FSMA requires facilities “to identify and evaluate known or reasonably foreseeable hazards that may be
associated with the facility.” Within FDA’s proposed animal feed/pet food rule, the agency defines “hazard” to
mean “a biological, chemical (including radiological), or physical agent that is reasonably likely to cause illness or
injury in humans or animals in the absence of its control.”
Sources of information concerning hazards that facilities likely will need to consider include:
Hazards for which FDA already has established tolerances or action levels;
Hazards associated with recalls and reports submitted to FDA’s Reportable Food Registry; and
Further FDA hazard guidance currently under development.
Within the hazard analysis provisions in the proposed rule, facilities first would be required to identify known or
reasonably foreseeable hazards associated with the facility. Next, facilities would need to narrow identified
hazards to those that a person knowledgeable about the safe manufacturing, processing, packing, or holding of
animal feed/pet food would, based on the outcome of a hazard analysis, establish controls to significantly
minimize or prevent the hazard in animal feed or pet food, as well as components to manage those controls. Such
resulting hazards, if any, would be designated as “significant” and be subject to FDA’s preventive controls
requirements. If, through the hazard analysis, no “significant” hazards are identified, then the facility would have
no further obligations under the preventive controls regulation.
