FSMA’s Preventive Controls Rules Finalized

The FDA has taken one of the most significant steps in decades to prevent foodborne illness by finalizing the first two of seven major rules under the bipartisan FDA Food Safety Modernization Act (FSMA).

The action is the first step in putting greater emphasis on the prevention of foodborne illness, holding imported food to the same food safety standard as domestically produced food, and developing a nationally integrated food safety system in partnership with state and local authorities.

“Today’s announcement sets us on the path to a modern food safety system that will prevent illnesses and continue to build confidence in the safety of the food served to our families every day,” said Dr. Stephen Ostroff, acting FDA commissioner.

The two finalized preventive controls rules focus on implementing modern food manufacturing processes for both human and animal foods to ensure that food companies are taking action and working with the FDA to prevent hazards to customers on the front end, rather than waiting to act until an outbreak has occurred.

The preventive controls rules require human and animal food facilities to develop and implement written food safety plans that indicate the possible problems that could affect the safety of their products and outline steps the facility would take to prevent or significantly minimize the likelihood of those problems occurring. This means that food companies will be accountable for monitoring their facilities and identifying any potential hazards in their products and prevent those hazards. Under these rules, the FDA said it  will be able to assess these systems and their outcomes to prevent problems, will better be able to respond when food safety problems occur, and better protect the safety of manufactured food. 

The preventive controls final rules are the result of an extensive outreach effort, and incorporate thousands of public comments, including valuable input from farmers, consumers, the food industry and academic experts, to create a flexible and targeted approach to ensuring food safety.

“We’ve been working with states, food companies, farmers and consumers to create smart, practical and meaningful rules,” said Michael R. Taylor, deputy commissioner for foods and veterinary medicine, FDA. “And we have made a firm commitment to provide guidance, technical assistance and training to advance a food safety culture that puts prevention first.”

Once the seven FSMA rules are finalized in 2016, they will work together to systematically strengthen the food safety system and better protect public health.

View the rules at:

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals