As a popular soup ingredient, dried fish is frequently imported to the United States – usually not eviscerated.
Import Alert 16-74 is an Alert specifically focused on uneviscerated fish: the Alert instructs FDA’s compliance officers to detain (and ultimately refuse, if safety is not proven) all shipments of uneviscerated fish that are salt-cured, dried, smoked, pickled, fermented or brined – essentially, anything not cooked. FDA implemented the import alert after C. botulinum in fermented and dried fish caused massive food sickness outbreaks in the 1980s and 90s. The Alert currently covers many types of fish, such as anchovies, bloaters, sardines, and croaker.
Since its implementation, the Alert has had significant effects on processed fish trade between Asian countries and the United States. For example, prices of dried anchovy in the United States jumped by as much as 20 to 50 percent in 2012 because of FDA refusals. In fact, our analysis shows that firms are still suffering – FDA refused over 80 entries from Korea alone over the past two years. The actual effect of the Alert on overall trade is probably much greater than what that number shows, because dried or cured fish constitute an important part of cuisine in many cultures around the world.
As always, the question then is – how do we solve this problem? How can firms get off the Import Alert? FDA receives its authority to detain imported articles from what is called the appearance standard – in short, FDA can detain articles without any proof if they simply appear violative of the Food, Drug and Cosmetic Act (FDCA). So, any solution must involve removing this appearance of violation.
In short, affected parties must show their products are handled and processed in a way that controls C. botulinum’s potential for growth in the food. Specifically, this must be shown by submitting competent HACCP (Hazard Analysis and Critical Control Point) plans to FDA for the Agency’s review. The HACCP plan must show how a firm eliminates pre-formed toxin (e.g., through boiling), as well as how the processed product will have controls preventing further growth of C. botulinum (e.g., 20 percent water-phase salt level; water activity that is lower than 0.85; pH of 4.6 or less). Importantly, this is only feasible if the imported fish is less than five inches long – FDA believes fish five inches long or longer cannot be processed adequately without evisceration.
We must warn, though, that firms attempting to be removed from the Import Alert or to be placed on the Green List must be absolutely certain that their processes comply with FDA’s standard. If FDA finds issues with your seafood HACCP plans, FDA may place you on another Import Alert – IA 16-120, regarding non-compliant HACCP plans. Before submitting any HACCP plans to FDA, we recommend that you identify all the critical control points in processing steps, and that sufficient processing steps are in place to control any potential hazards.
If you have any questions about the Import Alert, or what you need to do to be removed from it, please do not hesitate to contact us. FDAImports.com can provide immediate assistance in dealing with shipments automatically detained for any reason – including this import alert. We can also provide assistance with HACCP compliance and other FDA or Customs regulatory issues.
