Arizona Marijuana Testing License

Does Arizona Require Testing for Marijuana and Marijuana Products?

Yes. Senate Bill (SB) 1494, signed into law in June 2019 by Governor Doug Ducey, creates standards for laboratories and mandates registered nonprofit medical marijuana dispensaries, otherwise known as vertically integrated business licensees, to test their marijuana products for harmful levels of potential toxins. This law requires laboratories in Arizona to conduct the following tests on cannabis and cannabis products:

  1. Microbial Contamination

    1. All products must be tested for Salmonella. No remediation is possible for marijuana samples with detectable Salmonella.
    2. All final products must be tested for E.coli before putting them out for sale.
      1. If a products testing is less or equal to 100 CFU/g, it passes
      2. If a product testing is more than 100 CFU/g, that shows that it fails and must be remediated or reprocessed as applicable and retested before selling it
    3. All inhaled products must be:
      1. Tested for Aspergillus flavus, niger, fumigatus, and terreus using molecular methods such as microarrays sequencing, PCR, qPCR, and DNA. Any product less or equal to 1 CFU passes and needs no further testing. However, if the result is more than 1 CFU, laboratories must test the product for mycotoxins. Products testing more than or equal to 20µg/kg (ppm) mycotoxins fails the test and cannot be remediated
      2. Tested for mycotoxins using HPLC, ELISA, or any other federal or international standards. Marijuana products testing showing results more than or equal to 20µg/kg (ppm) mycotoxins fail and cannot be remediated
  2. Heavy Metals

    It is essential to test for heavy metals (arsenic, cadmium, lead, and mercury) in all marijuana final products. Only products with the following parts per million (ppm) values qualify for sale:

    1. Arsenic ≤0.4
    2. Cadmium ≤0.4
    3. Lead ≤1.0
    4. Mercury ≤1.2
  3. Residual Solvents

    Laboratories must test all final extracted products for residual solvents. Only products that conform with the following residual solvent values are eligible for sale:

    1. Acetone ≤1000
    2. Heptanes ≤5000
    3. Acetonitrile ≤410
    4. Hexane ≤290
    5. Benzene ≤2
    6. Isopropyl Acetate ≤5000
    7. Butane ≤5000
    8. Methanol ≤3000
    9. Chloroform ≤60
    10. Pentane ≤5000
    11. Dichloromethane ≤600
    12. 2-Propanol (IPA) ≤5000
    13. Ethanol ≤5000
    14. Propane ≤5000
    15. Ethyl Acetate ≤5000
    16. Toluene ≤890
    17. Ethyl Ether ≤5000
    18. Xylenes ≤2170
  4. Pesticides, Herbicides, Growth Regulators, and Fungicides

    As contained in Table 2 of a Technical Report by the Oregon Health Authority, laboratories must check marijuana final products for fungicides, growth regulators, and pesticides before they are pushed to the market for sale. Products equal to or less than the ppm values listed for each analyte in the table qualifies for sale.

  5. Potency

    In Arizona, it is crucial to test all marijuana products for Delta 9-THC, THC-A, CBD-A, CBD, and any label claims indicative of cannabinoids. The potency of all products must test +/- 20% of label claim or be repacked to meet actual concentration.

Generally, any edible or infused product made from concentrate that previously passed testing in Arizona does not require final testing for heavy metals, solvents, fungicides, pesticides, and growth regulators.

Does Arizona License Independent Marijuana Testing Facilities?

Yes. Following its enactment, SB 1494 required the Arizona Department of Health Services (ADHS) to adopt rules to certify and regulate independent (third-party) laboratories to enable them to test medical marijuana. Furthermore, it stipulated various requirements that these laboratories must meet to obtain certification for marijuana testing. These include:

  • Satisfying all requirements set by ADHS, including reporting and health and safety requirements
  • Having a quality assurance program and standards
  • Having suitable records retention processes
  • Creating procedures to ensure results are accurate, precise, and scientifically valid
  • Having no direct or indirect associations with or interest in a nonprofit medical marijuana dispensary or related medical marijuana business entity or designated caregiver in the state
  • Becoming accredited by a national or international accreditation body or comparable accrediting organization as decided by ADHS
  • Instituting policies and procedures for disposal and reverse distribution of samples

SB 1494 requires marijuana dispensaries to provide patients with test results for those who request. Section 36-2803.01 of the bill also mandates them (dispensaries) to display a sign notifying patients of the right to see certified independent third-party laboratory test results for marijuana and marijuana products. As of September 15, 2021, Arizona has 16 certified independent testing laboratories under the state medical marijuana program. Five of these laboratories have approval for a full scope of the seven test parameters.

What Accreditations Do Marijuana Testing Facilities Need in Arizona?

In Arizona, a marijuana testing laboratory must be accredited by a national or international accreditation organization or a similar accrediting body as determined by the Arizona Department of Health Services (ADHS). Once certified, a laboratory can begin the process of accreditation for the several methods it will use to test marijuana and marijuana products. In one of its recommendations, the Medical Marijuana Testing Advisory Council requires laboratories to produce test reports that are consistent with ISO accreditation.

ISO/IEC 17025 accreditation, issued by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), is used by testing and calibration laboratories. Any laboratory holding ISO/IEC 17025 is considered technically competent and believed to produce accurate test results. Getting the ISO/IEC 17025 requires satisfying specific requirements. ISO/IEC 17025:2017 lists the following requirements for accreditation:

  1. General requirements - The two primary elements under this requirement are confidentiality and impartiality. Confidentiality ensures that laboratories inform customers before making any information public. Information about a customer that a laboratory obtains from other sources must be regarded as confidential. That source must remain confidential to the customer unless otherwise agreed to by the information source. They must not compromise confidentiality for financial, commercial, and other pressures. Also, a laboratory must be committed to neutrality and regularly identify risks to impartiality, including those coming from its activities or relationships (relationships of the laboratory's personnel inclusive).

  2. Structural requirements - This requirement speaks to the structure of a laboratory, its legal status, the identification of the personnel and management, and the availability of people to implement and maintain the integrity of the management system. Typically, laboratory activities must meet the requirements of the standard, its customers, and regulatory bodies. Also, it is responsible for all activities at its permanent location, mobile facilities, customers' facilities, and at sites away from its primary facility. Laboratory personnel must have the authority to do the following:

    1. Implement, maintain, and improve the management system
    2. Determine deviations from the management system or procedures for laboratory activities and take actions to minimize them
    3. Submit reports on the management system
    4. Ensure the effectiveness of laboratory activities

    Under the structural requirements, laboratory management must ensure system integrity. They must also ensure communication on the effectiveness of the management system and customer requirements.

  3. Resources requirements - A laboratory must have the equipment, personnel, and support services required for the effective running of the laboratory. All laboratory personnel must be competent to perform the responsibilities for which they are responsible, act impartially, and stick to the laboratory's management system. They must have access to all equipment needed for the suitable performance of the laboratory activities and which can influence the results. Additionally, before being placed in or returned to service, the laboratory must verify that equipment complies with specified requirements.

  4. Process requirements - A laboratory is required to use the appropriate and acceptable methods and procedures for all its activities. These include handling calibration or test items, reporting results, and ensuring the validity of results. The laboratory must ensure to inform a customer when the method requested is outdated or deemed inappropriate. Before beginning a laboratory activity, any differences between the request and the contract must be resolved.

  5. Management system requirements - Two separate options are required to establish a management system. These are Options A and B. Option A provides a minimum list of requirements a laboratory should meet. These include control of records, improvements, internal audits, management reviews, management system documentation, corrective actions, and control of management system documents. Option B gives a provision of establishing and maintaining a management system in line with ISO 9001 requirements. Option B may provide greater flexibility in implementing ISO/IEC 17025:2017 if a laboratory has already implemented ISO 9001.

How to Get a Marijuana Testing Laboratory License in Arizona

To apply for a laboratory registration certificate in Arizona, an applicant must complete the Initial Laboratory Application using the ADHS Licensing Portal and submit to the Arizona Department of Health Services (ADHS) the following:

  1. An application in an ADHS-provided format that includes:
    1. The physical address of the laboratory
    2. The distance of the laboratory to the closest private school or public school
    3. The following information for the laboratory applying:
      1. The legal name of the laboratory
      2. Type of business organization
      3. Mailing address, telephone number, and e-mail address
    4. The name of the applicant designated to submit the laboratory agent registry identification card applications on behalf of the laboratory
    5. Each owner's name, date, or birth, and residence address
    6. The applicable card or document identifying number
    7. The technical laboratory director's name, date of birth, and residence address
    8. Whether the laboratory agrees to provide additional information on request by the ADHS
    9. An attestation staying that the information provided to the ADHS to apply for a laboratory registration certificate is true and correct
    10. The signatures of the laboratory owner and the technical laboratory director, and the date they appended the signatures
  2. A copy of the organization’s articles of incorporation, articles of organization, or partnership or joint venture documents if it is a business organization (corporation, partnership, limited liability company, joint venture, cooperative), which must include:
    1. The name of the business organization
    2. The type of business organization
    3. The names and titles of the individuals owning the business
  3. Policies that comply with the requirements that contain the following:
    1. Inventory control
    2. A series of custody and sample requirement process
    3. A safe process to transfer the part of a sample remaining after testing to another laboratory with approval for testing issued by the ADHS:
      1. For testing of parameters or analytes that the laboratory receiving the sample from a dispensary is not approved by the ADHS to conduct
      2. For retesting at the request of a dispensary
    4. A records retention process
    5. A system to ensure marijuana or marijuana products testing results are reliable, precise, and scientifically valid before reporting the results
    6. A method for disposing of marijuana or marijuana products that are submitted to the laboratory for testing
    7. Security
  4. For each owner:
    1. A Laboratory Owner Attestation Form signed and dated by the owner that the owner has not been convicted of an excluded felony offense
    2. An attestation signed and dated by the laboratory stating that they do not have a direct or indirect financial or familial relationship with or interest in any Arizona dispensary, related medical marijuana business entity, or management company
    3. An attestation signed and dated by the laboratory owner that the laboratory will not test marijuana or marijuana products for a designated caregiver with whom they have a direct or indirect familial or financial relationship
    4. An attestation signed and dated by the laboratory owner promising not to transfer marijuana to any entity or person individual that is not allowed to possess marijuana under Arizona Revised Statutes (A.R.S) Title 36, Chapter 28.1
    5. A copy of the owner’s:
      1. Arizona identification card
      2. Arizona driver’s license
      3. Arizona registry identification card
      4. Photo page in the owner’s U.S. passport
      5. Arizona driver’s license or identification card and one of the following for the owner:
        1. Birth certificate verifying U.S. citizenship
        2. U.S. Certificate of Citizenship
        3. U.S. Certificate of Naturalization
    6. For the criminal records check by the ADHS authorized in A.R.S. §§ 36-2804.01 and 36-2804.07:
      1. The laboratory owner’s fingerprints on a fingerprint card that includes the following information:
        1. First name, middle initial, if applicable, and the last name
        2. Signature
        3. If not the owner, the signature of the individual physically rolling the owner’s fingerprints
        4. The owner’s residence address
        5. Surname before marriage and any names used previously, if applicable
        6. The owner’s date of birth and place of birth
        7. The owner’s Social Security number
        8. The owner’s citizenship status
        9. The owner’s gender, race, height, hair color, and eye color
      2. If the fingerprints and information were submitted to the ADHS when aplying for a designated caregiver registry identification card, laboratory agent registry identification card or dispensary agent registry identification card within the last six months, the registry identification number on the registry identification card issued to the owner as a result of the application
  5. A sworn declaration signed and dated by the laboratory owners certifying that the laboratory complies with any local zoning restrictions if they exist in the laboratory jurisdiction
  6. A copy of documentation issued to the laboratory by the local jurisdiction authorizing occupation of the building as a laboratory. Such documents include a certificate of occupancy, a special use permit, or a conditional use permit
  7. A building plan of the structure where the laboratory is located showing the:
    1. Layout and dimensions of each room
    2. Name and function of each room
    3. Location and plan of refrigerated sections or freezer rooms
    4. Location of each safety shower, sink, other water supply, or plumbing fixture
    5. Location of fixed or mobile equipment that requires dedicated electrical, water, vacuum, gas, or other building systems
    6. Fire ratings of the materials used for doors, ceilings, walls, and floors of rooms used to store flammable substances
    7. Location of each fire protection device
    8. The layout of heating, air conditioning, exhaust, and ventilation systems
    9. Location of security mechanisms or equipment to protect from the diversion of marijuana or marijuana products
    10. Means of exit
  8. If applicable, the laboratory’s Transaction Privilege Tax Number issued by the Arizona Department of Revenue
  9. A site plan of the laboratory, which must show bildings, streets, parking areas, property lines of the contiguous premises, outdoor areas if applicable, fences, security features, fire hydrants if applicable, and access to water channels
  10. Documentation of accreditation of the location for which the applicant is applying for a laboratory registration certificate
  11. The applicable fee for applying for a laboratory registration certificate.

Within 72 hours after an applicant receives a laboratory registration certificate following their application, the laboratory owner must apply for a laboratory agent registry identification card for each laboratory agent, including a technical laboratory director. Any change in location of the laboratory’s physical address or ownership requires submitting a new application. Generally, a separate laboratory registration certificate is required for each noncontiguous portion of a laboratory.

After the initial laboratory application, an applicant must obtain approval for testing from the ADHS. To get approval for marijuana testing, an applicant must submit the following to the ADHS at least 60 days before the initial laboratory registration certificate for the laboratory expires:

  1. An application in an ADHS-provided format that includes:
    1. The laboratory’s name and registry identification number of the laboratory
    2. The physical address of the laboratory
    3. The name of the applicant
    4. The name of the technical laboratory director.
    5. An attestation that the information the laboratory provided to the ADHS to get approval for testing is true and accurate
    6. The signatures of the laboratory owner and the technical laboratory director, and the date each signed
    7. The laboratory’s proposed hours of operation
    8. Whether the laboratory agrees to permit the ADHS to submit supplemental requests for information
    9. For each parameter for which the applicant requests approval for testing:
      1. The analyte to be tested for
      2. The instruments and equipment that will be used for testing
      3. The software that the laboratory intends to use for instrument control and data reduction interpretation
    10. Whether the marijuana laboratory is set for an inspection by the ADHS, and if not, the date it will be ready
  2. If different from the building plan submitted during the initial application, a building plan of the structure where the laboratory is located showing the following:
    1. Name and function of each room
    2. Layout and dimensions of each room
    3. Fire ratings of the materials used for doors, walls, ceilings, and floors of rooms used to store flammable substances
    4. Location of each fire protection device
    5. Location of each sink, safety shower, other water supply, or plumbing fixture
    6. Location of fixed or movable equipment and instruments that require dedicated electrical, water, vacuum, gas, or other building systems
    7. Location of security equipment to protect from the diversion of marijuana or marijuana products
    8. The layout of heating, air conditioning, exhaust, and ventilation systems
    9. Location and layout of refrigerated rooms or freezer rooms
    10. Means of exit
  3. For each parameter and analyte listed by the applicant:
    1. The limit of quantitation
    2. A copy of a proficiency testing report or accuracy testing documentation
    3. A copy of the standard operating procedure
  4. Policies and procedures that comply with the requirements in this Chapter including:
    1. A quality assurance program and standards
    2. A process to compile testing results into a single laboratory report to be provided to a dispensary

The overall time frame of applying for a laboratory registration certificate in Arizona is 90 working days (30 days for administrative completeness and 60 days for substantive review). It also takes 90 business days to get approval for testing after the initial application (30 days for administrative completeness and 60 for substantive review). A laboratory registration certificate is valid for two years after the date of issuance by the ADHS. Typically, the approval for testing expires at the same time as the laboratory registration certificate associated with it.

How Much Does a Marijuana Testing Laboratory License Cost in Arizona?

To get certified as a marijuana testing laboratory in Arizona, an applicant must pay a non-refundable registration fee of $5,000. The cost of renewing this registration is $1,000. A laboratory agent is required to pay a $500 fee for a registry identification card and the same amount for renewal.

Are there Local Regulations for Cannabis Testing Facilities in Arizona?

Yes, depending on the proposed municipality for a cannabis testing facility. Several Arizona cities moved to ban recreational marijuana dispensaries shortly after the passage of the Smart and Safe Act unless a marijuana license holder is a dual licensee. The Smart and Safe Act allows a dual licensee to operate both as a recreational marijuana establishment and a medical marijuana establishment. The ban by some of these cities on recreational marijuana was not limited to dispensaries. They also outlawed marijuana testing facilities

Many municipalities seek to protect public health, safety, and welfare by enacting zoning regulations to limit the number of marijuana establishments, including cannabis testing facilities in their locality. Hence, it is essential for anyone or entity looking to establish and operate a marijuana testing facility in any jurisdiction in Arizona to find out their local regulations on marijuana and obtain necessary local approvals where possible.

Arizona Marijuana Testing License