Within FDA’s proposed CGMP and preventive controls rule for animal feed/pet food, the agency states, “FDA
tentatively concludes for several reasons that HACCP is the appropriate framework to reference in interpreting
and implementing section 103 [hazard analysis and preventive controls] of FSMA.” However, one distinction that
FDA has proposed to make between its hazard analysis and preventive controls requirements and HACCP is that
covered facilities would not need to perform and document the five preliminary steps typically associated with
developing and implementing a HACCP plan.
Significantly, and as addressed in question 7, if a facility conducts the required hazard analysis and identifies no
“significant” hazards, then the use of preventive controls, along with associated management activities, would not
be required under the regulation. However, if a facility does identify a “significant” hazard within its operation, then
the facility would need to implement preventive controls in accordance with the regulation, which consists of the
use of HACCP-like principles.
