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HHS/FDA RIN: 0910-AC14 Publication ID: Fall 2009 
Title: Prevention of Salmonella Enteritidis in Shell Eggs 
Abstract: Publication of this final rule was an action item in the Food Protection Plan announced by the Department of Health and Human Services (HHS) in November 2007. In July 1999, the Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) committed to developing an action plan to address the presence of Salmonella Enteritidis (SE) in shell eggs and egg products using a farm-to-table approach. FDA and FSIS held a public meeting on August 26, 1999, to obtain stakeholder input on the draft goals, as well as to further develop the objectives and action items for the action plan. The Egg Safety Action Plan was announced on December 11, 1999. The goal of the Action Plan is to reduce egg-related SE illnesses. The Egg Safety Action Plan consists of eight objectives covering all stages of the farm-to-table continuum as well as support functions. On March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July 31, 2000 (Washington, DC), joint public meetings were held by FDA and FSIS to solicit and discuss information related to the implementation of the objectives in the Egg Safety Action Plan. On September 22, 2004, FDA published a proposed rule that would require egg safety measures to prevent the contamination of shell eggs with SE during egg production. The proposal also solicited comment on whether recordkeeping requirements should include a written SE prevention plan and records for compliance with the SE prevention measures, and whether safe egg handling and preparation practices should be mandated for retail establishments that specifically serve a highly susceptible population (e.g., nursing homes, hospitals, day care centers). The proposed egg production SE prevention measures included: (1) Provisions for procurement of chicks and pullets; (2) a biosecurity program; (3) a rodent and pest control program; (4) cleaning and disinfection of poultry houses that have had an environmental or egg test positive for SE; (5) egg testing when an environmental test is positive; and (6) refrigerated storage of eggs held at the farm. Additionally, to verify that the measures have been effective, the rule proposes that producers test the poultry house environment for SE. If the environmental test is positive, eggs from that environment must be tested for SE, and if the egg test is positive, the eggs must be diverted to egg products processing or a treatment process that achieves at least a five-log destruction of SE. The proposed rule was a step in a broader farm-to-table egg safety effort that includes FDA's requirements for safe handling statements on egg cartons, and refrigerated storage of shell eggs at retail, and egg safety education for consumers and retail establishments. The rule had a 90-day comment period, which ended December 21, 2004. To discuss the proposed rule and solicit comments from interested stakeholders, FDA held three public meetings: October 28, 2004, in College Park, MD; November 9, 2004, in Chicago, IL; and November 16, 2004, in Los Angeles, CA. The comment period was reopened until July 25, 2005, to solicit further comment and information on industry practices and programs that prevent SE-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into laying hen houses. On July 9, 2009, FDA published the final rule that requires shell egg producers to implement measures to prevent 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. FDA took 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. The final rule will reduce SE-associated illnesses and deaths by reducing the risk that shell eggs are contaminated with SE. Egg producers with 50,000 or more laying hens have 12 months to comply with the final rule, as do persons who must comply with only the refrigeration requirements. Producers with fewer than 50,000 but at least 3,000 laying hens have 36 months to comply. Producers with fewer than 3,000 laying hens and those who sell all of their eggs directly to consumers are exempt from the rule. FDA is developing guidance documents and will hold public meetings this year to help ensure covered persons understand how to comply with the final rule. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 16    21 CFR 116    21 CFR 118   
Legal Authority: 21 USC 321    21 USC 342    21 USC 371    21 USC 381    21 USC 393    42 USC 243    42 USC 264    42 USC 271    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  09/22/2004  69 FR 56824   
NPRM Comment Period End  12/21/2004    
NPRM Reopened Comment Period End  06/09/2005  70 FR 24490   
NPRM Extension of Reopened Comment Period End  07/25/2005  70 FR 33404   
Final Action  07/09/2009  74 FR 33030   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
John F. Sheehan
Director, Office of Food Safety, Division of Plant and Dairy Food Safety
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition (HFS-315), 5100 Paint Branch Parkway ,
College Park, MD 20740
Phone:240 402-1488
Fax:301 436-2632