4 Del. Admin. Code § 5001-6.0

Current through Reigster Vol. 28, No. 6, December 1, 2024

Section 5001-6.0 - General Compliance

6.1 Ownership requirements

6.1.1 A social equity license may not be transferred to a person who does not meet the criteria in 4 Del.C. § 1336 until at least 3 years have passed since the social equity license was initially awarded.

6.1.2 A change ownership of a license must meet the requirements in 4 Del.C. § 1372 and this regulation.

6.2 General facility requirements

6.2.1 Marijuana establishments must ensure that their premises comply with all applicable local laws, regulations, and zoning requirements.

6.2.2 Marijuana establishments that handle or otherwise conduct activities with food, food ingredients, or food products must comply with all applicable requirements in the State of Delaware Food Code.

6.2.3 Marijuana establishments must ensure that their premises complies with all applicable federal workplace safety laws and regulations in accordance with the General Duty Clause of the OSH Act (Public Law 91-956) and 29 C.F.R. provided by the Occupational Safety and Health Administration (OSHA), including:

6.2.3.1 The presence of functioning fire and smoke detection systems, and, where applicable, fire suppression systems;

6.2.3.2 The presence of functioning carbon monoxide detection systems;

6.2.3.3 The prominent display of emergency procedures, including evacuations and shelter-in-place procedures;

6.2.3.4 Personnel access to procedures for the safe handling and operation of any applicable equipment or tools; and

6.2.3.5 Any other applicable federal, state, or local laws and regulations pertaining to workplace safety.

6.2.4 Marijuana establishments must ensure compliance with all applicable rules, regulations, and standards contained in:

6.2.4.1 National Fire Protection Association (NFPA) standards;

6.2.4.2 International Building Code (IBC); and

6.2.4.3 International Fire Code (IFC).

6.3 General security requirements

6.3.1 Marijuana establishments must ensure that all usable marijuana plants, marijuana, and marijuana products are stored in a locked and secured area.

6.3.2 Marijuana establishments must implement appropriate security and safety measures to deter and prevent the unauthorized entrance into areas containing marijuana plants, marijuana, and marijuana products, and the theft or diversion of marijuana plants, marijuana, and marijuana products. Security and safety measures must include the following:

6.3.2.1 Access to the premises

6.3.2.1.1 Access from outside the premises must be closely monitored and limited to primary entry points.

6.3.2.1.2 Entry into any area where marijuana plants, marijuana, or marijuana products are held must be limited to authorized personnel.

6.3.2.1.3 Visitors, repair and maintenance workers must be supervised in restricted areas;

6.3.2.1.4 Commercial grade locks appropriate for facilities requiring high levels of physical security are required on all perimeter entry doors.

6.3.2.1.5 All external entrances to indoor facilities on the premises must be lockable.

6.3.2.1.6 All perimeter windows must be in good condition and lockable.

6.3.2.2 Alarm system

6.3.2.2.1 The alarm system must be fully operational at all premises.

6.3.2.2.2 The alarm system must immediately alert a licensed third-party security company of an unauthorized breach of security.

6.3.2.2.3 The alarm system must include an audible alarm capable of being disabled remotely by the security company.

6.3.2.2.4 The alarm system must immediately send an automatic or electronic notification to local or municipal public safety personnel in the event of a loss of electrical support backup system.

6.3.2.2.5 The alarm system must prevent tampering with computers or electronic records.

6.3.2.2.6 Marijuana establishments must conduct a maintenance inspection and test of the alarm system at intervals no more than 30 days from the previous inspection or test. A marijuana establishment must promptly make all necessary repairs to ensure the proper operation of the alarm system.

6.3.2.3 Lighting. Any perimeter entry point of a marijuana establishment must have lighting sufficient for observers to see, and cameras to record, any activity within 10 feet of the gate or entry to the premises.

6.3.2.4 Video surveillance

6.3.2.4.1 A sufficient number of cameras must be permanently affixed to allow the viewing, in its entirety, of any area where marijuana plants, marijuana, or marijuana products are cultivated, manufactured, stored, or prepared for transfer or sale, or where samples for testing are collected, prepared, and sealed.

6.3.2.4.2 Video surveillance must meet the following requirements:

6.3.2.4.2.1 Minimum camera resolution is 720p;

6.3.2.4.2.2 All cameras must record continuously 24 hours per day or be motion activated and at a minimum of 15 frames per second;

6.3.2.4.2.3 All recorded images must clearly and accurately display the time and date. Time is to be measured in accordance with the U.S. National Institute Standards and Technology standards;

6.3.2.4.2.4 An electronic hard drive or comparable electronic storage device used only for the storage of surveillance system video footage must be secured on the premises, be on a third-party server, or be secured in another manner to protect from tampering or criminal theft; and

6.3.2.4.2.5 Video footage must be digitally recorded and held for 90 days for routine footage or up to 36 months if video contains information of significance.

6.3.2.4.3 A marijuana establishment must provide the Commissioner with access to the video 24 hours a day, 7 days a week through a secure internet connection.

6.3.2.5 In the event of a failure of an alarm or video surveillance system due to loss of electrical support or mechanical malfunction that is expected to exceed an 8-hour period, marijuana establishments must:

6.3.2.5.1 Notify the Commissioner within 24 hours;

6.3.2.5.2 Provide alternative security measures approved by the Commissioner, or close the authorized physical addresses impacted by the failure or malfunction until the alarm or video surveillance systems have been restored to full operation;

6.3.2.5.3 Maintain documentation for a period of at least 24 months after the event. The documentation must include:

6.3.2.5.3.1 All maintenance inspections and tests conducted on the alarm or video surveillance system;

6.3.2.5.3.2 Any servicing, modification, or upgrade performed on the alarm or video surveillance system;

6.3.2.5.3.3 The date of the action;

6.3.2.5.3.4 A summary of any actions performed; and

6.3.2.5.3.5 The name, signature, and title of the individual who performed the actions.

6.3.2.6 Marijuana establishments must maintain documentation for any alarm activation or other event which requires response by public safety personnel, and any unauthorized breach of security.

6.3.3 Theft and diversion. If a marijuana establishment discovers evidence of theft or diversion, the marijuana establishment must report the theft or diversion to the Commissioner and law enforcement within 1 business day. Within 30 business days of discovering the discrepancy, the marijuana establishment must:

6.3.3.1 Complete an investigation;

6.3.3.2 Amend the marijuana establishment's standard operating procedures, if directed by the Commissioner; and

6.3.3.3 Send a report of the investigation to the Commissioner.

6.4 General conduct of marijuana establishments

6.4.1 Marijuana establishments must conduct monthly inventories in accordance with the following:

6.4.1.1 On the date business commences, the marijuana establishment must conduct an initial comprehensive inventory review of all marijuana plants, marijuana, and marijuana products at all premises;

6.4.1.2 Documentation of all inventory reviews shall include, at a minimum, the date of the inventory, a summary of the inventory findings and the name, signature, and title of the individual or individuals who conducted the inventory; and

6.4.1.3 If an inventory review identifies a discrepancy, the marijuana establishment must notify the Commissioner within 24 hours of discovery of the event.

6.4.2 Marijuana establishments must maintain a current and accurate copy of an operating manual that includes:

6.4.2.1 Procedures for the oversight of the marijuana establishment, including documentation of the reporting and management structure of the marijuana establishment;

6.4.2.2 Procedures for the safe handling of marijuana plants, marijuana, and marijuana products;

6.4.2.3 Procedures to ensure accurate record keeping, including protocols to ensure that quantities of marijuana and marijuana products purchased do not suggest re-distribution;

6.4.2.4 Personnel security policies;

6.4.2.5 Safety and security procedures, including requirements in accordance with subsection 6.3 of this regulation, and including a disaster plan with procedures to be followed in case of fire or other emergencies;

6.4.2.6 Personal safety and crime prevention techniques;

6.4.2.7 Job descriptions or employment contracts developed for all employees and volunteer agreements for all volunteers which includes duties, responsibilities, authority, qualifications, and supervision;

6.4.2.8 The marijuana establishment's alcohol and drug free workplace policies;

6.4.2.9 Procedures to prevent theft or diversion;

6.4.2.10 A business continuity plan; and

6.4.2.11 Any additional operating manual requirements for the marijuana establishment's respective license type.

6.4.3 Personnel training. Marijuana establishments must develop, implement, and maintain on the premises an on-site training curriculum, or enter into contractual arrangements with outside resources capable of meeting personnel training requirements. All personnel must receive training in the following prior to commencing work on behalf of the marijuana establishment:

6.4.3.1 Proper use of security measures and controls that have been adopted by the marijuana establishment; and

6.4.3.2 Specific procedures for responding to an emergency, including accident, robbery, active shooter, or violent incident.

6.4.4 Employment identification badge

6.4.4.1 All personnel must have an employment identification badge issued by the Commissioner that permits the individual to conduct activities on behalf of the marijuana establishment. Employment identification badges must be visible on the individual's person at all times the individual is conducting activities on behalf of the marijuana establishment.

6.4.4.2 Applications for an employment identification badge must be submitted on forms made available by the Commissioner. Every applicant must be fingerprinted and complete a criminal history background check.

6.4.4.3 The Commissioner may deny an employment identification badge to any individual who:

6.4.4.3.1 Has been convicted of an offense listed in 4 Del.C. § 1354(b)(4);

6.4.4.3.2 Does not provide sufficient documentation that the individual is 21 years of age or older; or

6.4.4.3.3 In the Commissioner's discretion, based on information collected in the criminal background check process, presents a risk to the health or public safety of Delaware citizens.

6.4.4.4 Employment identification badges must be renewed every 2 years in accordance with the following:

6.4.4.4.1 An application for renewal of an employment identification badge must be submitted prior to the expiration date, and no earlier than 60 days before the expiration date.

6.4.4.4.2 If an application for renewal of an employment identification badge has been submitted before the expiration date, but has not been processed by the Commissioner, personnel may conduct activities on behalf of the marijuana establishment until the new employment identification badge has been issued.

6.4.4.5 Employment identification badges for which a renewal application has not been received by the Commissioner will expire. Personnel with an expired badge may not conduct any activities on behalf of the marijuana establishment.

6.4.4.6 If an employment identification badge is lost or stolen, the marijuana establishment must notify the Commissioner within 24 hours. After notification, the Commissioner will indicate whether the badge holder may continue to conduct activities on behalf of the marijuana establishment.

6.4.4.7 Marijuana establishments must notify the Commissioner within 48 hours of the termination of the personnel's affiliation with the marijuana establishment. The marijuana establishment must follow instructions from the Commissioner for return of the employment identification badge.

6.4.4.8 The Commissioner may charge a fee for the issuance or replacement of an employment identification badge.

6.4.5 Marijuana establishments must conduct annual financial audits. The audit must be conducted by an independent auditing firm and submitted to the Commissioner with the marijuana establishment's annual report. The Commissioner or an auditing firm contracted by the Commissioner must have access to all books and records kept by any marijuana establishment at all times.

6.4.6 Prohibited conduct. Marijuana establishments may not:

6.4.6.1 Purchase marijuana plants, marijuana, or marijuana products from any person or entity other than another marijuana establishment licensed by the State of Delaware;

6.4.6.2 Sell or prepare products from a batch undergoing mandatory compliance testing until the marijuana testing facility has entered the applicable values into the seed-to-sale tracking system; or

6.4.6.3 Operate if an imminent health hazard exists due to an emergency such as fire, flood, extended interruption of electrical or water service, sewage backup, misuse of poisonous or toxic materials, onset of an apparent food-borne illness outbreak, gross unsanitary occurrences or conditions, or other circumstances that may endanger public health.

6.4.7 Visitor logs. Marijuana establishments must document and retain records following the entry of any individual not affiliated with the marijuana establishment into any area of the premises that is not accessible to the public.

6.4.7.1 Visitor logs must include the full legal name and signature of the visitor, the visitor's phone number, the date of the visitation, and a check-in and check-out time.

6.4.7.2 If the visitor is a holder of an active employment identification badge under this regulation, the visitor log must include the individual's unique identification number.

6.4.7.3 Visitor logs must be maintained for a period of 1 year following the date of visitation.

6.5 Retail marijuana store general requirements

6.5.1 A retail marijuana store license permits the following activities:

6.5.1.1 Purchasing prepackaged retail units of marijuana from marijuana cultivation facilities;

6.5.1.2 Purchasing prepackaged retail units of marijuana, marijuana concentrates, and marijuana products from marijuana products manufacturing facilities;

6.5.1.3 Selling prepackaged retail units of marijuana, marijuana concentrates, and marijuana products, to consumer 21 years or older or with a valid medical marijuana program card;

6.5.1.4 Providing samples of marijuana and marijuana products to authorized individuals for mandatory compliance testing in accordance with subsection 11.2 at the direction of the Commissioner;

6.5.1.5 Collecting samples of marijuana for research and development testing in accordance with subsection 11.7 and transporting those samples to a marijuana testing facility;

6.5.1.6 Storing prepackaged retail units of marijuana, marijuana concentrates, and marijuana products;

6.5.1.7 Selling marijuana accessories and non-consumable products that are not intended for human consumption, including clothing, storage containers, rolling papers, or other marijuana accessories.

6.5.1.8 Transporting prepackaged retail units of marijuana, marijuana concentrates, or marijuana products to other marijuana establishments; and

6.5.1.9 Destroying marijuana, marijuana concentrates and marijuana products in accordance with subsection 12.2.

6.5.2 A retail marijuana store is prohibited from:

6.5.2.1 Selling marijuana, marijuana concentrates, and marijuana products to a person under 21 years of age without a valid medical marijuana program card;

6.5.2.2 Selling more marijuana, marijuana concentrates, and marijuana products than is allowed for in 4 Del.C. § 1332 and this regulation, during a single transaction to an individual;

6.5.2.3 Giving away marijuana, marijuana concentrates, and marijuana products for no remuneration;

6.5.2.4 Selling any marijuana, marijuana concentrates, and marijuana products which contain synthetic cannabinoids;

6.5.2.5 Selling marijuana, marijuana concentrates, and marijuana products to a person who is visibly intoxicated;

6.5.2.6 Displaying marijuana products in an insecure manner or in a manner that products can be viewed from outside the establishment;

6.5.2.7 Selling or giving away consumable products not containing marijuana, including cigarettes or alcohol, or any edible product that does not contain marijuana, including sodas, candies, or baked goods;

6.5.2.8 Selling retail marijuana or retail marijuana products over the Internet. This does not preclude online pre-orders for pick-up at the retail location, provided that the sale is not completed until all other requirements have been met, including identity and age verification; and

6.5.2.9 Delivering retail marijuana or retail marijuana products to a person not physically present in the retail marijuana store's licensed premises. Individuals holding a valid medical marijuana program card may receive home delivery.

6.5.3 A retail marijuana store must:

6.5.3.1 Ensure all sales of marijuana and marijuana products take place within the retail area of the retail marijuana store premises;

6.5.3.2 Prohibit the consumption of marijuana or marijuana products on the premises of the retail marijuana store;

6.5.3.3 Comply with all provisions of Delaware and federal law in regard to individuals with disabilities;

6.5.3.4 Prominently display the active retail marijuana store license where it can reasonably be viewed by state and local agencies and the public;

6.5.3.5 In addition to the training requirements described in subsection 6.4.3 of this regulation, ensure all employees are trained in recognizing valid identification cards; and

6.5.3.6 Verify customer age by reviewing the purchaser's government-issued photo identification card showing that the individual is 21 years of age or older or holds a valid medical marijuana program card. A valid, government-issued identification must contain a photo and the date of birth of the individual and be unexpired. Valid forms of government-issued identification include:

6.5.3.6.1 A driver's license issued by any state within the United States, District of Columbia, or U.S. territory;

6.5.3.6.2 An identification card, including a temporary identification card, issued by any state within the United States, District of Columbia, or U.S. territory;

6.5.3.6.3 A United States military identification card or any other identification card issued by the United States government including a permanent resident card, alien registration card, or consular card;

6.5.3.6.4 A passport or passport identification card; or

6.5.3.6.5 A tribal enrollment card issued by the governing authority of a federally recognized Indian tribe.

6.5.4 Retail marijuana store operating plan. Retail marijuana stores must maintain a current and accurate copy of an operating plan that includes:

6.5.4.1 Procedures for recognizing valid identification cards, including the duties and responsibilities of employees when presented with fraudulent identification by an individual under the age of 21;

6.5.4.2 Procedures for the safe handling of marijuana and marijuana products available for sale;

6.5.4.3 Requirements for the record keeping and disposal of marijuana and marijuana products removed from their original packaging for the purposes of displaying products available for sale; and

6.5.4.4 Procedures for the monthly inventory review of all marijuana and marijuana products for sale in accordance with subsection 7.1.2 of this regulation.

6.5.5 Display of marijuana and marijuana products. Marijuana and marijuana products available for sale at a retail marijuana store must be displayed:

6.5.5.1 In a manner that is not visible to the general public from a public right-of-way;

6.5.5.2 In a locked display case or container that can only be accessed with the assistance of an employee of the retail marijuana store.

6.5.5.2.1 A display case containing marijuana or marijuana products must include the potency of the marijuana or marijuana products next to the name of the marijuana or marijuana products using the standards established by Section 9.0 of this regulation.

6.5.5.2.2 If an individual wishes to inspect marijuana or a marijuana product located in a display case, an employee of the retail marijuana store must assist the individual and remain with them at all times while the product is being inspected.

6.5.5.2.3 Marijuana and marijuana products may be removed from their packaging and placed in a display case or container but may not be sold or consumed when the marijuana or marijuana product is no longer being used for display purposes.

6.5.6 A retail marijuana store may petition the Commissioner to allow deli style dispensing of marijuana flower. The Commissioner will consider the petition weighed against the health and public safety of consumers. The petition must demonstrate compliance with Section 9.0 of this regulation and include:

6.5.6.1 A detailed plan for selling unpackaged marijuana flower safely, without undue exposure to ubiquitous airborne contaminates;

6.5.6.2 A detailed plan for security and inventory control; and

6.5.6.3 A wholesale agreement with a licensed marijuana establishment providing marijuana flower.

6.5.7 Retail marijuana store security requirements

6.5.7.1 Retail area. A retail marijuana store must have a retail area where marijuana, marijuana products, or marijuana accessories are offered for sale. The retail area must:

6.5.7.1.1 Be physically separated from the waiting area; and

6.5.7.1.2 Be locked and accessible to customers only through permission by a retail marijuana store employee. A retail marijuana store employee may provide access by physically or remotely unlocking the entrance to the retail area for purposes of allowing a customer to enter the retail area.

6.5.7.2 Waiting area. A retail marijuana store must have a waiting area where marijuana, marijuana products, and marijuana accessories are not present. The waiting area must:

6.5.7.2.1 Be physically separated from the retail area;

6.5.7.2.2 Be the area first accessed by customers upon entrance into the premises;

6.5.7.2.3 Include a reception area where an employee of the retail marijuana store verifies that the purchaser has a valid government-issued photo identification card showing that the individual is 21 years of age or older; and

6.5.7.2.4 Be attended by a retail marijuana store employee at all times during operating hours.

6.6 Marijuana testing facilities general requirements

6.6.1 A marijuana testing facility license permits the following activities:

6.6.1.1 Receiving samples of marijuana and marijuana products from individuals authorized by the Commissioner for the purpose of required compliance testing;

6.6.1.2 Receiving samples of marijuana and marijuana products from marijuana cultivation facilities, marijuana product manufacturing facilities, retail marijuana stores, and individuals authorized by the Commissioner for the purpose of research and development;

6.6.1.3 Denying receipt of samples from to marijuana cultivation facilities, marijuana product manufacturing facilities, and retail marijuana stores, for any reason, including samples that do not meet the requirements of subsection 11.9;

6.6.1.4 Performing analysis of samples of marijuana and marijuana products following protocols approved by the Commissioner and in accordance with subsection 11.10;

6.6.1.5 Providing a Certificate of Analysis, for the sample provided to the marijuana testing facility, to marijuana cultivation facilities, marijuana product manufacturing facilities and retail marijuana stores;

6.6.1.6 Storing samples of marijuana and marijuana products;

6.6.1.7 Destroying and disposing of samples, subject to all requirements of subsection 12.2;

6.6.1.8 Reporting of testing results in accordance with subsections 11.5 and 11.10.9; and

6.6.1.9 Receiving samples of marijuana, marijuana concentrates, and marijuana products from individuals holding a valid medical marijuana program card or consumers 21 years or older, for the purpose of testing.

6.6.2 A marijuana testing facility must:

6.6.2.1 Operate in accordance with the International Organization for Standardization 17025 (ISO 17025) standards as confirmed by accreditation or by an International Laboratory Accreditation Corporation (ILAC) recognized accreditation body.

6.6.2.2 Meet the requirements specified in Sections 3.0 and 4.0 of this regulation.

6.6.3 Active licenses for marijuana testing facilities:

6.6.3.1 May not be issued prior to a final inspection and correction of any deficiencies in a manner acceptable to the Commissioner;

6.6.3.2 Must be kept posted in a conspicuous place on the premises;

6.6.3.3 Must clearly identify the name of the laboratory, the license number, the name of the marijuana testing facility director, the issue date, and expiration date; and

6.6.3.4 Must include a list of the analytes and methods for each test category for which the marijuana testing facility is approved to conduct testing. Test categories approved for the analysis of marijuana plant materials must be listed separately from those approved for marijuana concentrates.

6.6.4 Marijuana testing facilities may examine samples from other marijuana testing facilities in this state, provided that the marijuana testing facility providing the samples is licensed in this state pursuant to this regulation.

6.6.5 Marijuana testing facilities may receive samples from private citizens for examination. The individual or individuals providing samples will be responsible for any cost associated with examination and testing of the samples. Results obtained through examination of samples provided by private citizens are not subject to the reporting requirements in this regulation.

6.6.6 Management. Each marijuana testing facility must have a director who is responsible for the day-to-day management and operation of the marijuana testing facility, and for ensuring the achievement and maintenance of quality standards of practice.

6.6.6.1 The marijuana testing facility director must possess a doctorate degree in the chemical or biological sciences from a college or university accredited by a national or regional certifying authority and a minimum of 2 years of analytical laboratory experience or possess a master's degree in the chemical or biological sciences and a minimum of 4 years of analytical laboratory experience or possess a bachelor's degree in the chemical or biological sciences and a minimum of 5 years of analytical laboratory experience.

6.6.6.2 The marijuana testing facility director's responsibilities include:

6.6.6.2.1 Being present on the premises of the marijuana testing facility during the hours of operation to ensure adequate and appropriate supervision of marijuana testing facility activities;

6.6.6.2.2 Ensuring the accurate performance of all tests in the marijuana testing facility including the submission of appropriate reports on all tests;

6.6.6.2.3 Ensuring the supervision of all personnel in the marijuana testing facility and for hiring adequately trained personnel commensurate with the workload;

6.6.6.2.4 Being available during the hours of operation for personal or telephone consultation with personnel;

6.6.6.2.5 Notifying the Commissioner within 30 days of any change in marijuana testing facility services or supervisory personnel; and

6.6.6.2.6 Establishing and adhering to written policies and procedures for a comprehensive quality assurance program.

6.6.6.3 In the event the director of the marijuana testing facility is absent for a continuous period longer than 1 month in duration, the marijuana testing facility may not operate unless a person who meets the qualifications of subsection 6.6.6.1 of this regulation is in attendance.

6.6.6.4 The marijuana testing facility director must designate a qualified quality assurance management officer who is responsible for the marijuana testing facility's quality assurance management plan and its implementation. This individual may be an outside consultant or the marijuana testing facility director. The quality assurance management officer must:

6.6.6.4.1 Have a bachelor's degree in a chemical or biological science and 2 years of related laboratory experience. The Commissioner may waive these qualifications if the person has previous laboratory quality assurance experience acceptable to the Commissioner in a licensed, certified, or accredited laboratory, or possesses other qualifications acceptable to Commissioner;

6.6.6.4.2 Be responsible for the oversight of quality control data, including establishing acceptance criteria, documenting, and monitoring corrective action;

6.6.6.4.3 Where staffing allows, be independent of the technical areas for which they have quality assurance oversight;

6.6.6.4.4 Have general knowledge of the methodologies for which data review is performed;

6.6.6.4.5 Have oversight of the marijuana testing facility's quality assurance system; and

6.6.6.4.6 Conduct or arrange for annual internal audits of the technical operation of the marijuana testing facility, and report findings to the marijuana testing facility director.

6.6.7 Personnel. Each marijuana testing facility must:

6.6.7.1 Employ enough qualified personnel commensurate with the workload to ensure that services are provided effectively and safely and in accordance with prevailing laboratory standards and practices;

6.6.7.2 Establish a job description for each classification of position, clearly delineating qualifications, duties, and responsibilities inherent in each position;

6.6.7.3 Maintain personnel records for all personnel which include:

6.6.7.3.1 Current background and training documentation pertaining to qualifications;

6.6.7.3.2 Orientation procedures, including an initial demonstration of capability for each method or instrument the personnel will be performing or operating;

6.6.7.3.3 Evidence of periodic evaluation of work performance.

6.6.7.4 Train personnel initially and annually thereafter on the following:

6.6.7.4.1 Professional conduct, ethics, and state laws regarding marijuana;

6.6.7.4.2 The use of the seed-to-sale tracking system used by the marijuana testing facility; and

6.6.7.4.3 Testing methods employed by the marijuana testing facility.

6.6.8 Record keeping. In addition to the requirements and processes specified in Section 7.0 of this regulation, each marijuana testing facility must:

6.6.8.1 Create, control, and maintain records of raw data, chain-of-custody records, calculations, quality control data, and other essential documentation;

6.6.8.2 Complete all records with signatures, units of measurement, and documentation sufficient for verification of results; and

6.6.8.3 Retain all records in such a manner as to permit prompt retrieval and inspection by the Commissioner.

6.6.9 Quality assurance and quality control programs. Each marijuana testing facility must:

6.6.9.1 Have a quality assurance management plan that details the quality assurance system of quality control requirements in its standard operating procedures, and document that all personnel review the quality assurance management plan annually. The quality assurance/management plan must include:

6.6.9.1.1 Sample handling procedures;

6.6.9.1.2 Emergency sampling and handling plans;

6.6.9.1.3 Laboratory glassware, plastic ware, and equipment washing and sterilizing procedures;

6.6.9.1.4 Instrument calibration procedures;

6.6.9.1.5 A list of detailed analytical procedures or analytical references;

6.6.9.1.6 Data reduction, validation, and reporting procedures including non-compliance action plans;

6.6.9.1.7 Types and frequency of internal audit samples (quality control samples) and external audit samples (proficiency testing samples);

6.6.9.1.8 Internal audit procedures and frequencies;

6.6.9.1.9 Preventative maintenance procedures and schedules;

6.6.9.1.10 Procedures for determining accuracy and precision and method detection limits of all analytes and specified frequencies;

6.6.9.1.11 Control limits and corrective action policies;

6.6.9.1.12 Marijuana testing facility organization, staff, and responsibilities;

6.6.9.1.13 Procedures for marijuana testing facility and managerial data review;

6.6.9.1.14 Detection limits for cannabinoids and contaminant analytes specified in this regulation. Detection limits must be determined by detection limit studies prior to placing new methods in service and annually thereafter. The resulting detection limits must be less than half of the upper limit concentration criteria specified in this regulation. If the marijuana testing facility cannot meet a detection limit that is less than half of the upper limit for an analyte, a request for a variance must be submitted; and

6.6.9.1.15 The applicable quality control procedures required for methodologies described by the FDA, AOAC, AHP or USP.

6.6.9.2 Follow all applicable quality control activities described in its quality assurance/management plan as approved by the Commissioner;

6.6.9.3 Review their quality assurance management plan annually and provide a copy of the updated quality assurance/management plan to the Commissioner with the annual license renewal application;

6.6.9.4 Have clearly established internal and external quality controls to ensure high standards of performance and reliability of test results. These quality controls must consider factors including preventative maintenance, periodic inspection, testing for proper validation of methods, evaluation of reagents and volumetric equipment, surveillance of results, remedial action taken to correct deficiencies, and quality control failures and other factors as may be deemed necessary by the Commissioner;

6.6.9.5 Perform all analyses using methods that are currently approved by the Commissioner;

6.6.9.6 Make its quality assurance/management plan accessible to all personnel in the marijuana testing facility.

6.6.10 Proficiency testing and demonstration of capability. Each marijuana testing facility must adhere to the following:

6.6.10.1 The marijuana testing facility's quality assurance management plan must include standard procedures for determining the capability of its analysts before they can begin conducting quantitative analysis of marijuana or marijuana products.

6.6.10.2 The Commissioner must be notified when significant changes are made to the standard analytical procedures such as changes to extraction techniques, or the instrumentation used.

6.6.10.3 All personnel are required to perform initial demonstration of capability prior to implementing routine analyses.

6.6.10.4 Each marijuana testing facility must participate in a proficiency testing program approved by the Commissioner for each analyte (or group of analytes), matrix, and method for which the marijuana testing facility is allowed to conduct or for which it is requesting allowance. Proficiency testing samples must be procured from a proficiency testing provider approved by the Commissioner. The Commissioner may require that the proficiency testing program include "round robin" proficiency testing whereby samples from the same batch are tested by more than 1 licensed marijuana testing facility for comparison of results.

6.6.10.4.1 If proficiency test samples are not commercially available, marijuana testing facilities must submit a plan to define and develop in-house quality control samples it will use to demonstrate its proficiency for each analyte, matrix, and method of analysis. The plan must include:

6.6.10.4.1.1 The source of the sample;

6.6.10.4.1.2 The matrix type;

6.6.10.4.1.3 Preparation procedures;

6.6.10.4.1.4 Target analytes in the sample;

6.6.10.4.1.5 How the analyte concentration was determined;

6.6.10.4.1.6 Control limits and how they were determined; and

6.6.10.4.1.7 Sample shelf life and expiration testing.

6.6.10.4.2 The laboratory must participate in a proficiency testing program annually for each analyte, matrix, and method and receive an acceptable evaluation for each test category described in this regulation.

6.6.10.4.3 Proficiency test results must be submitted by the accredited provider directly to the Commissioner by October 31 of each year. Marijuana testing facilities must designate the Commissioner as a recipient of the provider's proficiency test results report. Marijuana testing facilities may not communicate or receive proficiency test results to or from other marijuana testing facilities before the accredited provider makes them available.

6.6.10.4.4 When a marijuana testing facility receives an unacceptable evaluation for an analyte in a study, it must determine the cause for the failure, take corrective action, and participate in another proficiency testing study for the failed analyte. Documentation of the investigation and corrective must be maintained, and a copy provided to the Commissioner before the next proficiency testing study.

6.6.10.4.5 Failure to complete proficiency testing studies annually, or failure to obtain an acceptable result in a proficiency testing study will result in loss of approval for the testing of the analyte in question until 2 consecutive proficiency testing studies resulting in acceptable evaluations have been completed. There must be an interval of at least 30 days between the 2 studies.

6.6.10.4.6 All proficiency test samples must be analyzed in the same manner and frequency as real marijuana and marijuana products using the same staff, procedures, and equipment.

6.6.10.4.7 Marijuana testing facilities may not send a proficiency testing sample, or a portion thereof, to another marijuana testing facility for any analysis for which it is approved or seeking approval.

6.6.10.4.8 A marijuana testing facility may not knowingly receive any proficiency testing sample, or a portion thereof, from another marijuana testing facility for any analysis for which the sending marijuana testing facility is approved or seeking approval.

6.6.10.4.9 Marijuana testing facility management or personnel may not communicate with any individual at another marijuana testing facility concerning a proficiency testing sample or attempt to obtain the assigned value from their proficiency testing provider.

6.6.10.4.10 All raw data obtained in analyzing proficiency testing samples must be retained and be available for review for a minimum of 5 years.

6.6.11 Procedures manual. Each marijuana testing facility must have available at all times, in the immediate working areas of personnel engaged in conducting analytical laboratory sample receiving, sample accessioning, and testing, a procedures manual which includes a detailed compilation of all automated and manual methods and procedures for chain-of-custody, and analytical testing which is performed by the laboratory and for which it is approved. Procedures manuals must:

6.6.11.1 Be written in a uniformly consistent format;

6.6.11.2 Specify the approved method used;

6.6.11.3 Describe the quality control activities pertinent to the method;

6.6.11.4 Contain information concerning preparation and storage of media, reagents, control and calibration procedures, and pertinent literature references;

6.6.11.5 Describe the marijuana testing facility's technical procedures for the receiving, processing, and examination of samples;

6.6.11.6 For tests which are normally performed on automated test equipment, provide for alternate methods or for storage of test samples, in the event the automated equipment becomes inoperable; and

6.6.11.7 Be approved, signed, and dated by the current marijuana testing facility director and the quality assurance/management officer. Changes in procedures must be approved, signed, and dated by the current marijuana testing facility director and the quality assurance/management officer.

6.6.12 Waste disposal. In addition to the requirements and processes specified in Section 12.0 of this regulation, each marijuana testing facility must:

6.6.12.1 Manage medical waste per Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management & Disposal of Regulated Medical Waste in Delaware (7 DE Admin. Code 1302, Part 262 Standards Applicable to Generators of Hazardous Waste); and

6.6.12.2 Manage hazardous waste per DNREC rules and regulations.

6.6.13 Prohibited conduct. Marijuana testing facilities must adhere to the following requirements:

6.6.13.1 No marijuana testing facility or owner, officer, director, manager, general partner, or employee of a marijuana testing facility may have a direct or indirect financial interest in a marijuana cultivation facility, marijuana product manufacturing facility, or retail marijuana store.

6.6.13.2 A marijuana testing facility may not transfer any marijuana, marijuana products, or samples to any person or entity other than the person or entity who provided the sample, a law enforcement officer authorized to collect the marijuana or marijuana product, or another licensed marijuana testing facility with a valid license to perform the testing requested, or the Commissioner.

6.6.13.3 No owner, officer, director, manager, general partner, contractor, or employee of a marijuana testing facility may accept any gifts of goods, services, or money from a marijuana cultivation facility, marijuana product manufacturing facility, retail marijuana store, or a person or an organization representing the entities.

6.6.13.4 A marijuana testing facility must maintain the confidentiality of test results and may not report test results with any identifying information to anyone other than the person or entity who submitted the sample, law enforcement officers authorized to collect the information, the CDC, or the Commissioner.

6.6.13.5 No employee of a marijuana testing facility may alter the results of any test. In cases in which a sample was retested in accordance with Section 11.0 of this regulation, both test results must be maintained.

6.6.13.6 No employee of a marijuana testing facility may conceal from the Commissioner the results of any mandatory test for cannabinoid content or contamination.

6.6.13.7 A marijuana testing facility must maintain its accreditation at all times for at least 1 analyte and technology required as part of mandatory compliance testing to remain licensed by the Commissioner.

6.6.14 Marijuana testing facilities security requirements

6.6.14.1 Facility requirements. Each marijuana testing facility must adhere to the following:

6.6.14.1.1 Be housed in well-lighted, sanitary, vented quarters equipped with hot and cold running water and bathroom facilities, and contain ample space to process and examine the samples commensurate with the total workload;

6.6.14.1.2 Be in distinct and separate locations from living quarters unless provisions exist for separate entrances, and plumbing fixtures;

6.6.14.1.3 Have ample workbench space, have sufficient water, gas, suction, electrical outlets, and sinks;

6.6.14.1.4 Have adequate and proper storage space for all chemicals including explosive, flammable, corrosive, and caustic materials;

6.6.14.1.5 Have flooring composed of non-porous material in laboratory areas where acids, caustics, and solvents are used;

6.6.14.1.6 Have adequate temperature and humidity controls as may be required for proper performance of tests and operation of instruments affected by environmental conditions;

6.6.14.1.7 Have adequate electrical supply; and

6.6.14.1.8 Have adequate refrigeration for samples, standards, and reagents used in testing.

6.6.14.2 Equipment and supplies. Each marijuana testing facility must adhere to the following:

6.6.14.2.1 Possess on-site all equipment necessary for the testing method.

6.6.14.2.2 Have sufficient glassware and plastic lab-ware necessary for the analyses. Glassware shall be borosilicate glass or other corrosion-resistant glass and free of cracks and chips.

6.6.14.2.3 Markings and etchings shall be legible. Volumetric flasks, pipettes, and other glassware used for volumetric analysis shall be class "A".

6.6.14.2.4 The marijuana testing facility must have sufficient facilities to wash and sterilize glassware, lab-ware, and other containers used in the analyses.

6.6.14.2.5 All precision equipment and instruments (e.g., pipettes, pH meters, conductivity meters) must be calibrated and checked for accuracy at regular intervals as required by the method and the marijuana testing facility's quality assurance policies. Documentation of calibration and accuracy checks must be maintained. Records of service by a qualified instrument service organization shall be maintained.

6.6.14.2.6 Analytical balance range and sensitivity must be appropriate for the application for which it is used. Balances must be kept clean and free of corrosion and spillage and shall be checked daily with weights meeting ASTM Type I, Class 1 or 2 specifications with values that bracket the laboratory's weighing needs. Records must be maintained that include acceptance criteria for the checks. ASTM weights shall be recalibrated every 5 years or immediately if nicked or corroded. Non-reference weights may be used but must be calibrated every 6 months against ASTM type 1, 2 or 3 weights.

6.6.14.2.7 All balances must be calibrated annually by a professional balance service. Certificates of calibration must be maintained at the marijuana testing facility.

6.6.14.2.8 All incubators, refrigerators, ovens, autoclave or sterilizers, and water baths must contain calibrated thermometers. The marijuana testing facility must maintain copies of the certificates of calibration for each thermometer. Thermometer range and graduation increments must be appropriate for the application for which it is used. Glass thermometers must be checked for accuracy annually, and other types of thermometers quarterly, by comparing with a NIST traceable thermometer at the temperatures of interest. Thermometers must be tagged with the initials of person who conducted the check, the date of accuracy check, and the correction factor (may be zero). There may be no separation in the liquid column of glass thermometers. Calibrated thermometers may be substituted for automated temperature recording systems. If this substitution is made, the marijuana testing facility must maintain copies of the certificates of calibration for the equipment. The automated temperature recording system must be checked for accuracy annually.

6.6.14.2.9 Use analytical reagent grade chemicals unless otherwise allowed or specified by the analytical method.

6.6.14.2.10 Date bottles of dehydrated microbiology media when received and opened. Marijuana testing facilities may not use media beyond the manufacturer's expiration date or beyond 1 year from opening, whichever is sooner. Media must be discarded immediately if caked or otherwise deteriorated. Prepared or prepackaged media are permitted.

6.6.14.2.11 Use plastic lab-ware for microbiology that is clear and non-toxic.

6.6.14.2.12 Reagent water for chemical analyses and for general use must be distilled or deionized and have a resistivity value greater than 0.5 megaohms/cm or a conductivity value of less than 2 microhmos/cm at 25° C. Quality checks shall be made according to specified analytical method requirements, but at least monthly, with a conductivity meter. All quality checks must be recorded.

6.6.14.2.13 For microbiological analyses, reagent water must meet all the following criteria:

PARAMETER	LIMITS	FREQUENCY
Resistivity	>0.5 megaohms/cm	Monthly
Pb, Cd, Cr, Cu, Ni, Zn	<0.05 mg/L per contaminant, and <0.1 mg/L total	Annually
Total chlorine residual	Non-detectable	Monthly
Heterotrophic plate count	<500 CFU/mL	Monthly
Bacteriological quality of reagent water	Ratio of growth rate: 0.8 to 3.0 (See Standard Methods, Section 9020B. This test is not required if marijuana testing facilities use water that meets the criteria for Types I and II water as defined in Standard Methods Section 1080).	Annually

6.6.14.2.14 Label all reagents and solutions to indicate identity, concentration, storage requirements, expiration dates and any other pertinent information.

6.6.14.2.15 Date all reagents and solutions when received and opened. Marijuana testing facilities may not use materials beyond their expiration dates.

6.6.14.2.16 All marijuana testing facility prepared reagents and solutions must be labeled with preparation and expiration dates. No laboratory prepared materials may be used beyond their expiration dates.

6.6.14.3 Safety and security. Marijuana testing facilities must:

6.6.14.3.1 Include safety instructions in a laboratory safety manual for the protection of personnel from physical, chemical, and biological hazards. The laboratory safety manual must include applicable programs for the protection of employees as outlined in the Code of Federal Regulations (29 C.F.R. Part 1910), including the Occupational Safety and Health Administration standards for hazard communication, and occupational exposure to hazardous chemicals in laboratories;

6.6.14.3.2 Keep samples, standards, reagents, solvents, acids, chemicals, and data in restricted access areas;

6.6.14.3.3 Implement the general security requirements required in subsection 6.3 of this regulation.

6.7 Marijuana cultivation facility general requirements

6.7.1 Marijuana cultivation facilities are permitted to:

6.7.1.1 Plant and cultivate marijuana plants, subject to the limits associated with each tier of license;

6.7.1.2 Harvest, trim, dry, and cure marijuana plants;

6.7.1.3 Store harvested marijuana, including kief and marijuana trim;

6.7.1.4 Sell and distribute marijuana, including kief and marijuana trim to marijuana cultivation facilities, marijuana product manufacturing facilities, and retail marijuana stores;

6.7.1.5 Provide samples of marijuana and marijuana products to the Division for mandatory compliance testing in accordance with Section 11.0 of this regulation at the direction of the Commissioner;

6.7.1.6 Collect samples of marijuana and marijuana products for research and development testing and transport those samples to a marijuana testing facility;

6.7.1.7 Prepare, package, and label marijuana into individual retail units for wholesale to a retail marijuana store;

6.7.1.8 Transport marijuana to marijuana products manufacturing facilities and retail marijuana stores; and

6.7.1.9 Destroy marijuana plants and marijuana in accordance with Section 12.0 of this regulation.

6.7.2 Marijuana cultivation facilities may not:

6.7.2.1 Produce marijuana concentrates, tinctures, extracts, or other marijuana products;

6.7.2.2 Sell marijuana or marijuana products directly to consumers; and

6.7.2.3 Permit marijuana or marijuana products to be consumed on the premises of the marijuana cultivation facility.

6.7.3 Standard operating procedures. A marijuana cultivation facility must establish standard operating procedures in accordance with subsection 6.4.2 of this regulation for all aspects of the planting, cultivating, harvesting, trimming, drying, curing, storing, selling, distributing, sampling, preparing, packaging, labeling, transporting, tracking, and destroying of marijuana plants. The standard operating procedures must include:

6.7.3.1 The creation and timely entry of accurate data into an inventory control system that identifies and tracks the marijuana cultivation facility's inventory of marijuana from the seed or immature plant to the time they are sold or transferred to another marijuana establishment;

6.7.3.2 The safe and sanitary storage of marijuana and marijuana products, including maintaining the cleanliness of any building or equipment used to store or display marijuana or marijuana products;

6.7.3.3 The procedure for providing a sample of its marijuana to the Division for testing and research purposes as required by Section 11.0 of this regulation;

6.7.3.4 The creation and maintenance of a record of samples provided to the Division for the purposes of mandatory compliance testing, the identity of the marijuana testing facility that tested the samples, and the results of the mandatory compliance testing;

6.7.3.5 The proper packaging and labeling of marijuana to be sold to retail marijuana stores, as required by Section 9.0 of this regulation;

6.7.3.6 The selling or transferring of marijuana, including seeds, immature plants, mature plants, and packaged and labeled marijuana, to retail marijuana stores, marijuana product manufacturing facilities, and other marijuana cultivation facilities;

6.7.3.7 The proper disposal and segregated storage of marijuana that is outdated, damaged, deteriorated, misbranded, or adulterated;

6.7.3.8 The training of all personnel in the standard operating procedures and retention of attendance records; and

6.7.3.9 A copy of the standard operating procedures must be readily available on-site for inspection by the Commissioner.

6.7.4 A marijuana cultivation facility must have an environmental and sustainability plan that includes efforts the facility will take to minimize the environmental impact of its operations and plans to minimize water usage.

6.7.5 Batch size. Marijuana cultivation facilities may not package marijuana in batches larger than 10 pounds.

6.7.6 Marijuana cultivation facility security requirements

6.7.6.1 Marijuana cultivation facilities must comply with the following facility protocols:

6.7.6.1.1 Ensure all activities related to the cultivation of marijuana plants take place within a fully enclosed secure indoor facility or within a secured fenced area;

6.7.6.1.2 Have sufficient gas, suction, electrical outlets, sinks, hot and cold running water, and bathroom facilities;

6.7.6.1.3 Have adequate temperature and humidity controls;

6.7.6.1.4 Prominently display a list of all trained personnel inside or immediately outside of the extraction area; and

6.7.6.1.5 Process only marijuana that has been harvested in areas designated for processing.

6.7.6.2 Marijuana cultivation facilities must comply with the following safety and security protocols:

6.7.6.2.1 Update their safety, security, and prevention and diversion plan upon requesting a 1-tier increase in size each renewal period; and

6.7.6.2.2 Implement the general security requirements required in subsection 6.3 of this regulation.

6.8 Marijuana product manufacturing facility general requirements

6.8.1 Standard operating procedures. A marijuana product manufacturing facility must establish standard operating procedures in accordance with subsection 6.4.2 of this regulation for all aspects of the receipt, processing, storage, packaging, labeling, handling, tracking, and shipping of products containing marijuana and marijuana waste. The standard operating procedures must be readily available for on-site inspection by the Commissioner and include:

6.8.1.1 The creation and timely entry of accurate data into an inventory control system that identifies and tracks the marijuana product manufacturing facility's stock of marijuana and marijuana products from the time they are delivered or produced to the time they are delivered to another marijuana establishment;

6.8.1.2 The creation and maintenance of a record of samples provided to a licensed marijuana testing facility, the identity of the marijuana testing facility, and the results of the mandatory compliance testing;

6.8.1.3 The sanitary storage of marijuana and marijuana products, including maintaining the cleanliness of any building or equipment used to store or display marijuana or marijuana products; and

6.8.1.4 The training of all personnel in the standard operating procedures and retention of attendance records.

6.8.2 A marijuana product manufacturing facility must have a standard operating procedure to:

6.8.2.1 Maintain the marijuana and marijuana products free from contamination;

6.8.2.2 Meet the sanitary standards for food preparation as described in 4 Del.C. § 1335(f).

6.8.2.3 Report any personal health condition that might compromise the cleanliness or quality of the marijuana or marijuana products.

6.8.3 A marijuana product manufacturing facility's standard operating procedure must provide for disposal and segregated storage of any marijuana or marijuana product:

6.8.3.1 That is outdated, damaged, deteriorated, misbranded, or adulterated; or

6.8.3.2 Whose containers or packages have been improperly or accidentally opened.

6.8.4 Equipment sanitation, accuracy, and maintenance logs. A marijuana product manufacturing facility's standard operating procedure must provide for maintaining the sanitation of equipment that comes in contact with marijuana or marijuana products. The marijuana product manufacturing facility must ensure that:

6.8.4.1 Automatic, mechanical, or electronic equipment is routinely calibrated and periodically checked to ensure proper performance; and

6.8.4.2 Any scale, balance, or other measurement device is routinely calibrated and periodically checked to ensure accuracy.

6.8.5 The marijuana product manufacturing facility must maintain an accurate log recording the cleaning and calibration of equipment. Weighing or measuring devices must be certified and calibrated in accordance with applicable requirements of the Delaware Department of Agriculture.

6.8.6 A marijuana product manufacturing facility may acquire hemp from a person licensed to produce hemp by the Delaware Department of Agriculture or the Secretary of the U.S. Department of Agriculture. Any product derived from hemp must comply with the testing requirements established in Section 11.0 of this regulation prior to distribution to a retail marijuana store.

6.8.7 A marijuana product manufacturing facility may not:

6.8.7.1 Add any marijuana to a food product where the manufacturer of the food product holds a trademark to the food product's name; except that a manufacturer may use a trademarked food product if the manufacturer uses the product as a component or as part of a recipe and where the marijuana product manufacturer does not state or advertise to the consumer that the final retail marijuana product contains a trademarked food product;

6.8.7.2 Intentionally or knowingly label or package a retail marijuana product in a manner that would cause a reasonable consumer confusion as to whether the retail marijuana product was a trademarked food product; or

6.8.7.3 Label or package a product in a manner that violates any federal trademark law or regulation.

6.8.8 Retail marijuana products must be prepared in a marijuana product manufacturing facility that is used exclusively for the manufacture and preparation of retail marijuana or retail marijuana products and using equipment that is used exclusively for the manufacture and preparation of retail marijuana products. Marijuana establishments must obtain approval of the Commissioner to co-locate multiple marijuana establishment license types on a single premises. The Commissioner may approve such application if the following conditions are met:

6.8.8.1 The co-located facilities are clearly delineated from each other in all plans;

6.8.8.2 Any shared space complies with all regulations applicable to each of the co-located license types;

6.8.8.3 The co-located facilities are physically separated by a permanent physical barrier or wall; and

6.8.8.4 The co-located facilities are connected by a single, lockable door.

6.8.9 Marijuana or marijuana products may not be consumed on the premises of a marijuana product manufacturing facility.

6.8.10 Permissible extractions. Except as provided in subsection 6.8.11 of this regulation, marijuana extraction shall only be conducted using the following methods:

6.8.10.1 Mechanical extraction, such as dry screens, sieves, or presses, potable water and ice made from potable water, cryogenic or subzero manufacturing not involving a solvent, or pressure and temperature.

6.8.10.2 Chemical extraction using a nonvolatile solvent such as a non-hydrocarbon-based or other solvent such as water, vegetable glycerin, vegetable oils, animal fats, or food-grade glycerin, (non-hydrocarbon-based solvents shall be food grade).

6.8.10.3 Chemical extraction using a division approved closed loop extraction system.

6.8.11 To request authorization from the Commissioner to conduct marijuana extraction using a method other than those specified in subsection 6.8.10 of this regulation, the marijuana establishment must submit a detailed description of the extraction method, including any documentation that validates the method and any safety procedures to be utilized to mitigate any risk to public or worker health and safety.

6.8.12 Extraction equipment shall be used and operated in accordance with its intended manufacturer use and design.

6.8.13 Current safety data sheets shall be kept on the premises for all chemicals used in the extraction process.

6.8.14 Any form of alkane or petroleum hydrocarbon extraction is unauthorized in Delaware.

6.8.15 Volatile solvent extractions. Chemical extractions using volatile solvents are subject to the following minimum requirements:

6.8.15.1 Hydrocarbon-based solvents must be at least 99.5% purity with a Certificate of Analysis from the manufacturer to confirm purity.

6.8.15.2 Ethyl alcohol must be food grade, and non-denatured in composition.

6.8.15.3 Solvents must be free of odorants, bitterants, or other additives and stored, handled, and disposed of in accordance with local, state, and federal regulations.

6.8.15.4 All extractions may be performed in a closed loop extraction system, unless approved by the Commissioner in accordance with subsection 6.8.11 of this regulation.

6.8.15.5 Marijuana product manufacturing facilities may not use ignition sources including heat guns or any open flame source next to extraction equipment that utilizes volatile solvents, including in rooms designated solely for extraction or in areas that contain or uses flammable liquids and gasses.

6.8.16 Closed-loop extraction system requirements. Closed loop systems, other equipment used, the extraction operation, and facilities must be approved for use by the local fire code official and meet any required fire, safety, and building code requirements specified in:

6.8.16.1 National Fire Protection Association (NFPA) standards;

6.8.16.2 International Building Code (IBC);

6.8.16.3 International Fire Code (IFC); and

6.8.16.4 Other applicable standards including all applicable fire, safety, and building codes related to the processing, handling and storage of the applicable solvent or gas.

6.8.17 The Commissioner must be notified when significant changes are made to the standard analytical procedure such as changes to extraction technique, or the instrumentation used.

6.8.18 Marijuana product manufacturing facility security requirements

6.8.18.1 Facility requirements. Each marijuana product manufacturing facility must adhere to the following:

6.8.18.1.1 Be housed in well-lighted, sanitary, vented quarters equipped with hot and cold running water and bathroom facilities, and contain ample space to process and examine the samples commensurate with the total workload;

6.8.18.1.2 Be in distinct and separate locations from living quarters unless provisions exist for separate entrances, and plumbing fixtures;

6.8.18.1.3 Have ample workbench space, have sufficient water, gas, suction, electrical outlets, and sinks;

6.8.18.1.4 Have adequate and proper storage space for all chemicals including explosive, flammable, corrosive, and caustic materials;

6.8.18.1.5 Have flooring composed of non-porous material in laboratory areas where acids, caustics, and solvents are used;

6.8.18.1.6 Have adequate temperature and humidity controls as may be required for proper operation of instruments affected by environmental conditions;

6.8.18.1.7 Prominently display a list of all trained personnel inside or immediately outside of the extraction area: and

6.8.18.1.8 Have adequate electrical supply.

6.8.18.2 Safety and security. Marijuana product manufacturing facilities must:

6.8.18.2.1 Establish and maintain adequate safety and security precautions;

6.8.18.2.2 Include safety instructions for the protection of personnel from physical, chemical, and biological hazards;

6.8.18.2.3 Provide each member of management and personnel a safety orientation and annually review policies and procedures in the safety manual including the proper use of security measures and procedures that have been adopted specific to responding to an emergency, including robbery, violence, or accident;

6.8.18.2.4 Keep samples, standards, reagents, solvents, acids, chemicals, and data in restricted access areas;

6.8.18.2.5 Supervise visitors, repair worker, and maintenance workers in restricted areas; and

6.8.18.2.6 Implement the minimum-security requirements required in subsection 6.3 of this regulation.

6.9 Marijuana micro-businesses are required to adhere the requirements in 4 Del.C. §§ 1340 and 1343 and this regulation.

4 Del. Admin. Code § 5001-6.0

28 DE Reg. 226 (9/1/2024) (Final)