| (a) Licensees must comply with all applicable provisions
of the Texas Agriculture Code and the Texas Department of Agriculture's
administrative rules, Title 4, Part 1.
(b) Representative samples of all processed products
must be tested for the levels of tetrahydrocannabinol and cannabidiol,
and for residual solvents, pesticides, fungicides, fertilizers, mold,
and heavy metals, in accordance with applicable provisions of the
Texas Agriculture Code and Texas Department of Agriculture's administrative
rules, Title 4, Part 1, and Code of Federal Regulations, Title 16,
Part 1107.
(c) Only pesticides of minimum risk exempted under
the Federal Insecticide, Fungicide, and Rodenticide Act, 7 USC §136,
may be used on cannabis. The pesticide's active ingredients may only
be those listed in 40 CFR §152.25(f)(1). The pesticide's inert
ingredients may only be those that listed in 40 CFR §152.25(f)(2);
commonly consumed food commodities, animal feed items, and edible
fats and oils as provided in 40 CFR §180.950(a),(b) and (c);
and chemical substances listed in 40 CFR §180.950(e). All pesticide
ingredients (both active and inert) must be listed on the pesticide
container's label. The active ingredient(s) must be listed by label
display name and percentage by weight. Each inert ingredient must
be listed by label display name. The product may not bear claims to
control or mitigate organisms that pose a threat to human health,
or insects or rodents carrying specific diseases. The name of the
producer or the company for whom the product was produced and the
company's contact information must be displayed prominently on the
product label. The label cannot include any false or misleading statements.
The label must comply with the Texas Department of Agriculture's administrative
rule, 4 TAC §7.11, relating to Label Requirements.
(d) All facilities must be inspected and approved for
their use by a local fire code official, or by the state fire marshal
or local designee of the state fire marshal, and must meet any required
fire, safety, and building code requirements specified in:
(1) National Fire Protection Association (NFPA) standards;
(2) International Building Code (IBC);
(3) International Fire Code (IFC);
(4) Texas Department of Insurance administrative rules,
28 TAC Chapter 34, concerning State Fire Marshal; and
(5) Other applicable standards including following
all applicable fire, safety, and building codes in processing and
the handling and storage of the solvent or gas.
(e) Licensees must provide certification by a Texas
licensed professional engineer that the extraction system to be used
to produce low-THC cannabis products was commercially manufactured,
safe for its intended use, and built to codes of recognized and generally
accepted good engineering practices, such as:
(1) The American Society of Mechanical Engineers (ASME);
(2) American National Standards Institute (ANSI);
(3) Underwriters Laboratories (UL); or
(4) The American Society for Testing and Materials
(ASTM).
(f) The extraction process must be continuously staffed
during operations by a registered employee trained in the extraction
process, the transfer of LP-gas where applicable, and all emergency
procedures. All staff training records shall be maintained on-site
and made available upon request by the department or local law enforcement
or regulatory official.
(g) The installation, operation, repair and maintenance
of electrical systems, devices, and components shall conform to the
National Electrical Code, NFPA 70 as adopted by the Texas Department
of Licensing and Regulation. All electrical components within the
extraction room shall be interlocked with the hazardous exhaust system
and when provided, the gas detection system. When the hazardous exhaust
system is not operational, or the gas detection system is activated,
light switches and electrical outlets shall be disabled while leaving
lights on that are necessary for evacuation. The electrical systems
shall include:
(1) Extraction room lighting;
(2) Extraction room ventilation system;
(3) Solvent gas detection system;
(4) Emergency alarm systems;
(5) Automatic fire extinguishing systems;
(6) Vent failure alarm system; and
(7) Emergency power backup system.
(h) For extraction processes utilizing gaseous hydrocarbon-based
solvents, a continuous gas detection system shall be provided. The
gas detection threshold shall be no greater than 10% of the LEL/LFL
limit of the materials.
(i) Signs shall be posted at the entrance to each production
area using or storing carbon dioxide, indicating the hazard. Signs
shall be durable and permanent in nature and not less than 7 inches
wide by 10 inches tall. Signs shall bear the "skull and crossbones"
emblem with the warning "DANGER! POTENTIAL OXYGEN DEFICIENT ATMOSPHERE".
NFPA 704 signage shall be provided at the building main entry and
the rooms where the carbon dioxide is used and stored. The main entrance
to the facility and any door to a room where storage, transfer or
use of hazardous materials is conducted shall be appropriately posted
with markings in accordance with NFPA 704, Standard System for the
Identification of the Hazards of Materials for Emergency Response.
(j) Mechanical ventilation within an extraction or
processing facility shall be in accordance with the applicable local
ordinances or the appropriate NFPA standard as adopted by the State
Fire Marshal's Office if no applicable local ordinance exists, and
shall have:
(1) Mechanical ventilation in the room or area of rate
of not less than 1 cubic foot per minute per square foot;
(2) Exhaust system intake from a point within 12 inches
of the floor; and
(3) Ventilation operating at a negative pressure in
relation to the surrounding area.
(k) Any liquid extraction process using flammable and
combustible liquids in which the liquid is boiled, distilled, or evaporated
must operate in compliance with this section and NFPA 30 as adopted
by the State Fire Marshal's Office.
(l) Any processing equipment using a flammable or combustible
vapor or liquid must meet the requirements of NFPA 30 and NRPA 70.
Such equipment shall be located within a hazardous exhaust fume hood,
rated for exhausting flammable vapors. Electrical equipment used within
the hazardous exhaust fume hood shall be rated for use in flammable
atmospheres. Heating of flammable or combustible liquids over an open
flame is prohibited, with the exception that the use of a heating
element not rated for flammable atmospheres may be used where documentation
from the manufacturer or a nationally recognized testing laboratory
indicates it is rated for heating of flammable liquids.
(m) Product extraction processes may use only potable
water in compliance with Code of Federal Regulations, Title 40, Part
141.
(n) All regulated premises shall be located at least
1000 feet from any private or public school or day care center that
existed prior to the date of initial license application, measured
from the closest points on the respective property lines.
(o) All final packaging for patient consumption must
be in child-resistant packaging designed or constructed to be significantly
difficult for children under five (5) years of age to open and not
difficult for normal adults to use properly as defined by the most
current version of the Code of Federal Regulations, Title 16, Part
1700 and Title 40, Part 157.2 and American Society for Testing and
Materials (ASTM) D3475-15, Standard Classification of Child-Resistant
Packages, ASTM International, West Conshohocken, PA, 2015.
(p) All final packaging labels must include:
(1) Physician's name;
(2) Patient's name;
(3) Dispensing organization's name, state license number,
telephone number, and mailing address;
(4) Dosage prescribed and means of administration;
(5) Date the dispensing organization packaged the contents;
(6) Batch number, sequential serial number, and bar
code when used, to identify the batch associated with manufacturing
and processing;
(7) Potency of the low-THC cannabis product contained
in the package, including the levels of tetrahydrocannabinol and cannabidiol;
(8) Statement that the product has been tested for
contaminants with specific indications of all findings, and the date
of testing in accordance with Code of Federal Regulations, Title 16,
Part 1107; and
(9) Statement that the product is for medical use only
and is intended for the exclusive use of the patient to whom it is
prescribed. This statement should be in bold print.
(q) The dispensed product may contain no more than
0.5% by weight of tetrahydrocannabinols and not less than 10% by weight
of cannabidiol.
(r) The storage, transfer, and use of LP- Gas shall
conform to the regulations of the Texas Railroad Commission, including
but not limited to NFPA 58, LP Gas Code (as amended) and the adopted
standards of the State Fire Marshal's Office.
(s) The storage, use and handling of liquid carbon
dioxide shall be in accordance with Chapter 13 of NFPA 55.
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