[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.14]

[Page 267-268]
 
                        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 Contents
 
                      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 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

[[Page 268]]

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.