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Hilo Fish Company Recall After Hepatitis A Found in Frozen Tuna

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), are assisting state and local officials in assessing the risk of hepatitis A virus exposure from contaminated frozen tuna sourced from Sustainable Seafood Company, Vietnam, and Santa Cruz Seafood Inc., Philippines. If unvaccinated consumers have consumed the recalled product within the last two weeks, post-exposure prophylaxis may help prevent hepatitis A virus infection.

Fast Facts

  • On May 18, Hilo Fish Company began recalling tuna sourced from Sustainable Seafood Company and Santa Cruz Seafood, Inc. that tested positive for the hepatitis A virus.
  • While the CDC is not currently aware of any illnesses linked to these products, it is advising post exposure prophylaxis (PEP) for unvaccinated persons who may have consumed the potentially contaminated tuna within the past two weeks.
  • The FDA is providing a list of establishments in TX, OK, and CA that may currently have potentially contaminated tuna in commerce to help alert consumers that may be at risk of the hepatitis A virus. Contact your health care professional if you believe you have been exposed to contaminated tuna.
  • The current recall resulted from follow-up after the Hawaii Department of Health notified the FDA of a frozen tuna sample, sourced from PT Deho Canning Co.,which tested positive for hepatitis A on May 1, 2017. The initially recalled product has been removed from circulation and the newly recalled frozen tuna lots were not shipped to Hawaii, but were shipped to the mainland U.S.

What was the Problem and What was Done About It?

Consumers may be at risk of contracting a hepatitis A infection due to the consumption of potentially contaminated frozen tuna distributed by Hilo Fish Company and sourced from Sustainable Seafood Company (Lots F5-6 Soui Dau Industrial Zone, Can Lam Khanh Hoa Province, Vietnam) and Santa Cruz Seafood, Inc. (General Santos Fishport Complex Tambler, General Santos City, 9500, Philippines). The CDC reports no illnesses to date.

The FDA is collecting additional frozen tuna samples and increasing its screening measures and testing for imported seafood for these companies.

In addition, the agency has prepared a list of restaurants and other retail locations that received the recalled frozen tuna. The agency will continue to update this list as its investigation continues. To protect the health of consumers who may have eaten contaminated tuna and require post-exposure prophylaxis, the FDA has determined that it is necessary to make public the names of these businesses as part of the recall.

Background

On May 1, the Hawaii Department of Health notified the FDA that a sample of frozen tuna cubes from Indonesia tested positive for the hepatitis A virus. On May 2, the FDA contacted the Tropic Fish Hawaii LLC, a subsidiary distributor of Hilo Fish Company, to obtain additional information related to the positive tuna sample. Tropic Fish Hawaii LLC initiated a product recall because the affected product had been distributed to its customers in Oahu, Hawaii (U.S. mainland and other Hawaiian Islands were not affected by the recall). The state of Hawaii embargoed the lot that tested positive and the FDA confirmed the sample was positive.

On May 16, Hilo Fish Company notified the FDA that it had submitted samples of additional shipments held in its cold storage facility in Hawaii to a private laboratory for testing and received additional positive results for the hepatitis A virus. Imported tuna products from this facility were sourced from Sustainable Seafood Company and Santa Cruz Seafood and were distributed to restaurants and other retail locations in CA, NY, OK, and TX. The New York State Department of Health and the FDA verified that product shipped to New York was not sold to the public. The FDA’s investigation in connection with these firms is ongoing.

MORE:

FDA Warns Hawaii Seafood Processor About Handling of Tuna

A seafood-processing facility in Honolulu was found to have “serious violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations during a May 17 and 20 inspection by the U.S. Food and Drug Administration.

Click to read the warning letter

Click to read the warning letter

The resulting warning letter, dated July 27 and sent from the agency’s San Francisco District Office, informed Tropic Fish Hawaii LLC that its “fresh, refrigerated histamine-forming fish products, including Ahi tuna, mahi mahi, and skipjack tuna” are therefore adulterated, meaning that “they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”

FDA acknowledged the company’s June 13 response to the inspection results, but found that it did not adequately address all the problems observed by inspectors.

The warning letter states that Tropic Fish Hawaii LLC “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 federal law.

FDA noted that the company’s HACCP plan for fresh, refrigerated histamine-forming fish, including tuna, does not list the critical control point of refrigerated storage for controlling the food safety hazard of scombrotoxin (histamine) formation.

An agency investigator observed refrigerated product storage to be at 44 degrees F and the internal temperature of two Ahi tuna in the room to be at 42 degrees F. However, FDA’s letter stated that refrigerated, not frozen, storage or processing of raw product is to be held at a cooler temperature of 40 degrees F or below.

Or, if the fish are stored under ice, the product must be completely and continuously surrounded by ice throughout the storage time, according to the warning letter.

FDA also pointed out that the firm’s HACCP plan for fresh, refrigerated histamine-forming fish such as tuna does not list the food safety hazard of pathogenic bacteria growth for fish intended for raw consumption. The company responded that pathogenic bacteria growth was not considered a potential hazard because it uses potable water in the facility.

“Your response is not adequate and your hazards analysis is incorrect,” the warning letter states. “FDA has identified pathogenic bacteria growth and toxin formation as a food safety hazard in finfish, i.e. tuna, intended for raw consumption and control of this significant hazard must be included in your HACCP plan in the event of time and temperature abuse.”

FDA’s letter also mentioned that the firm was observed monitoring the surface temperature of fish at receiving with an infrared thermometer.

“Your response received on June 13 stated that you have now resumed taking the internal temperature of the fish with a probe thermometer. We will verify the adequacy of your corrective action during our next scheduled inspection,” the letter stated.

Other problems cited at the facility involved current good manufacturing practice requirements. These included not monitoring for the prevention of cross-contamination, insufficient cleaning of food contact surfaces, and inadequate control of employee health conditions.

Specifically, the letter states that an investigator observed unprocessed Ahi tuna intended for raw consumption being stored on a concrete floor and then dragged across the floor onto a pallet by an employee.

The company responded that the employee had received a written warning and was counseled, extra pallets were added for storage, and that plastic platform trucks were ordered to help move products.

FDA called that response “not completely adequate because you have not addressed the steps you have taken to ensure prevention of other employees from engaging in the same practice.”

Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring.