FDA水产品HACCP法规分析

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 A Definitions 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） Require

2、ments of Imported Products 对进对进口产品的要求口产品的要求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

3、 运输工具 Retail Establishments, Including 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 Defi

4、nitions: Fish 水产 - all forms of aquatic animal life intended 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

5、(GMPs)Ties GMPs HACCP regulationsFDA水产品水产品HACCP法规法规 Includes all seven 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

6、Critical Limit Deviation Occurs 纠正措施 Establishing a Record-Keeping System 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 th

7、at I can apply to control these hazards? Hazards are defined as physical, microbiological and/or chemical 物理、化学物理、化学与生物危害与生物危害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

8、 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FDA水产品水产品HACCP法规法规 The HACCP Plan Each Location Each Product HACCP计划是针对于每一计划是针对于每一个加工地点、每一种产品个加工地点、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 食品安全危食品安全危害害 The Critical Control Points of Each Hazard

9、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 监测程监测程序序 The Required 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 验证程验证程序序 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

10、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 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

11、where controls need to be in place Critical Limits 关键限值 - A limit expressed as a value (i.e. time or temperature) listed 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

12、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 Sou

13、rces 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 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 Instrument

14、s (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 Analysis - 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

15、 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 Information 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 Initial

16、s 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 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

17、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 Critical 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: Trai

18、ning 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

19、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 :Prerequisite to HACCP Monitoring 监测 Records 记录 Corrections 纠偏FDA水产品水产品HACCP法规法规 Sanitation - 8 Areas :S

20、SOP至少包括8个方面 Safety of Water That Comes in Contact With Food, Food Contact Surfaces, or Used to Make Ice Condition of Food Contact Surfaces Prevention of Cross Contamination Exclusion of Pests Maintenance of Hand Washing, Hand Sanitizing and Toilet Facilities Protection From Contaminants Proper Label

21、ing, Storage and Use of Toxic Compounds Control 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 HACCP 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

22、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 REQUIREMENTS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

23、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 or representative of the foreign owner or consignee at the time

24、 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 Import From Countries With An MOU从与FDA签署相应MOU的国家进口Or或 Impleme

25、nt 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 Step 确认步骤HACCP REGULATION OVERVIEWIMPORTER REQUIREMENTSAffirm

26、ative 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-product testing and guarantee 最终产品检测和保证书 Obtaining a conti

27、nuing 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 ProcessingDrugs used for: 药物用于药物用于 Treating and preventing dis

28、ease 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 用药品种用药品种 Approved dosage 剂量剂量 Approved route of transmissi

29、on 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 Sulfamerazine Sulfadimethoxine/ormetoprim Office of SeafoodAq

30、uaculture 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 ShellfishShellfish AuthorityGovernment authority re

31、sponsible 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 classification Harvesting control Processing plant and

32、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 ShellfishImport of Raw Molluscan Shellfish Raw mo

33、lluscan 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 include: Canada New Zealand Chile South Korea

34、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, harvesting, processing, labeling, and shipping o

35、f 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 for pathogenic microorganisms will be ade

36、quate 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 Countries that do not currently have a Memora

37、ndum 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 only if the processor has controlled t

38、he 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 of Control Monitoring of shellfish m

39、eats 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 Authority must have authority to clos

40、e 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 Natural Toxins Paralytic Shellfish

41、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 ShellfishControl of Natura

42、l 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 ShellfishControl of

43、 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 ChemicalsCooked mo

44、lluscan 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 area

45、sOR 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 levels 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 contami