Delaware Administrative Code
Title 4 - Alcoholic Beverage Control
Department of Safety and Homeland Security
Office of the Marijuana Commissioner
5000
5001 - Rules of the Office of the Marijuana Commissioner
Section 5001-6.0 - General Compliance

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.

6.3.2.2.1 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.

6.3.2.4.1 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:

6.3.2.4.3 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.

6.3.2.5.1 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:

6.4.4.3.1 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.

6.4.4.4.1 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.

6.5.3.6.1 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.

6.5.5.2.1 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.

6.5.7.1.1 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.

6.5.7.2.1 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.

6.6.6.2.1 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.

6.6.6.4.1 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.

6.6.7.3.1 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.

6.6.7.4.1 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.

6.6.9.1.1 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.

6.6.10.4.1 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:

6.6.10.4.2 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.

6.6.14.1.1 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.

6.6.14.2.1 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:

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.

6.6.14.3.1 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.

6.7.6.1.1 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.

6.7.6.2.1 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.

6.8.18.1.1 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.

6.8.18.2.1 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.