Inspections, Compliance, Enforcement, and Criminal Investigations
A.P. Bell Fish Company 06-May-03
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
VIA CERTIFIED MAIL
May 6, 2003
Walter T. Bell, President
A.P. Bell Fish Company Inc:
4600 124th Street West
Cortez, Florida 34215
Dear Mr. Bell:
We inspected your firm, at the above address, on December 9-10, 2002, and found that you have serious deviations from the Seafood HACCP regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the fishery products adulterated, within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(4). Accordingly your fishery products are adulterated, in that the ready-to-eat stone crab claws, scombroid (histamine-forming) species, and shrimp products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the Seafood HACCP regulations through links in FDA's home page at www.fda.gov.
The deviations are as follows:
1. 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 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 "Cooked Stone Crab Claws" lists a critical limit, "minimum cooking time [redacted]" that is inadequate.
The critical limit should include the temperature of the cooking process or other critical factors that affect the rate of heating of the product that will eliminate pathogens or reduce their numbers to acceptable levels. Since your cooking process involves boiling the crab claws in water, visual observation of minutes at a rolling boil would be considered adequate for temperature.
2. You must implement the record keeping system listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not maintain the recording log for monitoring the cook time at the "Cooking" critical control point to control pathogen survival listed in your HACCP plan for stone crab claws.
3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with CFR 123.6(c)(3). However, your firm's HACCP plan for "Finfish w/histamines" lists a critical limit of "temp kept below [redacted]F" at the "Receiving" critical control point that is not adequate to control the safety hazard of histamine formation.
If you receive fish directly from the fishing vessels, FDA recommends that, in addition to checking the internal temperature of the fish upon receipt, you either (1) Review and maintain harvest vessel control and sensory examination of a representative sample of fish or (2) Conduct histamine testing and sensory examination of a representative sample fish. Chapter 7 of the FDA Fish and Fisheries Products Hazards and Controls Guidance: Third Edition June 2001 (The Guide) provides detailed recommendations for establishing critical limits FDA considers appropriate. You can find the Guide through FDA's homepage at www.fda.gov.
4. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21.CFR 123.6(c)(4). However, your firm's HACCP plan for scombroid (histamine-forming) species lists a monitoring frequency of "upon entrance to the cooler" at the "Storage" critical control point that is not adequate to control the hazard of histamine formation. For products stored under ice, FDA recommends visual checks for an adequate amount of ice in a representative number of cases at least twice a day.
5. You must adequately monitor sanitation conditions and practices during processing, with sufficient frequency to comply with 21 CFR 123.11(b). However, your firm did not adequately monitor hand washing, hand sanitizing, and toilet facilities; safety of water and ice that contacts food and food contact surfaces; and prevention of cross-contamination with sufficient frequency to ensure control as evidenced by:
Water hose connections used in the processing area lack antisiphonage devices [21 CFR 123.11(b)(1)].
Ice making unit observed with walls rusted and in need of repair. Ice directly below unit was observed to have accumulation of brown film on the ice [21 CFR 123.11(b)(1)].
Hand washing facilities lacked soap and drying towels in the restroom [21 CFR 123.11(b)(4)].
6. Because you chose to include corrective actions in your HACCP Plan for "Finfish w/histamines", your described corrective actions must be appropriate to comply with 21 CFR Part 123.7(b). However, your corrective action of "ice product/store in cooler" does not ensure that adulterated product will not enter into commerce. FDA recommends that the product be rejected or an appropriate sample be taken and analyzed for histamine or the product could be held until it could be evaluated based on time-temperature exposure.
In addition, your firm has established HAACP plans by grouping types of fish processed for a specific food safety hazard. The HACCP regulation 21 CFR 123.6(b)(2) provides for grouping types of fish if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed are identical for all of the fish. Your HACCP plans should specify which specific fish apply to each group. We also suggest you review and revise your HACCP plans, after conducting hazard analyses, to ensure HACCP plans are established for each appropriate group of fish.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating. In addition, we may not provide certificates to. your firm for export of your products to European Union(EU) countries if you do not correct these deviations.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the, specific things you are doing to correct these deviations. You may wish to include in your response documentation such as revised HACCP plans and completed monitoring records or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations, and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Shari J. Hromyak, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, please contact Ms. Hromyak at (407) 475-4730.
Emma R. Singleton
Director, Florida District