16 Del. Admin. Code § 4470-8.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4470-8.0 - Registration and Operation of Safety Compliance Facilities

8.1 General Requirements for Operation of a Safety Compliance Facility

8.1.1 A Safety Compliance Facility may only operate if they have been issued a valid registration certificate from the Department.

8.1.2 A Safety Compliance Facility must be operated in accordance with the International Organization for Standardization 17025 (ISO 17025) standards as confirmed by accreditation by a third-party accrediting body or a qualified auditing organization using ISO 17025 criteria approved by the Department.

8.2 Security Requirements

8.2.1 A Safety Compliance Facility shall implement appropriate security and safety measures to deter and prevent the unauthorized entrance into areas containing marijuana and the theft of marijuana. Such measures shall include the following:

8.2.1.1 Exterior of premises

8.2.1.1.1 With respect to the exterior of a Safety Compliance Facility:

8.2.1.1.1.1 Access from outside the premises shall be kept to a minimum and be well controlled;

8.2.1.1.1.2 The outside perimeter of the premises shall be well lit; and

8.2.1.1.1.3 Entry into any area where marijuana is held shall be limited to authorized personnel.

8.2.1.2 Alarm system

8.2.1.2.1 A Safety Compliance Facility shall have a fully operational security alarm system that will provide suitable protection against theft and diversion. For the purpose of these regulations, a fully operational security alarm system shall include:

8.2.1.2.1.1 Immediate automatic or electronic notification to alert local or municipal law enforcement agencies of an unauthorized breach of security at the Safety Compliance Facility or at any other authorized physical address;

8.2.1.2.1.2 Immediate automatic or electronic notification to local or municipal public safety personnel of a loss of electrical support backup system; and

8.2.1.2.1.3 When appropriate, the security system shall provide protection against tampering with computers or electronic records done to conceal theft or diversion.

8.2.1.2.2 A Safety Compliance Facility shall conduct a maintenance inspection/test of the alarm system for each authorized location at intervals not to exceed 30 days from the previous inspection/test. A Safety Compliance Facility shall promptly make all necessary repairs to ensure the proper operation of the alarm system.

8.2.1.2.3 In the event of a failure of the security system, due to loss of electrical support or mechanical malfunction, that is expected to exceed an eight-hour period, a Safety Compliance Facility shall:

8.2.1.2.3.1 Within 24 hours of discovery of the event, notify the Department by telephone; and

8.2.1.2.3.2 Provide alternative security measures approved by the Department or close the authorized physical addresses affected by the failure/malfunction until the security alarm system has been restored to full operation.

8.2.1.2.4 A Safety Compliance Facility shall maintain documentation in an auditable form for a period of at least 24 months after the event for:

8.2.1.2.4.1 All maintenance inspections/tests conducted in response to subsection 8.2.1.2.4 of these regulations, and any servicing, modification or upgrade performed on the security alarm system. The record shall include, at a minimum, the date of the action, a summary of the actions performed and the name, signature and title of the individual who performed the actions.

8.2.1.2.4.2 Any alarm activation or other event which requires response by public safety personnel; and

8.2.1.2.4.3 Any unauthorized breach of security.

8.2.1.3 Video surveillance

8.2.1.3.1 A Safety Compliance Facility shall provide an appropriate video surveillance system that includes the following areas and access to recorded surveillance.

8.2.1.3.1.1 Video surveillance should record access areas and anywhere the marijuana is handled;

8.2.1.3.1.2 Video footage will be digitally recorded and held for an appropriate time period consistent with the Division of Public Health's Records Retention Policy; and

8.2.1.3.1.3 A Safety Compliance Facility shall provide the Department with access to the video 24-hours a day, seven days a week through a secure internet connection.

8.2.1.4 Inventory controls

8.2.1.4.1 Coding and computer interface

8.2.1.4.1.1 A Safety Compliance Facility shall employ a barcoding inventory control system to track the source, strain, batch and weight of marijuana sample in inventory.

8.2.1.4.2 Storage of marijuana

8.2.1.4.2.1 A Safety Compliance Facility shall ensure that marijuana is stored in a locked area with adequate security. For purpose of these regulations "adequate security," at a minimum, should be assessed, established and maintained based on:

8.2.1.4.2.1.1 The quantity of marijuana present;

8.2.1.4.2.1.2 The geographic location of the Safety Compliance Facility (i.e.: high-crime or low-crime area); and

8.2.1.4.2.1.3 The scope and sustainability of the alarm system.

8.3 Operations Manual

8.3.1 A Safety Compliance Facility shall, as part of its initial application, provide to the Department a true, correct and current copy of its operations manual, and shall maintain such operations manual in accordance with the Act and these regulations. Such manual shall include, at a minimum, the following requirements:

8.3.1.1 Procedures for the oversight of the Safety Compliance Facility including, but not limited to, documentation of the reporting and management structure of the Safety Compliance Facility;

8.3.1.2 Procedures to ensure accurate record keeping;

8.3.1.3 Employee security policies;

8.3.1.4 Safety and security procedures, including a disaster plan with procedures to be followed in case of fire or other emergencies;

8.3.1.5 Crime prevention techniques;

8.3.1.6 A job description or employment contract developed for all employees which includes duties, responsibilities, authority, qualification and supervision;

8.3.1.7 The Safety Compliance Facility's alcohol and drug free workplace policy;

8.3.1.8 A description of the documentation that will accompany a registered Safety Compliance Facility agent when transporting marijuana on behalf of the registered Safety Compliance Facility. As required by 16 Del.C. § 4918A(b), the documentation must specify, at least, the amount of marijuana being transported, the date the marijuana is being transported, the registry identification number of the registered Safety Compliance Facility, and a contact number to verify that the marijuana is being transported on behalf of the registered Safety Compliance Facility;

8.3.1.9 Detailed procedures regarding the testing of medical marijuana. As part of its initial application, a Safety Compliance Facility shall provide to the Department detailed procedures regarding the testing of medical marijuana, and shall adhere to such procedures in connection with the operation of the Safety Compliance Facility;

8.3.1.9.1 Each batch of medical marijuana harvested by a compassion center shall be tested in accordance with this regulation.

8.3.1.10 Such procedures shall include a description of how the marijuana will be tested including:

8.3.1.10.1 What tests are conducted;

8.3.1.10.2 What testing procedures are used;

8.3.1.10.3 How results are loaded into DEC3S;

8.3.1.10.4 How disposal of samples is tracked;

8.3.1.10.5 The selection process; and

8.3.1.10.6 The number of samples tested.

8.3.1.11 What equipment will be used to test and report on including:

8.3.1.11.1 Potency and cannabinoid profile;

8.3.1.11.2 Contaminates including mold, mildew and organic material;

8.3.1.11.3 Plant growth regulators;

8.3.1.11.4 Pesticides;

8.3.1.11.5 Microbiological contaminants and mycotoxins; and

8.3.1.11.6 Residual solvents.

8.3.1.12 What levels or combination of contaminants mandate elimination of a batch.

8.4 Required Training

8.4.1 Each Safety Compliance Facility shall develop, implement and maintain on the premises an on-site training curriculum, or enter into contractual relationships with outside resources capable of meeting employee and agent training needs. Each employee or agent at the time of initial appointment, shall receive, as a minimum, training in the following:

8.4.1.1 Professional conduct, ethics, and state and federal laws;

8.4.1.2 The proper use of security measures and controls that have been adopted; and

8.4.1.3 Specific procedural instructions for responding to an emergency, including robbery or an accident resulting in injury, fire or damage to critical equipment.

8.5 Personnel Records

8.5.1 Each Safety Compliance Facility shall maintain a personnel record for each employee or agent for a period of at least six months after termination of the individual's affiliation with the Safety Compliance Facility. The record shall include, as a minimum, the following:

8.5.1.1 An application for employment or to volunteer;

8.5.1.2 A record of any disciplinary action taken;

8.5.1.3 Documentation of all required training. Documentation shall include a signed statement from the individual indicating the date, time and place of said training and topics discussed, including the name and title of presenters.

8.6 Application for Operation of a Safety Compliance Facility

8.6.1 A Safety Compliance Facility may only operate if they have been issued a valid registration certificate from the Department. When applying for a Safety Compliance Facility registration certificate, the applicant shall submit the following in accordance with these regulations:

8.6.1.1 The proposed legal name of the Safety Compliance Facility;

8.6.1.2 The proposed physical address of the Safety Compliance Facility;

8.6.1.3 The name, address, and date of birth of each principal officer and board member of the Safety Compliance Facility, provided that all such individuals shall be at least 21 years of age; and

8.6.1.4 Any information required by the Department to evaluate the applicant pursuant to the competitive bidding process.

8.7 Safety Compliance Facility Application Review Criteria

8.7.1 The Department shall evaluate applications for Safety Compliance Facility registration certificates using an impartial and numerically scored process developed by the Department in accordance with this chapter. The registration considerations shall consist of the following criteria:

8.7.1.1 The proposed principal officers' and board members' relevant experience, including any training or professional licensing related to analytical testing, medicine, pharmaceuticals, natural treatments, botany, or marijuana cultivation, preparation, and testing and their experience running businesses or not-for-profits;

8.7.1.2 The suitability of the proposed location, including compliance with any local zoning laws and the geographic convenience to compassion centers throughout the state of Delaware;

8.7.1.3 The sufficiency of the applicant's plans for safety, security, and the prevention of diversion, including proposed locations and security devices employed; and

8.7.1.4 The proposed Safety Compliance Facility's plan for operations and services, including its staffing and training plans, and whether it has sufficient capital to operate.

8.8 Issuance of Registration Certificate Authorizing Operation of a Safety Compliance Facility

8.8.1 An application for a Safety Compliance Facility registration certificate must be denied if any of the following conditions are met:

8.8.1.1 Applicant failed to submit the materials required by this subsection, including if the plans do not satisfy the security, oversight, or recordkeeping regulations issued by the Department;

8.8.1.2 Applicant would not be in compliance with local zoning regulations issued in accordance with 16 Del.C. § 4917A; or

8.8.1.3 Applicant does not meet the requirements of 16 Del.C. § 4919A.

8.8.2 After a Safety Compliance Facility is approved, but before it begins operations, it shall submit a registration fee paid to the Department in the amount of $40,000 and, if a physical address had not been finalized when it applied, its physical address.

8.8.3 The Department shall issue a renewable registration certificate with an identification number after a satisfactory compliance inspection by the Department.

8.9 Registry Identification Cards for Principal Officers, Board Members, Agents, Volunteers or Employees of a Safety Compliance Facility

8.9.1 An application for a registry identification cards must be denied if any of the following conditions are met:

8.9.1.1 If the prospective principal officer or board members has been convicted of an excluded felony offense;

8.9.1.2 If the prospective principal officer or board members has served as a principal officer or board member for a registered Safety Compliance Facility or registered compassion center that has had its registration certificate revoked; or

8.9.1.3 If the principal officer or board members is younger than 21 years of age.

8.9.2 A record of the source of any funds that will be used to open or maintain the Safety Compliance Facility, including the name, address, and date of birth of any investor contributing more than $5,000.

8.9.3 A record of any instances in which a business or not-for-profit that any of the prospective board members managed or served on the board of was convicted, fined, censured, or had a registration or license suspended or revoked in any administrative or judicial proceeding.

8.10 Expiration Date

8.10.1 A Safety Compliance Facility registration shall expire two years after its registration certificate is issued. The Safety Compliance Facility may submit a renewal application at any time beginning 90 days prior to the expiration of its registration certificate. Such renewal application must be submitted a minimum of 30 days prior to the expiration of its registration certificate to avoid suspension of the certificate.

8.11 Expiration, Termination or Renewal of a Registration Certificate Authorizing Operation of a Safety Compliance Facility

8.11.1 Registration certificates may be renewed every two years. The registered Safety Compliance Facility may submit a renewal application beginning 90 days prior to the expiration of its registration certificate. The Department shall grant a renewal application within 30 days of its submission if the following conditions are all satisfied:

8.11.1.1 The registered Safety Compliance Facility submits a renewal application and the required $40,000 renewal fee, which shall be refunded if the renewal application is rejected;

8.11.1.2 The Department has not suspended the registered Safety Compliance Facility's registration certificate for violations of this chapter or regulations adopted pursuant to this chapter;

8.11.1.3 The inspections authorized by 16 Del.C. § 4919A(u) do not raise serious concerns about the continued operation of the registered Safety Compliance Facility applying for renewal;

8.11.1.4 The Annual Report provided pursuant to 16 Del.C. § 4922A, confirms a continued need for the facility;

8.11.1.5 The applicant continues to meet all of the requirements for the operation of a Safety Compliance Facility as set forth in the Act and in these regulations; and

8.11.2 Suspension

8.11.2.1 The Department may suspend a registration certificate authorizing the operation of a Safety Compliance Facility for any violation of an applicable law or regulation.

8.11.3 Termination

8.11.3.1 Upon receipt of written notice that a registration certificate has been terminated, the Safety Compliance Facility has 30 business days to request, in writing, a hearing, for the purpose of review of such action. The hearing process shall follow the procedures in subsections 9.4 through 9.5.10 of these regulations:

8.11.3.1.1 A written decision will be issued by the Department within 30 days of the completion of the hearing. The decision will lift the suspension or terminate a registration certificate. The written decision will state with specificity the reasons for the decision; and

8.11.3.1.2 The termination of a registration certificate is a final decision of the Department, subject to judicial review. Jurisdiction and venue are vested in the Superior Court.

8.12 Non-transferable Registration Certificate Authorizing Operation of a Safety Compliance Facility

8.12.1 A registration certificate authorizing operation of a Safety Compliance Facility shall not be transferred by assignment or otherwise to other persons or locations. Unless the Safety Compliance Facility applies for and receives an amended registration certificate authorizing operation of a Safety Compliance Facility, the registration certificate shall be void and returned to the Department upon one or more of the following occurrences:

8.12.1.1 A change in ownership of the Safety Compliance Facility;

8.12.1.2 A change authorized physical location; or

8.12.1.3 The Safety Compliance Facility discontinues its operation.

8.12.2 A Safety Compliance Facility shall provide the Department with a written notice of any change described in subsection 8.12.1 of these regulations at least 60 days prior to the proposed effective date of the change. The Department may waive all or part of the required advance notice to address emergent or emergency situations.

8.12.3 Transactions which usually do not constitute a change of ownership include the following:

8.12.3.1 Changes in the membership of the board of directors or board of trustees; or

8.12.3.2 Two or more legal entities merge and the entity to whom the registration certificate authorizing operation of a Safety Compliance Facility was issued survives.

8.12.3.3 Management agreements are generally not considered a change in ownership if the entity to whom the registration certificate authorizing operation of a Safety Compliance Facility was issued continues to retain ultimate authority for the operation of the Safety Compliance Facility. However, if the ultimate authority is surrendered and transferred from the entity to whom the registration certificate authorizing operation of a Safety Compliance Facility was issued to a new manager, then a change of ownership has occurred.

8.13 Inspection

8.13.1 The Safety Compliance Facility will be available to State regulators for inspections, both scheduled and unscheduled, during normal business hours.

16 Del. Admin. Code § 4470-8.0

17 DE Reg. 738(1/1/2014)
23 DE Reg. 667(2/1/2020)
24 DE Reg. 485( 11/1/2020) (Final)