Public Health Emergency - Leading a Nation Prepared
October 13, 2010: Federal guidance issued today aims to reduce the risk that synthetic DNA will be misused deliberately to create dangerous organisms. Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA, issued by the U.S. Department of Health and Human Services, supports national biosecurity goals and balances the promise of synthetic DNA with its potential biosecurity risks.
Synthetic DNA is becoming a key material used in life sciences and biotechnology, including the emerging scientific field of synthetic biology. Among other applications, synthetic DNA is being used to develop new ways or improve existing ways to fight disease.
While there are significant potential benefits, synthetic DNA could potentially be used to recreate dangerous organisms that are covered under existing regulations. As such, development of technologies utilizing synthetic DNA must be encouraged in a safe and secure manner.
“This guidance is an important step in ensuring that synthetic DNA is used to promote, not threaten, public health,” said HHS Assistant Secretary for Preparedness and Response Dr. Nicole Lurie, whose office led the broad interagency effort to develop the guidance. “The guidance also recognizes the steps industry has taken proactively to address potential biosecurity risks and seeks to minimize negative impacts on research and business.”
Screening synthetic DNA orders may help to reduce the risk that an individual with malicious intent could access and use synthetic double-stranded DNA products to create a dangerous organism that is currently regulated. The guidance recommends baseline standards for use by companies to screen orders for synthetic double-stranded DNA products.
These recommendations include screening customers as well as DNA sequences, and follow-up screening as necessary. The guidance also recommends consulting with U.S. government contacts as needed, clarifies how to report suspicious orders, and encourages the industry to develop best practices in addressing potential biosecurity concerns.
In developing the guidance, the White House Office of Science and Technology Policy and the National Security Council staff convened a federal interagency working group which met with relevant stakeholders, including members of industry, academia, and federal agencies involved in synthetic DNA policy, and incorporated public input.
Because the technology, the industry, and the nature of the biosecurity risks are changing rapidly, the guidance will be reviewed by the federal interagency working group on a regular basis and revised as necessary.
Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA is available at http://www.phe.gov/syndna.
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