Animal & Veterinary

Questions and Answers: Evanger’s Dog and Cat Food

When did the FDA become aware of the consumer complaint regarding the five dogs that became ill on New Year’s?
What did the FDA Form 483s and firm inspection reports say?
What does “inedible” mean in the context of the bill of lading?
Are any of Evanger’s beef suppliers inspected by USDA-FSIS?
Under which federal or state agency’s jurisdiction does this supplier fall?
Is an on-site investigation of the meat supplier in progress?
How many complaints has FDA received for these products?
Does the FDA allow the use of chemically euthanized animals in pet food? How common is this practice?
Is there any acceptable level of pentobarbital in pet food?
Who is responsible for ensuring that pet food is safe? What regulations apply in this arena?
What did the FDA find during its 1998 surveys of dog foods for the presence of pentobarbital?
What did the FDA find in the research paper entitled “Effect of oral administration of low doses of pentobarbital on the induction of cytochrome P450 isoforms and cytochrome P450-mediated reactions in immature Beagles”?
Does the FDA believe that pentobarbital is commonly found in dog foods?
What does it mean if a sample tests negative for pentobarbital?
What further action is the FDA taking or considering?


When did the FDA become aware of the consumer complaint regarding the five dogs that became ill on New Year’s?

The FDA became aware of the incident when a Washington State official referred a news article about the incident to the agency via our Safety Reporting Portal. We then contacted the owner of the five dogs in early January to get additional information regarding the initial health of her dogs and potential exposure to toxins. We worked with the owner and retailer to collect samples of the dog food and with Oregon State University to recover the gastric contents of the deceased dog and tested them through our Forensic Chemistry Center and Vet-LIRN laboratories. All of these samples tested positive for pentobarbital.

We immediately developed an inspection plan for Evanger’s production facilities and began our inspection on January 10. In the course of the inspection, we collected and tested two cans of Against the Grain canned Pulled Beef with Gravy, and these cans were also positive for pentobarbital. In review of Evanger’s records, we determined that the facility identified on a bill of lading as Evanger’s supplier of “Inedible Hand Deboned Beef” further identified as “FOR PET FOOD USE ONLY. NOT FIT FOR HUMAN CONSUMPTION" does not have a grant of inspection from the United States Department of Agriculture’s Food Safety Inspection Service. The meat products from this supplier do not bear the USDA inspection mark and would not be considered human grade.

The FDA was unable to determine from available records whether any other Evanger’s or Against the Grain products made with beef contain any of the beef that went into the recalled products. Evanger’s is also a contract manufacturer for other companies and the FDA is working to determine if those companies received impacted product.

The inspection concluded on February 14, and our observations were presented to the company in an FDA Form 483, Inspectional Observations. These are initial observations and do not represent a final agency determination regarding Evanger’s compliance with regulations. Our investigation is ongoing, and we cannot comment about any potential actions the agency may take in this case.

During the recall process, FDA works very closely with a facility to determine whether a recall is necessary and the scope of the products to be included in the recall. We encourage facilities to initiate a voluntary recall and if necessary update the product involved in the recall as information about potentially affected products unfold.

The FDA must fully investigate – performing tests, inspections, and interviews before we have enough information to verify whether there is a public safety concern. In this case, the FDA has been conducting an investigation that involves inspections, sample collection, testing, traceback, and more. The FDA is continuing to investigate this incident and cannot speculate on possible further actions at this time.

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What did the FDA Form 483s and firm inspection reports say?

The 483 issued to Evanger’s Dog and Cat Food of Wheeling, IL on February 14, 2017 is available online. The agency’s final conclusions for the inspection are not yet complete. Also available online is a 483 issued to Nutripack, LLC of Markham, IL on February 14, 2017.

What does “inedible” mean in the context of the bill of lading?

The United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) regulates the slaughter of animals for human consumption and provides grading and definition for various products.

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Are any of Evanger’s beef suppliers inspected by USDA-FSIS?

The FDA’s preliminary assessment indicates that none of these suppliers are USDA-FSIS registered facilities.

Under which federal or state agency’s jurisdiction does this supplier fall?

The FDA regulates animal protein ingredient suppliers. These facilities may also be subject to state jurisdiction, which varies by state.

The United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) regulates the slaughter of animals for human consumption and provides grading and definition for various products. USDA-FSIS, not the FDA, tested the Evanger’s product for speciation.

USDA-APHIS is not involved in this investigation. USDA-APHIS provides a voluntary service to facilities that wish to export to certain countries, inspecting their facilities according to standards established by the importing country. APHIS does not have direct regulatory responsibility over pet food. The APHIS-assigned number that the supplier was using signifies export certification. However, the supplier’s export certification status is no longer active, thus the number is not valid.

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Is an on-site investigation of the meat supplier in progress?

The FDA has concluded its inspection of the supplier and determined that they appear to have systems in place to ensure that euthanized animals are segregated from animal protein going for animal food use.

How many complaints has FDA received for these products?

The FDA has received ten complaints for Evanger’s products with five complaints that are suggestive of pentobarbital poisoning. These complaints relate to the Hunk of Beef product primarily, although one complaint also describes feeding an additional product, Evanger’s Braised Beef Chunks in Gravy for Dogs. FDA is following up on four complaints based on available product and veterinary medical records to obtain further information. The agency has not received similar complaints related to the suspect lots of Against the Grain Grain Free Pulled Beef with Gravy canned dog food.

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Does the FDA allow the use of chemically euthanized animals in pet food? How common is this practice?

No. It is not acceptable to use animals euthanized with a chemical substance in pet or other animal foods. FDA's understanding is that animal protein ingredient suppliers typically implement practices at their facilities to ensure that euthanized animals are either not accepted at the facility, or are segregated from animal protein going for animal food use.

The detection of pentobarbital in pet food renders the product adulterated. It is the responsibility of the manufacturer to take the appropriate steps to ensure that the food they produce is safe for consumption and properly labeled.

Is there any acceptable level of pentobarbital in pet food?

No. There is currently no set tolerance for pentobarbital in pet food and its detection renders the product adulterated.

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Who is responsible for ensuring that pet food is safe? What regulations apply in this arena?

Pet food manufacturers are responsible for taking appropriate steps to ensure that the food they produce is safe for consumption and properly labeled. One way that a manufacturer can do this is by taking steps to verify the identity and safety of the ingredients they receive from their suppliers.

It is the responsibility of the salvage facility collecting these animals to determine how they died and to separate those animals appropriately. Pentobarbital residues are not affected by rendering or canning temperatures and pressures (such as heat treatments capable of killing pathogenic organisms), and
therefore animals euthanized with a chemical substance such as pentobarbital cannot be used in the manufacture of pet foods. There is currently no set tolerance for pentobarbital in pet food and detection of its presence renders the product adulterated.

In addition to these requirements, specific regulations governing the production of safe animal food already exist: Under the Food Safety Modernization Act, animal food manufacturers will be subject to a rolling implementation schedule to the Preventive Controls for Animal Foods final rule. This rule established Current Good Manufacturing Practice (CGMP) requirements that apply to the manufacturing, processing, packing, and holding of animal food. It also requires facilities to develop and implement a food safety plan, including performing an analysis of potential hazards and determining if there are hazards requiring a preventive control. Preventive controls are intended to significantly minimize or prevent the hazards identified at the facility. If a preventive control is in place, it must be monitored by the firm and corrective action would have to be taken as needed.

FSMA compliance dates for food facilities vary according to business size. The first set of facilities are required to comply with the food safety plan provisions by September 2017. Facilities that are considered a "small business" must comply with the food safety plan provisions by September 2018. Facilities that are considered a "very small business" must comply with the food safety plan provisions by September 2019.

In addition, in August 2016, the FDA released draft guidance on current Good Manufacturing Practice requirements for food for animals. This draft guidance is intended to help manufacturers comply with the Current Good Manufacturing Practice requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule published on September 17, 2015. Good manufacturing practices apply to buildings, facilities and personnel, and include cleaning and maintenance, pest control, and the personal hygiene of people who work there.

Large companies were required to comply with these new requirements by Sept. 19, 2016. Companies that are considered small businesses must comply by September 19, 2017 and very small businesses must comply by September 19, 2018.

What did the FDA find during its 1998 surveys of dog foods for the presence of pentobarbital?

Nineteen years ago, the FDA collected dry dog food samples to determine whether products contained pentobarbital. The sampling was not representative of the entire pet food market because the sample collectors specifically sought out dry dog foods with certain animal-derived ingredients. The sampling method and the age of the data generated by the survey means that the data cannot be used to draw inferences about dog food being produced and sold in the U.S. today.

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What did the FDA find in the research paper entitled “Effect of oral administration of low doses of pentobarbital on the induction of cytochrome P450 isoforms and cytochrome P450-mediated reactions in immature Beagles”?

The objective of the paper was to determine the effect of oral administration of low doses of pentobarbital on cytochrome P450 (CYP) isoforms and CYP-mediated reactions in immature beagles.

In a study designed to develop an analytic method for the determination of pentobarbital residues in dog food, several lots of commercial dog food were found to contain confirmable concentrations (10 to 60 ppb) of pentobarbital. On the basis of these and other results, a limited study was initiated to assess the potential effects of low degrees of barbiturate exposure in dogs. This second study showed that ingestion of 50 micrograms of pentobarbital per day (approximately 86 ppb/kg dry kibble) did not cause induction of liver or intestinal enzymes, which are very sensitive markers of pentobarbital exposure.

Does the FDA believe that pentobarbital is commonly found in dog foods?

No. As noted in the 1998 survey, the sampling was not representative of the entire pet food market because the sample collectors specifically sought out dry dog foods with certain animal-derived ingredients. This means that the data could not be used to draw inferences about dog food being produced and sold in the U.S. then or today. The FDA has not surveyed pet foods for the presence of pentobarbital since that time. However, there is currently no set tolerance for pentobarbital in pet food and its detection renders the product adulterated (therefore, the substance should not be present in pet foods at all).

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What does it mean if a sample tests negative for pentobarbital?

A negative test simply indicates that the particular sample tested was negative for pentobarbital. Due to the nature of “chunk beef” products, meat from various animals can be irregularly distributed throughout the lot of food. This means that some cans could contain meat from only one animal, while others can might contain some meat from that animal, and others none at all. If meat from a euthanized animal is used, it could end up in some cans, but not others, and in varying amounts. In a lot of hundreds or even thousands of cans of food, if even one can tests positive, we have to consider the possibility that some, but not necessarily all other cans in that lot will also test positive.

What further action is the FDA taking or considering?

The FDA is continuing to investigate this incident and cannot speculate on possible further actions at this time.

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Page Last Updated: 03/02/2017
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