[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR123.12]

[Page 275-276]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 123_FISH AND FISHERY PRODUCTS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  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

[[Page 276]]

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 Sec.  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.