Commercial Cannabis Business Licensing Program · PDF filetesting and quality assurance of cannabis goods. ... analyzed for residual solvents. The regulations will provide a table

Bureau of Cannabis ControlC A L I F O R N I A D E P A R T M E N T O F C O N S U M E R A F F A I R S

1625 North Market Boulevard, Suite S-202Sacramento, CA 95834

Contact: Sara [email protected]

Bureau of Cannabis Control

Commercial CannabisBusiness Licensing Program RegulationsInitial Study/Negative Declaration

September 6, 2017

2. Proposed Program Description

TransportationThe Bureau’s regulations will detail safety and security provisions that distributors mustcomply with when transporting cannabis or cannabis products. Cannabis goods will be required to be transported inside commercial vehicles or trailers. Transportation may not bedone by aircraft, watercraft, rail, drones, human powered vehicles, or unmanned vehicles.Distributor licensees will be required to submit proof of ownership or a valid lease, proof ofinsurance, and identifying information for any vehicles that will be used for transportingcannabis goods. Additionally, license applicants must submit proof of insurance in an amountspecified by the Bureau for any and all commercial vehicles that will be used for transportactivities.

Vehicles used for transporting cannabis goods must contain a box that can be locked and that is secured to the inside of the vehicle or trailer. Cannabis goods must be locked in the boxduring transport. The vehicle and/or trailer must be locked and secured when leftunattended. Thevehiclemaynot be left unattended or parked overnight in a residential area ifitcontains cannabisgoods.

Only licensed distributors and their employees may be in a commercial vehicle while transportingcannabis.Onlypersons aged21years oroldermay beinthetransportvehicle.

Distributorswill be required to completeand transmit shipping manifests tothe Bureauandthe licensee receiving the shipment for every shipment prior to transport. Bureau regulationswill detail the information required in shipping manifests. The regulations also specifydistribution‐specific records that must be kept by distributors. Distributors also will berequiredtoenterrequiredinformation regardingtransportshipments into the State’s track‐and‐tracedatabase.

Testing and Quality AssuranceThe regulations will describe the responsibilities of licensed distributors with respect to the testing and quality assuranceof cannabisgoods.

After taking physical possession of a cannabis batch, a distributor will contact a licensed testing laboratory to arrange for testing, unless the distributor plans to sell the batch toanother distributor. At that point, a laboratory agent will come to the distributor’s licensed premises to take a sample. The sample selection will be recorded on video, and both the distributorandthelaboratoryagent mustwitnessandattestto the sample selection.

After the sample has been tested, the testing laboratory will provide the distributor with a certificate of analysis. If a sample passes testing, the distributor may transport the cannabis goods to one or more retailers for sale. If a harvest batch fails testing, it can be remediated foruseinamanufacturedproduct,if doingso wouldnotresult inharmtoconsumers.

The distributor will complete several quality assurance steps before distributing the batchfor sale. The distributor must check that the certificate of analysis corresponds to the batchtested; the label is accurate; the packaging meets required standards; and the properinformation isinthe State’strack‐and‐tracedatabase.

Bureau of Cannabis Control Commercial Cannabis Business Licensing Program

2-6 September 2017 Project No. 16.044

Initial Study/Negative Declaration

2.2 Summary of Expected Emergency MAUCRSA Regulations

2.2.3 Distributors

Cont…


Other RequirementsThe Bureau will detail additional requirements for retailers. Retailers must enter requiredinformation concerning receipt, sales, and returns of cannabis goods into the State’s track‐and‐trace database. In addition, retailers are required to notify law enforcement within 24 hours if they identify a discrepancy in their inventory or if they have reason to suspect diversion,theft,orother criminalactivity.

The Bureau’s regulations will include a grace period for compliance with packaging andtesting requirements. During the grace period, retailers may package and sell cannabis goods that have not been packaged by a cultivator ordistributor.In addition,during the same timeframe, retailers may sell untested cannabis if they place a label on the package with the date of purchase and the statement, “This product has not been tested under the Medicinal and Adult‐UseCannabis RegulationandSafetyAct.”

2.2.5 Testing Laboratories

The Bureau’s regulations will require that in addition to the regulations that apply to all Bureau licensees, summarized above in Section 2.2.2, cannabis testing laboratories must complywiththeadditionalrequirementssetforthinitslaboratory regulations.

Chapter DefinitionsThe regulations will define key terms used throughout the laboratory testing regulations. For example, terms such as “primary sample,” “quality‐control sample,” and “proficiency testsample” will be clearly defined to clarify for the reader how the Bureau regulates samplingand testing procedures. Various cannabis‐specific terms, such as “cannabinoid,” “CBD,”“CBDA,” and “hashish,” will be defined to assist the reader in understanding usage of cannabisterminology in the context of the regulations. In addition, technical testing terms such as “matrixspikesample,”“method blank,”and“actionlevel”will be definedforthereader.

License ApplicationThe regulations will contain provisions regarding testing laboratory license applications. Inaddition to the standard licensing requirements described above in Section 2.2.2, laboratories will be required to submit additional information, including proof ofInternational Organization for Standardization (ISO) 17025 accreditation or proof that the applicant is in the process of applying for accreditation, laboratory employee qualifications,standard operating procedures, and a premises diagram containing a description of theactivitiesthattake placeineachspace.

Sampling of Cannabis GoodsThe regulations governing sampling of cannabis goods will describe the processes andstandards for selecting, gathering, storing, preparing, and analyzing samples of cannabisgoods. The regulations will require licensed laboratories to develop and implement sampling plans that must be approved by the laboratory director and made available to all laboratory personnel.




Cont…


Laboratory personnel will be required to keep a detailed field log for recording information during sampling events. The log must contain information regarding the sampling laboratory, distributor, sample taken, and conditions under which the sample was taken. In addition, laboratories will be required to develop and implement a chain‐of‐custody protocol to ensure accurate documentation of the transport, handling, storage, and destruction of cannabis samples.

The regulations will detail requirements for sampling procedures for unpackaged harvestbatches and for packaged cannabis goods. For each of these categories, the regulations willspecify the requirements for collecting samples, the sample size, and the number of sampleincrements.. The regulations also will require that laboratory personnel collect a duplicate fieldsample inadditionto the primary sample.

Finally, the regulations will detail various factors that may cause a sample to be rejected. Some of the factors that may cause a laboratory to deem a sample “compromised” andtherefore reject it, include a broken shipping container; evidence that the sample has been tampered with, adulterated, or contaminated; a missing or incomplete chain‐of‐custody form orfieldlog; orindications thatthetemperatureof the sample is out of the required range.

Standard Operating ProceduresThe regulations will require testing laboratories to develop, implement, and maintain standard operating procedures for distinct aspects of their operations, including laboratoryprocesses, analytical methods, and testing methodologies. For laboratory processes, the standard operating procedure will include items such as calibration and maintenance ofequipment and instruments; chain‐of‐custody protocols; employee training; security;recordkeeping; and sample preparation, storage, and disposal. The standard operatingprocedures for analytical methods will describe how the laboratory performs each testingmethod. The procedures will include elements such as lists of analytes; applicable matrices; method sensitivity; potential interferences; analytical instruments; consumable supplies,reagents, and standards; sample preservation and hold time; types, frequency, andacceptance criteria for quality control samples and calibration standards; and calculation ofresults. For testing methodologies, the standard operating procedures must conform to a valid testing methodology guideline such as the U.S. Food and Drug Administration’s Bacterial Analytical Manual (2016) or AOAC International’s Official Methods of Analysis for Contaminant Testing of AOAC International (2016). Laboratories may use nonstandard methodsif theyarevalidatedin accordancewiththeprocesses setoutintheseregulations.

Laboratory Analyses and ReportingThe regulations will define the types of analyses that testing laboratories must perform for samples. These include analyses for cannabinoids, contaminants such as filth, and foreign material,andwater activity.

Laboratories will be required to test samples for cannabinoid content. The cannabinoids thatare required to be tested for are tetrahydrocannabinol (THC), tetrahydrocannabinolic acid(THCA), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabigerol (CBG), and cannabinol(CBN). For each of these cannabinoids, laboratories must report the concentration. They mayalsotestforothercannabinoids at theelection of thetest requester.





Laboratories will be required to analyze samples of manufactured cannabis goods for residual solvents and processing chemicals. Dried flower, kief, and hashish need not be analyzed for residual solvents. The regulations will provide a table of residual solvents and“action levels” for cannabis goods. In the table, action levels will be specified for products intended for inhalation, as well as for cannabis–infused goods. Laboratories must report the solvents and processing chemicals listed in this table in parts per million. Detection ofsolvents or processing chemicals above the action levels will result in failure for testing purposes.

Testing laboratories will be required to test samples for residual pesticides. The regulations will provide a list of pesticides that must be tested for, as well as maximum amounts ofpesticide residues that may be found in edible cannabis products, dried cannabis flowers, andall other processed cannabis, in parts per million. If a testing laboratory detects pesticidelevelshigher than the regulations allow,thesamplefailstesting.

Laboratories will be required to test samples of cannabis and cannabis products formicrobiological impurities, which will include Shiga toxin–producing Escherichia coli and Salmonella spp. Laboratories must also test for the pathogenic species Aspergillus funigatus, A. flavus, A. niger, and A. terreus in all cannabis goods intended for consumption by inhalation, including dried flower, kief, hashish, oil, and waxes. Samples containing these microbiological impuritiesabove the detectionlimitwillbedeemedtofailmicrobiologicalimpuritytesting.

Testing laboratories will be required to analyze samples for mycotoxins. The regulations will specify maximum levels for mycotoxins. The laboratory may test for additional microorganisms if a customer so requests. Samples that exceed the levels specified in the regulationsfailmycotoxintesting.

Testing laboratories will analyze dried flower harvest batch samples for water activity andmoisture content. Samples that do not meet the regulatory standard and fail water activityand/or moisture content testing may be returned to the cultivator for further drying and curing.Allrequiredtestingof theharvestbatch wouldthenneed tobe repeated.

Testing laboratories will be required to test samples for filth and foreign material. Thisincludes, but is not limited to, mold, hair, insects, feces, packaging contaminants, andmanufacturing waste and byproducts. Samples that contain these contaminants above thespecifiedactionlevelswill faillaboratorytesting.

Laboratories may be required to analyze samples for concentrations of heavy metals.Samplestestedfor heavy metalswillpasstestingif theconcentrations of these heavy metals arebelowtheaction levelsspecifiedfortheparticularproduct.

If a cultivator’s, manufacturer’s, or distributor’s product labeling says that the samplecontains discrete terpenes, the laboratory will be required to test for those terpenes and report their concentration. The requester of the laboratory test may also request measurementofspecificterpenes.

After completion of testing, the testing laboratory will issue a certificate of analysis thatdetails the results of each test. The certificate of analysis will also report whether thelaboratorydetected any unknownor unidentified substances ormaterials during analysis ofa sample. If the laboratory finds a contaminant that is not listed in these regulations that could





be injurious to human health at the levels detected, the laboratory must notify the Bureau within 24 hours. Samples found to contain synthetic cannabinoids will fail testing. Thecertificate of analysis will also state whether the sample passed or failed testing. If the sample passes testing, the laboratory will enter that information into the track‐and‐trace database, andthebatchfromwhichthesample wastaken may be releasedfor retail sale. Ifthe sample fails testing, the laboratory will upload a copy of the certificate of analysis into the track‐and‐tracedatabase.

Post‐Testing ProceduresThe regulations will specify post‐testing procedures for instances where a batch fails testing.A batch may not be retested unless it has undergone a remediation process. Before a batch can be retested, the distributor must provide a document to the laboratory specifying how theproductwasremediated.

Testing laboratories will be required to destroy nonhazardous waste from cannabis samplesaccording to specific destruction provisions. Additionally, as with all licensees, testinglaboratories must dispose of hazardous waste containing cannabis in accordance with applicable federalandStatehazardous wastelaws.

Quality Assurance and Quality ControlTesting laboratories will be required to develop and implement a laboratory quality assuranceprogramthat includesthefollowingitems: qualitycontrolprocedures;laboratory organization andpersonnel;qualityassuranceobjectivesformeasurementdata;traceabilityof data and analytical results; equipment preventive maintenance; equipment calibration;performance and system audits and corrective action; quality assurance recordkeeping;standardizationoftestingprocedures;andmethodvalidation.

Laboratories will also be required to run quality control samples as specified by the Bureau. The regulations will detail parameters for using method blank samples, field duplicate samples,matrixspikesamples,andreference material.

Testing laboratories will be required to calculate the limits of detection and the limits ofquantitation for quantitative analytical methods. Laboratories can use signal‐to‐noise ratio, the standard deviation of the response and the slope of the calibration curve, or another method published by the U.S. Food and Drug Administration or the U.S. Environmental ProtectionAgency.

The regulations will require the testing laboratory to prepare a data package for each batch of samples it analyzes. The data package will contain identifying information about the laboratory and the personnel that performed the analysis, sample and quality control sampleresults,rawdataforeachsample,instrument test methodwith parameters,instrumenttunereport, calibration data, test method worksheets, quality control report, analytical batchsample sequence, field sample log and chain‐of‐custody forms, and certificate of analysis. The laboratory director will review and verify the analyses in the data package and approve the results.

The regulations will specify a series of requirements for laboratories to perform proficiencytesting. Laboratories that cannot demonstrate successful performance in the required





proficiency testing must take and document corrective actions. Failure to participate in a proficiencytestmayresultindisciplinaryaction.

Testing laboratories will conduct an internal audit at least annually, or as required by the ISOaccreditingbody.AuditresultsmustbesubmittedtotheBureau.

Laboratories are required to maintain records relating to the following categories for a minimum of seven years: personnel qualifications; method verification and validation;quality control and quality assurance; chain of custody; purchasing and supply; installation, maintenance, and calibration of laboratory equipment; customer service; nonconforming work and corrective action; internal and external audits; management review; laboratory data reports, data review, and data approval; proficiency testing; electronic data and security; data on traceability, raw data, calibration, and log books; and laboratory contamination and cleaning.

Employee Education and Experience RequirementsThe regulations will outline the minimum qualifications and training required for specific employment positions at testing laboratories. The regulations will require that laboratoriesverifyandmaintaindocumentationofemployees’qualifications.

Premises SecurityCertain security requirements will be imposed on testing laboratories. Security provisionsapplying to all licensed commercial cannabis business premises are described above inSection2.2.2;the regulationswilldetailadditional security provisionsthatapplyspecifically to testing laboratories. In addition to the security provisions applicable to all licensed cannabis businesses, the regulations will provide that laboratories must implement an accesscontrol card system through all access control points that records the transaction history ofentrants. Laboratories must also maintain a log of visitors. Laboratories must have secured storage for test samples; cannabis waste; reference standards for analysis of cannabinoids;controlled substances related to cannabinoids; and records of analytical tests, includingcertificates of analysis and data packages. Additionally, laboratories must implement password protection for electronically stored data. Laboratories must notify the Bureau inthe event of unexplainedlossesofcannabisorcannabisproduct samples.

2.2.6 Microbusiness

A microbusiness license allows the licensee to cultivate cannabis in an area of less than 10,000 square feet and to act as a licensed distributor, Level 1 (nonvolatile solvent) manufacturer, and retailer. (Bus. & Prof. Code §26070.) For both medicinal and adult‐use cannabis operations, CDFA is the licensing authority for stand‐alone cannabis cultivation activities and CDPH is the licensing authority for stand‐alone cannabis manufacturing activities.

With regard to distribution and retail sale, the regulations applicable to those activities are anticipated to be the same for a microbusiness as for a standalone business. For cultivationactivities, it is expected that applicants will be required to follow applicable provisions of thecultivation regulations that will be adopted by CDFA for cannabis cultivation, and CDFA is




3. Proposed Program Activities

3.5 Cannabis Testing Laboratory Operations The Bureau has licensing authority for cannabis testing laboratories under MAUCRSA. Laboratories licensed by the Bureau will conduct quality assurance testing on both medicinaland adult‐use cannabis. This discussion provides information regarding the operational activities and regulatory requirements set out in MAUCRSA for cannabis testing laboratories. Before the enactment of MAUCRSA, State law contained no requirement for cannabis and cannabis products to be tested at any stage of the production process. Voluntary testing hasbeen conducted in some instances, however, and various laboratories around the statecurrently offer cannabis testing. Some existing medicinal cannabis dispensaries provideconsumers with laboratory analysis information regarding their cannabis products. As anexample, cannabis products sold at dispensaries are typically labeled with cannabinoid andTHC content because different cannabinoid and THC content can have different effects onpatients and their symptoms. In addition, some local jurisdictions, such as the City of Berkeley and others, have adopted local testing requirements or rely on testing standards from other states (e.g., Oregon) as testing benchmarks. Because no specific testing standard has beenadopted statewide or is otherwise widely accepted, results can vary greatly betweenlaboratories depending ontheproceduresandequipmentused.Additionally,thesubstancesorcontaminantsforwhich laboratoriesaretestingcanvarywidely.

MAUCRSA requires that, following the harvest of cannabis flower by a licensed commercialcultivator or the manufacture of cannabis products by a licensed manufacturer, arepresentative sample of each batch of cannabis and cannabis products must be tested by alicensed testing laboratory for compliance with regulatory standards before those items can be distributed to a retailer for sale to consumers. Live plants and seeds are excluded from this testing requirement. The testing laboratory must test samples for specific components required bytheBureau,aswell as for thepresenceofprohibitedlevelsofpesticides,solventresidues, and other adulterants (e.g., mold). Specific testing requirements are described inmoredetailbelow.

3.5.1 General Operational Activities

Laboratories analyze raw cannabis flower, concentrates, infused products (such as edibles and tinctures), capsules, patches, topicals, and anyother commercial cannabis products that contain active cannabinoids and are intended for consumer sales. Cannabis product types are definedanddescribedfurtherin Section3.5.2,“TypicalCannabisProducts.”

Some laboratories also offer services such as genetic testing and consulting on other issues,including labeling, marketing, packaging, processing, and compliance with State and locallaws, regulations, and ordinances. Web‐based tools for viewing testing results and reportssummarizing the results may be offered to customers. Laboratories offering these servicesmay test cannabis and cannabis products exclusively, or they may test other products,includingfood.

Currently, samples are transported and delivered to testing laboratories in an inconsistentand unregulated manner. Under the Bureau’s Proposed Program, the testing process wouldbegin when personnel from a licensed testing laboratory arrive at a distributor’s licensedfacility to take product samples. Samples must be placed in sample containers meeting

Bureau of Cannabis Control 3-12 September 2017 Commercial Cannabis Business Licensing Program Project No. 16.044 Initial Study/Negative Declaration

3.1 Overview of Licensed Cannabis Business OperationsCont…


specific requirementsand sealed with a tamper‐evident seal.The laboratory personnel mustalso complete a field log for each sampling event to help ensure accurate recordkeeping andchain‐of‐ custody. Samples are then placed into a tamper‐evident portable storage unit for transport. The portable storage unit for cannabis flowers must be kept at an appropriate temperature.

At the laboratory, employees must ensure that the sample is handled according to thefacility’s chain‐of‐custody protocols by assigning the sample an individual trackingidentification number and logging information regarding each sample increment into a database. Laboratory technicians process the sample to prepare it for testing. For flowers, laboratory technicians typically grind the sample into a powder. During preparation forsubsequent analyses, the sample is typically extracted with solvents to concentrate particularanalytes (e.g., CBD, terpenes, pesticides, solvents) (see Section 3.5.4, “Methods for Analysis”). For bacterial, mold, and fungal testing, the sample is plated directly into a Petri dish. The Bureau would require that, following the completion of testing, samples must be destroyed inaccordance withrequireddisposalprocedures.

After all required and requested testing is completed, the distributor or other entity requesting testing would receive a certificate of analysis from the laboratory. The certificate of analysis would contain all results from testing, including cannabinoid and terpene content and contaminants, as required by regulation. In addition, the certificate of analysis would indicate whether the sample “passes” or “fails” testing. Passing means that the analysis of the sample did not report any analyte above its allowable maximum action level. Failing means that the analysis of a sample reported one or more analytes above their respective allowablemaximum action levels. If a sample passes testing, the batch may be sold to consumers at aretailer. If a sample fails testing, it may not be sold to consumers. If a failed batch can be manufactured into a product that is safe for consumers, the distributor may arrangeforsuch manufacture. Ifnot,the batchmustbedestroyedinaccordance withalldisposalprocedures.

To procure a testing license from the Bureau, a laboratory must meet certain general criteria.MAUCRSA requires that testing laboratories use standard operating procedures, includingmethods consistent with the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) 17025 standards4 (Bus. & Prof. Code §26100[g]). In addition, the laboratory must be accredited by an independent accrediting body(Bus.& Prof.Code§26001[as][1]).

Laboratories must also meet additional requirements to receive a testing license.Laboratories must develop and implement protocols for taking and handling of samples,testing procedures, quality assurance measures, recordkeeping, proficiency testing, andinternal audit. In addition, the regulations specify personnel qualifications and explicittrainingrequirementsforlaboratoryemployees.

4 ISO is an independent, non‐governmental organization that creates international standards for products,services, and systems. ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. The standard covers testing and calibration performed usingstandard methods, nonstandard methods, and laboratory‐developed methods. It is applicable to allorganizations performing tests and/or calibrations, including laboratories where testing and calibration are part ofinspection and product certification.



3.5.2 Substances Requiring Analysis

MAUCRSA requires that laboratories test for several types of substances. Specifically, MAUCRSA requires that laboratories confirm that the chemical profile of a sample matches the lot specifications with regard to levels of the following compounds and contaminants (Bus.&Prof. Code§26100[d]):

� cannabinoids; � terpenes and terpenoids; � solventsor processingchemicals; � residualpesticides; � microbiologicalimpurities,asidentified bytheBureau inregulation; � foreign materials, including (but not limited to) hair, insects, and similar or related

adulterants;and

� various other compounds or contaminants (mycotoxins, moisture content, and heavy metals).

Eachcategoryisdescribedinmoredetailbelow.

Cannabinoids Cannabinoids are a group of chemical compounds that occur naturally in cannabis plants.5Although more than 60 cannabinoids have been identified, two have been well characterized forthe discussion of medicinaland adult‐use cannabis usage: tetrahydrocannabinol (THC), a major psychoactive component of cannabis, and cannabidiol (CBD) cannabinoids, found naturally in cannabis plants but known to have limited or no psychotropic effects. In additionto other plant breeding considerations, cannabis plant strains have been bred to contain“high” or elevated amounts of either of these cannabinoids for greater potency. The presence of THCandCBDis expressedas a percentageof thetotal cannabinoidsin acannabis sample;as an example, high‐THC strains generally contain THC levels greater than 20 percent (Leafly 2016). Because many popular cannabis strains have little to no CBD, strains are considered to have high CBD if the levels are greater than 4 percent (Leafly 2016). CBD is believed to have a range of medicinal effects, including anti‐inflammatory and analgesic effects. CBDlevels may be much higher (approximately 15percent or more) in specially bred cannabisstrains intended for medicinal use (GrowWeedEasy 2016a). The final amounts of THC and CBDinprocessedcannabis budsislargelydeterminedby genetics(GrowWeedEasy2016a).

In addition to testing for THC and CBD, MAUCRSA requires laboratories to test for the followingcannabinoids(Bus. &Prof. Code§26100[d]).

5 Cannabinoids have also been found to occur naturally in humans as endocannabinoids and can also be created synthetically(GWPharmaceuticals2016).



Tetrahydrocannabinolic acid (THCA) is the acid form of THC. THCA occurs naturally inthecannabis plant.When heated,itdecarboxylatestocreate THC.

Cannabidiolic acid (CBDA) is the main form in which CBD exists in the cannabis plant. CBD is obtained through non‐enzymatic decarboxylation from the acidic form of thecannabinoid, which takes place when the compounds are heated. Heating or catalyzingCBDAtransformsitintoCBD,therebyincreasingthetotalCBDlevel.

Cannabigerol (CBG) is a non‐psychoactive cannabinoid commonly found in cannabis. CBG acid is the precursor to both THCA and CBDA in the plant, usually found at low levels (lessthan1percent)whenpresent.

Cannabinol (CBN) is a mildly psychoactive cannabinoid that is produced from the degradation of THC.Thereisusuallyverylittleto noCBNin a freshplant.

Terpenes and TerpenoidsTerpenes are volatile aromatic molecules, or oils, that are produced in the cannabis plant’sresin6 glands, evaporate easily, and are responsible for most of the scents and smellsassociated with cannabis plants (Alchimia Blog 2014). Terpenes were developed in the plants to lure pollinators, repel fungus, and serve as a defense mechanism against predators(Alchimia Blog 2014, Rahn 2014, ProjectCBD 2016). Factors that may affect a cannabis plant’sterpene development include climate, weather, age and maturation, fertilizers, and soil type (Rahn 2014).

More than 100 typesof terpenes exist,and each cannabisstrain has a uniqueterpeneprofile (Alchimia Blog 2014). The primary terpenes found in cannabis are A‐pinene, Linalool,BetaCaryophyllene, Myrcene, and Limonene. Terpenes, or terpenoids, can be found in a variety of other plants. For example, these primary five terpenes are also found in pine needles,lavender,blackpepper, hops, andcitrus,respectively (AlchimiaBlog2014).

The Bureau does not require laboratories to test for any specific terpenes or to test generallyfor terpenes unless the client requests such testing or the product label indicates that the cannabisorcannabisproduct contains discreteterpenes.

Solvents or Processing ChemicalsTo manufacture cannabis products such as oils and concentrates, manufacturers may use solvents such as butane or other processing chemicals to extract cannabinoids and other chemical compounds from cannabis plant material. Some of the resulting products contain variousconcentrationsofthese solventsorprocessingmaterials.

6 Resin is a natural organic substance formed in plants that can be used to make various products. In the case of cannabis, resin glands (trichomes) are the plant structures that primarily contain the cannabinoids and terpenes(Green2016).



One commonly sold class of cannabis products created using solvents isBHO. To make BHO, pressurized butane is forced through a vessel containing cannabis flowers, trim, and/or kief.7Cannabinoids, terpenes, and flavonoids are preferentially removed by the butane and resultin an oil. The butane‐rich oil is then left exposed or is placed in a vacuum oven to evaporate the butane. The consistency of BHO products varies depending on cannabis quality, strain, and post‐extraction processes. BHO is often mixedwith glycol to enhanceviscosity for use invaporizer cartridges. BHO can then be stored and smoked (HIIMR 2017). Some butane may remain intheproductfollowingthemanufacturingprocess.

Laboratories may find other types of industrial solvents in cannabis products, which may be byproducts of manufacturing or unintentionally present – such as processing solvents, contaminants in the processing solvents, or residue from an industrial cleaner used to clean equipment. The Bureau’s implementing regulations will require testing laboratories to test for solvents or processing chemicals, which are expected to include the following (the final listmay includesomedifferentchemicals):

1,2‐Dichloroethane Ethylether Pentane Acetone Ethyleneoxide Petroleumether Acetonitrile Heptane Propane Benzene Hexane Trichloroethylene Butane Isopropylalcohol TolueneChloroform Methanol TotalxylenesEthanol Methylene chloride (ortho‐,meta‐,para‐)Ethylacetate Naphtha

Residual Pesticides Cannabis cultivation may be affected by pests (BOTEC Analysis Corporation 2013). Pests maybe transported to cannabis cultivation locations during delivery of cannabis cultivationmaterialssuchas cuttings,soil, orplants,or onworkers’clothingor shoes, ormay occuras aresult of climatic growing conditions (e.g., humidity or temperature). In addition, pests such as gophers or deer may travel to a cultivation site. Reportedly, more than 250 insects and mite pests have been associated with cannabis plants (Medical Marijuana 2016). Potentialcommon pests affecting cannabis plants include, but are not limited to, mites (e.g., spider, russet, broad, and cyclamen), white flies, fungus gnats, root aphids, thrips, powdery mildew,fungus, pond mildew/botrytis, deer, rats, squirrels, and gophers. Growers sometimes applyprophylactic pesticide treatments for difficult pests that are not detectable with the nakedeye,such as mites.

The Bureau’s regulations will require testing laboratories to test for specific pesticides, which areexpected toincludethefollowing(thefinallistmayincludesomedifferentpesticides):

7 Kief is the resin glands of cannabis that may accumulate in containers or be sifted from loose, dry cannabis flowerwitha meshscreenorsieve.



Abamectin Acephate Acequinocyl AcetamipridAldicarbAzoxystrobin BifenazateBifenthrinBoscalidCaptanCarbaryl CarbofuranChlorantraniliproleChlordaneChlorfenapyrChlorpyrifosClofentezine Coumaphos CyfluthrinCypermethrinDaminozide DDVP (Dichlorvos)

Diazinon Dimethoate Dimethomorph Ethoprop(hos)Etofenprox Etoxazole Fenhexamid Fenoxycarb Fenpyroximate Fipronil Flonicamid Fludioxonil Hexythiazox ImazalilImidaclopridKresoxim‐methyl Malathion MetalaxylMethiocarb Methomyl Methyl parathion Mevinphos

MyclobutanilNaled Oxamyl PaclobutrazolPentachloronitrobenzene Permethrin PhosmetPiperonylbutoxide Prallethrin Propiconazole PropoxurPyrethrins PyridabenSpinetoramSpinosadSpiromesifenSpirotetramat Spiroxamine Tebuconazole ThiaclopridThiamethoxam Trifloxystrobin

Non‐pesticide products may be used and include substances such as compost teas, biologically based foliar sprays, and lady bugs. Pesticides may be used during cannabisproduction and include cinnamon, clove, and garlic oils and capsaicin. The use of pesticidesnot currently registered and allowed for use on cannabis has been reported, including bleach, abamectin, floramite, bifenthrin, Physan, Regalia, and Grandevo. Some amount of residue from pesticides used during cultivation may be present in cannabis products, including cannabisflowersandconcentrates.

If the cannabis or cannabis product contains pesticides in concentrations higher than theBureau’s specified “action level” for any substance, the sample would fail quality assurance testing.

Microbiological ImpuritiesCertain bacterial and fungal microbiological impurities have been found on cannabis flowers,and contained in cannabis products. The Bureau will require testing laboratories to test for microbiological impurities, which are expected to include the following (the final list may includedifferentitems):



� Shigatoxin–producing Escherichia coli

� Salmonella spp. � Aspergillus fumigatus

� Aspergillus flavus

� Aspergillus niger

� Aspergillus terreus

If any of these microbiological impurities are detected in a sample, the sample would failqualityassurancetestingandtheproductmaynotbesoldto consumers.

Filth and Foreign MaterialsCannabis is subject to a range of pests that can be found in the final product. Some of the insects that have been found in cannabis include aphids, leafhoppers, mealybugs, thrips, green flies, black flies, slugs, spider mites, and whiteflies. Residue from mammals such as rodents, which are often attracted to cannabis, may be present as well. Hair from such rodents, as well as from pets (e.g., cats and dogs), can sometimes be found in cannabis flowers and plant material. Insects, hair, and other foreign material can be detected by examining the products under a microscope (McPartland 1996). Samples containing filth or foreign materials in amounts higher than levels set by the Bureau in regulation would fail quality assurancetestingandwouldnotbesoldtoconsumers.

MycotoxinsThe Bureau will require testing laboratories to test cannabis samples for mycotoxins, including aflatoxin and ochratoxin, both of which are from families of fungi that are sometimes found on agricultural crops (National Cancer Institute 2015; Schmale and Munkvold 2017). If mycotoxins are found at a concentration greater than the levels set by the Bureau by regulation, the sample would fail quality assurance testing and would not be sold toconsumers.

Moisture Content and Water ActivityMoisture content is a measurement of the concentration of water in a sample. The Bureau willsetlimitsforthemoisture contentofcannabis flowersthat maybesoldtoconsumers.

Water activity is a measurement of how available the water in a sample is to other things, like microorganisms. By measuring water activity, one can determine how much water isavailable to support microbial growth. Because of this, water activity is an important indicator of the possibility of microbiological contamination (Unger et al. 2014). The Bureau willsetwateractivitylevelsin itsregulationsimplementing MAUCRSA.

Heavy MetalsCannabis plants candraw in heavy metals from the soil in which they are grown (Handwerk2015). The Bureau will require laboratories to analyze samples for several heavy metals, which are expected to include arsenic, cadmium, lead, and mercury, although the final list



may include different metals. Samples testing higher than the Bureau’s action levels for any ofthese heavy metalswouldbe deemedto faillaboratorytesting.

3.5.3 Samples

The Bureau’s testing laboratory regulations will set out detailed sampling procedures andprotocols. The regulations will require licensed laboratories to develop and implement standard operating procedures that must be approved by the laboratory director and made available to all laboratory personnel.

Laboratory personnel are expected to wear appropriate personal equipment and use suitabletools when collecting samples. Some of personal equipment that may be used could includedisposable lab coats, coveralls, or aprons; filtering dust masks; safety goggles; hair nets, and disposable nitrile gloves. Some of the sanitized tools that could be used may include amber glass jars or containers with PTFE‐lined lids, cooler with ice packs, field balance, spoons,spatulas, tongs, and/or sampling devices. Laboratory personnel will be required to storesamples in tamper‐evident containers and handle the containers to ensure that there is no degradation of the sample while it is being transported to the laboratory. Laboratory personnel willberequiredto keeprecordspertainingto thesamplingevent and ensure that adequatechain‐of‐custodyprotocolsareobserved.

The Bureau will detail sampling procedures for unpackaged harvest batches and for packaged cannabis products. For each of these categories, the regulations will specify theprocess for collecting samples, the sample size, and the sample increments. For edible products, the regulations will contain requirements for homogeneity. The regulations willalsoaddressanyrequirementsforduplicatefieldsamples.

3.5.4 Methods for Analysis

The Bureau does not prescribe any specific method for analyzing samples for any particular contaminant or constituent. Rather, the regulations require that the laboratory must “develop and implement scientifically valid testing methodologies” that comport with guidelinesin:

� TheU.S.FoodandDrugAdministration’s Bacterial Analytical Manual (2016);

� AOAC International’s Official Methods of Analysis for Contaminant Testing of AOAC International,20th Edition(2016);

� Methods of analysis for contaminant testing published in the 2016 U.S. PharmacopeiaandtheNationalFormulary(USP‐NF);or

� If a laboratory wants to use an alternative scientifically valid testing methodology, thelaboratory shall validate the methodology and submit the standard operatingprocedureforthenew methodologyto the Bureau.



3.5.5 Typical Equipment Used

As a general matter, the Bureau does not specify in its regulations any particular testing equipment that must be used. Instead, the regulations require laboratories to develop theirown testing protocols based on recognized and certified testing methodologies. The followinglist provides a general description of some of the broad categories of typical equipment used.

Analytical Instruments High Performance Liquid Chromatography (HPLC) can be used to measure heat‐sensitive compounds such as THCA and CBDA because it does not require heating of the sample. The laboratory extracts a sample into a solvent and injects the extract into a liquid‐filledcolumnthat separatesthecomponents ofthe mixture based onphysical and chemical characteristics. Separated components are identified employing an ultraviolet(UV)orotherappropriatedetectorto measureconcentration.

Liquid Chromatography–Mass Spectrometry (LC‐MS/MS) can be used for chemicalresidue (pesticide) testing and like HPLC, separates extracted components of a mixture and then uses two mass spectrometers to identify and estimate the concentration of the components.

Gas Chromatography (GC‐FID) can be used for cannabinoid profiling for products thatwill be heated, smoked, or vaporized or that have already been fully decarboxylated priorto testing. Like HPLC, this method separates components of a mixture based on differencesinphysical and chemicalproperties.Unlikethe HPLC,the GC uses a gas‐filled column contained in an oven to perform separation and uses a Flame Ionization Detector (FID) to identify and estimate the concentration of the components. This method typicallydecarboxylatesanyacidiccannabinoids(THCA,CBDA,CBGA)presentin thesample.

Gas Chromatography–Mass Spectrometry (GC‐MS) can be used for chemical residue(pesticide) testing and terpene analysis. This method employs gas chromatography andtheuse of a massspectrometeras describedabove.

Gas Chromatography Headspace Analyzer with an FID (HS‐GC‐FID) can be used for the separation and quantification of residual solvents. This method is similar to GC‐FID, but instead of a sample being extracted with a solvent, the ambient air above a sample(i.e.,“headspace”)isintroducedintothegas‐filledcolumn.

Handheld and Lab Bench Measurement EquipmentThis equipment includes instruments to measure weight, pH, and temperature of samplesand extracts. It also includes automated mixing and stirring devices often used in extraction andsamplepreparation.

Glassware Glassware includes beakers, test tubes, cylinders, flasks, and other related glassware toprepare and storesamples.



Chemicals Various chemicals, such as compressed gases, acids, bases, buffers, and salts, are stored andused in the laboratory to prepare and analyze samples. Referencestandardsarealso usedtocalibrate and perform quality assurance and quality control of instrumentation. Safety DataSheets(SDS) for each chemicalarepresent onsite and availableto laboratorypersonnel.

Safety EquipmentExtractions with solvents are typically completed under a fume hood to allow proper ventilation of the laboratory and prevent inhalation. Laboratory personnel wear lab coatswith safety glasses. Hand protection is used as needed. Eye wash stations and fire extinguishersarepresent.

3.6 Cannabis Microbusiness Operations MAUCRSA’s microbusiness license type allows for vertical integration of commercialcannabis cultivation, manufacturing with nonvolatile solvents, distribution, and retail salesunder a single license to be issued by the Bureau. For the purposes of this analysis, it isassumed that, for each activity a licensed microbusiness plans to operate, the licensee willconduct operations as described under the relevant section in this chapter and that the regulations applicable to that license type will apply to those activities conducted by themicrobusiness. Because they have not been described elsewhere in this chapter, cultivation andmanufacturingaredescribedinmoredetailbelow.

3.6.1 General Operational Activities

A cannabis microbusiness under MAUCRSA will be a business that conducts several types ofcommercial cannabis activities under a single license. First, microbusinesses would be ableto cultivate cannabis plants, with a total canopy of less than 10,000 square feet. Cannabis cultivation activities are described below in “Cultivation Operations,” Section 3.6.2. Second, amicrobusiness would be permitted to conduct manufacturing activities using nonvolatilesolvents. Manufacturing activities are described in “Manufacturing,” Section 3.6.3, below.These manufacturing activities may include agitation, pressure, infusion, or CO2 extraction.Third, a microbusiness may conduct distribution activities, including arranging for producttesting or transporting cannabis or cannabis products. Distribution activities are describedabove in Section 3.3. Finally, the microbusiness may conduct retail sale activities, includingdelivery and on‐site consumption where allowed by the local jurisdiction. Retail sale activities are describedabove inSection3.4.

3.6.2 Cultivation Operations

Cannabis cultivation begins with the selection and planting of cannabis cuttings or seeds. Where possible, male seeds are separated from female seeds or, if not identified in the seed stage, male plants would be removed later in the cultivation process, prior to becoming mature. The cuttings or seeds are typically planted in pots with either a growing medium,soil, or an inert material used in hydroponic cultivation methods. Cuttings are preferred over


Documents

Commercial Cannabis Business Licensing Program · PDF filetesting and quality assurance of cannabis goods. ... analyzed for residual solvents. The regulations will provide a table