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.