FDA Issues New Version of Compliance Policy Guide for Enforcing the Prior Notice Requirement for Imported Food
The Food and Drug Administration (FDA) has issued a November 2004 version of its Compliance Policy Guide (Guide) on the FDA and U.S. Customs and Border Protection (CBP) strategy for enforcing the requirements of the interim final rule for submitting prior notice (PN) for imported food.
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
Phase 5 of PN Program Scheduled to Go into Effect on November 8, 2004
FDA sources state that Phase 5 of its enforcement strategy for PN for imported food is now scheduled to go into effect on November 8, 2004 (from November 1, 2004), but this date could be pushed back if necessary. (See today's ITT, 04110420 and 04110415, for BP summaries of OASIS/PNSI scheduled downtime and PNSI Version 1.5.)
Highlights of the FDA's November 2004 Version of its Compliance Policy Guide
With respect to the revised Guide, the Introduction, Background, and Sections A (types of violations) and B (actions in response to violations) of the Regulatory Action Guidance heading remain largely unchanged. However, the FDA has substantially revised Section C (Policy) under the Regulatory Action Guidance.
In addition, an Appendix (Reason codes for registration number of manufacturer not provided) has been added to this revised Guide. These changes are highlighted below (see Guide for full details):
Policy. The revisions to Section C of the Guide, which sets forth guidance for FDA and CBP staff when they encounter certain PN situations, are as follows (partial list):
Requirements for identity of the manufacturer. The FDA has added a new table (Table 1) which lists four situations (when manufacturer is required to be registered; when manufacturer is not required to be registered; articles for transshipment, storage and export, or further manipulation and export; and personal gifts) and the PN information (name, registration number, street address, etc.) that must be provided in each of the four circumstances.
Enforcement discretion for good faith efforts to find identity of the manufacturer. The FDA has also added a second table (Table 2) on enforcement discretion that describes what the person submitting PN should provide if, after a good faith effort, that person does not know: (i) the registration number of a manufacturing facility that is required to be registered, (ii) either the registration number or the name and full address of the facility that manufactured the food, (iii) etc. The person submitting PN should also list the reason code (A-O) that identifies the situation for which the registration number of the manufacturer is not provided (see below).
Actions FDA and CBP staff should consider taking for PN violations. The FDA's Guide has also been revised with respect to the general guidelines on the actions FDA and CBP staff typically should consider taking for PN violations in the following situations:
Shipments of food (other than food covered by another section of the Guide). The Guide discuses regulatory actions that FDA and CBP should typically consider taking for PN violations for:
o identity of the manufacturer violations,
o inadequate PN from express couriers, or
o PN timeframe violations (e.g., submissions more than 5 days in the future);
Food carried by/ otherwise accompanying an individual that is not for personal use;
Food imported or offered for import for non-commercial purposes with a non-commercial shipper, irrespective of the type of the carrier;
Food arriving by international mail that is notfood imported or offered for import for non-commercial purposes with a non-commercial shipper;
Gift pack purchased or otherwise acquired by an individual and imported or offered for import for non-business purposes; and
Food imported or offered for import or quality assurance, research or analysis purposes only, not for human or animal consumption or resale.
Appendix 1 (Reason Codes). The FDA has also revised its Guide by adding "Appendix 1" which contains reason codes (A-O) for situations when the registration number of the manufacturer is not provided. Examples of these reasons include facility is out of business, facility is a private residence, etc.
(See ITT's Online Archives or 08/13/04 news, 04081305, for BP summary of the August 2004 version of this Guide.)
FDA's Guide (revised November 2004) available atwww.cfsan.fda.gov/pn/cpgpn4.html