DA has issued updated draft guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods,” intended for ready-to-eat food (RTE) facilities subject to FSMA’s Preventive Controls rule. Although the emphasis on prevention in the draft guidance is consistent with FSMA’s hazard analysis and risk-based preventive controls (HARPC) and cGMPs, FDA says it will be beneficial to all facilities whether they are subject to only CGMPs, preventive controls, or both. The guidance is long and comprehensive and makes some very clear recommendations, some of which are going to be tough to implement (like regular zone 1 testing during production runs). There is a lot to talk about with the guidance, so we are going to take it in pieces over the next few newsletters. Appropriately, FDA makes it clear that you have to begin with all the correct controls that are based on risk. Second you need to implement the controls, check that they are working with a solid environmental monitoring program, and finally take the appropriate action when you find a positive result. And of course, keep records of all these processes as you go. RTE facilities which manufacture, process, pack, or hold foods subject to both FDA and USDA regulation will be happy to know that the guidance is providing a uniform federal approach to the control of Listeria monocytogenes (Lm) by integrating the “seek and destroy” approach used by USDA’s Food Safety and Inspection Service (FSIS) with the FSMA requirements. Providing this uniform federal approach, FDA feels should lead to more effective efforts to control Lmin RTE products. The draft guidance focuses on industry best practices, and includes recommendations for controls involving personnel, sanitation, and cleaning and maintenance of equipment. Its primary purpose is to provide guidance on measures that can significantly minimize or prevent the contamination of RTE food with Lm whenever an RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or have a control measure that would significantly minimize Lm. FDA emphasizes that the guidance is not directed to processors of RTE foods that have a listericidal control applied in the foods’ final package or just prior to packaging – as long as it has a system that shields the food and food-contact surfaces of the packaging from environmental contamination. Nor is it intended for farms or other operations not subject to the Preventive Controls for Human Food (PCHF) rule. Again raising the important question, from a regulatory aspect, for some, of “Am I a farm or am I a processing facility?” It also is important to note that some parts of the guidance discuss “recommendations” for actions that are “requirements” of PCHF. This is, essentially for simplicity, it does not exclude the need for facilities to comply with PCHF requirements. Additionally, the recommendations are intended to complement the recommendations of other guidance documents; they do no supersede them. The Agency provides the example that a facility which processes seafood for use as sushi should follow the Fish/Fishery HACCP guidance. As noted above, the guidance begins with a focus on controls and the following is a summary of the areas where FDA makes recommendations for controls. I recommend you go over this list and make sure you have thought about all of these things: Personnel. Because people’s actions can transfer Lm from the processing environment to RTE food, the guidance includes recommendations for hands, gloves and footwear; foamers, footbaths, and dry powdered sanitizers; clothing; and controls on personnel who are associated with specific areas in the plant and those who perform sanitation, maintenance, and similar functions. Plant Design and Construction. As required by CGMPs, the food facilities’ structures are to be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food production purposes. As such, the guidance includes general design and construction of the plant along with those for water systems and air and air flow. Plant Operations. Includes recommendations for traffic flow patterns for personnel, food products, food packaging materials, and equipment and management of pallets, totes and other containers, continuous use brines and recycled process water, aerosols, compressed gases or air (used directly in or on RTE food or food-contact surfaces), and the water supply and any treatment systems Equipment Design and Construction. With the PCHF rule requiring that equipment and utensils be designed and of material and workmanship as to be adequately cleanable, the guidance recommends that the RTE production equipment be designed and constructed to minimize sites where microbial harborage and multiplication can occur, with specifications for food-contact surfaces, including conveyors; catwalk framework, table legs, conveyor rollers, and racks; catwalk and stair positioning; floor drains; wheeled devices; condensate; hoses; heat exchangers. Equipment Maintenance. A preventive maintenance program should be designed to minimize breakdowns and prevent contamination that could occur during repair of equipment. Also included are recommendations for use of dedicated tools, filter changing, and record maintenance. Sanitation. Food facilities are to establish and use a sanitation program that includes written sanitation procedures and a schedule for areas where RTE foods or food contact surfaces are processed or exposed. Includes recommendations for CIP systems; wet cleaning and sanitizing; production line cleaning where another line is operating; assembly of cleaned and sanitized equipment; equipment and utensils used for cleaning/sanitizing; drain cleaning; sanitizer efficacy; sanitation monitoring; and recordkeeping. Raw materials and Ingredients. Facilities should assess which raw materials and other ingredients are more likely to be contaminated with Lm and focus control efforts on these. Additionally: verify that any suppliers with listericidal control measures have validated the process and have ongoing monitoring and verification programs. Recommendations are specified for listericidical control measures, supplier controls, applicability of incoming goods testing, recordkeeping Formulation controls. Formulating food product to have one or more intrinsic characteristic (physical or chemical) can enhance product safety. This should include initial validation; ongoing monitoring and verification; corrective action/correction; and recordkeeping. Process Controls. Consider the practicality of including a listericidal process control in the manufacturing process, with demonstration that any such controls are effective and verified on an ongoing basis. Include initial validation; monitoring and verification; corrective action/correction; and recordkeeping. Storage Practices and Time/Temperature Controls. The guidance recommends the establishment and implementation of procedures to minimize the potential for an increase in numbers of any Lm that could be present. Transportation. Trailers and tankers should be inspected and include time/temperature controls; tankers/repeat-use bulk containers should be dedicated to the RTE product or PC procedures established. Follow all Transportation rule requirements. The guidance also includes detailed recommendations for facilities’ Environmental Control and Monitoring program as well as sampling and testing and the use of trend analysis. However, because these are in-depth, and an area of great concern to the industry, we will dedicate next week’s newsletter to a more complete discussion of this part of the guidance. As a final comment, it is very helpful for us all to now have the FDA guidance document. It is both helpful and scary in terms of the way FDA has now set clear expectations, which, for some, will be a heavy lift. But if you were hoping for FDA to “let you off the hook” with your first zone 1 positive in a RTE food, you will be disappointed. But more on that in future newsletters. FDA is accepting comments on the draft guidance through July 17 at www.regulations.gov, search FDA-2008-D-0096. 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
