935 CMR, § 500.105 - General Operational Requirements for Marijuana Establishments
(1)
Written Operating Procedures. Every Marijuana
Establishment shall have and follow a set of detailed written operating
procedures. If the Marijuana Establishment has an additional location, it shall
develop and follow a set of such operating procedures for that facility. A CMO
shall have written operating procedures that comply with both
935
CMR 500.105(1) and
501.105(1):
Written Operating Procedures, and may do so by having two sets
of written operating procedures applicable to each medical-use and adult-use
operations or having one set of written operating procedures, provided it
complies with both medical-use and adult-use requirements. Operating procedures
shall include, but need not be limited to, the following:
(a) Security measures in compliance with
935
CMR 500.110;
(b) Employee security policies, including
personal safety and crime prevention techniques;
(c) A description of the Marijuana
Establishment's hours of operation and after-hours contact information, which
shall be provided to the Commission, made available to Law Enforcement
Authorities on request, and updated pursuant to
935 CMR
500.000;
(d) Storage and waste disposal of Marijuana
in compliance with
935
CMR 500.105(11) and
(12);
(e) Description of the various strains of
Marijuana to be cultivated, Processed or sold, as applicable, and the form(s)
in which Marijuana will be sold;
(f) Price list for Marijuana and Marijuana
Products and any other available products, and alternate price lists for
patients with documented Verified Financial Hardship, as defined in
935
CMR 501.002: Verified Financial
Hardship, as required by
935
CMR 501.105(1)(f);
(g) Procedures to ensure accurate
recordkeeping, including inventory protocols for Transfer and inventory in
compliance with
935
CMR 500.105(8) and
(9);
(h) Plans for quality control, including
product testing for contaminants in compliance with
935
CMR 500.160;
(i) A staffing plan and staffing records in
compliance with
935
CMR 500.105(9)(d);
(j) Emergency procedures, including a
disaster plan with procedures to be followed in case of fire or other
emergencies;
(k) Alcohol, smoke,
and drug-free workplace policies;
(l) A plan describing how Confidential
Information and other records required to be maintained confidentially will be
maintained;
(m) A policy for the
immediate dismissal of any Marijuana Establishment Agent who has:
1. Diverted Marijuana, which shall be
reported to Law Enforcement Authorities and to the Commission;
2. Engaged in unsafe practices with regard to
operation of the Marijuana Establishment, which shall be reported to the
Commission; or
3. Been convicted or
entered a guilty plea, plea of nolo contendere, or admission
to sufficient facts of a drug offense involving distribution to a minor in the
Commonwealth, or a like violation of the laws of any Other
Jurisdiction.
(n) A list
of all board of directors, members and Executives of a Marijuana Establishment,
and Members, if any, of the Licensee shall be made available on request by any
individual. This requirement may be fulfilled by placing this required
information on the Marijuana Establishment's website;
(o) Policies and procedure for the handling
of cash on Marijuana Establishment Premises including, but not limited to,
storage, collection frequency, and transport to financial institution(s), to be
available on inspection.
(p)
Policies and procedures to prevent the diversion of Marijuana to individuals
younger than 21 years old;
(q)
Policies and procedures for energy efficiency and conservation that shall
include:
1. Identification of potential
energy use reduction opportunities (including, but not limited to, natural
lighting, heat recovery ventilation and energy efficiency measures), and a plan
for implementation of such opportunities;
2. Consideration of opportunities for
renewable energy generation including, where applicable, submission of building
plans showing where energy generators could be placed on the site, and an
explanation of why the identified opportunities were not pursued, if
applicable;
3. Strategies to reduce
electric demand (such as lighting schedules, active load management and energy
storage); and
4. Engagement with
energy efficiency programs offered pursuant to M.G.L. c. 25, § 21, or
through municipal lighting plants.
(r) Policies and procedures to promote
workplace safety consistent with the standards set forth under the Occupational
Safety and Health Act of 1970,
29
U.S.C. §
651, et seq.,
including the general duty clause under
29 U.S.C. §
654, whereby each employer:
1. shall furnish to each of its employees
employment and a place of employment which are free from recognized hazards
that are causing or are likely to cause death or serious physical harm to its
employees;
2. shall comply with
occupational safety and health standards promulgated under this act. Each
employee shall comply with occupational safety and health standards and all
rules, regulations, and orders issued pursuant to
29
U.S.C. §
651, et seq.,
which are applicable to the employee's own actions and conduct. All current and
updated regulations and references at 29 CFR Parts 1903, 1904, 1910, 1915,
1917, 1918, 1926, 1928 and 1977 are incorporated by reference, and applicable
to all places of employment covered by
935 CMR
500.000.
All current and updated regulations and references at 29 CFR Parts 1903, 1904, 1910, 1915, 1917, 1918, 1926, 1928, and 1977 are incorporated by reference, and applicable to all places of employment covered by 935 CMR 500.000.
(2)
Marijuana Establishment Agent
Training.
(a) Marijuana
Establishments, including Independent Testing Laboratories, shall ensure that
all Marijuana Establishment Agents complete minimum training requirements prior
to performing job functions.
1. At a minimum,
Marijuana Establishment Agents shall receive a total of eight hours of training
annually. The eight-hour total training requirement shall be tailored to the
roles and responsibilities of the job function of each Marijuana Establishment
Agent.
2. A minimum of four hours
of training shall be from Responsible Vendor Training Program courses
established under 935 CMR 500.105(2)(b). Any additional RVT hours over the
four-hour RVT requirement may count toward the eight-hour total training
requirement.
3. Non-RVT training
may be conducted in-house by the Marijuana Establishment or by a third-party
vendor engaged by the Marijuana Establishment. Basic on-the-job training
Marijuana Establishments provide in the ordinary course of business may be
counted toward the eight-hour total training requirement.
4. Agents responsible for tracking and
entering product into the Seed-to-sale SOR shall receive training in a form and
manner determined by the Commission. At a minimum, staff shall receive eight
hours of on-going training annually.
5. Marijuana Establishments shall maintain
records of compliance with all training requirements noted above. Such records
shall be maintained for four years and Marijuana Establishments shall make such
records available for inspection on request.
6. An individual who is both a Marijuana
Establishment Agent and MTC Agent at a CMO location shall receive the training
required for each license under which the agent is registered including,
without limitation, with respect to patient privacy and confidentiality
requirements, which may result in instances that would require such an agent to
participate in more than eight hours of training.
(b)
Responsible Vendor
Training.
1. All current
Marijuana Establishment Agents, including Laboratory Agents, involved in the
handling or sale of Marijuana for adult use at the time of licensure or renewal
of licensure, as applicable, shall have attended and successfully completed a
Responsible Vendor Training Program to be designated a "Responsible Vendor".
a. Marijuana Establishment Agents shall first
take the Basic Core Curriculum.
b.
On completing the Basic Core Curriculum, a Marijuana Establishment Agent is
eligible to take the Advanced Core Curriculum.
c.
Exception for Administrative
Employees. Marijuana Establishment Agents who serve as
administrative employees and do not handle or sell Marijuana are exempt from
the four-hour RVT requirement, but may take a Responsible Vendor Training
Program course on a voluntary basis as part of fulfilling the eight-hour total
training requirement.
2.
Once a Marijuana Establishment is designated a Responsible Vendor, all
Marijuana Establishment Agents employed by the Marijuana Establishment that are
involved in the handling or sale of Marijuana for adult use shall successfully
complete the Basic Core Curriculum within 90 days of hire.
3. After successful completion of the Basic
Core Curriculum, each Marijuana Establishment Agent involved in the handling or
sale of Marijuana for adult use shall fulfill the four-hour RVT requirement
every year thereafter for the Marijuana Establishment to maintain designation
as a Responsible Vendor. Failure to maintain Responsible Vendor status is
grounds for action by the Commission.
4.
Responsible Vendor Trainer
Certification.
a. No owner,
manager or employee of a Responsible Vendor Trainer may be a Person Or Entity
Having Direct Or Indirect Ownership or Control of a Marijuana
Establishment.
b. Responsible
Vendor Trainers shall submit their program materials to the Commission prior to
offering courses, every two years following for Commission certification of the
Responsible Vendor Trainer and Responsible Vendor Training Program curriculum,
and on request. The process for certification will be in a form and manner
determined by the Commission.
c.
Responsible Vendor Training Program courses shall consist of at least two hours
of instruction time.
d. Except as
provided in 935 CMR 500.105(2)(b)4.e., Responsible Vendor Training Program
courses shall be taught in a real-time, interactive, virtual or in-person
classroom setting in which the instructor is able to verify the identification
of each individual attending the program and certify completion of the program
by the individual.
e. Responsible
Vendor Training Program courses may be presented in a virtual format that is
not taught in a real-time, provided that the Responsible Vendor Trainer, as
part of its application for certification, can demonstrate means:
i. To verify the identification of each
trainee participating in the program course and certify completion by the
individual;
ii. To track trainees'
time needed to complete the course training;
iii. To allow for the trainees to ask
questions of the Responsible Vendor Trainer, for example, by email, virtual
discussion board, or group/class discussion; and
iv. To evaluate each trainee's proficiency
with course material.
f.
Responsible Vendor Trainers shall seek certification for each Basic Core
Curriculum and Advanced Core Curriculum. Applications for Advanced Core
Curriculum certification will be open on or before July 1, 2022.
g. Responsible Vendor Trainers shall maintain
its training records at its principal place of business for four
years.
h. Responsible Vendor
Trainers shall make the records available for inspection by the Commission and
any other applicable licensing authority on request during normal business
hours.
i. Responsible Vendor
Trainers shall provide to the appropriate Marijuana Establishment and Marijuana
Establishment Agent written documentation of attendance and successful
evaluation of proficiency, such as passage of a test on the knowledge of the
required curriculum for each attendee.
j. Trainees who can speak and write English
fluently shall successfully demonstrate proficiency, such as passing a written
test with a score of 70% or better.
k. Marijuana Establishment Agents who cannot
speak or write English may be offered a verbal evaluation or test, provided
that the same questions are given as are on the written test and the results of
the verbal test are documented with a passing score of 70% or better.
l. Responsible Vendor Trainers shall solicit
effectiveness evaluations from Marijuana Establishment Agents who have
completed their program(s).
5.
Basic Core
Curriculum. The Basic Core Curriculum shall cover the following
subject matter:
a. Marijuana's effect on the
human body, including:
i. Scientifically
based evidence on the physical and mental health effects based on the type of
Marijuana Product;
ii. The amount
of time to feel impairment;
iii.
Visible signs of impairment; and
iv. Recognizing the signs of
impairment.
b. Diversion
prevention and prevention of sales to minors, including best
practices.
c. Compliance with all
tracking requirements.
d.
Acceptable forms of identification. Training shall include:
i. How to check identification;
ii. Spotting and confiscating fraudulent
identification;
iii. Patient
registration cards currently and validly issued by the Commission;
iv. Common mistakes made in identification
verification.
v. Prohibited
purchases and practices, including purchases by persons younger than 21 years
of age in violation of M.G.L. c. 94G, § 13.
e. Other key state laws and rules affecting
Marijuana Establishment Agents, which shall include:
i. Conduct of Marijuana Establishment
Agents;
ii. Permitting inspections
by state and local licensing and enforcement authorities;
iii. Local and state licensing and
enforcement, including registration and license sanctions;
iv. Incident and notification
requirements;
v. Administrative,
civil, and criminal liability;
vi.
Health and safety standards, including waste disposal;
vii. Patrons prohibited from bringing
Marijuana and Marijuana Products onto licensed premises;
viii. Permitted hours of sale;
ix. Licensee responsibilities for activities
occurring within licensed premises;
x. Maintenance of records, including
confidentiality and privacy; and
f. Such other areas of training determined by
the Commission to be included in a Responsible Vendor Training
Program.
6.
Advanced Core Curriculum.
a. Each Advanced Core Curriculum class shall
be approved by the Commission prior to being offered. The curriculum shall
build on the knowledge, skills, and practices covered in the Basic Core
Curriculum.
b. An Advanced Core
Curriculum class shall include standard and best practices in one or more of
the following areas
i. Cultivation;
ii. Product Manufacturing;
iii. Retail;
iv. Transportation;
v. Social Consumption;
vi. Laboratory Science;
vii. Energy and Environmental Best
Practices;
viii. Social Justice and
Economically Reparative Practices;
ix. Implicit Bias and Diversity
Training;
x. Worker
Safety;
xi. Food Safety and
Sanitation;
xii. Confidentiality
and Privacy;
xiii. In depth
coverage of any topic(s) taught in the Basic Core Curriculum; or
xiv. Such other topic as the Commission may
approve in its sole discretion.
7.
Delivery Core
Curriculum. In addition to the Basic Core Curriculum, all
Marijuana Establishment Agents acting as delivery employees of a Delivery
Licensee or a Marijuana Establishment with a Delivery Endorsement shall have
attended and successfully completed Delivery Core Curriculum prior to making a
delivery, which shall, to the extent not covered in Basic Core Training
include, without limitation, training on:
a.
Safely conducting deliveries;
b.
Safe cash handling practices;
c.
Strategies for de-escalating potentially dangerous situations;
d. Securing product following any instance of
diversion, theft or loss of Finished Marijuana Products pursuant to
935 CMR
500.110(1)(m);
e. Collecting and communicating information
to assist in investigations;
f.
Procedures for checking identification;
g. Indications of impairment;
h. Notification to Consumers of use of
mandatory recording devices; and
i.
Such other areas of training determined by the Commission to be included in a
Responsible Vendor Training Program.
(3)
Requirements for the Handling
of Marijuana.
(a) A Marijuana
Establishment authorized to Process Marijuana shall do so in a safe and
sanitary manner. A Marijuana Establishment shall Process the leaves and flowers
of the female Marijuana plant only, which shall be:
1. Well cured and free of seeds and
stems;
2. Free of dirt, sand,
debris, and other foreign matter;
3. Free of contamination by mold, rot, other
fungus, pests and bacterial diseases and satisfying the sanitation requirements
in
105 CMR 500.000, and if
applicable,
105 CMR 590.000:
State Sanitary Code Chapter X - Minimum Sanitation Standards for Food
Establishments;
4.
Prepared and handled on food-grade stainless steel tables with no contact with
Licensees' or Marijuana Establishment Agents' bare hands; and
5. Packaged in a secure
area.
(b) All Marijuana
Establishments, including those that develop, Repackage, or Process non-Edible
Marijuana Products, shall comply with the following sanitary requirements:
1. Any Marijuana Establishment Agent whose
job includes contact with Marijuana or non-Edible Marijuana Products, including
cultivation, production, or packaging, is subject to the requirements for food
handlers specified in
105 CMR 300.000:
Reportable Diseases, Surveillance, and Isolation and Quarantine
Requirements;
2. Any
Marijuana Establishment Agent working in direct contact with preparation of
Marijuana or non-Edible Marijuana Products shall conform to sanitary practices
while on duty, including:
a. Maintaining
adequate personal cleanliness; and
b. Washing hands thoroughly in an adequate
hand-washing area before starting work, and at any other time when hands may
have become soiled or contaminated.
3. Hand-washing facilities shall be adequate
and convenient and shall be furnished with running water at a suitable
temperature. Hand-washing facilities shall be located in the Marijuana
Establishment in Production Areas and where good sanitary practices require
Employees to wash and sanitize their hands, and shall provide effective
hand-cleaning and sanitizing preparations and sanitary towel service or
suitable drying devices;
4. There
shall be sufficient space for placement of equipment and storage of materials
as is necessary for the maintenance of sanitary operations;
5. Litter and waste shall be properly
removed, disposed of so as to minimize the development of odor and minimize the
potential for the waste attracting and harboring pests. The operating systems
for waste disposal shall be maintained in an adequate manner pursuant to 935
CMR 500.105(12);
6. Floors, walls,
and ceilings shall be constructed in such a manner that they may be adequately
kept clean and in good repair;
7.
There shall be adequate safety lighting in all Processing and storage areas, as
well as areas where equipment or utensils are cleaned;
8. Buildings, fixtures, and other physical
facilities shall be maintained in a sanitary condition;
9. All contact surfaces, including utensils
and equipment, shall be maintained in a clean and sanitary condition. Such
surfaces shall be cleaned and sanitized as frequently as necessary to protect
against contamination, using a sanitizing agent registered by the U.S.
Environmental Protection Agency (EPA), in accordance with labeled instructions.
Equipment and utensils shall be so designed and of such material and
workmanship as to be adequately cleanable;
10. All toxic items shall be identified,
held, and stored in a manner that protects against contamination of Marijuana
Products. Toxic items may not be stored in an area containing products used in
the cultivation of Marijuana. The Commission may require a Marijuana
Establishment to demonstrate the intended and actual use of any toxic items
found on the Premises;
11. A
Marijuana Establishment's water supply shall be sufficient for necessary
operations. Any private water source shall be capable of providing a safe,
potable, and adequate supply of water to meet the Marijuana Establishment's
needs;
12. Plumbing shall be of
adequate size and design, and adequately installed and maintained to carry
sufficient quantities of water to required locations throughout the Marijuana
Establishment. Plumbing shall properly convey sewage and liquid disposable
waste from the Marijuana Establishment. There shall be no cross-connections
between the potable and wastewater lines;
13. A Marijuana Establishment shall provide
its employees with adequate, readily accessible toilet facilities that are
maintained in a sanitary condition and in good repair;
14. Products that can support the rapid
growth of undesirable microorganisms shall be held in a manner that prevents
the growth of these microorganisms;
15. Storage and transportation of finished
products shall be under conditions that will protect them against physical,
chemical, and microbial contamination as well as against deterioration of
finished products or their containers; and
16. All vehicles and transportation equipment
used in the transportation of Marijuana Products or Edibles requiring
temperature control for safety shall be designed, maintained, and equipped as
necessary to provide adequate temperature control to prevent the Marijuana
Products or Edibles from becoming unsafe during transportation, consistent with
applicable requirements pursuant to
21 CFR
1.908(c).
(c) All Marijuana Establishments, including
those that develop or Process Edibles, shall comply with sanitary requirements.
All Edibles shall be prepared, handled, and stored in compliance with the
sanitation requirements in
105 CMR 590.000:
State Sanitary Code Chapter X: Minimum Sanitation Standards for Food
Establishments.
(d) Unless
otherwise authorized by the Commission, a CMO shall comply with 935 CMR
500.105(3) and
501.105(3):
Handling of Marijuana.
(4)
Advertising
Requirements.
(a)
Permitted Practices. The following Advertising
activities are permitted:
1. A Marijuana
Establishment may develop a Brand Name to be used in labeling, signage, and
other materials; provided however, that use of medical symbols, images of
Marijuana or Marijuana Products or related Paraphernalia images that are
appealing to persons younger than 21 years old, and colloquial references to
Marijuana and Cannabis are prohibited from use in the Brand Name
2. Brand Name Sponsorship of a charitable,
sporting or similar event, so long as the following conditions are met.
a. Sponsorship of the event is limited to the
Brand Name.
b. Any Advertising at
or in connection with such an event is prohibited, unless such Advertising is
targeted to entrants or participants reasonably expected to be 21 years of age
or older, as determined by reliable, current audience composition data, and
reasonable safeguards have been employed to prohibit Advertising from targeting
or otherwise reaching entrants or participants reasonably expected to be
younger than 21 years old, as determined by reliable, current audience
composition data;
3.
Brand Name Sponsorship of a charitable, cultural or similar event both held and
organized by the city or town in which the sponsoring Marijuana Establishment
or CMO is licensed to conduct business, so long as the following conditions are
met:
a. Sponsorship of said event shall be
included in its Positive Impact Plan submitted in accordance with
935 CMR
500.101(1)(a)11;
b. Sponsorship of the event is limited to the
Brand Name;
c. Any Advertising at
or in connection with such an event is prohibited, unless such Advertising is
targeted to entrants or participants reasonably expected to be 21 years of age
or older, as determined by reliable, current audience composition data, and
reasonable safeguards have been employed to prohibit Advertising from targeting
or otherwise reaching entrants or participants reasonably expected to be
younger than 21 years old, as determined by reliable, current audience
composition data;
4. A
Marijuana Establishment engaging in Brand Name Sponsorship under 935 CMR
500.105(4)(a)2. and 3. shall retain documentation of reliable, reasonable
audience composition data that is the basis for allowing any such Advertising
or branding for a period of one year, or longer if otherwise required by the
Commission, or a court or agency with jurisdiction.
5. A Marijuana Establishment may display, in
secure, locked cases, samples of each product offered for sale and subject to
the requirements of
935 CMR
500.110. These display cases may be
transparent. An authorized Marijuana Establishment Agent may remove a sample of
Marijuana from the case and provide it to the Consumer for inspection, provided
the Consumer may not consume or otherwise use the sample, unless otherwise
authorized herein;
6. The Marijuana
Establishment may post prices in the store and may respond to questions about
pricing. The Marijuana Establishment shall provide a catalogue or a printed
list of the prices and strains of Marijuana available at the Marijuana
Establishment to Consumers and may post the same catalogue or printed list on
its website and in the retail store;
7. A Marijuana Establishment may engage in
reasonable Advertising practices that are not otherwise prohibited in 935 CMR
500.105(4)(b) that do not jeopardize the public health, welfare or safety of
the general public or promote the diversion of Marijuana or Marijuana use in
individuals younger than 21 years old or otherwise promote practices
inconsistent with the purposes of M.G.L. c. 94G or 94I. Any such Advertising
created for viewing by the public shall include the statement "Please Consume
Responsibly", in a conspicuous manner on the face of the advertisement and
shall include a minimum of two of the following warnings in their entirety in a
conspicuous manner on the face of the advertisement:
a. "This product may cause impairment and may
be habit forming.";
b. "Marijuana
can impair concentration, coordination and judgment. Do not operate a vehicle
or machinery under the influence of this drug.";
c. "There may be health risks associated with
consumption of this product.";
d.
"For use only by adults 21 years of age or older. Keep out of the reach of
children."; or
e. "Marijuana should
not be used by women who are pregnant or breastfeeding."
8. All Advertising produced by or on behalf
of a Marijuana Establishment for Marijuana or Marijuana Products shall include
the following warning, including capitalization, in accordance with M.G.L. c.
94G, § 4(a1/2)(xxvi):
"This product has not been analyzed or approved by the Food and Drug Administration (FDA). There is limited information on the side effects of using this product, and there may be associated health risks. Marijuana use during pregnancy and breast-feeding may pose potential harms. It is against the law to drive or operate machinery when under the influence of this product. KEEP THIS PRODUCT AWAY FROM CHILDREN. There may be health risks associated with consumption of this product. Marijuana can impair concentration, coordination, and judgment. The impairment effects of Edibles may be delayed by two hours or more. In case of accidental ingestion, contact poison control hotline 1-800-222-1222 or 9-1-1. This product may be illegal outside of MA."
9. A Licensee may
utilize employee discounts as part of the Marijuana Establishment's operating
policy and procedure for prevention of diversion pursuant to
935 CMR
500.101(1)(c)8.b.
Institution of an employee discount program under 500.101(1)(c)8.b. shall not
be considered a prohibited practice under 935 CMR
500.105(4)(b).
(b)
Prohibited Practices. The following Advertising
activities are prohibited:
1. Advertising in
such a manner that is deemed to be is deceptive, misleading, false or
fraudulent, or that tends to deceive or create a misleading impression, whether
directly or by omission or ambiguity;
2. Advertising by means of television, radio,
internet, mobile applications, social media, or other electronic communication,
billboard or other outdoor Advertising, or print publication, unless at least
85% of the audience is reasonably expected to be 21 years of age or older as
determined by reliable and current audience composition data;
3. Advertising that utilizes statements,
designs, representations, pictures or illustrations that portray anyone younger
than 21 years old;
4. Advertising
including, but not limited to, mascots, cartoons, and celebrity endorsements,
that is deemed to appeal to a person younger than 21 years old;
5. Brand sponsorship including, but not
limited to, mascots, cartoons, and celebrity endorsements, that is deemed to
appeal to a person younger than 21 years old;
6. Advertising, including statements by a
Licensee, that makes any false or statements concerning other Licensees and the
conduct and products of such other Licensees that is deceptive, misleading,
false or fraudulent, or that tends to deceive or create a misleading
impression, whether directly or by omission or ambiguity;
7. Advertising by a Licensee that asserts
that its products are safe, or represent that its products have curative or
therapeutic effects, other than labeling required pursuant to M.G.L. c. 94G,
§ 4(a1/2)(xxvi), unless supported by substantial evidence or
substantial clinical data with reasonable scientific rigor as determined by the
Commission;
8. Advertising on any
billboards, or any other public signage, which fails to comply with all state
and local ordinances and requirements;
9. Use of any illuminated or external signage
beyond the period of 30 minutes before sundown until closing; provided,
however, that the Commission may further specify minimum signage
requirements;
10. The use of
vehicles equipped with radio or loudspeakers for the Advertising of Marijuana
or Marijuana Products;
11. The use
of radio or loudspeaker equipment in any Marijuana Establishment for the
purpose of Advertising the sale of Marijuana or Marijuana Products;
12. Brand Name Sponsorship of a charitable,
sporting or similar event, unless such Advertising is targeted to entrants or
participants reasonably expected to be 21 years of age or older, as determined
by reliable, current audience composition data, and reasonable safeguards have
been employed to prohibit Advertising from targeting or otherwise reaching
entrants or participants reasonably expected to be under 21 years of age, as
determined by reliable, current audience composition data;
13. Operation of any website of a Marijuana
Establishment that fails to verify that the entrant is 21 years of age or
older;
14. Any Advertising,
including the use of Brand Names, of an improper or objectionable nature
including, but not limited to, the use of language or images offensive or
disparaging to certain groups;
15.
Any Advertising, solely for the promotion of Marijuana or Marijuana Products on
Marijuana Establishment Branded Goods including, but not limited to, clothing,
cups, drink holders, apparel accessories, electronic equipment or accessories,
sporting equipment, novelty items and similar portable promotional
items;
16. Advertising on or in
public or private vehicles and at bus stops, taxi stands, transportation
waiting areas, train stations, airports, or other similar transportation venues
including, but not limited to, vinyl-wrapped vehicles or signs or logos on
transportation vehicles not owned by the Marijuana Establishment;
17. The display of signs or other printed
material Advertising any brand or any kind of Marijuana or Marijuana Products
that are displayed on the exterior of any licensed Premises;
18. Advertising of the price of Marijuana or
Marijuana Products, except as permitted above pursuant to 935 CMR
500.105(4)(a)6.;
19. Display of
Marijuana or Marijuana Products so as to be clearly visible to a person from
the exterior of a Marijuana Establishment; and
20. Advertising through the marketing of free
promotional items including, but not limited to, gifts, giveaways, discounts,
points-based reward systems, customer loyalty programs, coupons, and "free" or
"donated" Marijuana, except as otherwise permitted by 935 CMR 500.105(4)(a)9.
and except for the provision of Brand Name take-away bags by a Marijuana
Establishment for the benefit of customers after a retail purchase is
completed.
(c) Nothing in
935 CMR 500.105(4) prohibits a Marijuana Establishment from using a mark
provided by the Commission which uses images of Marijuana or Marijuana
Products. CMOs shall comply with the requirements of each 935 CMR 500.105(4)
and
501.105(4)
with respect to the applicable license. A
CMO may develop a single marketing campaign; provided, however, it shall apply
the most restrictive requirements applicable under either
license.
(5)
Labeling of Marijuana and Marijuana Products.
(a)
Labeling of Marijuana Not
Sold as a Marijuana Product. Prior to Marijuana being sold or
Transferred, a Marijuana Establishment shall ensure the placement of a legible,
firmly Affixed label on which the wording is no less than
1/16 inch in size
on each package of Marijuana that it makes available for retail sale containing
at a minimum the following information:
1.
The name and registration number, telephone number and email address of the
Licensee that produced the Marijuana, together with the retail Licensee's
business telephone number, email address, and website information, if
any;
2. The date that the Marijuana
Establishment packaged the contents and a statement of which Licensee performed
the packaging;
3. A batch number,
sequential serial number, and bar code when used, to identify the batch
associated with manufacturing and Processing;
4. Net weight or volume in U.S. customary and
metric units, listed in that order;
5. The full Cannabinoid Profile of the
Marijuana contained within the package, including THC and other Cannabinoid
levels;
6. A statement and a seal
certifying that the product has been tested for contaminants, that there were
no adverse findings, and the date of testing in accordance with M.G.L. c. 94G,
§ 15;
7. This statement,
including capitalization;
"This product has not been analyzed or approved by the FDA. There is limited information on the side effects of using this product, and there may be associated health risks. Marijuana use during pregnancy and breast-feeding may pose potential harms. It is against the law to drive or operate machinery when under the influence of this product. "KEEP THIS PRODUCT AWAY FROM CHILDREN.";
8. The
following symbol or easily recognizable mark issued by the Commission that
indicates the package contains Marijuana:
Click to view image
9. The
following symbol or other easily recognizable mark issued by the Commission
that indicates that the product is harmful to children:
Click to view image
10. 935 CMR
500.105(5)(a) shall apply to Marijuana packaged as a Finished
Marijuana Product for purposes of Wholesale to a Delivery Operator for delivery to Consumers, provided that the Marijuana Cultivator, Microbusiness or Craft Marijuana Cooperative is responsible for compliance with 935 CMR 500.105(5) for all Marijuana intended to be wholesaled for delivery to Consumers by a Delivery Operator. White labeling of Finished Marijuana Products wholesaled from a Marijuana Cultivator, Microbusiness or Craft Marijuana Cooperative for delivery to Consumers by a Delivery Operator may be performed by either Licensee, provided that white labeling is explicitly authorized by the Commission under the specific Delivery Operator License and reflected in any Wholesale Agreement.
11.
935 CMR 500.105(5)(a) shall not apply to Marijuana packaged for transport of
wholesale cultivated Marijuana in compliance with 935 CMR 500.105(8); provided
however, that the Marijuana Retailer is responsible for compliance with 935 CMR
500.105(5) for all Marijuana sold or displayed to
Consumers.
(b)
Labeling of Edibles. Prior to Edibles being sold or
Transferred, the Marijuana Product Manufacturer shall place a legible, firmly
Affixed label on which the wording is no less than
1/16 inch in size
on each Edible that it prepares for retail sale or wholesale, containing at a
minimum the following information:
1. The
name and registration number of the Marijuana Product Manufacturer that
produced the Marijuana Product, together with the Marijuana Product
Manufacturer's business telephone number, e-mail address, and website
information, if any;
2. The name of
the Marijuana Product;
3.
Refrigeration of the product is required, as applicable;
4. Total net weight or volume in U.S.
customary and metric units, listed in that order, of the Marijuana
Product;
5. The number of servings
within the Marijuana Product based on the limits provided in
935 CMR
500.150(3) and the specific
weight in milligrams of a serving size;
6. The type of Marijuana used to produce the
product, including what, if any, Processing technique or solvents were
used;
7. A list of ingredients,
including the full Cannabinoid Profile of the Marijuana contained within the
Marijuana Product, including the amount of delta-nine-tetrahydrocannabinol
(Î"9-THC) and other Cannabinoids in the package and in each serving of a
Marijuana Product as expressed in absolute terms and as a percentage of
volume;
8. The amount, in grams, of
sodium, sugar, carbohydrates and total fat per serving;
9. The date of creation and the recommended
"use by" or expiration date which may not be altered or changed;
10. A batch number, sequential serial number
and bar codes when used, to identify the batch associated with manufacturing
and Processing;
11. Directions for
use of the Marijuana Product;
12. A
statement and a seal that the product has been tested for contaminants, that
there were no adverse findings, and the date of testing in accordance with
M.G.L. c. 94G, § 15;
13. A
warning if nuts or other Known Allergens are contained in the product;
and
14. This statement, including
capitalization: "The impairment effects of edible products may be delayed by
two hours or more. This product has not been analyzed or approved by the FDA.
There is limited information on the side effects of using this product, and
there may be associated health risks. Marijuana use during pregnancy and
breast-feeding may pose potential harms. It is against the law to drive or
operate machinery when under the influence of this product. KEEP THIS PRODUCT
AWAY FROM CHILDREN.";
15. The
following symbol or easily recognizable mark issued by the Commission that
indicates the package contains Marijuana:
Click to view image
16. The
following symbol or other easily recognizable mark issued by the Commission
that indicates that the product is harmful to children:
Click to view image
17.
935 CMR 500.105(5)(b) shall apply to Edibles produced by a Marijuana Product
Manufacturer for transport to a Licensee in compliance with 935 CMR 500.105(8)
and shall be in addition to any regulation regarding the appearance of Edibles
under
935 CMR
500.150.
18. The White Labeling of Edibles to be sold
and delivered by a Delivery Operator may be conducted by the licensed
Microbusiness or Product Manufacturer of the Edible at the Microbusiness's or
Product Manufacturer's Premises or by the Delivery Operator at the Warehouse of
the Delivery Licensee, provided that White Labeling is explicitly authorized by
the Commission under the specific Delivery Operator License and reflected in
any Wholesale Agreement.
(c)
Labeling of Marijuana
Concentrates and Extracts. Prior to Marijuana concentrates or
extracts being sold or Transferred, the Marijuana Product Manufacturer shall
place a legible, firmly Affixed label on which the wording is no less than
1/16 inch in size
on each Marijuana concentrate container that it prepares for retail sale or
wholesale, containing at a minimum the following information:
1. The name and registration number of the
Marijuana Product Manufacturer that produced the Marijuana Product, together
with the Marijuana Product Manufacturer's business telephone number, e-mail
address, and website information, if any;
2. The name of the Marijuana
Product;
3. Product identity
including the word "concentrate" or "extract" as applicable;
4. Total net weight or volume expressed in
U.S. customary units and metric units, listed in that order, of the Marijuana
Product;
5. If applicable, the
number of servings in the Marijuana Product based on the limits provided in
935 CMR
500.150(4) and the specific
weight in milligrams of a serving size;
6. The type of Marijuana used to produce the
product including what, if any, Processing technique or solvents were
used;
7. A list of ingredients
including, but not limited to, the full Cannabinoid Profile of the Marijuana
contained within the Marijuana Product, including the amount of
delta-nine-tetrahydrocannabinol (Î"9-THC) and other Cannabinoids in the
package and in each serving of a Marijuana Product as expressed in absolute
terms and as a percentage of volume, and the amount of specific additives
infused or incorporated during the manufacturing process, whether active or
inactive including, but not limited to, thickening agents, thinning agents, and
specific terpenes, expressed in absolute terms and as a percentage of volume.
a. For Marijuana Vaporizer Devices,
identification of specific additives shall include, but not be limited to, any
additives identified on the FDA's Inactive Ingredient Database for "Respiratory
(inhalation)" or "Oral" routes of administration and based on dosage form as an
aerosol product or inhalant. The FDA Inactive Ingredient Database is available
at https://www.fda.gov/media/72482/download.
If the FDA database or its equivalent is no longer available, licensees shall
use the database identified by the Commission.
b. For Marijuana Vaporizer Devices produced
using only cannabis-derived terpenes, the following statement: "This product
was produced using only cannabis-derived terpenes."
c. For Marijuana Vaporizer Devices produced
using terpenes other than cannabis-derived terpenes, the following statement:
"This product was produced using terpenes derived from sources other than
cannabis."
8. The date of
creation and the recommended "use by" or expiration date;
9. A batch number, sequential serial number,
and bar code when used, to identify the batch associated with manufacturing and
Processing;
10. Directions for use
of the Marijuana Product;
11. A
statement and a seal that the product has been tested for contaminants, that
there were no adverse findings, and the date of testing in accordance with
M.G.L. c. 94G, § 15;
12. A
warning if nuts or other Known Allergens are contained in the
product;
13. This statement,
including capitalization: "This product has not been analyzed or approved by
the FDA. There is limited information on the side effects of using this
product, and there may be associated health risks. Marijuana use during
pregnancy and breast-feeding may pose potential harms. It is against the law to
drive or operate machinery when under the influence of this product. KEEP THIS
PRODUCT AWAY FROM CHILDREN.";
14.
The following symbol or easily recognizable mark issued by the Commission that
indicates the package contains Marijuana:
Click to view image
15.
The following symbol or other easily recognizable mark issued by the Commission
that indicates that the product is harmful to children:
Click to view image
(d)
Labeling of Marijuana Infused
Tinctures and Topicals. Prior to Marijuana infused Tinctures or
topicals being sold or Transferred the Marijuana Product Manufacturer shall
place a legible, firmly Affixed label on which the wording is no less than
1/16 inch in size
on each container of Marijuana infused Tincture or topical that it prepares for
retail sale or wholesale, containing at a minimum the following information:
1. The name and registration number of the
Marijuana Product Manufacturer that produced the Marijuana Product, together
with the Marijuana Product Manufacturer's business telephone number, e-mail
address, and website information, if any;
2. The Marijuana Product's
identity;
3. The type of Marijuana
used to produce the product, including what, if any, Processing technique or
solvents were used;
4. A list of
ingredients, including the full Cannabinoid Profile of the Marijuana contained
within the Marijuana Product, including the amount of
delta-nine-tetrahydrocannabinol (A9-THC) and other Cannabinoids in the package
and in each serving of a Marijuana Product as expressed in absolute terms and
as a percentage of volume;
5. Total
net weight or volume as expressed in U.S. customary units and metric units,
listed in that order, of the Marijuana Product;
6. If applicable, the number of servings in
the Marijuana Product based on the limits provided in 935 CMR 500.150(4) and
the specific weight in milligrams of a serving size;
7. The date of product creation;
8. A batch number, sequential serial number,
and bar code when used, to identify the batch associated with manufacturing and
Processing;
9. Directions for use
of the Marijuana Product;
10. A
statement and a seal that the product has been tested for contaminants, that
there were no adverse findings, and the date of testing in accordance with
M.G.L. c. 94G, §15;
11. A
warning if nuts or other Known Allergens are contained in the product;
and
12. This statement, including
capitalization: "This product has not been analyzed or approved by the FDA.
There is limited information on the side effects of using this product, and
there may be associated health risks. Marijuana use during pregnancy and
breast-feeding may pose potential harms. It is against the law to drive or
operate machinery when under the influence of this product. KEEP THIS PRODUCT
AWAY FROM CHILDREN.";
13. The
following symbol or easily recognizable mark issued by the Commission that
indicates the package contains Marijuana:
Click to view image
14. The
following symbol or other easily recognizable mark issued by the Commission
that indicates that the product is harmful to children:
Click to view image
(e)
Labeling of Repackaged
Marijuana. Prior to Repackaged Marijuana being sold, the Retailer
shall place a legible, firmly Affixed label on which the wording is no less
than
1/16 inch in size
on each container of Marijuana that it prepares for retail sale,
1. The Affixed label shall contain at a
minimum the following information:
a. The
name and registration number of the Cultivator that produced the
Marijuana;
b. Business or trade
name of licensee that packaged the product, if different from the
Cultivator;
c. Date of
Harvest;
d. Type of Marijuana or
name of strain;
e. The full
Cannabinoid Profile of the Marijuana contained within the Repackaged Product,
including the amount of delta-nine-tetrahydrocannabinol (A9-THC) and other
Cannabinoids in the package;
f. The
net weight or volume as expressed in U.S. customary units or metric
units;
g. A batch number,
sequential serial number, and bar code when used, to identify the batch
associated with manufacturing and Processing;
h. A statement and a seal that the product
has been tested for contaminants, that there were no adverse findings, and the
date of testing in accordance with M.G.L. c. 94G, § 15;
i. This statement, including capitalization:
"This product has not been analyzed or approved by the FDA. There is limited
information on the side effects of using this product, and there may be
associated health risks. Marijuana use during pregnancy and breast-feeding may
pose potential harms. It is against the law to drive or operate machinery when
under the influence of this product.
KEEP THIS PRODUCT
AWAY FROM CHILDREN.";
j. The following symbol or easily
recognizable mark issued by the Commission that indicates the package contains
Marijuana:
Click to view image
k. The
following symbol or other easily recognizable mark issued by the Commission
that indicates that the product is harmful to children:
Click to view image
(f) In circumstances where the labeling of
the Marijuana Product is unreasonable or impractical, the Marijuana
Establishment may include the labeling information on a peel-back label or may
place the product in a take-away bag with an insert or additional, easily
readable label placed within that bag.
(6)
Packaging of Marijuana and Marijuana Products.
(a)
Child-resistant
Packaging. Licensees licensed subject to 935 CMR 500.050(4) shall
ensure that all Marijuana Products that are provided for sale to Consumers by a
Licensee shall be sold in child-resistant packaging. Licensees licensed subject
to 935 CMR 500.050(2) shall ensure that all Finished Marijuana Products
provided at wholesale for delivery to Consumers by a Marijuana Delivery
Operator shall be sold in child-resistant packaging. To comply with 935 CMR
500.105(6), Licensees shall ensure:
1. That
to the extent it is not Unreasonably Impracticable for the specific type of
product, Marijuana Products are packaged in containers that are:
a. Opaque and plain in design;
b. Do not use bright colors, cartoon
characters and other features designed to appeal to minors;
c. Resealable for any marijuana product
intended for more than a single use or containing multiple servings;
and
d. Certified by a qualified
child-resistant packaging testing firm that the packaging complies with the
most recent poison prevention packaging regulations of the U.S. Consumer
Product Safety Commission as included at 16 CFR 1700: Poison Prevention
Packaging.
2.
That where compliance with the requirements of child-resistant packaging is
deemed to be Unreasonably Impracticable, Marijuana or Marijuana Products shall
be placed in an exit package that is:
a.
Capable of being resealed and made child-resistant resistant again after it has
been opened;
b. Includes the
following statement, including capitalization, in at least ten-point Times New
Roman, Helvetica or Arial font: "KEEP OUT OF REACH OF CHILDREN."; and
c. Is certified by a qualified third-party
child-resistant packaging testing firm that the packaging complies the most
recent poison prevention packaging regulations of the U.S. Consumer Product
Safety Commission as included at 16 CFR 1700: Poison Prevention
Packaging.
(b)
Limits on Packaging
Design. Packaging for Marijuana or Marijuana Products sold or
displayed for Consumers, including any label or imprint affixed to any
packaging containing Marijuana, Marijuana Products or any exit packages, may
not be attractive minors. Packaging is explicitly prohibited from:
1. Using bright colors, defined as colors
that are "neon" in appearance;
2.
Imitating or having a semblance to any existing branded consumer products,
including foods and Beverages, that do not contain marijuana;
3. Featuring cartoons;
4. Featuring a design, brand or name that
resembles a non-cannabis consumer product of the type that is typically
marketed to minors;
5. Featuring
symbols or celebrities that are commonly used to market products to
minors;
6. Featuring images of
minors; and
7. Featuring words that
refer to products that are commonly associated with minors or marketed to
minors.
(c)
Packaging of Multiple Servings.
1. Packaging for Marijuana Products sold or
displayed for Consumers in multiple servings shall include the following
statement on the exterior of the package in a printed font that is no smaller
than ten-point Times New Roman, Helvetica or Arial, including capitalization:
"INCLUDES MULTIPLE SERVINGS".
2.
Packaging for Marijuana Products in solid form sold or displayed for Consumers
in multiple servings shall allow a Consumer to easily perform the division into
single servings.
a. Edibles in a solid form
shall be easily and permanently scored to identify individual
servings.
b. Notwithstanding 935
CMR 500.105(6)(c)2.a., where a product is unable, because of its form, to be
easily and permanently scored to identify individual servings, the product
shall be packaged in a single serving size. The determination of whether a
product can be easily and permanently scored shall be decided by the Commission
consistent with sub-regulatory guidelines established by the Commission and
provided to Licensees.
c. Packaging
for Marijuana Product Beverages shall be packages solely in a single serving
size. Multiple-serving Beverages are strictly prohibited for
sale.
(d) Each
single serving of an Edibles contained in a multiple-serving package shall be
marked, stamped or otherwise imprinted with the symbol issued by the Commission
under 935 CMR 500.105(5) that indicates that the single serving is a Marijuana
Product.
(e) Serving size shall be
determined by the processor, but in no instance shall an individual serving
size of any Marijuana Product contain more than five milligrams of
delta-nine-tetrahydrocannabinol (Î"9-THC) subject to the testing variance
specified in
935 CMR
500.160(12).
(f) CMOs shall comply with the packaging
requirements in 935 CMR 500.105(6) for adult use sales or
935
CMR 501.105(6) for medical
use sales.
(7)
Packaging and Labeling Preapproval. Prior to Marijuana
or Marijuana Product being sold at a Marijuana Establishment, a CMO, a Licensee
or License Applicant may submit an application for packaging and label approval
to the Commission. An application for preapproval may be submitted at any time
prior to Marijuana or Marijuana Product being sold or at any time a substantive
change is made to the packaging or labeling of Marijuana or Marijuana Product.
The Commission shall charge a fee for packaging and labeling preapproval
pursuant to
935 CMR 500.005.
(a) Packaging and labeling preapproval review
shall be limited to the physical attributes of, and statutorily required
warnings on, the packaging and label including, but not limited to, legibility,
but shall not include a review of specific Independent Testing Laboratory test
results required pursuant to 935 CMR 500.105(5) and (6). The packaging and
labeling preapproval process shall be in addition to the requirements of 935
CMR 500.105(4) through (6).
(b) In
addition to an application for packaging and labeling preapproval in a form and
manner determined by the Commission, an applicant for preapproval shall submit
electronic files of the following to the Commission:
1. For packaging preapproval, two images of
the packaging, one depicting the front of the packaging and one depicting the
back of the packaging. Photographs shall be electronic files in a JPEG format
with a minimum photo resolution of 640 x 480 and print resolution of 300 DPI.
Photographs shall be against a white background.
2. For labeling preapproval, one image of
each label requested for review. Photographs shall be electronic files in a
JPEG format with a minimum photo resolution of 640 x 480 and print resolution
of 300 DPI. Photographs shall be against a white
background.
(c) The
Commission shall make every effort to make a preapproval determination based on
information submitted. In the event that a preapproval determination is unable
to be made conclusively based on submitted photographs, the Commission may
request to view the packaging or label in person or through a video conference.
Any such request by the Commission shall be made to the applicant
electronically or in writing.
(8)
Inventory and
Transfer.
(a) Subject to
Marijuana or Marijuana Products being entered into the Seed-to-sale SOR, a
Marijuana Establishment may Transfer product to an MTC; and an MTC may Transfer
product to a Marijuana Establishment as long as there is no violation of the
dosing limitations set forth in
935 CMR
500.150(4) or the
limitations on total MTC inventory as set forth in
935
CMR 501.105(8)(m)1. Such
Transfers cannot violate provisions protecting patient supply under
935 CMR
500.140(15). An MTC shall
limit its Transfer of inventory of seeds, plants, and Usable Marijuana to
reflect the projected needs of Registered Qualifying Patients.
(b) Real-time inventory shall be maintained
as specified by the Commission and in 935 CMR 500.105(8)(c) and (d) including,
at a minimum, an inventory of Marijuana plants; Marijuana plant-seeds and
Clones in any phase of development such as Propagation, Vegetation, and
Flowering; Marijuana ready for dispensing; all Marijuana Products; and all
damaged, defective, expired, or contaminated Marijuana and Marijuana Products
awaiting disposal.
(c) A Marijuana
Establishment shall:
1. Establish inventory
controls and procedures for the conduct of inventory reviews, and comprehensive
inventories of Marijuana Products in the process of cultivation, and finished,
stored Marijuana;
2. Conduct a
monthly inventory of Marijuana in the process of cultivation and finished,
stored Marijuana;
3. Conduct a
comprehensive annual inventory at least once every year after the date of the
previous comprehensive inventory; and
4. Promptly transcribe inventories if taken
by use of an oral recording device.
(d) The record of each inventory shall
include, at a minimum, the date of the inventory, a summary of the inventory
findings, and the names, signatures, and titles of the individuals who
conducted the inventory.
(e) A
Marijuana Establishment shall attach plant tags to all Marijuana, Clones, and
plants and attach package tags to all Finished Marijuana and Marijuana
Products, and track all Marijuana seeds, Clones, plants, and Marijuana
Products, using a Seed-to-sale methodology in a form and manner to be approved
by the Commission.
(f) The failure
to enter inventory into the Seed-to-sale SOR may result in the suspension or
revocation of a Marijuana Establishment License.
(g) Any distribution and acquisition of
Marijuana and Marijuana Products shall be tracked in the Seed-to-sale SOR in a
form and manner determined by the Commission. Any distribution of Marijuana and
Marijuana Products that is not tracked in the Seed-to-sale SOR may result in
the suspension or revocation of a Marijuana Establishment License or other
administrative action.
(h) No
Marijuana Product, including Marijuana, may be sold or otherwise marketed for
adult use that has not first been tested by Independent Testing Laboratories,
except as allowed under
935 CMR
500.000: Adult Use of Marijuana.
(i) A CMO shall implement procedures for
electronic separation of medical and adult use Marijuana, MIPs, and Marijuana
Products in the Seed-to-sale SOR.
(j) A CMO shall designate whether Marijuana
or MIPs, or Marijuana Products are intended for sale for adult use or medical
use through the SOR. Products shall be transferred to the appropriate license
within the Seed-to-sale SOR prior to sale. After the point of sale, there shall
be a reconciliation of that inventory in the SOR.
(9)
Recordkeeping.
Records of a Marijuana Establishment shall be available for inspection by the
Commission, on request. The financial records of a Marijuana Establishment
shall be maintained in accordance with generally accepted accounting
principles. Written records that are required and are subject to inspection
include, but are not necessarily limited to, all records required in any
section of
935 CMR
500.000, in addition to the following:
(a) Written Operating Procedures as required
by 935 CMR 500.105(1);
(b)
Inventory Records as required by 935 CMR 500.105(8);
(c) Seed-to-sale SOR Electronic Tracking
System records for all Marijuana Products as required by 935 CMR
500.105(8)(e);
(d) The following
personnel records:
1. Job descriptions for
each employee and volunteer position, as well as organizational charts
consistent with the job descriptions;
2. A personnel record for each Marijuana
Establishment Agent. Such records shall be maintained for at least 12 months
after termination of the individual's affiliation with the marijuana
establishment and shall include, at a minimum, the following:
a. All materials submitted to the commission
pursuant to
935 CMR
500.030(2);
b. Documentation of verification of
references;
c. The job description
or employment contract that includes duties, authority, responsibilities,
qualifications, and supervision;
d.
Documentation of all required training, including training regarding privacy
and confidentiality requirements, and the signed statement of the individual
indicating the date, time, and place he or she received said training and the
topics discussed, including the name and title of presenters;
e. Documentation of periodic performance
evaluations;
f. A record of any
disciplinary action taken; and
g.
Notice of completed Responsible Vendor Training Program and in-house training
for Marijuana Establishment Agents required under 935 CMR 500.105(2).
3. A staffing plan that will
demonstrate accessible business hours and safe cultivation
conditions;
4. Personnel policies
and procedures, including, at a minimum, the following:
a. Code of ethics;
b. Whistle-blower policy; and
c. A policy which notifies persons with
disabilities of their rights under
https://www.mass.gov/service-details/about-employment-rights
or a comparable link, and includes provisions prohibiting discrimination and
providing reasonable accommodations; and
(e) Business records, which shall include
manual or computerized records of:
1. Assets
and liabilities;
2. Monetary
transactions;
3. Books of accounts,
which shall include journals, ledgers, and supporting documents, agreements,
checks, invoices, and vouchers;
4.
Sales records, including the quantity, form, and cost of marijuana products;
and
5. Salary and wages paid to
each employee, or stipend, executive compensation, bonus, benefit, or item of
value paid to any persons having direct or indirect control over the marijuana
establishment.
(f) Waste
disposal records as required under 935 CMR 500.105(12); and
(g) Following closure of a Marijuana
Establishment, all records shall be kept for at least two years at the expense
of the Marijuana Establishment and in a form and location acceptable to the
Commission.
(10)
Liability Insurance Coverage or Maintenance of Escrow.
(a) A Marijuana Establishment shall obtain
and maintain general liability insurance coverage for no less than $1,000,000
per occurrence and $2,000,000 in aggregate, annually, and product liability
insurance coverage for no less than $1,000,000 per occurrence and $2,000,000 in
aggregate, annually, except as provided in 935 CMR 500.105(10)(b) or otherwise
approved by the Commission. The deductible for each policy shall be no higher
than $5,000 per occurrence.
(b) A
Marijuana Establishment that documents an inability to obtain minimum liability
insurance coverage as required by 935 CMR 500.105(10)(a) may place in escrow a
sum of no less than $250,000 or such other amount approved by the Commission,
to be expended for coverage of liabilities.
(c) The escrow account required pursuant to
935 CMR 500.105(10)(b) shall be replenished within ten business days of any
expenditure.
(d) Reports
documenting compliance with 935 CMR 500.105(10) shall be made in a manner and
form determined by the Commission pursuant to
935 CMR
500.000.
(e) A CMO shall maintain the insurance
coverage or escrow account required under 500.105(10) or 934 CMR 501.105(10):
Liability Insurance Coverage or Maintenance of Escrow per
location.
(11)
Storage Requirements.
(a) A Marijuana Establishment shall provide
adequate lighting, ventilation, temperature, humidity, space, and equipment, in
accordance with applicable provisions of 935 CMR 500.105 and
500.110.
(b) A Marijuana Establishment shall have
separate areas for storage of Marijuana that is outdated, damaged,
deteriorated, mislabeled, or contaminated, or whose containers or packaging
have been opened or breached, until such products are destroyed.
(c) Marijuana Establishment storage areas
shall be maintained in a clean and orderly condition.
(d) Marijuana Establishment storage areas
shall be free from infestation by insects, rodents, birds, and pests of any
kind.
(e) Marijuana Establishment
storage areas shall be maintained in accordance with the security requirements
of
935 CMR
500.110.
(12)
Waste Disposal.
(a) All recyclables and waste, including
organic waste composed of or containing Finished Marijuana and Marijuana
Products, shall be stored, secured, and managed in accordance with applicable
state and local statutes, ordinances, and regulations. All exterior waste
receptacles located on the Marijuana Establishment's Premises shall be locked
and secured to prevent unauthorized access.
(b) Liquid waste containing Marijuana or
by-products of Marijuana Processing shall be disposed of in compliance with all
applicable state and federal requirements, including but not limited to, for
discharge of pollutants into surface water or groundwater (Massachusetts Clean
Waters Act, M.G.L. c. 21, §§ 26 through 53;
314 CMR 3.00: Surface
Water Discharge Permit Program;
314 CMR 5.00:
Groundwater Discharge Permit Program;
314 CMR 12.00:
Operation Maintenance and Pretreatment Standards for Wastewater
Treatment Works and Indirect Dischargers; Federal
Clean Water Act,
33 U.S.C.
1251
et seq., National
Pollutant Discharge Elimination System Permit Regulations at 40 CFR Part 122:
EPA Administered Permit Programs: The National Pollutant Discharge
Elimination System;
314 CMR 7.00: Sewer
System Extension and Connection Permit Program), or stored pending
disposal in an industrial wastewater holding tank in accordance with
314 CMR 18.00:
Industrial Wastewater Holding Tanks and Containers, Construction,
Operation, and Record Keeping Requirements.
(c) Organic material, recyclable material and
solid waste generated at a Marijuana Establishment shall be redirected or
disposed of as follows:
1. Organic and
recyclable material shall be redirected from disposal in accordance with the
waste disposal bans described at
310 CMR 19.017:
Waste Bans.
2. To
the greatest extent feasible:
a. Any
recyclable material as defined in
310 CMR 16.02:
Definitions shall be recycled in a manner approved by the
Commission; and
b. Any Marijuana
containing organic material as defined in
310 CMR 16.02:
Definitions shall be ground up and mixed with other organic
material as defined in
310 CMR 16.02:
Definitions such that the resulting mixture renders any
Marijuana unusable for its original purpose. Once such Marijuana has been
rendered unusable, the organic material may be composted or digested at an
aerobic or anaerobic digester at an operation that complies with the
requirements of
310 CMR 16.00: Site
Assignment Regulations for Solid Waste Facilities.
3. Solid waste containing Marijuana generated
at a Marijuana Establishment shall be ground up and mixed with other solid
waste at the Marijuana Establishment such that the resulting mixture renders
any Marijuana unusable for its original purpose. Once such Marijuana has been
rendered unusable, the resulting solid waste may be brought to a solid waste
transfer facility or a solid waste disposal facility (e.g.,
landfill or incinerator) that holds a valid permit issued by the Department of
Environmental Protection or by the appropriate agency in the jurisdiction in
which the facility is located.
(d) No fewer than two Marijuana Establishment
Agents shall witness and document how the solid waste or organic material
containing Marijuana is handled on-site including, but not limited to, the
grinding up, mixing, storage and removal from the Marijuana Establishment in
accordance with 935 CMR 500.105(12). When Marijuana Products or waste is
disposed or handled, the Marijuana Establishment shall create and maintain an
electronic record of the date, the type and quantity disposed or handled, the
manner of disposal or other handling, the location of disposal or other
handling, and the names of the two Marijuana Establishment Agents present
during the disposal or other handling, with their signatures. A Marijuana
Establishment shall keep these records for at least three years. This period
shall automatically be extended for the duration of any disciplinary action and
may be extended by an order of the Commission.
(13)
Transportation between
Marijuana Establishments.
(a)
General Requirements.
1. A licensed Marijuana Establishment shall
be licensed to transport its Marijuana and Marijuana Products to other licensed
establishments, including MTC's, except as otherwise provided herein.
2. Marijuana Products may only be transported
between licensed Marijuana Establishments by registered Marijuana Establishment
Agents.
3. A licensed Marijuana
Transporter may contract with a licensed Marijuana Establishment to transport
that Licensee's Marijuana Products to other licensed Marijuana
Establishments.
4. The originating
and receiving licensed Marijuana Establishments shall ensure that all
transported Marijuana Products are linked to the Seed-to-sale SOR. For the
purposes of tracking, seeds and Clones shall be properly tracked and labeled in
a form and manner determined by the Commission.
5. Any Marijuana Product that is
undeliverable or is refused by the destination Marijuana Establishment shall be
transported back to the originating establishment.
6. All vehicles transporting Marijuana
Products shall be staffed with a minimum of two Marijuana Establishment Agents.
At least one agent shall always remain with the vehicle when the vehicle
contains Marijuana or Marijuana Products.
7. Prior to leaving a Marijuana Establishment
for the purpose of transporting Marijuana Products, the originating Marijuana
Establishment shall weigh, inventory, and account for, on video, all Marijuana
Products to be transported.
8.
Within eight hours after arrival at the destination Marijuana Establishment,
the destination Marijuana Establishment shall reweigh, re-inventory, and
account for, on video, all Marijuana Products transported.
9. When videotaping the weighing,
inventorying, and accounting of Marijuana Products before transportation or
after receipt, the video shall show each product being weighed, the weight, and
the manifest.
10. Marijuana
Products shall be packaged in sealed, labeled, and tamper or child-resistant
packaging prior to and during transportation.
11. In the case of an emergency stop during
the transportation of Marijuana Products, a log shall be maintained describing
the reason for the stop, the duration, the location, and any activities of
personnel exiting the vehicle. Licensees shall comply with applicable
requirements of
935 CMR
500.110(9).
12. A Marijuana Establishment or a Marijuana
Transporter transporting Marijuana Products shall ensure that all
transportation times and routes are randomized.
13. A Marijuana Establishment or a Marijuana
Transporter transporting Marijuana Products shall ensure that all transport
routes remain within the Commonwealth.
14. All vehicles and transportation equipment
used in the transportation of Marijuana Products or Edibles requiring
temperature control for safety shall be designed, maintained, and equipped as
necessary to provide adequate temperature control to prevent the Marijuana
Products or Edibles from becoming unsafe during transportation, consistent with
applicable requirements pursuant to
21 CFR
1.908(c).
15. All vehicles shall be equipped with a
video system that includes one or more video cameras in the storage area of the
vehicle and one or more video cameras in the driver area of the vehicle and
which shall remain operational at all times during the entire transportation
process and which shall have:
a. The ability
to produce a clear color still photo whether live or recorded; and
b. A date and time stamp embedded in all
recordings which shall always be synchronized and set correctly and may not
significantly obscure the picture.
(b)
Reporting
Requirements.
1. Marijuana
Establishment Agents shall document and report any unusual discrepancy in
weight or inventory to the Commission and Law Enforcement Authorities not more
than 24 hours of the discovery of such a discrepancy.
2. Marijuana Establishment Agents shall
report to the Commission and Law Enforcement Authorities any vehicle accidents,
diversions, losses, or other reportable incidents that occur during transport,
not more than 24 hours of such accidents, diversions, losses, or other
reportable incidents.
(c)
Vehicles.
1. A
vehicle used for transporting Marijuana Products shall be:
a. Owned or leased by the Marijuana
Establishment or the Marijuana Transporter; b. Properly registered, inspected,
and insured in the Commonwealth (documentation of such status shall be
maintained as records of the Marijuana Establishment or the Marijuana
Transporter, and shall be made available to the Commission on
request);
c. Equipped with an alarm
system approved by the Commission; and
d. Equipped with functioning heating and air
conditioning systems appropriate for maintaining correct temperatures for
storage of Marijuana Products.
2. Marijuana Products may not be visible from
outside the vehicle.
3. Any vehicle
used to transport or deliver Marijuana or Marijuana Products shall comply with
applicable Massachusetts Registry of Motor Vehicles (RMV) requirements, but may
not include any additional external marking that indicate the vehicle is being
used to transport or deliver Marijuana or Marijuana Products.
4. When transporting Marijuana Products, no
other products may be transported or stored in the same vehicle.
5. No firearms may be located within the
vehicle or on a Marijuana Establishment Agent.
(d)
Storage
Requirements.
1. Marijuana
Products shall be transported in a secure, locked storage compartment that is a
part of the vehicle transporting the Marijuana Products.
2. The storage compartment shall be
sufficiently secure that it cannot be easily removed.
3. If a Marijuana Establishment, pursuant to
a Marijuana Transporter License, or a Marijuana Transporter is transporting
Marijuana Products for more than one Marijuana Establishment at a time, the
Marijuana Products for each Marijuana Establishment shall be kept in a separate
locked storage compartment during transportation and separate manifests shall
be maintained for each Marijuana Establishment.
4. If a Marijuana Establishment is
transporting Marijuana Products to multiple other Marijuana Establishments, it
may seek the Commission's permission to adopt reasonable alternative
safeguards.
(e)
Communications.
1.
Any vehicle used to transport Marijuana Products shall contain a global
positioning system (GPS) monitoring device that is:
a. Not a mobile device that is easily
removable;
b. Attached to the
vehicle at all times that the vehicle contains marijuana products;
c. Monitored by the Marijuana Establishment
or Marijuana Transporter during transport of Marijuana Products; and
d. Inspected by the commission prior to
initial transportation of Marijuana Products, and after any alteration to the
locked storage compartment.
2. Each Marijuana Establishment Agent
transporting Marijuana Products shall always have access to a secure form of
communication with personnel at the originating location when the vehicle
contains Marijuana and Marijuana Products.
3. Secure types of communication include, but
are not limited to:
a. Two-way digital or
analog radio (UHF or VHF);
b.
Cellular phone; or
c. Satellite
phone.
4. When choosing a
type of secure communications, the following shall be taken into consideration:
a. Cellular signal coverage;
b. Transportation area;
c. Base capabilities;
d. Antenna coverage; and
e. Frequency of
transportation.
5. Prior
to, and immediately after leaving the originating location, the Marijuana
Establishment Agents shall use the secure form of communication to contact the
originating location to test communications and GPS operability.
6. If communications or the GPS system fail
while on route, the Marijuana Establishment Agents transporting Marijuana
Products shall return to the originating location until the communication
system or GPS system is operational.
7. The Marijuana Establishment Agents
transporting Marijuana Products shall contact the originating location when
stopping at and leaving any scheduled location, and regularly throughout the
trip, at least every 30 minutes.
8.
The originating location shall have a Marijuana Establishment Agent assigned to
monitoring the GPS unit and secure form of communication, who shall log all
official communications with Marijuana Establishment Agents transporting
Marijuana Products.
(f)
Manifests.
1. A
manifest shall be filled out in triplicate, with the original manifest
remaining with the originating Marijuana Establishment, a second copy provided
to the destination Marijuana Establishment on arrival, and a copy to be kept
with the licensed Marijuana Establishment Agent during transportation and
returned to the Marijuana Establishment or Marijuana Transporter on completion
of the transportation.
2. Prior to
transport, the manifest shall be securely transmitted to the destination
Marijuana Establishment by facsimile or email.
3. On arrival at the destination Marijuana
Establishment, a Marijuana Establishment Agent at the destination Marijuana
Establishment shall compare the manifest produced by the agents who transported
the Marijuana Products to the copy transmitted by facsimile or email. This
manifest shall, at a minimum, include:
a. The
originating Marijuana Establishment name, address, and registration
number;
b. The names and
registration numbers of the Marijuana Establishment Agents who transported the
Marijuana Products;
c. The name and
registration number of the Marijuana Establishment Agent who prepared the
manifest;
d. The destination
Marijuana Establishment name, address, and registration number;
e. A description of the Marijuana Products
being transported, including the weight and form or type of product;
f. The mileage of the transporting vehicle at
departure from originating Marijuana Establishment and mileage on arrival at
destination Marijuana Establishment, as well as mileage on return to
originating Marijuana Establishment;
g. The date and time of departure from
originating Marijuana Establishment and arrival at destination Marijuana
Establishment for each transportation;
h. A signature line for the Marijuana
Establishment Agent who receives the Marijuana Products;
i. The weight and inventory before departure
and on receipt;
j. The date and
time that the transported products were reweighed and reinventoried;
k. The name of the Marijuana Establishment
Agent at the destination Marijuana Establishment who reweighed and
re-inventoried products; and
l. The
vehicle make, model, and license plate number.
4. The manifest shall be maintained within
the vehicle during the entire transportation process, until the delivery is
completed.
5. A Marijuana
Establishment shall retain all transportation manifests for no less than one
year and make them available to the Commission on request.
(g)
Requirements for
Agents.
1. Each employee or
agent transporting or otherwise handling Marijuana Products for a Marijuana
Transporter shall be registered as a Marijuana Establishment Agent and have a
driver's license in good standing issued by the Massachusetts Registry of Motor
Vehicles for all classes of vehicle the Marijuana Establishment Agent will
operate for the Marijuana Transporter prior to transporting or otherwise
handling Marijuana Products.
2. A
Marijuana Establishment Agent shall carry his or her Agent Registration Card at
all times when transporting Marijuana Products and shall produce his or her
Agent Registration Card to the Commission or Law Enforcement Authorities on
request.
(h) Marijuana
Transporters shall use best management practices to reduce energy and water
usage, engage in energy conservation and mitigate other environmental
impacts.
(i) A CMO can transport
adult use and medical use Marijuana and Marijuana Products if it is
appropriately licensed to do so. Where a CMO is transporting both adult use and
medical use Marijuana, MIPs and Marijuana Products, the CMO shall comply with
the more restrictive security provisions.
(14)
Access to the Commission,
Emergency Responders and Law Enforcement.
(a) The following individuals shall have
access to a Marijuana Establishment or Marijuana Establishment transportation
vehicle:
1. Representatives of the Commission
in the course of responsibilities authorized by St. 2016, c. 334, as amended by
St. 2017, c. 55, M.G.L. c. 94G, and
935 CMR
500.000;
2. Representatives of other state agencies of
the Commonwealth; and
3. Emergency
responders in the course of responding to an emergency.
(b)935 CMR
500.000 shall not be construed to prohibit access by
authorized law enforcement personnel or local public health, inspectional
services, or other permit-granting agents acting within their lawful
jurisdiction.
(15)
Energy Efficiency and Conservation. A Marijuana
Establishment shall demonstrate consideration of the following factors as part
of its operating plan and application for licensure:
(a) Identification of potential energy use
reduction opportunities (such as natural lighting and energy efficiency
measures), and a plan for implementation of such opportunities;
(b) Consideration of opportunities for
renewable energy generation including, where applicable, submission of building
plans showing where energy generators could be placed on the site, and an
explanation of why the identified opportunities were not pursued, if
applicable;
(c) Strategies to
reduce electric demand (such as lighting schedules, active load management, and
energy storage); and
(d) Engagement
with energy efficiency programs offered pursuant to M.G.L. c. 25, § 21, or
through municipal lighting plants.
(16)
Bond.
(a) Prior to commencing operations, a
Marijuana Establishment shall provide proof of having obtained a surety bond in
an amount equal to its licensure fee payable to the Marijuana Regulation Fund
to ensure payment of the cost incurred for:
1. The destruction of Cannabis goods
necessitated by a violation of M.G.L. c. 94G or
935 CMR
500.000;
2. The costs and compensation of a Court
Appointee;
3. The cessation of
operation of the Marijuana Establishment; or
4. Such other uses that the Commission may
authorize to ensure public health, safety and welfare.
(b) All bonds required under
935 CMR
500.000 shall be issued by a corporate surety licensed
to transact surety business in the Commonwealth.
(c) If the Marijuana Establishment is unable
to secure a surety bond, as required by 935 CMR 500.105(16)(a), it may place in
escrow a sum of no less than $5,000 or such other amount approved by the
Commission, to be expended for coverage of liabilities.
(17)
Social Equity
Program.
(a) There shall be a
Social Equity Program established by the Commission to provide training and
technical assistance to eligible applicants and Licensees which may include,
but may not be limited to:
1. Management,
recruitment and employee trainings;
2. Accounting and sales
forecasting;
3. Tax prediction and
compliance;
4. Legal
compliance;
5. Business plan
creation and operational development;
6. Marijuana industry best practices;
and
7. Assistance with identifying
or raising funds or capital.
(b) Eligibility for the Social Equity Program
shall be met if applicants or Licensees satisfy one or more of the following
criteria:
1. Income does not exceed 400% of
Area Median Income and Residency in an Area of Disproportionate Impact, as
defined by the Commission, for at least five of the preceding ten years, as
established by:
a. A Massachusetts driver's
record or Massachusetts ID card record;
b. A signed lease agreement that includes the
subject's name;
c. Residential
property deed that includes the subject's name;
d. School records;
e. Housing authority records;
f. Banking records;
g. Utility bills, which identifies energy and
water use; or
h. Dated notices or
correspondence from a local or state government entity that includes the
subject's name.
2.
Residency in Massachusetts for at least the preceding 12 months and a
conviction or continuance without a finding for an offense under M.G.L. c. 94C
or an equivalent conviction in Other Jurisdictions; or
3. Residency in Massachusetts for at least
the preceding 12 months and proof that the individual was either married to or
the child of an individual convicted or continuance without a finding for a
M.G.L. c. 94C offense or an equivalent conviction in Other
Jurisdictions.
4. Any individual
listed as an Owner on the original certification of an Economic Empowerment
Priority Applicant who satisfies one or more the following criteria:
a. Lived for five of the preceding ten years
in an Area of Disproportionate Impact, as determined by the
Commission;
b. Experience in one or
more previous positions where the primary population served were
disproportionately impacted, or where primary responsibilities included
economic education, resource provision or empowerment to disproportionately
impacted individuals or communities;
c. Black, African American, Hispanic or
Latino descent; or
d. Other
significant articulable demonstration of past experience in or business
practices that promote economic empowerment in Areas of Disproportionate
Impact.
5. The Commission
may, in consideration of new information and data, broaden the categories of
eligibility for the Social Equity Program by a vote of the
Commission.
(c) The
Social Equity Program is not a licensing program. Completion of the Social
Equity Program will not result in, or guarantee participants' receipt of a
License.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.