project CBD critiques new quality regulations

[bentech]

Safety requirements
Allowable limits for contaminants including pesticides, solvents, and microbes are described in sections 5718-5723 of the new regulations. These regulations have fixed a major issue in the initial draft where two different units were confused – parts per million by weight (µg/g) and parts per million by volume. Now solvent and pesticide limits are given in µg/g.
Other significant changes:
Solvent limits are largely improved. Certain class 2 solvents have been banned, as Project CBD had previously suggested.
Pesticide limits have swung from being very strict to being overly lax. The environmental concerns related to pesticide overuse appear more problematic than the health effects for consumers.
Many pesticide safety limits are still based on regulations for tobacco, which is entirely inappropriate.
Required tests for microbial contamination are minimal.
Limits on mold – one of the most common contaminants of cannabis – are nearly nonexistent. A product is deemed to pass regulations if less than 1/4th of it is covered in mold

Solvents - §5718
Solvents are broken into two categories for the purpose of regulations. Category 1 solvents are banned and are not permissible at any detectable levels in cannabis products. Category 2 solvents are allowed up to set action limits that depend on the solvent in question and whether the product is inhaled or not. Action limits for non-inhaled products were appropriate in the initial draft proposal and have not changed.
The initial proposed regulations allowed for the use of highly dangerous solvents, including benzene, which Project CBD suggested be banned from use in cannabis manufacturing. We also suggested that regulators consider banning “class 2” solvents such as chloroform, since they are unnecessary for producing most kinds of cannabis extracts.1 The new regulations now ban the use of benzene and some class 2 solvents like chloroform, but allow other class 2 solvents, including hexane. (Hexane is rarely used to extract oil from cannabis, but is sometimes used to clean the oil of pesticides or other adulterants.) Although Project CBD hopes that cannabis manufacturers avoid using hexane to extract or clean oil, we believe these regulations are appropriate.
Each permissible solvent has a maximum allowable concentration in inhaled cannabis products (e.g. vape cartridges). In the initial draft proposal, these limits were based on safety data from California’s Occupational Health and Safety Administration (OSHA), although the limits were improperly calculated due to confusion with units. (“Parts per million” can have multiple meanings, as mentioned above. See the previous Project CBD statement for more detail.) The new limits are particularly stringent for some class 2 solvents and are overly lenient for ethanol residues.2   On the whole, the new limits are sensible.
Pesticides - §5719
Similar to solvents, pesticides are broken into banned pesticides, which are not allowed at any detectable concentration, and allowed pesticides. The action limits for permitted pesticides depend on whether the product is inhaled or not.
The regulations were released with only 5 days for public comments – including the weekend – and were not accompanied by any statement of reasons explaining how new safety limits were determined. As such, Project CBD’s comments on the new pesticide regulations point out potential problems without necessarily suggesting how these issues could be fixed or their extent.
In the new regulations, the list of banned pesticides has shrunk dramatically, from 42 to 21. One of these now-allowed pesticides is a neonicotinoid (acetamiprid) and four others have “high acute toxicity” to humans, according to the initial statement of reasons (bifenthrin, cyfluthrin, naled, and abamectin). Most of the rest of the now-allowed pesticides were banned in the original proposal due to environmental concerns, including myclobutanil (often sold Eagle-20).

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The initial set of draft regulations on pesticides were very strict in some regards. The limit of detection (LOD) – which is the lowest concentration of a compound that can be detected reliably – was arbitrarily set at 0.01 – 0.02 µg/g. This is lower than the actual LOD of pesticides in cannabis for most labs. This has changed – now labs will determine their LODs scientifically and list these LODs on lab reports.3 This is an important fix.
To reiterate: because no statement of reasons has been released, we do not know the rationale behind the limits for pesticides on non-inhaled products. But we can say with some certainty that it is not based on the relative safety of these pesticides.


The outcomes of the tobacco industry’s war against science should never be used as the basis of safety regulations for another industry. Tobacco is the leading cause of preventable deaths in the United States, killing roughly half a million people every year. This is precisely because the tobacco industry lobbied to ensure that scientific data on health and safety was not used to inform laws or regulations. That should not be the starting point for any aspect of the emerging cannabis industry.



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