Appendix A USPS Environment, Facilities, and Mail Flow This appendix summarizes the some of the more salient and applicable characteristics of the USPS operations that must be considered when selecting appropriate counterterrorism initiatives. A.1 U.S. Postal Service Facilities and Customer Service Points of Contact The Postal Service is a vast enterprise with unmatched mail processing volumes and worldwide distribution of assets. The bulk of these assets are located domestically in and around postal facilities located throughout the United States. Of these assets, the most visible are those through which the public acquires products and services. Figure A?1 provides an overview of the most apparent Postal assets from the perspective of the Postal Service customer. Figure A-1. USPS Customer Service and Administrative Assets Not evident in Figure A-1 are the millions of bags, boxes, trays, hampers, rolling stock, and various over-the-road and aircraft containers that are in constant service throughout the postal operations. Types of Mail The Postal Service provides an array of services for a wide variety of mail items. Standard mail types are letters, flats, and parcels. These items may be introduced into the mail stream in many ways. Postal Service processes and procedures provide some degree of linking of some mail types to their point of origin and receiver. These include registered, express, certified, insured, postage due and COD mail, any item going through customs, and several other types. Of greater concern in the face of terrorist threats is the mail that is anonymously introduced into the mail stream. Anonymous mail may be collected from mailboxes and collection boxes, as well from thousands of drop points at customer sites, mail facilities, and other locations across the country. Mail Operations The USPS mail processing operation is a complex and diversified system, requiring the coordinated effort of mail processing plants and delivery units across the country. While much of this processing is labor intensive, with a large work force distributed across the country, much of the processing required to sort the mail for distribution has been automated by a series of high volume machines. Table A-1 provides a listing of some of the more commonly used equipment that processes the anonymous mail within USPS Processing and Distribution Centers (P&DCs). Table A-1. Mail Processing Equipment Equipment Estimated Quantity in Operation Dual Pass Rough Cull Systems "Barney" (DPRC) 280 Advanced Facer Canceller System (AFCS) 910 Multi-Line Optical Character Reader (MLOCR) 875 Letter Mail Labeling Machine (LMLM) 360 Mail Processor Bar Code Sorter (MPBCS) 800 Delivery Bar Code Sorter (DBCS) 4300 Carrier Sequence Bar Code Sorter (CSBCS)r 3730 Flat Sorting Machine (FSM) 470 Small Parcel and Bundle Sorter (SPBS) 350 Tray Management System (TMS) 30 Figure A-2 provides a logical view of the mail handling process showing collection, sorting, and distribution, as well as interaction between delivery units and processing plants and interaction between the processing plants. Figure A-3 provides a more concrete view of these processes, illustrating some of the equipment used to perform the processes. Figure A-2. Mail Flow Block Diagram Figure A-3. Mail Handling Overview Embedded within these operations are the Plant-to-Plant Interactions. Figure A-4 depicts these shipments. Figure A-4. Plant-to Plant Interaction This mail handling can be divided into three distinct operations, collection, sorting, and distribution, although the physical processes for collection and distribution within the delivery units are routinely preformed by the same work force and vehicles, often simultaneously in the performance of street operations. Appendix B Prevention B.1 Entry Point Control-Collection Box This appendix summarizes information that the USPS will need to have as part of its entry point control efforts to minimize the possibility that Postal Service employees will be exposed to biohazardous substances that have been introduced into Postal Service collection boxes. The Postal Service has about 350,000 collection boxes that are available to the public and that are used to introduce mail into the Postal Service mail flow. The Postal Service has limited means to protect the mail deposited in collection boxes that, generally, are not guarded and are not under surveillance. Multiple technologies could be used to enforce entry point control at the collection boxes. The Postal Service needs to minimize entry point vulnerabilities by developing technologies to monitor mail that enters the system through collection boxes. The technologies under consideration require that a mail containment technology be used inside each collection box. In addition to providing a single-use bag for containing the mail, and possible hazardous agents, this technology could provide the Postal Service with the capability to detect contaminants and to decontaminate the mail while it is isolated in a container. This proposed collection box with a containment feature has not been built or evaluated and is not available for near-term implementation. The Postal Service has issued a solicitation to invite submission of additional technologies for collection boxes. B.1.1 Containment Capable Collection Box Technical Description The Postal Service is interested in evaluated collection boxes that have been designed to contain mail in a separate box or containment bag while it is in the collection box and after it has been removed from the collection box. Suggested technologies from firms with knowledge of how the Postal Service uses collection boxes include the use of polyethylene bags inside each collection box and the use of coded information on the bags to trace mail back to its originating collection box. Mail dropped into the collection box slot would be contained/isolated in the bag. These bags would include barcodes that could be used to track mail in the bag to the collection box from which the bag was removed. The Postal Service has identified required functional capabilities that the containment collection boxes must provide. Containment capable collection boxes must be designed to include the following functionality: · Hold mail that is deposited in the collection box and isolate that mail from the box. This isolates both the mail and any hazardous materials that may be introduced into the box. · Isolates mail that has been removed from the box until it reaches a delivery unit or processing point. This protects the collector and protects against cross-contamination during transport. · Adaptable to collection mail at retail units (e.g., lobby drops). When the Postal Service has identified a technology that it plans to use, it will insure that the technology is adaptable for other uses. Possible additional functionality that may be used if practical includes: · Applying a unique code that can be used to track mail back to a collection box. This supports investigative efforts and should enhance deterrence. · Isolating mail while it is being tested to prevent cross-contamination in the delivery or processing unit. When these new collection boxes become available, the Postal Service expects to conduct extensive testing in multiple environments to ensure that the new box designs are compatible with Postal Service processes and with the climatic conditions to which the boxes are exposed. Availability/Development Status This technology requires that containment capable collection boxes be custom designed for the Postal Service. The Postal Service is aware that firms who are knowledgeable of Postal Service requirements are developing design concepts for containment collection boxes. The Postal Service plans to work with vendors in the development of acceptable designs. The lead-time for the design and development of candidate collection boxes is unknown. Therefore, availability of these boxes is unknown. Product/Procedure-Specific Information Since these containment capable collection boxes are not currently available, there is no reliable product specific information about them. During the design, the Postal Service will need to ensure that vendors address issues such as reliability, maintenance, production quality controls, durability in severe weather environments, resistance to unauthorized access, etc. Effectiveness Documentation of the effectiveness of the proposed technology is not available at this stage in development. Measuring the effectiveness for this type of prevention will be a multi-phase effort. The USPS will need to determine the effectiveness of the containment technology (including leakage when mail is deposited into the collection box, leakage in the collection box, and leakage when the carrier removes the mail from the collection box). Environmental Issues Not known. Would not be a significant factor since the materials and functionality will be similar to today's collection boxes. Costs The Postal Service has developed some initial projected costs for these redesigned collection boxes. Initial projected cost for acquisition of boxes is projected to be $352 million. This includes costs for modifications to lobby drop slots. The Postal Service will have to extend the cost to cover testing and installation as well as initial maintenance costs. The projected life cycle cost must include the cost of supplies, maintenance, storage, and distribution and is currently unknown. Operational Operational issues and costs will be design specific and are not currently available to the Postal Service. The Postal Service will work with vendors to ensure that potential operational issues are addressed early in the design process. The Postal Service plans to identify the impacts of operational issues such as: · Issues with installing and maintaining the boxes. · Operational procedures for handling the bags and the boxes, including space availability in vehicles for bags or tubs that must be kept intact during transportation. · Tracking collection bags and maintaining accountability. · Physical issues including footprint, noise, etc. when the boxes are installed in retail units. · Training requirements and training issues. Viability in the USPS Environment The Postal Service will establish criteria for ensuring that containment capable collection boxes are viable in all Postal Service environments. The Postal Service will also provide its requirements to vendors to ensure that the collection boxes satisfy Postal's primary objectives: · Protect Postal Service employees · Be compatible with the environments in which collection boxes are currently installed (indoor and outdoor, unprotected from the elements, no external power source, tamper resistant, etc.) The Postal Service will ensure that collection box designs must be compliant with Postal Service requirements to be considered viable candidates. B.1.2 Biohazard Detection Strips Technical Description Biological indicator strips technologies may be able to detect the presence of specific biohazards in mail received from collection boxes. The biological indicator strip provides unattended monitoring and instant readout and is a candidate for unattended monitoring in the collection box. The biological indicator strips are sensitive to pathogens and generally display a color reaction if the presence of specific pathogens is detected. They are not specific for pathogens, but give a positive result with some benign bacteria that have surface chemistry in common with pathogenic bacteria. Availability/Development Status The biological indicator strips are beginning to be commercially available. The availability of sufficient quantities of strips to implement this technology at all collection boxes could be a major issue. Product/Procedure-Specific Information Specific information on the biological indicator strips is contained in Appendix C. Effectiveness Detection strip technology was conceptualized with the food industry in mind. However, the Postal Service will require documentation of strip sensitivity in various environments and to specific pathogens. Sensitivity issues may require the Postal Service to develop the capacity to concentrate spores that could be in a collection bag or tub. The Postal Service will determine if equipment must be implemented to extract air from the collection bags or tubs and produce a spore rich medium (a candidate would be a commercially available air sampler). Biological indicator strips are susceptible to false positives because of a lack of specificity. False negatives are mainly a function of the sensitivity of the technology. The biological indicator strip can be used to determine the possible presence of biological hazards but would be used in conjunction with more reliable technologies for confirmation of the presence of a biohazard. Environmental Issues Environmental issues have not been documented for the use of detection strips. Disposal of used strips are issues that the Postal Service will address when it reviews this technology. Costs The biological indicator strips discussed in Appendix C cost about $1.00 per strip. The Postal Service will add overhead cost associated with using the strips when it establishes this technology as a viable candidate. Operational If documentation of the sensitivity and usefulness of these strips in a collection box environment is available, they will be prototyped in a working collection box to assess operational issue. Viability in the USPS Environment This technology will have to be tested further to evaluate its utility in collection boxes. B.1.3 Collection Box Decontamination System Technical Description Another option under consideration is to test a decontamination system located in collection boxes that consists of polyethylene bags in which the mail would be collected. After the mail is in the collection bags, the bags would be sealed and chlorine dioxide would be generated in the bag. This proprietary technology has not been tested or validated by the Postal Service. Chlorine dioxide exists as a gas at room temperature. An available technology for generating chlorine dioxide is from the reaction between sodium chlorite and hydrochloric acid. Additional information on chlorine dioxide is in Appendix E. As documented in Appendix E, chlorine dioxide is widely used as a bleaching agent, a disinfectant for liquids (water), a sterilant, and as a disinfectant for contaminated buildings. Availability/Development Status Cylinders of chlorine dioxide and also the products and processes required to make chlorine dioxide, are widely available. Chlorine dioxide is used for decontamination in a variety of environments. Appendix E includes documentation of these availability issues in Postal Service production environments. Appendix E does not address availability for collection box mail decontamination. As stated above, the polyethylene bag-based technology for using chlorine dioxide is a proprietary technology. Product/Procedure-Specific Information The product/procedure issues identified in Appendix E are relevant to the use of chlorine dioxide for collection box mail decontamination. The use of chlorine dioxide in collection bags significantly increases the risk that Postal Service employees could be exposed to the chlorine dioxide gas or to chlorine gas that is generated when chlorine dioxide breaks down. If the Postal Service determines that testing and analysis of this technology is appropriate, procedures for protecting employees will be addressed. Effectiveness The known effectiveness of chlorine dioxide is documented in Appendix E. The effectiveness of chlorine dioxide when used to decontaminate mail in a sealed bag is not known. The Postal Service will test the effectiveness of this technology once it is determined that this technology is appropriate in the collection box environment. Environmental Issues Appendix E documents that there are OSHA rules on maximum levels of worker exposure to chlorine dioxide gas and EPA rules on the release of chlorine dioxide gas into the environment. The Postal Service may determine that chlorine dioxide, in collection bags, is a viable technology. The Postal Service will then determine if generating the gas in a bag in the collection box is adequately safe or if the bags should be returned to a delivery or processing unit and the gas introduced into the bag in the delivery or processing unit. The Postal Service will work with vendors to determine procedures for venting gas from the collection bag. Procedures will also be developed for ensuring that mail from a decontaminated collection bag is free of chlorine dioxide gas before it is added to the mail stream for processing. Costs The costs to implement this collection bag technology are both direct and indirect. The direct cost covers the acquisition of bags, with decontaminant capability, $61 million annually. This does not include additional costs if the collection boxes must be codified or replaced to support this technology. Other direct costs items include (1) costs to develop and implement procedures to vent gas from bags; (2) costs to implement environmental monitoring capabilities; (3) costs to process decontaminated mail to eliminate chlorine dioxide residue, and (4) costs to dispose of bags, and possibly captured gas if there are EPA restrictions. Indirect costs include (1) impacts on mail processing volume; (2) increased labor costs; (3) possible liability costs; (4) on-going testing and certification costs; (5) cleanup including schedule and unscheduled costs, and (6) possible costs due to public awareness issues tied to the use of potentially lethal gas in a Postal Facility or in a collection box. Operational The Postal Service's evaluation of this technology will include analysis of operational considerations and constraints imposed by the use of chlorine dioxide in collection boxes or possibly in mail-processing plants. The risk of employee exposure will impose requirements that mail from decontaminated collection bags be processed in an environment that protects the employees from possibly exposure to chlorine dioxide. The Postal Service will evaluate and respond to operational issues including the following: · Chlorine dioxide leaves a residue that is potentially harmful to employees. In areas where decontaminated mail is processed, the Postal System will develop procedures to monitor and eliminate residue. This effort will become a necessary, an integral part, of site operations. · An incident in which the chlorine dioxide gas escapes into the general work areas could result in the closing of the site until the gas has been dissipated and the residue eliminated. · The Postal Service will develop hazardous material training requirements for employees so that the employees and the customers are protected from potential exposure to the chlorine dioxide gas. · Maintenance operations will be modified to include special procedure for areas in which decontaminated mail is processed. · The Postal Service will evaluate the operational reliability of the technology to generate, and dissipate, the gas in the collection bags. · The chlorine dioxide decontaminates the surface of the mailpieces. The Postal Service will need to investigate further risk of contamination from leakage during mail processing operations. Viability in the USPS Environment The viability of the chlorine dioxide treatment of collection bags is questionable until the Postal Service is able to test the collection bag with the integrated chlorine dioxide capability. If the Postal Service decides to proceed with testing, it will evaluate the efficacy of using the decontamination capability provided with the collection bags by testing multiple variations of content, amount, climatic conditions, etc. This testing will be completed early in the evaluation phase for this technology. This testing will determine if the decontamination process is effective in an operational environment. The Postal Service will have to determine if the impacts of facility changes required to use chlorine dioxide/ collection bag technology outweigh the benefits derived from using this technology. The overall viability of this technology is critically dependent on the results of Postal Service testing. B.2 Entry Point Control-Retail Security Initiative This section summarizes information that the USPS will need to have as part of its entry point control efforts to minimize the possibility that Postal Service employees and customers will be exposed to biohazardous substances introduced through retail units. The Postal Service currently has video systems in retail postal units that could be used as part of the Retail Security Initiative to enhance the security of the mail-processing environment. The Retail Security Initiative will record retail transactions so that items purchased during these transactions can be correlated with items in the mail stream, if that correlation is required as part of a biohazard or other security investigation. The correlation of retail items with retail purchases and the recording of retail transactions provides the Postal Service with tools to trace retail customers who could have introduced biohazardous materials into the mail system. Having this capability will substantially reduce the level of anonymity that currently exists when customer bring mail to Postal Service retail units. A significant issue that must be resolved as part of implementing the Retail Security Initiative is the development of a technology for encoding retail products so that the Postal Service can maintain records of when and where Postal Service retail items are sold. The Postal Service has developed an approach for encoding some classes of mail using modifications to the existing POS ONE application. This approach is can provide both schedule and financial benefits to the Postal System since it is built on existing technology. This Postal System strategy is currently the most feasible candidate for implementing a retail security initiative. B.2.1 Positive Product Tracking System Technical Description The Postal Service proposes to develop a positive product tracking capability for retail security. The capability will be built by leveraging existing capabilities of the POS ONE system. POS ONE components will be modified or replaced as required to implement new functionality. The Postal Service will also integrate with the Robbery Burglary Retail (RBR) and Criminal Investigation Systems (CIS). Development of this positive product tracking capability will result in integrated video and retail systems that will record, store, and transmit information that can be used to correlate retail transaction information with video information. Existing capabilities are currently used to provide a video record of a retail unit's sales activities. Existing systems use both custom components and commercially available components. The positive product tracking capability will record retail activity within a retail unit. It will simultaneously encode mail with a unique identifier and record unique information along with the video. This provides the capability to match a product sale with an image of a customer. The recorded information can be stored locally or remotely and can be transmitted to other Postal Service sites. The specific information that will be encoded for each retail item has not been determined. That encoded information will be recorded and stored as part of the Retail Security Initiative. For example, if the retail unit sells 100 stamps and 250 stamped envelopes, unique identifiers will be associated with those stamps and envelopes and also correlated with the video. The Postal Service will develop additional documentation of how current technologies will be modified and developed for both near-term and mid-term capabilities. Availability/Development Status The POS ONE systems and the video units are already operational in Postal Service retail units. The Postal Service has developed a strategy and schedule for developing and installing the positive product tracking capability. The Postal Service proposes that this capability will be phased in over a 2-year period. The Postal Service will need to determine the modifications that will need to be made to the POS ONE printers (PVI or IBIP systems) or if those systems will need to be replaced. The Postal Service will also work with vendors to determine estimated costs and time constraints for acquiring systems that can provide the following capabilities: · Encode unique identification data on retail merchandise. · Read encoded data during a retail transaction. · Record encoded data with adequate information to correlate a retail transaction with a video image. Product/Procedure-Specific Information Video recording systems are currently installed in some Postal Service retail stores to capture and store customer images. The POS ONE system is also currently in use. The only issue relevant to these products and procedures are the impact of expanding the amount of information being recorded and stored and adding a new data source to the recorded video images. The Postal Service will not identify near-term and long-term maintenance issues (USPS, vendor, third-party) until the equipment and network configurations required for the positive product tracking capability have been determined. As part of its evaluation efforts, the Postal Service will address privacy and public relations factors that will develop when customers become aware of the expanded capabilities of the positive product tracking capability system. The Postal Service will use established models to evaluate the impacts from long-term storage of the collected video/retail data. The retention of video images will have to be addressed for total costs, long-term costs, facility impacts, and privacy issues. Effectiveness The POS ONE and video systems are currently in use and have provided uneventful operations. The implementation of the positive product tracking capability may stress some components of the existing systems and could require new and modified components. The effectiveness of the modifications, and the impact of the modifications on existing capabilities will be determined prior to full system development. Additionally, prior to system development the Postal Service will address the following issues. · Communications capacity requirements · Long-term storage requirements · Production impacts of uniquely encoding retail merchandise Environmental Issues There are no known environmental issues. Postal Service employees and customers will have no direct interfaces with the positive product tracking capability other than those that already exist as part of POS ONE. Costs The Postal Service has developed initial projected costs of about $250 million to acquire equipment for 15,000 retail units. The Postal Service has documented projected development cost for three sequential time-periods. Short Term - $13 million Mid-Term - $33.5 million Long Term - Over $70 million The Postal Service will also evaluate life-cycle costs as part of the development effort. The components covered under the proposed $250 million will be identified so that actual costs can be accurately projected. For example, there may be additional initial and life cycle costs that must be addressed in addition to the cost for video expansion (new printing systems may be required). Some system related activities/items that may result in additional costs include: · Costs to provide adequate storage for collected retail unit data (video images, retail information, etc.). · Costs to support additional communication capabilities and capacities. Public awareness of this proposed technology could prove to be a significant negative factor. The Postal Service will have to acknowledge that Retail Security technologies are implemented in public areas of retail units and that images are being associated with transactions and are being retained. This could have a negative impact on the perceived role of the USPS. Operational The implementation of the positive product tracking capability will significantly impact storage requirements/technology. Expected costs to develop an operational system include both capital and maintenance costs if the printers have to be replaced. Replacement equipment will also impact current maintenance procedures. There could be facility communications capacity issues that impact operational capabilities. The Postal Service will evaluate operational issues as part of the system design effort. Postal Service operations training requirements will be dependent on the technology chosen for encoded retail merchandise. The encoding technology will drive the selection of equipment required to read the encoded information. The selection of equipment will drive the required training. The selection of equipment will also impact maintenance procedures and maintenance requirements. As part of its design effort, the Postal Service will evaluate the impact of modification and upgrades on POS ONE reliability and will provide a design that maintains or improves existing performance metrics. Viability in the USPS Environment The viability of the proposed positive product tracking capability will be determined by the hardware, software, and technical architecture design. The impact of the positive product tracking design on POS ONE viability will also be evaluated. The Postal Service plans to leverage the POS ONE technology to satisfy its Retail Security Initiative requirements. Primary technology unknowns that could affect the viability of the positive product tracking capability are storage capacity, network capacity, and the equipment required to encode data on retail merchandise. The Postal Service has developed a preliminary schedule for implementing the positive product tracking capability. The schedule provides an ambitious effort that will provide the Postal Service with prevention capabilities with minimal impacts on existing systems. Developing detail designs, and the efficacy of those designs, are critical to determining if the Postal Service schedule can be achieved or how it must be modified. The Postal Service can best achieve its projected development schedule by initiating an immediate evaluation of existing and planned systems. B.2.2 Security Process for Commercial Mailers Description The potential for receiving mail that has been contaminated with a biohazardous substance will be reduced when mail has been prepared for submission to the Postal Service in environments that are protected by standard security procedures. The Postal Service receives large quantities of mail from commercial mailers. The Postal Service proposes to enhance entry point control security by establishing cooperative security efforts between the USPS and its commercial mailers. An objective of these cooperative efforts is to minimize the potential for receiving hazardous mail from commercial mailers by having the mailers commit to meeting minimum security standards developed by the USPS and mailer representatives. After the USPS has verified that a larger mailer has met these security standards, the USPS will assume that all mail received from that commercial mailer was "safe" when it arrived at a Postal Service facility. Mail received from a commercial mailer who has complied with security standards will not be scheduled to receive any special handling for the detection and neutralization of biohazardous contaminants. Mail received from commercial mailers that have not complied with security standards will be treated the same as anonymous mail. Anonymous mail will be considered "safe" after it has been processed through USPS detection, neutralization, or other procedures. The effort to develop, implement, and monitor security standards will not be time limited. The USPS will maintain resources that will be available to develop and monitor the use of security standards for larger mailers. After security standards have been developed, the Postal Service will work with commercial mailers to evaluate if they have complied with security standards established by the Postal Service working with mailer representatives. The Postal Service will continue to monitor the commercial mailers to ensure that compliance with security standards is maintained. This prevention effort is procedural and is not a named technology. The Postal Service will develop Security Standards in coordination with representatives from commercial mailers. Technical Description This Postal Service initiative will provide an operational/business environment in which larger mailers will implement security practices at their sites to protect mail before it is delivered to the Postal Service. This initiative will be used to accomplish the following activities: · Establish organization to develop, implement, and monitor security efforts by larger mailers. · Meet with commercial mailer representatives to develop security standards for mailer facilities. · Document how commercial mailers can satisfy security standards. · Establish criteria for evaluating commercial mailer compliance. · Develop schedules for initiating commercial mailer compliance activities. · Work with field representatives to develop procedures for receiving and segregating "safe" mail from commercial mailers. · Establish evaluation and compliance criteria for monitoring the status of commercial mailers security standards implementations. · Develop incentive options for achieving wide-spread compliance by commerical mailers. As a result of developing and implementing this initiative with commercial mailers, the Postal Service expects to reduce that volume of mail that must be evaluated using detection technologies before it can be introduced into the mail processing system. This initiative will be successful if the Postal Service can involve commercial mailers so that they are willing to comply with Postal Service security standards and the Postal Service develops the mean to monitor commercial mailer compliance activities. Availability/Development Status The requirements for establishing this threat prevention initiative are not currently available and the security standards the Postal Service will supply to commercial mailers have not been developed. Postal Service commercial mailer security standards will be developed as part this threat prevention initiative. Postal Inspection Service representatives will work with representatives from commercial mailers to develop security standards that will provide a level of security that meets Postal Service requirements. The Postal Service will develop in-plant procedures for segregating "safe" mail (from commercial mailers who are compliant with security standards) from mail that is not rated as "safe." Mail processing flows will be developed to reflect this segregation of the mail. In-plant equipment configurations will also reflect this segregation of the mail since filtering and sanitization technologies will not be required for mail received from compliant commercial mailers. The Postal Service will also develop long-term plans to provide on-going support and over-sight for commercial mailers. This will require increased staffing and long-term planning for the allocation of resources over widely dispersed areas. The time required to develop and implement security standards for commercial mailers has not been determined. Security standards must be developed with representatives from the commercial mailers. Some larger mailers may need security standards that are mailer-unique. Resource requirements and schedules for security standard development are unknowns that must be determined. Product/Procedure-Specific Information The development and use of security standards for external organizations is not a new concept. It has been used for classified efforts for decades. Additionally, the concept of having one company monitor another company's facility operations is widely accepted since many manufacturing companies mandate facility requirements (e.g., cleanliness standards for the production of scientific instruments, etc) for their suppliers. An obstacle the Postal Service must overcome is that in most instances the organization that is acquiring products or services, the customer, identifies the requirements it will impose on its vendors and the vendors comply to get the business. The Postal Service faces a more challenging environment since it is the vendor and wants its customers to meet certain standards. The Postal Services will have to determine what leverage is appropriate to ensure that its customers, commercial mailers, will comply with Postal security standards. The Postal Service must develop in-plant procedures to automatically route mail from compliant mailers. The in-plant procedures could initially include the use of equipment that has not been modified to provide prevention, containment, and neutralization capabilities. The Postal Service will develop the following processing requirements: · Accept and segregate mail from compliant mailers (mail is classified as "safe mail"). · All "safe" mail containers received from commercial mailers will be identified and documented so that the Postal Service can track if contaminated mail is received from a "safe" mail source. · Introduce "safe mail" into the processing flow on equipment that is segregated from contact with mail that is either anonymous or from non-compliant mailers (affects load-balancing at the plants) includes containers. · Process mail in segregated mail streams. · Establish procedures for integration of mail streams after "unsafe" mail has been either cleared or neutralized. Long-term maintenance issues are administrative, personnel resources, and the capacity to process segregated mail streams. The Postal Service will need to provide personnel resources to monitor existing mailers and to assist new customers in becoming compliant with security standards. The Postal Service needs to establish and maintain administrative procedures to document the processing of "safe" mail in Postal Service facilities. The concept of establishing controls for external company facilities is not new. It has been used extensive by government agencies and commercial organizations. However, the concept has not been applied to the Postal Service or to mail processing operations. The Postal Service will address staffing, processing, and resource issues as part of the initiative development effort. The Postal Service is identifying and resolving long-term issues as part of its development efforts. Long-term issues that will be resolved by the Postal Service include: · Providing on-going support to commercial mailers. · Providing support to mailers to help them implement security standards that are compliant with Postal Service requirements. · Maintenance of sufficient staff to monitor compliance. · Maintenance of in-plant capabilities for processing "safe" mail in a segregated mail stream. · Maintaining levels of service to larger mailers who are compliant with Postal Service security standards. Effectiveness A primary issue that the Postal Service will address before initiating this effort with commercial mailers is evaluating the impact of this effort on mail processing operations at affected Postal Service sites. The segregation of "safe mail" could require that processing plans be changed since some equipment will not be available to process mail that was not classified as "safe." The Postal Service will monitor the impact of segregating "safe" mail on the overall operations at each plant. Environmental Issues There are no direct environmental impacts created under this threat prevention initiative. Processing of "safe" mail will be the equivalent of the procedures in general use throughout the Postal Service. The procedures used to process "anonymous" mail are new. These procedures will have no direct environmental impact. There will be indirect impacts based on the technologies selected to detect and neutralize contaminated mail. Costs The initial costs for the development and implementation of security standards for commercial mailers is not known. The life cycle costs will be dependent on the number of commercial mailers who agree to participate in this initiative. There could be additional costs if the Postal Service determines that it must provide commercial mailers with financial or performance incentives to encourage participation in this initiative. Initial projections indicate that the Postal Service will need to increase the security resources available to its field divisions. These staff resources will be used to maintain a program of monitoring and re-evaluating the security compliance efforts of participating commercial mailers. The Postal Service estimates that security support for the field could be achieved with the addition of 90 new postal inspectors who will be added to the security teams in Postal Service field divisions. Operational The operational costs associated with this prevention initiative are mainly the personnel costs required to monitor larger mailer compliance with the Postal Service security standards. There could be operational cost impacts in the plants that are triggered by the requirement to maintain segregated mail flows for "safe" mail and anonymous mail that has not been cleared or sanitized. There will be training requirements for the staff who monitor commercial mailer compliance. There could also be additional training required to maintained segregated mail flows within the plants. Viability in the USPS Environment This prevention initiative is a viable alternative that can be implemented with minimal cost to the Postal Service. It can be implemented in the near-term since the development efforts (developing compliance criteria) can be done internally and does not require that new contract be competed for prospective vendors. When implemented this initiative will significantly reduce the volume of mail that must be processed by detection and neutralization technologies. The Postal Service will pursue very near-term evaluation of the requirements for this initiative and of the impacts on the Postal Service and its customers. The Postal Service can quickly initiate efforts to develop security standards and to recruit potential candidates from its commercial mailer customers. B.2.3 Acceptance Procedures/Technology The function of a Postal Service facility is to receive mail from external locations and to send mail to external locations. This is accomplished by the continual arrival and departure of Postal Service and third party vehicles. This continual traffic exposes the Postal Service to the possibility that third parties could use vehicle traffic to attack Postal Service facilities and the employees at those facilities. The Postal Service will develop regulations and procedures to increase the level of security at access points and thus minimize the level of risk from vehicles and individuals using those access points. The Postal Service will use procedures and technologies to control access to Postal Service facilities. Technical Description The Postal Service will enhance security at its 400 P&DC, P&DF, AMC, and BMC facilities. A security initiative will be developed and implemented to establish upgraded controls on all individuals and vehicles that use truck entrances to access or leave these Postal Service facilities. This enhanced security will include new and expanded electronic systems and extensive staffing upgrades at all affected entrances. This security initiative will require significant investments in electronic and mechanical systems at affected entrances. · The Postal Service will install access control devices at entrances to physically block traffic movement through those entrances. · The Postal Service will install cameras and video monitors at entrances to monitor and record vehicles and individuals who pass though a controlled entrance. · The Postal Service will install badge and card readers at entrances. These readers will control access to individuals who have been pre-authorized and have been issued badges or encoded cards. · The Postal Service will provide intercom and/or video communications between controlled entrances and security staff. · The Postal Service will install enhanced lighting to assist security staff in monitoring entrance traffic. The security initiative also requires increased levels of staffing and training operations to ensure security personnel are available to staff entrances and that staff are cognizant of security requirements and how security devices operate. The expanded equipment that is installed at controlled entrances will impose an additional maintenance burden on facility staff. The security initiative will respond to the increased maintenance requirements by providing increased staffing and increased training for maintenance staff resources. The Postal Service has access to Government and commercial organizations that routinely provide extensive security support at entrances to their facilities. The Postal Service will develop its security initiative by leveraging the experience and knowledge these organizations will share with the Postal Service. This enhanced security initiative is critical to providing a layer of prevention against potential terrorist attacks. The Postal Service is vulnerable to the introduction of bioterror components via the entry of unauthorized or unknown individuals or vehicle traffic to Postal Service facilities. This security initiative will significantly reduce the vulnerability level at postal facilities. Availability/Development Status The Postal Service is proposing to implement its security initiative using commercially available equipment and technologies. The Postal Service expects to benefit by using production ready technologies, minimizing test and evaluation requirements. The significant number of facilities that the Postal Service plans to upgrade could impact the availability of some equipment. As part of its security initiative the Postal Service will evaluate lead-time requirements for security components. It will have the flexibility of configuring its security systems to accommodate possible acquisition impediments. Product/Procedure-Specific Information The products that will be used to implement the Postal Service's security initiative will be determined as part of the initiative development effort. Product and procedure specific information will be developed as the security component are identified and included in security architecture that will be developed for each facility. The Postal Service will use security components that are currently in use and proven. This approach will provide the Postal Service with up-front knowledge of performance and maintenance issues that will be critical to 24/7 security coverage at postal facilities. Effectiveness As stated above, the Postal Service intends to leverage the experience and knowledge of other Government and commercial organizations when developing its security initiative. The Postal Service expects to have performance metrics available before it commits to any production level technology. These performance metrics will enable the Postal Service to maximize the effectiveness of its security configurations at each facility. The Postal Service plans to use security components that have been implemented at by other organization and have a documented level of operational success. Environmental Issues Security components generally have minimal impacts on the environments in which they are installed. The Postal Service will use security components that are compatible with the environmental parameters of the facilities in which they will be installed. The Postal Service will address issues that are unique to each facility. Extensive placement of high-intensity lights could be incompatible with a nearby residential community. Some electronic equipment could affect nearby homes or business. These issues will be identified and resolved for each facility. Costs The Postal Service has developed initial cost estimates to implement its security initiative. The Postal Service estimates that the cost to upgrade existing systems, install new systems, and provide maintenance support for these new and upgraded systems at the identified facilities will be $64 million. The Postal Service estimates that the yearly cost to fully staff the controlled entrances at the identified facilities is $70 million. The cost for the installation and maintenance of the Postal Service's comprehensive security initiative is $134 million. Operational Operational issues identified as part of the security initiatives will, generally, be facility and/or security system unique. Facility configurations impact security operations. Equipment capabilities and configurations impact security operations. Operations requirements and issues will be developed as integral parts of the security initiative. Viability in the USPS Environment The Postal Service has not documented any facility or site conditions that will preclude the implementation of required security capabilities at the 400 identified sites. Sites unique conditions may be identified that require equipment or procedural modifications at a facility. These will be fully documented during the development of the security initiative. Appendix C Protection and Health Risk Reduction This appendix summarizes the evaluation of technologies for the protection of employees and customers by the reduction of human health risk. The primary initial focus of human health risk reduction is in the mail processing facilities. It is here where the processing of mail containing biohazardous materials will likely release airborne contaminants such as anthrax spores, resulting in an immediate risk to postal employees. The strategy of Health Risk Reduction addresses the potential for this immediate risk by evaluating technologies to protect human health in the following three areas: · To prevent the release of biohazardous airborne materials such as anthrax spores from mail processing machines. The technology being evaluated in this area is the installation of custom-designed permanent vacuum filtration systems on each type of mail-processing equipment. · To capture or kill infectious bioagents that may enter the heating, ventilating and air-conditioning (HVAC) system of a postal facility. Technologies being evaluated in this area include installation of high efficiency filtration, as well as the use of higher technology methods such as ultraviolet light, ultrasonics, or biological agents. · To prevent routine cleaning procedures from dispersing respirable bioagents in airborne form. The technology being evaluated in this area is to replace blowing and dry sweeping methods with vacuum cleaners equipped with high efficiency particulate air (HEPA) filters for the routine cleaning of facilities and equipment. C.1. Permanent Vacuum Filtration Systems on Processing Equipment Technical Description The potential risk to USPS employees of exposure to airborne hazards released by mail processing equipment will be reduced by the addition of an air-cleaning system, to existing letter mail processing equipment. This system, which will be custom designed for each type of equipment, will automatically and continuously vacuum letter mail processing equipment ensuring that minimal dust escapes from the equipment. The air from inside of these machines will be filtered using HEPA filters before it is discharged back into the mail processing environment. The continuous flow of air into the equipment and the discharge of air through the HEPA filters will reduce the release of airborne hazards from processing equipment into the facility by several orders of magnitude. Availability/Development Status This technology requires the custom design and fitting of ventilation/filtration equipment onto existing machines and the uniform system wide deployment in a narrow time frame. Experience with and intricate knowledge of mail processing equipment, and the acquisition of expert knowledge of air movement, filtration, and behavior of biohazards will enable the USPS to apply this technology. Prototype systems are being put in place for evaluation. A schedule for the field testing of prototypes and nationwide deployment of technology is shown in Table C-1. As seen in this table, a prototype air-cleaning system for the Delivery Bar Code Sorter (DBCS) was installed in January in the Dulles VA P&DC for field evaluation. A prototype air-cleaning system for the Advanced Facer Canceler System (AFCS) will be installed in mid March in the Dulles VA P&DC for field evaluation. Table C-1. Air-Cleaning System Field Testing and Deployment Schedule Equipment Field Test Deploy AFSM 100 Mar-02 FY 03-04 DBCS Jan-02 FY 03-04 AFCS Mar-02 FY 03-04 DPRC Mar-02 FY 03-04 Loose Mail System (010) May-02 FY 03-04 Product/Procedure-Specific Information The basic use of a permanently installed continuously operating vacuum system on mail processing equipment is not a new idea for the USPS. Previous USPS research efforts were aimed solely at the collection of nuisance dust to improve maintenance on our machines. The technology proposed here is a combination of this previous research and response to the finding of biohazards in the mail stream. The HEPA filtering technology proposed here, as the final filtering stage to remove the smaller particles that constitute airborne biohazards is the same as that used to protect human health in facilities that handle highly infectious organisms, including anthrax. Machines with a relatively closed mail pathway are seen as better candidates for the initial prototyping of vacuum systems than more open machines. These machines are also more unitized and standard, such as the AFCS, Automated Flats Sorting Machine (AFSM 100), and the DBCS, which facilitates widespread deployment of a uniform modification. In addition, acquisition is in progress to design and fabricate modifications to the conveyor systems that transport collection mail from the entry point to the initial processing systems. These conveyor systems are not enclosed and vary in architecture according to plant size and floor layout. The absence of existing hoods and shrouds over these systems will require mechanical designs and changes to enclose these systems so that particulates and contaminants released from these systems can be extracted, entrained on filters and removed from the environment. Effectiveness USPS has developed strategies to take permanent vacuum systems beyond previous efforts aimed at nuisance dusts. The new proposals have vacuum intake at many more points than previously considered. The discharge of the vacuum system is now far more effectively filtered. Systems in prototyping utilize multi stage vacuum filtration, to initially filter out the larger particles to prevent their plugging of the finer filters. The final filtration stage is a HEPA rated filter. HEPA filtration is 99.97 percent efficient at 0.3 micron particle size. Biohazardous particles typically fall into the range of 1 to 10 microns. Thus this HEPA filtration stage will significantly reduce the amount of particles that exhaust from the vacuum system, and into the ambient air of postal facilities. HEPA filtering technology is the state-of-the-art technology for removal of particulate biohazards and other particles in the micron size range. It is used in countless facilities around the world for bio-safety facilities, electronic clean room assembly, isolation wards, surgical theaters, bioengineering, pharmaceutical processing, and any application where maximum state-of-the-art reduction or removal of sub micron particulate material is required. The primary advantage of the proposed system is that airborne particles that may be released from mail upon entering the machines will be captured at a high efficiency by the filtration vacuum system. This will reduce operator exposure to airborne particles. Removal of particles from the machine prevents them from contaminating the ambient air, the equipment, and other mailpieces. A second exposure is also substantially reduced with the permanent vacuum system. This exposure may occur when maintenance personnel routinely clean the accumulated dust and debris in the machine on a daily basis. The former process of blowing out the dust with compressed air has been banned since October 2001. That process allowed the dust to become airborne. The current process is to hand vacuum the internal workings of the machines. A permanent vacuum system, installed as part of the machine, reduces or eliminates the need for that task, and the associated exposure of maintenance personnel. A limitation of the vacuum filtration system is that it has no effect on any particles that remain inside the letter envelope. In addition, while 99.97 percent of the particles released from a mailpiece will likely be captured, some small percentage (0.03%) of particles could theoretically pass through the filter and be released into the facility. While this does not afford absolute protection, it reduces human exposure, cross contamination, and facility contamination by several orders of magnitude, accomplishing a significant reduction in human health risk. Performance data on the specific custom systems installed on mail-processing machines could be generated by introducing spores from harmless anthrax surrogates into the system and monitoring the egress of live spores from the system. Another performance issue will be the potential for plugging of the HEPA filter by the large amount of paper dust generated in the mail-processing system. A multi-stage filtration system is used to protect the HEPA filters from this possibility. It will be important to evaluate the effectiveness of the multi-stage filters in the prototypes deployed. Environmental Issues Since the purpose of this technology is to provide a cleaner working environment and to reduce human health risk by removing airborne contaminants from the facility, it is an environmentally friendly insertion. Reducing the concentration of airborne contaminants will likely improve the assessed impact of the facility on the surrounding environment. The disposal of filters from the technology must be accomplished in a way that prevents the release into the environment of virulent organisms potentially trapped on the filters. Identification of filters as biohazardous could be accomplished by the use of detection technology to detect the presence of hazardous organisms in the machines. Filters that were present during such a detection will be treated in a non-routine way to assure the containment and destruction of any trapped infectious organism. The USPS is working with National Institute of Occupational Safety and Health, NIOSH, to establish requirements and to evaluate prototype systems. Costs Unit Cost: The estimated unit cost of the custom retrofitting of machines presently in use is approximately $50,000 per machine for DBCS, and AFCS; $200,000 for loose mail systems or 010 operations; and $85,000 for AFSM 100 machines. In addition, logistical and contingency costs per machine are estimated at $15,000 for AFSM 100, DBCS, and AFCS machines, and $20,000 for loose mail systems machines. Table C-2 summarizes the total costs of applying this technology throughout the Postal System. Table C-2. Total Costs to Apply Technology Throughout Postal System Equipment Quantity Cost each (000) Logistics/Contingency(000) Sum (000) AFSM 100 560 $85 $15 $56,000 DBCS 5200 $50 $15 $338,000 AFCS 1100 $50 $15 $71,500 Loose Mail/010 292 $200 $20 $58,400 CSBCS 3732 $20 $74,600 Total Cost: $598,500 Prototype Development is estimated at $280,000 for AFCS, $250,000 for DBCS, and $500,000 to $750,000 for the Loose Mail Systems. Initial deployment of the filtration vacuum systems will be to equip all of the 1100 AFCS machines, 560 AFCS100 machines and approximately 1800 of the outgoing DBCS machines for a total equipment cost of $211 million. The DBCS machines sending mail out to other facilities will be chosen for this initial deployment. Additionally the installation of shrouding and filtration in 292 facilities will require an estimated initial outlay of about $60 million. The total initial cost estimated for deployment of retrofitted vacuum filtration systems is thus $271 million. This does not include logistical and contingency costs. This initial deployment leaves 3400 DBCS machines to be retrofitted in the future at an estimated equipment cost of $170 million. Operational Operational demands of this system are increased energy consumption, decreased machine accessibility, increased heat load on HVAC equipment, costs of servicing the vacuum equipment, and loss of floor space. Design efforts will aim to mitigate each of these impacts. Maintenance of these systems will involve the changing out of filters at appropriate intervals to assure that plugged filters will not compromise the airflow. This can be done during normal down time of the machines and would not have a significant operational impact. Filters that were present during detection of a hazardous organism will be treated in a non-routine way to assure the containment and destruction of any trapped infectious organism. Viability in the USPS Environment Initially, the DBCS, AFCS, and AFSM 100 will be retrofitted with the prototype filtration vacuum systems. It is expected that the lessons learned during the prototyping of these systems will allow an efficient adaptation to other letter mail-processing systems, such as MultiLine Optical Character Readers, Mail Processing BarCode Sorter and Carrier Sequence BarCode Sorter, should those prove to be appropriate for retrofit. C.2 Filtration Systems in HVAC Technical Description The possibility exists that airborne anthrax spores can be trapped and possibly killed in the HVAC systems in postal buildings. Ordinary HVAC systems contain air filtration systems to prevent heating and cooling coils from becoming clogged with airborne dust and dirt. Anthrax spores are small enough to pass through most filters used in ordinary systems. It may be possible to upgrade the efficiency of filter media to capture anthrax. Another possibility is the use of high-tech methods such as ultraviolet light, ultrasonics, or biological agents to kill anthrax spores traveling through the ducts. Availability/Development Status The Postal Service is conducting a feasibility study to investigate improved filtration and high tech methods. This investigation will include: · Evaluating five "typical" facilities of various sizes. · Funding for consultation with other government agencies. · Evaluation of filtering and decontamination devices. Product/Procedure-Specific Information Technology areas under investigation are: · Enhanced filtration · Ultraviolet light · Ultrasound · Antimicrobial agents Effectiveness A study is under way to evaluate the potential effectiveness of the potential modifications in the HVAC in the postal environment. Some of the anticipated advantages of improved filtration are: · May provide a positive method of capturing anthrax spores that enter the HVAC system. · Much of the infrastructure (i.e. ducts and fans) is in place. Some of the anticipated advantages of the higher tech methods are: · Possible lower cost than improved filtration. · May be used in some combination with filtration to kill anthrax spores. Some of the anticipated technical issues are: · These methods have not been successfully demonstrated on the scale of a large Postal facility. · Because HVAC systems are not designed to circulate all of the air in a building, anthrax spores may not enter the high tech system before being inhaled by employees. · HVAC systems are designed to heat and cool a building and are not designed to move ALL the air through the filtration system on a regular basis. Anthrax spores could remain airborne for hours or even days before being entrained into the return duct. · Since high efficiency filters have a greater pressure drop, duct and fan modifications will probably have to be made to each building at significant dollar and energy costs. · Since all buildings are different, the modifications for each building will have to be engineered separately. Environmental Issues No environmental issues have been identified. The environmental impacts of the technologies being considered will vary. Enhanced filtering will be environmentally friendly, although the appropriate disposal of filters will need to be defined. Costs Cost estimates will be developed after this study is completed. Operational Operational considerations will be presented as a result of the study in progress. Viability in the USPS Environment The possibility that airborne anthrax spores can be trapped and possibly killed in the heating, ventilating and air-conditioning (HVAC) systems in postal buildings is being specifically evaluated in a feasibility study, as indicated above. From this study, viable alternatives, if any, will be selected for prototyping by the end of FY-02. C.3 HEPA Cleaning Systems Technical Description The cleaning procedure of blowing out mail processing machines with compressed air was discontinued in October of 2001. The use of vacuum cleaners is now the method of choice for routine cleaning of equipment and surfaces. Consultation with Postal Service Certified Industrial Hygienists (CIH) and CIHs from the Logistics Management Institute (LMI) confirmed that conventionally filtered vacuums might allow the small anthrax spores to pass through a conventional vacuum cleaner's filter and be aerosolized. Fortunately, high efficiency particulate air (HEPA) filtered vacuums are commercially available and will be most efficient at capturing any spores that might enter the vacuum cleaner as a result of cleaning mail processing equipment or building surfaces. Availability/Development Status The decision was made to procure HEPA vacuums at the Headquarters level because: · Potential vendors are more responsive in production, quality, and price to large national buys than to requests from many Postal entities. · Logistic issues, specifically spare parts and consumable items, could better be handled under larger contracts. The decision to procure nationally does not prevent offices from buying additional HEPA vacuums with local funds, if desired. · Because of the urgency of the need, Purchasing contracted for over 9,000 vacuums that were already on the shelf or could be produced very quickly. These were in the field by mid to late January. · Vacuums that have to be manufactured will be deployed by the end of March 2002. The process for choosing the appropriate make and model was as follows: · Engineering developed an initial specification for HEPA vacuums that will define Postal requirements. · A cross-functional team from Engineering, Purchasing, and LMI began reviewing HEPA vacuums from major manufacturers. · The specifications were further refined and expanded. · The team wrote detailed specifications for each acceptable model that included part numbers and quantities for accessories, consumable items, and repair parts. · LMI and Engineering continued to review additional HEPA vacuum equipment. By the end of March when this program is complete, approximately 9050 facilities, which are 5,000 square feet in area and larger, will receive at least one HEPA vacuum. Facilities over 25,000 square feet will receive approximately one vacuum per 20,000 square feet. Approximately 16,000 HEPA vacuums will be purchased at a total cost of approximately $12.6 million. The 5,000-square foot limit for facilities receiving vacuums was established because offices smaller than this do not have mechanized equipment that will likely cause the mail to expel anthrax spores. There are approximately 25,000 of these smaller offices. The total cost to provide each of these offices with a HEPA vacuum will exceed $20 million and will not significantly increase employee protection. Product/Procedure-Specific Information HEPA vacuum cleaners are available in a wide variety of prices and applications. The process for choosing the appropriate make and model for postal needs is outlined under Availability/Development status above. Effectiveness The primary advantage of using HEPA vacuums instead of dry sweeping and cleaning with compressed air is their ability to trap anthrax spores. Additional advantages include: · Less airborne dirt in the facility resulting in fewer employee complaints. · Significantly less dust settling on the floors and other surfaces that has to be removed again. · Reduced energy consumption and noise compared to compressed air cleaning. Disadvantages of HEPA vacuums include: · Possible less efficient mail processing equipment cleaning, which may result in degraded performance. · A perceived increase in the time and labor required to clean equipment. · Additional cost for consumables (filters etc.) and maintenance. Environmental Issues No environmental issues in the use of HEPA vacuum cleaners have been identified. Costs 15,020 HEPA vacuums will be purchased at a total cost of $12.6 million. Operational Dry sweeping and cleaning with compressed air, which until recently were standard practices in the Postal Service, have been banned to prevent aerosolizing anthrax spores. Only vacuuming and wet methods can be used. Potential operational impacts of the use of HEPA vacuums include: · Possible less efficient mail processing equipment cleaning, which may result in degraded performance. · A perceived increase in the time and labor required to clean equipment. · Additional cost for consumables (filters etc.) and maintenance. Viability in the USPS Environment This technology has been implemented. Effectiveness and impact will be monitored. Appendix D Detection D.1 Introduction Following the Postal Service's first notification that letters containing anthrax had been sent through the mail, the Postal Service formed a task force that has been actively pursuing acquisition of biohazard detection and identification systems. The following four-step plan was constructed to guide the task force: (1) perform a technology scan to determine any existing systems deployed and available; (2) assess feasibility of technology in postal environment; (3) contract and conduct testing; and (4) choose and recommend most appropriate technology(ies). D.2 Factors that Determine the Ability to Detect Contamination Given a scenario in which a contaminant is placed into a mailpiece that subsequently enters the mail stream, a variety of factors may affect the ability to detect the contaminant. These factors include the following: · Quantity of contaminant in the mailpiece · Type of contaminant (species of organism, etc.) · Physical form of contaminant · Integrity/porosity of mailpiece · Handling of mailpiece · How sampling/detection is conducted (active, passive) · Where in the process sampling/detection is conducted · When/how frequently sampling/detection is conducted · How sampling/detection is performed (specific vs non-specific, sensitive vs non-sensitive) It must be recognized that no detection technology will work 100 percent of the time, and that the specifics of any scenario could result in even a highly effective technology failing to detect a contaminated piece of mail. The challenge will be to engineer into the mail processing system an appropriate set of detection technologies that offer a maximum probability of detection contamination when it occurs, within the constraints imposed by the system itself and the limited funds available. D.3 Screening Process Under the auspices of the President's Office of Science and Technology Policies (OSTP), the Postal Service has been aided in evaluating technology by several agencies. The OSTP immediately formed a subgroup, which includes leading scientists in biohazard detection, to aid the Postal Service. The group has met on multiple occasions to discuss different technologies and their feasibility in the postal environment. Also, the Joint Program Office for Biological Defense, a Department of Defense agency, has been extremely helpful in evaluating which military technologies could potentially be applicable for our use. The overall screening process of technologies has in large part been done using the experts from the agencies listed above. A short list was put together of the best potential military technologies from all the technologies the Joint Program Office for Biological Defense has evaluated. However, the Postal Service has received hundreds of calls regarding other technologies from research laboratories, universities, and firms that have products being used in hospital pharmacies and food processing. The following criteria were used to determine whether these technologies could have potential: (1) Is the product currently available?; (2) Could it be produced in the quantity the Postal Service needs, and in the short time frame required (looking for technology that can be rolled out in the next year)?; (3) Are any data available on sensitivity level and false positive rates?; and (4) What range of threats would it be capable of detecting (microorganisms, toxins, chemical, etc.)? Most of the technologies being solicited were still in research and development and not deployable in the near future. Applications evaluated included several premature usages of mass spectrometry or flow cytometry, new concepts using ultraviolet or laser technology, systems using microchips, a technology that used X-rays to look inside letters, and a myriad of other potential applications. The systems listed above were either not ready, or would not work in our environment. D.4 Technology Under Consideration The state of biodetection technology is rapidly developing and the Postal Service will continue to look for new technologies that can identify biological hazards. At this point in time, the Postal Service has identified the following products as having significant potential: · Biological indicator strip (provides a visual indication of the presence of biological agents in envelopes or other postal containers) · Air particulate monitoring technologies for use in major processing and distribution centers - Particle counter - Particulate shape analyzer - Laser discriminator · Biohazard signature testing (either as a confirmation to air particulate monitoring, or for periodic sampling and analysis of airborne particulates) - Immunoassay test strip - Integrated air sampling/sample prep/polymerase chain reaction assay system · Air particle concentrator interfaced to a mass spectrometer, for use in major processing and distribution centers. A possible alternative to particulate monitoring and confirmation testing Below is a detailed description of each of these categories of technology. D.4.1 Biological Indicator Strip Technical Description The Biological Indicator Strip is a strip 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 two compounds found in bacteria of the genus Bacillus and several others. The technology was originally conceived for bacterial testing in the food industry. Its potential application as part of the United States Postal Service (USPS) 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 possible to be deployed at collection boxes. The anthrax spore has one major chemical signature that is detected by the Indicator Strips. This major chemical signature is dipicolinic acid, which is found in bacterial spores. Bacteria are grouped into two basic types-either Gram positive or Gram negative-as a function of the cell wall chemistry. A Gram positive stain can produce bacterial spores. Bacterial spores are a highly specialized, dormant form of the organism that forms when conditions are unfavorable to growth. Spores are resistant to relatively high degrees of heat, chemicals, and radiation, and have a unique compound-dipicolinic acid-that reacts with a reagent on the Indicator Strip to produce a color change. A positive test result on the test would indicate the possibility of anthrax contamination. However, this test is not specific for anthrax, and confirmation testing will be needed following a positive result. Other kinds of Bacillus spores are widely and commonly found in the environment, and could also give a positive reaction if present in sufficient quantities. While one would not expect that the mail would contain high levels of bacteria, the practicality of this technology in the USPS environment remains to be demonstrated. Availability/Development Status A test strip is available off-the-shelf that has three independent visual tests. These are a dipicolinic acid spore test (as described above), a gram-negative organism test (based on presence of the biomarker Lipid A in cells), and a vegetative cell test (based on a pH change from cell growth). The technology is probably not readily applicable to such threat agents as toxins and viruses. The lead-time for large quantities is not known, nor is the availability prototypes of indicator strips of other kinds, that could be used for other bioterrorism agents. Product/Procedure-Specific Information The technology was conceived for use in food production in industrial settings. The manufacturer is proposing incorporation of the strips into the USPS mailing environment. The item is disposable, so there are no maintenance issues. Its shelf life is not known. Effectiveness There is a concern over the sensitivity level of these strips. If a large quantity of spores is needed to obtain a positive test result, the potential applicability of the technology could be much more limited. Detection of airborne spores may require an aerosol collector front end. The strips are not specific for anthrax and will give a positive result with some relatively common and benign bacteria of the Bacillus family. A positive result on this test will require confirmation by a more specific and reliable test using PCR or a laboratory-based immunoassay. The device is FDA listed as a class 1 microbiology-testing device. The availability of data on performance, utilization in current applications, and limitations on its use are not known. Environmental Issues Not a significant factor. Use of this technology will have small but significant facility impacts (primarily storage and personnel). Positive test strips will have to be disposed of properly, but this will be done in the context of remediation of contaminated mail or facilities. Costs The indicator strips are estimated to cost less than $1 per test. Overhead for their use is expected to be minimal, as the items are disposable, but allowance must be made for the logistics of stocking and distributing strips to points of use, and for recording test results. Operational Several kinds of operational impacts will be expected to result from use of the indicator strips. In some situations the use of indicator strips may require interruption of processing operations. Some specialized uses of the strips may require swipe or air sampling to be performed, for which training will be needed. Also, if deployed routinely in collection boxes or personnel monitoring badges, mail carriers and other affected personnel will have to learn how to use the devices properly and what actions would be taken upon obtaining a positive test result. If the indicator strips are deployed to "integrate" over time (i.e., collect biohazardous agent cumulatively and give a color change after some threshold value is exceeded), they will have to be changed out on a fixed schedule. Being disposable, there are not expected to be any maintenance issues. Viability in the USPS Environment If it performs as expected, the indicator strip can help the USPS rapidly identify the possibility of 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 lack of specificity of this technology could give an unacceptable number of false positives. The indicator strips are expected to be compatible with testing in USPS environments without restriction. To qualify this technology for USPS applications, the following information gathering steps need to be taken: (1) determine the availability of indicator strips in quantities required by USPS; (2) determine what kinds of test strips have been developed, what kinds of biohazards are covered by them, and what the lead time would be for developing additional kinds of test strips; (3) determine the sensitivity of the test strips; and (4) perform testing to determine the likelihood of false positives within the postal processing environment. D.4.2 Particle Counter Technical Description A particle counter 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. Particle counters work by continuously sampling air at a given location, sorting particles into separate streams by size range, and counting the particles in each stream. Typically the device focuses a laser beam on a collimated stream of particles and detects attenuation of the beam by individual particles. It compares readings at a given point in time with a previously established baseline. Availability/Development Status Particle counters are widely available as commercial-off-the-shelf items. The lead-time for a large quantity such as will be required by USPS is not known. Product/Procedure-Specific Information Particle counters are typically used in labs and industrial settings where airborne particles pose a risk to human health and/or product quality. They are precision instruments that require periodic maintenance and calibration, although the exact frequency is not known. Effectiveness This technology, or variants of it, has been certified and performance measures are available. Continuous operation of particle counters is required in some industrial settings by occupational safety and health regulations. A major concern about the effectiveness of this technology is that the postal processing environment has a very high background level of particulates. There has been no determination that a particle counter/sizer can effectively identify bacterial spores or other kinds of bioterrorism threats against this high background of particulates. Further testing, and improvements, in the postal environment will be required to demonstrate this capability. Another consideration that especially applies to the particle counter is that dry bacterial spore preparations, even of 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 to identify the presence of biological contamination. Environmental Issues No environmental, safety or health constraints would be expected to be associated with the use of a particle counter. Maintenance personnel may need to use caution or personal protective gear if encountering accumulated dust within the device. Costs Capital costs are approximately $5,000 per unit for a representative device. Up to 2000 units could be needed to cover the major processing and distribution centers. Life cycle (operation and maintenance) costs are not known, but may be significant. Other types of costs are expected to be insignificant. Operational The most likely place of deployment will be in major processing and distribution centers, and the most likely equipment that will be fitted with a particle counter will be the Advanced Facing and Canceling Systems (AFCS), since the AFCS is one of the first points in the mail processing flow for mechanical disturbance of mailpieces. Operation and maintenance of this equipment will require nominal but significant training and expertise. Requirements for maintenance are not known, but the device may require frequent cleaning. Viability in the USPS Environment The technology may be able to satisfy USPS requirements for ongoing monitoring of airborne particulates released from mailpieces during automated handling and sorting operations. It will be placed at the earliest points in the mail handling process where mechanical forces are likely to cause release of substantial amounts of spores from a piece of mail. This is a fairly low technology solution to the problem of identifying anomalous particles, and may not be sufficiently sensitive to identify the presence of microorganisms at useful levels in the context of the high particulate background. 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 a release of bacterial spores at potentially hazardous levels in the postal processing environment. Testing in an operational setting demonstrated there was difficulty with high background particle loading and the ability to detect the release of small amounts of surrogate agent spores under these conditions. D.4.3 Particulate Shape Analyzer Technical 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 from 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 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 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. Particles in a continuously sampled stream of air are collimated and deposited on a moving surface that passes through a strobe-illuminated microscope. Images of individual particles are captured, stored, and analyzed using image analysis software and statistical functions. Availability/Development Status Particulate shape analyzers are commercial off the shelf items from a small number of vendors. The lead-time for a large quantity such as will be required by USPS is not known. Product/Procedure-Specific Information 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. They are precision instruments that require periodic maintenance and calibration, although the exact frequency is not known. Effectiveness 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. It has not been proven that a particle shape analyzer can effectively identify bacterial spores or other kinds of bioterrorism threats against this high background level of particulates. Our assessment of the technology suggests that it difficulty in this environment. There are no known constraints on the use of the device. Environmental Issues No environmental, safety or health constraints will be expected to be associated with the use of a particle counter. Maintenance personnel may need to use caution or personal protective gear if encountering accumulated dust within the device. Costs Capital costs are approximately $50,000 per unit for a representative device. Up to 2000 units could be needed to cover the major processing and distribution centers. Life cycle (operation and maintenance) costs are not known, but may be significant. Consumables may be required for the operation and maintenance of the device. Other types of costs are expected to be insignificant. Operational Use of this technology will not require significant retrofitting of postal processing equipment. The most likely place of deployment will be in major processing and distribution centers, and the most likely equipment that will be fitted with a particle counter will be the (AFCS, which is the one of the first opportunities for mechanical disturbance of mailpieces at the centers. Operation and maintenance of this equipment will require nominal but significant training and expertise. Requirements for maintenance are not known, but the device may require frequent cleaning. Viability in the USPS Environment This technology will have to be further modified to satisfy USPS requirements for ongoing monitoring of airborne particulates released from mailpieces during automated handling and sorting operations. It will be placed at the earliest points in the mail handling process where mechanical forces are likely to cause release of substantial amounts of spores from a piece of mail. However, it appears that this technology is not sufficiently selective to reliably identify the presence of microorganisms at useful levels in the context of a high particulate background. Additional modification of the technology is needed. Critical to the usefulness of the technology is that it be demonstrated to be able to positively identify a release of bacterial spores at potentially hazardous levels in the postal processing environment. D.4.4 Laser Discriminator Technical 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. There are several variants of this device under pilot production that 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. In one variant of this technology, a stream of air containing particles is passed through a flow cell illuminated by a laser beam. Using sophisticated optics, light emitted at right angles from the incident beam is captured, separated into fluorescence and scattering signals, and quantified using photomultiplier tubes. Availability/Development Status Laser discriminator technology is a continuously emerging technology. Several developers currently have variant products available. The lead-time for the large quantity of devices that will be required by the Postal Service will depend on the developer. Improvements in laser and optics technology could significantly improve the performance of laser discriminators, but this will require additional development before achieving a deployable device. Product/Procedure-Specific Information 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. Effectiveness A major concern about the effectiveness of this technology is that the postal processing environment has a very high background level of particulates. There is no current proof that a laser discriminator can effectively identify bacterial spores or other kinds of bioterrorism threats against this high background level of particulates. 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 a high particulate level background. There are no known controls or constraints on the use of the device. Environmental Issues No environmental, safety or health constraints would be expected to be associated with the use of a particle counter. Maintenance personnel may need to use caution or personal protective gear if encountering accumulated dust within the device. The device uses a laser in an enclosure. Precautions and/or safety controls will be applied to reduce the likelihood of eye damage to equipment users or service personnel. Costs Capital costs are approximately $50,000 per unit for a representative device. Up to 2000 units could be needed to cover the major processing and distribution centers. Life cycle (operation and maintenance) costs are not known, but may be significant. Other types of costs are expected to be insignificant. Operational The most likely place of deployment will be in major processing and distribution centers, and the most likely equipment that will be fitted with a particle counter will be the AFCS, which is the one of the first opportunities for mechanical disturbance of mailpieces at the centers. Operation and maintenance of this equipment will require nominal training and expertise. Requirements for maintenance are not known, but the device may require frequent cleaning. Viability in the USPS Environment With additional development, this technology may be able to satisfy USPS requirements for ongoing monitoring of airborne particulates released from mailpieces during automated handling and sorting operations. It will be placed at the earliest points in the mail handling process where mechanical forces are likely to cause release of substantial amounts of spores from a piece of mail. This technology may not be sufficiently selective to reliably identify the presence of microorganisms at useful levels in the context of the high particulate background. Additional testing of the technology is needed. Critical to the usefulness of the technology is its demonstrated ability to positively identify a release of bacterial spores at potentially hazardous levels in the postal processing environment. D.4.5 Immunoassay Test Strip (Lateral Flow Immunochromatographic Assay) Technical Description The immunoassay test strip is a small (matchbook-sized), 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 optionally 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 USPS as a possible confirmation test to follow a positive trigger with the air particle monitoring technology. The strip contains reagents to conduct a sandwich immunoassay for the target analyte. The analyte reacts with an antibody-coated silver particle, and is carried along a porous strip by the carrier liquid containing the sample. A second antibody reaction immobilizes the analyte-bearing silver particles at a specific location on the strip, at which (if analyte is present) they become visible as a dark band. A second, control reaction is also carried out, to verify proper functioning of the strip. Availability/Development Status Immunoassay test strips are currently in production. Also available as off the shelf items are a benchtop device for automated aerosol capture into a liquid sample for introduction into a test strip, and a benchtop device for automated test strip readout. Immunoassay 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 that some antibodies may not be species specific. Any selected test strips will be evaluated against organisms present in the background. If additional assays were required, substantial lead-time could be required to produce antibodies and develop the tests. An alternative and somewhat less mature variant of this technology uses upconverting 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 DNA amplification and lateral flow assays to identify organisms. Product/Procedure-Specific Information Immunoassay test strips are recommended for testing of environmental liquid and swab samples. The items are disposable and designed for one time use only. Their long-term storage potential is not known but the item is believed to have a reasonable shelf life. A built-in control assay helps identify malfunctioning test strips and provides greater confidence in a negative result. In spite of this, the uniformity of the items is not known and will need to be determined and documented. When an immunoassay test strip, or any other technology, is used to test manually collected samples, the precise strategy for how and where to collect samples becomes an overriding factor. A negative test result for an improperly collected sample may prove unreliable even when the underlying detection technology is working properly. Maintenance is a potential issue with the air sampler and strip reader devices, and could be a significant factor in terms of material and labor costs. Effectiveness The device produces a test result within 15 minutes following application of a sample. There is concern about the level of sensitivity for most applications. The specificity of the antibodies in the test are an issue-not all tests that are nominally for a given organism are equally specific, and one would compare vendors 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. 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. 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 still a concern because of the underlying sensitivity of the strip. Environmental Issues There are no known environmental or occupational constraints on the use of the test strips. There are no added personnel risks above those caused by the presence of contaminants being tested for. If contamination is found, used strips may require handling as a biohazard. Costs As expendibles, 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. Benchtop 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. If on the other hand, they are used for primary testing, then their usage rate will be much higher and the overall cost will increase accordingly. Operational 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. The sampler device may have to be interfaced with air monitoring systems if used, or directly to mail processing equipment. Training is required for proper collection and preparation of samples and their application to the strips, and for proper operation and maintenance of the sampler and reader devices. Viability in the USPS Environment This technology is not believed to have high potential value to USPS efforts to secure its facilities and personnel against contamination by infective agents. The application of confirmation testing of airborne particulates on process lines at major mail processing and distribution centers requires reliability not demonstrated by these strips. It will be associated with anonymous mail process lines involving physical stresses on mailpieces that could result in release of pathogenic organisms. It could also be used in other parts of the mail processing system as a test of possible contamination, but sensitivity is a big issue. D.4.6 Integrated Air Sampling/Sample Preparation/Polymerase Chain Reaction (PCR) Assay System Technical 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, pathogenic agents, human DNA, interspecies relationships, etc. In the context of USPS requirements, it is envisioned as a primary or confirmation test that will 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. The sample is mixed with test reagents, either manually or automatically in a cartridge. A precision instrument subjects the mixture to a precise series of heating and cooling cycles. Each cycle causes each copy of the test sequence that is present in the sample tube to form a replica of itself. These replicas in turn are also replicated; giving a chain reaction that quickly builds up a large quantity of the replication product. Each replication step is accompanied by generation of a highly fluorescent dye molecule, which is detected optically. Availability/Development Status PCR is a mature technology that has a wide variety of experimental and commercial variants. Benchtop thermocyclers are available in some variety of designs, some of which employ an integrated microfluidic cartridge that automates most of 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. New assays if required may involve a substantial development effort. Selection of sequences for effective primers and probes for a new PCR test is not straightforward and considerable testing is required to design optimal reagents and validate the new test, however, a wide range of tests are currently available. Product/Procedure-Specific Information PCR is used for testing of clinical, forensic, and environmental samples of all kinds. USPS envisions it for use in testing airborne particles released as mail is handled by automated processing equipment. Maintenance requirements for the specific devices under consideration are not known. Thermocycling instruments do require periodic maintenance, but it is not expected to be a major cost or labor factor. The air sampling device may also require maintenance. Uniform performance is assured by calibrating each analytical run. Each run includes a number of standards (spikes and blanks), and a standard curve is generated for each run. This helps assure reproducibility. Effectiveness PCR generally is an extremely sensitive assay method and can routinely detect as few as 50 copies (organisms) per sample within 15-30 minutes. 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. PCR has been certified for clinical testing. PCR evidence of genetic relationships is frequently used, and accepted, as evidence in court cases. Performance measures are generally widely available for both instruments and for complete assays. Performance measures are typically required as part of the development process for a new assay. PCR technology is well known and widely used at present. An important factor is sample throughput, which varies from one instrument to the next as a function of the number of readout ports on the device and the ability of the instrument to independently thermocycle individual samples. In the latter case, one could analyze for multiple analytes at the same time (using separate cartridges following different thermal cycling programs). One can also use multiplex assays, which enable more than one analyte to be tested for in a single reaction tube or cartridge. There is a potential for cost savings over separate individual assays, but multiplex assays are usually not as sensitive. Environmental Issues There are no known environmental or occupational constraints on the use of the PCR cartridges. There are no added personnel risks above those caused by the presence of contaminants being tested for. If contamination is found, used cartridges may require handling as a biohazard. Costs The cost per assay, labor and materials will run in the $10s to $100s range, depending on assay format, use of cartridges, etc., with costs expected to be lower in high volume. Research grade benchtop thermocycling devices are in the range of $50,000 - $100,000 in capital outlay, portable and handheld versions are less costly. Up to 2000 thermocyclers could then 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 $3000 each. Life cycle costs for these devices are not known, but could be significant. Improvements to technology may outpace instrument longevity. If the PCR cartridges 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. If on the other hand, they are used for primary testing, recurring costs will be relatively expensive. Operational 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 device. Also, 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 be interfaced with air monitoring systems if used, or directly to mail processing equipment. Viability in the USPS Environment This technology is believed to have high potential value to USPS efforts to secure its facilities and personnel against contamination by infective agents. It is expected to be used in primary or confirmation testing of airborne particulates on process lines at major mail processing and distribution centers. It will be associated with anonymous mail process lines involving physical stresses on mailpieces that could result in release of pathogenic organisms. It also can be used in other parts of the mail processing system as a test of possible contamination. The technology is fairly well understood. However, low levels of analyte, the possible presence of inhibitors and other interferents with the assay, and integration with the process are negative factors but these are being overcome. It is much more sensitive than the immunoassay test strips. It is more flexible than the test strips (new assays can be added relatively easily) but more costly per test. D.4.7 Air Particle Concentrator/Mass Spectrometer MALDI-TOF-MS (matrix assisted laser desorption ionization-time of flight-mass spectroscopy) is one variant that has been studied extensively relative to the BW agent detection problem. Technical 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 to identify chemical unknowns and verify 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 US Postal Service 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. The mass spectrometer uses specially developed technology such as matrix-assisted laser desorption to convert high molecular weight cellular components into ionized particles with high efficiency. It uses a combination of electric and optionally magnetic fields to separate particles in a vacuum by their mass to charge ratio. Particles are detected on a cathode and measured as a current flow. The mass spectrum is a plot of ion abundance as a function of mass. Software then can be used to try to match the mass spectrum of a sample against a library of mass spectra of known substances, to make positive identification. This problem becomes more difficult if one is analyzing a more complex mixture, such as a living organism, and requires more sophisticated pattern recognition approaches. A variant of this technology, known as ion mobility spectroscopy, uses rate of diffusion through a low pressure inert gas as a means to separate ions. Availability/Development Status Research mass spectrometers are widely available commercially. The integrated air sampler-biological mass spectrometers being considered for USPS deployment are in pilot production and have limited availability. There will be a long lead-time expected for acquisition of a large number of devices (as will be needed for deployment in major processing and distribution centers). Product/Procedure-Specific Information 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. The maintenance overhead for the devices under consideration is not known, but maintenance is probably a significant factor. Mass spectrometers can be high maintenance instruments that require frequent calibration. However, sophisticated control systems may partially automate calibration. Factors related to long term utilization and storage, and quality control are not known for the prototype under consideration, but are probably not significant. Effectiveness 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, and possibly as grown under a variety of 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 will encounter in a mail-processing environment. Mass spectrometers have been tested and certified for military and forensic applications, especially in identification of trace levels of chemical substances, and its application to biological macromolecules such as proteins and DNA fragments has become nearly routine. The particular hardware under consideration and its expected application within the postal system is quite new and few specific data if any are available on its ability to meet USPS requirements. Environmental Issues A particle concentrator/mass spectrometer will require maintenance on a regular basis, but the risks posed to maintenance personnel are not expected to be significant. The device will require space and power, but at levels far below those required by the processing and sorting equipment, and probably can be accommodated within the constraints of the existing infrastructure, although the equipment will have to be retrofitted. Costs The devices under consideration are expected to come in with initial capital costs of about $150,000 each (approximately 1128 units could be needed to cover the major P&DCs). There will be nominal ongoing costs for consumables used during the operation of the device, and 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. Operational The operational considerations for implementing this technology in the USPS 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. Viability in the USPS Environment The technology may be able to satisfy USPS requirements for ongoing monitoring of airborne particulates released from mailpieces during automated handling and sorting operations. A critical issue here is whether it can function effectively given the high level of particulates expected in this environment. The technology is in prototype/pilot stage and may be available in a timeframe acceptable to USPS, but if so it will be only 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. Also it is critical that it be shown to work in a postal facility in the presence of the typical load of particulates found there. Appendix E Intervention This appendix summarizes the evaluation of technologies for intervention of contamination before contaminated mail enters the system. The mode of intervention that is being evaluated and applied is the bulk sterilization (killing of all live organisms present) of mail prior to its entry into processing. The sterilization technologies evaluated fall into two basic categories, irradiation and chemical. One additional physical method, high-pressure sterilization, is evaluated. Irradiation technologies include: · Electron Beam · X-rays · Gamma Rays · Ultraviolet (UV) light · Microwave The first three of these technologies are evaluated together under "ionizing radiation" because of their logistic similarity. Chemical technologies include: · Chlorine Dioxide · Ethylene Oxide · Methyl Bromide · Ozone These technologies are also evaluated for decontamination of facilities in Appendix E. E.1 Ionizing Radiation-Electron Beam, X-ray, Gamma Ray Companies that provide this equipment and/or services include Titan/Surebeam, Ion Beam Associates, Rad Source Technologies, Inc., MDS Nordion, Steris Corp., NUTEK Corp., and duoTEK, Inc. Technical Description Ionizing radiation relies on the deposition and absorption of energy at the molecular level. The absorbed energy breaks chemical bonds, destroying essential chemical structures and resulting in reactive ions and free radicals, which cause additional damage. Damage to deoxyribonucleic acid (DNA) and cellular proteins required for a cell to survive and reproduce results in the death of cells, including infectious organisms. There are three technologies for producing ionizing radiation that are currently considered for use in mail sanitization via irradiation. These are: Electron Beam (e-beam), X-ray, and Gamma ray (?-ray). An e-beam is a beam of electrons driven by a high accelerating voltage, similar to the beam of electrons generated in a television picture tube. The accelerating voltage determines the energy "content" of the driven electrons. At sufficiently high energies, these electrons sterilize biological materials by reacting with the DNA and proteins of cells. The result is a biological particle that has lost the ability to reproduce and is thus non-infectious. Because the beam of electrons loses some of its energy as it interacts with the material it is sent through, there is a finite "thickness" of material that can be treated to effect sterilization. X-rays are high-energy electromagnetic radiation. X-ray photons are generated by bombarding electron-dense materials with high-energy electrons. These X-ray photons can be focused and directed with mirrors and they contain energy that can interact with biological materials. In sufficient quantity, X-rays can disrupt nucleic acids of cells, leading to cell death. As noted, X-rays can also damage proteins by generating reactive free radicals. Because of their higher energy content, X-rays can penetrate materials more easily than e-beam electrons. Gamma ray systems are functionally similar to X-rays and e-beams but are the most energetic portion (shortest wavelength) of the electromagnetic spectrum. They are generated by the decay of radioactive sources such as cobalt 60 or cesium 137. Gamma rays are even more powerful and have an even higher penetration capability than X-rays. All three irradiation technologies are currently used to sterilize medical equipment and for food "pasteurization." Irradiation technology is of potential use to the United States Postal Service (USPS) because it provides the capability to penetrate sealed envelopes in a relatively non-destructive manner, allowing for the sterilization of both the contents and the wrapper or envelope of an item of mail. Availability/Development Status Of the three-irradiation technologies available, only e-beam is immediately available with a capacity to handle the Postal Service needs. While both X-ray and gamma ray technologies have demonstrated the capability to destroy B. anthracis, neither is immediately available on the scale required by the USPS. USPS identified two CONUS sources of e-beam accelerators. The use of e-beam technology was implemented in October 2001. Contracts have been awarded for off-site e-beam sterilization of mail from the Brentwood and Trenton facilities and incoming government mail for Zip Codes 202-205. USPS purchased eight e-beam systems to install in the Washington, DC and Trenton, NJ areas. Preliminary plans call for four systems to be installed and ready for use in the Washington, DC area. The irradiation facility layout and design is near completion; the appropriate approval and permitting process will be followed. In turn, public notification will be a critical component of our plans to move forward. The site for the other four systems is still being worked. Product/Procedure-Specific Information All three irradiation technologies are currently used to sterilize medical equipment and for food "pasteurization." The e-beam process has been in use for high throughput uses such as the sterilization of foods on a factory-scale, and has been adapted to process mail. It does not need a radioactive source to generate the high-energy electrons, but does require significant electrical supply and sufficient shielding while the beam is on. The process can be semi-automated. Costs of the process depend on whether mail can be sorted sufficiently to ensure that only items of sufficient risk to merit sterilization are treated in this manner. Other cost drivers include capital cost of equipment, capital costs of facilities (the shielding of the units requires a foundation that can withstand ~45,000 lbs per sq. ft.), and energy costs. Since irradiation technologies have never been used in applications similar to USPS requirements, current knowledge gaps include maintenance issues and performance issues. Effectiveness All three technologies have demonstrated the capability to effectively destroy B. anthracis. However, due to the amount of energy transferred to the mail by any of the irradiation processes described, all three technologies could damage certain types of mail, including film, electronic equipment, and live samples such as seeds. All three technologies will affect mail service and make the handling of mail more difficult and time consuming. Gamma ray technologies, in addition, require specialized handling procedures for the radioactive source. E-beam has been shown to be effective in the eradication of biohazards. In order to assure immediate effectiveness, energy levels on the high end were used. The downside of high energy input is the greater likelihood of unacceptable damage to the mail. Because physical changes occur in irradiated material, mail processed in this manner may have different organoleptic properties after processing than before-paper is embrittled, plastics yellowed and hardened. As operational experience is gained in the real time application of this technology, the energy levels can be fine-tuned to continue to achieve complete threat eradication while minimizing the possibility of effects on certain mail items. Performance evaluation designed to identify the lowest range of energy that will assure adequate killing of the relatively resistant anthrax spores with the minimum of damage to the mail will be important if e-beam technology is to be more widely and uniformly applied to mail processing. Another issue in the effectiveness of irradiation technologies is the possibility of materials within the mail that are opaque to radiation. Such materials could shield portions of the mail from the radiation and allow biohazards to survive the treatment. This issue is being resolved by irradiating from multiple directions or by turning the mail as it passed through the irradiation chamber. Environmental Issues All three technologies have been successfully permitted for other applications. A knowledge gap exists as to the specific environmental regulations with which the USPS will have to comply. However, it is highly likely that the manufacturers of the technologies will have experience in this area and will help the USPS comply with relevant regulations. There may be constraints on the use of irradiation technology due to public concerns as to the effect of irradiation on mail and its contents. Costs For implementing e-beam processing in Postal Service facilities, the following estimates have been developed: Purchase of 8 e-beam systems for servicing of two centers-$40.2M Service contracts-$2.5 M/month for servicing of 8 e-beam systems Equipping of all Processing and Distribution Centers Solution (350 Sites)-$2.25B Equipping of Centralized locations (100 Sites)-$750M to $1B All three technologies are expected to be expensive and have recurring costs. Utility costs are expected to he high with all three technologies. X-ray technology will provide the highest utility costs due to the fact that X-ray producing equipment has only 5-8 percent of the power efficiency of e?beam technology. Gamma ray technology may present recurring costs related to the radioactive fuel sources. Fuel may be limited, especially in quantities large enough to meet USPS requirements. Operational A large and heavy footprin