FDA and Customs issued a revised compliance policy guide (CPG) that describes their strategy for enforcing the requirements of the prior notice interim final rule (IFR). The prior notice requirement went into effect Dec. 12. Since February, an average of approximately 160,000 prior notice submissions have been made each week.
Under the revised CPG, FDA and Customs will enforce fully all provisions of the prior notice IFR beginning today, except for the following violations:
· 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;
· and 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.
For these violations, the two agencies generally will continue to exercise enforcement discretion until Nov. 1, unless the violation reflects a history of the repeated conduct of a similar nature by a person who had been notified of such violations.
The revised CPG also states the agencies will exercise enforcement discretion for prior notices that fail to include a required manufacturing facility registration number if the food imported or offered for import is for quality assurance, research or analysis purposes only (i.e., not for human or animal consumption and not for resale).
FDA and CBP also announced a three-month delay in their projected date for issuing the prior notice final rule, from March 2005 to June 2005. FDA and Customs said the delay will allow them time to determine whether the prior notice time frames can be reduced further as they develop the prior notice final rule.
