Track-and-Trace: Cannabis Cultivation, Distribution, and Use

On January 1, 2018, the State of California plans to remove state prohibitions on cannabis cultivation, distribution, and use. This will allow medicinal and recreational use by adults. The cash-strapped state government sees an opportunity to increase revenue by bringing the illicit market into a state-regulated and taxed licit market.

Because the date is only five weeks off, California formally adopted the draft rules that had been in the review process on November 18, 2017. These emergency regulations total almost 300 pages. The plan is for the emergency period to cover the first 120 days. There are many gaps or reserved numbers to be filled in later. The rules start with creating the Bureau of Cannabis Control.

A quick perusal of the regulatory structure shows that the BCC will regulate the cannabis market in California by closely monitoring the supply chain from seed to consumer through a series of reporting requirements and licenses. The BCC is empowered to inspect all records related to the growth, processing, and sale of cannabis plants or products. If the process works, it will be very difficult for illicit growers to get their material into the licit supply chain. After all, the state wants to protect its new revenue source.

The traditional supply chain for illicit cannabis involved small entrepreneurial growers selling to distributors who organized and managed a shady sales network. Product quality and safety relied on the reputation and assurances of the dealers.

California’s business model for 2018 relies on a detailed “track and trace” process starting from plant nursery, on to the farmer, harvest, processor, distributor, retailer, and finally to the customer. The rules create a supply-chain “paper trail” designed to prevent entry to unlicensed cannabis and assure product quality, public safety, and revenue for state and local taxing authorities. Plus, there is a new requirement for analysis of the products, which is the focus of this report.

To see how this program is designed to operate for the labs, let’s start with the requirements for the temporary license covering the first 120 days of 2018. These requirements are similar to the permanent license that will cover the remainder of 2018 (California Code of Regulations, Title 16. Div. 42, Bureau of Marijuana Control, Chap. 5, Testing Laboratories. The document is divided into consecutively numbered sections starting with 5238). The laboratory regulations are presented in a 46-page document that is part of a 270-page tome covering the emergency regulations of the new Bureau of Cannabis Control.

For a proposed cannabis analysis laboratory, the process starts with a license application described in article 2 (5238). This includes:

  • Proof of ISO 17025 accreditation
  • Identification and qualifications of laboratory staff
  • Copies of all standard operating procedures
  • Obtaining $2 million in general liability insurance for each loss
  • A $5000 bond payable to the State of California
  • Local jurisdictional authorization issued by the local government allowing the applicant to conduct a commercial cannabis activity at the location
  • Authorization to use the location, such as a copy of the deed for the proposed location. If not owned by the applicant, the owner must give the applicant permission to use the location in a commercial cannabis activity
  • Premises diagram, including a statement of the activity in each room or area, such as sample receiving, sample storage, record storage, microbiology, analytical chemistry, office space, etc.
  • A list of owners of the laboratory with a listing of interests in cannabis businesses. This should include place of birth, social security number, taxpayer identification number, current employer, percentage of ownership in the laboratory business, driver’s license, criminal history, and fingerprints.

To avoid conflicts of interest and self-dealing, laboratory owners and managers may not have financial interests in other cannabis-related businesses (i.e., grower, retailer, distributor, etc.). Since the retail price of cannabis products is expected to be over $5000/lb, BCC intends to be vigilant in looking for diversions of sample material. Because the time is short, the BCC can grant applicants a provisional license that is valid for one year from date of issue.

Article 3 (5247) focuses on Sampling Medicinal Cannabis Goods. This includes:

  • Developing and implementing sampling plans that are suitable for the purpose and matrix
  • The sampling plan must be under document control. Signature of the laboratory director denotes approval of the plan. The plan will include a revision log with dates and authors
  • Sampling plans shall be available for inspection by the BCC.

According to section 5250, the laboratory shall obtain samples for analysis of homogeneity, as well as presence or absence of: cannabinoids; residual solvents; pesticides, including residues; heavy metals; microorganisms; mycotoxins; water content; filth; foreign materials; and terpenes.

Only the laboratory that collects the sample can analyze the sample, and the sampler must be an employee of the laboratory.

The sampler must obtain primary and duplicate samples for each batch and assign a unique identification to each sample. Further, the sampler will follow a chain-of-custody protocol to ensure sample integrity from collection to assay.

The sampler shall also wear protective equipment (disposable coat, gloves, dust mask, goggles, hair net). Gloves must be replaced between sampling different batches.

As per section 5256, Sampling Tools, the sampler shall sanitize all tools and equipment used in the sampling process. Tools may include amber glass jars with PTFE-lined lids, cooler with cold packs, cleaning fluids such as 70% ethanol or 10% bleach, disposable gloves, field balance capable of 1-g accuracy, labels and permanent markers, disinfecting wipes, spoons, tongs, knives, sampling thieves, pipettes, etc.

According to section 5259, Field Duplicate Sampling, the sampler shall collect a field duplicate sample at the same time and in the same manner from the same batch as the primary sample. The duplicate shall be separately stored and analyzed from the primary sample.

As per section 5262, Sample Storage and Handling, the sampler will place samples in a tamper-evident container. In addition, samples shall be kept cool (between 0 to 6 oC) inside a chest.

Field log

The sampler shall maintain a field log to record:

  • Lab’s name and license number
  • Sampler’s name and title
  • Names of other staff on site
  • Date and time the sampling began
  • Distributor’s name, address, and license number
  • Name, business address, and license number of the person who transports the samples to the laboratory

Sample matrix

  • Requested assays
  • Total composite weight or count
  • Date and time each sample was obtained
  • Total batch size by weight or count
  • The weight or count of the sample, unique identification number, and location within the batch from which sample was taken
  • Problems encountered and corrective actions taken
  • Other observations from the sampling process, including odor, color, and size
  • Sampling conditions, including temperature.

As per section 5268, Sampling Unpackaged Harvest Batches:

  • Samples must be representative of the batch
  • Samples may be obtained from the container holding the batch
  • The maximum size of a harvest batch is 10 lb; samples from larger batches are invalid
  • The sampler shall sample by performing all of the following tasks:
    • Draw samples from various locations of the container, vertically and horizontally, using a heptagonal pattern
    • Remove dried flower and place it in an airtight container
    • Seal all openings with a tamper-evident seal, and initial and date each seal
    • Place samples in a tamper-evident, portable storage unit capable of maintaining sample at 0–6 °C
    • Complete a chain-of-custody form and sample field log.

According to Minimum Unpackaged Harvest Batch Sample Size (5271–5274), the sampler shall collect a minimum of 0.5% of the total batch size. The sample size requirement is given in the following table:

Batch size in pounds

Required sample size (grams)

Sample increments/batch

<1.00

2.3

7

1.01 to 2.0

4.5

7

2.01 to 3.0

6.8

7

3.01 to 4.0

9.1

7

4.01 to 5.0

11.3

8

5.01 to 6.0

13.6

8

6.01 to 7.0

15.9

8

7.01 to 8.0

18.1

8

8.01 to 9

20.4

9

9.01 to 10

22.7

9

As per section 5298, “Testing Methodologies (a),” Laboratories shall develop and implement scientifically valid testing methodologies for the chemical, physical, and microbial analysis of medicinal cannabis goods. A method validated in accordance with this section is deemed a scientifically valid testing methodology. A laboratory shall not perform testing using a method that has not been validated.

Another fine point is the requirements for weighing cannabis products from the California Division of Measurement Standards (CaDMS). With the high price of THC containing cannabis (~$320/oz) and the maximum possession limit of 8 oz, CaDMS specifies a new set of scales for cannabis trade, recommending that a medicinal cannabis dispensary has a maximum weighing capacity of 1 kg or 32 oz. The readability should be no larger than 0.05 g or 0.0001lb. This is called a Class II scale. Using a Class III scale typically used in grocery and meat markets could result in a weighing error of ±25%, which could be a serious financial loss to the buyer or seller. Further, CaDMS intends to use unannounced on-site inspections to assure compliance. Prepackaged products will be inspected for suitable accuracy and agreement with the package label.

Summary

The government of California is moving rapidly to set up a robust regulatory framework to support both medicinal and recreational cannabis products. Track-and-trace methodology should protect the licit supply chain and differentiate it from the traditional (illicit) market. The regulators recognize that the time to set up these systems is very short. Thus, they have divided the timeline into a soft approach where expeditious compromises will be made for the first 120 days following January 1, 2018. The second, or permanent, stage will involve rigorous enforcement of the license and record-keeping regulations.

The analytical chemistry requirements will be reviewed in subsequent reports.

Robert L. Stevenson, Ph.D., is Editor Emeritus, American Laboratory/Labcompare; e-mail: [email protected]

Related Products

Comments