ASTM E2458-2010 Standard Practices for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biological Agents from Nonporous Surfaces《疑为无空隙表面产生的生.pdf

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1、Designation: E2458 10Standard Practices forBulk Sample Collection and Swab Sample Collection ofVisible Powders Suspected of Being Biothreat Agents fromNonporous Surfaces1This standard is issued under the fixed designation E2458; the number immediately following the designation indicates the year ofo

2、riginal adoption 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.1. Scope1.1 These practices address collection of visible powdersthat ar

3、e suspected biothreat agents from solid nonporoussurfaces using a bulk collection method, using a dry swab andlaminated card, followed by a swab sampling method using asterile moistened swab. Bulk powder samples are collected andpackaged in a manner that permits the maximum amount of thesample to be

4、 safely transported to a reference laboratory withinthe Centers for Disease Control and Prevention (CDC) nationalLaboratory Response Network (LRN)2for confirmatory iden-tification and safe storage. If the source of the powder is a letteror small package, that item is also packaged in a manner thatpe

5、rmits it to be safely transported to an LRN referencelaboratory. A sterile moistened swab may be used to collectresidual powder and may be used to conduct on-site biologicalassessments for the purpose of testing for biothreat agents.1.2 These practices are performed in coordination with theFederal B

6、ureau of Investigation (FBI) as part of a riskassessment including hazard assessment and threat evaluationas recommended and clarified in Guide E2770. The decision toimplement these practices and collect a public safety samplewill be made by members of the response community of thejurisdiction assum

7、ing responsibility through coordination withthe FBI and the receiving LRN reference laboratory.1.3 Sample Collection Method A covers the bulk collectionand packaging of suspicious visible powders that are suspectedbiothreat agents from solid nonporous surfaces. All samplessuspected to be biothreat a

8、gents on nonporous surfaces shouldbe collected according to Sample Collection MethodAand sentto a LRN reference laboratory for confirmatory testing.1.4 Sample Collection Method B covers swab sampling ofresidual suspicious powders that are suspected biothreat agentsfrom solid nonporous surfaces. Swab

9、 samples can be used foron-site biological assessment; however results from on-sitebiological assessments are not definitive; confirmatory testingby the LRN reference laboratory is necessary to make publichealth decisions.1.5 These practices incorporate reference guidance forpackaging and transport

10、of suspicious visible powders tocomply with all appropriate federal regulations regardingbiosafety and biosecurity.1.6 These practices should only be used to collect visiblesamples that are suspected biothreat agents and have been fieldscreened according to reference guidance for explosive hazard,ra

11、diological hazard, and other acute chemical hazards.1.7 The values stated in SI units are to be regarded asstandard. The values given in parentheses are for informationonly.1.8 This standard does not purport to address all of thesafety concerns associated with its use. It is the responsibilityof the

12、 user of this standard to establish appropriate safety andhealth practices and determine the applicability of regulatorylimitations prior to use.2. Referenced Documents2.1 ASTM Standards:3E2770 Guide for Operational Guidelines for Initial Re-sponse to a Suspected Biothreat AgentF2412 Test Methods fo

13、r Foot ProtectionF2413 Specification for Performance Requirements forFoot Protection2.2 Federal Government Regulations:418 USC 175 Prohibitions with respect to biological weap-onsDOT 49 CFR, Parts 171-180 Hazardous Materials Regula-tions1These practices are under the jurisdiction of ASTM Committee E

14、54 onHomeland Security Applications and are the direct responsibility of SubcommitteeE54.01 on CBRNE Sensors and Detectors.Current edition approved Oct. 1, 2010. Published November 2010. Originallyapproved in 2006. Last previous edition approved in 2006 as E2458 06. DOI:10.1520/E2458-10.2The CDC Lab

15、oratory Response Network is the network responsible forhandling clinical specimens and environmental samples containing suspectedbiothreat agents.3For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards

16、 volume information, refer to the standards Document Summary page onthe ASTM website.4Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, and also availableonline from Occupational Safety and Health Administration (

17、www.osha.gov).1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.DOT - 49 CFR 172 Subpart H, Transportation TrainingDOT - 49 CFR 173 General Requirements for Shipmentsand PackagingsDOT - 49 CFR 178 Specifications for PackagingsEPA - 40

18、CFR 300 National Oil and Hazardous SubstancesPollution Contingency Plan (NCP)EPA - 40 CFR 311 Worker ProtectionNRC - 10 CFR 20 Standards for Protection against Radia-tionNIOSH - 42 CFR 84 Respiratory Protective DevicesOSHA - 29 CFR 1910 Subpart Z and 29 CFR 1926 SubpartZ Toxic and Hazardous Substanc

19、esOSHA - 29 1910.1096 and 29 CFR 1926.53 IonizingRadiationOSHA- 29 CFR 1910.120 Hazardous Waste Operations andEmergency Response (HAZWOPER) standardOSHA - 29 CFR 1910 Subpart I (Sections 132 to 139) Per-sonal Protective EquipmentOSHA - 29 CFR 1910.1200 Hazard Communication2.3 Federal Guidance:OSHA -

20、 CPL 02-02-073 Inspection Procedures for 29 CFR1910.120 and 1926.65, Paragraph (q): Emergency Re-sponse to Hazardous Substance ReleasesNIOSH Publication No. 2009-132 Recommendations forthe Selection and Use of Respirators and ProtectiveClothing for Protection Against Biological AgentsFBI Laboratory

21、Publication Handbook of Forensic Services2003FBI-DHS-HHS/CDC Coordinated Document Guidance onInitial Response to a Suspicious Letter/Container with aPotential Biological threat, November 2, 20042.4 NFPA Standards:5NFPA 472 Standard for Competence of Responders toHazardous Materials/Weapons of Mass D

22、estruction Inci-dents, 2008 EditionNFPA 1994 Standard on Protective Ensembles forChemical/Biological Terrorism Incidents2.5 IATA Standards:6IATA PI 602 Infectious Diseases (Infectious Substances)IATA PI 650 Shipping of Diagnostic SamplesIATA DGR 46th Edition, 2005IATA DGR Addendum I, January 2005IAT

23、A DGR Addendum II, March 2005IATA DGR Addendum III, July 20052.6 ANSI Standards:7ANSI Z41-1999 American National Standard for PersonalProtection - Protective FootwearANSI Z87.1-2003 American National Standard for Occupa-tional and Educational Personal Eye and Face ProtectionDevicesANSI Z88.2-1992 Am

24、erican National Standard Practicesfor Respiratory ProtectionANSI Z88.10-2001 American National Standard for Per-sonal Protection - Respirator Fit Testing MethodsANSI/ISEA Z89.1-2003 American National Standard forPersonal Protection - Protective Headwear for IndustrialWorkers RequirementsANSI/Compres

25、sed Gas Association, CGA G-7.1-1997 Commodity Specification for Air2.7 IAFC Guidance:8Model Procedures for Responding to a Package withSuspicion of a Biological Threat, October 20083. Terminology3.1 Definitions:3.1.1 aseptic technique, noperation or performance of aprocedure or method under carefull

26、y controlled conditions toreduce the risk of exposure and prevent the introduction ofunwanted material/matter (contamination) into a sample.3.1.2 biothreat agent, nany microorganism, virus, infec-tious substance, or biological product that may be engineeredas a result of biotechnology, or any natura

27、lly occurring orbioengineered component of any such microorganism, virus,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) deteriorationof food, water, equipment, supplies,

28、 or material of any kind; or(3) deleterious alteration of the environment. 18 USC 1753.1.3 bulk powder, na visible powder, at least approxi-mately 1 teaspoon or 5 ml in volume amassed or dispersed overa limited area (optimally, area should be less than 20 by 20 cm(approximately 8 by 8 in.).3.1.4 cha

29、in of custody, nset of procedures and documentsto account for the integrity of sample by tracking its handlingand storage from point of sample collection to final dispositionof the sample.3.1.5 cold zone, nthe uncontaminated area where workersare unlikely to be exposed to hazardous substances or dan

30、ger-ous conditions; also known as Clean Zone or Support Zone.CPL 02-02-071 Directive3.1.6 confirmatory analysis, na test or a series of assaysthat definitively identifies the presence of a suspected sub-stance or agent.3.1.6.1 DiscussionConfirmatory analysis of a biothreatfor public health action ca

31、n be performed only by an LRNnational or reference laboratory.3.1.7 decontamination, nthe physical or chemical pro-cess, or both, of reducing and preventing the spread ofcontaminants from people, animals, the environment, or equip-ment involved at hazardous materials/weapons of mass de-struction (WM

32、D) incidents. NFPA3.1.8 field screening, nfield measurements utilized earlyin the site assessment process to define and delineate thecontaminants present, support tactical decision making andaddress operational safety measures.3.1.8.1 DiscussionField screening does not include mea-surements of biolo

33、gical properties which is termed on-sitebiological assessments (see 3.1.12).5Available from National Fire Protection Association (NFPA), 1 BatterymarchPark, Quincy, MA 02269-9101.6Available from the International Air Transport Association, 800 Place Victoria,PO Box 113, Montreal-H4Z 1M1, Quebec, Can

34、ada.7Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.8Available from International Association of Fire Chiefs (IAFC), 4025 FairRidge Drive, Suite 300 Fairfax, VA 22033, http:/www.iafc.org.E2458 1023.1.9 hazard, nsomething

35、that is potentially dangerous orharmful, often the root cause of an unwanted outcome; adanger or peril. NIMS3.1.10 hot zone, nthe area, located on the site wherecontamination is either known or expected and where potentialfor greatest exposure exists; also known as Exclusion Zone orExZ. CPL 02-02-07

36、1 Directive3.1.11 incident commander (IC), nthe individual respon-sible for all incident activities, including the development ofstrategies and tactics and the ordering and release of resources.3.1.11.1 DiscussionThe IC has overall authority and re-sponsibility for conducting incident operations and

37、 is respon-sible for the management of all incident operations at theincident site. NIMS3.1.12 on-site biological assessment, nmeasurements ofproperties inherent to biological materials performed in thefield using rapid, field-based procedures and assays.3.1.13 personal protective equipment (PPE), n

38、equipmentprovided to shield or isolate a person from the chemical,biological, physical, and thermal hazards that can be encoun-tered at hazardous materials/weapons of mass destruction(WMD) incidents. NFPA3.1.14 presumptive test, nnon-definitive test used toevaluate a material for the presence of a s

39、ubstance or agent, orthe presence of signatures of a substance or agent.3.1.15 risk, nthe probability of suffering a loss or harm orinjury; peril.3.1.16 threat, nan indication of possible violence, harm,or danger and may include an indication of intent and capa-bility. NIMS3.1.17 warm zone, nthe tra

40、nsition area between the Ex-clusion Zone (ExZ or hot zone) and the Support Zone (SZ orcold zone) used to reduce and limit the amount of contamina-tion on people and equipment, and in the air, water, and soilthat may be transferred into nonhazardous areas; the CRZcontains decontamination facilities,

41、and functions as a bufferzone surrounding the ExZ; also known as the contaminationreduction zone or CRZ. CPL 02-02-071 Directive3.1.18 weapon of mass destruction (WMD), nany weaponor device that is intended, or has the capability, to cause deathor serious bodily injury to a significant number of peo

42、plethrough the release, dissemination, or impact of (1) toxic orpoisonous chemicals or their precursors; (2) a disease organ-ism; or (3) radiation or radioactivity. U.S. Code Title 50,Ch. 40, Sect. 2302, War and National Defense Definitions3.2 Acronyms:3.2.1 AHJAuthority Having Jurisdiction3.2.2 ANS

43、IAmerican National Standards Institute3.2.3 ASTMAmerican Society for Testing and Materials3.2.4 CDCCenters for Disease Control and Prevention3.2.5 CFRCode of Federal Regulations3.2.6 CRZContamination Reduction Zone3.2.7 CSTCivil Support Team3.2.8 DHSDepartment of Homeland Security3.2.9 DOTDepartment

44、 of Transportation3.2.10 EOCEmergency Operations Center3.2.11 EPAEnvironmental Protection Agency3.2.12 ExZExclusion Zone3.2.13 FBIFederal Bureau of Investigation3.2.14 FEMAFederal Emergency Management Agency3.2.15 HAZMATHazardous Materials3.2.16 HHSHealth and Human Services3.2.17 IAFCInternational A

45、ssociation of Fire Chiefs3.2.18 IATAInternational Air Transport Association3.2.19 ICIncident Commander3.2.20 ICSIncident Command System3.2.21 IECInternational Electrotechnical Commission3.2.22 ISEAInternational Safety Equipment Association3.2.23 ISOInternational Organization for Standardization3.2.2

46、4 LRNLaboratory Response Network3.2.25 MACSMultiagency Coordination System3.2.26 NFPANational Fire Protection Association3.2.27 NIMSNational Incident Management System3.2.28 NIOSHNational Institute for Occupational Safetyand Health3.2.29 NRCNuclear Regulatory Commission3.2.30 OSHAOccupational Safety

47、 and HealthAdministra-tion3.2.31 PBSPhosphate Buffered Saline3.2.32 PPEPersonal Protective Equipment3.2.33 SZSupport Zone3.2.34 USARUrban Search and Rescue3.2.35 WMDWeapons of Mass Destruction4. Significance and Use4.1 These practices should be used only to collect visiblesamples that are suspected

48、biothreat agents and have been fieldscreened as defined by the FBI-DHS-HHS/CDC CoordinatedDocument for explosive hazard, radiological hazard, and otheracute chemical hazards.4.2 These practices provide standardized methods for col-lecting, packaging, and transporting suspicious visible powdersamples

49、 that are suspected biothreat agents. Collection of abulk powder material from a nonporous surface using a sterileswab and laminated card as the collection devices to move thematerial into a container will depend on several factors,including (but not limited to): (1) amount of visible powderpresent; (2) sample composition; (3) choice of collectiondevice; (4) size and shape of the collection container; (5)ability of the powder to become aerosolized; (6) texture andporosity of the surface; (7) humidity; (8) air movement; and (9