Overview
Chapter 55 of the Acts of 2017 established the Cannabis Control Commission (CCC) as the independent agency responsible for developing and enforcing regulations over the marijuana (or cannabis) industry in Massachusetts. According to its website, CCC’s mission is “safely, equitably and effectively implementing and administering the laws enabling access to medical and adult use [or recreational] marijuana in the Commonwealth.” CCC is located at 2 Washington Square in Worcester.
According to Chapter 55 of the Acts of 2017, CCC has five commissioners, which include the following:
[One commissioner] of whom shall be appointed by the governor and shall have a background in public health, mental health, substance use or toxicology; 1 of whom shall be appointed by the attorney general and shall have a background in public safety; 1 of whom shall be appointed by the treasurer and receiver-general and shall have experience in corporate management, finance or securities; and 2 of whom shall be appointed by a majority vote of the governor, attorney general and treasurer and receiver-general, 1 of whom shall have professional experience in oversight or industry management, including commodities, production or distribution in a regulated industry and 1 of whom shall have a background in legal, policy or social justice issues related to a regulated industry.
An executive director, appointed by the commissioners, oversees CCC’s day-to-day activities. CCC received state appropriations of $7,987,871; $13,419,742; and $15,196,869 for fiscal years 2019, 2020, and 2021, respectively. According to CCC officials, in January 2019, CCC had 40 staff members, including the commissioners and the executive director. By December 31, 2020, CCC had 86 staff members, including the commissioners and the executive director.
Massachusetts Recreational Marijuana Industry
On November 8, 2016, Massachusetts Ballot Initiative Question 4 passed with 53.6% of the vote. On December 15, 2016, marijuana was legalized in Massachusetts for people 21 years of age and older. On July 27, 2017, the Legislature approved Chapter 55 of the Acts of 2017, CCC’s enabling statute. The inaugural commissioners were appointed on September 1, 2017, and CCC’s executive director was hired in October 2017. The first licensed sales of marijuana products for recreational use in Massachusetts began in November 2018. According to CCC officials, some of the earliest recreational marijuana products originated through the medical marijuana market, which was regulated by the Department of Public Health. Medical licensees initially could transfer some existing plants and products that had successfully passed the Department of Public Health’s testing protocols to their recreational inventory.
In accordance with Chapter 55 of the Acts of 2017, oversight of the Medical Use of Marijuana Program transferred from the Department of Public Health to CCC in December 2018.
CCC Licensure
All businesses that operate in the Massachusetts marijuana industry must be licensed by CCC, including medical marijuana treatment centers (previously known as registered marijuana dispensaries) that were previously licensed under the Department of Public Health before December 2018. CCC issues the following licenses, for recreational marijuana establishments (MEs) and medical marijuana treatment centers, to businesses intending to cultivate, manufacture, transport, test, sell, or deliver marijuana products.
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Medical Marijuana Treatment Center |
Marijuana Research Facility |
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Marijuana Cultivator |
Independent Testing Laboratory |
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Craft Marijuana Cooperative |
Standards Testing Laboratory |
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Marijuana Product Manufacturer |
Microbusiness |
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Marijuana Retailer |
Delivery-Only Licensee |
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Existing Licensee Transporter |
Social Consumption Establishment |
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Third-Party Transporter |
Delivery Endorsement |
To obtain a license, an applicant must first host a public community outreach meeting to inform the public of its proposal to open an ME in the community and present details—including its location, operation, and compliance with local ordinances and bylaws—and respond to any concerns the public may have. The applicant documents the meeting on a CCC-provided Community Outreach Meeting Attestation Form and submits the form to CCC and the municipal government. The municipal government uses this information to assess the impact of the proposed ME on the community and negotiates a Host Community Agreement with the applicant if it determines that the ME would benefit the community. The applicant then submits a license application to CCC that includes the Host Community Agreement, a list of individuals with a controlling interest in the business, its financial resources, its operating policies and procedures, and other documentation specific to the type of license desired in accordance with CCC’s regulations.
CCC sends the applicant a notice when its application is deemed complete, informing that CCC (1) has sent a notice to the applicant’s host municipality, requesting verification that the applicant is in compliance with the municipality’s local ordinances or bylaws within 60 days and (2) will consider the application for a provisional license within 90 days, in accordance with state law. During that 90-day period, CCC runs a comprehensive background check on all individuals affiliated with the application. If CCC ultimately approves an application, the applicant receives a provisional license once the applicant pays the appropriate fee for the business type.
As of December 31, 2020, CCC had approved 212 final recreational licenses and 85 final medical-use licenses. In addition, CCC had approved 293 provisional recreational licenses and 36 provisional medical‑use licenses.
Overview of Marijuana Products
CCC regulations require that all marijuana products are manufactured with plants grown by licensed MEs. Marijuana products sold by CCC-licensed MEs are manufactured in a variety of forms. CCC classifies these products using the following four categories.
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Category |
Description |
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Usable marijuana |
These products consist of marijuana plants that have been trimmed, dried, and packaged as a finished product. They are sold in containers as finished marijuana flower or buds and in a pre-rolled form as a single item or in small packs similar to cigarettes. |
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Marijuana resins |
These products are solid marijuana products made by gathering and compressing the cannabinoid-rich1 materials from the marijuana plant. Marijuana resins are commonly known as hashish or kief, and are usually sold by MEs in containers, typically in quantities of one or one-half grams. |
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Marijuana concentrates |
These products are made by using solvents to extract and concentrate compounds from marijuana plants. Concentrate products are created in the form of an oil, paste, wax, or solid material. MEs sell concentrates as a finished product, typically in quantities of one gram or less, or they can be used as an ingredient in other marijuana-infused products. |
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Marijuana-infused products |
These products are made using marijuana resins and concentrates to create numerous marijuana products in edible and inedible forms. Edible forms include baked goods, lozenges, candies, and teas. Inedible forms include ointments, oils, tinctures, and aerosol or electronic cigarettes (and their cartridges). |
Marijuana Production and Testing Processes
Section 4 of Chapter 94G of the General Laws requires all CCC licensees, and CCC itself, to use one statewide seed-to-sale system to account for all marijuana production from seed through harvest and testing through sale. CCC selected Metrc, a third-party electronic tracking and reporting database, to meet this requirement. CCC uses Metrc to track and monitor the following marijuana production processes to ensure compliance with all regulations.
Cultivation
Licensees cultivate marijuana plants in batches from seeds or cuttings from a mother plant. Each batch is assigned a radio-frequency identification (RFID) tag that includes a Metrc identification number to initiate the tracking process. When the batched plants reach a height of about eight inches, the marijuana cultivator grades the batch, selects the well-developed plants for further production, and destroys the remainder. Each selected plant is then assigned a unique RFID tag, while the destroyed product is measured and recorded as destroyed under the original batch’s RFID tag. The selected plants are then moved to growing rooms within the facility. Each growing room has a Metrc location number. The ME records the move in Metrc, which then automatically transfers each plant’s RFID tag to the new growing rooms’ Metrc location number to track inventory. The plants then grow under climate-controlled conditions through the vegetative, flowering, and harvest phases. The vegetative phase is approximately seven weeks, and it is when plants reach most of their mature growing height. The cultivator sets the lighting in the growing room to be on for 16 hours a day to simulate natural growing conditions. The cultivator records the vegetative phase start and end dates and any location changes in Metrc.
Flowering is the phase of growth where signs of flowers appear on the plant stems. Marijuana cultivators induce flowering by reducing the lighting time to 12 hours a day to simulate natural harvest conditions. Cultivators record the flowering phase start and end dates and any location changes in Metrc. Plants are ready for harvest at the end of the flowering phase, which is approximately eight weeks long.
At the end of the flowering phase, cultivators weigh and combine several flowering plants into a single harvest batch. A harvest batch is a collection of marijuana plants that are cultivated and harvested together. The cultivator assigns an RFID tag number to each plant and a total harvest weight to a single harvest batch identification number for inventory control purposes. Harvested plants lose a significant amount of weight because of the post-harvest curing and drying process. The cultivator adjusts the final harvest weight in Metrc (to account for the weight loss), which CCC monitors to ensure that the weight reduction is reasonable by industry standards and no product was diverted or removed within Metrc. The cultivator also adjusts the harvest batch weight in Metrc to account for plant waste materials, such as roots and stems, which are removed from the batch. CCC’s Investigations and Enforcement Unit conducts compliance visits at licensed cultivation facilities to ensure that plant inventories are accurate and complete. Specifically, investigators download the cultivator’s inventory from Metrc to handheld scanners that read plant RFID tags and locations to verify the accuracy of the inventory. CCC’s Investigations and Enforcement Unit immediately investigates any discrepancies at the site. CCC officials told us that during these onsite compliance visits, investigators and compliance officers also check plants for damage or signs of chemical application (e.g., chemical burn marks on plants); review chemical and waste logs; review video footage of licensees’ activities; review employee training, documentation regarding Criminal Offender Record Information checks, and responsible vendor training records; check for pesticides on-site to ensure compliance with the Massachusetts Pesticide Control Act; interview employees when applicable; follow up on complaints when applicable; and check chemical labels for compliance with Section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act.
Testing
Independent testing laboratories (ITLs) are required to test all harvest batches for potency, microbiological contaminants, and pesticide residue. CCC’s protocol for representative sampling in effect during the audit period required cultivators to create one test sample for every 10 pounds of a harvest batch. Metrc tracks the transfer of the test packages by the cultivator or a licensed third-party transporter and records test results. Marijuana cultivators create manifests in Metrc that include information such as weight, types of tests required, and the means of transport (by the cultivator or a licensed third-party transporter) on a barcoded Metrc tracking label that is affixed to the test package.
Upon receipt of each test package, the ITL verifies the manifest information and assigns a laboratory identification number to the package to track and record the test results of each harvest batch. Once the samples pass all required tests, Metrc releases the harvest batch for further processing as a production batch. According to Section 1 of Chapter 94G of the Massachusetts General Laws, a production batch is a “batch of finished plant material, cannabis resin, cannabis concentrate or marijuana-infused product made at the same time, using the same methods, equipment and ingredients.” Under CCC testing protocols, any harvest or production batch that fails the testing can be remediated, such as by reducing moisture content, eliminating bacterial contaminants, or in some cases—such as samples with traces of pesticides—being destroyed.
Packaging and Transfer
After an ITL completes final product testing, the cultivator packages finished products with a label created in Metrc that includes a unique batch number that identifies the production batch associated with the manufacturing, processing, and cultivating of the product.
Using Metrc, the ME manages the transfer of finished products for sale and creates a shipping label and manifest that lists all products contained in the shipment and identifies the CCC-licensed transporter that is accepting the finished products to be transported. MEs may also transport the product itself, using the same process in Metrc. The receiving ME accepts the transfer from the transporter by verifying the manifest information in Metrc. At each transfer, the accepting ME becomes legally responsible for the custody and condition of the finished products. According to CCC officials, the transferred inventory must be reconciled by the accepting ME within eight hours of its receipt of the delivery, including weighing the inventory and counting the number of products in the transferred inventory on camera.
Sale at Marijuana Retailers
After accepting delivery from the transporter, the ME enters the associated Metrc information into its point-of-sale and inventory systems. The point-of-sale system is connected to Metrc and records all sale transactions and adjusts the retailer’s inventory levels as sales and deliveries occur. CCC can use this information to ensure that MEs accurately report retail sales, inventory adjustments, and related information in compliance with all applicable laws and regulations.
Laboratory Testing
CCC licenses ITLs to perform tests in compliance with CCC’s “Protocol for Sampling and Analysis of Finished Medical Marijuana Products and Marijuana-Infused Products for Massachusetts Registered Medical Marijuana Dispensaries.” To obtain a license, an applicant must be accredited by the International Organization for Standardization and the International Electrotechnical Commission under their joint standard for laboratory proficiency (ISO/IEC 17025). To obtain the accreditation, an ITL must be evaluated by third-party examiners on behalf of the International Organization for Standardization to ensure that an ITL is technically proficient and consistently produces precise and accurate test results.
CCC’s testing protocols provide marijuana cultivators, product manufacturers, and ITLs with the required and recommended best practices to sample and test marijuana and products made from marijuana to comply with CCC regulations. The protocols include sampling and testing standards regarding the following types of contaminants that could be introduced to marijuana and products made from marijuana at various stages of cultivation and processing.
- Metals: Metals are naturally occurring elements that enter agricultural products through air, water, and soil. The levels of contamination can vary by geographic location, the plants’ ability to absorb contaminants, and the agricultural and manufacturing processes used to produce finished marijuana products. CCC protocols require testing for arsenic, cadmium, lead, and mercury. Long-term ingestion and/or inhalation of these substances have been associated with several illnesses and diseases, including cancer and disorders of the nervous, digestive, and immune systems.
- Pesticides: Pesticides are manufactured substances that are intended to destroy or repel insects or used to regulate plant growth. Pesticides can be applied in a variety of methods to the growing environment or directly on plants. CCC’s protocols require testing for nine specific pesticides.2 Adverse health effects from pesticide exposure depend on the pesticide and can range from temporary skin and eye irritation to long-term medical conditions, including cancer and reproductive disorders.
- Microbiological contaminants and mycotoxins: Microbiological contaminants are natural chemical toxins produced by living things—including plants, fungi, and bacteria—as a defense against predators, insects, or infestation. Mycotoxins are toxic substances produced from certain molds or fungi present on plants as they are grown or stored. CCC’s protocols require testing for microbiological contaminants and mycotoxins in both unprocessed and processed marijuana material and in marijuana resins extracted from marijuana material with carbon dioxide or solvents. Some microbiological contaminants can potentially cause gastrointestinal distress or liver damage over time. Certain mycotoxins that ITLs are required to test for, such as aflatoxins and ochratoxin A, have been associated with an increased risk of liver cancer and birth defects and could lead to kidney and immune system problems.
- Solvents: Solvents are chemicals used to isolate cannabinoids and other compounds from marijuana material. The process can result in trace amounts of leftover solvents in the final resins or concentrate products. CCC’s protocols list 48 solvents that are allowed in the production of marijuana resins. ITLs test only for the solvent or solvents that the licensee declares were used in the process. Solvents such as ethanol and hexane, allowable for use by CCC’s protocols, have been associated with potential health issues, including dependence, headaches, nausea, and impairment of the central nervous system.
ITLs develop contaminant-testing procedures in compliance with CCC’s testing protocols. ITLs report test results to marijuana cultivators or product manufacturers on a certificate of analysis, which ITLs use to certify that the test results are accurate, complete, and complaint with their own quality control criteria and that the tests were performed with procedures that are accredited by the International Organization for Standardization. Certificates of analysis report three possible test outcomes, as follows.
Test Result
Definition
Limit of Quantitation or Positive Test
This indicates the presence of at least the smallest concentration of a contaminant that can be detected and measured consistently with a high degree of accuracy.
Below Quantitative Level
This indicates that the contaminant or a similar compound has been detected but at concentrations that are too low to be measured with a consistent or reliable degree of accuracy.
Not Detected
This indicates that the contaminant or a similar compound is absent or below a designated cutoff value.
Two ITLs operated in Massachusetts during the audit period to serve the MEs that produced and/or sold recreational marijuana products. During that time, the two ITLs performed 1,512,325 individual tests for potency and contaminants. The average turnaround time—the time between when a test was ordered and when the test results were reported to the ME—was between 4 and 12 days, during most of the audit period.3 A Massachusetts marijuana industry advocacy group we interviewed stated that consistent reporting times are more critical to MEs operating efficiently than relatively short turnaround times and that it was satisfied with ITLs’ performances during the audit period. As of June 15, 2021, four additional ITLs were operating to serve both the medical and recreational markets in Massachusetts, and another 13 ITL license applications were in various stages of the review and approval process, which generally takes about a year to complete.
| Date published: | September 26, 2023 |
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