By Keith Mansur
Oregon Cannabis Connection
December 4, 2016 — Oregon’s Revised marijuana testing rules are worse than previous ones says Hovering LaPlante, the CEO of Elbe’s Edibles. The revised testing rules released by the Oregon Health Authority, the agency in charge of the state’s cannabis testing regulations, were intended to “lower costs and create a more efficient process,” according to a memo they released on Friday, December 2nd, but it has actually made the regulations worse, according an open letter penned by Hovering LaPlante.
LaPlante is the CEO of Elbe’s Edibles, and he wrote and sent the letter to the Oregon Health Authority, Oregon Liquor Control Commission, and media outlets “actively seeking immediate changes to these temporary rules that only serve to cripple the edible industry.” Under the new “friendlier” testing rules, they have made changes, LaPlante says make it even more difficult and expensive for edibles manufacturers, not easier as the rules intended.
“Previous to 12/2/16, batch sizes were not capped and a batch of 3,200 units (Elbe’s batch size) required 13 samples to be taken. Now, under these new rules, that same batch of 3,200 units will require 39+ samples to be taken,” LaPlante explains in his letter (see below).
They also changed the requirements for process validation, hoping to defer costs of certification which can be expensive and time consuming already.
“It still does not address looking at the underlying process where product homogeneity is actually achieved in a meaningful way, and is now only valid for one year, instead of two,” LaPlante explained about the changes.
LaPlante also decried their “Management-by-memo” practices stating, “Sending out rules that are effective immediately is not friendly to business of any size, and this practice needs to stop.”
Hovering LaPlante’s Open Letter:
To: Governor Brown’s office, OHA, OLCC and interested parties.
Regarding temporary testing rules, effective December 2nd, 2016.
We have been patiently waiting for an adjustment to the testing rules put in place Oct. 1st, 2016. We have been hopeful that changes would be positive and offer relief from the extreme sample collection and testing fee’s that have nearly destroyed the emerging cannabis market in Oregon. The emergency temporary rules released and effective today, Dec. 2nd, 2016 are worse than we could have imagined.
These rule changes do not achieve the stated goal of reducing the testing burden for edible manufactures, in fact, they do the opposite.
Two major issues in these temporary rules:
– Capping edible batch sizes at 1,000 is unnecessary, unreasonable and does not serve the public health in any way. It DOES serve the labs. We’ve noted before that we believe other voices deserve to be heard when writing the testing rules, not only the “lab experts.” It is clear that edible manufacturers sensible recommendations since Oct.1st were ignored before making this change. Previous to 12/2/16, batch sizes were not capped and a batch of 3,200 units (elbe’s batch size) required 13 samples to be taken. Now, under these new rules, that same batch of 3,200 units will require 39+ samples to be taken. How is that meant to be helpful or reduce our burden? It does exactly the opposite. Who put this cap in place and why? We want to know.
– Process validation has now become a Control Study. However, we fail to see how this change benefits anyone. It still does not address looking at the underlying process where product homogeneity is actually achieved in a meaningful way, and is now only valid for one year, instead of two. Clearly this is not a positive change for manufactures. Also, in combination the 1,000 batch size cap – a control study is LESS beneficial than Process Validation was in the previous rule text.
Wasn’t the intention of these rules to lessen the burden?
And finally, sending out rules that are effective immediately is NOT friendly to business of any size, and this practice needs to stop.
We are actively seeking immediate changes to these temporary rules that only serve to cripple the edible industry.
Your prompt attention is needed.
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