For the purpose of this part, the following terms are defined:

1. (1) "Acid food or acidified food" means foods that have an equilibrium pH of four and sixth tenths (4.6) or below;
2. (2) "Act" means the Food, Drug, and Cosmetic Act, Acts 1953, No. 415;
3. (3) "Adequate" means that which is needed to accomplish the intended purpose in keeping with good public health practice;

4. (4) "Batter'' means a semifluid substance, usually composed of flour and other ingredients:

   1. (A) Into which principal components of food are dipped or with which they are coated; or
   2. (B) Which may be used directly to form bakery foods;

5. (5) "Blanching", except for tree nuts and peanuts, means a prepackaging heat treatment of food stuffs for a sufficient time and at a sufficient temperature to:

   1. (A) Partially or completely inactivate the naturally occurring enzymes; and
   2. (B) Effect other physical or biochemical changes in the food;
6. (6) "Critical control point" means a point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or filth in the final food or decomposition of the final food;
7. (7) "Department" means the Department of Health and its duly designated representatives;
8. (8) "Food" means any raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption;

9. (9) "Food contact surfaces" means:

   1. (A) Those surfaces of equipment and utensils with which food normally comes in contact; and
   2. (B) Those surfaces from which food may contact drain, drip, or splash back onto surfaces normally in contact with food;
10. (10) “Lot” means the food produced during a period of time indicated by a specific code;

11. (11)

    1. (A) "Microorganism" means yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health significance;

    2. (B) The term "undesirable microorganisms" includes those microorganisms that:

       1. (i) Are of public health significance;
       2. (ii) Subject food to decomposition;
       3. (iii) Indicate that food is contaminated with filth; or
       4. (iv) Otherwise may cause food to be adulterated;

12. (12) "Pest" means any objectionable animal or insect including, but not limited to:

    1. (A) Birds;
    2. (B) Rodents;
    3. (C) Flies; and
    4. (D) Larvae;
13. (13) "Plant" means the building or facility, or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human food;
14. (14) "Quality control measure" means a planned and systematic procedure for taking actions necessary to prevent food from being adulterated;
15. (15) "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;

16. (16)

    1. (A) "Safe moisture level" is a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, storage, and distribution.
    2. (B) The maximum safe moisture level for a food is based on its water activity (a_w).
    3. (C) Water activity will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given a_w will not support the growth of undesirable microorganisms;
17. (17) "Sanitize" means to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing the number of other undesirable microorganisms, but without adversely affecting the product or its safety to the consumer;
18. (18) "Shall" means to state mandatory requirements;
19. (19) "Should" means to state recommended or advisory procedures or identify recommended equipment; and
20. (20) "Water activity'' (a_w) means 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.