Food
Import Alert 16-81
Import Alert 16-81: Detention of Seafood Products
Background
FDA created this Import Alert for listing foreign seafood firms that have had Salmonella contamination problems. This import alert does not include shrimp from Bangladesh, Hong Kong, India, Indonesia, Taiwan, and Thailand, covered by Import Alert 16-18, or shrimp from India, covered by Import Alert 16-35. All other seafood and shrimp products tested and found to contain Salmonella appear on the Red List for this Import Alert. Although FDA created this Import Alert because of the severity of the food-borne illness caused by Salmonella, it covers raw, uncooked seafood as well as cooked Ready to Consume seafood. Of course, unless fresh or frozen raw seafood is intended for raw consumption, later cooking would destroy any Salmonella in the product. This demonstrates FDA’s “zero-tolerance” for Salmonella in food, which is mostly due to the cross contamination risks represents.
How do Firms get on this Import Alert?
FDA adds firms to this Import Alert if any of their products test positive for Salmonella. Just one positive sample will prompt FDA to refuse the tested shipment, resulting in destruction or exportation of the entire tested lot, and t0 place the firm on the Red List of this Import Alert, resulting in Automatic Detentions of all future shipments of the same (or even similar) products from that foreign processor.
Effects on Businesses Involved
Raw seafood is highly perishable. Consequently, this Import Alert can significantly restrict a company’s access to the U.S. market because of the delays caused by FDA Automatic Detentions. It is not uncommon that resolving FDA Automatic Detentions through private laboratory testing can take longer than the shelf life of raw, fresh seafood. Because Salmonella is considered a significant food safety risk the public nature of this Import Alert can be very damaging to a company’s business with existing customers. Even if future shipments are clean, FDA will Automatically Detain them until the processor and its products are removed from the Red List. FDA may also require foreign processors to submit corrective actions and a new Hazard and Critical Control Point (HACCP) plan for Agency review prior to releasing shipments. That HACCP plan review, if required, will significantly increase delays because the plans are rarely reviewed by the FDA officer detaining the shipment but have to be submitted to FDA Headquarters for review.
How do Companies get off this Import Alert?
Firms can be removed from this Red List, but shipping five consecutive clean shipments alone will not solve the problem. Rather, evidence must be submitted to FDA in the form of a Import Alert Petition proving that the reasons that led FDA to add the firms to the Red List have been resolved. Companies should consider requesting an Import Alert Petition Viability Review to determine whether there is adequate evidence to prepare and submit an Import Alert Petition.
Import Alert 45-02
Import Alert 45-02: Foods Containing Illegal/Undeclared Colors
Background
Manufacturers must use FDA-approved colorants in food. FDA has determined that some colorants are unsafe and therefore illegal to use in human and animal foods. Colorants that are illegal in the United States may be permitted in other markets, such as the European Union, so a Company could accidently send the wrong product to the USA rather than a market where the color is permitted. Regardless of whether the manufacturer meant to use the illegal colorant or to send the shipment to the USA, FDA will add the manufacturer and its food to the Import Alert Red List.
How do Firms get on this Import Alert?
FDA reviews product labels and randomly tests products entering the United States. If an adulterated colorant is found, FDA detains the goods and adds the firm to Import Alert. Also, if a food label ingredient list declares a color incorrectly, FDA will presume that the color is not permitted or from an uncertified batch. This can cause FDA to add the company to the Import Alert Red List.
Effects on Businesses Involved
Manufacturers on this Import Alert will experience costly delays when FDA automatically detains the products. Some foods listed on this Import Alert are perishable. Automatic detentions of perishable food items can take so long to resolve, the shipment is spoiled and commercially lost. Moreover, many holiday items contain specific colors that FDA will suspect are illegal, resulting in additional testing of other foods from the same Red Listed manufacturers. Missing delivery windows for holiday items can be financially devastating to a company.
How do Companies get off this Import Alert?
Food Companies on the Red List will be required to identify, correct and document the manufacturing or labeling problems that originally caused FDA to add their food products to this Import Alert. A firm should consider receiving an Import Alert Petition Viability Review to correct the critical safety and manufacturing issues. In addition, if FDA originally placed the company on the Import Alert based upon a labeling error, food companies should consider a Food Label Review.
Import Alert 99-19
Import Alert 99-19: Detention of Food Products Due To Salmonella
Background
While many Import Alerts relate to Salmonella contamination in specific food types (like seafood or shrimp), this Import Alert is a catch-all for all food products found to contain Salmonella. FDA has determined that many different foods, such as raisins, chocolate, fresh produce contain Salmonella. FDA created this Import Alert to provide guidance to districts, telling them they may automatically detain specific products exported or manufactured by those firms on the Red List.
How do Firms get on this Import Alert?
FDA adds companies to this Import Alert if any of their food products have been tested and were discovered to be contaminated with Salmonella. FDA is particularly concerned with Ready To Consume (RTC) foods – those that require no further processing before they are customarily consumed. Therefore, fresh produce, finished chocolate or other candies, breads and cereals, and raisins or dried goji berries are good candidates for this Import Alert if FDA finds they are contaminated.
Effects on Businesses Involved
A firm will find this detention costly since it affects the life, value and quality of the food item. Some foods on this alert are perishable or have only a moderate shelf life. The delays in the supply chain and logistics due to the import alert will cause some of the automatically detained food to become significantly reduced in value. FDA has zero tolerance for Salmonella in most cases. So contaminated foods will be refused, and exported or destroyed.
How do Companies get off this Import Alert?
Companies can petition FDA to be removed from this Import Alert. You must show there is no longer an a basis to believe future shipments will be contaminated with Salmonella. However, this will require more than just multiple clean entries and an Import Alert Petition. A firm should consider receiving an Import Alert Petition Viability Review to determine the best arguments and facts for obtaining removal from this import Alert.
