FDA Says No to E.coli in Bottled Water. Really!?!

E. coli in bottled water not acceptable: FDA
6/8/2009 5:26:23 PM
 
WASHINGTON — The US Food and Drug Administration (FDA) has amended federal regulations regarding bacteria in bottled water, publishing in the May 29 Federal Register a final rule establishing a zero tolerance for E. coli bacteria in bottled water.

The International Bottled Water Association (IBWA) on May 28 announced its long-standing support of a zero-tolerance standard of quality for E.coli.

According to the IBWA announcement, “In fact, FDA’s final rule reflects IBWA’s ‘Code of Practice’ standard which was adopted in 1999 and which all IBWA bottler members must meet.”

Both the FDA and IBWA refer to the stricter regulation as an extra measure of safety for the consumer.

IBWA President and CEO Joe Doss is quoted in the IBWA announcement as saying, “Our members work hard and long to protect against E. coli. Now it’s the law of the land for all bottled water products.”

The FDA rule was promulgated under Section 410 of the Food, Drug, and Cosmetic Act, which requires that FDA’s bottled water regulations be as protective of the public health as the US Environmental Protection Agency’s (EPA) tap water standards. EPA issued its new National Primary Drinking Water Regulation, the Ground Water Rule, on November 6, 2006, which provides for increased protection against fecal microbial pathogens in public water systems that use groundwater sources. The EPA and FDA rule both become effective on December 1, 2009.

The primary elements of the new FDA rule are:
● Bottled water manufacturers that obtain their source water from other than a public water system must test their source water at least weekly for total coliform. If that source water is total coliform-positive, the manufacturer must conduct follow-up testing to determine whether any of the total coliform organisms are E. coli.
● Source water found to contain E. coli will not be considered water of a safe, sanitary quality as required for use in bottled water.
● Before a bottler can use water from a source that has tested positive for E. coli, the bottler must take appropriate measures to rectify or otherwise eliminate the cause of E. coli contamination of that source in a manner sufficient to prevent its occurrence. A source previously found to contain E. coli will be considered negative for E. coli after five samples collected over a 24-hour period from the same sampling site that originally tested positive for E. coli are tested and found to be E. coli negative.
● Bottlers must maintain records of corrective measures taken to rectify or eliminate E. coli contamination.
● If any coliform organisms are detected in weekly total coliform testing of finished bottled water, follow-up testing must be conducted to determine whether any of the coliform organisms are E. coli.
● Analyses conducted to determine compliance with the standards for microbiological quality for total coliform and E. coli must be made in accordance with the multiple-tube fermentation (MTF) method and membrane filter (MF) methods.
● If E. coli is present in bottled water, then the bottled water is deemed to be adulterated under section 402(a)(3) of the Federal Food Drug and Cosmetic Act (FDCA) and is banned from sale or distribution.

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