{"id":1557,"date":"2017-12-20T23:46:10","date_gmt":"2017-12-20T23:46:10","guid":{"rendered":"http:\/\/www.cmtlaboratory.com\/?p=1557"},"modified":"2018-01-26T20:34:13","modified_gmt":"2018-01-26T20:34:13","slug":"medbulletin1709","status":"publish","type":"post","link":"https:\/\/agrisciencelabs.com\/staging\/industry\/medbulletin1709\/","title":{"rendered":"RE: MED Bulletin 17-09"},"content":{"rendered":"

On December 18, the MED issued Industry Bulletin 17-09<\/a>, 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<\/a>. The following is a summary of key points regarding testing that you need to know.<\/p>\n

<\/p>\n

\n

Sample Collection Protocols<\/strong><\/h3>\n

Effective Jan. 1, 2018<\/strong><\/p>\n

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<\/a>.<\/p>\n

\n

Increased Minimum Sample Requirements<\/strong><\/h3>\n

Effective Jan. 1, 2018<\/strong><\/p>\n

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.<\/p>\n\n\n\n\n\n\n\n\n\n\n
Flower\/Concentrate<\/td>\n<\/tr>\n
Flower
\nBatch Size<\/td>\n		Conc. Batch Size<\/td>\nSub-Sample Size<\/td>\nNumber of Sub-Samples<\/td>\nTotal Sample Wt (g)<\/td>\n<\/tr>\n
\u226410 lbs<\/td>\n\u22641 lb<\/td>\n0.5 g<\/td>\n8<\/td>\n\u00a04 g<\/td>\n<\/tr>\n
10-19.99 lbs<\/td>\n1-2 lbs<\/td>\n12<\/td>\n6 g<\/td>\n<\/tr>\n
20-29.99 lbs<\/td>\n2-3 lbs<\/td>\n15<\/td>\n7.5 g<\/td>\n<\/tr>\n
30-39.99 lbs<\/td>\n3-4 lbs<\/td>\n18<\/td>\n9 g<\/td>\n<\/tr>\n
40-99.99 lbs<\/td>\n4-10\u00a0 lbs<\/td>\n23<\/td>\n11.5 g<\/td>\n<\/tr>\n
\u2265100 lbs<\/td>\n\u226510 lbs<\/td>\n29<\/td>\n14.5 g<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n\n\n\n\n\n\n\n\n
Infused Products<\/td>\n<\/tr>\n
Production Batch Size (each)<\/td>\nTest Batch Size (each)<\/td>\n<\/tr>\n
\u2264100<\/td>\n2<\/td>\n<\/tr>\n
101-500<\/td>\n4<\/td>\n<\/tr>\n
501-1000<\/td>\n6<\/td>\n<\/tr>\n
1001-5000<\/td>\n8<\/td>\n<\/tr>\n
5001-10,000<\/td>\n10<\/td>\n<\/tr>\n
>10,000<\/td>\n12<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Multiple tests allowed on each sample<\/strong><\/p>\n

Potency, microbial contaminants and pesticide testing may all be performed on a single test batch with a single Metrc tag.<\/p>\n

Combining harvest or production batches\u00a0<\/strong>prohibited<\/strong><\/p>\n

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\u00a0harvest or production batch.<\/p>\n

\n

Ongoing Testing Following Process Validation (M and R 1501\/1503)<\/strong><\/h3>\n

Effective Jan. 1, 2018<\/strong><\/p>\n

Licensees who have achieved process validation will be required to submit ongoing test samples to maintain their validation as follows:<\/p>\n\n\n\n\n\n\n
<\/td>\nContaminant testing (1501)<\/td>\nPotency\/Homogeneity Testing (1503)<\/td>\n<\/tr>\n
Flower<\/td>\nOne harvest batch every 30 days<\/td>\nOne test for each strain per quarter<\/td>\n<\/tr>\n
Concentrates<\/td>\nProcess validation not available<\/td>\n<\/tr>\n
Infused Products<\/td>\nOnce per quarter for each type of product*<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

* 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.<\/em><\/p>\n

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)).<\/p>\n

\n

Residual Solvents: New Analytes and Lower Reporting Limits<\/h3>\n

Effective Feb. 1, 2018<\/strong><\/p>\n

We will be required to test samples submitted for residual solvents analysis for five additional solvents: acetone, ethanol, isopropyl alcohol, propane and pentane.<\/p>\n

Acceptable limits for residual solvents are being lowered as shown here:<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Solvent<\/td>\nNew Limits (ppm)<\/td>\nCurrent Limits (ppm)<\/td>\n<\/tr>\n
Acetone<\/td>\n<1000<\/td>\nN\/A<\/td>\n<\/tr>\n
Butanes<\/td>\n<5000<\/td>\n<\/tr>\n
Ethanol<\/td>\nN\/A<\/td>\n<\/tr>\n
Heptanes<\/td>\n<5000<\/td>\n<\/tr>\n
Isopropyl alcohol<\/td>\nN\/A<\/td>\n<\/tr>\n
Propane<\/td>\nN\/A<\/td>\n<\/tr>\n
Pentane<\/td>\nN\/A<\/td>\n<\/tr>\n
Benzene<\/td>\n<2<\/td>\n<2<\/td>\n<\/tr>\n
Toluene<\/td>\n<180<\/td>\n<890<\/td>\n<\/tr>\n
Hexane<\/td>\n<60<\/td>\n<290<\/td>\n<\/tr>\n
Total Xylenes<\/td>\n<430<\/td>\n<2170<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Impact on Process Validation<\/strong><\/p>\n

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.<\/p>\n

\n

Medical Products: New Testing Requirements<\/h3>\n

Effective Feb. 1, 2018<\/strong><\/p>\n

Microbial and residual solvent contaminants will become mandatory for medical products.<\/p>\n