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Sequence-Based Classiﬁcation of Select Agents: A Brighter Line Appendix F Summary of Relevant Legislation, Regulation, and Guidance Biological and Toxin Weapons Convention (BWC): Signed in 1972 and entered into force in 1975,1 the BWC functions as an international effort to control biological weapons and focuses on the prohibition of the development, production, and stockpiling of biological and toxin weapons. Of most immediate relevance is Article I, which states: “Each State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain: (1) Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes; (2) Weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.It is important to note that the BWC neither prohibits research on defenses against biological weapons, nor establishes any list of prohibited agents.” The Biological Weapons Anti-Terrorism Act of 1989 (Public Law 101-298, May 22, 1990): To implement the norms established by the BWC, the United States enacted the BWATA, which “established penalties for violating the Convention’s prohibitions, unless “(1) such biological agent, toxin, or delivery system is for a prophylactic, protective, or other peaceful purpose; and (2) such biological agent, toxin, or delivery system, is of a type and quantity reasonable for that purpose.” In keeping with the treaty, the legislation focused on the purpose for which agents or toxins 1 The BWC treaty’s formal title is the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction.
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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 2 “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).
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Sequence-Based Classiﬁcation of Select Agents: A Brighter Line knowingly possess any biological agent, toxin, or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justified by prophylactic, protective, bona fide research, or other peaceful purpose” (NRC 2009b). Public Health Security and Bioterrorism Preparedness and Response Act, known as the Bioterrorism Act of 2002 (Public Law 107–188, June 12, 2002): “This Act added requirements for regulations governing possession of select agents, including approval for laboratory personnel by the Attorney General following a background check by the Federal Bureau of Investigation (FBI). It also gave the U.S. Department of Agriculture (USDA), through its Animal and Plant Health Inspection Service (APHIS), the authority to regulate the possession, use, and transfer of BSAT that relate to plant and animal health and products, complementing the authority granted to CDC for human pathogens. The regulation of select agents and toxins is thus a shared federal responsibility involving HHS/CDC, USDA/APHIS, and the Department of Justice (DOJ). The Bioterrorism Act has been implemented through a series of regulations; the final regulations—42 CFR 73 (human pathogens), 9 CFR 121 (animal pathogens), and 7 CFR 331 (plant pathogens)—became effective in the spring of 2005.3 (NRC 2009)” Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins (7 CFR 331; 9 CFR 121) established the initial list of biological agents and toxins determined to have the potential to pose a severe threat to animal or plant health, or to animal or plant products. Applicability of the Select Agent Regulations to Issues of Synthetic Genomics: The CDC has provided guidance regarding the application of the current Select Agent Regulations to those who create and use synthetic genomic products. Specifically, the guidance defines the organisms whose genomes are covered and provides examples that clarify the application of these rules (Appendix E). Screening Framework Guidance for Synthetic Double-Stranded DNA Providers: HHS has issued guidance to Synthetic DNA Providers, which requests that providers identify and follow up on sequences with homology unique to a Select Agent sequence. Thus, the guidance aims to define the boundaries between the sequence of a a Select Agent and a similar sequence from a related species. 3 Agents that can affect both human and animals, called “overlap agents,” are listed in both the CDC and USDA lists.
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Sequence-Based Classiﬁcation of Select Agents: A Brighter Line Executive Order July 2, 2010: Optimizing the Security of Biological Select Agents and Toxins in the United States directs federal agencies to institute changes in the current implementation of the Select Agent Regulations. The Executive Order also directs federal agencies to take actions to improve the overall coordination, consolidation and oversight of select agents and toxins: (See Appendix M)