FDA水产品HACCP法规分析

1、1会计学FDA水产品水产品HACCP法规分析法规分析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 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Sanitation controls can

2、 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 对所有加工者 Special Requirements for Importers 对进口商Special Provisions

3、 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 of entry in the United States, who is responsible for ensu

4、ring 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 Implement Verification Procedures 实施进口商验证程序 -（可由有资格的第三方实施）Written

5、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 REQUIREMENTSAffirmative Step Requirement - Choose at least one: 任选其一任选其一 On-s

6、ite 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 continuing or lot-by-lot certification 得到连续的或逐批的证书 （官方或第三方） Othe

7、r 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 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 Contro

8、lling 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 transmission 用药途径用药途径 Approved frequency of use 用药频率用药频率 Approved ind

9、ications 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 SeafoodAquaculture ProcessingLabels of approved drugs list the manda

10、tory 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 SeafoodShellfish AuthorityGovernment authority responsible for enforcement of all regulatory requirements associated with shell

11、fishShellfish defined as: Oysters Clams Mussels ScallopsRegulatory requirements of the Shellfish Authority include: Growing area classification Harvesting control Processing plant and procedure control Product labeling Storage, handling and packing Shipment controlHazards Associated With Shellfish:

12、Pathogen microorganisms Natural Toxins from the harvest water Chemical contaminants from the harvest waterImport 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

13、Food and Drug Administration.Import of Molluscan Shellfish Current MOU countries include: Canada New Zealand Chile South Korea 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

14、implementation of NSSP requirements to control the growing, harvesting, processing, labeling, and shipping of 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 o

15、f raw molluscan shellfish, the control strategy for pathogenic microorganisms will be adequate cooking.Control of Pathogenic Microorganisms in Shellfish from Non-MOU Countries Cooking or pasteurization process must reduce the target organism to a non-detectable level. Control of Pathogenic Microorga

16、nisms Countries 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. Control of Natural Toxins Cooked molluscan shellfish is permitted to be imported into the United States only i

17、f the processor has controlled the hazards associated with natural toxins from the harvest water.Control of Natural Toxins Cooking will not eliminate or significantly reduce the level of natural toxins in shellfish meats. Control of Natural Toxins 2 methods of Control Monitoring of shellfish meats f

18、rom “key” locations in the growing areasOR Monitoring of shellfish meats on a lot-by-lot basis at the processing facility.Control of Natural Toxins If natural toxins are controlled by monitoring shellfish at the growing area, the Control Authority must have authority to close the area from harvestin

19、g when unsafe levels are present in shellfish meats. Control of Natural Toxins There are four recognized shellfish poisoning syndromes resulting from natural toxins produced by marine algae. Control of Natural Toxins Paralytic Shellfish Poisoning (PSP) Neurotoxic Shellfish Poisoning (NSP) Diarrhetic

20、 Shellfish Poisoning (DSP) Amnesic Shellfish Poisoning (ASP)Control of Natural Toxins Action Levels in Meats Paralytic Shellfish Poisoning - 0.8 PPM (80ug/100g) saxitoxin equivalent.Control of Natural Toxins Action Levels in Meats Neurotoxic Shellfish Poisoning - 0.8 PPM (20 mouse units/100g) brevet

21、oxin-2 equivalent. Control of Natural Toxins Action Levels in Meats Diarrhetic Shellfish Poisoning - 0.2 PPM okadaic acid plus 35-methyl okadaic acid. Control of Natural Toxins Action Levels in Meats Amnesic Shellfish Poisoning - 20 PPM domoic acid. Control of Natural Toxins Southern China - At risk

22、 for Paralytic Shellfish Poisoning Northern China - At risk for Diarrhetic Shellfish PoisoningControl of ChemicalsCooked molluscan shellfish is permitted to be imported into the United States only if the processor has controlled the hazards associated with environmental chemical contaminants.Control

23、 of Chemicals2 methods 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.Control of ChemicalsIf chemical contaminants are controlled by monitoring shellfish at the growing area, the Cont

24、rol Authority must have authority to close the area from harvesting when unsafe levels are present in shellfish meats.Control 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.Millie Benjamin at the U.S. Food and Drug Administratione-mail: MBAquaculture 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