The U.S. government supports taking a voluntary rather than a regulatory approach to screening synthetic dsDNA orders at this time. The commercial DNA industry has acted responsibly in reaching out to the U.S. government to seek guidance. Providers and the U.S. government share the goal of reducing the chances that a Select Agent or Toxin (or a CCL item for international orders) could fall into the wrong hands.
Regulations already cover some types of synthetic orders of dsDNA. The U.S. Department of Health and Human Services and the U.S. Department of Agriculture, under the National Select Agent Program, already regulate nucleic acids that can produce infectious forms of Select Agent viruses and nucleic acids that encode the active forms of Select Agent toxins. Orders of synthetic dsDNA that fall into either category must comply with existing regulations (www.selectagents.gov).
Additionally, the field of synthetic genomics presents a novel challenge, and regulations may not provide the flexibility to address this challenge. The relationship between dsDNA sequence and pathogenicity (the ability of an organism to cause disease) is not currently understood well enough to be fully codified in regulation. While there is a body of knowledge on the mechanisms of disease, microbial physiology is controlled by an intricate balance of gene expression and regulation. Therefore, gene presence and structure do not necessarily predict an organism’s characteristics. Double-stranded DNA itself is not dangerous. Only when dsDNA is engineered to reconstitute an organism would safety, security, and regulatory concerns arise.
Regulations take time to develop and may need to be modified to keep pace with science. The field of synthetic genomics is evolving very quickly. A voluntary approach is one way to deal with many uncertainties about the future of the field. Initial screening recommendations have been outlined in the document, but these may need to be adjusted in practice. The approaches taken in the document will be evaluated on an ongoing basis.
Finally, if U.S. regulations were developed, they would only cover U.S. dsDNA providers, whereas providers exist all over the world. Voluntary guidance may provide a better opportunity to establish a baseline that is relevant internationally.