The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 created the government’s Select Agent Regulations, dividing primary responsibility for regulatory control of select biological agents between HHS and USDA. While HHS is responsible for regulating select agents that can potentially pose a severe threat to public health and safety, USDA regulates select agents that can potentially pose a severe threat to animal and plant health or animal and plant products. A number of “overlap agents” can pose both a public health threat and a threat to animals; in these cases, labs must register with either agency, but are not required to register with both. As mentioned above, all five registered BSL- 4 labs in the United States are registered with DSAT. When a lab registers with DSAT to handle a select agent, a site-specific risk assessment must be conducted. Regulations governing the assessment do not specify who must perform it, meaning that the assessment can be performed by officials for the lab itself. Further, labs registering with DSAT are required to develop and implement a written security plan based on the site-specific risk assessment. According to the regulations, the security plan must be sufficient to safeguard against unauthorized theft, loss, or release of select agents and meet all the requirements outlined in the Select Agent Regulations. DSAT authored and utilizes the Select Agents and Toxins Security Information Document to provide possible practices and procedures that entities may use to assist them in developing and implementing their written security plans. Additional requirements include a written biosafety or biocontainment plan that describes the safety and containment procedures, and an incident response plan that includes procedures for theft, loss, or release of an agent or toxin; inventory discrepancies; security breaches; natural disasters; violence; and other emergencies. Prior to being issued a certificate of registration, an entity must comply with all security requirements and all other provisions of the Select Agent Regulations. A registration in the CDC’s Select Agent Program lasts for 3 years, after which it must be renewed if the entity chooses to retain possession of the select agents. In addition to the five registered and operational BSL-4 labs, there are more labs currently under construction or in the planning stages. While expansion is taking place within the federal sector as well—there are many new federal facilities currently under construction or planned, which have one or more BSL-4 labs—there are also BSL-4 labs at universities, as part of state response, and in the private sector. These new facilities have not completed the registration process and were not fully operational as BSL-4 labs at the time of our assessment. CDC regulations do not mandate that specific perimeter security controls are present at all BSL-4 labs, resulting in a significant difference in perimeter security between the nation’s five labs. According to the regulations, each lab must implement a security plan that is sufficient to safeguard select agents against unauthorized access, theft, loss, or release. However, there are no specific perimeter security controls that must be in place at every BSL-4 lab. While three labs had all or nearly all of the key security controls we assessed, two labs demonstrated a significant lack of these controls. The results of our perimeter physical security assessment of the five registered BSL-4 labs are presented in table 1. The check marks in the table indicate the presence of specific security features at the labs we assessed, illustrating the varying levels of perimeter physical security controls present at the labs. Although the presence of the security controls we assessed does not automatically ensure a secure perimeter, having most controls provides increased assurance that a strong perimeter security system is in place and reduces the likelihood of unauthorized intrusion. As discussed in appendix I, the strongest perimeter security systems use an active, integrated approach to security that takes advantage of multiple layers. For example, an active, integrated system links perimeter intrusion alarms to a CCTV network, allowing security officers to instantly view the location of an alarm. A discussion of each security assessment follows. Lab A: The physical security controls of Lab A presented a strong visible deterrent from the outside, with 14 of the 15 key security controls in place. Lab A was located in a complex of other buildings that was separated from an urban environment by a perimeter security fence reinforced with airline cable to further strengthen the fence and deter unauthorized access. A roving patrol of armed guards was visible inside and outside the perimeter fence, while other guards manned gated entry inspection points. The gates incorporated technical support for the guards to assist them with the inspection of both private and commercial vehicles. Guards conducted ID checks at the gates and searched vehicles that did not have the appropriate access decals. Further, all trucks were required to enter a single gate containing an X-ray screening device. Past this outer perimeter, a further man-made barrier existed around the building containing the BSL-4 lab. Although Lab A had most of the security controls we focused on during our assessment, it did not have an active intrusion detection system integrated with the CCTV network covering the facility. This reduced the possibility that security officers could detect and quickly identify an intruder entering the building perimeter. Lab B: Lab B was the only one of the five BSL-4 labs that had all 15 security controls. The lab was in an urban environment, but located in a complex of other buildings enclosed within an outer fenced perimeter. Roving patrols consisting of both armed security guards and local police walked on the exterior of the perimeter fence. The fence itself was reinforced with airline cable to further strengthen it along areas that bordered roads, serving to further protect against unauthorized intrusion from these public areas. There was a single gated inspection point to enter the complex manned by armed security guards. The inspection point incorporated technical support for the guards to assist them with the inspection of both private and commercial vehicles. Once inside the gate, man-made barriers and a natural (i.e., landscaped) barrier system stood between the gate and the lab itself. More armed guards conducted roving patrols inside the complex and guarded the entrance to the lab itself. Lab B also had a strong active integrated security system. According to lab officials, the system featured an integrated emergency management response whereby appropriate fire and rescue vehicles were automatically dispatched after an alarm. Lab C: Lab C utilized only 3 of the 15 key security controls we assessed. The lab was in an urban environment and publicly accessible, with only limited perimeter barriers. During our assessment, we saw a pedestrian access the building housing the lab through the unguarded loading dock entrance. In addition to lacking any perimeter barriers to prevent unauthorized individuals from approaching the lab, Lab C also lacked an active integrated security system. By not having a command and control center or an integrated security system with live camera monitoring, the possibility that security officers could detect an intruder entering the perimeter and respond to such an intrusion is greatly reduced. Lab D: Although Lab D did not have an armed guard presence outside the lab or vehicle screening, it presented strong physical security controls in all other respects, with 13 of the key 15 controls we assessed. Lab D was located within the interior of a complex of buildings, providing a natural system of layered perimeter barriers that included bollards for vehicle traffic. When combined with the presence of roving armed guard patrols, Lab D projected strong visible deterrents. It also utilized an active integrated security system so that if an alarm was activated, personnel within the command and control center could survey the alarm area though monitors and utilize pan/tilt/zoom cameras to further assess the alarm area. This permits security personnel to better coordinate and determine the appropriate response. Lab E: Lab E was one of the weakest labs we assessed, with 4 out of the 15 key controls. It had only limited camera coverage of the outer perimeter of the facility and the only vehicular barrier consisted of an arm gate that swung across the road. Although the guard houses controlling access to the facility were manned, they appeared antiquated. The security force charged with protecting the lab was unarmed. Of all the BSL-4 labs we assessed, this was the only lab with an exterior window that could provide direct access to the lab. In lieu of a command and control center, Lab E contracts with an outside company to monitor its alarm in an off-site facility. This potentially impedes response time by emergency responders with an unnecessary layer that would not exist with a command and control center. Since the contracted company is not physically present at the facility, it is not able to ascertain the nature of alarm activation. Furthermore, there is no interfaced security system between alarms and cameras and a lack of live monitoring of cameras. DSAT approved the security plans for the two labs lacking most key security controls, and approved these labs to participate in the Select Agent Program as BSL-4 labs. Conversely, during our assessment, we noted that the three BSL-4 labs with all or nearly all of our 15 key controls were subject to additional federal security requirements outside the purview of the Select Agent Regulations. For example, the National Institutes of Health both funds research requiring high containment and provides guidance and requirements that are widely used to govern many of the activities in high-containment labs. Other examples of more stringent regulations for BSL-4 labs include those of military labs that also follow far stricter Department of Defense physical security requirements. For example, Lab B had several layers of security, including a perimeter security fence and roving patrol of armed guards, visible inside and outside the perimeter fence. Although these security controls are not necessary for BSL-4 labs registering with DSAT, Lab B utilized these security controls to comply with more stringent federal requirements imposed by the agency owning the facility and incorporated these controls into its security plan. Security officials at the two labs with fewer security controls (Labs C and E) told us that management and administration had little incentive to improve security because they already met DSAT requirements. Some security officials also suggested that budgetary restrictions limited attempts to make security improvements.