Current through all regulations passed and filed through September 16, 2024
(A)
The submission of
an application that results in the issuance of a provisional license or
certificate of operation for a cultivator irrevocably gives the department
consent to conduct all inspections necessary to ensure compliance with the
cultivator's application, state and local law, Chapter 3796. of the Revised
Code, and the rules promulgated in accordance with Chapter 3796. of the Revised
Code. The department may conduct the inspection independently, or may work with
other departments, state agencies, or local authorities, including the Ohio
department of agriculture, the division of industrial compliance, and the
division of state fire marshal, to ensure compliance with the cultivator's
application, state and local law, Chapter 3796. of the Revised Code, and the
rules promulgated in accordance with Chapter 3796. of the Revised
Code.
(B)
An inspector conducting an inspection pursuant to this
rule shall be accompanied by a type 1 key employee during the inspection. The
inspector may:
(1)
Review and make copies of all records maintained in
accordance with rule
3796:2-2-08
of the Administrative Code;
(2)
Enter any area in
the facility, with a type 1 key employee's assistance if unaccompanied access
to an area could compromise production integrity or interrupt a dark cycle
during the flowering stage;
(3)
Inspect facility
vehicles;
(4)
Review the policies and procedures of the cultivator,
including methods of operating;
(5)
Survey the
premises and any off-site facilities;
(6)
Inspect all
equipment, instruments, tools, materials, machinery, or any other resource used
to cultivate medical marijuana;
(7)
Request access to
locked areas in the facility;
(8)
Question
registered employees at the location; or
(9)
Obtain samples
for testing of any medical marijuana cultivated at the facility, media used to
grow medical marijuana, chemicals and ingredients used in the cultivation
process, any labels or containers for medical marijuana, or any raw packaged
medical marijuana.
(C)
A pre-approval
inspection that is required before the department issues a certificate of
operation to a cultivator possessing a provisional license pursuant to rule
3796:2-1-06
of the Administrative Code shall occur at a mutually agreeable time. The
department shall rely on the facility's application, Chapter 3796. of the
Revised Code, and the rules promulgated in accordance with Chapter 3796. of the
Revised Code, to facilitate the inspection and ensure compliance of the
facility. Upon the completion of the pre-approval inspection, the department
may issue either of the following:
(1)
A certificate of operation in accordance with rule
3796:2-1-06
of the Administrative Code, at which point the facility will be permitted to
begin operations; or
(2)
A written statement listing the deficiencies identified
during the inspection that must be remedied before a certificate of operation
will be issued by the department.
(a)
Upon receipt of a statement of deficiencies, the
cultivator shall develop a plan of correction for each deficiency and submit
the plan in writing to the department for approval within ten business days
after receipt of the statement of deficiencies, unless a written extension is
issued by the department.
(b)
The plan of correction must include specific
requirements for corrective action that will be performed within either thirty
calendar days after the department's acceptance of the plan of correction or
the remaining time period under paragraph (B) of rule
3796:2-1-06
of the Administrative Code, whichever is greater.
(c)
If the plan of
correction submitted is not acceptable to the department or would prevent the
facility from obtaining a certificate of operation in accordance with rule
3796:2-1-06
of the Administrative Code, the department may either direct the cultivator to
resubmit a plan of correction or the department may develop a directed plan of
correction with which the cultivator must comply. Upon acceptance of the
written plan of correction, the cultivator shall sign the plan of correction,
binding the cultivator to the terms under which the cultivator may be issued a
certificate of operation. If the parties are unable to come to terms on the
written plan of correction, the department may take any action permitted under
rule
3796:5-6-01
of the Administrative Code.
(d)
The department
shall re-inspect a cultivator upon the completion of the written plan of
correction. If the corrective measures meet the department's satisfaction, the
department shall issue a certificate of operation. If the corrective measures
do not meet the requirements of the written plan of correction, the department
may take action in accordance with rule
3796:5-6-01
of the Administrative Code.
(D)
The department
may, at any time it determines an inspection is needed, with or without notice,
conduct an inspection of a cultivator to ensure compliance with the facility's
application, state law, Chapter 3796. of the Revised Code, and the rules
promulgated in accordance with Chapter 3796. of the Revised Code, in accordance
with paragraph (A) of this rule. An inspection of a cultivator may include,
without limitation, investigation of standards for safety from fire on behalf
of the department by the local fire protection agency. If a local fire
protection agency is not available, the division of state fire marshal may
conduct the inspection after the cultivator pays the appropriate fee to the
division of state fire marshal for such inspection.
(E)
Following an
inspection conducted pursuant to paragraph (D) of this rule, the department
shall issue an inspection report that documents the following:
(1)
The observations
and findings of the inspections;
(2)
The outcome of
the inspection;
(3)
Any suggestions for the cultivator to take into
consideration; and
(4)
If applicable, a written statement listing the
deficiencies identified during the inspection.
(a)
Upon receipt of
statement of deficiencies, the cultivator shall develop a plan of correction
for each deficiency and submit the plan in writing to the department for
approval within ten business days after receipt of the statement of
deficiencies, unless a written extension is issued by the
department.
(b)
The plan of correction must include specific
requirements for corrective action that will be performed within thirty
calendar days of the department's acceptance of the plan. If the plan of
correction submitted is not acceptable to the department, the department may
either direct the cultivator to resubmit a plan of correction or the department
may develop a directed plan of correction with which the cultivator must
comply. Upon acceptance of the written plan of correction, the cultivator shall
sign the plan of correction, binding the cultivator to the terms agreed upon by
the parties. If the parties are unable to come to terms on the written plan of
correction, the department may take any action permitted under rule
3796:5-6-01
of the Administrative Code.
(c)
The department
shall re-inspect a cultivator upon the completion of the written plan of
correction. If the corrective measures meet the department's satisfaction, the
department shall indicate such on the inspection report and conclude the
inspection. If the corrective measures do not meet the requirements of the
written plan of correction, the department may take action in accordance with
rule
3796:5-6-01
of the Administrative Code.
(F)
If an inspector
finds evidence of operational failures or conditions that create a likelihood
of diversion, contamination, risk to public health, or the occurrence of any
prohibited activity under rule 3796:5-6-02 of the Administrative Code, the
department may take immediate action authorized under rule
3796:5-6-01
of the Administrative Code.
(G)
To prevent
destruction of evidence, diversion, or other threats to public safety, the
department may order an administrative hold of medical marijuana or medical
marijuana product or any books and records of any cultivator. The department
may assess the costs of an investigation, including travel and the time of any
and all department employees, to a cultivator.
