Section 410IAC7-21-44. Raw materials; production and process controls

   (a) All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with current sanitation principles as follows:

(1) Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable.

(2) Overall sanitation of the plant shall be under the supervision of one (1) or more competent individuals assigned responsibility for this function.

(3) All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source by adhering to the following:

(A) Chemical, microbial, or extraneous material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination.

(B) All food that has become contaminated to the extent that it is adulterated shall be rejected or, if permissible, treated or processed to eliminate the contamination.

  (b) Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ensure that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration by the following:

(1) Washing or cleaning raw materials as necessary to remove soil or other contamination.

(2) Using water for washing, rinsing, or conveying food that is safe and meets the quality standards specified in 327 IAC 8-2.

(3) Reusing water for washing, rinsing, or conveying food if it does not increase the level of contamination of the food.

(4) Inspecting on receipt containers and carriers of raw materials to ensure that their condition has not contributed to the contamination or deterioration of food.

  (c) Raw materials and other ingredients shall not contain levels of micro-organisms that may produce foodborne illness or other disease in humans. If the potential for high levels of disease-causing micro-organisms is present, food shall be pasteurized or otherwise treated during manufacturing operations so that the food no longer contains levels that would cause the product to be adulterated. Compliance with this requirement may be verified by any effective means, such as with a HACCP plan or purchasing raw materials and other ingredients under a supplier's guarantee or certification.

  (d) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins shall comply with current state and federal regulations, guidelines, and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. Compliance with this requirement may be accomplished by:

(1) purchasing raw materials and other ingredients under a supplier's guarantee or certification; or

(2) verifying by analyzing these materials and ingredients for aflatoxins and other natural toxins.

  (e) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable micro-organisms, or extraneous material shall comply with applicable state and federal regulations, guidelines, and defect action levels for natural or unavoidable defects, as specified in 21 CFR 110.110, if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be verified by any effective means, such as:

(1) purchasing the materials under a supplier's guarantee or certification; or

(2) examination of these materials for contamination.

  (f) Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed to protect against contamination and shall be held at proper temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated. Material scheduled for rework shall be identified as such.

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

  (h) Frozen raw materials and other ingredients shall be kept frozen. 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.

  (i) Food may not contain unapproved food additives or additives that exceed amounts specified in 21 CFR 170 through 21 CFR 180 relating to food additives generally recognized as safe, or prior sanctioned substances that exceed amounts specified in 21 CFR 181, 21 CFR 182, 21 CFR 184, and 21 CFR 186. (Indiana State Department of Health; 410 IAC 7-21-44; filed Jan 7, 2002, 10:16 a.m.: 25 IR 1626, eff one hundred twenty (120) days after filing with secretary of state; readopted filed Jul 14, 2008, 2:14 p.m.: 20080806-IR-410080322RFA; readopted filed Sep 10, 2014, 2:08 p.m.: 20141008-IR-410140299RFA)