High-Containment Laboratories
National Strategy for Oversight Is Needed Gao ID: GAO-09-1045T September 22, 2009This testimony discusses our report on a national strategy for high-containment laboratories that deal with dangerous--pathogens also known as biosafety level-3 (BSL-3) laboratories and biosafety level-4 (BSL-4) laboratories--in the United States, which was released yesterday. The number of high-containment laboratories that work with dangerous biological pathogens have proliferated in recent years. In 2007, we reported on several issues associated with the proliferation of high-containment laboratories in the United States, including risks posed by biosafety incidents that have occurred in the past. The Federal Bureau of Investigation's allegation in August 2008 that a scientist at the U.S. Army Medical Research Institute of Infectious Diseases was the sole perpetrator of the 2001 anthrax attacks raised additional concerns about the possibility of insider misuse of high-containment laboratory facilities, material, and technology. The public is concerned about these laboratories because the deliberate or accidental release of biological agents can have disastrous consequences by exposing workers and the public to dangerous pathogens. Highly publicized laboratory errors and controversies about where high-containment laboratories should be located have raised questions about whether the governing framework, oversight, and standards for biosafety and biosecurity measures are adequate. In this context, Congress asked us to address the following questions: 1. To what extent, and in what areas, has the number of high-containment laboratories increased in the United States? 2. Which federal agency is responsible for tracking the expansion of high-containment laboratories and determining the associated aggregate risks? 3. What lessons can be learned from highly publicized incidents at high-containment laboratories and actions taken by the regulatory agencies?
The recent expansion of high-containment laboratories in the United States began in response to the need to develop medical countermeasures and better risk evaluations after the anthrax attacks in 2001. Understandably, the expansion initially lacked a clear, governmentwide coordinated strategy. In that emergency situation, the expansion was based on individual agency perceptions of requirements relative to the capacity their high-containment labs required as well as the availability of congressionally appropriated funding. While there is a consensus among federal agency officials and experts that some degree of risk is always associated with high-containment laboratories, no one agency is responsible for determining, or able to determine, the aggregate or cumulative risks associated with the expansion of these high-containment laboratories. As a consequence, no federal agency can determine whether high-containment laboratory capacity may now meet or exceed the national need or is at a level that can be operated safely. Four highly publicized incidents in high-containment laboratories, as well as evidence in the scientific literature, demonstrate that while laboratory accidents are rare, they do occur, primarily due to human error or systems (management and technical operations) failure, including the failure of safety equipment and procedures. If an agency were tasked or a mechanism were established with the purpose of overseeing the expansion of high-containment laboratories, it could develop a strategic plan to (1) ensure that the number and capabilities of potentially dangerous high-containment laboratories are no greater or less than necessary, (2) balance the risks and benefits of expanding such laboratories, and (3) determine the type of oversight needed.
GAO-09-1045T, High-Containment Laboratories: National Strategy for Oversight Is Needed
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Testimony:
Before the Subcommittee on Terrorism and Homeland Security, Committee
on the Judiciary, United States Senate:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 2:30 p.m. EDT:
Tuesday, September 22, 2009:
High-Containment Laboratories:
National Strategy for Oversight Is Needed:
Statement of Nancy Kingsbury, Ph.D. Managing Director:
Applied Research and Methods:
GAO-09-1045T:
[End of section]
Mr. Chairman and Members of the Subcommittee:
[End of section]
We are pleased to be here to discuss our report on a national strategy
for high-containment laboratories that deal with dangerous--pathogens
also known as biosafety level-3 (BSL-3) laboratories and biosafety
level-4 (BSL-4) laboratories--in the United States, which was released
yesterday.[Footnote 1] The number of high-containment laboratories that
work with dangerous biological pathogens have proliferated in recent
years. In 2007, we reported on several issues associated with the
proliferation of high-containment laboratories in the United States,
including risks posed by biosafety incidents that have occurred in the
past.[Footnote 2] The Federal Bureau of Investigation's allegation in
August 2008 that a scientist at the U.S. Army Medical Research
Institute of Infectious Diseases was the sole perpetrator of the 2001
anthrax attacks raised additional concerns about the possibility of
insider misuse of high-containment laboratory facilities, material, and
technology. The public is concerned about these laboratories because
the deliberate or accidental release of biological agents can have
disastrous consequences by exposing workers and the public to dangerous
pathogens. Highly publicized laboratory errors and controversies about
where high-containment laboratories should be located have raised
questions about whether the governing framework, oversight, and
standards for biosafety and biosecurity measures are adequate.[Footnote
3] In this context, you asked us to address the following questions:
[Footnote 4]
1. To what extent, and in what areas, has the number of high-
containment laboratories increased in the United States?
2. Which federal agency is responsible for tracking the expansion of
high-containment laboratories and determining the associated aggregate
risks?
3. What lessons can be learned from highly publicized incidents at high-
containment laboratories and actions taken by the regulatory agencies?
To answer these questions, we interviewed federal agency officials as
well as experts in microbiology, reviewed literature, conducted site
visits, and surveyed 12 federal agencies to determine if they have a
mission to track high-containment laboratories in the United States. We
also interviewed officials from relevant intelligence agencies to
determine if they have a mission to determine insider risks in high-
containment laboratories. The expert panel that reviewed this report
was comprised of scientists with substantive expertise in
microbiological and select agent research and the operation of high-
containment laboratories.
We conducted our work from September 2005 through June 2009 in
accordance with generally accepted government auditing standards. Those
standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.
The Number of High-Containment Laboratories Is Increasing in Different
Sectors throughout the United States:
We found that since 2001, the number of BSL-4 and BSL-3 laboratories in
the United States has increased, and this expansion has taken place
across federal, state, academic, and private sectors and throughout the
United States. Federal officials and experts believe that while the
number of BSL-4 laboratories in the United States is known, the number
of BSL-3 laboratories is unknown. Information about the number,
locations, activities, and ownership is available for high-containment
laboratories that are registered with the Centers for Disease Control
and Prevention's (CDC) Division of Select Agents and Toxins (DSAT) or
the United States Department of Agriculture's (USDA) Animal and Plant
Health and Inspection Service (APHIS) select agent programs, but not
for those outside the program. The recent expansion of high-containment
laboratories in the United States began in response to the need to
develop medical countermeasures and better risk evaluations after the
anthrax attacks in 2001. Understandably, the expansion initially lacked
a clear, governmentwide coordinated strategy. In that emergency
situation, the expansion was based on individual agency perceptions of
requirements relative to the capacity their high-containment labs
required as well as the availability of congressionally appropriated
funding. Decisions to fund the construction of high-containment labs
were made by multiple federal agencies in multiple budget cycles.
Federal and state agencies, academia, and the private sector considered
their individual requirements, but an assessment of national needs was
lacking. Even now, after more than 7 years, GAO was unable to find any
projections based on a governmentwide strategic evaluation of future
capacity requirements set in light of existing capacity; the numbers,
location, and mission of the laboratories needed to effectively counter
biothreats; and national public health goals. Such information is
needed to ensure that the United States will have facilities in the
right place with the right specifications.
No Federal Agency Has the Mission to Track the Expansion of All High-
Containment Laboratories and Regulate Biosafety in the United States:
Currently, no executive or legislative mandate directs any federal
agency to track the expansion of all high-containment laboratories.
Because no federal agency has the mission to track the expansion of BSL-
3 and BSL-4 laboratories in the United States, no federal agency knows
how many such laboratories exist in the United States. While there is a
consensus among federal agency officials and experts that some degree
of risk is always associated with high-containment laboratories, no one
agency is responsible for determining, or able to determine, the
aggregate or cumulative risks associated with the expansion of these
high-containment laboratories. As a consequence, no federal agency can
determine whether high-containment laboratory capacity may now meet or
exceed the national need or is at a level that can be operated safely.
Lessons Learned from Four Incidents Highlight the Risks Inherent in the
Expansion of High-Containment Laboratories:
Four highly publicized incidents in high-containment laboratories, as
well as evidence in the scientific literature, demonstrate that while
laboratory accidents are rare, they do occur, primarily due to human
error or systems (management and technical operations) failure,
including the failure of safety equipment and procedures. One of the
incidents we reviewed involved the allegation that Dr. Bruce Ivins of
United States Army Medical Research Institute for Infectious Diseases
was the source of the 2001 anthrax attack. This incident highlights two
lessons: (1) An ill-intentioned insider can pose a risk not only by
passing on confidential information but also by removing dangerous
material from a high-containment laboratory, and (2) it is impossible
to have completely effective inventory control of biological material
with currently available technologies. It is impossible to know the
exact number of bacteria or virus in a laboratory's inventory or
working stocks at any specific time. At Fort Detrick, ineffective
procedures for the control of inventories and the unlimited use of
laboratory facilities allegedly allowed Dr. Ivins the opportunity to
pursue his own ends. As the number of high-containment laboratories
increases, there will be an increase in the pool of scientists with
expertise and, thus, the corresponding risk from insiders may also
increase. It has been suggested that personnel reliability programs
would mitigate the insider risk. The National Science Advisory Board
for Biosecurity reported that there is little evidence that personnel
reliability measures are effective or have predictive value in
identifying individuals who may pose an insider risk. Finally,
continuity of electrical power is vital for the safe functioning of
high-containment laboratories, in particular since maintenance of
essential pressure differentials using electrically driven fans
provides an important barrier for preventing the uncontrolled release
of agents. Lapses in electrical power that occurred at a CDC laboratory
raise concerns about standards in high-containment laboratory facility
design, management of construction, and operations.
Taken as a whole, these incidents demonstrate failures of systems and
procedures meant to maintain biosafety in high-containment
laboratories. For example, they revealed the failure to comply with
regulatory requirements, safety measures that were not commensurate
with the level of risk to public health posed by laboratory workers and
pathogens in the laboratories, and the failure to fund ongoing facility
maintenance and monitor the operational effectiveness of laboratory
physical infrastructure.
Conclusions:
Oversight plays a critical role in improving biosafety and ensuring
that high-containment laboratories comply with regulations. However,
some aspects of the current oversight programs provided by the HHS and
Agriculture are dependent upon entities monitoring themselves and
reporting incidents to federal regulators. Since 2001, personnel
reliability programs have been established to counter insider risks,
but their cost, effectiveness, and programmatic impact have not been
evaluated.
In conclusion, proliferation of high-containment laboratories is taking
place in all sectors. Furthermore, since no single agency is in charge
of the current expansion, no one is determining the associated
aggregate risks posed by the expansion. As a consequence, no federal
agency can determine whether high-containment laboratory capacity may
now be less than, meet, or exceed the national need or is at a level
that can be operated safely.
If an agency were tasked or a mechanism were established with the
purpose of overseeing the expansion of high-containment laboratories,
it could develop a strategic plan to (1) ensure that the number and
capabilities of potentially dangerous high-containment laboratories are
no greater or less than necessary, (2) balance the risks and benefits
of expanding such laboratories, and (3) determine the type of oversight
needed.
Such an agency or mechanism could analyze the biothreat problems that
need to be addressed by additional BSL-3 and -4 laboratories, the
scientific and technical capabilities and containment features that
such laboratories need to have, how the laboratories should be
distributed geographically, and how the activities of the laboratories
would be coordinated to achieve intended goals. The agency or mechanism
responsible for overseeing the expansion of high-containment
laboratories could also be responsible for coordinating with the
scientific community to develop guidelines for high-containment
laboratory design, construction, and commissioning and training
standards for laboratory workers; providing definitions for exposure;
developing appropriate inventory control measures; and providing
guidance on the most efficient approach to personnel reliability
programs.
Overall, the safety record of high-containment laboratories has been
good, although a number of weaknesses have become apparent over time.
Consequently, along with expansion there needs to be a commensurate
development of both operational and oversight procedures to address
known deficiencies and, as far as practicable, proactively evaluate
future risks.
Laboratory operators, in collaboration with regulators, need to develop
and work through potential failure scenarios and use that information
to develop and put in place mechanisms to challenge procedures,
systems, and equipment to ensure continuing effectiveness.
Recommendations for Executive Action:
To address these issues, we recommended that the National Security
Advisor, in consultation with the Secretaries of Health and Human
Services (HHS), Agriculture (USDA), Defense (DOD), and Homeland
Security (DHS); the National Intelligence Council; and other executive
departments as deemed appropriate identify a single entity charged with
periodic governmentwide strategic evaluation of high-containment
laboratories that will (1) determine:
* the number, location, and mission of the laboratories needed to
effectively meet national goals to counter biothreats,
* the existing capacity within the United States,
* the aggregate risks associated with the laboratories' expansion, and:
* the type of oversight needed;
and (2) develop, in consultation with the scientific community,
national standards for the design, construction, commissioning, and
operation of high-containment laboratories, specifically including
provisions for long-term maintenance.
We recommended that the Secretaries of HHS and USDA develop (1) a clear
definition of exposure to select agents and (2) a mechanism for sharing
lessons learned from reported laboratory accidents so that best
practices--for other operators of high-containment laboratories--can be
identified.
Should the Secretaries consider implementing a personnel reliability
program for high-containment laboratories to deal with insider risk, we
recommended that they evaluate and document the cost, effectiveness,
and programmatic impact of such a program.
Recognizing that biological agent inventories cannot be completely
controlled at present, we also recommended that the Secretaries of HHS
and USDA review existing inventory control systems and invest in and
develop appropriate technologies to minimize the potential for insider
misuse of biological agents.
Agency Comments and Our Evaluation:
We obtained written comments on a draft of our report from the
Secretaries of HHS and USDA. The Executive Office of the President:
National Security Council did not provide comments. HHS and USDA
concurred with our recommendations that were directed to them.
Mr. Chairman, this concludes my prepared remarks. I would be happy to
respond to any questions that you or other members of the subcommittee
may have at this time.
Contact and Acknowledgments:
If you or your staffs have any questions about this report, please
contact me at (202) 512-2700 or kingsburyn@gao.gov or Sushil K. Sharma,
Ph.D., Dr.PH, at (202) 512-3460 or sharmas@gao.gov. Contact points for
our Offices of Congressional Relations and Public Affairs may be found
on the last page of this statement. Amy Bowser, George Depaoli, Terrell
Dorn, Jeff McDermott, Jean McSween, Jack Melling, Ph.D., Corey
Scherrer, Linda Sellevaag, and Elaine Vaurio made key contributions to
this testimony.
[End of section]
Footnotes:
[1] GAO, High-Containment Laboratories: National Strategy for Oversight
Is Needed. [hyperlink, http://www.gao.gov/products/GAO-09-574]
(Washington, D.C.: Sept. 21, 2009).
[2] GAO, High-Containment Biosafety Laboratories: Preliminary
Observations on the Oversight of the Proliferation of BSL-3 and BSL-4
Laboratories in the United States, [hyperlink,
http://www.gao.gov/products/GAO-08-108T] (Washington, D.C.: Oct. 4,
2007).
[3] G.K. Gronvall et. al., "Letter to Senator Edward Kennedy and
Senator Richard Burr," Center for Biosecurity, University of Pittsburgh
Medical Center, March 3, 2009.
[4] The request letter contained several questions. In agreement with
our requester, we revised the questions as stated.
[End of section]
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