If you have included heat treatments in your FSMA Food Safety Plan as a preventive control – or think you may need to add it to your developed plan, FDA’s just-released draft guidance on “Use of Heat Treatments as a Process Control (Chapter 6 of the Hazard Analysis and Risk-Based Preventive Controls for Human Food (PCHF) draft guidance)” is meant for you. The purpose of the chapter is to explain how to establish and implement a heat treatment (e.g., baking or cooking) to prevent contamination by disease-causing bacteria. However, FDA explains that, heating is only one of the process controls a facility may choose because, while the heat treatments discussed in the chapter are designed to kill/destroy vegetative cells of bacterial pathogens (e.g., Salmonella), they are not adequate to inactivate spores of spore-forming bacteria (e.g., all strains of C. botulinum). Thus, facilities may need to implement additional preventive controls to control spores. Additionally, the heat treatments need to be properly designed and implemented, or pathogens could survive the process and cause illness. Another way of looking at this is that FDA expects each facility to understand the risks they need to control. Then FDA expects that those risks are controlled appropriately per your Food Safety Plan. This guidance document is designed to help, not to provide all the answers. As such, the process control(s) selected by a facility should be based on its hazard analysis, with other options being Time/Temperature Control, discussed in the guidance chapter 7; Formulation Control (e.g., water activity, pH, and chemical preservatives), chapter 8; Dehydration/Drying, chapter 9; and Sanitation Controls, chapter 10. However, none of these chapters have yet been published. Heat Treatments. The heat treatments are designed “to significantly minimize (eliminate or reduce to an acceptable level) vegetative cells of bacterial pathogens that may have been introduced into the food by raw materials or during processing steps that occur before the heat step.” Additionally, as required by the PCHF rule, the preventive controls need to be validated by a PCQI as adequate to control the hazard, which, for the control of bacterial pathogens with an adequate heat treatment. Thus, a facility should: Scientifically establish a heat treatment that will significantly minimize the target bacterial pathogens to acceptable levels; Design and operate the heat treatment equipment so that every unit of product receives at least the established minimum heat treatment; and Monitor the established process parameters to verify achievement of the scientifically established heat treatment (e.g., time and temperature). Process parameters and their critical limits can be based on scientific information, attained from a process authority that has knowledge applicable to the product, or established from studies that a process authority conducts. Examples of heat treatment process parameters include amount of time for the heat treatment; temperature of the heating medium; internal temperature of the product; final temperature of the product; particle size; depth of product on a conveyor belt; container size; product formulation; and other parameters determined by a process-authority study. As also required by the PCHF rule with few exceptions, the management of preventive controls is to include monitoring; corrective actions and corrections; and verification. Monitoring. As appropriate to the nature of the preventive control and its role in your food safety system, written procedures, including the frequency needed to ensure consistent implementation, are to be established for monitoring the preventive control. Thus, when a heat treatment is your preventive control and you have established its critical factors for the heat treatment, you would monitor those critical factors. However, there are some exceptions, such as when a process parameter is automatically controlled (e.g., a bar is placed at a specified height above a conveyor belt to ensure that the bed depth of product being heat treated cannot exceed its critical limit). The guidance goes on to detail how and how often to monitor batch heating equipment, continuous heating equipment. Monitoring can be conducted by a qualified person or an applicable device. Corrective Action. To comply with FSMA requirements for the establishment and implementation of written corrective action procedures, corrective action for heat treatment would describe the steps you will take when the procedure does not achieve the process-specified temperature or time or any other established critical limits. Examples FDA provides are continued heating of the product, extended heat cycles to compensate for a temperature drop, reprocessing of the product, increasing the temperature or time, chill and hold for evaluation and disposition determination, diverting the product (e.g., to non-RTE or animal food), destruction of product. Verification. Examples FDA provides for heat-treatment verification activities to comply with FSMA requirements are calibrating monitoring and verification devices prior to use; reviewing monitoring records to confirm time and temperature; taking additional non-routine measurements at monitoring points; verifying appropriateness of corrective actions, as needed; testing product for bacterial hazards. Recordkeeping. To fulfill FSMA recordkeeping requirements, heat-treatment records need to be maintained for monitoring activities of the established process parameters; corrective actions; and ongoing verification activities. FDA again adds examples for monitoring records specific to batch-heating and continuous-heating equipment. The guidance then goes into relevant examples – of cookies, soups and salsa. With this month’s compliance date for small business (September 18), the guidance can provide those businesses with a last-minute check to make sure they are on track for FSMA compliance.