The third element of the program pilot is to establish “standardized, transparent, and collaborative processes and communications.” While there are significant criticisms that can be made about the operation of the pilot in this area, its implementation has also at least acknowledged the economic concerns of importers.
Unfortunately, FDA’s notification of interested parties about the pilot’s implementation was uneven, as some domestic producers knew of the pilot well in advance, while many avocado importers did not learn of the program until it had begun in May. There has also been very little information available publicly about the pilot program or its operation.
What is the FDA looking for in these samples?
Through the avocado program pilot, the FDA is only collecting and analyzing samples of whole pit avocados for the presence of numerous microbiological contaminants. The avocado sampling program pilot reportedly calls for the collection of a total of 1,600 samples during the May 2014 to May 2015 period, with 1,120 samples (70 percent of the total) to be taken from imports at ports of entry, and 480 samples (30 percent) to be taken from domestic production.
These proportions are consistent with U.S. Department of Agriculture (USDA) estimates of import and domestic production volumes. The FDA is testing avocado samples for Salmonella and Listeria monocytogenes, although testing methods for Listeria monocytogenes in avocado pulp were reportedly still under development.
As explained below, FDA has indicated that regulatory action will only be taken if avocado samples test positive for Salmonella. Surveillance requirements for avocado pilot sampling are likely programmed into the FDA’s PREDICT (Predictive Risk- based Evaluation for Dynamic Import Compliance Targeting) screening system, which results in flagging particular entries.
Sampled avocados are subjected to both initial screening test methods, as well as follow-up confirmatory testing for which the initial analytical results were a “presumptive positive.”
In its May 23, 2014 release of information about the avocado sampling program pilot, FDA explained that “the majority” of the samples from import shipments will be “collected outside of the import admissibility process.”
Such sampling is not “for cause,” but for gathering information about food safety problems, and has traditionally been used to identify a violative shipment before it enters the United States.
How Does Surveillance Sampling Differ From The “Import Admissibility Process”?
Under the normal import admissibility process, FDA reviews entries to determine whether a food product appears from examination or otherwise to be inadmissible. In this process, the FDA is authorized to detain an import shipment, examine the product through sampling, and then refuse the product if it is determined to be inadmissible.