Regulating Synthetic Biology – Why the US Will Not Take a Precautionary Approach
Now that the United Nations Convention on Biological Diversity has urged nations to “take a precautionary approach” to regulating synthetic biology, it’s time for the United States to initiate regulatory procedures to limit the dangers of synthetic biology. The US federal government, however, has already dangerously decided that a precautionary approach to synthetic biology is not needed.
In 2010, the White House’s Presidential Commission for the Study of Bioethical Issues released a report stating that no new laws, policies, or procedures were needed to regulate biotechnology. The commission argued that the United States already has rules and procedures that are sufficient for limiting the potential risks of synthetic biology.
The rules and procedures already in place were developed in the 1970s and 80s to regulate biotechnology. At that time, genetic engineering was in its infancy, but laboratories were already developing techniques that would lead to the creation of Genetically Modified Organisms (GMOs). Discussions, at that time, about how to regulate biotechnology wavered between two positions. On one side were those who favored regulating biotech products, and on the other side were those interested in regulating biotechnological processes.
Those who favored regulating biotechnology on the basis of process argued that a whole new set of regulatory measures was needed for biotechnology because biotech products were created through completely new and novel processes; they were invented by people and not created through biological evolution (See Lynch and Vogel for more on this debate). In essence, biotech products should be put in a regulatory category of their own.
Those who favored regulating biotech on the basis of its products argued that biotechnological processes were no different than natural processes. They claimed that biotech products were natural products and should be evaluated using the same rules and regulations as anything else. In practice, this meant that if synthetically produced vanilla tastes like vanilla and smells like vanilla, it must be as safe as vanilla.
Of course, regulating biotechnology on the basis of safety would require evaluating the safety of both biotech products and processes. Thus, the debate was flawed from its very beginning. The reality is that regulatory agencies allow little independent and unbiased research into the effects of synthetic products on animals, human beings or the environment.
The argument that genetically engineered products are no different than naturally produced products is still used by biotech and agribusiness companies to shield their work from scrutiny. They argue, incorrectly, that synthetic biology is simply the latest iteration of an agricultural technique used by farmers for millennia. Most of the indigenous varieties of crops that humans use today are actually the end-products of centuries of selective breeding. Selective breeding occurs when farmers attempt to produce plants with an ensemble of desired characteristics by cross-breeding varieties that each display some of the desired qualities. Cross-breeding also happens in nature without human intervention, but genetic engineering and synthetic biology do not.
Genetic engineering and synthetic biology involve the artificial manipulation of an organisms DNA and assembling new strands of DNA that have never appeared in nature. The argument that synthetic biology is the same as cross breeding is completely false. The products of biotechnology and synthetic biology are NOT the same as natural organisms and need to be regulated according to a specially designed set of rules. They also need to be studied by independent researchers with no ties to corporate profits.
Former President of the Hastings Center, Thomas Murray, has pointed out that US regulatory agencies operate according to the “Proactionary Principle” instead of a precautionary principle. The proactionary principle says that when there is doubt about the safety of a technology, keep pressing ahead. This approach to regulation allowed genetically modified crops to be released onto the market without adequate research into their dangers. A precautionary approach urges scientists and governments to slow down be cautious when uncertainty and doubt arises. The precautionary principle is used in the European Union and elsewhere in the world.
Judging by the White House’s attitude to synthetic biology, the billions of corporate dollars beings poured into synthetic biology research, and the fact that a few companies are already preparing food additives produced with synthetic biology for sale on the market, makes it clear that the US federal government is determined to ignore all of the warnings given by the international community of nations.
If you’re concerned that the US federal government will not change course and regulate synthetic biology, you can take action by signing the petition to tell ice cream makers like Haagen Dazs, Dreyer’s, Edy’s, Baskin Robbins and others not to use this vanilla produced in synthetic biology laboratories in their ice cream.