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Guidance for Industry: Bottled Water: Uranium; Small Entity Compliance Guide

Contains Nonbinding Recommendations

April 2009

Small Entity Compliance Guide

 

You may submit written or electronic comments regarding this guidance at any time. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
 

Additional copies are available from:
Office of Food Safety
Division of Plant and Dairy Food Safety (HFS-317)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-1700 (Updated phone: 240-402-1640)
http://www.cfsan.fda.gov/guidance.html

 

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
April 2009


Contains Nonbinding Recommendations

Table of Contents


Contains Nonbinding Recommendations

Guidance for Industry(1)
Bottled Water: Uranium
Small Entity Compliance Guide

 

 

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.


 

I. INTRODUCTION

On March 3, 2003, FDA published a direct final rule that amended its bottled water quality standard by establishing an allowable level for the contaminant uranium. As a consequence, bottled water manufacturers are required to monitor their finished bottled water products for uranium at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water (21 CFR part 129). Bottled water manufacturers are also required to monitor their source water for uranium as often as necessary, but at least once every four years unless they meet the criteria for the source water monitoring exemptions under the CGMP regulations. FDA retained the existing allowable levels for combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity(68 FR 9873) and listed analytical methods used for determining compliance with the quality standard for radionuclides in bottled water (68 FR 9873 at 9874). On June 9, 2003, FDA confirmed the effective date of December 8, 2003 for the direct final rule (68 FR 34272).

FFDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the legal requirements of the March 3, 2003 direct final rule set forth in 21 CFR part 165 concerning the contaminant uranium. These regulations are binding and have the full force and effect of law.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

 

II. BACKGROUND

Under section 410(b)(1) of the Federal Food, Drug, and Cosmetic Act, not later than 180 days before the effective date of a National Primary Drinking Water Regulation issued by the Environmental Protection Agency (EPA) for a contaminant under section 1412 of the Safe Drinking Water Act, 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 drinking water.

In the Federal Register of December 7, 2000 (65 FR 76708), EPA published a final rule establishing a maximum contaminant level (MCL) for uranium in public drinking water and retained the existing MCLs for combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity. EPA took this action, in part, because studies have shown that long-term exposure to uranium in drinking water may adversely affect kidney function and result in increased risk of cancer. In response to this EPA rulemaking, FDA published the March 3, 2003 direct final rule. This direct final rule ensures that the minimum quality of bottled water, as affected by uranium, combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity, remains comparable with the quality of public drinking water that meets EPA's standards.

 

III. QUESTIONS AND ANSWERS

  1. What is the allowable level established by FDA for uranium in bottled water?

    The allowable level established by FDA for uranium in bottled water is 30 micrograms per liter of water. (21 CFR 165.110(b)(5)(i)(D)).

  2. What analytical methods are used for determining compliance with the quality standard for uranium in bottled water?

    The analytical methods used for determining compliance with the quality standard for uranium in bottled water are as follows:

    • Method 7500-U B--"Radiochemical Method" which is contained in "Standard Methods for the Examination of Water and Wastewater," 20th Ed., and
    • Method 7500-U C--"Isotopic Method" which is contained in "Standard Methods for the Examination of Water and Wastewater," 20th Ed.

    ((21 CFR 165.110(b)(5)(ii)(D)).

  3. What analytical methods are used for determining compliance with the quality standard for combined radium-226/-228 in bottled water?

    The analytical methods used for determining compliance with the quality standard for combined radium-226/-228 are as follows:

    • Method 7500-Ra B--"Precipitation Method," which is contained in "Standard Methods for the Examination of Water and Wastewater," 20th Ed., and
    • Method 7500-Ra D--"Sequential Precipitation Method," which is contained in "Standard Methods for the Examination of Water and Wastewater," 20th Ed.

    (21 CFR 165.110(b)(5)(ii)(A)).

  4. What analytical method is used for determining compliance with the quality standard for gross alpha particle radioactivity in bottled water?

    The analytical method used for determining compliance with the quality standard for gross alpha particle radioactivity in bottled water is as follows:

    • Method 7110 C--"Coprecipitation Method for Gross Alpha Radioactivity in Drinking Water," which is contained in "Standard Methods for the Examination of Water and Wastewater," 20th Ed.

    (21 CFR 165.110(b)(5)(ii)(B)).

  5. What analytical methods are used for determining compliance with the quality standard for beta particle and photon radioactivity in bottled water?

    The analytical methods used for determining compliance with the quality standard for beta particle and photon radioactivity in bottled water are as follows:

    • Method 7500-Sr B--"Precipitation Method," which is contained in "Standard Methods for the Examination of Water and Wastewater," 20th Ed.,
    • Method 7500-3 H B--"Liquid Scintillation Spectrometric Method," which is contained in "Standard Methods for the Examination of Water and Wastewater," 20th Ed., and
    • Method 7120 B--"Gamma Spectroscopic Method," which is contained in "Standard Methods for the Examination of Water and Wastewater," 20th Ed.

    (21 CFR 165.110(b)(5)(ii)(C)).


(1)This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.