As I wrote in a GLP post during the summer we're on the cusp of another wave of biotechnology culture wars. Synthetic biology, which is different from other biotechnology disciplines because it can entail the creation of entirely novel genes and organisms, is poised to move from labs to our lives. I focused on the public relations side of synthetic biology. What about regulations?
Biotech critic Pete Shanks, writing for the Center for Genetics and Society, has raised an interesting question to consider as we reevaluate existing regulations and devise new ones to deal with the oncoming rush of synthetic biology:
How can we ensure that social, economic, ethical and other factors are considered? For too long safety has been very narrowly interpreted, and substantial equivalence far too broadly assumed.
While some biotech applications such as genetically modified foods do undergo stringent "safety" review — GM crops have taken on average six to eight years before they have been approved and AquaBounty's GM salmon has been undergoing regulatory review for more than 12 years now —Shanks's concern about biotechnology is nonetheless a very real one. This is especially important in the United States where public perception can be more important than the science when it comes to policy decisions.
Right now, there is a great deal of public suspicion about our regulatory agencies and processes when it comes to the GM crops and foods. Many anti-GMO activists believe that existing oversight bodies are in the pocket of Monsanto and Big Ag; worse than insufficient, they think existing regulation is corrupt. Synbio, which entails even more dramatic genetic modification, is likely to engender similar suspicions as the public becomes more aware.
Shanks raises concerns partly in response to a new 60-page, federally funded report on synthetic biology regulation called "Synthetic Biology and U.S. Biotechnology Regulatory System: Challenges and Options." GenomeWeb has posted an overview of the report, which argues that existing regulatory systems are, by and large, sufficient to handle synthetic biology:
The three authors from the J. Craig Venter Institute, the University of Virginia, and the European Molecular Biology Organization pointed out in the report that the US Department of Agriculture, the Food and Drug Administration, and the Environmental Protection Agency have already overseen genetically engineered organisms for years.
Ever since the first recombinant DNA-based products began hitting the market in the 1980s, these agencies have been reviewing genetically engineered products for environmental, health, and safety concerns, and have issued regulations and industry guidelines.
Of course the question here isn't whether the USDA, FDA and EPA have been overseeing genetically engineered organisms, but whether or not they've been doing a good job of it.
To this end, Shanks says 'no': "[O]ur present institutions are less than adequate to oversee the new processes — and all but the most starry-eyed boosters agree that they are."
To be fair, the "Challenges and Options" report identifies at least two potentially problematic areas moving forward. First, synthetic biology is now capable of producing plants that don't fit under the jurisdiction of any existing agencies. Second is that the "expected influx of genetically engineered microbes, particularly those used in the environment, could overwhelm the capabilities of the EPA's Biotechnology Program, in terms of funding and expertise, to keep pace," reports GenomeWeb.
That last line captures, I think, the source of most of the precaution from critics like Shanks. Technology, they worry, is moving faster than regulation and policy can adapt. (Indeed, Shanks wrote a piece for CGS in Novemeber titled" Synthetic Biology: Scientific Advances Outstrip Policy Discourse.")
This is hardly a new fear, or a new criticism. It's the precautionary principle, and many people supportive of biotechnology worry that it will stifle innovation through a regulatory morass. It's easy to to understand biotech advocates' fears in light of the tortured story of the AquaBounty salmon, which seems trapped in regulation purgatory due to public fear and political pressure despite the fact that all of the science-based evaluations of the salmon's safety for environment and consumption have been passed. Ironically, both Shanks and the critics as well as the staunchly pro-biotech crowd agree that existing regulatory systems won't cut it, though one group wants more regulation and one wants less.
Reports like "Challenges and Options," for all their good intent, seem to neglect the gap in perception between the public and critical perceptions of synthetic biology and the perceptions of the scientists, entrepreneurs, and regulators who often write these reports.
It's this perception gap that is actually the biggest obstacle to the effective regulation of synthetic biology. Until it is addressed, no regulatory system will be able to operate effectively in a democratic country.
Kenrick Vezina is Gene-ius Editor for the Genetic Literacy Project and a freelance science writer, educator, and naturalist based in the Greater Boston area. Follow him on Twitter @Rickken.
- "Can Synthetic Biology Survive In A World Haunted By 'Frankenfood'?," Meredith Salisbury | Forbes
- "Engineering Biology to Address Global Problems: A look at synthetic biology markets, needs, and applications." Genetic Engineering & Biotechnology News
- "Policy Group Probes Regulatory Gaps in Synthetic Biology," Aaron Krol | BioIT World