Rule 351-7-.01 - Independent Laboratory Registration and Renewal(1) An independent laboratory shall be approved by the Commission prior to testing product in final packaged form from production licensees. The Commission hereby delegates the authority and responsibility to approve or deny registration forms submitted by independent laboratories to the GMCC Executive Director.(2) To request approval by the Commission, the requesting independent laboratory shall submit the following to the Commission: (a) A complete independent laboratory registration form as required by the Commission;(b) The required non-refundable registration fee as listed on the fee schedule;(c) The legal name of the independent laboratory as reflected in the articles of incorporation or organizational documents filed with the Georgia Secretary of State, including: 1. The type of corporation or entity of the independent laboratory;2. A copy of the independent laboratory's articles of incorporation, articles of organization, or partnership document; and3. The trade name of the independent laboratory, if applicable and if different from the legal name.(d) The physical address, county, and global positioning satellite coordinates where the independent laboratory is located;(e) The U.S. Postal Service mailing address of the independent laboratory;(f) The name(s) of the independent laboratory owner(s) and the director or agent;(g) The telephone number(s) of the independent laboratory director or agent;(h) The electronic mail address of the independent laboratory director or agent;(i) A copy of the secure and verifiable document as set forth in Code Section 50-36-2 for the independent laboratory owner;(j) Attestation that, upon registration with the Commission, the independent laboratory will maintain compliance with all local ordinances, rules, or regulations adopted by the locality where the independent laboratory is located, which are in effect at the time of submitting the registration form, including copies of any required local registration, license, or permit of the locality where the independent laboratory is located;(k) Documentation related to a certificate of accreditation for International Organization for Standardization ("ISO")/International Electrotechnical Commission ("IEC") 17025:2017 or higher: 1. A copy of such certificate for each required testing field as set forth in Rule 351-7-.08; or2. Records demonstrating that such certificate for each required testing field as set forth in Rule 351-7-.08 has been applied for, including all of the following: (i) A copy of the application to the accrediting body for ISO/IEC 17025:2017 (or higher) accreditation;(ii) Documentation of the payment receipt(s) for accreditation with the accrediting body;(iii) Documentation acknowledging receipt of the application and payment(s) by the accrediting body;(iv) Tentative schedule of any remaining steps in obtaining such certificate, including supporting documentation; and(v) Documentation from the accrediting body for all accreditation audit(s), including dates and status, that have been scheduled and completed.(l) A copy of the United States Department of Justice, Drug Enforcement Administration Controlled Substances Act Certificate of the independent laboratory.(m) A current copy of its standard operating procedures which shall address, at a minimum, the following: 1. Oversight of the independent laboratory, including, but not limited to, documentation of the reporting and management structure of the independent laboratory;2. Accurate record keeping;3. Employee safety and security;4. Safety and security plans, including a disaster plan with procedures to be followed in case of fire or other emergencies;5. Secure transportation plan and techniques for crime prevention;6. A job description or employment contract developed for all employees which includes duties, responsibilities, authority, qualification, and supervision;7. Alcohol and drug-free workplace policies;8. Storage of product in final packaged form prior to testing which ensure product quality and efficacy are maintained;9. Testing of product in final packaged form, including: (i) Each batch of product in final packaged form produced by a production licensee; and(ii) Product in final packaged form from a dispensing licensee, when necessary.10. A detailed description of how the product in final packaged form will be tested, including: (i) The process detailing how samples are collected by the independent laboratory;(ii) The number of samples tested;(iii) The size of sample tested;(iv) The tests conducted;(v) Creation and reporting of the certificate of analysis to the production licensee;(vi) Reporting results to the Commission; and(vii) Disposal of samples.11. An inventory of equipment and the methods used for the testing of product in final packaged form to detect the following for a certificate of analysis as set forth in Rule 351-7-.08: (ii) Cannabinoid profile;(vi) Visible foreign material;(vii) Microbiological contaminants and mycotoxins; and(n) Attestation that the registration form and its required documentation are true and current at the time of submission to the Commission and its employees.(o) Other information upon request by the Commission or its employees.(3) The Commission or the GMCC Executive Director may require a satisfactory compliance inspection prior to the approval of a registration.(4) An independent laboratory shall submit a complete registration form, fee, and required documentation as set forth in this rule, for each location of such laboratory.(5) If an independent laboratory applied for registration as set forth in Rule 351-7-.01(2)(k)(2), then documentation of ISO accreditation for each required testing field as set forth in Rule 351-7-.08 shall be received by the Commission and its employees within (180) days of the date of which the registration is approved. (a) If additional time is necessary to submit such documentation, then the independent laboratory shall submit a written request to the GMCC Executive Director for an extension of up to ninety (90) days to submit such documentation. Such a request shall include information to support such an extension and the time frame of which such documentation may be submitted to the Commission and its employees.(b) The Commission hereby delegates the authority and responsibility to determine whether an extension should be granted and to extend the time frame for the independent laboratory to submit such documentation to the GMCC Executive Director. If an extension is granted, then the independent laboratory shall submit to progress inspections by the Commission or its employees during the time frame of such extension.(6) The Commission may remove or not add an independent laboratory to the Commission's list of approved independent laboratories for noncompliance with the rules of the Commission.(7) An independent laboratory shall renew its registration annually, during an open renewal period announced by the Commission, by submitting to the Commission: (a) A complete independent laboratory registration renewal form;(b) Payment of the required non-refundable annual renewal fee;(c) Results of any internal or external audits conducted in the preceding twelve months; and(d) Results of the most recent third-party proficiency testing obtained by the independent laboratory as set forth in Rule 351-7-.02(6).(8) A registrant who does not submit a complete and timely renewal registration form shall be removed from the Commission's list of approved independent laboratories.Ga. Comp. R. & Regs. R. 351-7-.01
O.C.G.A. §§ 16-12-203, 16-12-210, 16-12-217.
Original Rule entitled "Independent Laboratory Registration and Renewal" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.Amended: F. Nov. 9, 2023; eff. Nov. 29, 2023.