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  • Proposition 65’s Warning Requirements and Cannabis Businesses

     

    WARNING: New Proposition 65 Notice Requirements Coming Soon!

    OVERVIEW

    California’s Proposition 65, a voter initiative passed in 1986, created the Safe Drinking Water and Toxic Enforcement Act (Health & Safety Code § 25249.5 et seq.), which requires that the seller of a product that contains chemical(s) known by the State of California to cause cancer or reproductive harm must provide a warning to anyone who buys the product, unless there is already a clear and sufficient warning printed on the label or package. Warnings must also be given if there is a possibility of environmental exposure to a chemical on the list of substances that cause cancer or reproductive harm. Penalties for violating Proposition 65’s warning requirement can be as high as $2,500 per day.

    The Proposition 65 list can be found at https://oehha.ca.gov/proposition-65/proposition-65-list.

    Proposition 65 is enforced by the California Attorney General’s office; however, the law also gives a private right of action to individuals acting in the public interest, who may file a lawsuit alleging that a business is in violation of the law. Many private attorneys are involved in filing these notices, and the attorney fees awarded are usually significant.

    The warning required under Proposition 65 must be “reasonably calculated” to be available to an individual prior to exposure, and must clearly communicate that the chemical in question is known to cause cancer or reproductive harm. “Exposure” in this context is defined as: “to cause to ingest, inhale, contact via body surfaces or otherwise come into contact with a listed chemical,” and can occur through use of consumer products as well as through the environment.

    For products, the warning must be “prominently placed upon a product’s label or other labeling or displayed at the retail outlet with such conspicuousness, as compared with other words, statements, designs, or devices in the label, labeling or display as to render it likely to be read and understood by an ordinary individual under customary conditions of purchase or use.” A system of signs, a public advertising system, or any other system that provides clear and reasonable warnings is also sufficient. This could include a warning printed on each customer receipt, or included as part of a membership agreement, if one exists, depending on the circumstances. For environmental exposure, in addition to the warning methods mentioned above, warnings can also be provided by a mailed or delivered notice to each occupant of the affected area at least once every three months, or via public media announcements targeted to the affected area at least once every three months.

    Currently, the consumer product warning for a carcinogen must include the following language:

    “WARNING: This product contains a chemical known to the State of California to cause cancer.”

    The current environmental exposure warning for a carcinogen must include the following language:

    “WARNING: This area contains a chemical known to the State of California to cause cancer.”

    The required warnings for chemicals known to cause reproductive harm are identical, except the word “cancer” is replaced with “birth defects or other reproductive harm.”

     

    NEW RULES COMING

    California’s Office of Environmental Health Hazard Assessment (OEHHA), the agency that oversees Proposition 65 enforcement, issued new warning regulations in late 2016 that will go into effect on August 30, 2018. The new regulations are designed to provide consumers with more specific notice of the chemicals contained in products sold within the state. Between now and August 30, 2018, businesses can choose to continue following the existing regulations or to begin following the new regulations immediately. (For a side-by-side comparison of the current and new reasonable warning regulations, go to https://oehha.ca.gov/media/downloads/crnr/side-sidearticle6090116.pdf.)

    The new regulations place the burden to warn on manufacturers and distributors rather than on retailers, though there are instances when a warning by the retail seller is required. Additionally, as long as the consumer ultimately receives an adequate warning, an arrangement may be reached between a retail seller and a manufacturer, producer, packager, importer, supplier, or distributor to allocate legal responsibility for providing the warning.

    Warnings under the new regulations must be provided via signs and/or product labeling as applicable. For warning signs in retail establishments, the new regulations still require the warnings to be prominently displayed with conspicuous signage, so as to render them likely to be read and understood by an ordinary customer. Regarding additions to the warning, the warning may contain supplemental information “only to the extent that it identifies the source of the exposure or provides information on how to avoid or reduce exposure to the identified chemical or chemicals,” and any such supplemental information is not a substitute for the required warning.

    The new exposure warning messages must include the following:

    (1) A symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline. Where the sign, label or shelf tag for the product is not printed using the color yellow, the symbol may be printed in black and white. The symbol shall be placed to the left of the text of the warning, in a size no smaller than the height of the word “WARNING”.

    (2) The word “WARNING” in all capital letters and bold print, and:

    (A) For exposures to listed carcinogens, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.”

    Additionally, on-product warnings for products containing a known cancer-causing agent require the symbol required in §25603(a)(1), the word “WARNING” in bold capital letters, and the following words: “Cancer – www.P65Warnings.ca.gov.” The name of the listed chemical is not required to be printed on a product warning label.

    The major differences between the current and the new “clear and reasonable” warning regulations are: (i) that the current regulations do not require that the specific listed chemical be identified, whereas the new regulations do; (ii) a change in the appearance of the warning sign, which will now require a yellow (or black-and-white) triangle with an exclamation point; and (iii) a clear preference for placing the burden to warn on manufacturers and packagers rather than retail sellers where possible, while also providing a mechanism to allocate legal responsibility for providing such warnings.

     

    EXCEPTIONS

     Businesses that employ nine or fewer employees are exempt from the reasonable warning requirement. Additionally, only marijuana smoke is included on the Prop. 65 list of cancer-causing substances, so warnings may not be required for edible or topical marijuana products, provided they do not contain another chemical on the Prop. 65 list, such as certain pesticides. A warning still may be required on some marijuana products that can be vaporized, since certain chemicals used in vapor products may be included on this list.

     

    APPLICATION TO CANNABIS BUSINESSES

    Marijuana smoke was added to the list of substances known by the State of California to cause cancer in 2009. Recently, a number of medical cannabis dispensaries throughout the state have received 60-day notices of allegedly violating the clear and reasonable warning requirement. Therefore, medical marijuana dispensary operators should provide a warning, since some products being sold (i.e., any marijuana intended for use by combustion or vaporization) can be used in a way that, according to the State of California, could expose the user to a cancer-causing agent. This is not required if all such products already have clear warnings on their packages or labels. Additionally, dispensaries that permit smoking or vaporizing on-site should provide a warning for environmental exposure. These warnings must be placed in a location where an average customer is likely to see them.

    Under the new regulations, which go into effect in August 2018, the burden placed on retailers will be minimized. Retailers of cannabis will not be responsible for providing the required warnings unless: (i) the retailer is responsible for introducing a listed chemical into a product; (ii) the retailer agrees to take on this responsibility; (iii) the retailer is selling the product under a brand or trademark that is owned or licensed by the retailer or an affiliated agency; (iv) the retailer obscured or did not conspicuously display warning labels or signage that were provided; or (v) the retailer has actual knowledge of potential consumer exposure that would require a warning, and there is no manufacturer, producer, packager, importer, supplier, or distributor of the product who is a “person in the course of doing business” and has designated an agent for service of process in California or has a place of business in California.

    Retailers are explicitly authorized to enter into arrangements with providers of packaged smokeable or vaporizable marijuana products to allocate legal responsibility for providing Prop. 65 warnings. However, the providers of the packaged products have the option of including the required warning directly on the product label or providing an accompanying written warning to the retailer along with the product. If the latter method is chosen, then the notice must be renewed every six months and the retailer is responsible for the placement and maintenance of the warning materials.

    Below are examples of warnings that comply with the new regulations, which go into effect on August 30, 2018:

     

    WARNING: This product can expose you to marijuana smoke, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.

     

     

     

    WARNING: Entering this area can expose you to marijuana smoke. Marijuana smoke is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.

     

    As noted, Proposition 65 can be enforced by both a public and private right of action, so individuals can serve businesses who they allege to be in violation of the Act with a 60-Day Notice of Violation and can then file a civil lawsuit against the alleged violator if an agreement to resolve the violation is not reached. A number of medical marijuana dispensaries have been targeted in this manner over the past years. Apparently, all of these cases resulted in either a settlement or a consent judgment.

    Moreover, marijuana smoke is not the only chemical known to the State of California to cause cancer that a dispensary might encounter: pesticides such as myclobutanil and carbaryl are on the Proposition 65 list, and a number of medical cannabis dispensaries throughout California have recently received 60-Day Notices for edible cannabis products allegedly containing myclobutanil or carbaryl.

    To view the Attorney General’s database of marijuana-smoke-related Prop. 65 60-Day Notices, visit https://oag.ca.gov/prop65/60-day-notice-search and search for “Marijuana smoke” in the “Chemical” box.

    Searches for “Marijuana smoke“, “Myclobutanil“, and “Carbaryl” reveal that dozens of 60-Day Notices have been reportedly served on California medical cannabis businesses throughout the state.

    Because marijuana smoke and other pesticides which may be found in cannabis products are currently listed as cancer-causing substances by the OEHHA, and because several dispensaries have been targeted for not providing such warnings, it is advised that medical cannabis dispensaries provide the warnings called for under Proposition 65, despite some evidence suggesting that marijuana may actually help treat cancer. It is also advised that packagers of cannabis products start preparing to include Proposition 65 warnings on their labels or to provide these warnings to retailers, or to make agreements with retailers as to who will take on this responsibility.

    There is nothing that prevents a cannabis dispensary from including additional signage that states the facility disagrees with the required warnings.

    For more information on Proposition 65, go to https://oehha.ca.gov/proposition-65/.

     

    Remember: laws, rules, and regulations are constantly changing.  The above information is not intended as legal advice; please contact the Law Offices of Omar Figueroa for legal advice on how to comply with Proposition 65 at (415) 489-0420 or (707) 829-0215.

  • Challenging Proposed Regulations for Lack of Necessity

    One way to challenge California’s proposed medical cannabis regulations is to argue that the record of rule making fails to establish the need for a particular regulation.


    California Government Code § 11349(a) defines necessity in the context of proposed regulations:
    “‘Necessity’ means the record of the rulemaking proceeding demonstrates by substantial evidence the need for a regulation to effectuate the purpose of the statute, court decision, or other provision of law that the regulation implements, interprets, or makes specific, taking into account the totality of the record. For purposes of this standard, evidence includes, but is not limited to, facts, studies, and expert opinion.”

    In other words, if the record of the rule making proceeding fails to show, by substantial evidence, the need for a particular regulation, that regulation is susceptible to a necessity challenge.

    For an example of a proposed California medical cannabis regulation which may be susceptible to a necessity challenge, the manufacturing ISOR does little to establish the necessity of the categorical prohibition on cannabis-infused caffeine products set forth in proposed Section 40300. The ISOR states:


    “The recommendation that caffeine not be allowed as an additive comes from the FDA determination that caffeine (stimulant) in certain alcoholic (depressant) beverages is an “unsafe food additive” due to the unpredictable negative effects of the two substances. The mixing of stimulants with depressants may lead to dangerous cardiac events. A similar lack of definitive information exists as well for the safety of caffeine as an additive to cannabis.”

    The ISOR cites no facts, studies, or expert opinions to establish the necessity of the ban on caffeine, and the record of the rule making proceeding at this juncture appears insufficient to establish by substantial evidence the necessity of a categorical prohibition on caffeine.

    You can easily find Section 40300 of the regulations proposed by the Office of Manufactured Cannabis Safety as well as the corresponding ISOR on the Regulations page of the Law Offices of Omar Figueroa web site:
    http://californiacannabisregulations.com
    http://http://www.omarfigueroa.com/wp-content/uploads/2012/07/OMCSCombined.pdf

    The California Office of Administrative Law has a very informative web site collecting written decisions disapproving of agency regulatory actions.  These decision identify proposed regulations which were rejected as defective. An example of a recent Disapproval Decision is the disapproval of the Department of Alcoholic Beverage Control’s proposed regulatory action for “failure to comply with the “necessity” and “clarity” standards of Government Code section 11349.1 and failure to follow all required procedures under the California Administrative Procedure Act (APA).”

    http://www.oal.ca.gov/publications/disapproval_decisions/

    https://oal.blogs.ca.gov/files/2017/04/2017-0213-01S_ABC_Disapproval-Decision.pdf

     

    The above information is provided for informational purposes only and is not intended as legal advice.  Please contact a lawyer for legal counsel.

    If you would like legal assistance in advocating for changes to the proposed regulations, please get in touch with us at (707) 829-0215 or at (415) 489-0420.

  • Draft Regs: Potential Issues Related to “Ownership”

     

    The proposed medical cannabis regulations released by California’s medical cannabis regulatory agencies — the Bureau of Medical Cannabis Regulation (BMCR), the Department of Food and Agriculture (CDFA), and the Department of Public Health (CDPH) — would require licensees to submit a new application any time there is a change in ownership or organizational structure.

    This is potentially problematic for cannabis companies for two reasons. First, the definition of “owner” is very broad, and it includes the following: 

    For public companies, an owner is anyone holding 5% or more interest in the company.
    For private companies an owner is any of the following:
    Someone holding an aggregate ownership interest (other than a security interest, lien, or encumbrance) of 20% or more interest in the cannabis business;
    The CEO and all members of the board of directors of any entity that holds an aggregate ownership interest of 20% or more in the cannabis business; or
    Any other person who participates in the direction, control or management of the commercial cannabis business.

    (BMCR § 5004; similar provisions are contained in CDFA’s and CDPH’s proposed regulations.) All individuals and entities considered to be “owners” must disclose personal and financial information about themselves. 

    Each individual named on this list shall submit the following information:
    (A) The full name of the owner.
    (B) The owner’s title within the applicant entity.
    (C) The owner’s date of birth and place of birth.
    (D) The owner’s social security number or individual taxpayer identification number.
    (E) The owner’s home address.
    (F) The owner’s telephone number. This may include a number for the owner’s home, business, or mobile telephone.
    (G) The owner’s email address.
    (H) The date the owner acquired an ownership interest in the applicant entity.
    (I) The percentage of the ownership interest held in the applicant entity by the owner.
    (J) If applicable, the number of shares in the applicant entity that the owner holds.
    (K) Whether the owner has a financial interest in any other licensee under the Act. For purposes of this section “financial interest” means an investment into a commercial cannabis business, a loan provided to a commercial cannabis business, or any other equity interest in a commercial cannabis business.
    (L) A copy of the owner’s government-issued identification. Acceptable forms of identification are a document issued by a federal, state, county, or municipal government that includes the name, date of birth, physical description, and picture of the person, such as a driver license.
    (M) A detailed description of the owner’s convictions. A conviction within the meaning of this section means a plea or verdict of guilty or a conviction following a plea of nolo contendere. Convictions dismissed under Penal Code section 1203.4 or equivalent non-California law must be disclosed. Juvenile adjudications and traffic infractions under $300 that did not involve alcohol, dangerous drugs, or controlled substances do not need to be included. For each conviction, the owner shall provide the following:
    (i) The date of conviction.
    (ii) Dates of incarceration if applicable.
    (iii) Dates of probation if applicable.
    (iv) Dates of parole if applicable.
    (v) A detailed description of the offense for which the owner was convicted.
    (vi) A statement of rehabilitation for each conviction. The statement of rehabilitation is to be written by the owner and shall contain all evidence that the owner would like the bureau to consider that demonstrates the owner’s fitness for licensure. Supporting evidence may be attached to the statement of rehabilitation and may include, but is not limited to, a certificate of rehabilitation under Penal Code section 4852.01, and dated letters of reference from employers, instructors, or professional counselors that contain valid contact information for the individual providing the reference.
    (N) A copy of the owner’s completed application for electronic fingerprint images submitted to the Department of Justice.
    (O) Attestation to the following statement: Under penalty of perjury, I hereby declare that the information contained within and submitted with the application is complete, true, and accurate. I understand that a misrepresentation of fact is cause for rejection of this application, denial of the license, or revocation of a license issued.
    (P) The following information regarding an individual with a community property interest in the commercial cannabis business under Family Code section 760 shall be provided by the owner:
    (i) The full name of the individual.
    (ii) The individual’s date of birth and place of birth.
    (iii) The individual’s social security number or individual taxpayer identification number.
    (iv) The individual’s mailing address.
    (v) The individual’s telephone number. This may include a number for the owner’s home, business, or mobile telephone.
    (vi) Whether the individual has a financial interest in any other licensee under the Act. For purposes of this section “financial interest” means an investment into a commercial cannabis business, a loan provided to a commercial cannabis business, or any other equity interest in a commercial cannabis business.

    (BMCR § 5006; similar provisions are contained in CDFA’s and CDPH’s proposed regulations.) As noted, the draft regulations would require submitting a new license application any time the ownership of a cannabis business changed. It seems excessive to require a new license to be obtained whenever a single individual who may be considered an “owner” is added to or removed from the company. For example, let’s say an LLC held a 25% interest in another company that has a commercial cannabis license. If one member of the LLC’s board of directors changed, then the other company would have to re-apply for an entirely new license to continue operating the way it had been, even though its board may not have changed and even though the LLC still holds a 25% interest.

    Second, the requirement that a new application be submitted whenever there is a change in the organizational structure of a commercial cannabis business is troubling. For  years in California, many medical cannabis businesses have structured their entities as nonprofit mutual benefit corporations (MBCs) or nonprofit cooperatives. This is because Senate Bill 420 stated it did not authorize “any individual or group to cultivate or distribute marijuana for profit,” and that qualified patients and primary caregivers who “collectively or cooperatively cultivate cannabis for medical purposes, shall not solely on the basis of that fact be subject to state criminal sanctions under Section 11357, 11358, 11359, 11360, 11366, 11366.5, or 11570.” In 2008, California’s state Attorney General Edmund Brown issued “Guidelines for the Security and Non-Diversion of Marijuana Grown for Medical Use” which talked about statutory cooperatives (agricultural and consumer) and non-statutory collectives as being two types of options for medical cannabis patients and caregivers to “collectively or cooperatively” grow cannabis.

    Now, however, the tide has shifted. Under the Medical Cannabis Regulation and Safety Act (MCRSA), a “person” is defined as an individual or corporate entity, and it is implied that medical cannabis businesses may no longer have to operate on a not-for-profit basis under this new regulatory scheme. To clear this up, there is a bill pending in the state legislature, AB64, which would explicitly state that medical cannabis licensees may lawfully operate on a for-profit basis. (AB 64 would do a number of other things as well, such as allow for cannabis-specific state trademarks and place certain restrictions on cannabis advertising.) Thus, the need for nonprofit cooperatives and collectives will be largely gone soon (not to mention the collective and cooperative provision, Health & Safety Code § 11362.775, has a sunset clause which will likely take effect in early January of 2019, 12 months after the state licenses are issued), and many of these existing cannabis companies that are set up as MBCs or statutory cooperatives will likely want to restructure their entity in a way that makes sense for their business. It seems unnecessary and overly burdensome to require a cannabis company to submit a new license application whenever its organizational structure changes, especially since licensees are already required to notify their licensing agency when there is a change in any item listed in the application, which would include the list of owners and entity structure.

    This could also create problems between local jurisdictions and the state. If the state requires one to obtain a new license every time ownership changes, then the local permit that was issued to the company before its change in ownership may no longer be valid, triggering the need to go back and get a new local permit as well. However, a local jurisdiction may not be issuing any new cannabis permits, meaning the company that previously had a local permit and state license would suddenly be without a valid local permit or authorization, simply due to what could be a minor change in ownership or entity structure.

    Additionally, the proposed regulations explicitly do not allow for the transfer of licenses, and the requirement that a new license be obtained whenever there is a change in ownership or organizational structure effectively prohibits the transfer of licenses as well. For example, let’s say Dispensary A is licensed. Mr. B wants to buy Dispensary A, because he wants a licensed dispensary. Mr. B makes the arrangements and buys Dispensary A, but Dispensary A’s license becomes invalid as soon as the transaction is complete since there is now a new owner who must apply for a new license. This is likely not how most investors and operators in the cannabis industry envisioned an industry-friendly license transfer process.

    If you have concerns with any of the proposed regulations, please make sure your comments are submitted by 5:00pm on June 13/14/20 (depending on which license type), 2017. Information about submitting a public comment can be found here: BMCR, CDPH, CDFA. You can comment in writing or in person at one of the scheduled public hearings.

     

    The above information is for informational purposes only, may become outdated, and is not intended as legal advice.  Please consult with a lawyer for legal counsel.  Please contact the Law Offices of Omar Figueroa if you have questions about the regulatory process or would like the assistance of counsel in advocating for changes to the proposed regulations.

  • Trailer Bill Seeks to Reconcile Medical and Adult Use Cannabis

    In 2015, the California legislature passed the Medical Cannabis Regulation and Safety Act (MCRSA), which set up a regulatory structure for medical cannabis within the state. In 2016, California voters approved Proposition 64, also known as the Adult Use of Marijuana Act (AUMA), which quasi-legalized cannabis for adult use. AUMA and MCRSA are similar, but have some key differences, such as their definitions of “owner”; MCRSA’s requirement of mandatory independent distributors; MCRSA’s limitations on vertical integration; and AUMA’s residency requirement.

    Last month, Governor Brown released his proposed trailer bill, which seeks to reconcile MCRSA and AUMA. The goal of his proposal is to unify California’s medical and adult use cannabis systems while still maintaining separate licenses for medical and adult use businesses. The trailer bill is essentially a rider on the state budget. Like other bills, it must be voted on by the legislature before it becomes law, and requires a 2/3 vote. However, given that the majority of the California legislators are Democrats who will likely want to pass their Democratic governor’s budget, it is likely that the trailer bill will pass in some form. [Are amendments allowed? Look into]

    Where AUMA and MCRSA differ, the trailer bill typically chooses AUMA’s model. For instance, the trailer bill would allow other licensees to hold distributor licenses, eliminating the need for an independent distributor. The trailer bill would also allow for vertical integration of all license types except laboratories, as set out in AUMA. However, in certain areas, Governor Brown has proposed to follow MCRSA’s outline, for example by removing the 2-year residency requirement from AUMA. The trailer bill would also change the name of AUMA to the Medicinal and Adult-Use Cannabis Regulation and Safety Act (quite a mouthful!).

    The trailer bill would require anyone applying for a cannabis license to indicate whether they are applying for an adult use license (“A-Licenses”) or a medical license (“M-Licenses”). A licensee can hold both types of licenses, but wouldn’t be able to operate a medical cannabis business and an adult use cannabis business on the same premises. The trailer bill would put the burden on the state licensing agency to make sure an applicant is in compliance with local laws, rather than putting the burden on the applicant to prove they are locally compliant.

    Governor Brown is also proposing to eliminate the voluntary city/county medical marijuana ID card program, and making it such that a physician’s recommendation would be sufficient to get the sales and use tax break given to qualified medical cannabis patients. (This benefit is currently tied to the voluntary ID card under AUMA.)

    If the trailer bill passes, the three agencies tasked with regulating cannabis within California (the Department of Consumer Affairs, Bureau of Marijuana Control; the Department of Food and Agriculture, CalCannabis Licensing; and the Department of Public Health, Office of Manufactured Cannabis Safety) will withdraw the proposed regulations they just released and issue new ones that comport with the trailer bill.

    Stay tuned for more updates!

    Trailer Bill Language – Cannabis Regulation

    Legislative Analyst’s Office Comments on Trailer Bill

    California NORML’s Summary of the Trailer Bill

  • Charges dismissed against Vallejo pot dispensary operator, star of ‘Weed Country’

    Times-Herald

    Year-old criminal charges were dismissed Thursday against Matt Shotwell, a one-time operator of one of Vallejo’s largest medical marijuana dispensaries. Since February 2012, when the Vallejo Police Department’s series of raids on medical marijuana dispensaries launched with Shotwell’s arrest at Greenwell Cooperative dispensary, no operators have been convicted.

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