1、Designation: E2458 17Standard Practices forBulk Sample Collection and Swab Sample Collection ofVisible Powders Suspected of Being Biological Agents andToxins from Nonporous Surfaces1This standard is issued under the fixed designation E2458; the number immediately following the designation indicates
2、the year oforiginal 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 po
3、wdersthat are suspected biological agents and toxins from solidnonporous surfaces using a bulk collection method, using a dryswab and laminated card, followed by a swab sampling methodusing a sterile moistened swab. Bulk powder samples arecollected and packaged in a manner that permits the maximumam
4、ount of the sample to be safely transported to a referencelaboratory within the Centers for Disease Control and Preven-tion (CDC) national Laboratory Response Network (LRN)2forconfirmatory identification and safe storage. If the source of thepowder is a letter or small package, that item is also pac
5、kagedin a manner that permits it to be safely transported to an LRNreference laboratory. A sterile moistened swab may be used tocollect residual powder from the nonporous surface and may beused to conduct on-site biological assessments for the purposeof testing for biological agents and toxins.1.2 T
6、hese practices are performed in coordination with theFederal Bureau of Investigation (FBI) as part of a riskassessment including hazard assessment and threat credibilityevaluation as recommended and clarified in Guide E2770. Thedecision to implement these practices and collect a publicsafety sample
7、will be made by members of the responsecommunity of the jurisdiction assuming responsibility throughcoordination with the FBI and the receiving LRN referencelaboratory.1.3 Sample Collection Method A covers the bulk collectionand packaging of suspicious visible powders that are suspectedbiological ag
8、ents and toxins from solid nonporous surfaces.Allsamples suspected to be biological agents and toxins onnonporous surfaces should be collected according to SampleCollection Method A and sent to an LRN reference laboratoryfor confirmatory testing.1.4 Sample Collection Method B covers swab sampling of
9、residual suspicious powders that are suspected biologicalagents and toxins from solid nonporous surfaces. Swabsamples can be used for on-site biological assessment; howeverresults from on-site biological assessments are not definitive;confirmatory testing by the LRN reference laboratory isnecessary
10、to make public health decisions.1.5 These practices incorporate reference guidance forpackaging and transport 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
11、suspected biological agents and toxins andhave been field screened according to reference guidance forexplosive hazard, radiological hazard, and other acute chemicalhazards.1.7 The values stated in SI units are to be regarded asstandard. The values given in parentheses are for informationonly.1.8 Th
12、is standard does not purport to address all of thesafety concerns associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety andhealth practices and determine the applicability of regulatorylimitations prior to use.1.9 This international standard wa
13、s developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenc
14、ed Documents2.1 ASTM Standards:31These practices are under the jurisdiction of ASTM Committee E54 onHomeland Security Applications and are the direct responsibility of SubcommitteeE54.01 on CBRNE Sensors and Detectors.Current edition approved May 15, 2017. Published June 2017. Originallyapproved in
15、2006. Last previous edition approved in 2010 as E2458 10. DOI:10.1520/E2458-17.2The CDC Laboratory Response Network is the network responsible forhandling clinical specimens and environmental samples containing suspectedbiothreat agents.3For referenced ASTM standards, visit the ASTM website, www.ast
16、m.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis intern
17、ational standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Comm
18、ittee.1E2770 Guide for Operational Guidelines for Initial Responseto Suspected Biological Agents and ToxinsF2412 Test Methods for Foot ProtectionF2413 Specification for Performance Requirements for Pro-tective (Safety) Toe Cap Footwear2.2 Federal Government Regulations:418 USC 178 Prohibitions with
19、respect to biological weaponsDOT 49 CFR, Parts 171-180 Hazardous Materials Regula-tionsDOT - 49 CFR 172 Subpart H, Transportation TrainingDOT - 49 CFR 173 General Requirements for Shipmentsand PackagingsDOT - 49 CFR 178 Specifications for PackagingsEPA - 40 CFR 300 National Oil and Hazardous Substan
20、cesPollution Contingency Plan (NCP)EPA - 40 CFR 311 Worker ProtectionNRC - 10 CFR 20 Standards for Protection against RadiationNIOSH - 42 CFR 84 Respiratory Protective DevicesOSHA - 29 CFR 1910 Subpart Z and 29 CFR 1926 SubpartZ Toxic and Hazardous SubstancesOSHA - 29 1910.1096 and 29 CFR 1926.53 Io
21、nizing Radia-tionOSHA - 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 - CPL 02-02-073 Inspection Procedures for
22、 29 CFR1910.120 and 1926.65, Paragraph (q): Emergency Re-sponse to Hazardous Substance ReleasesNIOSH Publication No. 2009-132 Recommendations for theSelection and Use of Respirators and Protective Clothingfor Protection Against Biological AgentsFBI Laboratory Publication Handbook of Forensic Service
23、s2013FBI-DHS-HHS/CDC Coordinated Document Guidance onInitial Response to a Suspicious Letter/Container with aPotential Biological threat, November 2, 2004CDC/NIOSH Surface Sampling Procedures for Bacillus an-thracis Spores from Smooth, Non-porous Surfaces, April26, 20125DHS Framework for a Biothreat
24、 Field Response MissionCapability, April 20116Sandia National Laboratories SAND2005-3237 (LBNL-54973 (II) Guidelines to Improve Airport PreparednessAgainst Chemical and Biological Terrorism72.4 NFPA Standards:8NFPA 472 Standard for Competence of Responders to Haz-ardous Materials/Weapons of Mass Des
25、truction Incidents,2013 EditionNFPA1994 Standard on Protective Ensembles for Chemical/Biological Terrorism Incidents2.5 IATA Standards:9IATA PI 602 Infectious Diseases (Infectious Substances)IATA PI 650 Shipping of Diagnostic SamplesIATA DGR 46th Edition, 2005IATA DGR Addendum I, January 2005IATA DG
26、R Addendum II, March 2005IATA DGR Addendum III, July 20052.6 ANSI Standards:10ANSI 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 Ameri
27、can National Standard Practices forRespiratory 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/Compressed
28、 Gas Association, CGA G-7.1-1997 Com-modity Specification for Air2.7 IAFC Guidance:11Model Procedures for Responding to a Package with Sus-picion of a Biological Threat, October 20083. Terminology3.1 Definitions:3.1.1 aseptic technique, noperation or performance of aprocedure or method under careful
29、ly controlled conditions toreduce the risk of exposure and prevent the introduction ofunwanted material/matter (contamination) into a sample.3.1.2 biological agent, nany microorganism (includingbut not limited to, bacteria, viruses, fungi, rickettsiae, orprotozoa), or infectious substance, or any na
30、turally occuring,bioengineered or synthesized component of any such microor-ganism or infectious substance, 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 materi
31、al of any kind; or (3)deleterious alteration of the environment. 18 USC 1783.1.3 bulk powder, na visible powder, at least approxi-mately 5 mL (1 teaspoon) in volume amassed or dispersed over4Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop:
32、 SDE, Washington, DC 20401, and also availableonline from Occupational Safety and Health Administration (www.osha.gov).5Available from http:/www.cdc.gov/niosh/topics/emres/surface-sampling-bacillus-anthracis.html.6Available from http:/www.hsdl.org/?view&did=767721.7Available from http:/share-ng.sand
33、ia.gov/news/resources/releases/2005/images/unlsand-2005-3237.pdf.8Available from National Fire Protection Association (NFPA), 1 BatterymarchPark, Quincy, MA 02269-9101.9Available from the International Air Transport Association, 800 Place Victoria,PO Box 113, Montreal-H4Z 1M1, Quebec, Canada.10Avail
34、able from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.11Available from International Association of Fire Chiefs (IAFC), 4025 FairRidge Drive, Suite 300 Fairfax, VA 22033, http:/www.iafc.org.E2458 172a limited area (optimally, area sh
35、ould be less than 20 by 20 cm(approximately 8 by 8 in.).3.1.4 chain 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
36、 workersare unlikely to be exposed to hazardous substances or danger-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 Discussi
37、onConfirmatory analysis of a biologicalagent for public health action can be performed only by anLRN national or reference laboratory.3.1.7 decontamination, nthe physical or chemical process,or both, of reducing and preventing the spread of contaminantsfrom people, animals, the environment, or equip
38、ment involvedat hazardous materials/weapons of mass destruction (WMD)incidents. NFPA3.1.8 field screening, nfield measurements utilized earlyin the response to define and characterize the potential hazardspresent, including corrosive, flammable, volatile, radioactive,or oxidizer hazards, and to supp
39、ort tactical decision making toaddress operational safety measures.3.1.8.1 DiscussionField screening does not include mea-surements of biological properties, which is termed on-sitebiological assessments (see 3.1.12).3.1.9 hazard, nsomething that is potentially dangerous orharmful, often the root ca
40、use 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 02-02-071 Directive3.1.11 incident commander (IC), nthe individual
41、 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 is respon-sible for the management of all incident operat
42、ions 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), nequipmentprovided to shield or isolate a person from the c
43、hemical,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 substance or agent, orthe presence of signatures of a subst
44、ance or agent.3.1.15 risk, nthe probability of suffering a loss or harm orinjury; peril.3.1.16 toxin, nthe toxic material or product of plants,animals, microorganisms (including but not limited to,bacteria, viruses, fungi, rickettsiae, or protozoa), or infectioussubstances, or a recombinant or synth
45、esized molecule, what-ever their origin and method of production, and includes: (1)any poisonous substance or biological product that may beengineered as a result of biotechnology produced by a livingorganism; or (2) any poisonous isomer or biological product,homolog, or derivative of such a substan
46、ce (18 USC 178).3.1.17 threat, nan indication of possible violence, harm,or danger and may include an indication of intent andcapability. NIMS3.1.18 warm zone, nthe transition area between the Ex-clusion Zone (ExZ or hot zone) and the Support Zone (SZ orcold zone) used to reduce and limit the amount
47、 of contamina-tion on people and equipment, and in the air, water, and soilthat may be transferred into nonhazardous areas; the CRZcontains decontamination facilities, and functions as a bufferzone surrounding the ExZ; also known as the contaminationreduction zone or CRZ. CPL 02-02-071 Directive3.1.
48、19 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 peoplethrough the release, dissemination, or impact of (1) toxic orpoisonous chemicals or their precursors; (2) a disease organ-ism; or
49、 (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 ANSIAmerican 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 of Transportation3.2.10 EOCEmergency Operations Center3.2.11 EPAEnviron