OHA Division 7 Rules / Labeling, Concentration Limits & Testing

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OREGON ADMINISTRATIVE RULES

OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION

CHAPTER 333

DIVISION 7

CANNABIS/MARIJUANA LABELING, CONCENTRATION LIMITS, AND TESTING

Temporary rules effective until May 30, 2017

_________________________________________________________________
                        333-007-0090      333-007-0310      333-007-0315      333-007-0320      333-007-0350  
                       333-007-0360      333-007-0410      333-007-0430      333-007-0440      333-007-0450  
                                                    333-007-0480      333-064-0100      333-064-0110
___________________________________________________________________________
333-007-0090
General Label Requirements; Prohibitions; Exceptions
(1) Principal Display Panel.
(a) Every container that contains a cannabis/marijuana item for sale or transfer to a consumer, patient or
designated primary caregiver must have a principal display panel, as that term is defined in OAR
333-007-0020.
(b) If a container is placed within packaging for purposes of displaying the marijuana item for
sale or transfer to a consumer, patient or designated primary caregiver, the packaging must have
a principal display panel as that term is defined in OAR 333-007-0020.
(c) The principal display panel must contain the product identity, net weight, and universal
symbol, if applicable.
(d) If the product is a medical grade cannabinoid product, concentrate or extract processed by a
licensee the principal display panel must include the medical grade symbol.
(2) A label required by these rules must:
(a) Be placed on the container and on any packaging that is used to display the marijuana item
for sale or transfer to a consumer, patient or designated primary caregiver.
(b) Comply with the National Institute of Standards and Technology (NIST) Handbook 130
(2016), Uniform Packaging and Labeling Regulation, incorporated by reference.
(c) Be in no smaller than 8 point Times New Roman, Helvetica or Arial font;
(d) Be in English, though it can be in other languages; and
(e) Be unobstructed and conspicuous.
(3) A marijuana item may have one or more labels affixed to the container or packaging.
(4) A marijuana item that is in a container that because of its size does not have sufficient space
for a label that contains all the information required for compliance with these rules:
(a) May have a label on the container that contains a marijuana item and on any packaging that is
used to display the marijuana item for sale or transfer to a consumer, patient or designated
primary caregiver that includes at least the following:
(A) Information required on a principal display panel, if applicable for the type of marijuana
item;
(B) Licensee or registrant business or trade name and licensee or registrant number;
(C) For licensees, package unique identification number and for registrants, batch or process lot
number;
(D) Concentration of THC and CBD; and
(E) Required warnings; and
(b) Must include all other required label information not listed in subsection (4)(a) of this rule on
an outer container or package, or on a leaflet that accompanies the marijuana item.
(c) May:
(A) Use a peel-back or accordion label with the information required in subsection (4)(b) of this
rule, if the peel-back or accordion label can be easily identified by a patient or consumer as
containing important information.
(B) Use 6 point font for the information listed in paragraph (4)(a)(A) to (D) of this rule.
(5) A cannabis/marijuana item in a container that is placed in packaging that is used to display the
marijuana item for sale or transfer to a consumer, patient, or designated primary caregiver must
comply with the labeling requirements in these rules, even if the container qualifies for the
exception under section (4) of this rule.
(6) The universal symbol:
(a) Must be at least 0.48 inches wide by 0.35 inches high.
(b) May only be used by licensees or registrants.
(c) May be downloaded at www.healthoregon.org/marijuana.
(7) Medical grade symbol. The medical grade symbol must be at least 0.35 inches in diameter.
(8) A label may not:
(a) Contain any untruthful or misleading statements including, but not limited to, a health claim
that is not supported by the totality of publicly available scientific evidence (including evidence
from well-designed studies conducted in a manner which is consistent with generally recognized
scientific procedures and principles), and for which there is significant scientific agreement,
among experts qualified by scientific training and experience to evaluate such claims; or
(b) Be attractive to minors, as that is defined in OAR 845-025-7000.
(9) A marijuana item that falls within more than one category, for example a product that is both
a cannabinoid concentrate and cannabinoid edible, must comply with the labeling requirements
that apply to both categories, with the exception of the “DO NOT EAT” warning if the product is
intended for human consumption or the “BE CAUTIOUS” warning if the effects of the product
are customarily felt immediately.
(10) The THC and CBD amount required to be on a label must be the value calculated by the
laboratory that did the testing in accordance with OAR 333-064-0100, plus or minus five
percent.
(11) If a marijuana item has more than one test batch number, laboratory, or test analysis date
associated with the marijuana item that is being sold or transferred, each test batch number,
laboratory and test analysis date must be included on a label.
(12) If a cannabis/marijuana item is placed in a package that is being re-used, the old label or labels must
be removed and it must have a new label or labels.
(13) A licensee or registrant must have documentation that demonstrates the validity of the
calculation of the amount of sodium, sugar, carbohydrates and total fat in a cannabinoid edible
and must make that documentation available to the Commission or the Authority upon request.
(14) Exit packaging must contain a label that reads: “Keep out of the reach of children.”
(15) Effective January 1, 2017, a cartridge containing a cannabinoid concentrate, extract or
product intended for use with an inhalant delivery system as that is defined in ORS 431.840 is
not required to be labeled in accordance with these rules except that the cartridge must have a
label with the universal symbol. All the remaining label requirements must be included on the
packaging that is used to display the cartridge for sale or transfer
333-007-0310
Definitions
For purposes of OAR 333-007-0300 through 333-007-0490:
(1) “Authority” means the Oregon Health Authority.
(2) “Batch” means:
(a) A quantity of usable marijuana from a harvest lot; or
(b) A quantity of cannabinoid concentrate or extract or cannabinoid product from a process lot.
(3) “Cannabinoid” means any of the chemical compounds that are the active constituents of
marijuana.
(4) “Cannabinoid concentrate or extract” means a substance obtained by separating cannabinoids
from marijuana by a mechanical, chemical or other process.
(5) “Cannabinoid edible” means food or potable liquid into which a cannabinoid concentrate or
extract or the dried leaves or flowers of marijuana have been incorporated.
(6)(a) “Cannabinoid product” means a cannabinoid edible or any other product intended for
human consumption or use, including a product intended to be applied to a person’s skin or hair,
that contains cannabinoids or the dried leaves or flowers of marijuana.
(b) “Cannabinoid product” does not include:
(A) Usable marijuana by itself;
(B) A cannabinoid concentrate or extract by itself; or
(C) Industrial hemp, as defined in ORS 571.300.
(7) “Cannabinoid capsule”:
(a) Means a small soluble container, usually made of gelatin that encloses a dose of a
cannabinoid product, concentrate or extract intended for human ingestion.
(b) Does not mean a cannabinoid suppository.
(8) “Cannabinoid suppository” means a small soluble container designed to melt at body
temperature within a body cavity other than the mouth, especially the rectum or vagina
containing a cannabinoid product, concentrate or extract.
(9) “Cannabinoid tincture” means a solution of alcohol, cannabinoid concentrate or extract, and
perhaps other ingredients intended for human consumption or ingestion, and that is exempt from
the Liquor Control Act under ORS 471.035.
(10) “Cannabinoid topical” means a cannabinoid product intended to be applied to skin or hair
and for purposes of testing includes transdermal patches.
(11) Cannabinoid Transdermal patch” means an adhesive substance applied to human skin that
contains a cannabinoid product, concentrate or extract for absorption into the bloodstream.
(12) “CBD” means cannabidiol, Chemical Abstracts Service Number 13956-29-1.
(13) “CBDA” means cannabidiolic acid, Chemical Abstracts Service Number 1244-58-2.
(14) “Chain of custody procedures” means procedures employed by laboratory personnel using a
chain of custody form to record the possession of samples from the time of sampling through the
retention time specified by the Authority or Commission.
(15) “Chain of custody form” means a form completed by laboratory personnel that documents
the collection, transport, and receipt of samples by the laboratory.
(16) “Commission” means the Oregon Liquor Control Commission.
(17) “Consumer” has the meaning given that term in ORS 475B.015 and does not include a
patient or designated primary caregiver.
(18) “Control study” means a study performed on products or matrices of unknown homogeneity
to assure required uniformity of product accomplished through sampling and testing as described
in OAR 333-007-0440
(19) “Delta-9 THC” is the principal psychoactive constituent (the principal cannabinoid) of
cannabis, Chemical Abstracts Service Number 1972-08-3.
(20)(a) “Designated primary caregiver” means an individual 18 years of age or older who has
significant responsibility for managing the well-being of a person who has been diagnosed with a
debilitating medical condition, who is designated as such on that person’s application for a
registry identification card or in other written notification to the Authority, and who has been
issued an identification card by the Authority under ORS 475B.415(5)(b).
(b) “Designated primary caregiver” does not include the person’s attending physician.
(21) “Field duplicate sample” means a sample taken in an identical manner from and
representative of the same marijuana item being sampled that is analyzed separately, that is used
for quality control only.
(22) “Food” means a raw, cooked, or processed edible substance, or ingredient used or intended
for use or for sale in whole or in part for human consumption, or chewing gum.
(23) “Grower” has the same meaning as “person responsible for a marijuana grow site.”
(24) “Grow site” means a specific location registered by the Authority and used by the grower to
produce marijuana for medical use by a specific patient under ORS 475B.420.
(25) “Harvest lot” means a specifically identified quantity of marijuana that is cultivated utilizing
the same growing practices, harvested within a 48-hour period at the same location and cured
under uniform conditions.
(26) “Homogeneous” means a cannabinoid product, concentrate or extract has uniform
composition and properties throughout each process lot.
(27) “Human consumption or human ingestion” means to ingest, generally through the mouth,
food, drink or other substances such that the substance enters the human body but does not
include inhalation.
(28) “Laboratory” means a laboratory that is accredited under ORS 438.605 to 438.620 to sample
or conduct tests on marijuana items and licensed by the Oregon Liquor Control Commission
under ORS 475B.560.
(29) “Licensee” has the meaning given that term in ORS 475B.015.
(30)(a) “Marijuana” means the plant Cannabis family Cannabaceae, any part of the plant
Cannabis family Cannabaceae and the seeds of the plant Cannabis family Cannabaceae.
(b) “Marijuana” does not include industrial hemp, as defined in ORS 571.300.
(31) “Marijuana item” means marijuana, usable marijuana, a cannabinoid product or a
cannabinoid concentrate or extract.
(32) “Marijuana processing site” means a marijuana processing site registered under ORS
475B.435.
(33) “Medical marijuana dispensary” or “dispensary” means a medical marijuana dispensary
registered under ORS 475B.450.
(34) “ORELAP” means the Oregon Environmental Laboratory Accreditation Program
administered by the Authority pursuant to ORS 438.605 to 438.620.
(35) “Patient” has the same meaning as “registry identification cardholder.”
(36) “Person responsible for a marijuana grow site” has the same meaning as “grower” and
means a person who has been selected by a patient to produce medical marijuana for the patient
and who has been registered by the Authority for this purpose under ORS 475B.420.
(37) “Process lot” means:
(a) Any amount of cannabinoid concentrate or extract of the same type and processed using the
same extraction methods, standard operating procedures and batches from the same or a different
harvest lot; or
(b) Any amount of a cannabinoid product of the same type and processed using the same
ingredients, standard operating procedures and batches from the same or a different harvest lot or
process lot of cannabinoid concentrate or extract as defined in subsection (a) of this section.
(38) “Processing” means the compounding or conversion of marijuana into cannabinoid products
or cannabinoid concentrates or extracts.
(39) “Processing site” means a processor registered with Authority under ORS 475B.435.
(40) “Processor” has the meaning given that term in OAR 845-025-1015.
(41) “Producer” has the meaning given that term in OAR 845-025-1015.
(42) “Producing” means:
(a) Planting, cultivating, growing, trimming or harvesting marijuana; or
(b) Drying marijuana leaves and flowers.
(43) “Registrant” means a grower, marijuana processing site, or a medical marijuana dispensary
registered with the Authority under ORS 475B.420, 475B.435 or 475B.450.
(44) “Registry identification cardholder” means a person who has been diagnosed by an
attending physician with a debilitating medical condition and for whom the use of medical
marijuana may mitigate the symptoms or effects of the person’s debilitating medical condition,
and who has been issued a registry identification card by the Authority under ORS
475B.415(5)(a).
(45) “Relative percentage difference” or “RPD” means the comparison of two quantities while
taking into account the size of what is being compared as calculated under OAR 333-064-0100..
(46) “Relative standard deviation” or “RSD” means the standard deviation expressed as a
percentage of the mean recovery as calculated under OAR 333-064-0100.
(47) “Sample” means an amount of a marijuana item collected by laboratory personnel from a
registrant or licensee and provided to a laboratory for testing.
(48) “Sterilization” means the removal of all microorganisms and other pathogens from a
marijuana item by treating it with approved chemicals or subjecting it to high heat.
(49) “Test batch” means a group of samples from a batch submitted collectively to a laboratory
for testing purposes.
(50) “THC” means tetrahydrocannabinol and has the same Chemical Abstracts Service Number
as delta-9 THC.
(51) “THCA” means tetrahydrocannabinolic acid, Chemical Abstracts Service Number 23978-
85-0.
(52) “These rules” means OAR 333-007-0300 through 333-007-0490.
(53) “TNI” means The NELAC (National Environmental Laboratory Accreditation Conference)
Institute, a voluntary organization of state and federal environmental officials and interest groups
purposed primarily to establish consensus standards for accrediting environmental laboratories.
(54) “TNI EL Standards” means the adopted 2009 TNI Environmental Lab Standards (© 2009
The NELAC Institute), which describe the elements of laboratory accreditation developed and
established by the consensus principles of TNI and that meet the approval requirements of TNI
procedures and policies.
(55) “Total THC” means the molar sum of THC and THCA.
(56)(a) “Usable marijuana” means the dried leaves and flowers of marijuana.

(b) “Usable marijuana” does not include:

(A) The seeds, stalks and roots of marijuana; or
(B) Waste material that is a by-product of producing or processing marijuana
333-007-0315
Ordering Tests
A registrant or licensee must provide a laboratory, prior to laboratory taking samples, with the
following:
(1) A written request of analysis for each test the laboratory is being requested to conduct.
(2) Notification of whether the batch is being re-sampled because of a failed test and the failed
test results.
(3) Certification of a successful control study, if applicable, on a form prescribed by the
Authority.

(4) Proof of a waiver under OAR 333-007-0490, if applicable

333-007-0320
Testing Requirements for Marijuana or Usable Marijuana
(1) A producer or grower must test every batch from a harvest lot of cannabis/marijuana or usable
cannabis/marijuana intended for use by a consumer or patient prior to selling or transferring the marijuana
or usable marijuana for the following:
(a) Pesticides in accordance with OAR 333-007-0400.
(b) Water activity and moisture content in accordance with OAR 333-007-0420.
(c) THC and CBD concentration in accordance with OAR 333-007-0430.
(2) A producer or grower must test every batch from a harvest lot of marijuana or usable
marijuana intended for use by a processor or processing site for water activity and moisture
content in accordance with OAR 333-007-0420 unless the processor or processing site uses a
method of processing that results in effective sterilization.
(3) A producer or grower must test a batch from a harvest lot of marijuana or usable marijuana
for microbiological contaminants in accordance with OAR 333-007-0390, upon written request
by the Authority or the Commission.
(4) In lieu of ordering and arranging for the sampling and testing required in this rule a producer
may transport batches of marijuana or usable marijuana to a wholesaler licensed by the
Commission under ORS 475B.100 and the wholesaler may order and arrange for the sampling
and testing of the batches, in accordance with rules established by the Commission
333-007-0350
Batch Requirements
(1) Usable marijuana. A producer or grower must separate each harvest lot into no larger than 10
pound batches.
(2) Cannabinoid concentrates and extracts.

(a) A process lot is considered a batch

(b) The size of a process lot submitted for sampling and testing for purposes of a control study
under OAR 333-007-0440 defines the maximum process lot for that concentrate, extract or
product for purposes of sampling and testing after a control study has been certified.
(3) Cannabinoid products. A processor or processing site must separate process lots into not
larger than 35,000 unit batches.
(4) A grower and processing site must assign each batch a unique batch number and that unique
batch number must be:
(a) Documented and maintained in the grower and processing site records for at least two years
and available to the Authority upon request;
(b) Provided to the individual responsible for taking samples; and
(c) Included on the batch label as required in OAR 333-007-0380.
(5) A grower and processing site may not reuse a unique batch number.
333-007-0360
Sampling and Sample Size
(1) Usable marijuana.
(a) Usable marijuana may only be sampled after it is cured, unless the usable marijuana is
intended for sale or transfer to a processor or processing site to make a cannabinoid concentrate
or extract.
(b) Samples taken must in total represent a minimum of 0.5 percent of the batch, consistent with
the laboratory’s accredited sampling policies and procedures, described in OAR 333-064-
0100(2).
(c) A portion of samples taken from multiple batches of usable marijuana may be combined for
purposes of testing for THC and CBD if the batches are the same strain, regardless of the size of
the multiple batches.
(d) A portion of samples taken from multiple batches of usable marijuana may be combined for
purposes of testing for pesticides if the multiple batches in total do not exceed 10 pounds. If the
combined samples fail for pesticides all the batches fail.
(2) Cannabinoid concentrates, extracts and products.
(a) At a minimum, samples must be taken in increments established in Exhibit B, incorporated
by reference. Enough samples from a batch must be taken to ensure that the required attributes in
the batch to be tested are homogenous and must be taken in a manner consistent with the
laboratory’s accredited sampling policies and procedures described in OAR 333-064-0100(2).
(b) If a cannabinoid concentrate, extract or product has successfully passed a control study,
future batches of that concentrate, extract or product with a control study certification, as
described in OAR 333-007-0440, may have samples collected in increments prescribed in
Exhibit B, Table 7 or 8, as applicable, and the sample increments may be combined into a field
primary sample and a field duplicate sample in accordance with OAR 333-007-0440 and OAR
333-064-0100(2). Both the field primary and the field duplicate samples must be tested and may
not be combined.
(3) Sufficient sample size must be taken for analysis of all required tests and the quality control
performed by the testing laboratory for these tests
333-007-0410
Standards for Testing Solvents
(1) A marijuana item required to be tested for solvents must be tested by a laboratory for the
analytes listed in Exhibit A, Table 4 incorporated by reference.
(2) A batch fails solvent testing if a laboratory, during an initial test where no reanalysis is
requested or upon reanalysis as described in OAR 333-007-0450(1):
(a) Detects the presence of a solvent above the action level listed in Exhibit A, Table 4 in a
sample; or [Table not included. See ED. NOTE.]
(b) Calculates a RPD of more than 20 percent between the field primary result of the sample and
the field duplicate result.
(3) The Authority will review and update, if necessary, the analytes listed in Exhibit A, Table 4,
at least every two years.
333-007-0430
Standards for THC and CBD Testing
(1) A laboratory must test for the following when testing a marijuana item for potency:
(a) THC.
(b) THCA.
(c) CBD.
(d) CBDA.
(2) A process lot of a cannabinoid concentrate, extract or product that has not successfully
completed a control study fails potency testing if, based on an initial test where no reanalysis is
requested or upon reanalysis as described in OAR 333-007-0450(1):
(a) The amount of THC, as calculated pursuant to OAR 333-064-0100, between samples taken
from the batch exceeds 30 percent RSD; or
(b) The amount or percentage of THC, as calculated pursuant to OAR 333-064-0100, exceeds the
maximum concentration limits permitted in package by over 5 percent as specified in OAR 333-
007-0200 to 333-007-0220, as applicable.
(3) A process lot of a cannabinoid concentrate, extract or product that has successfully completed
a control study fails potency testing if, based on an initial test where no reanalysis is requested or
upon reanalysis as described in OAR 333-007-0450(1):
(a) The amount of THC, as calculated pursuant to OAR 333-064-0100, between the sample and
the field duplicate exceeds 20 percent RPD; or
(b) The amount or percentage of THC, as calculated pursuant to OAR 333-064-0100, exceeds the
maximum concentration limits permitted in a package by over 5 percent as specified in OAR
333-007-0200 to 333-007-0220, as applicable
(4) A sample cannot fail CBD testing
(5) Notwithstanding section (2)(a) and (3)(a) of this rule, a sample that has less than 5 mg of
THC as calculated pursuant to OAR 333-064-0100 does not fail potency testing based on
exceedance of the RSD or RPD as described in section (2)(a) or (3)(a) of this rule.
333-007-0440
Control Study
(1) A laboratory may perform a control study on a process lot of cannabinoid concentrates,
extracts or products for a processor or processing site if the processor or processing site informs
the laboratory, in writing:
(a) That sampling and testing is for the purposes of a control study; and
(b) For cannabinoid products, the expected THC range for the product.
(2) Samples taken for purposes of a control study may not be combined.
(3) Samples of cannabinoid concentrate and extracts must be tested for:
(a) Pesticides in accordance with OAR 333-007-0400,
(b) Solvents in accordance with OAR 333-007-0410.
(4) Samples of cannabinoid products must be tested for THC concentration in accordance with
OAR 333-007-0430, as calculated pursuant to OAR 333-064-0100.
(5) During a control study a batch passes:
(a) Pesticide testing if each sample is below the action limit established in OAR 333-007-0400.
(b) Solvent testing if:
(A) Each sample is below the action limit established in OAR 333-007-0410; and
(B) The results above the LOQ are not greater than 30 percent RSD between samples.
(c) THC concentration testing if:
(A) The amount of THC, as calculated pursuant to OAR 333-064-0100, between samples taken
from the batch does not exceed 30 percent RSD; and
(B) The amount or percentage of THC as calculated pursuant to OAR 333-064-0100, does not
exceed the maximum concentration limit permitted in a package by more than 5 percent as
specified in OAR 333-007-0200 to 333-007-0220, as applicable.
(6) A laboratory must identify on a form prescribed by the Authority if a batch undergoing a
control study has passed for any of the following, and must send the form at the client’s request
to the Authority or the Commission:
(a) Pesticides, if applicable.
(b) Solvents, if applicable.
(c) THC concentration as calculated pursuant to OAR 333-064-0100, if applicable.
(7) A control study fails if:
(a) Any sample exceeds an action limit in OAR 333-007-0400 or 333-007-0410. A sample that
exceeds an action limit may not be reanalyzed and retested under OAR 333-007-0450(1) unless
the laboratory determines that the result is due to laboratory error.
(b) The amount of THC, as calculated pursuant to OAR 333-064-0100, between samples taken
from the batch exceeds 30 percent RSD.
(c) The amount or percentage of THC as calculated pursuant to OAR 333-064-0100, exceeds the
maximum concentration limit permitted in a package by more than 5 percent as specified in
OAR 333-007-0200 to 333-007-0220, as applicable
(8) A process lot sampled and tested for purposes of a control study may be sold or transferred if
the samples pass all the required tests.
(9) If a cannabinoid concentrate, extract or product successfully passes a control study the
following apply to sampling of future batches for one year:
(a) Sample increments may be collected and combined into a primary sample and a field
duplicate sample as described in OAR 333-007-0360, Example B, Table 7 or 8, as applicable,
OAR 333-064-0100, and ORELAP-SOP-002 Rev. 3.1.
(b) The primary sample and the field sample must be tested and may not be combined.
(10) The certification of a control study is invalidated if a processor or processing site makes any
changes:
(a) To the standard operating procedures for that product.
(b) In the type of ingredient in the product.
(11) For purposes of section (10) of this rule it is not considered a change to standard operating
procedures or a change in the type of ingredient if the processor or processing site is using:
(a) Different strains of usable marijuana in batches.
(b) An ingredient with a different level of purity as long as the purity of the ingredient complies
with the Authority’s or the Commission’s processing rules.
(c) Different flavors or colors in batches, as long as the different flavors or colors do not have an
effect on the potency of the product.
(12) The Authority will certify a control study for registrants. The Commission will certify a
control study for licensees
333-007-0450
Failed Test Samples
(1) If a sample fails any initial test the laboratory that did the testing may reanalyze the sample.
If the sample passes, another laboratory must resample the batch and confirm that result in order
for the batch to pass testing.
(a) If a registrant or licensee wishes to have a sample reanalyzed, the registrant or licensee must
request a reanalysis within seven calendar days from the date the laboratory sent notice of the
failed test to the registrant or licensee. The reanalysis must be completed by the laboratory
within 30 days from the date the reanalysis was requested.
(b) If a registrant or licensee has requested a reanalysis in accordance with subsection (1)(a) of
this rule and the sample passes, the registrant or licensee has seven calendar days from the date
the laboratory sent notice of the passed test to request that another laboratory resample the batch
and confirm the passed test result. The retesting must be completed by the second laboratory
within 30 days from the date the retesting was requested.
(c) A registrant or licensee must inform the Authority or the Commission immediately, of the
following, in a manner prescribed by the Authority or the Commission:
(A) A request for reanalysis of a sample;
(B) The testing results of the reanalysis;
(C) A request for retesting; and
(D) The results of retesting.
(2) If a sample fails a test or a reanalysis under section (1) of this rule the batch:
(a) May be remediated or sterilized in accordance with this rule; or
(b) If it is not or cannot be remediated or sterilized under this rule, must be destroyed in a manner
specified by the Authority or the Commission.
(3) If a licensee or registrant is permitted under this rule to sell or transfer a batch that has failed
a test, the licensee or registrant must notify the licensee or registrant to whom the batch is sold or
transferred of the failed test.
(4) Failed microbiological contaminant testing.
(a) If a sample from a batch of usable cannabis/marijuana fails microbiological contaminant testing the
batch may be used to make a cannabinoid concentrate or extract if the processing method
effectively sterilizes the batch, such as a method using a hydrocarbon based solvent or a CO2
closed loop system.
(b) If a sample from a batch of a cannabinoid concentrate or extract fails microbiological
contaminant testing the batch may be further processed if the processing method effectively
sterilizes the batch, such as a method using a hydrocarbon based solvent or a CO2 closed loop
system.
(c) A batch that is sterilized in accordance with subsection (a) or (b) of this section must be
sampled and tested in accordance with these rules and must be tested if not otherwise required
for that product, for microbiological contaminants, solvents and pesticides.
(d) A batch that fails microbiological contaminant testing after undergoing a sterilization process
in accordance with subsection (a) or (b) of this section must be destroyed in a manner specified
by the Authority or the Commission.
(5) Failed solvent testing.
(a) If a sample from a batch fails solvent testing the batch may be remediated using procedures
that would reduce the concentration of solvents to less than the action level.
(b) A batch that is remediated in accordance with subsection (a) of this section must be sampled
and tested in accordance with these rules and must be tested if not otherwise required for that
product under these rules, for solvents and pesticides.
(c) A batch that fails solvent testing that is not remediated or that if remediated fails testing must
be destroyed in a manner specified by the Authority or the Commission.
(6) Failed water activity testing.
(a) If a sample from a batch of usable marijuana fails for water activity the batch from which the
sample was taken may:
(A) Be used to make a cannabinoid concentrate or extract; or
(B) Continue to dry or cure.
(b) A batch that undergoes additional drying or curing as described in paragraph (a)(B) of this
section must be sampled and tested in accordance with these rules.
(7) Failed pesticide testing.
(a) If a sample from a batch fails pesticide testing the batch may not be remediated and must be
destroyed as ordered by the Authority or the Commission. A batch may not be destroyed
without obtaining permission from the Authority or the Commission.
(b) The Authority must report to the Oregon Department of Agriculture all test results that show
that a sample failed a pesticide test, in accordance with OAR 333-008-0650.
(8) Failed potency testing.
(a) A cannabis/marijuana item that fails potency testing under OAR 333-007-0430(2)(a) or (3)(a) may be
repackaged in a manner that enables the item to meet the standard in OAR 333-007-0430(2)(a)
or (3)(a)
(b) A cannabis/marijuana item that is repackaged in accordance with this section must be sampled and
tested in accordance with these rules.
(9) If a sample fails a test after undergoing remediation or sterilization as permitted under this
rule the batch must be destroyed in a manner approved by the Authority or the Commission.
(10) A registrant must inform a laboratory prior to samples being taken that the batch has failed a
test and is being retested after undergoing remediation or sterilization.
(11) A registrant must, as applicable:
(a) Have detailed procedures for sterilization processes to remove microbiological contaminants
and for reducing the concentration of solvents.
(b) Document all sampling, testing, sterilization, remediation and destruction that are a result of
failing a test under these rules.
(12) If a batch fails a test under these rules a registrant:
(a) Must store and segregate the batch in a secure area and label the batch clearly to indicate it
has failed a test and the label must include a test batch number.
(b) May not remove the batch from the registered premises without permission from the
Authority
333-007-0480
Audit and Random Testing
(1) The Authority may require a registrant to submit samples identified by the Authority to a
laboratory of the registrant’s choosing to be tested in order to determine whether a registrant is in
compliance with OAR 333-007-0300 through 333-007-0490, and may require additional testing
that is not required by these rules.
(2) A laboratory doing audit testing must comply with these rules, to the extent they are
applicable, and if conducting testing not required by these rules, may only use Authority
approved methods.
(3) The Authority must establish a process for the random testing of marijuana items for
microbiological contaminants that ensures each registrant tests every product for microbiological
contaminants at least once a year.
(4) Any testing ordered under this rule must be paid for by the registrant.
333-064-0100
Marijuana Item Sampling Procedures and Testing
(1) For purposes of this rule the definitions in OAR 333-007-0310 apply unless the context
indicates otherwise.
(2) Sampling.
(a) A laboratory must prepare cannabis/marijuana item sampling policies and procedures that contain all of the information necessary for collecting and transporting samples from a marijuana item in a
manner that does not endanger the integrity of the sample for any analysis required by this rule.
These policies and procedures must be appropriate to the matrix being sampled.
(b) Sampling policies and procedures must be accredited by ORELAP prior to any cannabis/marijuana
samples being taken. The policies and procedures must be consistent with the following
ORELAP sampling protocols approved by the accrediting body, incorporated by reference:
(A) Usable cannabis/Marijuana: ORELAP-SOP-001 Rev 3.0; and
(B) Concentrates, Extracts, and Products: ORELAP-SOP-002 Rev 3.1.[Sampling protocols may
be found on the ORELAP and Cannabis Testing webpage,
public.health.oregon.gov/LaboratoryServices/EnvironmentalLaboratoryAccreditation/Pages/cann
abis-info.aspx]
(c) Care should be taken by laboratory personnel while sampling to avoid contamination of the
non-sampled material. Sample containers must be free of analytes of interest and appropriate for
the analyses requested.
(d) A sufficient sample size must be taken for analysis of all requested tests and the quality
control performed by the testing laboratory for these tests.
(e) A laboratory must comply with any recording requirements for samples and subsamples in
the accredited policies and procedures and at a minimum:
(A) Record the location of each sample and subsample taken.
(B) Assign a field identification number for each sample, subsample and field duplicate that have
an unequivocal link to the laboratory analysis identification.
(C) Assign a unique identification number for the test batch in accordance with OAR 333-007-
0370 and TNI EL standard requirements.
(D) Have a documented system for uniquely identifying the samples to be tested to ensure there
can be no confusion regarding the identity of such samples at any time. This system must include
identification for all samples, subsamples, preservations, sample containers, tests, and
subsequent extracts or digestates.
(E) Place the laboratory identification code as a durable mark on each sample container.
(F) Enter a unique identification number into the laboratory records. This number must be the
link that associates the sample with related laboratory activities such as sample preparation. In
cases where the sample collector and analyst are the same individual, or the laboratory pre-
assigns numbers to sample containers, the unique identification number may be the same as the
field identification code.
(f) Combining subsamples.
(A) Subsamples collected from the same batch must be combined into a single sample by a
laboratory prior to testing unless the batch is undergoing a control study or has not yet gone
through a control study.
(B) Subsamples and samples collected from different batches may not be combined.
(C) Field duplicates may not be combined with the primary samples.
(3) THC and CBD testing validity. When testing a sample for THC and CBD a laboratory must
comply with additional method validation as follows:
(a) Run a laboratory control standard in accordance with TNI standards requirements within
acceptance criteria of 70 percent to 130 percent recovery.
(b) Analyze field duplicates of samples within precision control limits of plus or minus 20
percent RPD, if field duplicates are required.
(4) 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) Each test report must include the total THC and total CBD.
(5) Report total THC and total CBD as Dry Weight. A laboratory must report total THC and
Total CBD content by dry weight calculated as follows:
P total THC(dry) = P total THC(wet) / [1-(P moisture/100)]
P total CBD(dry) = P total CBD(wet) / [1-(P moisture/100)]
(6) Calculating RPD and RSD.
(a) A laboratory must use the following calculation for determining RPD:
RPD= (sample result–duplicate result)(sample result+duplicate result2
(b) A laboratory must use the following calculation for determining RSD:
% RSD= sx x100%
s=i=0n(xi–x)2(n–1)
(c) For purposes of this section:
(A) S = standard deviation.
(B) n = total number of values.
(C) xi = each individual value used to calculate mean.
(D) x = mean of n values.
(d) For calculating both RPD and RSD if any results are less than the LOQ the absolute value of
the LOQ is used in the equation.
(7) Tentative Identification of Compounds (TIC).
(a) If a laboratory is using a gas chromatography mass spectrometry instrument for analysis
when testing cannabinoid concentrates or extracts for solvents and determines that a sample may
contain compounds that are not included in the list of analytes the laboratory is testing for the
laboratory must attempt to achieve tentative identification.
(b) Tentative identification is achieved by searching NIST 2014 or an equivalent database
(>250,000 compounds).
(c) A laboratory shall report to the licensee or registrant and the Authority or the Commission,
depending on which agency has jurisdiction, up to five tentatively identified compounds (TICS)
that have the greatest apparent concentration.
(d) Match scores for background subtracted or deconvoluted spectra should exceed 90 percent
compared to library spectrum.
(A) The top five matches over 90 percent must be reported by the lab
(B) TIC quantitation is estimated by comparing analyte area to the closest internal standard area
and assuming a response factor (RF) =1.
(8) A laboratory must provide:
(a) Any pesticide test result to the Department of Agriculture upon that agency’s request.
(b) A sample or a portion of a sample to the Department of Agriculture upon that agency’s
request, document the chain of custody from the laboratory to the Department, and document
that the sample or portion of the sample was provided to the Department in the Commission’s
seed to sale tracking system
9) A laboratory performing tests for a licensee must enter any information required by the
Commission in the Commission’s seed to sale tracking system.
(10) A laboratory performing tests for a registrant must comply with the documentation
requirements in OAR 333-007-0370.
(11) The Authority may, in its discretion, deviate from TNI Standards in order to comply with
OAR 333-007-0400 to 333-007-0490 and these rules based on the state’s needs
333-064-0110
Reporting Marijuana Test Results
(1) For purposes of this rule the definitions in OAR 333-007-0310 apply unless the context
indicates otherwise.
(2) A test report must clearly identify for the licensee or registrant:
(a) Whether a sample has exceeded an action limit for an analyte in Exhibit A, Tables 3 or 4, or
has otherwise failed a test as described in OAR 333-007-0300 to 333-007-0490.
(b) A “detected” pesticide result as required in section (6) of this rule.
(c) The batch unique identification number required under OAR 333-007-0350 and the test batch
number associated with the samples tested, as required by OAR 333-064-0100.
(3) Within 24 hours of completion of the laboratory’s data review and approval procedures a
laboratory must report all failed tests for testing required under OAR 333-007-0300 to 333-007-
0490 except for failed water activity, whether or not the lab is reanalyzing the sample under
OAR 333-007-0450:
(a) Into the Commission’s seed to sale tracking system if performing testing for a licensee; and
(b) To the Authority electronically at www.healthoregon.org/ommp if performing testing for a
registrant.
(4) The laboratory must report all test results required under OAR 333-007-0300 to 333-007-
0490 that have not been reported under section (3) of this rule into the Commission’s seed to sale
tracking system if performing testing for a licensee.
(5) A laboratory must determine and include on each test report its limit of quantification (LOQ)
for each analyte listed in OAR 333-007-0400 Table 3 and OAR 333-007-0410 Table 4.
(6) When reporting pesticide testing results the laboratory must include in the report any target
compound that falls below the LOQ that has a signal to noise ratio of greater than 5:1 and meets
identification criteria with a result of “detected.”
(7) After January 31, 2017, a laboratory must include in a test report the results of all associated
batch quality control samples, with the date of analysis of the quality control samples and the
acceptance limits used to determine acceptability.
(a) Batch quality control samples are the method blank and laboratory control sample.
(b) The report must clearly show the association to the client samples in the report by listing the
batch identification numbers.
(8) A laboratory that is reporting failed test results to the Commission or the Authority in
accordance with section (3) of this rule must report the failed test at the same time or before
reporting to the licensee or registrant.
(9) If requested by the Authority, a laboratory must report aggregate information about numbers

of tests performed, number of tests where analytes are detected but are below the action limits,

and de-identified pesticide and solvent testing reports where a sample passed testing but with a
“detected” as described in section (6) of this rule.
(10) Test results expire after one year
 
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