Current through Register Vol. 35, No. 18, September 24, 2024
The following are minimum requirements for the manufacture
of cannabis-derived products which shall apply to all manufacturers and
licensed non-profit producers that manufacture cannabis-derived
products:
A.
General
requirements: A licensed non-profit producer and a manufacturer shall
ensure the following:
(1) that all
manufacturing shall be done in premises that are in compliance with state and
local laws, including but not limited to zoning, occupancy, licensing, and
building codes;
(2) that the
manufacturing operation and all equipment, implements, and fixtures that are
used for the manufacture of cannabis derived products shall be used exclusively
for the manufacture of cannabis derived products and that food processing for
personal, staff, or the general public shall be prohibited;
(3) that all manufacturing is done indoors;
with the exception that compressed gas extraction may occur outdoors in
accordance with applicable standards of the New Mexico regulation and licensing
department;
(4) that all
manufacturing is conducted in a manner that does not allow cross-contamination
from chemical or biological hazards;
(5) that manufacturing does not occur at a
location that is within 300 feet of a school, church, or daycare center that
existed within the 300-foot area before the non-profit producer or manufacturer
became licensed to operate at the location;
(6) that all non-profit producer and
manufacturer staff involved in the handling, transportation, manufacture,
testing, or packaging of cannabis derived products must complete general food
handler safety training;
(7) that
any person who, by medical examination or supervisory observation, is shown to
have, or appears to have, an illness, open lesion, including a boil, sore, or
infected wound, or any other abnormal source of microbial contamination for
whom there is a reasonable possibility of contact with preparation surfaces for
medical cannabis or cannabis derived products, shall be excluded from any
operations which may be anticipated to result in such contamination until the
condition is corrected;
(8) that
hand-washing facilities are provided that are adequate, accessible, and
conveniently located, and that they are furnished with running water at a
suitable temperature; hand-washing facilities shall be located in indoor
production facilities, in restrooms, and wherever good sanitary practices
require employees to wash or sanitize their hands, and shall be stocked with
effective hand-cleaning and sanitizing preparations, and sanitary towel service
or suitable drying devices;
(9)
that all persons involved in preparing or handling medical cannabis or cannabis
derived products at the manufacturing operation conform to hygienic practices
while on duty, including:
(a) maintaining
adequate personal cleanliness;
(b)
washing hands thoroughly in an adequate hand-washing area before starting
0work, at any other time when the hands may have become soiled or contaminated,
and both before putting gloves on and after removal of gloves;
(c) refraining from preparing or handling
medical cannabis or cannabis derived products if the handler has or may have an
illness, open lesion, including boils, sores, or infected wounds, or any other
abnormal source of microbial contamination, until such condition is
corrected;
(d) complying with the
other requirements of this section.
(10) that there is sufficient space for
placement of equipment and storage of materials as is necessary for the
maintenance of sanitary operations for production of medical cannabis derived
products;
(11) that litter and
waste are properly removed, and the operating systems for waste disposal are
maintained in an adequate manner so that they do not constitute a source of
contamination in areas where medical cannabis or cannabis derived products are
exposed;
(12) that floors, walls,
and ceilings are constructed in such a manner that they are washable, wipeable,
and non-absorbent, and can be kept clean, and kept in good repair;
(13) that walls and ceilings remain free of
water damage, and that fiberglass and other insulation material not be
exposed;
(14) that there is
adequate safety-type lighting in all areas where medical cannabis or cannabis
derived products are processed or stored, and where equipment or utensils are
cleaned;
(15) that the manufacturer
provides adequate screening or other protection against the entry of pests;
rubbish shall be disposed of so as to minimize the development of odor,
minimize the potential for the waste becoming an attractant and harborage, or
breeding place for pests;
(16) that
building, fixtures, and other physical facilities where cannabis derived
products are manufactured are maintained in a sanitary condition;
(17) that all contact surfaces, including
utensils and equipment used for preparation of cannabis derived products are
cleaned and sanitized as frequently as necessary to protect against
contamination;
(18) that all
equipment and utensils used for preparation of cannabis derived products are
designed and of such material and workmanship as to be adequately cleanable,
and are properly maintained;
(19)
that only environmental protection agency (EPA) registered sanitizing agents
are used in manufacturing operations and that they are used in accordance with
labeled instructions;
(20) that
toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be
identified, held, and stored in a manner that protects against contamination of
medical cannabis or cannabis derived products;
(21) that any chemicals used for extraction
in the manufacturing process be intended for such usage, and that they be of
food or medical grade;
(22) that
the water supply is sufficient for the operations intended and is derived from
a source that is a regulated water system; private water supplies shall be from
a water source that is capable of providing a safe, potable, and adequate
supply of water to meet the manufacturing facility's needs;
(23) that plumbing shall be of adequate size
and design, adequately installed, and maintained to carry sufficient quantities
of water to required locations throughout the facility; and properly convey
sewage and liquid disposable waste from the facility;
(24) that there are no cross-connections
between the potable and waste water lines;
(25) that the manufacturer provide its
employees with adequate, readily accessible, on-site toilet facilities that are
maintained in a sanitary condition and good repair;
(26) that all operations in the receipt,
inspection, transport, segregation, preparation, manufacture, packaging, and
storage of medical cannabis or cannabis derived products are conducted in
accordance with adequate security and sanitation principles;
(27) that medical cannabis or cannabis
derived products that can support the rapid growth of undesirable
microorganisms are stored and transported in a manner that prevents the growth
of these microorganisms;
(28) that
storage and transportation of usable cannabis is accomplished under conditions
that will maintain security and protect medical cannabis or cannabis derived
products against physical, chemical, and microbial contamination as well as
against deterioration of the medical cannabis or cannabis derived product and
the container;
(29) that current
material safety data sheets are kept on the premises for all chemicals used,
including but not limited to cleaning compounds, sanitizing agents, and
pesticides;
(30) that extraction
for the purpose of manufacturing concentrates is conducted in a closed system
utilizing an oil extractor solvent such as N-butane or carbon dioxide or
utilizing ethyl alcohol;
(31) that
all containers used for storage or transport of usable cannabis are washable,
wipeable, and nonabsorbent;
(32)
that if alcohol is to be used for extraction, only food grade, non-denatured
ethyl alcohol is used for that purpose;
(33) that all weighting or measuring devices
that are used in the production, distribution, or manufacture of usable
cannabis be appropriately documented as having undergone certified registration
and calibration that is in accordance with applicable requirements of the New
Mexico department of agriculture;
(34) that the manufacture of a cannabis
derived product by a manufacturer from the cannabis material produced by a
personal production license holder is recorded in an electronic tracking system
specified by the department;
(35)
that the manufacturer or non-profit producer will prohibit its employees and
contractors from being under the influence of drugs or alcohol in the
workplace;
(36) that the department
is notified of any changes to the days or hours of business
operation;
(37) that staff who are
tasked with conducting compressed gas extraction activities be appropriately
trained in the of use of extraction equipment, as well as safety and emergency
procedures, by a qualified trainer, prior to beginning extraction
activities;
(38) that hemp, hemp
extract, and hemp derived products (other than hemp paper) are not combined in
any manner with usable cannabis that is intended to be sold or otherwise
distributed in the medical cannabis program; and
(39) that cannabis and cannabis derived
products that are kept in manufacturing areas at all times be clearly
segregated from hemp and hemp derived products.