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It should not be a surprise to anyone reading this that spices are high-risk ingredients.  Over the years we have seen numerous outbreaks and recalls linked to spices. Sometimes the issues are related to pathogens, especially Salmonella. But more recently, the problems have been due to allergens such as peanuts in cumin. Keeping track of spices is all the more complex because of the fact that most are grown in countries with unsophisticated food safety systems and are derived from numerous small operations. All of these factors make controlling risks in spice suppliers a real challenge. FDA is well aware of the food safety risks in spices and this has been a focus of the Agency for quite some time. Ever since the October 2013 release of its Draft Risk Profile on Pathogens and Filth in Spices, FDA has been addressing spice safety on several fronts to analyze and reduce the risks of foodborne illness from contaminated spices. Last week, the Agency issued a Q&A on the current status and findings of its analysis and related initiatives. The primary objectives of the draft risk profile were to identify the most common microbial hazards and filth in spices, evaluate current prevention and control strategies and provide additional options, and identify critical data gaps and research needs. While it was determined that the presence of pathogens, such as Salmonella, and filth in spices is a systemic challenge related, in part, to poor or inconsistent use of preventive controls, FDA also realized there was a lack of information about the level of contamination of spices at retail in the U.S. So, the Agency conducted a two-year, nationwide study on the presence of Salmonella in retail packages – both domestically produced and imported. The retail assessment is important because, although the risk profile showed that imported spices were twice as likely to be contaminated with Salmonella as were other FDA-regulated food imports, and 12% were adulterated with filth (e.g., insects and animal hair), many imported spices are treated after entry to the U.S. So retail sampling tells a more accurate story of consumer risk. The analysis of this sampling is still being conducted, but FDA hopes to be able to post the results as soon as possible. In the meantime, the Agency sees the implementation of FSMA as helping to improve spice safety because the rules focus on preventing hazards and on tightening controls in the supply chain. Additionally, the Q&A lists other steps FDA has taken to improve the safety of spices, including its: Increase in inspections of spice manufacturing facilities in recent years. Working closely with its partners in other countries to share information on ways to improve spice safety. Stationing of permanent staff in China, India, Europe, Latin America, Middle East and North Africa, and Sub-Saharan Africa, with two offices in India, which is the leading country of origin for U.S. spices. Work with several partners to develop a training center focused on supply chain management for spices and botanical ingredients, with a goal of establishing in-country training experts. Scientists participating in the newly formed Codex Committee on Spices and Culinary Herbs. Additionally, FDA Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg spoke at the February World Spice Congress in India about FSMA and the agency’s efforts to improve the safety of spices. As the regulations for spices evolve in the future, it is clear that FDA plans to use all the leverage it can with FSMA to reduce the risks in spices. As noted, there are aspects of the preventive control rules which will help a lot on that front. However, I wonder if FDA will use its authority to require certificates for high-risk foods to help reduce the risks of spices. This authority was granted to FDA when FSMA was signed into law in 2011, but so far they have not used it. But, with the finalization of the third-party audit rule, we now have a mechanism being set up that will establish the necessary procedures for auditors to go on site and do a regulatory audit of spice producers outside of the U.S. in order to issue the FDA certificate that the Agency could, then, demand in the future. If you are using spices as ingredients in your products, you should start to prepare for a little more regulatory intervention in your spice supply chain. Yes, you are going to have to check up on your suppliers if your suppliers are controlling the risks as part of your compliance with the preventive controls rule.  But FDA is clearly making noise about its focus on the risks associated with spices, and I think it is only a matter of time before the Agency comes down fairly hard in this area of risk. Pathogens and Filth in Spices: What Are the Risks and What Is Being Done? by David Achesonis licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. 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.


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