U. S. Food and Drug Administration
U. S. Department of Agriculture
July 31, 2000

Public Meeting on Eggs

"Current Thinking Papers on National Standards for Egg Safety"

Holiday Inn on the Hill
New Jersey Avenue, NW
Washington, DC
July 31, 2000

FOOD AND DRUG ADMINISTRATION
ON-FARM STANDARDS FOR REDUCING SALMONELLA ENTERITIDIS IN SHELL EGGS

The President's Council on Food Safety has identified egg safety as one component of the nation's food safety program that warrants immediate federal, interagency action. The Council developed an Egg Safety Action Plan to address the presence of Salmonella Enteritidis (SE) in shell eggs and egg products using a farm-to-table approach. The Action Plan offers industry the flexibility to choose from two SE reduction strategies, each equivalent to meet the Action Plan's interim goal of a 50% reduction in egg-associated SE illnesses by 2005. Risk reduction in Strategy I is based on measures designed to reduce SE contamination of eggs during production, while risk reduction in Strategy II is based on measures designed to eliminate SE from contaminated eggs at the processor. In addition, the Action Plan has retail and education objectives to reduce the risk of SE illnesses. Proposed rules for egg safety standards are scheduled to be published in 2000, followed by publication of final rules in 2001 and implementation of the standards in 2002-2003. The proposed rules will be informed by estimates of the benefits and costs of regulatory options. FDA expects its proposed rule to be economically significant.

On March 30, 2000, and April 6, 2000, FDA and FSIS held public meetings in Columbus, OH, and Sacramento, CA, respectively, to solicit and discuss information related to the implementation of the Egg Safety Action Plan and to gather information for reducing or eliminating the risk of SE in eggs. In an effort to expand the public process and build upon the two public meetings, FDA and FSIS are sharing their current thinking on the integral features of the farm-to-table egg safety standards to reduce egg-associated SE illnesses. Draft current thinking documents (on-farm, packer/processor, and retail) are available for your review, public discussion and comment at a public meeting July 31, 2000, at the Holiday Inn on the Hill in Washington, D.C. These documents represent current thinking and are not the agencies' final position. The agencies are sharing these current thinking documents with the public to receive input from interested stakeholders.

• Producers (other than those who sell all of their eggs directly to consumers (e.g., roadside stand operators)) who provide eggs for the table egg market must comply with all requirements (Strategy I).
• Producers whose eggs will be treated to destroy SE must comply only with the refrigeration requirement below (Strategy II).
• All producers who sell eggs must register with FDA.

Components may include:

• Use of chicks and pullets from SE-monitored breeder flocks
• Biosecurity
• Rodent and pest control program
• Cleaning and disinfection of poultry house, if house or eggs are SE-positive
• Use of Salmonella-negative feed
• Refrigerated storage of eggs held for more than 36 hrs after laying

Environmental Testing:	40-45 weeks of age + 25 weeks after end of each molting period (i.e., same time period as initial environmental test)
	Negative Positive   Egg Testing   Negative Positive     Diversion

Administration of the SE Risk Reduction Plan

One individual at each production facility must successfully complete training on SE risk reduction measures for egg production. That individual is responsible for administering the SE risk reduction plan.

Producers will maintain a written SE risk reduction plan and records indicating compliance with all components of the plan.

FSIS's overall approach to regulating shell egg packers and processed egg product plants is to eliminate, modify, and add requirements to the egg and egg products inspection regulations that will make the regulations consistent with the Agency’s regulatory approach to meat and poultry products under 9 CFR Part 416, Sanitation, and Part 417, HACCP. An economic analysis is being developed around the options under consideration and the feasibility of implementing these requirements will be examined as part of the analysis.

• All shell egg packers
• All egg products processors

• All shell egg handlers except for producer-packers with an annual egg production from a flock of 3,000 or less who grade and pack eggs for the ultimate consumer, persons who must register with the Food and Drug Administration, and hatcheries

• Any shell egg producer-packer with an annual egg production from a flock of 3,000 or fewer hens who also does not pack eggs for other producers

Exemptions from the temperature and labeling requirements

Raw eggs:

• Have been transported at an ambient temperature of 7 ° C (45 ° F) or below; and
• Are clean and sound; and
• Do not contain more restricted eggs than allowed in U.S. Consumer Grade B.

• Liquid, frozen, and dried egg products are in pasteurized form.

Substitute treated eggs or pasteurized egg products for raw eggs in food items that:

• Contain raw egg ingredients and are not subsequently thoroughly cooked; or
• Are prepared by combining and holding eggs prior to service; or
• Are prepared by holding eggs following cooking prior to service.

• Options for serving ready-to-eat foods prepared with raw or undercooked eggs.
• Times and temperatures for cooling and holding foods containing raw or undercooked eggs that are not thoroughly cooked.

Hypertext updated by ear 2000-AUG-04