Ala. Admin. Code r. 538-X-10-.09

Current through Register Vol. 43, No. 1, October 31, 2024

Section 538-X-10-.09 - Applications and Applications Processing As To State Testing Laboratories

(1)Generally. Applicants for a license to operate as a State Testing Laboratory under the Act and these Rules shall be governed by the Rules for filing applications and seeking a license contained in Chapter 3 (538-X-3-.01, et seq.), except as specifically modified below.

(2)Procedure for Filing Application - Contents of Application Specific to State Testing Laboratories. A State Testing Laboratory's application filed with the Commission shall conform to the following requirements for all licensees set forth in 538-X-3-.05 of Chapter 3 of these Rules, except as noted below:

(a) Cover Sheet-as provided in 538-X-3-.05 of Chapter 3 of these Rules.

(b) Summary Sheet- as provided in 538-X-3-.05 of Chapter 3 of these Rules.

(c) Application Information - as provided in 538-X-3-.0 S of Chapter 3 of these Rules, except as provided otherwise below:

1. The State Testing Laboratory Applicant's Verification regarding each business entity that has any ownership interest in the applicant shall conform with paragraph 3.a. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

2. The State Testing Laboratory Applicant's Verification regarding individuals having any ownership interest in the applicant, as to the identity, street address and responsible person of all entities with which the individual is connected, to the extent the entity is directly or indirectly involved in the cannabis industry, shall conform with paragraph 3.b. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

3. The State Testing Laboratory Applicant's Verification regarding any criminal history as to any owner, director, board member, or individual with a controlling interest in the applicant shall conform with paragraph 3.c. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

4. The State Testing Laboratory Applicant's verified licensing history, cannabis industry history, and tax history regarding itself or any affiliate shall conform with paragraphs 3.d., 3.e., and 3.f. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

5. The State Testing Laboratory Applicant's Verification regarding any public officials having any interest in the applicant shall conform with paragraph 3.g. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

6. State Testing Laboratory applicants must:

(i) identify which of the approved types of medical cannabis will be tested at each facility,

(ii) provide a summary of the processes and methods to be utilized to test each product, including the machinery, equipment, materials, and personnel necessary to test each product and

(iii) identify specific plans to ensure safety of personnel, facilities, and products being tested, based on the types of tests proposed to be utilized.

7. The State Testing Laboratory Applicant's statement of the anticipated or actual number of employees shall conform with paragraph 3.h. of Rule 538-X-3-.0 S of Chapter 3 of these Rules.

8. The State Testing Laboratory Applicant's statement of the number of days, if awarded a license, within which it will commence operations and reach full capacity shall conform with paragraph 3.i. of Rule 538-X-3-.0 S of Chapter 3 of these Rules.

9. The State Testing Laboratory Applicant's consent to the inspections, examinations, searches and seizures contemplated by § 20-2A-52(a)(3), Code of Alabama 1975 (as amended) shall conform with paragraph 3.j. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

10. The State Testing Laboratory Applicant's verification of the permissibility of its facilities' locations and compliance with all State and local laws shall conform with paragraph 3.k. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

11. The State Testing Laboratory Applicant's Verification that it and its leadership have no economic interest in any other license or Applicant for license under the Act or these Rules shall conform with paragraph 3.1. of Rule 538-X-3.05 of Chapter 3 of these Rules.

(3)Procedure for Filing Application - Exhibits to State Testing Laboratory's Application. Exhibits to the State Testing Laboratory Applicant's application information shall include all those as provided in subparagraphs 3.m.(1} through 3.m.(16} 538-X-3-.05 of Chapter 3 of these Rules, unless specifically provided otherwise as follows:

(a) State Testing Laboratory applicants must provide, as available, sales contracts and receipts, lease agreements or other documentation demonstrating possessory interest in all machinery and equipment to be used in the testing of cannabis or medical cannabis, as well as specifications and operations manuals of such machinery.

(b) State Testing Laboratory applicants must provide a quality control and quality assurance plan for each type of test to be performed on licensees' cannabis or medical cannabis identifying:

1. A summary of the collection protocols and procedures to be implemented by the State Testing Laboratory to ensure each sample's identity, adequacy, integrity, and freedom from cross-contamination.

2. A summary of the laboratory protocols and procedures to be adopted ensuring proper testing for the required safety, potency, stability, lifespan, and consistency of the cannabis or medical cannabis, whether as required by law or otherwise.

3. An overview of the steps to be taken in the testing process to provide high quality test results and/or to safeguard its testing procedures. The State Testing Laboratory Applicant must identify any specific plans to ensure integrity, consistency, efficacy, efficiency, economy, and accuracy of testing being performed at each facility, including whether and to what extent the State Testing Laboratory intends to implement these plans internally or to rely on any outside source to audit, evaluate and make recommendations to improve testing quality.

4. A summary of the tests that will be conducted, if any, with respect to each type of licensee or product.

5. A plan for reporting the results of testing upon a licensee's product, including the form to be utilized for providing said results to the licensee.

6. A plan for transportation of cannabis and medical cannabis to and from the State Testing Laboratory's facility.

7. Any steps that will be taken to differentiate between official tests and unofficial private testing performed at the request of a licensee.

8. A plan for managing the return and remediation or destruction of any failed test samples, including entry or monitoring the entry of the event on the Statewide Seed-to-Sale Tracking System.

9. Any specific plans to obtain and maintain accreditation as an ISO/IEC 17025 laboratory.

10. A detailed rendering of the information to be entered into the Statewide Seed-to-Sale Tracking System as to each sample obtained for testing.

(c) State Testing Laboratory applicants must provide:

1. A curriculum vitae for the business, demonstrating the education, experience, and other credentials of its leadership, including but not limited to all scientists and engineers employed at each facility.

2. A detailed explanation of the role each leader, scientist or engineer is to have in the processing of medical cannabis at each facility.

3. A 5-year hiring plan for its leaders, scientists, and engineers, identifying the types, positions, required education, required experience, and expected roles of such personnel.

(d) State Testing Laboratory applicants must provide copies of all contracts, contingent contracts, memoranda of understanding (or, if none of the foregoing are available, exemplars) between themselves and:

1. Any Cultivator or prospective Cultivator.

2. Any Processor or prospective Processor.

3. Any Secure Transporter or prospective Secure Transporter.

4. Any Dispensary or prospective Dispensary.

5. Any Integrated Facility or prospective Integrated Facility.

(e) State Testing Laboratory applicants must create a receiving and shipping plan that, at a minimum, ensures the following, in coordination with the contracted licensee:

1. Individual batches of cannabis being received for testing were appropriately prepared, tagged or otherwise identified, and inserted in containers at the time of receipt.

2. Batches and containers arriving from the licensee have been QR coded or otherwise digitally coded to identify, at a minimum, licensee, facility, plant tag identification number, date of harvest or processing, and the date (if any) of the last testing approval by a State Testing Laboratory.

3. Incoming cannabis or medical cannabis is accompanied by a manifest and other appropriate documentation; the information thereon is accurate and has been duly executed by all appropriate parties.

4. All information from the QR code relating to the incoming cannabis or medical cannabis, as well as the date and time of arrival, has been logged into the Statewide-Seed-to-Sale Tracking System.

5. Individual batches of medical cannabis arriving from a dispensary or from a processor after the packaging and labeling process has occurred, have been appropriately packaged, labeled, and inserted in containers prior to transport.

6. Batches and containers being transported back to a licensee from the State Testing Laboratory's facility must be QR coded or otherwise digitally coded to identify, at a minimum, the State Testing Laboratory and facility, the type of product, date of testing, and the date of the State Testing Laboratory's test approving or rejecting the product.

7. Outgoing test material is accompanied by an appropriate manifest and other appropriate documentation; the information thereon is accurate and has been duly executed by all appropriate parties.

8. All information from the QR code relating to the outgoing medical cannabis, as well as the date and time of shipment, has been logged into the Statewide-Seed-to-Sale Tracking System.

(f) Each State Testing Laboratory must establish policies for an adequate chain of custody and requirements for samples of products provided to the laboratory for testing or research purposes, including, without limitation, policies, and requirements for:

1. Issuing instructions for the minimum sample and storage requirements.

2. Documenting the condition of the external package and integrity seals utilized to prevent contamination of, or tampering with, the sample.

3. Documenting the condition and amount of the sample provided at the time of receipt.

4. Documenting all persons handling the original samples, aliquots, and extracts.

5. Documenting all transfers of samples, aliquots and extracts referred to another State Testing Laboratory for additional testing or whenever requested by a client.

6. Maintaining a current list of authorized medical cannabis establishment agents and restricting entry to the laboratory to only those authorized.

7. Securing the laboratory during nonworking hours.

8. Securing short- and long-term storage areas when not in use.

9. Utilizing a secured area to log-in and aliquot samples.

10. Ensuring samples are stored appropriately.

11. Documenting the disposal or return of samples, aliquots and extracts following the conclusion of testing.

(g) State Testing Laboratory applicants must provide a detailed recall, return and remediation plan that will be followed in the event one or more lots or batches being tested, is determined to require recall. The plan must include, but should not be limited to, the following:

1. Provisions for notifying the licensee of a failed test or other adverse event.

2. Factors about a failed test or adverse event that would likely necessitate a recall, and any potential for retesting or remediation of the product in question, and any guidance that will be offered to assist a notified licensee.

3. Responsible individuals or positions within the State Testing Laboratory who will liaison with the licensee during the recall process.

4. Notification protocols to other licensees and the Commission through the Statewide Seed-to-Sale Tracking System.

5. Processes to help ensure, in cooperation with the notified licensee, that the recalled product is returned, remediated (and approved as safe), or destroyed.

6. Processes to report to the Commission and any other appropriate regulatory body regarding crisis response and steps taken to mitigate or avoid danger to the public.

7. Steps to be taken to assist the notified licensee to avoid further contamination, to preserve and protect uncontaminated cannabis or medical cannabis, and to ensure access to said products by those who depend on it.

8. Any assistance to be provided to the notified licensee to investigate and analyze the factors that led to the need for recall, and the process by which to make any recommendations as to adjustments to the licensee's internal protocols and processes to avoid recurrence.

9. As necessary, any general or specific licensee advisories that should be offered to minimize the likelihood of duplication of the factors that led to the unsafe condition requiring recall.

10. As necessary, any public advisories that should be offered to minimize the risk of harm to patients, caregivers, and other members of the public.

(h) The State Testing Laboratory Applicant's Security Plan must include a plan for security at each facility, including but not limited to the following:

1. Twenty-four-hour alarm systems must be installed in all facilities where cannabis and/or medical cannabis are present.

(i) Such alarms shall be provided and installed by experts in industry-standard commercial-grade alarm systems.

(ii) Alarm systems must be fully operational, securing all entry points and perimeter windows, be equipped with motion detectors and pressure switches, and must cover all areas where cannabis or medical cannabis is delivered, received, handled, stored, prepared, tested, or readied for transport.

2. All ingress and egress points to the facility shall be equipped with digital tag in/tag out systems to preclude unauthorized access by the general public.

3. All ingress and egress points to the testing area shall be equipped with digital tag in/tag out systems to limit access as to all but authorized personnel within the facility.

4. Reception areas and personnel adjacent to ingress and egress points shall have ready access to duress panic and hold-up alarms that may be activated in the event of access by unauthorized personnel or intruders.

5. Broadcast communication devices (cell phones, intercom equipment or the like) must be:

(i) Carried by each employee or installed in all areas of each State Testing Laboratory's facility designed for regular access by humans.

(ii) Accessible for communication by all personnel at all times, and particularly at perimeter ingress/egress stations, facility reception areas, and the security office.

(iii) Capable of providing information with sufficient clarity to be heard and understood by all personnel and visitors within earshot of the employee receiving the communication.

6. A State Testing Laboratory's facility shall maintain an audio/video surveillance system that shall be in continuous operation 24 hours per day.

(i) Recording devices must be fully functional and fixed in place covering both the interior and exterior of the State Testing Laboratory's facility.

(ii) Recording devices must be in such quantity, with such lighting, and at such resolution as shall allow for the clear identification of individuals and activities in all reasonably accessible areas of the premises, including but not limited to all entrances, exits, parking lots, and any area where medical cannabis or medical cannabis is delivered, received, handled, stored, prepared, tested, or readied for transport.

(iii) Audio/Video surveillance recordings must clearly and accurately display the time and date.

(iv) Audio recordings must clearly and accurately capture conversations and activities to a level of 20 decibels within camera range.

7. The State Testing Laboratory facility's perimeter and any outdoor premises must be surrounded by a sufficient fence or barrier to prevent access by unauthorized persons and must have sufficient lighting to allow for the proper functioning of video surveillance equipment at all times between dusk and dawn or at any other time when ambient lighting requires enhancement to permit identification of individuals or activities upon or immediately adjacent to the premises. Indoor premises must likewise be sufficiently lit to allow for the identification of individuals and activities.

8. The State Testing Laboratory's facility must be housed in a stand-alone building or fully separated portion of a building accessible to and used by only authorized personnel; the area is not to be accessible to or used by scientists, engineers, or lab technicians not employed by the State Testing Laboratory. To the extent the State Testing Laboratory is housed within a larger facility, the portion dedicated to testing cannabis and medical cannabis must be self-contained or, at a minimum, segregated from the remainder of the activities being conducted in the larger facility by separate points of ingress and egress or, at a minimum, separately keyed and electronically protected entryways accessible only to employees of the State Testing Laboratory.

9. Exterior doors of each facility operated by a State Testing Laboratory must be designed or reinforced to withstand unlawful forcible entry; exterior doors shall remain locked against outside intruders at all times, while allowing free egress by the facility's occupants in the event of an emergency; doors must permit ingress to employees and other appropriate persons only by means of a keycard or other similar electronic access device.

10. Exterior walls of each facility operated by a State Testing Laboratory must be reinforced to withstand unlawful forcible entry. Windows, likewise, must be reinforced to prevent breakage by outside intruders.

11. State Testing Laboratory Facilities must provide and maintain a plan for sufficient staffing of security guards at each facility where cannabis and medical cannabis is present to reasonably ensure the safety of the products stored therein; however, the State Testing Laboratory's plan must provide, at a minimum, one (1) security guard per facility during the facility's business/operating hours.

12. Strict access controls shall protect areas where cannabis or medical cannabis is handled or stored - in a secured, locked room or vault.

13. Records, whether electronic or manual, must be kept of all persons on the premises at a facility at all times, including employees, vendors, transporters or other licensees, and all others, recording the individuals' name, date, time of ingress and egress, and (as to non-employees) the reason for their presence; such records shall be kept for a minimum of two years, and longer at the request of the Commission or law enforcement.

14. Audio/Video surveillance records must be kept for at least 60 days, and longer upon the request of the Commission, its inspectors, or any law enforcement personnel. Audio/Video recordings potentially reflecting an incident of actual or attempted diversion must be kept for the longer of a period of two years, or until resolution of the incident and apprehension and discipline or prosecution of the individuals involved in the actual or attempted diversion.

15. Employees, while on duty, shall wear identification badges that clearly identify them as employees.

16. Visitors, including vendors, other licensees, Commission members, inspection personnel, or other representatives must wear a "visitor pass" or "AMCC Official" pass, as applicable, at all times while on the premises. The State Testing Laboratory shall not be accessible by the members of the general public at any time.

17. State Testing Laboratories shall maintain, review and update policies to report theft, diversion, or other loss of cannabis or medical cannabis to the Commission and to law enforcement as early as practicable and not more than 24 hours from the event or its discovery.

18. Upon request, a State Testing Laboratory shall make available to the Commission or its inspectors all information relating to the State Laboratory's security plan, including but not limited to its security alarm systems, monitoring, alarm activity, maps of camera locations and camera coverage, audio/video footage, surveillance equipment maintenance logs, authorized use lists, operation instructions, and any other security- related information deemed relevant by the Commission or its inspectors.

(i) The State Testing Laboratory Applicant must provide an affidavit signed by the responsible individual and designated contact person (or, if the State Testing Laboratory is an entity, the duly authorized officer, owner or interest holder and the designated contact person) that the information provided in the Application is true and correct, to the best of the Affiants' knowledge upon a diligent investigation thereof.

(j) The State Testing Laboratory Applicant must provide the appropriate application fee as required by § 20-2A-55(f), Code of Ala. 1975, (as amended). The application fee is nonrefundable and must be submitted electronically per instructions in the Application Form received in response to the applicant's Request for Application.

(4) In all other respects except as expressly stated otherwise in this Rule, State Testing Laboratory Applicants shall be governed by the rules for applications and licensing generally pertaining to all applicants (Chapter 3 of these Rules).

Ala. Admin. Code r. 538-X-10-.09

Adopted by Alabama Administrative Monthly Volume XL, Issue No. 11, August 31, 2022, eff. 10/15/2022.

Author: William H. Webster

Statutory Authority:Code of Ala. 1975, §§ 20-2A-22, as amended.

The amended version of this section by Alabama Administrative Monthly Volume XLII, Issue No. 12, September 30, 2024, filed September 12, 2024 is not yet available.