WSR 16-24-094 PROPOSED RULES LIQUOR AND CANNABIS BOARD [Filed December 7, 2016, 10:50 a.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 16-09-117 and 16-08-127.
Title of Rule and Other Identifying Information: New WAC 314-55-0995 Laboratory certification and accreditation requirements, 314-55-1025 Proficiency testing, 314-55-1035 Laboratory certification—Suspension and revocation, 314-55-108 Pesticide action levels; and amending WAC 314-55-101 Sampling protocols, 314-55-102 Quality assurance testing, and 314-55-103 Good laboratory practice checklist.
Hearing Location(s): Washington State Liquor and Cannabis Board (WSLCB), Board Room, 3000 Pacific Avenue S.E., Olympia, WA 98504, on January 11, 2016 [2017], at 10:00 a.m.
Date of Intended Adoption: On or after January 25, 2017.
Submit Written Comments to: Joanna Eide, Policy and Rules Coordinator, P.O. Box 43080, Olympia, WA 98504, e-mail rules@lcb.wa.gov, fax (360) 664-9689, by January 11, 2016 [2017].
Assistance for Persons with Disabilities: Contact Joanna Eide by January 4, 2016 [2017], (360) 664-1622.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of this proposal is to make necessary rule changes for laboratory certification requirements, proficiency testing (PT), pesticide action levels, requirements to promote lab accuracy and consistency, and quality assurance (QA) requirements.
Reasons Supporting Proposal: Rule changes are needed to protect consumer safety through ensuring laboratories employ appropriate testing methodologies and achieve accurate testing results for marijuana. Creating PT requirements to achieve and maintain certification and parameters for laboratories will promote accuracy and accountability in marijuana testing by certified laboratories. Additionally, current permanent rules provide how a laboratory may be certified by WSLCB, but do not contain provisions on what a laboratory must do to remain certified or how WSLCB may suspend or revoke the certification of a laboratory. WSLCB needs the authority to suspend or revoke the certification of a laboratory that does not follow rule requirements for testing or for those laboratories that do not consistently achieve accurate testing results. Rules for pesticide action levels are needed for pesticides not allowable for use in the production of marijuana. Currently, permanent rules contain a zero tolerance for disallowed pesticides, which is unworkable and virtually untestable. WSLCB needs action levels for pesticides to determine when a sample should fail QA testing and when a recall should be initiated.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: WSLCB, governmental.
Name of Agency Personnel Responsible for Drafting: Joanna Eide, Policy and Rules Coordinator, 3000 Pacific Avenue S.E., Olympia, WA 98504, (360) 664-1622; Implementation: Marijuana Examiners Unit, 3000 Pacific Avenue S.E., Olympia, WA 98504, (360) 664-1600; and Enforcement: Justin Nordhorn, Chief Enforcement, 3000 Pacific Avenue S.E., Olympia, WA 98504, (360) 664-1726.
A small business economic impact statement has been prepared under chapter 19.85 RCW.
Small Business Economic Impact Statement
Chapter 19.85 RCW, Regulatory Fairness Act, requires an analysis of the economic impact proposed rules will have on regulated businesses. Preparation of a small business economic impact statement (SBEIS) is required when proposed rules will impose more than minor costs on businesses.
"Minor cost" means a cost that is less than one percent of annual payroll or the greater of either .3 percent of annual revenue or $100.
"Small business" means any business entity that is owned and operated independently from all other businesses and has fifty or fewer employees.
Describe the Proposed Rule Changes, Including a Brief History of the Issue and an Explanation of Why the Proposed Rule Change is Needed:
Rule changes are needed regarding laboratory certification requirements, PT, pesticide action levels, requirements to promote lab accuracy and consistency, and QA requirements. Rule changes are needed to protect consumer safety through ensuring laboratories employ appropriate testing methodologies and achieve accurate testing results for marijuana. Creating PT requirements to achieve and maintain certification and parameters for laboratories will promote accuracy and accountability in marijuana testing by certified laboratories. Additionally, current permanent rules provide how a laboratory may be certified by WSLCB, but do not contain provisions on what a laboratory must do to remain certified or how WSLCB may suspend or revoke the certification of a laboratory. WSLCB needs the authority to suspend or revoke the certification of a laboratory that does not follow rule requirements for testing or for those laboratories that do not consistently achieve accurate testing results.
Rules for pesticide action levels are needed for pesticides not allowable for use in the production of marijuana. Currently, permanent rules contain a zero tolerance for disallowed pesticides, which is unworkable and virtually untestable. WSLCB needs action levels for pesticides to determine when a sample should fail QA testing and when a recall should be initiated.
WSLCB convened an informal work group to gather information and receive recommendations for the changes proposed in this rule making. The work group was comprised of WSLCB staff, certified labs, marijuana businesses, WSLCB's certifying and auditing vendor, and other state agencies, including the department of health, the department of agriculture, and the department of ecology. Several meetings were held over a period of six months to gather information and suggestions for this rule making in addition to the comments and recommendations received as part of the rule-making process.
Identify which Businesses are Required to Comply with the Proposed Rule Changes. How many businesses of each type are involved? (Use the North American Industry Classification System (NAICS) codes where possible): There are no NAICS codes for marijuana production, processing, or retail businesses. There is no current data on payroll for marijuana production, processing, retail, or testing businesses. Certified labs and licensed producers and processors will be required to adhere to the proposed rule changes.
The following numbers are based on information pulled on December 6, 2016.
Producers by Tier:
Summary of the Compliance Requirements Included in the Proposed Rule Changes: The proposed rules include the following compliance requirements:
Analyze the Probable Cost of Compliance. Identify the probable costs to comply with the proposed rule changes, including: Cost of equipment, supplies, labor, professional services and increased administrative costs; and whether compliance with the proposed rule will cause businesses to lose sales or revenue: Lab equipment cost estimates for testing water activity rate (new): $1200-$4000. These equipment costs are one-time costs. Ongoing costs are estimated at ten percent of the initial equipment cost per year, at a rate of $120-$400.
Lab equipment costs for mycotoxin testing (new): Mycotoxin testing can be accomplished with a liquid chromatography system with a mass spectrometer (LC/MS) or by purchasing enzyme-linked immunosorbent assay (ELISA) kits. It is estimated that about half of the certified labs could use existing equipment to perform these new testing requirements.
Increased inspections for auditing of certified labs due to changes with the good laboratory practice checklist in WAC 314-55-103. These changes also include increased recordkeeping requirements and may require increased training of employees of certified labs.
Increased residual solvent testing requirements will also result in some additional administrative and operational costs for certified labs.
Producers and processors will have administrative costs to adjust to the proposed changes in sample deduction. This will vary depending on the producer. Adjustments are intended to reduce self-selection bias with sample deduction. Changes include requirements for each sample to be packaged in a separate container to increase accurate assessment of lots and batches. Labs may collect samples if they choose, which may result in an increased cost to producers and processors should they agree to this, but would be an optional cost.
Some labs estimate the need for all additional equipment to adjust to the changes in the proposed rules will cost around $500,000. If this is true, they estimate that if sample volumes increase at a rate of fifty percent per year and assume that labs intend to aim for a twenty-four month return on investment for purchasing that equipment, the five labs that do the majority of the QA testing in Washington will need to increase average per sample price for QA testing by $17.42 to meet that return on investment goal. However, WSLCB's certifying and auditing vendor believes that around half of the currently certified labs already have the equipment to comply with the majority of the proposed changes in this rule making.
Professional services: Labs will need to use professional services of WSLCB approved PT providers. PT – currently required by emergency rule. This rule making will make those requirements permanent. Under these proposed rules, labs must successfully complete PT for each field of testing the lab seeks to be certified for. Certified labs must participate in two rounds of PT per year for each field of testing and maintain a passing score on an ongoing basis, in a minimum of two out of three successive rounds of PT. Currently, there are three PT programs available: Potency analysis, microbial analysis, and residual solvents. As more PT programs for other fields of testing become available, certified labs will be required to complete those programs for the fields of testing that the lab is certified for. Costs for compliance should decrease over time as more PT programs become available on the market and competition increases. Examples of PT testing costs range from $75 for one calibration to $575 for a blind PT for THC and cannabinol. Many PT rounds are priced around $250 per round, though some are higher.
Marijuana producers and processors will have to continue to use the services of one or more certified labs to provide required QA tests under current rules and the proposed changes to rules in this rule making.
Whether the increased costs will result in lost sales or revenue: Licensed marijuana businesses may see a small loss comparative to overall wholesale value of lots in sales due to increased sampling amounts as proposed in the rule changes. However, these losses can be made up by passing costs along to the ultimate consumer at retail. Increased testing costs and administrative costs for certified lab compliance with the changes may be offset by increases to testing charges to licensed marijuana producers and processors. These increased costs again can be passed on to consumers at retail.
Analyze Whether the Proposed Rule Changes May Impose More Than Minor Costs on Businesses in the Industry: "Minor cost" means a cost that is less than one percent of annual payroll or the greater of either .3 percent of annual revenue or $100. Based upon the available data, costs of compliance and administrative costs, increases to sample quantities and amounts, and increases to testing requirements, WSLCB concludes that the proposed rule changes will result in more than minor costs to businesses in the marijuana industry.
Average wholesale price per gram of marijuana was $2.98 over the past year (2016). The current average retail price of marijuana per gram, including excise tax, was $8.61 in the month of October 2016. On average, the price per gram of marijuana from October 2015 to October 2016 was approximately $8.67/gram. These average values inform a conclusion that the adjustments to sampling numbers and sizes will result in the following costs to producers and processors in losses to wholesale sales:
The amount of costs incurred will depend on the amount of marijuana produced or processed by licensees, which varies by licensee.
According to industry and through researching pricing for QA tests that currently certified labs offer, pricing estimated averages for QA testing under current rules and the proposed changes in this rule making are as follows:
Some industry members noted that the proposed requirements for three separate potency tests may not result in price increases as labs may choose to offer volume discounts for potency tests. Additionally, many labs include moisture testing without increased costs when testing for the full battery of other tests required. How much increased costs for testing incurred depends on the individual licensee production amounts and processed material amounts and type of product. For producers, this will be dependent on the tier level the producer falls under and whether the producer harvests year-round or on a seasonal basis (indoor grow vs. outdoor grows). For processors, this is dependent on the amount and type of products processed. Four thousand two hundred forty-three samples were tested by certified labs in June 2016.
Costs will likely be passed along to the ultimate consumer at retail. Some retailers have stated screening marijuana products for toxins is a selling point and converts customers to the regulated marijuana market rather than the illicit market.
Determine Whether the Proposed Rule May Have a Disproportionate Impact on Small Businesses as Compared to the Ten Percent of Businesses That are the Largest Businesses Required to Comply with the Proposed Rule: It is likely that the QA testing changes will disproportionately impact smaller producers and processors. Smaller harvests will be subject to the increased sampling sizes and increased testing requirements, and the sample amounts will maximize cost-savings when larger lots (fifteen lbs.) are used. Smaller harvests of five lbs. or less will not be able to take advantage of the cost-savings measures with sampling at larger lot sizes. Increased sample size amounts will also result in higher costs for compliance since that will take material out of the market (otherwise could be sold) for testing purposes.
It is estimated that virtually all of the certified labs qualify as small businesses. For this reason, all changes to rule requirements will impact those small businesses.
If the Proposed Rule Changes Have a Disproportionate Impact on Small Businesses, Identify the Steps Taken to Reduce the Costs of the Rule on Small Businesses. If the costs cannot be reduced provide a clear explanation of why or the justification for not reducing costs: The WSLCB initially considered adopting a requirement that labs seeking certification to test marijuana and current certified labs achieve ISO 17025 accreditation as a condition of acquiring and maintaining WSLCB certification. The costs associated with achieving ISO accreditation would have been quite substantial and ongoing and labs expressed concerns relative to that. Instead, WSLCB worked with its certifying and auditing vendor to incorporate certain provisions (section 5.4 – Test and Calibration Methods and Method Validation) from ISO accreditation into its good laboratory standards checklist, rather than requiring ISO accreditation. This change was also recommended by certified labs that participated in informal work group discussions. This change will help to achieve the goals of promoting good laboratory practices, sound testing methodologies, consistency, and accuracy while avoiding the higher costs of ISO accreditation in addition to lab certification costs. The new items in the good laboratory standards checklist in WAC 314-55-103 will increase costs and compliance requirements for labs, including increased auditing costs, but at a lesser expense than ISO accreditation.
Increased sample sizes and number of samples required for testing, specifically for potency testing may result in initial losses of wholesale sales, but may ultimately be made up through adjustments to pricing based on increased costs and passed along to the consumer at retail. Given that the average price per gram at retail is currently $8.67, the increased price at wholesale and at retail should be comparatively low. Some industry members estimated that this increase at wholesale could be around $0.10 per gram. Additionally, larger lot sizes may make inventory management easier for those producers who have harvests large enough to create larger lots. If this occurs, it could mean reductions to operational and administrative costs, which could result in more mitigating cost savings. Even smaller producers and processors may benefit in potential cost savings due to the increased flexibility in lot sizing depending on business decisions made.
Added mycotoxin testing as a required QA test. This change is proposed as a response to removal of certain microbiological test requirements. This adjustment does not result in a net increase to testing costs, and some industry members estimate that licensed marijuana producers in Washington could collectively save upwards of $30 million due to the adjustments in the microbiological limits tests. However, due to other changes in QA testing requirements, specifically with the requirement of three potency tests rather than one, industry members estimate a twenty-five percent increase to testing costs. This estimate may be higher than actual cost impacts due to mitigating factors, such as the removal of some testing requirements, flexibility of lot sizes, and ability to pass along additional costs to consumers. Some industry members have expressed that the monetary benefit of the proposed rules to the marijuana producers may "far outweigh any costs associated with enhanced quality assurance."
Adjustments to when testing must be performed are proposed to allow for greater flexibility while still ensuring the proper tests are performed prior to products being sold at retail. This change was made to promote flexibility aimed at cost savings. Specifically, it will avoid having to test certain products (concentrates) twice prior to being sold at retail.
Costs will likely be passed along to consumers at retail, which is a mitigating factor. The additional costs associated with the increased testing, PT, and good laboratory practice checklist enhancements are necessary to promote accurate testing and information for consumers. Many of the changes proposed in this rule making are to include standards that are common for environmental labs which are similar to certified labs that test cannabis in Washington and are necessary to promote consistency, accuracy, and the proper information provided to consumers at retail.
Though these proposed rule changes will mean increased costs for businesses in the marijuana industry, these costs are justifiable. Rule changes are needed to protect consumer safety and convey accurate information to consumers through ensuring laboratories employ appropriate testing methodologies and achieve accurate testing results for marijuana. Creating PT requirements to achieve and maintain certification and parameters for laboratories will promote accuracy and accountability in marijuana testing by certified laboratories.
Describe How Small Businesses Were Involved in the Development of the Proposed Rule: WSLCB staff held several meetings with industry members, certified labs, WSLCB's certifying and auditing vendor, and other state agencies to inform the proposed rule changes in this CR-102 and to gather information relating to costs and effectiveness of potential rule changes. WSLCB staff collected comments both in writing and verbally from industry members as part of the rule-making process and informal work group meetings. Many of the changes included in this rule making are directly in response to requests from certified labs and the cannabis industry, as well as recommendations from partner science agencies. Additionally, the Cannabis Alliance in conjunction with the Washington Cannabis Laboratory Association conducted a survey of marijuana licensees at each level of the cannabis market which it shared with WSLCB to assist in the development of this SBEIS. WSLCB will continue to receive and assess comments as part of the formal comment process as this rule making progresses.
Identify the Estimated Number of Jobs That Will Be Created or Lost as the Result of Compliance with the Proposed Rule Changes: It is possible that these proposed rule changes could increase jobs in laboratories as additional tests would be required, which may create a need to hire additional staff. It is unclear whether the proposed changes will cause job losses as increased costs may be offset by [being] passing along to the consumer at retail.
A copy of the statement may be obtained by contacting Joanna Eide, Policy and Rules Coordinator, 3000 Pacific Avenue S.E., Olympia, WA 98504, phone (360) 664-1622, fax (360) 664-9689, e-mail Joanna.Eide@lcb.wa.gov.
A cost-benefit analysis is not required under RCW 34.05.328. A cost-benefit analysis was not required under RCW 34.05.328 because the proposed new rule does not qualify as a significant legislative rule or other rule requiring a cost-benefit analysis under RCW 34.05328(5) [34.05.328(5)].
December 7, 2016
Jane Rushford
Chair
NEW SECTION
WAC 314-55-0995 Laboratory certification and accreditation requirements.
The following requirements apply to third-party labs seeking certification by the WSLCB or its designee to do quality assurance testing on marijuana and marijuana products in Washington state, and for certified third-party laboratories (certified labs) to remain certified by the WSLCB. The requirements provided in this section are continuing requirements, and must be adhered to and maintained for a third-party lab to remain certified. The WSLCB may summarily suspend a lab's certification if a certified lab is found out of compliance with the requirements of this chapter.
(1) A third-party laboratory must be certified by the WSLCB or their vendor as meeting the WSLCB's accreditation and other requirements prior to conducting quality assurance tests required under this chapter. Certified labs must conspicuously display the certification letter received by the WSLCB upon certification at the lab's premises in a conspicuous location where a customer may observe it unobstructed in plain sight.
(2) A person with financial interest in a certified lab may not have direct or indirect financial interest in a licensed marijuana producer or processor for whom they are conducting required quality assurance tests. A person with direct or indirect financial interest in a certified lab must disclose to the WSLCB by affidavit any direct or indirect financial interest in a licensed marijuana producer or processor.
(3) The following provisions are conditions of certification for third-party testing labs. Failure to adhere to the below requirements may result in the suspension or revocation of certification.
(a) Each lab must employ a scientific director responsible to ensure the achievement and maintenance of quality standards of practice. The scientific director must possess the following minimum qualifications:
(i) A doctorate in the chemical or microbiological sciences from a college or university accredited by a national or regional certifying authority with a minimum of two years' post-degree laboratory experience;
(ii) A master's degree in the chemical or microbiological sciences from a college or university accredited by a national or regional certifying authority with a minimum of four years' of post-degree laboratory experience; or
(iii) A bachelor's degree in the chemical or microbiological sciences from a college or university accredited by a national or regional certifying authority with a minimum of six years of post-education laboratory experience.
(b) Certified labs must follow the analytical requirements most current version of the Cannabis Inflorescence and Leaf Monograph published by the American Herbal Pharmacopoeia or notify the WSLCB or its designee what alternative scientifically valid testing methodology the lab is following for each quality assurance test. Third-party validation by the WSLCB or its designee is required for any monograph or analytical method followed by a certified lab to ensure the methodology produces scientifically accurate results prior to use of alternative testing methods to conduct required quality assurance tests.
(c) The WSLCB may require third-party validation and ongoing monitoring of a certified lab's basic proficiency to correctly execute the analytical methodologies employed by the certified lab. The WSLCB may contract with a vendor to conduct the validation and ongoing monitoring described in this subsection. The certified lab must pay all vendor fees for validation and ongoing monitoring directly to the WSLCB's vendor.
(4) Certified labs must allow the WSLCB or the WSLCB's vendor to conduct physical visits and inspect related laboratory equipment, testing and other related records during normal business hours without advance notice.
(5) Labs must adopt and follow minimum good lab practices (GLPs) as provided in WAC 314-55-103, and maintain internal standard operating procedures (SOPs), and a quality control/quality assurance (QC/QA) program as specified by the WSLCB. The WSLCB or authorized third-party organization (WSLCB's designee) may conduct audits of a lab's GLPs, SOPs, QC/QA, and inspect all other related records.
(6) The WSLCB or its designee will take immediate disciplinary action against any certified lab that fails to comply with the provisions of this chapter or falsifies records related to this section including, without limitation, revoking the certification of the certified lab.
AMENDATORY SECTION (Amending WSR 16-11-110, filed 5/18/16, effective 6/18/16)
WAC 314-55-101 Quality assurance sampling protocols.
(1)(((a))) To ensure ((that)) quality assurance samples submitted to certified third-party ((labs)) laboratories (certified labs) are representative from the lot or batch from which they were sampled as required in RCW 69.50.348, licensed producers, licensed processors, certified ((third-party laboratories)) labs, and their employees must adhere to the ((following)) minimum sampling protocols as provided in this section.
(((b))) (2) Sampling protocols for all marijuana product lots and batches:
(a) Samples must be deducted in a way that is most representative of the lot or batch and maintains the structure of the marijuana sample. Licensees, certified ((third-party laboratories)) labs, and their employees may not adulterate or change in any way the representative sample from a lot or batch before submitting the sample to certified ((third-party laboratories)) labs. This includes adulterating or changing the sample in any way as to inflate the level of potency, or to hide any microbiological contaminants from the required microbiological screening such as, but not limited to:
(i) Adulterating the sample with kief, concentrates, or other extracts;
(ii) Treating a sample with solvents to hide the microbial count of the lot or batch from which it was deducted. This ((is not meant to be construed as prohibiting)) subsection does not prohibit the treatment of failed lots or batches with methods approved by the WSLCB; ((and)) or
(iii) Pregrinding a flower lot sample.
(((2) Sampling protocols for all marijuana product lots and batches: The deduction of all quality assurance samples must adhere to the following sampling protocols:
(a))) (b) All samples must be taken in a sanitary environment using sanitary practices and ensure facilities are constructed, kept, and maintained in a clean and sanitary condition in accordance with rules and as prescribed by the Washington state department of agriculture under chapters 16-165 and 16-167 WAC.
(((b))) (c) Persons ((taking)) collecting samples must wash their hands prior to ((deducting samples)) collecting a sample from a lot or batch, wear sterile gloves while preparing or deducting the lot or batch for ((sampling)) sample collection, and must use ((sanitary)) sterile utensils and storage devices when collecting samples.
(((c))) (d) Samples must be placed in a sterile ((plastic or glass)) container, and stored in a location that prevents the propagation of pathogens and other contaminants((. This includes low light levels, mild temperatures, and low humidity environments.
(d))), such as a secure, low-light, cool and dry location.
(e) The licensee ((shall)) must maintain the lot or batch from which the sample was deducted in a secure, low-light, cool, and dry location to prevent the marijuana from becoming contaminated or losing its efficacy.
(f) Each quality assurance sample must be clearly marked "quality assurance sample" and be labeled with the following information:
(i) The sixteen digit identification number generated by the traceability system;
(ii) The license number and name of the certified lab receiving the sample;
(iii) The license number and trade name of the licensee sending the sample;
(iv) The date the sample was collected; and
(v) The weight of the sample.
(3) Additional sampling protocols for flower lots:
(a) Licensees or certified ((third-party labs are required to deduct four)) labs must collect a minimum of three separate samples from each marijuana flower lot ((in order to ensure representativeness of the lot. The four)) up to five pounds. An additional sample must be collected for every five pound increment in lot weight, up to a maximum lot size of fifteen pounds. Flower lots that are more than five pounds, but less than ten pounds, require four samples. Flower lots more than ten pounds up to fifteen pounds require five samples. Licensees or certified labs may collect more samples than this minimum, but must not collect less. The samples must be of roughly equal weight((,)) not less than ((one)) two grams each((, and the cumulative weight of the four samples may not be more than the maximum allowed in WAC 314-55-102)).
(b) The ((four separate)) samples must be taken from different ((quadrants)) sections of the flower lot. A ((quadrant)) section is the division of a lot into ((four)) equal parts((. This may be done visually or physically, but)) in the same number as the number of samples to be collected. Dividing a lot into sections prior to collecting samples must be done in a manner that ensures the samples ((were deducted)) are collected from ((four)) evenly distributed areas of the flower lot and may be done visually or physically.
(c) The ((four separate samples may be placed together in a)) samples must be packaged in separate containers ((that conforms to)) conforming to the packaging and labeling requirements in subsection (2) of this section for storage and transfer to a certified ((third-party)) lab.
(4) Certified labs may retrieve samples from a marijuana licensee's licensed premises and transport the samples directly to the lab. Certified labs may also return any unused portion of the samples.
(5) Certified ((third-party laboratories)) labs may reject or fail a sample if ((they)) the lab has reason to believe the sample was not collected in the manner required by this section, ((has been)) adulterated in any way, contaminated with known or unknown solvents, or ((was)) manipulated in a ((way)) manner that violates the sampling protocols, limit tests, or action levels.
(((5))) (6) The WSLCB or its designee will take immediate disciplinary action against any licensee or certified ((third-party lab which)) lab that fails to comply with the provisions of this section or falsifies records related to this section including, without limitation, revoking the license ((or certificate of)) the licensed producer or processor, or certification of the certified ((third-party)) lab.
AMENDATORY SECTION (Amending WSR 16-11-110, filed 5/18/16, effective 6/18/16)
WAC 314-55-102 Quality assurance testing.
(((1))) A third-party testing lab must be certified by the WSLCB or ((their)) the WSLCB's vendor as meeting the WSLCB's accreditation and other requirements prior to conducting ((required)) quality assurance tests((. Certified labs will receive a certification letter from the WSLCB and must conspicuously display this letter in the lab in plain sight of the customers. The WSLCB can summarily suspend a lab's certification if a lab is found out of compliance with the requirements of this chapter.
(2) A person with financial interest in a certified third-party testing lab may not have direct or indirect financial interest in a licensed marijuana producer or processor for whom they are conducting required quality assurance tests. A person with direct or indirect financial interest in a certified third-party testing lab must disclose to the WSLCB by affidavit any direct or indirect financial interest in a licensed marijuana producer or processor.
(3) As a condition of certification, each lab must employ a scientific director responsible to ensure the achievement and maintenance of quality standards of practice. The scientific director shall meet the following minimum qualifications:
(a) Has earned, from a college or university accredited by a national or regional certifying authority a doctorate in the chemical or biological sciences and a minimum of two years' post-degree laboratory experience; or
(b) Has earned a master's degree in the chemical or biological sciences and has a minimum of four years' of post-degree laboratory experience; or
(c) Has earned a bachelor's degree in the chemical or biological sciences and has a minimum of six years of post-education laboratory experience.
(4) As a condition of certification, labs must follow the most current version of the Cannabis Inflorescence and Leaf monograph published by the American Herbal Pharmacopoeia or notify the WSLCB what alternative scientifically valid testing methodology the lab is following for each quality assurance test. The WSLCB may require third-party validation of any monograph or analytical method followed by the lab to ensure the methodology produces scientifically accurate results prior to them using those standards when conducting required quality assurance tests.
(5) As a condition of certification, the WSLCB may require third-party validation and ongoing monitoring of a lab's basic proficiency to correctly execute the analytical methodologies employed by the lab. The WSLCB may contract with a vendor to conduct the validation and ongoing monitoring described in this subsection. The lab shall pay all vendor fees for validation and ongoing monitoring directly to the vendor.
(6) The lab must allow the WSLCB or their vendor to conduct physical visits and inspect related laboratory equipment, testing and other related records during normal business hours without advance notice.
(7) Labs must adopt and follow minimum good lab practices (GLPs), and maintain internal standard operating procedures (SOPs), and a quality control/quality assurance (QC/QA) program as specified by the WSLCB. The WSLCB or authorized third-party organization can conduct audits of a lab's GLPs, SOPs, QC/QA, and inspect all other related records.
(8) The WSLCB or its designee will take immediate disciplinary action against any certified third-party lab which fails to comply with the provisions of this chapter or falsifies records related to this section including, without limitation, revoking the certificate of the certified third-party lab.
(9) The general body of required quality assurance tests for marijuana flowers and infused products may include moisture content, potency analysis, foreign matter inspection, microbiological screening, pesticide and other chemical residue and metals screening, and residual solvents levels.
(10) Table of required quality assurance tests defined in the most current version of the Cannabis Inflorescence and Leaf monograph published by the American Herbal Pharmacopoeia.
(a))) required under this section.
(1) Quality assurance fields of testing. Certified labs must be certified to the following fields of testing by the WSLCB or its designee and must adhere to the guidelines for each quality assurance field of testing listed below. Labs may become certified by the WSLCB or its designee to test for heavy metal and pesticide residue screening, but must become certified in those fields of testing prior to conducting any testing or screening.
(a) Potency analysis.
(i) Certified labs must test and report the following cannabinoids to the WSLCB when testing for potency:
(A) THCA;
(B) THC;
(C) Total THC;
(D) CBDA;
(E) CBD; and
(F) Total CBD.
(ii) Calculating total THC and total CBD.
(A) Total THC must be calculated as follows, where 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).
(B) Total CBD must be calculated as follows, where M is the mass or mass fraction of CBD and CBDA: M total CBD = M CBD + (0.877 x M CBDA).
(iii) Regardless of analytical equipment or methodology, certified labs must accurately measure and report the acidic (THCA and CBDA) and neutral (THC and CBD) forms of the cannabinoids.
(b) Potency analysis for flower lots.
(i) Certified labs must test and report the individual results and averages for the number of required flower lot samples as described in WAC 314-55-101(3) for the following required cannabinoids:
(A) THCA;
(B) THC;
(C) Total THC;
(D) CBDA;
(E) CBD; and
(F) Total CBD.
(ii) Calculating total THC and total CBD.
(A) Total THC must be calculated as follows, where 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).
(B) Total CBD must be calculated as follows, where M is the mass or mass fraction of CBD and CBDA: M total CBD = M CBD + (0.877 x M CBDA).
(c) Certified labs may combine in equal parts multiple samples from the same flower lot for the purposes of the following tests after the individual samples described in WAC 314-55-101(3) have been tested for potency analysis.
(i) Moisture analysis. The sample and related lot or batch fails quality assurance testing for moisture analysis if the results exceed the following limits:
(A) Water activity rate of more than 0.65 aw; and
(B) Moisture content more than fifteen percent.
(ii) Foreign matter screening. The sample and related lot or batch fail quality assurance testing for foreign matter screening if the results exceed the following limits:
(A) Five percent of stems 3mm or more in diameter; and
(B) Two percent of seeds or other foreign matter.
(iii) Microbiological screening. The sample and related lot or batch fail quality assurance testing for microbiological screening if the results exceed the following limits:
(iv) Mycotoxin screening. The sample and related lot or batch fail quality assurance testing for mycotoxin screening if the results exceed the following limits:
(A) Total of Aflatoxin B1, B2, G1, G2: 20 μg/kg of substance; and
(B) Ochratoxin A: 20 μg/kg of substance.
(d) Residual solvent screening. Except as otherwise provided in this subsection, a sample and related lot or batch fail quality assurance testing for residual solvents if the results exceed the limits provided in the table below. Residual solvent results of more than 5,000 ppm for class three solvents, 50 ppm for class two solvents, and 2 ppm for class one solvents as defined in United States Pharmacopoeia, USP 30 Chemical Tests / <467> - Residual Solvents (USP <467>) not listed in the table below fail quality assurance testing. When residual solvent screening is required, certified labs must test for the solvents listed in the table below at a minimum.
(2) Quality assurance testing required. The following quality assurance tests are the minimum required tests for each of the following marijuana products, respectively. Licensees and certified labs may elect to do additional testing if desired.
(a) General quality assurance testing requirements for certified labs.
(i) Certified labs must record an acknowledgment of the receipt of samples from producers or processors in the WSLCB seed to sale traceability system. Certified labs must also verify if any unused portion of the sample was destroyed or returned to the licensee after the completion of required testing.
(ii) Certified labs must report quality assurance test results directly to the WSLCB traceability system when quality assurance tests for the field of testing are required within twenty-four hours of completion.
(iii) Certified labs must fail a sample if the results for any limit test are above allowable levels regardless of whether the limit test is required in the testing tables in this section.
(b) Marijuana flower lots and other material lots. Marijuana flower lots or other material lots require the following quality assurance tests:
(((b))) (c) Intermediate products. Intermediate products must meet the following requirements related to quality assurance testing:
(i) All intermediate products must be homogenized prior to quality assurance testing;
(ii) ((A batch)) For the purposes of this section, a batch is defined as a single run through the extraction or infusion process;
(iii) A batch of marijuana mix may not exceed ((five)) fifteen pounds and must be chopped or ground so no particles are greater than 3 mm; and
(iv) All batches of intermediate products require the following quality assurance tests:
(((c))) (d) End products. All marijuana, marijuana-infused products, marijuana concentrates, marijuana mix packaged, and marijuana mix infused sold from a processor to a retailer require the following quality assurance tests:
(((d))) (e) End products consisting of only one intermediate product that has not been changed in any way ((is)) are not subject to potency analysis.
(((11) Certified third-party labs may request additional sample material in excess of amounts listed in the table in subsection (10) of this section for the purposes of completing required quality assurance tests. Labs certified as meeting the WSLCB's accreditation requirements may retrieve samples from a marijuana licensee's licensed premises and transport the samples directly to the lab and return any unused portion of the samples.
(12) Labs certified as meeting the WSLCB's accreditation requirements are not limited in the amount of usable marijuana and marijuana products they may have on their premises at any given time, but they must have records to prove all marijuana and marijuana-infused products only for the testing purposes described in WAC 314-55-102.
(13) At the discretion of the WSLCB, a producer or processor must provide an employee of the WSLCB or their designee samples in the amount listed in subsection (10) of this section or samples of the growing medium, soil amendments, fertilizers, crop production aids, pesticides, or water for random compliance checks. Samples may be screened for pesticides and chemical residues, unsafe levels of metals, and used for other quality assurance tests deemed necessary by the WSLCB. All costs of this testing will be borne by the producer or processor.
(14))) (3) No lot of usable flower, batch of marijuana concentrate, or batch of marijuana-infused product may be sold or transported until the completion ((of all required)) and successful passage of quality assurance testing((.)) as required in this section, except:
(a) Business entities with multiple locations licensed under the same UBI number may transfer marijuana products between the licensed locations under ((their)) the same UBI number prior to quality assurance testing((.
(15) Any usable marijuana or marijuana-infused product that passed the required quality assurance tests may be labeled as "Class A." Only "Class A" usable marijuana or marijuana-infused product will be allowed to be sold.
(16))); and
(b) Licensees may wholesale and transfer batches or lots of flower and other material that will be extracted and marijuana mix and nonsolvent extracts for the purposes of further extraction prior to completing required quality assurance testing. Licensees may wholesale and transfer failed lots or batches to be extracted pursuant to subsection (5) of this section.
(4) Samples, lots, or batches that fail quality assurance testing.
(a) Upon approval ((of)) by the WSLCB, ((a lot that fails a quality assurance test and the associated trim, leaf and other usable material)) failed lots or batches may be used to create extracts ((using hydrocarbon or CO2 closed loop system)). After processing, the ((CO2 or hydrocarbon based)) extract must ((still)) pass all ((required)) quality assurance tests ((in WAC 314-55-102)) required in this section before it may be sold.
(((17))) (b) Retesting. At the request of the producer or processor, the WSLCB may authorize a retest to validate a failed test result on a case-by-case basis. All costs of the retest will be borne by the producer or the processor((.
(18) Labs must report all required quality assurance test results directly into the WSLCB's seed to sale traceability system within twenty-four hours of completion. Labs must also record in the seed to sale traceability system an acknowledgment of the receipt of samples from producers or processors and verify if any unused portion of the sample was destroyed or returned to the licensee.)) requesting the retest.
(c) Lot remediation. Producers and processors may remediate failed harvests, lots, or batches so long as the remediation method does not impart any toxic or deleterious substance to the usable marijuana, marijuana concentrates, or marijuana-infused product. Remediation solvents or methods used on the marijuana product must be disclosed to a licensed processor the producer or producer/processor transfers the products to; a licensed retailer carrying marijuana products derived from the remediated harvest, lot, or batch; or consumer upon request. The entire harvest, lot, or batch the failed sample(s) were deducted from must be remediated using the same remediation technique. No remediated harvest, lots or batches may be sold or transported until the completion and successful passage of quality assurance testing as required in this section.
(5) Referencing. Certified labs may reference fields of testing to other certified labs by subcontracting fields of testing identified in this section. Labs must record all referencing to other labs on a chain-of-custody manifest that includes, but is not limited to, the following information: Lab name, certification number, transfer date, address, contact information, delivery personnel, sample ID numbers, field of testing, receiving personnel.
(6) Certified labs are not limited in the amount of usable marijuana and marijuana products they may have on their premises at any given time, but they must have records proving all marijuana and marijuana-infused products in the certified lab's possession are held only for the testing purposes described in this section.
(7) Upon the request of the WSLCB or its designee, a licensee or a certified lab must provide an employee of the WSLCB or their designee samples of marijuana or marijuana products or samples of the growing medium, soil amendments, fertilizers, crop production aids, pesticides, or water for random compliance checks. Samples may be screened for pesticides and chemical residues, unsafe levels of heavy metals, and used for other quality assurance tests deemed necessary by the WSLCB.
AMENDATORY SECTION (Amending WSR 16-11-110, filed 5/18/16, effective 6/18/16)
WAC 314-55-103 Good laboratory practice checklist.
A third-party testing lab must be certified by the WSLCB or its vendor as meeting the WSLCB's accreditation and other requirements prior to conducting required quality assurance tests. The following checklist will be used by the WSLCB or its vendor to certify third-party testing labs:
NEW SECTION
WAC 314-55-1025 Proficiency testing.
(1) For the purposes of this section, the following definitions apply:
(a) "Field of testing" means the categories of subject matter the laboratory tests, such as pesticide, microbial, potency, residual solvent, heavy metal, mycotoxin, foreign matter, and moisture content detection.
(b) "Proficiency testing (PT)" means the analysis of samples by a laboratory obtained from providers where the composition of the sample is unknown to the laboratory performing the analysis and the results of the analysis are used in part to evaluate the laboratory's ability to produce precise and accurate results.
(c) "Proficiency testing (PT) program" means an operation offered by a provider to detect a laboratory's ability to produce valid results for a given field of testing.
(d) "Provider" means a third-party company, organization, or entity not associated with certified laboratories or a laboratory seeking certification that operates an approved PT program and provides samples for use in PT testing.
(e) "Vendor" means an organization(s) approved by the WSLCB to certify laboratories for marijuana testing, approve PT programs, and perform on-site assessments of laboratories.
(2) The WSLCB or its vendor determines the sufficiency of PTs and maintains a list of approved PT programs. Laboratories may request authorization to conduct PT through other PT programs but must obtain approval for the PT program from WSLCB or WSLCB's vendor prior to conducting PT. The WSLCB may add the newly approved PT program to the list of approved PT programs as appropriate.
(3) As a condition of certification, laboratories must participate in PT and achieve a passing score for each field of testing for which the lab will be or is certified.
(4) A laboratory must successfully complete a minimum of one round of PT for each field of testing the lab seeks to be certified for and provide proof of the successful PT results prior to initial certification.
(5)(a) A certified laboratory must participate in a minimum of two rounds of PT per year for each field of testing to maintain its certification.
(b) To maintain certification, the laboratory must achieve a passing score, on an ongoing basis, in a minimum of two out of three successive rounds of PT. At least one of the scores must be from a round of PT that occurs within six months prior to the laboratory's certification renewal date.
(6) If the laboratory fails to achieve a passing score on at least eighty percent of the analytes in any proficiency test, the test is considered a failure. If the PT provider provides a pass/fail on a per analyte basis but not on the overall round of PT the lab participates in, the pass/fail evaluation for each analyte will be used to evaluate whether the lab passed eighty percent of the analytes. If the PT provider does not provide individual acceptance criteria for each analyte, the following criteria will be applied to determine whether the lab achieves a passing score for the round of PT:
(a) +/- 30% recovery from the reference value for residual solvent testing; or
(b) +/- 3 z or 3 standard deviations from the reference value for all other fields of testing.
(7) If a laboratory fails a round of PT or reports a false negative on a micro PT, the laboratory must investigate the root cause of the laboratory's performance and establish a corrective action report for each unsatisfactory analytical result. The corrective action report must be kept and maintained by the laboratory for a period of three years, available for review during an on-site assessment or inspection, and provided to the WSLCB or WSLCB's vendor upon request.
(8) Laboratories are responsible for obtaining PT samples from vendors approved by WSLCB or WSLCB's vendor. Laboratories are responsible for all costs associated with obtaining PT samples and rounds of PT.
(9) The laboratory must manage, analyze and report all PT samples in the same manner as customer samples including, but not limited to, adhering to the same sample tracking, sample preparation, analysis methods, standard operating procedures, calibrations, quality control, and acceptance criteria used in testing customer samples.
(10) The laboratory must authorize the PT provider to release all results used for certification and/or remediation of failed studies to WSLCB or WSLCB's vendor.
(11) The WSLCB may require the laboratory to submit raw data and all photographs of plated materials along with the report of analysis of PT samples. The laboratory must keep and maintain all raw data and all photographs of plated materials from PT for a period of three years.
(12) The WSLCB may waive proficiency tests for certain fields of testing if PT samples or PT programs are not readily available or for other valid reasons as determined by WSLCB.
(13)(a) The WSLCB will suspend a laboratory's certification if the laboratory fails to maintain a passing score on an ongoing basis in two out of three successive PT studies. The WSLCB may reinstate a laboratory's suspended certification if the laboratory successfully analyzes PT samples from a WSLCB or WSLCB's vendor approved PT provider, so long as the supplemental PT studies are performed at least fifteen days apart from the analysis date of one PT study to the analysis date of another PT study.
(b) The WSLCB will suspend a laboratory's certification if the laboratory fails two consecutive rounds of PT. WSLCB may reinstate a laboratory's suspended certification once the laboratory conducts an investigation, provides the WSLCB a deficiency report identifying the root cause of the failed PT, and successfully analyzes PT samples from a WSLCB or WSLCB's vendor approved PT provider. The supplemental PT studies must be performed at least fifteen days apart from the analysis date of one PT study to the analysis date of another PT study.
(14) If a laboratory fails to remediate and have its certification reinstated under subsection (13)(a) or (b) of this section within six months of the suspension, the laboratory must reapply for certification as if the laboratory was never certified previously.
(15) A laboratory that has its certification suspended or revoked under this section may request an administrative hearing to contest the suspension as provided in chapter 34.05 RCW.
NEW SECTION
WAC 314-55-1035 Laboratory certification—Suspension and revocation.
(1) The board may summarily suspend or revoke the certification of any lab certified under WAC 314-55-0995 for any of the following reasons:
(a) The laboratory owner or science director violates any of the requirements of chapter 314-55 WAC relating to the operations of the laboratory.
(b) The laboratory owner or science director aids, abets, or permits the violation of any provision of chapters 314-55 WAC, 69.50 RCW, 69.51A RCW, or Title 9 or 9A RCW related to the operations of the laboratory, or the laboratory owner or science director permits laboratory staff to do so.
(c) Evidence the certificate holder or owner made false statements in any material regard:
(i) On the application for certification;
(ii) In submissions to the board relating to receiving or maintaining certification; or
(iii) Regarding any testing performed or results provided to WSLCB or the marijuana licensee by the certificate holder or owner pursuant to WAC 314-55-102.
(d) The laboratory owner or science director is convicted of any crime substantially related to the qualifications or duties of that owner and related to the functions of the laboratory, including a conviction for falsifying any report of or that relates to a laboratory analysis. For purposes of this subsection, a "conviction" means a plea or finding of guilt regardless of whether the imposition of sentence is deferred or the penalty is suspended.
(e) The laboratory submits proficiency test sample results generated by another laboratory as its own.
(f) The laboratory staff denies entry to any employee of the WSLCB or WSLCB's vendor during normal business hours for an on-site assessment or inspection, as required by WAC 314-55-0995, 314-55-102, 314-55-1025, or 314-55-103.
(2)(a) The following violations are subject to the penalties as provided in (b) of this subsection:
(i) The laboratory fails to submit an acceptable corrective action report in response to a deficiency report, and failure to implement corrective action related to any deficiencies found during a laboratory assessment.
(ii) The laboratory fails to report proficiency testing results pursuant to WAC 314-55-1025.
(iii) The laboratory fails to remit certification fees within the time limit established by a certifying authority.
(iv) The laboratory fails to meet recordkeeping requirements as required by chapter 314-55 WAC unless the failure to maintain records is substantial enough to warrant a suspension or revocation under subsection (1) of this section.
(b) The penalties for the violations in (a) of this subsection are as follows:
(i) First violation: Ten-day suspension of the lab's certification or until the lab corrects the violation leading to the suspension, whichever is longer.
(ii) Second violation within a three-year period: Thirty-day suspension of laboratory certification or until the laboratory corrects the violation leading to the suspension, whichever is longer.
(iii) Third violation within a three-year period: Revocation of the lab's certification.
(3) A certified lab may also be subject to a suspension of certification related to proficiency testing requirements under WAC 314-55-1025.
(4) A laboratory that has its certification suspended or revoked under this section may request an administrative hearing to contest the suspension or revocation as provided in chapter 34.05 RCW.
NEW SECTION
WAC 314-55-108 Pesticide action levels.
(1) Only pesticides allowed under WAC 314-55-084 may be used in the production of marijuana, and they must be registered by the Washington state department of agriculture (WSDA) under chapter 15.58 RCW.
(2) Pursuant to WAC 314-55-102, if the WSLCB, WSDA, other designee of the WSLCB, or certified lab identifies a pesticide that is not allowed under subsection (1) of this section and is above the action levels provided in subsection (3) of this section, that lot or batch from which the sample was deducted has failed quality assurance testing and may be subject to a recall as provided in WAC 314-55-225.
(3) The action levels for pesticides are provided in the table below. The action level for all other pesticides that are not allowed under subsection (1) of this section or listed in the table below is 0.1 ppm.
(4) Except as otherwise provided in this section, licensed marijuana producer or processor that provided a sample that fails quality assurance testing must dispose of the entire lot or batch from which the sample was taken as provided by marijuana waste disposal requirements in WAC 314-55-097 and document the disposal of the sample pursuant to traceability requirements in WAC 314-55-083(4) and recordkeeping requirements in WAC 314-55-087.
(5) Except as otherwise provided in this section, a licensed marijuana producer or processor which provided a sample that fails quality assurance testing must dispose of the entire lot or batch from which the sample was taken as provided by marijuana waste disposal requirements in WAC 314-55-097 and document the disposal of the sample pursuant to traceability requirements in WAC 314-55-083(4) and recordkeeping requirements in WAC 314-55-087.
(6) Pursuant to WAC 314-55-102, at the request of the producer or processor, the WSLCB may authorize a retest to validate a failed test result on a case-by-case basis. All costs of the retest will be borne by the producer or the processor requesting the retest.
(7) Producers and processors may remediate failed harvests, lots, or batches so long as the remediation method does not impart any toxic or deleterious substance to the usable marijuana, marijuana concentrates, or marijuana-infused product. Remediation solvents or methods used on the marijuana product must be disclosed to a licensed retailer or consumer upon request. The entire harvest, lot, or batch the failed sample(s) were deducted from must be remediated using the same remediation technique. No remediated harvest, lots or batches may be sold or transported until the completion and successful passage of quality assurance testing as required in this section and WAC 314-55-102.
(8) Pursuant to WAC 314-55-102, upon request a marijuana licensee must disclose and make available all quality assurance tests and retest results for the lot or batch of usable marijuana, marijuana concentrates, or marijuana-infused products to the marijuana licensee or retail customer who is considering purchasing the usable marijuana, marijuana concentrates, or marijuana-infused products.
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