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Sequence-Based Classiﬁcation of Select Agents: A Brighter Line
were possessed, rather than the agents themselves. The law authorizes the government to apply for a warrant to seize any biological agent, toxin, or delivery system that has no apparent justification for peaceful purposes, but prosecution under the law would require the government to prove that an individual did not have peaceful intentions (Atlas 1999).(BSAT 33)” Critically, the BWATA reified the tenets of the BWC by establishing the first explicit criminal punishments for the development, manufacture, transfer, or possession of a biological agent, toxin, or delivery system for use as a weapon. The BWC and its implementation in the form of the BWATA form the groundwork of the Select Agent Regulations.
The Antiterrorism and Effective Death Penalty Act of 1996 (Public Law 104-132, April 24, 1996) provides the first instance of list-based attempts at the regulation of biological agents. “The Act required the Secretary of Health and Human Services (HHS) to issue regulations to govern the transport of biological agents with the potential to pose a severe threat to public health and safety through their use in bioterrorism. In establishing the list of materials to regulate, the Secretary was to consider: ‘(I) the effect on human health of exposure to the agent; (II) the degree of contagiousness of the agent and the methods by which the agent is transferred to humans; (III) the availability and effectiveness of immunizations to prevent and treatments for any illness resulting from infection by the agent; and (IV) any other criteria that the Secretary considers appropriate’ (Public Law 104-132, April 24, 1996, Sec. 511). The Secretary delegated the authority to regulate these “select agents” to the Centers for Disease Control and Prevention (CDC). To ensure that the transfer of these agents was carried out only by and between responsible parties, the CDC required that laboratories transferring select agents be registered and report each transfer”2 (NRC 2009b).
Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (Public Law Pub. L. 107-56) expands on the BWATA, making “it an offense for a person to
“The purpose of registration was to control domestic transfers based upon a permitting system. A registered laboratory could legally transfer select agents only to another registered laboratory; some transfers were denied because of concerns about the adequacy of the facility proposed to receive the agent. Transfers to nonregistered laboratories were prohibited. Registration, however, was principally a matter of notification: A laboratory was obligated to notify relevant authorities of a transfer to another registered facility and that the transfer itself complied with applicable safety standards. Specific information about particular pathogens that the facility possessed did not have to be reported, not even if they were the subjects of extensive research, so long as they were not transferred. This was not intended to be a strict licensing system but merely a way of overseeing transfers and shipments of lethal pathogens” (NRC 2004).