DECEMBER 12, 2001
THE FOOD AND DRUG ADMINISTRATION DOES NOT NEED TO PROMULGATE UNREGULATED CONTAMINANT MONITORING REGULATIONS BECAUSE THERE IS NO SCIENTIFIC BASIS
The U.S. Environmental Protection Agency (EPA) has promulgated a series of regulations that require public drinking water systems to monitor for “unregulated contaminants,” i.e., contaminants that do not have water quality standards or Maximum Contaminant Levels (MCLs) (64 Fed. Reg. 50556, 65 Fed. Reg.11372, 65 Fed. Reg. 2273). This monitoring program is designed to generate data for use by EPA in deciding whether there is a scientific basis for developing public drinking water standards for these contaminants.
EPA’s statutory basis for issuing this regulation can be found in Safe Drinking Water Act (SDWA) section 1445(a)(2), which requires EPA to establish criteria for a program to monitor unregulated contaminants. Since the unregulated monitoring program is not a formal drinking water standard, there is no need or scientific basis for the Food and Drug Administration (FDA) to adopt a bottled water regulation for these substances.
Section 410 of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires that FDA review all EPA national primary drinking water regulations (NPDWR) for public drinking water systems and determine whether they are applicable to bottled water. FDA must propose regulations for bottled water within 180 days after the effective date of EPA’s public water standards or make a finding that such a regulation is not applicable to bottled water.
Section 410 of the FFDCA (21 U.S.C. 349) directs FDA to promulgate a standard of quality regulation 180 days before the effective date of an NPDWR promulgated under section 1412 of the Safe Drinking Water Act. Since the unregulated monitoring program is not a formal drinking water standard, there is no need for FDA to adopt a regulation for bottled water for these substances. Furthermore, current science does not support regulation of the EPA unregulated substances in drinking water or bottled water at this time.