Lawmakers Chide Agencies’ Oversight of Pathogen-Handling Labs

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By Greg Langlois

A dual-agency federal program charged with securing dangerous pathogens such as anthrax and smallpox in laboratories across the country got slammed again by a House subcommittee Nov. 2.

Lawmakers questioned why the Federal Select Agent Program (FSAP) has struggled to tighten its oversight of research labs that handle hazardous biological substances designated as select agents after repeated security incidents and congressional inquiries. FSAP leaders appeared at the House Energy and Commerce Subcommittee on Oversight and Investigations hearing after a critical report came out two days earlier.

“This goes on and on, and it’s something this subcommittee has to revisit over and over again,” said Rep. Diana DeGette (D-Colo.), the subcommittee’s ranking member. “At some point something very bad is going to happen.”

FSAP is jointly managed by the Centers for Disease Control and Prevention, part of the Department of Health and Human Services, and the Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS). The subcommittee cited a number of concerning episodes in a memorandum issued ahead of the hearing, including the exposure of dozens of CDC lab employees to anthrax and cross-contamination involving the H5N1 flu virus at another CDC lab.

“We’ve kind of been here before,” said Rep. Greg Walden (R-Ore.), chairman of the full committee. “Every two or three years, we get a GAO report, the subcommittee has a hearing, we all come and say appropriate things and then we wait another two or three years and then have another hearing. Maybe this time it’s different.”

GAO: Declare Independence

FSAP still doesn’t meet requirements for effective oversight, according to the report, issued by Congress’ investigative arm, the Government Accountability Office. Among other things, it needs to make sure it conducts oversight at arm’s length from labs it oversees, GAO said.

Because many of the labs CDC and APHIS inspect are within their own agencies, conflicts of interest could potentially affect FSAP’s work, the GAO report said. The agencies agreed in 2012 APHIS would lead inspections of CDC labs, but Rep. Morgan Griffith (R-Va.), vice chairman of the subcommittee, questioned why it took three years for them to make the arrangement reciprocal.

APHIS wasn’t sure it had the authority to allow the CDC to oversee certain USDA labs because they contained USDA-only agents, said Freeda Isaac, director of APHIS’s Agriculture Select Agent Services. The agency’s legal staff eventually determined it could do so as long as the FSAP agencies jointly signed inspection reports, she said.

“I do find it curious that we had a [memorandum of agreement] in place,” Griffith said, but that it took APHIS three years to decide whether the CDC could lead inspections of its labs.

APHIS has led at least three inspections of USDA labs, including one run by APHIS, even since the 2015 change, the GAO report said.

“I think the ability to have independent and integrated investigations is really important,” DeGette told Bloomberg Law after the hearing. “It’s kind of puzzling why we still don’t have that.”

Risky Business

FSAP also needs to figure out the riskiest activities special agent-handling labs engage in and have inspectors focus there, according to the GAO.

“They really need to look at the highest-risk activities and make that formal determination,” said Mary Denigan-Macauley, acting director of the GAO’s health care division. “While some steps have been taken, it has not been a full, formal assessment to best understand what those activities are.”

A strained inspector workforce also endangers FSAP’s work, she said. The CDC and APHIS have difficulty hiring and retaining inspectors, which forces some to venture outside of their areas of expertise, she said.

The CDC has 51 inspector positions available to fill, said Samuel Edwin, director of the CDC’s Division of Select Agents and Toxins. Most of its inspectors are hired from select agent labs, about 65 percent have doctorate degrees, and the rest have master’s degrees, he said.

“We do have that intellectual capital,” Edwin said.

Next Steps

Subcommittee members floated possible legislative fixes, including creating a fully independent agency to oversee special agents. Committee Chairman Barton questioned why so many labs conduct research on special agents—276, according to the GAO report—and Rep. Buddy Carter (R-Ga.) asked whether any pathogens and toxins currently designated as special agents should be removed from the list.

The list is reviewed every two years by a working group from different agencies, Edwin and Isaac said.

The GAO didn’t provide legislative ideas in its report.

“We looked at the program in its current form, so we didn’t weigh in on the potential for whether new legislation is needed but we certainly have provided enough information” for the committee and regulators to consider, Denigan-Macauley told Bloomberg Law after the hearing.

Both the CDC and APHIS agree with the recommendations in the GAO report and will implement them, Edwin and Isaac said.

To contact the reporter on this story: Greg Langlois in Washington at glanglois@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

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