Oregon’s cannabis testing regulations that began last October 1st have certainly disrupted the market, with many small businesses, consumers and patients feeling the pinch. While these new rules made Oregon’s cannabis “safer than food,” many businesses were starting to lay-off workers and contemplating closing shop.
A report from BDS Analytics revealed an 8.5% decrease in retail sales in October, after month-to-month growth. A further reduction in sales was to be expected if the state didn’t address the issue. The Oregon Health Authority, the state agency ultimately in charge of the testing rules, made some regulatory changes a week ago, but these changes didn’t go far enough to alleviate major issues. Responding to the needs of the burgeoning industry, OHA announced new rules today.
We shall see if these new rules go far enough to protect the nascent cannabis industry. The Oregon Legislature will certainly look at the issue during the 2017 legislative session and OHA will further study the testing issue and make permanent rules next year as well. There have been ups and downs for the Oregon cannabis industry since regulated sales began. Hopefully, the state will soon find the right regulatory balance that will adequately serve patients, consumers and the public, while allowing Oregon mom-and-pops thrive.
Today’s update from the OHA:
December 14, 2016
MEDICAL MARIJUANA INFORMATION BULLETIN 2016-31
Subject: Summary and Guidance for New Temporary Testing Rules
Recently, the Oregon Health Authority (OHA) adopted temporary testing rules with the intention of relieving some of the testing burden on producers and processors. Based on concerns and input from processors that the temporary testing rules adopted on December 2, 2016, were still overly burdensome, the OHA has now adopted additional temporary testing rules to address some of the concerns of stakeholders.
These rules are effective December 15, 2016, and will be valid until May 30, 2017. The temporary testing rules were not intended to overhaul the testing requirements. The intent of the temporary testing rules is to relieve some of the regulatory burden and facilitate the availability of marijuana items to the retail market and to patients. OHA will begin working on a more comprehensive review of the testing rules in the beginning of 2017.
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 changes to the testing rules made effective December 15, 2016, and some general guidance on the testing rules.
The full rule text should be reviewed and may be found at: healthoregon.org/ommprules
Temporary Testing Rule Changes Effective December 15, 2016
OAR 333-007-0350: Batch Requirements
- Cannabinoid products must be separated into process lots of not larger than 35,000 unit batches, up from 1,000 unit batches.
OAR 333-007-0360: Sampling and Sample Size
OAR 333-007-0440: Control Study
- Samples from batches of usable marijuana of the same strain may be combined for purposes of testing potency regardless of the combined total weight of the multiple batches.
- The sample increments required to be collected for cannabinoid concentrates, extracts and products depending on the process lot size have been amended in Exhibit B, Tables 5 and 6.
- The sample increments required to be collected for cannabinoid concentrates, extracts, and products that have successfully passed a control study have been amended and can be found in Exhibit B, Tables 7 and 8.
OAR 333-064-0110: Reporting Marijuana Test Results
- Laboratories have until January 31, 2017, to report certain quality control information on test report results.
General Guidance on Testing Rule Changes
Below is some general guidance for the transition between the old and new testing rules.
- A processor that received certification approval from OHA for process validation for a particular product may still have their certification valid for two years if:
(a) No changes to the standard operating procedures for that product have occurred.
(b) No changes in the type of ingredient in the product, except for a difference in the strain of usable marijuana, or the purity of an ingredient have occurred.
- Laboratories should use sampling increments found in Exhibit B, Tables 7 or 8, for subsequent testing lots for processors that have received certification approval from OHA for process validation. Future sampling of batches should be performed as outlined in OAR 333-007-0440(9).If a change listed above has occurred, the process validation is considered invalid and the processor must follow requirements to complete a control study if they would like.
- Any processor that completed one round of process validation may use the test results as a control study and submit the required documentation to OHA or OLCC, as appropriate. See the marijuana testing page for more information. healthoregon.org/
- For tests performed after October 1, 2016, if a processor only failed a solvent test due to exceeding action levels for Butanol, Propanol, or Ethanol, that test result may be submitted to OHA for review and if approved, the test results may be used and the product may be transferred.
- The process lot size used in the control study defines the lot size that a processor must use for that product for one year.
Again, this is just a summary of the rule changes. The full rule text should be reviewed and may be found at: healthoregon.org/ommprules
For an updated full summary of the temporary testing rules please review Bulletin 2016-30.