FDA水产品HACCP 法规
- 21 CFR 123, 1240
FDA水产品HACCP 法规
Subpart A
Definitions 定义
Good Manufacturing Practices （GMP）
Hazard Analysis & Hazard Analysis Critical Control Point plan （HACCP计划）
Corrective Actions 纠正措施
Verification 验证
Records 记录
Training 培训
Sanitation 卫生 （SSOP）
Requirements of Imported Products 对进口产品的要求
FDA水产品HACCP法规
Subpart B - Smoked Fish 烟熏鱼
FDA水产品HACCP 法规
Subpart C - Raw Molluscan Shellfish
生的软体贝类
FDA水产品HACCP法规
HACCP 只适用于 :
食品安全的危害
FDA水产品HACCP法规
Subpart A 适用于所有加工者
FDA水产品HACCP法规
不受法规制约的设施:
Fishing Vessels 捕捞船
Transportation Vehicles 运输工具
Retail Establishments, Including Restaurants
包括餐馆在内的零售设施
FDA水产品HACCP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HACCP法规
Definitions:
Fish 水产 - all forms of aquatic animal life intended for human consumption; including amphibians, mollusks, and roe.
FDA水产品HACCP法规
Definitions:
Fishery Products 水产制品 - any human food product in which fish is the characterizing ingredient.
FDA水产品HACCP法规
Good Manufacturing Practices (GMP’s)
Ties GMP’s HACCP regulations
FDA水产品HACCP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 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HACCP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, microbiological and/or chemical 物理、化学与生物危害
FDA水产品HACCP法规
Hazard must be one that is reasonably likely to occur
极可能发生的危害
FDA水产品HACCP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HACCP计划
FDA水产品HACCP法规
The HACCP Plan
Each Location
Each Product
HACCP计划是针对于每一个加工地点、每一种产品
FDA水产品HACCP法规
HACCP计划必须包括 :
The Food Safety Hazard 食品安全危害
The Critical Control Points of Each Hazard 每一个危害的关键控制点
The Critical Limits 关键限值
The Monitoring Procedures 监测程序
The Required Records 要求的记录
A Corrective Action 纠正措施
The Verification Procedures 验证程序
FDA水产品HACCP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
Physical Hazards 物理的危害
Decomposition Related to Safety 与安全有关的腐败
FDA水产品HACCP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 (. time or temperature) listed at a critical control point.
FDA水产品HACCP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HACCP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HACCP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HACCP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 Use of the Finished Product by Consumers 消费者对成品预期用途
FDA水产品HACCP法规
Verification - Verifying Performance
验证的措施:
Consumer Complaints 消费者投诉
Calibrating Instruments (., thermometers) 校准仪器
Testing 检测
Reviewing Records 审核记录
FDA水产品HACCP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HACCP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HACCP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 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HACCP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HACCP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HACCP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HACCP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HACCP联盟
FDA水产品HACCP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HACCP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HACCP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HACCP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 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 Labeling, Storage and Use of Toxic Compounds
Control of Employee Health Conditions
FDA水产品HACCP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HACCP计划，仍然要求SSOP记录
FDA水产品HACCP法规
Sanitation - Handled Separately:
Sanitation controls can be included in the HACCP plan.
卫生控制可包含再HACCP计划中。
Sanitation controls can be handled outside of the HACCP plan.
卫生控制可不包含在HACCP计划里。
IMPORTER REQUIREMENTS
对进口商的要求
Coverage
General 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
Importer 进口商 - means either the . owner or consignee at the time of entry into the United States, or the . 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
Importer Verification 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 Verification Procedures
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 OVERVIEW
IMPORTER REQUIREMENTS
Affirmative Step Requirement - Choose at least one: 任选其一
On-site visits by the importer 进口商现场检查
Obtaining the processor’s HACCP and sanitation records 得到加工者的HACCP计划和卫生方面的记录
Obtaining the processor’s 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）
Other verification methods其他验证方法
Aquaculture Processing
养殖过程中的药物使用
Hazards associated with use of medications in feed or by direct administration
Office of Seafood
Aquaculture Processing
Drugs used for: 药物用于
Treating and preventing disease 治疗和预防疾病
Controlling parasites 控制寄生虫
Controlling reproduction 控制繁殖
Controlling growth 控制生长
Tranquilizing 镇静
Office of Seafood
Aquaculture Processing
Conditions for drug approval:
Species for which the drug is approved 用药品种
Approved dosage 剂量
Approved route of transmission 用药途径
Approved frequency of use 用药频率
Approved indications for use 症状
Office of Seafood
Aquaculture Processing
Drugs approved by FDA:
FDA批准的药物
Chorionic Gonadotropin
Formalin solution
Tricaine methanesulfonate
Oxytetracycline
Sulfamerazine
Sulfadimethoxine/ormetoprim
Office of Seafood
Aquaculture Processing
Labels of approved drugs list the mandatory withdrawal times, where applicable.
停药期
Office of Seafood
Aquaculture Processing
Tissue residue tolerances have been established for some drugs.
组织残留限量
Office of Seafood
Molluscan Shellfish
Shellfish Authority
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 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 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:
Canada
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, 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 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
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.
Molluscan Shellfish
Control of Natural Toxins
Cooked molluscan shellfish is permitted to be imported into the United States 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 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, the 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 Shellfish
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 - PPM (80ug/100g) saxitoxin equivalent.
Molluscan Shellfish
Control of Natural Toxins
Action Levels in Meats
Neurotoxic Shellfish Poisoning - PPM (20 mouse units/100g) brevetoxin-2 equivalent.
Molluscan Shellfish
Control of Natural Toxins
Action Levels in Meats
Diarrhetic Shellfish Poisoning - PPM okadaic acid plus 35-methyl okadaic acid.
Molluscan Shellfish
Control of Natural Toxins
Action Levels in Meats
Amnesic Shellfish Poisoning - 20 PPM domoic acid.
Molluscan Shellfish
Control of Natural Toxins
Southern China - At risk for Paralytic Shellfish Poisoning
Northern China - At risk for Diarrhetic Shellfish Poisoning
Molluscan Shellfish
Control of Chemicals
Cooked 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 Shellfish
Control of Chemicals
2 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 Chemicals
If 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 Shellfish
Control of Chemicals
Guidance Levels in Mollusks
Refer to Table #9-1, Chapter 9 of FDA’s Fish and Fisheries Products Hazards & Guide for tolerances and action levels for additional environmental chemical contaminates.
For Additional Information
contact:
Millie Benjamin at the . Food and Drug Administration
e-mail: MBenjam1@
Shellfish are considered a high risk food because they are commonly eaten raw. In addition, they are filter feeders, not moving far, or at all, from where they originally begin their lives. Consequently, their safety is dependent on the quality and safety of the water where they have been grown and harvested.
As a result, FDA expects countries that offer shellfish for export to have a government regulatory authority responsible for shellfish and who will ensure full compliance with the the United States National Shellfish Sanitation Program (NSSP). The Shellfish Authority in a country is the government regulatory authority with the most knowledge and experience in shellfish growing and harvesting. The Shellfish Authority is responsible for the safety of shellfish offered for sale or export in their country.
Scallops are included only when the final product is whole or when the roe is still attached. They are excluded when the final product is the adductor muscle.
The Shellfish Authority is expected to control each of the items listed above. They must be able to identify and control a safety problem at any one of these points prior to sale, and to have the authority to prevent unsafe product from reaching the marketplace.
HACCP identifies the above three hazards for shellfish. The NSSP specifically calls for control of these hazards as well.
FDA has a Memorandum of Understanding with only a few countries for the importation of raw molluscan shellfish. The MOU is a signed agreement by the participating country to control the safety of molluscan shellfish in accordance with the NSSP. Only countries that have a current Memorandum of Understanding with FDA are permitted to import their “raw” shellfish into the United States.
FDA has Memorandums of Understanding for the importation of “raw” molluscan shellfish with these four countries.
In MOU countries, the hazard of pathogenic microorganisms is controlled through implementation of NSSP requirements. The NSSP requires that shellfish be grown in clean waters, harvested only from clean waters, processed in a safe and sanitary manner, properly labeled, and shipped in a safe and sanitary manner.
Non-MOU countries may only import “cooked” molluscan shellfish into the United States.
The cooking process must be adequate to reduce microorganisms to a non-detectable level.
FDA has zero tolerance for Salmonella spp. and Listeria monocytogenes in cooked ready-to-eat products.
Certain species of marine plankton can produce natural toxins. These toxins, which do not harm shellfish, can be concentrated in shellfish and cause serious illness or death if the shellfish are eaten.
The following are FDA’s Action Levels for natural toxins. They can be found in the Fish and Fisheries Products Hazards & Controls Guide, Chapter 6 - Natural Toxins.
FDA has found from information collected during many visits to China that Southern China is at risk for Paralytic Shellfish Poisoning and Northern China is at risk for Diarrhetic Shellfish Poisoning.
Environmental chemical contaminants include heavy metals and peticides. These are often associated with pollution from land based activities such as agricultural and industrial processing.
Table 9-1 lists all chemical contaminants for which FDA has tolerance or action establishes. It also lists FDA guidance levels for five additional contaminants.
