Background
In the Federal Register of August 4, 1993 (58 FR 41612), FDA published a proposal to revise the
bottled water standard of quality regulations in 21 CFR part 103 (now 21 CFR 165.110(b)) to
establish or modify the allowable levels in bottled water for 5 inorganic chemicals and 18
synthetic organic chemicals, and to maintain the existing allowable level for the inorganic
chemical sulfate. As required under Section 410 of the Federal Food, Drug, and Cosmetic Act,
FDA proposed these revisions in response to the publication by the Environmental Protection
Agency (EPA) of a final rule (57 FR 31776; July 17, 1992) that established national primary
drinking water regulations consisting of maximum contaminant levels (MCLs) for the same 23
chemicals and establishing an MCL for sulfate in public drinking water under the Safe Drinking
Water Act. In a final rule published March 26, 1996 (61 FR 13258), FDA maintained its existing
allowable level for sulfate and adopted the proposed allowable levels for the 5 inorganic
chemicals and 17 of the synthetic organic chemicals. FDA deferred final action on the proposed
allowable level of 0.006 milligrams/liter (mg/L) for the chemical DEHP in response to a
comment.
In the Federal Register of April 1, 2010 (75 FR 16363), FDA reopened the comment period for
the 1993 proposed rule to seek further comment on finalizing the allowable level for DEHP in
the bottled water quality standard. In response to new information and comments received, FDA
published the October 19, 2011 final rule. This final rule ensures that FDA’s standards for the
minimum quality of bottled water, as affected by DEHP, will be no less protective of the public
health than those set by EPA for public drinking water.
