Current through Register Vol. 49, No. 6, March 15, 2024
(1) The licensee shall establish, maintain,
and adhere to written policies and procedures for the cultivation, production,
manufacture, security, storage, inventory, distribution/transportation, and
testing of hemp and hemp extract. Such policies and procedures shall include,
but are not limited to, the following processes:
(A) Handling mandatory and voluntary recalls
of hemp and hemp extract due to any action initiated by the director or any
voluntary action initiated by the licensee, including the removal of
adulterated and/or misbranded hemp or hemp extract from possible distribution
and from registrants who have recalled hemp extract in their
possession;
(B) Preparing for,
protecting against, and handling any crisis that affects the operations of the
cultivation and production facility or cannabidiol oil care center(s) in the
event of strike, fire, flood, natural disaster, or other situations of local,
state, or national emergency;
(C)
Ensuring that any outdated, adulterated, damaged, deteriorated, misbranded,
and/or unusable hemp or hemp extract is segregated from other hemp and hemp
extract and disposed of in accordance with
2 CSR
70-14.140. This policy/procedure shall outline
requirements for written documentation/record of the hemp and hemp extract
disposition;
(D) Ensuring the
oldest hemp is used first in the processing and manufacture of hemp
extract;
(E) Ensuring all hemp and
hemp extract in the process of manufacture, distribution, or analysis shall be
stored in such a manner as to prevent diversion, theft, or loss and shall be
accessible only to the minimum number of authorized personnel essential for
efficient operation;
(F) Ensuring
all hemp and hemp extract shall be returned to a secure location immediately
after the completion of the process or at the end of the scheduled work day. If
a process cannot be completed by the end of a working day, the processing
equipment containing hemp or hemp extract shall be securely locked inside an
area that affords adequate security;
(G) Ensuring no person, except production
facility personnel, personnel from the Departments of Agriculture and Health
and Senior Services, and law enforcement officials shall be allowed on the
premises of a cultivation and production facility; and
(H) Ensuring all hemp extract complies with
the provisions of section
195.207,
RSMo and section
261.265,
RSMo and any regulations issued thereunder, through the implementation of a
sampling protocol, sample chain of custody procedure, and sample analysis for
the percentage of tetrahydrocannabinol (THC) and detection of pesticides for
each batch of hemp extract.
(2) Storage.
(A) Licensed cultivation and production
facility and cannabidiol oil care centers shall-
1. Not produce or maintain hemp in excess of
the quantity required for normal, efficient operation;
2. Have storage areas that provide adequate
lighting, ventilation, temperature, sanitation, humidity, space, equipment, and
security for the production and manufacture of hemp or hemp extract;
3. Maintain a separate secure area for hemp
and hemp extract that is outdated, adulterated, damaged, deteriorated,
misbranded, unusable, or whose sealed containers or packaging have been broken
or opened, until such material is disposed;
4. Keep all safes, vaults, or any other
equipment or areas used for cultivation, production, harvesting, processing,
manufacturing, or storage of hemp and hemp extract, securely locked and
protected from entry by unauthorized individuals;
5. Store all hemp extract in an approved safe
or approved vault and in such a manner as to prevent diversion, theft, or
loss;
6. Store all hemp in a secure
area, room, or location within the facility accessible only to authorized
facility personnel, the director or designated representative, or law
enforcement;
7. Have a sign posted
at all entries to storage areas of the facility containing hemp or hemp extract
stating: "Do Not Enter - Access Limited to Authorized Personnel
Only";
8. Be maintained in a clean
and orderly manner;
9. Be free from
infestation of pests, including insects, rodents, birds, vertebrates, and mold;
and
10. Ensure all areas of the
cultivation and production facility and cannabidiol oil care centers are
compartmentalized based on function and that access shall be restricted between
compartments.
(3) Inventory.
(A) Prior to commencing operations each
cultivation and production facility and cannabidiol oil care center shall-
1. Establish ongoing inventory controls and
procedures for conducting inventory reviews of hemp and hemp extract for the
purpose of detecting any diversion, theft, or loss in a timely manner;
and
2. Conduct a weekly inventory
of hemp and hemp extract in stock, which shall be recorded and maintained in
the hemp monitoring system and include, at a minimum:
A. Date of inventory;
B. Total amount of hemp by variety and lot
number and hemp extract by batch number;
C. Total amount of hemp and hemp extract
deemed unusable or placed under a department stop sale, use, or removal order
being held in quarantine for proper disposal; and
D. Name, signature, and title of the
employees conducting the inventory.
(4) Transportation and delivery of hemp, hemp
extract, and/or hemp waste by cultivation and production facility personnel.
(A) Each transport vehicle shall be staffed
with a delivery team consisting of a minimum of two (2) employees.
(B) At least one (1) delivery team member
shall remain with the vehicle at all times while the vehicle contains hemp,
hemp extract, and/or hemp waste.
(C) Each delivery team member shall have
access to a secure form of communication for the purpose of contacting
cultivation and production facility personnel and/or law enforcement, while the
vehicle contains hemp, hemp extract, and/or hemp waste.
(D) Each delivery team member shall possess
an identification card issued by the grower when transporting, delivering, or
distributing hemp, hemp extract, and/or hemp waste. Identification cards shall
be presented to the director or law enforcement officials upon
request.
(E) Each transport vehicle
shall carry a manifest. The manifest shall include the following information
and shall be maintained for three (3) years:
1. Names of delivery team
employees;
2. Licensed non-profit
entity's name;
3. Total quantity of
hemp, hemp extract, and/or hemp waste and lot or batch numbers being
transported for delivery;
4. Name
and address of each recipient;
5.
Date of delivery or distribution;
6. Total quantity delivered to the
recipient;
7. Name, title, and
signature of person taking possession of hemp, hemp extract, and hemp waste;
and
8. A signed chain of custody
documenting the delivery of hemp, hemp extract, and hemp waste.
(5) Testing.
(A) The cultivation and production facility
shall-
1. Create and follow an approved
protocol for sampling hemp and hemp extract;
2. Develop and implement a chain of custody
procedure for all samples;
A. Samples of hemp
and hemp extract, including duplicate samples shall be transported/delivered to
a department approved laboratory in a container that is secured in an outer
package that is sealed with an affixed label identifying the batch
number;
3. Direct the
approved laboratory to analyze all hemp extract samples for-
A. The percentage of tetrahydrocannabinol
(THC);
B. The percentage of
cannabidiol by weight;
C. Other
psychoactive substances; and
D. All
pesticides recorded under the requirements of
2 CSR
70-14.150;
4. Maintain all reports of analysis for all
samples of hemp and hemp extract in the hemp monitoring system; and
5. Notify the department within ten (10)
working days of receipt of any results of analysis showing noncompliance with
section
195.207,
RSMo or section
261.265,
RSMo or any regulations issued thereunder;
A.
Any positive result of analysis showing noncompliance with section
195.207,
RSMo section 261.265, RSMo or any regulations issued thereunder, makes the
tested hemp and hemp extract unusable and must be destroyed in accordance with
the requirements of
2 CSR
70-14.140.