Bioterrorism Act Interim Final Rules

Failure to understand the new interim regulations could result in penalty or detained shipments.

By Todd Harrison & Todd Halpern

On October 10, 2003, FDA published two interim final rules in the Federal Register implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act”). The rules address the following provisions of the Bioterrorism Act:
• The requirement to register all “facilities,” both foreign and domestic, which manufacture, process, pack or hold food for human or animal consumption in the United States; and
• The requirement that a company provide FDA with prior notice of all imported shipments of food into the U.S.
Failure to comply with these rules may result in civil or criminal penalties, or may lead the Customs and Border Protection to detain a shipment at the border, or refuse its admission.

Registration Requirements

Companies must register all “facilities,” as FDA defines that term. A parent company may register all of its facilities; however, each facility must be registered separately and each will receive a separate registration number. FDA suggested that one way to determine whether a business is one or two facilities is through examining real estate records. According to FDA, a property line could demonstrate that several buildings are on the same lot, and therefore are the same facility. The number of registrations that will have to be completed for a company owning more than one building will have to be determined on a case-by-case basis.

All facilities must be registered by December 12, 2003. All facilities, both foreign and domestic, that manufacture/process, pack, or hold food for consumption in the U.S., must be registered by December 12, 2003. The registration for each facility must be completed by the owner, operator or agent in charge, or an individual authorized by them. A domestic facility must register whether or not food from the facility enters interstate commerce. Registration does not require payment of a fee.

Foreign facilities must designate a U.S. agent, who lives or maintains a place of business in the U.S., unless the foreign facility is exempt.

A foreign facility that manufactures/processes, packs or holds food is exempt and does not have to register if the food is processed further at another foreign facility. This exemption does not apply, however, if the further processing is de minimus (e.g., affixing a label).

Any individual residing in the U.S., who is authorized by the owner, operator or agent in charge of the facility, may register the facility. A foreign facility may have a single U.S. agent for FDA registration purposes, and have multiple agents (such as foreign suppliers) for other business purposes. A firm’s commercial business in the U.S. need not be conducted through the U.S. agent designated for purposes of registration.

The online Internet registration system became available for use on October 16, 2003. Facilities do not need to re-register. But changes in registration information must be submitted in an update to the facility’s registration within 60 days of the change. (Note that this differs from the 30 days given in the proposed rule.) Such updates can be done via the Internet.

Registration requires the following information for each facility:
• Name, full address and phone number for the facility, parent company and owner, operator and agent in charge of facility (this interim final rule no longer requires fax numbers and E-mail addresses, but it does request that they be provided as optional information);
• For a foreign facility, name, address, phone number for the emergency contact or U.S. agent;
• For domestic facility, emergency contact phone number;
• All trade names for the facility;
• Applicable food product categories (as specified in 21 C.F.R. 170.3—e.g., grain products or snack foods.); and
• A statement certifying that the information is true and accurate—if the registration is submitted by an agent or authorized individual who is not in charge of the facility then he or she submits the statement of truth and accuracy.

Prior Notice Requirements

Prior notice of all food imported into the U.S. must be made beginning December 12, 2003. Prior notice must be made electronically, either through FDA’s Prior Notice (PN) System Interface, or through the Bureau of Customs and Border Protection’s (CBP) Automated Broker Interface of the Automated Commercial System (ABI/ACS). According to the FDA, most of the prior notice information re­quired by the regulation is data usually provided by importers or brokers to the CBP when food arrives in the U.S.

Notice must be received and confirmed electronically no more than five days before arrival and no fewer than:
• Two hours before arrival by land via road;
• Four hours before arrival by air or by land via rail; or
• Eight hours before arrival by water.

Prior notice may be submitted by any individual with knowledge of the required information, including, but not limited to, brokers, importers and U.S. agents.

Prior notice must include the following information:
• Firm name and address;
• Name, address, phone number, fax number and E-mail address of submitter (and of transmitter, if different);
• Entry type (e.g., consumption entry, warehouse entry, temporary importation bond entry, etc.) and CBP identifier;
• Identification of the article of food, including complete FDA product code (www.accessdata.fda.gov/scripts/ora/pcb/pcb.htm), the common or usual name or market name, the estimated quantity described from the smallest package size to the largest container, and the lot or code numbers or other identifier (if applicable);
• The manufacturer and registration number for the facility associated with the food (unless the food is imported for transshipment, storage and export, or further manipulation and export);
• The grower name and address—if the product has been consolidated then the name and address of any grower or consolidator;
• FDA Country of Production;
• Shipper (person who arranges for a shipment to get to its first destination in the U.S.—typically responsible for initiating the bill of lading or air bill covering the transportation of the article by the carrier) and shipper’s registration for the relevant shipping facility;
• Country from where the article is shipped;
• Anticipated arrival information, including anticipated port of entry and the anticipated date and time of arrival;
• Importer, owner and ultimate consignee’s name and address;
• Mode of transportation;
• Standard Carrier Abbreviation Code or International Air Transportation Association code of the carrier; if not available, then the name and country of the carrier; and
• Planned shipment information details such as Bill of Lading number, vessel name and voyage number (by sea), air carrier and flight number (by air), trip and car number (by rail, truck or bus), container numbers and Harmonized Tariff Schedule (HTS) Code.

Changes to information already submitted require resubmission of prior notice.

Exceptions include changes in: (1) quantity; (2) anticipated arrival information; or (3) planned shipment information. If prior notice is resubmitted, then the previous prior notice must be canceled.NW