Trucks show lowest FDA pre-note compliance rate

WASHINGTON, (April 12, 2004) — The U.S. Food and Drug Administration has released a summary report detailing compliance with the prior notice requirements during the initial phase of enforcement since the rule took effect last December.

The findings — which includes compliance rates and data on types of errors in submitting notices, as well as the systems used to send information — will be analyzed to help FDA focus on the areas of compliance food exporters and carriers are still having trouble with.

The second enforcement phase of the eight-month implementation plan began under the classification titled Informed Compliance and Penalties for Egregious Violators last month. Penalties will be assessed to those parties who have a history of being continuously warned for not abiding by the prior notice requirements. The third stage will commence May 13, and the complete phase of enforcement will begin August 12, 2004.

FDA reports it received over 140,000 prior notice submissions a week during February alone. About 88 per cent (130 of 145 thousand) were submitted as additional information on transactions through Customs and Border Protection’s Automated Commercial System (ACS), about 12 per cent came through FDA’s new Web-based Prior Notice System Interface (PNSI).

Slightly less than half of the total number of food articles submitted through the more popular ACS had complete prior notices. Slightly over half had some, but not all, of the prior notice information required, and only a very few lacked any of the specific prior notice information.

The report also shows that proper compliance rates for imports via land (largely trucks) generally lags behind other modes of transportation. Compliance percentage dipped as low as 40 per cent for truck carriers and owners of food shipments via truck. The low compliance rate for land carriers in ACS may indicate an area where compliance is particularly challenging, and may require further outreach and cooperation between FDA and industry to obtain full compliance, the report said.