Valley Proteins receives FDA Warning Letter one year after pentobarbital found

Valley Proteins, Inc., a renderer located in Winchester, Virginia, was issued a Warning Letter from the US Food and Drug Administration (FDA) on November 18, 2019, one year almost to the day after FDA found pentobarbital in a sample of the company’s “animal fat product.”

The Warning Letter cited several violations of the Federal Food, Drug and Cosmetic Act revealed during the course of FDA inspections carried out in February 2019 and April 2019.

The animal fat product was adulterated due to the presence of pentobarbital

According to the Warning Letter, FDA advised Valley Proteins on December 18, 2018 that the agency had found pentobarbital in a sample of the Company’s animal fat product.

Despite the requirements spelled out in the Company’s formal Recall Plan, Valley Proteins “…did not take immediate action to notify customers or recall the product…”

On four separate occasions in February and in April 2019, FDA inquired as to whether the Company planned to recall the contaminated product. Valley Proteins declined to initiate a recall and refused to supply FDA with requested information regarding the amount of potentially affected product that was distributed by the Company before it learned of the pentobarbital contamination.

In response to FDA’s finding, Valley Proteins asserted that pentobarbital is an “unavoidable contaminant not known to present a health hazard,” an assertion strongly refuted by FDA in its Warning Letter, which included the following statement:

Adulteration of animal food with pentobarbital is not unavoidable. It is your responsibility to prevent adulteration of animal food with unsafe new animal drugs by ensuring that you are not receiving ingredients from your suppliers that contain unsafe new animal drugs or by developing methods to ensure that materials you receive containing unsafe new animal drugs are segregated and not used for animal food.”

The animal fat product was adulterated due to Animal Food Hazard Analysis and Risk-Based Preventive Controls (PC) violations

Specifically, Valley Proteins did not “…identify and evaluate hazards that may be specific to the source of [the] raw material, which included carcasses of animals euthanized with pentobarbital” in that the Company’s Hazard Analysis “…did not list Pentobarbital as a known and reasonably foreseeable hazard.” 

Valley Proteins began cleaning operations and started testing for pentobarbital in January 2019. However, it did not provide FDA with any indications as to how it planned to account for adulterated product that was distributed prior to starting its cleaning and testing program.

In fact, the Company continues to assert that it has no legal requirement to recall any products due to pentobarbital contamination.

In an update to its Hazard Analysis documentation, the Company states that it will no longer accept or process “dead stock” (i.e., euthanized animals). However, in a letter to its customers, the Company indicates that it “…will accept euthanized animals for collection and disposal, but chemically euthanized animals will not be rendered.”

FDA has requested, but has not yet received, information as to how Valley Proteins proposes to collect and dispose of euthanized animals.

Microbial hazards

FDA also highlighted concerns regarding the Company’s process control to prevent microbial hazards.

Specifically,
1. Bills of Lading for some products should have – but did not – including the statement, “not processed to control microbial hazards.”
2. The Company’s process controls lacked adequate parameters for controlling some microbial hazards, including Salmonella, E. coli and Listeria monocytogenes.
3. The process control parameters provided to FDA by the Company did not match the parameters as determined in the scientific study presented to validate those process controls.

Where did the adulterated animal fat go?

According to a spokesperson for FDA, the Company claims that none of the adulterated animal fat was distributed to pet food manufacturers. However, the firm did not provide any documentation to support its assertion.

The Warning Letter describes the adulterated sample as having been taken from a finished fat tank “…used to store animal fat distributed for use in animal food.” This could refer to food for livestock, including poultry, cattle, etc.

FDA is at risk of becoming a paper tiger

Setting aside the specific violations cited in this Warning Letter, Valley Proteins is just the latest in a string of companies that has refused an FDA request for a product recall, for documentation, or for some other aspect of cooperation in an investigation.

In recent months, we have seen at least two other instances of non-cooperation, even in the face of a direct risk to the health of consumers or their companion animals.

Lystn, LLC (Answers Pet Food) initiated a lawsuit against FDA, the US Department of Health and Human Services, and the Colorado Department of Agriculture, among others, rather than agree to a recall of its contaminated raw pet food products.
FDA was forced to take the extreme step of suspending facility registration of Topway Enterprises Inc. (a Texas-based seafood producer), citing “…an unwillingness and disregard by the company to cease operations and correct severe violations at their facility.”

These two examples are only the tip of the iceberg. It is not uncommon for company officials to decline FDA inspectors access to consumer complaint records, product formulations, and other information that inspectors often need to conduct their oversight. It is not unknown for a company to deny an inspector permission to document observations by photography, and later dispute the accuracy of the inspector’s written observations.

FDA’s remedies in the face of non-cooperation are limited. In theory, FDA is empowered under existing law to demand full access to these records. In practice, however, there is little an FDA inspector can do to enforce the agency’s authority other than by suspending the inspection and applying for a court order.

Similarly, FDA’s mandatory recall authority is a clumsy and slow instrument of last resort. The mandatory notification and appeal process would render moot an eventual mandatory recall of a perishable product. FDA’s best tool is to issue a Public Health Alert, warning consumers of the hazard posed by the offending firm’s products.

It’s time for a more assertive FDA stance

A driver caught for speeding is obliged by law to produce relevant documentation (driver license, vehicle registration and proof or insurance) upon request. Declining such a request lands the driver in even hotter water than before. Nor can the driver fight the charge by claiming that a speed limit is arbitrary and thus may be ignored.

Perhaps it’s time for FDA to arm its inspectors with the appropriate warrant or court order at the start of an inspection, especially in the case of a company with a history of prior non-cooperation.

Perhaps it’s time for an amendment to the Food Safety Modernization Act. One that will grant FDA the authority to suspend a company’s operations in the event of non-cooperation with a lawful inspection.

What Next For Evanger’s?

Evanger's Hunks of BeefThe pet health blogosphere is alive with questions and speculations over the February 3rd recall of five production lots of Evanger’s Hunk of Beef canned pet food. For anyone who has been in hibernation for the last several days, I’ll begin with a timeline.

June 6-13, 2016: Evanger’s produces five lots of Hunk of Beef canned food, using beef chunks furnished by a single unnamed USDA-inspected supplier.

December 31, 2016: A Washington state woman feeds Hunk of Beef to her five pugs as a special New Year’s Eve treat. Four of the dogs became severely ill within 15 minutes, and were rushed to an emergency veterinary center. One of the four dogs died; the other three required treatment in the veterinary ICU. The fifth dog, which ate the least amount of the food, did not require veterinary treatment.

January 3, 2017: The remains of the dead dog are submitted by the veterinarian to the Oregon State University Veterinary Diagnostic Laboratory for necropsy and lab analysis.

January 4, 2017: Evanger’s posts its first comment on the reports, indicating that the Company was in touch with the pet owner and that Evanger’s had submitted the batch in question to a third-party lab for testing. Evanger’s also reported that “the entire lot went to one distributor in Washington State, and no other cans from this lot would be anywhere else in the country.” The samples were received by the laboratory on January 13th, according to the lab reports on the Evanger’s website.

January 11, 2017: Samples of the stomach contents of the dead dog and of the remainder of the opened can of dog food are received by the Michigan State University Diagnostic Center for Population & Animal Health (MSU) for toxicology testing.

January 16, 2017: Evanger’s posted an update on its investigation, including initial lab test results for Salmonella, Staphylococcus aureus, Clostridium spp. and Enterobacteriaceae. The test results were negative.

January 17, 2017: Dr. John Buchweitz, Clinical Toxicologist at MSU reports finding pentobarbital in the stomach contents and a ‘large quantity chromatographically’ in the sample of food. In reporting this result, Dr. Buchweitz adds, “If this sample came directly from a can, this is an urgent matter and needs to be reported to the FDA Feed Safety Portal.” Click on Toxicology Report to read the full report.

January 21, 2017: Evanger’s shared another lab report on its website, stating that the sample did not contain botulinum toxin.

January 23, 2017: Evanger’s posted its final lab test, reporting that the Hunk of Beef sample was ‘Commercially Sterile’.

January 30, 2017: Evanger’s posted yet another update, disputing reports that pentobarbital had been found in their dog food, adding, “These “claims” are simply fear tactics and either unrelated or unsubstantiated claims against our company and our foods.”

February 3, 2017: At FDA’s request, Evanger’s recalled five production lots of its Hunk of Beef canned pet food.

So, what happens next?

I have reached out both to FDA and to USDA, since Evanger’s procured their beef from a USDA-inspected facility to get an answer to that question. FDA, according to its standard policy, declined to comment on an in-progress investigation. In response to my email query, I was told by a USDA-FSIS spokesperson, “FDA is currently the lead on the investigation in Evanger’s Dog and Cat Food. USDA-FSIS is working with their federal partners at FDA to determine whether more Agency action is required.“

Reading between the lines, I think it is safe to say that FDA inspectors have been, and probably still are, swarming over and through Evanger’s production facility at 221 Wheeling Road, Wheeling, IL. Based on Evanger’s history, which I summarized in yesterday’s report, I hope and expect that the investigation will be exhaustive.

 

Still Shocked and Saddened

I’m sorry, Susan Thixton, but I don’t buy your arguments (http://truthaboutpetfood.com/it-is-not-junk-science/). Let me respond to a few points and then I’ll shut up and allow readers to draw their own conclusions.

1. Let me begin by acknowledging that aflatoxin levels are, indeed, quoted in parts per billion. I should have made that clear. Fumonisins guidelines, on the other hand, are quoted in parts per million. See FDA document 7303.001 for this information.

2. The use of “qualifying pathogens” in the context of this pet food report is out of context with FDA’s purpose in establishing this list. The “qualifying pathogens” list was established in order to establish priorities for encouraging “…the development of new antibacterial and anti fungal drugs for the treatment of serious or life-threatening infections.” The term is not a commentary on the risk to human or animal health posed by these microorganisms when present in the environment or in a food product, whether human or animal.

3. The entire genus Staphylococcus and the entire genus Streptococcus are not qualifying pathogens. Only certain species within these two genera are mentioned in the FDA Final Rule. This is akin to reasoning that because a hawk is a bird and a hawk is a predator, therefore all birds are predators. Just because methicillin-resistant Staphylococcus aureus and vancomycin-resistant Staphylococcus aureus are on the qualifying pathogens list, that does not mean that ALL Staphylococcus are “qualifying pathogens,” even assuming the relevance of the designation to this pet food testing project.

4. In saying that a pathogen such as Acinetobacter is mainly associated with hospital-acquired infections, this does not mean that Acinetobacter is mainly or only found in hospitals. Rather, it means that most infections caused by Acinetobacter are hospital-acquired. Acinetobacter are widely found in the environment, in soil, and even on human skin.

5. I am not disputing the capabilities of Dr. Gary Pusillo as a veterinary nutritionist. Nor have I made any comments on the nutritional testing portion of the study, because veterinary nutrition is outside of my area of expertise, just as microbiology is outside of the expertise of Dr. Pusillo. Similarly, Dr. Purejav’s degrees are in the area of animal science, according to his LinkedIn profile. Would you ask a gastroenterologist to diagnose a neurological problem or read and magnetic resonance images of the brain? Of course not. Why, then, should one expect a veterinary nutritionist and an animal science expert to be the most appropriate individuals to develop, oversee and interpret the results of a microbiology testing program?

6. With all due respect to the reputation and status of Baylor University, the more closely I look at the microbiology findings -especially from the canned foods – the more skeptical I become as to the protocol used during testing. Canned foods should be sterile, with the possible exception of a few spores of highly heat-resistant bacteria. Yet a significant number of the canned food samples were found to contain a long list of microbes that are not especially heat-resistant. It takes special training and equipment and a highly controlled and sterile environment to conduct a reliable microbiology test on a canned food. Contamination of the sample by the lab analyst can occur all too easily. Not all labs are equipped for this level of testing, and not every lab technician or microbiologist has received the necessary training to perform the testing correctly. Baylor’s Microbiology program is housed within its College of Medicine, whereas this type of testing is more commonly taught in a food or pharmaceutical microbiology setting.

7. There is no such thing as searching for “all bacteria” in a food sample. Either a lab is provided with a list of bacteria to search for, or the lab will be asked to isolate and identify as many different bacteria from the sample as possible. Bacteria that are faster or more robust in their growth, or that are present at higher concentrations may outgrow and mask the presence of other bacteria in a sample. If the lab was provided with a list, then that list should have been included in the report.

Finally, Susan, we do not live in a sterile world. There are bacteria in and on just about everything with which we and our pets come into contact. Some of these bacteria are helpful – such as those that ferment milk or those that are used to produce beer or wine; some of them are benign – neither helpful nor harmful in most circumstances. And some – the minority – are pathogens, capable of causing infections in humans or animals. That is the world we live in.

As for the study that you commissioned, I applaud your good intentions. But, in my opinion, the outcome is still junk science.