According to the Centers for Disease Control and Prevention, there are 180 species of Aspergillus, but fewer than 40 of them are known to be harmful to humans. The most common is called Aspergillus fumigatas. This fungus can be found in almost all things, from food to cannabis.
CEO of Allay Consulting, Kim Stuck has dedicated her career to helping make sure others are doing things safely when it comes to manufacturing and distributing products. Throughout her career, Stuck has seen all sides of the cannabis industry and speaks on what cannabis businesses can do to provide the safest product possible.
“Before the firm, I was a regulator for the state. When you are a regulator, you’re not allowed to give businesses advice or tell them how to fix their problems. You really just only get to state the regulation. It’s not your job to explain it to them. That is something that really bothered me. It was very hard to not just jump in and be like, ‘You can fix this problem with a $6 part from Home Depot’. One day, I was jokingly saying that maybe I should start my own consulting company, and my friends were like, ‘Yeah. You should definitely do that.’ In 2017, I started my own company, helping people comply with regulations and understand what they actually mean because, as we all know, regulations are written in that lawyer jargon that nobody can really understand very well unless you really know it,” Stuck explained.
Specializing in operational compliance, Stuck has helmed Allay Consulting for more than six years, “We work in all 50 states, as well as in other countries. We have clients in Canada, Mexico, Israel, and even South Africa. We’re kind of all over the place. What we really specialize in is operational compliance, but what we also assist with employee safety, OSHA, which is not required really yet, but it will be. And then we also assist with consumer safety as well. Making sure that you have the safest product possible while keeping your employees safe is what we do,” Stuck said.
Mold has been one of the most prevalent issues for cannabis cultivators in recent years, and Missouri has not been exempt from that.
Mold of any kind can do irreparable harm to a marijuana company’s bottom line, but it can also damage a brand’s public image and perception.
Aspergillus is perhaps the most widely talked about and prevalent form of mold in cannabis.
What exactly is Aspergillus?
Aspergillus is a mold. It’s a kind of black mold that is also found in other industries as well. In the grape industry, it’s really common in wine and things like that. It’s a mold that we’ve known about for a really long time, that can be pretty dangerous if the spores are inhaled, and it’s usually people who are immunocompromised that are affected by it. However, at high enough amounts, anybody can get sick. It can actually grow in your lungs, and that’s what the whole issue is with having Aspergillus on cannabis.
It’s ambiguous to our environment. That means that it is essentially everywhere. The spores are carried by wind, air, and ventilation; so it is actually pretty easy to get Aspergillus. It really doesn’t grow in drier climates, so indoor cannabis companies are like a perfect spot for it to flare up. They like that really wet, damp environment that’s warm. That’s why we have to test for it to make sure that it’s at levels that are low enough that it’s not gonna harm anybody.
In many states, they have a pass-fail, which means if it’s non-detected then they pass, which I don’t think that that’s the right way to go. I think that they should have a number, but the problem is that number hasn’t been established yet for the cannabis industry. It’s been established in other industries, But once again, those are things that can be washed off. Take grapes for instance, it can be washed off before you eat them. With cannabis, you can’t decontaminate it before you smoke it.
Symptoms that can relate to getting sick from Aspergillus
The symptoms relate a lot to those of the flu and COVID-19. It can cause wheezing, shortness of breath, cough and fever. In severe cases it can even cause death.
The thing is it can be really dangerous, but it’s really dangerous for people who are immunocompromised. When your immune system can’t fight off the mold from growing in your lungs. And that’s why we’re concerned about it because in the cannabis industry, we tend to serve those immunocompromised populations, and so we really need to be careful of that.
What are some ways businesses can help prevent mold from growing in their products?
Making sure there is airflow and that you’re controlling your humidity levels is probably the best way to mitigate it. Also just keeping your facility really clean, people are wearing PPE because they could be dragging the spores from outside into the facility. So if they’re wearing shoes that have been outside and wearing them through the grow, that kind of thing could happen.
Any cross-contamination issues, or if you do have a problem with one area, tracking it from one area to all the areas in your grow is always always a bad thing too, so just take care of it. The main thing is keeping airflow, humidity low, and temperature in its right place,
What are some steps that should be taken if a product gets recalled?
They should have a recall plan in place or a corrective and a corrective action preventive action plan, in place in their facility. If you have GMP certification, then you have these kinds of plans in place. It will explain what to do in the case of a recall and how to act. At the very least, they should be reaching out and telling people that things were recalled.
This is something that happens in all industries. They shouldn’t feel terribly bad about it because in wholesale food, there are recalls all the time. If something gets mixed up or if the flour had salmonella in it they have to do a recall. It’s pretty normal in other industries just reaching out and informing the public of what is going on. Being really transparent is the smartest thing that you can do as a business.
What certifications can businesses get to help with these kinds of issues?
Having GMP certification is probably the number one way to help your company in general. GMP is good manufacturing practices and GACP is good man or good agricultural practice and collection practices. So they’re certifications from third party companies.
Our company helps people get those certifications. Part of it talks about what to do in a recall, how to correct those actions, and how to record them to make sure that if something does go wrong, a regulator can come in, and you’ve got everything that you need that you’re supposed to have.
Obviously, you know, the FDA isn’t involved yet. It will be, and that’s another part of what we do is help people get ready for federal legalization. Once the FDA starts getting involved, things like GMP are just required. We want to have as many Companies, you know, get in and do what they’re supposed to be doing, before that happens.
What does the process look like getting the GMP or GACP certification?
We’ve kind of gotten it down to a science because we’ve been doing it for so long. Initially, we would do a gap analysis, which is essentially an audit to see where your company is at. That’s like the first step of everything because the physical facility has to be built in a certain way for it to even be GMP certified. There are ways to fix things and then, you know, make sure that things are the way they should be.
Then after that, we help them find their certifying company. Because you have to have a certifier. We can’t be the certifier and the consultant since they have to be separate. We work with 6 right now, that are in the cannabis industry, which is pretty cool.
From there, we start writing all their SOPs, Keys, all their documentation, and train their staff the way that they should be trained. And then we do another gap analysis, see where they’re at, and then we call in the certifying body, and then when the certifying body finds, you know, some violations, we have to write a corrective action plan for that, and if they accept it, then you get the certification, and then the certifier comes back every year.
At that point, we kind of say goodbye and move on to the next project, but if they need anything they can always reach back out.
How long is the process of getting certified?
It does depend, but it takes us about 170 billable hours, so usually about 6 to 8 months, to get everything done. It isn’t something that happens overnight. I’ll have people that call me and say, can we get this next month? And I’m like, that’s not really how it works. And a lot of people might have more work or less work because everybody’s different, so it’s really hard to give an exact number, but that’s usually where we fall.
If you are wanting to get certified, now is the time because it will take some time to get everything taken care of. You can reach out to Allay Consulting for help in the process.
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