April 28, 2009
On November 7, 2008, the U.S. Food and Drug Administration (FDA) and the U.S. Customs and Border Protection (CBP) published the "Prior Notice of Imported Food Final Rule" and a draft compliance policy guide (CPG) that outlines the agencies' enforcement policies regarding the final rule (73 Federal Register 66294 (final rule) and 73 Federal Register 66411 (CPG)). The final rule amended the existing Prior Notice Interim Final Rule (PN IFR) contained in 21 CFR Part 1, Subpart I, which has been in effect since December 12, 2003; the final rule takes effect on May 6, 2009. Also on May 6, 2009, FDA and CBP intend to announce the availability of the final CPG, which describes FDA and CBP's strategy for enforcing the requirements of the prior notice final rule while maintaining an uninterrupted flow of food imports.
The prior notice final rule implements section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (21 U.S.C. 381), which requires that FDA receive prior notice of food imported into the United States. The final rule revises the IFR in only a few key areas, which were summarized in a Constituent Update of October 31, 2008
Beginning on May 6, 2009, FDA's Prior Notice System Interface (PNSI) may be used to file prior notices that account for and reflect requirement changes in the final rule. However, all CBP Automated Commercial System (ACS) and Automated Commercial Environment (ACE) programming changes will not be in place by May 6, 2009. As a result, import filers who file through the Automated Broker Interface (ABI) should be familiar with the final rule changes since they will need to adjust or retain their prior notice submissions in ABI/ACS as noted in the bulleted items below. Please note, however, that prior notices filed through ABI/ACS will be transmitted to FDA for review against the requirements in the final rule. For example, prior notices submitted through ABI/ACS that do not identify the site-specific manufacturer may be accepted for review initially, but upon review by FDA may be refused if they are later deemed inaccurate.
Highlights of the final rule that require careful prior notice data submission by ABI filers:
- The final rule adds a definition for "manufacturer" and provides an alternative for identifying the manufacturer when the registration number is not known. In addition to the name of the manufacturer, the prior notice submitter must submit either: (a) the registration number of the facility associated with the article of food; or (b) the full address of the site-specific facility and reason (see omitted reason codes in the bullet immediately below) why no registration number is being provided. In contrast to the IFR, the final rule requires the identity of the manufacturer for all entry types, including transportation and exportation entries. The identity of the manufacturer requirement is now currently accomplished by ABI filers through the submission of a manufacturer identification (MID) code for the identified firm.
- When the final rule takes effect, filers currently submitting prior notice using several currently used "reason" codes (reasons listed in the IFR CPG (70 Federal Register 69160, November 14, 2005) and submitted in lieu of providing the food facility registration number) may no longer do so. Specifically, reason codes G (Individual Gift – label name address in lieu of registration number), I (Samples – Quality Assurance, research or analysis purposes only), J (U.S. Manufacturing facility that is not required to register), L (unable to determine identity of the manufacturer - providing identity of manufacturer's headquarters), M (unable to determine identity of manufacturer or headquarters - providing invoicing firm's identity), and O (Gift Pack for non-business purposes – providing single prior notice and identity of packer) listed in the IFR CPG will not be accepted on or after May 6, 2009. The above listed reasons will officially be omitted from the Customs and Trade Automated Interface Requirements (CATAIR) once the CBP programming changes are completed, but should not be used after May 6, 2009. Other reasons listed in the CPG may continue to be used.
- The final rule allows, when certain conditions are met, for the submission of the express consignment operator or carrier tracking number in lieu of the anticipated arrival information, Bill of Lading, or Airway Bill number and flight number, which the IFR required. As stated in the final rule, until such time as FDA and CBP issue a determination that ACS or its successor system can accommodate such transactions, the tracking number may not be submitted in lieu of these data elements. ACS programming to allow for the submission of the courier tracking number will not be completed by May 6, 2009. Any filer wishing to submit the courier tracking number in lieu of the above listed information may do so using PNSI.
- The final rule no longer requires the submission of a fax number for the prior notice transmitter or submitter. Where ACS changes are incomplete and rejections are encountered, ABI filers may continue to include the fax number data as an optional element, or may choose to submit all zeroes in lieu of the actual number.
- The final rule now requires the submission of the complete address for the shipper, importer, owner, and ultimate consignee (now currently accomplished by ABI filers through the submission of a MID or ESS (encrypted Social Security number or encrypted tax identification (EIN) number) for the identified firm) regardless of whether the facility's food facility registration is also provided. ABI filers may continue to provide the food facility registration numbers for the subject firms in order to facilitate timely FDA review.
- The final rule does not require the submission of an HTS code for prior notice purposes. However, ABI filers should continue to submit HTS codes where required for CBP purposes.
- The final rule no longer requires the submission of the country of the license plate for privately owned vehicles, but continues to require the license plate number and the State or Province that issued the plate. Where ACS changes are incomplete and rejections are encountered, ABI filers may continue to include the country of the plate in their transactions.
Questions may be directed to the Prior Notice Center at 1-866-521-2297.