The person-in-charge shall ensure that: All food and food ingredients processed in a food processing plant: Are from an approved source; Are GRAS; If applicable, conform to a standard of identity, as defined in 21 CFR Part 130; Comply with FDA regulations for poisonous or deleterious substances; and Are identified and held in a manner that prevents allergen cross-contact if the food and food ingredients are an allergen or contain an allergen; When ice is used in contact with food, it shall be: Made from potable water; and Manufactured and stored in accordance with this chapter; Compressed air or other gasses mechanically introduced into food do not contaminate the food with unlawful indirect food additives; Raw materials and other ingredients: Are inspected at receipt to ensure that they are acceptable for use; and Are washed or cleaned as necessary to remove soil or other contamination; Food is processed and stored under conditions and control procedures that prevent and protect from: Contamination; and Allergen cross-contact; The potential for contamination and allergen cross-contact is reduced by: Food safety controls; Operating practices; and Separation of operations by: Location; Time; or Effective design; Food is processed and stored at temperatures that: Minimize the potential for the growth of microorganisms; and Prevent adulteration; The thermal processing of food eliminates or reduces the number of pathogens in the food so that the food is safe for human consumption; The cooling of foods is conducted using methods that: Minimize the potential for the growth of microorganisms; and Prevent adulteration; Foods that require temperature control for safety are maintained at the temperature: 38°F or less for foods with a non-proteolytic Clostridium botulinum potential hazard; 40°F or less; 45°F or less for molluscan shellfish or shell eggs; 135°F or higher; or As otherwise approved by the Department; Food that relies principally on the control of aw for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level; 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 4.6 or below; Adequate measures are taken to protect against the inclusion of metal or other extraneous material in food; Frozen food remains frozen when stored or removed from refrigeration in order to be segregated, organized, or moved; Frozen foods are thawed in a manner that prevents contamination; Any food, raw material, or ingredient that is adulterated is not offered to human beings and is: Rejected upon receipt; Treated or processed to eliminate the contamination; Destroyed in a manner that protects against the contamination and allergen cross-contact of other food; Stored only in a designated area that is: Separated from all other food and food process operations; and Conspicuously marked with the intended disposition; Reconditioned using a method that is safe and effective; Reexamined following reconditioning and subsequently found not to be adulterated; Not mixed with another lot of food that is not adulterated; and If detained by the Department: Reconditioned; or Destroyed in a manner approved by the Department; A facility that only stores unexposed packaged foods that require time and temperature control to significantly minimize or prevent pathogens: Establishes and implements temperature controls that significantly minimize or prevent the growth of, or toxin production by, pathogens; Monitors the temperature controls with adequate frequency; Takes appropriate corrective actions if there is a loss of temperature control that may impact the safety of the food; Establishes and maintains affirmative or exception records that document implementation of temperature controls, calibration, or accuracy checks of temperature monitoring and recording devices, and corrective actions; Reviews records of monitoring and corrective actions taken to correct a problem with the control of temperature within: 7 working days after the records are created; or A reasonable time frame; and Reviews records of calibration or accuracy checks within a reasonable time frame after the records are created; Written standard operating procedures are: Available to employees in a format they understand; Implemented; and Reflective of current manufacturing procedures; When the Department requires a scheduled process, the scheduled process is: Established by a process authority; Used to manufacture the target food; Not changed without approval of the process authority; Documented by: Production records; and Process deviation records; and Verified by: Production records review; Equipment calibration; or Laboratory testing; Records that document compliance with this regulation are maintained in accordance with Regulation .06 of this chapter; Human food by-products for use or distribution as animal food without additional manufacturing or processing are: Accurately identified when stored; Stored under conditions that protect against contamination; and Labeled or accompanied by a label identifying the by-product by the common or usual name when distributed; Finished product testing for chemicals, microbes, or extraneous materials is conducted when necessary to identify failures to protect ready to eat food from contamination or allergen cross-contact; and Environmental testing for chemicals or microbes is conducted when necessary to identify failures to protect ready to eat food from contamination or allergen cross-contact.