New Mexico Register / Volume XXXIII, Issue 19 / October 11,
2022
TITLE 16 OCCUPATIONAL AND PROFESSIONAL LICENSING
CHAPTER 8 COMMERICAL AND MEDICAL CANNABIS
PART 6 HEALTH AND SAFETY, FOOD AND PRODUCT SAFETY, ENVIRONMENTAL IMPACTS, AND NATURAL RESOURCES
16.8.6.1 ISSUING AGENCY: New Mexico Regulation and Licensing Department, Cannabis Control Division.
[16.8.6.1 NMAC – N, 10/11/2022]
16.8.6.2 SCOPE: This rule applies to all applicants for licensure pursuant to the Cannabis Regulation Act, the Lynn and Erin Compassionate Use Act or division rules, and where applicable, the general public.
[16.8.6.2 NMAC - N, 10/11/2022]
16.8.6.3 STATUTORY AUTHORITY: The requirements set forth herein are promulgated by the cannabis control division pursuant to the authority granted under the Cannabis Regulation Act and the licensing provisions of the Lynn and Erin Compassionate Use Act.
[16.8.6.3 NMAC - N, 10/11/2022]
16.8.6.4 DURATION: Permanent.
[16.8.6.4 NMAC - N, 10/11/2022]
16.8.6.5 EFFECTIVE DATE: October 11, 2022, unless a later date is cited at the end of a section.
[16.8.6.5 NMAC - N, 10/11/2022]
16.8.6.6 OBJECTIVE: The objective of Part 6 is to set forth standards related to health and safety, food and product safety, environmental impacts, and natural resources to ensure public health, safety, and well-being. Part 6 is not applicable to personal use of cannabis pursuant to the Cannabis Regulation Act or the Lynn and Erin Compassionate Use Act.
[16.8.6.6 NMAC - N, 10/11/2022]
16.8.6.7 DEFINITIONS:
[RESERVED]
16.8.6.8 PREREQUISITE AND RESPONSIBILITY FOR OPERATION:
A. Except as specified in Subsection F
of 16.8.6.7 NMAC, prior to the submission of a license application for a class
II, III, or IV cannabis manufacture license, each applicant or licensee engaged
in the manufacturing of edible or topical cannabis products
or edible or topical cannabis finished products shall provide to NMED a
certification that:
(1) the facility where the cannabis manufacturer operates, and
the manufacturing equipment used will be constructed and maintained in
accordance with the requirements of this part; and
(2) edible and topical
cannabis products and edible and topical finished products will be stored,
manufactured, packaged, repackaged, labeled, relabeled, tested, reworked, or
wasted in accordance with the requirements of this part.
B. A
certification shall include information specified in Subparagraphs (a) through
(i) of Paragraph (1) of Subsection A of 16.8.2.30
NMAC.
C. Any person signing a certification pursuant to this
section shall include the following signed statement: “I certify under penalty
of law that this document and all attachments were prepared under my direction
or supervision in accordance with a system designed to assure that qualified
personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons
who manage the system, or those persons directly responsible for gathering the
information, the information submitted is, to the best of my knowledge and
belief, true, accurate, and complete. I
am aware that there are significant penalties for submitting false information.”
D. NMED
shall provide confirmation of receipt to each applicant or licensee that
provides a certification.
E. Each
applicant or licensee shall provide the NMED confirmation to RLD as specified
in Paragraph (1) of Subsection A of 16.8.2.30 NMAC.
F. Certification
to NMED, as specified in Subsections A through E of 16.8.6.7 shall no longer be
required after December 31, 2022.
G. Class
II, III, or IV cannabis manufacturers that were licensed by RLD prior to the
effective date of 16.8.6 NMAC, and that are also engaged in manufacturing of
cannabis edible products or cannabis edible finished products, shall apply for
a food permit from NMED or a home rule municipality by January 1, 2023.
H. Except
as specified in Subsection F of 16.8.6.7 NMAC, class II, III, or IV cannabis
manufacturers that were not licensed by RLD prior to the effective date of
16.8.6 NMAC, and that are also engaged in manufacturing cannabis edible
products or cannabis edible finished products, shall provide a certification to
NMED as specified in Subsections A through E and apply for a food permit from
NMED or a home rule municipality as specified in G of 16.8.6.7 NMAC.
I. Beginning
April 1, 2023, Class II, III, or IV cannabis manufacturers that manufacture
cannabis edible products or cannabis edible finished products shall not operate
without a food permit from NMED or a home rule municipality.
[16.8.6.8 NMAC - N, 10/11/2022]
16.8.6.9 MANAGEMENT AND PERSONNEL:
A. Adoption of food code parts 2-1, 2-3
and 2-4 and section 2-103.11. Except as
otherwise provided, parts 2-1, 2-3 and 2-4 and section 2-103.11 of the 2017
United States food and drug administration model food code is hereby adopted
and incorporated in its entirety.
B. A licensee shall have written
procedures for employees to follow when responding to vomiting or diarrheal
events that involve the discharge of vomitus or fecal matter onto surfaces in
the edible cannabis manufacturing
facility. The procedures shall be
maintained onsite and address the specific actions employees must take to
minimize the spread of contamination and the exposure of employees, consumers,
food, and surfaces to vomitus or fecal matter.
C. Except as otherwise provided, the
licensee shall be the person in charge or shall designate a person in charge
and shall ensure that a person in charge is present at the cannabis
manufacturer facility during all
hours of operation.
D. If edible or topical cannabis
products or edible or topical cannabis finished products are manufactured as
part of a vertically integrated cannabis establishment or integrated cannabis
microbusiness that is the legal responsibility of the same licensee and that
are located on the same licensed premises, the licensee may designate a single
person in charge who is present on the licensed premises during all hours of
operation.
E. The person in charge shall have the
education, training, or experience necessary to supervise the production of
clean and safe edible or topical cannabis products or edible or topical
cannabis finished products and ensure the cannabis manufacturer remains in compliance with this part,
division rules, and the act at all times.
F. Personal care items on the premises
shall be stored in a manner to protect edible and topical cannabis products,
edible and topical cannabis finished products, other ingredients, equipment,
and utensils from contamination at all times.
G. A
licensee shall:
(1) immediately
contact the division to report an illness of an employee or conditional
employee as specified under Subsection A of this section;
(2) immediately
discontinue operations and notify the division if an imminent health hazard may
exist as specified in 16.8.6.13 NMAC;
[16.8.6.9 NMAC - N,
10/11/2022]
16.8.6.10 EDIBLE AND TOPICAL
CANNABIS MANUFACTURER REQUIREMENTS:
A. Adoption of 21
CFR 117. Except as otherwise
provided, Subpart F and the sections, specified in paragraphs 1-7 of this
subsection, of Subparts A and B of the United States code of federal
regulations, title 21, part 117 are hereby adopted and incorporated in their
entirety:
(1) 117.3 Definitions;
(2) 117.20 Plant and grounds;
(3) 117.35 Sanitary operations;
(4) 117.37
Sanitary facilities and controls;
(5) 117.40 Equipment and utensils;
(6) 117.80 Processes and controls; and
(7) 117.110 Defect action levels and
Subpart F.
B. Modifications. Except as otherwise provided, the following modifications
are made to the incorporated subparts of 21 CFR 117:
(1) 117.301: All records required by this part are subject
to all requirements of this subpart;
(2) 117.315(c): Offsite storage of records is permitted if
such records can be retrieved and provided onsite within 24 hours of request
for official review. Electronic records
are considered to be onsite if they are accessible from an onsite location; and
(3) 117.320: All records required by this part must be
made promptly available to the division for official review and copying upon
oral or written request.
C. Omissions. Except as otherwise provided, the following
omissions are made to the incorporated subparts of 21 CFR 117:
(1) 117.310;
(2) 117.315(d);
(3) 117.325;
(4) 117.335; and
(5) The following terms are omitted from
section 117.3 Definitions:
(a) Allergen;
(b) Food;
(c) Food-contact surfaces;
(d) Lot;
(e) Manufacturing/processing; and
(f) Packing.
D. Adoption of food code parts 4-5, 4-6 and
4-7. Except as otherwise provided, parts
4-5, 4-6, and 4-7 of the 2017 United States food and drug administration model
food code is hereby adopted and incorporated in its entirety.
(1) Food or cannabis product debris on equipment and utensils
shall be scraped over a waste disposal unit or garbage receptacle or shall be
removed in a warewashing machine with a prewash
cycle.
(2) If necessary, for effective cleaning, utensils and
equipment shall be pre-flushed, presoaked, or scrubbed with abrasives. Ethyl alcohol (ethanol) or isopropyl alcohol
(isopropanol) are acceptable for pre-flushing or presoaking.
F. Omissions. Except as otherwise provided, the following
omissions are made to the incorporated subparts of the 2017 United States food
and drug administration model food code:
(1) 4-502.12;
(2) 4-502.13(B);
(3) 4-502.14;
(4) 4-602.11(A)(1);
(5) 4-602.11(B);
(6) 4-602.11(D)(3); and
(7) 4-602.11(E)(2)-(3).
G. Cannabis
Product Ingredient Source.
(1) Ingredients shall be received from sources as specified in
7.6.2 NMAC.
(2) Cannabis products, ingredients, and edible or topical
cannabis finished products intended for human consumption shall be transported
under conditions that will protect against allergen cross-contact and against
biological, chemical (including radiological), and physical contamination
of the cannabis products, ingredients,
and cannabis finished products, as well as against deterioration of the
cannabis products, ingredients, and cannabis finished products and the
container in accordance with the New Mexico Food Service Sanitation Act and the
New Mexico Food Act.
H. The current 21 CFR 111 and United
States Federal Food, Drug, and Cosmetic Act, Title 21, Chapter 9 and 7.6.2 NMAC are hereby adopted as a technical reference and
interpretation guide.
[16.8.6.10 NMAC – N, 10/11/2022]
16.8.6.11 WATER
SUPPLY AND SEWAGE:
A. Drinking water shall be obtained from an
approved source that is:
(1) a public water system; or
(2) a non-public water system that is
constructed, maintained, and operated according to law.
B. A drinking water system shall be flushed and disinfected before being
placed in service after construction, repair, or modification and after an
emergency situation, such as a flood, that may introduce contaminants to the
system.
C. Except as specified under Subsection
D of this section:
(1) Water from a public water system
shall meet the construction and drinking water quality standards specified in
20.7.10 NMAC; and
(2) Water from a non-public water system
shall meet:
(a) the construction requirements and
drinking water quality standards of a non-community water system as specified
in 20.7.10 NMAC; and
(b) the drinking water source setback
requirements as specified in 20.7.3 NMAC.
D. A non-drinking water supply shall be
used only if its use is approved and shall be used only for nonculinary
purposes such as air conditioning, non-cannabis equipment cooling, and fire
protection.
E. Except when used as specified in
Subsection D of this section, water from a non-public water system shall meet
the sampling requirements of a non-community water system as specified in
20.7.10 NMAC.
F. The most recent sample report for
the non-public water system shall be retained on file in the cannabis
manufacturer facility or the report shall be maintained as specified by state
water quality regulations.
G. Water shall be received from the
source through the use of:
(1) an approved public water main; or
(2) one or more of the following that
shall be constructed, maintained, and operated according to law:
(a) Non-public water main, water pumps,
pipes, hoses, connections, and other appurtenances;
(b) Water transport vehicles; or
(c) Water containers.
H. Sewage shall be disposed of
according to LAW. Liquid waste systems
shall meet the requirements of 20.7.3 NMAC.
[16.8.6.11 NMAC - N,
10/11/2022]
16.8.6.12 EDIBLE
AND TOPICAL CANNABIS FINISHED PRODUCT TESTING:
A. Edible
and topical cannabis finished products shall meet the requirements specified in
division rules related to testing prior to being transported or transferred
from the licensed premises, distributed, sold or otherwise made available to
consumers.
B. Edible and topical cannabis
finished products that do not meet the requirements of Subsection A of this
section shall:
(1) be segregated;
(2) reworked, remediated or
reconditioned as specified in division rules related to testing; or
(3) destroyed, wasted, and disposed of in
accordance with the wastage requirements of the division.
[16.8.6.12 NMAC – N,
10/11/2022]
16.8.6.13 EDIBLE AND TOPICAL CANNABIS
FINISHED PRODUCT TESTING LABORATORIES: Testing required
by the division shall be conducted by a division-approved cannabis testing
laboratory that has no direct ownership or financial interest in the facility
for which the testing is being conducted.
[16.8.6.13 NMAC - N,
10/11/2022]
16.8.6.14 CEASING OPERATIONS AND REPORTING:
A. Except as specified in Subsections B
and C of this section, a licensee shall immediately discontinue operations if
an imminent health hazard may exist because of an emergency such as a fire,
flood, extended interruption of electrical or water service, sewage backup,
misuse of poisonous or toxic materials,
onset of an apparent foodborne or cannabis-borne illness outbreak, gross
insanitary occurrence or condition, or other circumstance that may endanger
public health, employees, or the environment.
B. A licensee need not discontinue
operations in an area of a cannabis manufacturer facility that is unaffected by
the imminent health hazard.
C. Considering the nature of the
potential hazard involved and the complexity of the corrective action needed,
the division may allow the licensee to continue operations in the event of an
extended interruption of electrical or water service if:
(1) a written emergency operating plan
has been approved by the division (NMED);
(2) immediate corrective action is taken
by the licensee to eliminate, prevent, or control any food safety risk and
imminent health hazard associated with the electrical or water service
interruption; and
(3) the division (NMED) is informed upon
implementation of the written emergency operating plan.
D. If operations are discontinued as
specified in Subsection A of this section or otherwise according to law, the
licensee shall obtain approval from the division (NMED) before resuming operations.
[16.8.6.14 NMAC - N, 10/11/2022]
16.8.6.15 SEVERABILITY: If any part or application of this rule is held to be invalid, the remainder or its application to other situations or persons shall not be affected. Any section of this rule legally severed shall not interfere with the remaining protections and duties provided by this rule.
[16.8.6.15 NMAC – N, 10/11/2022]
History of
16.8.6 NMAC: [RESERVED]