‘Millions’ of roaches plagued maker of Pedigree, IAMS, Cesar, other pet foods

This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission

The Mars Petcare U.S. Inc. low-acid canned pet food production facility in Columbus, OH, was crawling with an infestation of German cockroaches between October 2016 and July 2017. Mars markets wet dog and cat foods in cans, plastic tubs, and laminated pouches under the Pedigree, Cesar, Whiskas, Nutro and IAMS brands.

Pet food from the plant also generated consumer complaints about finding hard plastic pieces and a complaint about a elastic material in Mars’ pet foods.

On Oct. 7, 2016, Mars initiated a recall of 54,255 cases of CESAR Classics Filet Mignon Flavor canned dog food after the complaints about plastic. The recalled products were shipped to 36 states, including to three government facilities.

Ensuing inspections found the company had not completed repairs as promised.

Documents obtained by Food Safety News show that, during a July 2017 inspection of the Columbus facility, investigators from the Food and Drug Administration observed two significant deviations from current Good Manufacturing Practices (cGMP):

Failure to inspect, segregate, or otherwise handle raw materials and ingredients used in manufacturing under conditions that will protect the animal food against contamination and minimize deterioration; and
Failure to take effective measures to exclude pests from [the] plant and protect against contamination of animal food by pests.

Roaches and other pests
The infestation was first documented during an Oct. 27, 2016, comprehensive low-acid canned food (LACF) inspection by FDA, according to documents obtained under the Freedom of Information Act.

Although Mars management undertook to address and remedy the infestation in October 2016, FDA investigators observed a live roach in the manufacturing area adjacent to an area where in-process raw materials and ingredients are maintained, and another near the main hand-wash station at the entrance to the manufacturing area during the July 2017 inspection.

According to the company’s Employee Pest Sighting Log, there were 99 instances of pest activity observed during a 72-day period from Nov. 10, 2016, to July 14, 2017, including one instance described as “millions of roaches.”

Employees also reported birds, spider webs, beetles, multiple flies, maggots and larvae on several occasions.

Mars contracts with a pest control operator (PCO) for routine rodent and insect control.

During their review of the PCO’s reports, FDA investigators found references to photographic evidence of pest activity, disrepair of dock doors, general disrepair of the building — including areas of ingress and egress — excessive spills of raw materials and damaged cans “covered” in flies. The photographs had not been retained by the company.

Several of the PCO observations regarding necessary repairs were repeated in multiple consecutive reports. For example, damage to a dock door was first reported on or about Sept. 26, 2016. The report was repeated after each visit until the door was finally repaired on or about Nov. 3, 2016.

Foreign objects – pieces of plastic
In addition to ongoing pest problems, Mars logged repeated violations related to the pieces of hard plastic that spurred the Oct. 7, 2016, recall.

During a March 31, 2017, recall follow-up inspection, Mars informed FDA that the firm had fully implemented corrective actions/preventative actions (CAPAs), including changing all food-contact white plastic material to a blue plastic material, enabling the presence of white plastic foreign objects to be detected more easily.

Despite this assurance, FDA inspectors were told on July 11, 2017, that only the “majority” of the belts and plastic wear plates on critical equipment had been changed out by that date.

As of the July 2017 inspection, Mars acknowledged that it was still receiving complaints from customers about foreign objects in its finished products.

FDA has received two new consumer complaints for plastic foreign objects in Mars canned, tubbed or pouched products since the inspection, according to an agency spokesperson. One of these was for an elastic-type object and the other was for two small, hard plastic pieces. The consumer did not provide a product lot number in the second case, and it is unclear whether the two complaints concerned product manufactured in the Columbus facility.

Refusals and obstruction
The Establishment Inspection Report (EIR) documents a lack of cooperation on the part of Mars management during the July 2017 inspection.

FDA investigators reported Mars officials refusing to cooperate on three points three during the course of the inspection, including:

Refusal to permit photography
Refusal to permit the review of consumer complaints
Refusal to provide photocopies of consumer complaints, manufacturing, shipping and pest control records.

In addition to the outright refusals reported in the EIR, investigators encountered delays in the production of requested documents and information, and denial of complete access to all areas of the facility.

When faced with a refusal, FDA investigators are expected to call attention to the relevant section of the Food, Drug and Cosmetic Act or the Public Health Service Act, and then to complete the inspection, according to Chapter 5 of the FDA Investigations Operations Manual (2018).

The company’s lack of cooperation resulted in a delay in the completion of the inspection, which was begun on July 11, 2017, but was not completed for more than two weeks, on July 26.

According to an FDA spokesperson, the Office of Regulatory Affairs issued an Untitled Letter to Mars subsequent to the July 2017 inspection. An Untitled Letter is used “…for violations that may not meet the threshold of regulatory significance for a warning letter and request correction of the violations.”

The investigation triggered by the recall is now closed.

Raw milk, farm animals likely cause of new E. coli outbreak among children

This story by Coral Beach first appeared in Food Safety News and is reposted here with permission.

Unpasteurized, raw milk and a visit to an unrelated agricultural animal operation are most likely the causes of an outbreak of E. coli infections among children in Knox County, TN. At least four of the victims are in kidney failure.

Health department spokeswoman Katharine Killen told Food Safety News this afternoon that all of the confirmed illnesses have been caused by the same serotype of E. coli bacteria. During a press conference with local media today, Dr. Joe Childs of East Tennessee Children’s Hospital also reported that all of the cases at that hospital are from one serotype.

Knox County Health Department epidemiologists are working with investigators from the state’s health department and other local and state agencies, including agriculture officials to pinpoint the source of the bacteria.

Childs said the ongoing E. coli outbreak is the largest he has seen in his 30 years at the hospital. Killen said the county averages only about 19 cases on an annual basis. Both said some of the sick children had consumed unpasteurized milk in the days before their symptoms began.

Other victims visited a farm unrelated to the raw milk dairy before becoming ill. Cows and other animals carry E. coli that can cause serious infections in humans. Swimming pools, however — especially public pools — are not a likely source because chemicals used to treat the water are very effective at killing E. coli bacteria, Childs said.

Officials have not specified what kind of agricultural animals victims of the current E. coli outbreak came into contact with before becoming ill. Goats are among the animals that can carry E. coli. Photo illustration

Neither the doctor nor the county spokeswoman would identify the dairy or animal farm. Killen said she wasn’t sure if the dairy was still selling its unpasteurized milk as of this afternoon. A conference call set today could provide more details.

The county started receiving reports about a cluster of E. coli infections among children last week, Killen said. She did not provide the total number of cases or the age range of the patients. However, there are “several” cases and all are children, according to county information.

The East Tennessee Children’s Hospital started hearing about the cluster of E. coli illnesses about 10 days ago, Childs said. He said the hospital is “approaching” 10 cases. Some children who were admitted have recovered enough to go home. Other’s are more seriously ill. Children started being admitted to intensive care units at the hospital about four days ago. Four of the children have developed a life-threatening form of kidney failure called hemolytic uremic syndrome (HUS).

Tennessee is one of the states that allows sales of unpasteurized raw milk. Federal law prohibits the interstate sale of raw milk because of its high risk for causing foodborne illnesses. Young children, elderly people, pregnant women and people with depleted immune systems are at the highest risk of developing life-threatening complications, according to a wide variety of health care providers and other entities.

Among those recommending against consumption of unpasteurized, raw milk are the American Academy of Pediatrics, state health departments, the federal Centers for Disease Control and Prevention, the Food and Drug Administration, and the U.S. Department of Agriculture.

Pasteurization is the process of heating milk to 161 degrees F for 15 seconds. It kills bacteria, viruses and parasites commonly carried by dairy cows. Those pathogens include E. coli, Listeria monocytogenes and Brucella.

Photo illustration

Advice to consumers
Anyone in the Knox County area — including people who consumed raw milk from the area or visited an animal operation — who develops symptoms of E. coli infection should immediately seek medical attention.

People should make sure their doctors know about their possible exposure to the pathogen so the proper diagnostic testing and treatment can be provided, Childs said.

Antibiotics generally should not be used for E. coli infections because the bacteria die off and release even more toxins into the body. This complicates diagnosis because the symptoms of E. coli infections are similar to other illnesses that should be treated with antibiotics.

Symptoms usually begin one to eight days after ingesting the bacteria, according to the U.S. Centers for Disease and Prevention. Symptoms can include diarrhea that can range from mild and watery to severe and bloody; abdominal cramping, pain or tenderness; nausea; and vomiting in some people.

Healthy adults usually recover from E. coli O157:H7 infections within a week. Young children, older adults, pregnant women and people with compromised immune systems have a greater risk of developing a life-threatening form of kidney failure called hemolytic uremic syndrome (HUS).

Consumers’ cases against Gravy Train maker consolidated

This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission

A class action lawsuit was filed May 1 in Northern California against Big Heart Pet Brands Inc. on behalf of consumers and businesses who bought pentobarbital-contaminated dog food manufactured by the company.

Big Heart is owned by the J.M. Smucker Co.

The lawsuit, referred to as a master consolidated complaint, consolidates four similar actions filed in February and March against the company.

The complaint accuses Big Heart of several counts, including negligent misrepresentation, violation of California’s Consumers Legal Remedies Act, false advertising, negligence, breach of express warranty, breach of implied warranty, fraud and deceptive and unfair trade practices.

Plaintiffs are seeking an order preventing Big Heart from selling the contaminated dog food, a mandatory corrective advertising campaign, full restitution and an unspecified amount of actual, statutory and punitive damages.

The pentobarbital problem came to light in February, when a Washington, D.C.-television station’s investigation into potential pentobarbital contamination in canned, wet dog food revealed the presence of the drug in several Gravy Train products. Veterinarians use large doses of the fast-acting drug to euthanize animals.

Gravy Train is manufactured by Big Heart.

Mark Johnson, one of the plaintiffs named in the class action suit, owned 13 border collie and Australian shepherd mixes, which he used as herding dogs for his cattle. All of Johnson’s dogs developed kidney failure within a few hours after eating a Gravy Train product and had to be put down on Jan. 14 and 15, according to the complaint.

There is no mention in the complaint of a confirmed cause of the kidney failure, or of any laboratory analyses being carried out either at necropsies on the dogs or on the dog food.

The presence of pentobarbital at any level in animal food renders the product adulterated, according to the US Food and Drug Administration (FDA).

Oral exposure to pentobarbital causes primarily neurological symptoms including drowsiness, dizziness, excitement, loss of balance, jerky eye movements, and, in the most severe cases, coma and death. Kidney failure is not one of the reported manifestations of oral pentobarbital poisoning.

An investigator from the FDA’s Philadelphia district office visited Big Heart’s Bloomsbury manufacturing facility five times between Feb. 23 and March 12, 2018, according to information obtained by Food Safety News in response to a Freedom of Information Act (FOIA) request.

At the end of the inspection, the investigator cited the presence of pentobarbital in a retained sample of tallow from February 2017 and in a sample from the company’s current inventory of tallow. The tallow is among ingredients used in the manufacture of Gravy Train, Kibbles ‘n Bits, Skippy and Ol’ Roy canned, wet dog food brands.

On Feb. 16, FDA alerted consumers to the potential contamination issue and advised the public that Smucker was withdrawing from the market a wide range of canned, wet dog food products.

The withdrawal was upgraded to a Class III voluntary product recall on March 2.

A Class III recall is one in which the “… product is violative and use of or exposure to the product is not likely to cause any adverse health consequences,” according to FDA’s Regulatory Procedures Manual.

Although the concentration of pentobarbital found in the tallow was included in the investigator’s completed Form 483 (Inspectional Observations), the information was redacted from the copy supplied to Food Safety News.

According to information contained in the class action complaint, the retained sample of tallow contained pentobarbital at a level of 529 parts per billion (ppb). Levels of the drug in the current inventory ranged from 802 ppb to 852 ppb.

The tallow was allegedly supplied by MOPAC, an eastern Pennsylvania rendering facility belonging to JBS USA Holdings Inc.

When asked to confirm the reported levels of pentobarbital in the tallow samples, a spokesperson for FDA declined to comment. An FOIA request for the lab reports and for the Notice of Inspection (Form 482) was turned down on April 20, with the explanation that they were “not available” at the time.

It is standard procedure for an investigator to issue a Form 482 Notice of Inspection at the outset of any inspection. No explanation was given as to why this document was unavailable.

FDA has issued no updates on the status of its investigation or of the product recalls since the March 2nd recall notice.