Responsible Research with Biological Select Agents and Toxins (2009) / Chapter Skim
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5 Managing BSAT Research and the Select Agent Program
5 Managing BSAT Research and the Select Agent Program
Pages 105-134
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From page 105... ...
The issues addressed here relate to stakeholder engagement in the Select Agent Program, the list of select agents and toxins, the need for accountability, security based on risk assessment, the role of evaluation in moving forward, improvement of the laboratory inspection system and inspector training, and mechanisms needed to fund security and compliance. FACILITATING STAKEHOLDER INPUT BY FORMATION OF A BSAT ADVISORY COMMITTEE One of the frequent themes that emerged from the public consultations held by the Executive Order (EO)
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From page 106... ...
, the committee believes a more formal structure is needed to engage the community of stakeholders in the operation of the program. To provide a locus for both feedback from the research community and discussion of issues of common interest, the committee recommends the establishment of a Biological Select Agents and Toxins Advisory Committee (BSATAC)
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From page 107... ...
Representatives from the federal agencies with a responsibility for funding, conducting, or oversee ing select agent research would serve in an ex officio capacity. Among the responsibilities of this advisory committee should be the following: • Promulgate guidance on the implementation of the Select Agent Program; • Facilitate exchange of information across institutions and sectors; • Promote sharing of successful practices across institutions and sectors; • Provide oversight for evaluation of the Select Agent Program; • Provide advice on composition/stratification of the list of select agents and toxins; • Convene regular meetings of key constituency groups; and • Promote harmonization of regulatory policies and practices.
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From page 108... ...
provides expert advice and recommendations to the HHS Secre tary and Assistant Secretary on issues related to human research subjects and reviews selected work and activities within HHS.2 Similar to the proposal for BSATAC, SACHRP is composed of experts from outside the government along with nonvoting ex officio members from the relevant federal agencies. STRATIFICATION OF THE LIST OF SELECT AGENTS AND TOXINS The current list of select agents and toxins contains more than 80 entries.
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From page 109... ...
Finally, a graded approach to security has been ongoing for some time in work with nuclear materials, so there is precedent for implementing different security procedures based on risk.5 The committee concluded that the present all-encompassing model for the list of select agents and toxins does not address appropriately the range of risks and vulnerabilities presented by these agents. Moreover, a list of more than 80 agents of varying risk dilutes attention from those that pose the great est degree of concern, which may, in the process, render the nation less secure.
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From page 110... ...
Stratification should be consistent with the original purpose of creating the list, namely to catalogue those agents that pose a risk for use as a significant biothreat agent. If the purpose of the Select Agent Program were to protect the public from any infectious organism representing a threat to public health, then such a select agent list would be both unwieldy and highly disruptive to biomedical research -- in fact, all infectious disease research would then be subject to inclusion on the list.
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From page 111... ...
A team composed of subject matter experts from within the federal government -- the Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC) -- currently advises the Select Agent Program on proposals to add or delete agents or toxins from the list.6 At present there is 6 The members of the ISATTAC are federal government employees from CDC, APHIS, NIH, the Food and Drug Administration, USDA/Agricultural Research Service (ARS)
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From page 112... ...
This Advisory Committee should also advise the Select Agent Program on the implications that stratifica tion of the list of select agents and toxins has on implementation of personnel screening, physical security requirements, and other procedures. It should be noted that addition of an agent or toxin to the list will have a significant impact on the conduct of research on that agent or toxin because the research will go from no special security requirements to the full comple ment of the select agent regulations.
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From page 113... ...
(CDC/APHIS 2007) Entities or individuals required to register under the Select Agent Program must develop and implement a written security plan that describes procedures for inventory control, the reporting of loss or theft of select agents and toxins, or the alteration of inventory records, among other elements.
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From page 114... ...
aEquivalent regulations for record-keeping for animal and plant select agents and toxins appear in § 331.17 of 7 CFR 331 and § 121.17 of 9 CFR 121.
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From page 115... ...
Requirements for counting the number of vials or other such measures of the quantity of biological select agents (other than when an agent is transported from one laboratory site to another) should not be employed because they are both unreliable and counter-productive, yielding a false sense of security.
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From page 116... ...
• Other, less lethal materials are heavily protected following a graded approach based on whether or not the materials are classified as weapons-grade and other physical properties that would affect ease of theft such as size, weight, quantity, and desir ability for terrorist or other nefarious purposes. • A wide variety of security measures have been developed and strengthened over several decades to ensure physical security of nuclear materials.
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From page 117... ...
• Currently there is no graded approach to the security of pathogens on the list of select agents and toxins. • A wide variety of security measures have been developed and strengthened over several decades to ensure security of stocks of pathogens.
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From page 118... ...
One of the most frequently suggested additional security measures to thwart an insider threat for BSAT laboratories is imposition of a "two-person" rule so that no one individual would have unsu pervised access to BSAT materials. This rule was discussed, and often strongly criticized, in the public consultations sponsored by the NSABB and EO Work ing Group on Strengthening the Biosecurity of the United States.
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From page 119... ...
If the individual on the outside detects a safety or 9 "No lone individual shall have access to a nuclear weapon. During any operation that may require access to nuclear weapons, there is a minimum of two authorized persons, each capable of detecting incorrect or unauthorized procedures with respect to the task to be performed and familiar with applicable safety and security requirements.
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From page 120... ...
SECURITY BASED ON RISK ASSESSMENT Physical security is required of all facilities registered with the Select Agent Program.10 Each facility must develop and implement a written security plan, which is reviewed by either CDC or APHIS as part of the initial and ongoing facility registration process. Because each facility is different in design, 10 Department of Health and Human Services, 42 CFR 72 and 73; 42 CFR 1003 provide the final rule on the Possession, Use and Transfer of Select Agents and Toxins.
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From page 121... ...
Describe procedures for physical security, inventory control, and in formation systems control; 2. Contain provisions for the control of access to select agents and toxins; 3.
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From page 122... ...
• U.S. Department of Energy, A Manual for the Prediction of Blast and Fragment Loadings on Structures • 10 CFR 20.1801 and the Nuclear Regulatory Commission regulations on security of radioactive materials • 42 CFR 73, including pathogens and toxins regulated by both HHS and USDA and non-overlap select agents of HHS • Memorandum from the Secretary of the Department of Health and Human Services dated March 6, 2002, with 12 "Requirements for Securing Select Agents," Attachment 5 • AR-XX Military Police-Biological Agent Security Program • UFC 4-010-01 DOD Anti-terrorism Standards These varied regulations and guidelines lead to inconsistencies in applica tion for a variety of reasons, reflective of the fact that facilities and regulations differ.
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From page 123... ...
This often presents subsequent inspection and compliance challenges and does not necessarily ensure greater security. RECOMMENDATION 6: The Select Agent Program should define minimum cross-agency physical security requirements, which recognize that facilities have unique risk-based security needs and associated design components, to assist facilities in meeting their regulatory obligations.
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From page 124... ...
Independent evaluation can provide useful information on how the Select Agent Program is implemented and identify important intended or unintended consequences of the program upon the research enterprise. Fortunately, there are several existing tools and techniques that could be applied in evaluating the program.
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From page 125... ...
What are the costs and benefits of these measures and processes? What impact does the Select Agent Program have on the ability of laboratories to recruit new researchers to perform research on select agents and toxins and to retain expertise within the select agent com munity?
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From page 126... ...
It is still dif ficult to know with any degree of certainty how much the different aspects of the program cost or how many researchers may or may not choose to work with select agents and toxins because of concerns about the SRA process. Going forward, more and varied types of data will be required to understand -- either in part or in full -- the impact of the Select Agent Program on the research com munity, on the type and quality of research undertaken, and ultimately on the safety and security of those working with select agents and toxins and of the surrounding community.
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From page 127... ...
Such evaluation, which may be coordinated through the BSAT Advisory Committee, should be provided with dedi cated funding. The committee believes that it would be effective for evaluation to be coordinated through the BSATAC, since it will provide an important advisory role across the entire Select Agent Program, including the connections between regulatory agencies, funding agencies, and entities performing BSAT research.
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From page 128... ...
The current statutory authority of agencies with responsibility for the Select Agent Program will likely make it difficult to achieve a perfectly streamlined system of oversight and inspection. For example, the committee recognizes that it will be difficult for one agency to defer completely to the inspection conducted by a different agency because of Congressionally mandated respon sibilities and different areas of focus.
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From page 129... ...
Although the Select Agent Program seeks to hire inspectors with scientific experience, including work in select agent laboratories, there are others hired who come from a biosafety or regulatory background but without an understanding of the select agent laboratory environment. These challenges are even more severe for those government agencies that do not focus on select agents, such as the community of state and local health officials who have rarely encountered a select agent facility but may have a responsibility for inspecting them.
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From page 130... ...
FUNDING SECURITY AND COMPLIANCE COSTS Security and compliance procedures called for under the Select Agent Program can be significant, with costs substantially higher than for similar laboratory facilities. Security guards, cameras, access card readers, biometric identification technologies, alarms, lockable freezers and incubators, and other security measures all add to the cost of operating a select agent laboratory.
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From page 131... ...
that will conduct research with select agents and other materials at the BSL-2 and BSL-3 safety levels. GMU security officials mentioned an intent to dedicate 13 security officers to provide round-the-clock protection to this single 52,000 square foot laboratory building with a staff of fewer than 70 people.
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From page 132... ...
Other facilities may be limited to internally supported research with all of the security and compliance costs dependent upon indirect cost recovery and additional institutional support. While the challenges of sustainable funding for scientific research go far beyond select agent research and this report, the implications are more troubling in the case of select agent research.
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From page 133... ...
Funds to support security and compliance should be from a separate source to avoid diminishing the already limited support for research and should be avail able on a continuing and competitive basis for the life of the facility. RECOMMENDATION 9: Because of considerable security and compli ance costs associated with research on biological select agents and tox ins, federal agencies funding BSAT research should establish a separate category of funding to ensure sustained support for facilities where such research is conducted.
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From page 134... ...
, a consortium of 61 aca demic institutions that serves as an advisory committee to the federal agencies. UNOLS works with relevant federal agencies to develop the most efficient and cost-effective schedule of science cruises for each ship.
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