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FDA Finds Contamination in Imported Spices, Identifies Current and Future Safety Efforts

Tuesday, November 05, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is inviting comments through Jan. 3, 2014, on a draft risk profile on pathogens and filth in spices that covers the period Oct. 1, 2006, through Sept. 30, 2009. This risk profile identifies the most commonly occurring microbial hazards and filth in spices and quantifies, where possible, the prevalence and levels of these adulterants at different points along the supply chain. It also identifies potential sources of contamination throughout the farm-to-table food safety continuum, evaluates the efficacy of current mitigation and control options designed to reduce the public health risk posed by consumption of contaminated spices in the U.S., describes potential new mitigation and control options, and identifies data gaps and research needs.

Contamination. The risk profile finds that imported spices, which make up the majority of those consumed in the U.S., tend to have a higher than normal occurrence of pathogens. Analysis of FDA sampling and testing data for shipments of imported spices offered for entry during the period of review revealed an average shipment prevalence for Salmonella of 6.6%, 1.9 times higher than for imports of all other FDA-regulated foods. When only considering imports of other FDA-regulated foods sampled with the same sampling protocol as that used for spices, the Salmonella prevalence for spices was 4.4 times higher. The FDA notes that some shipments reported to have been subjected to a pathogen reduction treatment before being offered for entry into the U.S. were found to be contaminated and that contaminated shipments were exported by many different countries.

Imported spices were also found to have higher concentrations of filth. FDA surveillance sampling data show that the average prevalence of filth adulteration of imported spices was 12%, 1.8 times higher than all other imported FDA-regulated food shipments. Nearly all of the insects found in spice samples were stored product pests, indicating inadequate packing or storage conditions. The FDA also states that the presence of these filth adulterants is indicative of unsanitary conditions and failures in the application of current good manufacturing practices.

Current Preventive Efforts. The FDA states that current U.S. regulatory mechanisms available to mitigate and control the adulteration of spices include current good manufacturing practices, inspections (which have increased in recent years) of and environmental sampling in spice manufacturing and packing facilities, product sampling, refusals and reconditioning, import alerts (with or without green lists and country agreements), and some provisions of the Food Safety Modernization Act. However, there was insufficient data to evaluate compliance with CGMPs in spice facilities outside the U.S., and no environmental sampling data were available to determine the prevalence of Salmonella in international spice facility environments. Entry was refused to 906 imported spice shipments during the period of review, most of them due to the presence or potential presence of Salmonella. The FDA accepted 50 out of 155 reconditioning proposals for spices, 37 of which addressed contamination with Salmonella. Other efforts include work by the FDA’s Center for Food Safety and Applied Nutrition with several partners to develop a training center focused on supply chain management for spices and botanical ingredients and proposed regulations under FSMA on preventive controls for human food facilities and foreign supplier verification programs for importers.

Five U.S. import alerts address the adulteration of spice by Salmonella or filth and four of these are specific to spice. One alert, for Indian black pepper, includes an agreement that leverages in-country regulatory authority to improve the safety of shipments offered for entry to the U.S. The FDA states that this combination of incentives appears to be effective in reducing the prevalence of contamination and that the expansion of this type of mechanism to other spices and/or countries should lead to further improvements in contamination rates.

Future Efforts. The risk profile concludes that failures in the food safety system potentially leading to adulteration of consumed spices generally arose from poor or inconsistent application of appropriate preventive controls, such as failing to limit animal access to the spice source plant during harvest or drying phases, failing to limit insect and rodent access to spices during storage, or failing to subject all spices to an effective pathogen reduction treatment or other lethality step. Potential future mitigations and control options that the FDA, the spice industry, government agencies, food manufacturers and preparers, and consumers may consider include capacity building, guidance, enforcement and regulatory strategies, communication, education and training to ensure understanding of appropriate preventive controls and how to implement them.

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