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The nation’s systems for inspecting, monitoring, securing and transporting biotoxic agents are badly in need of streamlining, according to a just released report from the Working Group on Strengthening the Biosecurity of the United States.
“The responsibility for oversight of select agent entities by various Federal, State, and local agencies beyond HHS and USDA has become overly diffuse,” the report claims, “ resulting in numerous uncoordinated inspections with non-uniform standards, expectations, and interpretations.”
The report
, ordered by the Bush administration during its final weeks in office on January 9, 2009 by Executive Order (EO) 13486 entitled “Strengthening Laboratory Biosecurity in the United States” found that the current list of 82 bio-agents requiring monitoring was overly broad including many agents of low or no risk.
The Working Group (WG) was co-chaired by the Secretary of Defense and the Secretary of Health and Human Services, or their designees. Other members of the WG included designees
of the Secretaries of State, Agriculture, Commerce, Transportation, Energy, and
Homeland Security, the Directors of National Intelligence and the National Science
Foundation, the Administrator of the Environmental Protection Agency, and the Attorney General.
The Working Group recommends that the US government “perform a risk assessment for each select agent and toxin on the Biological Select Agents and toxins (BSAT ) list and develop a stratification scheme that includes biodefense and biosecurity criteria, as well as risk to public health, so that security measures may be
implemented based upon risk.”
In addition the report urges the government to enhance coordination of oversight
and inspections as well as institutional implementation, compliance, oversight, and
accountability, and provide comprehensive guidance on inventory management and
recordkeeping requirements, approaches, and templates.
The report also cited a lack of personnel security at Biolabs handling BSAT.
“Improvements can be made in the current Select Agent Program regarding
the screening of individuals both prior to granting access to BSAT and after access has
been granted,” it said.
To rectify this laxity the working group recommends enhances security risk assessment at the Federal level to “allow for improved vetting of U.S. citizens and foreign nationals.” This will require, according to the report, continuous monitoring measures (supervisor accountability, self- and peer-reporting) at the local level and evaluate the feasibility of reporting of derogatory information to improve management oversight of individuals with BSAT access.
The study further warns that currently there are no uniform minimum prescriptive standards for physical security at facilities that handle, store, or transport BSAT, recommending. The development of a set of minimum prescriptive security standards based on the
risk at the lowest level, allowing for enhancements as risk increases.
Although historical data indicate that there has been only one confirmed loss of a
BSAT shipment in the last twenty years, and none from criminal activity, that greater proactive measures to ensure safety in the transport of BSAT are necessary.
While the lack of criminal interference in BSATY transport so far may suggest that existing regulations, policies, and procedures are satisfactory, the report cautions, “there has not
been an extensive assessment to determine the threats, vulnerabilities or risks within this
sector regarding BSAT.
To rectify this the working group urges a risk assessment, focused on the security of BSAT
transportation under the current regulatory framework, to determine if any risk is present
during BSAT transportation.
In conclusion the report found that “the Select Agent Program has significantly strengthened the biosecurity of the United States since its implementation.
It adds, however, that “biosecurity could be further enhanced and strengthened at the Federal and local levels.”
Phil Leggiere
About the author:
Business Editor/Online Managing Editor, is an experienced journalist and business analyst based in New England.