FDA水产品HACCP法规分析.ppt

《FDA水产品HACCP法规分析.ppt》由会员分享，可在线阅读，更多相关《FDA水产品HACCP法规分析.ppt（75页珍藏版）》请在得力文库 - 分享文档赚钱的网站上搜索。

1、FDA水产品水产品HACCP 法规法规-21 CFR 123,1240FDA水产品水产品HACCP 法规法规Subpart ADefinitions 定义定义Good Manufacturing Practices（GMP）Hazard Analysis&Hazard Analysis Critical Control Point plan（HACCP计划）计划）Corrective Actions 纠正措施纠正措施Verification 验证验证Records 记录记录Training 培训培训Sanitation 卫生卫生（SSOP）Requirements of Imported Pr

2、oducts 对进口产品对进口产品的要求的要求FDA水产品水产品HACCP法规法规Subpart B -Smoked Fish 烟熏鱼FDA水产品水产品HACCP 法规法规Subpart C -Raw Molluscan Shellfish 生的软体贝类FDA水产品水产品HACCP法规法规HACCP 只适用于:食品安全的危害FDA水产品水产品HACCP法规法规Subpart A 适用于所有加工者FDA水产品水产品HACCP法规法规不受法规制约的设施:Fishing Vessels 捕捞船 Transportation Vehicles 运输工具Retail Establishments,Inc

3、luding Restaurants 包括餐馆在内的零售设施 FDA水产品水产品HACCP法规法规Definitions:Processing 加工-Handling,storing,preparing,heading,eviscerating,shucking,freezing,changing form,manufacturing,preserving,packing,labeling,dockside unloading,or holding.FDA水产品水产品HACCP法规法规Definitions:Fish 水产-all forms of aquatic animal life in

4、tended for human consumption;including amphibians,mollusks,and roe.FDA水产品水产品HACCP法规法规Definitions:Fishery Products 水产制品-any human food product in which fish is the characterizing ingredient.FDA水产品水产品HACCP法规法规Good Manufacturing Practices(GMPs)Ties GMPs HACCP regulationsFDA水产品水产品HACCP法规法规Includes all s

5、even principles of HACCP 七个原则或原理:Conducting a Hazard Analysis 危害分析Identifying Critical Control Points(CCP)确定关键控制点Establishing Critical Limits 建立关键限值Monitoring Each CCP 监测每个CCP点Establishing Corrective Actions to be Taken When a Critical Limit Deviation Occurs 纠正措施Establishing a Record-Keeping System

6、记录保持系统Establishing Verification Procedures 验证程序 FDA水产品水产品HACCP法规法规Conducting a hazard analysis:Are there food safety hazards associated with my product that are reasonably likely to occur?Are there preventative measures that I can apply to control these hazards?Hazards are defined as physical,microb

7、iological and/or chemical 物理、化学与生物危害物理、化学与生物危害FDA水产品水产品HACCP法规法规Hazard must be one that is reasonably likely to occur 极可能发生的危害FDA水产品水产品HACCP法规法规No one way to do a hazard analysis 进行危害分析的途径很多Be certain to use the Guide 一定要使用指南 No hazards -No HACCP plan is necessary 没有（显著）危害，就不需要没有（显著）危害，就不需要HACCP计划计划

8、FDA水产品水产品HACCP法规法规The HACCP PlanEach LocationEach Product HACCP计划是针对于每一个计划是针对于每一个加工地点、每一种产品加工地点、每一种产品FDA水产品水产品HACCP法规法规HACCP计划必须包括:The Food Safety Hazard 食品安全危害食品安全危害The Critical Control Points of Each Hazard 每一个危害的关键控制点每一个危害的关键控制点The Critical Limits 关键限值关键限值The Monitoring Procedures 监测程序监测程序The Req

9、uired Records 要求的记录要求的记录A Corrective Action 纠正措施纠正措施The Verification Procedures 验证程序验证程序 FDA水产品水产品HACCP法规法规HACCP Plan -Hazards to be considered 要考虑到的危害:Natural Toxins 天然毒素Microbiological 微生物Chemical Pesticides 化学杀虫剂（农药）Drug Residues 药物（兽药）残留Unapproved Uses of Food and Color Additives 未经批准使用的食品添加剂和色素

10、Physical Hazards 物理的危害Decomposition Related to Safety 与安全有关的腐败 FDA水产品水产品HACCP法规法规HACCP Plan -Critical Control Points and Critical Limits:Critical Control Points 关键控制点-A point in processing where controls need to be in place Critical Limits 关键限值 -A limit expressed as a value(i.e.time or temperature)l

11、isted at a critical control point.FDA水产品水产品HACCP法规法规Monitoring Procedures 监测程序:What Will Be Monitored 监测什么？How Will Monitoring Be Done 怎样监测？Frequency of Monitoring 监测频率、时间？Who?谁负责监测？Where?在哪监测？FDA水产品水产品HACCP法规法规Corrective Action -Predetermined 预先确定好的纠正措施:Corrective Action Plans 纠正措施计划 FDA水产品水产品HACCP

12、法规法规Verification 验证-Reassessment 重新评估:Verify Plans No Less Than Once A Year 验证HACCP计划每年至少一次 FDA水产品水产品HACCP法规法规Verification -List Changes 以下改变必须验证:Raw Materials or Sources of Raw Materials 原料或原料来源Product Formulation 产品配方Processing Methods or Systems 加工方法或系统Finished Product Distribution 成品的配发Intended

13、Use of the Finished Product by Consumers 消费者对成品预期用途FDA水产品水产品HACCP法规法规Verification -Verifying Performance 验证的措施:Consumer Complaints 消费者投诉Calibrating Instruments(i.e.,thermometers)校准仪器Testing 检测Reviewing Records 审核记录 FDA水产品水产品HACCP法规法规Verification -Reassess Hazard Analysis 重新评估危害分析:Reassess Hazard Ana

14、lysis -Whenever There Is a Change 一旦有改变，就必须重新进行危害分析。FDA水产品水产品HACCP法规法规Records -Types 文件记录的类型:HACCP Plan HACCP计划Monitoring Records 监测记录Corrective Action Records 纠偏记录Verification Measures 验证记录Sanitation Records 卫生方面的记录Importer Verification Records 进口商验证记录 FDA水产品水产品HACCP法规法规Records -Required Informatio

15、n 记录的信息:Name and Location of Processor or Importer 加工者或进口商的名称和地点 Date and Time of Activity Being Recorded 被记录活动的日期和时间Signature or Initials of Person Making Record 记录人员的签名Product Identity and Code(when appropriate)产品名称和代码 FDA水产品水产品HACCP法规法规Records -Retention 记录保留的时间:Refrigerated Products -1 Year 冷藏产品

16、 一年Frozen Products -2 Years 冷冻产品 二年 FDA水产品水产品HACCP法规法规Records -Access:FDA Has Access to HACCP Records and Plans and may copy them(for domestic processors)FDA Has Access to Importer Records FDA有权检查有关记录，并进行复印。FDA水产品水产品HACCP法规法规Plan Contents (复习)HHACCP计划的内容包括：Hazards 危害Critical Control Points 关键控制点Crit

17、ical Limits 关键限值Corrective Actions 纠正措施Records 记录Verification 验证FDA水产品水产品HACCP法规法规Training -Options 培训方面的要求:Training in HACCP 参加相当的培训On-The Job Experience 有一定工作经验“The Seafood HACCP Alliance”美国水产品美国水产品HACCP联盟联盟 FDA水产品水产品HACCP法规法规Training -Choices:One Trained Employee 工作人员参加培训Trained Consultant 请培训过的专

18、家顾问FDA水产品水产品HACCP法规法规Training -Individual Shall 下列工作必须要有一定资格的人员来进行:Develop or Amend the HACCP Plan 制订或修改HACCP计划Reassess and/or Modify the HACCP Plan 重新评估、修改HACCP计划Reassess and Modify the Hazard Analysis 重新评估和修改危害分析Review All Records 审核所有的记录FDA水产品水产品HACCP法规法规Sanitation -Prerequisit HACCP的前提条件:Prerequ

19、isite to HACCPMonitoring 监测Records 记录Corrections 纠偏FDA水产品水产品HACCP法规法规Sanitation -8 Areas:SSOP至少包括8个方面Safety of Water That Comes in Contact With Food,Food Contact Surfaces,or Used to Make IceCondition of Food Contact SurfacesPrevention of Cross ContaminationExclusion of PestsMaintenance of Hand Washi

20、ng,Hand Sanitizing and Toilet FacilitiesProtection From ContaminantsProper Labeling,Storage and Use of Toxic CompoundsControl of Employee Health ConditionsFDA水产品水产品HACCP法规法规Sanitation -Monitoring Frequency:Monitoring Frequencies 监测频率Corrective Measures 纠正措施Records 记录Records are required even if no H

21、ACCP plan is required 即使没有即使没有HACCP计划，仍然要求计划，仍然要求SSOP记录记录FDA水产品水产品HACCP法规法规Sanitation -Handled Separately:Sanitation controls can be included in the HACCP plan.卫生控制可包含再卫生控制可包含再HACCP计划中。计划中。Sanitation controls can be handled outside of the HACCP plan.卫生控制可不包含在卫生控制可不包含在HACCP计划里。计划里。IMPORTER REQUIREMEN

22、TS对进口商的要求对进口商的要求CoverageGeneral Provisions 一般条款：All Processors 对所有加工者 Special Requirements for Importers 对进口商Special Provisions 特殊条款：Smoked Fish Raw Molluscan Shellfish Definitions 定义定义Importer 进口商-means either the U.S.owner or consignee at the time of entry into the United States,or the U.W.agent o

23、r representative of the foreign owner or consignee at the time of entry in the United States,who is responsible for ensuring that goods being offered for entry into the United States are in compliance with all laws affecting the importation Imports 21 CFR Part 123.12Importer Verification 进口商验证进口商验证

24、Import From Countries With An MOU从与FDA签署相应MOU的国家进口Or或 Implement Verification Procedures 实施进口商验证程序 -（可由有资格的第三方实施）Written Verification Procedures 书面的验证程序书面的验证程序 Product Specifications to ensure that the product is not injurious to health and not processed under insanitary conditions 产品说明书 Affirmative

25、Step 确认步骤HACCP REGULATION OVERVIEWIMPORTER REQUIREMENTSAffirmative Step Requirement-Choose at least one:任选其一任选其一 On-site visits by the importer 进口商现场检查 Obtaining the processors HACCP and sanitation records 得到加工者的HACCP计划和卫生方面的记录 Obtaining the processors HACCP plan and guarantee 得到加工者的HACCP计划和保证书 End-

26、product testing and guarantee 最终产品检测和保证书 Obtaining a continuing or lot-by-lot certification 得到连续的或逐批的证书（官方或第三方）Other verification methods其他验证方法Aquaculture Processing 养殖过程中的药物使用养殖过程中的药物使用Hazards associated with use of medications in feed or by direct administration Office of SeafoodAquaculture Proces

27、singDrugs used for:药物用于药物用于 Treating and preventing disease 治疗和预防疾病治疗和预防疾病 Controlling parasites 控制寄生虫控制寄生虫 Controlling reproduction 控制繁殖控制繁殖 Controlling growth 控制生长控制生长 Tranquilizing 镇静镇静 Office of SeafoodAquaculture ProcessingConditions for drug approval:Species for which the drug is approved 用用药品

28、种药品种 Approved dosage 剂量剂量 Approved route of transmission 用药途径用药途径 Approved frequency of use 用药频率用药频率 Approved indications for use 症状症状 Office of SeafoodAquaculture ProcessingDrugs approved by FDA:FDA批准的药物批准的药物 Chorionic Gonadotropin Formalin solution Tricaine methanesulfonate Oxytetracycline Sulfame

29、razine Sulfadimethoxine/ormetoprim Office of SeafoodAquaculture ProcessingLabels of approved drugs list the mandatory withdrawal times,where applicable.停药期停药期 Office of SeafoodAquaculture ProcessingTissue residue tolerances have been established for some drugs.组织残留限量组织残留限量 Office of SeafoodMolluscan

30、 ShellfishShellfish AuthorityGovernment authority responsible for enforcement of all regulatory requirements associated with shellfishMolluscan ShellfishShellfish defined as:Oysters Clams Mussels ScallopsMolluscan ShellfishRegulatory requirements of the Shellfish Authority include:Growing area class

31、ification Harvesting control Processing plant and procedure control Product labeling Storage,handling and packing Shipment controlMolluscan ShellfishHazards Associated With Shellfish:Pathogen microorganisms Natural Toxins from the harvest water Chemical contaminants from the harvest waterMolluscan S

32、hellfishImport of Raw Molluscan Shellfish Raw molluscan shellfish can only be imported into the United States from countries that have a current Memorandum of Understanding(MOU)with the United States Food and Drug Administration.Molluscan ShellfishImport of Molluscan Shellfish Current MOU countries

33、include:Canada New Zealand Chile South Korea Molluscan ShellfishControl of Pathogenic Microorganisms in Shellfish from MOU Countries For countries that currently have a MOU with FDA,the control strategy for pathogenic microorganisms is implementation of NSSP requirements to control the growing,harve

34、sting,processing,labeling,and shipping of molluscan shellfish.Molluscan ShellfishControl of Pathogenic Microorganisms in Shellfish from Non-MOU Countries For countries that DO NOT currently have a Memorandum of Understanding with FDA for importation of raw molluscan shellfish,the control strategy fo

35、r pathogenic microorganisms will be adequate cooking.Molluscan ShellfishControl of Pathogenic Microorganisms in Shellfish from Non-MOU Countries Cooking or pasteurization process must reduce the target organism to a non-detectable level.Molluscan ShellfishControl of Pathogenic Microorganisms Countri

36、es that do not currently have a Memorandum of Understanding with the United States for raw molluscan shellfish are NOT permitted to import raw shellfish into the United States.Molluscan ShellfishControl of Natural Toxins Cooked molluscan shellfish is permitted to be imported into the United States o

37、nly if the processor has controlled the hazards associated with natural toxins from the harvest water.Molluscan ShellfishControl of Natural Toxins Cooking will not eliminate or significantly reduce the level of natural toxins in shellfish meats.Molluscan ShellfishControl of Natural Toxins 2 methods

38、of Control Monitoring of shellfish meats from “key”locations in the growing areasOR Monitoring of shellfish meats on a lot-by-lot basis at the processing facility.Molluscan ShellfishControl of Natural Toxins If natural toxins are controlled by monitoring shellfish at the growing area,the Control Aut

39、hority must have authority to close the area from harvesting when unsafe levels are present in shellfish meats.Molluscan ShellfishControl of Natural Toxins There are four recognized shellfish poisoning syndromes resulting from natural toxins produced by marine algae.Molluscan ShellfishControl of Nat

40、ural Toxins Paralytic Shellfish Poisoning(PSP)Neurotoxic Shellfish Poisoning(NSP)Diarrhetic Shellfish Poisoning(DSP)Amnesic Shellfish Poisoning(ASP)Molluscan ShellfishControl of Natural Toxins Action Levels in Meats Paralytic Shellfish Poisoning-0.8 PPM(80ug/100g)saxitoxin equivalent.Molluscan Shell

41、fishControl of Natural Toxins Action Levels in Meats Neurotoxic Shellfish Poisoning-0.8 PPM(20 mouse units/100g)brevetoxin-2 equivalent.Molluscan ShellfishControl of Natural Toxins Action Levels in Meats Diarrhetic Shellfish Poisoning-0.2 PPM okadaic acid plus 35-methyl okadaic acid.Molluscan Shellf

42、ishControl of Natural Toxins Action Levels in Meats Amnesic Shellfish Poisoning-20 PPM domoic acid.Molluscan ShellfishControl of Natural Toxins Southern China-At risk for Paralytic Shellfish Poisoning Northern China-At risk for Diarrhetic Shellfish PoisoningMolluscan ShellfishControl of ChemicalsCoo

43、ked molluscan shellfish is permitted to be imported into the United States only if the processor has controlled the hazards associated with environmental chemical contaminants.Molluscan ShellfishControl of Chemicals2 methods of Control Monitoring of shellfish meats from “key”locations in the growing

44、 areasOR Monitoring of shellfish meats on a lot-by-lot basis at the processing facility.Molluscan ShellfishControl of ChemicalsIf chemical contaminants are controlled by monitoring shellfish at the growing area,the Control Authority must have authority to close the area from harvesting when unsafe l

45、evels are present in shellfish meats.Molluscan ShellfishControl of ChemicalsGuidance Levels in MollusksRefer to Table#9-1,Chapter 9 of FDAs Fish and Fisheries Products Hazards&Guide for tolerances and action levels for additional environmental chemical contaminates.For Additional Informationcontact:Millie Benjamin at the U.S.Food and Drug Administratione-mail:MBenjam1cfsan.fda.gov