Md. Code Regs. 10.62.37.01

Current through Register Vol. 51, No. 7, April 5, 2024

Section 10.62.37.01 - Definitions

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) "Approved source" means a source of:

(a) Medical cannabis approved, licensed, and regulated by the Commission; or

(b) Food ingredients regulated by an approving authority.

(2) "Approving authority" means the agency designated in the laws of Maryland, another state, or another country to license or permit a food processing plant.

(3) "Commercially sterile" means the condition achieved by the:

(a) Application of heat, pressure, or other energy or matter that renders a food ingredient free of:

(i) Microorganisms capable of reproducing in the food ingredient under normal non-refrigerated conditions of storage and distribution; and

(ii) Viable microorganisms, including spores, that cause disease; or

(b) Control of water activity and the application of heat, pressure, or other energy or matter that renders the food ingredient free of microorganisms capable of reproducing in the food ingredient under normal non-refrigerated conditions of storage and distribution.

(4) "Cookware" means items used during the processing of ingredients or edible cannabis products, including pots, pans, utensils, and containers.

(5) "Critical control point" means a point in the receiving, storage, processing, or distribution of ingredients or edible cannabis products where there is a reasonable likelihood that improper control may cause, allow, or contribute to a hazard to public health.

(6) Critical Item.

(a) "Critical item" means a safety requirement that if violated requires:

(i) Immediate correction;

(ii) Destruction of any ingredients or edible cannabis products which may be affected;

(iii) The cessation of some or all processing operations; or

(iv) Closure of the licensed premises.

(b) "Critical item" includes the following requirements:

(i) Food ingredients be obtained from an approved source and approved for human consumption by an approving authority;

(ii) Cannabis ingredients be obtained from an approved source;

(iii) All ingredients and edible cannabis products be protected from contamination;

(iv) All processes provide safe edible cannabis products with proper control at critical control points;

(v) Licensed processor sanitation be adequate, provide safety, and prevent illness transmissible through edible cannabis products or ingredients;

(vi) Equipment allows for proper processing and sanitation;

(vii) Edible cannabis products be packaged and labeled for safety;

(viii) A sufficient volume of potable hot and cold water supply under adequate pressure be available to facilitate proper handwashing procedures outlined in this chapter; and

(ix) Sewage be discharged in compliance with applicable laws and regulations.

(7) "Food" means any substance that is used as food or drink for human beings or as a component of food or drink for human beings.

(8) "Food ingredient" means a substance that is used as a component of food, including:

(a) Flavoring;

(b) Food coloring; and

(c) Preservatives.

(9) "Ingredient" means any component of an edible cannabis product that is intended for human consumption, approved by the Commission, and composed of:

(a) Food or food ingredients; or

(b) Medical cannabis.

(10) "Permit" means a permit issued by the Commission to a licensed processor for the purpose of manufacturing edible cannabis products.

(11) "Permittee" means a licensed processor authorized by the Commission to manufacture edible cannabis products.

(12) Potentially Hazardous Edible Cannabis Product.

(a) "Potentially hazardous edible cannabis product" means an edible cannabis product that requires temperature control because the product is in a form capable of supporting:

(i) The rapid and progressive growth of infectious or toxigenic microorganisms; or

(ii) The growth and toxin production of Clostridium botulinum.

(b) "Potentially hazardous edible cannabis product" does not include products with a water activity (aw) value of 0.85 or less.

(13) Potentially Hazardous Ingredient.

(a) "Potentially hazardous ingredient" means a natural or synthetic component of food or an edible cannabis product intended for human consumption that requires temperature control because the ingredient is in a form capable of supporting the:

(i) Rapid and progressive growth of infectious or toxigenic microorganisms; or

(ii) Growth and toxin production of Clostridium botulinum.

(b) "Potentially hazardous ingredient" does not include an ingredient with a:

(i) Water activity (aw) value of 0.85 or less;

(ii) pH level of 4.6 or below when measured at 75°F; or

(iii) Commercially sterile ingredient in a hermetically sealed container.

(14) "Quarantine area" means an area within a licensed premise in which ingredients, medical cannabis, or medical cannabis finished products that may be contaminated are temporarily stored prior to disposal or collection by a public health agency.

Md. Code Regs. 10.62.37.01

Regulation .01 adopted effective 48:8 Md. R. 309, eff. 4/19/2021