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The contaminated raw tuna that is responsible – as of May 2, 2012 – for at least 258 Salmonella illnesses in 24 states and the District of Columbia was produced under filthy conditions in a substandard food manufacturing plant in Kerala, India.

FDA inspected the Kerala facility where Moon Fishery (India) Pvt. Ltd. produced the contaminated “Tuna Scrape” that was exported to the USA and sold to restaurants and grocery stores through distributors in Illinois, New Jersey, New York Massachusetts, Georgia, North Carolina, Texas and Maryland. The inspection took several days (April 19th – 24th, 2012).

Earlier today, Marler Blog released the initial Inspectional Observations Report (known as the 483) from that FDA inspection. It doesn’t take an advanced degree in microbiology or a great deal of imagination to deduce the probable source of the Salmonella contamination after reading the following observation, reproduced in full from the report:

You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, maintenance of hand washing, hand sanitizing, and toilet facilities, and protection of food, food packaging material, and food contact surfaces from adulteration.

A- You are not monitoring the safety of water as evidenced by:

1- Tanks used for storage of process waters have apparent visible debris, filth, and microbiological contamination. Sand and activated carbon filter units used in manufacturing of water are not sanitized, and ventilation for tanks is not filtered to protect against contamination. There is no laboratory analysis for water used in ice manufacturing at the … facility to show the water used to make ice is potable. Ice manufacturing lacks sanitary controls: ice manufacturing equipment at the Moon Fishery facility is located outside and is susceptible to adulteration from pests and the environment. Apparent bird feces were observed on the ice manufacturing equipment at Moon Fishery; insects and filth were observed in and on the equipment. Ice manufacturing equipment at your … facility is rusty and situated so that the ice can not be protected against adulteration, as the ice manufacturing process is constructed into the flooring of the ice facility. Tuna processed at your facility, which is consumed raw or cooked, comes in direct contact with water and ice.

B- You are not monitoring the condition or cleanliness of food contact surfaces as evidenced by:

1-Some of the floor and wall tiles in the tuna processing area are broken and cracked, not allowing for proper cleaning.

2- After cleaning, the ceiling directly above the in-process tuna line was observed to have visible product residue.

3-After cleaning, product residues and rust were observed on knives and utensil storage boxes. These knives are used to cut raw tuna.

C-You are not monitoring protection from adulterants as evidenced by:

1-Peeling paint was observed directly above the in-process tuna line.

D-You are not monitoring hand washing, hand sanitizing and toilet facilities as evidenced by:

1-There were no hand drying devices available in the employee rest rooms on the first floor.

In short, the place was a mess!

There has been a tremendous amount of focus over the years on China as a source of hazardous foods and food ingredients. There has been very little media attention paid to India, even though that densely populated country struggles with a chronic shortage of sewage treatment facilities, a limited supply of potable water, and frequent food poisoning outbreaks.

Last month (April 2012), FDA refused 223 shipments of foodstuffs and other products from China, and 222 shipments from India. Reasons for rejecting food products from India included Salmonella, pesticides and process adulteration.

FDA physically examines less than 2% of all imported food shipments under its jurisdiction. The agency can’t be expected to check every shipment – it hasn’t the money, the staff or the lab facilities to do so.

It’s time to put the burden of demonstrating the safety of imported foodstuffs onto the shoulders of the producers and importers.

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