16 Del. Admin. Code § 4470-12.0

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

Section 4470-12.0 - Marijuana Infused Food Establishment Endorsement Requirements

12.1 Conditions of the Marijuana Infused Food Establishment Endorsement

12.1.1 Upon acceptance of the endorsement to operate a Marijuana Infused Food Establishment issued by the Division the Compassion Center shall:

12.1.1.1 Allow representatives of the Division access to the Marijuana Infused Food Establishment during hours of operation and other reasonable times. After the Division representative presents official credentials and an intent to conduct an inspection the producer shall allow the Division representative to determine if the Marijuana Infused Food Establishment is in compliance with these regulations by allowing access to the establishment, allowing inspection, and providing information and records to which the Division is entitled according to law;

12.1.1.2 Comply with Division directives including time frames for corrective actions specified in inspection reports and other directives issued by the Division regarding the Marijuana Infused Food Establishment. Comply with the conditions of a granted variance, and conditions of approved facility plans and specifications;

12.1.1.3 Accept notices issued and served by the Division according to the law. Be subject to the administrative, civil, injunctive, and criminal remedies authorized in law for failure to comply with the regulations or Division directives, including time frames for corrective actions specified in inspection reports;

12.1.1.4 Immediately discontinue operations and notify the Division if an imminent health hazard may exist because of 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 foodborne illness outbreak, gross unsanitary occurrence or condition, or other circumstance that may endanger health;

12.1.1.5 Immediately contact the Division to report an illness of an employee who is diagnosed with Norovirus, Salmonella typhi (Typhoid fever), Shigella spp., Shiga toxin-producing E. Coli including 0157:H7, Hepatitis A virus or nontyphoidal salmonella;

12.1.1.6 Replace existing facilities and equipment with facilities and equipment that comply with the Code if:

12.1.1.6.1 The Division directs the replacement because the surfaces and equipment constitute a public health hazard or nuisance or no longer comply with the criteria upon which the surfaces and equipment were accepted; or

12.1.1.6.2 The Division directs the replacement of the facilities and equipment because of a change of ownership.

12.1.1.7 Prepare and maintain a current written contingency plan for use in initiating and affecting a product recall.

12.2 Safe Production of Marijuana Infused Products

12.2.1 Each facility for the production of edible marijuana products or marijuana-infused products shall ensure that:

12.2.1.1 Pasteurized eggs or egg products are substituted for raw eggs in the preparation of edible marijuana products or marijuana-infused products.

12.2.1.2 Marijuana products and ingredients only have contact with the surfaces of:

12.2.1.2.1 Equipment and utensils that are cleaned and sanitized; or

12.2.1.2.2 Single-service and single-use articles that have not previously been used.

12.2.1.3 All ingredients must be cooked thoroughly to a safe temperature for the proper time.

12.3 Quality Control Unit

12.3.1 Each facility for the production of edible marijuana products or marijuana-infused products shall have a quality control unit that:

12.3.1.1 Has the responsibility and authority to approve or reject all components, product containers, closures, in-process materials, packaging materials, labeling and marijuana or marijuana products;

12.3.1.2 Has the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated and resolved;

12.3.1.3 Is responsible for approving or rejecting marijuana or marijuana products manufactured, processed, packaged or held under contract by another Compassion Center;

12.3.1.4 Is responsible for approving or rejecting all procedures or specifications which may impact the identity, strength, quality and purity of the marijuana or marijuana products.

12.3.2 Each Compassion Center or Marijuana Infused Food Establishment shall:

12.3.2.1 Set forth the responsibilities and procedures applicable to the quality control unit in writing; and

12.3.2.2 Follow the written responsibilities and procedures set forth pursuant to subsection 7.3 .12.3.

16 Del. Admin. Code § 4470-12.0

23 DE Reg. 667( 2/1/2020) (final)