OAR 333-007-0440
Control Study

The purpose of a control study is to determine if a processor or processing site is using standard operating procedures (SOP) that result in a finished cannabinoid concentrate, extract or product that is homogeneous and for cannabinoid products meets the potency target identified in the SOPs.
(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 provides to a laboratory, in writing:
(a) A request for a control study on a form prescribed by the Authority or Commission; and
(b) For cannabinoid products provides:
(A) A reference number or name of the SOP for the product that is the subject of the control study, the version number of the SOP if applicable, and the date the SOP was created and last modified, if applicable;
(B) The amount of THC the processor or processing site intends the cannabinoid product to have per unit of sale of the product;
(C) The number of uniform units of sale in the process lot;
(D) The final weight of the unit of sale;
(E) The number of servings in the unit of sale, if applicable;
(F) Product category (examples include edible, tincture, topical, capsule); and
(G) The texture of product.
(c) For cannabinoid concentrates and extracts provides:
(A) A reference number or name of the SOP for the concentrate or extract that is the subject of the control study, the version number of the SOP if applicable, and the date the SOP was created and last modified, if applicable;
(B) The total weight of the batch;
(C) The final weight of the unit of sale, if applicable;
(D) Product category (concentrate or extract); and
(E) The texture of the concentrate or extract.
(d) A description of any variation of the product, concentrate or extract the processor or processing site intends to include under the control study that would be permitted under section (11) of this rule, including for each separate product, concentrate or extract the weight of the unit of sale and the number of servings in the unit of sale, if applicable.
(2) Sample increments taken for purposes of a control study may not be combined and must be taken in accordance with OAR 333-007-0360 (Sampling and Sample Size Requirements for Compliance Testing), Exhibit B, Table 5 or 6, incorporated by reference.
(3) Sample increments from a cannabinoid concentrate or extract must be tested for:
(a) Pesticides in accordance with OAR 333-007-0400 (Standards for Pesticides Compliance Testing);
(b) Solvents in accordance with OAR 333-007-0410 (Standards for Solvents Compliance Testing); and
(c) THC concentration in accordance with OAR 333-007-0430 (Standards for THC and CBD Compliance Testing) if the concentrate or extract is intended to be transferred or sold directly to a consumer or patient.
(4) Sample increments from a cannabinoid product must be tested for THC concentration in accordance with OAR 333-007-0430 (Standards for THC and CBD Compliance Testing), as calculated pursuant to OAR 333-064-0100 (Marijuana Item Sampling Procedures and Testing).
(5) During a control study a batch passes:
(a) Pesticide testing if each sample increment is below the action limit established in OAR 333-007-0400 (Standards for Pesticides Compliance Testing).
(b) Solvent testing if each sample increment is below the action limit established in OAR 333-007-0410 (Standards for Solvents Compliance Testing); and
(c) THC and CBD concentration testing if:
(A) The amount of THC and CBD, as calculated pursuant to OAR 333-064-0100 (Marijuana Item Sampling Procedures and Testing), between sample increments taken from the batch does not exceed 20 percent RSD;
(B) For cannabinoid products, the amount of THC in any sample increment, as calculated pursuant to OAR 333-064-0100 (Marijuana Item Sampling Procedures and Testing), does not exceed by more than 20 percent the amount of THC the processor or processing site intended the product to contain as described in section (1) of this rule, unless all sample increments are below 10 mg THC per unit of sale in which case this paragraph does not apply; and
(C) The amount or percentage of THC as calculated pursuant to OAR 333-064-0100 (Marijuana Item Sampling Procedures and Testing) for any sample increment does not exceed the maximum concentration limit permitted in a package by more than 10 percent as specified in OAR 333-007-0200 (Concentration and Serving Size Limits: Definitions, Purpose, Scope and Effective Date) to 333-007-0220 (Medical Marijuana Item Concentration Limits), 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 (Marijuana Item Sampling Procedures and Testing).
(7) A control study fails if:
(a) Any sample increment exceeds an action limit in OAR 333-007-0400 (Standards for Pesticides Compliance Testing) (Pesticides) or 333-007-0410 (Standards for Solvents Compliance Testing) (Solvents).
(A) A sample increment that exceeds an action limit may not be reanalyzed and retested under OAR 333-007-0450 (Failed Test Samples)(1) unless the laboratory determines that the result is due to laboratory error and the laboratory error is reported to the Authority or the Commission.
(B) A batch that has a sample increment fail for exceeding an action limit in OAR 333-007-0400 (Standards for Pesticides Compliance Testing), 333-007-0410 (Standards for Solvents Compliance Testing) may not be remediated under OAR 333-007-0450 (Failed Test Samples)(5)(a) or (7)(c) for purposes of passing the control study.
(C) A batch that has a sample increment fail for exceeding an action limit in OAR 333-007-0400 (Standards for Pesticides Compliance Testing) or 333-007-0410 (Standards for Solvents Compliance Testing) may be remediated for purposes of selling or transferring the cannabinoid concentrate, extract or product, if permitted under OAR 333-007-0450 (Failed Test Samples), but sample increments from that batch may not be resubmitted for a control study.
(b) The amount of THC or CBD in a cannabinoid concentrate, extract or product, as calculated pursuant to OAR 333-064-0100 (Marijuana Item Sampling Procedures and Testing), between sample increments taken from the batch exceeds:
(A) 20 percent RSD; or
(B) For cannabinoid products, the amount of THC the processor or processing site intended the product to contain as described in section (1) of this rule is exceeded by more than 20 percent, unless all sample increments are below 10 mg THC per unit of sale in which case this paragraph does not apply.
(c) The amount or percentage of THC as calculated pursuant to OAR 333-064-0100 (Marijuana Item Sampling Procedures and Testing) for any sample increment, exceeds the maximum concentration limit permitted in a package by more than 10 percent as specified in OAR 333-007-0200 (Concentration and Serving Size Limits: Definitions, Purpose, Scope and Effective Date) to 333-007-0220 (Medical Marijuana Item Concentration Limits), as applicable.
(A) A batch that has a sample increment fail under subsections (b) or (c) of this section may not be re-mixed or re-packaged under OAR 333-007-0450 (Failed Test Samples)(10)(a) or (b) for purposes of passing the control study.
(B) A batch that has a sample increment fail under subsections (b) or (c) of this section may be re-mixed or re-packaged for purposes of selling or transferring the cannabinoid concentrate, extract or product as permitted under OAR 333-007-0450 (Failed Test Samples)(10)(a) or (b), but sample increments from that batch may not be resubmitted for a control study.
(8) A process lot sampled and tested for purposes of a control study may be sold or transferred if the sample increments pass all the required tests.
(9) If a cannabinoid concentrate, extract or product successfully passes a control study and the control study has been certified by the Authority or the Commission, as applicable, the following applies to sampling and testing of future batches for two years except as provided in section (10) of this rule:
(a) For cannabinoid concentrates and extracts, sample increments may be collected and combined into a primary sample and a field duplicate sample as described in OAR 333-007-0360 (Sampling and Sample Size Requirements for Compliance Testing), Exhibit B, Table 7, OAR 333-064-0100 (Marijuana Item Sampling Procedures and Testing), ORELAP-SOP-002 Rev. 4.1.
(b) For cannabinoid products, at a minimum, one unit of sale must be collected, at random, for the primary sample, and one unit of sale must be collected at random for the field duplicate sample.
(c) Both the primary sample and the field duplicate sample must be prepared and analyzed individually for any test that is required for the marijuana item.
(10) The certification of a control study is invalidated:
(a) If a processor or processing site makes any changes:
(A) To the standard operating procedures for that cannabinoid concentrate, extract or product, including changes that alter the texture, weight or volume of the unit of sale, homogeneity or for products, expected THC potency.
(B) In the type of ingredient in the cannabinoid concentrate, extract or product, except as outlined in section (11) of this rule.
(b) If a cannabinoid concentrate, extract or product fails a THC or CBD test under OAR 333-007-0430 (Standards for THC and CBD Compliance Testing)(3)(a).
(11) For purposes of subsection (10)(a) 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 finished cannabinoid product.
(d) The same type or form of an ingredient in the same or substantially the same amount where the only change is the taste or color of the finished cannabinoid product but does not change the texture or weight of the finished cannabinoid product.
(12) A processor or processing site does not qualify for reduced sampling and testing under a control study until either the Authority or Commission:
(a) Reviews documentation associated with the control study;
(b) Certifies the control study; and
(c) Notifies the laboratory and the processor that the control study is considered certified.
(13) If a processor or processing site does not have a certified control study it must have the cannabinoid concentrate, extract or product sampled in accordance with OAR 333-007-0360 (Sampling and Sample Size Requirements for Compliance Testing), Exhibit B, Tables 5 and 6 and the sample increments prepared and analyzed separately.
(14) Any testing performed as part of a control study is considered a compliance test.
(15) A processor or processing site must report to the Authority or the Commission if a control study is invalidated under section (10) of this rule and failure to report is a violation of these rules.
(16) This rule also applies to producers producing kief under OAR 845-025-2020 (Producer Privileges; Prohibitions).

Source: Rule 333-007-0440 — Control Study, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-007-0440.

Last Updated

Jun. 8, 2021

Rule 333-007-0440’s source at or​.us