Biosecurity Panel Findings Sent to U.S. Cabinet Officials for Approval
Friday, Nov. 19, 2010WASHINGTON -- The findings of a presidentially mandated panel assigned to identify the most dangerous disease agents and offer strategies to boost safeguards at research facilities that house them have been presented to senior administration officials, Global Security Newswire has learned (see GSN, July 6).
(Nov. 19) - A Centers for Disease Control and Prevention scientist works at a Biosafety Level 4 laboratory. A federal panel established to offer strategies for boosting security at facilities that work with dangerous disease agents has delivered its findings to several Cabinet members (Centers for Disease Control and Prevention photo).
The product of the Federal Experts Security Advisory Panel was delivered to the Agriculture and Health and Human Services secretaries and the attorney general for their signatures, according to George Korch, acting principal deputy to the HHS assistant secretary for preparedness and response, who co-chaired the panel.
"We have asked for this process to proceed as quickly as possible," he told GSN by e-mail this week.
Once signed, the panel's recommendations will be made available to the public and sent to the federal Select Agent Program, which oversees the government's register of disease agents and regulates laboratories that possess, use, or transfer those materials within the United States.
The timing of the release will coincide with a biennial review of the policies that govern the select agent list, he added. That process, required by the 2002 Agricultural Bioterrorism Protection Act, kicked off in August with a Federal Register notice.
Lawmakers wanted the list reviewed every two years so it would be "relevant to the potential public health risks or threats," according to Kavita Berger, associate program director at the American Association for the Advancement of Science's Center for Science, Technology and Security Policy.
"If it's a stagnant list, that doesn't ever change, but your threat or your risk change ... you can modify your list to make sure that those pathogens that are of high-risk, in particular, would be covered," she said today in a telephone interview, adding that most human and animal pathogens have not come off the inventory.
Any panel recommendations that would require alterations to the program's regulations would be considered in the biennial review, along with public comments generated by the notice, according to Korch.
The assessment is slated to wrap up around the end of 2011, a spokesman for the Centers for Disease Control and Prevention told GSN last week. That organization, and the Agriculture Department's Animal and Plant Health Inspection Service, administer the select agent list.
Today there are 82 listed select agents, pathogens and biological toxins declared to pose a severe threat to human or animal health. More than 400 U.S. research entities are registered to work with select agents and roughly 15,000 individuals are cleared for access to the materials that include anthrax, smallpox and the Ebola virus.
The expert panel, which includes representatives from the State, Defense, Commerce, Transportation, Energy and Homeland Security departments, was established though an executive order given this summer by President Obama.
The order was issued to address growing concerns about U.S. biosecurity policy and procedures. An influx of funding for biodefense activities over the last decade has produced worries about the ever-increasing number of facilities and personnel carrying out research with potentially lethal disease materials.
The document instructed the Agriculture and Health and Human Services departments to, over an 18-month period, prepare a list of high-risk, or "Tier 1," materials that present "the greatest risk of deliberate misuse with most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence." That work continues.
The departments would ultimately assess options for the "targeted application of physical security and personnel reliability measures" for the agents and toxins placed in the highest risk tier, according to an accompanying White House fact sheet. Personnel reliability programs are often used to evaluate whether an individual is trustworthy enough to work with sensitive material or technology.
The July 2 order also instructed the two agencies to consider reducing the overall number of disease materials on the select agent list.
The expert group was established to serve as the Select Agent Program's lead security advisory body, providing guidance on the stratification or reduction of the disease list; best practices for physical security and personnel reliability; and other issues as determined by the two departments.
Overall, the panel's consensus recommendations "are a mixture of regulatory changes, policy changes and suggestions for guidance to be provided to registered entities," according to Korch. "Over the next 18 months, the Select Agent Program will be engaging stakeholders within the government and the public to develop and implement new regulations and guidance to achieve improved biosecurity, while supporting a robust biodefense enterprise."
He said the timing of the recommendations was "for the benefit" of the Select Agent Program so that its administrators could "have enough time to incorporate them into their rulemaking process if they so choose."
Korch said the executive order gives the program 15 months from July 2 to propose amendments to the regulations establishing security standards for Tier 1 materials, which would ostensibly be a subset of the select agent list.
The effort then has another three months to finalize the requested list of Tier 1 agents, consider reducing the select agent list and offer options for "graded protection" commensurate with the risk posed by the material.
The program has an additional 11 months after that to promulgate "final rules and guidance" for those designated materials, ending the process in the latter half of 2012.
Experts from the 13 agencies represented on the advisory panel will be available to work on implementation with the Centers for Disease Control, according to Korch.
There is "a lot of talking going on" within the academic and biological research communities about the unreleased recommendations, according to Berger.
She said that although some have advocated for the select agent list to be tiered and matched with appropriate security measures, other institutions argue they have already implemented the government's previous requirements and any proposed change to the list now might prove a financial burden.
Yet representatives for many research institutions have said the mandate for the experts panel "looks promising" and could provide "better guidance on what to do and how to do and not add any additional burdens," she told GSN.
"The question is when they come out with their recommendations, will they be something that will be feasibly implemented at research institutions and will their policies really minimize the amount of human and financial resources needed to just comply with all the different agencies involved," Berger said.
Friday, November 19, 2010
NTI: Global Security Newswire - Biosecurity Panel Findings Sent to U.S. Cabinet Officials for Approval
via gsn.nti.org
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