The Alliance consists of members from the U.S. Food and Drug Administration (FDA) and state regulatory agencies, industry, academia and scientific organizations, and is charged with developing training and guidance materials to effectively implement regulations being promulgated by FDA under the Food Safety Modernization Act (FSMA).
Fairfield will lead the Alliance's efforts, the bulk of which will begin after FDA publishes for stakeholder comment new and revised provisions within its proposed rule for current good manufacturing practice and preventive controls for animal feed and pet food. The revisions currently are undergoing White House Office of Management and Budget review. It is anticipated that the proposed rule will be published in August or September.
Training/Guidance Materials: The Alliance will develop materials for a standardized hazard analysis and preventive controls training program for the animal feed and pet food industries, as well as associated regulatory personnel. Topics to be addressed within the training program include:
• Using prerequisite programs, such as good manufacturing practices and sanitation programs;
• Conducting a hazard analysis;
• Determining appropriate preventive controls and accessing their effectiveness; and
• Establishing and maintaining records.
The Alliance also will develop materials for use by firms when conducting a hazard analysis that provide guidance on the risk that various hazards may pose in animal feed and pet food products.
The training and guidance materials developed by the Alliance will play a major role in determining how FDA's final requirements will be interpreted and applied by inspectors for compliance purposes. The Alliance's goal is to have the materials completed and ready for use shortly after FDA issues its final hazard analysis and preventive control regulations, which is mandated by court order to occur no later than Aug. 30, 2015.