The quality of drinking water in the United States (U.S.) is extensively monitored and regulated by federal, state and local agencies, yet there is increasing public concern and confusion about the safety and quality of drinking water –– both from public water systems and from bottled water products. In the U.S., tap water and bottled water are regulated by two different agencies: the Environmental Protection Agency (EPA) regulates public water system water (tap water) and the Food and Drug Administration (FDA) regulates bottled water. Federal law requires that the FDA’s regulations for bottled water must be at least as protective of public health as EPA standards for tap water .
The quantity of publically supplied water which is directly consumed as drinking water is estimated by the American Water Works Association to be less than four tenths of one percent (<0.4%) of the total produced . As a food product, however, 100% of bottled water is intended for human consumption.
With respect to public water supplies, researchers estimate that more than 500 boil alerts occurred in the United States in 2010 . In addition, the Centers for Disease Control and Prevention (CDC) reports that waterborne diseases, such as Cryptosporidiosis and Giardiasis, cost the U.S. healthcare system as much as $539 million a year in hospital expenses . In 2006, EPA researchers reported an estimated 16.4 million cases of acute gastrointestinal illness per year are caused by tap water . Subsequent research has estimated that the number of illnesses to be closer to 19.5 million cases per year .
In contrast, a survey of state bottled water regulatory authorities, dated June, 2009 and conducted by the Government Accountability Office (GAO), found there were zero outbreaks of foodborne illness from bottled water over a 5-year period. Moreover, in testimony before a July 9, 2009 Congressional hearing, a FDA official stated that the agency was aware of no major outbreaks of illness or serious safety concerns associated with bottled water in the past decade . In addition, a review of the FDA’s recall database reveals that only two Class I recalls of bottled water products have occurred since 1990. The first, occurring in Puerto Rico in June, 1990, was a recall of isopropyl alcohol that was labeled as “distilled water.” The second recall, in 2007, involved five Armenian mineral water products imported into the U.S. with excessive arsenic levels, as discovered by testing completed by the FDA.
Drinking water experts have begun turning their attention to the distribution systems that carry the EPA-regulated public system drinking water from treatment plants to consumers. Emerging research has found that microbial issues in distribution systems are causing significant waterborne illness outbreaks, and that the outbreak incidence has been steadily increasing since the late 1980s .
The purpose of this review and position paper is to help educate the public about the importance of access to safe drinking water and inform policy makers and the general public about issues such as water distribution systems, infrastructure repair, safe water availability, and the EPA’s regulation of public water systems for microbial contaminants and how this compares with the FDA’s regulation of bottled water. All of these topics combined are potentially major contributing factors to impending health concerns and risks related to drinking water in the United States.
2. Comparison of regulations, standards, monitoring and advisories
Public drinking water and bottled water are both regulated extensively. These regulations include an array of international, federal, state, and local agencies, and in some cases, trade associations. There are health-based standards for both tap and bottled waters, and these standards are, with few exceptions, the same .
Unlike tap water compliance failures, which generally result in monetary fines and requirements for corrective action, under the Park Doctrine, the failure of a bottled water product to meet the FDA Standards of Quality can result in criminal liability for the responsible person(s) in the manufacture and distribution of a food product that causes adverse health consequences to the public .
There are notable differences in standards for microbiological contaminants between bottled water and tap water. With the promulgation of the FDA’s “Bottled Water Microbial Rule,” effective December 1, 2009, bottled water now has standards specifically regulating total coliform (TC) and Escherichia coli (E. coli) in both non-Public Water System (PWS) source water and all finished product water. There are specific requirements for follow-up monitoring in the event of a positive test result for total coliform, i.e., each positive TC result must be evaluated for presence of E. coli. The FDA Rule also makes clear that:
If E. coli is detected and confirmed in non-PWS source water, that source water is not of a safe and sanitary quality for bottling, and must not be used as a source for bottled water. If that water is used for bottling, the finished product is considered by the FDA to be adulterated.
If E. coli is detected and confirmed in finished product water at any level, that product is also deemed adulterated under provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA).
The EPA currently has no enforceable standard for either total coliform or E. coli in source waters. Under the EPA Groundwater Rule (GWR), groundwater-sourced PWSs must engage in additional source water testing and implement a sanitary survey, specified levels of treatment, and other corrective actions, but the source is not removed from service. However, the U.S. EPA published the revised Total Coliform Rule (rTCR) as a final rule on February 13, 2013. Although not yet promulgated, the Rule will affirm a new standard for E. coli in public drinking water, and will also require an investigation and corrective action at groundwater sources that test positive for E. coli. The revised TCR removes the standard for total coliform, while the FDA continues to regulate bottled water for both total coliform and E. coli.
With regard to response when a microbial standard is exceeded, bottled water compliance is determined from each individual test result in both the source and the finished product. When one sample exceeds the standard of quality for E. coli, and the bottler continues to use the source for bottling, the finished product is considered by the FDA to be adulterated and subject to recall. The FDA also clearly stated its policy on adulterated finished product in the 2009 Bottled Water Microbial Rule.
“If E. coli is present in bottled water, then the bottled water is deemed to be adulterated under section 402(a)(3) of the act (§ 165.110(b)(2)(i)(B); § 165.110(d)).” 74 Fed. Reg. 25651 (May 29, 2009)
Public water systems are currently required to collect a specified number of samples per month, as is discussed in the monitoring section. The current EPA TCR maximum contaminant level (MCL) for total coliform is “no more than 5% of monthly samples are valid for total coliform.” For example, if a small groundwater-sourced community water system collects only the required minimum of 25 samples per month, one of those samples may test positive for total coliform, but the system would be in compliance with the TCR. The TCR requires positive test results for total coliform to be confirmed for presence of E. coli. If any of the coliform samples are positive for E. coli, a public notification, usually with a boil water order, is issued to consumers. The new USEPA revised Total Coliform Rule will require public notification only for E. coli when it becomes effective (date to be determined).
The comparison of microbiological standards for bottled water and tap water is presented in the table.
In addition, the EPA has established a guideline for heterotrophic plate count (HPC) bacteria of 500 CFU/ml as a means of demonstrating adequate levels of disinfection in the distribution system. This is not a health-based standard, and it is only used to indicate adequate disinfection in the distribution system. There are no standards or guidelines for HPC in bottled water. However, in 2002, the World Health Organization published a report on HPC bacteria in drinking water, concluding that “The available body of evidence supports the conclusion that, in the absence of fecal contamination, there is no direct relationship between HPC values in ingested water and human health effects in the population at large.” Therefore, the HPC bacteria found in natural bottled waters is considered to be part of the natural flora of the water, and does not pose a health risk in the absence of fecal indicators such as E. coli . Although HPC is not an FDA-required test for bottled water, most bottled water companies currently, or will, under upcoming rules from the Food Safety Modernization Act (FSMA), monitor for HPC as part of their ongoing internal sanitation control and environmental monitoring programs.
In addition, as Messner, et.al. (2006) notes, pathogens have a wide range of resistance to public water system disinfection and Cryptosporidium is the most resistant. “Free chlorine, the most commonly used disinfectant, achieves virtually no inactivation of Cryptosporidium but appears very effective for inactivating most viruses .” The FDA permits only the use of ground water not under the direct influence of surface water, as defined in 21 C.F.R. §141.2, as source water for bottling. Exclusion of such source waters also precluded the need to regulate bottled water for surface water parasites like Cryptosporidium parvum and Giardia lamblia.
It is in the area of monitoring activities that tap water and bottled water truly diverge. One major reason for this divergence is the method of delivery. Tap water is delivered to consumers through systems of underground piping, while bottled water is packaged in a sealed container and delivered to consumers through retail outlets and home delivery.
2.4. EPA monitoring requirements — Microbiological testing frequencies
Testing frequency for total coliform at groundwater and surface water-sourced Community Water Systems (CWSs) is based primarily on the population served. The number of samples required is prescribed on a monthly schedule. Therefore, a CWS will collect a minimum of anywhere from 1 up to 480 samples per month. The following table, which lists the number of samples to be tested, is taken from 40 CFR 141:
CWS Monitoring schedule for total coliform (From the USEPA RTCR) 
2.5. FDA monitoring requirements
Bottled water sources (other than municipal water sources) are required to be tested for total coliform weekly at each source used for bottling. If any source water sample is positive for total coliform, the FDA requires that it be evaluated for presence of E. coli. If a sample is confirmed to be contaminated with E. coli, the source is considered not suitable for bottling, and any product that contains water from that source is considered by the FDA to be adulterated.
Each bottled water finished product type (spring water, purified water, fluoridated water, etc.) is required to be tested for total coliform weekly. If any product sample is positive for total coliform, the FDA requires that it be evaluated for presence of E. coli. If a sample is confirmed to be contaminated with E. coli, the product type is considered by the FDA to be adulterated.
To fully understand a comparison of bottled water testing and public water system testing, one must look at the relative size of the operations and the amount of water processed by each. The FDA states in the preamble to their March 3, 2003 direct final rule for radionuclides that they base sample frequency on the following:
“According to EPA’s per capita total water use estimates applied to bottled water, an average bottled water facility processes as much water as a municipal system serving between 42 and 72 households… serving between 100 and 500 people, which is the closest category EPA presents.”
Applying this principle, a community water system serving between 100 and 500 people is required by the USEPA to test a minimum of one (1) total coliform sample per month. The FDA requires one (1) total coliform sample per week.
2.6. Comparisons of bottled water plant testing and PWS testing for total coliform
For more direct comparison of bottled water and public water testing, here are examples of each for total coliform.
In the table below, a large bottled water plant packaging approximately 250,000 gallons per day is compared to New York City, which, according to 2009 data, distributed approximately 1.086 billion gallons of water per day within its distribution system.
As the table above shows, even though New York City is required to collect a minimum of 480 samples per month, when those samples are viewed on a gallons of water produced basis, the bottled water plant tests 36 times more frequently than the New York City system. Of course, this assumes only the minimum number of samples required by the FDA and the EPA is collected. In all likelihood, both the bottled water plant and New York City are collecting more than the minimum number of samples.
Below is a comparison of large bottled water plant with a smaller public water system – the groundwater-based CWS serving 10,000 that was reviewed earlier in this paper:
The Table below compares a small home and office delivery (HOD) bottled water plant with the CWS serving 10,000 people.
The ratio of bottled water samples tested versus the number of CWS samples tested is up to 19:1. Once again, this assumes both the bottled water plant and the community water system are collecting only the minimum number of samples required by their respective regulations.
3.1. When public drinking water does not meet EPA standards — Advisories
Public water systems must notify the public when they violate EPA or state drinking water regulations (including monitoring requirements) in cases when the drinking water may pose a risk to consumer’s health . Under the EPA notification rule, there are three tiers of notification, depending on the seriousness of the violation. The table below shows how public system drinking water violations are assessed.
The EPA reports that in 2011, 93.2 percent of US public water systems met health-based standards for drinking water. Also in that year, the EPA reports US public water systems had 8,431 total coliform rule violations affecting 9,837,344 people .
3.2. When bottled water does not meet FDA standards — Advisories
Under FDA rule (21 C.F.R.§165.110), bottled water that “contains a substance at a level considered injurious to health under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the act), or that consists in whole or in part of any filthy, putrid or decomposed substance, or that is otherwise unfit for food under section 402(a)(3) of the act is deemed to be adulterated, regardless of whether or not the water bears a label statement of substandard quality prescribed by paragraph (c) of this section. If E. coli is present in bottled water, then the bottled water will be deemed adulterated under section 402(a)(3) of the act .” Adulterated food and beverages should not enter the food supply, and if they do, the manufacturer could face criminal or civil penalties and mandatory recalls. Criminal penalties could be assessed under the Park Doctrine, which places responsibility for adulterated product on company owners and/or senior management.
The FDA’s website recall database indicates that in 2011 and 2012 there was one incidence of a bottled water Class II recall . Mountain Pure, LLC voluntarily recalled 23,000 16.9 oz. bottles of its Mountain Pure bottled water in Clinton, AR on May 4, 2011 because of a biological contamination. In a FDA press release, the Arkansas Department of Health said it was unlikely that a healthy person would get sick from drinking the water, but people with a weakened immune system might be at higher risk . In 2014, in Pittsburgh there was precautionary voluntary recall of bottled water because of a preliminary finding of E. coli in a finished product. All confirmatory tests performed in a number of certified laboratories were negative for both E. coli and total coliforms. These negative findings plus the high ozone concentration used in bottled waters in Pennsylvania (plus the bottling plan in additions uses ultraviolet light) makes this finding of E. coli without any merit.
3.3. People who have immune-compromised illnesses
Waterborne diseases can lead to serious acute, chronic and sometimes fatal health consequences, especially for people who have compromised immune systems. Both the CDC and the EPA advise people who have immune-compromised illnesses (such as people undergoing chemotherapy, living with HIV/AIDS, transplant patients, children and infants, elderly and pregnant women) to consider taking extra precautions with their drinking water . An EPA video and accompanying booklet aimed at educating health care providers about drinking water tells providers to advise these patients to “to consider alternatives to tap water .”
4. Comparison of estimated incidences of public water system-borne and bottled waterborne diseases
4.1. EPA approach to a national estimate
Research into drinking water-related incidences of acute gastrointestinal illness (AGI) is sparse largely due to gaps in data caused by reporting uncertainties. However, the EPA has developed an analytical approach and model for generating a national estimate of AGI illness due to drinking water and using this model, it is estimated that public water systems cause 16.4 million cases of AGI per year in the United States .
A Messner, et al. (2006) study uses AGI to measure public water system health risk because AGI is the broadest indicator of health effects associated with most water-borne pathogens and allows for comparison to national data on AGI incidence due to all causes. His study focuses on public water systems because 94% of the US population lives in a community that is served by public water systems. He acknowledges that water-borne diseases caused by non-public water systems could be significant, but a lack of data makes it difficult to include non-public water systems in calculating a national estimate.
In his research, Messner, et al. (2006) cites a Laval household intervention study that shows significant differences in Highly Credible Gastrointestinal Illness (HCGI) incidences between tap water drinkers and bottled water drinkers. “The difference in incidence between the two groups of 0.26 cases of HCGI per person-year represents the estimated attributable risk to drinking tap water .”
Meanwhile, a much broader study by Reynolds, et al. (2008) calculated all possible water-borne infections and illnesses associated with exposure to pathogens in drinking water, not just AGI, and concluded the estimated number of water-borne illnesses per year in the US is 19.5 million cases .
5. Outbreaks associated with bottled water
The FDA testified before a United States House of Representatives Subcommittee on Oversight and Investigations in July 2009 that the agency was aware of no major outbreaks of illness or serious safety concerns associated with bottled water in the past decade . And said: “Because FDA's experience over the years has shown that bottled water has a good safety record, bottled water plants generally are assigned a relatively low priority for inspection.”
At that same hearing, the Government Accountability Office (GAO) made public its report on bottled water, which found that based on a survey of water quality or food and health protection officials in all 50 states and the District of Columbia, there was no evidence that bottled water caused any illnesses during the previous five years .
Meanwhile, the CDC attributes just five cases of AGI to bottled water in the past 10 years . (One case of AGI in 2007 caused by an unidentified agent, one case of AGI in 2004 caused by gasoline byproducts, and three cases of AGI in 2003 caused by the chemical bromate, unidentified chemical cleaning product, and unidentified agent.)
5.1. Outbreak comparison
The following table summarizes the estimated incidences of Public Water System-borne and Bottled Waterborne diseases.
6. Distribution system and contact surface comparisons
EPA-mandated protocols are designed to effectively eliminate pathogens from public water system drinking water, but treatment inadequacies and interruptions, as well as public drinking water distribution system failures, have been associated with waterborne disease outbreaks . In fact, recent research indicates distribution system failures are increasingly the cause of waterborne outbreaks .
The pipes that connect treatment plants to consumers’ taps span 1 billion miles in the United States . Researchers studying public health risks associated with contamination occurring in public water supply distribution systems have found a list of probable causes including: cross connections and backflow, intrusion caused by pressure transients, nitrification, permeation and leaching, water main repair and replacement, aging infrastructure and microbial growth inside distribution pipes .
6.1. Number of outbreaks caused by public water supply distribution systems
Data from the CDC’s passive drinking water surveillance system indicates the incidence of public water supply waterborne disease outbreaks has actually decreased since the 1980s, presumably due to the EPA’s Surface Water Treatment Rule and the Total Coliform Rule. However, the number of outbreaks due to public water supply distribution system issues and failures has remained relatively consistent despite an apparent increase in the percentage of those outbreaks (see chart below). It is also the case that if contamination occurs but only affects a small number of people, it may not be reported and investigated as an outbreak. “Indeed, it has been acknowledged that a fairly sizable number of cases of cryptosporidiosis could be occurring in a large city such as New York City without detection of a possible outbreak .”
Source: “Public Water Supply Distribution Systems: Assessing and reducing risks,” National Academy of Sciences, 2005.
In a more recent update of the above data, CDC reports that in 2009-2010, there were 33 drinking water outbreaks. Of the 33 outbreaks, 25 (75.8%) occurred in community water systems.
6.2. Types of distribution deficiencies
Cross-connections and backflow issues pose serious public health threats. A backflow occurs when non-potable water flows directly into the drinking water supply through a cross connection, which occurs when the system has low water pressure or the non-potable system has backpressure . A study that monitored public drinking supply distribution system failures from 1981 to 2002 found that 50% of waterborne outbreaks were the result of backflow . A study by the University of Southern California examined the plumbing systems in 188 homes and found 9.6 percent had a direct cross connection that presented a health risk .
Water main breaks are another serious problem in the United States. Each day more than 700 water mains break, 36 exposing distribution system water and pipe interiors to external microbial and chemical contaminants, both during the break and the repair process. The EPA estimated in 2002 that 5 percent of all waterborne outbreaks due to distribution system deficiencies were caused by water main repairs or the installation of new pipes .
Issues with finished water storage (uncovered and reservoirs) is another cause of waterborne outbreaks as drinking water quality degrades over time and is susceptible to external contamination from wildlife, rain and algae . Other public water supply distribution system risks include: biofilm build-up (the growth of bacteria on distribution system pipes and household plumbing), low-pressure intrusions  caused by leaks, permeation and leaching (in fact, 7 billion gallons leak from public water supply distribution pipes each day in the US  and the cost of water losses in 1994 was estimated $2.8 billion annually ).
Biofilm build-up, by itself, has been the subject of study by the EPA, which has concluded that: “Biofilms likely exist in all distribution systems, and are recognized as a normal part of the distribution system”. Moreover, “…a wide range of primary and opportunistic pathogens have demonstrated the ability to survive, if not grow, in biofilms. These pathogens are of both fecal and non-fecal origin, and have a multitude of pathways through which they can enter the distribution system. Some of the pathogens identified as growing or potentially surviving in biofilms include Legionella, Mycobacterium avium complex, Pseudomonas aeruginosa, poliovirus 1, coxsackievirus B and several species of fungi. …Once becoming established as part of the biofilm, pathogens can be protected from disinfection .”
6.3. Costs to address deficiencies in us public water supply distribution systems
According to the EPA’s Drinking Water Infrastructure Needs Survey and Assessment, 2009, the national assessment of public water system infrastructure needs shows a total twenty-year capital improvement need of $334.8 billion, to repair or replace thousands of miles of pipe, thousands of treatment plants, storage tanks and other assets to protect the public health . The pie chart below shows the majority of need is to address deficiencies with the public water supply distribution systems that include co-residency of leaking water pipes in the same trenches with leaking sewage lines .
In 2002, the EPA released a Clean Water and Drinking Water Infrastructure Gap Analysis Report, which calculated a “funding gap” of more than $500 billion dollars over the next 20 years. (Includes $122 billion for clean water capital costs, $102 billion for drinking water capital costs, $148 billion for clean water operation and maintenance and $161 billion for drinking water operation and maintenance ).
6.4. Water distribution
Under FDA rule (21 CFR Part 129), bottled water is: “required to be safe and that it be processed, bottled, held and transported under sanitary conditions. Processing practices addressed in the Current Good Manufacturing Practice (CGMP) regulations include protection of the water source from contamination, sanitation at the bottling facility, quality control to assure the bacteriological and chemical safety of the water, and sampling and testing of source water and the final product for microbiological, chemical, and radiological contaminants. Bottlers are required to maintain source approval and testing records to show to government inspectors .”
In addition, bottled water companies are required to conduct daily in-house total coliform monitoring on finished product of each product type and quarterly microbial rinse/swab tests which may be performed in-house by qualified plant personnel or by an approved laboratory on containers (incoming as well as those immediately from the washer) and closures as stipulated in 21 CFR Section 129.80 (f) . This specific standard of sanitation for the interior of bottles and caps is: "No more than one of the four samples may exceed more than one bacterium per milliliter of capacity or one colony per square centimeter of surface area. All samples shall be free of coliform organisms.” For example, not more than one of four 500 ml containers shall exceed 500 CFUs of bacteria. None of the containers are permitted to be positive for coliform bacteria. In comparison, there is an EPA guideline of 500 CFU/ml of heterotrophic plate count bacteria for public drinking water in the distribution system, beyond which the public water system must adjust disinfection levels to reduce the bacteria count. However, distribution pipes may still be lined with biofilms that may contribute to the bacteria load in the water.
Throughout the bottled water distribution system, each bottle is sealed and must remain sealed until it is opened by the consumer thus eliminating risk the of contamination during the distribution process. In addition, in the unlikely event that a problem with bottled water occurs, the product can be easily identified and recalled using a lot number printed on the bottled water container.
The quality of drinking water in the United States is extensively monitored and regulated by federal, state and local agencies, yet a close examination of both public system drinking water and bottled water processing and distribution procedures reveals striking differences that could explain why consumers have safety concerns regarding tap water. This paper has shown that on a gallon for gallon basis bottled water is tested more often than tap water. It is also the case that water quality breach notification differences means tap water drinkers would consume potentially hazardous drinking water before they are notified. Bottled water is tested before the water leaves the plant, and is withheld or withdrawn if the water does not meet FDA water quality standards.
A comparison of waterborne illness outbreaks reveals overwhelming evidence that the microbial health risks associated with drinking tap water are far greater than that of bottled water, with 195 million illnesses in the past 10 years for tap water compared to fewer than a dozen for bottled water.
In examining public water supply distribution systems, this paper highlights how deficiencies in these systems are key factors and causes of compromised tap water quality.
Overall, water is a precious resource. It has many uses for which there is no substitute and is therefore needed in many different ways for our survival and endurance. Thus, safe drinking water holds great value and to maintain its safety the public needs to stay educated and aware. Our government regulations are working to protect and produce our safe drinking water supply, but more needs to be done. And an informed consumer can help drive policies that will meet the needs of the American people—and ensure a safe drinking water supply.
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