Current through all regulations passed and filed through September 16, 2024
(A)
A cultivator
shall establish, maintain, and comply with the policies and procedures
contained in the operations plan submitted by the cultivator as part of the
application that was approved by the department. The operations plan shall
include policies and procedures for the production, storage, inventory, and
transportation of medical marijuana. At a minimum, a facility's operations plan
shall accomplish the following:
(1)
Designate areas in the facility that are
compartmentalized based on function, such as the marijuana cultivation area,
with restricted access between the different areas of the
facility;
(2)
Implement policies and procedures that provide best
practices for secure and proper cultivation of medical marijuana, which
includes restricted movement between the different production areas by
personnel based on access credentials assigned by the facility;
(3)
Document the
chain for all medical marijuana in the inventory tracking
system;
(4)
Establish a standard for the facility to be maintained
in a clean and orderly condition, which includes free from infestation by
rodents, insects, birds, and other animals of any kinds; and
(5)
Maintain a
facility with adequate lighting, ventilation, temperature, sanitation,
equipment and security for the safe and consistent cultivation of medical
marijuana.
(B)
A cultivator shall submit, as part of the application
process, and maintain a quality assurance and quality control plan for the
cultivation of medical marijuana in its facility. The purpose of the plan is to
ensure a safe, consistent product supply and minimize the deviation in quality
of the production batches of medical marijuana.
(1)
A cultivator
shall submit any proposed changes to its plan to the department sixty days
before the effective date of the proposed changes.
(2)
The department
shall have thirty days to review and approve or reject the proposed
changes.
(C)
The department, with assistance from the Ohio
department of agriculture, shall maintain an approved list of permitted
pesticides, fertilizers, and other chemicals. The department shall make this
list with the label type, active ingredients, and concentration of the approved
pesticides, fertilizers, and other chemicals available electronically. A
cultivator that utilizes any approved pesticides, fertilizers, or other
chemicals during the cultivation process shall meet the requirements contained
in this rule.
(1)
The pesticides must be registered with the Ohio
department of agriculture and meet either of the following requirements:
(a)
Registered with
the United States environmental protection agency under section 3 of the
Federal Insecticide, Fungicide, and Rodenticide Act,
7
U.S.C. 136-
136y
(2012); or
(b)
Exempt from registration under
40
C.F.R. 152.25(f) (2015) and
the active inert ingredients of the pesticide product are authorized for use on
crops or plants intended for human consumption by the United States
environmental protection agency.
(2)
Any specialty
fertilizer, as defined in division (Q) of section
905.31 of the Revised Code, must
be registered with the Ohio department of agriculture pursuant to section
905.33 of the Revised
Code.
(3)
No foliar application of approved pesticides,
fertilizers, or other chemicals shall be made after the twenty-first day
following the date that a plant is moved into the flowering stage of growth,
unless otherwise permitted on the department's approved list.
(4)
All individuals
applying pesticides, fertilizers, or other chemicals shall adhere to the use
requirements of the label and shall employ all applicable personal protective
equipment.
(5)
The cultivator shall comply with all posting
requirements of the standard protection language stated on the
label.
(6)
A record of all pesticide, fertilizer, or other
chemical applications shall be maintained by the cultivator for at least five
years and shall be made available to the department upon request. The
application record shall include the following information:
(a)
Date and time of
application;
(b)
Stage of cultivation process;
(c)
Date when the
plants in the application area were moved to the flowering stage, if
applicable;
(d)
United States environmental protection agency
registration number, if applicable;
(e)
Analysis of the
fertilizer applied;
(f)
Application site, which shall be identified by the
location legend maintained by the cultivator;
(g)
Name of the
product being applied;
(h)
Amount applied;
(i)
Unique plant
identifier or other information that identifies which plants received the
application;
(j)
Size of the application area;
(k)
Name of
individual making the application; and
(l)
Comments or
special conditions related to the application.
(7)
Disposal of all
unused pesticides, fertilizers, and other chemicals shall be performed in
compliance with all state and federal laws and regulations, which require
compliance with all directions on the product label.
(8)
The use of a
pesticide, fertilizer, or other chemical by a cultivator that is inconsistent
with the product's label or in violation of paragraph (C) of this rule may
result in action being taken by the department pursuant to rule
3796:5-6-01
of the Administrative Code.
(D)
A cultivator
shall maintain a facility in the following manner:
(1)
A cultivator
shall keep all floors and benches free of debris, dust, and any other potential
contaminants, remove dead and unusable plant parts from the marijuana
cultivation area, and control rodents and other non-plant related
pests.
(2)
A cultivator shall use chemicals, cleaning solutions,
and other sanitizing agents approved for use around vegetables, fruit, or
medicinal plants and shall store them in a manner that protects against
contamination.
(3)
A cultivator shall keep its equipment in a clean,
professional environment and maintain a cleaning and equipment maintenance log
at the facility.
(4)
The cultivator shall have its scales, balances, or
other weight and/or mass measuring devices routinely calibrated using "National
Institute of Standards and Technology" (NIST)-traceable reference weights, at
least once each calendar year, by an independent third party approved by the
department.
(5)
The water supply shall be derived from a source that is
a regulated water system or a private water supply and shall meet the needs of
the cultivator. A private water supply shall be derived from a water source
that is capable of providing a safe, potable, and adequate supply of
water.
(6)
A cultivator shall implement policies and procedures
related to receiving, inspecting, transporting, segregating, preparing,
packaging, and storing medical marijuana in accordance with adequate sanitation
principles.
