A sardine cannery in Scotland and a pollock processor in South Korea are the latest foreign seafood companies that could lose the ability to export products to the United States.

Both International Fish Canners (Scotland) Ltd. and Dangjin Food Inc. recently received warning letters from the U.S. Food and Drug Administration (FDA) that say their products could be refused admission to the United States unless they promptly comply with FDA’s requests.

The Feb. 10 warning letter to International Fish, based in the United Kingdom’s town of Fraserburgh, cites “significant violations” of U.S. Seafood Hazard Analysis and Critical Control Point (HACCP) regulations in manufacturing canned sardines.

FDA was in Scotland to inspect the cannery last Oct. 7 and 8, and claims its HACCP plan listed only one critical control point, not the several that would be required to control for scombrotoxin (histamine) formation.

 “Scombrotoxin (histamine) formation is cumulative and all steps in the handling of the sardines, prior to the start of the canning operation, need to be evaluated to determine whether collectively or individually, the exposure times and temperatures occurring during those steps, will result in the need for one or more critical control points,” the warning letter says.

FDA also rapped the Scottish sardine cannery for treating sardines fresh from the harvest vessel as the same as frozen sardines.  “It is expected that the critical control points, monitoring procedures, etc., will be different for these different activities associated with the two forms of the sardines,” the agency added.

FDA asked the cannery to conduct a hazard analysis for fresh and frozen sardines.

“Using one plan for both types of sardines may be acceptable provided that the plan meets the more stringent receiving controls for receiving fresh product, as a primary processor receiving fish directly from the harvest vessels, as well as the more stringent controls for handling the frozen products prior to the start of the canning operation, such as during thawing of the frozen product,” it explained.

FDA also cited several steps in the canning process that it says pose a risk of histamine development, including the holding and factory chill points, and questioned how the company does testing.  The Scottish cannery also does not check for “metal inclusion” that might result from grading, head cutting, and brining before packing in cans.

Dangjin Food Inc., in an April 26 warning letter, was also told its manufacturing procedures include “serious deviations from seafood HACCP” and other U.S. food safety regulations.  It processes boiled, dried anchovies and dried pollock.

FDA said Dangjin’s “HACCP plan for boiled, dried anchovies does not list the food safety hazards of histamine and pathogen growth, including Clostridium botulinum growth and toxin formation.”

“Specifically, your HACCP plan for your boiled, dried anchovies only references metals as a reasonably likely hazard. However, anchovies are a scombroid species susceptible to scombrotoxin (histamine) development as a result of time and temperature abuse,” the warning letter says.  “Your Process Flow Diagram and Hazard Analysis Worksheet list steps that may, as a result of time and temperature abuse, result in excessive histamine development. These may include steps such as thawing and would also include any additional extended storage periods, between thawing and boiling. “

FDA says seafood processors of small fish (less than 5 inches in length) such as anchovies must make sure handling does not contribute to toxin formation.  In addition, it said the HACCP plan for dried pollock must address the food safety hazard of pathogen growth.

The two seafood importers were asked to provide five days worth of monitoring records along with other documentation of compliance with FDA’s requests.

FDA has the power to detain foreign-made food products destined for the U.S. without the need for physical examination upon entry. “This procedure is generally based on past history or other information, such as an inspection of a facility or HACCP plan review, indicating that the factory producing the product or the product itself may not be in compliance with FDA’s laws and regulations,” FDA said.