Inspection of the FBI's Security Risk Assessment Program
for Individuals Requesting Access to Biological Agents and Toxins

E&I Report No. I-2005-003
March 2005
Office of the Inspector General

Executive Summary

The Department of Justice Office of the Inspector General conducted an inspection of the Federal Bureau of Investigation’s (FBI) Security Risk Assessment (SRA) Program, which was established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), Pub. Law No. 107 188. The SRA Program is part of an interagency effort to regulate the possession and use of dangerous biological agents and toxins, such as anthrax and the Ebola virus.

Under the Bioterrorism Act, a laboratory may not provide an individual with access to dangerous agents or toxins unless that individual has been approved by the Secretary of either the Departments of Health and Human Services (HHS) or Agriculture (USDA), based on an SRA. The SRA is conducted by the FBI, which searches electronic databases and other sources of information to determine whether the individual meets one or more of the criteria found in the USA Patriot Act (Pub. Law No. 107-56) and the Bioterrorism Act that would render the individual a “restricted person” ineligible for access to the biological agents and toxins controlled under the Bioterrorism Act.

We initiated the inspection in response to concerns about a backlog at the FBI of pending SRA applications submitted by researchers seeking access to controlled agents and toxins. To conduct this review, we examined SRA-related legislation and regulations, interviewed officials involved in the FBI’s SRA program, analyzed FBI monthly productivity reports showing the number and status of SRA applications in their Bioterrorism Database, and reviewed the case files of appeals of SRA decisions.


Our inspection showed that the FBI had 3,855 SRA applications pending in November 2003, but by June 2004, had reduced that number to 401. The FBI maintained a stable average monthly caseload of approximately 339 pending SRA applications through December 2004 and was routinely processing the applications in 45 days or less.

We also found that the FBI has instituted effective management controls that enabled it to identify and correct program vulnerabilities in a timely manner. The FBI set productivity goals for processing SRA applications and was closely monitoring its progress toward meeting those goals. It also established an appeals process for individuals who want to challenge "restricted persons" designations. In addition, to resolve interagency issues affecting the SRA Program, the FBI participates in an interagency working group that includes HHS, USDA, and other federal agencies concerned with regulating the possession and use of biological agents and toxins. We conclude that the FBI is effectively managing its SRA responsibilities under the Bioterrorism Act.