1. Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation FDA 2000-N-0190

2. Summary of the Proposed Rule The Food and Drug Administration (FDA) is proposing to require shell egg producers to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm. We expect that the requirements that we are proposing in this rule, if finalized as proposed, will result in a significant decrease in the number of SE-contaminated eggs produced on farms. Ultimately, we expect that the proposed requirements in this rule will generate public health benefits through a decrease in the numbers of SE-associated illnesses and deaths caused by consumption of shell eggs.

3. Why is this rule necessary? FDA is taking this action because SE is among the leading bacterial causes of foodborne illness in the United States, and shell eggs are a primary source of human SE infections.

4. Summary of the Final Rule This rule requires shell egg producers to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm and from further growth during storage and transportation, and requires these producers to maintain records concerning their compliance with the rule and to register with FDA.

5. Differences from the Proposed Rule Persons who transport or hold shell eggs for shell egg processing or egg products facilities must comply with the refrigeration requirements. Shell egg producers are required to have and implement written SE prevention plans. The requirements for protective clothing and sanitizing stations have been removed from biosecurity program requirements. The requirement to ``wet clean the positive poultry house'' has been removed. Egg processors are now permitted to equilibrate refrigerated eggs to room temperature just prior to processing.

6. Differences from the Proposed Rule Egg processors are now permitted to equilibrate refrigerated eggs to room temperature just prior to processing. The required time period to perform environmental testing for SE after molting has been changed from 20 weeks to 4 to 6 weeks after molt. Shell egg producers must register with FDA. Shell egg producers must maintain records documenting compliance with each of the SE prevention measures.

7. Changes that affected CFR Sections 21 CFR 118.1 through 21 CFR 118.11 are additions to the CFR that concern this rule. 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)).

8. Changes that affected CFR sections 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 (Sec. 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)

9. Dates Effective Date – September 8, 2009 Enforcement Date – 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

10. Comments Submitted 2,000 submissions in response to initial comment period 20 submissions in response to reopened comment period Raised about 60 major issues By… Trade associates State government agencies Industries Consumer groups

11. Comment 18 This comment objected to wet cleaning in the poultry houses because it is impractical for the northern and colder states states because the wet environment inside will encourage SE growth. Also water could damage equipment and cages. FDA agreed and to dry clean the poultry house to remove dust, feathers, and old feed prior to the addition of new laying hens to the house and following cleaning, to disinfect the positive poultry house with spray, aerosol, fumigation, or another appropriate disinfection method.

12. Comment 23 Because there are so many diverse egg laying facilities such as free-range, cage raised, or pasture raised, the comment suggested there be different sampling methods of manure according the facility type. FDA agreed that same sampling plan may not be practical for all operations and that the sampling plan requirement should be flexible to accommodate variations in housing styles.

13. Comment 30 In section 118.6 (c) sampling protocol stated that if a positive environment is found the eggs must be tested within 24 hours. Due to weekends and holidays this is impractical for laboratories, who won’t be open, to test the samples within that short period. FDA agreed and modified the rule to require that the results of egg testing for the first 1000 eggs must be obtained within 10 calendar days of notification of the positive environmental test. This time period allows for the farm to obtain a laboratory to do the work.

14. Comment 40 Suggested by an agriculture department, states that the FDA should require purchasers of diverted eggs to maintain records indicating that the diverted eggs have been treated. FDA agrees because requiring records and written documents improves precautions and there is less confusion.

15. Comment 14 Under USDA National Organic Program (7 CFR part 205), organic poultry producers must provide outside access for all livestock. This conflicts with sec. 118.4 (b) (4), which requires egg producers to “prevent stray poultry, wild birds & other animals from entering grounds and facilities.” FDA does believe it would be difficult to keep poultry & other animals off the grounds, therefore it will be sufficient to keep strays out of poultry houses. The final rule will be changed so it applies only to poultry houses and not the entire grounds.

16. Comment 16 The proposed rule addressed rodent control, but not fly control. It is recommended that fly control be included and that states should independently decide the number allowed to maintain compliance with the regulation. FDA disagrees that states should individually decide the number of flies in order to maintain compliance. The rule provides minimum national standards in order to prevent SE. The rule also allows flexibility in how the presence is determined, which indicate satisfactory control.

17. Comment 20 Several comments questioned 45 °F as the proposed refrigeration requirement. One such comment stated that moisture would condense on cold eggs & cause them to sweat, increasing the chance of surface contamination penetrating the eggs. Also, when cold eggs are washed, the hot water can cause checks or cracks, decreasing the quality and increasing the risk of surface contamination getting into interior of eggs. The rule is based on research that Salmonellae do not grow well or rapidly at temps less than or equal to 45F. FDA is modifying the rule to allow eggs to reach room temp before being processed. “We believe the benefits of refrigeration accompanied by equilibration outweigh any possible risk associated with sweating of the eggs.”

18. Comment 47 This comment objected to registration requirements as an unnecessary burden & unreasonable invasion of privacy. Believes FDA should only check for compliance. They also believe that unexpected visits are not appropriate. FDA disagrees with this & believes registration will aid in identification of egg producers for inspection & compliance purposes. 21 USC part 374 authorizes FDA inspections with out advance notice, Registration will allow a database to be set up & will be an efficient resource to conduct inspections.