*EPF507 08/22/2003
Text: Food and Drug Administration Proposing Tougher Food Import Rules
(Would require certain food facilities to register with agency) (2160)
The U.S. Food and Drug Administration (FDA) is proposing that foreign and domestic facilities that manufacture, process, pack or hold food to be consumed by humans or animals in the United States be required to register with the agency.
FDA also wants to be given prior notice before food is imported or offered for import into the United States, according to an August 22 press release.
The proposed rules, mandated by the Bioterrorism Act of 2002, are expected to go into effect December 12. The agency said it is currently reviewing public comments on the proposals.
Another rule would require specific records about a food's "immediate previous sources and immediate subsequent recipients" to be kept and retained. A fourth rule would identify procedures the secretary of Health and Human Services, through FDA, would take to stop foods "that present a serious health threat to humans or animals" from entering the U.S. food system.
FDA is proposing that certain facilities -- including restaurants, non-processing fishing vessels and facilities regulated exclusively by the U.S. Department of Agriculture -- be exempt from the rules.
Businesses with 500 employees or more would have six months to comply with the final regulations after publication in the Federal Register, the release said. Smaller businesses would have 12 or 18 months to comply, depending on their size.
The agency said it expects the final registration requirements will be published by mid-October to allow the food industry time to understand the new requirements and comply by December 12, the date specified by Congress.
Following is the text of FDA's press release:
(begin text)
August 22, 2003
New FDA Rules Under the Bioterrorism Act Will Require Action by Many in the Food Industry
Many facilities and individuals engaged in the production, importation and distribution of food will have to meet new requirements from the FDA beginning December 12, 2003. Mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), one of these new regulations would require registration of domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. Another would require prior notice to FDA of food imported or offered for import into the U.S. A third regulation would specify information that must be included and retained in records that would identify the immediate previous sources and immediate subsequent recipients of food. Lastly a fourth regulation identifies procedures under which FDA would administratively detain food that presents a serious health threat to humans or animals.
Following the events of September 11, 2001, Congress passed the Bioterrorism Act to strengthen U.S. security against bioterrorism. The act provides several new tools that enable FDA to act quickly in responding to threatened or actual terrorist attacks on the U.S. food supply or other food-related emergencies by providing the agency with better information than is now available to the agency about the production and distribution of food consumed in, or entering, the U.S. FDA published the new regulations as proposals for comment and currently is evaluating the comments it received. FDA plans to publish the final registration and prior notice regulations by mid-October 2003, to allow the food industry time to understand the new requirements and be in compliance by the date Congress specified in the Bioterrorism Act, December 12, 2003. The agency plans to publish the final record-keeping and administrative detention rules by December 12, 2003.
Note: This information reflects the new regulations as they were proposed for public comment. The comments FDA received likely will alter some details in the final regulations, which will contain the requirements with which affected industry must comply.
Registration of Food Facilities
Domestic or foreign facilities that manufacture, process, pack or hold food for consumption by humans or animals in the U.S. will have to register with FDA no later than December 12, 2003. Registrations will not be accepted until the final regulation is published. At that time, the owner, operator, or agent in charge of a domestic or foreign facility will be able to register via the internet to submit required information -- e.g., the name and address of each facility at which the registrant conducts business and the categories of food the facility handles -- and receive from FDA an instantaneous confirmation of registration and the facility's registration number. Registrations by mail also will be accepted, but that will be a much slower process. There is no fee associated with registration. Imported food from foreign facilities that are required to register but have not will be held at the port of entry until the facility is registered. In addition, it is a prohibited act to fail to register if required to do so, which could subject the owner, operator, or agent-in-charge of the facility to criminal or civil penalties.
Except for the exemptions below, the new requirement would apply to all affected facilities for all foods and animal feed products regulated by FDA, including dietary supplements, infant formula, beverages (including alcoholic beverages), and food additives.
Exemptions: farms, restaurants, retail food establishments, non-profit establishments that prepare or serve food, fishing vessels not engaged in processing, facilities regulated exclusively by the U.S. Department of Agriculture, and foreign facilities, if the food from the facility undergoes significant further processing or packaging by another facility outside the U.S.
Prior Notice of Imported Food
Beginning on December 12, 2003, FDA must receive advance notice of each article of food imported or offered for import into the U.S. --- regardless of whether the food will be consumed in the U.S. The proposed rule would require notice to be submitted by noon the day before the food arrives at the port of entry. Among other items, the notice must include a description of the food, the manufacturer and shipper, originating country, country from which the article is shipped, and anticipated port of entry. FDA and the Bureau of Customs and Border Protection (CBP) have announced that importers, in most circumstances, will be able to provide the required prior notice information to FDA using CBP's automated commercial system, which currently is used to provide import information to customs, making it easier for them to comply with the new law.
If prior notice is not submitted or is inadequate, the act provides that the food shall be held at the port of entry until adequate notice is provided.
Exemptions: food brought into the U.S. in a traveler's personal baggage.
Establishment and Maintenance of Records
Domestic persons that manufacture, process, pack, transport, distribute, receive, hold, or import food for consumption in the U.S. will be required to create and maintain records that are necessary to identify the immediate previous sources and the immediate subsequent recipients of food (i.e., where it came from and where it went). This requirement also applies to foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. The information will allow FDA to follow up on credible threats of serious illness or death to humans or animals by tracing the food back to its source, and tracing the food forward to all recipients to remove it from commerce as necessary.
Larger businesses (more than 500 employees) would have to comply with the final regulation within 6 months from its publication in the Federal Register. Small businesses (fewer than 500 but more than 10 full-time equivalent employees) would have to comply within 12 months from publication, and very small businesses (10 or fewer full-time equivalent employees) would have to comply within 18 months from publication.
Exemptions: farms, restaurants, certain pet food entities, retail food establishments, non-profit establishments that prepare or serve food, fishing vessels not engaged in processing, facilities regulated exclusively by the U.S. Department of Agriculture, and foreign facilities, if the food from the facility undergoes significant further processing or packaging by another facility outside of the U.S. retail food operations also are exempted from maintaining records on immediate subsequent recipients when food is sold directly to consumers.
See FDA's web page on the Bioterrorism Act. It includes the act itself, the provisions related to FDA, and the agency's regulatory proposals and activities to implement these provisions. Find it at: http://www/FDA.gov/oc/bioterrorism/bioact.html.
Background
President Bush signed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, P.L. 107-188, into law on June 12, 2002. A full copy of the Act is available at
The Secretary of HHS, through the FDA, is required to propose and issue final regulations for the following four food-related provisions in Title III of the act:
A. Section 305 (Registration of Food Facilities) -- requires the owner, operator, or agent in charge of a domestic or foreign facility to register with the FDA no later than December 12, 2003. Facilities are defined as any factory, warehouse, or establishment, including importers. The Secretary, through FDA, is required to issue final regulations addressing the registration requirements no later than December 12, 2003; however, food facilities must register with FDA by this date even if FDA has not issued final regulations. FDA expects to issue final regulations at least one month before this deadline. The Bioterrorism Act exempts farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer; and fishing vessels (except such vessels engaged in processing as defined in 21 CFR 123.3(k)) from the requirement to register. Also, foreign facilities subject to the registration requirement are limited to those that manufacture, process, pack, distribute, receive, hold or export food, only if food from such facility is exported to the United States without further processing or packaging outside the united states.
B. Section 307 (Prior Notice of Imported Food Shipments) requires that prior notice of food shipments be given to FDA. The notice must include a description of the article, the manufacturer and shipper, the grower (if known), the country of origin, the country from which the article is shipped, and the anticipated port of entry. The Secretary, through FDA, must issue final regulations by December 12, 2003. While FDA fully expects regulations to be issued by this date, if such regulations are not issued, the statute still requires importers to provide no less than 8 hours and no more than 5 days notice to FDA until the regulation takes effect.
C. Section 306 (Establishment and Maintenance of Records) requires the Secretary, through FDA, to issue final regulations by December 12, 2003, to establish requirements for the creation and maintenance of records needed to determine the immediate previous sources and the immediate subsequent recipients of food, (i.e., one up, one down). Such records are to allow FDA to address credible threats of serious adverse health consequences or death to humans or animals. Entities subject to these provisions are those that manufacture, process, pack, distribute, transport, receive, hold or export food for consumption by humans or animals in the United States. Farms and restaurants are exempt from these requirements.
D. Section 303 (Administrative Detention) authorizes the Secretary, through FDA, to order the detention of food if an officer or qualified employee finds credible evidence or information indicating an article presents a threat of serious adverse health consequences or death to humans or animals. The Bioterrorism Act requires the Secretary, through FDA, to issue final regulations to expedite court actions on perishable foods. No time frame is specified.
Except for the specified exemptions, these new regulations will apply to all facilities for all food and animal feed products regulated by FDA, including dietary supplements, infant formula, beverages (including alcoholic beverages) and food additives. FDA regulates all foods except meat, poultry and processed egg products, which are regulated by the U.S. Department of Agriculture.
FDA has prepared materials summarizing the development of these two regulations, including specifics on how to comment, and has provided copies of these materials to posts on CD. The materials will also be available on the FDA Bioterrorism Act web site identified in paragraph 6 above.
(end text)
(Distributed by the Bureau of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)
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