Will Overregulation In Europe Stymie Synthetic Biology?

I really liked this Forbes essay by Henry Miller & Drew Kershen. The topic is synthetic biology, but also useful is the history of the mis-regulation of genetic engineering. The authors conclude with this tidy summary of these mistakes:

(…) The future success of synthetic biology depends in large part on whether public policy toward its applications is well-crafted. Policymakers should learn from the regulatory missteps inflicted on genetic engineering that illustrate how choosing how choosing a flawed paradigm has critical implications for a technology.

Genetic engineers using increasingly powerful and precise tools and resources have achieved breakthroughs in a broad spectrum of fields, including agriculture, pharmaceuticals and diagnostics, in spite of the fact that thirty-five years ago, the U.S. National Institutes of Health adopted overly risk-averse guidelines for research using recombinant DNA, or ‘genetic engineering’ (also known as ‘genetic modification,’ or GM) techniques.

Their approach was based on what has proved to be an idiosyncratic and largely invalid set of assumptions that overestimated the novelty and potential risks associated with the process of gene transfer and from the recombinant DNA-modified organisms themselves. Those guidelines sent a powerful message that the scientific community and the federal government were taking the speculative, exaggerated risk scenarios seriously, a message that has affected – and afflicted — regulation worldwide ever since. Unwilling to diminish their bureaucratic empires, the U.S. EPA and Department of Agriculture have clung tenaciously to unscientific, burdensome, costly regulatory policies.

However, at least where non-corporate activities are concerned, from the supra-national to the local level, unnecessarily intrusive regulation may become harder to impose on synthetic biology. What will federal (USDA, EPA, and FDA) and other regulators do about garage-inventor synthetic biologists who produce and test novel plants and microorganisms? Will they try to subject these ‘made-from-scratch’ organisms to the same technique-focused, unscientific, excessively burdensome regulatory frameworks designed for recombinant DNA-modified organisms?

The European Union and the United Nations’ Cartagena Protocol on Biosafety face the same regulatory conundrum. At both, the regulation of genetic engineering is explicitly triggered by the process by which a plant is crafted rather than by the risk-related characteristics of the product, and the UK Research Councils analysis has expressed concern that the regulations for genetically engineered plants will likely also be applied to synthetic biology. With prototypical British understatement, the report said, ‘Currently there are some problems with the operation of the EU clearance processes, and this could act as a barrier to commercialization of certain synthetic biology products. The UK government is currently engaged in [revising] EU regulations with the aim of enabling more effective operations of the current regulatory system.’

Henry I. Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution. He was the founding director of the Office of Biotechnology at the FDA. Drew L. Kershen is the Earl Sneed Centennial Professor of Law (Emeritus), University of Oklahoma College of Law, in Norman, Okla.

(Via Henry Miller- Rationalist.)


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