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Posted on September 13, 2022 by Lynn L BergesonBy 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.
Posted on February 24, 2017 by Kathleen M RobertsOn February 13, 2017, seven democratic Senators sent a letter to White House Counsel Don McGahn requesting details on Carl Icahn’s role in the Trump Administration and the extent of his influence over the Renewable Fuel Standard (RFS) program. On December 21, 2016, it was announced that Mr. Icahn would serve the Trump Administration as a special advisor for overhauling federal regulations. The Senators’ letter highlights concerns over Icahn’s public statements regarding RFS obligations and his role as chairman of the board and majority shareholder of Icahn Enterprises. The Senators noted that, as of September 30, 2016, Icahn Enterprises owned an 82 percent stake in CVR Energy, which is an oil refiner required to meet the RFS obligations. The letter requests that McGahn provide answers to a number of questions regarding Icahn, including whether:
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He is a federal employee;
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He has access to confidential information;
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He provided financial disclosures to the Administration;
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He is barred from providing advice on any regulations;
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He provided advice to President Trump on any Senate-confirmed or schedule C appointees;
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The Administration believes he is subject to any laws or regulations governing conflicts of interest;
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He has recused himself from any decisions or discussions that may present a conflict of interest; and
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He is required to divest from any of his holdings. |
Posted on January 13, 2017 by Lynn L BergesonOn January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” More information is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology.
Posted on January 05, 2017 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update). The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the Update to the Coordinated Framework offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” To help product developers and the public understand what the regulatory pathway for products might look like, the 2017 Update presents information about agency roles and responsibilities in several forms, including:
- Graphics that illustrate agency-specific overviews of regulatory roles;
- Case studies that demonstrate how a product developer might navigate the regulatory framework; and
- A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.
In its blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System,” the Obama Administration acknowledges that while the 2017 Update represents “remarkable progress by the EPA, FDA, and USDA to modernize the regulatory system for biotechnology products, much work remains.” EPA, FDA, and USDA will consider the comments submitted in response to the proposed 2017 Update and information gathered during the three public engagement sessions hosted by EPA, FDA, and USDA to inform ongoing and future agency activities. In addition, the agencies commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products. When completed, the agencies will consider the study’s findings, as well as the comments. More information on the Update to the Coordinated Framework will be available in our forthcoming memorandum, which will be available on our website under the key phrase biobased products, biotechnology.
Posted on July 18, 2014 by Heidi
On July 15, 2014, Inside EPA reported that "the White House is examining options for reversing EPA's proposed cuts to several renewable fuel standard (RFS) production targets in order to promote biofuels that create fewer greenhouse gases (GHGs) than conventional fuels, informed sources say, as part of the Obama administration's broader efforts to combat climate change."
The article also quotes sources stating:
"[F]igures under discussion between administration officials and industry representatives include raising the renewable fuel target -- largely met with corn ethanol production -- from 13 billion gallons in the proposed rule to a range of 13.5-13.6 billion gallons in the final rule; increasing the advanced biofuel target from 2.2 billion gallons in the proposed rule to a range of 2.3-2.5 billion gallons; and raising the biomass-based diesel target from 1.28 billion gallons under the proposed rule to 1.5-1.7 billion gallons in the final rule.
"The most dramatic increase under consideration is said to be for cellulosic biofuel, which would rise from 17 million gallons in the proposed rule to 23 million gallons in the final rule, the sources say. "
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