry. OSTP also seeks comments on how the definition of sustainable chemistry could impact the role of technology, federal policies that may aid or hinder sustainable chemistry initiatives, future research to advance sustainable chemistry, financial and economic considerations, and federal agency efforts. OSTP states that it will use comments provided in response to the RFI to address Subtitle E of Title II of the National Defense Authorization Act (NDAA) (Subtitle E), which includes the text of the bipartisan Sustainable Chemistry Research and Development Act of 2019. Subtitle E directs OSTP “to identify research questions and priorities to promote transformational progress in improving the sustainability of the chemical sciences.” Comments are due by 5:00 p.m. (EDT) on June 3, 2022. Additional Information is available in the B&C’s April 6, 2022, memorandum.
By Lynn L. Bergeson and Carla N. Hutton
On March 16, 2022, the House Science, Space, and Technology Subcommittee on Energy will hold a hearing on “Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.” According to the hearing charter, the purpose of the hearing is to examine the status of bioenergy research, development, and demonstration (RD&D) activities carried out by the U.S. Department of Energy (DOE). The hearing will also consider advancements in bioenergy research and the potential role of this resource in a cleaner energy transition. Lastly, the hearing will help inform future legislation to support and guide the United States’ bioenergy RD&D enterprise. Witnesses will include:
- Dr. Jonathan Male, Chief Scientist for Energy Processes and Materials, Pacific Northwest National Laboratory (PNNL);
- Dr. Andrew Leakey, Director of the Center for Advanced Bioenergy and Bioproducts Innovation at the University of Illinois Urbana-Champaign;
- Dr. Laurel Harmon, Vice President of Government Affairs, LanzaTech; and
- Dr. Eric Hegg, Professor, Biochemistry and Molecular Biology, Michigan State University.
The hearing charter notes that in addition to fuels, biomass can be used to create valuable chemicals and materials, known as “bioproducts.” According to the hearing charter, approximately 16 percent of U.S. crude oil consumption is used to make petrochemicals and products, such as plastics for industrial and consumer goods, fertilizers, and lubricants. Common biobased products include household cleaners, paints and stains, personal care items, plastic bottles and containers, packaging materials, soaps and detergents, lubricants, clothing, and building materials. The hearing charter states that the production of bioproducts relies on much of the same feedstocks, infrastructure, feedstock commoditization, and technologies that are central to biofuels production. Therefore, according to DOE, once technologies are proven for bioproduct applications, they could be readily transferred and greatly improve biofuel production.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, February 23, 2022, from 2:00 to 3:00 p.m. (EST) to learn about requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this effort, it is offering outreach and training to stakeholders interested in biofuels. According to EPA, the bi-weekly webinar series includes reviewing TSCA requirements, outlining the streamlined approaches for risk assessments and risk management actions, and providing information on how to navigate the new chemicals PMN process. Future webinars will include:
Registration is required for the February 23, 2022, webinar.