Cannabis Testing Laboratory Licensing

Cannabis Testing Laboratory Licensing

  • Collects samples of each cannabis goods batch from the  distributor’s premises
  • Tests cannabis goods in accordance with the Act and  regulations for:
    • Cannabinoids
    • Foreign material
    • Heavy metals
    • Microbial  impurities 
    • Mycotoxins
    • Moisture content and water activity
    • Residual pesticides
    • Residual solvents and processing  chemicals
    • Terpenoids
    • Homogeneity

Required Testing

Requirements
  • ISO/IEC 17025 accreditation
  • Collect samples from each batch at the  distributor’s premises
  • Harvest batch (prepacked or unpacked) equal to no  more than 50 pounds
  • Manufactured product batch equals no more than  150,000 units
  • Must develop and implement a chain of custody protocol to document the transportation, handling, storage, and  destruction of samples
  • Must generate a certificate of analysis for each primary sample the lab analyzes

What is covered by required testing by a Testing Laboratory?

§ 5716. Homogeneity Testing of Edible Cannabis Products (a) The laboratory shall analyze a sample of edible cannabis product that contains more than one serving per unit to determine whether the edible cannabis product is of homogeneous THC content. (b) The laboratory sha11 perform homogeneity testing when the first batch of edible cannabis product is tested before entering the retail market. Once the initial batch of the product passes homogeneity testing, and provided that the process for manufacturing and the composition of the edible cannabis product remains the same, a batch of edible cannabis product shall be tested for homogeneity every 6 months thereafter. (c) A sample of edible cannabis product shall be deemed to have passed homogeneity testing if the relative standard deviation of THC concentration between the samples collected does not exceed plus or minus 10%. (d) If a sample fails homogeneity testing, or the laboratory fails to perform homogeneity testing as required by this section, the batch from which the sample was collected fails homogeneity testing and may not be released for retail sale. (e) If a sample passes homogeneity testing, the laboratory shall perform all other analyses required under this chapter. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5717. Moisture Content and Water Activity Testing (a) The laboratory shall analyze a sample of cannabis to determine the level of water activity and the percentage of moisture content. (b) A cannabis sample shall be deemed to have passed water activity testing if the water activity does not exceed 0.65 Aw. The laboratory shall report the result of the water activity test on the certificate of analysis (COA) and indicate “pass” or “fail” on the COA. (c) A cannabis sample shall be deemed to have passed moisture content testing if the moisture content does not exceed 13.0%. The labaratory shall report the result of the moisture content test in percentage on the COA and indicate “pass” ar “fail” on the COA.

(d) The laboratory shall analyze edible cannabis products to determine the level of water activity. A solid or semi-solid edible cannabis product shall be deemed to have passed water activity testing if the water activity does not exceed 0.85 Aw. The laboratory shall report the result of the water activity test on the COA and indicate.”pass” or “fail” on the COA. (e) If a sample fails moisture content testing, the batch from which the sample was collected fails moisture content testing and sha11 not be released for retail sale. (fl If a sample fails water activity testing, the batch from which the sample was collected fails water activity testing and shall not be released for retail sale. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5718. Residual Solvents and Processing Chemicals Testing (a) The laboratory sha11 analyze a sample of cannabis product to determine whether residual solvents or processing chemicals are present. (b) The laboratory shall report the result of the residual solvents and processing chemicals testing in unit micrograms per gram (µg/g) on the COA and indicate “pass” or “faiP’ on the COA. (c) A sample shall be deemed to have passed the residual solvents and processing chemicals testing if both of the following conditions are met: (1) The presence of any residual solvent or processing chemical listed in the following tables in Category I is not detected, and (2) The presence of any residual solvent or processing chemical listed in the following tables in Category II does not exceed the indicated action levels. Category I Residual Solvent or CAS No. Processing Chemical 1,2-Dichloroethane 107-06-2 Benzene 71-43-2 Chloroform 67-66-3 Ethylene oxide 75-21-8 Methylene chloride 62-73-7 Trichloroethylene 79-01-6

Residual Solvent or CAS No. Inhalable Cannabis and Other Cannabis and Processing Chemical Cannabis Products Cannabis Products Acetone 67-64-1 3100 5000 Acetonitrile 75-OS-8 6 410 Butane 106-97-8 5000 5000 Ethanol 64-17-5 5000 5000 Ethyl acetate 141-78-6 5000 5000 Ethyl ether 60-29-7 5000 5000 Heptane 142-82-5 5000 5000 Hexane 110-54-3 70 290 Isopropyl alcohol 67-63-0 320 5000 Methanol 67-56-1 400 3000 Pentane 109-66-0 5000 5000 Propane 74-98-6 5000 5000 ..Toluene 108-88-3 30 890. Total xylenes (ortho-, 1330-20-7 10 2170 meta-, para-) (d) If a sample fails residual solvents and processing chemicals tesring, the batch from which the sample was collected fails residual solvents and processing chemicals testing and shall not be released for retail sale. Authority: Section 26013, Business, and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5719. Residual Pesticides Testing (a) The laboratory shall analyze a sample of cannabis or cannabis product to determine whether residual pesticides are present. (b) The laboratory shall report the result of the residual pesticides tesring in unit micrograms per gram (µg/g) on the COA and indicate “pass” ar “fail” on the COA.

(c) A sample shall be deemed to have passed the residual pesticides tesring if both of Che following conditions aze met: (1) The presence of any residua] pesticide listed in the following tables in Category I are not detected, and (2) The presence of any residual pesticide listed in the following tables in Category II does not exceed the indicated action levels. Category I CAS No. Residual Pesticide Aldicarb 116-06-3 Carbofuran 1563-66-2 Chlordane 57-74-9 Chlorfenapyr 122453-73-0 Chlorpyrifos 2921-88-2 Coumaphos 56-72-4 Daminozide 1596-84-5 DDVP (Dichlorvos) 62-73-7 Dimethoate 60-51-5 Ethoprop(hos) 131947-48-4 Etofenprox 80844-07-1 Fenoxycazb 72490-01-8 Fipronil 120068-37-3 Imazalil 35554-44-0 Methiocazb 2032-65-7 Methyl parathion 298-00-0 Mevinphos 7786-34-7 Paclobutrazol 76738-62-0 Propoxur 114-26-1 Spiroxamine 118134-30-8 Thiacloprid 111988-49-9

(d) If a sample fails residual pesricides testing, the batch from which the sample was collected fails pesticides testing and shall not be released for retail sale

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5720. Microbial Impurities Testing (a) The laboratory shall analyze a sample of cannabis or cannabis product to determine whether microbial impurities are present. (b) The laboratory shall report the result of the microbial impurities testing by indicating “pass” or “fail” on the COA. (c) A sample of inhalable cannabis or inhalable cannabis product shall be deemed to have passed the microbial impurities testing if all of the following conditions aze met: (1) Shiga toxin producing Escherichia toll is not detecCed in 1 grain; (2) Salmonella spp. is not detected in 1 gram; and (3) Pathogenic AspergilZus species A. fumigatus, A. flavus, A. niger, and A. terreT{s are not detected in 1 gram. (d) A sample of other cannabis or cannabis product sha11 be deemed to have passed the microbial _ impurities testing if both the following: (1) Shiga toxin producing Eseherichia eoli is not detected in 1 gram, and (2) Salmonella spp. is not detected in 1 gram. (e) If a sample fails microbial impurities testing, the batch from which the sample was collected fails microbial impurities testing and shalt not be released for retail sale: Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 572E Mycotoxin Testing (a) The laboratory shall analyze a sample of cannabis ar cannabis product to determine whether mycotoxins are present. (b) The laboratory shall report the result of the mycotoxins testing in unit micrograms per kilograms (µg/kg) on the COA and indicate “pass” ar “fail” on the COA. (c) A sample shall be deemed to have passed mycotoxin testing if both the following conditions are met: (1) Total of aflatoxin B1, B2, G1, and G2 does not exceed 20 µg/kg of substance, and (2) Ochratoxin A does not exceed 20 µg/kg of substance. (d) If a sample fails mycotoxin testing, the batch from which the sample was collected fails mycotoxin testing and shall not be released for retail sate.

Authority: Secrion 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5722. Foreign Material Testing (a) The laboratory shall analyze a sample of cannabis or cannabis product to determine whether foreign material is present. (b) The labaratary sha11 report the result of the foreign material test by indicaring “pass” or “fail” on the COA. (c) The laboratory shall perform foreign material testing on the total primary sample prior to sample homogenization. (d) When the laboratory performs foreign material testing, at minimum, the laboratory shall do all of the following: (1) Examine both the exterior and interior of the cannabis sample, and (2) Examine the exterior of the cannabis product sample. (e) A sample shall be deemed to have passed the foreign material testing if the presence of foreign material does not exceed: (l) 1/4 of the total sample area covered by sand, soil, cinders, or dirt; (2) 1(4 of the total sample area covered by mold; (3) 1 insect fragment, 1 rodent hair, or 1 count mammalian excreta per 3.0 grams; ar (4) 1 /4 of the total sample area covered by an imbedded foreign material. (~ If a sample fails foreign material testing, the batch from which the sample was collected fails foreign material testing and shall not be released for retail sale. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5723. Heavy Metals Testing (a) The laboratory shall analyze a sample of cannabis or cannabis product to determine whether heavy metals aze present. (b) The laboratory shall report the result of the heavy metals test in micrograms per gram (µg/g) on the COA and indicate “pass” or “fail” on the COA. (c) A sample shall be deemed to have passed the heavy metals testing if the presence of heavy metals does not exceed the action levels listed in the following table. (d) If a sample fails heavy metals tesCing, the batch from which the sample was collected fails heavy metals testing and shall not be released for retail sale.

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5724. Cannabinoid Testing (a) The laboratory shall analyze a sample of cannabis or cannabis product to determine whether the cannabinoid profile of the sample conforms to the labeled content. of each cannabinoid such as THC; THCA; CBD; CBDA; CBG; and CBN. (b) The laboratory shall report the result of the cannabinoid testing on the COA both as a percentage and in milligrams per gram (mg/g) dry-weight using the following equation and indicate “pass” or “fail” on the COA: Dry-weight percent cannabinoid =wet-weight percent cannabinoid / (1 —percent moisture / 100) (c) If the labeled content of any one cannabinoid is expressed as a total concentration of the cannabinoid, the laboratory shall calculate the total cannabinoid concentration as follows: Total cannabinoid concentration (mg/g) _ (cannabinoid acid form concentration (mg/g) x 0.877) + cannabinoid concentration (mg/g) (d) A sample shall be deemed to have passed the cannabinoid testing if the concentration of any one cannabinoid does not exceed the labeled content of the cannabinoid, plus or minus 10%. (e) If the sample fails cannabinoid Testing, the batch from which the sample was collected fails cannabinoid testing and shall not be released for retail sale. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5725. Terpenoid Testing (a) The laboratory_shall analyze a sample of cannabis or cannabis product to determine whether the terpenoid profile of the sample conforms to the labeled content of terpenoids.

(b) The laboratory shall report the result of the terpenoid tesring on the COA both as a percentage and in milligrams per gram (mg/g) and indicate “pass” or “fail” on the COA. (c) A sample shall be deemed to have passed the terpenoid testing if the concentration of terpenoids does not exceed the labeled content of total terpenoids, plus or minus 10 percent. (d) If a sample fails terpenoid testing, the batch from which the sample was collected fails terpenoid testing and shall not be released for retail sale.

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.

Testing Laboratory

What are the operating requirements for a Testing Laboratory?

§ 5701. General Laboratory License Requirements (a) A licensed laboratory shall maintain ISO/IEC 17025 accreditation for the testing of the following: (1) Cannabinoids; (2) Heavy metals; (3) Microbial impurities; (4) Mycotoxins; (5) Residual pesticides; (6) Residual solvents and processing chemicals; and (7) If tested, terpenoids. (b) A licensed laboratory shall retain, and make available to the Bureau upon request, all records associated with the licensee’s ISO/IEC 17025 certificate of accreditation. Authority: Section 26013, Business and Professions Code. Reference: Section 26100, Business and Professions Code

§ 5702. Laboratory License Application In addition to the information required in section 5002 of this division, an application for a testing laboratory license includes the following: (a) A valid certificate of accreditation, issued by an accreditation body, that attests to the laboratory’s competence Yo perform testing of the following: (1) Cannabinoids; (2) Heavy metals; (3) Microbial impurities; (4) Mycotoxins; (5) Residual pesticides; (6) Residual. solvents and processing chemicals; and (7) I£tested,terpenoids. (b) Standard operating procedures for the following testing methods: (1) Cannabinoids; (2) Foreign material; (3) Heavy metals; (4) Microbial impurities; (5) Moisture content and water activity; (6) Mycotoxins; (7) Residual pesticides; (8) Residual solvents and processing chemicals; (9) If tested, terpenoids; and (10) If tested, homogeneity. (c) Standard operating procedures for the sampling of cannabis and cannabis products. Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26050, 26051.5, 26055, 26102 and 26104, Business and Professions Code.

§ 5703. Provisional Testing Laboratory License (a) A laboratary may apply for a provisional license prior to receiving ISO/IEC 17025 accreditation provided that the applicant meets all other licensure requirements for a testing laboratory and submits to the Bureau an application in compliance with section 5002 of this division and an attestation that the applicant has or intends to seek ISO/IEC 17025 accreditation for all testing methods required. by this division. (b) A provisional testing laboratory license shall be valid for 12 months. The annual license fee for a provisional license shall be determined pursuant to section 5014 of this division. (c) To timely renew a provisional license, a completed license renewal form and the annual renewal license fee pursuant to section 5014 of this division shall be received by the Bureau from the licensee no earlier than 60 calendar days before the expiration of the license and no later than 5:00 p.m. Pacific Time on the last business day before the expiration of the license if the renewal form is submitted to the Bureau at its office(s), or no later than 11:59 p.m. on the last business day before the expiration of the license if the renewal form is submitted to the Bureau through its electronic licensing system. Failure to receive a notice for license renewal does not relieve a licensee of the obligation to renew a provisionallicense as required. (d) In the event the license is not renewed prior to the expgation date, the licensee must not test any cotmnercial cannabis goods until the license is renewed. (e) A licensee may submit a license renewal form up to 30 days after the license expires. Any, late renewal’ form will be subject to a Iate fee. equal to 50 percent of the applicable licensing Fees :required by subsection (c) of this section, (fl The license renewal form shall contain the following; (1) The name of the licensee. For licensees who are individuals, the applicant shall provide both the first and last name of the individual. For licensees who are business entities, the licensee shall provide the legal business name of the applicant; (2) The license number and expiration date; (3) The licensee’s address of record and premises address; and (4) An attestation that all information provided to the Bureau in the original application under section 5002 of this division or subsequent notification under secrion 5023 of this division is accurate and current. (g) The Bureau may renew a provisional license for an initial renewal period of 12 months. (h) After one renewal, the Bureau may renew the provisional license for additional 12-month periods if the licensee has submitted an application for the ISO/IEC 17025 accreditation. In addition to the information required for a renewal form pursuant to subsection (fl o£ this section, any renewal request pursuant to this section sha11 also include an attestation that the licensee’s application for eachISO/IEC 17025 is pending with the accrediting body, themine of the accrediting body, and the date the application was submitted to the accrediting body.

(i) The licensee shall notify the Bureau if the applicarion for each ISO/IEC 17025 accreditation is granted or denied within 5 business days of receiving the decision from the accrediting body. If the accrediting body grants or denies the licensee’s application for any ISO/IEC 17025 accreditation before the expiration of the provisional license, the Bureau may terminate the provisional license at that time. (i) The Bureau may revoke a provisional license at any time., Authority: Section 26013, Business and Professions Code. Reference: Sections 26012 and 26050, Business and Professions Code. Article 3. Sampling Cannabis and Cannabis Products § 5704. Sampling Standard Operating Procedures (a) The laboratory sha11 develop and implement a sampling standard operating procedure (SOP) that describes the laboratory’s method for obtaining representative samples of cannabis and cannabis product. (b) The sampling SOP shall include the following information: (1) A procedure for obtaining samples of each matrix type the laboratory samples, and (2) A procedure for the collection of samples to perform homogeneity analysis of edible cannabis products. (c) The sampling SOP shall specify that during sampling, the sampler shall, aY minimum: (1) Follow the laboratory’s sampling SOP; (2) Ensure that the sampling area is free of contaminants;. (3) Sanitize sampling tools between each batch; (4) Use disposable. gloves and change gloves between each batch; (5) Weigh samples to within 0.1 gram of accuracy using a calibrated balance; (6) Collect both a primary and a field duplicate sample from each batch; (7) Place the sample in a container capable of preventing degradation or contamination and seal the sample container with tamper-evident material; (8) Assign a unique sample identifier to both the primary and field duplicate samples; (9) e Record on the sample field log the conditions under which the sample is transported and stored; (10) Follow chain of custody protocols; and (11) Complete the sample field log.

(d) The supervisory or management laboratory employee shall review, approve, sign, and date the sampling SOP and each revision thereto. (e) The laboratory shall retain a copy of the sampling SOP on the laboratory premises and ensure that the sampling SOP is accessible to the sampler during sampling. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26102, 26104 and 26110, Business and Professions Code. § 5705. General Sampling Requirements (a) The laboratory that obtains samples from a distributor shall perform the required testing. (b) The laboratory may obtain and analyze samples only from batches in final form as required by Business and Professions Code section 26100. (c) The laboratory shall collect both a primary sample and a field duplicate sample from each batch. The primary sample and field duplicate sample shall be stored and analyzed separately. (d) The laboratory shall ensure that the sample is transported and subsequently stored at the laboratory in a manner that prevents degradation, contamination, and tampering. If the caimabis or cannabis product specifies on the label how the product shall be stored, the laboratory sha11 store. the sample as indicated on the label (e) The laboratory shall complete a chain of custody form and sample field log for each sample that the laboratory collects and analyzes. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 ………and 26110,Business and Professions Code. § 5706. Sample Field Log The sampler shall use a sample field log to record the following informarion for each sampled batch: (a) Laboratory’s name, address, and license number; (b) Sampler’s names) and titie(s); (c) Date and time sampling started and ended; (d) Distributor’s name, address;and license number; (e) Cultivator’s, manufacturer’s, or microbusiness’ name, address, and license number; (fl Batch number of the batch from which the sample was obtained; (g) Sample matrix; (h) Total batch size, by weight or unit count; (i) Total weight or unit count of the primarq sample;(j) Total weight or unit count of the field duplicate sample; (k) The unique sample identification number for each sample; and (1) Sampling conditions or problems encountered during the sampling process, if any. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 2611Q Business and Professions Code. § 5707. Harvest Batch Sampling (a) The sampler shall obtain both a primary sample and a field duplicate sample from each prepacked or unpacked harvest batch. The primary sample and field duplicate sample must each weigh 0.35% of the total harvest batch weight. The sampler shall collect the field duplicate sample contemporaneous to, and in the same manner. as, collection of the primary saanple. (b) A sampler may collect greater than 0.35% of a prepacked or unpacked harvest batch per primary sample and field duplicate sample if necessary to perform the required testing or to ensure that the samples obtained are representative. (c) The prepacked or unpacked harvest batch from which a sample is obtained shall weigh no more than 50.0 pounds. Laboratory analyses of a sample collected frmn a harvest batch weighing more than 50.0 pounds shall be deemed invalid and the harvest batch from which the sample was obtained may not be released for retail sale. (d) When the sampler obtains a primary sample and a field duplicate sample from an unpacked harvest batch, the sampler shall do all the following: (1) Collect the number of increments per primary sample and field duplicate sample relative to the unpacked harvest batch size as listed in the following table; (2) Obtain increments from random and varying locations of the unpacked harvest batch, both vErtically and horizontally. To the extent practicable, the increments obtained from an unpacked harvest batch shall be of equal weight; and (3) To the extent practicable, collect an equal number of increments from each container if the unpacked harvest batch is stored in multiple containers. Unpacked Harvest Batch Size Number of Increments (pounds) (per sample) < 10.0 8 10.1-20A 16 20.1 — 30.0 23 30.1 — 40.0 29 40.1 — 50.0 34

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5708. Cannabis Product Batch Sampling (a) The sampler shall collect both a primary sample and a field duplicate sample from each cannabis product batch. The sampler shall collect the field duplicate sample contemporaneous Co, and in the same manner as, collection of the primary sample. (b) The sampler may collect a greater number of increments per primary sample and field duplicate sample if necessary to perform the required testing or to ensure that the samples obtained are representative. (c) The cannabis product batch from which a primary sample and a field duplicate sample are obtained sha11 contain no more Phan 150,000 units. Laboratory analyses of a sample collected from a cannabis product batch containing more than 150,000 units shall be deemed invalid and the cannabis product batch from which the primary sample and a field duplicate sample were obtained may. not be released for retail sale. (d) The sampler shall obtain a primary sample and a field duplicate sample of cannabis product by collecting, at minimum, the mm~ber of increments per sample relative to the cannabis product batch size as listed in the following table. Each increment consists of 1 packaged unit. Cannabis Product Batch Size Number of Increments (uniCs) (per sample) < Sp 2 51 —150 3 151 — 500 5 501 — 1,200 8 1,201 — 3,200 13 3,201 — 10,000 20 10,001 — 35,000 32 35,001 —150,000 50

Proposed Regs. – Oct 19, 2018

§ 5701. General Laboratory License Requirements

This section has been amended by adding Section 26012 of the Business and Professions Code to the reference section. This change is necessary for accuracy.

§ 5702. Laboratory License Application

This section has been amended to require that the standard operating procedures for testing foreign material be included with an application for licensure. The section has been amended to remove foreign material and moisture content from the required method validation reports for certain testing methods. These amendments were necessary for consistency with regulations regarding testing for these items. The section has been renumbered to account for these amendments.

This section has also been amended to remove section 26051.5 of the Business and Professions Code from the reference section. This is necessary for accuracy.

§ 5703. Interim Testing Laboratory License

The title of this section has been amended from “Provisional Testing Laboratory License.” The term “provisional” has also been replaced with the term “interim” throughout the section. These changes were necessary due to a recent change in legislation that created a provisional license category for all commercial cannabis licensees. Subsection (a) has been revised by replacing “A laboratory” with “An applicant” to specify and clarify that the provision applies to an applicant. This change is necessary for consistency in the use of terms throughout the regulations.

Subsection (b) has been revised to clarify and specify that the annual license fee is determined pursuant to the requirements in section 5014 for annual license fees for a testing laboratory license. This change was necessary to provide applicants clarity on how their licensing fee is determined.

Subsection (i) has been amended to require licensed testing laboratories to notify the Bureau if the licensees application for ISO/IEC 17025 accreditation have been approved or denied within 1 day of receiving the decision. This is being changed from requiring the licensee to provide notice to the Bureau within 5 days of receiving the decision. This is necessary because the Bureau has determined that it is critically important that the Bureau be informed of a denial and for consistency with the statute. Additionally, the Bureau has determined that the additional burden to the licensee caused by this change is relatively small. Subsection (i) has also been amended to incorporate by reference a form for licensees to submit to the Bureau the required notification in this section. This is necessary to provide clear direction to licensees on how to submit the required notification.

The reference section has been revised to include section 26102 of the Business and Professions Code.

Changes Made to Article 3. Sampling Cannabis and Cannabis Products

The Sampling -Standard Operating Procedures Form, BCC-LIC-021 (New 10/18) was amended to correct for typographical and grammatical errors. Specifically, section 4 for the signature of the supervisory or management laboratory employee was amended to section 3, to correct the numbering of the section.

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code..

 

What are the phase-in reqs for Test Labs?

§ 5715. Phase-In of Required Laboratory Testing (a) Cannabis and cannabis products shall not be sold or transferred to a retailer, or released for retail sale,. unless a representative sample of the cannabis or cannabis product has undergone and passed all testing as required by this section. (b) All cannabis harvested on or after January 1, 2018, and all cannabis products manufactured on or after January 1, 2018, sha11 be tested for the following analytes, if applicable: (1) Cannabinoids as required in section 5724 of this division; (2) Moisture content as required in section 5717 of this division; (3) Category II Residual Solvents and Processing Chemicals as required in section 5718 of this division; (4) Category I Residual Pesticides as required in section 5719 of this division; (5) Microbial Impurities as required in section 5720 of this division; and (6) Homogeneity as required in section 5716 of this division. (c) In addition to the requirements of subsection (b) of this section, all cannabis harvested on or after July i, 2018, and all cannabis products manufactured on or after July 1, 2018, shall be tested for the following analytes, if applicable: (1) Category I Residual Solvents and Processing Chemicals as required in section 5718 of this division; (2) Category II Residual Pesticides as required in section 5719 of this division; and (3) Foreign Material as required in section 5722 of this division. (d) In addition to the requirements in subsections (b) and (c) of this section, all cannabis harvested on or after December 31, 2018, and ail cannabis products manufactured on or after December 31, 2018, shall be tested for the following analytes, if applicable: (1) Terpenoids as required in section 5725 of this division; (2) Mycotoxins as required in section 5721 of this division; (3) Heavy Metals as required in section 5723 of this division; and (4) Water Activity as required in section 5717 of this division. (e) Licensees may have a sample of cannabis or cannabis products tested for analytes that are not yet required to be tested. However, if the sample fails any additional tests) not required pursuant to this section on the date of testing, the batch from which the sample was collected fails testing and shall not be released for retail sale.

Proposed Regs. – Oct. 19, 2018

§ 5715. Phase-In of Required Laboratory Testing

This section has been amended by adding Section 26110 of the Business and Professions Code to the reference section. This change is necessary for accuracy.

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100 and 26104, Business and Professions Code.

What are the definitions applicable to Testing Laboratories?

§ 5700. Defwitions In addirion to the definitions in section 5000 of this division, the following definitions apply to this chapter. (a) “Acceptance criteria” means the specified limits placed on the. characteristics of an item or method that are used to determine data quality. (b) “Accredited college or university” means a college ar university accredited by a regional or national accrediting agency that is an accreditar recognized by the Secretary of the US Department of Education. (c) “Accreditation body” means an impartial non-profit arganization that operates in conformance with the International Organization for Standardization (ISO) /International Electrotechnical Commission (IEC) standard 17011 and is a signatory to the International Labaratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) for Testing. (d) “Action level” means the threshold value that provides the. criterion fpr determining whether a sample passes or fails an analytical test. (e) “Analyte” means a chemical, compound, element, bacteria, yeast, fungus, or toxin to be identified or measured. (fl “Analytical batch” means a group of samples that is prepared together for the same analysis. . and analyzed sequentially using the same instrument calibration curve and that have common analytical quality control checks. (g) “Analytical method” means a technique used qualitatively or quantitatively to determine the composition of a sample or a microbial contamination of a sample. (h) “Cannabinoid” means a class of diverse chemical compounds derived from a cannabis plant. (i) “CAS number” means the unique numerical identifier assigned to every chemical substance by Chemical Abstracts Service, a division of the American Chemical Society. (j) “CBD” means cannabidiol, CAS number 13956-29-L (k) “CBDA” means cannabidiolic acid, CAS number 1244-58-2. (1) “CBG” means cannabigerol, CAS number 25654-31-3. (m) “CBN” means cannabinol, CAS number521-35-7. (n) “Certificate of accreditation” means a document issued by an accreditation body that attests to the laboratory’s competence to carry out specific testing analysis.

(o) “Certificate of analysis” means the report prepared by the laboratory about the analytical testing performed and results obtained by the laboratory. (p) “Certified reference materiaP’ means a reference material prepared by a certifying body or a party independent of the laboratory with ISO/IEC 17034 accreditation. (c~ “Continuing calibration verification” means a type of quality control sample that is a midrange calibration standard which checks the continued validity of the initial calibration of the inshument. (r) `Exclusivity” means the specificity of the test method for validating microbial testing methods. Tt evaluates the ability of the method to disringuish the target organisms from similar buY genetically distinct non-target organisms. (s) “Field duplicate sample” means a sample that is taken in the identical manner and from the same cannabis batch being sampled as the primary sample. It is analyzed separately from the primary sample and is used for quality control purposes only. (t) “Foreign material” means any filthy, putrid, or decomposed substance including hair, insects, excreta, or related adulterant that. may be hazardous or cause illness or injury to the consumer. (u) “Frequency” means the number of items occurring in each category. Frequency maybe determined by analytical method ar laboratory specific requirements for accuracy, precision of the analysis, or statistical calculation. (v) “Sample increment” means a portion of a batch that, together with other increments, makes up the sample. (w) “Inclusivity” means, related to microbiological method validation, the sensitivity of the test method. It evaluates the ability of the test method to detect a wide range of target organisms by a defined relatedness, (x) “Inhalable” means consumable in gaseous or vapor form through the lungs. (y) “ISO/IEC” means the joint technical committee of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). (z) “ISO/IEC 17025” means the general requirements specified by the ISO/IEC for the competence of testing and calibration laboratories. (aa) “ISO/IEC 17034” means the general requirements established by the ISO/TEC for the competence of reference material producers. (bb) “ISO/IEC 17043” means the general requirements established by the ISO/IEC for proficiency testing. (cc) “Laboratory” means “testing laboratory” as defined at Business and Professions Code .section 26001(as).

(dd) “Laboratory replicate sample” means a duplicate sample of the primary sample used for quality control purposes to demonstrate reproducibility. It is prepared in the identical manner as the primary sample and analyzed separately from the primary sample. (ee) “Laboratory quality assurance” means the set of operating principles that enable laboratories to produce defensible data of known accuracy and precision and includes employee training, equipment preventative maintenance procedures, calibration procedures, and quality control testing, among other things. (f~ “Limit of detection” means the lowest quantity of a substance or analyte that can be distinguished from the absence of that substance within a stated confidence limit. (gg) “Lunit of guantitarion” means the minimum concentration of an analyte in a specific matrix that can be reliably quantified while also meeting predefined goals for bias and imprecision. (hh) “Matrix”.means the substances fhat are present in a sample except for the analyte(s) of interest. (ii) “Matrix spike duplicate” means the duplicate sample of the matrix spike sample that is prepared by adding a known quantity of a target analyte to a sample matrix or to a matrix that is as closely representative of the matrix being analyzed as possible. (jj) “Matrix spike sample” means a sample prepazed by adding a lrnown quantity of the target analyte to a sample matrix or to a matrix that is as closely representative. ofthe matrix being analyzed as possible. (kk) “Method blank” means an analyte free matrix fo which all reagents are added in the same volumes orproportions as used in the sample preparation. (11) “Moisture content’ means the percentage of water in a sample; by weight. (mm) “Non-target organism” means an organism that the test method or analytical procedure is not testing for and can be used in evaluating the specificity of a test method. (nn) “Percent recovery” means the percentage of a measured concentration relative to the added (spiked) concentration in a reference material, matrix spike sample, or matrix spike duplicaCe. A laboratory shall calculate the percent recovery by dividing the sample result by the expected result then multiplying that the quotient by 100. (oo) “Practical experience” means experience performing scientific analytical tests in a labaratory setting using equipment, instruments, kits, and materials routinely found in a laboratory. Practical experience includes experience in any type of laboratory setting and is not lunited to cannabis-specific laboratories. (pp) “Primary sample” means a sample that is comprised of several increments of either cannabis or cannabis products that are collected from a batch for testing. (qq) “Proficiency tesP’ means an evaluation of a laboratory’s performance against preestablished criteria by means of interlaboratory comparisons of test measurements.

(rr) “Proficiency test sample” means a sample that is prepared by a party independent of the testing laboratory with the ISO/IEC 17043 accreditation, where the concentration and identity of an analyte that is known to the independent party, but is unknown to the testing labaratory and testing laboratory employees. (ss) “Quality control” means the set of measures implemented within an analytical procedure to ensure that the measurement system is operating in a state of statistical control for which errors have been reduced to acceptable levels. (tt) “Quality control sample” means a sample that is produced and used by a laboratory for the purpose of assuring the quality of the data and results. Quality control samples include blank samples, matrix spike samples, field duplicate samples, replicate samples, and reference material samples. (uu) “Reagent” means a compound or mixture added to a system to cause a chemical reaction ar test if a reaction occurs. A reagent may be used to tell whether a specific chemical substance is present by causing a reaction to occur with the chemical substance. (vv) “Reference material” means material containing a known concentration of an analyte of interest that is in solution or in a homogeneous matrix. (ww) “Reference method” means the method by which the performance of an alternate method is measured or evaluated. (xx) “Relative percent difference” means the comparative statistic that is used to calculate precision or random errar. RPD is calculated using the following equation: RPD = ~ (primary sample measurement —duplicate sample~measurement) I / ([primary sample measurement +duplicate sample measurement] / 2) X 100% (yy) “Relative standard deviation” means the standard deviation expressed as a percentage of the means recovery. RSD is calculated using the following equation: RSD = (s / x) X 100%; where s =standard deviation and x =mean (zz) “Representative” means a small quantity of the batch whose characteristics represent, as accurately as possible, the entire batch, thus allowing the results to be generalized. (aaa) “Requester” means the person who submits a request to the laboratory for testing of catmabis or cannabis product from an entity licensed under this division. (bbb) “Sample” means a representative part of, or a single item from, a batch which is comprised of several sample increments. (ccc) “Sampler” means the laboratory employee responsible for obtaining samples of cazmabis or cannabis product from a distributor. (ddd) “Sanitize” means to sterilize, disinfect, or make hygienic.

(eee) “Scope of accreditation” means the tests or types of tests per#~ormed, materials or producTs tested, and the methods used for testing cannabis or cannabis products for which the accreditarion has been granted. (fffl “Tamper-evident’ means aone-time-use security tape or seal that is affixed to the opening of a package, allowing a person to recognize whether the package has been opened. (ggg) “Target organism” means an organism that is being tested for in an analytical procedure or test method. (hhh) “THC” and “delta-9 THC” means tetrahydrocannabinol, CAS number 1972-08-3. (iii) “THCA” means tetrahydrocannabinolic acid, CAS number 23978-85-0. (jjj) “Validation” means the confirmation by examination and objective evidence that the requirements for a specific intended use or analytical method aze fulfilled. (kkk) “Water activity” means the measure of the quantify of water in a product that is available and therefore capable of supporting bacteria, yeasts, and fungi and which is reported in units Aw.

Proposed Regs. October 19, 2018

§ 5700. Definitions

The numbering of the section has been modified to allow for the inclusion of additional definitions. The definitions for the terms “accreditation body” and “accredited college or university” have been reordered in order to properly place the terms in alphabetical order.

A definition of “cannabis concentrate” has been added to the section and defines a cannabis concentrate as cannabis that has undergone a process to concentrate one or more active cannabinoids, thereby increasing the product’s potency. The definition clarifies that cannabis concentrates includes the following items: the separated resinous trichomes of cannabis, tinctures, capsules, suppositories, extracts, vape cartridges, inhaled products (such as dab, shatter, and wax), and tablets as defined by the State Department of Public Health in regulation. This is necessary to clarify what a cannabis concentrate is, and to align with the term as it is used by other licensing authorities and in regulations.

The definition of “continuing calibration verification” has been revised to further clarify that a licensed testing laboratory must be able to test for each required analyte.

A definition of “good laboratory practice” has been added to the section and defines good laboratory practice as being a quality system of management controls for laboratories to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of analyses performed by the testing laboratory. This definition is necessary because the term is used in the regulations to ensure that laboratories are operating in accordance with general laboratory standards.

The definition of “initial calibration verification” has been amended to remove “targeted” and replace it with “each of the targeted” for clarity. This is necessary to ensure that licensees understand that each analyte must be included.

The definition of “laboratory control sample” has been amended to clarify that spiked concentration must be at a mid-range concentration of the calibration curve for the target analytes. This change is necessary to ensure accuracy in testing procedures.

A definition of “linear regression” has been added to the section and defines linear regression as the determination, in analytical chemistry, of the best linear equation for calibration data to generate a calibration curve. The concentrate of an analyte in a sample can then be determined by comparing a measurement of the unknown to the calibration curve. A linear regression uses the following equation: y = mx + b, where m =slope and b=intercept. This definition is necessary because the term is used in the regulations and ensures laboratories analyze cannabis goods samples using accurate calibration data.

The definition of “matrix spike sample” has been revised to provide additional clarity. This is necessary to ensure standardization in the licensees’ quality control procedures.

A definition for “orally-consumed product containing alcohol” has been added. This addition is necessary to clarify that an “orally-consumed product containing alcohol” means a liquid solution that contains more than 0.5% alcohol by volume as an ingredient, is not otherwise an alcoholic beverage as defined in Business and Professions Code section 23004, is packaged in a container no larger than two (2) fluid ounces and includes a capped calibrated dropper capable of accurately measuring servings. This definition is necessary to align with regulations promulgated by the State Department of Public Health which allows for certain products to contain alcohol as an ingredient. Without this definition testing laboratories would not be able to determine which cannabis products are exempt from the ethanol limit for residual solvent testing under proposed section 5718.

A definition for “orally-dissolving product” has been added. This is necessary to clarify that the term “orally-dissolving product” as used in the regulations means an edible cannabis product that is intended to dissolve and release cannabinoids directly into the mouth, which allows them to enter the bloodstream through the tissue, such as sublingual lozenges or mouth strips. The definition further clarifies that orally dissolving products are not intended to be eaten or swallowed to enter the digestive system. This definition is also necessary to ensure consistency between regulations adopted by the Bureau and the State Department of Public Health.

A definition for pre-roll has been added to specify that for purposes of this chapter, pre-roll has the same meaning as in section 5000(q) and also includes pre-rolls infused with cannabis concentrate. This is necessary to ensure testing laboratories have accurate guidance to identify the type of cannabis goods being tested.

A definition for “quadratic regression” has been added to the section and defines quadratic regression as means the determination, in analytical chemistry, of the best parabola equation for calibration data to generate a calibration curve. The concentrate of an analyte in a sample can then be determined by comparing a measurement of the unknown to the calibration curve. A quadratic regression uses the following equation: y = ax2 + bx + c, where a, b, and c are numerical coefficients. This definition is necessary because the term is used in the regulations and ensures laboratories analyze cannabis goods samples using accurate calibration data.

The definition of “relative percent difference” has been amended to provide an abbreviation for the term defined, RPD, to allow for subsequent use of the abbreviated term in the regulations.

The definition of “relative standard deviation” to provide an abbreviation for the term defined, RSD, to allow for subsequent use of the abbreviated term in the regulations.

The definition of “representative sample” to clarify and specify what a “representative sample” comprises of, which is several sample increments of cannabis goods that are collected from a batch for testing.

The definition of “requester” has been amended to clarify and specify the requirement referenced in this subsection is a requirement under MAUCRSA, not under the proposed regulations.

The definition of “sampler” has been amended to clarify that a licensed microbusiness authorized to engage in distribution, not just any microbusiness, is included. This is necessary for clarity and consistency throughout the regulations.

A definition for “topical cannabis goods” has been added. This is necessary to clarify that the term “topical cannabis goods” means cannabis products intended to be applied to the skin and not intended to be ingested or inhaled. Liquid solutions shall only be considered topical cannabis goods if they are packaged in a container no larger than two (2) fluid ounces.

A definition for “total CBD” has been added and defines total CBD as the molar sum of CBD and CBDA. Total CBD is calculated using the following equation in which “M” is the mass or mass fraction of CBD and CBDA: M total CBD = M CBD + (0.877 x M CBDA). This definition is necessary so that laboratories have the correct formula to calculate total CBD.

A definition for “total THC” has been added and defines total THC as the molar sum of THC and THCA. Total THC is calculated using the following equation in which “M” is the mass or mass fraction of delta-9 THC or delta-9 THCA: M total delta-9 THC = M delta-9 THC + (0.877 x M delta-9 THCA). This definition is necessary so that laboratories have the correct formula to calculate total THC.

 

Authority: Section 26013, Business and Professions Code. Reference: Sections 26013 and 26100, Business and Professions Code.

What are the Chain of Custody requirements for a Testing Laboratory?

§ 5709. Chain of Custody (COC) Protocol

(a) The laboratory shall develop and implement a COC protocol to ensure accurate documentation of the transport, handling, storage, and destruction of samples.

(b) The COC protocol shall require the use of a COC form that contains, at a minimum, the following information:

(1) Laboratory’s name, physical address, and license number;

(2) Distributor’s name, physical address, and license number;

(3) Unique sample identifier;

(4) Date and time of the sample collection;

(5) Printed and signed names) of the distributor(s);

(6) Printed and signed names) of the sampler(s); and

(7) Printed and signed names) of the testing laboratory employee who received the sample.

(c) Each time the sample changes custody between licensees is transported, are destroyed, the date, time, and the names and. signatures of persons involved in these activities sha11 be recorded on the COC form.

Proposed Regs. – October 19, 2018

Subsection (a)(1) and (a)(2) have been deleted. New subsection (a)(1) consolidated the requirements of former (a)(1) and (a)(2) and revised them for clarity, to provide requirements for the transportation of cannabis samples. This is necessary to ensure that the rules for the movement of cannabis goods in a vehicle are consistent throughout the regulations.

Subsection (a)(4), formerly (a)(5), has been amended to remove vehicle from the term alarm system. This is necessary for consistency with other sections of the regulations.

Subsection (a)(6), formerly (a)(7) of this section has been amended by clarifying and specifying that the compliance referred to, is regulatory compliance, and by removing the language pertaining to travel from the laboratory’s licensed premises when engaged in the transportation of cannabis goods. This is necessary to streamline the provision, as such language is unnecessary, in indicating that the laboratory employee may travel back to its own licensed premises.

Subsections (a)(7)-(a)(11) have been renumbered to account for the consolidation of subsections (a)(1) and (a)(2).

Subsection (b)(1) has been amended to require proof that the laboratory is the registered owner under the Vehicle Code for each vehicle used to transport samples. This change is necessary for consistency with changes made under section 5312.

Subsection (d) has been amended to clarify that the information licensees must provide to the Bureau is the information required under subsection (c) of the section. Subsection (d) has also been amended to incorporate by reference a form for licensees to use to submit to the Bureau the required notifications in this section.

The reference section has been revised to correct a typographical error.

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.

Testing Laboratory

What are procedures for Samples obtained by a Testing Laboratory from a Distributor?

§ 5710. Laboratory Receiptof Samples-Obtained from a Distributor (a) The laboratory may accept and analyze a sample from a distributor for the required testing under section 5714 of this division only if there is an accompanying COC form for the sample. (b) The laboratory sha11 not analyze a sample obtained from a distributor, and the batch from which the sample was obtained may not be released for retail sale, if the any of the following occur: (1) The sample is received at the laboratory without the requisite COC form; (2) The tamper-evident material is broken prior to the sample being received at the laboratory; or (3) There is evidence of sample commingling, contamination, degradation, or a related occurrence rendering the sample unusable for analytical testing when the sample is received at the laboratory.

Proposed Regs. – Oct. 19, 2018

Subsection (a) has been revised to specify that the subsection applies to microbusinesses that have been authorized to engage in distribution. This is necessary to prevent potential confusion regarding which type of microbusiness the subsection may apply to.

Subsection (b) has been revised to specify that the subsection applies to microbusinesses that have been authorized to engage in distribution. This is necessary to prevent potential confusion regarding which type of microbusiness the subsection may apply to. Subsection (b) has also been revised to correct a typographical error.

Changes Made to Article 4. Standard Operating Procedures:

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.

Testing Laboratory

What is contained in a Testing Laboratory Certificate of Analysis?

§ 5726. Certificate of Analysis (COA) (a) The laboratory shall generate a COA only for each primary sample that the laboratory analyzes. (b) The laboratory shall, within 1 business day of completing analyses of a sample, both enter the COA information into the track and trace system and provide a copy of the COA to the requester. (c) The COA shall contain, at a minimum, the following information: . (1) Laboratory’s name, address, and license number; (2) Distributor’s name, address, and license number; (3) Cultivator’s, manufacturer’s, or microbusiness’ name, address, and license number; (4) Batch number of the.batch from which the sample was obtained; (5) Sample identifying information, including matrix type and unique sample identifiers; (6) Sample history, including the date collected, the date received by the laboratory, and the dates) of sample analyses and corresponding testing results; (7) For cannabis samples, the total weight, in grams, of both the primary sample and the total batch size; (8) For cannabis product samples, the total unit count of both the primary sample and the total batch size; (9) The identity of the analytical methods used and corresponding Limits of Detection (LOD) and Limits of QuantiCation (LOQ); and (10) Analytes detected during the analyses of the sample that are unknown, unidentified, or injurious to human health if consumed, if any. (d) The laboratory sha11 report test results for each primary sample on the COA as follows: (1) When reporting quantitative results for each analyte, the laboratory shall use the appropriate units of measurement as required under this chapter;

(2) When reporting qualitative results for each analyte, Che laboratory shall indicate “pass” or “fail”• (3) When reporting results for each test method, the laboratory sha11 indicate “pass” or “fail”; (4) When reporting results for any analytes that were detected below the analytical method LOQ, indicate ”

Proposed Regs. – October 19, 2018

Subsection (c) has been amended to specify the email address for which certificates of analysis (COA) are submitted to at the Bureau. This is necessary to ensure that licensees are correctly submitting the COAs, and that the Bureau is receiving them. Subsection (c) has also been amended to remove the requirement that the testing laboratories must provide the test results to other requestors.

Subsection (d) has been added to the section. The addition of subsection (d) has required the renumbering of subsequent subsections accordingly. New subsection (d) specifies and clarifies that the laboratory shall not release to any person any cumulative or individual test results prior to completing all analysis and providing the COA to the Bureau. This is necessary to ensure that test results remain confidential, pursuant to statutory requirements, and to preserve the integrity of the testing.

A new subsection (e)(1) has been added that requires the COA form to contain the term “Regulatory Compliance Testing” on the upper-right corner of each page of the COA, in a font no smaller than 14-point, with no text or images appearing above that term on any page of the COA. This is necessary to ensure that those reviewing the COA are aware it is a COA for regulatory compliance testing, and to preserve the integrity of the testing.

Subsections (e)(2) through (e)(7) have been renumbered and revised to clarify and specify that the address referred to, is the licensed premises address. This is necessary to ensure that the COA contains correct information that accurately reflects the licensee information.

Subsection (e)(2) has been amended to remove the term “physical” and replace it with “licensed premises” for clarity.

Subsection (e)(3) has been revised to specify that the subsection applies to microbusinesses that have been authorized to engage in distribution. This is necessary to prevent potential confusion regarding which type of microbusiness the subsection may apply to.

Subsection (e)(4) has been amended to remove the term “physical” and replace it with “licensed premises” for clarity.

Subsection (e)(5) has been revised to clarify that packaged cannabis goods must have a labeled batch number that matches the batch number of the COA. This is necessary to ensure that licensees and the Bureau are able to clearly identify the batches held by the licensee as well. This will also reduce the risk of potential error and confusion in matching up COAs with their respective batches.

Subsection (e)(8) has been renumbered and revised to clarify and specify that the picture on the COA of a sample must include an unobstructed image of the packaging if the sample is pre-packaged. This is necessary to ensure accurate identification of the sample and compliance with testing and labeling.

Subsection (f)(5) has been amended to clarify that the section does not apply to the reporting of cannabinoid results. Former subsection (f)(5) has been removed because it is no longer necessary due to the changes in label claim review.

 

Testing Laboratory

What is covered by Testing Laboratory post-testing analysis?

§ 5727. Remediation and Retesting (a) A harvest batch or cannabis product batch that has been additionally processed after a failed testing must be retested and successfully pass all the analyses required under this chapter. (b) A harvest batch or cannabis product batch that failed to test because of non-conformance with the labeled content may be relabeled so that the batch conforms with the labeled content. (c) A harvest or batch or cannabis product batch may only be remediated twice. If the batch fails after the second remediation attempt and the second retesting, the entire batch shall not be released for retail sale. (d) Within 1 business day of completing the required analyses of a sample obtained from a remediated harvest batch or remediated cannabis product batch, the laboratory sha11 enter the COA information into the track and trace system. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5728. Post-Testing Sample Retention (a) The laboratory shall retain the reserve sample, consisting of any portion of a sample that was not used in the testing process. The reserve sample shall be kept, at a minimum, for 45 business days after the analyses, after which time it may be destroyed and denatured to the point the material is rendered unrecognizable. (b) The laboratory shall securely store the reserve sample in a manner that prohibits sample degradation, contamination, and tampering. (c) The laboratory shall provide the reserve sample to the Bureau upon request.

Proposed Regs – October 19, 2018

Subsection (a) has been revised to remove the language indicating that edible cannabis products may not undergo additional processing after a failed laboratory test. This restriction is no longer in place. Although most edible cannabis products may not undergo remediation. In certain circumstances, limited forms of remediation may be performed on edible cannabis goods that have failed laboratory testing.

Subsection (b) of this section has been removed due to changes in the section 5303 which have rendered this subsection unnecessary. The other subsections of this section have been renumbered to account for the removal of subsection (b). Lastly clarification has been made in new subsection (b) to clarify that a microbusiness referenced in this section must be one that is authorized to engage in distribution. This change is necessary for consistency of terms used throughout the regulations.

Subsection (c) has been revised to clarify that the subsection applies only to failed batches.

Subsection (e) has been revised to correct grammatical errors.

Subsection (f) has been added to clarify that the section would not prevent a cannabis goods batch from being retested when the COA is 12 months old or older. This is necessary to clarify that cannabis batches that have a COA that has expired due to time, may be retested and sold.

Changes Made to Article 7. Laboratory Quality Assurance and Quality Control

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.

Testing Laboratory

What are the quality control requirements for Testing Laboratories?

§ 5729. Laboratory Quality Assurance (LQA) Program (a) The laboratory shall develop and implement a LQA program to assure the reliability and valiflity of the analytical data produced by the laboratory. The LQA program shall, at minimum, include a written LQA manual that addresses the following: (1) Quality control procedures; (2) Laboratory organization and employee training and responsibilities; (3) LQA objectives for measurement data; (4) Traceability of data and analytical results; (5) Instrument maintenance, calibration procedures, and frequency; (6) Performance and system audits; (7) Steps to change processes when necessary; (8) Record retenrion; (9) Test procedure standardization; and (10) Method validation. (b) The supervisory or management laboratory employee shall annually review, amend if necessary, and approve the LQA program and manual both when they are created and when there is a change in methods, laboratory equipment, or the supervisory or management laboratory employee. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5730. Laboratory Quality Control (LQC) Samples (a) The laboratory shall use LQC samples in the performance of each analysis according to the following specifications. (b) The labaratory shall analyze LQC samples in the same manner as the laboratory analyzes cannabis and cannabis product samples. (c) The laboratory shall use negative and positive controls for microbial testing. (d) The laboratory shall prepare and analyze at least one LQC sample for each analytical batch within each set of 20 samples for the following LQC samples:

(1) Method blank; (2) Continuing calibration verification (CCV); (3) Labaratory replicate sample; and (4) Matrix spike sample or matrix spike duplicate sample. (e) If the result of the analyses is outside the specified acceptance criteria in the following table, the laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria. Laborato uali Control Sam le Acce tance Criteria Method blank sample for chemical analysis Not to exceed LOQ Reference material and certified reference Percent recovery 80% – 120% material for chemical analysis Laborator re licate sample RPD no greater than 20% Matrix spike or matrix spike duplicate Percent recovery between 80% to 120% sample for chemical analysis CCV for chemical analysis Percent recovery between 80% to 120% Cannabis product field duplicate sam le RPD no greater than 20% Cannabis field du licate sample RPD no greater than 30% (fl The laboratory shall generate a LQC sample report for each analytical batch that includes LQC parameters, measurements, analysis date, and matrix. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5731. Limits of Detection (LOD) and Limits of Quantitafion (LOQ) for Quantitative Analyses (a) The laboratory shall calculate the LOD for chemical method analyses according to any of the following methods: (1) Signal-to-noise ratio afbetween 3:1 and 2:1; (2) Standard deviation of the response and the slope of calibration curve using a minimum of 7 blank samples; ar (3) A method published by the United States Food and Drug Administration (USFDA) or the United States Environmental Protection Agency (USEPA). (b) The laboratory shall calculate the LOQ for chemical method analyses according to any of the following methods: (1) Signal-to-noise ratio of 10:1, at minimum;

(2) Standard deviation of the response and the slope using a minimum of 7 blank samples calculated as follows: LOQ = (10 X standard deviation of the response) / slope of the calibration curve; or (3) A method published by the USFDA or the USEPA. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code. § 5732. Data Package (a) The laboratory shall generate a data package for each batch of samples that the laboratory analyzes. At a minimum, the data. package sha11 contain the following: (1) The name and address of the laboratory that performed the analytical procedures; (2) The names, functions, and signatures of the laboratory employees that performed the sample preparation, analyses, and reviewed and approved the data; (3) All batch sample results and batch LQC sample results; (4) Raw data, including inshument raw data, for each sample, if any; (5) Iush~i~menY test method with parameters, if any; (6) Inshument tune report, if any; (7) Instrument calibration data, if any; (8) LQC sample report with worksheets, forms, or copies of laboratory notebook pages containing pertinent information related to the identification and traceability of all reagents, reference materials, and standards used for analysis; (9) Analytical batch sample sequence, if any; (10) The field sample log and the COC form; and (11) The COA created as required under this chapter. (b) After the data. package is compiled, the supervisory ar management laboratory employee shall do the following: (1) Review the analytical results for technical correctness and completeness; (2) Verify that the results of each analysis carried out by the laboratory are reported accurately, clearly, unambiguously, and objectively; and (3) Approve the laboratory results by signing and daCing the data package prior to release of the data by the laboratory.

(c) The data package shall be kept for a minimum of 7 years and shall be made available upon request by the Bureau. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104, 26110 and 26160, Business and Professions Code. § 5733. Required Proficiency Testing (a) The laboratory shall participate in a proficiency testing program (“PT program”) provided by an organization that operates in conformance with the requirements of ISO/IEC 17043, at least once every six months after receiving ISO/IEC 17025 accreditation. (b) The laboratory shall participate in the PT program by following the laboratory’s existing SOPs for testing cannabis and cannabis products. (c) The laboratory shall rotate the PT program among the analytical methods in the laboratory’s scope of accreditation and among the employees who perform the test methods. (d) Laboratory employees who participate in a PT program shall sign the corresponding analytical reports or attestation statements to certify that the PT program was conducted in the same manner as the laboratory tests of cannabis and cannabis products. (e) A supervisory or management laboratory employee sha11 review and verify the accuiacy of results reported for all PT program samples analyzed. (fl The laboratory shall provide PT program results to the Bureau within 3 business days after the laboratory receives notification of their test results from the PT program provider. Authority;. Section 26013, Business. and Professions Code. Reference: Sections 26100 and 26110, Business and Professions Code. § 5734. Satisfactory and Unsatisfactory Proficiency Test Performance (a) The laboratory shall be deemed to have successfully participated in a PT program for an analyte tested in a specific method if the test results demonstrate a “satisfactory” or otherwise proficient performance determination by the PT program provider. (b) The laboratory may not report test results for analytes that are deemed by the PT program provider as “unacceptable,” “questionable,” “unsatisfactory”, or otherwise deficient. (c) The laboratory may resume reporting test results for analytes that were deemed “unacceptable,” “questionable,” “unsatisfactory”, or otherwise deficient, only if both of the following conditions are met: (1) The laboratory satisfactorily reFnedies the cause of the failure for each analyte; and (2) The laboratory submits, to the Bureau, a written report demonstrating how the laboratory has fixed the cause of the failure. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100 and 26110, Business and Professions Code.

Proposed Regs. – October 19, 2018

Subsection (a)(2) has been amended to include good laboratory practice as a requirement that must be addressed in the LQA manual. This change is necessary to ensure laboratories are utilizing good laboratory practice and to preserve the integrity of laboratory testing.

§ 5735. Internal audit (a) The laboratory shall conduct an internal audit at least once per year or in accordance with the ISO/IEC 17025 accrediting body’s requirement, whichever is more frequent: (b) The internal audit must include all of the components required by the ISO/IEC 17025 internal-audit standards. (c) Within 3 business days of complering the internal audit, the laboratory shall submit the results of the internal audit to the Bureau. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100 and 26104, Business and Professions Code. Article 8. Employee Qualifications § 5736. General Employee Qualifications (a) The laboratory may only employ persons who are at least 21 years of age. (b) The laboratory shall develop and implement an employee training program to ensure competency of employees for their assigned functions. (c) The laboratory shall ensure and document that each employee meets the employee qualifications. Authority: Section 26013, Business and Professions Code. Reference: Sections 26102 and 26104, Business and Professions Code. § 5737. Supervisor or Management Responsibilities and Qualifications (a) The laboratory shall employ a supervisor or management employee who must be responsible for: (1) Overseeing and directing the scientific methods of the laboratory; (2) Ensuring that the laboratory achieves and maintains a laboratory quality assurance program as required by section 5729 of this division; and (3) Providing ongoing and appropriate training to laboratory employees. (b) To be considered qualified, the supervisar ar management employee must have earned, at minimum: (1) A doctoral degree in biological, chemical, agricultural, environmental, ar related sciences from an accredited college or university; (2) A master’s degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university, plus at least 2 years of full-time practical experience; or (3) A bachelor’s degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university, plus at least 4 years of full-time practical experience.

Authority: Section 26013, Business and Professions Code. Reference: Sections 26102 and 26104, Business and Professions Code. § 5738. Analyst and Sampler Qualifications (a) The laboratory shall employ an analyst who, at minimum, must have either: (1) Earned a master’s degree or a bachelor’s degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university; or (2) Completed 2 years of college or university education that included coursework in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university, plus at least 3 years o~ full-time practical experience. (b) The laboratory shall employ a sampler who, at a minimum, must have either: (1) Completed 2 years college or university education; or (2) Earned a High School Diploma or passed a General Educational Development or High School Equivalency exam, plus at least 1 year of full-time practical experience.

Proposed Regulations – October 19, 2018

Subsection (e) has been amended to incorporate by reference new Notification and Request Form, BCC-LIC-027- (New 10/18), for licensees to use to submit to the Bureau the notifications required under this section. This is necessary for consistency and clarity throughout the regulations.

Authority: Section 26013, Business and Professions Code. Reference: Sections 26102 and 26104, Business and Professions Code.

What are the record retention and enforcement requirements for Testing Laboratories?

§ 5739. Records All testing laboratory-specific records described in this chapter shall be maintained in accordance with section 5037 of this division. Authority: Section 26013, Business and Professions Code. Reference: Section 26160, Business and Professions Code.

§ 5800. Right of Access (a) The Bureau, aasd its authorized representatives, shall have full access to inspect and: (1) Enter onto any premises licensed by the Bureau. (2) Test any vehicle ar equipment possessed by, in control of, or used by a licensee or their agents and employees far the purpose of conducting commercial cannabis activity. (3) Test any cannabis goods or cannabis-related materials ar products possessed by, in control of, ar used by a licensee or their agents and employees for the purpose of conducring commercial cannabis activity. (4) Copy any materials, books, or records of any licensee ar their agents and employees.

(b) Failure to cooperate with and participate in any Bureau investigation pending against the licensee may result in a licensing violation subject to discipline. This subsection shall not be construed to deprive a licensee of any privilege guaranteed by the Fifth Amendment to the Constitution of the United States, or any other wnstitutional or statutory privileges. This subsection shall not be construed to require a licensee to cooperate with a request that would require the licensee to waive any constitufional or statutory privilege or to comply with a request for information or other matters within an unreasonable period of time in light of the time constraints of the licensee’s business. Any constitutional or statutory privilege exercised by the licensee shall not be used against the licensee in a regulatory or disciplinary proceeding against the licensee. (c) The Bureau, and its authorized representafives, shall have the riglxts of access under subsection (a), during any inspection, investigation, review, or audit, or as otherwise allowed by ]aw. (d) Prior notice of an inspection, investigation, review, or audit is not required. (e) Any inspection, investigation, review, or audit of a licensed premises shall be conducted anytime the licensee is exercising privileges under the license, or as otherwise ageed to by the Bureau and the licensee or its agents, employees, or representatives. Authority: Section 26013, Business and Professions Code; Reference: Sections 26012 and 26015, Business and Professions Code. § 5801. Notice to Comply (a) The Bureau may issue a notice to comply to a licensee for violations) of the Act or regulations observed during an inspection. (b} T1~e notice to comply shall be in writing and describe the nature and facts of each violariou, including a reference to the statute or regulation violated, and may indicate the manner in which the licensee must correct the violafion(s) to achieve compliance. (c) The Bureau will serve the notice Yo comply prior to leaving the licensed premises afrer the inspection on any Iicensee, employee, agent, or person delegated by any of the aforementioned persons, to facilitate the inspection or accept such notice, or wi11 mail the notice to comply within 15 calendar days of the last date of inspection. (d) The notice to comply shall.inform the licensee that the lioensee may, within 15 calendar days from Che date of personal service or mailing of the notice to comply, sign and return the noflce to comply declaring under penalty of perjury that each violation was corrected and describing how compliance was achieved. (e) Failure to correct the violarion(s) in the notice to comply may result in a disciplinary action. Authority: Section 26013, Business and Professions Code; Reference: Sections 26012 and 26018, Business and Professions Code.

Proposed Regs. – October 19, 2018

Subsection (a)(5) has been added to specify that the Bureau may collect evidence related to any alleged violation of the Act or the regulations for the purpose of preserving such evidence during the course of investigation and subsequent disciplinary proceedings. This subsection is necessary to ensure that evidence can be preserved by the Bureau during the course of an investigation and ensures that evidence cannot be destroyed by a licensee that is being investigated.

Subsection (c) has been revised, to clarify and specify the access rights of the Bureau, to full and immediate access, as allowed by law. This is necessary to clarify and specify that there are limited restrictions as to when and how the Bureau may conduct an inspection, audit, review, or investigation, and to ensure access allows the Bureau to appropriately address any immediate safety concerns.

The reference section has been revised to correct a typographical error.

§ 5801. Notice to Comply

Subsection (a) has been amended to add that the notice to comply may also be issued for violations discovered during an investigation as well as observed during an inspection. This is necessary to ensure that the Bureau has the ability to assist licensees in coming into compliance with all laws and regulations and that licensees have an opportunity to correct any violations, however, discovered, before fines are assessed through the citation process or disciplinary action, or other administrative or civil action.

Subsection (c) is revised, to streamline the language, regarding whom may be delegated by a licensee, employee, or agent for purposes of serving a notice to comply. This is necessary to provide clarification and avoid any confusion or ambiguity. This subsection is also revised to make consistent the changes to subsection (a) relating to violations discovered during an investigation. This is necessary to clarify when a notice to comply can be served or delivered, specifically, 15 calendar days after the last date of inspection or discovery of the violation.

Subsection (d) has been revised to change the notification requirement from 15 days to 20 days. This is necessary as the Bureau has determined that requiring notice within 15 days may be too onerous and 20 days would allow the licensee more time while not negatively impacting the Bureau’s ability to regulate effectively.

§ 5802. Citations; Orders of Abatement; Administrative Fines (a) The Bureau may issue citations containing orders of abatement and fines against a licensee, or an unlicensed person, for any acts or omissions which are in violation of any provision of the Act or any regulation adopted pursuant thereto. (b) The Bureau may issue a citation udder this section to a licensee for a violation of a term or condition contained in a decision placing that licensee on probation. (c) Each citation: (1) Sha11 be in writing. (2) Shall describe with particularity the nature of the violation, including a reference to the law ar regulation determined to have been violated. (3) May contain an assessment of an administrative fine of up to $5,000, and/ar an order of abatement fixing a reasonable time for abatement of the violation; (4) Shall be served personally or by certified mail; and (5) Shall inform the licensee or person that he or she may request an informal conference, or contest the citation, or both, pursuant to section 5803. (d) Failure to pay a fine within 30 calendar days of the date of assessment, mIless the citation is being contested, may result in further action being taken by the Bureau including; but not limited to, suspension or revocation of a license. If a citation is not appealed and the fine is not paid, the full amount of the assessed fine shall be added to the fee for renewal of the license. A license shall not be renewed without the payment of the renewal fee and fine. (e) The amount of any fine to be levied by the Bureau shall take into consideraTion the factors listed in subdivision (b}(3) of Section 125.9 of the Business and Professions Code. (fl Nothing in Plus section shall be deemed to prevent the Bureau from filing an accusation to suspend or revoke a license where grounds for such suspension or revocation exist. Authority: Sections 125.9 and 26013, Business and Professions Code. Reference: Sections 125.9, 148, 149 and 26012, Business and Professions Code. § 5803. Contesting Citations (a) A cited licensee or person may, within 30 calendar days of service of the citation, contest the citation by requesting a hearing in writing to the Bureau or such hearing is waived. The hearing shall be conducted in accordance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of the Government Code.

(b) In addition to requesting a hearing provided for in subsection (a) of this secrion, the cited licensee or person may, within 15 calendaz days after service of the citation, submit a written request for an informal conference with the Bureau regarding the acts or omissions charged in the citation. (c) The Bureau shall, within 15 calendar days from receipt of the written request, hold an informal conference with the licensee or person cited, and/or his or her legal counsel or authorized representative. (d) At the conclusion of theinformal conference, the Bureau may affirm, modify, or dismiss the citation, including any fines levied or orders of abatement issued. A written decision stating the reasons for the decision shall be mailed to the cited licensee or person and his or her legal counsel, if any, within 15 calendar days from the date of the informal conference. This decision shall be deemed to be a final order with regard to the citation issued, including the levied fine and the order of abatement, if any. (e) If the citation is dismissed, any request for a hearing shall be deemed withdrawn. ff the citation is affirmed or modified, the cited licensee or person inay, in his or her discretion, withdraw the request for a hearing or proceed with the administrative hearing process. (~ If tt~e citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and new citation issued. If a hearing is requested for the subsequent citation, it shall be requested within 30 calendar days in accordance with subdivision (b)(4) of section 125.9 of the Business and Professions Code. Authority: Section 26013, Business and Professions Code. Reference: Sections 125.9, 26012 and 26016, Business and Professions Code. §_5804. Citation Compliance. (a) The time to abate or conecC a violation as provided for in an order of abatement maybe extended for good cause. If a cited licensee or person who has been issued an order of abatement is unable to complete the correction within the time set forth in the citation because of conditions beyond his ar her control after the exercise of reasonable diligence, the licensee or person cited may request an extension of rime from the Bureau in which to complete the correction. Such a request shall be in writing and “shall be made within the time set forth for abatement. (b) When a citation is not contested, or if it is appealed and the person cited does clot prevail, failure to abate the violation within the time allowed or pay a fine that was imposed shall constitute a violation and a failure to comply with the citarion or order of abatement. (e) Failure to timely comply with an order of abatement or pay a fine that was imposed may result in further action being taken by the Bureau, including, but not limited to, suspension or revocation of a license, or further administrative or civil proceedings.

Proposed Regs. – October 19, 2018

Subsection (c) is revised, by restructuring the subsection to provide additional clarity about what each citation must contain. The revisions do not make any substantive changes to the requirements. This is necessary to avoid any confusion or ambiguity as to what information is to be contained in a citation.

Subsection (e) is revised, to clarify and specify that the factors under Business and Professions Code section 125.9 used to assess a fine, are for fines contemplated and issued under this section. Such changes are necessary for clarity and consistency of terminology within the Bureau’s regulations.

The reference section has been revised to correct a typographical error.

§ 5803. Contesting Citations

Subsection (a) is revised, by restructuring the subsection to provide clarity about the process to contest a citation. The revisions do not make any substantive changes to process. This is necessary to avoid any confusion or ambiguity as to the process.

§ 5806. Attire and Conduct

Subsection (b) is revised, to correct a typing error, by amending “(a)(1)” to “(a),” as subsection (a)(1) does not exist.

§ 5807. Entertainers and Conduct

Subsection (b) is revised, by removing “above” and replacing with “in this section,”  for clarity regarding the prohibited activities.

§ 5809. Disciplinary Actions

Subsection (a) is revised, to clarify and specify that a license means a licensee. This revision is necessary for clarity and consistency of terms in the regulations.

Subsection (c) has been revised to correct a typographical error.

The reference section has been revised to correct a typographical error.

§ 5810. Interim Suspension

Subsection (b) has been revised to correct a typographical error.

The reference section has been revised to correct a typographical error.

§ 5811. Posting of Notice of Suspension

This section has been amended to incorporate by reference new Notification and Request Form, BCC-LIC-027- (New 10/18), for licensees to use to submit to the Bureau the notifications required under this section. The inclusion of a form was necessary to guide applicants and ensure they provide sufficient information for the Bureau to consider. The form also streamlines the notification process by assuring that applicants are able to fulfill its notification requirements without having to complete additional paperwork.

§ 5812. Posting of Notice of Revocation

Subsections (a) and (c) are revised, to clarify and specify that the signage required for a revoked license is on the premises where the revoked license was held. This is necessary to avoid any confusion or ambiguity as to whether the revoked license remains active or in use during the requirement to post notice.

Subsection (e) is revised, by adding “the notice” to the item to be displayed, to clarify and specify, that the failure to display, pertains to the notice referenced in the section. This is necessary to avoid confusion or ambiguity as to what is required to be displayed under the subsection.

Subsection (f) has been revised to incorporate by reference new Notification and Request Form, BCC-LIC-027- (New 10/18), for licensees to use to submit to the Bureau the notifications required under this section. The inclusion of a form was necessary to guide applicants and ensure they provide sufficient information for the Bureau to consider. The form also streamlines the notification process by assuring that applicants are able to fulfill its notification requirements without having to complete additional paperwork.

 

Authority: Section 26013, Business and Professions Code. Reference: Sections 125.9 and 26012, Business and Professions Code.

What are Standard Operating Procedures for a Testing Laboratory?

§ 5711. Laboratory Analyses Standard Operating Procedures (a) The laboratory shall develop, implement, and maintain written standard operating procedures (SOP) for the following laboratory processes: (1) Sample preparation. Sample preparation SOP(s) sha11 address the following: (A) Sample homogenization; (B) Handling and storage; (C) Preservation; and (D) Hold time. (2) Test methods. Each test method SOP shall address the following: (A) Test method name; (B) Applicable analytes and matrices; (C) Method sensitivity; (D) Potential interferences with the analysis, if any; (E) Analytical instruments used for testing; (F) Types, frequency, and acceptance criteria for quality control samples; (G) Types, frequency, and acceptance criteria for calibration standards; {H) Procedure for analyzing analytical batch samples; (I) Calculation of results, if any; and (J) Reagent, solution, standards, and reference material preparation, if any. (b) The supervisory or management laboratory employee shall review, approve, sign, and date each SOP and each revision thereto. (c) The laboratory shall keep each SOP at the laboratory premises and ensure that each SOP is accessible to laboratory employees during operating hours (d) The laboratory shall make each SOP available for inspection by the Bureau upon request, as well as any other SOPs associated with the licensee’s ISO/IEC 17025 certificate of accreditation.

Proposed Regs. – October 19, 2018

The Sample Preparation -Standard Operating Procedures Form, BCC-LIC-022 (New 7/18) was amended to correct for typographical and grammatical errors. Specifically, section 5 for the signature of the supervisory or management laboratory employee was amended to section 4, to correct the numbering of the section.

This section has been revised to reorganize the content into subsections. This is necessary to provide additional clarity.

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26102, 26104 and 2611 Q Business and Professions Code…

 

§ 5712. Test Methods (a) The laboratory shall develop, implement, and validate test methods for the analyses of samples as required under this division. (b) To the extent practicable, the laboratory test methods sha11 comport with the following guidelines: (1) US Food and Drug Administration’s Bacterial Analytical Manual, 2016; (2) AOAC International’s Official. Methods of Analysis for Contaminant Testing ofAOAC International, 20th Edition, 2016; and (3) United States Pharmacopeia and the National Formulary’s Methods of analysis for .Contaminant Testing, 2016.

Proposed Regs. – October 19, 2018

This section has been amended by adding Section 26012 of the Business and Professions Code to the reference section. This change is necessary for accuracy.

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.

§ 5713. Validation of Test Methods (a) The laboratory may use a non-standard, amplified, or modified test method or a method that is designed or developed by the laboratory to validate the methods for. analyses of samples. (b) The laboratory shall follow the guidelines set forth in the US Food and Drug Administration’s Guidelines for the Validation of Methods for the Detection of Microbial Pathogens in Foods and Feeds, 2nd Edition, 2015, incorporated herein by reference, to validate test methods for the microbial analysis. (i) The laboratory shall include and address the criteria listed in the following table when validating test methods for microbial analyses of samples. Criteria Requirement Number of tar et or anisms; inclusivity 5 Number of non-target organisms; exclusivity 5 Number of analyte levels per. matrix. Qualitative methods 3levels: high and low inoculum levels and 1 uninoculated level Number of analyte levels per matrix: Quantitative methods 4levels: low, medium and high inoculum levels and 1 uninoculated level Re licates er food at each level tested 2 or more replicates per level (c) The laboratory shall follow the guidelines set forth in the US Food and Drug Administration’s Guidelines for the Validatzon of Chemical Methods for the FDA FVM Program, 2nd Edition, 2015, incorporated herein by reference, to validate tesf methods for chemical analysis of samples.

(1) The laboratory shall include and address the following criteria to validate test methods for chemical analyses of samples: (A) Accuracy; (B) Precision; (C) Linearity and range; (D) Calibration standard; (E) Sensitivity and selectivity; (F) Limit of detection and limit of quantitation; (G) Recovery; (H) Reproducibility; and. (I) Robustness. (d) ff available, the laboratory shall use cannabis reference materials or certified reference materials to validate test methods.

Proposed Regs. – October 19, 2018

Subsection (b) has been revised to provide additional clarification on how licensees are expected to use the table provided in the section to validate test methods for microbial analyses of samples. Subsection (b)(1) has been deleted as the information has not been included in subsection (b).

Subsection (c)(1)(C) has been amended by renumbering old subsection (c)(1)(C)(ii) to new subsection (c)(1)(C)(iii) and adding new subsection (c)(1)(C)(ii), to clarify and specify that linear regression or quadratic regression shall only be used for calibration curves. This is necessary to ensure that laboratories are appropriately calculating calibration curves. This section has also been amended to incorporate by reference the Notification and Request Form, BCC-LIC-027 (New 10/18), for licensees to use to submit to the Bureau the required notifications in this section.

Subsection (c)(D)(ii) has been revised to include the requirement that the percent recovery must be between 70% to 130%. This is necessary to ensure consistency with section 5730, subsection (g).

Subsection (d)(8) has been amended to incorporate by reference the Notification and Request Form, BCC-LIC-027 (New 10/18), for licensees to use to submit to the Bureau the required notifications in this section. This is necessary for consistency throughout the regulations.

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.

What is Required Testing for a Testing Laboratory?

Testing Laboratory – Required Analysis Testing

Testing Laboratory – Required Analysis Testing Procedures are discussed in this section

§.5714. Required Testing

(a) The laboratory shall test each sample for the following:

(1) Cannabinoids;

(2) Foreign material;

(3) Heavy metals;

(4) Microbial impurities;

(5) Mycotoxins;

(6) Moisture content and wafer activity;

(7) Residual pesticides; (8) Residual solvents and processing chemicals;

(9) If applicable, terpenoids; and

(10) If applicable, homogeneity.

(b) The laboratory shall report the results of each analysis performed by the laboratory on the certificate of analysis.

Proposed Regs. – Oct. 19, 2018

The section has been amended by revising the numbering of the subsections and adding a new subsection (a) that specifies and clarifies that all sample increments collected must be homogenized prior to sample analyses, notwithstanding foreign material testing. This is necessary to ensure that sample increments are homogenized, to preserve the integrity of testing, and standardize sample preparation procedures.

A new subsection (d) has been added to clarify and specify that the laboratory collecting the representative sample, is to be the laboratory that completes all the required testing for each representative sample for regulatory compliance testing. This is necessary to ensure that representatives samples are not being tested by different licensed laboratories and are only being tested by the laboratory collecting the sample, and to preserve the integrity of testing.

The reference section has been revised to correct a typographical error.

Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
Requirements
  • ISO/IEC 17025 accreditation
  • Collect samples from each batch at the  distributor’s premises
  • Harvest batch (prepacked or unpacked) equal to no  more than 50 pounds
  • Manufactured product batch equals no more than  150,000 units
  • Must develop and implement a chain of custody protocol to document the transportation, handling, storage, and  destruction of samples
  • Must generate a certificate of analysis for each primary sample the lab analyzes

 

  • § 5708. Cannabis Product Batch Sampling

(a) The sampler shall collect both a primary sample and a field duplicate sample from each cannabis product batch. The sampler shall collect the field duplicate sample contemporaneous Co, and in the same manner as, a collection of the primary sample.

(b) The sampler may collect a greater number of increments per primary sample and field duplicate sample if necessary to perform the required testing or to ensure that the samples obtained are representative.

(c) The cannabis product batch from which a primary sample and a field duplicate sample are obtained sha11 contain no more Phan 150,000 units. Laboratory analyses of a sample collected from a cannabis product batch containing more than 150,000 units shall be deemed invalid and the cannabis product batch from which the primary sample and a field duplicate sample were obtained may. not be released for retail sale.

(d) The sampler shall obtain a primary sample and a field duplicate sample of cannabis product by collecting, at the minimum, the mm~ber of increments per sample relative to the cannabis product batch size as listed in the following table. Each increment consists of 1 packaged unit. Cannabis Product Batch Size Number of Increments

Proposed Regs. – October 19, 2018

Subsections (b) and (d) of this section have been amended, by adding “sample” before increments, to clarify and specify that the increments referred to are sample increments.

Subsection (c) has been revised to change the term “may not” to “shall not.” This is necessary for the consistent use of terms throughout the regulation.

Lab Licensing

Bureau of Cannabis Controlhttps://bcc.ca.gov

 

Testing Transition Requirements – Updated

Cannabis Licensing 

Bureau Cannabis Control

FAQ’s

Testing Labs

Quality Control             Operating Standards      Record Retention