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HHS/FDA RIN: 0910-AF10 Publication ID: Spring 2005 
Title: Quality Standard Regulation Establishing an Allowable Level for Arsenic in Bottled Water 
Abstract: Under section 410 of the Federal Food, Drug, and Cosmetic Act (the Act), not later than 180 days before the effective date of a National Primary Drinking Water Regulation (NPDWR) issued by the Environmental Protection Agency (EPA) for a contaminant under section 1412 of the Safe Drinking Water Act, the Food and Drug Administration (FDA) is required to issue a standard of quality regulation for that contaminant in bottled water or make a finding that such a regulation is not necessary to protect the public health because the contaminant is contained in water in public water systems but not in water used for bottled water. The effective date for any such standard of quality regulation is to be the same as the effective date of the NPDWR. On January 22, 2001, EPA published a final rule revising the existing 0.05 mg/L maximum contaminant level (MCL) for arsenic in public drinking water to 0.01 mg/L (10 ppb). The effective date for this rule was temporarily delayed for 60 days from March 23, 2001, to a new effective date of May 22, 2001, in accordance with the memorandum of January 20, 2001, from the Assistant to the President and Chief of Staff, entitled "Regulatory Review Plan" (66 FR 7701; January 24, 2001). On May 22, 2001, EPA announced that it would further delay the effective date for the rule until February 22, 2002, to allow time to complete a reassessment of the information on which the revised arsenic standard is based. On February 22, 2002, the arsenic MCL of 0.01 mg/L in public drinking water rule became effective and water systems must comply with the new standard for arsenic in public drinking water by January 23, 2006. On March 25, 2003 (68 FR 14501 at 14503), EPA revised the rule text in its January 2001 final rule that established the 10 parts per billion arsenic drinking water standard to express the standard as 0.010 mg/L, in order to clarify the implementation of the original rule. In accordance with section 410 of the Act, FDA is required to issue a standard of quality regulation for arsenic in bottled drinking water by July 27, 2005, with an effective date of January 23, 2006, or make a finding that such a regulation is not necessary to protect the public health. FDA evaluated the MCL for arsenic established by EPA for drinking water and tentatively concluded that, as a standard of quality level for bottled water, it is adequate for the protection of public health. Certain waters used for bottled water may be expected to contain arsenic; thus, FDA believes that adopting EPA's MCL for arsenic will ensure that the quality of bottled water is equivalent to the quality of public drinking water that meets EPA standards. Therefore, on December 2, 2004, FDA proposed an allowable level for arsenic in bottled water of 0.010 mg/L (10 ppb). 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 165.110(b)   
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
Final  Statutory    07/27/2005 
Action Date FR Cite
NPRM  12/02/2004  69 FR 70082   
NPRM Comment Period End  01/31/2005    
Final Rule  07/00/2005    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Henry Kim
Supervisory Interdisciplinary Scientist
Department of Health and Human Services
Food and Drug Administration
HFS-306, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-2023
Fax:301 436-2651

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