CHAPTER 44:90:07

CANNABIS PRODUCT MANUFACTURING FACILITIES

Section

44:90:07:01        Manufacturing practices.

44:90:07:02        Work environment.

44:90:07:03        Cannabis product nonusable.

44:90:07:04        Prohibited manufacturing activities.

44:90:07:05        Extraction -- Approved operating procedures.

44:90:07:06        Generally safe concentration methods.

44:90:07:07        Potentially hazardous extraction methods.

44:90:07:08        Extraction using inherently hazardous substances.

44:90:07:09        Edible cannabis products.

    44:90:07:01 Manufacturing practices. A cannabis product manufacturing facility shall follow standard operating procedures to ensure workplace, environmental, and product safety:

    (1)  Ensuring that all equipment and surfaces that come into contact with cannabis or other ingredients are food grade and nonreactive;

    (2)  Maintaining all counters and surface areas in a manner that reduces the potential for development of microbials, molds, mildew, fungi, and other contaminants;

    (3)  Providing adequate refrigeration for ingredients and products during manufacture, storage, or transport;

    (4)  Ensuring that all electrical equipment is listed by a nationally recognized testing laboratory or inspected annually by an engineer licensed pursuant to SDCL chapter 36-18A; and

    (5)  Storing all chemicals in a safe manner.

    Source: 48 SDR 40, effective October 5, 2021.

    General Authority: SDCL 34-20G-72(5)(d)(e)(h).

    Law Implemented: SDCL 34-20G-72(5).

    44:90:07:02.  Work environment. As applicable, all agents of a cannabis product manufacturing facility shall:

    (1)  Work in an environment with proper ventilation, controlling all sources of ignition where a flammable atmosphere is or may be present;

    (2)  Use proper eye protection, respiratory protection, and gloves;

    (3)  Use only water that is potable and ice that is made from potable water; and

    (4)  Undergo safety training on fire prevention and safe operation of equipment used for manufacturing.

    Source: 48 SDR 40, effective October 5, 2021.

    General Authority: SDCL 34-20G-72(5)(d)(e)(h).

    Law Implemented: SDCL 34-20G-72(5).

    44:90:07:03.  Cannabis product nonusable. A cannabis product is nonusable if it contains:

    (1)  For an inhalable cannabis product:

            (a)  A level of any contaminant listed in § 44:90:05:10 at or in excess of the corresponding action level specified in that section; or

            (b)  Residual solvents other than glycerin, propylene glycol, or cooking fats at or in excess of the following action level:

    (2)  For any other cannabis product:

            (a)  A level of residual pesticides, mycotoxins, or microbials listed in § 44:90:05:10 at or in excess of the corresponding action level specified in that section; or

            (b)  Residual solvents other than ethanol, glycerin, propylene glycol, or cooking fats at or in excess of the action level:

            (c)  Heavy metals at or in excess of the action level:

    Source: 48 SDR 40, effective October 5, 2021.

    General Authority: SDCL 34-20G-72(5)(d)(e)(h).

    Law Implemented: SDCL 34-20G-72(5).

    44:90:07:04.  Prohibited manufacturing activities. A cannabis product manufacturing facility may not:

    (1)  Manufacture a product in the distinct shape of human, animal, creature, vehicle, fruit, cartoon character, toy, emoji, or other artwork likely or intended to appeal to anyone under twenty-one years of age;

    (2)  Manufacture a cannabis product by adding or infusing cannabis into a commercially available, noncannabis end product;

    (3)  Manufacture any edible cannabis product, except a tincture, oil, or capsule, which has more than fifty milligrams of tetrahydrocannabinol (THC) per serving;

    (4)  Package in a marketing layer an edible cannabis product, except a tincture or oil, or capsule containing oil with more than five hundred milligrams of total THC;

    (5)  Manufacture any cannabis product except:

            (a)  Vaporizer products;

            (b)  Concentrated cannabis;

            (c)  Cannabis tinctures, oils, or capsules containing oil;

            (d)  Cannabis beverages;

            (e)  Other edible cannabis products; or

            (f)  Topical cannabis products;

    (6)  Manufacture any product intended for ophthalmic, otic, rectal, or vaginal administration;

    (7)  Manufacture any cannabis product intended for inhalation using or containing polyethylene glycol, vitamin E acetate, or medium chain triglyceride oil;

    (8)  Manufacture a product using cannabis or concentrated cannabis that has not passed any test required by the department;

    (9)  Manufacture cannabis products intended for non-human consumption;

    (10)  Manufacture products that do not contain cannabis on the same premises as cannabis products; or

    (11)  Extract cannabis using pressurized canned flammable fuel, handheld torch devices, refillable cigarette lighters, or similar consumer products.

    Source: 48 SDR 40, effective October 5, 2021; 50 SDR 62, effective November 27, 2023.

    General Authority: SDCL 34-20G-72(4)(e)(h).

    Law Implemented: SDCL 34-20G-72(4).

    44:90:07:05.  Extraction -- Approved operating procedures. A cannabis product manufacturing facility shall conform with the standard operating procedures for extraction methods described in its operating procedures and may not extract cannabis using any other methods without prior written approval by the department.

    A cannabis product manufacturing facility performing extraction may be subject to inspection by the state fire marshal, local fire department, building inspector, or code enforcement officer to confirm that no health or safety concerns are present, and that the facility complies with all applicable safety standards contained in local ordinance, SDCL chapter 11-10, article 61:15, and chapter 20:44:22.

    Source: 48 SDR 40, effective October 5, 2021.

    General Authority: SDCL 34-20G-72(5)(e)(h).

    Law Implemented: SDCL 34-20G-72(5).

    44:90:07:06.  Generally safe concentration methods. The following methods of preparing concentrated cannabis are permissible if listed in the establishment’s operating procedures on file with the department:

    (1)  Mechanical concentration using:

            (a)  Potable water and ice made from potable water;

            (b)  Dry screening or sieving;

            (c)  Cryogenic or subzero processing not involving a solvent; and

            (d)  Pressure and temperature.

    (2)  Infusion of cannabis in food grade fats or synthetic food additives using:

            (a)  Propylene glycol;

            (b)  Glycerin; or

            (c)  Butter, olive oil, or other typical cooking fats.

    Source: 48 SDR 40, effective October 5, 2021.

    General Authority: SDCL 34-20G-72(5)(e)(h).

    Law Implemented: SDCL 34-20G-72(5).

    44:90:07:07.  Potentially hazardous extraction methods. The department shall permit extraction using the following substances, if 99 percent or greater in purity and if the department deems storage, preparation, electrical, gas monitoring, fire suppression, and exhaust systems methods to be adequate:

    (1)  Carbon dioxide;

    (2)  Another liquid chemical, compressed gas, or commercial product that has a flashpoint above 100 degrees Fahrenheit; or

    (3)  Ethanol or solutions of ethanol and water.

    Source: 48 SDR 40, effective October 5, 2021.

    General Authority: SDCL 34-20G-72(5)(e)(h).

    Law Implemented: SDCL 34-20G-72(5).

    44:90:07:08.  Extraction using inherently hazardous substances. Before performing extraction using an inherently hazardous substance, the establishment must have prior physical inspection and written approval by an engineer licensed pursuant to SDCL chapter 36-18A that the establishment’s storage, preparation, electrical, gas monitoring, fire suppression, and exhaust systems are adequate for the extraction methods and substances used.

    Any extraction method using inherently hazardous substances must be listed in the operating procedures on file with the department and use a substance of ninety-nine percent or greater purity. The resulting extract must not exceed residual limits for the substance established by the department as part of testing requirements.

    The following solvents may be used in approved inherently hazardous extraction:

    (1)  Butane;

    (2)  Propane;

    (3)  Acetone;

    (4)  Heptane; or

    (5)  Pentane.

    The use of any inherently hazardous substance other than butane, propane, acetone, heptane, or pentane requires written prior approval of the department, upon documentation of the safety and efficacy of the selected method. All flammable gas must be stored and handled in accordance with all applicable safety standards contained in local ordinance, SDCL chapter 11-10, article 61:15, and chapter 20:44:22.

    Source: 48 SDR 40, effective October 5, 2021; 49 SDR 47, effective November 22, 2022.

    General Authority: SDCL 34-20G-72(5)(e)(h).

    Law Implemented: SDCL 34-20G-72(5).

    44:90:07:09.  Edible cannabis products. A cannabis product manufacturing facility that has declared edible cannabis products as part of its approved operating procedures shall:

    (1)  Obtain a South Dakota food service establishment license, pursuant to SDCL chapter 34-18, covering ongoing activities at the location identified in the operating procedures;

    (2)  Employ a Certified Food Service Manager meeting the requirements of § 44:02:07:03;

    (3)  Comply with all applicable standards of chapter 44:02:07, and the city or county in which the establishment is located.

    Source: 48 SDR 40, effective October 5, 2021.

    General Authority: SDCL 34-20G-72(5)(e)(h).

    Law Implemented: SDCL 34-20G-72(5).

    Cross-Reference: Person in charge, 44:02:07:03.