Federal advisory panel recommends changes to select agent program

June 14, 2011:  A federal panel released recommendations today to better align laboratory security measures for biological agents and toxins with the risk each might pose to the United States if used in a terrorist attack. The Federal Experts Security Advisory Panel recommended that 11 agents and toxins, including anthrax, ebola and foot-and-mouth disease virus, be designated tier 1 in the National Select Agent Program, and that this tier require specific personnel and physical security measures for facilities possessing those agents and toxins.

The National Select Agent Program regulates the possession, use, and transfer of biological select agents and toxins. Agents and toxins in the program’s biological select agents and toxins list are used in some of America’s most secured laboratories as research tools to develop new and better methods to prevent or treat the diseases or health conditions the agents and toxins cause. Current regulations require the same security measures for all agents and toxins on the list.

The panel assessed the risks posed by all 82 of the substances currently regulated in the National Select Agent Program. Based on this assessment, the panel also recommended the removal of 19 agents and toxins from the list, due to their diminished risk for use in a high consequence event.

“The members of the panel believe strongly that biological select agents and toxins work is crucial to national security,” said George Korch, Ph.D., panel co-chair for HHS and the HHS acting deputy assistant secretary for preparedness and response. “The measures recommended by the panel represent best practices for personnel and physical security developed to increase security without unduly burdening the regulated community.”

The panel sent its recommendations to the National Select Agent Program managed by the U.S. Department of Health and Human Services and U.S. Department of Agriculture. HHS and USDA will consider the panel’s recommendations, along with feedback from stakeholders and the public, as part of a regular review of regulations that govern the National Select Agent Program. Any changes proposed to the select agent regulations will be announced in the Federal Register and available for public comment in the fall of 2011.

The panel was established in July 2010 by executive order after federal and non-federal reports addressing biosecurity of BSAT in the United States; and after the Federal Bureau of Investigation determined that the 2001 anthrax mailings were most likely perpetrated by a government laboratory employee.

The panel brought together experts from 15 federal agencies with a role in science, public health, law enforcement, intelligence, and security to recommend ways to optimize laboratory personnel security.

The panel will continue to consider emerging policy issues relevant to physical, cyber, and personnel security, including a comprehensive assessment of evidence regarding the utility of behavioral assessments in identifying indicators of potential for violent behaviors, criminal behaviors, or other behaviors that pose a national security risk.

More information on the Federal Experts Security Advisory Panel, including the panel’s full recommendations and a link to provide feedback, can be found at http://www.phe.gov/Preparedness/legal/boards/fesap/. To learn more about the Select Agent Program, visit http://www.selectagents.gov/.

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