February 12, 2025

Compliance Policy Guide (CPG) Sec. 575.100, issued by the Food and Drug Administration (FDA), outlines the enforcement criteria for pesticide residues in food and feed. This guide is crucial for agrochemical manufacturers, as it details how the FDA regulates and enforces permissible levels of pesticide residues to ensure food safety.

Regulatory Basis

The regulation of food and feed containing pesticide residues is governed by sections 402, 408, and 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA). These sections empower the FDA to set tolerances for pesticide residues in food and feed. These tolerances, which are the maximum legal limits of pesticide residues allowed in or on food, are established by both the FDA and the Environmental Protection Agency (EPA). The FDA's tolerance levels are included in Title 21 Code of Federal Regulations (CFR), while the EPA's are in Title 40 CFR.

Key Aspects for Agrochemical Manufacturers

  • Tolerance Levels: Agrochemical manufacturers must be aware of the tolerance levels for their products in various food and feed commodities. Exceeding these levels can lead to enforcement actions.
  • Enforcement Actions: The FDA utilizes CPG Sec. 575.100 as a guide for its internal enforcement processes concerning pesticide chemical residues in food. Violations can result in various actions, including detaining products, issuing warning letters, or pursuing legal action.
  • Monitoring and Sampling: The FDA samples food and feed products to ensure compliance with established tolerances. These sampling plans are risk-based, focusing on chemicals of high public health concern.
  • Coordination with Other Agencies: The FDA collaborates with other agencies such as the EPA and the USDA to create annual sampling plans. This collaboration ensures a comprehensive approach to monitoring and regulating pesticide residues.
  • HACCP: Establishments must identify food safety hazards, including drug residues, environmental contaminants, and pesticides. The regulation also requires establishments to identify preventive measures to control these hazards.

Staying Compliant

To ensure compliance with CPG Sec. 575.100, agrochemical manufacturers should:

  • Conduct thorough testing: Regularly test their products to ensure that residue levels in treated crops remain within established tolerances.
  • Follow Good Agricultural Practices (GAP): Adhere to GAP to minimize pesticide residues in food and feed.
  • Stay informed: Keep abreast of any updates or revisions to CPG Sec. 575.100 and other relevant regulations.
  • Maintain detailed records: Accurate record-keeping can help demonstrate compliance and facilitate traceability in case of any issues.

Conclusion

CPG Sec. 575.100 is a critical document for agrochemical manufacturers, providing essential guidance on the FDA's enforcement criteria for pesticide residues in food and feed. By understanding and adhering to the guidelines outlined in this document, manufacturers can help ensure the safety of the food supply and avoid potential regulatory issues