10.15.04.02

.02 Definitions.

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

B. Terms Defined.

(1) Adulterated Food.

(a) "Adulterated food" has the meaning stated in Health-General Article, §21-207, Annotated Code of Maryland.

(b) "Adulterated food" includes food that is:

(i) Spoiled;

(ii) Contaminated; or

(iii) Misbranded so that the food is unsafe for human consumption.

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

(3) "Approved source" means a source of food or food ingredients accepted by the Department because the food or food ingredients from the source:

(a) Are not adulterated or misbranded as defined in §B(1) and (19) of this regulation; and

(b) Where required, are regulated by the approving authority.

(4) "Charity deer processing" means the processing of legally harvested whitetail deer into cuts of raw meat as only a service for a charitable organization that donates the meat to the needy for consumption.

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

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

(i) Microorganisms capable of reproducing in the food under normal nonrefrigerated 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 free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.

(6) "Contamination" means:

(a) Microbiological, chemical, radiological, or physical substances that are capable of causing a food to be adulterated; or

(b) The result of adding the substances described in §B(5)(a) of this regulation to a food or food contact surface.

(7) "Critical control point" means a point in the processing of food where there is a reasonable likelihood that improper control may cause, allow, or contribute to a hazard to public health.

(8) "Critical factor" means a property, characteristic, condition, aspect, or other parameter, which, if varied, may affect a scheduled process.

(9) Critical Item.

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

(i) Immediate correction;

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

(iii) Plant closure.

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

(i) Food is obtained from an approved source;

(ii) Food is protected from contamination and adulteration;

(iii) Food processes provide safe food with proper control at critical control points;

(iv) Food worker sanitation provides food safety with effective hand washing and the absence of illness transmissible through food;

(v) Food equipment allows proper processing and sanitation;

(vi) Food is packaged and labeled for safety;

(vii) A sufficient volume of potable hot and cold water supply under pressure is available; and

(viii) Sewage is discharged in compliance with applicable laws and regulations.

(10) "Department" means the Maryland Department of Health or the Department's designee.

(11) "Dry packaged food" means a nonperishable food that is:

(a) Not refrigerated; and

(b) Either:

(i) Dry food in a package; or

(ii) Liquid food in a watertight package.

(12) Farm.

(a) "Farm" means a place where agricultural commodities are grown, raised, or harvested for commercial purposes.

(b) "Farm" includes a place where, for commercial purposes:

(i) Crops are grown and harvested;

(ii) Fruit, nuts, or other agricultural commodities are harvested from trees; or

(iii) Animals are raised, fed, and managed for meat or other agricultural commodities.

(13) "Food" means:

(a) A substance that is used as food or drink for human beings or as a component of food or drink for human beings; or

(b) Chewing gum or any substance that is a component of chewing gum.

(14) Food Processing Plant.

(a) "Food processing plant" means a place used for or in connection with commercial food:

(i) Manufacturing;

(ii) Preparing;

(iii) Processing;

(iv) Packaging;

(v) Canning;

(vi) Freezing;

(vii) Storing;

(viii) Distributing;

(ix) Labeling; or

(x) Holding.

(b) "Food processing plant" includes a:

(i) Bakery plant;

(ii) Cannery;

(iii) Confectionery plant;

(iv) Crab meat picking plant;

(v) Food manufacturing plant;

(vi) Food warehouse;

(vii) Food distribution center;

(viii) Frozen food processing plant;

(ix) Ice manufacturing plant;

(x) Shellfish plant or dealer;

(xi) Soft drink manufacturing plant;

(xii) Bottled water plant;

(xiii) Food transfer station;

(xiv) Meat processing plant or poultry processing plant that is not subject to regulation by the United States Department of Agriculture or by a meat inspection program or poultry inspection program administered by the Maryland Department of Agriculture;

(xv) Cider plant;

(xvi) Charity deer processing plant; and

(xvii) Producer mobile farmer’s market unit.

(c) "Food processing plant" does not include a warehouse or distribution center that:

(i) Does not process food; and

(ii) Stores only sealed containers of water, ice, whole bean, ground or instant coffee, leaf or instant teas, nondairy dehydrated whiteners, sugar, or sugar-free sweeteners.

(15) “Food transfer station” means a food processing plant where:

(a) Food is transferred between transportation vehicles; and

(b) There is an area maintained for food storage.

(16) "Generally recognized as safe (GRAS)" means that a substance is:

(a) Not harmful to humans consuming the substance under the intended conditions of use; and

(b) In accordance with 21 CFR §170.30.

(17) "HACCP plan" means a Hazard Analysis Critical Control Point (HACCP) as specified by:

(a) COMAR 10.15.10;

(b) COMAR 10.15.12;

(c) 21 CFR Part 123; or

(d) The National Advisory Committee on the Microbiological Criteria for Food.

(18) "Label" means a display of written or graphic matter on the container, other than the package liner, of a food.

(19) "Labeling" means any label or other written or graphic material that:

(a) Is on a:

(i) Food;

(ii) Food container; or

(iii) Food wrapping; or

(b) Accompanies a food.

(20) "Misbranded" has the meaning stated in Health-General Article, §21-210, Annotated Code of Maryland.

(21) "Morgue area" means an area within a food processing plant in which food that is adulterated is temporarily stored awaiting disposition.

(22) "Person-in-charge" means:

(a) The licensee; or

(b) Another person responsible for the operation of the food processing plant.

(23) Potentially Hazardous Food.

(a) "Potentially hazardous food" means a natural or synthetic food that requires temperature control because the food is in a form capable of supporting:

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

(ii) The growth and toxin production of Clostridium botulinum; or

(iii) In raw shell eggs, the growth of Salmonella Enteritidis.

(b) "Potentially hazardous food" does not include a food 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 food in a hermetically sealed container.

(24) "Poultry" means a domesticated bird whether dead or alive.

(25) "Principal display panel" means the part of a label that is the most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.

(26) "Process" means:

(a) An operation involved in commercial food manufacturing and distribution, including the operations set forth in §B(13)(a) of this regulation; or

(b) A specific set of operations or procedures used to manufacture a food.

(27) "Process authority" means an individual having knowledge acquired through training and experience with a food process.

(28) Producer Mobile Farmer’s Market Unit.

(a) “Producer mobile farmer’s market unit” means a unit designed to ensure that food is:

(i) Protected from contamination during transportation from farm to farmer’s market or public festival or event; and

(ii) Kept at temperatures that support the safety and wholesomeness of the food.

(b) “Producer mobile farmer’s market unit” does not include a unit used to deliver:

(i) Prepackaged foods to fill an order of a customer;

(ii) Raw agricultural products; or

(iii) Non-potentially hazardous on-farm home processed foods.

(29) "Public festival or event" means a planned gathering that is open to the public and is regulated by the State or local jurisdiction where the public festival or event takes place.

(30) "Reduced oxygen package" means a food package in which the amount of oxygen in the package is below that found in the surrounding atmosphere due to the:

(a) Mechanical evacuation of oxygen;

(b) Displacement of oxygen with one or more other gases; or

(c) Reduction of the oxygen content by other means.

(31) "Scheduled process" means a method or set of procedures determined by a process authority for processing a food, which takes into account the critical factors that may impact the food's safety or stability.

(32) "Shelf life study" means a food evaluation using microbiological, physical, chemical, organoleptic, or other tests to determine the length of time a food may be stored before the food becomes unfit for sale or human consumption.

(33) "Shell eggs" means raw eggs produced by chickens for human consumption.

(34) "Vending machine" means a machine that dispenses or provides food to a consumer.