410 IAC 7-21 Definitions

Section 1 Applicability

The definitions in this rule apply throughout this rule.

Section 2 "Acid foods" defined

"Acid foods" means foods that have a natural pH of 4.6 or below.

Section 3 "Acidified foods" defined

  1. "Acidified foods" means low-acid foods to which acid or acid food is added; these foods
    include, but are not limited to:

  1. beans;

  2. cucumbers;

  3. cabbage;

  4. artichokes;

  5. cauliflower;

  6. puddings;

  7. peppers;

  8. tropical fruits; and

  9. fish;

singly or in any combination. They have a water activity (aw) greater than eighty-five hundredths (0.85) and have a finished equilibrium pH of 4.6 or below. These foods may be called pickled, such as "pickled cauliflower."

  1. Excluded from the definition of acidified foods are:

  1. carbonated beverages;

  2. jams;

  3. jellies;

  4. preserves; and

  5. acid foods;

(including such foods as standardized and nonstandardized food dressings and condiment sauces) that contain small amounts of low-acid food and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration.

Section 4 "Adequate" defined

"Adequate" means that which is needed to accomplish the intended purpose in keeping with good public health practice.

Section 5 "Adulterated" defined

"Adulterated" has the meaning set forth under IC 16-42-1 through IC 16-42-4.

Section 6 "Allergen" defined

"Allergen" means foods that are commonly known to cause serious allergenic responses,
including, but not limited to, the following:

  1. Milk.

  2. Eggs.

  3. Fish.

  4. Crustacea.

  5. Mollusks.

  6. Tree nuts.

  7. Wheat.

  8. Legumes, particularly peanuts and soybeans.

Section 7 "Batter" defined

"Batter" means a semifluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods.

Section 8 "Blanching" defined

"Blanching," except for tree nuts and peanuts, means a prepackaging heat treatment of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to affect other physical or biochemical changes in the food.

Section 9 "Bottled drinking water" defined

"Bottled drinking water" means water that is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water.

Section 10 "CFR" defined

"CFR" means the Code of Federal Regulations.

Section 11 "CIP system" defined

"CIP" means cleaned in place by the circulation or flowing by mechanical means through a piping system of a detergent solution, water rinse, and sanitizing solution onto or over equipment surfaces that require cleaning. The term does not include the cleaning of equipment, such as band saws, slicers, or mixers that are subjected to in-place manual cleaning without the use of a CIP system.

Section 12 "Critical control point" defined

"Critical control point" means a point or procedure in a specific food process where loss of control may result in an unacceptable health risk.

Section 13 "Department" defined

"Department" means the Indiana state department of health or its authorized representative.

Section 14 "Drinking water" defined

"Drinking water" means water that meets the requirements of 327 IAC 8. The term is traditionally known as potable water. The term includes "water," except where the term used connotes that the water is not potable, such as boiler water, mop water, wastewater, and nondrinking water.

Section 15 "Food" defined

"Food" means:

  1. All articles used for food, drink, confectionery, or condiment whether simple, mixed, or compound.

  2. All substances or ingredients used in the preparation of the items described in subdivision (1).

Section 16 "Food-contact surface" defined

"Food-contact surface" means a surface of equipment or a utensil:

  1. with which food normally comes into contact; or

  2. from which food may drain, drip, or splash into a food or onto a surface normally in contact with food.

Section 17 "Food employee" defined

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

Section 18 "HACCP plan" defined

"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.

Section 19 "Lot" defined

"Lot" means the food produced during a period of time indicated by a specific code.

Section 20 "Low-acid food" defined

"Low-acid food" means any food, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than eighty-five hundredths (0.85).

Section 21 "Microorganisms" defined

"Microorganisms" means yeasts, molds, bacteria, protozoa and viruses and includes, but is not limited to, species having public health significance. The term "undesirable microorganisms" includes those microorganisms that are of public health significance and those of nonpublic health significance that result in food spoilage or that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated. "Microbial" is used in some instances instead of using an adjectival phrase containing the word microorganism.

Section 22 "Pest" defined

"Pest" refers to any objectionable animals or insects including, but not limited to, the following;

  1. Birds.

  2. Rodents.

  3. Flies.

  4. Larvae.

Section 23 "pH" defined

"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. Values between zero (0) and seven (7) indicate acidity and values between seven (7) and fourteen (14) indicate alkalinity. The value for pure distilled water is seven (7), which is considered neutral.

Section 24 "Plant" defined

"Plant" means the building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling, holding, or storing of human food.

Section 25 "Potentially hazardous food" defined

  1. "Potentially hazardous food" means a natural or synthetic food and requires temperature control because it is in a form capable of supporting the following:

  1. The rapid and progressive growth of infectious or toxigenic microorganisms;

  2. The growth and toxin production of Clostridium botulinum; or

  3. In raw shell eggs, the growth of Salmonella enteritidis.

  1. The term includes:

  1. a food of animal origin that is raw or heat-treated;

  2. a food of plant origin that is heat-treated or consists of raw seed sprouts;

  3. cut melons; and

  4. garlic-in-oil mixtures that are not modified in a way that results in mixtures that do not support growth as specified under subsection (a).

  1. The term does not include any of the following:

  1. An air-cooled hard-boiled egg with shell intact.

  2. A food with an aw value of eighty-five hundredths (0.85) or less.

  3. A food with a pH level of four and six tenths (4.6) or below when measured at seventy five (75) degrees Fahrenheit.

  4. 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.

  5. A food for which laboratory evidence demonstrates that the rapid and progressive growth of infectious or toxigenic microorganisms or the growth of Salmonella enteritidis in eggs or Clostridium botulinum cannot occur, such as a food that:

  1. has an aw and a pH that are above the levels specified under subdivisions (2) and (3) of this rule; and

  2. may contain a preservative, other barrier to the growth of microorganisms, or a combination of barriers that inhibit the growth of microorganisms.

A food that may contain an infectious or toxigenic microorganism or chemical or physical contaminant at a level sufficient to cause illness, but that does not support the growth of microorganisms as specified under subsection (a) of this section.

Section 26 "Public health significance" defined

"Public health significance" means:

  1. the potential for causing diseases with symptoms such as, but not limited to:

    1. diarrhea;

    2. fever;

    3. jaundice;

    4. vomiting or sore throat with fever; or

    5. boils; or

  2. for diseases such as, but not limited to;

    1. Salmonella spp.;

    2. Shigella spp.;

    3. Escherichia coli 0157:H7; or

    4. Hepatitis A virus associated with foodborne or waterborne transmission that are reportable according to 410 IAC 1-2.3.

Section 27 "Quality control operation" defined

"Quality control operation" means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated as defined under IC 16-42-2-2.

Section 28 "Reduced oxygen packaging" defined

  1. "Reduced oxygen packaging" means the following:

  1. The reduction of the amount of oxygen in a package by:

  1. removing oxygen;

  2. displacing oxygen and replacing it with another gas or combination of gases; or

  3. otherwise controlling the oxygen content to a level below that normally found in the surrounding twenty-one percent (21%) oxygen atmosphere.

  1. A process as specified in subdivision one (1) that involves a food for which Clostridium botulinum is identified as a microbiological hazard in the final packaged form.

  1. The term includes the following:

  1. Vacuum packaging in which air is removed from a package of food and the package is hermetically sealed so that a vacuum remains inside the package, such as sous vide.

  2. Modified atmosphere packaging in which the atmosphere of a package of food is modified so that its composition is different from air but the atmosphere may change over time due to the permeability of the packaging material or the respiration of the food. Modified atmosphere packaging includes any of the following:

  1. Reduction in the proportion of oxygen.

  2. Total replacement of oxygen.

  3. An increase in the proportion of other gases, such as carbon dioxide or nitrogen.

  1. Controlled atmosphere packaging in which the atmosphere of a package of food is modified so that, until the package is opened, its composition is different from air, and continuous control of that atmosphere is maintained as such by using oxygen scavengers or a combination of total replacement of oxygen, nonrespiring food, and impermeable packaging material.

Section 29 "Restricted use pesticide" defined

"Restricted use pesticide" has the same meaning as defined in IC 15-3-3.5-2(27).

Section 30 "Rework" defined

"Rework" means clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food.

Section 31 "Sanitization" defined

"Sanitization" means the application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated for efficacy, is sufficient to yield a reduction of five (5) logs, which is equal to a ninety-nine and nine hundred ninety-nine thousandths percent (99.999%) reduction of representative disease-causing microorganisms of public health significance.

Section 32 "Scheduled process" defined

"Scheduled process" means the process selected by a processor as adequate for use under food manufacturing conditions to achieve and maintain a food that will not permit the growth of microorganisms having a public health significance. The term includes control of pH and other critical factors equivalent to the process established by a competent processing authority.

Section 33 "Water activity" defined

"Water activity" indicated by the symbol aw means water activity that is a measure of the free moisture in a food and the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

Section 34 "Wholesale food establishment" defined

  1. "Wholesale food establishment" means any establishment within the state of Indiana that manufactures, packages, stores, repackages or transports human food products for distribution to another entity for resale or redistribution.

  2. The term does not include the following:

  1. A residential kitchen in a private home.

  2. Bed and breakfast establishments subject to 410 IAC 7-15.5.

  3. An establishment engaged solely in the harvesting, storage, or distribution of one (1) or more raw agricultural commodities, that is not ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the consuming public.

  4. Meat and poultry processing plants subject to IC 15-2.1-24; or dairy processing plants subject to IC 15-2.1-23 and 345 IAC 8 or shell egg plants subject to 370 IAC 1-10-1 and IC 16-42-11.

  5. Any establishments as defined in 410 IAC 7-20-70, except when engaged in activities under subsection (a) of this section or when producing acidified foods in hermetically sealed containers.