White House Implements New Regulations for Synthetic DNA Manufacturers
In response to the successful synthesis of horsepox virus using commercially available DNA, the White House has introduced new guidelines for companies producing synthetic DNA. The concern is that a similar approach could potentially be used to recreate smallpox, a lethal disease that was declared eradicated in 1980.
Key Points of the New Rules
- DNA manufacturers are required to screen purchase orders for sequences of concern and verify customer legitimacy.
- Sequences of concern are those that contribute to an organism’s toxicity or ability to cause disease.
- Currently, the rules only apply to scientists or companies receiving federal funding, who must order synthetic nucleic acids from providers implementing these screening practices.
Industry Response and Voluntary Measures
Many DNA providers have already been following screening guidelines issued by the Department of Health and Human Services in 2010. Approximately 80 percent of the industry has joined the International Gene Synthesis Consortium, pledging to vet orders. However, these measures are voluntary, and not all companies comply.
While the industry has done a pretty good job of putting some protocols in place, it’s by and large not consistent.
Kevin Flyangolts, founder and CEO of Aclid, a company offering screening software to DNA providers, hopes that Congress will adopt formal legislation requiring all DNA providers to screen orders.
Twist Bioscience’s Proactive Approach
Twist Bioscience, a San Francisco-based DNA-synthesis company, has been screening sequences and customers since 2016. CEO Emily Leproust acknowledges the dual-use nature of DNA technology and the collective responsibility to promote its ethical use.
We recognize that DNA is dual-use technology. It’s like dynamite, you can build tunnels, but you can also kill people.
Twist hired outside consultants to test its screening processes, which helped the company adopt new protocols, such as screening sequences as short as 50 base pairs to prevent customers from assembling smaller sequences together.
Potential Risks and Concerns
Despite the new regulations and voluntary measures, there are still potential risks. Leproust expresses concern about the possibility of a state actor with malicious intentions developing its own DNA synthesis capabilities, as they would have vast resources at their disposal.
Last year, a bipartisan group of legislators introduced the Securing Gene Synthesis Act to mandate screening more broadly, but the bill has yet to advance.
5 Comments
Did they just realize DNA can be synthetic, or are they late to their own party?
So, now even our synthetic strands are under surveillance; talk about privacy invasion!
Big Government stepping into the lab now, because apparently they haven’t had enough of our business yet!
Looks like Big Brother’s watching our genes too, huh?
Wonder how many DNA strands it took for the government to finally decide to step in!