UNITED STATES FOOD AND DRUG ADMINISTRATION
INTERIM FINAL REGULATIONS –
REGISTRATION OF FOOD FACILITIES
NOTICE PRIOR TO IMPORT
EXECUTIVE SUMMARY
Prepared by Olsson, Frank and Weeda, P.C.
Washington, D.C. USA
October 10, 2003
The United States Food and Drug Administration (FDA) has issued two interim final regulations, requiring registration of food facilities and prior notice of food imports to FDA. The interim final regulations published in the October 10, 2003 United States Federal Register and may be accessed at www.usafoodagents.com. These interim final regulations are the first two of four FDA regulations implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act).
The interim final regulations affect most U.S. and foreign entities that manufacture, hold, process, distribute, grow, or import food products for the United States market. “Food” is defined very broadly in these regulations to cover all human and animal food regulated by FDA, including food ingredients, dietary supplements, fresh produce, fish and seafood, alcoholic beverages, live animals to be processed into food, animal feed, and pet food. It does not include food contact substances, such as food packaging.
These interim regulations are effective beginning December 12, 2003. However, these interim regulations may change. FDA is accepting comments from interested persons for the next 75 days. In March 2004, the agency will reopen the comment period on the regulations for an additional 30 days and then issue final regulations. During this time, FDA intends to emphasize educating industry about the new requirements. FDA is not expected to begin strictly enforcing the prior notice and registration regulations until after it has issued final regulations.
Olsson, Frank and Weeda, P.C., a Washington, D.C. law firm specializing in food law, has prepared this executive summary of these important regulations for the food industry. The following is not intended as legal advice. An entity involved with food products intended for consumption in the United States should discuss the legal ramifications of these interim final regulations with counsel.
Facility Registration Interim Final Regulations
The key features of the interim final registration regulations are:
· Any domestic or foreign facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States is required to register the facility with the FDA by December 12, 2003, unless the facility is exempt.
· Facilities exempt from registration include: farms; retail food establishments whose principal business is selling food directly to consumers; restaurants; private residences; transport vehicles that hold food only in the usual course of business; nonprofit food establishments; fishing vessels not engaged in processing; and facilities regulated exclusively throughout the entire facility by the U.S. Department of Agriculture.
· Foreign facilities are exempt from registration if food from such facilities undergoes further manufacturing/processing or packaging (of more than a de minimis nature) at another foreign facility before it is exported to the U.S. This means that the last foreign facility that manufactures/processes or packages the food, and any subsequent foreign facility that packs or holds the food, must register.
· Foreign facilities required to register must also designate a “U.S. agent” who must live or maintain a place of business in the United States and be physically present in the United States.
· The owner, operator, or agent in charge of a covered facility (or an individual they authorize) must submit the registration to FDA.
· The new registration requirement requires registration of covered facilities, not companies. A single company may be required to register multiple facilities.
· Facilities will have until December 12, 2003 to register by completing the Form FDA 3537. Facilities can register by logging on to www.fda.gov/furls beginning October 16, 2003, by mailing or faxing the completed form to FDA, or by sending a CD-ROM with the required information to FDA. A facility registering via the Internet will receive confirmation and its registration number “instantaneously.” Receipt of a registration facility number will take longer if a facility registers by mail or CD-ROM.
· The registration must contain the following information:
o The name, address, and phone number of the food facility and, if applicable, its parent company.
o The name, address, and phone number of the owner, operator, or agent in charge.
o For foreign facilities, the name, address, phone number, and emergency contact number of the “U.S. agent.”
o For domestic facilities, an emergency contact phone number.
o All trade names used by the facility.
o The categories of food products manufactured/processed, packed, or held at the facility as identified in FDA’s regulation, 21 C.F.R. § 170.3.
o A certification that that the information submitted is true and accurate.
· If any of the required information listed above changes, the registrant must submit an updated Form 3537 to FDA within 60 days of the change.
· If a facility is required to register, it is a violation of United States federal law to fail to register. If a foreign facility required to register fails to do so and food from that facility is offered for import into the U.S., the Bioterrorism Act requires that the food be held at the port of entry.
Prior Notice Interim Final Regulations
The prior notice interim final regulations will affect the importation of all food products into the United States. The interim final regulations impose requirements that are in addition to, but will be incorporated with, existing notification procedures importers now follow when reporting their food imports (FDA’s Operational and Administrative System for Import Support (OASIS) system and the Bureau of Customs and Border Protection's (Customs) Automated Broker Interface (ABI) of the Automated Commercial System (ACS)).
The regulations take effect on December 12, 2003. Beginning on that date, all articles of food offered for import into the United States will not be permitted to enter the United States unless they are covered by an adequate prior notice.
The key features of the prior notice interim final regulations are:
· Anyone with knowledge of the required information may submit the prior notice, including, but not limited to, brokers, importers, and “U.S. agents.”
· Prior notice must be received and confirmed electronically by FDA no more than 5 days before arrival and, before the following time, depending upon mode of transportation:
o 2 hours before arrival by road.
o 4 hours before arrival by air or by rail.
o 8 hours before arrival by water.
o Before mailing if food is sent by international mail.
· The prior notice must be submitted to FDA electronically. The notice may be submitted through the ABI/ACS interface by a customs broker or through FDA’s new FDA Prior Notice (PN) System Interface at www.access.fda.gov.
· The prior notice must contain the following information:
o The submitter, including name, telephone and fax numbers, email address, and firm name and address.
o The transmitter (if different from the submitter).
o Entry type and CBP identifier.
o The article of food, including complete FDA product code, 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).
o The manufacturer.
o The grower (if known).
o The country of production.
o The shipper, except for food imported by international mail.
o The country from which the article of food is shipped or, if the food is imported by international mail, the anticipated date of mailing and country from which the food is mailed.
o The anticipated arrival information (location, date, and time) or, if the food is imported by international mail, the U.S. recipient (name and address).
o The importer, owner, and ultimate consignee, except for food imported by international mail or transshipped through the United States.
o The carrier and mode of transportation, except for food imported by international mail.
o Planned shipment information, except for food imported by international mail.
· If any of the following required information changes after confirmation, then a new prior notice must be submitted:
o The submitter or transmitter.
o Entry type and CBP identifier.
o The article of food, except the estimated quantity.
o The manufacturer, grower, shipper, importer, owner, or consignee.
o The FDA “Country of Production.”
o The country from which the article of food is shipped or, for food imported by international mail, the anticipated date of mailing.
o The U.S. recipient (name and address) if the food is imported by international mail.
o The carrier and mode of transportation.
o Planned shipment information unless the food will not be imported.
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U.S.A. Food Agents, LLC is a joint venture between The Food Institute and the law firm of Olsson, Frank and Weeda, P.C. The Food Institute is a non-profit organization that has been serving the educational and information needs of the food industry since 1928. The Washington, D.C. law firm of Olsson, Frank and Weeda, P.C. has been advising clients on food law and FDA regulatory requirements since 1979, and includes several attorneys who used to work at FDA. Please call U.S.A. Food Agents, LLC at 866-40AGENT (866-402-4368) for more information or visit our websites for complete summaries of FDA’s interim final regulations and other important information: www.usafoodagents.com; www.foodinstitute.com; and www.ofwlaw.com.
U.S.A Food Agents, LLC is private company. It not a part of or affiliated with the United States government.
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