Does Illinois Require Testing for Marijuana and Marijuana Products?
Illinois requires the testing of all marijuana and marijuana products produced and retailed in the state. Illinois has a medical cannabis law, the Compassionate Use of Medical Cannabis Act, and an adult-use law, the Cannabis Regulation and Tax Act). Both cannabis laws require laboratory testing of cannabis products. Also, the Illinois Administrative Code mandates that before the packaging and processing of any cannabis or cannabis-infused products, each batch must be made available for testing. An employee of a state-approved laboratory shall be allowed to select random samples of the product for an active ingredient analysis. The samples will also be tested for:
- Microbiological contaminants
- Pesticide active ingredients
- Residual solvents
- Heavy metals
Does Illinois License Independent Marijuana Testing Facilities?
Any laboratory accredited by the Illinois Environmental Lab Accreditation Program (ELAP) or the Department of Public Health can test cannabis products. The laboratory will need to apply for a permit to test cannabis and cannabis-infused products from the Department of Agriculture (IDOA). The IDOA also issues permits to laboratories that are accredited by any private accrediting organization.
To be eligible to test cannabis and cannabis-infused products in Illinois, the laboratory must:
- not be owned by persons who have direct or indirect interests in the cannabis industry in the state.
- have in employment at least one individual that will be responsible for the testing of cannabis, who possesses at least:
- Master’s level degree in any chemical or biological science and at least two years post-degree experience in a lab facility; or
- Bachelor’s level degree in a biological or chemical science with at least four years post-degree experience in a laboratory
- ensure the IDOA receives a copy of the most recent annual inspection report accrediting the laboratory and every subsequent report after that.
Currently, the Department of Agriculture has approved the following laboratory facilities for the testing of cannabis and cannabis-infused products in Illinois;
- ACT Laboratories, Inc.
- Advanced Herbal Analytics, LLC
- ARDL, Inc
- CanMed Labs, LLC
- Cogent Lab, LLC
- Deibel Bioscience of Illinois, LLC
- Grace Analytical Laboratory, Inc
- ICR Labs, Inc.
- LK Pure Labs (Monticello)
- LK Pure Labs (Sparta)
- MS Bioanalytical, LLC
- Origo Labs, LLC
- QC CLB IV, Inc.
- Unitech Laboratories of Illinois
What Accreditations Do Marijuana Testing Facilities Need in Illinois?
The State of Illinois requires that all laboratories approved to test cannabis and cannabis-infused products possess an ISO/IEC 17025 accreditation. This is a company-level accreditation based on a standard established by the ISO titled "General requirements for the competence of testing and calibration laboratories.” This accreditation certifies that the laboratory has met the management and technical standards of ISO 17025 and is competent to operate and generate valid results. The standard is governed by the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC).
ISO/IEC 17025:2017 is the current version of this standard, published in 2017. To comply with the requirements of ISO/IEC 17025:2017, the laboratory facility must meet a defined set of criteria. These are:
General Requirement Standards: The requirements for this standard are:
- Impartiality - There must be no conflicts of interest. The laboratory must identify risks to impartiality from activities and relationships on an ongoing basis. Corrective actions must be implemented to eliminate risks, which they must document.
- Confidentiality - The laboratory is responsible for the management of all data created from its activities. Before sharing a customer’s information with a third party, the customer must be given prior notice. All data created or derived is considered proprietary and confidential unless required by law.
Structural Requirement Standards: To comply with these standards, the laboratory facility must document and define the following:
- Organizational structure
- Management and their responsibilities
- Personnel responsibilities
- Laboratory activities
To ensure consistency and validity of results, they must document all procedures and processes. Only laboratory equipment that will be utilized in the facility can be included in the scope of accreditation.
Resource Requirement Standards: These include:
- General resource standards - These concern personnel, facilities, equipment, systems, and support services. Competence and impartiality are required of all internal and external personnel.
- Personnel - All personnel must work within the structure of the laboratory organizational system. Each job function must be appropriately documented, and duties, responsibilities, and authorities, communicated by management via regular meetings and performance reviews. Established procedures and records must be in place for determining employee competency requirements, choosing, and training personnel.
- Facilities and Environmental Conditions - Facilities must be capable of performing all laboratory activities without compromising the validity of test results. Laboratory conditions must be documented, controlled, monitored, and recorded at all times.
- Equipment - Proper equipment for the performance of laboratory activities must be readily available.
- Metrological Traceability - The laboratory must establish and maintain metrological traceability of their results.
- Externally provided products and services - Only compliant externally provided products and services can be used, and the lab must have procedures for establishing this and maintaining records.
Process Requirement Standards: These define the requirements for the following processes:
- Review of requests, tenders, and contracts - The laboratory must have defined processes for assessing proposals, tenders, and contracts.
- Selection, verification, and validation of methods - The laboratory must use the appropriate techniques and procedures for these processes.
- Sampling - The laboratory must have a defined sampling plan and method.
- Handling - The laboratory must have defined procedures for transporting, receipt, handling, storage, retention, and disposal or return of test items.
- Technical records - All laboratory technical records must contain results, a report, and information to facilitate the retention of results and repetition of lab activities.
- Evaluation of measurement uncertainty - The laboratory facility must evaluate measurement and testing uncertainties and identify the contributions to these uncertainties.
- Ensuring the validity of results - The laboratory facility must have established procedures for monitoring the validity of results, which is a top priority of ISO/IEC 17025:2017 accredited laboratories.
- Reporting of Results - This covers the presentation of the different types of reports of the results of laboratory activities. It defines the following:
- Common requirements
- Specific requirements for test reports
- Specific requirements for calibration certificates
- Requirements for report sampling
- Requirements for reporting statements of conformity
- Requirements for reporting opinions and interpretations
- Requirements for amending reports
- Complaints - The laboratory must have a documented process for managing customer complaints. This process must encompass the receipt, evaluation, and complaints resolution.
- Non-conforming Work - The laboratory must have procedures in place that must be implemented if activities and results do not conform to standard procedures or agreed customer requirements.
- Control of Data and Information Management - The laboratory must ensure adequate access to data and information required for its activities. The information management system must be validated for functionality, and personnel must have access to manuals, instructions, and reference data relevant to the management system.
Management System Options: This establishes that the laboratory facility must implement a management system capable of supporting and demonstrating a commitment to all the required standards. This management system must follow either Option A or B.
- Option A - The management system under this option must attend to the following:
- Management system documentation
- Control of management system documents
- Control of records
- Actions to address risks and opportunities
- Corrective actions
- Internal audits
- Management reviews
- Option B - This states that the laboratory facility management system is compliant if:
- It has established and maintained a management system compliant with the requirements of ISO 9001:2015
- The laboratory facility is capable of supporting and demonstrating the fulfillment of the provisions of ISO 17025:2017
- The laboratory facility has fulfilled the requirements of the management system documentation and management review.
How to Get a Marijuana Testing Laboratory License in Illinois
Laboratories seeking approval to test cannabis and cannabis-infused products should complete and submit the approval form to the Department of Agriculture. Applicants should send a paper copy and an electronic copy on a USB drive, containing the same information, to:
Illinois Department of Agriculture
ATTN: Division of Cannabis Regulation
Springfield, IL 62794
How Much Does a Marijuana Testing Laboratory License Cost in Illinois?
The Compassionate Use of Medical Cannabis Administrative Rules and the Cannabis Regulation and Tax Act did not propose a fee for approval of a marijuana testing license in Illinois. Any laboratory that applies for approval must be established and possess ISO/IEC 17025 certification, having certified its processes by an independent organization. The laboratory must attach a list of its analytical methods and its most recent inspection report that validate these methods. During their application, the laboratory is required to attest to:
- Its impartiality
- Its competence and the experience and training of its staff
- Its familiarity with the codes governing the handling, testing, and analyzing of cannabis
Are there Local Regulations for Cannabis Testing Facilities in Illinois?
The approval to test cannabis in Illinois is only given to laboratories with proper and up-to-date accreditation from the appropriate regulatory authority. Generally, laboratories with these accreditations have already complied with all the state and local regulations regarding air quality, odor control, chemical exposure, and ventilation requirements. Specifically, Illinois does not have local regulations that must be met to get approval for a marijuana testing facility.