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My Senate Testimony RE: 2023 Budget Request By FDA-CVM For Additional $48 Million

April 12, 2022

To: United States Senate Committee On Appropriations 

Re: the U.S. Food and Drug Administration's fiscal year 2023 budget

(the following was submitted to, and was cc'd.)

Daily, I am attempting to be a proactive citizen and exercise the right all Americans are told we should be proud of...which include our being a government "by the people". While I don't disagree that democracy is "messy", what democracy shouldn't be is government against the people. In my experience over the years, that is what I have faced. I and what appears to be many others, are still facing FDA-CVM battle against us in completely unnecessary ways. I wish to testify about this regarding FDA asking for billions in their new budget. 

FDA-Center for Veterinary Medicine (FDA-CVM) holds no regular public meetings when it comes to promulgating regulations for the pet food industry. FDA-CVM instead "sits on the board" of a private corporation called AAFCO. Along with state partners FDA-CVM provides millions in funding to, FDA-CVM employees help create regulations in private, via private meetings. Then through a "memorandum of understanding", FDA-CVM "recognizes" AAFCO's privately developed ingredients federally. By doing this, FDA-CVM is attempting to bypass requirements of the federal Administrative Procedures Act law. We citizens do not get to comment. publicly on these ingredients and their definitions, even though FDA-CVM fully intends these ingredients to be "regulations" federally. We also do not get to attend meetings where FDA and other public regulatory partners develop these ingredients unless we pay the "private corporation" run by public employees. Most disturbingly, the "private corporation" run by public employees is copyrighting these terms, which are adopted by state laws as "regulations" and "recognized" federally as regulations as well. 

The US Senate, you who are hearing my testimony today, are allowing for such corruption and secrecy in government, if you continue to provide tens of millions of dollars in additional funding to FDA-CVM, as they continue to cut out citizens from the federal regulatory process. 

Since the overall issue of animal feed/pet food regulations deal with products in interstate commerce, FDA-CVM regulatory jurisdiction, FDA-CVM should be heading up these public meetings and promulgating the regulations publicly. They refuse to do so. FDA-CVM has even stated citizens have to obtain the regulations by purchasing them directly from this "private corporation". Yes, "regulations" FDA-CVM employees helped create while acting in their official positions, being paid federally. FDA-CVM also reviews "all science" of all AAFCO "regulations" prior to AAFCO finalizing the animal feed/pet food definitions. Then, they're copyrighted. It is beyond uncalled for.

FDA-CVM and state regulatory partners (who FDA-CVM provides millions in grant money to), proudly tout that "regulations", or model regulations, or whatever is happening here privately, are based on "science". Well, when science is requested from AAFCO (the private corporation FDA helps operate), AAFCO responds they don't have the records. FDA-CVM states they'll respond to FOIA requests within 18-24 months, if not more amounts of time. Some requestors are facing 3+ years of waiting time to receive records. In most cases so far, even FDA-CVM doesn't have scientific records for these ingredients they supposedly performed a scientific review on! 

FDA-CVM employee Steven Solomon touted in a 2022 "virtual listening session" on pet food regulation, that "the review of ingredients themselves continues to be a priority for the center. Congress recently gave CVM some additional resources to increase our staffing levels. With additional staff members, we've reduced the time it takes to complete our ingredient review and we hope to continue that trend in the future." 

I ask you, and I ask congress, why is FDA-CVM allowing federally funded work to be copyrighted by others? Why is FDA-CVM holding only one, virtual listening session and not actual regular, public meetings to promulgate regulations? Why is congress providing CVM additional resources to continue what essentially is the privatization of the regulatory process? Is it because congress is unaware that FDA-CVM is conducting such work in private? Is it because congress doesn't care, because part of this is "pet food"? I just don't understand why federal money is being used to benefit this privatized process. FDA-CVM won't dare hold public Q&A meetings, where they respond to citizen questions live. They're too afraid they'll have to be honest, and the public will see their battle against citizens for what it is. 

I wish to participate in the regulatory process, from the federal standpoint, in compliance with the federal administrative procedures act. I submitted an FDA citizen petition on this matter. According to regulations, FDA has 180 days to respond to my petition. They have not provided a final response to my petition, and it's been since May 6, 2021. I don't want to sue the agency to force a response. I find it fascinating that they agency can't respond within 180 regarding the legality of their participating in private AAFCO meetings to create "regulations", which they "recognize federally", and my petition asked them to instead promulgate the regulations publicly. Somehow, the FDA-CVM can't provide a response to that simple request since March 6, 2021. 

Some aspects of FDA agency work is difficult. I get it. It's difficult to do what FDA is tasked to do. I don't believe it is difficult to include citizens though. I'm being cut out. Congress is essentially saying, I do not matter as a citizen. FDA is saying I don't get to participate in helping promulgate regulations, which the Administrative Procedures Act affords me. 

I write this and end with a call to require FDA, specifically FDA-CVM, to mandate more employees to the FOIA offices of FDA-CVM. In taking 18-24 or 3+ more years to respond to simple requests for records, FDA-CVM is being provided a massive upper hand against citizens. Citizens like me are burdened by their agency's lack of regulation, and lack of ability to follow basic law. 

Additionally, providing FDA-CVM with tens of millions of dollars in additional funds while the agency doesn't even hold regular, public meetings to promulgate regulations, is uncalled for. 

FDA-CVM stated they do not have the "resources" to hold such meetings, yet they have made no effort to solidify the latest resources in their latest budget request for additional funds. They simply do not want to hold public meetings. They want to continue their business with little citizen interaction as possible. I ask you to please help us in the public when it comes to regular, public regulatory meetings the agency should have been holding for decades already. 

Transparency matters. Access to records in a timelier fashion is important. Otherwise, we're continuing to be left in the dust as citizens. 

-Kohl Harrington


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