extraction equipment

Implementing a HACCP Plan in Cannabis Processing

By Aaron G. Biros
10 Comments
extraction equipment

Hazard analysis and critical control points is a management system that identifies and addresses risks to product safety.

Hazard analysis and critical control points (HACCP) is a robust management system that identifies and addresses any risk to safety throughout production. Originally designed for food safety through the entire supply chain, the risk assessment scheme can ensure extra steps are taken to prevent contamination.

The FDA as well as the Food Safety and Inspection Service currently require HACCP plans in a variety of food markets, including high-risk foods like poultry that are particularly susceptible to pathogenic contamination. As California and other states develop and implement regulations with rigorous safety requirements, cannabis cultivators, extractors and infused product manufacturers can look to HACCP for guidance on bolstering their quality controls. Wikipedia actually has a very helpful summary of the terms referenced and discussed here.

Dr. Markus Roggen, vice president of extraction

The HACCP system consists of six steps, the first of which being a hazard analysis. For Dr. Markus Roggen, vice president of extraction at Outco, a medical cannabis producer in Southern California, one of their hazard analyses takes place at the drying and curing stage. “When we get our flower from harvest, we have to think about the drying and curing process, where mold and bacteria can spoil our harvest,” says Dr. Roggen. “That is the hazard we have to deal with.” So for Dr. Roggen and his team, the hazard they identified is the potential for mold and bacteria growth during the drying and curing process.

The next step in the HACCP system is to identify a critical control point. “Correct drying of the flower will prevent any contamination from mold or bacteria, which is a control point identified,” says Dr. Roggen. “We also have to prevent contamination from the staff; it has to be the correct environment for the process.” That might include things like wearing gloves, protective clothing and hand washing. Once a control point is identified, the third step in the process is to develop a critical limit for those control points.

A critical limit for any given control point could be a maximum or minimum threshold before contamination is possible, reducing the hazard’s risk. “When we establish the critical limit, we know that water activity below 0.65 will prevent any mold growth so that is our critical limit, we have to reach that number,” says Dr. Roggen. The fourth step is monitoring critical control points. For food manufacturers and processors, they are required to identify how they monitor those control points in a written HACCP plan. For Dr. Roggen’s team, this means using a water activity meter. “If we establish the critical control point monitoring, water activity is taken throughout the drying process, as well as before and after the cure,” says Dr. Roggen. “As long as we get to that number quickly and stay below that number, we can control that point and prevent mold and bacteria growth.”

One of the cultivation facilities at Outco

When monitoring is established and if the critical limit is ever exceeded, there needs to be a corrective action, which is the fifth step in a HACCP plan. In Dr. Roggen’s case, that would mean they need a corrective action ready for when water activity goes above 0.65. “If we don’t have the right water activity, we just continue drying, so this example is pretty simple,” says Dr. Roggen. “Normal harvest is 7 days drying, if it is not dry enough, we take longer to prevent mold or bacteria growth.”

The sixth step is establishing procedures to ensure the whole system works. In food safety, this often means requiring process validation. “We have to double check that our procedure and protocols work,” says Dr. Roggen. “Checking for water activity is only a passive way of testing it, so we send our material to an outside testing lab to check for mold or bacteria so that if our protocols don’t work, we can catch those problems in the data and correct them.” They introduced weekly meetings where the extraction and cultivation teams get together to discuss the processes. Dr. Roggen says those meetings have been one of the most effective tools in the entire system.

Dr. Roggen’s team identified worker safety as a potential hazard

The final step in the process is to keep records. This can be as simple as keeping a written HACCP plan on hand, but should include keeping data logs and documenting procedures throughout production. For Dr. Roggen’s team, they log drying times, product weight and lab tests for every batch. Using all of those steps, Dr. Roggen and his team might continue to update their HACCP plans when they encounter a newly identified hazard. While this example is simplistic, the conceptual framework of a HACCP plan can help detect and solve much more complex problems. For another example, Dr. Roggen takes us into his extraction process.

Dr. Roggen’s team, on the extraction side of the business, uses a HACCP plan not just for preventing contamination, but for protecting worker safety as well. “We are always thinking about making the best product, but I have to look out for my team,” says Dr. Roggen. “The health risk to staff in extraction processes is absolutely a hazard.” They use carbon dioxide to extract oil, which carries a good deal of risks as well. “So when we look at our critical control points we need to regularly maintain and clean the extractor and we schedule for that,” says Dr. Roggen.

Gloves, protective clothing, eyewear and respirators are required for workers in the extraction process.

“My team needs respirators, protective clothing, eyewear and gloves to prevent contamination of material, but also to protect the worker from solvents, machine oil and CO2 in the room.” That health risk means they try and stay under legal limits set by the government, which is a critical limit of 3,000 ppm of carbon dioxide in the environment. “We monitor the CO2 levels with our instruments and that is particularly important whenever the extractor is opened.” Other than when it is being opened, Dr. Roggen, notes, the extractor stays locked, which is an important worker safety protocol.

The obvious corrective action for them is to have workers leave the room whenever carbon dioxide levels exceed that critical limit. “We just wait until the levels are back to normal and then continue operation,” says Dr. Roggen. “We updated our ventilation system, but if it still happens they leave the room.” They utilize a sort of double check here- the buddy system. “I took these rules from the chemistry lab; we always have two operators working on the machine on the same time, never anyone working alone.” That buddy check also requires they check each other for protective gear. “Just like in rock climbing or mountain biking, it is important to make sure your partner is safe.” He says they don’t keep records for employees wearing protective gear, but they do have an incident report system. “If any sort of incident takes place, we look at what happened, how could we have prevented it and what we could change,” says Dr. Roggen.

He says they have been utilizing some of these principles for a while; it just wasn’t until recently that they started thinking in terms of the HACCP conceptual framework. While some of those steps in the process seem obvious, and it is very likely that many cannabis processors already utilize them in their standard operating procedures and quality controls, utilizing the HACCP scheme can help provide structure and additional safeguards in production.

Comments

  1. Lee Ann Merrill

    In reading this, and being new to the hemp processing field, it strikes me that there are two different categories of hazards – product contaminants such as bacteria and mold, and THC levels above legal levels for hemp products. With food, everything is concerned with things that could make consumers ill. With hemp, the same concern is there but also the need to keep THC levels below a certain level at various stages. Does HCAAP address the latter issue, and if so, how?

    1. Aaron Biros Post author

      Hey Lee Ann,

      The short and sweet answer is that HACCP does address THC levels- being that the hazard is going up the legal threshold and the critical control point being the extraction process of raw material (hemp) into a concentrate. There are also remediation methods to re-process hemp extracts to keep it below the legal threshold. If you’re interested in learning more about HACCP in cannabis, we have a webinar on it tomorrow actually. It’s free to sign up here: https://register.gotowebinar.com/register/4547085720706538510

      And here is the event page where you can see the agenda: https://www.eventleaf.com/CQConference_Virtual2020

  2. Lee Ann Merrill

    Thanks! I had found it and signed up! Did you mean to say that the hazard is exceeding the legal threshold? For the situation I’m working on, the extraction process involves multiple steps so I’m thinking there are multiple CCPs involved. Whole plants are received, then dried and cured. So any plant part must be treated as if it exceeds the threshold unless and until tested as otherwise. Then afterwards, when everything is ground together and that material tested, there must be assumptions about representative sample size and homogeneity so that test results are valid for an entire batch. Then after extraction and testing that material, and then further along at final product, again assumptions or principles about homogeneity and sample size as representative of/valid for an entire batch. That’s what I’m grappling with. Thanks so much for your response!

  3. Lee Ann Merrill

    Thank you so much for forwarding my question. The penny has dropped. For purposes of the product that I am concerned with, THC is basically considered a contaminant. So that allows me to put it back into the group of contaminants and treat them the same way.

  4. Lee Ann Merrill

    Hi Aaron – sorry I’m contacting you this way I’m not locating an email or anything for you – after the webinar today I saw a feedback screen pop up but got distracted and accidentally closed it. If you’d like feedback I’d be happy to answer the questions – also want to see how I can connect with Josh Chapelle and his offer of two hours’ consultation time. Thank you again! – Lee Ann

  5. Aaron Biros Post author

    And if you want to provide feedback, feel free to go into the app and rate the presentations and leave a comment if you wish. But don’t worry about it- you can always leave us some feedback next week for the lab testing episode or any other episode you tune in to throughout the Fall!

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