CHAPTER 44:90:06
CANNABIS TESTING FACILITIES
Section
44:90:06:01 Required accreditation and registration -- Drug Enforcement Agency.
44:90:06:02 Adherence to standard operating procedures -- Quality control and quality assurance.
44:90:06:03 Sample collection.
44:90:06:04 Field audits.
44:90:06:05 Chain of custody protocols.
44:90:06:06 Chain of custody -- Forms.
44:90:06:07 Reporting of test results.
44:90:06:08 Analytical testing result verification.
44:90:06:09 Results of confirmation testing.
44:90:06:10 Transportation to the South Dakota Public Health Laboratory.
44:90:06:01. Required accreditation and registration -- Drug Enforcement Agency. Upon successful registration and prior to accepting cannabis or cannabis products for testing, a cannabis testing facility must:
(1) Begin working with an accreditation body to ensure compliance with applicable rules and ensure progress towards achieving ISO/IEC 17025 accreditation, with a scope of accreditation that includes all analytical tests performed by the facility; and
(2) Successfully complete accreditation within thirty-two months of registration.
If a cannabis testing facility fails to successfully complete accreditation within thirty-two months of initial registration, the department must revoke the facility's registration.
A cannabis testing facility shall register with the Drug Enforcement Agency pursuant to 21 C.F.R. part 1301.13, in effect on June 28, 2021.
Source: 48 SDR 40, effective October 5, 2021; 50 SDR 62, effective November 27, 2023.
General Authority: SDCL 34-20G-72(4)(k).
Law Implemented: SDCL 34-20G-72(4)(k).
Reference: International Organization for Standardization & International Electrotechnical Commission. (2018). ISO/IEC 17025:2017: General Requirements for the Competence of Testing and Calibration Laboratories. https://www.iso.org/standard/66912.html. Cost: $138.
44:90:06:02. Adherence to standard operating procedures -- Quality control and quality assurance. A cannabis testing facility shall adhere to:
(1) Written procedures for all preanalytical, analytical, and post-analytical processes;
(2) Quality control and quality assurance manual;
(3) Completion of validation studies of all analytical tests to be performed;
(4) Proficiency testing at an interval determined by the accrediting body;
(5) Achieving passing scores on each proficiency test or completion of corrective action, as defined by the accrediting body; and
(6) A program to assess and document, at least annually, the competency of all technical and scientific staff that perform preanalytical, analytical, and postanalytical processes.
Source: 48 SDR 40, effective October 5, 2021.
General Authority: SDCL 34-20G-72(5)(k).
Law Implemented: SDCL 34-20G-72(5).
44:90:06:03. Sample collection. Each cannabis testing facility shall adopt standard operating procedures for the collection of samples for testing that must address:
(1) Standards for the assignment of batch identifiers and sample identifiers;
(2) Minimum quantity of cannabis and cannabis products needed for each analytical test;
(3) Methodology for collecting material that is representative of the entire batch being tested;
(4) Cleaning, sanitizing, and other methods for preventing sample contamination;
(5) Containers to be used for sample collection, including methods for sealing; and
(6) Prevention of damage or degradation during storage and transport.
Source: 48 SDR 40, October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(k).
Law Implemented: SDCL 34-20G-72(5).
44:90:06:04. Field audits. Field audits must be conducted at least quarterly by the cannabis testing facility’s quality assurance staff to verify that samples are being collected in accordance with the cannabis testing facility’s standard operating procedures as follows:
(1) Reviewing sampling records from the previous quarter and previous year for signs of irregularities;
(2) Observing the collection of samples by each person authorized to collect samples;
(3) Collecting verification samples for comparison of results to samples collected by each person authorized to collect samples;
(4) Recording any deficiencies identified;
(5) Informing any affected cannabis cultivation facility or cannabis product manufacturing facility that past results may have been affected by any deficiencies uncovered; and
(6) Instituting corrective action.
Source: 48 SDR 40, effective October 5, 2021.
General Authority: SDCL 34-20G-72(5)(k).
Law Implemented: SDCL 34-20G-72(5).
44:90:06:05. Chain of custody protocols. The chain of custody protocols developed by a cannabis testing facility must be approved by the department and must address:
(1) Recording the possession of samples from the time of sampling through destruction;
(2) Retaining for not less than 90 days any residual samples in the container in which the sample was submitted;
(3) Handling procedures during collection, transport, and testing to avoid loss, damage, diversion, contamination, or misidentification of samples; and
(4) The use of a chain of custody form that documents the collection, transport, receipt, testing, and destruction of samples.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(k)(l).
Law Implemented: SDCL 34-20G-63, 34-20G-72(5).
44:90:06:06. Chain of custody -- Form. The chain of custody form must include:
(1) The sample location;
(2) The number and types of containers;
(3) The mode of collection;
(4) The authorized individual who collected the sample;
(5) The date and time of collection; and
(6) The requested analyses.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(k)(l).
Law Implemented: SDCL 34-20G-63, 34-20G-72(5).
44:90:06:07. Reporting of test results. The results of any analytical test of cannabis or cannabis products shall be provided to the cannabis cultivation facility or cannabis product manufacturing facility in the form of a certificate of analysis.
The cannabis testing facility shall update, each day by midnight, the inventory tracking system with:
(1) All samples collected; and
(2) The results of all voluntary and mandatory tests performed, including as applicable a quantitative value and whether the sample has passed or failed the test.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(d)(e)(h)(k)(l).
Law Implemented: SDCL 34-20G-63, 34-20G-72(5).
44:90:06:08. Analytical testing result verification. Prior to January 1, 2024, all medical cannabis and cannabis products tested by cannabis testing facilities are subject to routine confirmation testing by the department or department designee. The department shall conduct confirmation testing at regular intervals as needed to ensure consistent, reliable test results. Upon request, the cannabis testing facility must submit residual material from samples with complete testing results to the department or department designee. The department or department designee shall perform testing using an acceptable method to verify initial results.
On or after January 1, 2024, the department may reduce the frequency of routine confirmation testing for analytical tests within the scope of accreditation for an ISO/IEC 17025 accredited cannabis testing facility, if the cannabis testing facility:
(1) Participates in a proficiency testing program as defined by the ISO/IEC17025 accrediting body;
(2) Performs proficiency testing at an interval defined by the accrediting body; and
(3) Achieves a passing score on each proficiency test, or completes corrective action, as defined by the accrediting body.
The department may require all cannabis testing facilities to participate in confirmation testing to ensure the integrity of testing and consistency among cannabis testing facilities.
Source: 48 SDR 40, effective October 5, 2021.
General Authority: SDCL 34-20G-72(5)(k).
Law Implemented: SDCL 34-20G-69, 34-20G-72(5).
44:90:06:09. Results of confirmation testing. Results of confirmation testing conducted pursuant to § 44:90:06:08 must be made available to the originating cannabis testing facility. If initial testing results are found to be conforming, no additional action will be taken. If discordant results are encountered, the sample must be subjected to a third and final round of testing. If a third round of testing reveals discordant results, the cannabis testing facility must stop all testing of cannabis and cannabis products pending completion of a corrective action plan approved by the department.
Source: 48 SDR 40, effective October 5, 2021.
General Authority: SDCL 34-20G-72(5)(k).
Law Implemented: SDCL 34-20G-69, 34-20G-72(5).
44:90:06:10. Transportation to the South Dakota Public Health Laboratory. A cannabis testing facility that is directed by the department to transfer cannabis to the South Dakota Public Health Laboratory for testing pursuant to § 44:90:06:08 may transport the cannabis by use of a courier service designated by the South Dakota Public Health Laboratory in tamper resistant packaging, or as otherwise directed by the South Dakota Public Health Laboratory. The requirements of § 44:90:04:18 through 44:90:04:23 do not apply when cannabis is being transported to the South Dakota Public Health Laboratory.
Source: 49 SDR 47, effective November 22, 2022.
General Authority: SDCL 34-20G-72(5)(f).
Law Implemented: SDCL 34-20G-72(5).
