FDA Releases Interim Final Rules

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October 15, 2003

FDA Releases Interim Final Rules

             On October 10, the Food and Drug Administration (“FDA”) released its interim final rules for Facility Registration and Prior Notice of Imported Food.  These regulations were mandated in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, commonly known as the Bioterrorism Act.  In accordance with the deadlines set forth in the Bioterrorism Act, each of these rules become effective on December 12, 2003.

             Section 305 of the Bioterrorism Act requires the registration of all domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the U.S.  A “facility” is defined as any establishment or structure under one ownership at one general location.  Therefore, two separate warehouses at separate locations must each submit a registration, even if they are under common ownership.  This requirement applies to all foods, including food ingredients and raw agricultural commodities, but does not apply to food contact substances or pesticides.

             Transporters operating in their normal course of business as carriers are not subject to the regulation.  Also exempt are farms; restaurants and other retail food establishments; nonprofit food establishments; and facilities that process, pack or hold food under the exclusive jurisdiction of the U.S. Department of Agriculture.  In addition, foreign manufacturing facilities do not need to register if the food undergoes processing or packaging at another facility prior to importation to the U.S., as long as the further processing or packaging is not a de minimis activity such as affixing a label.

             The registration may be submitted electronically via the internet on the FDA website portal, which was created especially for facility registration.  Facilities may also register by submitting a CD-ROM containing the required information, or by completing a paper form.  Regardless of the form, all registrations must contain the following information:

• Name, full address and phone number of the facility;
• Name, address and phone number of the parent company, if applicable;
• Names, addresses and phone numbers of the owner, operator, and agent in charge;
• All trade names the facility uses;
• The applicable FDA food product categories;
• For foreign facilities, the name, address, and phone number of the facility’s U.S. agent, discussed below;
• For domestic facilities, the phone number of the facility’s emergency contact;
• The name of the individual registering the facility;
• A statement certifying that the information is true and that the person submitting the information is authorized to do so by the owner, operator, or managing agent; and
• A statement in which the owner, operator, or agent in charge certifies that all submitted information is true and accurate.

             As indicated, foreign facilities must designate a U.S. Agent, which will act as a communications link between the FDA and the foreign facility.  The FDA will treat representations of the U.S. agent as representations of the foreign facility, and the provision of documents or information to the U.S. agent by the FDA will be considered the equivalent of providing them to the foreign facility.  As a general matter, the FDA will not hold a U.S. agent liable for violations of the Bioterrorism Act by a foreign facility, unless the U.S. agent knowingly submits false information to the FDA, or the U.S. agent and the foreign facility are effectively the same entity.  The FDA’s requirements for a U.S. agent are simply (1) residing and maintaining a place of business in the U.S., and (2) physical presence in the U.S.

             On December 12, the FDA will also begin requiring prior notice of imported food products, mandated in section 307 of the Bioterrorism Act.  The information submitted in the prior notice will be reviewed by the FDA to determine whether shipments of food pose a health threat due to terrorism or other means of contamination.  If the FDA believes, based on the information provided, that the shipment may be contaminated, it will not be permitted to enter the commerce of the U.S.

             All food for humans and animals imported or offered for import into the U.S. are subject to this rule, except for food for an individual’s personal use when it accompanies the individual upon arrival in the U.S.  The information may be filed by anyone with knowledge of the transaction, and the submitter (the person who provides the information for submission) is responsible for the accuracy of the notice. 

             Unlike facility registration, prior notice must be filed electronically.  Importers who utilize the automated broker interface’s Automated Commercial System (“ACS”) for Customs entries should use that system for their FDA submissions, as it has been enhanced to facilitate prior notice.  Other submitters must use the FDA-Prior Notice interface.  Only if both systems are down is manual submission permitted.

             The deadline for filing Prior Notice varies according to the mode of transportation.  Except for mail shipments, notice may never be submitted more than 5 days before the food items arrive at the port of arrival.  The minimum time for prior notice is as follows:

• Vessel shipments must be submitted no less than 8 hours before arrival at the port;
• Air and rail shipments must be submitted no less than 4 hours before arrival;
• Road shipments must be submitted no less than 2 hours before arrival; and
• International mail must be submitted before the package is mailed.

When prior notice is electronically filed, the system will create a confirmation that the notice has been received.  While this does not indicate that the FDA has determined that the shipment is safe, it does mean that the FDA has received all of the required information and the “clock” has begun ticking for the timeliness of prior notice.

             Prior notice must contain all of the following information:

• The name, telephone number, fax, and e-mail of the submitter—the individual or firm who provides the required information;
• The name, telephone number, fax and e-mail of the transmitter—the party who actually transmits the information to the FDA;
• Entry type;
• ACS entry line number, in-bond number or FDA-PN system generated entry number;
• Identity of the article of food, which  may include the FDA product code, common or market name of the good, the estimated quantity, and any lot or code numbers for the article of food.  Note that an “article” is a single food that is associated with the same package size, and the same manufacturer or grower;
• The manufacturer for food no longer in its “natural” state;
• The grower, if known.  This may be the harvester or collector.  However, if the grower’s identity is known to the submitter, it must be included;
• The consolidator;
• The FDA country of production;
• The shipper;
• Country from which the article is shipped, which is the country in which the food is loaded on the ultimate conveyance that brings it to the U.S.;
• Anticipated arrival information, including the anticipated date and time of arrival, and anticipated port of entry and crossing location;
• Name, and address of importer, owner, or ultimate consignee;
• Mode of transportation;
• Carrier, by SCAC or IATA code, whenever available; and
• Planned shipment information, including airway bill or bill of lading number; depending on the mode of transportation vessel name and number, flight number, trip number, container number, or license plate number; and 6-digit HTSUS code that is applicable to the article of food.

             In view of the short time frames for prior notice, the FDA does not permit amendments to the submission.  With a few exceptions, any change results in the cancellation of the original prior notice and a resubmission which must also comply with the mandatory timelines discussed above.  If there are changes to the quantity or anticipated arrival information, that data does not need to be changed and FDA need not be notified.

             If prior notice is not submitted according to the mandatory time frames of the rule, the food article must be held under a custodial bond within 48 hours.  If the refused food articles are part of a shipment that contains other articles, the refused food may be segregated from the rest of the shipment.  The refused food may not be entered for consumption, and must be stored, at the owner’s expense, until notice is given and the FDA has had an opportunity to review the information.

             For more information, or if you have any questions regarding facility registration and prior notice, please contact any office of Barnes, Richardson & Colburn.