(BEING CONTINUED FROM 19/06/13 )
EPA and FDA Regulations
The United States Environmental Protection Agency (EPA) is the regulatory agency behind the public
water supplies of surface water through the Safe Drinking Water Act. Bottled drinking water on the other hand
mainly comes from groundwater, but since many municipalities already use surface water as their source, and
some bottlers use municipality sources, bottled water can come from surface water as well. Additionally, the
Food and Drug Administration (FDA) regulates bottled water as a packaged food under the Federal Food, Drug,
and Cosmetic Act. The EPA then creates the standards for tap water that is supplied by public suppliers, while
the FDA creates standards for bottled water based off the EPA standards (EPA, 2005).
The reason the two waters are regulated under different entities is because bottled water did not truly
exist when the laws were being drafted. “The federal agencies given oversight over our drinking water have no
authority over bottled water- a product never anticipated by the drafters of the original federal drinking water
laws. Instead the FDA regulates bottled water because it is considered a ‘food product’ sold in individual
containers,” (Gleick, 2010, p. 34).
EPA Safe Drinking Water Act
The Safe Drinking Water Act (SDWA) requires the EPA to establish primary and secondary national
standards for public water systems to control the level of contaminants in drinking water (US GAO, 2009).
National primary regulations are legally enforceable standards of contaminant levels, while national secondary
regulations are non-enforceable standards that affect the aesthetic or cosmetic qualities of the water, such as
taste, odor, and color (US GAO, 2009). The EPA has national primary drinking water regulations for 88
contaminants (US GAO, 2009). The SDWA also requires public water systems to release annual water quality
reports to their customers that summarize local water quality about the water’s source, quality, and
contaminants (US GAO, 2009). These public water quality reports can be accessed online at anytime. The SDWA
even provides provisions to protect groundwater sources, funds for water system upgrades, and assessment of
drinking water sources to contamination (EPA, 2009).
Accordingly, tap water is rigorously tested under such EPA supervision. Tap water that comes from a
public supplier requires disinfection, hundreds of tests per month for bacteria, pathogen filtration, no confirmed
E. coli and Fecal Coliform, testing for Cryptosporidium and Giardia, and one per quarter testing for synthetic
organic chemicals (NRDC, 1999). Bottled water does not have such regulation (Table 2). There are even certain
regulated contaminants that must be monitored in city tap water and not in bottled water. Some of these
contaminants include asbestos, bromate, Di (2-Ethylhexyl) phthalate, and Haloacetic acids (NRDC, 1999). There
is also a long list of unregulated contaminants for tap water that do not have a maximum contaminant limit, but
still must be measured. Some of the unregulated contaminants that are monitored in tap water and not in
bottled water include Dibromomethane, Chlorotoluene, and Dichloropropene (NRDC, 1999).
The annual reports that are required by the law inform the community of the types and size of
contamination that may occur in their drinking water. The 2010 Water Quality Report for Bloomington, Indiana,
provides the public with sources of their contamination, the highest levels allowed, the highest levels detected,
and the EPA’s ideal goals (Table 3). If there is anything in the water quality report the community is unsure of,
they are encouraged to call the EPA’s Safe Drinking Water Hotline.
FDA Federal Food, Drug, and Cosmetic Act
On the other hand, bottled water is not as strictly regulated under the FDA. Bottled water regulation is
also filled with loopholes that allow some waters to be unreliable. For example, water that is packaged and sold
in the same state is exempt from FDA regulations, and that includes 60-70% of the bottled water sold in the
United States (NRDC, 1999). FDA’s review chemist in food safety, Lauren Robin, explains, “If it is produced in
Maine, and sold within Maine, it is not under FDA jurisdiction. We regulate products that are in interstate
commerce. That means products that move from state to state,” (Soechtig, 2009).
Bottled water is tested significantly less for contaminants and purity than tap water. The FDA allows for
E. coli and Fecal Coliform contamination, unlike tap water (NRDC, 1999). Bottled water does not have to be
tested for Cryptosporidium and Giardia either. The reason the FDA has no standard for Cryptosporidium is
because bottled water comes from either a municipal source or spring water, which is also groundwater, and
thus should be protected from such contamination. Bottlers do not have to test for it because they just assume
that the contaminants aren’t there (Gleick, 2010, p. 76). In addition, no disinfection or pathogen filtration is
required, bacteria testing only takes place once a week, and testing for synthetic organic chemicals is only once
a year (NRDC, 1999).
Bottlers are not invincible, and one should not assume so. The EPA has even found 27 percent of
groundwater wells studied to sometimes have viral contamination. The Agency’s report states, “EPA determined
that there is the potential for ground water to be contaminated with pathogenic bacteria or viruses, or both,and that the presence of fecal indicators can demonstrate a pathway for pathogenic enteric bacteria or viruses
to enter ground water sources,” (Gleick, 2010, p. 77). Since bottlers assume the contaminants are not there,
they are not testing for them, or doing anything proactive about it. If contaminants exist the EPA requires
municipal water to be treated while, bottled water is not required to do so (Gleick, 2010, p. 77).
Furthermore, the FDA does not require bottled water manufacturers to submit a regular testing report
to the agency (Soechtig, 2009). These reports are also not made available to the public. Jane Houlihan, Vice
President of Research at Environmental Working Group, quipped, “Those tests can stay hidden in company filing
cabinets, they can stay in back up hard drives,” (Soechtig, 2009). Ultimately, the public is not going to see them.
Overall, rules and regulations do not seem to apply for bottled water. A July 2007 report on general
food safety from the House Energy and Commerce Committee states, “FDA has no rules governing testing
protocols, record retention. . . manufacturing, quality assurance and control, or the right to examine any records
that a food processing firm chooses to keep voluntarily,” (Royte, 2008, p. 145). According to William K. Hubbard,
a former FDA assistant commissioner, most domestic plants are inspected only once every 5 to 10 years (Royte,
2008, p. 145). That is not nearly enough to provide safe drinking water to consumers.
The rules are not even rules; they are suggestions as in Title 21, part 129, section 35 of the FDA
regulations, which specifies details for testing bottled water, states: “Analysis of the sample may be performed
for the plant by competent commercial laboratories (e.g., EPA and State-certified laboratories). [emphasis
added+” (Gleick, 2010, p. 41). Should we be drinking bottled water that does not have to be tested?
The International Bottled Water Association and NSF International
Specifically, the EPA and the FDA do not certify bottled water, so there are two organizations that do:
The International Bottled Water Association (IBWA) and NSF International (EPA, 2005). The IBWA is a trade
organization for water bottlers and requires its members to meet its “model code” and annual inspections (EPA,
2005). An example of an IBWA certified company is Nestlé Waters North America Inc., which includes brands such as Ice Mountain, San Pellegrino, Poland Spring, Perrier, and Nestlé Pure Life (IBWA, 2009). NSF International has its members undergo random unannounced plant inspections, and those who are certified must meet all FDA requirements (EPA, 2005). Some NSF International certified brands include Nestlé Waters North America Inc.’s Arrowhead, and then Fiji, and Evian (NSF, 2010).
Different Agencies, Different Rules
It makes sense that if our waters are not under the same regulation that there will be discrepancy
between them. Both the EPA and the FDA have many other duties besides just testing and making sure our
water is safe to drink. David Michaels (PH.D., M.P.H.), an Environmental and Occupational Health Professor at
George Washington University revealed that the FDA is overwhelmed with the drug industry, causing the
inspection and regulation of bottled water to be of a lower priority (Soechtig, 2009). “While utilities test tap
water hundreds of thousands of times a year and report their results to state and federal agencies, bottling
plants self-test, and they host an FDA inspector infrequently. The plants have low priority, says the agency,
because the industry has a good safety record. When inspectors do show up, they test only for selected
contaminants, depending on the reason for the sampling,” (Royte, 2008, p. 145). These differences are a result
of our nation’s inconsistency with drinking water regulation.
Different regulatory agencies cause there to be different rules, and different rules call for a difference in
the quality of water. In 1998 the Natural Resources Defense Council (NRDC) tested a thousand samples of 103
brands of bottled water (Royte, 2008, p. 142). One third of the samples revealed contaminants such as arsenic,
bromine, and Coliform bacteria. Arsenic is one of contaminants addressed in the EPA’s national primary drinking
water regulations and has a legally enforceable maximum contaminant level, unlike bottled water. Then in 2004,
the American Society of Microbiology tested 68 types of mineral water to find 40 percent with bacteria or fungi
and 21 had the ability to support bacterial growth in lab cultures (Royte, 2008, p. 143). Even though these
bacteria are technically safe to drink under EPA standards, it is not recommended for those who are young, old,
Often, we are mislead by the pristine pictures on the labels of our bottled water. It probably was not
bottled on the top of an untouched glacier (Table 4). Instead, some bottles have been found to contain benzene,
mold, sodium hydroxide, kerosene, styrene, algae, yeast, tetrahydrofuran, sand, Fecal Coliforms and other forms
of bacteria, elevated chlorine, ‘filth’, glass particles, sanitizer, and even crickets (Gleick, 2010, p. 47). Benzene
and styrene are both monitored under the SDWA; benzene leaching from gas storage tanks and styrene from
discharge from rubber and plastic factories (EPA, 2009).
A great example of bottler water companies caught in a lie is the 2006 Fiji Water advertisement. The
magazine ad read, “The label says Fiji because it’s not bottled in Cleveland.”After seeing the ad, Ciaccia, the
company responsible for managing Cleveland’s water system, had Fiji’s water tested. They found that both Fiji
and Cleveland’s water met all federal standards, but the lab results found that Fiji Water contained volatile
plastic compounds, 40 times more bacteria than are found in well-run municipal water systems, and over six
micrograms per liter of arsenic (Gleick, 2010, p. 16).
Since the bottled water companies are not required to notify the public with annual water quality
reports, it is not common to hear about illness resulting from bottled water consumption. Rather, the media has
a field day when a lot of people become ill from municipal supplies. Ultimately, there have not been any
confirmed cases of illness from drinking bottled water in the United States. This could be because it just has not
happened, it was not reported to the public, or it happened but the source of illness was not successfully traced
(Royte, 2008, p. 146). A report from the Worldwatch Institute found that products can be recalled up to 15
months after the contaminated water has been produced, distributed, and sold (Royte, 2008, p. 146). What
good is a water recall when chances are the water has already been consumed?
Due to the fear of tap water, many drink bottled water assuming it is the healthier option. “Some people
have gone to drinking bottled water literally because they are concerned about their water, and the problem is
they are unaware of the fact that buying bottled water is not necessarily safe, that you end up being exposed to
other chemical compounds,” cautioned Stephan King, (PH.D., M.P.H.) a toxicologist and epidemiologist with
Toxicology Inc. (Soechtig, 2009). The information label lists all the nutritional aspects that water lacks, but there
are still lots of things in our water (Gleick, 2010, p. 59). On contrary, bottled water can actually lead to health
concerns for those with a weak immune system, such as the elderly, infants, and cancer, transplant, and
HIV/AIDS patients (NRDC, 1999).
In 2009, the documentary, Tapped, produced an independent study of what is really in bottled water
with the help of Dr. King. In one study, they used bottles bought off the shelves at a grocery store. What they
found horrified Dr. King. Test America found that their store-bought samples contained toluene, a constituent in
gasoline and has been used in paint thinners. This neurotoxic agent can be linked to adverse reproductive
effects. In the second study, they sampled bottled water that had been left in the trunk of a car for one week.
The test identified styrene, a cancer causing agent that can also cause adverse reproductive effects, in the
water. Both toluene and styrene are monitored under the SDWA. Additionally, three different types of
phthalates were found: diethyl phthalate, dimethyl phthalate, and di-n-octyl phthalate. Phthalates are known to
cause dysfunction in the fetus and adverse reproduction outcomes for males and females (Soechtig, 2009).
Adrianna Quintero, senior attorney for the Natural Resources Defense Council, revealed that, “It really concerns
me when I see mothers blindly trusting bottled water and handing their children bottles of water. Putting their
complete trust in a product without so much as questioning, what am I giving my child?” (Soechtig, 2009).
Even more frightening than what is in our water, is that we do not know how these contaminants will
affect human health in the long run. Melissa Jarrell, (PH.D.) assistant professor of criminology at Texas A&M
University, believes, “We don’t know what the long term consequences are to this type of exposure. So people
think when they’re drinking bottled water, that they’re getting a health product. They’re not conditioned to
think, well, maybe there is something in the plastic. And then we trust government, we trust industry, when
they say everything is okay, we say okay sounds good to us,” (Soechtig, 2009). Even worse is that the scientists
who work for product defense companies are never going to produce a study, let alone publish one, that finds
an unflattering result. Their entire job depends on it, alleged David Michaels. These bottled water companies are
working hard to keep the public from knowing what can be in their drinking water.
(TO BE CONTINUED)
Marguerite Kaye Huber
Abstract submitted for SPEA Undergraduate Honors Thesis Presentations
School of Public and Environmental Affairs