Authority: Health-General Article, §§18-102, 21-101, 21-102, 21-211, and 21-234, and 21-304; Agriculture Article, §4-311; Annotated Code of Maryland

10.15.03.00

Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE

Subtitle 15 FOOD

Chapter 03 Food Service Facilities

.01 Scope.

This chapter:

A. Governs food service facilities in Maryland;

B. Along with COMAR 10.15.04, 15.04.01, and 15.11.11, establishes the standards for the control of Salmonella Enteritidis in shell eggs and egg-producing chickens as part of a program jointly administered by the Maryland Department of Health and Mental Hygiene and the Maryland Department of Agriculture; and

C. Is not intended to govern the food service operations in a child care center as defined in Family Law Article, §5-570, Annotated Code of Maryland, or a family day care home as defined in Family Law Article, §5-501, Annotated Code of Maryland, unless the food service operation is conducted in conjunction with another institution that is governed by this chapter.

.02 Definitions.

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

B. Terms Defined.

(1) "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.

(2) Adulterated.

(a) "Adulterated" has the meaning stated in Health-General Article, §§21-207, 21-208, and 21-209, Annotated Code of Maryland.

(b) "Adulterated" includes food that:

(i) Contains any poisonous or deleterious substance;

(ii) Is diseased, contaminated, filthy, putrid, or decomposed; or

(iii) Is otherwise unfit as food for human beings.

(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; and

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

(4) "Approving authority" means:

(a) Within the State, the Secretary of Health and Mental Hygiene or the Secretary's designee; or

(b) Outside the State, the agency designated in the laws of another state or country to license or permit a food establishment.

(5) "aw" means water activity, which is:

(a) The ratio of the water vapor pressure of a food to the vapor pressure of pure water at the same temperature; and

(b) An index of the available, free moisture in food.

(6) Bake Sale.

(a) "Bake sale" means a place where only non-potentially hazardous bakery goods, including breads and pastries, are sold in conjunction with a fundraising event.

(b) "Bake sale" does not include a place:

(i) Where a person sells baked goods for individual profit;

(ii) From which food is commercially distributed; or

(iii) Where a potentially hazardous baked good is sold or distributed.

(7) "Barrier" means a physical, biological, or chemical factor that retards or prevents the growth of microorganisms that are infectious or toxigenic.

(8) "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.

(9) "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.

(10) "Caterer" means a food service facility that:

(a) Offers catering services; or

(b) Identifies itself as a caterer.

(11) "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:

(a) Specific public event; or

(b) Business or social function or affair.

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

(a) Application of heat, pressure, or other energy or matter that renders a 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 may 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.

(13) Comminuted.

(a) "Comminuted" means reduced in size by methods including:

(i) Chopping;

(ii) Flaking;

(iii) Grinding; or

(iv) Mincing.

(b) "Comminuted" includes fish, meat, or a mixture of products that are reduced in size and restructured or reformulated, such as:

(i) Gefilte fish;

(ii) Formed roast beef;

(iii) The meat used in gyros;

(iv) Ground beef; and

(v) Sausage.

(14) "Condiment" means a food or seasoning used to enhance the flavor of another food, including:

(a) Mustard;

(b) Ketchup;

(d) Relish;

(e) Salt;

(f) Pepper;

(g) Sugar; or

(h) Chutney.

(15) "Consumer advisory" means a written notification to consumers that:

(a) 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:

(i) Raw;

(ii) Undercooked; or

(iii) Not otherwise processed to eliminate pathogens; and

(b) 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.

(16) Continental Breakfast.

(a) "Continental breakfast" means a meal that does not require major food preparation as specified in Regulation

.28E(2) of this chapter.

(b) "Continental breakfast" includes foods such as:

(i) Coffee and tea;

(ii) Juice;

(iii) Cereal;

(iv) Milk and cream;

(v) Whole fresh fruit;

(vi) Pastries;

(vii) Bread;

(viii) Donuts;

(ix) Butter and margarine; and

(x) Jams and jellies.

(i) Eggs cooked outside of the shell;

(ii) Meat; and

(iii) Fruit salad prepared on premises.

(17) "Corrosion resistant" means the property that allows a material to maintain sanitary surface characteristics under the influence of prolonged contact with:

(a) Food;

(b) Cleaning compounds;

(d) Other conditions of the environment.

(18) "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.

(19) 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) Obtaining food from an approved source;

(ii) Protecting food from adulteration, spoilage, and contamination;

(iii) Restricting food workers with infection or diarrhea in accordance with COMAR 10.06.01;

(iv) 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;

(v) Cooling and refrigerating potentially hazardous foods in accordance with the requirements of this chapter;

(vi) Holding potentially hazardous foods at the hot and cold temperatures specified in this chapter;

(vii) Cooking and reheating potentially hazardous foods in accordance with the requirements of this chapter;

(viii) Providing potable hot and cold running water; and

(ix) Discharging sewage from the facility in accordance with all applicable State and local codes.

(20) "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.

(21) "Department" means the Department of Health and Mental Hygiene or the Department's designee.

(22) "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.

(23) "Easily cleanable" means the property of a surface that allows the surface to:

(a) Be readily accessible; and

(b) Have soil and residue removed by routine cleaning methods.

(24) "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.

(25) "Egg case" means a container that:

(a) Is not a carton;

(b) Holds either loose shell eggs or cartons of eggs; and

(26) "Employee" means:

(a) The licensee;

(b) An individual having supervisory or management duties;

(d) A volunteer;

(e) An individual performing work under contractual agreement; or

(f) Any other individual working in a food service facility.

(27) Equipment.

(a) "Equipment" means an item, other than a utensil, that is used in the operation of a food establishment for:

(i) Storage;

(ii) Preparation;

(iii) Display;

(iv) Washing; or

(v) Transportation.

(b) "Equipment" includes a:

(i) Stove;

(ii) Oven;

(iii) Hood;

(iv) Slicer;

(v) Grinder;

(vi) Mixer;

(vii) Scale;

(viii) Meat block;

(ix) Table;

(x) Food shelf;

(xi) Refrigerator;

(xii) Freezer;

(xiii) Sink;

(xiv) Ice maker; or

(xv) Another item used in the operation of a food service facility.

(i) Forklift truck; or

(ii) Dolly.

(28) "Excluded organization" means a:

(a) 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 14 consecutive days; or

(b) Volunteer fire company that does not serve food to the public more often than 4 days per week, except that once a year a volunteer fire company may serve food to the public for up to 30 consecutive days.

(29) 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.

(30) Farmer's Market.

(a) "Farmer's market" means a place where a person offers or sells one or more of the following food products to the public:

(i) Raw agricultural products such as fruits, vegetables, and grains supplied directly from a farm;

(ii) Products processed in a private home kitchen located on a farm according to Regulation .27 of this chapter;

(iii) 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

(iv) Eggs sold only on a farm that is in compliance with Regulation .05A(8) of this chapter.

(b) "Farmer's market" does not include a food service facility.

(31) "Food" means:

(a) A substance that is used as:

(i) Food or drink for human beings; or

(ii) A component of food or drink for human beings; or

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

(32) "Food-contact surface" means a surface:

(a) Of equipment and utensils with which food normally comes in contact; or

(b) From which food may drain, drip, or splash onto a:

(i) Food; or

(ii) Surface normally in contact with food.

(33) "Food processing plant" has the meaning stated in COMAR 10.15.04.02B.

(34) Food Service Facility.

(a) "Food service facility" means:

(i) A place where food or drink is prepared for sale or service on the premises or elsewhere; or

(ii) An operation where food is served to or provided for the public with or without charge.

(b) "Food service facility" includes:

(i) A restaurant, coffee shop, cafeteria, short order cafe, luncheonette, tavern, sandwich stand, soda fountain, retail market, or retail bakery outlet;

(ii) 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

(iii) An excluded organization either with or without a license that serves potentially hazardous foods.

(i) Facility that offers only prepackaged foods that are not potentially hazardous as specified in §B(55)(c) of this regulation;

(ii) 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;

(iii) Food preparation or serving area where only non-potentially hazardous food is prepared or served only by an excluded organization;

(iv) A lodging or rooming house that serves only a continental breakfast; or

(v) A farmer's market offering or selling to the public raw fruit, vegetables, and other food products as specified in Regulation .27 of this chapter or eggs sold only on a farm that is in compliance with Regulation .05A(8) of this chapter.

(35) Game Animal.

(a) "Game animal" means an animal:

(i) That is food for human beings; and

(ii) That is not classified as cattle, sheep, swine, goat, mule, or other equine.

(b) "Game animal" includes:

(i) Reindeer;

(ii) Elk;

(iii) Deer;

(iv) Antelope;

(v) Water buffalo;

(vi) Bison;

(vii) Rabbit;

(viii) Squirrel;

(ix) Opossum;

(x) Raccoon;

(xi) Nutria;

(xii) Muskrat;

(xiii) Bear; and

(xiv) Nonaquatic reptiles such as land snakes.

(i) Ostrich;

(ii) Emu; and

(iii) Rhea.

(36) "Hazard" means a biological, chemical, or physical property that may be detrimental to public health.

(37) "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.

(38) Health Care Facility.

(a) "Health care facility" means:

(i) A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland;

(ii) A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland;

(iii) An ambulatory surgical facility or center as defined in Health-General Article, §19-114, Annotated Code of Maryland;

(iv) 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;

(v) A home health agency, as defined in Health-General Article, §19-401, Annotated Code of Maryland;

(vi) A hospice facility, as defined in Health-General Article, §19-901, Annotated Code of Maryland; or

(vii) Another health institution, service, or program for which Health-General Article, §19-114(d)(1)(viii), Annotated Code of Maryland, requires a certificate of need.

(b) "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.

(39) "Hermetically sealed container" means a container that:

(a) Is secure against the entry of microorganisms; and

(b) Maintains the commercial sterility of the contents after processing.

(40) "Juice" means:

(a) The aqueous liquid expressed or extracted from one or more fruits or vegetables;

(b) Purees of the edible portion of one or more fruits or vegetables; or

(41) "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.

(42) "Loose eggs" means shell eggs not contained in a carton.

(43) "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.

(44) Major Food Allergen.

(a) "Major food allergen" means:

(i) Milk;

(ii) Egg;

(iii) Fish such as bass, flounder, or cod;

(iv) Crustacea such as crab, lobster, or shrimp;

(v) Tree nuts such as almonds, pecans, or walnuts;

(vi) Wheat;

(vii) Peanuts;

(viii) Soybeans; and

(ix) A food ingredient that contains protein derived from milk, egg, fish, tree nuts, wheat, peanuts, or soybeans.

(b) "Major food allergen" does not include:

(i) 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

(ii) 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).

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

(46) Mobile Food Service Facility.

(a) "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:

(i) Change location for sales;

(ii) Obtain food and other supplies;

(iii) Fill potable water supply holding tanks;

(iv) Empty wastewater holding tanks; or

(v) Provide for the cleaning and sanitization of equipment and utensils.

(b) "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.

(47) "Non-potentially hazardous food" means food named or described in §B(55)(c) of this regulation.

(48) "On-farm food service facility" means a temporary food service facility that:

(a) Is located on a farm;

(b) Serves only those foods approved by the Department, based on a:

(i) Review of the facility, equipment, and processing hazards; and

(ii) Determination that these foods can be prepared safely and in a manner that conforms to applicable laws and regulations; and

(49) "Package" means a bottle, can, carton, bag, or wrapped container.

(50) "Packer" means a person who places shell eggs in the original case, carton, or container that is used to hold eggs for:

(a) Distribution; or

(b) Sale to a consumer.

(51) "Person" has the meaning stated in Health-General Article, §§1-101 and 21-101, including:

(a) An operator of a facility that is owned by the State or local unit of government; or

(b) A State or local unit of government if the State or local unit of government is the operator of the facility.

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

(a) The licensee; or

(b) Another person responsible for the operation of a food service facility.

(53) "pH" means the symbol for the negative logarithm of the hydrogen ion concentration in gram equivalents per liter of solution where:

(a) pH values from 0 to 7 indicate acidity;

(b) pH values from 7 to14 indicate alkalinity; and

(54) "Portable" means that equipment:

(a) Can be easily moved because the equipment is:

(i) Small in size and weighs 80 pounds or less;

(ii) Mounted on casters, gliders, or rollers; or

(iii) Provided with a mechanical means of safely tilting for cleaning; and

(b) Has one of the following:

(i) No utility connection;

(ii) A utility connection that disconnects quickly; or

(iii) A flexible utility connection line long enough to permit the equipment to be moved for thorough cleaning.

(55) 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" includes:

(i) A food of animal origin that is raw or heat-treated;

(ii) A food of plant origin that is heat-treated;

(iii) Raw seed sprouts;

(iv) Cut melons; and

(v) Garlic and oil mixtures that support growth as specified in §B(55)(a)(i) and (ii) of this regulation.

(i) Hard-boiled shell egg that has been air-cooled with the shell intact;

(ii) Food with an aw value of 0.85 or less;

(iii) Food with a pH level of 4.6 or below when measured at 75°F;

(iv) Commercially sterile food in a hermetically sealed container; or

(v) 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.

(56) "Poultry" means a:

(a) Domesticated bird whether live or dead including a:

(i) Chicken;

(ii) Turkey;

(iii) Duck;

(iv) Goose;

(v) Guinea;

(vi) Ratite; or

(vii) Squab; and

(b) Migratory waterfowl or game bird whether live or dead, including a:

(i) Pheasant;

(ii) Partridge;

(iii) Quail; or

(iv) Grouse.

(57) "Premises" means the physical food service facility and the contiguous land or property under the control of the operator or the licensee.

(58) "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.

(59) "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.

(60) Public Event.

(a) "Public event" means an event that is:

(i) Attended by individuals from the general public whether or not a fee is charged; or

(ii) Advertised with fliers, banners, newspaper articles, radio or television announcements, or on an Internet website as being open to the public.

(b) "Public event" does not include a:

(i) Private party;

(ii) An event restricted to organization members; or

(iii) Another event that restricts the general public from attending.

(61) Ready-to-Eat Food.

(a) "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.

(b) "Ready-to-eat food" includes:

(i) 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;

(ii) Raw fruits and vegetables that are washed and cut;

(iii) Whole, raw fruits and vegetables that are presented for consumption without need for further washing, such as at a buffet; and

(iv) A food presented for consumption for which further washing or cooking is not required and from which rinds, peels, husks, or shells are removed.

(62) "Reconstituted" means water or other liquid has been restored to a food that was previously dehydrated.

(63) Reduced Oxygen Packaged.

(a) "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:

(i) Mechanical evacuation of oxygen;

(ii) Displacement of oxygen with one or more gases; or

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

(b) "Reduced oxygen packaged" includes food that is:

(i) Vacuum packaged;

(ii) Modified atmosphere packaged; and

(iii) Controlled atmosphere packaged.

(64) "Refrigerated food" means a food that:

(a) Is not shelf stable;

(b) Must be refrigerated to:

(i) Retard the growth of spoilage or pathogenic microorganisms; and

(ii) Prevent the production of microbial toxins; or

(65) "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.

(66) "Registration number" means the number that the Maryland Department of Agriculture assigns a packer.

(67) "Retail food manufacturing" means the manufacturing of food in a food service facility for wholesale distribution.

(68) "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.

(69) "Secretary" means the Secretary of Health and Mental Hygiene or the Secretary's designee.

(70) "Semi-permanent food service facility" means a facility that:

(a) Is built at a location other than where it operates;

(b) Is transported as a complete unit that does not require a building permit to install on the location at which it operates;

(d) When serving cooked food, serves only foods cooked for immediate service; and

(e) Is not a mobile food service facility as specified in §B(46) of this regulation.

(71) "Service animal" means an animal such as a dog that is individually trained to provide assistance to an individual with a disability.

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

(73) "Shellfish" means all species of:

(a) Oysters, clams, or mussels, whether:

(i) Shucked or in the shell;

(ii) Raw, including post-harvest processed;

(iii) Frozen or unfrozen; and

(iv) Whole or in part; and

(b) Scallops in any form, except when the final product is the adductor muscle only.

(74) Single Service Article.

(a) "Single service article" means an article designed, fabricated, and intended for one-time consumer use.

(b) "Single service article" includes a:

(i) Utensil;

(ii) Cup;

(iii) Plate;

(iv) Stirrer;

(v) Napkin;

(vi) Straw;

(vii) Toothpick;

(viii) Food container;

(ix) Place mat;

(x) Napkin;

(xi) Food package; or

(xii) Similar item.

(75) Single Use Article.

(a) "Single use article" means an article intended by the manufacturer for one-time use by the preparer of the food.

(b) "Single use article" includes a:

(i) Bulk food container;

(ii) Utensil;

(iii) Formed aluminum pie pan;

(iv) Jar;

(v) Plastic bucket; or

(vi) Similar item.

(76) Special Food Service Facility.

(a) "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:

(i) Design and operation of the facility;

(ii) Food preparation or service methods; or

(iii) Limited length of time that the facility operates in association with special events.

(b) "Special food service facility" includes:

(i) A bed and breakfast that serves hot meals;

(ii) A mobile unit;

(iii) A temporary food service facility;

(iv) A semi-permanent food service facility; or

(v) An on-farm food service facility.

(77) Tableware.

(a) "Tableware" means multi-use eating, drinking, and serving utensils.

(b) "Tableware" includes:

(i) Knives;

(ii) Forks;

(iii) Spoons;

(iv) Bowls;

(v) Cups;

(vi) Serving dishes;

(vii) Tumblers; and

(viii) Plates.

(78) "Temporary food service facility" means a food service facility that operates:

(a) In one of the following ways:

(i) Except for a volunteer fire company, at a fixed location for not more than 14 consecutive days; or

(ii) For up to 30 consecutive days if the temporary food service facility is a volunteer fire company; and

(b) In conjunction with a:

(i) Fair;

(ii) Carnival;

(iii) Public exhibition;

(iv) Construction project;

(v) Recreational facility; or

(vi) Similar gathering.

(79) "Time-only" means using time instead of time in conjunction with temperature as the sole means of food protection for a potentially hazardous food.

(80) "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.

(81) "Utensil" means tableware or a food-contact implement used in the storage, preparation, dispensing, or serving of food.

(82) "Vending machine" means a self-service device that dispenses either packaged or unpackaged food.

(83) "Warewashing" means the cleaning and sanitizing of food-contact surfaces of equipment or utensils.

(84) Whole Muscle, Intact Beefsteak.

(a) "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.

(b) "Whole-muscle, intact beefsteak" does not include meat that has been:

(i) Injected;

(ii) Mechanically tenderized;

(iii) Reconstructed; or

(iv) Scored.

.03 Incorporation by Reference.

A. In this chapter, the following documents are incorporated by reference.

B. Documents Incorporated.

(1) 21 CFR, as amended;

(2) 9 CFR, as amended; and

(3) 21 U.S.C. §343, as amended.

.04 Food Supplies and Sources: General.

The person-in-charge shall ensure that:

A. Food served to the public is:

(1) Wholesome and free from contamination;

(2) Not adulterated;

(3) Safe for human consumption;

(4) Obtained from an approved source; and

(5) If in packaged form, labeled in accordance with:

(a) COMAR 10.15.01;

(b) COMAR 10.15.02;

(d) This chapter;

B. Eggs and egg products comply with Regulation .05 of this chapter;

C. Milk and milk products are not sold or served unless they are produced, processed, stored, transported, and distributed in accordance with COMAR 10.15.06, including:

(1) Fluid milk;

(2) Other fluid dairy products; and

(3) Manufactured milk products;

D. Reconstituted dry milk or dry milk products are used only for:

(1) Instant desserts;

(2) Whipped products; and

(3) Cooking and baking purposes;

E. Frozen desserts including ice cream, soft frozen desserts, ice milk, sherbets, ices, gelato, and frozen dessert mix are manufactured and sold in accordance with COMAR 10.15.05;

F. Shellfish:

(1) Are obtained from an approved source;

(2) When received through interstate commerce, are from a firm listed in the "Interstate Certified Shellfish Shippers List";

(3) Are processed, handled, packed, labeled, and identified in accordance with COMAR 10.15.07;

(4) Containers are identified with a tag or label as set forth in COMAR 10.15.07; and

(5) Tags are maintained on the premises for 90 days after a container of unshucked shellfish is emptied to identify readily the source of the shellfish;

G. Crab meat is processed, handled, and packed in accordance with COMAR 10.15.02;

H. Seafood is processed, handled, and packed in accordance with COMAR 10.15.10;

I. Meat and poultry have been inspected for wholesomeness by the approving authority; and

J. Ice is:

(1) Made:

(a) From a potable water supply:

(b) In an ice-making machine that:

(i) Meets the standards in Regulation .15 of this chapter; and

(ii) Is located, installed, operated, and maintained to prevent contamination;

(2) If not manufactured on site, obtained from an approved source;

(3) Handled, transported, and stored in a manner that precludes contamination; and

(4) Not reused.

.05 Eggs and Egg Products.

A. The person-in-charge shall ensure that:

(1) Only clean, whole Grade A or higher grade eggs with shell intact and without cracks, or pasteurized eggs or egg products, are used;

(2) An invoice or other equivalent record is obtained from the supplier for each delivery of shell eggs;

(3) The invoice or equivalent record required in §A(2) of this regulation contains the following information written in English:

(a) Name and address of the seller and buyer;

(b) Date of delivery;

(d) Quantity of eggs sold in number by grade and size;

(4) When loose eggs are distributed, offered for sale, or sold directly to a consumer in Maryland:

(a) A daily record is maintained that shows the lot designation of the shell eggs for each packer;

(b) A placard is displayed that:

(i) Is legible and printed in block letters not less than 3/8 inch in height;

(ii) Is a minimum size of 4-1/4 inches by 6 inches;

(iii) Plainly and conspicuously displays the eggs' grade term, size (weight), and lot designation; and

(iv) Is placed on or near the eggs; and

(5) All egg invoices, daily records, or other equivalent records are kept on file for a minimum of 90 days;

(6) Upon request, the approving authority is granted access to copy and verify, at any reasonable time, records relating to the sale and purchase of shell eggs;

(7) Except as provided in Regulation .10 of this chapter, only pasteurized eggs and egg products are used when serving eggs or foods prepared with eggs that have not been heated adequately to kill Salmonella Enteritidis;

(8) All shell eggs accepted for delivery, used, or provided to the consumer are:

(a) Produced by flocks that are certified to be in compliance with COMAR 15.11.11;

(b) Supplied by a registered packer as provided in COMAR 15.04.01; and

(c) Pasteurized or otherwise heat-treated to kill Salmonella Enteriditis if Salmonella Enteriditis is isolated from a flock in Maryland as determined by testing procedures contained in COMAR 15.11.11;

(9) All egg cartons of shell eggs accepted for delivery, used, or provided to the consumer are labeled on the principal display or information panel with:

(a) Legible stamping in permanent ink;

(b) The following information at a minimum type size of 1/16 of an inch:

(i) The packer's or distributor's name and address;

(ii) The packer's registration number;

(iii) The lot designation of the eggs; and

(iv) A safe handling statement with the words "safe handling instructions" in bold capital letters and the statement "To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly." set off in a box by hairlines;

(i) The identity of the product as eggs; and

(ii) The word "grade" and the grade term (AA or A) and size (weight) of the eggs; and

(d) The net quantity of eggs in weight or numerical count in at least the minimum type size permitted based on the space available for labeling as set forth in §B of this regulation, with the minimum type size measurement determined by:

(i) The height of type of printing by measuring the height of the lower case letter "o" or its equivalent when mixed upper and lower case letters are used; or

(ii) The height of the upper case letters when only upper case letters are used;

(10) If the safe handling statement does not appear on the principal display panel or the front information panel, a separate statement that eggs be kept refrigerated is printed on either the principal display panel or the front of the information panel;

(11) The same information in at least the same minimum type size that is required on an egg carton is printed on the top of an egg case or any side of an egg case; and

(12) The grade term and size (weight) on an egg carton is not abbreviated.

B. Table 1.

Minimum type size Area of Principal Display Panel 1/16 inch 5 square inches or less

1/8 inch More than 5 square inches but not more than 25 square inches 3/16 inch More than 25 square inches but not more than 100 square inches 1/4 inch More than 100 square inches but not more than 400 square inches 1/2 inch Over 400 square inches

.06 Food Protection During Storage, Service, and Transport.

The person-in-charge shall ensure that:

A. At all times:

(1) Food is:

(a) Not adulterated; and

(b) Protected from contamination during storage, preparation, display, service, and transportation;

(2) The internal temperature of a food is maintained according to the requirements of this chapter to preclude the growth of pathogenic bacteria and other microorganisms that could cause spoilage;

(3) Except during necessary periods of preparation and service, a potentially hazardous food is:

(a) Refrigerated as set forth in §B(8) of this regulation; or

(b) Held hot as set forth in §C(2) of this regulation;

B. When storing and holding food:

(1) Facilities used for hot or cold potentially hazardous food are provided a temperature-measuring device that is:

(a) Graduated and accurate to plus or minus 2°F;

(b) Calibrated annually or more frequently;

(i) Coldest area of equipment where hot foods are stored; and

(ii) Warmest area of equipment where cold foods are stored; and

(d) Easily readable;

(2) Except for metal beverage containers and cased food packaged in cans, glass, or other waterproof containers stored as provided in §B(3) of this regulation, containers of food are stored:

(a) Off the floor;

(b) 18 inches above the floor or higher if food is exposed;

(d) In a manner that will protect from splash and other contamination;

(3) When metal beverage containers and cased food in cans, glass, or other waterproof containers are stored on the floor:

(a) The floor is maintained in a clean and sanitary condition;

(b) The storage:

(i) Is temporary such as for floor displays;

(ii) Does not interfere with the flow of food or personnel; and

(iii) Does not afford harborage for rodents or insects;

(4) In refrigeration units, the food is placed to permit free circulation of cold air;

(5) Except where food packaging prevents the entry of water, packaged food is not stored in contact with water or un- drained ice;

(6) Food is not stored in locker rooms, toilet rooms, dressing rooms, garbage rooms, or mechanical rooms;

(7) Except as provided in §B(8)—(14) of this regulation, the internal temperature of a potentially hazardous food is kept at 41°F or less or 135°F or greater;

(8) In existing refrigeration that can cool the food and maintain the food's internal temperature between 42°F and 45°F, the potentially hazardous food's internal temperature, except as provided in §B(9)—(14) of this regulation, is kept at 45°F or less pending equipment upgrade as set forth in Regulation .15A(6) of this chapter;

(9) If pasteurized crab meat, the crab meat's internal temperature is maintained at 38°F or less;

(10) If potentially hazardous reduced oxygen packaged products, the reduced oxygen packaged food's internal temperature is maintained at:

(a) 38°F or less if refrigeration is the only barrier to control the growth of Clostridium botulinum; or

(b) At a lower temperature if a lower temperature is specified by the food manufacturer;

(11) If shell eggs and shellfish, the eggs and shellfish are stored, displayed, and transported under refrigeration at an internal temperature of 45°F or less;

(12) Except for the service of foods such as ice cream and frozen desserts, frozen food is held at an internal temperature of 0°F or below;

(13) If a whole roast cooked and cooled in accordance with Regulations .10 and .11 of this chapter, the roast is held at an internal temperature of 130°F or above; and

(14) Using holding temperatures and times other than those specified in this section, the holding temperatures and times are:

(a) Scientifically proven to be effective in preventing the growth of foodborne pathogens;

(b) Incorporated into a HACCP plan; and

(c) Submitted to and approved by the Department based on a review that indicates compliance with §B(14)(a) and(b) of this regulation;

C. While displaying and serving food:

(1) Except as provided in §§B(8) and C(3) of this regulation, a potentially hazardous cold food that is placed on display is:

(a) Pre-chilled to an internal temperature of 41°F or below;

(b) Rapidly re-chilled to an internal temperature of 41°F or below if the food has exceeded 41°F for a verifiable period of not more than 2 hours; or

(i) The food has exceeded 41°F for more than 2 hours; or

(ii) The time the food has been out of temperature is not verifiable;

(2) Except as provided in §§B(13) and (14) and C(3) of this regulation, a potentially hazardous hot food that is placed on display is:

(a) Cooked according to Regulation .10 of this chapter;

(b) Rapidly re-heated to an internal temperature of 165°F or above if the food was below 135°F for a verifiable period of not more than 2 hours; and

(i) The food was below 135°F for more than 2 hours; or

(ii) The time the food has been out of temperature is not verifiable;

(3) A potentially hazardous bakery product that is stored at room temperature:

(a) Is manufactured, packaged, and labeled with a sell-by-date only in an approved food processing plant meeting the requirements set forth in COMAR 10.15.04;

(b) Remains in the original package until sold to a consumer; and

(4) Except as provided in §C(5) of this regulation, raw unpackaged food of animal origin is not offered for consumer self-service;

(5) Raw unpackaged foods of animal origin offered for consumer self-service are offered only:

(a) At buffets or salad bars that serve foods of animal origin such as sushi or raw shellfish;

(b) When the foods of animal origin are ready-to-cook individual portions for immediate cooking and consumption on premises, such as for Mongolian barbecue; or

(6) When uncovered food is placed on display in food operations, including buffets and cafeterias, the ready-to-eat food is protected by:

(a) Physical guards;

(b) Separation from potential contaminants; or

(7) During pauses in food preparation or dispensing, utensils such as scoops, spoons, and dippers are stored:

(a) In a running water dipper well that provides a volume of fresh potable water sufficient to maintain the utensil in a sanitary condition;

(b) In hot water that is maintained at 135°F or above;

(d) On a clean portion of the food preparation or cooking equipment, which has been cleaned and sanitized as set forth in Regulation .16 of this chapter; or

(e) In a clean, protected location if the utensils are used with a food that is not potentially hazardous;

(8) Sugar, condiments, seasonings, and dressings are provided for self-service in individual packages or dispensed by methods that protect the food;

(9) Except for packaged non-potentially hazardous foods with the wrapping intact, portions of food once served to a customer are not served again; and

(10) Employees or self-service customers do not reuse soiled tableware, including single service articles:

(a) Except for drinking cups and containers reused by self-service consumers in a manner to prevent cross- contamination;

(b) To provide second portions or refills; or

D. During the transportation of food:

(1) Except as provided in §B(8)—(14) of this regulation, the internal temperature of a potentially hazardous food is maintained at 41°F or below or 135°F or above;

(2) From a food service facility to another location, the requirements set forth in §A(2) of this regulation are met;

(3) Frozen food is maintained at an internal temperature of 0°F or below; and

(4) Food is in covered containers or completely wrapped or packaged to protect against contamination.

.07 Food Protection During Outdoor Preparation and Service.

The person-in-charge shall ensure that:

A. During the use of outdoor cooking equipment, such as a barbeque grill, at a food service facility:

(1) Equipment:

(a) Is used only at the food service facility for immediate service to patrons;

(b) Is located:

(i) On an impermeable surface;

(ii) In close proximity to the food preparation area of the food service facility; and

(iii) Away from parking areas, dumpsters, and patron entrances; and

(2) Food is:

(a) Prepared for outdoor cooking inside the food service facility; and

(b) Protected from contamination during cooking and service; and

B. When preparing beverages outdoors:

(1) Overhead protection is provided;

(2) Protection from contamination during storage is provided for ingredients, including:

(a) Ice;

(b) Drink mixes; and

(3) Containers are protected from contamination during storage; and

(4) Other than when only beer, wine, or soda is offered, a hand washing sink is provided in accordance with Regulation

.18M of this chapter.

.08 Use of Time-Only with Potentially Hazardous Food.

A. The approving authority may approve the use of time-only, rather than time in conjunction with temperature, for food protection as set forth in §B of this regulation.

B. The person-in-charge shall ensure that:

(1) Before using time-only while holding or preparing a potentially hazardous food:

(a) A written request is submitted to and approved by the approving authority for a specific food under specific conditions of preparation and service that includes:

(i) A record-keeping procedure that can verify safety intervention steps; and

(ii) Procedures for marking or otherwise identifying the food with the time by which it is to be either used or discarded; and

(b) The procedures for time-only are included in the food service facility's HACCP plan as a critical control point;

(2) Time-only is not used for a:

(a) Potentially hazardous food that is ready-to-eat following a cook and cool cycle;

(b) Raw, ready-to-eat potentially hazardous food such as sliced melon and sprouts; or

(3) Except as otherwise approved by the approving authority, the maximum time limit under time-only control is:

(a) 4 hours for a raw, potentially hazardous food during preparation, after which time the food is cooked or discarded;

(b) 2 hours for a ready-to-eat potentially hazardous food held for consumption directly after cooking, after which time the food not served is discarded; or

(c) 2 hours for a commercially pasteurized and commercially sterile ready-to-eat potentially hazardous food from hermetically sealed packages, after which time the food not served is discarded; and

(4) Food that has been protected using time-only control is not:

(a) Served in a health care facility; or

(b) Reused.

.09 Food Preparation—Temperature and Cross-Contamination Control.

The person-in-charge shall ensure that:

A. Food temperature measuring devices are:

(1) Used to monitor the temperature of potentially hazardous foods;

(2) Graduated and accurate within plus or minus 2°F;

(3) Calibrated annually or more frequently; and

(4) Cleaned and sanitized between uses in different foods to prevent cross-contamination;

B. The storage, thawing, cooking, cooling, reheating, and holding of a food:

(1) Are safe; and

(2) Comply with this chapter;

C. When potentially hazardous food is removed from temperature control for a necessary period of preparation, such as portioning, slicing, or mixing:

(1) The time that the food is out of temperature control is minimized; and

(2) For a period of not greater than 2 hours, the food is rapidly re-chilled to 41°F except as provided in Regulation

.06B(8) of this chapter;

D. When a recipe in which more than one egg is broken and the eggs are combined and not prepared for immediate service:

(1) The mixture is stored under refrigeration at all times before cooking;

(2) The process is included in the food service facility's HACCP plan as a critical control point; and

(3) The mixture containing eggs is cooked to a minimum internal temperature of 155°F for 15 seconds;

E. Potentially hazardous food is thawed:

(1) In refrigerated units so that the temperature of the food does not exceed 41°F except as provided for in Regulation

.06B(8);

(2) Under potable running water that is at or below 70°F with sufficient force to agitate and float off loose particles;

(3) In a microwave oven only when the food will be immediately cooked in the microwave oven or immediately transferred to conventional cooking facilities as part of a continuous cooking process;

(4) If a potentially hazardous reduced oxygen packaged food:

(a) In the food's airtight package; and

(b) At or below 38°F;

(5) As part of a conventional cooking process; or

(6) By another method acceptable to the approving authority that has been scientifically proven to the approving authority to prevent the bacteriological, physical, or chemical contamination of food;

F. Employees prevent contact of exposed, ready-to-eat food with their bare hands by using:

(1) Gloves as specified under Regulation .14J of this chapter;

(2) Utensils such as:

(a) Tongs;

(b) Spatulas;

(d) Automatic dispensing equipment; and

G. Cross-contamination is prevented by:

(1) Not allowing contact between ready-to-eat and raw foods;

(2) Storing and holding food so that:

(a) Ready-to-eat food is located above or otherwise segregated from raw food; and

(b) A food is protected from plumbing leaks and condensate drippage;

(3) Using separate utensils and work surfaces for ready-to-eat food and foods requiring further preparation;

(4) Cleaning and sanitizing utensils and work surfaces between uses;

(5) Excluding sick workers from food handling in accordance with Regulation .14A and B of this chapter; and

(6) Washing raw fruits and vegetables thoroughly to remove soil and other contaminants before cutting, cooking, or serving, with:

(a) Water; or

(b) Chemicals intended specifically for washing or peeling whole fruits and vegetables as specified in 21 CFR

§173.315.

.10 Food Preparation—Cooking.

A. Except as provided in §§B—E of this regulation, the person-in-charge shall ensure that potentially hazardous food is cooked to the minimum internal temperature and for the specified holding time as follows:

(1) Chart 1. Summary of Minimum Cooking and Reheating Food Temperatures and Holding Times.

FOOD MINIMUM

INTERNAL TEMPERATURE

°F °C

HOLDING TIME AT SPECIFIED TEMPERATURE

Shell eggs. Fish, meat, and all other potentially hazardous foods not specified in Chart 1.

Shell eggs not prepared for immediate service, ratites, comminuted fish and meats, game animals commercially raised for food, and injected meats.

Whole roasts (beef, corned beef, pork and cured pork roasts such as ham). Holding time may include post oven heat rise.

Minimum oven temperature for roasts greater than 10 pounds is 250°F for dry

145 63 15 seconds

145 63 3 minutes or

150 66 1 minute or

155 68 15 seconds or

158 70 < 1 second

130 54.4 112 minutes or

131 55 89 minutes or

133	or	56.1	56 minutes
135		57.2	36 minutes
	or
136		57.8	28 minutes
	or
138		58.9	18 minutes
	or
140		60	12 minutes
	or
142		61.1	8 minutes
	or
144		62.2	5 minutes
	or
145		62.8	4 minutes
	or
147		63.9	134 seconds
	or
151		66.1	54 seconds
	or
155		68.3	22 seconds
	or
158		70	none
165		74	15 seconds

heat. For roasts less than 10 pounds, minimum oven temperatures are 350°F for dry heat and 325°F for convection ovens. Oven temperature may be 250°F or less for high humidity cooking (relative humidity greater that 90 percent for at least 1 hour or in a moisture impermeable bag that provides 100 percent humidity).

Poultry; stuffed meat, pasta, or poultry, and exotic bird species; wild game animals; and stuffing containing fish, meat, or poultry. Reheat of leftovers for hot holding.

165

Hold for 2 minutes after

removing from microwave oven.

135

None

Raw foods of animal origin cooked in a microwave oven.

Fruits and vegetables cooked for hot holding, ready-to-eat commercially processed foods, and hot holding.

Ready-to-eat commercially processed foods for immediate service.

(2) A minimum internal temperature of 145°F for 15 seconds for:

(a) Shell eggs prepared for immediate service;

(b) Fish;

(d) All other potentially hazardous food not specified in §A(3)—(7) of this regulation;

(3) A minimum internal temperature of 155°F for 15 seconds or as specified in §A(1) of this regulation for:

(a) Shell eggs not prepared for immediate service;

(b) Ratites;

(d) Game animals commercially raised for food; and

(e) Injected meats;

(4) A minimum internal temperature of 130°F for 112 minutes or as specified in §A(1) of this chapter for:

(a) Whole or corned beef; and

(b) Pork and cured pork roasts;

(5) A minimum internal temperature of 165°F for 15 seconds for:

(a) Poultry;

(b) Stuffed meat, pasta, or poultry;

(d) Wild game animals; and

(e) Stuffing containing fish, meat, or poultry;

(6) A minimum internal temperature of 165°F and held for 2 minutes after removing from the oven for raw animal foods that are cooked in a microwave oven; and

(7) A minimum internal temperature of 135°F for fruits and vegetables and ready-to-eat commercially processed foods cooked for hot holding.

B. The Department may approve cooking times and temperatures other than those specified in §A of this regulation, if the cooking times and temperatures are scientifically proven to the Department to be as effective in killing foodborne pathogens as those specified in §A of this regulation.

C. The person-in-charge may serve a consumer:

(1) Undercooked seared beefsteak upon individual consumer request when:

(a) Only whole muscle, intact beefsteak, is prepared only for immediate service;

(b) The meat is seared continuously on both top and bottom utilizing a heating environment that:

(i) Imparts a temperature at the surface of the intact steak of at least 145°F for 15 seconds; and

(ii) Achieves a cooked color change on all external surfaces; and

(c) A HACCP plan specifically developed for undercooked seared beefsteak is submitted and approved by the approving authority; and

(2) A food that is cooked, cooled, and then refrigerated in accordance with this chapter, such as roast beef for a sandwich, cold or warmed to any desired temperature for immediate consumption.

D. A health care facility may not serve a raw or undercooked animal food.

E. The person-in-charge shall ensure that, except for yellowfin, Northern or Southern bluefin, bigeye tuna, and molluscan shellfish, fish that is to be served raw or undercooked is processed to destroy parasites by freezing to a temperature of:

(1) -4°F or below and stored at -4°F for a minimum of 168 hours;

(2) -31°F or below and stored at -31°F for a minimum of 15 hours; or

(3) -31°F or below and stored at -4°F for a minimum of 24 hours.

F. The person-in-charge shall ensure that a consumer advisory is issued when an animal food, such as beef, eggs, fish, lamb, pork, poultry, or shellfish, is served raw or undercooked by:

(1) Providing a written notification on:

(a) A menu or brochure;

(b) A deli case or menu board;

(d) A table tent or placard; or

(e) Another written means that is visible and legible to the consumer;

(2) Identifying food items on the items set forth in §F(1) of this regulation with an asterisk to a footnote that states the item:

(a) Is served raw;

(b) Is served undercooked;

(d) Contains raw or undercooked ingredients; and

(3) Providing this written statement: "Consuming raw or undercooked animal foods may increase your risk of contracting a foodborne illness, especially if you have certain medical conditions."

.11 Food Preparation—Cooling and Reheating of Potentially Hazardous Foods.

The person-in-charge shall ensure that:

A. Except as specified in Regulation .06B(8) of this chapter, a:

(1) Potentially hazardous cooked food's internal temperature is cooled from 135°F to 70°F within 2 hours and from 70°F to 41°F or less within an additional 4 hours; and

(2) Ready-to-eat potentially hazardous food for cold service, such as reconstituted foods, salads, and canned meat, are cooled to an internal temperature of 41°F within 4 hours;

B. Cooling of potentially hazardous food is accomplished using one or a combination of the following methods:

(1) Refrigerate in shallow pans with food not over 3 inches deep;

(2) Reduce food mass by separating foods into smaller or thinner portions;

(3) Use rapid cooling equipment;

(4) Use ice water baths combined with frequent stirring;

(5) Use containers that facilitate heat transfer;

(6) Add ice made from potable water as an ingredient;

(7) Refrigerate loosely covered or allow the food to remain uncovered until cooled if the food is protected from overhead contamination; or

(8) Another effective method acceptable to the approving authority based on applicable state and local laws, regulations, and ordinances; and

C. Potentially hazardous food is reheated:

(1) Within 2 hours to a minimum internal temperature of 165°F for 15 seconds for food that is cooked, cooled, and refrigerated before being placed into hot food holding equipment;

(2) To a minimum internal temperature of 135°F for 15 seconds for ready-to-eat food taken from a commercially processed, hermetically sealed container or from an intact package from a food processing plant that is inspected by a food regulatory authority for hot holding;

(3) Using the same time and temperature conditions specified in Regulation .10A of this chapter for initial cooking for remaining unsliced portions of roasts for hot holding; and

(4) Within 2 hours or less, to a minimum internal temperature of 165°F for 15 seconds in a microwave oven for hot holding and then stirred, covered, and allowed to stand covered for 2 minutes after reheating.

.12 Food Labeling.

A. The person-in-charge shall ensure that:

(1) Except as specified in §B of this regulation, each item of packaged food has a label containing the following information:

(a) The common name of the food or a descriptive identity statement;

(b) If made from two or more ingredients:

(i) A list of ingredients in descending order of prominence by weight; and

(ii) A declaration of artificial color or flavor and chemical preservatives;

(d) The name and place of business of the manufacturer, packer, or distributor;

(e) Except as exempted in 21 U.S.C. §343(q)(3)—(5), the nutrition labeling specified in 21 CFR Part 101 and 9 CFR Part 317; and

(f) The name of the food source for each major food allergen that is contained in the food unless the food source is already part of the common or usual name of the respective ingredient;

(2) The use of canthaxanthin as a color additive in salmonid fish is disclosed by written means, such as a counter card;

(3) Bulk food available for consumer self-dispensing is prominently labeled with the following information in plain view of the consumer:

(a) The manufacturer's label that was provided with the food; or

(b) A card, sign, or other method of notification that includes the information specified in §A(1), (a), (b), and (f) of this regulation.

B. A food service facility may offer for sale bulk, unpackaged foods such as bakery products and unpackaged foods that are portioned to consumer specification without a label if:

(1) A health, nutrient, or other claim relating to the unpackaged food is not made on a card or sign; and

(2) The food is manufactured or prepared on the premises of the food service facility or at another food service facility owned by the same person.

.13 Food Protection from Poisonous or Toxic Materials.

The person-in-charge shall ensure that:

A. Except for packaged poisonous or toxic products offered in their unopened original containers for retail sale, only poisonous or toxic materials needed to maintain sanitary conditions and to sanitize equipment and utensils are located in a food or food utensil area;

B. A container of a poisonous or toxic material is:

(1) Kept in the original bulk container before use;

(2) Prominently and distinctively marked or labeled for easy identification; and

(3) Used according to the manufacturer's directions;

C. When not in use, poisonous or toxic materials are stored in a:

(1) Cabinet used for no other purpose; or

(2) Room not used for food storage, food preparation, or equipment and utensil washing or storage;

D. A bactericide, cleaning compound, or other compound intended for use on food-contact surfaces is not:

(1) Stored in the same cabinet with an insecticide, rodenticide, or other poisonous or toxic material; or

(2) Used or stored in a way that will leave a toxic residue on food-contact surfaces;

E. A poisonous or toxic material is not used or stored in a way that will:

(1) Contaminate:

(a) Food; or

(b) Food equipment; or

(2) Constitute a potential hazard to:

(a) Employees; or

(b) Customers;

F. A medication is not stored in a food storage, preparation, processing, or service area;

G. First aid supplies are stored in a way that prevents contamination of:

(1) Food; or

(2) Food-contact surfaces; and

H. A container previously used to store poisonous or toxic materials is not used to store, transport, or dispense:

(1) Food; or

(2) Items that will come into contact with food.

.14 Personnel Health and Sanitation.

The person-in-charge shall ensure that:

A. As set forth in COMAR 10.06.01.06E, a food handler does not serve or handle food intended for public consumption if the food handler:

(1) Has any of the following diseases:

(a) Diarrhea caused by Entamoeba histolytica;

(b) Cholera;

(d) E. coli O157:H7;

(e) Hepatitis A;

(f) Diarrhea caused by Salmonella;

(g) Shigellosis;

(h) Streptococcal infection caused by group A beta-hemolytic Streptococcus; or

(i) Typhoid fever; or

(2) Is a carrier of Salmonella Typhi;

B. An employee experiencing persistent sneezing, coughing, or a runny nose that causes discharges from the eyes, nose, or mouth does not work with:

(1) Exposed food;

(2) Clean equipment, utensils, and linens; or

(3) Unwrapped single service or single use articles;

C. An employee who has a disease that may be transmissible through food reports the condition to the person-in- charge;

D. The approving authority is notified when an employee of a food service facility is known to have or is suspected of having a disease that is transmissible by food;

E. An employee washes hands and exposed arm areas thoroughly with soap and warm water:

(1) Before handling:

(a) Exposed foods; or

(b) Food-contact surfaces;

(2) Before starting work;

(3) As often as required to remove soil and contamination;

(4) After using toilet facilities; and

(5) Before and between glove use;

F. An employee washes hands, exposed portions of the arms, between the fingers, and underneath the fingernails:

(1) With a cleaning compound;

(2) At a hand washing facility that is equipped as specified in Regulation .18L and M of this chapter; and

(3) By:

(a) Vigorously rubbing together the surfaces of lathered hands and arms for at least 20 seconds;

(b) Cleaning under the nails with a brush if needed; and

G. An employee keeps hands clean while engaged in handling food and food-contact surfaces;

H. An employee who handles exposed food and food-contact surfaces:

(1) Keeps fingernails clean and neatly trimmed;

(2) Unless wearing gloves that are in good repair, does not wear fingernail polish or artificial fingernails;

(3) Except for a plain, smooth ring such as a wedding band, does not wear jewelry;

(4) Wears outer garments that are clean;

(5) Uses hairnets, caps, or other effective hair restraints in order to keep hair from contacting food and food-contact surfaces;

(6) Maintains personal cleanliness; and

(7) Except as provided in §L of this regulation, does not eat, drink, or use tobacco in any form while working;

I. An employee does not use bare hands for handling ready-to-eat foods, as set forth in Regulation .09F of this chapter;

J. An employee using gloves to protect exposed food:

(1) Uses gloves only for one task;

(2) Does not use the same gloves while working with ready-to-eat food and raw food; and

(3) Discards used gloves when:

(a) The gloves are damaged or soiled;

(b) An interruption occurs in the operation; or

K. An employee receives training in proper food handling and sanitation as it relates to assigned duties; and

L. When in a food preparation or utensil washing area, an employee:

(1) Drinks only from a covered beverage container; and

(2) Handles the container in a way that prevents contamination of:

(a) The employee's hands;

(b) Exposed food;

(d) Utensils;

(e) Linens; and

(f) Unwrapped single service and single use articles.

.15 Food Equipment and Utensils.

A. The person-in-charge shall ensure that:

(1) Except as provided in §§A(2), (6), (15), and (16) and B of this regulation, food equipment meets one or more of the following design standards:

(a) National Sanitation Foundation (NSF) or equivalent sanitation certification from:

(i) The Etlsemko division of Intertek Group PLC (Intertek ETL SEMKO);

(ii) Canadian Standards Association (CSA); or

(iii) Underwriters Laboratories (UL);

(b) Baking Industry Sanitation Standards Committee;

(d) International Association of Milk and Food Sanitarian's "3-A Sanitary Standards"; or

(e) Another applicable published standard acceptable to the approving authority;

(2) When design standards conflict with State laws, codes, or regulations, the State laws, codes, or regulations are followed;

(3) Equipment and utensils are designed, constructed, and maintained to:

(a) Accomplish the intended and required functions;

(b) Protect food from internal and external contamination;

(d) Be resistant to:

(i) Denting;

(ii) Buckling;

(iii) Pitting;

(iv) Chipping;

(v) Crazing; and

(vi) Excessive wear;

(e) Have non-food contact surfaces where exposed to splash, food debris, or other soils that are:

(i) Smooth;

(ii) Washable; and

(iii) Readily accessible;

(f) Withstand repeated scrubbing, scouring, corrosive action of food, cleansers, and sanitizing agents; and

(g) Prevent harboring of soils, bacteria, or pests:

(i) In or on the equipment; and

(ii) Between the equipment and other equipment, floors, walls, or supports;

(4) Materials used as food contact surfaces of equipment are:

(a) Nontoxic;

(b) Unable to contaminate or be absorbed by food under the conditions of use;

(d) Except for the use of cast iron as a food contact material if the surface is to be heated, corrosion resistant;

(5) Food contact surfaces of equipment and utensils are designed, constructed, and maintained to be:

(a) Smooth;

(b) Easily cleanable;

(d) Free of difficult to clean internal corners and crevices;

(e) Self-emptying or self-draining if an interior surface;

(f) Visible or readily disassembled for inspection; and

(g) Readily:

(i) Accessible for manual cleaning without tools; or

(ii) Disassembled with the use of simple tools kept available near the equipment;

(6) Existing refrigeration equipment used to maintain potentially hazardous foods that is incapable of maintaining the potentially hazardous food at 41°F or less is upgraded or replaced within 5 years of the effective date of this chapter;

(7) Equipment designed for pressurized cleaning-in-place is designed, constructed, and maintained to:

(a) Fully circulate cleaning and sanitizing solutions through a fixed system in which the solutions will contact all interior food contact surfaces;

(b) Self-drain or otherwise completely evacuate all cleaning solutions; and

(8) Cutting blocks, bakers tables, and similar wood food contact surfaces are made from:

(a) Hard maple; or

(b) Another material that is:

(i) Nontoxic;

(ii) Smooth; and

(iii) Free of cracks, crevices, and open seams;

(9) Lubricants used on bearings and gears of equipment are food-grade;

(10) Except for equipment that is portable, equipment that is placed on tables or counters is:

(a) Sealed in place;

(b) Mounted on legs or feet at least 4 inches high; or

(11) Floor-mounted equipment is:

(a) Elevated:

(i) At least 6 inches above the floor; and

(ii) So that food contact surfaces are at least 18 inches above the floor; and

(b) Placed so that there is sufficient space for cleaning between:

(i) Adjoining units; and

(ii) A unit and the adjacent walls;

(12) The spaces between adjoining equipment are closed and sealed if exposed to seepage;

(13) Aisles or working spaces between equipment and between equipment and walls are:

(a) Unobstructed and of sufficient width to permit employees to perform duties without contaminating food or food- contact surfaces by clothing or personal contact; and

(b) In a new facility or a facility that is remodeled, a minimum width of:

(i) 3 feet where food preparation occurs on only one side of the aisle;

(ii) 4 feet where food preparation occurs on both sides of the aisle and employees work back to back;

(iii) 5 feet where food preparation occurs on both sides of the aisle, employees work back to back, and other employees must pass through the area; or

(iv) Another width approved by the approving authority based on a review that indicates compliance with §A(13)(a) of this regulation;

(14) Equipment is installed and located to limit the potential for cross-contamination of food;

(15) Existing equipment installed in a food service facility before the effective date of this chapter:

(a) Complies with §A(3)—(14) of this regulation; and

(b) Is located to prevent:

(i) The cross-contamination of food: and

(ii) Insanitary conditions;

(16) When an existing piece of equipment ceases to operate:

(a) Equipment intended for temporary use is:

(i) Acceptable to the approving authority; and

(ii) Complies with §A(3)—(9) of this regulation;

(b) Replaced:

(i) With equipment that meets the requirements of this regulation; and

(ii) Within 30 working days from the date the permanent replacement plan required in §A(16)(c) of this regulation is accepted by the approving authority; and

(c) The approving authority is provided plans for permanent replacement of the failed unit within 10 working days after the failure of the unit; and

(17) A vending machine containing potentially hazardous foods has an automatic control that prevents the machine from vending food:

(a) If there is a power failure, mechanical failure, or other condition resulting in an internal machine temperature that cannot maintain food temperatures as specified in Regulation .06B(7) of this chapter; and

(b) Until serviced and working properly.

B. The approving authority may allow the use of equipment that meets §A(3)—(11) of this regulation but fails to comply with §A(1) of this regulation if:

(1) An applicable published equipment standard does not exist; and

(2) A review indicates the equipment and its use are:

(a) Not harmful to public health; and

(b) Consistent with industry standards and practice.

.16 Cleaning and Sanitizing Equipment and Utensils.

The person-in-charge shall ensure that:

A. Food contact surfaces of equipment and utensils are effectively cleaned and sanitized by:

(1) Removing soil and food particles by one or more of the following:

(a) Flushing;

(b) Soaking;

(2) Cleaning with a suitable commercial detergent;

(3) Rinsing with potable water; and

(4) Sanitizing, using:

(a) Immersion in hot water of 170°F or higher temperature for at least 30 seconds;

(b) A chemical sanitizer that is proven to kill pathogens effectively:

(i) In accordance with the manufacturer's label use instructions; or

(ii) As set forth in §C(1) of this regulation; or

(i) Live steam from a hose, provided that the steam can be confined within the equipment;

(ii) A rinse with boiling water; or

(iii) A spray or swab with a chemical sanitizing solution of at least twice the minimum strength stated in §C(1) of this regulation;

B. Cleaning and sanitization occur:

(1) As often as needed to prevent food contamination;

(2) After each use;

(3) Between an interruption in food preparation greater than 4 hours; and

(4) Except for food contact surfaces of equipment or utensils within holding units that are maintained at proper temperatures, after a continuous use of 4 hours;

C. When sanitizer is used for the manual sanitization of food contact surfaces of equipment and utensils:

(1) The minimum level of sanitizer provided is:

(a) 50 parts per million chlorine with a minimum water temperature of 75°F and a minimum contact time of 7 seconds;

(b) 12.5—25 parts per million iodine with a minimum water temperature of 75°F and a minimum contact time of 30 seconds; or

(c) The concentration indicated on the manufacturer's label with a minimum contact time of 30 seconds for quaternary ammonium compound; and

(2) A test kit or other device that accurately measures concentration of the sanitizer in parts per million is provided and used to check that the minimum level of sanitizer is accurate;

D. When hot water is used as the sanitizing agent in manual operations, a graduated thermometer is provided that is:

(1) Accurate within plus or minus 2°F;

(2) Calibrated annually or more frequently;

(3) Located near the sink; and

(4) Used frequently to check water temperature;

E. A three-compartment sink is:

(1) Provided and used wherever warewashing is conducted manually;

(2) Adequate in length, width, and depth to accommodate the largest equipment items and utensils;

(3) Supplied with hot and cold running water at each sink compartment; and

(4) If used for tasks other than warewashing, such as washing wiping cloths or produce or thawing food:

(a) Is washed and sanitized before and after the sink is used for a different task; and

(b) Does not contain an automatic chemical dispenser;

F. Single compartment sinks are used to rinse utensils such as a knife or spatula only if the utensils will subsequently be washed, rinsed, and sanitized;

G. Dish tables or integral drainboards are:

(1) Of adequate size for proper handling of soiled utensils before washing and for cleaned utensils following rinsing or sanitization;

(2) Located and constructed so the tables or drainboards do not interfere with the proper use of the warewashing facilities; and

(3) Not required for cooks' and bakers' rinse sinks;

H. When spray-type warewashing machines are used:

(1) The machines are installed:

(a) According to manufacturer's specifications; and

(b) To provide effective cleaning and sanitization of equipment and utensils;

(2) The manufacturer's specifications are listed on a data plate that is permanently affixed to the machine;

(3) If manufacturer's specifications for wash and rinse water temperature do not exist, the following standards are followed:

(a) For machines using chemical sanitization, the wash and final rinse water temperature is at least 120°F; or

(b) For machines using hot water sanitization, the wash water is at least:

(i) 160°F for single tank conveyor machines; and

(ii) 150°F for other types of machines;

(i) 180°F at the entrance of the manifold; or

(ii) 160°F when a pumped rinse is provided;

(d) Wash water is kept clean and rinse water tanks are protected by:

(i) Distance;

(ii) Baffles; or

(iii) Other means to minimize the entry of wash water into the rinse water;

(e) The flow pressure is not less than 15 or more than 25 pounds per square inch on the water line immediately adjacent to the final rinse control valve;

(f) Except for a pumped or recirculated final rinse, a pressure gauge is provided immediately upstream from the final rinse control valve to check the flow pressure of the final rinse water; and

(g) An easily readable thermometer is provided to measure water temperature with an accuracy of plus or minus 2°F:

(i) In each tank of the warewashing machine; and

(ii) As the final rinse water enters the manifold;

(4) Jets, nozzles, and all other parts of each machine are maintained free of:

(a) Chemical deposits;

(b) Debris; and

(5) If used, automatic detergent dispensers are maintained and operating;

I. All warewashing machines are thoroughly cleaned as often as needed throughout the day to:

(1) Prevent recontamination of equipment and utensils; and

(2) Ensure that the equipment performs the equipment's intended function;

J. A pre-rinse device is provided for all warewashing machines;

K. Equipment and utensils are placed in racks, trays, baskets, or on conveyors after flushing, scraping, or soaking so that food contact surfaces are:

(1) Subject to unobstructed application of detergent wash;

(2) Rinsed thoroughly with clean rinse water to remove particulate matter and detergent residues; and

(3) Drained;

L. Warewashing machines using chemicals for sanitization meet the following additional requirements:

(1) Chemicals added for sanitization purposes are automatically dispensed; and

(2) The chemical sanitizer used:

(a) Is listed in 21 CFR §178.1010; and

(b) Provides the equivalent bactericidal effect of a solution containing at least 50 parts per million of chlorine; and

(3) A test kit or other device that accurately measures the concentration of the sanitizing solution is used;

M. Written approval is obtained from the approving authority when any other type of machine, device, or facilities and procedures for warewashing will be used based on a review that indicates compliance with §A of this regulation;

N. Non-food contact surfaces of equipment are cleaned frequently enough to preclude the accumulation of soil residues; and

O. Wiping cloths are:

(1) Used only for wiping food spills;

(2) Free of food debris when used dry for wiping food spills on tableware; and

(3) Rinsed and stored in one of the sanitizing solutions specified in §C(1) of this regulation when used wet for wiping spills from the surfaces of equipment.

.17 Storage and Handling of Cleaned Equipment and Utensils.

The person-in-charge shall ensure that:

A. Contamination of food-contact surfaces of cleaned and sanitized equipment and utensils is prevented by handling:

(1) Cleaned spoons, knives, and forks by the utensil's handles only; and

(2) Cleaned cups, glasses, and bowls so that hands do not contact inside surfaces or mouth-contact surfaces;

B. The food-contact surfaces of equipment are protected from:

(1) Splash;

(2) Dust; and

(3) Other contamination;

C. Cleaned and sanitized food equipment, portable equipment, and utensils are stored:

(1) A minimum of 18 inches above the floor when not fully protected by an enclosure with doors;

(2) In a clean, dry location; and

(3) In a space that affords protection from splash, dust, and other contamination;

D. Utensils are:

(1) Air dried before being stored; or

(2) Stored in a self-draining position on hooks or racks constructed of a corrosion resistant material;

E. Stored containers and utensils are covered or inverted whenever possible;

F. Flatware is stored in containers designed to present the handle to the employee or customer;

G. Toilet rooms or vestibules are not used to store:

(1) Food;

(2) Food equipment;

(3) Utensils; or

(4) Single service articles; and

H. Single service articles are:

(1) Stored in closed cartons or containers to protect the articles from contamination;

(2) Handled and dispensed in a manner that prevents contamination of surfaces that come into contact with food or the mouth of the user; and

(3) Used only once.

.18 Control of Sanitary Facilities.

The person-in-charge shall ensure that:

A. Potable water is:

(1) Obtained from a water supply system that complies with Environment Article, Title 9, Annotated Code of Maryland, and COMAR 26.04.04; and

(2) Meets the standards of quality specified in Environment Article, Title 9, Annotated Code of Maryland, and COMAR 26.04.01;

B. Non-potable water for non-culinary purposes such as air conditioning or fire protection is used only if the system complies with §H(3) of this regulation;

C. Except for a temporary food service facility where water under pressure is not available, hot and cold running water under pressure is provided:

(1) In all areas where:

(a) Food is prepared; and

(b) Equipment and utensils are washed; and

(2) With sufficient water capacity, pressure, and hot water generation and distribution to meet peak demands throughout the facility;

D. Drinking water, if not dispensed through the water supply system of the food service facility, is potable and stored in a container that meets all applicable laws, ordinances, and regulations;

E. Steam that contacts food is free from deleterious or harmful matter that might adulterate food;

F. All water-carried sewage is disposed of by:

(1) A public sewerage system; or

(2) An approved sewage disposal system constructed and operated in conformance with applicable State and local laws, ordinances, and regulations;