On December 18, the MED issued Industry Bulletin 17-09, providing guidance on implementation of new testing regulations going into effect on January 1, 2018. There are several changes that will significantly impact the testing process. We would like to provide you with the most up to date information we have to help you understand how these regulations may affect your business. You may review the new regulations for yourself here. The following is a summary of key points regarding testing that you need to know.
Sample Collection Protocols
Effective Jan. 1, 2018
Licensees will be required to follow specific procedures for test sample collection. The CDPHE will make those procedures available to the public by Dec. 27th, 2017. You will be able to access them through the CPDHE website here.
Increased Minimum Sample Requirements
Effective Jan. 1, 2018
Section 1504 mandates minimum sample requirements based on batch size as shown in the table below. Under the new rules, you will be required to collect several sub-samples and combine them to create on test batch. These requirements are intended to ensure that the sample we test is large enough to be statistically representative of the entire production or harvest batch.
| Flower/Concentrate | ||||
| Flower Batch Size |
Conc. Batch Size | Sub-Sample Size | Number of Sub-Samples | Total Sample Wt (g) |
| ≤10 lbs | ≤1 lb | 0.5 g | 8 | 4 g |
| 10-19.99 lbs | 1-2 lbs | 12 | 6 g | |
| 20-29.99 lbs | 2-3 lbs | 15 | 7.5 g | |
| 30-39.99 lbs | 3-4 lbs | 18 | 9 g | |
| 40-99.99 lbs | 4-10 lbs | 23 | 11.5 g | |
| ≥100 lbs | ≥10 lbs | 29 | 14.5 g | |
| Infused Products | |
| Production Batch Size (each) | Test Batch Size (each) |
| ≤100 | 2 |
| 101-500 | 4 |
| 501-1000 | 6 |
| 1001-5000 | 8 |
| 5001-10,000 | 10 |
| >10,000 | 12 |
Multiple tests allowed on each sample
Potency, microbial contaminants and pesticide testing may all be performed on a single test batch with a single Metrc tag.
Combining harvest or production batches prohibited
Harvest batches and production batches can no longer be combined. The minimum number of sub-samples shown in the table above shall be collected and submitted together on a single Metrc tag for each harvest or production batch.
Ongoing Testing Following Process Validation (M and R 1501/1503)
Effective Jan. 1, 2018
Licensees who have achieved process validation will be required to submit ongoing test samples to maintain their validation as follows:
| Contaminant testing (1501) | Potency/Homogeneity Testing (1503) | |
| Flower | One harvest batch every 30 days | One test for each strain per quarter |
| Concentrates | Process validation not available | |
| Infused Products | Once per quarter for each type of product* |
* MED has verbally clarified that two products are different types if they have different ingredients. For example, two lollipops with differing only in flavor are considered different types.
If any ongoing test sample fails, three additional samples must be submitted for testing, and all three must pass to maintain process validation status. (M/R 1501/1503 (F)(2)).
Residual Solvents: New Analytes and Lower Reporting Limits
Effective Feb. 1, 2018
We will be required to test samples submitted for residual solvents analysis for five additional solvents: acetone, ethanol, isopropyl alcohol, propane and pentane.
Acceptable limits for residual solvents are being lowered as shown here:
| Solvent | New Limits (ppm) | Current Limits (ppm) |
| Acetone | <1000 | N/A |
| Butanes | <5000 | |
| Ethanol | N/A | |
| Heptanes | <5000 | |
| Isopropyl alcohol | N/A | |
| Propane | N/A | |
| Pentane | N/A | |
| Benzene | <2 | <2 |
| Toluene | <180 | <890 |
| Hexane | <60 | <290 |
| Total Xylenes | <430 | <2170 |
Impact on Process Validation
Unless these new limits require substantive changes to your SOPs, you will only need to submit and pass your first three production batches under these new limits in order to maintain process validation.
Medical Products: New Testing Requirements
Effective Feb. 1, 2018
Microbial and residual solvent contaminants will become mandatory for medical products.
- This applies to all medical marijuana optional premises cultivations and medical marijuana-infused product manufacturers. Refer to M 1501(C)(1) and (C)(3) for details.
- This applies to all harvest or production batches created on or after Feb. 1.
Pesticides and Mycotoxin Testing
According to the MED, “Requirements for Pesticide testing and mycotoxin contaminant testing in the Medical and Retail Marijuana Rules will not be implemented until proficiency testing is established and Medical and Retail Marijuana Testing Facilities are certified at sufficient capacity.”
This doesn’t really tell you much other than it’s coming. Exactly when is the “$64k question”, but here’s what we know now:
Pesticides
- One round of proficiency testing for pesticides testing in flower has been performed. The state offered testing facilities the option of two different commercial providers for pesticides proficiency testing. AgriScience Labs elected to take both tests and passed both with 100% accuracy. Moreover, we passed proficiency testing at both our locations (Denver and Western Slope).
- CDPHE issued audit checklists, which provide guidance for for labs seeking certification, on December 13, 2017. This action allows labs to begin submitting applications for certification to CDPHE.
- While several labs have indicated their intent to seek certification, it is currently unknown if a sufficient capacity will be supported by those who were able to pass proficiency tests.
When pesticide testing does begin, expect initial testing on flower only. Proficiency testing in concentrates is yet to be performed and an estimated timeline on that has not been proposed by MED or CDPHE.
Mycotoxins Testing (Remediated Products)
- The new regulations provide requirements for mycotoxin testing in remediated products*. Mycotoxins are highly toxic chemicals produced by certain kinds of mold. While the process of remediation will kill the microorganisms, it does not necessarily remove the mycotoxins.
- Currently, no proficiency testing has been performed for mycotoxin testing and no timeline has been proposed by CDPHE for proficiency testing to begin.
- CDPHE audit checklists for labs seeking certification in this type of test were issued on December 13, 2017.
*Remediated product = solvent-based concentrates made from flower that failed microbial contaminant testing.
Happy to help
If you still have any questions or concerns, feel free to reach us at 303-292-3800 or info@agrisciencelabs.com.
We’ll also be going over the rules in more detail at our Open House on January 18, 2017. RSVP here.