On September 12, 2022, President Biden issued an “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” This “National Biotechnology and Biomanufacturing Initiative” seeks to advance U.S. biotechnology and biomanufacturing to offer revolutionary options in “health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.”
Some of its targets are to extend biomanufacturing capability within the U.S. (hopefully resulting in decrease drug costs), increase biomass manufacturing (which is renewable or recurring organic supplies reminiscent of plant and tree materials and animal and meals waste), and educate the following era of scientists and engineers in bioeconomy disciplines. While a lot of the Executive Order stresses well being, medication, vitality and organic knowledge, there are particular sections that apply to agriculture and meals. Here are my observations about these particular sections.
Useful Information Will Be Generated that Can Inform Federal Policy
The Executive Order provides the Secretary of Agriculture 180 days to submit a report on how biotechnology and biomanufacturing can be utilized for meals and agricultural innovation. If USDA carries out an intensive investigation, the report may very well be roadmap figuring out the potential of biotechnology merchandise to enhance sustainability, assist agriculture adapt to and mitigate the results of local weather change, improve meals high quality and dietary content material, and produce various meals sources.
At the identical time, the Director of OMB is required to establish present ranges of USDA spending on biotechnology and biomanufacturing-related actions. An in depth price range stock on what completely different businesses and workplaces in USDA are investing on biotechnology, particularly if damaged down into classes reminiscent of primary analysis, product improvement, and danger evaluation and administration, would enable policymakers to find out whether or not the general public funding in biotechnology is enough to attain the potential that can be set out within the Secretary’s report.
FDA’s Role within the Food Supply and Biotechnology Innovation is Not Explicitly Acknowledged
While USDA is the recognized lead for meals and agriculture, the Department of Health and Human Services can be talked about a number of occasions within the Executive Order and is designated the lead for well being and medication. The Food and Drug Administration is simply talked about as soon as, when discussing the necessity for bettering the readability and effectivity of the regulatory course of for biotechnology merchandise. FDA performs necessary roles in lots of meals areas, together with revolutionary meals merchandise (e.g., cell-cultured meat and new fermentation elements), vitamin, meals labeling, and aquaculture. FDA ought to be a co-lead with USDA on all meals biotechnology points.
Instead, the Executive Order duties the Secretary of Agriculture with consulting with applicable businesses on all meals and agricultural innovation. It can be important that USDA not solely engages with FDA however contains FDA’s experience and perspective, which typically is completely different from positions taken by USDA. The identical may very well be mentioned for the Environmental Protection Agency (EPA), which is concerned with quite a few bioeconomy merchandise (e.g., biopesticides and nitrogen fixing microorganisms) that have an effect on agriculture and the surroundings.
The Regulation Section — We Have Read the Same Before
The Executive Order is right when it states that “the complexity of the current regulatory system for biotechnology products can be confusing and create challenges for businesses to navigate” (in addition to for stakeholders and shoppers to know). A really related assertion may be discovered within the Executive Order Issued by President Trump in 2019 and earlier authorities paperwork.
The Executive Order requires USDA, EPA, and FDA to establish “areas of ambiguity, gaps, and uncertainties” and then present a plan for regulatory reform. For these of us who’ve studied the U.S. regulatory system, the “ambiguities, gaps, and uncertainties” have been well-known for years and come up from the regulation of latest and novel merchandise utilizing statutes that by no means envisioned such merchandise (i.e., like becoming a sq. peg right into a spherical gap).
The Executive Order additionally stresses the necessity to “take concrete steps to reduce biological risks associated with advances in biotechnology” and to put money into biosafety and biosecurity. The query can be how the Biden Administration balances these two mandates. How will it guarantee the security of biotechnology merchandise (which is important for shopper confidence and acceptance) whereas setting up a regulatory system that’s science-based, proportionate, clear, and participatory.
While the federal authorities works on regulatory reform (which everyone knows is a protracted course of), the Executive Order does establish some short-term actions that may very well be very useful. These embody offering the general public with “plain language information regarding the regulatory roles, responsibilities and process of each agency” and case research on which businesses regulate completely different novel biotechnology merchandise. The Order additionally envisions a unified web site the place inquiries a few explicit product may be submitted, and submitters would obtain a coordinated federal response.
Overall, the Executive Order highlights the worth of the bioeconomy and the necessity for a coordinated coverage and implementation plan to make sure the United States stays a pacesetter on this space. However, as is at all times the case, the satan is within the particulars and these particulars will decide whether or not this initiative’s final impression is optimistic, unfavorable, or impartial.
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