Great Lakes has now obtained Phase Two filing status with the FDA (commonly referred to as “paperless” status) in the port of Buffalo, NY, which includes the Peace Bridge and Queenston-Lewiston Bridge crossings and the Port of Champlain, NY. We had previously obtained paperless status in Detroit, Port Huron, & Sault Ste. Marie, Michigan. We are now working closely with the FDA to achieve paperless status in the port of Alexandria Bay, New York. We wish to thank ALL of you for your cooperation in reaching this goal.  Please read on… there is additional, important information contained in this e-mail.

Great Lakes Customs Brokerage is committed to achieving “paperless” status for all entries regulated by the Food & Drug Administration (FDA) in all ports of entry.  Paperless Status is important because it (1) speeds the release process and (2) provides electronic notification of release status to Great Lakes so that we can provide electronic release status to you. SmartBorder.com ™ (Great Lakes’ internet system) users can view the FDA status of their own entries online – immediately – in real time, as the messages are returned from the FDA. For complete instructions for how, please contact your Great Lakes Customer Service Team.  Non-SmartBorder ™ users should contact their account representative for information on how to sign up for the software.

Now that we are paperless in our primary ports, it is vitally important that we maintain paperless status. The FDA will be performing periodic, unannounced audits in order to ensure compliance. The FDA has added significant resources to increase its surveillance of both domestic and imported foods. The audit process is rigorous and more companies are being removed from paperless filing status than are retaining their status or being added. Great Lakes Customs Brokerage is committed to working closely with our clients to ensure FDA compliance is maintained.

How can you help? Please make sure that you have provided product information, product labels, and/or ingredient listings to your Great Lakes customer service team for all of your FDA-regulated products. Provide advance notice regarding any new regulated products prior to shipping.

FDA's electronic screening of each entry requires that Great Lakes provide the following additional information:

• FDA product code (FDA's product code is not the same as the HTS codes used for Customs screening purposes). The FDA product code consists of five components that provide FDA with specific information about the product. For example, for food products, the product code will identify what the product is, what the product is packaged in (e.g. plastic or glass) and how it is processed (e.g. is it pasteurized, irradiated, or commercially sterile).
• The Manufacturer Identification (MID) code indicating their company name and address. The MID code for the foreign shipper, which may or may not be the same as the manufacturer.
• The country of origin (which may be different from the country of origin identified for Customs purposes).

Food importers will have to double up on their advance cargo-reporting in order to comply with anti-terrorism laws. The Food and Drug Administration (FDA) announced late Wednesday that importers of food, ingredients or animal feed will have to file notice of arrival for food products at the latest by noon of the day prior to the shipment's scheduled arrival, but no more than five days before arrival. At the same time, a second proposed rule will require all foreign producers, shippers, carriers, storage facilities, and U.S. importers and distributors of foreign-processed food and ingredients to register with the FDA. The FDA's new rules come as the U.S. Custom Service rule requiring advance filing of import cargo manifests for all modes of transport is set to take effect later this year. The FDA has set Oct. 12 as the effective date for the rules, and Dec. 12 to begin enforcement. Both rules implement portions of the Public Health Security and Bioterrorism Preparedness and Response Act that Congress passed in June 2002. Joseph Levitt, director of the FDA's Center for Food Safety and Applied Nutrition, said that the double-reporting is necessary to meet congressional deadlines. The U.S. Customs Service collects much of the same data in its Automated Commercial System, but the system cannot be re-programmed to accept the data that FDA requires, he said. Levitt said that the two advance-notice systems will merge when Customs completes work on the new Automated Commercial Environment in 2005. FDA officials said the agency's goal is to make its advance-notice requirements as easy as possible to comply with, although they acknowledged that the requirements may force changes in current business practices.