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  1. Sampling to Protect the Food Supply

Microbiological Surveillance Sampling: FY16-17 Hot Peppers

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The U.S. Food and Drug Administration (FDA) set out to collect and test hot peppers in 2015 under the agency’s new proactive and preventive approach to deploying its sampling resources with the ultimate goal of keeping contaminated food from reaching consumers.

The new approach, detailed in the Background section of this report (page 5), centers on the testing of a large number of samples of targeted foods over a relatively short period, about 18 months, to ensure that enough data are available to inform decisions. This approach may help the agency determine if there are common factors – such as origin, variety or season – associated with pathogen findings.

The FDA issued the hot peppers assignment in November 2015 under its new sampling model. The agency collected 1,615 samples to test to determine the prevalence of select pathogens in the commodity. The agency collected about 80 percent of its samples from imported hot peppers and the rest from domestically produced hot peppers, comparable to their respective market shares at the outset of the assignment. The agency designed its sampling plan such that if contamination of one percent or greater was present in the commodity, the agency would be likely to detect it. The agency monitored the assignment closely to gather lessons learned and to make changes to its sampling procedures if needed to address trends or food safety issues.

For purposes of this assignment, the FDA targeted the fruit of the genus Capsicum (e.g., habanero, jalapeño and serrano peppers) and not the fruit of the genus Piper (e.g., black or green peppercorns), following an agency prioritization of foods to be sampled based on potential microbial risk and associated data gaps.

The FDA tested the hot pepper samples for Salmonella and Escherichia coli (E. coli) O157:H7, as well as for other types of Shiga toxin-producing E. coli (STEC). Based on the test results, the FDA found the overall prevalence of Salmonella in the samples collected to be 2.85 percent. The agency did not detect E. coli O157:H7 in any samples. The FDA detected a different STEC strain (i.e., non-O157) in one sample, but further testing determined that it was incapable of causing severe illness.

Among the agency’s other findings, the prevalence of Salmonella in imported hot peppers was 3.48 percent (46 positive, out of 1,293 tested), and the prevalence of Salmonella in domestically grown hot peppers was 0.31 percent (one positive, out of 322 tested). A statistical test found the difference in prevalence to be significant. With respect to the imported product, the FDA found hot peppers grown in Mexico to have a Salmonella prevalence of 2.61 percent (29 positive, out of 1,112 tested), and hot peppers grown in the Dominican Republic to have a Salmonella prevalence of 8.33 percent (7 positive, out of 84 tested).

The initial findings for hot peppers grown in the Dominican Republic warranted further investigation, so the FDA conducted intensified screening (i.e., additional sampling) as a supplement to the agency’s main assignment. The results of the intensified screening were consistent with the initial findings. The FDA placed two firms in the Dominican Republic and their product on Import Alert 99-23, “Detention without Physical Examination of Produce Due to Contamination with Human Pathogens.” Also, as the circumstances did not meet the agency’s criteria for a countrywide import alert, the agency worked directly with the country’s Ministry of Agriculture and Fisheries. The ministry instituted training sessions for growers, packers and transportation intermediaries. The ministry also conducted its own sampling of hot peppers in 2017 and did not detect Salmonella.

In response to the Salmonella-positive samples from Mexico, the National Agro-Alimentary Health, Safety and Quality Service (SENASICA), or state investigators acting on its behalf, conducted follow-up visits at the identified firms. The visits included sampling of water, food contact surfaces, non-food contact surfaces, hot peppers and other produce. The sampling did not detect Salmonella in the samples tested. Additionally, SENASICA carried out environmental investigations at nine firms having the highest incidence of positive findings by the FDA, where they identified practices to be corrected. The FDA placed seven firms in Mexico and their product on Import Alert 99-23.

The FDA addressed all the import samples that tested positive for Salmonella. Specifically, the agency refused entries of hot peppers in lots associated with positive samples and, where the criteria was met, placed the responsible firms and product on Import Alert 99-23. In all, the agency placed 10 firms on the import alert (seven in Mexico, two in the Dominican Republic, and one in Haiti). The FDA also worked with importers to conduct five voluntary recalls. To address the domestic sample that tested positive for Salmonella, the FDA worked with the firm that owned the affected hot peppers to conduct a voluntary recall.

The FDA will continue to evaluate methods to reduce microbial contamination of hot peppers. Such contamination remains a concern to the FDA given this assignment’s findings and the results of other research, even though the available consumption data indicate that hot peppers are frequently subjected to a ‘kill step,’ such as cooking or pickling, prior to consumption. The agency advises growers, both domestic and foreign, to familiarize themselves with the agency’s Produce Safety Rule[1], as applicable, since hot peppers are “covered produce” subject to the provisions of the Produce Safety Rule. Additionally, the findings underscore the need for hot pepper importers to comply with the agency’s Foreign Supplier Verification Programs Rule[2] as applicable.

The agency will continue to sample hot peppers, including targeted surveillance sampling of imported product from countries of interest. As part of the targeted import sampling, the agency will use its PREDICT tool,[3] which assists entry reviewers in targeting higher-risk shipments to be examined. The FDA also may sample hot peppers using its longstanding approach to food sampling, which centers on (but is not limited to) the following criteria:

  • A firm has a previous history of unmitigated microbial contamination in the environment (e.g., human illness, recalled or seized product, previous inspectional history, or environmental pathogens without proper corrective actions by the facility), or
  • Inspectional observations that warrant collection of samples for microbiological analyses.

Employing the approaches described above, the FDA will sample hot peppers as warranted and take other steps consistent with its mission to protect consumers.

[1] The Produce Safety Rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.

[2] The Foreign Supplier Verification Programs Rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.

[3] PREDICT improves import screening and targeting to prevent entry of adulterated, misbranded, or otherwise violative goods and expedites the entry of non-violative goods.

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