US amends 'select agent' regs

CDC, USDA to offer provisional clearances if background checks remain incomplete

Nov 10, 2003
Jeffrey Perkel(jperkel@the-scientist.com)

Scientists who work with select biological agents and toxins but who have not yet been issued certificates required by the US Centers for Disease Control and Prevention (CDC) and the US Department of Agriculture (USDA) can breathe easier now. As long as such researchers have submitted all necessary documentation to the government before a November 12 deadline, they can be issued provisional registration certificates and grants of access if mandatory Federal Bureau of Investigation (FBI) background checks haven't been completed, according to Ted Jones, acting director of the CDC' Select Agent Program.

Last week, Jones told The Scientist that “final decisions haven't been made” on how to deal with researchers who had completed paperwork but whose FBI clearances had been delayed. The amendment now clarifies their response to this issue.

Under the “select agent rule,” researchers needing access to select agents—a collection of 80 or so bacteria, viruses, and toxins that could pose a threat to human health or agriculture—must undergo security risk assessments by the FBI and a separate lab inspection by either the CDC or the USDA. Jones said last week that those labs whose paperwork is in order but that have not yet been inspected by the CDC would be given permission to continue working after the November 12 deadline. A USDA spokesperson said at the time that labs wishing to work with select agricultural agents could receive a 3-year certificate of registration without inspection.

The FBI background checks were to have been completed by June 12, and the rules fully implemented by November 12. But many of the 8000 or so background check requests have not yet been completed. According to the Federal Register, where the amendment was published, the FBI Criminal Justice Information Services (CJIS) Division “has finalized over 5000 security risk assessments” and expects to process “almost all of the completed applications that were pending as of October 1, 2003” by November 12. But CJIS also has sent “more than 2450” letters advising individuals of incomplete applications, whose processing will be delayed as a result.

Two weeks ago (October 23), the American Society for Microbiology (ASM), fearing a disruption in the nation's bioterror research capacity if researchers who had not been cleared were barred from their labs, requested that the Secretaries of Agriculture and Health and Human Services push back the November 12 deadline to give the FBI time to finish its work. “We're relieved,” past ASM President Ron Atlas told The Scientist. “It meets what we asked for in the letters.”

But the ASM's letter was not what drove the CDC to amend their rule, said Jones. Instead, the impetus for the amendment came in early September, when CJIS informed the CDC that they would not be able to complete all the security risk assessments by the November 12 deadline.

The select agent rules implement part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The act, Jones said, stipulates that the regulations should not impede the nation's research and education efforts. As a result, researchers working with select agents prior to February 7, 2003, when the law went into effect, have been allowed to continue working while the new rule is implemented. The new amendment basically maintains the status quo.

The select agent regulations will still go into effect November 12. Jones said that provisional certificates would be mailed sometime afterward. These certificates will remain valid until the FBI completes its assessments, at which time the CDC or the USDA will either issue a full clearance or revoke the temporary one.

“I assume that for various institutions, this is a momentary sigh of relief,” said ASM's Atlas.