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Security Mandates Seen as Burden to U.S. Lab Preparedness
U.S. medical laboratories might opt out of the nation's select agents program to avoid the burden of new security mandates, a possibility that could result in a loss of key capacities for handling a deliberate or natural pathogen outbreaks, an organization representing such sites indicated in a report last Wednesday by the Center for Infectious Disease Research and Policy.
The fresh security requirements are being imposed on facilities housing any of 11 high-risk biological materials,
The Centers for Disease Control and Prevention last week said scientific institutions would have 180 days to implement the newly required protections if they hold any of the newly designated "Tier 1" agents, which include anthrax, Ebola, Marburg virus and plague.
The new rules prompted a statement of concern by Chris Mangal, head of public health preparedness and response for the Association of Public Health Laboratories.
Because the new Tier 1 list includes anthrax, "a lot if not all of our state public health labs will be impacted by the new requirements that come along with Tier 1," Mangal said.
CDC officials rejected a call by Mangal's organization to grant an exemption to the rules for facilities in the Laboratory Response Network, an initiative aimed in part at supporting coordination between U.S. laboratories responding to an act of bioterrorism.
The Health and Human Services Department office also dismissed a group recommendation to exclude from the Tier 1 rules a noncommunicable variety of anthrax as well as botulinum toxin and botulinum bacteria; LRN facilities hold samples of the material to aid in verifying potential environmental findings.
The noninfectious anthrax type could generate a dangerous version of the bacteria in conjunction with another variety not subject to the Tier 1 standards. Emerging findings would prompt further CDC assessments of exemption proposals, the agency indicated.
Separately, CDC Select Agents and Toxins Division Director Rob Weyant said his agency "has been working with the leadership of the LRN to identify excluded strains of select agents that can be maintained by laboratories without meeting the Tier 1 requirements."
Such nonvirulent samples could support verification activities, but facilities outside the select agents program would still have to eliminate or transfer any discovered Tier 1 material sample within a week, Mangal said.
"From a scientific perspective, you may not want the lab to destroy the agent until they've had an opportunity to further characterize it and get more genetic details," Mangal said. "We don't want to promote (the practice) that once you've identified an agent you destroy it within seven days."
The expert identified new federal requirements for personnel background probes as the chief source of worry for her organization.
"The main added requirement on this is the entity is now required to perform a pre-access suitability assessment," Mangal said. "They (staff) already go through a background check with the Department of Justice. This is more of an entity-specific assessment. "
She added her organization would assess guidelines prepared on the matter by CDC officials.
"In coming months I anticipate significant discussion within the public health lab community as to whether to maintain their select agent registration," Mangal said. "There's obviously value in maintaining it -- there are security standards that come with that that help prevent access to select agents -- but what the labs will have to look at is what are the costs to meet the new Tier 1 requirements, and what are the ongoing costs."
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