| Which agency regulates your product (FDA, USDA AMS or USDA FSIS) | USDA's Food Safety and Inspection Service (FSIS) inspects plants that make egg products, "any dried, frozen, or liquid eggs, with or without added ingredients" (9 CFR 590.5); its 2020 rule moved egg substitutes and freeze-dried egg products under FSIS inspection after a three-year phase-in. USDA's Agricultural Marketing Service (AMS) registers and inspects shell egg handlers. FDA regulates shell eggs and most egg foods that aren't egg products, such as hard-cooked eggs and other cooked egg products (590.5). Egg dishes made with meat or poultry, such as a frozen breakfast meal with sausage, can fall under FSIS meat and poultry inspection instead, depending on how much meat or poultry they contain. | Your SQF system follows the rules of whichever agency regulates each product (2.4.1 Food Legislation) |
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| Egg Safety Rule (FDA, 21 CFR Part 118) | Producers with 3,000 or more laying hens at a farm that don't sell all their eggs directly to consumers keep a written Salmonella Enteritidis (SE) prevention plan for each farm: pullets, biosecurity, pest control, cleaning and disinfection, and refrigeration at or below 45°F ambient beginning 36 hours after laying. Each poultry house is tested for SE when its hens are 40 to 45 weeks old; a positive result leads to egg testing or diverting eggs to treatment. Farms register with FDA within 30 days of becoming an egg producer. If every egg from a farm gets a treatment, such as in-shell pasteurization or processing into egg products, only the refrigeration and registration requirements apply. | 2.4.1 Food Legislation; laying farms can certify under the Primary Animal Production code (FSC 1), and egg plants approve egg suppliers under 2.3.4. SQF doesn't replace the Egg Safety Rule or FDA inspection |
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| Refrigeration and carton labeling (FDA, 21 CFR 115.50 and 101.17(h); USDA, 9 CFR 590.50) | Retailers store and display shell eggs at an ambient temperature of 45°F or below, and cartons carry the safe handling statement to "keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly." Eggs processed to destroy all viable Salmonella are exempt from both FDA rules. USDA requires shell eggs packed for consumers to be stored and transported at an ambient 45°F or below with the safe handling statement; producer-packers with 3,000 or fewer layers are exempt from USDA's requirements but still carry FDA's statement. | 11.6.2 Cold Storage, Freezing, and Chilling of Foods; 2.4.7.2 label compliance at product release |
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| Shell Egg Surveillance (USDA AMS, 7 CFR Part 57) | Shell egg handlers who grade and pack eggs for the ultimate consumer register with USDA, except producer-packers with 3,000 hens or less, and packers are inspected at least once each calendar quarter. USDA grading of shell eggs (7 CFR Part 56) is voluntary. | 2.4.1 Food Legislation; SQF doesn't replace USDA surveillance or grading |
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| Egg products inspection (USDA FSIS, 9 CFR Part 590) | Egg products plants operate under continuous FSIS inspection. Pasteurized egg products "must be produced to be edible without additional preparation to achieve food safety" (590.570), unpasteurized egg products can't be released into consumer channels until they're pasteurized or treated (590.415), and official plants must sample and test pasteurized liquid, frozen and dried egg products for Salmonella (590.580). Under FSIS's 2020 rule, Sanitation Standard Operating Procedures (Sanitation SOPs) took effect October 29, 2021 and HACCP plans October 31, 2022. | 2.4.3 Food Safety Plan (pasteurization critical limits); 2.4.4 Product Sampling, Inspection, and Analysis; 2.4.7.3 positive release. SQF doesn't replace FSIS inspection |
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| Food facility registration (FDA, 21 CFR 1.230) | FDA-registered egg facilities renew every other year between October 1 and December 31 of each even-numbered year, including 2026. Farms, and facilities regulated exclusively by USDA throughout the entire facility, don't register (1.226). | SQF certification isn't FDA registration; clause 2.4.1 requires you to comply with the food law that applies to you |
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| Preventive controls for human food (FDA, 21 CFR Part 117) | On-farm shell egg production, and packing by packinghouses that meet FDA's "farm" definition, are exempt from Part 117's current good manufacturing practice (CGMP) and preventive controls requirements (FDA, 80 FR 55908). Other FDA-registered egg facilities, such as off-farm packers or plants making hard-cooked eggs, should confirm which Part 117 subparts apply. | 2.4.3 Food Safety Plan and 2.4.8 Environmental Monitoring |
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| Food Traceability Rule (FDA, 21 CFR Part 1, Subpart S) | Shell eggs, and products (fresh or frozen) that contain raw, unpasteurized eggs, are on FDA's Food Traceability List. Producers with fewer than 3,000 laying hens at a farm are exempt (1.1305(a)(2)), as are shell eggs when all eggs from the farm are treated (1.1305(d)(2)) and food under exclusive USDA jurisdiction (1.1305(g)). Congress directed FDA not to enforce the rule before July 20, 2028. | 2.6 Product Traceability and Crisis Management |
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| Allergen labeling (FDA, 21 U.S.C. 321(qq)) | Egg is one of the major food allergens. FDA's 2025 guidance treats "eggs" as eggs from domesticated chickens, ducks, geese, quail and other fowl. | 2.8.1 Allergen Management, Mandatory; 2.4.7.2 label compliance |
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