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Temperature abuse of raw food samples used for regulatory action is condoned by regulatory agencies and FDA

October 8, 2018

Update  10/20/18:  We've been asked by countless people to set up a Go Fund Me account to help re-boot the company, so we have done that.  Please see https://www.gofundme.com/how-to-help-rad-cat-after-closure

 

Hello all Rad readers!  It's been a mighty long time since I've posted anything here, but this is a very important subject for all raw feeders and for other raw manufacturers.  Pretty much everyone in the pet industry knows there has been extraordinary scrutiny of us raw food manufacturers by the FDA.  It's also very common knowledge in the industry that the FDA and other regulatory agencies will take extreme measures to put pressure on manufacturers, which includes measures that are, in fact, unethical and sometimes conflict with the law.

 

As everyone knows, we have had a very large recall and our products have been scarce lately and we're very sorry.  This is Part One of two blogs that we will post here that tells the story behind this recall and why there's little Rad Cat on the market.  

 

Some people will say that these posts are brave and others will think that we're nuts for posting such blatant truth about the Colorado Department of Agriculture and the FDA.  This is information that needs to be published and people need to know what is happening.  Regulatory agencies are operating unchecked and are self-governed, which gives them ultimate authority to do whatever they please, which is wrong.  

 

Please read on to learn about how the Colorado Department of Agriculture allows mishandling and temperature abuse of raw food samples that are used to take regulatory action and is completely condoned by the FDA.

 

The following is a synopsis of the intentional mishandling and processing of a sample of Pasture-Raised Venison that was collected by the Colorado Department of Agriculture and used by the FDA to take regulatory action.  Why is this so important?  State Depts. of Agriculture are enlisted by the FDA to sample raw pet food to test for pathogens at their labs.  These results are then used by the FDA to take regulatory action, such as pressuring or forcing raw food companies into recalling product.  This temperature abused and mishandled sample that was collected by the Colorado Department of Agriculture should never have been deemed valid for testing - in fact the sample should have been discarded when it arrived at the lab due to temperature abuse.  Other regulatory agencies, such as the USDA, would not and should not test samples that have been mishandled.  The FDA is supposed to observe this, as well.  The CO Dept. of Agriculture actually (after several phone calls and much argument) "retracted" their Notice of Alleged Violation and are not pursuing regulatory action in Colorado related to this sample because of the abusive circumstances surrounding it.  However, the FDA chose to use it against us anyway, which caused us to issue the largest recall the raw food community has ever seen.

 

In July, the CO Dept. of Agriculture sent us a letter stating that they sampled one container of our venison on April 11, 2018, had it tested in July and that it was positive for Listeria monocytogenes.  Well, this lot of venison even didn’t ship until May, so we knew this was not true.  And, even if it were, what in the world happened to the sample during the three months they had it?

 

When they were confronted with this issue, they said ‘Oops, this was a mistake (on a legal document) and we’ll re-issue the letter with the correct date of sampling’.  They made the correction and sent us a new letter.  This is the first in a long line of 'mistakes' that were made by Colorado.

 

We asked them for all supporting documents: purchase receipts, field notes, SOPs (Standard Operating Procedure) for transportation of our sample, lab work papers, and the split sample from the lab.  For those that may not know what a ‘split sample’ is:  it is a portion of the very same sample that was collected and tested by the lab.  In most states, manufacturers have a right to these to verify that it is, in fact, their product, as well as test it to verify results that were reported to them.  Another Dept. of Ag., The Ohio Dept. of Agriculture, sampled and tested our products twice in the past – when we asked for a split sample, they refused to provide us with one which, in that state, we have now learned that refusal is actually a violation of Federal Law…  but I digress…

 

We did receive everything, including our split sample, and found a mountain of inconsistencies, including faulty work papers and misstatements. This sample should have never even been tested because it was received at the lab temperature abused and thawed.  Here are the basic issues with this sample:

 

  • The inspector purchased our sample at a retail store, set the container in the front seat of his hot car in July ‘in front of the air conditioner’, where it sat until it arrived at the lab, hours later. He even had a cooler in his car and chose not to use it.
  • It arrived at the lab thawed. The lab did not take a temperature reading of the sample – they just go by ‘well, it felt cold to the touch, but it must have been partially frozen’.  Things that are 60 degrees can feel ‘cold’ to the touch.  This sample was obviously temperature abused and they tested it anyway.  Samples are supposed to be kept in the form they were purchased – in this case frozen.  They did not do this and it never should have been tested.
  • The CO Dept. of Ag. does not have an SOP for the sampling and transport of samples.
  • The CO Dept. of Ag. does not take temperature readings of frozen or refrigerated samples when they arrive at their lab. Their procedure actually prohibits them from taking temperature readings.
  • We had the split sample tested at our independent third party lab and it tested negative (this is the exact same sample they tested, shipped to us from the Colorado Dept. of Ag. lab)
  • Most of the working papers don’t even tie to our sample
  • We have one paper that says our sample tested positive, and one that says it tested negative
  • The deputy lab manager acknowledged on more than one occasion that she made assumptions not based on fact, was given misinformation and her subordinates did not follow SOPs.

We have all of this information on record, from multiple conversations with the CO Dept. of Ag.  The CO Dept. of Agriculture abused our sample and tested it anyway and it was used by the FDA to take regulatory action against us.  We also have them on record saying the FDA knew of the issues with this sample and chose to accept their positive results regardless of how the sample was handled.  What does this mean?  It means the FDA knowingly acknowledges and accepts the results of temperature abused samples to take regulatory action against raw pet food companies. If a pathogen is found in a temperature abused and mishandled sample, it is still considered actionable by the FDA.   The FDA states in their own sampling procedures that samples are to be kept in the same manner in which they are purchased and they are required to be delivered to the laboratory in the same state.  Samples also need to be transported in a way that protects the integrity of the samples.  This did not happen here and the FDA completely condoned it, even though their own SOP's specify that this kind of mishandling is not appropriate for sample transport.

 

As a result of the gross mishandling of our sample, the Colorado Dept. of Ag. decided to not use this sample for any regulatory action and the Notice of Alleged Violation was retracted.  The FDA acted upon this abused and mishandled sample.  They threatened to issue what they called an urgent  Public Health Notice against our company, full of untruths about our facility, unless we recalled over a years' worth of product.  The FDA had this notice written and ready to send to the media.  We chose to recall, rather than to have a Public Health Notice issued.

 

The FDA used the results of this sample to claim that the Listeria monocytogenes that Colorado 'found' in our venison container, matched the Listeria they found in other products we had recalled (in March) and that they have now proven the contamination is spread across proteins. According to the FDA, this meant that Rad Cat needed to recall everything in market.  We have never received proof that there was any Listeria "match" between samples.  We only know that our sample was temperature abused by the CO Dept. of Agriculture and that the FDA accepted their results anyway – even though our split sample tested negative.  The FDA said, "Well, a negative could still be a positive", which makes no sense.  

 

We did receive one document from the FDA trying to tie all of our ‘positive listeria samples together’ with Whole Genome Sequencing.  This Colorado sample isn’t labeled and another sample was listed incorrectly.  We have no proof that the Listeria match is even true – a letter with errors was supposed to be our proof.  We have asked for it and it was never provided to us.  The FDA will not be transparent with their results, methods or working papers.  We've been shown that the FDA considers using results of invalid samples as acceptable.  And that lab reports and legal documents that are full of errors and mis-labeled samples should be acceptable, as well.  

 

If these labs and State Departments of Agriculture don’t even have SOPs for sampling, transport or proper receiving of samples, they provide erroneous information and aren’t in control of what happens in their lab, raw pet food companies pay the price.  In our case, the FDA knew that this sample was invalid because the Colorado Dept. of Ag. told them about how this sample was handled and that it sat in the inspector's car in July, in the front seat, in a bag for hours before it got to the lab.  They chose to use the results from this sample, in addition to results from our other recalls to make us recall over a million pounds of food.  

  

I am writing this post to educate others about the many injustices that are being committed against raw food companies – not just Rad Cat.  There are other companies right now that are battling the Colorado Dept. of Agriculture and other State Depts. of Agriculture across the country that constantly mishandle samples.  Some will win those battles and some won’t.  When the FDA says they have enough evidence to force a recall or issue a Public Health Notice, chances are, they will do it – they’ve done it before.  Now, with the new FSMA rules in place, they are excited to perform their inspections. 

 

I hope what happened to us doesn’t happen to other companies, even though we are aware there are competitors of ours that are rejoicing in our recall and our products missing from shelves.  

 

This is about more than just us, at Rad Cat and it’s much bigger than us.  I’ve always advocated for everyone to put competition aside and band together, because there’s power in numbers, and if something is going to be done to push back against regulatory injustice, it’s going to need to be a group effort.  There’s plenty enough business for everyone.

 

 

 

 




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