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HHS/FDA RIN: 0910-AF80 Publication ID: Spring 2008 
Title: Beverages: Bottled Water (Completion of a Section 610 Review) 
Abstract: Section 165.110 (21 CFR part 165.110) describes requirements for identity and quality standards for bottled water. FDA is undertaking a review of section 165.110 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in section 165.110 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities.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 the following: (1) The continued need for the regulations in section 165.110; (2) the nature of complaints or comments received concerning the regulations in section 165.110; (3) the complexity of the regulations; (4) the extent to which the regulations in section 165.110 overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in section 165.110. FDA received two comments on these issues and is considering them. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
RFA Section 610 Review: Completion of a Section 610 Review 
CFR Citation: 21 CFR 165.110   
Legal Authority: 21 USC 321    21 USC 341    21 USC 343    21 USC 343-1    21 USC 348    21 USC 349    21 USC 371    21 USC 379e   
Legal Deadline:
Action Source Description Date
Other  Statutory  Planned section 610 review  11/13/2005 
Action Date FR Cite
Begin Review  03/01/2007    
End Review  12/31/2007    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal, Local, State, Tribal 
Federalism: Yes 
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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