FDA Guidances for Bridging FSMA with Seafood HACCP, Juice HACCP, and LACF

The biggest impact with FSMA on juice, seafood, and LACF processors is the requirement for employees and supervisor personnel (1) be a qualified individual as defined in 21 CFR 117.3, i.e., have the combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties (21 CFR 117.4(b)(1)); and (2) receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility, and the individual’s assigned duties (21 CFR 117.4(b)(2)).  So training of employees and managers is required, with the appropriate documentation to demonstrate that.
FDA issued guidance for seafood firms on the requirements that need to be followed with regard to FSMA.  This guidance, Seafood HACCP and the FDA Food Safety Modernization Act: Guidance for Industry, basically say that seafood firms can use their HACCP plans as required in 21CFR123 and do not have to comply with the new Preventive Control requirements (part C and G) of the new regulation (21CFR117).  Parts A and B (GMPs) do apply with one specific requirement for training of employees and management (for them to become 'qualified').

Juice is essentially the same with regard to HACCP and Preventive Controls. As long as you comply with HACCP regulations, then you do not have to worry about part C and G of 21CFR117.

Manufacturers of low-acid canned foods must meet the requirements of specific subparts of the CGMP& PC Regulation. The exemption in 21 CFR 117.5(d) of subpart A applies to the activities that are subject to 21 CFR part 113. 21 CFR 117.5(d) specifically exempts the processing activities of processors of low-acid canned foods from the requirements of part 117 subpart C, Hazard Analysis and Risk-Based Preventive Controls, and subpart G, Supply-Chain Program for biological hazards and their controls, if the processor of low-acid canned foods is in compliance with 21 CFR part 113. Low-acid canned food processors still must meet the requirements of part 117 subparts A, B, and F (for the records required by subpart A). In contrast to manufacturers of low-acid canned foods, food processors subject to 21 CFR part 114, Acidified Foods, are not specifically exempt from any provisions of 21 CFR part 117 and must comply with all applicable sections.

Processors, regardless of what they are processing, must comply with rules for protecting against intentional contamination (food defense) and sanitary transport.

FDA Constituent update
https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm569554.htm

August 7, 2017

If you are a food producer covered by FDA’s regulations for low-acid canned foods, juice HACCP, or seafood HACCP, how do the rules that implement the FDA Food Safety Modernization Act (FSMA) affect you?

To answer this question, the FDA has published three guidances to help producers of food commodities covered by these earlier regulations understand which parts of the FSMA rules apply to them and how the FSMA rules may affect their operations.

FDA’s HACCP (Hazard Analysis and Critical Control Point) and Low-Acid Canned Foods (LACF) regulations were in place long before the FSMA rules became final.  FDA’s HACCP regulations for juice and seafood processors  require  processors to perform a hazard analysis and develop a HACCP plan to address biological, chemical, and physical hazards, monitor the conditions and practices, and make corrections as needed. FDA’s Low-acid canned foods regulation addresses biological hazards such as Clostridium botulinum unique to such foods, which include canned vegetables.

FSMA recognizes that FDA has previously-established regulations that are specific to seafood, juice, and LACF and so some exemptions have been made in the FSMA rules for these products. However, there are still some requirements in the FSMA regulations that apply to processors of the seafood, juice, and LACF products.

The new guidances aim to help industry identify these exemptions and understand the juice, seafood, and LACF regulations in connection with some of the new FSMA requirements. The overarching goal of many of the new FSMA  requirements is to reduce the number of foodborne illnesses attributed to the preventable contamination of FDA-regulated food products.

For More Information
•Low-Acid Canned Foods and FSMA
•Juice HACCP and FSMA
•Seafood HACCP  and FSMA