Letter published in the Bulletin of Atomic Scientists (September/October 2007)
Drew Endy envisions a future in which the ability to design novel organisms through synthetic biology is as widely accessible is the ability to design novel computer programs. Such a future may bring many benefits, but it also poses risks. The damage that might be wrought by some “biohackers” would be much more difficult to deal with than that caused by their computer hacker brethren.
Endy recognizes that significant security concerns accompany synthetic biology, and his ethical principles are admirable. But ethical prescriptions alone are not enough to ensure that malefactors will be “as few in number and as limited in skill and equipment as possible.” Laws, rules, and regulations – and effective mechanisms for implementation and enforcement – are needed to transform ethical principle into operational practice.
Writing in the journal Nature Biotechnology, Endy and colleagues recently suggested that individuals who place orders with DNA synthesis companies be required to include certain identifying and biosafety information with their orders. In this way, researchers and their institutions would screen the orders against a selected set of pathogens and sequences, and in doing so assume and maintain some accountability for compliance with regulations. Suspicious requests would be reported to government law enforcement agencies.
This proposal should be applauded, but it raises several significant questions: To what meaningful authority would customers and institutions be accountable, and how would accountability be manifested? With what “regulations” would compliance be ensured? At present, there are no regulations. By what criteria could companies reliably identify a “suspicious” synthesis request? What about institutions and facilities that maintain their own internal synthesis capabilities?
In each case, there is a role for laws, rules, and regulations. For instance, the U.S. select agent law, which regulates the possession and transfer of certain pathogens such as anthrax and the ebola virus, could be extended so that only individuals who are registered to handle select agents would be permitted to order select agent genomes. A requirement that all DNA synthesis machines be licensed, and all orders screened, could be enacted. It might make more sense, and be more equitable, if public policy required that all orders for certain types of sequences be automatically reported to governments (with strong privacy provisions). A mandatory system of prior review and approval of all high-risk research projects would greatly strengthen prevention efforts. Evidence of prior approval could be made a condition for receiving certain types of DNA sequences. After all, it is not just what biological agents you are working with, but what you are doing with them and why that matters.
Dr. Alan Pearson
Director, Biological and Chemical Weapons Control Program
Center for Arms Control and Non-Proliferation