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.

The multistate outbreak of Salmonella Bareilly illness now stands, officially, at 93 people infected in 19 states and the District of Columbia, according to an Investigation Announcement released by CDC.

Illnesses have been confirmed in Alabama (2), Arkansas (1), Connecticut (4), District of Columbia (2), Georgia (4), Illinois (8), Louisiana (2), Maryland (8), Massachusetts (4), Mississippi (1), Missouri (1), New Jersey (6), New York (23), North Carolina (2), Pennsylvania (2), Rhode Island (4), South Carolina (3), Texas (3), Virginia (5), and Wisconsin (8). Ten outbreak victims have been hospitalized. Seventeen of the 23 New York cases were reported from outside of the New York City area.

The number of confirmed cases will grow. eFoodAlert already has been told by the Connecticut Department of Public Health that they have identified five victims (compared with the total of four victims reported by CDC in that state).  None of the Connecticut outbreak victims were hospitalized. Investigations and food trace back activities are still underway in a number of states, including California, which is not one of the 19 states to have reported cases.

Illness onset dates range from January 28 to March 23, 2012. The youngest confirmed patient is 4 years old; the oldest is 78. Among the people for whom a food history is available, 69% reported eating sushi, sashimi or similar foods in the week before illness onset. This compares with a survey of healthy people in which only 5% reported having consumed these types of food.

Details are still sketchy, but a few states have shared additional information with eFoodAlert or have posted a summary on its website. Here is what we know, as of today (April 5th):

• Connecticut:- Five outbreak cases identified; none hospitalized. Victims became ill in mid-February and early March.
• Illinois:- The Illinois Department of Public Health reports nine confirmed cases, including three who were hospitalized. Illness onset dates range from February 11th to March 17th. Outbreak cases were reported from Chicago (6), Cook County (1) and Will County (2).
• Louisiana:- Two confirmed cases (one male and one female); both hospitalized. Both became ill in mid-February. One of the victims reported eating spicy roll sushi in the week before becoming ill. No food history is available for the other victim.
• New York State:- Seventeen confirmed cases (excluding New York City, which is covered by its own health department); one person hospitalized. The earliest New York State victim became ill on March 1st. Victims range from 16 to 78 years of age.
• Virginia:- Five confirmed cases; none hospitalized. The earliest illness onset date was early February. All five outbreak victims are 20-50 years old, and live in the central and northwestern part of the state.
• Wisconsin:- The Wisconsin Department of Health Services reports eight confirmed cases – three in Milwaukee and five in Waukesha. All are adults. Three of the eight were hospitalized.

The following states have informed eFoodAlert that they have not identified any outbreak related cases, and have no suspect cases under investigation at this time: Alaska, Arizona, Hawaii, Idaho, Iowa, Maine, Minnesota, Nebraska, Nevada, New Hampshire, Oklahoma, Utah, and Wyoming.

CDC reports that the investigation has not yet conclusively identified a food source. Federal, state and local health officials are continuing to identify and interview other outbreak victims.

At this stage in the investigation, CDC has no specific advice or recommendations for the public, and is not suggesting that consumers avoid eating any particular foods.

The multistate outbreak of Salmonella Bareilly illness that was first reported yesterday now stands at 93 people infected in 19 states and the District of Columbia, according to an Investigation Announcement just released by CDC.

Illnesses have been confirmed in Alabama (2), Arkansas (1), Connecticut (4), District of Columbia (2), Georgia (4), Illinois (8), Louisiana (2), Maryland (8), Massachusetts (4), Mississippi (1), Missouri (1), New Jersey (6), New York (23), North Carolina (2), Pennsylvania (2), Rhode Island (4), South Carolina (3), Texas (3), Virginia (5), and Wisconsin (8). Ten outbreak victims have been hospitalized. Seventeen of the 23 New York cases were reported from outside of the New York City area.

The number of confirmed cases will grow. eFoodAlert already has been told by the Connecticut Department of Public Health that they have identified five victims (compared with the total of four victims reported by CDC in that state).  None of the Connecticut outbreak victims were hospitalized. Investigations and food trace back activities are still underway in a number of states, including California, which is not one of the 19 states to have reported cases.

Illness onset dates range from January 28 to March 23, 2012. The youngest confirmed patient is 4 years old; the oldest is 78. Among the people for whom a food history is available, 69% reported eating sushi, sashimi or similar foods in the week before illness onset. This compares with a survey of healthy people in which only 5% reported having consumed these types of food.

CDC reports that the investigation has not yet conclusively identified a food source. Federal, state and local health officials are continuing to identify and interview other outbreak victims.

At this stage in the investigation, CDC has no specific advice or recommendations for the public, and is not suggesting that consumers avoid eating any particular foods.