Inspections, Compliance, Enforcement, and Criminal Investigations
Blue Marine Seafoods Trading 11/9/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
- You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points (CCPs) to comply with 21 CFR 123.6(c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for your frozen tuna products does not list the following critical control points for controlling the food safety hazards of histamine formation and pathogen growth in fish intended for raw consumption:
- A processing CCP to control excessive histamine formation and pathogen growth.
- A pre-chilling CCP to control pathogen growth and histamine formation.
- A (b)(4) CCP to control Clostridium botulinum toxin formation and histamine formation. (b)(4) pose a hazard for Clostridium botulinum growth and toxin formation because they are conducted for an extended time period under anaerobic conditions. Consequently, once your HACCP plan has been revised to include a critical control point for the (b)(4) and/or the (b)(4), your HACCP plan needs to include adequate critical limits. Specifically, your plan needs to ensure that temperatures are maintained below 3.3° C for the duration of the (b)(4) to control toxin formation. Additionally, FDA recommends that firms use equipment capable of continuously monitoring and recording the temperatures for the entire duration of the (b)(4).
- (b)(4) CCPs to control Clostridium botulinum toxin formation, pathogen growth and histamine formation
- A (b)(4) CCP to control Clostridium botulinum toxin formation during those instances where there is an accumulation of product prior to freezing. Your processing records suggest that product is accumulated prior to freezing, subsequent to (b)(4). Consequently, the product should be maintained below 38°F (3.3°C) until it is (b)(4).
- You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for your frozen tuna products does not list a critical limit at the Receiving critical control point adequate to control histamine formation.
a. As a primary processor receiving the fish directly from the harvest vessels, your firm needs to include critical limits at receiving associated with sensory evaluation to monitor for decomposition, in addition to the listed critical limits associated with harvest vessel records and internal/backbone temperatures. FDA recommends conducting sensory evaluation on a minimum of 118 fish in each lot (i.e., each harvest vessel) or on all fish when the lots consists of less than 118 fish; and accepting the lot when less than 2.5% of the fish in the lot exhibit persistent odors or indicators of decomposition. Individual fish that exhibit persistent odors of decomposition should be rejected.
- You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for your frozen tuna products lists monitoring procedures/frequencies at the following critical control points that are not adequate to control histamine formation and pathogen growth for fish intended for raw consumption.
- The Receiving critical control point lists a monitoring procedure/frequency of “(b)(4)” that is not adequate because it does not specify that monitoring will be conducted at the wharf at the time of off-loading from the boats. This monitoring activity is intended to demonstrate adequate chilling of the fish while onboard the boats. Consequently, the temperatures need to be taken at the wharf, before the fish are loaded onto the vans for transit to your facility.
- The “(b)(4)” critical control point lists a monitoring procedure/frequency (b)(4) that is not adequate because it does not address control of temperatures between those (b)(4). FDA recommends the use of equipment capable of continuously monitoring and recording temperatures for the entire duration of the chilling/curing time period, instead of (b)(4).
- The listed critical limits associated with harvest vessel records in your HACCP plan do not include the necessary monitoring parameters associated with the harvest vessel record strategy, to ensure that the fish were properly handled onboard the vessels. For example, your plan does not list that the harvest vessel records will include the following:
- Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans are not appropriate, as follows:
- The “(b)(4)” critical control points do not include product disposition or address any actions to correct the cause of the deviation such as correcting chiller problems or identifying other causes for failure to meet the critical limit. In addition, the corrective action should include holding the product and evaluating the cumulative time and temperature exposures.
- The “(b)(4)” critical control does not include steps to correct the cause of the deviation, such as communication back to the supplier or discontinuation of use of the supplier and does not clearly define when corrections are to be taken. (b)(4) of the fish is listed as a corrective action when backbone temperature is (b)(4) is not defined.