Responsible Research with Biological Select Agents and Toxins (2009) / Chapter Skim
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2 The Current Regulatory Environment
2 The Current Regulatory Environment
Pages 37-68
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From page 37... ...
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.
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From page 38... ...
Policies and Procedures for Research with Biological Agents and Toxins Measures to Address Safety: Biosafety Guidelines Over time, scientists have developed best practices for research with po tentially dangerous biological agents or toxins -- including but not limited to biological select agents and toxins (BSAT)
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From page 39... ...
Se curity considerations are tied to the agents being used; the specific type of agent or toxin drives the requirement for security. While some research and testing for the development of countermeasures for select agents can be conducted at BSL-2, work on the most dangerous agents requires BSL-3 and -4 conditions.
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From page 40... ...
0 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS TABLE 2-1 Recommended Practices, Safety Equipment, and Facilities for Biosafety Levels 1-4 Facilities Primary Barriers and (Secondary BSL Agents Practices Safety Equipment Barriers) 1 Not known to Standard None required Laboratory bench consistently cause microbiological and sink required diseases in healthy practices adults 2 Agents associated BSL-1 practices Primary barriers: Class I BSL-1 plus: with human disease plus: or II biosafety cabinets • Autoclave • Limited access (BSCs)
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From page 41... ...
THE BEGINNINGS OF THE SELECT AGENT PROGRAM The first legislation that sought to limit the threat that biological agents or toxins from legitimate U.S. research laboratories would fall into the hands of terrorists was the Antiterrorism and Effective Death Penalty Act of 1996 (Public Law 104–132, April 24, 1996)
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From page 42... ...
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.
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From page 43... ...
, the authority to regulate the possession, use, and transfer of BSAT materials 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)
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From page 44... ...
As mentioned in Chapter 1, at the time this report was written, two Federal Register notices were seeking comment on proposals TABLE 2-2 Current List of Select Agents and Toxins HHS SELECT AGENTS AND TOXINS Shigatoxin South American Haemorrhagic Fever viruses Abrin Flexal Botulinum neurotoxins Guanarito Botulinum neurotoxin producing species of Junin Clostridium Machupo Cercopithecine herpesvirus 1 (Herpes B virus) Sabia Clostridium perfringens epsilon toxin Staphylococcal enterotoxins Coccidioides posadasii/Coccidioides immitis T-2 toxin Conotoxins Tetrodotoxin Coxiella burnetii Tick-borne encephalitis complex (flavi)
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From page 45... ...
Nipah virus Peste des petits ruminants virus Rift Valley fever virus Rinderpest virus Venezuelan Equine Encephalitis virus Sheep pox virus Swine vesicular disease virus USDA SELECT AGENTS AND TOXINS Vesicular stomatitis virus (exotic) : Indiana subtypes VSV-IN2, VSV-IN3 African horse sickness virus Virulent Newcastle disease virusa African swine fever virus Akabane virus USDA PLANT PROTECTION AND Avian influenza virus (highly pathogenic)
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From page 46... ...
. We return to this issue in Chapters 3 and 5 but note it here as part of the context for the operation of the Select Agent Program.
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From page 47... ...
.16 Unlike formal security clearances, foreign nationals are thus eligible for access to BSAT.17 Additionally, under the Bioterrorism Preparedness Act, an individual could 14 According to several accounts of the creation of the USA PATRIOT Act, including those at the public consultation for the Executive Order Working Group on Strengthening the Biosecurity of the United States, the list of disqualifying factors was based on those in the Brady Handgun Vio lence Prevention Act (Public Law 103–159, November 30, 1993) , on the principle that anyone who would not be allowed to own a handgun should not be permitted access to dangerous pathogens.
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. 19 • Evidence of any of the disqualifying factors leads to a permanent denial of access to select agents and toxins, without statute of limitations or sunset provision on any of the prohibitions.
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It is noted in a DOJ study of the government's criminal history databases that the FBI handles more fingerprint checks for noncriminal justice purposes than for those related to law enforcement (DOJ 2006:3) ; for example, it processed approximately 10 million such requests in 2005.
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• Convicted Person on Supervised Release File • Convicted Sexual Offender Registry • Violent Gang and Terrorist Organizations File Interstate Identification Index (III; "Triple I") : state/local criminal history Foreign Terrorist Tracking Task Force • Terrorist Screening Center Database (TSDB)
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. As mentioned above, the Bioterrorism Preparedness Act added prohibi tions for work with BSAT materials that concern involvement in crimes of terrorism or with groups who commit acts of violence.
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23 Participation in the Program24 The Select Agent Program requires "registration of facilities including government agencies, universities, research institutions, and commercial entities 22 "Of current federal prisoners, 55 percent are serving time for drug offenses" (Washington Post 2009)
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Figure 2-1 R01589 that possess, use or transfer biological agents and toxins that pose a significant threat to public, animal or plant awn, alloreto animal or plant products." 25 redr health, v ctors Material provided to the committee by CDC and APHIS showed that, as of early September 2009, 388 entities had received authorization to work with select agents and toxins (see Figure 2-1) , of which 84 percent were registered with CDC and 16 percent with APHIS (Kielbauch et al.
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From page 54... ...
Federal Entities The federal government operates the largest category of entities that are part of the Select Agent Program. NIH and CDC within HHS, USDA, the 26 Most academic research laboratories that conduct non-select agent research are BSL-1, BSL-2, and BSL-3 facilities.
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From page 55... ...
They are included in the Select Agent Program because they might encounter select agents as part of routine diagnostic work and because they maintain reference strain collections to con firm specific select agents and toxins as part of the LRN. 27 The LRN also includes federal, military, environmental, veterinary, and food-testing laborato ries.
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From page 56... ...
Finally, an incident response plan is required to be sure the entity is prepared to deal with the consequences of an accident or deliberate act. Inspections "An important tenet of the CDC Select Agent Program is that it treats all registered entities the same -- whether that lab is a commercial lab, state or local public health lab, or a federal lab (including CDC and Department of Defense labs)
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From page 57... ...
are possible for more serious violations. • Referral to FBI: Possible violations involving criminal negligence or a suspicious activity or person are referred to the FBI for further investigation.30 The Select Agent Program also promotes laboratory safety and security by providing technical assistance and guidance to registered entities, which in 29 The checklists can be found at |
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. OTHER FEDERAL REGULATIONS RELATED TO BSAT RESEARCH The Select Agent Program's regulations apply to all federal agencies and departments.
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.33 • 32 The section does not address issues related to transportation, which the committee has decided not to include in its report. 33 The report goes on to say that: "The NSABB considers these to be reasonable characteristics for individuals with access to select agents and toxins.
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. The process for determining access to classified information rests on a series of executive orders dating back to the 1950s; the current process is based on EO 12968, issued in August 1995.34 Examples of Federal Agency Physical Security and Personnel Reliability Requirements This section is intended to provide a sampling, agency by agency, of some of the additional provisions that federal agencies have put in place to increase security for BSAT materials beyond the requirements of the Select Agent Pro gram.
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consists of a required initial investiga tion for federal employees who will need access to classified national security information at the Confidential and Secret levels. The ANACI includes the NACIC with additional law enforcement agency checks.
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The DOD person nel reliability program includes one kind of security clearance and background investigation for military personnel and contractors, the National Agency Check with Local Agency Check and Credit Check (NACLC) , to confirm information supplied by applicants, in most cases going back seven years.
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. Department of Energy Of the five DOE national laboratories that work with BSAT materials, all require elements of a PRP beyond what is required by the Select Agent Pro gram.
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Employees are required to report potentially disqualifying information. REGULATIONS AND PRACTICES OUTSIDE THE UNITED STATES Life sciences research is an increasingly global enterprise, including that involving BSAT materials (NRC 2006)
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From page 65... ...
Biological materials and equipment were included in the AG's concerns in the early 1990s. The AG maintains "common control lists" for dual use biological equipment and related technology and software, biological agents, and plant and animal pathogens to provide the basis for encouraging standard national export licensing regulations.
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In the cases of local control, there is almost always a provision in the regulations that higher authorities should have access to personnel records upon request. Only the UK, Germany, and Australia appear to conduct personnel screening comparable to the SRA or security clearances.
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From page 67... ...
. SUMMARY This chapter has provided background information on the origins and current operation of the Select Agent Program, additional requirements for personnel reliability and physical security that many federal agencies have ap plied to their own and, in some cases, their grant and contract BSAT research, and how the regulation of BSAT research is handled outside the United States.
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