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NOTICE: THESE REGULATIONS REQUIRING REGISTRATION AND APPOINTMENT OF A U.S. AGENT ARE NOW IN EFFECT. DEADLINE FOR REGISTRATION: BEFORE YOUR NEXT SHIPMENT LEAVES
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act or the Act) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to appoint a US Agent and register with the FDA. The first in a series of rules required by the Bioterrorism Act to permit FDA to respond quickly to a threatened or actual terrorist attack on the U.S. food supply, appointment of a U.S. Agent and registration will assist FDA to determine the location and cause of a potential threat and permit the agency to quickly notify facilities that might be affected.
Who must register under the proposal? Owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack,or hold food for human or animal consumption in the United States would be required to register the facility with the FDA. Domestic facilities will be required to register whether or not food from the facility enters interstate commerce. Foreign facilities that engage in the above activities also would be required to register unless food from that facility undergoes further processing or packaging by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities would be required to register.
What facilities are exempted from registration? Exempt from registration compliance requirements are farms; retail food operations; restaurants; non-profit operations that prepare food for, or serve food directly to, consumers; fishing vessels not engaged in processing [as defined in 21 CFR 123.3 (k)]; and facilities regulated exclusively throughout the entire facility by the U.S. Department of Agriculture.
What will happen if facilities fail to register? The Bioterrorism Act makes failure to register a prohibited act. The Federal government can bring a civil action in Federal court to enjoin persons who commit a prohibited act; or the Federal government can bring a criminal action in Federal court to prosecute persons who commit a prohibited act. If foreign facilities fail to register and also attempt to import food into the U.S., the Bioterrorism Act requires that the food be held at the port of entry unless FDA directs that it be moved to a secure location. FDA is proposing that, when the food must be moved, the private parties involved (i.e., the owner, purchaser, importer, or receiver of the food) 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.
What methods of registration are there? Registration may be electronic, via the Internet, or by paper through surface mail. However, the agency strongly encourages electronic registration because it will be faster and more convenient. The system is able to accept electronic registrations from anywhere in the world 24 hours a day, 7 days a week. A registering facility will receive confirmation of electronic registration and its registration number instantaneously once all the required fields on the registration screen are filled in. Registration by mail may take several weeks to several months, depending on the speed of the mail system and the number of paper registrations that FDA will have to enter manually.
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HHS Secretary Tommy G. Thompson today announced the issuance of two Food and Drug Administration regulations that will bolster the safety and security of America's food supply. The new regulations will enable better targeted efforts to monitor and inspect imported foods and will allow quick identification and notification of food processors and other establishments involved in any deliberate or accidental contamination of food.
" By requiring advance notice for imported food shipments and registering domestic and foreign food facilities, we are providing critical new tools for the FDA to identify potentially dangerous foods and better keep our food supply safe and secure," Secretary Thompson said. " These new requirements represent the latest steps in our ongoing efforts to respond to new threats and improve the safety of all the foods that we eat in this country,"
The two new regulations will implement key provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which provided FDA new authority to protect the nation's food supply against actual or threatened terrorist acts and other food-related emergencies.
The first regulation requires food importers to provide the FDA with advance notice of human and animal food shipments imported or offered for import on or after Dec. 12, 2003. This will allow FDA to know, in advance, when specific food shipments will be arriving at U.S. ports of entry and what those shipments will contain. This advance information will allow the FDA, working with U.S. Customs and Border Protection (CBP), to more effectively target inspections and ensure the safety of imported foods. The FDA expects to receive about 25,000 notifications about incoming shipments each day.
The second 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 Dec. 12, 2003. As a result, FDA will have for the first time a complete roster of foreign and domestic food facilities. The requirements will enable the FDA to quickly identify and locate affected food processors and other establishments in the event of deliberate or accidental contamination of food. The FDA expects about 420,000 facilities to register under this requirement.
Under the prior notice regulation, prior notice of imported foods must be received and confirmed electronically by FDA no more than five days before its 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. In addition, for international mail shipments, notifications must be made before the shipment is mailed. Also, when an individual carries or otherwise transports foods subject to the new requirement, advance notice of two, four or eight hours is required -- depending on the mode of transportation. The food must also be accompanied by confirmation of receipt for FDA review. .
The advance notice to the FDA may be submitted electronically in most circumstances using Customs' existing ABI/ACS system, making it easier for importers to comply with the new law. In addition, the FDA will operate a new Prior Notice System Interface that can receive such notifications.
The second regulation requires the owner, operator, or agent in charge of a domestic or foreign food facility to register with FDA, providing information about the name and address of each facility at which, and all trade names under which, the registrant conducts business, and information about certain categories of food the facility produces. For a foreign facility, the registration must include the name of the U.S. agent for the facility.
Registration is required for domestic facilities whether or not food from the facility enters interstate commerce. Domestic facilities are also required to provide emergency contact information. All changes to such information must be reported within 60 days. Except for specific exemptions, the registration requirements apply to all facilities that manufacture, process, pack or hold food regulated by FDA, including animal feed, dietary supplements, infant formula, beverages (including alcoholic beverages) and food additives
Registration would not be required for private residences of individuals; certain food transport vehicles; facilities that manufacture food contact substances and pesticides; farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; non-processing fishing vessels; and facilities (such as meat and poultry slaughterhouses) that are regulated exclusively by the U.S. Department of Agriculture. Also exempt are foreign facilities if the food from the facility is to undergo further processing or packaging by another facility before it is exported to the U.S.
The rules take effect Dec. 12, 2003, in accordance with the Bioterrorism Act. To assure that the regulations can be implemented efficiently and with minimal disruption, FDA intends to exercise broad enforcement discretion for the prior notice rule for the first four months after implementation. During this time, FDA and CBP will educate importers about how they can comply with the regulations, and will work with trade associations and foreign governments to make sure all importers are well informed of the new requirements. Thereafter, FDA will phase in full implementation of the prior notice requirements.[end of October 9, 2003, Press Release)
(NOTE from Press Release of January 29, 2003): Under the Bio-terrorism Act, it is a prohibited act for a facility to not be registered by December 12, 2003. If a firm does not register by the deadline, the United States can bring a civil action in federal court to enjoin persons who commit a prohibited act; or it can bring a criminal action in federal court to prosecute persons who commit a prohibited act. The Bioterrorism Act also requires food from unregistered foreign facilities to be held at the port of entry unless the FDA directs that the food be moved to a secure location. [portions adapted for publication]
[portions adapted for publication from a similar agent program]As stated earlier, section 510(i) of the act requires foreign establishments to identify a United States agent. The preamble to the proposed rule explained that FDA interpreted this provision as requiring the agent to be an individual, firm, or company physically located in the United States (see 64 FR 26330 at 26331). The preamble to the proposed rule added that the United States agent could not be a mailbox, answering machine or answering service, or any other place where an individual acting as the foreign establishment's agent is not physically present.
As for advising foreign establishments to select their United States agents carefully, FDA was emphasizing that its interactions with a United States agent could involve proprietary information, particularly in emergency situations (see 64 FR 26330 at 26334). FDA must be able to communicate freely with a United States agent in these situations; otherwise, if the United States agent is unable or unauthorized to speak to FDA, the United States agent has little or no value in serving as a contact between FDA and the foreign establishment. FDA takes no position whether a foreign establishment should select a U. S. distributor to be its United States agent.
The United States agent would be responsible for assisting FDA in communications with the foreign establishment, responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assisting FDA in scheduling inspections of the foreign establishment. The proposal also authorized FDA to provide information or documents to the United States agent if FDA is unable to contact the foreign establishment directly or expeditiously
Several comments asked about the United States agent's liability...expressed concern about the United States agent's exposure to litigation from parties in the United States who sue the foreign establishment....they had surveyed various U. S. firms or contacted U. S. attorneys and found that none were willing to act as a United States agent; U. S. firms were concerned about their potential legal liability.
If a foreign establishment violates the act, FDA would pursue action against that foreign establishment. Examples of instances where FDA might take action against the United States agent would be where the agent submitted false information to FDA or the agent and the foreign establishment were effectively the same entity.
As for the United States agent's liability in third party litigation (i.e., situations where a private party sues the foreign establishment and attempts to attach or enforce a judgment by attaching the United States agent's assets), such issues are beyond the scope of this rule. FDA does not have authority to insulate United States agents from such litigation, and such litigation would be a matter of State, rather than Federal, law.
One comment would permit a United States agent to notify FDA about changes to its name or address or even whether a person no longer serves as a foreign establishment's United States agent.
FDA agrees and has revised Secs. 207.40(c)(3), 607.40(d)(3), and 807.40(b)(3) so that United States agents may report changes themselves
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires that FDA receive prior notice of food imported into the United States, beginning on December 12, 2003. Most of the prior notice information required by the interim final rule is data usually provided by importers or brokers to the Bureau of Customs and Border Protection (CBP) when foods arrive in the United States. Now, the Bioterrorism Act requires that this information also be provided to FDA in advance of an imported food's arrival to the United States. FDA will use this information in advance of the arrival to review, evaluate, and assess the information, and determine whether to inspect the imported food. FDA and CBP have collaborated on the implementation of the prior notice interim final rule. Nearly all of the current imported food shipments can comply by using CBP's Automated Broker Interface of the Automated Commercial System (ABI/ACS). Prior notice can be submitted either through ABI/ACS or FDA's Prior Notice (PN) System Interface beginning December 12, 2003.
When must prior notice be submitted? Prior notice must be received and confirmed electronically by FDA no more than 5 days before arrival and, as specified by the mode of transportation below, no fewer than: 1. 2 hours before arrival by land by road 2. 4 hours before arrival by air or by land by rail 3. 8 hours before arrival by water 4. The time consistent with the timeframe established for the mode of transportation for an article of food carried by or otherwise accompanying an individual if it is subject to prior notice (The food must also be accompanied by the FDA confirmation.) In addition, prior notice must be received and confirmed electronically by FDA before food is mailed by international mail. (The parcel must be accompanied by confirmation of FDA receipt of prior notice.)
How must the prior notice be submitted? Prior notice must be submitted electronically. FDA estimates more than 80 percent of prior notice of imported food shipments submissions can be transmitted through ABI/ACS. Prior notice for international mail food shipments, other transaction types that cannot be made through ABI/ACS, or articles of food that have been refused admission under section 801(m)(1) of the Federal Food, Drug, and Cosmetic Act must be submitted to the FDA PN System Interface at www.access.fda.gov. Beginning on December 12, 2003, for technical assistance in submitting prior notice: • For the United States, call 1-800-216-7331 or 301-575-0156 • From all other countries and locations, call 301-575-0156 • Send a fax to 301-210-0247 This technical assistance will be available on business days from 7 AM until 11 PM U.S. Eastern Time. Requests for assistance also may be emailed to furls@fda.gov. For assistance with ABI/ACS transmission, contact your CBP client representative.
Both the CBP and FDA systems for prior notice will be available 24 hours a day, 7 days a week for information submission beginning December 12, 2003. If the ABI/ACS is not working, then prior notice must be submitted using the FDA PN System Interface. If the FDA PN System Interface does not appear to be working properly, the online Help Desk should be contacted first. If the system is not working, then the required prior notice information, which appears in the interim final rule and will be listed on FDA's website, must be submitted by fax or email.
Who must submit prior notice? Any individual with knowledge of the required information may submit the prior notice, including, but not limited to, brokers, importers, and U.S. agents.
What food is subject to the requirement for submitting prior notice? Prior notice applies to food for humans and other animals that is imported or offered for import into the United States. For purposes of the interim final rule, "food" is defined by reference to section 201(f) of the Federal Food, Drug, and Cosmetic Act. Section 201(f) defines "food" as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such articles. Examples of "food" include: • Dietary supplements and dietary ingredients • Infant formula • Beverages (including alcoholic beverages and bottled water) • Fruits and vegetables • Fish and seafood • Dairy products and shell eggs • Raw agricultural commodities for use as food or components of food • Canned and frozen foods • Bakery goods, snack food, and candy (including chewing gum) • Live food animals • Animal feeds and pet food
What foods are excluded from the prior notice requirement? Foods that are excluded from the prior notice requirement are: (1) food carried by or otherwise accompanying an individual arriving in the United States for that individual's personal use (i.e., for consumption by themselves, family, or friends, and not for sale or other distribution); (2) food that is exported without leaving the port of arrival until export; (3) meat food products, poultry products and egg products that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act; and (4) food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the United States.
Will FDA provide confirmation of receipt of prior notice? Yes. FDA will issue a confirmation of prior notice to the transmitter upon successful receipt of the prior notice information.
What information must be included in the prior notice? The prior notice must be submitted electronically and contain the following information: • Identification of the submitter, including name, telephone and fax numbers, email address, and firm name and address • Identification of the transmitter (if different from the submitter), including name, telephone and fax numbers, email address, and firm name and address • Entry type and CBP identifier • The identification of 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) • The identification of the manufacturer • The identification of the grower, if known • The FDA Country of Production • The identification of the shipper, except for food imported by international mail • 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 • The anticipated arrival information (location, date, and time) or, if the food is imported by international mail, the U.S. recipient (name and address) • The identification of the importer, owner, and ultimate consignee, except for food imported by international mail or transshipped through the United States • The identification of the carrier and mode of transportation, except for food imported by international mail • Planned shipment information, except for food imported by international mail
Does the carrier need the prior notice confirmation upon arrival? It is prudent to have the confirmation. For a prior notice that is submitted through the ABI/ACS interface, the prior notice confirmation number together with a "PN received" message will be made available to the filer through the ACS/ABI interface. If prior notice is submitted through the FDA PN System Interface, then the transmitter will receive a confirmation online as soon as the submission is confirmed. To make it easier for the carrier or individual at the port, the carrier should have a copy of the confirmation, which includes a prior notice confirmation number in his/her possession. For international mail packages, the Prior Notice Confirmation Number must accompany the package. For food carried by or otherwise accompanying an individual arriving in the United States, the Prior Notice Confirmation Number must accompany the food.
Can an incomplete prior notice be corrected? Yes. If the transmission fails the validation, it will be rejected and the transmitter will have an opportunity to make corrections. The FDA PN System Interface has Help features and interactive feedback to assist the submitter and minimize spelling mistakes and omissions. In addition, the online Help Desk will be available to assist users, beginning December 12, 2003. The Help Desk will be staffed on business days from 7 AM until 11 PM U.S. Eastern Time. Confirmation means the information has been received and is facially complete. Subsequent system and manual review by FDA staff may result in inspection of the imported food upon arrival.
What must be done if information changes after prior notice confirmation has been received? If any of the following required information changes after confirmation, then a new prior notice must be submitted: • Identification of the submitter, including name, telephone and fax numbers, email address, and firm name and address • Identification of the transmitter (if different from the submitter), including name, telephone and fax numbers, email address, and firm name and address • Entry type and CBP identifier • The identification of the article of food, except the estimated quantity • The identification of the manufacturer • The identification of the grower, if known • The FDA Country of Production • The identification of the shipper • The country from which the article of food is shipped or, for food imported by international mail, the anticipated date of mailing • The U.S. recipient (name and address) if the food is imported by international mail • The identification of the importer, owner, and consignee • The identification of the carrier and mode of transportation • Planned shipment information unless the food will not be imported
Does food that has been refused for inadequate prior notice require any additional information in prior notice? Yes. The prior notice for food that has been refused for inadequate prior notice also must include the port of arrival, the location where the refused food is being held, the date it arrived or will arrive at that location, and the identification of the contact person at that location.
What are the consequences of failing to submit adequate prior notice information of an imported food shipment? Food that is imported or offered for import with inadequate prior notice is subject to refusal and holding at the port or in secure storage. FDA will provide its staff with enforcement guidance containing the Agency's policies on injunctions, prosecution, and debarment related to failure to provide timely and accurate prior notice, as well as the Agency's policies regarding refusals under � 801(m)(1) and holds under � 801(l). FDA intends to include a transition period in this guidance, during which it will emphasize education to achieve compliance. While FDA will nonetheless be authorized to take various types of enforcement action for violations of the prior notice requirements, this planned transition period will allow FDA to focus its resources on the most appropriate circumstances. FDA also intends to provide guidance to its staff on enforcing the prior notice requirements after a transition period. FDA's guidance documents will be available to the public, and FDA will publish a notice of availability in the Federal Register.
