FDA Finalizes Animal and Human Preventative Control Rules

September 10, 2015

            On September 10, 2015, the Food and Drug Administration (FDA) posted two long-awaited rules and risk assessments for preventive controls on food. The documents cover human and animal food, which clarify, revisit, and add to specific regulations. The process of creating and finalizing the combined 1,000 page documents took approximately two years and is scheduled to be published on September 17, 2015. Currently, the pre-publication version is available on the Federal Register website.

            The rule for human food is titled, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food”. This rule amends the regulations for human food using two main concepts. First, the FDA aimed to modernize the Current Good Manufacturing Practice (CGMP) requirements that have not been revised since 1986. Secondly, supplementary requirements for domestic and foreign facilities subject to regulation were added to “establish and implement hazard analysis and risk-based preventative controls for food.”  The completed human risk assessment can be found here, in addition to the full human preventative requirements that can be found here.

            Similar to the human food rules, animal food preventative controls looked to establish requirements for the CGMP, while also adding constraints to certain domestic and foreign facilities. In addition, the agency implemented the new statutory provisions that stemmed from the FDA Food Safety Modernization Act (FSMA). This rule, titled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals”, helped to assure that animal food is safe and will not cause illness or injury to humans or animals. The full animal risk assessment can be found here, while the completed animal preventative requirements can be found here.

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