Rhode Island Code of Regulations
Title 216 - Department of health
Chapter 60 - Laboratories and Medical Examiner
Subchapter 05 - State Laboratory
Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis
Section 216-RICR-60-05-6.7 - Licensing
Universal Citation: 216 RI Code of Rules 60 05 6.7
Current through September 18, 2024
6.7.1 General Information
A. Licenses will not be issued to an
analytical laboratory prior to an inspection and correction of any deficiencies
in a manner acceptable to the RIDOH.
B. Analytical laboratories may receive
samples from another laboratory in this state for examination provided the
laboratory sending the samples is licensed in this state pursuant to these
rules and regulations.
C. A license
will be issued only for the premises and persons named in the application and
will not be transferable or assignable.
D. Licenses will be issued for Industrial
Hemp testing to laboratories that have obtained Drug Enforcement Agency (DEA)
Controlled Substance Registration as required by the USDA and Department of
Health Controlled Substance Registration for Analytical Laboratories.
E. The license issued will be the property of
the state and loaned to the laboratory and must be kept posted in a conspicuous
place on the premises. Said license, unless sooner suspended or revoked, shall
expire by limitation on the 31st day of December, of every year following the
date of licensing and shall be renewed annually.
F. The license issued to an analytical
laboratory shall clearly identify the name of the laboratory, the license
number, the name of the laboratory director, the issue date and expiration
date. The license will include an appendix listing of the analytes and methods
for each test category the laboratory is approved. Test categories approved for
the analysis of cannabis will be listed separately for plant material, resins,
extracts, concentrates and infused products.
G. Test categories and descriptions are as
follows:
1. Cannabis finished plant material
including finished resins, kief, and hashish:
a. Cannabinoid Potency - Quantitative
analysis including the percentage of D 9 -tetrahydrocannnabinol (D 9 -THC), D 8
-tetrahydrocannnabinol (D 8 -THC), cannabidiol (CBD), tetrahydrocannabinolic
acid (THCa) and cannabidiolic acid (CBDa) of the total amount of THC in a
cannabis product. Amounts of other cannabinoids may be reported, but are not
required.
b. Microbiological -
total viable aerobic bacteria, total coliforms, bile-tolerant gram-negative
bacteria, pathogenic E. coli, Salmonella, yeast, and mold.
c. Water Activity - total water
activity.
d. Pesticides - Residues
of pesticides and growth regulators listed in §
6.21(E)(1)(a)
of this Part.
e. Metals - Arsenic, Cadmium, Lead,
Mercury.
2. Cannabis
extracts, resins, concentrates as-is or as components of Cannabis infused
products:
a. Cannabinoid Potency -
Quantitative analysis including the percentage of D 9 -tetrahydrocannnabinol (D
9 -THC), D 8 -tetrahydrocannnabinol (D 8 -THC), cannabidiol (CBD),
tetrahydrocannabinolic acid (THCa) and cannabidiolic acid (CBDa) of the total
amount of THC in a cannabis product. Amounts of other cannabinoids may be
reported, but are not required.
b.
Solvents - Listed in §
6.21(H)(3)
of this Part.
c. Pesticides -
Residues of pesticides and growth regulators listed in §
6.21(E)(1)(a)
of this Part.
d. Metals - §
6.21(D)(2)(a)
of this Part.
3. Industrial Hemp and Hemp Products
a. According to USDA Establishment of a
Domestic Hemp Production Program 7 C.F.R. Part 990 Subpart B - State and Tribal
Hemp Production Plans as incorporated in §
6.3(C) of
this Part.
b. Testing for THC, CBD,
and/or other material characteristics such as pesticides, heavy metals, and
microbial concentration on a dry weight or per volume basis upon direction from
DBR, the Rhode Island Department of Environmental Management (DEM) or RIDOH as
applicable, as stated in §230-RICR-80-10-1.9(D)(1)(a).
4. Cannabis Infused Products
a. Cannabinoid Potency - Quantitative
analysis including the percentage of D 9 -tetrahydrocannnabinol (D 9 -THC), D 8
-tetrahydrocannnabinol (D 8 -THC), cannabidiol (CBD), tetrahydrocannabinolic
acid (THCa) and cannabidiolic acid (CBDa) of the total amount of THC in a
cannabis product. Amounts of other cannabinoids may be reported, but are not
required.
b. Potency testing of
infused products may be waived if the potency of manufactured cannabis infused
products remains consistently uniform from manufactured batch to
batch.
H. The
license will be void and returned to RIDOH if the analytical laboratory
discontinues its operation, unless the discontinuance is on a temporary basis
approved by RIDOH.
6.7.2 Post-Licensing Change Notification
A. The analytical laboratory shall provide
RIDOH with a written notice of any change described below at least thirty (30)
calendar days prior to the proposed effective date of the change:
1. Change in ownership, whether partial or
full, of the analytical laboratory as defined in §
6.4(A)(16)
of this Part;
2. Change in the
laboratory director;
3. Change in
the quality assurance officer;
4.
Merger, dissolution, or entity conversion;
5. Entering a management agreement, changing
management companies, and/or material changes to an existing management
agreement;
6. Changes in the
approved premises location for the laboratory analysis of cannabis;
7. Change to approved premises floor
plan;
8. Proposed premises
expansion; or,
9. Discontinuation
of or failure to launch analytical laboratory activities.
10. The analytical laboratory experiencing
any of the above changes unexpectedly must notify RIDOH within seventy-two
hours (72) and request a waiver that includes an explanation of how it intends
to carry on operations.
B. Unless the analytical laboratory provides
timely notification of the above changes and receives prior RIDOH approval or
waiver of the requirement of prior notice and approval (for example a
non-material change in ownership or emergency as determined by RIDOH), the
license shall be void and returned to RIDOH.
C. The analytical laboratory must follow the
process for a new application, including a new application fee, for:
1. Any proposed change of ownership, whether
full or partial;
2. Any change to a
management agreement that will effect a change of majority control and/or
decision-making authority with respect to the operation of the analytical
laboratory; and
3. Any proposed
change in an approved premises location for the laboratory analysis of
cannabis.
D. For updates
in information other than the categories requiring thirty (30) calendar days
prior notice pursuant to §6.7.2(A) of this Part, the analytical laboratory
has a continuing obligation to update, amend and/or correct any information
requested and/or submitted in the application process within ten (10) business
days after any change in the information submitted and/or any material change
in circumstances related to the application. This includes timely notification
and divestiture if a prohibited interest.
E. If the analytical laboratory proposes to
alter or expand the final floor plan previously submitted and approved, the
analytical laboratory must first submit a renovation plan for RIDOH approval at
least sixty (60) calendar days prior to commencement of construction. The
renovation plan must specifically address quality control procedures for the
protection of cannabis samples and cannabis product samples from any
contamination during the construction process and further address any other
criteria RIDOH requires.
6.7.3 Annual License Renewal
A. The Department shall issue a license if
the applicant meets the requirements of the Medical Marijuana Act and this Part
for licensing. Said license, unless sooner suspended or revoked, shall expire
by limitation on the thirty-first (31st) day of December, of every year
following the date of licensing and shall be renewed annually.
B. Annual license renewal applications shall
be submitted on such forms and include such information as prescribed by
RIDOH.
C. No license will be
renewed if, at the time of renewal, the laboratory does not meet the
requirements for licensing.
6.7.4 Denial, Suspension, or Revocation of License
A. The Department may deny,
revoke, or suspend the license of any analytical laboratory for engaging in
conduct that includes but is not limited to:
1. Failure to observe any term of
licensing;
2. Failure to observe
any order made under authority of the Medical Marijuana Act or under the
statutory authority vested in the Department;
3. Engaging in, aiding, abetting, causing, or
permitting any action prohibited under the Medical Marijuana Act;
4. Failure to comply with any regulatory
requirement stated herein and any other applicable state regulation or
statute;
5. Making false or
deceptive representation on any application for license or renewal
thereof;
6. Failure to maintain
professional and competent standards of practice;
7. Making false or deceptive representation
of any testing results and reports thereof; or,
8. Engaging in false or deceptive advertising
of laboratory testing.
B. Lists of deficiencies noted in inspections
and investigations conducted by the RIDOH shall be maintained on file in the
RIDOH and shall be considered by the RIDOH in rendering determinations to deny,
suspend, or revoke the license of an analytical laboratory.
C. Whenever action shall be proposed to deny,
suspend, or revoke the license or take another disciplinary action, the RIDOH
shall notify the facility by certified mail setting forth reasons for the
proposed action, and the applicant or licensed laboratory shall be given an
opportunity for a prompt and fair hearing in accordance with R.I. Gen. Laws
§
23-1-22 and these
Regulations.
D. If the RIDOH finds
that public health, safety and welfare imperatively requires emergency action
and incorporates a finding to that effect in its order, the RIDOH may order
summary suspension of licenses pending proceedings for revocation or other
action in accordance with R.I. Gen. Laws §§
23-1-20 and
42-35-14(c).
Disclaimer: These regulations may not be the most recent version. Rhode Island may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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