Bottled Water Regulation

Bottled water regulation is at least as stringent as tap water regulation. Yet a key line of attack against bottled water comes from environmental activists and others who complain that bottled water does not comply with the EPA standards for tap water, suggesting that bottled water standards are lower. As a result, they say, bottled water quality may not even be as good a tap water quality. These arguments were outlined in the “study” released by the Natural Resources Defense Council in 1999. However, such arguments don’t mesh with reality.

The EPA sets standards for tap water under the Safe Drinking Water Act (SDWA) and the Food and Drug Administration (FDA) sets standards for bottled water under the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA regulations are based on EPA standards and are mostly the same, with the exception of a few areas where tap water regulations don’t make sense or where the FDA includes additional or more stringent requirements. According to the EPA, both sets of standards produce bottled and tap water that is safe.

Under the SDWA, the EPA regulates more than 80 drinking water contaminants that might be found in the water of public water systems. For each regulated contaminant, the EPA usually specifies a maximum contaminant level goal (MCLG), which represents the level of a contaminant that the EPA ideally wants to allow in drinking water. The EPA uses the MCLG as a guide in setting the enforceable standard, the maximum contaminant level (MCL). The MCL represents the amount of that contaminant that systems may legally allow in tap water. For example, the EPA allows systems to provide only drinking water that contains no more than 0.005 milligrams of benzene per liter of water. When the EPA determines that it is technically or economically infeasible to monitor for a contaminant, it is directed by Congress to promulgate mandatory “treatment techniques,” such as mandatory installation of filtration devices.

The FFDCA requires that the FDA apply SDWA standards to the extent they make sense for bottled water. Its version of an MCL is a Standard of Quality (SOQ). And according to the FFDCA, SOQs must be “no less stringent” than EPA MCLs and “no less protective” than EPA treatment techniques. In other words, the FDA has two choices when setting a regulation. It must either be equivalent to EPA standards or it must be more stringent. The law does not allow the FDA to set standards that produce a lower quality product.

When deciding on an SOQ, the FDA must review EPA regulations for tap water once the EPA finalizes or revises them to assess whether they are applicable to bottled water. If the FDA finds that the tap water regulations are applicable, it must propose those same regulations for bottled water within 180 days after the EPA issues the tap water standards. The SDWA of 1996 demands that if the FDA fails to act, the EPA tap water regulations become the standards for bottled water. As a result, the FDA has overwhelmingly applied the EPA’s tap water standards to bottled water. [See Appendix A at the end of this document; It offers a comparison of FDA and EPA standards. Like the EPA, the FDA requires that the water be tested regularly to ensure that standards are met.

There are some cases where the standards vary because of differences between delivery systems. Since tap water travels through pipes, regulations need to address potential contamination from pipes. Sanitary packaging for bottled water means that regulations related to food and food packaging apply to bottled water.

FDA regulations are more stringent for some chemicals, including regulations of lead, copper, fluoride, and phenols. Henry Kim, Ph.D., a supervisory chemist at the FDA’s Center for Food Safety and Applied Nutrition, Office of Plant and Dairy Foods and Beverages points out the difference between regulations for lead in both tap and bottled water. He notes that EPA standards tolerate a higher level of lead than FDA standards for bottled water, because lead can leach from the pipes into water before it reaches the tap, making it more difficult to control. The EPA requires that tap water contain no more than 15 parts per billion of lead, while the FDA standard is much more stringent at 5 parts per billion. The FDA opts for a more stringent standard simply because it is more readily attainable for bottled water.

 Some tap water regulations don’t apply to bottled water because the issues they address deal with tap water purification issues and pipe delivery. For example, the EPA regulates two substances—acrylamide and epichlorohydrin—simply because they are used in tap water treatment plants and can enter the water there. But these substances are not used to purify or package bottled water and hence are not an issue and do not warrant FDA regulation. The FDA also does not have a regulation for asbestos because they are not a problem in bottled water sources. The EPA regulates asbestos because it is used in cement pipes that distribute tap water. The FDA does not employ the EPA regulation for phthalates because the FDA applies standards related to food additives to ensure that such chemicals remain at levels below health concerns. Moreover, most bottled water comes in Polyethylene terephthalate (PETE or PET) plastic containers, which do not contain phthalates. The FDA does not apply EPA’s Enhanced Surface Water Treatment Rule since it applies to surface water. Bottled water typically comes from underground sources or from tap water that has already complied with the surface water rule.

When it comes to managing microbiological agents, FDA regulations vary from the EPA’s, but again, they must be “no less protective.” Instead of mandating specific filtration or disinfection methods, FDA mandates that water meet the same standards as all food products. These include sanitary production and packaging regulations as well as rules to ensure products are not “adulterated” with any harmful substance. In other words, the FDA regulates the final product and gives bottled water companies some leeway in how they reach that level of quality. The FDA explains:

“These regulations require that bottled water be safe and that it be processed, bottled, held and transported under sanitary conditions. Processing practices addressed in the CGMP regulations include protection of the water source from contamination, sanitation at the bottling facility, quality control to assure the bacteriological and chemical safety of the water, and sampling and testing of source water and the final product for microbiological, chemical, and radiological contaminants. Bottlers are required to maintain source approval and testing records to show to government inspectors. Checking adherence to part 129 regulations is an important part of FDA inspections of bottled water plants.”

Essentially, this means that when companies bottle water, the product must not present any human health threat, and the company must be able to demonstrate that fact to the FDA inspectors or face enforcement penalties. Specifically, regulations demand that bottled water not be adulterated any “deleterious substance that may be injurious to health,” which includes additives from the containers that might enter the water in trace amounts.

There are many good reasons why the FDA takes this approach. In particular, one of the qualities that many consumers like about bottled water is that many kinds come from natural sources and are not subject to the types of treatment techniques—such as chlorination—that affect the flavor of the product. And chlorination is not necessary for bottled water as it is for tap water, because bottled water is not delivered to the consumer via pipes, where it can become contaminated. Sanitary packaging essentially performs the role that chlorine does during pipe transport to consumers. Moreover, much bottled water comes from groundwater sources, which according to the EPA, is less likely to become contaminated, and hence does not require the same kind of disinfection. According to the EPA, “Ozone is preferred by bottlers, though it is more expensive than chlorine, because it does not leave a taste and because bottlers do not need to worry about maintaining disinfectant in water sealed in a container. Untreated water, whether from a bottle or from a tap, will have the characteristic taste of its source.” The International Bottled Water Association reports that its members provide 85 percent of the bottled water in the United States. Membership demands that companies employ a multi-barrier approach which may include steps such as source protection, source monitoring, reverse osmosis, micron filtration, distillation, ozonation and final disinfection.” Consumers can contact companies to learn about disinfection techniques before selecting a brand if the information does not already appear on the label.

Information found on the label is also regulated by the FDA. Labeling regulations demand that bottled water labels contain only accurate information. Products that don’t meet FDA standards are considered “misbranded.” Regulatory definitions for specific terms—“ground water,” “mineral water,” “purified water,” “sparkling water”—are all defined in FDA regulations (See Table I in this FDA document).

Bottled water providers must also meet “Good Manufacturing Practices.” Under these regulations, source water must come from an approved source that meets all the laws and regulations of the government that has jurisdiction of the water source. Good manufacturing practices also include regulations on processing, packaging, transport, and storage to ensure sanitary conditions. They also mandate that bottled water companies regularly monitor the water source and final products to ensure they comply with safety regulations. Other regulations involve specific identity and quality requirements for bottled water.

Nonetheless, some environmental activists have suggested that bottled water is of a lower quality because FDA only regulates water in “interstate commerce.” They suggest that a large share of bottled water is produced solely intrastate and hence they lead the public to believe that such water must be of a lower quality because it does not fall under FDA jurisdiction. For example, a Natural Resources Defense Council activist suggested in congressional testimony that as much as 40 percent of bottled water isn’t covered by FDA regulations. The figure appears to be the result of pure, but even if this claim were correct, it should not be at all alarming. In addition to the fact that states regulate bottled water to ensure safety, bottled water has a tremendous safety record, with very few problems reported. The next section of this paper compares that record to tap water and finds that there have been far fewer health-related problems associated with bottled water.

In any case, the idea that bottled water providers produce water that is lower quality than demanded by FDA is highly unlikely. In fact, the data in NRDC’s own report on bottled water shows that an overwhelming majority of bottled water meets or exceeds federal water standards. According to NRDC it “commissioned independent lab testing of more than 1,000 bottles of 103 types of bottled water from many parts of the country.” NRDC reports that only “four waters” failed (two exceeded standards for fluoride and two for coliform bacteria) to meet federal standards. The NRDC claims that this amounts to 4 percent failure rate, which indicates a success rate of upwards of 96 percent. That is an impressive record.

Moreover, given the broad definition of interstate commerce, it is unlikely that anyone could make a legal case that any bottled water doesn’t fall under FDA’s jurisdiction. In fact, “interstate commerce” covers most all commercial activity. For example in Wickard v. Filburn, wheat grown in a farm and consumed on a farm is considered to be part of interstate commerce because interstate commerce is affected because the farmer does not have to buy wheat in the marketplace. In Gonzales v. Raich, marijuana grown in a home for medicinal use under California law was considered interstate commerce and subject to federal law as well. In addition, if any part of a food product or packaging involves accessing materials that are produced or affect interstate, the produce it covered. Finally, the Food, Drug, and Cosmetics Act says that courts shall presume for enforcement purposes all food products, including bottled water, are part of interstate commerce. Specifically, 21 U.S.C. §379a of the law reads: “In any action to enforce the requirements of this Act respecting a device, food, drug, or cosmetic the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist.”

In Senate testimony the NRDC admits that the most likely case is that bottled water falls under FDA jurisdiction. In a footnote to the claim that the water isn’t regulated by FDA, the NRDC staffer notes: “However, the bottled water industry, by and large, has a significant effect on interstate commerce and many of the products used in the bottling plants—such as the bottles, labels, the caps—move through interstate commerce even if the source of the water may be intrastate. Given the prevalence of moving plastic bottled through interstate commerce, most, if not all, bottled water should fall under FDA’s watch.”

Bottled water providers also must comply with other standards—both public and private. There are state-level regulations, some of which, such as those from California, Pennsylvania, and Florida, are more stringent than federal regulations. In addition, the International Bottled Water Association membership—which covers 85 percent of bottled water—comply with even stricter industry standards. In addition, the association’s membership is subject to unannounced sanitary inspections by two independent groups—the National Sanitation Foundation (NSF) and Underwriters Laboratories (UL).

In the rare case that a bottle of water does not meet a standard, or when it doesn’t meet a California standard, there still is no public health consequence. In fact, a high success rate of meeting EPA/FDA standards indicates that bottled water meets an exceedingly high safety standards. EPA regulators design the regulations with safety factors to ensure that even if consumers are exposed to contamination many times higher than levels allowed by regulation, they would not suffer any public health impact, despite claims by environmental activists suggesting that trace level chemicals in our water may give us cancer. In their landmark study on cancer, scientists Richard Doll and Richard Peto noted back in 1981 when standards were not nearly as stringent: “With the possible exception of asbestos in a few water supplies, we know of no established human carcinogen that is ever present in sufficient quantities in large U.S. water supplies to account for any material percentage of the total risk of cancer.”

A periodic exceedance for chemical contaminants should be of little concern. In fact, EPA regulations do not expect every sample to meet their standards for chemical contaminants. Instead, the levels are averaged over a period of time because the risks of such trace-level chemicals are associated with long-term exposures to contaminants at vastly higher levels over a long period of time. Periodic exceedances of the exceptionally cautious standards are of no consequence, particularly since exceedances were on the order of one to a few parts per billion. Of note, bottled water still meets an even more stringent standard on this point. Unlike EPA regulations for tap water, bottled water companies are not expected to meet the standard on average. They must meet it with every single sample. That makes FDA standards more stringent in this respect.

Finally, environmental activists also suggest that bottled water testing is insufficient compared to tap water regulations. NRDC notes that tap water regulations require local governments to test for bacteria and chemical contaminants far more often than bottled water companies. But there are good reasons for these differences. Tap water must be tested frequently because it source and delivery system mean it is much more likely to become contaminated. Indeed, tap water often comes from surface water sources and then travels through pipes. Moreover, when you consider the volume of water tested, bottled water receives more testing per gallon of water.

Given that bottled water largely meets or exceeds federal tap water standards, there is little reason to fear. In fact, the next section shows that bottled water quality is often higher than tap water quality and that it suffers less often from dangerous contamination problems.