October 1, December 2, and December 14, 2016 Testing Rule Changes
The following is not comprehensive. Please click here for up-to-date details on regulatory requirements.
What Changed on December 14?
The following is not comprehensive, but just a brief overview of some of the most applicable changes. We encourage you to review the temporary OAR 333-007 rules for more information.
- The batch size for infused products was changed from 1000 units (as it was defined on Dec. 2) to 32,000 units
- Clarification was issued for sampling of batches after a Control Study waiver to indicate how many increments make up a primary sample vs. a field duplicate.
- Provisions have been made that allow processors that have undergone Process Validation studies under previous rules may apply for a Control Study waiver.
Read the state's written description of primary changes and justifications for changes here.
What Changed on December 2nd?
The following is not comprehensive, but just a brief overview of some of the most applicable changes. We encourage you to review the temporary OAR 333-007 rules for more information.
- Dispensaries must now display potency results on products as +/- 5%
- The definition of "harvest lot" changed to represent "usable marijuana" that was harvested within 48 hours of each other.
- Batch sizes for edibles and infused products is now capped at 1000 units.
- "Control Study" replaced "Process Validations"; see What are Control Studies? section below
- Residual Solvent and Sampling waivers have been repealed.
- Butanol, Propanol, and Ethanol have been removed from the residual solvents list required for testing
- If a test fails for pesticides or solvents, clients have 7 calendar days to request retesting
- Different batches of the same strain of "usable marijuana" may be combined for potency testing.
- Reminder: A "batch" is a subunit of a harvest lot.
- Only batches of the same harvest lot, as newly defined, being sampled at one time may be combined for testing.
- Different batches of "usable marijuana" may be combined, up to 10lb total combined batch weight, for pesticide testing.
- Reminder: A "batch" is a subunit of a harvest lot.
- Only batches of the same harvest lot, as newly defined, being sampled at one time may be combined for testing.
- If the pesticide test fails, all batches included in the combined sample fail and must be destroyed.
Contact us to learn more about the December 2nd, 2016 temporary rules, how they might affect your business, and how to take advantage of the potential cost savings afforded by these changes!
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Review of Oregon Testing Requirements According to OAR 333-007
Usable Cannabis:
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Extracts/Concentrates:
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Edibles:
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Other Infused Products:
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Microbiological testing may be requested by the Oregon Health Authority or Oregon Liquor Control Commission at a later time, but is currently not required for compliance with OAR 333-007.
Review of New Sampling Requirements
Since October 1st, 2016, all Cannabis materials to be tested for regulatory compliance with OAR 333-007 must be sampled according to a specific set of sampling guidelines released by ORELAP. Broadly this means that the laboratory will be collecting more sample increments.
Use the links below to learn more about these new sampling procedures:
- For OLCC licensed clients, please schedule a sampling event with the laboratory. Laboratory staff will visit your site and collect random samples directly from packages associated with a harvest or process lot. It is recommended to schedule sampling visits at least two weeks in advance.
- OHA licensed clients may continue to bring in batches directly to the laboratory for random sampling. Contact us to schedule a batch sampling appointment at the laboratory.
Use the links below to learn more about these new sampling procedures:
Sampling Requirements for Usable Cannabis
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Sampling Requirements for Extracts, Concentrates, and Infused Products
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Some Sampling Requirements May Be Waived After Successful Completion of a Control Study (See Below)
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Review of New Potency Restrictions
After October 1st, products being testing for regulatory compliance with OAR 333-007 will fail for potency if:
From OAR 333-007:
"(2) A process lot of a cannabinoid concentrate, extract or product that has not successfully completed process validation 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 as specified in OAR 333-007-0200 to 333- 007-0220, as applicable"
Use the links below to learn more about the designated potency limits for different types of Cannabis products.
- the THC value is greater than the limits detailed in the administrative rule
- the primary sample and field duplicate potency values vary by more than 30% relative standard deviation (RSD)
From OAR 333-007:
"(2) A process lot of a cannabinoid concentrate, extract or product that has not successfully completed process validation 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 as specified in OAR 333-007-0200 to 333- 007-0220, as applicable"
Use the links below to learn more about the designated potency limits for different types of Cannabis products.
Retail Cannabis Product Potency Limits
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Medical Cannabis Product Potency Limits
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NOTE:
For medical Cannabis dispensaries participating in early retail sales, OAR 333-008 reads:
"(5) Between June 2 and December 31, 2016 a dispensary may sell:
(a) One unit of a single-serving, low-dose cannabinoid edible to an individual per day. A unit of a low-dose cannabinoid edible can contain more than one edible as long as the total THC in the unit does not exceed 15 milligrams.
(b) One prefilled receptacle of a cannabinoid extract that does not contain more than 1,000 milligrams of THC to an individual per day.
(c) Nonpsychoactive medical cannabinoid products intended to be applied to a person’s skin or hair. "
For medical Cannabis dispensaries participating in early retail sales, OAR 333-008 reads:
"(5) Between June 2 and December 31, 2016 a dispensary may sell:
(a) One unit of a single-serving, low-dose cannabinoid edible to an individual per day. A unit of a low-dose cannabinoid edible can contain more than one edible as long as the total THC in the unit does not exceed 15 milligrams.
(b) One prefilled receptacle of a cannabinoid extract that does not contain more than 1,000 milligrams of THC to an individual per day.
(c) Nonpsychoactive medical cannabinoid products intended to be applied to a person’s skin or hair. "
What are Control Studies?
Feeling overwhelmed by all the new testing and sampling rules? Don't worry! If you are an extract, concentrate, edible, or infused product manufacturer, you can complete a Control Study to receive a certification that allows for only two tests per batch.
Once received, a Control Study certification lasts one year. Control Studies are specific to a particular product, formulation, and manufacturing process. Multiple flavors or colors of products are allowable under one Control Study as long as the potency is not affected.
Once received, a Control Study certification lasts one year. Control Studies are specific to a particular product, formulation, and manufacturing process. Multiple flavors or colors of products are allowable under one Control Study as long as the potency is not affected.
Potency Control Study (Edibles/Infused Products)
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Residual Solvents and Pesticides Control Studies
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What happens if a Control Study passes?
What happens if a Control Study fails?
- The results are submitted to OHA. OHA will grant a control study certification. Once the certification is granted, laboratories may combine sample increments into one primary sample and one field duplicate, resulting in significantly less testing per batch.
- Note that this will result in less testing overall but potentially more sample taken from each batch due to the requirement for a field duplicate.
What happens if a Control Study fails?
- Pesticides/Solvents: If the batch fails for pesticides, it will be reported to OHA and they will arrange the destruction of the batch. If the batch fails for solvents, the batch may be remediated, resampled, and retested.
- Potency: The product may be adjusted to lower the THC concentration to meet prescribed concentration limits. The product may then be resampled and tested.