(a) Cultivator 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 cultivation of cannabis, as well as specifications and
operations manuals of such machinery and equipment.
(b) In addition to the requirements of
subparagraph 3.m.(16) of Rule
538-X-3-.05 of Chapter 3 of these
Rules, the Cultivator Applicant's verified Standard Operating Plan and
Procedures shall include the following:
1. A
grow plan that shall show the number of cannabis plants and methods of
cultivation the Cultivator intends to utilize.
2. Engineering plans and specifications of
the entire cultivation facility, which shall include the following:
(i) A detailed plan and elevation drawings of
all operational areas involved with the production of cannabis plants,
including dimensions and elevation referenced to a single facility
benchmark.
(ii) Cross-sections that
show the construction details and their dimensions to provide verification of
construction materials, enhancement for security measures, and bio-security
measures.
(iii) Identification of
all employee-accessible non production areas.
(iv) The location, size, and capacity of all
storage areas, ventilation systems, and equipment used for the production of
cannabis.
(v) The location and door
material specifications of all entrances and exits to the cultivation facility,
as well as the physical makeup and specifications of all outer walls of the
facility.
(vi) The location and
specifications of any windows, skylights and roof hatches.
(vii) The location of all monitoring cameras
and their field of view, verified to be operating 24 hours per day.
(viii) The location of all alarm inputs (door
contacts, motion detectors, duress/hold up devices) and alarm sirens.
(ix) The location of the digital video
recorder and alarm control panel.
(x) The location of all restricted,
employee-accessible and public areas.
(xi) The location where all plant inputs and
application equipment are stored.
(xii) The location of all enclosed, secure
areas or loading/ unloading docks out of public view for the loading/unloading
of cannabis or medical cannabis into or out of any motor vehicle for secure
transport.
(xiii) The location of
any area used to store medical cannabis that has been returned to the
cultivation facility from a Processor or Dispensary.
(c) Cultivator applicants must
provide a quality control and quality assurance plan for each of their proposed
facilities identifying:
1. An overview of the
steps to be taken in the manufacturing process to provide high quality products
and 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 cultivation.
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) Cultivator applicants must provide:
1. A curriculum vitae for the business,
demonstrating the education, experience, and other credentials of its
leadership employed at each facility.
2. A detailed explanation of the role each
leader is to have in the cultivation of cannabis at each facility.
3. A 5-year hiring plan for its leaders
identifying the types, positions, required education, required experience, and
expected roles of such personnel.
(e) Cultivator 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 Processor or prospective
Processor.
2. Any Secure
Transporter or prospective Secure Transporter.
3. Any Dispensary or prospective
Dispensary.
4. Any Integrated
Facility or prospective Integrated Facility.
5. Any State Testing Laboratory or
prospective State Testing Laboratory.
(f) Cultivator 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 and containers of cannabis being shipped for storage or processing 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), and the date of the Cultivator's State Testing Laboratory
testing approval.
2. All
information from the QR code relating to the outgoing cannabis, as well as the
date and time of shipment, has been logged into the Statewide Seed-to-Sale
Tracking System.
3. Outgoing
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. Incoming and outgoing medical cannabis is
accompanied by the Secure Transporters' manifest and other appropriate
documentation; the information thereon is accurate and has been duly executed
by all appropriate parties.
5. All
information from the QR code relating to incoming and outgoing medical
cannabis, as well as the date and time of shipment, has been logged into the
Statewide Seed-to-Sale Tracking System.
(g) Cultivator 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
Cultivator's 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 Applicant, demonstrating the size, color, logo, artwork, or
statements appearing on the packaging, as well as all childresistant,
tamper-evident, or other safety features, demonstrating conformity with the Act
and these Rules.
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 these Rules.
(h)
Cultivator 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 is not
limited to, the following:
1. Provisions for
notifying the Cultivator 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 Cultivator's organization who will oversee
the recall process.
4. Accounting
for the safety of employees and others on the premises.
5. Notification protocols to other licensees
and the Commission through the Statewide Seed-to-Sale Tracking System, and to
any other proper authorities.
6.
Processes to ensure that the recalled product is returned, remediated (and
approved as safe), or destroyed.
7.
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.
8. 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.
9. 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
Cultivator 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.
Cultivators, at each of their 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
facility, in such quantity, with such lighting, and at such resolution as shall
allow for the clear identification of individuals (i.e., as to determine the
facial features of all persons in the camera's view at all times of day) 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 cultivated, delivered, received, handled, stored,
prepared, processed, tested, packaged, labeled, or readied for transport.
Monitoring cameras at vehicle entry and exit points must be of such numbers,
scope, and clarity to record the license plate information and description of
all vehicles entering and exiting the facility. 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. (Note: 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.)
5. The Cultivator facility's perimeter and
any outdoor premises must be surrounded by a sufficient fence or barrier to
prevent access by unauthorized persons and to limit the visibility of the
cultivation facility, 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 Cultivator 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 Cultivator must be reinforced to withstand unlawful
forcible entry. Windows, likewise, must be reinforced to prevent breakage by
outside intruders.
8. Cultivators
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, the Applicant 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 each individual's name, the date and 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 Applicant's premises.
14. Cultivators 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 Cultivator shall make
available to the Commission or its inspectors all information relating to the
Applicant's security plan, including, but not limited 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 Cultivator shall make
available to the Commission or its inspectors all information relating to the
Cultivator's security plan.
(j) The Cultivator Applicant must provide an
affidavit signed by the responsible individual and designated contact person
(or, if the Cultivator 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 Cultivator 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, Cultivator
Applicants shall be governed by the rules for applications and licensing
generally pertaining to all applicants (Chapter 3 of these
Rules).