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FDA regulations for bottled-water safety start with the most basic regulation for all food products -- bottled water must be packaged in a sanitary container and in a sanitary environment. Beyond the basic rules for packaged food, the FDA has specific rules for bottled water. First, it must come from an approved source, which doesn't mean the FDA goes and checks the source to make sure it's safe. It simply means the water must come from one of two places: a protected natural source, such as a spring or artesian well in which measures have been taken to assure against contamination by surface water; or a municipal source of drinking water (i.e. tap water). The FDA also has rules about how companies can label their bottled water. For instance, they are not allowed to flat-out lie about the water's source, and if the water originally came from an untreated municipal water source (water that wasn't potable when they bought it), they have to disclose that on the label. They also have to disclose if they have added anything to the water, such as fluoride or other minerals.

Other FDA bottled-water regulations determine the maximum levels of certain contaminants allowed, including organic (bacteria, viruses, parasites) and inorganic (radon, lead, arsenic). These regulations are based on the EPA's requirements for tap water, but there are differences. The FDA does not consider bottled water to be a risky food product for at least a couple of reasons: First, since the water's source must be protected in the first place, the water shouldn't be susceptible to many of the harmful contaminants found in surface and ground water, which municipal systems sometimes have to deal with; and second, there have been no instances to date of significantly contaminated bottles of water. There are contaminants in bottled water just like there are in tap water, but no testing has uncovered levels that would pose a health risk. So the FDA does not regulate bottled water as tightly as it regulates, say, prescription drugs.

In some areas, FDA regulations are actually stricter than the EPA's rules for tap water, as in the case of lead. Tap water, which travels through lead pipes to get to your faucet, is allowed to have up to 15 parts per billion (ppb) of lead by necessity, whereas bottled water can't have more than 5 ppb. But in most cases, the EPA standards for tap water are harder to meet. For example, whereas tap water is not allowed to contain any E.coli or fecal coliform bacteria at all (E.coli can cause illness, and fecal coliform can indicate the presence of disease-causing agents), bottled water is allowed to have trace amounts of these contaminants. Still, there have been no confirmed instances of finding either bacteria in any brand of bottled water, lending credence to the FDA's assertion that the risk is low. Also, cities must disinfect all potable water supplies and test for asbestos and parasites, while there are no matching FDA requirements for bottled-water companies.

At one level down from federal regulation, which only affects water that travels between states, there is state regulation of the industry. Many states have bottled-water regulations that are stricter than the FDA's, requiring bottled-water companies to obtain a yearly license and submit to regular inspection of water sources and treatment facilities. Some states don't regulate bottled water at all.

By far the tightest regulating body overseeing the bottled-water industry is the industry itself, most notably in the form of the International Bottled Water Association (IBWA). The IBWA enforces voluntary self-regulation of its members, who produce about 80 percent of the bottled water purchased in the United States. IBWA members must meet the requirements set forth in the IBWA Model Code, which includes disinfection in the form of reverse osmosis, filtration or distillation for any water drawn from a municipal drinking water source. (Companies using protected, natural sources are not required to disinfect the water.) IBWA members must also submit to an unannounced facility inspection once a year by a third-party organization. One independent group that tests bottled water for quality and compliance is the National Sanitation Foundation (NSF), which runs a voluntary Bottled Water Certification Program that includes water-source and plant inspection and the testing of both water (for contaminants) and container-sealing processes. See the NSF Product and Service Listing for a list of NSF-certified bottled waters.

You probably noticed a few things in the above discussion of regulations. For one thing, the FDA's and the states' regulations are the only ones that are not voluntary, and some states don't have regulations. So that leaves the FDA. And the FDA's regulations are based on the premise that bottled water is not a potential risk to public health. These are a couple of the points that contribute to the controversy surrounding bottled water. In the next section, we'll take a closer look at the issues.

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