Ala. Admin. Code r. 538-X-6-.06

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

Section 538-X-6-.06 - Applications And Licensing Procedures As To Processors Generally

(1)Generally. Applicants for a license to operate as a Processor 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 Processors. A Processor'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-.05 of Chapter 3 of these Rules, except as provided otherwise below:

1. The Processor 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 Processor 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 Processor 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 Processor 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 Processor Applicant's Verification regarding any public officials having any interest in the applicant shall conform with paragraph 3.g. of Rule 538-X-3-.0 S of Chapter 3 of these Rules.

6. The Processor Applicant's statement of the anticipated or actual number of employees shall conform with paragraph 3.h. of Rule 538-X-3-.05 of Chapter 3 of these Rules.

7. The Processor 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-.05 of Chapter 3 of these Rules.

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

9. The Processor 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.

10. The Processor Applicant's Verification that it and its leadership have no economic interest in any other license or Applicant for license under the Act or this Chapter 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 Processor's Application. Exhibits to the Processor Applicant's application information shall include all those as provided in subparagraphs 3.m.(1) through 3.m.(16) of 538-X-3-.05 of Chapter 3 of these Rules, unless specifically provided otherwise as follows:

(a) Processor 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 processing of medical cannabis, as well as specifications and operations manuals of such machinery.

(b) Processor applicants must:

1. identify which of the approved types of medical cannabis will be produced at each facility where cannabis is to be processed,

2. provide a summary of the manufacturing processes and methods to be utilized to produce each product, including the machinery, equipment, materials, and personnel necessary to produce each product,

3. identify specific plans to ensure safety of personnel and facilities based on the types of processes proposed to be utilized, and

4. provide a detailed list of formulae and ingredients for each medical cannabis product, including a list of all excipients to be utilized in the manufacture of each product, and the purpose served by each.

(c) Processor applicants must provide a quality control and quality assurance plan for each of their proposed medical cannabis products identifying:

1. An overview of the steps to be taken in the manufacturing process to provide high quality products and/or to ensure the safety, potency, stability, lifespan, and consistency among batches of the same product, whether as required by law or otherwise.

2. What tests will be conducted, if any, at each stage or stages of processing.

3. Whether the testing at each stage will be performed in house, through unofficial private testing performed by a State Testing Laboratory, or through an official test by a State Testing Laboratory.

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

(d) Processor 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.

(e) Processor 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 Secure Transporter or prospective Secure Transporter.

3. Any State Testing Laboratory or prospective State Testing Laboratory.

4. Any Dispensary or prospective Dispensary.

5. Any Integrated Facility or prospective Integrated Facility.

(f) Processor applicants must create a receiving and shipping plan that, at a minimum, ensures the following, in coordination with the contracted Secure Transporter or State Testing Laboratory, as applicable:

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

2. Batches and containers arriving from another licensee's facility or another of the Processor's own facilities have been QR coded or otherwise digitally coded to identify, at a minimum, the Cultivator, facility, plant tag or harvest batch number, date of harvest, expiration date (or, if no expiration date, a notation that the expiration date does not apply), the date of the cultivator's State Laboratory testing approval, and the Alabama Poison Control contact information as provided on the AMCC website.

3. Incoming cannabis is accompanied by the Secure Transporter's 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, 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 products being shipped from the Processor's facility to a Dispensary or Cultivator by means of a Secure Transporter must be appropriately packaged, labeled, and inserted in containers prior to transport.

6. Batches and containers being shipped from the Processor's facility to another licensee's facility or another of the Processor's own facilities must be QR coded or otherwise digitally coded to identify, at a minimum, the Processor, facility, type of product, date of processing and packaging, expiration date (or, if no expiration date, a notation that the expiration date does not apply), the date of the Processor's State Laboratory testing approval, and the Alabama Poison Control contact information as provided on the AMCC website.

7. Outgoing medical cannabis is accompanied by the Secure Transporter's 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.

(g) Processor applicants must provide a marketing and advertising plan, if any, including:

1. Any proposed logos, branding, messaging, or other marketing or advertising communications, providing exemplars of any specific advertisements.

2. Any specific media outlets or platforms where the marketing or advertising campaigns or programs will be utilized.

3. The identity of any media outlet or third-party individual or entity who is projected to play any role in the Processors' marketing or advertising efforts, and copies of all contracts or contract forms proposed for use, if any, between itself and such media outlet or third- party individual or entity.

4. Virtual renderings of all packaging to be provided by the Processor, demonstrating the size, color, logo, artwork, or statements appearing on the packaging, as well as all child- resistant, tamper-evident, or other safety features, demonstrating conformity with the Act and this Chapter.

5. Exemplars of all proposed labeling, including labels on packaging, on containers and any inserts to be included in any packages, demonstrating conformity with the Act and this Chapter.

(h) Processor applicants must provide a detailed recall plan that will be followed in the event one or more of its products, including any lots or batches thereof, is determined to require recall. The plan must include, but should not be limited to, the following:

1. Provisions for notifying the Processor of an adverse event;

2. Factors about an adverse event that would likely necessitate a recall, and any potential for retesting or remediation;

3. Responsible individuals or positions within the Processor's organization who will oversee the recall process;

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

5. Processes to ensure 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 avoid further contamination, to preserve and protect uncontaminated cannabis or medical cannabis products, and to ensure access to said products by those who depend on it; and

8. Investigation and analysis of the factors that led to the unsafe condition requiring the recall, and any adjustments to internal protocols and processes to avoid recurrence.

(i) The Processor 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 or medical cannabis products are present. Such alarms shall be provided and installed by experts in industry-standard commercial-grade alarm systems. 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 products are delivered, received, handled, stored, prepared, processed, tested, packaged, labeled, or readied for transport.

2. 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.

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

(i) Carried by each employee or installed in all areas of each Processor'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.

4. Processor's facilities shall maintain an audio/video surveillance system that shall be in continuous operation 24 hours per day. Cameras shall be fixed in place covering both the interior and exterior of the Processor's facility, 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 cannabis or medical cannabis is delivered, received, handled, stored, prepared, processed, tested, packaged, labeled, or readied for transport. Audio/Video surveillance recordings must clearly and accurately display the time and date. Audio recordings shall clearly and accurately capture sound within camera range at a level of 20 decibels or greater.

5. The Processor 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.

6. Exterior doors of each facility operated by a Processor must be designed or reinforced to withstand unlawful forcible entry; exterior doors shall, at all times, remain locked against outside intruders, 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.

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

8. Processor facilities must maintain 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, Processors must maintain, at a minimum, one (1) security guard per facility during the facility's business/operating hours.

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

10. 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.

11. 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.

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

13. 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.

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

15. Upon request, a Processor shall make available to the Commission or its inspectors all information relating to 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.

16. Upon request, a Processor shall make available to the Commission or its inspectors all information relating to the Processor's security plan.

(j) The Processor Applicant must provide an affidavit signed by the responsible individual and designated contact person (or, if the Processor 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.

(k) The Processor Applicant must provide the appropriate application fee as required by § 20-2A-22(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.

(l) In all other respects except as expressly stated otherwise in this Rule, Processor 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-6-.06

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.