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For many years, spices have been known to be a high-risk food in relation to the likelihood of microbial contamination. In a simplistic way spices are used by both manufacturers and are sold directly at retail. FDA has been paying close attention to spices for some time, and in a 2013 risk profile, FDA found spices to have an estimated 6.6% Salmonella prevalence rate at import into the U.S. However, the agency was not able to attain data on the level of contamination of spices at retail, even though it had requested such information from the public. That missing data piece is important because there was nothing to indicate that the contamination level was that high at retail, but FDA wanted to be able to evaluate the true risk to consumers. So, to fill in the data gap, the agency conducted a two-year nationwide study with which it has now provided an updated 2017 risk profile on spices. The 2013 draft risk profile also determined that the presence of pathogens, such as Salmonella, and filth in spices is a systemic challenge and that the problem relates in part to poor or inconsistent use of appropriate controls to prevent contamination. So, in addition to identifying critical data gaps and research needs, the objectives of the 2017 risk profile were to describe the nature and extent of the public health risk posed by consumption of spices in the U.S. by identifying the most commonly occurring microbial hazards and filth in spice; describe and evaluate current mitigation and control options designed to reduce the public health risk posed by consumption of contaminated spices in the U.S.; and identify potential additional mitigation and control options. For the study, FDA collected data on the presence of Salmonella in retail packages that you would find in supermarkets, ethnic markets, discount stores, and on the internet. The results: Except for dehydrated garlic and basil (for which statistical power was limited), Salmonella prevalence was found to be significantly lower in retail samples than its estimated prevalence at import. FDA noted that the reduction is consistent with manufacturer comment that they apply a pathogen reduction treatment to many spices after entering the U.S., prior to retail sale. The following table provides a comparison of the two. (FDA’s 6.6% rate is not a direct correlation of this because its calculation includes number of samples and confidence rate.) Samples for FDA’s retail spice sampling survey were collected at a variety of retail establishments throughout the U.S. between November 2013-September 2014 or October 2014-March 2015. Spice shipments from 79 countries were examined for Salmonella; of these, 37 had Salmonella-contaminated shipments, indicating that this contamination is not limited to just a few source countries. The overall prevalence of approximately 6.6% during the 2007 to 2009 fiscal years is about twice the average prevalence of all other imported, FDA-regulated foods. FDA also found that approximately 12% of the spice shipments offered for entry to the U.S. during a three-year period (FY 2007 to FY 2009) were adulterated with filth such as insects and animal hair, which can result from inadequate manufacturing, packing or storage conditions. In discussing the steps it is taking to improve the safety of spices, FDA cited FSMA as helping in improvement, because the rules, which address domestic and imported foods, focus on preventing hazards and on tightening controls in the supply chain. FDA gave the preventive controls rule as an example, as it requires food facilities, including those that manufacture spices, to conduct a hazard analysis, identify hazards reasonably likely to occur, and establish preventive controls for such hazards. Additionally, the foreign supplier verification rule requires that importers also conduct a hazard analysis and ensure that preventive controls are in place and verify that the foods they import are produced using processes and procedures that ensure the same level of safety as food produced in the U.S.; produce safety requirements may apply to certain types of spice source plants. In addition, FDA stated: In recent years, it has increased its inspections of spice manufacturing facilities. It works closely with its partners in other countries to share information on ways to improve spice safety. It has staff permanently stationed in China, India, Europe, Latin America, Middle East and North Africa, and Sub-Saharan Africa; with two offices in India. It is working with several partners to develop a training center focused on supply chain management for spices and botanical ingredients, with a goal of establishing a cadre of in-country experts who can offer training in all aspects of food safety management throughout the supply chain. FDA scientists also will participate in the newly formed Codex Committee on Spices and Culinary Herbs. The key findings from the study were published as a peer-reviewed scientific journal article entitled, “Prevalence of Salmonella in eleven spices offered for sale from retail establishments and in imported shipments offered for entry to the United States.” As noted above, spices have been a notorious source of microbiological problems for many years. While the data that FDA has recently shared does show that spices at retail are safer than imports, the prevalence of microbial contamination is still pretty scary – with close to 1 in 200 retail samples of ground coriander, ground red pepper, and dehydrated garlic positive for Salmonella at retail. I see four very important messages from this work. First, FDA is still focused on spices, so if you are a spice user or seller watch out. Second, despite interventions, the levels of microbial contamination at retail are still concerning in some products; and in today’s environment of whole genome sequencing, this could impact you as a source if you are selling spice at retail. Third, if you are using spices on finished goods that are RTE without a further kill step, you are playing with fire around risks of microbial contamination. Four, this is clear data that spices are risky and FDA will expect you to have preventive controls with regard to FSMA compliance. 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

If You Use or Sell Spices Watch Out! FDA Radar for Preventive Controls