One of the most significant FSMA-related rules – CGMP and preventive controls for animal feed/pet food – will
require most covered facilities to develop and implement a written food safety plan in which the facility implements
controls to prevent significant hazards from causing feed/pet food products to be adulterated or misbranded.
FSMA requires FDA to establish modified hazard analysis and preventive controls requirements for “qualified
facilities.” In general, as proposed by FDA, a qualified facility would be a very small business – one with less than
$2.5 million in total annual sales of animal feed/pet food.
Within the CGMP and preventive controls rule, FDA has proposed that qualified facilities would need to identify
potential hazards associated with the animal feed/pet food manufactured, processed, packed, or held at the
facility, and demonstrate that identified hazards are being controlled. However, the required level of
recordkeeping and documentation associated with the control of such hazards would not be as extensive as those
required for facilities that do not meet the definition of a qualified facility.
