ASTM E2590-2009 Standard Guide for Conducting Hazard Analysis-Critical Control Point (HACCP) Evaluations《进行危害分析和关键控制点(HACCP)评价的标准指南》.pdf

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1、Designation: E2590 09Standard 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.1.2 Hazard analysis-critical control point (HACCP) evalua-tion is a simple linear process or a network of linear processesthat represents the structure of any event; the hazard analysis(HA) depends on the data quality and data quantity availablefor the evaluation process, espe

5、cially as that relates to criticalcontrol points (CCPs) characterized in completing HACCP.Control measures target CCPs and serve as limiting factors orcontrol steps in a process that reduce or eliminate the hazardsthat initiated the HACCP evaluation. The main reason forimplementing HACCP is to preve

6、nt problems associated witha 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 implementation of HACC

7、P andsimilar methods, as those apply to environmental hazardevaluation, natural resource management, and environmentalengineering practices (8, 11-17, 20, 21, 24, 27, 28, 30-32).21.4 This guide does not describe or reference detailedprocedures for specific applications of HACCP, but describeshow exi

8、sting information 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 standard, which include implementation ofHACCP in resourc

9、e management practices related to invasivespecies control and mitigation.1.5 HACCP evaluation has a well developed literature in,for example, food science and technology, and in engineeringapplications (see, for example, 8, 11, 12, 14, 16). As a resourcemanagement tool, HACCP is relatively recent in

10、 application tothe analysis of hazards to aquatic, wetland, and terrestrialhabitats and the organisms occupying those habitats. Most ofthe guidance provided herein is qualitative rather than quanti-tative, although quantitative methods should be applied to anyhazard analysis when possible. Uncertain

11、ties associated withthe analysis should also be characterized and incorporated intothe HACCP evaluation when possible (see, for example, 1-10,18, 19, 29).1.6 This standard provides guidance for assessing hazardbut does not provide guidance on how to take into accountsocial or political consideration

12、s that influence the specificationof the acceptability of the hazard. Judgments concerningacceptability are outside the scope of this guide, but availableguidance from ASTM is applicable to this process (see E2348Standard Guide for Framework for a Consensus-based Envi-ronmental Decision-making Proce

13、ss).1.7 This guide is arranged as follows:SectionScope 1Referenced 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 A11.8

14、 This standard does not purport to address all of thesafety concerns, if any, associated with its use and theimplementation of HACCP. It is the responsibility of the user of1This guide is under the jurisdiction of ASTM Committee E47 on BiologicalEffects and Environmental Fate and is the direct respo

15、nsibility of SubcommitteeE47.04 on Environmental Fate and Transport of Biologicals and Chemicals.Current edition approved Nov. 1, 2009. Published November 2009. Originallyapproved in 2008. Last previous edition approved in 2008 as E259008.DOI:10.1520/E2590-09.2The boldface numbers in parentheses ref

16、er to the list of references at the end ofthis standard.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.this standard to establish appropriate safety and health prac-tices and determine the applicability of regulatory limitationsprio

17、r to use.2. Referenced Documents2.1 ASTM Standards:3E943 Terminology Relating to Biological Effects and Envi-ronmental FateE1023 Guide for Assessing the Hazard of a Material toAquatic Organisms and Their UsesE1609 Guide for Development and Implementation of aPollution Prevention ProgramE2348 Guide f

18、or 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 HACCPplan.3.1.2 control, na state wherein correct

19、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 monitoring at the CCP indicate a loss of control.3

20、.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 deviationfailure to meet a critical limit.3.1.8 flow d

21、iagrama systematic representation of thesequence of steps or operations of a system or process,including the production or manufacture of a materials orproducts.3.1.9 HACCPa system which identifies, evaluates, andcontrols hazards which are significant for a wide range ofnatural resource management a

22、nd environmental engineeringapplications.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 orcondition with the intrinsic capacity to cause an unwanted oradverse effect in an exposed syste

23、m.3.1.12 hazard analysisthe 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 of conducting a planned sequenceof observations or measurements of control parameters toassess whether

24、 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 verificationthe application of methods, procedures,tests and other evaluations, in addition to monitori

25、ng 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-Critical Control Point (HACCP) evalu-ation has become increasingly applied to natural resourcemanagement and

26、 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 be an integral part of man-agement practices focused on engineering or resource manage-ment practices

27、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.HACCP is a systematic and preventive approach that addressesbiological, chemical and physical hazards through anticipationand pr

28、evention, 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 managing risks and safety concernsassociated with a wide range of materials, products, andmanagement

29、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, E2348 and E1609. HACCP emphasizescontrol of a process as far upstream in the processing system aspossible by utilizing o

30、perator 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. The identification of specifichazards and

31、measures for their control to ensure the safety ofa process, material, or product through prevention and reducesthe reliance on end-product inspection and testing (for ex-ample, for agrichemicals), remedial measures (for example,related to construction practices), or mitigation measures aspart of a

32、control program (for example, quarantine or disinfec-tion for control of invasive species) are integral components ofany HACCP system.Any HACCP system should be capable ofaccommodating change, such as advances in equipment designor developing alternative resource management practices,changes in proc

33、essing 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 and characterized through astepwise ev

34、aluation 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 available data related to the hazard and the3

35、For 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 Summary page onthe ASTM website.E2590 092process generating that hazard may be judged as being

36、 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 until the hazard is adequately characterizedand CCPs are characterized in order to reduce li

37、kelihood thathazard is realized.5. Significance and Use5.1 HACCP is a proactive management tool that serves toreduce hazards potentially expressed as adverse biological orenvironmental effects, for example, associated with chemicalreleases, changes in natural resource or engineering practicesand the

38、ir related impacts, and accidental or intentional releasesof biological stressors such as invasive species.5.2 Sequential implementation of HACCP and feedback inthe iterative HACCP process allows for technically-basedjudgments concerning, for example, natural resources or theuse of natural resources

39、. Implementing the HACCP processserves to reduce adverse effects potentially associated with aparticular material or process, and provides guidance fortesting and evaluation of products or processes, through apre-emptive procedure focused on information most pertinentto a systems characterization. F

40、or example, identification ofCCPs assure that processes and practices can be managed toachieve hazard reduction. For different processes and situa-tions, HA may be based on substantially different amounts andkinds of, for example, biological, chemical, physical, andtoxicological data, but the identi

41、fication of CCPs serving toreduce hazard is key to successful implementation of HACCP.5.3 HACCP should never be considered complete for alltime, and continuing reassessment is a characteristic ofHACCP evaluations, especially if there should be changes in,for example, production volumes of a material

42、, or its use ordisposal increases, new uses are discovered, or new informa-tion on biological, chemical, physical, or toxicological proper-ties becomes available. Similarly, HACCP should be consid-ered an ongoing process serving as a key component inengineering practices, for example, related to con

43、structionactivities and land-use changes, and natural resource manage-ment practices, for example, related to habitat use, enhance-ment, and species introductions such as fish-stocking pro-grams. Periodic review of a systems performance will helpassure that new circumstances and information receive

44、promptand appropriate attention.5.4 In many cases, consideration of adverse effects shouldnot end with completion of the HA and identification of CCPskey to the development of control measures. Additional stepsmay subsequently include risk assessment, and decisionsconcerning acceptability of identif

45、ied hazards and risks, andmitigation actions potentially applicable to the process orpractice that initially motivated HACCP.6. Basic Concepts of Hazard Analysis-Critical ControlPoint (HACCP) Evaluation6.1 Overview of HACCP EvaluationThe basic principleof HACCP relies on system characterization and

46、a repetitive oriterative evaluation of that system and its attendant outcomes.When available data to characterize a system are inadequateand CCPs can not be adequately characterized, data needs areidentified and HACCP reiterated. The process is repeated untilHA is adequate and CCPs are clearly ident

47、ified. The HACCPsystem systematically identifies hazards and measures for theircontrol to ensure the safety of any process, but especially thoseinvolving engineering or management practices that manipu-late materials, products, or systems potentially associated withadverse effects directly or indire

48、ctly associated with thosemanipulations. HACCP is a tool to assess hazards and establishcontrol systems that focus on prevention rather than relyingmainly on end-product testing and inspection. Any HACCPsystem is capable of accommodating change, such as advancesin equipment design, processing proced

49、ures or technologicaldevelopments. This section reviews the 12 tasks in the appli-cation of HACCP, including the seven HACCP principles. Itemphasizes the importance of standards and guidelines as abasis for developing the HACCP plan.6.2 Principles of the HACCP SystemThe HACCP systemconsists of seven principles that guide any evaluation.6.2.1 Conduct a hazard analysis. Identify the potentialhazard(s) associated with at all stages or steps within a systemor process of concern within a system. Assess the likelihood ofoccurrence of the hazard(s) and identify the measu