FDA Says Sorry – we don’t have the budget to enforce law

“Due to competing priorities and resource limitations”…we can’t enforce law.

A few weeks ago the Director of FDA’s Center for Veterinary Medicine (CVM) Dr. Steven Solomon told an industry trade event “New evidence is showing” Pentobarbital may be “a much more pervasive problem in the animal food supply than originally thought.” FDA much have been bombarded with questions about Dr. Solomon’s statements, because today the FDA sent out some answers.

Posted on the FDA website 9/27/18, titled “Questions & Answers: Contaminants in Pet Food” the FDA states: “The FDA’s Center for Veterinary Medicine (CVM) receives a high volume of questions about pet food and contaminants from a range of stakeholders. Due to the breadth and depth of these inquiries, we are not able to respond individually to every inquiry because it would divert resources from addressing ongoing and emerging public health issues. In the interest of efficiency and transparency, CVM is posting our answers to some recent questions about contaminants in pet food. We will update this page as new information or questions emerge.

1. Can pet food contain residues of pentobarbital?

No. FDA considers pet food containing pentobarbital residues to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and will act to remove it from the market. Pentobarbital residues are not affected by rendering or canning temperatures and pressures (such as heat treatments capable of killing pathogenic organisms), and therefore we do not allow the use of animals euthanized with a chemical substance such as pentobarbital 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.

Below are links to examples of actions and recalls due to pentobarbital contamination:

• 2/16/18: FDA Alerts Pet Owners About Potential Pentobarbital Contamination in Canned Dog Food Manufactured by The J.M. Smucker Company, Including Certain Gravy Train, Kibbles ‘N Bits, Ol’ Roy, and Skippy Products
• 6/29/17: Evanger’s Dog & Cat Food Co – Warning Letter
• 4/24/17: Party Animal Recalls Dog Food Due To Potential Presence of Pentobarbital
• 3/3/17: Evanger’s Pet Food and Against the Grain Voluntarily Recalls Additional Products Out of Abundance of Caution due to Potential Adulteration with Pentobarbital
• 2/14/17: Against The Grain Pet Food Voluntarily Recalls One Lot of Pulled Beef Due to Potential Adulteration with Pentobarbital
• 2/3/17: Evanger’s Voluntarily Recalls Hunk of Beef Because Of Pentobarbital Exposure in one Batch of Food

2. Is it possible to prevent pentobarbital residues in pet food?

Yes. We believe that the new requirements that the Food Safety Modernization Act (FSMA) places on food manufacturers will help prevent this kind of contamination. FSMA requires certain animal food facilities to create and implement a food safety plan, including an analysis of potential hazards and determining if there are hazards requiring preventive controls to reduce or eliminate those safety hazards. FDA published a draft guidance identifying residues of pentobarbital as an example of a known or reasonably foreseeable hazard that would require a preventive control (see, Draft Guidance for Industry #245, “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals”).

The FDA totally forgot to mention the Federal Food Drug and Cosmetic Act, the FDA totally forgot to mention they themselves have allowed the pentobarbital poisonings to happen. As evidence to FDA’s responsibility of the “pentobarbital residues” in pet food, CVM Compliance Policy 690.300 (red font added):

Pentobarbital euthanized animals ARE “animals which have died otherwise than by slaughter.” The Food Safety Modernization Act (FSMA) will not prevent pentobarbital poisoning of pet food as FDA suggests as long as FDA allows Compliance Policies as above.

Continuing with FDA Q&A document:

3. Who is responsible for preventing residues of pentobarbital in pet food?

In general, pet food manufacturers are responsible for taking appropriate steps to ensure that the food they produce is safe 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. There are several different players connected to the issue of pentobarbital in animal food, including livestock producers, horse owners, veterinarians, renderers, haulers, and animal food manufacturers, and each has a role in preventing pet food contamination from pentobarbital residues. FDA has engaged with many of these stakeholders to communicate that no level of pentobarbital in pet food is acceptable and the agency is encouraging them to work together to fully investigate the issue and determine appropriate solutions. We will continue to follow up on complaints received, positive samples, and/or violative inspections.

4. Is the problem of pentobarbital in pet food more pervasive than originally thought?

The Director of FDA’s Center for Veterinary Medicine recently spoke about pet food contamination in general and mentioned pentobarbital. FDA believes that the increased focus through FSMA on hazard identification and preventive controls will raise awareness of contaminants such as pentobarbital, and lead manufacturers and ingredient suppliers to put the necessary safeguards in place.

5. Is pet food that contains tissues from diseased animals or from animals that died other than by slaughter considered adulterated under the FD&C Act?

Yes. Under the FD&C Act, food that is made from a diseased animal or an animal that died other than by slaughter is adulterated. However, federal agencies have discretion to enforce laws and FDA takes action based on scientific review and risk. We received a Citizen Petition (Docket No. FDA-2016-P-3578) requesting that we reconsider our policy. When we finish our review and respond to that petition, we intend to update this page to reflect that response.

It is important to remember that regardless of any enforcement discretion policy, the agency can and will act when necessary to protect public health.

In Question #5 response, FDA mentions “Citizen Petition (Docket No. FDA-2016-P-3578)“. That is our Citizen Petition to FDA. Consumers can re-read the Citizen Petition here (first two items on the page): https://www.regulations.gov/docket?D=FDA-2016-P-3578.  We submitted this Citizen Petition to FDA 2 years ago (October 2016).

And then out of the blue – in the middle of questions specifically relating to pentobarbital in pet food – the FDA brings up Salmonella…

6. Is pet food contaminated with pathogenic bacteria (e.g., Salmonella or Listeria monocytogenes) adulterated under the FD&C Act?

Yes. Pathogenic bacteria (e.g., Salmonella or Listeria monocytogenes) are considered adulterants in both human and animal food. Although many animals consuming this food may not become sick themselves, they can become carriers and expose their human family members to pathogenic bacteria. This is especially problematic with young children, the elderly, or people who are immunocompromised. For example, in March 2018, two children became ill with a strain of Salmonella that matched the strain found in samples of the raw pet food that was fed to the family dog.

And then FDA tells us that diseased animals in pet food or pet food made from animals that have died otherwise than by slaughter are not priority…

7. Why doesn’t FDA enforce every violation of the law?

Due to competing priorities and resource limitations, government agencies cannot act against every violation of the law. The same is true of FDA’s enforcement of the Federal Food, Drug, and Cosmetic Act. The use of enforcement discretion allows FDA to concentrate on the most egregious violations and the ones that present the highest risk to animal and human health.

Question to pet owners…

Which is more of a “egregious violation” (e·gre·gious 1. outstandingly bad; shocking) in your pet’s food?

1. Diseased and non-slaughtered decomposing animal carcasses?; or
2. Salmonella or Listeria?

Further, sister federal agency USDA feels diseased and non-slaughtered decomposing animal carcasses and what the processing of these waste ingredients produce – are an egregious violation of law.

Review. FDA states pentobarbital in pet food is an adulterant, but they don’t believe it is their responsibility to enforce law. The agency firmly believes Salmonella poses a greater risk “to animal and human health” than your pet consuming diseased and non-slaughtered (such as euthanized) animals. And the FDA tells us that they just don’t have the budget to stop allowing diseased animals and non-slaughtered animals into pet food.

If you disagree – if you believe diseased animals processed into pet food ingredients and decomposing dead animals including euthanized animals are an “egregious violation” – tell the FDA.

AskCVM@fda.hhs.gov

(Example email):

Dear Ask CVM,

The FDA recently stated “Due to competing priorities and resource limitations, government agencies cannot act against every violation of the law.” I guess FDA doesn’t realize that millions of pet owners as well have “resource limitations” – but we must abide by law and pay our bills, pay our rent, make our car payments and most significantly pay our taxes. We experience resource limitations yet we must manage within our budget (abide by law within our budget). I expect nothing less of FDA. Serious laws are being violated in pet food. FDA is allowing the feed industry to profit handsomely from selling adulterated ingredient pet foods to unknowing pet owners. Resource limitations is not an excuse to violate law or to allow law to be violated.

You also stated “The use of enforcement discretion allows FDA to concentrate on the most egregious violations and the ones that present the highest risk to animal and human health.” The highest risk to animals is most certainly FDA’s allowance of diseased and non-slaughtered animal carcasses in pet foods. The level of endotoxins in pet foods that contain these ingredients (produced from the kill step of gram-negative bacteria) are most certainly a significant health issue that FDA continues to ignore. Your sister federal agency – the USDA – states “The cooking step of the rendering process kills most bacteria, but does not eliminate endotoxins produced by some bacteria during the decay of carcass tissue. These toxins can cause disease, and pet food manufacturers do not test their products for endotoxins.” How can FDA have an opposite opinion of endotoxins as USDA?

There is no scientific evidence that live Salmonella or Listeria bacteria is more of a risk to pets than endotoxins. Then why is FDA ignoring the certain risk of diseased and non-slaughtered decomposing animals by continuing to allow this material into pet food with NO warning or disclosure to the pet owner?

[your name]

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
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