* Personnel in animal food facilities such as following good hygiene practices, and protection of food from contamination from personal effects;
* The plant and grounds including proper cleaning, maintenance, and elimination of pests;
* Sanitary operations including maintaining clean and sanitary conditions of food contact surfaces, proper use and storage of toxic cleaning compounds, and exclusion of pests;
* Sanitary facilities and controls such as the plant's water supply, plumbing, and toilet and hand-washing facilities;
* Equipment and utensils including the cleaning and maintenance of such items and protecting animal food from contamination;
* Processes and controls including following adequate sanitation principles, proper labeling of ingredients and finished animal food, ensuring the safety of raw materials, and prevention of contamination of animal food during processing; and
* Warehousing and distribution to protect animal food against contamination and deterioration.
D. Proposed Subpart C--Hazard Analysis and Risk-Based Preventive Controls
1. Written Food Safety Plan
The Agency proposes to require that the owner, operator, or agent in charge of a facility have and implement a written food safety plan that includes as applicable:
* A hazard analysis;
* Preventive controls;
* Monitoring procedures;
* Corrective Action procedures;
* Verification procedures; and
* A recall plan.
2. Written Hazard Analysis
The Agency proposes to require that the written hazard analysis identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are reasonably likely to occur, including biological, chemical, physical, and radiological hazards. The hazard analysis would include an evaluation of the identified hazards to determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur.
3. Written Preventive Controls
The Agency proposes to require that the owner, operator, or agent in charge of a facility identify and implement preventive controls (including at critical control points, if any) to provide assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented and that the animal food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act. The preventive controls would include, as appropriate:
* Parameters associated with the control of the hazard and the maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur;
* Process controls;
* Sanitation controls;
* A recall plan; and
* Any other necessary controls.
4. Written Recall Plan
The Agency proposes to require that the written recall plan be developed for animal food with hazards that are reasonably likely to occur.
The Agency proposes to require the monitoring of the preventive controls to provide assurance that they are consistently performed, including requirements to establish and implement written monitoring procedures and establish and maintain records documenting the implementation of the monitoring procedures.
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