Inspections, Compliance, Enforcement, and Criminal Investigations
Ocean Food Company Limited 1/26/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD|
- You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c) (1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s two HACCP plans for your various pasteurized fish and fishery products do not list the food safety hazard of “Undeclared Major Food Allergens”. Please refer to Chapter 19 of the 4th Edition of the Hazard Guide for additional information.
- 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, to comply with 21 CFR 123.6 (a) and (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 plans for your various pasteurized fish and fishery products do not list the critical control points of,
- cooling following the pasteurization process for controlling the food safety hazard associated with introduction of pathogens after pasteurization (i.e., post process contamination). Please refer to Chapter 18 of the 4th Edition of the Hazard Guide for additional information.
- label review to control the food safety hazard of Clostridium botulinum in the products that are packaged in oxygen impermeable materials or reduced oxygen packages (i.e., associated with the HACCP plan that identifies the hazard of Clostridium botulinum”). All of your firm’s finished products appear to be labeled to “Keep Frozen” however, in order to ensure control of the hazard of Clostridium botulinum toxin formation, your firm needs to include an additional statement on your labels such as, “Important, keep frozen until used, thaw under refrigeration immediately before use”. In addition, your firm needs to include a critical control point to monitor the presence of these statements on each batch of labels. Please refer to Chapter 13 of the 4th Edition of the Hazard Guide for additional information.
- 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 actions listed in your plans for your various pasteurized fish and fishery products do not include corrective actions that ensure that adulterated products do not enter commerce.
- Your firm is monitoring the (b)(4)” critical control point using End-Point Internal Product Temperature (EPIPT). This approach is suitable when you have conducted a scientific study to validate that the EPIPT that you have selected will provide an appropriate reduction in the number of target pathogens in the slowest heating unit or portion of product under the worst set of heating conditions covered by the study. In addition EPIPT may not be an option when the object is control of Clostridium botulinum type E and non-proteolytic types B and F spores because these spores are extremely heat resistant making this type of measurement impractical. Please see page 319, in Chapter 19 of the 4th Edition of the Hazard Guide for additional information.
- There appears to be a need for a “Thawing” critical control point in your HACCP plans. We note that your Hazard Analysis references a (b)(4) step, but this step is not included as a critical control point in either of your HACCP plans. We suggest that your firm re-evaluate your hazard analysis and the potential need for a (b)(4) (i.e., thawing) critical control point for thawing any of your frozen ingredients used in the manufacturing of your finished fish and fishery products to control the food safety hazard of pathogen growth and potential toxin formation, including Clostridium botulinum toxin formation. Thawing of vacuum packaged or reduced oxygen packaged products, including any raw materials and rework that has been vacuum packaged, will pose a hazard for toxin formation due to the potential for time and temperature abuse.
- There may be a need to identify the food safety hazard of Staphylococcus aureus growth and toxin formation following the broiling and frying steps. Staphylococcus aureus toxin, once formed, is heat stable. Thus any toxin that forms as a result of significant handling, coupled with time and temperature abuse especially following the preliminary broiling or the frying operations, conducted prior to the pasteurization, will not be denatured during the pasteurization process.
and Applied Nutrition