1. (a)

   1. (1) All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, processing, and storing of food shall be conducted in accordance with adequate sanitation principles.

   2. (2) Appropriate quality control operations shall be employed to ensure that:

      1. (A) Food is suitable for human consumption; and
      2. (B) Food-packaging materials are safe and suitable.
   3. (3) Overall sanitation of the plant shall be under the supervision of one (1) or more competent individuals assigned responsibility for this function.
   4. (4) All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source.
   5. (5) Chemical, microbial, or extraneous material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination.
   6. (6) All food that has become contaminated to the extent that it is adulterated within the meaning of the Food, Drug, and Cosmetic Act, Acts 1953, No. 415, shall be rejected, or if permissible, treated or processed to eliminate the contamination.

2. (b) Raw materials and other ingredients.

   1. (1)

      1. (A) Raw materials and other ingredients shall be:

3. (i) Inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food; and

   1. (ii) Stored under conditions that will protect against contamination and minimize deterioration.

      1. (B) Raw materials shall be washed or cleaned as necessary to remove soil or other contamination.
      2. (C) Water used for washing, rinsing, or conveying shall be safe and of potable quality.
      3. (D) Water shall not be reused for washing, rinsing, or conveying if it increases the level of contamination of the food.
      4. (E) Containers and carriers of raw materials shall be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.

   2. (2)

      1. (A) Raw materials and other ingredients shall either:

         1. (i) Not contain levels of microorganisms that may produce food poisoning or other disease in humans; or
         2. (ii) Be pasteurized or otherwise be treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the act.
      2. (B) Compliance with this requirement may be verified by any approved means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.

   3. (3)

      1. (A) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins shall comply with applicable United States Food and Drug Administration regulations, guidelines, and defect action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food.
      2. (B) Compliance with this requirement may be verified by any approved means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.

   4. (4)

      1. (A) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material shall comply with applicable United States Food and Drug Administration regulations and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food.
      2. (B) Compliance with this requirement may be verified by any approved means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.

   5. (5)

      1. (A) Raw materials, other ingredients, and rework shall be held:

         1. (i) In bulk, or in containers designed and constructed so as to protect against contamination; and
         2. (ii) At such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated within the meaning of the act.
      2. (B) Material scheduled for rework shall be identified as such.

   6. (6)

      1. (A) Frozen raw materials and other ingredients shall be kept frozen.
      2. (B) If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated within the meaning of the act.

   7. (7) Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination.

      1. (c) Manufacturing operations.

   8. (1)

      1. (A) Equipment and utensils and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary.
      2. (B) Insofar as necessary, equipment shall be taken apart for thorough cleaning.

   9. (2)

      1. (A) All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms or for the contamination of food.
      2. (B) One way to comply with this requirement is careful monitoring of physical factors such as time, temperature, humidity, a_w, pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigeration to ensure that mechanical breakdowns, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of food.

   10. (3)

       1. (A) Food that can support the rapid growth of undesirable microorganisms, particularly those of public health significance, shall be held in a manner that prevents the food from becoming adulterated.

       2. (B) Compliance with this requirement may be accomplished by any effective means, including:

          1. (i) Maintaining refrigerated foods at forty-five degrees Fahrenheit (45° F), (seven and two-tenths degrees Celsius (7.2° C)) or below or as appropriate for the particular food involved;
          2. (ii) Maintaining frozen foods in a frozen state;
          3. (iii) Maintaining hot foods at one hundred forty degrees Fahrenheit (140° F), (sixty degrees Celsius (60° C)) or above; and
          4. (iv) Heat treating acid or acidified foods to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures.
   11. (4) Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH, or controlling a_w that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated within the meaning of the act.
   12. (5) Work-in-process shall be handled in a manner that protects against contamination.

   13. (6)

       1. (A) Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients or refuse.
       2. (B) When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated food.
       3. (C) Food transported by conveyor shall be protected against contamination as necessary.
   14. (7) Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination.

   15. (8)

       1. (A) Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food.

       2. (B) Compliance with this requirement may be accomplished by using:

          1. (i) Sieves;
          2. (ii) Traps;
          3. (iii) Magnets;
          4. (iv) Electronic metal detectors; or
          5. (v) Other suitable effective means.

   16. (9)

       1. (A) Food, raw materials, and other ingredients that are adulterated shall be disposed of in a manner that protects against the contamination of other food.

       2. (B) If the adulterated food is capable of being reconditioned, it shall be:

          1. (i) Reconditioned using a method that has been proven to be effective; or
          2. (ii) Reexamined and found not to be adulterated before being incorporated into other food.

   17. (10)

       1. (A) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting, inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect food against contamination.
       2. (B) Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food.

       3. (C) Protection may be provided by:

          1. (i) Adequate cleaning and sanitizing of all food contact surfaces; and
          2. (ii) Using time and temperature controls at and between each manufacturing step.

   18. (11)

       1. (A) Heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either:

          1. (i) Rapidly cooling the food to forty-five degrees Fahrenheit (45° F) or below; or
          2. (ii) Passing it to subsequent manufacturing without delay.
       2. (B) Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning.
       3. (C) Where the blanched food is washed prior to filling, water shall be safe and of adequate sanitary quality.

   19. (12)

       1. (A) Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treated or maintained in such a manner that they are protected against contamination.

       2. (B) Compliance with this requirement may be accomplished by any effective means, including one (1) or more of the following:

          1. (i) Using ingredients free of contamination;
          2. (ii) Employing adequate heat processes where applicable;
          3. (iii) Using adequate time and temperature controls;
          4. (iv) Providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them;
          5. (v) Cooling to an adequate temperature during manufacturing; and
          6. (vi) Disposing of batters at appropriate intervals to protect against the growth of microorganisms.

   20. (13)

       1. (A) Filling, assembling, packaging, and other operations shall be performed in such a way that the food is protected against contamination.

       2. (B) Compliance with this requirement may be accomplished by any approved means, including:

          1. (i) Use of a quality control operation in which the critical control points are identified and controlled during manufacturing;
          2. (ii) Adequate cleaning and sanitizing of all food-contact surfaces and food containers;
          3. (iii) Using materials for food containers and food-packaging materials that are safe and suitable;
          4. (iv) Providing physical protection from contamination, particularly airborne contamination; and
          5. (v) Using sanitary handling procedures.

   21. (14)

       1. (A) Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of a_w for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level.

       2. (B) Compliance with this requirement may be accomplished by an effective means, including employment of one (1) or more of the following practices as appropriate:

          1. (i) Monitoring the a_w of raw materials, food in process, and finished food;
          2. (ii) Controlling the soluble solids-water ratio in finished food; and
          3. (iii) Protecting finished food from moisture pickup, by use of a moisture barrier or by other means, so that the a_w of the food does not increase to an unsafe level.

   22. (15)

       1. (A) Food such as, but not limited to, acid and acidified food that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of four and sixth tenths (4.6) or below.

       2. (B) Compliance with this requirement may be accomplished by an effective means, including employment of one (1) or more of the following practices as appropriate:

          1. (i) Monitoring the pH of raw materials, food in process, and finished food.
          2. (ii) Controlling the amount of acid or acidified food added to low-fat food.

   23. (16)

       1. (A) When ice is used in contact with food, it shall be made from a water source in compliance with applicable water supply rules adopted by the State Board of Health.
       2. (B) The ice shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part.
       3. (C) Provisions shall be made for drainage of water produced by melting ice.
   24. (17) Food-manufacturing areas and equipment used for manufacturing human food shall not be used to manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food.
   25. (18) Food manufacturing shall not be performed in places of human residence nor shall manufacturing areas open directly into rooms occupied as residence or sleeping quarters.

   26. (19)

       1. (A) Meaningful coding of products sold or otherwise distributed from a manufacturing, processing, packing, or repacking activity shall be utilized to enable positive lot identification to facilitate, where necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use.
       2. (B) Records should be retained for a period of time that exceeds the shelf life of the product, except that they need not be retained more than two (2) years.

Codification Notes: "Aw" means water activity.