MEDICAL MARIJUANA INFORMATION BULLETIN 2017-05 UPDATED
Subject: Summary of Division 7 Rule Changes Effective May 31, 2017
OHA has updated the cannabis testing rules aimed at balancing the need for ensuring a reasonably safe product for patients and consumers, protecting public health, and the cost to producers and processors.
Testing is still required to be performed by an accredited and licensed laboratory. Testing rules apply to both medical and retail marijuana items.
Below is a summary of the rule changes to division 7 regarding labeling and testing. The full rule text should be reviewed and may be found at: healthoregon.org/ommprules
Definitions: OAR 333-007-0310
The definition of “harvest lot” now means “a specifically identified quantity of marijuana that is cultivated utilizing the same growing practices, harvested within a 72-hour period at the same location and cured under uniform conditions.” A harvest lot may contain multiple strains.
Ordering Test: OAR 333-007-0315
Outlines the minimum information required to be provided to the laboratory prior to sampling, which includes:
- Producer or/ processor’s registrant or license number.
- Name, address and contact information of the registrant or licensee.
- Type of marijuana product.
- Harvest lot or process lot number that is associated with the batch number of batches to be sampled.
- Number of batches to be sampled.
- Total mass or volume of each batch to be sampled.
- For cannabinoid products, the unit of sale.
- Identification of the test(s) being requested.
- Whether the test(s) being requested are compliance, quality control, or research and development test(s).
- If a batch is being re sampled due to a failed test, specifying the date the failed result was received by the registrant or licensee and laboratory identification number of the laboratory that conducted the initial test.
- Whether the marijuana item has a certified control study.
Compliance Test Required for Marijuana Items or Usable Marijuana: OAR 333-007-0320
- Every batch from a harvest lot of useable marijuana must be tested for pesticides, water activity and moisture content, and potency before being transferred to a processor, processing sited, dispensary or retail shop.
An exception for this is made in 333-007-2000, where OLCC may establish the frequency of pesticide testing required by a producer or wholesaler as long as at least on third of the batches in a harvest lot are tested for pesticide. This exception doesn’t apply to medical marijuana growers.
Compliance Testing Requirements for Cannabinoid Concentrates and Extracts: OAR 333-007-0330
This rule requires every process lot of cannabinoid concentrates or extracts must be tested for pesticides, solvents and potency before being transferred.
Batch Requirements: OAR 333-007-0350
- The size of a batch in a harvest lot was increased from 10 lbs to 15 lbs.
- Cannabinoid products must be separated into process lots of not larger than 35,000 unit batches.
- The size of a process lot of concentrates, extracts or products submitted for sampling and testing for purposes of a control study defines the maximum process lot size for future batch sampling and testing for that item if the control study is certified.
Sampling and Sample Size Requirements for Compliance Testing: OAR 333-007-0360
- Samples of different batches of the same harvest lot of usable marijuana may be combined for purposes of testing for potency if the batches are the same strain.
- Samples of different batches of usable marijuana may NOT be combined for purposes of pesticide testing. OAR 333-007-0320 outlines every batch from a harvest lot marijuana must be tested for pesticides.
- Minimum sample increments for different batch sizes of units of sale for concentrates, extracts and product can be found in Exhibit B, Table 5 or 6 located on the OMMP website found below.
- Once a concentrate or extract has a certified control study, the minimum number of sample increments are established in Exhibit B, Table 7. Sample increments may be combined into a primary sample and a field duplicate sample but must be prepared and analyzed separately.
- After a cannabinoid product has successfully completed a control study, at a minimum one unit of sale is required for the primary sample and one unit of sale is required for the field duplicate sample for future patches of that product. Both the primary sample and the field duplicate sample must be prepared and analyzed separately, enough product must be sampled for the laboratory to perform all required tests.
Sampling Personnel Requirements; Sampling Record keeping: OAR 333-007-0370
- If a producer or whole sales transports any marijuana product to a laboratory for compliance testing of pesticides all the batches for the harvest lot must be transported so the laboratory can choose which batches to sample from.
Standards for THC and CBD Testing: OAR 333-007-0430
The maximum concentration limit permitted in a package may have a variance of 10 percent over, but no more, as applicable specified in OAR 333-007-0200 to 333-007-0220.
Control Study: OAR 333-007-0440
- If a processor chooses to perform a control study, every cannabinoid concentrate, extract or product must successfully complete one control study every year.
- During a control study, sample increments must be tested for compliance separately to determine if the concentrate, extract or product is uniform.
- Once OHA has certified a control study, future sample increments may be combined into a primary sample for testing and a field duplicate sample must be taken.
- If a sample increment from a control study fails it cannot be remediated and resubmitted for a control study.
- A control study will be valid for one year unless a change to the standard operating procedure or a change in the type of ingredient is made by the processor or processing site.
o Products that differ only in flavor or color do not need a separate control study as long as the different flavors or colors do not have an effect on the potency.
Failed Test Samples: OAR 333-007-0450
- If after a failed test a registrant wishes to have a sample reanalyzed, the registrant must request a reanalysis within 7 calendar days from the date the laboratory sent notice of the failed test. The reanalysis must be completed by the laboratory within 30 days from the date the reanalysis was requested. If a primary sample or a field duplicate sample fails, both must be reanalyzed. The laboratory that did the initial test may not subcontract the reanalysis.
- If a registrant requested a reanalysis and the sample passes, the registrant has 7 calendar days from the date the laboratory sent notice of the passed test to request that another laboratory re-sample the batch and confirm the passing test result. The re-testing must be completed by the second laboratory within 30 days from the date the retesting was requested. The registrant needs to follow OHA’s instructions for reporting reanalysis and subsequent testing results.
- If a batch fails pesticide testing, it may not be destroyed without obtaining permission from the Authority.
- If a batch of usable marijuana fails pesticides testing for piperonyl butoxide or pyrethrins only, and the ODA determine that only products from the ODA Guidelist for Pesticides and Cannabis were applied in accordance with the label, the producer or grower may be permitted to remediate the product using procedure that would reduce the concentration of pesticides to less than the action levels. A batch of usable marijuana that is remediated must be re-sampled and re-tested for pesticides.
- If a processor or processing site only uses usable marijuana that has passed pesticide testing and a sample from a batch of concentrates or extracts fails pesticide testing, the batch may be remediated using procedures that reduce the concentration of pesticides to less than the action level. A batch that is remediated and after being re-sampled and re-tested fails pesticide testing, batch must be destroyed by obtaining permission from the Authority or Commission.
Audit and Random Testing: OAR 333-007-0480
A registrant will be required to pay for any audit or random testing if selected. OMMP may obtain marijuana items from a registrant at any time and have it tested to ensure compliance.
Quality Control and Research and Development Testing: OAR 333-007-0500
- A registrant or a licensee may request a laboratory to conduct a test for the purpose of assuring quality control or for research and development.
- A grower or producer may not request a laboratory to conduct a pesticide test on usable marijuana for purposes of quality control or research and development. A pesticide test on usable marijuana is always considered a compliance test for licensee and registrants.
- A laboratory result from a quality control or research and development test cannot be used as a compliance test. Only marijuana items with compliance tests may be transferred and sold.
OLCC Licensee Pesticide Testing Requirements: OAR 333-007-2000
- OLCC may establish the frequency of pesticide testing required by a producer or wholesaler as long as at least one third of the batches in a harvest lot are tested. If any sample taken from a batch fails a pesticide test, every batch from the harvest lot must be tested for pesticides.
- If all samples from each randomly chosen batch of a harvest lot pass pesticide testing, the entire harvest lot is considered to have passed pesticide testing and may be transferred or sold. A laboratory will not be considered in violation of any accreditation standards for reporting these tests as passing.
Reporting Marijuana Test Results: OAR 333-064-0110
- Test reports must clearly indicate whether a sample has failed a test, a pesticide has been detected, include the batch identification number and test batch number associated with the samples tested and indicate if a test is a compliance test or a quality control or research and development test.
- A laboratory’s LOQ must be below the action limits established for pesticides and solvents.
This is just a summary of the rule changes. The full rule text should be reviewed and may be found at: healthoregon.org/ommprules