Synthetic Biology Faces Difficult Regulatory Environment for Startups

The pathway to market for new products utilizing synthetic biology can be difficult to navigate, posing a challenge for companies in their efforts to commercialize new ideas, while the novelty posed by some of these products can make it difficult for regulatory agencies to evaluate risks, according to a new report from the Synthetic Biology Project.

The report, The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?, explores current government oversight of synthetic biology in the United States by examining the regulatory pathways of different products and applications. The case studies in the report include synthetic organisms, synthetic chemicals, biopesticides, biomining products, and genetically modified plants, which are regulated by the Environmental Protection Agency, Food and Drug Administration and U.S. Department of Agriculture.

This regulatory environment can be particularly challenging for startups in the biotechnology space. While larger companies may have the resources to navigate the various laws, it can be difficult for smaller companies to know which agency to approach and even which laws may apply to particular applications.

"Based on this report, it appears the U.S. regulatory system may need its own genetic engineering," says Dr. Todd Kuiken, senior program associate with the Synthetic Biology Project. "The system is not flexible enough to address rapidly evolving technologies like synthetic biology. This could make it difficult for agencies to properly evaluate the potential risks of these products, as well making it difficult for products to move to the market."

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