Or. Admin. R. 333-007-0450 - Failed Test Samples
(1) If a sample
or a duplicate sample (collectively referred to as "sample" for purposes of
this rule) fails any initial test the laboratory that did the testing may
reanalyze the sample. The laboratory that did the initial test may not
subcontract the reanalysis. If a primary sample or a duplicate sample fails,
both must be reanalyzed. 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 requests 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. The second laboratory performing the
retesting:
(A) May not be performed at a
laboratory under the same ownership as the original laboratory that performed
the testing.
(B) May not be done by
a laboratory that was subcontracted to do the original testing.
(C) May only conduct retesting for the
compliance test that initially failed.
(c) If reanalysis in accordance with
subsection (1)(a) or retesting in accordance with subsection (1)(b) is ordered,
then the batch must remain in its original quantity as it was initially
submitted to the laboratory for testing and may not be subdivided.
(d) A registrant must inform the Oregon
Health Authority (Authority) immediately, of the following, in a manner
prescribed by the Authority:
(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.
(b) Must
be destroyed in a manner specified by the Authority or the Oregon Liquor and
Cannabis Commission (Commission) if it is not or cannot be remediated or
sterilized under this rule.
(c) May
not be combined with other batches as part of remediation or further
processing.
(3) If a
registrant is permitted to remediate or sterilize under this rule, the
registrant must provide notice to the Authority of the registrant's intent to
remediate or sterilize.
(4) Except
as otherwise permitted under this rule, a cannabinoid concentrate, extract,
finished inhalable cannabinoid product, or industrial hemp-derived vapor item
that is permitted to undergo remediation cannot be further processed into a
cannabinoid product during the remediation process.
(5) 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.
(6) Failed microbiological contaminant
testing.
(a) If a sample from a batch of
marijuana or usable marijuana fails microbiological contaminant testing the
batch may either:
(A) Be remediated using a
sterilization process; or
(B) 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, extract, finished inhalable cannabinoid product, or industrial
hemp-derived vapor item 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
remediated through a sterilization process in accordance with subsection (a) or
(b) of this section must be sampled in accordance with OAR 333-007-0360 and
must be tested for:
(A) Microbiological
contaminants;
(B) Solvents if
required per OAR 333-007-0410;
(C)
Pesticides;
(D) Water activity and
moisture content if required per OAR 333-007-0420;
(E) Potency in accordance with OAR
333-007-0430(1);
(F) Heavy metals
if the marijuana item or industrial hemp-derived vapor item was harvested or
manufactured on or after March 1, 2023; and
(G) Mycotoxins if the marijuana item or
industrial hemp-derived vapor item was harvested or manufactured on or after
July 1, 2022.
(d) A
batch that fails microbiological contaminant testing after undergoing
remediation through a sterilization process in accordance with paragraph (a)(A)
of this section must be destroyed in a manner specified by the Authority or the
Commission, or may be further processed as described in paragraph (a)(B) of
this section.
(7) 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 re-sampled in accordance with OAR
333-007-0360 and must be re-tested for:
(A)
Solvents;
(B) Pesticides;
(C) Potency in accordance with OAR
333-007-0430(1);
(D) Heavy metals
if the marijuana item or industrial hemp-derived vapor item was manufactured on
or after March 1, 2023;
(E)
Mycotoxins if the marijuana item or industrial hemp-derived vapor item was
manufactured on or after July 1, 2022; and
(F) Microbiological contaminants if the
marijuana item or industrial hemp-derived vapor item was manufactured on and
after March 1, 2023.
(c)
A batch that fails solvent testing that is not remediated must be destroyed in
a manner specified by the Authority or the Commission.
(8) Failed water activity or moisture content
testing.
(a) If a sample from a batch of
marijuana or usable marijuana fails for water activity or moisture content the
batch from which the sample was taken may:
(A)
Be used to make a cannabinoid concentrate or extract if the processing method
effectively sterilizes the batch; 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 re-sampled in accordance with OAR 333-007-0360 and re-tested for:
(A) Pesticides;
(B) Water activity and moisture
content;
(C) Potency in accordance
with OAR 333-007-0430(1);
(D) Heavy
metals if the marijuana or usable marijuana was harvested on or after March 1,
2023;
(E) Mycotoxins if the
marijuana or usable marijuana was harvested on or after July 1, 2022;
and
(F) Microbiological
contaminants if the marijuana or usable marijuana was harvested on and after
March 1, 2023.
(9) Failed pesticide testing.
(a) If a sample from a batch of marijuana or
usable marijuana fails pesticide testing the batch may not be remediated and
must be destroyed as ordered by the Authority or the Commission, except as
permitted under subsection (c) of this section. 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 of usable
marijuana failed a pesticide test.
(c) If a sample from a batch of marijuana or
usable marijuana fails pesticide testing but only for the analytes piperonyl
butoxide or pyrethrins, and the Oregon Department of Agriculture determines
that the products used were listed on the Department's Guide List for
Pesticides and Cannabis and the product was applied in accordance with the
label, the Authority or the Commission may permit the producer or grower to
remediate the usable marijuana using procedures that would reduce the
concentration of pesticides to less than the action level. A batch of usable
marijuana that is permitted to be remediated must be re-sampled in accordance
with OAR 333-007-0360 and re-tested for:
(A)
Pesticides;
(B) Water activity and
moisture content;
(C) Potency in
accordance with OAR 333-007-0430(1);
(D) Microbiological contaminates if the
marijuana item was harvested on or after March 1, 2023;
(E) Heavy metals if the marijuana item was
harvested on or after March 1, 2023; and
(F) Mycotoxins if the marijuana item was
harvested on or after July 1, 2022.
(d) If a processor or a processing site is
only processing with marijuana or usable marijuana that has passed pesticide
testing in accordance with OAR 333-007-0400 and a sample from a batch of a
cannabinoid concentrate or extract fails pesticide testing the batch may be
remediated using procedures that would reduce the concentration of pesticides
to less than the action level.
(e)
If a batch of industrial hemp-derived vapor item fails pesticides testing, it
may only be remediated using procedures that would reduce the concentration of
pesticides to less than the action level if the input material used to make the
industrial hemp-derived vapor item passed pesticide testing in accordance with
OAR 333-007-0400.
(f) A batch that
is remediated in accordance with subsection (d) or (e) of this section must be
re-sampled in accordance with OAR 333-007-0360 and re-tested for:
(A) Pesticides;
(B) Potency in accordance with OAR
333-007-0430(1);
(C) Solvent
testing if required per OAR 333-007-0410;
(D) Heavy metals;
(E) Mycotoxins; and
(F) Microbiological contaminants.
(g) If a sample from a batch of
finished inhalable cannabinoid products fails pesticide testing, the batch may
not be remediated and must be destroyed in a manner specified by the Authority
or the Commission.
(h) A batch that
is remediated but after being re-sampled and re-tested fails pesticide testing
must be destroyed as ordered by the Authority or the Commission.
(10) Failed potency testing.
(a) A marijuana item or industrial
hemp-derived vapor item that fails potency testing under OAR 333-007-0430(2)(b)
may be repackaged in a manner that enables the item to meet the concentration
limit standards in the Commission's concentration limit rules in OAR chapter
845, division 26, as applicable. A marijuana item or industrial hemp-derived
vapor item that is repackaged in accordance with this subsection must be
re-sampled and re-tested in accordance with these rules.
(b) A marijuana item or industrial
hemp-derived vapor item that fails potency testing under OAR 333-007-0430(2)(a)
may be re-mixed to meet the standards in OAR 333-007-0430(2)(a). A marijuana
item or industrial hemp-derived vapor item that is re-mixed must be re-sampled
in accordance with OAR 333-007-0360 and re-tested in accordance with these
rules for the marijuana item or industrial hemp-derived vapor item for:
(A) Pesticides;
(B) Potency in accordance with OAR
333-007-0430(1);
(C) Solvent
testing if required per OAR 333-007-0410;
(D) Heavy metals if the marijuana item or
industrial hemp-derived vapor item is or was manufactured on or after March 1,
2023;
(E) Mycotoxins if the
marijuana item or industrial hemp-derived vapor item is or was manufactured on
or after July 1, 2022; and
(F)
Microbiological contaminants if the marijuana item or industrial hemp-derived
vapor item is or was manufactured on and after March 1, 2023.
(11) Failed heavy metal
testing.
(a) If a sample from a batch of
marijuana or usable marijuana fails heavy metal testing, the batch may be
remediated by processing into a cannabinoid concentrate or extract if the
processing method reduces the concentration of heavy metals to less than the
action levels.
(b) If a sample from
a cannabinoid concentrate or extract fails heavy metal testing, the batch may
be remediated using procedures that would reduce the concentration of heavy
metals to less than the action level.
(c) If a sample from a batch of finished
inhalable cannabinoid product or industrial hemp-derived vapor item fails for
heavy metals, the batch may not be remediated and must be destroyed in a manner
specified by the Authority or Commission.
(d) A batch that is remediated in accordance
with subsection (a) or (b) of this section must be re-sampled in accordance
with OAR 333-007-0360 and re-tested for:
(A)
Pesticides;
(B) Solvents if
required under OAR 333-007-0410;
(C) Potency in accordance with OAR
333-007-0430(1);
(D) Heavy
metals;
(E) Mycotoxins;
and.
(F) Microbiological
contaminants.
(e) A
batch that fails heavy metal testing that is not remediated must be destroyed
in a manner specified by the Authority, Commission, or the Department of
Agriculture.
(12) Failed
mycotoxin testing. If a sample from a batch of a marijuana item or industrial
hemp-derived vapor item fails mycotoxin testing the batch may not be remediated
and must be destroyed in a manner specified by the Authority, Commission, or
the Department of Agriculture.
(13)
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.
(14) 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.
(15)
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.
Notes
Statutory/Other Authority: ORS 475C.544
Statutes/Other Implemented: ORS 475C.544
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