A. Highlights of the Final Rule

The provisions in the final rule are described briefly in the following paragraphs, and are discussed in more detail later in the preamble of this document.

• Persons who produce shell eggs from a farm operating with 3,000 or more laying hens, unless that farm sells all of its eggs directly to consumers or does not produce shell eggs for the table market, are subject to this final rule (21 CFR 118.1(a)).
• Shell egg producers need only comply with refrigeration and registration requirements if all of their shell eggs from a particular farm receive a treatment as defined in the final rule (§ 118.1(a)(2)).
• Persons who transport or hold shell eggs for shell egg processing or egg products facilities are required to comply with the refrigeration requirements of this final rule (§ 118.1(b)).
• Shell egg producers are required to use the following SE prevention measures:
• Have and implement a written SE prevention plan that includes all mandatory SE prevention measures (21 CFR 118.4);
• Procure pullets that are SEmonitored, or raise pullets under SEmonitored conditions (§ 118.4(a));
• Use a biosecurity program, meaning a program that includes limiting visitors on the farm and in poultry houses; maintaining personnel and equipment practices that will protect against crosscontamination from one poultry house to another; preventing stray poultry, wild birds, cats, and other animals from entering poultry houses; and prohibiting employees from keeping birds at home (§ 118.4(b));
• Use a program to control rodents, flies, and other pests that includes monitoring for pest activity and removing debris and vegetation that may provide harborage for pests (§ 118.4(c)); and
• Clean and disinfect poultry houses before new laying hens are added if an environmental or egg test was positive for SE during the life of the flock; cleaning and disinfecting must include removing all visible manure, dry cleaning to remove dust, feathers, and old feed, and disinfecting (§ 118.4(d)).
• Shell eggs being held or transported are required to be refrigerated at or below 45 degrees Fahrenheit (°F) ambient temperature beginning 36 hours after time of lay (§ 118.4(e)).
• Shell egg producers must conduct environmental testing for SE when laying hens are 40 to 45 weeks of age and 4 to 6 weeks after molt (21 CFR 118.5).
• Shell egg producers must conduct egg testing for SE when an environmental test is positive for SE (21 CFR 118.6).
• Administration of the SE prevention measures requires having one or more supervisory personnel, who do not have to be onsite employees, who are responsible for ensuring compliance with each farm’s SE prevention plan (21 CFR 118.9).
• Shell egg producers must maintain a written SE prevention plan and records documenting compliance with the requirements in the plan (21 CFR 118.10).
• Shell egg producers must retain records for 1 year after the flock to which they pertain has been taken permanently out of production (§ 118.10(c)).
• Shell egg producers must make records available within 24 hours from the time of receipt of the official request (§ 118.10(d)).
• Shell egg producers must register with FDA (21 CFR 118.11).

The compliance date is July 9, 2010; except that, for producers with fewer than 50,000 but at least 3,000 laying hens, the compliance date is July 9, 2012. The compliance date for persons who must comply with only the refrigeration requirements is July 9, 2010.