How to Maintain Regulatory Compliance in Cannabis and Hemp Extraction
by Michael Leavitt of Root Engineers
Whether you are just getting into the extraction business or you have been in it for a while, maintaining your extraction facilities compliance is an active process. The cannabis industry is in a constant flux, and staying current on all the laws and regulations can be quite a task.
And as the hemp, medical, and recreational cannabis industries continue to mature, we continue to see a significant demand for extracts. Getting and maintaining your extraction facility compliance is crucial to staying in the cannabis market long term. This article will discuss some key considerations related to operational compliance to keep your extraction facility running and out in front.
Maintaining compliance for existing extraction facilities
Develop and maintain robust standard operating procedures (SOPs) covering issues like safety, equipment use, maintenance, testing, quality control, and regulatory requirements. The SOPs should be in-keeping with regulatory requirements, manufacture equipment requirements, and best practices.
Safety should be the number one compliance concern for extraction facilities. Employers should be providing ongoing employee safety training. Chapter 38 of the National Fire Protection Association's regulations states that, “For other than approved, unattended processes, the extraction process shall be continuously staffed.” That staff shall be trained in the extraction process, the transfer of solvents where required, and emergency procedures. Furthermore, all staff training records must be maintained on-site and available for inspection by the local authority upon request.
Regular preventive maintenance and inspections should be completed on all extraction equipment and supporting systems. Maintenance records should be kept and all repairs should follow manufacture and regulatory guidelines to ensure the integrity and the certified listings are not voided. Pressurized vessels often used in extraction processes can require routine certified inspections; requirements can vary between states and jurisdictions, so owners should be familiar with local requirements. Supporting equipment like gas sensors, emergency exhaust fans, and backup power generators should all be maintained and tested to ensure your facility remains in compliance.
Maintaining compliance in existing extraction facilities while optimizing workflow, expanding, or upgrading
Whether you are moving equipment to improve workflow, looking to upgrade equipment, or expand your extraction operations to keep up with the market’s growing demand, maintaining your compliance is essential. But this requires several considerations. Optimizing workflow is critical as techniques change and processes are refined. Adjusting layout may be one option to improve optimize workflows. However, keep in mind that if you are moving non-listed pieces of equipment that require disassembly, your jurisdiction may require it to be re-inspected. The inspection often requires a third party or the engineer of record to ensure the equipment was correctly reassembled and has been safely put back into operation. Supporting systems must also be considered with the new layout; access to emergency equipment like safety showers, eyewashes, and routing signage must be considered and altered as required. Exhaust hoods, sensors, control panels, may need to be relocated, and electrical equipment may need to be upgraded or further relocated to meet the area hazard classification requirements.
If you are doing more than just optimizing workflow and are looking to change solvents, add capacity to existing extraction equipment, add new extraction equipment, or increase the total solvents kept on hand then the process of maintaining compliance is further complicated. When replacing or adding new equipment, you must know area hazard classification requirements of the equipment and solvents that will be used. You may also need to assess the number of control areas you are allowed to have and are currently using. The maximum allowable quantities (MAQs) per control area should be assessed. When adding capacity to your extraction system, ensure the total amount of solvents used and stored do not exceed control areas MAQs. To maintain compliance, modifications to existing equipment will most likely require engineering review and third party verification. Violating maximum allowable quantities per control area may not only endanger life and property in the event of a fire, it may violate your occupancy classification, incur fines, and it may also void your insurance.
Moving, replacing, or adding capacity to existing equipment can trigger permit requirements and additional inspections. Knowing about these requirements and planning them in advance will save you lots of time in the long run. In many jurisdictions, the permitting and inspection process takes weeks, if not months, even with all the proper procedures being followed. Any changes you have made to your extraction process should be documented, any applicable SOPs should be updated, and employees should be retrained.
Looking ahead at future compliance requirements
With this industry still developing, it is difficult to say what tomorrow’s regulatory requirements will be with any certainty. But we can keep a few things in mind as we try to forecast what is coming down the pipe. We have regulatory requirements and laws for two primary reasons: to ensure safety and to ensure rights. As the cannabis industry has grown, we have seen many laws and regulations affecting people’s safety and rights. With that, businesses must keep the driving force and the intent of these laws and regulations in mind for their employees and customers. This will help predict future changes and make appropriate business decisions in the present while preparing for the future.
For example, the US Food and Drug Administration (FDA) has not established good manufacturing practices (GMP) for medical and recreational cannabis because it remains federally illegal. However, many owners are implementing GMP requirements now in anticipation of national legalization. To obtain GMP compliance, owners consider aspects of the production process like materials, premises, equipment, storage, record-keeping, hygiene, product development, etc. If GMP considerations are not taken into account in the early design phases, it can be costly and impact production to go back after the fact and retrofit equipment and facilities to meet compliance requirements.
At the end of the day, maintaining your compliance is an active process, not just a box to be checked at the beginning of a project. Extraction can be a dangerous process; ensuring ongoing safe operation and a safe product is vital to an extraction processor’s success. When considering making changes to your extraction facility, be sure to bring in the right team early that have the necessary knowledge to navigate the regulatory process and maintain compliance to keep your operation running smoothly.