Ohio Administrative Code
Title 3796:4 - Testing Laboratories
Chapter 3796:4-1 - Generally
Section 3796:4-1-03 - Testing laboratory application review
Universal Citation: OH Admin Code 3796:4-1-03
Current through all regulations passed and filed through September 16, 2024
(A) The department, an independent contractor selected by the department, or a combination of the two shall review the submitted applications as described in this chapter and the application instructions. In order to receive consideration under paragraph (B) of this rule, an applicant shall:
(1)
Demonstrate
sufficient liquid capital pursuant to rule
3796:4-1-02
of the Administrative Code and an ability to meet the financial responsibility
requirements under rule
3796:4-1-05
of the Administrative Code;
(2)
Certify in
writing at the time of application that an owner or prospective owner, officer
or prospective officer, board member or prospective board member, administrator
or prospective administrator, employee or prospective employee, agent or other
person has not been:
(a)
Convicted of a disqualifying offense, as defined in
rule
3796:1-1-01 of the
Administrative Code; or
(b)
Issued a certificate to recommend or applied for
certification under section
4731.30 of the Revised
Code;
(3)
Verify that the proposed facility is not located within
five hundred feet from a prohibited facility, which shall be measured in
accordance with rule
3796:5-5-01
of the Administrative Code;
(4)
Certify that the
local jurisdiction where the facility is proposed has not passed a moratorium
or taken other action that would prohibit the applicant from operating as a
medical marijuana testing laboratory;
(5)
Certify that an
owner or prospective owner, officer or prospective officer, board member or
prospective board member, administrator or prospective administrator, employee
or prospective employee, agent, or other person who may significantly influence
or control the activities of the testing laboratory does not have a direct or
indirect financial interest in, or serve as an owner, officer, board member,
administrator, employee, agent, or other person who may significantly influence
or control the activities of any of the following:
(a)
A cultivator,
processor, or dispensary licensed under Chapter 3796. of the Revised
Code;
(b)
An applicant for a cultivator, processor, or dispensary
license;
(6)
Provide documentation sufficient to establish that the
applicant is in compliance with the applicable tax laws of this state and any
jurisdiction where the applicant operates and conducts
business;
(7)
Submit an application with the applicable fee under
rule
3796:5-1-01 of the
Administrative Code during the established application submission period
established under paragraph (A) of rule
3796:4-1-02
of the Administrative Code. The application shall be submitted in accordance
with the application instructions and forms issued by the department. The
department may remove an application from consideration for any of the
following:
(a)
Failure or refusal to submit information required under rule
3796:4-1-02
of the Administrative Code or requested by the department during the
application submission or review process;
(b)
Inclusion of
information in the application that misleads the department, misrepresents a
material fact, or fails to disclose a material fact to the
department;
(c)
Submission of an application that is in violation of
the application instructions issued by the department, or includes forms issued
by the department that have been altered.
(B) The applicants shall be evaluated using an impartial and numerical process taking into account the criteria identified in rule 3796:4-1-02 of the Administrative Code, as developed by the department, an independent contractor selected by the department, or a combination of the two. The applicants will be evaluated based on the following criteria, at a minimum:
(1)
A
business plan, which, at a minimum, shall include:
(a)
A proposed
business model demonstrating a likelihood of success, a sufficient business
ability and experience on the part of the applicant;
(b)
An organizational
chart of the company, including name, address, and date of birth of each
principal officer and board member of the testing laboratory, provided that all
those individuals shall be at least twenty-one years of age;
(c)
Experience with
the analytical testing of medical marijuana or other agricultural,
horticultural, or pharmaceutical products, which includes information on
licenses held by any person affiliated with the applicants, regardless if said
license is active or expired. If expired, applicant shall provide the grounds
behind the expiration. The information provided on business licenses shall
include the type of license, the licensing agency, the date the license was
obtained, and a summary of any negative actions taken against each
license.
(d)
Evidence that the applicant owns the property on which
the proposed testing laboratory will be located, has executed a lease for the
property that does not contain any use restrictions that would otherwise
prevent the testing laboratory from operating pursuant to Chapter 3796. of the
Revised Code and the rules promulgated in accordance with Chapter 3796. of the
Revised Code, or has secured the ability to purchase or lease the property that
does not contain any use restrictions that would otherwise prevent the testing
laboratory from operating pursuant to Chapter 3796. of the Revised Code and the
rules promulgated in accordance with Chapter 3796. of the Revised
Code;
(e)
Documentation that the applicant is currently in
compliance, or will be in compliance prior to the issuance of a certificate of
operation, with any local ordinances, rules or regulations adopted by the
locality in which the applicant's property is located, which are in effect at
the time of the application. Such documentation may include, but is not limited
to, local building department approval demonstrating compliance with rules
adopted by the board of building standards pursuant to Chapters 3781. and 3791.
of the Revised Code to construct the proposed facility, local approval to
operate as a medical marijuana cultivation facility, and evidence that the
applicant's proposed location is in compliance with local ordinances, rules or
regulations adopted by the locality in which the applicant's property is
located, which are in effect at the time of the application.
(2)
An
operations plan, which shall include but not be limited to:
(a)
Laboratory
analysis techniques, including specific instrumentation and protocols necessary
to perform the tests required by this division;
(b)
The
implementation of standards and methods for conducting testing laboratory
analysis of medical marijuana and medical marijuana products that will allow
the applicant to obtain accreditation to the ISO/IEC 17025 "General
Requirements for the Competence of Testing and Calibration Laboratories"
standard within two years of issuance of a provisional license;
(c)
A list of
proposed analytical services to be offered;
(d)
Facility
specifications, designating the areas in the facility where analytical testing
will occur, and evidencing that the applicant will comply with the requirements
of Chapter 3796. of the Revised Code and will operate in accordance with the
rules promulgated pursuant to Chapter 3796. of the Revised
Code;
(e)
Facility staffing and employment matters, which shall
include, but not be limited to;
(i)
Employee training standards for the safe operation and
maintenance of any and all instrumentation that will be used in the testing of
medical marijuana;
(ii)
Employee training standards for the safe use, handling,
storage, and disposal of any and all chemicals that will be used in the testing
of medical marijuana, in accordance with OSHA protocols; and
(iii)
Employee
compliance with Chapter 3796. of the Revised Code and the rules promulgated in
accordance with Chapter 3796. of the Revised Code;
(f)
Compliance with
the inventory tracking system implemented by the department;
and
(g)
Policies and procedures for the destruction and
disposal of medical marijuana waste and other wastes that ensure medical
marijuana waste is rendered unusable.
(3)
A security plan,
which shall include but not be limited to:
(a)
Policies and
procedures to ensure a secure, safe facility to prevent theft, loss, or
diversion and protect facility personnel;
(b)
Physical
equipment used to monitor the facility and meet the security requirements under
Chapter 3796. of the Revised Code and the rules promulgated in accordance with
Chapter 3796. of the Revised Code;
(c)
Emergency
notification procedures with the department, local law enforcement, and
emergency response professionals;
(d)
A plot plan of
the laboratory facility drawn to a reasonable scale that designates the
different areas of operation, with the mandatory access restrictions;
and
(e)
Transportation policies and procedures, which includes
the transportation of medical marijuana from a cultivator or processor licensed
by the department to the proposed testing laboratory in the state of Ohio, in
accordance with rule
3796:4-2-10
of the Administrative Code.
(4)
A financial plan,
which, at a minimum, shall include:
(a)
The identity and ownership interest of every person,
association, partnership, other entity, or corporation having a financial
interest, direct or indirect, in the testing laboratory with respect to which
licensure is sought;
(b)
A cost breakdown of the applicant's anticipated costs
in building the facility and implementing the policies and procedures submitted
as part of the application and the source of funding for the associated
costs;
(c)
Documentation acceptable to the department that the
individual or entity filing the application has secured at least two hundred
fifty thousand dollars in liquid assets for a testing laboratory provisional
license are unencumbered and can be converted within thirty days after a
request to liquidate such assets;
(i)
Documentation acceptable to the department includes a
signed statement from an Ohio licensed certified public accountant attesting to
proof of the required amount of liquid assets under the control of an owner or
the entity applying, if such a statement is available at the time of
application.
(ii)
The documentation must be dated within thirty calendar
days before the date the application was submitted.
(d)
Information
verifying that the applicant will be able to conform to the financial
responsibility requirements under rule
3796:4-1-05
of the Administrative Code; and
(e)
A record of tax
payments in the form of tax summary pages for individuals and businesses at the
state and federal level in this state and in all jurisdictions in which an
applicant has operated as a business and for every person with a financial
interest of one percent or greater in the applicant for the five years before
the filing of the application, unless the department determines that
documentation should be submitted for all individuals and
entities.
(5)
Any other information that the department deems
necessary to evaluate and determine the applicant's suitability to operate as a
medical marijuana testing laboratory.
(C) In addition to the criteria established in paragraph (B) of this rule, the department may also consider the following when awarding a provisional license:
(1)
Principal place
of business;
(a)
The applicant must provide documentation establishing
that its principal place of business is headquartered in Ohio. The applicant
may also provide the names, addresses, and verification of any persons
associated with the applicant that have established residency in
Ohio.
(b)
The applicant may also provide a plan for generating
Ohio-based jobs and economic development.
(2)
Employment
practices, in which the applicant must demonstrate a plan of action to inform,
hire, and educate minorities, women, veterans, disabled persons, and Ohio
residents;
(3)
Verification of economically disadvantaged groups;
and
(a)
The
applicant must demonstrate the following:
(i)
It is owned and
controlled by a United States citizen who is a resident of this state and is a
member of one of the economically disadvantaged groups set forth in division
(C) of section 3796.09 of the Revised Code. As
used in this rule, "owned and controlled" means that at least fifty-one per
cent of the business, including corporate stock if a corporation, is owned by
persons who belong to one or more of the groups set forth in this rule, and
that those owners have control over the management and day-to-day operations of
the business and an interest in the capital, assets, and profits and losses of
the business proportionate to their percentage of ownership; or
(ii)
It is owned and
controlled as a woman-owned business by a United States citizen who is a
resident of this state. For purpose of the paragraph, "owned and controlled"
has the same ownership and control requirements as listed in paragraph
(C)(3)(a)(i) of this rule.
(4)
Research plan, in
which the applicant must provide the department with a detailed proposal to
conduct or facilitate a scientific study or studies related to the medicinal
use of marijuana. Such a proposal shall address any applicable regulatory
restrictions and compliance therewith.
(D) The department may request additional information as part of the application review process from an applicant that otherwise meets all of the requirements under paragraph (A) of this rule. The applicant shall have thirty calendar days from the date the applicant receives the department's request to provide the information. If the applicant fails to provide the requested information within thirty calendar days, it will result in an abandoned application. An abandoned application shall not receive further consideration.
(E) An applicant forfeits all fees associated with an abandoned application. The department shall not be required to act on an abandoned application and the application may be destroyed by the department. An abandoned application will not prevent an applicant from applying for a provisional license in the future if the department issues additional provisional licenses pursuant to rule 3796:4-1-01 of the Administrative Code.
Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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