Pentobarbital continues to ‘dog’ pet food industry; beef tallow blamed

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

On May 8 Champion Petfoods USA Inc. was informed that three shipments of beef tallow delivered by their supplier were contaminated with pentobarbital, a tranquilizer often used to euthanize sick or fatally injured animals.

Ingestion of the barbiturate can cause drowsiness, dizziness, excitement, loss of balance, or nausea, or in extreme cases, possibly death of dogs and cats. Beef tallow is promoted as an inexpensive, palatable, and stable source of energy, with a nutritional profile “sufficient for safe use as a pet food ingredient,” according to an industry website, BeefTallow.com.

Champion, a Canadian pet food company whose U.S. production facility is in Auburn, KY, manufactures Acana and Orijen brands of dry dog food.

The company ceased manufacturing products that require beef tallow, and quarantined the three pentobarbital-contaminated lots of tallow. However, by the time the company learned of the problem, some of the tallow already had been used.

Champion initiated pentobarbital testing on the retained samples from the beginning, middle and end of the affected production lots, and retrieved finished product from its third-party distributors.

The retained samples tested for pentobarbital were found to be negative. Some of the finished products containing contaminated tallow were distributed to the store/consumer level, but no retail-level product recall was initiated.

On May 16 the Food and Drug Administration initiated an inspection of Champion’s facility, according to information contained in the agency’s Establishment Inspection Report (EIR), which was obtained by Food Safety News in response to a Freedom of Information Act request.

During the inspection, the company informed FDA that Champion was no longer doing business with the Pennsylvania supplier of beef tallow and consulted with the agency on how to properly dispose of the pentobarbital-contaminated tallow.

The name of Champion’s tallow supplier was blacked out in the EIR.

Champion advised FDA inspectors that it will require its new supplier of tallow to include test results for pentobarbital on Certificates of Analysis accompanying all shipments of the ingredient. FDA investigators appeared satisfied with Champion’s response to the contaminated tallow episode, classifying the outcome of the investigation as “No Action Indicated.”

Since the beginning of 2017, pentobarbital contamination has triggered the recall of canned pet foods manufactured by Evanger’s Dog and Cat Food Co. and Big Heart Brands.

The source of pentobarbital contamination in the Evanger’s products was never established.

Beef tallow was the apparent source of pentobarbital contamination in Big Heart Brands’ canned pet foods. According to information contained in a class action complaint filed against the manufacturer of Gravy Train and other canned dog foods, Big Heart’s tallow supplier was MOPAC, a Pennsylvania rendering facility belonging to JBS USA Holding Inc.

Big Heart Brands packs several popular brands of pet food that are distributed nationwide. Those brands include Gravy Train, Kibbles ’N Bits, Skippy and Ol’ Roy brands. Big Heart Pet Brands distributed the Gravy Train, Kibbles ’N Bits and Skippy dog food to retailers nationwide. Walmart Stores Inc. distributed the Ol’ Roy dog food.

Evangers denied knowledge of horse meat despite its license

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

Even though the owners of Evanger’s Dog and Cat Food Co. Inc. had a state license to process horse meat from Feb. 14, 2016, through Aug. 17, 2017, they denied any knowledge of how horse meat found its way into their products.

The pet food company’s license application submitted to the Illinois Department of Agriculture described Evanger’s operations as “canning of pet food” and indicated the horse meat would be sold as “canned pet food” according to information obtained from the department in response to a Freedom of Information Act request.

It is not illegal to use horse meat as pet food in the United States, as long as it’s presence is disclosed on the labeling, a spokesperson for the Food and Drug Administration said.

Evanger’s horse meat processing activities predated the issuance of the state license.

In April 2015, the Illinois agriculture department received a complaint from the Wheeling, IL, fire marshal about improper food storage and disposal, clogged and maggot-filled grease traps, and other unsanitary conditions at Evanger’s Wheeling Road facility. The state initiated an inspection of the facility on May 27, 2015.

During the investigation of the company’s operations, inspectors noted the manufacture of a dog food with horse meat as an ingredient.

As a result of conditions observed during the May inspection, the state of Illinois filed a formal complaint against Evanger’s, charging the company with violations of the Illinois Commercial Feed Act of 1961, the Illinois Food, Drug, and Cosmetic Act, and the Illinois Horse Meat Act.

The complaint stated that Evanger’s “… canned, packed or otherwise processed or prepared for sale a pet food with horsemeat listed as its main ingredient” without having secured a license to do so, and that the company did so under unsanitary conditions.

According to information contained in the report on a follow-up inspection, conducted in January 2016, Evanger manufactured only canned dog and cat foods in the Wheeling facility, receiving raw and frozen pork, chicken, beef and horse meats. The horse meat was imported from foreign countries, the report stated.

One year later, in January 2017, FDA launched an investigation into pentobarbital contamination in a canned, wet dog food manufactured by Evanger’s in June 2016. The investigation was in response to a consumer complaint following the death of a dog who had been fed some “Evanger’s Hunk of Beef au Jus” dog food.

During the investigation, FDA arranged for lab tests to determine the species of meats present in several samples of the same batch of food eaten by the dead dog. Traces of horse antigens were found in one of the samples.

As reported by Food Safety News in February 2017, those level of horse antigens would be consistent with incidental cross-contamination if horse meat was processed in the same facility as the beef-based dog food.

The owners of Evanger’s denied any knowledge of how horse meat had found its way into their products, and cast blame on their beef supplier, Bailey Farms LLC. On April 25, 2017, Evanger’s filed a lawsuit against Bailey, alleging that it had shipped pentobarbital-contaminated horsement instead of the “pet food quality beef” ordered by Evanger’s.

At the time the lawsuit was filed, and throughout the entire period during which the company manufactured dog food that was later found to be adulterated with pentobarbital, Evanger’s license to process horse meat was active and in force.

Evanger’s horse meat license expired in August 2017 and has not been renewed.

FDA investigates Smucker-owned Big Heart over pentobarbital

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

An investigation into pentobarbital adulteration in canned, wet pet food manufactured by Big Heart Pet Brands Inc. remains “open and ongoing” according to a spokesperson for the U.S. Food and Drug Administration.

Big Heart is a wholly owned subsidiary of The J.M. Smucker Company Inc.

On Feb. 16, FDA alerted pet owners to the possible presence of pentobarbital in certain canned dog foods, including Gravy Train, Kibbles ’N Bits, Ol’ Roy and Skippy products, after a media outlet reported having found the chemical in several samples of Gravy Train canned, wet dog food.

Upon learning of the findings, Smucker initiated a product withdrawal pending the outcome of an internal investigation. The withdrawal was upgraded to a voluntary recall after the company verified the presence of pentobarbital in its finished products and in beef tallow, an ingredient common to all of the affected products.

Pentobarbital is a barbiturate used to euthanize animals. FDA considers a pet food to be adulterated if it contains even a trace amount of the drug.

On Feb. 23, FDA initiated an inspection of the Big Heart manufacturing facility in Bloomsburg, PA. The inspection was conducted jointly with the Pennsylvania Department of Agriculture (PDA) and was completed on March 12th.

According to information contained in the Establishment Inspection Report (EIR), obtained by Food Safety News in response to a Freedom of Information Act request, Big Heart produces dog food under contract for third-parties in addition to manufacturing the Gravy Train, Ol’ Roy, Kibbles ’N Bits, and Skippy dog food brands as well as several brands of cat food.

A spokesperson for FDA, citing the ongoing status of the investigation, declined to comment on whether any of the private-labeled products were evaluated for possible pentobarbital contamination. Nor would the spokesperson comment on whether FDA conducted its own independent analysis of any ingredients or finished products as part of its investigation.

Big Heart did not test any other ingredients for pentobarbital once it found the chemical in the beef tallow ingredient.

All of the beef tallow used in the adulterated pet food was obtained from a single supplier.

Big Heart notified its supplier of the test results and followed up with an inspection of the supplier’s facility. Concluding that the supplier did not have adequate controls over its supply chain, Big Heart management switched to a different tallow supplier. In addition, the company reconfigured some product formulas to eliminate beef tallow.

A class action lawsuit filed in Northern California on May 1 against Big Heart Pet Brands Inc. alleges that the tallow was supplied by MOPAC, an eastern Pennsylvania rendering facility belonging to JBS USA Holdings Inc.

JBS operates two facilities in eastern Pennsylvania, one in Souderton and the other in Elizabethville. FDA declined to comment on whether either or both of these facilities were included in the investigation.

According to information contained in Establishment Inspection Reports obtained in response to a Freedom of Information Act request, the Elizabethville location manufactures poultry feed.

JBS Souderton is a rendering operation. It receives bovine, porcine and avian trimmings, bone, hides, offal, and blood from its nearby slaughter/meat packing facility and from other slaughter facilities, and also receives used cooking oil and yellow grease from restaurants.

Souderton produces a number of animal feed ingredients, including tallow, blood-meal, feather-meal, bone-meal and animal protein.

During the February-March inspection of Big Heart, FDA and PDA investigators were denied access to several documents, according to the EIR.

On instruction from the Smucker corporate headquarters, Big Heart management refused to furnish PDA and FDA investigators with qualitative or quantitative product formulae and refused to permit them to review either the company’s consumer complaint files or its Standard Operating Procedures for retaining samples.

The Plant Director, Dave Brookover, also declined to sign, or even to read, an FDA Affidavit (FDA Form 463a) setting out the information supplied by him during the course of the inspection. On instructions from the corporate office, Brookover left the room when the FDA investigator recited the contents of the Affidavit.

Some companies have specific policies on what they will or will not share with FDA, a spokesperson for the agency explained, adding that the nature and number of refusals were not out of the ordinary and did not obstruct the investigation.