Beverages: Bottled Water Quality Standard; Establishing an Allowable Level for di(2-ethylhexyl)phthalate
other · Food and Drug Administration · Rule · Published 2011-10-19 · Effective 2012-04-16 · 76 FR 64810
Document
Document number
2011-26707
Federal Register citation
76 FR 64810
CFR reference
21 CFR 165
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2011-10-19
Effective date
2012-04-16
HHS docket
Docket No. FDA 1993-N-0259 (Formerly Docket No. 1993N-0085)
Abstract
The Food and Drug Administration (FDA) is amending its bottled water quality standard regulations by establishing an allowable level for the chemical di(2-ethylhexyl)phthalate (DEHP). As a consequence, bottled water manufacturers are required to monitor their finished bottled water products for DEHP at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water. Bottled water manufacturers are also required to monitor their source water for DEHP as often as necessary, but at least once every year unless they meet the criteria for source water monitoring exemptions under the CGMP regulations. This final rule will ensure 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 the Environmental Protection Agency (EPA) for public drinking water.