Top U.S. lab regulator replaced in wake of incidents with bioterror pathogens

USA Today – by Alison Young

The Centers for Disease Control and Preventionhas replaced its longtime director of national lab regulation in the wake of several high-profile incidents involving bioterror pathogens and an internal review that identified areas of improvement for the oversight program, USA TODAY has learned.

The CDC, in a statement Tuesday, declined to say why it replaced Robbin Weyant on Nov. 9 as director of the agency’s Division of Select Agents and Toxins, which regulates hundreds of U.S. labs working with the organisms that cause anthrax, plague, Ebola and other deadly diseases that are deemed to pose bioterror risks.  

The change occurred 18 days after the completion of an internal CDC review of the national lab oversight program that was launched after a USA TODAY NETWORK investigation prompted congressional probes and revealed CDC’s inspectors have allowed labs to keep experimenting despite failing to meet key safety requirements on inspection after inspection, sometimes for years.

Weyant had served as select-agent director since 2006, according to his LinkedIn profile, and he now lists his current job with CDC as a senior adviser in the agency’s newly created lab safety office. Weyant also declined to comment on his job change.

In a statement, Rep. Fred Upton, R-Mich., chairman of the House Committee on Energy and Commerce, and Oversight & Investigations Subcommittee Chairman Tim Murphy, R-Pa., said: “We’ll be taking a close look at CDC’s actions and are disappointed the agency did not consult with the Committee prior to its announcement. Strong and effective management of the select agent program is our top priority, and we want to know whether this signals deeper problems that CDC has not yet disclosed. Our important work continues.”

Some biosafety experts have complained that the oversight of “select agent” labs has focused too much on paperwork reviews and bureaucratic minutiae, rather than meaningful measures of safety and security. Select agent is the government’s term for certain viruses, bacteria and toxins that are subject to regulation because they have the potential to be used as bioweapons.

“This is a great opportunity for leadership to make much needed changes in the implementation of the Select Agent Rules,” David Franz, a former commander of the U.S. Army Medical Research Institute of Infectious Diseases in Maryland, said in an email. “With a right approach [CDC regulators] could minimize the damaging drag that the creeping bureaucracy has placed on progress within the enterprise in recent years and actually enhance lab security and safety.”

The USA TODAY NETWORK’s ongoing investigation has raised questions about whether lax oversight and enforcement by the CDC played a role in allowing the Army’s biodefense facility at the Dugway Proving Ground in Utah to mistakenly ship live anthrax for more than a decade to dozens of labs in the U.S. and abroad. The lax procedures at Dugway’s labs were discovered only in May after a private biotech company happened to test an anthrax specimen it received from the Army as part of a project to develop a new diagnostic test. Despite having a certificate from Dugway saying the anthrax had been killed with radiation, the company found it was alive and capable of growing.

USA TODAY reported in June that the CDC in 2007 referred the Dugway lab 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 when it used radiation to kill anthrax research specimens.

The CDC’s report of its internal review of the oversight program, dated Oct. 22, identified several areas for improvement, including the need for regulators to better characterize risks on inspection reports, then prioritize and strengthen enforcement actions for the highest-risk violations.

The CDC has named Dan Sosin as acting director of its select-agent division, according to a Nov. 17 email, obtained by USA TODAY, that the agency sent to lab officials. Sosin previously was deputy director of CDC’s Office of Public Health Preparedness and Response.

The CDC would not answer any questions about the change in leadership or whether Sosin’s appointment will be permanent. The agency, in a statement, would say only that Weyant is now working “as a senior advisor with our newly formed Office of the Associate Director for Laboratory Science and Safety to add his extensive expertise in lab safety and security to our ongoing improvement efforts.”

Follow USA TODAY investigative reporter Alison Young on Twitter: @alisonannyoung

http://www.usatoday.com/story/news/2015/12/08/cdc-bioterror-lab-regulator-replaced/76976554/?hootPostID=883dc8ef41c8a54e01273a0e2f8f75f9

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