Labs cited for 'serious' security failures in research with bioterror germs

by Alison Young, USA Today, August 29, 2015 (excerpts)

Amid concerns about the potential of a laboratory insider unleashing a deadly bioterror pathogen on the public, President Obama ordered greater scrutiny of workers with access to the riskiest microbes five years ago. The goal of the resulting regulations was to prevent something like the 2001 anthrax letter attacks — or worse — from happening again.

Federal regulators have secretly threatened to revoke permits to study bioterror pathogens from at least six labs — including those operated by Brigham Young University in Utah, the University of Hawaii-Manoa and the California Department of Public Health — because they failed to take required actions to assess the behavior and trustworthiness of their workers, plus other kinds of safety violations, records obtained by USA TODAY show.

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The University of Hawaii-Manoa was called out by regulators, in another letter the government and the university tried to keep secret, for “widespread regulatory non-compliance” and "a serious disregard" for regulations for security, biosafety, incident response and training. Issues included failures to implement suitability assessments of key lab staff, installing a security system but not making it operational, and having lab staff that didn’t understand how to use respiratory protection needed to prevent exposure to infectious agents.

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University of Hawaii-Manoa: A May 2014 letter from the CDC to the university said findings on inspections had “indicated a serious disregard for these regulatory requirements resulting in observed compliance departures in the security, biosafety, incident response, and training requirements of the select agent regulations.”Regulators said the university had “serious regulatory deficiencies” that included failure to implement procedures for pre-access and ongoing suitability assessments of lab workers with access to Tier 1 pathogens. Though the university had installed the hardware for a required intrusion-detection system in Tier 1 pathogen areas, the university "has failed to render this system operational,” the CDC wrote.

Regulators expressed concerns about “serious biosafety departures,” including “misunderstandings” among staff on the proper use of respiratory protection against exposure to pathogens. Such issues, the letter said, “can result in increased risk of exposure to infectious agents by entity personnel that are not properly equipped or do not understand the use of the respiratory protection provided.” The letter said the CDC “strongly recommends” the university cease all work with Tier 1 select agents and enter into a storage-only status until it completed a federal performance improvement program.

University officials declined to be interviewed and did not answer most of USA TODAY’s questions. In an email, spokesman Daniel Meisenzahl said the university “fulfilled all requirements of the performance improvement plan,” and  the CDC renewed the university’s registration in June to allow work with select agent pathogens through June 2017. “This is an example of government functioning properly with [CDC’s] continuing vigilance toward constant improvement,” he said.

The university has refused since last year to release records to USA TODAY about its select agent violations and enrollment in the PIP. In response to USA TODAY’s open records appeal to Hawaii’s Office of Information Practices, the university told the information office in January that it is “proud” of being put on the PIP and that it “has been an exemplary participant in the Federal Select Agent Program.”

Hawaii State Sen. Sam Slom, a University of Hawaii alum and legislative watchdog over the school, said Wednesday that although some secrecy may be warranted, “I think we overuse that as an excuse.” He said he’ll ask tough questions when the Legislature begins its 2016 session in January and discusses the university's state funding.

“They look at being under the PIP as a point of honor, as if they’ve done something right — which is wrong,” said Slom, the Legislature’s minority leader and lone Republican. “My point of view is if you have serious regulatory issues here, particularly that involve public safety, you tell the university: Here’s your funding request. We’ll hold it until you adequately answer questions.” ....

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