FDA’s Bottled Water Standard of Quality Regulations Are Similar to EPA’s Drinking Water Standards, but the Agency’s Authority to Enforce Them Is Weaker

FDA’s bottled water standard of quality regulations, for the most part,  mirror EPA’s drinking water requirements, although the case of DEHP (an  organic compound widely used in the manufacture of polyvinyl chloride  plastics) is a notable exception. Although FDA proposed a  standard in August 1993, the agency subsequently deferred action on  DEHP and has yet to either adopt a standard or publish a reason for not  doing so. Among our key findings are that (1) when  compared with EPA’s regulation of public water systems, several key  differences reflect the limited nature of FDA’s regulation of bottled water,  particularly regarding how violations are reported and whether the use of  certified laboratories is required; (2) because FDA’s experience over the  years has not shown that bottled water poses a significant public health  risk, the agency devotes fewer resources to the enforcement of bottled  water regulations than it does for higher risk foods; (3) while state  regulatory requirements for bottled water often meet or exceed those of  FDA, the requirements vary across the states and, in some states, are still  less comprehensive than state requirements for tap water under the Safe  Drinking Water Act; and (4) FDA’s oversight of imported bottled water is  limited. How violations are reported: The FFDCA does not specifically authorize  FDA to require bottlers to report test results, even if violations of the  standard of quality regulations are found. Our survey of 50 states and the District of Columbia identified variability  in their requirements in governing certain key practices that protect and  ensure bottled water quality and safety. FDA and State Bottled Water Labeling Requirements Resemble Those for Other Food Types, but Demand Less Information Than Is Required for Tap Water

		FDA Regulations Require Bottled Water Labels to Contain Specific Information, in Addition to Information Required for All Food Products

Because it is considered a food, bottled water must comply with FDA’s  general requirements for food labeling, which include ingredient and  nutrition information. In addition, like other  food products, bottled water is subject to the same general prohibitions  against misbranding. In its 2000 report, FDA concluded that certain  methods were feasible for the bottled water industry to provide the same  type of information to consumers that the Safe Drinking Water Act  requires public water systems to provide in an annual consumer  confidence report—including the source and levels of contaminants tested  for and found in the water. Nonetheless, the agency was not required to take action on its  findings and has yet to do so. Additional Information about Bottled Water Would Be Beneficial to Consumers

Our work suggests that consumers may benefit from additional  information. For example, when asked whether consumers in their state  had misconceptions about bottled water, 24 of the 51 state and District of  Columbia officials responding to our survey replied that consumers  believe that bottled water is safer, is healthier, or is of higher quality than  tap water. Nonetheless, our review of bottled water labels revealed that, when  compared with what public water systems are required to provide to  consumers of tap water, very few bottled water facilities provide such  information to consumers, either through labels, company Web sites,  telephone calls to company representatives, or any combination of these  avenues. Representatives of the beverage  industry and an environmental nonprofit organization reported that about  827,000 to 1.3 million tons of PET plastic water bottle containers were  produced in the United States in 2006. Second, although the overall production and consumption of bottled water  makes up a small share of the total U.S. energy demand, bottled water is  much more energy-intensive than public drinking water. GAO staff who made major contributions to  this report are listed in appendix V.

Appendix I: Scope and Methodology

To evaluate the extent to which federal and state authorities regulate the  quality of bottled water to ensure it is safe and the extent to which they  regulate the accuracy of labels or claims about the purity and source of  bottled water, we reviewed federal and state bottled water regulations. To identify the environmental and other impacts of bottled water, we  reviewed the following three subtopics: (1) the impact of discarded water  bottles on municipal landfill capacity; (2) the effects on U.S. energy  demands from the manufacture and transport of plastic bottles for  drinking water; and (3) the impacts, if any, on communities and the  environment of groundwater extraction for the purposes of bottling water.
Why GAO Did This Study

Over the past decade, per capita consumption of bottled water in the United States has more than doubled. With this increase have come several concerns in recent years about the safety, quality, and environmental impacts of bottled water. The Food and Drug Administration (FDA) regulates bottled water under the Federal Food, Drug, and Cosmetic Act as a food and is responsible for ensuring that domestic and imported bottled water is safe and truthfully labeled. Among other things, GAO (1) evaluated the extent to which FDA regulates and ensures the quality and safety of bottled water; (2) evaluated the extent to which federal and state authorities regulate the accuracy of labels and claims regarding the purity and source of bottled water; and (3) identified the environmental and other impacts of bottled water. GAO reviewed FDA data, reports, and requirements for bottled water; conducted a state survey of all 50 states and the District of Columbia; reviewed bottled water labels; and interviewed FDA officials and key experts.

What GAO Found

FDA's bottled water standard of quality regulations generally mirror the Environmental Protection Agency's (EPA) national primary drinking water regulations, as required by the Federal Food, Drug, and Cosmetic Act, although the case of DEHP (an organic compound used in the manufacture of polyvinyl chloride plastics) is a notable exception. Specifically, FDA deferred action on DEHP in a final rule published in 1996 and has yet to either adopt a standard or publish a reason for not doing so. GAO also found that FDA's regulation of bottled water, particularly when compared with EPA's regulationof tap water, reveal key differences in the agencies' statutory authorities. Of particular note, FDA does not have the specific statutory authority to require bottlers to use certified laboratories for water quality tests or to report test results, even if violations of the standards are found. Among GAO's other findings, the state requirements to safeguard bottled water often exceed FDA's, but still are often less comprehensive than state requirements to safeguard tap water. FDA and state bottled water labeling requirements are similar to labeling requirements for other foods, but the information provided to consumers is less than what EPA requires of public water systems under the Safe Drinking Water Act. Like other foods, bottled water labels must list ingredients and nutritional information and are subject to the same prohibitions against misbranding. In 2000, FDA concluded that it was feasible for the bottled water industry to provide the same types of information to consumers that public water systems must provide. The agency was not required to conduct rulemaking to require that manufacturers provide such information to consumers, however, and it has not done so. Nevertheless, GAO's work suggests that consumers may benefit from such additional information. For example, when GAO asked cognizant officials in a survey of the 50 states and the District of Columbia, whether their consumers had misconceptions about bottled water, many replied that consumers often believe that bottled water is safer or healthier than tap water. GAO found that information comparable to what public water systems are required to provide to consumers of tap water was available for only a small percentage of the 83 bottled water labels it reviewed, companies it contacted, or company Web sites it reviewed. Among the environmental impacts of bottled water are the effects on U.S. municipal landfill capacity and U.S. energy demands. Regarding impacts on landfill capacity, GAO found that about three-quarters of the water bottles produced in the United States in 2006 were discarded and not recycled, on the basis of figures compiled by an industry trade association and an environmental nonprofit organization. Discarded water bottles, however, represented less than 1 percent of total municipal waste that EPA reported entered U.S. landfills in 2006. Regarding the impact on U.S. energy demands, a recent peer-reviewed article found that the production and consumption of bottled water comprises a small share of total U.S. energy demand but is much more energy-intensive than the production of public drinking water.