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itation controls can be included in the HACCP plan. 衛(wèi)生控制可包含再 HACCP計劃中。 Sanitation controls can be handled outside of the HACCP plan. 衛(wèi)生控制可不包含在 HACCP計劃里。 IMPORTER REQUIREMENTS 對進口商的要求 Coverage General Provisions 一般條款: ? All Processors 對所有加工者 ? Special Requirements for Importers 對進口商 Special Provisions 特殊條款: ? Smoked Fish ? Raw Molluscan Shellfish Definitions 定義 Importer 進口商 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 進口商驗證 ? Import From Countries With An MOU 從與 FDA簽署相應(yīng) MOU的國家進口 Or或 ? Implement Verification Procedures 實施進口商驗證程序 (可由有資格的第三方實施) Written Verification Procedures 書面的驗證程序 ? Product Specifications to ensure that the product is not injurious to health and not processed under insanitary conditions 產(chǎn)品說明書 ? Affirmative Step 確認步驟 HACCP REGULATION OVERVIEW IMPORTER REQUIREMENTS Affirmative Step Requirement Choose at least one: 任選其一 ? Onsite visits by the importer 進口商現(xiàn)場檢查 ? Obtaining the processor’s HACCP and sanitation records 得到加工者的 HACCP計劃和衛(wèi)生方面的記錄 ? Obtaining the processor’s HACCP plan and guarantee 得到加工者的 HACCP計劃和保證書 ? Endproduct testing and guarantee 最終產(chǎn)品檢測和保證書 ? Obtaining a continuing or lotbylot 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 Aquaculture 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 ? 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 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批準的藥物 ? 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 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