Biosafety Laboratories
BSL-4 Laboratories Improved Perimeter Security Despite Limited Action by CDC Gao ID: GAO-09-851 July 7, 2009Biosafety 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.
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.
GAO-09-851, Biosafety Laboratories: BSL-4 Laboratories Improved Perimeter Security Despite Limited Action by CDC
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
July 2009:
Biosafety Laboratories:
BSL-4 Laboratories Improved Perimeter Security Despite Limited Action
by CDC:
GAO-09-851:
GAO Highlights:
Highlights of GAO-09-851, a report to congressional requesters.
Why GAO Did This Study:
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.
What GAO Found:
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. The following table shows progress on 9 of the 15
controls GAO initially assessed.
Table: Progress on Perimeter Security Controls at Two BSL-4 Labs as of
March 2009:
Security control: Visitor screening;
Lab C: [Check];
Lab E: Previously in place.
Security control: Command and control center;
Lab C: [Check];
Lab E: Not in place.
Security control: Camera coverage for all exterior entrances;
Lab C: [Check];
Lab E: Not in place.
Security control: Closed-circuit television (CCTV) monitored by command
and control center;
Lab C: In progress;
Lab E: Not in place.
Security control: Active intrusion detection system integrated with
CCTV;
Lab C: In progress;
Lab E: Not in place.
Security control: Visible armed guard presence at all public entrances;
Lab C: Partially addressed;
Lab E: Not in place.
Security control: Loading docks located outside the footprint of the
main building;
Lab C: Partially addressed;
Lab E: Previously in place.
Security control: Barriers to prevent vehicles from approaching lab;
Lab C: Not in place;
Lab E: [Check].
Security control: Blast stand-off area (e.g. buffer zone) between lab
and perimeter barriers;
Lab C: Not in place;
Lab E: [Check].
Note: [Check] signifies control in place after GAO‘s 2008 report was
issued.
Source: GAO.
[End of table]
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.
View [hyperlink, http://www.gao.gov/products/GAO-09-851] or key
components. For more information, contact Gregory D. Kutz at (202) 512-
6722 or kutzg@gao.gov.
[End of section]
Contents:
Letter:
Security Assessment from Prior Report:
CDC Has Taken Limited Action to Require Specific Perimeter Security
Controls:
Two Labs Take Action to Improve Perimeter Security Controls:
Additional Observations on Federal Oversight of BSL-4 Labs:
Agency and Third-Party Comments and Our Evaluation:
Appendix I: Perimeter Security Controls:
Appendix II: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Results of Perimeter Physical Security Assessment:
Table 2: Progress on Perimeter Security Controls at Labs C and E as of
March 2009:
Table 3: Perimeter Physical Security Controls:
Abbreviations:
BSL-4: Biosafety level 4:
CCTV: Closed-Circuit Television:
CDC: Centers for Disease Control and Prevention:
DOD: Department of Defense:
HHS: Department of Health and Human Services:
IDS: Intrusion Detection System:
USDA: U.S. Department of Agriculture:
WG: Working Group:
WMD: Weapon of Mass Destruction:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
July 7, 2009:
The Honorable Susan M. Collins:
Ranking Member:
Committee on Homeland Security and Governmental Affairs:
United States Senate:
The Honorable Tom Coburn, M.D.
Ranking Member:
Permanent Subcommittee on Investigations:
Committee on Homeland Security and Governmental Affairs:
United States Senate:
This report responds to continuing congressional interest in perimeter
security at the nation's biosafety[Footnote 1] 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.[Footnote 2] 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.[Footnote 3] 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.[Footnote 4] 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[Footnote 5] require labs to
conduct a site-specific risk assessment and develop a plan to guard
against unauthorized access, theft, loss, or release,[Footnote 6] but
they do not mandate specific perimeter security controls be put in
place.
This report summarizes our findings and recommendation from our report
[Footnote 7] last year on key perimeter security controls at five of
the nation's operational[Footnote 8] BSL-4 labs.[Footnote 9] 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.
Security Assessment from Prior Report:
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).
Table 1: Results of Perimeter Physical Security Assessment:
No. 1;
Security controls: Outer/tiered perimeter boundary;
Lab A: [Check];
Lab B: [Check];
Lab C: [Empty];
Lab D: [Check];
Lab E: [Check].
No. 2;
Security controls: Blast stand-off area (e.g., buffer zone) between lab
and perimeter barriers;
Lab A: [Check];
Lab B: [Check];
Lab C: [Empty];
Lab D: [Check];
Lab E: [Empty].
No. 3;
Security controls: Barriers to prevent vehicles from approaching lab;
Lab A: [Check];
Lab B: [Check];
Lab C: [Empty];
Lab D: [Check];
Lab E: [Empty].
No. 4;
Security controls: Loading docks located outside the footprint of the
main building;
Lab A: [Check];
Lab B: [Check];
Lab C: [Empty];
Lab D: [Check];
Lab E: [Check].
No. 5;
Security controls: Exterior windows do not provide direct access to the
lab;
Lab A: [Check];
Lab B: [Check];
Lab C: [Check];
Lab D: [Check];
Lab E: [Empty].
No. 6;
Security controls: Command and control center;
Lab A: [Check];
Lab B: [Check];
Lab C: [Empty];
Lab D: [Check];
Lab E: [Empty].
No. 7;
Security controls: Closed-circuit television (CCTV) monitored by the
command and control center;
Lab A: [Check];
Lab B: [Check];
Lab C: [Empty];
Lab D: [Check];
Lab E: [Empty].
No. 8;
Security controls: Active intrusion detection system integrated with
CCTV;
Lab A: [Empty];
Lab B: [Check];
Lab C: [Empty];
Lab D: [Check];
Lab E: [Empty].
No. 9;
Security controls: Camera coverage for all exterior lab building
entrances;
Lab A: [Check];
Lab B: [Check];
Lab C: [Empty];
Lab D: [Check];
Lab E: [Empty].
No. 10;
Security controls: Perimeter lighting of the complex[A];
Lab A: [Check];
Lab B: [Check];
Lab C: [Check];
Lab D: [Check];
Lab E: [Check].
No. 11;
Security controls: Visible armed guard presence at all public entrances
to lab;
Lab A: [Check];
Lab B: [Check];
Lab C: [Empty];
Lab D: [Empty];
Lab E: [Empty].
No. 12;
Security controls: Roving armed guard patrols of perimeter;
Lab A: [Check];
Lab B: [Check];
Lab C: [Check];
Lab D: [Check];
Lab E: [Empty].
No. 13;
Security controls: X-ray magnetometer machines in operation at building
entrances;
Lab A: [Check];
Lab B: [Check];
Lab C: [Empty];
Lab D: [Check];
Lab E: [Empty].
No. 14;
Security controls: Vehicle screening;
Lab A: [Check];
Lab B: [Check];
Lab C: [Empty];
Lab D: [Empty];
Lab E: [Empty].
No. 15;
Security controls: Visitor screening;
Lab A: [Check];
Lab B: [Check];
Lab C: [Empty];
Lab D: [Check];
Lab E: [Check].
Source: GAO.
[A] We did not perform our assessment at night, so for this category we
relied on the lab security officials to provide this information.
[End of table]
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.[Footnote 10] 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.
CDC Has Taken Limited Action to Require Specific Perimeter Security
Controls:
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.
Two Labs Take Action to Improve Perimeter Security Controls:
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.
Lab C:
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.
Lab E:
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.
The following table summarizes the progress the two labs have made on 9
of the 15 controls we initially assessed:
Table 2: Progress on Perimeter Security Controls at Labs C and E as of
March 2009:
Security control: Visitor screening;
Lab C: [Check];
Lab E: Previously in place.
Security control: Command and control center;
Lab C: [Check];
Lab E: Not in place.
Security control: Camera coverage for all exterior entrances;
Lab C: [Check];
Lab E: Not in place.
Security control: CCTV monitored by command and control center;
Lab C: In progress;
Lab E: Not in place.
Security control: Active intrusion detection system integrated with
CCTV;
Lab C: In progress;
Lab E: Not in place.
Security control: Visible armed guard presence at all public entrances;
Lab C: Partially addressed;
Lab E: Not in place.
Security control: Loading docks located outside the footprint of the
main building;
Lab C: Partially addressed;
Lab E: Previously in place.
Security control: Barriers to prevent vehicles from approaching lab;
Lab C: Not in place;
Lab E: [Check].
Security control: Blast stand-off area (e.g., buffer zone) between lab
and perimeter barriers;
Lab C: Not in place;
Lab E: [Check].
Source: GAO.
Note: [Check] signifies control in place after our 2008 report was
issued.
[End of table]
Additional Observations on Federal Oversight of BSL-4 Labs:
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.
Agency and Third-Party Comments and Our Evaluation:
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 [hyperlink, 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.
Signed by:
Gregory D. Kutz:
Managing Director:
Forensic Audits and Special Investigations:
[End of section]
Appendix I: Perimeter Security Controls:
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.
Table 3: Perimeter Physical Security Controls:
No. 1;
Perimeter physical security control: Outer/tiered perimeter boundary;
Rationale: There should be a perimeter boundary outside the lab to
prevent unauthorized access. Examples include a reinforced perimeter
security fence or natural barrier system that uses landscaping
techniques to impede access to buildings. Outer/tiered perimeter also
includes other structures that screen visibility of the lab.
No. 2;
Perimeter physical security control: Blast stand-off area (e.g., buffer
zone) between lab and perimeter barriers;
Rationale: To minimize effects of explosive damage if a bomb were to be
detonated outside the lab, the perimeter line should be located as far
as practical from the building exterior.
No. 3;
Perimeter physical security control: Barriers to prevent vehicles from
approaching lab;
Rationale: A physical barrier consisting of natural or man-made
controls, such as bollards, designed to keep vehicles from ramming or
setting off explosives that could cause damage to the building housing
the BSL-4 lab.
No. 4;
Perimeter physical security control: Loading docks located outside the
footprint of the main building;
Rationale: Because they are areas where delivery vehicles can park,
loading docks are vulnerable areas and should be kept outside the
footprint of the main building.
No. 5;
Perimeter physical security control: Exterior windows do not provide
direct access to the lab;
Rationale: Windows are typically the most vulnerable portion of any
building; therefore, there should be no exterior windows that provide
direct access to the lab.
No. 6;
Perimeter physical security control: Command and control center;
Rationale: A command and control center is crucial to the
administration and maintenance of an active, integrated physical
security system. The control center monitors the employees, general
public, and environment of the lab building and other parts of the
complex and serves as the single, central contact area in the event of
an emergency.
No. 7;
Perimeter physical security control: CCTV monitored by the command and
control center;
Rationale: A video system that gives a signal from a camera to video
monitoring stations at a designated location. The cameras give the
control center the capability of monitoring activity within and outside
the complex.
No. 8;
Perimeter physical security control: Active intrusion detection system
(IDS) integrated with CCTV;
Rationale: An IDS is used to detect an intruder crossing the boundary
of a protected area, including through the building's vulnerable
perimeter barriers. Integration with CCTV is integral to the IDS's
ability to alert security staff to potential incidents that require
monitoring.
No. 9;
Perimeter physical security control: Camera coverage for all exterior
lab building entrances;
Rationale: Cameras that cover the exterior building entrances provide a
means to detect and quickly identify potential intruders.
No. 10;
Perimeter physical security control: Perimeter lighting of the complex;
Rationale: Security lighting of the site, similar to boundary lighting,
provides both a real and psychological deterrent, and allows security
personnel to maintain visual-assessment capability during darkness. It
is cost-effective in that it might reduce the need for security forces.
No. 11;
Perimeter physical security control: Visible armed guard presence at
all public entrances to lab;
Rationale: All public entrances require security monitoring. This
presence helps to prevent or impede attempts of unauthorized access to
the complex.
No. 12;
Perimeter physical security control: Roving armed guard patrols of
perimeter;
Rationale: The presence of roving armed guard patrols helps to prevent
or impede attempts of unauthorized access and includes inspecting vital
entrance areas and external barriers.
No. 13;
Perimeter physical security control: X-ray magnetometer machines in
operation at building entrances;
Rationale: These machines provide a means of screening persons, items,
and materials that may possess or contain weapons, contraband, or
hazardous substances prior to authorizing entry or delivery into a
facility.
No. 14;
Perimeter physical security control: Vehicle screening;
Rationale: Screening vehicles that enter the perimeter of the lab
includes an identification check and vehicle inspection, in order to
deny unauthorized individuals access and potentially detect a threat.
No. 15;
Perimeter physical security control: Visitor screening;
Rationale: Screening visitors to the lab reduces the possibility that
unauthorized individuals will gain access. Visitor screening includes
identifying, screening, or recording visitors through methods such as
camera coverage or visitor logs so that their entry to the lab is
recorded.
Source: GAO.
[End of table]
[End of section]
Appendix II: GAO Contact and Staff Acknowledgments:
GAO Contact:
Gregory D. Kutz, (202) 512-6722 or kutzg@gao.gov.
Acknowledgments:
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.
[End of section]
Footnotes:
[1] Biosafety is the discipline addressing the safe handling and
containment of infectious microorganisms and hazardous biological
materials. The principles of biosafety are containment and risk
assessment. Containment includes the practices, equipment, and facility
safeguards that protect personnel, the environment, and the public from
exposure to substances handled and stored in the lab. Risk assessment
is the process that enables the appropriate selection of practices,
equipment, and facility safeguards that can prevent lab-associated
infections.
[2] Commission on the Prevention of Weapons of Mass Destruction
Proliferation and Terrorism, World at Risk: The Report of the
Commission on the Prevention of WMD Proliferation and Terrorism
(Washington, D.C.: Dec. 2008). The creation of the commission, which
was established by Pub. L. 110-53, § 1851, 121 Stat. 266, 501 (Aug. 3,
2007), implements a key recommendation of the independent, bipartisan
9/11 Commission to address the grave threat that the proliferation of
weapons of mass destruction poses to our country.
[3] HHS, Biosafety in Microbiological and Biomedical Laboratories, 5th
ed. (Washington, D.C.: 2007).
[4] Pursuant to the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, Pub. L 107-188, § 201, 116 Stat.
594, 637 (codified at 42 U.S.C. § 262a) (Jun. 12, 2002), HHS is
required to establish and maintain a list of biological agents and
toxins that have the potential to pose a severe threat to public health
and safety. Title II, Subtitle B of the Public Health Security and
Bioterrorism Preparedness and Response Act is known as the Agricultural
Bioterrorism Protection Act of 2002. Section 212, 116 Stat. 594, 647
(codified at 7 U.S.C. § 8401) of this Act requires USDA to establish
and maintain a list of biological agents that have the potential to
pose a severe threat to animal health and safety, plant health and
safety, or to the safety of animal or plant products (select agents).
The departments share responsibility for some agents because they
potentially threaten both humans and animals (overlap select agents).
[5] 42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121.
[6] Additional requirements include a written biosafety plan that
describes 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.
[7] GAO, Biosafety Laboratories: Perimeter Security Assessment of the
Nation's Five BSL-4 Laboratories, [hyperlink,
http://www.gao.gov/products/GAO-08-1092] (Washington, D.C.: Sept. 17,
2008).
[8] CDC informed us in June 2009 that a sixth BSL-4 lab has become
operational. However, we are excluding it from the scope of this report
due to its recency in becoming operational.
[9] For the purposes of this report, we defined physical security as
the combination of equipment, personnel, and operational procedures
used to protect facilities, information, documents, or material against
theft, sabotage, diversion, or other criminal acts. Our definition of
physical security excludes, and we did not evaluate, intelligence
gathering, cyber security, and human capital training and
effectiveness. We did not assess the overall security of the labs or
the threat of an insider attack, but focused on perimeter security
leading up to each building's points of entry. Additionally, we did not
test perimeter security controls to determine whether they function as
intended. Perimeter security is just one aspect of overall security
provisions under the Select Agent Regulations, which includes personnel
training and inventory control. Select Agent Regulations also require
additional security measures inside the labs themselves, such as locks
and other forms of physical control.
[10] Although the security force was unarmed, there was one armed
security supervisor patrolling the facility.
[End of section]
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