Section 17207 - Manufacturing Practices DefinitionsIn addition to the definitions in section 26001 of the Act and section 15000 of this division, the following definitions shall govern the construction of this chapter:
(a) "Allergen cross-contact" means the unintentional incorporation of a food allergen into a cannabis product.(b) "Component" means any substance or item intended for use in the manufacture of a cannabis product, including those substances or items that are not intended to appear in the finished cannabis product. "Component" includes cannabis, cannabis products used as ingredients, raw materials, other ingredients, and processing aids.(c) "Contact surface" means any surface that contacts cannabis products and cannabis product components and those surfaces from which drainage, or other transfer, onto the cannabis product or cannabis product components, occurs during the normal course of operations. Examples of contact surfaces include containers, utensils, tables, and equipment.(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.(e) "Environmental pathogen" means a pathogen capable of surviving and persisting within the manufacturing environment such that cannabis products may be contaminated and may result in illness if consumed or used without treatment to significantly minimize the environmental pathogen. Examples of environmental pathogens include Listeria monocytogenes and Salmonella spp. but do not include the spores of pathogenic spore-forming bacteria.(f) "Hazard" means any biological, chemical, radiological, or physical agent that has the potential to cause illness or injury.(g) "Holding" means storage of cannabis or cannabis products and includes activities performed incidental to storage of a cannabis product and activities performed as a practical necessity for the distribution of that cannabis product.(h) "Microorganisms" means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species that are pathogens. The term "undesirable microorganisms" includes those microorganisms that are pathogens, that subject a cannabis product to decomposition, that indicate that a cannabis product is contaminated with filth, or that otherwise may cause a cannabis product to be adulterated.(i) "Monitor" means to conduct a planned sequence of observations or measurements to assess whether preventive measures are operating as intended.(j) "Pathogen" means a microorganism that can cause illness or injury.(k) "Potable" means water that meets the requirements of Health and Safety Code section 113869.(l) "Preventive measures" means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified pursuant to a product quality plan as specified in section 17214.(m) "Processing aid" means any substance that is added to a cannabis product during manufacture but is removed in some manner from the cannabis product before it is packaged in its finished form. This includes substances that are converted into constituents normally present in the product, and do not significantly increase the amount of the constituent naturally found in the product. This also includes substances that are added to a product for their technical or functional effect in the processing but are present in the finished product at insignificant levels and do not have any technical or functional effect in that product.(n) "Qualified individual" means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture quality cannabis products as appropriate to the individual's assigned duties. A qualified individual may be, but is not required to be, an employee of the licensed manufacturer.(o) "Quality control" means a planned and systematic operation or procedure for ensuring the quality of a cannabis product.(p) "Quality control operation" means a planned and systematic procedure for taking all actions necessary to prevent cannabis product(s) from being adulterated or misbranded.(q) "Quality control personnel" means any person, persons, or group designated by the licensed manufacturer to be responsible for quality control operations.(r) "Raw material" means any unprocessed material in its raw or natural state that is intended to become part of the components of a cannabis product.(s) "Sanitize" means to treat cleaned surfaces by a process that is effective in destroying vegetative cells of pathogens and substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.(t) "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.(u) "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.(v) "Validate" means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or set of quality control procedures, when properly implemented, is capable of ensuring the quality of a cannabis product or effectively controlling an identified hazard.(w) "Verification" means the application of methods, procedures, tests, or other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the quality control procedures.(x) "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 quantity 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.Cal. Code Regs. Tit. 4, § 17207
1. New article 4 (sections 17207-17218) and section filed 9-27-2021 as an emergency; operative 9-27-2021 (Register 2021, No. 40). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 3-28-2022 or emergency language will be repealed by operation of law on the following day.
2. New article 4 (sections 17207-17218) and section refiled 3-28-2022 as an emergency; operative 3-28-2022 (Register 2022, No. 13). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 9-26-2022 or emergency language will be repealed by operation of law on the following day.
3. Certificate of Compliance as to 3-28-2022 order, including amendment of first paragraph, transmitted to OAL 9-26-2022 and filed 11-7-2022; amendments effective 11-7-2022 pursuant to Government Code section 11343.4(b)(3) (Register 2022, No. 45). Note: Authority cited: Sections 26013 and 26130, Business and Professions Code. Reference: Sections 26001 and 26130, Business and Professions Code.
1. New article 4 (sections 17207-17218) and section filed 9-27-2021 as an emergency; operative 9/27/2021 (Register 2021, No. 40). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 3-28-2022 or emergency language will be repealed by operation of law on the following day.
2. New article 4 (sections 17207-17218) and section refiled 3-28-2022 as an emergency; operative 3/28/2022 (Register 2022, No. 13). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 9-26-2022 or emergency language will be repealed by operation of law on the following day.
3. Certificate of Compliance as to 3-28-2022 order, including amendment of first paragraph, transmitted to OAL 9-26-2022 and filed 11/7/2022; amendments effective 11/7/2022 pursuant to Government Code section 11343.4(b)(3) (Register 2022, No. 45).