After crossing 3,400 miles of the Pacific Ocean last year to inspect a tuna cannery on American Samoa, a U.S. Food and Drug Administration (FDA) inspector asked for copies of some records from the StarKist Co.
“Charlie the Tuna,” the company’s half-century old cartoon character, might have shown the man some “good taste,” but nobody from StarKist Co. would show the FDA employee the records.
StarKist, once a unit of San Francisco-based Del Monte Foods, is now owned by South Korea’s Dongwon Industries. The title papers for Pittsburgh-based StarKist went to Dongwon two years ago for $363 million. Dongwon F&B was already the world’s largest canned tuna business, but it wanted StarKist as a vehicle to make inroads into the U.S. market.
For America Samoa, an unincorporated territory of the United States, the new owners of StarKist have been bad news. StarKist employment on the South Pacific Island has been cut in half since the takeover. There is also a nasty dispute going between StarKist and Samoa’s power company over some property.
At the cannery inspection last Nov. 1-4, FDA found “serious violations” involving StarKist’s seafood Hazard Analysis and Critical Control Point plan and its production of low-acid canned foods. FDA said both the canned tuna and pouched packed tuna being produced by StarKist on American Samoa are “adulterated.”
Asked by Food Safety News about the warning letter, StarKist spokeswoman Mary Sestric said: “All StarKist products are safe and no product withdrawals are being initiated.”
“The quality and safety of all StarKist products continues to be our highest priority. We are committed to providing high-quality, nutritious products to consumers and look for ways to continually improve our products and processes. StarKist continues to work closely with the FDA to that end,” she added.
During the November 2010 inspection, FDA personnel wanted to copy certain StarKist records, but the company declined.
FDA says that upon written demand during the course of an inspection, “the commercial processor shall permit the inspection and copying by such employee, all records of processing, deviations in processing, container closure inspections, and other records specified in part 113, to verify the adequacy of processing, the integrity of container closures, and the coding of the products.”
It sought without success, FDA said, to inspect and copy records covering the production of StarKist tuna in 3 oz. and 43 oz. pouches produced at the American Samoa processing plant between Aug. 1 and Nov. 1, 2010.
John A. Maxfield, director of quality assurance at StarKist Co. in Pittsburgh, wrote FDA after the inspection to argue that summary reports do not have to be produced by the company and are not part of the food safety program.
FDA said it wanted the records to determine StarKist’s actual percentage of defects under manufacturing conditions on certain of its lines.
“The information from these records is necessary to determine the capability of your filling and sealing equipment to consistently produce pouches of finished tuna fish with hermetic seals,” the warning letter says. Investigators were reacting to the number of pouch defects they found during the November 2010 inspection.
FDA said that if StarKist does not promptly correct the violations, it will take further actions, including seizing adulterated products and/or enjoining the company from operating. It could also refuse admission (to the U.S. mainland) of its tuna under “detention without physical examination.”
Under multiple HACCP violations, the FDA inspectors said they found several racks of thawed, pre-cooked loins still in their plastic vacuum packages staged in the processing room and stacked on production tables for further processing in air temperatures of 76 to 81 degrees.
The food safety hazard of Staphylococcus aureus can occur in temperatures of 70 degrees or more after three hours.
In comments about low acid canned foods, FDA says where double seams or glass containers are not used, detailed inspections and test intervals are required to ensure proper closure and hermetic seal production.
StarKist does not perform a meaningful destructive test on heat sealed pouches of tuna products at intervals of sufficient frequency under manufacturing conditions, FDA said.
Maxfield’s letter said StarKist uses both burst testing and tensile strength testing. He said the company was following an industry standard for visual double seam checks, but would take FDA’s advice into account.
FDA said destructive tensile strength testing is not appropriate because the pouches being tested are not first filled with tuna fish. Instead they are tested empty.
On the day FDA was sending its warning letter, Dongwon installed a new president at StarKist. In-Soo Cho, a graduate of the University of Chicago Booth School of Business with a management history with Proctor and Gamble and Yum Restaurants International, took over.
The 65-year old StarKist brand has two processing facilities in Ecuador in addition to the one just inspected in American Samoa.
Mercury content of canned tuna frequently comes up as a food safety issue. The problem is that mercury can accumulate in the body. Both FDA and the Environmental Protection Agency (EPA) say women of child-bearing age, and young children should avoid fish that are high in mercury.
Others may want to pace their tuna consumption along the lines suggestedhere by the National Resources Defense Council.