Issue 396, March 27, 2003
As part of its increased effort to enhance security, Congress last year passed the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (further referred to as "the Act" in this document). The Act will further regulate food, drug and medical devices in an effort to safeguard them against bioterrorism. To comply with the Act by the December 12, 2003 deadline, the FDA has issued a Notice of Proposed Rulemaking (www.fda.gov) addressing the pre-importation notification requirement. Highlights of the proposed rulemaking as it impacts food importers and producers are highlighted below:

Definition of Food:
The proposed rule will require prior notice to the FDA of all food "being imported or offered for import into the United States," with "food" defined as "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used as components of any such article." "Food and feed ingredients and additives" and raw agricultural commodities are also covered, while meat, poultry and eggs are exempt from the regulation.

Who is Required to Report?
Under the proposed rule, a purchaser or importer of food, or its U.S. agent, who resides or maintains a place of business in the U. S., must submit prior notice.

When and How Must the FDA be Notified?
Subject to certain exceptions, the FDA will need to receive all information no later than noon on the day before the article will arrive at the U.S. border, with "noon" defined as 12 p.m. in the time zone in which the FDA office with responsibility over the port of entry resides. In no cases will the FDA accept information more than five days before the anticipated arrival of the food at the port of entry. The prior notice and any amendments thereto will have to be submitted electronically.

What Information is Required?
The FDA will require information relative to the manufacturer, grower or shipper of the food article(s); the carrier(s) moving the food article(s); and the importer, owner and consignee of the food article(s). Some of the required data elements include the name, address, phone number, fax number, and e-mail address of the individual submitting the notice; a complete identity of the product, its origin, shipping and port information, and U.S. Customs entry type, and will apply to "each item of food in a shipment."

What Happens if Prior Notice is Inadequate or Untimely?
Under the proposal, an article of food offered for import with no prior notice or inadequate prior notice will be refused admission. Inadequate prior notice will include notice that is untimely, inaccurate, or incomplete.

This overview simply highlights one aspect of the Act as it impacts food importers and producers. Other sections address registration of foreign and U.S. food producers, and issues germane to medical device and drug producers and importers. If you have any questions or require more information about the Act or its proposed regulations, please contact the author at rvanarnam@brc-ny.com.

Our contributing writer, F.D. "Rick" Van Arnam, is a Partner at the international trade and Customs law firm of Barnes, Richardson & Colburn in New York and can be reached at 212-725-0200 or rvanarnam@brc-ny.com.

Please note that due to the complex nature of the subject matter, DHL Danzas Air & Ocean cannot be responsible for actions taken by the reader in reliance on the information contained herein without prior consultation with DHL Danzas Air & Ocean.