Anthrax Detection: DHS Cannot Ensure That Sampling Activities	 
Will Be Validated (29-MAR-07, GAO-07-687T).			 
                                                                 
In September and October 2001, contaminated letters laced with	 
Bacillus anthracis were sent through the mail to two U.S.	 
senators and members of the media. Postal facilities in New	 
Jersey, Washington, D.C., and elsewhere became heavily		 
contaminated. The anthrax incidents highlighted major gaps in	 
civilian preparedness to detect anthrax contamination in	 
buildings. GAO was asked to describe and assess federal agencies'
activities to detect anthrax in postal facilities, assess the	 
results of agencies' testing, and assess whether agencies'	 
detection activities were validated.				 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-07-687T					        
    ACCNO:   A67464						        
  TITLE:     Anthrax Detection: DHS Cannot Ensure That Sampling       
Activities Will Be Validated					 
     DATE:   03/29/2007 
  SUBJECT:   Accountability					 
	     Anthrax						 
	     Biological warfare 				 
	     Collection procedures				 
	     Contamination					 
	     Disease detection or diagnosis			 
	     Evaluation methods 				 
	     Federal facilities 				 
	     Homeland security					 
	     Internal controls					 
	     Investigations by federal agencies 		 
	     Postal facilities					 
	     Strategic planning 				 
	     Testing						 
	     Policies and procedures				 
	     Affirmative responsibility 			 
	     determinations					 
                                                                 

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GAO-07-687T

   

     * [1]Results in Brief
     * [2]Background
     * [3]Major Findings

          * [4]Sampling Strategy
          * [5]Sampling Methods
          * [6]Results of Testing
          * [7]Conclusions

     * [8]Recommendations for Executive Action
     * [9]Who Is Responsible for Ensuring and Guaranteeing That Anthra
     * [10]Contacts and Acknowledgments
     * [11]GAO's Mission
     * [12]Obtaining Copies of GAO Reports and Testimony

          * [13]Order by Mail or Phone

     * [14]To Report Fraud, Waste, and Abuse in Federal Programs
     * [15]Congressional Relations
     * [16]Public Affairs

Testimony before the Subcommittee on Homeland Security, Committee on
Appropriations, House of Representatives

United States Government Accountability Office

GAO

For Release on Delivery Expected at 10:00 a.m. EDT
Thursday, March 29, 2007

ANTHRAX DETECTION

DHS Cannot Ensure That Sampling Activities Will Be Validated

Statement of Keith Rhodes, Chief Technologist, Center for Technology and
Engineering Applied Research and Methods

GAO-07-687T

Mr. Chairman and Members of the Subcommittee:

We are pleased to be here today to discuss our findings on anthrax
detection testing. The threat of bioterrorism has been recognized for a
considerable time. Long before the anthrax attacks of 2001, several hoax
letters indicating the presence of anthrax had been mailed to federal and
state agencies, as well as to private sector organizations. These events
raised the possibility that facilities could become contaminated and would
therefore have to be evaluated for environmental contamination. However,
federal agencies were not fully prepared to deal with environmental
contamination--that is, anthrax released through the mail--including the
potential for multiple dispersals in indoor environments.

In September and October 2001, contaminated letters laced with Bacillus
anthracis were sent through the mail to two U.S. senators, Thomas Daschle
and Patrick Leahy, and members of the media.1 The postal facilities in New
Jersey and Washington, D.C., that processed the senators' letters became
heavily contaminated. Other mail routed through these facilities, as well
as additional facilities in the postal network, also became contaminated.
In addition, numerous federal facilities in the Washington, D.C., area
were later found to be contaminated. The letters led to the first cases of
anthrax disease related to bioterrorism in the United States. In all, 22
individuals contracted anthrax disease in four states--Connecticut,
Florida, New Jersey, and New York--as well as in Washington, D.C. Five of
these 22 individuals died.

The anthrax incidents in September and October 2001 highlighted major gaps
in civilian preparedness to detect and respond. In today's testimony, I
will discuss our findings concerning anthrax sampling activities,
recommendations we made, and a major issue we identified--the Department
of Homeland Security (DHS) cannot ensure and guarantee that sampling
activities will be validated.

1Bacillus anthracis is the microorganism that causes the disease known as
anthrax.

In developing this testimony, we relied on our prior work.2 We conducted
our review in accordance with generally accepted government auditing
standards.

Results in Brief

Federal agencies responsible for responding to the 2001 anthrax incidents
adopted a targeted sampling strategy that they based on their best
judgment at the time. They primarily collected samples from specific
areas, such as mail-processing areas, using their judgment about where
anthrax would most likely be found. Such judgments can be effective in
some situations--for example, in determining whether a facility is
contaminated when information on the source of potential contamination is
definitive. However, in the case of a negative finding, when the source of
potential contamination is not definitive, the basic question--Is this
building contaminated?--will remain unanswered. Therefore, in the case of
a negative result, a different strategy, probability sampling, is needed.
Probability sampling would have allowed agencies to determine whether the
building was contaminated with some defined level of confidence.

The federal agencies--CDC, EPA, and USPS--involved in sampling the postal
facilities in 2001 to detect anthrax undertook several activities. These
included development of a sampling strategy followed by collection of
samples using a variety of methods, transporting and extracting, and
analysis of the samples. Neither these activities nor the overall process
was validated for anthrax testing. Consequently, the agencies were
challenged by the limited information available for reliably choosing one
method over another and the lack of information on the detection limit to
use when evaluating negative results.

The results of the CDC, EPA, and USPS testing in 286 postal facilities
were largely negative.3 Of the 286 facilities, 23 tested positive. For 2
of these 23 facilities, test results were negative at first but positive
on a subsequent testing. However, in 1 of these facilities--the
Wallingford, Connecticut, facility--it was not until the fourth testing
that positive results were obtained.

2GAO, Anthrax Detection: Agencies Need to Validate Sampling Activities in
Order to Increase Confidence in Negative Results, [17]GAO-05-251
(Washington D.C.: Mar 27, 2005); Anthrax Detection: Agencies Need to
Validate Sampling Activities in Order to Increase Confidence in Negative
Results, [18]GAO-05-493T (Washington D.C.: Apr. 5, 2005); and Anthrax:
Federal Agencies Have Taken Some Steps to Validate Sampling Methods and to
Develop a Next-Generation Anthrax Vaccine, [19]GAO-06-756T (Washington
D.C.: May 9, 2006).

3While the Federal Bureau of Investigation (FBI) also collected samples,
we did not include the results of its testing due to its ongoing criminal
investigation.

The federal agencies' activities to detect anthrax contamination were not
validated. Without validation, the sampling activities could have been
based on false assumptions.

For example, the lack of validated sample collection methods means that it
is not known how many spores a particular method will collect from a
surface and, thus, which method is appropriate for a given situation.
Using an ineffective method or procedure could result in a finding of no
contamination when in fact there is contamination--a false negative.

Validating the overall process, as well as the individual activities, is
important because operational and health-related decisions are made on the
basis of testing results generated by that process. In addition,
validation would offer assurance that the results of using a particular
method, which is part of that process, are robust enough to be reproduced,
regardless of which agency, contractor, or laboratory is involved. Thus,
agencies and the public could be reasonably confident that any test
results generated by a process that includes that method would be reliable
and, in particular, that any negative results would mean that a sample was
free from contamination (within the method's limits of detection).

Given the lack of validated methods for detecting anthrax contamination in
facilities, we recommended that the Secretary of Homeland Security develop
a coordinated approach to (1) improve the overall process for detecting
anthrax and (2) increase confidence in negative test results generated by
that process. This approach would include working with agencies to ensure
that appropriate validation studies of the overall process of sampling
activities, including the methods, are conducted. Specifically, we
recommended that the Secretary

           1. take a lead role in promoting and coordinating the activities
           of the various agencies that have the technical expertise related
           to environmental testing;
           2. ensure that a definition of validation is developed and agreed
           on;
           3. guarantee that the overall process of sampling activities,
           including methods, is validated so that performance
           characteristics, including limitations, are clearly understood and
           results can be correctly interpreted;
           4. see that appropriate investments are made in empirical studies
           to develop probability-based sampling strategies that take into
           account the complexities of indoor environments;
           5. ensure that appropriate, prioritized investments are made for
           all biothreat agents; and
           6. make sure that agency policies, procedures, and guidelines
           reflect the results of such efforts.4

When we issued our report, CDC, DHS, and USPS agreed with our
conclusion--that methods for detecting anthrax contamination in facilities
were not validated--and with the thrust of our recommendations--calling
for a coordinated, systematic effort to validate the methods to be used
for such testing. But they (1) disagreed with or expressed concern about
our conclusions or the recommendation dealing with targeted versus
probability sampling, (2) emphasized that validated testing methods for
anthrax were not available in 2001 and that federal and state
organizations did the best they could under the circumstances, and (3)
identified factors or issues that need to be considered in validating
testing methods.

In addition, uncertainty over which agency would take the lead role--that
is, who is in charge--in improving the overall process for detecting
anthrax, and how studies were to be funded, continued after we issued our
report. DHS stated that while it has overall responsibility for
coordinating the federal response during future biological attacks, EPA
had the "primary responsibility for establishing the strategies,
guidelines, and plans for the recovery from a biological attack," while
the Department of Health and Human Services (HHS) had the lead role for
any related public health response and guidelines. DHS also stated that it
coordinated regularly with EPA's National Homeland Research Center to
exchange information on research needs and to discuss priorities and gaps
for a wide range of security-related research areas. DHS stated that it
would coordinate with EPA to ensure that appropriate investments were made
to explore improved sampling. However, it is unclear to us how DHS would
ensure that appropriate prioritized investments are made for all biothreat
agents and how such priorities and gaps would be addressed.

4 [20]GAO-05-251 , pp. 82-83.

On the basis of these uncertainties, we recommended in our May 9, 2006,
testimony that DHS's approach to validating the overall process start with
a strategic plan that includes a road map outlining how individual
agencies' efforts would lead to the validation of the individual
activities as well as the overall process, noting that such a plan would
assist DHS in monitoring progress and measuring agency performance toward
improving the detection of anthrax and other prioritized threat agents. 5

On May 19, 2006, DHS officials stated that DHS cannot ensure and guarantee
that validation studies would be done, since this is a shared
responsibility among different agencies. DHS stated that "there are legal
limitations in DHS authority to direct the activities of other agencies."
Also, since validation would require a sustained effort over a long
period, these officials noted that they could not mandate commitment of
other agencies' funds, because of legal and budgetary limitations.

DHS officials told us in July 2006 that they recognize that DHS is the
principal agency responsible for coordinating the federal response and
they would work with a good faith effort toward developing a strategy for
validation studies and a road map by the end of calendar year 2006,
outlining how individual agencies' efforts would lead to the validation of
the overall sampling process. On March 27, 2007, DHS told us that it had
developed a working draft of the strategic plan and the road map by
December 2006 but it could not share these with us because they were not
final.6

Until responsibility is accepted for ensuring that sampling activities
will be validated, the fate of the validation process will remain
uncertain. Without validation, if another anthrax attack were to occur
tomorrow, federal civilian agencies would not be able to conclude with any
given level of statistical confidence, in cases of negative results, that
a building is free of contamination.

Background

In October 2001, an American Media Incorporated employee died from
inhalation anthrax disease. In the same month, contaminated letters laced
with Bacillus anthracis, or anthrax spores, were sent through the mail to
Senators Thomas Daschle and Patrick Leahy. The response to the incident in
the American Media Incorporated building in Florida in September 2001 led
to the identification of mail as the potential source of contamination;
eventually, it led to the sampling of the postal facilities. The agencies
began sampling on October 12, 2001, in Florida and stopped on April 21,
2002, when the Wallingford, Connecticut, facility was sampled for the last
time. The letters led to the first cases of anthrax disease related to
bioterrorism in the United States. In all, 22 individuals contracted
anthrax disease in Connecticut, Florida, New Jersey, and New York, as well
as in Washington, D.C., and 5 died.

5 [21]GAO-06-756T

6Also on March 27, 2007, DHS officials gave us a short status report on
the Anthrax Sampling Working Group. However, we could not evaluate the
significance of the activities it summarized without the strategic plan.

The federal agencies involved in the response in the postal facilities
have different responsibilities. CDC and state and local health
departments primarily provided public health advice and assistance to
USPS. CDC has primary responsibility for national surveillance of specific
diseases, including anthrax; it also conducts epidemiologic investigations
to determine, among other things, the source of the disease, and it
participates in environmental sample collection and analysis activities.
The FBI is responsible for criminal investigations involving interstate
commerce and the mail and crimes committed on federal property. EPA is the
nation's lead agency for responding to a release of hazardous substances
into the environment and subsequent decontamination.

On October 8, 2001, the President created the Office of Homeland Security
to develop and coordinate a comprehensive national strategy for dealing
with domestic terrorist threats or attacks. The office, which had limited
involvement in the 2001 response, was superseded by the Homeland Security
Act of 2002, which transferred many of its functions to DHS, which became
operational in 2003. DHS was created by combining many previously separate
agencies and is assigned a lead role in coordinating the efforts of
federal agencies that respond to acts of terrorism in the United States.

Major Findings

Sampling Strategy

The federal agencies primarily used a targeted strategy--they collected
samples from specific areas considered more likely to be contaminated,
based on judgments. Such judgments can be effective in some
situations--for example, in determining whether a facility is contaminated
when information on the source of potential contamination is definitive.
However, in the case of a negative finding, when the source of potential
contamination is not definitive, the basic question--Is this building
contaminated?--will remain unanswered.

CDC and USPS officials said that they used a targeted strategy for several
reasons, including limitations on how many samples could be collected and
analyzed. They also said that in 2001, they lacked the data from empirical
research to develop an initial sampling strategy that incorporated
probability sampling. We disagree with this interpretation. Probability
sampling is statistically based and does not depend solely on empirical
criteria regarding the details of possible contamination.

The situation in 2001 was unique, and the agencies were not fully prepared
to deal with environmental contamination. In the future, if the agencies
decide to use a targeted rather than a probability sampling strategy, they
must recognize that they could lose a number of days if their targeted
sampling produces negative test results. In this case, additional samples
would have to be collected and analyzed, resulting in the loss of critical
time for public health interventions. This was so at the Wallingford
postal facility in the fall of 2001, when about 3 weeks elapsed between
the time the first sampling took place and the results of the fourth
testing, which revealed positive results. Furthermore, about 5 months
elapsed between the time of the first sampling event and the time anthrax
was found in the Wallingford facility's high-bay area.

Therefore, strategies that include probability sampling need to be
developed in order to provide statistical confidence in negative results.
Further, even if information on all the performance characteristics of
methods is not yet available, a probability sampling strategy could be
developed from assumptions about the efficiency of some of the methods.
And even if precise data are not available, a conservative, approximate
number could be used for developing a sampling strategy. This would give
agencies and the public greater confidence in negative test results than
was associated with the sampling strategy used in 2001.

Sampling Methods

CDC, EPA, and USPS, the federal agencies involved in sampling the postal
facilities in 2001 to detect anthrax, undertook several activities. These
included development of a sampling strategy followed by collecting
samples, using a variety of methods, and transporting, extracting, and
analyzing the samples. Neither these activities nor the overall process
was validated for anthrax testing. Consequently, the agencies were
challenged by limited information for reliably choosing one method over
another and by lack of information on the detection limit to use when
evaluating negative results.

Federal agencies used different methods for collecting samples. While USPS
generally used dry swabs to collect samples (the least effective method),
CDC and EPA used multiple methods--dry swabs, premoistened swabs, wet
wipes, and a high-efficiency particulate air (HEPA) vacuum--in various
combinations or alone.

However, none of the agencies' collection methods were evaluated for
anthrax detection in environmental samples. In the absence of empirical
research, agencies had no information available for reliably choosing one
method over another and no information on the limits of detection to use
when evaluating negative results.

Results of Testing

The majority of the samples collected from the postal facilities tested
negative. In all, federal agencies collected about 10,000 samples during
initial testing. It is interesting that of the 9,807 samples that the
agencies collected, more than 98 percent, or 9,648, were negative; a
little more than 1 percent, or 159, were positive. In all, 286 facilities
were tested for anthrax contamination. Of these, Brentwood, Trenton, and
Morgan were primary facilities; that is, these 3 facilities processed the
original letters containing the anthrax.

The results of the CDC, EPA, and USPS testing in 286 postal facilities
were largely negative. Of 286 facilities, 23 tested positive. For 2 of
these 23 facilities, test results were negative at first but positive on a
subsequent testing. However, in 1 of these facilities--the Wallingford,
Connecticut, facility--it was not until the fourth testing that positive
results were obtained.

Testing results differed between the primary facilities and Wallingford.
In the 3 primary facilities, results were positive each time a facility
was tested, with the important exception of the two quick tests in
Brentwood. In Wallingford, considered less likely to be contaminated,
results were positive only on the fourth sampling. These results
underscore the importance of retesting and cast doubt on the efficiency of
the judgmental sampling strategy.

Of the 263 facilities that tested negative, only 9 were sampled more than
once. A facility in West Trenton tested negative, even though an employee
had contracted cutaneous anthrax. The facility in West Trenton was tested
twice by the FBI and once by CDC, during which a total of 57 samples were
collected, with negative results.

Final, or confirmed, results will be negative if contamination is not
present in a facility. However, a result can be erroneously negative for
several other reasons, such as (1) the sampling method was not efficient
enough, (2) samples were not collected from places where contamination was
present, (3) not enough samples were collected, (4) not enough spores were
recovered from the sample material, or (5) analysis of the sample extract
was not sensitive enough to detect anthrax spores that were present.

Conclusions

The agencies that sampled postal facilities in 2001--USPS, CDC, and
EPA--did not use validated sample collection and analysis methods to
perform their tests. According to these agencies, validated methods were
not available at that time. They conducted several interdependent
activities, including sample strategy development, followed by sample
collection, transportation, and analysis of the samples to detect anthrax.
Neither these activities nor the overall process had been validated for
anthrax testing.

Validation is a formal, empirical process in which an authority determines
and certifies the performance characteristics of a given method.
Therefore, investments are also needed to validate these methods, as well
as the overall anthrax detection process. Validating the overall process,
as well as the individual activities, is important because operational and
health-related decisions are made on the basis of testing results that the
process generates.

CDC and USPS officials said that they used targeted sampling; that is,
they collected samples from specific areas considered--based on agencies'
technical judgments--more likely to be contaminated. Such judgments can be
effective in some situations, for example, in determining the source of
contamination in a disease outbreak investigation, provided results are
positive. However, if the results are negative, the basic question--Is
this building contaminated?--cannot be answered with statistical
confidence.

When the level of contamination is extremely high and dispersed in a
facility, the method of sampling (for example, wipes versus swabs) is not
as critical if the purpose is to find some contaminant. However, at lower
levels, a way of interpreting the significance of negative results is
needed, and this requirement emphasizes the importance of validation of
the methods and the need for statistically based sampling strategies. This
emphasizes the need for methods that have been validated, and sampling
strategies that are likely to find contamination at low levels.
Probability-based sampling does allow conclusions, at specific levels of
confidence, about testing results.

Using a probability-based sampling strategy, together with validated
methods for detecting contamination, would provide a known level of
confidence with which to interpret any negative results. This would allow
agencies to be more definitive in determining necessary actions. Figure 1
shows how lack of validation could affect individual activities--including
the sampling strategy--as well as the results generated by the overall
process.

Figure 1: Lack of Validation Can Affect Individual Activities and the
Overall Process

The lack of validated methods for assessing contamination in postal
facilities impeded the agencies in responding to the incidents. The
significance of the lack of validated methods was exemplified in the case
of the one postal facility where negative preliminary results were
obtained by field-based methods of analysis, with limitations that appear
not to have been well understood by some agencies. Negative results do not
necessarily mean a facility is free from contamination. As we reported,
results can be negative if (1) samples were not collected from places
where anthrax was present, (2) the detection limit of the method was
greater than the actual contamination level, (3) not enough samples were
recovered from the sample material, (4) analysis of the sample extract did
not detect spores, or (5) anthrax was not present in the facility.

In addition, while the 2001 events involved anthrax, many other biothreat
agents exist. Differences in their characteristics mean different
solutions. Accordingly, efforts to develop sampling strategies and to
validate methods should address requirements specific to those threat
agents as well. However, since addressing other agents would consume
resources and time, all these efforts should be prioritized in a long-term
strategy.

The several agencies that dealt with the anthrax attacks generally worked
well together, but we have identified areas that would have benefited from
one agency's taking the lead in coordinating the response. Given the
mission of DHS and its responsibilities, it appears that DHS is now well
positioned to take a lead role in promoting and coordinating the
activities of the various agencies that have technical expertise related
to environmental testing. In addition, it is important that all
participating agencies recognize and support DHS in that role and that
they have an effective structure for participating in identifying and
addressing the appropriate issues.

Recommendations for Executive Action

Given the lack of validated methods for detecting anthrax contamination in
facilities, we recommended in our 2005 report that the Secretary of
Homeland Security develop a coordinated approach to (1) improve the
overall process for detecting anthrax and (2) increase confidence in
negative test results generated by that process. This approach would
include working with agencies to ensure that appropriate validation
studies of the overall process of sampling activities, including the
methods, are conducted. Specifically, we recommended that the Secretary

           1. take a lead role in promoting and coordinating the activities
           of the various agencies that have the technical expertise related
           to environmental testing;
           2. ensure that a definition of validation is developed and agreed
           on;
           3. guarantee that the overall process of sampling activities,
           including methods, is validated so that performance
           characteristics, including limitations, are clearly understood and
           results can be correctly interpreted;
           4. see that appropriate investments are made in empirical studies
           to develop probability-based sampling strategies that take into
           account the complexities of indoor environments;
           5. ensure that appropriate, prioritized investments are made for
           all biothreat agents; and
           6. make sure that agency policies, procedures, and guidelines
           reflect the results of such efforts.

When we issued our report, CDC, DHS, and USPS agreed with our
conclusion--that methods for detecting anthrax contamination in facilities
were not validated--and with the thrust of our recommendations--calling
for a coordinated, systematic effort to validate the methods to be used
for such testing. But they (1) disagreed with or expressed concern about
our conclusions or the recommendation dealing with targeted versus
probability sampling, (2) emphasized that validated testing methods for
anthrax were not available in 2001 and that federal and state
organizations did the best they could under the circumstances, and (3)
identified factors or issues that need to be considered in validating
testing methods.

Who Is Responsible for Ensuring and Guaranteeing That Anthrax Detection Methods
Will Be Validated?

After we issued our 2005 report, it became evident that there was
uncertainty over which agency would take the lead role in improving the
overall process for detecting anthrax and how studies were to be funded.
For example, DHS stated that while it has overall responsibility for
coordinating the federal response during future biological attacks, EPA
had the "primary responsibility for establishing the strategies,
guidelines, and plans for the recovery from a biological attack" and HHS
had the lead role for any related public health response and guidelines.
DHS also stated that it coordinated regularly with EPA's National Homeland
Research Center to exchange information on research needs and to discuss
priorities and gaps for a wide range of security-related research areas.
DHS stated that it would coordinate with EPA to ensure that appropriate
investments were made to explore improved sampling. However, it is unclear
to us how DHS would ensure that appropriate prioritized investments are
made for all biothreat agents and how such priorities and gaps would be
addressed.

On the basis of these uncertainties, we recommended in our May 9, 2006,
testimony that DHS's approach to validating the overall process should
start with a strategic plan that includes a road map outlining how
individual agencies efforts would lead to the validation of the individual
activities as well as the overall process, noting that such a plan would
assist DHS in monitoring progress and measuring agency performance toward
improving the detection of anthrax and other prioritized threat agents.

On May 19, 2006, DHS officials stated that while they concurred with the
recommendations from our report and accepted the overall responsibility to
ensure the methods will be validated, they stated that "there are legal
limitations in DHS authority to direct the activities of other agencies."
They said that while they take a lead role in coordinating the meetings
and in bringing people from different agencies together, they cannot
guarantee that the overall process of sampling will be validated because
different agencies have responsibility for different aspects of
validation, and DHS's control over other agencies actions and budgets is
ultimately limited. They stated that DHS cannot ensure and guarantee that
validation studies would be done, since this is a shared responsibility
among different agencies. Also, since validation would require a sustained
effort over a long period, DHS noted that it could not mandate commitment
of other agencies' funds, over which it has no control.

DHS officials told us in July 2006 that they recognize that DHS is the
principal agency responsible for coordinating the federal response and
they would work with a good faith effort toward developing a strategy for
validation studies and a road map by the end of calendar year 2006
outlining how individual agencies' efforts would lead to the validation of
the overall sampling process. On March 27, 2007, DHS told us that it had
developed a working draft of the strategic plan and the road map by
December 2006 but it could not share these with us because they were not
final.

Until responsibility is accepted for ensuring that sampling activities
will be validated, the fate of the validation process will remain
uncertain. Without validation, if another anthrax attack were to occur
tomorrow, federal civilian agencies would not be able to conclude with any
given level of statistical confidence, in cases of negative results, that
a building is free of contamination.

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.

Contacts and Acknowledgments

For further information regarding this statement, please contact Keith
Rhodes at (202) 512-6412, or [email protected], or Sushil K. Sharma, Ph.D.,
Dr.PH, at (202) 512-3460, or [email protected]. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on the
last page of this statement. William Carrigg, Barbara Chapman, Crystal
Jones, Penny Pickett, and Elaine Vaurio made key contributions to this
statement.

(460584)

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www.gao.gov/cgi-bin/getrpt?GAO-07-687T .

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Highlights of [29]GAO-07-687T , a testimony before the Subcommittee on
Homeland Security, Committee on Appropriations, House of Representatives

March 29, 2007

ANTHRAX DETECTION

DHS Cannot Ensure That Sampling Activities Will Be Validated

In September and October 2001, contaminated letters laced with Bacillus
anthracis were sent through the mail to two U.S. senators and members of
the media. Postal facilities in New Jersey, Washington, D.C., and
elsewhere became heavily contaminated. The anthrax incidents highlighted
major gaps in civilian preparedness to detect anthrax contamination in
buildings.  GAO was asked to describe and assess federal agencies'
activities to detect anthrax in postal facilities, assess the results of
agencies' testing, and assess whether agencies' detection activities were
validated.

[30]What GAO Recommends

GAO is not making any new recommendations.

Federal agencies conducted several sampling activities, including
developing a sampling strategy and collecting, transporting, extracting,
and analyzing samples. They primarily collected samples from specific
areas, such as mail processing areas, using their judgment about where
anthrax would most likely be found--that is, targeted sampling. The
agencies did not use probability sampling, which would have allowed
agencies to determine, with some defined level of confidence, when all
results are negative, whether a building is contaminated.

The results of the agencies' testing in 286 postal facilities were largely
negative--no anthrax was detected. However, agencies did not use validated
sample collection and analytical methods. Thus, there can be little
confidence in negative results. With a validated process, agencies and the
public could be reasonably confident that any test results generated by
that process would be reliable.

The Department of Homeland Security (DHS) is the principal agency
responsible for coordinating the federal response. Thus, in its 2005
report, GAO recommended that the Secretary of Homeland Security develop a
coordinated approach to improve the overall process for detecting anthrax
and increase confidence in negative test results generated by that
process. DHS stated that while it has overall responsibility for
coordinating the federal response during future biological attacks, other
agencies have the lead responsibility for validation. Therefore,
uncertainty over which agency would take the lead role--that is, who is in
charge--in improving the overall process for detecting anthrax, including
validation of the methods, continued after GAO issued its report.

On the basis of these uncertainties, GAO recommended in its May 9, 2006,
testimony that DHS's approach to validating the overall process start with
a strategic plan that would include a road map outlining how individual
agencies' efforts would lead to the validation of the individual
activities as well as the overall process, noting that such a plan would
assist DHS in monitoring progress and measuring agency performance toward
improving the detection of anthrax and other prioritized threat agents.

While DHS generally agreed with these recommendations, it stated that it
cannot ensure validation studies would be done, since "there are legal
limitations in DHS authority to direct the activities of other agencies."
Also, since validation would require a sustained effort over a long
period, DHS noted that it could not mandate commitment of other agencies'
funds, over which it has no control.

Until responsibility is accepted for ensuring that sampling activities
will be validated, the fate of the validation process will remain
uncertain. Without validation, if another anthrax attack were to occur
tomorrow, federal civilian agencies would not be able to conclude with any
given level of statistical confidence, in cases of negative results, that
a building is free of contamination.

References

Visible links
  17. http://www.gao.gov/cgi-bin/getrpt?GAO-05-251
  18. http://www.gao.gov/cgi-bin/getrpt?GAO-05-493T
  19. http://www.gao.gov/cgi-bin/getrpt?GAO-06-756T
  20. http://www.gao.gov/cgi-bin/getrpt?GAO-05-251
  21. http://www.gao.gov/cgi-bin/getrpt?GAO-06-756T
  29. http://www.gao.gov/cgi-bin/getrpt?GAO-07-687T
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