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Member Blog: The Days Of Breaking Bad Are Over… Sort Of

by Meghan McCormick, Ph.D, Spektrum Cannabis Technologies

With the expanding decriminalization of marijuana and hemp and increasing market demand for cannabis concentrates, more people are assuming the role of pseudo-chemists or lab technicians without formal training. People no longer need to ‘break bad’ by extracting and processing cannabis in their garages, kitchens, or old RVs. Commercial laboratory spaces are becoming more common. Unfortunately, without formal laboratory training, appropriate laboratory safety habits are often not established. The ‘whatever-it-takes’ mentality plus some questionable lab techniques add up to be quite dangerous in a pursuit for the ‘good stuff.’ 

Solvents used for extraction, though often odorous, are clear and colorless and therefore invisible in vapor form. They are often handled in the lab like water. For those manufacturing cannabis concentrates for retail, the focus has been on possible regulations set by the FDA, but these new, small businesses are also under the jurisdiction of OSHA. While studying industrial hygiene standards written by OSHA, most safety practices seem like common sense, but only after the chemical hazards are recognized. 

For more in-depth safety standards and fire codes for non-glassware or non-laboratory-scale (read: industrial-scale) extraction and processing equipment, ANSI/CAN/ UL/ULC 1389 or NFPA 1 Chapter 38 are great starting points. 

Most of What We Breathe Is Invisible

As mentioned above, the solvents used to extract and process cannabis are either gases compressed into their liquid form or clear, colorless organic liquids. [Note: here ‘Organic’ means a substance that contains carbon, not the label you find at your grocery store]. These solvents include ethanol, propane, butane, pentane, hexane, isopropyl alcohol, methanol, acetonitrile, and other less common ones. 

The danger of these solvents is that even when they are cold they vaporize easily enough for inhalation, some without harsh odors as a warning. Opening containers, glassware, or vessels without proper ventilation or PPE (personal protective equipment) exposes laboratory workers over a short time and many times a day. This exposure can occur during simple acts of pouring, transferring, heating, drying, mixing, or weighing on a balance. While many of the solvents used have a GRAS designation (generally regarded as safe) by the FDA, this label is used for food additives with the intention of ingestion, not inhalation. There are a few research studies on the toxicological effects of breathing in these VOCs (volatile organic compounds) in a short period of time. However, chronic studies of consistent exposure for years are rare. NIOSH, or the National Institute for Occupational Safety and Health, provides a decent summary of worker exposure studies for common industrial chemicals. Some of which can cause respiratory effects that evolve into allergies or even neurological damage. Unfortunately, most of the toxicological literature available can be decades old.

Yet laboratory technicians are not the only ones exposing themselves to a potential hazard. Working on large-scale extraction equipment, workers come into contact with large plums of high concentrated VOC when opening extraction tanks and vessels. This process happens many times a day when workers reach in to load and unload bags of cannabis biomass. Exposure also occurs through skin contact, as many of these solvents absorb into uncovered skin.

Gases under pressure are yet another non-chemical hazard. Compressed gas tank cylinders need to be transported and stored safely to keep them from falling over and crushing limbs. If a cylinder valve breaks off, they turn into a projectile missile, or they become damaged enough to rupture and release thousands of liters of suffocating gas within minutes or seconds.

Carbon dioxide solid in the form of ‘dry ice’ is often used in large amounts for cold traps in cannabis oil processing. Dry ice easily sublimes, where the solid form converts directly into a gas. Gaseous carbon dioxide is much heavier than general air and can easily displace oxygen in closed-off storage areas. Oxygen sensors, proper ventilation, and limited exposure help to avoid hazardous side-effects of oxygen deprivation.

The Tools to Keep Everyone Safe Are Out There

Any workplace that handles or stores chemicals should have the corresponding Safety Data Sheets (SDS) of the chemical. These are usually obtained from the manufacturer of the chemical, but there are also free databases online for easy access. All SDS’s should be available for easy access to workers who handle or are in an environment that uses chemicals.

OSHA also provides its own chemical database system that lists the physical properties of chemicals as well as their permissible exposure limits (PELs) and short-term exposure limits (STELs). These limits are used for compliance purposes, but in short, they provide a rough guide for how dangerous it is to breathe in some of these chemicals. Note that OSHA’s exposure limit guidelines may be outdated as many have been written 50 years ago when OSHA had been founded! For the latest guidelines visit NIOSH and ACGIH.  These organizations/agencies keep up with current toxicological research and provide more up-to-date exposure limits that are sometimes significantly lower. Air sampling of your workers can always be done through an AIHA-accredited laboratory that will send out certified industrial hygienist to sample during a work shift.

Any industrial hygienist will tell you that the use of PPE is the last line of defense against chemical hazards and exposure. Engineering controls like proper room ventilation and local ventilation, including fume hoods, exhaust hoods, and elephant hoses, are some of the best ways to avoid exposure through inhalation. Fume hoods are almost always found in laboratory spaces; however, it’s easy to form bad habits when using them. For example, storing large objects and numerous chemical bottles inside the hood significantly blocks the proper airflow that needs to occur to make sure any vapor is properly ventilated. The sash (or glass door) should always be kept as low as possible and especially below the chin of the person working at the hood. Newer models of fume hoods have airflow monitoring devices and alarms systems to make sure the face velocity of the hood is between 80 and 120 fpm (feet/min).

Finally, PPE that fits comfortably, doesn’t interfere with the flow of work, and is rated properly for the hazards of the chemicals used, is a definite requirement when working with chemicals even when other controls are in place. 

When effective local ventilation is not available for situations where a large plume of solvent vapor is expected (e.g., opening an extraction vessel to remove biomass bags), a full-face or half-face respirator is the best option to prevent exposure. 

Respirators have specific cartridges that stop the inhalation of certain hazards. VOC cartridges are required to keep out the organic solvents most used. However, respirators will only protect as they meant to be if they are fit-tested, and properly cleaned and stored. 

Last, eye protection via safety glasses is an obvious and thankfully well-practiced habit even in workplaces without chemicals. Unfortunately, the commonsense practice of making sure workers are wearing long pants, shirts with sleeves or lab coats, and closed-toe shoes (preferably non-absorbent) is more difficult to enforce if the location is in warmer climates.

All that said, for those who are dabbling in the new, exciting world of cannabis extraction, let’s hope they are following Walter White’s lead and suit up before they get to work.

With more than 15 years of experience working and teaching in chemistry laboratories, Meghan McCormick, Ph.D. is the Senior Chemist and a part of the Herban Legends team at Spektrum Cannabis Technologies, an innovative, fit-for-purpose engineering services company. Meghan serves as the resident expert in the chemical processes that occur during cannabis extraction and post-processing and has helped design and test the Spektrum industrial-scale cannabis processing modules. Meghan worked as a Senior Chemist for the OSHA Salt Lake Technical Center for 3 years. She received her Ph.D. in Inorganic Chemistry at Indiana University studying organometallic electrocatalysis and anti-cancer prodrug activation mechanisms.

Committee Blog: California Permanent Regs Roundup

by NCIA’s State Regulations Committee
authored by Juli Crockett, MMLG

As 2018 came to an end, the FINAL proposed text of the permanent regulations for California cannabis were submitted to the Office of Administrative Law (OAL) by the three regulatory agencies – the California Department of Food and Agriculture (CDFA), California Department of Public Health (CDPH), and the Bureau of Cannabis Control (BCC). The cannabis regulations submitted to the OAL are currently undergoing a 30-day administrative review to ensure alignment with MAUCRSA and statutory requirements. These “final’ regulations shall become effective immediately upon approval/adoption which should be on/before January 16th 2019.

What “final” means in this evolutionary process of California cannabis regulations is debatable, as there are already several Assembly and Senate bills queued up to be put through the legislative tango and all three of the regulatory agencies have indicated that there will be further clean-ups and clarifications of the “permanent” regulations. Although there will assuredly be changes ahead, this is a highlight reel of where California Cannabis stands now.  

For those that dug into the October redrafts, much of the substantial changes that occurred in that version carried over into the final proposed text. Here we will highlight the top eight changes impacting cannabis businesses in California.  

The Final Statement of Reasons from the BCC, which also included responses to pertinent comments received during the previous 15- and 45-day comment periods, is where some greater clarity about the regulatory changes and intents can be found. It is by spelunking into these deeper caverns of reasoning where the sweet ore of further clarity can sometimes be extracted.  

Here are 8 highlights for anyone interested in California cannabis.  

1. Ownership and Financially Interested Parties

In October we saw the expansion of the definition of ownership and financially interested parties that clearly sought to capture the identification of any and all warm bodies that stand to direct, control, or financially benefit from commercial cannabis. While there were some changes in sections §5003 and §5004 between the previous and current version, the scope and intent remained the same. One particularly vague line §5003.b.6.D “Any individual who assumes responsibility for the license.” was removed from the BCC’s definition of owner, this very line turned up over the in the CDPH’s update in §40102.a.4.D.  

The Ownership and Financially Interested Parties disclosures dovetail into the White Labeling issues (See #2)  in that “Brand Owners” that may be licensing IP to contract manufacturers have been impacted by the prohibition on non-licensees conducting commercial cannabis business with licensees. In the response to comments in the FSOR was this gem of insight, “In response to commenter’s questions, if a licensee includes as one of their owners a brand-owner, the licensee can produce the branded products because in this case the licensee is not engaged in commercial cannabis activity on behalf of an unlicensed person. Because the owner of the brand is an owner of the licensee, there is no unlicensed person involved.” Of course, before everyone runs off and adds brand-owners as owners of their contract manufacturing business, let’s take a moment to reflect on the value and critical importance of a well-drafted contract.  

2. §5032 (b) The So-Called “White Label Prohibition”  

  • 5032.b shall go down in infamy as one of the more talked-about sections of the BCC’s regulations. This simple sentence, “Licensees shall not conduct commercial cannabis activities on behalf of, at the request of, or pursuant to a contract with any person that is not licensed under the Act,” brought with it a level of confusion and white-hot panic regarding the inferred white label prohibition contained therein. October’s version had more explanatory examples for the types of “on behalf of, at the request of, or pursuant to” activities that the BCC was talking about, such as, “procuring or purchasing cannabis goods from a licensed cultivator or licensed manufacturer. Manufacturing cannabis goods according to the specifications of a non-licensee, Packaging and labeling cannabis goods under a non-licensee’s brand or according to the specifications of a non-licensee, Distributing cannabis goods for a non-licensee.” This language was removed in the final version submitted to the OAL and is one of the examples of where the FSOR is enlightening. 

From the BCC’s FSOR: “Initially, the Bureau determined that it was necessary to assist licensees with determining what types of activities may or may not be allowed under the Act and its implementing regulations. The initial proposed change identified certain transactions that would generally be considered commercial cannabis activities under the Act. However, the Bureau has determined that inclusion of the clarifying example transactions is causing more confusion. Accordingly, the Bureau has decided not to move forward with the proposed changes which identify examples of specific commercial cannabis transactions.” The definition of “commercial cannabis activities,” therefore, is an important one, and we can refresh ourselves on that one (Business and Professions Code §26001.k) “‘Commercial cannabis activity’ includes the cultivation, possession, manufacture, distribution, processing, storing, laboratory testing, packaging, labeling, transportation, delivery or sale of cannabis and cannabis products as provided for in this division.”  

This has been a hot, hot topic, and there have been some great analysis articles of this provision that dig further into solutions and scenarios related to this section. Get thee to Google and find out more!  

3. Option to label THC/CBD post-final testing by Distributor

This was a big win for the industry! A substantial percentage of testing failures for “label claims” are due to products, previously required to be labeled with THC/CBD content prior to final testing (the one test that counts!) not falling within the 10% allowable variance threshold. It’s common knowledge that the science of cannabinoid testing is still getting dialed in, and the labs have some serious challenges in hitting the same tiny target twice. Especially when they are dealing with the vast array of cannabis product matrices, and an industry that it still learning about important things such as homogenization. The good news is, the CDPH now allows products to be labeled for THC/CBD content after that all-important final test, which should eliminate well-upwards of 50% of the product failures in California and ensure a steadier supply chain.  

4. Regulation of Technology Platforms

The cannabis industry has always been a place of innovation and loophole-finding. These regulations are an attempt to close some of those loopholes that seem to have created a situation where unlicensed tech platforms were enjoying the privileges of licensed commercial cannabis without undergoing the slings and arrows of local/state licensure and regulation. Seeing themselves outside of the regulatory purview, certain business claimed that agencies such as the BCC had no dominion over their activities. Well, they may have wanted to wait until the ink dried on the final regs before making such an assertion, as now it seems the BCC has expanded its reach to embrace all kinds of advertising, facilitating, and delivery platforms.  

5. Delivery to a Physical Address

This was (potentially) a huge win for patient access, however, it remains to be seen how this truly shakes out. When the BCC added the line that “a delivery employee may deliver to any jurisdiction within the State of California” it caused some serious outrage from municipalities that have banned commercial cannabis activity, the League of Cities, law enforcement, and others that saw this as a huge overstepping of the local authority ensured by Prop 64 and MAUCRSA. The LOC even launched a “wandering weed” campaign, in response to which it seems that a subsection that includes “a restriction on delivering cannabis goods to a school providing instruction in kindergarten or any grades 1 through 12, day care center, or youth center” was added to the regulations, for clarity. Whether the OAL will approve as is, and how this interacts with local bans, tax requirements, and law enforcement, and lawsuits… stay tuned! While the BPC (§26090.e & 26080.b) explicitly prohibits a local jurisdiction from preventing delivery, and transportation, of cannabis goods on public roads, it does not prevent localities that have banned commercial cannabis in their area from adopting ludicrous tax rates for deliveries that would in effect ban via taxation delivery in their area.  

6. Sale of Non-Cannabis Goods (aka No Hemp)  

While the seeming victory of the Farm Bill has folks leaping with joy for the future of hemp, statements from the FDA and other agencies have certainly rained on the parade of many a CBD vendor. Add to that the collections of California cannabis regulations that in effect eliminate hemp-derived CBD from cannabis dispensaries and products.  

“In addition to cannabis goods, a licensed retailer may sell only cannabis accessories and any licensee’s branded merchandise.” (BCC §5407)

This limitation for retail (and retail delivery) is further clarified in the BCC’s FSOR in their responses to comments:  

“Cannabis retailers are licensed to sell cannabis goods. The definition of cannabis within the Act explicitly excludes industrial hemp products. Industrial hemp is regulated by the California Industrial Hemp Program under the California Industrial Hemp Farming Act.”  

“A retail license from the Bureau authorizes the retailer to sell cannabis goods and cannabis accessories. A retail license from the Bureau does not authorize licensees to sell items that are unrelated to cannabis.”

Combined with the retail prohibition on non-cannabis products, this trifecta from the CDPH extends that prohibition to manufacturers:  

  1. “A manufacturer licensee shall only use cannabinoid concentrates and extracts that are manufactured or processed from cannabis obtained from a licensed cannabis cultivator.” (CDPH §40175.c)
  1. “Except for cannabis, cannabis concentrate, or terpenes, no product ingredient or component shall be used in the manufacture of an edible cannabis product unless that ingredient or component is permitted by the United States Food and Drug Administration for use in food or food manufacturing, as specified in Everything Added to Food in the United States, or is Generally Recognized as Safe (GRAS) under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act.” (CDPH §40305.a)iii. “Except for cannabis, cannabis concentrate, or terpenes, topical cannabis products shall only contain ingredients permitted for cosmetic manufacturing in accordance with Title 21, Code of Federal Regulations, Part 700, subpart B (section 700.11 et seq.) (Rev. March 2016), which is hereby incorporated by reference.” (CDPH §40306.a)


For now, it seems, non-cannabis derived CBD is DOA in CA.  

7. Child Resistant Packaging (CRP) Requirement

Heads continue to spin (and cannabis business’ cash to hemorrhage) in response to the changes in the packaging requirements. As of July 1, 2018, all cannabis products were to be in child-resistant packaging, and retailers had converted back to the statutory requirement that all exit packaging was to be “opaque,” allowing them to use reusable totes and paper bags to satisfy this requirement. In the October regs, we saw a pivot that allowed for a seeming “grace period” for the child-resistant requirement to return to being able to be satisfied by the retail via CR exit bag. Some confusion remained as to whether products that were already IN child-resistant packaging would have to be put INSIDE of child-resistant packaging for the next year. The addition of the statement from the CDPH, “Until the date specified [1/1/20] the child-resistant package requirement [§26120] may be met through the use of a child-resistant exit package at retail sale.” (CDPH §40417.d) suggests that the significant ecological impact of CR packaging within CR packaging MAY be avoided, however, most legal counsel will probably be advising retail clients to use the CR exit bag to avoid potential liabilities. Viva Kafka!   

In the CDPH’s Statement of Reasons, they said “This is necessary to comply with the packaging requirements in Business and Professions Code section 26120 while providing licensees with time to comply with packaging requirements.” Compliant operators were left somewhat confused, as they had been required to comply with these packaging requirements since July!

8. OSHA Training for Everyone!  

All three regulatory agencies added the following requirement for OSHA training:

“For an applicant with more than one employee, the applicant shall attest that the applicant employs, or will employ within one year of receiving a license, one supervisor and one employee who have successfully completed a Cal-OSHA 30-hour general industry outreach course offered by a training provider that is authorized by an OSHA Training Institute Education Center to provide the course.”

This will be an additional training requirement, on top of existing state and local training requirements for cannabis operators. And remember, all that training documentation must be kept, like all other records, for seven years!

As with everything in life, more will be revealed as we get deeper into 2019.  

Juli Crockett is a member of the NCIA’s State Regulations Committee and is Director of Compliance at MMLG. Slides from Juli’s recent Workshop on this topic are available for download here. You can also watch the workshop video in its entirety on MMLG’s Facebook page.

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