Marijuana Business Magazine January 2020

Marijuana Business Magazine | January 2020 88 happens and running a mock recall in advance of any problems,” said Lezli Engelking, founder of FOCUS. Companies can follow templates to develop their procedures or work with a third-party consulting firm to build their recall plans. Cultivators may decide to create a recall team—consisting of their quality assurance lead, master grower and other relevant personnel—to serve as point people in recall situations. “Outside of people who are involved when writing the recall plan, you want to make sure all senior leadership is comfortable with it and understand it. When a recall happens, time is of the essence, and you don’t want to have all this internal disagreement on what you’re going to do. It should be a streamlined process,” Engelking said. Cultivators can test the efficiency of their recall plans by running “mock recalls,” where the company traces a product from the raw ingredient level to the finished product in the marketplace, verifying communication systems and confirming the effectiveness of record- keeping. Health Canada requires license holders to run recall simulations at least every 12 months. IDENTIFY A RECALL SITUATION A cultivator might receive a complaint from regulatory agencies, consumers or the supply chain with concerns about possible regulatory or health issues in- volving a product. The recall team then must determine if it’s necessary to pull the product from the market. “Complaints should all be logged and kept on file,” Engelking said. “If it’s a big one or there’s a real health and safety risk, that’s when you want the recall team to look at how broadly the product’s been distributed and what the health risks are: Is there a risk to someone’s life? Is there a risk of illness?” she said. Conducting a Health Hazard Evalua- tion allows cultivators to determine the next steps during a recall. For instance, if a company is dealing with what the U.S. Food and Drug Administration considers a Type One risk—where there’s reason- able probability that using the product will lead to serious negative health conse- quences or death—staff needs to get the word out immediately. A Type Three risk, where health issues aren’t likely, such as a labeling issue, doesn’t always require the same sense of urgency. After a recall situation is identified and assessed, the company should gather relevant documentation such as product test results, a distribution list of who received the product and a log of who handled the cannabis, if possible. Like everything else in the industry, documentation is critical, Romanow said. “Organizations should have forms in place that provide a checklist for the diligence that will be conducted and an ability to evidence prompt, efficient compliance with internal policies and procedures,” he said. A big part of the recall plan is detail- ing whom to notify and how. Regulators and the business’ supply chain typically receive a recall notice. A news release is usually issued to media outlets. Some regulators have rules about how long operators can take to get the word out. Health Canada advises business- es to reach out to consumers and the supply chain the same day they identify a Type One risk situation, within four business days for a Type Two risk, in which health concerns are remote, and within seven days for the least severe Type Three risk scenarios. WORKING WITH REGULATORS State and local health officials might take a more hands-on approach during recall events. In Denver, regulators conduct their own review after receiving a complaint or referral about issues with marijuana plants or products. “A complaint would trigger an investigation from us, so we’d go out to the facility, whether it was a dispensary or cultivation site. And at that point, our typical next step is to issue a testing order to the business,” said Kara Lavaux, food and cannabis supervisor with the Denver Department of Public Health and Environment. If the test shows contamination, city officials often work to put controls in place to limit exposure of the tainted marijuana plants or products. A hold order, for example, might be issued to prevent any product on site from being distributed to others in the supply chain. Ultimately, the goal for the city and businesses is the same, said Abby David- son, Denver’s food safety and marijuana program manager: to ensure the product that gets to the consumer is safe. Abby Davidson is the food safety and marijuana programmanager with the Denver Department of Public Health and Environment. Courtesy Photo Readying for a Recall Kara Lavaux is the food and cannabis supervisor with the Denver Department of Public Health and Environment. Courtesy Photo