South Dakota Marijuana Testing License

Does South Dakota Require Testing for Marijuana and Marijuana Products?

South Dakota requires product testing for all marijuana and marijuana products before they are made available for public consumption. Article 44:90:07:02 (5) of the South Dakota Medical Cannabis Draft Rules mandates cannabis manufacturing establishments to ensure that their products pass all the laboratory tests mandated by the South Dakota Department of Health. This rule applies to products manufactured using cannabis, cannabis concentrates, or extracts of cannabis.

The tests required to be conducted on all marijuana and marijuana products are contaminant tests such as:

• Test for residual pesticide: Medical marijuana or medical marijuana products containing residual pesticides in concentrations exceeding the permitted action levels shall be considered non-useable. However, the synthetic chemical agents in pesticides approved for use by the South Dakota Department of Health are:

1. Auxin
2. Azadirachtin
3. Capric acid
4. Caprylic acid
5. Caprylic acid
6. Copper octanoate
7. Cytokinins
8. Diatomaceous earth
9. Gibberellic acid
10. Horticultural oils
11. Hydrogen peroxide
12. Indole-3-butyric acid
13. Insecticidal soaps
14. Iron phosphate
15. Methoprene
16. Peroxyacetic acid
17. Petroleum oils
18. Phosphorous acid, including salts thereof;
19. Potassium bicarbonate
20. Potassium silicate
21. Potassium sorbate
22. Sodium bicarbonate
23. Sodium ferric EDTA
24. Sodium lauryl sulfate; and
25. Sulfur

• Test for residual solvents: Medical marijuana products containing detectable levels of any residual solvent other than glycol, glycerin, ethanol, propylene, or cooking oil shall be considered non-useable.
• Test for fungal presence: The presence of molds and yeasts in a medical marijuana product may be permitted if they do not exceed 10⁴ cfu/g each. The presence of Aspergillus fungi like Aspergillus fumigatus, Aspergillus flavus, Aspergillus terreus, and Aspergillus niger may also be permitted if they do not exceed 1cfu/g each. The presence of mycotoxins in medical marijuana products may be permitted, provided they do not exceed the following concentrations for each of them.

• Test for bacteria: The concentrations of bacteria detected in any medical marijuana product in South Dakota should not exceed the following levels.

• Test for heavy metals: The presence of common heavy metals in medical cannabis may be permitted if they do not exceed the following maximum concentrations stipulated for each of them:

Does South Dakota License Independent Marijuana Testing Facilities?

South Dakota licenses independent medical marijuana testing laboratories to test marijuana products and ascertain their safety for public consumption. There is no government agency assigned to test marijuana products in the state. However, the South Dakota Department of Health regulates marijuana testing. As of early 2024, the state has two independent medical marijuana laboratories. However, one of them is only meant for confirmatory and law enforcement testing.

What Accreditations Do Marijuana Testing Facilities Need in South Dakota?

Article 44:90:06:01 (1) of the Revised Rules for Medical Cannabis in South Dakota requires licensed medical marijuana testing laboratories in the state to obtain an ISO/IEC 17025 accreditation. The scope of the ISO/IEC 17025 accreditation obtained by the medical marijuana testing facilities should include all the analytical tests that the facility performs. The South Dakota Department of Health requires licensed medical marijuana testing facilities to complete their ISO/IEC 17025 accreditation within 18 months from the date they obtain their license. Medical marijuana testing facilities that do not obtain their accreditation within 18 months of licensure risk losing their license.

ISO/IEC accreditation indicates an official acknowledgment of the capacity of a medical marijuana testing facility to produce reliable laboratory test results. The accreditation is granted by the American National Standards Institute (ANSI) National Accreditation Board. The board has some set standards that marijuana testing laboratories must meet to demonstrate conformance to organizational standards; some of which are:

• The medical marijuana testing laboratory must submit a document showing how the marijuana testing laboratory plans to perform representative sampling for each activity mentioned within the scope of the accreditation. The document should cover the processes of the activities in the testing laboratory for a period not less than three years. It should also contain an evaluation of the risks associated with laboratory procedures, detailing the facility’s mechanisms to manage the risks
• The medical marijuana testing laboratory must assure the ANSI National Accreditation Board that they will investigate any test result that falls outside of the prescribed performance range. Some of the actions expected of a medical marijuana testing facility when test results fall outside of the prescribed range are:
  • The medical marijuana testing facility shall immediately notify the ANSI National Accreditation Board by sending an email using the ANAB FM 2830 Client Notification form
  • The medical marijuana testing facility shall produce a documented time frame to take corrective actions regarding the unsatisfactory result
  • The medical marijuana testing laboratory shall produce a documented summary of all the cases of unsatisfactory results in the facility. Details to be included in the summary are the briefs on the investigation and the conclusion of individual cases of unsatisfactory results obtained in the laboratory
• The medical marijuana testing laboratory must participate in proficiency testing (PT)/Inter-laboratory comparison(ILC) on all processes involved in the scope of the accreditation, including test technologies and other parameters. The evaluation of the performance of a testing laboratory concerning established criteria is termed proficiency testing

How to Get a Marijuana Testing Laboratory License in South Dakota

Applicants for a medical marijuana testing laboratory license in South Dakota may register online through the Medical Cannabis Program. The portal requires applicants to create an account with either a name or a username and a password. The South Dakota Department of Health offers a checklist of application documents to be submitted for the application document through the medical cannabis program online. The information required of applicants to provide include:

• Applicants contact information
• Establishment information:
  • Applicants are required to provide a copy of their South Dakota sales tax ID. However, applicants who have submitted applications without sales tax ID before November 1, 2021, need to provide the ID within 14 days from the date of submission.
  • Applicants are required to provide the physical address of the medical marijuana testing laboratory. If there is more than one laboratory, they will need to provide the address of each of them.
  • Applicants are required to provide information about the operational procedures of their testing laboratory. This should include the types of marijuana testing they conduct, the materials used for these tests, and the procedures used. The online application portal will generate queries for the applicant according to the operation they claim to undertake.
  • Applicants are required to provide photocopies of their operating procedures in compliance with Article 44:90:03:07 of South Dakota. This includes:
    • A policy document signed by each of the owners of the marijuana testing laboratory certifying that the facility is free from any undue internal and external influence. This policy document must include:
      • Commercial influence
      • Financial influence
      • Other types of influence that may negatively affect their performances or diminish public confidence in their judgment, competence or operational integrity.
    • A signed disclosure by each of the owners, certifying that there are no conflicts of interest in the establishment.
    • A list of analytical tests that they conduct in the medical marijuana testing laboratory. Applicants need to specify the analytes and technologies involved in each of the tests. They also need to provide:
      • Evidence that the medical marijuana testing laboratory will begin to work with the ISO/IEC standards within six months of licensing. This should also include evidence that they have commenced the process to obtain ISO/IEC 17025 accreditation for all the analytical tests they conduct.
      • A document containing the standard operating procedures for all:
        • Preanalytical processes
        • Analytical processes
        • Post-analytical processes done by the medical marijuana testing laboratory.
      • A document containing the protocols with which the testing laboratory performs validation studies for all tests conducted in the laboratory
      • A document containing the protocols with which the testing laboratory conducts proficiency testing at stated intervals. The document should have records of successful completion of tests and corrective actions. The intervals and the corrective actions should be as prescribed by the accrediting body.
      • A prototype document for the periodic assessment (at least annually) of all the technical staff and scientific staff involved in the different stages of analytical processes
      • Document(s) certifying that the establishment has policies and procedures that protect clients’ confidential information and proprietary rights. Information to be protected includes electronic storage and transmission of results.
      • Document(s) stating the testing laboratory’s policies and procedures for collecting and receiving all types of samples. Parameters expected to be stated in the document include:
        • Detailed steps involved in the collection of samples from each matrix type that is representative of the batch to be tested
        • The sample size to be collected for each of the analytical tests.
        • Procedures established in the laboratory to prevent contamination of samples and analytes during testing. This includes the use of protective garb, sanitizing of equipment, and protection of sample collection containers.
        • Method of labeling for sample containers
      • A document stating the protocols for the chain of custody of the sample. This should include a sample chain of custody form.
      • A document listing all the equipment to be used in the testing laboratory
• A completed Local Government Compliance Certification form (Form E) obtained from their city, county, or municipal office.
• Personal information of each of the principal officers and board members of the marijuana testing facility. This information includes:
  • Full names
  • Dates of birth
  • Home addresses
  • Photocopies of a valid government-issued identification card
• An official declaration that:
  • All the information provided is complete and correct. They should also state that if any of the information about the testing laboratory changes, the change will be reported to the Department of Health within ten days
  • Any misrepresentation of information to the South Dakota Department of Health can be a ground for:
    • Denial of license
    • Suspension of license or
    • Revocation of License as may be decided by the department.
  • None of the principal officers or board members of the medical marijuana testing laboratory has ever had their license revoked by the South Dakota Department of Health or any other state authority in the U.S
  • All the principal officers and board members of the medical marijuana testing laboratory are 21 years of age or older
  • At least one of the principal officers of the establishment is from South Dakota.
  • The applicant ascertains that a background check has been conducted on each principal officer and board member of the marijuana testing laboratory. None of these must have been convicted for a felony offense in South Dakota or any other place
  • The applicant ascertains that a criminal background check has been conducted on each marijuana laboratory agent, and none has been convicted of a felony.
  • The medical marijuana testing laboratory will issue a badge to each of its agents for identification purposes
  • The medical marijuana testing laboratory shall comply with the approved operating plan by the Department of Health
  • The person signing the application documents for the medical marijuana testing laboratory is assumed to have the legal authority to act on behalf of the facility.
  • The applicant has authorized the inspection of their premises, vehicles, and records by submitting their application to the Department of Health. Records that the Department of Health may inspect include both paper and electronic records

How Much Does a Marijuana Testing Laboratory License Cost in South Dakota?

Applicants for the medical marijuana testing laboratory license in South Dakota are required to pay a nonrefundable application fee of $5,000. The applicant must pay the application fee when their license application is submitted, or the South Dakota Department of Health will not process the application.

Are there Local Regulations for Cannabis Testing Facilities in South Dakota?

Cities, counties, and municipalities regulate cannabis testing facilities in South Dakota. Many local governments have licensing and zoning ordinances, and they require compliance from prospective medical marijuana testing laboratories. Article 44:90:03:08 of South Dakota requires a medical marijuana testing laboratory to submit copies of the registration or permit required by their local government either at the point of license application or during license renewal. If the applicant’s local government does not require a permit or registration, the applicant will need to obtain a certificate from the local government, stating that they are not required to obtain any registration or license from the city or county.