Enhancing Food Safety The Role of the Food and Drug Administration (2010) / Chapter Skim
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Appendix E: The U.S. Food and Drug Administration and Imported Food Safety
Appendix E: The U.S. Food and Drug Administration and Imported Food Safety
Pages 451-492
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From page 451... ...
When a foodborne outbreak occurs, the FDA and states can investigate quickly and usually track down the source. Imported foods come to the United States from nearly 200 countries, none of which have exactly the same pesticide, food additive, and veterinary drug approval systems as the United States, and many of which do not have such systems at all.
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From page 452... ...
Nevertheless, many exporting countries that lack domestic food safety programs are willing to do what they can to ensure export markets for their products, including employing food safety measures to satisfy importing country requirements if doing otherwise could cause problems or a loss of market access. While no importing country is able to examine all imported foods for all possible chemical residues and contaminants, microbiological pathogens, and physical hazards, many importing countries have achieved excellent imported food safety records by focusing resources on higher-risk foods and preventive mechanisms and confronting food-related public health problems when they occur.
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From page 453... ...
. The differences between other FDA programs and the foods program are especially apparent in light of the special challenges inherent in regulating imported food safety.
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From page 454... ...
Clearly, the FDA's imported food program needs a fresh review. The Concept and Design for the FDA's Imported Food Program In large part, the FDA's food laws and programs were built around a domestic food industry.
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From page 455... ...
Until very recently, the FDA approached food imports with a philosophy similar to that of its domestic program. All foods, whether domestic or imported, must comply with the same food safety standards, and, as with domestic foods, it is the responsibility of foreign companies -- growers, manufacturers, packers, warehouses -- and importers to know and comply with applicable laws and regulations.
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From page 456... ...
. The procedures for the FDA's handling of imported foods are found in the FDA's Inestigations Operations Manual, Chapter 6, "Imports" (FDA, 2009c)
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From page 457... ...
Food and Drug Administration (FDA) to examine imported food and related documents.
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From page 458... ...
The remittance by the owner or consignee must be to CBP, not to FDA district offices. CBP will issue a demand for redelivery at the request of the FDA.
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From page 459... ...
The affected country may correct the immediate problem, but rarely does the message reach other countries to have a deterrent effect. Because of these and other differences between the FDA's domestic and imported food programs, the agency faces more challenges in regulating imported foods in many respects.
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From page 460... ...
The FDA does not routinely check food products being exported from the United States. OTHER FEDERAL AGENCIES' APPROACHES TO REGULATING IMPORTED FOODS Several agencies have responsibilities in regulating various aspects of the importation of food.
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From page 461... ...
Instead, the FDA turned its full attention to working within the Codex Alimentarius process on the preparation of the Codex guidance on equivalence (Guidelines on the Judgment of Equialence of Sanitary Measures Associated with Food Inspection and Certification Systems, CAC/GL 53-2003, www.codexalimentarius. net/download/standards/10047/CXG_053e.pdf)
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From page 462... ...
ROLES OF STATES IN REGULATING FOOD IMPORTS AND ExPORTS As a general rule, states have been responsible for regulating foods in intrastate commerce, while the FDA's authority focuses on foods in interstate commerce, which include foods moving in international commerce to or from the United States. Thus, states have not had a significant role in regulating imported foods, except those already in domestic commerce.
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From page 463... ...
In these cases, results have been shared with the FDA. Recently, the FDA and the states have been considering giving state inspectors a larger role in dealing with imported foods.8 While not a food import issue per se, it should be noted that virtually all states issue export certificates for food and other products produced in the state.
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From page 464... ...
. It should be noted that Canadian provinces play a large role in ensuring the safety of food products within their jurisdictions, but not in the regulation of food imports/exports.
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From page 465... ...
Simply described, the European Commission (in which food falls under the Directorate General for Health and Consumers, also known as DG SANCO) ensures that food safety legislation established by the Council of the European Union (Council)
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. Australia and New zealand Australia's Imported Food Inspection Scheme is run jointly by the Australian Quarantine and Inspection Service (AQIS)
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From page 467... ...
Australia rarely requires export certificates. The exception is when the certificate requirement is being used as a tool to deal with a specific problem.
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The SPS Agreement specifically recognizes the Codex Alimentarius Commission (WTO, 1995)
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From page 469... ...
negotiating team for the Uruguay Round negotiations, especially on the SPS negotiations. The eventual text provided a balance between preserving a country's sovereign right to protect its citizens from public health hazards in imported food (among other things)
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From page 470... ...
Sanitary measures that conform to international standards, guidelines, or recommendations are deemed necessary to protect life or health and are presumed to be consistent with the SPS Agreement and GATT 1994. Thus, Codex standards become a "safe harbor" in the event of a challenge under the SPS Agreement.
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From page 471... ...
Teamwork, Clear Objectives, and Consonant Implementation Because a number of offices in FDA headquarters and the field take part in establishing the objectives of the imported food program, it is important
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From page 472... ...
Too often there have been conflicts in priorities or misunderstandings regarding program objectives that have hampered optimal achievement of these objectives. For example, despite the FDA's goal of protecting public health from unsafe residues of pesticides in imported foods, the parallel goal of detecting as many violative shipments as possible led field offices in the past to oversample imported spices that often had violative residues.
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From page 473... ...
Although the public health importance of pesticide residues in the food supply has diminished -- partly because of new, more protective pesticide legislation -- the FDA's teamwork in giving this program the coordination needed at the time helped EPA and Congress obtain the data and knowledge required to develop the much-needed legislation. Potential Use of Third-Party Certification As the FDA's imported food program encounters a vast variety of foods from a broad spectrum of countries, companies, and importers, the challenges in ensuring imported food safety are considerable.
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From page 474... ...
. Incentives to Export Safe Food There are a number of ways to encourage foreign companies to export safe food that could be incorporated into the FDA's imported food program.
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. The Prior Notice Center can decide to detain the shipment based on terrorism criteria or can release the entry line back into PREDICT admissibility screening.
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NOTE: FDA = U.S. Food and Drug Administration, OASIS = Operational and Administrative System for Import Support, PN = prior notice, PREDICT = Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting.
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From page 477... ...
To correct this problem, there are plans to utilize a unique, reproducible identifier for each facility. Nevertheless, importers will need to work closely with filers to ensure data quality, as poor-quality or missing data will increase the risk scores for entry lines.
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From page 478... ...
improving response and recovery. Although the FSWG's initial key findings say little that pertain to the FDA's imported food program, it is understood that the full report, yet to be released, may contain such recommendations.
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From page 479... ...
pertaining to imported foods have, according to FDA contacts, been incorporated or addressed in the FSWG report, although until the full report is released by the White House, this cannot be confirmed. Food Safety Legislation Several pieces of food safety legislation have been proposed in the current Congress, including S510, HR875, HR759, and HR1332.
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From page 480... ...
The Secretary of HHS will determine for which foods mandatory standards/GAPs are necessary. Records access -- Each person who manufactures, processes, packs, • or holds an article of food in the United States or for importation into the United States must give inspectors access to records, includ ing the food safety plan.
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From page 481... ...
for nonprocessed food, if the country of origin of the food is not given. Export certificates -- While not part of the import program, CFSAN • currently issues thousands of official export certificates annually since some countries demand such certificates as a condition for entry of imported foods.
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From page 482... ...
and participation in the safe and secure food importation program under section 805. Registration can be suspended or cancelled so that the importer has an incentive to follow the rules and not allow the firms it represents to skirt current regulatory sanctions.
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From page 483... ...
and report back on regulatory and other best-practice tools that might be added to the FDA's existing mechanisms for ensuring the safety of imported foods. Open up for input, publicize, and promote the FDA's imported • food program, its elements, its goals, and its accomplishments.
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From page 484... ...
HR2749 also establishes fees for registration that should help support the FDA's imported food program. Give priority to negotiating agreements with countries including, • but not limited to, those having comparable food safety systems for which products could be examined/sampled at a low frequency.
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From page 485... ...
Consider limiting ports of entry for FDA products, ensuring that • the FDA has adequate staff to cover all ports of entry. Entry points for imported foods number in the hundreds.
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From page 486... ...
HR2749 requires fees for registration of both domestic and foreign firms, thus providing a portion of the support for the imported food program, albeit pay ing for the registration rather than the services themselves. Develop a policy statement(s)
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From page 487... ...
Utiliz ing surveillance sampling solely for information gathering would free up laboratory and inspectional resources that could be utilized to examine/sample a greater percentage of imported foods, pro viding improved protection of consumers. If violations are found, future shipments of the same food can be stopped, and, of course, follow-up on the initially sampled shipment is warranted if there is a significant acute health concern.
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From page 488... ...
Establish more direct line authority and/or performance metrics • between CFSAN and ORA headquarters and field staff conducting the imported food program. CFSAN establishes food programs and policies, but often must compromise on the optimal imple mentation of its programs because of the ORA operational culture and organization, which cover both medical products and foods.
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2008. Imported Food Fees.
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From page 490... ...
2009d. Prior Notice of Imported Foods.
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From page 491... ...
2008. Import Process, Prior Notice, and Import Alerts.
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