OFFICE OF INSPECTOR GENERAL
Evaluation Report
       EPA Needs to Fulfill Its
       Designated Responsibilities to
       Ensure Effective BioWatch
       Program
       Report No. 2005-P-00012

       March 23, 2005

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Report Contributors:                   Anne Emory
                                      Fredrick Light
Abbreviations
CDC         Centers for Disease Control and Prevention
DFU         Dry Filter Unit
DHS         Department of Homeland Security
DOD         Department of Defense
DOE         Department of Energy
EPA         Environmental Protection Agency
FBI          Federal Bureau of Investigation
GAO         Government Accountability Office
OIG         Office of Inspector General
PCR         Polymerase Chain Reaction
PSU         Portable Sampling Unit
Cover photos:   From left: a BioWatch monitor (courtesy Environmental Protection Agency);
                a map demonstrating a hypothetical biological agent plume (courtesy Houston
                Department of Health and Human Services); and a gas mask worn during a
                demonstration (courtesy Department of Homeland Security).

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U.S. Environmental Protection Agency
Office of Inspector General

At  a  Glance
 2005-P-00012
March 23,2005
               EPA Needs to Fulfill Its Designated Responsibilities
               to Ensure Effective BioWatch Program
                What We Found
               The Department of Homeland Security (DHS) funds and oversees the
               BioWatch program while relying on the assistance and expertise of EPA and
               other agencies. DHS uses EPA to award and manage cooperative agreements
               to State and local air monitoring agencies to collect filter samples.

               EPA's designated responsibilities include a crucial part of the BioWatch
               program - the sampling operations.  These operations include monitor
               deployment, site security, oversight, and assessing monitor technology.
               However, we found that EPA did not provide adequate oversight of the
               sampling operations to ensure quality assurance guidance was adhered to,
               potentially affecting the quality of the samples taken. EPA completed a
               technology assessment of the existing BioWatch monitors, but also needs to
               be involved in assessing technologies mat are more reliable and timely, and
               reduce costs. A lack of consequence management planning was highlighted
               when a biological agent was detected in Houston in 2003. After this incident,
               EPA collaborated with DHS and the Centers for Disease Control and
               Prevention on the development of consequence management plan guidance,
               but at the time of our review State and local consequence management
               planning was incomplete.
                What We Recommend
               EPA's Assistant Administrator for Air and Radiation should ensure that EPA
               fulfills all of the BioWatch-destgnated responsibilities, including ensuring
               quality assurance guidance is adhered to. Further, although not a
               responsibility  specifically designated to EPA as part of the BioWatch
               program, we suggest that the Assistant Administrator for Air and Radiation
               have EPA work closely with the BioWatch partners to:

               • use its air monitoring experience to assist DHS in identifying and testing
                 alternative technologies that are more reliable, timely, and efficient for
                 detecting biological agents; and
               • ensure the Agency is adequately prepared to assist with consequence
                 management plans in the event of a biological agent release.

               The Agency agreed with  our report and stated it has begun working with EPA
               regions to address many of the issues that we identified.

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                     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                   WASHINGTON, D.C. 20460
                                                                          OFFICE OF
                                                                       INSPECTOR GENERAL
                                   March 23,2005

MEMORANDUM

SUBJECT:        EPA Needs to Fulfill Its Designated Responsibilities to Ensure
                  Effective BioWatch Program
                  Report No. 2005-P-00012

FROM:           Jeffrey K. Harris /s/
                  Director for Program Evaluation, Cross-Media Issues

TO:               Jeffrey R. Holmstead
                  Assistant Administrator, Office of Air and Radiation

This is the final report on our evaluation of the Environmental Protection Agency's (EPA's) role
in the BioWatch program. The report contains findings that describe problems we identified and
corrective actions we recommend. This report represents the opinion of the Office of Inspector
General (OIG) and the findings in this report do not necessarily represent the final EPA position.
Final determinations on matters in the report will be made by EPA managers in accordance with
established procedures.

Our final report acknowledges and includes your February 8,2005, response to our draft report.
We commend the Office of Air and Radiation for taking actions to address the concerns of the
report, as well as the actions planned.  We included EPA's response in Appendix C. We also
met with Department of Homeland Security (DHS) officials on March 8,2005, based on EPA's
concern about releasing sensitive information. DHS officials stated  that our report does not
release any sensitive information.

Action Required

In accordance with EPA Directive 2750, as the action official, you are required to provide this
Office with a written response within 90 days of the final report date. The response should
address all recommendations. For the corrective actions planned but not completed by the
response date, please describe the actions that are ongoing and provide a timetable for
completion.  We appreciate the efforts of EPA officials and staff in working with us to develop
this report. For your convenience, this  report will be available at http://www. epa.gov/oig.

If you or your staff have any  questions  regarding this report, please contact me at (202) 566-0831
or Fredrick Light at (913) 551-7528.

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                     Table of Contents
At a Glance


 Chapters           . .,;§ • •    .:;;;;::.    ...;.|;    ..;^.;   ..yg..  :';;g     :>


      1     BioWatch Is Designed to Detect the Release of
           Ambient Biological Agents  	  1

              Purpose	   1
              Background	   1
              Scope And Methodology	   3

      2     EPA Supports BioWatch Program  	   5

      3     EPA Has Not Completely Fulfilled Its Program Responsibilities  	   7

              EPA Did Not Ensure that BioWatch Network Was
                 Deployed and Maintained Adequately 	   7
              EPA Provided Limited Oversight and Quality Assurance	   9
              Technological Assessment Needed to Improve BioWatch Capability	  10
              Consequence Management Planning Incomplete  	  11
              Conclusion  	  13
              Recommendations 	  13
              Agency Comments and DIG Evaluation	  13
              Additional Work  	  14



 Appendices


      A    BioWatch Program Model  	  15

      B    Details on Scope and Methodology  	  16

      C    Agency Comments	  18

      D    Distribution 	  22

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                               Chapter  1
      BioWatch Is Designed to Detect the Release of
                    Ambient Biological Agents
Purpose
            BioWatch is an early-warning system designed to detect the release of biological
            agents in the air through a comprehensive protocol of monitoring and laboratory
            analysis.  BioWatch is a "detect to treat" network intended to detect a biological
            agent within 36 hours of release so that there is time for Federal, State, and local
            officials to determine emergency response, medical care, and consequence
            management needs.  BioWatch is intended to provide coverage for 80 percent of
            the population in select cities.

            The Department of Homeland Security (DHS) funds and oversees the program
            while relying on the assistance and expertise of EPA, Department of Energy
            (DOE), Department of Defense (DOD), the Centers for Disease Control and
            Prevention (CDC), and State and local agencies for sampling, detection
            equipment, lab analysis, and response.

            Our evaluation questions were:

            »  What are EPA's designated responsibilities in the BioWatch program?

            »•  How well is EPA implementing its designated responsibilities in the
               BioWatch program?
Background
            BioWatch was created by DHS because of concern that terrorists could aerosolize
            a biological agent, potentially causing thousands of casualties. Without early
            detection, the magnitude of the problem might only be revealed as people arrived
            at hospitals with symptoms. The BioWatch network was designed to detect
            biological agents in select cities. BioWatch was introduced in early 2003 as part
            of an evolving nationwide bio-surveillance system that looks for early indicators
            of the exposure of people, animals, and plants to biological agents; and uses
            environmental monitoring networks in selected cities that can detect the agent
            directly. Three other initiatives complement BioWatch: BioSense, BioShield, and
            the National Biosurveillance Integration System.  The BioSense program
            examines pre-diagnostic indicators of disease in the population through

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              syndromic surveillance.1 The BioShield program develops, purchases, and
              stockpiles vaccines and facilitates the rapid development of new vaccines for
              biological agents.  The National Biosurveillance Integration System integrates
              Federal, State, local, and private industry biosurveillance and monitoring
              information to identify and characterize potential biological attacks on the nation.

              The Bio Watch program has three components:

              *   Sampling for detection of biological agents
              »•   Analysis of samples
              »•   Response for positive biological agent  detection

              EPA maintains the sampling portion of the BioWatch program because of the
              Agency's experience in air monitoring and ability to provide grants to State and
              local air monitoring agencies conducting daily monitoring activities.  EPA's
              Office of Air Quality Planning and Standards in the Office of Air and Radiation
              coordinates the air sampling component. This sampling component involves
              aerosol monitors mounted on pre-existing EPA air quality stations to detect
              biological pathogens that might be intentionally released by terrorists. The
              aerosol monitors draw in air and pass it through filters, which are manually
              collected at 24-hour intervals, 7 days a week, 365 days a year.2  BioWatch uses
              three types of monitors for air sampling.

              ••   Portable Sampling Unit (PSU)
              -   Dry Filter Unit (DFU)
              »•   Distributed Sampling Unit

              CDC is responsible for coordinating the laboratory analysis of the filters.  State
              and local monitoring agencies deliver filters daily to CDC-operated BioWatch
              facilities located within Federal, State, or local public health laboratories for
              analyses. The filters are analyzed during a primary test for potential biological
              weapon pathogens using polymerase chain reaction (PCR) techniques.3  If a
              biological agent  is detected, lab analysts perform a secondary test. A  positive
              secondary test is considered a PCR-verified positive and indicates the existence of
              a biological material in the air due to either an intentional release or a natural
              occurrence.
        Syndromic surveillance is the monitoring of the population for disease outbreaks by categorizing early signs and
symptoms of disease (the disease "prodrome") into syndromes that relate to the clinical manifestations of certain diseases.

        According to DHS officials, some BioWatch sites increase sample collection to every 8 or 12 hours during high threat
alerts, or immediately following special events. Threat alerts are based on DHS intelligence and a color-coded threat system is
used: Red (Severe); Orange (High); Yellow (Elevated); Blue (Guarded); and Green (Low).

        The PCR technique is used to reveal the DNA sequence of biological material.  Laboratory technicians use PCR to
amplify a particular segment of DNA by repeated cycles of polymerization, to identify whether the DNA matches any of the
biological agents that the BioWatch program monitors.

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              The sampling and analysis portion of the program is designed to detect and
              confirm the presence of biological agents within 36 hours of a release as shown in
              Table l.l.4 Once a positive sample is PCR-verified, confirmational sampling
              determines the geographic extent of the biological agent release and whether it is
              an intentional terrorist activity or naturally occurring.
                  .;•:;•••.24H0W&):;-'' :'.'
                 Aerosd collection cycle
              If a biological agent is confirmed by the laboratory, notification procedures are
              determined at the local level and typically involve contacting local health
              authorities, law enforcement including the Federal Bureau of Investigation (FBI),
              and DHS.  The FBI is designated as the lead agency for the law enforcement
              response if a bio-terrorism act is confirmed.

              A model of the BioWatch program is provided in Appendix A.
Scope and Methodology
              To assess whether EPA has effectively fulfilled the Agency's responsibilities for
              the BioWatch program, we reviewed EPA documents and numerous BioWatch
              reports, and interviewed key stakeholders. We reviewed the BioWatch
              cooperative agreements administered by EPA and observed operations of several
              field collection agencies and health laboratory facilities.  We also attended several
              conferences related to biological agent detection. Preliminary research and field
              work was conducted while collaborating with the Inspector General offices for
              DHS and the Department of Health and Human Services (which oversees CDC
              operations). Our methodology does not allow our observations to be projected to
       Our review did not determine whether 36 hours was an appropriate amount of time to detect a biological agent release
to provide time for Federal, State, and local officials to determine emergency response, medical care, and consequence
management needs.


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all cities served by the BioWatch Program.  However, we believe the problems in
any location, be they systemic or not, are noteworthy and require corrective
action.

We conducted this evaluation in accordance with Government Auditing
Standards, issued by the Comptroller General of the United States.  Our field
work was conducted from July 2004 to November 2004. For more details, see
Appendix B.

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                                  Chapter 2
                EPA Supports BioWatch  Program
             EPA plays a major role in the BioWatch program. DHS uses EPA to award and
             manage cooperative agreements to State and local air monitoring agencies that
             collect the filters. Some State and local agencies use contractors to collect the
             filter samples. EPA is responsible for: establishing, deploying, operating, and
             maintaining the BioWatch network and the filter collection process, including
             policy oversight and assessing technology. A number of documents outline
             EPA's responsibilities, including: The BioWatch Fact Sheet; the Memorandum of
             Agreement among DHS, EPA, and CDC; and the Quality Assurance Project Plan
             for Field Sampling Activities of the Bio Watch Program, as shown in Table 2.1.
                               2.1: EPA's BioWatch Responsibilities
         d«|rtoy, operate, and maintain flit BloWatoti network and filter collection process

  Administer cooperative agreements to fund the BioWatch sampling activities.
  Develop cost estimates and budgets.
  Procure field equipment beyond those procured by DOE,  DOD, and DHS.
  Assist with site evaluation and selection.
  Work with the  EPA regions and State and local organizations to determine the best sampling locations and the
  logistics for sampler deployment and filter transport to laboratories.
  Assist with sampler set-up and initial operation.
  Act as a liaison to groups working on the program and serve as primary liaison to State and local environmental
  agencies.
  Implement a field communications network.
  Implement and coordinate the sampling network and training with State and local environmental monitoring
  agencies.
  Coordinate activities with CDC.
  Develop quality assurance protocols and training.
  Evaluate for re-siting and/or additional samplers.
Provide policy oversight

• Coordinate and/or perform technical systems audits of the field data collection activities.
• Provide quarterly reports.
• Monitor network operations and reliability.
Assess technologies     : :•;  • ' :';'xV'  ••;••?. '  ""x":/

• Evaluate the performance of the BioWatch monitors.
• Pursue newer, more advanced instrumentation.
Source: OIG

             Federal laws, presidential directives, and strategic plans also justify EPA's
             involvement with the BioWatch program, as shown in Table 2.2.

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                             Table 2.2: Support for EPA's Involvement
Homeland Security Presidential Directives 5, 8, and 10
EPA v/ill support and develop the preparedness of State, local, and tribal governments, and private industry, to
respond to, recover from, and continue operations after a terrorist attack.

Clean Air Act
EPA dies the Clean Air Adi (Section 103) as the Statutory Authority for the Agency's involvement in the sampling
component of the BioWatch program. The Clean  Air Act provides the principal framework for national. State, and
local efforts to protect afnbisnt (outdoor) air qualify and designates EPA to set health-based standards, which
control pollutants harmful to people and the environment.

Comprehensive Environmental Response, Compensation and Liability Act, Section 104
EPA responds to releases of hazardous substances, pollutants, and contaminants. A response is coordinated
under the National Contingency Plan, which is the implementing regulation for EPA's Superfund program and
provides guidelines and procedures for responding.

EPA Homeland Security Strategy
EPA's Homeland Security Strategy, dated October 2004, specifies that EPA wiH work with States, tribes, and other
Federal agencies to develop and implement BioWatch.


National Response Plan
EPA has the authority to designate a Federal On-Scene Coordinator to direct response efforts at the scene of a
discharge or release of oil, hazardous substances, pollutants, or contaminants, depending on the substance and
the location and source of release.

Source: OIG
              The capital costs for installation in each city were approximately $1 million, and
              the annual budgeted operational costs were $ 1 million per city.  Details on costs
              are in Table 2.3. The fiscal year 2005 budget included a $65 million increase to
              enhance current monitoring activities.  DHS plans to enhance the number of
              monitors from 10-15 to up to 50 monitors in some cities to ensure coverage of
              80 percent of the population within a city.  The enhancement is expected to go
              beyond EPA's existing monitoring networks to cover subways and other
              facilities.
                    Table 2.3  BioWatch Costs (millions)
                Fiscal
                 Year

                 2003
                 2004

                 2005

               Source: OIG
 Approximate
Sampling Costs

      $12
      $13

     $15'
Approximate
 Total Costs

    $40

    $38

    $129
               ' Does not include funding to support the
               enhancements planned for 2005.

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                               Chapter 3

              EPA Has Not Completely  Fulfilled its

;:	Program  Responsibilities	

            EPA did not provide adequate oversight for the sampling component of the
            BioWatch program, including monitoring State and local agencies and any
            contractors used for filter collection, potentially affecting the quality of the
            samples taken.  EPA completed a technology assessment of the existing
            BioWatch monitors, but needs to continue to be involved in assessing
            technologies that are more reliable and timely  and reduce costs.  The lack of
            consequence management planning was highlighted when a biological agent was
            detected in Houston in 2003. As a result of this incident, EPA collaborated with
            DHS and CDC  on the development of consequence management planning
            guidance, but at the time of our review State and local consequence management
            planning was incomplete. The BioWatch program depends upon the successful
            implementation of each component.  The failure of EPA to completely fulfill its
            responsibilities  raises uncertainty about the ability  of the BioWatch program to
            detect a biological attack.

EPA Did Not Ensure that BioWatch Network  Was Deployed and
Maintained Adequately

            EPA helped to quickly establish the BioWatch network by administering
            cooperative agreements, procuring monitors, and working with State and local
            organizations to set up the filter collection system in 2003.  EPA, however, did
            not provide adequate oversight to ensure that quality standards for BioWatch
            were met. Specifically, EPA did not ensure that BioWatch monitors were
            optimally deployed and secure.

            Some Monitors Not Optimally Deployed

            EPA did not provide adequate oversight of monitor deployment, potentially
            affecting the ability of the monitors to detect biological agents.  For example,
            several BioWatch monitors were not installed  according to EPA guidelines.
            Guidance required monitors to take air samples between the height of 5 and about
            50 feet and be free of obstructions to air flows. We observed monitors sampling
            air below 5 feet, and a monitor on a building rooftop sampling air above 50 feet.
            We also found monitors located next to equipment trailers that obstructed air
            flow.

            The Los Alamos National Laboratory is designated as the primary agency
            responsible for siting issues, but EPA officials acknowledged that they provide
            technical assistance for resiting activities. EPA's Quality Assurance Project Plan


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              also states that EPA will work with regions, States, and local organizations to
              determine the best sampling locations.  Most of the BioWatch monitors were
              initially placed into existing EPA air monitoring sites because of DHS's concern
              to get the network operating rapidly. All 10 EPA regions indicated that monitors
              were resited after deployment for a variety of reasons, including access issues,
              wind patterns not taken into account during modeling, and construction.  For
              example, the modeling used for site selection did not consistently take into
              account certain parameters, such as topography and seasonal wind pattern
              changes, and assumed the biological agent would be released from a stationary
              point rather than from a moving source.5

              BioWatch monitors are located many miles apart, although a Congressional
              Research Service report (The  BioWatch Program: Detection ofBioterrorism,
              November 2003) found that an outdoor biological warning system would require
              the placement of monitors as  closely spaced as 300-500 meters.6 State and local
              agencies expressed concern because the monitors are distributed too widely and
              there are gaps in the coverage. For example, one locality requested and received
              an additional monitor to cover a perceived gap in the downtown area. Another
              locality installed an additional monitor to improve sampling to account for
              seasonal weather variations.  These actions indicate that the existing monitors are
              not optimally located, potentially limiting the detection capability.  DHS plans to
              enhance the BioWatch network in 2005 by adding additional monitors.

              Security Inconsistent at Monitoring Sites

              EPA did not ensure that monitors are consistently placed in secure locations.
              We found monitors placed next to a fence and out in the open, vulnerable to
              tampering and vandalism. One monitor, located outside a fire station, was easily
              accessible during the day through an open gate. Another monitor station had
              graffiti on the equipment trailer.  Also, we observed one site where the equipment
              was not locked because the filter collector experienced trouble with the padlock.7

              DHS considers information about the BioWatch program to be sensitive. For
              example, at a BioWatch training session in Atlanta in February 2003, DHS
              stressed that the program is so sensitive that employees should not discuss it with
              family members.  According to EPA officials, DHS only requires that filter
              collectors be U.S. citizens. Background checks, however, are determined by State
              or local hiring practices, and some State and local agencies do not require
       5EPA plans to revise its quality assurance guidance by April 30, 2005 (see Agency comments in Appendix C, page 21,
of this report).

       6DHS officials stUed that this closeness of monitors may be greater than necessary, depending on the level of detection
of the method used for the specific agent under consideration and the acceptable probability of detection for the population under
surveillance against a reasonably expected agent release.

        EPA plans to conduct security analysis of the BioWatch monitors (see Agency comments in Appendix C, page 21, of
this report).

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             background checks on employees or the contracted filter collectors.  DHS is
             strengthening the language for this requirement, according to EPA officials.

EPA Provided Limited Oversight and Quality Assurance

             EPA did not provide adequate oversight to ensure that quality assurance activities
             were consistently conducted, potentially affecting sample integrity.  EPA
             developed the Standard Operating Procedures for the BioWatch sampling
             activities to ensure that field operators collect samples in a manner that does not
             compromise sample integrity and chain of custody, but did not consistently
             provide the guidance to the State and local agencies collecting the samples.  For
             example, one EPA region did not provide quality assurance documents to six
             localities for almost a year.

             Required Equipment Checks Not Conducted

             EPA did not ensure that required equipment checks were consistently conducted.
             The PSU monitors require quarterly flow rate and leak checks, and weekly timer
             checks, which should alert field personnel of possible equipment problems and
             the need to recalibrate the equipment. We found that one locality had completed
             its first flow rate check a few weeks prior to our visit and several of the monitors
             were not calibrated correctly. A local agency official said they had just
             completed the calibration test because they did not receive guidance on
             performing these tests until 2 weeks prior to our visit.  In addition, the DFU, a
             lower-cost and easier-to-use monitor, was used in 29 percent of the cities EPA
             supports. However, a DFU does not have a timer, flow indicator, or leak check
             device to determine whether the monitor is working properly, creating uncertainty
             in the  ability to detect a biological agent release. In the absence of these data,
             EPA needs to ensure that quality assurance requirements are being completed,
             particularly in light of DHS's plans to enhance the BioWatch network with
             additional monitors.

             Required Progress Reports Not Completed

             EPA has not consistently assured that required progress reports have been
             completed or provided performance information to DHS.  The terms and
             conditions of agreements stipulate that EPA assist with many of the details critical
             to the  sampling collection, including progress reports to ensure field collections
             are conducted according to the  quality assurance protocols. EPA recognized that
             the reports could be used as a troubleshooting tool to identity problems
             encountered and propose resolutions.  During our grant file review, however,
             4 out of 10 EPA regional offices could not initially provide us with required
             quarterly progress reports. In addition, one local agency had not completed the
             required quarterly reports because they were not aware of the requirement and the
             EPA region had not requested the report.  The local agency had not submitted any

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             quarterly reports since the inception of the BioWatch program, a period of 1
             year.8

             EPA's Quality Assurance Project Plan tasks the Agency with developing
             Standard Operating Procedures for sampling, and coordinating and/or performing
             technical systems audits of the field data collection activities. According to EPA
             officials, DHS contracted with an audit firm to conduct the technical systems
             audits, and only asked EPA to supervise the creation of the audit template and
             coordinate the contractor schedule with regional, State, and local officials.  Even
             though the audits were completed, our review determined that quality assurance
             protocols were still not being followed.  For example, our observations about
             monitor siting, security, and equipment checks took place after the DHS
             contractor had audited the same locations.

Technological Assessment Needed to Improve BioWatch Capability

             EPA has completed a technology assessment of the existing BioWatch monitors,
             but needs to continue to be involved in assessing technologies that are more
             reliable, timely, and efficient. The BioWatch sample collection program is labor
             intensive.  The collection of filters from the monitors, processing of filters, and
             laboratory analysis require daily human intervention. Some State and local air
             monitoring agencies have expressed concern about the labor involved with
             BioWatch, particularly during high threat alerts when 8- to 12-hour sampling is
             requested by DHS. Two local agencies stated that they could not participate in
             12-hour sampling due to limited staffing. Therefore,  EPA needs to continue to be
             involved in assessing technologies that could reduce the labor involved in the
             sampling process.

             EPA has evaluated monitor performance and recommended that the PSU monitor
             be used to enhance the BioWatch network.  The Agency's efforts include the
             technical review of instrumentation specifications provided by DHS; aiding in the
             set-up of live agent testing performed by the Los Alamos National Laboratory at
             Dugvvay Proving Ground, Utah; and aiding in the investigation of new data
             management methods and peripheral data collection methods, such as
             meteorological measurements. However, EPA could help assess technologies that
             are more reliable and  timely, and reduce costs. According to the November 2003
             Congressional Research Service report, The BioWatch Program: Detection of
             Bioterrorism, technological assessment and improvement is needed to provide
             detection of more pathogens. For example, DOE is working on a project, called
             the Autonomous Pathogen Detection System, that is to provide automated
             continuous monitoring for many potential biological agents.  The U.S. Postal
             Service also uses the BioHazard Detection System to monitor pieces of mail and
       EPA plans to consistently collect progress reports (see Agency comments in Appendix C, page 22, of this report).

                                          10

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             detect whether there are particles of a specific pathogen coming off those pieces
             of mail.9

Consequence Management Planning Incomplete

             If a biological agent is detected, a consequence management plan is needed to
             guide the local jurisdiction's response during the first 24 to 48 hours. EPA
             collaborated with DHS and CDC on the development of consequence
             management plan guidance but at the time of our review State and local
             consequence management planning was incomplete. The lack of consequence
             management planning was highlighted in October 2003 when tularemia was
             detected by BioWatch monitors in Houston, Texas. The Houston Department of
             Health and Human Services officials did not have a BioWatch consequence
             management plan to follow during the event.

             A consequence management plan provides for the rapid collection of information
             used to assess the risk to public health and identify an appropriate response. The
             plan should be in place prior to a biological event to guide the local jurisdiction.
             The plan should include: identification of roles and responsibilities, a decision
             making process, and a notification protocol.10  Information gathered should
             include:

             •   Collecting confirmational samples.
             •   Performing laboratory analysis  to determine agent viability and concentration
                 levels.
             •   Conducting public health surveillance and  epidemiologic investigations,
                 including veterinary surveillance.
             •   Performing computer modeling and incident reconstruction.
             •   Conducting intelligence analysis and investigation.
             •   Comparing analysis of known pathogens endemic to the region and seasonal
                 trends, including the history of reported human or animal cases not related to
                 bioterrorism.

             Because Houston did not have a consequence management plan, the following
             problems were encountered:

             •   Houston officials believed that  the local hazardous materials response team
                 would take over routine sampling collection if a positive biological agent was
                 detected.  The hazardous materials response team was not trained in the
                 BioWatch sample collection process, however, so regular filter collectors
                 continued to collect the filters.
       EPA plans to assist DHS in investigating and testing new technologies (see Agency comments in Appendix C,
page 22, of this report).
       l°Drafl BioWatch Preparedness and Response Guidance, dated February 5,2004.

                                          11

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              •   Local officials had to collect and discuss information about the characteristic
                 of tularemia after it was detected rather than having it readily available.
              •   The Los Alamos National Laboratory and the National Institute for
                 Occupational Safety and Health sent in staff to assist  with confirmatory
                 sampling. The Houston Bureau of Epidemiology, however, received
                 contradictory reports from various sources regarding what monitoring sites
                 had presumptive positive results and how many of those had confirmatory
                 results.
              •   The Bureau of Epidemiology alerted all sentinel hospitals to obtain reports of
                 syndrome numbers and suspected tularemia cases.  The symptoms supplied in
                 the alert were common to many patients, so hospitals  either reported a large
                 number of cases daily or did not report at all.
              •   Local officials did not have procedures for decontaminating the monitors after
                 a biological agent was detected.

              After 3 weeks of testing and field investigations, the Houston lab determined that
              the tularemia reflected naturally occurring environmental background levels and
              did not require action.  Officials at the Houston lab stated that because tularemia
              is a naturally occurring agent, DHS determined that it is acceptable in Houston to
              increase the concentration of tularemia necessary for the activation of notification
              protocols.  According to EPA officials, both DHS and EPA recognized the lack of
              consequence management planning during deployment, but the Houston event
              prompted DHS to revisit and address the lack of Federal guidance.

              After the Houston incident, EPA participated in the development of consequence
              management response templates with DHS, CDC, FBI, and the national labs to
              provide guidance for consequence management planning. The templates address
              the first steps covering the initial 24 to 48 hours of a response, and were made
              available to each BioWatch city in February 2004. At a BioWatch workshop in
              February 2004, DHS stressed that the response templates were only "guidance"
              that States and locals could use for strategic planning.  During our review, State
              and local agencies consequence management plans were incomplete.  According
              to a February 2004 Government Accountability Office report,11 no State is fully
              prepared to respond to a major public health threat. States have improved their
              disease surveillance systems, laboratory  capacity, communication capacity, and
              workforce needed to respond to public health threats, but gaps in each remain.
              EPA officials said DHS recognizes the need to continue to develop full
              consequence management plan guidance, and intends to focus resources in this
              area in 2005.12
       11 PUBLIC HEALTH PREPAREDNESS: Response Capacity Improving, but Much Remains to Be Accomplished
(GAO-04-458TX dated February 12, 2004.

        EPA plans to provide conseque
comments in Appendix C, page 22, of this report).
EPA plans to provide consequence management assistance to local governments if they request it (see Agency


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Conclusion

             EPA's lack of oversight and quality assurance for the BioWatch program raises
             concerns about the capability of the program and makes it difficult for EPA and
             partnering agencies to ensure that program results are accomplished.  A
             comprehensive assessment of the BioWatch program is needed.

Recommendations

             EPA's Assistant Administrator for Air and Radiation should ensure that:

             3-1   EPA fulfill all BioWatch-designated responsibilities, including such
                   oversight responsibilities as ensuring quality assurance guidance is
                   adhered to.

             Further, although not a responsibility specifically designated to EPA as  part of the
             BioWatch program, we suggest that the Assistant Administrator for Air and
             Radiation have EPA work closely with the BioWatch partners to:

             *  use its air monitoring experience to assist DHS in identifying and testing
                alternative technologies that are more reliable, timely, and efficient for
                detecting biological agents.
             •  ensure the Agency is adequately prepared to assist with consequence
                management plans in the event of a biological agent release.

Agency Comments and OIG Evaluation

      The Agency agreed with our report and stated that it has begun working with EPA
      regions to address many of the issues that we identified. EPA made detailed technical
      comments on our draft report and, where appropriate, we made revisions. The Agency
      response is in Appendix C. We did not include a portion of the EPA response in part
      because it included potentially sensitive information.

      EPA expressed concerns about the sensitivity of the information in the report. We met
      with DHS officials, who stated that our report does not release any sensitive information.
      DHS also made technical comments on our draft report and, where appropriate, we made
      revisions.
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Additional Work
             The success of the BioWatch program is dependent upon the successful
             implementation of each major component - sampling, analysis, and response.
             The effectiveness of the program requires that:

             •   any terrorist release of biological agents into the air of a major city area be
                 detected,
             •   the presence of a bioagent can be confirmed and identified,
             •   the appropriate decision makers are informed in  a timely manner, and
             •   the designated responders are able to execute an emergency response plan that
                 mitigates the effects of the attack on the populace to the greatest extent
                 possible.

             No one agency has the capability to conduct all of the functions required by
             BioWatch.  As we noted previously, DHS funds and oversees the program while
             relying on the assistance and expertise of EPA, CDC, DOE, DOD, and State and
             local agencies for sampling, detection equipment, lab analysis, and response.
             Therefore, to fully assess the ability of BioWatch to respond to a terrorist attack,
             the Inspectors General of Health and Human Services and DHS have initiated
             complementary reviews to specifically address their respective components of the
             BioWatch Program.
                                          14

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                                                                              Appendix A
                              BioWatch Program Model
        As shown below, the BioWatch program has three components: sampling (A), analysis (B),
        and response (C).
         FIELD SAMPLING PORTION (EPA)

A

Agent
release





BioWatch
samples


24 hours
Public inhales
bioagent

Sample
to lab


1-4 hours




B
Lab

2-6 hours
(primary
test)
	 t Public gets _C^
infected




PCR-
ve rifled
positive

2-6 hours
(secondary
test)
Infected
public gets
symptoms
Initial
call
_ "^
2hout

s
Symptomatic
diagnosed



Diagnosed
public gets
treated
Response examples:

 additional environmental
 sample collection
- epiderniologic Investigation
 computer modelling/
 incident reconstruction
Source: OIG
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                                                                       Appendix B

               Details on Scope and Methodology

We conducted this evaluation in accordance with Government Auditing Standards, issued by the
Comptroller General of the United States. Preliminary research and field work was carried out
in collaboration with the OIGs from DHS and the Department of Health and Human Services.
Field work was conducted from July 2004 to November 2004.

We limited the scope of our review to EPA's designated responsibilities for the BioWatch
program. For example, we did not determine whether 36 hours was an appropriate amount of
time to detect a biological agent release, or whether the agents being tested for are supported by
credible threat information. Our methodology does not allow our observations to be projected to
all cities served by the BioWatch Program. However, we believe the problems in any location,
be they systemic or not, are noteworthy and require corrective action.

We reviewed the BioWatch cooperative agreements administered through EPA and grant files
maintained by EPA Regions for the sampling portion of the program for 12 elements including:

*   Sample collection issues
»   Type and number of monitors used
•   Equipment and supply problems
•   Monitor siting issues
•   Progress reports
•   Labor issues
•   Consequence management issues

To assess EPA involvement in the BioWatch Program and whether the Agency has effectively
fulfilled its role, we reviewed numerous reports about air monitoring, bioterrorism, and threat
and risk assessments, including the following:

•   Bio Watch Fact Sheet
•  Memorandum of Agreement among DHS, EPA, and CDC
•   The Quality Assurance Project Plan for Field Sampling Activities of the BioWatch Program
•   Standard Operating Procedures for the Bio Watch Program
•   EPA 's Homeland Security Strategy
•   Draft BioWatch Preparedness and Response Guidance
•   BioWatch Program: Detection of Bioterrorism, Congressional Research Service
•   Homeland Security: Effective Intergovernmental Coordination Is Key to Success (GAO-02-
    1013T)
•   Public Health Preparedness: Response Capacity Improving, but Much Remains to Be
   Accomplished (GAO-04-458T)
•   Combating Terrorism: Need for Comprehensive Threat and Risk Assessments of Chemical
    and Biological Attacks (GAO/NSIAD-99-163)
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We interviewed key stakeholders involved in the BioWatch program, including:

•   EPA's Office of Air Quality Planning and Standards
•   EPA's Regional contacts for BioWatch
•   DHS Director of Science and Technology
•   CDC Chief of the Laboratory Response Branch Bioterrorism Preparedness and Response
    Program
•   State and local monitoring agencies
•   Academia (a professor of Environmental and Occupational Health Sciences)

We attended several conferences related to biological agent detection, including:

•   The National BioWatch Workshop, in February 2004
•   EPA's 2003 Science Forum

As the implementers of the BioWatch network, State and local air pollution control agencies are
critical to the success of the network.  To understand how the BioWatch monitors are operated
and maintained, and how and what type of information is collected, we observed several field
collection operations in different parts of the country. We discussed the issues and challenges
associated with the network and EPA's involvement. To understand the health laboratory and
analytical processes, we observed the laboratories responsible for analyzing BioWatch filters.
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                                                                        Appendix C
                           Agency Comments
MEMORANDUM

SUBJECT:   Response to the Draft Report No. 2004-00313 "EPA Needs to Fulfill Its
             Designated Responsibilities to Ensure Effective BioWatch Program"

FROM:      Jeffrey R. Holmstead
             Assistant Administrator

TO:         Jeffrey K. Harris
             Director for Program Evaluation, Cross-Media Issues

      The purpose of this memorandum is to respond to the recommendations in the draft
report, "EPA Needs to Fulfill Its Designated Responsibilities to Ensure Effective BioWatch
Program, Assignment No. 2004-00313."

      Thank you for providing us the opportunity to respond to the draft report from the Office
of Inspector General (OIG) issued January 7, 2005. We appreciate the recommendations to help
strengthen the BioWatch program, and OAR has already begun working with the Regions to
address many of the issues identified (e.g., reporting, security, quality assurance) in the draft
evaluation. As has been discussed, OAR,  the states, and local agencies responded very quickly
to the request by the Department of Homeland Security (DHS) to help them establish their
BioWatch program. With our collective experience managing the program, we now have the
data and understanding of the program to review and, in some cases, revise procedures and
guidance.

      We have attached three documents. The first document (Attachment A) responds to the
recommendations outlined in the draft evaluation.  The second (Attachment B) provides general
comments on the text of the draft evaluation.  The third (Attachment C) identifies information
that OAR believes may be sensitive and not previously available in the public domain.

      If you have additional questions or require clarifications, please contact Peter Tsirigotis
at (919) 541-9411.

Attachments

cc:    Fredrick Light, Office of Inspector General
      Tom Dunn, Acting Assistant Administrator for Solid Waste and Emergency Response
      Elizabeth Craig, Deputy Assistant  Administrator, Office of Air and Radiation
      Steve Page, Director, Office of Air Quality Planning and Standards, OAR
      Debbie Dietrich, Director, Office of Emergency Management, OSWER
      Thomas Curran, Assistant Director for Information & Program Assessment, OAQPS
      Peter Tsirigotis, Director, Emissions, Monitoring and Analysis Division, OAQPS
                                         18

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Kay Holt, Director, Planning, Resources, and Regional Management Staff, OAQPS
Laurie Trinca, OAQPS Audit Coordinator
                                 19

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Attachment A

Responses to the Recommendations for EPA's Assistant Administrator for Air and Radiation

3-1    ... fulfill all BioWatch-designated responsibilities, including such oversight
responsibilities as ensuring quality assurance guidance is adhered to.

OAR agrees with the OIG recommendation that we fulfill all of our designated Bio Watch
responsibilities which include: monitor deployment, site security, oversight, and assessment of
monitor technology.

The BioWatch program is the first of its kind. We worked with DHS and the state and local
agencies to deploy monitors on an extremely tight schedule because of rising security concerns.
Now that the network has been successfully established, we agree that it is an opportune time to
review the network internally, and with our federal, state and local partners, revise our guidance
and procedures, where necessary.

OAR agrees that there is a need for increased oversight of the programmatic requirements
identified in the grants and Quality Assurance (QA) guidance.  OAR issued Quality Assurance
Project Plan (QAPP) guidance and Standard Operating Procedure (SOP) documentation that was
based upon deployment of an ambient air monitoring network (the fine Particulate Matter
monitoring network). The fine Particulate Matter guidance served as a basis for deploying the
network quickly and with good quality control. Based upon the subsequent experience with the
BioWatch network, OAR now believes that the guidance should be updated for siting and QA,

Particular sites were chosen for specific attributes (in priority order of) latitudinal and
longitudinal location, 24/7/365 access, security, and other site attributes. OAR gave top priority
to have a monitor operating in some capacity in a given area around a certain latitude/longitude,
as prescribed by modeling by Los Alamos National Laboratory, in order to properly protect
selected population areas. In some cases, BioWatch monitors were sited in less than perfect
conditions, which may not meet the QAPP guidance, but which provided proper area coverage.
An example in the report references monitors being above QAPP  height requirements. This
situation was in some cases impossible to avoid due to the priority to be near a certain latitude
and longitude. OAR plans to work with the Regions to revise the OAPP and SOP bv April 30th
to properly reflect monitor siting criteria priorities more specific to BioWatch. while still striving
to meet the best possible balance between location and physical siting.

With regard  to securing BioWatch monitors, field operators are required to maintain the site and
ensure that the monitor is physically locked at a minimum, and  when possible, secure from
tampering.  OAR has asked the EPA regions to work with the states and locals to monitor the
sites for security problems and correct, as needed.  OAR will ensure that our grantees make their
best efforts to maintain security at BioWatch sites, including the safekeeping of the monitors
themselves.  Eight of the ten Regions have completed their security analysis by the date of this
memorandum.

With regard  to oversight and quality assurance, OAR agrees that this area merits additional
attention and efforts are already underway to collect past due QA  reports and to consistently
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gather quarterly and annual reports to be reviewed by the regions.  OAR plans to clearly define
the role of Headquarters and Regional staff with respect to performing Technical Systems
Audits, which will be reflected in the revised guidance. OAR will create a standardized format
for the QA reports during the process of revising the QAPP and SOP to properly reflect the vital
information that must be reported, such as sample collection completeness, equipment
operability, staffing issues (including background checks), and consumable inventory status.

OAR also plans to review the existing grant language used in the BioWatch grants to ensure that
the issues raised in the draft evaluation are addressed in the grants.

3-1 a  Further, although not a responsibility specifically designated to EPA as part of the
BioWatch program, we suggest that the Assistant Administrator for Air and Radiation have EPA
work closely with the BioWatch partners to:

   a) Use its air monitoring experience to assist DHS in identifying and testing alternative
   technologies that are more reliable, timely, and efficient for detecting biological agents.

      OAR is actively involved and will continue to assist DHS and LANL in the investigation
      and testing of prospective new technologies  for the BioWatch program.  Activities
      include:

   •  Participation in the LANL sponsored test-bed called BioNet that is field testing four
      prototype biological agent monitors.
   •  Participating in test planning with LANL for the live agent testing of BioWatch
      prototypes at Dugway Proving Grounds.
   •  Reviewing vendor solicitations for prototype BioWatch monitors and modifications to
      existing BioWatch monitoring hardware.
   •  Reviewing and advising on alterations being made to existing  BioWatch data acquisition
      and data management hardware and software.

   b) Ensure the Agency is adequately prepared to assist with consequence management plans
      in the event of a biological agent release.

      BioWatch  is an evolving program, and consequence management planning is proceeding
      as quickly  as possible given the competing demands that other Homeland Security issues
      are making on local, state and federal agencies. EPA is aware that BioWatch
      consequence management planning is incomplete and we will continue to provide
      assistance to local governments in developing these plans if they so request.  This
      assistance  will be provided by  Regional emergency response staff, and the Assistant
      Administrator for Solid Waste and Emergency Response is the National Program
      Manager for that effort.
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                                                                       Appendix D
                                 Distribution
Office of the Administrator (1101 A)
Assistant Administrator for Air and Radiation (6101 A)
Deputy Assistant Administrator for Air and Radiation (6101 A)
Agency Followup Official (the CFO) (2710A)
Agency Followup Coordinator (2724A)
General Counsel (40IOA)
Audit Followup Coordinator, Office of Air and Radiation (6102 A)
Associate Administrator for Congressional and Intergovernmental Relations (1301 A)
Associate Administrator for Public Affairs (1701 A)
Director, Office of Regional Operations (1108 A)
Director, Office of Air Quality Planning and Standards (C404-04)
Deputy Director, Office of Air Quality Planning and Standards (C404-04)
Audit Liaison, Office of Air Quality Planning and Standards (C404-2)
Director, Office of Homeland Security (1109A)
Inspector General (2410)
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