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/E, 12/02/2021]
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/E, 12/02/2021]
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/E, 12/02/2021]
16.8.6.4 DURATION: Permanent.
[16.8.6.4 NMAC - N/E, 12/02/2021]
16.8.6.5 EFFECTIVE DATE: 12/02/2021, unless a later date is cited at the end of a section.
[16.8.6.5 NMAC - N/E, 12/02/2021]
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/E, 12/02/2021]
16.8.6.7 PREREQUISITE AND RESPONSIBILITY FOR OPERATION:
A. 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.
[16.8.6.7 NMAC - N/E, 12/02/2021]
16.8.6.8 OPERATIONAL PLANS:
(1) A
licensee shall prepare a written operational plan containing the following
information, as applicable, for each edible or topical cannabis product or edible
or topical cannabis finished product to be manufactured, labeled, relabeled,
packaged, or repackaged:
(a) planned
source of cannabis products and ingredients;
(b) names
of the ingredient(s);
(c) the
final product pH;
(d) the
final product water activity (Aw);
(e) names
of preservative(s);
(f) the
type of packaging to be used that complies with all requirements of section
16.8.3.13 of this part and whether the packaging is integral to product
stability;
(g) the
intended distribution of the product;
(h) if
the product is to be distributed at ambient, refrigerated or
frozen
temperature;
(i) the expected shelf life during
distribution, retail storage, and in the hands of the end user;
(j) how the product should be prepared
for consumption;
(k) what mishandling of the product might
occur in the merchandising channels or in the hands of the end user;
(l) the proposed recall plan, meeting
the requirements of 16.8.2.11 NMAC;
(m) the complete operational procedure for
product formulation, including:
(i) a
written, detailed description of the intended manufacturing process, including
method of infusion;
(ii) a
flow chart illustrating the manufacturing process; and
(iii) identification of critical control points.
(n) written good manufacturing practices (GMPs);
(o) other
policies and procedures related to the safe and sanitary operation of the
cannabis manufacturer;
(p) proposed
product labels that comply with all requirements of section 16.8.3.14 of this part;
(q) proposed record keeping and chain of
custody systems;
(r) a description of the batch/lot ID
coding system;
(s) proposed
pest control plan; and
(t) procedures
for remedial measures to bring cannabis products into compliance with division
standards; destruction, wastage, or disposal of a tested batch of cannabis
products if the testing samples from the tested batch indicate noncompliance
with applicable health and safety standards; and destruction, wastage, and
disposal of recalled cannabis products.
(2) Prior to adding new edible or topical
cannabis products or edible or topical cannabis finished products, or changing
the stated process for any existing product in the product line, a licensee
shall:
(a) for a new product, prepare a written
operational plan as specified in Section 9 of this part; and
(b) for an existing product for which a
change will be made in the manufacturing process, update the existing
operational plan.
(3) A licensee shall have an edible
cannabis finished product operational procedure approved by a process authority
to verify all critical factors of public health significance are addressed when
the product is determined to require a product assessment as determined by
table A or table B as follows:
Table A. Interaction of pH and aw for control of spores in FOOD
heat-treated to destroy vegetative cells and subsequently packaged
aw values |
pH: 4.6 or less |
pH: > 4.6 - 5.6 |
pH: > 5.6 |
<0.92 |
non-TCS food* |
non-TCS food |
non-TCS food |
> 0.92 - 0.95 |
non-TCS food |
non-TCS food |
PA** |
> 0.95 |
non-TCS food |
PA |
PA |
* TCS food means Time/Temperature
Control for Safety food
** PA means Product Assessment required
Table B. Interaction of pH and aw
for control of vegetative cells and spores in food
not heat-treated or heat-treated but not packaged
aw values |
pH: < 4.2 |
pH: 4.2 - 4.6 |
pH: > 4.6 - 5.0 |
pH: > 5.0 |
< 0.88 |
non-TCS
food* |
Non-TCS
food |
non-TCS
food |
non-TCS
food |
0.88 – 0.90 |
non-TCS food |
non-TCS food |
non-TCS food |
PA** |
> 0.90 – 0.92 |
non-TCS food |
non-TCS food |
PA |
PA |
> 0.92 |
non-TCS food |
PA |
PA |
PA |
* TCS food means time/temperature control for safety food
** PA means Product Assessment required
(4) The
licensee shall maintain current operational plans on the licensed premises during
all hours of operation and shall, upon request, make them available for review
by the division.
[16.8.6.8 NMAC - N/E, 12/02/2021]
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:
(a) immediately
contact the division to report an illness of an employee or conditional employee
as specified under Subsection A of this section;
(b) immediately
discontinue operations and notify the division if an imminent health hazard may
exist as specified in 16.8.3.17 NMAC;
[16.8.6.9 NMAC - N/E, 12/02/2021]
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.
E. Modifications. Except as otherwise provided, the following
modifications are made to the incorporated subparts of the 2017 United States
food and drug administration model food code:
(1) 4-603.12 Precleaning.
(a) 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.
(b) 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/E, 12/02/2021]
16.8.6.11 WATER
SUPPLY:
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.
[16.8.6.11 NMAC - N/E, 12/02/2021]
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/E, 12/02/2021]
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/E, 12/02/2021]
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;
(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 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 before resuming operations.
[16.8.6.14 NMAC - N/E, 12/02/2021]
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.
[16.8.6.16 NMAC – N/E, 12/02/2021]
History
of 16.8.6 NMAC: [RESERVED]