FDA Releases Report on Sampling of Fresh Herbs for Pathogens

The FDA released their report for the "Microbiological Surveillance Sampling: FY17-21 Fresh Herbs (Cilantro, Basil & Parsley) Assignment". In this project, FDA completed its collection and testing in September 2021, having obtained 1,383 samples in all.  "The samples collected were tested for Cyclospora cayetanensis, Salmonella spp., and Shiga toxin-producing Escherichia coli (STEC). The assignment aimed to estimate the prevalence of these pathogens in the three types of fresh herbs and to take follow-up actions in the case of pathogen findings, as warranted. The agency also sought to identify common factors, such as origin, among the pathogens’ findings."

 The results can be found here - https://www.fda.gov/food/sampling-protect-food-supply/microbiological-surveillance-sampling-fy17-21-fresh-herbs-cilantro-basil-parsley-assignment

Cyclospora cayetanensis Findings

• C. cayetanensis in 11 of the 120 basil samples, 7 of the 553 cilantro samples, and none of the 139 parsley samples, an estimated prevalence of 9.2% for basil, 1.3% for cilantro, and 0% for parsley.
• The agency detected C. cayetanensis in 18 samples out of 812 domestic and imported samples collected and tested

Salmonella spp. Findings

• Salmonella spp. in 7 of the 248 basil samples, 8 of the 849 cilantro samples, and 2 of the 261 parsley samples, an estimated prevalence of 2.8% for basil, 0.9% for cilantro, and 0.8% for parsley.
• The FDA detected Salmonella spp. in 17 samples out of 1,358 domestic and imported samples collected and tested.

STEC Findings

• The FDA detected STEC in none of the 242 basil samples, 1 in 849 cilantro samples, and none of the 259 parsley samples, an estimated prevalence of 0% for basil, 0.1% for cilantro, 0% for parsley.
• The agency detected STEC in one (1) domestic sample out of 1,350 samples collected and tested.

Actions Taken

• As to the domestic samples that tested positive for a target pathogen, the agency worked with each firm that owned or distributed the adulterated herbs to effect four voluntary product recalls.
• With respect to the import samples that tested positive for a target pathogen, the FDA refused to admit 20 shipments associated with positive findings into the U.S. and placed the responsible firms and product on Import Alert 99-23 and/or Import Alert 99-35, thereby requiring additional controls for future entries.

https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-summary-report-fresh-herbs-sampling-assignment
FDA Releases Summary Report on Fresh Herbs Sampling Assignment
Constituent Update
July 26, 2024

Today, the U.S. Food and Drug Administration (FDA) released findings from a sampling assignment that collected and tested both domestic and imported fresh basil, cilantro, and parsley. The assignment sought to estimate the prevalence of Cyclospora cayetanensis, Salmonella spp., and Shiga toxin-producing Escherichia coli (STEC) in these herbs as part of the FDA’s ongoing effort to help proactively ensure food safety.

From September 2017 to September 2021, the FDA collected and tested a total of 1,383 samples of fresh basil, cilantro, and parsley. The agency detected Salmonella spp. in 17 out of 1,358 samples, detected C. cayetanensis in 18 out of 812 samples, and detected STEC in 1 out of 1,350 samples. The FDA worked closely with the firm to quickly remove the contaminated products from the market. The sampling assignment took longer than anticipated, due to a nine month pause during the COVID-19 pandemic.

Fresh herbs contaminated with Salmonella spp., C. cayetanensis, and STEC can present a significant public health risk. From FY2000 through FY2016, cilantro was potentially linked to at least three outbreaks in the U.S. And since 2017, the U.S. has experienced at least six additional outbreaks involving basil, cilantro, and parsley. More than 1,200 illnesses and 80 hospitalizations were tied to these outbreaks. Thus, the FDA determined that sampling may help the agency assess the prevalence of pathogens in the commodities and identify common factors among contaminated samples, with the goal of helping to protect consumers.

Given the findings of the assignment, the FDA encourages industry to ensure its compliance with the agency’s Produce Safety Rule, Preventive Controls for Human Food Rule, and FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods, as applicable. Importers of fresh herbs should ensure their compliance with the agency’s Foreign Supplier Verification Programs Rule.

This sampling assignment was the agency’s first largescale field activity to focus on fresh basil, cilantro, and parsley. This data will help the agency develop guidance and update program priorities, including future sampling assignments and the prioritization of surveillance inspections. The FDA will continue to sample these fresh herbs for pathogens as warranted to protect consumers.