Source: http://regulations.delaware.gov/register/february2019/proposed/22%20DE%20Reg%20652%2002-01-19.htm
Timestamp: 2019-07-18 17:22:52
Document Index: 725513294

Matched Legal Cases: ['§534', '§4906', '§4918', '§4922', '§10128', '§10142', '§343', '§1700', '§107']

Pursuant to 16 Del.C. Ch. 49A, Office of Medical Marijuana (OMM), Division of Public Health, Department of Health and Social Services, is proposing revisions to the regulations governing the State of Delaware Medical Marijuana Code. On February 1, 2019, the Division of Public Health plans to publish as “proposed” revisions to the State of Delaware Medical Marijuana Code. The revisions include the establishment of requirements for Safety Compliance facilities, provisions for the production of edible medical marijuana products and limitations therein, compliance and enforcement procedures, random sampling procedures, and the addition of specific definitions and technical corrections.
Copies of the proposed regulations are available for review in the February 1, 2019 edition of the Delaware Register of Regulations, accessible online at: http://regulations.delaware.gov or by calling the Division of Public Health at (302) 744-4951.
Any person who wishes to make written suggestions, testimony, briefs or other written materials concerning the proposed regulations must submit them to Alanna Mozeik by Friday, March 8, 2019, at:
Email: Alanna.Mozeik@state.de.us
The Secretary of Delaware Health and Social Services adopts these Regulations regulations in response to the authority vested in the Secretary by 16 Del.C. Ch. 49A, The Delaware Medical Marijuana Act. These Regulations regulations establish the standards for the procedures for issuing a certificate of registration to qualified patients and primary caregivers. These Regulations regulations provide a system of permitting and inspection, as well as governing confidentiality, payments of fees, and enforcement of these rules.
"Background check" means any person required to obtain a background check under this chapter shall submit fingerprints and other necessary information to the State Bureau of Identification in order to obtain a report of the person's entire criminal history record from the State Bureau of Identification or a statement that the State Bureau of Identification Central Repository contains no such information relating to that person. The report will include the person's entire federal criminal history record from the Federal Bureau of Investigation pursuant to Federal Bureau of Investigation appropriation of Title II of Public Law 92-544 (28 U.S.C. §534) or a statement that the Federal Bureau of Investigation's records contain no such information relating to that person. A person required to obtain a background check under this chapter is responsible for any costs associated with obtaining the background check.
“Butane Hash Oil” or “(BHO)” means a cannabis concentrate produced using an alkane or petroleum hydrocarbon.
“Cannabidiol” or “CBD” is a cannabinoid found in cannabis with mild psychoactive properties which does not induce an euphoric high.
(a)	Terminal illness, cancer, positive status for human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), decompensated cirrhosis (hepatitis C), amyotrophic lateral sclerosis (ALS or Lou Gehrig’s Disease), post-traumatic stress disorder (PTSD), intractable epilepsy, autism with self-injurious or aggressive behavior, seizure disorder, glaucoma, debilitating migraines, and agitation of Alzheimer’s disease or the treatment of these conditions;
(c)	Pediatric qualifying conditions are limited to any of the following related to a terminal illness; pain; anxiety; depression; seizure disorder; severe debilitating autism; or a chronic or debilitating disease or medical condition where they have failed treatment involving one or more of the following symptoms: cachexia or wasting syndrome; intractable nausea; severe, painful and persistent muscle spasms.
(cd)	any Any other medical condition or its treatment added by the Department, as provided for in 16 Del.C. §4906A and Section 6.0 of this code.
“Delaware Enterprise Consolidated Cannabis Control System” is the state-wide application which serves as patient registry, point of sale monitor, seed to sale inventory tracker and repository of medical marijuana product test results, hereinafter known as DEC3S.
“Delaware Food Code” means the current State of Delaware Food Code.
“Drinking Water” means water that meets criteria as specified in 40 CFR 141 National Primary Drinking Water Regulations. "Drinking water" is traditionally known as "potable water." "Drinking water" includes the term "water" except where the term used connotes that the water is not potable, such as "boiler water," "mop water," "rainwater," "wastewater," and "nondrinking" water.
“Employee” or “Agent” refers to an individual having supervisory or management duties; an individual on the payroll; a volunteer; an individual performing work under contractual agreement; or any other individual working in a marijuana business.
“Food Equipment” means an article that is used in the operation of a marijuana infused food establishment such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, and table, temperature measuring device for ambient air, vending machine, or ware washing machine. Equipment may be defined as a food-contact surface or non-food contact surface. "Equipment" does not include apparatuses used for handling or storing large quantities of packaged foods that are received from a supplier in a cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets, racks, and skids.
“Imminent Health Hazard” means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on: the number of potential injuries, and the nature, severity, and duration of the anticipated injury.
“Poisonous and Toxic Materials” means substances that are not intended for ingestion, including cleaners and sanitizers, pesticides, necessary maintenance substances, such as non-food grade lubricants, and personal care items, such as medicines, first aid supplies, cosmetics and toiletries.
“Terminal Illness” means any disease, illness or condition sustained by a human being for which there is no reasonable medical expectation of recovery and as medical probability, will result in the death of such human being regardless of the use or discontinuance of medical treatment implemented for the purpose of sustaining life or the life process; and as a result of which, the human being’s health-care practitioner would not be surprised if death were to occur within 12 months.
3.3.3.1	The qualifying patient has intractable epilepsy pain, anxiety or depression related to terminal illness; or
3.3.3.2	The qualifying patient has intractable epilepsy or a seizure disorder; severe debilitating autism or;
3.3.3.23.3.3.3	The qualifying patient has a chronic or debilitating disease or medical condition where the patient has failed treatment involving 1 one or more of the following symptoms: cachexia or wasting syndrome; intractable nausea; seizures; severe, painful and persistent muscle spasms.
4.1	The Department shall issue a registry identification card to a primary caregiver applicant for the purpose of managing the well-being of one to five qualified patients, including themselves if caregiver is a qualified patient, in response to the requirements of this rule upon the completion and approval of the primary caregiver application form, available from the medical marijuana program, and a non-refundable application fee, in the form of a personal check or a cashier’s check made out to “Division of Public Health, Medical Marijuana Program”. “State of Delaware-MMP”. In order for a registry identification card to be obtained and processed, the following information shall be submitted to the medical marijuana program:
4.2.1.1	All designated caregiver applicants are required to consent to a nationwide and statewide criminal history screening background check every three years. All applicable application fees associated with the nationwide and statewide criminal history screening background check shall be paid by the primary caregiver applicant.
5.3.1.1	a A change in card holder's cardholder’s name or address,
5.3.1.2	knowledge Knowledge of a change that would render the patient no longer qualified to participate in the program, such as a cure of the debilitating condition causing the need for Medical Marijuana,
5.3.1.3	knowledge Knowledge of a change that renders the patient's physician no longer a qualified "physician" as defined in 2.0 of these regulations,
5.5	Registry identification card renewal application: Each registry identification card issued by the Department is valid in accordance to Section with subsection 5.2. A qualified patient or primary caregiver shall apply for a registry identification card renewal no less than 45 calendar days prior to the expiration date of the existing registry identification card in order to prevent interruption of possession of a valid (unexpired) registry identification card.
6.4.4.2	DPH will post notice of a public hearing no fewer than 10 days prior to the public hearing.
7.1.1.1.1	All employees of a compassion center must have an ID badge issued by the Office of Medical Marijuana. Anyone with access to marijuana or marijuana concentrates must have an ID badge issued by the Office of Medical Marijuana.
7.1.5.1	The medical marijuana inventory system must be updated immediately when a plant is pulled out of inventory for destruction, starting the 72 hour destruction quarantine. The plant number, date and reason must be recorded. This information must be available for auditing by the department.
7.2.8.3.1.1	shall Shall not dispense, deliver or otherwise transfer marijuana to a person other than a qualifying patient or to such patient’s other primary caregiver.
7.2.8.3.1.4.1	Any change in the oil formulation must be made by the Department based upon the recommendation of the Medical Marijuana Act Oversight Committee.
7.3.2	procedures Procedures for safely dispensing medical marijuana to registered qualifying patients or their registered primary caregiver;
7.3.9	a A description of the compassion center’s outreach activities to registered qualifying patients or their registered primary caregiver, which shall as a minimum include:
7.8.8.4	details Details indicating the levels of active ingredients in the product;
7.8.10	the The applicant’s ability to grow marijuana without use of pesticides.
7.10.2.1	The compassion center submits materials required under Section subsection 7.9 of these regulations, including a summary annual report with financial audit attached, and a comprehensive inventory with a cover letter and the $40,000 fee, which shall be refunded if the renewal application is rejected;
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. In response to 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;
8.88.7	Testing Facility Center Safety Compliance Facility Application Review Criteria. RESERVED
8.7.1	The Department shall evaluate applications for Safety Compliance Facility registration certificates using an impartial and numerically scored competitive bidding process developed by the Department in accordance with this chapter. The registration considerations shall consist of the following criteria:
8.8.1	The Department shall issue at least one Safety Compliance Facility registration certificate to the highest-scoring applicant. An application for a Safety Compliance Facility registration certificate must be denied if any of the following conditions are met:
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; and
8.11.1.1	The registered Safety Compliance Facility submits a renewal application and the required renewal fee, which shall be refunded if the renewal application is rejected;
8.11.1.4	The Annual Report provided pursuant to 16 Del.C. §4922A, confirms a continued need for the center;
8.11.1.6	Approval of the Division Director after review of all factors including performance and customer service reviews.
9.2.1	If violations of these requirements are cited as a result of monitoring or civil police contact, the qualified patient or primary caregiver shall be provided with an official written report of the findings within 30 days following the monitoring visit.
9.2.5.19.2.5.1.1	A qualified patient or primary caregiver whose registry identification card has been summarily suspended is entitled to may request a record review not later than 30 calendar days after the registry identification card was summarily suspended.
9.3.1.3.3	in In the workplace of the qualified patient's or primary caregiver's employment;
9.3.2.1	Violation of any provision of this rule may result in either the summary suspension of the qualified patient’s or primary caregiver’s registry identification card, or a notice of contemplated action to suspend or revoke the qualified patient’s or primary caregiver’s registry identification card, and all lawful privileges under the act.
9.4.1	A qualified patient or primary caregiver whose registry identification card has been summarily suspended, or who has received a notice of contemplated action to suspend or revoke, may request a hearing, in addition to a request for a record review, for the purpose of review of such action. The request for hearing shall be filed within 30 calendar days of the date the action is taken or the notice of contemplated action is received. The request shall include the following:
9.4.39.4.1.3	a A statement of the arguments that the qualified patient/primary caregiver considers relevant to the review of the action; and
9.5.3	A written copy of the determination and the reasons upon which it is based shall be sent to the patient or caregiver cardholder within 30 calendar days.
9.5.4	An individual may request an expedited hearing.
9.5.4.1	The Department shall schedule the hearing on an expedited basis provided that the Department receives the individual's written request for an expedited hearing within five (5) calendar days from the date on which the individual received notification of the Department's decision to summarily suspend the individual’s card.
9.5.4.2	The Department shall convene an expedited hearing within 15 calendar days of the receipt by the Department of such a request.
9.5.4.3	The Department shall make a determination based upon the evidence presented.
9.5.4.4	A written copy of the determination and the reasons upon which it is based shall be sent to the individual within 30 calendar days.
9.5.5	Telephonic hearings
9.5.5.1	An individual cardholder may request a telephonic hearing at the time of the request for a hearing. Immediately after the parties agree to conduct the hearing by telephone, notice of the telephonic hearing shall be made to all parties and shall include all necessary telephone numbers.
9.5.5.2	Any party that has agreed to a telephonic hearing, but subsequently requests an in-person hearing shall do so in writing to the hearing officer no later than 10 calendar days before the scheduled date of the hearing. The decision to grant or deny the request for an in-person hearing shall be at the discretion of the hearing officer for good cause shown. The hearing officer’s decision to grant or deny the hearing shall be issued in writing and shall include the specific reasons for granting or denying the request. Should the hearing officer grant the request, the hearing shall be rescheduled to a time convenient for all parties. Should the hearing officer deny the request, the telephonic hearing shall proceed as scheduled.
9.5.5.3	The location or locations of the parties during the hearing shall have a speaker telephone and technology available so that all shall hear the proceedings and documents shall be transmitted between witnesses and the hearing officer.
9.5.5.4	Failure to provide the correct telephone number or failure to be available at the commencement of the hearing shall be treated as a failure to appear and shall subject the petitioner to a default judgment.
9.5.5.5	The in-person presence of some parties or witnesses at the hearing does not prevent the participation of other parties or witnesses by telephone with prior approval of the hearing officer.
9.5.6	During an administrative hearing:
9.5.6.1	The individual has the right to be represented by counsel.
9.5.6.2	All statements made shall be under oath.
9.5.6.3	The individual has the right to examine and cross-examine witnesses.
9.5.7	A stenographic recording will be made by a qualified court reporter. At the request and expense of any party, such record shall be transcribed with a copy to the other party.
9.5.8	Following the hearing, the Department shall make a determination based upon the evidence presented.
9.5.9	Upon reaching its conclusion of law and determining an appropriate disciplinary action, the Department shall issue a written decision and order in accordance with §10128 of Title 29.
9.5.10	All decisions of the Department shall be final and conclusive. Where the individual is in disagreement with the action of the Department, the individual may appeal the Department's decision to the Superior Court within 30 days of service or of the postmarked date of the copy of the decision mailed to the individual. The appeal shall be on the record to the Superior Court and shall be as provided in §§10142 - 10145 of Title 29.
10.2.2	Are not presented in packaging that is appealing to children;
10.2.4	Are packaged and labeled in such a manner as to allow tracking by the statewide cannabis inventory control system called Delaware Enterprise Consolidated Cannabis Control System (DEC3S).
10.3	Exemptions
10.3.1	Establishments registered as marijuana infused food establishments in Delaware shall be exempt from the Cottage Food Regulations.
10.3.2	Establishments registered under these regulations shall be exempt from the Delaware Food Code.
10.4	Inspections
10.4.1	The Division may conduct one or more preoperational inspections to verify that the marijuana infused food establishment is:
10.4.1.1	Constructed and equipped in accordance with the registration application;
10.4.1.2	Has established standard operating procedures as specified; and
10.4.1.3	Is otherwise in substantial compliance with these regulations.
10.4.2	Additional inspections both scheduled and no-notice will be conducted at the discretion of the Division and as deemed necessary by the Division.
11.1.4	A Marijuana Infused Food Establishments shall only produce those specific food products listed on their registration.
11.2.2	Production of food in a Marijuana Infused Food Establishment is limited to foods that are non-TCS.
11.2.3	The manufacturing of baked goods shall be allowed in a Marijuana Infused Food Establishment. Items include, but are not limited to: cookies, muffins and brownies. Bakery items which as a finished product contain components such as fruit filling, cream filling or meat are not allowed.
11.2.7	Marijuana infused products will be limited to five servings per package.
11.3.1	Producers seeking registration as a Marijuana Infused Food Establishment must submit to the Division an application demonstrating that they meet the requirements set forth in these regulations. The application shall include:
11.3.1.3	Floor plan of the processing area identifying appliances to be used, food contact surfaces (types of materials used for contact surfaces must be described,) areas for refrigeration and dry good storage, and restroom facilities.;
11.3.1.5.3	Allow the Division access to the establishment as specified under subsection 10.4 and to the records specified under subsection 7.5.
11.3.2	Producers may first apply to the Division for registration as a Marijuana Infused Food Establishment on or after July 1, 2018.
11.3.6	Registration with the Division does not exempt the Marijuana Infused Food Establishment from other state, county or local codes unless specifically listed in subsection 2.4.
11.3.7.1	Private wells shall comply with chemical and bacteriological standards; a satisfactory analysis is required before a registration may be issued. Completion of any required sampling is the responsibility of the producers.
12.0	Marijuana Infused Food Establishment Registrant Requirements
12.1	Conditions of the Marijuana Infused Food Establishment Registration
12.1.1	Upon acceptance of the registration to operate a Marijuana Infused Food Establishment issued by the Division the registration holder shall:
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 in regard to the registration holder’s Marijuana Infused Food Establishment. Comply with the conditions of a granted variance, and conditions of approved facility plans and specifications;
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;
12.1.1.6.2	The Division directs the replacement of the facilities and equipment because of a change of ownership; or
12.1.1.6.3	The surfaces and equipment are replaced in the normal course of operation.
14.1.1	Only approved food items shall be made in the registered Marijuana Infused Food Establishment.
14.2	Quality Control Unit
14.2.1	Each cultivation facility, facility for the production of edible marijuana products or marijuana-infused products and medical marijuana dispensary shall have a quality control unit that:
14.2.1.1	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;
14.2.1.2	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;
14.2.1.3	Is responsible for approving or rejecting marijuana or marijuana products manufactured, processed, packaged or held under contract by another medical marijuana establishment; and
14.2.1.4	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.
14.2.2	Each cultivation facility, facility for the production of edible marijuana products or marijuana-infused products and medical marijuana dispensary shall:
14.2.2.1	Set forth the responsibilities and procedures applicable to the quality control unit in writing; and
14.2.2.2	Follow the written responsibilities and procedures set forth pursuant to subsection 7.3.12.3.
15.1.1.1.1.2	The surfaces of cooking equipment and pans that have direct contact with marijuana products are kept free of encrusted grease deposits and other soil accumulations; and
15.1.1.2.1.3	At any time during operation when contamination may have occurred; and
15.1.1.2.1.4	If they come into contact with potentially hazardous marijuana products and ingredients, surfaces and utensils are cleaned throughout the day at least once every 4 hours.
15.1.1.2.1.5	The surfaces of utensils and equipment that have direct contact with marijuana products and ingredients that are not potentially hazardous are cleaned:
15.1.1.2.1.5.1	At any time when contamination may have occurred; and
15.3.1	No animals/pets shall be permitted in the Marijuana Infused Food Establishment during the preparation, packaging, or handling of any marijuana infused food products.
16.1.1	All batches of food is required by the Division to be laboratory tested. Testing of food products shall be the financial responsibility of the producer.
16.2	Labeling
16.2.1	Products shall be properly labeled with the following: Name of Compassion Center, name of product, net weight, date of production / lot number, barcode, and cannabinoid profile.
16.2.2	Labels shall include a list of ingredients in decreasing order by weight. If the product label is too small to allow for printing of ingredients, the list shall be available at the request of the consumer.
16.2.3	Labels shall include the following statement “This food is made in a Marijuana Infused Food Establishment and is NOT subject to routine Government Food Safety Inspections”.
16.2.4	Labels shall be printed in at least 10-point type in a color that provides a clear contrast to the background label.
16.2.5	Additional information as required by the Division must be made available for review upon request from the consumer:
16.2.5.1	The date on which the product was manufactured;
16.2.5.2	If the product is perishable, a suggested use-by date;
16.2.5.3	The total milligrams of active cannabinoids and terpenoids in the product, as provided by the independent testing laboratory that tested the product;
16.2.5.4	A list of all ingredients and all major food allergens as identified in 21 U.S.C. §§343;
16.2.5.5	A warning that states: “Caution: When eaten or swallowed, the intoxicating effects of this drug may be delayed by 2 or more hours.”;
16.2.5.6	If a marijuana extract was added to the product, a disclosure of the type of extraction process and any solvent, gas or other chemical used in the extraction process, or any other compound added to the extract;
16.2.5.7	A warning that states: “This product may have intoxicating effects and may be habit forming.”;
16.2.5.8	The statement: “This product is unlawful outside of the State of Delaware.”; and
16.2.5.9	A medical marijuana dispensary must provide with all edible marijuana products and marijuana-infused products sold at retail accompanying material that discloses any products applied to the marijuana plants and growing medium during production of the marijuana used to create the extract added to the edible marijuana products or marijuana-infused products and the type of extraction method used, including, without limitation, any solvents, gases or other chemicals or compounds used to produce or that are added to the extract, and contains the following warnings:
16.2.5.9.1	“There may be health risks associated with consumption of this product.”;
16.2.5.9.2	“This product contains or is infused with marijuana or active compounds of marijuana.”;
16.2.5.9.3	“Should not be used by women who are pregnant or breast feeding.”;
16.2.5.9.4	“For use only by the person named on the label of the dispensed product. Keep out of the reach of children.”; and
16.2.5.9.5	“Products containing marijuana can impair concentration, coordination and judgment. Do not operate a vehicle or machinery under the influence of this drug.”
16.2.5.9.5.1	“Caution: When eaten or swallowed, the intoxicating effects of this drug may be delayed by 2 or more hours.”
16.3	Packaging
16.3.1	The immediate food contact surface of any product packaging material shall be food grade in quality, and therefore meet the food safety requirements of 16 Del.C. Ch. 33.
16.3.2	Any product containing marijuana must be packaged in child-resistant packaging in accordance with 16 C.F.R. §1700.
16.3.3	Marijuana-infused products must be packaged in plastic which is 4 millimeters or more in thickness and must be heat-sealed without an easy-open tab, dimple, and corner or flap so that it is difficult for a child to open and as a tamperproof measure.
16.3.4	Any container or packaging containing usable marijuana, edible marijuana products or marijuana-infused products must protect the contents from contamination and must not impart any toxic or deleterious substance to the usable marijuana or marijuana product.
16.4	Recall Plan
16.4.1	The Marijuana Infused Food Establishment shall:
16.4.1.1	Prepare and maintain a current written contingency plan for use in initiating and affecting a recall of products;
16.4.1.2	Use sufficient coding of regulated products to make possible positive identification and to facilitate effective recall of all violated lots; and
16.4.1.3	Maintain such product distribution records as are necessary to facilitate location of products that are being recalled. Such records shall be maintained for 3 years.
16.5	Reporting and Records
16.5.1	A Marijuana Infused Food Establishment must maintain records for each batch of product indicating type of finished product, date of production, lot number, and date and location of sales. These records shall be maintained for 3 years.
17.1	A person may not operate a Marijuana Infused Food Establishment without a valid registration to operate issued by the Division.
17.2	General
17.2.1	If the Division determines that a Marijuana Infused Food Establishment is operating without a valid registration; that one or more conditions exist which represent an imminent health hazard; or that serious violations, repeat violations, or general unsanitary conditions are found to exist, administrative action may occur. Administrative action will be conducted in accordance with the following:
17.2.1.1	Operation without a registration
17.2.1.1.1.1	If a Marijuana Infused Food Establishment is found operating without a registration as required by subsection 8.1 of this regulation, the Division shall order the establishment immediately closed.
17.2.1.1.3.1	The Marijuana Infused Food Establishment shall remain closed until a registration application; applicable fees and any required plans have been received and approved by the Division.
17.2.1.2.1	Registration suspension without hearing
17.2.1.2.1.1	If some condition is determined to exist in a marijuana business which presents an imminent health hazard to the public, the Division may suspend the registration of the marijuana establishment without a prior hearing. The suspension shall be effective upon receipt of written notice by the producer or employee of the marijuana establishment. A suspension statement recorded on an inspection report by the Division constitutes written notice.
17.2.2.2	Request, in writing, an administrative hearing with the Hearing Officer of the Division to contest the order to close.
17.2.2.2.2.3	The facility has the right to examine and cross-examine witnesses;
17.2.2.2.2.4	A stenographic recording will be made by a qualified court reporter. At the request and expense of any party, such record shall be transcribed with a copy to the other party; and
17.3.1.1	Any person who violates a provision of this regulation, and any person who is the holder of a permit or who otherwise operates a food establishment that does not comply with the requirements of this regulation shall be subject to the penalties found in 16 Del.C. §107.
18.1	The Office of Medical Marijuana (OMM) has set the maximum batch size as five (5) pounds or 2268 grams. Compassion centers may create any size batch they deem appropriate, but not more than 5 pounds. A batch is considered a collection of plants of the same strain and genetics, grown in the same room at the same time. The minimum sample size is set at 0.5% of batch weight. A 1 pound batch would require a 2 gram sample and a 5 pound batch would require an 11 gram sample. The minimum sample size for testing is 1 gram.
18.1.1	All medical marijuana products will be tested to identify any non-organic residual solvents, processing chemicals or foreign material, including, but not limited to, hair, insects, or similar or related adulterant. Quantification of cannabinoid profiles and potency is needed to determine appropriate dosing for an individual use. Additionally the lab will test for microbiological impurity, including total aerobic microbial count, total yeast mold count, P. aeruginosa, aspergillus spp., s. aureus, aflatoxin B1, B2, G1, G2, or ochratoxin A. Safety testing shall include E. coli, Salmonella and Streptococcus.
18.1.2	Compassion Centers will coordinate with the Office of Medical Marijuana (OMM) for collection of samples by State Regulators, who will supervise randomly chosen samples of each batch for testing by the Testing Center. Sample results will be loaded into the DEC3S system by the testing center allowing Compassion Centers to sell the material or incorporate it into other products.
18.2	Compassion Center Responsibility
18.2.1	Compassion Centers will coordinate harvest schedules with the Office of Medical Marijuana (OMM) and the Testing Center. After the marijuana has been harvested, dried and cured, the OMM staff will supervise selection of random samples from the curing vessels with the Compassion Center staff. Compassion Center staff will prepare additional barcode labels and tamper-proof containers for each batch and develop a transportation manifest, initiating the chain of custody process for the batch of plants being tested.
18.2.2	Compassion Centers will not sell or prepare products from the batch being tested until the testing centers enter the values into the DEC3S program, releasing the material for use or sale. Compassion Centers will be invoiced for payment of testing services directly from the Testing Center. All concentrates or other infused products must be sent to the Testing Center using the process listed above before they are cleared for sale.
18.3	Office of Medical Marijuana Responsibility
18.3.1	The Office of Medical Marijuana (OMM) will arrive at the Compassion Centers at a pre-designated time and date for the collection of samples. OMM staff will monitor Compassion Center staff, pull random samples from each batch harvested, and place the material into tamper-proof containers for testing. OMM staff will verify the sample container barcodes against the prepared manifest and co-sign the document to initiate the chain of custody.
18.3.1.1	Office of Medical Marijuana staff will transport samples to the testing center and acknowledge the transfer of the samples to the testing center. The testing center staff will verify the sample barcodes against the manifest by co-signing the manifest with the OMM staff.
18.3.1.2	OMM staff will secure and transport the sample material in an appropriate locked container.
18.4	Testing Facility Responsibility
18.4.1.1	Tetrahydrocannabinol (THC);
18.4.1.2	Tetrahydrocannabinolic Acid (THCA);
18.4.1.3	Cannabidiol (CBD);
18.4.1.4	Cannabidiolic Acid (CBDA);
18.4.1.5	Cannabigerol (CBG);
18.4.1.6	Cannabinol (CBN); and
18.4.1.7	That the presence of contaminants does not exceed the levels in the American Herbal Pharmacopoeia Monograph, Revision 2014, or the guidance from the Division of Public Health.
18.4.2.1	Residual solvent or processing chemicals;
18.4.2.2	Foreign material, including, but not limited to, hair, insects, or similar or related adulterant;
18.4.2.3	Microbiological impurity, including total aerobic microbial count, total yeast mold count, P. aeruginosa, aspergillus spp., s. aureus, aflatoxin B1, B2, G1, G2, or ochratoxin A, E. coli, and coliforms; and
18.4.3	Terpenes described in Revision 2014 of the cannabis inflorescence monograph published by the American Herbal Pharmacopoeia. Terpene testing will be done as required by the compassion centers to inform patients of the products formulization.
18.4.4	After the sample testing has been completed:
18.4.4.1	Testing Center will update DEC3S with the values associated with the tests. If the samples pass all tests, the barcode is unlocked and Compassion Centers will able to sell or use the marijuana in making other products or concentrates; and
18.5.4	If a sample tested fails one or more of the standards listed above, the DEC3S will lockout those barcodes until remediation or corrective action is completed. If remediation is not possible, the compassion center will coordinate with the Office of Medical Marijuana on disposition or the batch must be destroyed.
20.1	A licensee may seek a variance from these regulations by making a request for variance to the Division. The Division may grant a variance by modifying or waiving the requirements of these regulations if, in the opinion of the Division, a health hazard or nuisance will not result from the variance.
22 DE Reg. 652 (02/01/19) (Prop.)