Biosafety Laboratories: BSL-4 Laboratories Improved Perimeter Security Despite Limited Action by CDC
Published: 2009-07-07T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Biosafety laboratories are primarily regulated by either the Department of Health and Human Services (HHS) or the U.S. Department of Agriculture (USDA), depending on whether the substances they handle pose a threat to the health of humans or plants, animals, and related products, respectively. Currently, all operational biosafety level 4 (BSL-4) labs are overseen by HHS's Centers for Disease Control and Prevention (CDC). BSL-4 labs handle the world's most dangerous agents and toxins that cause incurable and deadly diseases. In September 2008, GAO reported that two of the five operational BSL-4 labs had less than a third of the key perimeter security controls GAO assessed and recommended that CDC implement specific perimeter controls for all BSL-4 labs. GAO was asked to (1) provide an update on what action, if any, CDC took to address the 2008 recommendation; (2) determine whether perimeter security controls at the two deficient BSL-4 labs had improved since the 2008 report; and (3) provide other observations about the BSL-4 labs it assessed. To meet these objectives, GAO reviewed CDC's statement to Congress as well as other agency and HHS documentation on actions taken or to be taken with respect to the 2008 recommendation, reviewed new security plans for the two deficient BSL-4 labs, and performed another physical security assessment of these two labs. GAO is not making any recommendations.
section_title: What GAO Found
paragraphs: Significant perimeter security differences continue to exist among the nation's five BSL-4 laboratories operational at the time of GAO's assessment. In 2008, GAO reported that three of the five labs had all or nearly all of the 15 key controls GAO evaluated. Two labs, however, demonstrated a significant lack of these controls, such as camera coverage for all exterior lab entrances and vehicle screening. As a result, GAO recommended that CDC work with USDA to require specific perimeter security controls at high-containment facilities. However, to date, CDC has taken limited action on the GAO recommendation. The two labs GAO found to be deficient made progress on their own despite CDC's limited action. One made a significant number of improvements, thus reducing the likelihood of intrusion. The second made a few changes and formed a committee to consider and prioritize other improvements. Two additional observations about BSL-4 labs concern the significant perimeter security differences among the five labs GAO originally assessed for its 2008 report. First, labs with stronger perimeter controls had additional security requirements mandated by other federal agencies. For example, one lab is a military facility subject to far stricter Department of Defense physical security requirements. Second, CDC inspection officials stated their training and experience has been focused on safety. CDC officials said they are developing a comprehensive strategy for safety and security of labs and will adjust the training and inspection process to match this strategy. In commenting on findings from this report, CDC and the two labs provided additional information on steps taken in response to GAO's prior recommendation and findings.

section_title: Letter
paragraphs: This report responds to continuing congressional interest in perimeter  security at the nation’s biosafety level 4 (BSL-4) laboratories, which  handle substances that cause incurable and deadly diseases. According to  the Commission on the Prevention of Weapons of Mass Destruction  Proliferation and Terrorism, a major hurdle for terrorists seeking  biological weapons has been the difficulty in acquiring disease-causing  microbes and toxins that can be used to harm humans, livestock, or  crops. According to the commission, dangerous pathogens can be isolated  from natural sources, but it would generally be easier for terrorists to steal  or divert well-characterized “hot” strains from a research lab or culture  collection. In December 2008, the commission wrote that it believed unless  the world community acts decisively and with great urgency, it is more  likely than not that a weapon of mass destruction will be used in a  terrorist attack somewhere in the world by the end of 2013. The  commission also stated it believed that terrorists are more likely to be able  to obtain and use a biological weapon than a nuclear weapon.
Labs that work with infectious microorganisms or hazardous biological  materials are classified into four ascending levels of containment, based  on origin, risk of infection, severity of disease, and other factors. BSL-4  labs handle the world’s most dangerous substances — those that are  exotic in origin and easily transmit life-threatening diseases for which no  treatment exists, such as the Ebola and smallpox viruses. Federal law  gives regulatory control for pathogens and toxins to either the Department  of Health and Human Services (HHS) or the U.S. Department of  Agriculture (USDA), depending on whether these substances pose a threat  to humans or to plants, animals, and products made from them,  respectively. The law requires HHS and USDA to review and publish a list  of these substances, called select agents and toxins. All labs handling  select agents must be registered with either HHS or USDA. The nation’s  operational BSL-4 labs are currently all overseen by HHS’s Centers for  Disease Control and Prevention (CDC), since they work with substances  deemed a threat to humans. Regulations for select agents require labs to  conduct a site-specific risk assessment and develop a plan to guard against  unauthorized access, theft, loss, or release, but they do not mandate  specific perimeter security controls be put in place.
This report summarizes our findings and recommendation from our  report last year on key perimeter security controls at five of the nation’s  operational BSL-4 labs. In addition, we were asked to provide an update  on what efforts, if any, CDC has taken to address our recommendation  from that report. Further, this report describes the improvements, if any,  that have been made to the perimeter security controls at the two labs  found to be deficient. Finally, this report provides other observations  about the BSL-4 labs we assessed.
This report is partly based on our previously issued report, which was  conducted in accordance with standards prescribed by the President’s  Council on Integrity and Efficiency. In obtaining an update on whether  CDC addressed our recommendation, we obtained and reviewed CDC’s  statement to congressional committees on actions taken or to be taken by  the agency. We also asked that CDC officials apprise us on any other  efforts they made to address our recommendation. To determine what  improvements the deficient BSL-4 labs made, we asked lab officials to  provide us with a list of perimeter security enhancements implemented  since our report was issued. After we received the information, we  conducted site inspections to verify the improvements and received  briefings by lab officials on other planned enhancements. We also  evaluated whether the planned and executed improvements fulfilled any of  the 15 physical security controls we assessed in our prior report. Although  BSL-4 labs may have different levels of inherent risk, we determined that  these 15 controls (discussed in more detail in app. I) represent a baseline  for strong perimeter security. We did not test whether the controls the labs  did have in place were operating effectively.
We conducted our assessment from January 2009 through March 2009 in  accordance with standards prescribed by the Council of the Inspectors  General on Integrity and Efficiency. We provided officials from CDC and  the two deficient BSL-4 labs with the pertinent sections of a draft of this  report. We received written comments from these officials and have  incorporated their comments throughout the report, as appropriate.
subsections: section_title: Security Assessment from Prior Report
paragraphs: Select agent regulations do not mandate that specific perimeter security  controls be present at 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, our September 2008 report demonstrated  that two labs had a significant lack of these controls (see table 1 below).
Lab C: Lab C had in place 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 real-time camera  monitoring, the possibility that security officers could detect an intruder  entering the perimeter and respond to such an intrusion is greatly reduced.
Lab E: Lab E was one of the weakest labs we assessed, with 4 out of the  15 key controls in place. 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 and thus did  not portray a strong, professional security infrastructure. 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 real-time monitoring of  cameras.
Although the presence of the controls we assessed does not automatically  ensure a secure perimeter, having most of these controls in place and  operating effectively reduces the likelihood of intrusion. As such, we  recommended that the Director of the CDC take action to implement  specific perimeter controls for all BSL-4 labs to provide assurance that  each lab has a strong perimeter security system in place. As part of this  recommendation, we stated that the CDC should work with USDA to  coordinate its efforts, given that both agencies have the authority to  regulate select agents. In its response to the report, HHS agreed that  perimeter security is an important deterrent against theft of select agents.  HHS indicated that the difference in perimeter security at the five labs was  the result of risk-based planning; however, they did not comment on the  specific vulnerabilities we identified and whether these should be  addressed. In regard to requiring specific perimeter controls for all BSL-4  labs, HHS stated that it would perform further study and outreach to  determine whether additional federal regulations are needed.
section_title: CDC Has Taken Limited Action to Require Specific Perimeter Security Controls
paragraphs: Significant perimeter security differences continue to exist among the  nation’s five BSL-4 labs operational at the time of our most recent  assessment. As of May 2009, CDC has taken limited steps to address our  recommendation that it should take action to implement specific  perimeter security controls for all BSL-4 labs. Since the release of our  report in September 2008, CDC stated that the following actions have been  taken:  In late 2007, CDC, along with other federal agencies, established a U.S.  Government Trans-Federal Task Force on Optimizing Biosafety and  Biocontainment Oversight. The task force was formed to assess the  current framework for local and federal oversight of high-containment  laboratory research activities and facilities, including the identification  and assessment of pertinent laws, regulations, policies, guidelines, and  examination of the current state of biosafety oversight systems. The  task force held a public consultation meeting in December 2008.  According to CDC, the task force will communicate specific  recommendations about the nation’s lab safety and security issues to  the Secretaries of both HHS and USDA.
CDC and USDA hosted a workshop series in Greenbelt, Maryland, in  December 2008 for all of its registered entities and partners. CDC  stated that it included several safety and security topics, including  discussion of physical security and operational security.
In January 2009, in response to Executive Order 13486, a federal  working group (WG) was convened to review current laws,  regulations, and guidelines in place to prevent theft, misuse, or  diversion to unlawful activity of select agents and toxins. The WG is  chaired by HHS and the Department of Defense (DOD) and includes  representatives from several federal agencies and includes a subgroup  that is focused on physical and facility security of biolabs. The WG is  expected to issue its final report to the President by July 2009.
Although CDC has taken some modest steps for studying how to improve  perimeter security controls for all BSL-4 labs, CDC has not established a  detailed plan to implement our recommendation. In addition, we requested  documentation (e.g., minutes, interim reports) from the WG to  substantiate whether progress was made in addressing our concerns.  However, the WG responded to our request stating that they do not expect  to make any interim reports, and they refused to provide us the minutes of  their meetings. Without a detailed plan from CDC on what corrective  actions are planned or information on any progress from the WG, it is  impossible to monitor CDC’s progress in implementing our  recommendation to improve perimeter security controls for all BSL-4 labs.  The ability to monitor progress openly and in a transparent manner is  especially important because a sixth BSL-4 lab recently became  operational, as mentioned above, and CDC expects more BSL-4 labs to be  operational in the future.
section_title: Two Labs Take Action to Improve Perimeter Security Controls
paragraphs: Although CDC has taken limited action to address our original findings,  the two deficient BSL-4 labs have made progress on their own. One BSL-4  lab made a significant number of improvements to increase perimeter  security, thus reducing the likelihood of intrusion. The second one made  three changes and formed a committee to consider and prioritize other  changes.
subsections: section_title: Lab C
paragraphs: We confirmed the following improvements at Lab C:    Visitors are screened by security guards and issued visitor badges.
A command and control center was established.
Camera coverage includes all exterior lab entrances.
CCTV is monitored by the command and control center. The cameras  currently cover the exterior of the building. Guards can control the  cameras by panning, zooming, or tilting.
One visible guard is present at the main entrance to the lab, but the  guard is not armed. A guard mans the entrance 24 hours a day, 7 days a  week. Although the guard is unarmed, this improvement does partially  address the requirement for guard presence at lab public entrances.  Lab officials described installing armed guards as cost prohibitive.
While the loading dock is still located inside the footprint of the main  building, Lab C improved its loading dock security by building a  loading dock vehicle gate. Moreover, a pedestrian gate with a sign  forbidding entry was built to prevent pedestrians from entering the  building through the loading dock; pedestrians were previously  allowed to enter the building through the loading dock as a way of  taking a short-cut into the building. These new gates prevent  individuals from walking into the building, or vehicles driving up to the  building, unchallenged.
Lab officials said additional enhancements would be completed by fall  2009. These include an active intrusion detection system that is integrated  with CCTV and the addition of 14 new interior cameras with pan, tilt, and  zoom capabilities. The new cameras will enhance the interior perimeter  security of the lab. The command and control center also will have access  to and control of these new cameras. After these improvements are  finished, the lab will have 8 of the 15 controls we tested in place plus 2  others that were partially addressed.
section_title: Lab E
paragraphs: We verified three improvements were made at Lab E: heavy concrete  planters were added as a vehicle barricade along the roadside adjacent to  the building; the window was frosted to block sight lines into the lab from  nearby rooftops; and a vehicle barricade is being constructed to block  unauthorized access to the parking lot adjacent to the lab, thereby  increasing the blast stand-off area. The lab also formed a committee to  consider additional perimeter security measures such as widening buffer  zones and increasing lighting at the perimeter fence. In all, the lab now has  6 of the 15 controls we assessed in place.
Although lab officials made three improvements and are considering  others, the lab’s head of research operations at the facility objected to the  findings of our 2008 report and has challenged the 15 controls we deemed  critical to strong perimeter security. He said that the officials from the lab  were not afforded an opportunity to respond to the report and correct  “inaccuracies.” Specifically, he made the following comments on our  previous findings:    He questioned the basis for our selection of the specific 15 controls we  identified as critical to perimeter security, and noted that CDC also  expressed similar concerns in its comments on our 2008 report.
The lab windows do not provide direct access to the lab. He  maintained that a number of features prohibited entry by these  windows: the lowermost edge of the windows is more than 7 feet   8 inches above ground level; the windows are certified bulletproof  glass and are equipped with inside bars; and breaching the integrity of  the outer bulletproof glass triggers alarms for the local guard force.  Furthermore, he said that having such a window was deemed  programmatically important when the laboratory was designed in  order to provide light-dark orientation for laboratory workers. Finally,  he represented that a group of nationally recognized security experts  has opined that the windows are not a security threat, but did not  provide evidence of these experts’ assessment.
Armed guards are present on the campus. He stated that a table in our  2008 report indicates that armed guards are not present on the  campus, although a footnote on a subsequent page acknowledges that  an armed security supervisor patrols the facility.
A vehicle barrier does surround the perimeter of that portion of the  laboratory building housing select agents, including the BSL-4  laboratory. He said it was recommended and approved by the Federal  Bureau of Investigation during consultations on the safety of the  building and installed in 1999 prior to initiation of research in this  facility.
We continue to believe that our assessment of perimeter controls at Lab E  is accurate. Specifically, we disagree with Lab E’s position as follows:    As stated in the report, we developed the 15 security controls based on  our expertise in performing security assessments and our research of  commonly accepted physical security principles. Although we  acknowledge that the 15 security controls we selected are not the only  measures that can be in place to provide effective perimeter security,  we determined that these controls (discussed in more detail in app. I)  represent a baseline for BSL-4 lab perimeter physical security and  contribute to a strong perimeter security system. Having a baseline  provides fair representation as to what key perimeter security controls  do or do not exist at these facilities. The controls represent commonly  accepted physical security principles. A lack of such controls  represents a potential security vulnerability. For example, as  mentioned above, at the time of our original assessment Lab E had  only limited camera coverage of the outer perimeter of the facility.  Camera coverage of a building’s exterior provides a means to detect  and quickly identify potential intruders.
As mentioned above, Lab E was the only lab with an exterior window  that could provide direct access to the lab. This window allowed for  direct “visual” access into the lab area from an adjacent rooftop. Lab E  in essence acknowledged this when it informed us in a letter that it  “Frosted the BSL-4 laboratory windows to block sight lines from  adjacent rooftops.” While we credit Lab E for obscuring visual access  to the lab by frosting this window, the window continues to pose a  security vulnerability because it is not blast proof.
Armed guards are not present on the campus. As mentioned above,  Lab E’s head of research operations pointed out that our 2008 report  acknowledged that an armed security supervisor patrols the facility.  However, employing one armed security supervisor does not support  the plural definition of “guards.” The supervisor also is not generally at  the entrances to the facility. He normally responds to incidents and  would not generally be in a position to confront an intruder at the  point of attack. Furthermore, placing armed guards at entrances also  functions as a deterrent.
The vehicle barrier did not surround the full perimeter of the BSL-4 lab  building as it adjoined another lab building at the time of our original  assessment. The facility has since placed additional barriers as noted  in this report to give full coverage, thus validating our original  assessment. Furthermore, part of the barrier in the area between a  small parking lot and the BSL-4 lab building did not provide an  adequate blast stand-off area. The lab, as noted in this report, has since  erected barriers to this parking lot to allow only deliveries into the  area.
section_title: Additional Observations on Federal Oversight of BSL-4 Labs
paragraphs: During the course of our work, we made two additional observations that  concern perimeter security differences among the nation’s five BSL-4 labs  that were operational at the time of our assessment:    All five BSL-4 labs operating in 2008 had a security plan in place when  we assessed them. Yet significant perimeter security differences exist  among these high-containment labs. A reason for the discrepancies can  be found in the additional federal security requirements the three labs  with strong perimeter security controls in place had to follow beyond  the select agent regulations. For example, Lab B is a military facility  subject to far stricter DOD physical security requirements. It had a  perimeter security fence and roving patrol guards visible inside and  outside this fence. Labs A and D also must meet additional mandates  from the federal agencies that oversee them. A lack of minimum  perimeter security requirements contributes to sharp differences  among BSL-4 labs as well.
CDC inspection officials stated their training and experience had been  mainly in the area of safety. They also noted that their philosophy is a  layered approach to security and safety. According to CDC officials,  they are developing a comprehensive strategy for safety and security  of biosafety labs and will adjust the training and inspection process  accordingly to match this comprehensive strategy.
section_title: Agency and Third- Party Comments and Our Evaluation
paragraphs: We briefed CDC on the results of our work, and received comments from  CDC by e-mail. In its response, CDC stated that it agrees that perimeter  security is an important deterrent against theft of select agents and should  be considered as one component of overall security at select laboratories.  CDC stated that a comprehensive approach to securing select agents  should be taken, and should include basic components such as physical  security, personnel security, information security, transport security, and  material control and accountability. CDC stated that its Select Agent  Regulations reflect this comprehensive approach to securing agents and  provide performance standards that entities must implement to protect  agents from theft, loss, or release.
CDC also stated that multiple groups are assessing the issue of laboratory  security and developing related recommendations. CDC stated that it will  consider our prior recommendation and the reports from the multiple  groups together before developing a detailed plan to address security at  select agent laboratories. As part of this commitment, CDC stated that it is  in the process of hiring a Security Officer to ensure that CDC has a  continuing focus on security at the laboratories. According to CDC, the  Security Officer will work with USDA to consider the recommendations  from us and others in developing the plan to enhance security at select  agent laboratories. In addition, CDC stated that it, in coordination with  USDA, will seek input as to the need and advisability of requiring by  federal regulation specific perimeter controls at each registered entity  having a BSL-4 laboratory. CDC will initiate this process once all of the  recommendations from the aforementioned groups have been received.   CDC’s stated intent to study our prior recommendation in improving  laboratory security is an important response to the security issues that  have been identified.
We also provided officials from Lab C and Lab E with the pertinent  sections of a draft of this report that covered the results of our most recent  perimeter security assessment of their labs, to which they responded with  comments. Lab C officials provided additional details about several  changes they made or plan to make to the lab’s perimeter security  controls, including changes to its CCTV, camera coverage, loading dock,  barriers, and blast stand-off area. For example, Lab C officials said they  are extending the sidewalks and installing landscaping features around the  lab building to increase the size of the blast stand-off area. According to  officials from Lab E, they plan to submit a grant application for additional  perimeter security improvements, including an intrusion detection system  at the perimeter fence and expanded CCTV coverage of key perimeter  areas. We did not verify the perimeter security enhancements from Lab C  and Lab E because these changes were made or planned subsequent to our  most recent assessment. Officials from these labs also provided technical  comments on the draft language from our report that we have  incorporated throughout the report, as appropriate.
As agreed with your office, unless you announce the contents of this  report earlier, we will not distribute it until 30 days after its issue date. At  that time, we will send copies of this report to the Secretary of Health and  Human Services, the Director of CDC, and other interested parties. In  addition, the report will be available at no charge on GAO’s Web site at  http://www.gao.gov. If you or your staff have any questions regarding this  report, please contact me at (202) 512-6722 or kutzg@gao.gov. Contact  points for our Offices of Congressional Relations and Public Affairs may  be found on the last page of this report. GAO staff who made major  contributions to this report are listed in appendix II.
section_title: Appendix I: Perimeter Security Controls
paragraphs: To perform our perimeter security assessment of biosafety level 4 (BSL-4)  labs, we identified 15 key perimeter security controls. We based their  selection on our expertise and research of commonly accepted physical  security principles that contribute to a strong perimeter security system. A  strong perimeter security system uses layers of security to deter, detect,  delay, and deny intruders:    Deter. Physical security controls that deter an intruder are intended to  reduce the intruder’s perception that an attack will be successful—an  armed guard posted in front of a lab, for example.
Detect. Controls that detect an intruder could include video cameras  and alarm systems. They could also include roving guard patrols.
Delay. Controls that delay an intruder increase the opportunity for a  successful security response. These controls include barriers such as  perimeter fences.
Deny. Controls that can deny an intruder include visitor screening that  only permits authorized individuals to access the building housing the  lab. Furthermore, a lack of windows or other obvious means of  accessing a lab is an effective denial mechanism.
Some security controls serve multiple purposes. For example, a perimeter  fence is a basic security feature that can deter, delay, and deny intruders.  However, a perimeter fence on its own will not stop a determined intruder.  This is why, in practice, layers of security must be integrated in order to  provide the strongest protection. Thus, a perimeter fence should be  combined with an intrusion detection system that would alert security  officials if the perimeter has been breached. A strong system would then  tie the intrusion detection alarm to the closed-circuit television (CCTV)  network, allowing security officers to immediately identify intruders. A  central command center is a key element for an integrated, active system.  It allows security officers to monitor alarm and camera activity—and plan  the security response—from a single location. Table 3 shows 15 physical  security controls we focused on during our assessment work.
section_title: Appendix II: GAO Contact and Staff Acknowledgments
paragraphs: Gregory D. Kutz, (202) 512-6722 or kutzg@gao.gov.
subsections: section_title: Acknowledgments
paragraphs: In addition to the contact named above, the following individuals made  contributions to this report: Andy O’Connell, Assistant Director; Matt  Valenta, Assistant Director; Christopher W. Backley; Randall Cole; John  Cooney; Craig Fischer; Vicki McClure; Anthony Paras; and Verginie  Tarpinian.