Ohio Administrative Code
Title 3796:4 - Testing Laboratories
Chapter 3796:4-1 - Generally
Section 3796:4-1-02 - Testing laboratory provisional license application
Universal Citation: OH Admin Code 3796:4-1-02
Current through all regulations passed and filed through September 16, 2024
(A) The department shall provide advance notice to the public indicating the commencement date and time period for accepting applications. The director shall have the right to amend the notice prior to the deadline for submitting an application. The director shall publish such amended notice in the same manner as the original notice. The director shall also have the right to cancel a notice of open application prior to the award of a testing laboratory provisional license.
(B) The provisional license application shall be submitted in accordance with Chapter 3796. of the Revised Code and this division. The application will include instructions for completion and submission. An applicant for a testing laboratory provisional license shall submit, in accordance with the application instructions, the following:
(1)
A non-refundable application fee as set forth in rule
3796:5-1-01 of the
Administrative Code.
(2)
A business plan, which, at a minimum, shall
include:
(a)
The legal name of the applicant;
(b)
The type of
business organization of the applicant, such as individual, corporation,
partnership, limited liability company, association, cooperative, joint
venture, or any other business organization;
(c)
Confirmation that
the applicant is registered with the secretary of state as the type of business
submitted pursuant to paragraph (B)(2)(b) of this rule, a certificate of good
standing issued by the secretary of state, and a copy of the applicable
business documents governing the operations and administration of the
business;
(d)
The proposed physical address of the applicant's
facility;
(e)
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;
(f)
Experience with the analytical testing of medical
marijuana or other agricultural, horticultural, or pharmaceutical
products;
(g)
All persons subject to the criminal records checks
shall submit both an Ohio bureau of criminal identification and investigation
criminal records check and a federal bureau of criminal investigation criminal
records check pursuant to division (B) of section
3796.12 of the Revised
Code;
(h)
Any instance in which a business that any person
associated with the applicant had managed or served on the board of the
business and was convicted, fined, censured, or had a registration or license
suspended or revoked in any administrative or judicial
proceeding;
(i)
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;
(j)
A location area map of the area surrounding the
proposed testing laboratory that establishes the facility is at least five
hundred feet from the boundaries of a parcel of real estate having situated on
it a prohibited facility, as measured under rule
3796:5-5-01
of the Administrative Code;
(k)
For any instance
in which an applicant or any person associated with the applicant is currently
or was previously licensed or authorized in another state or jurisdiction to
cultivate, produce, test, dispense, or otherwise deal in the distribution of
medical marijuana in any form, the following:
(i)
A copy of each
such licensing or authorizing document verifying licensure in that state or
jurisdiction;
(ii)
A statement granting permission to contact the
regulatory agency that granted the license, accompanied by the contact
information, to confirm the information contained in the application;
and
(iii)
If the license, authorization, or application was ever
warned, fined, denied, suspended, revoked, or otherwise sanctioned, a copy of
documentation so indicating, or a statement that the applicant was so licensed
and was never sanctioned; and
(l)
Documentation
that the applicant is currently in compliance, or will be in compliance prior
to the issuance of a certificate of operation, with all building, fire, safety,
and zoning statutes, local ordinances, and rules and regulations adopted by the
locality in which the applicant's property is located, which are in effect at
the time of the application, including but not limited to building department
approval demonstrating compliance with rules adopted by the board of building
standards pursuant to Chapters 3781. and 3791. of the Revised Code and any
applicable zoning considerations.
(3)
An operations
plan that establishes policies and procedures in accordance with the
requirements of ISO/IEC 17025 "General Requirements for the Competence of
Testing and Calibration Laboratories," that the applicant will implement for
the secure and proper analytical testing of medical marijuana, which, at a
minimum, shall include:
(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, at a
minimum, shall include:
(i)
Employee training standards for the safe operation and
maintenance of any and all instrumentation that will be used in the analytical
testing of medical marijuana conducted on an annual basis;
(ii)
Employee
training standards for the safe use, handling, storage and disposal of any and
all chemicals that will be used in the analytical testing of medical marijuana,
in accordance with OSHA protocols, conducted on an annual basis;
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 disposal of medical marijuana waste and other wastes that
ensure medical marijuana waste is rendered unusable.
(4)
A security plan
that establishes policies and procedures to prevent theft, loss, or diversion
from a testing laboratory and protect facility personnel, which, at a minimum,
shall include:
(a)
Record keeping policies and procedures that will ensure
the facility complies with rule
3796:4-2-06
of the Administrative Code;
(b)
A security plan
in accordance with rule
3796:4-2-07
of the Administrative Code;
(c)
Transportation
policies in accordance with rule
3796:4-2-10
of the Administrative Code; and
(d)
A plot plan of
the laboratory facility drawn to a reasonable scale that designates the
different areas of operation, with mandatory access restrictions.
(i)
If the building
is in existence at the time of the application, the applicant shall submit
plans and specifications drawn to scale for the interior of the
building.
(ii)
If the building is not in existence at the time of
application, the applicant shall submit a plot plan and a detailed drawing to
scale of the interior and the architect's drawing of the building to be
constructed.
(5)
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 at least two hundred fifty
thousand dollars in liquid assets for a testing laboratory provisional license,
which 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 per cent 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.
(6)
Any other information requested in the application
instructions that the department deems necessary to evaluate and determine the
applicant's suitability for a testing laboratory license.
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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
