fda水产品haccp法规ppt75中英文-法律法规(编辑修改稿)

fda水产品haccp法规ppt75中英文-法律法规(编辑修改稿)内容摘要：

itation 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 pliance 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 • Onsite 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 • Endproduct testing and guarantee 最终产品检测和保证书 • Obtaining a continuing or lotbylot 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 microanisms • Natural Toxins from the harvest water • Chemical contaminants from the。