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  • FDA Clarifies FSMA Exemptions for LACF, Juice, and Seafood

Because FDA’s Low-Acid Canned Foods (LACF), Juice and Seafood HACCP rules were in place long before the finalization of FSMA rules and cover many regulatory similarities more directly related to these foods, FDA has published new guidance explaining the provisions of FSMA for which manufacturers or processors of these foods are exempt or must comply. These are important guidelines for those operating in any of these three areas. Some companies who are, for example, operating under the Juice HACCP rule, may think they are simply exempt from FSMA requirements. These new guidelines make it very clear that such entities are not fully exempt and they need to pay attention to those parts of FSMA that do apply to them. Each of the three guidance documents, Low-Acid Canned Foods and FSMA, Juice HACCP and FSMA, and Seafood HACCP and FSMA details the relationship of the LACF/HACCP rules with five of the seven major rules of FSMA (leaving off the Preventive Controls for Animals and Accredited Third Party Certification rules as not applicable). In this newsletter, we address the key requirements and exemptions for LACF producers; we will follow up next week to detail the Juice and Seafood HACCP compliance and exemption guidance. The overarching goal of many of the FSMA requirements is to reduce the number of foodborne illnesses attributed to the preventable contamination of FDA-regulated food products, but FDA recognizes that it previously established a regulation that addresses biological hazards unique to low-acid foods packaged in hermetically sealed containers (i.e., low-acid canned foods, LACF). Thus the LACF and FSMA Guidance addresses the following compliance requirements and exemptions. In relation to the Preventive Controls rule, LACF manufacturers Are exempt from its Hazard Analysis and Risk-Based Preventive Controls and Supply Chain Program for biological hazards and their controls, if the processor is in compliance with 21 CFR part 113 for low-acid canned food processors. However, if the manufacturer identifies chemical or physical hazards associated with incoming raw materials/ingredients with the hazards controlled by the supplier, the manufacturer is subject to the requirements for a supply-chain program. Must meet the general and cGMP provisions of the rule. The cGMPs are fairly closely aligned with the requirements of 21 CFR part 110, with the addition of explicit allergen cross-contact requirements. Allergens are to be addressed a hazard that must be addressed in the food safety plan, with preventive controls established if identified as a hazard. Must meet relevant recordkeeping provisions of the rule, including those for applicable preventive controls (physical and chemical hazards) and training. Must comply with the new training requirements that workers and supervisors be qualified individuals with the education, training, and/or experience necessary to conduct their assigned duties and receive training in the principles of food hygiene and food safety, as appropriate, with records of the food hygiene and food safety principles training maintained. Additionally, LACF manufacturers must follow the operating supervisor training requirements of the LACF regulation. Are exempts from the requirement for written sanitation controls for microbiological hazards, however sanitation controls may be required to prevent cross contact if the firm has identified food allergen hazards. Are not required to do environmental monitoring because they are exempt from subpart C with regard to microbiological hazards that are regulated under part 113. For the Foreign Supplier Verification Programs (FSVP) rule: Importers of LACF not subject to further manufacturing and processing, and subject to 21 CFR part 113, are subject to FSVP requirements. But, importers are not required to comply with the FSVP regulation for raw materials or other ingredients that it uses in LACF if the importer is in compliance with part 113. Additionally, the importer must have an FSVP for imported raw materials/ingredients it uses in LACF for all hazards other than microbiological hazards. That is, it must have an FSVP for associated chemical or physical hazards, but the FSVP does not need to address microbiological hazards that are controlled under part 113. The Produce Safety Rule: An LACF producer need not require that its produce providers be in compliance with the Produce Safety Rule because produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (e.g., the LACF rule) is exempt from the rule. However, the farmer must include written disclosure that the food is “not processed to adequately reduce the presence of microorganisms of public health significance” and obtain written assurance annually from the customer (e.g., the LACF operation) that the LACF producer (or its customer) is following procedures that adequately reduce the presence of microorganisms of public health significance. The Intentional Adulteration (IA) Rule: All LACF manufacturers required to register with FDA must comply with the IA rule, unless exempt as a very small business or other exemptions as identified in the rule. The Sanitary Transport Rule: Transportation of food completely enclosed by a container are not subject to this rule unless it requires temperature control for safety. Thus, LACFs packaged in hermetically sealed containers are exempt from this regulation. My take from these useful guidance documents is that FDA has add a lot of clarity to what they expect from firms operating under LACF regulatory requirements. While there are lot of important exemptions there are some key areas that need to be focused on for regulatory compliance as we have discussed above. 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

FDA Clarifies FSMA Exemptions for LACF, Juice, and Seafood