FDA Issues Food Safety Modernization Act Preventive Controls Rules

Posted by Rosemary Gordon|September 11, 2015

After more than four years of development, the FDA has released the final Preventive Controls for Human and Animal Food rules, components of the Food Safety Modernization Act (FSMA). The rule emphasizes the importance of hazard analysis and the development of preventive controls to minimize or prevent those hazards from contaminating food. A written food safety plan is required and must be based upon hazard analysis, development of preventive controls, oversight, monitoring, corrective actions and verification.

“Now that the FSMA regulations are being finalized our focus will turn to making sure they are implemented in a way that best serves public health and our industry’s food safety needs,” Produce Marketing Association’s (PMA) Chief Science and Technology Officer Bob Whitaker says. “The preventive controls for human food rules that were published yesterday and others like the produce rule that we expect later this year will have profound business implications across the global produce supply chain.”

Whitaker continued, “We’re thrilled that FDA considered the needs of the industry, specifically when clarifying the definition of ‘farm’ to make it more workable and to reflect the current realities of produce production and handling practices. With this clarification, growers are permitted to pack fresh produce not grown on their farm and remain covered by the FSMA Produce Rule. The ‘farm’ definition also permits produce holding and packing at off-farm locations to be regulated by the Produce Rule.”

Facilities that manufacture, process, or hold foods are responsible for complying with this rule. Specifically, the rule requires the owner, operator, or person in charge of a food facility to implement and track a food safety plan that includes the evaluation of hazards, preventive controls in place to manage those hazards, and the performance of the controls in place.

“The final rules issued today reflect many of the recommendations that PMA and others emphasized in comments, public hearings, and industry meetings over the last few years,” Dr. Jim Gorny, PMA vice president of food safety and technology, says. “In addition to supplying in-depth analysis of these rules and their implications on members’ business in coming weeks, PMA will continue to work closely with allied organizations and Congress to assure that FDA FSMA implementation is realistic and well-supported.