(1)
Certified laboratory quality control testing. To become certified,
a third-party lab must meet the board's certification and accreditation
requirements as described in WAC
314-55-0995 and this chapter before conducting
quality control tests required under this section. Cannabis licensees must use
a laboratory certified by the board (certified laboratory) to conduct quality
control testing required under this chapter. Prior to becoming certified,
laboratories must be accredited by the WSDA as specified in chapter
16-309 WAC.
(a) Licensees must use certified laboratories
to conduct testing on cannabis and cannabis products in the following required
fields of testing:
(i) Water
activity;
(ii) Cannabinoid
concentration analysis;
(iii)
Foreign matter inspection;
(iv)
Microbiological screening;
(v)
Mycotoxin screening;
(vi) Pesticide
screening; and
(vii) Residual
solvent screening.
(b)
Certified labs may be certified for heavy metal testing. Certified labs must
comply with the guidelines for each quality control field of testing described
in this chapter if they offer that testing service.
(c) Certified labs may reference samples for
mycotoxin, heavy metal, or pesticide testing by subcontracting for those fields
of testing.
(2)
General product quality control testing requirements for certified
labs.
(a) Certified labs must record an
acknowledgment of the receipt of samples from producers or processors.
Certified labs must also verify if any unused portion of the sample is
destroyed after the completion of required testing.
(b) Certified labs must report quality
control test results directly to the board in the required format.
(c) Product must not be converted,
transferred, or sold by the licensee until the required tests are reported to
the board and the licensee.
(d)
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 chapter.
(e)
Certified labs must test samples on an "as is" or "as received"
basis.
(f) For the purposes of this
section, limits have been written to the number of significant digits that
certified laboratories are expected to use when reporting to the board and on
associated certificates of analysis.
(3)
Quality control analysis and
screening. The following analysis and screening are only required for
samples that have not been previously tested, or that have failed quality
control testing.
(a)
Cannabinoid
concentration analysis.
(i) A
cannabinoid concentration analysis is required to determine the concentration
of cannabinoid compounds present in cannabis and cannabis products. The results
of the cannabinoid concentration analysis must be reported to the board in the
state's traceability system in the required format. The cannabinoid
concentration analysis must include testing for at least the following
cannabinoids:
(A)
|
Cannabinoid
|
Lower Limit of Quantitation
(mg/g)
|
CAS #
|
|
CBD
|
1.0
|
13956-29-1
|
|
CBDA
|
1.0
|
1244-58-2
|
|
[DELTA]9-THC
|
1.0
|
1972-08-3
|
|
[DELTA]9-THCA
|
1.0
|
23978-85-0
|
(B)
Any THC compound that is labeled, advertised, or marketed as part of the
product;
(C) Total delta-9 THC;
(D) Total THC for
tetrahydrocannabinol compounds other than delta-9 THC;
(E) Total CBD.
(ii) Calculating total THC and total CBD.
(A) Total delta-9 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 × M delta-9 THCA).
(B) Total THC for tetrahydrocannabinol
compounds other than delta-9 that are present in an amount greater than 0.2
mg/g must be calculated as follows, where M is the mass or mass fraction of the
neutral (THC) or acidic form (THCA) of the tetrahydrocannabinol compound: M
total THC = M THC + [(molar mass of THC/molar mass of THCA) × M
THCA].
(C) 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 × 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)
Water activity
testing. The sample fails quality control testing for water activity if
the results exceed the following limits:
(i)
Water activity rate of more than 0.65 aw for useable
cannabis;
(ii) Water activity rate
of more than 0.85 aw for solid edible
products.
(c)
Foreign matter screening. The sample fails quality control testing
for foreign matter screening if the results exceed the following limits:
(i) Five percent of stems 3 mm or more in
diameter; or
(ii) Two percent of
seeds or other foreign matter; or
(iii) One insect fragment, one hair, or one
mammalian excreta in sample.
(d)
Microbiological screening.
The sample and the related population fails quality control testing for
microbiological screening if the results exceed the following limits:
|
Unprocessed Plant
Material
|
Colony Forming Unit per Gram
(CFU/g)
|
|
Bile Tolerant Gram
Negative bacteria (BTGN)
|
1.0 * 104
|
|
Shiga toxin-producing Escherichia coli
(STEC)
|
[LESS THAN]1
|
|
Salmonella spp.
|
[LESS THAN]1
|
|
Processed Plant
Material
|
Colony Forming Unit per Gram
(CFU/g)
|
|
Bile Tolerant Gram
Negative bacteria (BTGN)
|
1.0 * 103
|
|
Shiga toxin-producing Escherichia coli
(STEC)
|
[LESS THAN]1
|
|
Salmonella spp.
|
[LESS THAN]1
|
(e)
Mycotoxin screening. The sample and the related population fails
quality control testing if the results exceed the following limits:
|
Mycotoxin
|
µg/kg
|
CAS #
|
|
Aflatoxins (Sum of Isomers)
|
20.
|
|
|
* Aflatoxin B1
|
|
1162-65-8
|
|
* Aflatoxin B2
|
|
7220-81-7
|
|
* Aflatoxin G1
|
|
1165-39-5
|
|
* Aflatoxin G2
|
|
7241-98-7
|
|
Ochratoxin A
|
20.
|
303-47-9
|
(f)
Residual solvent screening. Except as otherwise provided in this
subsection, a sample and the related population fails quality control 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 any 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 control testing. When residual solvent screening is
required, certified labs must test for the solvents listed in the table below
at a minimum.
|
Solvent
|
µg/g
|
ppm
(simplified)
|
CAS #
|
|
Acetone
|
5.0 * 103
|
5000
|
67-64-1
|
|
Benzene
|
2.0
|
2
|
71-43-2
|
|
Butanes (Sum of Isomers)
|
5.0 * 103
|
5000
|
|
|
* n-butane
|
|
|
106-97-8
|
|
* 2-methylpropane
(isobutane)
|
|
|
75-28-5
|
|
Cyclohexane
|
3.9 * 103
|
3880
|
110-82-7
|
|
Chloroform
|
2.0
|
2
|
67-66-3
|
|
Dichloromethane
|
6.0 * 102
|
600
|
75-09-2
|
|
Ethanol
|
5.0 * 103
|
5000
|
64-17-5
|
|
Ethyl acetate
|
5.0 * 103
|
5000
|
141-78-6
|
|
Heptanes (Single Isomer)
|
5.0 * 103
|
5000
|
|
|
* n-heptane
|
|
|
142-82-5
|
|
Hexanes (Sum of Isomers)
|
2.9 * 102
|
290
|
|
|
* n-hexane
|
|
|
110-54-3
|
|
* 2-methylpentane
|
|
|
107-83-5
|
|
* 3-methylpentane
|
|
|
96-14-0
|
|
*
2,2-dimethylbutane
|
|
|
75-83-2
|
|
*
2,3-dimethylbutane
|
|
|
79-29-8
|
|
Isopropanol (2-propanol)
|
5.0 * 103
|
5000
|
67-63-0
|
|
Methanol
|
3.0 * 103
|
3000
|
67-56-1
|
|
Pentanes (Sum of Isomers)
|
5.0 * 103
|
5000
|
|
|
* n-pentane
|
|
|
109-66-0
|
|
* methylbutane
(isopentane)
|
|
|
78-78-4
|
|
* dimethylpropane
(neopentane)
|
|
|
463-82-1
|
|
Propane
|
5.0 * 103
|
5000
|
74-98-6
|
|
Toluene
|
8.9 * 102
|
890
|
108-88-3
|
|
Xylenes (Sum of Isomers)
|
2.2 * 103
|
2170
|
|
|
* 1,2-dimethylbenzene
(ortho-)
|
|
|
95-47-6
|
|
* 1,3-dimethylbenzene
(meta-)
|
|
|
108-38-3
|
|
* 1,4-dimethylbenzene
(para-)
|
|
|
106-42-3
|
(g)
Heavy metal screening. Heavy metal screening is required for all
DOH compliant product as described in chapter
246-70 WAC. Heavy metal screening
is optional for non-DOH compliant product; however, heavy metal limits provided
below apply to all products. Any product exceeding the provided limits is
subject to recall and destruction. The board may conduct random or
investigation driven heavy metal screening for compliance. A sample and related
quantity of product fail quality control testing for heavy metals if the
results exceed the limits provided in the table below.
|
Metal
|
µg/g
|
|
Arsenic
|
2.0
|
|
Cadmium
|
0.82
|
|
Lead
|
1.2
|
|
Mercury
|
0.40
|
(h)
Pesticide screening. For purposes of pesticide screening, a sample
and the related quantity of cannabis is considered to have passed if it meets
the standards described in WAC
314-55-108 and applicable department of
agriculture rules.
(4)
Required quality control tests. The following quality control
tests are required for each of the cannabis products described below. Licensees
and certified labs may opt to perform additional quality control tests on the
same sample.
(a)
Cannabis flower.
Cannabis flower requires the following quality control tests:
|
Product
|
Test(s)
Required
|
|
Cannabis flower
|
1. Water activity testing
2. Cannabinoid concentration analysis
3. Foreign matter inspection
4. Microbiological screening
5. Mycotoxin screening
6. Pesticide screening
|
(b) If
cannabis flower will be sold as useable flower, no further testing is
required.
(c)
Intermediate
products. Intermediate products must meet the following requirements
related to quality control testing:
(i) All
intermediate products must be homogenized prior to quality assurance
testing;
(ii) For the purposes of
this section, a batch is defined as a single run through the extraction or
infusion process;
(iii) Cannabis
mix must be chopped or ground so no particles are greater than 3 mm;
and
(iv) Intermediate products
require the following quality assurance tests:
|
Intermediate Product
Type
|
Tests
Required
|
|
Cannabis mix
|
1. Water activity testing
2. Cannabinoid concentration analysis
3. Foreign matter inspection
4. Microbiological screening
5. Mycotoxin screening
6. Pesticide screening
|
|
Concentrate or extract made with hydrocarbons
(solvent based made using n-butane, isobutane, propane, heptane, or other
solvents or gases approved by the board of at least 99% purity)
|
1. Cannabinoid concentration analysis
2. Mycotoxin screening
3. Residual solvent test
4. Pesticide screening
|
|
Concentrate or extract made with a CO2
extractor like hash oil
|
1. Cannabinoid concentration analysis
2. Mycotoxin screening
3. Residual solvent test
4. Pesticide screening
|
|
Concentrate or extract made with
ethanol
|
1. Cannabinoid concentration analysis
2. Mycotoxin screening
3. Residual solvent test
4. Pesticide screening
|
|
Concentrate or extract made with approved food grade
solvent
|
1. Cannabinoid concentration analysis
2. Microbiological screening
3. Mycotoxin screening
4. Residual solvent test
5. Pesticide screening
|
|
Concentrate or extract (nonsolvent) such as kief,
hash, rosin, or bubble hash
|
1. Cannabinoid concentration analysis
2. Microbiological screening
3. Mycotoxin screening
4. Pesticide screening
|
|
Infused cooking oil or fat in solid
form
|
1. Cannabinoid concentration analysis
2. Microbiological screening
3. Mycotoxin screening
4. Pesticide screening
|
(d)
End products. All cannabis,
cannabis-infused products, cannabis concentrates, cannabis mix packaged, and
cannabis mix infused sold from a processor to a retailer require the following
quality assurance tests:
|
End Product
Type
|
Tests
Required
|
|
Infused solid edible
|
1. Cannabinoid concentration analysis
2. Water activity testing
|
|
Infused liquid (like a soda or tonic)
|
1. Cannabinoid concentration analysis
|
|
Infused topical
|
1. Cannabinoid concentration analysis
|
|
Cannabis mix packaged (loose or
rolled)
|
1. Cannabinoid concentration analysis
|
|
Cannabis mix infused (loose or
rolled)
|
1. Cannabinoid concentration analysis
|
|
Concentrate or cannabis-infused product for
inhalation
|
1. Cannabinoid concentration analysis
|
(e)
End products consisting of only one intermediate product that has not been
changed in any way are not subject to cannabinoid concentration
analysis.
(5) Useable
flower, a batch of cannabis concentrate, or a batch of cannabis-infused product
may not be sold until the completion and successful passage of required quality
control testing, except:
(a) Licensees may
wholesale and transfer batches or quantities of cannabis flower and other
material that will be extracted, and cannabis mix and nonsolvent extracts, for
the purposes of further extraction prior to completing required quality control
testing.
(b) Business entities with
multiple locations licensed under the same UBI number may transfer cannabis
products between the licensed locations under the same UBI number prior to
quality control testing.
(c)
Licensees may wholesale and transfer failed batches or quantities of cannabis
flower to be extracted pursuant to subsection (6) of this section, unless
failed for tests that require immediate destruction.
(6)
Failed test samples.
(a) Upon approval by the board, failed
quantities of cannabis or batches may be used to create extracts. After
processing, the extract must pass all quality control tests required in this
section before it may be sold, unless failed for tests that require immediate
destruction.
(b) Retesting. A
producer or processor must request retesting. The board may authorize the
retest to validate a failed test result on a case-by-case basis. The producer
or the processor requesting the re-test must pay for the cost of all
retesting.
(c) Remediation.
Remediation is a process or technique applied to quantities of cannabis flower,
lots, or batches. Remediation may occur after the first failure, depending on
the failure, or if a retest process results in a second failure. Pesticide
failures may not be remediated.
(i) Producers
and processors may remediate failed cannabis flower, lots, or batches so long
as the remediation method does not impart any toxic or harmful substance to the
useable cannabis, cannabis concentrates, or cannabis-infused product.
Remediation solvents or methods used on the cannabis product must be disclosed
to:
(A) A licensed processor;
(B) The producer or producer/processor who
transfers the cannabis products;
(C) A licensed retailer carrying cannabis
products derived from the remediated cannabis flower, lot, or batch;
or
(D) The consumer upon
request.
(ii) The entire
quantity of cannabis from which the failed sample(s) were deducted must be
remediated.
(iii) No remediated
quantity of cannabis may be sold or transported until quality control testing
consistent with the requirements of this section is completed.
(iv) If a failed quantity of remediated
cannabis is not remediated or reprocessed in any way after a first failure, it
cannot be re-tested. Any subsequent certificates of analysis produced without
remediation or reprocessing of the failed quantity of cannabis will not
supersede the original compliance testing certificate of analysis.
(7)
Referencing. Certified laboratories may reference samples for
mycotoxins, heavy metals, and pesticides testing to other certified labs by
subcontracting for those fields of testing. Laboratories 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, and receiving personnel.
(8) Certified laboratories are not limited in
the amount of useable cannabis and cannabis products they may have on their
premises at any given time, but a certified laboratory must have records
proving all cannabis and cannabis-infused products in the certified lab's
possession are held only for the testing purposes described in this
chapter.
(9) A certificate of
analysis issued by a certified laboratory for any cannabis product subject to
the requirements of this chapter that has not already been transferred to a
retail location expires 12 calendar months after issuance.
(10) The board, or its designee, may request
that a licensee or a certified lab provide an employee of the board or their
designee samples of cannabis or cannabis products, or samples of the growing
medium, soil amendments, fertilizers, crop production aids, pesticides, or
water for random or investigatory compliance checks. Samples may be randomly
screened and used for other quality control tests deemed necessary by the
board.
(11) All cannabis products
produced, processed, distributed, or sold after the effective date of these
rules, must comply with these rules and this chapter; however, postharvest
products in the possession of or being processed by a licensee that do not
comply with these rules as of their effective date may be sold, distributed, or
both within a reasonable period of time, determined by the board.
Notes
Wash. Admin. Code §
314-55-102
Amended by
WSR
14-07-116, filed 3/19/14, effective
4/19/2014
Amended by
WSR
15-11-107, Filed 5/20/2015, effective
6/20/2015
Amended by
WSR
16-11-110, Filed 5/18/2016, effective
6/18/2016
Amended by
WSR
17-12-032, Filed 5/31/2017, effective
8/31/2017
Amended by
WSR
22-06-097, Filed 3/2/2022, effective
4/2/2022
Amended by
WSR
22-14-111, Filed 7/6/2022, effective
8/6/2022
Amended by
WSR
24-21-051, Filed 10/9/2024, effective
1/7/2025
Statutory Authority:
RCW
69.50.325,
69.50.331,
69.50.342,
69.50.345. WSR 13-21-104, §
314-55-102, filed 10/21/13, effective 11/21/13. WSR 13-21-003, §
314-55-102, filed 10/3/2013, effective
11/3/2013
