§123.12 对进口产品的特殊要求(Special requirements for imported products)

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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:

　　（1） 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

　　（2） 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:

　　（i） 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:

　　（A） 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;

　　（C） 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;

　　（D） 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,

　　（F） Other such verification measures as appropriate that provide an equivalent level of assurance of compliance with the requirements of this part.

　　（b） 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.

　　（c） 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.

　　（d） 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对进口产品的特殊要求

　　（a）进口商验证，每个进口商进口水产及其水产品须具备以下两者之一：

　　（1）进口的水产及水产品系来自与FDA签有有效的谅解备忘录（MOU）或类似协议的国家、协议涉及水产或水产品，并述明与美国体系等同或等效的外国检验体系，准确反映了各签署方的现状，并能全面有效的实施。

　　（2）拥有并执行按本部分要求编写的验证程序，以确保进口到美国的水产及水产品按本部分的要求进行加工，程序中至少须列明以下内容：

　　（i）产品规格。由于可能有害健康或在不卫生条件下生产，产品规格可确保有关产品不是（联

　　（ⅱ）可以包括的确证方法：

　　（A）拥有国外加工者提供的，本部分所要求的HACCP计划和卫生监控记录，这些计划和记录

　　要与每批进口水产及水产品相对应。

　　（B）拥有由相应的外国政府检验不当局或有资格的第三方签发的连续或逐批的证书，证明进口的水产及水产品加工符合本部分的要求。

　　（C）对国外加工者的设施进行常规检查。以保证进口水产及水产品的加工符合本部分的要求。

　　（D）保存一份国外加工都HACCP计划的英文副本和一份书面担保书，保证进口水产品的加工符合本部分的要求。

　　（E）定期对进口水产及水产品进行检验，并保存一份由国外加工者提供的英文书面担保书副

　　本，保证进口水产及水产品的加工符合本部分要求；

　　（F）其他适当的验证措施，可提供与本部分要求一致的同等水平的保证。

　　（b）有资格的第三方。

　　进口商可以雇佣有资格的第三方与之合作或执行本部分（a）段（2）所述的验证活动，包括代表进口商制定验证程序。

　　（c）记录。

　　进口商必须保存记叙了执行本章（a）段（2）（ii）所述的确证步骤情况和执行结果的英文记录，此类记录要符合§123.9的有关要求。

　　（d）符合性的判定。所有允许进入美国的水产及水产品必须证实其加工符合本部分要求，如果不能保证水产及水产品系在本部分所要求的条件下加工，那么该产品将被视为伪劣食品，并禁止输入本国。

　　更多有关美国FDA水产品HACCP法规内容，请点击美国FDA水产品HACCP法规汇总。