FDA Safety and Consumer Protections Are Often Less Stringent Than Comparable EPA Protections for Tap Water
GAO-09-610: Published: Jun 22, 2009. Publicly Released: Jul 8, 2009.
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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.
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.
Recommendations for Executive Action
Status: Closed - Implemented
Comments: On October 19, 2011, FDA published a final rule (76 FR 64810) establishing an allowable level of 0.006 mg/L for DEHP in the quality standard for bottled water. According to FDA, this final rule became effective April 16, 2012 and is intended to ensure that FDA's standards for the minimum quality of bottled water, as affected by DEHP, will be no less protective of the public health than those set by EPA.
Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the FDA to issue a standard of quality regulation for DEHP, or publish in the Federal Register the agency's reasons for not doing so 1 year after the conclusion of its task force study on this matter.
Agency Affected: Department of Health and Human Services
Status: Closed - Not Implemented
Comments: According to FDA, the agency has not been able to make significant progress in the development of this guidance due to limited resources and multiple higher priority assignments (e.g., development of final rules to implement relevant sections of the Patient Protection and Affordable Care Act, developing a final rule to define the term "gluten-free," and developing other proposed regulations to implement the FDA Food Safety and Modernization Act.
Recommendation: The Secretary of Health and Human Services should direct the Commissioner of the FDA to implement FDA's findings on methods that are feasible for conveying information about bottled water to customers, such as, at a minimum, requiring that companies provide on the label contact information directing customers on how to obtain comprehensive information. Should FDA determine that it lacks the necessary authority to implement its findings, it should seek legislation to obtain such authority.
Agency Affected: Department of Health and Human Services