E54.01 - CBRNE Detection and CBRN Protection

SCOPE
1.1 This specification provides system designers, manufacturers, integrators, procurement personnel, end users, practitioners, and other responsible authorities with a common set of criteria to match field screening device capabilities with user requirements for specific applications.  
1.2 This specification describes the required test sample compositions and amounts, and provides a statistically-based testing approach for evaluating FSD performance for the detection of biological agents as described in Test Method E3395. This specification does not address the estimation of limit of detection.  
1.3 Units:  
1.3.1 Values stated in SI units are to be regarded as standard in this specification.  
1.3.2 When creating test sample mixtures, all concentrations are stated as copies/mL or genome equivalents/mL (GE/mL).  
1.4 Operational Concepts:  
1.4.1 FSDs used for identifying potentially dangerous biological agents play an important role in the decision-making processes intended to protect responders and the general public. Suitable FSDs require low rates of false positives and false negatives. FSDs are used for surveillance and sample screening, and they are a particularly important tool in responding to incidents where a sample suspected of containing a biological agent is found. FSDs must be rugged enough to withstand storage and operating conditions that include, but are not limited to, temperature and humidity extremes, shock and vibration, radio frequency interference, and rapid thermal and humidity changes. This specification does not address testing to characterize operating limits or storage conditions.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Manufacturers, purchasers, and end-users will need to determine safety requirements including, but not limited to, use by hazardous material (HAZMAT) teams; use with personal protective equipment (PPE); use by firefighters, law enforcement officers, or the Federal Emergency Management Agency (FEMA) Urban Search & Rescue (US&R) teams, special electromagnetic compatibility needs, extended usage periods, and extended mission time.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 Prompt and accurate identification of harmful biological agents on-scene is crucial to decision making for taking action and responding to incidents involving biological agents.  
5.2 The detection and identification of a biological agent will inform how responders prepare for on-site activity (for example, selection of PPE and necessary precautionary actions), treat exposures, secure and decontaminate the incident site, and inform follow up actions to be taken after the incident has occurred.  
5.3 Inclusivity and exclusivity test panels are used to ensure that biological agents targeted by the FSD can be detected (inclusivity) and that biological agents not targeted by the FSD are not detected (exclusivity). The environmental test panel is used to determine if there are potential interferences that could result in a false negative result when spiked whole biological agent is present.
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1.1 General:  
1.1.1 This test method provides a procedure for characterizing the performance of nucleic acid-based field screening devices (FSDs) for the detection and identification of biological agents, when utilizing the test samples and statistical considerations described in Specification E3394.  
1.1.2 This test method describes sample preparation and analysis protocols to use when characterizing the performance of nucleic acid-based field screening devices for the detection and identification of biological agents.  
1.1.3 The intent of this test method is to provide a methodology to analyze samples in a manner that is analogous to how they are to be analyzed in the field by federal and state/local/tribal/territorial (SLTT) law enforcement and first responders, but under more controlled and reproducible conditions than those generally achievable when conducting field testing. The analysis of testing results as described in this test method and in Specification E3394 allow for a systematic way of measuring the statistical performance of FSDs.  
1.2 Units:  
1.2.1 The values stated in SI units are to be regarded as standard in this document.  
1.2.2 When creating test sample mixtures, all concentrations are stated as copies/mL or genome equivalents/mL (GE/mL).  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 It is essential for response agency personnel to plan, develop, implement, and train on standardized guidelines that encompass policy, strategy, operations, and tactical decisions prior to responding to a radiological or nuclear incident. Use of this practice is recommended for all levels of the response structure.  
5.2 Documents developed from this practice should be reviewed and revised as necessary on a two-year cycle or according to each jurisdiction’s normal practices. The review should consider new and updated requirements and guidance, technologies, and other information or equipment that might have a significant impact on the management and outcome of radiological incidents.
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1.1 This practice provides decision-making considerations for response to both accidental and intentional incidents that involve radioactive material. It provides information and guidance for what to include in response planning and what activities to conduct during a response. It also encompasses the practices to respond to any situation complicated by radiation in conjunction with the associated guidance for the specific type of incident.  
1.1.1 The intended audience for the standard includes planners as well as emergency responders, incident commanders, and other emergency workers who should be protected from radiation.  
1.1.2 The scope of this practice applies to all types of radiological emergencies. While it does not fully consider response to an NPP accident,3 an explosive RDD, or nuclear detonation, detailed guidance to respond to such incidents is provided in other documents, such as those cited in the introduction. With respect to the guidance documents, this practice provides the general principles that apply to the broad range of incidents and associated planning goals but relies on the AHJ to apply and tailor their response planning based on those documents as well as the limitation of the personnel and equipment resources in the jurisdiction. In addition, the AHJ should use those documents to identify improvements to planning and resources to be better prepared for the more complex emergencies.  
1.1.3 This practice does not expressly address emergency response to contamination of food or water supplies.  
1.1.4 The Emergency Response Guide (ERG) published by the Department of Transportation provides valuable information for response to traffic accidents involving radioactive materials. For other radiological or nuclear incidents, however, the ERG may not provide adequate information on appropriate protective measures and should not be the sole resource used.  
1.2 This practice applies to those emergency response agencies that have a role in the response to an accidental or intentional radiological or nuclear incident. It should be used by emergency response organizations such as law enforcement, fire service, emergency medical services, and emergency management.  
1.3 This practice assumes that implementation begins with the recognition of a radiological or nuclear incident and ends when emergency response actions cease or the response is supported by specialized regional, state, or federal response assets.  
1.4 AHJs using this practice should identify hazards, develop a plan, acquire and track equipment, and provide training consistent with the descriptions provided in Section 6.  
1.5 While response to radiological hazards is the focus of this practice, responders must consider all hazards during a response; it is possible that non-radiological hazards may present a greater danger at an incident, particularly in incidents with wide area dispersion.  
1.5.1 This practice does not fully address assessing the risks from airborne radioactivity. Equipment to determine this potential hazard is not widely available in emergency responder communities. Like other responses to unknown hazards, respiratory protection commonly used by responders is required until a complete hazard i...

SIGNIFICANCE AND USE
4.1 This practice specifies an in-vivo measurement of CWA decontamination on the skin.  
4.2 CWA skin decontaminants will have different modes of action including absorption, adsorption, removal, chemical neutralization or some combination of the above. There is, therefore, no single representative in-vitro method for validation of decontamination efficacy of products for skin decontamination. For example, measuring the presence of a radiolabelled chemical warfare agent after chemical neutralization, may give a false positive results. It has been shown that if the agent has been chemically neutralized, the radiolabel may still be present in a non-toxic molecule. In addition, some chemical neutralization methods may break down the original agent, but the breakdown product is highly toxic. In the case of VX, hydrolysis produces a highly toxic product, EA2192 (S-(2-diisopropylaminoethyl) methylphosphonothioic acid (8).  
4.3 This standard practice is of significance in that efficacy is thoroughly evaluated to the extent possible to represent use on human skin. In-vivo studies have demonstrated that simple chemical monitoring for disappearance of the chemical agent may not be sufficient to measure decontamination and neutralization effectiveness. A standard practice is needed for determining actual decontamination and neutralization by measuring the decrease in mortality or lesion size caused by the agent.
SCOPE
1.1 This practice establishes an in-vivo method for assessing the comparative efficacy of products used for the decontamination of chemical warfare agents (CWAs) on the skin.  
1.2 This practice provides a quantitative efficacy comparison of different skin decontamination products.  
1.3 To minimize the number of animals used, this in-vivo practice should be performed only after rigorous in-vitro studies of the candidate decontaminant, which can show the implied claims including chemical neutralization, decontamination studies on surfaces and appropriate testing such as cytotoxicity.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with the use of decontamination products or CWAs. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification is used to standardize the portable water heaters used on personnel decontamination lines to insure the heaters provide sufficient heated water for as long as they are needed during the emergency. The heater materials of construction shall be easily cleaned of surface mud and grime with no degradation of the unit's ability to perform its function. The performance requirements for portable water heaters are presented in details. The rotometer test method, and ASTM test method shall be performed to meet the requirements prescribed. The water heater unit's water flow shall be measured, and recorded. The water heater unit's cold water inlet and warm water output temperature shall be measured and recorded. The water heater unit's water supply and outlet pressures shall be measured and recorded.
SIGNIFICANCE AND USE
12.1 The use of these acceptance tests will insure that organizations buying portable heaters will be assured the heaters meet certain performance requirements.
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1.1 This specification is used to standardize the portable water heaters used on personnel decontamination lines to insure the heaters provide sufficient heated water for as long as they are needed during the emergency.
Note 1: These heaters are not intended to be used for the decontamination for any other surface or material. Also, these heaters are intended to be portable and easy to use by first responders during a chemical, biological, radiological, nuclear, and explosive (CBRNE) event.  
1.2 This specification contains a specification section and a test methods section so users need to refer to the section applicable to their needs when using this standard specification.  
1.3 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.
Note 2: The U.S. first responder personnel using the equipment manufactured under this standard are not likely to be familiar with SI units so English units need to be included as part of the system documentation and shown on control panels for any equipment sold to U.S. organizations.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification is used to standardize the portable air heaters used on personnel decontamination lines to insure the heaters provide sufficient heated air for personnel comfort before, during, and after the decontamination for as long as they are needed during the emergency. The heater materials of construction shall be easily cleaned of surface mud and grime with no degradation of the unit’s ability to perform its function. The preferred fuels for the heater section of the portable air heater are diesel fuel, gasoline, or bottled propane gas. Measurement of the air heater unit’s air flow and input and output temperatures shall be performed.
SIGNIFICANCE AND USE
11.1 The use of these acceptance tests will insure that organizations buying portable heaters will be assured the heaters meet certain performance requirements.
SCOPE
1.1 This specification is used to standardize the portable air heaters used on personnel decontamination lines to insure the heaters provide sufficient heated air for personnel comfort before, during, and after the decontamination for as long as they are needed during the emergency.
Note 1: These heaters are not intended to be used for the decontamination for any other surface or material. Also, these heaters are intended to be portable and easy to use by first responders during a chemical, biological, radiological, nuclear, and explosive (CBRNE) event.  
1.2 This specification contains a specification section and a test methods section so users need to refer to the section applicable to their needs when using this standard specification.  
1.3 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.
Note 2: The U.S. first responder personnel using the equipment manufactured under this standard are not likely to be familiar with SI units so English units need to be included as part of the system documentation and shown on control panels for any equipment sold to U.S. organizations.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This guide provides information that could be used to:  
5.1.1 Establish a hazardous material instrument program;  
5.1.2 Help ensure that consistently reliable instruments are available for the detection of hazardous materials; and  
5.1.3 Provide the safety professional with the means to evaluate the risk and facilitate the mitigation of the threat from hazardous materials.  
5.2 This guide provides information to help perform the following:  
5.2.1 Select detection equipment;  
5.2.2 Maintain the equipment in a manner that supports its immediate use when required; and  
5.2.3 Store equipment using proper methods and conditions between uses.  
5.2.4 Calibrate equipment in accordance with manufacturer’s recommendations and regulatory requirements:
5.2.4.1 At appropriate intervals;
5.2.4.2 Using appropriate standards; and
5.2.4.3 While maintaining proper documentation of calibration and repair.  
5.2.5 Use and verify equipment performance:
5.2.5.1 As recommended by the manufacturer for its intended application;
5.2.5.2 By performing functional checks; and
5.2.5.3 By knowing any limitations of use.  
5.3 This guide also provides information regarding the types of materials to be included in training programs for the use and maintenance of the equipment.
SCOPE
1.1 This guide provides techniques that can be used to ensure the proper operation and use of Hazardous Material detection equipment. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of this guide may be applicable in all circumstances.  
1.2 This guide is not intended to represent or replace any accreditation or certification documents by which the adequacy of a given professional service must be judged.  
1.3 This guide does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this guide to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.  
1.4 When using HAZMAT equipment follow the manufacturer’s guidance and appropriate safety practices for the expected or suspected threat.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification establishes the ruggedness requirements for equipment used in Hazardous Material (HAZMAT) instrumentation, including devices used to detect or monitor for hazardous material. It defines for design and test purposes the environment in which HAZMAT equipment will likely be exposed during storage, transport, and field use. Passive personal protective equipment such as respirators and protective suits are not covered. The specification addresses materials and manufacture, physical and mechanical properties, performance and environmental requirements, dimensions, mass and permissible variations, workmanship, and finish and appearance. Definitions of terms specific to this standard are provided, including body-worn, hand-carried, mobile, portable, and transportable.
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1.1 This specification describes the ruggedness requirements for equipment used during Hazardous Material (HAZMAT) operations. The conditions defined by this specification include those related to equipment storage, transport, and field use.  
1.2 This specification does not address passive personal protective equipment (PPE) such as respirators and protective suits.  
1.3 The equipment addressed by this specification includes devices used to detect or monitor for hazardous material.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. When using a HAZMAT instrument, follow the manufacturer’s guidance and appropriate safety practices for the threat expected or suspected in the environment where the instrument will be used.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification establishes baseline performance requirements and additional optional capabilities for handheld point chemical vapor detectors (HPCVD) intended for homeland security applications. It provides HPCVD designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities a common set of parameters to match capabilities and user needs. The document specifies chemical detection performance requirements, system requirements, environmental requirements, manuals and documentation, product marking, and packaging.
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1.1 General:  
1.1.1 This document presents baseline performance requirements and additional optional capabilities for handheld point chemical vapor detectors (HPCVD) for homeland security applications. This document is one of several that describe chemical vapor detectors (for example, handheld and stationary) and chemical detection capabilities including: chemical vapor hazard detection, identification, and quantification. An HPCVD is capable of detecting and alarming when exposed to chemical vapors that pose a risk as defined by the Acute Exposure Guideline Levels for Selected Airborne Chemicals (AEGL).  
1.1.2 This document provides the HPCVD baseline requirements, including performance, system, environmental, and documentation requirements. This document provides HPCVD designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities a common set of parameters to match capabilities and user needs.  
1.1.3 This document is not meant to provide for all uses. Manufacturers, purchasers, and end users will need to determine specific requirements including, but not limited to, use by HAZMAT teams, use in explosive atmospheres, use with personal protective equipment (PPE), use by firefighters and law enforcement officers, special electromagnetic compatibility needs, extended storage periods, and extended mission time. These specific requirements may or may not be generally applicable to all HPCVDs.  
1.2 Operational Concepts—HPCVDs are used to detect, identify, classify, or quantify, or combinations thereof, chemical vapor hazards that pose 30-min Acute Exposure Guideline Level-2 (AEGL-2) dangers. The HPCVD should not alarm to environmental background chemical vapors and should provide low false positive alarm rates and no false negatives. Uses of an HPCVD include search and rescue, survey, surveillance, sampling, and temporary fixed-site monitoring. An HPCVD should withstand the rigors associated with uses including, but not limited to, high- and low-temperature use and storage conditions; shock and vibration; radio frequency interference; and rapid changes in operating temperature, pressure, and humidity.  
1.3 HPCVD Chemical Detection Capabilities—Manufacturers document and verify, through testing, the chemical detection capabilities of the HPCVD. Test methods for assessing chemical detection capabilities are available from the Department of Homeland Security and the Department of Defense and are listed in Appendix X3.  
1.4 HPCVD System and Environmental Properties—Manufacturers document and verify, through testing, the system and environmental properties of the HPCVD. Example test methods for assessing the system and environmental properties are listed in Appendix X4.  
1.5 Units—The values stated in SI units are to be regarded as the standard. Vapor concentrations of the hazardous materials are presented in parts per million (ppm) as used in Acute Exposure Guideline Levels for Selected Airborne Chemicals, Vols 1-9 (see 2.1) and in mg/m3.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was ...

ABSTRACT
This specification establishes the baseline performance requirements and additional optional capabilities for stationary point chemical vapor detectors (SPCVD) intended for continuous monitoring of public, non-industrial facilities 24 hours a day, 7 days a week. It provides SPCVD designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities a common set of parameters to match capabilities and user needs. The document specifies chemical detection performance requirements, system requirements, environmental requirements, manuals and documentation, and product marking.
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1.1 General:  
1.1.1 This specification presents baseline performance requirements and additional optional capabilities for stationary point chemical vapor detectors (SPCVD) designed for continuous, 24 h a day 7 days a week, monitoring of public, non-industrial facilities. This specification is one of several that describe chemical vapor detectors (for example, handheld and stationary) and chemical detection capabilities including: chemical vapor hazard detection, identification, classification, and quantification. An SPCVD is capable of detecting and alarming when exposed to chemical vapors that pose a risk as defined by the Acute Exposure Guideline Levels for Selected Airborne Chemicals (AEGL). For example, chemical vapors of interest for homeland security applications, see Appendix X1. The SPCVD should not alarm to background chemical vapors and should provide low false positive alarm rates and no false negatives. Procurement agents and end users must identify the specific chemicals of interest and environmental requirements for the given facility.
1.1.1.1 An SPCVD samples air from immediate surroundings and is comprised of one or more detectors using one or more chemical detection technologies. An SPCVD also includes air sampling system(s), power system(s), computer(s), data storage, data network communication interface(s), and an enclosure, see Fig. 1. An SPCVD may be combined with other SPCVDs, other chemical, biological, radiological, nuclear, and explosive (CBRNE) detectors, and other monitoring devices such as video. A remote command center may monitor and control these devices and communicate information to the responsible authorities and responders, as depicted in Fig. 2.
FIG. 1 An Example Schematic of a Stationary Point Chemical Vapor Detector (SPCVD)
The SPCVD is a unit which samples air from immediate surroundings and is comprised of one or more detectors using one or more chemical detection technologies. An SPCVD also includes air sampling system(s), power system(s), computer(s), data storage, data network communication interface(s), and an enclosure.
FIG. 2 A Conceptual Representation of a Facility Security System with Stationary Point Chemical Vapor Detectors (SPCVDs) integrated with other Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Detectors, and Other Monitoring Devices such as Video  
1.1.2 This specification provides the SPCVD baseline requirements, including performance, system, environmental, and documentation requirements. This specification provides SPCVD designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities a common set of parameters to match capabilities and user needs.  
1.1.3 This specification is not meant to provide for all uses. Manufacturers, purchasers, and end users will need to determine specific requirements based on the installation location and environment.  
1.2 SPCVD Chemical Detection Capabilities—Manufacturers document and verify, through testing, the chemical detection capabilities of the SPCVD. Test methods for assessing chemical detection capabilities are available from the Department of Homeland Security and the Department of Defense and are listed in Appendix X2.  
1.3 SPCVD System and Environmental Properties—Manufacturers document and veri...

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1.1 General:  
1.1.1 This specification provides system designers, manufacturers, integrators, procurement personnel, end-users, practitioners, and responsible authorities a common set of parameters to match the capabilities of chemical detection tools with user needs for their specific application.  
1.1.2 This specification describes required test sample compositions, amounts, and a statistically-based testing approach to be used for evaluating the performance of field fentanyl and fentanyl-related detection equipment and assays as described in Test Method E3290. This specification does not address the estimation of limit of detection.  
1.1.3 This specification is not meant to provide for all uses. Manufacturers, purchasers, and end-users will need to determine specific requirements including, but not limited to, use by hazardous material (HAZMAT) teams; use in explosive or other hazardous environments or atmospheres; use with personal protective equipment (PPE); use by firefighters, law enforcement officers, or FEMA Urban Search & Rescue teams, special electromagnetic compatibility needs, extended storage periods, and extended mission time. These specific requirements may or may not be generally applicable to all chemical detection systems.  
1.2 Operational Concepts—Chemical detection systems are used to detect or identify chemical hazards to support short-term tactical decision-making to protect responders and the public. The system should provide low false-positive and false-negative rates. Uses of these systems include survey, surveillance, and screening of samples, particularly during a response to a suspected fentanyl or fentanyl-related compound. A field-deployable system should withstand the rigors associated with uses including, but not limited to, operation and storage in high and low temperatures, shock and vibration, radio frequency interference, and rapid changes in operating temperature and humidity. Note that this specification does not address testing the potential impact of the rigors associated with use of systems in the field.  
1.2.1 Units—When creating multicomponent test samples for TM 2, TM3, and TM4, all % compositions are stated as weight/volume percent (mg/mL) for both solid and liquids.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This guide includes a wide range of technologies that are currently in use. Considerations and guidance for using these technologies are listed in each technology section.  
5.2 The guide was compiled with significant input, review, and feedback from first responders; assay and instrument manufacturers; and local, state, and federal SMEs.
SCOPE
1.1 This guide provides end-users and practitioners with information on the optimal use and limitations of assays and instrumentation designed to detect fentanyl and fentanyl-related compounds.  
1.2 This guide also provides summaries and links to guidance documents on training, personal protective equipment (PPE), sampling and detection, and medical countermeasures.  
1.3 This guide is intended for first responders and other end-users of field detection assays or instruments used to detect fentanyl and fentanyl-related compounds while out in the field. These instruments could also be used in a laboratory setting.  
1.4 End-users will need to determine specific requirements including, but not limited to, use by hazardous material (HAZMAT) teams, use in explosive or other hazardous environments or atmospheres, use with PPE, use by firefighters or law enforcement officers, special electromagnetic compatibility needs, extended storage periods, and extended mission times. These specific requirements may or may not be generally applicable to all chemical detection systems.  
1.5 Units:  
1.5.1 The metric system is used for all measures of weight. All temperatures are given in °C.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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1.1 General:  
1.1.1 This test method provides a procedure for characterizing the performance of field portable fentanyl detection equipment and assays when utilizing the test samples and statistical considerations described in Specification E3243.  
1.1.2 This test method describes sample preparation and analysis protocols to use when characterizing the performance of various types of field fentanyl detection equipment or assays in a laboratory environment including gas chromatography/mass spectrometry (GC/MS), high pressure mass spectrometry (HPMS), ion mobility spectrometry (IMS), Fourier Transform Infrared (FTIR) spectroscopy, Raman spectroscopy, colorimetric assays, and immunoassays.  
1.1.3 The intent of this test method is to analyze samples in a manner that is analogous to how they are analyzed in the field by Federal and State/Local/Tribal/Territorial (SLTT) law enforcement and first responders, but under much more controlled and reproducible conditions than those that would generally be achievable when conducting field testing.  
1.2 Units:  
1.2.1 When creating test sample mixtures, all concentrations are stated as weight/weight percent (mg/mg) for solid sample mixture test samples, and weight/volume (mg/mL) for solid and liquid test samples that are dissolved in a solvent. When creating diluted liquid test samples (for example, for detection of compounds solubilized in solvent prior to analysis), all concentrations are stated as volume/volume percent (for example, µL/mL).  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 This practice may be used to accomplish several ends: to establish a worldwide frame of reference for terminology, metrics, and procedures for reliably determining trace detection performance of ETDs; as a demonstration by the vendor that the equipment is operating properly to a specified performance score; for a periodic verification by the user of detector performance after purchase; and as a generally-acceptable template adaptable by international agencies to specify performance requirements, analytes and dosing levels, background challenges, and operations.  
5.2 It is expected that current ETD systems will exhibit wide ranges of performance across the diverse explosive types and compounds considered. As in previous versions, this practice establishes the minimum performance that is required for a detector to be considered effective in the detection of trace explosives. An explosives detector is considered to have “minimum acceptable performance” when it has attained a test score of at least 80.
SCOPE
1.1 This practice may be used for measuring, scoring, and improving the overall performance of detectors that alarm on traces of explosives on swabs. These explosive trace detectors (ETDs) may be based on, but are not limited to, chemical detection technologies such as ion mobility spectrometry (IMS) and mass spectrometry (MS).  
1.2 This practice considers instrumental (post-sampling) trace detection performance, involving specific chemical analytes across eight types of explosive formulations in the presence of a standard background challenge material. This practice adapts Test Method E2677 for the evaluation of limit of detection, a combined metric of measurement sensitivity and repeatability, which requires ETDs to have numerical responses.  
1.3 This practice considers the effective detection throughput of an ETD by factoring in the sampling rate, interrogated swab area, and estimated maintenance requirements during a typical eight hour shift.  
1.4 This practice does not require, but places extra value on, the specific identification of targeted compounds and explosive formulations.  
1.5 The functionality of multi-mode instruments (those that may be switched between detection of trace explosives, drugs of interest, chemical warfare agents, and other target compounds) may also be tested. A multi-mode instrument under test shall be set to the mode that optimizes operational conditions for the detection of trace explosives. This practice requires the use of a single set of ETD operational settings for calculating a system test score based on the factors described in 1.2, 1.3, and 1.4. A minimum acceptable score is derived from criteria established in Practice E2520 – 07, and an example of such a test is presented in Appendix X1 (Example 2).  
1.6 Intended Users—ETD developers and manufacturers, testing laboratories, and international agencies responsible for enabling effective deterrents to terrorism.  
1.7 Actual explosives as test samples would be preferable, but standard explosive formulations are not widely available, nor are methods for depositing these quantitatively and realistically on swabs. This practice considers sixteen compounds that are available from commercial suppliers. This does not imply that only these sixteen are important to trace detection. Most ETDs are able to detect many other compounds, but these are either chemically similar (hence redundant) to the ones considered, or are unavailable from commercial suppliers for reasons of stability and safety. Under typical laboratory practices, the sixteen compounds considered are safe to handle in the quantities used.  
1.8 This practice is not intended to replace any current standard procedure employed by agencies to test performance of ETDs for specific applications. Those procedures may be more rigorous, use different compounds or actual explosive formulations, employ different or more realistic background...

SIGNIFICANCE AND USE
5.1 Commercial trace detectors are used by first responders, security screeners, the military, and law enforcement to detect and identify explosive threats and drugs of interest quickly. These trace detectors typically operate by detecting chemical agents in residues and particles sampled from surfaces and can have detection limits for some compounds extending below 1 ng. A trace detector is set to alarm when its response to any target analyte exceeds a programmed threshold level for that analyte. Factory settings of such levels typically balance sensitivity and selectivity assuming standard operating and deployment conditions.  
5.2 The LOD for a substance is commonly accepted as the smallest amount of that substance that can be reliably detected in a given type of medium by a specific measurement process (2). The analytical signal from this amount shall be high enough above ambient background variation to give statistical confidence that the signal is real. Methods for determining nominal LOD values are well known but pitfalls exist in specific applications. Vendors of trace detectors often report detection limits for only a single compound without defining the meaning of terms or reference to the method of determination.
Note 2: There are several different “detection limits” that can be determined for analytical procedures. These include the minimum detectable value, the instrument detection limit, the method detection limit, the limit of recognition, the limit of quantitation, and the minimum consistently detectable amount. Even when the same terminology is used, there can be differences in the LOD according to nuances in the definition used, the assumed response model, and the type of noise contributing to the measurement.  
5.3 When deployed, the individual performance of a trace detector (for example, realistic LODs) is influenced by: (1) manufacturing differences, history, and maintenance; (2) operating configurations (for example, thermal desorption tem...
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1.1 In harmony with the Joint Committee for Guides in Metrology (JCGM) and detection concepts of the International Union of Pure and Applied Chemistry (IUPAC) (1, 2)2, this test method uses a series of replicated measurements of an analyte at dosage levels giving instrumental responses that bracket the critical value, a truncated normal distribution model, and confidence bounds to establish a standard for estimating practical and statistically robust limits of detection.
Note 1: Other standards are available that evaluate the general performance of detection technologies for various analytes in complex matrices (for example, Practice E2520).  
1.2 Here, the limit of detection (LOD90) for a compound is defined to be the lowest mass of that compound deposited on a sampling swab for which there is 90 % confidence that a single measurement in a particular trace detector will have a true detection probability of at least 90 % and a true nondetection probability of at least 90 % when measuring a process blank sample.  
1.3 This particular test method was chosen on the basis of reliability, practicability, and comprehensiveness across tested trace detectors, analytes, and deployment conditions. The calculations involved in this test method are published elsewhere (3), and are performed through an interactive web-based calculator available on the National Institute of Standards and Technology (NIST) site: https://www-s.nist.gov/loda.  
1.4 Intended Users—Trace detector developers and manufacturers, vendors, testing laboratories, and agencies responsible for public safety and enabling effective deterrents to terrorism.  
1.5 While this test method may be applied to any detection technology that produces numerical output, the method is especially applicable to measurement systems influenced by heterogeneous error sources that lead to non-linear and heteroskedastic dose/response relationships and truncated or censored respons...

SIGNIFICANCE AND USE
5.1 The CFT assay provides a sensitive and reliable method to detect ricin biological activity and results can be generated within 3 h. The assay measures the amount of ricin biological activity when compared to a known ricin standard and provides a quantitative measurement for active ricin.  
5.2 The lower limit of quantitation and the upper limit of quantitation for ricin using the CFT assay were measured at 10 ng/mL and 170 ng/mL, respectively (5).  
5.3 This practice is focused on the measurement of reference materials and not environmental samples. Additional control runs may be needed for measurements of environmental samples to ensure that the presence of additional materials in the samples (also referred to as the matrix) will not interfere with the measurements.  
5.4 The CFT assay may be used to determine the presence of active ricin in forensic or bioterrorist samples if the appropriate controls are utilized to ensure valid results (5).  
5.5 The methods described in this document measure the biological activity of ricin and do not detect the presence of inactivated ricin in a given sample.  
5.6 Ricin reference materials have a number of applications, such as testing detection devices, laboratory instruments, environmental sampling methods, disinfection studies, and basic research.
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1.1 This guide is intended for the manufacturers and users of ricin reference material. Ricin reference materials are well-characterized materials that can be used to test detection devices and calibrate laboratory measurements. It is anticipated that ricin reference materials will be characterized by biochemical methods in addition to the measurement of biological activity.  
1.2 This practice details the measurement of ricin biological activity using a cell-free translation (CFT) assay (4).  
1.3 The CFT assay has been developed for use in any biotechnology laboratory where determination or confirmation of ricin biological activity is required.  
1.4 The CFT assay has been validated by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) VP-016 Validation of Cell-Free Translation Assay for the Detection of Ricin Toxin Biological Activities in compliance (5) with Good Laboratory Practices (GLP) Regulations of the Food and Drug Administration (21 CFR Part 58). Strict adherence to the protocol is necessary for validity of the test results.  
1.5 Appendix X1 and Appendix X2 also provide guidance for the measurement of the biological activity of ricin using cell-based assays and the use of synthetic enzyme substrates.  
1.6 Ricin is a category 2 select agent and acquisition of the ricin standard must adhere to the Center for Disease Control and Prevention (CDC) regulations. Ricin is listed on the select agent list (42 CFR Part 72).3 The possession, transfer, and use of ricin are restricted under the Public Health Security Preparedness Act (CRS Report RL31263 Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188): Provision and Changes to Preexisting law). Access to stores of ricin is limited (USA Patriot Act, P.L. 107-56). Ricin is also a prohibited substance under the Biological Weapons Convention and the Chemical Weapons Convention (CRS Report RL31559 Proliferation Control Regimes: Background and Status).  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Ricin is an extremely dangerous toxin. See Section 9 for specific hazards information.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardizat...

SIGNIFICANCE AND USE
5.1 This standard is intended to provide guidance on the deployment of blast resistant trash receptacles that focuses on the mitigation of human injury. It is not in general intended to provide guidance on the protection of structures in the vicinity of where the blast resistant trash receptacles are deployed.  
5.2 The importance of a strategy and procedures for the deployment of blast resistant trash receptacles in crowded places cannot be overly emphasized. Trash receptacles in crowded places have been, and continue to be, an attractive repository for explosives. The selection of deployment locations impacts both the mitigation of the effects of an explosion occurring within one as well as the convenience of using the receptacles.  
5.3 Two major effects resulting from an explosion in a trash receptacle are the production of primary and secondary fragments as well as overpressure from the detonation. The recommendations in this guide are intended to mitigate the damaging effects of fragmentation and overpressure in crowded places.  
5.4 Another effect resulting from an explosion in a trash receptacle is the fireball. This effect may cause burns to people caught within or near to the fireball. Also, it is possible that the heat output from an explosion may cause nearby combustible material to ignite. It is important, therefore, that blast resistant trash receptacles are not placed near combustible materials.  
5.5 The deployment of blast resistant trash receptacles provides a means for decreasing injury and lethality during an explosive event no matter their location when compared to the protection afforded by ordinary trash receptacles or clear plastic bags. Fragments resulting from explosions create the greatest danger to people as fragments may travel several hundred meters and still have velocities that could be lethal or injurious. Blast resistant trash receptacles that meet the requirements of Specification E2740 when subjected to internal explosions equ...
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1.1 This guide identifies the key factors that should be considered prior to the deployment of blast resistant trash receptacles (BRTRs) in crowded places.  
1.1.1 Guidance is included for their deployment at interior and exterior locations associated with the crowded places.  
1.2 Facilities and venues where blast resistant trash receptacles may be deployed include, but are not limited to:  
1.2.1 Airports,  
1.2.2 Banks and other financial institutions,  
1.2.3 Bars and nightclubs,  
1.2.4 Convention centers,  
1.2.5 Entertainment and event centers,  
1.2.6 Hotels,  
1.2.7 Health care locations,  
1.2.8 Museums,  
1.2.9 Places of worship,  
1.2.10 Public government locations including fire and police stations,  
1.2.11 Railway stations, bus stations, and related transit areas,  
1.2.12 Restaurants,  
1.2.13 Retail centers and malls,  
1.2.14 Schools, universities, and related areas used for education,  
1.2.15 Stadiums and arenas, and  
1.2.16 Theaters.  
1.3 Guidance on conducting a threat assessment or vulnerability analysis, and on responding to incidents associated with the deployment of blast resistant trash receptacles is beyond the scope of this document.  
1.4 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardiz...

SIGNIFICANCE AND USE
5.1 This test procedure is used to measure two of the main effects of an explosive detonated in a trash receptacle as related to the type and amount of explosive charge and the location where the charge is placed in the trash receptacle. The two effects are:  
5.1.1 Release of primary and secondary fragments, and  
5.1.2 Physical damage to the trash receptacle.  
5.2 This test procedure is applicable to all trash receptacles, including lidded or non-lidded as supplied by the manufacturer.  
5.3 This test procedure is used to generate data for use in developing performance specifications for trash receptacles.  
5.4 For users having interest in determining overpressures created by the detonation, Appendix X1 provides guidance for making such determinations.
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1.1 This test method provides a procedure for characterizing the performance of a trash receptacle when an explosive is detonated within the receptacle.  
1.1.1 The procedure determines the extent and location of fragments produced during the explosion, and whether breaches are created in the exterior surfaces of the trash receptacle.  
1.1.2 Appendix X1 provides guidance for determining the magnitude of blast waves (that is, external overpressures) developed.  
1.1.3 Effects due to a fireball resulting from the detonation of an explosive within a trash receptacle are beyond the scope of the test method.  
1.2 This test method is intended to be performed in open-air test arenas.  
1.3 The values stated in SI units are to be regarded as the standard. The values stated in parentheses are for information only.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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1.1 This specification provides performance requirements for trash receptacles when subjected to the explosive tests described in Test Method E2639.  
1.1.1 These trash receptacles are intended for use in public spaces.  
1.2 Units—The values stated in SI units are to be regarded as the standard. The values stated in parentheses are for information only.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification prescribes a statistically based testing approach for evaluating the performance of nucleic acid-based detection systems used in bacterial pathogen screening of suspicious visible powders. Nucleic acid-based detection systems are used to detect, identify, or quantify, or combinations thereof, biological hazards to support short-term tactical decision making to protect responders and the public. The system is intended to provide low false-positive and false-negative rates. Uses of these systems include survey, surveillance, and screening of samples, particularly during a response to a suspected biological agent incident.
This specification provides a common set of parameters that system designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities may use to match the capabilities of biological assessment tools with user needs. The testing approach ties performance of the system to a specified lower confidence bound (LCB) on the probability of detection (POD) at a known confidence level (CL). Testing shall be conducted to one of two performance levels: (1) ≥95 % POD with 95% CL, or (2) ≥90 % POD with 90% CL. Four testing modules shall be used to evaluate system performance: biological agent nucleic acid inclusivity testing; biological agent nucleic acid exclusivity testing; suspicious powder testing; and whole organism biological agent spiked suspicious powder testing. The specification also describes three different testing tiers that shall test the full panel of suspicious powders and the whole representative biological agent spiked into powders.
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1.1 General:  
1.1.1 This specification provides system designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities a common set of parameters to match the capabilities of biological assessment tools with user needs.  
1.1.2 This specification is not meant to provide for all uses. Manufacturers, purchasers, and end users will need to determine specific requirements including, but not limited to, use by hazardous material (HAZMAT) teams and Urban Search and Rescue (US&R) teams, use in explosive or other hazardous environments or atmospheres, use with personal protective equipment (PPE), use by firefighters or law enforcement officers or both, special electromagnetic compatibility needs, extended storage periods, and extended mission time. These specific requirements may or may not be generally applicable to all nucleic acid-based detection systems.  
1.2 Operational Concepts—Nucleic acid-based detection systems are used to detect, identify, or quantify, or combinations thereof, biological hazards to support short-term tactical decision making to protect responders and the public. The system should provide low false-positive and false-negative rates. Uses of these systems include survey, surveillance, and screening of samples, particularly during a response to a suspected biological agent incident. A field-deployable system should withstand the rigors associated with uses including, but not limited to, high- and low-temperatures and storage conditions, shock and vibration, radio frequency interference, and rapid changes in operating temperature and humidity. Note that this specification does not address testing the potential impact of the rigors associated with use of systems in the field.  
1.3 Nucleic Acid-Based System Detection Capabilities—Manufacturers or independent third-party testing entities shall document and verify, through testing, the capabilities of the system.  
1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. Liquid concentrations of the biohazard materials are presented in number of biological agents or genome equivalents per volume for pathogens such as bacteria and spores (biological agents/mL, genome equivalents/mL (GE...

SIGNIFICANCE AND USE
4.1 This guide provides guidance on how a surrogate material can be selected and inserted into a field workflow for confidence checks and process assessments of on-site biological assessment technologies to demonstrate that the technology is working in the field environment in the hands of operators.  
4.2 Use of a surrogate material instead of an inactivated or attenuated biological agent (or its components) is beneficial due to (1) ease of production and handling, (2) ease of acquisition and transportation, (3) the ability to use the material with minimal equipment and facility constraints, for example, biosafety containment, and (4) minimized risk of contamination of personnel, equipment and the environment with a potential biological agent.  
4.3 This guide covers the basic design of confidence checks and process assessments that may be used to target (1) the workflow in the field, (2) the performance of the on-site biological assessment technology, and (3) the operator’s ability to process a material in the field workflow, in order to increase confidence in each component. These demonstrations provide emergency responders with insight into routine operation of a nucleic acid-based biological assessment technology and the opportunity to assess and demonstrate their capabilities according to a defined training program in their jurisdiction.  
4.4 This guide may be used to aid operators in the routine use of any nucleic acid-based on-site biological assessment technology. Using a surrogate material, operators are able to gain confidence in their ability to perform operations in the workflow and gather routine information (for example, operator performance, assessment results over time) in the field.  
4.5 This guide should be used in accordance with Practices E2458 and Guide E2770.  
4.6 This guide should be used according to the appropriate risk reduction measures (including personal protective equipment) that are needed for the biosafety level of the surrog...
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1.1 This guide describes factors to consider when developing, selecting, and using a surrogate material for evaluating the operational performance of nucleic acid-based on-site biological assessment technologies. Operational performance includes the workflow, technology, operator, controls, and result reporting.  
1.2 Users of this guide include developers and manufacturers of on-site biological assessment technologies or surrogate materials, as well as the initial responder community and other operators of the technologies.  
1.3 This guide recommends the use of surrogate materials to support training; improve the knowledge, skills, and confidence of operators; and enable confidence check and process assessment demonstrations in support of jurisdictional biothreat mission capabilities as recommended in Guide E2770, Section 8.  
1.4 This guide recommends the use of surrogate materials in combination with a training program as articulated in Guide E2770 and coordinated among the initial responder organization, hazardous materials response unit, Urban Search and Rescue (US&R) team, National Guard Civil Support Team (CST), Laboratory Response Network (LRN) reference laboratory, local law enforcement, the Federal Bureau of Investigation (FBI), and other agencies as defined by jurisdictional protocols.  
1.5 This guide recommends the selection of a surrogate material that challenges the workflow in a way similar to the challenge imposed by suspected biological agents encountered in real-world emergency response scenarios while posing minimal health and safety risks.  
1.6 This guide describes considerations when using a surrogate material for a confidence check of nucleic acid-based on-site biological assessment technologies.  
1.7 This guide describes factors involved in the use of a surrogate material to perform a process assessment when the operator has access to well-characterized nucleic acid-based assays specific ...

SIGNIFICANCE AND USE
5.1 Standard practices for the characterization of spores used as reference materials are important to ensure a uniform basis for testing the performance of detection devices and laboratory instruments. Bacillus spore suspensions can be used for a large variety of purposes including testing environmental sampling techniques, inactivation methods, decontamination methods and basic research.  
5.2 The practice is intended for both manufacturers and end users of Bacillus spore suspensions. The results of the characterization measurements are presented in a report of analysis (ROA). The ROA should provide sufficient detail about the measurement technique to enable the customers to replicate the measurements, allowing them to determine if the properties of the spore suspension changed during shipping and storage.  
5.3 The enumeration of the viable spores and determination of homogeneity by microscopic analysis are two basic measurements required for the minimal characterization of reference materials. Phase contrast microscopy does not require staining to distinguish the “phase bright” dormant spores from phase dark spores, dark vegetative cells and clumps. When spores germinate they appear phase dark under phase contrast imaging (5). Germinated spores in a reference sample will soon die due to lack of nutrients. It is important in storing samples to prevent the premature germination of the spores. This standard practice includes the important steps for these measurements and includes guidance for advanced measurements. Additional guidance is given for advanced techniques to characterize spore suspensions that may be used to provide a higher level of characterized Bacillus  spore reference samples.  
5.4 The specific properties of the spores used for their intended application, such as susceptibility to disinfectant processes, should be determined in addition to the basic measurements covered in this practice. Additional information on the measurement of spore proper...
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1.1 This practice is focused on two basic measurements to characterize Bacillus reference materials, the enumeration of spores using growth of colonies on nutrient media and using phase contrast microscopy to determine spore quality and homogeneity. Additional information on advanced methods for characterization is provided in Appendix X1.  
1.2 This document will provide the user with recommendations for measurement methods, and the details and conditions that should be employed to ensure reliable and high-quality data are obtained. The practice will help ensure that results obtained from the characterization are reported in a uniform manner. This will allow others to replicate the measurements and facilitate the comparison of different lots of Bacillus spore suspensions used as reference materials. It is important to note that the Bacillus species are a heterogeneous group and their specific requirements for growth and sporulation may vary. Users of this practice are encouraged to consult the literature for specific information on the species of Bacillus bacteria they are using (1).2  
1.3 This standard practice does not provide guidance for the identification of unknown species of bacteria. The identification of Bacillus species has been traditionally based on colony morphology, growth on selective media, and biochemical tests, but more recently nucleic acid technologies have enabled the phylogenetic analysis of this group based on 16S DNA sequence similarities (1).  
1.4 Some Bacillus spp. are pathogenic to humans and animals and the user is advised to adhere to safe laboratory procedures and practices for handling spores from these species (2). This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior...

SIGNIFICANCE AND USE
4.1 These practices should be used only to collect visible samples that are suspected biological agents and toxins and have been field screened as defined by the FBI-DHS-HHS/CDC Coordinated Document for explosive hazard, radiological hazard, and other acute chemical hazards.  
4.2 These practices provide standardized methods for collecting, packaging, and transporting suspicious visible powder samples that are suspected biological agents and toxins. Collection of a bulk powder material from a nonporous surface using a sterile swab and laminated card as the collection devices to move the material into a container will depend on several factors, including (but not limited to): (1) amount of visible powder present; (2) sample composition; (3) choice of collection device; (4) size and shape of the collection container; (5) ability of the powder to become aerosolized; (6) texture and porosity of the surface;  (7) humidity; (8) air movement; and (9) electrostatic properties of powders and collection tools/containers.  
4.3 Similarly, these practices standardize methods for sampling suspicious visible powders for on-site analysis, although wipe and swab sampling is often employed in the field for subsequent LRN reference laboratory analysis. The ability to collect suitable samples from nonporous surfaces using a sterile moistened swab will depend on the following factors: (1) swabbing procedure;  (2) swab material; (3) sample composition; and (4) texture of the surface.  
4.4 These practices standardize suspicious powder collection and packaging procedures and swab sampling procedures in order to reduce exposure risk, to reduce variability associated with sample handling and sample analysis, and to increase reliability of sampling visible powder samples from nonporous surfaces.  
4.5 The bulk sample collection practice and the swab sampling practice are recommended for collecting amassed or dispersed powder samples from all nonporous surfaces on which the suspicious po...
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1.1 These practices address collection of visible powders that are suspected biological agents and toxins from solid nonporous surfaces using a bulk collection method, using a dry swab and laminated card, followed by a swab sampling method using a sterile moistened swab. Bulk powder samples are collected and packaged in a manner that permits the maximum amount of the sample to be safely transported to a reference laboratory within the Centers for Disease Control and Prevention (CDC) national Laboratory Response Network (LRN)2 for confirmatory identification and safe storage. If the source of the powder is a letter or small package, that item is also packaged in a manner that permits it to be safely transported to an LRN reference laboratory. A sterile moistened swab may be used to collect residual powder from the nonporous surface and may be used to conduct on-site biological assessments for the purpose of testing for biological agents and toxins.  
1.2 These practices are performed in coordination with the Federal Bureau of Investigation (FBI) as part of a risk assessment including hazard assessment and threat credibility evaluation as recommended and clarified in Guide E2770. The decision to implement these practices and collect a public safety sample will be made by members of the response community of the jurisdiction assuming responsibility through coordination with the FBI and the receiving LRN reference laboratory.  
1.3 Sample Collection Method A covers the bulk collection and packaging of suspicious visible powders that are suspected biological agents and toxins from solid nonporous surfaces. All samples suspected to be biological agents and toxins on nonporous surfaces should be collected according to Sample Collection Method A and sent to an LRN reference laboratory for confirmatory testing.  
1.4 Sample Collection Method B covers swab sampling of residual suspicious powders that are suspected biological ag...

SIGNIFICANCE AND USE
5.1 Community knowledge and experience related to emergency response to threats with a biological agent or toxin at the Federal, State, tribal, and local levels has been translated into a standard guide to assist responder agencies’ progress toward the goal of building operational guidelines for the sample collection and response to a potential biological agent or toxin. The guide is intended to enhance the ability, knowledge, and communication between emergency response team representatives, including fire department, HAZMAT, local law enforcement, Federal Bureau of Investigation, and public health personnel as well as other responders that are responsible for responding to a threat incident involving a biological agent or toxin, or both.  
5.2 This guide supports, and should be utilized as an accompaniment to standard sample collection methods (for example, Practices E2458). Standard guidance insures reduced exposure risk, minimizes on-site sample consumption for preservation of public health samples and forensic samples, reduces variability associated with sample handling, and analysis, and increases the reliability of the sampling procedure when collecting a sample of suspect biological agents and toxins.  
5.3 Development of this standard was at the request and with considerable contributions from the public health and first responder communities in the United States to facilitate collection and evaluation of potential biological agents and toxins in the field.  
5.4 This guide should be incorporated as a reference in Emergency Operation Centers (EOCs), emergency operations plans (EOPs) and Multiagency Coordination Systems (MACS) to assist in policy formation and development of strategic objectives consistent with the needs of the Incident Commander (IC).  
5.5 Documents developed from this standard guide should be referenced and revised as necessary and reviewed on a two-year cycle (at a minimum). The review shall consider new and updated requirements and ...
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1.1 This guide provides considerations for decision-makers when responding to incidents that may involve biological agents and toxins. This guide provides information and guidance for inclusion in response planning, on activities to conduct during an initial response to an incident involving suspected biological agents or toxins, or both.  
1.2 This guide delineates fundamental requirements for developing a sampling and screening capability for biological agents or toxins, or both, within a jurisdiction, practice, or operational area to assure proper involvement, communication, and coordination of all relevant agencies.  
1.3 This guide applies to emergency response agencies that have a role in the initial response to unknown threats that are suspected biological agents and toxins. This guide is designed for but not limited to emergency response services such as law enforcement, fire departments, hazardous materials, public health, and emergency management.  
1.4 This guide assumes implementation begins well before the recognition of an event with a suspected biological agent or toxin, or both, and ends when emergency response actions cease or the response is assumed by federal response teams.  
1.5 This guide utilizes risk-based response architecture and the guidance as described in the National Response Framework and is intended to be coupled with the authority having jurisdiction's (AHJs) understanding of local vulnerabilities and capabilities when developing its plans and guidance documents on response to incidents involving a suspected biological agent or toxin, or both.  
1.6 This guide is compliant with the National Incident Management System (NIMS) and uses Incident Command System (ICS) common terminology. Full compliance with NIMS is recognized as an essential part of emergency response planning. In developing this standard, every effort was made to ensure that all communications between organizational elem...

SIGNIFICANCE AND USE
4.1 This practice specifies an in-vivo measurement of CWA decontamination on the skin.  
4.2 CWA skin decontaminants will have different modes of action including absorption, adsorption, removal, chemical neutralization or some combination of the above. There is, therefore, no single representative in-vitro method for validation of decontamination efficacy of products for skin decontamination. For example, measuring the presence of a radiolabelled chemical warfare agent after chemical neutralization, may give a false positive results. It has been shown that if the agent has been chemically neutralized, the radiolabel may still be present in a non-toxic molecule. In addition, some chemical neutralization methods may break down the original agent, but the breakdown product is highly toxic. In the case of VX, hydrolysis produces a highly toxic product, EA2192 (S-(2-diisopropylaminoethyl) methylphosphonothioic acid (8).  
4.3 This standard practice is of significance in that efficacy is thoroughly evaluated to the extent possible to represent use on human skin. In-vivo studies have demonstrated that simple chemical monitoring for disappearance of the chemical agent may not be sufficient to measure decontamination and neutralization effectiveness. A standard practice is needed for determining actual decontamination and neutralization by measuring the decrease in mortality or lesion size caused by the agent.
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1.1 This practice establishes an in-vivo method for assessing the comparative efficacy of products used for the decontamination of chemical warfare agents (CWAs) on the skin.  
1.2 This practice provides a quantitative efficacy comparison of different skin decontamination products.  
1.3 To minimize the number of animals used, this in-vivo practice should be performed only after rigorous in-vitro studies of the candidate decontaminant, which can show the implied claims including chemical neutralization, decontamination studies on surfaces and appropriate testing such as cytotoxicity.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with the use of decontamination products or CWAs. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 It is essential for response agency personnel to plan, develop, implement, and train on standardized guidelines that encompass policy, strategy, operations, and tactical decisions prior to responding to a radiological incident. Use of this standard practice is recommended for all levels of the response structure.  
5.2 Documents developed from this standard practice should be referenced and revised as necessary and reviewed on a two-year cycle. The review should consider new and updated requirements and guidance, technologies, and other information or equipment that might have a significant impact on the management and outcome of radiological incidents.
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1.1 This practice provides decision-making considerations for response to incidents that involve radioactive materials. It provides information and guidance for what to include in response planning, and what activities to conduct during a response. The scope of this standard practice does not explicitly consider response to INDs or nuclear power plant accidents.3 It does not expressly address emergency response to contamination of food or water supplies.  
1.2 This practice applies to those emergency response agencies that have a role in the response to a radiological incident, excluding an IND incident. It should be used in emergency services response such as law enforcement, fire department, and emergency medical response actions.  
1.3 This practice assumes that implementation begins with the recognition of a radiological incident and ends when emergency response actions cease or the response is assumed by specialized regional, state, or federal response teams.  
1.4 AHJs using this practice will identify hazards, develop a plan, acquire and track equipment, and provide training consistent with the descriptions provided in Section 6. AHJs not able to meet the requirements should refer to the United States (US) Department of Transportation (DOT) Emergency Response Guidebook (ERG) for guidance on how to manage radiological incidents (DOT, current version). This standard practice provides additional guidance and is not intended to replace the ERG, rather to supplement it (see Annex A14).  
1.5 This standard practice does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard practice to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 The practice may be used to accomplish several ends: to establish a worldwide frame of reference for terminology, metrics, and procedures for reliably determining trace detection performance of ETDs; to give developers tangible benchmarks designed to improve detection performance of next-generation ETDs; as a demonstration by the vendor that the equipment is operating properly to a specified performance score; for a periodic verification by the user of detector performance after purchase; and as a generally-acceptable template adaptable by international agencies to specify performance requirements, analytes and dosing levels, background challenges, and operations.  
5.2 It is expected that current ETD systems will exhibit wide ranges of performance across the diverse explosive types and compounds considered. As in previous versions, this practice establishes the minimum performance that is required for a detector to be considered effective in the detection of trace explosives. An explosives detector is considered to have “minimum acceptable performance” when it has attained a test score of at least 80.  
5.3 It is not recommended to use scores exclusively to compare different ETD systems in order to make procurement or deployment decisions. The scores themselves signify ratings based on general detection performance, but do not necessarily reflect capabilities with specific analytes or BCMs, nor do scores consider many factors that users may also consider important: procurement and operating costs, robustness and dependability, training requirements, ease of use, security features, size and weight constraints, network capabilities and interoperability, and radioactive material management.
SCOPE
1.1 This practice may be used for measuring, scoring, and improving the overall performance of detectors that alarm on traces of explosives on swabs. These explosive trace detectors (ETDs) may be based on, but are not limited to, chemical detection technologies such as ion mobility spectrometry (IMS) and mass spectrometry (MS). Technologies that use thermodynamic or optical detection are not specifically addressed, but may be adapted into future versions of this practice.  
1.2 This practice considers instrumental (post-sampling) trace detection performance, involving specific chemical analytes across eight types of explosive formulations in the presence of a standard background challenge material. This practice adapts Test Method E2677 for the evaluation of limit of detection, a combined metric of measurement sensitivity and repeatability, which requires ETDs to have numerical responses.  
1.3 This practice considers the effective detection throughput of an ETD by factoring in the sampling rate, interrogated swab area, and estimated maintenance requirements during a typical eight hour shift.  
1.4 This practice does not require, but places extra value on, the specific identification of targeted compounds and explosive formulations.  
1.5 This practice requires the use of a single set of ETD operational settings for calculating a system test score based on the factors described in 1.2, 1.3, and 1.4. A minimum acceptable score is derived from criteria established in Practice E2520 – 07.  
1.6 Intended Users—ETD developers and manufacturers, testing laboratories, and international agencies responsible for enabling effective deterrents to terrorism.  
1.7 Actual explosives as test samples would be preferable, but standard explosive formulations are not widely available, nor are methods for depositing these quantitatively and realistically on swabs. This practice considers sixteen compounds that are available from commercial suppliers. This does not imply that only these sixteen are important to trace detection. Most ETDs are able to detect many other compounds, but these are either chemically similar (hence redundant) to the ones considered, or are unavailable from commercial suppliers for re...

ABSTRACT
This specification is used to standardize the portable water heaters used on personnel decontamination lines to insure the heaters provide sufficient heated water for as long as they are needed during the emergency. The heater materials of construction shall be easily cleaned of surface mud and grime with no degradation of the unit's ability to perform its function. The performance requirements for portable water heaters are presented in details. The rotometer test method, and ASTM test method shall be performed to meet the requirements prescribed. The water heater unit's water flow shall be measured, and recorded. The water heater unit's cold water inlet and warm water output temperature shall be measured and recorded. The water heater unit's water supply and outlet pressures shall be measured and recorded.
SIGNIFICANCE AND USE
12.1 The use of these acceptance tests will insure that organizations buying portable heaters will be assured the heaters meet certain performance requirements.
SCOPE
1.1 This specification is used to standardize the portable water heaters used on personnel decontamination lines to insure the heaters provide sufficient heated water for as long as they are needed during the emergency.Note 1—These heaters are not intended to be used for the decontamination for any other surface or material. Also, these heaters are intended to be portable and easy to use by first responders during a chemical, biological, radiological, nuclear, and explosive (CBRNE) event.  
1.2 This specification contains a specification section and a test methods section so users need to refer to the section applicable to their needs when using this standard specification.  
1.3 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.Note 2—The U.S. first responder personnel using the equipment manufactured under this standard are not likely to be familiar with SI units so English units need to be included as part of the system documentation and shown on control panels for any equipment sold to U.S. organizations.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This specification is used to standardize the portable air heaters used on personnel decontamination lines to insure the heaters provide sufficient heated air for personnel comfort before, during, and after the decontamination for as long as they are needed during the emergency. The heater materials of construction shall be easily cleaned of surface mud and grime with no degradation of the unit�s ability to perform its function. The preferred fuels for the heater section of the portable air heater are diesel fuel, gasoline, or bottled propane gas. Measurement of the air heater unit�s air flow and input and output temperatures shall be performed.
SIGNIFICANCE AND USE
11.1 The use of these acceptance tests will insure that organizations buying portable heaters will be assured the heaters meet certain performance requirements.
SCOPE
1.1 This specification is used to standardize the portable air heaters used on personnel decontamination lines to insure the heaters provide sufficient heated air for personnel comfort before, during, and after the decontamination for as long as they are needed during the emergency.Note 1—These heaters are not intended to be used for the decontamination for any other surface or material. Also, these heaters are intended to be portable and easy to use by first responders during a chemical, biological, radiological, nuclear, and explosive (CBRNE) event.  
1.2 This specification contains a specification section and a test methods section so users need to refer to the section applicable to their needs when using this standard specification.  
1.3 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.Note 2—The U.S. first responder personnel using the equipment manufactured under this standard are not likely to be familiar with SI units so English units need to be included as part of the system documentation and shown on control panels for any equipment sold to U.S. organizations.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 ETDs are used by first responders, security screeners, the military, and law enforcement to detect and identify explosive threats quickly. ETDs typically operate by detecting chemical agents in residues and particles sampled from surfaces and can have detection limits for some compounds extending below 1 ng. An ETD is set to alarm when its response to any target analyte exceeds a programmed threshold level for that analyte. Factory settings of such levels typically balance sensitivity and selectivity assuming standard operating and deployment conditions.  
5.2 A LOD is commonly accepted as the smallest amount of a particular substance that can be reliably detected in a given type of medium by a specific measurement process (2, 3). The analytical signal from this amount shall be high enough above ambient background variation to give statistical confidence that the signal is real. Methods for determining nominal LOD values are well known (for example, Hubaux and Vos (7) and Practice D6091), but pitfalls exist in specific applications. Vendors of ETDs often report detection limits for only a single compound without defining the meaning of terms or reference to the method of determination.Note 1—There are several different “detection limits” that can be determined for analytical procedures. These include the minimum detectable value, the instrument detection limit, the method detection limit, the limit of recognition, and the limit of quantitation. Even when the same terminology is used, there can be differences in the LOD according to nuances in the definition used, the assumed response model, and the type of noise contributing to the measurement.  
5.3 When deployed, individual ETD performance (for example, realistic LODs) is influenced by: (1) ETD manufacturing differences, history, and maintenance; (2) ETD operating configurations (for example, thermal desorption temperature, analyzer temperature, and type of swab); and (3) environmental conditions (for exampl...
SCOPE
1.1 In harmony with the Joint Committee for Guides in Metrology (JCGM) and detection concepts of the International Union of Pure and Applied Chemistry (IUPAC) (1, 2, 3)2, this test method uses a series of replicated measurements of an analyte at dosage levels giving instrumental responses that bracket the critical value, a truncated normal distribution model, and confidence bounds to establish a standard for determining practical and statistically robust limits of detection to analytes sampled on swabs by explosive trace detectors (ETDs).  
1.2 Here, the limit of detection (LOD90) is defined to be the lowest mass of a particular compound deposited on a sampling swab for which there is 90 % confidence that a single measurement in a particular ETD will have a true detection probability of at least 90 % and a true nondetection probability of at least 90 % when measuring a process blank sample.  
1.3 This particular test method was chosen on the basis of reliability, practicability, and comprehensiveness across tested ETDs, analytes, and deployment conditions. The calculations involved in this test method are published elsewhere (4), and may be performed consistently with an interactive web-based tool available on the National Institute of Standards and Technology (NIST) site: http://pubapps.nist.gov/loda.  
1.4 Intended Users—ETD developers, ETD vendors, ETD buyers, ETD testers, ETD users (first responders, security screeners, and the military), and agencies responsible for public safety and enabling effective deterrents to terrorism.  
1.5 While this test method may be applied to any detection technology that produces numerical output, the procedures have been designed for ion mobility spectrometry (IMS) based ETD systems and tested with low vapor pressure explosive compounds. Compounds are deposited as liquid solutions on swabs and dried before use. As some swabs are absorbent, this deposition procedure may not be opt...

ABSTRACT
This specification establishes the ruggedness requirements for equipment used in Hazardous Material (HAZMAT) instrumentation, including devices used to detect or monitor for hazardous material. It defines for design and test purposes the environment in which HAZMAT equipment will likely be exposed during storage, transport, and field use. Passive personal protective equipment such as respirators and protective suits are not covered. The specification addresses materials and manufacture, physical and mechanical properties, performance and environmental requirements, dimensions, mass and permissible variations, workmanship, and finish and appearance. Definitions of terms specific to this standard are provided, including body-worn, hand-carried, mobile, portable, and transportable.
SCOPE
1.1 This specification describes the ruggedness requirements for equipment used during Hazardous Material (HAZMAT) operations. The conditions defined by this specification include those related to equipment storage, transport, and field use.  
1.2 This specification does not address passive personal protective equipment (PPE) such as respirators and protective suits.  
1.3 The equipment addressed by this specification includes devices used to detect or monitor for hazardous material.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. When using a HAZMAT instrument, follow the manufacturer’s guidance and appropriate safety practices for the threat expected or suspected in the environment where the instrument will be used.

ABSTRACT
This specification establishes the baseline performance requirements and additional optional capabilities for stationary point chemical vapor detectors (SPCVD) intended for continuous monitoring of public, non-industrial facilities 24 hours a day, 7 days a week. It provides SPCVD designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities a common set of parameters to match capabilities and user needs. The document specifies chemical detection performance requirements, system requirements, environmental requirements, manuals and documentation, and product marking.
SCOPE
1.1 General:  
1.1.1 This specification presents baseline performance requirements and additional optional capabilities for stationary point chemical vapor detectors (SPCVD) designed for continuous, 24 hours a day 7 days a week, monitoring of public, non-industrial facilities. This specification is one of several that describe chemical vapor detectors (for example, handheld and stationary) and chemical detection capabilities including: chemical vapor hazard detection, identification, and quantification. An SPCVD is capable of detecting and alarming when exposed to chemical vapors that pose a risk as defined by the Acute Exposure Guideline Levels for Selected Airborne Chemicals (AEGL). For example, chemical vapors of interest for homeland security applications, see Appendix X1. The SPCVD should not alarm to background chemical vapors and should provide low false positive alarm rates and no false negatives. Procurement agents and end users must identify the specific chemicals of interest and environmental requirements for the given facility.
1.1.1.1 An SPCVD samples air from immediate surroundings and is comprised of one or more detectors using one or more chemical detection technologies. An SPCVD also includes air sampling system(s), power system(s), computer(s), data storage, data network communication interface(s), and an enclosure, see Fig. 1FIG. 1 An example schematic of a Stationary Point Chemical Vapor Detector (SPCVD). The SPCVD is a unit which samples air from immediate surroundings and is comprised of one or more detectors using one or more chemical detection technologies. An SPCVD also includes air sampling system(s), power system(s), computer(s), data storage, data network communication interface(s), and an enclosure.. An SPCVD may be combined with other SPCVDs, other chemical, biological, radiological, nuclear, and explosive (CBRNE) detectors, and other monitoring devices such as video. A remote command center may monitor and control these devices and communicate information to the responsible authorities and responders, as depicted in Fig. 2.FIG. 2 A conceptual representation of a facility security system with Stationary Point Chemical Vapor Detectors (SPCVDs) integrated with other chemical, biological, radiological, nuclear, and explosive (CBRNE) detectors, and other monitoring devices such as video.  
1.1.2 This specification provides the SPCVD baseline requirements, including performance, system, environmental, and documentation requirements. This specification provides SPCVD designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities a common set of parameters to match capabilities and user needs.  
1.1.3 This specification is not meant to provide for all uses. Manufacturers, purchasers, and end users will need to determine specific requirements based on the installation location and environment.  
1.2 SPCVD Chemical Detection Capabilities—Manufacturers document and verify, through testing, the chemical detection capabilities of the SPCVD. Test methods for assessing chemical detection capabilities are available from the Department of Homeland Security and the Department of Defense and are listed in Appendix X2.  
1.3 SPCVD System and Environmental Properties—Manufacturers document and verify, through testin...

ABSTRACT
This specification establishes baseline performance requirements and additional optional capabilities for handheld point chemical vapor detectors (HPCVD) intended for homeland security applications. It provides HPCVD designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities a common set of parameters to match capabilities and user needs. The document specifies chemical detection performance requirements, system requirements, environmental requirements, manuals and documentation, product marking, and packaging.
SCOPE
1.1 General:
1.1.1 This document presents baseline performance requirements and additional optional capabilities for handheld point chemical vapor detectors (HPCVD) for homeland security applications. This document is one of several that describe chemical vapor detectors (for example, handheld, and stationary) and chemical detection capabilities including: chemical vapor hazard detection, identification, and quantification. An HPCVD is capable of detecting and alarming when exposed to chemical vapors that pose a risk as defined by the Acute Exposure Guideline Levels for Selected Airborne Chemicals (AEGL).  
1.1.2 This document provides the HPCVD baseline requirements, including performance, system, environmental, and documentation requirements. This document provides HPCVD designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities a common set of parameters to match capabilities and user needs.  
1.1.3 This document is not meant to provide for all uses. Manufacturers, purchasers, and end users will need to determine specific requirements including, but not limited to, use by HAZMAT teams, use in explosive atmospheres, use with personal protective equipment (PPE), use by firefighters and law enforcement officers, special electromagnetic compatibility needs, extended storage periods, and extended mission time. These specific requirements may or may not be generally applicable to all HPCVDs.  
1.2 Operational Concepts—HPCVDs are used to detect, identify, and/or quantify chemical vapor hazards that pose 30-min Acute Exposure Guideline Level-2 (AEGL-2) dangers. The HPCVD should not alarm to environmental background chemical vapors and should provide low false positive alarm rates and no false negatives. Uses of an HPCVD include search and rescue, survey, surveillance, sampling, and temporary fixed-site monitoring. An HPCVD should withstand the rigors associated with uses including, but not limited to, high- and low-temperature use and storage conditions; shock and vibration; radio frequency interference; and rapid changes in operating temperature, pressure, and humidity.  
1.3 HPCVD Chemical Detection Capabilities—Manufacturers document and verify, through testing, the chemical detection capabilities of the HPCVD. Test methods for assessing chemical detection capabilities are available from the Department of Homeland Security and the Department of Defense and are listed in Appendix X3.  
1.4 HPCVD System and Environmental Properties—Manufacturers document and verify, through testing, the system and environmental properties of the HPCVD. Example test methods for assessing the system and environmental properties are listed in Appendix X4.  
1.5 Units—The values stated in SI units are to be regarded as the standard. Vapor concentrations of the hazardous materials are presented in parts per million (ppm) as used in Acute Exposure Guideline Levels for Selected Airborne Chemicals, Vols 1-9 (see 2.1) and in mg/m3.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 This guide provides information that could be used to:  
5.1.1 Establish a hazardous material instrument program;  
5.1.2 Help ensure that consistently reliable instruments are available for the detection of hazardous materials; and  
5.1.3 Provide the safety professional with the means to evaluate the risk and facilitate the mitigation of the threat from hazardous materials.  
5.2 This guide provides information to help perform the following:  
5.2.1 Select detection equipment.  
5.2.2 Maintain the equipment in a manner that supports its immediate use when required.  
5.2.3 Store equipment using proper methods and conditions between uses.  
5.2.4 Calibrate equipment in accordance with manufacturer’s recommendations and regulatory requirements:
5.2.4.1 At appropriate intervals;
5.2.4.2 Using appropriate standards; and
5.2.4.3 While maintaining proper documentation of calibration and repair.  
5.2.5 Use and verify equipment performance:
5.2.5.1 As recommended by the manufacturer for its intended application;
5.2.5.2 By performing functional checks; and  
5.2.5.3 By knowing any limitations of use.  
5.3 This guide also provides information regarding the types of materials to be included in training programs for the use and maintenance of the equipment.
SCOPE
1.1 This guide provides techniques that can be used to ensure the proper operation and use of Hazardous Material detection equipment. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of this guide may be applicable in all circumstances.  
1.2 This guide is not intended to represent or replace any accreditation or certification documents by which the adequacy of a given professional service must be judged.  
1.3 This guide does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this guide to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.  
1.4 When using HAZMAT equipment follow the manufacturer’s guidance and appropriate safety practices for the expected or suspected threat.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
Standard practices for the characterization of spores used as reference materials are important to ensure a uniform basis for testing the performance of detection devices and laboratory instruments. Bacillus spore suspensions can be used for a large variety of purposes including testing environmental sampling techniques, inactivation methods, decontamination methods and basic research.
The practice is intended for both manufacturers and end users of Bacillus spore suspensions. The results of the characterization measurements are presented in a report of analysis (ROA). The ROA should provide sufficient detail about the measurement technique to enable the customers to replicate the measurements, allowing them to determine if the properties of the spore suspension changed during shipping and storage.
The enumeration of the viable spores and determination of homogeneity by microscopic analysis are two basic measurements required for the minimal characterization of reference materials. Phase contrast microscopy does not require staining to distinguish the “phase bright” dormant spores from phase dark spores, dark vegetative cells and clumps. When spores germinate they appear phase dark under phase contrast imaging (5). Germinated spores in a reference sample will soon die due to lack of nutrients. It is important in storing samples to prevent the premature germination of the spores. This standard practice includes the important steps for these measurements and includes guidance for advanced measurements. Additional guidance is given for advanced techniques to characterize spore suspensions that may be used to provide a higher level of characterized Bacillus spore reference samples.
The specific properties of the spores used for their intended application, such as susceptibility to disinfectant processes, should be determined in addition to the basic measurements covered in this practice. Additional information on the measurement of spore properties is located in t...
SCOPE
1.1 This practice is focused on two basic measurements to characterize Bacillus reference materials, the enumeration of spores using growth of colonies on nutrient media and using phase contrast microscopy to determine spore quality and homogeneity. Additional information on advanced methods for characterization is provided in Appendix X1.
1.2 This document will provide the user with recommendations for measurement methods, and the details and conditions that should be employed to ensure reliable and high-quality data are obtained. The practice will help ensure that results obtained from the characterization are reported in a uniform manner. This will allow others to replicate the measurements and facilitate the comparison of different lots of Bacillus spore suspensions used as reference materials. It is important to note that the Bacillus species are a heterogeneous group and their specific requirements for growth and sporulation may vary. Users of this practice are encouraged to consult the literature for specific information on the species of Bacillus bacteria they are using (1).  
1.3 This standard practice does not provide guidance for the identification of unknown species of bacteria. The identification of Bacillus species has been traditionally based on colony morphology, growth on selective media, and biochemical tests, but more recently nucleic acid technologies have enabled the phylogenetic analysis of this group based on 16S DNA sequence similarities (1).
1.4 Some Bacillus spp. are pathogenic to humans and animals and the user is advised to adhere to safe laboratory procedures and practices for handling spores from these species (2).This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to ...

SIGNIFICANCE AND USE
The CFT assay provides a sensitive and reliable method to detect ricin biological activity and results can be generated within 3 h. The assay measures the amount of ricin biological activity when compared to a known ricin standard and provides a quantitative measurement for active ricin.  
The lower limit of quantitation and the upper limit of quantitation for ricin using the CFT assay was measured at 10 ng/mL and 170 ng/mL, respectively (5).  
This practice is focused on the measurement of reference materials and not environmental samples. Additional control runs may be needed for measurements of environmental samples to ensure that the presence of additional materials in the samples (also referred to as the matrix) will interfere with the measurements.  
The CFT assay may be used to determine the presence of active ricin in forensic or bioterrorist samples if the appropriate controls are utilized to ensure valid results (5).  
The methods described in this document measure the biological activity of ricin and do not detect the presence of inactivated ricin in a given sample.  
Ricin reference materials have a number of applications, such as testing detection devices, laboratory instruments, environmental sampling methods, disinfection studies, and basic research.
SCOPE
1.1 This guide is intended for the manufacturers and users of ricin reference material. Ricin reference materials are well-characterized materials that can be used to test detection devices and calibrate laboratory measurements. It is anticipated that ricin reference materials will be characterized by biochemical methods in addition to the measurement of biological activity.
1.2 This practice details the measurement of ricin biological activity using a cell-free translation (CFT) assay (4).
1.3 The CFT assay has been developed for use in any biotechnology laboratory where determination or confirmation of ricin biological activity is required.
1.4 The CFT assay has been validated by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) VP-016 Validation of Cell-Free Translation Assay for the Detection of Ricin Toxin Biological Activities in compliance (5) with Good Laboratory Practices (GLP) Regulations of the Food and Drug Administration (21 CFR Part 58). Strict adherence to the protocol is necessary for validity of the test results.
1.5 Appendix X1 and Appendix X2 also provide guidance for the measurement of the biological activity of ricin using cell-based assays and the use of synthetic enzyme substrates.
1.6 Ricin is a category 2 select agent and acquisition of the ricin standard must adhere to the Center for Disease Control (CDC) regulations. Ricin is listed on the select agent list (42 CFR Part 72). The possession, transfer, and use of ricin are restricted under the Public Health Security Preparedness Act (CRS Report RL31263 Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188): Provision and Changes to Preexisting law). Access to stores of ricin is limited (USA Patriot Act, P.L. 107-56). Ricin is also a prohibited substance under the Biological Weapons Convention and the Chemical Weapons Convention (CRS Report RL31559 Proliferation Control Regimes: Background and Status).  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Ricin is an extremely dangerous toxin. See Section 9 for specific hazards information.

SIGNIFICANCE AND USE
These practices should be used only to collect visible samples that are suspected biothreat agents and have been field screened as defined by the FBI-DHS-HHS/CDC Coordinated Document for explosive hazard, radiological hazard, and other acute chemical hazards.
SCOPE
1.1 These practices address collection of visible powders that are suspected biothreat agents from solid nonporous surfaces using a bulk collection method, using a dry swab and laminated card, followed by a swab sampling method using a sterile moistened swab. Bulk powder samples are collected and packaged in a manner that permits the maximum amount of the sample to be safely transported to a reference laboratory within the Centers for Disease Control and Prevention (CDC) national Laboratory Response Network (LRN) for confirmatory identification and safe storage. If the source of the powder is a letter or small package, that item is also packaged in a manner that permits it to be safely transported to an LRN reference laboratory. A sterile moistened swab may be used to collect residual powder and may be used to conduct on-site biological assessments for the purpose of testing for biothreat agents.
1.2 These practices are performed in coordination with the Federal Bureau of Investigation (FBI) as part of a risk assessment including hazard assessment and threat evaluation as recommended and clarified in Guide . The decision to implement these practices and collect a public safety sample will be made by members of the response community of the jurisdiction assuming responsibility through coordination with the FBI and the receiving LRN reference laboratory.  
1.3 Sample Collection Method A covers the bulk collection and packaging of suspicious visible powders that are suspected biothreat agents from solid nonporous surfaces. All samples suspected to be biothreat agents on nonporous surfaces should be collected according to Sample Collection Method A and sent to a LRN reference laboratory for confirmatory testing.
1.4 Sample Collection Method B covers swab sampling of residual suspicious powders that are suspected biothreat agents from solid nonporous surfaces. Swab samples can be used for on-site biological assessment; however results from on-site biological assessments are not definitive; confirmatory testing by the LRN reference laboratory is necessary to make public health decisions.

SIGNIFICANCE AND USE
The practice may be used to accomplish several ends: to compare detectors before purchase; as a demonstration by the vendor that the equipment is performing properly to a minimal standard; or for a periodic verification of detector performance after purchase.  
This practice establishes the minimum performance that is required for a detector to be considered effective in the detection of trace explosives. An explosives detector is considered to have “minimum acceptable performance” when it has passed all of the evaluation tests without a failure.
This practice uses three explosive compounds—RDX, PETN, and TNT—that are used to represent nitro-based compounds having a range of physical and chemical properties. The concentrations of the solutions of explosive have been determined to be sufficient to provide a positive detector alarm signal. In time, other compounds may be added or substituted into this practice as detection priorities dictate.  
This practice was developed using IMS-based trace explosives detectors, but this practice should also be applicable to any explosives detector designed to analyze trace levels of high-explosive compounds collected on swipes.
This practice does not include procedures to test for compounds that may interfere with detector performance.
This practice does not test the minimum limit of detection or the dynamic range of the trace explosives detector.
This practice does not test for compounds other than high explosives.
This practice only evaluates the response of the detector to traces of pure explosive compounds.
SCOPE
1.1 This practice is primarily intended to assist first responders and security screeners in verifying the minimum acceptable performance of detectors used to identify traces of high explosives such as cyclotrimethylene trinitramine (RDX), pentaerythritol tetranitrate (PETN), and trinitrotoluene (TNT). These explosive detectors may be based on, but are not limited to, ion mobility spectrometry (IMS).
1.2 This practice is used to evaluate the detector response to evaporated residues of low-concentration solutions of explosive compounds placed on test swipes. The solutions used for this evaluation are prepared in a suitable organic solvent and contain a single high explosive.
1.3 This practice does not address or use sampling procedures common to the use of trace explosive detectors. It only tests the response of the detector once a test swipe has been successfully introduced into the explosive detector.
1.4 This practice does not evaluate the effect of contaminants or interferences that may be encountered in sampling for trace explosives in the field.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
Prior to these practices, there have been no validated standard methods by ASTM for collecting, packaging, and transporting suspicious visible powder samples that are suspected biological agents. Successful collection of a bulk powder material from a nonporous surface using a sterile swab and laminated card as the collection devices to move the material into a container will depend on the following factors: (1) amount of visible powder; (2) sample composition; (3) choice of collection device; (4) size and shape of the collection container; (5) ability of the powder to become aerosolized; (6) texture and porosity of the surface; and (7) humidity.
Similarly, prior to these practices, there have been no validated standard methods for sampling suspicious visible powders for on-site analysis, although wipe and swab sampling are often employed in the field. Collecting powder samples from nonporous surfaces using a sterile moistened swab will result in variable success, depending on the following factors: (1) swabbing procedure; (2) swab material; (3) sample composition; and (4) texture of the surface.
These practices standardize suspicious powder collection and packaging procedures and swab sampling procedures in order to reduce exposure risk, to reduce variability associated with sample handling and sample analysis, and to increase reliability of sampling visible powders from nonporous surfaces.
SCOPE
1.1 These practices address collection of visible powders that are suspected biological agents from solid nonporous surfaces using a bulk collection method, using a dry swab and laminated card, followed by a swab sampling method using a sterile moistened swab. Bulk powder samples are collected and packaged in a manner that permits them to be safely transported to an approved laboratory within the Center for Disease Control (CDC) Laboratory Response Network (LRN) for safe storage, confirmatory analysis, and forensic testing. If the source of the powder is a letter or small package, the source is also packaged in a manner that permits it to be safely transported to the laboratory in the CDC Laboratory Response Network. Swab samples taken using a sterile moistened swab are used to collect residual powder and may be used for on-site screening and presumptive testing (biological screening).
1.2 These practices are performed after a risk assessment is conducted and a visible powder is deemed a credible biological threat.
1.3 Sample Collection Method A covers the bulk collection and packaging of suspicious visible powders that are suspected biological agents from solid nonporous surfaces.
1.4 Sample Collection Method B covers swab sampling of residual suspicious powders that are suspected biological agents from solid nonporous surfaces. Swab samples can be used for on-site screening and presumptive testing (biological screening). These presumptive tests are either confirmed or not confirmed by additional testing at the laboratory in the CDC Laboratory Response Network using samples collected in Sample Collection Method A.
1.5 These practices incorporate reference guidance for packaging and transport of suspicious visible powders to comply with all appropriate federal regulations regarding biosafety and biosecurity.
1.6 These practices should only be used to collect visible samples that are suspected biological hazards and have been screened according to reference guidance for explosive hazard, radiological hazard, and other acute chemical hazards.
1.7 The bulk sample collection practice and the swab sampling practice are recommended for collecting amassed or dispersed powder samples from all nonporous surfaces on which the suspicious powder sample is clearly visible.
1.8 These practices are not recommended for samples on porous materials such as upholstery, carpeting, air filters, or ceiling tiles.
1.9 These practices are recommended for collecting visible powders where the bulk of the powder s...