Beverages: Bottled Water

The Food and Drug Administration (FDA) is amending its bottled water quality standard regulations by establishing allowable levels for three residual disinfectants (chloramine, chlorine, and chlorine dioxide) and three types of disinfection byproducts (DBP's) (bromate, chlorite, and haloacetic acids (HAA5)). FDA also is revising the existing allowable level for the DBP total trihalomethanes (TTHM). Finally, FDA is revising, for the three residual disinfectants and four types of DBP's only, the monitoring requirement for source water found in the current good manufacturing practice (CGMP) regulations for bottled water. As a consequence of FDA's amending the quality standard for these residual disinfectants and DBP's, bottled water manufacturers are required to monitor their finished bottled water products for these disinfectants and DBP's at least once each year under the CGMP regulations for bottled water. Bottled water manufacturers also are required to monitor for these contaminants at least once each year in their source water, unless the bottlers meet the criteria for source water monitoring exemptions under the CGMP regulations. This direct final rule will ensure that the minimum quality of bottled water, as affected by the previously mentioned disinfectants and DBP's, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards. FDA is issuing a direct final rule for this action because the agency expects that there will be no significant adverse comment on this rule. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under the agency's usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event the agency receives significant adverse comment and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.