Rad Cat announced Monday that they have shut their doors. This is the first ubiquitous raw pet food company to close its doors since the FDA placed its focus on raw food sampling assignments in 2012.
What happened? Here’s what’s important for you to know.
Understanding the recall process –
- Sampling – Sampling is done by a State Department of Agriculture (DOA) at the retail level. Regulators sample poultry products almost exclusively, because poultry is most likely to test positive for pathogens.* Retailers are unconditionally allowed to film regulators on their property (rented or owned) to ensure Regulators comply with their own protocols and are held accountable for their actions. Its suggested to record them all the way to their car to ensure the product is placed in a dry ice cooler. Regulators must purchase the product (tax free), or have the retailer sign a paper that waives the retailers right to get credit.
- Testing – Once the product is sampled it is sent to an in-state lab for testing. Testing protocol includes thawing the product and homogenizing it for sampling, then adding a wash that specifically kills all competitive bacteria that would otherwise naturally inhibit the proliferation of pathogens. They then provide a nutrient blend that is specific to harboring pathogens. The product is then placed at 115*F for 16hrs-5dys to see what they can grow. It is inarguable that none of these conditions would occur in real life.
If the product tests positive it is assumed positive, even though protocol specifically states that it may be a false positive, and does not need to be retested to verify. If the product tests negative, Regulators are allowed to assume the test was wrong and retest as many times as desired until they get a positive. Once it tests positive, the agency can begin enforcement.
However, to make enforcement legal, the pathogen must be serotyped to identify exactly which pathogen strain it is and whether or not it is a risk to public health. If it can not be scientifically validated to be a strain that is a risk to public health, the DOA or FDA cannot legally enforce a recall. Further, the product should be quantified to determine the level of pathogen in it. If the amount of pathogen found in the product does not meet infective dose criteria it also cannot be classified as a risk to the public and enforcement is not legal.
- Enforcement – FDA is required, once a positive sample is indicated, to ask a manufacturer what they are going to improve their practices so it doesn’t happen again. These improvements must be incorporated into their FSMA (Food Safety Modernization Act) required HACCP (Hazard Analysis and Critical Control Point) plan. There are no requirements for a company to implement any specific practice to achieve quality control improvements. Most manufacturers wrongly believe that their only options at this point are to improve cleanliness at their facilities (which in some cases seems impossible as cleanliness is the highest priority), cook, or HPP. There is no sterilization method in existence that is 100% effective at eliminating pathogens and preventing recontamination. There are many potential options for sterilization including Essential Oils, Ozone, Fermentation or Cultures, Phages, and more. Even cooking and irradiation, which are approved sterilization methods, are not 100% effective, as required by the Zero Tolerance Policy. As a matter of fact, well-known studies show that low-moisture (kibble) products must be cooked at high temperatures for several hours to eliminate pathogens (most are cooked at 225* for a few minutes) while high-moisture products (raw) only need to be heated for 5 minutes at 140* to eliminate pathogens.
- Summary – Even products that are cleanly sourced and sterilized cannot comply with an unrealistic Zero Tolerance Policy. This is because “zero tolerance” includes serovars that don’t and can’t cause illness, in levels that don’t and can’t cause illness, and serovars that are yet to be discovered, thus making the policy unattainable. Though the law requires FDA or DOA to prove public health risk before attempting enforcement, this is never done because they are able to default to the conflicting “Zero Tolerance” policy, which is not legally enforceable.
*Why is poultry the most likely to test positive for pathogens?
While pet food is under the jurisdiction of FDA, meat and poultry are under the jurisdiction of USDA. A quality raw food company will not purchase low-quality Rendered meats, and instead will purchase the same quality meats that you and I would eat (USDA). USDA allows meat processors the opportunity to label their meat as NRTE, or Not Ready To Eat, which allows for some pathogens as they will be cooked out in your home. However, when a raw food company purchases this same meat the FDA says, “raw pet foods can have absolutely no pathogens, no matter what the quality of sourcing is.” Poultry innately harbors more pathogenic bacteria.
A 2010 meeting of global leaders on pathogen control met with US regulators to establish an improved model of pathogen control. All of these leaders stated that the FDA Zero Tolerance Policy is unattainable. Sweden achieves a pathogen free population by testing and holding flocks of birds until pathogen problems resolve before allowing them to go to slaughter. Despite advisements such as these, and their proven efficacy, US Regulators chose to continue previous practices which do not include pathogen control of flocks and instead seek out pathogens far past the source… at the retail level.
What is the actual risk of pathogenic exposure from recalled raw products?
- FDA recall statistics show that commercially available fully raw products are 64 times less likely to experience a recall than kibble, while HPP frozen foods are 1.5 times more likely to experience a recall.
- CDC Salmonella tracking shows that of the 2,500+ identified serovars, only 1,023 have ever been found in humans… which means that over 1,477 have not. Of those 1,023 only 47 of them have been shown to even have mild regularity in human populations. CDC prioritizes only 10 of them.
- FDA regularly references a scientific study where populations of dogs were fed chicken products that were intentionally contaminated with various Salmonella serovars. FDA stresses that this study showed that 44% of dogs that eat raw food shed Salmonella in their feces. What they do NOT mention is that 100% of the meat was intentionally infected with Salmonella and 56%, the majority, of dogs that consumed it did NOT shed Salmonella in their feces. FDA also fails to mention that not a single dog in the study ever got sick from the exposure, and that they were not able to make the link between the serovars that were fed and those that were shed.
- Further, a study done on canine populations tested fecal samples of over 8,000 dogs, fed all diets including kibble, and 27.6% came back positive for Salmonella, evidencing that feces harbors pathogens in some cases, no matter the diet you feed your pet.
Ramifications of a recall –
- Consumers – Most consumers never really know about recalls. A very small percentage follow blogs that notify them, but in many cases, product is intercepted prior to their exposure to it. On the occasion that a pet parent does learn about a recall, they will generally not consistently stop using it because they have had good experiences with the line or they wouldn’t be using it.
- Retailers – Retailers should get recall notifications from distributors. This is inconsistently done. Notification is also dependent on the retailer or their staff checking their email in a timely fashion and sharing the information with other staff. If this process goes right, the retailer is responsible for returning remaining product and getting credit from the distributor. In most cases, though, recall efforts occur months after production and there is little to no product remaining to remove from shelves. Further, there has never been a confirmed case of illness or death associated with a recall of a raw or hpp frozen commercially available pet food. Therefore, the products tend to of already been consumed by pets, without problems, prior to the recall.
- Distributors – Distributors are notified by manufacturers and are responsible for notifying/crediting retailers and receiving reimbursement by manufacturers. The level of responsibility a distributor has in this process is paramount to the success of the company. The distributor has the ability to get the manufacturer in trouble for not notifying the public. They also have the ability to cause severe financial trauma to the company if they are unethical and ask for credits in excess of need. Further, if they are uneducated about the circumstances of the recall, they can cause financial trauma to the company by not placing or paying for previous orders. This can unnecessarily cost the manufacturer tens to hundreds of thousands of dollars, making it impossible for them to recover from an otherwise minimally damaging recall.
What does this look like for Manufacturers? A poll of raw food manufacturers shows that there is generally very little damage done to a company by recalling. Is that really true, though, if we extend the timeline from the acute recall to the years that a company is in business?
What is the impact of recalling? Remember that if the FDA is not capable of proving that there is a public health risk, they cannot enforce a recall which is why there has never been a mandatory recall on raw foods…. Lack of evidence. FDA pressure placed on manufacturers feels scary, like they may lose the company that is their and their family’s livelihood. Acutely, recalling gets the FDA to back off. FDA looks better to Congress when they can present evidence of work they’ve done (by pressuring the easy target of low-income ethical companies over big industry that have the funds to legally battle these pressures).
The problem with recalling without evidence of need, is that it sets a precedence with FDA. It shows FDA that small manufacturers are easy targets due to lack of resources, as compared to larger targets with pocketbooks and legal teams ((Mars (Salmonella lawsuits), Nestle (foreign body lawsuits), Del Monte (pentobarbital lawsuits), Kelloggs (Salmonella lawsuits), etc.)) When you make yourself and easy target you’ll find yourself surrounded by people that are aiming at you.
What if a company does not recall? FDA feels secure in its stance on pathogens and recalls. Rightfully so because thus far their illegal enforcement has not be questioned in a way that burdens them. If a company chooses not to recall they will almost unquestionably have to endure the burden and expense of a lawsuit against the FDA or DOA that sampled their products. This costly venture would most assuredly exceed the cost of a single recall. However, it would not exceed the cost of multiple recalls that would occur because the unobtainable Zero Tolerance that created the recall in the first place was never altered. And it would not exceed the cost of losing their entire company after trying repeatedly to adhere to the Zero Tolerance Policy, to no avail, and are then given legitimate reason to go out of business by proving they are incapable of compliance. Long term, the only resolution that raw food manufacturers and processors have to ensure survival is to fight the Zero Tolerance Policy to make it something attainable and realistic, while still making products safe for the industry. This can only be done through legal avenues.
This fight is already in play but most manufacturers are too afraid to jump on board. They fear having a target on their back, as if they don’t already have one. They fear consumers misunderstanding their cause and viewing them as rogue and dangerous companies. They fear the expense of a lawsuit. They do not see the long term value of fighting and instead accept the short term and more damaging gain of recalling. The public, however, can assist by showing support to these companies, educating consumers, and talking to manufacturers about how their success is your success.
Why does this matter to Retailers?
Retailers drive the direction and success of the market. If a retailer does not provide products to consumers, they don’t know to or can’t buy them, and manufacturers cannot survive without a consumer outlet. Therefore, it is imperative for retailers to understand what goes on behind the scenes in the industry so they can make choices on behalf of the industry and consumers.
If retailers jump ship from fresh food products due to a misunderstanding of recall processes, they will perpetuate the continuation of processed foods on the market and elimination of fresh food options. What does this look like in the big picture? Processed foods, like for people, are proven to contribute to increased instances of diabetes, cancer, digestive disorders and allergies. Further, processed foods source their materials from biodiesel, oleochemical and rendering scraps. The more processed foods that retailers promote, the more support these industries have in selling their trash. The more fresh foods that retailers promote, the more support there is for ethical farmers and cleaner, more eco-conscious production from farm to table.
Further, fresh foods are more profitable for retailers. (A 50lb dog eating a $75 bag of kibble will make a retailer $45/mo ($11 profit) while the same dog eating a raw food that costs $40 for 6lbs will make a retailer $150/mo ($37 profit… 3 times more than kibble AND it’s healthier and safer))
How can you help out?
Support fresh food companies. If you don’t know whether or not a recall is valid vs the result of FDA or distributor bullying, call the company and ask. If you’re not sure if you can trust the company to answer honestly, ask Susan Thixton with https://truthaboutpetfood.com/, or Chelsea Kent with https://FoodRegulationFacts.com, or Cathy Alinovi with http://www.ngpfma.org/
Educate consumers about the sampling and testing protocol, Zero Tolerance Policy, and the current plight of fresh foods against FDA and the industries that are rooting for kibble – without huge kibble sales the biodiesel, oleochemical and rendering industries are less profitable. Pressure on fresh food is not about keeping products safe for consumers and their pets… it’s about keeping big industry financially supported.
Share your support with manufacturers. Direct them to join NGPFMA (listed above) and tell them you support them in their plight.
Note from the Author – I did not put references on this document because they are better served in additional documents or direct conversation. If you have questions about anything in this document, would like references or need clarity, please contact FoodRegulationFacts@gmail.com