U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. Reports, Manuals, & Forms
  4. Reports
  5. Economic Impact Analyses of FDA Regulations
  6. Summary: Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals
  1. Economic Impact Analyses of FDA Regulations

Summary: Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals

This proposed rule would establish regulations for domestic and foreign facilities regarding the manufacturing, processing, packing, or holding of animal food in two ways.  First, it would create new current good manufacturing practice (CGMP) regulations that specifically address the manufacturing, processing, packing, and holding of animal food. Second, it would include new preventive control provisions intended to implement section 103 of the FDA Food Safety Modernization Act (FSMA) for animal food.

In general, with some exceptions the new preventive control provisions would apply to animal food facilities that are required to register with FDA under FDA’s current food facility registration regulations. These preventive controls would include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards. Facilities would also be required to monitor their controls, verify that they were effective, take any appropriate corrective actions, and maintain records documenting these actions.

Preliminary Regulatory Impact Analysis

Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals (PDF - 546KB)

Federal Register: 78 FR 64735, October 29, 2013

Docket: FDA-2011-N-0922

 

   
Back to Top