Yes. All marijuana and marijuana products sold in Massachusetts must be tested prior to sale. Cannabis has a lengthy process from cultivation to ending up on retail shelves in marijuana stores. There are many possible sources of contamination along the route. Cannabis is a plant that grows in the ground and may be polluted with heavy metals or fertilizers. Heavy metals in the soil may be absorbed by cannabis roots and eventually accumulate in the plant.
In Massachusetts, marijuana or cannabis are required to be rested for environmental media, such as soils, water, and solid growing media. Marijuana is also tested for cannabinoid profile and contaminants as specified by the Cannabis Control Commission, including, but not limited to mold, heavy metals, mildew, plant growth, bacteria, fungi, mycotoxins, terpenes, regulators, and the presence of pesticides. Final ready-to-sell marijuana vaporizer products must also be screened for heavy metals and Vitamin E Acetate (VEA).
The CCC may also, at its discretion, seek further testing where it deems it necessary to protect public safety or health, as determined by the Commission.
Yes. Through the Cannabis Control Commission (CCC), Massachusetts grants licenses to independent testing laboratories to conduct tests on cannabis and cannabis products sold for medical and adult-use in the state.
In accordance with 935 Mass. Reg. 500.160, marijuana and marijuana products may not be sold or marketed for adult use that is not capable of being tested by independent testing laboratories. Marijuana product testing must be conducted by independent testing labs in accordance with procedures developed in accordance with M.G.L. c. 94G, 15 and in the form and manner specified by the Cannabis Control Commission.
There are two types of cannabis testing laboratories in Massachusetts: Independent Testing Laboratory (ITIL) and the Standard Laboratory. An ITIL is a laboratory registered and licensed by the CCC and is:
Currently licensed and legally registered with the Commission according to 935 CMR 500.101, or previously licensed and lawfully registered with the Commission;
A standards laboratory is an organization that would typically qualify as an independent testing laboratory but instead conducts blind tests to validate the findings of an independent testing laboratory at the Commission's request. An independent testing laboratory cannot serve as a standard laboratory in Massachusetts.
Per the CCC Guide on Cannabis Licensing, a testing laboratory licensee may not hold any other type of cannabis license in Massachusetts. No person or entity having direct or indirect control in a testing laboratory may have a different kind of marijuana establishment license or a marijuana treatment center license. No such person may also be granted more than three testing laboratory licenses.
According to 935 CMR 500.132, an independent testing laboratory must be accredited to the most recent International Organization for Standardization (ISO) 17025 standard by a third-party accrediting body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) mutual recognition agreement prior to final licensure. Otherwise, the laboratory must be certified, registered, or accredited by an organization approved by the Massachusetts Cannabis Control Commission (CCC). A laboratory that meets the requirements for granting an independent testing laboratory license mat be licensed as a standard testing laboratory to ensure compliant and consistent testing by the independent testing laboratories.
ISO/IEC 17025 is a quality management system and technical competence standard for laboratory testing and calibration services. It applies to businesses that generate testing and calibration reports. ISO/IEC 17025 accreditation demonstrates that a laboratory has a reliable quality management system in place and can provide testing and calibration findings.
Accredited laboratories conduct tests in accordance with globally accepted standards (ISO/IEC 17025), and the results are validated by a broad range of governmental and regulatory organizations. Accrediting organizations have agreed that accredited members' test results will satisfy the same minimal quality level regardless of the accreditation body and that calibration findings will be regarded as if conducted by the accredited member.
A laboratory's quality management system and technical competence will be evaluated by an appropriate "third-party" certifying organization in order to receive ISO/IEC 17025 certification. Regular audits will also be performed to ensure that the accreditation is maintained. ISO/IEC 17025 certification may be granted only by a certified certifying authority.
Several criteria are considered before issuing an ISO/IEC 17025 certification, including the following:
Following the 2017 amendment to the ISO/IEC 17025 standards, the ISO/IEC 17025 certification process includes five standard requirements.
To begin the process of obtaining a marijuana testing laboratory license in Massachusetts, an applicant must visit the Massachusetts Cannabis Industry Portal and complete all three parts of the license application form. These parts are as follows:
The applicant must provide correct information about the marijuana testing laboratory activities, individuals, and organizations associated with the business and demonstrate an understanding of the relevant regulations regarding testing laboratory operations, locations, and sizes. Each step of the application requires the following information and documentation:
APPLICATION OF INTENT
Required Individuals and Entities: The application must identify those who have direct or indirect control over the cannabis testing laboratory. These persons and entities must meet one or more of the following criteria:
Disclosure of In-State Interests: Applicants must disclose if any of the persons or organizations previously listed as holding or retaining a form of control of the testing laboratory have interests in other Marijuana Establishment (ME) or Marijuana Treatment Center (MTC) license in Massachusetts. The information provided should not be misleading, false, or deceptive in any manner.
Disclosure of Out-of-State Interests: Applicants must provide evidence of any marijuana-related commercial interests that they own or have in other states. An affidavit may be needed to attest to the validity and sincerity of the disclosure, such as bylaws, articles of incorporation, and operating agreement.
Capital Resources: The applicant must disclose the quantities and financing sources available from each individual or organization providing capital to the creation or operation of the testing laboratory. The funds may take the form of loans or equity investments.
The applicant must also show proof of capital, such as a financial institution record dated within 60 days after submitting the application. When a person or organization provides money for a loan, a formal loan agreement is needed.
The person or entity supplying funds must be recognized if they are also a direct or indirect control person or organization. Furthermore, the applicant must prove that any money used to invest in or fund the company was lawfully earned or obtained through an affidavit or notarized document.
Bond or Escrow Account: All applicants must have a bond or escrow account to fund the dismantling and winding down of the marijuana testing laboratory. The funds must be sufficient to cover any outstanding state or local sales taxes, secure the licensee's premises, and destroy the licensee's marijuana and inventory.
Property Identification and Interest Documentation: Each applicant must specify the location of their intended marijuana testing laboratory. Following the identification of the proposed location(s), the applicant must provide proof of property interest, which may include:
Host Community Agreement Certification: A one-page certification from the contracting authority of the host municipality and the applicant is required. Additional information about Host Community Agreements may be found on the Commission's website.
Community Outreach Meeting Attestation and Documentation: The purpose of the Community Outreach Meeting is to educate and enlighten the local community about the planned testing laboratory. The Community Outreach Meeting is highly recommended since it will aid in the development and impact of the Host Community Agreement. Each applicant must have a Community Outreach Meeting in accordance with the Cannabis Control Commission's guidelines.
Plan to Remain Compliant with Local Ordinances: Each applicant must detail their plans for ensuring that the marijuana testing laboratory complies with all local rules, ordinances, and bylaws, including those regulating the sale of adult-use or medical marijuana. Applicants must also provide the following information in their proposal:
Plan to Positively Impact Disproportionately Harmed People: This Plan must be submitted by a testing laboratory license applicant and must be designed to benefit the CCC-identified groups of disproportionately affected people:
BACKGROUND CHECK SECTION
The applicant must identify any relevant persons and entities and any background disclosures and approval documents in this portion of the application. Every person or organization mentioned in the AOI area must be included in the Background Check section. Individuals and organizations will be fingerprinted, and individuals will be subjected to a thorough background investigation.
Background Check Information: The Commission is required to determine the suitability of each individual and organization named on a license application, which is based in part on the results of background checks. Background checks will include, but are not limited to:
Each person and organization listed on the application must disclose any legal proceedings taken against them in Massachusetts or another state. Applicants are not obliged to disclose any convictions that were sealed or erased due to a court order.
Background Authorization Forms: Everyone involved in an application must go through a background check. The Commission's third-party partner performs background checks. The applicant must provide three authorization papers and an unexpired government-issued picture identification card for each person listed on the application in order for the partner to obtain the required information. This package contains the CORI Acknowledgement Form, the Disclosure and Acknowledgement Form, and the Release Authorization Form.
MANAGEMENT AND OPERATIONS PROFILE
This portion of the license applications affords the CCC to gain an insight into the outline of the applicants' plans for operating the marijuana testing laboratory. The information required in this section helps demonstrate that the applicant understands the legal requirements for doing business, including the Commission's rules, and that the applicant has plans that are unique to the license type, location, and size of the establishment.
Business Information, Articles of Organization, and Bylaws: The applicant must demonstrate that the company is registered to do business in the state. Acceptable proofs include:
Certificates of Good Standing: All applicants must provide certifications of good standing from the Massachusetts State Secretary, Department of Revenue, and Department of Unemployment Assistance. All certifications must be dated within 90 days of the license application's submission date.
An applicant must have employees in order to register with the Department of Unemployment Assistance and obtain a certificate of good standing. If an applicant does not have any workers, an attestation to that effect will be accepted in place of a Department of Unemployment Assistance certification of good standing.
Business Plan, Liability Insurance Plan, & Proposed Timeline: All applications must provide insurance policies, projected timelines for attaining operations, and a comprehensive business plan for the operation of the testing laboratory. Revenue and expense forecasts, a business overview, and an operational strategy may all be included in the Plan.
Although insurance policies are not needed until licensing, applicants must show in their plans that once licensed, they will get policies covering general liability and product liability for at least $1 million per occurrence and $2 million in aggregate. Each insurance should have a deductible of no more than $5,000 per incidence.
Summary of Operating Plans, Policies, and Procedures: The applicant must submit plans, policies, and procedures for the operation of the testing laboratory. These papers must be prepared in conformity with the CCC's guidelines and regulations. Among them are the following documents:
Diversity Plan: As part of their Management and Operations Profile, applicants seeking a marijuana testing laboratory license must present a Diversity Plan. Diversity plans must be created in order to enhance equity in the functioning of the institution for people of color, including Black, African American, Hispanic, Latinx, and Indigenous people and women, veterans, people with disabilities, and LGBTQ+ individuals. This Plan differs from the Plan to Help Disproportionately Harmed People.
This Plan must contain the marijuana establishment's goals, programs, and metrics once it has been temporarily licensed. All goals must be quantifiable and measurable.
In addition to the requirements for the Management and Operations Profile set forth in 935 CMR 500.101(1)(c), applicants for a license to operate an Independent Testing Laboratory may include documentation demonstrating compliance with 935 CMR 500.050(7) as part of the Management and Operations Profile packet (a). If the applicant cannot show accreditation prior to provisional licensing, the applicant must do so prior to final licensure.
When the Commission receives a license application, it conducts a thorough examination to verify that it complies with the Commission's rules and regulations. If any portion of the application is found to violate the Commission's regulations, the applicant will be issued a request for further information, also known as an RFI (Request for Information). An RFI notice will include a brief narrative that explains any flaws or non-compliance problems that have been discovered.
Once any mistakes and non-compliance issues have been addressed and the applicant has uploaded all required documents and information, the applicant may resubmit the license application. The new material will be subjected to an expedited examination by the Commission. It will be considered complete if the application is determined to comply with the Commission's rules at this point. If it is not, a second RFI notice will be issued following another round of supplementary evaluation.
When an application is wholly completed, it is placed in a queue for review based on the date and time of submission and whether the application is a priority, expedited, or general application, among other considerations. When the CCC determines that the application is complete, it will inform the applicant of the decision. The notification will include the following information:
The CCC will grant a provisional license provided all of the required information is submitted by the applicant and the relevant government agencies. For more information on marijuana testing laboratory licensure, see the Cannabis Control Commission's Adult-Use of Marijuana Regulations. You can also contact the Cannabis Control Commission at (774) 415-0200 or Commission@CCCMass.com for further inquiries on applying for a testing laboratory license.
An independent testing laboratory license costs $10,000. However, prior to paying a licensing fee, the applicant seeking licensure must pay a $1,500 application fee when submitting the application. A testing laboratory license is renewable every year. The annual license fee is $10,000. Except where expressly permitted, payments are non-refundable and cannot be waived.
Although the Cannabis Control Commission is the principal state agency responsible for regulating, licensing, supervising, and enforcing guidelines for the Massachusetts cannabis industry, municipalities also play a critical role in regulating the industry. Indeed, Massachusetts General Laws Chapter 94G, Section 3 (M.G.L. ch.94G 3) establishes a comprehensive "Local Control" policy framework outlining the methods in which local governments may control cannabis testing among other cannabis activities such as production, sale, and use in their areas.
Section 3 of M.G.L. c. Chapter 94G says specifically that "a city or town may enact ordinances and by-laws imposing reasonable protections on the operation of marijuana businesses, provided that they are not excessively impractical and do not contradict with this chapter or its regulations.".
Ordinances and local laws vary from one municipality to the other. Many of these regulations place strict rules on hours of operation, locations where testing facilities may be situated, chemical exposure, among others. It is recommended that you investigate the specific regulations and ordinances in place in the municipality where you intend to locate your marijuana testing facility.