New ODC guidelines align industrial hemp and medicinal cannabis industries
In one of my old blogs, Cultivation of Medicinal Cannabis vs Hemp, I highlighted the differences between the industrial hemp and medicinal cannabis industries – in particular, the fact that there was little-to-no crossover between the two (other than industrial hemp businesses being able to supply seeds to the medicinal cannabis industry).
However, Professor John Skerritt has recently announced during the Australian Medicinal Cannabis Conference 2020, that the ODC have updated their security guidance and it affects both the industrial hemp and medicinal cannabis industries in a radically improved way. (As an aside, while everyone has been making a lot of noise about the interim decision to down-schedule low-dose CBD, I am far more excited about this!)
The main thing I have clamoured for in the past has always been consistency – it didn’t make sense to me that the same starting material (in this case, low-THC strains) should require such vastly different security arrangements depending on the industry.
For example, in a hidden page on the ODC website, the old requirements for low-THC strains grown under medicinal cannabis licences required the following:
This was from an old page that is now archived, and the updated content has been combined into the main Guideline: Security of Medicinal Cannabis, and reflects the following:
Main takeaways from the updated guidance that hemp cultivators need to factor in immediately:
- Hemp crops may be processed for BOTH flower and fibre as long as both an ODC medicinal cannabis licence and a state/territory industrial hemp licence is held. (Bear in mind you must declare the intended medicinal cannabis activities in advance on the ODC licence application. You can also use your current hemp licence and compliance history in support of your ODC licence application.)
- State/Territory security requirements for industrial hemp have been incorporated into the ODC security requirements for hemp crops. (ODC have also provided a very useful table with links to each State/Territory’s industrial hemp legislation in Annex B.)
- Hemp is now included under the medicinal cannabis bracket, thus the term “hemp” can now be used refer to low-THC strains in general (either cultivated for industrial or medicinal cannabis purposes, or both) instead of the old definition of hemp being purely “low-THC strains grown under industrial hemp licences for seed, hurd and fibre.”
What are the immediate benefits of this hemp and medicinal cannabis alignment?
- Start-up costs will now be much lower for hemp-focussed organisations (namely due to lowered security requirements) thus making it much more affordable for small businesses to get involved.
- Increased alignment between federal and state legislation now reduces confusion between the two. Any clarifications which are missing in the ODC legislation are now covered by the specific state and territory requirements for hemp.
3 pitfalls to watch out for when pivoting your industrial hemp business to incorporate medicinal cannabis:
- If you suddenly want to change from cultivating low-THC to both low and high-THC crops, this is considered a major licence variation and will require a step up in security (and evidence) to support this.
- Even though you are cultivating hemp, remember that cannabis plant material still falls under S8 (until CBD is extracted and then falls under S4 – I tried to weasel my way around this, but what is specified in the Poisons Standard as “preparations” does not seem to include the plant in its original form).
(As an aside, if someone wants to propose another amendment to the Poisons Standard to down schedule low-THC cannabis strains grown under medicinal cannabis licences from S8 to S4 please feel free…then everything would align and I would be even happier than I am now.)
- Common farming practices in place for industrial hemp may not be appropriate or align with GACP and other medicinal cannabis requirements, i.e. you can’t treat medicinal hemp like hay.
I have included a handful of examples below.
|Common farming practices||Additional requirements|
|Harvest crop and leave to dry in the paddock||WHO Guide to Good Agricultural and Collection Practices
-Harvested material should be transported immediately to an indoor drying facility to expedite drying so as to prevent any possible deleterious effects.
-Contact with soil should be avoided to the extent possible so as to minimize the microbial load of harvested medicinal plant materials
4.1.2 Primary processing:
-Prior to processing, the medicinal plant materials should be protected from rain, moisture and any other conditions that might cause deterioration.
-Medicinal plant materials should be exposed to direct sunlight only where there is a specific need for this mode of drying
-In the case of natural drying in the open air, medicinal plant materials should be spread out in thin layers on drying frames and stirred or turned frequently.
– In order to secure adequate air circulation, the drying frames should be located at a sufficient height above the ground. Efforts should be made to achieve uniform drying of medicinal plant materials and so avoid mould formation. Drying medicinal plant material directly on bare ground should be avoided.
-If a concrete or cement surface is used, medicinal plant materials should be laid on a tarpaulin or other appropriate cloth or sheeting. Insects, rodents, birds and other pests, and livestock and domestic animals should be kept away from drying sites.
|Bale ground-dried crop||WHO GACP (2.5 Harvest):
Any mechanical damage or compacting of the raw medicinal plant materials, as a consequence, for example, of overfilling or stacking of sacks or bags, that may result in composting or otherwise diminish quality should be avoided.
|Bales stacked in open barn (and any sieved material stored in a metal silo)||WHO GACP (4.1.2 primary processing):
All processed medicinal plant materials should be protected from contamination and decomposition as well as from insects, rodents, birds and other pests, and from livestock and domestic animals.
TGA requirements also come in to play:
TGA requirements for Good Wholesaling Practices for Medicinal Substances in Schedules 2,3,4 and 8.
Section 1: Buildings and Grounds
1.3 The grounds should be established and maintained so as to minimise ingress into the buildings of dust, soil or other contaminants and should be free of accumulated waste, dirt and debris.
1.4 Buildings and storage facilities, including bays, docks and platforms used for the receipt or despatch of goods, should protect the medicines from contamination and deterioration, including protection from excessive local heating, cooling or dampness, or undue exposure to direct sunlight.
1.5 Buildings should be kept free of rodents, vermin, birds, pets and pests, and records should be kept relating to pest control measures.
Section 2 Storage Facilities
2.1 Storage facilities for medicines should protect the medicines from deterioration. The conditions of storage should be in accordance with the storage conditions specified on their labels and their Material Safety Data Sheets (MSDS) where relevant.
2.2 Temperatures in facilities where TSM are held should be monitored using suitable temperature recording devices and the results recorded and analysed so as to demonstrate the suitability of these areas for their purposes. Such records should be kept for at least one year.
2.3 Facilities need to be provided that allow for temperature monitoring and recording in case of power failures.
Section 4 – Stock handling and stock control
4.2 Medicines should be stored off the floor (e.g. on pallets or shelves) to reduce exposure to dust and moisture, and to help facilitate cleaning. Particular care should be taken to prevent mould growth in refrigerated rooms and cabinets.
|Rough estimate of stock taken at end of harvest.||ODC guidance for record-keeping:
-details of cultivation area
-number of plants cultivated
-drying mechanism and average weight loss (where drying is conducted)
-wet and dry weight of crops produced (total)
-wet and dry weight of crops produced (components)
-end of year stock levels of crops produced (wet and dry weight)
-transactions of cannabis along the supply chain (including sale or physical movements)
-forecast production for the next calendar year
-forecast end of year stock for the next calendar year
If you are going to transition from an industrial grow to incorporate a medicinal grow, it is a good idea to review the GACP guide to make sure you have incorporated the other requirements. My blog on the differences between GACP and GMP also highlights some of these details.
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