'Select agent' clearances delayed

US agencies have completed only about half of inspections as Nov 12 deadline looms

Oct 29, 2003
Jeffrey Perkel(jperkel@the-scientist.com)

Critical national biodefense research could be delayed starting November 12, according to the American Society for Microbiology (ASM), unless the federal government delays implementation of new regulations intended to boost security of dangerous biological agents and toxins. However, federal agencies, scrambling to keep up, said the problems are being addressed.

In a pair of letters dated October 23, the ASM requested that the secretaries of Health and Human Services and Agriculture push back the effective date for full compliance with Title II of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002—currently November 12—to give the government more time to vet researchers who wish to work with select agents and to inspect the laboratories in which such work will be performed.

Once Title II, the so-called "select agent rule," is fully implemented, any researcher who has not been cleared to work with select agents will be barred from working in labs that contain these materials. But according to the letters, the vast majority of screens have not yet been completed. Thus, a failure to delay implementation by November 12, the letters said, "will cause the delay and/or abandonment of scientific research that is important for homeland security and for the general welfare of the American people."

Laboratories and individual researchers have been dealing with the implementation process for nearly 9 months now, since Title II—which governs research into a list of 80 or so pathogenic bacteria, viruses, and toxins—went into effect on February 7. Laboratories had to register with the Centers for Disease Control and Prevention (CDC) and/or the US Department of Agriculture (USDA) by March 12. Individual researchers, meanwhile, had until April 12 to register with the Federal Bureau of Investigation (FBI). These agencies were then to perform a series of background checks and safety and security inspections.

The FBI reviews were to have been completed by June 12. But the FBI Criminal Justice Information Services Division, which is charged with performing the background checks, completed only "a little over 4000" of an estimated 8000 requests received, according to Monte McKee, chief of the agency's investigative and operational assistance unit.

One problem that slowed the checks was that applicants were not required initially to submit all the necessary paperwork—both a fingerprint card and an FBI information form—together, resulting in nearly 2600 incomplete applications. "It takes a long time to crank out 2600 letters telling people we need more information," McKee told The Scientist.

McKee said he could not comment on how many of those applications were favorably completed and how many were denied. But he estimated that 11 new permanent staff members hired to start on November 3 and assigned to these background checks can process 500 applications per month, so the remaining 4000 applications could take up to eight months to complete.

"Potentially, you shut and lock the doors of the laboratories on November 12 if the clearance process has not been accomplished," Ronald Atlas, past ASM president and one of the letters' four signatories, told The Scientist. As for the ongoing experiments, cultures, and infected animals left inside, Atlas added, "You could potentially put them on one side of a door, and no one legally allowed to enter."

Atlas emphasized that the ASM "strongly supported and continues to support" biosecurity regulations that ensure that individuals given access to select agents have been cleared by the FBI. "The government needs to move forward in the next couple of weeks and clear the people that need to be cleared, or they need to take into account that they couldn't do that and extend the deadline until they can."

The letter's other signatories were Thomas Shenk, ASM president; Kenneth Berns, chair of the ASM Task Force on Biological Weapons; and Gail Cassell, chair of the ASM Public and Scientific Affairs Board.

The ASM's fears could be moot, however. Ted Jones, acting director of the CDC select agent program, told The Scientist that those labs whose paperwork is in order but that have not yet been inspected would be given permission to continue working after the November 12 deadline. "We're not going to hold up an approval if their application is in order." Over 400 entities have registered with the CDC under the Select Agent Rule, of which "more than 180" have been inspected, Jones said. He noted that no certificates have yet been issued, but that the process would begin "within the next couple of weeks." Jones expected the inspection process would be completed by April 2004.

A USDA spokesperson likewise said that labs wishing to work with select agricultural agents could receive a certificate of registration without inspection. The registration is valid for 3 years, the spokesperson noted, during which time the inspection would occur.

However, there i's some confusion as to what will happen if a lab is certified for select agent work after the implementation date, but the lab workers await FBI clearance. "There's work going on in that regard," said CDC's Jones.

Richard Rest, professor and director of the Biodefense Research Laboratory, Department of Microbiology and Immunology, Drexel University College of Medicine, said his lab and employees have already completed the certification and approval process. Rest's lab, a biosafety level (BSL) 2 facility, underwent renovations prior to the CDC inspection. He installed bars on the windows, continuous video monitoring, and a new keyless entry system.

Rest told The Scientist he was "pleasantly surprised" at the CDC and FBI agent's helpfulness and responsiveness during the application and review process—a sentiment echoed by Alison O'Brien, professor and chair of microbiology and immunology at the Uniformed Services University of the Health Sciences, who has also undergone the inspection and approval process.

But Rest added that the lengthy approval process and the rules of compliance add a new level of complexity and cost to lab management. Rest's group studies two organisms—Bacillus anthracis, which is a select agent, and Neisseria gonorrhoeae, which is not. Though the bulk of Rest's funding and effort revolves around N. gonorrhoeae, he had to clear his entire team—a total of 10 individuals, including himself—for work with anthracis, because both organisms are used in the same lab. It took between 3 and 4 months for the clearance checks to come through, he added.

The new rules, he said, make it difficult to have temporary workers—undergraduates, rotating students, or summer students, for instance—in the lab and also complicate the hiring process for technicians and postdocs. "You can't say, take these papers, fill them out, and call me in 3 months," he explained. "It's got to be faster."

Rest is now renovating his space so that he will have separate BSL2 and BSL3 facilities, the latter reserved for select agent research. This way, he says, when new people join the lab, at least they can do research while they wait for clearance.

New hires aren't the only ones waiting around for approval letters. At a recent meeting of the newly formed Mid-Atlantic Regional Center of Excellence for Biodefense and Emerging Infectious Disease Research, a multimillion dollar National Institutes of Health–funded consortium, Rest said, biosecurity was very much on peoples' minds. One of the big concerns, he said, was "Will the investigators and universities be certified and approved in time to do the work? There's no question, they won't be."