FDA Issues New Version of Compliance Policy Guide for Enforcing the Prior Notice Requirement for Imported Food ("Phase 4" of Enforcement Begins August 13 With Certain Delays, Leniencies)

(The FDA notes that the requirements for submitting PN to FDA were effective beginning December 12, 2003, and during the first eight months, FDA and CBP focused their resources on education to achieve compliance with the PN requirements. FDA adds that the agencies will continue their education and outreach efforts.)

New Enforcement Policy Provides for Certain Delays, Leniencies

FDA's August 2004 version of its Guide no longer presents three categories of violations, and no longer contains tables to indicate the date ranges and typical enforcement actions that FDA/CBP should consider during the four phases of its enforcement strategy (December 12, 2003 - March 12, 2004; March 13, 2004 - June 3, 2004; June 4, 2004 - August 12, 2004; and after August 12, 2004).

Instead, the August 2004 Guide discusses the typical enforcement actions FDA/CBP should consider after August 12, 2004, and delays enforcement for certain violations until November 1, 2004. In addition, certain of the typical enforcement actions listed below as effective after August 12, 2004 are more lenient that those that were listed in FDA's previous versions of the Guide for this same time period.

(FDA states that "the action FDA and CBP staff typically should consider taking," as used in the August 2004 Guide, means that FDA and CBP staff, exercising enforcement discretion, pursuant to their agencies policies and procedures, may take these actions or take different or additional actions if they believe particular circumstances warrant them.)

1. Shipments of food, other than food covered by numbers 2. - 5. below:

After August 12, 2004, for any PN violation, the action FDA and CBP staff typically should consider taking is refusal and/or assessment of CBP civil monetary penalties.

However, until November 1, 2004, the paragraph above does not apply to PN violations that are due to the fact that:

• the registration number submitted for the manufacturing facility is inaccurate or is invalid;
• the registration number for the shipper is not provided;
• the Airway Bill number or Bill of Lading number is not provided or is invalid; or
• the name and address of the ultimate consignee is inaccurate because it contains the name and address of the express consignment operator or consolidator instead of the ultimate consignee.

In these four situations, FDA and CBP should typically consider not taking any regulatory action. If however, the violation reflects a history of repeated conduct of a similar nature by a person who has been notified of such violations, then the action FDA and CBP staff typically should consider taking is assessment of CBP civil monetary penalties.

2. Food carried by or otherwise accompanying an individual:

After August 12, 2004, the action FDA and CBP staff typically should consider taking is education/communication for minor or inadvertent PN violations and refusal for all other PN violations. This applies to food carried by or otherwise accompanying an individual. PN is not required when an article of food is carried by or otherwise accompanying an individual and is for personal use.

However, until November 1, 2004, the paragraph above does not apply to PN violations that are due to the fact that:

• a registration number submitted for the manufacturing facility is inaccurate or invalid;
• the registration number for the shipper is not provided; or
• the name and address of the ultimate consignee is inaccurate because it contains the name and address of the express consignment operator or consolidator instead of the ultimate consignee.

In these three situations, FDA and CBP should typically consider not taking any regulatory action. If however, the violation reflects a history of repeated conduct of a similar nature by a person who has been notified of such violations, then the action FDA and CBP staff typically should consider taking is assessment of CBP civil monetary penalties.

3. Food arriving by international mail other than food imported or offered for import for non-commercial purposes with a non-commercial shipper:

After August 12, 2004, the action FDA and CBP staff typically should consider taking is education/communication for minor or inadvertent PN violations and refusal for all other PN violations. This applies to food arriving by international mail other than food imported or offered for import for non-commercial purposes with a non-commercial shipper.

However, until November 1, 2004, the paragraph above does not apply to PN violations that are due to the fact that:

• a registration number submitted for the manufacturing facility is inaccurate or invalid; or
• the registration number for the shipper is not provided.

In these two situations, FDA and CBP should typically consider not taking any regulatory action. If however, the violation reflects a history of repeated conduct of a similar nature by a person who has been notified of such violations, then the action FDA and CBP staff typically should consider taking is assessment of CBP civil monetary penalties.

4. Food imported or offered for import for non-commercial purposes with a non-commercial shipper, irrespective of the type of carrier:

FDA and CBP should typically consider not taking any regulatory action when an article of food is imported or offered for import for non-commercial purposes with a non-commercial shipper. 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. (Examples of such food, as well as an explanation regarding the shipper and carrier as different entities, are provided.)

5. Food imported or offered for import for quality assurance, research or analysis purposes only, not for human or animal consumption and not for resale:

If PN is inadequate because it doesn't include the registration number assigned to the manufacturing facility that is associated with the article of food, FDA and CBP should typically consider not taking any regulatory action if the article of food is imported or offered for import for quality assurance, research or analysis purposes only, not for human or animal consumption and not for resale. (Information regarding when samples of food are considered to be for quality assurance, etc. is provided.)

(See ITT's Online Archives or 12/12/03 news, 03121207 for BP summary of the December 2003 version of the Guide. See ITT's Online Archives or 12/15/03 news 03121505, for BP summary of FDA press release on the December 2003 Guide and PN Q&A. See ITT's Online Archives or 07/01/04 news, 04070110 for BP summary of the June 2004 version of the Guide.)

-written comments and suggestions may be submitted

FDA contact: Domenic Veneziano (703) 621-7809

FDA's August 2004 version of Compliance Policy Guide (posted 08/12/04), available at http://www.cfsan.fda.gov/pn/cpgpn3.html

(FDA's earlier June 2004 version of Compliance Policy Guide, available at http://www.cfsan.fda.gov/pn/cpgpn2.html )

BP Note

On August 12, 2004, FDA also posted three other documents regarding prior notice of imported foods, as follows:

Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes (revised August 2004), available at http://www.cfsan.fda.gov/pn/pnplan2.html

Prior Notice of Imported Food Contingency Plan for System Outages (dated August 12, 2004), available at http://www.cfsan.fda.gov/pn/pndguid.html

Compliance Summary Information: Prior Notice (revised August 2004), available at http://www.cfsan.fda.gov/pn/pnsum.html

See future issues of ITT for BP summaries of these three documents.