The seafood and juice industry largely sat on the sidelines while FDA worked with the rest of the food industry to develop the recently finalized Hazard Analysis, Risk-based Preventive Controls (alternatively known as HARPC, Preventive Controls Rule, or PC Rule). This ambivalence came from the statutory provision within the Food Safety Modernization Act (FSMA) that exempts seafood and juice facilities from HARPC if they are complying with the HACCP regulations.
However, FDA did more than create HARPC regulations; it also took the opportunity to update the current Good Manufacturing Practice (cGMP) regulations. cGMP regulations apply to seafood and juice facilities. Two aspects stand out in particular: (1) training and recordkeeping for employee sanitary practices, and (2) avoiding cross-contact contamination with major food allergens.
Training and Recordkeeping:
Historically, cGMPs did not require facilities to maintain records verifying compliance with the regulations. Originally, the regulations required that “food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles.” 21 C.F.R. 110.10(c). Unsurprisingly, FDA changed the “should” to a “must” for training about “food hygiene and food safety.” 21 C.F.R. 117.4(b)(2).
The Agency went one step further, requiring facilities to establish and maintain records that the employee received this training. 21 C.F.R. 117.9(a). While many facilities may currently be doing this, many others are not – or at least, not maintaining records. This change makes failing to create/maintain records a violation of the law (as compared to not following a best-in-class practice). So all facilities need to review their practices and modify accordingly.
Allergen Cross-Contact:
Throughout the revised cGMPs, FDA requires facilities to protect against contamination of major food allergens caused by cross-contact (this is separate from the HACCP obligation to ensure that all added major food allergens are properly declared on the label). Although part of the cGMP obligation, in the comments FDA frequently considered that facilities would implement preventive controls under their HARPC plan to address the concern.
This is not an adequate approach for seafood and juice facilities, as they are exempt from HARPC. Presumably, the concern does not reach the level of a critical control point, as this does not follow the historic approach and guidance (although it could in theory). FDA might argue that this concern becomes part of the Sanitation Control Procedure, as the risk would possibly be caused by cross-contamination of a food contact surface. However, the regulation does not explicitly include allergen cross-contact in its list of concerns. Thus, it remains unseen how FDA would expect a seafood or juice facility to address this requirement.
These two examples highlight how the new HARPC rule affects the seafood and juice industry. These industries should remain vigilant as FDA implements HARPC, as it will also affect how FDA interprets and enforces the HACCP rule.
Many seafood and juice industry members rely on FDAImports.com to keep their cGMP practices up-to-date. See our video below for more information and Contact us if you have questions.
