The U.S. Department of Health and Human Services (HHS) released its much-anticipated Guidance report on Wednesday, Oct. 13th 2010, describing a recommended screening method for synthetic double-stranded DNA (dsDNA) manufacturers. The report provides the recommended framework for the screening of orders to ensure manufacture compliance with current Select Agent Regulations (SAR) and Export Administration Regulations (EAR) and reduce the risk of supplying products to individuals that may exploit this dual-use technology for malicious intent.
The rapid advancement of synthetic DNA technology has prompted much debate on how to address the biosecurity concerns raised by the possible ability to synthesize Select Agents de novo, given that current U.S. policies and regulations do not adequately address this issue. The recommendations by The National Science Advisory Board for Biosecurity (NSABB), released in 2007, call for federal action to promote risk management in laboratories while limiting the negative impact on business and scientific progress.
Although most major DNA synthesis providers have already established their own protocols to minimize the risk of distributing to unauthorized individuals or individuals with ill intent, the HHS Guidance serves as a standard model screening procedure that can be easily implemented without unnecessary cost, both nationally and internationally. It stresses that providers are responsible for who they distribute their products to and whether or not these products contain a “sequence of concern.” The framework is voluntary and meant to assist manufacturers in meeting these responsibilities.
The HHS Synthetic dsDNA Screening Framework establishes a three-part screening process upon the arrival of a synthetic dsDNA order: customer screening, sequence screening, and follow-up screening:
1. Customer screening verifies the individual or organization to which the order will be received by. This will identify potential “red flags” and limit sales to unauthorized or suspicious individuals.
2. Sequence screening identifies orders for “sequences of concern”. These sequences are whole or parts of whole sequences derived from the HHS and USDA-classified list of Select Agents and Toxins. “The U.S. Government recommends that all orders of synthetic dsDNA be subject to a screening framework that incorporates both customer screening and sequence screening,” as stated in the report.
3. Follow-up screening is further recommended if customer screening and/or sequence screening raises a cause for concern, verifying the legitimacy of the customer and end-use of the product.
Synthetic biology provides significant benefits to scientific advancements. However, it is important for governments to work with industries in developing guidelines to help obviate the potential dual-use capabilities of this technology. “This guidance is an important step in ensuring that synthetic DNA is used to promote, not threaten, public health,” HHS Assistant Secretary Nicole Lurie said in released remarks.