On September 12, 2022, United States President Joseph Biden issued an Executive Order connected Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.
The Executive Order referenced lessons learned from the COVID-19 pandemic astir the “vital role” that biotechnology and biomanufacturing played successful “developing and producing life-saving diagnostics, therapeutics, and vaccines” to support Americans and the world. The Executive Order acceptable distant argumentation goals to usage biotechnology successful a assortment of areas, including health, clime change, energy, nutrient security, agriculture, proviso concatenation resilience, and nationalist and economical security.
Specifically, the Executive Order directs assorted branches of the national authorities to bash the following:
- Invest successful and coordinate probe and improvement successful biotechnology and biomanufacturing
- Foster a unafraid and ethical “biological information ecosystem”
- Improve upon and grow accumulation capableness portion accelerating translation of basal probe to commercialized products
- Increase biomass accumulation and “climate smart” inducement for agriculture
- Clarify and streamline regulations and marque biologic hazard absorption a “cornerstone” of biotechnology and biomanufacturing R&D
- Promote standards and found metrics to pass policy, decision-making, and investment
- Develop approaches for hazard and menace appraisal successful concern with backstage industry
- Engage with different countries to heighten cooperation.
Within 180 days of the Executive Order, the Secretaries of Health and Human Services, Energy, Agriculture, Commerce, arsenic good arsenic the Director of the National Science Foundation, volition each taxable a report. Specifically, the Secretary of Health and Human Services volition measure however to usage biotechnology and biomanufacturing to execute aesculapian breakthroughs, trim the wide load of disease, and amended wellness outcomes; the Department of Energy study volition measure however to usage biotechnology, biomanufacturing, bioenergy, and biobased products to code the causes and accommodate to/mitigate the impacts of clime change; the Department of Agriculture volition reappraisal however to usage biotechnology and biomanufacturing for nutrient and agriculture innovation, expanding nutrient prime and nutrition, expanding and protecting cultivation yields, protecting against works and carnal pests and diseases, and cultivating alternate nutrient sources; the Department of Commerce volition study connected however to usage biotechnology and biomanufacturing to fortify the resilience of United States proviso chains.
Within 90 days of the Executive Order, the Office of Management and Budget volition beryllium liable for providing a fund the identifies the existent levels of bureau spending to assistance pass the improvement of the implementation plan. After receiving the reports, the Director of the Office of Science and Technology Policy, coordinating with due agencies, volition make an implementation program for the recommendations. The agencies and functionalities that are identified arsenic being liable for the implementing actions volition request to study connected the measures taken and resources allocated to heighten biotechnology and biomanufacturing wrong 2 years of the Executive Order.
Government Agency Response
Two days aft the Executive Order was signed, the Department of Health and Human Services issued a property release covering immoderate of the actions the section plans to instrumentality successful response. According to the release, “HHS intends to leverage biotechnology and biomanufacturing successful bid to execute aesculapian breakthroughs, trim the wide load of disease, and amended wellness outcomes.” One enactment (among many) that HHS intends to instrumentality is to enactment the improvement of Food and Drug Administration (FDA) probe programs for precocious manufacturing technologies, successful the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), fueling aggregate intramural and extramural probe projects to physique a cognition basal successful enactment of regulatory assessment, arsenic good arsenic technological standard, guidance, and argumentation development.
The Department of Defense also released a statement astir its absorption pursuing the Executive Order, including the announcement of $1.2 cardinal successful caller investments successful biomanufacturing (broken down into $1 cardinal successful bioindustrial home manufacturing infrastructure and $200 cardinal to enactment enhancements to biosecurity and cybersecurity).
BIO Response
Dr. Michelle McMurry-Heath, president & CEO of the Biotechnology Innovation Organization (BIO), released the pursuing statement successful effect to the Executive Order, “BIO welcomes the Biden Administration’s directives to fortify our home biotechnology and biomanufacturing industry. This Executive Order the president signed contiguous acknowledges the ‘power of biotechnology’ and its benefits to the U.S. economy, enactment unit and prime of life, arsenic good its imaginable to boost nutrient and agriculture innovation and code the clime crisis. We commend the medication for launching this initiative, peculiarly the actions to streamline regulatory regulations for biotechnology products, grow marketplace opportunities for biobased products, enactment for planetary alignment of regulatory standards, and put successful grooming and acquisition pathways to guarantee an adequate, divers biotech workforce.”
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