By: Jessica Wasserman, Esq.
As more and more states legalize cannabis products, including edible products, the focus on ensuring the safety of these products has increased. For cannabis edibles, as for any other food product, safety for human consumption is front and center for consumers and for manufacturers. One bad experience for a consumer will harm the entire industry– and not just one company or brand. Consider, when a consumer gets sick from eating romaine lettuce, consumers stop eating romaine no matter the source or brand, and it takes months or years for consumer confidence to bounce back. So it will be for cannabis edibles, thus driving the incentive for the industry to work together to support and follow harmonized food safety standards.
The states that have legalized cannabis edibles, have each taken steps to lower food safety risk in edible products by implementing food safety requirements for manufacturing the product. At the federal level, food safety is regulated by the Food and Drug Administration pursuant to the Food Safety Modernization Act (FSMA). FSMA relies on mandatory food safety plans, recordkeeping and audits based on the well known international Hazard Analysis and Critical Control Points (HACCP) method of lowering food safety risk when manufacturing food. This same HACCP approach appears also in state regulation.
The National Environmental Health Association (NEHA) recently published a guidance document on food safety for cannabis-infused products that could provide a basis for regulatory coordination or harmonization among states:
The purpose of this document is to provide a comprehensive compilation of research on food safety provisions that have been approved, implemented, or are in trial phases throughout various states that have legalized cannabis as of March 2018. This document seeks to provide a list of considerations for states implementing a food safety program for cannabis edibles and provide examples of states that have strong written legislation to support their regulations and ensure its success. This document will focus solely on the food safety of cannabis-infused products (CIPs) from “seed-to-sale.” Regulations and/or information regarding the safety of cannabis consumption, . . lies outside the scope of this document and will not be discussed.
The NEHA report states that for the production and sale of cannabis edibles, it is important to include food safety plans into legislation. For many states, this includes a hazard analysis critical control point (HACCP) plan, general standard operating procedures (SOPs), inspections requirements, and recall plans, the report goes on to say.
As the cannabis edibles industry matures, these companies will have to learn about HACCP, which has a long history of development and use in Europe and in the United States. According to FDA, HACCP is “a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.” FDA’s HACCP Principles & Application Guidelines HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards:
Conduct a hazard analysis . The purpose of the hazard analysis is to develop a list of hazards which are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled. Once determined, appropriate control measures are identified. The analysis then provides a basis for determining CCPs in Principle 2.
Determine the critical control points (CCPs) . A critical control point is defined as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The potential hazards (identified in Principle 1) that are reasonably likely to cause illness or injury in the absence of their control must be addressed in determining CCPs.
Establish critical limits . A critical limit is a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP. Each CCP will have one or more control measures to assure that the identified hazards are prevented, eliminated or reduced to acceptable levels. Each control measure has one or more associated critical limits.
Establish monitoring procedures . Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and produces an accurate record for future use in verification. Its three primary purposes are to: facilitate tracking of the operation enabling action to be taken before a deviation occurs; show when a deviation does occur at a CCP; provide written documentation for use in verification.
Establish corrective actions . Because nothing is perfect, corrective actions should include the following elements: (a) determine and correct the cause of non-compliance; (b) determine the disposition of non-compliant product and (c) record the corrective actions that have been taken. Specific corrective actions should be developed in advance for each CCP and included in the HACCP plan.
Establish verification procedures . Verification includes the initial validation that the HACCP plan is scientifically and technically sound; that all hazards have been identified; and that, if the HACCP plan is properly implemented, these hazards will be effectively controlled. Another aspect is evaluating whether the facility’s HACCP system is functioning according to the HACCP plan.
Establish record-keeping and documentation procedures . Records should include a summary of the facility’s development and implementation of both the five preliminary steps and the seven HACCP principles, with rationale and supporting documentation.
If you are a cannabis edibles manufacturer and need further information for understanding HACCP or in implementing a HACCP plan, please contact Greenspoon Marder/Jessica Wasserman at [email protected]
