As Congress returns from summer recess, and national campaigns begin, job creation is undoubtedly the theme for the near term. Debates over the role of government in stimulating economic growth through fiscal and regulatory policy are inviting opinions from all sides of the political spectrum. Despite all the contention that is and will continue to ensue, there is generally one agreed-upon precept: innovation is a valuable tool to create and sustain economic growth. But how does the quest for innovation square with government regulation? That debate is taking shape not only broadly but in the nascent field of synthetic biology, where scientific, public-health, and business interests are converging.

In a recently published paper in Science, the Biotechnology Industry Organization (BIO) put forth the case for synthetic biology and the role that regulation should play (1). “Synthetic biology is not something radically new, but is part of an ongoing evolution of biotech innovation that has safely and successfully produced public benefits for the past 40 years,” said Brent Erickson, executive vice-president of BIO’s Industrial and Environmental Section, in a BIO press release.  “At this early stage of development, the technology does not pose significant novel threats that are fundamentally different from those faced by the current biotechnology industry. The regulatory framework developed over the 40-year history of the biotechnology industry is generally applicable and relevant for the products of synthetic biology.” Erickson also was a coauthor on the Science paper.

The article points to improvements in the speed and cost of DNA synthesis to enable scientists to design modified bacterial chromosomes that can be used in the production of renewable chemicals, biofuels, bioproducts, renewable specialty chemicals, pharmaceutical intermediates, fine chemicals, food ingredients, and healthcare products. “Regulatory oversight of this emerging field should foster and promote innovation, establishing only as much regulation as is necessary to ensure public safety and benefits,” said Erickson in the BIO release. “Synthetic biology offers the United States the opportunity to establish a leadership position in a growing sector that can revitalize our traditional industries and at the same time stimulate economic growth.”

The Presidential Commission for the Study of Bioethical Issues released a report in December 2010 that supported continuing research in the emerging field of synthetic biology with some additional federal oversight. President Obama had asked the commission in May 2010 to study the implications of synthetic biology following the announcement by the J. Craig Venter Institute, a genomic-research organization founded and headed by J. Craig Venter, who helped map the human genome, that his group had successfully constructed the first self-replicating synthetic cell.

The debate on synthetic biology has centered along two broad lines. Researchers envision that the knowledge gained by constructing the first self-replicating synthetic cell, coupled with decreasing costs for DNA synthesis, will give rise to wider use of the technology to be applied in developing therapeutic and industrial products such as drugs, vaccines, and biofuels. But there also are misgivings. Some have raised concerns over the deliberate misapplication of synthetic biology as a potential tool in facilitating bioterrorism or see synthetic biology as too novel a science to adequately understand the risks and possible harmful effects that it may pose to human and environmental health.

The question at this early stage begins with not how synthetic biology should be regulated, but how the process for regulation should evolve. The novelty of this field requires what should also be an objective in any regulatory framework: a collaborative model shaped by industry, academia, public-health advocates, environmental groups, and other stakeholders. The debate thus far has gravitated toward “precautionary principles,” which seek to limit the development of synthetic biology until the potential risks or lack of risks are more fully known to “prudent vigilance,” which seeks to proceed with development while considering concerns.

Amy Guttman, chair of the Presidential Commission for the Study of Bioethical Issues, recently summed up the commission’s position. “Prudent vigilance shares with the precautionary principle a concern for identifying and mitigating risks. However, it advocates continued progress in the pursuit of potential benefits in tandem with that ongoing sensitivity to risks and the development of appropriate responses,” she said an Hastings Center report. “The commission believes that prudent vigilance will prove to be a valuable approach to the assessment of risks related to synthetic biology and other emerging technologies.”

Let’s hope that in the often polarized environment that shapes our public discourse that a clear path that meaningfully and fully engages all stakeholders in considering related concerns, benefits, and risks is the one constant that emerges in the evolving field of synthetic biology.

Reference
1. B. Erickson, R. Singh, and P. Winters, Science 333 (6047), 1254–1256 (2011).