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HHS Issues Guidance Against Synthetic DNA Mischief

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US government today issued guidance to prevent the misuse of synthetic DNA to create dangerous organisms.

The US Department of Health and Human Services issued the guidance, called "Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA," as baseline standards for companies to use when screening orders for synthetic double-stranded DNA products.

The guidance, it said in a statement, supports national biosecurity goals "and balances the promise of synthetic DNA with its potential biosecurity risks."

HHS recommends screening customers as well as DNA sequences, and follow-up screening as necessary. It also suggests consulting with US government contacts as necessary, clarifies procedures for reporting suspicious orders, and encourages the industry to develop best practices to address potential biosecurity concerns.

The guidance comes in the wake of recent advances in synthetic biology, including the announcement by the J. Craig Venter Institute that it had created the first functional bacterial cells controlled by a synthetic genome, and most recently that it had created the first synthetic organellar genome.

Meanwhile, companies such as Life Technologies and Origene have moved deeper into the synthetic biology space in anticipation that the market may soon take off financially. Just this week, Life Tech licensed DNA-correction technology as part of its strategy to widen its footprint in the market.

Before today's announcement the White House and Washington legislators had expressed their concerns over developments in the space.

In its announcement today, HHS said that synthetic DNA is becoming a "key material" in life science and biotechnology applications, including synthetic biology, but while there are potential benefits to the use of the technology, it can also be used to recreate dangerous organisms that are covered under existing regulations. As a result, the development of technology using 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 Nicole Lurie, HHS assistant secretary for preparedness and response. Her office is leading the effort, which includes a broad membership of federal agencies, to develop the guidance.

The guidance, she added, also recognizes the efforts made by industry to address potential risks and "seeks to minimize negative impacts on research and business."

The White House Office of Science and Technology Policy and the National Security Council convened a federal interagency working group which met stakeholders, including members of academia, industry, and federal agencies involved in synthetic DNA policy, and incorporated public input in order to develop the recommendations.

The guidance will be reviewed and updated by the federal interagency working group as necessary in order to reflect rapid changes in industry, technology, and biosecurity risks.

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