[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: 21CFR120.14]
[Page 272-273]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of
Subpart A General Provisions
Sec. 120.14 Application of requirements to imported products.
This section sets forth specific requirements for imported juice.
(a) Importer requirements. Every importer of juice shall either:
(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
[[Page 273]]
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;
(C) Regularly inspecting the foreign processor's facilities to
ensure that the imported food is being 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
(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 Sec. 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.
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