News from the Embassy of the United States of America

THE EDITOR: In mid-October of this year the United States Food and Drug Administration (FDA), which regulates food safety, published final regulations necessary to carry out major Food Safety Provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Act). These regulations will place new responsibilities on many companies and individuals within the food and animal feed industries, specifically: Registration by December 12, 2003, of all domestic and foreign facilities that manufacture, process, pack or hold food for consumption by humans or animals in the US. An online registration system is under development and will be available 24/7 once FDA publishes the final rule. Registration by mail will also be possible at that time.
 
Prior notice to FDA of each article of food imported or offered for import into the US before the food arrives at the port of entry. This requirement also takes effect on December 12, 2003. Importers, in most circumstances, will be able to provide the required information to FDA using Customs and Boarder Protection’s automated commercial system, currently used to obtain import information required by customs. Creation and maintenance of records by domestic persons that manufacture, process, pack, transport, distribute, receive, hold or import food for consumption in the US that identify the immediate previous sources and the immediate subsequent recipients of food (ie where it came from and where it went). Foreign facilities that manufacture, process, pack or hold food for consumption in the US also would have to comply with this requirement. It is critically important that all segments of the farm or sea to table food industry continuum, both those who have new responsibilities under the Act and those who are exempt, understand what they will or will not be required to do. To that end, we have enclosed an article outlining the proposed new requirements, who must comply with them, and who is fully or partially exempt. However, we emphasise that while the enclosed article reflects the regulations as they were proposed for public comment, the comments FDA receive after this date will alter some details in the final regulations.We hope you will share this information with your readers. If you have questions about the new regulations, please call the FDA press office at 301-436-2335.

Stacey Rose-Blass
Public Affairs Officer
 Embassy of the United
States of America

On June 12, 2002, President Bush signed the Public Health Security and Bioterrorism Preparedness and Response Act into law. The food provisions include new authority for the US Food and Drug Administration (FDA) to take action to protect the nation’s food supply against the threat of accidental contamination and other food-related public health emergencies. As part of implementing the Bioterrorism Act, FDA has just published two regulations. Both rules are “Interim Final Rules.” This means that the rules will go into effect, but that FDA will accept comments on certain specific issues related to the interim final rules from interested parties, both domestic and international, before publishing a final rule at a later date. By providing FDA with the flexibility to consider comments as implementation goes forward, the interim final rule process provides another mechanism to minimise disruptions to trade. Both interim final regulations are significantly different from the proposed regulations published in February 2003, in part because of the comments received from our trading partners. These measures establish new procedures for some foreign companies that export certain food, feed and live food animals to the United States. One regulation requires domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to register with the agency by December 12, 2003. For a foreign facility, the registration must include a name of the US agent for the facility. The US agent may be a person residing or maintaining a business in the United States who has been identified by the foreign facility as its agent. Such persons might include importers, customs brokers, or others with whom the foreign facility already has a business relationship. The US agent may register a foreign facility if it is authorised to do so by the facility.

The registration may be electronic, via the Internet, or by paper through surface mail. Multiple registrations from the same company may be submitted on a CD-ROM as well. There is no fee associated with registration. FDA plans to have its Internet registration system operational by October 16, 2003 to accept registrations. The Bioterrorism Act provides FDA authority to hold food from unregistered foreign facilities at the port of entry unless the FDA directs that the food be moved to a secure location. When the food must be moved, the private parties involved must arrange for moving it and promptly notify FDA of its location. The private parties would be responsible for any costs associated with moving or storage of the food. FDA will soon publish its enforcement plan for this rule. The second regulation requires that prior notice be given to FDA before food is imported or offered for import into the United States. This gives FDA advance information of imported food shipments and allows FDA to target inspections of suspect shipments more effectively to help ensure the safety of imported food products before they enter domestic commerce. In response to comments, substantial changes on the proposed rule prior notice time frames have been made in the interim final rule in order to minimise disruptions to trade. The regulation provides that Prior Notice must be received and confirmed electronically by FDA within a specific time frame that depends on the type of conveyance involved (air, land, rail, sea, or international mail). The regulation requires that FDA be given prior notice of food imported or offered for import into the US. Prior Notice must be received and confirmed electronically by FDA no more than five (5) days before arrival (except for mail) and, as specified by type of conveyance, no fewer than two (2) hours before arrival by land via land/road, four (4) hours before arrival by air or land/rail, eight (8) hours before arrival by sea, before the shipment is mailed for arrival by international mail.

In addition, by March 12, 2004, FDA will issue a plan to reduce further the prior notice time frames. The rule requires that prior notice be submitted electronically through the Bureau of Customs and Border Protection’s automated system (ABI/ACS) of FDA’s Prior Notice Interface System. FDA’s system is Internet-based and will be operational 24 hours a day, seven days a week. The US will notify the appropriate World Trade Organisation committees about the rules. FDA has also recently completed a qualitative risk assessment of the risk to, and vulnerability of, the US food supply to an act of terrorism. The agency will publish a notice of availability for the risk assessment at the same time the interim final rules are published. The US plans to conduct extensive outreach activities to provide information about the two new regulations. On October 28, there will be a satellite downlink to broadcast in which senior US officials will describe the regulations. A transcript of the broadcast and streaming video will be available on FDA’s web site. http://www.fda.gov/oc/bioterrorism/bioact.html by mid-November. FDA will also present a training seminar on the new regulations in Washington, DC on November 6 and 7. Foreign embassies in Washington have been invited to participate. Officials of the Government of Trinidad and Tobago who are in a position to disseminate this information are also invited to participate. Additional outreach plans include regional videoconferences and presentations by FDA, Customs and Border Patrol, Foreign Agricultural Service and other Embassy officials. The text of the Bioterrorism Act itself and the two new regulations, as well as press releases and fact sheets on the new regulations, are available on the web site.