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| This article was published in FDA Consumer magazine several years ago. It is no longer being maintained and may contain information that is out of date. You may find more current information on this topic in more recent issues of FDA Consumer or elsewhere on the FDA Website, by checking the site index or home page, or by searching the site. |
Bottled Water: New Trends, New Rules
by Victor Lambert
It's practically everywhere. In the workplace. Beside
exercise stations in health clubs. At athletic events. In
backpacks hanging from the shoulders of students. Even on
tables at conferences and workshops. Bottled water, once
considered the refreshment of the affluent, has become the
liquid icon of today's active, health-conscious consumer.
In 1984, Americans consumed an average of 4 gallons of
bottled water per person. By 1991, that number had doubled,
according to data collected by the International Bottled Water
Association (IBWA).
More than 700 different brands of bottled water are
available in the United States. Seventy-five of those brands
are made from imported waters. The average retail price of a
1-gallon bottle of domestic drinking water is 90 cents, $5.29
for a 5-gallon bottle that is delivered.
Taste is the number one reason why people say they prefer
bottled water, according to consumer attitude and usage
surveys conducted by IBWA, the trade association for the $2
billion bottled water industry.
The final disinfectant agent used by most of the nation's
430 bottling facilities is ozone, a form of oxygen. But,
unlike the chlorine used to disinfect tap water, ozone leaves
no chemical residual aftertaste or smell.
The second reason more people today are choosing bottled
water has to do with the notion that it's purer and healthier.
Because low levels of lead or chlorination byproducts are
sometimes found in tap water, most bottled water drinkers
believe the bottled variety is healthier than water from the
tap. But is it?
Making Bottled Water Safe
Bottled water quality standards were originally adopted
in 1973 and were based on the 1962 U.S. Public Health Service
standards for drinking water.
In 1974, the Safe Drinking Water Act made the
Environmental Protection Agency responsible for ensuring the
safety of municipal water systems, which includes setting
maximum limits for chemical, bacteriological and radioactive
contaminants and physical contaminants that affect odor, taste
and color. In 1986, amendments to the Safe Drinking Water Act
required EPA to set additional standards. When EPA adds or
amends a contaminant standard, the Food and Drug
Administration must set an acceptable level for it in bottled
water or publish in the Federal Register its reasons for not
doing so.
Since 1975, under the "misbranded products" provision of
the Federal Food, Drug, and Cosmetic Act, FDA has been
responsible for ensuring that the quality standards for
bottled water are compatible with EPA standards for quality
and safety of tap water. In 1978, FDA broadened the bottled
water standards to include maximum allowable contaminant
levels for pesticides, mercury and radioactive matter.
In carrying out its mission to ensure the safety of
bottled water, FDA also inspects bottled water facilities on
a regular basis. Like other foods, bottled water must be
processed, packaged, shipped, and stored in a safe and
sanitary manner, and be truthfully and accurately labeled.
According to Terry Troxell, Ph.D., director of FDA's
division of programs and enforcement policy in the Office of
Plant and Dairy Foods and Beverages, "If we [FDA] find a
problem during an inspection, we make that company a priority
and FDA field personnel inspect it more frequently. For
example, after the Perrier 'mineral' water incident in 1990
[when the carcinogen benzene was found in Perrier], we did a
follow-up survey to analyze the water's quality."
State agencies, some under contract to FDA, and industry
also conduct regular inspections of bottled water facilities
in an effort to ensure that only safe products are
distributed.
"We're interested in making sure bottled water companies
produce safe products and that they're truthfully labeled,"
Troxell said.
The terms "spring," "well," "artesian," "distilled,"
"purified" and "mineral" have appeared on bottled water labels
for years. But recently, there have been an increasing number
of companies whose labels didn't match their products.
At the same time, variations in how states define the
different types of bottled water have been an issue. In North
Carolina, for example, "spring" water refers only to water
that has been collected from the natural orifice in the
earth's surface. In other states, it can be both water that
has been collected from the natural orifice or from a bore
hole that taps the spring and is located near where the spring
emerges.
As a result, FDA, last Jan. 5, announced proposed
regulations that would establish standard definitions for all
bottled water products, and set new limits for approximately
50 chemical and other contaminants that may be present in
bottled water. FDA has already established quality standards
for 31 contaminants.
The regulations would also apply the quality standard
requirements for bottled water to mineral water.
IBWA petitioned FDA to establish stricter guidelines for
bottled water in l988.
After studying the situation, FDA proposed standard
definitions because the terms provided by the "misbranded
products" provision of the Food, Drug, and Cosmetic Act were
not specific enough for use in identifying components of such
a diverse group of bottled water products.
"The bottled water industry has grown too much over the
last few years to continue handling violations on a case-by-
case basis," Troxell said. "We need revised bottled water
regulations that are broad based."
Revising the Regulations
Under the proposed regulations, "artesian" water would be
considered bottled water that is drawn from a well that taps
a confined aquifer (a water-bearing rock, rock formation, or
group of rocks) in which the water level stands above the
natural water table.
"Distilled" water would be bottled water that has been
produced by a process of distillation--vaporizing water, then
condensing it in a way that leaves it free of dissolved
minerals.
"Purified" water would be water that is produced by
distillation, deionization (passing water through resins that
remove most of the dissolved minerals), reverse osmosis (the
use of membrane filters to remove dissolved solids), or other
suitable processes, and that meets the U.S. Pharmacopeia's
most recent definition of "purified" water. The U.S.
Pharmacopeia establishes the standard for "purified" water
because it is commonly used in laboratories and for medical
purposes.
"Spring" water would be bottled water obtained from an
underground formation from which water flows naturally to the
surface, or would if it were not collected underground through
a bore hole where a spring emerges.
Bottled water that comes from a hole bored, drilled, or
otherwise constructed in the ground to tap an aquifer would be
called "well" water.
"Mineral" water, which was previously exempt from bottled
water quality standards, would be water that comes from a
source tapped at one or more bore holes or springs originating
from a geologically and physically protected underground water
source. "'Mineral' water was exempt until now because it was
only consumed in very small amounts," Troxell said. "It was
considered a different product."
In addition to including "mineral" water in the proposed
regulations, the water ingredient in certain types of flavored
bottled waters have to comply with the same maximum allowable
contaminant levels required of other bottled waters.
The proposed regulations, however, would continue to
exclude products labeled as "carbonated" water, "seltzer"
water, "soda" water, and "tonic" water, because they are
considered soft drinks.
"We think the proposed regulations are well done and
we're completely supportive," said Ronald Davis, president of
IBWA and chairman of the Greenwich, Conn.-based Perrier Group
of America. "They provide the basis to have bottled water
regulated in an intelligent yet thorough way."
And what about bottled water that actually comes from
municipal water systems? All products fitting this
description, under the proposed regulations, would have to be
clearly labeled as such. The requirement would be dropped,
however, if the water has been taken from municipal water
supplies and then processed and treated in a way that would
enable it to be labeled "distilled" or "purified."
Approximately 75 percent of bottled water comes from
protected springs and wells. The other 25 percent is derived
from municipal water systems that meet federal and state
requirements established by the 1974 Safe Drinking Water Act.
Under the stricter restrictions in the proposed
regulations, the bottled water label would have to state if
the water comes from a municipal source.
The proposed regulations also require specific labeling
on bottled waters marketed for infants. Labels on this type of
water would have to indicate if the water is not sterile and
that it should only be used as directed by a physician or
according to infant formula preparation instructions.
Besides addressing labeling issues, the proposed
regulations would set maximum limits for many contaminants
found in bottled water.
Reducing Contaminants
Under a final rule published in the Jan. 3, 1993, Federal
Register, the allowable levels for seven synthetic volatile
organic chemicals were amended to comply with maximum
contaminant levels set by EPA. The seven chemicals are:
benzene, carbon tetrachloride, 1,2-dichloroethane, 1,1-
dichloroethylene, 1,1,1-trichloroethane, trichloroethylene,
and vinyl chloride.
Proposed regulations would also revise or affirm maximum
levels for inorganic substances such as lead, copper, mercury,
barium, and cadmium.
The proposed regulations would also establish or modify
permitted levels for 28 synthetic organic chemicals, including
10 synthetic volatile organic chemicals, 17 pesticides, and
polychlorinated biphenyls.
In all, the proposed regulations would establish 27 new
chemical levels and amend the existing allowable levels of
many others.
"The new regulations mean a lot to us for two reasons,"
IBWA's Davis said. "They'll help ensure that bottled water is
as good as tap water, and they'll make labeling consistent
from state to state. But we're pleased with the new
regulations and look forward to implementing them."
Victor Lambert, now with Howard University, Washington, D.C.,
wrote this article while on the staff of FDA Consumer. Judith
Levine Willis also contributed to this article.
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