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United States Government Accountability Office: 
GAO: 

Testimony: 

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

For Release on Delivery: 
Expected 10:00 a.m. ET: 
Wednesday, July 16, 2014: 

High-Containment Laboratories: 

Recent Incidents of Biosafety Lapses: 

Statement of Nancy Kingsbury, Ph.D. 
Managing Director, Applied Research and Methods: 

GAO-14-785T: 

GAO Highlights: 

Highlights of GAO-14-785T, a testimony before the Subcommittee on 
Oversight and Investigations, Committee on Energy and Commerce, House 
of Representatives. 

Why GAO Did This Study: 

Recent biosecurity incidents-—such as the June 5, 2014, potential 
exposure of staff in Atlanta laboratories at the Centers for Disease 
Control and Prevention (CDC) to live spores of a strain of anthrax—-
highlight the importance of maintaining biosafety and biosecurity 
protocols at high-containment laboratories. This statement summarizes 
the results of GAO's past work on the oversight of high-containment 
laboratories, those designed for handling dangerous pathogens and 
emerging infectious diseases. Specifically, this statement addresses 
(1) the need for governmentwide strategic planning for the 
requirements for high-containment laboratories, including assessment 
of their risks; (2) the need for national standards for designing, 
constructing, commissioning, operating, and maintaining such 
laboratories; and (3) the oversight of biosafety and biosecurity at 
high-containment laboratories. In addition, it provides GAO's 
preliminary observations on the potential exposure of CDC staff to 
anthrax. For this preliminary work, GAO reviewed agency documents, 
including a report on the potential exposure, and scientific 
literature; and interviewed CDC officials. 

What GAO Found: 

No federal entity is responsible for strategic planning and oversight 
of high-containment laboratories. Since the 1990s, the number of high-
containment laboratories has risen; however, the expansion of high-
containment laboratories was not based on a government-wide 
coordinated strategy. Instead, the expansion was based on the 
perceptions of individual agencies about the capacity required for 
their individual missions and the high-containment laboratory 
activities needed to meet those missions, as well as the availability 
of congressionally approved funding. Consequent to this mode of 
expansion, there was no research agenda linking all these agencies, 
even at the federal level, that would allow for a national needs 
assessment, strategic plan, or coordinated oversight. As GAO last 
reported in 2013, after more than 12 years, GAO has not been able to 
find any detailed projections based on a government-wide strategic 
evaluation of research requirements based on public health or national 
security needs. Without this information, there is little assurance of 
having facilities with the right capacity to meet the nation's needs. 

GAO's past work has found a continued lack of national standards for 
designing, constructing, commissioning, and operating high-containment 
laboratories. As noted in a 2009 report, the absence of national 
standards means that the laboratories may vary from place to place 
because of differences in local building requirements or standards for 
safe operations. Some guidance exists about designing, constructing, 
and operating high-containment laboratories. Specifically, the 
Biosafety in Microbiological and Biomedical Laboratories guidance 
recommends various design, construction, and operations standards, but 
GAO's work has found it is not universally followed. The guidance also 
does not recommend an assessment of whether the suggested design, 
construction, and operational standards are achieved. As GAO has 
reported, national standards are valuable not only in relation to new 
laboratory construction but also in ensuring compliance for periodic 
upgrades. 

No one agency is responsible for determining the aggregate or 
cumulative risks associated with the continued expansion of high-
containment laboratories; according to experts and federal officials 
GAO interviewed for prior work, the oversight of these laboratories is 
fragmented and largely self-policing. 

On July 11, 2014, the Centers for Disease Control and Prevention (CDC) 
released a report on the potential exposure to anthrax that described 
a number of actions that CDC plans to take within its responsibilities 
to avoid another incident like the one in June. The incident in June 
was caused when a laboratory scientist inadvertently failed to 
sterilize plates containing samples of anthrax, derived with a new 
method, and transferred them to a facility with lower biosecurity 
protocols. This incident and the inherent risks of biosecurity 
highlight the need for a national strategy to evaluate the 
requirements for high-containment laboratories, set and maintain 
national standards for such laboratories' construction and operation, 
and maintain a national strategy for the oversight of laboratories 
that conduct important work on highly infectious pathogens. 

What GAO Recommends: 

This testimony contains no new recommendations, but GAO has made 
recommendations in prior reports to responsible agencies. We provided 
a draft of this statement to CDC for technical review and addressed 
their comments in the body of our statement where appropriate. 

View [hyperlink, http://www.gao.gov/products/GAO-14-785T]. For more 
information, contact Nancy Kingsbury at (202) 512-2700 or 
kingsburyn@gao.gov. 

[End of section] 

Chairman Murphy, Ranking Member DeGette, and Members of the 
Subcommittee: 

I am pleased to be here today to participate in today's hearing to 
address recent biosecurity incidents. On June 5, 2014, staff in 
Atlanta laboratories at the Centers for Disease Control and Prevention 
(CDC) were potentially exposed to live spores of the Ames strain of 
anthrax (Bacillus anthracis or B. anthracis). On July 1, 2014, at the 
Bethesda, Maryland, National Institutes of Health (NIH), vials of 
potentially live smallpox (variola) virus were unexpectedly 
discovered. Public attention is once again focused on the importance 
of maintaining biosafety and biosecurity protocols at high-containment 
laboratories.[Footnote 1] 

My statement summarizes the results of our past work on the oversight 
of high-containment laboratories and our preliminary assessment of the 
recent incident in Atlanta. Since 2007, we have reported on several 
issues associated with the proliferation of high-containment 
laboratories and risks posed by past biosafety incidents. The public 
is concerned about these laboratories because exposing workers and the 
public to dangerous pathogens, whether deliberate or accidental, can 
have disastrous consequences. Highly publicized laboratory errors and 
controversy about where high-containment laboratories should be 
located have raised questions about whether the governing framework, 
standards, and oversight for biosafety and biosecurity measures are 
adequate. 

This testimony is primarily based on GAO's past work on high-
containment laboratories. The issues in this work covered (1) the need 
for governmentwide strategic planning for the requirements for high-
containment laboratories, including assessment of their risks; (2) the 
need for national standards for designing, constructing, 
commissioning, operating, and maintaining such laboratories; and (3) 
the oversight of biosafety and biosecurity at high-containment 
laboratories. Each report cited in this statement provides detailed 
information on our work's objectives, scope, and methodology (the 
reports are listed at the end of this statement). For our preliminary 
observations, on the June 5-13, 2014 biosafety incident at CDC's 
laboratories we interviewed CDC officials and reviewed agency 
documents and scientific literature. We provided a draft of this 
statement to CDC for technical review and addressed their comments in 
the body of our statement where appropriate. We also reviewed CDC's 
July 11, 2014, Report on the Potential Exposure to Anthrax. The work 
this statement is based on was conducted 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 provided a reasonable basis for our findings and 
conclusions based on our audit objectives. 

No Federal Entity Is Responsible for Expansion and Oversight of High-
Containment Laboratories: 

The number of biosafety level (BSL)-3 and BSL-4 laboratories (high-
containment laboratories) began to rise in the late 1990s, 
accelerating after the anthrax attacks throughout the United States. 
The laboratories expanded across federal, state, academic, and private 
sectors. Information about their number, location, activities, and 
ownership is available for high-containment laboratories registered 
with CDC's Division of Select Agent and Toxins (DSAT) or the U.S. 
Department of Agriculture's (USDA) Animal and Plant Health Inspection 
Service (APHIS) as part of the Federal Select Agent Program. These 
entities register laboratories that work with select agents that have 
specific potential human, animal, or plant health risks. 

Other high-containment laboratories work with other pathogens that may 
also be dangerous but are not identified as "select agents" and 
therefore these laboratories are not required to register with DSAT or 
APHIS.[Footnote 2] We reported in 2009 that information about these 
non-select agent laboratories is not known. 

Our work has found that expansion of high-containment laboratories was 
not based on a government-wide coordinated strategy. The expansion was 
based on the perceptions of individual agencies about the capacity 
required for their individual missions and the high-containment 
laboratory activities needed to meet those missions, as well as the 
availability of congressionally approved funding. Decisions to fund 
the construction of high-containment laboratories were made by 
multiple federal agencies (e.g., Department of Health and Human 
Services (HHS), Department of Defense, USDA), in multiple budget 
cycles. Federal and state agencies, academia, and the private sector 
(such as drug companies) considered their individual requirements, but 
as we have previously reported a robust assessment of national needs 
was lacking. 

Since each agency or organization has a different mission, an 
assessment of needs, by definition, was at the discretion of the 
agency or organization. We have not found any national research agenda 
linking all these agencies, even at the federal level, that would 
allow for a national needs assessment, strategic plan, or coordinated 
oversight. As we last reported in 2013, after more than 12 years, we 
have not been able to find any detailed projections based on a 
government-wide strategic evaluation of research requirements based on 
public health or national security needs. Without this information, 
there is little assurance of having facilities with the right capacity 
to meet our national needs. This deficiency may be more critical today 
than 5 years ago when we first reported on this concern because 
current budget constraints make prioritization essential. 

National Standards for Designing, Constructing, Commissioning, 
Operating, and Maintaining High-Containment Laboratories Are Needed: 

Our work on this issue has found a continued lack of national 
standards for designing, constructing, commissioning, and operating 
high-containment laboratories. These laboratories are expensive to 
build, operate, and maintain. For example, we noted in our 2009 report 
that the absence of national standards means that the laboratories may 
vary from place to place because of differences in local building 
requirements or standards for safe operations. In 2007, while 
investigating a power outage at one of its recently constructed BSL-4 
laboratory, CDC determined that construction workers digging at an 
adjacent site had some time earlier cut a critical grounding cable 
buried outside the building. CDC facility managers had not noticed 
that cutting the grounding cable had compromised the electrical system 
of the facility that housed the BSL-4 laboratory. It became apparent 
that the building's integrity as it related to the adjacent 
construction had not been adequately supervised. In 2009, CDC 
officials told us that standard procedures under local building codes 
did not require monitoring of the new BSL-4 facility's electrical 
grounding. This incident highlighted the risk of relying on local 
building codes to ensure the safety of high-containment laboratories 
in the absence of national standards or testing procedures specific to 
those laboratories.[Footnote 3] 

Some guidance exists about designing, constructing, and operating high-
containment laboratories. The Biosafety in Microbiological and 
Biomedical Laboratories guidance, often referred to as BMBL recommends 
various design, construction and operations standards, but our work 
has found it is not universally followed.[Footnote 4] It also does not 
recommend an assessment of whether the suggested design, construction, 
and operations standards are achieved. As we have recommended, 
national standards would be valuable for not only new laboratory 
construction but also periodic upgrades. Such standards need not be 
constrained in a "one-size fits all" model but could help specify the 
levels of facility performance that should be achieved. 

Risks Associated with Expanding High-Containment Laboratories and 
Oversight Challenges: 

Our work has also found that no executive or legislative mandate 
directs any federal agency to track the expansion of all high-
containment laboratories. While federal agency officials and experts 
agree that operating high-containment laboratories is always 
associated with some risk, no one agency is responsible for 
determining the aggregate or cumulative risks associated with the 
continued expansion of these laboratories. According to the experts 
and federal officials we have interviewed for our prior work, the 
oversight of these laboratories is fragmented and largely relies on 
self-policing. For example, if an entity is registered under the 
Federal Select Agent Program, CDC DSAT or APHIS provides oversight. 
However, if an entity receives federal funding from the National 
Institutes of Health for recombinant deoxyribonucleic acid (rDNA) 
research, the NIH Office of Biotechnology Activities provides 
oversight. DOD also separately funds and inspects high-containment 
laboratories. These agencies assume that risks will be dealt with by 
the entities' self-regulation, consistent with the laboratory practice 
guidelines developed by the funding or regulatory agencies. In 2013, 
we reported that another challenge of this fragmented oversight is the 
potential duplication and overlap of inspection activities in the 
regulation of high-containment laboratories.[Footnote 5] We 
recommended that CDC and APHIS work with the internal inspectors for 
Department of Defense and Department of Homeland Security to 
coordinate inspections and ensure the application of consistent 
inspection standards. 

According to most experts that we have spoken to in the course of our 
work, a baseline risk is associated with any high-containment 
laboratory. Although technology and improved scientific practice 
guidance have reduced the risk in high-containment laboratories, the 
risk is not zero (as illustrated by the recent incidents and others 
during the past decade). According to CDC officials, the risks from 
accidental exposure or release can never be completely eliminated and 
even laboratories within sophisticated biological research programs--
including those most extensively regulated--has and will continue to 
have safety failures. Many experts agree that as the number of high-
containment laboratories has increased, so the overall risk of an 
accidental or deliberate release of a dangerous pathogen will also 
increase.[Footnote 6] 

Oversight is critical in improving biosafety and ensuring that high-
containment laboratories comply with regulations. However, our work 
has found that aspects of the current oversight programs provided by 
DSAT and APHIS depend on entities' monitoring themselves and reporting 
incidents to the regulators. For example, with respect to a 
certification that a select agent had been rendered sterile (that is, 
noninfectious), DSAT officials told us, citing the June 2014 updated 
guidance, that "the burden of validating non-viability and non-
functionality remains on the individual or entity possessing the 
select agent, toxin, or regulated nucleic acid." [Footnote 7] While 
DSAT does not approve each entity's scientific procedure, DSAT 
strongly recommends that "an entity maintain information on file in 
support of the method used for rendering a select agent non-viable ... 
so that the entity is able to demonstrate that the agent ... is no 
longer subject to the select agent regulations." Biosafety select 
agent regulations and oversight critically rely on laboratories 
promptly reporting any incidents that may expose employees or the 
public to infectious pathogens. Although laboratories have been 
reasonably conscientious about reporting such incidents, there is 
evidence that not all have been reported promptly. 

The June 2014 Incident at the CDC Laboratories and GAO's Preliminary 
Observation: 

The June 2014 incident in which live anthrax bacteria were transferred 
from a BSL-3 contained environment to lower-level (BSL-2) containment 
laboratories at CDC in Atlanta resulted in the potential exposure of 
tens of workers to the highly virulent Ames strain of anthrax. 
According to CDC's report, on June 5, a laboratory scientist in the 
BSL-3 Bioterrorism Rapid Response and Advanced Technology (BRRAT) 
laboratory prepared protein extracts from eight bacterial select 
agents, including Bacillus anthracis, under high-containment (BSL-3) 
conditions.[Footnote 8] These samples were being prepared for analysis 
by matrix-assisted laser desorption/ionization time-of-flight (MALDI-
TOF) mass spectrometry, a relatively new technology that can be used 
for rapid bacterial species identification. Also, according to CDC 
officials that we spoke to this protein extraction procedure was being 
evaluated in a preliminary assessment of whether MALDI-TOF mass 
spectrometry could provide a cheaper and faster way to detect a range 
of pathogenic agents, including anthrax, compared to conventional 
methods and thus could be used by emergency response laboratories. 
According to CDC officials, the researchers intended to use the data 
collected in this experiment to submit a joint proposal to CDC's 
Office of Public Health Preparedness and Response to fund further 
evaluation of the MALDI TOF method because MALDI TOF is increasingly 
being used by clinical and hospital laboratories for infectious 
disease diagnostics. 

The protein extraction procedure was chemically based and intended to 
render the pathogens noninfectious, which alternative extraction 
procedures would have done using heat, radiation, or other chemical 
treatments that took longer. The procedure that was used to extract 
the proteins was not based on a standard operating procedure that had 
been documented as appropriate for all the pathogens in the experiment 
and reviewed by more senior scientific or management officials. 
Rather, the scientists used a procedure identified by the MALDI TOF 
equipment manufacturer that had not been tested for effectiveness, in 
particular, for rendering spore-forming organisms such as anthrax 
noninfectious. Following that procedure, the eight pathogens were 
exposed to chemical treatment for 10 minutes and then plated (spread 
on plates to test for sterility or noninfectious status) and incubated 
for 24 hours. According to CDC, on June 6, when no growth was observed 
on sterility plates after 24 hours, the remaining samples, which had 
been held in the chemical solution for 24 hours, were moved to CDC BSL-
2 laboratories for testing using the MALDI TOF technology. 
Importantly, the plates containing the original sterility samples were 
left in the incubation chamber rather than destroyed as would normally 
occur because of technical problems with the autoclave that would have 
been used for destruction. 

According to CDC officials, on June 13, a laboratory scientist in the 
BRRAT laboratory observed unexpected growth on the anthrax sterility 
plate, possibly indicating that the sample was still infectious. (All 
the other pathogen protein samples showed no evidence of growth.) That 
scientist and a colleague immediately reported the discovery to the 
CDC Select Agent Responsible Official (RO) in accordance with the 
BRRAT Laboratory Incident Response Plan. That report triggered a 
response that immediately recovered the samples that had been sent to 
the BSL-2 laboratories and returned them to BSL-3 containment, and a 
response effort that lasted a number of days was implemented to 
identify any CDC employees who might have been affected by exposure to 
live anthrax spores. (The details of the subsequent actions and CDC's 
lessons learned and proposed actions are described in CDC's July 11, 
2014, Report on Potential Exposure to Anthrax. That report indicates 
that none of the potentially affected employees experienced anthrax-
related adverse medical symptoms.) 

Our preliminary analysis indicates that the BRRAT laboratory was using 
a MALDI-TOF MS method that had been designed for protein extraction 
but not for the inactivation of pathogens and that it did not have a 
standard operating procedure (SOP) or protocol on inactivation. We did 
not find a complete set of SOPs for removing agents from a BSL-3 
laboratory in a safe manner. Further, neither the preparing (BRRAT BSL-
3) laboratory nor the receiving laboratory (BRRAT BSL-2) laboratory 
conducted sterility testing. Moreover, the BRRAT laboratory did not 
have a kill curve based on multiple concentration levels. [Footnote 9] 

When we visited CDC on July 8, it became apparent to us, that a major 
cause of this incident was the implementation of an experiment to 
prepare protein extractions for testing using the MALDI TOF technology 
that was not based on a validated standard operating procedure. 
[Footnote 10] CDC officials acknowledged that significant and relevant 
studies in the scientific literature about chemical procedures studied 
for preparing protein samples for use in the MALDI TOF technology, 
were successful in rendering tested pathogens noninfectious, except 
for anthrax. The literature clearly recommends an additional filtering 
step before concluding that the anthrax samples are not infectious. 
Our preliminary work indicates that this step was not followed for all 
the materials in this incident. 

In response to a 2004 inadvertent exposure to anthrax spores at 
Children's Hospital Oakland Research Institute in California, where 
laboratory workers were evaluating the immune response of mice to B. 
anthracis, CDC conducted an investigation along with the California 
Department of Health Services. This investigation found that workers 
in a research laboratory unknowingly received and used a suspension 
from a contract laboratory that likely contained viable B. anthracis 
organisms, although the pathogen was supposed to have been 
inactivated. CDC's investigation report of that incident stated that 
inactivated suspensions of B. anthracis should be cultured both at the 
preparing laboratory before shipment and at the research laboratory 
receiving the suspension before use to ensure sterility (that the 
material is noninfectious). The hospital staff did not perform 
sterility testing on the suspension received in March 2004. 

CDC's 2004 report further stated that "Research laboratory workers 
should assume that all inactivated B. anthracis suspension materials 
are infectious until inactivation is adequately confirmed [using BSL-2 
laboratory procedures]." These recommendations are relevant to the 
June 2014 incident in Atlanta but were not followed. The laboratories 
receiving the protein extractions were BSL-2 laboratories, but the 
activities associated with testing with the MALDI TOF technology were 
conducted on open laboratory benches, not using biocontainment 
cabinets otherwise available in such laboratories. 

CDC's July 11, 2014, Report on the Potential Exposure to Anthrax 
describes a number of actions that CDC plans to take within its 
responsibilities to avoid another incident like the one in June. 
However, we continue to believe that a national strategy is warranted 
that would evaluate the requirements for high-containment 
laboratories, set and maintain national standards for such 
laboratories' construction and operation, and maintain a national 
strategy for the oversight of laboratories that conduct important 
research on highly infectious pathogens. 

This completes my formal statement, Chairman Murphy, Ranking Member 
DeGette and members of the committee. I am happy to answer any 
questions you may have. 

GAO Contact and Staff Acknowledgments: 

For future contacts regarding this statement, please contact Nancy 
Kingsbury at (202) 512-2700 or at kingsburyn@gao.gov. Contact points 
for our Offices of Congressional Relations and Public Affairs may be 
found on the last page of this statement. Sushil Sharma, Ph.D., Dr.PH, 
Assistant Director; and Elaine L. Vaurio also made key contributions 
to this statement. 

[End of section] 

Related GAO Products: 

High-Containment Laboratories: Assessment of the Nation's Need Is 
Missing. [hyperlink, http://www.gao.gov/products/GAO-13-466R]. 
Washington, D.C.: February 25, 2013. 

Biological Laboratories: Design and Implementation Considerations for 
Safety Reporting Systems. [hyperlink, 
http://www.gao.gov/products/GAO-10-850]. Washington, D.C.: September 
10, 2010. 

High-Containment Laboratories: National Strategy for Oversight Is 
Needed. [hyperlink, http://www.gao.gov/products/GAO-09-1045T]. 
Washington, D.C.: September 22, 2009. 

High-Containment Laboratories: National Strategy for Oversight Is 
Needed. [hyperlink, http://www.gao.gov/products/GAO-09-1036T]. 
Washington, D.C.: September 22, 2009. 

High-Containment Laboratories: National Strategy for Oversight Is 
Needed. [hyperlink, http://www.gao.gov/products/GAO-09-574]. 
Washington, D.C.: September 21, 2009. 

Biological Research: Observations on DHS's Analyses Concerning Whether 
FMD Research Can Be Done as Safely on the Mainland as on Plum Island. 
[hyperlink, http://www.gao.gov/products/GAO-09-747]. Washington, D.C.: 
July 30, 2009. 

High-Containment Biosafety Laboratories: DHS Lacks Evidence to 
Conclude That Foot-and-Mouth Disease Research Can Be Done Safely on 
the U.S. Mainland. [hyperlink, 
http://www.gao.gov/products/GAO-08-821T]. Washington, D.C.: May 22, 
2008. 

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.: October 4, 
2007. 

Biological Research Laboratories: Issues Associated with the Expansion 
of Laboratories Funded by the National Institute of Allergy and 
Infectious Diseases. [hyperlink, 
http://www.gao.gov/products/GAO-07-333R]. Washington, D.C.: February 
22, 2007. 

Homeland Security: CDC's Oversight of the Select Agent Program 
[hyperlink, http://www.gao.gov/products/GAO-03-315R]. Washington, 
D.C.: November 22, 2002. 

[End of section] 

Footnotes: 

[1] High-containment laboratories--commonly referred to as biosafety 
level (BSL)-3 and BSL-4 laboratories--are designed for handling 
dangerous pathogens (which might accidentally or intentionally be 
released into the environment) and emerging infectious diseases for 
which risks may not be clearly understood. Some use "high-and maximum-
containment laboratories" to refer to BSL-3 and BSL-4 laboratories. 
"Animal biosafety level (ABSL)-3 and ABSL-4" mean laboratories that 
work with animals infected with indigenous or exotic agents. "BSL-3 
Ag" describes laboratories where studies employ large agricultural 
animals. In this statement, "high-containment laboratories" refers to 
all these types of laboratories. 

[2] A select agent is a biological agent or toxin that (1) potentially 
poses a severe threat to public health and safety, animal or plant 
health, and animal or plant products and (2) is regulated by select 
agent rules for possession, use, and transfer (7 C.F.R. Part 331, 9 
C.F.R. Part 121, and 42 C.F.R. Part 73). CDC and USDA maintain a list 
of select agents and toxins. 

[3] GAO recommended in our 2013 report that the Executive Office of 
the President, Office of Science and Technology Policy (OSTP) examine 
the need to establish national standards relating to designing, 
constructing, commissioning, maintaining, and operating high-
containment laboratories. OSTP concurred. 

[4] Department of Health and Human Services (Washington, D.C., 2007), 
Biosafety in Microbiological and Biomedical Laboratories, 5th ed. HHS 
has developed and provided biosafety guidelines outlined in this 
manual. 

[5] High-Containment Laboratories: Assessment of the Nation's Need Is 
Missing, [hyperlink, http://www.gao.gov/products/GAO-13-466R] 
(Washington, D.C.: February 25, 2013). 

[6] The Office of Science and Technology Policy (OSTP), Executive 
Office of the President, disagreed with our assessment in our 2013 
report of the increased overall risk associated with the expansion of 
high-containment laboratories. Officials did not agree that there was 
an increased risk. Our assessment is based on probability theory, and 
we make no assumptions about the magnitude (size or extent) of the 
increase. The risk associated with any single laboratory is nonzero, 
for example, as laboratory accidents happen. Even where newer safety 
controls reduce the risk of an accident for any individual laboratory, 
and even if the number of accidents at any laboratory is small, when 
the number of laboratories increases, each laboratory's risk adds to 
the overall risk of an accident's happening nationwide. Because 
laboratories operate independently, the risk is not increased for each 
laboratory. The risk at each laboratory leads to an overall increased 
risk with expansion. 

[7] National Select Agent Registry. "Non-viable Select Agents and 
Nonfunctional Select Toxins and Rendering Samples Free of Select 
Agents and Toxins." June 16, 2014. It is guidance for the inactivation 
of select agents and toxins. 

[8] CDC." Report on the Potential Exposure to Anthrax." July 11, 2014. 

[9] A kill curve is a graph in which the number of viable organism is 
plotted against time. A kill curve's shape depends on the 
concentration of chemicals that the organisms are exposed to. 

[10] Validating a procedure or method provides a defined level of 
statistical confidence in the results of the procedure or method. 

[End of section] 

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U.S. Government Accountability Office: 
441 G Street NW, Room 7125: 
Washington, DC 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, DC 20548. 

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