Regulatory Brief

 FSMA Proposed Rule to Establish Current Good Manufacturing Practices for Food for Animals

​Formal Title: [Docket No. FDA-2011-N-0922] Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Food for Animals

Brief Description:

The Food and Drug Administration (FDA) is proposing regulations for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish requirements for current good manufacturing practice in manufacturing, processing, packing, and holding of animal food.  FDA also is proposing regulations to require that certain facilities establish and implement hazard analysis and risk-based preventative controls for food for animals.  FDA is taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventative controls the norm across all sectors of the animal food system.

Excerpt from the AVMA Response:

We understand from docket No. FDA-2011-N-0922 that the FDA is taking actions with the intention of providing greater assurance that animal food is safe and will not cause illness or injury to animals or humans and building an animal food safety system for the future that makes modern science- and risk-based preventive controls the norm across all sectors of the animal food system. Although the proposed rule does not apply to veterinary facilities, the safety and wholesomeness of all products intended for animal consumption are of great importance to the AVMA for reasons of animal health and welfare as well as public health and safety.
The AVMA believes that certain provisions may be overly prescriptive. Focusing on effectiveness of preventive controls may be more beneficial to food safety rather than on specific performance provisions. Furthermore, the AVMA believes that maintaining provisions as nonbinding recommendations rather than requirements would be consistent with a focus on effectiveness rather than performance (eg, use of auxiliary verbs that imply conditional obligations, such as should, rather than verbs that do not allow deviation from the specifications, such as must or shall). The AVMA is aware that manufacturers already use a variety of processes and precautions aimed at delivering safe, wholesome products. Reconciling differences and bridging knowledge and technical gaps should be science based and contribute to the ultimate goal of animal food safety.

Background Documents:

Relevant AVMA Policy: