Synthetic Genomics Applicability of the Select Agent Regulations to Issues of Synthetic Genomics The Federal Select Agent Program is providing guidance regarding the application of the current select agent regulations to those who create and use synthetic genomic products. In a December 2006 report entitled "Addressing Biosecurity Concerns Related to the Synthesis of Select Agents" (www.biosecurityboard.gov/links.asp), the National Science Advisory Board on Biosecurity recommended that the Federal government take steps to "Increase awareness among providers and users of synthetic genomic materials regarding compliance with the select regulations; and provide a list of genomic materials explicitly covered by the regulations." The select agent regulations provide that the following genetic elements, recombinant nucleic acids, and recombinant organisms are select agents (See section 3(c) of 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331):
The purpose of this regulatory language is to address advancements in molecular biology that may influence the production of infectious forms of select agent viruses, or the active forms of select agent toxins. It has been demonstrated, for example, that the single stranded (positive strand) RNA viruses and certain double stranded DNA viruses that utilize host polymerases contain nucleic acids that can produce infectious forms. Examples of select agent viruses that meet this criterion, and would therefore be regulated, include:
Under the current select agent regulations the following are examples of materials that would not be regulated as a select agent:
The following examples, Example scenarios involving synthetic genomic select agent materials, while not inclusive of all potential scenarios, illustrate the application of the current select agent regulations to activities involving synthetic genomics or synthetic biology. The Department of Health and Human Services' Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA sets forth recommended baseline standards for the gene and genome synthesis industry and other providers of synthetic dsDNA products regarding the screening of orders so that they are filled in compliance with current U.S. regulations and to encourage best practices in addressing biosecurity concerns associated with the potential misuse of their products to bypass existing regulatory controls. |
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