Korean-Owned StarKist Tuna Says 'No' To FDA

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http://www.foodsafetynews.com/2011/03/korean-owned-starkist-tuna-says-no-to-fda/

Korean-Owned StarKist Tuna Says 'No' To FDA

by Dan Flynn | Mar 09, 2011

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

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.

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 suggested

here by the National Resources Defense Council.

http://www.foodsafetynews.com/2011/03/korean-owned-starkist-tuna-says-no-to-fda/