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Before the Subcommittee on Oversight and Investigations, Committee on 
Energy and Commerce, House of Representatives: 

United States Government Accountability Office: 

For Release on Delivery: 
Expected at 10:00 a.m. EDT:
Wednesday, July 8, 2009: 

Bottled Water: 

FDA Safety and Consumer Protections Are Often Less Stringent Than 
Comparable EPA Protections for Tap Water: 

Statement of John Stephenson, Director: 
Natural Resources and Environment: 


[End of section] 

July 8, 2009: 

Mr. Chairman and Members of the Subcommittee: 

I am pleased to be here today to discuss the quality and safety of 
bottled water and its environmental impacts. Over the past decade, the 
per capita consumption of bottled water in the United States has more 
than doubled--from 13.4 gallons per person in 1997 to 29.3 gallons per 
person in 2007. With this increase have come several concerns, raised 
by public interest groups in recent years, over bottled water's quality 
and safety. For example, water quality testing conducted by some of 
these groups, and others, has shown that bottled water does not 
necessarily have lower levels of contamination than tap water. 
Furthermore, bottled water's potential environmental impact has also 
come under scrutiny. Several organizations have raised concerns about a 
low recycling rate for plastic water bottles, the amount of energy used 
to manufacture and transport the product, and the impact of groundwater 
extraction on local resources. My testimony is based on our June 2009 
report,[Footnote 1] which is being publicly released today and 
addresses three issues: (1) the extent to which federal and state 
authorities regulate the quality of bottled water to ensure its safety, 
(2) the extent to which federal and state authorities regulate the 
accuracy of labels or claims regarding the purity and source of bottled 
water, and (3) the environmental impacts of bottled water. 

To address these questions, we reviewed relevant Food and Drug 
Administration (FDA) documents, policies, and guidance, as well as 
related laws and regulations pertinent to the oversight of bottled 
water at the federal and state levels; analyzed data from the FDA 
databases that track inspections, import examinations, and recalls; 
conducted a survey of all 50 states and the District of Columbia; and 
conducted interviews with Environmental Protection Agency (EPA) and FDA 
officials and a variety of experts from nonprofit organizations and 
industry associations. We also examined bottled water labels and 
contacted companies to determine what information they provide to 
consumers.[Footnote 2] Finally, we interviewed experts and other 
knowledgeable officials and reviewed the literature regarding the 
environmental impacts of bottled water. A full description of our scope 
and methodology is included in appendix I of our report. 

We conducted this performance audit from June 2008 to June 2009, in 
accordance with generally accepted government auditing standards. Those 
standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives. 

Mr. Chairman, the following summarizes our findings on each of the 
three issues discussed in our report: 

* Federal and state regulation of the quality of bottled water. FDA's 
bottled water standard of quality regulations generally mirror EPA's 
national primary drinking water regulations under the Safe Drinking 
Water Act, as required by the Federal Food, Drug, and Cosmetic Act 
(FFDCA) as amended, although the case of DEHP (an organic compound 
widely 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, even though FDA's statutory deadline 
for acting on DEHP was more than 15 years ago. More broadly, we found 
that FDA's regulation of bottled water (including its implementation 
and enforcement), particularly when compared with EPA's regulation of 
tap water, reveals 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 our other findings, the states' 
requirements to safeguard bottled water often exceed those of FDA, but 
are still often less comprehensive than state requirements to safeguard 
tap water. 

* Federal and state regulation of the accuracy of labels or claims of 
purity. 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. Public water systems must annually 
provide consumer confidence reports that summarize local drinking water 
quality information about the water's sources, detected contaminants, 
and compliance with national primary drinking water regulations as well 
as information on the potential health effects of certain drinking 
water contaminants. FDA does not require bottled water companies to 
provide this information. Rather, as in the case of other foods, 
bottled water labels are required to 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. However, the agency 
was not required to conduct a rulemaking requiring that manufacturers 
provide such information to consumers, and has yet to do so. 
Nevertheless, our work suggests that consumers may benefit from such 
additional information. For example, when we 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. Their responses were consistent with a 2002 EPA-sponsored 
Gallup survey, which found that the main reason consumers either 
filtered tap water or purchased bottled water was due to health-related 
concerns. We also 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 we 
reviewed, companies we contacted, or company Web sites we reviewed. 

* The environmental impacts of bottled water. Among the environmental 
impacts of bottled water are its effects on U.S. municipal landfill 
capacity and U.S. energy demands. Regarding its impacts on landfill 
capacity, we 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.[Footnote 3] Regarding the 
impact on U.S. energy demands, a recent peer-reviewed article noted 
that while the production and consumption of bottled water comprises a 
small share of total U.S. energy demand, it is much more energy- 
intensive than the production of public drinking water.[Footnote 4] 

Our report released today recommends that the Secretary of Health and 
Human Services direct the Commissioner of 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 the issue. FDA generally concurred with the 
recommendation, agreeing that it should reassess whether to issue the 
regulation for DEHP as soon as possible after the conclusion of the 
task force study on phthalates.[Footnote 5] The report also recommends 
that FDA implement its findings on methods that are feasible for 
conveying information about bottled water to customers. FDA agreed that 
bottled water should be labeled with contact information allowing 
consumers to more easily contact the manufacturer to obtain 
comprehensive information about the product, and said it intends to 
pursue this issue with bottled water manufacturers. 

Despite the concerns our report raised regarding FDA's regulation of 
bottled water under the FFDCA (particularly in comparison with EPA's 
regulation of drinking water under the Safe Drinking Water Act), we 
concluded that its observations must be viewed in the context of the 
legal limitations placed by the act on FDA, and the constrained 
resources that have affected FDA's overall capabilities in recent 
years. The legal limitations arise because while the Safe Drinking 
Water Act authorizes EPA to require water samples to be tested by 
certified laboratories, and violations of national primary drinking 
water regulations to be reported within certain time frames to EPA or 
the state agency with primary enforcement responsibility, the FFDCA 
does not grant FDA similar authority. Rather, the FFDCA requires FDA to 
regulate bottled water as a "food." As such, it does not specifically 
authorize FDA to require that bottled water be tested by certified 
laboratories or that violations of the standard of quality be reported 
to FDA. 

In addition to these legal constraints, bottled water's status as a 
food has subjected it to many of the same problems more generally 
affecting FDA oversight of food safety. As we noted in January 2007, 
[Footnote 6] for example, when we designated federal oversight of food 
safety as a "high-risk" area affecting public health and the economy, 
federal oversight of food safety is fragmented, with about 15 agencies 
having food safety roles. We specifically cited FDA's resource 
constraints, noting in 2008[Footnote 7] that while the number of 
domestic firms under FDA's jurisdiction increased from fiscal years 
2001 through 2007 from about 51,000 firms to more than 65,500, the 
number of firms inspected declined from 14,721 to 14,566 during the 
same period. We cited resource constraints as a contributing factor, 
noting that the number of full-time-equivalent positions at FDA devoted 
to food safety oversight had decreased by about 19 percent from fiscal 
years 2003 through 2007. 

Ultimately, as our January 2007 report recommended, a fundamental 
reexamination of the federal food safety system will be needed to look 
across the activities of individual programs within specific agencies 
with responsibilities related to food safety. Toward that end, we had 
previously recommended in 2001 that the Congress, among other things, 
enact comprehensive, uniform, and risk-based food safety legislation 
and commission the National Academy of Sciences or a blue-ribbon panel 
to analyze alternative organizational food safety structures in 
detail.[Footnote 8] We continue to believe that such a fundamental 
reexamination is needed, and believe that FDA's lack of authority and 
resources to effectively regulate bottled water should be part of it. 

Mr. Chairman, this concludes my statement. I would be pleased to 
respond to any questions you or other Members of the Subcommittee may 

Contacts and Acknowledgments: 

For questions about this statement, please contact John Stephenson at 
(202) 512-3841 or Individuals who made key 
contributions to this testimony include Steve Elstein, Assistant 
Director; Brian M. Friedman; Nathan A. Morris; Kelly A. Richburg; and 
Jeanette Soares. 

[End of section] 


[1] GAO, Bottled Water: FDA Safety and Consumer Protections Are Often 
Less Stringent Than Comparable EPA Protections for Tap Water, 
[hyperlink,] (Washington, D.C.: 
June 22, 2009). 

[2] A total of 83 unique bottled water labels were examined after 
removing duplicate labels, or labels that were not for bottled water. 
Labels were collected from GAO staff in each of our 11 field offices 
and at headquarters. 

[3] The two organizations are the American Beverage Association and the 
Container Recycling Institute. 

[4] P. H. Gleick and H. S. Cooley, Pacific Institute, "Energy 
Implications of Bottled Water," Environmental Research Letters, vol. 4, 
no. 014009 (2009). 

[5] Phthalates are a class of chemical compounds primarily used as a 
plasticizer, added to plastics to increase flexibility, transparency, 
durability, and longevity and found in a variety of food containers and 

[6] GAO, High-Risk Series: An Update, [hyperlink,] (Washington, D.C.: January 

[7] GAO, Food Labeling: FDA Needs to Better Leverage Resources, Improve 
Oversight, and Effectively Use Available Data to Help Consumers Select 
Healthy Foods, [hyperlink,] 
(Washington, D.C.: Sept. 9, 2008). 

[8] GAO, Food Safety and Security: Fundamental Changes Needed to Ensure 
Safe Food, [hyperlink,] 
(Washington, D.C.: Oct. 10, 2001). 

[End of section] 

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