FSMA Final Rule on Preventive Controls for Animal Food

The Preventive Controls for Animal Food rule requires covered facilities to implement a food safety system that includes current Good Manufacturing Practices (cGMPs), a hazard analysis and, if necessary, risk-based preventive controls.

Animal food includes livestock feed as well as pet food, pet treats and food for other animal species like birds and fish.

It is important to note that operations meeting the definition of "farm" are not subject to the preventive controls for animal food rule. An operation devoted to raising animals is not subject to the Preventive Controls for Animal Food rule.

Feed mills that are part of a farm are not subject to the Preventive Controls for Animal Food final rule. However, the FDA intends to publish a proposed rule in the future to implement GMPs established by the Preventive Controls for Animal Food Rule in these mills. 

There are exemptions and modified requirements for animal food businesses that solely engage in holding or transporting raw agricultural commodities and businesses that process nuts or gin cotton. Other types of business may have to follow only certain parts of the regulation depending on their total sales, number of employees, and their distribution channels.

Current Good Manufacturing Practices, provide the basic environmental and operating conditions necessary to support the Food Safety Plan that includes risk based preventive controls. The FDA has finalized GMPs for producing safe animal food that take into consideration the unique aspects of the animal food industry and provide flexibility for the wide diversity in types of animal food facilities.

A facility needs to conduct a hazard analysis by considering all of the possible hazards that could be associated with the materials and production of the food. When a preventive control is required for a hazard, the facility must ensure the effectiveness of the control by having proper:

• Monitoring procedures in order to assure that preventive controls are performed consistently.
• Corrections taken to identify and correct minor problems that may occur during production.
• Corrective actions to identify and correct problems when implementing a preventive control and reduce the likelihood the problem will recur.
• Verification to determine whether a preventive control is operating as intended and to establish the validity of the food safety plan.
• A recall plan able to trace food and ingredients one step forward and one step back.

In addition, some animal food processing facilities will need a supply-chain program to address hazards in raw materials and other ingredients prior to receipt at their facility.

For more information, please visit the Penn State Extension FSMA section.

This program was developed by Food Safety CTS, LLC, for Penn State Extension. Supported by a USDA NIFA Food Safety Outreach Program grant titled "Bilingual Produce Safety Educational Programming for Hispanic/Latino Fresh Produce Growers and Farmworkers in Pennsylvania," USDA NIFA Award number 2017-70020-27236