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The Avocado Surveillance Sampling Program

What it is, and what it’s not
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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.

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Last May, the U.S. Food and Drug Administration (FDA) began a new program to sample imported and domestically-grown whole pit avocados to test for microbiological contamination. Aptly named the “Avocado Surveillance Sampling Program Pilot,” testing is already underway and is expected to conclude by May 2015.

Why Has the FDA Created This ‘Surveillance’ Program?
The FDA has long collected information about the contamination of imported and domestic produce and other foods to develop new food safety policies and procedures. In conducting this type of surveillance sampling program, FDA is typically interested in determining the rate of contamination and in developing regulatory procedures to protect consumers and foster corrective action by the food industry.

The Food Safety Modernization Act (FSMA) was cited by FDA as a part of the reason for the microbiological contamination sampling program pilot. Although section 205 of FSMA (titled “Surveillance”) does not provide additional authority to the FDA to conduct surveillance sampling activities, it does require the agency to review its strategies to coordinate and share information with the Centers for Disease Control and Prevention (CDC).

Further, although the FDA is required to identify high risk foods, it is uncertain to what extent “high risk” foods—for purposes of surveillance sampling—may correspond to any future import certification requirements under FSMA sections 303 or 204.

The microbiological contamination surveillance sampling program pilot has three elements. The first is the goal of collecting statistically significant contamination data so the FDA may proactively identify public health risks. In announcing this new sampling program for avocados, FDA is acknowledging previous sampling approaches had not yielded the hoped for results. This was partly because past surveillance practices were deemed as overly broad and did not yield statistically significant results.

The second element focuses on foods that present the greatest public health risk. Criteria for identifying these high risk foods include their contribution to foodborne illness outbreaks, level of consumption (generally or by high- risk populations), ready-to-eat foods or ingredients thereof, foods that regularly come into contact with known contaminated sources, and foods that are cooked by consumers or processed without a ‘kill’ step (i.e., actions to destroy pathogenic microorganisms).

On the basis of these criteria, in part, FDA identified a number of food products to be used in various surveillance sampling pilot programs, including imported and domestically-produced whole pit avocados.

While the domestic avocado industry has stressed that fresh avocados are a low-risk product, CDC reports have suggested that while avocados alone have not been directly implicated in foodborne illness outbreaks, guacamole has arisen as a vehicle of foodborne illness outbreaks, and of course, avocados are the principal ingredient of guacamole. The FDA’s notice also indicated that avocados do have characteristics associated with susceptibility to some microbiological pathogens.

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.

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.

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