oversight

U.S. Postal Service: Issues Associated with Anthrax Testing at the Wallingford Facility

Published by the Government Accountability Office on 2003-05-19.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                             United States General Accounting Office

GAO                          Testimony
                             Before the Subcommittee on National
                             Security, Emerging Threats, and
                             International Relations, Committee on
                             Government Reform
For Release on Delivery
Expected at 1:00 p.m., EDT
Monday, May 19, 2003         U.S. POSTAL SERVICE
                             Issues Associated with
                             Anthrax Testing at the
                             Wallingford Facility
                             Statement of

                             Keith Rhodes, Chief Technologist
                             Center for Technology and Engineering, Applied Research
                             and Methods
                             Bernard Ungar, Director
                             Physical Infrastructure Issues




GAO-03-787T
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                                                May 19, 2003


                                                U. S. POSTAL SERVICE
                                                Issues Associated with Anthrax Testing
Highlights of GAO-03-787T, a testimony          at the Wallingford Facility
before the Subcommittee on National
Security, Emerging Threats, and
international Relations, House Committee
on Government Reform




The anthrax attacks of 2001
                                                At the Wallingford facility, it took four attempts before anthrax contamination
resulted in 23 cases of the disease,
5 deaths, and the contamination of              was eventually identified. The first two attempts by U.S. Postal Service
numerous U.S. Postal Service                    contractors collected samples at various places in the facility, using dry swabs,
facilities, including the Southern              the least effective method for sample collection. The Postal Service nationwide
Connecticut Processing and                      sampling plan required that contractors use dry swabs to collect anthrax
Distribution Center in Wallingford,             samples at more than 280 facilities, including Wallingford. But the Centers for
Connecticut (the Wallingford                    Disease Control and Prevention (CDC), in commenting on the plan, had
facility). But none of the workers              recommended that the Postal Service use other sampling methods. Nevertheless,
at the Wallingford facility                     the Postal Service did not revise its sampling plan, and, with a few exceptions,
contracted the disease from the                 has not retested the other facilities that had negative test results. In the third
anthrax contamination. As a result,             attempt, CDC and the Agency for Toxic Substance and Disease Registry also
GAO was asked to examine the
                                                found no contamination using wet swabs, but in the fourth attempt------using wet
adequacy of methods used to
determine whether the Wallingford               wipes and HEPA vacuums to collect the samples------they found contamination in
facility and other postal facilities            samples from mail-sorting machines.
were contaminated. In this
testimony, GAO presents its                     Anthrax test results, whether qualitative (positive or negative) or quantitative,
preliminary findings concerning the             cannot be interpreted as a health risk, based on current scientific knowledge.
test results for the Wallingford                Positive test results establish the presence of contamination, but only in the
facility: (1) the collection of                 samples collected. Quantitative test results, although more definitive, only
samples to detect anthrax, (2) the              indicate the extent of contamination in the samples collected, not the amount
meaning of the test results, and (3)            present in the whole facility. Negative results, as the initial tests at the
the communication of the test                   Wallingford facility demonstrated, do not necessarily mean that a facility is free
results to workers.
                                                from contamination. As EPA recently reported, knowledge of the ‘‘lethal dose’’
                                                (the number of spores required to kill 50 percent of people exposed to airborne
                                                anthrax) is necessary for a credible health risk assessment. Although previous
In addition to its April 2003                   estimates of a lethal dose------8,000 to 10,000 spores------are being reconsidered,
recommendations, for those                      there is still no agreement on the lethal dose. However, some experts now agree
facilities that were deemed to be               that only a few spores could be harmful to a susceptible individual. As CDC also
free of anthrax spores based solely             concluded, even with numbers of spores as high as those found in one sample
on a single negative result, GAO                from one mail-sorting machine at Wallingford------about 3 million spores------CDC
recommends that the Postmaster
                                                did not know how to extrapolate the quantitative test results to an individual’s
General work with CDC, EPA,
OSHA, and other relevant agencies,              risk for inhalation anthrax.
and union representatives to (1)
reassess the risk level associated              In an April 2003 report, GAO found that the Postal Service’s communication of
with contamination, (2) reconsider              test results to workers at the Wallingford facility generally appears consistent
the advisability of retesting, and (3)          with its guidelines. But the decision not to release the first positive quantitative
communicate any relevant health-                test results, after a worker’s union requested them, was not consistent with
related information to postal                   OSHA’s requirement to disclose requested results. The Postal Service said it did
workers and the public.                         not release the December 2001 quantitative results because it could not validate
                                                them, as required by its guidelines, which, however, do not define validation or
                                                use it appropriately. The Postal Service communicated the results to workers as
www.gao.gov/cgi-bin/getrpt?GAO-03-787T.         ‘‘trace’’ and ‘‘a concentration of spores’’------terms that did not provide workers
                                                with useful information needed to make health-related decisions. It has agreed
To view the full product, including the scope   to revise the guidelines as GAO recommended. Further communications appear
and methodology, click on the link above.
For more information, contact Keith Rhodes,     warranted based on GAO’s ongoing work.
202-512-6412, rhodesk@gao.gov.
May 19, 2003


Mr. Chairman and Members of the Subcommittee:


We are pleased to be here today to present our findings on anthrax testing
conducted by the U.S. Postal Service (USPS) and the Centers for Disease Control
and Prevention (CDC) at the Southern Connecticut Processing and Distribution
Center in Wallingford, Connecticut (the Wallingford facility). As you know, in
September and October 2001, four letters containing anthrax spores were mailed
to news media personnel and congressional officials. As a result, the letters
contaminated numerous postal facilities and exposed several postal workers to
        1
anthrax. Some of the workers became sick, and two died of inhalation anthrax.
Three others also died from inhalation anthrax, including an elderly woman in
Connecticut------a postal customer. After contamination was found in the
Wallingford facility, a union official raised concerns regarding how postal
managers communicated test results to workers. We have issued a report in this
regard.2


Even though our analysis of the Wallingford incident is only one part of our larger
study, it gives unique insight into the lessons that need to be learned from the
response of the federal government, state health departments, and USPS to the
anthrax attacks in the fall of 2001. All of these entities served either as direct
responders or as advisors, or both; and all were creating or adapting guidelines as
the crisis progressed. The situation was further complicated by an ongoing
criminal investigation, coupled with a public health emergency.


The Wallingford facility was unique in that it did not directly handle the anthrax
letters. Rather, it was cross-contaminated by them, with the largest number of

1
  Technically, the term “anthrax” refers to the disease caused by Bacillus anthracis and not the bacterium or
its spores. In this testimony, we use the term “anthrax” for ease of reading and to reflect terminology
commonly used in the media and by the general public.




                                                     1
spores being found in a sample collected from a single machine. There was,
however, evidence that the spores had become airborne (re-aerosolized) since
small numbers of spores were found in elevated areas------more than 20 feet------above
the previously contaminated machines. In addition, while other facilities had
workers and customers who suffered from either cutaneous or inhalation anthrax,
the death of a postal customer served by the Wallingford facility underlines the
insidious nature of anthrax and the difficulty in determining a lethal dose, since
the elderly Connecticut woman died from anthrax when no evidence of anthrax
could be found in either her home or places she frequented. To compound this, a
single spore was found on a letter received by another postal customer in the
community, and yet no other illnesses or deaths were reported. Further, the
Wallingford facility was outside the predictive analysis (a mapping of the facilities
predicted most likely to be contaminated) that USPS performed to determine the
impact of the contaminated letters processed through facilities in Washington,
D.C., and Trenton, New Jersey, on the rest of the postal distribution network. The
unpredictability of both the lethality of anthrax and the route that contaminated
mail might take, makes it extremely difficult to establish the health risks
associated with a release of a biological agent inside a facility, such as anthrax,
that serves the public. This difficulty underscores the need for a standardized and
aggressive response, as well as forward planning, to protect facility workers and
the public should an anthrax attack occur again.


As you know, determining whether or not a facility is contaminated with anthrax
is critical. This is dependent upon the effectiveness of the methods used to detect
anthrax. As a result, at your request, we are conducting a study to examine the
adequacy of the methods used by involved contractors and federal agencies in
determining whether postal facilities were contaminated. We will report the final
results of this study at a later date.



2
 U.S. General Accounting Office, U.S. Postal Service: Better Guidance Is Needed to Improve
Communication Should Anthrax Contamination Occur in the Future, GAO-03-316 (Washington, D.C.:
April 7, 2003).


                                                2
In our testimony today, at your request, our remarks will focus on our preliminary
findings regarding the test results for the Wallingford facility. Specifically, we will
address the issues that arose concerning the following three areas: (1) the
collection of environmental samples to detect anthrax contamination, (2) the
meaning of the test3 results from the samples (both qualitative and quantitative)
with respect to the health risk of the workers, and (3) the communication of the
test results. Our work thus far has involved interviews with officials from USPS,
CDC, and experts in this area, reviews of relevant documents and literature, and
review of the documents we were provided by USPS and CDC associated with the
sampling done at the Wallingford facility during November 2001 through April
2002. We did not independently assess or verify any of the laboratory test results,
sampling plans, or sampling methods to determine their adequacy or accuracy.
Our work has been performed in accordance with generally accepted government
auditing standards.




SUMMARY


Three issues emerged with regard to the collection of environmental samples at
the Wallingford facility: (1) the methods used for sampling4, (2) the locations
from which samples were collected, and (3) how many samples were collected.
USPS, in response to the anthrax attack of 2001, developed a plan to test over 280
facilities nationwide, including the Wallingford facility. This plan was
precautionary and assumed that those facilities were probably not contaminated
with anthrax. Further, this plan specified what sample collection methods to use,
where to sample, and the number of samples to be collected, among other things.
At the Wallingford facility, however, it took four attempts before contamination
was eventually identified. USPS used its own contractors to collect a limited


3
 The terms “test” or “testing” refer to the laboratory analysis of the samples collected.
4
 Technically, the term “sampling” refers to a strategy to extract organisms that might be present in the
environment. In this testimony, however, sampling refers to the number of samples collected, as well as
other associated events, on a given day.


                                                     3
                                                                 5
number of samples at various places in the facility. In addition, USPS collected
the samples using the dry swab method, which is the least effective method for
collection of samples from surfaces. On November 9, CDC officials recommended
that USPS use moistened swabs; however, USPS did not incorporate this
recommendation into its sampling plan.6 According to USPS officials, in the
beginning, they mirrored the methods used by CDC in other postal facilities.
USPS did not find contamination. However, after the death of the elderly
Connecticut woman on November 21, 2001, CDC and the Agency for Toxic
Substance and Disease Registry (ATSDR) eventually used targeted sampling,
focusing on the mail-sorting machines, and different sampling methods------wet
wipes and high efficiency particulate air (HEPA) vacuum. CDC and ATSDR, using
a CDC-contracted laboratory, collected more than three times the number of
samples previously collected by USPS and found contamination in some of the
samples. Experts we consulted at the U.S. Army Medical Research Institute for
Infectious Disease told us that before October 2001, they had found that dry
swabs were ineffective at collecting spores and that spores could not be
recovered efficiently from dry swabs. Finally, even though the contamination
found at the Wallingford facility was unexpected, according to a USPS official, the
nationwide plan was not revised because it was 60-days removed from the event,
well past the perceived incubation period as far as health risk was concerned.
This approach did not take into account the possibility that if spores are present
in a facility, re-aerosolization can occur at any time if the site of contamination is
disturbed. The USPS official also said that, with a few exceptions, he believed, of
those facilities that had tested negative during the nationwide sampling, none had
been retested. Thus, the negative findings from the first three sampling attempts
at the Wallingford facility raise questions about the reliability of a single negative
sampling result, especially one based upon the use of a method considered the
least effective, as was the case in Wallingford.


5
 CDC officials told us that the number of samples collected on a given day was, in part, governed by the
capacity of the state laboratories to process the samples.




                                                    4
Neither qualitative (positive or negative) nor quantitative test results from a
qualified laboratory can be used to establish a health risk. Concerning qualitative
results, positive results only show whether contamination is present in the
samples collected. However, negative results do not necessarily mean that a
facility is free from contamination. Quantitative test results only show the extent
of contamination in the specific samples found to be positive------not how much
anthrax is present in the facility. For example, in the Wallingford facility, the level
of contamination found in a dust sample collected from a mail-sorting machine
was about 3-million spores (5.5 million per gram of dust). However, with regard
to the health risk to an individual, although this number was significantly higher
than what was considered historically to be a lethal dose for an individual------8,000
to 10,000 spores------CDC did not know how to extrapolate the amount in a sample
                                          7
to a person’s risk for inhalation anthrax. EPA recently reported that in order to
perform credible risk assessments, it is essential to identify the minimum number
of spores needed to cause inhalation and cutaneous anthrax. Nevertheless, there
is now a consensus among the experts that a few spores could be harmful to a
susceptible individual, as may have been the case in the death of the Connecticut
woman.


Three major communication issues arose at the Wallingford facility: (1) the
timing of the release of the quantitative results; (2) reasons for USPS withholding
the quantitative results from the workers, such as a lack of confirmation and
validation of the test results; and (3) the terminology used to describe the extent
of contamination to the workers. First, USPS did not communicate to the
workers the quantitative test results of the November 28, 2001, test until 9 months
after it received them, and it did not comply with the Occupational Safety and
Health Administration (OSHA) regulations, which require the release of test
results to workers after they are requested. But USPS generally communicated to

6
  USPS Draft Standard Sampling Plan dated November 9, 2001. USPS’s Draft Interim Guidelines replaced
this plan in late November 2001.
7
  It is important to note that the range of spores (8,000 to 10,000) for the human lethal dose was
extrapolated from animal studies. This range of spores refers to a dose that will kill 50 percent of




                                                 5
the workers the qualitative test results (positive and negative) soon after they
became available. Second, USPS officials told us that USPS did not release the
quantitative test results because it could not validate the confirmed results, as
required by its draft guidelines. However, these guidelines did not define either
confirmation or validation. The use of the terms ‘‘confirmation’’ and ‘‘validation’’
in this context has caused confusion both about (1) the status of the
methodologies used to detect anthrax and (2) the communication of test results to
workers. The experts we consulted told us that, in their view, the terms
confirmation and validation were not used appropriately in USPS guidelines, and
CDC concurs with this view. The guidelines do not specify the process and
methods for confirming test results. Validation is not done after a test or a
procedure has already been performed, as would have been the case with the
quantitative test result. Thus, according to the experts we consulted, validation,
when used in this sense, should not have prevented USPS from communicating
the quantitative test results. According to USPS officials, the term validation, as
used in USPS guidance, was intended to be used more for quality assurance
purposes. Finally, the terminology used by USPS after discussion with the chief
epidemiologist of the Connecticut Health Department was not helpful to workers
in assessing their risk. USPS communicated the quantitative results to workers as
‘‘trace’’ amounts and ‘‘a concentration of spores.’’ These terms did not provide
workers with useful information, when it was needed most, which was when they
were making decisions regarding their health risk. Further, the lack of
communication of the test results may have contributed to workers’ inability to
make informed decisions, such as whether to continue taking their medication or
work at another facility. As OSHA noted, ‘‘Failure to effectively communicate
issues, which can have an effect on a worker’s health and safety, can lead to fear
and mistrust.’’


Finally, USPS and the other federal agencies involved in the communication
issues we raised responded positively to the recommendations we made in our

individuals exposed to airborne anthrax. However, the lethal dose for a person could be a few spores, as



                                                     6
April 2003 report aimed at enhancing communication of test results. However,
our preliminary work on testing approaches revealed three other issues that we
believe need to be addressed. These are, for those facilities that were deemed to
be free of anthrax spores based solely on a single negative sampling result, (1) the
risk level for postal workers at those facilities and the general public served by
those facilities, (2) the advisability of retesting those facilities------employing the
most effective sampling methods and procedures, and (3) communication to
postal workers and the general public of relevant information that may be helpful
regarding their health. We are making recommendations to USPS to address
these issues.


BACKGROUND


On or about October 9, 2001, at least two letters containing anthrax spores
entered the U.S. mail------one was addressed to Senator Thomas Daschle, the other
to Senator Patrick Leahy. Before being sent to the Brentwood facility in
Washington, D.C.------the facility that processed mail to the two senators------the
letters were processed on high-speed mail-sorting machines at a postal facility in
Hamilton, New Jersey. The Hamilton facility------also known as the Trenton postal
facility------processed mail that was to be transported to the Wallingford facility for
                        8
further processing. A study conducted in Canada in 2001 has shown that a
contaminated envelope, when opened, may cause a substantial primary aerosol
event, that is, particles become airborne. Also envelopes with the open corners
not specifically sealed could also pose a threat to individuals in the mail handling
system.9


The letters to the senators contaminated the Brentwood and Hamilton postal
facilities and, according to USPS, resulted in the cross-contamination of some

may have been the case with the Connecticut woman.
8
 Two other contaminated letters were sent to a television news anchor and the editor of The New York Post
in New York City on or around September 18, 2001. Although the letters were processed through the
Hamilton (Trenton facility), it is not known whether these letters contaminated the Wallingford facility.




                                                    7
                                                                                            10
mail as it moved between these and other facilities in the postal system. Cross-
contaminated mail is believed to have been processed through the Wallingford
facility on or around October 11, 2001. The possibility of cross-contamination and
associated potential exposure to anthrax spores, contained in cross-contaminated
mail that was processed at the Wallingford facility, went unrecognized until after
the death of the Connecticut woman from inhalation anthrax on November 21,
2001. Airborne transmission of anthrax spores at the Wallingford facility and
other facilities is believed to have been facilitated by the use of high-speed
sorters, as well as compressed air, for routine cleaning of the mail-sorting
         11
machines. As a result, USPS terminated the use of compressed air at all postal
facilities on October 23, 2001.


Environmental testing and remediation for anthrax contamination in a facility
consists of several steps: sample collection, laboratory identification,
decontamination, and retesting. To collect samples, a sampling plan should be
developed, which specifies, among other things, number of samples, specific
methods to collect the samples, areas in which to sample, and instructions for
submitting the samples to a qualified laboratory for analysis. A variety of sample
collection methods were used in the Wallingford facility, including dry swabs, wet
wipes, and HEPA vacuums. Swabs------either wet or dry------have small surface areas
(similar to Q-tips®). They are typically used to sample small, nonporous surface
areas (less than 100 sq. cm) that do not have a large accumulation of dust. Wet
wipes--sterile gauze pads, approximately 3 inches square--are typically used for
sampling larger (more than 100 sq. cm), nonporous surface areas. HEPA vacuum
is a suction device with a nozzle------including a cone-shaped filtering trap or sock
attached------to collect dust samples from a surface or the air. After samples have
been collected, they are to be transported to a qualified laboratory for analyses.

9
  B. Kournikakis, and others, Risk Assessment of Anthrax Threat Letters. Suffield: DRES Technical Report
TR 2001-048, September 2001.
10
   USPS officials suspect that the source of the contamination that caused the elderly woman to contract
anthrax was the October 9th set of letters processed at the Hamilton facility in New Jersey.
11
   Centers for Disease Control and Prevention, “Evaluation of Bacillus anthracis Contamination Inside the
Brentwood Mail Processing and Distribution Center—District of Columbia; Mortality and Morbidity
Weekly Report (2001), vol. 50, pp. 1129-1133.


                                                    8
A range of laboratory tests exists for detecting anthrax in a person’s body and in
the environment. However, analysis by the culture method is considered to be the
gold standard for identifying anthrax. Qualified laboratories report anthrax test
results either qualitatively (for example, as ‘‘positive’’ or ‘‘negative’’) or
quantitatively (for example, as a specific number of colony-forming units (CFU)),
12
     that is, living cells per gram or square inch of material sampled or in milligrams
per micro liter.


USPS’ SAMPLING APPROACH DID NOT IDENTIFY ANTHRAX AT THE
WALLINGFORD FACILITY


USPS’s initial sampling approach at the Wallingford facility was ineffective in that
it did not detect contamination at the Wallingford facility as soon as was
practically possible. If additional testing had not been done to determine the
source of contamination for the death of the Connecticut woman from inhalation
anthrax, it is possible that the contamination would have gone undetected. USPS
guidelines specified the least effective method for sample collection. Assuming
that there was probably no anthrax contamination, USPS, as part of its nationwide
testing of over 280 facilities, initially used a precautionary approach to determine
                                                                                                       13
whether those facilities, including the Wallingford facility, were contaminated.
This approach included a method------dry swabs--considered to be the least effective
for sample collection, based on comparative studies and the opinions of experts
we consulted. This approach did not find contamination (negative results) in the
Wallingford facility. On the other hand, CDC used an approach at the Wallingford
facility that included a combination of more effective methods------wet wipes and
HEPA vacuum------with which contamination was found. Further, USPS officials
told us that based on their mail-tracking system, they identified some postal

12
  The term “colony-forming units” refers to the number of living cells in a sample and is typically reported
per gram of material sampled for HEPA vacuum samples and per square inch for samples collected using
wipes.
13
  Facilities in Florida, New Jersey, New York, and Washington, D.C., had already been tested and found
contaminated.


                                                     9
facilities that they considered likely to have been contaminated by anthrax letters
processed through those facilities.14 However, Wallingford was not one of these.
The negative test results for the sampling at the Wallingford facility must,
therefore, cast doubt about the true extent of contamination in other facilities that
tested ‘‘negative.’’


As part of its approach, USPS used its draft Standard Sampling Plan, which
specified a minimum number of samples to be collected from various areas, using
the dry swab method.15 USPS used four contractors to sample the Wallingford
facility. These contractors were previously contracted to conduct routine
environmental sampling for such substances as air and water, rather than dealing
with unusual and dangerous bacteria such as anthrax. Before the Wallingford
facility was tested, USPS and CDC had learned that some of the mail-sorting
machines in the facilities that processed the letters containing the anthrax
powder------for example, the Brentwood and Trenton facilities------were found to be
heavily contaminated. This suggests that mail-sorting machines would be a likely
starting point for sample collection.


On November 11, 2001, using a contractor, USPS collected 53 samples from
various sites throughout the facility using dry swabs. The test results were
negative. Although USPS, as part of its nationwide sampling, had only intended to
test the facility once, it retested the facility on November 21, the day that the
elderly Connecticut woman died, to determine the possible source of
contamination. On November 21, USPS attempted to identify the path the
contaminated letter would have taken. USPS collected 64 samples from surfaces
where mail was processed and from air-circulating units, using dry swabs. Again
the test results were negative. The November 25, 2001, testing by CDC and the

14
   According to USPS, to determine the condition of sites of possible contamination and to evaluate specific
downstream sites throughout the country, USPS obtained test equipment, systems, and contract services.
When testing was completed in late November 2001, 284 facilities were tested, with 23 positive and 261
negative results.
15
   USPS contractors used the USPS Draft Standard Sampling Plan, dated November 2 and 9, 2001. The
draft USPS interim guidelines, dated November 16, 2001, replaced this plan, and a subsequent version of
the guidelines was issued December 4, 2001.


                                                    10
ATSDR, while using a different method------wet swab------also collected 60 samples, of
which 8 were from mail-sorting machines. Again, the results were negative. Of the
177 samples collected during the November 11, 21, and 25 samplings, 15 samples
were collected from the facility’s 13 mail-sorting machines. The Connecticut
Public Health Laboratory analyzed all of these samples. In addition, according to
CDC officials, the numbers of samples collected on the above dates were, in part,
influenced by the capacity of the Connecticut Public Health Laboratory. (See
table 1 for sampling details.)


Table 1: Summary of Sampling for Anthrax Contamination between November 2001 and April 2002
and the Associated Test Results for the Wallingford Facility



                           No. of samples                      Test results
                           (Samples
                           collected from       Qualitative                                     Agency
Sampling Method            mail-sorting         (No. positive)   Quantitative                   collecting
                                                                                                         a
date        used           machines)                                                            samples
Five tests performed during initial period of contamination
11/11/01    Dry swabs     53 (1)                Negative         N/A                            USPS
11/21/01    Dry swabs     64 (6)                Negative         N/A                            USPS
11/25/01    Wet swabs     60 (8)                Negative         N/A                            CDC
                                                                                        b
11/28/91    Wet wipes      212 (130)            Positive (6)     3 million CFU/0.55 gram        CDC
            and HEPA
            vacuums                                              370 CFU/gram
12/2/01     Wet wipes     200 (200)             Positive (35)    N/A                            CDC
                                                   c
Test (precautionary) performed in high-bay areas
4/21/02     HEPA           101 (N/A)            Positive (3)     1 colony from 7.50 gram        USPS
            vacuums                                              sample material

                                                                     10/11 colonies from 7.69
                                                                     gram sample material

                                                                     13/18 colonies from 5.67
                                                                     gm sample material
Source: GAO (summary), USPS, and CDC (data).
a
  The USPS used a contractor; CDC was assisted by the Agency for Toxic Substances and Disease
Registry.
b
 The sample collected contained 0.55 gram of material (dust) from the heavily contaminated machine. The
laboratory adjusted its analyses to reflect a full gram of sample material and reported the presence of 5.5
million CFUs per gram, which the chief epidemiologist subsequently determined, through extrapolation, to be
2.9 million CFUs—or about 3 million spores— in the sample. In this testimony, we refer to the 2.9 CFU for
the 0.55 grams of sample material actually collected.
c“
 High-bay” areas refer to elevated areas in the facility such as pipes, ducts, joists, beams, and overhead
conveyors. Precautionary testing was performed to ensure no anthrax was present during annual cleaning.

Note: N/A = Quantitative data either not applicable (no anthrax present) or not provided.




                                                     11
On November 28, CDC and ATSDR performed what they termed ‘‘targeted’’
testing, based upon new information concerning which mail-sorting machines
were likely to have processed the woman’s mail. CDC and ATSDR collected 212
samples using a combination of methods: wet wipes and HEPA vacuums, rather
than the wet swabs CDC had previously used. This time, CDC and ATSDR
collected 130 samples from the mail-sorting machines as opposed to the 15
samples collected during the three prior sampling efforts. A CDC-contracted
laboratory analyzed the samples and found 6 that were positive for anthrax, 2 of
which had been collected by HEPA vacuum and four by wet wipes. For the
November 28 samples, the laboratory also provided two quantitative results, one
of which, according to the Connecticut chief epidemiologist, was about 3 million
CFUs of anthrax (that is, 5.5 million CFUs per gram of dust) in a sample collected
from a heavily contaminated mail-sorting machine.


Finally, on December 2, while the contaminated machines were isolated and the
process of decontamination was beginning, CDC and ATSDR used wet wipes
alone to collect 200 follow-up samples from the machines to determine the extent
of contamination on the machines and found 35 additional positive samples. On
April 21, 2002, a USPS contractor, in consultation with CDC, OSHA, EPA, and the
Connecticut Department of Public Health------using HEPA vacuums------tested
elevated, or high bay, areas above the previously contaminated machines. The
sampling was performed because of a USPS requirement for testing prior to the
routine cleaning of elevated areas in facilities that had previously tested positive
for anthrax. The effort was undertaken to protect workers from the possibility of
exposure to spores that may have blown into these areas as a result of USPS’s
prior use of compressed air to clean its facilities. The results revealed from 1 to 18
CFUs in 3 of 101 samples collected from the elevated areas.16 This finding
indicates that spores had been airborne at some period in the facility.


16
  Specifically, the test results indicated (1) 1 CFU from 7.50 grams of material sampled, (2) 10 CFU and
11 CFU from 7.69 grams of material sampled, and (3) 13 CFU and 18 CFU from 5.67 grams of material
sampled.


                                                    12
Based on the testing done at the Wallingford facility by USPS and by CDC and
ATSDR, neither dry nor wet swabs alone identified anthrax contamination in the
samples collected. Wet wipes and HEPA vacuums did identify anthrax in some
samples. Experts we consulted at the U.S. Army Medical Research Institute for
Infectious Disease told us that before October 2001, they had found that dry
swabs were ineffective at collecting spores. CDC, on November 9, 2001, in
commenting on USPS draft guidelines, recommended that USPS use sterile swab
samples for environmental sampling and that these swabs be moistened with
sterile water. In addition, CDC informed USPS that CDC’s own draft procedures,
that is, ‘‘Procedures for Collecting Environmental Sampling for Culturing Bacillus
anthracis,’’ continued to address bulk and vacuum samples. CDC draft guidelines
did not, however, address the use of wet wipes. CDC also stated that, ‘‘some of the
state labs may be less familiar with the methods needed to perform analyses for
vacuum and bulk samples.’’ Finally, CDC stated that it understood that USPS’ sole
use of the swab method was related to an accommodation reached with the
Association of Public Health Laboratories to more effectively use state health
department laboratories to assist with sample analysis. USPS also acknowledged
in a subsequent draft of its guidelines that, ‘‘the Association of Public Health
Laboratories does not recognize air, bulk, or HEPA vacuum for purposes for
Bacillus anthracis identification.’’


USPS officials we interviewed said that in the beginning, USPS mirrored the
methods used by CDC in the Brentwood and Trenton facilities. The officials noted
that, at one point, ‘‘one method was recommended, and later, another method was
recommended.’’ USPS officials also told us that in the absence of any other
guidance, they were attempting to use pre-existing guidance and extrapolate it to
a bio-terrorist attack. In December 2001, a study carried out by CDC, ATSDR, and
USPS clearly showed that sampling methods differed significantly in their ability




                                          13
                                                                           17
to detect spores, even in a heavily contaminated facility.                      According to the study,
dry swabs failed to detect spores more than 86 percent of the time, wet swabs
more than 46 percent, HEPA more than 20 percent, and wipes more than 13
percent. Based on the study, CDC concluded that dry swabs should not be used
to sample for anthrax. Finally, a report by the EPA, dated February 2003, on
environmental sampling for anthrax spores at USPS Morgan Postal and
Processing facility stated that wipe samples should be used for sampling large
surface areas, and wet techniques are more effective than dry techniques. The
report stated that epidemiological approaches for different scenarios of
                                           18
environmental sampling should be developed. These issues raise questions about
the reliability of a single ‘‘negative’’ sampling result, especially based on the least
effective method------dry swabs------as was the case initially in Wallingford.19


TEST RESULTS CANNOT BE USED TO DETERMINE HEALTH RISK FOR
WORKERS


Neither qualitative (negative or positive) nor quantitative tests results can be used
to definitively establish the risk to an individual’s health. Interpreting positive test
results from a sample as a health risk would require a real understanding of the
physical behavior of airborne anthrax spores as well as factors that may influence
their behavior. Thus, while both qualitative and quantitative test results from a
qualified laboratory can show that a facility is contaminated, they do not show the
actual extent of contamination in the facility or the health risk for workers. In
particular, qualitative test results show if a facility is contaminated or not.
Further, while quantitative test results show the number of CFUs in a sample,
such results can be difficult to interpret and, possibly misleading, depending upon
the relative distribution of surface dust versus spores and the effectiveness of the

17
   See CDC, “Surface Sampling Methods for Bacillus anthracis Spore Contamination,” Emerging
Infectious Diseases Journal, Vol. 8, No. 10 (October 2002).
18
   U.S. Environmental Protection Agency: Summary Report: Peer Review Workshop on Environmental
Sampling for Anthrax Spores at Morgan Postal Processing and Distribution Center, May 30, 2002, New
York City, New York. (EPA 500-R-03-001, Washington, D.C., February 2003).
19
   USPS officials told us that they are in the process of revising their interim guidelines, however, we have
not yet reviewed these revised guidelines.


                                                     14
sampling methods. Nevertheless, because of factors affecting how well a sample
method picks up anthrax and limitations affecting the amount of anthrax that can
be extracted from that sample, experts agree that there would be more anthrax in
the facility than can be picked up by a sample. However, according to officials
from the U.S. Army Medical Research Institute for Infectious Disease, what is
most important is not the number of spores in a sample but whether or not any
spores exist. On the other hand, EPA recently reported that in order to perform
credible risk assessments, it is essential to identify the minimum number of
spores needed to cause inhalation and cutaneous anthrax.


Negative test results, as shown at the Wallingford facility, do not necessarily mean
that a facility is free from contamination. Test results at a contaminated facility
could be negative if (1) the sampling method used was not sufficiently effective;
(2) samples were not collected from places where contamination was actually
present; and (3) an insufficient number of samples were collected. Concerning
the sampling methods used in the Wallingford facility, for example, the samplings
conducted on 3 different days, which involved collecting a limited number of
samples from various places in the facility, using either dry or wet swabs, came
out negative, while a subsequent sampling------which used (1) a combination of
sampling methods, (2) a different sampling approach, and (3) an increased
number of samples------came out positive. It is, therefore, essential to have a sound
sampling plan that includes effective methods and do repeat testing if it is
considered necessary.


Once contamination is confirmed, actions must be taken to protect the workers
and decontaminate the facility. Interpretation of the positive test results requires a
real understanding of the physical processes involved in generating airborne
particles, such as anthrax; the behavior of such particles; and the factors that
influence their behavior. Evaluation of the health risks involves the assessment of
components that govern the particle-size profile, stability, and biological impact.
The greatest risk to a worker’s health in the Wallingford facility appears to have



                                          15
come from the particles that became airborne as mail that had been cross-
contaminated passed through the sorting machines. In the case of the Wallingford
facility, postal officials suspect that contamination of the facility may have
occurred a few days after October 9, when the second set of letters, those
addressed to the two senators, passed through the Trenton facility. It is likely that
this high-risk period would have been no more than a few hours, while spores
were still airborne. Nevertheless, once spores have settled, a risk can arise if
spores again become airborne, thus making it possible for workers to inhale them.


Investigations of anthrax contamination in the U.S. Senate Office building found
that simulated day-to-day office activities (that is, paper handling, foot traffic, mail
sorting, trash container movement, patting chairs) resulted in spores again
becoming airborne. Eighty percent of these airborne particles were in the size
range 0.9 to 3.5 microns and, thus, would be capable of causing inhalation
        20
anthrax. It was noted that even minimal movement caused viable spores to
become airborne. It is therefore very likely that compressed air, used for machine
cleaning, could provide sufficient energy to cause particles to become airborne,
particularly from areas where there are high local concentrations of spores, as
was the case in Wallingford. Similarly, the processing of a cross-contaminated
letter through a sorting machine may also provide sufficient energy to cause
spores to again become airborne. Based on these findings, it is important to
recognize that in a mail-processing facility that has tested positive for anthrax,
there is a risk to the health of workers because spores may become airborne again
after the primary event------the passage of the contaminated letters------has occurred.
In addition, these spores could then create a risk of cross-contamination of mail.


USPS asked CDC whether it should conduct additional testing of postal facilities
to assure workers safety. On February 25, 2002, in its response, CDC stated that
additional testing was not warranted at that time. CDC noted several reasons for
not retesting those facilities including, (1) qualitative or quantitative testing for




                                           16
anthrax does not accurately correlate with exposure threshold or predictors of
disease at these work sites; (2) since the initial contamination, there has been no
report indicating increased risk for disease among the workers at these sites; and
(3) there is a good reason to believe that the risk for workers has decreased since
the initial attack as a result of USPS’s newly adopted prevention and control
measures, such as repetitive machine decontamination, medical monitoring, and
revised operating and maintenance procedures.


According to the experts, the level of contamination found at the Wallingford
facility was significantly higher than the level------8,000 to 10,000 spores------
historically considered likely to cause disease in the individual when inhaled in a
fine powder form. However, there is now a consensus among the experts that
even a few spores could be harmful to a susceptible individual, as may have been
the case in the death of the Connecticut woman. According to officials from the
U.S. Army Medical Research Institute of Infectious Disease, what is most
important is not the number of spores in a facility but whether or not any spores
are found.


In an attempt to lessen the risk that spores might become airborne, USPS stopped
the use of compressed air for cleaning mail-sorting machines and also revised its
cleaning methods to include those less likely to cause spores to be blown about
the facility, for example, wet mopping instead of dry brushing.


USPS’S FAILURE TO RELEASE QUANTITATIVE RESULTS CAUSED
COMMUNICATION PROBLEMS AT THE WALLINGFORD FACILITY


USPS generally provided the Wallingford facility’s test results to workers at the
facility within 1 day of receiving the results, consistent with USPS guidelines
requiring that workers be notified ‘‘as soon as possible.’’ However, USPS did not
inform the workers as promptly after contamination was identified in the facility

20
     C.P. Weiss and others, “Secondary Aerosolization of Viable Bacillus anthracis Spores in a Contaminated



                                                     17
in December 2001, and it also did not promptly provide information to workers on
the quantitative test results after a union official requested them.


On December 2, 2001------when anthrax contamination was first identified in the
facility------USPS met with workers to inform them that ‘‘trace’’ amounts of anthrax
had been found in samples collected on November 28. Knowing that the
laboratory initially identified a small number (one or two CFUs) of anthrax
spores, the chief epidemiologist for Connecticut------who helped lead the
investigation------told district postal managers that it would be accurate to use the
term ‘‘trace’’ to describe the extent of contamination. On December 12, 2001------2
days after district postal managers said they received written confirmation of the
presence of about 3 million spores in one of the samples collected on November
28 and, possibly, 4 days after headquarters postal managers received the results------
district postal managers told us that they informed workers of the following:
While trace amounts of anthrax existed on three mail-sorting machines, a
‘‘concentration’’ of spores had been identified in a sample collected from a fourth
machine. But it was not until 9 months after USPS had received the quantitative
results of the November 28, 2001, testing that it provided the information to the
workers.


According to USPS, it did not release the quantitative test results to workers
because it could not validate the confirmed results, as required by its guidelines,
which state that results cannot be released until confirmed data are received from
CDC or a state public health laboratory. However, the guidelines do not define
the meaning of either ‘‘confirmation’’ or ‘‘validation,’’ nor do they specify the steps
that must be taken to validate test results. According to USPS managers, USPS
could not ensure that the sampling had been done in accordance with procedures
specified in the guidelines and, thus, could not validate the results, as required by
                   21
the guidelines.         A USPS headquarters’ manager told us that the term validation


U.S. Senate Office,” Journal of American Medical Association, vol. 288 (2002), pp. 2853-2858.
21
  U.S. Postal Service, Interim Guidelines for Sampling, Analysis, Decontamination, and Disposal of
Anthrax for U.S. Postal Service Facilities (Dec. 4, 2001). These guidelines were developed as the anthrax


                                                    18
was intended to describe a method for ensuring that work had been done in
accordance with USPS’ sampling and testing procedures and for coordinating the
release of validated results. A USPS official also told us that the term validation,
as used in USPS guidance, was intended to be used more for quality assurance
purposes. The guidelines do not specify who is to do the validation or how it is to
be done, particularly when the testing is not done or sponsored by USPS. Thus,
the use of the terms confirmation and validation in the context of USPS guidelines
has caused confusion about (1) the status of the methods used to detect anthrax
(e.g., were the methods appropriately used) and (2) whether and when test results
were to be communicated to workers.


The experts we consulted told us that, in their view, the terms confirmation and
validation were not used appropriately in USPS guidelines. Confirmation is a
process in which a qualified laboratory, using specific tests, determines the
presence of anthrax in a sample. Normally, validation is a process that is carried
out before a test or procedure is used for a specific purpose to ensure that such a
test or procedure is effective. Thus, according to these experts, validation is not
usually done after a test or a procedure has already been performed, as would
have been the case had the results been validated in the manner described by
USPS officials. Thus, according to the experts we consulted, validation, when
done appropriately, should not have prevented USPS from communicating the
quantitative test result.


These experts also (1) told us that the sampling method (HEPA vacuums) used to
collect the samples that were quantified was appropriate and (2) agreed that the
lack of documentation about the extent of surface area sampled, especially given
the complexity of the facility’s mail-sorting machines, could have made
                                         22
interpretations of the results difficult. They explained that the method of

crisis unfolded, with input and guidance from several federal agencies, including CDC and OSHA, and the
national unions that represent postal workers.
22
  We consulted with numerous experts in the field of microbiology, including Dr. Jack Melling, former
Director and Chief Executive Officer of the British Center for Applied Microbiology Research, Porton
Down; Dr. Paul Keim, Professor in Microbiology, Northern Arizona University; Col. Eric Henchal,


                                                  19
counting CFUs is a long-standing, definitive, and universally accepted
microbiological technique for determining the amount of bacteria in a given
sample, including anthrax. The results show how many spores have replicated to
form colonies, which can then be seen by the naked eye. Thus, regardless of the
sampling issues at Wallingford, none of the agencies involved provided any
evidence indicating that the number of CFUs identified by the laboratory was
incorrect.


USPS communicated the quantitative results to workers as ‘‘trace’’ amounts and ‘‘a
concentration of spores,’’ based on discussions with the chief epidemiologist of
the Connecticut Health Department. However, according to the experts we
consulted, use of the terms trace amounts or concentration of spores did not
provide workers with useful information, when it was needed most, which was
when they were making decisions regarding their health risk.


According to experts we consulted, the use of the term ‘‘concentration’’ to convey
the finding of about 3 million spores in one sample may have been misleading
because it did not adequately convey the potential health risk associated with the
sample, along with any limitation associated with the results. The experts also
said that providing information about the actual test results to workers would
have given them better information for making informed medical decisions. In
this case, according to the experts we consulted, an appropriate way to
communicate the results to workers would have been to indicate that 2.9 million
CFUs (from 0.55 grams of dust) were found in a sample from one machine, along
with appropriate limitations regarding the sampling procedures used.


Following a request for test results by a union leader and an investigation by
OSHA, USPS eventually released the quantitative results 9 months later. The delay
was not consistent with OSHA regulations. OSHA did not cite USPS for failure to
disclose the quantitative test results within 15 working days of the union leader’s

Department of the Army; and Dr. Barbara Johnson, former Safety Officer at the Dugway Proving Grounds,



                                                 20
January and February 2002 requests; however, in an October 7, 2002, letter to
USPS, OSHA noted that a ‘‘failure to effectively communicate issues which can
have an effect on a worker’s health and safety, can lead to fear and mistrust.’’


In addition, two federal guidelines, developed in 2002 by GSA and the National
Response Team, suggest that more------rather than less------information should be
disclosed. For example, GSA’s guidelines emphasize the need for ‘‘timely, clear,
consistent, and factual’’ information, including any limitations associated with the
information, so that people can make informed decisions. The other set of
guidelines, developed by the National Response Team, warns agencies not to
withhold information because it could affect the agency’s credibility. However,
neither USPS’s guidance nor the more recent federal guidelines fully address the
communication-related issues concerning anthrax that developed at the
Wallingford facility. For example, none of the guidelines specifically require the
full disclosure of all test results, including quantitative test results. Likewise,
OSHA regulations for communicating test results to workers do not address the
need for full, immediate, and proactive disclosure. Thus, we made several
recommendations to minimize the likelihood that the communication-related
problems at the Wallingford facility will recur elsewhere (see appendix I). USPS,
EPA, and GSA generally agreed with our recommendations affecting them, but
OSHA did not comment on our recommendation to it.


Our work to date on this study has revealed three other issues that we believe
need to be addressed. These are, for those facilities that were deemed to free of
anthrax spores based solely on a single negative sampling result, (1) reassessing
the risk level for postal workers at those facilities and the general public served
by those facilities, (2) reconsidering the advisability of retesting those facilities------
employing the most effective sampling methods and procedures, and (3)
communicating to the postal workers and the general public the results of the
reassessment of health risk, the advisability of retesting, the rationale for these


Department of the Army.


                                             21
decisions, and other relevant information that may be helpful regarding the health
of the postal workers and the general public.




CONCLUSIONS


The Wallingford incident gives unique insight into the lessons that need to be
learned from the response of the federal government, state health departments,
and USPS to the anthrax attacks in the fall of 2001. The unpredictability of the
lethality of anthrax; the broad spectrum of the population at risk of exposure,
including postal workers, postal customers and others; and the inability to
determine the route that contaminated mail might take as well as the extent of
cross-contamination, are all factors that make it extremely difficult to establish
the health risks associated with a release of a biological agent, such as anthrax,
inside a facility that serves the public. This difficulty underscores the need for a
standardized and aggressive response as well as forward planning to protect both
the workers and the public should this happen again.


When considering the testing approach taken, and the methods used, to detect
anthrax in postal facilities in the fall of 2001, it is important to recognize that the
knowledge and experience of public health officials and others in this area were
continually evolving. Experts we consulted and studies we reviewed indicated
that the use of dry swabs alone were the least effective method of detecting
anthrax. In addition, CDC recommended that dry swabs should not be used for
anthrax detection. Initial sampling of the Wallingford facility, using USPS
nationwide sampling guidelines (which provided for the use of dry swabs), did not
find contamination. Also, use of the same guidelines to conduct nationwide
testing may not have identified anthrax contamination that could have existed in
some of those facilities that tested negative using dry swabs alone.




                                           22
In February 2002, CDC advised USPS, that to ensure worker safety, there was no
need to retest postal facilities for a variety of reasons. Accordingly, USPS
followed CDC’s advice and did not retest any of those facilities. However, in our
discussion with CDC officials, they agreed that there are many uncertainties
associated with anthrax risk assessment. For example, we do not know the lethal
dose for an individual, how to extrapolate contamination in a facility to a health
risk for an individual, and whether postal facilities still contain spores, and the
reliability of the methods used to rule out anthrax contamination. CDC also
agreed that there could still be spores in some facilities. Consequently, there
remains a risk, albeit probably low, of further infection. While CDC judges the
risk to be low, we believe that it is important that this judgment of the risk be
communicated to workers and the general public so that they are in a position to
make informed decisions about their health and safety.


Public health response is most effective and efficient when it is proactive, when it
focuses on prevention, rather than on consequent management. Thus, the
Wallingford incident illustrates the challenges facing the federal government, the
state health departments, the network of diagnostic laboratories and those
companies that serve the general public, including USPS. The challenge can be
summed up in one question, "Is it safe?" This is what everyone asked during the
fall of 2001, and this is what everyone is trying to answer to this day.
Unfortunately, the best answer anyone can give is, "It is probably safe." Once a
building has been contaminated, one can never say there is no risk, but there can
be a low risk. What all those who are trying to protect the public health must
realize is that they are defining the risk level for others: in this case, the postal
workers as well as the general public.



RECOMMENDATIONS




                                           23
The impact of additional anthrax cases could result in illness or loss of life as well
as loss of confidence in the nation’s postal system. Further, even though the
health risk is probably low, it is uncertain; we therefore recommend that the
Postmaster General, in consultation with CDC, EPA, OSHA, as well as any other
relevant agencies and postal unions, for those facilities that were deemed to free
of anthrax spores based solely on a single negative sampling result, (1) reassess
the risk level for postal workers at those facilities and the general public served
by those facilities, (2) reconsider the advisability of retesting those facilities and
employing the most effective sampling methods and procedures, and (3)
communicate to the postal workers and the general public the results of the
reassessment of health risk, the advisability of retesting, the rationale for these
decisions, and other relevant information that may be helpful regarding the health
of the postal workers and the general public.


Mr. Chairman, this concludes our statement. We will be happy to answer any
questions you or members of the Subcommittee may have.


CONTACTS AND ACKNOWLEDGMENTS


Should you or your offices have any questions concerning this report, please
contact me at (202) 512-6412 or Bernie Ungar at (202) 512-2834. We can also be
reached by e-mail at rhodesk@gao.gov and ungarb@gao.gov. Individuals making
key contributors to this testimony were Don Allison, Hazel Bailey, Latesha Love,
Laurel Rabin, Cady Summers, and Kathleen Turner. Drs. Jack Melling and Sushil
Sharma provided technical expertise.




                                           24
Appendix I


RECOMMENDATIONS CONTAINED IN OUR APRIL 2003 REPORT ON THE
WALLINGFORD FACILITY


To help prevent the recurrence of the communication problems that occurred at
the Wallingford facility, we recommended that the Postmaster General; the
Administrator of the General Services Administration; and the Administrator of
the Environmental Protection Agency, as Chairperson of the National Response
Team, work together to, where applicable, revise guidelines to


   •   require prompt communication of test results, including quantified results
       when available, to workers and others;
   •   specify the terminology that should be used to communicate quantitative
       test results to workers and others (e.g., the number of colony-forming units
       per gram or square inch of material sampled) and any limitations
       associated with the test results;
   •   define what is meant by the validation of test results and explain the steps
       that must be taken to validate sampling or testing methods that are
       undertaken by the agency itself or by another organization;
   •   specify the actions that should be taken if test results cannot be validated,
       including a strategy for communicating unvalidated results;
   •   specify the agencies that should be involved in deciding what to
       communicate to workers and others, as appropriate;
   •   require documentation of the basis for decisions made, including the (1)
       advice the organization receives from public health officials and others
       about the communication of health-related information to workers and
       others, as appropriate, and (2) specific content of what agencies and other
       organizations communicate to workers and others; and
   •   reflect the Occupational Safety and Health Administration’s regulations for
       disclosing test results requested by workers or their designated



                                           25
       representatives.


In light of new concerns about the possibility and impact of future terrorist
actions using unforeseen hazardous substances, we also recommend that the
Assistant Secretary for Occupational Safety and Health consider whether the
Occupational and Health Administration regulations should require------in
emergency situations------full and immediate disclosure of test results to workers,
regardless of whether the information is requested by a worker or his or her
designated representative.




(460533)



                                         26
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