Background

A new Biden administration initiative will seek to strengthen U.S. biotechnology supply chains, including by reducing reliance on foreign suppliers in a field seen as increasingly relevant to a wide range of industries.

In a Sept. 12 executive order, President Biden said that global industry “is on the cusp of an industrial revolution powered by biotechnology,” which could account for more than a third of global manufacturing output by the end of the 2020s and will influence production of everything from medicines to fuels to plastics. However, he added that the U.S. has relied too heavily on foreign materials and production in the biotechnology field and that “our past off-shoring of critical industries … threatens our ability to access materials like important chemicals and active pharmaceutical ingredients.”

In response, the EO launches a National Biotechnology and Biomanufacturing Initiative that seeks to strengthen U.S. biotechnology supply chains and prevent disruptions, including through what a senior administration official called “bio-based production of active pharmaceutical ingredients, biomanufacturing facilities that do not rely on foreign suppliers, and biomining of rare earth elements.” The initiative also aims to aid climate change efforts by “replacing foreign petrochemicals with locally produced bio-based chemicals.”

According to a White House fact sheet, objectives of the new initiative include the following.
- build, revitalize, and secure national infrastructure for biomanufacturing while strengthening the U.S. supply chain that produces domestic fuels, chemicals, and materials (e.g., the Department of Defense will invest $1 billion over five years to expand manufacturing capacity for products important to both commercial and defense supply chains)

- identify priority research and development needs to translate bioscience and biotechnology discoveries into medical breakthroughs, climate change solutions, food and agricultural innovation, and stronger U.S. supply chains

- 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

- increase mandatory bio-based purchasing by federal agencies through the BioPreferred Program and regularly publish assessments of progress

- 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 in health, energy, agriculture, and the environment

- 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

- expand domestic training and education opportunities in biotechnology and biomanufacturing

- advance international cooperation to tackle global challenges and ensure that biotechnology product development and use aligns with democratic ethics and values

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