This section discusses the offices within FDA and other federal agencies that help oversee imported food products. It also discusses FDA’s approach for overseeing the safety of the imported food products for which it is responsible, including milk, seafood, fruits, and vegetables. FDA’s responsibilities for overseeing the safety of imported food products are divided among its product centers and program offices. For example, the Center for Food Safety and Applied Nutrition (CFSAN) is responsible for regulating food and cosmetics products. FDA’s Office of Regulatory Affairs (ORA) is the lead office for ensuring the safety of imported food through various field activities, such as inspections of firms, review of imported products, examination of products, and sample collection and analysis. ORA works closely with the centers and with the Office of International Programs (OIP), which coordinates some of the agency’s international activities. FDA has staff in China, Chile, Costa Rica, India, Mexico, and the European Union. These foreign offices help ORA obtain foreign scientific and regulatory information, conduct investigations and facility inspections in foreign countries, and facilitate collaboration with foreign regulators in areas of common interest. Primary responsibility for imported food safety is divided between FDA and FSIS, but other federal agencies play a role. For example, CBP supports FDA in its enforcement of its food safety regulations at the border, among other things. CBP’s automated systems process all imported shipments, including food. In addition, NMFS provides fee-for- service inspection services, upon request, to the seafood industry— including domestic and foreign processors, distributors, and other firms— for example, to certify that these seafood firms comply with FDA’s Hazard Analysis and Critical Control Point regulations and other federal food safety standards. Some retailers request this certification as a condition for purchasing seafood products. FDA oversees the safety of imported food by promoting corporate responsibility, examining food prior to it entering into U.S. commerce to help ensure that unsafe food does not enter the country, and responding when unsafe food does enter the country. In 2011, FSMA provided FDA with new provisions that hold imported foods to the same standards as domestic foods and prevent unsafe food from entering the country. These new provisions included new requirements and authorities for FDA, including a requirement to develop a comprehensive plan to expand the food safety capacity of foreign governments; a requirement to increase inspections of foreign food facilities and the authority to enter into cooperative arrangements with foreign governments to facilitate the inspection of foreign food facilities; the authority, under certain circumstances, to require as a condition of admission that imported food be accompanied by certifications or assurances from accredited third-party certification bodies, agencies, or representatives of foreign governments where the food originated; and the authority to require importers to verify that their foreign suppliers meet applicable U.S. food safety standards. Owing in part to the volume of imported food, FDA cannot physically examine every shipment; the agency examines about 1 percent of entry lines annually. FDA electronically screens all imported food shipments to determine which imports to physically examine at the border and which imports to allow into U.S. commerce. The electronic screening process consists of two phases: (1) Prior Notice screening, which is intended to protect against potential terrorist acts and other public health emergencies, and (2) admissibility screening, which is intended to ensure that the food is admissible under the Food, Drug, and Cosmetic Act (FDCA). Imported food products are generally considered admissible if they are in compliance with applicable FDCA regulations that ensure food is not adulterated, misbranded, manufactured or packed under insanitary conditions, or restricted in sale in the country in which it was produced or from which it was exported, among other things. The first phase, Prior Notice screening, requires that an importer, broker, or other entity submit notification to FDA of food being imported or offered for import into the United States before that food arrives at the port of entry. Prior Notice information includes data such as the names and addresses of the manufacturer or grower, importer, owner, and ultimate consignee (the “deliver to” location); FDA product code for the food item; and country of production. Information that FDA uses for Prior Notice review can either be submitted electronically through CBP’s system, which passes the information to FDA, or submitted electronically directly to FDA. FDA targets, screens, and reviews the information to ensure that the information meets the Prior Notice requirements and to determine whether the food potentially poses a terrorism threat or other significant health risk. If such risks are identified, FDA is to work with CBP to examine the shipment upon arrival at the port. If adequate Prior Notice information is not provided, the food is subject to refusal of admission and may not be delivered to the importer, owner, or consignee. If FDA subsequently verifies that adequate Prior Notice information is provided and the food does not appear to pose a terrorism threat, the shipment is allowed to proceed to FDA’s admissibility screening. During the second phase, admissibility screening, FDA electronically screens entry lines using PREDICT to determine their level of risk. “Risk”—reflected by the PREDICT risk score—includes factors such as the inherent health risk of the product, compliance risk associated with firms, facility inspection results, and broker history, among others, and is then compared to all other entry lines within a specified commodity over the past 30 days. If PREDICT determines that an entry line poses a low risk, PREDICT recommends the entry be allowed to enter into U.S. commerce, and another FDA system, called the Operational and Administrative System for Import Support (OASIS), issues a system- generated “May Proceed” message, allowing the product into U.S. commerce without further review. If PREDICT determines that the entry line poses a high risk, an entry reviewer decides whether to examine the entry line for admissibility. The entry reviewer determines if the entry line is under import alert. If the entry line is not under import alert and no further examination is needed, the entry reviewer allows the entry line into U.S. commerce by issuing a manual “May Proceed” message through OASIS. The entry reviewer may determine that a field or laboratory examination is needed for an entry line that is not under an import alert. In this case, an FDA investigator examines the entry either at the port of entry or at another location, such as the importer’s or consignee’s warehouse or a cold storage facility. The investigator may examine a product’s label to determine whether it meets labeling requirements. Additionally, the investigator may examine the shipment for rodent or insect activity or inadequate storage while in transit, among other things. Figure 2 shows FDA investigators examining imported food. If the product does not appear to be violative after the examination, the owner or consignee receives a notice stating that the line is released, and the product is allowed into U.S. commerce. If the product appears to be violative, the investigator may decide to take samples from the product for a laboratory examination to test for rodent or insect activity and other such elements that could confirm that the entry is violative. If the samples indicate that the food is not violative, the owner or consignee receives a notice stating that the line is released, and the product is allowed into U.S. commerce. If the samples are violative, the owner or consignee receives a notice stating that the line is being detained and is subject to refusal. Once the owner or consignee receives a notice stating that the line is being detained and is subject to refusal, the owner or consignee may request that FDA immediately refuse the product, and the product must either be exported or destroyed. If the owner or consignee does not request refusal, then the owner or consignee decides whether to submit testimony or request to “recondition” the product—for example, relabeling the product or converting the product into a type of product not regulated by FDA. If the owner or consignee submits testimony regarding the admissibility of the food or FDA approves a request to recondition the product, then an FDA hearing determines whether the product should be released. If FDA determines that the owner or consignee has provided sufficient information to overcome the appearance of a violation, the owner or consignee receives a notice stating that the product is released. If FDA determines that the owner or consignee’s actions failed to bring the product into compliance, the food must be exported or destroyed. If the product is subject to an import alert, FDA determines whether the product should be detained without physical examination. If FDA determines that the product should not be detained, the owner or consignee receives a notice stating that the product is released. If FDA determines that the product should be detained, FDA issues a notice stating that the line is being detained and is subject to refusal, and the owner or consignee decides whether to export or destroy the product. Figure 3 illustrates the key elements of FDA’s screening process. From 2012 to 2014, about 0.1 percent of all food entry lines were refused and exported or destroyed each year. During this period the countries with the highest number of entry lines that were refused were India, Mexico, and China and the most commonly refused items included rice, herbals and botanicals (not teas), tuna, shrimp and aquaculture- harvested seafood products, and vitamins and minerals. When unsafe food enters the country, FDA may respond by issuing advisories about the affected food. Depending on the circumstances, FDA may also use other enforcement tools, such as seizure, injunction, and administrative detention. FDA can also seek voluntary recalls of unsafe food. If a responsible party does not voluntarily recall the food, FDA may issue a mandatory recall order, provided that certain criteria are met.