FDA Issues Revised Compliance Policy Guide for Enforcing the Prior Notice Requirement for Imported Food
The Food and Drug Administration (FDA) has issued a June 2004 version of its Compliance Policy Guide (Guide) on the FDA and U.S. Customs and Border Protection (CBP's) strategy for enforcing the requirements of the interim final rule for submitting prior notice (PN) for imported food.
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(The FDA's Guide notes that the enforcement phase-in period, which began on December 12, 2003, the FDA and CBP plan to mostly focus their resources on education to achieve compliance with the PN requirements. Most recently, Phase 3 of the phase-in period began on June 4, 2004 and will run through August 12, 2004.)
Highlights of Changes to FDA's PN Compliance Policy Guide
In addition to certain editorial changes, the revised version of the FDA's Guide contains the following additions and changes (partial list):
Food imported for non-commercial purposes with a non-commercial shipper. The FDA has added an additional table (Table 4) and explanatory text to its Guide concerning cases in which food is imported or offered for import for non-commercial purposes with a non-commercial shipper, irrespective of the type of carrier. FDA explains that generally, staff should consider a non-commercial purpose to be when the food is purchased or otherwise acquired by an individual for non-business purposes and the shipper is an individual (e.g. the individual delivers the food to a post office or common carrier for delivery to self, family member, or friend for non-business purposes (i.e., not for sale, resale, barter, business use, or commercial use).
FDA states that such food may arrive by international mail or other mode of transportation, but must be shipped by one individual to another individual (self, family member, or friend) to be considered for non-commercial purposes. Examples of food covered by this non-commercial category are:
Food in household goods, including military, civilian, governmental agency, and diplomatic transfers;
Food purchased by a traveler and mailed or shipped to the traveler's U.S. address by the traveler; and
Gifts purchased at a commercial establishment and shipped by the purchaser, not the commercial establishment.
According to Table 4, after June 24, 2004, if PN is not submitted for such non-commercial shipments, FDA and CBP staff should typically consider the following: (1) refusal for Category 1 violations (credible information of threat of serious adverse health results); (2) education and communication for Category 2 violations (history of violative conduct of a similar nature by a person so notified, or apparent intentional or flagrant violations; (3) no action for Category 3 violations (all violations other than those of Category 1 or 2).
In addition, the revised Guide states that education and communication for such violations could entail providing an information sheet on PN to the importer, owner, consignee, or shipper.
However, the FDA's notice states that with respect to these food imports, FDA intends to focus its efforts on education through March 2005 (or shortly thereafter, depending on the date of issuance of the final rule).
Diplomatic bags and pouches excluded from PN requirements. The FDA has added a seventh exception to the PN requirements which states that PN is not required under FDA requirements for food brought into the U.S. in a diplomatic pouch. FDA explains that any baggage or cargo marked "diplomatic bag" or "diplomatic pouch" is immune from search, including by electronic devices, and thus its contents are not subject to FDA's PN requirements.
Additional violation type added. In its Guide, FDA lists types of PN violations. Under the heading "No PN Confirmation" it has added a third violation. This violation pertains to instances when the PN Confirmation Number for an article of food for which PN was submitted through the FDA's PN System Interface (PNSI) is not provided to CBP or FDA upon arrival.
Phase-in dates updated. Table 1 in the revised Guide contains dates for the phase-in periods which reflect Phase 3's delayed June 4, 2004 implementation date (rather than the originally scheduled May 13, 2004 implementation date). Phase 3 is now listed as running from June 4, 2004 to August 12, 2004. Likewise, Phase 2 is shown as running from March 13, 2004 to June 3, 2004 to reflect the delay. (See ITT's Online Archives or 06/03/04 news, 04060305, for BP summary of Phase 3's June 4, 2004 implementation.)
(See ITT's Online Archives or 05/14/04, 12/15/03, and 12/12/03 news, 040514100312150503121207, for BP summaries of the original version of the FDA's Guide.)
-written or electronic comments may be submitted to the FDA on this Guide
FDA Contact - Domenic Veneziano (703) 621-7809
FDA's notice announcing availability of its revised Guide (D/N No. 2003D-0554, FR Pub 06/29/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-14766.pdf
FDA's Compliance Policy Guide (revised June 2004) available at http://www.cfsan.fda.gov/pn/cpgpn2.html