The Bureau of Medical Cannabis Regulations (BMCR), the California Department of Public Health under the guise of the Office of Manufactured Cannabis Safety (OMCS), and the California Department of Food and Agriculture (CalCannabis) released hundreds of pages of proposed regulations on the medical cannabis industry April 28.
It is important to note that these regulations only affect the medical market, creating a double-standard where the adult-use market is held to lower standards of testing and allowed higher potencies. Many sources have raised concern over various parts of the regulations which I will discuss in this blog post.
This article was first published May 25, 2017, as a blog for Pistil + Stigma, a boutique cannabis consulting firm, focused on government compliance issues.
Now is a crucial time for anyone interested in California’s cannabis industry, because public comment is open on these regulations only until June 13 or 14 depending on the state agency. The final public hearings will be held June 13 in San Jose. One of the three agencies taking comments, CalCannabis, has given these three helpful tips to anyone planning to submit a comment:
- Be concise and focus directly on the proposed medical cultivation regulations.
- Identify the specific part of the proposed medical cultivation regulations you are commenting on (if possible, indicate the regulation section number you’re referring to).
- Include supporting evidence and facts, and provide complete references and/or citations, particularly if you’re referring to a website (for example, provide the specific website url).
It is with those tips in mind that I prepared the following guide to some of the more problematic areas of the proposed regulations. Each problem area clearly states what statutory section (§), section, sub-section, etc. is being cited so that you will know for your comment what part to reference, or for your personal research, what area of code you should look up.
Out of more than a thousand pages of regulations, this is far from an exhaustive list, just some areas that are most commonly discussed as raising the most concern among patients and the industry.
The astute reader will notice that none of these most problematic areas come from CalCannabis, which is largely a result of the California Growers Association being intimately involved in the crafting of their regulations, while many manufacturers and others in the industry took a hands-off approach, letting the chips fall where they may. Let this be a lesson in effective lobbying and politicking.
PROBLEM AREA 1: No deliveries to public housing (BMCR)
5190. DELIVERY TO PHYSICAL ADDRESS
“(c)A licensed dispensary shall not deliver medical cannabis goods to an address located on publicly owned land or any address on land or in a building leased by a public agency.”
- This means no deliveries to anyone who is living in Federal or State housing, and may leave many seniors and low income patients without the option of delivery.
PROBLEM AREA 2: No free samples or donations of cannabis products (BMCR)
5178. CUSTOMER SAMPLES
“(a) A licensed dispensary shall not provide free samples of medical cannabis goods to any person.”
- Looking at the Initial Statement of Reasons (ISOR), the concern is that samples will not be adequately tested, and that if dispensaries can give free samples then there is a risk of abusing the Track and Trace system. This ban even applies to third party vendors giving out samples at dispensaries.
PROBLEM AREA 3: No dairy, strict limits on edibles (OMCS)
40300. PROHIBITED PRODUCTS
“(c) No cannabis product shall be made of potentially hazardous food. Potentially hazardous food means any food capable of supporting the growth of infectious or toxigenic microorganisms when held at temperatures above 41 degrees Fahrenheit. This includes the following:”
- Products cannot be infused with nicotine or added caffeine; it is not clear if this includes natural caffeine in coffee or chocolate.
- Products are prohibited from including dairy products of any kind, canned products, juice, meat, seafood, or anything that “must be held at or below 41 degrees Fahrenheit to keep it safe for human consumption.” This will eliminate numerous products from the market, prevent countless more from coming to the market, and may pose problems for infused catering. There does not appear to be any distinction between goods which are shelf stable and those that are perishable, as the ingredients themselves are banned. This section of the regulations perhaps needs more clarification than any other.
40305. EDIBLE PRODUCTS – SERVING SIZE.
“(a) Edible cannabis products shall not contain more than ten (10) milligrams of THC per serving or more than one hundred (100) milligrams of THC per package of finished product.
(b)Edible products that constitute more than a single serving shall be scored, delineated, or otherwise similarly marked to indicate one serving.”
- While other forms of manufactured cannabis, such as tinctures, have a limit of 1,000 mg of THC, edibles are capped at 100mg due to the perceived risk involved in using edibles. This ignores the fact that a tincture can be taken as an edible, that is, consumed as a tea. This limit also ignores the fact that many cancer patients and those with severe pain need more than 100mg per package due to how high of doses they are taking daily and that higher-concentrations often save them money.
40306. FINISHED CANNABIS PRODUCTS – MAXIMUM THC CONTENT.
“For manufactured cannabis that is not an edible product, no package of finished cannabis product shall contain more than 1,000 mg of THC.”
- Hash, cartridges, tinctures, and any other products that are not edibles will be capped at 1,000mg of THC.
PROBLEM AREA 4: Alcohol based tinctures may be banned (OMCS)
40300. PROHIBITED PRODUCTS
“(a) No licensee shall infuse alcoholic beverages, as defined in section 23004 of the Business and Professions Code, with cannabis.” (Note: BPC 23004 defines an “alcoholic beverage” as a “liquid or solid” which contains more than 0.5% Alcohol-By-Volume).
- Tinctures are made through three methods of extraction. One uses vegetable glycerin and is the worst extractor; one uses oil, and one uses alcohol. By far the most common method of making tinctures is using alcohol, which results in a tincture with 40% ABV, this is true for herbal tinctures sold at Whole Foods as well as cannabis tinctures sold at dispensaries.
- Concerns have been raised by multiple oil tincture infusers who worry that the proposed regulations may also ban their method of infusing an oil tincture.
PROBLEM AREA 5: Prohibitive lab testing regulations (BMCR)
5238. APPLICATION
“(a) Proof of ISO 17025 accreditation or proof that the applicant is in the process of applying or is preparing to apply for ISO 17025 accreditation;”
- While it is important that all labs be ISO 17025 certified, it is worth recognizing that very few labs that are currently testing cannabis are ISO certified for some categories of testing. It is also important to note that with ISO certification, there is one for each type of testing (such as biological, calibration, chemical, environmental), so while a lab may be certified, it may still not be fully accredited across the board. Even if a lab is certified for something, such as heavy metals, there is still the chance they may not offer all needed tests.
5268. SAMPLING UNPACKAGED HARVEST BATCHES
“(c) A sampler may not collect samples from a harvest batch weighing more than 10 pounds. Samples collected from batches weighing more than 10 pounds shall be deemed invalid.”
- Concerns have been raised by growers, manufacturers, and testers, that this is an unreasonably low limit for batch size. The ISOR states that, “The bureau’s reason for imposing a harvest-batch size limit is to increase the accuracy of the tests,” and “Placing a maximum limit on the size of a batch for testing will also allow for more-manageable sample collection, transportation, storage, and testing.”
5373. PERSONNEL QUALIFICATIONS
“(c) Laboratory director. To be a laboratory director of a licensed testing laboratory under the Act, a person must satisfy one of the following: (1)(2)(3) ‘(3, 5, or 7) years of full-time practical experience in a post-education laboratory performing analytical scientific testing in which the testing methods are or were recognized by a laboratory-accrediting body;’”
- Because cannabis is federally illegal, any lab that is only testing cannabis will not be recognized by a laboratory-accrediting body.
5325. FILTH AND FOREIGN MATERIAL
“(a) A laboratory shall analyze all samples for filth and foreign material present in the sample.
(b) A sample is allowed an average of 5% mold or foreign material, by weight.”
- A concern has been raised that this may be an unacceptably high amount of mold to allow in products sold to immune compromised patients.
Some in the lab testing community are concerned with the near-zero limits set by § 5310. Residual Solvents and Processing Chemicals, § 5313. Residual Pesticides, and § 5328. Heavy Metals. The worry is that since so many labs will be doing types of testing they are new to, such as homogeneity testing in edibles and heavy metals testing, and since so many are not ISO certified, that this will lead to a major bottleneck in testing.
PROBLEM AREA 6: No bike courier deliveries (BMCR)
5124. TRANSPORT REQUIREMENTS
“(a)Transportation by means of … human powered vehicles… is prohibited.”
- The BMCR’s proposed regulations ban the use of bicycle couriers for cannabis, a commonplace practice in many cities around the country and a great way to be more environmentally friendly. If you look at the Initial Statement of Reasons, the only reason given is “the safety of the public and the medical cannabis goods.” If the cannabis was properly secured in a locked container, as required by § 5124, there is no reason why bikes should be a problem.
Want to do something about these regulations? Here’s how and where to submit a public comment:
PUBLIC HEARINGS
Office of Manufactured Cannabis Safety Public Hearings
TOMORROW: June 13, at 10am, 1350 Front St, Auditorium, San Diego, CA 92101
- Address: CA Dept of Public Health, Office of Regulations, 1415 L Street, Ste. 500, Sacramento, CA 95814
- Email: regulations@cdph.ca.gov
- FAX: (916) 440-5747
Bureau of Medical Cannabis Regulations Public Hearings
TOMORROW: June 13, at 1pm, San Jose (150 E. San Fernando Street, King Library, Second Floor) 95112
- Address: CA Dept of Consumer Affairs, Bureau of Medical Cannabis Regulation, Regulatory Office, PO Box 138200, Sacramento, CA 95813-8200
- Email: comments@dca.ca.gov
- FAX: (916)-574-8676
California Dept. of Food and Agriculture Public Hearings
WEDNESDAY: June 14, at 1pm, 1220 N Street, CA Dept of Food and Agriculture Auditorium, Sacramento, 95814
- Address: CA Dept of Food and Agriculture, Attn: Rachelle Kennedy, CalCannabis Cultivation Licensing, 1220 N St, Suite 400, Sacramento, CA 95814
- Email: CalCannabis@cdfa.ca.gov
- Phone: (916) 263-0801
- For Questions Relating to Water Diversion: Call the CA Water Resources Control Board at (916) 341-5300, or email them at WB-DWR-CannabisReg@waterboards.ca.gov
DEADLINE FOR PUBLIC COMMENTS
BMCR Deadline, Non-Lab: Tuesday, June 13, 2017, at 5 pm (PST)
OMCS Deadline: Tuesday, June 13, 2017, at 5 pm (PST)
CalCannabis Deadline: Wednesday, June 14, 2017, at 5 pm (PST)