Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation

Description

The purpose of this document is to provide guidance to egg producers on certain provisions contained in FDA’s July 9, 2009, final rule “Prevention ofSalmonellaEnteritidis in Shell Eggs During Production, Storage, and Transportation” (74 FR 33030), including how to implementSalmonellaEnteritidis (SE) prevention measures, how to sample for SE, and how to maintain records documenting compliance with the final rule.

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

2

egg producers

Persons covered by the final rule

Producer

Entity responsible for implementing biosecurity and pest control; Entity responsible for cleaning, disinfection, and sampling; entity responsible for sampling, testing, and recordkeeping; The entity responsible for providing records within 24 hours of request

Regulatory Context

Document Types

2

SE prevention plan

written plan required to document implementation of prevention measures; Written plan for Salmonella Enteritidis prevention

Temperature logs

records used to document compliance with refrigeration requirements

Attributes

4

SE-positive

Status of a house or flock indicating presence of Salmonella Enteritidis

5-log reduction

required efficacy level for egg treatment/diversion

Width of the house

The following number of swabs should be collected per house, based on the width of the house

24-hour supply of manure

Required condition before sampling shallow pits

Technical Details

Substances

6

Disinfectants

EPA registered substances for cleaning

Manure

Animal excreta used as a soil amendment

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

Citric acid solution

Used at 1870 ppm for sanitation of water lines

Chlorine solution

Used at 20 ppm for sanitation of water lines

70% ethanol

Not effective against viral bloodborne pathogens

Testing Methods

10

Drag-swabbing

Method for sampling the manure pit

Baited Jug-trap

Method for sampling house fly populations

Sticky Card

Device for studying the distribution of adult house fly populations

Rodent Control

Experimental Assessment of Rodent Control on Poultry Farms

Egg testing

testing of 1,000-egg samples following positive environmental test

Environmental testing

initial test to determine if egg testing is required

Drag-swab

This manure row should be sampled with a drag-swab attached to a pole

Hand-swabbing

Alternative sampling method for egg belts and scraper blades

Sampling methodology

sampling methodology for Salmonella Enteritidis (SE) (§ 118.7)

Rodent Indexing

Method to estimate rodent population using live catch traps

Processes

7

Environmental testing

environmental testing for Salmonella Enteritidis (SE) (§ 118.5)

Pasteurization

heating procedure used to effectively eliminate L. monocytogenes; historically established process control for milk

Sanitation

Cleaning and sanitizing procedures for food processing environments; General sanitation program and monitoring recommendations; Sanitation procedures to minimize Listeria contamination; Routine cleaning and sanitizing schedules

Cleaning and Disinfection

SE prevention measure

Dry cleaning

Brushing, scraping, or vacuuming to remove debris without introducing moisture.

Wet washing

Optional cleaning step following dry cleaning

Disinfection

process to reduce microbial load; Process in healthcare facilities to prevent infection transmission.

Identified Hazards

Hazards

5

Salmonella Enteritidis

The primary pathogen (SE) the rule aims to prevent.

SE-positive environmental test

Indicates presence of Salmonella Enteritidis in the facility

cross contamination

protect against cross contamination from one poultry house to another

Cross-contamination

Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces

Rodent Harborage

Debris or vegetation that attracts and shelters pests

Standards & References

Specifications

4

Rodent Index of 1 or less

Acceptance criterion for satisfactory rodent control

1 year

Retention period for records after a flock is out of production

24 hours

the belts should not be operated for 24 hours prior to sampling to ensure fresh manure is sampled; Timeframe for retrieving offsite records for official review

Spot card index of 50 or fewer

Acceptance criterion for satisfactory fly control

Related CFR Sections (6)

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 →
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 →
21CFR118.4§ 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 →
21CFR118.5§ 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 →
21CFR118.8§ 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 →

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