FDA Reports on Feasibility of Tighter Bottled Water Labeling

April 1, 2000
The Food and Drug Administration (FDA) recently published its draft study on changes to bottled water labeling to comply with the Safe Drinking Water Act Amendments. The FDA has proposed that water bottlers provide additional water quality information to their customers. Although bottled water suppliers have contended this is unnecessary, an independent testing program examined 1,000 bottles of water and found that one-third had levels of bacteria in violation of EPA quality standards.

The Food and Drug Administration (FDA) recently published its draft study on changes to bottled water labeling to comply with the Safe Drinking Water Act Amendments. The FDA has proposed that water bottlers provide additional water quality information to their customers. Although bottled water suppliers have contended this is unnecessary, an independent testing program examined 1,000 bottles of water and found that one-third had levels of bacteria in violation of EPA quality standards.

The American Water Works Association (AWWA) on March 1 urged the FDA to require additional water quality information on bottled water labels. AWWA?s recommendation came in response to the bottled water industry?s claim that providing such information to consumers was unnecessary.

?Water suppliers have an obligation to produce safe, clean drinking water, whether it comes from a tap or a bottle,? said AWWA executive director Jack Hoffbuhr. ?Unfortunately, the public remains uninformed about bottled water quality, including what ? if any ? treatment water bottlers undertake before selling their product.?

During the past 15 years, personal bottled water consumption in the United States has risen more than 300 percent. In 1998, American consumers bought almost $5 billion worth of bottled water and purchases are expected to rise to $6.4 billion by 2003.

?Protecting public health demands full disclosure from drinking water suppliers, even if they supply their water in a bottle,? said Hoffbuhr. ?Water utilities already provide the public with easy access to drinking water quality information. The FDA is right to hold water bottlers to the same standard.?

Citing ?label clutter? the FDA said placing all water quality information on every bottle of water would not be practical. The agency also expressed concerns about the economic hardship to water bottlers caused by reprinting labels to reflect changing analytical data.

NRDC recently completed a four-year study of the bottled water industry, including its bacterial and chemical contamination problems.

?About one-third of the bottled waters we tested contained significant contamination (i.e., levels of chemical or bacterial contaminants exceeding those allowed under a state or industry standard or guideline) in at least one test ?? the NRDC reported. ?In sum, approximately one third of the tested waters (34 of 103 waters, or 33 percent) violated an enforceable state standard or exceeded microbiological-purity guidelines, or both, in at least one sample.?

Where EPA can enforce any violation of its standards, FDA allows bottled water in violation of standards to be sold if labeled as ?containing excessive chemicals? or ?excessive bacteria.? Under federal law, any packaged or bottled foodstuff is considered a food and falls under the purview of the FDA. This technicality allows water bottlers to meet less rigorous testing, treatment and public notification regulations than the Environmental Protection Agency (EPA) demands of community water suppliers. Unlike water utilities, water bottlers are not currently required to actively inform the public about the quality of the water they bottle.

?No one should assume that just because he or she purchases water in a bottle that it is necessarily any better regulated, purer, or safer than most tap water....,? NRDC said in its petition to the FDA. ?If bottled water is so pure, why not prove it with full disclosure on the label??

Finding what it calls ?major regulatory gaps,?, NRDC points out that FDA rules exempt 60 to 70 percent of the bottled water, that which is sold within the same state. As well, the FDA rules exempt ?carbonated water,? ?seltzer,? and others from its bottled water standards.

NRDC determined that FDAs specific bottled water rules are weaker than EPA rules for tap water. Water bottlers do not have any operator certification or training requirements to ensure they know how to safely treat and deliver water. FDA does not prohibit confirmed E. coli or fecal coliform bacteria, but allows a certain amount of any type of coliform bacteria. No federal filtration or disinfection requirements exist for bottled water, and NRDC found many states have failed to adopt standards. Water bottlers must conduct tests for coliform bacteria only on a weekly basis, and they do not have to test for Cryptosporidium or Giardia.

As for chemical contamination, NRDC found that water bottlers generally must test only annually, and FDA rules do not require certified testing or mandatory reporting. FDA exempted bottled water from standards limiting chemicals like phthalate, which leaches from plastic bottles.

The Safe Drinking Water Act Amendments of 1996 required the Food and Drug Administration (FDA) to conduct the feasibility study it published in the February 22 Federal Register. Recognizing that currently required nutrition labeling falls far short of the information required for consumer confidence reports (CCR), FDA back in 1997 requested comments about what types of contents information should be provided to consumers.

The issue does not appear to be whether water bottlers should provide consumers with more content information, but instead appears to be how much more and the manner in which consumers will receive the information.

The FDA has requested comments on water bottle labeling. The agency will issue a final report after it has time to review the responses from this second round of comments. The comment period closes April 24, 2000, and written comments should be received by then at the Dockets Management Branch, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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