Marler Blog - Providing commentary on food poisoning outbreaks & litigation

As of May 11, at least 15 people in nine states and one person in Canada had been confirmed infected with Salmonella from contact with the contaminated dry dog food or from contact with a pet that had eaten the tainted product, according to the Centers for Disease Control and Prevention (CDC). 

The Form 483 report, posted by the FDA late Tuesday afternoon, was the result of a week-long inspection that began April 12 after an outbreak of human Salmonella Infantis infection was traced to contaminated pet food manufactured at the Diamond Pet Foods plant in Gaston, S.C.

The report states that Diamond was using cardboard and duct tape on some of its equipment and that there were damaged paddles on the conveyor. The inspectors also noted that some surfaces at the facility were encrusted with food residues.

FDA inspectors specifically listed these four observations:

OBSERVATION 1

All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source.

Specifically, no microbiological analysis is conducted or there is no assurance that incoming animal fat will not introduce pathogens into their production and cause contamination of finished product. Also, the firm's current sampling procedure for animal digest does (sic) preclude potential for adulteration after sampling and during storage in warehouse. On 4/13/12, an employee was observed touching in-line fat filter and oil with bare hands.

OBSERVATION 2

Failure to provide hand washing and hand sanitizing facilities at each location in the plant where needed.

Specifically, there are no facilities for hand washing or hand sanitizing in the production areas where there is direct contact with exposed finished feed/food.

OBSERVATION 3

Failure to maintain equipment, containers and utensils used to convey, hold, and store food in a manner that protects against contamination.

Specifically, paddles in conveyor (South or Middle conveyor leading to the screeners going to packaging) were observed to have gouges and cuts, which exhibited feed residues. The damage to the paddles may allow for harborage areas for microorganisms and are difficult to clean and sanitize.

OBSERVATION 4

Failure to maintain equipment so as to facilitate cleaning of the equipment.

Specifically, firm utilizes cardboard, duct tape, and other non cleanable surfaces on equipment. These materials were observed to have residues adhering. The foam gaskets around access doors to the bucket elevators were observed in deteriorating condition and exhibited an accumulation of feed residues and dust.

Diamond Pet Foods recalled nine brands of dry pet foods manufactured at its Gaston plant between Dec. 9, 2011 and April 7, 2012. Several other companies whose food was also produced in the facility have joined the recall. See eFoodAlert for the most up-to-date information on the recall and product distribution.

A total of 258 persons infected with the outbreak strains of Salmonella Bareilly (247 persons) or Salmonella Nchanga (11 persons) have been reported from 24 states and the District of Columbia. 32 ill persons have been hospitalized, and no deaths have been reported. Collaborative investigation efforts of state, local, and federal public health agencies indicate that a frozen raw yellowfin tuna product, known as Nakaochi Scrape, from Moon Marine USA Corporation is the likely source of this outbreak.

FDA 483 Inspection Report (download PDF):

Mr. Dominic Sebastian, Managing Director, Moon Fishery (India) Pvt. Ltd., 11/722/D, Chemical Industrial Estate, Aroor, Alleppy 688534 Kerala India

Observation No. 1

Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.

Specifically, your HACCP plan for raw tuna does not list critical control points at the following process step to control the hazards of Clostridium botulinum, histamine and allergens.

A. There is no Critical Control Point listed on your HACCP plan for the process of cutting, scraping, and vacuum packaging performed in your processing room, kept at a temperature of REDACTED C to control the hazard of pathogen growth and histamine formation.

B. There is no Critical Control Point listed on your HACCP plan for Clostridium botulinum and allergen labeling applied to the primary packaging.

C. There is no Critic al Control Point listed on your HACCP plan for metal detection.

D. In your HACCP plan for receiving tuna, the only critical limit listed is temperature, with no critical limit listed for vessel monitoring and histamine testing records to show that tuna was not temperature abused on the harvesting vessel.

Observation No. 2:

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 REDACTED 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 REDACTED facility is rusty and situated so that the ice cannot 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:

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 was no hand drying devices available in the employee rest rooms on the first floor.

Moon Fishery (India) Pvt. Ltd., the Manufacturer of the Yellow Fin Tuna Nakaochi Scrape that was recently recalled by a U.S. Distributor, is also recalling its 22 pound cases of "Tuna Strips" Product of India AA or AAA GRADE because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. Consumers should take precautions when choosing to eat raw seafood and be sure that the raw tuna they decide to consume is not from the implicated lots. If in doubt, don't eat it.

Moon India became aware of the problem after the FDA sampled tuna strips from a lot not yet in distribution. However as a cautionary measure Moon India agreed to recall tuna strips that were already distributed, none of which is from the suspect lot sampled by FDA. Distribution of these AA or AAA Grade Tuna Strips Product of India is limited to 4 wholesalers: one in Georgia, one in Massachusetts, one in New Jersey and one in New York.

The wholesalers may have broken the shipments into smaller lots for further distribution. The frozen raw yellow fin tuna product was originally packaged in white boxes with black writing naming the importer as Moon Marine USA Corporation, a separate and independent company, and identifying the contents as Tuna Strips AA or AAA, Product of India. The boxes contain several vacuum-wrapped packages with no further labeling.

Distribution of the product has been suspended while FDA and the company continue their investigation as to the scope of the problem.

Product sellers, including distributors and restaurants, should consult their suppliers to determine whether the Tuna Strips from India in their possession originated from Moon India. The product may not be accompanied by lot numbers or labeling information.

CDC collaborated with public health officials in multiple states and the U.S. Food and Drug Administration (FDA) to investigate a multistate outbreak of Salmonella Enteritidis infections which was associated with eating food from a Mexican-style fast food restaurant chain, Restaurant Chain A. Investigative efforts were unable to identify a specific food associated with illness, but data indicate that contamination likely occurred before the product reached Restaurant Chain A locations.

A widely distributed contaminated food product might cause illnesses in a specific region and across the United States. As of January 19, 2012, a total of 68 individuals infected with the outbreak strain of Salmonella Enteritidis have been reported from 10 states. The number of ill persons identified in each state with the outbreak strain was as follows: Texas (43), Oklahoma (16), Kansas (2), Iowa (1), Michigan (1), Missouri (1), Nebraska (1), New Mexico (1), Ohio (1), and Tennessee (1).

Diamond Pet Foods has been linked to at least 14 cases of human Salmonella Infantis infections in nine states, according to a May 3, 2012 report from CDC.  Confirmed outbreak cases have been reported in Alabama (1), Connecticut (1), Michigan (1), Missouri (3), North Carolina (3), New Jersey (1), Ohio (2), Pennsylvania (1), and Virginia (1). Five people were hospitalized.

Recall information from Diamond Pet Foods:

• Chicken Soup for the Pet Lover’s Soul
• Country Value
• Diamond
• Diamond Naturals
• Premium Edge
• Professional
• 4Health
• Taste of the Wild
• Apex
• Kirkland Signature/Kirkland Signature Nature’s Domain
• Canidae

Addition brands recall courtesy of efoodalert:

Natural Balance recalls several products manufactured on its behalf by Diamond Pet Foods, because the products may be contaminated with Salmonella. Please see the Diamond Pet Foods, Etc. Recalls – 2012 page for details on the recalled products.

WellPet LLC recalls Wellness Complete Health® Super5Mix® Large Breed Puppy dry dog food (15-lb and 30-lb bags and 5-oz sample bags; Best by dates of JAN 9 2013 through JAN 11 2013), because the product, which was manufactured by Diamond Pet Foods, may be contaminated with Salmonella.