Few public health labs will handle high-risk pathogens after new rules take effect

After tougher security requirements take effect in April, few state public health laboratories plan to maintain stocks of Tier 1 select agents and toxins, according to a recent informal survey.

Starting on April 3, labs that want to keep Tier 1 agents, such as Ebola virus and the anthrax-causing Bacillus anthracis, must meet special security and screening rules on top of the ones already required by the Select Agent Program. The survey was conducted by the Association of Public Health Laboratories and officials with state laboratories, CIDRAP News reports.

"We did a quick survey, and what we've seen so far is only about six of our labs indicated they'd have an interest in pursuing Tier 1 registration," Chris N. Mangal, the director of public health preparedness and response for the APHL, said, according to CIDRAP News.

Laboratories participating in the Department of Health and Human Services Select Agent Program were told to notify the HHS last week if they planned to seek registration for Tier 1 agents. They must get rid of their Tier 1 samples by April if they decide not to register. After the rules take effect, the labs may still conduct initial testing of Tier 1 agents but must destroy or ship the sample within one week.

"I don't believe that the Tier 1 select agent requirements will limit their (labs') ability to perform the initial testing for threat agents," Mangal said, according to CIDRAP News. "Where this new regulation becomes a problem is the additional characterization that is typically needed for evidentiary purposes."

Joanne Bartkus, the director of the Minnesota Department of Health's Public Health Laboratory in St. Paul, resents the new rules regarding Tier 1 agents. Her lab plans to seek registration.

"We felt it was important to maintain the capability to work with these agents," Bartkus said, according to CIDRAP News. "We felt that keeping the bugs for a week is not really long enough. If we don't maintain that capability, it's gone, possibly forever. So we've been assessing the regulations, and we have a project plan in place to fill any gaps. We feel it's doable."

Other Tier 1 agents include the causes of tularemia, Marburg virus, smallpox, plague, botulism, glanders and melioidosis.