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Water Quality
6/27/2009 1:08:25 PM EST
Thomas H. Clarke, Jr.
Standards for bottled water tightened by FDA
Partner, Ropers Majeski Kohn & Bentley
Prior posts have noted the controversy surrounding the purity of bottled water. See, for example, http://www.nrdc.org/water/drinking/nbw.asp and http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/10/15/MNGV13H0L4.DTL. Prior posts have also noted that some jurisdictions (e.g., SF) have stopped the purchase and use of bottled water out of cost and environmental concerns about plastic waste. See http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/03/01/BAMS164JUC.DTL. Another concern noted in prior posts is the presence of BPA (an endocrine disruptor) in liquids in plastic bottles. See, for example, http://www.scientificamerican.com/article.cfm?id=plastic-not-fantastic-with-bisphenol-a.
 
FDA has now mandated that, starting in December, suppliers of bottled water must test source water for total coliform bacteria contamination. 74 Fed. Reg. 26,252. If any coliform organisms are detected, then the bottler has to ascertain if they are E. coli, seen as an indication of fecal contamination. Source water with E. coli is considered unsafe and may not be used.
 
Similarly, tougher standards are imposed on the quality of the finished water. 74 Fed. Reg. 25,651. Finished water must currently be tested for total coliform. The new rule requires assessing if E. coli is present; if so, then the water is considered "adulterated" by filth and may not be sold.
 
Consistent with the Small Business Regulatory Enforcement Fairness Act (PL 104-121), FDA has also issued a compliance guide related to the 2001 rule on allowable levels of and monitoring requirements for three residual disinfectants and four types of disinfection byproducts.
 
The final rules described above can be found at http://edocket.access.gpo.gov/2009/E9-12494.htm.

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