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AAAS is asking for your opinions on laboratory, pathogen, and personnel security to help inform important governmental policy decisions.

Since 2001, the U.S. government has made significant changes to how laboratory research is conducted, particularly with a select group of pathogens called “select agents.” The US has expanded the select agent list, increased restrictions on access, limited foreign scientists from visiting the U.S., and is currently debating additional oversight of legitimate biological research to minimize the potential biosecurity risks of the research and advancing biotechnologies. More information about current biosecurity policy initiatives are listed below.

On January 9, 2009, President George W. Bush issued Executive Order 13486 on Stengthening Laboratory Biosecurity, which established an interagency working group to review all laws and regulations regarding select agents, oversight of high-containment laboratories (biosafety levels 3 and 4), and personnel reliability (vetting personnel seeking access to select agents). This review will encompass accountability, storage, transportation, and handling of select agents. At the public consultation on May 13 and May14, the discussion included: 1) licensure of scientists; 2) training programs for biosecurity and safety; 3) common set of operating standards for all institutions; 4) a tiered approach to classifying select agents; 5) the feasibility and consequences of inventorying biological agents; 6) feasibility and strategies for implementing a program on allowing access to high-containment laboratories (“personnel reliability”); and 7) sharing information about the research facilities’ security plans.

Although the topics were focused on research conducted with select agents, new policies could affect more broadly the conduct of biological research in the U.S. The interagency review provides a unique opportunity for the scientific community to give their opinions on these issues. AAAS will make sure that your voices are heard, and will help guide the policy decisions that will have broad ramifications for both national security and the climate for science both in the US and globally.

We invite you to add your comments below. Your comments will be made available to the White House Office of Science and Technology Policy and the interagency working group on June 12. Anyone seeking to comment after June 12, can do so to further the conversation and/or provide AAAS with your views for future policy discussions on laboratory biosecurity.

Laboratory Biosecurity
President George W. Bush released Executive Order (EO 13486) on January 9, 2009 on strengthening laboratory biosecurity. This EO created an interagency working group to review all U.S. laws and regulations on select agents, oversight of high-containment laboratories, and personnel reliability; to identify gaps and/or challenges; and to provide recommendations to address those gaps and improve laboratory biosecurity.

The Select Agent Program The Select Agent Program and Biosafety Improvement Act, which was introduced in the House (H.R. 1225) and Senate (S.485) in February 2009, reauthorizes and requires review of the Select Agent Program (SAP), requires revision of the list of select agents and the criteria for including agents on the select agent list, requires review of oversight of high-containment labs, calls for improvement of biosafety training, and calls for establishing a voluntary reporting system of laboratory exposures.

The National Science Advisory Board for Biosecurity (NSABB) issued their recommendations on synthesis of select agents in 2008. Their synthetic biology recommendations were that the U.S. government should examine the method for classifying select agents and evaluate the language and implementation of biosafety guidelines to accommodate de novo or synthetically-derived DNA.

The National Academies has initiated a study on scientific milestones for a gene sequence based classification system for oversight of select agents. This is based on the NSABB recommendation described above.

Oversight of High-Containment Laboratories The Department of Health and Human Services established the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight to consider oversight of research conducted in high-containment laboratories.

In December 2008, the Commissioners of the Commission on the Prevention of WMD Proliferation and Terrorism testified to the Senate Homeland Security and Governmental Affairs Committee (HSGAC) that there no single agency has jurisdiction for overseeing high-containment laboratories (BSL-3 and BSL-4). They advocated for an agency whose mission is security-focused to take the lead in oversight of these labs.

HSGAC Chairman, Senator Lieberman, and Ranking Member, Senator Collins, are preparing a bill on oversight of high-containment laboratories in the U.S. and globally. The bill has not been introduced.

The Biological Weapons Convention 2008 Intersessional Meetings addressed efforts and challenges of biosafety and biosecurity of high-containment laboratories.

Personnel Reliability Following the allegation against Bruce Ivins, a researcher at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), as the suspect of the 2001 anthrax attacks, the U.S. government became concerned about the “insider threat” and vetting personnel seeking access to select agents, termed “personnel reliability.”

The NSABB released their recommendations on personnel reliability in April 2009, which recommends against a formal, national personnel reliability program for select agent researchers, while supporting enhancement of existing measures and a culture of responsibility and accountability within institutions conducting select agent research. These recommendations will contribute to the EO 13486 interagency review.

The National Academies have established a committee to review personnel assurance. The report is scheduled for release in September 2009. These recommendations will contribute to informing implementation of the policy recommendations resulting from the EO13486 interagency review.