A seafood processing facility in New York is on notice from the Food and Drug Administration for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
Officials from the FDA inspected the Bronx, NY, the location of Fair Fish Co., Inc. on Feb. 27 and 28, and March 8, 2018. According to a May 31 warning letter recently made public by the FDA, the facility’s ready-to-eat pasteurized canned crabmeat may be injurious to health because it was prepared, packed or held under unsanitary conditions.
The report cited several significant violations in relation to the seafood HACCP regulation for fish or fishery products:
- The firm failed to take a corrective action to control the food safety hazard of C. botulinum toxin formation when their process for pasteurized canned crabmeat deviated from their HACCP plan’s critical limit at the receiving critical control point (CCP);
- Review of the firm’s pasteurized canned crabmeat receiving monitoring records for the date of December 4, 2017 revealed that the firm deviated from their critical limit without taking a corrective action that ensured the safety of the product was evaluated, affected product did not enter interstate commerce, and that the firm had regained control over the operation.
- Specifically, “In addition, the product was not covered with ice or other chemical cooling media. Your firm received the shipment of pasteurized crabmeat without conducting a time/temperature assessment and without conducting a corrective action. The product was later distributed into commerce.”
- The FDA noted a March 23 response letter including a revised HACCP Plan for their pasteurized canned crabmeat, however, “your response is inadequate because your firm has not conducted a time/temperature assessment of the affected lots of pasteurized canned crabmeat received on December 4, 2017, that exceeded your critical limit,” and, “your response does not indicate an assessment will be conducted of other lots of product,” finally, “your response does not include actions your firm will take to prevent recurrence.”
- The firm’s HACCP plan for pasteurized canned crabmeat lists a critical limit of temperature at the receiving and refrigerated storage CCPs that is not adequate to control C. botulinum toxin formation;
- The FDA recommends that strict refrigeration control (i.e., at or below 40°F (4.4°C)) should be maintained during storage and distribution to prevent growth and toxin formation by C. botulinum type A and proteolytic types B and F.
- The FDA also recommends a maximum cumulative exposure time of 2 hours at a product temperature of above 70°F in order to control germination, growth, and toxin formation by C. botulinum type A and proteolytic types B and F.
- “Your revised HACCP plan’s critical limit allows for the product temperature to be above 70°F for up to (x) during transit and up to an additional (y) during refrigerated storage without requiring a corrective action to be taken. This exceeds a cumulative exposure time of 2 hours at a temperature of above 70°F and is not adequate to control C. botulinum toxin formation.”
- In the firm’s response letter, the FDA noted that the revised HACCP plan lists a critical limit at the receiving and at the refrigerated storage CCPs that is not adequate to control the significant hazard of C. botulinum.
- “Your revised pasteurized canned crabmeat HACCP plan dated March 19, 2018, does not include notification of rejection or returning the product to the sender;”
- “Further it is not only important to notify the supplier of the deviation but also to discontinue the use of the supplier until evidence is obtained that transportation and handling practices have been improved,”
- “Your revised pasteurized canned crabmeat HACCP plan does not ensure the cause of the deviation is corrected at the receiving CCP and refrigerated storage CCP;” and
- The firm stated that additional employees will be trained and HACCP certified in order to perform monitoring and corrective action activities, however, their response is inadequate; “Your response does not include supporting evidence that additional employees have received seafood HACCP training or the interim action you plan to implement.”
“Under FDA regulations, all facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are responsible for ensuring that their overall operation and the products they distribute are in compliance with the law.
The FDA’s 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance, the Hazards Guide, “provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products.”
The Hazards Guide states that, “This guidance is intended to assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find information in this guidance that will help them identify hazards that are associated with their products, and help them formulate control strategies. The guidance will help consumers and the public generally to understand commercial seafood safety in terms of hazards and their controls.”
The FDA allows companies 15 working days to respond to warning letters. If companies fail to properly correct violations, legal action can result in seizure of products and injunctions stopping operations. FDA has not yet posted a closeout letter on the case.
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