In our last newsletter we talked about FDA testing of spices and some concerns for spice users. In this week’s newsletter we are continuing the same theme of FDA testing and some “watch outs” for the food industry, but this time with a focus on fresh herbs and avocado. FDA recently began sampling some fresh herbs along with guacamole and processed avocado – and the results are quite significant for importers, processors, distributors, and retailers of these products. The reason for the early heads up from me on this one, even though the study is not yet complete, is that FDA is already finding Listeria monocytogenes in guacamole. They are also finding Salmonella and STECs in fresh herbs. All of which are leading to recalls if the products are in commerce in the US. With a goal to assess the rates of bacterial contamination and identify possible common factors among positive samples, FDA is conducting large-scale samplings of fresh cilantro, parsley, basil, and processed avocado and guacamole. To sample for certain microbial contaminants, FDA began the process in October 2017 with plans to collect 1,600 samples for each of the three groups of food products, estimating sampling to last about 18 months. So, if you import, process or store fresh cilantro, parsley, basil or avocado products, your product may become a part of this study. FDA is collecting import samples from ports of entry, importer warehouses, or other storage facilities where foreign goods are cleared for entry into the country. Domestic samples of the fresh herbs are being collected from packers (including post-harvest products in packinghouses on farms), wholesalers, distributors, warehouses and retail (from dealer storage prior to consumer handling). Domestic samples of processed avocado products are being collected from processors, distributors, and retail locations. While noting that conclusions about overall contamination rates can’t be made until all the data are collected, validated, and analyzed, FDA said that as of January 1, 2018, it had collected: 35 domestic samples (4.6%) of fresh herbs, none of which tested positive 104 import samples (12.4%) of fresh herbs; 4 tested positive for Salmonella; 3 for Shiga toxin-producing E. coli; and none for E. coli 0157:H7. 58 domestic samples (7.3%) of processed avocado/guacamole; 3 tested positive for Listeria monocytogenes. 49 import samples (6.1%) of processed avocado/guacamole; 1 tested positive for Listeria monocytogenes. The sampled herbs and product found to positive and capable of causing disease were voluntarily recalled if domestic product and denied entry into the U.S. if imported. Cilantro, parsley, basil FDA chose to sample these fresh herbs because they are grown low to the ground, thereby susceptible to contamination (e.g., from irrigation water splashing off the soil); are typically eaten without having undergone a kill step, such as cooking; and are often eaten as part of multi-ingredient foods so people may not report having eaten them when they became ill. Frozen, frozen, chopped, or dried herbs, and fresh herbs indicated as intended for processing will not be collected as part of the study. Even with an expected lack of consumer reporting, there were 9 foodborne outbreaks linked to basil, parsley and cilantro from 1996 to 2015, resulting in 2,699 illnesses and 84 hospitalizations. Seven of the outbreaks were attributed to Cyclospora cayetanensis; 1 to E. coli O157:H7; and 1 to Shigella sonnei. Thus, FDA is testing the herbs for Salmonella and Shiga toxin-producing E. coli (STEC) to obtain baseline estimates prevalence; it also will test for Cyclospora cayetanensis during the summer, when related illnesses typically occur. Processed Avocado/Guacamole Similarly, processed avocado products and refrigerated or frozen fresh-cut avocado may be packaged and eaten without having undergone a kill step. Because avocadoes have a high moisture content and a non-acidic pH level, they can support the growth of harmful bacteria. Thus, FDA is sampling fresh cut, pureed, refrigerated and frozen product, frozen avocado pulp with additives, and guacamole. Whole avocados (intact, with skin) will not be sampled, and FDA will not collect samples from farms or growers, product indicated as intended for beverage(s), or product indicated to have undergone a pathogen reduction step, such as pasteurization. CDC reported 12 outbreaks of foodborne illness related to avocado, avocado products or guacamole products from 2005 to 2015. Of those, 9 involved Salmonella and 3 E. coli, resulting in 525 illnesses and 23 hospitalizations. Though no Listeria outbreaks were reported during that time, a recent FDA sampling of avocado pulp and skin detected Listeria monocytogenes. Thus, the agency is seeking data on the prevalence of Salmonella and Listeria monocytogenes in processed avocado and products. With a goal to collect 1,600 samples of each grouping, FDA began sampling in October 2016 and expects to continue for 18 months, primarily on Mondays through Thursdays. The Agency will post quarterly results as well as a comprehensive report once sampling and analysis is complete. Just as for regular inspections, don’t expect to be notified that FDA will be sampling your product. And, similarly, if a positive is found, action likely will be taken, such as placing a firm on import alert, pushing for a recall, or issuing public warnings. It also is important to note that FDA will be using whole genome sequence (WGS) testing on any samples that test positive to obtain the genetic “fingerprint” of the pathogen. This information will then be added to its databases, enabling it to link past, present, or future human illnesses with potential food sources. Overall, this is another example of being aware of where FDA is focused on testing. and to take all the necessary precautions to reduce the likelihood that you will find yourself on the wrong end of a regulatory action. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
