Failures and Risks in Biosafety Regulation

Posted by Pete Shanks on July 24th, 2014

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The Centers for Disease Control and Prevention (CDC) suffered real embarrassment the other week, and we are all very fortunate that the consequences were not worse. Dozens of employees "were potentially exposed to deadly anthrax spores" (though no one got sick) and a lethal strain of flu virus accidentally contaminated a much milder sample that was distributed to a Department of Agriculture labMeanwhile, six 60-year-old vials of smallpox virus were found in an old refrigerator at NIH, two of which contained live specimens.

As Laurie Garrett eloquently put it: Oops. Her must-read piece in Foreign Policy was titled:

It’s 10 o'Clock — Do You Know Where Your Bubonic Plague Is?
Spilled smallpox, missing SARS, and rogue scientists with mutant H1N1. If you’re not scared, you should be.

The "missing SARS" refers to an incident in France last year; not CDC, but certainly fitting the pattern. The agency’s head, Thomas R. Frieden, was appropriately “stunned and appalled” by the recent incidents (especially since no one had even told him immediately about the flu error). We can assume that, even if heads don’t roll, procedures will be tightened and many presumably sensible changes will be made. As The New York Times noted solemnly in an editorial:

A small careless error in these experiments could be devastating.

These revelations provide the context for an unusual proposal of caution and public consultation made by a number of very prominent scientists last week. A group of researchers has proposed that policymakers and the public carefully consider the consequences before the introduction of a new practice known as "gene drives," which could lead to "addressing ecological problems by altering entire populations of wild organisms."

The way this might happen is by making very specific changes (using Crispr technology) to the genome of a sexually reproducing organism. These will create truly “selfish” genes — their frequency in a population will increase, even though they are less likely to reproduce. The engineered genes “drive” themselves through the population, possibly even driving the population to extinction. This sounds strange, but it was proposed in theory by Austin Burt in 2003, and technology is now catching up.

There is a peer-reviewed article in eLife by Kevin Esvelt, Andrea Smidler, Flaminia Catteruccia & George Church that gives a 39-page overview of the rapidly developing science. It is accompanied in Science Express by a three-page "discussion of risk governance and regulation intended specifically for policymakers.” The principal contributors to that are Kenneth Oye and Kevin Esvelt, who are joined by eight others (including all the eLife co-authors). Useful summaries can be found in the Boston GlobeMIT Technology ReviewScience Insider and MIT News.

They are of course quite right. These potentially huge environmental interventions deserve broad and careful consideration. And we do not have an adequate regulatory structure, nor a robust political or cultural tradition, nationally or internationally, to handle the novel questions involved.

The first application of this kind of approach seems likely to be on mosquitoes. But that is already well under way, albeit with older technology, making this more than a little misleading:

A Call to Fight Malaria One Mosquito at a Time by Altering DNA

That’s the headline The New York Times gave Carl Zimmer’s story. But in fact Oxitec, a British company that is not mentioned in either of last week’s scientific papers, has been working on modifying mosquitoes for yearsThe New Yorker had a feature on them in 2012. Oxitec focuses on dengue fever, which the US scientists mentioned, but perhaps that's less dramatic for whipping up public support than malaria. (Genewatch UK has much more on Oxitec and GM insects here.)

What the emphasis on mosquitoes does indirectly show is the scarcity of obviously appealing goals for using such an intrusive and potentially overwhelming technology. Sure, everyone can get behind eliminating malaria and dengue fever. And some people might like to rid the Great Lakes of invasive carp. No one likes rats, which as an invasive species are said to cause $19 billion in damage every year. And there is talk about reversing the evolution of plants that have become resistant to herbicides. 

All this suggests is that gene drives are part of a potentially very powerful technology whose application is as yet not entirely clear. The scientists involved deserve to be commended for raising the issue of appropriate regulation, and we should note that one of the safety proposals is a plan to reverse such interventions should there develop a problem. But the principal lesson of the recent CDC failures is surely that human error will always find a way through.

Besides, haven’t they heard of kudzu?

Previously on Biopolitical Times:

Posted in Animal Technologies, Bioethics, Biopolitics, Parties & Pundits, Biotech & Pharma, Environmentalism, Global Governance, Inheritable Genetic Modification, Medical Gene Transfer, Pete Shanks's Blog Posts, Synthetic Biology, US Federal


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