Juice Imports: Affirmative Steps

January 22, 2004

Lists of Foreign Processors Approved by their Governments

FDA is providing, below, the website locations of lists provided by foreign government inspection authorities of processors of juice that, according to those authorities, are in good standing and are meeting the requirements of the FDA juice Hazard Analysis Critical Control Point (HACCP) regulation.

The regulation for the Safe and Sanitary Processing and Importing of Juice and Juice Products (21 CFR Part 120) requires that all juice in interstate commerce in the United States must have been processed in accordance with both the HACCP principles and the sanitation prerequisite requirements that are specified in the regulation. These requirements apply to imported as well as domestic products. Importers have a responsibility under the regulation to ensure that the juice they are importing meets those requirements.

There are essentially two ways in which importers may satisfy their regulatory obligations. First, they may obtain products from a country that has an active equivalence or compliance agreement with FDA covering juice. Under such an agreement, FDA has determined that government of the foreign country is operating a regulatory system for juice safety that ensures that the products being exported to the U.S. satisfy U.S. safety concerns.

Second, if no such agreement exists with the country of origin, importers must take their own "affirmative steps" to ensure that the products they are offering for entry have been processed under controls that meet the requirements of the regulation (21 CFR 120.14). FDA is inspecting importers to review the adequacy of these "affirmative steps."

The regulation does not mandate what affirmative steps importers must take, but gives examples of affirmative steps that importers may select. One of these examples include obtaining either a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or from a competent private party certifying that the products were produced in accordance with the U.S. requirements (21 CFR 120.14(a)(2)(ii)(B)).

The inspection authorities of some countries are issuing lists of processors that are in good standing with those authorities and are, according to the authorities, processing in accordance with the U.S. requirements. These lists, if regularly updated, may serve the same purpose as the issuance of "continuing" certificates by the foreign government inspection authority. Importers may consider purchasing from processors that are on such lists, and documenting that they are doing so, as one way of meeting their affirmative steps responsibility.

Importers should always consider, however, whether the steps they have chosen adequately ensure that the juice they receive has been processed in accordance with 21 CFR Part 120. Thus, importers should assess the credibility of the lists by considering factors such as those that will be considered by FDA (as discussed below) when doing so. In addition, importers should be aware that FDA has not verified the lists or the information on them. In considering whether to accept importation of products from processors on foreign government-supplied lists as satisfying the affirmative step obligation, FDA may consider such factors as the length of time since the foreign government inspection authority updated its list, the compliance history of the country and the individual foreign processor, and what is known generally about the regulatory structure of the foreign country.

The foreign countries and their websites are as follows:

China: Certification and Accreditation Administration of the People's Republic of China

Requests by foreign government inspection authorities for FDA to provide links to official website locations that lists processors that, according to those authorities, are in good standing and are meeting the requirements of FDAs Hazard Analysis Critical Control Point (HACCP) regulation should submitted to:

Dr. Robin Woo
International Affairs Staff
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835

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