Patricia F. Fitzpatrick Dimond Ph.D. Technical Editor of Clinical OMICs President of BioInsight Communications
Understanding why risk is linked to this field could go a long way to managing perceptions and regulations.
As novel scientific achievements such as recombinant DNA technology, stem cells, and most recently, synthetic biology, exit the lab and merge with the outside world, fear has followed them. This fear factor has influenced public perception of most novel scientific endeavors.
Biotechnophobia seems to stem from the fact that the risk is human-made. People are less worried about natural risks, David Ropeik, founder and principal of Ropeik and Associates, a risk management consultancy, wrote in The Guardian.
“Nature can indeed be red in tooth and claw, but new versions of plants, animals, and microorganisms that evolve via Darwinian evolution don’t upset us half as much as hybridization by genetic engineering.” We will need to understand and come to terms with factors that bias our risk perceptions, Ropeik warned, or we may fail to exploit breakthroughs like synthetic life.
There are indeed organizations to assess risk and monitor potential hazards associated with biotechnologies. In October 1974, NIH established the Recombinant DNA Advisory Committee (RAC) to respond to public anxiety about the safety of manipulating genetic material through the use of recombinant DNA techniques.
NIH has assessed its “Guidelines for Research Involving Recombinant DNA” with regard to synthetic biology and found that the distinction between recombinant and synthetic techniques is immaterial in discerning the need for biosafety oversight. Rather it is the biological attributes of the final product that should be taken into account. As part of the assessment it amended the guidelines document to include nucleic acids that are synthesized chemically without the use of recombinant technology.
Yet, as recently as March 13, a group of 111 watchdog organizations including ETC Group and Friends of the Earth issued a report saying that current practices for regulating and assessing biotechnology were inadequate. They called synthetic biology “an extreme form of genetic engineering” and asked for a moratorium on the release and commercial use of synthetic organisms and their products.
The excitement over synthetic biology resurfaced on reports in May 2010 of the development of a “synthetic cell,” although only the genome was synthetic. Dr. Venter and his team reported that they had assembled a 1.08 mega base pair Mycoplasma mycoides JCVI-syn1.0 genome using digitized genome sequence information. The scientists transplanted the genome into a M. capricolum recipient cell to create new M. mycoides cells controlled only by the synthetic chromosome.
Reactions to the artificial cell, named “Synthia” by its developers, were exemplified by newspaper headlines like “Scientist Craig Venter creates life for first time in laboratory sparking debate about ‘playing god’” and “Artificial life has been created in a laboratory for the first time by a maverick scientist”.
Dr. Venter pointed out that he requested a bioethical review of the field in the late 1990s and has participated in various discussions on the topic. “I think this is the first incidence in science where the extensive bioethical review took place before the experiments were done. It’s part of an ongoing process that we’ve been driving, trying to make sure that the science proceeds in an ethical fashion,” he said.
Under NIH’s “Guidelines for Research Involving Recombinant DNA,” recombinant research involves molecules that are constructed outside living cells by joining natural or synthetic molecules to DNA molecules that can replicate in a cell. The institute has assessed the guidelines with respect to synthetic biology, in particular de novo synthesis of nucleic acids.
This assessment—informed by ample scientific and public input in writing and at public meetings—concluded that the synthesis of nucleic acids raised the same biosafety considerations as more conventional recombinant techniques and thus should be subject to the same biosafety oversight, RAC said to GEN through NIH.
In the March 1 issue of Nature, Genya V. Dana and colleagues at the Woodrow Wilson International Center for Scholars and Ohio State University re-emphasized the need to proactively address environmental risks so that the benefits of synthetic biology can be realized. At least $20 to $30 million in government research will be needed over the next decade, they said, to adequately identify and address the possible ecological risks of synthetic biology.
The authors noted that “no one yet understands the risks that synthetic organisms pose to the environment, what kinds of information are needed to support rigorous assessments, or who should collect such data.” In contrast to genetically modified crops, they said, synthetic biology products “will be altered in more sophisticated and fundamental ways such as elimination of metabolic pathways, making them potentially more difficult to regulate, manage, and monitor.”
The authors further stressed the importance of starting this evaluation of syn bio as the field is advancing. “Synthetic biology has already moved out of the lab, propelled by significant public and private investments in organisms modified to produce chemicals, medicines, and biofuels,” they wrote.
Balancing the Hysteria
The Synthetic Biology Project at the Woodrow Wilson Center found that as of 2010, the U.S. government has spent around $430 million on synthetic-biology-related research since 2005, with the Department of Energy funding most of the research.
Industry has also shown considerable enthusiasm since the development of Synthia. Synthetic Genomics snagged a $600 million contract with Exxon Mobil to design algae that can capture carbon dioxide and make fuel. The company, founded by Dr. Venter, provided $30 million to fund the Synthia project and owns the intellectual property rights to the cell-creation techniques.
Commenting on synthetic biology, Christopher Voight, while working at UCSF, was quoted as saying. “I think this quickly will be applied to all the most important industrial bacteria.” In 2011, Dr. Voight moved to MIT to become the co-director of MIT’s Synthetic Biology Engineering Research Center (SynBERC). A five-year, $17 million grant from the NSF supports the center.
Plenty of contentious opinions, nonetheless, continue to form around synthetic biology. It remains to be seen how far the ETC Group/Friends of the Earth action will go in pushing for more regulation and a moratorium on syn bio products. The Biotechnology Industry Organization said this about the watchdog group’s proposal: “with the shrillness of its tone and its lack of objectivity, I don’t think it’s really helpful to policy-makers and the public.” Indeed, what is needed is a balanced, informed, open forum on the realities of synthetic biology.
Patricia F. Dimond, Ph.D. ([email protected]), is a principal at BioInsight Consulting.