This is the accessible text file for GAO report number GAO-09-1036T 
entitled 'High-Containment Laboratories: National Strategy for 
Oversight Is Needed' which was released on September 22, 2009. 

This text file was formatted by the U.S. Government Accountability 
Office (GAO) to be accessible to users with visual impairments, as part 
of a longer term project to improve GAO products' accessibility. Every 
attempt has been made to maintain the structural and data integrity of 
the original printed product. Accessibility features, such as text 
descriptions of tables, consecutively numbered footnotes placed at the 
end of the file, and the text of agency comment letters, are provided 
but may not exactly duplicate the presentation or format of the printed 
version. The portable document format (PDF) file is an exact electronic 
replica of the printed version. We welcome your feedback. Please E-mail 
your comments regarding the contents or accessibility features of this 
document to Webmaster@gao.gov. 

This is a work of the U.S. government and is not subject to copyright 
protection in the United States. It may be reproduced and distributed 
in its entirety without further permission from GAO. Because this work 
may contain copyrighted images or other material, permission from the 
copyright holder may be necessary if you wish to reproduce this 
material separately. 

Testimony: 

Before the Subcommittee on Oversight and Investigations, Committee on 
Energy and Commerce, House of Representatives: 

United States Government Accountability Office: 
GAO: 

For Release on Delivery: 
Expected at 11:00 a.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-09-1036T: 

Mr. Chairman and Members of the Subcommittee: 

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 
working 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 
comprised 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, 
location, 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, 
locations, and missions 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 (1) 
while laboratory accidents are rare, they do occur, primarily because 
of human error or systems (management and technical operations) 
failure, including the failure of safety equipment and procedures; (2) 
insiders can pose a risk; and (3) it is difficult to control 
inventories of biological agents with currently available technologies. 
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. (4) 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.65 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 
Departments of Health and Human Services 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 was tasked or a mechanism was 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, 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, locations, 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 Evaluations: 

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] 

GAO's Mission: 

The Government Accountability Office, the audit, evaluation and 
investigative arm of Congress, exists to support Congress in meeting 
its constitutional responsibilities and to help improve the performance 
and accountability of the federal government for the American people. 
GAO examines the use of public funds; evaluates federal programs and 
policies; and provides analyses, recommendations, and other assistance 
to help Congress make informed oversight, policy, and funding 
decisions. GAO's commitment to good government is reflected in its core 
values of accountability, integrity, and reliability. 

Obtaining Copies of GAO Reports and Testimony: 

The fastest and easiest way to obtain copies of GAO documents at no 
cost is through GAO's Web site [hyperlink, http://www.gao.gov]. Each 
weekday, GAO posts newly released reports, testimony, and 
correspondence on its Web site. To have GAO e-mail you a list of newly 
posted products every afternoon, go to [hyperlink, http://www.gao.gov] 
and select "E-mail Updates." 

Order by Phone: 

The price of each GAO publication reflects GAO’s actual cost of
production and distribution and depends on the number of pages in the
publication and whether the publication is printed in color or black and
white. Pricing and ordering information is posted on GAO’s Web site, 
[hyperlink, http://www.gao.gov/ordering.htm]. 

Place orders by calling (202) 512-6000, toll free (866) 801-7077, or
TDD (202) 512-2537. 

Orders may be paid for using American Express, Discover Card,
MasterCard, Visa, check, or money order. Call for additional 
information. 

To Report Fraud, Waste, and Abuse in Federal Programs: 

Contact: 

Web site: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]: 
E-mail: fraudnet@gao.gov: 
Automated answering system: (800) 424-5454 or (202) 512-7470: 

Congressional Relations: 

Ralph Dawn, Managing Director, dawnr@gao.gov: 
(202) 512-4400: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7125: 
Washington, D.C. 20548: 

Public Affairs: 

Chuck Young, Managing Director, youngc1@gao.gov: 
(202) 512-4800: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7149: 
Washington, D.C. 20548: