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HHS/FDA RIN: 0910-AG06 Publication ID: Spring 2008 
Title: ●Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution(Section 610 Review) 
Abstract: Section 101.17 (h) (21 CFR 101.17(h)) describes requirements for the labeling of the cartons of shell eggs that have not been treated to destroy Salmonella microorganisms. Section 115. 50 (21 CFR 115.50) describes requirements for refrigeration of shell eggs held for retail distribution. Section 16.5(a)(4) provides that part 16 does not apply to a hearing on an order for relabeling, diversion, or destruction if shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264) and sections 101.17(h) and 115.50. FDA amended 21 CFR 101.17(h) on August 20, 2007 (72 FR 46375) to permit the safe handling statement to appear on the inside lid of egg cartons to provide the industry greater flexibility in the placement of the statement. FDA is undertaking a review of 21 CFR sections 101.17(h), 115.50, and 16.5(a)(4) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in sections 101.17(h), 115.50 and 16.5(a)(4) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 21 CFR 101.17    21 CFR 115.50    21 CFR 16.5(a)(4)   
Legal Authority: 15 USC 1453    15 USC 1454    15 USC 1455    21 USC 321    21 USC 331    21 USC 342    21 USC 343    21 USC 348    21 USC 371    42 USC 243    42 USC 264    42 USC 271   
Legal Deadline:  None
Action Date FR Cite
Begin Review  12/00/2009    
End Review  12/00/2010    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
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

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