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)

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, codified at 21 CFR part 118), that reference the “poultry house.” Specifically, this document provides guidance to shell egg producers whose production systems provide laying hens with access to areas outside of a “poultry house” as that term is defined in 21 CFR 118.3.

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

The primary audience for this guidance document.

Shell Egg Producer

Entity subject to the egg rule if they have 3,000 or more laying hens.

Regulatory Context

Regulatory Activities

1

Environmental Sampling

Requirement to sample the poultry house environment using a sampling plan.

Attributes

2

Outdoor access

Terminology used in NOP, changed to 'access to areas outside the poultry house' in this guidance.

Rodent Index

A measurement (RI) used to indicate satisfactory rodent control.

Technical Details

Substances

4

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

Campylobacter

Role of rodents in transmission

Salmonella spp.

Pathogen subject to hazard analysis; Known hazard that can become established in dry food production environments.; Pathogen of concern in dried foods; Pathogen discussed in multiple references regarding contamination

Insecticides

Insecticides should not be used as a substitute for good management and sanitation.

Testing Methods

10

Visual Inspection

Method for monitoring rodent activity.

Relative abundance techniques

Monitoring rodent populations

Chew Cards

Also known as bait cards, used to monitor rodent levels.

Spot Cards

Method for monitoring fly activity.

Scudder Grills

Method for monitoring fly concentrations.

Spot Card Method

A spot card index of 50 or fewer per card indicates satisfactory fly control.

Fixed Sticky Tape Method

A weekly count of 50 or fewer flies per tape.

Moving Sticky Tape Method

A count of 75 or fewer flies per tape.

Scudder Grill

A count of less than 20 on a Scudder grill.

Baited Traps

A fly count of 250 or fewer flies per week.

Processes

1

Cleaning and disinfection

You must clean and disinfect the poultry house before new laying hens are added.

Identified Hazards

Hazards

8

Salmonella Enteritidis

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

Housefly

Musca domestica L. as a carrier of Salmonella

Litter beetles

Potential reservoir for Salmonella enterica

Pest harborage

Vegetation and debris that may provide harborage for pests.

Predation

A factor considered when defining a poultry house structure.

Wild Birds

Common vectors of SE.; National reservoirs of Salmonella Enteritidis

Rodents

Known vectors of SE that must be monitored and controlled.; Role in transmission of Salmonella and Campylobacter

Flies

Known vectors of SE that must be monitored and controlled.

Standards & References

External Standards

1

Terrestrial animal health code, chapter 6.4

Biosecurity procedures in poultry production by OIE

Related CFR Sections (4)

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 →
21CFR118.7§ 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 →

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