Your input needed on rethinking US regulation


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With little fanfare back in the summer, the US Science and Technology Policy Office (OSTP) issued a request for information (RFI) on the need to update the US oversight of biotech products. The last time the Coordinated Framework for the Regulation of Biotechnology (51 FR 23302; June 26, 1986) was updated was in 1992 when technology, to put it mildly, looked a little different.


There have been one or two fundamental advances in bioengineering technology since that time as well, not least RNAi and CRISPR-Cas9. The OSTP’s RFI solicits input on potential inefficiencies/gaps in the Coordinate Framework overseen by the three major agencies—the US Environmental Protection Agency (EPA), the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA). It is hoped that this consultation process will lead to more streamlined regulation and ensure that the federal biotech regulatory system is prepared for the biotech products of the 21st century.

To accomplish this, a Biotechnology Working Group will be set up to develop an overarching strategy. This will gather feedback from the community and commission an external, independent report to identify both new risks arising from biotechnologies and areas where risks are well understood. The first meeting describing this happened last weekNature Biotechnology encourages its readers to post comments on the White House site. Readers interested in doing so should be aware of the deadline of November 15.

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Life Sciences > Biological Sciences > Biotechnology