Policy Group Probes Regulatory Gaps in Synthetic Biology
By Aaron Krol
May 30, 2014 | This week, a policy group including representatives from the J. Craig Venter Institute, the University of Virginia, and the European Molecular Biology Organization released a report questioning whether current U.S. regulatory structures are sufficient to address safety and environmental concerns raised by synthetic biology. While the authors are encouraged that most products of synthetic biology, including foods, drugs, and engineered animals and microorganisms, should be adequately regulated under U.S. law as written, they do identify potential pitfalls that may arise as synthetic biology becomes more widely practiced.
Most significantly, existing law may not provide the government with the authority to regulate genetically modified plants produced through synthetic biology. Genetically modified plants currently fall under the remit of a division of the USDA, the Animal and Plant Health Inspection Service (APHIS), whose authority rests on a legal technicality. Most genetic engineering of plants today takes advantage of plant pests as vectors to introduce foreign genetic material, and because APHIS has jurisdiction over plant pests, it is entitled to monitor products created using plant pests before their release into the environment. "As a result," write the authors, "unlike other agencies that have responsibility over genetically engineered organisms, APHIS’ authority over genetically engineered plants turns primarily on a technique," rather than the products being regulated themselves.
In addition, it seems that APHIS has never had the power to actually ban or restrict an engineered plant unless the plant itself proves to be a plant pest. "APHIS has no authority under its plant pest authorities to make regulatory decisions based on impacts such as increased weediness or invasiveness, undesired gene flow to unmodified crops, increased herbicide use, or other environmental or economic impacts," the authors conclude.
Synthetic biology is rapidly yielding techniques for modifying the native genomes of plants without using plant pests as vectors. To correct the current regulatory gap for these products, the policy group proposes several solutions, including new legislation that expands the USDA's authority over genetically engineered plants created by any means, or the EPA taking command of reviewing new plants under its jurisdiction over "new chemical substances," which have traditionally been broadly defined.
A second area of concern for the authors is a rise in the volume of genetically engineered microbes, if advances in synthetic biology make it easier to manufacture these organisms on a larger scale. "Some companies with large synthetic biology programs, including those producing algal biofuels, may consider dozens or even hundreds of variants of their microbial products during product development, each of which would require a TERA [Toxic Substances Control Act Experimental Release Application] for field testing," write the authors. Here, the report concludes that the EPA has the legal authority to regulate new products, but may find its resources fall short of industry's ability to create new microbes. It also outlines potential weaknesses in the Toxic Substances Control Act from which this authority derives.
The authors do not see an immediate need to overhaul the EPA's oversight of engineered microbes, but they do suggest that additional funding, as well as a fast track for low-risk types of microbes, may become necessary in the future. They also suggest certain legislative actions that could shore up the Toxic Substances Control Act as it applies to microbes.
The report is a thorough review of the regulatory landscape around synthetic biology, and both members of relevant industries and regulators should find it worth reading in its entirety. It was funded by the Department of Energy and the Alfred P. Sloan Foundation, and can be read on the website of the J. Craig Venter Institute. It should be noted that the Institute fosters new synthetic biology techniques in a research capacity, and that founder and CEO J. Craig Venter is also founder and CEO of Synthetic Genomics, Inc., which seeks to create commercial products through synthetic biology.