If you are a seafood or juice producer who is subject to and implements all HACCP requirements, you’ve probably questioned the applicability of the FSMA rules to your operations. For some in the Juice and Seafood space there was a sense that “FSMA does not apply to me,” but with its focus on FDA’s recently published guidance documents on Juice HACCP and FSMA, and Seafood HACCP and FSMA, this newsletter will answer many of your questions related to compliance and exemptions, as it is clear that certain parts of FSMA do apply to you if you are in the Juice or Seafood industry. As discussed in last week’s newsletter focused on LACF and FSMA, with the understanding of that the HACCP rules were in place long before FSMA 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. Additionally, it is important to reiterate that these are important guidelines because companies who are operating under the HACCP rules may think they are simply exempt from FSMA requirements. But these new guidelines make it very clear that you are not fully exempt and you need to pay attention to those parts of FSMA that do apply. So, what does FDA say you are responsible for and exempt from in FSMA? Overall, the cGMP requirements generally align with the requirements of HACCP, with some exceptions and clarifications, including: Training. In addition to HACCP requirements, facility management is responsible for ensuring that employees meet the training requirements of the PC rule. Applicable workers (including temporary and seasonal personnel) must be “qualified individuals,” that is, have the education, training, and/or experience necessary to perform their duties and receive training in the principles of food hygiene and food safety. Supervisory personnel must have the education, training, and/or experience to supervise the production of clean and safe food. Records of the training are to be maintained. Allergens. Juice processors are to address allergens through the application of cGMPs which mandate that personnel, plant equipment and utensils, and other activities must not lead to allergen cross-contact. The juice HACCP regulation requires that a juice processor consider the presence of undeclared ingredients that may be food allergens as part of its hazard analysis and several sections in the new guidance also make recommendations for the control of food allergens.
The seafood HACCP regulation requires processors to address all seafood safety hazards identified by the hazard analysis in their HACCP plan and to comply with part 110 or part 117 (as relevant). FDA also intends to provide separate guidance regarding control of allergen cross-contact by seafood processors. Written Sanitation Procedures. Juice and seafood processors are exempt from the written sanitation procedures requirement of the preventive controls rule. However, sanitation controls would need to be written if applicable and processors are required to implement sanitation monitoring procedures and to maintain these records of the monitoring and any corrections. HARPC. HACCP-complying juice and seafood processors are also exempt from the HARPC and from the requirement to establish written recall plans for food with a hazard requiring a preventative control.
However non-juice raw materials and ingredients that are part of a 100 percent juice product (thus subject to the juice HACCP regulation) must be evaluated for hazards in the hazard analysis and controlled for in the HACCP plan; seafood processors must consider both fish and non-fish raw materials and ingredients in their hazard analyses, and address any reasonably likely food safety hazards in their HACCP plan. Supplier Controls. Juice and seafood processors are exempt from the Supply-Chain Program provisions of the rule, except for the records requirement. Dual Production. However, if a facility manufactures, processes, packs, or holds both exempt and non-exempt products, the activities that apply to non-exempt products and their raw materials or ingredients must meet the requirements of the Preventive Controls rule (including the HARPC and supply chain provisions) unless an exemption applies. This applies to both juice and seafood manufacturers. Environmental Monitoring. Juice processors in compliance with HACCP are exempt from environmental monitoring through the testing of environmental samples. (Environmental monitoring was not mentioned in the seafood guidance, however both seafood and juice processors must implement sanitation monitoring procedures and to maintain written sanitation monitoring and corrective action records as required by the HACCP.) Radiological hazards. Although radiological contamination of foods is rare, seafood processors need to consider these hazards under some circumstances, such as accidental release from or damage to a nuclear facility. Thus, the HACCP plan must list the necessary CCPs and preventive controls in the hazard analysis if a radiological hazard is identified as reasonably likely. Recordkeeping. Seafood and juice processors are not required to comply with FSMA recordkeeping rules, except those for training and those established by the HACCP requirements. FSVP. Juice and seafood importers are exempt from the FSVP regulation, provided that product is imported from a foreign supplier that is required to comply with, and is in compliance with the FSMA rule.
However, because the FSVP regulation requires all importers subject to that rule to identify themselves as the FSVP importer upon entry, all food imports will be prompted for a data code at entry. Seafood and juice importers should, thus, transmit the Affirmation of Compliance code, “FSX” (designating the exemption), for each entry. Without a code, the entry will be rejected, and an incorrect code could result in the importer being listed in the FSVP inventory for inspection. Produce Safety Rule. Juice processors are not required to purchase product that complies with the Produce Safety Rule because produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (e.g., HACCP) is eligible for an exemption However, the farmer’s documentation must disclose that the food is “not processed to adequately reduce the presence of microorganisms of public health significance” and obtain written assurance of this annually from the customer (e.g., the juice processor). Accreditation of Third-Party Certification Bodies. Seafood importers need to have and implement written verification procedures if the importer obtains a certification from an accredited Third-Party Certification Body under the requirements of the Third-Party Certification Program. Food Defense. Domestic and foreign juice and seafood processors required to register with FDA must comply with the Intentional Adulteration rule unless an exemption applies to the facility (e.g., it is a very small business, only holds food, is a farm subject to the Produce Safety Rule, produces only food for animals, etc.) Sanitary Transportation. Food completely enclosed by a container is not subject to this regulation unless the food requires temperature control for safety. For example, the transportation of pasteurized acidic fruit juice (pH 4.6 or less) packaged in a sealed container is not subject to this regulation because the juice may spoil but not become unsafe if temperature control is not maintained.
Seafood processors, however, are subject to the regulation when they are engaged in transportation operations for food that is not excluded, such as seafood that requires temperature control for safety. The transportation of a shelf-stable seafood product completely enclosed by a container is not. So as you can see there actually is quite a bit of FSMA to keep in mind if you are under either juice or seafood HACCP. Even though much of the Preventive control rule does not apply, both the food defense rule and the sanitary transport rule apply to you as written. If you need help to figure out what to do let us know at TAG and we can help. 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
