Public Comments Submitted by Kohl Harrington on April 7, 2022

My public comment concerns the FOIA process.

I will admit, from the very beginning, I had my doubts. It was years ago when an FDA FOIA (freedom of information act) employee asked me to have a "phone only" meeting with an "ombudsman" group called OGIS. The FDA FOIA employee Sarah Kotler stated that OGIS is "a neutral arbiter of FOIA related issues for government agencies and requesters".

This was in December 2018, and I had spend the greater part of the year documenting how FDA was regulating one sector of the pet food industry with their "opinion" they called a "compliance policy", while regulating the major dry pet food sector of the pet industry using "enforcement discretion", which translates into "looking the other way" as major violations of federal law occur. Part of what I had come across in my documenting was how the FDA would routinely get certain pet food manufacturers (who were not breaking the law) on the phone, threaten them, then potentially use the phone call against them in the future. With no written record, the company not breaking the law would be put in a very difficult position, with FDA demanding the company "voluntarily" recall the product or otherwise be subject to FDA releasing "warning letters" against the company. Only three or four companies so far have stood up to this potentially corrupt FDA action. As the years have gone by, I have been able to discover through FOIA (freedom of information act) how the very people within FDA-CVM behind this "regulation by opinion" have had questionable and seemingly regular communication with AFIA, the largest "grain" based lobbying group in the pet food industry. Turns out, the regulators who all operate the private group AAFCO have the same legal counsel as this major lobbying group, AFIA! 

The FDA is not one to normally "step up and do" what many of us would call "the right thing" in most occasions, so for this FDA FOIA employee to want to get on a phone with what she called a "neutral arbiter of FOIA", I assumed there must be more in it for her than there would be for me. 

I ended up telling that FOIA employee "you're welcome to send any information regarding what you want to discuss via email." 

She responded in a manner similar to how I've seen FDA operate with companies not breaking the law, "Does that mean you are not open to a call? That’s fine, I just want to make sure I am understanding you." Her goal here appeared to be to get me on record "refusing" to engage in mediation, of which I did not do. All she had to do was to send me information via email. She apparently didn't want that information on the written record. I had seen this same type of action with the FDA, where they appeared obsessed at times to say companies "refused" to provide a record, or provide information, in a potential effort to mark the company in as negative light as possible. Again, I have to question that connection to AFIA there. But with this FOIA communication, I was able to predict that this employee was probably trying to paint a potentially false picture and cry "you've refused!" 

Her excuse at the time was that mediation can not be done "via email when we are dealing with three entities" which became interesting years later when this same FDA FOIA employee, Sarah Kotler, refused mediation herself and OGIS proceeded to perform mediation tasks via email only...a complete contradiction. During this 2018 communication, Sarah Kotler of FDA FOIA went on what I would personally describe as a very unprofessional rant against me, sticking to her plot point that "at this point, you have refused a call." For years after this communication, she would always maintain I "refused" when I did not. In response to her very unprofessional communication, "As I previously stated, you and OGIS can indeed send anything you wish me to know via email. I will happily review it. If I can make your job easier, please let me know via email. Given your previous email making false allegations towards me, I am no longer comfortable speaking with you about this matter."

In theory, this OGIS "ombudsman" organization is suppose to listen to both sides, and try to help each side reach a resolution when it comes to matters of the freedom of information act. My experience with the organization has been anything but what OGIS "should" be. 

Over the years, I have requested OGIS mediation for various issues with several FOIA agencies, including FDA and CDC. In a two year span, I have asked OGIS on 10 separate occasions for a phone call to discuss various FOIA matters. Sometimes, OGIS would respond to my email inquiry requesting a call providing me information to other issues, and ignoring the phone call request. I would respond again asking for the phone call, but OGIS would maintain their silence on the phone call request. 

I started to feel like OGIS was more of an arm to protect FDA and other agencies, and it felt like OGIS was often taking the side of FDA in my FOIA matters. In theory, OGIS is not supposed to take a side. That struck me as interesting when the FDA demanded I "limit" the number of FOIA requests I've put in. When requesting OGIS mediation on a continuing FDA matter, OGIS said that unless I "limited the number of FOIA requests" I've put in, "there's nothing further" OGIS can do for me. No phone call offered to me to speak through this matter. No understanding my point of view. And...a very strong position taken. If I don't take FDA's demand, then I can't get any help from this so-called "neutral" organization? 

I suspected that behind the scenes, OGIS was probably speaking with FDA and other agencies about me, while essentially refusing to offer the same opportunity for me to speak to them. I wanted to know if that was true or not. So, I placed FOIA requests with OGIS directly concerning myself. When OGIS told me it would be 18-24 months before I received records, I called the FOIA officer to ask if there was anything I could do to receive the records sooner. The FOIA officer for OGIS went on her own rant, "do you NOT UNDERSTAND we have had budget cuts? The only way you can receive these faster is if you sue in federal court." 

Oh, dang. 

Luckily, I was able to receive the services of Loevy & Loevy, a brilliant FOIA firm in Chicago, Illinois. They took on my case and filed suit against OGIS in federal court. Loevy & Loevy also took on the lawsuits for my ongoing FDA issue, and they sued FDA on my behalf. The lawsuits forced both agencies to produce records. After about 9 months of suing OGIS, the records I wanted came through. 

Right before my eyes, in black and white, was a series of back and forth communication between this FDA FOIA employee Sarah Kotler, and OGIS employee Alina Semo. On March 10, 2020 Alina Semo of OGIS wrote HHS, FDA, and other members of OGIS stating, "I would like to ask that we all review and take stock and figure out a strategy going forward as soon as possible - and no later than March 29th! I had written to all of you earlier to ask if we could find some mutually-agreeable dates/times for a conf. call and did not hear back from everyone; now more than ever such a call is in order." Figure out a strategy going forward? And you're the so-called "neutral arbiter"? Doesn't sound too neutral to me when you're working with an agency breaking federal law to figure out a "strategy" to essentially use together against me. 

On March 23, 2020 Alina Semo (OGIS) provided more communication and information about me to FDA, HHS employees, and the FDA ombudsman group. Now, there were two ombudsman groups having meetings with the party I'm now litigation, discussing me.  On March 26, 2020, there was a "follow up conference call regarding Kohl Harrington FOIA requests/litigation" between Sarah and Alina. 

May 4, 2020, OGIS wrote me saying that FDA was open to mediation for requests not currently in litigation. They said FDA refused to participate via phone, and they would instead act as an intermediary. Again, interesting how the December 2018 claim of "phone only" has gone out the window. 

Again, it felt like the FDA and now with the help of OGIS, were both trying to put information on written records to use in potential future lawsuits against me. Yet, their communication to me still felt super vague. You're "now open to mediation for requests"...well...which requests specifically? Every one of them? I wanted to confirm that information. 

Additionally, actions speak louder than words. If the FDA is actually willing to start providing records to me, let's go! I provided OGIS and FDA with a list of 20 or so FOIA requests we could start getting fulfilled, which would only require FDA to forward me records they previously released to other parties, but which they refused to provide to me. 

Instead, OGIS took the stance that they actually wouldn't be helping me unless I "limited the number" of FOIA requests I had placed...which is the position FDA had taken. So...apparently FDA wasn't willing to start producing records after all, and OGIS wasn't going to call me and provide me the same resources and "fairness" they had been providing FDA for months. 

One day I wondered, how many people are rallying or in theory, working "against me" here? It could be what it is, "working against me." Or, it could be "communicating about me" in effort for an agency or two to ultimately work against me. We have FDA's Sarah Kotler. HHS's Michael Marquis, Kim Hutchinson, Brandon Gaylord, Jonathan Nelson. The FDA ombudsman employees Laurie Lenkel, Talisha Williams. OGIS employees Alina Semo, Carrie Mcguire, Martha Murphy. CDC employees Bruno Viana and Roger Andoh came into the mix. FDA has their attorney, Tracy Allen. FDA then has DOJ attorney's of which there are normally 3 or so attorney's representing FDA in court. 

When Even The Ombudsman Group Is Working Against You...

That's a rough estimate of around 16 individual people against one. The thing I love about being American is that I can challenge the government and challenge these individuals within government agencies who are making decisions not based on clear science, which produces results that appear to be most beneficial to the major lobbying groups. The sad thing here is how hard government employees fight against the media or normal citizens when it comes to certain actions that potentially have very negative consequences against health. 

Allowing processed foods to contain federally illegal adulterants because you have "enforcement discretion", while at the same time targeting food types many pet owners report as being healthful for their companion animals, brings us into the world of how the government is potentially allowing for or outrighting causing sickness and in some cases, death. FDA allowing for certain limits of "mold" (aflatoxin) in processed dry foods with ingredients from very questionable sources, while at the same time not allowing for raw pet foods to contain any amount of non pathogenic salmonella that will likely never be a serious risk to human or animal health, is a contradiction and bias at the very least. When you look at the fact that the FDA allows other animal feeds to contain any type of salmonella serotype unless it's the one or two types that are pathogenic to the animal being fed, more bias and contradiction starts to become evident. 

The interesting thing I've experienced when it comes to FOIA litigation is how the "roadblocks" FDA constantly tries to put up against me only lead me to finding out more information I may not have found out otherwise. The entire endeavour seems designed to shut the requester down most times. It has had the opposite effect with me, leading me more empowered about the law and more informed about the various ways agencies attempt to skirt their responsibilities under federal law. Once you put hundreds (or thousands) of hours over the course of years into this seemingly bizarre topic, this FDA regulating by their "opinion" instead of law actually starts to become a serious case of cronyism. How convenient for a few if the FDA regulates based on fear. How sad for us all if we outright believe the fear without serious question. 

-Kohl Harrington