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Exec. Order Aims to Boost U.S. Biotech, Manufacturing

White House, Lafayette Square

(A. Kotok)

13 Sept. 2022. An executive order issued by President Joe Biden yesterday seeks to make biotechnology and biomanufacturing a centerpiece of the American economy. The order aims to expand biotechnology applications in health, agriculture, and energy, with manufacturing of new bio-based products performed in U.S. factories, as well as more research and development.

The executive order makes advances in biotech a U.S. policy goal, calling for new investments in research and development, biomanufacturing, and biomass production for energy use, while expanding the bio-economy workforce, and boosting safety and security. In addition, the order calls for streamlining regulations, while setting standards and metrics for gauging the state of the bio-based economy. And while the order references engagement with the international community, it also clearly spells out the policies should “support a vibrant domestic biomanufacturing ecosystem.”

The document requires the government’s HHS, Agriculture, and Energy departments to determine how biotechnology can better meet the nation’s health, climate, energy security, and food security goals, and calls for bolstering investments in biotech-related research. Key R&D areas include …

engineering biology; predictive engineering of complex biological systems, including the designing, building, testing, and modeling of entire living cells, cell components, or cellular systems; quantitative and theory-driven multi-disciplinary research to maximize convergence with other enabling technologies; and regulatory science, including the development of new information, criteria, tools, models, and approaches to inform and assist regulatory decision-making.

The order makes clear labs and companies in the U.S. are the beneficiaries of these initiatives. The text calls for Federal agencies in 180 days to …

develop a strategy that identifies policy recommendations to expand domestic biomanufacturing capacity for products spanning the health, energy, agriculture, and industrial sectors, with a focus on advancing equity, improving biomanufacturing processes, and connecting relevant infrastructure. Additionally, this strategy shall identify actions to mitigate risks posed by foreign adversary involvement in the biomanufacturing supply chain and to enhance biosafety, biosecurity, and cybersecurity in new and existing infrastructure.

Driven in part by developments in China

In addition, the document calls the intelligence community to “identify elements of the bioeconomy of highest concern and establish processes to support ongoing threat identification and impact assessments,” as well as provide classified assessments of “foreign adversary means of, and intended usages related to, acquisition of United States biotechnologies, biological data, and proprietary or precompetitive information.”

Reporters from two news organizations attending a background briefing on the order cite Biden administration officials who say the document is a response in part to recent advances in China that has its own national biotech development program. The text of the order does not specifically mention other countries.

The executive order calls for an initiative to boost bio-safety and security to reduce risks to the public as a bio-based economy expands. At the same time, the text asks regulatory agencies — Food and Drug Administration, Department of Agriculture, and Environmental Protection Agency — to identify gaps and ambiguities in regulations, and within one year develop a unified web site for biotech regulations. However, the order makes no mention of changes to patent or other intellectual property laws that often drive biotech investments and development.

The Biotechnology Innovation Organization, the U.S. biotech industry association, largely approves of the order. “This Executive Order the president signed today,” says Michelle McMurry-Heath, the organization’s CEO in a statement, “acknowledges the ‘power of biotechnology’ and its benefits to the U.S. economy, work force and quality of life, as well its potential to boost food and agriculture innovation and address the climate crisis.”

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