U. S. Postal Service Emergency Preparedness Plan for Protecting Postal Employees and Postal Customers From Exposure to Biohazardous Material and for Ensuring Mail Security Against Bioterror Attacks Emergency Preparedness Plan Date of Report: March 6, 2002 Postal Service Transmittal Letter Blank Page Table of Contents Section Page Executive Summary ES-1 Preface PR-1 1 Introduction 1-1 1.1 History 1-1 1.2 Initial Response to Anthrax Contamination 1-2 1.2.1 Establish Employee Personal Protection Program 1-2 1.2.2 Provide Medical Support and Cover Medical Costs 1-2 1.2.3 Perform On-Site First Response/Environmental Testing 1-2 1.2.4 Perform Site Cleanup 1-2 1.2.5 Obtain Irradiation Equipment and Decontaminate Mail 1-2 1.2.6 Create Nationwide Mailing, Messaging, and Communication Program 1-3 1.3 Current Actions 1-3 1.4 Background 1-4 2 Assumptions, Methodology, and Approach 2-1 2.1 Assumptions 2-1 2.2 The Framework for the Analysis 2-1 2.3 Methodology 2-2 2.4 Approach 2-2 2.5 Results 2-4 3 Survey of Available Strategies and Technologies to Meet Biohazardous Threats 3-1 3.1 Prevention 3-1 3.2 Protection and Health-Risk Reduction 3-1 3.3 Detection and Identification 3-1 3.4 Intervention-Precautionary 3-1 3.5 Decontamination 3-2 3.6 Investigation 3-2 3.7 Technologies and Processes Under Considerations 3-2 3.7.1 Prevention 3-2 3.7.2 Protection and Health-Risk Reduction 3-3 3.7.3 Detection and Identification 3-3 3.7.4 Intervention 3-4 3.7.5 Decontamination 3-4 3.7.6 Investigation 3-5 4 Analysis 4-1 4.1 Scope and Approach 4-1 4.2 Qualitative Risk Assessment 4-1 4.2.1 Prevention 4-6 4.2.2 Protection and Health-Risk Reduction 4-10 4.2.3 Detection and Identification 4-14 4.2.4 Intervention 4-23 4.2.5 Decontamination 4-29 4.2.6 Investigation 4-33 5 Conclusions 5-1 5.1 Prevention 5-1 5.2 Protection and Health-Risk Reduction 5-1 5.3 Detection and Identification 5-2 5.4 Intervention 5-3 5.5 Decontamination 5-3 5.6 Investigation 5-4 6 Plan 6-1 6.1 Overview 6-1 6.2 Initial Response 6-2 6.3 Near-Term Strategy 6-2 6.4 Intermediate-Term Strategy 6-6 6.5 Long-Term Strategy 6-7 6.6 Outlook and Next Steps 6-7 Glossary GL-1 Appendix A USPS Environment, Facilities, and Mail Flow A-1 Appendix B Prevention B-1 Appendix C Protection and Health-Risk Reduction C-1 Appendix D Detection and Identification D-1 Appendix E Intervention E-1 Appendix F Decontamination F-1 Appendix G Investigation G-1 Appendix H Interoffice Memorandum H-1 Executive Summary Introduction On September 11, 2001, the terrorist attack on the World Trade Center in New York damaged two postal facilities. In October 2001, some individual or group of individuals used the U.S. Mail to send anthrax to organizations and individuals in the United States, harming both employees and customers-5 people died, and 18 became ill. Two postal facilities have been temporarily closed (Brentwood Facility in Washington, D.C., and Hamilton Township Facility in New Jersey). Numerous facilities had to be tested for the presence of anthrax, and many had to be cleaned. Hundreds of postal employees were tested for exposure to anthrax, and many more were put on a regimen of antibiotics for prophylactic purposes. Unlike the large-scale biological attack predicted by experts that could kill thousands, if not hundreds of thousands, this attack was small and carefully targeted. Biological weapons of mass destruction were feared as part of an "asymmetric strategy" on the part of less powerful state or non-state actors. This attack has demonstrated the asymmetric value of introducing a biological agent into a nationwide distribution network. Not only is the relative power of the attacker small, it also means that a small-scale, carefully targeted attack can cause reactions far beyond the actual threat. It was correctly predicted that "an NBC [Nuclear, Biological, or Chemical] attack against a civilian population would, in all likelihood, trigger a panic far in excess of the real effects of the weapons." This panic was magnified by the use of the nation's most extensive logistics network-the U.S. Mail. The U.S. Postal Service delivers 680 million pieces of mail per day to virtually every household and business in the United States. Compromising this system has the potential to adversely impact the entire nation with a simple terrorist act. The Postal Inspection Service has provided the Postal Service a threat assessment, which serves as a basis for this plan. The Postal Inspection Service maintains a continuous liaison with all appropriate federal law enforcement agencies and monitors threats to the nation and its mail. (The threat assessment is not a public document, due to security concerns.) The threat assessment states, in part, "the sheer size and presence of the Postal Service makes it vulnerable to be a target of terrorism or to be used as a vehicle to carryout terrorist activities. The Postal Service is not immune to the possibility of being a terrorism target again and we believe the threat level increased with the media publicity surrounding the delivery of the anthrax laden letters to the Senate." The threat assessment concludes, "Accordingly, the Postal Service believes, and is acting on the assumption that the threat for the inappropriate use of the mails continues." "The greatest opportunities to limit the damage of covert NBC attacks, or prevent them entirely, exist during the first phases of the incident." This report emphasizes just such an approach. It places a premium on threat identification combined with protection to both employees and customers of the Postal Service at the earliest feasible point in our distribution system. "There is an unavoidable tradeoff between maintaining the values and strengths of a free nation and taking certain steps that could significantly increase the odds of gaining advance detection of a terrorist or covert NBC attack." We have considered several different process and technology changes to reduce the volume of high-risk mail from anonymous senders. However, a cornerstone of the service we provide our nation is an open and accessible system. While we can take steps to reduce the volume of high-risk mail from anonymous senders, we cannot eliminate it. A closed and restricted system for the acceptance of all mail is inconsistent with a viable U.S. Postal Service. The safety of our employees and customers, the security of the mail, and the confidence of the American public in the Postal Service were challenged by the events of last fall. Day-to-day postal operations were disrupted, and the negative financial impact on the Postal Service and on our nation's economic activity was significant. We cannot assume these attacks were isolated and will never be repeated. Rather, we must assume our vulnerability is known and we must take the appropriate steps to reduce risk. Overview The Postal Service looked at a variety of process changes and technology initiatives that could be applied to the threat of biohazards in the mail. Careful review and consideration was given to all processes and technologies in this report. The paramount conclusion is that no single solution exists to solve the problem of using the mail as a tool of bioterrorism. Further, no solution or even series of solutions can totally eliminate the threat. The conclusions, and the implementation plan in this report, reflect the need to put in place process changes and technology applications that can reasonably reduce risk. The objective is to reduce risk for both employees and customers of the Postal Service while at the same time maintaining current service levels. The viability of the Postal Service, and its value to the American people, is dependent upon an open and accessible system. Extreme procedural changes could reduce threats, but would significantly damage the financial position of the Postal Service. The procedural changes included in this report reflect the balance between enhanced security and the continued ability of customers to do business with the Postal Service. The technology assessment in this report considered several risk factors. First, at what state of development is the technology? In many cases, there are very interesting developments underway but remain several years from full production capability. Second, to what extent can the technology be integrated into the Postal Service operating system? Heavy emphasis was placed on the ability to maintain current service levels. Third, what is the cost of the technology? There are several approaches that simply do not provide a sufficient level of risk reduction to justify their cost. Finally, what are the levels of risk reduction? Proposals vary as to the level of protection provided and the point at which they should be deployed in our system. We concluded that there was a need to focus our efforts on a combination of procedural changes and technologies that are at or near production. However, while we continue to evaluate these system-wide applications, our first priority will be the cleaning, decontamination and reopening of both the Brentwood and Trenton facilities. This work was begun as part of our initial response and will continue during the next phase. System-wide detection technology is focused on the initial operation in processing facilities for mail picked up at collection boxes, residences, and small businesses -- mail with the greatest risk. This technology, combined with enhanced security procedures for our bulk quantity mailers, provides significant risk reduction as mail enters our distribution system. In order to provide another layer of protection, we will install a vacuuming and filtration system on many of our automated sorting machines. In controlled laboratory tests we were able to replicate the anthrax dispersion events that took place in Trenton and Brentwood. We have a clear understanding of how a powderized biohazard escapes from the mail. Based upon this knowledge we worked with the manufacturers of our processing equipment to design and build the vacuum/filtration systems. These systems are capable of capturing and trapping most of the biohazardous material as it escapes from the mail. The result is reduced risk to the postal employees operating this equipment and in turn reduction in cross-contamination that can affect our customers. We will continue to work with the manufacturers of irradiation technology. This technology remains the only scientifically accepted means to decontaminate mail exposed to biohazards. The electronic beam (e-beam) systems we purchased will be deployed in a configuration optimized for mail. This limited deployment will allow us to accurately evaluate the operational impacts, costs and effects on mail and its contents. The results of this evaluation, combined with the effectiveness of the technologies described above, will dictate the appropriate next steps for irradiation technology. In addition, we will continue to work with manufacturers of alternative technologies to determine whether these technologies could be used to decontaminate mail. Beyond these first steps, we will continue to work with the manufacturers of several different technologies. Additional testing and prototyping is necessary to fully determine their viability. Key areas of focus are (1) redesign of collection box for both risk reduction and detection, (2) technology and procedures to reduce the volume of "anonymous" mail, (3) further deployment of vacuum/filtration technology on automated sorting equipment, (4) use of mass spectrometry for detection, and (5) a variety of technology to aid investigators in finding whoever committed this act, and deterring further attempts at placing biohazards in the mail. This plan is dynamic. We will work with the Inspection Service to periodically update the threat assessment. At the same time, we will continue to evaluate a variety of technologies as they reach maturity. We also are committed to exploring research and development efforts to identify new approaches to solve this problem. Format of the Report The report is presented in six parts. It begins with an introduction that provides background information and a summary of the initial responses to anthrax contamination. The second section outlines the assumptions, methodologies and framework for analysis used throughout the report. The third section provides a structure for grouping the various categories of both process change and technology. It includes a short-listing of the technologies and process changes that were proposed and initially evaluated. The fourth section provides the detailed analysis of the most promising technologies or process changes that were considered. For each item there is a brief description, technical risk assessment, operational risk assessment, cost risk assessment and finally a bottom-line viability assessment. The fifth section draws upon the analysis portion of the report and provides the conclusion as to the combination of technology and process change that should be adopted. The sixth, and final, section provides a plan as to how these technologies and process changes should be implemented. It places these items in a near-term (current fiscal year), intermediate-term (2-3 years), and long-term (4-5 years) format. It also addresses issues for future consideration. Goals This Emergency Preparedness Plan addresses the requirements of P.L. 107-117 and its goals of protecting postal employees and postal customers from exposure to biohazardous material and safeguarding the mail system from future bioterror attacks while maintaining current service levels to the American public. To achieve this goal, four strategic objectives are being pursued: Detect biohazardous materials introduced into the mail stream as soon as possible Contain biohazardous materials identified in the mail stream as soon as possible Neutralize biohazardous materials found in the mail stream Deter against the use of the mail as a tool for bioterrorist acts This will be accomplished by taking action along six core technology-based and process-based initiatives: Prevention - Reduce the risk that someone would use the mail as a tool of terror. Protection and Health-Risk Reduction - Reduce risk of exposure to biohazards, and prevent cross-contamination of mail if biohazards should be introduced into the mail system. Detection and Identification - Detect and identify potential hazardous materials as early as possible in the mail stream. Intervention - As a precaution, neutralize potential contaminants in the mail. Decontamination - Eliminate known contaminants, both in the mail and in equipment and facilities. Investigation - Enhance criminal investigative infrastructure to enable more effective forensic analysis. Conclusions The conclusions that follow are drawn from the qualitative analysis of technologies and processes. The viability of the various technologies and processes has been categorized as immediate, near-term (current fiscal year), intermediate-term (2-3 years), and long-term (4-5 years). The overall availability and state of maturity of technologies in these areas, and their adequacy to accomplish the objectives of each core initiative are also considered. This section is organized by core initiatives, to facilitate reference to the analysis. Prevention The application of detection, containment, and decontamination technologies at the collection box cannot be immediately implemented. The fact that the Postal Service has approximately 350,000 collection boxes, and the current state of detection technology make immediate introduction of these technologies impractical at this time. Several technologies are being conceptually evaluated and will be tested and prototyped in the intermediate term, where appropriate. The use of intelligent mail (each piece of mail having a unique identity) is an effort that predates the current problem with biohazards. The Postal Service has already invested in the infrastructure to support this effort. The basis for this investment has been for business reasons -- both revenue generation and cost reduction -- and was not motivated by security reasons. The effort will continue and assist the Postal Service with its security needs. The Postal Service currently has a program that video records retail transactions. The system is not fully implemented at all postal facilities. In addition there are available image recording systems that would need to be integrated with our information systems to allow us to fully benefit from this technology. Prototyping this system will be necessary to better understand system requirements and cost. Security control for large mailers is viable in the near to intermediate term. This will help ensure that mail from identified sources is secure. Access security control can be accomplished by borrowing heavily from technologies already in place in other areas of the government. In summary, prevention involves a large spectrum of efforts to incorporate technologies at several different levels of maturity. Significant progress is expected in the intermediate term. Protection and Health Risk Reduction The objective of this initiative is to reduce the risk of exposure to biohazards, and prevent cross-contamination of mail, if biohazards should be introduced into the system. Mature and available technologies exist to support this initiative. The protection of employees from air-borne biohazards will be accomplished by the implementation of two mature technologies and by the conduct of a feasibility study in a third conceptual area. The use of high-efficiency particulate air (HEPA)-filtered vacuum cleaners for equipment cleaning, as a replacement for compressed air blowing is a mature and available technology that can be implemented immediately with low risk. The retrofitting of custom-designed filtration vacuum systems on each type of mail-processing equipment involves applying the mature technologies of vacuum systems and multi-stage HEPA filtering in a custom design that can be prototyped and implemented on a large scale in the near to intermediate term with low risk. The installation of enhanced filtration or other means of trapping or killing of bacteria or other bioagents in the heating, ventilation, and air conditioning (HVAC) system is a concept that involves the potential application of a variety of technologies. A preliminary feasibility study is required to define the technical and operational risk of this approach in the context of the implementation of the above two mature technologies, and to identify the technologies that should be evaluated more rigorously for potential insertion into the HVAC. Implementation of the two mature technologies will reduce the health risks to our employees and protect our customers. If the modification of HVAC appears feasible it will provide a further means to reduce health risk. Detection and Identification The objective of this initiative is to detect and identify potential hazardous materials as early as possible in the mail stream. Technologies for detection and identification of threats are not at a stage of development that allows immediate implementation. However, promising cutting-edge technologies exist to effectively accomplish this initiative in the intermediate term, after appropriate testing and pilot studies have been done. Triggering technologies are not at the stage of maturity where commercial off-the-shelf equipment will provide continuous, unattended monitoring and reporting of the existence of a potential threat. These technologies require intermediate-term testing to determine further viability. Confirmation technology requires specific and reliable identification of a biohazard with a validated technique. For this purpose, polymerase chain reaction (PCR) as a means of detecting the presence of specific biohazard signatures is a technology that merits near-term prototyping with potential near- to intermediate-term implementation. Mass spectrometry as a confirmation technology is of moderate to high technical risk due to questions about the specificity of the method and its ability to function in the high-particulate environment of mail processing. If technical risk related to specificity of this technique could be overcome, this combination could also provide acceptable confirmation of a threat. In summary, while detection cannot be accomplished by immediate implementation of an off-the-shelf technology, near-term prototyping of intermittent air sampling, and automated presentation of samples to analysis by PCR shows the best promise for effective detection. Intervention The objective of intervention is to neutralize potential contaminants in the mail. This is a precautionary measure. A mature technology-e-beam-has been identified and implemented for the irradiation of selected mail. The two facilities presently in use were not specifically designed for mail; therefore, the configuration is not optimal. Plans are moving forward for the deployment of e-beam technology in at least one, and potentially two facilities specifically designed for mail processing. Only targeted mail would be irradiated at this facility. This optimal configuration will allow for a better evaluation of the costs, operational impacts, and effects on the mail and its contents. Results of this deployment will largely determine the viability of a large-scale use of irradiation technology. Decontamination - Mail The objective of decontamination is to eliminate known contaminants in the mail. Decontamination of mail involves the sterilization of selected items of mail, which have been identified as being contaminated. It is essentially the same process as intervention, except that it would be applied selectively to mail that is pre-identified as contaminated. Irradiation remains as the only scientifically accepted method for decontaminating mail once it is exposed to a biohazard. No other technology has yet proven the ability to effectively penetrate and clean a non-homogenous product such as mail. Decontamination - Facilities and Equipment Gaseous treatment technologies were found to be the most viable for facility decontamination because of their uniform permeation throughout the facility and exposure to all surfaces accessible to contamination. Of the gaseous treatment technologies, chlorine dioxide is the most viable because of the precedent for its use as a building decontaminant. Spot decontamination can be effectively accomplished with the direct application of anti-microbial agents. Investigation The objective of investigation is to enhance the criminal investigative infrastructure to enable more effective forensic analysis. The technologies under evaluation and development for this initiative are image capture and analysis, wide field of view cameras, and mailpiece tracking. Image capture and analysis is based on real-time analysis of images that are presently captured. This is an ongoing Postal Service project with three distinct phases. The first two phases that include the capability to perform automated, real-time analysis of scanned images have intermediate-term viability. Phase III, which includes handwriting comparison, is somewhat less mature. The use of the full mailpiece image utilizing a Wide Field of View (WFOV) camera is a critical component to this effort. This camera upgrade was previously funded and approved by the Postal Service as part of its normal investment projects. Full deployment of the WFOV will be completed in the next two years. Full image capture is already available on Postal Service automated flats distribution equipment. Plan Initial Response Ongoing activities resulting from this initial response include the purchase of approximately 16,000 HEPA-filtered vacuums for cleaning equipment and building surfaces within postal facilities of 5000 square feet or larger, the provision of gloves and masks to all employees, the use of e-beam technology for mail sanitization, and decontamination of equipment and facilities. (Reference Table 1) Table 1 Usage of Initial Appropriations Near-Term Strategy The Postal Service's near-term strategy is based on using available production (or near-production) technologies and processes to provide initial security capabilities. The Postal Service's implementation of these capabilities over the next year is intended to provide a level of protection and adequate time to allow subsequent investigation and validation of emerging technologies. The first priority of our near-term activity is the continuation of equipment and facility decontamination at the Brentwood and Trenton facilities, and repair of the postal facilities damaged in New York City. Our next priority is detection technologies, principally based on PCR technology, which will be used in conjunction with air sampling. Further operational testing of PCR equipment for use in postal environments will occur before full deployment in processing and distribution centers. Protective and health-risk reduction technologies include the design and installation of filtration vacuum systems on processing equipment at 292 locations for initial induction operations. The first priority is the loose mail culling "010" systems, the Advanced Facer Canceler Systems (AFCS), followed by the outgoing Delivery Bar Code Sorters (DBCS) and the Automated Flats Sorting Machines (AFSM 100). This will provide for significant risk reduction to postal employees and greatly limit cross-contamination should a biohazard event occur in the future. Intervention, in the form of e-beam irradiation, will continue for all mail being delivered to government offices within the 202 to 205 ZIP Codes. In addition, construction will begin on at least one, and potentially two facilities to house the eight e-beam accelerators purchased as one of the initial response actions. Once construction of these facilities is complete and the e-beam equipment is installed it will be available for continued intervention activities as well as decontamination of mail, should future bioterrorism attacks occur against the Postal Service. Finally, research and development activities, pilot testing, and emergency response planning and training will continue. The estimated cost for near-term activities is $587 million. (Reference Table 2) Intermediate-Term Strategy The Postal Service has identified an initial set of technologies that it will evaluate during the next 24 to 36 months. These technologies are intended to build on the baseline of technologies selected for near-term implementation. The Postal Service will both evaluate these intermediate-term technologies and pursue new technologies that have potential benefits. The Postal Service will establish an on-going team that will be specifically tasked with identifying, evaluating, and developing technologies during this time period. Technology-based activities under prevention will be focused on minimizing the "anonymous mailer" threat at collection boxes and retail outlets. Manufactured mail security and vehicle access control will be strengthened. Protection and health-risk reduction activities will continue efforts to install vacuum filtration systems on mail-processing equipment, including the remaining DBCS and Carrier Sequence Bar Code Sorters (CSBCS). It will also investigate the feasibility of adding high-efficiency filtration and sanitization technologies to postal facility HVAC systems. Under Detection, the use of mass spectrometry as both a triggering and confirmation technology for biohazards will be explored with the expectation that it could complement PCR. Investigation will deal with a series of process-based activities aimed at both deterring and identifying terrorists. The estimated cost for intermediate-term activities is at $1.7 billion ($800 million in FY-03, $897.5 million in FY-04), as shown in Table 2. Long-Term Strategy The Postal Service's long-term strategy is focused on technology deployment and process changes based on the research and development activities and pilot tests conducted during both near-term and intermediate-term phases. This continued development activity could result in further maturing technologies that could be deployed in the 4 to 5 year time frame. The long-term strategy must reflect the dynamic nature of this plan. Updates will include an ongoing evaluation of threats. Threat assessment must consider an ever-changing array of biohazards that may be placed in a form suitable to pose a threat in the mail. In addition, assessment must evaluate the threat of explosives, chemical agents and radioactive material. Periodic updates will reflect the further maturation of a variety of technologies under consideration. It will also be necessary to continue to investigate new technologies that may offer viable solutions. Reference Table 2 for long-term cost estimates for planning purposes. Table 2 Ongoing and Proposed Initiatives Costs Note: These estimates are for planning purposes only. Funding will be prioritized to account for any necessary changes. Summary We are proceeding on the basis of the Inspection Service assessment that the inappropriate use of the mails is a continuing threat. Potentially, the mail can be used to transmit a variety of threatening materials, including biohazards. This plan provides for the process changes and technology applications necessary to ensure the enhanced safety of both postal employees and postal customers. The emphasis is placed upon prevention, detection, and risk reduction at the earliest point feasible in our distribution network. The applications utilized in both prevention and detection rely upon mature or near-mature technology. In the case of PCR, piloting and testing is moving forward at a pace that will allow for its near-term deployment. The use of this type of proven technology provides for a systems approach with effective and reliable results. This plan makes optimal use of the appropriated funds. The combination of process change and an array of technology applications across prevention, detection, and risk reduction provide maximum protection for employees and customers. Preface The Department of Defense Appropriations for the fiscal year ending September 30, 2002, HR 3338, authorized $500 million funding "to protect postal employees and postal customers from exposure to biohazardous material, to sanitize and screen the mail, and to replace or repair Postal Service facilities destroyed or damaged in New York City as a result of the September 11, 2001, terrorist attacks." (Enacted as Public Law 107-117, signed January 10, 2002.) In the Joint Explanatory Statement accompanying the bill, the conferees stated they are pleased with the current actions and progress made by the Postal Service to date. Additionally: "The conferees further believe that additional actions taken by the Postal Service should be based on a comprehensive emergency preparedness plan." "As part of its emergency preparedness plan, the conferees expect the Postal Service to include an assessment of threats to the health and safety of employees and customers of the Postal Service and the integrity of the mail; testing and evaluating the options for detecting and/or addressing those threats, including both technology-based and process-based options; a comparison of the costs and benefits of options under consideration; an evaluation of the strengths and weaknesses of the technologies under consideration for mail sanitization, including an analysis of risks to human health and safety and to mail products associated with each of those technologies; and a timetable for implementing the options selected." This document contains the U. S. Postal Service (USPS) Emergency Preparedness Plan as defined by the bill focusing on the technology-based and process-based initiatives that together establish multiple layers of protection against the use of the mail as a tool of terrorism and that protect Postal employees and customers from exposure to biohazardous material while maintaining the current level of service to the American public. Section One Introduction 1.1 History On September 11, 2001, the terrorist attack on the World Trade Center in New York damaged two postal facilities. In October 2001, an individual or a group of individuals used the U.S. Mail to send anthrax to organizations and individuals in the United States, harming both employees and customers-5 people died, and 18 became ill. Two postal facilities have been temporarily closed, the Brentwood Facility in Washington, D.C., and the Hamilton Township Facility in New Jersey. Numerous facilities had to be tested for the presence of anthrax, and many had to be cleaned. Hundreds of Postal Employees were tested for exposure to anthrax, and many more were put on a regimen of antibiotics for prophylactic purposes. Unlike the large-scale biologic attack predicted by experts that could kill thousands, if not hundreds of thousands, this attack was small and carefully targeted. Biologic weapons of mass destruction were feared as part of an "asymmetric strategy" on the part of less powerful state or non-state actors. This attack has demonstrated the asymmetric value of placing a biologic agent into a nationwide distribution network. Not only is the relative power of the attacker small, it also means that a small-scale, carefully targeted attack can cause reactions far beyond the actual threat. It was correctly predicted that "an NBC [Nuclear, Biological, or Chemical] attack against a civilian population would, in all likelihood, trigger a panic far in excess of the real effects of the weapons." This panic was magnified by the use of the nations most extensive logistics network-the U.S. Mail. The U.S. Postal Service delivers 680 million pieces of mail per day to virtually every household and business in the United States. Compromising this system has the potential to impact an entire nation in one simple terrorist act. The Postal Inspection Service has provided the Postal Service with a threat assessment as a basis for this plan. The Postal Inspection Service maintains a continuous liaison with all appropriate federal law enforcement and monitors threats to the nation and its mail. (The threat assessment is not a public document, due to security concerns.) The threat assessment states, in part, "the sheer size and presence of the Postal Service makes it vulnerable to be a target of terrorism or to be used as a vehicle to carryout terrorist activities. The Postal Service is not immune to the possibility of being a terrorism target again and we believe the threat level increased with the media publicity surrounding the delivery of the anthrax laden letters to the Senate." The threat assessment concludes, "Accordingly, the Postal Service believes, and is acting on the assumption that the threat for the inappropriate use of the mails continues." "The greatest opportunities to limit the damage of covert NBC attacks, or prevent them entirely, exist during the first phases of the incident." This report emphasizes just such an approach. It places a premium on threat identification combined with protection to both employees and customers of the Postal Service at the earliest feasible point in our distribution system. "There is an unavoidable tradeoff between maintaining the values and strengths of a free nation and taking certain steps that could significantly increase the odds of gaining advance detection of a terrorist or covert NBC attack." We have considered several different process and technology changes to reduce the volume of high-risk mail from anonymous senders. However a cornerstone of the service we provide our nation is an open and accessible system. While we can take steps to reduce the volume, we cannot eliminate it. A closed and restricted system for the acceptance of all mail is inconsistent with a viable U.S. Postal Service. The safety of our employees and customers, the security of the mail, and the confidence in the Postal Service by the American public were challenged by the events of last fall. The day-to-day operations of the postal system were disrupted, and the negative financial impact on the Postal Service and on United States economic activity was significant. We cannot assume that these attacks were isolated and will never be repeated. Rather, we must assume our vulnerability is known and take the appropriate steps to reduce risk. 1.2 Initial Response to Anthrax Contamination The initial response of the Postal Service to these events included employee protection (testing, treatment, education, communications, and protective wear), building and equipment testing, building and equipment decontamination, and mail decontamination. These actions were taken after consultation with Postal employee union representatives, the Office of Homeland Security, the Centers for Disease Control and Prevention, the Federal Occupational Safety and Health Administration, the Environmental Protection Agency, the Office of Science and Technology Policy, the National Academy of Science, and other scientific, health, and safety organizations, both public and private. 1.2.1 Establish Employee Personal Protection Program Gloves, masks, and other protective gear were purchased and provided to all employees as soon as the need was recognized. High-Efficiency Particulate Air (HEPA) filtering vacuums were obtained for custodial and maintenance cleaning. 1.2.2 Provide Medical Support and Cover Medical Costs As the impact of the anthrax contamination became more apparent, a formal proactive employee-, building-, and equipment-testing program was instituted. When completed, 8,424 employees were offered antibiotics for prophylactic purposes. 1.2.3 Perform On-Site First Response/Environmental Testing In order to determine the condition of sites of possible contamination, and to evaluate specific downstream sites and random sites throughout the country, test equipment, systems, and contract services were obtained. When testing was completed in late November 2001, 284 facilities were tested, with 23 positive and 261 negative results. 1.2.4 Perform Site Cleanup Where localized building or equipment contamination was found, protective safety and health measures were undertaken and decontamination activities were performed. At two locations-Washington, DC, and Trenton, NJ-contamination was found throughout the Processing and Distribution Centers; consequently, the facilities have been shut down completely, and clean up has begun. 1.2.5 Obtain Irradiation Equipment and Decontaminate Mail Mail from the Brentwood and the Trenton facility was immediately quarantined. Arrangements were made with two commercial organizations to assist in sanitization of this mail through the use of electron-beam (e-beam) irradiation. 1.2.6 Create Nationwide Mailing, Messaging, and Communication Program Direct mailings, special internal messages, and stand-up talks were undertaken with postal employees. A national mailing to all customers took place. There were daily news briefings, and the Postal Service Web page was continuously updated to keep employees, customers, and the American public fully informed. At the time of this writing, employee testing and treatment and building and equipment testing are largely complete. Except for Brentwood and Trenton, building and equipment decontamination has been completed. (Planning is in process for decontaminating these two facilities.) Most First Class Mail from Brentwood and Trenton has been decontaminated. (Larger items are still quarantined awaiting availability of X-ray-capable irradiation systems.) As a precautionary measure, mail sanitization for selected destinations is currently an ongoing activity. 1.3 Current Actions Throughout this period, Postal Service senior management, union leaders, stakeholders, and representatives of the White House, Senate, House, and other governmental agencies met regularly. These discussions focused on the appropriate response to these incidents; the impact of these incidents on the Postal Service, its customers, and its stakeholders; and the economic effect on the Postal Service. The General Accounting Office (GAO) sponsored a conference on Options to Enhance Mail Security and Postal Operations, which was held December 10, 2001. Participants included representatives from Congress, the Postal Service, and many of the stakeholders (major mailers, mailer associations, postal equipment manufacturers, postal unions, management associations, and various federal agencies). 1.4 Background A brief description of the USPS mail system follows to assist the reader's understanding of the Emergency Preparedness Plan. A more detailed view of the postal system is presented in Appendix A. The mail system is primarily dedicated to the collection, distribution, and delivery of hard-copy mail items. These items are primarily letters, flats (larger than letters, yet shaped similarly, such as catalogs and periodicals), and parcels. These vary in sizes and shapes and include items as diverse as bills, payments, greeting cards, magazines, books, advertising materials, boxes, bags, and even mufflers and tailpipes. The Postal Service handled more than 210 billion pieces of mail in FY2001 - nearly 680 million pieces daily. Mail enters the system in numerous ways. There are more than 350,000 collection boxes, and nearly 40,000 Post Office lobby drops located throughout the country. Postal employees gather mail from these collection boxes on a daily basis. There are over 38,000 post offices, stations, and branches that function as retail outlets. These outlets include small country post offices, suburban post offices, major metropolitan processing centers, and postal outlets in local stores, shopping centers, and malls. At these locations, mail entry may occur over-the-counter or through retail slots. Mail may also be entered into the system at the point of delivery in 136 million locations-the mailbox on the street in front of an individual's house. This is considered "anonymous" mail because at this point the Postal Service cannot effectively associate the mail with the mailer. Commercial mailers, as compared to the individual consumer, use the mail as a tool of commerce to buy, sell, and transact business. This mail consists primarily of bills and statements, advertising mail, and periodicals. This comprises over 60 percent of the total volume of mail processed by the Postal Service. Most of this mail enters the mail stream in bulk quantities at entry points-called Business Mail Entry Units-that are dedicated to this business. Many private commercial organizations provide their own mail entry points for their customers, and subsequently enter it into the postal mail stream. These include private mail systems, and commercial mail retail establishments that cater to the general public. The Postal Service has nearly 300 processing and distribution centers that handle outgoing mail. At these centers, mail is processed and distributed from its origin to its final destination using computer-controlled electro-mechanical sorting equipment and computer data processing systems. A vast transportation network, using trucks, planes and trains moves the mail between these centers. Once mail reaches its final destination-processing center, it is sorted and distributed directly to large volume customers, Post Office Box sections for customer pickup, or to letter carriers for delivery to the final customer, ranging from large and small businesses, governmental agencies, small offices, and home offices to private homes throughout the nation. It is in this context that we must consider the complexity of the initiatives that must be undertaken to protect the mail system from bioterror. Section Two Assumptions, Methodology, and Approach 2.1 Assumptions This Emergency Preparedness Plan addresses the requirements of the House-Senate Conference bill, with the overriding goal of protecting postal employees and postal customers from exposure to biohazardous material and to safeguard the mail system from future bioterror attacks with no reduction in service to the American public. To achieve this goal, four strategic objectives are being pursued. Detect biohazardous materials introduced into the mail stream as soon as possible. Contain biohazardous materials introduced into the mail stream as soon as possible. Neutralize biohazardous agents found in the mail stream. Deter against the use of the mail as a tool for bioterrorist acts. This will be accomplished by taking action on six core technology-based and process-based initiatives: Prevention-Reduce the risk that someone could use the mail as a tool of terror. Protection and Health-Risk Reduction-Reduce risk of exposure to biohazards, and prevent cross-contamination of mail if biohazards should be introduced into the mail system. Detection and Identification-Detect and identify potential hazardous materials as early as possible in the mail stream. Intervention-As a precaution, neutralize potential contaminants in the mail. Decontamination-Eliminate known contaminants, both in the mail and in equipment and facilities. Investigation-Enhance criminal investigative infrastructure to enable more effective forensic analysis. Consistent with the conclusions of the GAO-sponsored conference of December 10, 2001, the Postal Service has determined that no single initiative will eliminate risk completely. Instead, the Postal Service must create several layers of defense against using the mail as a tool of terrorism. To ensure the greatest level of protection, the Postal Service is planning to use a multi-layered approach. It includes initiatives to prevent the introduction of biohazards into the mail system, actions to deter potential terrorists from using the mail, technologies to detect the presence of biological agents, tools and methods to reduce the health risk to employees and customers, processes to neutralize biohazardous contaminants, and investigative tools to enable a quick response to terrorist acts. 2.2 The Framework for the Analysis According to the Postal Inspection Service, there are four classes of agents that could use the postal mail system as a carrier to threaten life and economic activity in the United States: biological, chemical, explosive, and radiological. In accordance with the requirements of P.L. 107-117, this plan addresses methods and technologies primarily directed at the class of biological agents. The initiatives discussed will provide an underlying infrastructure upon which the Postal Service will build initiatives capable of addressing chemical and radiological threats. The Postal Service already has an extensive prevention and response plan for explosives in the mail. 2.3 Methodology Several teams of Postal executives, managers, and functional area experts have been investigating and evaluating strategies and exploring support technologies. Representatives from all relevant functional areas participated in these sessions. They have solicited input from government, military, industry, and mailer groups. Lab and field tests have been performed whenever possible. In many instances, ongoing reviews and evaluations are currently under way. Additionally, a Mail Security Task Force was formed immediately by the Postmaster General, CEO, John E. Potter. The ongoing Task Force is headed by Kenneth Weaver, Chief, Inspection Service, USPS. Dr. John Marburger of the Office of Science and Technology Policy hosted a number of meetings. Dr. Marburger was instrumental in bringing the scientific community together to resolve this new and complex set of challenges. At these interagency and vendor meetings and subgroups, a great many proposed technologies were reviewed and evaluated. A one-day conference was held at the National Academy of Sciences on November 14, 2001 to evaluate and assess various technologies for decontaminating mail. At this conference, the scientific community concluded that e-beam irradiation is the only valid technology meeting USPS needs at this time. A GAO-sponsored session, "Options to Improve Mail Security and Postal Operations," held on December 10, 2001, provided a forum for an exchange of ideas among Postal, governmental, industry, and mailer groups. The Postal Service continues with ongoing collaborative research and development (R&D) and evaluation efforts with the Department of Defense and the Armed Forces Radio-Biological Research Institute. 2.4 Approach The Mail Security Task Force established a focal point for developing a comprehensive plan. This task force investigated both technology-based and process-based initiatives. The seven subgroups are Safety and Security in the Workplace, Mailroom Security, Contingency Planning System-Wide, Mail Screening, Mail Preparation, Communicating and Messaging, and Mail Transportation Security. The Postal Service looked at a variety of process changes and technology initiatives that could be applied to the threat of biohazards in the mail. Careful review and consideration was given to all processes and technologies in this report. The paramount conclusion is that no single solution exists to solve the problem. It is important to note that no solution or even series of solutions can totally eliminate the threat. The conclusions and the implementation plan in this report reflect the need to put in place process changes and technology applications that can reasonably reduce risk. The objective is to reduce risk for both employees and customers of the Postal Service, while at the same time maintaining current service levels. The viability of the Postal Service and its value to the American people are dependent upon an open and accessible system. Extreme procedural changes could reduce threats, but they would also significantly damage the financial position of the Postal Service. The procedural changes included in this report reflect the balance between enhanced security and the ability of customers to do business with the Postal Service. The technology assessment in this report considered several risk factors. First, what is the state of development of the technology? In many cases, there are very interesting developments under way that remain several years from full production capability. Second, to what extent can the technology be integrated into the Postal Service operating system? Heavy emphasis was placed on the ability to maintain current service levels. Third, what is the cost of the technology? There are several approaches that simply do not provide a sufficient level of risk reduction to justify their cost. Finally, it is necessary to determine what the levels of risk reduction are. Proposals vary as to the level of protection provided and the point at which they should be deployed in our system. We concluded that there was a need to focus our efforts on a combination of procedural changes and technologies that are at or near production. However, while we continue to evaluate these system-wide applications, our first priority will be to clean, decontaminate, and reopen the Brentwood and Trenton facilities. This work was begun as part of our initial response and will continue during this next phase. At the initial operation, system-wide detection technology in processing facilities for mail picked up at collection boxes, residences, and small businesses is focused on the mail with the greatest risk. This technology, combined with enhanced security procedures for our bulk quantity mailers, provides significant risk reduction as mail enters our distribution system. In order to provide another layer of protection, we will install a vacuuming and filtration system on many of our automated sorting machines. In controlled laboratory tests, we were able to replicate the anthrax dispersion events that took place in Trenton and Brentwood. We now have a clear understanding of how a powderized biohazard escapes from the mail. Based upon this knowledge, we worked with the manufacturers of our processing equipment to design and build the vacuum/filtration systems. These systems are capable of capturing and trapping most of a biohazard as it escapes from the mail. The result is reduced risk to the postal employees operating this equipment and in turn reduction in cross-contamination that can ultimately affect our customers. We will continue to work with the manufacturers of irradiation technology. This technology remains the only scientifically accepted means of decontaminating mail exposed to biohazards. The electronic beam (e-beam) systems we purchased will be deployed in a configuration that is optimized for mail. This will allow us to accurately evaluate the operational impacts, costs, and effects on the mail and its contents. The results of this evaluation, combined with the effectiveness of the technologies described above, will dictate the appropriate next steps for irradiation technology. In addition, we continue to work with manufacturers of alternative technologies to determine whether they could be used to decontaminate mail. Beyond these first steps, we will continue to work with the manufacturers of several different technologies. Additional testing and prototyping is necessary to fully determine their viability. Key areas of focus are (1) redesign of collection box for both risk reduction and detection, (2) technology and procedures to reduce the volume of "anonymous" mail, (3) further deployment of vacuum/filtration technology on automated sorting equipment, (4) use of mass spectrometry for detection, and (5) a variety of technologies to help investigators identify the individual(s) who committed this act, as well as to deter further attempts at placing biohazards in the mail. This plan is dynamic. We will work with the Inspection Service to periodically update the threat assessment. At the same time, we will continue to evaluate a variety of technologies as they reach maturity. We also are committed to working with research and development efforts as new approaches are developed to address this problem. 2.5 Results The Postal Service used the many ideas and possible approaches gathered through these forums and investigations to put together the optimum mix of methods and technologies to reduce the probability of using the mail as a tool for biologic attacks, to minimize the health risk of any future attack if there were to be one, and to be prepared with a quick response strategy to contain any negative side effects. The Postal Service used Mitretek Systems to finalize, review, and evaluate the plan for completeness and efficacy. Mitretek, a nonprofit research and development corporation supporting federal government agencies, has extensive experience with chemical and biological materials, as well as with Postal Service operations. This plan provides for both the process changes and technology applications necessary to ensure the enhanced safety of both postal employees and postal customers. The emphasis is placed on prevention, detection, and risk reduction at the earliest point feasible in our distribution network. The combination of process change and an array of technology applications across prevention, detection, and risk reduction provides maximum protection for employees and customers. Section Three Survey of Available Strategies and Technologies to Meet Biologic Threats There are six initiatives where specific actions may be taken to reduce the risk of introducing biohazards into the mail stream or to mitigate the potential effects of such an event: prevention, protection and health-risk reduction, detection and identification (of biohazards), intervention (and sanitization), decontamination (mail, equipment, and facilities), and investigation (support for criminal prosecutions). This section presents a brief overview of the major process-based and technology-based projects that were proposed and initially evaluated for the six initiatives. (Detailed information regarding these projects is provided in the appendices.) 3.1 Prevention At Entry Points On the Streets-Reduce risk of exposure through collection box redesign, detection, containment and decontamination; and enable mail tracking at the batch level to the collection box. At the Retail Outlet-Reduce anonymous mailing by associating individual retail transactions with uniquely identified postal products; reduce the risk of exposure through detection, containment, and decontamination. At Business Entry Points-Reduce risk by implementing security standards at commercial mailers' facilities. Via Access Control Enhance security at truck entrances at postal facilities. 3.2 Protection and Health-Risk Reduction Protect employees from exposure through improved housekeeping procedures, use of protective wear, use of filtered vacuum systems, integrated filtered vacuum systems on mail processing equipment, and upgraded air-handling and heating, ventilation, and air-conditioning (HVAC) filtering systems. 3.3 Detection and Identification Triggering Provide continuous, unattended monitoring, with rapid reporting of the existence of potential threats. Confirmation Positively verify the presence of biohazardous agents. 3.4 Intervention-Precautionary Mail Sanitization Eliminate risk of exposure by destroying microbial organisms that may be present in the mail. 3.5 Decontamination Mail Decontamination Eliminate risk of exposure by destroying microbial organisms known to have contaminated the mail. Facility and Equipment Decontamination Eliminate risk of exposure by destroying microbial organisms known to have contaminated facilities and equipment. 3.6 Investigation Deter use of mail as a tool of terror by increasing effectiveness of forensic investigation through image capture and analysis, mailpiece tracking and tracing, and positive product tracking. 3.7 Technologies and Processes Under Considerations The specific technologies and processes considered and investigated by the Postal Service are presented and briefly described below. Detailed information on these technologies and processes may be found in the appendices. 3.7.1 Prevention At Entry Points On the Streets Name Description Collection Box Containment Detection Decontamination Tracking Redesign collection box to contain mail in a separate box or containment bag. Use biohazard detection strips in collection box. As a precaution, use sealed polyethylene bags in collection boxes and a decontaminating agent. Modify existing system to track unit loads in collection boxes using Delivery Confirmation scanner. At the Retail Outlet Name Description Transaction Recording Integrate retail and video systems by using unique identifying product codes to match customers with purchases and mailing. Intelligent Mail Use information currently on, or placed on, a mailpiece to identify sender, intended recipient, and process location. Drop Box Pathogen Detection Use detection devices inside USPS facilities to detect biological hazards in collection mail drop slots. At Bulk Entry Points Name Description Security Process for Commercial Mailers Expand security procedures and standards to ensure safety of manufactured mail. Via Access Control Name Description Access Control of Vehicles and Individuals at Truck Entrances of Postal Facilities Use access control devices at truck/business entrances. 3.7.2 Protection and Health-Risk Reduction Name Description Permanent Vacuum Filtration Systems on Processing Equipment Install permanent vacuum (ventilation) systems on mail-processing equipment to automatically and continuously vacuum, and to extract and capture particulate matter. Filtration Systems in HVAC Upgrade the efficiency of filter media used in ordinary HVAC systems. Consider ultraviolet light, ultrasonics, or anti-microbials. High-Efficiency Particulate Air (HEPA) Cleaning Systems Use filtered vacuums to clean mail-processing equipment or building surfaces. Custodial Cleaning Use rider and walk-behind power scrubbers, for use with chlorine bleach. Protective Wear Equip workers with protective gloves and masks and provide training on how to use these items. 3.7.3 Detection and Identification Triggering Name Description Particle Counter Continuously collect air from a specified point in the mail stream where a biohazardous plume is most likely to occur. Compare the profile of the size and amount of particulate with known biohazards. Particulate Shape Analyzer Measure shape and size of every particle in the 2?20 micron range from the air continuously collected from a specified point in the mail stream. Compare to profiles of known biohazardous agents. Laser Discriminator Collect particles amassed from a continuous air stream within a defined size range; fluoresce with laser to determine whether signature matches biohazardous material signatures. Confirmation Name Description Biological Indicator Strip Use strip(s) with indicator agent(s) that react(s) to compounds found in the biothreat. Immunoassay Test Strip Introduce liquid sample of target substance onto a test strip. Strip indicates the positive presence of a biohazard. Polymerase Chain Reaction (PCR) Introduce liquid sample into a self-contained cartridge that determines presence of a biohazard. Mass Spectrometer Use electric and magnetic fields to precisely measure the mass of the charged particles. Match mass spectrum of a sample against a library of known substances. 3.7.4 Intervention Mail Sanitization Name Description Irradiation-Ionizing Radiation Electron Beam X Ray Gamma Ray Irradiate mail with electrons, X-rays, or gamma rays to break chemical bonds and damage deoxyribonucleic acid (DNA) of bacteria. The bacteria's ability to reproduce and spread infection is destroyed. Irradiation-Non-ionizing Radiation Ultraviolet (UV) Light Microwave Use UV radiation to kill microorganisms by damaging DNA resulting in cell death. Use microwave radiation to heat and kill microorganisms. Gas Plasmas Use plasma generators to produce high-temperature, reactive material. Technology limited to facility/equipment decontamination; not a viable option for mail. Ultra-High-Pressure (UHP) Sterilization Use UHP to inactivate microorganisms by physically changing protein and nucleic acid structure. Gaseous Treatment Chlorine Dioxide Ethylene Oxide Methyl Bromide Ozone Use gases with anti-microbial properties to kill potential biohazardous materials. 3.7.5 Decontamination Mail Decontamination Name Description Irradiation-Ionizing Radiation Electron Beam X Ray Gamma Ray Irradiate mail with electrons, X-rays, or gamma rays to break chemical bonds and damage DNA of bacteria. The bacteria's ability to reproduce and spread infection is destroyed. Mail Decontamination (Continued) Name Description Irradiation-Non-ionizing Radiation Ultraviolet (UV) Light Microwave Use UV radiation to kill microorganisms by damaging DNA, resulting in cell death. Use microwave radiation to heat and kill microorganisms. Gas Plasmas Use plasma generators to produce high-temperature, reactive material. Technology limited to facility/equipment decontamination; not a viable option for mail. Ultra-High-Pressure (UHP) Sterilization Use UHP to inactivate microorganisms by physically changing protein and nucleic acid structure. Gaseous Treatment Chlorine Dioxide Ethylene Oxide Methyl Bromide Ozone Use gases with anti-microbial properties to kill potential biohazardous materials Facility and Equipment Decontamination Name Description Gaseous Treatment Chlorine Dioxide Ethylene Oxide Methyl Bromide Ozone Use gases with anti-microbial properties to kill biohazardous materials. Paraformaldehyde powder Use fumigant to permeate space and kill viable microbial forms of life. 3.7.6 Investigation Image Capture and Analysis Name Description Image Capture and Analysis Collect, save, and analyze images captured by existing mail recognition equipment. Wide Field of View (WFOV) Image Capture Install WFOV cameras to capture complete mail images for recognition processes. Mailpiece Tracking and Tracing Print additional tracking information on mail by using two-dimensional bar codes applied to mailpieces. Use WFOV cameras to read the additional information. Positive Product Tracking Uniquely identify and track all retail mail and mail products presented at USPS retail outlets. Section Four Analysis 4.1 Scope and Approach The scope of this analysis encompasses the technologies and methods identified in Section 3, as applied in six core initiatives (see Section 2.1). The information supporting this analysis is found in Appendices B through G and reflects the efforts of the Postal Service teams and task forces identified in Section 2. The approach to this analysis is to first conduct a qualitative assessment of programmatic risk based upon technical, operational, and cost risk factors for individual technologies and processes. For applications where multiple candidate technologies have been proposed, the technologies are ranked against each other based on their relative risk. Technologies and methods found to have acceptable risk levels are then evaluated on their abilities to implement the overall Postal Service strategy articulated in Section Two and the plan described in Section Six. 4.2 Qualitative Risk Assessment The purpose of the qualitative risk assessments is to assess the viability of the candidate technologies to determine if they should be included within a core initiative within the postal environment. These core initiatives are Prevention, Protection and Health-Risk Reduction, Detection and Identification, Intervention, Decontamination, and Investigation (see Section 2.1 for further details). The viability of a technology is assessed in terms of the technical, operational, and cost risk associated with a proposed application. Technical risk includes consideration of the following factors: Maturity in terms of current commercial availability or development status (e.g., concept development, prototype) Effectiveness in comparable applications and environments Dependence upon supporting technologies Operational risk is closely allied to technical risk and includes consideration of the following factors: Training and support requirements Impact on postal workflows Regulatory (e.g., environmental) considerations Acceptance in the workplace Cost risk factors include the following: Confidence in the accuracy and precision of direct and life-cycle cost estimates (low risk implies high confidence in the quality of the cost estimate, not that the actual cost is low). The magnitude of the application cost relative to the benefit of spending additional dollars in another area. Table 4-1 maps these risk factors to specific topic areas discussed in the following analysis and detailed in the appendices. It also documents the relationship between the risk analysis and the determination of each application's viability. This analysis is a qualitative risk assessment based on currently available information. The information for each technology or process change was evaluated to determine an ordinal scale risk value for each risk factor considered. These ordinal scale values are presented below: Low Risk-Few if any obstacles have been identified other than standard deployment issues, and none are considered to be serious. Moderate Risk-Some obstacles are present and known, but none are considered serious enough to jeopardize deployment. Further development and testing are required. High Risk-One or more obstacles exist that either require significant effort to address or have a high degree of uncertainty pertaining to cost or operational impacts. Unacceptable Risk-This technology is not considered a viable option due to one or more significant hazards. The values for applicable risk factors are combined to form a risk-scale value (Low, Moderate, High) for each of the three risk areas (Technical, Operational, and Cost). Professional judgment is used to determine the overall risk-scale values. Where risk factors vary within a risk area, a risk-scale value range may be assigned (e.g., Low to Moderate Risk). Likewise, in the case where a risk-scale value of High is assigned to an important risk factor, an overall risk area value of High may be assigned. As a final step, a determination of the viability of the technology is made based on the Technical Risk, Operational Risk, and Cost Risk values. Viability for a proposed Postal Service application will be assigned as follows: Immediate-already completed. Near-Term Viability-potentially deployable within 1 year, based on available information. Intermediate-Term Viability-potentially deployable within 2-3 years, based on available information. Long-Term Viability-potentially deployable within 4-5 years, based on available information. Not Viable-technology has one or more major drawbacks or insufficient information is available to make a valid judgment. A summary of the resulting technology and process viability assessment is presented in Table 4?1. Figure 4-1. Risk Factor Map Table 4-1. Summary of Technology and Process Viability Initiative/Technology Risk Viability Comments Technical Operational Cost Prevention · Collection Box: Redesign Moderate-High Low-Moderate Moderate Intermediate- to Long-Term Requires development of an automated bag closing mechanism that will not interfere with customer mail deposit. · Collection Box: Detection Moderate Moderate Low Intermediate-Term Extensive testing required for the detection strips. · Collection Box: Decontamination Moderate High Moderate Long-Term, possibly Not Viable Possible leakage of decontaminate pose a threat to postal patrons and employees. · Retail Security Initiative-Positive Product Tracking System Low-Moderate Moderate-High Low Intermediate-Term Requires development of technology to provide near universal encoding of retail merchandise in an acceptable manner. Requires implementation in a large number of sites. · Security Process for Commercial Mailers Low Moderate-High Moderate Near- to Intermediate-Term Requires commercial mailers to implement and maintain security that is compliant with Postal Service standards. · Access Control at Truck Entrances Low Low Low Near-Term No issues. Protection and Health-Risk Reduction · Filtration Vacuum Systems on Processing Equipment Low Low Low Intermediate-Term Established technology, some design work required. · HVAC System Filtration or Modification Not Applicable Not Applicable Low Immediate Feasibility study only, prototyping may result based on study findings. · HEPA Cleaning Systems Low Low Not Applicable Immediate Vacuums have been purchased. Detection · Biological Indicator Strip Moderate Low Low Near- to Intermediate-Term This technology is just becoming available. These strips must be used in conjunction with a confirmation technology. · Particle Counter Moderate-High Low-Moderate Low-Moderate Intermediate-Term A high particulate background within the postal processing environment may affect this technology. · Particulate Shape Analyzer High Low-Moderate Low-Moderate Intermediate-Term A high particulate background within the postal processing environment may affect this technology. · Laser Discriminator High High High Intermediate -Term A high particulate background within the postal processing environment may affect this technology. · Immunoassay Test Strip High Low Low Near- to Intermediate-Term There may be insufficient sensitivity for some applications. · Polymerase Chain Reaction (PCR) Low-Moderate Low Low Near- to Intermediate-Term Established technology must be tested in an operational postal environment. · Mass Spectrometer Moderate-High Low-Moderate Moderate Intermediate A high particulate background within the postal processing environment may affect this technology. Table 4-1. (Concluded) Initiative/Technology Risk Viability Comments Technical Operational Cost Intervention · Electron Beam Low-Moderate Low-Moderate Low Near- to Intermediate-Term Currently in use for mail irradiation; continued studies on effects to mail and its contents · X Ray Moderate-High Moderate Not Applicable Long-Term Technology has not been demonstrated for high throughput. · Gamma Ray Moderate-High Unacceptable Not Applicable Not Viable Unacceptable due to introduction of radioactive materials into postal operations. · Ultraviolet Light Irradiation Unacceptable Not Applicable Not Applicable Not Viable Provides surface sterilization only. · Microwave Irradiation High Low-Moderate Insufficient Information Not Viable Provides non-uniform sterilization. · Ultra-High-Pressure Sterilization High Insufficient information Insufficient Information Insufficient Information This technology is not currently commercially available. · Sterilization by Gaseous Treatment Methods Unacceptable Not Applicable Not Applicable Not Viable Technologies have not demonstrated the ability to kill biohazards that may be present in an effectively sealed envelope. Decontamination (Facility) · Chlorine Dioxide Low Low-Moderate Low Near-Term Has been used in the Hart Senate Office Building. · Ethylene Oxide Moderate-High Moderate-High Insufficient Information Intermediate- to Long-Term Lack of previous use as a facility decontaminant. · Methyl Bromide Unacceptable Not Applicable Not Applicable Not Viable Lack of availability beyond 2006. · Ozone Moderate-High Moderate-High High Not Viable Not demonstrated to be effective, plus possible damage to postal equipment. · Paraformaldehyde Low-Moderate High Insufficient Information Not Viable Identified as a carcinogen. Investigation · Image Capture and Analysis Low - High Low - Moderate Low Intermediate-Term Risk varies by project phase. · Wide Field of View Image Camera Low Low Low Near- to Intermediate-Term Systems will need to read mail at a high rate of speed in order not to degrade workflow. · Mailpiece Tracking and Tracing Low Low-Moderate Low Intermediate-Term Depends upon successful implementation of the wide field of view camera. 4.2.1 Prevention Four technologies/procedures that provide capabilities for preventing contaminated mail from entering the mail processing system have been identified for further evaluation: Collection Box Retail Security Initiative Security Process for Larger Mailers Access Control at Truck Entrances Each technology/procedure provides a different facet in providing prevention protection in the Postal Service's mail processing environment. Each is a viable candidate that could prevent contamination of mail. Each candidate technology/procedure can be used independently of the other candidates and can also be used concurrently with other candidate technologies. Additional information on each of these technologies is included in Appendix B. 4.2.1.1 Collection Box Description The overall risk for this technology is moderate-high since the three enhancements listed below have not been developed, implemented, or tested in a Postal Service environment. This candidate technology comprises three potential enhancements to the collection box: Redesign of the collection box to keep all of the mail dropped into the box in a single bag/tub or other container that can be closed before the mail is removed from the box. Use of detection strips to detect contamination of mail while it is still isolated in a collection bag/tub or other container. Decontaminating the mail while still in a sealed collection bag/tub or other container. Some combination of these technologies could be implemented in collection boxes to prevent the introduction of contaminated mail into the mail-processing system. The risk for each sub-technology/procedure is evaluated below. The cumulative risk for collection box technologies has also been determined. The impact of increased protection of the mail by reducing the number of collection boxes available to the public has been evaluated. The Postal Service has determined that reducing the number of collection boxes will have a minimal impact on preventing contaminated mail from entering the system. A terrorist intending to use the mail to spread biohazardous contaminants will find a collection box to use. However, the trade-off analysis indicates that reducing the number of collection boxes would have a negative impact on the level of service provided to Postal Service customers. Even a one-third reduction in the number of collection boxes on the street would result in a minimal reduction in the level of risk for biohazard contamination since two thirds of the boxes would still be available to a potential terrorist. However, that level of reduction in the number of street collection boxes would have a significant negative impact on customer convenience. Completely removing collection boxes from the street would totally undermine the economic viability of the Postal Service. Additional information about the impacts of reducing the number of collection boxes is included in Appendix H. Technical Risk No collection box is commercially available that meets the requirements of isolating hazardous materials yet allows the safe deposit of mail. The technical risk is in the development of an automated bag/tub closing mechanism that can be installed without interfering with the customer's ability to deposit mail in the collection box. It is dependent on mechanical technologies that could be modifications of existing mechanisms. Such a collection box would need to be designed and tested; the technical risk here is judged to be moderate to high. The technical risk for collection-box detection is moderate at the time this evaluation was produced. The Postal Service has recently received samples of the detection strips that would be used for this solution and has not had the opportunity to complete testing and evaluation. Decontamination bag technology has been developed and could be implemented within the Postal Service but only after extensive testing. The technical risk for this capability is judged to be moderate. Operational Risk Operational impacts deriving from the collection box re-design present low to moderate risk. A manual closing mechanism introduces an additional responsibility on the collector, and there will be an operational impact on the amount of time it takes the collector to collect the mail and install a new collection bag/tub. An automated bag/tub closing capability would introduce additional operational risks, as the closing mechanism would require maintenance levels in excess of that required for current collection boxes, and is vulnerable to temperature extremes, moisture, and substances that may be introduced into the box. If the automated closing mechanism becomes inoperable when the collector attempts to collect the mail, the collector will be at increased risk. The overall operational risk level of in-box detection is moderate but will require that adequate training initiatives for collection personnel be developed. The in-bag/tub (or other) technology would use a detection strip that is an integral part of the collection container. The operational risks are derived from (1) bag/tub handling by the mail collector and (2) storage and maintenance of the bags/tubs prior to installation in a collection box. The operational risks for in-box decontamination are judged to be high. If the decontamination gases are included as part of the collection container, then there is a moderate to high possibility that the gases could escape from the collection box and threaten a customer. If the bags/tubs are returned to a delivery unit for decontamination, there is lower risk to the customer but potentially higher risk to employees. There are also regulatory risks and the risk of possible resistance from the employees working at the delivery unit. Cost Risk The cost risk for collection box redesign is moderate. The initial cost estimate for the redesign of collection boxes is $1,000 per box. Based on that initial estimate the projected cost for all collection boxes will be $352 million; however, since such boxes have not yet been developed, this projected cost is still just an estimate. Further, the large number of such boxes significantly magnifies the cost risk for this technology. Other technologies discussed in this report could provide equal or better protection for lower cost. The overall cost risk for detection strips is low. The cost has been estimated at less than $1.00 for biological indicator strips. Bulk purchase of strips in the required quantities may lower the cost per strip. The direct cost risk is moderate for collection box decontamination. Decontamination gases are available commercially although the Postal Service may need to have the gases generated at the decontamination site. The cost for containment bags that include the decontamination gases is $0.50 per bag. The projected cost for collection boxes and drop slots using these bags is $61 million annually. This cost may not reflect the total cost of using this technology. Viability The viability of collection box redesign is Intermediate- to Long-Term. This effort must start at the conceptual stage and move through development. The viability of collection box detection is Intermediate-Term. Available technologies require further testing and possible development. The viability of collection box decontamination is Long-Term to Not Viable. The routine use of decontamination technology for all Postal Service collection boxes may not be feasible. 4.2.1.2 Retail Security Initiative Description The Retail Security Initiative is a combination of technologies that will enable the Postal Service to match retail merchandise with retail customers. The initiative will be accomplished with the development of a positive product system. This positive product tracking system would combine video images of customers with recorded time and date data, plus encoded data that identifies items purchased by the customer or delivered by the customer for mailing. All data will be collected and stored at the retail unit. If required, the data will be available to support subsequent investigations. Technical Risk The technical risk is low-moderate. The positive product system will be developed using existing POS ONE terminals and installed video technologies and equipment. An unknown risk factor, at this time, is the development of a technology to provide near-universal encoding of retail merchandise in a manner that is acceptable to the Postal Service's customers. Operational Risk The operational risk is moderate for the technology but high for actual implementation since there are a large number of facilities that do not have the required existing technologies. Therefore, the overall risk is moderate-high. For sites with existing technologies, the operational impacts will be minimal. Storage technologies required to support large quantities of video and identification data would be evaluated as part of the positive product tracking development effort. There will be minimal operational impacts on postal employees and on the workflow in the retail unit. Workplace acceptance is not expected to be an issue. Cost Risk The cost risk is low. The projected costs, $250 million, are significant because of the large number of retail units that must be upgraded. The average cost per site is under $17,000. The Postal Service can minimize the financial impacts with phased implementation of the initiative. Viability The retail security initiative is Intermediate-Term in viability because additional technology is necessary to complement existing low-risk technology. 4.2.1.3 Security Process for Commercial Mailers Description The Postal Service will work with commercial mailers to develop a set of security standards that the larger mailers can implement in their facilities. These security standards will provide the commercial mailers with security capabilities to reduce the risk that mail can be contaminated before it is delivered to the Postal Service. The Postal Service expects to receive mail from these commercial mailers that has been protected from possible tampering or contamination. When commercial mailers comply with Postal Service security standards, the Postal Service will consider that the mail is "safe," e.g., it has not been exposed to possible contaminations. The Postal Service will accept and process this "safe" mail without submitting it for detection and possible decontamination processing. Technical Risk The technical risk is low. The security standards will be based on established procedures and the use of established security technologies. The security standards, when implemented, will effectively control access to mail before it is shipped to the Postal Service. Additionally, there are no technology dependencies. The primary issues that will have to be addressed are business impact and operational risks. Operational Risk There is a moderate-high level of operational risk since the commercial mailers may be reluctant to modify their in-house security operations. The Postal Service will be dependent on the commercial mailers to implement and maintain security that is compliant with jointly developed security standards. The commercial mailers will need to train their employees to comply with security standards. The security standards may impact the workflow at the commercial mailers' facilities and may, therefore, become impediments that the commercial mailers must overcome. Operational problems at a commercial mailer's workplace puts the Postal Service at risk since the Postal Service must retain its customer base and still receive and process the customer's mail. Cost Risk The cost risk for the Postal Service is moderate. The cost to develop the security standards should be low since security standards would be based on existing standards (both USPS and other government agencies). The Postal Service will increase staff levels to monitor compliance by commercial mailers. Viability The viability of a security process for large mailers is Near- to Intermediate-Term. Although Technical and Cost risks are low, customer concerns elevate the operational risk to a moderate level. 4.2.1.4 Access Control at Truck Entrances Description The Postal Service will undertake an initiative to increase the security at its large mail-processing facilities. The objective of this effort is to increase controls on access to postal facilities through truck entrances. The Postal Service will accomplish this objective by upgrading and installing additional electronic and mechanical security features. The Postal Service will also install badge/card readers and will increase the number of personnel at the truck entrances. Technical Risk The technical risk is low. Security enhancements at facility entrances will use commercially available components that are widely used. The Postal Service plans to leverage efforts by government agencies and commercial organizations to achieve comprehensive security coverage with minimal costs. Operational Risk The operational risk is very low. There should be no impacts on workflow. The technologies are standard and should not produce regulatory concerns. Training and support requirements are minimal. Cost Risk The cost risk is low. The projected cost for equipment and systems development is $64 million. The average cost of $160,000 for each of the 400 sites is reasonable and consistent with the proposed technologies. The projected staff cost, $70 million, is reasonable when the intent is to fully staff facility entrances. The benefits to the Postal Service are projected to be substantial. The Postal Service will protect its facilities and equipment and will provide employees with increased confidence that their workplace is safe. Viability The access control for vehicles at truck entrances is viable in the Near-Term through the use of readily available and mature technologies. 4.2.2 Protection and Health-Risk Reduction Three technologies have been identified as potentially applicable for health-risk reduction in postal facility applications: (1) installation of filtration vacuuming systems on processing equipment, (2) installation of higher efficiency filtration systems or application of control technologies within HVAC systems, and (3) use of HEPA vacuuming systems for cleaning mail-processing equipment and building surfaces. These are three distinct applications with one candidate technology for each application. A qualitative risk assessment follows for each technology application, based on information found in Appendix C. Since there are no identified competing technologies within an application area, no comparative analysis has been performed to supplement the individual risk assessments. 4.2.2.1 Filtration Vacuum Systems on Processing Equipment Description This candidate technology entails the design and installation of air-cleaning systems on existing mail-processing equipment to reduce the potential risk of employee exposure to airborne hazards. This technology would automatically and continuously vacuum letter-processing equipment to minimize the risk of airborne biohazards in processing facilities. The use of pre-filters and HEPA filters in these air-cleaning systems should minimize paper dust and possible airborne hazards by several orders of magnitude. Technical Risk Engineering and development teams are currently testing prototype systems for Culling "010" systems, for the Delivery Bar Code Sorter (DBCS) and the Automated Flats Sorting Machine (AFSM 100) in an operational environment. The experience gained from these efforts will then be applied in the design of systems for other postal equipment. The collection systems must be designed for each equipment type, including fabrication of hoods and shrouds for previously open equipment, including conveyor systems; experience gained in early efforts will be applied to other equipment. The technology maturity/development risk is considered low. Equipment such as the Advanced Facer Canceler System (AFCS), AFSM 100, and the DBCS, are generally a standard configuration. This standardization and commonality of equipment facilitates the deployment of vacuuming and filtration modifications. The application of a multi-stage vacuum filtration capability, including HEPA filtration, has been shown to be 99.7 percent efficient at the 0.3-micron particle size and is thus considered to be a proven and effective technology. This technology has been widely applied in bio-safety facilities and other locations where maximum state-of-the-art sub-micron particulate material removal is required. The technical risk regarding application as proposed in the postal environment is considered to be low. The overall technical risk, based on the factors discussed above, is considered low. There are no other overriding technical considerations. Operational Risk Engineering designs will include consideration of possible operational impacts that may include increased energy consumption, decreased machine availability, increased heat load on HVAC systems, loss of floor space, decreased accessibility for open systems due to installation of hoods and shrouds, and the need to maintain the filtration systems. Additional training and support requirements-as well as the workflow impacts-are considered acceptable risk issues, or they can be subject to risk mitigation. The operational risk associated with these factors is considered to be low. No regulatory or environmental issues are believed to exist beyond the handling and disposal of potentially contaminated filters, for which standard procedures exist. Consequently, operational risk from environmental factors is considered low. As a final concern, workplace acceptance is not considered to be an issue. The potential health benefits outweigh the training, support and workflow impacts identified above. Based on the above, the overall operational risk is considered to be low. Cost Risk The rough-order-of-magnitude costs used in the analysis are representative of preliminary estimates provided by the equipment manufacturers. Testing efforts scheduled for January-May 2002 will provide a basis for validating or revising the unit production and support costs. The near-term availability of this cost data supports assignment of a low risk value for these factors. Installation of continuous vacuum filtration systems on 1,100 AFCS and 1,800 outgoing DBCS machines is estimated to cost $145 million. The Postal Service's intent is to conduct a phased deployment based on funding, and deployment is aimed at the most vulnerable areas first. Overall cost risk is considered to be low. Viability This technology has potential Intermediate-Term viability for the Postal Service. Based on the technical, operational, and cost risk factors, the efforts to develop and deploy filtration vacuum systems on postal facility processing equipment will be continued. Trade-off studies will be conducted to prioritize the equipment purchases so that the benefits for postal employees and customers are maximized. 4.2.2.2 HVAC System Filtration or Modification Description This project would investigate the potential use of high-efficiency air filtration and decontamination technologies in postal facility HVAC systems. The purpose of this study would be to determine the feasibility of such technologies, leading to possible prototyping. Technical Risk The analysis of technical risk is not directly applicable to this project as the study purpose is to determine the feasibility-and thus identify the technical and operational risks-of using these filtration and decontamination technologies in typical postal facilities. The candidate technologies are presumed to be commercially available. The only technical risk factors to consider are the study design itself and the validity of extending study results to other, non-study postal facilities. Based on the above, a technical risk value is not assigned. Operational Risk Since the scope of this investigation is limited to a small-scale study and not to the full-scale deployment of specific technologies, no operational impacts have been identified. Based on the absence of operational impacts, no operational risk is assigned. Cost Risk The Postal Service has received a firm proposal of $135,000 for this study. Cost risk is therefore assumed to be low. The cost of this feasibility study is relatively small in comparison to other technology proposals considered here. The results of this study will be used to develop better cost estimates. Based on the above, cost risk is considered to be low. Viability The relative low cost and limited scope of this feasibility study make it a viable first step as part of an effort to develop information to further assess these candidate technologies within the postal system. Effectively, viability is assigned an Immediate level. 4.2.2.3 HEPA Cleaning Systems Description Postal Service Headquarters is acquiring and deploying approximately 16,000 HEPA-filtered vacuums for facilities that have more than 5,000 square feet of space. These vacuums will be used for cleaning equipment and building surfaces within the postal facilities. This is an ongoing initiative that is scheduled for completion in March 2002. These vacuums will be used to implement new cleaning practices (vacuuming and wet methods). Technical Risk These vacuums are commercial off-the-shelf products and have been procured based on Postal Service specifications. As of the end of January, over 9,000 of these vacuums have been delivered to postal facilities. Final deployment of all vacuums is expected by the end of March 2002. Postal Service Engineering is continuing to review additional equipment. Given that these are standard commercially available products and have been procured in accordance with a Postal Service specification, low technical risk is assumed. Operational Risk Potential operational impacts include a possible increase in the time and labor needed to clean postal equipment, compared to previous practices of dry sweeping and the use of compressed air. These impacts are considered acceptable and require little additional training or support. There are some initial concerns that these new processes are not cleaning DBCS systems as thoroughly as the previous "blow and go" procedures and the machines could clog. There are no known regulatory or environmental issues governing the use of these vacuums. Workplace acceptance is assumed to be high since lower noise levels will result from the use of these vacuums. Furthermore, vacuuming should result in a potentially cleaner work environment than existed when using the previous cleaning practices of dry sweeping and air blowing since these procedures reduce airborne particulates. Based on the above, a low operational risk level has been assigned. Cost Risk The cost of this acquisition has been approximately $12.6 million and for practical purposes is completed. Therefore, no cost risk is assumed. Viability Since this technology is already used in postal environments for equipment and building surface cleaning, viability is assigned an Immediate level. Additional vacuums may be acquired if local funds are available. 4.2.3 Detection and Identification Detection technologies presently under consideration fall into three somewhat overlapping categories: triggering technologies, confirmation technologies (biohazard signature testing), and combined triggering and confirmation technologies. The three air-monitoring technologies are candidates for triggering technologies, while the integrated polymerase chain reaction (PCR) assay system and immunoassay test strip are possible confirmation technologies. Note that PCR may be coupled to an automatic air sampler to provide periodic air monitoring and automated confirmation. An air particulate concentrator interfaced to a mass spectrometer is a possible triggering and confirmation technology in the same unit. The indicator strips could also be placed in an air concentrator, but would require further confirmation testing. All of the triggering technologies within the first category must be used in conjunction with a confirmation technology within the second category. In addition, only the biological indicator strip is a possible candidate for use in environments other than processing and distribution centers. All other technologies would be deployed within postal facilities. Additional information on each technology is found in Appendix D. Technology R&D efforts continue to produce new viable technologies that the Postal Service will evaluate for future, expanded facility monitoring. 4.2.3.1 Biological Indicator Strip Description The Biological Indicator Strip is a piece of paper impregnated with indicator reagent(s) that react with compounds found in the bio-threat to produce a color change. The strip being considered has reagents that will react with a compound found in bacteria of the genus Bacillus and several others. The technology was initially conceived for bacterial testing in the food industry. Its potential application as part of the Postal Service approach to biohazard threats is for bacterial testing of surfaces or other samples at almost any point in the mail-processing system. Its simplicity and low cost make it potentially deployable at collection boxes (see Section 4.2.1.1). Technical Risk The indicator strip technology is becoming commercially available and was initially conceived to be used in the food production industry. The indicator strip does not specifically identify anthrax or any other biohazard and would require use of a complementary confirmation technology. One area of concern is the sensitivity level of the indicator strip. If a large quantity of biohazard is needed to obtain a positive test result, the potential applicability of the technology in the postal environment could be limited. Detection of airborne spores may require an aerosol collector front end. Based on the above, a moderate technical risk level is assigned to this technology. Operational Risk The indicator strip should have little or no impact upon postal operations beyond establishing training and support in its use. There are no regulatory or environmental issues beyond the disposal of used test strips. Workplace acceptance should be high, assuming that the technology proves to be effective and neither results in too many false positives or false negatives, the latter caused by a lack of sensitivity. Given the above, a low operational risk level is assigned to this technology. Cost Risk The indicator strips are estimated to cost less than $1 per strip. Support costs are also presumed to be low. Therefore, a low cost risk is assigned to this technology. Viability The indicator strip can potentially help the Postal Service rapidly identify contamination with certain biohazards wherever it may occur in the mail-processing system. In particular, the relatively low cost of the indicator strip may allow for monitoring at the earliest point in the process-the mailbox-and/or on personnel identification badges. Its value to USPS will ultimately depend on its sensitivity. A relatively low sensitivity test will only give a positive result when a large amount of contamination is present. In addition, the need for sampling by air filtration must be evaluated. Consequently, the indicator strip technology appears to have Near- to Intermediate-Term viability subject to further testing to determine its sensitivity. Note that this technology must be used in conjunction with a confirmation technology in order to provide effective detection of biohazards. 4.2.3.2 Particle Counter Description The particle counter is considered a possible triggering technology. This technology continuously compares the size distribution of particulates present in the air stream at a given point in time with that observed over the preceding few seconds. If a biohazardous particulate is introduced in the mail stream, a reading of the profile of both size and amount of particulate will be recognized as outside of a normal profile. Typically used in laboratories and industrial settings, it could be inserted into the mail processing system at points where mechanical forces are likely to cause release of substantial amounts of spores from a piece of mail. Technical Risk Particle counters are widely available as commercial off-the-shelf items that are typically used in laboratories and industrial settings where airborne particles pose a risk to human health and/or product quality. This technology, or variants of it, is available from multiple vendors, can be installed or portable, can be set to specific particle size ranges, and can be calibrated using National Institute of Standards and Technology standards. Vendors can supply certification and performance measures data. Of principal concern is this technology's effectiveness in the postal processing environment, where there may be a high background level of particulates. It remains to be determined whether a particulate counter/sizer can effectively identify bacterial spores or other kinds of bioterror threats against a high background. A second concern is that dry bacterial spores, even the type used in the anthrax letters, have a wide range of particle sizes, suggesting that particle size distribution is not a very good criterion for identifying the presence of biological contamination. Based on the above, a moderate to high technical risk level is assigned to this technology. Operational Risk The use of particle counters on processing and distribution center equipment such as the AFCS would not require retrofitting that might impact equipment functioning or serviceability. Since the technology is currently in use in other industrial settings, this is not a major concern. Operation of the particle counters would require specialized user training and support, but this is not seen as a determining factor. Maintenance requirements are not known at this time. No environmental or regulatory issues have been identified, and workplace acceptance should not be an issue. Based on the above, a low to moderate operational risk level is assigned to this technology. Cost Risk Capital costs are estimated at $5,000 per unit. Assuming 2,000 units required at major processing and distribution centers, the total cost could be $10 million. Other operational and maintenance costs are not known. Cost risk is assessed to be low to moderate. Viability The viability of this technology hinges on its ability to identify bacterial spores or other kinds of bioterrorism threats (from a single contaminated letter) against a high background such as is found in the postal processing and distribution center environment. It has not been proven that particle size distribution is an effective criterion to identify the presence of biological contamination. Additional modification may be required to improve the capabilities of this technology. Consequently, this technology appears to have Intermediate-Term viability subject to successful testing. As in the case of other triggering technologies, the particle counter must be used in conjunction with a confirmation technology in order to provide effective detection of biohazards. 4.2.3.3 Particulate Shape Analyzer Description The particulate shape analyzer is a device that counts and images airborne particles. It measures the shape and size of every particle in the 2-20 micron range from an air stream continuously collected at a specific location. The resulting profile is then compared to established profiles of shape/size combinations for a match with other biohazardous agents. If a biohazardous particulate is introduced in the air stream, a reading of the profile of both size and amount of particulate will be recognized as outside of a normal profile. Typically used in laboratories and industrial settings, it has primarily found applications in Europe. It could be inserted into the mail-processing system at points where mechanical forces are likely to cause release of substantial amounts of spores from a piece of mail. Technical Risk Particulate shape analyzers are commercial off-the-shelf items from a small number of vendors. This device is designed primarily for use in industrial applications for quality control of particulate products. Such devices may have been evaluated for military/industrial uses to monitor for the presence of, and tentatively identify, airborne pathogens. This technology has been developed to the stage of commercial equipment with well-defined performance specifications. A major concern about the effectiveness of this technology is that the postal processing environment has a very high background level of particulates. The capability of a particle shape analyzer to effectively identify bacterial spores or other kinds of bioterrorism threats against this high background must still be proven. Based on the above, a high technical risk level is assigned to this technology. Operational Risk The use of particulate shape analyzers on processing and distribution center equipment such as the AFCS would not require retrofitting that might impact equipment. Operation of the particulate shape analyzers would require specialized user training and support, but this is not seen as a determining factor. Maintenance requirements are not known at this time. No environmental or regulatory issues have been identified, and workplace acceptance should not be an issue. Based on the above, a low to moderate operational risk level is assigned to this technology. Cost Risk Capital costs are estimated at $50,000 per unit. Assuming 2,000 units required at major processing and distribution centers, the total cost could be $100 million. Other operational and maintenance costs are not known. Cost risk is assessed to be low to moderate. Viability As was the case with the particle counter, the viability of the particulate shape analyzer hinges on its ability to identify bacterial spores or other kinds of bioterrorism threats (from a single contaminated letter) against a high background level of particulates such as is found in the postal processing and distribution center environment. Additional modifications may be required to improve this capability. Consequently, this technology appears to have Intermediate-Term viability subject to successful testing. As in the case of other triggering technologies, the particulate shape analyzer must be used in conjunction with a confirmation technology in order to provide effective detection of biohazards. 4.2.3.4 Laser Discriminator Description The laser discriminator is a device that counts and optically characterizes airborne particles. It measures the ratio of scattering to fluorescence of particles in an air stream continuously collected from a specific location. The resulting profile is then compared to established optical profiles for a match with other kinds of particles, including biohazardous agents. The resulting profile is then compared to established profiles for a match with other biohazardous agents. If a biohazardous particulate is introduced in the mail stream, a reading of the profile will be recognized as outside of a normal profile. Several variants of this device under pilot production are currently undergoing evaluation for possible military applications. This kind of device could be inserted into the mail-processing system at points where mechanical forces are likely to cause release of substantial amounts of spores from a piece of mail. Technical Risk Laser discriminator technology is a continuously emerging technology. Improvements in laser and optics technology could improve the device's performance significantly, but this may require some additional development before reaching a deployable device. The device is designed for military/industrial use to monitor for the presence of and tentatively identify airborne pathogens. It is a precision instrument that is likely to require periodic maintenance and calibration, although the exact frequency is not known. There are reports of degradation of performance over time due to deposits of particulate matter on the optics. A major concern about the effectiveness of this technology is that the postal processing environment has a very high background level of particulates. It remains to be seen whether a laser discriminator can effectively identify bacterial spores or other kinds of bioterrorism threats against this high background. It has been demonstrated to be effective in distinguishing bacterial spores from non-biological particles such as road dust. However, the technology has been assessed as having difficulty with the background. Based on the above, a high technical risk level is assigned to this technology. Operational Risk The relative instability of this technology suggests a high operational risk at this time since none of the operational risk criteria can be evaluated. Cost Risk Capital costs are estimated at $50,000 per unit. Assuming 2,000 units required at major processing and distribution centers, the total cost could be $100 million. Other operational and maintenance costs are not known. Lack of production units and a long operational history suggest a high cost risk for this technology. Viability High technical, operational, and cost risk suggests that this technology is not ready for near-term deployment. Additional development and testing is required to determine whether it has potential for Intermediate-Term viability. 4.2.3.5 Immunoassay Test Strip Description The immunoassay test strip is a small, self-contained, one-time-use test for the presence of a specific pathogenic agent. A sample (a single drop of a liquid solution or suspension) is introduced into a port, the test is allowed to develop, and the result is read visually or optically using an automated strip reader. The test strips have been used in environmental testing for the presence of pathogenic agents. They have been used in testing anthrax-contaminated areas following the discovery of contaminated mail. Immunoassay test strips were initially considered by the Postal Service as a possible confirmation test to follow a positive trigger with the air particle monitoring technology since they do not function unattended. They must be coupled with a liquid air concentrator. Technical Risk Immunoassay test strips are commercially available in variants from several vendors. Six to ten tests for different pathogenic organisms of terrorist concern are currently available from one vendor. The specificity of the tests is highly dependent on the antibodies selected, and the fact that some antibodies may not be species-specific. Any test strips selected would be evaluated against organisms present in the background. If additional assays are required, substantial lead-time may be required to produce antibodies and develop the tests. An alternative and somewhat less mature variant of this technology uses up converting phosphors in place of silver particles and can combine several tests into a single strip, each with a specific color readout. In addition, there are commercially available, disposable, integrated sample preparation and analysis cartridges that employ deoxyribonucleic acid (DNA) amplification and lateral flow assays to identify organisms. The device produces a test result within 15 minutes following application of a sample. However, there is concern that there may be an insufficient level of sensitivity for most applications. The specificity of the antibodies in the test is also an issue-not all tests that are nominally for a given organism are equally specific, and vendors must be compared carefully on this issue. The immunoassay test strips are not a certified technology and are specifically stated as not qualified for use in clinical testing. Hence this technology requires a more rigorous method of confirmation before action is taken. The extent of its use in various applications is unknown, but the devices are generally known as useful for environmental testing and have seen considerable use. Variants of this technology are under development and may be more viable. The combination of an air sampler, sample applicator, test strip, and readout device has been advertised as an integrated solution for testing for airborne particles of biohazardous agents. The effectiveness and reliability of this combination of devices is a concern. Based on the above, a high technical risk level is assigned to this technology. Operational Risk Used as a confirmation test for an air monitoring (triggering) system, immunoassay test strips can help establish the reliability of that system, as well as help determine the course of action following a trigger on the air-monitoring device. Implementation in a postal processing environment should be straightforward. The sampler and reader devices require a square foot or so of space and a low level of line power. There are no known environmental, regulatory, or occupational constraints on the use of these strips. Workplace acceptance should not be an issue. Based on the above, a low operational risk level is assigned to this technology. Cost Risk As expendables, the strips currently cost about $20 per test, a value that could be considerably lower in high volume. The strips are one-time-use, disposable items. Bench-top sampling and readout devices are each available in the range of several thousand dollars as a capital outlay. If the strips are used as confirmation tests in conjunction with an air particulate monitoring technology, and that technology is effective in alarming only when independent tests show that bacterial spores are present, then the usage rate will be relatively low. Based on the above, a low cost risk level is assigned to this technology. Viability Low operational and cost risks but a high technical risk suggest that this technology probably is not viable. Issues yet to be resolved are the adequacy of current sensitivity and specificity levels. Given the information available this technology is deemed to be Near-Term, but viability is questionable. 4.2.3.6 Polymerase Chain Reaction/Integrated Air Sampling/Sample Preparation Assay System Description PCR is a technology for detecting small quantities of DNA with a particular genetic sequence. Typically, tests are designed to be specific for a given species or strain of an organism. Tests for a pathogen usually focus on the genes responsible for its pathogenicity. If the target DNA sequence is present in any of the DNA in the sample, the reaction produces multiple copies of the target sequence. These multiple copies can then be detected directly or indirectly to give a positive test result. If no target sequence is present, no copies are made and a negative test result is obtained. PCR is broadly used in the biological sciences for organism identification. It has been used for clinical, forensic, and environmental testing for the presence of-and specific identification of-such things as pathogenic agents, human DNA, and interspecies relationships. In the context of Postal Service requirements, it is envisioned as a primary or confirmation test that would be used to monitor airborne particles released during automated mail processing and to detect biohazardous agents that may be present. It could be used for direct sampling and analysis of these particles, or as a follow-up to a positive trigger with the air monitoring technology. It could also be used as a confirmation test following a positive test with biological indicator strips. Technical Risk PCR is a mature technology that has a wide variety of experimental and commercial variants. Bench-top thermocyclers are available in some variety of designs, some of which employ an integrated microfluidic cartridge that automates the sample processing steps. Handheld thermocyclers are also becoming available. Variants also exist in which the PCR reaction is carried out at a constant temperature. Thermocycling instruments-some with optical readout and data management capabilities-are available from multiple vendors. Reagents for many tests are commercially available or can be made to order by specialty companies from specifications for previously developed tests. Development of new tests can be challenging, but adequate tests exist for most pathogenic agents of concern for bioterrorism. The specific technology under consideration is an integrated air sampling/sample preparation/PCR technology using disposable microfluidic cartridges. It is designed to automate the sample collection, preparation, analysis, and readout processes into a single seamless process. Two commercial variants of this system are available, but both are relatively new. PCR generally is an extremely sensitive assay method, and PCR testing routinely can detect as few as 50 copies (organisms) per sample within 15 to 30 minutes, and its theoretical detection limit is one copy of DNA per sample. Consequently, it is viewed widely as the "gold standard" of detection methods. Problems with this kind of assay may arise if certain contaminants are present that inhibit the DNA polymerase used in the reaction. Such contaminants are frequently found in environmental samples, but methods are being developed to filter and clean inhibitors to reduce risk. Based on the above, a low to moderate technical risk level is assigned to this technology. Operational Risk Operational impacts may vary depending on how PCR testing is used. When used as a confirmation test for an air-monitoring system, their use can help establish the reliability of that system, as well as help determine the course of action following a trigger on the air-monitoring (triggering) device. Following a determination of contamination, PCR tests may be used as part of the process of verifying successful decontamination (e.g., via surface sampling). Implementation in a postal processing environment should be straightforward. The sampler and thermocycler devices require several square feet of space and a low level of line power. The sampler device may have to be interfaced with air monitoring systems if used, or directly to mail-processing equipment. There are no known environmental, regulatory, or occupational constraints on the use of PCR. Workplace acceptance should not be an issue. Based on the above, a low operational risk level is assigned to this technology. Cost Risk The cost per assay-labor and materials-will run in the $10s to $100s range, depending on assay format, use of cartridges, and so forth; costs are expected to be lower in high volume. Research-grade bench-top thermocycling devices are in the range of $50,000-$100,000 in capital outlay; portable and handheld versions are less costly. To meet Postal Service testing requirements, approximately 2,000 thermocyclers would be required. For situations involving possible contamination at other facilities, samples could be transported to the nearest major processing and distribution center for analysis. If not used in association with triggering devices, each of the PCR instruments will need an integrated air-sampling device at a cost of about $3,000 each. The maturity of this technology results in the assignment of a low cost risk. Viability The technology is fairly well understood, and will be pilot tested in a mail-processing environment, where low levels of analyte, the possible presence of inhibitors and other interferents with the assay, and integration with the process are all factors that will be thoroughly evaluated. This technology is much more sensitive than the immunoassay test strips and is more flexible than the test strips (new assays can be added relatively easily) but more costly per test. Low operational and cost risks plus low to moderate technical risk suggests that this technology is deemed to have Near- to Intermediate-Term viability. 4.2.3.7 Mass Spectrometer/Air Particle Concentrator Description Mass spectrometry is an analytical method that identifies chemical species by their mass-to- charge ratio. Under some circumstances, it can be an accurate means of identifying specific bacteria. A mass spectrometer works by producing charged particles (ions) from the substances to be analyzed and then uses electric and magnetic fields to separate and quantify the ions by their mass-to-charge ratio. The instrument can interpret the masses and relative abundances of the ions generated from a complex (e.g., biological) sample to obtain information on the composition of the sample. Mass spectroscopy is a mature technology that has been used widely throughout the scientific community for decades as a means of identifying chemical unknowns and verifying proposed chemical composition and structure for new substances. It has been used widely by the military for chemical warfare agent detection in battlefield settings and by law enforcement in forensic applications such as detection of explosives residues. It could be deployed at the USPS as an integrated alternative to the combination of an air-monitoring technology and a confirmation-testing technology. Two unique solutions were presented to the Postal Service that attempts to automate the whole process and allow for continuous monitoring of the air. These systems use an air concentrator to collect a sample of the aerosolized particles and then present the sample for ionization and mass spectrometry. Technical Risk Research mass spectrometers are widely available commercially. The integrated air sampler-biological mass spectrometers being considered for Postal Service deployment are in pilot production and have limited availability. Mass spectrometers of various types are used in research environments for chemical identification. The technology has found limited but increasing use in microbiology for bacterial identification and cytology, largely due to new technologies for producing ions from high molecular weight solid materials. However, most biological applications of mass spectroscopy do not allow for real-time, continuous monitoring. These devices still require biochemists to perform manual sample preparation and analysis. Mass spectroscopy is a highly sensitive technique requiring very small amounts of analyte-for bacteria, hundreds of cells are sufficient for analysis. The promise of this technology rests on the observation that each species has its own set of chemical constituents ("biomarkers") that allows it to be distinguished from others. The relative proportion of these biomarkers can be viewed as a fingerprint for the organism. A limitation of this approach is that the relative proportion of these substances may vary depending on the conditions under which the bacteria are grown or to which they are subsequently exposed. Overall, it is a much bigger challenge to identify bacterial species from their mass spectra than to identify pure chemical substances by mass spectroscopy. It will require the development of an extensive reference library of mass spectra of both pathogenic and non-pathogenic bacteria, including those considered likely agents of bioterrorism (possibly under a variety of growing conditions. This is a potentially costly and data-intensive undertaking. Furthermore, it is a big leap to go from analyzing a homogeneous sample of bacterial cells of a single type, to the complex mixture of particles that one would encounter in a mail-processing environment. Based on the above, a moderate to high technical risk level is assigned to this technology. Operational Risk The operational considerations for implementing this technology in the Postal Service environment are nominal. The devices will require space and power but on a scale much smaller than the machines to which they will be interfaced/retrofitted. Operation, and to a greater extent maintenance, will require substantial training. Maintenance requirements are not known but may be significant. There are no known environmental, regulatory, or occupational constraints on the use of PCR. Workplace acceptance should not be an issue. Based on the above, a low to moderate operational risk level is assigned to this technology. Cost Risk The devices under consideration are expected to have initial capital costs of about $150,000 each for 1,128 units or $169.2 million. There will be nominal ongoing costs for consumables used during the operation of the device and for materials used for periodic maintenance. There will be potentially significant labor costs for maintaining the devices in working order. No other kinds of costs are expected to be significant. The current stage of development of the technology being considered by the Postal Service suggests assignment of a moderate cost risk. Viability The critical issues relative to this technology's viability in the postal environment are (1) whether it can function effectively given the high level of particulates expected to be present in processing and distribution centers and (2) its effectiveness in identifying specific pathogenic bioagents. The technology is in prototype/pilot stage and may be available in a timeframe acceptable to USPS, but if so, it will only be in limited quantities. In the near term, it may have to be supplemented with a combination of airborne particulate monitoring and confirmation testing. Additional testing of the technology is needed. Critical to the usefulness of the technology is that it be demonstrated to be able to positively identify and distinguish closely related bacterial species independently of their growth conditions and environmental history. In addition, it is critical that it be shown to work in a postal facility in the presence of the typical load of particulates found there. Given the above, this technology is deemed to have potential Intermediate-Term viability. 4.2.4 Intervention Intervention technologies under evaluation are those potentially applicable for the bulk sterilization (killing of all live organisms present) of mail prior to its entry into processing. These technologies primarily fall into two basic categories, irradiation and gaseous treatment. One additional physical method, ultra-high-pressure sterilization, was also evaluated. Irradiation technologies included for consideration are: electron beam (e-beam), X rays, gamma rays, ultraviolet light, and microwave. The first three of these technologies are evaluated together under "ionizing radiation" because of their similarity. Gaseous treatment technologies include chlorine dioxide, ethy