Small Entity Compliance Guide: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage

Description

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Scope & Applicability

Regulatory Context

• 21CFR118.1§ 118.1 Persons covered by the requirements in this part.

  (a) If you are a shell egg producer with 3,000 or more laying hens at a particular farm that does not sell all of your eggs directly to consumers and that produces shell eggs for the table market, you are covered by some or all of the requirements in this part, as follows:Read full regulation →

• 21CFR118.4§ 118.4 Salmonella Enteritidis (SE) prevention measures.

  You must follow the SE prevention measures set forth in this section. In addition, you must have and implement a written SE prevention plan that is specific to each farm where you produce eggs and that includes, at a minimum, the following SE prevention measures:Read full regulation →

• 21CFR118.11§ 118.11 Registration requirements for shell egg producers covered by the requirements of this part.

  (a) Shell egg producers covered under § 118.1(a) are required to register their farms with FDA within 30 days of becoming an egg producer or, if already an egg producer, by each farm's applicable compliance date.Read full regulation →

• 21CFR118.3§ 118.3 Definitions.

  The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the FFDCA) ( 21 U.S.C. 321 ) are applicable to such terms when used in this part, except where they are redefined in this part. The following definitions also apply:Read full regulation →

• 21CFR118.5§ 118.5 Environmental testing for Salmonella Enteritidis (SE).

  (a) Environmental testing when laying hens are 40 to 45 weeks of age. As one indicator of the effectiveness of your SE prevention plan, you must perform environmental testing for SE (as described in §§ 118.7 and 118.8 ) in a poultry house when any group of laying hens constituting the flock within tRead full regulation →

• 21CFR118.6§ 118.6 Egg testing for Salmonella Enteritidis (SE).

  (a)Read full regulation →

• 21CFR118.7§ 118.7 Sampling methodology for Salmonella Enteritidis (SE).

  (a) Environmental sampling. An environmental test must be done for each poultry house in accordance with § 118.5 (a) and (b) . Within each poultry house, you must sample the environment using a sampling plan appropriate to the poultry house layout.Read full regulation →

• 21CFR118.8§ 118.8 Testing methodology for Salmonella Enteritidis (SE).

  (a) Testing of environmental samples for SE. Testing to detect SE in environmental samples must be conducted by the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” April 2008, or an equivalent method in accuracy, precision, and sensitivity in detecting SE. TheRead full regulation →

• 21CFR118.9§ 118.9 Administration of the Salmonella Enteritidis (SE) prevention plan.

  You must have one or more supervisory personnel, who do not have to be on-site employees, to be responsible for ensuring compliance with each farm's SE prevention plan. This person must have successfully completed training on SE prevention measures for egg production that is equivalent to that receiRead full regulation →

• 21CFR118.10§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.

  (a) Records: You must maintain the following records documenting your SE prevention measures:Read full regulation →

• PHS Act/Shell Egg Regulation/Adulterated

  North Creek Farm

  2025-12-16

• PHS Act/Shell Egg Regulation/Adulterated

  Robert G. Miller dba Granja Asomante

  2025-11-25

• PHS Act/Shell Egg Regulation/Adulterated

  Nestor Reyes Farm & Associates

  2025-09-30

• PHS Act/Shell Egg Regulation/Adulterated

  Voehlganic Farm LLC

  2025-07-08

• PHS Act/Shell Egg Regulation/Adulterated

  Milo’s Poultry Farms, LLC

  2025-06-03

• PHS Act/Shell Egg Regulation/Adulterated

  Loyd Sanabria Hernandez dba Avicola Santa Fe

  2024-12-24

• PHS Act/Shell Egg Regulation/Adulterated

  Rise N’ Shine Farm, Inc.

  2024-11-26

• PHS Act/Shell Egg Regulation/Adulterated

  Corporacion Avicola Morovis Inc

  2024-07-30

• PHS Act/Shell Egg Regulation/Adulterated

  Zoet Poultry, Inc.

  2024-04-02

• PHS Act/Shell Egg Regulation/Adulterated

  Iowa Egg Company Inc.

  2024-02-13

• Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Status: Final)
• Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Status: Final)
• Small Entity Compliance Guide: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
• CVM GFI #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program (Status: Draft)
• Guidance for Industry: Questions and Answers Regarding the Final Rule on Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House) (Status: Final)
• Small Entity Compliance Guide: Laboratory Accreditation for Analyses of Foods - What You Need to Know (Status: Final)
• Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
• Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)