21 CFR 120.14 - Application of requirements to imported products.
This section sets forth specific requirements for imported juice.
(1) Obtain the juice from a country that has an active memorandum of understanding (MOU) or similar agreement with the Food and Drug Administration, that covers the food and documents the equivalency or compliance of the inspection system of the foreign country with the U.S. system, accurately reflects the relationship between the signing parties, and is functioning and enforceable in its entirety; or
(2) Have and implement written procedures for ensuring that the juice that such importer receives for import into the United States was processed in accordance with the requirements of this part. The procedures shall provide, at a minimum:
(i) Product specifications that are designed to ensure that the juice is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act because it may be injurious to health or because it may have been processed under insanitary conditions; and
(ii) Affirmative steps to ensure that the products being offered for entry were processed under controls that meet the requirements of this part. These steps may include any of the following:
(A) Obtaining from the foreign processor the Hazard Analysis and Critical Control Point (HACCP) plan and prerequisite program of the standard operating procedure records required by this part that relate to the specific lot of food being offered for import;
(B) Obtaining either a continuing or lot specific certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported food has been processed in accordance with the requirements of this part;
(D) Maintaining on file a copy, in English, of the foreign processor's hazard analysis and HACCP plan, and a written guarantee from the foreign processor that the imported food is processed in accordance with the requirements of this part;
(E) Periodically testing the imported food, and maintaining on file a copy, in English, of a written guarantee from the foreign processor that the imported food is processed in accordance with the requirements of this part; or
(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 § 120.12.
(d)Determination of compliance. The importer shall provide evidence that all juice offered for entry into the United States has been processed under conditions that comply with this part. If assurances do not exist that an imported juice 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.