For the purpose of this subchapter:

(1) "Adulterated" means a food:

(a) that bears or contains any poisonous or deleterious substance in a quantity which may render it injurious to health;

(b) that bears or contains any added poisonous or deleterious substance for which no safe tolerance has been established by laws or rules or in excess of such tolerance if one has been established;

(c) that consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for human consumption;

(d) that has been processed, prepared, packed or held under unsanitary conditions, whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;

(e) that is in whole or in part a product of a diseased animal, or an animal which has died otherwise than by slaughter;

(f) whose container is composed in whole or in part of any poisonous or deleterious substance which may render the contents injurious to health; or

(g) as otherwise determined to be "adulterated" under the Montana Food, Drug and Cosmetic Act, 50-31-202 , MCA.

(2) "Approved" means acceptable to the regulatory authority based on its determination of conformity with safe food manufacturing and processing methods.

(3) "Aw" means water activity which is a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

(4) "Beverage" means a liquid for drinking, including water.

(5) "Certification number" means a unique combination of letters and numbers assigned by a shellfish control authority to a molluscan shellfish dealer according to the provisions of the federally-regulated national shellfish sanitation program.

(6) "Code of Federal Regulations (CFR) " means the compilation of general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government.

(7) "Comminuted" means reduced in size by methods that include chopping, flaking, grinding, or mincing; fish or meat products that are reduced in size and restructured or reformulated, such as gefilte fish, formed roast beef, gyros, ground beef, and sausage; and a mixture of two or more types of meat that have been reduced in size and combined, such as sausages made from two or more meats.

(8) "Consumer" means a person who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food establishment, and does not offer the food for resale;

(9) "Corrosion resistant material" means a material that maintains an easily cleanable surface under prolonged influence of the food to be contacted, the normal use of cleaning compounds and sanitizing solutions, and other conditions-of-use environment.

(10) "Critical control point" means part of a food safety evaluation process, such as a HACCP plan, where loss of control may result in an unacceptable health risk.

(11) "Critical item" means a provision of this subchapter that, if violated, is more likely than other violations to contribute to food contamination, illness, or environmental degradation.

(12) "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 so that the identified food safety hazard may not occur.

(13) "Department" means the department of public health and human services.

(14) "Dry storage area" means a room or area designated for the storage of packaged or containerized bulk food that is not potentially hazardous and dry goods such as single-service items.

(15) "Easily cleanable" means a surface whose material, design, construction, and installation allows effective removal of soil by normal cleaning methods.

(16) "Easily movable" means any item that:

(a) weighs 50 pounds (23 kilograms) or less; is mounted on casters, gliders, or rollers; or is provided with a mechanical means requiring no more than 50 pounds (23 kilograms) of force to safely tilt a unit of equipment for cleaning; and

(b) has no utility connection, a utility connection that disconnects quickly, or a flexible utility connection line of sufficient length to allow the equipment to be moved for cleaning of the equipment and adjacent area.

(17) "EPA" means the federal environmental protection agency.

(18) "Equipment" means items, other than utensils, used in the operation of a food establishment, including stoves, ovens, ranges, hoods, slicers, mixers, meat blocks, tables, boxes counters, refrigerators, sinks, dishwashing machines, steam tables, proof boxes and freezers.

(19) "Exotic species" means an animal that comes from or that is commonly found in another part of the world or in a foreign country. Cattle, sheep, swine, goats, and poultry are not considered exotic species.

(20) "Fish" means edible forms of aquatic animal life other than birds or mammals, encompassing both fresh and saltwater forms, and including molluscan shellfish and crustaceans.

(21) "Food" means a raw, cooked, or processed edible substance, beverage, or ingredient used, intended for use, or for sale in whole or in part for human consumption.

(22) "Food borne disease outbreak" means illness experienced by two or more persons after ingestion of a common food which an epidemiological analysis implicates as the source of the illness, a single case of illness from botulism, or chemical poisoning.

(23) "Food contact surfaces" means those surfaces of equipment or utensils with which food normally comes in contact, and those surfaces from which food may drain, drip, or splash into or onto food or surfaces normally in contact with food.

(24) "Food employee" means an individual working with unpackaged food, food equipment or utensils, or food-contact surfaces.

(25) "Food manufacturing establishment" means a commercial establishment and buildings or structures in connection with it, used to manufacture or prepare food for sale for human consumption, but does not include milk producers' facilities, milk pasteurization facilities, milk product manufacturing plants, slaughterhouses, or meat packing plants; a food manufacturing establishment does not provide food directly to a consumer, and does not include a food service establishment as defined in this rule.

(26) "Food service establishment" means an operation defined in 50-50-102 (8) , MCA, and includes an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption in a mobile, stationary, temporary, semipermanent or permanent facility or location; where consumption is on or off the premises and regardless of whether there is a charge for the food. Food service establishment does not include:

(a) an establishment, vendor, or vending machine that sells or serves only non-perishable foods;

(b) an establishment that offers only prepackaged foods that are not potentially hazardous;

(c) a produce stand that only offers whole, uncut fresh fruits and vegetables;

(d) a food manufacturing establishment;

(e) a kitchen in a private home if the food is prepared for sale or service at a function such as a religious or charitable organization's bake sale;

(f) a private home that receives catered or home-delivered food; or

(g) a private organization serving food to only its members.

(27) "Game animal" means an animal, the products of which are food, that is not classified as cattle, sheep, swine, goat, poultry, fish or ratites such as ostrich, emu, and rhea; but includes mammals such as reindeer, elk, deer, antelope, water buffalo, bison, rabbit, squirrel, opossum, raccoon, nutria or muskrat, and nonaquatic reptiles such as land snakes.

(28) "HACCP plan" means a written document that delineates the formal procedures for following the hazard analysis critical control point principles developed by the national advisory committee on microbiological criteria for foods.

(29) "Hazard" means a biological, chemical, or physical property that may cause an unacceptable consumer health risk.

(30) "Hermetically sealed container" means a container that is designed and made to be secure against the entry of microorganisms and in the case of low acid canned foods, to maintain the sterility of its content after processing.

(31) "Highly susceptible population" means a group of persons who are more likely than other populations to experience food borne disease because they have weak immune systems; such as patients and residents in a health care facility as provided in Title 50, chapter 5, MCA; older adults being served by such programs as meals on wheels, senior citizen centers, or similar programs; and children of preschool age in a day care center as provided in ARM Title 37, chapter 95.

(32) "Injected meat" means meat that has been manipulated, such as through tenderizing or inserting juices, that allows infectious or toxigenic microorganisms to be introduced from the meat's surface to its interior.

(33) "Kitchenware" means all multiuse utensils other than tableware used in the storage, preparation, conveying or serving of food.

(34) "Law" means applicable federal, state, and local statutes, ordinances, rules and regulations.

(35) "License" means a document issued by the department that authorizes a person or persons to operate a food service establishment, mobile food service establishment, or temporary food service establishment.

(36) "Linens" means fabric items such as cloth hampers, cloth napkins, table cloths, wiping cloths, and work garments, including cloth gloves.

(37) "Local health authority" means a local board of health established in accordance with Title 50, chapter 2, MCA, and its employees, or the local health officer or the local sanitarian.

(38) "Meat" means the flesh of animals used as food, including the dressed flesh of cattle, swine, sheep, goats, bison, and other edible animals, except fish and poultry, that is offered for human consumption.

(39) "Mg/L" means milligrams per liter, which is the metric equivalent of parts per million (ppm) .

(40) "Mobile food service" means a vehicle-mounted food establishment designed to be readily movable.

(41) "Molluscan shellfish" means any edible species of fresh or frozen oysters, clams, mussels, and scallops, or their edible portions, but does not include the shucked adductor muscle of the scallop used alone.

(42) "Other authorized persons" means those persons working in a food service establishment that are allowed on the premises by the licensee or person in charge.

(43) "Packaged" means bottled, canned, cartoned, or securely wrapped, but does not include the wrapper, carry-out box, or other nondurable container used to protect the food during service and receipt of the food by the consumer.

(44) "Perishable food" means any food of such type or in such condition as may spoil.

(45) "Perishable food vending machine" means a self-servicing device that, upon insertion of a coin, paper currency, token, card, or key, dispenses packaged perishable food.

(46) "Person" means an individual, partnership, corporation, association, cooperative group, or other entity engaged in operating, owning, or offering services of an establishment.

(47) "Person in charge" means the individual present in the food service establishment who is the apparent supervisor of the food service establishment at the time of inspection. If no individual is the apparent supervisor, then any food employee present is the person in charge.

(48) "Personal care items" means items or substances that may be poisonous, toxic, or a source of contamination that are used to maintain or enhance a person's health, hygiene, or appearance, including medicines, first aid supplies, cosmetics, and toiletries such as toothpaste and mouthwash.

(49) "pH" means the symbol for the negative logarithm of the hydrogen ion concentration, which is a measure of the degree of acidity or alkalinity of a solution, with values between 0 and 7 indicating acidity, values between 7 and 14 indicating alkalinity, and the value of 7 considered neutral.

(50) "Physical facilities" means the structure and interior surfaces of a food establishment, including accessories such as soap and towel dispensers and attachments such as light fixtures and heating or air conditioning system vents.

(51) "Potentially hazardous food" means:

(a) a food that is a natural or synthetic and is in a form capable of supporting:

(i) the rapid and progressive growth of infectious or toxigenic micro-organisms;

(ii) the growth and toxin production of Clostridium botulism; or

(iii) in raw shell eggs, the growth of Salmonella enteritidis;

(b) a food of animal origin that is raw or heat-treated; a food of plant origin that is heat-treated or consists of raw seed sprouts, cut melons; and garlic and oil mixtures;

(c) potentially hazardous food, which does not include:

(i) an air-cooled, hard-boiled egg with intact shell;

(ii) a food with a water activity (aw) value of 0.85 or less;

(iii) a food with a hydrogen ion concentration (pH) level of 4.6 or below when measured at 75 E F, (24 E C) ;

(iv) a food, in an unopened hermetically sealed container, that is commercially processed to achieve and maintain commercial sterility under conditions of nonrefrigerated storage and distribution; or

(v) a food for which a variance granted by the department is based upon laboratory evidence demonstrating that rapid and progressive growth of infectious and toxigenic microorganisms or the slower growth of Clostridium botulinum cannot occur.

(52) "Poultry" means any domesticated birds, such as chickens, turkeys, ducks, geese, or guineas, whether live or dead.

(53) "Premises" means the physical facility, its contents, and the contiguous land or property under the control of the license holder; whether it is a stand-alone facility or whether it is only one component of a larger organization, such as a health care facility, hotel, motel, school, recreational camp, or prison.

(54) "Pushcart" means a non-self-propelled vehicle limited to serving non-potentially hazardous food, or wrapped food prepared beforehand in an approved food service establishment or food manufacturing establishment maintained at proper temperatures.

(55) "Ratites" means birds such as ostrich, emu, and rhea.

(56) "Ready-to-eat food" means food that is in a form that is edible without washing, cooking, or additional preparation by the food service establishment or the consumer, and that is reasonably expected to be consumed in that form.

(57) "Reconstituted" means dehydrated food products combined with water or other liquids.

(58) "Reduced-oxygen packaging" means the reduction of the amount of oxygen in a package by mechanically evacuating the oxygen; displacing the oxygen with another gas or combination of gases; or otherwise controlling the oxygen content in a package to a level below that normally found in the surrounding atmosphere, which is 21% oxygen, including altered atmosphere, modified atmosphere, controlled atmosphere, low oxygen, and vacuum packaging, including sous vide.

(59) "Refuse" means solid waste not carried by water through the sewage system, including discarded organic matter, garbage, trash, and other waste materials resulting from the operation of a food establishment.

(60) "Regulatory authority" means the Montana department of public health and human services or the local health authority, established in accordance with Title 50, chapter 2, MCA, and their employees, or the local health officer and/or the local sanitarian.

(61) "Safe temperature" means temperatures of 41 º F (5 º C) or below and 135 º F (57.2 º C) or above for perishable and potentially hazardous foods; 42 º F through 45 º F (5.5 º C through 7 º C) may also be considered safe if existing equipment cannot maintain 41 º F (5 º C) or below and food storage and display is reduced to a maximum of 4 days for ready-to-eat foods.

(62) "Safe materials" means articles manufactured from or composed of materials which may not reasonably be expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of any food. If materials used are food additives or color additives as defined in 50-31-103 (8) and (22) , MCA, of the Montana Food, Drug, and Cosmetic Act, they are "safe" only if they are used in conformity with regulations established pursuant to section 409 or 706 of the applicable sections of the federal Food, Drug and Cosmetic Act. Other materials are "safe" only if, as used, they are not food additives or color additives as defined in 50-31-103 (8) and (22) , MCA, of the Montana Food, Drug, and Cosmetic Act and are used in conformity with all applicable regulations of the federal food and drug administration.

(63) "Sanitization" means the application of accumulative heat or concentration of chemicals on cleaned food contact surfaces that, when evaluated for efficacy, yield a reduction of 5 logarithms, which is equal to 99.999% reduction of representative food borne disease microorganisms.

(64) "Sealed" means free of cracks or other openings that permit the entry or passage of moisture.

(65) "Semipermanent stands" means those establishments which are not mobile and are not on permanent foundations.

(66) "Servicing area" means an operation base location to which a mobile food service, food transportation vehicle or pushcart returns regularly for maintenance such as vehicle and equipment cleaning, discharge of liquid or solid wastes, refilling water tanks and ice bins, and boarding food.

(67) "Sewage" means liquid waste containing animal or vegetable matter in suspension or solution and may contain chemicals in solution.

(68) "Shellstock" means raw, in-shell molluscan shellfish.

(69) "Shucked shellfish" means molluscan shellfish that have one or both shells removed.

(70) "Single-service articles" means cups, containers, lids, closures, plates, knives, forks, spoons, stirrers, paddles, straws, napkins, wrapping materials, toothpicks and other similar articles that are designed and constructed for one-time, one-person use and then discarded.

(71) "Single-use articles" means utensils and bulk food containers designed and constructed to be used once and discarded, including waxed paper, butcher paper, plastic wrap, formed aluminum food containers, jars, plastic tubs or buckets, bread wrappers, pickle barrels, ketchup bottles, and number 10 cans which do not meet the materials, durability, strength, and cleanability specifications for multiuse utensils in ARM 37.110.212 and 37.110.213.

(72) "Smooth" means food contact surfaces or nonfood contact surfaces that are easily cleanable and free of breaks, open seams, cracks, chips, pits, and similar imperfections, including floors, walls, or ceilings that have an even or level surface with no roughness or projections that make it difficult to clean.

(73) "Support animal" means a trained animal, such as a seeing eye dog, that accompanies a person with a disability to assist in managing the disability and enables the person to perform functions that the person would otherwise be unable to perform.

(74) "Tableware" means eating, drinking, and serving utensils for table use, such as flatware, which includes knives, forks, and spoons; and hollowware, which includes bowls, cups, serving dishes, tumblers and plates.

(75) "Temperature measuring device" means a thermocouple, thermistor, or other device that indicates the temperature of food, air, or water.

(76) "Temporary food service establishment" means a food service establishment that operates at a fixed location for a period of time of not more than 14 consecutive days in conjunction with a single event or celebration.

(77) "Utensil" means a food contact implement or container used in the storage, preparation, transportation, dispensing, sale, or service of food, such as kitchenware or tableware that is multiuse, single-service, or single-use; gloves used in contact with food; and food temperature measuring devices.

(78) "Variance" means a written document issued by the regulatory authority that authorizes a modification or waiver of one or more requirements of this subchapter if, in the opinion of the regulatory authority, a health hazard or nuisance will not result from the modification or waiver.

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

(80) "Water supply" means a safe, accessible, and adequate source of water that meets requirements in Title 75, chapter 6, MCA and ARM Title 17, chapter 38 applicable to public water systems.

(81) "Whole muscle intact beef" means whole muscle beef that is not injected, mechanically tenderized, reconstructed, or scored and marinated, from which beef steaks may be cut.