ASTM E2590-2015 Standard Guide for Conducting Hazard Analysis-Critical Control Point (HACCP) Evaluations《执行危害分析和关键控制点 (HACCP) 评估的标准指南》.pdf

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1、Designation: E2590 15Standard Guide forConducting Hazard Analysis-Critical Control Point (HACCP)Evaluations1This standard is issued under the fixed designation E2590; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last

2、 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 This guide describes a stepwise procedure for usingexisting information, and if available, supporting field andlaboratory

3、data concerning a process, materials, or productspotentially linked to adverse effects likely to occur in theenvironment as a result of an event associated with a processsuch as the dispersal of a potentially invasive species or therelease of material (for example, a chemical) or its derivativeprodu

4、cts to the environment. Hazard Analysis-Critical ControlPoint (HACCP) evaluations were historically linked to foodsafety (Hulebak and Schlosser W. 2002 (1);2Mortimer andWallace 2013 (2), but the process has increasingly foundapplication in planning processes such as those occurring inhealth sciences

5、 ; Quattrin et al. 2008 (3); Hjarno et al. 2007 (4);Griffith 2006 (5) or; Noordhuizen and Welpelo 1996 (6), innatural resource management (US Forest Service 2014 a,b,c (7,8, 9), (US EPA, 2006 (10); see alsohttp:/www.fws.gov/ fisheries/ans/ANS-HACCP.html; http:/www.haccp-nrm.org/;or http:/www.waterbo

6、ards.ca.gov/water_issues/programs/swamp/ais/prevention_planning.shtml (last accessed June 16, 2014)or in supporting field operations wherein worker health andnatural resource management issues intersect (see, forexample,http:/www.haccp-nrm.org/plans/nm/negrito.pdf related to field operationsoccurrin

7、g in areas associated with incidence of hantavirus; (last accessed June15, 2014)1.2 HACCP evaluation is a simple linear process or anetwork of linear processes that represents the structure of anyevent; the hazard analysis (HA) depends on the data qualityand data quantity available for the evaluatio

8、n process, espe-cially as that relates to critical control points (CCPs) charac-terized in completing HACCP. Control measures target CCPsand serve as limiting factors or control steps in a process thatreduce or eliminate the hazards that initiated the HACCPevaluation. The main reason for implementin

9、g HACCP is toprevent problems associated with a specific process, practice,material, or product.1.3 This guide assumes that the reader is knowledgeable inspecific resource management or engineering practices used aspart of the HACCP process. A list of general references isprovided for HACCP and impl

10、ementation of HACCP andsimilar methods, as those apply to environmental hazardevaluation, natural resource management, and environmentalengineering practices (11-26).1.4 This guide does not describe or reference detailedprocedures for specific applications of HACCP, but describeshow existing informa

11、tion or other empirical data should beused when assessing the hazards and identifying CCPs poten-tially of use in minimizing or eliminating specific hazards.Specific applications of HACCP evaluation are included asannexes to this guide, which include implementation ofHACCP in resource management pra

12、ctices related to controland mitigation of invasive species or disease agents primarilyof concern for managing fish and wildlife.1.5 HACCP evaluation has a well developed literature in,for example, food science and technology, and in engineeringapplications (see, for example, (11, 12, 13, 15, 17). A

13、s aresource management tool, HACCP is relatively recent inapplication to the analysis of hazards to aquatic, wetland, andterrestrial habitats and the organisms occupying those habitats.(see, for example, US Forest Service 2014 a,b,c (7, 8, 9); seealso http:/www.haccp-nrm.org/ last accessed June 16,

14、2014).Most of the guidance provided herein is qualitative rather thanquantitative, although quantitative methods should be appliedto any hazard analysis when possible. Uncertainties associatedwith the analysis should also be characterized and incorporatedinto the HACCP evaluation when possible (see,

15、 for example,(11, 27-38).1.6 This standard provides guidance for assessing hazardwithin a generalized framework that may be extended tospecific environmental settings, such as that detailed in E1023for aquatic habitats (Guide for Assessing the Hazard of aMaterial to Aquatic Organisms and Their Uses)

16、. This standard1This guide is under the jurisdiction ofASTM Committee E50 on EnvironmentalAssessment, Risk Management and Corrective Action and is the direct responsibil-ity of Subcommittee E50.47 on Biological Effects and Environmental Fate.Current edition approved Jan. 1, 2015. Published April 201

17、5. Originallyapproved in 2008. Last previous edition approved in 2009 as E259009. DOI:10.1520/E2590-15.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. U

18、nited States1does not provide guidance on how to account for socio-economic or political considerations that influence the specifi-cation of the acceptability of risk associated with the hazard,particularly when HACCP is implemented and CCPs areconsidered within contemporary risk-based decision-maki

19、ngprocesses. Judgments concerning acceptability are outside thescope of this guide, but available guidance from ASTM isapplicable to this process (see E2348 Standard Guide forFramework for a Consensus-based Environmental Decision-making Process).1.7 This guide is arranged as follows:SectionScope 1Re

20、ferenced Documents 2Descriptions of Terms Specific to This Standard 3Summary of Guide 4Significance and Use 5Basic Concepts of HACCP and Detailed Characterizationof HACCP6HACCP Applied to Prevention and Control of Invasive Species Annex A1HACCP-Derived Decontamination Procedures MitigatingEquipment-

21、Mediated Transfers of Invasive Aquatic Biota,Principally Mussel SpeciesAnnex A2HACCP-Derived Decontamination Procedures for ControllingEquipment-Mediated Transfers of Disease Agents of AquaticBiota, Principally Infectious Amphibian DiseasesAnnex A31.8 This standard does not purport to address all of

22、 thesafety concerns, if any, associated with its use and theimplementation of HACCP. It is the responsibility of the user ofthis standard to establish appropriate safety and health prac-tices and determine the applicability of regulatory limitationsprior to use.2. Referenced Documents2.1 ASTM Standa

23、rds:3E943 Terminology Relating to Biological Effects and Envi-ronmental FateE1023 Guide for Assessing the Hazard of a Material toAquatic Organisms and Their UsesE1391 Guide for Collection, Storage, Characterization, andManipulation of Sediments for Toxicological Testing andfor Selection of Samplers

24、Used to Collect Benthic Inver-tebratesE2348 Guide for Framework for a Consensus-based Envi-ronmental Decision-making Process3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 control, vto take all necessary actions to ensure andmaintain compliance with criteria established in the

25、 HACCPplan.3.1.2 control, na state wherein correct procedures arebeing followed and criteria are being met.3.1.3 control measureany action and activity that can beused to prevent or eliminate a hazard or reduce it to anacceptable level.3.1.4 corrective actionany action to be taken when theresults of

26、 monitoring at the CCP indicate a loss of control.3.1.5 critical control point (CCP)a step at which controlcan be applied and is essential to prevent or eliminate a hazardor reduce it to an acceptable level.3.1.6 critical limita criterion which separates acceptabil-ity from unacceptability.3.1.7 dev

27、iationfailure to meet a critical limit.3.1.8 flow diagrama systematic representation of the se-quence of steps or operations of a system or process, includingthe production or manufacture of a materials or products.3.1.9 HACCP (Hazard Analysis-Critical Control Point)asystem which identifies, evaluat

28、es, and controls hazards whichare significant for a wide range of natural resource manage-ment and environmental engineering applications.3.1.10 HACCP plana document prepared in accordancewith the principles of HACCP to ensure control of hazards.3.1.11 hazarda biological, chemical or physical agent

29、orcondition with the intrinsic capacity to cause an unwanted oradverse effect in an exposed system.3.1.12 hazard analysis (HA)the process of collecting andevaluating data and information on hazards and conditionsleading to their presence and necessary to include in a HACCPplan.3.1.13 monitorthe act

30、of conducting a planned sequenceof observations or measurements of control parameters toassess whether a critical control point is under control.3.1.14 stepa point, procedure, operation or stage in aprocess.3.1.15 validationobtaining evidence that the elements ofthe HACCP plan are effective.3.1.16 v

31、erificationthe application of methods, procedures,tests and other evaluations, in addition to monitoring todetermine compliance with the HACCP plan.3.2 For definitions of other terms used in this guide, refer toTerminology E943 and references cited herein.4. Summary of Guide4.1 HazardAnalysis-Critic

32、al Control Point (HACCP) evalu-ation has become increasingly applied to natural resourcemanagement and environmental engineering problems, par-ticularly as hazards may be managed, for example, with respectto the safety of processes or release of materials or products tothe environment. HACCP should

33、be an integral part of man-agement practices focused on engineering or resource manage-ment practices used to develop aquatic, wetland, and terrestrialhabitats for human use (for example, agriculture or construc-tion activities) or to enhance habitats for fish and wildlife.HACCPis a systematic and p

34、reventive approach that addressesbiological, chemical and physical hazards through anticipationand prevention, rather than through end-product inspection andtesting or retrospective engineering solutions necessitated be-cause of previous undertakings. The HACCP system is in-tended for assessing and

35、managing risks and safety concernsassociated with a wide range of materials, products, and3For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Sum

36、mary page onthe ASTM website.E2590 152management practices with an emphasis on a total systemsapproach to improve environmental quality. This standardcould be used in conjunction with existing ASTM standardssuch as Guides E1023 and E2348. HACCP emphasizes controlof a process as far upstream in the p

37、rocessing system aspossible by utilizing operator control or continuous monitoringtechniques, or a combination of both, at critical control points.The HACCP system uses the approach of controlling criticalpoints in any process to reduce or eliminate risks and preventsafety problems from developing.

38、The identification of specifichazards and measures for their control to ensure the safety ofa process, material, or product through prevention and reducesthe reliance on end-product inspection and testing (forexample, for agrichemicals), remedial measures (for example,related to construction practic

39、es), or mitigation measures aspart of a control program (for example, quarantine or disinfec-tion for control of invasive species) are integral components ofany HACCPsystem.Any HACCPsystem should be capable ofaccommodating change, such as advances in equipment designor developing alternative resourc

40、e management practices,changes in processing procedures, or technological develop-ments.4.2 This guide describes an iterative procedure for assessinghazard and characterizing CCPs. Unavailable, yet necessaryinformation concerning the hazard and the process generatingthat hazard should be identified

41、and characterized through astepwise evaluation that details the hazard and specifies criticalpoints that may serve to control the process, and minimize oreliminate hazard. At the end of any iteration of the HACCPprocess, specific CCPs that reduce likelihood of hazard may beidentified, or the availab

42、le data related to the hazard and theprocess generating that hazard may be judged as being insuf-ficient to adequately characterize hazard or CCPs. In the latterinstance, additional data or information should be identifiedand obtained, so that HA and CCPs can be reassessed. Theprocess is repeated un

43、til the hazard is adequately characterizedand CCPs are characterized in order to reduce likelihood thathazard is realized.4.3 Three annexes are also included with this standardguide.4.3.1 Annex A1 focuses on implementation of HACCPwithin the context of natural resource management, principallythat pr

44、ocess developed for control of invasive species;principally, prevention of species invasions, but alsomitigation, reduction, or eradication if such events haveoccurred. This annex summarizes extension of the generalguidance contained within the standard guide to a specificapplication of the HACCP pr

45、ocess that may serve as a “standalone” document to support the development of species-specific or practice-specific HACCP plans linked to invasivespecies. The relationships between the generalized HACCPprocess summarized in the standard guide and its specificimplementation in this annex should be co

46、nsidered in adaptingHACCPplans to changing environmental conditions that mightdevelop and alter hazards through time. Tasks outlined in thestandard guide have been variously incorporated into theimplementation-specific five-step HACCPprocess summarizedin this annex.Additionally, in recognizing the d

47、ynamic processassociated with species invasions, users of this stand-aloneannex would benefit from consultation with online resourcesthat directly complement this implementation of HACCP(http:/www.haccp-nrm.org/ last accessed June 16, 2014).4.3.2 Annex A2 continues implementation of HACCPlinked to i

48、nvasive-species management issues with a particularfocus on decontamination procedures intended to mitigate orreduce hazards associated species transfers stemming fromfield operations. Given the increasing occurrence of dispersaland establishment of invasive species in previously unoccupiedterrestri

49、al or aquatic habitats, various organizations have de-veloped procedures for managing unintended human-aideddispersal events. For aquatic invasive species (AIS) HACCPorprincipals characteristic of the HACCPprocess reflected in thisannex guides the development of mitigation practices intendedto prevent the spread of AIS with a primary focus on NewZealand mudsnail (Potamopyrgus antipodarum), quagga mus-sel (Dreissena rostriformis bugensis) or zebra mussel (Dreis-sena polymorpha). These invasive molluscs are not easilyobserved in field settings; hence, unintend