CDPH-MCSB Proposed Reg. Update

CDPH-MCSB Proposed Reg. Update

CDPH-MCSB Proposed Reg. Update – Manufactured Cannabis Safety Board [“MCSB”] of the California Dept. of Public Health [“CDPH”] made very substantial changes to the Proposed Regulations in its October 19, 2018 revisions. While we have updated our FAQ’s and portions of our website to reflect the changes, we think they are significant enough to warrant a separate post. The full text of the regulations appears at the bottom of this post. If you need to access them in a different way, you can do so here.

Sections Deleted By New Regs

§40232. Requirements for Personnel

§40234. Grounds.

§40236. Premises Construction and Design.

§40238. Sanitary Operations.

§40240. Sanitary Facilities and Controls

§40242. Equipment and Utensils.

§40252. Quality of Raw Materials and Ingredients.

§40254. Manufacturing Operations.

§40256. Hazard Analysis.

§40258. Preventive Controls.

The following DO NOT constitute manufacturing:

The preparation of pre-rolls by a licensed distributor in accordance with the requirements of the Bureau specified in Section 5303 of Division 42 of Title 16 of the California Code of Regulations; [§40100 (dd)(2)(B)] or

The addition of cannabinoid content on the label of a package of cannabis or cannabis product by a distributor in accordance with Section 40409.

The addition of an OSHA training requirement:

For an applicant entity with more than one employee, 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. [§40128(b)(5)]

§40220. Permissible Extractions is modified to require that CO2 gas used for extraction shall be food grade;

New Sections Added By Proposed Regulations

§40179. Death, Incapacity, or Insolvency of a Licensee.

(a) In the event of the death, incapacity, receivership, assignment for the benefit of creditors or other event rendering one or more owners’ incapable of performing the duties associated with the license, the owner or owners’ successor in interest (e.g., appointed guardian, executor, administrator, receiver, trustee, or assignee) shall notify the Department in writing, within 10 business days.

(b) To continue operations or cancel the existing license, the successor in interest shall submit to the Department the following:

(1) The name of the successor in interest;

(2) The name of the owner(s) for which the successor in interest is succeeding and the license number;

(3) The phone number, mailing address, and email address of the successor in interest; and

(4) Documentation demonstrating that the owner(s) is incapable of performing the duties associated with the license such as a death certificate, or a court order, and documentation demonstrating that the person making the request is the owner or owners’ successor in interest such as a court order appointing guardianship, receivership, or a will or trust agreement.

(c) The Department may give the successor in interest written approval to continue operations on the licensed business premises for a period of time specified by the Department:

(1) If the successor in interest or another person has applied for a license from the Department for the licensed premises and that application is under review; (

2) If the successor in interest needs additional time to destroy or sell cannabis or cannabis products; or

(3) At the discretion of the Department.

(d) The successor in interest is held subject to all terms and conditions under which a state cannabis license is held pursuant to the Act.

(e) The approval pursuant to subsection (c) creates no vested right to the issuance of a state cannabis license.

§40192. Registration to Operate a Shared-Use Facility.

(a) No licensee shall operate as a shared-use facility without prior approval by the Department.

(b) To register as a shared-use facility, a Type 7, Type 6, or Type N licensee shall submit the following to the Department through MCLS:

(1) A copy of the valid license, permit, or other authorization issued by the local jurisdiction that enables the licensee to operate as a shared-use facility. The Department shall contact the applicable local jurisdiction to confirm the validity of the local authorization Upon receipt of the application for registration, the Department shall contact the applicable local jurisdiction to confirm the validity of the authorization. If the local jurisdiction does not respond within 10 calendar days, the Department shall consider the authorization valid.

(2) A registration form prescribed by the Department, which includes the following information:

(A) The proposed occupancy schedule that specifies the days and hours the common-use area will be available for use by Type S licensees and when the common use area will be used by the primary licensee. The occupancy schedule shall allow for adequate maintenance, cleaning, and sanitizing between uses by individual licensees.

(B) A diagram indicating:

(i) Each designated area for Type S licensee(s).

(ii) The common-use area, including identification of any shared equipment.

(c) The Department shall notify the Type 7, Type 6, or Type N licensee upon approval of the registration to operate as a shared-use facility. The notification shall be made through MCLS.

(d) At least one business day prior to a Type S licensee commencing manufacturing operations at a registered shared-use facility, the primary licensee shall provide written notification to the Department. The notification to the Department shall include the Type S licensee’s business name, contact person, contact phone number, and license number. The primary licensee shall also provide an updated occupancy schedule that includes the Type S licensee and an updated diagram that specifies the Type S licensee’s designated area. A notification shall be provided by email or through MCLS.

(e) A primary licensee that wishes to discontinue operation as a shared-use facility may cancel its registration by providing written notice to the Department and each Type S licensee authorized to use the shared-use facility at least 30 calendar days prior to the effective date of the cancellation.

Authority: Sections 26012; 26013; and 26130, Business and Professions Code. Reference: Sections 26051.5; 26055; and 26130, Business and Professions Code.

Changes to Manufacturing Process Definitions §40230.

DELETED – (a) “Actual yield” means the quantity that is actually produced at any appropriate step of manufacture or packaging of a particular cannabis product. (b) “Adequate” means that which is necessary to accomplish the intended purpose in keeping with good public health practice to ensure cannabis product quality.

ADDED – (d) “Easily cleanable” means a characteristic of a surface that allows effective removal of soil, food residue, or other organic or inorganic materials by normal cleaning methods

DELETED – (i) “In-process material” means any material that is fabricated, compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any other way for use in the manufacture of a cannabis product.

ADDED – (l) “Potable” means water that meets the requirements of Health and Safety Code section 113869.

ADDED – (u) “Smooth” means any of the following: (1) A contact surface that is free of pits, pinholes, cracks, crevices, inclusions, rough edges, and other surface imperfections detectable by visual or tactile inspection. (2) A floor, wall, or ceiling having an even or level surface with no roughness or projections that render it difficult to clean.

ADDED – (v) “Utensil” means an implement, tool, or container used in the storage, preparation, manufacture, or processing of cannabis and cannabis products. In addition to kitchenware, examples of utensils include, but are not limited to, gloves, screens, sieves, implements to create pre-rolls, buckets, and scissors.

DELETED – (v) “Theoretical yield” means the quantity of a particular cannabis product that would be produced at any appropriate step of manufacture or packaging, based upon the number of components or packaging to be used, in the absence of any loss or error in actual production

ADDED – (y) “Yield” means the quantity of a particular cannabis product expected to be produced at a given step of manufacture or packaging, as identified in the master manufacturing protocol. The expected yield is based upon the number of components or packaging to be used, in the absence of any loss or error in actual production. “Actual yield” means the quantity of a particular cannabis product that is actually produced at a given step of manufacture or packaging that is recorded in the batch production record.

Authority: Sections 26012; 26013; and 26130, Business and Professions Code. Reference: Sections 26001; 26120; and 26130, Business and Professions Code.

ADDED -§40235. Quality Control Program

ADDED -§40240. Grounds, Building, and Manufacturing Premises

ADDED – §40243. Equipment and Utensils

ADDED – §40246. Personnel

ADDED – §40248. Cannabis Product Components

ADDED – §40250. General Provisions. Manufacturing Processes and Procedures [SUBSTANTIALLY REVISED]

ADDED – §40253. Product Quality Plan

ADDED – §40255. Master Manufacturing Protocol.

ADDED – §40258. Batch Production Record.

ADDED -§40277. Weights and Measures. – (c) Whenever the licensee is determining the weight, or measurement measure or count of cannabis and cannabis products is determined as for the purposes specified in subsection (a), products the weight, measure, or count shall be weighed determined by a licensed weighmaster, and shall be issued a certificate consistent with the requirements in as required by Chapter 7 (commencing with section 12700) of Division 5 of Business and Professions Code. The weighmaster certificate required under section 12711 of the Business and Professions Code shall not be required when cannabis or cannabis products are weighed for entry into the track-and-trace system.

ADDED – §40290. Waste Management. – SUBSTANTIALLY REVISED

ADDED – §40330. Failed Product Batches. – SUBSTANTIALLY REVISED

ADDED – §40401. Release to Distributor as Finished Product – (a) Prior to the release of a cannabis product to a distributor, a licensee shall ensure that the product is in finished form and is labeled and packaged in its final form for sale. (b) For purposes of this section, “final form” does not include: (1) Labeling of cannabinoid content if the cannabinoid content is to be added to the label at the distribution premises after issuance of the Certificate of Analysis in accordance with section 40409; or (2) Placing the cannabis or cannabis product into child-resistant packaging. This provision shall expire on December 31, 2019.

ADDED – §40403. General Provisions – (1) All of the information specified in Sections 40405 and 40406, for For edible cannabis products, topical cannabis products, suppositories, or orally-consumed concentrates, all of the information specified in Sections 40405 and 40406, except for cannabinoid content. (2) The universal symbol as prescribed in Section 40412, for For inhaled products (e.g., as dab, shatter, and wax), the universal symbol as prescribed in Section 40412.

ADDED – §40405. Primary Panel Labeling Requirements: Manufactured Products – (b) Cannabinoid content may be included on the primary panel. Cannabinoid content for manufactured cannabis products shall be labeled as specified in Section 40409. (bc) Nothing in this section prohibits the inclusion of additional information on the primary panel, provided that the label does not violate the requirements of Section 40410.

ADDED – §40409. Cannabinoid Content Labeling. – SUBSTANTIALLY REVISED

ADDED – §40417. Child-Resistant Packaging Requirements.

(a) Beginning January 1, 2020, a package containing cannabis or cannabis products transferred to a distributor for retail sale shall be child-resistant, as follows:

(1) An edible product, an orally-consumed concentrate, or a suppository shall be child-resistant for the life of the product. A package that contains more than a single serving is not required to be child-resistant if each individual serving is packaged in child-resistant packaging.

(2) Cannabis or a cannabis product intended to be inhaled or a cannabis product that is applied topically may utilize packaging that is child-resistant only until first opened, if the package is labeled with the statement “This package is not child-resistant after opening.”

(b) The following packages are considered child-resistant for purposes of this chapter:

(1) Any package that has been certified as child-resistant under the requirements of the Poison Prevention Packaging Act of 1970 Regulations (16 C.F.R. §1700.15(b)(1)) (Rev. July 1995), which is hereby incorporated by reference.

(2) A bottle sealed with a pry-off metal crown cork style bottle cap, provided that the bottle contains only a single serving.

(3) Plastic packaging that is at least 4 mils thick and heat-sealed without an easy-open tab, dimple, corner, or flap, provided that the package contains a cannabis product described in Subsection (a)(2) or is a cannabis product that is only a single serving.

(c) Until the date specified in subsection (a), the child-resistant package requirement specified in section 26120 of the Act may be met through the use of a child-resistant exit package at retail sale.

Authority: Sections 26012; 26013; and 26130, Business and Professions Code. Reference: Sections 26011.5; 26120; and 26121, Business and Professions Code.

ADDED – §40550. Inspections – (g) The Department may collect evidence related to any alleged violation of the Act or the regulations for the purpose of preserving such evidence during the course of an investigation and any subsequent enforcement proceedings. (h) The Department may copy any materials, books, or records of any licensee or their agents pertaining to the commercial cannabis business.

CDPH-MCSB Proposed Reg. Update

IP, Branding, Licensing

 

 

 

 

 

 

 

Author: abizcannabis

Managing Director & CEO of integrated transactional financial advisory, tax, and technology consulting firm - aBIZinaBOX Inc New York, Chicago, and OaklandCPA.CITP.CISM.CGEIT.CGMAExpertise with: Alt. Investments/Private Equity, Real Estate, Professional Services, CA Cannabis, Tech Start-Ups and Distressed Assets/DebtTechnology Certifications including:Advanced & High Complexity Cloud Integrator AICPA PCPS, CAQ,, IMTA, CITP ISACA CGEIT, CISMState CPA Societies in California, Florida, Illinois, New York and TexasExpertise with Regulatory Compliance - US - HIPAA, FINRA, SEC Rule 17(a)(3)/(4), eDiscovery, FINCEN - EU- EBA, ESMA, EIOPA UK - BoE, PRA, FCA