The Grade “A” Pasteurized Milk Ordinance, 2015 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), Item 10p., Item 11p., Appendix H, Appendix I, and Appendix N only, is incorporated by reference. Ice cream and frozen custard are the foods prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.110, Ice Cream and Frozen Custard. Ice milk is the food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.120, Ice Milk. Ice milk shall be offered for sale, sold, or served only in properly labeled factory-filled containers, if the ice milk or any of its ingredients contain added color or any ingredients added for the purpose of imparting a characterizing flavor, except that ice milk may be served and sold at retail from a dispensing freezer. When ice milk is sold at retail, direct from a frozen dessert dispensing freezer, a sign shall be prominently and conspicuously displayed, where it can be clearly read by customers under normal conditions of purchase, stating “Ice Milk Sold Here”. The letters on the sign shall be bold-face capitals at least 3 inches high and in contrasting color to the background. When ice milk is sold at retail, only in properly labeled factory-filled containers, this sign is not required. Mellorine is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.130, Mellorine. Mellorine shall be sold, held, offered for sale only in factory-filled containers. Sherbet is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.140, Sherbet. Water ices are the foods each of which is prepared from the ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21, Food and Drugs, Part 135.160, Water Ices. Description. Goat milk ice cream is the food prepared from the same ingredients and in the same manner, including the requirements for label statements of optional ingredients, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.110, Ice Cream and Frozen Custard, except that all milkfat and nonfat milk solids shall be derived from goat milk. Nomenclature. The name of the food is “goat milk ice cream”. Label Declaration. On the label, in the name of the food, the letters in the words, “goat milk” shall be the same size, type, and color, and on the same contrasting background as the letters in the words “ice cream”. Description. Goat milk ice milk is the food prepared from the same ingredients and in the same manner, including the requirements for label statements of optional ingredients, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.120, Ice Milk, except that all milkfat and nonfat milk solids shall be derived from goat milk. Nomenclature. The name of the food is “goat milk ice milk”. Label Declaration. On the label, in the name of the food, the letters in the words, “goat milk” shall be the same size, type, and color, and on the same contrasting background as the letters in the words, “ice milk”. Description. Frozen yogurt is the food prepared by freezing while stirring a pasteurized mix consisting of the same ingredients permitted for ice cream in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.110. These ingredients are cultured after pasteurization by one or more strains of Lactobacillus bulgarius and streptococcus thermophilus, provided, however, fruits, nuts or other flavoring materials may be added before or after the mix is pasteurized and cultured. Bacteria and coliform requirements for frozen yogurt shall apply to the mix before culturing. Coliform requirements for frozen yogurt shall apply to the mix after culturing. Frozen yogurt, exclusive of any flavoring, shall contain not less than 3.25 percent milkfat and not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than the result of bacterial activity, shall be applied to the product after culturing. No heat or bacteriostatic treatment (other than refrigeration), which results in the total destruction of the microorganisms, may be applied to the product after culturing. The finished yogurt shall weigh not less than 5 pounds per gallon. Nomenclature. The name of the food is “frozen yogurt”. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Description. Lowfat frozen yogurt is the food prepared from the same ingredients and in the same manner prescribed in Regulation .08 of this chapter. Lowfat frozen yogurt, exclusive of any flavorings, shall contain not less than .5 percent or more than 2.0 percent milkfat and not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than .5 percent expressed as lactic acid. Nomenclature. The name of the food is “lowfat frozen yogurt”. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Description. Nonfat frozen yogurt is the food prepared from the same ingredients and in the same manner prescribed in Regulation .08 of this chapter. Nonfat frozen yogurt, exclusive of any flavorings, shall contain less than .5 percent milkfat. Nomenclature. The name of the food is “nonfat frozen yogurt”. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Description. Quiescently frozen confection means the frozen product made from sweetening agents, harmless natural or artificial flavoring, and water, and it may contain milk solids, harmless coloring, organic acids, and any safe and suitable functional ingredient approved by the Secretary. The finished product shall contain not less than 17 percent by weight of total food solids. In the manufacture of this product, freezing has not been accompanied by stirring or agitation (generally known as quiescent freezing). In the production of this quiescently frozen confection, no processing or mixing before quiescent freezing may be used that develops in the finished confection mix any physical expansion in excess of 10 percent. This confection shall be manufactured in the form of servings, individually packaged, bagged, or otherwise wrapped, properly labeled, and purveyed to the consumer in its original factory-filled package. The individually wrapped confection need not be labeled if it is contained in a multiple package which is properly labeled and purveyed unopened to the consumer. Nomenclature. The name of the food is “quiescently frozen confection”. Labeling. In addition to all other required information, the label shall comply with the applicable regulations promulgated under the Code of Federal Regulations, Title 21 Food and Drugs. Description. Quiescently frozen dairy confection means the frozen product made from milk products, sweetening agents, harmless natural or artificial flavoring, and water, and it may contain harmless coloring, and any safe and suitable functional ingredient approved by the Secretary. The finished product contains not less than 33 percent by weight of total food solids. In the manufacture of this product, freezing has not been accompanied by stirring or agitation (generally known as quiescent freezing). In the production of this quiescently frozen dairy confection, no processing or mixing before quiescent freezing may be used that develops in the finished confection mix any physical expansion in excess of 10 percent. This confection shall be manufactured in the form of servings, individually packaged, bagged, or otherwise wrapped, properly labeled, and purveyed to the consumer in its original factory-filled package. The individually wrapped confection need not be labeled if it is contained in a multiple package which is properly labeled and purveyed unopened to the consumer. Nomenclature. The name of the food is “quiescently frozen dairy confection”. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Description. Frozen dietary dairy dessert means a frozen dessert prepared for persons who wish to restrict their intake of ordinary sweetening ingredients. It is produced by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Regulation .01-1 of this chapter. The minimum fat content shall be 3 percent, it shall contain no sugars other than those naturally present in the milk solids or flavoring agents which have been added to it, and it may contain edible carbohydrates other than sugars. The edible carbohydrates must be approved by the Department. The product may not be sold in any manner other than in sealed or unbroken packages or containers. Nomenclature. The name of the food is “frozen dietary dairy dessert”. Labeling. Immediately preceding or following the name of the product, there shall be a statement as follows: “Contains ___% milkfat”. The blank is to be filled in with the percentage of milkfat in the product. The label of frozen dietary dairy dessert shall contain the statement: “Diabetics: This product may be useful in your diet on the advice of a physician. This food is not a reduced calorie food.” In addition to all other required information, the label shall comply with the applicable regulations promulgated under the Code of Federal Regulations, Title 21 Food and Drugs. Description. Dietary frozen dessert or lowfat frozen dairy dessert is the food prepared by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Regulation .01-1 of this chapter. The finished product contains less than 2 percent by weight of ether extractable fat: its content of total milk solids is not less than 7 percent by weight. The product weighs no less than 4.5 pounds per gallon and the quantity of food solids per gallon is not less than 1.1 pounds or more than 1.9 pounds, exclusive of any microcrystalline cellulose used as an ingredient. One or more vitamins or minerals, or both, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.9 may be added to the product. If vitamins or minerals, or both, are added, each 4-fluid-ounce serving of finished product shall provide not less than 8 percent or more than 20 percent of the U. S. Recommended Daily Allowance of these vitamins or minerals, or both. Dietary frozen dessert or lowfat frozen dairy dessert may be sold in properly labeled factory-filled containers, except it may be sold directly from a dispensing freezer at the time of a direct request from a customer. When sold directly from a dispensing freezer, each container shall be labeled with the name of the product and with the name of the product and with nutritional and ingredient information as prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Nomenclature. The name of the food is “dietary frozen dessert” or “lowfat frozen dairy dessert”. Labeling. If vitamins or minerals, or both, are added, the name of the food on the principal display panel and each alternate principal display panel shall be immediately preceded or followed by the word “fortified” in the same style and at least one-half the size of the type used for the name “dietary frozen dessert” or “lowfat frozen dairy dessert” and on the same contrasting background. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Description. Non-fruit sherbet is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.140 Sherbet, except that the food may not contain any fruit or fruit juice. Nomenclature. The name of the food is “Non-fruit ___ Sherbet”. The blank is to be filled in by the characterizing flavor used. Labeling. The label shall contain the following statement: “Imitation ___ Sherbet”, the blank to be filled in by the characterizing flavor used. The letters in the word “imitation” shall be the same size, type, and color and on the same contrasting background as the name of the characterizing flavor and the word, sherbet. The statement in §C(1), of this regulation, shall be followed immediately by the words, “contains no fruit or fruit juice” in letters at least half the size of the words used in the statement. When a sign is used at the point of purchase to advertise the product, it shall contain the same information prescribed in §C(1) and (2), of this regulation. Description. Non-fruit water ice is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.160 Water Ices, except that the food may not contain any fruit or fruit juice. The finished non-fruit water ice weighs not less than 6 pounds per gallon. Nomenclature. The name of the food is “Non-fruit ___ Water Ice”. The blank is to be filled in by the characterizing flavor used. Labeling. The label shall contain the following statement: “Imitation ___ Ice”. The blank is to be filled in by the characterizing flavor used. The letters in the word imitation shall be the same size, type, and color and on the same contrasting background as the name of the characterizing flavor and the word, ice. The statement in §C(1), of this regulation, shall be followed immediately by the words, “contains no fruit or fruit juice”, in letters at least half the size of the words used in the statement. When a sign is used at the point of purchase to advertise the product, it shall contain the same information prescribed in §C(1) and (2), of this regulation. Description. “Manufactured desserts mix”, whipped cream confection, bisque tortoni, means a frozen dessert made with milk products, sweetening agents, flavoring agents, with or without harmless coloring or any other safe and suitable ingredients approved by the Secretary. It contains not less than 18 percent by weight of milkfat, and not more than 12 percent of milk solids not fat, and may be packaged with harmless gas causing it to fluff upon ejection from the package or container. Labeling. In addition to all other required information, the label shall comply with the provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. “Freezer-made milk shake” means a pure, clean, wholesome semi-viscous drink prepared by stirring while freezing in a dispensing freezer a pasteurized mix consisting of the ingredients prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.120 Ice Milk, except that: It shall contain not less than 3-1/4 percent and not more than 6 percent milkfat. Its contents of milk solids not fat shall be not less than 10 percent. Freezer-made milk shake may only be sold or served from a dispensing freezer and may not be sold hard-frozen. Other freezer-made shakes including jumbo shake, thick shake, T.V. shake, or any coined or trade name containing the word, “shake”, shall meet the requirements of §A, of this regulation, except that the minimum percent of milk fat may be less than 3-1/4 percent. “Shakes” not meeting the requirements for “milk shakes” may not be advertised, sold, or served as milk shakes. When any freezer-made milk shake or other freezer-made shake purports to be or is represented for any special dietary use by man, it shall be sold only in a container labeled in accordance with all applicable provisions of the Code of Federal Regulations, Title 21 Food and Drugs. Description. Parevine is the food which is prepared by freezing while stirring, a pasteurized mix composed of one or more edible vegetable oils or fats, protein and carbohydrate food ingredients from other than milk or meat sources, nutritive sweeteners other than lactose, characterizing ingredients except any containing meat or milk, and any other safe and suitable ingredient which is not milk or meat or a product or derivative of milk or meat. This product may not contain any milk, milk product, meat, or meat products or any of their derivatives of any kind. Its fat content shall be not less than 10 percent, except that when bulky optional characterizing ingredients are used, the fat content may be reduced, as a result of the addition of these ingredients, but may not be less than 8 percent. Its content of food solids shall be not less than 1.3 pounds per gallon of finished product. Parevine shall be sold, held, offered for sale by any manufacturer, wholesaler, retailer, or any other seller only in factory-filled containers. Parevine may be served for consumption on the premises provided that the individual service is taken from a properly labeled factory-filled container. When parevine is served for consumption on the premises, a sign shall be conspicuously displayed on the sale premises or vehicle where it can be clearly read by customers under normal conditions of purchase, stating “PAREVINE SOLD HERE”. Letters on the sign shall be bold face capitals at least 3 inches high and in contrasting color to the background. The sign need not be displayed if each customer is provided with a menu which there is stated “PAREVINE SERVED HERE” in bold face capitals as large as those in listing most food items. Nomenclature. The name of the food is “parevine”. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. Description. “Lowfat parevine” means food which meets all of the requirements of Regulation .19, of this chapter, relating to parevine except its fat content shall be not more than 6.0 percent. The sign required by Regulation .19A(4), of this chapter, shall read “LOWFAT PAREVINE SOLD HERE”. Nomenclature. The name of the food is “lowfat parevine”. Labeling. The package label shall include, in addition to all other required information, a complete list of all ingredients in accordance with the provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4 and contain nutrition information as required by Title 21, Part 101.9. Description. “Lo-mel” means a pure, clean, wholesome semi-viscous drink prepared by stirring while freezing in a dispensing freezer a pasteurized mixture of edible fats or oils other than milkfat, milk solids not fat, water, optional sweetening ingredients as approved by the Secretary, with or without egg or egg products, with or without harmless flavoring, with or without harmless coloring, and with or without stabilizer or emulsifier as approved by the Secretary. It shall contain not more than 6 percent edible fats or oils. It shall contain not less than 10 percent milk solids not fat. It may contain any other safe and suitable ingredients approved by the Secretary. It shall contain not more than 1/2 percent by weight of stabilizer and not more than one-fifth of one percent of emulsifier. Lo-mel may only be served or sold directly from a dispensing freezer and may not be sold hard frozen. When Lo-mel is sold from a dispensing freezer a sign shall be displayed which shall read “Lo-mel Served Here”, in letters at least 3 inches high and shall include a list of all ingredients in a manner prescribed by the Secretary, provided, however, that the name of the edible fats or oils other than milk fat used must be specified. The letters of the sign are to be of sufficient size to be read by consumers under normal conditions of purchase. The list of ingredients need not be included on the sign if the list of ingredients is printed on the side of the container in which the product is served to the customer. Nomenclature. The name of the food is “lo-mel”. Labeling. When any lo-mel purports to be or is represented for any special dietary use by man, it shall be sold only in a container labeled in accordance with all applicable provisions of the Code of Federal Regulations, Title 21 Food and Drugs. Description. “Lactose reduced ice cream” means the product resulting from the treatment of ice cream, as defined in Regulation .01-1 of this chapter, by the addition of a safe and suitable enzyme, or enzymes, so that the lactose remaining is 30 percent or less than lactose in ice cream. Nomenclature. The name of the food is “lactose reduced ice cream”. Labeling. The package label shall include in addition to all other required information, a complete list of all ingredients in accordance with the provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4 and contain nutritional information as required Part 101.4 and contain nutritional information as required by Title 21, Part 101.9. Whenever the name of the food appears on the container, the words “Lactose Reduced” shall be in the same type, style, and size and in the same color and contrasting background as the words “Ice Cream”. Description. “Lactose reduced ice milk” means the product resulting from the treatment of ice milk, as defined in Regulation .02, of this chapter, by the addition of a safe and suitable enzyme, or enzymes, so that the lactose remaining is 30 percent or less than lactose in ice milk. Nomenclature. The name of the food is “lactose reduced ice milk”. Labeling. The package label shall include, in addition to all other required information, a complete list of all ingredients in accordance with provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4 and contain nutritional information as required by Title 21, Part 101.9. Whenever the name of the food appears on the container, the words “Lactose Reduced” shall be in the same type, style and size and in the same color and contrasting background as the words “Ice Milk”. Description. “Frozen pudding” means the product made from a pasteurized mix, intended to be eaten in the frozen state. The mix may be composed of milk and milk products, modified or unmodified food starch, sweetening agents, harmless natural or artificial flavoring, or both, harmless natural or artificial color, or both, or any other safe or suitable functional ingredient. The finished product shall contain less than 25 percent total food solids. The weight of the finished product shall not be less than 4.5 pounds per gallon. If not frozen promptly after pasteurization, the finished product shall be cooled to 45°F or lower and maintained under conditions to assure suitability for consumption. Nomenclature. The name of the food is “frozen pudding”. Labeling. The package label shall include, in addition to all other required information, a complete list of all ingredients in accordance with the provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4. In Regulations .21 — .34 of this chapter the following terms have the meanings indicated. Terms Defined. “Adulterated”. Frozen desserts or frozen desserts mix shall be deemed to be adulterated if: It bears or contains any poisonous or deleterious substance in a quantity which may render it injurious to health; It bears or contains any added poisonous or deleterious substances for which a safe tolerance has not been established by State or federal regulations, or in excess of the tolerance if one has been established; It consists, in whole or in part, of any substance unfit for human consumption; It has been produced, processed, prepared, packed, dispensed, or held under insanitary conditions; Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or Any substance has been added, mixed, or packed within the mix to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is. “CFR” means the Code of Federal Regulations of the United States Government. “C-I-P” means a procedure by which equipment, pipelines and other facilities are cleaned-in-place in accordance with 3-A Accepted Practices for Permanently Installed Sanitary Product-Pipelines and Cleaning Systems. “Dispensing freezer” means that type of equipment that freezes reconstituted powdered frozen dessert ingredients or frozen desserts mix into a semi-soft condition for serving to a customer. “Food service facility” means restaurants, coffee shops, cafeterias, short order cafes, luncheonettes, taverns, sandwich stands, sofa fountains, retail markets, and food operations in industries, institutions, hospitals, clubs, schools, camps, churches, catering kitchens, commissaries, or similar places in which food or drink is prepared for sale or for service on the premises or elsewhere, or any other operation where food is served or provided for the public with or without charge. “Frozen desserts” means any of the products enumerated in the law, Health-General Article, Title 21, Subtitle 8, and as provided in Regulations .01-1 — .20-3 of this chapter. “Frozen desserts distributor” means any person who offers for sale or sells prepackaged frozen desserts. “Frozen desserts mix” or “mix” means any frozen dessert in a liquid form, prepared by a frozen desserts plant and intended for freezing before consumption. “Frozen desserts plant” means any place or premise where frozen desserts or frozen dessert mixes are manufactured, pasteurized, frozen, and packaged. “Milk products” include milk, cream, and all other products listed under optional dairy ingredients as provided in Regulation .01-1 of this chapter. “Misbranded”. Frozen desserts and frozen desserts mix are misbranded when: Their containers bear or accompany any false or misleading written, printed, or graphic matter; Frozen desserts do not conform to their definitions as contained in these regulations; and Products are not labeled in accordance with Regulation .24 of this chapter. “National Sanitation Foundation” means the National Sanitation Foundation, NSF Building, P.O. Box 1468, Ann Arbor, Michigan 48106. “Pasteurization”. The terms “pasteurization”, “pasteurized”, and similar terms mean the process of heating, in approved and properly operated equipment, every particle of mix containing milk and milk products to one of the following minimum temperatures and holding at this temperature continuously for the specified time as indicated below: 155°F and holding at that temperature for at least 30 minutes; 175°F and holding at that temperature for at least 25 seconds; 180°F and holding at that temperature for at least 15 seconds; 194°F and holding at that temperature for at least 0.5 second. Nothing contained in this section shall be construed as barring any other method or process, as may be demonstrated to be equally efficient and which is approved by the Secretary. “Person” means any individual, partnership, firm, corporation, or association. “Powdered frozen dessert ingredients” means any dry mixture of pasteurized dry milk products, including whey, reduced mineral whey, whey protein concentrate, reduced lactose whey, or optional casseinates, which is intended for reconstitution, freezing, and retail sale by a food service facility. “Retail frozen desserts manufacturer” means a person who manufactures frozen desserts from commercially supplied pasteurized mix derived from raw milk supplies having acceptable United States Public Health Service (U.S.P.H.S.) ratings, for retail sale directly to the consumer on the premises where manufactured. “Sanitization” means the application of any effective method or substance to a clean surface for the destruction of pathogens, and of other organisms as far as is practicable. This treatment may not adversely affect the equipment, frozen desserts, or the health of consumers, and shall be acceptable to the Secretary. “Secretary” means the Secretary of Health or his designee. "3-A Standards" means the standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committee representing the International Association of Milk, Food and Environmental Sanitarians, the U.S. Public Health Service, and the Dairy Industry Committee, as published by the Journal of Food Protection, P.O. Box 701, Ames, Iowa 50010. “Wholesale frozen desserts manufacturer” means a person who manufactures, pasteurizes, packages, or freezes any frozen desserts mix for distribution or sale other than for retail sale directly to the consumer on the premises where manufactured. All milk products used in frozen desserts shall be derived from Grade “A” milk or milk products as defined in COMAR 10.15.06.02 or manufactured grade milk or milk products as defined in COMAR 10.15.09.02. A person may not manufacture, freeze, sell, offer or expose for sale, or have in his possession with the intent to sell any milk product, frozen dessert ingredients, frozen dessert mix which is adulterated or misbranded or which does not conform to the product definition or of any regulation made and promulgated under these regulations. Any adulterated or misbranded milk product, frozen dessert ingredients, frozen dessert, or frozen dessert mix may be detained by the Secretary and disposed of in accordance with Health-General Article, §§21-253 and 21-254, Annotated Code of Maryland. All labeling shall comply with the regulations promulgated under the Fair Packaging and Labeling Act and the Federal Food, Drug and Cosmetic Act, as contained in the Code of Federal Regulations, Title 21 Food and Drugs, and in addition shall contain: The name of the product, and shall conform with product standards of identity as provided in Regulations .01-1 — .20 of this chapter. A statement of net contents or net volume. One of the following: The name of the manufacturer and the address of his plant; The Federal Information Processing System (FIPS) Number assigned by State agency followed by the general office address; or In case of private labels, the Federal Information Processing System (FIPS) Number and the name and address of the distributor, preceded or followed by “Distributed by” or “Distributor”. The “date of pasteurization” in case of frozen dessert mixes. When frozen desserts are dispensed from factory-filled containers, each container shall bear an identity as described above so that it can be read after the lid or cover has been removed and discarded. Required labeling information shall be in letters of an acceptable size, kind, and color satisfactory to the Secretary and may not bear or accompany any false or misleading written, printed, or graphic matter. All milk and milk products used as ingredients in frozen desserts and frozen desserts mix shall be produced, processed, and pasteurized to conform with the following chemical, bacteriological, and temperature standards: A process or manipulation, other than pasteurization processing methods, and appropriate refrigeration, may not be applied to milk and milk products for the purpose of removing or deactivating microorganisms. Bacterial counts, coliform determinations, cooling temperatures, phosphatase test and other laboratory and screening tests shall conform to the procedures in the latest edition of Standard Methods for the Examination of Dairy Products of the American Public Health Association and the latest edition of the Official Method of Analysis of the Association of Official Analytical Chemists. Examinations and tests shall include any other chemical, bacteriological, or physical determinations as the Secretary deems necessary for the detection of adulteration. Sterile frozen desserts mix in hermetically sealed containers shall meet all applicable requirements. Bacterial, coliform, and cooling standards do not apply to mix in hermetically sealed containers. When samples are obtained from bulk containers of frozen desserts or frozen desserts mix, only a cleaned and sanitized dipper shall be used to obtain a sample from a portion of the bulk amount not previously contacted by a dipper. Frozen dessert mix samples for determining the wholesale frozen dessert manufacturer’s compliance with bacteriological and temperature standards shall be collected while in the possession of the wholesale frozen dessert manufacturer before final delivery. Frozen dessert mix samples for chemical and physical analysis may be taken at any time. The wholesale frozen desserts manufacturer shall be held responsible only for those samples taken from unopened containers. Samples of hard frozen desserts, in unopened factory-filled containers, may be collected any time before sale for determining the wholesale frozen dessert manufacturer's or retail frozen dessert manufacturer's compliance with chemical and physical standards. Mix once drawn from a dispensing freezer shall not be re-used. Floors — Construction. The floors of all rooms shall be kept in good repair subject to the following provisions: Rooms used for storing milk products or frozen desserts ingredients need not be provided with floor drains when the floors are sloped to drain to one or more exits; Rooms used for the hardening and storage of frozen desserts are not required to have floor drains or sloped floors; Storage rooms for storing dry ingredients, dry milk products, or packaging materials need not be provided with drains, and the floors may be constructed of tightly joined wood; and Construction of establishments which freeze and sell only at retail on the premises, shall require that the portion of the room in which the freezer is installed and the room in which containers or utensils are washed have solid impervious floors of an approved washable material; The floors of all rooms except as provided in §A(1)(a) — (c) of this regulation shall be: Constructed of concrete or other equally impervious and easily cleaned material; Smooth; Properly sloped; and Provided with trapped drains. Walls and Ceilings — Construction. Walls and ceilings of rooms in which milk products, frozen desserts ingredients, and frozen desserts are handled, processed, packaged, or stored, or in which product-contact containers, utensils, and equipment are washed, shall have a surface that is: Smooth; Washable; Light colored; and In good repair. Doors and Windows. Effective means shall be provided to prevent the access of flies and rodents. Air screens and flaps may be used where they effectively prevent the entrance of insects. Openings to the outside shall have solid doors or glazed windows which shall be closed during dusty weather. Outside doors shall be self-closing where practicable. Lighting and Ventilation. Rooms in which milk products, frozen desserts ingredients, or frozen desserts are handled, processed, stored, and packaged, or in which product-contact containers, utensils, and equipment are washed shall be well lit and well ventilated. Separate Rooms. There shall be separate rooms for the following: Pasteurizing, processing, cooling, freezing, and packaging; Freezer-storage; Cleaning of milk cans and containers; and Boiler rooms. Receiving Rooms. A plant receiving milk products or mix in bulk transport tanks shall provide a receiving room for receiving, cleaning, and sanitizing transport tanks. Unless all milk products and mix are received in bulk transport tanks, a receiving room separate from the rooms listed in §E(1) of this regulation, is required. Rooms in which milk products, frozen dessert ingredients, or frozen desserts are handled, processed, stored, or packaged, or in which product-contact containers, utensils, and equipment are washed or stored, may not open directly into any room for domestic purposes. Sanitary Piping. Sanitary piping, fittings, and connections which are exposed to milk products, frozen dessert ingredients, and frozen desserts mix, or from which liquids may drip, drain, or be drawn into the product, shall be constructed of material that is: Smooth; Impervious; Corrosion-resistant; Nontoxic; and Easily cleanable. Piping shall be kept in good repair. Pasteurized milk products, frozen dessert ingredients, and frozen desserts mix shall be conducted from one piece of equipment to another only through sanitary piping as described in Items 10p. and 11p. in the Grade “A” Pasteurized Milk Ordinance. Toilet-Sewage Disposal Facilities. A frozen desserts plant shall provide toilet facilities. Toilet rooms may not open directly into any room in which milk products, frozen dessert ingredients, or frozen desserts are processed or packaged. Toilet rooms shall: Be completely enclosed; and Have tight-fitting, self-closing doors. Dressing rooms, toilet rooms, and fixtures shall be kept in a clean condition, in good repair, and shall be well ventilated and well lit. Sewage and other liquid wastes shall be disposed of as approved by the Secretary. Water Supply. Water for frozen desserts plant purposes shall be: Obtained from a properly located, protected, and operated supply; Easily accessible; Adequate; Of a safe sanitary quality; and Approved by the Secretary. Both hot and cold water shall be available in sufficient quantity for all plant operations and facilities. Handwashing Facilities. Convenient handwashing facilities shall be provided, including: Hot and cold or warm running water; Soap; and Individual sanitary towels or other approved hand-drying devices. Handwashing facilities shall be kept in a clean condition and in good repair. Plant Cleanliness. Rooms in which milk products, frozen dessert ingredients, and frozen desserts are handled, processed, stored, or packaged or in which containers, utensils, or equipment are washed or stored, shall be kept clean, neat, and free of evidence of insects and rodents. Only properly applied pesticides, approved by the State and federal agencies for pesticide control, shall be used. Only equipment directly related to processing and packaging operations, or to handling of containers, utensils, and equipment shall be permitted in the pasteurizing, processing, cooling, packaging, and bulk milk storage rooms. Construction and Repair of Containers and Equipment. Multiuse containers and equipment with which milk products, frozen dessert ingredients, and frozen desserts come into contact shall be: Of smooth, impervious, corrosion-resistant, nontoxic material; Constructed and installed for ease of cleaning; and Kept in good repair. Single-service Containers. Single-service containers, closures, gaskets, and other articles with which milk products, frozen dessert ingredients, or frozen desserts come into contact shall: Be nontoxic; and Have been manufactured, packaged, transported, and handled in a sanitary manner. Articles intended for single-service use may not be reused. Equipment pertaining to materials, design, and finish shall comply with applicable 3-A Sanitary Standards. Cleaning and Sanitizing of Containers and Equipment. The product-contact surface of all multiuse containers, utensils, and equipment used in the transportation, processing, handling, freezing, packaging, and storage of milk products, frozen dessert ingredients and frozen desserts mix shall be effectively cleaned and sanitized before each use. Storage of Cleaned Multiuse Containers and Equipment. After cleaning, multiuse milk products, frozen dessert ingredients, and frozen dessert containers, utensils, and equipment shall be: Transported and stored to assure complete drainage; and Protected from contamination before use. Storage of Single-Service Containers, Utensils and Materials. Single-service parchment papers, containers, gaskets, and other single-service articles for use in contact with milk products, frozen dessert ingredients, or frozen desserts shall be: Purchased and stored in sanitary wrappings or cartons; Kept in a clean dry place until used; and Handled in a sanitary manner. Protection from Contamination. Frozen desserts plant operations, equipment, and facilities shall be located and conducted to prevent any contamination of: Milk products; Frozen dessert ingredients; Frozen desserts; Equipment; Containers; and Utensils. Unless the equipment has first been properly washed and subjected to a satisfactory bactericidal treatment, pasteurized mix or frozen desserts may not be permitted to come in contact with equipment or containers with which unpasteurized mix, frozen desserts, milk, or milk products have been in contact. In a frozen desserts plant, processing and handling shall be performed to preclude the contamination of the products. Pasteurization. Frozen desserts shall be made from pasteurized mixes. After formulation of the entire mix except for flavoring, ingredients shall be pasteurized as provided in Regulation .21B(13) of this chapter. The design and operation of all pasteurization equipment and all appurtenances to it shall comply with the applicable specifications and operational procedures as outlined in Appendices H and I of the Grade “A” Pasteurized Milk Ordinance. Cooling of Milk Products and Frozen Desserts Mix. Raw milk products shall be maintained at 45°F or less until processed. Pasteurized milk products and frozen desserts mix shall be cooled immediately, in approved equipment, to a temperature of 45°F or less. Pasteurized milk and frozen desserts mix shall be stored at a temperature of 45°F or less and maintained at that temperature until further processed. A room or tank in which products or frozen desserts mix are stored shall be equipped with an accurate thermometer. A mix which is not frozen at the plant at which it is pasteurized shall be: Transported to the place of manufacturing or freezing in sealed containers; Handled in a sanitary manner; and Stored at a temperature of 45°F or less until frozen. Except for sampling, dipping from containers of pasteurized mix is prohibited. Container Packaging, Closure, Sealing, and Storage. Closing or sealing of frozen desserts containers shall be done in a sanitary manner. The closing or sealing of individual containers of frozen desserts shall be done by methods which preclude product contamination. Frozen desserts shall be stored in a sanitary manner. Personnel Cleanliness. Hand Washing. Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination. An employee may not resume work after visiting the toilet room without thoroughly washing the employee’s hands. Garments and Hair Coverings. An individual engaged in processing, pasteurization, handling, storage, transportation, or packaging of milk products, frozen dessert ingredients or frozen desserts, containers, utensils, or equipment shall wear clean outer garments and a head covering. An employee with long hair shall wear hair restraints. The use of tobacco by any person while engaged in the processing of milk products, frozen desserts ingredients, or frozen desserts is prohibited. Packaging, Overflow, and Spillage. Packaging. The filling of frozen desserts containers shall be done only by approved mechanical equipment or by methods which preclude contamination. Frozen desserts shall be packaged in containers which protect the contents from contamination. Frozen desserts or frozen desserts mix: May be transported in sealed containers in a sanitary manner from one plant to another for further processing or packaging; and Shall be stored in a sanitary manner. Milk products, frozen desserts, or their ingredients which have been spilled, overflowed, or leaked shall be discarded and may not be sold for human consumption. Vehicles. Vehicles used for transportation of frozen desserts mix shall be constructed and operated so that the frozen desserts mix is: Maintained at 45°F or less; and Protected from; Sun; Freezing; and Contamination. Vehicles used for transportation of frozen desserts mix shall be kept clean. Substances capable of contaminating mix or frozen desserts or their ingredients may not be transported with frozen desserts mixes in a manner which permits contamination. Vehicles transporting frozen desserts or mix to wholesale or retail outlets shall have the name and address of the distributor prominently displayed on them. Transferring and Dispensing Frozen Desserts. Except for in a sanitary room or enclosure under approved conditions a person may not: Transfer frozen desserts from one container to another; or Package frozen desserts: On the street; or In any open vehicle. The direct sale of frozen desserts in packages, cones, or servings to the consumer may take place at roadside stands or concessions where the sanitary conditions are approved by the Secretary. Surroundings. Frozen desserts plant surroundings shall be kept clean, neat, and free from conditions which might attract or harbor flies or other insects and rodents, or which otherwise constitute a nuisance. Roads, driveways, yards, and parking areas adjacent to the plant shall be: Paved or otherwise treated to prevent dust; and Smooth and well drained to prevent accumulation of stagnant liquid. Upon application for a frozen desserts license, every plant shall be inspected to determine compliance with these regulations. Following the issuance of a license, every plant shall be inspected at least once every 3 months. If violations are found, notice shall be given as provided in the Frozen Desserts Law, Health-General Article, §21-813, Annotated Code of Maryland. Every licensee shall permit access to all parts of the establishment, and shall furnish the Secretary upon his request, for official use only: A true statement of actual quantities of milk products, mix, or frozen desserts used or produced; Sources of milk products, ingredients, or mix; Inspection and tests; Past records; and Pertinent information as to persons employed. Before engaging in the business of manufacturing any frozen desserts mix or frozen dessert regardless of the name under which the product is sold, every person shall first obtain a license from the Maryland Department of Health, Office of Environmental Programs, Division of Milk Control. Only a person who complies with the requirements of this regulation is entitled to receive and retain a license. Suspension — Revocation of License. A license may be suspended or revoked by the Secretary as follows: Upon the violation by the holder of any of the provisions of this law and regulations; Immediately when an imminent health hazard is found to exist; or For interference with the Secretary in the performance of his duties. Frequency of Sampling. Pursuant to Health-General Article, §21-804, Annotated Code of Maryland, during any consecutive 6-month period at least two samples of frozen desserts mix and frozen desserts shall be taken from each wholesale frozen dessert manufacturer. Samples of milk and milk products used as ingredients in frozen desserts shall be taken periodically. Enforcement. In accordance with Health-General Article, §21-813, Annotated Code of Maryland, the licensee shall be notified of violations. Whenever two of the last four consecutive samples of different batches of the same flavor of the same product, taken on separate days, exceed bacteria count, coliform determinations, or temperature standards as provided in Regulation .25 of this chapter, the licensee shall be notified of the results by mail and ordered to appear before the Secretary to review possible causes. At the same time, the licensee shall be warned that should the results of the next sample, collected within 14 days of the meeting, violate the standards by three of the last five bacteria counts, coliform determinations, or cooling temperatures, his license may be suspended. The suspension shall remain in effect so long as two of the last four consecutive samples exceed the limit of the standards. Failure to appear, without due notification, shall be cause for immediate suspension. Upon repeated violations, the Secretary may revoke a license following reasonable notice to the licensee and an opportunity for a hearing. This section is not intended to preclude the institution of court action. The Secretary may forego suspension of the license provided the product or products in violation are not sold, offered for sale, or given away. Whenever a phosphatase test is positive the cause shall be determined. When the cause is improper pasteurization, it shall be corrected and any product involved may not be sold, offered for sale, or given away. Reinstatement of License. In accordance with Health-General Article, §21-814, Annotated Code of Maryland, any license holder whose license has been suspended may make written application at any time for the reinstatement of his license. When the license suspension has been due to a violation of any of the bacteria, coliform, or cooling temperature standards, the Secretary, within 1 week after the receipt of a written application for reinstatement of license, shall issue a temporary license by letter, after determining by an inspection of the facilities and operation methods that the conditions responsible for the violation have been corrected. Samples shall then be taken at the rate of not more than two per week on separate days within a 3-week period, and the Secretary shall reinstate the license upon compliance with the appropriate standard as determined in accordance with §B of this regulation. Whenever the license suspension has been due to a violation of a requirement other than the bacteriological, coliform, or cooling temperature standards, the application shall contain a written statement of the effect that the violation has been corrected. Within 1 week of the receipt of the application, the Secretary shall make an inspection of the applicant's establishment and as many additional inspections thereafter as are deemed necessary to determine that the applicant's establishment is complying with the requirements. When the findings justify, the license shall be reinstated. Only frozen desserts and frozen desserts mix manufactured by a licensed wholesale frozen desserts manufacturer or retail frozen desserts manufacturer shall be sold to the final consumer, or to restaurants, soda fountains, grocery stores, or similar establishments. Properly prepared plans for all frozen desserts plants regulated under these regulations, which are hereafter constructed, reconstructed, or extensively altered, shall be submitted to the Secretary for written approval before work is begun. A person affected with any disease in a communicable form, or who is a carrier of a communicable disease, may not work at any frozen desserts plant in any capacity which brings him in contact with the production, handling, storage, or transportation of milk, milk products, other frozen dessert ingredients, frozen desserts, or frozen desserts mix containers, equipment, and utensils. A plant operator may not employ in this capacity any infected person, or any person suspected of having any disease in a communicable form, or of being a carrier of a communicable disease. Any permit holder, in whose frozen desserts plant any communicable disease occurs, or who suspects that any employee has contracted any disease in any form, or has become a carrier of a disease, shall notify the Secretary immediately. When reasonable cause exists to suspect the possibility of transmission of infection from any person concerned with the handling of milk, milk products, other than frozen dessert ingredients, frozen desserts, or frozen desserts mix, the Secretary is authorized to require any or all of the following measures: The immediate exclusion of that person from product handling; The immediate exclusion of the products concerned from distribution and use; and Adequate medical and bacteriological examination of the person, of his associates, and of his and their body discharges. When a dispensing freezer is used in a food service facility, it shall be exempt from the provisions of Regulations .22 — .24, .26 — .33, and .35 of this chapter. The operation and maintenance of this equipment shall comply with the provisions of COMAR 10.15.03. Retail frozen dessert manufacturers shall be exempt from the provisions of Regulations .22—.24, .26—.27 and .31—.33 under this chapter. The sanitation requirements and operation and maintenance of equipment of retail frozen dessert manufacturers shall comply with the provisions of COMAR 10.15.03. Retail frozen dessert manufacturers shall manufacture frozen desserts from Grade “A” milk or milk products as defined in COMAR 10.15.06.02 or manufactured grade milk or milk products as defined in COMAR 10.15.09.02. Health-General Article, §21-804, Annotated Code of Maryland Effective date: November 15, 1973 Regulations .25A, .26U, and .27A amended effective August 25, 1978 (5:17 Md. R. 1330) Chapter revised effective June 12, 1981 (8:12 Md. R. 1062) Regulations .02C, .14, .21B, .25G, H, I, .29A, and .30 amended effective January 12, 1987 (14:1 Md. R. 31) Regulations .10-1, .20-1, .20-2, and .20-3 adopted effective January 12, 1987 (14:1 Md. R. 31) Regulation .21B amended effective January 2, 1994 (20:26 Md. R. 2027) Regulation .22 amended as an emergency provision effective June 27, 2012 (39:15 Md. R. 962); amended permanently effective October 1, 2012 (39:19 Md. R. 1236) Regulation .25A amended effective January 2, 1994 (20:26 Md. R. 2027) Regulation .35 repealed and new regulation .35 adopted effective January 12, 1987 (14:1 Md. R. 31) Regulation .35 amended as an emergency provision effective June 27, 2012 (39:15 Md. R. 962); amended permanently effective October 1, 2012 (39:19 Md. R. 1236) Chapter revised effective February 27, 2017 (44:4 Md. R. 254)