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Appendix E
The U.S. Food and Drug Administration and Imported Food Safety1,2

In the United States, an apple grower knows what pesticides the U.S. Environmental Protection Agency (EPA) has approved for use in apples, their application rates, and preharvest intervals. Similarly, a dairy farmer and his/her veterinarian can look at a U.S. Food and Drug Administration (FDA)-approved label on an FDA-approved veterinary drug and know whether the drug can safely be used in cows producing milk and for how long the milk must be discarded. Domestic food manufacturers, food warehouses, and farms recognize that they can be inspected and their products sampled. Domestic producers worry about maintaining the integrity and good reputations of their brands. U.S. trade organizations educate their members about food safety and FDA regulations. 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. Foreign producers may be ignorant of U.S. food safety requirements or may produce for multiple foreign markets.

1

Catherine Carnevale, V.M.D., Retired, FDA; former Director of International Affairs at the FDA Center for Food Safety and Applied Nutrition and lead U.S. Delegate to the Codex Alimentarius Committee on Food Import/Export Inspection and Certification Systems.

2

Because of the broad scope of this appendix, laws, regulations, proposed legislation, trade agreements, guidance, activities, and issues have been summarized and paraphrased for the sake of brevity. A few topics are discussed in detail based on specific requests of the committee and staff, but most are not. Thus, the discussion is not meant to be comprehensive.



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Appendix E The U.S. Food and Drug Administration and Imported Food Safety 1,2 I n the United States, an apple grower knows what pesticides the U.S. Environmental Protection Agency (EPA) has approved for use in apples, their application rates, and preharvest intervals. Similarly, a dairy farmer and his/her veterinarian can look at a U.S. Food and Drug Administration (FDA)-approved label on an FDA-approved veterinary drug and know whether the drug can safely be used in cows producing milk and for how long the milk must be discarded. Domestic food manufacturers, food ware- houses, and farms recognize that they can be inspected and their products sampled. Domestic producers worry about maintaining the integrity and good reputations of their brands. U.S. trade organizations educate their members about food safety and FDA regulations. When a foodborne out- break 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 veteri- nary drug approval systems as the United States, and many of which do not have such systems at all. Foreign producers may be ignorant of U.S. food safety requirements or may produce for multiple foreign markets. 1 Catherine Carnevale, V.M.D., Retired, FDA; former Director of International Affairs at the FDA Center for Food Safety and Applied Nutrition and lead U.S. Delegate to the Codex Alimentarius Committee on Food Import/Export Inspection and Certification Systems. 2 Because of the broad scope of this appendix, laws, regulations, proposed legislation, trade agreements, guidance, activities, and issues have been summarized and paraphrased for the sake of brevity. A few topics are discussed in detail based on specific requests of the committee and staff, but most are not. Thus, the discussion is not meant to be comprehensive. 

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 ENHANCING FOOD SAFETY Domestic food safety systems in exporting countries may vary from excel- lent to nonexistent. Potable water may not be available for irrigation; waste and sewage treatment may be absent or inadequate. 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. As discussed in this appendix, import programs for food safety can employ many methodologies to foster safer imports and provide incentives for foreign producers/food importers to comply with importing country requirements. Just as imported food presents different food safety challenges from those encountered with domestically produced foods, so, too, do they require a different paradigm for regulation. BACKGROUND The FDA’s overall foods program is distinct in several respects from the agency’s other public health regulatory program areas. First—with the exception of food and color additive approvals and premarket notification for certain foods—foods under FDA jurisdiction, whether produced within or outside the United States, do not require premarket approval. Thus, the foods program overall is generally a postmarket program. A second differ- ence is that the foods regulatory program, to date, is not supported in any way by user fees, while all agency premarket approval programs are, as well as all agency export certificate programs, except for foods. Thus the foods program, at present, is totally dependent on congressional appropriations. Third, whereas most of the FDA’s other centers generally have regulatory autonomy over their respective product areas, the Center for Food Safety and Applied Nutrition (CFSAN) must interface with other federal depart- ments and agencies, as well as the 50 states, to ensure consistent and com- prehensive coverage of the entire U.S. food supply at all levels. While the regulatory roles of U.S. food safety partners are well delineated, smooth operation of the U.S. food control system requires constant communication to ensure that the roles mesh efficiently. Finally, the foods program differs from other FDA programs in that, by volume of product and number of consignments, the realm for regulatory oversight is vast. These four differ- ences are important to remember and fundamental in considering potential improvements in the FDA’s foods program because one needs to understand

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 APPENDIX E Animal Drugs and Feeds 254, 1% Cosmetics 1,700, 9% Devices and Radiological Health 6,800, 36% Foods 9,500, 52% Human Drugs 330, 2% Biologics 81, 0% FIGURE E-1 Fiscal year 2009 estimated import lines by program area (in thou- sands): total 18.7 million lines. SOURCE: Personal communication, Steven Solomon, Office of Regulatory Affairs, July 2009. Figure E-1 R01720 color, portrait size the regulatory context in which the program operates in regulating 80 per- redrawn as editable vectors cent of the nation’s food supply (Meadows, 2006). 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. The estimated total of food import entry lines3 for fiscal year (FY) 2009 is 9.5 million, or 52 percent of the estimated total of 18.7 million lines for all FDA-regulated imported products (see Figure E-1).4 Food imports now account for approximately 15 percent of the foods and 80 percent of the seafood consumed in the United States (Acheson and Glavin, 2007). In addition to quantity, the variety of imported product types is chal- lenging to regulate, ranging from highly perishable produce, to dairy, to shellfish, to canned products, to bakery goods. The number and types of countries exporting products to U.S. shores are also wide-ranging, from less developed countries with, at best, rudimentary food regulatory sys- tems to developed economies with highly regarded food safety controls. 3 An entry line is each portion of an import shipment that is listed as a separate item on an entry document. Items in an import entry having different tariff descriptions must be listed separately. 4 Personal communication, Steven Solomon, Office of Regulatory Affairs, FDA, July 2009.

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 ENHANCING FOOD SAFETY Although many countries may have a limited spectrum of products that they export, almost every country exports agricultural commodities, and almost 200 countries export such commodities to the United States (FAS, 2009). Regulating imported foods can be complex. With such foods, the FDA may need to consider not only the exporting country’s food control system but also the environment in which the food is grown, including the avail- ability of potable water for irrigation and washing, and diseases of farm workers and farm animals that could impact the safety of the food. In addi- tion to working with other U.S. food-related agencies and states, as it does for its domestic food safety program, for its imported food program the FDA must interface with U.S. Customs and Border Protection (CBP, in the U.S. Department of Homeland Security), the Office of the U.S. Trade Rep- resentative, the Foreign Agricultural Service, the Departments of State and Commerce, and exporting country governments themselves. Compliance with international trade agreement obligations is important in dealing with imports, including ensuring that the scientific basis for all FDA regulatory measures that may impact trade is clear and no more trade-restrictive than necessary. Imported foods are infrequently examined at the border, often being sampled for analysis less than 1 percent of the time (GAO, 2008).5 There are simply too many imported food shipments for the FDA resources available. Certainly there are too many foreign firms to consider on-site inspections on a routine basis, and the few such inspections performed can only provide a snapshot of a country’s internal food regulatory system. Most foreign facilities that produce, manufacture, process, or store foods consumed in the United States must register under the bioterrorism regula- tions (FDA, 2009a); however, there is no mechanism for putting foreign food producers and shippers on notice that U.S. food safety laws must be followed, other than the laws and regulations themselves. 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. Domestic food facilities were to be inspected, with the FDA focusing on products involved in interstate commerce and states concentrating on retail and intrastate establishments. Sampling of food was conducted during inspections of firms to detect problems or to confirm a safety concern when one was suspected. Sampling of products being moved in commerce was done primarily on a surveillance basis and often close to 5 The FDA examined less than 1 percent of the 7.6 million fresh produce lines imported from FY 2002 through 2007.

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 APPENDIX E the farm gate or boat. Foods were not transported long distances; only a tiny fraction of foods consumed came from other countries, and these were traditional imports such as bananas and coffee. Until very recently, the FDA approached food imports with a philoso- phy 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. The FDA maintains a comprehensive website that provides all this information, generally in English only (FDA, 2009b). Although it can be argued that knowing the food safety require- ments of the importing country should be integral to conducting a food export business, it may also be noted, with some exceptions, that until quite recently the FDA did not actively pursue outreach to foreign countries, their industries, or importers regarding its food safety requirements. The agency has conducted annual meetings with Washington embassies on its programs (in all FDA product areas). It also carried out a massive outreach program on the implementation of its bioterrorism regulations a few years ago through meetings with embassies, World Bank−assisted regional video- conferences, and question/answer sessions at the World Trade Organization (WTO) in Geneva. In the case of meat, poultry, and processed egg products, by law the U.S. Department of Agriculture (USDA) cannot grant market access until the exporting country’s system has been evaluated and determined to be equivalent to the U.S. system in the level of protection provided.6 By contrast, the FDA has seen its job with food imports primarily as one of checking the products at ports of entry. However, the FDA cannot begin to examine the vast number and variety of food shipments arriving at about 300 ports of entry throughout the United States (GAO, 2008). Today, with approximately 15 percent of all foods consumed in the United States being imported, amounting to millions of shipments and hundreds of millions of dollars, the FDA continues to look at as many ship- ments as possible and sample products mainly on a surveillance basis—that is, not “for cause.” Nevertheless, recognizing that its import surveillance resources are limited, the agency has always prioritized food safety sampling in its compliance programs to look for chemical contaminants, microbes, and other problems in specific foods in which such problems are more likely to be found based on historical and available intelligence. 6 For meat: Animal and Animal Products, 9 Code of Federal Regulations (CFR) 327.2; for poultry, Animal and Animal Products, 9 CFR 381.196; for processed egg products, Inspection of Eggs and Egg Products, 9 CFR 590.910.

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 ENHANCING FOOD SAFETY The FDA’s Process for Dealing with Imported Foods The process the FDA follows in examining food import documents and the foods themselves is summarized in Figure E-2 (Veneziano, 2008). The procedures for the FDA’s handling of imported foods are found in the FDA’s Inestigations Operations Manual, Chapter 6, “Imports” (FDA, 2009c). Any article that is offered for entry into the United States and sub- ject to the laws administered by the FDA with a value greater than $2,000 is considered a formal entry. Formal entries require that a bond be filed with CBP; this bond includes a condition for redelivery of the merchandise at any time or, in case of default, the collection of liquidated damages. Notification of the CBP entry is usually accomplished by electronic sub- mission through the CBP Automated Commercial System (ACS). The FDA reviews the entry documents electronically through the FDA/ACS interface and decides whether the shipment may proceed into U.S. commerce or should be examined further. The FDA also reviews informal entries and, if it decides to take action on such an entry, asks CBP to convert it into a formal consumption entry. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires that domestic and foreign facili- ties that manufacture, process, pack, or hold food for human or animal consumption in the United States register with the FDA (FDA, 2009a). The Bioterrorism Act also requires that the FDA receive advance notice of food to be imported into the United States before the food arrives—called prior notice (FDA, 2009d). The information required for prior notice to the FDA is basically the same as that usually required by CBP. Prior notices can be submitted either through the Automated Broker Interface/ACS or the FDA’s Prior Notice System Interface. Products being transported by road require 2 hours prior notice, those being transported by rail or air 4 hours notice, and those by water 8 hours. As a rule, prior notice must be given for all foods under FDA jurisdiction, with the exception of foods made by indi- viduals as a gift or food carried with a traveler for personal consumption or consumption by family or friends. 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. The FDA’s Prior Notice Center, operating 24 hours a day, 7 days a week, reviews the prior notices received. The review process is designed to identify food products that may pose serious risks to public health under the Bioterrorism Act so that appropriate action can be taken when the food arrives at the port of entry. If the food meets the prior notice requirements, the FDA’s Operational and Administrative System for Import Support (OASIS) data system review (discussed later in the section on Predictive Risk-Based Evaluation for Dynamic Import Compliance Target-

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landscape below (assuming a very shor t caption) editable vectors DOCUMENT REQUEST/INFORMATION DATA DATA DATA ACS/ PRIOR CHB (CHB)/FILER ABI SOFTWARE NOTICE IMPORTER ENTRY REVIEW OASIS EXAMINE DISCLAIMER • LABEL FDA HOLD • CONTAINER INTEGRITY • SAMPLING • VERIFICATION MAY PROCEED RECOMMEND LAB DETENTION DATA LAB DATA REPORT COMPLIANCE DATA OFFICER NOTICE OF DETENTION TIME-“TESTIMONY” U.S. MORE INFO COMMERCE RELEASE REFUSED SYSTEM U.S. CUSTOMS SERVICE EXPORT DESTRUCT FIGURE E-2 Process used by the U.S. Food and Drug Administration (FDA) to examine imported food and related documents. NOTE: ABI = Automated Broker Interface; ACS = Automated Commercial System; CHB = Customs House Broker; OASIS = Op-  erational and Administrative System for Import Support.

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 ENHANCING FOOD SAFETY ing [PREDICT]) determines whether further evaluation of the shipment is necessary under section 801(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) before the food can enter U.S. commerce. For example, if a particular product falls under an FDA import alert, OASIS may flag the shipment for detention without physical examination (DWPE). The food may also be flagged for sampling or examination under a CFSAN compli- ance program or sampling assignment. In addition, an FDA reviewer may decide to examine a product (e.g., to check its labeling or the integrity of cans) or collect samples for analysis in an FDA laboratory. If a product arrives at a point of entry where an FDA official is not expected to be present, the responsible FDA district office may ask CBP to collect a sample for forwarding to the FDA servicing laboratory. If the shipment is found to be in compliance after examination or analysis, the importer of record, consignee, or filer and CBP receive a Notice of Release. If a violation is found or the product appears to be in violation, the district office will decide whether the product should be detained. The filer, owner, and consignee, where applicable, are advised of such action by a Notice of Detention and Hearing. This notice specifies the nature of the violation and designates a site where the owner or consignee can come for an informal hearing. The owner may be able to correct the problem by relabeling or reconditioning the product, in which case the product is released. If this is not possible or not done when possible, the district may issue a Notice of Refusal of Admission by request of the importer or on its own decision. The FDA charges for its services in overseeing relabeling, destruction of prod- uct, or other action and sends these charges to CBP, which in turn sends a notice for payment to the identified importer of record. 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. Exportation of refused merchandise is done under CBP supervision. Failure to redeliver results in CBP issuance of a liquidated damage for up to three times the value of the shipment. The FDA’s New Foreign Posts One recent step forward in working with other countries on food safety is the FDA’s opening of foreign posts. These posts are located in China (Beijing, Guangzhou, and Shanghai), the European Union (EU) (Belgium, Italy, and the United Kingdom), India (Mumbai and New Delhi), and Latin America (Chile, Costa Rica, and Mexico). A table provided by the FDA, dated August 20, 2009, gives the status of staffing of these foreign posts (GAO, 2009). Fifteen of these positions are to be focused specifically on foods, as opposed to other FDA jurisdictional areas. The foreign posts have many purposes, including technical cooperation with foreign regulators,

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 APPENDIX E information exchange, better understanding of each other’s systems and requirements, and, where appropriate, inspections. Differences Between Domestic and Imported Food Regulation All in all, differences between the FDA’s domestic and imported food programs are readily apparent. With domestic firms, FDA field offices have access to and the ability to inspect the firms. They know where these firms are. The domestic food industry is more likely to know, understand, and be constrained by U.S. food safety laws. Industry trade and agricultural organizations actively communicate changes in U.S. regulations to firms and farmers. U.S. farmers and processors have access only to U.S.-approved pes- ticides and food and color additives, and thus cannot use products banned or never approved in the United States. The same applies to animal drugs used in meat or poultry production, recognizing that meat and poultry regu- lation falls under the purview of USDA’s Food Safety and Inspection Service (FSIS). And when a significant regulatory action is taken within the United States, the impact is felt not only by the target of that action but also by the industry as a whole, as industry trade groups publicize such actions to their membership. With imported foods, foreign producers may have difficulty understanding or accessing FDA requirements (although the FDA has put more foreign-language information on its website). Foreign producers may not have access to EPA-approved pesticides or FDA-approved veterinary drugs. Or producers, exporters, and importers simply may not do the homework. Despite globalization of the marketplace, word usually does not travel very far within a country when the FDA takes action on import shipments. 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. The FDA and Food Exports Unlike a number of other U.S. agencies that deal with food, the FDA does not have a food export program per se. The FDA was established as a scientific regulatory agency that would protect the U.S. consumer, and that has remained its primary mission. Until fairly recently, the statutes under- pinning the FDA’s mission did not focus on responsibilities outside U.S. bor- ders. In 1996, Congress passed the FDA Export Reform and Enhancement Act, which affirmatively established export responsibilities, but very little of this act applied to foods. In fact, a system of user fees for issuing export certificates for drugs and devices was included in the law, but nothing was

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0 ENHANCING FOOD SAFETY included on export certificates for foods. The FDA continues to discourage the issuance of food export certificates of any sort because the cost of their preparation far exceeds the $10 fee the agency collects under Freedom of Information Act (FOIA) provisions (actually, even that small fee does not go into supporting the export certificate activity within CFSAN). The FDA’s expectation is that the private sector should be responsible for knowing and observing the food safety requirements of other countries when exporting foods. The FDA has no part in monitoring the safety of food shipments exported from the United States, although all foods produced within the United States are subject to the FDA’s regulatory oversight. Generally, the FDA is willing to say, when it does issue an export certificate, that the product produced in the United States was subject to the laws of the United States, or words to that effect. The FDA does, however, work closely with other countries when they find an unsafe U.S food product to determine the cause and correct the situation. The same foods may pose a risk to the U.S. population or to other countries. The FDA also notifies governments of other countries when U.S.-produced foods found to be adulterated have been exported abroad. Other U.S. food-related agencies, such as FSIS, the Federal Grain Inspec- tion Service, and the Animal and Plant Health Inspection Service (APHIS), have export trade-related missions and laws to enforce. These agencies may require and issue export certificates or mandate and demonstrate equiva- lence of their programs to those of foreign systems. The FDA does have export rules under section 801(e) of the FDCA, basically saying that the agency will not find a product adulterated or misbranded if it is marked for export, accords with the laws of the importing country, was never offered for sale in U.S. commerce, and meets the foreign purchaser’s specifications. It is important to note, however, that this provision is applicable only when a product is found to be adulterated or misbranded. 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. For present purposes in comparing regulatory approaches, the focus is on USDA’s FSIS—responsible for the safety of meat, poultry, and processed egg products—and its APHIS, responsible for protecting U.S. agriculture (which may include fresh produce, meat and poultry, live animals, and forests) from exotic diseases and pests.

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 APPENDIX E FSIS Under the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act, and the Egg Products Inspection Act, imported products are prohibited from entering the United States unless the exporting country meets all food safety public health standards applicable to similar products produced in the United States. FSIS evaluates foreign regulatory systems in advance of any product being exported to ensure a program and require- ments equivalent to those of the United States. Although FMIA contained the concept of “at least equal to” prior to the WTO obligation in the Agree- ment on the Application of Sanitary and Phytosanitary (SPS) Measures that WTO members allow for equivalence of other countries’ food control sys- tems (Article 4), FSIS rethought its program after the SPS Agreement went into effect to ensure full compliance with the Agreement and prepared new guidance on FSIS equivalence procedures (FSIS, 2003).7 FSIS deals directly with the competent authority in the exporting gov- ernment in negotiating the equivalence determination, as the government is responsible for both demonstrating and maintaining the equivalent system. FSIS’s import program uses a three-part process to determine and maintain equivalence: (1) recurring analysis of the salient laws, regulations, and implementing policies and discussions with the exporting country to under- stand how the program operates; (2) on-site audits to verify the delivery of the program; and (3) continuous port-of-entry inspection of products shipped from eligible countries and foreign establishments. FSIS does not conduct actual inspections of facilities in the foreign country or certify foreign establishments for export to the United States. After a country has been judged to have an equivalent food regulatory system, FSIS relies on the country to carry out daily inspections, and the country’s chief inspec- tion official must certify a list of those establishments operating under its control that meet U.S. import requirements. FSIS also requires consignment- by-consignment import certificates. Eligible countries are listed in FSIS regulations 9 CFR 327.2 for meat, 381.196 for poultry, and 590.910 for egg products. There were 29 countries actively exporting meat, poultry, and egg products in 2008, with Canada being the only country exporting 7 The FDA partnered with FSIS in preparing the first version of this guidance, as the FDA was at the time preparing equivalence guidance of its own. The FDA’s draft guidance was published in 1997 (Draft Guidance on Equialence Criteria for Food, 62 FR 30593, June 4, 1997). Final FDA guidance was never published. 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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 ENHANCING FOOD SAFETY imported food, its hazards, and requirements of the FDCA, as well as the ability to take corrective actions. Further, the Secretary may incorporate “certification of compliance” under section 801(q) 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. Regula- tions must be written for all aspects of this section. Annual fee for importer registration—Importers of food are • required to pay an annual fee, initially set at $500 and to be adjusted in subsequent years. Registration of customs brokers—Customs brokers can have their • registration cancelled and be subject to civil penalties under section 205. There is no fee associated with this registration. Unique ID for food facilities, importers, and customs brokers—As • noted above, currently there can be multiple names for a particu- lar firm, making it very difficult to track shipments and problem firms. Prohibition against delaying, limiting, or refusing inspection—The • FDA conducts very few foreign inspections as they are expensive, and thus it generally limits them to high-risk firms or situations in which violative products or illnesses have occurred. In those cases where a foreign firm refuses or delays inspection (or, presumably, when a country refuses a visa to FDA inspectors), this provision allows the FDA to consider products coming from the firm to be adulterated, and entry of further products from that firm will be prohibited. Dedicated foreign inspectorate—The FDA will have a dedicated • cadre of foreign inspectors. For the most part, this is the case now, but a system that facilitates travel for this cadre is needed. Lead in ceramic ware—Ceramic ware with glazes containing lead • must be labeled as such, per section 216. Extraterritorial jurisdiction—This provision establishes as a pro- • hibited act “the production, manufacture, processing, preparation, packing, holding, or distribution of an adulterated or misbranded food with the knowledge or intent that such article will be imported” into the United States. This is a significant provision that allows the FDA to stop a product from entering the United States based on inspection of a facility. It is comprehensive in capturing every portion of the supply chain.

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 APPENDIX E OPPORTUNITIES TO IMPROVE THE IMPORTED FOOD PROGRAM The following are some opportunities for improving the FDA’s imported food program beyond those identified above: Establish a sizable, flexible, and separate set of best-practice tools • that can be utilized to regulate, negotiate, and take appropriate and proportional actions to deal with imported food safety issues. Although the overarching goal of the FDA’s domestic and imported food programs is safe food, the imported food program poses unique challenges and requirements. Further, the imported food program, unlike the domestic program, must have the appropriate linkages to the larger context of global food safety if it is to func- tion in an optimal manner. In dealing with a multitude of countries, food products, and conditions of production, the imported food program requires the flexibility to use the right tool for the job. Some of the tools needed are included in the opportunities for improvement that follow. Study other developed country and U.S. agency programs to deter- • mine whether their philosophies, practices, and techniques might have utility in FDA programs. A recent GAO report (GAO, 2008) provides some of the foundation for such a study. Still it would be useful for the FDA to expend the resources to see and better under- stand how these systems work in practice. An experienced team of FDA representatives from the commissioner’s office, CFSAN, ORA, and the Center for Veterinary Medicine (CVM) could carry out such a study within a short time frame (2−3 months) 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. More public meetings; brochures on the values, challenges, and benefits of the program activities; meetings with agencies, industry groups, and congressional staff; and outreach to embassies will foster understanding of the program goals, garner input on the program, and enable constructive buy-in for program objectives and mechanisms. Establish a tiered food import monitoring system that drives the • level of examination/sampling rate based on (1) the FDA’s knowl- edge, experience, and confidence with an exporting country’s food safety system; (2) the exporting country’s (or in some cases, private industry’s) ability to ensure that the imported food meets FDA

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 ENHANCING FOOD SAFETY requirements; and (3) the known level of food safety risk associated with the product type. Generally, other countries have established their lists of high-risk foods around foods derived from animals. For example and as noted earlier, the EU focuses on animal-derived foods and requires that countries have equivalence agreements with the European Commission in order to ship products to EU countries. The EU then audits the other countries’ programs just as it internally audits the programs of its Member States. While this system was a logical one for the EU as it was engaged in ensuring consistent food safety programs among the growing number of Member States and needed to demonstrate that “third countries” had to meet equivalent requirements, this system is not being sug- gested for the FDA. Instead, the FDA needs to have a multifactorial risk-ranking system, and with the advent of PREDICT should be able to implement high, medium, or low levels of examination upon entry of a product. Establish an importer licensing program, such that importers are • responsible for ensuring compliance with U.S. food safety laws, and licenses may be withdrawn based on set criteria. HR2749 contains an importer registration program whereby the registra- tion can be cancelled for cause, which is similar to this suggestion. A number of countries utilize importers as their point of control for food imports and work closely with them to ensure that they understand national food safety requirements and their responsi- bilities in making certain that these requirements are met. These countries believe these programs are effective and give importers an incentive to be stewards for the products and companies they represent. Implementing this suggestion would require legislation. It should be noted that in January 2009, the FDA issued draft guid- ance on GIPs (FDA, 2009e) for comment. HR2749 requires that importers observe these practices. 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. The FDA needs to have ORA, Office for International Programs, CVM, and CFSAN teams of skilled negotiators who can work regularly with other countries to resolve problems with noncom- pliant foods, using the various tools available to address the prob- lems. Perhaps countries are willing to address problems by using an accredited third-party certifier or by issuing export certificates for firms in which they have confidence, or they may not have an

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 APPENDIX E adequate food safety system to deal with the problems and need guidance or technical assistance. In any case, expert teams that can conduct country negotiations need to be seen as a routine part of the FDA’s public health regulatory armamentarium. Priority also needs to be given to negotiating agreements with countries with comparable food safety systems to reduce the use of FDA resources for product examination to the lowest level appropriate to the food risk. Maintenance of comparability assessments could be achieved through accredited third-party audits (governments could qualify as the accredited third party), similar to what is done for mainte- nance of equivalence by FSIS. Provide training in foreign negotiations for appropriate FDA staff. • As stated above, the FDA needs to work with other countries, still as a regulatory agency, to find ways to resolve problems, promote food safety, and minimize the risk of unsafe foods coming into the United States. Training in negotiations for qualified staff would ensure effective negotiations. 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. A study of the cost/ benefit of limiting these points of entry or limiting them for imports of high-risk products is needed. Whereas CBP is now able to take samples on behalf of the FDA, limiting ports of entry for food products is a tool used by FSIS and other countries for high-risk imports. Work with countries on import alerts to ensure that they are fully • aware of how to successfully address the issues involved in those alerts. Not only countrywide import alerts but also regular import alerts involving multiple firms may remain in place for a decade or longer. In bilateral discussions with countries, many are mystified as to how such import alerts remain in place for so long and what corrective actions they can take. The FDA needs to provide greater outreach to countries to clarify both procedures and FDA expecta- tions for safe imports. Take affirmative steps to provide outreach to foreign governments • and industry on FDA food safety programs and requirements. The FDA provides a vast amount of information on its website on its requirements and procedures. The agency could make a commit- ment to conducting more international outreach through its newly established FDA foreign posts, in partnership with the World Bank, the Foreign Agricultural Service, Washington embassies, and other federal agencies. Such outreach could include written materials for handouts, scripts and PowerPoints for speakers, foreign lan-

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 ENHANCING FOOD SAFETY guage flyers, appearances at international food conferences, and videoconferences. Allow long listings of DWPE products/manufacturers/importers to • enable time to negotiate with countries on regional or importing country solutions to avoid countrywide import alerts. Country- wide import alerts command the attention of other countries and relieve the FDA of having to sample products from all suppliers of similar products when multiple suppliers have already been found with the same type of violations. Nevertheless, there are other ways to command this same attention (e.g., raising the issue at an SPS Committee meeting in Geneva) without placing an entire country on DWPE. Good companies receive the same punishment as the companies that caused the food safety problem. Country- wide detentions should be a tool, but utilized in extremely rare circumstances. Require that importers pay for food safety examinations. Other • countries charge for food safety examinations at the border. Australia’s system is a possible model. 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) recognizing the importance of adher- • ing to obligations under the Agreement on the Application of SPS Measures under WTO and clarifying the FDA’s stance on the Codex Alimentarius standards and guidance. The FDA, as part of the federal government, is required to adhere to WTO obligations under the U.S. Uruguay Round Agreements Act. Nevertheless, although many countries modified their food safety programs and requirements to ensure compliance with the trade obligations, the FDA did not see a need to do so. As a public health agency, the FDA exists to protect public health, not to promote or enhance food trade. Still, a policy statement to clarify this posture and the FDA’s recognition of the necessity and intention to comply with SPS obligations (e.g., by continuing to base sanitary measures on scientific principles, to use risk assessment in developing the mea- sures, to base measures on international standards and guidance or state the scientific rationale for doing otherwise) would go a long way toward defining the standing of the U.S. Uruguay Round Agreements laws in relation to the FDA’s public health obligations. Similarly, this same or another policy statement could clarify the FDA’s stance on Codex Alimentarius standards and guidance. Amend 21 CFR 1.90 to eliminate the requirement that food prod- • ucts randomly selected for testing be held until test results are avail-

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 APPENDIX E able. This regulation states that when a product offered for import is sampled, the owner of the product should hold and not distribute the product until results of the sample analysis are known. This provision is necessary for products suspected of food safety viola- tions, but not those sampled on a random, or not-for-cause, basis. With less than 1 percent of foods sampled and with many of these products being raw and somewhat perishable, it does not make sense for the FDA to have to rush to have them analyzed so their quality will not diminish. Use surveillance sampling of food products solely to gather data • and intelligence to identify and prevent future problems. Targeted/ compliance sampling requiring bonding of shipments and prohibi- tion of distribution needs to be limited to situations in which the FDA has sufficient reason to suspect violations of the FDCA. 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. Find means to effectively utilize confidentiality agreements with • other countries to share data (1) on food products from their own countries and (2) on food products from third countries when such data can be used collaboratively to improve food safety oversight. The FDA currently has confidentiality agreements with a number of countries whereby there is mutual agreement to protect non- public information of the other party. Food safety information has been exchanged in foodborne outbreaks, and this should continue. Additionally, some countries could share regular monitoring data that could provide intelligence on new problems being found or, when combined with FDA findings, could confirm an emerging food safety problem. Determine an appropriate and nondiscriminatory means to enable • other countries to import shellfish and Grade A dairy products under state−federal cooperative programs—the Interstate Shellfish Sanitation Commission and National Conference of Interstate Milk Shippers, respectively. These solidly run regulatory programs, car- ried out primarily by the states, ensure appropriate sanitation for these high-risk products. Unfortunately, other countries cannot export shellfish or Grade A products to the United States without following these programs to the letter, including paying for state inspections. Despite some inroads with these organizations regard-

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 ENHANCING FOOD SAFETY ing the obligation to recognize equivalence in Article 4 of the SPS Agreement, in practice it has been difficult to evaluate equivalence when these two programs are so prescriptive in order to guarantee consistency across the 50 states. Provide for recognition of third-party audits of firms (by accred- • ited certifying bodies), and require import certification for food products when appropriate. The FDA has previously recommended these tools for improving imported food safety and specifically published guidance on certification of foreign facilities/systems by accredited certifying bodies. HR2749 also contains provisions that specifically authorize such systems. It should be noted, however, that third-party audits and so-called private standards are most useful in situations where foreign parties can afford to utilize such systems. 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. Options could be explored that might include a designated and sep- arate field food staff, food teams in each district that would report to CFSAN, CFSAN having its own field offices, having CFSAN policy/program staff work within ORA headquarters offices on food programs, CFSAN designating operational metrics for field staff performance plans, or any combination of such mechanisms. Consider an FDA policy on proportionality. Some countries see • proportionality as an obligation of countries under the SPS Agree- ment, which in fact does say that sanitary measures should be no more trade restrictive than necessary. In FDA parlance, the agency may occasionally refer to its use of regulatory discretion in ignoring, say, a minor misbranding violation. Nevertheless, the FDA in the past has expended considerable energy in taking regulatory action on residues and products presenting a negligible health concern. Such a statement of policy could provide much-needed guidance for explaining to Congress, stakeholders, and FDA staff the agency’s priorities in choosing to actively pursue public health violations, certainly for any imported food associated with illnesses, significant sanitation problems, pathogens, pesticide residues exceeding a legal tolerance, or in the absence of a tolerance, a Codex Maximum Residue Level. The policy would urge that common sense prevail in suiting the action to the seriousness of the violation.

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 APPENDIX E Veneziano, D. 2008. Import Process, Prior Notice, and Import Alerts. Presented at Food and Agriculture Border Gateway Summit, January 16, 2008. www.michigan.gov/documents/ mda/FDA_importproc_224440_7.pdf (accessed December 2, 2009). WTO (World Trade Organization). 1995. Agreement on the Application of Sanitary and Phytosanitary Measures. www.wto.org/english/tratop_e/sps_e/spsagr_e.htm (accessed November 30, 2009). WTO. 2009a. Glossary. www.wto.org/english/thewto_e/glossary_e/glossary_e.htm (accessed November 30, 2009). WTO. 2009b. Work on Priate Food Safety and Health Standards Moes to a New Phase. www.wto.org/english/news_e/news09_e/sps_25feb09_e.htm (accessed November 30, 2009).

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