Chapter 11. Cannabis Processor Operations

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.

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.

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.

Entrance to an area where cannabis is processed, tested, packaged, or stored; and

Area where cannabis is processed, packaged, or stored.

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.

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.

Every 15 agents; and

Any fraction of 15 agents.

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.

A processor may acquire hemp, as defined in Agriculture Article, §14-101, Annotated Code of Maryland, from a person licensed to produce hemp by:

Any product derived from hemp shall comply with:

A licensed processor shall:

That is outdated, damaged, deteriorated, misbranded, or adulterated; or

Whose containers or packages have been improperly or accidentally opened.

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;

Cleaning of equipment;

The maintenance of equipment; and

The calibration of equipment; and

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.

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:

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:

If using carbon dioxide gas extraction, ensure:

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.

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.

Ensure product potency and purity; and

Provide support for expiration dating.

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.

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:

If applicable, update and implement standard operating procedures needed to ensure passing samples in the future.

Conduct further investigation; and

Implement additional procedures to prevent future contamination.

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’s premises; or

A facility under the legal control of the processor that meets:

Violates or fails to meet the requirements of this chapter; or

Fraudulently or deceptively attempts to obtain a permit.

Cannabis approved, licensed, and regulated by the Administration; or

Food ingredients regulated by an approving authority.

Application of heat, pressure, or other energy or matter that renders a food ingredient free of:

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.

“Critical item” means a safety requirement that if violated requires:

“Critical item” includes the following requirements:

Flavoring;

Food coloring; and

Preservatives.

Food or food ingredients; or

Cannabis.

“Potentially hazardous edible cannabis product” means an edible cannabis product that requires temperature control because the product is in a form capable of supporting:

“Potentially hazardous edible cannabis product” does not include products with a water activity (aw) value of 0.85 or less.

“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:

“Potentially hazardous ingredient” does not include an ingredient with a:

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;

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.

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.

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.

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.

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:

Ingredients or edible cannabis products are stored, processed, packaged, or labeled; or

Cookware or equipment is washed or stored.

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.

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.

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.

Delivery is not damaged or contaminated; or

Damaged or contaminated item is recorded in the receiving log.

Above the floors; and

Away from the walls; and

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.

Be maintained at or below 40°F; and

Have thermometers that are easily readable and accurate to plus or minus 2°F.

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.

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:

Be maintained at or below 0°F; and

Have thermometers that are easily readable and accurate to plus or minus 2°F.

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.

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:

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.

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.

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.

Food grade;

Approved for use in food processing areas; or

Designed to prevent any contact with any ingredient or edible cannabis product.

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.

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.

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.

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:

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.

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:

If cleaned and sanitized by pressurized cleaning-in-place system, readily accessible to the cleaning and sanitizing solutions without disassembly.

Ensure proper sanitation throughout the premises;

Are available to each agent in a form the agent understands; and

Are approved by the Administration.

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.

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.

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.

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:

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 the agent has any disease caused by:

If the agent has an:

If the agent is experiencing:

Ingredients;

Edible cannabis products;

Packaging and labeling materials; or

Cookware; and

Within 90 days of commencing employment at the premises; and

Every 3 years during employment; and

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.

Identifying and tracking the processor’s stock of cannabis in the seed-to-sale tracking system; and

Monthly physical inventory;

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;

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;

Preventing contamination;

Investigating decontaminating after presumptive positive pathogen detection; and

Remediation steps and resulting environmental analysis.

Sharing equipment and production materials; and

Maintaining independent and unique security and video surveillance control.