Fact Sheet on FDA'S Proposed Regulation: Prevention of Salmonella Enteritidis in Shell Eggs During Production

September 20, 2004

FDA is proposing measures to prevent Salmonella Enteritidis (SE) contamination of shell eggs during egg production. The motivation for this proposal is a farm-to-table risk assessment of SE in eggs which identified implementation of on-farm prevention measures as a very important step that could reduce the occurrence of SE infections from eggs. While voluntary quality assurance (QA) programs for egg production have led to meaningful reductions in SE illnesses, these programs are not always uniformly administered or uniformly comprehensive in their prevention measures.

Moreover, the most recent data from the Centers for Disease Control and Prevention (CDC) show that SE illnesses have essentially remained steady for the past several years. CDC estimated that 118,000 illnesses were caused by consumption of SE-contaminated eggs in 2001. Accordingly, FDA believes that further actions to improve egg safety--building upon the safe consumer handling labeling and egg refrigeration at retail rule of 2000--are the most effective way to achieve our public health goals of a 50% reduction in overall salmonellosis and a 50% reduction in SE outbreaks by 2010.

What is FDA Proposing? The proposed rule's SE prevention measures include:

• Provisions for procurement of chicks and pullets
• A biosecurity program
• A pest and rodent control program
• Cleaning and disinfection of poultry houses that have had an environmental sample or egg test positive for SE before new laying hens are added to the house
• Refrigerated storage of eggs at the farm
• Producer testing of the environment for SE in poultry houses--if the environmental test is positive, FDA proposes that egg testing for SE be undertaken, and that, if an egg test is positive, the eggs be diverted from the table egg market
• Identification of a person responsible for SE prevention at each farm
• Recordkeeping requirements for environmental and egg sampling and testing and for egg diversion
• Exemptions: the proposed rule would not apply to producers who sell all of their eggs directly to consumers or producers with fewer than 3,000 laying hens. In addition, if a producer has 3,000 or more laying hens and all eggs at a farm are to be given a treatment that will achieve at least a 5-log destruction of SE or processed into egg products, then only the proposed refrigeration requirements would apply.

Procurement of Chicks and Pullets: Chicks and pullets that came as chicks from breeder flocks would have to meet USDA's National Poultry Improvement Program's standards for "U.S. S. Enteritidis Monitored" status or equivalent standards. The fact that SE can be transmitted via the transovarian route means that chicks can be born SE-positive. They may remain infected as pullets, be placed into poultry houses as layers already carrying SE and then contaminate their eggs and, in addition, pass SE on to other layers within the poultry house.

Biosecurity Program: A program would have to be instituted to prevent SE from being transferred from the environment into the poultry house or among poultry houses. Biosecurity is a routine part of all existing egg QA programs and is aimed at preventing the horizontal spread of SE. An effective biosecurity program must cover the grounds and all facilities, including poultry houses, for each egg farm in order to prevent cross-contamination among poultry houses and contamination of poultry houses from the environment. This includes, where practical, purchasing separate equipment for each poultry house within a farm because shared equipment can cause SE cross-contamination between poultry houses. Where separate equipment is not practical (e.g., manure removing equipment or egg belts), the proposed rule would require keeping such pieces of equipment clean and ensuring that they are not sources of SE contamination that can be spread from one house to another.

Pest and Rodent Control Program: A program would have to be developed and implemented to control rodents, flies and other pests. Both rodents and flies have been shown to harbor SE within the poultry house environment. While baiting and trapping are possible methods to reduce a rodent population, producers should choose a method that will be effective in their individual houses. If rodenticides are used, care must be taken to prevent chickens or other nonrodents from consuming the bait. Flies and other pests would be monitored through spot cards, Scudder grills, sticky traps or another appropriate method that indicates pest activity. Debris within a poultry house and vegetation and debris outside of a poultry house that may harbor rodents and pests would have to be removed, and, where possible, poultry houses would have to be sealed against entrance by rodents and pests.

Cleaning and Disinfection of Poultry Houses: Once a poultry house has had an SE-positive environmental or egg test, in order to prevent the SE problem from being perpetuated in the replacement flock, measures would have to be taken to rid the environment of SE before new laying hens are placed into that house. Procedures for cleaning and disinfection of a poultry house would include removal of visible manure, dry cleaning, followed by wet cleaning using disinfectants, and finally, disinfecting.

Refrigerated Storage of Eggs at the Farm: Eggs would have to be stored at or below 45°F (7.2°C) ambient temperature if held at the farm for more than 36 hours after laying. This proposed requirement is the only SE prevention measure in this proposed regulation that applies to all producers with 3000 or more laying hens, regardless of whether their eggs will be treated to achieve a 5-log destruction of SE or processed into egg products.

Producer Testing for SE in Poultry Houses: Shell egg producers would have to conduct environmental testing for SE as an indicator of whether SE prevention measures are working effectively, if:

• They have 3,000 or more laying hens that produce shell eggs for the table market,
• They do not sell all their eggs directly to consumers, and,
• Any of their eggs that are produced at a particular farm do not receive a treatment that achieves at least a 5-log destruction of SE or are processed into egg products.

Identification of a Person Responsible for SE Prevention: One individual at each farm would be responsible for administration of SE prevention measures. Because egg production operations tend to be small and may have frequent turnover in staff, it is particularly important that one individual have training equivalent to a standardized curriculum recognized by FDA or be otherwise qualified through job experience to administer the SE prevention measures.

Recordkeeping Requirements: Shell egg producers would have to keep records indicating compliance with environmental and egg sampling requirements and the results of the testing performed and, when applicable, must also keep records indicating compliance with the egg diversion requirements, if:

• They have 3,000 or more laying hens that produce shell eggs for the table market,
• They do not sell all their eggs directly to consumers, and,
• Any of their eggs that are produced at a particular farm do not receive a treatment that achieves at least a 5-log destruction of SE or are processed into egg products.

These records may be handwritten logs, invoices, documents reporting laboratory results, or other appropriate records.

Costs and Benefits of Proposed Regulation: The regulation as proposed will have an expected annual cost of $82 million and prevent an expected 33,450 illnesses due to SE annually, at a cost of $2,450 per illness prevented. The proposed regulation will provide expected total annual benefits of $580 million resulting in $498 million in net benefits annually.

How to Comment on Proposed Regulations: Under U.S. law, proposed regulations are published in the Federal Register to provide interested parties with an opportunity to submit comments, e.g., suggestions to make the proposal more effective or less burdensome, questions regarding the agency's data or assumptions, submission of information the agency may not have, etc. FDA will consider all timely comments that it receives as it develops the final egg safety rule which will be published in the Federal Register. Regularly updated information on this regulatory proposal and how to comment on it can be accessed electronically at http://www.fda.gov/dockets/ecomments.

Comments on this proposed regulation, Prevention of Salmonella Enteritidis in Shell Eggs during Production, (Docket Numbers 1996P-0418, 1997P-0197, 1998P-0203, and 2000N-0504 and RIN Number 0910-AC14), will be accepted until December 21, 2004. Comments may be submitted by any of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
• Agency Web Site: http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site.
• E-mail: fdadockets@oc.fda.gov. Include [Docket Nos. 1996P-0418, 1997P-0197, 1998P-0203, and 2000N-0504 and RIN Number 0910-AC14] in the subject line of your e-mail message.
• FAX: 301-827-6870.
• Mail/Hand Delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.