FDA Proposes to Amend its Bottled Water Regulation

According to EPA, fecal pathogen-contaminated ground water was demonstrated by data to be associated with 68 waterborne disease outbreaks and 10,926 illnesses between 1991 and 2000, and CDC identified source water contamination and inadequate treatment as the likely cause of the outbreaks. Because of that data, EPA On Nov. 8, 2006, EPA published a new National Primary Drinking Water Regulation (NPDWR) on Nov. 8, 2006, relating to fecal contamination, which required the U.S. Food and Drug Administration either to issue a standard of quality regulation for that contaminant in bottled water or find such a regulation not necessary by Dec. 1, 2009. As reported in the Sept. 17 Federal Register, FDA has chosen to amend its bottled water regulation (at 21 CFR 129 and 165), making it at least as protective of public health as EPA's drinking water standards.

Under the federal Food, Drug, and Cosmetic Act, FDA is required to issue a standard of quality regulation for fecal pathogen contaminants in bottled water. As such, in its latest rulemaking FDA proposes to:

  • Require that source water, which is currently subject to weekly microbiological testing, be tested specifically for total coliform as is done for finished bottled water products.
  • Require bottled water manufacturers to test for the bacterium Escherichia coli (E. coli), an indicator of fecal contamination, if any coliform organisms are detected in source water or finished bottled water products.
  • Amend the adulteration provision of the bottled water standard to reflect the possibility of filth. Bottled water containing E. coli would be considered adulterated, and source water containing E. coli would not be considered to be of a safe, sanitary quality and would be prohibited from use in the production of bottled water.
  • Require bottlers to rectify or eliminate the source of E. coli contamination in source water and keep records of such actions. Existing regulatory provisions would require bottled water manufacturers to keep records of new testing required by this rule.

FDA tentatively concludes that this proposed rule, if finalized, will ensure that its standards for the minimum quality of bottled water, as affected by fecal contamination, will be no less protective of the public health than those set by EPA for public drinking water. To access the proposed rule, go to http://edocket.access.gpo.gov/2008/pdf/E8-21619.pdf.

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