The Food and Drug Administration’s (FDA) Final Rule on egg safety, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage and Transportation (21 CFR Parts 16 and 118), requires shell egg producers to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm and further growth during storage and transportation. U.S. egg farmers have and continue to participate in food safety programs like the SE Final Rule in order to protect against food borne illness and provide a safe, high quality product. The rule was first proposed on September 22, 2004 and after several comment periods, went into effect on September 8, 2009. The rule requires egg producers with 50,000 or more birds or persons who store and/or transport eggs to comply with all regulations by July 9, 2010. Egg producers with less than 50,000 birds but more than 3,000 must comply by July 9, 2012.
For proper implementation of the egg safety rule, it is important to understand a few words found throughout the document.
Producer– a person who owns and/or operates a poultry house containing laying hens which produce shell eggs for human consumption.
Poultry house– a building, other structure, or separate section within a structure used to house poultry. For structures comprising more than one section containing poultry, each section
that is separated from the other sections is considered a separate house.
Shell egg (or egg)- the egg of the domesticated chicken.
Farm– all poultry houses and grounds immediately surrounding the poultry houses covered under a single biosecurity program.
Biosecurity– a program including the limiting of visitors on the farm and in poultry houses, maintaining personnel and equipment practices that will protect against cross contamination from one poultry house to another, preventing stray poultry, wild birds, cats, and other animals from entering poultry houses, and not allowing employees to keep birds at home, to ensure that there is no introduction or transfer of Salmonella Enteritidis (SE) onto a farm or among poultry houses.
Flock– all laying hens within one poultry house.
Shell egg processing facility– a facility that processes (e.g., washes, grades, packs) shell eggs for the table egg market.
Egg products facility– a USDA inspected egg products plant where liquid, frozen, and/or dried egg products are produced.
Molting– life stage during which hens stop laying eggs and shed their feathers.
Induced molting– molting that is artificially initiated.
Pest– any objectionable animal including, but not limited to, rodents, flies, and larvae.
Laying cycle– the period of time that a hen begins to produce eggs until it undergoes induced molting or is permanently taken out of production and the period of time that a hen produces eggs between successive induced molting periods or between induced molting and the time that the hen is permanently taken out of production.
The Egg Safety Rule addresses several current on-farm practices that have been proven to reduce the risk of SE entering the laying hen environment. These practices include refrigeration, biosecurity, house cleaning and disinfection, fly and rodent control and SE testing.
Eggs must be refrigerated at an ambient 45° F or less if they will be held, including transport, for 36 hours or more before processing in a shell egg facility or transport to a further processing plant.
How will I determine when the “36-hour clock” for refrigeration starts when it is impossible to determine when each individual egg is laid?
Under § 118.4(e), you must hold and transport eggs at or below 45°F ambient temperature beginning 36 hours after time of lay. FDA considers that the “36-hour clock” for refrigeration begins at the end of the egg collection shift. For example, if you collect eggs from 6:00 a.m. until 5:00 p.m., the “36-hour clock” will begin at 5:00 p.m. on Tuesday for all eggs laid between 5:00 p.m. on Monday and 5:00 p.m. on Tuesday. Thus, those eggs will have to be refrigerated no later than 5:00 a.m. on Thursday.
A successful biosecurity program takes steps to ensure that there is no introduction or transfer of SE into or among poultry houses. Biosecurity measures producers must take include:
Cleaning and disinfection of a poultry house must take place if an environmental test or an egg test was positive for SE at any point during the life of a flock. As part of the cleaning and disinfection procedure, an egg producer must:
Since pests, like flies and rodents, are known to be potentially carriers of SE, it is very important to monitor and control any pests found in and around the poultry house. For a successful pest monitoring program, an egg producer must:
The Egg Safety Rule requires testing of both the poultry house environment as well and the eggs themselves to detect any presence of Salmonella Enteritidis.
An environmental test must be done for each poultry house in accordance at the following flock ages-
Due to the many types of layouts a chicken house can have, each egg producer has a environmental sampling plan unique to his/her farm. These environmental samples are collected and analyzed according to the rule, which provides additional information and guidance on sample preparation. The FDA method for analyzing environmental samples is prescribed in the method entitled ‘ Environmental Sampling and Detection of Salmonella in Poultry Houses,’ April 2008. An equivalent method in accuracy, precision, and sensitivity in detecting SE may also be used.
While eggs have been found to be 90% sterile when laid, bacteria still have the potential to be present in the egg white or yolk. Testing of eggs allows for monitoring of bacteria if they are able to enter the egg. For the Egg Safety Rule, egg testing occurs only if an environmental sample is found to be positive. Four egg tests, each test consisting of over 1,000 eggs, are conducted at two week intervals in order to monitor for SE. The testing methodology used for eggs is found in Chapter 5 of FDA’s Bacteriological Analytical Manual, December 2007 edition. Like the environmental sample analysis, an equivalent method in accuracy, precision, and sensitivity in detecting SE may also be used for egg testing.
If all four egg tests are free of bacteria, there is no more testing of eggs required until the next testing period (if any). If eggs are found positive, an egg producer properly labels, handles and send eggs to be heat-treated, or pasteurized, in order to kill all bacteria that could be in the egg whites and yolks.
A SE Prevention Plan is written and stored at each farm where eggs are produced for human consumption. This plan documents how each farm complies and implements the Egg Safety Rule’s requirements as well as contains all records of all on-farm monitoring reports, modifications to the plan, results from environmental and egg tests, and any corrective actions taken. Each plan is administered and updated by a designated egg company employee.
In order to identify farms for inspection, FDA requires all egg farms to register their location electronically, mail or fax, or by CD-ROM. Egg producers with farms containing 50,000 or more birds must register each farm by July 9, 2010. Egg producers with farms containing less than 50,000 birds but more than 3,000 must register by July 9, 2012.
Egg producers can electronically register their farm by going to http://www.access.fda.gov/oaa/. Registration on this site is available 24 hours a day, 7 days a week beginning May 10, 2010. FDA provides each farm with a registration number.
Mail or Fax
Egg producers can register using FDA Form No. 3733, obtained by writing the US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993 or by requesting the form by phone at 1-888-463-6332. After receiving, each form must be filled out completely and mailed or faxed to the same address or phone number above.
Egg producers may submit their registrations in CD–ROM format using the ISO 9660 (CD–R or CD–RW) data format. These files must be submitted on a PDF rendition of the registration form (see below, FDA Form No. 3733) and be accompanied by one signed copy of the certification statement that appears on the registration form. A CD–ROM may contain registrations for as many facilities as needed up to the CD–ROM’s capacity. CD-ROMs can be mailed to the U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993.
In order to ensure compliance and implementation of the rule, FDA inspectors conduct unannounced inspections at egg farms. Inspection of egg farms began October 2010 for farms containing 50,000+ birds.
FDA inspectors undergo training specific to their area of inspection that includes both classroom time and farm hands-on experiences. They are also provided with an Investigations Operations Manual listing the requirements and authority of an FDA inspector, identification badge, and number. When examining a farm, an inspector provides their credentials (identification like driver’s license and ID number) as well as a Notice of Inspection (FDA Form-482). This official Notice of Inspection gives the FDA the authority to enter and inspect any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held as well as enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in interstate commerce. An example of the notice can be found at http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM127428.pdf.
The Reportable Food Registry (RFR) is an electronic portal for reporting when there is reasonable probability that an article of food or feed will cause serious adverse health consequences. With certain exceptions, FDA does not have authority a recall of food. However, the introduction of adulterated products into commerce is prohibited by the Federal Food, Drug and Cosmetic Act (Section 301 of the FFDCA).
In the case that an adulterated product enters commerce, FDA encourages the responsible party or parties to contact their FDA district office and state or local public health or regulatory officials. Calling the FDA district office and state or local health officials does not relieve the responsible party of the responsibility to submit a report to the RFR. The call to FDA District office and reporting on the RFR has to be done no later than 24 hours after determining that an article of food is a reportable food.
The FDA District Office contact information can be found at- http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129334.htm
Producers can submit a report to or find information on the Reportable Food Registry at