Rule 1301:18-4-01 | Cultivator and Processor Good Manufacturing Processes.
Each cultivator and processor shall establish, maintain, and comply with written policies and procedures for the safe, sanitary, and clean cultivation and manufacturing of cannabis at the licensed premises. Each cultivator and processor shall ensure all policies and procedures include the following:
(A) Personnel:
(1) Disease control. Any employee who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of cannabis, cannabis-contact surfaces, or cannabis-packaging materials becoming contaminated, is to be excluded from any operations which may be expected to result in such contamination until the condition is corrected, unless conditions such as open lesions, boils, and infected wounds are adequately covered (e.g., by an impermeable cover).
(a) Personnel are to be instructed to report such health conditions to their supervisors.
(2) Cleanliness. All employees working in direct contact with cannabis, cannabis-contact surfaces, and cannabis-packaging materials are to conform to hygienic practices while engaged in employment activities to the extent necessary to protect against allergen cross-contact and against contamination of cannabis. The methods for maintaining cleanliness include:
(a) Wearing outer garments suitable to the operation in a manner that protects against allergen cross-contact and against the contamination of cannabis, cannabis-contact surfaces, or cannabis-packaging materials.
(b) Maintaining adequate personal cleanliness
(c) Removing all unsecured jewelry and other objects that might fall into cannabis, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which cannabis is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the cannabis, cannabis-contact surfaces, or cannabis-packaging materials.
(d) Maintaining gloves, if they are used in cannabis handling, in an intact, clean, and sanitary condition.
(e) Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints.
(f) Storing clothing or other personal belongings in areas other than where cannabis is exposed or where equipment or utensils are washed.
(g) Confining the following to areas other than where cannabis may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco.
(h) Taking any other necessary precautions to protect against allergen cross-contact and against contamination of cannabis, cannabis-contact surfaces, or cannabis-packaging materials with microorganisms or foreign substances (including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin).
(3) Hand washing.
(a) Each employee is to clean their hands and the exposed portions their arms using a cleaning compound in a hand-washing sink that is appropriately equipped, at the following times:
(i) Immediately before working with cannabis plants;
(ii) Immediately before preparing or packaging cannabis, including, without limitation, working with exposed cannabis, cleaning equipment and utensils or unwrapped single-service and single-use articles;
(iii) After touching any bare human body parts other than their clean hands and exposed portions of arms, including, without limitation, surrogate prosthetic devices for hands and arms;
(iv) After using the toilet facilities;
(v) After coughing, sneezing, using a handkerchief or disposable tissue, using tobacco, eating, or drinking;
(vi) After handling soiled equipment or utensils;
(vii) During preparation or packaging of cannabis, as often as necessary to remove soil and contamination and to prevent cross- contamination when changing tasks;
(viii) Before donning gloves for working with cannabis; and
(ix) After engaging in other activities that contaminate the hands.
(b) Each employee is to use the following cleaning procedure in the order stated to clean their hands and the exposed portions of their arms, including, without limitation, surrogate prosthetic devices for hands and arms:
(i) Rinse under clean, running, warm water
(ii) Apply an amount of cleaning compound recommended by the manufacturer of the cleaning compound.
(iii) Rub together vigorously for at least fifteen seconds while:
(a) Paying particular attention to removing soil from underneath the fingernails during the cleaning procedure; and
(b) Creating friction on the surfaces of the hands and arms, fingertips and areas between the fingers
(c) Thoroughly rinse under clean, running warm water; and
(d) Immediately follow the cleaning procedure with thorough drying using a clean paper towel.
(B) Facility and grounds.
(1) Grounds. The grounds about the licensed premises under the control of the licensee are to be kept in a condition that will protect against the contamination of cannabis. The methods for adequate maintenance of grounds are to include:
(a) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the licensed premises that may constitute an attractant, breeding place, or harborage for pests.
(b) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where cannabis is exposed.
(c) Adequately draining areas that may contribute contamination to cannabis by seepage, foot-borne filth, or providing a breeding place for pests.
(d) Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where cannabis is exposed.
(e) If the licensed premises grounds are bordered by grounds not under the licensee's control and not maintained in the manner described in paragraphs (B)(1)(a) through (e) of this rule, care is to be exercised in the facility by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of cannabis contamination.
(2) Facility construction and design. The facility is to be suitable in size, construction, and design to facilitate maintenance and sanitary operations for cannabis-production purposes (i.e., cultivating, manufacturing, processing, packing, and holding). The facility is to:
(a) Provide adequate space for such placement of equipment and storage of materials as is necessary for maintenance, sanitary operations, and the production of safe cannabis.
(b) Reduce the potential for allergen cross-contact and for contamination of cannabis, cannabis-contact surfaces, or cannabis-packaging materials with microorganisms, chemicals, filth, and other extraneous material.
(i) The potential for allergen cross-contact and for contamination may be reduced by adequate cannabis safety controls and operating procedures or effective design, including the separation of operations in which allergen cross-contact and contamination are likely to occur, by one or more of the following means: location, time, partition, air flow systems, dust control systems, enclosed systems, or other effective means.
(c) Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate cannabis, cannabis-contact surfaces, or cannabis-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating cannabis, cannabis-contact surfaces, or cannabis-packaging materials with clothing or personal contact.
(d) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where cannabis is harvested, examined, manufactured, produced, processed, packed, tested, or held and where equipment or utensils are cleaned; and provide shatter-resistant light bulbs, fixtures, skylights, or other glass suspended over exposed cannabis in any step of preparation or otherwise protect against cannabis contamination in case of glass breakage.
(e) Provide adequate ventilation or control equipment to minimize dust, odors, and vapors (including steam and noxious fumes) in areas where they may cause allergen cross-contact or contaminate cannabis; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for allergen cross-contact and for contaminating cannabis, cannabis-packaging materials, and cannabis-contact surfaces.
(f) Provide, where necessary, adequate screening or other protection against pests.
(C) Sanitary Operations
(1) General maintenance. Buildings, fixtures, and other physical facilities of the licensed premises are to be maintained in a clean and sanitary condition and be kept in repair adequate to prevent cannabis from becoming adulterated.
(a) Cleaning and sanitizing of utensils and equipment are to be conducted in a manner that protects against allergen cross-contact and against contamination of cannabis, cannabis-contact surfaces, or cannabis-packaging materials.
(2) Substances used in cleaning and sanitizing; storage of toxic materials.
(a) Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures are to be free from undesirable microorganisms and safe and adequate under the conditions of use.
(i) Cleaning compounds and sanitizing agents are to be used in accordance with the labeling requirements.
(ii) Processors are to use food-safe sanitizers for all utensils and contact surfaces.
(b) Only the following toxic materials may be used or stored in a facility where cannabis is processed or exposed:
(i) Those necessary to maintain clean and sanitary conditions;
(ii) Those necessary for use in the facility's operations;
(iii) Those necessary for use in laboratory testing procedures; and
(iv) Those necessary for facility and equipment maintenance and operation.
(c) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals are to be identified, held, and stored in a manner that protects against contamination of cannabis, cannabis-contact surfaces, or cannabis-packaging materials.
(3) Pest control.Pests are not allowed in any area of a cannabis facility.
(a) ) Guard, guide, or pest-detecting dogs may be allowed in some areas of a facility if the presence of the dogs is unlikely to result in contamination of cannabis, cannabis-contact surfaces, or cannabis-packaging materials.
(b) Effective measures are to be taken to exclude pests from the cultivation, production, manufacturing, processing, testing, packing, and holding areas and to protect against the contamination of cannabis on the premises by pests.
(c) The use of pesticides to control pests in the facility is permitted only under precautions and restrictions that will protect against the contamination of cannabis, cannabis-contact surfaces, and cannabis-packaging materials.
(4) Sanitation of cannabis-contact surfaces. All cannabis-contact surfaces, including utensils and cannabis-contact surfaces of equipment, are to be cleaned as frequently as necessary to protect against allergen cross-contact and against contamination of cannabis.
(a) Cannabis-contact surfaces used for cultivating, producing, manufacturing, processing, testing, packing, or holding low-moisture cannabis are to be in a clean, dry, sanitary condition before use. When the surfaces are wet-cleaned, they are to be, when necessary, sanitized and thoroughly dried before subsequent use.
(b) In wet processing, when cleaning is necessary to protect against allergen cross-contact or the introduction of microorganisms into cannabis, all cannabis-contact surfaces are to be cleaned and sanitized before use and after any interruption during which the cannabis-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and cannabis-contact surfaces of the equipment must be cleaned and sanitized as necessary.
(c) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) are to be stored, handled, and disposed of in a manner that protects against allergen cross-contact and against contamination of cannabis, cannabis-contact surfaces, or cannabis-packaging materials.
(5) Non-cannabis-contact surfaces of equipment used in the operation of a cannabis facility are to be cleaned in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of cannabis, cannabis-contact surfaces, and cannabis-packaging materials.
(6) Cleaned and sanitized portable equipment with cannabis-contact surfaces and utensils are to be stored in a location and manner that protects cannabis-contact surfaces from allergen cross-contact and from contamination.
(D) Sanitary facilities and controls
(1) Each facility is to be equipped with adequate sanitary facilities and accommodations including:
(a) The water supply is to provide potable water that meets the standards prescribed in the Primary Drinking Water Regulations, 40 C.F.R. Part 141 and be adequate for the operations intended and derived from an adequate source.
(i) Any water that contacts cannabis, cannabis-contact surfaces, or cannabis-packaging materials is to be safe and of adequate sanitary quality.
(ii) All running water is to be a suitable temperature, and under pressure as needed, in all areas where required for the cultivation, manufacture, and processing of cannabis, for the cleaning of equipment, utensils, and cannabis-packaging materials, or for employee sanitary facilities.
(b) Plumbing is to be of adequate size and design and adequately installed and maintained to:
(i) Carry adequate quantities of water to required locations throughout the facility.
(ii) Properly convey sewage and liquid disposable waste from the facility.
(iii) Avoid constituting a source of contamination to cannabis, water supplies, equipment, or utensils or creating an unsanitary condition.
(iv) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.
(v) Provide that there is not backflow from, or cross-connection between, piping systems that discharge wastewater or sewage and piping systems that carry water for cannabis cultivation, production, or manufacturing.
(c) Sewage is to be disposed of into an adequate sewerage system or disposed of through other adequate means.
(d) Toilet facilities. Each facility is to provide employees with adequate, readily accessible toilet facilities.
(i) Toilet facilities are to be kept clean and cannot be a potential source of contamination of cannabis, cannabis-contact surfaces, or cannabis-packaging materials.
(e) Each facility where employees will have direct contact with cannabis, cannabis-contact surfaces, and cannabis-packaging materials are to contain a fully-stocked hand-washing sink limited to hand washing only with the following:
(i) Disposable, single-use paper towels in a mounted dispenser;
(ii) Hand washing soap contained in a dispenser; and
(iii) A trash can conveniently located near the sink.
(f) Waste disposal. In accordance with rule 1301:18-3-12 of the Administrative Code, waste must be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of cannabis, cannabis-contact surfaces, cannabis-packaging materials, water supplies, and ground surfaces.
(E) Equipment and utensils
(1) All cannabis not contained within packaging intended for direct customer sale is to be maintained in food grade containers.
(2) All facility equipment and utensils used in cultivating, producing, manufacturing, processing, testing, packing, or holding cannabis are to be so designed and of such material and workmanship as to be adequately cleanable, and adequately maintained to protect against allergen cross-contact and contamination.
(a) Equipment and utensils are to be designed, constructed, and used appropriately to avoid the adulteration of cannabis with lubricants, fuel, metal fragments, contaminated water, or any other contaminants.
(b) Equipment is to be installed so as to facilitate the cleaning and maintenance of the equipment and of adjacent spaces.
(c) Cannabis-contact surfaces are to be corrosion-resistant when in contact with cannabis.
(d) Cannabis-contact surfaces are to be made of nontoxic materials and designed to withstand the environment of their intended use and the action of cannabis, and, if applicable, cleaning compounds, sanitizing agents, and cleaning procedures.
(e) Cannabis-contact surfaces are to be maintained to protect cannabis from allergen cross-contact and from being contaminated by any source, including unlawful indirect cannabis additives.
(3) Seams on cannabis-contact surfaces are to be smoothly bonded or maintained so as to minimize accumulation of cannabis particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms and allergen cross-contact.
(4) Equipment that is in areas where cannabis is cultivated, manufactured, processed, tested, packed, or held and that does not come into contact with cannabis is to be so constructed that it can be kept in a clean and sanitary condition.
(5) Trimming, holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, is to be of a design and construction that enables them to be maintained in an appropriate clean and sanitary condition.
(6) Each freezer and cold storage compartment used to store and hold cannabis capable of supporting growth of microorganisms is to be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment.
(7) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in cannabis are to be accurate and precise and adequately maintained, and adequate in number for their designated uses.
(8) Compressed air or other gases mechanically introduced into cannabis or used to clean cannabis-contact surfaces or equipment are to be treated in such a way that cannabis is not contaminated with unlawful indirect cannabis additives.
(F) Processes and controls
(1) All operations in the cultivation, production, manufacturing, processing, testing, dispensing, packing, and holding of cannabis (including operations directed to receiving, inspecting, transporting, and segregating) are to be conducted in accordance with adequate sanitation principles.
(a) Appropriate quality control operations are to be employed to ensure that cannabis is suitable for human consumption and that cannabis-packaging materials are safe and suitable.
(b) Overall sanitation of the facility is to be under the supervision of one or more competent individuals assigned responsibility for this function.
(c) Adequate precautions are to be taken to ensure that production procedures do not contribute to allergen cross-contact and to contamination from any source.
(d) Chemical, microbial, or extraneous-material testing procedures are to be used where necessary to identify sanitation failures or possible allergen cross-contact and cannabis contamination.
(e) All cannabis that has become contaminated to the extent that it is adulterated must be rejected, or if appropriate, treated or processed to eliminate the contamination.
(2) Raw materials and other ingredients. Raw materials and other ingredients are to be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into cannabis and stored under conditions that will protect against allergen cross-contact and against contamination and minimize deterioration.
(a) Raw materials are to be washed or cleaned as necessary to remove soil or other contamination.
(b) Water used for washing, rinsing, or conveying cannabis are to be safe and of adequate sanitary quality.
(i) Water may be reused for washing, rinsing, or conveying cannabis if it does not cause allergen cross-contact or increase the level of contamination of the cannabis.
(c) Raw materials and other ingredients are to either not contain levels of microorganisms that may render the cannabis injurious to the health of humans, or otherwise treated during production and manufacturing operations so that they no longer contain levels that would cause the product to be adulterated.
(d) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins are to comply with FDA regulations for poisonous or deleterious substances before these raw materials or other ingredients are incorporated into finished cannabis.
(e) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material are to comply with applicable FDA regulations for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing cannabis.
(f) Raw materials, other ingredients, and rework are to be held in bulk, or in containers designed and constructed so as to protect against allergen cross-contact and against contamination and held at such temperature and relative humidity and in such a manner as to prevent the cannabis from becoming adulterated. Material scheduled for rework must be identified as such.
(g) Frozen raw materials and other ingredients are to be kept frozen. If thawing is required prior to use, it to be done in a manner that prevents the raw materials and other ingredients from becoming adulterated.
(h) Liquid or dry raw materials and other ingredients received and stored in bulk form are to be held in a manner that protects against allergen cross-contact and against contamination.
(i) Raw materials and other ingredients that are cannabis allergens, and rework that contains cannabis allergens, are to be identified and held in a manner that prevents allergen cross-contact.
(3) Manufacturing operations. Equipment and utensils and cannabis containers are to be maintained in an adequate condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment is to be taken apart for thorough cleaning.
(a) All cannabis cultivation, manufacturing, processing, packing, testing, and holding are to be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, allergen cross-contact, contamination of cannabis, and deterioration of cannabis.
(b) Cannabis that can support the rapid growth of undesirable microorganisms is to be held at temperatures that will prevent the cannabis from becoming adulterated during cultivation, production, manufacturing, processing, packing, testing, and holding.
(c) Measures such as sterilizing, irradiating, cooking, freezing, refrigerating, controlling pH, or controlling aw that are taken to destroy or prevent the growth of undesirable microorganisms are to be adequate under the conditions of manufacture, handling, and distribution to prevent cannabis from being adulterated.
(d) Work-in-process and rework is to be handled in a manner that protects against allergen cross-contact, contamination, and growth of undesirable microorganisms.
(e) Effective measures are to be taken to protect finished cannabis from allergen cross-contact and from contamination by raw materials, other ingredients, or refuse.
(i) When raw materials, other ingredients, or refuse are unprotected, they cannot be handled simultaneously in a receiving, loading, or shipping area if that handling could result in allergen cross-contact or contaminated cannabis.
(ii) During transportation, cannabis is to be protected against allergen cross-contact and against contamination as necessary.
(f) Equipment, containers, and utensils used to cultivate, process, manufacture, test, convey, hold, or store raw materials and other ingredients, work-in-process, rework, or other cannabis is to be constructed, handled, and maintained during manufacturing, processing, packing, and holding in a manner that protects against allergen cross-contact and against contamination.
(g) Adequate measures are to be taken to protect against the inclusion of metal or other extraneous material in cannabis.
(h) Cannabis, raw materials, and other ingredients that are adulterated are to be disposed of in a manner that protects against the contamination of other cannabis.
(i) Steps such as washing, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming is to be performed so as to protect cannabis against allergen cross-contact and against contamination.
(j) Cannabis is to be protected from contaminants that may drip, drain, or be drawn into the cannabis.
(k) Heat blanching, when required in the preparation of cannabis products capable of supporting microbial growth, is to be effected by heating the cannabis to the required temperature, holding it at this temperature for the necessary time, and then either rapidly cooling the cannabis or passing it to subsequent manufacturing without delay. Growth and contamination by thermophilic microorganisms in blanchers is to be minimized by the use of adequate operating temperatures and by periodic cleaning and sanitizing as necessary.
(l) Batters, breading, sauces, gravies, dressings, dipping solutions, and other similar preparations that are held and used repeatedly over time are to be treated or maintained in such a manner that they are protected against allergen cross-contact and against contamination, and minimizing the potential for the growth of undesirable microorganisms.
(m) Filling, assembling, packaging, and other operations are to be performed in such a way that the cannabis is protected against allergen cross-contact, contamination and growth of undesirable microorganisms.
(n) Food, such as dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies principally on the control of aw for preventing the growth of undesirable microorganisms is to be processed to and maintained at a safe moisture level.
(o) Cannabis that relies principally on the control of pH for preventing the growth of undesirable microorganisms is to be monitored and maintained at a pH of 4.6 or below.
(p) When ice is used in contact with cannabis, it is to be made from water that is safe and of adequate sanitary quality in accordance with this rule and used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part.
(G) Cannabis storage and distribution
(1) Storage and transportation of cannabis is to be under conditions that will protect against allergen cross-contact and against biological, chemical (including radiological), and physical contamination of cannabis, as well as against deterioration of the cannabis and the container.
(H) A cultivator or processor may request exemption of a specific mandate outlined under this rule so long as the following apply:
(1) The division issued the licensee a certificate of operation prior to the initial effective date of this rule; and
(2) The licensee demonstrates the following:
(a) The specific mandate would require a major modification of an immutable, structural aspect of the licensed premises; and
(b) All other factors outlined under rule 1301:18-9-06 of the Administrative Code.
Last updated January 1, 2026 at 4:38 AM
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