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In July’s FSMA Friday webinar, sponsored by SafetyChain, TAG Director of Food Safety Anabelle Broadbent discussed Food Safety of Sprouts: Understanding and Implementing the Requirements of FSMA’s Produce Safety Rule. The Produce Safety Rule (21 CFR 112) establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption with any operations conducting these activities for produce, including sprouts, are considered to be farms and are subject to the rule. However, sprouts present a unique risk because the conditions under which they are typically produced are also ideal for the growth of bacteria that cause foodborne illnesses, so FSMA includes additional requirements and separate compliance dates for sprout operations under Subpart M. In addition to the sprout germination conditions that encourage the proliferation of pathogens (including temperature, time, nutrients present, etc.), sprouts have increased risk in that the seeds can be contaminated on the farm and the sprouts contaminated during production. In fact, in the many well-documented sprout outbreaks and recalls of recent years (at least 50 outbreaks in the past two decades), the most likely source of contamination has been the seed, with Salmonella and pathogenic E. coli responsible for the majority of outbreaks, while Listeria monocytogenes also has been implicated. Thus, FSMA requires that sprout operations follow very specific requirements for seeds, including type and method of treatment. Other critical areas for the control of potential microbial contamination include: the sprout production environment, building infrastructure, equipment, and other sources and niches of potential contamination; sanitation management; sampling and testing of spent irrigation water; environmental monitoring for Listeria; and recordkeeping. And even with the various compliance dates based on business size, the final date for very small operations was January 28, 2019, so all sprout operations are to now be in compliance with the rule. Like most businesses, food sprout-producing companies, particularly very small business, don’t have unlimited resources and need to work within a budget. To optimize the money, time, and resources to get the most value for their investments, there are some critical steps sprout businesses can take, including: Take the time to identify food safety risks and practices in the facility and ways to reduce those risks. Prioritize the implementation of sprout production food safety practices to use limited resources wisely. Understand the food safety hazards associated with sprout production, including the types of associated pathogens and the factors that influence their opportunity to outgrow the native microflora. Understand the requirements of the Produce Safety Rule. Learn about implementing best practices to prevent sprout contamination Additionally, to best overcome the risks and complexities of sprout production, there are two main things that a sprout-grower should assess: the hygienic sprout production environment and specific risk-reduction measures. The environmental focus needs to include cleaning and sanitizing of both the infrastructure and equipment, as well as that of employee health and hygiene practices to reduce contamination from either. As such, Good Manufacturing Practices (GMPs) are extremely important in sprout operations – from beginning to end: from seed to germination to water source to handling, you need to ensure GMPs are being followed and you’re doing everything possible to mitigate risk. As focused on risk reduction measures for sprouts, it starts with the purchase of safe seed from a reputable source; its subsequent receiving and storage; and the use of safe, quality water. From there, it is critical to determine the best seed treatment (e.g., chemical, physical, or biological) to kill or significantly reduce potential microbial contaminants that may be associated with the seed. Following that is the verification of control measures that ensure the effectiveness of your sanitation processes, testing of the spent irrigation water and sprouts as part of a hold and release program, and conducting environmental monitoring for Listeria. Included in the presentation were a number of treatment options including those that have been evaluated at a pilot- or commercial scale; other peer reviewed, published treatments that have shown comparable effectiveness as 20,000 ppm calcium hypochlorite treatment; and validated test kits for microbial testing of spent irrigation water during sprout production. For the complete listing of these and their references, see slides 13 through 15 in the slide deck or the full presentation. On June 25th, as part of its increased focus on prevention rather than response, FDA released a draft guidance designed to improve the safety of fresh sprouts, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting.” FDA used international and domestic best practices data to develop the guidance, which includes suggested practices. If entities wish to follow other procedures, they must document that those processes are as effective as those in the guidance. The guidance applies to all entities in the food supply chain, from seed producers through distributors as well as those who grow and sell fresh sprouts, stating that if a grower, holder, conditioner, or distributor “reasonably believes that its seeds are expected to be used for sprouting, we recommend that the grower, holder, conditioner, or distributor take steps that are reasonably necessary to prevent those seeds from becoming contaminated.” FDA is accepting comments from the public, businesses, academia and all other interested parties. Comments can be submitted online, by fax, by personal courier or regular mail; the 60-day comment period ends August 26. 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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