I don’t have a background in science; I muddle through many scientific documents trying to comprehend them and reword the information as best I can into ‘everyday language’. When I received the FDA response to Spex CertiPrep’s testing of pet food, I saw that the FDA response seriously tried to discount the shocking pet food testing results. And I had a gut feeling there was something much more significant to this FDA response that I just didn’t understand.
It turns out that one of you out there – a Toxicologist AND a pet lover – saw right through the FDA response. She saw the real truth to this pet food testing results.
FDA’s Director of CVM Office of Surveillance and Compliance Dr. McChesney stated the following as significant reasoning for discounting the Spex CertiPrep pet food testing…
“The first mistake was the use of Environmental Protection Agency (EPA) Reference Dose and/or World Health Organization (WHO) Permissible Tolerable Daily Intake values … were indicative of safety concerns for the long term health of dogs or cats.” Dr. McChesney suggests that SpexCertiPrep should have used the National Research Council (NRC) ‘Mineral Tolerance of Animals Second Revised Edition 2005’. He goes on to say that the FDA uses this resource “to help determine whether concentrations of specific minerals in pet foods pose a threat for animal health and safety.” https://www.truthaboutpetfood.com/articles/cvm-finally-responds-to-pet-food-heavy-metal-results.html
In other words, the FDA did not agree with Spex CertiPrep using the heavy metal toxicity levels established by a partner U.S. government agency – the EPA. Instead, the FDA stated they follow heavy metal toxicity levels established by an independent organization – the NRC.
So what’s the problem? Turns out, the NRC’s toxicity levels of heavy metals in pet food aren’t nearly as comprehensive and risk based as the EPA’s. In other words, thanks to the NRC, pet food and animal food can get away with much higher levels of toxic heavy metals than if the FDA would follow the advise set by sister federal agency the EPA.
This is how our toxicologist friend Regina S. explained it to me…
“EPA references doses are based on actual toxicity studies. An EPA committee reviews the studies and not only determines a reference dose (RfD) which is the maximum dose at which no unacceptable health effects are expected, but also classifies the studies upon which these numbers were based (Low, Medium, High Confidence) and usually includes modifying and safety factors.”
“EPA’s committee that sets RfDs and SFs reviews the studies including the dosage, duration and conditions of the study as well as the results and interpretation of the results. From the best information available, they determine a NOAEL ( No Observed Adverse Effect Level) and to that they use modifying factors and uncertainty factors. These factors can be used if, for instance, you are using a subchronic NOAEL instead of a chronic NOAEL, you are extrapolating from a mouse to a human, you are accounting for a sensitive population, etc. For noncancer, the resulting number is called an RfD. The units are mg/Kg-day. So the RfD is the amount of chemical per kg of body weight that one can be exposed to on a daily basis and not have an unacceptable adverse health effect. In addition, EPA will include an assessment of their level of confidence in this RfD. If the study was not very well designed, but still useful, they may classify that as “Low”, If they have a very high quality study, they may classify that as “High”. If there are several studies which may not be ideal, but they get virtually the same result.. or there are several studies with different test subjects (rats, mice, dogs) but the same results, they could deem confidence in that RfD “Medium” to “High”.”
“From the summary of the NRC document, it appears that they simply reviewed the literature and came up with “tolerances” based on data in the literature. How many studies did they look at? I don’t know… you would probably have to look at each individual chemical. Did they review the original research and make some determination on whether the study was well designed? It does not appear that was part of their charge. The summary states that there were no modifying factors and they did not look at or take into account things such as bioavailability or other physical or chemical parameters.”
“Bottom line EPA reviews and evaluates the studies, calculates an RfD and provides a level of confidence in the results. The NRC report appears to have been a simple literature review.”
Remember, there are no FDA tolerance levels specific to pet food – all FDA food/feed tolerance levels are for all animal feed AND the FDA has no maximum level of many/most of the heavy metals found in pet food per the Spex CertiPrep testing (such as beryllium, uranium, cadmium, cobalt, chromium, caesium…).
For example, the FDA says that pet food/animal feed should have a maximum of 2 ppm (parts per million) of arsenic (or 2 mg/kg). Thanks to a brief toxicology calculations lesson provided by our Toxicologist Pet Friend – we know that a fifty pound dog consuming a pet food with 2 ppm of arsenic (the FDA’s allowance of arsenic) would be consuming a ‘dose’ of 0.04 mg/kg of arsenic per day in their pet food. But, according to the EPA’s in depth study of the risks of arsenic, a fifty pound dog can safely only consume 0.0003 mg/kg per day in their pet food.
This boils down to…the FDA allowing a level or arsenic in pet food/animal food 133 times GREATER than what the EPA believes is safe.
The FDA does nothing officially wrong or illegal by using NRC’s Mineral Tolerance of Animals. However, with the information our Toxicologist friend Regina brings to light, it does make you question how serious the FDA is at keeping pet food/animal food (and in turn human food) safe. Regina shared “If they were truly interested in protecting pet health to the highest level possible based on the best scientific information we have out there, the regulating Agency would have selected EPA’s numbers. However they opted for something they deemed “good enough” with the idea, I would guess, that if there were any questions, they could say, “Here is our source”.”
It’s no wonder FDA’s Dr. McChesney tried to squash Spex CertiPrep’s heavy metal testing of pet food; their pet food testing made the FDA look really inept at protecting our pets. And now with this added bit of information from Regina – we know that the FDA is at least 133 times as risky with our pets health than the EPA is. Really bad.
Wishing you and your pet(s) the best,
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