The Food and Drug Administration (FDA) has announced changes to its bottled water quality standard “by establishing an allowable level for the chemical di(2-ethylhexyl)phthalate (DEHP).” Effective April 16, 2012, the final rule establishes “in § 165.110(b)(4)(iii)(C) (21 CFR 165.110(b)(4)(iii)(C)), which includes allowable levels for pesticides and other synthetic organic chemicals, an allowable level for DEHP at 0.006 mg/L.” It also requires manufacturers to monitor their products “for DEHP at least once each year under the current good manufacturing practice (CGMP) regulations” and to monitor their source water “as often as necessary, but at least once every year unless they meet the criteria for source water monitoring exemptions under the CGMP.”

According to FDA, the amended rule brings bottled water standards in line with those set by the Environmental Protection Agency (EPA) for public drinking water. The two comments opposing the rule change evidently did not provide enough evidence to challenge FDA’s finding “that long-term, chronic exposure to DEHP above the MCL [maximum contaminant level] of 0.006 mg/L may have the potential to cause health effects in humans including damage to liver and testes, reproductive effects, and cancer.”

“By finalizing the allowable level for DEHP in the bottled water quality standard, FDA is meeting the requirement in the [Food, Drug, and Cosmetic Act] to amend its regulations for bottled drinking water in response to EPA’s establishment of an MCL for DEHP,” states the October 20, 2011, Federal Register notice. “Although DEHP is not expected to be found in bottled water in levels above the standard, FDA concludes that this rule is protective of public health because it will ensure that, should current conditions change, such as new sources of water or new manufacturing practices, the level of DEHP will remain low.”