Proposed FDA Regulations Require Prior Notice of Imports, Registration of U.S. and International Food and Beverage Facilities
February 13, 2003
On February 3, 2003, the U.S. Food and Drug Administration (FDA) proposed regulations implementing the Public Health Security and Bioterrorism Preparedness Act (BPA). The act establishes an information gathering system designed to allow the FDA to conduct more detailed surveillance of the United States food and beverage distribution system. If finalized in the present form, the proposed regulations would impose significant burdens on food and beverage manufacturers, shippers and importers. Affected industry members may submit any comments or concerns regarding certain aspects of the proposed regulations by March 5, 2003.
Central to the FDA’s proposed system are the registration of U.S. and international food and beverage producers and manufacturers and the submission of prior notice by importers or purchasers of all food and beverage imports to the United States. The new requirements, particularly the highly detailed prior notice provision, present a substantial burden for food and beverage companies worldwide. The FDA estimates that 202,000 U.S. and 205,000 international facilities will be affected by the BPA’s registration requirement, and more than 77,000 importers and consignees and 100,000 international manufacturers will be affected by the prior notice system.
For purposes of the proposed FDA regulations "food" will continue to be broadly defined as "articles for food or drink for man or other animals, chewing gum, and articles used for components of any such article." The FDA proposes to include a list of exemplary products in its rule, such as fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities, animal feed (including pet food), food and feed ingredients (including substances that migrate into food from food packaging or other articles), dietary supplements and ingredients, infant formula, nonalcoholic and alcoholic beverages, canned goods, live food animals and snack foods.
U.S. and International Company Registration
Section 305 of the BPA, as implemented in the FDA’s proposed regulations, would require all U.S. food and beverage facilities that manufacture, process, pack or hold food for human or animal consumption, whether or not food from that facility enters interstate commerce, to register with the FDA by December 12, 2003. International facilities exporting to the United States would be required to register by the same date. Facilities that must register include those that produce foods and animal feed products regulated by the FDA, including dietary supplements, infant formula, alcoholic and nonalcoholic beverages and food additives. The proposed rule exempts farms, restaurants, retail and nonprofit food establishments, in addition to other facilities, such as slaughterhouses and other meat or poultry processors, which are regulated entirely by the U.S. Department of Agriculture (USDA).
International facilities will be exempt from the registration requirement if food and beverages from a facility undergo further processing or packaging by another international facility before export to the United States. However, if the further processing or packaging is of a de minimis nature, for example, the further processor merely affixes a label to the initial processor’s product, both the initial international facility and the company performing the de minimis activity must register with the FDA.
Comments might be appropriate regarding the following: how de minimis levels are determined; the imposition of a registration requirement on intermediate processors; the registration requirement for intrastate shippers; the number and nature of affected products; and the severity of the penalty for failure to comply.
Prior Notice of Imports
Section 307 of the BPA, as implemented in the FDA’s proposed regulations, requires that advance electronic notice be given by the purchaser or importer to the FDA of all foods and beverages imported or offered for import into the United States beginning December 12, 2003. By requiring prior notice, the FDA seeks to enhance its ability to detect accidental and intentional contamination of food and beverages and to deter deliberate contamination of the U.S. food and beverage supply by providing the FDA inspectors with adequate time to respond to shipments that might be tainted. The FDA’s proposed regulations establish the period of advance notice to the FDA as not less than eight hours (12:00 p.m. EST the day before arrival at a U.S. port at the latest) and not more than five days before the importation. In the event that prior notice is not submitted to or received by the FDA, the food and beverage will be refused entry into the United States and held until adequate notice is given. Additionally, until the U.S. Customs Service has its Automated Customs Environment electronic system operational and synchronized with the FDA system, importers will be required to file separate prior notices with both agencies.
According to the FDA’s proposed regulations, proper notice must include information such as the name of the firm and individual submitting the notice; U.S. Customs identification numbers for the shipment; identity of the article of food and beverage (including the complete FDA product code, the common or market name of the product, the trade or brand name, quantity described from smallest package to largest container and lot or code numbers for the food); the manufacturer’s name; and the names of all growers. The notice must also include information including the country of origin, the shipper’s name, the country from which the food was shipped, names of the importer, owner and consignee and the carrier. Only one amendment may be made to the notice of importation no later than two hours before the arrival of the shipment, and the amendment may not be used to change the nature of the article of food or beverage.
Comments might be appropriate regarding the following: the need to submit more than one amendment to the prior notice; the restrictive nature of the amendment; the restrictive time frame for submitting a prior notice; the severity of the penalty for failure to comply; and the level of detail required in each notice.
Penalties for Failure to Register or Provide Notice
Any failure of facilities or companies to register by the December 12, 2003, deadline could result in the FDA’s filing of a civil action to enjoin the unregistered company’s activities or a criminal action against the individuals responsible for committing any prohibited activity. Additionally, food and beverages imported to the U.S. from unregistered international facilities will be held at the port of entry. Imported foods or beverages that are not preceded by proper notice will be refused entry into the United States. In all instances where food and beverages are held, the carrier or the person responsible for registering or submitting prior notice will be responsible for making arrangements and paying for costs associated with moving the items to secure locations. Conviction of a food-related felony could, among other things, lead to a company or individual’s debarment from conducting business with the United States.
Submitting Comments and Achieving Compliance
At present, the FDA intends to issue final rules by October 12, 2003. Comments on provisions covering the collection of information by FDA are due by March 5, 2003. General comments on other aspects of the proposed regulations must be submitted by April 4, 2003. If you are interested in commenting on the proposed regulations or require assistance in achieving compliance with this changing regulatory system, please contact Robert Hibbert, David Baron or Jay Taylor, resident in McDermott, Will & Emery's Washington, D.C. office. McDermott, Will & Emery’s Washington, D.C. office has one of the largest and most experienced food and agriculture practices in the United States, as well as a substantial international trade practice that serves clients affected by the regulations.
