Fed Regist. 2009 May 29;74(102):25651-65.
The Food and Drug Administration (FDA) is amending its bottled water regulations to require that bottled water manufacturers test source water for total coliform, as is required for finished bottled water products, and to require, if any coliform organisms are detected in source water, that bottled water manufacturers determine whether any of the coliform organisms are Escherichia coli (E. coli), an indicator of fecal contamination. FDA also is amending its bottled water regulations to require, if any coliform organisms are detected in finished bottled water products, that bottled water manufacturers determine whether any of the coliform organisms are E. coli. FDA also is amending the adulteration provision of the bottled water standard to reflect the possibility of adulteration caused by the presence of filth. Bottled water containing E. coli will be considered adulterated, and source water containing E. coli will not be considered to be of a safe, sanitary quality and will be prohibited from use in the production of bottled water. FDA is also amending its bottled water regulations to require that, before a bottler can use source water from a source that has tested positive for E. coli, the bottler must take appropriate measures to rectify or eliminate the cause of E. coli contamination of that source, and that the bottler must keep records of such actions. Existing regulatory provisions require bottled water manufacturers to keep records of new testing required by this rule. This final rule will ensure that FDA's 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 the Environmental Protection Agency (EPA) for public drinking water.
美国食品药品监督管理局(FDA)正在修订其瓶装水法规,要求瓶装水制造商按照成品瓶装水产品的要求对源水进行总大肠菌群检测;并且,如果在源水中检测到任何大肠菌群生物,要求瓶装水制造商确定其中是否有任何大肠菌群生物为大肠杆菌(E. coli),这是粪便污染的一个指标。FDA还在修订其瓶装水法规,要求如果在成品瓶装水产品中检测到任何大肠菌群生物,瓶装水制造商需确定其中是否有任何大肠菌群生物为大肠杆菌。FDA还在修订瓶装水标准中的掺假条款,以反映因存在污物而导致掺假的可能性。含有大肠杆菌的瓶装水将被视为掺假产品,而含有大肠杆菌的源水将不被视为具有安全、卫生的质量,并且将被禁止用于生产瓶装水。FDA还在修订其瓶装水法规,要求瓶装商在使用来自大肠杆菌检测呈阳性水源的源水之前,必须采取适当措施纠正或消除该水源大肠杆菌污染的原因,并且瓶装商必须记录这些行动。现有监管规定要求瓶装水制造商保存本规则要求的新检测记录。本最终规则将确保FDA关于受粪便污染影响的瓶装水最低质量标准对公众健康的保护程度不低于环境保护局(EPA)为公共饮用水设定的标准。