FDA Confirms Pentobarbital in Dog Food

Pet owners warned to avoid certain Evanger’s and Against the Grain dog food

FDA is advising pet owners and pet caretakers not to feed their pets with certain lots of Evanger’s and Against the Grain dog food after confirming the presence of the euthanasia agent pentobarbital in both products.

Following discussions with FDA, Evanger’s announced a voluntary recall on February 3, 2017 of five lots of its 12-ounce Hunk of Beef canned dog food, all with an expiration date of June 2020: 1816E03HB, 1816E04HB, 1816E06HB, 1816E07HB, and 1816E13HB. On February 9th, Against the Grain voluntarily recalled lot #2415E01ATB12 BEST DEC 2019 of its Grain Free Pulled Beef with Gravy dog food after the agency detected pentobarbital that product. The Pulled Beef with Gravy was manufactured in the same facilities as Evanger’s products and using beef from the same supplier.

In addition to the presence of pentobarbital, FDA reports a bill of lading from Evanger’s supplier of ‘Inedible Hand Deboned Beef – For Pet Food Use Only. Not Fit for Human Consumption’. This is despite Evanger’s claim that the beef in its Hunk of Beef product came from a ‘USDA approved’ supplier. FDA also has determined that the supplier’s facility does NOT have a grant of inspection from USDA’s Food Safety and Inspection Service. The meat from the supplier does not bear a USDA inspection mark and would not be considered human grade. Lab testing by USDA-FSIS of Evanger’s Hunk of Beef confirmed that the meat in the product was beef.

Other issues cited in a preliminary investigation report (FDA Form 483) released today by FDA include evidence of unsanitary conditions, inadequate refrigeration, improper storage, and inadequate control of ambient temperature during hand-packing operations at Evanger’s Wheeling, IL facility and unsanitary conditions and ‘avian activity’ at its Markham, IL manufacturing location.

FDA’s investigation is ongoing and will include examination of the suppliers of beef to Evanger’s and Against the Grain to determine the source of the pentobarbital. The agency is also coordinating with USDA to address possible areas of shared jurisdiction.

Consumers with cans of the recalled product should refer to the Evanger’s and Against the Grain recall notices for information on returning the product.

This article first appeared on Food Safety News and is reposted here with permission.

FDA Flexes Muscles To Achieve Kasel Pet Treat Recall

The extensive ‘voluntary’ pet treat recall announced on February 19th by Kasel Associated Industries (Denver, CO) was triggered by FDA’s threat to invoke its new mandatory recall authority, according to Siobhan DeLancey, spokesperson for FDA’s Office of Foods and Veterinary Medicine.

Earlier today, DeLancey informed eFoodAlert by email that Kasel chose to voluntarily recall its products upon receipt of a “last chance” letter from FDA (formally, a Prehearing Order to Cease Distribution and Give Notice, also referred to as a 423(a) letter). This is the first time that FDA has initiated mandatory recall proceedings under the authority granted to it by the Food Safety Modernization Act.

FDA inspected Kasel’s manufacturing facility during a 10-day period beginning September 19 2012, after the Colorado Department of Agriculture found Salmonella in a finished product sample of Boots & Barkley 6-count 5-inch American Beef Bully Sticks. Kasel recalled four lots of the product on September 21st (Lots #BESTBY20APR2014DEN, BESTBY01JUN2014DEN, BESTBY23JUN2014DEN, and BESTBY23SEP2014DEN). On October 2nd, the company recalled Nature’s Deli Chicken Jerky Dog Treats (2.5 lb; Lot #BEST BY 091913 DEN) after FDA found Salmonella in a sample of this lot code. Additional testing carried out by Colorado prompted a third recall on October 17th, this time of Boots & Barkley Roasted American Pig Ears and Boots & Barkley American Variety Pack Dog Treats (Lot #BESTBY 13SEP2014DEN for both products). Colorado found Salmonella in another retail sample of Nature’s Deli Chicken Jerky Dog Treats (Lot #BESTBY061913DEN) in November 2012; however, Kasel refused to initiate another recall.

The September 2012 inspection carried out by FDA revealed several sanitary issues, including live insects and evidence of rodent activity in the manufacturing facility, DeLancey said. Furthermore, FDA recovered Salmonella from all of the finished product samples collected during its inspection, as well as from 1 out of 2 in-process bulk product samples and 48 of 87 environmental swab samples. Some of the Salmonella-positive swab samples were taken from food contact surfaces. In all, FDA found 14 different strains of Salmonella: Anatum, Mbandaka, Senftenberg, Typhimurium, Agona, Muenchen, Irumu, Tennessee, Montevideo, Infantis, Muenster, Derby, O rough;d;e,n,x, and London. Isolates recovered from products made on June 19th matched those from September 19th, indicating an ongoing contamination issue.

FDA carried out a follow-up inspection on February 14, 2013, including additional finished product and environmental swab sampling. Results of those samples are still pending; however, FDA noted that the company had taken several corrective measures.

I found it strange that the latest recall covered only the period from April 20, 2012 through September 19, 2012. DeLancey explained that this was the time frame during which positive results were collected. If FDA finds additional Salmonella-positive samples as a result of its follow-up inspection, I would expect either an expansion of the most recent recall or – in the event that Kasel proves recalcitrant – another FDA-issued warning.

FDA has received a “small number” of complaints from pet owners whose dogs became ill after being exposed to the recalled treats. No human illnesses have been reported yet.

eFoodAlert Advice to Consumers

Check your supply of pet treats against the products listed in the most recent recall notice. Discard any that are mentioned on the list. If you are not sure of the origin or lot code of the treat, discard it.
If your dog develops symptoms of a Salmonella infection (typically diarrhea or vomiting) after consuming a Kasel-manufactured treat, seek veterinary attention; also, report the illness to FDA.
If you or a family member develop symptoms of a Salmonella infection after handling a Kasel-manufactured pet treat – or a sick pet – seek medical attention, and mention the possible link to the pet treat.
Always wash your hands immediately after handling any pet food or pet treat, especially one of the affected brands listed in the recall notice.

If you believe that your pet or a member of your household has become ill as a result of exposure to one of the brands of pet treat mentioned in the recall notice, please post a comment.

Sunland vs. FDA: Who Should We Believe?

At no time in its twenty-four year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms.

– Jimmie Shearer, President and CEO, Sunland, Inc.

On November 14, 2012, FDA issued the following update to its investigation of the Salmonella Bredeney peanut butter outbreak.

“November 14, 2012 – FDA posts observations from recent inspection at Sunland Inc.

The FDA has made the observations from its recent inspection of Sunland Inc. publicly available. This inspection was conducted between September 17 and October 16, 2012, and became part of the investigation of the Salmonella Bredeney outbreak linked to peanut butter made by Sunland Inc.

During this inspection investigators found that conditions in the company’s facility, the company’s manufacturing processes, and the company’s testing program for Salmonella may have allowed peanut butter that contained Salmonella to be distributed by the company.

The FDA found that between June of 2009 and August of 2012, Sunland Inc. had distributed, or cleared for distribution, portions of 11 lots, or daily production runs, of peanut or almond butter after its own testing program identified the presence of at least one of nine different Salmonella types (Arapahoe, Bredeney, Cerro, Dallgow, Kubacha, Mbandaka, Meleagridis, Newport, and Teddington) in those lots. Two of these lots showed the presence of the outbreak strain of Salmonella Bredeney.

Equally important, five product samples collected and analyzed by FDA from Sunland Inc. showed the presence of Salmonella, but had not been identified as containing Salmonella by Sunland Inc.’s internal testing. Among those products were peanut butter and shelled raw peanuts. Two of these samples showed the presence of the outbreak strain of Salmonella Bredeney.

Additionally, during its inspection of the plant in September and October 2012, the FDA found the presence of Salmonella in 28 environmental samples. Three of these samples showed the presence of the outbreak strain of Salmonella Bredeney.

Upon identifying the contaminated peanut butter, FDA investigators informed the company and called for corrective action. On October 4, 2012 Sunland Inc. expanded its ongoing recall to include all products made in the Sunland Inc. nut butter production facility between March 1, 2010 and September 24, 2012.

Upon identifying the contaminated shelled raw peanuts, FDA investigators informed the company and again called for corrective action. On October 12, 2012 Sunland Inc. expanded its ongoing recall to include raw and roasted shelled and in-shell peanuts sold in quantities from 2 ounces to 50 pounds which are within their current shelf life or have no stated expiration date.

Additionally, investigators found that employees improperly handled equipment, containers, and utensils used to hold and store food. Employees handling peanut products wiped gloved hands on street clothes and other times failed to wash their hands or change gloves. There were no hand washing sinks in the peanut processing building production or packaging areas and employees had bare-handed contact with ready-to-package peanuts.

There were no records documenting the cleaning of production equipment. The super-sized bags used by the firm to store peanuts were not cleaned despite being used for both raw and roasted peanuts. There was a leaking sink in a washroom which resulted in water accumulating on the floor, and the plant is not built to allow floors, walls and ceilings to be adequately cleaned.

Finally, investigators found that raw materials were exposed to potential contamination. Raw, in-shell peanuts were found outside the plant in uncovered trailers. Birds were observed landing in the trailers and the peanuts were exposed to rain, which provides a growth environment for Salmonella and other bacteria. Inside the warehouse, facility doors were open to the outside, which could allow pests to enter.

The FDA is currently evaluating Sunland Inc.’s official response to FDA’s observations from the inspection.”

Yesterday – November 15th – Sunland responded with this statement:

“At no time in its twenty four year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms. The Company has followed internal testing protocols that it believed resulted in the isolation and destruction of any product that did not pass the test designed to detect the presence of any contaminants. In every instance where test results indicated the presence of a contaminant, the implicated product was destroyed and not released for distribution. The Company believed at all times that its response was sufficiently robust such that any product which might be contaminated was isolated and destroyed.

Sunland, Inc. continues to cooperate openly with FDA to address matters related to the recent recall of its products and the inspection of its manufacturing facilities. Sunland has submitted a comprehensive point by point response to the Form 483 observations issued at the close of the inspection. The Company’s response is currently under review by the agency. We believe that drawing any inferences much less conclusions about the Company’s practices based solely on the observations as set forth in the Form 483 without considering the Company’s response would be wholly premature and unduly prejudicial to Sunland. The Company believes that its response to the Form 483 will not only help the agency understand the Company’s decision-making process but also lead the agency to confirm that such decision-making was, at all times, conducted in good faith. In deference to the agency’s review process, the Company will not publicly discuss its responses until the agency has completed its review.”

Sunland has not denied that contaminants were found. Nor has it denied that multiple strains of Salmonella were present at various times and in various locations, in its finished products, its raw peanuts, and its production environment.

How does a food processor allow this magnitude of contamination to exist in its finished products and in its production facility for more than three years? What does this say about the ethics of the company’s owners and management?

Or has ethical behavior become an oxymoron in the food industry?