Regulating Industry Uses of Synthetic Biology

A new paper in the journal Science argues that regulatory options being considered for synthetic biology should support the potential for innovation and the commercialization of new products.
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Synthetic biology recently leaped into the public eye, prompting a few concerns analogous to those raised at the emergence of genetic engineering in the 1970s. But synthetic biology should be seen as the next step in the continuum of genetic science that has been used safely for more than 40 years by the biotechnology industry. The speed and efficiency of DNA synthesis and sequencing combined with growing mountains of genomic data are enabling advanced methods for production of commercial biotechnology products, such as proteins, and renewable chemicals.

Examples of synthetic biology use by biotech companies illustrate the potential to bring new products to market, including biofuels, renewable chemicals and specialty chemicals, bioproducts, pharmaceutical ingredients, health products, and food ingredients. A new paper in the journal Science, by Brent Erickson, Rina Singh, and Paul Winters of the Biotechnology Industry Organization (BIO), argues that regulatory options being considered for synthetic biology should support the potential for innovation and the commercialization of new products.

Some of the earliest researchers in synthetic biology came from the traditional field of engineering. And certainly, the development of computers that sequence, store and process genomic data have enabled the advancement of the field. But the authors of the paper argue that the need for regulation of synthetic biology is different from the regulation of engineering or computers. Rina Singh explains why in a podcast with Science.

Innovation for any industry is based on increased speed, efficiency, performance and cost-effectiveness within product development. Synthetic biology enables this type of innovation by allowing more complex, multistep fermentation of organic chemicals and longer gene synthesis. Synthetic biology describes a set of tools that will aid the continued evolution of biotechnology, including applied protein design, the standardization of genomic “parts,” or oligos, and synthesis of full genomes.

BIO’s fact sheets “Current Uses of Synthetic Biology”and “Biotechnology Solutions for Renewable Specialty Chemicals & Food Ingredients” provide a number of examples where synthetic biology has enabled the speedy, cost-effective construction and testing of complex prototype biological systems for research and product development within the chemical, pharmaceutical, and food industries. See also a previous article by Rina Singh, “Facts, Growth, and Opportunities in Industrial Biotechnology.”

The use of synthetic biology in these examples are providing companies the opportunity to shorten research and development time and increase speed to market. It also allows the design and synthesis of renewable chemicals and biobased products, where either no naturally occurring solution existed or the use of a petrochemical solution was not economically viable. These few examples illustrate the potential for synthetic biology, and this potential informs the debate over regulation. Regulatory options should support innovation and commercial development of new products while protecting the public from potential harms.

Options for governance

One of the key needs for regulation identified by the synthetic biology community is to inculcate the biomedical culture of safety in engineers, chemists, material scientists, computer modelers and others drawn into the field of synthetic biology by its interdisciplinary nature. See for instance, the chapter “Synthetic Biology” in The Hastings Center Bioethics Briefing Book. Or the work of Andrew Balmer and Paul Martin for the Biotechnology and Biological Sciences Research Council (BBSRC).

The U.S. Government has also developed recommendations for a framework for synthetic nucleic acid screening. This voluntary-user document provides guidance to synthetic genomic producers for sharing synthesized genetic sequences. In addition, NIH established the NIH Guidelines in 1976, which are mandatory for investigators at institutions receiving NIH funds for research involving recombinant DNA. The guidelines encompass synthetic biology and are followed voluntarily by scientists and organizations, both public and private.

The President’s Bioethics Commission, charged with reviewing the field of synthetic biology and identifying appropriate ethical boundaries, advocated prudent vigilance – which balances responsible stewardship of the technology with intellectual freedom for continued investigation – and regulatory parsimony – establishing only as much oversight as is necessary to ensure public safety and public benefits from the technology. They also recommend that regulators have adequate information to conduct risk analysis and harmonization of regulatory standards.

The Science paper concludes that at this early stage of development, synthetic biology does not pose significant novel threats that are fundamentally different from those faced by the biotechnology industry. The regulatory framework that has been shaping recombinant DNA technology for the past 40 years is generally applicable and relevant. In the future, as the technology matures, the need may exist to develop a regulatory framework as overarching federal policy that would be based on existing voluntary regulatory guidelines. 

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