June 1, 2009

The Food and Drug Administration (FDA) recently issued a revised Compliance Policy Guide (CPG) on its enforcement of the requirements for submitting prior notice (PN) for food imported or offered for import into the United States (21 C.F.R. §§ 1.276-1.285). Prior notice of imported food is required pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The FDA's final rule regarding prior notice went into effect on May 6, 2009.



Although the CPG does not establish legally enforceable responsibilities or bind the FDA or the public, it serves as a description of the FDA's current thinking on the prior notice requirement. The purpose of the CPG is to provide guidance to FDA and U.S. Customs and Border Protection (CBP) staff on enforcing the final rule, which requires the submission of PN to FDA electronically via CBP's automated system(s) or FDA's Prior Notice System Interface (PNSI). Food imported or offered for import without adequate PN is subject to refusal.



According to the FDA, the new CPG supersedes previously issued versions of the guide. There are numerous changes to the CPG. For example, the May 2009 guide adds new areas of enforcement discretion for foreign-to-foreign mail and courier shipments, U.S. federal government shipments, and seeds imported for cultivation. It also eliminates enforcement discretion if an alternative facility is provided when the actual manufacturer and registration number are not known. Now a site-specific manufacturer registration number or full address must be provided.



In addition, certain provisions on the submission of PN and express carrier tracking numbers appear in the final rule instead of the CPG. Under the final rule, the PN submission may be submitted no more than 15 days prior to arrival for PNSI and no more than 30 days prior to arrival for ABI/ACS. In addition, in some instances, the express consignment operator or carrier tracking number may be submitted in lieu of (1) anticipated arrival information, (2) the bill of lading or airway bill number, or (3) the flight number.



The following is a partial list of items to which the PN requirements do not apply:

• "personal use" food brought by travelers;


• home-made food sent by the individual who made it as a personal gift;


• food that is imported then exported without leaving the port of arrival until export;


• meat, poultry or egg products under exclusive USDA jurisdiction at the time of importation; and


• food shipped as baggage or cargo constituting the diplomatic pouch.
  
  

The following section, excerpted from the CPG, provides guidance to FDA and CBP staff when they encounter the situations described below. FDA and CBP staff may take different or additional actions if they believe particular circumstances warrant them.



Regulatory action should not be considered by FDA and CBP when there is no prior notice in the following scenarios, or for certain gift packs, when the PN identifies the packer rather than the manufacturer(s):

• Non-commercial imports by non-commercial shippers, irrespective of the type of carrier, including food in household goods, including military and civilian transfers; food purchased and shipped home by U.S.-based travelers (and not by a commercial establishment); and gifts purchased at commercial establishments but shipped by the purchaser, not the establishment;


• Imports for quality assurance, research or analysis purposes only, not for human or animal consumption or resale, in quantities consistent with such ends, but not including samples for test marketing, such as tasting at trade-shows or product promotional tasting events;


• Imports for "in vivo" testing in non-food producing laboratory animals;


• Foreign-to-foreign mail when the article is not consigned for delivery to a U.S. party/address;


• Courier shipments when the carrier is an express consignment operator or carrier and the importer, owner, or recipient/consignee is not located in the United States;


• Official U.S. federal government shipments, provided that a Federal Government agency is the importer of record;


• Imported food arriving from and exiting to the same country, if certain conditions are met;


• Seed imported or offered for import for cultivation, generally when no more than a small portion of the seed is likely to be diverted from cultivation to animal feed or other food use.


• Gift packs imported by individuals for non-business purposes (not for sale or commercial use), for which a single prior notice is filed with the identity of the facility that packed the gift pack, rather than the identity of all the manufacturers of each article of food in the gift pack.
  
  

The following are acceptable reasons for not providing a manufacturers' registration number:

• facility out of business;


• private residences;


• restaurants exempted under 21 CFR 1.226(d);


• retail food establishments exempted under 21 CFR 1.226(c);


• non-processing fishing vessels exempted under 21 CFR 1.226(f);


• non-bottled drinking water establishments per 21 CFR 1.227(b)(2);


• farms exempted under 21 CFR 1.226(b);


• the submitter is unable to determine the registration number, but submits the full address.
  
  

FDA intends to reject prior notice submissions unless the prior notice includes a valid registration number or an appropriate reason selected from among those listed above. The requirement that FDA provide confirmation of receipt of Prior Notice does not apply to rejected submissions.



FDA staff should verify the validity of any circumstance where a reason is provided in lieu of a registration number.



If the reason provided is that the submitter is unable to determine the registration number of the manufacturer, FDA should nonetheless verify the identity of the manufacturing facility and its registration status. Without the registration number, it will be more difficult and/or may take more time for FDA to verify the identity of the manufacturing facility and its registration status and to determine whether the article of food is subject to being held under section 801(l) of the act. As a result, if an article of food is imported or offered for import and the registration number is not provided, and if FDA has concerns that the food may pose a serious health threat, then physical movement of the food shipment beyond the arrival port may be delayed until the verification is completed.



If the registration number of the facility that manufactured the food is not submitted as part of prior notice, FDA may also consider this in determining whether and where to examine the article of food.



FDA and CBP's enforcement strategy for violations is to take into account the severity of the violations, whether they are flagrant, and whether the person has had previous violations, particularly if they were similar types of violations.



When it is consistent with FDA's public protection responsibilities and depending on the nature of the violation, individuals and firms may be given an opportunity to take voluntary and prompt corrective action before the agency initiates enforcement actions. For instance, FDA may elect to refuse PNs, or may send Compliance letters to give warning to the responsible parties, prior to pursuing other regulatory actions.



The regulatory actions for violations include:

• Refusal for no prior notice, inaccurate prior notice, or untimely prior notice;


• Hold on importing, or offering for import, food from a foreign facility that is not registered;


• Injunction;


• Prosecution;


• Debarment;


• CBP seizure and assessment of civil monetary penalties for violations of any laws enforced by CBP, including but not limited to 19 USC 1595a. Civil monetary penalties may be assessed against any person who directs, assists, financially or otherwise, or is in any way concerned in the importation of any merchandise contrary to law.
  
  

For more information on FDA's announcement in the Federal Register regarding the revised CPG, please access the following site: http://edocket.access.gpo.gov/2009/pdf/E9-10556.pdf



The FDA Compliance Policy Guide, entitled "Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (dated May 2009) is available at http://www.cfsan.fda.gov/~pn/cpgpn8.html