In this chapter, the following terms have the meanings indicated. Terms Defined. “Acceptable” means agreeable to the use or presence of equipment or a practice when standards are not developed or when developed standards are inappropriate, because the approving authority has determined that the equipment or practice conforms to principles, practices, and generally recognized standards that protect public health. Adulterated. “Adulterated” has the meaning stated in Health-General Article, §§21-207, 21-208, and 21-209, Annotated Code of Maryland. “Adulterated” includes food that: Contains any poisonous or deleterious substance; Is diseased, contaminated, filthy, putrid, or decomposed; or Is otherwise unfit as food for human beings. “Approved source” means a source of food or food ingredients accepted by the Department because the food or food ingredients from the source: Are not adulterated or misbranded; and Where required, are regulated by the approving authority. “Approving authority” means: Within the State, the Secretary of Health or the Secretary's designee; or Outside the State, the agency designated in the laws of another state or country to license or permit a food establishment. “aw” means water activity, which is: The ratio of the water vapor pressure of a food to the vapor pressure of pure water at the same temperature; and An index of the available, free moisture in food. Bake Sale. “Bake sale” means a place where only non-potentially hazardous bakery goods, including breads and pastries, are sold in conjunction with a fundraising event. “Bake sale” does not include a place: Where a person sells baked goods for individual profit; From which food is commercially distributed; or Where a potentially hazardous baked good is sold or distributed. “Barrier” means a physical, biological, or chemical factor that retards or prevents the growth of microorganisms that are infectious or toxigenic. “Base of operations” means a licensed food service facility that is used by the owner or operator of a mobile food service facility for food storage, potable water, safe disposal of waste and sewage, and, if necessary, utensil washing. “Bed and breakfast” means a lodging or rooming house as defined in Public Safety Article, §9-201, Annotated Code of Maryland, that has eight rooms or fewer for rent. “Bona fide nonprofit” means an organization having official documentation from the United States Internal Revenue Service that the organization has current tax-exempt nonprofit status. “Caterer” means a food service facility that: Offers catering services; or Identifies itself as a caterer. “Catering services” means the preparation or provision and the serving of food or drink by a food service facility for service at the provider's premises or elsewhere in connection with a: Specific public event; or Business or social function or affair. “Commercially sterile” means the condition achieved by the: Application of heat, pressure, or other energy or matter that renders a food free of: Microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution; and Viable microorganisms, including spores, that may cause disease; or 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. Comminuted. “Comminuted” means reduced in size by methods including: Chopping; Flaking; Grinding; or Mincing. “Comminuted” includes fish, meat, or a mixture of products that are reduced in size and restructured or reformulated, such as: Gefilte fish; Formed roast beef; The meat used in gyros; Ground beef; and Sausage. “Condiment” means a food or seasoning used to enhance the flavor of another food, including: Mustard; Ketchup; Mayonnaise; Relish; Salt; Pepper; Sugar; or Chutney. “Consumer” means a person who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food service facility or food processing plant, and does not offer the food for resale. “Consumer advisory” means a written notification to consumers that: Identifies food of animal origin that is served or sold as a ready-to-eat food or as an ingredient in a ready-to-eat food that is: Raw; Undercooked; or Not otherwise processed to eliminate pathogens; and Reminds consumers that consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase the risk of foodborne illness, especially if the consumer has certain medical conditions. Continental Breakfast. “Continental breakfast” means a meal that does not require major food preparation as specified in Regulation .28G(1) of this chapter. “Continental breakfast” includes foods such as: Coffee and tea; Juice; Cereal; Milk and cream; Whole fresh fruit; Pastries; Bread; Donuts; Butter and margarine; and Jams and jellies. “Continental breakfast” does not include foods such as: Eggs cooked outside of the shell; Meat; and Fruit salad prepared on premises. “Corrosion resistant” means the property that allows a material to maintain sanitary surface characteristics under the influence of prolonged contact with: Food; Cleaning compounds; Sanitizing solutions; and Other conditions of the environment. “Cottage food business” means a business that: Produces or packages cottage food products in a residential kitchen in Maryland; and Has annual revenues from the sale of cottage food products in an amount not exceeding $50,000. “Cottage food product” means: A non-potentially hazardous food as specified in Regulation .27 of this chapter that is offered for sale: Directly to a consumer from a residence, by personal delivery, by mail delivery, at a farmer’s market, or at a public event; or To a retail food store if the cottage food product remains in the original packaging; and A food that is not offered for sale through interstate commerce. “County of origin” means the county in which the base of operations of a mobile food service facility is located. “Critical control point (CCP)” means a point in the preparation or processing of food where there is a reasonable likelihood that improper control may cause, allow, or contribute to a hazard to public health. Critical Item. “Critical item” means a food safety requirement that if violated requires: Immediate correction; The cessation of some or all processing operations; or Plant closure. “Critical item” includes the following requirements: Obtaining food from an approved source; Protecting food from adulteration, spoilage, and contamination; Restricting food workers with infection or diarrhea in accordance with COMAR 10.06.01; Ensuring that all food workers wash hands thoroughly before touching food and utensils, and as often as needed to prevent food contamination from hand contact; Cooling potentially hazardous foods in accordance with the requirements of this chapter; Holding potentially hazardous foods at the hot and cold temperatures specified in this chapter; Cooking and reheating potentially hazardous foods in accordance with the requirements of this chapter; Providing potable hot and cold running water; and Discharging sewage from the facility in accordance with all applicable State and local codes. “Critical limit” means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to minimize the risk that an identified potential food safety hazard may occur. “Department” means the Maryland Department of Health or the Department's designee. “Detention order” means a written notification by the approving authority to the person-in-charge of a food service facility to detain food that may be adulterated or misbranded, pending a determination of the food's status and disposition in accordance with Health-General Article, §§21-253 and 21-254, Annotated Code of Maryland. “Easily cleanable” means the property of a surface that allows the surface to: Be readily accessible; and Have soil and residue removed by routine cleaning methods. “Egg carton” means a container holding up to 36 shell eggs, including overwrapped cartons and sleeves, that is used to pack shell eggs for distribution or sale to a consumer. “Egg case” means a container that: Is not a carton; Holds either loose shell eggs or cartons of eggs; and Is used to pack shell eggs for distribution or sale to a consumer. “Employee” means: The licensee; An individual having supervisory or management duties; An individual on the payroll; A volunteer; An individual performing work under contractual agreement; or Any other individual working in a food service facility. Equipment. “Equipment” means an item, other than a utensil, that is used in the operation of a food establishment for: Storage; Preparation; Display; Washing; or Transportation. “Equipment” includes a: Stove; Oven; Hood; Slicer; Grinder; Mixer; Scale; Meat block; Table; Food shelf; Refrigerator; Freezer; Sink; Ice maker; or Another item used in the operation of a food service facility. “Equipment” does not include a: Forklift truck; or Dolly. “Excluded organization” means a volunteer fire company or bona fide nonprofit fraternal, civic, war veterans’, religious, or charitable organization or corporation that does not serve food to the public more often than 4 days per week, except that once a year an organization may serve food to the public for up to 30 consecutive days. Farm. “Farm” means a place where agricultural commodities are grown, raised, or harvested for commercial purposes. “Farm” includes a place where, for commercial purposes: Crops are grown and harvested; Fruit, nuts, or other agricultural commodities are harvested from trees; or Animals are raised, fed, and managed for meat or other agricultural commodities. Farmer's Market. “Farmer's market” means a place where a person offers or sells one or more of the following food products directly to the public: Raw agricultural products; Products processed in a private home kitchen, as set forth in Regulation .27 of this chapter; Products that are not potentially hazardous and do not require refrigeration that are processed in a food processing plant licensed and operated according to COMAR 10.15.04.19; or Eggs in compliance with Regulation .05A(8) of this chapter. “Farmer's market” does not include a food service facility. “Food” means: A substance that is used as: Food or drink for human beings; or A component of food or drink for human beings; or Chewing gum or any substance that is a component of chewing gum. “Food-contact surface” means a surface: Of equipment and utensils with which food normally comes in contact; or From which food may drain, drip, or splash onto a: Food; or Surface normally in contact with food. “Food processing plant” has the meaning stated in COMAR 10.15.04.02B. Food Service Facility. “Food service facility” means: A place where food or drink is prepared for sale or service on the premises or elsewhere; or An operation where food is served to or provided for the public with or without charge. “Food service facility” includes: A restaurant, coffee shop, cafeteria, short order cafe, luncheonette, tavern, sandwich stand, soda fountain, retail market, or retail bakery outlet; A food operation in an industry, institution, health care facility, club, school, camp, church, catering kitchen, commissary, or a similar place in which food or drink is prepared for sale or for service on the premises or elsewhere; and A micro market licensed under Business Regulation Article, Title 17, Subtitle 17, Annotated Code of Maryland, and meeting the requirements of this chapter as a food service facility. “Food service facility” does not include a: Facility that offers only prepackaged foods that are not potentially hazardous as specified in §B(55)(c) of this regulation; Kitchen in a private home where food is prepared at no charge for guests in the home, for guests at a social gathering that is not a public event, or for service to unemployed, homeless, or another disadvantaged population; Food preparation or serving area where food is prepared or served only by an excluded organization; Hotel, lodging, or rooming house that serves only a continental breakfast; Farmer’s market or a public event where food products as specified in §B(30)(a) of this regulation are sold; Bake sale where only non-potentially hazardous bakery goods, including breads and pastries, are sold in conjunction with a fundraising event; or Cottage food business. Game Animal. “Game animal” means an animal: That is food for human beings; and That is not classified as cattle, sheep, swine, goat, mule, or other equine. “Game animal” includes: Reindeer; Elk; Deer; Antelope; Water buffalo; Bison; Rabbit; Squirrel; Opossum; Raccoon; Nutria; Muskrat; Bear; and Nonaquatic reptiles such as land snakes. “Game animal” does not include ratites such as: Ostrich; Emu; and Rhea. “Hazard” means a biological, chemical, or physical property that may be detrimental to public health. “Hazard analysis critical control point (HACCP) plan” means a written plan that delineates the procedures for maintaining control of potentially hazardous food at the critical control points of food preparation or processing. Health Care Facility. “Health care facility” means: A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland; A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland; An ambulatory surgical facility or center as defined in Health-General Article, §19-114, Annotated Code of Maryland; An inpatient facility that is organized primarily to help in the rehabilitation of disabled individuals, through an integrated program of medical and other services provided under competent professional supervision; A home health agency, as defined in Health-General Article, §19-401, Annotated Code of Maryland; A hospice facility, as defined in Health-General Article, §19-901, Annotated Code of Maryland; or Another health institution, service, or program for which Health-General Article, §19-114(d)(1)(ix), Annotated Code of Maryland, requires a certificate of need. “Health care facility” does not include the facilities, institutions, and offices set forth in Health-General Article, §19-114(d)(2), Annotated Code of Maryland. “Hermetically sealed container” means a container that: Is secure against the entry of microorganisms; and Maintains the commercial sterility of the contents after processing. “Juice” means: The aqueous liquid expressed or extracted from one or more fruits or vegetables; Purees of the edible portion of one or more fruits or vegetables; or Any concentrate of the liquid or puree as referenced in §B(40)(a) and (b) of this regulation. “License” means the authority to operate a food service facility within the State in accordance with this chapter and Health-General Article, Title 21, Subtitles 1, 2, and 3, Annotated Code of Maryland. “Loose eggs” means shell eggs not contained in a carton. “Lot designation” means a method of marking packed or packaged shell eggs to enable the packer and the approving authority to trace the eggs to the flock that produced the eggs. Major Food Allergen. “Major food allergen” means: Milk; Egg; Fish such as bass, flounder, or cod; Crustacea such as crab, lobster, or shrimp; Tree nuts such as almonds, pecans, or walnuts; Wheat; Peanuts; Soybeans; and A food ingredient that contains protein derived from milk, egg, fish, tree nuts, wheat, peanuts, or soybeans. “Major food allergen” does not include: A highly refined oil derived from a food specified in §B(44)(a) of this regulation and any ingredient derived from a highly refined oil; or An ingredient that is exempt in regard to food allergen labeling requirements under the petition or notification process specified in 21 U.S.C. §343(w)(6) and (7). “Micro market” means an unstaffed, self-checkout retail food service facility that: Includes one or more micro market displays; Has an automated payment kiosk or other device designed to accept electronic payments that is operated by the consumer; Is located indoors and within a separate business; and Is generally accessible only to individuals within the building in which the food service facility is located. “Micro market display” means the place where the food being sold by a micro market is displayed, including: An open rack; A refrigerator or a refrigerated cooler; A freezer; A vending machine; A beverage dispenser; or A single-serve coffee brewer. “Misbranded” has the meaning stated in Health-General Article, §21-210, Annotated Code of Maryland. Mobile Food Service Facility. “Mobile food service facility” means a food service facility that is a mechanically, electrically, manually, or otherwise propelled vehicle operating on land or water that moves as part of its routine operation to: Change location for sales; Obtain food and other supplies; Fill potable water supply holding tanks; Empty wastewater holding tanks; or Provide for the cleaning and sanitization of equipment and utensils. “Mobile food service facility” does not include a food service facility that is able to be moved but does not move routinely for a purpose set forth in §B(46)(a) of this regulation. “Mobile reciprocity license” means a license issued to a mobile food service facility that: Is operating in the jurisdiction; Is operating within 90 miles of its base of operations; and Holds a valid license from the county of origin. “Non-potentially hazardous food” means food named or described in §B(55)(c) of this regulation. “On-farm food service facility” means a temporary food service facility that: Is located on a farm; Serves only those foods approved by the Department, based on a: Review of the facility, equipment, and processing hazards; and Determination that these foods can be prepared safely and in a manner that conforms to applicable laws and regulations; and Operates during a period of time of not more than 30 consecutive days with up to two renewals in a 1-year period. “Package” means a bottle, can, carton, bag, or wrapped container. “Packer” means a person who places shell eggs in the original case, carton, or container that is used to hold eggs for: Distribution; or Sale to a consumer. “Person” has the meaning stated in Health-General Article, §§1-101 and 21-101, including: An operator of a facility that is owned by the State or local unit of government; or A State or local unit of government if the State or local unit of government is the operator of the facility. “Person-in-charge” means: The licensee; or Another person responsible for the operation of a food service facility. “pH” means the symbol for the negative logarithm of the hydrogen ion concentration in gram equivalents per liter of solution where: pH values from 0 to 7 indicate acidity; pH values from 7 to14 indicate alkalinity; and The pH value for pure distilled water, regarded as neutral, is 7. “Portable” means that equipment: Can be easily moved because the equipment is: Small in size and weighs 80 pounds or less; Mounted on casters, gliders, or rollers; or Provided with a mechanical means of safely tilting for cleaning; and Has one of the following: No utility connection; A utility connection that disconnects quickly; or A flexible utility connection line long enough to permit the equipment to be moved for thorough cleaning. Potentially Hazardous Food. “Potentially hazardous food” means a natural or synthetic food that requires temperature control because the food is in a form capable of supporting: The rapid and progressive growth of infectious or toxigenic microorganisms; The growth and toxin production of Clostridium botulinum; or In raw shell eggs, the growth of Salmonella Enteritidis. “Potentially hazardous food” includes: A food of animal origin that is raw or heat-treated; A food of plant origin that is heat-treated; Raw seed sprouts; Cut melons; Cut raw tomatoes; Garlic and oil mixtures that support growth as specified in §B(55)(a)(i) and (ii) of this regulation; and Cut leafy greens. “Potentially hazardous food” does not include a: Hard-boiled shell egg that has been air-cooled with the shell intact; Food with an aw value of 0.85 or less; Food with a pH level of 4.6 or below when measured at 75°F; Commercially sterile food in a hermetically sealed container; or Food for which laboratory evidence demonstrates that the rapid and progressive growth of infectious and toxigenic microorganisms or the growth of Salmonella Enteritidis in eggs or Clostridium botulinum cannot occur, such as a food that has an aw or a pH that is above the levels specified in §B(55)(c)(ii)and(iii) of this regulation or that may contain a preservative, other barrier to the growth of microorganisms, or a combination of barriers that inhibit the growth of microorganisms. “Poultry” means a: Domesticated bird whether live or dead including a: Chicken; Turkey; Duck; Goose; Guinea; Ratite; or Squab; and Migratory waterfowl or game bird whether live or dead, including a: Pheasant; Partridge; Quail; or Grouse. “Premises” means the physical food service facility and the contiguous land or property under the control of the operator or the licensee. “Principal display panel” means the part of a container that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. “Priority assessment” means an evaluation of risk in a food service facility using the parameters established by the Department in Regulation .33C of this chapter. Public Event. “Public event” means an event or festival that is a planned gathering that is: Open to the public; and Regulated by the State or local jurisdiction in which the planned gathering takes place. “Public event” includes an event or festival: Attended by individuals from the general public whether or not a fee is charged; or Advertised with fliers, banners, newspaper articles, radio or television announcements, or on an Internet website as being open to the public. “Public event” does not include a: Private party; An event restricted to organization members; or Another event that restricts the general public from attending. “Raw agricultural product” means a whole, unprocessed agricultural product supplied directly from the farm on which it was produced, including: Grains; Flowers; Herbs; Nuts; Fruits; Vegetables; and Honey. Ready-to-Eat Food. “Ready-to-eat food” means food in a form that is edible without washing, cooking, or additional preparation by the food service facility or the consumer. “Ready-to-eat food” includes: Potentially hazardous food that is cooked to the temperature and time required for a specific food as set forth in Regulation .10 of this chapter; Raw fruits and vegetables that are washed and cut; Whole, raw fruits and vegetables that are presented for consumption without need for further washing, such as at a buffet; and A food presented for consumption for which further washing or cooking is not required and from which rinds, peels, husks, or shells are removed. “Reconditioned” means reprocessing a food using an approved method that results in a food that is safe, wholesome, and free from contamination. “Reconstituted” means water or other liquid has been restored to a food that was previously dehydrated. Reduced Oxygen Packaged. “Reduced oxygen packaged” means that a food was packaged so that the amount of oxygen in the package is below that found in the surrounding atmosphere due to the: Mechanical evacuation of oxygen; Displacement of oxygen with one or more gases; or Reduction of the oxygen content by other means. “Reduced oxygen packaged” includes food that is: Vacuum packaged; Modified atmosphere packaged; and Controlled atmosphere packaged. “Refrigerated food” means a food that: Is not shelf stable; Must be refrigerated to: Retard the growth of spoilage or pathogenic microorganisms; and Prevent the production of microbial toxins; or Is labeled by the manufacturer with a statement indicating that the product is to be kept refrigerated. “Registration” means the process by which the Maryland Department of Agriculture grants the authority to a packer within the State to provide shell eggs for human consumption. “Registration number” means the number that the Maryland Department of Agriculture assigns a packer. “Retail food manufacturing” means the manufacturing of food in a food service facility for wholesale distribution. Retail Food Store. “Retail food store” means a licensed food service facility that sells prepackaged food items either fresh, refrigerated, frozen, or shelf-stable. “Retail food store” includes a grocery store, convenience store, retail market, retail bakery, or food cooperative. “Retail food store” does not include a restaurant, mobile food service facility, coffee shop, cafeteria, short order café, luncheonette, tavern sandwich shop, produce stand that only offers whole, uncut fresh fruits and vegetables, or establishment that offers only pre-packaged non-potentially hazardous foods. “Sanitization” means a heat or chemical treatment on cleaned food contact surfaces that is sufficient to yield a 99.999 percent reduction of the number of representative disease microorganisms of public health significance. “Seasonal farmer’s market producer sampling food service facility” means a facility that: Serves only foods that are prepared and offered as samples by a producer of a farm product at a farmer’s market or a public event, such as: Farm products as specified in §B(30)(a) of this regulation; or Farm products that have been inspected, licensed, or certified for food safety by the Maryland Department of Agriculture; Serves food only produced by the licensee; Serves only those foods approved by the Department, based on a: Review of the facility, equipment, and processing hazards; and Determination that these foods can be prepared safely and in a manner that conforms to applicable laws and regulations; and Operates during a period of time of not more than a 1-year period from the date of issuance or renewal of the license. “Secretary” means the Secretary of Health or the Secretary's designee. “Semi-permanent food service facility” means a facility that: Is built at a location other than where it operates; Is transported as a complete unit that does not require a building permit to install on the location at which it operates; Has no indoor seating for patrons; When serving cooked food, serves only foods cooked for immediate service; and Is not a mobile food service facility as specified in §B(46) of this regulation. “Service animal” has the meaning stated in Human Services Article, §7-701, Annotated Code of Maryland. “Shell eggs” means raw eggs produced by chickens for human consumption. “Shellfish” means all species of: Oysters, clams, or mussels, whether: Shucked or in the shell; Raw, including post-harvest processed; Frozen or unfrozen; and Whole or in part; and Scallops in any form, except when the final product is the adductor muscle only. Single Service Article. “Single service article” means an article designed, fabricated, and intended for one-time consumer use. “Single service article” includes a: Utensil; Cup; Plate; Stirrer; Napkin; Straw; Toothpick; Food container; Place mat; Food package; or Similar item. Single Use Article. “Single use article” means an article intended by the manufacturer for one-time use by the preparer of the food. “Single use article” includes a: Bulk food container; Utensil; Formed aluminum pie pan; Jar; Plastic bucket; or Similar item. Special Food Service Facility. “Special food service facility” means a food service facility for which the Department provides exceptions to certain regulations because of the nature of one or more of the following: Design and operation of the facility; Food preparation or service methods; or Limited length of time that the facility operates in association with special events. “Special food service facility” includes: A bed and breakfast that serves hot meals; A mobile unit; A temporary food service facility; A semi-permanent food service facility; An on-farm food service facility; or A seasonal farmer’s market producer sampling food service facility. Tableware. “Tableware” means multi-use eating, drinking, and serving utensils. “Tableware” includes: Knives; Forks; Spoons; Bowls; Cups; Serving dishes; Tumblers; and Plates. “Temporary food service facility” means a food service facility that operates at a fixed location for up to 30 consecutive days in conjunction with a: Fair; Carnival; Public exhibition; Construction project; Recreational facility; Fundraising event; or Similar gathering. “Time-only” means using time instead of time in conjunction with temperature as the sole means of food protection for a potentially hazardous food. “Undercooked” means a potentially hazardous food that is not cooked to the minimum internal temperature and for the specified holding time specified in Regulation .10A of this chapter. “Utensil” means tableware or a food-contact implement used in the storage, preparation, dispensing, or serving of food. “Vending machine” means a self-service device that dispenses either packaged or unpackaged food. “Warewashing” means the cleaning and sanitizing of food-contact surfaces of equipment or utensils. Whole Muscle, Intact Beefsteak. “Whole muscle, intact beefsteak” means a beefsteak cut from whole muscle beef that has not been penetrated in a way that may allow infectious or toxigenic microorganisms to be introduced into the interior of the meat. “Whole-muscle, intact beefsteak” does not include meat that has been: Injected; Mechanically tenderized; Reconstructed; or Scored.