(b) The owner, operator, or agent in charge of a facility must verify that:
(1) Monitoring is conducted as required by SEC 507.39;
(2) Appropriate decisions about corrective actions are being made as required by SEC 507.42;
(3) The preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur; and
(4) The activities conducted must include, as appropriate to the facility and the animal food, calibration of process monitoring and verification instruments.
(c) The owner, operator, or agent in charge of a facility must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur by ensuring that a qualified individual is conducting (or overseeing):
(1) A review of the following records in the timeframe specified:
(i) Monitoring and corrective action records within 1 week after the records are made; and
(ii) Records of calibration of instruments within a reasonable time after the records are created.
(2) A review of the records in paragraphs (c)(1)(i) and (c)(1)(ii) of this section to ensure:
(i) The records are complete;
(ii) The activities reflected in the records occurred in accordance with the food safety plan;
(iii) The preventive controls are effective; and
(iv) Appropriate decisions were made about corrective actions.
(d) The owner, operator, or agent in charge of a facility must establish and implement written procedures, as appropriate to the facility and the animal food, for the frequency of calibrating process monitoring and verification instruments.
(e) The owner, operator, or agent in charge of a facility must:
(1) Conduct a reanalysis of the food safety plan:
(i) At least once every 3 years;
(ii) Whenever a significant change is made in the activities conducted at the facility operated by such owner, operator, or agent in charge if the change creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard;
(iii) Whenever the owner, operator, or agent in charge becomes aware of new information about potential hazards associated with the animal food;
(iv) Whenever a preventive control is not properly implemented and a specific corrective action procedure has not been established;
(v) Whenever a preventive control is found to be ineffective; and
(vi) Whenever FDA requires a reanalysis in response to newly identified hazards and developments in scientific understanding.
(2) Complete the reanalysis and implement any additional preventive controls needed to address the hazard identified before the change in activities at the facility is operative or, when necessary, during the first 6 weeks of production;
(3) Revise the written food safety plan if a significant change is made, or document the basis for the conclusion that no additional or revised preventive controls are needed; and
(4) Ensure the reanalysis is performed (or overseen) by a qualified individual.
(f) All verification activities taken in accordance with this section must be documented in records.
SEC 507.48 Modified requirements that apply to a facility solely engaged in the storage of packaged animal food that is not exposed to the environment.
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