In the wake of repeated blunders involving the handling and shipment of live anthrax, the Centers for Disease Control and Prevention is launching a “comprehensive review of how it regulates safety and security at bioterror labs,” The USA Today reports.
House Energy and Commerce Committee Chairman Fred Upton (R-MI), Ranking Member Frank Pallone, Jr. (D-NJ), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), and Subcommittee Ranking Member Diane DeGette (D-CO) commented, “We hope this latest review signals that the agency is finally taking this issue seriously. While we applaud CDC’s intent to investigate this matter, previous assessments have failed to meaningfully address the root causes of why these safety lapses keep happening. We look forward to hearing more from the CDC next Tuesday and will continue our efforts to hold the administration accountable until real changes are made in its handling of these dangerous pathogens.”
Committee leaders have sent a number of letters in the wake of reports of live anthrax shipments from the Department of Defense laboratory at Dugway Proving Ground and last summer held hearings regarding the handling of live anthrax in Ziploc bags. Next Tuesday, the Subcommittee on Oversight and Investigations will hold a hearing, “Continuing Concerns with the Federal Select Agent Program: Department of Defense Shipments of Live Anthrax.” Witnesses from the Department of Defense, Centers for Disease Control and Prevention, Department of Health and Human Services Office of the Inspector General, and Government Accountability Office will testify.
July 21, 2015
CDC to Review Oversight of Bioterror Labs after USA TODAY Investigation
The Centers for Disease Control and Prevention is launching a comprehensive review of how it regulates safety and security at bioterror labs in the wake of an ongoing USA TODAY Media Network investigation that has prompted congressional probes into the agency’s effectiveness.
CDC Director Tom Frieden ordered the review last week as USA TODAY prepared to report on newly obtained documents showing that the agency’s inspectors have allowed labs to keep experimenting with bioterror pathogens despite failing to meet key requirements on inspection after inspection, sometimes for years. The action also comes as the agency faces a hearing in the House next week.
“This review will be wide-ranging and includes a review of regulatory authority and the exercise of that authority so that we can identify potential modifications to the methods used to inspect labs,” the CDC said in a statement this week.
The review, which is expected to take 90 days, will be directed by Stephen Redd, director of the CDC’s Office of Public Health Preparedness and Response, the CDC said.
Next Tuesday, a subcommittee of the House Energy and Commerce Committee plans to hold a hearing on the CDC’s oversight of select-agent labs, with an emphasis on recent shipments of live anthrax from a Department of Defense facility in Utah. Committee leaders were not immediately available for comment.
Earlier this month, citing USA TODAY’s reporting, the bipartisan leaders of the full committee and its investigations subcommittee sent letters to the CDC and enforcement officials at the Department of Health and Human Services inspector general’s office demanding they provide the names of research labs that have faced sanctions for safety violations as well as other information about select-agent oversight.
“Select agent” is the federal government’s term for viruses, bacteria and toxins with the potential to be used as bioweapons or that pose significant risk to agriculture or public health.
A USA TODAY Media Network investigation published in May uncovered hundreds of accidents that have occurred in biological laboratories nationwide in recent years and revealed that pervasive secrecy obscures failures by regulators to ensure research facilities operate safety and don’t unduly put workers and the public at risk. The network’s reporting has prompted questions about the CDC’s regulation of labs from the bipartisan leaders of the Senate Homeland Security and Governmental Affairs Committee.
The network’s ongoing investigation has raised questions about whether lax oversight and enforcement played a role in allowing an Army biodefense facility to mistakenly ship live anthrax for more than a decade to dozens of labs in the U.S. and abroad. USA TODAY reported in June that the CDC in 2007 referred the Army’s Dugway Proving Ground facility for potential federal enforcement action for failures to deactivate live anthrax with chemicals and for ignoring tests indicating the kill process was ineffective. But no fines were levied, and over the years CDC’s inspectors apparently never detected that similar failures continued at Dugway in its routine use of radiation to kill anthrax.
More than 100 labs experimenting with potential bioterror pathogens have faced enforcement actions — some repeatedly — since 2003 from the Federal Select Agent Program, which is jointly run by the CDC and the U.S. Department of Agriculture. The government keeps their names secret, citing a federal bioterrorism law, and even refuses to disclose the names of labs kicked out of the program.
USDA officials could not be immediately reached about whether that agency also is reviewing how it regulates the labs it oversees, which focus on pathogens that primarily threaten agriculture, plants and animals.
Since January, USA TODAY has sought records, using the Freedom of Information Act (FOIA), from the CDC and USDA about their use of performance improvement plan programs — or PIPPs — as an alternative to suspending or revoking a failing lab’s authorization to experiment with bioterror pathogens.
The USDA identified 479 pages of records involving letters to labs notifying them they were being put on a PIPP but in March refused to release any of them, citing a secrecy provision in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. USA TODAY has appealed.
The CDC recently responded to a similar FOIA request by sending USA TODAY 91 pages of correspondence with various labs about their enrollment or removal from performance improvement plans from 2011 to 2014. The CDC redacted all of the labs’ names — as well as the names of pathogens involved in their safety violations. USA TODAY has appealed the redactions.
The records show that labs experimenting with bioterror pathogens have failed over and over to comply with important safety and security regulations — yet CDC inspectors have allowed some of them to continue operating for years before offering to put them on PIPPs. When inspectors identified significantly lax safety or security practices in work with “Tier 1” select agents, the CDC’s letters said only that the agency “strongly recommends” the labs stop work with the pathogens, without mandating it.
Tier 1 select agents are those that federal officials deem to pose the “the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure or public confidence, and pose a severe threat to public health and safety.” They include such deadly pathogens as the Ebola virus, anthrax and botulinum neurotoxin.
It’s unclear whether the CDC’s approach to oversight is a result of a lack of authority. The agency did not respond to USA TODAY’s questions since last week about issues raised by the documents. …
Read the complete article online HERE.