BIOSECURITYHow Secure Is Gene Synthesizing Research?

Published 8 June 2024

Critics warn that the benefits of gene synthesizing research are undermined by security measures which are not sufficiently tight to prevent such research form being used by bad actors to do harm. One expert writes: “The problem is that governments don’t mandate security across the industry — and even though it’s a crime to ship DNA sufficient to generate the entire infectious 1918 influenza, there’s no law against shipping pieces of it.” The International Gene Synthesis Consortium disagrees.

In an article published in STAT, MIT’s Kevin M. Esvelt wrote about the need for tither security of gene synthesizing research. He writes:

To test the effectiveness of current practices, Rey Edison and Shay Toner, both Ph.D. students in my lab at MIT, conducted a red-teaming experiment overseen by the Federal Bureau of Investigation. They used simple evasive strategies to camouflage orders for gene-length DNA fragments that could be used to generate the 1918 influenza virus, which killed more than 50 million people. The orders were placed on behalf of an organization that doesn’t perform lab experiments and requested shipping to an office address that obviously lacks laboratory space, providing extra reasons for suspicion. Alarmingly, 36 out of 38 providers — including 12 of 13 IGSC members — shipped multiple 1918 influenza fragments. Only one company detected a hazard and requested proof of biosafety approval.

Using complementary DNA pieces for safety, Edison and Toner then showed that standard synthetic biology techniques could assemble harmless constructs equivalent to ones that would generate the infectious virus. In other words, it’s now so easy to assemble fragments of the 1918 influenza genome that a collection of pieces is as dangerous as the entire thing.

This isn’t a criticism of gene synthesis providers, many of whom have been voluntarily screening orders at their own expense. The problem is that governments don’t mandate security across the industry — and even though it’s a crime to ship DNA sufficient to generate the entire infectious 1918 influenza, there’s no law against shipping pieces of it.

Pandora Report writes about the response to by the International Gene Synthesis Consortium (IGSC):

This piece from The Bulletin of the Atomic Scientists was authored by the International Gene Synthesis Consortium (IGSC) in response to a red-teaming evaluation conducted last year by Rey Edison, Shay Toner, and Kevin Esvelt of the Massachusetts Institute of Technology. The piece explains “The recent red-teaming evaluation by Rey Edison, Shay Toner, and Kevin Esvelt incorrectly characterized industry biosecurity screening performance. Specifically, in late 2023, Edison and Toner, graduate students from the Massachusetts Institute of Technology (MIT), working with Esvelt, a professor at the university, ordered short segments of a virus from multiple commercial DNA synthesis companies, including IGSC member companies, to be delivered to a commercial building adjacent to MIT’s campus.”

It continues, “The authors of the evaluation make two major arguments in this report: 1) that DNA synthesis companies ‘missed’ the pathogen sequence in the orders and 2) that ordering pieces of DNA from multiple vendors allowed them to reconstruct a gene from the 1918 influenza virus. Both of these arguments demonstrate a misunderstanding of the government guidance and the state of the art in biosecurity sequence screening to enable safe, responsible research to proceed.”

IGSC member companies screened both the sequence and the customer in accordance with 2023 guidance from the US government. Multiple IGSC member companies detected the ordered sequence and determined the order to be legitimate as defined in the 2023 guidance. Specifically, the orders were placed on behalf of SecureBio, an organization known to IGSC member companies given the role played by SecureBio in the SecureDNA project, an effort to build a DNA synthesis screening system. In addition, the name on the orders was an individual who has co-published multiple times with  Esvelt, an individual well known to IGSC companies to work in viral evolution and who is known to have access to laboratory facilities sufficient to work safely with the ordered material.”

“In short, the system worked as designed: a legitimate individual ordered DNA sequence that, by itself, posed no risk of misuse, for delivery to a company associated with legitimate scientific contributions directly relevant to the sequence that was ordered.”

Read more here.