Bottled
Water Regulations
Questions &
Answers
I.
Regulations
- How is
bottled water
regulated?
Bottled
water is a highly
regulated product,
subject to federal,
state and industry
standards. The U.S.
Food and Drug
Administration
(FDA), under the
Federal Food, Drug
and Cosmetic Act
(FFDCA or the Act),
regulates bottled
water as a food
product. This
includes packaged
water sold in
smaller containers
at retail outlets as
well as larger
five-gallon
containers
distributed to the
home and office
market. Like all
food products except
meat and poultry
(which are regulated
by USDA), bottled
water is subject to
FDA’s extensive food
safety and labeling
requirements, which
include:
- Food
adulteration and
misbranding
provisions;
- Nutritional
labeling
provisions;
- General
Good Manufacturing
Practices (GMPs);
- Bottled
water GMPs;
- Bottled
water standard of
identity; and
- Bottled
water standard of
quality, which is
as stringent as
the U.S.
Environmental
Protection
Agency’s (EPA)
standards for
public water
supplies.
The bottled
water industry is
further regulated on
two additional
levels: state
standards and trade
association
standards for
International
Bottled Water
Association (IBWA)
members. In
addition, all
bottled water
products imported
from countries
outside of the U.S.
must meet the
standards
established by their
own country as well
as comply with all
of the U.S.
regulations.
- What
regulations do states
impose on the bottled
water industry?
In addition
to FDA’s extensive
regulatory
requirements, the
bottled water
industry is subject
to state regulatory
requirements as
well. Although some
state regulations
are more
comprehensive than
others are, most
state regulations
either reference
federal standards or
are analogous to
them.
Inspections:
A
significant
responsibility of
the state is
inspecting,
sampling,
analyzing and
approving sources
of water. All of
the states have
the authority to
inspect and review
a bottlers’
operations and
record keeping. To
get a source
approved, a
bottler needs to
have it inspected,
and the water
needs to be
sampled and
analyzed to ensure
that it is safe to
drink. This is a
federal
requirement under
the FDA’s GMPs,
which is
implemented by an
appropriate state
agency. Under the
federal GMPs, only
approved sources
of water can be
used to supply a
bottling plant.
Laboratory
Certification:
Another area in
which some states
have important
responsibilities
that complement
federal
regulations is the
certification of
testing
laboratories. As
with any food
laboratory, the
states can perform
unannounced
inspections of
bottled water
testing
laboratories, and
some states
perform these
annually.
- When was the
bottled water industry
first regulated?
Since
1938, the FDA has
regulated bottled
water as a packaged
food under the
Federal Food, Drug
and Cosmetic Act
(FFDCA). As a food
product, bottled
water must be
packaged in sealed,
sanitary containers.
The U.S.
Environmental
Protection Agency
(EPA) has regulated
the quality of
public water
supplies (tap water)
delivered to
consumers by their
local utilities
since 1974. By law,
FDA regulations for
bottled water must
be no less stringent
than the EPA’s
regulations for tap
water.
It is the
Good Manufacturing
Practices (GMPs)
that ensure the
safety of all
bottled water
products from
production to
packaging to
consumption. GMPs
were mandated by law
under the 1962
Kefauver-Harris Drug
Amendments. Some
GMPs, which are
specific to bottled
water processing and
bottling, address
plant construction
and design; sanitary
facilities; sanitary
operations;
equipment design and
construction;
production and
process controls;
and record keeping.
Bottled water is one
of only five food
products that have
GMPs above what is
required of all
foods.
In
compliance with the
FDA’s standard of
quality regulation
established in 1974,
bottled water
manufacturers are
also required to
ensure that their
products adhere to
the allowable levels
for substances in
bottled water, such
as those for
coliform and lead.
This regulation
includes levels
related to
microbiological
quality, such as the
limit on the number
of coliform
organisms; physical
quality, such as
turbidity, color and
odor; chemical
quality, such as the
limits on organic
and inorganic
chemicals; and
radiological
quality, such as the
limit on radium 226.
Bottled
water manufacturers
also must ensure
that their products
meet the FDA
established standard
of identity for
bottled water
products, which was
established in 1996.
A bottled water
product bearing a
particular statement
of identity, for
example "mineral
water," must meet
the particular
requirements of the
standard of identity
for mineral water to
avoid being
misbranded. There
are definitions for
bottled water,
drinking water,
artesian water,
ground water,
distilled water,
deionized water,
mineral water,
reverse osmosis
water, purified
water, sparkling
bottled water,
spring water,
sterile water and
well water. If a
bottled water is
misbranded, it is
subject to recall.
- Do bottled
water and tap water
differ in terms of
safety and quality
regulations?
The FDA
regulates bottled
water as a food
product and the EPA
regulates the
quality of public
water supplies (tap
water) as a utility.
To ensure that
bottled water is
regulated in a
manner similar to
tap water, the FDA
must review all new
regulations for tap
water to determine
if they are
applicable to
bottled water. If
the regulations are
applicable, FDA must
propose comparable
regulations for
bottled water within
a specified period
of time.
- How is
bottled water
different from tap
water?
Consistent
quality and taste
are two of the
principal
differences between
bottled water and
tap water.
While
bottled water
originates from
protected sources
(75 percent from
underground aquifers
and springs), tap
water comes mostly
from rivers and
lakes. Another
factor to consider
is the distance tap
water must travel
and what it goes
through before it
reaches the tap. In
compliance with FDA
regulations, bottled
water is sealed and
packaged in sanitary
containers. In
the unlikely chance
a bottled water
product is found to
be substandard, it
can be recalled. Tap
water cannot.
- If bottled
water is from a
municipal source, does
the source have to be
indicated on the
label?
According to
FDA regulations, when
the source for bottled
water comes from a
community water system
the product label must
state that the bottled
water is "from a
community water
system" or "from a
municipal source."
However, if
the water is subject
to distillation,
deionization or
reverse osmosis, the
bottled water product
can be legally defined
as purified water,
demineralized water,
deionized water,
distilled water or
reverse osmosis
drinking water and
does not have to state
on its label that it
is "from a community
water system" or "from
a municipal source."
Processing methods
such as reverse
osmosis remove most
chemical and
microbiological
contaminants.
Only 25
percent of bottled
water comes from
municipal sources. The
remaining 75 percent
of bottled water sold
in the U.S. comes from
natural underground
sources, which include
springs and wells.
II.
FDA Compliance Tests
for Bottlers
- How
frequently is the
water tested?
In
compliance with FDA
regulations, bottlers
must submit water
samples, to either
in-house or outside
testing labs, to be
analyzed for physical,
chemical and
radiological
parameters on an annual
basis. For many of the
analyses, such as
those for inorganic
chemicals, an annual
schedule is more
frequent than what the
EPA requires for tap
water. Bottlers test
their water annually
for some pesticides
and other synthetic
organic compounds
(SOCs) and volatile
organic compounds
(VOCs). Bottlers may
apply for and receive
waivers based upon
past test results,
reducing the frequency
of testing.
Bottlers
must also test for
the presence of
bacteria at least weekly
for each of their
water products for
all of the available
packaging sizes.
Many bottlers have
in-house quality
control laboratories
that conduct a
number of on-site
tests that include
an examination of daily
bacteriological
analysis, basic
physical or chemical
parameters, total
dissolved solids,
pH, turbidity, color
and conductivity
that may impact the
taste of the water.
In addition, every
bottler must keep
the results of their
current testing
data, which the FDA
could ask for at any
time.
- What is the
water tested for?
On an annual
basis, bottlers must
also analyze finished
product samples for
the following:
- Inorganic
contaminants
(including pH,
nitrate,
chloride,
fluoride,
total
dissolved
solids)
- Trace
metals
- Minerals
(including
nickel,
mercury and
silver)
- Volatile
organic
compounds
(VOCs)
- Pesticides
and PCBs
- Herbicides
- Synthetic
organic
compounds
(SOCs)
- Gross
alpha and
beta/radium
(radiological
analysis)
Many
bottlers sell
bottled water in
states that
require additional
testing parameters
or more frequent
testing. In
addition to the
tests listed above
and frequencies
cited, bottlers
conduct additional
internal quality
control testing
that includes the
testing of
containers and
closures, which
are required quarterly.
The testing
required for
microbiological
evaluation,
fillers and the
quality of the air
in the bottling
facility are
conducted on an ongoing
basis.
III. IBWA’s
Model Code
- What does it
mean when a company
says it is a member of
IBWA?
The bottled
water produced by IBWA
members must meet
standards that are, in
some cases, stricter
than the FDA’s
standards. IBWA has
developed a quality
assurance program
called the Model Code,
which is a strict set
of standards for the
safe processing of
bottled water. All
members of IBWA must
meet the standards
contained in the Model
Code. In fact, the
Model Code has been
used as model
regulation in many
states.
Additionally,
as a condition of
membership, bottlers
are subject to an
annual, unannounced
inspection
administered by an
independent
internationally
recognized
third-party
organization. This
inspection assures
that all IBWA
bottler members meet
federal, state and
IBWA requirements
for the production
and sale of bottled
water.
- How does the
Model Code go beyond
the FDA regulations
for the bottled water
industry?
Some of the
standards contained in
the Model Code
actually exceed the
FDA regulations
currently in place for
the bottled water
industry. For
example, the Model
Code has a 100 parts
per billion (ppb)
maximum contaminant
level (MCL) for
chlorine whereas the
FDA does not have a
standard of quality
for chlorine.
IV. IBWA’s
Unannounced
Inspections
- Who does the
unannounced
inspections?
NSF
International
(formerly known as the
National Sanitation
Foundation), an
independent auditing
and compliance firm,
recognized by the
World Health
Organization as a
Collaborating Center
for Food Safety as
well as for Drinking
Water Safety and
treatment, conducts
the annual unannounced
inspections of IBWA
member bottling
facilities. This
inspection assures
that all IBWA bottler
members meet federal,
state and IBWA
requirements for the
production and sale of
bottled water.
- How does NSF
International ensure
compliance with the
Model Code?
The purpose
of NSF International's
unannounced
inspections is to
ensure that IBWA
bottler members’
quality standards are
in compliance with the
requirements of the
Model Code. For
example, IBWA bottler
members must analyze
their source and their
final bottled water
product. On a weekly
basis, bulk water
shippers must collect
samples from each
tanker for
bacteriological
analysis. IBWA
presently mandates a
schedule of analysis
to be implemented by
its members. IBWA
bottler members submit
the full records of
their bottled water
test results to the
NSF International
inspector.
- What happens
if a bottler fails the
inspection?
Although
rare, if a bottler
does fail the
inspection, the
bottler must take
corrective action to
rectify the problem.
IBWA fully documents
and verifies the
corrective measures
that were taken. Any
deficiencies
discovered during
their unannounced
annual inspection must
be corrected within 30
days. In addition, a
second inspection is
performed at the
bottler’s expense.
- If a bottler
fails the inspection,
does it mean that they
failed to meet Federal
Regulations?
Just
because a bottler
failed IBWA’s
unannounced
inspections does not
necessarily mean that
they failed to meet
Federal Regulations.
In some instances,
IBWA’s Model Code
standards are more
stringent than the FDA
regulations currently
in place for bottled
water.
Glossary
- What does
"source approval"
mean?
To get a
source approved, a
bottler needs to have
the source inspected,
and the water needs to
be sampled and
analyzed to ensure
that it is safe to
drink.
- What does
"source protection"
mean?
Source
protection involves
maintaining the water
source in such a way
that it is not exposed
to, or influenced by,
contamination. By
selecting appropriate
sources, it is
possible to ensure
that the water taken
from the source is not
susceptible to
environmental
contaminants, or any
agricultural or
industrial pollutants.
Combined with source
monitoring, source
protection is an
effective way of
ensuring bottled
water’s safety and
purity.
- What does
"source monitoring"
mean?
Source
monitoring involves a
series of tests and
procedures designed to
determine whether a
source is suitable for
use. For example, on a
weekly basis tests are
conducted to evaluate
the microbiological
characteristics of a
source. However,
sources are tested on
an annual basis for
chemical, physical and
radiological
characteristics. Once
a source is selected,
it is monitored,
ensuring bottled water
manufacturers that the
source of their water
continues to be safe
and of high quality.
In addition, natural
underground sources
must be inspected,
tested and certified
by the state or
country of origin to
be of sanitary
quality.
###
The
International Bottled
Water Association (IBWA)
is the authoritative
source of information
about all types of
bottled waters. Founded
in 1958, IBWA's
membership includes U.S.
and international
bottlers, distributors
and suppliers. IBWA is
committed to working
with the U.S. Food and
Drug Administration
(FDA), which regulates
bottled water as a
packaged food product,
and state governments --
strengthened by IBWA
Model Code -- to set
stringent standards for
safe, high quality
bottled water products.
Consumers can contact
IBWA at 1-800-WATER-11
or log onto IBWA's web
site
(www.bottledwater.org)
for more information
about bottled water and
a list of members'
brands. Media inquiries
can be directed to Gwen
Haynes at 703-683-5213
ext 107.
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