WSR 14-21-185
EMERGENCY RULES
LIQUOR CONTROL BOARD
[Filed October 22, 2014, 10:59 a.m., effective October 22, 2014, 10:59 a.m.]
Effective Date of Rule: Immediately upon filing.
Purpose: Emergency rules are needed to provide additional clarity to the marijuana rules regarding marijuana-infused products, specifically products that are appealing to children. The mission of the board is to keep alcohol, tobacco, and marijuana out of the hands of youth. Many marijuana-infused products on the medical marijuana market today are appealing to children. Products such as lollipops, gummy bears, and cotton candy are very appealing to children too young to read a label. Clarification is also needed on the security and surveillance systems requirements at marijuana licensed premises. Good laboratory practices are also needed until permanent rules are adopted.
Citation of Existing Rules Affected by this Order: Amending WAC 314-55-077, 314-55-079, 314-55-083, and 314-55-104.
Statutory Authority for Adoption: RCW 69.50.342 and 69.50.345.
Under RCW 34.05.350 the agency for good cause finds that immediate adoption, amendment, or repeal of a rule is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest.
Reasons for this Finding: Immediate adoption of these rules is necessary for the preservation of the public health and safety. Marijuana-infused products must not be appealing to children. Security and surveillance systems at a marijuana licensed premises must ensure that all parts of the premises are covered by security at all times to protect public safety. Labs must be properly accredited to perform quality assurance testing of marijuana that the public will consume.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 1, Amended 4, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 0, Repealed 0.
Date Adopted: October 22, 2014.
Sharon Foster
Chairman
AMENDATORY SECTION (Amending WSR 14-10-044, filed 4/30/14, effective 5/31/14)
WAC 314-55-077 What is a marijuana processor license and what are the requirements and fees related to a marijuana processor license?
(1) A marijuana processor license allows the licensee to process, package, and label ((usable)) useable marijuana and marijuana-infused products for sale at wholesale to marijuana retailers.
(2) A marijuana processor is allowed to blend tested useable marijuana from multiple lots into a single package for sale to a marijuana retail licensee providing the label requirements for each lot used in the blend are met and the percentage by weight of each lot is also included on the label.
(3) A marijuana processor licensee must obtain approval from the liquor control board for all marijuana-infused products, labeling, and packaging prior to offering these items for sale to a marijuana retailer. The marijuana processor licensee must submit a picture of the product, labeling, and packaging to the liquor control board for approval.
If the liquor control board denies a marijuana-infused product for sale in marijuana retail outlets, the marijuana processor licensee may request an administrative hearing per chapter 34.05 RCW, Administrative Procedure Act.
(4) Marijuana-infused products in solid form that contain more than one serving must be scored to indicate individual serving sizes, and labeled so that the serving size is prominently displayed on the packaging.
(a) Marijuana-infused products must be homogenized to ensure uniform disbursement of cannabinoids throughout the product.
(b) All marijuana-infused products must state on the label, "This product contains marijuana."
(5) A marijuana processor is limited in the types of food or drinks they may infuse with marijuana to create ((an infused edible product)) marijuana-infused solid or liquid products meant to be ingested orally, that may be sold by a marijuana retailer. Marijuana-infused products that are designed to be especially appealing to children are prohibited.
(a) To reduce the risk to public health, ((food defined as)) potentially hazardous foods as defined in WAC ((246-215-0115(88))) 246-215-01115 may not be infused with marijuana. ((These foods are)) Potentially hazardous ((as they)) foods require time-temperature control to keep them safe for human consumption and prevent the growth of pathogenic microorganisms or the production of toxins. ((The board may designate other food items that may not be infused with marijuana.)) Any food that requires refrigeration, freezing, or a hot holding unit to keep it safe for human consumption may not be infused with marijuana.
(((4))) (b) Other foods items that may not be infused with marijuana to be sold in a retail store are:
(i) Any food that has to be acidified to make it shelf stable;
(ii) Food items made shelf stable by canning or retorting;
(iii) Fruit or vegetable juices;
(iv) Fruit or vegetable butters;
(v) Pumpkin pies, custard pies, or any pies that contain egg;
(vi) Dairy products of any kind such as butter, cheese, ice cream, or milk; and
(vii) Dried or cured meats.
(c) Vinegars and oils derived from natural sources may be infused with dried marijuana if all plant material is subsequently removed from the final product. Vinegars and oils may not be infused with any other substance, including herbs and garlic.
(d) Marijuana-infused jams and jellies made from scratch must utilize a standardized recipe in accordance with 21 C.F.R. Part 150, revised as of April 1, 2013.
(e) Per WAC 314-55-104, a marijuana processor may infuse dairy butter or fats derived from natural sources and use that extraction to prepare allowable marijuana-infused solid or liquid products meant to be ingested orally, but the dairy butter or fats derived from natural sources may not be sold as stand-alone products.
(f) The liquor control board may designate other food items that may not be infused with marijuana.
(6) The recipe for any ((food infused with marijuana to make an edible product)) marijuana-infused solid or liquid products meant to be ingested orally must be kept on file at the marijuana ((producer's)) processor's licensed premises and made available for inspection by the ((WSLCB)) liquor control board or their designee.
(((5))) (7) The application fee for a marijuana processor license is two hundred fifty dollars. The applicant is also responsible for paying the fees required by the approved vendor for fingerprint evaluation.
(((6))) (8) The annual fee for issuance and renewal of a marijuana processor license is one thousand dollars. The board will conduct random criminal history checks at the time of renewal that will require the licensee to submit fingerprints for evaluation from the approved vendor. The licensee will be responsible for all fees required for the criminal history checks.
(((7))) (9) A marijuana processor producing a marijuana-infused solid or liquid product meant to be ingested orally in a processing facility as required in WAC 314-55-015(10) must pass a processing facility inspection. Ongoing annual processing facility compliance inspections may be required. The liquor board will contract with the department of agriculture to conduct required processing facility inspections. All costs of inspections are borne by the licensee and the hourly rate for inspection is sixty dollars. A licensee must allow the liquor control board or their designee to conduct physical visits and inspect the processing facility, recipes and required records per WAC 314-55-087 during normal business hours without advance notice. Failure to pay for the processing facility inspection or to follow the processing facility requirements outlined in this section and WAC 314-55-015 will be sufficient grounds for the board to suspend or revoke a marijuana license.
(10) The board will initially limit the opportunity to apply for a marijuana processor license to a thirty-day calendar window beginning with the effective date of this section. In order for a marijuana processor application license to be considered it must be received no later than thirty days after the effective date of the rules adopted by the board. The board may reopen the marijuana processor application window after the initial evaluation of the applications that are received and processed, and at subsequent times when the board deems necessary.
(((8))) (11) Any entity and/or principals within any entity are limited to no more than three marijuana processor licenses.
(((9))) (12) Marijuana processor licensees are allowed to have a maximum of six months of their average useable marijuana and six months average of their total production on their licensed premises at any time.
(((10))) (13) A marijuana processor must accept returns of products and sample jars from marijuana retailers for destruction, but is not required to provide refunds to the retailer.
AMENDATORY SECTION (Amending WSR 14-10-044, filed 4/30/14, effective 5/31/14)
WAC 314-55-079 What is a marijuana retailer license and what are the requirements and fees related to a marijuana retailer license?
(1) A marijuana retailer license allows the licensee to sell only usable marijuana, marijuana-infused products, and marijuana paraphernalia at retail in retail outlets to persons twenty-one years of age and older.
Marijuana-infused products listed in WAC 314-55-077(5) are prohibited for sale by a marijuana retail licensee.
(2) Marijuana extracts, such as hash, hash oil, shatter, and wax can be infused in products sold in a marijuana retail store, but RCW 69.50.354 does not allow the sale of extracts that are not infused in products. A marijuana extract does not meet the definition of a marijuana-infused product per RCW 69.50.101.
(3) Internet sales and delivery of product to customers is prohibited.
(4) The application fee for a marijuana retailer's license is two hundred fifty dollars. The applicant is also responsible for paying the fees required by the approved vendor for fingerprint evaluation.
(5) The annual fee for issuance and renewal of a marijuana retailer's license is one thousand dollars. The board will conduct random criminal history checks at the time of renewal that will require the licensee to submit fingerprints for evaluation from the approved vendor. The licensee will be responsible for all fees required for the criminal history checks.
(6) Marijuana retailers may not sell marijuana products below their acquisition cost.
(7) Marijuana retailer licensees are allowed to have a maximum of four months of their average inventory on their licensed premises at any given time.
(8) A marijuana retailer may transport product to other locations operated by the licensee or to return product to a marijuana processor as outlined in the transportation rules in WAC 314-55-085.
(9) A marijuana retailer may not accept a return of product that has been opened.
AMENDATORY SECTION (Amending WSR 14-10-044, filed 4/30/14, effective 5/31/14)
WAC 314-55-104 Marijuana processor license extraction requirements.
(1) Processors are limited to certain methods, equipment, solvents, gases and mediums when creating marijuana extracts.
(2) Processors may use the hydrocarbons N-butane, isobutane, propane, or heptane or other solvents or gases exhibiting low to minimal potential human health-related toxicity approved by the board. These solvents must be of at least ninety-nine percent purity and a processor must use them in a professional grade closed loop extraction system designed to recover the solvents, work in an environment with proper ventilation, controlling all sources of ignition where a flammable atmosphere is or may be present.
(3) Processors may use a professional grade closed loop CO2 gas extraction system where every vessel is rated to a minimum of nine hundred pounds per square inch. The CO2 must be of at least ninety-nine percent purity.
(4) Certification must be provided to the liquor control board for professional grade closed loop systems used by processors ((must be)) to certify that the system was commercially manufactured and built to codes of recognized and generally accepted good engineering practices, such as:
(a) The American Society of Mechanical Engineers (ASME);
(b) American National Standards Institute (ANSI);
(c) Underwriters Laboratories (UL); or
(d) The American Society for Testing and Materials (ASTM).
(5) Professional closed loop systems, other equipment used, the extraction operation, and facilities must be approved for their use by the local fire code official and meet any required fire, safety, and building code requirements specified in:
(a) Title 296 WAC;
(b) National Fire Protection Association (NFPA) standards;
(c) International Building Code (IBC);
(d) International Fire Code (IFC); and
(e) Other applicable standards including following all applicable fire, safety, and building codes in processing and the handling and storage of the solvent or gas.
(6) Processors may use heat, screens, presses, steam distillation, ice water, and other methods without employing solvents or gases to create kief, hashish, bubble hash, or infused dairy butter, or oils or fats derived from natural sources, and other extracts.
Under WAC 314-55-077, infused dairy butter and oils or fats derived from natural sources may be used to prepare infused edible products, but they may not be prepared as stand-alone edible products for sale.
(7) Processors may use food grade glycerin, ethanol, and propylene glycol solvents to create extracts.
(8) Processors creating marijuana extracts must develop standard operating procedures, good manufacturing practices, and a training plan prior to producing extracts for the marketplace. Any person using solvents or gases in a closed looped system to create marijuana extracts must be fully trained on how to use the system, have direct access to applicable material safety data sheets and handle and store the solvents and gases safely.
(9) Parts per million for one gram of finished extract cannot exceed 500 parts per million or residual solvent or gas when quality assurance tested per RCW 69.50.348.
AMENDATORY SECTION (Amending WSR 14-07-116, filed 3/19/14, effective 4/19/14)
WAC 314-55-083 What are the security requirements for a marijuana licensee?
The security requirements for a marijuana licensee are as follows:
(1) Display of identification badge. All employees on the licensed premises shall be required to hold and properly display an identification badge issued by the licensed employer at all times while on the licensed premises. All nonemployee visitors to the licensed premises, other than retail store customers, shall be required to hold and properly display an identification badge issued by the licensee at all times while on the licensed premises. A log must be kept and maintained showing the full name of each visitor entering the licensed premises, badge number issued, the time of arrival, time of departure, and the purpose of the visit. All log records must be maintained on the licensed premises for a period of three years and are subject to inspection by any liquor control board employee or law enforcement officer, and must be copied and provided to the liquor control board or law enforcement officer upon request.
(2) Alarm systems. At a minimum, each licensed premises must have a security alarm system on all perimeter entry points and perimeter windows. Motion detectors, pressure switches, duress, panic, and hold-up alarms may also be utilized.
(3) Surveillance system. At a minimum, a licensed premises must have a complete video surveillance with minimum camera resolution of 640x470 pixels and cameras must be internet protocol (IP) compatible ((and recording system for controlled areas within the licensed premises and entire perimeter fencing and gates enclosing an outdoor grow operation, to ensure control of the area. The requirements include image acquisition, video recording, management and monitoring hardware and support systems)). All cameras must be fixed and placement shall allow for the clear and certain identification of any person and activities in controlled areas of the licensed premises. All entrances and exits to an indoor facility shall be recorded from both indoor and outdoor, or ingress and egress vantage points. All cameras must record continuously twenty-four hours per day and at a minimum of ten frames per second. The surveillance system storage device must be secured on the licensed premises in a lockbox, cabinet, closet, or secured in another manner to protect from employee tampering or criminal theft. All surveillance recordings must be kept for a minimum of forty-five days on the licensee's recording device. All videos are subject to inspection by any liquor control board employee or law enforcement officer, and must be copied and provided to the liquor control board or law enforcement officer upon request. All recorded images must clearly and accurately display the time and date. Time is to be measured in accordance with the U.S. National Institute Standards and Technology standards.
(a) ((All controlled access areas, security rooms/areas and all points of ingress/egress to limited access areas, all points of ingress/egress to the exterior of the licensed premises, and all point-of-sale (POS) areas must have fixed camera coverage capable of identifying activity occurring within a minimum of twenty feet of all entry and exit points.
(b) Camera placement shall allow for the clear and certain identification of any individual on the licensed premises.
(c) All entrances and exits to the facility shall be recorded from both indoor and outdoor vantage points, and capable of clearly identifying any activities occurring within the facility or within the grow rooms in low light conditions. The surveillance system storage device must be secured on-site in a lock box, cabinet, closet, or secured in another manner to protect from employee tampering or criminal theft.
(d) All perimeter fencing and gates enclosing an outdoor grow operation must have full video surveillance capable of clearly identifying any activities occurring within twenty feet of the exterior of the perimeter. Any gate or other entry point that is part of the enclosure for an outdoor growing operation must have fixed camera coverage capable of identifying activity occurring within a minimum of twenty feet of the exterior, twenty-four hours a day. A motion detection lighting system may be employed to illuminate the gate area in low light conditions.
(e) Areas where marijuana is grown, cured or manufactured including destroying waste, shall have a camera placement in the room facing the primary entry door, and in adequate fixed positions, at a height which will provide a clear, unobstructed view of the regular activity without a sight blockage from lighting hoods, fixtures, or other equipment, allowing for the clear and certain identification of persons and activities at all times.
(f))) Controlled areas include:
(i) Any area within an indoor, greenhouse or outdoor room or area where marijuana is grown, or marijuana or marijuana waste is being moved within, processed, stored, or destroyed. Booms or areas where marijuana or marijuana waste is never present are not considered control areas and do not require camera coverage.
(ii) All point-of-sale (POS) areas.
(iii) Twenty feet of the exterior of the perimeter of all required fencing and gates enclosing an outdoor grow operation. Any gate or other entry point that is part of the required enclosure for an outdoor growing operation must be lighted in low-light conditions. A motion detection lighting system may be employed to light the gate area in low-light conditions.
(iv) Any room or area storing a surveillance system storage device.
(b) All marijuana or marijuana-infused products that are intended to be removed or transported ((from marijuana producer to marijuana processor and/or marijuana processor to marijuana retailer)) between two licensed premises shall be staged in an area known as the "quarantine" location for a minimum of twenty-four hours. Transport manifest with product information and weights must be affixed to the product. At no time during the quarantine period can the product be handled or moved under any circumstances and is subject to auditing by the liquor control board or designees.
(((g) All camera recordings must be continuously recorded twenty-four hours a day. All surveillance recordings must be kept for a minimum of forty-five days on the licensee's recording device. All videos are subject to inspection by any liquor control board employee or law enforcement officer, and must be copied and provided to the board or law enforcement officer upon request.))
(4) Traceability: To prevent diversion and to promote public safety, marijuana licensees must track marijuana from seed to sale. Licensees must provide the required information on a system specified by the board. All costs related to the reporting requirements are borne by the licensee. Marijuana seedlings, clones, plants, lots of usable marijuana or trim, leaves, and other plant matter, batches of extracts, marijuana-infused products, samples, and marijuana waste must be traceable from production through processing, and finally into the retail environment including being able to identify which lot was used as base material to create each batch of extracts or infused products. The following information is required and must be kept completely up-to-date in a system specified by the board:
(a) Key notification of "events," such as when a plant enters the system (moved from the seedling or clone area to the vegetation production area at a young age);
(b) When plants are to be partially or fully harvested or destroyed;
(c) When a lot or batch of marijuana, marijuana extract, marijuana-infused product, or marijuana waste is to be destroyed;
(d) When usable marijuana or marijuana-infused products are transported;
(e) Any theft of usable marijuana, marijuana seedlings, clones, plants, trim or other plant material, extract, infused product, seed, plant tissue or other item containing marijuana;
(f) There is a seventy-two hour mandatory waiting period after the notification described in this subsection is given before any plant may be destroyed, a lot or batch of marijuana, marijuana extract, marijuana-infused product, or marijuana waste may be destroyed;
(g) There is a twenty-four hour mandatory waiting period after the notification described in this subsection to allow for inspection before a lot of marijuana is transported from a producer to a processor;
(h) There is a twenty-four hour mandatory waiting period after the notification described in this subsection to allow for inspection before usable marijuana, or marijuana-infused products are transported from a processor to a retailer;
(i) Prior to reaching eight inches in height or width, each marijuana plant must be tagged and tracked individually, which typically should happened when a plant is moved from the seed germination or clone area to the vegetation production area;
(j) A complete inventory of all marijuana, seeds, plant tissue, seedlings, clones, all plants, lots of usable marijuana or trim, leaves, and other plant matter, batches of extract, marijuana-infused products, and marijuana waste;
(k) All point of sale records;
(l) Marijuana excise tax records;
(m) All samples sent to an independent testing lab, any sample of unused portion of a sample returned to a licensee, and the quality assurance test results;
(n) All free samples provided to another licensee for purposes of negotiating a sale;
(o) All samples used for testing for quality by the producer or processor;
(p) Samples containing usable marijuana provided to retailers;
(q) Samples provided to the board or their designee for quality assurance compliance checks; and
(r) Other information specified by the board.
(5) Start-up inventory for marijuana producers. Within fifteen days of starting production operations a producer must have all nonflowering marijuana plants physically on the licensed premises. The producer must, within twenty-four hours, record each marijuana plant that enters the facility in the traceability system during this fifteen day time frame. No flowering marijuana plants may be brought into the facility during this fifteen day time frame. After this fifteen day time frame expires, a producer may only start plants from seed or create clones from a marijuana plant located physically on their licensed premises, or purchase marijuana seeds, clones, or plants from another licensed producer.
(6) Samples. Free samples of usable marijuana may be provided by producers or processors, or used for product quality testing, as set forth in this section.
(a) Samples are limited to two grams and a producer may not provide any one licensed processor more than four grams of usable marijuana per month free of charge for the purpose of negotiating a sale. The producer must record the amount of each sample and the processor receiving the sample in the traceability system.
(b) Samples are limited to two grams and a processor may not provide any one licensed retailer more than four grams of usable marijuana per month free of charge for the purpose of negotiating a sale. The processor must record the amount of each sample and the retailer receiving the sample in the traceability system.
(c) Samples are limited to two units and a processor may not provide any one licensed retailer more than six ounces of marijuana infused in solid form per month free of charge for the purpose of negotiating a sale. The processor must record the amount of each sample and the retailer receiving the sample in the traceability system.
(d) Samples are limited to two units and a processor may not provide any one licensed retailer more than twenty-four ounces of marijuana-infused liquid per month free of charge for the purpose of negotiating a sale. The processor must record the amount of each sample and the retailer receiving the sample in the traceability system.
(e) Samples are limited to one-half gram and a processor may not provide any one licensed retailer more than one gram of marijuana-infused extract meant for inhalation per month free of charge for the purpose of negotiating a sale. The processor must record the amount of each sample and the retailer receiving the sample in the traceability system.
(f) Producers may sample one gram of usable marijuana per strain, per month for quality sampling. Sampling for quality may not take place at a licensed premises. Only the producer or employees of the licensee may sample the usable marijuana for quality. The producer must record the amount of each sample and the employee(s) conducting the sampling in the traceability system.
(g) Processors may sample one unit, per batch of a new edible marijuana-infused product to be offered for sale on the market. Sampling for quality may not take place at a licensed premises. Only the processor or employees of the licensee may sample the edible marijuana-infused product. The processor must record the amount of each sample and the employee(s) conducting the sampling in the traceability system.
(h) Processors may sample up to one quarter gram, per batch of a new marijuana-infused extract for inhalation to be offered for sale on the market. Sampling for quality may not take place at a licensed premises. Only the processor or employee(s) of the licensee may sample the marijuana-infused extract for inhalation. The processor must record the amount of each sample and the employee(s) conducting the sampling in the traceability system.
(i) The limits described in subsection (3) of this section do not apply to the usable marijuana in sample jars that may be provided to retailers described in WAC 314-55-105(8).
(j) Retailers may not provide free samples to customers.
NEW SECTION
WAC 314-55-103 Good laboratory practice checklist.
A third-party testing lab must be certified by the WSLCB or its vendor as meeting the board's accreditation and other requirements prior to conducting required quality assurance tests. The following checklist will be used by the board or its vendor to certify third-party testing labs:
ORGANIZATION
Document
Reference
Y
N
NA
Comments
1.
The laboratory or the organization of which it is part shall be an entity that can be held legally responsible.
 
 
 
 
 
2.
The laboratory conducting third-party testing shall have no financial interest in a licensed producer or processor for which testing is being conducted.
 
 
 
 
 
a.
If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.
 
 
 
 
 
3.
The laboratory shall have policies and procedures to ensure the protection of its client's confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results.
 
 
 
 
 
4.
The laboratory is responsible for all costs of initial certification and ongoing site assessments.
 
 
 
 
 
5.
The laboratory must agree to site assessments every two years to maintain certification.
 
 
 
 
 
6.
The laboratory must allow WSLCB staff or their representative to conduct physical visits and check I-502 related laboratory activities at any time.
 
 
 
 
 
7.
The laboratory must report all test results directly into WSLCB's traceability system within twenty-four hours of completion. Labs must also record in the traceability system an acknowledgment of the receipt of samples from producers or processors and verify if any unused portion of the sample was destroyed or returned to the customer.
 
 
 
 
 
HUMAN RESOURCES
Document
Reference
Y
N
NA
Comments
8.
Job descriptions for owners and all employees: Key staff.
 
 
 
 
 
9.
Qualifications of owners and staff: CVs for staff on file.
 
 
 
 
 
a.
Have technical management which has overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations.
 
 
 
 
 
b.
Documentation that the scientific director meets the requirements of WSLCB rules.
 
 
 
 
 
c.
Chain of command, personnel organization/flow chart, dated and signed by the laboratory director.
 
 
 
 
 
d.
Written documentation of delegation of responsibilities (assigned under chapter 314-55 WAC as related to quality assurance testing) to qualified personnel, signed and dated by the laboratory director.
 
 
 
 
 
e.
Documentation of employee competency: Prior to independently analyzing samples, testing personnel must demonstrate acceptable performance on precision, accuracy, specificity, reportable ranges, blanks, and unknown challenge samples (proficiency samples or internally generated quality controls). Dated and signed by the laboratory director.
 
 
 
 
 
f.
Designate a quality manager (however named) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the quality system is implemented and followed; the quality manager shall have direct access to the highest level of management at which decisions are made on laboratory policy or resources.
 
 
 
 
 
10.
Written and documented system detailing the qualifications of each member of the staff.
 
 
 
 
 
a.
The need to require formal qualification or certification of personnel performing certain specialized activities shall be evaluated and implemented where necessary.
 
 
 
 
 
11.
Standard operating procedure manual that details records of internal training provided by facility for staff. Laboratory director must approve, sign and date each procedure.
 
 
 
 
 
a.
Instructions on regulatory inspection and preparedness.
 
 
 
 
 
b.
Instruction on law enforcement interactions.
 
 
 
 
 
c.
Information on U.S. federal laws, regulations, and policies relating to individuals employed in these operations, and the implications of these for such employees.
 
 
 
 
 
d.
Written and documented system of employee training on hazards (physical and health) of chemicals in the workplace, including prominent location of MSDS sheets and the use of appropriate PPE.
 
 
 
 
 
e.
Written and documented system on the competency of personnel on how to handle chemical spills and appropriate action; spill kit on-site and well-labeled, all personnel know the location and procedure.
 
 
 
 
 
f.
Information on how employees can access medical attention for chemical or other exposures, including follow-up examinations without cost or loss of pay.
 
 
 
 
 
g.
Biosafety and sterile technique training.
 
 
 
 
 
STANDARD OPERATING PROCEDURES
Document
Reference
Y
N
NA
Comments
12.
As appropriate, laboratory operations covered by procedures shall include but not be limited to the following:
 
 
 
 
 
a.
Environmental, safety and health activities;
 
 
 
 
 
b.
Sample shipping and receipt;
 
 
 
 
 
c.
Laboratory sample chain of custody and material control;
 
 
 
 
 
d.
Notebooks/logbooks;
 
 
 
 
 
e.
Sample storage;
 
 
 
 
 
f.
Sample preparation;
 
 
 
 
 
g.
Sample analysis;
 
 
 
 
 
h.
Standard preparation and handling;
 
 
 
 
 
i.
Post-analysis sample handling;
 
 
 
 
 
j.
Control of standards, reagents and water quality;
 
 
 
 
 
k.
Cleaning of glassware;
 
 
 
 
 
l.
Waste minimization and disposition.
 
 
 
 
 
13.
The following information is required for procedures as appropriate to the scope and complexity of the procedures or work requested:
 
 
 
 
 
a.
Scope (e.g., parameters measured, range, matrix, expected precision, and accuracy);
 
 
 
 
 
b.
Unique terminology used;
 
 
 
 
 
c.
Summary of method;
 
 
 
 
 
d.
Interferences/limitations;
 
 
 
 
 
e.
Approaches to address background corrections;
 
 
 
 
 
f.
Apparatus and instrumentation;
 
 
 
 
 
g.
Reagents and materials;
 
 
 
 
 
h.
Hazards and precautions;
 
 
 
 
 
i.
Sample preparation;
 
 
 
 
 
j.
Apparatus and instrumentation setup;
 
 
 
 
 
k.
Data acquisition system operation;
 
 
 
 
 
l.
Calibration and standardization;
 
 
 
 
 
m.
Procedural steps;
 
 
 
 
 
n.
QC parameters and criteria;
 
 
 
 
 
o.
Statistical methods used;
 
 
 
 
 
p.
Calculations;
 
 
 
 
 
q.
Assignment of uncertainty;
 
 
 
 
 
r.
Forms used in the context of the procedure.
 
 
 
 
 
FACILITIES AND EQUIPMENT
Document
Reference
Y
N
NA
Comments
14.
Allocation of space: Adequate for number of personnel and appropriate separation of work areas.
 
 
 
 
 
15.
Arrangement of space.
 
 
 
 
 
a.
Allows for appropriate work flow, sampling, lab space separate from office and break areas.
 
 
 
 
 
b.
Employee bathroom is separate from any laboratory area.
 
 
 
 
 
16.
Adequate eyewash/safety showers/sink.
 
 
 
 
 
17.
Procurement controls.
 
 
 
 
 
a.
The laboratory shall have procedure(s) for the selection and purchasing of services and supplies it uses that affect the quality of the tests and/or calibrations. Procedures shall exist for the purchase, receipt and storage of reagents and laboratory consumable materials relevant for the tests and calibrations.
 
 
 
 
 
b.
The laboratory shall ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned.
 
 
 
 
 
c.
Prospective suppliers shall be evaluated and selected on the basis of specified criteria.
 
 
 
 
 
d.
Processes to ensure that approved suppliers continue to provide acceptable items and services shall be established and implemented.
 
 
 
 
 
e.
When there are indications that subcontractors knowingly supplied items or services of substandard quality, this information shall be forwarded to appropriate management for action.
 
 
 
 
 
18.
Utilities.
 
 
 
 
 
a.
Electrical:
 
 
 
 
 
i.
Outlets: Adequate, unobstructed, single use, no multi-plug adaptors;
 
 
 
 
 
ii.
No extension cords;
 
 
 
 
 
iii.
Ground fault circuit interrupters near wet areas.
 
 
 
 
 
b.
Plumbing:
 
 
 
 
 
i.
Appropriateness of sink usage: Separate for work/personal use;
 
 
 
 
 
ii.
Adequate drainage from sinks or floor drains;
 
 
 
 
 
iii.
Hot and cold running water.
 
 
 
 
 
c.
Ventilation:
 
 
 
 
 
i.
Areas around solvent use or storage of waste solvent;
 
 
 
 
 
ii.
Vented hood for any microbiological analysis - Class II Type A biosafety cabinet.
 
 
 
 
 
d.
Vacuum:
 
 
 
 
i.
Appropriate utilities/traps for prevention of contamination.
 
 
 
 
 
e.
Shut-off controls: Located outside of the laboratory.
 
 
 
 
 
19.
Waste disposal: Appropriate for the type of waste and compliant with WAC 314-55-097, Marijuana waste disposal—Liquids and solids.
 
 
 
 
 
20.
Equipment list.
 
 
 
 
 
a.
Equipment and/or systems requiring periodic maintenance shall be identified and records of major equipment shall include:
 
 
 
 
 
i.
Name;
 
 
 
 
 
ii.
Serial number or unique identification;
 
 
 
 
 
iii.
Date received and placed in service;
 
 
 
 
 
iv.
Current location;
 
 
 
 
 
v.
Condition at receipt;
 
 
 
 
 
vi.
Manufacturer's instructions;
 
 
 
 
 
vii.
Date of calibration or date of next calibration;
 
 
 
 
 
viii.
Maintenance;
 
 
 
 
 
ix.
History of malfunction.
 
 
 
 
 
21.
Maintenance.
 
 
 
 
 
a.
Regular preventive maintenance of equipment demonstration in logbook including, but not limited to: Thermometer calibration, pipette calibrations, analytical balances, and analytical equipment. Documentation of a schedule and reviewed by the laboratory director.
 
 
 
 
 
b.
Documentation of curative maintenance in logbook, signed and dated by laboratory director.
 
 
 
 
 
c.
Temperature maintenance log book for refrigerators.
 
 
 
 
 
d.
Decontamination and cleaning procedures for:
 
 
 
 
 
i.
Instruments;
 
 
 
 
 
ii.
Bench space;
 
 
 
 
 
iii.
Ventilation hood.
 
 
 
 
 
e.
Documentation of adequacy of training of personnel and responsibility for each maintenance task.
 
 
 
 
 
f.
The organization shall describe or reference how periodic preventive and corrective maintenance of measurement or test equipment shall be performed to ensure availability and satisfactory performance of the systems.
 
 
 
 
 
22.
Computer systems.
 
 
 
 
 
a.
Adequate for sample tracking.
 
 
 
 
 
b.
Adequate for analytical equipment software.
 
 
 
 
 
c.
Software control requirements applicable to both commercial and laboratory developed software shall be developed, documented, and implemented.
 
 
 
 
 
d.
In addition, procedures for software control shall address the security systems for the protection of applicable software.
 
 
 
 
 
e.
For laboratory-developed software, a copy of the original program code shall be:
 
 
 
 
 
i.
Maintained;
 
 
 
 
 
ii.
All changes shall include a description of the change, authorization for the change;
 
 
 
 
 
iii.
Test data that validates the change.
 
 
 
 
 
f.
Software shall be acceptance tested when installed, after changes, and periodically during use, as appropriate.
 
 
 
 
 
g.
Testing may consist of performing manual calculations or checking against another software product that has been previously tested, or by analysis of standards.
 
 
 
 
 
h.
The version and manufacturer of the software shall be documented.
 
 
 
 
 
i.
Commercially-available software may be accepted as supplied by the vendor. For vendor supplied instrument control/data analysis software, acceptance testing may be performed by the laboratory.
 
 
 
 
 
23.
Security.
 
 
 
 
 
a.
Written facility security procedures during operating and nonworking hours.
 
 
 
 
 
b.
Roles of personnel in security.
 
 
 
 
 
c.
SOP for controlled access areas and personnel who can access.
 
 
 
 
 
d.
Secured areas for log-in of sample, and for short and long-term storage of samples.
 
 
 
 
 
24.
Storage.
 
 
 
 
 
a.
Appropriate and adequate for sample storage over time. The laboratory shall monitor, control and record environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic disturbances, humidity, electrical supply, temperature, and sound and vibration levels, as appropriate to the technical activities concerned.
 
 
 
 
 
b.
Adequate storage of chemical reference standards.
 
 
 
 
 
c.
Appropriate storage of any reagents: Fireproof cabinet, separate cabinet for storage of any acids.
 
 
 
 
 
d.
Appropriate safe and secure storage of documents etc., archiving, retrieval of, maintenance of and security of data for a period of three years.
 
 
 
 
 
QA PROGRAM AND TESTING
Document
Reference
Y
N
NA
Comments
25.
Sampling/sample protocols: Written and approved by the laboratory director.
 
 
 
 
 
a.
Demonstrate adequacy of the chain-of-custody tracking upon receipt of sample including all personnel handling the sample.
 
 
 
 
 
b.
Sampling method (representative of an entire batch) including, but not limited to, homogenization, weighing, labeling, sample identifier (source, lot), date and tracking.
 
 
 
 
 
c.
Condition of the sample: Macroscopic and foreign matter inspection - Fit for purpose test. Scientifically valid testing methodology: Either AHP monograph compliant, other third-party validation.
 
 
 
 
 
d.
Failed inspection of product: Tracking and reporting.
 
 
 
 
 
e.
Return of failed product documentation and tracking.
 
 
 
 
 
f.
Disposal of used/unused samples documentation.
 
 
 
 
 
g.
Sample preparation, extraction and dilution SOP.
 
 
 
 
 
h.
Demonstration of recovery for samples in various matrices (SOPs):
 
 
 
 
 
i.
Plant material - Flower;
 
 
 
 
 
ii.
Edibles (solid and liquid meant to be consumed orally);
 
 
 
 
 
iii.
Topical;
 
 
 
 
 
iv.
Concentrates.
 
 
 
 
 
26.
Data protocols.
 
 
 
 
 
a.
Calculations for quantification of cannabinoid content in various matrices - SOPs.
 
 
 
 
 
b.
Determination of the range for reporting the quantity (LOD/LOQ) data review or generation.
 
 
 
 
 
c.
Reporting of data: Certificates of analysis (CA) - Clear and standardized format for consumer reporting.
 
 
 
 
 
d.
Documentation that the value reported in the CA is within the range and limitations of the analytical method.
 
 
 
 
 
e.
Documentation that qualitative results (those below the LOQ but above the LOD) are reported as "trace," or with a nonspecific (numerical) designation.
 
 
 
 
 
f.
Documentation that the methodology has the specificity for the degree of quantitation reported. Final reports are not quantitative to any tenths or hundredths of a percent.
 
 
 
 
 
g.
Use of appropriate "controls": Documentation of daily use of positive and negative controls that challenge the linearity of the curve; and/or an appropriate "matrix blank" and control with documentation of the performance for each calibration run.
 
 
 
 
 
27.
Chemical assay procedure/methodology.
 
 
 
 
 
28.
Proficiency:
 
 
 
 
 
a.
Documentation of use of an appropriate internal standard for any quantitative measurements as applicable to the method.
 
 
 
 
 
b.
Appropriate reference standards for quantification of analytes, performing and documenting a calibration curve with each analysis.
 
 
 
 
 
c.
Demonstration of calibration curve r2 value of no less than 0.995 with a minimum of four points within the range.
 
 
 
 
 
d.
Documentation of any proficiency testing as it becomes available. Laboratory director must review, evaluate and report to the WSLCB any result that is outside the stated acceptable margin of error.
 
 
 
 
 
29.
Method validation: Scientifically valid testing methodology: Either AHP monograph compliant, other third-party validation; or
 
 
 
 
 
30.
Level II validation of methodology used for quantification of THC, THCA and CBD for total cannabinoid content (if reporting other cannabinoids, the method must also be validated for those compounds):
 
 
 
 
 
a.
Single lab validation parameters are demonstrated for GC, HPLC data review:
 
 
 
 
 
i.
Linearity of reference standards;
 
 
 
 
 
ii.
Use of daily standard curve;
 
 
 
 
 
iii.
Accuracy;
 
 
 
 
 
iv.
Precision;
 
 
 
 
 
v.
Recovery (5 determinations not less than 90%);
 
 
 
 
 
vi.
Reproducibility over time within a relative standard deviation of 5%.
 
 
 
 
 
b.
Dynamic range of the instrumentation: Limits of quantification (LOQ) and limits of detection (LOD).
 
 
 
 
 
c.
Matrix extensions for each type of product tested, data review of recovery for:
 
 
 
 
 
i.
Solvent-based extract;
 
 
 
 
 
ii.
CO2 extraction or other "hash oil";
 
 
 
 
 
iii.
Extract made with food grade ethanol;
 
 
 
 
 
iv.
Extract made with food grade glycerin or propylene glycol;
 
 
 
 
 
v.
Infused liquids;
 
 
 
 
 
vi.
Infused solids;
 
 
 
 
 
vii.
Infused topical preparations;
 
 
 
 
 
viii.
Other oils, butter or fats.
 
 
 
 
 
d.
Presence of QC samples and recording of daily testing.
 
 
 
 
 
e.
Appropriate use of an internal reference standard.
 
 
 
 
 
f.
Daily monitoring of the response of the instrument detection system.
 
 
 
 
 
31.
Other methods.
 
 
 
 
 
a.
Microbiological methods fit for purpose.
 
 
 
 
 
b.
Microbial contaminants within limits of those listed in the most recent AHP monograph and otherwise directed by WSLCB.
 
 
 
 
 
c.
Moisture content testing fit for purpose. Scientifically valid testing methodology: Either AHP monograph compliant, other third-party validation.
 
 
 
 
 
d.
Solvent residuals testing fit for purpose; solvent extracted products made with class 3 or other solvents used are not to exceed 0.5% residual solvent by weight or 500 parts per million (PPM) per one gram of solvent based product and are to be tested.
 
 
 
 
 
e.
Any other QA/QC methods is proven to be fit for purpose.
 
 
 
 
 
32.
Laboratory notebooks.
 
 
 
 
 
a.
Legible and in ink (or computerized system).
 
 
 
 
 
b.
Signed and dated.
 
 
 
 
 
c.
Changes initialed and dated.
 
 
 
 
 
d.
Periodically reviewed and signed by a management representative.
 
 
 
 
 
33.
Preventive/corrective action.
 
 
 
 
 
a.
The laboratory shall have a process in place to document quality affecting preventive/corrective actions through resolution.
 
 
 
 
 
34.
Periodic management review.
 
 
 
 
 
a.
Laboratory management shall periodically review its quality system and associated procedures to evaluate continued adequacy. This review shall be documented.