1、FDAHACCP - 21 CFR 123, 1240,FDA水產(chǎn)品HACCP 法規(guī),Subpart A Definitions 定義 Good Manufacturing Practices （GMP） Hazard Analysis including amphibians, mollusks, and roe.,FDA水產(chǎn)品HACCP法規(guī),Definitions: Fishery Products 水產(chǎn)制品 - any human food product in which fish is the characterizing ingredient.,FDA水產(chǎn)品HACCP法規(guī),Good

2、 Manufacturing Practices (GMPs) Ties GMPs HACCP regulations,FDA水產(chǎn)品HACCP法規(guī),Includes all seven principles of HACCP 七個(gè)原則或原理: Conducting a Hazard Analysis 危害分析 Identifying Critical Control Points (CCP) 確定關(guān)鍵控制點(diǎn) Establishing Critical Limits 建立關(guān)鍵限值 Monitoring Each CCP 監(jiān)測(cè)每個(gè)CCP點(diǎn) Establishing Corrective Actio

3、ns to be Taken When a Critical Limit Deviation Occurs 糾正措施 Establishing a Record-Keeping System 記錄保持系統(tǒng) Establishing Verification Procedures 驗(yàn)證程序,FDA水產(chǎn)品HACCP法規(guī),Conducting a hazard analysis: Are there food safety hazards associated with my product that are reasonably likely to occur? Are there prevent

4、ative measures that I can apply to control these hazards?,Hazards are defined as physical, microbiological and/or chemical 物理、化學(xué)與生物危害,FDA水產(chǎn)品HACCP法規(guī),Hazard must be one that is reasonably likely to occur 極可能發(fā)生的危害,FDA水產(chǎn)品HACCP法規(guī),No one way to do a hazard analysis 進(jìn)行危害分析的途徑很多 Be certain to use the Guide

5、一定要使用指南,No hazards - No HACCP plan is necessary 沒有（顯著）危害，就不需要HACCP計(jì)劃,FDA水產(chǎn)品HACCP法規(guī),The HACCP Plan Each Location Each Product HACCP計(jì)劃是針對(duì)于每一個(gè)加工地點(diǎn)、每一種產(chǎn)品,FDA水產(chǎn)品HACCP法規(guī),HACCP計(jì)劃必須包括 : The Food Safety Hazard 食品安全危害 The Critical Control Points of Each Hazard 每一個(gè)危害的關(guān)鍵控制點(diǎn) The Critical Limits 關(guān)鍵限值 The Monitori

6、ng Procedures 監(jiān)測(cè)程序 The Required Records 要求的記錄 A Corrective Action 糾正措施 The Verification Procedures 驗(yàn)證程序,FDA水產(chǎn)品HACCP法規(guī),HACCP Plan - Hazards to be considered 要考慮到的危害: Natural Toxins 天然毒素 Microbiological 微生物 Chemical Pesticides 化學(xué)殺蟲劑 （農(nóng)藥） Drug Residues 藥物（獸藥）殘留 Unapproved Uses of Food and Color Additiv

7、es 未經(jīng)批準(zhǔn)使用的食品添加劑和色素 Physical Hazards 物理的危害 Decomposition Related to Safety 與安全有關(guān)的腐敗,FDA水產(chǎn)品HACCP法規(guī),HACCP Plan - Critical Control Points and Critical Limits: Critical Control Points 關(guān)鍵控制點(diǎn) - A point in processing where controls need to be in place Critical Limits 關(guān)鍵限值 - A limit expressed as a value (i.e

8、. time or temperature) listed at a critical control point.,FDA水產(chǎn)品HACCP法規(guī),Monitoring Procedures 監(jiān)測(cè)程序: What Will Be Monitored 監(jiān)測(cè)什么？ How Will Monitoring Be Done 怎樣監(jiān)測(cè)？ Frequency of Monitoring 監(jiān)測(cè)頻率、時(shí)間？ Who? 誰負(fù)責(zé)監(jiān)測(cè)？ Where? 在哪監(jiān)測(cè)？,FDA水產(chǎn)品HACCP法規(guī),Corrective Action - Predetermined 預(yù)先確定好的糾正措施: Corrective Action

9、Plans 糾正措施計(jì)劃,FDA水產(chǎn)品HACCP法規(guī),Verification 驗(yàn)證 - Reassessment 重新評(píng)估: Verify Plans No Less Than Once A Year 驗(yàn)證HACCP計(jì)劃每年至少一次,FDA水產(chǎn)品HACCP法規(guī),Verification - List Changes 以下改變必須驗(yàn)證: Raw Materials or Sources of Raw Materials 原料或原料來源 Product Formulation 產(chǎn)品配方 Processing Methods or Systems 加工方法或系統(tǒng) Finished Product

10、Distribution 成品的配發(fā) Intended Use of the Finished Product by Consumers 消費(fèi)者對(duì)成品預(yù)期用途,FDA水產(chǎn)品HACCP法規(guī),Verification - Verifying Performance 驗(yàn)證的措施: Consumer Complaints 消費(fèi)者投訴 Calibrating Instruments (i.e., thermometers) 校準(zhǔn)儀器 Testing 檢測(cè) Reviewing Records 審核記錄,FDA水產(chǎn)品HACCP法規(guī),Verification - Reassess Hazard Analysi

11、s 重新評(píng)估危害分析: Reassess Hazard Analysis - Whenever There Is a Change 一旦有改變，就必須重新進(jìn)行危害分析。,FDA水產(chǎn)品HACCP法規(guī),Records - Types 文件記錄的類型: HACCP Plan HACCP計(jì)劃 Monitoring Records 監(jiān)測(cè)記錄 Corrective Action Records 糾偏記錄 Verification Measures 驗(yàn)證記錄 Sanitation Records 衛(wèi)生方面的記錄 Importer Verification Records 進(jìn)口商驗(yàn)證記錄,FDA水產(chǎn)品HACC

12、P法規(guī),Records - Required Information 記錄的信息: Name and Location of Processor or Importer 加工者或進(jìn)口商的名稱和地點(diǎn) Date and Time of Activity Being Recorded 被記錄活動(dòng)的日期和時(shí)間 Signature or Initials of Person Making Record 記錄人員的簽名 Product Identity and Code (when appropriate) 產(chǎn)品名稱和代碼,FDA水產(chǎn)品HACCP法規(guī),Records - Retention 記錄保留的時(shí)間

13、: Refrigerated Products - 1 Year 冷藏產(chǎn)品 一年 Frozen Products - 2 Years 冷凍產(chǎn)品 二年,FDA水產(chǎn)品HACCP法規(guī),Records - Access: FDA Has Access to HACCP Records and Plans and may copy them (for domestic processors) FDA Has Access to Importer Records FDA有權(quán)檢查有關(guān)記錄，并進(jìn)行復(fù)印。,FDA水產(chǎn)品HACCP法規(guī),Plan Contents (復(fù)習(xí))HHACCP計(jì)劃的內(nèi)容包括： Hazard

14、s 危害 Critical Control Points 關(guān)鍵控制點(diǎn) Critical Limits 關(guān)鍵限值 Corrective Actions 糾正措施 Records 記錄 Verification 驗(yàn)證,FDA水產(chǎn)品HACCP法規(guī),Training - Options 培訓(xùn)方面的要求: Training in HACCP 參加相當(dāng)?shù)呐嘤?xùn) On-The Job Experience 有一定工作經(jīng)驗(yàn) “The Seafood HACCP Alliance” 美國(guó)水產(chǎn)品HACCP聯(lián)盟,FDA水產(chǎn)品HACCP法規(guī),Training - Choices: One Trained Employe

15、e 工作人員參加培訓(xùn) Trained Consultant 請(qǐng)培訓(xùn)過的專家顧問,FDA水產(chǎn)品HACCP法規(guī),Training - Individual Shall 下列工作必須要有一定資格的人員來進(jìn)行: Develop or Amend the HACCP Plan 制訂或修改HACCP計(jì)劃 Reassess and/or Modify the HACCP Plan 重新評(píng)估、修改HACCP計(jì)劃 Reassess and Modify the Hazard Analysis 重新評(píng)估和修改危害分析 Review All Records 審核所有的記錄,FDA水產(chǎn)品HACCP法規(guī),Sanitat

16、ion - Prerequisit HACCP的前提條件 :Prerequisite to HACCP Monitoring 監(jiān)測(cè) Records 記錄 Corrections 糾偏,FDA水產(chǎn)品HACCP法規(guī),Sanitation - 8 Areas :SSOP至少包括8個(gè)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 Contaminatio

17、n Exclusion of Pests Maintenance of Hand Washing, Hand Sanitizing and Toilet Facilities Protection From Contaminants Proper Labeling, Storage and Use of Toxic Compounds Control of Employee Health Conditions,FDA水產(chǎn)品HACCP法規(guī),Sanitation - Monitoring Frequency: Monitoring Frequencies 監(jiān)測(cè)頻率 Corrective Measu

18、res 糾正措施 Records 記錄,Records are required even if no HACCP plan is required 即使沒有HACCP計(jì)劃，仍然要求SSOP記錄,FDA水產(chǎn)品HACCP法規(guī),Sanitation - Handled Separately:,Sanitation controls can be included in the HACCP plan. 衛(wèi)生控制可包含再HACCP計(jì)劃中。,Sanitation controls can be handled outside of the HACCP plan. 衛(wèi)生控制可不包含在HACCP計(jì)劃里。,I

19、MPORTER REQUIREMENTS 對(duì)進(jìn)口商的要求,Coverage General Provisions 一般條款： All Processors 對(duì)所有加工者 Special Requirements for Importers 對(duì)進(jìn)口商 Special Provisions 特殊條款： Smoked Fish Raw Molluscan Shellfish,Definitions 定義 Importer 進(jìn)口商 - means either the U.S. owner or consignee at the time of entry into the United States

20、, or the U.W. agent or 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 123.12 Importer V

21、erification 進(jìn)口商驗(yàn)證 Import From Countries With An MOU 從與FDA簽署相應(yīng)MOU的國(guó)家進(jìn)口 Or或 Implement Verification Procedures 實(shí)施進(jìn)口商驗(yàn)證程序 -（可由有資格的第三方實(shí)施）,Written Verification Procedures 書面的驗(yàn)證程序 Product Specifications to ensure that the product is not injurious to health and not processed under insanitary conditions 產(chǎn)品說明

22、書 Affirmative Step 確認(rèn)步驟,HACCP REGULATION OVERVIEW IMPORTER REQUIREMENTS,Affirmative Step Requirement - Choose at least one: 任選其一 On-site visits by the importer 進(jìn)口商現(xiàn)場(chǎng)檢查 Obtaining the processors HACCP and sanitation records 得到加工者的HACCP計(jì)劃和衛(wèi)生方面的記錄 Obtaining the processors HACCP plan and guarantee 得到加工者的

23、HACCP計(jì)劃和保證書 End-product testing and guarantee 最終產(chǎn)品檢測(cè)和保證書 Obtaining a continuing or lot-by-lot certification 得到連續(xù)的或逐批的證書 （官方或第三方） Other verification methods其他驗(yàn)證方法,Aquaculture Processing 養(yǎng)殖過程中的藥物使用 Hazards associated with use of medications in feed or by direct administration,Office of Seafood,Aquacul

24、ture Processing Drugs used for: 藥物用于 Treating and preventing disease 治療和預(yù)防疾病 Controlling parasites 控制寄生蟲 Controlling reproduction 控制繁殖 Controlling growth 控制生長(zhǎng) Tranquilizing 鎮(zhèn)靜,Office of Seafood,Aquaculture Processing Conditions for drug approval: Species for which the drug is approved 用藥品種 Approved

25、dosage 劑量 Approved route of transmission 用藥途徑 Approved frequency of use 用藥頻率 Approved indications for use 癥狀,Office of Seafood,Aquaculture Processing Drugs approved by FDA: FDA批準(zhǔn)的藥物 Chorionic Gonadotropin Formalin solution Tricaine methanesulfonate Oxytetracycline Sulfamerazine Sulfadimethoxine/orme

26、toprim,Office of Seafood,Aquaculture Processing Labels of approved drugs list the mandatory withdrawal times, where applicable. 停藥期,Office of Seafood,Aquaculture Processing Tissue residue tolerances have been established for some drugs. 組織殘留限量,Office of Seafood,Molluscan Shellfish,Shellfish Authorit

27、y Government authority responsible for enforcement of all regulatory requirements associated with shellfish,Molluscan Shellfish,Shellfish defined as: Oysters Clams Mussels Scallops,Molluscan Shellfish,Regulatory requirements of the Shellfish Authority include: Growing area classification Harvesting

28、control Processing plant and procedure control Product labeling Storage, handling and packing Shipment control,Molluscan Shellfish,Hazards Associated With Shellfish: Pathogen microorganisms Natural Toxins from the harvest water Chemical contaminants from the harvest water,Molluscan Shellfish,Import

29、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 Shellfish,Import of Molluscan Shellfish Current MOU countries include: Ca

30、nada New Zealand Chile South Korea,Molluscan Shellfish,Control 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,

31、processing, labeling, and shipping of molluscan shellfish.,Molluscan Shellfish,Control 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

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

33、tries 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 Shellfish,Control of Natural Toxins Cooked molluscan shellfish is permitted to be imported into the United Sta

34、tes only if the processor has controlled the hazards associated with natural toxins from the harvest water.,Molluscan Shellfish,Control of Natural Toxins Cooking will not eliminate or significantly reduce the level of natural toxins in shellfish meats.,Molluscan Shellfish,Control of Natural Toxins 2

35、 methods of Control Monitoring of shellfish meats from “key” locations in the growing areas OR Monitoring of shellfish meats on a lot-by-lot basis at the processing facility.,Molluscan Shellfish,Control of Natural Toxins If natural toxins are controlled by monitoring shellfish at the growing area, t

36、he Control Authority must have authority to close the area from harvesting when unsafe levels are present in shellfish meats.,Molluscan Shellfish,Control of Natural Toxins There are four recognized shellfish poisoning syndromes resulting from natural toxins produced by marine algae.,Molluscan Shellf

37、ish,Control of Natural Toxins Paralytic Shellfish Poisoning (PSP) Neurotoxic Shellfish Poisoning (NSP) Diarrhetic Shellfish Poisoning (DSP) Amnesic Shellfish Poisoning (ASP),Molluscan Shellfish,Control of Natural Toxins Action Levels in Meats Paralytic Shellfish Poisoning - 0.8 PPM (80ug/100g) saxit

38、oxin equivalent.,Molluscan Shellfish,Control of Natural Toxins Action Levels in Meats Neurotoxic Shellfish Poisoning - 0.8 PPM (20 mouse units/100g) brevetoxin-2 equivalent.,Molluscan Shellfish,Control of Natural Toxins Action Levels in Meats Diarrhetic Shellfish Poisoning - 0.2 PPM okadaic acid plus 35-methyl okadaic acid.,Molluscan Shellfish,Control of Natural Toxins Action Level