In contrast to the normal import admissibility process, because the avocado sampling program pilot involves fresh produce and was intended to be for surveillance rather than enforcement purposes, there are a number of “ground rules” to address the economic concerns of importers.
According to FDA’s May 2014 notice, once a sample from an import shipment is identified, unless there are other issues, FDA will issue a release. After the sample has been tested through the initial screening methods, the importer will typically be notified of the results within three days that the results were presumptive negative, presumptive positive, or “cannot rule out.”
For samples initially tested to be presumptive positive, confirmatory results will typically be available within an additional five to eight days. Because these determinations are made outside of the normal import admissibility process, the shipments from which the samples were taken were not under an import hold, so importers are permitted to distribute these products.
For shipments released by the FDA and later determined to be contaminated with Salmonella, FDA has explained that it will “work with the importer to address the issue.” In at least one case, avocados determined to be contaminated with Salmonella were the subject of a recall.
In contrast to the processes described in the notice, FDA’s typical approach in at least one port appears to be the issuance of a ‘Notice of FDA Action’ when avocados in an entry or entry line have been collected (rather than selected) for sampling.
While the FDA notice explained that shipments would be released upon being identified for sampling (unless there are other “known issues”), this does not appear to be the practice in at least some ports.
In these ports, FDA releases have not been issued until up to four days after the sample was collected. In these instances, the FDA releases were issued in accordance with the timeframes for initial analytical results (i.e., three days).
When Will The FDA Take Regulatory Action?
If a sample from a released shipment is later determined to contain Salmonella or Listeria monocytogenes, the FDA would then “work with” the importer to address the issue. While the meaning of this phrase is unclear, it could include encouraging a recall of the contaminated product, as has occurred for domestically produced avocados.
The FDA was clear to explain that “the majority” of the avocado samples from import shipments will be “collected outside of the import admissibility process,” which implies that a “minority” of the samples from such shipments may be taken as an enforcement activity subject to regulatory action. If FDA does take regulatory action, it would likely be in the form of subjecting future shipments to detention without physical examination by placing products on an Import Alert.
Completion of the Avocado Sampling Program Pilot
The FDA expects to complete the avocado program pilot in May 2015, and will likely issue a report sometime in the future. Importers of avocados have little recourse at this point but to cooperate with the FDA in the sampling pilot, and plan for whatever delays may result.
