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FOIA Request Reveals Severe Lack Of FDA-CVM Records On HPP

Years ago, I had a back and forth with FDA where the media department refused to specific whether "raw" pet food that had been subjected to HPP (high pressure pasteurization) had been subjected to a kill step or not. The FDA stated "HPP can be a kill step when effectively done, however, it must be properly validated to confirm the effectiveness in a pet food product. "

I then asked FDA:

  • Please define or provide me documents on "when effectively done" means as per FDA. 
  • What does FDA deem to be properly validated to confirm the effectiveness in a pet food product?
  • Does FDA approve a pet food company's use as HPP as effective or non effective before they implement this in their foods?
After FDA-CVM refused to provide me further information, I filed a FOIA request with the agency for records on this matter. I eventually had to sue the agency under FOIA law, and force the agency to comply with my FOIA request. Years later, I finally have what FDA-CVM is stating is their "final" response to the FOIA request, and the records the agency has on the matter of HPP and raw pet food is shockingly small. The agency provided only 25 pages of records, yet they withheld 23 pages in full under FOIA redactions (b)(4) and (b)(5). 

The issue surrounding pet food products labeled as "raw" which have gone through HPP, is that USDA actually considers these types of products to be pasteurized. Why then is FDA-CVM allowing for such products to be labeled as "raw"? When a citizen is purchasing a product labeled as "raw" when in reality it has been subjected to a pasteurization technique, is that fraud? 

On October 12, 2021, I submitted a citizen petition to FDA-CVM asking for the agency to issue a regulation for the term "raw". The agency is suppose to respond to citizen petitions within 180 days. However on April 11, 2022, FDA-CVM stated they will "require additional time to issue a final response" on this matter. It appears as though HPP for raw pet food is yet one more area where FDA-CVM is not regularly engaged in regulating. 

Additionally, more than three citizens have requested the same HPP records that I requested from FDA-CVM. FOIA law requires agencies like FDA-CVM to publicly post records that have been requested from the agency 3+ times. Regulations.gov, the where citizens can petition FDA-CVM to take action on issues, shows that FDA-CVM has been petitioned at least three times to post their lackluster HPP "records" on the agency's public FOIA reading room. I petitioned FDA-CVM on this transparency issue on January 8, 2022. So far, the agency has not responded, stating that they will comply with FOIA law in relation to these HPP records. 

I have to wonder, is this why the agency was so against answering my questions in the first place? Did they not have the information in order to properly answer simple questions on a topic they're suppose to be regulating? Also, what is FDA-CVM going to do moving forward on this matter? Are they going to try to do everything possible to avoid the regulatory process on this matter, as they're doing in other areas? Even FDA-CVM's own science doesn't support HPP as "raw", and it will be interesting to see how hard FDA-CVM employees respond to this ongoing issue. 

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