Permissible Extractions

1. Mechanical extraction.
2. Chemical extraction using a nonvolatile solvent such as a nonhydrocarbon-based or other solvent such as water, vegetable glycerin, vegetable oils, animal fats, or food- grade glycerin. Nonhydrocarbon-based solvents shall be food grade.
3. Chemical extraction using a professional closed loop CO2 gas extraction system.
4. Chemical extraction using a volatile solvent.
5. Any other method authorized by the appropriate regulatory agency after submission of a detailed extraction method validating the method and any safety procedures.

Volatile Solvent Extractions

• All local and state laws specific to the production of compliant cannabis extracts.
• The extraction operation shall be approved by the local fire code official and shall be operated in accordance with all relevant state and local requirements and fire, safety, and building code requirements specified in:
  (1) National Fire Protection Association (NFPA) standards;
  (2) International Building Code (IBC);
  (3) International Fire Code (IFC); and
  (4) Other applicable standards including all applicable fire, safety, and building codes related to the processing, handling and storage of the applicable solvent or gas.
• All extractions shall be performed in a professional closed loop extraction system. The system shall be commercially manufactured and bear a permanently affixed and visible serial number. The system shall be certified by a licensed engineer that the system was commercially manufactured, safe for its intended use, and built to codes of recognized and generally accepted good engineering practices, such as:  
  (1) The American Society of Mechanical Engineers (ASME);
  (2) American National Standards Institute (ANSI);
  (3) Underwriters Laboratories (UL); or
  (4) The American Society for Testing and Materials (ASTM).  The certification document must contain the signature and stamp of a licensed professional engineer and the serial number of the extraction unit being certified.

Ethanol Extractions

• Ethanol used for extractions or for post-extraction processing shall be food-grade.
• The extraction operation shall be approved by the local fire code official and shall be operated in accordance with State Division of Occupational Health and Safety (OSHA) standards and any other relevant state and local requirements.

• Raw materials and other ingredients shall be inspected, segregated, or otherwise handled as necessary to ensure that they are clean and suitable for processing into cannabis products, and shall be stored under conditions that protect against allergen cross-contact and contamination, and in such a way as to minimize deterioration.
• Raw materials must be washed or cleaned as necessary to remove soils and other contaminates. Water used for washing, rinsing, or conveying cannabis product ingredients must be safe and of adequate sanitary quality.
• Raw materials and other ingredients shall not contain levels of microorganisms that render the cannabis product injurious to human health, or shall be pasteurized or otherwise treated during manufacturing so that they no longer contain levels of microorganisms that would cause the cannabis product to be adulterated.
• Raw materials and other ingredients shall be held in bulk, or in containers designed and constructed so as to protect against allergen cross-contact or contamination, and shall be held at such temperature and relative humidity and in such a manner as to prevent the cannabis products from becoming adulterated.  
• Frozen raw materials and other ingredients shall be kept frozen at a temperature no greater than zero (0) degrees Fahrenheit. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated.
• Raw materials and other ingredients that are food allergens shall be identified and held in a manner that prevents cross-contact with other raw materials or ingredients.

The following types of products shall not be sold as edible cannabis products:

• Alcoholic beverages defined as alcohol, spirits, liquor, wine, beer and every liquid or solid containing alcohol, spirits, wine or beer, and which contains one-half of 1 percent or more of alcohol by volume and which is fit for beverage purposes either alone or combined with other substances. For purposes of this section, “alcoholic beverage” does not include tinctures.
• Any product designed to appeal to minors or is attractive to children.
• Any product in the shape or form of a human, animal, insect or fruit.
• Any product containing any non-cannabinoid additive that would increase potency, toxicity, or addictive potential, or that would create an unsafe combination with other psychoactive substances. Prohibited additives include, but are not limited to, nicotine and caffeine. This prohibition shall not apply to products containing naturally-occurring caffeine, such as coffee, tea, or chocolate.
• Any cannabis product that must be held at or below 41 degrees Fahrenheit to keep it safe for human consumption, including, but not limited to, cream or custard-filled pies; pies or pastries which consist in whole or in part of milk or milk products, eggs, or synthetic fillings; or meat-filled pies or pastries. This prohibition shall not apply to juices or beverages that need to be held below 41 degrees Fahrenheit;
• Any low-acid cannabis product with a finished equilibrium pH greater than 4.6 and water activity greater than 0.85, packed in a hermetically sealed container in a reduced oxygen package (e.g. vacuum packed);
• Any juice that is not shelf-stable;
• Dairy products of any kind, except that butter purchased from a licensed milk products plant or retail location may be subsequently infused with cannabis and sold as a cannabis product;
• Any product that is manufactured by application of cannabinoid concentrate or extract to commercially available candy or snack food items without further processing of the product.
• Any cannabis product that the appropriate regulatory agency determines is easily confused with commercially available foods without cannabis.

Requirements for Edible Cannabis Products

• Edible Cannabis Products shall not contain more than ten (10) milligrams of THC per serving or the prevailing state and local regulation of the manufacturer.
• Edible cannabis products shall not contain more than one hundred (100) milligrams of THC per package or the prevailing state and local regulation of the manufacturer.
• Except for cannabis, cannabis concentrate, or terpenes, no product ingredient or component shall be used in the manufacture of an edible cannabis product unless that ingredient or component is permitted by the United States Food and Drug Administration for use in food or food manufacturing.
• Edible Cannabis Products that consist of more than a single serving shall either be:  
  (1) Scored, delineated,or otherwise marked to indicate one serving, or
  (2) Packaged in a manner such that a single serving is readily identifiable.
• Each serving of an edible cannabis product in a multi-serving package shall be homogenized to contain the same concentration of THC, within the variance established through state regulation.

Requirements for Topical Cannabis Products, Concentrates, and Other Cannabis Products

• A cannabis product that is not an Edible Cannabis Product and that is manufactured for the adult-use market shall not contain more than 1,000 mg of THC per package or the prevailing state and local regulation of the manufacturer.
• A cannabis product that is not an Edible Cannabis Product and that is manufactured for the medicinal market shall not contain more than 2,000 mg of THC per package or the prevailing state and local regulation of the manufacturer.
• Topical cannabis products shall only contain ingredients permitted for cosmetic manufacturing in accordance with Title 21, Code of Federal Regulations, Part 700, subpart B (section 700.11 et seq.).

Juice Processing

• Requirements of this section shall apply to manufacturers of cannabis-infused juice to be sold as either 100% juice or to be used as an ingredient in other products. The requirements of this section do not apply to manufacturers of infused beverages that use non-infused juice as an ingredient, provided that the juice was produced in accordance with United States Food and Drug Administration regulations.
• Manufacturers of juice shall include in the hazard analysis controls that will consistently produce, at minimum, a 5 log reduction in the pertinent microorganism. For purposes of this section, “pertinent microorganism” is the most resistant microorganism of public health significance that is likely to occur in the juice.
• A juice manufacturer that relies on treatments that do not come into direct contact with all parts of the juice to achieve the requirements of subsection (a) shall analyze the finished product for biotype I Escherichia coli in accordance with 21 CFR, section 120.25.

Each member shall establish and implement written procedures to ensure the following for all personnel:

• Disease control. Any individual who by medical examination or supervisory observation is shown to have, or appears to have, an illness, open lesion (such as boils, sores, or infected wounds), or any other source of microbial contamination presenting a reasonable threat of contamination to cannabis products, contact surfaces, or packaging materials, shall be excluded from any related manufacturing operations until their health condition is corrected. Open lesions, boils, and/or infected wounds shall be adequately covered (e.g., by an impermeable cover). Personnel shall be instructed to report such health conditions to their supervisors.
• Cleanliness. All individuals working in direct contact with cannabis products, cannabis product-contact surfaces, and cannabis product-packaging materials shall conform to hygienic practices to the extent necessary to protect against allergen cross-contact and contamination of cannabis products while on duty.

Grounds

Each member shall establish and implement written procedures to ensure that the grounds of the premises controlled by the licensee are kept in a condition that prevents the contamination of components and cannabis products. The methods for adequate maintenance of the grounds shall include at minimum:

• The proper storage of equipment, removal of litter and waste, and cutting of weeds or grass within the immediate vicinity of the cannabis manufacturing facility so that the premises shall not constitute an attractant, breeding place, or harborage for pests.
• The proper maintenance of roads, yards, and parking lots so that these areas shall not constitute a source of contamination in areas where cannabis products are handled or transported.
• The provision of adequate draining areas in order to prevent contamination by seepage, foot-borne filth, or the breeding of pests due to unsanitary conditions.
• The provision and maintenance of waste treatment systems so as to prevent contamination in areas where cannabis products may be exposed to such a system’s waste or waste by-products.

Storage

• Maintain separate areas for storage of marijuana that is outdated, damaged, deteriorated, mislabeled or contaminated or whose packaging has been breached.
• Storage areas shall be maintained in a clean and orderly condition and free from infestation by insects, rodents, birds and pests.
• Storage areas shall be locked and limited in access to only those employees who are over 21 years of age and have completed training.
• Storage and transportation of finished products shall be under conditions that will protect them against physical, chemical and microbial contamination and deterioration.
• Vehicles transporting marijuana or marijuana products must be equipped with functioning heating and air conditioning systems appropriate for maintaining correct temperatures for storage.
• Marijuana and marijuana products must be transported in a secure, locked storage compartment.

Sanitary Operations

The licensee shall establish and implement written sanitary operation procedures to ensure the following:

• Buildings, fixtures, and other physical facilities on the premises are maintained in a clean and sanitary condition and are kept in good repair so as to prevent cannabis products from becoming adulterated.
• The cleaning and sanitation of utensils and equipment is conducted in a manner that protects against allergen cross-contact and contamination of cannabis products or product components, cannabis product-contact surfaces, or cannabis product-packaging materials.
• Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures are free from undesirable microorganisms and are safe and adequate under their conditions of use.
• Toxic cleaning compounds, sanitizing agents, and pesticide chemicals are identified, held, and stored in a manner that protects against contamination of product components, cannabis products, cannabis product-contact surfaces, or cannabis product-packaging materials.
• Effective measures are taken to exclude pests from the cannabis manufacturing facility in all areas where cannabis components and/or products may be at risk of contamination by pests. The use of pesticides to control pests in the cannabis manufacturing facility is permitted only under precautions and restrictions that protect against the contamination of cannabis products, cannabis product-contact surfaces, and cannabis product-packaging materials.
• All cannabis product-contact surfaces including utensils and equipment are cleaned as frequently as necessary to protect against allergen cross-contact and contamination of cannabis products.
• Cannabis product-contact surfaces used for manufacturing, processing, packing or holding low-moisture cannabis products shall be maintained in a clean, dry, and sanitary condition before use. When such surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use.
• When cleaning is necessary to protect against allergen cross-contact or the introduction of microorganisms into cannabis products during wet processing, all cannabis product-contact surfaces shall be cleaned and sanitized before use and after any interruption during which cannabis product-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, their surfaces shall be cleaned and sanitized as necessary.
• The non-cannabis product-contact surfaces of equipment used in the cannabis manufacturing facility are cleaned in a manner and as frequently as necessary to protect against allergen cross-contact and contamination of cannabis products, cannabis product-contact surfaces, and cannabis product-packaging materials.

Equipment and Utensils

• All cannabis manufacturing equipment and utensils used in manufacturing cannabis products shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be adequately maintained to protect against allergen cross-contact and contamination.
• Cannabis product-contact surfaces shall be corrosion-resistant when in contact with cannabis products.
• Cannabis product-contact surfaces shall be maintained to protect cannabis products from allergen cross-contact and from contamination by any source, including prohibited additives.
• Cannabis product-contact surfaces shall be maintained to protect cannabis products from allergen cross-contact and from contamination by any source, including prohibited additives.
• Each freezer and cold storage compartment used to store and hold cannabis products, ingredients, or components capable of supporting growth of microorganisms shall be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment.
• Compressed air or other gases mechanically introduced into cannabis products or used to clean cannabis product-contact surfaces or equipment shall be treated in such a way that cannabis products shall not be contaminated with prohibited additives.

• Appropriate quality control operations shall be employed to ensure that cannabis products are suitable for human consumption or use, and that cannabis product-packaging materials are safe and suitable.
• Overall sanitation of the premises shall be under the supervision of one or more competent individuals assigned responsibility for this function.
• Adequate precautions shall be taken to ensure that production procedures do not contribute to allergen cross-contact and to contamination from any source.
• Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible allergen cross-contact and cannabis product contamination.
• Any cannabis product that has become contaminated to the extent that it is adulterated shall be rejected, or if appropriate, treated or processed to eliminate the contamination, as determined by a qualified individual.

Each member shall establish and implement written manufacturing operation procedures to ensure the following:

• Adulterated cannabis products, raw materials, or other ingredients shall be either:  
  (1) Disposed of in a manner that protects against the contamination of other cannabis products or ingredients; or  
  (2) Reprocessed, if appropriate, using a method that has been proven to be effective and subsequently reexamined and found to be unadulterated.
• Steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect cannabis products against allergen cross-contact and contamination. Cannabis products shall be protected from contaminants that may drip, drain, or be drawn into the cannabis product.
• When required in the preparation of cannabis products capable of supporting microbial growth, heat blanching shall be affected by heating the cannabis product to the required temperature, holding that temperature for the required amount of time, and then either rapidly cooling the cannabis product or passing it to subsequent manufacturing without delay. Growth and contamination by thermophilic microorganisms in blanchers shall be minimized by the use of adequate operating temperatures and by periodic cleaning and sanitization as necessary.
• Batters, breading, sauces, gravies, dressings, dipping solutions, and other similar preparations that are held and used repeatedly over time shall be treated or maintained in such a manner that they are protected against allergen cross-contact and contamination, and in a manner that minimizes the potential growth of undesirable organisms.
• Filling, assembling, packaging, and related operations shall be performed in such a way that the cannabis product is protected against allergen cross-contact, contamination and growth of undesirable microorganisms.
• Cannabis products that principally rely on the control of water activity (aw) for preventing the growth of undesirable microorganisms (such as dry mixes, nuts, intermediate moisture cannabis products, and dehydrated cannabis products) shall be processed and maintained at a safe moisture level. For purposes of this section “safe moisture level” is a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing.  
  
  The safe moisture level for an edible cannabis product is related to its aw. An aw will be considered safe for a manufactured cannabis product if adequate data is available to demonstrate that at or below the given aw the manufactured cannabis product will not support the growth of undesirable microorganisms.
• When ice is used in contact with cannabis products, the ice shall be made from water that is safe and of adequate sanitary quality, and shall be used only if it has been manufactured in accordance with current good manufacturing practices established by the U.S. Food and Drug Administration.

• The identification of potential hazards,including:  
  (1) Biological hazards, including microbiological hazards;  
  (2) Chemical hazards, including radiological hazards, pesticide(s) contamination, solvent or other residue, natural toxins, decomposition, unapproved additives, or food allergens; and/or  
  (3) Physical hazards, such as stone, glass, metal fragments, hair or insects.
• The evaluation of the hazards identified in order to assess the severity of any illness or injury that may occur as a result of a given hazard, and the probability that the hazard will occur in the absence of preventive controls.
• The hazard evaluation shall consider the effect of the following on the safety of the finished cannabis product for the intended consumer: 
  (1) The sanitation conditions of the manufacturing premises;
  (2) The product formulation;
  (3) The design, function and condition of the manufacturing facility and its equipment;
  (4) The raw material, ingredients and other components used in a given cannabis product; (5) Product transportation and transfer practices;
  (6) The manufacturing and processing procedures;
  (7) The packaging and labeling activities;
  (8) The storage of components and/or the finished cannabis product;
  (9) The intended or reasonably foreseeable use of the finished cannabis product;
  (10) Any other relevant factors.

• Each member shall establish and implement written procedures to ensure that each piece of equipment and machinery is suitable for its intended use prior to operation.
• The licensee shall maintain verification records for all equipment and machinery, which contain at minimum:
  (1) Documentation of successful verification of each piece of equipment and machinery, dated and signed by the person conducting the verification.
  (2) Documentation of successful re-verifications of each piece of equipment and machinery upon any modification to the equipment or machinery, intended use, or standard operating procedure.
  (3) A log detailing and documenting the verification and re-verification of all equipment and machinery in operation on the licensed premises.

Each member shall establish and implement written procedures to ensure that:

1. A qualified individual shall review and investigate all product complaints to determine whether such complaints involve a possible failure of a cannabis product to meet any of its specifications;
2. Quality control personnel shall review and approve decisions determining whether to investigate a product complaint and shall review and approve the findings and follow up action(s) of any investigation performed;
3. Pursuant to subdivisions (a) and (b) in this section, any review and/or investigative activities by qualified individuals and quality control personnel shall extend to all relevant batches and records.
4. Quality control personnel shall maintain written records for every product complaint and subsequent investigation, if any. The records shall include:
   (1) The name and description of the cannabis product;
   (2) The batch number or UID of the cannabis product, if available;
   (3) The date the complaint was received and the name, address, and/or telephone number of the complainant, if available;
   (4) The nature of the complaint including, if known, how the product was used;
   (5) The reply to the complainant, if any; and
   (6) Any findings of the investigation and/or follow-up action taken when an investigation is performed.
5. For purposes of this section, “product complaint” means any communication that contains any allegation, written, electronic, or oral, expressing concern, for any reason, with the quality of a cannabis product that could be related to the manufacturing practices. Examples of product complaints may include but are not limited to: foul odor, off taste, illness or injury, disintegration time, color variation, foreign material in a cannabis product container, improper packaging, mislabeling, cannabis products that contain incorrect concentration of cannabinoids, or cannabis products contain a wrong ingredient, or any form of contaminant.

Recalls

Each member shall establish and implement written procedures for recalling cannabis products manufactured by the licensee that are determined to be misbranded or adulterated. These procedures shall include:

• Factors which necessitate a recall;
• Personnel responsible for implementing the recall procedures; and
• Notification protocols, including:  
  (1) A mechanism to notify all customers that have, or could have, obtained the product, including communication and outreach via media, as necessary and appropriate;
  (2) A mechanism to notify any licensees that supplied or received the recalled product;
  (3) Instructions to the general public and/or other licensees for the return and/or destruction of recalled product.
  (4) Procedures for the collection and destruction of any recalled product. Such procedures shall meet the following requirements: 1) All recalled products that are intended to be destroyed shall be quarantined for a minimum of 72 hours. The licensee shall affix to there called products any bills of lading, shipping manifests, or other similar documents with product information and weight, and shall notify the appropriate regulatory agency of the quarantine. The product held in quarantine shall be subject to auditing by the appropriate regulatory agency. 
  (5) A licensee shall dispose of chemical, dangerous, or hazardous waste in a manner consistent with federal, state, and local laws. This requirement shall include but is not limited to recalled products containing or consisting of pesticide or other agricultural chemicals, certain solvents or other chemicals used in the production of manufactured cannabis batches, and cannabis soaked in a flammable solvent for the purpose of producing manufactured cannabis batches.  
  (6) A licensee shall not dispose of recalled product in an unsecured area or waste receptacle that is not in the possession and/or control of the licensee.

For recalled cannabis products, the licensee shall enter the following details into the track and trace database: the weight of the product, reason for destruction, and the date the quarantine period will begin.

Failed Product Batches

• Failed product batches shall be destroyed unless remediation or reprocessing is approved by the state agency.
• Remediation or reprocessing of failed product batches or the use of harvest batches that have failed any laboratory test shall comply with any requirements and procedures established by the state appropriate regulatory agency through regulation, in addition to the requirements of this chapter.
• Edible Cannabis Products that fail laboratory testing requirements shall not be re-mediated or reprocessed and shall be destroyed. If any Edible Cannabis Product that has failed laboratory testing is re-mediated, reprocessed, or otherwise mixed with another batch of cannabis product, such action shall render the final cannabis product adulterated, regardless of the defect level of the final cannabis product.
• Not withstanding subsection (e), a cannabis product that is determined through laboratory testing to be labeled with an incorrect amount of THC per package or per serving may be relabeled with the correct information in accordance with a corrective action plan approved by the appropriate regulatory agency.
• Prior to any remediation or reprocessing of a failed product batch or the use of a failed harvest batch, the licensee shall submit a corrective action plan to the appropriate regulatory agency to include, at minimum, a description of how the product or harvest batch will be re-mediated such that the product or any product produced therefrom will meet all laboratory testing and quality assurance requirements. A failed product or harvest batch shall not be re-mediated or reprocessed by a licensee unless the appropriate regulatory agency has approved the licensee’s corrective action plan. Remediation or reprocessing of Edible Cannabis Products shall not be approved.
• Any remediation or reprocessing of a product batch that has failed laboratory testing or quality assurance review or the use of a failed harvest batch by a licensee shall be documented in the manufacturing records. All re-mediated product batches and products produced therefrom shall be tested and undergo quality assurance review in accordance with the requirements established by the appropriate regulatory agency prior to retail sale.

1. A licensee shall dispose of all waste in accordance with applicable state and local laws and regulations. It is the responsibility of the licensee to properly evaluate waste to determine if it should be designated a hazardous waste.
2. Waste containing cannabis or cannabis products shall be entered into a track-and-trace system.