July 11, 2001—The Food and Drug Administration (FDA) has announced that it does not need to issue a standard of quality regulation for bottled water in response to the Environmental Protection Agency's (EPA's) issuance of National Primary Drinking Water Regulations (NPDWRs) for the control of Cryptosporidium contamination in surface water sources for public drinking water.
This action, announced in the Federal Register today, is in accordance with the Federal Food, Drug, and Cosmetic Act (the FFDCA), which requires that, whenever EPA issues NPDWRs for a contaminant in public drinking water, FDA must issue a standard of quality regulation for the same contaminant in bottled water or make a finding that such a regulation is not necessary to protect the public health because the contaminant is contained in water in public water systems but not in water used for bottled drinking water. EPA's Interim Enhanced Surface Water Treatment Rule established NPDWRs consisting of treatment technique requirements for reduction of Crypto in surface and some types of ground water.
Cryptosporidium is a gastrointestinal illness caused by ingestion of Cryptosporidium oocysts. The mode of transmission for Cryptosporidium is through the fecal-oral route and occurs by ingestion of infective oocysts from contaminated water or food, or by direct or indirect contact with infected persons or animals. While cryptosporidiosis generally is considered a self-limiting disease, it can be chronic and life threatening in immunocompromised individuals.
Recently, a waterborne outbreak of Cryptosporidium was documented in association with public drinking water.
Under the Safe Drinking Water Act (SDWA), as amended in 1996, EPA issues NPDWRs to protect the public health from the adverse effects of contaminants in public drinking water. NPDWRs specify maximum contaminant levels (MCLs) or treatment techniques for public drinking water contaminants. At the same time that it issues NPDWRs, EPA publishes maximum contaminant level goals (MCLGs), which are not regulatory requirements, but rather nonenforceable health goals that are based solely on considerations of protecting the public from adverse health effects of public drinking water contamination.
According to the FFDCA, FDA was required to issue a standard of quality regulation for the contaminant in bottled water or announce that such a regulation was unnecessary. Based on the reasoning that water bottling plants were using source water already treated by the city, FDA decided any further measures would be unnecessary.
For more information, visit http://www.epa.gov.
