Unless otherwise specified, this chapter applies to a business licensed to process cannabis under COMAR 14.17.06.07 and COMAR 14.17.07.06. A processor premises shall: Be located within Maryland; Conform to local zoning and planning requirements; and Conspicuously display a processor license at the licensed premises. A processor may not make modifications or renovations to a processor premises without prior approval by the Administration in a manner prescribed by the Administration. A processor facility premises shall be constructed to prevent unauthorized entry. The processor shall design and install lighting fixtures to ensure proper surveillance. Security Alarm Systems. A processor shall maintain a security alarm system that covers all: Perimeter entry points and portals at all premises; Rooms that hold cannabis; Locations where records are stored on-site; and Locations where records are stored off-site. A security system shall: Be continuously monitored; Be capable of detecting smoke and fire; Be capable of detecting power loss; Include panic alarm devices mounted at convenient, readily accessible locations throughout the licensed premises; Remain operational until a licensed premises no longer has any cannabis, seeds, or cuttings on the premises; and Be equipped with auxiliary power sufficient to maintain operation for at least 48 hours. Video Surveillance Requirements. A processor shall maintain a motion-activated video surveillance recording system at all premises that: Records all activity in images of high quality and high resolution capable of clearly revealing facial detail; Operates 24-hours a day, 365 days a year without interruption; and Provides a date and time stamp for every recorded frame. A processor shall post appropriate notices advising visitors of the video surveillance. A surveillance camera shall be located and operated to capture each exit from the premises. A surveillance camera shall capture activity at each: Entrance to an area where cannabis is processed, tested, packaged, or stored; and Area where cannabis is processed, packaged, or stored. The storage of all recordings of security video surveillance shall be: Access-limited; Secured by a security alarm system that is independent of the main premises security alarm system; In a format that can be easily accessed for investigational purposes; and Retained for a minimum of 90 calendar days. Any recording of security video surveillance shall be made available to the Administration or law enforcement agency for just cause as requested within 48 hours. Violation. Failure to provide the Administration with any recording of video surveillance within 48 hours of a request from the Administration is a violation of COMAR 14.17.14.04. Each day of recording within the time frame stated in §F(5)(d) of this regulation that a processor fails to provide to the Administration constitutes a separate violation. Handwashing Sinks. A processor shall: Ensure that agents engaged in creating usable cannabis products have easy access to a handwashing sink that provides warm water of sufficient volume under pressure for effective handwashing procedures; and Maintain at least one handwashing sink for the following number of agents who are engaged in creating usable cannabis products while on duty at the same time: Every 15 agents; and Any fraction of 15 agents. A processor shall: Create and enter timely and accurate data into the seed-to-sale tracking system to identify and track the processor’s stock of cannabis from the time it is delivered or produced to the time it is delivered to another licensee; and At least monthly, conduct a physical inventory of the stock and compare the physical inventory of stock with the stock reflected in the seed-to-sale tracking system. Receipt of Products Containing Cannabis. A processor may not: Acquire cannabis from an individual or entity in Maryland other than a licensee; Acquire cannabis from outside of Maryland unless authorized by the Administration; or Transport cannabis to any place outside of Maryland. Hemp. A processor may acquire hemp, as defined in Agriculture Article, §14-101, Annotated Code of Maryland, from a person licensed to produce hemp by: The Maryland Department of Agriculture; The Secretary of the U.S. Department of Agriculture; or An agency of another state pursuant to a hemp production plan that has been approved by the Secretary of the U.S. Department of Agriculture. Any product derived from hemp shall comply with: The testing standards established in COMAR 14.17.08 and the Technical Authority; The relevant manufacturing standards established in this chapter and COMAR 14.17.13; and The relevant packaging and labeling standards established in COMAR 14.17.18. A licensed processor shall: After placing an order to acquire hemp and before accepting delivery of hemp, submit a request for Administration approval to acquire hemp in the manner specified by the Administration. Follow the process for receiving cannabis established in this regulation. Sanitary Storage of Cannabis. A processor shall: Maintain the cleanliness of any building or equipment used to store or display cannabis; Ensure cannabis is free from contamination; Require a processor agent to report any personal health condition that might compromise the cleanliness or quality of the cannabis the processor agent might handle; Dispose and segregate storage of any cannabis: That is outdated, damaged, deteriorated, misbranded, or adulterated; or Whose containers or packages have been improperly or accidentally opened. Equipment Sanitation, Accuracy, and Maintenance of Logs. A processor shall: Maintain the sanitation of equipment that comes in contact with cannabis; Ensure all scales are National Type Evaluation Program-approved; Ensure that any scale, balance, or other measurement device and any automatic, mechanical, or electronic equipment is: Annually calibrated by a calibration laboratory accredited to International Organization for Standardization (ISO) standard 17025 ISO/IEC by an accreditation body that is signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement; and Checked at least once each month to ensure accuracy; Maintain an accurate log recording the: Cleaning of equipment; The maintenance of equipment; and The calibration of equipment; and Make records and certifications required under §D(2) and (3) of this regulation available to the Administration available upon request. Sanitation. Scales, surfaces, and other equipment use for the purposes of creating usable cannabis products shall be cleaned and sanitized: Between shifts; Between packaging, repackaging, or otherwise creation of usable cannabis products with different usable cannabis batches; Before beginning any packaging, repackaging, or otherwise creation of usable cannabis products; and After the completion of any packaging or creation of usable cannabis products. A processor shall maintain an accurate log of cleaning and sanitation required under §E(1) of this regulation. Controls for Processing of Cannabis Concentrates and Cannabis-Infused Products. A licensed processor of cannabis concentrates and cannabis-infused products shall: Develop standard operating procedures in accordance with COMAR 14.17.11.19, good manufacturing practices, and a training plan before producing cannabis concentrates and cannabis-infused products; Require that any person involved in processing cannabis concentrates and cannabis-infused products: Is appropriately trained in accordance with their job description to safely operate and maintain the system used for processing; Has direct access to applicable material safety sheets and labels; and Follows OSHA protocols for handling and storage of all chemicals; Assign a unique lot number to each lot of cannabis concentrate or cannabis-infused product; If using a solvent-based extraction method, ensure solvents are at least 99 percent pure; Require: The use of solvents in a professional grade, closed-loop extraction system designed to recover the solvents; Work in a spark-free environment with proper ventilation; and Following all applicable OSHA regulations, and local fire, safety, and building codes in the processing and storage of the solvents; and If using carbon dioxide gas extraction, ensure: Every vessel is rated to a minimum of 900 pounds per square inch; The use of a professional grade, closed-loop system; and The use of carbon dioxide that is at least 99 percent pure. A licensed processor may use heat, screens, presses, steam distillation, ice water, and other methods to produce cannabis concentrates. Upon successful completion of a validation process, the licensed processor shall use an Administration-registered independent testing laboratory to test each unique lot of cannabis concentrate or cannabis-infused product and obtain a certificate of analysis. Batch Release Controls. If a licensed processor, upon review of the certificate of analysis, determines that a lot meets the specification for the product, the licensed processor may: Assign an expiration date to the lot; Release the lot for distribution; and Revise the status of the lot in the seed-to-sale tracking system. If a licensed processor receives test results that the lot falls outside action limits, the licensed processor: May rework or reprocess the lot according to their standard operating procedure; and If applicable, shall ensure the reworked or reprocessed lot is resampled and retested by the independent testing laboratory to meet all required specifications. A licensed processor shall retain every certificate of analysis. All cannabis products shall have a certificate of analysis, as specified in COMAR 14.17.08.05A(5), prior to transfer to a licensed dispensary. Stability Testing and Retention Sampling. A processor shall provide a sample from each unique lot to an independent testing laboratory sufficient to perform stability testing at 6-month intervals to: Ensure product potency and purity; and Provide support for expiration dating. Retention samples retained from each released lot shall be: Tested by the State Cannabis Testing Laboratory following an adverse event reported to the Administration; Properly stored by the licensed processor; and Properly discarded 6 months after the expiration date of the lot. Correction and Prevention Action. If a processor’s test results indicate the confirmed presence of a pathogen more than once in a 60-day period, the processor shall: Conduct environmental swab testing as required by the Administration’s Technical Authority; Conduct an investigation to determine the root cause of contamination; Decontaminate all areas, including rooms, equipment, and surfaces used for cannabis product processing; Provide, in the manner designated by the Administration: A report of the investigation; and The licensee’s corrective action plan; and If applicable, update and implement standard operating procedures needed to ensure passing samples in the future. The Administration may require a processor to: Conduct further investigation; and Implement additional procedures to prevent future contamination. A processor that produces edible cannabis products as defined in COMAR 14.17.01 shall maintain facilities and manufacture and transport edible products in accordance with this regulation, Regulations .06—.14 of this chapter, and COMAR 14.17.13.05. Issuance of Permit. Before engaging in the business of possessing, processing, packaging, labeling, transferring, transporting, selling, or distributing edible cannabis products, a processor shall obtain a permit from the Administration. To obtain a permit, a processor shall: Submit a completed permit application; Pay the registration fee specified in COMAR 14.17.21; Make available all edible cannabis product processing standard operating procedures required by Regulation .19 of this chapter; Pass a pre-operation inspection; and Conspicuously post applicable State and local licenses at the licensed premises. The processor may apply for a permit to manufacture edible cannabis products at: The processor’s premises; or A facility under the legal control of the processor that meets: All zoning and planning requirements; and The requirements of this chapter. The Administration may deny a permit if the processor: Violates or fails to meet the requirements of this chapter; or Fraudulently or deceptively attempts to obtain a permit. Trade Secrets. A processor shall provide the Administration with the recipe for each edible cannabis product prior to offering the product for distribution or sale to a licensed dispensary. A processor shall notify the Administration of any ingredient or recipe that the processor considers a trade secret. The Administration shall maintain the confidentiality of trade secret information in accordance with State Government Article, §10-617, and Health-General Article, §21-259, Annotated Code of Maryland. If the Administration determines that the information about an ingredient or recipe is necessary to conduct a disease outbreak investigation, the Administration may disclose the trade secret to the appropriate investigators. In Regulations .05—.14 of this chapter, the following terms have the meaning indicated. Terms Defined. “Approved source” means a source of: Cannabis approved, licensed, and regulated by the Administration; or Food ingredients regulated by an approving authority. “Approving authority” means the agency designated in the laws of Maryland, another state, or another country to license or permit a food processing plant. “Commercially sterile” means the condition achieved by the: Application of heat, pressure, or other energy or matter that renders a food ingredient free of: Microorganisms capable of reproducing in the food ingredient under normal non-refrigerated conditions of storage and distribution; and Viable microorganisms, including spores, that cause disease; or Control of water activity and the application of heat, pressure, or other energy or matter that renders the food ingredient free of microorganisms capable of reproducing in the food ingredient under normal non-refrigerated conditions of storage and distribution. “Cookware” means items used during the processing of ingredients or edible cannabis products, including pots, pans, utensils, and containers. “Critical control point” means a point in the receiving, storage, processing, or distribution of ingredients or edible cannabis products where there is a reasonable likelihood that improper control may cause, allow, or contribute to a hazard to public health. Critical Item. “Critical item” means a safety requirement that if violated requires: Immediate correction; Destruction of any ingredients or edible cannabis products which may be affected; The cessation of some or all processing operations; or Closure of the licensed premises. “Critical item” includes the following requirements: Food ingredients be obtained from an approved source and approved for human consumption by an approving authority; Cannabis ingredients be obtained from an approved source; All ingredients and edible cannabis products be protected from contamination; All processes provide safe edible cannabis products with proper control at critical control points; Licensed processor sanitation be adequate, provide safety, and prevent illness transmissible through edible cannabis products or ingredients; Equipment allows for proper processing and sanitation; Edible cannabis products be packaged and labeled for safety; A sufficient volume of potable hot and cold water supply under adequate pressure be available to facilitate proper handwashing procedures outlined in this chapter; and Sewage be discharged in compliance with applicable laws and regulations. “Food” means any substance that is used as food or drink for human beings or as a component of food or drink for human beings. “Food ingredient” means a substance that is used as a component of food, including: Flavoring; Food coloring; and Preservatives. “Ingredient” means any component of an edible cannabis product that is intended for human consumption, approved by the Administration, and composed of: Food or food ingredients; or Cannabis. “Permit” means a permit issued by the Administration to a licensed processor for the purpose of manufacturing edible cannabis products. “Permittee” means a licensed processor authorized by the Administration to manufacture edible cannabis products. Potentially Hazardous Edible Cannabis Product. “Potentially hazardous edible cannabis product” means an edible cannabis product that requires temperature control because the product is in a form capable of supporting: The rapid and progressive growth of infectious or toxigenic microorganisms; or The growth and toxin production of Clostridium botulinum. “Potentially hazardous edible cannabis product” does not include products with a water activity (aw) value of 0.85 or less. Potentially Hazardous Ingredient. “Potentially hazardous ingredient” means a natural or synthetic component of food or an edible cannabis product intended for human consumption that requires temperature control because the ingredient is in a form capable of supporting the: Rapid and progressive growth of infectious or toxigenic microorganisms; or Growth and toxin production of Clostridium botulinum. “Potentially hazardous ingredient” does not include an ingredient with a: Water activity (aw) value of 0.85 or less; Commercially sterile ingredient in a hermetically sealed container. “Quarantine area” means an area within a licensed premise in which ingredients, cannabis, or cannabis finished products that may be contaminated are temporarily stored prior to disposal or collection by a public health agency. The premises and operations shall conform to all local zoning and planning requirements. A permittee shall conspicuously display at the premises a permit to process edible cannabis products. No modifications or renovations to licensed processor premises shall be undertaken without prior approval by the Maryland Cannabis Administration. The premises shall be completely separated from an area used as living quarters by solid, impervious floors, walls, and ceilings with no connecting openings. A room or area in which ingredients or edible cannabis products are processed or stored, or in which cookware equipment is cleaned, sanitized, or stored, shall: Be separated from other rooms or areas at the licensed premises by tight walls, ceilings, and self-closing doors; Be refrigerated or mechanically ventilated using exhaust and supply fans to: Remove grease vapors, steam, condensation, heat, and odor; Provide filtered air and positive air pressure to the room; and Prevent condensation and grease from accumulating on surfaces and equipment; Have a floor, ceiling, and walls that are smooth, washable, and impervious to water; Have floor-wall joints that are coved and impervious to water; and Prevent overhead pipes, ducts, conduits, evaporators, and other structures required to manufacture edible cannabis products from: Being located over ingredient or edible cannabis product storage, preparation, manufacturing, packaging, or labeling areas; and Leaking on or contaminating ingredients, edible cannabis products, cookware, or packaging or labeling materials. Artificial Lighting. A room or area in which ingredients or edible cannabis products are processed or stored, or in which cookware or equipment are cleaned, sanitized, or stored, shall have artificial lights that provide at a minimum: 40-foot candles of light on all work surfaces used for processing and warewashing; and 20-foot candles of light on surfaces used solely for storage. The artificial lighting shall consist of: Shatter-resistant bulbs; or Light shields that protect exposed light bulbs or fixtures from breakage and prevent glass fragments from contacting ingredients, edible cannabis products, or contact surfaces. Floor Drains. The permittee shall: If a floor receives water because of processing or cleaning, install and maintain floor drains at a rate of one floor drain for every 400 square feet of floor area; and Ensure that the floor is sloped to one or more floor drains at a pitch of 1/8 to 1/4 inch per foot. Pooling or standing water is not allowed. Lavatories. The premises shall be constructed to include: A separate, gender-segregated lavatory for men and women, or a gender-neutral lavatory; and One toilet for the following number of agents who are on duty at the same time: Every 15 agents; and Any fraction of 15 agents. A lavatory may not open directly into an area in which: Ingredients or edible cannabis products are stored, processed, packaged, or labeled; or Cookware or equipment is washed or stored. Each lavatory shall be equipped with: Ventilation with mechanical air exhaust at the rate of 2 cubic feet per minute of air for each square foot of floor area or a screened window that allows the entrance of outside air; Easily cleanable and durable walls and ceiling; A smooth, impervious, and easily cleanable floor; Artificial lighting that provides 20-foot candles of light when measured 30 inches above the floor; A handwashing sink; Soap; Paper towels or warm air hand drying devices; Warm water of sufficient volume under pressure for effective handwashing; and A covered trash receptacle. Non-Green Waste. The premises shall include non-green waste containers that are: Adequate in number to maintain sanitary conditions; Accessible to agents at locations where non-green waste is generated; Labeled as not suitable for any green waste; Easily cleanable; and Placed on a hard and impermeable surface. Non-green waste containers located inside shall be leak-proof and emptied and cleaned at least daily. Non-green waste containers located outdoors shall be: Impervious to leaks, vermin, and insects; Equipped with a drain that conveys wastewater from the container directly into a sewerage system that meets all applicable State and local codes and properly disposes of the wastewater; Large enough to hold waste until the waste is taken off-site; and Covered. In any event where the permittee is unable to ensure adequate sanitation, such as during an electrical outage or water shut-off, the permittee shall: Cease all edible cannabis processing; Conduct a risk analysis to determine whether any ingredients, edible cannabis products, or packaging or labeling materials were contaminated; and Notify the Administration within 24 hours of the event. Ingredients and other supplies necessary to process edible cannabis products shall be received in a designated area identified in the standard operating procedures. This regulation does not apply to the receipt of cannabis, cannabis concentrates, or cannabis-infused products that are not intended to be used as an ingredient in edible cannabis products. Each receiving area shall have a barrier that reasonably prevents the entry of: Insects; Vermin; Pathogenic microorganisms; Toxic or deleterious chemicals; Foreign matter; Dust; or Animals. Any dock or overhead door may only be open when ingredients, edible cannabis products, waste, or other items are: Received; Removed from the premises; or Moved between receiving areas. Upon receipt of each delivery, a permittee shall: Inspect the delivery for damage and potential contamination; Inspect the delivery for potentially hazardous ingredients; Enter timely and accurate temperature data for potentially hazardous ingredients; and Confirm that each: Delivery is not damaged or contaminated; or Damaged or contaminated item is recorded in the receiving log. All ingredients shall be clearly labeled by the permittee with the: Name of the ingredient; Batch or lot number; Date of receipt; and Expiration or use-by date. A permittee shall maintain for at least 2 years a log of the: Date and time of each delivery of ingredients; Name and quantity of ingredients received; Batch or lot number of each ingredient received; Temperature data required under §E(3) of this regulation; Name of the product manufacturer or licensee and, if different, the name of the shipping company; and Name of processor agent responsible for receiving the shipment. All food ingredients shall be produced by a commercial manufacturer that is licensed by an approving authority. Spoiled, unwholesome, vermin-infested, or insect-infested ingredients are not allowed onto the premises and shall be: Removed immediately from the premises and properly disposed of; If it is not practicable to remove immediately, placed in a quarantine area temporarily until proper disposal; or If deemed necessary as part of an investigation by the Administration or other State, local, or federal regulatory agency, placed in a quarantine area until collection. All ingredients and edible cannabis products shall be kept in a secure controlled environment that: Meets the requirements set forth in this chapter; and Is a dry storage area, refrigerated storage area, or freezer storage area. Storage standard operating procedures shall preserve freshness, prevent contamination, and maintain cannabinoid content of any ingredients or edible cannabis products. Food ingredients may not be stored in the same areas as cannabis unless as outlined in standard operating procedures and approved by the Administration. Storage equipment shall be positioned so that: Storage surfaces are at least 6 inches: Above the floors; and Away from the walls; and Ingredient contact surfaces are at least 18 inches above the floor. Dry Storage Area. A dry storage area shall be maintained between 50°F and 70°F. A dry storage area shall have: Adequate ventilation to remain below 60 percent relative humidity; and A thermometer and hygrometer in plain sight that are calibrated based on the manufacturer’s recommendations to ensure accuracy. Refrigerated Storage Area. A refrigerated storage area shall: Be maintained at or below 40°F; and Have thermometers that are easily readable and accurate to plus or minus 2°F. A permittee shall: Position a temperature sensor to register the warmest air in the temperature-controlled space; or Have several thermometers throughout the area to ensure accuracy, consistency, and adequate cooling. A refrigerator unit shall have doors that close tightly and seal fully. In the case of a power outage, if the refrigerator unit: Remains below 40°F for the duration of the power outage, the refrigerator contents are considered safe; and Rises above 40°F for more than 2 hours, then: Any ingredients or edible cannabis products shall be discarded; and The permittee shall notify the Administration within 24 hours. If any ingredients or edible cannabis products that were stored in the refrigerator do not require temperature control for safety, a permittee may conduct a risk analysis to determine whether the ingredients or edible cannabis products remain safe for human consumption. The permittee shall maintain a record of any risk analysis conducted, the agent responsible for the risk analysis, and any ingredients or edible cannabis products that the permittee determines remain safe for human consumption. Freezer Storage Area. A freezer storage area shall: Be maintained at or below 0°F; and Have thermometers that are easily readable and accurate to plus or minus 2°F. A permittee shall: Position a temperature sensor to register the warmest air in the temperature-controlled space; or Have several thermometers throughout the area to ensure accuracy, consistency, and adequate cooling. A freezer unit shall have doors that close tightly and seal fully. In the case of a power outage, if the freezer unit: Remains at or below 0°F for the duration of the power outage, its contents are considered safe; and Rises above 0°F for more than 2 hours, then: Any ingredients or edible cannabis products that were stored in the freezer shall be discarded; and The permittee shall notify the Administration within 24 hours. If any ingredients or edible cannabis products that were stored in the freezer do not require temperature control for safety, a permittee may conduct a risk analysis to determine whether the ingredients or edible cannabis products remain safe for human consumption. The permittee shall maintain a record of any risk analysis conducted, the agent responsible for the risk analysis, and any ingredients or edible cannabis products that the permittee determines remain safe for human consumption. Potentially Hazardous Ingredients. The internal temperature of a potentially hazardous ingredient shall: Be kept at 41°F or less, or 135°F or greater; and For ingredients with a non-proteolytic Clostridium botulinum potential hazard, be kept at 38°F or less during refrigerated storage. When the internal temperature of a potentially hazardous ingredient is kept at temperatures other than specified in §J(1) of this regulation: A scheduled process approved by the Administration, specifying the temperature and amount of time at that temperature, shall be used; and Documentation of any corrective action taken and the agent responsible for monitoring the corrective action plan shall be kept for a minimum of 2 years and made available to the Administration upon request. All ingredients and edible cannabis products shall be clearly labeled and stored in a manner that: Facilitates first-expired, first-out (FEFO) procedures; and Is approved by the Administration. Each temperature-controlled equipment unit shall have a temperature sensor visible from outside of the temperature-controlled equipment unit. For each dry storage area, refrigerator storage area, and freezer storage area, a permittee shall: Monitor the temperature 24 hours a day, 365 days a year without interruption; Document the temperature at least two times a day, 365 days a year without interruption; and If outside the specified temperature range, document the time, date, any appropriate corrective action, and the agent responsible for monitoring the corrective action plan. Poisonous or Toxic Materials. A permittee shall ensure that any poisonous or toxic materials are: Kept in the original bulk container before use; Prominently and distinctively marked or labeled for easy identification; Used in accordance with manufacturer’s guidelines; and Not used or stored in a way that is likely to contaminate cannabis, ingredients, edible cannabis products, or packaging and labeling materials. A permittee shall make a safety data sheet that is specific to any poisonous or toxic material available to each agent in a form that the agent understands. General Requirements. The permittee shall prevent any ingredient or edible cannabis product from coming into contact with a surface or substance other than a clean and sanitary surface or substance intended for food contact or incorporation into food. Any heating and cooling equipment in close contact with ingredients or edible cannabis products shall be: Food grade; Approved for use in food processing areas; or Designed to prevent any contact with any ingredient or edible cannabis product. The permittee shall ensure that: The warewashing area includes a three-compartment sink able to hold and wash cookware and equipment in the kitchen; Larger cookware or equipment that cannot have at least 50 percent of its contact surface submerged in the three-compartment sink complies with approved standard operating procedures for cleaning and sanitizing the cookware or equipment; Agents are trained to clean the larger cookware and equipment according to the standard operating procedures; and A log is maintained for 2 years detailing the date, time, and agent responsible for cleaning and sanitizing the larger cookware or equipment. Equipment used to process ingredients and edible cannabis products shall be: Maintained in a sanitary and working condition; Tested and calibrated according to the equipment manufacturer’s instructions to ensure accuracy; and Positioned in a manner that does not impede proper cleaning and sanitation procedures. Equipment used to process ingredients and edible cannabis products shall meet design standards intended for food production equipment, such as those established by the: National Sanitation Foundation (NSF); Bakery Industry Sanitation Standards Committee; National Automatic Merchandising Association; International Association of Milk and Food Sanitarians; American Society of Mechanical Engineers; or U.S. Department of Agriculture. A thermometer used to monitor the temperature of any ingredient, edible cannabis product, or storage area shall be: Validated at least once per month using standard operating procedures approved by the Administration; and Calibrated based on the manufacturer’s recommendations to ensure accuracy, and at a minimum: Annually; or When validation procedures identify a thermometer is not accurate to plus or minus 2°F. Contact Surfaces. Materials used as contact surfaces of equipment or cookware shall be: Nontoxic; Inert to ingredients; Nonporous and nonabsorbent; Corrosion-resistant; Durable; If stainless steel, made of stainless steel of American Iron and Steel Institute Type 304, or equivalent; and Maintained in good condition. Contact surfaces of equipment or cookware shall be designed, constructed, and maintained to be: Smooth; Easily cleanable; Free of difficult-to-clean internal surfaces; Self-emptying or self-draining if an interior surface; Visible for inspection or readily disassembled for inspection; If manually cleaned: Readily accessible for cleaning without tools; or If not readily accessible, readily disassembled for cleaning with the use of simple tools kept available near the equipment; and If cleaned and sanitized by pressurized cleaning-in-place system, readily accessible to the cleaning and sanitizing solutions without disassembly. General Requirements. A permittee shall establish standard operating procedures for cleaning and sanitizing any surface, cookware, or equipment that comes into contact with ingredients or edible cannabis products that: Ensure proper sanitation throughout the premises; Are available to each agent in a form the agent understands; and Are approved by the Administration. Any surface that comes into contact with ingredients or edible cannabis products shall be cleaned and sanitized: In accordance with cleaning and sanitation procedures for food contact surfaces of cookware and equipment specified in COMAR 10.15.03; After preparing potentially hazardous ingredients; and When there is an interruption in processing of greater than 2 hours. The permittee shall use a cleaning and sanitizing schedule and procedure demonstrated by scientific evidence to kill pathogens and be safe for use on surfaces that come into contact with ingredients and edible cannabis products. Any surface that only comes into contact with fully processed edible cannabis products shall be cleaned and sanitized: Each time more than 8 hours elapse between the start of processing and the previous cleaning and sanitizing; If processing more than one type of edible cannabis product, at a frequency sufficient to prevent cross-contamination of allergens or different dosage forms; After processing has been completed; When there is an interruption in processing of greater than 2 hours; and As often as needed during processing to prevent contamination of edible cannabis products. Any surface, utensil, or equipment that does not contact ingredients or edible cannabis products shall be cleaned: According to COMAR 10.15.04; and As often as necessary to maintain sanitary conditions. Vermin and insects shall be eliminated so that there is minimal potential for contamination of ingredients or edible cannabis products. Pesticides may not be used to exterminate vermin unless: Approved for use in food processing areas; or The permittee: Applies the pesticides only in areas not used for storage or processing of ingredients or edible cannabis products; and Accurately enters the data into the seed-to-sale tracking system. The permittee shall ensure that each agent: Practices good personal hygiene and does not contaminate ingredients or edible cannabis products; Wears clean outerwear and, if necessary, a hair or beard covering, or both; Wears gloves when handling any cannabis plant material or cannabis concentrate; If wearing gloves: Uses gloves that are intended for food contact; Washes their hands thoroughly before putting on the gloves; and Washes their hands and replaces the gloves in accordance with COMAR 10.15.03.14J and after an activity that: Is likely to soil the gloves; or Damages the gloves; If not wearing gloves, washes their hands and the exposed portions of their arms: Frequently, and after an activity that is likely to soil their hands; Immediately upon entrance to any area containing ingredients or edible cannabis products; Immediately before engaging in preparation for the production of edible cannabis products; After using the lavatory; After coughing, sneezing, or using a handkerchief or disposable tissue; After using tobacco; After eating or drinking; After handling soiled linens, equipment, or cookware; During preparation for production of edible cannabis products, as often as necessary to remove soil and contamination and to prevent cross-contamination when changing tasks; When switching between working with ingredients or unfinished edible cannabis products and working with fully processed edible cannabis products; Before donning gloves for working with edible cannabis products or ingredients; and After engaging in any other activities that may contaminate the hands; If handling ingredients or edible cannabis products, maintains trim and clean fingernails and does not wear artificial fingernails; and Is excluded from working with ingredients or edible cannabis products, packaging materials, labeling materials, clean equipment, clean utensils, or clean linens: If the agent has any disease caused by: Entamoeba histolytica; Vibrio cholera; Staphylococcus aureus; Escherichia coli O157:H7or other Enterohemorrhagic or Shiga-toxin producing Escherichia coli; Hepatitis A; Salmonella spp.; Shigella spp.; Norovirus; Group A beta-hemolytic Streptococcus; or Salmonella Typhi, typhoid-like fever or carrier thereof; If the agent has an: Illness transmissible through food or edible cannabis products; or Exposed and open sore or cut; or If the agent is experiencing: Persistent sneezing, coughing, or a runny nose that causes discharges from the eyes, nose, or mouth; Fever; Diarrhea, unless a physician has certified the agent as noninfectious; Vomiting; or Jaundice, unless a physician has certified the agent as noninfectious. The premises shall ensure good personal hygiene by providing: Lockers or similar storage facilities for the secure storage of personal items in a designated non-working area; Adequate hand-washing facilities as set forth in this chapter; Signage in each lavatory that instructs agents to wash their hands before returning to work; A water fountain or other water dispenser that provides potable water without the use of reusable cups; An area for agents to consume food and beverages that is not used in conjunction with the processing or storage of: Ingredients; Edible cannabis products; Packaging and labeling materials; or Cookware; and If necessary, to ensure safety and sanitation, sanitizer foot baths, footwear covers, or hand dips. The permittee shall: Ensure that each agent who handles ingredients or edible cannabis products successfully completes a food handler certificate course, from an entity accredited by the American National Standards Institute (ANSI) or an equivalent food safety accrediting body: Within 90 days of commencing employment at the premises; and Every 3 years during employment; and Maintain a log of agent training in ingredient and edible cannabis product handling. Potentially hazardous edible cannabis products may not be manufactured unless approved by the Administration. A permittee shall ensure: The consistent and safe manufacture of edible cannabis products; Pathogenic microorganisms are excluded or eliminated from edible cannabis products before being offered for human consumption; All edible cannabis products undergo thermal processing or another process scientifically proven to kill pathogenic microorganisms that pose a threat to human health, as outlined in applicable standard operating procedures and approved by the Administration; The heating, cooling, or re-heating of ingredients or edible cannabis products use methods that prevent contamination; and All edible cannabis products are safe for human consumption. The permittee shall provide a shelf-life study in accordance with the Administration’s Technical Authority for cannabis testing, to prove the manufacturing processes prevent contamination of edible cannabis products or premature degradation of therapeutic compounds. If transporting or shipping edible cannabis products that require temperature control for safety and stability, a permittee shall ensure the vehicle or transportation equipment: Provides adequate temperature control to prevent the edible cannabis products from becoming unsafe during transport; and Complies with the requirements established in 21 CFR §1.908(c). A permittee shall maintain a detailed log of the temperature of the edible cannabis products at the time of departure for at least 2 years. The receiving licensee shall maintain a detailed log of the temperature of the edible cannabis products at the time of arrival at the licensed dispensary for at least 2 years. If any edible cannabis products are declined upon arrival to the licensed dispensary due to contamination, damage, or an unsafe temperature, the permittee shall, within 24 hours: Document the declination and the reason for the declination in the seed-to-sale tracking system; and Dispose of the rejected material in accordance with the permittee’s approved green waste disposal plan. Micro processors may not process more cannabis than the limits established in Alcoholic Beverages and Cannabis Article, §36-401(c)(2)(ii), Annotated Code of Maryland A processor shall accept any product returned for destruction and record as green waste. A processor shall otherwise destroy any other product recorded as green waste in accordance with standard operating procedures. When a visitor is admitted to an area of the premises used for cannabis operations, a registered agent shall: Log the visitor in and out; Retain with the log a photocopy of the visitor’s government-issued identification; Continuously, physically supervise the visitor while they are on the premises; and Ensure that the visitor does not touch any cannabis. An Administration investigator is not subject to the visitor requirements established in §A of this regulation. The processor shall maintain a log of all visitors for 2 years. A firefighter, a rescue squad member, law enforcement officer, or emergency medical services personnel who is actively responding to a call for emergency services is not subject to §A(1)—(3) of this regulation. Discrepancy Reporting. If a processor discerns a discrepancy between the inventory of stock and the seed-to-sale tracking system outside of normal weight loss due to moisture loss and handling, the processor shall: Commence an investigation of the discrepancy within 1 business day; and If the processor cannot resolve the discrepancy within 30 business days, report the discrepancy to MCA. Failure to report an unresolved discrepancy may be used as evidence of diversion. Theft or Diversion. If the processor finds evidence of a theft or diversion, the processor shall report the theft or diversion to the Administration within 1 business day. Within 30 business days of discovering the theft, diversion, or unresolved discrepancy, the processor shall: Complete an investigation; Amend its standard operating procedures, if necessary; and Send a report of the investigation to the Administration. A processor shall establish standard operating procedures for all aspects of: Inventory control, including: Identifying and tracking the processor’s stock of cannabis in the seed-to-sale tracking system; and Monthly physical inventory; Receiving, shipping, and transporting cannabis or products containing cannabis; Sanitation, including: Storage of cannabis; Maintaining the sanitation of equipment that comes into contact with cannabis; and Good hygiene practices and the wearing of protective clothing by agents; Equipment maintenance and calibration; Handling, packaging, and labeling cannabis and cannabis products; Reworking or reprocessing a lot if the processor receives a test result that the lot does not meet specifications; Green waste procedures; Security and visitor procedures, including theft and diversion procedures; Storage, handling, and disposing of recalled materials; Producing cannabis concentrates and cannabis-infused products, including: Methods, equipment, solvents, and gases when processing cannabis concentrates and cannabis-infused products; Use of solvents in a professional grade, closed-loop extraction system designed to recover the solvents; Work in a spark-free environment with proper ventilation; Following all applicable OSHA regulations, and local fire, safety, and building codes in the processing and storage of the solvents; and If applicable, carbon dioxide extraction; Decontamination, including but not limited to: Preventing contamination; Investigating decontaminating after presumptive positive pathogen detection; and Remediation steps and resulting environmental analysis. If applicable, producing edible cannabis products, including receipt of ingredients, storage, equipment maintenance, sanitation, manufacture, and transport; and If applicable, co-locating with another licensee, including: Sharing equipment and production materials; and Maintaining independent and unique security and video surveillance control. A processor’s standard operating procedures shall: Be available to each agent in a form the agent understands; Be available on-site for inspection by the Administration; and Accurately reflect the procedures used at the premises. Alcoholic Beverages and Cannabis Article, §§36-202, 36-203, and 36-401, Annotated Code of Maryland Effective date: Regulations .01—.07 adopted as an emergency provision effective July 1, 2023 (50:14 Md. R. 559); emergency status expired June 30, 2024 Regulations .01—.19 adopted as an emergency provision effective June 7, 2024 (51:14 Md. R. 676) Regulations .01—.19 adopted effective July 22, 2024 (51:14 Md. R. 678) Regulation .03B amended effective March 16, 2026 (53:5 Md. R. 244) Regulation .04C amended effective April 14, 2025 (52:7 Md. R. 324) Regulation .04E adopted effective March 16, 2026 (53:5 Md. R. 244) Regulation .17D adopted effective March 16, 2026 (53:5 Md. R. 244) Regulation .18B amended effective April 14, 2025 (52:7 Md. R. 324) Regulation .19A amended effective May 26, 2025 (52:10 Md. R. 436); March 16, 2026 (53:5 Md. R. 244)