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T04-29 |
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The United States Food and Drug Administration (FDA) and the U.S. Customs and Border Protection (CBP) today issued a revised compliance policy guide (CPG) that describes their strategy for enforcing the requirements of the prior notice interim final rule (IFR) while maintaining an uninterrupted flow of food imports.
The prior notice provision in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) gives FDA advance information of imported food shipments. This allows FDA to target inspections more effectively and helps to ensure the safety of imported food products before they enter domestic commerce. FDA and CBP began receiving prior notices on December 12, 2003, when the Prior Notice IFR took effect, and since February 2004, have been receiving about 160,000 prior notice submissions a week. The prior notice IFR has proven to be an important tool in the nation’s food defense efforts.
Under the revised CPG, FDA and CBP will enforce fully all provisions of the prior notice IFR on August 13, 2004, except for the following violations:
For these violations, the two agencies generally will continue to exercise enforcement discretion until November 1, 2004, 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 that 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 initially published the CPG in December 2003, and revised it in June 2004, to include additional guidance regarding food imported or offered for import for non-commercial purposes with a non-commercial shipper. Enforcement discretion for these shipments continues under the revised CPG.
FDA and CBP also are announcing a corresponding three month delay in their projected date for issuing the prior notice final rule from March 2005 to June 2005. This will allow FDA and CBP to retain the three month assessment period to determine whether the prior notice time frames can be reduced further as they develop the prior notice final rule.
Lastly, the agencies are announcing the issuance of an updated prior notice compliance summary and a new “Guidance for Industry: Prior Notice of Imported Food Contingency Plan for System Outages.” The compliance summary states that since increased enforcement began in June, entries submitted to FDA and CBP with no prior notice have been almost eliminated. Although some problems still exist, only a small percent fail to submit any prior notice information. Most prior notice data are being submitted; however, completion of registration number and bill of lading is lower than completion of most other data elements.
FDA and CBP also are looking more closely at the validity and consistency of the data that are being entered. For example, although a consignee is entered on 100% of the submissions through ACS, almost 2% of consignee data (which as an example, equated to 2,466 for the week ending July 3rd) indicates unknown/consolidated consignee, and not the ultimate consignee as required by the prior notice IFR. FDA and CBP now are actively identifying specific submitters and transmitters (broker/filers) whose submissions tend to be error prone and are providing information to industry to encourage better compliance. The agencies also are using the results of our compliance information to review some of the most problematic compliance areas to determine how to best improve compliance rates. The agencies intend to continue their education and outreach efforts to industry through November 1, 2004.
The Contingency Plan provides guidance on submitting prior notice of imported
food during system outages affecting the applicable FDA and CBP computer
program systems. The contingency plan identifies seven potential
system downtime scenarios that could impact transmission, confirmation,
and processing of prior notice submissions and explains recommended submission
options for each of the identified scenarios. In any of the scenarios described
in the contingency plan, where the alternate submission options include
both e-mail and facsimile (fax) transmissions, e-mail transmission
is strongly encouraged as the more efficient means.
For more information:
Compliance Summary Information: Prior Notice http://www.cfsan.fda.gov/~pn/pnsum.html
Revised Compliance Policy Guide http://www.cfsan.fda.gov/~pn/cpgpn3.html
Revised Joint Plan: http://www.cfsan.fda.gov/~pn/pnplan2.html
Prior Notice Contingency: http://www.cfsan.fda.gov/~pn/pndguid.html
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