Does Ohio Require Testing for Marijuana and Marijuana Products?
Yes. Per House Bill 523, laboratory tests must be carried out on medical marijuana and marijuana-infused products before they are sold at licensed dispensaries. Medical marijuana tests are essential to ensure uniformity in the quality of cannabis produced and dispensed to patients.
Section 3796.21 of the Ohio Revised Code authorizes testing laboratories to collect medical marijuana samples from licensed cultivators, manufacturers, and dispensaries for testing. According to HB 523, the Ohio Department of Commerce must establish the testing standards and procedures for medical marijuana samples. Also, the Department is authorized to:
- Determine when lab tests will be performed on cannabis samples
- Specify the guidelines for laboratories to provide test results
- Specify the minimum quantity of medical marijuana to be tested. According to Rule 3796:4-2-04 of the Ohio Administrative Code, cannabis laboratories must test at least:
- 0.5% of cannabis plant materials sold to licensed medical dispensaries
- 0.5% of plant materials sold to licensed processors
- One unit of packaged cannabis products obtained from processors for sale at licensed dispensaries
- 0.5% of cannabis-derived ingredients (including extracts) used to manufacture medical cannabis products
Laboratories test marijuana samples for contaminants, potency, and homogeneity and prepare test reports. Per the provisions of Rule 3796:4-2-04 of the Ohio Administrative Code, laboratory testing analysis is carried out on medical marijuana samples to determine their:
- Moisture content
- Water activity
- Foreign matter
- Cannabinoid potency including the levels of the following components:
- Cannabidiol (CBD)
- Cannabinol (CBN)
- Cannabidiolic acid (CBDA)
- Delta-9-tetrahydrocannabinolic acid (THCA)
- Delta-9-tetrahydrocannabinol (THC): According to Section 3796.06 of the Ohio Revised Code, marijuana plant materials should not contain more than 35% THC. Also, cannabis extracts should not have more than 70% of THC.
- Pesticide and fertilizer residue: Medical marijuana samples pass pesticide and fertilizer residue analysis if they fulfill Title 40 Part 180 of the C.F.R standards. If the lab detects any pesticide residue not approved in 40 CFR 180, that sample fails the lab test even if a negligible amount of the residue is detected.
- Heavy metal contamination: The limits for heavy metals in medical marijuana samples are a maximum of 0.09, 0.14, 0.29, and 0.29 micrograms of cadmium, arsenic, mercury, and lead, respectively, per kilogram of the sample.
- Mycotoxin contamination - Medical marijuana samples pass mycotoxin contamination analysis if the total amounts of aflatoxin G2, G1, B1, and B2 do not exceed 20 micrograms per kilogram of the sample. Also, the ochratoxin A content must not exceed 20 micrograms per kilogram of the sample.
- Microbial contamination - For a sample to pass microbial contamination analysis, it must fulfill the cannabis inflorescence, quality control, identity, and analysis standards of the 2014 American Herbal Pharmacopoeia monograph.
Does Ohio License Independent Marijuana Testing Facilities?
Yes. Ohio issues licenses to independent cannabis testing facilities. There is no state-owned laboratory that tests medical marijuana in Ohio. However, the Ohio Department of Commerce licenses both private labs and universities that meet its requirements and does not limit the number of testing laboratories it permits. As of 2023, the Department had licensed (issued certificates of operation) eight medical marijuana testing laboratories in Ohio while another two laboratories have provisional licenses.
What Accreditations Do Marijuana Testing Facilities Need in Ohio?
As stipulated in Rule 3796:4-1-02 of the Ohio Administrative Code, medical marijuana testing facilities must obtain and maintain ISO/IEC 17025 (General Requirements for the Competence of Testing and Calibration Laboratories) accreditation. The International Organization for Standardization (ISO), in collaboration with the International Electrotechnical Commission (IEC), established a universal standardization system called ISO/IEC 17025. ISO/IEC 17025 is a model for testing laboratories designed to produce quality management, testing methodology, equipment, employee competency, calibration, and test results in laboratories. Laboratories obtain ISO/IEC 17025 certification to establish their commitment to generating valid laboratory test results.
The steps required for ISO/IEC 17025 accreditation are:
- Learn about the ISO/IEC standards and determine the right one for the laboratory to be certified.
- Conduct a 17025 gap analysis of the laboratory to determine areas that need a change in the existing QMS (Quality Management System). An independent consultant can perform this analysis.
- Create an ISO/IEC 17025 implementation plan
- Train laboratory employees to observe the implementation plan
- Design a new ISO/IEC 17025 QMS and document it in the laboratory manual
- Use the new ISO/IEC 17025 QMS - Ensure that all employees work with the procedures, document, and improve the system for at least three months
- Conduct an internal audit to determine if the new QMS is working and find ways to improve it
- Achieve accreditation by selecting an ISO/IEC 17025 accreditation body to audit the facility
How to Get a Marijuana Testing Laboratory License in Ohio
To get marijuana testing laboratory licenses in Ohio, prospective licensees must submit their applications to the Department of Commerce. The Department of Commerce is the state agency that oversees cannabis testing laboratories and issues licenses to applicants. Rule 3796:4-1-02 of the Ohio Administrative Code authorizes the Department to establish open periods for testing facility license applications and announce the dates and times to the public in advance. Nevertheless, the Director of the Department may cancel or amend the application notice. However, they must publish the changes through the same medium as the original announcement.
Prospective licensees must submit the following when applying for provisional testing licenses in Ohio:
- A business plan
- Details of any previous convictions from administrative or judicial proceedings that caused the applicant to be penalized when operating a business
- The facility's location area map showing the surroundings. The map should prove that the prospective facility is at least 500 feet away from the boundaries of prohibited public spaces such as public parks, schools, and public libraries.
- A copy of any medical marijuana facility (cultivation, production, testing, or dispensing) license the applicant holds from another state. The applicant must issue a statement permitting the Department of Commerce to contact the former licensing agency for further details. Applicants must submit copies of documents indicating any suspension, fines, license revocation, or sanction by that licensing agency (if any).
- Documents showing that the testing facility will comply with local government ordinances concerning safety and building standards. Applicants must obtain approval from the building departments of county or city authorities where they intend to establish their facilities.
- Operations plan - A testing facility operations plan indicates the procedures and policies that the prospective licensee will implement for the safe and standard analytical testing of medical cannabis. The plan must comply with ISO/IEC 17025 (General Requirements for the Competence of Testing and Calibration Laboratories) standards. It must include the testing facility specifications (as provided in Chapter 3796 of the Ohio Revised Code), proposed analysis techniques, and list all analytical services the prospective facility will offer. Also, it should state the facility’s procedures and implementation standards for laboratory testing of medical cannabis and medical cannabis products. The implementation standards should allow ISO/IEC 17025 standard accreditation within two years of provisional testing license issuance. Other things to include here are the facility's inventory tracking system, waste disposal, employment and staffing training plans, and OSHA (Occupational Safety and Health Administration) protocols.
- Financial plan - The financial plan for a testing facility should include the facility's funding sources and state the identities of every association, individual, or corporation with shares in the proposed facility. It should also break down the estimated cost implications of establishing the facility.
- A statement from a certified public accountant in Ohio verifying that the applicant has at least $250,000 to operate the proposed facility
- Evidence that the applicant will comply with the testing laboratory financial responsibility requirements of Rule 3796:4-1-05 of the Ohio Administrative Code
- Criminal history records of the applicant, board members, and administrator to oversee the facility's daily operations. The records should be from the Federal Bureau of Investigation (FBI) and Ohio Bureau of Criminal Identification and Investigation.
- Ownership or lease documents of the property on which the testing facility will be located. The documents must not have any use restriction that prevents the applicant from operating a cannabis testing facility in line with Chapter 3796 of the Ohio Revised Code.
- State and federal tax payment records of the applicant and any other person with up to 1% ownership in the business. If an applicant operates any business in another state, they must show their tax records from that jurisdiction.
- Security plan - This should state the proposed facility's procedures and guidelines to protect employees and prevent loss, theft, and diversion of cannabis from the testing facility. The security plan should include transportation guidelines, record-keeping policies, and testing laboratory security requirements as stipulated in Rule 3796:4-2-07 of the Ohio Administrative Code.
- The testing facility plot plan, indicating the various sections of the laboratory, including those with restricted access. Prospective licensees must show the interior of buildings that already existed before application and any plans to modify them. Alternatively, applicants intending to construct new buildings for their laboratories must submit an architectural drawing of the building.
- A $2,000 application fee (non-refundable), as stipulated in Rule 3796:5-1-01 of the Ohio Administrative Code. The application fee should be paid via money order or check, payable to the Ohio Treasurer of State.
In Ohio, marijuana testing license applicants should submit their applications and applicable fees in person or send a representative to the Medical Marijuana Control Program of the Department of Commerce at:
Ohio Department of Commerce
Vern Riffe Center
77 South High Street, 23rd Floor
Columbus, OH 43215
Persons interested in applying for marijuana testing licenses can inquire further from the Department of Commerce via email. Inquirers should use ''Testing Laboratory Provisional Licensing Application'' as the subject of their emails.
How Much Does a Marijuana Testing Laboratory License Cost in Ohio?
According to the provisions of Rule 3796:5-1-01 of the Ohio Administrative Code, the costs of obtaining medical marijuana testing laboratory licenses in Ohio are:
- $2,000 non-refundable license application fee
- $18,000 non-refundable certificate of operation fee
- $ 20,000 non-refundable certificate of operation annual renewal fee
- $100 for employee identification cards, to be renewed every two years at a $100 fee
Are there Local Regulations for Cannabis Testing Facilities in Ohio?
Yes. Testing facility applicants must fulfill specific local regulatory requirements before they can secure their licenses. According to Rule 3796:4-1-02 of the Ohio Administrative Code, applicants must obtain certain documents from the local governments of cities or counties where they will locate their facilities. In Ohio, marijuana testing license applicants must comply with all local authorities' fire, safety, building, and zoning regulations. Usually, local laws consider ventilation, air control, chemical exposure, and other standards before approving the establishment of medical cannabis testing facilities.
Furthermore, licensees must maintain the local standards even after commencing operations on their facilities. The Department of Commerce is authorized to work with local authorities during routine facility inspections to ensure adherence. Licensees who violate their local ordinances risk suspension or revocation of their medical marijuana testing licenses.