Core Tasks for Microbial Management of Pet Nutritional Supplements Exported to the United States
To ensure product safety, a risk-based preventive control system must be established and implemented, rather than relying solely on finished product testing.
1. Implement cGMP and Establish a Food Safety Plan
Compliance with 21 CFR Part 507 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food) is mandatory.
1.A written Food Safety Plan must be developed by a qualified individual
2.Conduct a Hazard Analysis to identify biological (e.g., pathogens), chemical, and physical hazards.
3.Establish and implement Preventive Controls (e.g., process controls, sanitation controls, supplier controls) for identified hazards.
4.Conduct monitoring, verification, and corrective actions, and maintain complete records.
2. Establish Key Microbial Control Points and Standards
Salmonella: This is the FDA's mandatory safety red line, with a "zero tolerance" policy. Any product testing positive for Salmonella is considered adulterated and prohibited from entry and sale.
Other Indicator Organisms: While the FDA does not set uniform legal limits for finished products, strict internal quality control standards must be established within the Food Safety Plan, with regular testing. Commonly controlled indicators include:
Escherichia coli (E. Coli). Strictly controlled. Not Detected.
Staphylococcus aureus. Strictly controlled. Not Detected.
Total Yeast & Mold. <100 CFU/g.
Total Aerobic Plate Count. <1000 CFU/g.
Environmental Monitoring: Conduct regular microbial monitoring of the production environment (air, equipment surfaces, etc.) to verify the effectiveness of sanitation control measures.
3. Finished Product Testing and Release
Each batch of product should undergo microbial testing according to internal standards prior to release, and a Certificate of Analysis (COA) should be issued.
Testing items typically include, at a minimum, Salmonella, E. coli, Staphylococcus aureus, Total Plate Count, Yeast and Mold, etc.
