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HHS/FDA RIN: 0910-AF10 Publication ID: Fall 2003 
Title: ●Quality Standard Regulation Establishing 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. 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed 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 
Timetable:
Action Date FR Cite
NPRM  09/00/2004   
NPRM Comment Period End  11/00/2004   
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
Email: hkim@cfsan.fda.gov

 
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