Watchdog Demands Report on Lab Troubles

by Julie St. Louis, Court House News, January 15, 2016

HONOLULU (CN) - A Freedom of Information Act lawsuit may finally force the Centers for Disease Control and Prevention to release information about the safety of University of Hawaii-Manoa's bioscience building - at least that's the hope of Civil Beat Law Center for the Public Interest, which filed the suit in Hawaii Federal Court on Jan. 7.

After media outlets reported that the CDC found "widespread regulatory noncompliance" in the university's labs that use biological agents and toxins in 2014, the watchdog asked for a copy of the agency's report.

But the CDC withheld the report entirely, despite permission given by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 that the agency may withhold only portions of its investigations, the watchdog claims.

"By refusing to disclose redacted records, CDC violated the careful balance struck by Congress between transparency and security," the organization says in its complaint.

The group also claims that information about the use of "select agents at UH is readily accessible in the public domain," negating CDC's claim that even portions of those records would endanger public health and safety.

The university has an operational Bio-Safety Level-3 and an Animal Bio-Safety Level-3 biocontainment facility in the bioscience building of the John A. Burns School of Medicine in Kaka'ako. Among the many agents researched are botulinum neurotoxins, Ebola viruses and the neurotoxin Tetrodotoxin.

The safety concern over Hawaii's only facility of this kind - for researchers and the nation - was first brought to light through a 2015 USA Today expose.

USA Today got its on a May 2014 letter from the CDC to the university telling them of "serious regulatory deficiencies" that included failure to implement procedures for pre-access, and discussing "a serious disregard for regulatory requirements.

"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," and that the CDC "strongly recommended" 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.

After the USA Today expose, university officials released an email statement that 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."

University officials did not respond to email requests for comment.

Civil Beat Law Center for the Public Interest seeks an order compelling the CDC to release the requested documents.

The group is represented by R. Brian Black, who is also its CEO and executive director, who did not respond to an emailed request for comment.

Civil Beat Law Center for the Public Interest is located in Honolulu and is "dedicated to advancing the public's rights by investigating questionable government activity, advocating for corrective action, and, if needed, enforcing corrective measures in the courts," according to its website.

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