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-60-05-6.6 - Application and Licensing Process Details
Universal Citation: 216 RI Code of Rules 60 05 6.6
Current through September 18, 2024
The analytical laboratory must fulfill the following general requirements to apply for and renew a license for sampling and testing cannabis. Unless otherwise specified, all requirements of these regulations apply to the analytical laboratory.
6.6.1 General Requirements
A. Submit application for a license on forms
provided by the RIDOH for initial licensing and for license renewal.
B. Include information as the RIDOH requires
which may include affirmative evidence of ability to comply with the provisions
of the Medical Marijuana Act and these Regulations.
C. RIDOH will evaluate applicants based upon
the information provided by applicants on the application forms/submissions and
otherwise obtained during the application process.
D. Only applications that RIDOH has
determined to be complete shall be eligible for review. An applicant who
submits an incomplete application shall receive written notification from RIDOH
regarding the specific deficiencies and shall be allowed to resubmit additional
material to address these deficiencies within thirty (30) days.
E. Upon notification of an approval of an
application from RIDOH, the approved applicant must take reasonable and
documented efforts to complete the prerequisites to the issuance of a license.
If such efforts take longer than nine (9) months, the approved applicant must
show good cause to RIDOH why additional time should be granted and the
application approval should not be rescinded.
6.6.2 Submit Application to RIDOH - Articles of Incorporation, Business Plan, Zoning Compliance, Tax Affidavit, Security Plan, and Application Fee
A.
The applicant's legal and any d/b/a name(s), certificate of incorporation under
R.I. Gen. Laws §
7-6-36 or certificate of authority
under R.I. Gen. Laws §
7-6-70, articles of incorporation
and by-laws, and, if applicable, documentation of recognition as a tax-exempt
organization by the US Internal Revenue Service.
B. A business plan, including scope of
activities, budget and resource narratives, and timeline for initiating
operations.
C. The proposed
physical location of the analytical laboratory (by plat and lot number and
mailing address), if a precise location has been determined. If a precise
physical location has not been determined, a description of the general
location(s) where it may be sited, if approved, and the expected schedule for
purchasing or leasing said location(s). Regarding the proposed physical
location(s), the applicant must submit:
1.
Evidence of compliance or preliminary determination of compatibility of the
location(s) with the local zoning laws;
2. A draft diagram of the proposed
facilities, including where within the facility the cannabis will be received,
held for processing, prepared for testing, and analyzed, and where security
alarms and cameras and surveillance recording storage will be located, and
showing the location of the facility relative to streets and other public
areas;
3. A description of
objective parameters (such as distances from streets and public areas) and/or
proposed measures (such as black-out window shades) that ensure that cannabis
at the premises must not be visible from the street or other public areas;
and,
4. Evidence of either
ownership of property or agreement by owner of property to allow the operation
of an analytical laboratory on the property, if property has already been
purchased or leased at the time of the application.
D. The legal name, current address, and date
of birth of each principal officer, director, or owner of the analytical
laboratory.
E. A list of all
persons or entities (legal names and current addresses) having direct or
indirect authority over the management or policies of the analytical
laboratory.
F. If an analytical
laboratory will have a management agreement in place, it must also include a
copy of the management agreement or management agreement proposal and a list of
persons who have any ownership interest or operational control over the
management company.
G. A list of
all persons or business entities (legal names and current addresses) having any
ownership interest in the applicant entity, whether direct or
indirect.
H. If the analytical
laboratory premises and/or other operational assets will be owned or leased by
a person or entity other than the applicant, the legal name and current address
of such person or entity and a list of all persons or entities (legal names and
current addresses) having any ownership interest in such entity, whether direct
or indirect.
I. The legal names and
current addresses of all creditors holding a security interest in the premises
and/or other assets to be used in the analytical laboratory operations, if
any.
J. Tax Affidavit in accordance
with R.I. Gen. Laws Chapter 5-76.
K. All other information required by RIDOH as
described in the application form.
L. Each application must include the
non-refundable application fee as set forth in the Fee Structure for Licensing,
Laboratory, and Administrative Services Provided by the Department of Health
(Part 10-05-2 of this Title).
6.6.3 RIDOH and DBR Review
RIDOH and DBR will conduct a preliminary inspection of the proposed facility design and layout.
6.6.4 Preliminary Application Approval
If RIDOH receives all required information and the information meets all applicable requirements, the application will receive preliminary approval.
6.6.5 Building Process
A. If an
applicant is notified that its application has been preliminarily approved by
RIDOH, it must provide the following before being issued a license to operate:
1. All updates to previously submitted
application information;
2. A
sufficient description of the final physical location of the analytical
laboratory (by plat and lot number and mailing address);
3. Evidence of complete compliance of the
facility with the local zoning laws, including any conditions of approval
thereof, in the form of a letter from an authorized zoning official of the
municipality and certification by an authorized officer of the applicant as to
compliance with any other applicable local ordinances;
4. A current Certificate of Occupancy (or
equivalent document) to demonstrate compliance with the relevant provisions of
R.I. Gen. Laws Chapters 23-28.1 and 23-27.3 [Fire Safety Code and State
Building Code, respectively] for each physical address to be utilized as an
analytical laboratory;
5. Evidence
of either ownership of property or agreement by owner of property to allow the
operation of an analytical laboratory on the property;
6. A final diagram of the facilities,
including where within the facilities the cannabis will be stored and analyzed,
and where security alarms and cameras and surveillance recording storage will
be located, and showing the location of the facilities relative to streets and
other public areas;
7. Evidence of
divestiture of prohibited material financial interest and control as follows:
a. An analytical laboratory and "key persons"
thereof may not have any "material financial interest or control" in a
compassion center, a cultivator, or a licensed cooperative cultivation or vice
versa.
b. "Material financial
interest or control" means any ownership interest, regardless of the size of
the holding, and including any ownership interest through a subsidiary or
affiliate; trusteeship, mortgage, guarantor, endorser or surety relationship,
or loan relationship, except that loan relationship for the purposes of this
definition shall exclude accounts payable and accounts receivable on account of
a cannabis purchase order; any other beneficial financial interest such that
the holder bears the risk of loss (other than as an insurer) or has an
opportunity to gain profit from the operation or sale of the regulated cannabis
business; or, operational control, including but not limited to interlocking
directors or officers or through a management agreement.
c. "Key persons" means directors, officers,
and any persons with managing or operational control.
d. If an analytical laboratory application is
approved and any prohibited material, financial interest or control has been
identified by DBR or is otherwise known to the analytical laboratory applicant,
such interest or control must be divested prior to issuance of the analytical
laboratory license. The plan of divestiture must be filed with DBR.
e. The duty to divest prohibited material
financial interests and control is a continuing obligation of
licensing.
8. Evidence
that all directors, managers, officers, agents and employees of the analytical
laboratory have applied for a Cannabis Registry Identification Card(s) from
DBR.
B. The applicant
must submit the laboratory quality assurance plan and procedures manual to
RIDOH as described in §
6.11 of this Part.
6.6.6 Final Licensing Process
A. Submit documentation of
approval of occupancy from the State Fire Marshall to RIDOH.
B. Submit a copy of all Registry
Identification Card(s) from DBR to RIDOH. Each laboratory must maintain a
current list of testing agent cardholders employed by the laboratory.
C. Pay the annual license fees as set forth
in the Fee Structure for Licensing, Laboratory, and Administrative Services
Provided by the Department of Health (Part 10-05-2 of this Title).
D. The Department shall issue a license no
less than thirty (30) days after the applicant meets the licensing requirements
of these regulations.
E. Once the
license has been issued by RIDOH, the analytical laboratory must take
reasonable and documented efforts to launch analytical laboratory activities,
which for purposes of this paragraph shall mean actual cannabis sampling and
analysis and/or other cannabis activities requiring an analytical laboratory
license pursuant to these regulations. If such efforts take longer than one (1)
year, the analytical laboratory must show good cause to RIDOH why the license
should not be revoked for non-use.
F. The applicant must contact RIDOH to
coordinate a final laboratory inspection. RIDOH, DBR and/or the Rhode Island
State Police will visit the analytical laboratory to inspect the facility
security and make any recommendations regarding the security of the facility
and its personnel within ten (10) business days prior to the initial opening of
the analytical laboratory. RIDOH may also conduct an inspection at an earlier
time, if necessary, in addition to a final laboratory inspection.
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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