Chapter 3796:4-2 Operations

3796:4-2-01 Testing laboratory operations.

(A) A testing laboratory shall establish, maintain, and comply with the policies and procedures contained in the operations plan submitted by the testing laboratory as part of the application that was approved by the department. The operations plan shall include policies and procedures for the analysis, storage, sample inventory tracking, and transportation of plant material, medical marijuana extract, and medical marijuana products. At a minimum, a facility's operations plan shall accomplish the following:

(1) Designate areas in the facility that are compartmentalized based on function, including any areas to which access is restricted, and including areas that segregate samples awaiting analysis from those samples being analyzed or prepared for analysis, to prevent cross-contamination;

(2) Implement policies and procedures that provide best practices for safe, secure, and proper testing of medical marijuana;

(3) Establish training and safety policies and procedures to ensure that any person involved in analytical testing of medical marijuana:

(a) Has been fully trained in the safe operation and maintenance of any and all instrumentation that will be used in the testing of medical marijuana, with supporting documentation of the training;

(b) Has been fully trained in the safe use, handling, and storage of any and all chemicals that will be used in the testing of medical marijuana, in accordance with OSHA protocols, with supporting documentation of the training;

(c) Has direct access to applicable safety data sheets and labels; and

(d) Has been fully trained regarding compliance with Chapter 3796. of the Revised Code and the rules promulgated in accordance with Chapter 3796. of the Revised Code.

(4) Document the chain of custody for all medical marijuana in the inventory tracking system;

(5) 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 kind; and

(6) Maintain a facility with adequate lighting, ventilation, temperature, sanitation, equipment, and security for the testing of medical marijuana, including the following:

(a) A testing laboratory shall keep all floors and benches free of debris, dust, and any other potential contaminants;

(b) A testing laboratory shall use chemicals, cleaning solutions, and other sanitizing agents generally accepted for laboratory use, and shall store them in a manner that protects against contamination;

(c) A testing laboratory shall keep its equipment in a clean, professional environment and maintain a cleaning and equipment maintenance log at the facility, including preventive and routine maintenance plans and corresponding records, whether the preventive or routine maintenance is performed by laboratory staff or by service contract with third-parties or the original equipment manufacturer;

(d) A testing laboratory 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; and

(e) A testing laboratory shall standardize all analytical test instrumentation using reference materials traceable to reference material producers accredited to ISO/IEC 17034 "General Requirements for the Competence of Reference Material Producers" or the national metrology institute (NMI), where available.

(B) A testing laboratory shall employ a scientific director who will be responsible for supervision of all laboratory staff and for ensuring that the laboratory achieves and maintains quality standards of practice. The scientific director shall meet the following qualifications, at minimum:

(1) A doctorate degree in chemical, environmental, or biological sciences from an accredited college or university and two years of post-degree laboratory experience; or

(2) A master's degree in chemical, environmental, or biological sciences from an accredited college or university and four years of post-degree laboratory experience.

(C) A testing laboratory shall employ the following methods of analysis:

(1) Methods established in accordance with "Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control" (2014) monograph published by the "American Herbal Pharmacopoeia"; or

(2) Alternative methods that have been reviewed and approved by the department. If the proposed methods are approved, the department may require the testing laboratory to have the methods validated by an independent third party, at the expense of the testing laboratory, prior to the testing laboratory using the proposed methods to conduct testing services.

(D) A testing laboratory shall track and submit into the inventory tracking system any information the department determines necessary for tracking medical marijuana, including, but not limited to, transportation of samples, sample inventory, and results of analysis.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03 , R.C. 3796.09

3796:4-2-02 Testing laboratory proficiency testing and certification.

(A) Within two calendar years of the date of issuance of a provisional license by the department, a testing laboratory shall become accredited to the ISO/IEC 17025 "General Requirements for the Competence of Testing and Calibration Laboratories" standard by a non-profit accreditation body that is signatory to the "International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA)" and which operates in accordance with ISO/IEC 17011 "General Requirements for accreditation Bodies Accrediting Conformity Assessment Bodies," and shall consent to have all inspections and reports pertaining to certification and accreditation made available to the department.

(1) If the director believes that a testing laboratory has failed to meet the requirements of paragraph (A) of this rule, the director may issue a notice of noncompliance to a licensed testing laboratory. The notice shall include the factual basis for the director's belief, including any appropriate supporting documentation.

(2) Upon a notice issued pursuant to paragraph (B) of this rule, a testing laboratory may respond with any evidence sufficient to prove that the testing laboratory has met, and continues to meet, the standards established by paragraph (A) of this rule.

(3) If a testing laboratory fails to respond to a notice issued, or the director determines the evidence provided is insufficient to establish that the conditions in paragraph (A) of this rule have been met, the director shall move to fine, suspend, or revoke the testing laboratory certificate of operation pursuant to rule 3796:5-6-01 of the Administrative Code.

(4) At any time prior to the issuance of a notice of noncompliance under this rule, a testing laboratory may petition the director to toll computation of the time frames provided in paragraph (A) of this rule. Such a petition shall provide the following:

(a) An explanation of the facts and circumstances that will not allow the testing laboratory to become certified and accredited as required in paragraph (A) of this rule; and

(b) A plan for how and when the testing laboratory will be able to meet the requirement of paragraph (A) of this rule, with specific attention to how such a plan will allow the testing laboratory to meet the standards established in paragraph (A).

(5) Upon receipt of a petition under paragraph (E) of this rule, the director may stay the requirement of paragraph (A) of this rule for a testing laboratory. A director's order staying the requirement of paragraph (A) of this rule shall state the date upon which the stay is lifted using information provided by the testing laboratory in accordance with paragraph (E)(2) of this rule.

(B) The department may require a testing laboratory to participate in third party proficiency testing programs administered by organizations accredited to ISO/IEC 17043 "Conformity Assessment - General Requirements for Proficiency Testing," if such programs are available.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:4-2-03 Testing laboratory sample procurement.

(A) A testing laboratory shall collect samples of harvested plant material for analysis from a cultivator. Samples must be taken from each segregated, homogenized batch of harvested marijuana, as defined in rule 3796:1-1-01 of the Administrative Code, in such a manner as to ensure that a random sample is selected.

(B) A testing laboratory shall collect samples of medical marijuana products for analysis from a processor. Samples must be taken from each lot of medical marijuana products, as defined in rule 3796:1-1-01 of the Administrative Code, in such a manner as to ensure that a random sample is selected.

(C) A testing laboratory may collect samples of marijuana-derived ingredients, including but not limited to extracts, intended for use in the manufacture of medical marijuana products, if analysis is requested by a processor. Samples must be taken from each batch of marijuana-derived ingredients in such a manner as to ensure that a random sample is selected. Tests performed on medical marijuana extract may satisfy the requirements set forth in paragraph (C) of rule 3796:4-2-04 of the Administrative Code for the following analyses:

(1) Mycotoxin contamination;

(2) Heavy metal contamination;

(3) Pesticide and fertilizer residue contamination; or

(4) Residual solvent contamination.

(D) A testing laboratory may collect samples of plant material at any phase of cultivation for the purposes of assisting cultivators in research and development regarding new strains of medical marijuana or cultivation techniques, if analysis is requested by a cultivator. Tests performed pursuant to this paragraph must be reported to the department in accordance with rule 3796:4-2-05 of the Administrative Code, and the resulting certificate of analysis must be clearly marked with the phrase "For research and development only. Not for sale."

(E) A testing laboratory shall transport all samples in accordance with rule 3796:4-2-10 of the Administrative Code.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:4-2-04 Testing laboratory analysis requirements.

(A) A testing laboratory shall analyze a sample of at least one half of one percent of the net weight of the batch from each batch of dried, cured plant material intended to be sold to a dispensary licensed by the state of Ohio board of pharmacy for, at minimum:

(1) Moisture content;

(2) Water activity;

(3) Cannabinoid potency including, at minimum:

(a) Delta-9-tetrahydrocannabinolic acid (THCA);

(b) Delta-9-tetrahydrocannabinol (THC);

(c) Cannabidiolic acid (CBDA);

(d) Cannabidiol (CBD); and

(e) Cannabinol (CBN);

(4) Foreign matter contamination;

(5) Microbial contamination;

(6) Mycotoxin contamination;

(7) Heavy metal contamination including, at a minimum, arsenic, cadmium, lead, and mercury; and

(8) Pesticide and fertilizer residue.

(B) A testing laboratory shall analyze a sample of at least one half of one percent of the net weight of the batch from each batch of plant material intended to be sold to a processor licensed by the department for use in the manufacture of medical marijuana products for, at minimum:

(1) Pesticide and fertilizer residue; and

(2) Cannabinoid potency for, at a minimum:

(a) Delta-9-tetrahydrocannabinolic acid (THCA);

(b) Delta-9-tetrahydrocannabinol (THC);

(c) Cannabidiolic acid (CBDA);

(d) Cannabidiol (CBD); and

(e) Cannabinol (CBN);

(C) A testing laboratory shall analyze a sample of one unit of the same size, weight, and volume intended to be packaged and sold to a licensed dispensary from each lot of medical marijuana products prior to sale to a dispensary licensed by the state of Ohio board of pharmacy for, at minimum:

(1) Cannabinoid potency including, at minimum:

(a) Delta-9-tetrahydrocannabinolic acid (THCA);

(b) Delta-9-tetrahydrocannabinol (THC);

(c) Cannabidiolic acid (CBDA);

(d) Cannabidiol (CBD); and

(e) Cannabinol (CBN);

(2) Foreign matter contamination;

(3) Microbial contamination;

(4) Mycotoxin contamination, if a medical marijuana extract was used in the manufacture of the product that was not previously tested for mycotoxin contamination by a licensed testing laboratory;

(5) Heavy metal contamination including, at a minimum, arsenic, cadmium, lead, and mercury, if a medical marijuana extract was used in the manufacture of the product that was not previously tested for heavy metal contamination by a licensed testing laboratory;

(6) Pesticide and fertilizer residue, if a medical marijuana extract was used in the manufacture of the product that was not previously tested for pesticide or fertilizer residue contamination by a licensed testing laboratory; and

(7) Residual solvents, if a hydrocarbon-based medical marijuana extract was used in the manufacture of the product that was not previously tested for residual solvent contamination by a licensed testing laboratory.

(D) A testing laboratory may perform analysis on marijuana-derived ingredients used in the manufacture of medical marijuana products, including but not limited to medical marijuana extract. When performing analysis on medical marijuana-derived ingredients, the following sample sizes and required tests shall apply:

(1) A sample of at least one half of one percent of the net weight of the batch from a batch of medical marijuana extract derived from a system utilizing hydrocarbon solvents for, at minimum:

(a) Pesticide and fertilizer residue; and

(b) Cannabinoid potency including, at minimum:

(i) Delta-9-tetrahydrocannabinolic acid (THCA);

(ii) Delta-9-tetrahydrocannabinol (THC);

(iii) Cannabidiolic acid (CBDA);

(iv) Cannabidiol (CBD); and

(v) Cannabinol (CBN);

(c) Mycotoxin contamination;

(d) Heavy metal contamination including, at a minimum, arsenic, cadmium, lead, and mercury; and

(e) Residual solvents.

(2) A sample of at least one half of one percent of the net weight of the batch from a batch of medical marijuana extract derived from a system utilizing carbon dioxide for, at minimum:

(a) Pesticide and fertilizer residue; and

(b) Cannabinoid potency for, at a minimum:

(i) Delta-9-tetrahydrocannabinolic acid (THCA);

(ii) Delta-9-tetrahydrocannabinol (THC);

(iii) Cannabidiolic acid (CBDA);

(iv) Cannabidiol (CBD); and

(v) Canabinol (CBN);

(c) Mycotoxin contamination; and

(d) Heavy metal contamination including, at a minimum, arsenic, cadmium, lead, and mercury.

(3) A sample of at least one half of one per cent of the net weight of the batch from a batch of medical marijuana extract derived from a method that does not involve the use of a hydrocarbon or carbon dioxide as a solvent for, at a minimum:

(a) Cannabinoid potency including, at minimum:

(i) Delta-9-tetrahydrocannabinolic acid (THCA);

(ii) Delta-9-tetrahydrocannabinol (THC);

(iii) Cannabidiolic acid (CBDA);

(iv) Cannabidiol (CBD); and

(v) Canabinol (CBN);

(b) Foreign matter contamination;

(c) Microbial contamination;

(d) Mycotoxin contamination;

(e) Heavy metal contamination including, at a minimum, arsenic, cadmium, lead, and mercury; and

(f) Pesticide and fertilizer residue.

(E) A testing laboratory may request additional sample material in excess of the amounts listed in this rule if necessary for completion of the required quality assurance tests.

(F) For the purposes of microbial contamination analysis, a sample provided to a testing laboratory shall be deemed to have passed if it satisfies the standards set forth in Table 9 of the "Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control" (2014) monograph.

(1) If a batch of plant material is not deemed to have passed testing for microbial contamination, that batch may be designated for extraction by hydrocarbon-based or carbon dioxide-based methods

(2) Medical marijuana extract derived from a batch of plant material not deemed to have passed testing for microbial contamination must be tested for microbial contamination prior to use in the manufacture of medical marijuana products.

(G) For the purposes of mycotoxin contamination analysis, a sample provided to a testing laboratory pursuant to this rule shall be deemed to have passed if:

(1) The total of the detected amounts, if any, of aflatoxin B1, aflatoxin B2, aflatoxin G1, and aflatoxin G2 is less than twenty micrograms per kilogram; and

(2) The detected amount, if any, of ochratoxin A is less than twenty micrograms per kilogram.

(H) For the purposes of heavy metal contamination analysis, a sample provided to a testing laboratory shall be deemed to have passed if:

(1) The detected amount of arsenic, if any, is less than 0.14 micrograms per kilogram.

(2) The detected amount of cadmium, if any, is less than 0.09 micrograms per kilogram.

(3) The detected amount of lead, if any, is less than 0.29 micrograms per kilogram.

(4) The detected amount of mercury, if any, is less than 0.29 micrograms per kilogram.

(I) For the purposes of pesticide residue analysis, a sample shall be deemed to have passed if it satisfies the most stringent acceptable standard for an approved pesticide chemical residue in a food item as set forth in Subpart C of 40 C.F.R. Part 180, as effective on September 8, 2017. A sample shall automatically be deemed to have failed if residue is detected from any pesticide not on the approved pesticide list maintained by the department, regardless of the detected level of residue.

(J) Except as provided in paragraph (G)(1) of this rule, if a sample is deemed to have failed tests for any contaminants listed in this rule, the cultivator or processor that provided the sample must immediately destroy the corresponding batch of plant material or extract or lot of medical marijuana products and document the destruction in the inventory tracking system.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:4-2-05 Testing laboratory reporting.

(A) A testing laboratory performing analysis on medical marijuana shall input the results of analysis into the inventory tracking system. The department may require a testing laboratory to submit, in portable document format (.pdf), an electronic copy of the results of analysis of any batches and lots tested to an email address specified and maintained by the department.

(B) A testing laboratory performing analysis on medical marijuana shall create a unique certificate of analysis for each batch or lot tested, which shall include, at minimum:

(1) The name and license number of the testing laboratory where the analysis was performed;

(2) The name and license number of the cultivator or processor from whom the sample was received;

(3) The registered name of the medical marijuana strain or medical marijuana product that was registered with the department;

(4) A unique batch or lot number as defined in rule 3796:1-1-01 of the Administrative Code that will match the sample of medical marijuana or medical marijuana products with a batch or lot, in order to facilitate any warnings or recalls the department deems appropriate;

(5) The date or dates on which each test was performed;

(6) A grid or table listing all tests performed, and indicating "pass" or "fail" for each, as defined in rule 3796:4-2-04 of the Administrative Code.

(7) The cannabinoid profile of the sample, including the percentage content by weight for, at minimum:

(a) Delta-9-tetrahydrocannabinol (THC);

(b) Delta-9-tetrahydrocannabinolic acid (THCA);

(c) Cannabidiol (CBD);

(d) Cannabidiolic acid (CBDA); and

(e) Cannabinol (CBN);

(8) Moisture content;

(9) Water activity;

(10) Results of analysis for foreign matter contamination;

(11) Quantitative results of analysis for microbial contamination;

(12) Quantitative results of analysis for heavy metal contamination;

(13) Quantitative results of analysis for pesticide and fertilizer residue;

(14) Quantitative results of analysis for mycotoxins;

(15) Quantitative results of analysis for residual solvents; and

(16) The signature of the laboratory manager or scientific director certifying the analysis.

(C) The certificate of analysis may contain the following:

(1) Results of quantitative analysis of additional cannabinoids for which the laboratory is able to obtain a standard for comparison;

(2) Results of quantitative analysis of terpenes for which the laboratory is able to obtain a standard for comparison;

(D) A certificate of analysis shall not contain any sum totals of cannabinoids or terpenes, except THC content as defined in paragraph rule 3796:1-1-01 of the Administrative Code.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:4-2-06 Testing laboratory waste disposal.

(A) Upon completion of the required analysis performed on any given sample, a testing laboratory shall immediately dispose of any medical marijuana waste or excess medical marijuana not used during the sample analysis in accordance with the testing laboratory's disposal plan and in such a manner as to render the medical marijuana unusable.

(B) The disposal procedures established by the testing laboratory and submitted as part of the application process shall be sufficient to render unusable any medical marijuana waste or excess medical marijuana not used during the sample analysis. Medical marijuana waste or excess medical marijuana that is rendered unusable shall be discarded into a locked dumpster or other approved, locked container for removal from the facility by a waste removal company selected by the testing laboratory. Medical marijuana waste or excess medical marijuana shall be rendered unusable by grinding and incorporating the medical marijuana waste with one or more of the non-consumable, solid wastes listed in this paragraph, such that the resulting mixture is at least fifty-one per cent non-marijuana waste:

(1) Paper waste;

(2) Cardboard waste;

(3) Food waste;

(4) Yard waste;

(5) Soil or other growth media;

(6) Other wastes approved by the department.

(C) The disposal of medical marijuana waste and excess medical marijuana not used during the sample analysis shall be performed by a type 1 key employee, as defined in paragraph (H) of rule 3796:5-2-01 of the Administrative Code, under video surveillance from the time the destruction begins to when it is placed in a locked dumpster or other approved, locked container and removed from the facility.

(D) The type 1 employee overseeing the disposal of excess medical marijuana shall maintain and make available in accordance with this chapter a separate record of every disposal indicating:

(1) The date and time of disposal;

(2) The manner of disposal;

(3) The volume and weight of the excess medical marijuana;

(4) The solid waste used to render the excess medical marijuana unusable; and

(5) The signature of the type 1 employee overseeing the disposal of the medical marijuana.

(E) The disposal of other waste from the testing laboratory that does not include medical marijuana, including hazardous waste and liquid waste, shall be performed in a manner consistent with federal and state law.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:4-2-07 Testing laboratory security.

(A) The department shall determine the appropriate security requirements for all testing laboratory facilities, and may require additional safeguards to ensure the security of medical marijuana. A testing laboratory shall comply with the security plan submitted as part of its testing laboratory provisional license application. At a minimum, the testing laboratory shall:

(1) Install an adequate security alarm system around the perimeter, utilizing commercial grade equipment, to prevent and detect diversion, theft, or loss of medical marijuana;

(2) Utilize a video surveillance recording system installed by a vendor that is approved by the department and that meets the standards required by the department to prevent and detect diversion, theft, or loss of medical marijuana;

(3) Maintain all security system equipment and video surveillance systems in a secure location so as to prevent theft, loss, destruction, or alteration;

(a) A testing laboratory shall limit access to surveillance areas to type 1 key employees that are essential to surveillance operations, law enforcement agencies, security system service employees, the department, and others when approved by the department; and

(b) A testing laboratory shall make available to the department, upon request, a current list of type 1 employees and contractors who have access to the surveillance room. A testing laboratory shall keep all on-site surveillance rooms locked and shall not use such rooms for any other functions.

(4) Keep all approved safes, approved vaults, or any other approved equipment or areas used for storing medical marijuana samples securely locked and protected from unauthorized access;

(5) Ensure the outside perimeter of the facility is well-lit and in accordance with the testing laboratory's plan in its license application;

(6) Restrict access to any area within the facility containing medical marijuana samples to all persons except licensed employees and agents or an individual permitted to access the facility under the supervision of a licensed employee or agent in accordance with the visitor authorization procedures set forth in rule 3796:5-2-01 of the Administrative Code.

(7) Limit the use of combination numbers, passwords, or electronic or biometric security systems to licensed, authorized employees, and prevent the sharing of any employee-specific access credentials; and

(8) Not allow keys to be left in the locks and not store or place keys or badges in a location accessible to persons other than licensed, authorized employees.

(B) The testing laboratory shall install a security alarm system and a video surveillance recording system under paragraph (A) of this rule. A security alarm system and video surveillance recording system shall, at a minimum, contain the following:

(1) A system designed to detect motion and identify unauthorized access to the facility;

(2) Video cameras in all areas that may contain medical marijuana samples, and at all points of entry and exit to capture a clear and certain identification of any person entering or exiting the facility, which shall be appropriate for the normal lighting conditions of the area under surveillance;

(3) Video cameras shall be directed at all approved safes, approved vaults, any other area where medical marijuana samples are being stored or handled;

(4) The security alarm system and video surveillance recording system shall comply with the following minimum capabilities:

(a) Provide a direct feed and login capabilities to the department to allow for real-time access and monitoring of the facility via the live video surveillance recording system.

(b) A display monitor with a minimum screen size of twelve inches shall be connected to the electronic recording security system at all times.

(c) Installed in a manner that will prevent cameras from being readily obstructed, tampered with, or disabled.

(d) The ability to immediately produce a clear color still photo that is a minimum of 9600 dpi from any camera image (live or recorded).

(e) A date and time stamp embedded on all recordings. The date and time shall be synchronized and set correctly and shall not significantly obscure the picture.

(f) Cameras installed outdoors and in low-light interior areas shall be day/night cameras with a minimum resolution of six hundred lines per inch (analog) or D1 (IP) and a minimum light factor requirement of 0.7 LUX. The installation of additional lighting may be required to increase picture clarity and brightness. Cameras shall be calibrated and focused to maximize the quality of the recorded image.

(g) Allow for the exporting of still images in an industry standard image format, including .jpg, .bmp and .gif. Exported video shall have the ability to be archived in a proprietary format that ensures authentication of the video and guarantees that no alteration of the recorded image has taken place. Exported video shall also have the ability to be saved in an industry standard file format that can be played on a standard computer operating system. All recordings shall be erased or destroyed prior to disposal.

(h) Security recordings shall provide an image resolution of at least D1, and the image frame rate shall be at least three frames per second during alarm or motion based recording.

(i) Repair and/or replace any failed component of the video surveillance recording system within twenty-four hours, unless notice is provided to the department and an extension is approved.

(5) Twenty-four hour live feed with motion-activated recording capabilities from all video cameras, which the testing laboratory shall make available for immediate viewing by the department upon request and shall retain for at least forty-five days. If a testing laboratory is aware of a pending criminal, civil or administrative investigation, or legal proceeding for which a recording may contain relevant information, the testing laboratory shall retain an unaltered copy of the recording until the investigation or proceeding is closed or the entity conducting the investigation or proceeding notifies the testing laboratory manager that it is not necessary to retain the recording;

(6) A silent alarm, which can be utilized in the event of a holdup or other instances of duress, which notifies law enforcement;

(7) Panic alarm, which for purposes of this subsection means an audible security alarm system signal generated by the manual activation of a device intended to signal a life threatening or emergency situation requiring a law enforcement response;

(8) Automatic voice dialer, which for purposes of this paragraph means any electrical, electronic, mechanical, or other device capable of being programmed to send a prerecorded voice message, when activated, over a telephone line, radio or other communication system, to a law enforcement, public safety, or emergency services agency requesting dispatch;

(9) A failure notification system that provides an audible, text, or visual notification of any failure in the surveillance system. The failure notification system shall provide an alert to the testing laboratory within five minutes of the failure, either by telephone, email, or text message; and

(10) The ability to comply with the security requirements of this rule for a period of at least forty-eight hours during a power outage.

(C) In addition to the requirements listed in paragraph (B) of this rule, each testing laboratory shall have a back-up alarm system approved by the department that shall detect unauthorized entry during times when no employees are present at the facility and that shall be provided by a company supplying commercial grade equipment, which shall not be the same company supplying the primary security system.

(D) A testing laboratory shall keep all security equipment in good-working order and the systems shall be inspected and all devices tested on annual basis.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:4-2-08 Testing laboratory prohibited activities.

(A) A testing laboratory shall not cultivate, process, manufacture, distribute, provide, or sell medical marijuana in any form.

(B) A testing laboratory shall not permit the consumption of medical marijuana in any form on the premises.

(C) A testing laboratory shall not share a facility with a cultivator, processor, or dispensary licensed under Chapter 3796. of the Revised Code.

(D) A testing laboratory shall not falsify, change, modify, or otherwise alter in any way the results of quantitative or other analyses performed on medical marijuana samples or the corresponding certificates of analysis.

(E) A testing laboratory shall not employ any sampling methods that do not ensure that a random sample is collected for analysis, or that could provide results that are not representative of a batch or lot from which a sample is taken.

(F) A testing laboratory shall not prepare medical marijuana samples in such a manner as to provide results that are not representative of a batch or lot from which a sample is taken.

(G) A testing laboratory shall not store medical marijuana in quantities greater than that which is necessary to perform required analyses.

(H) A testing laboratory shall not transport medical marijuana in quantities greater than that which is necessary to perform required analyses.

(I) A testing laboratory shall not perform analyses on any medical marijuana that has not been obtained from a cultivator or processor licensed under Chapter 3796. of the Revised Code.

(J) A testing laboratory shall not perform analyses on any medical marijuana that has not been identified in the inventory tracking system.

(K) A testing laboratory shall not endorse, advertise, or make claims on behalf of any cultivator, processor, dispensary, brand or strain of medical marijuana, or brand or type of medical marijuana product.

(L) A testing laboratory shall not publish or otherwise release to the public the results of any tests performed pursuant to paragraph (D) of rule 3796:4-2-03 of the Administrative Code, except aggregated data obtained as part of a research plan that has been approved by the department.

(M) An owner, officer, board member, administrator, employee, agent, or other person who may significantly influence or control the activities of a testing laboratory shall not:

(1) Have a direct or indirect financial interest in a cultivator, processor, or dispensary licensed under Chapter 3796. of the Revised Code; or

(2) Serve as an officer, board member, administrator, employee, agent, or other person who may significantly influence or control the activities of a cultivator, processor, or dispensary licensed under Chapter 3796. of the Revised Code.

(N) A physician certified or who has applied for certification by the state of Ohio medical board under section 4731.30 of the Revised Code to recommend medical marijuana shall not:

(1) Have a direct or indirect financial interest in a testing laboratory; or

(2) Serve as an officer, board member, administrator, employee, agent, or other person who may significantly influence or control the activities of a testing laboratory.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:4-2-09 Testing laboratory record keeping requirements.

(A) Each testing laboratory shall keep and maintain upon the licensed premises for a five-year period true, complete, legible, and current books and records. All required records must be made available for inspection if requested by the department. The following records shall be maintained:

(1) Records relating to the disposal of excess medical marijuana and medical marijuana waste in accordance with paragraph (E) of this rule and paragraph (D) of rule 3796:4-2-06 of the Administrative Code;

(2) Transportation records in accordance with rule 3796:4-2-10 of the Administrative Code;

(3) Records of all samples analyzed and the corresponding certificates of analysis;

(4) Security records in accordance with paragraph (B) of rule 3796:4-2-07 of the Administrative Code;

(5) Sample inventory tracking records and sample inventory records maintained in the inventory tracking system, as well as any records maintained by the facility outside the inventory tracking system;

(6) Financial records in accordance with paragraph (C) of this rule;

(7) Employee records in accordance with paragraph (D) of this rule; and

(8) Records of any theft, loss, or other unaccountability of any medical marijuana as described in rule 3796:5-4-01 of the Administrative Code.

(B) A testing laboratory may use an electronic system for the storage and retrieval of records required by Chapter 3796. of the Revised Code or the rules promulgated under Chapter 3796. of the Revised Code or other records relating to medical marijuana. Any loss of electronically-maintained records shall not be considered a mitigating factor for violations of this rule. A testing laboratory shall use a system that:

(1) Guarantees the confidentiality of the information stored in the system;

(2) Is capable of providing safeguards against erasures and unauthorized changes in data after the information has been entered and verified by the testing laboratory;

(3) Is capable of placing a litigation hold or enforcing a records retention hold for purposes of conducting an investigation or pursuant to ongoing litigation; and

(4) Is capable of being reconstructed in the event of a computer malfunction or accident resulting in the destruction of the data bank.

(C) A testing laboratory shall maintain financial records, which shall include the following:

(1) Records that clearly reflect all financial transactions and the financial condition of the business, including contracts for services performed or received that relate to the testing laboratory;

(2) Purchase invoices, bills of lading, manifests, sales records, copies of bills of sale, and any supporting documents, including the items and/or services purchased, from whom the items were purchased, and the date of purchase;

(3) Bank statements and canceled checks for all accounts relating to the testing laboratory, if applicable; and

(4) Accounting and tax records related to the testing laboratory and all investors in the facility.

(D) A testing laboratory shall maintain employee records, which shall include the following:

(1) All records relating to the hiring of employees, including applications, documentation of verification of references, and any other related materials;

(2) An employee log that includes the following information for every current and former employee:

(a) Employee name, address, phone number, and emergency contact information;

(b) Registration number and access credential designation;

(c) Date of hire and date of separation from employment, if applicable, and the reason for the separation;

(d) All training, education, and disciplinary records; and

(e) Salary and wages paid to each employee, and any executive compensation, bonus, benefit, or item of value paid to any individual affiliated with any medical marijuana entity, including members of a non-profit corporation, if any.

(E) Medical marijuana analysis and disposal records may be stored at the facility and shall include all of the following:

(1) The registered strain or product name, form, and quantity of marijuana involved;

(2) The date the sample was taken from the cultivator or processor and arrived at the testing laboratory;

(3) The date and time of testing, transporting, or disposing of the medical marijuana; and

(4) If the medical marijuana is destroyed, the testing laboratory shall maintain records in accordance with paragraph (D) of rule 3796:4-2-06 of the Administrative Code.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03

3796:4-2-10 Testing laboratory transportation of medical marijuana samples.

(A) Prior to transporting any medical marijuana samples, regardless of form, a testing laboratory licensed by the department shall maintain a transportation log, in writing, that contains the following information:

(1) The name and address of the medical marijuana entity from which the sample is taken;

(2) The name and registration number of the registered testing laboratory employee transporting the medical marijuana samples;

(3) The license plate number and vehicle type that will transport the samples;

(4) The time of departure and estimated time of arrival;

(5) The specific travel route, which includes street names and distances; and

(6) The total weight of the samples collected, a description of each sample, and the total number of samples being transported.

(B) The testing laboratory transporting medical marijuana under paragraph (A) of this rule shall enter the information required in the inventory tracking system in accordance with section 3796.07 of the Revised Code and the rules promulgated in accordance with Chapter 3796. of the Revised Code. The transportation log shall be made available to law enforcement agencies upon request. A testing laboratory shall maintain all transportation logs in accordance with the record keeping requirements established under the rules promulgated in accordance with Chapter 3796. of the Revised Code, and make them available at the request of the department.

(C) The vehicle transporting the medical marijuana samples or any product containing medical marijuana shall meet the following requirements:

(1) Be insured as required by law;

(2) Store the medical marijuana samples in a locked, safe, and secure storage compartment that is part of the motor vehicle, or in a locked storage container that has a separate key or combination pad;

(3) Ensure that any medical marijuana samples are not visible from the outside of the vehicle;

(4) Be staffed by a testing laboratory employee registered with the department;

(5) Have access to a secure form of communication with personnel at the testing laboratory and the ability to contact law enforcement through the 911 emergency system at all times that the vehicle contains medical marijuana samples, unless notification is impractical under the circumstances; and

(6) Not contain any marks, logos, brands, or other illustrations on the exterior of the vehicle, other than those affixed to the vehicle by the vehicle manufacturer or dealership.

(D) Any vehicle transporting medical marijuana samples shall travel directly from the facility from which the samples were collected to the testing laboratory, and shall not make any stops in between except to other medical marijuana entities listed on the transportation log for the purpose of collecting samples, to refuel the vehicle, or to notify the medical marijuana entities, the department and law enforcement in the event of an emergency. In the event of an emergency, the employees will report the emergency immediately to law enforcement through the 911 emergency system and to the medical marijuana entities, which will immediately notify the department, unless the notification is impractical under the circumstances.

(E) A registered testing laboratory employee transporting medical marijuana samples shall do the following:

(1) Display his or her department issued employee identification card at all times when transporting medical marijuana samples and shall produce it for the department or department's authorized representative or law enforcement official upon request;

(2) Ensure sample pick up times vary and routes are randomized;

(3) Report any vehicle accident that occurs during the transportation to the management staff of the testing laboratory within two hours after the accident occurs;

(4) Report any loss or theft of medical marijuana that occurs during the transportation of medical marijuana in accordance with rule 3796:5-4-01 of the Administrative Code; and

(5) Carry a copy of the transportation log completed pursuant to paragraph (A) of this rule for the duration of the trip.

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03