ASTM E2770-2017 Standard Guide for Operational Guidelines for Initial Response to Suspected Biological Agents and Toxins《可疑生物制剂和毒素初始反应操作指引的标准指南》.pdf

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1、Designation: E2770 10E2770 17Standard Guide forOperational Guidelines for Initial Response to a SuspectedBiothreat AgentSuspected Biological Agents and Toxins1This standard is issued under the fixed designation E2770; the number immediately following the designation indicates the year oforiginal ado

2、ption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONAbiothreat threat with a biological agent or toxin is a serious matter

3、that affects public health, publicsafety, the economy and the general confidence of the people. The National Strategy for HomelandSecurity and its National Response Framework focuses homeland security efforts on preventing anddisrupting terrorist attacks, protecting the American people, our critical

4、 infrastructure and keyresources, and responding to and recovering from incidents that do occur while continuing tostrengthen the foundation of our nation. As laid out by the National Response Framework, acoordinated and synchronous response to suspected acts of bio-terrorism requires advance planni

5、ng,including the equipping and training of emergency responders prior to an incident. The goal of thisstandard guide is to support national standards for responding to and collecting suspected biothreat-biological agents and toxins with guidance centered on coordination among representatives ofemerg

6、ency response teams, including hazardous materials response teams, law enforcement, publichealth, including the Centers for Disease Control and Prevention (CDC) national Laboratory ResponseNetwork (LRN), and the Federal Bureau of Investigation (FBI). This standard guide provides uniformguidance that

7、 covers all of the following components: response planning, responder training,competency evaluation, proficiency testing, concept of operations, hazard assessment, threatevaluation, sample collection, field screening, risk communication and documentation for respondingto visible powders suspected o

8、f being biothreat agents. an incident suspected of a biological agent ortoxin, or both.1. Scope1.1 This guide provides considerations for decision-makers when responding to incidents that may involve biothreats. biologicalagents and toxins. This guide provides information and guidance for inclusion

9、in response planning, on activities to conduct duringan initial response to an incident involving suspected biothreat agents. biological agents or toxins, or both.1.2 This guide delineates fundamental requirements for developing a biothreat sampling and screening capability for biologicalagents or t

10、oxins, or both, within a jurisdiction, practice, or operational area to assure proper involvement, communication, andcoordination of all relevant agencies.1.3 This guide applies to emergency response agencies that have a role in the initial response to a biothreat incident. unknownthreats that are s

11、uspected biological agents and toxins. This guide is designed for but not limited to emergency response servicessuch as law enforcement, fire departments, hazardous materials, public health, and emergency management.1.4 This guide assumes implementation begins well before the recognition of a suspec

12、ted biothreat event an event with asuspected biological agent or toxin, or both, and ends when emergency response actions cease or the response is assumed by federalresponse teams.1.5 This guide utilizes risk-based response architecture and the guidance as described in the National Response Framewor

13、k andis intended to be coupled with the authority having jurisdictions (AHJs) understanding of local vulnerabilities and capabilitieswhen developing its plans and guidance documents on response to incidents involving a suspected biothreat.biological agent ortoxin, or both.1 This practiceguide is und

14、er the jurisdiction of ASTM Committee E54 on Homeland Security Applications and is the direct responsibility of Subcommittee E54.01 onCBRNE Sensors and Detectors.Current edition approved Oct. 15, 2010April 1, 2017. Published November 2010May 2017. Originally approved in 2010. Last previous edition a

15、pproved in 2010 asE2770 10. DOI: 10.1520/E2770-10.10.1520/E2770-17.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict a

16、ll changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2

17、959. United States11.6 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. Indeveloping this standard, every effort was made

18、to ensure that all communications between organizational elements during anincident are presented in plain language according to NIMS 2008. In keeping with this NIMS requirement, key definitions andterms, using plain English, are incorporated.1.7 This guide does not purport to address all of the saf

19、ety concerns, if any, associated with its use. It is the responsibility ofthe user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.1.8 This international standard was developed in accordance with internationa

20、lly recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E2458 Practice

21、s for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being BiothreatAgents from Nonporous SurfacesE2601 Practice for Radiological Emergency ResponseF2412 Test Methods for Foot ProtectionF2413 Specification for Performance Requirements for Protective (Safety) Toe Ca

22、p Footwear2.2 Federal Government Regulations:318 USC 175178 Prohibitions with respect to biological weaponsDefinitions18 USC 1038 False Information and HoaxesDOT - 49 CFR, Parts 171-180 Hazardous Materials RegulationsDOT - 49 CFR 172, Subpart H Transportation TrainingDOT - 49 CFR 173 General Require

23、ments for Shipments and PackagingDOT - 49 CFR 178 Specifications for PackagingEPA - 40 CFR 300 National Oil and Hazardous Substances Pollution Contingency Plan (NCP)EPA - 40 CFR 311 Worker ProtectionNRC - 10 CFR 20 Standards for Protection against RadiationNIOSH - 42 CFR 84 Respiratory Protective De

24、vicesOSHA - 29 CFR 1910 Subpart Z and 29 CFR 1926 Subpart Z Toxic and Hazardous SubstancesOSHA - 29 1910.1096 and 29 CFR 1926.53 Ionizing RadiationOSHA - 29 CFR 1910.120 Hazardous Waste Operations and Emergency Response (HAZWOPER) standardOSHA - 29 CFR 1910 Subpart I (Sections 132 to 139) Personal P

25、rotective EquipmentOSHA - 29 CFR 1910.1200 Hazard Communication2.3 Federal Guidance:FBI-DHS-HHS/CDC Coordinated Document, Guidance on Initial Response to a Suspicious Letter/Container with a PotentialBiological threat, November 2, 2004.NIMS 2008 National Incident Management System4Planning Guidance

26、for Recovery Following Biological Incidents, Biological Decontamination Standards Working Group,Subcommittee on Decontamination Standards and Technology Committee on Homeland and National Security, NationalScience and Technology Council, May 20094NRF 2008 National Response Framework4OSHA - CPL 02-02

27、-073 Inspection Procedures for 29 CFR 1910.120 and 1926.65, Paragraph (q): Emergency Response toHazardous Substance ReleasesEPA - Safety, Health, and Environmental Management (SHEM) Guide No. 44 Personal Protective Equipment, October 2004EPA - Safety, Health, and Environmental Management (SHEM) Guid

28、eline No. 46 Respiratory Protection, dated October 2004EPA - Order 1460.1 Occupational Medical Surveillance Program, June 18, 1996EPA/600/R-08/105 EPAAll Hazards Receipt Facility Screening Protocol EPAAll Hazards Receipt Facility Screening Protocol,(EPA/600/R-08/105) September 200852 For referencedA

29、STM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from U.S. Government Printing Office Superintendent of Documents,

30、732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.4 Available from Federal Emergency Management Agency (FEMA), 500 C St., SW, Washington, DC 20472, http:/www.fema.gov.5 Available from http:/HAZMAT.dot.gov/pubs/erg/gydebook.htm.Environmental Protection Agency (EPA

31、), 1200 Pennsylvania Ave, NW, Washington, DC 20460,http:/nepis.epa.gov.E2770 172NIOSH Publication No. 2009-132 Recommendations for the Selection and Use of Respirators and Protective Clothing forProtection Against Biological AgentsFBI Laboratory Publication: Handbook of Forensic Services 20032013DOT

32、, current version, Emergency Response Guidebook (ERG)6CDC/NIOSH Surface Sampling Procedures for Bacillus anthracis Spores from Smooth, Non-porous Surfaces, April 26, 20127DHS Framework for a Biothreat Field Response Mission Capability, April 201182.4 NFPA Standards:9NFPA 472 Standard for Competence

33、of Responders to Hazardous Materials/Weapons of Mass Destruction Incidents, 2008EditionNFPA 1994 Standard on Protective Ensembles for Chemical/Biological Terrorism IncidentsNFPA 1600 Standard on Disaster/Emergency Management and Business Continuity Programs, 2007Continuity/Continuity ofOperations Pr

34、ograms, 2016 Edition2.5 IATA Standards:10IATA PI 602 Infectious Diseases (Infectious Substances)IATA PI 650 Shipping of Diagnostic SamplesIATA DGR 46th Edition 2005IATA DGR Addendum I January 2005IATA DGR Addendum II March 2005IATA DGR Addendum III July 20052.6 ANSI Standards:ANSI Z41-1999 American

35、National Standard for Personal Protection - Protective FootwearANSI Z87.1-2003 American National Standard for Occupational and Educational Personal Eye and Face Protection DevicesANSI Z88.2-1992 American National Standard Practices for Respiratory ProtectionANSI Z88.10-2001 American National Standar

36、d for Personal Protection - Respirator Fit Testing MethodsANSI/ISEA Z89.1-2003 American National Standard for Personal Protection - Protective Headwear for Industrial WorkersRequirementsANSI/Compressed Gas Association, CGA G-7.1-1997 Commodity Specification for Air2.7 International Standards and Gui

37、dance:IAFC InternationalAssociation of Fire Chiefs (IAFC) Guidance, Model Procedures for Responding to a Package with Suspicionof a Biological Threat, October 2008ISO/IEC Guide 43Standard 17043 ISO/IEC Standard 17043 Conformity assessmentGeneral requirements for proficiencytesting3. Terminology3.1 D

38、efinitions:3.1.1 aseptic technique, noperation or performance of a procedure or method under carefully controlled conditions to reducethe risk of exposure and prevent the introduction of unwanted material/matter (contamination) into a sample.3.1.2 authority having jurisdiction (AHJ), nthe organizati

39、on, office, or individual responsible for enforcing the requirementsof a code or standard, or approving equipment, materials, an installation, or a procedure. NFPA3.1.3 biothreatbiological agent, nany microorganism, virus, infectious substance, or biological product that may beengineered as a result

40、 of biotechnology, or any naturally occurring or bioengineeredmicroorganism (including but not limited to,bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or any naturally occurring, bioengineered or synthesizedcomponent of any such microorganism, virus,microorganism or

41、infectious substance, or biological product, capable of causing: (1)death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; (2) deterioration of food,water, equipment, supplies, or material of any kind; or (3) or, deleterious alteration of the envi

42、ronment. 18 USC 1751783.1.4 bulk powder, na visible powder, at least approximately 1 tsp or 5 mlmL in volume amassed or dispersed over a limitedarea (optimally, area should be less than 20 by 20 cm (approximately 8 by 8 in.).3.1.5 chain of custody, nset of procedures and documents to account for the

43、 integrity of a sample by tracking its handling andstorage from point of sample collection to final disposition of the sample.3.1.6 cold zone, nthe uncontaminated area where workers are unlikely to be exposed to hazardous substances or dangerousconditions; also known as Clean Zone or Support Zone. C

44、PL 02-02-071 Directive6 Available from http:/HAZMAT.dot.gov/pubs/erg/gydebook.htm.7 Available from http:/www.cdc.gov/niosh/topics/emres/surface-sampling-bacillus-anthracis.html.8 Available from http:/www.hsdl.org/?view a dangeror peril. NIMS3.1.15 HAZMAT responder, na trained and certified individua

45、l who is a member of a hazardous material response team orqualified to respond to incidents involving toxic industrial chemicals, chemical warfare agents and other weapons of massdestruction, or both. A HAZMAT response specialist will have additional training to respond to that may include response

46、tospecific weapons of mass destruction.3.1.16 hot zone, nthe area, located on the site where contamination is either known or expected and where potential forgreatest exposure exists; also known as Exclusion Zone or ExZ. CPL 02-02-071 Directive3.1.17 incident commander (IC), nthe individual responsi

47、ble for all incident activities, including the development of strategiesand tactics and the ordering and release of resources. The IC has overall authority and responsibility for conducting incidentoperations and is responsible for the management of all incident operations at the incident site. NIMS

48、3.1.18 jurisdiction, na range or sphere of authority. Public agencies have jurisdiction at an incident within their area ofresponsibility. Jurisdictional authority at an incident can be political, geographic (for example, city, county, tribal, State, or Federalboundary lines) or functional (for exam

49、ple, law enforcement, public health). NIMS3.1.19 multiagency coordination system (MACS), na system that provides the architecture to support coordination for incidentprioritization, critical resource allocation, communications systems integration, and information coordination. MACS assistagencies and organizations responding to an incident. The elements of a MACS include facilities, equipment, personnel,procedures, and communications. Two of the most commonly used elements are Emergency Operations Centers and MAC Groups.NIMS3.1.20 on-site biological assessme