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Democracy Comes After FDA-CVM

People have power. Ordinary people, you and I, have power! That is an INCREDIBLE aspect of our country, but sadly it's not exercised by almost all citizens. I can understand. It's difficult to juggle it all. You have to wake up, go to work. Most people have kids, bills, and are probably only scraping by. Playing an active role as a proactive citizen is difficult. It takes serious work and focus, and you have to figure out how to keep plowing through when all the cards are stacked against you. 

The regulatory officials at FDA-CVM and most states know this as well, and they know it first hand. For almost their entire existence, they've been able to get away with regulating by their "opinion", making regulations in private, and respectfully, misleading the public on a variety of issues relating to human and animal health. One thing I've analyzed over the past decade is how some of these "pet food" topics are very nuanced and complicated, and how FDA-CVM whitewashes nuance and produces "one size fits all" decisions or solutions. We're just not in that world. We are in a world where a consumer may want to follow the whitewashing decisions of FDA-CVM, and feed pet foods that are allowed to manipulate and lie to the consumer. Some people just do not care. On the other hand, there are consumers that do care, and want to feed fresh, or raw pet foods with ingredients that can be verified. Over the past 5+ years, FDA-CVM employees have illegally targeted the raw sector of the pet food industry. That illegal "targeting by opinion" FDA-CVM employees are still carrying out, may have played a role in democracy coming to FDA-CVM. 

FDA-CVM employees refuse to hold public meetings where they develop animal feed ingredients for the pet food industry at large. The agency instead helps develop regulations in private, at a major cost for citizens who wish to participate. This is a violation of federal law, the Administrative Procedures Act. FDA-CVM also refuses to put their "opinion" regarding raw food, which they call a compliance policy, through proper rule making. They refuse to attempt to make their opinion "binding law", which would be subject to scientific review, public comment, and potentially reviews by court. FDA-CVM employees act more like an autocracy, where they make a decision and "stand firm" on their decision unless forced otherwise. For decades, FDA-CVM has went about their business with almost no regular feedback from citizens at large. That is, according to the past few years. 

Over the past few years, citizens appear to be biting back. It seems as if two democratic and legal processes are being used by citizens, the freedom of information act and the citizen petition process. Both are legally binding laws, and FDA-CVM can be held accountable in law for refusing to abide by these laws. Let's take this basic example. I have discovered first hand via FOIA requests I've made that FDA-CVM employees have sent out agency wide memos about me, instructing employees not to speak to me, and instead direct me to a specific FDA-CVM phone number or a anonymous FDA-CVM email address. Long story short, no one answers the phone number they provided me, nor does anyone call me back to speak to me if I leave a message. Almost always, no one answers me when I submit questions to the anonymous email address. 

However, if a citizen requests records through FOIA law, or if a citizen submits a petition to the FDA-CVM via the official citizen petition process, FDA-CVM can't ignore the requests as they do via their suggested "send a question to our anonymous email address" process. The agency is required by law to respond to citizen petitions within 180 days. FOIA law requires FDA-CVM provide copies of government records within 20 working days. Citizens who are otherwise ignored can receive some type of actual response via the citizen petition process, and this process is known as a form of "exhausting the administrative options." Using the "FDA-CVM is regulating by their opinion" as an example. I have submitted a citizen petition asking FDA-CVM to engage in proper rule making for this issue. If FDA-CVM rejects my petition, I have the option to bring suit against FDA-CVM in court, and fight the issue there. When I say, citizens have power. When we have FDA-CVM employees acting as though they're an autocracy, that is power! 

This all comes with some fascinating twists though. According to what I can gather via information on regulations.gov, there's been around 54 citizen petitions from various people submitted to FDA-CVM over the past few years. 13 of those petitions specifically ask FDA-CVM to withdraw from their "memorandum of understanding" with state regulator's private organization AAFCO, and instead promulgate regulations via public meetings. In my experience, when FDA-CVM is being challenged in ways they don't want or like, their first attempt is to try and claim "burden"! "We are burdened! You're harming us!" And that's exactly what they appear to be doing in their latest citizen petition response to me. 

On February 09, 2022, Steven Solomon of FDA-CVM stated to me via a legally binding citizen petition response: "Although we recognize and support your rights to request records under FOIA and to petition the government, this increase in FOIA workload diverts CVM resources that could be used for other public health programmatic work." Hold on. Wait. What? You support my rights to request records under FOIA and the citizen petition law? How specifically are you doing that? Why would an agency employee state such a thing, when legally they're required to comply with FOIA and citizen petition laws? And secondly, does FDA-CVM ever not recognize and support the rights of others under FOIA and the citizen petition law? FDA-CVM chooses what to support and not support? Interesting. 

Semantics aside, I want to zero in on Steven Solomon stating, "this increase in FOIA workload diverts CVM resources that could be used for other public health programmatic work." He doesn't state what the "other public health programmatic work" is, and how it's more important than a citizen exercising their rights under federal law. 

In a court filed document related to a FOIA lawsuit I filed against FDA-CVM, FDA admitted to the extent in which they're unable to fulfill their obligated legal duties in relation to FOIA. The FDA-CVM submitted the following "facts" to the court:

  • CVM is one of FDA’s smallest centers, and has one of FDA’s smallest center FOIA Staff.
  • Specifically, the CVM FOIA Staff consists of ten people: eight First Reviewers and two Second Reviewers. One of the eight First Reviewers is a full-time contractor. 
  • In the past few years, the CVM FOIA Staff has experienced an increased backlog of FOIA requests. In Fiscal Year (“FY”) 2018, the CVM FOIA Staff received 174 FOIA requests; in FY 2019, the CVM FOIA Staff received 377 FOIA requests; in FY 2020, the CVM FOIA Staff received 182 FOIA requests; and in FY 2021, the CVM FOIA Staff received 264 FOIA requests. As of December 2021 (FY 2022), the CVM FOIA Staff has received 55 FOIA requests. During this time, the CVM FOIA Staff’s backlog grew from 63 in 2018, to 121 in 2019, and to 204 in 2020. Currently the CVM FOIA Staff has a backlog of 336 FOIA requests. 
I found the increase in FOIA backlogged requests particularly interesting. In short, FDA-CVM received 174 FOIA requests in 2018, and had a backlog of 63 requests. Compared to 2021, FDA-CVM received 264 FOIA requests that year and the current backlog is 336 requests. This proposed a serious legal question under FOIA law. Does FDA-CVM intend to only ever have 8 employees? Do they plan on hiring more employees? Are they just allowing the problem of a massive backlog grow placing more of a burden on consumers who are requesting information related to FDA-CVM making regulations in private, and FDA-CVM regulating based on their "opinion"? If today FDA-CVM employees illegally acts by "regulating by their opinion", and if a citizen wishes to review those documents FDA-CVM based their actions on, FDA-CVM estimates the citizen may receive those documents in 2-3+ years time. To say FDA-CVM is creating a massive delay in being transparent with the public is an understatement. 

I also find the admission: "CVM is one of FDA’s smallest centers, and has one of FDA’s smallest center FOIA Staff" particularly interesting. FDA-CVM often touts itself as this powerhouse, protecting animal and human health. With such a small staff, are they actually doing that or are they only trying to portray an image of such? In September 2021, FDA-CVM held a "virtual listening session on the oversight of pet food", and CVM director Steven Solomon admitted, "FDA simply doesn't have enough resources to be everywhere at once". That's understandable, but that doesn't have anything to do with FDA-CVM regulating certain aspects of the pet food industry consistently and effectively. FDA-CVM knowing that mold in corn can cause death in animals eating those products, knowing that corn is one of the most abundantly used ingredients in the pet food industry, and then almost "never" inspecting that issue, isn't FDA-CVM not having "enough resources to be everywhere at once."

Can you see a little bit as to how FDA-CVM spins words in a generic, broad sense? I'll add to that, FDA appears to have quite abundant resources to engage in regulation by "opinion" instead of law. That action by FDA seems to be flowing from the hilltops. That action appears to benefit the dominating corn based sector pet food industry. FDA not regularly inspecting for adulteration due to mold in corn based pet food also seems to benefit the dominating corn based sector of the pet food industry. This then leads us into FDA-CVM and their "enforcement discretion" actions, where FDA-CVM ignores certain "public health" issues and focuses on other "public health" issues. Aka, they do what they want, more akin to an autocracy. Or, a petocracy. 

When I analyzed various serious and ongoing issues in the pet food industry around 5 years ago, I saw how FDA-CVM would of course continue to regulate by opinon, and create regulations in private, primarily because they received almost no blowback from doing so. If you were getting $80,000-$250,000 per year as a government employee, and you had a choice to do things the more difficult "correct way", or the "easy way" where you get way more free time, and you never get any blowback, what would you do? Well, it seems FDA-CVM employees have grown really comfortable over the years with cutting citizens out of the democratic, or burdening them as much as possible. Since FDA-CVM currently refuses to conduct themselves in a more democratic method, it seems individual citizens are bringing democracy to FDA-CVM, and forcing the agency employees to engage in the democratic process. Judging by FDA-CVM's admission in court, the democratic process is on a skyrocket of growth for the foreseeable future. 

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