In this installment of the ImEPIK Q&A series, we talk to Dr. Kathy Knutson, a food safety expert in the cannabis industry who specializes in the Food Safety Modernization Act and PCQI training. Dr. Knutson updates us on the federal Cannabis Administration and Opportunity Act, which U.S. Senator Cory Booker reintroduced in July, as well as changes in who is seeking FSMA-related training.
ImEPIK: It seems that quite a few states have approved medical and recreation-use in recent years, but that’s slowed down in 2022. At the same time, revised federal legislation has been reintroduced for the cannabis industry.
KK: I’ve been in the cannabis industry for maybe five years now, and in everything we do, we say ‘when there is legalization’ and “when the FDA has authority.’ It’s always with the caveat that we don’t even know if the FDA will have authority over cannabis products.
So, the second version of this bill was introduced into the Senate in July. Cory Booker is the primary sponsor … there are five senators that have presented this. It legalizes cannabis and gives authority to both the FDA, which would have control over all cannabis products, including smoke, vape, topicals, edibles, and what we think of as dietary supplements – they would have public health responsibility.
And the other agency is the TTB, the Alcohol and Tobacco Tax and Trade Bureau, also known as the Tax and Trade Bureau. Taxation on the companies is a heavy burden. California is going through a really rough time because of the cannabis companies being under heavy taxation. Many companies have had to close because they just can’t handle it. So the taxation at the federal level would be sequential over five years, and the proposed maximum is 25%, but I don’t think the industry can handle 25% taxation.
ImEPIK: Gov. Gavin Newsom recently announced the state plan to expand its crackdown on illicit cannabis growers and trade.
KK: Yes, the black market and the gray market in the cannabis industry are still thriving.
So, TTB would handle the taxation because it’s aligned with the duties they already have. The big deal in terms of legalization is that cannabis would be removed from the Controlled Substance Act and would no longer be listed as a Schedule I drug. The end goal is to get cannabis – and, in the meantime CBD – classified as food additives, which have a legal definition under FDA rule. If it’s a Schedule I drug, it certainly can’t be a food additive. I was presenting a webinar the other day, and I went off on a tangent and said to the class, ‘Do you know that all CDB edibles are illegal at the federal level because CBD is not an approved additive.’ They were all shocked. One said, ‘But it’s at my corner gas station!’
So this would take cannabis out of the hands of the DEA, which is huge. But the cannabis industry does not want re-scheduling, which would be moving it from Schedule I to Schedule III or Schedule V. We want it off the Controlled Substance Act completely.
The law would establish a Center of Cannabis Products that would basically be under the authority of the FDA, but there would be maybe ten other departments that would be represented in the center. With that center, the FDA would be working heavily with the National Institutes of Health, and that is in the whole public health realm. It’s not just the FDA having all this authority.
They will be charged with rule-making, so we would have to wait for them to write the rules. If you’ve been along on the ride with the FSMA (Food Safety Modernization Act), it was signed in 2011 by President Obama, but then it took a lawsuit against the FSMA to force them to write the rules. There now are a total of 10 rules under FSMA, and they are still being rolled out. One of the more recent ones is on laboratory accreditation.
The rule’s premise is that the FDA, in emergency situations such as a recall, wants the ability to send samples to third-party contract laboratories. Right now, they don’t have the authority to do that. They can only test them at FDA laboratories. There would have to be an approval process, a recognition process of some kind.
Personally, and I communicate this often, if I were a food manufacturer sending samples on a routine basis to a third-party contract laboratory, and I knew they were doing side-by-side samples for the FDA as well, I would be very concerned.
ImEPIK: Is there a possibility there could be a sampling program of cannabis edibles through the FDA?
KK: FDA has a microbiological sampling program, and every year they have a special assignment called Microbiological Surveillance Sampling. I can totally see a microbiological sampling year of edibles, which would be normal for the FDA, which also goes and gets market samples to test.
ImEPIK: So that would be possible only after federal legalization.
KK: Certainly, we’re not close to getting this legislation passed. It was initiated in the Senate, so it would have to pass the Senate, and then it would go to the House. Despite that, this is still tremendous progress.
The other rule in the works right now is the Safe Banking Act, and we are very hopeful it will get passed before the end of the year.
ImEPIK: With the CAOA, are we seeing any specific food regulations for edibles with it, or will it give the power to regulatory agencies to come up with those regulations?
KK: What we see on the food side is the FDA not doing anything. It’s really frustrating because there’s so much good work being done on cannabis and, for the most part, the FDA isn’t even at the table. They don’t even have the authority to be there, they can’t even have budgetary line items, can’t have resources dedicated to cannabis because they don’t have the authority.
ImEPIK: What do you see as the prognosis of the legislation?
KK: It’s really early to say because it was just reintroduced in July, but I am very hopeful because President Biden announced the release of prisoners in federal prison for possession. It’s a double-edged sword. On the one hand, there aren’t very many. Most people in prison for cannabis possession are in state facilities.
But when we were going through the presidential campaign process, at one point, there were 17 Democratic candidates, and President Biden was the only that did not definitively say that he was in favor of legalization, and personally making that announcement, that really was hopeful. That was a bright, shining moment for the cannabis industry, to see the President of the United States take that step to further cannabis legalization.
To switch to another topic, I do have something else to report. I deliver Preventive Controls Qualified Individual (PCQI) training on behalf of NSF, and the type of people that are getting training now, is changing. I had a facility manager at PCQI training, and he was from a corporation. He said all plant managers from the corporation were getting the training. That’s huge, absolutely huge.
At almost every course I teach, I see people from maintenance and sanitation. This is after they already have PCQIs at their facilities. More and more, I would say over the last few months, when I ask my classes if they are the first PCQI, rarely are they the first PCQI at their company. Companies are sending their backup PCQIs.
In 2016, when I first started the training, everybody was new of course, so most facilities only had one. And one of the big tasks for a PCQI is that they have to do a record review. Legally, through FDA, monitoring records have to be reviewed within seven working days. So if they were meeting the law, they weren’t going on vacation and weren’t getting sick because they had to do their job.
Now we see all these backup PCQIs; they’re sending groups to be PCQIs. I also do private training, and I did two weeks back-to-back for a company that already had three PCQIs at their facility, and one week I trained seven people, and the other week I trained nine.
PCQI is not just for quality assurance – we’ve really moved beyond that. What I really want is to see purchasing personnel trained as PCQIs because they’re communicating with suppliers, and that communication is critical for any supplier that has an ingredient where they control the hazards.
In the food safety world, we’ve been told that FDA inspections will be a lot more paper audits. That’s what they do for the Foreign Supplier Verification Program. With our heavy documentation in the food industry, it would be very feasible for a food company to download PDF copies and other documents to review so that the time on site can be limited.
Before my cannabis work, I never thought I would be grateful for federal legislation. Now I see the vacuum and the void that occurs when you do not have federal legalization. We need it.
Living through this time of no federal legalization is highly stressful. People are not able to run their businesses effectively. People want to help patients, and they want to do the best for their patients. Without federal legislation, there is just not a level playing ground, and the consumer and the patients are not getting the full value of the industry.
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- Level I: GMPs and the Pyramid of Edible Safety
- Level II: The Edible Safety Plan
- Level III: PCQI Online
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