CHAPTER 44:90:09
SAMPLING AND TESTING
Section
44:90:09:01 Mandatory testing prior to transfer for retail sale.
44:90:09:02 Absence of mandatory testing.
44:90:09:03 Prohibited transfer of cannabis or cannabis product -- Exceptions.
44:90:09:04 Retention of certificate of analysis.
44:90:09:05 Payment of fees associated with testing.
44:90:09:06 Creation of batches.
44:90:09:07 Collection of samples -- Designee training requirements.
44:90:09:07.01 Requirements for samples of cannabis and cannabis products.
44:90:09:07.02 Procedures to ensure representative sampling.
44:90:09:08 Packaging of samples for testing.
44:90:09:09 Storage while awaiting test results.
44:90:09:10 Receipt of results -- Remediation.
44:90:09:11 Remediation of nonusable batches.
44:90:09:12 Destruction of nonusable batches -- Notice and recall.
44:90:09:01. Mandatory testing prior to transfer for retail sale. A medical cannabis establishment must test every batch of cannabis or cannabis product intended for retail sale in final form prior to transfer. Any alterations made by a medical cannabis establishment after receipt of cannabis or cannabis product results in the creation of a new final form.
The following tests are required for cannabis and cannabis products:
(1) Potency for tetrahydrocannabinol (THC) content and, if so labeled, cannabidiol content. The allowed variance for THC content may not exceed plus or minus ten percent;
(2) Microbials listed in subdivision 44:90:05:10(3);
(3) Mycotoxins listed in subdivision 44:90:05:10(2);
(4) Metals listed in subdivision 44:90:05:10(4) and § 44:90:07:03;
(5) Pesticides listed in subdivision 44:90:05:10(1); and
(6) Solvents listed in § 44:90:07:03.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022; 50 SDR 62, effective November 27, 2023.
General Authority: SDCL 34-20G-72(4)(d)(e)(l).
Law Implemented: SDCL 34-20G-72(4)(d)(e)(l).
44:90:09:02. Absence of mandatory testing. The absence of mandatory testing may not be interpreted to allow:
(1) The use of prohibited solvents or pesticides;
(2) Agricultural or manufacturing practices that promote the growth of mold, yeast, or bacteria; or
(3) Soil or growing media containing unsafe levels of lead, arsenic, cadmium, or mercury.
Source: 48 SDR 40, effective October 5, 2021.
General Authority: SDCL 34-20G-72(5)(d)(e).
Law Implemented: SDCL 34-20G-72(5).
44:90:09:03. Prohibited transfer of cannabis or cannabis product -- Exceptions. Except as allowed by § 44:90:09:11, no cannabis or cannabis products may be transferred by a cultivation facility or cannabis product manufacturing facility to a dispensary unless:
(1) A cannabis testing facility has performed all mandatory tests on the cannabis or cannabis products and determined it complies with this article; and
(2) The cannabis or cannabis products are accompanied by a certificate of analysis issued by the cannabis testing facility that covers all mandatory tests.
Except samples for testing, any cannabis or cannabis products transferred from a cultivation facility or a cannabis product manufacturing facility without a certificate of analysis is nonusable and may not be remediated.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(d)(e)(l).
Law Implemented: SDCL 34-20G-72(5).
44:90:09:04. Retention of certificate of analysis. A cannabis product manufacturing facility or medical cannabis dispensary shall maintain the certificate of analysis for any cannabis or cannabis products for 180 days or until all of the cannabis or cannabis products have been transferred or destroyed, whichever is later.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(d)(e)(l).
Law Implemented: SDCL 34-20G-72(5).
44:90:09:05. Payment of fees associated with testing. The medical cannabis establishment submitting the cannabis or cannabis products for testing shall pay all fees associated with testing.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(d)(e)(l).
Law Implemented: SDCL 34-20G-72(5).
44:90:09:06. Creation of batches. A cultivation facility or cannabis product manufacturing facility shall:
(1) Divide cannabis into homogenous batches not to exceed 50 pounds, and as directed by a cannabis testing facility;
(2) Divide cannabis products into homogenous batches as directed by a cannabis testing facility, and in accordance with the following size limitations:
(a) Cannabis product batches containing concentrated cannabis may not exceed 50 pounds (22.7 kilograms); and
(b) Cannabis product batches containing cannabis extract or products that are infused with cannabis or cannabis extract may not exceed 70,000 unpackaged retail servings;
(3) Assign a unique batch identifier to the cannabis or cannabis products; and
(4) When cannabis is harvested or trimmed:
(a) Cannabis flower shall be assigned to a batch containing a single strain from a single harvest date; and
(b) Cannabis trim may be assigned to a batch containing multiple strains and from multiple trimming dates.
A batch may be divided into multiple containers. If a cannabis or cannabis product yield is in excess of the batch size limitations, the yield must be divided into separate batches in accordance with this section in order to be sampled. With the exception of trim, all cannabis and cannabis products in each batch must be uniform throughout.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(d)(k)(l).
Law Implemented: SDCL 34-20G-72(5).
44:90:09:07. Collection of samples -- Designee training requirements. A cannabis testing facility or a designee of a cannabis testing facility shall collect representative samples for laboratory testing from each batch of cannabis or cannabis products created pursuant to § 44:90:09:06.
A cannabis testing facility designee may only collect samples on behalf of a cannabis testing facility upon completing the following requirements:
(1) Obtain documented authorization from testing facility;
(2) Complete no less than 10 hours of initial training on sample collection procedures that are in accordance with this chapter, provided by the testing facility; and
(3) Demonstrate competency in sample collection in compliance with the cannabis testing facility's sample collection procedures and this chapter.
A cannabis testing facility designee must attend no less than 10 hours of continuous training each year performed or approved by the testing facility in addition to the initial training requirements.
Prior to performing sample collection for mandatory tests, the cannabis testing facility designee shall contact the testing facility to obtain instructions for each sampling event, including the instruments to be used, the containers required to store samples, storage and transportation requirements, and the receipt and recordkeeping of the samples.
The collection of samples must comply in all manner with this section through § 44:90:09:09, the testing facility’s standard operating procedures and sample collection procedures, and requirements for ISO/IEC 17025 accreditation.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(d)(k)(l).
Law Implemented: SDCL 34-20G-72(5).
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.
44:90:09:07.01. Requirements for samples of cannabis and cannabis products. With the exception of pre-rolls, all cannabis and cannabis products must be in final form ready to be packaged upon receipt of passing results for all required tests in order to be sampled. A cannabis cultivation facility or cannabis product manufacturing facility may not alter the cannabis or cannabis product batch after sampling has occurred.
The cannabis testing facility or a designee of a cannabis testing facility shall sample the amount of cannabis and cannabis products in increments in accordance with the tables below, in addition to sample collection procedures:
| Cannabis Flower and Trim | ||
Batch Size Range (lbs) | Batch Size Range (kg) | Minimum Sample Amount (g) | Sample Increments Representing Total Minimum Sample Amount |
0-1.00 | 0 - 0.453592 | 2.50 | 5 |
1.01-10.00 | 0.4581283 - 4.53592 | 4.00 | 8 |
10.01-20.00 | 4.5404596 - 9.07185 | 7.50 | 15 |
20.01-40.00 | 9.0763833 - 18.1437 | 11.0 | 22 |
40.01-50.00 | 18.148231 - 22.6796 | 16.50 | 33 |
If a cannabis testing facility or a cannabis testing facility designee requires a sample amount that exceeds the minimum sample amount for cannabis batch size range as specified in the table above, the testing facility or designee must use sample increments of 0.5 grams.
| Cannabis Products – Concentrated Cannabis | ||
Batch Size Range (lbs) | Batch Size Range (kg) | Minimum Sample Amount (g) | Sample Increments Representing Total Minimum Sample Amount |
0-1.00 | 0 - 0.453592 | 1.25 | 5 |
1.01-2.00 | 0.4581283 - 0.907185 | 2.00 | 8 |
2.01-5.00 | 0.9117207 - 2.26796 | 3.75 | 15 |
5.01-15.00 | 2.272498 - 6.80389 | 5.50 | 22 |
15.01-50.00 | 6.8084215 - 22.6796 | 8.25 | 33 |
If a cannabis testing facility or a cannabis testing facility designee requires a sample amount that exceeds the minimum sample amount for the batch size range of a cannabis product containing concentrated cannabis, as specified in the table above, the testing facility or designee must use sample increments of 0.25 grams.
| Cannabis Products – Cannabis Infused Products | ||||
Batch Size Range (Unpackaged Servings) | Minimum Sample Amount (Unpackaged Servings) | Minimum Number of units for Sampling a 5-Serving Unit | Minimum Number of units for Sampling a 10-Serving Unit | Minimum Number of units for Sampling a 20-Serving Unit | Minimum Number of units for Sampling a 100-Serving Unit |
0-100 | 5 | 2 | 2 | 2 | 2 |
100-1,000 | 8 | 2 | 2 | 2 | 2 |
1,000-5,000 | 15 | 3 | 2 | 2 | 2 |
5,000-10,000 | 22 | 5 | 3 | 2 | 2 |
10,000-50,000 | 33 | 7 | 4 | 2 | 2 |
50,000-70,000 | 43 | 9 | 5 | 3 | 3 |
A serving unit is a single quantity of all pre-packaged total servings for one product package of cannabis infused product intended for sale.
The cannabis product manufacturing facility must determine the size of a serving for each cannabis infused product in accordance with § 44:90:07:04, and the number of servings in the cannabis product batch. If the minimum required number of sample servings does not align with the anticipated final form of the product, the cannabis testing facility or a cannabis testing facility designee must increase sample increments to ensure products are sampled in final form.
If a cannabis testing facility or a cannabis testing facility designee requires a sample amount that exceeds the minimum sample amount for the batch size range of a cannabis product containing cannabis infused cannabis, as specified in the table above, the testing facility or designee must use sample increments of one serving.
Source: 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(l).
Law Implemented: SDCL 34-20G-72(5).
44:90:09:07.02. Procedures to ensure representative sampling. A cannabis testing facility or a cannabis testing facility designee must sample in accordance with the cannabis testing facility's own sample collection procedures as well as the following procedures to ensure representative sampling:
(1) Check the cannabis or cannabis product batch in its entirety for any signs or indications of non-uniformity and differences from content appearing on the batch label;
(2) Homogenize the cannabis or cannabis product batch;
(3) Confirm the cannabis or cannabis product batch size matches the information in the inventory tracking system;
(4) Randomly select sample increments throughout each cannabis or cannabis product batch following sample collection procedures representing no less than the total minimum sample requirements in accordance with § 44:90:09:07.01;
(5) Take equal portions for each sample increment; and
(6) Record all observations and procedures used for the collection of each sample increment and maintain records pursuant to § 44:90:11:02.
Source: 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(l).
Law Implemented: SDCL 34-20G-72(5).
44:90:09:08. Packaging of samples for testing. All samples of cannabis or cannabis products must be transferred to a testing facility in sealed, child-resistant, and tamper-evident containers that are supplied by a testing facility or that meet criteria specified by a testing facility.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(f)(k)(l).
Law Implemented: SDCL 34-20G-72(5).
44:90:09:09. Storage while awaiting test results. A cultivation facility or cannabis product manufacturing facility awaiting testing results shall:
(1) Enter the identification number of the batch and the identification number of the samples associated with the batch into the establishment’s inventory records;
(2) Store the batch in one or more sealed containers enclosed on all sides; and
(3) Affix to the container a label including the following information:
(a) The establishment’s identification number;
(b) The batch number entered into inventory records;
(c) Name and identification number of the testing facility that will perform the tests;
(d) The sample’s unique identification number;
(e) The date the samples were taken; and
(f) In bold, capital letters, no smaller than 12-point font, PRODUCT NOT TESTED.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(f)(l).
Law Implemented: SDCL 34-20G-72(5).
44:90:09:10. Receipt of results -- Remediation. Upon receipt of a certificate of analysis indicating that cannabis or cannabis products comply with SDCL chapter 34-20G and this article and after the cannabis testing facility updates the inventory tracking system, the cannabis cultivation facility or cannabis product manufacturing facility may transfer the cannabis or cannabis products to another medical cannabis establishment, subject to the inventory tracking requirements of this article.
Upon receipt of a certificate of analysis indicating that cannabis or cannabis products are nonusable, the cannabis or cannabis products shall remain, until remediated or destroyed in accordance with this article, in the same storage container with a new label depicting:
(1) The establishment’s identification number;
(2) The batch number entered into inventory records;
(3) Name and identification number of the testing facility that will perform the tests;
(4) The sample’s unique identification number;
(5) The date the samples were taken;
(6) The reason for failed analytical testing; and
(7) In bold, capital letters, no smaller than 12-point font, PRODUCT FAILED TESTING.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(d)(e)(f)(l).
Law Implemented: SDCL 34-20G-72(5).
44:90:09:11. Remediation of nonusable batches. A cultivation facility or cannabis product manufacturing facility may elect to remediate a batch of cannabis or cannabis products that failed testing, provided that:
(1) Cannabis and cannabis products that fail tests for metals or pesticides may not be remediated;
(2) Cannabis and cannabis products that fail tests for prohibited solvents may not be remediated;
(3) An establishment shall outline its processes for remediating cannabis and cannabis products in its operating procedures;
(4) An establishment shall obtain department permission before remediating a batch of cannabis or cannabis products; and
(5) Any cannabis or cannabis products must be retested and must pass all required tests after remediation.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(d)(e)(l).
Law Implemented: SDCL 34-20G-72(5).
44:90:09:12. Destruction of nonusable batches -- Notice and recall. If a cultivation facility or cannabis product manufacturing facility is unable or unwilling to remediate a nonusable batch of cannabis or cannabis products, the establishment shall:
(1) Note in the inventory tracking system, or if unavailable, provide notice within one business day in writing to the department, that the establishment will destroy the cannabis or cannabis products;
(2) Follow the procedures for destroying cannabis waste in the establishment’s approved operating procedures; and
(3) Ensure that destruction of the nonusable batch is captured by functioning security cameras and stored according to this article.
If a cultivation facility or cannabis product manufacturing facility fails to follow the procedures under this section, the department shall notify all medical cannabis dispensaries that the inventory tracking system batch number associated with the unusable batch has not passed the required tests pursuant to § 44:90:09:01. The department shall provide procedures for recall pursuant to § 44:90:12:02 if the unusable cannabis or cannabis product has been made available for retail sale.
Source: 48 SDR 40, effective October 5, 2021; 49 SDR 9, effective August 8, 2022.
General Authority: SDCL 34-20G-72(5)(d)(e)(l).
Law Implemented: SDCL 34-20G-72(5).
