Bottled Water
FDA Safety and Consumer Protections Are Often Less Stringent Than Comparable EPA Protections for Tap Water Gao ID: GAO-09-610 June 22, 2009Over the past decade, per capita consumption of bottled water in the United States has more than doubled. With this increase have come several concerns in recent years about the safety, quality, and environmental impacts of bottled water. The Food and Drug Administration (FDA) regulates bottled water under the Federal Food, Drug, and Cosmetic Act as a food and is responsible for ensuring that domestic and imported bottled water is safe and truthfully labeled. Among other things, GAO (1) evaluated the extent to which FDA regulates and ensures the quality and safety of bottled water; (2) evaluated the extent to which federal and state authorities regulate the accuracy of labels and claims regarding the purity and source of bottled water; and (3) identified the environmental and other impacts of bottled water. GAO reviewed FDA data, reports, and requirements for bottled water; conducted a state survey of all 50 states and the District of Columbia; reviewed bottled water labels; and interviewed FDA officials and key experts.
FDA's bottled water standard of quality regulations generally mirror the Environmental Protection Agency's (EPA) national primary drinking water regulations, as required by the Federal Food, Drug, and Cosmetic Act, although the case of DEHP (an organic compound 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. GAO also found that FDA's regulation of bottled water, particularly when compared with EPA's regulationof tap water, reveal 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 GAO's other findings, the state requirements to safeguard bottled water often exceed FDA's, but still are often less comprehensive than state requirements to safeguard tap water. 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. Like other foods, bottled water labels must 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. The agency was not required to conduct rulemaking to require that manufacturers provide such information to consumers, however, and it has not done so. Nevertheless, GAO's work suggests that consumers may benefit from such additional information. For example, when GAO 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. GAO 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 it reviewed, companies it contacted, or company Web sites it reviewed. Among the environmental impacts of bottled water are the effects on U.S. municipal landfill capacity and U.S. energy demands. Regarding impacts on landfill capacity, GAO 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. Discarded water bottles, however, represented less than 1 percent of total municipal waste that EPA reported entered U.S. landfills in 2006. Regarding the impact on U.S. energy demands, a recent peer-reviewed article found that the production and consumption of bottled water comprises a small share of total U.S. energy demand but is much more energy-intensive than the production of public drinking water.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-09-610, Bottled Water: FDA Safety and Consumer Protections Are Often Less Stringent Than Comparable EPA Protections for Tap Water
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
June 2009:
Bottled Water:
FDA Safety and Consumer Protections Are Often Less Stringent Than
Comparable EPA Protections for Tap Water:
GAO-09-610:
GAO Highlights:
Highlights of GAO-09-610, a report to congressional requesters.
Why GAO Did This Study:
Over the past decade, per capita consumption of bottled water in the
United States has more than doubled. With this increase have come
several concerns in recent years about the safety, quality, and
environmental impacts of bottled water. The Food and Drug
Administration (FDA) regulates bottled water under the Federal Food,
Drug, and Cosmetic Act as a food and is responsible for ensuring that
domestic and imported bottled water is safe and truthfully labeled.
Among other things, GAO (1) evaluated the extent to which FDA regulates
and ensures the quality and safety of bottled water; (2) evaluated the
extent to which federal and state authorities regulate the accuracy of
labels and claims regarding the purity and source of bottled water; and
(3) identified the environmental and other impacts of bottled water.
GAO reviewed FDA data, reports, and requirements for bottled water;
conducted a state survey of all 50 states and the District of Columbia;
reviewed bottled water labels; and interviewed FDA officials and key
experts.
What GAO Found:
FDA‘s bottled water standard of quality regulations generally mirror
the Environmental Protection Agency‘s (EPA) national primary drinking
water regulations, as required by the Federal Food, Drug, and Cosmetic
Act, although the case of DEHP (an organic compound 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. GAO also found that FDA‘s regulation of bottled water,
particularly when compared with EPA‘s regulation of tap water, reveal
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 GAO‘s other findings, the state requirements to safeguard bottled
water often exceed FDA‘s, but still are often less comprehensive than
state requirements to safeguard tap water.
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. Like other foods, bottled water labels
must 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. The agency was not required to conduct rulemaking to require
that manufacturers provide such information to consumers, however, and
it has not done so. Nevertheless, GAO‘s work suggests that consumers
may benefit from such additional information. For example, when GAO
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. GAO 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 it reviewed, companies it contacted, or company
Web sites it reviewed.
Among the environmental impacts of bottled water are the effects on
U.S. municipal landfill capacity and U.S. energy demands. Regarding
impacts on landfill capacity, GAO 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. Discarded
water bottles, however, represented less than 1 percent of total
municipal waste that EPA reported entered U.S. landfills in 2006.
Regarding the impact on U.S. energy demands, a recent peer-reviewed
article found that the production and consumption of bottled water
comprises a small share of total U.S. energy demand but is much more
energy-intensive than the production of public drinking water.
What GAO Recommends:
GAO recommends that FDA (1) issue a standard of quality for DEHP, or
publish its reasons for not doing so, and (2) implement its findings
regarding methods that are feasible for conveying information to
consumers regarding the quality and safety of bottled water. FDA
generally agreed with GAO‘s recommendations.
View [hyperlink, http://www.gao.gov/products/GAO-09-610] or key
components. For more information, contact John Stephenson at (202) 512-
3841 or stephensonj@gao.gov.
[End of section]
Contents:
Letter:
Background:
FDA's Bottled Water Standard of Quality Regulations Are Similar to
EPA's Drinking Water Standards, but the Agency's Authority to Enforce
Them Is Weaker:
FDA and State Bottled Water Labeling Requirements Resemble Those for
Other Food Types, but Demand Less Information Than Is Required for Tap
Water:
Production and Consumption of Bottled Water Has Varied Impacts on the
Environment:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Scope and Methodology:
Appendix II: FDA and IBWA Standards of Quality and Selected EPA
Drinking Water Standards:
Appendix III: Telephone Survey Administered to Officials from the 50
States and the District of Columbia, and Summary of Responses:
Appendix IV: Comments from the Department of Health and Human Services'
Food and Drug Administration:
Appendix V: GAO Contact and Staff Acknowledgments:
Table:
Table 1: Types of Bottled Water Under the Standard of Identity
Regulation:
Figure:
Figure 1: Bottled Water Facility Inspections Conducted by FDA and
States, Fiscal Years 2000 through 2008:
Abbreviations:
DEHP: di(2-ethylhexyl)phthalate:
EPA: Environmental Protection Agency:
FDA: Food and Drug Administration:
FFDCA: Federal Food, Drug, and Cosmetic Act:
IBWA: International Bottled Water Association:
PET: polyethylene terephthalate:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
June 22, 2009:
The Honorable Henry Waxman:
Chairman:
Committee on Energy and Commerce:
House of Representatives:
The Honorable Edward Markey:
Chairman:
Subcommittee on Energy and Environment:
Committee on Energy and Commerce:
House of Representatives:
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 and other groups has shown
that bottled water is not necessarily cleaner than tap water.
Furthermore, bottled water, like tap water, has been found in some
cases to have contamination levels in excess of water quality standards
used by the Environmental Protection Agency (EPA) for public water
systems and adopted by the Food and Drug Administration (FDA) for
bottled water. In addition to the concerns about the quality and safety
of bottled water, consumer groups have also questioned whether
consumers are adequately informed about the source of bottled water,
how it is treated, and its quality. Finally, bottled water's potential
environmental impact also has 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.
In this context, you asked us to (1) evaluate the extent to which
federal and state authorities, as well as their counterparts in other
countries, regulate the quality of bottled water to ensure its safety;
(2) evaluate 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) identify the environmental and other impacts of
bottled water.
To address these objectives, we reviewed relevant 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 telephone survey of all
50 states and the District of Columbia; and conducted interviews with
EPA and FDA officials and a variety of experts from nonprofit
organizations and industry associations. We also examined bottled water
labels[Footnote 1] and contacted companies to determine the information
they provide to consumers. A total of 83 bottled water labels were
examined after removing duplicate labels or labels that were not for
bottled water that were collected from GAO staff in each of our 11
field offices and at headquarters. In addition, we reviewed how several
of the top exporting countries--including Canada, Fiji, and Turkey as
well as the European Union and its member states--regulate bottled
water. Finally, we interviewed experts and other knowledgeable
officials and conducted a literature review regarding the environmental
impacts of bottled water. 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 on our audit objectives.
Appendix I discusses our scope and methodology in more detail.
Background:
The rapid growth in the consumption of bottled water has been
attributed to a variety of factors. In a 2002 survey, The Gallup
Organization (Gallup) found that the leading reason that consumers
purchased bottled water was due to health-related issues; taste was the
second leading reason, and the convenience of bottled water was also a
factor.
Tap water and bottled water are regulated under two different federal
laws--the Safe Drinking Water Act and the Federal Food, Drug, and
Cosmetic Act (FFDCA), respectively. Under the Safe Drinking Water Act,
EPA, or states that have primary enforcement responsibility[Footnote
2], are responsible for protecting the public from the risks of
contaminated drinking water from public water systems and for ensuring
that the public receives information on the quality of the water
delivered by these systems[Footnote 3]. Specifically, the law requires
EPA to establish national primary and secondary drinking water
regulations for public water systems to control the level of
contaminants in drinking water. National primary drinking water
regulations are legally enforceable standards that protect water
quality by limiting the levels of specific contaminants that can
adversely affect public health and are known or anticipated to occur in
water. Such standards take the form of either maximum contaminant
levels or treatment techniques. EPA currently has national primary
drinking water regulations for 88 contaminants. The agency may also set
monitoring requirements to assist in determining whether public water
systems are in compliance with the Safe Drinking Water Act. National
secondary drinking water regulations are nonenforceable guidelines to
control contaminants in drinking water that primarily affect the
aesthetic or cosmetic qualities--such as taste, odor, or color--
relating to public acceptance of drinking water. Although not required
by EPA, states with primary enforcement responsibility may choose to
adopt these secondary regulations as enforceable regulations in the
state. Under the law, EPA regulations also require that public water
systems provide consumer confidence reports--also known as annual water
quality reports or drinking water quality reports--to their customers
each year. These reports summarize local drinking water quality
information about the water's sources, any detected contaminants, and
compliance with national primary drinking water regulations as well as
information on the potential health effects of certain drinking water
contaminants.
Because the FFDCA treats bottled water as a food, FDA, within the
Department of Health and Human Services, has broad statutory authority
to ensure that bottled water that is sold in interstate commerce is
safe, wholesome, and truthfully labeled. FDA has established specific
regulations for bottled water, including a standard of quality, a
standard of identity, and current good manufacturing practices. FDA
establishes allowable levels for contaminants under the standard of
quality for bottled water sold in interstate commerce on the basis of
the national primary drinking water regulations established by EPA. By
law, no later than 180 days before the effective date of a national
primary drinking water regulation, FDA is required to issue a standard
of quality regulation for that contaminant in bottled water or make a
finding that such a regulation is not necessary to protect the public
health because the contaminant is contained in water in public water
systems, but not in water used for bottled water.[Footnote 4] FDA's
standard of quality regulation must be no less stringent than EPA's
maximum contaminant level for drinking water, or no less protective of
public health than the treatment technique required by the national
primary drinking water regulation. If FDA fails to promulgate a
standard of quality by the statutory deadline, the EPA national primary
drinking water regulation will be considered as the standard of quality
for bottled water.[Footnote 5] When establishing a standard of quality
regulation for bottled water, FDA also establishes monitoring
requirements that the agency determines to be appropriate.
Under FDA's standard of identity regulation for bottled water, the
agency defines bottled water as water that is intended for human
consumption and that is sealed in bottles or containers with no added
ingredients, except that it may contain safe and suitable antimicrobial
agents. The standard of identity regulation also defines various types
of bottled water, such as "artesian water," "ground water," and "spring
water," among others.
FDA has also established current good manufacturing practice
regulations specific to bottled water. These regulations cover
protection of the water source from contamination; sanitation at the
bottling facility; and sampling and testing requirements for
microbiological, chemical, and radiological contaminants. Bottled water
is one of the few foods subject to both current good manufacturing
practice regulations for foods in general and to current good
manufacturing practice regulations specific to the commodity itself.
Bottlers must test their source water once a week for microbiological
contaminants, unless it comes from a municipal source, which must meet
EPA testing requirements. Source water must be tested at least once a
year for chemical contaminants and once every 4 years for radiological
contaminants. Finished bottled water must be tested weekly for
microbiological contaminants and at least annually for chemical,
physical, and radiological contaminants. If bottled water contains
contaminants at levels considered injurious to health, it is deemed to
be adulterated and is subject to enforcement action.
To ensure that bottled water facilities and bottled water meet federal
requirements, FDA uses a multipronged approach. The agency (1) requires
bottlers to use water sources (e.g., wells, springs, and public
drinking water systems) that have been tested and approved by
government agencies having jurisdiction, such as state or local
agencies; (2) inspects domestic bottling plants for proper operating
practices and cleanliness; (3) inspects labels to confirm that labeling
complies with FDA regulations; and (4) requires bottlers to test their
source water and bottled water periodically to ensure compliance with
the bottled water standard of quality. Furthermore, FDA tests selected
samples of domestic source waters and finished bottled water for
contaminants. Finally, for imported bottled water, FDA uses the same
review process that applies to all imported food products.
States are also responsible for regulating bottled water. Under FDA's
current good manufacturing practice regulations for bottled water, only
approved sources of water can be used to supply a bottled water
facility. The states or localities are responsible for approving
sources of water, which may involve inspecting the source and reviewing
water quality analyses. Some states also conduct inspections of bottled
water facilities under contract with FDA. In addition, the states are
solely responsible for regulating bottled water manufactured and sold
within a single state, which does not generally fall under FDA
jurisdiction.
In addition to federal and state regulations and requirements for
bottled water, industry standards have been established, through a code
of practice, by the International Bottled Water Association (IBWA), to
which its members are required to adhere. According to IBWA, its
membership includes about 80 percent of the bottled water manufacturers
in the United States.[Footnote 6] To be a member, IBWA requires bottled
water facilities to undergo an annual plant inspection, conducted by an
independent third-party organization, to assess compliance with all
applicable regulations. The code of practice also establishes security
standards that IBWA-member bottled water facilities must meet to ensure
a secure facility. Such security standards are not required by FDA for
bottled water facilities, but the agency does have guidance available
for the facilities to follow.[Footnote 7] In addition, IBWA's code of
practice also contains water quality standards for bottled water, some
of which are more stringent than those of FDA under the standard of
quality. (See appendix II for a comparison of these standards.)
FDA's Bottled Water Standard of Quality Regulations Are Similar to
EPA's Drinking Water Standards, but the Agency's Authority to Enforce
Them Is Weaker:
FDA's bottled water standard of quality regulations, for the most part,
mirror EPA's drinking water requirements, although the case of DEHP (an
organic compound widely used in the manufacture of polyvinyl chloride
plastics) is a notable exception. However, FDA's implementation of
these regulations, particularly when compared with EPA's implementation
of its regulations concerning tap water, reveal key differences that
reflect the limited nature of FDA's approach to regulating bottled
water. At the heart of these differences is that EPA regulates tap
water under the Safe Drinking Water Act, while FDA regulates bottled
water as a "food" under the FFDCA, which does not grant FDA statutory
authority to implement regulations similar to those of EPA. These
differences are amplified by the fact that among the foods it
regulates, using a risk-based approach, FDA generally accords bottled
water a low priority.
FDA's Standard of Quality Regulations for Bottled Water Generally
Mirror EPA's Drinking Water Requirements, Except in the Case of DEHP:
We found that, for the most part, FDA's bottled water standard of
quality regulations are equivalent to EPA's regulations for drinking
water, but FDA has yet to set a standard for DEHP. Under the FFDCA, FDA
is required to establish standard of quality regulations for bottled
water that are no less stringent than the maximum contaminant levels
established in EPA's national primary drinking water regulations, and
the agency has done so for most contaminants. In most cases where FDA
has not adopted EPA's national primary drinking water regulations, the
agency has provided a rationale for not doing so. For example, FDA
stated that it did not adopt EPA's maximum contaminant level for
asbestos or EPA's treatment technique for the parasite Cryptosporidium
because if municipal water is used as a source, it already has to meet
EPA regulations, and it is unlikely that other sources of water, such
as springs and aquifers, would contain these contaminants.
One exception, however, is the case of a phthalate, DEHP.[Footnote 8]
FDA has yet to establish a standard for this contaminant, even though
EPA established a national primary drinking water regulation for it in
1992 and FDA's statutory deadline for adopting the standard was in
January 1993.[Footnote 9] EPA found that the potential health effects
from exposure to DEHP above the maximum contaminant level could include
reproductive difficulties, liver problems, and increased risk of
cancer. Although FDA proposed a standard in August 1993, the agency
subsequently deferred action on DEHP and has yet to either adopt a
standard or publish a reason for not doing so.[Footnote 10] The agency
delayed action on DEHP in 1996 because the compound was already
approved for use in packaging that comes in contact with food
(including bottled water), which FDA believed could have created a
potential conflict with FDA's proposed standard of quality for DEHP.
According to FDA officials, an agency task force is currently examining
information regarding the use of phthalates, including DEHP, in food
contact materials. The results of this work by the task force will be
used to set a standard for DEHP, but it is unclear when FDA will
complete the study. Because FDA has not established a standard of
quality for DEHP in bottled water, bottled water facilities are not
required to test for it.
FDA's Regulation of Bottled Water Has Generally Been Limited and
Differs from EPA's Regulation of Drinking Water in Key Ways:
While FDA's standard of quality regulations for bottled water are
generally consistent with EPA's drinking water requirements, FDA's
regulation of bottled water has been limited. Among our key findings
are that (1) when compared with EPA's regulation of public water
systems, several key differences reflect the limited nature of FDA's
regulation of bottled water, particularly regarding how violations are
reported and whether the use of certified laboratories is required; (2)
because FDA's experience over the years has not shown that bottled
water poses a significant public health risk, the agency devotes fewer
resources to the enforcement of bottled water regulations than it does
for higher risk foods; (3) while state regulatory requirements for
bottled water often meet or exceed those of FDA, the requirements vary
across the states and, in some states, are still less comprehensive
than state requirements for tap water under the Safe Drinking Water
Act; and (4) FDA's oversight of imported bottled water is limited.
FDA's Regulation of Bottled Water Is Generally Weaker Than EPA's
Regulation of Tap Water:
FDA's regulation of bottled water differs from EPA's regulation of
drinking water in key ways, largely because FDA does not have the
specific statutory authority to regulate bottled water in the same
manner EPA regulates drinking water. These differences relate to how
violations are reported, whether bottlers are required to use certified
laboratories to test their water, and the retention of water quality
testing records.
* How violations are reported: The FFDCA does not specifically
authorize FDA to require bottlers to report test results, even if
violations of the standard of quality regulations are found. Instead,
inspectors review testing records when they inspect bottling
facilities. In contrast, under the Safe Drinking Water Act, public
water systems must notify the public as well as the appropriate
regulatory agency (e.g., state environmental agency) within 24 hours of
detecting certain violations of the national primary drinking water
regulations that have significant potential to have serious adverse
effects on human health as a result of short-term exposure. For
violations that have the potential to have serious adverse effects on
human health and all other violations, public water systems must
provide notice within 30 days and 1 year, respectively. FDA officials
told us that to comply with the Food and Drug Administration Amendments
Act of 2007,[Footnote 11] the agency is developing a means for all food
facilities it regulates to report instances when there is a reasonable
probability that the use of, or exposure to, a food will cause serious
adverse health consequences or death to humans or animals. This act
required FDA to establish, by September 2008, a Reportable Food
Registry--an electronic portal by which responsible parties or public
health officials may submit such instances to FDA. FDA officials have
told us that the registry is still under development, and that it is
taking steps to create an interim Reportable Food Registry by the end
of fiscal year 2009.
* Whether certified laboratories are used: Another key difference is
that FDA does not require bottle water facilities to use certified
laboratories for water quality tests. Public water systems are required
by the Safe Drinking Water Act to use such laboratories. In this
regard, bottled water is treated like other food products, which
generally are not required to be tested by certified laboratories.
Instead, under the bottled water current good manufacturing practice
regulations, sample analysis of source water and finished products may
be performed by competent commercial laboratories. EPA and state-
certified laboratories are cited as examples of competent commercial
laboratories, but use of these certified laboratories is not required.
FDA officials have stated that they are not aware of any special
grounds or particular need to require the use of certified laboratories
for bottled water. In addition, under the Safe Drinking Water Act,
operators of public water systems must be certified to ensure that
their public water system provides an adequate supply of safe, potable
drinking water. There is no such requirement for operators of bottled
water facilities.
* Retention of water quality testing records: FDA requires that bottled
water facilities retain the results of all water quality tests for up
to 2 years. On the other hand, EPA requires that public water systems
retain the results of microbiological tests for 5 years and the results
of chemical tests for 10 years. As we discuss in the following section,
because FDA inspections of bottled water facilities are infrequent and
because reporting is not required if problems are found, FDA would most
likely not be aware that a contamination problem existed if a facility
was not inspected within a 2-year time frame.
FDA's Risk-Based Approach Accords Low Priority to Inspections of
Bottled Water Facilities:
The FFDCA also authorizes FDA to inspect bottled water facilities and
sample products. According to FDA, since bottled water has had a
relatively good safety record over the years, bottled water facilities
are generally assigned a low priority for inspection, unless a facility
has had violations in the past. On average, FDA has devoted
approximately 2.6 full-time-equivalent positions per fiscal year to
inspecting bottled water facilities in fiscal years 2000 through 2008.
Specific inspection tasks for bottled water facilities include (1)
verifying that the water used by the plant for its product and for its
operations are obtained from an approved source;[Footnote 12] (2)
checking whether bottled water labeling complies with FDA regulations;
(3) inspecting washing and sanitizing procedures; (4) inspecting
filling, capping, and sealing operations; and (5) determining whether
the firms analyze, on schedule, their source water and finished
products for the contaminants listed in the standard of quality and
whether the firms meet the standard of quality's allowable levels for
the contaminants. In general, inspectors take water samples only "for
cause" (i.e., if they observe a potential problem or if the facility
has a history of contamination).
We have found that the frequency of bottled water inspections varied.
Domestic bottled water inspections generally averaged about 475 per
fiscal year, but increased dramatically in fiscal years 2003 and 2005,
to about 600 and 740, respectively. According to FDA officials, the
increase in inspections in fiscal years 2003 and 2005 was most likely
due to an increased focus on ensuring the security of all food
facilities. Because FDA's database of registered food firms does not
capture data that would identify all U.S. firms manufacturing bottled
water, we could not determine the percentage of bottled water
facilities inspected. On the basis of interviews with FDA officials in
the eight district offices we contacted, however, inspections of
bottled water facilities took place at varying frequencies. For
example, three of the district offices with which we spoke stated that
bottled water facilities are inspected once every 2 to 3 years by the
district office or by the state under contract with FDA. Other district
offices reported inspecting bottled water facilities less often.
Additionally, FDA has increasingly relied on states to inspect bottled
water facilities. FDA establishes contracts with state agencies to
inspect particular facilities, including bottled water facilities.
State officials performing inspections as part of an FDA contract
perform inspections the same way that an FDA inspector would perform an
inspection. Like FDA inspectors, state-contracted inspectors do not
generally take samples, unless there is a reason to do so. States that
conduct contract inspections are audited by FDA district offices to
ensure that their inspections are equivalent to FDA inspections. Twenty-
two of the 26 states under the jurisdiction of seven of the eight
district offices we contacted conduct bottled water inspections under
contract with FDA.[Footnote 13] Our review indicates that from fiscal
years 2000 through 2008, the state share of bottled water inspections
has increased in recent years (see figure 1). From fiscal years 2000
through 2005, the states, under contract with FDA, conducted about 65
percent of the bottled water inspections, while from fiscal years 2006
through 2008, the states conducted about 86 percent of the bottled
water inspections. Overall, the states conducted approximately 70
percent of the bottled water inspections from fiscal years 2000 through
2008.
Figure 1: Bottled Water Facility Inspections Conducted by FDA and
States, Fiscal Years 2000 through 2008:
[Refer to PDF for image: vertical bar graph]
Fiscal year: 2000;
Inspections conducted by FDA: 94;
Inspections conducted by states: 188.
Fiscal year: 2001;
Inspections conducted by FDA: 132;
Inspections conducted by states: 285.
Fiscal year: 2002;
Inspections conducted by FDA: 89;
Inspections conducted by states: 303.
Fiscal year: 2003;
Inspections conducted by FDA: 296;
Inspections conducted by states: 312.
Fiscal year: 2004;
Inspections conducted by FDA: 185;
Inspections conducted by states: 343.
Fiscal year: 2005;
Inspections conducted by FDA: 303;
Inspections conducted by states: 434.
Fiscal year: 2006;
Inspections conducted by FDA: 82;
Inspections conducted by states: 346.
Fiscal year: 2007;
Inspections conducted by FDA: 45;
Inspections conducted by states: 367.
Fiscal year: 2008;
Inspections conducted by FDA: 56;
Inspections conducted by states: 412.
Source: GAO analysis of FDA data.
[End of figure]
Furthermore, FDA coordinates with states to better leverage inspection
resources. We found that all eight FDA district offices we contacted
obtained the results of inspections conducted by the states under
contract with FDA. Most states shared this information with FDA through
an electronic database, which also gave the states access to a food
firm's inspectional history. If any collected samples violated the
standard of quality, the states generally shared this information as
well, according to officials from the FDA district offices. Such
information-sharing, according to FDA officials, allows the agency to
leverage resources so that it can focus on more high-priority food
inspections and ensures that they have complete information on facility
inspections.
In contrast, we found that most of the FDA district offices we
contacted did not have agreements to obtain the results of bottled
water facility inspections that states conduct under their own
authority, not under contract with FDA. Still, all of the district
offices with which we spoke said that state officials would most likely
contact them if a serious problem at a bottled water facility surfaced
during a state inspection.
On the basis of inspections conducted by FDA and the states under
contract with FDA, potential problems were identified in approximately
35 percent of the bottled water inspections conducted between fiscal
years 2000 and 2008, but FDA took little enforcement action. A majority
of the bottled water facilities that were inspected and found to have
potential problems were designated as "voluntary action indicated,"
meaning the inspector found objectionable conditions, but the district
office determined that such objectionable conditions were not
sufficient enough to warrant any administrative or regulatory action by
FDA. Accordingly, the firms in those cases were left to take corrective
actions voluntarily. FDA also indicated that there were a small number
of cases in which FDA referred issues related to bottled water quality
to local public health authorities that have their own enforcement
authorities. On the basis of a review of FDA's food recalls database,
from fiscal years 2002 through 2008, bottled water has been recalled 23
times, primarily for excessive levels of contaminants, such as arsenic
and bromate. Also during this period, FDA issued three warning letters
to bottled water facilities for various violations, including failure
to maintain documentation and inadequate sanitary practices.
State Requirements for Bottled Water Often Exceed FDA's, but Are Still
Often Less Comprehensive Than State Requirements to Safeguard Tap
Water:
States have enacted their own laws and regulations in an effort to
better ensure the quality and safety of bottled water. Nonetheless, (1)
the laws and regulations are less consistent than state laws in
protecting tap water, pursuant to the Safe Drinking Water Act, and (2)
FDA does not have the statutory authority to oversee state regulation
of bottled water, while the Safe Drinking Water Act requires EPA to
oversee primacy states' regulation of tap water.
Our survey of 50 states and the District of Columbia identified
variability in their requirements in governing certain key practices
that protect and ensure bottled water quality and safety. For example,
respondents in 31 states indicated that their states require that
microbiological tests be done by a certified laboratory.[Footnote 14]
Respondents in 12 states, however, do not require the use of a
certified laboratory for such tests. States also exhibit variability in
terms of what they require of bottled water facilities in reporting the
results of quality tests to the state. For example, 21 respondents said
their states require bottlers to notify the states if they detect
violations in their samples, and 20 require bottlers to submit water
quality test results to the states on a periodic basis, whether or not
they are in violation.[Footnote 15] On the other hand, 20 states do not
require that water quality tests or violations be reported to the
state. Furthermore, states exhibited variability in the frequency at
which bottled water facilities are inspected. Officials from 38 states
reported that they inspected bottled water facilities annually or more
often, whereas officials from 10 states indicated that their states
inspected bottled water facilities less frequently than once a year.
In contrast to the diverse practices among state authorities in
regulating bottled water, the framework under the Safe Drinking Water
Act for regulating tap water requires a high degree of consistency
among the states. For example, one condition of being given primary
enforcement responsibilities (or primacy) for their public water
systems, is that states must have adopted and be implementing adequate
procedures for the enforcement of state drinking water regulations that
are no less stringent than EPA's national primary drinking water
regulations. Among other requirements, the adequate procedures must
include the following: (1) statutory or regulatory enforcement
authority adequate to compel compliance, (2) maintenance of an
inventory of public water systems operating in the state, (3) a
systematic program for conducting sanitary surveys of public water
systems, and (4) a program for the certification of laboratories
conducting analytical measurements of drinking water contaminants.
The FFDCA and the Safe Drinking Water Act also require different levels
of federal oversight. Specifically, under the Safe Drinking Water Act,
states may be given primary responsibility for regulating drinking
water with EPA conducting systematic oversight, whereas FDA retains
responsibility for regulating bottled water under the FFDCA. At least
annually, for example, EPA must review a state's compliance with
requirements for having primary enforcement responsibility. If the
states do not meet these requirements, EPA must initiate proceedings to
withdraw primacy approval. In addition, primacy states must submit
quarterly reports to EPA that include both new violations of national
primary drinking water regulations and new enforcement actions that
states took against public water systems for those violations. In
contrast, FDA does not have the statutory authority to grant states
responsibility for bottled water regulation, nor does it have statutory
authority to review state bottled water regulations or the enforcement
actions taken by the states.
FDA's Oversight of Imported Bottled Water Is Limited:
FDA has provided limited oversight of imported bottled water, since
relatively few bottled water imports are physically examined or
sampled. The agency follows a two-tier strategy to oversee the
importation of bottled water and the importation of food in general.
First, FDA's Prior Notice Center reviews information about scheduled
food imports to determine whether there are any terrorism-related
concerns or serious health risks associated with the products. Second,
after the information pertaining to the articles offered for import is
transmitted to U.S. Customs and Border Protection in the form of an
entry, data pertaining to FDA are sent to an automated database, where
they are screened. At this point in the process, the entry data are
evaluated electronically and either are allowed to proceed or are
flagged for review. To determine whether an article offered for import
warrants further examination, reviewers are to take into account the
perceived risk and whether an import alert has been issued for the
particular commodity, importer, or country of origin. Since 2004, only
one import alert has been associated with bottled water.[Footnote 16]
The entry reviewer can request entry documentation pertaining to the
product, review the product label, and request that the product be
examined or sampled. If the agency finds a problem with an import--for
example, contamination--the shipment is detained while the importer or
agent is given a period of time to present exonerating evidence. If the
importer or agent cannot provide evidence to overcome the apparent
violation within the 10-day detention and hearing period, barring any
extensions, the shipment is refused. After a refusal is issued, the
importer must either destroy or export the article out of the United
States within 90 days. FDA also examines other articles offered for
import as part of general surveillance to meet its work plan. For
example, FDA increased its review of bottled water imports as a result
of the events of September 11, 2001.
Our review of data from FDA's imports database indicates that FDA's
oversight of imported bottled water has been limited. From fiscal years
2004 through 2008, there were 263,314 import entry lines[Footnote 17]
associated with either bottled water or bottled spring or mineral
water. Of these, approximately 50 percent of the bottled spring or
mineral water and 33 percent of the bottled water were permitted to
proceed without further review, while the remainder was subject to an
on-screen review. Of the imports reviewed on screen, about 1 percent of
the bottled spring or mineral water and about 4 percent of the bottled
water were examined further. A smaller percentage of the bottled water
imports was sampled for quality testing.
In addition to reviewing FDA's responsibilities for ensuring the
quality and safety of bottled water imports, we also reviewed how
several top exporting countries--including Canada, Fiji, and Turkey as
well as the European Union and its member states--regulate bottled
water. We found that, like the United States, these countries have
established definitions for different types of bottled water and water
quality standards to ensure safety. We identified a couple of examples
in which foreign regulations are more stringent than FDA regulations.
For example, Canadian regulations specify that bottled water cannot
contain any coliform bacteria. In addition, Turkey requires that
inspections of bottled water facilities be conducted more frequently
than FDA requires. Specifically, licensed drinking water facilities are
subject to inspections annually by the Ministry of Health and every 3
months by the local health authority. Licensed natural mineral waters
are subject to inspections every 3 months by the ministry and every
month by the local health authority. Manufacturers are responsible for
the costs of the ministry's and local health authority's analyses of
bottled water.
FDA's Oversight of Bottled Water Is Limited by its Authority under the
FFDCA and Its Resource Constraints:
A number of concerns emerge regarding FDA's regulation of bottled water
under the FFDCA and its enforcement practices, particularly in
comparison with EPA's regulation of drinking water under the Safe
Drinking Water Act. These observations, however, should be viewed in
the context of the legal limitations placed by the FFDCA on FDA, and
the constrained resources that have affected FDA's overall capabilities
in recent years. The legal constraints 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 opposed to drinking water subject
to the Safe Drinking Water Act--and does not specifically authorize FDA
to require that foods, including 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 18] 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 19] 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. Along those same lines, we noted in 2005
[Footnote 20] that while FDA was responsible for regulating about 80
percent of the nation's food supply, it accounted for only 24 percent
of expenditures in fiscal year 2003 among the federal agencies with
food-safety-related responsibilities (these other agencies included the
U.S. Department of Agriculture, EPA, and the National Marine Fisheries
Service).
In light of its resource constraints, FDA's Food Protection Plan,
issued in 2007,[Footnote 21] cites the need to focus general food
safety inspections based on risk. In addition, although not yet fully
defined, FDA has indeed begun to take a more risk-based approach in
identifying firms for safety inspections and has identified bottled
water to be a low-risk food product. The result of this approach,
therefore, has led FDA to devote fewer resources to bottled water
oversight for general food safety because of a need to focus on higher-
risk food products, such as seafood and fresh produce.
Ultimately, as we recommended in 2007,[Footnote 22] a fundamental
reexamination of the federal food safety system will be needed to look
across the activities of individual programs within specific agencies
with food-safety-related responsibilities. Toward that end, in 2001 we
recommended, among other things, that Congress 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
23] We believe that FDA's lack of authority and resources to
effectively regulate bottled water, as compared with how EPA regulates
tap water, should be part of that reexamination.
FDA and State Bottled Water Labeling Requirements Resemble Those for
Other Food Types, but Demand Less Information Than Is Required for Tap
Water:
FDA Regulations Require Bottled Water Labels to Contain Specific
Information, in Addition to Information Required for All Food Products:
Because it is considered a food, bottled water must comply with FDA's
general requirements for food labeling,[Footnote 24] which include
ingredient and nutrition information. These requirements include the
name of the product; the name and address of the manufacturer, packer,
or distributor; and the net contents. Although not required, bottled
water labels may also include the type of water (i.e., standard of
identity). In addition, like other food products, bottled water is
subject to the same general prohibitions against misbranding.
Responding to a petition from IBWA for FDA to more closely regulate
bottled water in the face of inconsistent state regulation of bottled
water, FDA in 1995, modified and expanded the standard of identity
regulation, including definitions for different types of bottled water,
such as mineral water and spring water (see table 1). According to FDA
regulations, if a bottled water label includes a standard of identity,
the water must satisfy that standard's requirements or the product will
be considered misbranded. For example, bottled water labeled as mineral
water must, among other things, contain not less than 250 parts per
million of total dissolved solids and originate from a geologically and
physically protected underground water source, with no minerals
artificially added. For bottled water that comes from a public water
system, the standard of identity regulations require its label to
clearly state that the product comes from a municipal source or
community water system, unless the water has been treated and meets the
standard of identity for purified, distilled, deionized, sterile, or
sterilized water. Carbonated water, soda water, seltzer water,
sparkling water, and tonic water are considered soft drinks and are not
regulated as bottled water. In addition, other terms used on the label
about the source, such as "glacier water" or "mountain water," are not
definitions included in the standard of identity regulation and may not
be used to convey that the water comes from a pristine area.
Table 1: Types of Bottled Water Under the Standard of Identity
Regulation:
Type: Artesian water or artesian well water;
Definition: Water from a well tapping a confined aquifer in which the
water level stands at some height above the top of the aquifer.
Type: Groundwater;
Definition: Water from a subsurface saturated zone that is under a
pressure equal to or greater than atmospheric pressure but not under
the influence of surface water (water open to the atmosphere).
Type: Mineral water;
Definition: Water containing not less than 250 parts per million of
total dissolved solids, coming from a source tapped at one or more
boreholes or springs, originating from a geologically and physically
protected underground water source. Mineral water has a constant level
and relative proportions of minerals and trace elements when it emerges
from the source. No minerals may be added.
Type: Purified or demineralized water;
Definition: Water that has been produced by distillation, deionization,
reverse osmosis, or other suitable processes that meets the definition
of "purified water" in U.S. Pharmacopeia, 23rd revision. Purified water
is essentially free of all chemicals (it must not contain more than 10
parts per million of total dissolved solids) and may also be free of
microbes if treated by distillation or reverse osmosis. Purified water
may alternatively be labeled according to how it is treated, for
example, deionized water, distilled water, or reverse osmosis water. In
addition, these processes can modify the term drinking water (i.e.,
purified drinking water).
Type: Sparkling bottled water;
Definition: Water that, after treatment and possible replacement of
carbon dioxide, contains the same amount of carbon dioxide from the
source that it had at emergence from the source.
Type: Spring water;
Definition: Water derived from an underground formation from which
water flows naturally to the surface of the earth. Spring water can be
collected only at the spring or through a borehole tapping the
underground formation feeding the spring. There must be a natural force
causing the water to flow to the surface through a natural orifice. If
a borehole and external force are used to collect the spring water,
additional requirements are imposed. The location of the spring must be
identified.
Type: Sterile or sterilized water;
Definition: Water that meets the requirements under "Sterility Tests,"
U.S. Pharmacopeia, 23rd revision. Sterilized water is free from all
microbes.
Type: Well water;
Definition: Water from a hole bored, drilled, or otherwise constructed
in the ground which taps the water of an aquifer.
Source: 21 C.F.R. § 165.110(a).
[End of table]
As with other foods, FDA guidance provides that when inspecting bottled
water facilities, investigators should review labels to ensure that
they are accurate and meet regulations. As we have previously
mentioned,[Footnote 25] however, FDA often has limited assurance that
companies are complying with food-labeling requirements, partly because
FDA investigators are not required to keep track of labels reviewed.
Therefore, in the absence of reliable FDA data, we were not able to
determine the extent to which FDA reviews bottled water labels, or to
substantiate the claims of FDA officials that they have not come across
any widespread problems with bottled water labeling. Our own review of
bottled water labels revealed that the information they contain--
although limited--is generally accurate. Specifically, of the 83 labels
we reviewed from across the country, only 1 included an unclear
statement on the label regarding the standard of identity. In this
case, the label listed the water as "mountain spring water" but after
contacting the company, we determined that the water was actually
artesian and not spring water as defined by FDA. The real question,
however, is whether the label information is sufficient to adequately
inform consumers about a water bottle's contents. As we discuss in the
following section, the actions of a number of states, and our own
review, suggest that consumers could benefit from additional
information.
Many States Have Adopted FDA's Labeling Regulations, but Some States
Require That Labels Contain Additional Information:
Many states have adopted FDA's labeling regulations, but some states
require additional information. For example, bottled water sold in New
Mexico must be labeled with the treatment methods used in its
production. Also, bottled water sold in Massachusetts is required to
include information on the label identifying the type and the location
of the source water (by municipality, state, or country). Massachusetts
state officials said this requirement was put in place because of
strong consumer demand for such information. Some states have also
established further restrictions regarding source listings. For
example, Alaska defines "glacier water" as either (1) runoff directly
from the natural melting of a glacier, (2) water obtained from the
melting of glacial ice at a food-processing establishment, or (3) water
from a stream flowing directly from a glacier and not diluted or
influenced by a nonglacial stream.
As a related matter, California recently passed legislation requiring
that, as a condition of being licensed in the state, a bottled water
facility must annually prepare a bottled water report and make the
report available to each customer upon request. The report must
include, among other things, information on the source, treatment
method, and health disclosures for certain contaminants that may be
found in the water. According to California state officials, this
legislation was passed to require that this information be made
available so that the state's consumers are afforded the same water
quality "right-to-know" protections and regulatory oversight of bottled
water as those established for tap water. Labels on bottled water from
facilities licensed in California are now required to include a
statement about how consumers can access the annual report.
Such consumer right-to-know reports have been required by EPA for
public water systems since 1998. These "consumer confidence reports"
summarize information on sources, on any detected contaminants, and on
compliance with primary drinking water regulations, among other
information. Consumer confidence reports are one of several right-to-
know provisions that were included in the Safe Drinking Water Act
Amendments of 1996. These amendments contain several other provisions
to improve public information about drinking water, including requiring
public notification when a public water system fails to meet a maximum
contaminant level.
FDA Identified Methods to Better Inform Customers about the Contents of
Bottled Water, but Was Not Required to Implement Them:
The Safe Drinking Water Act Amendments also required FDA to study the
feasibility of the appropriate methods to inform customers about the
contents of bottled water. In its 2000 report,[Footnote 26] FDA
concluded that certain methods were feasible for the bottled water
industry to provide the same type of information to consumers that the
Safe Drinking Water Act requires public water systems to provide in an
annual consumer confidence report--including the source and levels of
contaminants tested for and found in the water.[Footnote 27] FDA
further concluded that it would be feasible and appropriate for the
industry to update the information annually and provide it by enabling
the consumer to contact the producer directly through a telephone
number or address listed on the label, or through a combined approach
where some information about the water would be included on the label
and the rest would be obtainable on request. Nonetheless, the agency
was not required to take action on its findings and has yet to do so.
FDA officials explained that since bottled water is not considered a
significant health risk, and, in light of the agency's limited
available resources, FDA does not anticipate initiating a rule making
in response to the study's findings.
Additional Information about Bottled Water Would Be Beneficial to
Consumers:
Our work suggests that consumers may benefit from additional
information. For example, when asked whether consumers in their state
had misconceptions about bottled water, 24 of the 51 state and District
of Columbia officials responding to our survey replied that consumers
believe that bottled water is safer, is healthier, or is of higher
quality 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. In a separate poll, the Water Research Foundation, in
2003, found that about 56 percent of the bottled water drinkers cited
safety and health as the primary reason they sought an alternative to
tap water.
IBWA has also endorsed the concept that a consumer has a right to
comprehensive information about bottled water, believing that the most
feasible way for consumers to obtain this information is through a
request to the bottler. In fact, IBWA requires that its members include
a telephone number on their labels so consumers can contact the company
and request information that should be readily available to the
company.
Nonetheless, our review of bottled water labels revealed that, when
compared with what public water systems are required to provide to
consumers of tap water, very few bottled water facilities provide such
information to consumers, either through labels, company Web sites,
telephone calls to company representatives, or any combination of these
avenues. Of the 83 bottled water labels that we reviewed, 9 did not
have contact information, such as a telephone number, Web address, or e-
mail; 5 labels had only a postal address as a means of contacting the
company. Bottled water labels for 12 brands did not contain source
information, nor was this information available by telephone or a Web
site review. In addition, 16 brands did not contain water quality
treatment information on the label, nor was this information available
by telephone or a Web site review. Furthermore, only 1 of the bottled
water labels that we reviewed contained limited water quality or health-
related information, and this information was available from just 34 of
the bottled water companies that we had telephoned or from reviewing
their Web site. Thirteen of the water quality reports that we did
obtain were incomplete or unclear. For example, several of the water
quality reports had test results for only some of the contaminants
tested or did not reflect the most recent tests conducted; other
reports only described which contaminants were tested or how often the
tests were conducted.
Production and Consumption of Bottled Water Has Varied Impacts on the
Environment:
In addition to the safety and consumer issues associated with bottled
water, some parties have raised concerns about the environmental
impacts associated with its manufacture and transportation and with the
extraction of water associated with its production. Among these issues
are the impacts on (1) municipal landfill capacity of discarded water
bottles, (2) the effects on U.S. energy demands from the manufacture
and transport of plastic bottles for drinking water, and (3)
communities and the environment of groundwater extraction for the
purposes of bottling water.
Most Plastic Water Bottle Containers Are Discarded Rather Than
Recycled, Although They Appear to Have a Minimal Impact on the Nation's
Municipal Landfill Capacity:
Most plastic water bottles produced in the United States are discarded
rather than recycled. The most common water bottles are made of a
plastic called polyethylene terephthalate, or PET.[Footnote 28] Precise
information on the amount of PET in the bottled water containers
produced, recycled, and discarded each year is not available.
Representatives of the beverage industry and an environmental nonprofit
organization reported that about 827,000 to 1.3 million tons of PET
plastic water bottle containers were produced in the United States in
2006. Our analysis of data provided by these groups indicated that
about 76.5 percent of these PET plastic water bottles were discarded in
2006, which is equivalent to about 632,655 to 999,001 tons of PET, or
less than about 1 percent of the 170 million tons of the total
discarded U.S. municipal solid waste and about 26 to 41 percent of the
2.4 million tons of total discarded PET plastic. Most discarded water
bottles end up in U.S. landfills, although some bottles become litter
or are incinerated, according to the officials with whom we spoke.
Precise information was not available regarding the amount of discarded
PET water bottles that ended up in U.S. landfills versus discarded PET
water bottles that were incinerated or became litter.
The near-term impact of the PET plastic water bottles in municipal
landfills appears to be minimal. For example, an official from EPA's
Office of Resource Conservation and Recovery and an expert in solid
waste management from the Solid Waste Association of North American
told us that PET plastic is an inert material and, therefore, does not
react when in contact with other materials in the waste stream. They
also noted that PET plastic is not known to leach contaminants, nor is
it associated with any known risks to public health or the environment
while in a landfill. However, they emphasized that in a landfill, PET
plastic water bottle containers are typically compacted and shielded
from the sunlight and the atmosphere. According to the solid waste
management expert, under these conditions it is not known precisely how
long it takes for the PET plastic to decompose, although decomposition
will occur over a very long time horizon, possibly thousands of years.
Thus, this expert told us that for landfill management purposes, solid
waste experts assume that PET plastic will never decompose.
Knowledgeable officials from the beverage and PET plastic-manufacturing
industries told us that bottled water companies have made significant
investments in recent years to "light-weight," or reduce the amount of
PET plastic in each bottle. For example, Nestlé Waters North America
reported in its 2008 Corporate Citizenship Report that it introduced a
12.4 gram half-liter PET water bottle on the market in 2008 that
reduced the amount of PET plastic in its half-liter bottles by 30
percent, compared with the average half-liter plastic beverage
container on the market in the previous year. These officials believed
that these efforts will lead to substantial reductions over the next
few years in the amount of PET plastic associated with discarded water
bottles. It is unclear what impact efforts to produce bottles with less
plastic will have on the total amount of PET plastic associated with
discarded water bottles until more municipal solid waste statistics
become available.
Manufacture and Transportation of Bottled Water Is Considerably More
Energy-Intensive Than for Tap Water, and the Energy Costs Vary
Substantially:
We identified two organizations that have attempted to document the
effects on U.S. energy demands of the manufacture and transportation of
bottled water. Among the analyses we reviewed, the most comprehensive
was a peer-reviewed study published in February 2009 by the Pacific
Institute that computed the energy required for various phases of
bottled water production, transport, and use.[Footnote 29]
Specifically, the institute computed the energy required to make PET
plastic material, to fabricate the bottles using the PET material,
process the water before bottling, fill and seal the bottle, transport
the bottled water for sale to end-users, and chill it for use. Because
transportation energy costs can vary, depending on the distance from a
bottling plant to market and the mode of transportation, the institute
evaluated the energy costs for the following three transportation
scenarios for transporting filled water bottles from a bottling plant
to a point of sale in Los Angeles, California: (1) locally produced
purified bottled water, delivered within 200 kilometers (about 125
miles) of a bottling plant by truck; (2) spring water transported from
the island nation of Fiji in the South Pacific by cargo ship to Los
Angeles and then delivered locally within 100 kilometers (about 60
miles); and (3) spring water transported from France by cargo ship to
the eastern United States, transported by freight rail to Los Angeles,
and distributed locally by truck. The results of these three scenarios
apply to water shipped from the three locations and consumed in Los
Angeles and, therefore, are not representative of all U.S.
transportation of bottled water from the bottling plant to the point of
sale. According to Pacific Institute officials, these scenarios were
chosen to try to provide a low, medium, and high range for energy costs
associated with the manufacture and transportation of bottled water.
Although the Pacific Institute's study was the most comprehensive
analysis of the energy impacts of bottled water that we identified,
certain aspects of its scope and methodology limit the generalizability
and certainty of its results. For example, the scope of the institute's
study did not include energy estimates for all phases of bottled water
production and use, such as the energy required to transport or convey
the water to the bottling plant from either a municipal source or a
self-supplied surface or groundwater source, nor did the study include
the energy required for bottled water waste collection, disposal, and
recycling. In addition, the institute's analysis and results focused on
the energy required for the production, transport, and use of a typical
1-liter PET bottle of water, which the institute estimated weighs about
38 grams. Lighter and heavier PET bottles could have significantly
different energy impacts.
The Pacific Institute's study presented two major findings. First, the
energy required to produce and use a typical 1-liter PET bottle of
water weighing 38 grams varies substantially, depending on the mode of
transportation and the distances traveled from the bottling plant to
the point of sale. For example, the institute estimated that
transportation energy costs varied from about 25 percent (1.4
megajoules per liter)[Footnote 30] of the total energy footprint for
"purified" bottled water produced in Los Angeles and delivered locally
within 200 kilometers (about 125 miles) of the bottling plant by truck,
to about 57 percent (5.8 megajoules per liter) for "spring" water
bottled in France, transported overseas by cargo ship, and transported
by rail from the eastern United States to Los Angeles. Second, although
the overall production and consumption of bottled water makes up a
small share of the total U.S. energy demand, bottled water is much more
energy-intensive than public drinking water. For example, on the basis
of all the energy inputs for bottled water manufacture and use and the
three transportation scenarios calculated, the institute estimated that
the total energy required to bring a typical 1-liter PET bottle of
water weighing about 38 grams to the consumer in Los Angeles would
typically range from about 5.8 to about 10.2 megajoules per liter, or
about 1,100 to 2,000 times the energy cost of producing tap water
(about 0.005 megajoules per liter).[Footnote 31]
Groundwater Extraction for Bottled Water Is Small Relative to
Groundwater Withdrawals for Other Uses, but Can Have Noticeable
Localized Impacts:
According to state officials in Maine, Michigan, New Hampshire, and
Vermont, existing groundwater extraction for the purposes of bottled
water has not had an adverse impact on state waters or the environment
and is small relative to other groundwater uses. However, these
officials said that large-scale groundwater extraction can adversely
impact local groundwater availability, surface water flows, and
dependent resources. We chose to speak with officials in these four
states about the impacts of groundwater extraction because in each of
these states, local communities have expressed concerns about bottled
water production, and recent state legislation was enacted to address
these concerns. Among the cases we reviewed, we found that such concern
centered on water extracted from a groundwater source by the bottled
water producer, rather than water purchased from a municipal source.
State officials told us that existing groundwater extraction for
bottled water does not have a significant impact on state groundwater
supplies. For example, state officials in Maine told us that in 2007,
bottled water production constituted about 3 percent (or 650 million
gallons) of the 19 billion gallons of total groundwater extracted in
the state. Similarly, officials from the four states told us that
existing groundwater withdrawals for bottled water are small relative
to other groundwater uses. For example, a geologist from the New
Hampshire Department of Environmental Services reported that most
groundwater extraction in the state goes to municipal water systems,
residential subdivisions, golf courses, power plants, and manufacturers
of beverages other than bottled water. In addition, Michigan state
officials told us that in areas of Michigan where groundwater can be
limited, most groundwater extraction goes to agricultural and mining
activities.
While groundwater extraction may have minimal impacts on state
groundwater supplies, it can, in some cases, alter local groundwater
levels and flows to nearby surface waters, according to the U.S.
Geological Survey.[Footnote 32] For example, pumping groundwater from a
single well diverts the groundwater toward the extraction well in the
area around the well. As a result, pumping can lower the local water
table shared by nearby well users. When the aquifer is shallow and
connected to a nearby stream, the pumping can diminish the available
surface water supply by diverting some of the groundwater that
otherwise would have flowed into the stream or by drawing flow from the
stream into the surrounding aquifer. Reductions of surface water flows
as a result of groundwater extraction are likely to be of greatest
concern during periods of low flow. Groundwater extraction can also
affect natural resources dependent on groundwater flowing to surface
waters. For example, changes in the water that flows to and from a
stream may affect temperature, oxygen levels, and nutrient
concentrations in the stream. These changes may in turn affect aquatic
life, such as certain fish populations whose spawning success may be
greater where surface water temperature is modulated by incoming
groundwater. The impacts from a single groundwater extraction site on
local ground and surface waters depend on factors that include, among
other things, the rate of water withdrawals, type and physical
characteristics of an aquifer, degree of connection between the aquifer
and surface waters, and rates of precipitation.
The state officials we interviewed told us that while they have not
seen adverse large-scale impacts on water supplies and the environment
from existing bottled-water-related groundwater extraction, concerns
among some local communities in these states about their effect have
led to some conflict and litigation.[Footnote 33] For example, in 2001
residents in Mecosta County, Michigan, sued a water bottler, alleging
that its withdrawals reduced water levels of a nearby stream and
wetlands and unlawfully interfered with their water rights.[Footnote
34]
State officials in Michigan, Maine, and Vermont told us that to address
these concerns and ensure that effective groundwater resource
protections were in place, their state legislatures enacted new or
amended requirements for extracting groundwater for bottled water. For
example, in 2006 and 2008, Michigan's safe drinking water act was
amended to require, among other things, a permit for a water-bottling
operation that uses a new or increased groundwater withdrawal of more
than 200,000 gallons per day. The law also requires that permitted
groundwater withdrawals of more than 2 million gallons per day do not
result in an individual or cumulative adverse impact, which refers to
decreasing a stream's or river's flow or reducing the abundance or
density of fish populations.
Conclusions:
While FDA's standard of quality regulations for bottled water are
generally consistent with EPA's drinking water quality requirements,
the agency could do more to ensure the safety of bottled water, either
by (1) promptly adopting EPA's health-based public drinking water
standard for the phthalate, DEHP, and setting monitoring requirements
for this contaminant or (2) publishing in the Federal Register a
rationale for not doing so. We further believe FDA should act
expeditiously after its DEHP task force study ends, since FDA's
statutory deadline for acting on DEHP was more than 15 years ago.
Without a standard or monitoring requirement in place, bottled water
facilities are not required to test for and potentially identify
harmful levels of a contaminant that is currently regulated in public
drinking water. In addition, to prevent public misconceptions about the
health and safety of bottled water and to match consumer right-to-know
standards pertaining to tap water, FDA could help to ensure that
consumers have more complete product information by implementing its
findings regarding the appropriate and feasible methods for informing
consumers about the contents of bottled water.
Although we have also raised a number of broader concerns about FDA's
oversight of bottled water facilities--particularly in comparison with
EPA's regulation of public water supply systems under the Safe Drinking
Water Act--we acknowledge that many of these concerns reflect the legal
limitations the FFDCA imposes on the agency and the decline in
resources that has hampered overall food safety responsibilities in
recent years. Regarding FDA's effectiveness, we have recommended in the
past that a fundamental reexamination of the federal food safety system
be undertaken, including enactment of comprehensive, uniform, risk-
based food safety legislation. We believe that FDA's lack of authority
and resources to effectively regulate bottled water should be part of
this reexamination.
Recommendations for Executive Action:
We recommend that the Secretary of Health and Human Services direct the
Commissioner of FDA to take the following two steps:
* 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 this matter.
* Implement FDA's findings on methods that are feasible for conveying
information about bottled water to customers, such as, at a minimum,
requiring that companies provide on the label contact information
directing customers on how to obtain comprehensive information. Should
FDA determine that it lacks the necessary authority to implement its
findings, it should seek legislation to obtain such authority.
Agency Comments and Our Evaluation:
We provided the Environmental Protection Agency and the Department of
Health and Human Services' Food and Drug Administration with a draft of
this report for their review and comment. EPA provided oral comments,
stating that the agency agreed with the report's findings. In its
written response, FDA first noted that the agency "strives continually
to advance its public health mission, and this includes efforts to
improve the safety, sanitation, suitability, and proper labeling of
bottled water." It then expressed general agreement with our two
recommendations. Regarding the first recommendation on issuing a
standard of quality regulation for DEHP in bottled water, FDA agreed
that it should reassess whether to issue the regulation as soon as
possible after the conclusion of the task force study on phthalates.
However, FDA noted that our recommended 180-day time frame to issue a
DEHP standard for bottled water did not provide enough time for a
notice and comment rule making. Accordingly, we changed the time frame
in the recommendation from 180 days to 1 year. In the event that FDA
decides to promulgate a standard of quality regulation for DEHP, we
think that 1 year provides FDA with sufficient time to conduct rule
making since it will be based on the study's results. Moreover, we
think FDA should move expeditiously on DEHP since the statutory
deadline for taking action was more than 15 years ago. Regarding our
recommendation to improve the way in which information about bottled
water is conveyed to consumers, FDA agreed that bottled water should be
labeled with contact information that allows consumers to more easily
contact the manufacturer to obtain comprehensive information about the
product. The agency said it intends to pursue this issue with bottled
water manufacturers. FDA also provided comments to improve the draft
report's technical accuracy, which we have incorporated as appropriate.
Appendix IV contains a reprint of FDA's letter.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time, we will send copies of this report
to the appropriate congressional committees, the Secretary of Health
and Human Services, the Commissioner of the Food and Drug
Administration, the Administrator of the Environmental Protection
Agency, and other interested parties. The report also will be available
at no charge on the GAO Web site at [hyperlink, http://www.gao.gov].
If you or your staff members have any questions about this report,
please contact me at (202) 512-3841 or stephensonj@gao.gov. Contact
points for our Offices of Congressional Relations and Public Affairs
may be found on the last page of this report. GAO staff who made major
contributions to this report are listed in appendix V.
[Signed by:
John B. Stephenson:
Director, Natural Resources and Environment:
[End of section]
Appendix I: Scope and Methodology:
To evaluate the extent to which federal and state authorities regulate
the quality of bottled water to ensure it is safe and the extent to
which they regulate the accuracy of labels or claims about the purity
and source of bottled water, we reviewed federal and state bottled
water regulations. We compared the standard of quality regulations that
apply to bottled water with the Environmental Protection Agency‘s (EPA)
standards under the Safe Drinking Water Act. We interviewed officials
in the Food and Drug Administration‘s (FDA) Center for Food Safety and
Nutrition, Office of Regulatory Affairs, and eight FDA District
Offices, among other FDA offices; EPA; nonprofit organizations, such as
the Natural Resources Defense Council, the Environmental Working Group,
and the Food and Water Watch; and the International Bottled Water
Association (IBWA). Our definition of ’bottled water“ in this report
includes any food product that meets FDA‘s standard of identity for
bottled water. We did not conduct water quality analyses of bottled
water to determine if the product met the standard of quality. We also
did not conduct a systematic review of source water approval or testing
records at bottled water facilities.
We also researched bottled water laws and regulations in the 50 states
and the District of Columbia. We selected 10 states[Footnote 35] for in-
depth reviews because their standard of quality, testing requirements,
or both, differed from FDA standards and from 1 state that adopted FDA‘
s requirements.[Footnote 36] To learn more about state regulations and
enforcement policies, we held interviews by telephone with regulatory
officials in 8 of the 10 states, in person with Ohio and Massachusetts
officials, and in writing with Wisconsin officials. On the basis of
these discussions, we developed a briefer set of questions on
implementing and enforcing bottled water regulations. After we drafted
this questionnaire, we asked for comments from state officials in 4 of
the 10 states selected for in-depth review. We conducted these pretests
to check that (1) questions were clear and unambiguous, (2) terminology
was used correctly, (3) the information could be feasibly obtained, and
(4) the survey was comprehensive and unbiased. Three of the four
pretests were administered over the telephone.
Next, we administered our survey by telephone to state officials
responsible for bottled water oversight in all of the remaining states
and the District of Columbia. (Appendix III shows the questions that we
asked and a summary of the responses that we received.) We made the
telephone calls in December 2008 and January 2009. All states responded
to our questions. Some state officials were unable to answer all of the
questions during our first call; they subsequently provided the
information later via telephone or e-mail.
We also examined bottled water labels and contacted companies to
determine the information they provide consumers about the source,
treatment, and quality of their products. We did not evaluate whether
label information was false or misleading. To obtain bottled water
labels, we asked GAO staff in each of our 11 field offices and at
headquarters to collect about 10 labels per office from bottled water
that is specific or unique to their region.[Footnote 37] After removing
duplicate bottled water labels and labels that were not for bottled
water but for some other beverage, such as ’electrolyte-enhanced“
waters, we were left with 83 labels for bottled water sold in
containers ranging in size from 8 ounces to 1 gallon. This sample does
not represent the universe of bottled water available to consumers in
the United States. We systematically reviewed the labels and recorded
whether contact information was provided”such as a telephone number,
Web address, e-mail, or complete postal address”that would allow a
consumer to contact the bottled water company and readily obtain more
information about the product than what is listed on the label. We also
recorded whether the source of the water, treatment method, and any
quality test results were included on the label, or whether this
information was available by accessing the company‘s Web site or by
telephoning the company. We used the Web addresses and telephone
numbers listed on the label, if available. We contacted 61 companies by
telephone and conducted Web site reviews for 47 companies.
To determine how authorities in other countries ensure the safety of
bottled water, we reviewed how several top exporting countries”
including Canada, Fiji, and Turkey as well as the European Union and
its member states”regulate bottled water. We were not able to review
the laws in all of the top 10 exporting countries because information in
English was limited. In addition, we reviewed only the legal
requirements in these countries; we were not able to assess how the
laws are implemented or enforced.
We also analyzed data from FDA databases that track domestic and
foreign inspections, import examinations, and recalls. Regarding FDA
inspections of domestic and foreign bottled water facilities, as well
domestic inspections conducted by states under contract with FDA, we
analyzed data from the Field Accomplishments and Compliance Tracking
System for fiscal years 2000 through 2008. Regarding FDA reviews of
bottled water imports, we analyzed data from the Operational and
Administrative System for Import Support for fiscal years 2004 through
2008. In addition, we worked with FDA to obtain all warning letters
that had been issued to bottled water facilities for fiscal years 2002
through 2008. Finally, we analyzed data from FDA‘s Recall Enterprise
System for recalls that were issued for bottled water from November
2002 (when the system began) through fiscal year 2008. We assessed the
reliability of these data and found them to be sufficiently reliable
for our purposes. To assess the reliability of these data, we reviewed
related documentation and worked closely with agency officials to
identify any data problems. Because of the variance in how bottled
water and other beverages are coded as a product in the Field
Accomplishments and Compliance Tracking System, some of our analysis
regarding inspections may include other beverage or product types, such
as ice or flavored waters. However, our conversations with FDA
officials indicated very few entries included these other beverage or
product types.
To identify the environmental and other impacts of bottled water, we
reviewed the following three subtopics: (1) the impact of discarded
water bottles on municipal landfill capacity; (2) the effects on U.S.
energy demands from the manufacture and transport of plastic bottles
for drinking water; and (3) the impacts, if any, on communities and the
environment of groundwater extraction for the purposes of bottling
water.
To address the impact of discarded water bottles on municipal landfill
capacity, we interviewed knowledgeable officials from the American
Beverage Association and its consultant, Northbridge Environmental
Management; the Container Recycling Institute; IBWA; and the National
Association of PET Container Resources to obtain information on the
quantities of PET plastic water bottles[Footnote 38] that are produced
and recycled. We did not independently verify the accuracy and
completeness of the data provided by these organizations. Using figures
provided to us byAmerican Beverage Association and the Container
Recycling Institute for the amount of PET plastic water bottle
containers produced in 2006”the most recent year for which data were
available”and for the national recycling rate in 2006 for all PET
containers, provided to us by the National Association of PET Container
Resources, we calculated a range of estimates for the quantity of PET
plastic water bottles that were discarded in that year. We used these
data and figures from EPA‘s 2006 national municipal solid waste
characterization to calculate how much discarded PET water bottles
comprised as a share of the total discarded PET plastic and total
discarded municipal solid waste in the United States. To assess the
accuracy and completeness of EPA‘s municipal solid waste
characterization data, we reviewed EPA documentation and interviewed
knowledgeable officials from the EPA contractor Franklin Associates (a
division of the Eastern Research Group), which prepared the agency‘s
2006 national municipal solid waste characterization, Northbridge
Environmental Management, and the Solid Waste Association of North
America. Finally, we interviewed EPA officials from the Office of
Resource Conservation and Recovery and the Director of the Applied
Research Foundation of the Solid Waste Association of North America to
collect information regarding the impacts of discarded PET plastic
water bottle containers in landfills.
To identify the effects on U.S. energy demands of the manufacture and
transport of bottled water, we interviewed officials from EPA‘s Office
of Solid Waste and knowledgeable officials from three nonprofit
environmental organizations”the Earth Policy Institute, Food and Water
Watch, and the Pacific Institute. We identified two studies that
focused specifically on bottled drinking water, one by the Earth Policy
Institute and a second by the Pacific Institute. We reviewed the scope
and methodology of these studies and selected the Pacific Institute‘s
study for more in-depth evaluation because it was more comprehensive
and documented in a peer-reviewed article.[Footnote 39] Specifically,
we assessed the Pacific Institute‘s methodology to determine its
validity and summarized the studies‘ key findings relevant to our
objective.
To identify the impacts, if any, on communities and the environment of
groundwater extraction for bottling water, we reviewed and synthesized
information published by the U.S. Geological Survey about the impact of
groundwater extraction on aquifers, surface waters, and dependent
natural resources. We reviewed newspaper articles, books, journal
articles, and public policy reports to identify states where conflicts
or litigation over groundwater extraction have taken place. Among the
states identified, we selected Maine, Michigan, New Hampshire, and
Vermont for more in-depth review. Specifically, we chose Michigan and
Vermont because legislation was recently enacted in these states
regarding groundwater extraction that included specific provisions
related to bottled water production. We chose Maine and New Hampshire
because these states recently enacted or amended laws governing
groundwater wells or withdrawals that apply to certain bottled water
production facilities. In these states, we interviewed officials who
oversee groundwater extraction for bottled water to obtain information
on groundwater use, on known impacts of groundwater extraction from
bottled water production, and on existing regulations of groundwater
extraction for bottled water production.
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 on our audit objectives.
[End of section]
Appendix I: FDA and IBWA Standards of Quality and Selected EPA Drinking
Water Standards:
In this table, units are in milligrams per liter, unless otherwise
noted.
Contaminant: Inorganic chemicals: Antimony;
FDA standard of quality: 0.006;
EPA drinking water standard (maximum contaminant level): 0.006;
IBWA standard of quality: 0.006.
Contaminant: Inorganic chemicals: Arsenic;
FDA standard of quality: 0.01;
EPA drinking water standard (maximum contaminant level): 0.01;
IBWA standard of quality: 0.01.
Contaminant: Inorganic chemicals: Asbestos;
FDA standard of quality: No standard[A];
EPA drinking water standard (maximum contaminant level): 7 million
fibers per liter;
IBWA standard of quality: No standard.
Contaminant: Inorganic chemicals: Barium;
FDA standard of quality: 2;
EPA drinking water standard (maximum contaminant level): 2;
IBWA standard of quality: 1.
Contaminant: Inorganic chemicals: Beryllium;
FDA standard of quality: 0.004;
EPA drinking water standard (maximum contaminant level): 0.004;
IBWA standard of quality: 0.004.
Contaminant: Inorganic chemicals: Cadmium;
FDA standard of quality: 0.005;
EPA drinking water standard (maximum contaminant level): 0.005;
IBWA standard of quality: 0.005.
Contaminant: Inorganic chemicals: Chromium;
FDA standard of quality: 0.1;
EPA drinking water standard (maximum contaminant level): 0.1;
IBWA standard of quality: 0.05.
Contaminant: Inorganic chemicals: Copper;
FDA standard of quality: 1[B];
EPA drinking water standard (maximum contaminant level): Treatment
technique;[C] action level[D] = in more than 90% of samples in
a monitoring period the copper concentration is greater than 1.3[E];
IBWA standard of quality: 1.
Contaminant: Inorganic chemicals: Cyanide;
FDA standard of quality: 0.2;
EPA drinking water standard (maximum contaminant level): 0.2;
IBWA standard of quality: 0.1.
Contaminant: Inorganic chemicals: Fluoride;
FDA standard of quality: Depends on temperature and other factors;
EPA drinking water standard (maximum contaminant level): 4.0[F];
IBWA standard of quality: Depends on temperature and other factors.
Contaminant: Inorganic chemicals: Lead;
FDA standard of quality: 0.005[G];
EPA drinking water standard (maximum contaminant level): Treatment
technique; action level = in more than 90% of samples in a
monitoring period the lead concentration is greater than 0.015;
IBWA standard of quality: 0.005.
Contaminant: Inorganic chemicals: Mercury;
FDA standard of quality: 0.002;
EPA drinking water standard (maximum contaminant level): 0.002;
IBWA standard of quality: 0.001.
Contaminant: Inorganic chemicals: Nickel;
FDA standard of quality: 0.1;
EPA drinking water standard (maximum contaminant level): No
standard;
IBWA standard of quality: 0.1.
Contaminant: Inorganic chemicals: Nitrate (as nitrogen);
FDA standard of quality: 10;
EPA drinking water standard (maximum contaminant level): 10;
IBWA standard of quality: 10.
Contaminant: Inorganic chemicals: Nitrite (as nitrogen);
FDA standard of quality: 1;
EPA drinking water standard (maximum contaminant level): 1;
IBWA standard of quality: 1.
Contaminant: Inorganic chemicals: Total nitrate and nitrite (as
nitrogen);
FDA standard of quality: 10;
EPA drinking water standard (maximum contaminant level): 10;
IBWA standard of quality: 10.
Contaminant: Inorganic chemicals: Selenium;
FDA standard of quality: 0.05;
EPA drinking water standard (maximum contaminant level): 0.05;
IBWA standard of quality: 0.01.
Contaminant: Inorganic chemicals: Thallium;
FDA standard of quality: 0.002;
EPA drinking water standard (maximum contaminant level): 0.002;
IBWA standard of quality: 0.002.
Contaminant: Organic chemicals: Acrylamide;
FDA standard of quality: No standard[H];
EPA drinking water standard (maximum contaminant level): Treatment
technique[I];
IBWA standard of quality: No standard.
Contaminant: Organic chemicals: Alachlor;
FDA standard of quality: 0.002;
EPA drinking water standard (maximum contaminant level): 0.002;
IBWA standard of quality: 0.002.
Contaminant: Organic chemicals: Atrazine;
FDA standard of quality: 0.003;
EPA drinking water standard (maximum contaminant level): 0.003;
IBWA standard of quality: 0.003.
Contaminant: Organic chemicals: Benzene;
FDA standard of quality: 0.005;
EPA drinking water standard (maximum contaminant level): 0.005;
IBWA standard of quality: 0.001.
Contaminant: Organic chemicals: Benzo(a)pyrene;
FDA standard of quality: 0.0002;
EPA drinking water standard (maximum contaminant level): 0.0002;
IBWA standard of quality: 0.0002.
Contaminant: Organic chemicals: Carbofuran;
FDA standard of quality: 0.04;
EPA drinking water standard (maximum contaminant level): 0.04;
IBWA standard of quality: 0.04.
Contaminant: Organic chemicals: Carbon tetrachloride;
FDA standard of quality: 0.005;
EPA drinking water standard (maximum contaminant level): 0.005;
IBWA standard of quality: 0.005.
Contaminant: Organic chemicals: Chlordane;
FDA standard of quality: 0.002;
EPA drinking water standard (maximum contaminant level): 0.002;
IBWA standard of quality: 0.002.
Contaminant: Organic chemicals: 2,4-D;
FDA standard of quality: 0.07;
EPA drinking water standard (maximum contaminant level): 0.07;
IBWA standard of quality: 0.07.
Contaminant: Organic chemicals: Dalapon; FDA standard of quality: In
this table, units are in milligrams per liter, unless otherwise noted.:
0.2; EPA drinking water standard (maximum contaminant level): In this
table, units are in milligrams per liter, unless otherwise noted.: 0.2;
IBWA standard of quality: In this table, units are in milligrams per
liter, unless otherwise noted.: 0.2.
Contaminant: Organic chemicals: 1,2-Dibromo-3-chloropropane;
FDA standard of quality: 0.0002;
EPA drinking water standard (maximum contaminant level): 0.0002;
IBWA standard of quality: 0.0002.
Contaminant: Organic chemicals: o-Dichlorobenzene;
FDA standard of quality: 0.6;
EPA drinking water standard (maximum contaminant level): 0.6;
IBWA standard of quality: 0.6.
Contaminant: Organic chemicals: p-Dichlorobenzene;
FDA standard of quality: 0.075;
EPA drinking water standard (maximum contaminant level): 0.075;
IBWA standard of quality: 0.075.
Contaminant: Organic chemicals: 1,2-Dichloroethane;
FDA standard of quality: 0.005;
EPA drinking water standard (maximum contaminant level): 0.005;
IBWA standard of quality: 0.002.
Contaminant: Organic chemicals: 1,1-Dichloroethylene;
FDA standard of quality: 0.007;
EPA drinking water standard (maximum contaminant level): 0.007;
IBWA standard of quality: 0.002.
Contaminant: Organic chemicals: cis-1,2-Dichloroethylene;
FDA standard of quality: 0.07;
EPA drinking water standard (maximum contaminant level): 0.07;
IBWA standard of quality: 0.07.
Contaminant: Organic chemicals: trans-1,2-Dichloroethylene;
FDA standard of quality: 0.1;
EPA drinking water standard (maximum contaminant level): 0.1;
IBWA standard of quality: 0.1.
Contaminant: Organic chemicals: Dichloromethane;
FDA standard of quality: 0.005;
EPA drinking water standard (maximum contaminant level): 0.005;
IBWA standard of quality: 0.003.
Contaminant: Organic chemicals: 1,2-Dichloropropane;
FDA standard of quality: 0.005;
EPA drinking water standard (maximum contaminant level): 0.005;
IBWA standard of quality: 0.005.
Contaminant: Organic chemicals: Di(2-ethylhexyl)adipate;
FDA standard of quality: 0.4;
EPA drinking water standard (maximum contaminant level): 0.4;
IBWA standard of quality: 0.4.
Contaminant: Organic chemicals: Di(2-ethylhexyl)phthalate (DEHP);
FDA standard of quality: No standard;
EPA drinking water standard (maximum contaminant level): 0.006;
IBWA standard of quality: 0.006.
Contaminant: Organic chemicals: Dinoseb;
FDA standard of quality: 0.007;
EPA drinking water standard (maximum contaminant level): 0.007;
IBWA standard of quality: 0.007.
Contaminant: Organic chemicals: Diquat;
FDA standard of quality: 0.02;
EPA drinking water standard (maximum contaminant level): 0.02;
IBWA standard of quality: 0.02.
Contaminant: Organic chemicals: Endothall;
FDA standard of quality: 0.1;
EPA drinking water standard (maximum contaminant level): 0.1;
IBWA standard of quality: 0.1.
Contaminant: Organic chemicals: Endrin;
FDA standard of quality: 0.002;
EPA drinking water standard (maximum contaminant level): 0.002;
IBWA standard of quality: 0.002.
Contaminant: Oganic chemicals: Epichlorohydrin;
FDA standard of quality: No standard[H];
EPA drinking water standard (maximum contaminant level): Treatment
technique[J];
IBWA standard of quality: No standard.
Contaminant: Organic chemicals: Ethylbenzene;
FDA standard of quality: 0.7;
EPA drinking water standard (maximum contaminant level): 0.7;
IBWA standard of quality: 0.7.
Contaminant: Organic chemicals: Ethylene dibromide;
FDA standard of quality: 0.00005;
EPA drinking water standard (maximum contaminant level): 0.00005;
IBWA standard of quality: 0.00005.
Contaminant: Organic chemicals: Glyphosate;
FDA standard of quality: 0.7;
EPA drinking water standard (maximum contaminant level): 0.7;
IBWA standard of quality: 0.7.
Contaminant: Organic chemicals: Heptachlor;
FDA standard of quality: 0.0004;
EPA drinking water standard (maximum contaminant level): 0.0004;
IBWA standard of quality: 0.0004.
Contaminant: Organic chemicals: Heptachlor epoxide;
FDA standard of quality: 0.0002;
EPA drinking water standard (maximum contaminant level): 0.0002;
IBWA standard of quality: 0.0002.
Contaminant: Organic chemicals: Hexachlorobenzene;
FDA standard of quality: 0.001;
EPA drinking water standard (maximum contaminant level): 0.001;
IBWA standard of quality: 0.001.
Contaminant: Organic chemicals: Hexachlorocyclopentadiene;
FDA standard of quality: 0.05;
EPA drinking water standard (maximum contaminant level): 0.05;
IBWA standard of quality: 0.05.
Contaminant: Organic chemicals: Lindane;
FDA standard of quality: 0.0002;
EPA drinking water standard (maximum contaminant level): 0.0002;
IBWA standard of quality: 0.0002.
Contaminant: Organic chemicals: Methoxychlor;
FDA standard of quality: 0.04;
EPA drinking water standard (maximum contaminant level): 0.04;
IBWA standard of quality: 0.04.
Contaminant: Organic chemicals: Monochlorobenzene;
FDA standard of quality: 0.1;
EPA drinking water standard (maximum contaminant level): 0.1;
IBWA standard of quality: 0.05.
Contaminant: Organic chemicals: Oxamyl;
FDA standard of quality: 0.2;
EPA drinking water standard (maximum contaminant level): 0.2;
IBWA standard of quality: 0.2.
Contaminant: Organic chemicals: Pentachlorophenol;
FDA standard of quality: 0.001;
EPA drinking water standard (maximum contaminant level): 0.001;
IBWA standard of quality: 0.001.
Contaminant: Organic chemicals: Total phenols;
FDA standard of quality: 0.001;
EPA drinking water standard (maximum contaminant level): No standard;
IBWA standard of quality: 0.001.
Contaminant: Organic chemicals: Picloram;
FDA standard of quality: 0.5;
EPA drinking water standard (maximum contaminant level): 0.5;
IBWA standard of quality: 0.5.
Contaminant: Organic chemicals: Polychlorinated biphenyls (PCBs, as
decachlorobiphenyl);
FDA standard of quality: 0.0005;
EPA drinking water standard (maximum contaminant level): 0.0005;
IBWA standard of quality: 0.0005.
Contaminant: Organic chemicals: Simazine;
FDA standard of quality: 0.004;
EPA drinking water standard (maximum contaminant level): 0.004;
IBWA standard of quality: 0.004.
Contaminant: Organic chemicals: Styrene;
FDA standard of quality: 0.1;
EPA drinking water standard (maximum contaminant level): 0.1;
IBWA standard of quality: 0.1.
Contaminant: Organic chemicals: 2,3,7,8-TCDD (Dioxin);
FDA standard of quality: 3 × 10[-8];
EPA drinking water standard (maximum contaminant level): 3 × 10[-8];
IBWA standard of quality: 3 × 10[-8].
Contaminant: Organic chemicals: Tetrachloroethylene;
FDA standard of quality: 0.005;
EPA drinking water standard (maximum contaminant level): 0.005;
IBWA standard of quality: 0.001.
Contaminant: Organic chemicals: Toluene;
FDA standard of quality: 1;
EPA drinking water standard (maximum contaminant level): 1;
IBWA standard of quality: 1.
Contaminant: Organic chemicals: Toxaphene;
FDA standard of quality: 0.003;
EPA drinking water standard (maximum contaminant level): 0.003;
IBWA standard of quality: 0.003.
Contaminant: Organic chemicals: 2,4,5-TP (Silvex);
FDA standard of quality: 0.05;
EPA drinking water standard (maximum contaminant level): 0.05;
IBWA standard of quality: 0.01.
Contaminant: Organic chemicals: 1,2,4-Trichlorobenzene;
FDA standard of quality: 0.07;
EPA drinking water standard (maximum contaminant level): 0.07;
IBWA standard of quality: 0.009.
Contaminant: Organic chemicals: 1,1,1-Trichloroethane;
FDA standard of quality: 0.2;
EPA drinking water standard (maximum contaminant level): 0.2;
IBWA standard of quality: 0.03.
Contaminant: Organic chemicals: 1,1,2-Trichloroethane;
FDA standard of quality: 0.005;
EPA drinking water standard (maximum contaminant level): 0.005;
IBWA standard of quality: 0.003.
Contaminant: Organic chemicals: Trichloroethylene;
FDA standard of quality: 0.005;
EPA drinking water standard (maximum contaminant level): 0.005;
IBWA standard of quality: 0.001.
Contaminant: Organic chemicals: Vinyl chloride;
FDA standard of quality: 0.002;
EPA drinking water standard (maximum contaminant level): 0.002;
IBWA standard of quality: 0.002.
Contaminant: Organic chemicals: Xylenes;
FDA standard of quality: 10;
EPA drinking water standard (maximum contaminant level): 10;
IBWA standard of quality: 1.
Contaminant: Inorganic chemicals: Residual disinfectants[K] and
disinfection by-products.
Contaminant: Residual disinfectants and disinfection by-products:
Bromate; FDA standard of quality: 0.01;
EPA drinking water standard (maximum contaminant level): 0.01;
IBWA standard of quality: 0.01.
Contaminant: Residual disinfectants and disinfection by-products:
Chloramine (as Cl2);
FDA standard of quality: 4;
EPA drinking water standard (maximum contaminant level): 4;
IBWA standard of quality: 4.
Contaminant: Residual disinfectants and disinfection by-products:
Chlorine (as Cl2);
FDA standard of quality: 4;
EPA drinking water standard (maximum contaminant level): 4;
IBWA standard of quality: 0.1.
Contaminant: Residual disinfectants and disinfection by-products:
Chlorine dioxide (as ClO2);
FDA standard of quality: 0.8;
EPA drinking water standard (maximum contaminant level): 0.8;
IBWA standard of quality: 0.8.
Contaminant: Residual disinfectants and disinfection by-products:
Chlorite;
FDA standard of quality: 1;
EPA drinking water standard (maximum contaminant level): 1;
IBWA standard of quality: 1.
Contaminant: Residual disinfectants and disinfection by-products:
Haloacetic acids (five) (HAA5);
FDA standard of quality: 0.06;
EPA drinking water standard (maximum contaminant level): 0.06;
IBWA standard of quality: 0.06.
Contaminant: Residual disinfectants and disinfection by-products: Total
trihalomethanes (TTHM);
FDA standard of quality: 0.08;
EPA drinking water standard (maximum contaminant level): 0.08;
IBWA standard of quality: 0.1.
Contaminant: Radiological contaminants: Gross alpha particle activity
(excluding radon and uranium);
FDA standard of quality: 15 picocuries per liter (pCi/L)[L];
EPA drinking water standard (maximum contaminant level): 15 pCi/L;
IBWA standard of quality: 15 pCi/L.
Contaminant: Radiological contaminants: Gross beta particle and photon
radioactivity;
FDA standard of quality: 4 millirems per year[M];
EPA drinking water standard (maximum contaminant level): 4 millirems
per year;
IBWA standard of quality: 50 pCi/L.
Contaminant: Radiological contaminants: Radium 226/228 (combined);
FDA standard of quality: 5 pCi/L;
EPA drinking water standard (maximum contaminant level): 5 pCi/L;
IBWA standard of quality: 5 pCi/L.
Contaminant: Radiological contaminants: Uranium;
FDA standard of quality: 30 micrograms/L;
EPA drinking water standard (maximum contaminant level): 30
micrograms/L;
IBWA standard of quality: 30 micrograms/L.
Contaminant: Microbiological contaminants: Total coliform bacteria,
including E. coli;
FDA standard of quality: Depends on the analytical method
used;[N] no positive E. coli[O];
EPA drinking water standard (maximum contaminant level): No more than
5% samples total coliform-positive in a month for systems that collect
at least 40 samples per month; no positive E. coli [P];
IBWA standard of quality: None in a 100 mL sample.
Contaminant: Microbiological contaminants: Cryptosporidium;
FDA standard of quality: No standard[Q];
EPA drinking water standard (maximum contaminant level): Treatment
technique;[R] 99% removal;
IBWA standard of quality: Treatment technique whenever unprotected
surface waters are used.
Contaminant: Microbiological contaminants: Giardia lamblia;
FDA standard of quality: No standard[S];
EPA drinking water standard (maximum contaminant level): Treatment
technique; 99.9% removal or inactivation;
IBWA standard of quality: Treatment technique whenever unprotected
surface waters are used.
Contaminant: Microbiological contaminants: Legionella;
FDA standard of quality: No standard[S];
EPA drinking water standard (maximum contaminant level): Treatment
technique;
IBWA standard of quality: Treatment technique whenever unprotected
surface waters are used.
Contaminant: Microbiological contaminants: Viruses;
FDA standard of quality: No standard[T];
EPA drinking water standard (maximum contaminant level): Treatment
technique; 99.99% removal or inactivation;
IBWA standard of quality: Treatment technique whenever unprotected
surface waters are used.
Contaminant: Microbiological contaminants: Heterotrophic plate count
(HPC);
FDA standard of quality: No standard[U];
EPA drinking water standard (maximum contaminant level): Treatment
technique; heterotrophic bacteria concentration less than or equal to
500/mL[V];
IBWA standard of quality: No standard.
Contaminant: Microbiological contaminants: Turbidity;
FDA standard of quality: 5 turbidity units;
EPA drinking water standard (maximum contaminant level): 1 turbidity
unit, except in certain circumstances based on the monthly average and
5 turbidity units based on average for 2 consecutive days;
IBWA standard of quality: 0.5 turbidity units.
Contaminant: Additional substances, including physical properties[W]:
Aldicarb[X];
FDA standard of quality: [Empty];
EPA drinking water standard (maximum contaminant level): [Empty]; IBWA
standard of quality: 0.003.
Contaminant: Additional substances, including physical properties[W]:
Aldicarb sulfone[X];
FDA standard of quality: [Empty];
EPA drinking water standard (maximum contaminant level): [Empty];
IBWA standard of quality: 0.003.
Contaminant: Additional substances, including physical properties[W]:
Aldicarb sulfoxide[X];
FDA standard of quality: [Empty];
EPA drinking water standard (maximum contaminant level): [Empty];
IBWA standard of quality: 0.004.
Contaminant: Additional substances, including physical properties[W]:
Aluminum;
FDA standard of quality: 0.2;
EPA drinking water standard (maximum contaminant level): 0.05 to 0.2;
IBWA standard of quality: 0.2.
Contaminant: Additional substances, including physical properties[W]:
Chloride;
FDA standard of quality: 250[Y];
EPA drinking water standard (maximum contaminant level): 250;
IBWA standard of quality: 250.
Contaminant: Additional substances, including physical properties[W]:
Color;
FDA standard of quality: 15 units[Y];
EPA drinking water standard (maximum contaminant level): 15 units;
IBWA standard of quality: 5 units.
Contaminant: Additional substances, including physical properties[W]:
Corrosivity;
FDA standard of quality: No standard;
EPA drinking water standard (maximum contaminant level): Noncorrosive;
IBWA standard of quality: No standard.
Contaminant: Additional substances, including physical properties[W]:
Foaming agents;
FDA standard of quality: No standard;
EPA drinking water standard (maximum contaminant level): 0.5;
IBWA standard of quality: No standard.
Contaminant: Additional substances, including physical properties[W]:
Iron;
FDA standard of quality: 0.3[Y];
EPA drinking water standard (maximum contaminant level): 0.3;
IBWA standard of quality: 0.3.
Contaminant: Additional substances, including physical properties[W]:
Manganese;
FDA standard of quality: 0.05[Y];
EPA drinking water standard (maximum contaminant level): 0.05;
IBWA standard of quality: 0.05.
Contaminant: Additional substances, including physical properties[W]:
Methyl tertiary butyl ether (MTBE);
FDA standard of quality: No standard;
EPA drinking water standard (maximum contaminant level): No standard;
IBWA standard of quality: 0.07.
Contaminant: Additional substances, including physical properties[W]:
Naphthalene;
FDA standard of quality: No standard;
EPA drinking water standard (maximum contaminant level): No standard;
IBWA standard of quality: 0.3.
Contaminant: Additional substances, including physical properties[W]:
Odor;
FDA standard of quality: 3 threshold odor number[Y];
EPA drinking water standard (maximum contaminant level): 3 threshold
odor number;
IBWA standard of quality: 3 threshold odor number.
Contaminant: Additional substances, including physical properties[W]:
pH;
FDA standard of quality: No standard;
EPA drinking water standard (maximum contaminant level): 6.5-8.5;
IBWA standard of quality: 5-7 (for purified water), 6.5-8.5 (for other
types of bottled water).
Contaminant: Additional substances, including physical properties[W]:
Silver;
FDA standard of quality: 0.1;
EPA drinking water standard (maximum contaminant level): 0.1;
IBWA standard of quality: 0.025.
Contaminant: Additional substances, including physical properties[W]:
Sulfate;
FDA standard of quality: 250[Y];
EPA drinking water standard (maximum contaminant level): 250;
IBWA standard of quality: 250.
Contaminant: Additional substances, including physical properties[W]:
1,1,2,2-Tetrachloroethane;
FDA standard of quality: No standard;
EPA drinking water standard (maximum contaminant level): No standard;
IBWA standard of quality: 0.001.
Contaminant: Additional substances, including physical properties[W]:
Total dissolved solids;
FDA standard of quality: 500[Y];
EPA drinking water standard (maximum contaminant level): 500;
IBWA standard of quality: 500.
Contaminant: Additional substances, including physical properties[W]:
Zinc;
FDA standard of quality: 5[Y];
EPA drinking water standard (maximum contaminant level): 5;
IBWA standard of quality: 5.
Source: GAO analysis of FDA's Standard of Quality Regulation, EPA's
National Primary Drinking Water Regulations, and IBWA's Code of
Practice.
[A] As stated in a December 1, 1994, Federal Register notice, FDA did
not set a standard for asbestos because the agency concluded that the
presence of any significant level of asbestos in bottled water was
highly unlikely, in part because the major source of asbestos in public
drinking water is asbestos-cement pipes used in public water systems
distributions. Because those systems must comply with EPA requirements,
FDA concluded that most, if not all, bottlers using public water
systems as a water source would be unlikely to encounter any
significant levels of asbestos in their water source.
[B] FDA has a stricter standard than EPA because leaching of copper
from distribution systems and residential plumbing is not a factor for
bottled water. FDA's standard of quality for copper is equivalent to
EPA's national secondary drinking water regulation.
[C] Treatment technique refers to a required process intended to reduce
the level of a contaminant in drinking water.
[D] Action level refers to the level of lead or copper that, if
exceeded, triggers treatment or other requirements that a water system
must follow.
[E] The national secondary drinking water regulation for copper is 1
milligram per liter.
[F] The national secondary drinking water regulation for fluoride is 2
milligrams per liter.
[G] As stated in a May 25, 1994, Federal Register notice, FDA adopted a
stricter standard than EPA because leaching of lead from distribution
systems is not a factor for bottled water. From its survey data, FDA
concluded that most bottlers are using source waters that are free from
significant lead contamination and can readily produce bottled water
products with lower lead levels.
[H] Acrylamide and epichlorohydrin occur as coagulating polymers
(flocculents) in the treatment of tap water. As stated in a December 1,
1994, Federal Register notice, FDA did not set a standard of quality
for these contaminants because EPA determined that establishing MCLs
for them was not feasible, and because FDA regulations issued under the
Food Additives Amendment of 1958 (Pub. L. No. 85-929) prohibit unsafe
use of acrylamide and epichlorohydrin (as flocculents) in the
production of bottled water.
[I] Water systems must certify that when acrylamide is used, the
combination of dose and monomer level does not exceed 0.05 percent
dosed at 1 parts per million (or equivalent).
[J] Water systems must certify that when epichlorohydrin is used, the
combination of dose and monomer level does not exceed 0.01 percent
dosed at 20 parts per million.
[K] For EPA, the highest level of a disinfectant allowed in drinking
water is known as the maximum residual disinfectant level (MRDL). The
values listed for chloramine, chlorine, and chlorine dioxide represent
the MRDL for these chemicals.
[L] Picocuries per liter is a measure of radon concentration.
[M] Exposure to radiation is generally measured in rems. Most human
exposure is so small that it can be measured in millirems (1,000
millirems = 1 rem).
[N] Using the multiple-tube fermentation method, not more than 1 of the
analytical units in the sample shall have a most probable number (MPN)
of 2.2 or more coliform organisms per 100 mL, and no analytical unit
shall have an MPN of 9.2 or more coliform organisms per 100 mL. Using
the membrane filter method, not more than 1 of the analytical units in
the sample shall have 4 or more coliform organisms per 100 mL, and the
mean of the coliform density of the sample shall not exceed 1 coliform
organism per 100 mL.
[O] On May 29, 2009, FDA issued a final rule that (1) requires that
source water be tested weekly for total coliform; (2) requires bottled
water manufacturers to test for Escherichia coli (E. coli) if testing
detects coliform organisms in the source water or finished bottled
water products; (3) prohibits source water containing E. coli from
being used for bottled water because it would not be considered to be
of a safe, sanitary quality; (4) requires bottlers to rectify or
otherwise eliminate the source of E. coli contamination in source water
and keep records of such actions before using source water from a
source that has tested positive for E. coli; and (5) treats bottled
water containing E. coli as adulterated. 74 Fed. Reg. 25651 (May 29,
2009).
[P] Any fecal coliform-positive repeat sample or E. coli-positive
repeat sample, or any total coliform-positive repeat sample following a
fecal coliform-positive or E. coli-positive routine sample constitutes
a violation of the maximum contaminant level for total coliforms. For
public notification purposes, this violation may pose an acute risk to
health.
[Q] EPA published a final rule on December 16, 1998, establishing
treatment technique requirements for improved control of
Cryptosporidium in certain public drinking water obtained from surface
water or groundwater under the direct influence of surface water. As
required by the Safe Drinking Water Act, FDA published a notice in the
Federal Register announcing that it would not issue a standard of
quality regulation because bottled water is produced either from
groundwater that is not under the influence of surface water or from
water from public water systems, which must meet EPA treatment
technique requirements. Therefore, source waters used for bottling are
not expected to contain Cryptosporidium. 66 Fed. Reg. 35439, 35440-41
(July 5, 2001).
[R] The treatment technique requirement generally consists of
installing and properly operating water treatment processes, which
reliably achieve at least 99 percent (2-log) removal of Cryptosporidium
between a point where the raw water is not subject to recontamination
by surface water runoff and a point downstream before or at the first
customer for filtered systems, or Cryptosporidium control under the
watershed control plan for unfiltered systems.
[S] On June 29, 1989, EPA published a final rule in the Federal
Register establishing treatment technique requirements for improved
control of Giardia and Legionella in public drinking water obtained
from surface water or groundwater under the direct influence of surface
water. FDA concluded that a corresponding bottled water regulation was
not necessary to protect the public health because bottled water is
produced either from water from public water systems, which is already
treated according to EPA standards, or from groundwater that is not
under the direct influence of surface water. Therefore, source waters
used for bottling are not expected to contain Giardia or Legionella.
Because EPA published this final rule before enactment of the Safe
Drinking Water Act Amendments of 1996, FDA was not required to publish
a notice in the Federal Register announcing these findings.
[T] FDA officials stated that the agency has not adopted a treatment
technique requirement for viruses for the same reason it has not
adopted a treatment technique requirement for other microbiological
contaminants (i.e., bottled water is produced from groundwater not
under the direct influence of surface water or from public water
systems, where it is already treated for such contaminants).
[U] FDA reviewed the need to regulate HPC and stated that "when bottled
waters are free of microorganisms that are of public health
significance (i.e., indicated by the absence of coliforms) and are
bottled under sanitary conditions in compliance with the current good
manufacturing practice regulations, the presence of heterotrophic
bacteria that are part of the natural flora in those bottled water
normally will not pose a health risk because these organisms do not
colonize the digestive tract of humans." 58 Fed. Reg. 52042, 52047
(Oct. 6, 1993).
[V] Monitoring for HPC is not required; public water systems may
measure HPC concentration in order to meet EPA's residual disinfectant
concentration requirement. According to EPA, there is no penalty for
having a high HPC level and HPC has no health effects.
[W] For EPA, these substances are as addressed in national secondary
drinking water regulations, or secondary standards. National secondary
drinking water regulations are nonenforceable guidelines to control
contaminants in drinking water that primarily affect the aesthetic
(such as taste, odor, or color) or cosmetic qualities (such as skin or
tooth discoloration) relating to public acceptance of drinking water.
Although not required by EPA, states with primary enforcement
responsibility may choose to adopt these secondary regulations as
enforceable regulations in the state.
[X] EPA promulgated a national primary drinking water regulation for
these contaminants on July 1, 1991, but postponed its effective date
pending reconsideration of the regulation. 57 Fed. Reg. 22178 (May 27,
1992). To date, EPA has not established a new effective date.
[Y] Mineral water is exempt from FDA's allowable level. The exemptions
are aesthetically based, allowable levels and do not relate to a health
concern.
[End of table]
[End of section]
Appendix III: Telephone Survey Administered to Officials from the 50
States and the District of Columbia, and Summary of Responses:
Below are the questions that we asked during our telephone survey with
state water quality or food protection officials from the 50 states and
the District of Columbia, and a summary of the responses that the
officials provided.[Footnote 40]
1. Does your state license, permit, or otherwise approve bottled water
facilities operating in the state?
* Yes - 48 states;
* No - 0 states.
(states without bottled water facilities excluded)
2. Does your state approve source water used for bottled water?
* Yes - 48 states;
* No - 0 states.
(states without bottled water facilities excluded)
3. Does your state require bottled water quality testing to be done by
a certified lab?
Micro biological tests:
* Yes - 31 states;
* Yes, tests can be done in-house, but they must be verified
periodically by a certified lab - 5 states;
* No - 12 states.
Other tests:
* Yes - 40 states;
* Yes, tests can be done in-house, but they must be verified
periodically by a certified lab - 1 state;
* No - 7 states.
(states without bottled water facilities excluded)
4. Does your state require bottlers to report the results of water
quality tests to the state on a scheduled basis?
* Yes - 19 states;
* Yes, but only for some contaminants - 1 state;
* No - 28 states.
(states without bottled water facilities excluded)
5. Does your state require bottlers to notify the state if water
quality tests do not meet the standard?
* Yes - 19 states;
* Yes, but only for some contaminants - 2 states;
* No - 27 states.
(states without bottled water facilities excluded)
6. Approximately how often does your state inspect bottled water
facilities?
* More frequently than once a year - 13 states;
* About once a year - 25 states;
* Once every 1-2 years - 8 states;
* Less frequently than every 2 years - 2 states.
(states without bottled water facilities excluded)
7. In the past five years, have there been any cases of excessive
contaminant levels in the state's bottled water?
* Yes - 22 states;
* No - 29 states.
8. In the past five years, has the state taken any enforcement actions,
such as issuing a warning letter or recall, against water bottlers?
* Yes - 24 states;
* No - 27 states.
9. In the past five years, has there been any conclusive evidence that
bottled water caused illnesses?
* Yes - 0 states;
* No - 51 states.
10. Has your state come across any instances of mislabeled bottled
water?
* Yes - 30 states;
* No - 21 states.
11. Has your state conducted studies, surveys, or other analyses
related to bottled water?
Yes - 15 states;
No - 36 states.
12. What, if any, misconceptions have you heard from consumers about
bottled water?
* None - 10 states;
* Identified a misconception - 41 states.
What additional information do you think could be provided to consumers
to clear up these misconceptions?
* Identified a variety of ways of providing additional information - 20
states.
13. How many bottled water facilities operate in your state?
* Provided specific numbers or ranges - 51 states.
14. What changes, if any, does the state recommend making to federal
bottled water regulations?
* Made a variety of recommendations - 23 states;
* Did not make a recommendation - 28 states.
[End of section]
Appendix IV: Comments from the Department of Health and Human Services'
Food and Drug Administration:
Department Of Health & Human Services:
Office Of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
June 5, 2009:
John B. Stephenson:
Director, Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street N.W.
Washington, DC 20548:
Dear Mr. Stephenson:
Enclosed are comments on the U.S. Government Accountability Office's
(GAO) report entitled: "Bottled Water: FDA Safety and Consumer
Protections Are Often Less Stringent Than Comparable EPA Protections
for Tap Water" (GAO-09-610).
The Department appreciates the opportunity to review this report before
its publication.
Sincerely,
Signed by:
Barbara Pisaro Clark:
Acting Assistant Secretary for Legislation:
Attachment:
[End of letter]
Department Of Health & Human Services:
Food and Drug Administration:
Silver Spring, MD 20993:
Date: June 3, 2009:
To: Acting Assistant Secretary for Legislation:
From: Principal Deputy Commissioner of Food and Drugs:
Subject: FDA's General Comments to GAO's Draft Report entitled, Bottled
Water: FDA Safety and Consumer Protection Are Often Less Stringent Than
Comparable EPA Protections for Tap Water (GAO-09-610):
FDA is providing the attached general comments to the U.S. Government
Accountability Office's draft report entitled: Bottled Water: FDA
Safety and Consumer Protection Are Often Less Stringent Than Comparable
EPA Protections for Tap Water (GAO-09-610).
FDA appreciates the opportunity to review and comment on this draft
report before it is published.
Signed by:
Joshua M. Sharfstein, M.D.
Principal Deputy Commissioner of Food and Drugs:
Attachment:
FDA's General Comments to the U.S. Government Accountability Office's
(GAO) Draft Report Entitled, "Bottled Water - FDA Safety and Consumer
Protections Are Often Less Stringent Than Comparable EPA Protections
for Tap Water" (GAO-09-610):
The Food and Drug Administration (FDA) appreciates the opportunity to
review and comment on the Government Accountability Office's (GAO)
draft report. GAO has raised some important issues regarding FDA's
bottled water program. FDA strives continually to advance its public
health mission, and this includes efforts to improve the safety,
sanitation, suitability, and proper labeling of bottled water. As an
example, on May 29, 2009, FDA published a final rule that increases
protection against fecal pathogens in bottled water by requiring more
stringent microbiological testing in source water and finished bottled
water products. Under the new rule, bottled water containing E. coli is
deemed adulterated. This final rule ensures that FDA's standards for
the minimum quality of bottled water, as affected by fecal
contamination, are no less protective of the public health than those
set by the Environmental Protection Agency (EPA) for public drinking
water.
FDA's Specific Comments on GAO Recommendations:
GAO Recommendation 1:
Issue a standard of quality regulation for DEHP or publish in the
Federal Register the agency's reasons for not doing so within 180 days
of the conclusion of its task force study on the issue.
FDA Response:
FDA agrees with GAO that, upon conclusion of the FDA task force study
on phthalates, including di(2-ethylhexyl)phthalate (DEHP), it is
appropriate to reassess whether to issue a standard of quality
regulation for DEHP in bottled water. In a July 17, 1992, final rule
(57 FR 31776), EPA established MCLs for certain contaminants, including
DEHP, in drinking water. On August 4, 1993, FDA published a proposed
rule (58 FR 41612), and on March 26, 1996, a final rule (61 FR 13258),
in the Federal Register establishing standard of quality regulations
for certain contaminants in bottled water contained in EPA's 1992 final
rule. In response to FDA's 1993 proposed rule, FDA received a comment
addressing the proposed allowable level for the chemical DEHP. The
comment pointed out that this chemical is prior sanctioned in 21 CFR
181.27 for use as a plasticizer when migrating from food-packaging
material into foods with high water content and, as such, is approved
for use in contact with food in 21 CFR 177.1210. This raised a
potential conflict between the proposed allowable level for DEHP and
the existing prior sanction for this substance found in § 181.27.
Therefore, in FDA's 1996 final rule, FDA stated that additional time
was required to evaluate this issue and deferred final action on the
proposed allowable level for DEHP.
Currently, an FDA phthalate task force is examining information
regarding the use of phthalates, including DEHP, in food contact
materials, as well as in other FDA-regulated products. Upon conclusion
of the task force study, FDA will determine if a standard of quality
regulation for DEHP in bottled water is necessary to protect the public
health. However, FDA notes that the GAO's recommended 180 day deadline
would not provide adequate time for a notice and comment rulemaking
(i.e., a proposed rule and a final rule) to establish a standard of
quality regulation and may not provide adequate time to publish in the
Federal Register the agency's reasons for not doing so. Nonetheless,
FDA agrees with GAO that it is appropriate to reassess whether to issue
a standard of quality regulation for DEHP in bottled water as soon as
possible upon conclusion of FDA task force study on phthalates.
GAO Recommendation 2:
Implement FDA's findings on methods that are feasible for conveying
information about bottled water to customers, such as, at a minimum,
requiring that companies provide on the label contact information
directing customers how to obtain comprehensive information. Should FDA
determine it lacks the necessary authority to implement its findings,
it should seek legislation to obtain such authority.
FDA Response:
FDA agrees with GAO that bottled water should be labeled with contact
information that allows consumers to contact the manufacturer to obtain
comprehensive information about the product. Although FDA already
requires that the name and place of business of the manufacturer,
packer, or distributor to be on all food products [21 CFR 101.5],
including bottled water, FDA agrees that more complete contact
information would make it easier for consumers to contact a bottled
water manufacturer and obtain such information. FDA intends to pursue
this issue with bottled water manufacturers.
FDA has the statutory authority to require information on food labels,
including bottled water, if FDA determines that the information is
material and its nondisclosure would render the labeling misleading
under sections 201(n) and 403(a) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 321(n) and 343(a)] or if such information is
required to comply with the standard of identity or standard of quality
under section 403(g) and (h) of the Act [21 U.S.C. 343(g) and (h)]. For
example, FDA requires bottlers to inform consumers when the quality of
bottled water does not meet FDA's standard of quality regulations, by
putting a statement of substandard quality on the label [21 CFR
165.100(c)]. Also, FDA requires that, when bottled water comes from a
community water system, it be labeled as such (with the exception of
purified or sterilized water because consumers buy this water because
of its treatments rather than because of its source) [21 CFR
165.110(a)(ii)]. FDA also notes that bottled water containing a
substance at a level considered injurious to health is adulterated and
therefore cannot be sold to consumers [21 CFR 165.100(d)].
[End of section]
Appendix IV: GAO Contact and Staff Acknowledgments:
GAO Contact:
John Stephenson, (202) 512-3841 or stephensonj@gao.gov:
Staff Acknowledgments:
In addition to the contact named above, Steve Elstein, Assistant
Director; Brian M. Friedman; Nathan A. Morris; Kelly A. Richburg; and
Jeanette Soares made key contributions to this report. Also
contributing to this report were Mark Braza, Ellen Chu, Erin Lansburgh,
and Minette Richardson. In addition, Matthew Drerup, Paige Gilbreath,
Susannah Hawthorne, Stephen J. Jue, Foster Kerrison, Patricia Lentini,
Robert Marek, Angela Pun, Carrie W. Rogers, Pam Tumler, and Cheryl A.
Williams provided assistance in collecting bottled water labels for our
review.
[End of section]
Footnotes:
[1] Bottled water labels collected and reviewed were for different
brands of bottled water sold in the United States.
[2] Under the Safe Drinking Water Act, states can seek primary
enforcement responsibility for public water systems if they adopt
drinking water regulations that are no less stringent than the national
primary drinking water regulations and meet other statutory and
regulatory requirements. States with primacy are responsible for
inspecting their public water systems, with EPA regional offices
providing oversight.
[3] These regulations apply to public water systems, which provide the
public with water for human consumption through pipes or other
constructed conveyances and have at least 15 service connections or
regularly serve at least 25 individuals.
[4] Prior to August 6, 1996, FDA was required to promulgate a standard
of quality regulation within 180 days of EPA promulgating a national
primary drinking water regulation, or publish in the Federal Register
its reasons for not promulgating a standard of quality regulation.
[5] This ’hammer provision“ was enacted on August 6, 1996. Prior to its
enactment, if FDA failed to promulgate a standard of quality regulation
by the statutory deadline, the national primary drinking water
regulation was not considered as the standard of quality for bottled
water.
[6] IBWA‘s membership does not include two of the largest bottled water
manufacturers in the United States”The Coca-Cola Company (Dasani) and
PepsiCo, Inc. (Aquafina).
[7] FDA has issued a Guidance for Industry entitled Food Producers,
Processors, and Transporters: Food Security Preventive Measures
Guidance that identifies preventive measures operators of food
establishments, including bottled water manufacturers, may take to
minimize the risk that food under their control will be subject to
tampering or other malicious, criminal, or terrorist actions.
[8] Di(2-ethylhexyl)phthalate, commonly referred to as DEHP, is an
organic compound widely used as a plasticizer in manufacturing
polyvinyl chloride (or PVC) plastics.
[9] Prior to August 6, 1996, FDA was required to promulgate a standard
of quality regulation within 180 days of EPA promulgating a national
primary drinking water regulation, or to publish in the Federal
Register its reasons for not promulgating a standard of quality
regulation. If FDA failed to promulgate a standard of quality, the
national primary drinking water regulation was not automatically
considered to be the standard of quality for bottled water, as it is
now.
[10] As shown in appendix II, IBWA has set a standard for DEHP that is
the same as the maximum contaminant level set by EPA.
[11] Pub. L. No. 110-85 (2007), codified at 21 U.S.C. § 350f.
[12] FDA relies on state and local government agencies to approve water
sources. Source water must be of a safe and sanitary quality, according
to the applicable laws and regulations of state and local government
agencies having jurisdiction over the water. FDA does not review these
laws and regulations, however, and the states or localities must
consult with EPA if they need assistance.
[13] In the eighth district office we contacted, contracts have
recently been established with 2 of the 3 states under the district‘s
jurisdiction. However, to date, no bottled water facilities have been
assigned for inspection.
[14] Five other states allow bottled water facilities to perform
microbiological tests in-house, but are required to have tests verified
periodically by a certified laboratory.
[15] These states are not mutually exclusive, some states require
bottlers to do both practices.
[16] This import alert was established in March 2007 in response to FDA
testing of three samples of bottled water that were imported from three
different manufacturers in Armenia and were found to contain high
levels of arsenic.
[17] According to FDA, an entry line is each portion of an import
shipment that is listed as a separate item on an entry document. Items
in an import entry having different tariff descriptions must be listed
separately.
[18] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-07-310] (Washington, D.C.: January
2007).
[19] GAO, Food Labeling: FDA Needs to Better Leverage Resources,
Improve Oversight, and Effectively Use Available Data to Help Consumers
Select Healthy Foods, [hyperlink,
http://www.gao.gov/products/GAO-08-597] (Washington, D.C.: Sept. 9,
2008).
[20] GAO, Overseeing the U.S. Food Supply: Steps Should Be Taken to
Reduce Overlapping Inspections and Related Activities, [hyperlink,
http://www.gao.gov/products/GAO-05-549T] (Washington, D.C.: May 17,
2005).
[21] Department of Health and Human Services, FDA, Food Protection
Plan: An Integrated Strategy for Protecting the Nation‘s Food Supply
(Washington, D.C.: November 2007).
[22] [hyperlink, http://www.gao.gov/products/GAO-07-310].
[23] GAO, Food Safety and Security: Fundamental Changes Needed to
Ensure Safe Food, [hyperlink, http://www.gao.gov/products/GAO-02-47T]
(Washington, D.C.: Oct. 10, 2001).
[24] 21 C.F.R. Part 101.
[25] [hyperlink, http://www.gao.gov/products/GAO-08-597].
[26] 65 Fed. Reg. 51,833 (Aug. 25, 2000).
[27] FDA was not required to determine whether such information
requirements are necessary. Furthermore, FDA was not required to review
whether it was feasible and appropriate to inform consumers right away,
as is required of public water systems, if contaminant levels exceed
standards.
[28] Polyethylene terephthalate (PET, or PETE) is a plastic resin that
is commonly used to package beverages and other food products,
cosmetics, and household cleaners. PET is the type of plastic labeled
with the #1 code on or near the bottom of a container.
[29] P. H. Gleick and H. S. Cooley, Pacific Institute, ’Energy
Implications of Bottled Water,“ Environmental Research Letters, vol. 4,
no. 014009 (2009).
[30] A megajoule is equal to 1 million joules; a joule is a unit of
work or energy.
[31] The energy required for the manufacture, transport, and use of
bottled water also results in carbon dioxide emissions. We did not
review any comprehensive peer-reviewed studies of carbon dioxide
emissions associated with the manufacture, transport, and use of
bottled water in the United States. The Pacific Institute, Container
Recycling Institute, and IBWA provided us with information about the
greenhouse gas emissions associated with various aspects of bottled
water production and use. We did not independently verify the accuracy
or completeness of the data they provided.
[32] T.C. Winter, et al, U.S. Geological Survey, Ground Water and
Surface Water: A Single Resource, U.S. Geological Survey Circular 1139
(Denver: 1998). W.M. Alley, et al., U.S. Geological Survey,
Sustainability of Ground-Water Resources, U.S. Geological Survey
Circular 1186 (Denver: 1999).
[33] A geologist from the New Hampshire Department of Environmental
Services told us that data for bottled water extraction approved prior
to August 1998 are not available to reliably assess the local impacts
that may have occurred.
[34] See Mich. Citizens for Water Conservation v. Nestle Waters N. Am.
Inc., 709 N.W. 2d 174 (Mich. App. 2005) (the court ruled that while the
bottling company could have ’fair participation“ in the common water
resources of the area, the company‘s pumping of approximately 24
percent of the base flow of a stream exceeded fair participation),
affirmed in part and reversed in part on other grounds 737 N.W. 2d 447
(Mich. 2007).
[35] These 10 states are California, Georgia, Kentucky, Louisiana,
Maine, Maryland, Massachusetts, Missouri, Wisconsin, and Vermont. Ohio
is the state that has the same requirements as FDA.
[36] After speaking with officials in some of these states, we learned
that their state bottled water requirements mirror FDA requirements.
For example, 1 state recently enacted new legislation that mirrors FDA
requirements but was not yet reflected in the state code.
[37] GAO field offices are located in Atlanta, Georgia; Boston,
Massachusetts; Chicago, Illinois; Dallas, Texas; Dayton, Ohio; Denver,
Colorado; Huntsville, Alabama; Los Angeles, California; Norfolk,
Virginia; San Francisco, California; and Seattle, Washington.
[38]Polyethylene terephthalate (PET, or PETE) is a plastic resin that
is commonly used to package beverages and other food products,
cosmetics, and household cleaners. PET is the type of plastic labeled
with the #1 code on or near the bottom of a container.
[39] P.H. Gleick and H. S. Cooley, Pacific Institute, ’Energy
Implications of Bottled Water,“ Environmental Research Letters, vol. 4,
no. 014009 (2009).
[40] Wisconsin provided its responses in writing.
[End of section]
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