The 1980s brought further developments in genetic manipulation and gene replacement, most importantly, the ability to reverse engineer a virus. The first complete clone of an animal virus genome was for a plus strand virus, which was synthesized and expressed, in 1981 (bacterial viruses had been genetically manipulated previously). In 1993, scientists synthesized and expressed a negative strand virus (influenza is also a negative strand virus) and had, by 2007, synthesized and expressed a double stranded virus.

By the 2000s, it was possible to add or remove biological functions genetically to examine the effect on a pathogen’s virulence or transmissibility. This capability allowed laboratory scientists to investigate evolutionary questions in a manner that had never before been possible. A common experimental design involved creating an environment hospitable only to organisms possessing a specific trait—for example, virulence or transmissibility. Genetic material from surviving organisms would be sequenced in order to identify the mutation(s) responsible for specifically selected traits. Genetic material associated with the mutations would be extracted and inserted into new viruses to determine whether they caused the appearance of the trait.

In parallel with these developments, there was ever increasing access by ever larger numbers of people to the tools and information needed to manipulate potentially lethal viruses. The equipment necessary to rapidly sequence and reconstruct genomes, for instance, has become affordable and knowledgeable, both of genomics and of how to use the relevant equipment, has become readily available. As a result, access to potentially dangerous information has expanded well beyond the boundaries of what has traditionally been considered the scientific community, both in the United States and internationally.

With particular regard to influenza viruses, Brent noted that researchers have publicly stated, since at least 2004, the goal of constructing human-transmissible H5N1. The rationale behind the goal is that the relative ease or difficulty of the task will provide an indicator of the relative risk posed by the H5N1 virus to public health.

Regulatory Developments Prompted by These Advances

In 1974, in light of the development of recombinant DNA technology and the uncertainties surrounding its safety, the scientific community imposed a moratorium on further research, and in 1975, convened a conference at the Asilomar Conference Center in California for the purposes of defining a framework for governing recombinant DNA technology and its products. The Asilomar Conference (see Box 2-1) was followed in 1976 by NIH’s regulatory framework for recombinant DNA, which included local control (in the form of Institutional Biohazard Committees) and national

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