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No Room For Error: A Common Sense Approach to "Synthetic Biology"

June 18th, 2014
By Jaydee Hanson, Senior Policy Analyst
Center for Food Safety

Last week, Grist published a piece by Nathaniel Johnson about an emerging commercial practice called 'synthetic biology' or 'extreme genetic engineering.' Rather than taking genes from one life form and inserting them into another as in traditional genetic engineering, synthetic biology seeks to build entirely new genes from their most basic components. Rather than cutting certain words from Huckleberry Finn and inserting them into Crime and Punishment, synthetic biology seeks to build letters which could theoretically be used to write anything you could imagine.

Many people, supporters and skeptics, recognize the potential for problems that could arise. For example, in Mr. Johnson's piece, he links to a video about a research facility that tests to ensure that the genes they build for clients are not toxic proteins. Others are concerned that simply inserting man made genes into nature will have unforeseen and potentially catastrophic consequences.

Recognizing these concerns, several organizations came together and drafted a set of principles, by which researchers could mitigate potential harms and assuage public concerns. As one of original drafters of the Principles for Oversight of Synthetic Biology, I appreciate Mr. Johnson drawing attention to the developing field as well as his efforts to educate his audience about the Principles.

Regarding the Principles, Mr. Johnson says, “[t]here’s a lot to admire in these principles... But many of these requirements are so broadly ambitious they look like they’ve been designed to guarantee failure.” That is not the case. Safety standards are not meant to generate failure, but to maintain safety. In fact, these standards are fairly common sense.

The first Principle is the Precautionary Principle, which has been incorporated in to laws and treaties worldwide. The U.S. routinely employs a version of the Principle, i.e., not approving a product when the data produced are insufficient to convince the regulator of a products safety.  The U.S. employed this to stop importing European beef because of concern over mad cow disease.

The second Principle, “Require mandatory synthetic biology-specific regulations,” is not just a concern shared by activists.  The J. Craig Venter Institute, founded by and named after a pioneer in the field of synthetic biology, has noted major gaps in regulation related to these products.  In a recent  paper the Institute warned of delays and legal challenges based on the lack of regulation.

The Third Principle, “Protect public health and worker safety,” needs careful attention by these new industries. For example, Becky McLain, a bioengineer working for Pfizer, could not get the company to enforce its biosafety rules after she was infected with a genetically engineered lenta virus and so went to OSHA to seek enforcement of biosafety rules.  For that “whistleblowing” she was fired. She later received a $1.4 million dollar award from the court for her wrongful firing, but she still can’t get her medical records as the company considers information about their genetically engineered virus “confidential business” information.  

The Fourth Principle, “Protect the environment,” is broad, but we discuss several very specific steps that companies can use to minimize risk. In the interest of space, I cannot recite them all here, but one option is physical containment. For example, Solazyme’s decision to use a heterotrypic microalgae is notable.  By choosing a microalgae that does not need sunlight, it can grow its algae in tanks which will help physically contain the organisms.  Unfortunately, Solazyme has asked the EPA to keep all of the data that it submitted to the EPA on the environmental safety of the organism as “confidential business information” that is not available to the public.

The Fifth Principle is “the right to know and democratic participation.”  We have had to fight for years to get data on toxic chemicals being produced in our communities; if the synthetic biology companies want to be considered “green” they will not make excessive claims of confidentiality on the health and safety risks of their products.

The Sixth Principle is “corporate accountability and manufacturer liability.”  This is not a naïve requirement.  Most businesses have insurance to cover such liability.  If the synthetic biology companies cannot produce adequate data to convince the insurers, their investors, and the communities in which they operate that they are safe, then governments should not be on the hook for future problems.

The Seventh and final Principle is “protect economic and environmental justice.”  The economic effects on those displaced by new ways of producing goods must also be addressed - even when the old technology is not a very green one, like palm oil from plantations developed on virgin forest land.  Indeed, the reaction of coal miners to the recent EPA proposals to control carbon dioxide pollution from coal fired power plants underscores the political need to address the job effects of even well designed changes in technologies. 

I appreciate Mr. Johnson's efforts to inform his readers about synthetic biology.  I trust that after learning about the technology and these Principles, they would not be “considered” radical. They do not attempt to ban research or turn away investors, but provide a template for companies and universities wishing to commercialize a product they believe have benefits.  In fact, the Principles are fairly similar to Mr. Johnson's own prepared (but undelivered) remarks to a conference examining how to market these products:

“The key to the GMO argument — and now, by extension, the synthetic-biology discussion — is transparency. Tell customers the truth and, if they like what you are doing, they’ll fight for you. Try to hide what you are doing from customers and they’ll fight against you. If you are going to use synthetic biology to make your product greener, then come right out and say it — show us that it’s an actual benefit.”

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