Ohio Administrative Code › Title 3796:4 - Testing Laboratories › Chapter 3796:4-1 - Generally › Section 3796:4-1-02 - Testing laboratory provisional license application

Current through all regulations passed and filed through July 1, 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.