Tuesday, February 01, 2005

NRDC: Bottled Water: Pure Drink or Pure Hype?

NRDC: Bottled Water: Pure Drink or Pure Hype?: "Bottled Water
Pure Drink or Pure Hype? "

PRINCIPAL FINDINGS AND RECOMMENDATIONS
Americans increasingly are turning to bottled water, making it a $4 billion-a-year business in the United States. [1] Millions of us are willing to pay 240 to over 10,000 times more per gallon for bottled water than we do for tap water -- though we probably rarely think of it that way. [2] However, some bottled water contains bacterial contaminants, and several brands of bottled water contain synthetic organic chemicals (such as industrial solvents, chemicals from plastic, or trihalomethanes -- the by-products of the chemical reaction between chlorine and organic matter in water) or inorganic contaminants (such as arsenic, a known carcinogen) in at least some bottles (see Chapter 3 and our accompanying Technical Report [print report only]).[1a] Moreover, as Chapter 4 documents, bottled water regulations have gaping holes, and both state and federal bottled water regulatory programs are severely underfunded. In Chapter 5 we present evidence that there is substantially misleading marketing of some bottled water, and in Chapter 6 we argue that consumers should be informed about the contaminants found in the water they purchase. NRDC's major findings and recommendations are summarized below.




Findings
1. Most bottled water apparently is of good quality, but some contains contamination; it should not automatically be assumed to be purer or safer than most tap water.
Based on available data and our testing, most bottled water is of good quality, and contamination posing immediate risks to healthy people is rare (see Chapter 3 and the Technical Report [print report only]). However, blanket reassurances from the bottled water industry that bottled water is totally safe and pure are false.

No one should assume that just because water comes from a bottle that it is necessarily any purer or safer than most tap water. Testing commissioned by NRDC and studies by previous investigators[3] show that bottled water is sometimes contaminated. NRDC contracted with three leading independent laboratories to do "snapshot" testing (testing one to three times for a subset of contaminants of concern) of bottled water.

We found after testing more than 1,000 bottles that about one fourth of the bottled water brands (23 of 103 waters, or 22 percent) were contaminated at levels violating strict enforceable state (California) limits for the state in which they were purchased, in at least one sample. We also found that almost one fifth of the waters we tested (18 of 103, or 17 percent) exceeded unenforceable sanitary guidelines for microbiological purity (heterotrophic-plate-count [HPC] bacteria guidelines, adopted in some states, the European Union (EU), and recommended by the bottled water industry) in at least one test. While HPC bacteria may be harmless themselves, they may mask the presence of pathogens; some states, the EU and the bottled water industry have adopted HPC guidelines to help ensure sanitary source water, processing, and bottling practices. In all, at least one sample of one third of the waters we tested (34 of 103, or 33 percent) exceeded a state enforceable standard for bacterial or chemical contamination, a nonenforceable microbiological-purity (HPC) guideline, or both.

The labs contracted by NRDC detected contaminants of potential concern (either microbes or chemicals regulated in tap or bottled water) in at least one sample of about half of the bottled waters we tested, though in the majority of the waters no standards were exceeded. While state or industry standards and guidelines were violated in at least one test for about one fourth of the bottled waters, just four waters (4 percent) exceeded the weak federal standards. Of these four waters, two violated the FDA coliform-bacteria rule (coliforms are bacteria that can be harmless themselves but may indicate the presence of fecal contamination and disease-carrying organisms in the water) in one test. When we retested another lot of the same waters for coliform bacteria, however, both of these waters tested clean. In addition, two other waters violated the FDA standard for fluoride in two sequential tests of samples from different lots of these two waters.

While our testing is the most comprehensive publicly available independent testing of U.S. bottled water, it must be viewed as incomplete. Only about half of the drinking water contaminants regulated by FDA and EPA were tested, due to cost constraints. There are, conservatively, more than 700 brands selling bottled water in the United States, yet we tested only 103 waters. Additionally, we generally tested just one to three lots of each water, whereas often thousands or even millions of bottles may be produced annually by a single bottler, with the potential for periodic (and undetected) contamination problems. Testing by other investigators generally has been consistent with our results. For example, as is discussed in detail in the accompanying Technical Report (print report only), a major survey of microbiological contamination of domestic and imported bottled water sold in Canada published in 1998 yielded results very similar to NRDC's. [4] We were not able to test for Cryptosporidium in bottled water (nor did the Canadian investigators) because the current EPA method for Cryptosporidium monitoring requires the filtration of many gallons of water and analysis of the filter using a method feasible for bottlers prior to bottling the water, but this was logistically and financially infeasible for us to use on finished product sold at stores.

Bottled water recalls and other contamination incidents -- whether bacterial, industrial-chemical, algae, excessive-chlorine, or other contamination problems -- have sometimes been quietly dealt with by bottlers, generally with little or no public fanfare. In other cases, violations of bottled water standards have been allowed to go on for months without a recall or formal enforcement action. Although most of the bottled water on the market seems to be of good quality, some of these products are not as absolutely pure and pristine as many of their consumers may expect.

Comparing the data for bottled water quality with those for tap water is not straightforward. Far more monitoring data are publicly available for tap water than for bottled water. EPA requires frequent monitoring of tap water and makes available on its Web site national compliance data for all tap water systems. [5] Additionally, numerous surveys of tap water quality (beyond simple compliance data) are available for tap water quality, [6] whereas no such comprehensive data are available for bottled water. Thus, direct comparison of tap water quality versus bottled water quality is not possible based on comparable databases. However, EPA recently reported that in 1996, almost 10 percent of community tap water systems (serving 14 percent of the U.S. population) violated federal EPA tap water treatment or contaminant standards, and 28 percent of these tap water systems violated significant water quality monitoring or reporting requirements. [7] While these tap water system compliance data are plagued by underreporting and likely understate the extent of the problem somewhat, [8] without question they are based on a far larger database than is publicly available for bottled water. Moreover, according to available data, nearly half of the U.S. population served by tap water systems gets legally allowable but from a health standpoint potentially significant levels of contaminants such as cancer-causing trihalomethanes, radon, and/or arsenic in their tap water. [9] Thus, while there definitely are problems with a substantial minority of the nation's tap water systems, based on the limited data available there is little basis to conclude that just because water is purchased in a bottle it is necessarily any better than most tap water.




2. Bottled water contamination with microbes may raise public health issues, particularly for people who are immunocompromised.
Millions of Americans use bottled water as their primary source of drinking water. Some of these people are immunocompromised (such as people undergoing cancer chemotherapy, organ-transplant recipients, the chronically ill elderly, some infants whose immune systems are not fully developed, and people with AIDS) and use bottled water at the recommendation of public health officials or health care providers, who suggest that tap water use may be too risky.[1b] In some cases, officials also may urge the general public to use bottled water during a tap water contamination crisis.

As discussed in Chapter 3 and our attached Technical Report (print report only), NRDC's testing and other published and unpublished data indicate that while most bottled water apparently is of high quality in terms of microbiological purity, a substantial minority of it may not be. As noted there, a small percentage of the bottled water we tested (about 3 percent) sometimes contained coliform bacteria -- a possible indicator of contamination with pathogenic bacteria -- and nearly one fifth of the waters we tested contained heterotrophic-plate-count (HPC) bacteria at levels exceeding state and industry guidelines in at least one test. Some bottled waters contain bacteria (sometimes naturally occurring), including species of Pseudomonas and others, some of which may be a health concern for immunocompromised people. [10]

In cases where there is known tap water microbial contamination, or where an individual suffers from specific health problems such as a compromised immune system, tap water can be boiled for one minute to kill all microbes. In the alternative, certain types of bottled water may be a temporary solution. To be cautious, however, an immunocompromised person should buy bottled water only if it is from a protected source, and is subjected to EPA-CDC-recommended treatment to kill Cryptosporidium, the intestinal parasite that sickened over 400,000 people and killed over 100 in a 1993 Milwaukee tap water incident. [11] For example, to remove or kill Cryptosporidium, water must be treated with "absolute one micron" membrane filtration or reverse osmosis, adequately high levels of ozone disinfection, or distillation, at a minimum.

Thus, NRDC recommends that seriously immunocompromised people boil their tap water for one minute before using it for consumption or washing food. If they choose to buy bottled water, they should consider purchasing only certified "sterile" bottled water. Most bottled water has not been independently certified to meet either the EPA-CDC standards for killing Cryptosporidium or the definition of "sterile" water, so vulnerable people must be especially careful in selecting a drinking water supply.[1c]




3. Government bottled water regulations and programs have serious deficiencies.
Chapter 4 outlines in detail the gaping holes in federal regulatory controls for bottled water, and the trivial FDA resources dedicated to protecting bottled water. FDA estimates that one half of a full-time FDA staff person is dedicated to bottled water regulation, and fewer than one FDA staff-person equivalent is spent on assuring compliance with FDA bottled water rules. [12] An estimated 60 to 70 percent of the bottled water sold in the United States, according to FDA interpretations, is exempted from FDA's contamination limits and specific bottled water standards because it is bottled and sold in the same state.

Thus, under FDA's interpretation, the regulation of most bottled water is left to ill-equipped and understaffed state governments. Yet 43 of 50 states have the equivalent of fewer than a single staff person dedicated to regulating bottled water, according to our 1998 state survey. Four states have adopted no regulations at all for bottled water, and the majority of states have simply republished FDA's deficient rules. About 40 states say they regulate "intrastate" waters, but most have dedicated virtually no resources to doing so.

FDA's rules also exempt many forms of what most of us would consider "bottled water" from all of its specific water-testing and contamination standards. If the product is declared on the ingredient label simply as "water," "carbonated water," "disinfected water," "filtered water," "seltzer water," "sparkling water," or "soda water," it is not considered "bottled water" by FDA, [13] nor, as noted in Chapter 4, do most states regulate this water as bottled water. For these products, the specific FDA contamination standards and water quality testing requirements for bottled water are not applicable. No contamination monitoring is required, and only a vague narrative legal standard applies, stating that the water cannot be "adulterated" -- a term not specifically defined and, to date, apparently never enforced against any of these products by FDA. Therefore, the generalized FDA "good manufacturing practice" requirements applicable to these waters[14] set no specific contamination standards. The same is true with most state regulations.

Even what FDA defines to be "bottled water" is exempt from many of the standards and testing requirements that apply to tap water. This appears to directly contradict the letter and the spirit of the Federal Food, Drug, and Cosmetic Act (FFDCA), which requires -- under a provision strengthened in 1996 -- that FDA's bottled water standards must be at least as stringent as tap water standards. [15] For example, EPA's rules clearly prohibit tap water from containing any confirmed E. coli or fecal coliform bacteria (bacteria that are indicators of possible fecal matter contamination often associated with waterborne disease). [16] FDA has no such prohibition for bottled water; instead, any type of coliform bacteria is allowed up to a certain level. [17] (See Table 1 for a comparison of EPA and FDA rules.)

Similarly, a big city has to test its tap water 100 times or more each month for coliform bacteria -- many times a day, on average -- yet bottled water (even at an enormous bottling plant) must be tested for coliform bacteria only once a week under FDA rules. Moreover, while high overall levels of bacteria (known as heterotrophic-plate-count [HPC] bacteria) can be counted toward bacteria violations for city tap water (in the absence of adequate disinfection), as described in Chapter 4, FDA bowed to bottled water industry arguments and decided to apply no standards for HPC bacteria in bottled water. HPC bacteria are commonly found in bottled water.

EPA's "information collection rule" generally requires big cities that use surface water (such as rivers or lakes) for tap water to test for common parasites such as viruses, Giardia, and Cryptosporidium. Under FDA rules, water bottlers are never required to do so. In the same vein, cities using surface water generally must disinfect their water and filter it to remove bacteria and certain parasites.[1d] Yet there are no FDA standards requiring bottled water to be disinfected or treated in any way to remove bacteria or parasites. Additionally, the FDA requirement that bottled water be derived from an "approved source" is no substitute for source water protection, filtration, or disinfection. This rule has been aptly characterized as a "regulatory mirage," since what is "approved" is left to state discretion with no meaningful federal requirements or oversight.

For chemical contaminants, the regulations for bottled water are also weak in many ways. While a city generally must test its tap water for scores of organic chemicals (such as industrial chemicals, some pesticides, and trihalomethanes) at least quarterly,[1e] bottlers generally need only test once a year under FDA's rules. These infrequent annual tests could miss serious problems, because levels of these contaminants sometimes vary substantially depending on when they are tested.

Also, phthalate[1f] -- a toxic chemical produced in plastic-making that tests show can leach from plastic into water under common conditions -- is regulated by EPA in tap water but FDA does not regulate it in bottled water. After some water bottlers and plastics manufacturers argued that phthalate controls would be inappropriate and burdensome for bottled water, FDA decided not to regulate it in bottled water, where it is sometimes found, particularly after long storage.

Furthermore, FDA currently has no enforceable standard or treatment requirement for three other contaminants regulated by EPA in tap water -- acrylamide, asbestos, and epichlorohydrin. Thus, while city water systems generally must test for all of these contaminants and must meet EPA standards for them, presently water bottlers need not.

EPA also requires city tap water suppliers to test for more than a dozen "unregulated" contaminants -- chemicals that are not currently subject to EPA standards but which, if present, may pose a health concern, such as a risk of cancer. Under EPA rules, states are to consider adding 15 additional named unregulated contaminants to this list for mandatory water system monitoring, if they are believed to be a potential problem in local tap water. [18] Bottlers face no monitoring requirements for any unregulated contaminants.

Even if bottled water is more contaminated than FDA's standards would otherwise allow, FDA rules explicitly allow the water to be sold, as long as it says on the label "contains excessive chemical substances" or "contains excessive bacteria" or includes a similar statement on the label. FDA says it may enforce against such labeled contaminated water if it finds that it is "adulterated" and "injurious to health." However, there is no requirement that water bottlers report such problems to FDA, and apparently there are no cases of FDA having taken any enforcement action against any such bottlers.

FDA has stated that bottled water regulation carries a low priority. [19] Because of this, water bottlers can expect to be FDA-inspected only about every four to five years, on average. [20] This is far too infrequent to detect certain possible problems, such as periodic contamination caused by occasional substandard plant operations or maintenance, bacteria from sewage overflows or leaks, pest infestations, or occasional spikes of pollution due to short-lived phenomena. In addition, bottlers are not required to keep records of their operations and testing for more than two years, making effective inspections difficult or impossible, since evidence of periodic or past problems can simply be discarded before it is ever reviewed by inspectors.

It also should be noted than in many cases FDA's rules are weaker than international standards. The European Union's (EU's) bottled water standards, for example, set limits for total bacteria count, [21] which, as noted above, FDA does not. Moreover, the EU's bottled mineral water rules ban all parasites and pathogenic microorganisms, E. coli or other coliform bacteria, fecal streptococci (e.g., Streptococcus faecalis, recently renamed Enterococcus faecalis), Pseudomonas aeruginosa, or sporulated sulphite-reducing anaerobes, whereas FDA's rules include no such bans. [22] Additionally, unlike the FDA rules, EU rules require natural mineral water's labels to state the waters' "analytical composition, giving its characteristic constituents" and the specific water source and name, and information on certain treatments used. [23] The EU mineral water rules further forbid use of more than one brand label per source of water[24] and generally prohibit labels from making any claims about the prevention, treatment or cure of human illness. [25] No such provisions are included in FDA rules. Similarly, the EU’s new general standards for all bottled water generally are far stricter than FDA’s rules, and FDA's standards for certain chemicals (such as arsenic) are weaker than World Health Organization (WHO) guidelines for drinking water. [26]




4. Voluntary bottled water industry controls are commendable, but an inadequate substitute for strong government rules and programs.
The bottled water industry's trade association, the International Bottled Water Association (IBWA), has sometimes been a progressive force in seeking to improve certain FDA controls (petitioning for stronger FDA rules in some areas, for example). Moreover, IBWA has adopted a voluntary state bottled water code -- somewhat stricter than the FDA rules -- which has been adopted in whole or in part by 16 states. However, IBWA sometimes has vigorously fought against tough FDA rules, such as possible controls on Pseudomonas aeruginosa bacteria, rules for heterotrophic bacteria, and right-to-know requirements for bottled water. The fight against right-to-know for bottled water is interesting in light of the bottled water industry's frequent references to tap water contamination problems. It also starkly contrasts with IBWA's admission that bottled water sales may have increased due to the requirement that diet soda labels disclose all ingredients, which IBWA said may have driven consumers concerned about diet soda's contents to use bottled water. [27]

IBWA has adopted a much-ballyhooed voluntary industry code and inspection program for its members. The association claims its members produce 85 percent of the bottled water sold in the United States. [28] But these voluntary IBWA standards are just that -- voluntary -- in the 34 states that have not adopted them, and there is no published reporting about compliance. Additionally, IBWA does not disclose the results of its inspections and testing to the public, so it is impossible to verify independently the effectiveness of these voluntary programs. Moreover, even by IBWA's count, many bottlers are not IBWA members and have never volunteered to comply with the association's standards. In fact, some of the problems with some bottled waters discussed in this report have occurred with IBWA members, suggesting the IBWA program is not foolproof. Finally, it should be noted that, as with FDA rules, IBWA standards do not apply to seltzer, soda water, carbonated water, or the many other waters exempt from FDA's bottled water rules. [29]




5. Bottled water marketing can be misleading.
Chapter 5 shows that despite recent FDA rules intended to reduce misleading marketing, some bottled water comes from sources that are vastly different from what the labels might lead consumers to believe. One brand of water discussed in this report was sold as "spring water" and its label showed a lake and mountains in the background -- with FDA's explicit blessing. But until recently the water actually came from a periodically contaminated well in an industrial facility's parking lot, near a waste dump (a state whistleblower informed the local media after years of internal struggles, finally putting an end to the use of this source).[30] Another brand of water sold with a label stating it is "pure glacier water" actually came from a public water supply, according to state records.[31] While FDA recently adopted rules intended to curb such practices, those rules include many weak spots and loopholes (including those that allowed the water taken from an industrial-park well to be sold as spring water with a label picturing mountains), and there are very few resources to enforce them.

Water with one brand name can come from numerous different sources, depending upon the time of year, location of sale, or other market factors. Moreover, water from one source (such as the industrial-parking-lot well noted above) can be used and labeled for a half-dozen or more different labels and brands. In addition, according to government and industry estimates, about one fourth or more of the bottled water sold in the United States [32] (and by some accounts 40 percent[33]) is taken from public water systems -- tap water, essentially. Sometimes this tap water is bottled after additional treatment (such as carbon filtration or ozonation), and sometimes it is bottled with little or no additional treatment.




6. The long-term solution to drinking water problems is to fix tap water -- not to switch to bottled water.

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