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Pissy Email From FDA-CVM Simply More Evidence Of Agency's Ongoing Anti-Citizen & Anti Democracy Campaigns

It seems like many more citizens other than myself are now experiencing first hand, what I've been reporting on for more than 10 years now. A federal agency, FDA-CVM (Center For Veterinary Medicine), ill equipped to actually regulate, leading to a highly unregulated pet food industry. On top of that, years long FOIA delays, FDA-CVM employees engages in promulgating regulations in private, FDA-CVM employees regulating by "opinion" instead of law, while refusing to enforce federal law when it comes to many circumstances surrounding big dry pet food. Most disturbingly, FDA-CVM employees telling citizens their only opportunity to engage in rule making is to petition the government by filing citizen petitions, then the agency's failure to provide final answers on citizen petitions, and additional refusals to commit to a date in which the agency will be providing a final response. 

FDA-CVM's latest email to me on March 16, 2022 from their anonymous ASK CVM email address appears to be even more evidence of the agency's continued fight against the democratic process. In citizen petition FDA-2021-P-0436, I have requested that "FDA’s Center for Veterinary Medicine (CVM) withdraw MOU 225-07-7001 and develop animal feed terms and definitions publicly and in compliance with the Administrative Procedure Act."  A simple request asking federal public employees to please stop their unlawful and undemocratic process of making "regulations" in private. 

The agency failed to provide me a final response within the legally required 180 days. As I write this today, it is now March 17, 2022. FDA-CVM provided me a "tentative response" back on October 28, 2021, essentially stating they were "responding" before the 180 days, but had no final response. My question was simple. "When is the estimated completion date for this?" When can I actually expect the agency to respond? I asked that question on October 28, 2021. The agency didn't respond. I asked again on November 1, 2021. Again, no response. So, I asked again on January 10, 2022. No response. Then again on March 10, 2022. After asking 4 times over the course of nearly 5 months, FDA-CVM sent a reply on March 16, 2022 stating, "We understand that you are interested in receiving a final response to your petition as soon as possible. We share your interest in that regard. As we’ve indicated previously, we are working diligently through the legal and policy considerations related to your request."  

I find it disturbing how FDA-CVM has no legal response to provide me concerning their involvement with the private corporation AAFCO. Public regulators should be promulgating regulations via public meetings. Given that the entire purpose of AAFCO is for products in interstate commerce which fall under FDA regulatory jurisdiction, FDA-CVM should be hosting these public meetings. Instead, the agency concocted a "memorandum of understanding" with the private corporation AAFCO. AAFCO is simply a collection of federal and state public regulators, all acting privately with a main effort to escape public rule making requirements. In my research, I have spoken with various public "regulators" who have no idea what "public rule making" is, nor do they seem concerned that AAFCO is charging citizens to engage in what becomes law at the federal level. 

In response to my questions on when I'll receive a final response, FDA-CVM refused to provide an estimated date on which I can expect to receive their final response. "At this time, we cannot estimate a date by which we will provide a final response to your petition."  The agency goes on to state, "Often, the same CVM professional staff required to respond to petitions are responsible for other substantive public health regulatory work, including surveillance and compliance activities. Although we take action to respond to citizen petitions in as timely a fashion as possible, realities such as the need for extensive discussions about policy or legal issues, the existence of other agency public health regulatory priorities, or the need for additional information may extend the time to respond."

Would you expect "policy or legal issues" to have been discussed extensively, prior to the agency engaging in a "memorandum of understanding" with the private corporation? I've come to learn not to expect FDA-CVM employees to be the most lawful when it comes to what they "want to do." I've seen time and time again when various FDA-CVM employees want to do something, they literally do not appear care if it's lawful or not. 

In FDA-CVM's email to me yesterday, they seem to be whining about the uptick in citizens engaging with the agency, after what appears to be years of the agency refusing to hold public meetings, or engage in proper rule making on a variety of issues. FDA-CVM states, "we are experiencing an unprecedented increase in new citizen petitions. CVM’s active petition inventory has grown from ten active petitions at this time two years ago to 71 active petitions today." I don't see what the big issue there. The USA is a democracy, and a country of over 350 million people. By saying "unprecedented", is FDA-CVM trying to set up a future where they stop responding to citizen petitions? So, there will be an agency refusing to file FOIA requests in accordance with law, refusing to hold public meetings, refusing to enforce federal law on a variety of issues, refusing to promulgate regulations on a variety of issues, refusing to stop regulating by their opinion, and on top of all of that, FDA-CVM refusing to provided responses to citizen petitions? That's quite a list of serious issues. 

Democracy is tough and rough. It's not for the weak. FDA-CVM employees have gotten away with too much for too long. It's impressive to see an uptick in citizen proactiveness, and I truly hope it continues for years to come. For those wishing to read the entire email provided to me today, I've pasted it below. 

All the best,

Kohl Harrington

------------------

March 16, 2022

Dear Mr. Harrington,

This responds to your multiple emails to AskCVM, requesting an estimated date for a final response to your citizen petition, FDA-2021-P-0436.  The petition requests that FDA’s Center for Veterinary Medicine (CVM) withdraw MOU 225-07-7001 and develop animal feed terms and definitions publicly and in compliance with the Administrative Procedure Act.  You also repeatedly asked why you have been asked to direct inquiries to the AskCVM mailbox.

We understand that you are interested in receiving a final response to your petition as soon as possible.  We share your interest in that regard.  As we’ve indicated previously, we are working diligently through the legal and policy considerations related to your request.  Because we were not able to complete that work and issue our final response within 180 days of receiving your petition, we issued our tentative response on October 28, 2021, in accordance with the requirements set forth in 21 CFR 10.30.  

At this time, we cannot estimate a date by which we will provide a final response to your petition.  Often, the same CVM professional staff required to respond to petitions are responsible for other substantive public health regulatory work, including surveillance and compliance activities. Although we take action to respond to citizen petitions in as timely a fashion as possible, realities such as the need for extensive discussions about policy or legal issues, the existence of other agency public health regulatory priorities, or the need for additional information may extend the time to respond.

In addition, we are experiencing an unprecedented increase in new citizen petitions.[1] CVM’s active petition inventory has grown from ten active petitions at this time two years ago to 71 active petitions today.  That sevenfold increase occurred despite the fact that we issued final responses to 10 petitions in 2021, including three final responses issued to citizen petitions submitted by your company, Pet Schooled.  While we fully support your right to petition us, we note that 22 of our active petitions (32 percent of our inventory) are from Pet Schooled.  In addition, we currently have 13 other active petitions requesting virtually the same actions as you have requested in your citizen petition, FDA-2021-P-0436.

We will continue to provide final responses to your petitions as quickly as reasonably possible.  Please understand that response times may be affected by, among other things, the vastly increased volume of petitions CVM is receiving, the limited resources available to us for considering and responding to petitions, including the need to pull subject-matter experts away from their other public health regulatory responsibilities to work on the responses, and the time needed for robust internal policy and legal discussions to determine the appropriate responses to the petitions.

Regarding your question about why CVM directs inquiries to the AskCVM mailbox, CVM requests that stakeholders use that mailbox so that inquiries can be properly logged in, tracked, and forwarded to the appropriate parties for response, and that CVM’s responses can be documented. Although we have repeatedly asked that you send inquires to AskCVM, you continue to email and call CVM employees directly.  Again, directly contacting CVM employees bypasses the systems in place to ensure questions are properly received and answered, and diverts resources from other substantive work, including working on responses to your many inquiries, petitions, and requests.  We again request that you to use the AskCVM mailbox to submit questions to CVM.

 

Sincerely,

AskCVM



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