(a) The owner, operator, or agent in charge of a facility solely engaged in the storage of packaged animal food that is not exposed to the environment must conduct the following activities for any such refrigerated packaged animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin formation by, microorganisms of animal or human health significance:
(1) Establish and implement temperature controls adequate to significantly minimize or prevent the growth of, or toxin formation by, microorganisms of animal or human health significance;
(2) Monitor the temperature controls with sufficient frequency to provide assurance they are consistently performed;
(3) Take appropriate corrective actions if there is a problem with the temperature controls for such refrigerated packaged animal food to:
(i) Correct the problem and reduce the likelihood that the problem will recur;
(ii) Evaluate all affected animal food for safety; and
(iii) Prevent the animal food from entering commerce, if the owner, operator, or agent in charge of the facility cannot ensure the affected animal food is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act;
(4) Verify that temperature controls are consistently implemented by:
(i) Calibrating temperature monitoring and recording devices;
(ii) Reviewing records of calibration within a reasonable time after the records are made; and
(iii) Reviewing records of monitoring and corrective actions taken to correct a problem with the control of temperature within a week after the records are made;
(5) Establish and maintain the following records:
(i) Records documenting the monitoring of temperature controls for any such refrigerated packaged animal food;
(ii) Records of corrective actions taken when there is a problem with the control of temperature for any such refrigerated packaged animal food; and
(iii) Records documenting the verification activities.
(b) The records that a facility must establish and maintain under paragraph (a)(5) of this section are subject to the requirements of subpart F of this part.
SEC 507.50 Requirements applicable to a qualified individual.
(a) One or more qualified individuals must do or oversee the following:
(1) Prepare the food safety plan ( SEC 507.30));
(2) Validate the preventive controls ( SEC 507.45(a));
(3) Conduct a review of records for implementation and effectiveness of preventive controls and appropriateness of corrective actions ( SEC 507.45(c));
(4) Perform a reanalysis of the food safety plan ( SEC 507.45(e)).
(b) To be qualified, an individual must have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum. This individual may be, but is not required to be, an employee of the facility.
(c) All applicable training must be documented in records, including the date of the training, the type of training, and the person(s) trained.
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