What industries are covered by FDA and USDA/FSIS?

FDA covers:

• Food manufacturers and processors (including animal food and food for human consumption)
• Pharmaceutical companies
• Medical device manufacturers
• Cosmetic manufacturers
• Tobacco product manufacturers
• Retailers and distributors handling FDA-regulated goods
• Importers of FDA-regulated products
• Entities engaged in sanitary transportation of human and animal food (FDA FSMA rule, 21 CFR Part 1)
• Food Safety Modernization Act (FSMA) Produce Safety Rule (for farms with >$500,000 produce sales)
• Worker training
• Health & hygiene
• Wildlife/animal intrusion
• Sanitation of tools, equipment, buildings
• Sanitary Transportation of Human and Animal Food Rule (21 CFR Part 1)

USDA/FSIS covers:

• Meat producers
• Poultry producers
• Egg product processors (not shell eggs)
• Facilities handling slaughter, processing, packaging, and labeling of USDA-regulated commodities

USDA (Non-FSIS) covers:

• Organic farms and businesses (USDA National Organic Program (NOP))
• Agricultural commodities and crop programs (not food facility regulation)