Category: food safety

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.

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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.

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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.

Year-long investigation of euthanasia drug in pet food over

Reinspection of Evanger’s-Nutripack production plant shows no ‘imminent public health’ concerns

by Phyllis Entis

On Feb. 16 the Food and Drug Administration (FDA) issued a close out letter, officially putting an end to its investigation of a manufacturing plant operated by Evanger’s Dog & Cat Food Co. Inc.

The FDA action followed the transfer of all manufacturing operations from the troubled pet food production operation in Markham, IL, to a plant operated by Nutripack LLC in June 2017.  The FDA’s investigation began after a consumer complained that the company’s canned dog food had made her dogs severely ill, killing one of them.

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Lab samples taken during an autopsy of the dog and from the can of food it had eaten showed the presence of a significant quantity of pentobarbital, a barbiturate used to euthanize animals. Animal food is considered to be adulterated under federal law if it contains even a trace amount of pentobarbital, according to FDA.

Subsequent tests carried out by FDA confirmed the presence of pentobarbital at varying concentrations in 13 out of 14 Evanger’s dog food samples tested. The barbiturate was present at levels as high as 81 parts per million.

In 1998 and 2000, FDA conducted a pair of surveys to determine whether and to what extent dry dog food contained pentobarbital. The highest concentration they found in any sample was 32 parts per billion.

The amount found in the most heavily contaminated Evanger sample was more than 2,500 times the highest level found in dry dog food during a 2000 FDA survey.

The lethal oral dose of pentobarbital for a dog is about 85 milligrams of the drug per kilogram (2.2 lbs) of body weight. A healthy 10-pound dog would need to consume approximately its own body weight in food in order to receive a lethal dose of pentobarbital, if the food was contaminated at a level of 81 parts per million.

The pentobarbital finding triggered an FDA inspection both of the Evanger and of the Nutripack manufacturing facilities in January-February 2017. As reported in February 2017 by Food Safety News, inspectors documented several violations at both locations.

Both Evanger’s and Nutripack are owned and operated by members of the Sher family.

Joel Sher, vice president and co-owner of Evanger’s Dog & Cat Food Co. Inc., describes the company’s products during a trade show.

In October 2017, FDA carried out a “comprehensive, compliance follow-up inspection” at Nutripack, according to information contained in an Establishment Inspection Report (EIR) obtained by Food Safety News under the Freedom of Information Act.

Inspectors found several objectionable conditions, which they discussed with the company’s management at the end of the multi-day investigation. These included:

  • No evidence of any heat or temperature distribution studies on any of the retorts used to process the company’s low-acid canned pet food product, and no data to support that the venting schedule used by the company was sufficient to ensure that all air is removed from the retorts prior to processing.
  • No accuracy tests performed on the retort temperature-indicating devices. These devices are required to be tested for accuracy at least once a year.
  • The plant was not maintained in good repair to prevent the animal food from becoming adulterated. Water was observed to be dripping directly from the ceiling onto various packaged and palletized finished products, on raw ingredients stored in a plastic drum and on empty cans stacked on top of pallets in the warehouse.
  • Measures to exclude pests from the plant were ineffective. A live mouse was observed running through the production area while it was in operation and there were “too numerous to count” rodent-like pellets along one wall behind the retorts.
  • The grounds around the building were not maintained in a condition that would protect against pests that might penetrate into the facility.

Management made the following corrections during the course of the inspection, and promised to respond to all of the observations in writing within 15 business days:

  • Dual check valves were installed on a hand washing sink next to a hand pack line after FDA inspectors noted the lack of proper back-flow prevention devices
  • In-process products were labeled during production to monitor traceability
  • Documentation was provided regarding planned installation of insulating material above the production area to prevent condensate.

According to the October 2017 EIR, the issues cited by FDA investigators during the two Nutripack inspections “…were observed to be corrected by the firm or [were considered] to pose no imminent public health concerns.”

On the company’s website, the Sher family highlights its efforts to “create an exceptional level of quality control system and production in a new state of the art manufacturing facility in Markham, IL,” and pledges to “work closely and in full cooperation with the FDA.”

Nevertheless, upon the arrival of the FDA investigators at Nutripack on Oct. 11, 2017, Joel Sher, identified as manager/president in the FDA report, shut down production on the “Hand Pack” pet food line. When one of the investigators asked for a reason, Sher replied that he “did not want a write up.”

During the October 2017 inspection, FDA investigators were refused permission to document their observations by photography. Sher permitted investigators to photograph only certain company-provided documents that were not able to be copied using the firm’s printer. 

Sher also refused to read, to have read to him, or to sign, a one-page affidavit.  The unsigned affidavit was appended to the EIR as an exhibit, but the contents of the document were not revealed in FDA’s response to the Freedom of Information Act request.

The FDA encourages consumers to report complaints about pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.

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