(1)
Lab certification and accreditation for 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.
(a) Certified labs must be certified
to conduct the following fields of testing:
(i) Water activity;
(ii) Potency 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 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
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)
Potency
analysis.
(i) Certified labs must test
and report the following cannabinoids to the board when testing for potency:
(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)
Total THC;
(C) 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 × 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 × 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)
|
<1
|
|
Salmonella spp.
|
<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)
|
<1
|
|
Salmonella spp.
|
<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 Pharmaco poeia 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. Potency 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. Potency 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. Potency analysis
2. Mycotoxin screening
3. Residual solvent test
4. Pesticide screening
|
|
Concentrate or extract made with a CO2
extractor like hash oil
|
1. Potency analysis
2. Mycotoxin screening
3. Residual solvent test
4. Pesticide screening
|
|
Concentrate or extract made with ethanol
|
1. Potency analysis
2. Mycotoxin screening
3. Residual solvent test
4. Pesticide screening
|
|
Concentrate or extract made with approved food grade
solvent
|
1. Potency 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. Potency analysis
2. Microbiological screening
3. Mycotoxin screening
4. Pesticide screening
|
|
Infused cooking oil or fat in solid form
|
1. Potency 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. Potency analysis
2. Water activity testing
|
|
Infused liquid (like a soda or tonic)
|
1. Potency analysis
|
|
Infused topical
|
1. Potency analysis
|
|
Cannabis mix packagedrolled)
|
1. Potency analysis
|
|
Cannabis mix infused (lrolled)
|
1. Potency analysis
|
|
Concentrate or cannabis-infused product
|
1. Potency analysis
|
(e)
End products consisting of only one intermediate product that has not been
changed in any way are not subject to potency 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 retested. 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 labs may reference samples for mycotoxins,
heavy metals, and pesticides testing to other certified labs by subcontracting
for those fields of testing. 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, and
receiving personnel.
(8) Certified
labs 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 lab 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 lab 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
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
