Chapter 08. Laboratory Registration and Operations

“Accreditation body” means a nonprofit, impartial organization that requires conformance to 17025 ISO/IEC requirements and is a signatory to the international laboratory accreditation cooperation (ILAC) mutual recognition arrangement for testing.

“Cannabis industry” means all cannabis registrants, licensees, and their agents in Maryland.

Submit a completed independent laboratory registration form;

Pay the registration fee specified in COMAR 14.17.21;

Submit a copy of the certificate of accreditation accompanied by the scope of accreditation; and

Submit the name, address, date of birth, and Social Security Number or Individual Taxpayer Identification Number of each independent testing laboratory employee and a copy of the application form completed by each independent testing laboratory employee.

A copy of the contract with the accreditation body with which it is applying to become accredited and a copy of the proposed scope of the accreditation;

Evidence the independent testing laboratory has been accredited by the accreditation body in another jurisdiction; and

All other required components listed in §B of this regulation.

The term of the registration may not exceed the term of the provisional registration; and

No additional registration fee need be paid for that term.

Follow the methodologies, ranges and parameters which are contained in the scope of the accreditation for testing cannabis or cannabis products;

Establish standard operating procedures and method validation or verification, if applicable, for testing that are approved by the accrediting body and the Administration;

Establish and follow written procedures for verifying the experience and education of laboratory employees;

Before an independent testing laboratory employee works or volunteers for the independent testing laboratory, register the employee with the Administration;

Upon termination of the independent testing laboratory’s association with a registered independent testing laboratory employee:

Notify the Administration within 1 business day after the independent testing laboratory obtains notice of any kind that its accreditation has been denied, suspended, or revoked;

Implement the testing requirements established in Regulation .05 of this chapter and identified in the Administration’s Technical Authority for cannabis testing;

Maintain a continuous or motion-activated video surveillance recording system that:

Store and retain all recordings of security video surveillance in a format that can be easily accessed for investigational purposes for a minimum of 90 calendar days;

Make any security video surveillance recording available to the Administration or law enforcement agency for just cause as requested within 48 hours;

Maintain a log of all visitors to the premises for 2 years; and

Conspicuously display a copy of its laboratory registration at the registered premises.

Failure to provide the Administration with any video surveillance recording within 48 hours of a request from the Administration is a violation of COMAR 14.17.14.04.

Each day of recording within the minimum timeframe stated in §A(9) of this regulation that a licensee fails to provide to the Administration constitutes a separate violation.

A registration renewal form completed in the manner specified by the Administration;

Payment of the registration fee specified in COMAR 14.17.21; and

Submission of copies of the most recent:

Establish and follow statistically valid sampling methods to obtain samples from licensees;

Adopt standard operating procedures that are approved by the Administration to test cannabis, cannabis concentrate, and any other product that contains more than 0.5 milligrams of THC per serving and 2.5 milligrams of THC per package;

Perform sampling, testing, and analysis of cannabis and cannabis products in accordance with the Administration’s Technical Authority;

In the event a test result is outside action limits:

Issue to the licensee a certificate of analysis for each batch or lot, with supporting data upon request, to report concentrations of compounds, presences of contaminants, and whether the batch or lot is within action limits for certain characteristics, as required by the Technical Authority; and

After the analysis is complete, weigh, document, and destroy all green waste in accordance with a standard operating procedure approved by the Administration.

Has been registered by the Administration;

Is independent from any entity licensed under Alcoholic Beverages and Cannabis Article, §36-401, Annotated Code of Maryland, to grow, process, or dispense cannabis;

Is accredited by an accreditation body or has a provisional registration from the Administration;

Has established standard operating procedures that provide for adequate chain of custody controls for samples transferred to the independent testing laboratory for testing, which are approved by the Administration; and

Enters timely and accurate data into the seed-to-sale tracking system that identifies and tracks samples.

Provide materials to the State Cannabis Testing Laboratory to conduct the activities under Regulation .07B of this chapter; and

As part of a licensee inspection, analyze samples and provide a written report to the Administration.

With oversight by at least one independent testing laboratory employee registered with the Administration; and

Using a vehicle that meets the criteria specified in COMAR 14.17.09.03.

Prepare, conduct, and analyze proficiency testing events for independent testing laboratories registered under this chapter;

Develop cannabis testing methodologies;

Conduct compliance testing on cannabis samples;

Establish and verify standard operating procedures for independent testing laboratories;

Develop and facilitate quality assurance and compliance controls for micro growers and micro processors;

Remediate problems with registered independent testing laboratories and recommend Administration sanctions; and

Test products for adverse event reporting, research, and other purposes deemed necessary by the Administration, including:

The State Cannabis Testing Laboratory may establish pilot programs for the purposes of:

As part of a pilot program established under this section, the Administration may waive, reduce, or amend existing testing standards.

Participation in a pilot program will be determined by the Administration, in a manner prescribed by the Administration.