U.S. Department of Agriculture (USDA)

Scope

• Meat, poultry, and egg producers must follow the USDA’s FSIS regulations to ensure their products are safe and correctly labeled.
• Organic farms and businesses involved in organic supply chains must adhere to USDA’s National Organic Program standard.
• Farms with an average of more than $25,000 in annual produce sales must comply with the FDA’s Food Safety Modernization Act (FSMA) Produce Safety Rule. Farms with total food sales of $500,000 or less may qualify for a modified requirement (qualified exemption), depending on how and where the food is sold. This includes standards for worker training, health and hygiene, and domesticated and wild animals, as well as standards to ensure that equipment, tools, and buildings are properly cleaned and maintained to prevent produce contamination.
• Restaurants and retail establishments must use USDA-inspected meat, poultry, and catfish products, but their operations are regulated by state and local health departments, not USDA.

Regulatory citations

Key USDA regulations applicable to meat, poultry, and egg establishments include:

• 7 CFR Subtitle B, Chapter I, Subchapter M, Part 205, National Organic Program. This part outlines the National Organic Program (NOP), which sets standards for the production, handling, and labeling of organic agricultural products.
• 9 CFR Chapter III, Subchapter E, Regulatory Requirements Under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. This subchapter includes various regulations related to the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act, ensuring the safety and quality of meat and poultry products.
  • Part 412, Label Approval. Covers label approval requirements for meat and poultry products.
  • Part 416, Sanitation. Focuses on sanitation requirements in establishments that handle meat and poultry.
  • Part 417, Hazard Analysis and Critical Control Point (HACCP) Systems. Establishes requirements for Hazard Analysis and Critical Control Point (HACCP) systems to ensure food safety.
  • Part 424, Preparation and Processing Operations. Details preparation and processing operations for meat and poultry.
• Recordkeeping requirements are established under the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), and Egg Products Inspection Act (EPIA), and implemented through applicable regulations in 9 CFR Parts 312, 381, 416, and 417.

Key definitions

• Egg Products Inspection Act (EPIA): The USDA FSIS inspects all egg products, with and without added ingredients, with some exceptions. Officially inspected egg products are given the USDA inspection mark.
• Federal Meat Inspection Act (FMIA): All meat sold commercially must be inspected and passed to ensure that it is safe, wholesome, and properly labeled. The USDA FSIS conducts the inspections.
• Food Safety and Inspection Service (FSIS): An agency within the USDA that regulates the safety of meat, poultry, catfish, and egg products (liquid, dried, and frozen) and ensures they’re properly labeled.
• Food Safety Modernization Act (FSMA): Implemented in 2011 to focus on preventing foodborne illness and provide authority to oversee and enforce food supply chains. Enforcement includes preventative controls for human and animal food, food production and growth, global supply chains, vulnerability protection, and sanitary transportation.
• Hazard Analysis and Critical Control Point (HACCP): A management system that addresses food safety through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution, and consumption of the finished product.
• National Organic Program. As part of the USDA, this federal regulatory program develops and enforces consistent national standards for organically produced agricultural products sold in the U.S. It also accredits third-party organizations to certify that farms and businesses meet the standards.
• Poultry Products Inspection Act. The USDA FSIS inspects all poultry products sold in interstate commerce and reinspects imported products to ensure they meet U.S. food safety standards.
• United States Department of Agriculture (USDA). The USDA encompasses 29 agencies ranging from the Farm Service Agency to the Forest Service to Rural Housing Services. Its Food Safety and Inspection Service (FSIS) regulates the safety of meat, poultry, catfish, and egg products and ensures they’re properly labeled.

Summary of requirements

Employers regulated by the USDA must:

• Create and follow sanitation standard operating procedures (SSOPs) to prevent contamination and ensure food safety. USDA requires SSOPs. The USDA, particularly through the Food Safety and Inspection Service (FSIS), mandates that meat, poultry, and egg processing facilities implement sanitation standard operating procedures. These SSOPs are part of the broader regulatory framework that includes requirements for sanitation, safety, and hygiene to protect public health.
• Ensure product labels adhere to USDA labeling requirements.
• Implement HACCP systems to identify and control potential hazards in the production process.
• Train employees in proper hygiene, food safety practices, and sanitation. Depending on their role, some employees may need additional training in areas such as animal handling, pesticide application, or organic certification standards.
• Maintain accurate records, as they apply to HACCP, meat and poultry processing, and egg products.
• Obtain and maintain a grant of inspection from the USDA Food Safety and Inspection Service (FSIS) and operate under continuous USDA inspection, as applicable. USDA facilities that process meat, poultry, and egg products (liquid, dried, and frozen) must be inspected and registered with the USDA's Food Safety and Inspection Service (FSIS). This registration is a part of the inspection process to ensure compliance with food safety standards and regulations.

Note: USDA’s Food Safety and Inspection Service (FSIS) does allow for third-party audits and assessments, especially related to the compliance of meat and poultry facilities. Third-party audits do not replace required USDA inspection. These assessments can be used to verify that establishments are meeting sanitation, safety, and processing standards. However, USDA inspections are still required, and third-party assessments are typically supplementary.