Authority: IC 16-42-5-5

Affected: IC 16-42-5

Sec. 45. (a) Equipment and utensils and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing and when necessary the following:

1. (1) Equipment shall be taken apart for thorough cleaning and sanitizing.
2. (2) A CIP system may be used when the design of the equipment requires the circulation or flowing by mechanical means through a piping system of a detergent solution, water rinse, and sanitizing solution.

(b) All food manufacturing, including packaging and storage, shall be conducted under conditions and controls as necessary to minimize the potential for the growth of micro-organisms or the contamination of food. Compliance with this subsection may require careful monitoring of physical factors, such as time, temperature, humidity, water activity (aw), 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.

(c) Food that can support the rapid growth of undesirable micro-organisms, particularly those of public health significance, shall be held in a manner that prevents the food from becoming adulterated. Compliance with this subsection shall be accomplished by an effective means, including, but not limited to, the following:

1. (1) Maintaining cold, potentially hazardous foods at forty-one (41) degrees Fahrenheit or below. Exceptions to this requirement are when the receiving and storage temperatures are specified in another law, such as laws governing milk, molluscan shellfish, and shell eggs. These foods may be received and stored at the temperature specified in law.
2. (2) Maintaining hot, potentially hazardous foods at one hundred forty (140) degrees Fahrenheit or above.
3. (3) Heat treating acid or acidified foods to destroy mesophilic micro-organisms when those foods are to be held in hermetically sealed containers at ambient temperatures.

(d) Frozen foods shall be maintained in a frozen state and should be stored at zero (0) degrees Fahrenheit or below. Frozen foods shall not be refrozen after having been thawed unless the products are to be further processed by the processor, as necessary to control microbial growth.

(e) Frozen foods during transportation shall remain frozen and should be at zero (0) degrees Fahrenheit or below. Refrigerated foods during transportation shall be at forty-one (41) degrees Fahrenheit or below unless law governing their distribution applies, such as temperature requirements for shell eggs.

(f) Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH, or controlling aw that is taken to destroy or prevent the growth of undesirable micro-organisms, particularly those of public health significance, shall be effective under the conditions of manufacturing, handling, and distribution to prevent food from being adulterated.

(g) Work-in-process shall be handled in a manner that protects against contamination.

(h) Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, including potential food allergens, or refuse in the following manner:

1. (1) When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in receiving, loading, or shipping areas if that handling could result in contaminated food.
2. (2) Food transported by conveyor shall be protected against contamination as necessary.

(i) Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be of a food grade quality and constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination.

(j) Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food. Compliance with this subsection shall be accomplished by using sieves, traps, magnets, and electronic metal detectors, or other effective means. If lubricants are used on food-contact surfaces, on bearings and gears located on or within food-contact surfaces, or on bearings and gears that are located so that lubricants may leak, drip, or be forced into food or onto food-contact surfaces, they shall meet the requirements specified in 21 CFR 178.3570.

(k) Food, raw materials, and other ingredients that are adulterated shall be disposed of in a manner that protects against the contamination of other food. If the adulterated food is capable of being reconditioned, it shall be reconditioned using a method that has been proven to be effective or it shall be reexamined and found not to be adulterated before being incorporated into other food.

(l) Mechanical manufacturing steps, such as washing, peeling, trimming, cutting, sorting, and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect food against contamination. Compliance with this subsection shall be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food. Protection shall be provided by adequate cleaning and sanitizing of all food-contact surfaces and by using time and temperature controls at and between each manufacturing step.

(m) 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 rapidly cooling the food or passing it to subsequent manufacturing without delays. Thermophilic growth and contamination in blanchers should be minimized by the use of effective operating temperatures and by periodic cleaning. Where the blanched food is washed prior to filling, water used shall be safe and meet the quality standards specified in 327 IAC 8- 2.

(n) Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treated or maintained in such a manner that they are protected against contamination. If the products are potentially hazardous they shall be held at forty-one (41) degrees Fahrenheit or below or at one hundred forty (140) degrees Fahrenheit or above. Compliance with this subsection shall be accomplished by an effective means, including one (1) or more of the following:

1. (1) Using ingredients free of contamination.
2. (2) Employing adequate heat processes where applicable.
3. (3) Using adequate time and temperature controls.
4. (4) Providing effective physical protection of food or equipment from contaminants that may drip, drain, or be drawn into them.
5. (5) Rapid cooling to a storage temperature of forty-one (41) degrees Fahrenheit or below.
6. (6) Disposing of batters at appropriate intervals to protect against the growth of micro-organisms.

(o) Filling, assembling, packaging, and other operations shall be performed in a way that the food is protected against contamination. Compliance with this subsection shall be accomplished by the following:

1. (1) Using a quality control operation in which the critical control points are identified and controlled during manufacturing, if applicable.
2. (2) Adequate cleaning and sanitizing of all food-contact surfaces and food containers.
3. (3) Using materials for food containers and food-packaging materials that are safe and intended for food use.
4. (4) Providing effective physical protection from contamination, particularly airborne contamination.
5. (5) Using sanitary handling procedures.
6. (6) Utilizing adequate control procedures to prevent allergen cross contact.

(p) Food, such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of aw for preventing the growth of undesirable micro-organisms shall be processed to and maintained at a safe moisture level of eighty-five hundredths (0.85) or less. Compliance with this subsection shall be accomplished by any effective means, including the employment of one (1) or more of the following practices:

1. (1) Monitoring the aw of food.
2. (2) Controlling the soluble solids/water ratio in finished food.
3. (3) Protecting finished food from moisture pick-up by use of a moisture barrier or by other means so that the aw of the food does not increase to an unsafe level.

(q) When ice is used as an ingredient or in contact with food, it shall be made from water that is safe and meets the quality standards specified in 327 IAC 8-2. It shall be used only if it has been manufactured in accordance with this rule.

(r) Bottled drinking water, manufactured, used, or sold, shall meet the requirements of 21 CFR 129 and 21 CFR 165.

(s) Food-manufacturing areas and equipment used for manufacturing human food should 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.

(t) The operator of a wholesale food establishment that manufactures ready-to-eat, potentially hazardous foods shall report to the department the results of any microbiological test or other laboratory analysis, which shows a likelihood that any ready-to-eat food produced by that operator contains pathogenic organisms, undeclared allergens, or other health hazards. The operator shall report to the department within twenty-four (24) hours after receiving positive test results. The operator may report orally, electronically, or in writing, except as specified in the following:

1. (1) A wholesale food establishment operator is not required to report test results if the following conditions apply:

   1. (A) A product code or production date identifies the ready-to-eat food lot number.
   2. (B) The wholesale food establishment operator has not sold or distributed any of the food represented by the product code or production lot number as specified under clause (A).
2. (2) The department shall be notified in a timely manner if the wholesale food establishment initiates a recall and if positive testing results in the disposition of products.

(Indiana Department of Health; 410 IAC 7-21-45; filed Jan 7, 2002, 10:16 a.m.: 25 IR 1627, eff one hundred twenty (120) days after filing with secretary of state; errata filed Jan 9, 2002, 12:50 p.m.: 25 IR 1645 ; readopted filed Jul 14, 2008, 2:14 p.m.: 20080806-IR- 410080322RFA; readopted filed Sep 10, 2014, 2:08 p.m.: 20141008-IR-410140299RFA; readopted filed Sep 10, 2020, 2:11 p.m.: 20201007-IR-410200404RFA)