Today on December 29, 2020, I called Charlotte Conway of FDA-CVM to discuss several issues currently happening in the "regulatory" sector of the pet food industry, specifically at the FDA. Ms. Conway has regularly attended private AAFCO meetings, where public employees are performing regulatory functions in private. She is currently the deputy director of the FDA-CVM
Public records show Ms. Conway is also one of the FDA employees who has been "regulating" by what they state is their "opinion" instead of a properly passed rule.
As part of ongoing Pet Schooled research, I have been trying to obtain an actual regulation for the use of the term "raw" for use on pet food packages. No one at the FDA has been willing to provide me that very simple regulation, or confirm with me that it doesn't exist. Some of my efforts to verify the existence of this regulation has included a phone call to Dan Danielson of FDA on December 10, 2020. Mr. Danielson hung up on me during this conversation, and my follow up attempts via email didn't result in Mr. Danielson providing me with the regulation for the use of the term "raw" on pet food packages.
A phone call was also placed to Mika Alewynse of FDA, who confirmed there was an official regulation for the term "raw agricultural commodity" listed in the federal register. When I informed Ms. Alewynse that this was not a specific regulation for the use of the term "raw" on pet food packages and inquired if one actually existed,
I have also attempted to receive this regulation from Dr. William Burkholder of FDA. Several calls, voice messages, and emails were placed to Mr. Burkholder. I have not received any response.
Even the FDA media department refused to provide me with an actual FDA regulation for the term "raw", for use on pet food packages.
My initial conversation with Mr. Danielson resulted in him initially trying to reference me to the "AAFCO" definition for the term raw. When I informed him that I wasn't calling about AAFCO, I was calling about trying to get the actual FDA regulation, this is when Mr. Danielson became quite combative and eventually hung up the phone.
When Ms. Conway answered her phone today, I asked her specifically "I'm trying to get in touch with someone at the FDA about getting the official FDA regulation for the use of the term 'raw' on pet food packages."
The following is a memorialization of my phone conversation with Ms. Conway.
Kohl: "I'm not able to find a regulation, and I'm trying to see if someone at FDA would have it."
Charlotte Conway FDA: "Who is calling?"
Kohl: "My name is Kohl."
Charlotte Conway FDA: "Kohl?"
Kohl: "Would you know of there being an actual FDA regulation for the term raw, for use on pet food packages? I don't know of there being one."
Charlotte Conway FDA: "I can have someone call you back."
Kohl: "I'm actually only looking to confirm if you have that information."
Charlotte Conway FDA: "I'm not actually able to provide that at this time."
Charlotte Conway FDA: "I've been asked to."
Kohl: "Are you aware of there being an actual FDA regulation or definition for raw? I know you go to AAFCO. I understand you participate in helping operate AAFCO to a degree. I understand AAFCO may have a definition. I'm trying to confirm if FDA has an actual regulation, or do you guys amend to the AAFCO definition?"
Charlotte Conway FDA: "I'm not able to provide any further information to you."
Kohl: "I'm sorry, I don't understand the extreme steps FDA continues to take to not provide information to citizens. Why aren't you able to help citizens understand basic information, and help get a regulation? That's the big confusion. You guys are shutting down constantly, instead of helping us citizens understand really basic information."
Kohl: "This is such a simple issue. It doesn't call for you guys to shut down like this and refuse to help. Again, FDA regulation for the use of the term raw on animal feed packages, and pet food packages. It's your department."
Charlotte Conway FDA: "We'll respond in writing."
Kohl: "Ok. Why don't you guys have public meetings for pet food regulations to be adopted. You guys are doing all of this privately at AAFCO. Why not hold meetings publicly?"
Charlotte Conway FDA: "You've been asked to submit questions to..."
Kohl: "I'm asking you, the deputy director. You guys won't have public meetings so we as citizens can ask you questions. You guys basically shut us down. Why no public meetings?"
Charlotte Conway FDA: "I don't have an answer for that question."
Kohl: "Is it not a concern to you that so much stuff is being done in private? Instead of you guys performing regulatory meetings publicly, and adhering to the administrative procedures act?"
Charlotte Conway FDA: "I'm not a lawyer, so I could not answer that question."
Kohl: "Why are you guys regulating by your opinion? This is in regards to your zero tolerance compliance policy opinion, which is not an actual law or regulation. It's your opinion and I confirmed that information with congress. Why not pass that as an actual regulation? You guys are regulating by your opinion."
Charlotte Conway FDA: "I'm going to leave this conversation at this time."
Kohl: "Why not be transparent Ms. Conway? Why not help citizens? I don't understand the severe lack of transparency from you guys at FDA on simple matters. Why do you have to leave the conversation vs. answer questions and justify your actions, further helping citizens understand why you're doing what you're doing at FDA? You're regulating by your opinion, and you hold no public meetings so we citizens can attend and be involved. You are doing it all privately."
Charlotte Conway FDA: "There's nothing else I can do for you."