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Chapter 33 : Biosafety and Biosecurity: Regulatory Impact

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Abstract:

The Anti-Terrorism and Effective Death Penalty Act of 1996 was passed by Congress after the Larry Wayne Harris incident to control the transport and receipt of hazardous biological agents. The law directed the U.S. Department of Health and Human Services (DHHS) and Centers for Disease Control and Prevention (CDC) to establish new regulatory requirements governing the receipt and transfer of those etiologic agents classified as select agents. In addition to biosafety requirements, the regulation specifies compliance parameters for site threat assessments, inspections, access, training, registration, transfer, record keeping, physical security provisions, and incident reporting, to include notification of loss, theft, or release of agent. Microbiological and Biomedical Laboratories (BMBL) contains the biosafety guidelines and recommendations for work with microbial agents, as determined by the CDC and National Institutes of Health. Training ensures that proper personal protective equipment is donned and functioning properly prior to entry into any containment suite; such equipment may include gloves, Tyvek coveralls, autoclavable shoes or boots, protective eyewear, face masks, and negative-or positive-pressure respirators based on appropriate biosafety level determination. The final select agent rules added the requirement that drills or exercises of security, biosafety, and incident response plans be conducted at least annually. As the environmental parameters and other conditions within the regulatory requirements, guidelines, and recommendations change, facility review committees (e.g., institutional biosafety committees) and timely updates are necessary to reflect those changes.

Citation: Hawley R, Duley T. 2006. Biosafety and Biosecurity: Regulatory Impact, p 587-596. In Fleming D, Hunt D (ed), Biological Safety. ASM Press, Washington, DC. doi: 10.1128/9781555815899.ch33

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Tables

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TABLE 1

Chronology of additional accounts of biological warfare and terrorism

Citation: Hawley R, Duley T. 2006. Biosafety and Biosecurity: Regulatory Impact, p 587-596. In Fleming D, Hunt D (ed), Biological Safety. ASM Press, Washington, DC. doi: 10.1128/9781555815899.ch33
Generic image for table
TABLE 2

Select agents and toxins covered by the Select Agent Program

Citation: Hawley R, Duley T. 2006. Biosafety and Biosecurity: Regulatory Impact, p 587-596. In Fleming D, Hunt D (ed), Biological Safety. ASM Press, Washington, DC. doi: 10.1128/9781555815899.ch33
Generic image for table
TABLE 3

Attenuated strains of DHHS and USDA agents and toxins excluded from the Select Agent Program

Citation: Hawley R, Duley T. 2006. Biosafety and Biosecurity: Regulatory Impact, p 587-596. In Fleming D, Hunt D (ed), Biological Safety. ASM Press, Washington, DC. doi: 10.1128/9781555815899.ch33
Generic image for table
TABLE 4

Attenuated strains of overlap DHHS and USDA agents and toxins excluded from the Select Agent Program

Citation: Hawley R, Duley T. 2006. Biosafety and Biosecurity: Regulatory Impact, p 587-596. In Fleming D, Hunt D (ed), Biological Safety. ASM Press, Washington, DC. doi: 10.1128/9781555815899.ch33

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