S.D. Admin. R. 44:90:03:07

Current through Register Vol. 51, page 51, October 21, 2024

Section 44:90:03:07 - Cannabis testing facility operating procedures - Additional requirements

The written operating procedures for a testing facility must provide the department with sufficient detail to determine the establishment's compliance with this article and SDCL chapter 34-20 G, including:

(1) A policy signed by each owner that ensures management and personnel are free from any undue internal and external commercial, financial, or other influences that may adversely affect the quality of their work or diminish confidence in its competence, impartiality, judgment, or operational integrity;

(2) A signed disclosure by each owner stating that there is no financial conflict with, interest in, investment in, landlord-tenant relationship with, or loan to a cannabis cultivation facility, cannabis product manufacturing facility, or cannabis dispensary;

(3) A list of analytical tests, specifying the analyte and technology for each, the applicant intends to offer and:

(a) Certification that the applicant will, within six months of licensing, begin working with an accreditation body to ensure compliance with applicable rules and ensure progress towards achieving ISO/IEC 17025 accreditation including all proposed analytical tests within its scope of accreditation; or

(b) If an initial application or a renewal application for a cannabis testing facility that has been licensed for less than 18 months, an agreement to:

(i) Submit quarterly reports to the department on its progress toward ISO/IEC accreditation; and

(ii) Comply with any department requests for confirmation testing at the cannabis testing facility's expense;

(4) Standard operating procedures for all preanalytical, analytical, and post-analytical processes performed by the laboratory;

(5) Protocols for performing validation studies of all analytical tests to be performed;

(6) Protocols for proficiency testing at an interval determined by the accrediting body and documenting successful completion or corrective action, as defined by the accrediting body;

(7) A program to assess and document, at least annually, the competency of all technical and scientific staff that perform preanalytical, analytical, and postanalytical processes;

(8) Policies and procedures that ensure the protection of its clients' confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results;

(9) Policies and procedures for collection and receipt of samples for mandatory or other testing, including:

(a) Step-by-step procedures for collecting samples from each matrix type that are representative of the batch to be tested;

(b) Method for collection, preparation, packaging, labeling, documentation, and transport of samples from each matrix type;

(c) Size of sample to be collected for each analytical test to be performed;

(d) Safeguards against contamination, including protective garb, sanitizing of instruments, and care of sample collection containers;

(e) Labeling of sample containers; and

(f) Transport and storage conditions, including exposure to light, temperature, and humidity;

(10) Chain of custody protocols and a sample chain of custody form;

(11) Training procedures and records of training for all cannabis testing facility designees to be maintained on the premises; and

(12) Equipment to be used and its listing by a nationally recognized testing laboratory.

S.D. Admin. R. 44:90:03:07

48 SDR 040, effective 10/5/2021; 49 SDR 009, effective 8/8/2022

General Authority: SDCL 34-20G-72(2)(5).

Law Implemented: SDCL 34-20G-55(1), 34-20G-72(5).

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.