A New York seafood importer and a Wisconsin food manufacturing facility were on the receiving end of recently posted U.S. Food and Drug Administration (FDA) warning letters. On Nov. 3, FDA sent a warning letter to Vern’s Cheese Inc. in Chilton, WI, stemming from inspections on May 20 and 27, and June 2, 2015. The letter stated that Vern’s had “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, resulting in the company’s ready-to-eat seafood products being adulterated. Vern’s responded to the FDA inspection, but the agency said HACCP deviations remain, specifically:

  • Scombrotoxin (histamine) formation – FDA stated that Vern’s receives and stores products such as Herring in Wine and Creamed Fillet of Herring in plastic containers. “Herring is a scombroid species capable of developing elevated levels of scrombrotoxin (histamine) when exposed to time and FDA Warningtemperature abuse. Therefore, your HACCP plan needs to identify the food safety hazard of scombrotoxin (histamine) formation and include adequate controls at receipt and storage to ensure proper refrigeration temperatures are maintained,” FDA noted in the warning letter.
  • Clostridium botulinum growth and toxin formation – “The plastic containers holding the Herring products allow for a reduced oxygen environment conducive to Clostridium botulinum growth and toxin formation as a result of time and temperature abuse. The HACCP plan fails to identify and control for the C. botulinum hazard present in these products,” FDA stated.

The agency told Vern’s that it must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). “However, your firm’s HACCP plan for your ready-to-eat fish products lists monitoring procedures/frequencies at the Receiving and the Temperature During Storage critical control points that are not adequate to control the hazard of pathogenic bacteria growth,” the agency added. At the “Temperature During Storage” critical control point, Vern’s monitoring procedure indicates that it has an alarm system that notifies the warehouse operator when temperatures in the cold storage exceed the critical limit of (b)(4)°F for more than (b)(4) minutes, with a “visual check” once “per time period.” “This monitoring procedure is not adequate because it allows for opportunities for unsafe time and temperature exposures to occur,” the warning letter continues. “For example, your current procedure allows for multiple occurrences of temperatures exceeding your critical limit that could accumulate over the storage period. Further, on the days that your Walk-in Cooler log shows a visual check, it consists of a single reading on the digital thermometer, which does not ensure the critical limit was consistently met during the duration of refrigerated storage.” FDA recommended that Vern’s maintain a record of the temperatures during storage, for example, by acquiring a report or printout from the alarm company, or confirming with the alarm company that the cooler was within the critical limit and/or the duration of any out-of-limit conditions. Another FDA warning letter was sent on Nov. 10 to Evelyn Effan, a sole proprietor exporter based in Bronx, NY. Her “significant violation” was failure to implement an affirmative step which ensures that the imported fish and fishery product(s) are processed in accordance with the seafood HACCP regulations. The concern was specifically about smoked fish herring and smoked akwabi, FDA stated, since a sample of each was collected and, after laboratory analysis, the agency found that all the fishery products were uneviscerated. “We may take further action if you do not promptly correct these violations,” the letter noted. “For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on ‘detention without physical examination,’ seize your product(s) and/or enjoin your firm from further violating the Act,” FDA stated. The agency asked both businesses for a response to the issues raised within 15 working days from the receipt of the letters. (To sign up for a free subscription to Food Safety News, click here.)