15 MAC Pt. 22, R. 3.2.2

B

Year: 2026Length: 31,118 wordsOfficial source

Cite as 15 Miss. Admin. Code Pt. 22, R. 3.2.2

B. Before renewing a license, the Department may require further information and documentation and may conduct additional background checks to determine that the licensee continues to meet the requirements of this Part. C. A licensee whose license is not renewed shall cease all operations immediately upon expiration of the license, schedule a close out inspection with the Department, and destroy all cannabis and cannabis products in the licensee’s possession in a manner approved by the Department. 3.8.4 At the time of renewal, the licensee shall ensure that all material changes to the required plans and/or standard operating procedures have been communicated in writing to the Department. 3.8.5 An inspection by the Department within sixty (60) days prior to expiration of a license issued under this Part may be required at the Department’s discretion for renewal of the license. 3.8.6 A license may be suspended, revoked, and shall not be renewed by the Department if: A. Outstanding fines are owed to the Department; B. An owner has been convicted of a disqualifying felony; C. The medical cannabis establishment has not engaged in licensed activity at the licensed premises for a period of one (1) year, unless the medical cannabis establishment submits evidence of reasonable justification, including without limitation death, illness, natural disaster, or other circumstances beyond the medical cannabis establishment’s control; D. Renewal will result in any person having a direct or indirect ownership or economic interest of greater than ten percent (10%) in more than one (1) Mississippi cannabis cultivation entity license; more than one (1) Mississippi cannabis processing entity license; and more than five (5) Mississippi cannabis dispensary licenses; E. The licensed entity owes delinquent taxes. Applicants who have completed an agreed upon payment plan and/or are following an agreed upon payment plan are not considered to be delinquent; F. The licensed entity no longer meets all eligibility requirements for the issuance of a medical cannabis establishment license; G. The licensed entity does not meet regulatory requirements set by the Department; and/or, H. The licensed entity provides of misleading, incorrect, false or fraudulent information. 3.8.7 The application for renewal of a medical cannabis establishment license may be denied after consideration by the Department of the licensee’s demonstrated history of violations of the rules in this Part. The number and severity of violations will be considered by the Department. 3.8.8 If the license of a medical cannabis establishment expires (by date), isn’t renewed, or is suspended or revoked, operations of that establishment that are authorized by rules and regulations in this Part and the MS Medical Cannabis Act must cease as instructed by the Department. 3.9 Procedure for Termination of License. 3.9.1 Licensees who permanently abandon the licensed premises or otherwise permanently cease all activities relating to the operation of a medical cannabis establishment under its license, whether a result of revocation, voluntary surrender or other reasons, shall follow the following procedures for terminating the license: A. Provide written notice of abandoning the licensed premises or ceasing operations at least forty-eight (48) hours in advance to the Department stating the reason for surrender of the license; name(s) and contact information of the person(s) responsible for closing of all business operations; and the address where business records will be retained. B. Provide the Department with a full accounting of all cannabis plants, cannabis and cannabis products located within the licensed premises; and, C. Destroy all cannabis plants, cannabis and cannabis products in its possession as instructed by the Department. The annual licensing fee paid at the time of application is non-refundable. No portion of the annual licensing fee shall be returned to the licensee. 3.10 Transfer of Ownership Requirements. 3.10.1 A licensee may transfer ownership interests, including without limitation partial ownership, only after the application for a transfer of an ownership interest has been approved by the Department. 3.10.2 An application for the transfer of ownership interests in a medical cannabis establishment shall: 1. Be completed on forms and/or a system made available by the Department; 2. Be submitted to the Department; and, 3. Contain all required supplemental information provided by the person or entity seeking to assume an ownership interest, similar to that which is required in an application for a cannabis cultivation license, to demonstrate compliance with all applicable requirements for licensure, including but not limited to fingerprinting and background check requirements. 3.10.3 The Department may revoke or suspend a license upon discovery of any effort or attempt to transfer an ownership interest in a license without complying with the requirements of this Part. 3.10.4 All information and documents required by the Department, including but not limited to, the following must accompany an application for change of ownership for a cannabis testing entity: 1. The legal name of the cannabis testing entity; 2. The name of each principal officer and board member of the cannabis testing entity; 3. An attestation that the information provided to the Department regarding the change of ownership for a cannabis testing entity is true and correct; 4. The signatures of the owners of the cannabis testing entity and the technical laboratory director and the date each signed; 5. For each owner: A. An attestation signed and dated by the owner that the owner has not been convicted of an excluded felony offense; B. An attestation signed and dated by the owner that the owner does not have a direct or indirect familial or financial relationship with or interest in a dispensary, cannabis cultivation entity, cannabis processing entity, cannabis disposal entity or cannabis research entity; and, C. An attestation signed and dated by the owner pledging not to divert cannabis to any individual or entity that is not allowed to possess cannabis; 6. Verification for each principal officer or board member that they are at least twenty-one (21) years of age. 3.11 Work Permit Licenses. 3.11.1 A medical cannabis establishment representative as defined in this Part shall register for and obtain a work permit license issued by the Department before the individual may work for, volunteer at, or maintain his/her ownership interest of ten percent (10%) or greater, whether direct or indirect, in a medical cannabis establishment licensed by the Department. 3.11.2 To be eligible to obtain a work permit, an individual shall be at least twenty-one (21) years of age. 3.11.3 An applicant for an initial work permit or renewal of a work permit shall complete a fingerprint-based background check of the Mississippi Central Criminal Database and the Federal Bureau of Investigation Criminal History Database and shall not have a disqualifying felony offense. 3.11.4 A work permit license shall be valid for five (5) years from the date of issuance by the Department. 3.11.5 A medical cannabis work permit shall be the property of the licensed individual and non-transferrable. 3.11.6 Anyone holding a valid work permit shall provide written notification to the Department within ten (10) business days of a name change. 3.11.7 All applicants for a Work Permit shall complete the application required by the Department and include all documentation set forth in this Part, pay the appropriate nonrefundable application and fingerprinting/background fees to the Department, and be approved as a valid work permit license-holder by the Department prior to beginning work at/for a medical cannabis establishment licensed by the Department or the MDOR. 3.11.8 All information and documents required by the Department, including but not limited to, the following shall accompany an initial or renewal application for a medical cannabis work permit: A. Current photograph, meeting the following requirements: 1. Clear, color photograph of the head and top of shoulders (headshot); 2. In a .jpg, .png, or .gif digital image format; 3. Taken in the last six (6) months to reflect the applicant’s appearance; 4. Taken in front of a plain white or off-white background; 5. Taken in full-face view directly facing the camera at eye level with nothing obscuring the face; 6. With a neutral facial expression and both eyes open; 7. No hat or head covering that obscures the hair or hairline, unless worn daily for a religious purpose. Full face shall be visible, and the head covering shall not cast any shadows on the face; 8. Shall not be digitally enhanced to change the appearance of the applicant (e.g., use of ā€œfiltersā€); 9. Other photo requirements as specified by the Department; B. Copy of a current driver’s license or state-issued ID card issued by the state department of motor vehicles; C. Copies of all current state issued professional licenses; D. Authorization for the Department to perform a criminal history records check; E. An attestation that the information provided to the Department to apply for a medical cannabis establishment employee work permit and registration is true and correct; F. Fees as required by the Department. 3.11.9 Application and Permit Fees: Initial and Renewal. The following nonrefundable fees are due and payable at the time of initial registration for a work permit and at the time of renewal of such permit: A. Medical Cannabis Work Permit registration fee of $25.00. B. Fingerprinting and Department background records check fee(s) in addition to the work permit registration fee. C. All payments shall be made through the Department’s electronic payment system(s) found on the Department’s website. 3.11.10 Medical cannabis establishments shall not employ any person who has been convicted of a disqualifying felony offense as defined in this Part. 3.11.11 The Department may deny an application for registration or renewal of a work permit for any of the following reasons: A. Failure to provide the information required in this Part; B. Failure to meet the requirements set forth in this Part; C. Provision of misleading, incorrect, false or fraudulent information; D. Failure to pay all applicable fees as required; and/or, E. Any other grounds that serve the purposes of this Part. 3.11.12 If the Department denies an application for registration or renewal of a work permit, the Department shall notify the applicant in writing of the Department’s decision, including the reason for denial. 3.11.13 If an individual does not complete the continuing education required by this Part, the Department may revoke the individual’s work permit or suspend the work permit until such time as the education requirements are completed. 3.11.14 The Department may fine, suspend or revoke the work permit issued by the Department for a violation of any rules and/or regulations in this Part or any disqualifying felony offense. 3.11.15 A medical cannabis work permit applicant or registered permit-holder aggrieved by a decision of the Department denying, suspending or revoking registration of a medical cannabis work permit or imposing a fine or other penalty, the applicant permit-holder may file an administrative appeal in writing with the Department within twenty (20) days of receipt of the initial notice of the decision. If an applicant permit-holder fails to appeal within twenty (20) days of receipt of the initial notice, the Department’s decision becomes final. 3.11.16 The hearing decision of the Department on the denial of an application for registration or renewal of a work permit, or the revocation or suspension of a work permit, is a final decision of the Department. Any person or entity aggrieved by a final decision of the Department under the provisions of this Part may petition for judicial review of the decision as provided in Miss. Code § 41-137-59. Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67. Subpart 4 Operational & Recordkeeping Requirements 4.1 General. 4.1.1 All medical cannabis establishments, including cannabis testing facility laboratory operations, shall be physically located within the State of Mississippi. 4.1.2 Licensed medical cannabis establishments may produce and possess usable medical cannabis in an amount reasonably necessary to meet the demand for and needs of qualifying patients as demand and needs may be determined by the Department. At a minimum, the Department will utilize the following data sources to make such determinations: patient registry, medical cannabis establishment licensing data, and data produced by the statewide seed-to-sale system. 4.1.3 Cannabis processing entities that process edible cannabis products shall also comply with any and all Department regulations for Mississippi Food Manufacture and Sale with fees and inspection schedules associated with risk level 4 for the related manufactured food permit. 4.1.4 Commencement of Operations. Medical cannabis licensees shall notify the Department (in a format approved by the Department) of their intent to commence operations for which authority is granted by the licensure status, along with the date of the commencement. Notification to the Department shall include, but is not limited to: A. Verification of an operational alarm and video surveillance system meeting requirements in Rules 4.5.2 and 4.5.3; B. Verification of secure locks throughout the facility; C. Verification of implementation of biosecurity measures; D. Verification of access controls throughout the facility; E. Verification of initial inventory of cannabis and/or cannabis products; F. Verification of functional operation capacity; G. Verification of employment records (at the time); and, H. Verification of connection to the state’s seed-to-sale system. 4.1.5 A medical cannabis licensee that fails to maintain operations for any reason for more than six (6) months from the date of licensure after it has commenced business activities shall be notified in writing and given thirty (30) days from the date of notification from the Department to submit a written explanation why it so failed and, if it plans on continuing to operate as a licensee, a description of how it will correct the problem and prevent it from occurring again. 4.1.6 Licensed medical cannabis establishments shall only purchase, grow, cultivate, and use cannabis that is grown, cultivated, processed, and dispensed in this state. No medical cannabis that is grown, cultivated or processed in this state shall be transported outside of this state. No cannabis product shall be brought into the State of Mississippi for the purpose of converting, transforming, chemically engineering, or otherwise altering it into a compound or substance which would constitute cannabis and/or a cannabis product under this Part. 4.1.7 Medical cannabis establishments shall not acquire, possess, store, grow, cultivate, harvest, manufacture, produce, or transport cannabis or cannabis products for any person or entity other than those authorized by this Part. 4.2 Personnel. 4.2.1 An individual shall not begin work at a medical cannabis establishment until after he or she obtains a work permit license issued by the Department. An individual is required to renew his or her permit every five (5) years. 4.2.2 Medical cannabis establishments shall complete a criminal history background check on each employee to verify that the employee does not have a disqualifying felony. 4.2.3 Medical cannabis establishments shall ensure that any and all persons who are employed by, volunteer for, and/or engaged in activities or operations under the direction of the licensee are qualified to perform their assigned duties. 4.2.4 All employees of a medical cannabis establishment shall be entered into the state’s seed-to-sale system within seven (7) calendar days of employment by the licensed entity. 4.2.5 A cannabis testing entity shall not employ an individual who also is employed or has ownership at any other medical cannabis establishment other than a licensed cannabis transportation entity. Further, when a cannabis testing entity owns a transport entity or any part thereof, the transport entity cannot have any ownership that creates a conflict of interest. 4.2.6 Test samples shall only be collected and transported by qualified lab employees Test samples shall not be transported between facilities in the same vehicle at the same time as any other cannabis product (e.g. retail-ready cannabis products) due to the potential for cross-contamination. 4.2.7 Cannabis testing entities shall employ a full-time supervisor or management employee who shall be responsible for the following: A. Overseeing and directing the scientific methods of the cannabis testing facility; B. Ensuring that the cannabis testing facility achieves and maintains a cannabis testing facility quality assurance program; and, C. Providing ongoing and appropriate training to cannabis testing facility employees. D. To be considered qualified, the supervisor or management employee shall have at minimum: 1. A doctoral degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university; 2. A master’s degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university, plus at least 2 years of full-time practical experience; 3. A bachelor’s degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university, plus at least 4 years of full-time practical experience; or 4. A bachelor’s degree in any field from an accredited college or university, plus at least 8 years of full-time practical experience, four (4) years of which shall have been in a supervisory or management position. 4.2.8 Cannabis testing entities shall employ a full-time analyst who, at minimum shall have: A. Earned a master’s degree or a bachelor’s degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university; or B. Completed two (2) years of college or university education that included coursework in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university, plus at least 3 years of full- time practical experience; and C. Demonstrated the analyst’s ability to perform a preparation and/or analytical method through: 1. A documented training program that includes a training checklist that is signed by the trainer and the analyst; and 2. A documented attestation that the analyst has read and understands the methods Standard Operating Procedure. D. Demonstrated an initial display of competency prior to analyzing any compliance sample. An initial display of competency for a method includes: 1. Obtaining quality control samples from an outside source or preparing the samples using stock standards that are prepared independently from those used in instrument calibration. 2. Preparing four (4) aliquots at the concentration specified, or if unspecified, to a concentration of one (1) to four (4) times the LOQ for low-concentration analytes either concurrently or over a period of days. For higher-concentration analytes (such as potency), the concentration may be greater than four (4) times the LOQ. 3. Analyzing the aliquots either concurrently or over a period of days. 4. Using all results, assess the results against established and documented method acceptance criteria. E. Complete a continuing demonstration of competency annually thereafter for all methods performed. One of the following options shall be performed and documented: 1. Another initial demonstration of competency (as described above), or 2. Participation in a proficiency test study offered by an ISO/IEC 17043 proficiency test provider (if available); or 3. Analysis of one (1) sample of clean matrix that is fortified with a known quantity of the target analyte, with the result compared to method acceptance criteria. F. If an analyst has not run a specific analysis within one calendar year, he or she shall successfully complete an initial display of competency for this analysis and shall not run such analysis until competency has been demonstrated. G. If a method Standard Operating Procedure is significantly amended, an analyst must be retrained on the procedure, and the training documented. 4.2.9 Cannabis testing facilities entities shall employ designated sample collector who, at minimum, shall have: 1. Documented attestation that the designated sample collector has read and understands the Sampling Standard Operating Procedure; 2. A documented sampling training program that includes principles, procedures, and policies of sampling and was provided by a qualified instructor who has demonstrated competency in performing the sampling methods referenced with all training documented on a training checklist for each sample matrix type that will be collected; 3. At least 8 hours of documented field training on various sampling techniques with a qualified instructor; 4. Documentation of an initial demonstration of capability (IDOC) through the comparison of replicate samples within a defined Relative Standard Deviation (%RSD) or the comparison of a sample collected to that of one collected by personnel with an existing IDOC within a defined RPD; 5. Thereafter, continuing demonstration of capability (CDOC) is required annually. The cannabis testing entity shall have a documented procedure for performing the CDOC. The cannabis testing entity shall retain documentation verifying CDOC for each designated sample collector and make this documentation available to the Department upon request; and, 6. If the Sampling SOP is significantly amended, all designated sample collectors shall be retrained on the procedure, and the training documented. 4.2.10 A cannabis testing entity must maintain a master of list of all controlled quality system documents and a signature log that includes the names, initials and signatures for all individuals who are responsible for signing or initialing any cannabis testing entity record. 4.2.11 Each licensed medical cannabis establishment is required to create an identification badge for its representatives/employees. This badge shall be conspicuously worn by all representatives /employees at all times while they are on the licensed premises or during transport of cannabis and/or cannabis products. Representatives/employees shall also maintain a copy of the Department issued work permit on their person while present at a medical cannabis establishment. 4.2.12 Within thirty (30) calendar days of the date of hire, licensed medical cannabis establishments shall ensure all employees are trained in at least the following for a minimum of eight (8) hours of initial training and five (5) hours of annual training: A. The rules and regulations contained in this Part; B. The use of security measures and controls that have been adopted by the facility for the prevention of diversion, inversion, theft, or loss of cannabis and/or cannabis products; C. Proper use of the statewide seed-to-sale system; D. Response to an emergency, including severe weather, fire, natural disasters, and unauthorized intrusions; and, E. The facility’s safety and sanitation procedures. 4.2.13 Medical cannabis licensees shall take reasonable measures and precautions to ensure the following measures for personnel: A. Disease control. Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of cannabis, cannabis products, components, contact surfaces, or packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected, unless conditions such as open lesions, boils, and infected wounds are adequately covered (e.g., by an impermeable cover). Personnel shall be instructed to report such health conditions to their supervisors. B. Cleanliness. All persons working in direct contact with cannabis, cannabis products, components, contact surfaces, and packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of cannabis or cannabis products. The methods for maintaining cleanliness include: 1. Wearing outer garments suitable to the operation in a manner that protects against allergen cross-contact and against the contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials; 2. Maintaining adequate personal cleanliness; 3. Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate handwashing facility before starting work, after each absence from the workstation, and at any other time when the hands may have become soiled or contaminated; 4. Removing all unsecured jewelry and other objects that might fall into cannabis, cannabis products, components, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which cannabis, cannabis products, or components are manipulated by hand. If such hand jewelry cannot be removed, it may be covered by gloves or material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the cannabis, cannabis products, components, contact surfaces, or packaging materials; 5. Maintaining gloves, if they are used in handling cannabis, cannabis products, or components, in an intact, clean, and sanitary condition; 6. Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints; 7. Storing clothing or other personal belongings in areas other than where cannabis, cannabis products, or components are exposed or where equipment or utensils are washed; 8. Confining the following to areas other than where cannabis, cannabis products, or components may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco; and 9. Taking any other necessary precautions to protect against allergen cross contact and against contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials with microorganisms or foreign substances (including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin). C. Responsibility for ensuring compliance by individuals with the requirements of this subchapter shall be clearly assigned to supervisory personnel who have the education, training, or experience (or a combination thereof) necessary to supervise the production of clean and safe cannabis and/or cannabis products. 4.2.14 Licensees shall not permit the consumption of cannabis and/or cannabis products on its licensed premises or by employees during working hours. 4.2.15 Contractors and Other Authorized Visitors. A. Contractors and other authorized visitors permitted access to a licensee’s premises who will not handle cannabis plants, cannabis or cannabis products, including but not limited to electricians, plumbers, engineers and alarm technicians, do not require an individual identification card issued by the licensed medical cannabis establishment. B. A contractor may enter a limited access area only if wearing a visitor identification badge, signed in and recorded on a visitor entry log and prevented from accessing cannabis plants, cannabis or cannabis products. 1. If the contractor is working in an area with immediate access to cannabis plants, cannabis or cannabis products, a licensee or employee shall supervise the contractor at all times. 2. If the contractor is working in an area in which locked doors, compartments or other physical security measures prevent the contractor from accessing cannabis plants, cannabis or cannabis products, a licensee or employee shall take reasonable precautions to ensure that the contractor remains in such areas and does not attempt to gain access to cannabis plants, cannabis or cannabis products. C. At all times while in a limited access area, the contractor shall display in a conspicuous place on their person a visitor identification badge. 1. The visitor identification badge shall display an identifying mark, which may be a clearly identifiable letter, number or symbol or combination thereof. 2. The visitor identification badge may be displayed on a sticker, a card on a lanyard, a card pinned to the clothing of the visitor, or by other effective means. D. A visitor entry log shall include, at a minimum: 1. The date and time of the visitor’s entry; 2. The date and time of the visitor’s departure; 3. The full name of the visitor; 4. The identifying number of the visitor’s state- or federally-issued identification; 5. The identifying mark on the visitor identification badge; 6. The individual identification card number of the person who will accompany the contractor, if required, while the contractor is in the limited access areas of the premises; and, 7. The purpose for which the contractor is accessing the limited access area(s). E. Any incident of noncompliance with the licensee’s authorized conduct that occurred while the contractor or visitor was in a limited access area of the premises shall be reported in writing to the Department within twenty-four (24) hours, including all information required by the visitor entry log. 4.3 Facility and Grounds. 4.3.1 Medical cannabis establishments may be located in any area in a municipality or county that is zoned as agricultural or industrial or for which agricultural or industrial use is otherwise authorized or not prohibited, provided that it being there does not violate any other provision of this Part. 4.3.2 Medical cannabis establishments may be located in any area in a municipality or county that is zoned as commercial or for which commercial use is otherwise authorized or not prohibited, provided that the municipality or county has authorized the entity to be located in such area and that it being there does not violate any other provision of this chapter. The municipality or county may authorize this by granting a variance to an existing zoning ordinance or by adopting a change in the zoning ordinance that allows for those entities to be located in specific commercial areas. 4.3.3 A municipality or county may require a medical cannabis establishment to obtain a local license, permit or registration to operate, and may charge a reasonable fee for the local license, permit or registration, provided that this fee is consistent with fees charged to businesses that are not involved in the cannabis industry. 4.3.4 No individuals may reside at the same address and/or live on the same property where a medical cannabis establishment is located. Should a prospective owner of a medical cannabis establishment reside on an adjoining property, a separate address for the medical cannabis establishment shall be obtained from the county (e.g., 123 County Road and 123 A County Road). The medical cannabis establishment shall have a separate, independent address from any residential premises. 4.4 Facility Construction and Design. 4.4.1 All commercial cannabis activities shall take place in indoor, enclosed, locked and secure facilities with controls over environmental conditions such as humidity, temperature, and light and that preclude unfiltered air exchange with the outdoors. Condition changes outside of the facility should not significantly alter or affect environmental conditions inside the facility Outdoor cultivation of cannabis and processing of cannabis products are prohibited. ā€œHome growā€ of cannabis is prohibited. 4.4.2 Indoor, enclosed, and secure facilities. All operations and activities shall take place within a building or secure structure that meets all state and local electrical, fire, plumbing and building codes and specification(s) in addition to the following requirements: A. Has a complete roof enclosure supported by connecting permanent walls, constructed of solid materials extending from the ground to the roof; that: 1. Provides a sealed environment that prevents unfiltered air exchange with the outdoors; 2. Provides control over the environment (i.e., temperature, humidity, light, carbon dioxide levels, etc.); and, 3. Protects commercial cannabis activities from all external elements; B. Is secure against unauthorized entry; C. Has a foundation, slab, or equivalent base to which the floor is securely attached; D. Has commercial-grade door locks on all external doors that are locked at all times; E. Restricts access to only authorized personnel to locked and secure areas identified with signage and daily records of entry and exit; F. Plumbing is adequate to carry sufficient quantities of water to locations through the facility and convey sewage and waste from the facility without cross-contamination of potable water and waste; G. Water supplies should be sufficient for commercial cannabis activities; H. Toxic cleaning compounds, sanitizing agents, solvents, and pesticides shall be identified and stored in a manner that is in accordance with applicable local, state or federal law, rule, or regulation; and, I. A pest control management plan shall be implemented on the premises; J. Biosecurity measures shall be implemented and adhered to at all times. 4.4.3 Cannabis facilities shall be constructed in such a manner that: A. Ensure floors, walls, and ceilings may be adequately cleaned, kept clean, and kept in good repair; B. Prevent drip or condensate from fixtures, ducts, and pipes from contaminating cannabis, cannabis products, components, contact surfaces, or packaging materials; and C. Ensure Aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating cannabis, cannabis products, components, contact surfaces, or packaging materials with clothing or personal contact; D. Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where cannabis, cannabis products, or components are examined, produced, packed, or stored and where equipment or utensils are cleaned; E. Provide shatter-resistant light bulbs, fixtures, skylights, or other glass suspended over exposed cannabis, cannabis products, or components in any step of preparation, or otherwise protect against contamination in case of glass breakage; F. Provide adequate ventilation or control equipment to minimize dust, odors, and vapors (including steam and noxious fumes) in areas where they may cause allergen cross contact or contaminate cannabis, cannabis products, or components; G. Ensure fans and other air blowing equipment are located and operate in a manner that minimizes the potential for allergen cross-contact and for contaminating cannabis, cannabis products, components, contact surfaces, and packaging materials; and, H. Provide adequate screening or other protection against pests. 4.4.4 The perimeter of all licensed medical cannabis establishments shall be designed and maintained to discourage theft and diversion of cannabis and/or cannabis products. In addition to any local zoning requirements, all cannabis licensees shall: 1. Maintain adequate lighting to facilitate video surveillance at all times (24 hours per day/7 days per week); 2. Have landscaping that prevents the concealment of any person(s) from sight or video surveillance; 3. Have fencing that ensures secure perimeter access and points of entry onto the premises including but not limited to around the grounds and that all stages of commercial cannabis activities are inaccessible to and hidden from view of the public. Licensed testing entities are exempt from this requirement. 4. Post signage in a conspicuous location at each entrance of the cannabis cultivation facility that reads ā€œPERSONS UNDER 21 YEARS OF AGE NOT PERMITTED ON THESE PREMISESā€; and, 5. Post signage in a conspicuous location at each entrance of the cannabis facility that reads ā€œTHESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCEā€. 4.4.5 Cannabis cultivation licensees shall maintain physical access to their stock of cannabis plant(s) for safe and easy observation and inventory of each plant group. Aisles shall be open and accessible so as to allow inspection of the plants by the Department and shall provide a safe means for access and viewing of plants if plants are located/placed on an upper rack. 4.4.6 Separation of Functions. If a medical cannabis establishment is licensed as a cultivation entity and processing entity with both functions in the same physical space, there shall be physical separation between the two by connecting permanent walls, constructed of solid materials extending from the ground to the roof with separate means of entrance and exit. 4.5 Security and Surveillance. 4.5.1 Licensees shall designate a security manager with responsibility for overall facility security to include, but not limited to: adherence to security requirements; conducting semiannual audits of security measures to identify areas of needed improvements/corrective actions; employee training on security measures and controls; and, prevention of diversion/theft of cannabis and/or cannabis products. 4.5.2 Alarm Systems. All licensees and locations shall have alarm systems that meet the following: 1. Upon unauthorized entry, or attempted unauthorized entry, the alarm system shall transmit a signal directly to a central protection company or a law enforcement agency that has legal authority to respond. A designated employee of the licensee shall also be notified; 2. Provide continuous, uninterrupted coverage (24 hours/7 days) for all points of ingress and egress to the facility, including without limitation doorways, windows, loading areas; 3. Provide continuous, uninterrupted coverage (24 hours/7 days) of any room with an exterior wall, any room containing cannabis (of any type or stage of growth) and any room used for cannabis production operations and activities of any type; 4. Be equipped with failure notification systems to notify the licensee and law enforcement of any failure in the alarm system; and, 5. Have the ability to remain operational during a power outage. 4.5.3 Video Surveillance. All licensees and locations shall have video surveillance that meets the following: 1. Provide continuous, uninterrupted coverage (24 hours/7 days) for all points of ingress and egress to the facility, including without limitation doorways, windows, loading areas, and parking areas; 2. Provide continuous, uninterrupted coverage (24 hours/7 days) of any room with an exterior wall, any room containing cannabis (of any type or stage of growth), and any room used for cannabis production operations and activities of any type; 3. Digital archiving capabilities for a minimum of (120) days; 4. On-site and off-site monitoring capabilities; 5. At least one on-site display monitor, of at least twelve inches, connected to the system at all times shall be available; 6. Have the date and time embedded on all surveillance recordings without significantly obscuring the picture; and, 7. Use cameras that are capable of recording in both high and low lighting conditions. 8. Have the ability to remain operational during a power outage. 9. Licensing entities should undertake a vulnerability assessment of their standby power systems, to include: all system components and hazards likely to impact the facility, conduct a detailed accounting of what electrical devices are and are not supplied by the backup power, identify systems that should not go down during a power outage event. 10. Licensees should have a backup power system/generator for backup power supply for up to a minimum of forty-eight (48) hours for portions of the facility that should be supplied with standby power during a power interruption. Licensees should have a safe and secure location for a digital backup archiving system in the facility located in a locked and secure area to prevent any unauthorized access or theft of video/recording system monitors or video footage. 4.5.4 Upon request, licensees shall make all information related to security alarm systems and video surveillance, monitoring, and recordings available to the Department within the timeframe requested. 4.5.5 Licensed medical cannabis establishments shall notify local law enforcement and the Department of any theft, robbery, break-in, or security breach that occurs on the premises, no later than twenty-four (24) hours after the licensee first becomes aware of the event. Notice to the Department shall include at minimum a description of any property that was stolen or destroyed, and the quantity of any usable cannabis that was stolen. 4.6 Health and Safety Standards. 4.6.1 General. A. Each licensee shall ensure that all cannabis and cannabis products it dispenses are safe for use or consumption by registered patient cardholders. B. Each licensee shall comply with State and county health, safety, and sanitation laws and regulations and will be subject to unannounced inspections to confirm that no health or safety concerns are present which may contaminate the cannabis or cannabis products. 4.6.2 General Sanitation Requirements. All medical cannabis establishment licensees shall maintain sanitary conditions at their respective facilities and locations that include the following: 1. Any employee who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination for whom there is a reasonable possibility of contact with cannabis and/or cannabis products shall be excluded from any operations which may be expected to result in such contamination until the condition is resolved. 2. Hand-washing areas that are adequate and convenient to employees. Hand washing or sanitizing areas shall include running water at a suitable temperature and a sanitary towel service or suitable drying device. 3. Any person working in direct contact with cannabis and/or cannabis products shall: 1. Maintain adequate personal cleanliness; 2. Wash hands and exposed portions of his or her arms thoroughly in an adequate hand-washing area before starting work and at any other time when the hands may have become soiled or contaminated, including but not limited to: a. Any time after handling possibly soiled equipment or utensils; b. After leaving the initial room in which he or she was working, and before resuming work in any room, including the initial room; D. Litter and waste shall be properly removed so they do not contribute to potential sources of contamination in areas where cannabis plants or products are located; E. Floors, walls, and ceilings shall be adequately cleaned and kept in good repair; and, F. There shall be adequate screen or other protection against the entry of pests. 4.6.3 Sanitary Operations. A. General maintenance. Buildings, fixtures, and other physical facilities shall be maintained in a clean and sanitary condition and shall be kept in repair adequate to prevent cannabis or cannabis products from becoming contaminated. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against allergen cross-contact and against contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials. B. Substances used in cleaning and sanitizing; storage of toxic materials. Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesirable microorganisms and shall be safe and adequate under the conditions of use. Compliance with this requirement may be verified by any effective means, including purchase of these substances under a letter of guarantee or certification or examination of these substances for contamination. Only the following toxic materials may be used or stored in a medical cannabis production center: 1. Those required to maintain clean and sanitary conditions; 2. Those necessary for use in laboratory testing procedures; 3. Those necessary for facility and equipment maintenance and operation; and, 4. Those necessary for use in the facility’s operations. C. Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified and stored in a manner that protects against contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials. D. Pest control. Pests shall not be allowed in any area of a production center. Guard, guide, or pest-detecting dogs may be allowed in some areas of a production center if the presence of the dogs is unlikely to result in contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials. Effective measures shall be taken to exclude pests from the production and storage areas and to protect against the contamination of cannabis, cannabis products, or components on the premises by pests. The use of pesticides to control pests in the production center is permitted only under precautions and restrictions that will protect against the contamination of cannabis, cannabis products, components, contact surfaces, and packaging materials. E. Sanitation of contact surfaces. All contact surfaces, including utensils and contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against allergen cross-contact and against contamination of cannabis, cannabis products, or components. 1. Contact surfaces used for producing and storing cannabis or low-moisture cannabis products or components shall be in a clean, dry, sanitary condition before use. When the surfaces are wet cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use. 2. In wet processing, when cleaning is necessary to protect against allergen cross contact or the introduction of microorganisms into cannabis, cannabis products, or components, all contact surfaces shall be cleaned and sanitized before use and after any interruption during which the contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and contact surfaces of the equipment shall be cleaned and sanitized as necessary. 3. Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) shall be stored, handled, and disposed of in a manner that protects against allergen cross-contact and against contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials. F. Sanitation of non-contact surfaces. Noncontact surfaces of equipment used in the operation of a production center shall be cleaned in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of cannabis, cannabis products, components, contact surfaces, and packaging materials. G. Storage and handling of cleaned portable equipment and utensils. Cleaned and sanitized portable equipment with contact surfaces and utensils shall be stored in a location and manner that protects contact surfaces from allergen cross-contact and from contamination. 4.6.4 Sanitary Facilities and Controls. Each medical cannabis establishment shall be equipped with adequate sanitary facilities and accommodations including: A. Water supply. The water supply shall be adequate for the operations intended and shall be derived from an adequate source. Any water that contacts cannabis, cannabis products, components, contact surfaces, or packaging materials shall be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the production of cannabis and cannabis products, for the cleaning of equipment, utensils, and packaging materials, or for employee sanitary facilities; B. Plumbing. Plumbing shall be of adequate size and design and adequately installed and maintained to: 1. Carry adequate quantities of water to required locations throughout the facility; 2. Properly convey sewage and liquid disposable waste from the facility; 3. Avoid constituting a source of contamination to cannabis, cannabis products, components, water supplies, equipment, or utensils or creating an unsanitary condition; 4. Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; and 5. Provide that there is not backflow from, or cross-connection between, piping systems that discharge wastewater or sewage and piping systems that carry water for cannabis or cannabis product production; C. Sewage disposal. Sewage shall be disposed of into an adequate sewerage system or disposed of through other adequate means; D. Toilet facilities. Licensees shall provide employees with adequate, readily accessible toilet facilities. Toilet facilities shall be kept clean and shall not be a potential source of contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials; E. Hand-washing facilities. Licensees shall provide hand-washing facilities designed to ensure that an employee’s hands are not a source of contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature; and rubbish disposal. Rubbish shall be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of cannabis, cannabis products, components, contact surfaces, packaging materials, water supplies, and ground surfaces. 4.6.5 Each production area designated and/or used for commercial cannabis activities shall be maintained free of debris. 4.6.6 Potable water sources shall be utilized in processing/ manufacturing of cannabis and/or cannabis products. 4.7 Extraction/Processing. 4.7.1 Cannabis processing licensees may utilize chemical extraction processes using a nonhydrocarbon-based, or other solvent such as water, vegetable glycerin, vegetable oils, animal fats, steam distillation, food-grade ethanol. Nonhydrocarbon-based solvents shall be food grade. 4.7.2 Cannabis processing licensees may use chemical extraction processes using hydrocarbon-based solvents that are at least ninety-nine percent (99%) purity. 4.7.3 Extraction processes shall take place in an environment with proper ventilation, controlling all sources of ignition where a flammable atmosphere is, or could be, present. 4.7.4 Cannabis processing licensees are prohibited from using pressurized canned flammable fuel such as butane intended for use in outdoor/camp like activities, handheld torch devise, refillable cigarette letters, etc. 4.7.5 Cannabis processing licensees using carbon dioxide shall have equipment and facilities approved by local fire code officials, if applicable. 4.7.6 Manufacturing processes using flammable gas or flammable liquid shall have leak or gas detection measures, or both. 4.8 Storage of Cannabis and/or Cannabis Products. 4.8.1 Storage of cannabis, cannabis products, and components shall be under conditions that will protect against allergen cross-contact and against biological, chemical (including radiological), and physical contamination of cannabis, cannabis products, or components as well as against deterioration of the cannabis, cannabis product, or component and the container. 4.9 General Recordkeeping Requirements. 4.9.1 Medical cannabis establishments shall participate in and utilize the state’s seed- to-sale system for inventory control and tracking purposes. All associated costs for their participation are the financial responsibility of the medical cannabis establishments. 4.9.2 Medical cannabis establishments are required to maintain the following for a minimum period of five (5) years: 1. All books and records necessary to fully account for each business transaction conducted under its license; 2. A copy of each transportation manifest for each transport of cannabis and/or cannabis products shall be maintained (a separate license as a cannabis transportation entity is required if cannabis is being transported); 3. Employment records; 4. Record of all pesticides and chemical applications to cannabis and/or cannabis products; and, 5. Records of any theft, loss, or other unaccountability of any cannabis and/or cannabis products. 4.9.3 Records of all pesticides and chemical applications to cannabis plants and/or cannabis products shall include the following: 1. The date of application; 2. The name of the individual making the application; 3. The product that was applied; 4. The section, including the square footage, that receives the application; 5. The amount of product that was applied; and, 6. A copy of the label of the product that was applied. 4.9.4 All records shall be maintained on-site or electronically (virtually) and available for Department review at the address of the licensee. 4.9.5 All cannabis plants, cannabis and cannabis products shall be physically inventoried on a weekly basis and records maintained for a minimum of five (5) years. Any removal, including but not limited to disposal or destruction, of cannabis plants, cannabis or cannabis products shall be recorded. 4.10 Employment Records. 4.10.1 A medical cannabis establishment shall keep an individual employment record for all employees, including, but not limited to: 1. Full legal name and any nicknames; 2. Detailed job description; 3. Record of all training received or acquired by the employee; 4. Dates of employment; 5. Records of days and hours worked; 6. Records of time worked; and, 7. Any disciplinary actions taken. 4.10.2 Employment records shall be maintained, either electronically or in hard copy, for at least five (5) years after the employee’s last date of employment with the cannabis cultivation facility. 4.10.3 Licensees shall ensure, document, and provide to the Department upon request, documentation that each medical cannabis establishment representative, as defined by this Part, meets the requirements of the Mississippi Medical Cannabis Act, and Department regulations. 4.11 Statewide Seed-to-Sale System and Inventory Control. 4.11.1 Licensees shall use the Department-designated seed-to-sale system directly for inventory tracking or may use an approved third-party integrator for interface into the Department-designated seed-to-sale system. 4.11.2 Licensees shall identify an employee with primary responsibility for seed-to-sale tracking (e.g., seed-to-sale system administrator). 4.11.3 Licensees shall ensure that all reporting into the Department approved statewide seed-to-sale system is clear, accurate, and transparent. 4.11.4 Licensees shall ensure its inventories are properly tagged and labeled in any manner which is compatible with the state seed-to-sale tracking program for tracking purposes and such tags may include bar codes, RFID tags, NFC tags, or other equivalent system for assigning unique numbers to cannabis plants, products, and packages: A. Tags shall contain the legal name and correct license number of the licensed medical cannabis establishment. B. Prior to a cannabis plant reaching a point where it is able to support the weight of a tag (8 inches in height), a tag may be securely fastened to the stalk or other similarly situated position approved by the Department. The tag shall remain affixed for the entire life of the plant until disposal. C. Cannabis shall be continuously and properly tagged (individually or as packages) at all stages of production, including all cultivation phases and/or production steps. D. Mother plants shall be tagged before any cuttings or clones are generated therefrom. Cuttings or clones taken from the mother plant for a plant batch shall be recorded in the state seed-to-sale program as being derived from that mother plant’s tag. E. If a tag is destroyed, stolen, or falls off of a cannabis plant or package, the licensee shall ensure a new tag is placed on the cannabis plant or package and the change is properly reflected in the State seed-to-sale system. F. Licensees shall not reuse any tags that have already been affixed to any cannabis plant or cannabis products. G. Each wholesale package of cannabis and/or cannabis products shall have a tag during storage and transfer and may only contain one batch of cannabis and/or cannabis products. This is inclusive of packages awaiting testing. H. Prior to transfer, licensees shall ensure that each immature plant batch is assigned a package tag in accordance with seed-to-sale system protocol and the rules in this Part. I. Licensees’ inventory shall have a tag properly affixed to all cannabis and/or cannabis products during storage and transfer in one of the following manners: A. Individual units of cannabis product(s) shall be individually affixed with a tag; B. Cannabis products may only be combined in a single wholesale package using one tag if all units are from the same production batch. C. If any cannabis and/or cannabis products are removed from a wholesale package, each individual unit or new wholesale package shall be separately tagged. 4.11.5 All locations related to the commercial production of cannabis and cannabis products shall be distinguishable in the statewide seed-to-sale system. Locations identified in the system shall be designed and labeled in accordance with the licensee’s approved site plan and in a manner that identifies the position of inventory within the facility at all times. Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67. Subpart 5 PRODUCT TESTING AND SAFETY 5.1 General. 5.1.1 Cannabis testing entities shall test for cannabis-related analytes for which they are licensed and registered by the Department. 5.1.2 Cannabis testing entities shall develop and implement an employee training program to ensure competency of cannabis testing entity employees for their assigned function and shall document each employee’s qualifications. 5.1.3 Licensees shall not treat or otherwise adulterate a cannabinoid product, concentrate, cannabinoid extract, or extract with any non-cannabinoid additive that would increase potency, toxicity or addictive potential, or that would create an unsafe combination, with caffeine or other chemical that may increase carcinogenicity or cardiac effects. 5.1.4 All edible cannabis products shall be homogenized to ensure uniform disbursement of cannabinoids throughout the product(s). 5.1.5 Every medical cannabis establishment licensee shall comply with the testing requirements for cannabis and cannabis products in this Part. 5.2 Batch Requirements. 5.2.1 A medical cannabis establishment shall separate each harvest batch of usable medical cannabis into no larger than twenty-five pound (25 lb) harvest batch packages for testing purposes. 5.2.2 Notwithstanding Rule 5.2.1 of this section, a medical cannabis establishment may combine harvest batch packages for purposes of test sampling if intended for use by a licensed processing entity to make a cannabinoid concentrate or extract 5.2.3 A medical cannabis establishment may not combine harvest batch packages for purposes of sampling and testing for THC or CBD. 5.2.4 A medical cannabis establishment shall assign each harvest and production batch a unique batch number as defined in this Part and that unique batch number shall be: A. Documented and maintained in the licensee’s records for at least two years and available to the Department upon request; B. Provided to the individual responsible for taking samples; and C. Included on the batch label. 5.3 Sample Size, Handling, Storage and Disposal. 5.3.1 An employee of a licensed testing facility will obtain and analyze test samples only from usable medical cannabis. Cannabis products shall be sampled and tested in final form in accordance with the rules in this Part. 5.3.2 Sampling shall be conducted on-site at the cannabis cultivation or processing entity. Testing entity personnel shall have access to the entire batch for the purposes of sampling. 5.3.3 Sampling Requirements for Mandatory Testing. A. All samples must be collected, stored, and transported in a way that mitigates contamination and degradation. B. Sampling of each harvest batch or production batch shall be conducted with representative samples such that there is assurance that all harvest or process lots are adequately assessed for contaminants and that the cannabinoid profile is consistent throughout. C. For mandatory harvest/production batch sampling, the total batch weight or count to be sampled shall be verified by the testing licensee. A testing licensee shall not pull samples for mandatory testing if there is reasonable belief the full batch is not present for sampling. D. A representative sample shall be taken from each container or area holding the harvest/production batch, from the top, middle, and bottom of the total contents. E. The sampling shall be video-recorded, with the batch number stated verbally or in writing on the video at the beginning of the video and a visible time and date indication on the video recording footage. A facility employee must be present but not involved nor assisting with the sampling. The video recordings shall be maintained for 90 calendar days. 5.3.4 The maximum harvest batch package is twenty-five pounds (25 lbs). For harvest batch sampling a licensed testing entity shall take a minimum of fifteen (15) sample increments of half a gram (0.5 g) each. Additional increments may be collected to ensure that the samples obtained are representative and sufficient to perform required testing. 5.3.5 The production batch for infused cannabis products (edible, non-edible liquids, non-edible solids) shall not contain more than 150,000 units. For infused and edible cannabis products, the test sample collected by a licensed testing entity for product testing shall comply with the minimum number of units set forth below based upon the production batch size. Additional increments may be collected to ensure that the samples obtained are representative. A. 3 units for a production batch of up to 100 units. B. 6 units for a production batch of 101 to 500 units. C. 9 units for a production batch of 501 to 1000 units. D. 12 units for a production batch of 1001 to 5000 units. E. 15 units for a production batch of 5001 to 10,000 units. F. 20 units for a production batch 10,001 to 35,000 units. G. 30 units for a production batch of 35,001 to 100,000 units. H. 50 units for a production batch of 100,001 to 150,000 units. 5.3.6 For a cannabis concentrate, each sample increment taken by a licensed testing entity for product testing shall be one-quarter gram (0.25 g). The test sample collected by a licensed testing entity for product testing shall comply with the minimum number of increments set forth below based upon the production batch size. Additional increments may be collected to ensure that the samples obtained are representative. A. 12 increments for a production batch of 1 to 2 pounds. B. 15 increments for a production batch of 2.01 to 3 pounds. C. 18 increments for a production batch of 3.01 to 4 pounds. D. 23 increments for a production batch of 4.01 to 10 pounds. E. 30 increments for a production batch greater than 10 pounds. 5.3.7 A production batch of raw or infused pre-rolls shall contain no more than 150,000 units. The test sample collected by a licensed testing entity for product testing shall comply with the minimum number of increments relative to the batch size as set forth below. Additional increments may be collected at the discretion of the licensed testing entity to ensure that the samples obtained are representative. Each sample increment consists of one packaged unit. A. 2 units for a production batch of up to 50 units. B. 3 units for a production batch of 51 to 100 units. C. 4 units for a production batch of 101 to 500 units. D. 8 units for a production batch of 501 to 1500 units. E. 12 units for a production batch of 1501 to 3000 units. F. 20 units for a production batch of 3001 to 10,000 units. G. 30 units for a production batch of 10,001 units- 35,000 units. H. 50 units for a production batch of 35,001 units – 150,000 units. 5.3.8 A production batch of inhalable concentrate products shall contain no more than 150,000 units. The test sample collected by a licensed testing entity for product testing shall comply with the minimum number of increments relative to the batch size as set forth below. Additional increments may be collected at the discretion of the licensed testing entity to ensure that the samples obtained are representative. Each sample increment consists of one packaged unit. A. 2 units for a production batch of up to 50 units. B. 3 units for a production batch of 51 to 100 units. C. 4 units for a production batch of 101 to 500 units. D. 8 units for a production batch of 501 to 1500 units. E. 12 units for a production batch of 1501 to 3000 units. F. 20 units for a production batch of 3001 to 10,000 units. G. 30 units for a production batch of 10,001 units- 35,000 units. H. 50 units for a production batch of 35,001 units – 150,000 units. 5.3.9 A licensed testing entity shall not do any of the following: A. Desiccate samples; B. Test compliance samples without homogenization where required by the rules in this Part; or C. Select only the most desirable material from a batch or sample for testing; or D. Manipulate samples in any way that would alter the sample integrity or homogeneity of the sample. All sample increments must have the same genesis. 5.3.10 Only qualified employees/representatives of a licensed testing entity may collect and transport test samples and shall follow the testing entity’s accredited sampling and transportation policies and procedure when collecting samples for testing. A. A licensed testing entity shall prepare medical cannabis sampling policies and procedures that contain all of the information necessary for collecting and transporting samples from usable medical cannabis in a manner that does not endanger the integrity of the sample for any analysis required by this rule. These policies and procedures shall be appropriate to the matrix being sampled. B. Care shall be taken to avoid contamination of the non-sampled material. Sample containers shall be free of analytes of interest and appropriate for the analyses requested. C. A sufficient sample size shall be taken for analysis of all requested tests and the quality control performed by the testing laboratory for these tests. D. A licensed testing entity shall comply with any recording requirements for samples and subsamples in the policies and procedures and at a minimum: 1. Record the location of each sample and subsample taken. 2. Subsamples collected from the same batch shall be combined into a single sample by a laboratory prior to testing. 3. Subsamples and samples collected from different batches may not be combined. 4. Field duplicates may not be combined with the primary samples. 5. Assign a field identification number for each sample, subsample and field duplicate that have an unequivocal link to the laboratory identification number. 6. Assign a unique identification number for each test batch. 7. Have a documented system for uniquely identifying the samples to be tested to ensure there can be no confusion regarding the identity of such samples at any time. This system shall include identification for all samples, subsamples, preservations, sample containers, tests, and subsequent extracts or digestates. 8. Place the licensed testing entity identification code as a durable mark on each sample container. 9. Enter a unique sample identification number into the laboratory records. This number shall be the link that associates the sample with related laboratory activities such as sample preparation. In cases where the sample collector and analyst are the same individual, or the laboratory pre-assigns numbers to sample containers, the unique identification number may be the same as the field identification code. E. The test sample(s) shall be transported in one or more sealed containers and not be accessible while in transit. F. The vehicle a testing facility employee uses to transport medical cannabis test samples shall not bear markings or other indication that it is carrying cannabis or a cannabis product. G. All test samples shall be transported by a qualified employee of a licensed testing facility and shall not be transported in the same vehicle as other products. H. An employee of the medical cannabis establishment from which a test sample is being collected shall be physically present to observe the testing facility employee collect the test sample and ensure that the sample increments are taken from throughout the batch. I. No employee of the medical cannabis establishment from which a test sample is being collected shall assist the testing facility employee nor touch the harvest and/or production batch package or sampling equipment while the testing facility employee is obtaining the test sample. J. After test samples have been selected, both the employee of the medical cannabis establishment having the test samples collected and the employee of the testing facility shall sign and date the chain of custody form, attesting to the following sample information: 1. Product name; 2. Weight of product; 3. All products and test samples are correctly identified in the statewide seed-to-sale system; and, 4. If the test sample is obtained for a retest, the testing facility confirms that it is not accepting a test sample that is prohibited from being retested. K. The medical cannabis establishment from which the test sample is collected shall enter in the statewide seed-to-sale system the test sample that is collected by a licensed testing facility, including the date and time the test sample is collected and transferred. L. When a test sample is collected from a medical cannabis establishment for testing, that licensee shall quarantine the product that is undergoing the testing from any other product at the facility. The quarantined product may not be packaged, transferred, or sold until passing test results are entered into the statewide monitoring system. M. Any cannabis or cannabis product collected for testing shall not be transferred or sold to any person or entity other than the licensee from whom the sample was collected. This provision does not apply to a testing facility that engages another testing facility to perform certain safety tests on a subcontracted basis. N. A testing facility may collect additional sample material from the same licensee from which the original sample was collected for the purposes of completing the required safety tests as long as the requirements of this Rule are met. 5.3.11 An approved testing entity shall store each test sample under the appropriate conditions to protect the physical and chemical integrity of the sample. A. Analyzed test samples consisting of cannabis or cannabis-derived product shall be appropriately segregated, controlled, and held in a controlled access area pending destruction or other disposal. B. Any portion of a cannabis or cannabis-derived test sample that is not destroyed during analysis shall be: 1. Returned to the licensed producer who provided the sample under chain of custody; or 2. Destroyed in accordance with the disposal requirements of this Part. 5.3.12 A testing entity shall maintain the documentation required in these rules for at least five years and shall provide that information to the Department upon request. 5.4 Testing Requirements and Standards. 5.4.1 Testing Requirements for Cannabis and Cannabis Products. A. All sample increments collected must be homogenized prior to sample analyses, notwithstanding foreign material testing. B. Every harvest batch of cannabis flower shall be tested for the following prior to sale or distribution to a qualified patient or caregiver: 1. Pesticides in accordance with Rule 5.4.3 of this Part; 2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part; 3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part; 4. Heavy Metals in accordance with Rule 5.4.7 of this Part; 5. Mycotoxins in accordance with Rule 5.4.8 of this Part; 6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part; 7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; 8. Foreign material in accordance with Rule 5.4.10 of this Part. C. Every production batch of raw pre-rolls shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver, for the following prior to sale or transfer: 1. Pesticides in accordance with Rule 5.4.3 of this Part; 2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part; 3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part; 4. Heavy Metals in accordance with Rule 5.4.7 of this Part; 5. Mycotoxins in accordance with Rule 5.4.8 of this Part; 6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part; 7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; 8. Foreign material in accordance with Rule 5.4.10 of this Part. D. Every production batch of cannabinoid concentrate, and extract shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer: 1. Pesticides in accordance with Rule 5.4.3 of this Part; 2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part; 3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part; 4. Heavy Metals in accordance with Rule 5.4.7 of this Part; 5. Mycotoxins in accordance with Rule 5.4.8 of this Part; 6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part; 7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; 8. Foreign material in accordance with Rule 5.4.10 of this Part. 9. A processing entity is exempt from testing concentrates for solvents under this Rule if the processing entity: a. Did not use any solvent listed in Appendix A, Table 2 1; and, b. Solvents in Used a mechanical extraction process to separate cannabinoids from the cannabis; or c. Used only water, animal fat or vegetable oil as a solvent to separate the cannabinoids from the cannabis. E. Every production batch of infused cannabis products shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer: 1. Pesticides in accordance with Rule 5.4.3 of this Part; 2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part; 3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part; 4. Heavy Metals in accordance with Rule 5.4.7 of this Part; 5. Mycotoxins in accordance with Rule 5.4.8 of this Part; 6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part; 7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; 8. Foreign material in accordance with Rule 5.4.10 of this Part; and 9. Homogeneity. 10. Final form edible cannabis products shall meet the following additional requirements: a. Produced and sold with a standardized concentration of cannabinoids not to exceed ten milligrams (10 mg) of total tetrahydrocannabinol (THC) per serving with an allowable variance of ±10% when testing. b. Must demonstrate uniform disbursement of cannabinoids throughout the product when sampled and tested. 11. Infused non-edible products and beverages are exempt from water activity and moisture content testing. F. Every production batch of Kief shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer: 1. Pesticides in accordance with Rule 5.4.3 of this Part; 2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part; 3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part; 4. Heavy Metals in accordance with Rule 5.4.7 of this Part; 5. Mycotoxins in accordance with Rule 5.4.8 of this Part; 6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part; 7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; and 8. Foreign material in accordance with Rule 5.4.10 of this Part; and G. Every production batch of infused pre-rolls and inhalable compound concentrate products shall be tested in the final form intended for sale or distribution to a qualified patient or caregiver for the following prior to sale or transfer: 1. Pesticides in accordance with Rule 5.4.3 of this Part; 2. Water activity and moisture content in accordance with Rule 5.4.5 of this Part; 3. THC and CBD concentration in accordance with Rule 5.4.6 of this Part; 4. Heavy Metals in accordance with Rule 5.4.7 of this Part; 5. Mycotoxins in accordance with Rule 5.4.8 of this Part; 6. Microbiological contaminants in accordance with Rule 5.4.2 of this Part; 7. Terpenes, if performed, in accordance with Rule 5.4.9 of this Part; and 8. Foreign material in accordance with Rule 5.4.10 of this Part. H. Testing Standards: All compliance testing requirements by product type are summarized in Appendix D and all compliance testing requirements by final packaging are summarized in Appendix E. 5.4.2 Standards for Testing Microbiological Contaminants. A. Medical cannabis and medical cannabis products required to be tested for microbiological contaminants shall be sampled using appropriate aseptic technique and tested by a Mississippi licensed and registered cannabis testing entity for microbial impurities. B. The cannabis testing entity shall report the result of the microbial impurities testing by indicating ā€œpassā€ or ā€œfailā€ on the Certificate of Analysis. C. All cannabis products shall be deemed to have passed the microbial impurities testing if all of the following conditions are met: 1. Total coliform is not detected above 100 colony forming units/gram. 2. Shiga toxin-producing Escherichia coli is not detected in 1 gram; 3. Salmonella spp. is not detected in 1 gram; and 4. Pathogenic Aspergillus species A. fumigatus, A. flavus, A. niger, and A. terreus are not detected in 1 gram. 5. Total Yeast and Mold is not detected above 10,000 colony-forming units/gram. D. Microbial impurities testing shall include an optimized incubation period for all plating-based methods used to report total coliform and total yeast and mold results. E. If the sample fails microbial impurities testing, the batch from which the sample was collected fails microbial impurities testing and shall not be released for retail sale. F. The testing entity shall follow the protocol or product instructions provided by the equipment manufacturer, including any enrichment steps. If enrichment is recommended but not required, the enrichment shall be performed. G. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion. 5.4.3 Standards for Testing Pesticides A. Medical cannabis and medical cannabis products required to be tested for pesticides shall be tested by a Mississippi licensed, and registered cannabis testing entity approved for the analytes listed in Appendix A, Table 1. B. The cannabis testing entity shall report whether any Residual Pesticides are detected above the limit of detection (LOD) and shall report the result of the testing in ppms on the Certificate of Analysis. The cannabis testing facility shall indicate ā€œpassā€ or ā€œfailā€ on the Certificate of Analysis. C. A batch fails pesticide testing if a cannabis testing entity detects the presence of a pesticide above the action levels listed in Appendix A, Table 1 in a sample: 1. During an initial test where no reanalysis is requested; or 2. Upon reanalysis as described in Rule 5.5.1 of this Part. 5.4.4 Standards for Testing Solvents. A. Medical cannabis products required to be tested for solvents shall be tested by a Mississippi licensed, and registered cannabis testing entity approved for the analytes listed in Appendix A, Table 1. B. The cannabis testing entity shall report the result of the residual solvents testing in ppm on the Certificate of Analysis and indicate ā€œpassā€ or ā€œfailā€ on the Certificate of Analysis. C. A batch fails solvent testing if a cannabis testing entity, during an initial test where no reanalysis is requested or upon reanalysis as described in section 5.5 of this Part: 1. Detects the presence of a solvent above the action level listed in Appendix A, Table 1; or 2. Calculates a RPD of more than twenty percent (20%) between the field primary result of the sample and the field duplicate result. 5.4.5 Standards for Testing Water Activity and Moisture Content. A. Medical cannabis and medical cannabis products required to be tested for water activity and moisture content shall be tested by a currently Mississippi licensed and registered cannabis testing entity. If a sample has a water activity rate of more than 0.65 aw the sample fails except for an edible infused cannabis product. B. An edible cannabis-infused product fails water activity testing if the water activity rate of more than 0.85 aw. C. Non-edible infused products are not subject to water activity testing. D. The cannabis testing entity shall report the result of the water activity test on the COA and indicate ā€œpassā€ or ā€œfailā€ on the COA. E. If a sample has a moisture content of more than fifteen percent (15%), the sample fails. The cannabis testing entity shall report the result of the moisture content on the COA and indicate ā€œpassā€ or ā€œfailā€ on the COA. F. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion. 5.4.6 Standards for Potency (THC and CBD) Testing. A. In the preparation of samples intended for potency analysis, the testing entity may not adulterate or attempt to manipulate the total potency of the sample by any means, including by the addition of trichomes that were removed during the grinding and homogenization process. B. All flower material used for potency testing shall be representative of the product used by the end consumer and homogenized in such a way that it is representative of the way a consumer would be using the product. Kief shall not be reintroduced to the flower sample during the homogenization process. C. A licensed cannabis testing entity shall test for the following at a minimum when testing medical cannabis and medical cannabis products for potency without any corrective factor taken for moisture content: 1. Delta-8- tetrahydrocannabinol; 2. Delta-8- tetrahydrocannabinolic acid; 3. Delta-9-tetrahydrocannabinol; 4. Delta-9-tetrahydrocannabinolic acid; 5. Cannabidiol (CBD); 6. Cannabidiolic acid (CBDA); 7. THC content; 8. Cannabinol (CBN); and 9. Any other cannabinoid determined by the department. D. A cannabis testing entity shall establish a limit of quantitation of 1.0 mg/g or lower for all cannabinoids analyzed and reported. E. A cannabis testing entity shall report the result of the cannabinoid testing on the Certificate of Analysis, including, at minimum: 1. A percentage for THC, THCA, CBD, and CBDA. The dry-weight percent shall be calculated using the below equation: Dry-weight percent cannabinoid = wet-weight percent cannabinoid/(1 āˆ’ percent moisture/100); 2. A percentage for Total THC and Total CBD, if applicable; 3. Milligrams per gram (mg/g) if by dry-weight or milligrams per milliliter (mg/mL) if by volume for THC, THCA, CBD, and CBDA; 4. Milligrams per gram (mg/g) if by dry-weight or milligrams per milliliter (mg/mL) if by volume for Total THC and Total CBD, if applicable; 5. Total cannabinoid concentration shall be calculated for concentration expressed in weight: Total cannabinoid concentration (mg/g) = (cannabinoid acid form concentration (mg/g) x 0.877) + cannabinoid concentration (mg/g); 6. Milligrams per package for THC and CBD; 7. Milligrams per package for Total THC and Total CBD, if applicable; 8. Milligrams per serving for THC and CBD, if any; 9. Milligrams per serving for Total THC and Total CBD, if any and if applicable; 10. For edible cannabis products, the cannabis testing entity shall also report, the concentration in milligrams per serving (mg/serving) and milligrams per package (mg/package). 11. The results of all other cannabinoids analyzed on the COA both as a percentage and in either milligrams per gram (mg/g) if by weight or milligrams per milliliter (mg/mL) if by volume. 12. The sample shall be deemed to have passed the cannabinoid testing if the amount of THC does not exceed the limits below: a. Cannabis flower or trim potency ≤ 30% total THC; b. Cannabis tinctures, oils or concentrates ≤ 60% total THC. F. A cannabis testing entity shall report the test results and indicate an overall ā€œpassā€ or ā€œfailā€ for the cannabinoid testing on the Certificate of Analysis. G. Total THC, and/or Total CBD claimed to be present on a label shall not be considered inaccurate if the difference in percentage on the certificate of analysis is plus or minus 10.0%. H. A production batch of cannabinoid concentrate or extract fails potency testing if, based on an initial test where no reanalysis is requested or upon reanalysis, the amount of THC, as calculated pursuant to Rule 5.4.6 of this Part, between samples taken from the batch exceeds twenty percent (20%) RSD. I. The testing facility shall enter all test results into the seed-to-sale system within three (3) business days of test completion. 5.4.7 Standards for Testing for Heavy Metals. A. Medical cannabis and medical cannabis products shall be tested by a current Mississippi licensed and registered cannabis testing entity for the metals listed in Appendix A. B. A cannabis testing entity shall report the result of the heavy metals test on the Certificate of Analysis and indicate ā€œpassā€ or ā€œfailā€ on the COA. C. A batch fails metals testing if a cannabis testing entity, during an initial test where no reanalysis is requested or upon reanalysis as described in section 5.5 of this Part detects the presence of metals above the action level listed in Appendix A, Table 1. D. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion. 5.4.8 Standards for Mycotoxin Testing. A. Medical cannabis and medical cannabis products shall be tested by a Mississippi licensed and registered cannabis testing entity for the following mycotoxins: Aflatoxin B1, B2, G1, and G2 Ochratoxin A. B. A batch shall be deemed to have passed mycotoxin testing if both the following conditions are met: 1. Total of aflatoxin B1, B2, G1, and G2 does not exceed 20 µg/kg of substance, and 2. Ochratoxin A does not exceed 20 µg/kg of substance. C. A cannabis testing entity shall report the result of the mycotoxin testing on the Certificate of Analysis and indicate ā€œpassā€ or ā€œfailā€ on the COA. D. A batch fails mycotoxin testing if a cannabis testing entity, during an initial test where no reanalysis is requested or upon reanalysis as described in section 5.5 of this Part detects the presence of mycotoxins above the action level listed in Appendix A, Table 1. E. The testing facility shall enter all test results into the seed-to-sale system within three (3) business days of test completion. 5.4.9 Standards for Terpenoid Testing. A. Terpene analysis is not required. However, if terpene content is listed on product packaging or label, a terpene analysis from a Mississippi licensed and registered cannabis testing entity shall be performed to confirm the product label. B. A cannabis testing facility shall report the result of the terpenoid testing on the COA both as a percentage and in either milligrams per gram (mg/g) if by weight or milligrams per milliliter (mg/mL) if by volume. C. The terpenoid testing results on the label of any one terpenoid claimed to be present shall not be considered inaccurate if the difference in percentage on the COA is plus or minus 10.0%. D. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion. 5.4.10 Standards for Foreign Material Testing. A. Medical cannabis and medical cannabis products shall be tested by a Mississippi licensed and registered cannabis testing entity to determine whether foreign material is present. B. A cannabis testing entity shall report the result of the foreign material test by indicating ā€œpassā€ or ā€œfailā€ on the COA. C. A cannabis testing entity shall perform foreign material testing on the total representative sample prior to sample homogenization. D. When the licensed testing entity performs foreign material testing, at minimum, it shall do all of the following: 1. Examine both the exterior and interior of the dried flower sample and; 2. Examine the exterior of the cannabis product sample. E. The sample shall be deemed to have passed the foreign material testing if the presence of foreign material does not exceed: 1. One-fourth (1/4) of the total sample area covered by sand, soil, cinders, or dirt; 2. One-fourth (1/4) of the total sample area covered by mold; 3. One (1) insect fragment, 1 hair, or 1 count mammalian excreta per 3.0 grams; or 4. One-fourth (1/4) of the total sample area covered by an embedded foreign material. F. If the sample fails foreign material testing, the batch from which the sample was collected fails foreign material testing and shall not be released for retail sale. G. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion. 5.4.11 Standards for Homogeneity Testing. A. Infused cannabis products must be homogenous, with the THC and CBD content evenly distributed throughout. B. Infused cannabis products shall only be considered homogenous if the concentration of total THC and/or CBD in milligrams per serving for three (3) units from the batch is +/- 15% of the stated THC/CBD per serving. C. Each type of infused product shall be tested every six (6) months and any time the manufacturing process or ingredient(s) change. D. An infused cannabis product that fails homogeneity testing shall not be released for retail sale. All subsequent production batches of the failed item type shall undergo homogeneity testing until three (3) consecutive batches pass. E. The testing entity shall enter all test results into the seed-to-sale system within three (3) business days of test completion. F. The processor shall maintain copies of the test results for each product type for at least one (1) year after the specific item is discontinued. 5.4.12 If a testing entity is not accredited for the full scope of state-required tests, the testing facility will need to subcontract with another Department-licensed testing facility for the relevant tests needed. All subcontracted testing shall be documented in the seed-to-sale system and be transferred using appropriate transport processes and chain of custody. 5.4.13 If a testing entity performs research and development testing, the laboratory shall comply with these rules. A. Punitive action shall not be taken against a licensed medical cannabis establishment for conducting research and development testing when permitted. B. The Department may publish guidance for research and development testing that shall be followed by all licensed medical cannabis establishments. C. Research and development testing is only permitted BEFORE compliance testing for all analytes except Terpenes, which shall always be ordered as an R&D test. D. All research and development testing shall be fully completed and reported into the seed-to-sale system by the testing entity BEFORE the final compliance testing can be ordered by the licensee. E. Research and development testing shall not replace the Department’s required safety compliance testing. 5.4.14 The Department shall take immediate disciplinary action, including sanctions, fines, or both, against any testing entity that falsifies records or fails to comply with the provisions of this Part. 5.4.15 A testing entity shall comply with random compliance checks at the request of the Department. The Department or its authorized agents may collect a random sample of a medical cannabis product from a testing entity or designate another testing entity to collect a random sample of a medical cannabis product in a secure manner to test that sample for compliance pursuant to these Rules. 5.5 Failed Test Samples. 5.5.1 If a sample fails any initial test, the cannabis testing entity that did the testing may reanalyze the sample. If the sample passes, another cannabis testing entity shall resample the batch and confirm that result in order for the batch to pass testing. 5.5.2 If a sample fails a test or a reanalysis under Rule 5.5.1of this Chapter, the batch: A. May be remediated or sterilized in accordance with this subchapter; or B. If it is not or cannot be remediated or sterilized under this rule, it shall be destroyed in a manner specified by the Department. 5.5.3 If a cultivation entity is permitted under this Part to sell or transfer a harvest batch that has failed a test, the cultivation entity shall notify the processing entity to whom the harvest batch is sold or transferred of the failed test within twenty-four (24) hours of receipt of the COA. 5.5.4 Failed Microbiological Contaminant Testing. A. If a sample from a batch of usable medical cannabis fails microbiological contaminant testing, the batch may be used to make a cannabinoid concentrate or extract if the processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent, or a CO2 closed loop system. B. If a sample from a batch of a cannabinoid concentrate or extract fails microbiological contaminant testing, the batch may be further processed, if the processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent, or a CO2 closed loop system. C. A batch that is sterilized in accordance with subsection (A) or (B) of this rule shall be sampled and tested in accordance with this Chapter and must be tested, if not otherwise required for that product, for microbiological contaminants, solvents and pesticides. D. A batch that fails microbiological contaminant testing after undergoing a sterilization process in accordance with subsection (A) or (B) of this rule shall be destroyed in a manner specified by the Department. 5.5.5 Failed Solvent Testing. A. If a sample from a batch fails solvent testing, the batch may be remediated using procedures that would reduce the concentration of solvents to less than the action level. B. A batch that is remediated in accordance with subsection (A) of this rule shall be sampled and tested in accordance with this Chapter and shall be tested if not otherwise required for that product under this Chapter, for solvents and pesticides. C. A batch that fails solvent testing that is not remediated or that if remediated fails testing shall be destroyed in a manner specified by the Department. 5.5.6 Failed Water Activity Testing and Moisture Testing. A. If a sample from a batch of usable medical cannabis fails for water activity or moisture activity, the batch from which the sample was taken may: 1. Be used to make a cannabinoid concentrate or extract; or 2. Continue to dry or cure. B. A batch that undergoes additional drying or curing as described in subsection (A) of this rule shall be sampled and tested in accordance with this Part. 5.5.7 Failed pesticide testing. If a sample from a batch fails pesticide testing, the batch may not be remediated and shall be destroyed in a manner permitted under this Part and/or approved by the Department. 5.5.8 Failed Potency Testing. A. Usable medical cannabis that fails potency testing under Rule 5.4.7 of this Part may be repackaged in a manner that enables the item to meet the standard in Rule 5.4.7 of this Part. B. Usable medical cannabis that is repackaged in accordance with this section shall be sampled and tested in accordance with these Rules. 5.5.9 Failed Remediation. A. If a sample fails a test after undergoing remediation or sterilization as permitted under this rule, the batch shall be destroyed in a manner approved by the Department. B. A cultivation or processing entity shall inform a cannabis testing facility prior to samples being taken that the batch has failed a test and is being retested after undergoing remediation or sterilization. C. A cultivation or processing entity shall, as applicable: 1. Have detailed procedures for sterilization processes to remove microbiological contaminants and for reducing the concentration of solvents. 2. Document all sampling, testing, sterilization, remediation and destruction that are a result of failing a test under these rules. D. A cannabis or cannabis product batch may only be remediated twice. If the batch fails after a second remediation attempt and the second retesting, the entire batch shall be destroyed in a manner approved by the Department. E. Within one (1) business day of completing the required analyses of a representative sample obtained from a remediated cannabis or cannabis product batch, the cannabis testing entity shall upload the COA information into the seed-to-sale system. 5.6 Tentative Identification of Compounds. 5.6.1 Tentatively Identified Compounds (TICs) are compounds detected in a sample using gas chromatography mass spectrometry that are not among the target analytes for the residual solvent analysis. 5.6.2 The Department may initiate an investigation of a cultivation or processing entity upon receipt of a TICs report from a cannabis testing entity and may require a cultivation or processing entity to submit samples for additional testing, including testing for analytes that are not required by these rules, at the cultivation or processing entity’s expense. 5.7 Certificate of Analysis (COA). 5.7.1 The cannabis testing entity shall generate a Certificate of Analysis for each representative sample that the cannabis testing entity analyzes. 5.7.2 The cannabis testing entity shall ensure that the COA contains the results of all required analyses performed for the representative sample. 5.7.3 The cannabis testing entity shall, within three (3) business day of completing all analyses of a sample, upload the COA into the seed-to-sale system. Passed test results shall be in the Department’s seed-to-sale system for a batch to be released for immediate processing, packaging, and labeling for transfer or sale in accordance with these Rules. 5.7.4 The cannabis testing entity shall not release to any person any cumulative or individual test results prior to completing all analyses and providing the COA to the Department. 5.7.5 The COA shall contain, at minimum, the following information: A. The term ā€œRegulatory Compliance Testingā€ in font no smaller than 14- point, which shall appear in the upper-right corner of each page of the COA. No text or images shall appear above the term ā€œRegulatory Compliance Testingā€ on any page of the COA. B. The cannabis testing entity’s name, premises address, and license number; cultivator’s, or processor’s name, premises address, and license number; C. Batch number of the batch from which the sample was obtained. For cannabis and cannabis products that are already packaged at the time of sampling, the labeled batch number on the packaged cannabis and cannabis products shall match the batch number on the COA; D. Sample identifying information, including matrix type and unique sample identifiers; E. Sample history, including the date collected, the date received by the cannabis testing entity, and the date(s) of sample analyses and corresponding testing results; F. A picture of the sample of cannabis and cannabis products. If the sample is pre-packaged, the picture shall include an unobstructed image of the packaging; G. For dried flower samples, the total weight of the batch in grams and the total weight of the representative sample in grams; H. For cannabis product or pre-rolls samples, the total unit count of both the representative sample and the total batch size; I. Measured of the cannabis and cannabis products; J. The analytical methods, analytical instrumentation used, and corresponding Limits of Detection (ā€œLOD)ā€ and Limits of Quantitation (ā€œLOQā€); K. An attestation on the COA from the cannabis testing entity supervisory or management employee that all LQC samples required by this Part were performed and met the acceptance criteria; and, L. Analytes detected during the analyses of the sample that are unknown, unidentified, or injurious to human health if consumed, if any. 5.7.6 The cannabis testing entity shall report test results for each representative sample on the COA as follows: Indicate an overall ā€œpassā€ or ā€œfailā€ for the entire batch; A. When reporting qualitative results for each analyte, the cannabis testing entity shall indicate ā€œpassā€ or ā€œfailā€; B. When reporting quantitative results for each analyte, the cannabis testing entity shall use the appropriate units of measurement as required under this Part; C. When reporting results for each test method, the cannabis testing entity shall indicate ā€œpassā€ or ā€œfailā€; D. When reporting results for any analytes that were detected below the analytical method LOQ, indicate ā€œ<LOQā€, notwithstanding cannabinoid results; E. When reporting results for any analytes that were not detected or detected below the LOD, indicate ā€œNDā€; and, F. Indicate ā€œNTā€ for any test that the cannabis testing entity did not perform. 5.7.7 The cannabis testing entity supervisory or management employee shall validate the accuracy of the information contained on the COA and sign and date the COA. 5.7.8 The cannabis testing entity supervisory or management employee may request to amend a COA to correct minor errors and upload into the seed-to-sale system. 5.8 Post-Testing Sample Requirements. 5.8.1 The cannabis testing entity shall retain the reserve sample, consisting of any portion of a sample that was not used in the testing process. The reserve sample shall be kept at minimum, for forty-five (45) business days after the analyses, after which time it may be destroyed and denatured to the point the material is rendered unrecognizable and unusable. 5.8.2 The cannabis testing entity shall securely store the reserve sample in a manner that prohibits sample degradation, contamination, and tampering. 5.8.3 The cannabis testing entity shall provide the reserve sample to the Department upon request. 5.9 Transportation of Samples. 5.9.1 Qualified employees of a licensed cannabis testing entity are responsible for the collection and transportation of testing samples. Only qualified employees of a licensed cannabis testing entity shall collect and transport medical cannabis test samples. Medical cannabis test samples shall not be transported in the same vehicle with any other usable cannabis or cannabis products. 5.9.2 Licensed cannabis testing entities that transport medical cannabis test samples shall also comply with all applicable rules and regulations set forth in Subpart 7 of this Part. 5.9.3 Qualified employees/representatives of a licensed cannabis testing entity shall utilize an electronic inventory management system to create and maintain transportation manifests documenting all transport of medical cannabis and medical cannabis products throughout the State of Mississippi. 5.9.4 When transporting medical cannabis test samples, all cannabis testing entities and their employees/representatives shall provide copies of the inventory manifests to each originating and receiving medical cannabis establishment at the time the product changes possession. 5.9.5 The copy of the inventory manifest to be left with the originating medical cannabis establishment shall include, at a minimum: A. The license number, business name, address, and contact information of the originating medical cannabis establishment; B. A complete inventory of the medical cannabis test samples to be transported, including the quantities by weight or unit of each type of medical cannabis and medical cannabis products and the batch number(s); C. The date of transportation and the approximate time of departure; D. Printed names, signatures, and identification card numbers of testing entity personnel accompanying the transport; E. The license number(s), business name(s), address(es), and contact information for all end point recipients. 5.9.6 The copy of the inventory manifest to be left with the receiving medical cannabis establishment shall include, at a minimum: A. The license number, business name, address, and contact information for the receiving medical cannabis establishment; B. The license number, business name, address, and contact information of the originating medical cannabis establishment; C. A complete inventory of the medical cannabis test samples delivered to the receiving medical cannabis establishment, including the quantities by weight or unit of each type of medical cannabis test sample and the batch number(s); D. The date and estimated time of arrival; E. The printed names, signatures, and identification card numbers of the personnel accompanying the transport; and F. The printed names, titles, and signatures of any personnel accepting delivery on behalf of the receiving medical cannabis establishment. 5.9.7 Transportation manifests should reflect a complete chain of custody of all medical cannabis test samples being transported, including all instances in which the medical cannabis test samples are stored. 5.9.8 Originating and receiving licensed entities shall maintain copies of transportation manifests and inventory records logging the quantity of medical cannabis test samples received for at least three (3) years from the date of receipt. 5.9.9 A transportation manifest shall not be altered after departing from the originating medical cannabis establishment’s premises, except for the addition of the printed names, titles, and signatures of any personnel accepting delivery on behalf of the receiving cannabis testing entity. 5.10 Quality Assurance Measures for Cannabis Testing Entities. 5.10.1 The cannabis testing entity shall develop and implement a Quality Assurance (QA) program to assure the reliability and validity of the analytical data produced by the cannabis testing entity. The QA program shall, at minimum, include a written QA manual that addresses the following: A. Quality control procedures; B. Cannabis testing entity organization and employee training and responsibilities, including good laboratory practice (GLP); C. QA objectives for measurement data; D. Traceability of data and analytical results; E. Instrument maintenance, calibration procedures, and frequency; F. Performance and system audits, G. Corrective action procedures; H. Steps to change processes when necessary; I. Record retention and document control; J. Test procedure standardization; and K. Method validation; L. Chain of custody protocols; M. Premise and sample security; N. Sample handling, including sample receipt, identification, rejection, storage and destruction; O. Contingency plans for data that is not within control limits, or is otherwise unacceptable for analysis; and P. Disposal of cannabis and laboratory waste. 5.10.2 The supervisory or management cannabis testing entity employee shall annually review, amend if necessary, and approve the QA program and manual both when they are created and when there is a change in methods, testing entity equipment, or the supervisory or management testing entity employee. 5.10.3 The cannabis testing entity’s standard operating procedures for testing methods shall include the following: A. The name of the testing method; B. A list of all analytes used in the testing method; C. The applicable matrix or matrices; D. Sample receipt and acceptance; E. Method sensitivity; F. Potential interferences; G. Analytical instrument and equipment used; H. Consumable supplies, reagents, and standards; I. Sample preservation and hold time; J. Type, frequency, and acceptable criteria for quality control samples; K. Type, frequency, and acceptable criteria for calibration standards; L. Procedures for analyzing batch samples; M. Data quality assessment and acceptance criteria; N. Calibration of results; and, O. Reagent solution and reference material preparation. P. Current step-by-step instructions with sufficient detail to perform the assay to include equipment operation and any abbreviated versions used by a testing analyst. 5.10.4 Each cannabis testing entity shall maintain a consumables log or inventory for all reagents, reference standards and media purchased and received. All reagents and reference standards, including any working standards, must be: A. Labeled to indicate identity, batch number, date received or prepared, expiration date, and where applicable, concentration or purity, and date opened; B. Stored under appropriate conditions to minimize degradation or deterioration of the material; C. Within their expiration or re-qualification dates at the time of use; and, D. Documented on records for each analysis. 5.10.5 Each cannabis testing entity shall calibrate and maintain its equipment as specified below, and the calibration, verification and/or check and maintenance must be documented. A. Trend testing space temperatures and humidity daily using NIST-certified temperature devices. Record corrective action if temperatures are out-of- range. B. Check autoclaves performance with bioindicator monthly and use heat- indicating tape with each cycle. C. Check automatic Pipettes or Micropipettors and Pipette Tips dispensing accuracy and precision quarterly and calibrate annually. D. Check balances daily with a documented zero before use and service and recalibrate annually. E. Inspect Biosafety cabinet airflow with each use and have certified annually. F. Clean blenders as required by manufacturer after each homogenization of submitted cannabis or cannabis products. G. Verify centrifuge speeds and temperatures daily and have certified annually. H. Calibrate conductivity monthly. I. Trend freezer and refrigerator temperatures daily using NIST-certified temperature devices. Record corrective action if temperatures are out-of- range. J. Inspect glassware for chemistry cannabis testing entity with each use for cleanliness, chips, and etching with each use. Use class A when specified by the approved method and keep certificate of conformance per each piece of class A glassware. If class B or class A without a certificate of conformance, perform verification check upon purchase or prior to first use. K. Inspect glassware for microbiological cannabis testing entity with each use for cleanliness, chips, and etching. L. Trend incubator temperatures daily using NIST-certified temperature devices. Record corrective action if temperatures are out-of-range. M. Trend water bath temperatures daily using NIST-certified temperature devices. Record corrective action if temperatures are out-of-range. N. Trend Laminar Flow Hoods daily and service annually. O. Clean Microscope optics and stage daily and check alignment with each use. Service annually. P. Follow Microwave digestors manufacturer’s instructions. Q. Check Muffle furnaces temperature accuracy at least annually. R. Standardize pH meters with at least 2 buffer solutions daily before use. S. Check Spectrophotometers wavelength. T. Check Timers and stop watches at least annually. U. Certify reference weights annually. V. Follow Analytical Instrumentation manufacturer’s instructions for cleaning and maintenance and document all cleaning, calibrations, maintenance, and repairs. W. Maintain all service records for the life of equipment. 5.10.6 The cannabis testing entities shall develop, implement, and validate test methods for the analyses of samples as follows: A. To the extent practicable, methods shall compart with the following guidelines: B. The Bacteriological Analytical Manual (BAM), 2019, which is incorporated by reference, includes no future editions or amendments, and is available at https://www.fda.gov/food/laboratory-methods-food/bacteriological- analytical-manualbam; C. AOAC Official Methods of Analysis, 21st Edition, 2019, which is incorporated by reference, includes no future editions or amendments, and is available at https://www.aoac.org/official-methods-of-analysis-21st-edition- 2019; and D. To the extent practicable, methods shall be validated in accordance with the following guidelines: 1. AOAC - Appendix J: Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces, 2012, which is incorporated by reference, includes no future editions or amendments, and is available at http://www.eoma.aoac.org/app_j.pdf; 2. AOAC - Appendix K: Guidelines for Dietary Supplements and Botanicals, 2013, which is incorporated by reference, includes no future editions or amendments, and is available at http://www.eoma.aoac.org/app_k.pdf; 3. ICH – Validation of Analytical Procedures: Text and Methodology Q2(R1) 2005, which is incorporated by reference, includes no future editions or amendments, and is available at https://database.ich.org/sites/default/files/Q2_R1__Guideline.pdf or Unofficial version of the Rules in 9 A.A.C. 17, effective September 8, 2022 Page 115 https://www.fda.gov/regulatory-information/search-fda- guidance-documents/q2-r1- validation-analytical-procedures-text-and- methodology. E. Method validation should, at a minimum, verify accuracy, precision, analytical sensitivity, analytical specificity, limit of detection, limit of quantification, reportable range and the identification of interfering substances. F. Methods adopted from a matrix specific standard method, inclusivity and exclusivity do not require a comprehensive reassessment, provided that there were no modifications to the methods, including, but not limited to, all of the following: 1. Referenced media. 2. Primers. 3. Probes. 4. Antibodies. 5. Critical chemistries that were not modified. 6. Microbial methods shall include environmental monitoring and quality control of all buffers, media, primers, and incubators. G. The licensed laboratory shall generate a validation report for each test method. Each validation report shall include the following information: 1. Instrument calibration data, if any; 2. Raw data, including instrument raw data scanned as a PDF, for each test method, if any; 3. Cannabis reference materials or certified reference material results; 4. Data and calculations pertaining to LOD and LOQ determinations, if any; 5. Quality Control Sample report; 6. Worksheets, forms, pictures, or copies of laboratory notebook pages H. The laboratory director shall review, approve, sign, and date the validation report for each test method. I. Validations shall be submitted to the agency for approval with an acceptable and graded external proficiency test by a third party, where all required analytes are shown to have passed. J. Upon new test methods or altered test methods being used in the laboratory, the new validation report shall be submitted to the Department within 5 business days. 5.11 Cannabis Testing Entity Quality Control Samples. 5.11.1 The cannabis testing entity shall use Quality Control samples (QC) and adhere to good, approved laboratory practice (ā€œGLPā€) in the performance of each analysis according to the specifications of this Part. 5.11.2 The cannabis testing entity shall analyze QC samples in the same manner as the cannabis testing entity analyzes cannabis and cannabis products samples. 5.11.3 The cannabis testing entity shall use at least one negative control, one positive control, and one cannabis testing entity replicate sample in each analytical batch for each target organism during microbial testing. If one of the controls produces unexpected results, the samples shall be re- prepped and reanalyzed with a new set of controls. 5.11.4 If the result of the microbial analyses is outside the specified acceptance criteria in Appendix A, Table 2, the cannabis testing entity shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria. Microbiology Culture Methods – Qualitative and Quantitative The quality control (QC) samples that are required for culturing of cannabis and cannabis products using qualitative and quantitative methods are included in Appendix A, Table 2. Molecular Assays/Methods The QC samples that are required for molecular (i.e., polymerase chain reaction (PCR), gel electrophoresis and probe-based qPCR with or without melting curve analyses) analysis of cannabis and cannabis products are listed in Appendix A, Table 3. PCR positive DNA controls are used to verify that the PCR master mix and reagents were prepared correctly to produce amplification of the target nucleic acid. This type of positive control is analyzed with each PCR run. A PCR run is defined as a group of samples that are analyzed at the same time under the same amplification conditions, using the same PCR master mix, and in the same thermocycler. A PCR run may contain more than one extracted sample batches. A PCR run with multiple assays must have a DNA positive control for each assay. Inhibition controls are used to verify that interfering constituents from a cannabis form, which may be carried over during isolation of nucleic acids or organisms during sample processing, do not inhibit the PCR. Because cannabis forms are constantly changing, inhibition positive controls must be performed in every extracted sample. PCR DNA negative controls are used to verify that the PCR master mix and reagents were prepared correctly to produce amplification of the target nucleic acid. This type of negative control is analyzed with each PCR run. A PCR run is defined as a group of samples that are analyzed at the same time under the same amplification conditions, using the same PCR master mix, and in the same thermocycler. A PCR run may contain more than one extracted sample batches. A PCR run with multiple assays must have a DNA negative control for each assay to verify that the amplification conditions are working properly. No template controls are used to verify no contaminating nucleic acid has been introduced into the master mix. These controls are prepared when template is added to the master mix. They are prepared as separate PCR reactions to which aliquots of molecular-grade water or buffer are added to the master mix in place of target nucleic acid or sample. A negative result with this control indicates that the master mix and final processing reagents are not contaminated. This type of negative control is analyzed with each PCR run. A PCR run is defined as a group of samples that are analyzed at the same time under the same amplification conditions, using the same PCR master mix, and in the same thermocycler. A PCR run may contain more than one extracted sample batch. A PCR run with multiple assays must have not template controls for each assay to verify that the sterility of the assays. One duplicate sample is required per run. A duplicate sample is subjected to all of the same steps as the original sample. For qualitative analyses, if the duplicate sample does not equal the sample result, the sample and its duplicate must be reanalyzed. Consideration should also be given to possibility of re-preparing and reanalyzing all associated samples. For quantitative analyses, if the RPD of the sample and duplicate is greater than 100, the parent sample and duplicate sample must be reanalyzed. Consideration should also be given to possibility of re- preparing and reanalyzing all associated samples. When data are accepted, the result for the sample portion designated as the ā€œoriginal sampleā€ is reported. 5.11.5 Chemistry – Analytical, Organic and Inorganic (Metals). Quality control must be performed for each analytical, organic and metal chemistry method. Each cannabis testing entity shall maintain sufficient raw data records to ensure the QC was performed at the frequency specified. ā€˜Bracketing’ of QC samples, rotating from across the calibration curve range, is required. QC samples must follow the first twenty (20) samples after an initial calibration, every twenty (20) samples thereafter, and at the end of testing samples. This would also apply to a continuing calibration. Initial Calibration A. Samples results must be associated with an acceptable initial calibration. If the initial calibration is not acceptable, corrective actions must be performed and all associated samples re-analyzed. B. No sample results are to be reported nor data qualified for a failed initial calibration. C. Samples must be analyzed under an initial calibration that was performed no more than one month prior. D. The following items are required elements of an initial calibration: 1. The details of the initial calibration procedures including calculations, integrations, acceptance criteria, and associated statistics must be included or referenced in the method SOP. When initial calibration procedures are referenced in the method SOP, then the referenced material must be retained by the cannabis testing entity and be available for review; 2. Sufficient raw data records must be retained to permit reconstruction of the initial calibration (e.g., calibration date, method, instrument, analysis date, each analyte name, and analyst or technician’s initials or signature; concentration and response, calibration curve or response factor; or unique equation or coefficient used to reduce instrument responses to concentration); 3. The cannabis testing entity must use the most recent initial calibration analyzed prior to the analytical batch; 4. Standards used for calibration must be traceable to an international or national standard, when commercially available; and 5. The cannabis testing entity must have a written procedure addressing removal and replacement of calibration standards. E. The lowest calibration standard must be at or below the lowest concentration for which quantitative data are to be reported without qualification. F. The highest calibration standard shall be at or above the highest concentration for quantitative data are to be reported without qualification. G. Sample results must be quantitated from the initial calibration and may not be quantitated from any continuing calibration verification. H. Criteria for the acceptance of an initial calibration must be established including any calculations (e.g., relative error, relative standard deviation). 1. R2 ≄ 0.990, and 2. Curve recovery of ±20% (and ±30% for the lowest point) for all points must be maintained. I. The cannabis testing entity must use and document a measure of relative error in the calibration as specified in the method SOP. Initial Calibration Verification A. All initial calibrations must be verified with a standard obtained from a second manufacturer or a separate lot prepared independently by the same manufacturer. B. Initial calibration verification is performed by analyzing a test solution of known analyte concentration(s) after initial calibration and prior to sample analysis. C. In general, the check must be ± 20% (± 30% for the lowest point) of the known value. Some individual methods may require tighter tolerances (±10% of the known value). Continuing Calibration Verification A. The validity of the initial calibration must be verified prior to sample analyses by a continuing calibration verification with each analytical batch. B. A CCV is performed by analyzing a test solution of known analyte concentration(s) prior to sample testing on each testing day and continued periodically during the analytical batch run, no less frequently than once after each set of 20 samples, and at the end of each run. C. The CCV must be a standard that is from the same vendor/lot that is used for the calibration curve. D. In general, the check must be ± 20% (and ± 30% for the lowest point) of the known value. E. Calibration must be verified for each compound, element, or other discrete chemical analyte, except for multi-component analytes where a representative chemical, related substance or mixture can be used. F. Instrument continuing calibration verification must be performed at the beginning and end of each analytical batch, and at the frequency defined in the method. G. Sufficient raw data records must be retained to permit reconstruction of the continuing instrument calibration verification (e.g., method, instrument, analysis date, each analyte name, concentration and response, calibration curve or response factor, or unique equations or coefficients used to convert instrument responses into concentrations). H. Continuing calibration verification records must explicitly connect the continuing calibration verification data to the initial calibration. I. If the continuing instrument calibration verification results obtained are outside the established acceptance criteria, the following steps must be taken: 1. If a cause for the calibration verification failure is identified that impacts only the calibration verification sample (e.g., a missed autosampler injection), then analysis may proceed if a second calibration verification sample is analyzed immediately and the result is within acceptance criteria. Samples analyzed previously must be considered valid if bracketed by a passing calibration verification sample. The cause for the failure of the first calibration verification result must be documented; and 2. If the cause for the calibration verification failure is not identifiable or has impacted other samples, then corrective action must be performed and documented. Prior to analyzing samples, the cannabis testing entity must demonstrate acceptable performance after corrective action with calibration verification or a new initial calibration must be performed. Samples analyzed prior to the calibration verification failure must be reanalyzed. J. Data associated with an unacceptable calibration verification must not be reported with a qualifier. Qualifying the data is not an acceptable approach. Low Level Continuing Calibration Verification A. A LLCCV will be run at the end of each analytical batch. B. The measured value must be within ± 30 % of the prepared value. C. The cannabis testing facility entity shall prepare and analyze at least one of each of the following QC samples for each analytical batch: 1. Negative Control, Method Blank; and 2. Positive Control, Laboratory Control Sample (LCS); 3. Matrix spike sample; 4. Duplicate matrix spike sample; and 5. Duplicate sample. D. The required QC is summarized in Appendix 2, Table 4. Negative Control – Method Blank (MB) A. A method blank must be analyzed at a minimum of one (1) per preparation batch. B. The MB must be processed along with and under the same conditions as the associated samples to include all steps of the preparation and analytical procedure. C. The MB is used to assess the samples in the preparation batch for possible contamination during the preparation and processing steps. D. The measured concentration of each analyte in the MB or LRB must be < LOQ or MRL. E. Procedures must be in place to determine if a MB or LRB is contaminated. While the goal is to have no detectable contaminants, each method blank must be critically evaluated as to the nature of the interference and the effect on the analysis of each sample within the batch. F. The source of contamination must be investigated and measures taken to minimize or eliminate the problem and affected samples reprocessed if the concentration of a targeted analyte in the blank is at or above the LOQ, if the blank contamination otherwise affects the sample results as per the method requirements or the individual project data quality objectives, and a blank is determined to be contaminated. Samples associated with a contaminated blank must be evaluated as to the best corrective action for the samples (e.g., reprocessing or data qualifying codes). In all cases, the corrective action must be documented. G. Any affected samples associated with a contaminated MB or LRB must be reprocessed for analysis. Positive Control – Laboratory Control Sample (LCS) A. The LCS is used to evaluate the performance of the total analytical system, including all preparation and analysis steps. B. The LCS must be carried through the entire sample preparation process and analyzed. C. The LCS must be spiked with all target analytes at a mid-level concentration in the curve. D. The LCS must be analyzed at a minimum of one (1) per preparation batch. E. The LCS is a quality system matrix, known to be free of analytes of interest, spiked with known concentrations of analytes that are within the calibration range. 1. A laboratory control sample (LCS) may be used in place of a continuing calibration verification (CCV) (but not as a replacement for a failing CCV) for methods where the calibration goes through the same process as the LCS. Note that the more stringent acceptance criteria must be met. 2. The matrix spike may be used in place of this control as long as the acceptance criteria are as stringent as for the LCS. 3. The lab may use commercially available or pre-prepared standards (separate from calibrators) for QC. F. All analyte concentrations must be within the calibration range of the methods. G. The individual LCS must be compared to the acceptance criteria stated in the standard operating procedure. The results of the individual batch LCS are calculated in percent recovery or other appropriate statistical technique that allows comparison to established acceptance criteria. The cannabis testing entity must document the calculation. H. When the acceptance criteria for the positive control are exceeded, those sample results must be investigated, and a corrective action implemented. Matrix Spikes and Matrix Spike Duplicates A. Analyze an actual sample with a known amount of standard added (matrix spike. MS). A second portion of the actual sample used to prepare the MS that is spiked and processed in the same manner as the MS (matrix spike duplicate, MSD). 1. For potency testing, a ā€œrepresentative matrixā€ may be used to prepare the MS/MSD. 2. MS/ MSD shall be spiked at a midlevel concentration with the target analytes. B. Calculate the relative percent difference (RPD) between first sample and replicate. The calculations must be documented, and the target value must be close to the first value and have a RPD of less than 20%. C. Matrix-specific QC samples indicate the effect of the sample matrix on the precision and accuracy of the results generated using the selected method. The information from these controls is sample/matrix specific and would not normally be used to determine the validity of the entire batch. D. For methods that include one (1) to twenty (20) targets, spike all components. E. For methods with more than twenty (20) targets, randomly spike at least sixteen (16) components. Sample Duplicate A. Analyze the same sample twice, using two separate preparations. The sample should be chosen at random and run together on the same analytical run. B. Calculate the relative percent difference (RPD) between first sample and replicate. Calculations must be documented, and the target value must be close to the first value and have a RPD of less than twenty percent (20%). Variability may be introduced during sample preparation. To account for this, if more than one staff member is prepping samples, each staff must also prepare and analyze a sample matrix duplicate for each set of prepared samples. 5.11.6 Physical Chemistry. Water Activity: A. Sample Duplicates. Analyze the same sample twice, using two separate preparations. The sample should be chosen at random and run together on the same analytical run. Calculate the relative percent difference (RPD) between first sample and replicate. Calculations must be documented, and the target value must be close to the first value and have a RPD of less than twenty percent (20%). Variability may be introduced during sample preparation. To account for this, if more than one staff member is prepping samples, each staff must also prepare and analyze a sample matrix duplicate for each set of prepared samples. B. Calibration. If the aw instrument is being used in a single location at the same temperature (61°C) and humidity (65% relative humidity), calibrate if it has been more than seven consecutive days since the last calibration. If the aw instrument is physically moved from one location to another, calibrate immediately following the move and prior to analyzing samples. If the aw instrument has been cleaned, then calibrate immediately following the cleaning. Follow any other calibration procedures listed in a consensus method and manufacturer’s instructional manual. C. Monitor temperature and humidity daily or on day of use and keep a record of the check. 5.12 Required Formulas. 5.12.1 The cannabis testing entity shall prepare and analyze at least one of each of the following QC samples for each analytical batch: A. Method Blank; and B. Laboratory control sample (LCS); and C. Matrix spike sample; and D. Duplicate matrix spike sample. 5.12.2 The cannabis testing entity shall analyze, at minimum, a continuing calibration verification (ā€œCCVā€) sample prior to sample testing on each testing day and continued periodically during the analytical batch run no less frequently than once after each set of twenty (20) samples and at the end of each run. The CCV shall be a standard that is not from the same vendor/lot that is used for the calibration curve. 5.12.3 If the result of the chemical analyses is outside the specified minimum acceptance criteria in Appendix A, Table 3, the cannabis testing entity shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria. 5.12.4 A cannabis testing entity shall use the following calculation for determining Relative Percentage Difference (RPD): RPD = (|Num1-Num2|/((Num1+Num2)/2)) x 100 Where: Num1= Original Number Num2= Second Number 5.12.5 A cannabis testing entity shall use the following calculation for determining Relative Standard Deviation (RSD): 5.12.6 For calculating both RPD and RSD if any results are less than the LOQ, the absolute value of the LOQ is used in the equation. 5.12.7 If any analyte is detected above any action level, as described in this Part, the sample shall be re-prepped and reanalyzed in replicate within another analytical batch. 5.12.8 For quantitative analyses, the re-prepped sample and its associated replicate shall meet the acceptance criteria of RPD ≤20%. 5.12.9 For qualitative analyses, the re-prepped sample and its associated replicate results shall concur. 5.12.10 If any quality control sample produces a result outside of the acceptance criteria, the cannabis testing entity cannot report the result and the entire batch cannot be released for retail sale. The cannabis testing entity shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria. 5.12.11 If the cannabis testing entity determines that the result is a false-positive or a false- negative, the Department may ask for the cannabis testing entity to re- sample or re-test. 5.12.12 The cannabis testing entity shall compile and generate one LQC sample report for each analytical batch that includes LQC acceptance criteria, measurements, analysis date, and matrix. 5.13 Limits of Detection (LOD) and Limits of Quantitation (LOQ) for Quantitative Analyses. 5.13.1 The cannabis testing entity shall calculate the LOD for chemical method analyses according to any of the following methods: A. Signal-to-noise ratio of between 3:1 and 2:1; B. Standard deviation of the response and the slope of calibration curve using a minimum of seven (7) spiked blank samples calculated as follows: LOD = (3.3 x standard deviation of the response)/slope of the calibration curve; or C. A method published by the United States Food and Drug Administration (USFDA) or the United States Environmental Protection Agency (USEPA). 5.13.2 The cannabis testing entity shall calculate the LOQ for chemical method analyses according to any of the following methods: A. Signal-to-noise ratio of 10:1, at minimum; B. Standard deviation of the response and the slope using a minimum of seven (7) spiked Blank samples calculated as follows: LOQ = (10 Ɨ standard deviation of the response)/slope of the calibration curve; or C. A method published by the USFDA or the USEPA. 5.14 Cannabis Testing Entity Data Package. 5.14.1 The cannabis testing entity shall compile and generate one data package for each representative sample that the cannabis testing facility analyzes. A. All data generated during the testing of a test sample, except data generated by automated data collection systems, is recorded directly, promptly, and legibly in ink. All data shall be annotated with the date of entry and signed or initialed by the person recording the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or initialed at the time of the change. B. In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in an entry shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or initialed at the time of the change. A corrective action report shall accompany such change and shall be made available to the department, a non-profit producer, and a manufacturer upon their request for up to two years after the analysis is completed. C. For each final result reported, an approved testing entity shall verify that: 1. Any calculations or other data processing steps were performed correctly; 2. The data meet any data quality requirements such as for accuracy, precision, linearity, etc.; 3. Any reference standards used were of the appropriate purity and within their expiration or requalification dates; 4. Any volumetric solutions were properly standardized before use; and, 5. Any test or measuring equipment used has been properly tested, verified, and calibrated, and is within its verification or calibration period. 5.14.2 The cannabis testing entity shall provide requested data packages to the Department immediately upon request. 5.15 Required Proficiency Testing. 5.15.1 A cannabis testing entity shall participate in a proficiency testing program for all methods available from an organization that operates in conformance with the requirements of ISO/IEC 17043 at least once every six (6) months. 5.15.2 The cannabis testing entity shall annually, successfully participate in a proficiency testing program for each test method performed for the below: A. Cannabinoids; B. Heavy metals; C. Microbial impurities ; D. Mycotoxins; E. Residual pesticides; F. Residual solvents and processing chemicals; G. Foreign Material; and H. Terpenoids, if performed. 5.15.3 The cannabis testing entity shall report all analytes available by the proficiency testing program provider and for which the licensee is required to test under the rules in this Part. 5.15.4 The cannabis testing entity shall participate in the proficiency testing program by following the cannabis testing entity’s existing SOPs for testing cannabis and cannabis products. 5.15.5 The cannabis testing entity shall rotate the proficiency testing program among the cannabis testing entity employees who perform the test methods. 5.15.6 Cannabis testing entity employees who participate in a proficiency testing program shall sign the corresponding analytical reports or attestation statements to certify that the proficiency testing program was conducted in the same manner as the cannabis testing entity tests of cannabis and cannabis products. 5.15.7 A supervisory or management cannabis testing entity employee shall review and verify the accuracy of results reported for all proficiency testing program samples analyzed. 5.15.8 The cannabis testing entity shall request the proficiency testing program provider to send results concurrently to the Department, if available, or the cannabis testing entity shall provide the proficiency testing program results to the Department within three (3) business days after the cannabis testing entity receives notification of their test results from the proficiency testing program provider. 5.16 Proficiency Testing Performance. 5.16.1 The cannabis testing entity shall be deemed to have successfully participated in a proficiency testing program for an analyte tested in a specific method if the test results demonstrate a ā€œsatisfactoryā€ or otherwise proficient performance determination by the proficiency testing program provider. 5.16.2 The cannabis testing entity may not report test results for analytes that are deemed by the proficiency testing program provider as ā€œunacceptable,ā€ ā€œquestionable,ā€ ā€œunsatisfactoryā€, or otherwise deficient. Testing with the deficient method shall stop immediately upon receiving deficient proficiency testing results. 5.16.3 The cannabis testing entity may resume reporting test results for analytes that were deemed ā€œunacceptable,ā€ ā€œquestionable,ā€ ā€œunsatisfactoryā€, or otherwise deficient, only if both of the following conditions are met: A. The cannabis testing entity satisfactorily remedies the cause of the failure for each analyte; and B. The cannabis testing entity submits to the Department a written corrective action report demonstrating how the cannabis testing entity has fixed the cause of the failure. 5.16.4 The cannabis testing entity shall immediately perform a follow-up proficiency test on any method associated with a deficient report until the testing entity obtains an acceptable result for all analytes. 5.16.5 The Department shall take immediate disciplinary action against any cannabis testing entity that is unable to successfully participate in a proficiency program for any available method/analyte every six (6) months. 5.17 Cannabis Testing Entity Audits. 5.17.1 The cannabis testing entity shall conduct an internal audit at least once per year or in accordance with the ISO/IEC 17025 accrediting body’s requirement, whichever is more frequent. 5.17.2 The internal audit shall include all the components required by the ISO/IEC 17025 internal-audit standards. 5.17.3 Within three (3) business days of completing the internal audit, the cannabis testing entity shall submit the results of the internal audit to the Department. 5.17.4 A cannabis testing entity shall contract with an independent, third-party auditor certified to conduct on-site audits at least annually or in accordance with ISO/IEC 17025 accrediting body’s requirements standards. 5.17.5 Within three (3) business days of receiving the accrediting body on-site audit findings, the cannabis testing facility shall submit the report to the Department. 5.17.6 The Department reserves the rights to perform additional audits as needed and without advance notice. 5.18 Recalls. 5.18.1 The Department may issue public notice of a medical cannabis recall if, in its judgment, any particular cannabis and/or cannabis product presents a threat to the health and safety of qualifying patients. All medical cannabis establishments are responsible for complying with recall notices. Recalled items shall be immediately pulled from production or inventory and held until such time as the Department determines the item is safe, may be remediated, or shall be destroyed. Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67. Subpart 6 PACKAGING AND LABELING 6.1 General Requirements. 6.1.1 Licensees shall not sell, or otherwise transfer cannabis and/or cannabis products to other medical cannabis establishments licensed by the Department and/or MDOR that are not packaged and labeled in accordance with these regulations. 6.1.2 Medical cannabis establishments receiving a sale or transfer from another medical cannabis establishment shall refuse to accept or shall return to the medical cannabis establishment transferring cannabis and/or cannabis products, any cannabis and/or cannabis products that are not packaged and labeled in accordance with these regulations. The medical cannabis establishment that sold or otherwise transferred the nonconforming cannabis and/or cannabis products shall accept such return. 6.1.3 Medical cannabis establishments shall document any such return, nonacceptance, or disposal, and such documentation shall include at a minimum: 1. The license number, name, contact information, and address of the medical cannabis establishment that sold or otherwise transferred the nonconforming cannabis and/or cannabis products; 2. A complete inventory of the cannabis and/or cannabis products to be returned or disposed, including the batch number; 3. The reason for the nonacceptance, return, or disposal; and, 4. The date of the nonacceptance, return, or disposal. 6.1.4 The following packaging requirements apply to all usable medical cannabis (retail- ready) being transferred to or sold to a medical cannabis dispensary for sale to a qualified patient and/or caregiver. Packaging and labelling, meeting the following requirements, shall be in place when transferred or sold to a medical cannabis dispensary: 1. Labels, packages, and containers shall not be attractive to minors and shall not contain any content that reasonably appears to target children, including toys, cartoon characters, or any color scheme, image, graphic, or feature that might reasonably be expected to make the product label, package, or container entice or appealing to children. 2. Packages should be designed to minimize appeal to children and shall not depict images other than the business name and logo of the medical cannabis establishment. 3. Packaging shall contain a label that reads: ā€œKeep out of reach of childrenā€. 4. All usable medical cannabis and cannabis products shall be packaged in child- resistant containers at the point of sale or other transfer to a patient, a patient's parent, or legal guardian if patient is a minor, or a caregiver. 5. Packages and labels shall not contain product names related to candy or candies or any spellings thereof (e.g., kandy, kandies, etc.) or feature images that look like candy. 6. No cannabis and/or cannabis products shall be intentionally or knowingly packaged or labeled to cause a reasonable patient confusion as to whether the medical cannabis or medical cannabis product is a trademarked product or any commercially available candy, snack, baked good or beverage. 7. Packages and labels shall not make any claims or statements that the medical cannabis or medical cannabis products provide health or physical benefits to the patient. 8. Shall not contain the logo of the Department or any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead any person to believe the product has been endorsed, manufactured, or used by any state, county, or municipality or any agency thereof. 9. Cannabis products that have a potency of over thirty percent (30%) total THC shall be labeled as ā€œextremely potentā€. 10. Edible cannabis products shall be labeled in a manner which indicates the number of servings of THC in the product and include a statement that the product’s potency was tested with an allowable variance of plus or minus 10%. Potency of all products shall test +/- 10% of label claim or be repackaged to meet actual concentration. The single serving size shall also be included on the label. All edible cannabis product shall be labeled. 11. Usable medical cannabis shall include the following on the label: a. Name of the cannabis and/or cannabis product; b. Batch number of the cannabis and/or cannabis product; c. Unique identifier number created by the seed to sale system; d. Net quantity or weight of contents; e. The length of time it typically takes for the product to take affect; f. Disclosure of ingredients and possible allergens; g. A nutritional fact panel (applicable to cannabis products meant to be ingested); h. The total amount of THC and CBD in the product as verified by the cannabis testing facility; i. Terpenoid profile in the product as verified by the cannabis testing facility (if applicable); j. A notice of the potential harm caused by consuming medical cannabis; and, k. For edible cannabis products, when practicable, the Mississippi standard symbol indicating the product contains cannabis. This symbol is required on packaging as of July 1, 2023. The required symbol will be available for download from the Department. 6.1.5 All usable medical cannabis and/or cannabis products shall be in compliant packaging upon entering the medical cannabis dispensary space. 6.1.6 All labeling shall be in plain font that can be easily read. 6.1.7 All labeling on topical products shall also state ā€œFor Topical Application – Do Not Eat or Smokeā€. 6.1.8 Labels and packaging for food containing cannabis shall comply with all applicable requirements in existing Mississippi law, rules and regulations. 6.1.9 In addition to the labeling requirements in this Part, all usable (retail-ready) cannabis and/or cannabis products shall be packaged to meet the following: 1. Packaging shall be opaque and light resistant. The Department does not specify package coloring. 2. Packing shall fully enclose the product so that it cannot be seen from outside the packaging. 3. Packaging shall protect the product from contamination; 4. Not impart any toxic or deleterious substance to the medical cannabis product; 5. Shall be in child-resistant packages or containers; and, 6. Shall be in a resealable package or container that meets the effectiveness specifications outlined in 16 CFR 1700.15, to the extent that such laws, rules, regulations do not conflict with the Mississippi Medical Cannabis Act, if the product contains more than one serving. 6.1.10 All cannabis and/or cannabis products sold or transferred between cannabis cultivation facilities and/or cannabis processing facilities shall be labeled (in addition to the required seed-to-sale tagging), and the label shall contain, at a minimum, the following information: 1. Name and license number of the cultivator/grower or processor/manufacturer who is selling or otherwise transferring the medical cannabis or medical cannabis product; 2. The batch number of the medical cannabis or medical cannabis product; 3. Date of harvest or production; and, 4. Unique identifier number generated by the seed-to-sale system. Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67. Subpart 7 TRANSPORTATION 7.1 General Requirements. 7.1.1 Cannabis transportation entities shall comply with any and all motor vehicle laws in the State of Mississippi. 7.1.2 All employees shall possess a valid, unrestricted driver’s license issued by the State of Mississippi and a valid work permit issued by the Department. The cannabis transportation entity shall also issue each employee an identification badge, with picture. All documents referenced in this Rule shall be in the employee’s possession when in a vehicle transporting cannabis and/or cannabis products. 7.1.3 A cannabis transportation entity shall be responsible for any and all cannabis and/or cannabis products within its custody, control, or possession. 7.1.4 A cannabis transportation entity may transport cannabis and/or cannabis products to medical cannabis establishments during the hours of 5:00 a.m. until 9:00 p.m. 7.1.5 Prior to the transport of cannabis and/or cannabis products, the cannabis transportation entity shall ensure a trip plan has been created for each transportation event. At a minimum, a trip plan shall include the following: 1. Names of employees transporting the cannabis and/or cannabis products; 2. State issued work permits of the employees transporting the cannabis and/or cannabis products; 3. Date and start time of the transport; 4. Physical location of the originating medical cannabis establishment; 5. Physical location of the receiving medical cannabis establishment; 6. A description of the cannabis and cannabis products to be transported to include: quantities by weight or unit of each type of cannabis and/or cannabis products contained in the transport, along with the unique identifying numbers issued by the seed to sale system for each item; 7. Any anticipated stops during the trip, including the locations of the stop and arrival and departure time from the location; 8. The anticipated route of transportation; 9. Any and all instances in which cannabis and/or cannabis products are stored at cannabis transportation entity’s facilities; and, 10. Estimated date and time of arrival at the receiving medical cannabis establishment. 11. The make, model, color and license plate number of the vehicles transporting cannabis and/or cannabis products. 7.1.6 A copy of the trip plan shall be provided to the originating medical cannabis establishment and maintained by the cannabis transportation entity. A copy of the applicable trip plan shall be kept in the vehicle during transport. 7.1.7 A cannabis transportation entity may make reasonable deviations from the anticipated routes identified on the trip plan when needed (for example, unanticipated mandatory detours for construction, traffic accidents, etc.). All deviations shall be reflected in the transportation entity’s vehicle GPS system at all times. 7.1.8 Should a cannabis transportation entity possess cannabis and/or cannabis products outside of the approved transportation hours, the licensee shall immediately go to its facility and store the cannabis and/or cannabis products in accordance with the rules in this Part. 7.1.9 To maintain the independence required, cannabis transportation entities are prohibited from the following activities related to the medical cannabis program: 1. Growing/cultivating cannabis; 2. Manufacturing/processing cannabis and/or cannabis products; 3. Retail sales of cannabis and/or cannabis products; 4. The resale of cannabis and/or cannabis products to other entities and medical cannabis establishments; 5. Transportation, storage, and/or delivery of cannabis and/or cannabis products to entities who are not licensed by the Department as medical cannabis establishments or the MDOR as cannabis dispensaries; and, 6. Provision of cannabis and/or cannabis products directly to qualifying patients and/or caregivers as defined in this Part. 7.1.10 A cannabis transportation entity shall have inventory tracking processes and procedures in place that include, but are not limited to, the following: 1. Prior to the transport of cannabis and/or cannabis products, the originating medical cannabis establishment shall provide the transporter with a copy of the inventory/transportation manifest generated from the seed-to-sale system. At a minimum, the manifest shall include the following: a. License number of the originating medical cannabis establishment; b. Name and contact information of the originating medical cannabis establishment; c. License number of the receiving medical cannabis establishment; d. Name and contact information of the receiving medical cannabis establishment; e. Physical address of the receiving medical cannabis establishment where cannabis and/or cannabis products are being delivered; f. Quantities by weight or unit of each type of cannabis and/or cannabis products contained in the transport, along with the unique identifying numbers issued by the seed-to-sale system for each item; g. The date of transport to include the time of departure and approximate arrival time; h. Names and work permit numbers issued by the Department of the individuals accompanying the transport; i. The make, model, color, and license plate number of the vehicles providing transport of cannabis and/or cannabis products. 7.1.11 An inventory/transportation manifest shall be included with each transport. 7.1.12 An inventory/transportation manifest shall not be altered after departing the originating medical cannabis establishment. Such manifest made be made available to law enforcement, if requested. 7.1.13 There shall not be any passenger or operator in a vehicle transporting cannabis and/or cannabis products that is not employed by the cannabis transportation entity while cannabis and/or cannabis products are present. 7.1.14 Transportation of Cannabis or Cannabis Products to Retail Dispensary Locations. A. Cannabis and/or cannabis products that have undergone and passed regulatory compliance testing and have an accompanying COA may be transferred to one or more licensed dispensaries via a licensed cannabis transportation entity. B. Cannabis that has not been transported to a licensed dispensary for retail sale within twelve (12) months of the date on the COA shall be destroyed or retested by the licensee in possession thereof. Retesting pursuant to this subsection shall only be conducted if the cannabis has not been modified in any way. 7.2 Vehicle Requirements. 7.2.1 Prior to use, a licensed cannabis transportation entity shall submit to the Department the license plate numbers, proof of insurance, and vehicle identification numbers for each vehicle being used to transport cannabis or cannabis-infused products. 7.2.2 Vehicles used to transport cannabis and/or cannabis products shall be insured at or above the legal requirements in Mississippi. 7.2.3 Vehicles used to transport cannabis and/or cannabis products shall be equipped with the following: 1. An alarm system; 2. A global positioning system (GPS) to monitor location, routes, etc. at all times with the ability to grant the Department and/or state and local law enforcement access to the system; and, 3. Locked storage container as defined in Rule 1.2.73. 7.2.4 With the exception of test samples, all vehicles used to transport cannabis and/or cannabis products shall meet one of the following requirements for video surveillance or staffing required during transport of cannabis and/or cannabis products: 1. Staffed with a minimum of two (2) employees when a vehicle contains cannabis and/or cannabis products. At least one (1) employee shall remain with the vehicle any time it contains cannabis and/or cannabis products; or 2. Utilize video surveillance of the vehicle (meeting video surveillance requirements in Rule 7.3.5) to include: a. Installation of video cameras in the interior of vehicles transporting cannabis and/or cannabis products; and, b. Video surveillance of the interior of the vehicle, particularly the locked storage areas where cannabis and/or cannabis products are located. 7.2.5 All vehicles used for the purpose of transporting cannabis and/or cannabis products shall be maintained in a sanitary condition. 7.2.6 A vehicle transporting cannabis and/or cannabis products shall not bear any markings to indicate the vehicle contains cannabis or bear the name or logo of the medical cannabis establishment. 7.3 Storage Requirements – During and Outside of Transport. 7.3.1 A transporter shall not transport cannabis and/or cannabis product(s) unless it is first packed in a cannabis container by the originating medical cannabis establishment. 7.3.2 A cannabis container for transport shall be: 1. Sealable and sealed during transport; 2. Locked during transport; 3. Clearly labeled as medical cannabis and/or medical cannabis product; 4. Maintained in a locked and secure storage compartment that is part of the vehicle or a locked storage container with a separate key or combination lock. 7.3.3 A transporter shall not open a cannabis container. Once a cannabis container is packed and sealed for delivery, only the following may open a cannabis container: 1. The originating medical cannabis establishment; 2. The medical cannabis establishment intended for delivery; 3. Local, State, or federal law enforcement; 4. An employee of the Department or the MDOR. 7.3.4 Cannabis and/or cannabis-products shall be transported so it is not visible or recognizable from outside the vehicle. 7.3.5 If a cannabis transportation entity is required to store cannabis and/or cannabis products, the storage location shall, at a minimum, meet the following requirements: 1. Approved by the Department during the application process as part of the cannabis transportation entity’s license; 2. Be secure, enclosed with permanent walls, and controls for temperature and relative humidity to ensure storage in a manner that prevents the cannabis and cannabis products from becoming adulterated.; 3. Be locked at all times; 4. Be accessible only to specifically identified employees of the cannabis transportation entity; 5. Have an alarm system that meets the following: a. Upon attempted unauthorized entry, the alarm system shall transmit a signal directly to a central protection company or a law enforcement agency that has a legal authority to respond. A designated employee of the cannabis transportation entity shall also be notified. b. Provide continuous, uninterrupted coverage (24 hours/7 days) for all points of ingress and egress to the facility, including without limitation doorways, windows, loading areas; c. Provide continuous, uninterrupted coverage (24 hours/7 days) of any room with an exterior wall, any room containing a safe, and any room used to store cannabis and/or cannabis products; d. Be equipped with failure notification systems to notify the transporter and law enforcement of any failure in the alarm system; and, e. Have the ability to remain operational during a power outage. 6. Have continuous, uninterrupted video surveillance that meets the following: A. Provide continuous, uninterrupted coverage (24 hours/7 days) for all points of ingress and egress to the facility, including without limitation doorways, windows, loading areas, and parking areas; B. Provide continuous, uninterrupted coverage (24 hours/7 days) of any room with an exterior wall, any room containing a safe, and any room used to store cannabis and/or cannabis products; C. Digital archiving capabilities for a minimum of (120) days; D. On-site and off-site monitoring capabilities; E. Have the date and time embedded on all surveillance recordings without significantly obscuring the picture; and, F. Use cameras that are capable of recording in both high and low lighting conditions. 7.3.6 Upon request, a medical cannabis establishment shall make all information related to security alarm systems and video surveillance, monitoring, and recordings available to the Department within the timeframe requested. Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67. Subpart 8 WASTE DISPOSAL 8.1.1 Cannabis disposal entities shall also comply with all applicable rules and regulations in this Part to include, but not limited to, licensure and registration as a cannabis transportation entity if the cannabis disposal entity transports cannabis and/or cannabis products. 8.1.2 All employees shall possess a valid, unrestricted driver’s license issued by the State of Mississippi and a valid work permit issued by the Department. The cannabis disposal entity shall also issue each employee an identification badge, with picture. All documents referenced in this Rule shall be in the employee’s possession when in a vehicle transporting cannabis and/or cannabis products. 8.1.3 A cannabis disposal entity shall be responsible for any and all cannabis and/or cannabis products within its custody, control, or possession. 8.1.4 Unless specifically licensed by the Department to do so, cannabis disposal entities are prohibited from the following activities related to the medical cannabis program: 1. Growing/cultivating cannabis; 2. Manufacturing/processing cannabis and/or cannabis products; 3. Retail sales of cannabis and/or cannabis products; 4. The resale of cannabis and/or cannabis products to other entities and medical cannabis establishments; 5. Transportation, storage, and delivery of cannabis and/or cannabis products (outside of the purposes of disposal and/or destruction of cannabis waste); and, 6. Provision of cannabis and/or cannabis products directly to qualifying patients and/or caregivers as defined in this Part. 8.1.5 If a cannabis disposal entity is required to store cannabis and/or cannabis products, the storage location shall, at a minimum, meet the following requirements: 1. Cannabis and/or cannabis products shall be stored at location licensed by the Department as part of the cannabis disposal entity’s license; 2. Be secure and enclosed with permanent walls; 3. Be locked at all times; 4. Be accessible only to specifically identified employees of the cannabis transportation entity; 5. Have an alarm system that meets the following: A. Upon attempted unauthorized entry, the alarm system shall transmit a signal directly to a central protection company or a law enforcement agency that has a legal authority to respond. A designated employee of the cannabis transportation entity shall also be notified; B. Provide continuous, uninterrupted coverage (24 hours/7 days) for all points of ingress and egress to the facility, including without limitation doorways, windows, loading areas; C. Provide continuous, uninterrupted coverage (24 hours/7 days) of any room with an exterior wall, any room containing a safe, and any room used to store cannabis and/or cannabis products; D. Be equipped with failure notification systems to notify the transporter and law enforcement of any failure in the alarm system; and, E. Have the ability to remain operational during a power outage. 6. Have continuous, uninterrupted video surveillance that meets the following: A. Provide continuous, uninterrupted coverage (24 hours/7 days) for all points of ingress and egress to the facility, including without limitation doorways, windows, loading areas, and parking areas; B. Provide continuous, uninterrupted coverage (24 hours/7 days) of any room with an exterior wall, any room containing a safe, and any room used to store cannabis and/or cannabis products; C. Digital archiving capabilities for a minimum of (120) days; D. On-site and off-site monitoring capabilities; E. Have the date and time embedded on all surveillance recordings without significantly obscuring the picture; and, F. Use cameras that are capable of recording in both high and low lighting conditions. 8.1.6 All cannabis waste designated for disposal shall be properly weighed and recorded in the state’s seed-to-sale system at the following points at minimum: 1. On-site at the medical cannabis establishment for which the cannabis disposal entity is providing services; and, 2. At the final destination where disposal/destruction occurs. 8.1.7 Cannabis waste shall be disposed of either via a process which renders the waste unusable and unrecognizable through physical destruction or a recycling process that the waste disposal facility is authorized by Mississippi law to carry out. 8.1.8 The disposal/destruction of cannabis waste shall be done under video surveillance by video surveillance and made available to the Department upon request. 8.1.9 Medical cannabis and/or cannabis products shall be rendered unusable by grinding and incorporating the cannabis waste with other ground materials, so the resulting mixture is at least fifty percent 50% non-cannabis waste by volume. This includes compostable mixed waste and non-compostable mixed waste meeting the requirements below. 8.1.10 Grinding and incorporating the cannabis waste into compostable mixed waste until it is unusable and unrecognizable: Cannabis waste to be disposed of as compost or in another organic waste method may be mixed with the following types of waste materials: 1. Food waste; 2. Yard waste; 3. Vegetable based grease oils; 4. Agricultural Materials; 5. Biodegradable products and paper; 6. Clean wood; 7. Fruits and vegetables; or 8. Plant matter. 9. Bokashi or other compost activators; or, 10. Other materials or methods approved by the Department that will render the cannabis waste unusable and unrecognizable. 8.1.11 Grinding and incorporating the cannabis waste into non-compostable mixed waste until it is unusable and unrecognizable: Cannabis waste to be disposed of in a landfill or another disposal method, such as incineration, may be mixed with the following types of waste materials: 1. Paper waste; 2. Cardboard waste; 3. Plastic waste; 4. Soil; 5. Nonrecyclable plastic; 6. Broken glass; 7. Sawdust; or 8. Other materials or methods approved by the Department that will render the cannabis waste unusable and unrecognizable. 8.1.12 Licensure and/or permitting may also be required through the Mississippi Department of Environmental Quality for cannabis disposal entities as well as local permitting, dependent upon the location of the cannabis disposal entity. Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67. Subpart 9 ADVERTISING AND MARKETING 9.1 Prohibition Against Advertising and Marketing. 9.1.1 Medical cannabis establishments licensed by the Department pursuant to this Part, and/or entities acting on their behalf, are prohibited from advertising and marketing in any media, including but not limited to: A. Broadcast or electronic media: 1. Radio 2. Television 3. Unsolicited internet pop-up advertising 4. Social media B. Print media: 1. Newspaper C. Other forms: 1. Mass text/messaging communications. 2. Mass email communications. 3. Medical cannabis or medical cannabis products shall not be displayed in windows or public view. 4. Advertisement in any manner that can be viewable or otherwise perceived as a public space, including, but not limited to, adopt a highway signs, and electronic interstate signs. 5. Solicited/paid patient and/or caregiver reviews/testimonies/endorsements. 6. Solicited/paid practitioner reviews/testimonies/endorsements. 9.1.2 Licensees shall not engage in advertising that contains any statement or illustration that: A. Depicts the actual consumption of cannabis or cannabis products; B. Promotes the overconsumption of cannabis or cannabis products; C. Makes any health, medicinal, or therapeutic claims about cannabis or cannabis products; D. Makes safety claims of any type; E. Includes the image of a cannabis leaf or bud; or F. Includes any image designed or likely to appeal to minors, including cartoons, toys, animals, or children or any other likeness, images, characters, or phrases that are designed in any manner to be appealing to children and/or youth. 9.2 Branding Requirements. 9.2.1 Medical cannabis establishments licensed by the Department pursuant to this Part are permitted to participate in branding activities as described in Rules 9.2.2 and 9.2.3 in order to publicize their businesses. Additionally, the business name and contact information of all licensed medical cannabis establishments will be made available by the Department through a public website. 9.2.2 Permissible branding activities include: 1. Establishment of a website and/or social media presence that provides general information on the licensed entity’s contact information, retail dispensing locations, and a list of products available.; 2. Listings in business directories (inclusive of phone books, cannabis-related or medical publications);. 3. Display of cannabis in company logos and other branding activities; and, 4. Sponsorships of health or not-for-profit charity or advocacy events. 9.2.3 Branding shall not target minors, pregnant women, breastfeeding women, or promote non-medical use of cannabis. 9.2.4 Branding, in the form of business signage, for all licensed medical cannabis establishments is subject to local zoning and permitting requirements. 9.3 Use of Inducements. 9.3.1 Licensees may utilize inducements to assist qualified patients. Inducements shall not persuade or influence the use of medical cannabis outside of practitioner recommendations and/or limitations or the amounts allowed by the Mississippi Medical Cannabis Act. Examples of inducements include, but are not limited to: 1. The use of discount cards; 2. The use of coupons; 3. The use of ā€œpunch cardsā€ to offer discounts/free products; 4. Promotion of sales/discounts on medical cannabis of any type; 5. The use of ā€œbuy one, get oneā€ discount approaches; and, 6. The use of any type of ā€œdaily dealā€, ā€œweekly dealā€, ā€œmonthly dealā€, etc. 9.3.2 Any medical cannabis and medical cannabis products that are part of an inducement program as defined in Rule 9.3.1, remain subject to seed-to-sale tracking requirements, any practitioner limitation included on the qualified patient’s written certification, and MMCEU allotment limitations set forth in the Mississippi Medical Cannabis Act. 9.4 Education Regarding the Risks and Benefits of Medical Cannabis. 9.4.1 Education on the risks and benefits of the use of medical cannabis between a registered practitioner and/or medical cannabis establishment and a qualified patient, caregiver, parent, or legal guardian is permissible. This education is not considered advertising or marketing. 9.4.2 Education on the risks and benefits of the use of medical cannabis between a registered practitioner and/or medical cannabis establishment and a qualified patient, caregiver, parent, or legal guardian can also include written or video educational materials that are inclusive of the medical cannabis establishment’s brand. 9.4.3 Education provided to a qualified patient, caregiver, parent, or legal guardian by a registered practitioner and/or medical cannabis establishment that includes instruction/direction on the safe use of medical cannabis and/or medical cannabis products is permissible. 9.4.4 Except as otherwise provided in this Part the use of pictures and/or images of cannabis and/or cannabis products shall be limited to patient education materials. 9.4.5 A registered practitioner or medical cannabis establishment may provide educational materials about cannabis to qualifying patients and/or their designated caregivers, parents and/or legal guardians. Educational materials shall adhere to the following: A. Information about the potential risks and side effects of medical cannabis use, including the risk of poisoning and the number for the closest poison control center shall be included; B. Information to assist in the selection of cannabis, describing the potential differing effects of various strains of cannabis, as well as various forms and routes of administration, purported effectiveness of various methods, and the differences in the anticipated time frames for the forms to take affect may be included; C. Materials offered to registered qualifying patients and their personal caregivers to enable them to track the strains used and their associated effects may be included; D. Information on tolerance, dependence, and withdrawal may be included; E. Information regarding substance abuse signs and symptoms, as well as referral information for substance abuse treatment programs; and, F. Other warnings, instructions, and/or directions on the safe use of medical cannabis and/or medical cannabis products which the registered practitioner and/or medical cannabis establishment deems appropriate. Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67. Subpart 10 VARIANCE REQUESTS 10.1.1 Through a variance, the Department may waive provisions of this Part on its own initiative or by request from licensed medical cannabis establishments. The Department shall not consider Variance Requests related to provisions that are purely statutory. 10.1.2 Requests for variance from the rules of any provision of this Part shall be made in writing and will be granted or denied by the State Health Officer. Variance Requests shall include: 1. A list of each rule for which a variance is requested, with citation to the specific rule(s); 2. An explanation of why the rule cannot be met at the time of the request or why meeting the rule would impose an undue burden on the licensed medical cannabis establishment; and, 3. The requested relief. Denial of variance requests shall be issued by the Department in writing and shall include the specific reasons for the denial. 10.1.3 The Variance Request shall be submitted by the primary contact of the licensed medical cannabis establishment in a format approved by the Department. 10.1.4 Variance Requests are not guaranteed for approval and will not be approved to circumvent any relevant rule, regulation or standards promulgated under the Act or any portion thereof. The medical cannabis establishment making the Variance Request should continue to meet Department-published rules in this Part while the Request is under consideration and pending. Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67. Subpart 11 ENFORCEMENT AND PENALTIES 11.1 Suspension or Revocation of License, Fines or Other Penalties. 11.1.1 The Department may take the following actions against licensees, alone or in combination, in any case in which it finds that a licensee has failed to comply with the requirements established by the Mississippi Medical Cannabis Act and/or the rules, regulations or standards promulgated in furtherance of such act: A. Impose monetary penalties; B. Issue an Administrative Hold; C. Suspend a license; D. Revoke a license; E. Accept the voluntary surrender of a license; F. Confiscate or seize cannabis plants, cannabis and/or cannabis products; G. Order destruction of cannabis plants, cannabis and/or cannabis products; H. Recall cannabis and/or cannabis products; or I. Accept the voluntary surrender of cannabis plants, cannabis and/ cannabis products. The schedule of disciplinary actions included as APPENDIX B to this Part shall be used when administratively disciplining medical cannabis establishments for violating statutory and/or regulatory requirements. The Department reserves the right to increase penalties based on aggravating circumstances and/or the medical cannabis establishment’s history of violations and corrective actions. 11.1.2 Suspension. In addition to the schedule of disciplinary actions included as APPENDIX B to this Part, the Department may suspend the license of a medical cannabis establishment if necessary to protect public health, safety, or welfare. A suspension shall not exceed a period longer than six (6) months. A medical cannabis establishment may continue to possess and cultivate cannabis as otherwise authorized to do so under its license during a suspension, but it may not dispense, transfer or sell cannabis. 11.1.3 The Department may seize, destroy, confiscate or place an administrative hold on any cannabis plants, cannabis and/or cannabis products under, but not limited to, the following circumstances: A. Failure to log and/or tag in the seed-to-sale system; B. Alteration of cannabis and/or cannabis products in a manner that fails to comply with this Part; C. Failure to package and label in accordance with this Part in general and Section 11 specifically; D. Such items are cultivated, harvested, manufactured or transferred in a manner, or otherwise in a form, not compliant with the rules/regulations in this Part or the Mississippi Medical Cannabis Act Use; or E. Improper use, handling, storage, transport, transfer or other possession of such items. 11.1.4 Administrative Holds. The Department may order an administrative hold of cannabis plants, cannabis and/or cannabis products to prevent destruction of evidence, diversion or other threats to public safety, while permitting a licensee to retain its inventory pending further investigation, pursuant to the following procedure: A. If during an investigation or inspection of a licensee, an employee or agent of the Department develops reasonable grounds to believe certain cannabis plants, cannabis or cannabis products constitute evidence of acts in violation of the rules/regulations in this Part, the Mississippi Medical Cannabis Act or constitute a threat to the public health or safety, the Department may issue a notice of administrative hold of any such cannabis plants, cannabis or cannabis products. The notice of administrative hold shall provide a documented description of the cannabis plants, cannabis and/or cannabis products subject to the administrative hold and a concise statement regarding the reasons for issuing the administrative hold. B. The Department will identify the cannabis plants, cannabis and/or cannabis products subject to the administrative hold in the seed-to-sale system. The licensee shall continue to comply with all inventory tracking requirements of the seed-to-sale system. C. The licensee shall completely and physically segregate the cannabis plants, cannabis and/or cannabis products subject to the administrative hold in a limited access area of the licensed premises under investigation, where it shall be safeguarded by the licensee. D. While the administrative hold is in effect, the licensee is prohibited from selling, giving away, transferring, transporting or destroying the cannabis plants, cannabis and/or cannabis products subject to the administrative hold, except as otherwise authorized by this Part. E. While the administrative hold is in effect, the licensee must safeguard the cannabis plants, cannabis and/or cannabis products subject to the administrative hold, must maintain the licensed premises in reasonable condition according to health, safety and sanitary standards, and must fully comply with all security requirements, including but not limited to all surveillance, lock and alarm requirements in this Part. F. Nothing herein shall prevent a licensee from voluntarily surrendering cannabis plants, cannabis and/or cannabis products that is subject to an administrative hold, except that the licensee shall follow the procedure authorized by the Department to complete the voluntary surrender. G. Nothing herein shall prevent a licensee from the continued possession, cultivation or harvesting of the cannabis plants, cannabis and/or cannabis products subject to the administrative hold. H. At any time after the initiation of the administrative hold, the Department may lift the administrative hold or seek other appropriate relief. 11.1.5 Notice. At the time of denial of an application for licensure or the imposition of any monetary penalty and prior to imposition of non-monetary sanctions, suspension or revocation of a license, written notice of the contemplated action shall be given to the applicant or licensee specifying the reason(s) for the proposed action and shall notify the licensee of the right to a hearing on the matter. The Department shall provide its initial notice of denial, suspension, revocation, fine or other sanction by personal delivery, mailing by certified mail, signature required, or by electronic mail to the applicant or licensee, at the address on record with the Department. 11.1.6 Request for an Administrative Appeal/Hearing. The Mississippi State Department of Health will provide to a licensee/aggrieved party an opportunity for a prompt and fair appeal process when the licensee/aggrieved party is dissatisfied with an administrative decision imposing fines and/or other penalties/sanctions, denial, suspension, or revocation of a license and wishes to appeal the administrative decision. A. Upon written request by the licensee/aggrieved party and within twenty (20) days of receipt of the initial notice of administrative action, the licensee/aggrieved party may file a request for an appeal which is handled through the means of an administrative hearing with the Department. Once a licensee/aggrieved party requests an appeal, the State Health Officer shall be notified by the Department and shall appoint a qualified Hearing Officer within thirty (30) days to set a date, time and place for the administrative hearing convenient for all parties. B. If the licensee/aggrieved party fails to appeal the initial notice within the prescribed time, the decision becomes final and cannot be further appealed. C. A court reporter shall attend and transcribe the proceeding. D. Hearings before a Hearing Officer are considered confidential and are not open to the public. E. An informal review may be granted for any situation, but is not required before seeking an administrative appeal, and if requested, does not toll the time limit to request an appeal/administrative hearing. F. The parties may continue to attempt to resolve issues informally once the formal appeals process has begun. G. The licensee/aggrieved party shall be entitled to legal representation at the hearing at his/her own expense but may also choose to represent himself/herself. The burden shall be on the licensee/aggrieved party at the hearing to prove that the Department’s decision was: (a) arbitrary or capricious; (b) unsupported by evidence; (c) beyond the power of the Department to make; or (d) violated a statutory or constitutional right of the aggrieved party. H. A continuance for an administrative hearing may only be requested by a showing of good cause and may be granted at the discretion of the Hearing Officer. A request for a continuance shall be made within ten (10) days of the date for which it is needed unless it is due to an emergency. 1. Within thirty (30) calendar days of the hearing, or such period as determined during the hearing, written findings of fact together with a recommendation from the Hearing Officer shall be forwarded to the State Health Officer for review. The State Health Officer may adopt, modify, or reject the Hearing Officer’s recommendation or decide what, if any, action is to be taken on the matter. The decision by the State Health Officer will be made within fourteen (14) calendar days of receipt of the recommendation from the Hearing Officer and will be considered the Final Decision or Final Order by the Department. 2. Written notice of the decision shall be provided to the licensee/aggrieved party at the address on record with the Department. Licensee/aggrieved party has a duty to update his/her address as necessary to receive correspondence in a timely manner. 3. Appeal of the Department’s Final Order shall be accomplished as provided by the appropriate statute. 4. If the licensee/aggrieved party fails to appeal the Final Order within the prescribed time, the decision becomes final and cannot be further appealed. 5. For the Rules and Procedures for State Level Administrative Hearings refer to APPENDIX C of this Part. 11.2 Appeal of Final Decisions or Orders. 11.2.1 Any person or entity who disagrees with or is aggrieved by the Final Decision or Final Order of the Department concerning the imposition of fine(s) and/or other sanction(s), including but not limited to, denial of an application for licensure, suspension, or revocation of a license may appeal same in the circuit court of the county in which he/she resides. If the aggrieved party is a nonresident of this state, he/she may appeal to the Circuit Court of the First Judicial District of Hinds County, Mississippi. The appeal shall be filed no later than twenty (20) calendar days after the issuance of the Final Decision or Order by the Department. 11.2.2 The review by the circuit court shall be based on the record made before the Department. Before filing an appeal petition in circuit court, the appellant shall obtain from the Department an estimate of the cost to prepare the entire record of the Department and shall pay to the Department the amount of the estimate. The circuit court shall dismiss with prejudice any petition filed where it is shown that the petitioner failed to pay prior to filing the petition the estimated cost for preparation of the record. On appeal to the circuit court, appellant shall have the burden of proving that the decision of the Department was: (a) arbitrary or capricious; (b) unsupported by substantial evidence; (c) beyond the power of the administrative agency to make; or (d) violated some statutory or constitutional right of the licensee/aggrieved party. 11.2.3 Any person or entity aggrieved by the decision of the circuit court may appeal to the Mississippi Supreme Court. 11.2.4 If a medical cannabis establishment is allowed to continue to operate during the appeal process, it will remain under the regulation of the Department and will be subject to all current licensure regulations to include, but not limited to, inspection of the facility, review of facility and/or records, submission of all required or requested documents, and payment of all applicable fees and/or monetary penalties. However, the medical cannabis establishment may not dispense, transfer or sell cannabis during this period. 11.2.5 A cannabis testing entity may continue to possess cannabis under its license during a suspension but shall not receive, transfer or test cannabis during the suspension period. Source: Miss. Code Ann. §§ 41-137-1 – 41-137-67. APPENDIX A Table 1 Key to Table 1: • CAS Number = Chemical Abstract Services Registry number • CFU = Colony-forming unit, a method to estimate the number of viable bacteria or fungal cells in a sample. A. Microbial Contaminants Analyte Maximum Allowable Contaminants Required Action Total coliform 100 CFU/g Use to make a concentrate or extract if the processing method effectively sterilizes the batch and retested or destroy Shiga toxin- producing Escherichia coli Detectable in 1 gram Destroy Salmonella spp. Detectable in 1 gram Destroy Aspergillus flavus, Aspergillus fumigatus, Aspergillus niger, and Aspergillus terreus Inhalable: Detectable in 1 gram Use to make a concentrate or extract if the processing method effectively sterilizes the batch and retest or destroy Mycotoxins: Aflatoxin B1, B2, G1, and G2 Ochratoxin A Cannabis product, except a cannabis product intended for topical application, prepared from an extract or concentrate of medical cannabis Destroy Total Mold and Yeast 10,000 CFU/g Use to make a concentrate or extract if the processing method effectively sterilizes the batch and retest or destroy B. Heavy Metals Analyte Maximum Allowable Concentration (ppm) Required Action Inhaled Flower Inhaled Concentrates Other Arsenic 0.4 0.2 1.5 Remediate and retest, or Destroy *Copper is required for vaping products only Cadmium 0.4 0.2 0.5 Lead 1.0 0.5 0.5 Mercury 0.2 0.1 3.0 Total Chromium 1.2 0.6 2.0 Nickel 1.0 0.5 N/A Copper N/A 3.0* N/A C. Residual Solvents Analyte CAS Number Maximum Allowable Concentration Required Action Acetone 67-64-1 1,000 ppm Remediate and retest, or Destroy Acetonitrile 75-05-8 410 ppm Benzene 71-43-2 2 ppm Butanes (measured as the cumulative residue of n-butane and isobutane) respectively 106-97-8 and 75- 28-5, 5,000 ppm Chloroform 67-66-3 60 ppm Dichloromethane 75-09-2 600 ppm Ethanol 64-17-5 5,000 ppm Ethyl Acetate 141-78-6 5,000 ppm Ethyl Ether 60-29-7 5,000 ppm Heptane 142-82-5 5,000 ppm Hexanes (measured as the cumulative residue of n-hexane, 2- methylpentane, 3- methylpentane, 2,2- dimethylbutane, and 2,3- dimethylbutane) 110-54-3, 107- 83-5, and 79-29-8 290 ppm Isopropyl Acetate 108-21-4 5,000 ppm Methanol 67-56-1 3,000 ppm Pentanes (measured as the cumulative residue of n-pentane, iso- pentane, and neo- pentane) 109-66-0, 78-78- 4, and 463-82-1 5,000 ppm 2-Propanol (IPA) 67-63-0 5,000 ppm Propane 74-98-6 5,000 ppm Toluene 108-88-3 890 ppm Xylenes (measured as the cumulative residue of 1,2- dimethylbenzene, 1,3- dimethylbenzene, and 1,4- dimethylbenzene, And the non-xylene, ethyl benzene) 1330-20-7 (95- 47-6,108- 38-3, and 106- 42- 3, and 100-41-4) 2,170 ppm Dimethylbenzene, and 1,4- dimethylbenzene, and the non- xylene, ethyl benzene) D. Pesticides, Fungicides, Growth Regulators Analyte CAS Number Maximum Allowable Concentration Required Action Abamectin 71751-41-2 0.5 ppm Destroy Acephate 30560-19-1 0.4 ppm Acequinocyl 57960-19-7 2.0 ppm Acetamiprid 135410-20-7 0.2 ppm Aldicarb 116-06-3 0.4 ppm Azoxystrobin 131860-33-8 0.2 ppm Bifenazate 149877-41-8 0.2 ppm Bifenthrin 82657-04-3 0.2 ppm Boscalid 188425-85-6 0.4 ppm Carbaryl 63-25-2 0.2 ppm Carbofuran 1563-66-2 0.2 ppm Chlorantraniliprole 500008-45-7 0.2 ppm Chlorfenapyr 122453-73-0 1.0 ppm Chlormequat chloride 7003-89-6 0.2 ppm Chlorpyrifos 2921-88-2 0.2 ppm Clofentezine 74115-24-5 0.2 ppm Cyfluthrin 68359-37-5 1.0 ppm Cypermethrin 52315-07-8 1.0 ppm Daminozide 1596-84-5 1.0 ppm DDVP (Dichlorvos) 62-73-7 0.1 ppm Diazinon 333-41-5 0.2 ppm Destroy Dimethoate 60-51-5 0.2 ppm Ethoprophos 13194-48-4 0.2 ppm Etofenprox 80844-07-1 0.4 ppm Etoxazole 153233-91-1 0.2 ppm Fenoxycarb 72490-01-8 0.2 ppm Fenpyroximate 134098-61-6 0.4 ppm Fipronil 120068-37-3 0.4 ppm Flonicamid 158062-67-0 1.0 ppm Fludioxonil 131341-86-1 0.4 ppm Hexythiazox 78587-05-0 1.0 ppm Imazalil 35554-44-0 0.2 ppm Imidacloprid 138261-41-3 0.4 ppm Kresoxim-methyl 143390-89-0 0.4 ppm Malathion 121-75-5 0.2 ppm Metalaxyl 57837-19-1 0.2 ppm Methiocarb 2032-65-7 0.2 ppm Methomyl 16752-77-5 0.4 ppm Methyl parathion 298 -00 - 0 0.2 ppm Myclobutanil 88671-89-0 0.2 ppm Naled 300-76-5 0.5 ppm Oxamyl 23135-22-0 1.0 ppm Paclobutrazol 76738-62-0 0.4 ppm Permethrins (measured as the cumulative residue of cis- and trans-isomers) 52645-53- 1(54774-45-7 and 51877-74-8) 0.2 ppm Phosmet 732-11-6 0.2 ppm Piperonyl_butoxide 51-03-6 2.0 ppm Prallethrin 23031-36-9 0.2 ppm Propiconazole 60207-90-1 0.4 ppm Propoxur 114-26-1 0.2 ppm Pyrethrins (measured as the cumulative residue of pyrethrin 1, cinerin 1 and jasmolin 1) 8003-34-7(121- 21-1, 25402-06-6, and 4466-14-2) 1.0 ppm Pyridaben 96489-71-3 0.2 ppm Spinosad 168316-95-8 0.2 ppm Spiromesifen 283594-90-1 0.2 ppm Spirotetramat 203313-25-1 0.2 ppm Spiroxamine 118134-30-8 0.4 ppm Tebuconazole 107534-96-3 0.4 ppm Thiacloprid 111988-49-9 0.2 ppm Thiamethoxam 153719-23-4 0.2 ppm Trifloxystrobin 141517-21-7 0.2 ppm E. Potency Analyte Labeling Required Action Tetrahydro- cannabinolic acid (THC-A) Label claim is not within ±10 % of tested value Revise label as necessary Delta-9- tetrahydrocannabinol (Ī”9- THC) Cannabidiolic acid (CBD-A) Cannabidiol (CBD) Terpenoids (primary and secondary) Label claim is not within ±10 % of tested value Revise label as necessary F. Moisture Content and Water Activity Testing Measurement Allowable Measurement Required Action Water activity ˃ 0.65 Aw Destroy Moisture content ˃ than 15% Remediate and retest Table 2 Quality Control Sample Acceptance Criteria Frequency Positive control Produces expected result, positive result Per Batch Negative control Produces expected result, negative result Per Batch Duplicate sample Results shall concur Per Run Analyst or technician Quantitative Performance Plate count comparisons monthly Within 10% for all analysts Monthly Table 3 Quality Control Sample Acceptance Criteria Corrective Action Positive control Produces expected result, positive result Re-prep and reanalyze the entire analytical batch, once. If problem persists, locate and remedy the source of unexpected result, then re- prep samples and reanalyze with a new set of controls. Negative control Produces expected result, negative result Re-prep and reanalyze the entire analytical batch, once. If problem persists, locate and remedy the source of unexpected result, then re- prep samples and reanalyze with a new set of controls. Laboratory replicate sample Sample results shall concur Reanalyze sample and associated replicate sample once. If problem persists, re-prep samples and reanalyze. Table 4 Quality Control Sample Acceptance Criteria Corrective Action Method Blank Sample Not to exceed LOQ Reanalyze entire analytical batch once. If method blank is still greater than the LOQ for any analyte, locate the source of contamination then re-prep samples and reanalyze. Laboratory Control Sample RPD ≤20% Reanalyze the entire analytical batch, once. If problem persists, re-prep samples and reanalyze or re-run the initial calibration curve. Duplicate Sample RPD ≤20% Reanalyze sample and associated replicate sample once. If problem persists, re-prep samples and reanalyze. Matrix Spike Sample/Matrix Spike Duplicate RPD ≤20% Reanalyze sample and associated matrix spike sample once. If problem persists, re-prep samples and reanalyze. CCV RPD ≤20% except for lowest point, which can be ±30% Reanalyze all samples that followed the last CCV that met the acceptance criteria. If CCV still fails, re-run the initial calibration curve and all samples in the analytical sequence. APPENDIX B SCHEDULE OF DISCIPLINARY ACTIONS Violation Penalty Unit of Measurement Failure of an employee to possess an active work permit $5,000 Each employee found without an active work permit. Employment of person under the age of $5,000 Each employee found under the age of 21. Failure to assist Department during recall of product $5,000 Each directive from the Department regarding recall. Failure to comply with security requirements $5,000 Each security deficiency related to Rules in this Part. On-site use of cannabis by employee(s) of medical cannabis establishment $5,000 Each employee using cannabis on premises of the medical cannabis establishment. Failure to sufficiently maintain records $10,000 Each deficiency/finding related to recordkeeping to Rules in this Part. Unlawful acquisition, transfer, purchase or sale of cannabis and/or cannabis product(s) $10,000 Each instance of acquisition, transfer, purchase or sale. Failure to accurately track inventory $10,000 and/or one-week suspension and/or destruction of product Each untagged plant, package and/or batch at the time of the Department’s finding. Falsification of records $10,000 and/or one week suspension Each instance of falsification of records required under Rules in this Part. Refusal to permit access by Department staff as required by law Two-week suspension Instance/Occurrence documented at the time of requested access. Threat against law enforcement and/or Department staff Two-week suspension Instance/Occurrence documented at the time of the threat. Cultivation activities during a license suspension period Revocation Cultivation activities that would include (but not limited to) any planting, drying, harvesting, and/or packaging during the dates of suspension and any administrative appeal. Processing activities during a license suspension period Revocation Activities related to processing during the dates of suspension and any administrative appeals. Transportation activities during a license suspension period Revocation Transportation activities that would include during the dates of suspension and any administrative appeal. Disposal/Destruction activities during a license suspension period  Revocation  Any disposal activities during the dates of suspension and any administrative appeal. General penalty for any violation/infraction not specifically listed in this Table $5,000 Each instance and/or finding to be specifically identified by the Department. APPENDIX C RULES AND PROCEDURES FOR ADMINISTRATIVE HEARINGS 1. Hearing Officer: The Hearing Officer shall be appointed by the State Health Officer or his/her designee. The Hearing Officer shall preside at the hearing, shall be charged with maintaining order at the hearing, and shall rule on all questions of evidence and procedure in accordance with the provisions of these rules. 2. Appearance by Licensee/Aggrieved party: The licensee/aggrieved party shall appear at the date and time set for the hearing, and failure to do so without reasonable notice to the Department may result in admission of the charges and adverse action taken against the licensee. 3. Representation by Counsel: The licensee/aggrieved party may, but is not required to be, represented by counsel at the hearing at his/her own expense and shall have the right to cross- examine all witnesses, present evidence, written or oral, on his/her own behalf, and to refute any testimony or evidence presented by the Department. 4. Confidentiality of Hearings: Administrative hearings before a Hearing Officer are considered confidential and are not open to the public. 5. Rules of Evidence and Discovery: Formal rules of evidence and procedure, including Discovery, do not apply in administrative hearings; however, the rules of evidence may be used as a guide during the hearing. A record of the hearing shall be made by a court reporter. 6. Attendance of Witnesses: The licensee/aggrieved party or counsel for the Department may make a written request to the Hearing Officer at least ten (10) days prior to the hearing to ensure the attendance of a witness or the production of documents through the issuance of an administrative subpoena. The issuance of the subpoena shall be at the discretion of the Hearing Officer. 7. Order of Proceedings: The Department shall present its case first, followed by the licensee/aggrieved party, and any rebuttal evidence by either party. At the request of either party, all prospective witnesses shall be excluded from the proceedings except while actually testifying. 8. Standard of Proof: In order for the Department’s decision to be overturned, the Hearing Officer shall find that the regulatory violation and/or disciplinary action is (a) arbitrary or capricious; (b) unsupported by substantial evidence; (c) beyond the power of the administrative agency to make; or (d) violated some statutory or constitutional right of the aggrieved party. 9. Recommendation and Final Decision/Final Order: Within thirty (30) days of the hearing, or such period as determined at the hearing considering the amount of testimony and evidence and the complexity of the issues, the Hearing Officer shall submit his/her ā€œFindings of Fact, Conclusions of Law and Recommendationā€ to the State Health Officer, outlining the proof presented and containing his/her recommendation to the State Health Officer as to the appropriate action to be taken. The State Health Officer shall issue his/her Final Order adopting, modifying, or rejecting the Recommendation within fourteen (14) days of receipt of the recommendation. This Final Order becomes the final appealable order of the Mississippi State Department of Health as to those proceedings. 10. Appeal of the Department’s Final Order shall be accomplished as provided by the appropriate statute. 11. Any person or entity who disagrees with or is aggrieved by the Final Decision or Final Order of the Department concerning the imposition of fine(s) and/or other sanction(s). suspension, or revocation of a license may appeal same in the circuit court of the county in which he/she resides. If the aggrieved party is a nonresident of this state, he/she may appeal to the Circuit Court of the First Judicial District of Hinds County, Mississippi. The appeal shall be filed no later than twenty (20) calendar days after the issuance of the Final Decision or Order by the Department. 12. Any person or entity aggrieved by the decision of the circuit court may appeal to the Mississippi Supreme Court. 13. If the licensee/aggrieved party fails to appeal the Final Order within the prescribed time, the decision becomes final and cannot be further appealed.
15 MAC Pt. 22, R. 3.2.2: B | Justis AI