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| Agenda Item 4.5 | GF 02/8b |
second fao/who global forum of food safety regulators
Bangkok, Thailand, 12-14 October 2004
(Prepared by the United States of America)
With the proliferation of movement of people, food and agricultural products between countries, food produced in one country increasingly ends up on the dinner table in another. This process is accelerating and expanding, evidenced and hastened by the multitude of cooperative relationships being pursued and established among countries.
Within the United States of America (U.S.A.), two Federal agencies have the primary responsibility for assuring the safety of imported foods. The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) enforces laws and regulations relating to meat, poultry, and egg products. The U.S. Food and Drug Administration within the Department of Health and Human Services (HHS/FDA) enforces the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws which provide jurisdiction over all other foods. Both agencies are charged with protecting the health of consumers and assuring truthful labeling for the foods under their authority.
All food products imported into the U.S.A. are required to meet the same standards as domestic goods. To enter the U.S.A., imported foods must be pure, wholesome, safe to eat, produced under sanitary conditions, and must meet all U.S. standards including having informative and truthful labeling in English.
Due to differences in the attributes of products falling under their respective jurisdictions, the differences in the historical development of the agencies and in their underlying legal authorities, USDA/FSIS and HHS/FDA take different approaches to the regulation of food, including imported food products.
Countries that export meat, poultry and egg products to the U.S.A. must have an inspection system equivalent to the U.S. system. Foreign countries undergo a comprehensive review process before they may be considered eligible to export to the U.S.A.. To ensure equivalency, FSIS works collaboratively with the inspection service of the exporting government. While the meat, poultry and egg product regulatory systems of other countries need not be identical to the FSIS system, they must employ equivalent measures considered to provide the same level of protection against food safety hazards. FSIS makes two types of equivalence determinations: (1) determinations of initial equivalence (termed "eligibility") for countries that are not yet trading partners, and (2) determinations of whether equivalence is being maintained by countries already eligible.
The evaluation of a country's inspection system to determine initial eligibility entails a document review and an on-site audit. Through the document review, an evaluation is conducted of the country's laws, regulations and other written information detailing its controls in five risk areas: sanitation, animal disease, slaughter and processing, residue and enforcement. If the document review process yields an affirmative equivalency determination, a technical team will visit the country to make an on-site evaluation of the five risk areas, in addition to other aspects of the inspection system. This initial equivalency audit includes plant facilities and equipment, laboratories, training programs and in-plant inspection operations. Such on-site audits are intended to verify that countries have implemented inspection programs properly and, if not, to resolve differences and clarify requirements.
Once equivalence has been established, the foreign country is eligible to ship products to the U.S.A.. It is important to note that FSIS does not conduct food inspections in other countries, nor does it certify individual foreign establishments for export to the U.S.A.. After it is determined that a country has an equivalent food regulatory system, FSIS will rely on that system to carry out daily inspection and to certify individual exporting establishments.
To verify on-going equivalence, FSIS regularly conducts on-site audits of the eligible foreign inspection systems and re-inspection of products upon arrival in U.S. ports. The term re-inspection is used because, due to the FSIS equivalence requirement, all entering products have been inspected and approved by the exporting country’s equivalent inspection system.
As a general matter, all products enter the country under the authority of U.S. Customs and Border Protection (CBP), Department of Homeland Security. Importers of any merchandise into the U.S.A. must file an entry form with CBP within five working days following the arrival of the shipment at a U.S. port-of-entry. For meat and poultry shipments, FSIS requires two additional documents--the original certificate from the country of origin indicating that the product was inspected and passed by the country's inspection service and is eligible for export to the U.S.A., along with an import inspection application and report. The CBP also requires the importer to post a bond, usually of an amount to cover the value of the shipment plus duties and fees. As a result, meat and poultry shipments remain under bond and subject to recall by the CBP until FSIS re-inspection occurs and the product is cleared for release.
Once the necessary documentation is provided, every shipment is given a visual inspection for appearance and condition and is checked for certification and label compliance. In addition, a centralized system linking all inspection activities, the Automated Import Information System (AIIS), assigns to import inspectors other types of inspection. These include product examinations and laboratory analyses for microbiological contamination and chemical residues. These testing programs are modeled after the microbial residue testing plans for domestic products in the U.S.A..
If the shipment fails the re-inspection, it is refused entry by FSIS; and the frequency of inspection is increased for shipments of similar product from the same foreign establishment until a record of compliance is re-established.
When a shipment is refused entry to the U.S.A., the importer has several options. The shipment can be re-exported from the country, destroyed, or, in some cases, converted to animal food. In addition, importers are permitted to re-label products to bring them into compliance with U.S. requirements.
HHS/FDA regulates all foods (e.g. seafood, fruits and vegetables, dairy products) except meat, poultry, and certain egg products. To ensure that HHS/FDA is notified of all regulated products imported into the U.S.A., the importer, or his/her representative, must file an entry notice and an entry bond with the CBP, pending a decision regarding the admissibility of the product. HHS/FDA inspection and enforcement procedures for imports are closely coordinated with CBP.
HHS/FDA receives notification of all HHS/FDA-regulated entries through CBP. If HHS/FDA does not wish to examine the entry, the product is allowed to proceed into U.S. commerce. Any time a sample of an article offered for import has been requested by the HHS/FDA for testing, the owner or consignee shall hold the shipment and not distribute it until further notice is received regarding the results of the examination of the sample.
Generally, if HHS/FDA decides to examine an entry, an HHS/FDA investigator or inspector will collect a sample from the shipment for laboratory evaluation. If the analysis indicates the product is in compliance, the shipment may be released into U.S. commerce.
If, after HHS/FDA examination, it appears that the product is in violation, HHS/FDA issues a Notice of Detention and Hearing to the owner or consignee of the article, specifying a place and period of time whereby the individual may introduce testimony either verbally or in writing. Depending upon the nature of the apparent violation of the FD&C Act, the importer may be provided an opportunity to submit a petition to recondition the product to bring it into compliance. The owner or consignee may submit an application to HHS/FDA to re-label or perform other actions to bring the article into compliance or render the article into something that is not a food, drug, device, or cosmetic. An application for authorization to re-label or perform other actions to bring the article into compliance shall contain a detailed proposal, specifying the time and place where such operations will be carried out and the approximate time for completion as specified by regulation. All petitions to recondition a product are subject to HHS/FDA review and approval.
The FD&C Act, Section 801(a) provides for refusal of admission of any article that appears to be in violation of the Act. If the product is not brought into compliance and is refused admission, the importer is required to either re-export or destroy the article under CBP or other approved supervision within 90 days of the date of the issuance of the refusal. If the refused product is not destroyed or re-exported as required, CBP issues a notice for redelivery to the importer of record. Failure to redeliver the refused product may result in CBP assessing liquidated damages against the importer's bond.
In some instances a Notice of Detention and Hearing is issued for a product as soon as it is offered for entry into the U.S.A. without physical examination, based on past history and/or other information indicating the product may be in violation. A product may be subject to a detention without physical examination (DWPE) recommendation until the shipper, manufacturer or importer demonstrates the product meets HHS/FDA guidelines or standards.
Occasionally, HHS/FDA identifies products from an entire country or geographic region for DWPE when the violative conditions appear to be geographically widespread. Detention recommendations of this breadth are rare and usually are initiated when there are no other avenues for resolving the problem.
In addition to required import entry forms, certain products should be accompanied by the submission of additional information to facilitate processing and to assure compliance with applicable HHS/FDA regulations. For example, foreign manufacturers of low-acid or acidified low-acid canned foods (LACF) must register and file processing information before shipping their product to the U.S.A.. Providing HHS/FDA with the Food Canning Establishment (FCE) number of the manufacturing site as well as the Scheduled Process Identification (SID) number at the time of entry is strongly recommended.
To assure the expeditious handling of imported products, HHS/FDA has automated its import operations. By combining HHS/FDA's Operational and Administrative System for Import Support (OASIS) and CBP’s Automated Commercial System (ACS), a HHS/FDA reviewer is able to more efficiently evaluate and process each import entry. The import filer transmits the required shipment-specific HHS/FDA data into the ACS. Within several minutes, the filer is notified that either the shipment has been released or HHS/FDA wishes to review it. This system provides HHS/FDA with immediate data on imported products, provides information on potential problems, and maintains national historical data files to develop profiles on specific products, shippers, manufacturers and importers.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) requires that HHS/FDA receive prior notice of food imported into the U.S.A., beginning on December 12, 2003. HHS/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 (ABI) of the ACS, and the rest by using HHS/FDA’s Prior Notice System Interface (PNSI). Most of the prior notice information required by the interim final rule is data usually provided by importers or brokers to CBP when foods arrive in the U.S.A.. Now, the Bioterrorism Act requires that this information also be provided to HHS/FDA in advance of an imported food's arrival to the U.S.A.. HHS/FDA uses this advance information to determine whether to inspect the imported food. Failure to comply with prior notice requirements may result in refusal of the food. If refused, food must be held and cannot be shipped to the importer, owner, or consignee until prior notice requirements have been met.
Unlike FSIS, HHS/FDA does not require that countries exporting food to the U.S.A. supply certificates attesting to compliance with U.S. food safety laws and regulations. The HHS/FDA operates with the expectation that U.S. and foreign food producers and manufacturers will comply with U.S. safety requirements for the product in question, whether imported or produced domestically. Products found to pose a safety hazard or appearing to pose such a hazard, based on reliable information (e.g., testing of previous shipments of the food) are subject to refusal. Similarly, products that are not in compliance with U.S. labeling requirements and are thus “misbranded” also are subject to refusal.
Food products under HHS/FDA’s jurisdiction that are entering the U.S.A. need not be covered by an equivalence determination. Although a country may seek an equivalence determination from the U.S., generally such a determination would confer small, if any, advantage in providing greater access to the U.S. market. Nor do food products under HHS/FDA’s jurisdiction need to be accompanied by a certificate from the exporting country attesting to the safety of the product or compliance with U.S. requirements. Although certificates are not required for entry of HHS/FDA-regulated food products, HHS/FDA examines and tests the foods being offered for entry into the U.S.A. for food borne hazards, whether chemical, microbial, or physical. HHS/FDA does require, by regulation, that seafood and juice products be produced under Hazard Analysis Critical Control Point (HACCP) systems, but neither needs export certificates from the government of the exporting country attesting to this fact as a condition for importation.
In the U.S.A., two Federal agencies have the primary responsibility for regulating the import of food products. All food products imported into the U.S.A. are required to meet the same standards as domestic goods, and the historical development of the two regulatory agencies and their underlying legal authorities has led them to take different approaches to the regulation of imported food products.
Meat and poultry imports, regulated by FSIS, must originate from countries and facilities judged to have equivalent inspection systems to the U.S.A. and, thus, eligible to export to the U.S.A.. HHS/FDA, which regulates all other food products, operates with the expectation that the foreign food producers and manufacturers will comply with U.S. safety requirements. If foods are not in compliance with U.S. requirements and present a public health hazard, both Agencies will take swift and firm regulatory action to assure that such foods do not reach the U.S. consumer.
The Forum may wish to consider the following points regarding food import/export control and certification systems.