[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR123.12]
[Page 281-282]
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 282]]
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.
Back to Top
© 2007 Betterchem Corp.
|
