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§ 123.12 Special requirements for imported products.
This section sets forth specific requirements for imported fish and fishery products.
（a） importer verification. Every importer of fish or fishery products shall either:
?。?） Obtain the fish or fishery product from a country that has an active memorandum of understanding （MOU） or similar agreement with the Food and Drug Administration, that covers the fish or fishery product and documents the equivalency or compliance of the inspection system of the foreign country with the U.S. system, accurately reflects the current situation between the signing parties, and is functioning and enforceable in its entirety; or
?。?） Have and implement written verification procedures for ensuring that the fish and fishery products that they offer for import into the United States were processed in accordance with the requirements of this part. The procedures shall list at a minimum:
?。╥） Product specifications that are designed to ensure that the product is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act because it may be injurious to health or have been processed under insanitary conditions, and,
（ii） Affirmative steps that may include any of the following:
?。ˋ） Obtaining from the foreign processor the HACCP and sanitation monitoring records required by this part that relate to the specific lot of fish or fishery products being offered for import;
（B） Obtaining either a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported fish or fishery product is or was processed in accordance with the requirements of this part;
?。–） Regularly inspecting the foreign processor's facilities to ensure that the imported fish or fishery product is being processed in accordance with the requirements of this part;
?。―） Maintaining on file a copy, in English, of the foreign processor's HACCP plan, and a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with the requirements of the part;
（E） Periodically testing the imported fish or fishery product, and maintaining on file a copy, in English, of a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with the requirements of this part or,
?。‵） Other such verification measures as appropriate that provide an equivalent level of assurance of compliance with the requirements of this part.
?。╞） Competent third party. An importer may hire a competent third party to assist with or perform any or all of the verification activities specified in paragraph （a）（2） of this section, including writing the importer's verification procedures on the importer's behalf.
?。╟） Records. The importer shall maintain records, in English, that document the performance and results of the affirmative steps specified in paragraph （a）（2）（ii） of this section. These records shall be subject to the applicable provisions of §123.9.
?。╠） Determination of compliance. There must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with this part. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under this part, the product will appear to be adulterated and will be denied entry.
§123.12對進口產品的特殊要求
（a）進口商驗證，每個進口商進口水產及其水產品須具備以下兩者之一：
?。?）進口的水產及水產品系來自與FDA簽有有效的諒解備忘錄（MOU）或類似協議的國家、協議涉及水產或水產品，并述明與美國體系等同或等效的外國檢驗體系，準確反映了各簽署方的現狀，并能全面有效的實施。
?。?）擁有并執行按本部分要求編寫的驗證程序，以確保進口到美國的水產及水產品按本部分的要求進行加工，程序中至少須列明以下內容：
?。╥）產品規格。由于可能有害健康或在不衛生條件下生產，產品規格可確保有關產品不是（聯
?。áⅲ┛梢园ǖ拇_證方法：
（A）擁有國外加工者提供的，本部分所要求的HACCP計劃和衛生監控記錄，這些計劃和記錄
要與每批進口水產及水產品相對應。
?。˙）擁有由相應的外國政府檢驗不當局或有資格的第三方簽發的連續或逐批的證書，證明進口的水產及水產品加工符合本部分的要求。
?。–）對國外加工者的設施進行常規檢查。以保證進口水產及水產品的加工符合本部分的要求。
?。―）保存一份國外加工都HACCP計劃的英文副本和一份書面擔保書，保證進口水產品的加工符合本部分的要求。
?。‥）定期對進口水產及水產品進行檢驗，并保存一份由國外加工者提供的英文書面擔保書副
本，保證進口水產及水產品的加工符合本部分要求；
?。‵）其他適當的驗證措施，可提供與本部分要求一致的同等水平的保證。
（b）有資格的第三方。
進口商可以雇傭有資格的第三方與之合作或執行本部分（a）段（2）所述的驗證活動，包括代表進口商制定驗證程序。
?。╟）記錄。
進口商必須保存記敘了執行本章（a）段（2）（ii）所述的確證步驟情況和執行結果的英文記錄，此類記錄要符合§123.9的有關要求。
（d）符合性的判定。所有允許進入美國的水產及水產品必須證實其加工符合本部分要求，如果不能保證水產及水產品系在本部分所要求的條件下加工，那么該產品將被視為偽劣食品，并禁止輸入本國。
更多有關美國FDA水產品HACCP法規內容，請點擊美國FDA水產品HACCP法規匯總。
