Meat, poultry and egg products are regulated by USDA’s Food Safety and Inspection Service (FSIS), not FDA. An FSIS official establishment needs a hazard analysis with a flow chart, a written HACCP plan (9 CFR 417) and Sanitation SOPs with daily records (9 CFR 416). If the plant also processes FDA-regulated foods, FDA rules can apply to that part.
FDA or USDA?
FSIS administers the Federal Meat Inspection Act, the Poultry Products Inspection Act and the Egg Products Inspection Act (9 CFR 300.2). FDA regulates other foods.
A facility regulated exclusively by USDA under those three laws, throughout the entire facility, does not have to register with FDA (21 CFR 1.226(g)). The key word is "exclusively": if the same plant processes FDA-regulated products, that exemption does not apply. FDA’s sanitary transportation rule has an exclusion with the same condition (21 CFR 1.900(b)(3)).
Hazard analysis and HACCP plan (9 CFR 417)
Every official establishment must conduct a hazard analysis that includes a flow chart of each process and identifies the intended use or consumers of the product. It must consider natural toxins, microbiological and chemical contamination, pesticides, drug residues, zoonotic diseases, decomposition, parasites, unapproved additives and physical hazards (9 CFR 417.2(a)).
If hazards are reasonably likely to occur, it needs a written HACCP plan for each product. The rule groups products into nine processing categories, such as slaughter, raw ground, raw not ground, thermally processed commercially sterile, and fully cooked not shelf stable (9 CFR 417.2(b)).
Validation, annual reassessment and training
The establishment must validate that the plan controls the hazards and verify it is being implemented. The plan is reassessed at least annually and whenever changes could affect it, such as raw materials, formulation, methods, volume, personnel or packaging (9 CFR 417.4).
Developing and reassessing the plan is done by someone who completed a course on the seven HACCP principles applied to meat, poultry or egg products, including developing a plan and record review. They need not be an employee of the establishment (9 CFR 417.7).
Sanitation SOPs: documented daily sanitation (9 CFR 416)
Sanitation SOPs describe the daily procedures, before and during operations, to prevent direct contamination or adulteration of product. They are signed and dated by the individual with overall on-site authority when implemented and whenever modified, and they specify the frequency and the employee responsible for each procedure (9 CFR 416.12).
Pre-operational procedures are done before operations start, and implementation is monitored daily (9 CFR 416.13).
Records: how long and where
Sanitation SOP records are daily, initialed and dated by the responsible employee. They may be kept on computers if controls ensure data integrity. They are kept at least 6 months, must stay at the establishment for 48 hours after completion, and may then be kept off-site if they can be provided to FSIS within 24 hours (9 CFR 416.16).
HACCP records are kept at least 1 year for slaughter and refrigerated product, and at least 2 years for frozen, preserved or shelf-stable product (9 CFR 417.5(e)).
Official sources
- 9 CFR 300.2 (FSIS responsibilities)
- 21 CFR 1.226 (who does not have to register)
- 21 CFR 1.900 (sanitary transportation: who is subject)
- 9 CFR 417.2 (hazard analysis and HACCP plan)
- 9 CFR 417.4 (validation, verification, reassessment)
- 9 CFR 417.5 (HACCP records)
- 9 CFR 417.7 (training)
- 9 CFR 416.12 (development of Sanitation SOPs)
- 9 CFR 416.13 (implementation of Sanitation SOPs)
- 9 CFR 416.16 (Sanitation SOP recordkeeping)
Sources verified on November 11, 2026.
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