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HHS/FDA

RIN: 0910-AB30

Publication ID: Spring 1998

Title: ●Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration Requirements
Abstract: There have been numerous foodborne outbreaks of Salmonellosis, principally due to Salmonella Enteritidis, that have been traced to the consumption of temperature abused and/or undercooked shell eggs. The Food and Drug Administration has received petitions from Rose Acres Farm, Inc., and the Center for Science in the Public Interest that request, in part, that FDA establish safe handling statements for shell eggs. FDA intends to propose to require safe handling statements on labeling of shell eggs that have not been treated to destroy Salmonella microorganisms that may be present. In accordance with amendments to the Egg Products Inspection Act, USDA proposed on October 27, 1992, to require that shell eggs be stored at an ambient temperature of 7 degrees celcius (45 degrees farenheit). USDA intends to finalize that requirement shortly. However, the USDA rulemaking does not include refrigeration at retail. As part of separate rulemaking, FDA intends to propose regulations, based on recommended provisions of the Retail Food Code, to mandate that shell eggs be stored for retail sale at 5 degrees celsius (41 degrees fahrenheit) or less. FDA is proposing this measure to ensure that shell eggs are handled in a manner to decrease the possible growth of any SE that may be present in shell eggs. All of these actions are intended to reduce the occurrence of illnesses and deaths associated with the consumption of improperly cooked shell eggs.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Prerule Stage
Major: Undetermined	Unfunded Mandates: No
CFR Citation: 21 CFR 101.17(g) 21 CFR 1240.63
Legal Authority: 21 USC 321 42 USC 264

Timetable:

Action	Date	FR Cite
ANPRM	09/00/1998

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: Undetermined
Included in the Regulatory Plan: No
Agency Contact: Geraldine A. June Supervisor, Product Evaluation and Labeling Team Department of Health and Human Services Food and Drug Administration (HFS-822), Center for Food Safety and Applied Nutrition, (HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740 Phone:240 402-1802 Fax:301 436-2636 Email: geraldine.june@fda.hhs.gov