1. 2018 Testing Regulations Effective January 1st, 2018
©2018 AgriScience Labs

2. New Required Sampling Protocols
“Amendments to Rules M and R 1504(A)(1) require Licensees to follow specific Sample collection protocols when submitting Test Batches for testing pursuant to Medical and Retail Marijuana Rules M and R 1501, 1503, and ”
Issued on 12/27/17 (not a lot of time to adapt!)
Separate sampling protocols for Flower, Concentrates, and Edibles issued by the CDPHE.
Protocols can be found here:

3. General Sampling Procedures
Testing required to be conducted on each flower harvest batch.
Multiple harvests may no longer be combined into one batch for testing.
Samplers can be either internal or an authorized third party.
Sampling documents must be maintained that include all required information listed in the SOP. These are internal documents and should be maintained like any other required document.
A witness (different from the individual sampling) must initial the manifest to indicate they have reviewed the labels and samples and that they are accurate.
The purpose of these procedures is to produce samples that are representative and unadulterated.

4. General Sampling Procedures
Each sample collection event (ie, submission for testing) should have an associated sample collection plan.
This document includes information detailing the product collected, the individuals and businesses involved, and the procedures followed.
These are internal documents and should be maintained following established record retention SOPs.
A sample collection plan is included as an appendix in each CDHPE SOP.
It is important that samples are collected using the correct equipment (such as disposable gloves, isopropyl alcohol, and clean containers) that has been cleaned and sterilized according to the SOPs. This helps to reduce the chances of cross-contamination.

5. General Sampling Procedures
Samples should be collected (and submitted) in the final, ready-for sale form.
This means that flower meant for consumer sale should be dried & cured, in the same state the customer would receive it. Fresh frozen material for live resin should similarly be fresh frozen material, as it is delivered to a MIP for processing.
Edibles, topicals, and other infused products should be in the same final packaging that it would be on the shelf at a store, with the exception of the final potency statement and associated labels, as this may not be generated until after testing.
The number of servings in each test sample unit should be identical to the number of servings in the consumer package.
Multiple “sub-samples” are collected following CDPHE SOPs to be representative of the batch. Collection protocols vary by product and storage; refer to SOPs for location and randomization information.

6. Production Batch Size (each)
Sample Sizes
Flower/Concentrate
Infused Products
Flower
Batch Size
Conc.
Sub-Sample Size
Number of Sub-Samples
Total Sample Wt (g)
Production Batch Size (each)
Test Batch Size (each)
≤10 lbs.
≤1 lb.
0.5 g 8
4 g
≤100 2
10 – lbs.
1 – 1.99 lbs. 12
6 g
101 – 500 4
20 – lbs.
2 – 2.99 lbs. 15
7.5 g
501 – 1,000 6
30 –39.99 lbs.
3 – 3.99 lbs. 18
9 g
1,001 – 5,000
40 – lbs.
4 – 9.99 lbs 23
11.5 g
5,001 – 10,000 10
≥100 lbs.
≥10 lbs. 29
14.5 g
>10,000

7. Process Validation
Ongoing testing is now required to maintain process validation (once achieved):
Contaminant Testing (1501)
Potency/Homogeneity Testing (1503)
Flower
One harvest batch every 30 days
One test for each strain per quarter
Concentrate
One production batch every 30 days
Process validation not available
Infused Products
Once per quarter for each type of product
If any ongoing test sample fails, and also fails the retest, then three additional samples must be submitted and pass testing to maintain process validation.

8. Residual Solvents: New Analytes and Lower Reporting Limits
Effective February 1, 2018
We will be required to test samples submitted for residual solvent analysis for five additional solvents: acetone, ethanol, isopropyl alcohol, propane, and pentane.
If new limits make material changes to SOPs, will need to start over process validation.
If no material change, then re-validation will require passing tests on first three production batches under new limits. (Per MED Bulletin 17-09)
Solvent
New Limits (ppm)
Current Limits (ppm)
Acetone
<1,000
N/A
Butanes
<5,000
Ethanol
Heptanes
Isopropyl alcohol
Propane
Benzene
<2
Toluene
<180
<890
Pentane
Hexane
<60
<290
Total Xylenes
<430
<2,170

9. Medical Productions: New Testing Required
Effective February 1st, 2018
Microbial and residual solvent (contaminant) testing becomes mandatory for medical flower, concentrates, and infused products.
Applies to all medical marijuana optional premises cultivations and medical marijuana-infused product manufacturers. Refer to M 1501(C)(1) for details.
Applicable to all harvest or production batches created on or after Feb 1, 2018.

10. Pesticide and Mycotoxin Testing
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 testing facilities are certified at sufficient capacity.
Currently, we do NOT know when this is scheduled to start.

11. What we do know: Pesticides:
One round of proficiency testing in flower has been performed. AgriScience Labs has passed with 100% accuracy at both locations (Denver and Western Slope).
CDPHE issued audit checklists allowing for labs to submit applications for pesticide certification.
It is currently unknown what the industry capacity is for pesticide testing.
Expect initial testing on flower only (based upon proficiency testing completed).

12. Mycotoxin Testing of Remediated Products
The new regulations provide requirements for mycotoxin testing of remediated products. Mycotoxins are highly toxic chemicals produced by certain kinds of mold. While the process of remediation will kill live 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 in December.

13. METRC Updates Testing Functionality now added!
Requested testing MUST be selected prior to submitting to lab. Failure to do so may result in delays on results and need to open metrc tickets.
Homogeneity is “potency”
TYM retests fall under “Microbial”

14. FAQ
Is the batch weight for determining the number of sub-samples based upon wet or dry weight?
This should be based upon the weight of the harvest at the time of testing.
Are we required to purchase Whirl-pak bags?
The sampling SOPs state that Whirl-pak bags, 40mL VOA vials, or equivalent are acceptable. We have interpreted this to mean that zip lock bags are still acceptable, provided the entire sample fits within the bag. Care should be taken to only use new or sterile containers. The VOA vials are the preferred choice for concentrates (glass is better than plastic).
Do we have to use a cooler for transporting samples?
The CDPHE Sampling SOPs do indicate that samples should be stored in a cooler with ice at a temperature right around 40 degrees F. While we are still awaiting some clarification on the MED on this point, ASL is currently planning on using coolers and ice packs for transport.

15. FAQ
If I’m already process validated, does my process validation start over??
There is no indication that your previous process validation is removed by the new regulations, though in order to maintain that process validation, you will need to submit samples more frequently. This has been detailed above.
What determines a different “type” of infused product for process validation on going testing?
The MED has verbally clarified that two different products are different types if they have different ingredients. For example, two lollipops with different flavors would be two different types.
Can we still combine multiple harvests into a single test batch?
No, this is no longer allowed.

16. FAQ
I see there is a sampling protocol for edibles, but is there one issued for non-edible infused products such as topicals and suppositories?
Currently there is not an SOP for this from the CDPHE. We have requested additional information on this.
What do I do if the sampling spreadsheet tells me to sample from the same location twice?
The SOPs clarify that you should select a different plant from that same area.
What tests are requested in Metrc for R&D testing, such as R&D potency or terpene testing?
For terpenes or other non-required testing, please write the test requested on the tag.
If you are doing R&D testing that is also state-mandated, select the appropriate test, but make sure that your ITEM NAME clearly states R&D in the field.

17. ASL Sample Sizes Guide https://agrisciencelabs. us15. list-manage

18. ASL Sample Sizes Guide https://agrisciencelabs. us15. list-manage

19. ASL Sample Sizes Guide https://agrisciencelabs. us15. list-manage