Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation

Description

This document provides guidance to egg producers and other persons who are covered by FDA’s final rule “Prevention ofSalmonellaEnteritidis in Shell Eggs During Production, Storage, and Transportation” (74 FR 33030 (July 9, 2009) (codified at 21 CFR part 118)). The guidance document revises our previous guidance (regarding questions FDA has received on the final rule since its publication) by removing text pertaining to Competitive Exclusion Products, providing citations for regulatory requirements, and making a few editorial changes.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

1

Shell Eggs

Subject to specific exemptions based on hen count or treatment

Stakeholders

4

egg producers

Persons covered by the final rule

owner of broiler breeder flocks

Entities supplying hatching eggs that may be covered by the rule

Shell egg producer

Entity required to comply with refrigeration and prevention measures

Egg producer

Entity responsible for compliance and testing

Regulatory Context

Regulatory Activities

2

Registration

Requirement for facilities to register under section 415 of the FD&C Act

Inspection

FDA verification of qualified facility status, including for-cause inspections

Document Types

3

SE Prevention Plan

Required documentation for SE prevention measures

Investigations Operations Manual

FDA manual defining inspectional approach

Bacteriological Analytical Manual (BAM)

Chapter 5 contains testing methods for egg samples

Attributes

3

compliance date

January 1, 2020 or January 1, 2021 depending on sales volume

45°F ambient temperature

Required refrigeration temperature for holding and transporting eggs

36 hours after time of lay

The timeframe when refrigeration must begin

Technical Details

Substances

1

Salmonella Enteritidis

Pathogen targeted for prevention in shell eggs.; The goal is to prevent SE in shell eggs during production.; National reservoirs in populations of wild birds

Testing Methods

4

Environmental Testing

Testing for SE in the poultry environment

Egg Testing

Testing methodology for SE in shell eggs

Environmental test

Testing for SE in the poultry house environment

Environmental Sampling and detection of Salmonella in Poultry Houses

Specified method for environmental samples

Processes

6

Refrigeration

key control measure to minimize growth

Cleaning and Disinfection

SE prevention measure

Ionizing radiation

Permitted treatment for poultry feed

In-shell pasteurization

A treatment method that achieves at least a 5-log destruction of SE

Equilibration step

Process to bring internal temperature of eggs to room temperature before washing

Treatment

5-log destruction of SE for shell eggs

Identified Hazards

Hazards

2

Rodent infestation

Condition that may render eggs injurious to health

Thermal checks

Hairline cracks in the shell caused by temperature differences during washing

Standards & References

External Standards

2

Egg Products Inspection Act

USDA regulatory authority

AOAC International Official Methods of Analysis

Validation program for alternative methods

Related CFR Sections (11)

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 →
21CFR118.1§ 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 →
21CFR579.40§ 579.40 Ionizing radiation for the treatment of poultry feed and poultry feed ingredients.
Ionizing radiation for the treatment of complete poultry diets and poultry feed ingredients may be safely used as follows:Read full regulation →
21CFR573.460§ 573.460 Formaldehyde.
The food additive formaldehyde may be safely used in the manufacture of animal feeds in accordance with the following conditions: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 →
21CFR118.12§ 118.12 Enforcement and compliance.
(a) Authority. This part is established under authority of the Public Health Service Act (the PHS Act). Under the FFDCA, the Food and Drug Administration (FDA) can enforce the food adulteration provisions under 21 U.S.C. 331 through 334 and 342 . Under the PHS Act ( 42 U.S.C. 264 ), FDA has the authRead full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Failure to conduct environmental testing for SE at 40 to 45 weeks of age

3

Failure to implement a written Salmonella Enteritidis prevention plan

3

Failure to have and implement a written SE Prevention Plan

2

Adulterated shell eggs

2

Eggs held under insanitary conditions

1

Failure to implement a written SE Prevention Plan

1

Failure to conduct environmental testing for SE when laying hens were 40 to 45 weeks

1

Failure to have and implement a written Salmonella Enteritidis prevention plan

1

Failure to register farm as shell egg producer

1

Failure to register as an egg farm

1