N.H. Admin. Code § He-C 402.16

Current through Register No. 45, November 7, 2024

Section He-C 402.16 - Production of Cannabis-Infused Products

(a) Except for registered qualifying patients or designated caregivers, subject to the limitations in He-C 401.18, only a registered ATC shall be permitted to produce CIP.

(b) An ATC which chooses to produce CIP shall do so in accordance with this section.

(c) CIP shall not be considered food and CIP production facilities shall not be considered food service establishments for the purpose of food service licensure under RSA 143.

(d) Production of CIP shall take place in a designated and separate limited access area of the registered premises.

(e) All edible CIP shall be prepared, handled, and stored in compliance with the sanitation requirements in He-P 2309.03, Sanitary Production and Distribution of Food, Food Processing Plant Standards.

(f) All ingredients of edible CIP shall be of food-grade quality.

(g) An ATC shall provide adequate refrigeration for perishable CIP that will be consumed.

(h) An ATC shall ensure that its production processes are designed so that the cannabinoid content of any edible CIP is homogenous.

(i) Edible CIP shall be individually packaged at the point of preparation except that smaller items may be packaged into larger quantities in a single wrapped package provided that the packaging meets the requirements of He-C 402.19(b) (1) .

(j) An ATC that chooses to produce cannabis concentrate shall be subject to the following:

(1) The following shall be permitted categories of cannabis concentrate:

a. Water-based cannabis concentrate;

b. Food-based cannabis concentrate;

c. Carbon dioxide (CO₂) -based cannabis concentrate; and

d. Solvent-based cannabis concentrate, using only the following solvents:

1. Acetone;

2. Butane;

3. Ethanol;

4. Heptane;

5. Isopropanol; and

6. Propane;

(2) The use of any solvent not listed in (1) d. above shall be expressly prohibited;

(3) An ATC that engages in the production of cannabis concentrate, regardless of the method of extraction or category of cannabis concentrate being produced, shall:

a. Ensure that the space in which any cannabis concentrate is to be produced is a fully enclosed room and clearly designated on the current diagram of the registered premises;

b. Ensure that the written standard operating procedure for each method used to produce a cannabis concentrate at the ATC includes step-by-step instructions on how to safely and properly conduct all aspects of the process;

c. Establish written quality control procedures designed to maximize safety and minimize potential product contamination;

d. Establish written emergency procedures to be followed in case of a fire, chemical spill, or other emergency; and

e. Provide, document, and verify comprehensive training for all ATC agents involved in the cannabis concentrate production process to include:

1. All standard operating procedures for each method of cannabis concentrate production used at that ATC;

2. The ATC's quality control procedures;

3. The ATC's emergency procedures;

4. The proper use of any necessary safety or sanitation equipment;

5. The hazards presented by all solvents or other ingredients or chemicals used within the ATC as described in the material safety data sheet for each solvent, ingredient, or chemical;

6. Clear instructions on the safe use of all equipment involved in each process and in accordance with manufacturer's instructions, where applicable; and

7. Any additional periodic cleaning required to comply with all applicable sanitation and safety rules;

(4) An ATC that engages in the production of water-based or food-based cannabis concentrate shall:

a. Meet the requirements of (e) above;

b. Ensure that all equipment, counters, and surfaces used in the production of cannabis concentrate are thoroughly cleaned after the completion of each batch of cannabis concentrate;

c. Ensure that any room in which dry ice is stored or used in processing cannabis concentrate is well ventilated to prevent the accumulation of dangerous levels of CO₂;

d. Ensure that the necessary safety or sanitation equipment, including personal protective equipment, is provided and properly used by all agents involved in the process;

e. Ensure that, if used, only food-grade propylene glycol or glycerin is use d in the production of food-based cannabis concentrate; and

f. Comply with (5) below related to the production of solvent-based cannabis concentrate if a pressurized system is used in the production process; and

(5) An ATC that engages in the production of solvent-based cannabis concentrate shall:

a. Comply with all state fire and building codes, including but not limited to the national electric code, all local ordinances, and with He-C 402.33(j) -(l) for the cannabis concentrate production area(s);

b. Obtain a material safety data sheet for each solvent or other chemical used or stored in the cannabis concentrate production area and keep them in a book that is readily accessible to all agents working in the cannabis concentrate production area and is readily accessible outside the cannabis concentrate production area as well;

c. Determine and post the maximum amount of all solvents and/or flammable chemicals that are permitted both in the storage and work areas of the cannabis concentrate production area in accordance with Saf-C 6000, the state fire code, as adopted by the commissioner of the department of safety under RSA 153, and as amended pursuant to RSA 153:5, I, by the state fire marshal with the board of fire control;

d. Ensure that all solvent-based extractions using flammable solvents meet the following requirements:

1. Such extractions shall be performed under:

(i) A static free fume hood; or

(ii) An electrostatic discharge safe, electrostatic dissipative, or static resistant certified fume hood for use for a class IB flammable liquid such as ethanol or isopropyl alcohol;

2. The hood in 1. above shall be certified and inspected, at least annually, in accordance with the manufacturer's instructions, to meet manufacturer's stated operational requirements; and

3. Written documentation of the certification and inspection in 2. above shall be made available to the department upon request;

e. Install throughout the registered premises an approved, supervised, automatic sprinkler system;

f. Install throughout the registered premises 110 Volt carbon monoxide detectors and a fire alarm system:

1. Where initiation of the fire alarm system shall be by manual means in accordance with section 9.6.2 of NFPA 101, as incorporated in He-C 402.05(c) (12) a.4., and by means of any required sprinkler system waterflow alarms, detection devices, or detection systems; and

2. Which automatically notifies occupants in accordance with section 9.6.3 of NFPA 101, as incorporated in He-C 402.05(c) (12) a.4.;

g. Have portable fire extinguishers, appropriate for the area and use, in accordance with section 9.7.4.1 of NFPA 101, as incorporated in He-C 402.05(c) (12) a.4.;

h. Ensure that all equipment, counters, and surfaces used in the production process are food-grade and shall not react adversely with any of the solvents to be used in the ATC;

i. Ensure that the room in which the cannabis concentrate is produced has a properly functioning emergency eye-wash station;

j. Ensure that all solvents used in cannabis concentrate production are food grade or at least 99% pure;

k. Ensure that every batch of cannabis concentrate is tested for residual solvents which, except for ethanol and isopropanol, shall not exceed 500 parts per million per gram;

l. For ethanol and isopropanol, if residual solvents exceed 500 parts per million per gram, add a warning to the product label stating the amount of residual solvent, in parts per million per gram, contained in the product; and

m. Not use denatured alcohol in any part of the production process.

(k) A complete list of solvents and chemicals used in the production of any cannabis concentrate shall be made available to the department or a qualifying patient or designated caregiver upon request.

(l) No chemical listed in He-C 402.34 shall be used in any way in the production of CIP.

N.H. Admin. Code § He-C 402.16

Adopted byVolume XXXIV Number 50, Filed December 11, 2014, Proposed by #10731, Effective 11/25/2014.

Amended by Volume XXXV Number 45, Filed November 12, 2015, Proposed by #10961, Effective 10/23/2015, Expires 10/23/2025.

Amended by Volume XXXVIII Number 45, Filed November 8, 2018, Proposed by #12653, Effective 11/1/2018, Expires 11/1/2028.