Our team has noted a recent and significant uptick in the Food and Drug Administration’s (FDA) enforcement with respect to seafood imports. Specifically, FDA has been heavily encouraging the use of the draft guidance document entitled “Reconditioning of Fish and Fishery Products by Segregation: Guidance for Industry.” Although technically nonbinding, the Agency is leaning so heavily on this guidance that it is having the practical effect of a final rule.
Of course, FDA may detain a seafood shipment on the basis of a detected pathogen, such as salmonella, or decomposition after FDA sampling and testing. Previously, it was sufficient to request release of untested lines or providing private laboratory test results of samples collected from lines FDA did not test. However, since FDA has been winding down its COVID-19 activities, the Agency began implementing the Reconditioning guidance – with a vengeance.
Under the FDA’s Reconditioning Guidance, the importer has an opportunity to file a Form 766 request to recondition the shipment by segregating and testing the previously untested lines of seafood in the entry. But there is a catch.
This guidance offers two options for a reconditioning proposal:
1. Segregation based on a production-related rationale identifying the cause of the adulteration and its restriction to only a portion of the article, along with confirmation and testing
This option requires that the foreign supplier perform a root cause analysis identifying how the adulteration occurred. The supplier must then provide an explanation, supported by documentation, for how this adulteration came to be limited to only a portion of the shipment. In support of this theory, the importer must sample and test (by a private lab) a representative number of units.
2. Segregation based on sampling and testing results alone
If a foreign supplier is unable to adequately identify a root cause and/or demonstrate that the adulteration is confined to certain portions of the entry, the importer may propose a reconditioning based on testing alone. This method requires testing significantly more product than option 1; in some cases, ten times as much.
Although more straightforward, option 2 can be prohibitive in terms of cost and private laboratory capacity. Certain situations would require nearly 100% testing of the entire load, which would often be impossible to achieve. Therefore, Option 1 is the most realistic choice for importers pursuing a seafood reconditioning. However, note that FDA expects the supplied rationale and documentation to be very robust. A hypothesis is not sufficient; the root cause of the adulteration must be conclusively identified, documented, and shown to be absent from the product to be segregated and tested.
The upshot is that to be able to sample a reasonable number of seafood “sample units,” you must have a rationale justifying segregation – and FDA gets to decide whether your rationale is reasonable. If you do not have a rationale for segregation (or one that FDA does not think is adequate or reasonable), then the sample sizes become cost-prohibitive and, frankly, the private laboratories could not handle the sample/test load for one container in less than a 2–3-month time period.
Our team has experience with drafting successful reconditioning proposals in accordance with this FDA guidance. If you are seeking to recondition a seafood shipment, please contact us today.
