Does Texas Require Testing for Marijuana and Marijuana Products?
Yes. Per House Bill 1365, medical marijuana and marijuana-infused products in Texas must undergo laboratory testing before dispensing to patients. According to this bill, the Texas Department of Public Safety is authorized to issue licenses to cannabis testing facilities and register their employees, managers, and directors. As stated in Title 37 §12.7(n) of the Texas Administrative Code, cannabis testing facilities cannot be within 1,000 feet of daycare centers or schools (public and private).
Title 37 §12.7 of the Texas Administrative Code stipulates that a sample of each medical marijuana product must be tested in line with Title 16, Part 1107 of the Code of Federal Regulations and the Texas Agricultural Code. In Texas, medical marijuana samples must be tested for:
- Tetrahydrocannabinol levels and cannabidiol levels: According to Title 37 §12.7(q) of the Texas Administrative Code, medical marijuana should not contain more than 0.5% of tetrahydrocannabinol. Also, they should have at least 10% of cannabidiol.
- Pesticide: Title 37 §12.7(c) of the Texas Administrative Code stipulates that only low-risk pesticides exempted under 7 USC §136 of the Federal Insecticide and Rodenticide Act can be used on medical marijuana plants. Also, the active and inactive components of pesticides used in cannabis products must be listed in Title 40 §152.25(f)(1) and §152.25(f)(2) of the Code of Federal Regulations (CFR), respectively. Hence, if the amount of pesticides in a cannabis sample exceeds the allowable limit, that sample fails a laboratory test.
- Levels of residual solvents
- Fungicide and fertilizer levels
- Mould content
- Heavy metals like cadmium, lead, mercury, and arsenic
Does Texas License Independent Marijuana Testing Facilities?
Texas does not have a state-owned cannabis testing facility. However, House Bill 1365 seeks to allow independent medical marijuana facilities to operate in the state. Before the introduction of House Bill 1365 cannabis dispensary organizations conducted laboratory tests on medical marijuana products. As of August 2021, the bill was yet to be signed into law. Consequently, the Texas Department of Public Safety is yet to license any testing facility within the state.
What Accreditations Do Marijuana Testing Facilities Need in Texas?
As stated in House Bill 1365, all medical cannabis testing laboratories in Texas must have an ISO/IEC 17025 accreditation. ISO/IEC 17025 is a company-level accreditation standard for testing laboratories. It is based on guidelines established by the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO). Its most updated version - ISO/IEC 17025:2017, was published in 2017. For Texas’ marijuana testing marijuana facilities to obtain this accreditation, they must meet the following standards:
General requirement standards: Based on this requirement, testing facilities must maintain the confidentiality of all information they create or derive unless required by law. The laboratory must keep all generated data secure and avoid access by unauthorized persons. Also, they must notify clients before sharing their data with third parties. In addition, the testing facilities must maintain a high level of impartiality. They must identify any ongoing activity or relationship resulting in partiality and implement corrective actions to eliminate such risks. The laboratory must also document such interventions.
Structural requirement standards: For medical cannabis testing facilities to adhere to these standards, they must define and document their organizational structure, management, and personnel responsibilities. Also, they must ensure the validity and consistency of results by recording all processes and procedures.
Resource requirement standards: Testing facilities must meet certain personnel, equipment, support, and facility standards.
- Personnel - All internal and external personnel of a marijuana testing facility must be competent and impartial. They must work within the scope of the facility’s organizational system. Also, the laboratory must document each job function and clearly define authorities, duties, and responsibilities. The management must communicate personnel responsibilities through performance reviews and regular meetings and establish records and procedures for choosing, training, and determining employee competency.
- Equipment - The laboratory must have the required equipment for all its activities.
- Facilities and environmental conditions - The testing facility must perform all the required laboratory tests and produce valid results. Also, the environmental conditions of the laboratory, such as ventilation and air quality, must be constantly monitored, controlled, and documented.
- Metrological or measurement traceability - All laboratory test results must be metrologically traceable, allowing the linking of each result to a specific reference.
- Externally sourced services and products - The laboratory must establish procedures for sourcing external products and services. Only products and services that adhere to the facility’s policies can be used. Also, there must be proper documentation of such activities.
Process requirement standards: These standards specify the laboratory’s requirements for several processes:
- Selection, validation, and verification of methods - The testing facility must use standard methods and procedures for validation, selection, and verification procedures.
- Sampling - Laboratories must define their sampling plans and procedures.
- Technical records - The facility’s technical records must contain information detailing reports and results to facilitate the retention of lab results and repetition of tests.
- Handling - Testing facilities must specify their procedures for handling, transporting, receiving, returning, retaining, and storing test items like marijuana samples and equipment.
- Ensuring result validity - Result validity is crucial for ISO/IEC 17025:2017 accredited laboratories. The testing facility must establish its guidelines for monitoring result validity.
- Evaluation of measurement uncertainty - If there are calibration and testing uncertainties, the facility must evaluate such uncertainties to identify the causes.
- Complaints - The laboratory must document its processes for engaging clients and managing their complaints. The process should indicate how the complaints will be received, evaluated, and resolved.
- Information management and data control - The facility must maintain an information management system to ensure that reports and information required for its activities are readily accessible. The laboratory must validate its information management system for functionality and allow personnel to access reference data, instructions, and manuals relevant to the system.
- Non-conforming work - The testing laboratory must establish procedures to implement when results and activities do not conform to agreed client requirements or standard procedures.
- Result reporting - This refers to the various ways the facility presents reports of its activities. It defines the laboratory’s requirements and specifies the standards for report sampling, report amendment, and reporting interpretations, opinions, and statements of conformity. Also, it sets the laboratory’s requirements for test reports and calibration certificates.
Management system options - Medical cannabis testing facilities must have management systems committed to supporting all required standards. There are two management system options - A and B. Under option A, the management system must attend to internal audits, corrective actions, management reviews, record control, improvement, and the control of management system documents.
Under option B, the facility should establish and maintain a management system according to ISO 9001:2015 requirements. Also, the laboratory must fulfill the requirements of management review, management system documentation, and clause 4 to 7 of ISO 17025:2017.
Medical marijuana testing laboratories can achieve ISO 17025:2017 accreditation after accreditation bodies audit the facilities.
How to Get a Marijuana Testing Laboratory License in Texas
As stipulated in House Bill 1365, the Texas Department of Public Safety will consider applicants as eligible for marijuana testing licenses based on the following criteria:
- The applicant’s ability to finance the proposed testing facility and maintain its operations for at least two years from the application date
- The applicant’s ability to secure the personnel and resources for operating the facility
- Accreditation to ISO/IEC 17025 (General Requirements for the Competence of Testing and Calibration Laboratories) standard
- The registration of director, manager, and employee of the entity in line with the provisions of Chapter 487, Subchapter D of the Health and Safety Code
To apply, applicants must take the following steps:
- Complete and submit an application form provided by the Texas Department of Public Safety. If enacted, House Bill 1365 will amend Chapter 487, Section 105 (a) and (b) of the Health and Safety Code. Hence, testing facility applicants must provide their full names and the personal information of each manager, director, and employee of the prospective facility.
- Register each manager, director, or employee in line with Chapter 487, Subchapter D of the Health and Safety Code. To register, they must submit their complete fingerprint scans and pass fingerprint-based criminality background checks.
- Pay their license application fees.
How Much Does a Marijuana Testing Laboratory License Cost in Texas?
The Texas Department of Public Safety will set the application fee for Texas marijuana testing laboratory license once House Bill 1365 becomes law.
Are there Local Regulations for Cannabis Testing Facilities in Texas?
Yes. Municipalities in Texas have regulations for cannabis testing facilities. The local regulations encompass chemical exposure, odor control, air quality, and ventilation standards. House Bill 1365 would amend Chapter 487, Section 201 of the Health and Safety Code, restricting counties and municipalities from adopting ordinances to prohibit cannabis testing facilities. However, according to Title 37 §12.7 of the Texas Administrative Code, prospective cannabis testing facility owners must comply with local ordinances to obtain permission to begin operations. Local fire code officials or local designees of the state fire marshal must inspect facilities to determine that they meet local building, fire, and safety standards. Also, Title 37 §12.7(j) of the Texas Administrative Code stipulates that facilities’ mechanical ventilation must adhere to local standards.
Licensees must comply with all local regulations in all their operations to maintain their licenses. Per Title 37 §12.7(f) of the Texas Administrative Code, they must keep all employee training records on-site and show them to local regulatory officials and local law enforcement officers on request.