# Beverages: Bottled Water

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URL: https://www.frixlaw.com/law-library/documents/fr%3A95-27798

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** November 13, 1995
- **Citation:** 60 FR 57076

## Text

SUMMARY: The Food and Drug Administration (FDA) is establishing a
standard of identity for bottled water. At the same time, the agency is
recodifying the standard of quality for bottled water. FDA is revising
the definition for bottled water in the quality standard to include
mineral water and ingredient uses of this product. In addition, FDA is
defining ``artesian water,'' ``ground water,'' ``mineral water,''
``purified water,'' ``sparkling bottled water,'' ``spring water,''
``sterile water,'' and ``well water.'' FDA is exempting mineral water
from certain physical and chemical allowable levels. FDA is taking
these actions, in part, in response to a petition submitted by the
International Bottled Water Association (IBWA). FDA finds that the
regulations will promote honesty and fair dealing in the interest of
consumers as well as the interests of the regulated industry.

EFFECTIVE DATE: May 13, 1996. The Director of the Office of the Federal
Register approves the incorporations by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51 of certain publications at 21 CFR
129.35(a)(3)(ii), 129.80(g), and 184.1563(c), effective May 13, 1996.

FOR FURTHER INFORMATION CONTACT: Shellee A. Davis, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4681.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 5, 1993 (58 FR 393), FDA
published a proposal to establish a standard of identity in
Sec. 165.110(a) for bottled water (hereinafter referred to as the
January 1993 proposal). At the same time, the agency proposed to
recodify in Sec. 165.110 (b), (c), and (d), the standard of quality for
bottled water currently found in Sec. 103.35. FDA proposed to revise
the definition for bottled water in the quality standard to include
mineral water and ingredient uses of this product. In addition, FDA
proposed to define ``artesian water,'' ``distilled water,'' ``mineral
water,'' ``purified water,'' ``spring water,'' and ``well water.'' FDA
proposed to exempt mineral water from certain physical and chemical
allowable levels if the mineral water contained total dissolved solids
(TDS) in excess of 500 parts per million (ppm). Interested persons were
given until March 8, 1993, to submit comments.
In the Federal Register of March 9, 1993 (58 FR 13041), FDA
extended the comment period to April 7, 1993. In addition, the agency
reopened the comment period for comments concerning two spring water
surveys that FDA received in response to the proposal (58 FR 34010,
June 23, 1993). Interested persons were given until July 23, 1993, to
submit comments concerning the two spring water surveys.
FDA received approximately 430 responses, each of which contained
one or more comments, from trade and retail associations, government
organizations, manufacturers, consumers, health care professionals,
retailers, consumer groups, State groups, private organizations, the
U.S. Congress, professional societies, and universities. The comments
generally supported the proposal. Several comments addressed issues
outside the scope of the proposal (e.g., microbiological quality
standards, definitions for multicomponent bottled water beverages) that
will not be discussed here. A number of comments suggested
modifications and revisions in various provisions of the proposal. A
summary of the suggested changes and the agency's responses follow.
Elsewhere in this issue of the Federal Register, FDA is proposing
to update the methods referenced in Sec. 165.110(b)(3) and to exempt
mineral water from the allowable level for aluminum in the quality
standard. FDA is responding to the comments on the January 1993
proposal that addressed those issues in that proposal.

II. The Standard of Identity

A. Coverage

The agency proposed in the January 1993 proposal, to move the
definition for bottled water from the quality standard to the standard
of identity and to revise the definition to include mineral water and
ingredient uses of bottled water. Specifically, FDA proposed that
bottled water be defined as water that is intended for human
consumption and that is sealed in bottles or other containers with no
added ingredients, except that it may contain safe and suitable
antimicrobial agents. The agency also proposed that bottled water may
be used as an ingredient in beverages (e.g., diluted juices, flavored
bottled water) but stated that the term did not cover those food
ingredients that are declared in ingredient labeling as ``water,''
``carbonated water,'' ``disinfected water,'' ``filtered water,''
``seltzer water,'' ``soda water,'' and ``tonic water.'' Finally, FDA
proposed that the processing and bottling of bottled water must comply
with applicable regulations in part 129 (21 CFR part 129).
1. One comment asked why bottled water is singled out for a source
identification requirement (e.g., water from a municipal source), and
why soft drinks, beers, reconstituted juices, salad dressings, and
other products that contain water as an ingredient are not also subject
to this requirement.
The agency considered the scope of the bottled water standard,
particularly its application to water used as an ingredient in
multicomponent foods such as flavored waters and diluted juices, in the
proposal to this final rule (58 FR 393 at 395). FDA stated that
highlighting the water component of these products is effectively a
claim that the water ingredient in the beverage has particular value,
and that consumers are likely to purchase these products in large
measure because of the claim concerning the water ingredient. For
example, in a significant number of situations, the labeling of
products stated or implied that the water originated from a source such
as a spring or a well. In contrast, in products such as soft drinks or
reconstituted juices in which water is simply used as an ingredient, no
claim is made about the water. The intent of the proposal was not to
require source labeling of all water ingredients from a municipal
source, but to require it in the former type of situation, where the
finished product is bottled water or the labeling makes an explicit or
implied claim concerning the water ingredient.
Under section 403(a) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 343(a)), a product is misbranded if its labeling
is false or misleading in any particular. To determine whether the
absence of information on food labels constitutes misbranding the
agency must take into account the extent to which the labeling fails to
reveal facts material in light of representations made or suggested
with respect to consequences that may result from the use of the
article under customary or usual conditions of use (section 201(n) of
the act (21 U.S.C. 321(n))). The agency does not deem

[[Page 57077]]
source labeling of ingredient water from a municipal source as a
material fact unless labeling representations are made or suggested
that the water possesses particular properties.
Thus, the agency finds no reason to include water that is not a
highlighted ingredient in the bottled water standards, and the comment
has not provided a basis to do so. Therefore, Sec. 165.110 applies only
to bottled water and ingredient uses of water where the water
ingredient is highlighted in the labeling.
2. Two comments expressed concern about sparkling water being
regulated under the bottled water standards. They stated that sparkling
water has long been understood by consumers and recognized by FDA as a
common or usual name for unsweetened and unflavored water containing
compressed carbon dioxide. The comments contended that consumers
clearly understand ``sparkling water'' to be in the same category as
``carbonated water,'' ``seltzer water,'' ``soda water,'' and ``tonic
water,'' substances that historically have been regulated by FDA as
``soft drinks.'' They stated that as such, ``sparkling water'' is more
appropriately classified as a ``soft drink'' that is not subject to the
proposed bottled water standard.
Some comments stated that it was unclear whether ``sparkling
water'' was included under the exemption for ``carbonated water'' and
asked for clarification. One comment stated that if the standard does
not encompass the term, FDA should include ``sparkling water'' in the
definition of bottled water.
FDA stated in the preamble to the proposed rule that when a
beverage is labeled as containing ``water,'' ``carbonated water,''
``disinfected water,'' ``filtered water,'' ``seltzer water,'' ``soda
water,'' and ``tonic water,'' there is no claim that the water
ingredient has particular value, and that, thus, these ingredients were
not included in the definition of bottled water (58 FR 393 at 395).
This proposed exclusion did not extend to the term ``sparkling water''
or to any other term not specifically excluded by the standard. In the
proposal, the agency used the example of the term ``sparkling'' as
indicating that the water ingredient possessed a specific
characteristic or had received a specific treatment (id.). FDA
tentatively concluded at that time that use of such highlighted terms
concerning the water component was effectively a claim that the water
ingredient in the beverage had particular value, and that consumers
were likely to purchase these beverages in large measure because of the
claim.
The agency notes, however, that sparkling water was included in the
former soda water standard. In the Federal Register of February 16,
1967 (32 FR 2940), the agency amended the soda water standard to add
the term ``sparkling water'' to the standard as an example of a type of
soda water generally designated by a particular common name. FDA
proposed this change to permit the designation of nonsweetened and
nonflavored soda water by names other than those prescribed in the
standard (31 FR 11109, August 20, 1966). However, FDA repealed the
standard of identity for soda water in the Federal Register of January
6, 1989 (54 FR 398) because some provisions of the standard were being
adequately dealt with by other regulations, while other provisions were
no longer necessary.
Given the traditional use of this term, as evidenced by the
repealed standard, the agency agrees that the term ``sparkling water''
describes a nonsweetened and nonflavored carbonated water, and that it
thus, is a term that is synonymous with the term ``carbonated water.''
The fact is that the agency had separate standards at one time for
bottled water and for soda water, and that it included sparkling water
in the soda water, and not the bottled water standard. Therefore, the
comments have persuaded the agency that some types of sparkling water
are in the same category as ``carbonated water,'' ``seltzer water,''
``soda water,'' and ``tonic water,'' and should be regulated as a soft
drink instead of as a bottled water. Accordingly, the bottled water
standard in Sec. 165.110 does not include those food ingredients that
are declared in ingredient labeling as ``water,'' ``carbonated water,''
``disinfected water,'' ``filtered water,'' ``seltzer water,'' ``soda
water,'' ``sparkling water'' (except as explained in this response) and
``tonic water.''
However, the term ``sparkling water'' may also refer to water that
is naturally carbonated (i.e., contains carbon dioxide as it emerges
from the source) and that is labeled as ``sparkling water.'' The
bottled water standard has traditionally included this type of water
because the water has not been carbonated in the same sense that a soda
water is carbonated (i.e., with added carbon dioxide). Thus, water that
contains carbon dioxide as extracted from the source is not a soda
water and must continue to be regulated as a bottled water. Therefore,
to differentiate between the two types of sparkling waters, the agency
is defining ``sparkling bottled water'' in Sec. 165.110(a)(2)(v) as
bottled water that, after treatment and possible replacement of carbon
dioxide, contains the same amount of carbon dioxide that it had at
emergence from the source. This definition is in accordance with the
definition in the European Regional Codex Standard (ERCS) for
``naturally carbonated natural mineral water'' (Ref. 1).
The agency concludes that defining the term ``sparkling bottled
water'' is within the scope of this rulemaking because FDA proposed
that sparkling water be included under the bottled water standard. As a
consequence of proposing that course of action, FDA has been persuaded
that some types of sparkling water should be excluded from the standard
and that it should differentiate among the types of sparkling water in
its bottled water regulations.
3. Two comments objected to the exclusion of carbonated bottled
waters from the bottled water standards. They stated that any product
that professes to be, or that has as an important ingredient that is
one of the defined bottled water types (e.g., spring water, mineral
water), whether noncarbonated or carbonated, should be considered to be
bottled water. The comments contended that only those carbonated
products with respect to which no reference is made to defined bottled
water types should be excluded.
The agency agrees with the comment. Products or ingredients
described by a term that is defined by the standard of identity (e.g.,
``spring water'') or with a term that makes a claim about the water
(e.g., ``natural water'') are standardized waters and must comply with
Sec. 165.110 whether carbonation has been added or not. Although terms
to describe the water ingredient in a product may sometimes be used in
combination with a term that is not included under the standards (e.g.,
``carbonated spring water'' or ``filtered natural water''), the product
or the water ingredient in the product must comply with the bottled
water standards because a claim is being made concerning the value of
the water. However, use of only a term specifically excluded from the
bottled water standards (e.g., ``filtered water'' or ``carbonated
water'') means that no claim is being made concerning the value of the
water, and, thus, the water is not a standardized food.
4. Several comments stated that it is inconsistent for FDA to
exempt carbonated waters from the bottled water standards. They held
that carbonated water may be consumed at levels which constitute a
major portion of an individual's daily water intake. One comment added
that exempting

[[Page 57078]]
carbonated water from the bottled water category does not provide for
consumer safety or confidence.
The agency does not agree with the comments, although it
acknowledges that carbonated waters may constitute a major portion of
some consumers' daily water intake. However, FDA points out that
standards of identity and quality are not established because a product
is consumed in large volumes or for consumer safety or confidence but
are established to promote honesty and fair dealing in the interest of
consumers.
``Carbonated water'' or ``soda water'' has traditionally not been
covered by the provisions of the bottled water quality standard because
it has been considered to be a soft drink. Bottled water and soda
water, although similar, are two different foods as evidenced by the
fact that the agency had quality standards for bottled water at the
same time that it had a standard of identity for soda water that
included ``carbonated water.''
FDA tentatively concluded in the proposal that it would not include
``carbonated water'' in the standards for bottled water because it has
historically not been considered to be bottled water. In addition, the
agency tentatively concluded that the standards for bottled water
covered water ingredients that were highlighted because of a claim
concerning the water ingredient itself.
Labels of foods that claim to contain as an ingredient, or to be,
``carbonated water'' do not claim or imply any particular properties or
characteristics for the water ingredient. Any claims on such foods for
the ingredient are simply that carbon dioxide has been added. Thus,
``carbonated water'' does not fit within the type of food that the
bottled water standard is intended to address because no claim is being
made about the water itself. The agency finds no reason to include
``carbonated water'' in the bottled water standard, and the comment has
not provided any basis to do so. Therefore, the agency concludes that
it has not been inconsistent in the regulation of ``carbonated water''
and ``bottled water.''
5. Two comments stated that the terms ``carbonated water,''
``disinfected water,'' ``filtered water,'' ``seltzer water,'' ``soda
water,'' and ``tonic water'' should be defined to avoid confusion by
industry and consumers as to what types of water are covered by the
bottled water standards and what types of water are not. One of the
comments stated that these terms may have different meanings to the
bottled water and beverage industries and consumers.
The agency does not agree with the comments. There is general
understanding of the meanings of these terms, even though they are not
defined in FDA's regulations. ``Carbonated water,'' ``disinfected
water,'' ``filtered water,'' ``seltzer water,'' ``soda water,'' and
``tonic water'' are common or usual names that are in general use by
both manufacturers and consumers. In the proposal to this final rule
(58 FR 393 at 395), the agency noted that the terms ``carbonated
water,'' ``seltzer water,'' ``soda water,'' and ``tonic water'' have
historically been considered to be soft drinks, and that ``disinfected
water'' and ``filtered water'' described water that has been subjected
to a commonly used treatment.
The reason for not addressing these terms under the bottled water
standard is that they make no claims about the water used in the
ingredients that they denominate. The exclusion is not based on the
specific source, composition, or processing of these types of waters.
The comments did not provide any information to persuade the agency to
conclude otherwise. Therefore, FDA is not defining these common terms
at this time. However, persons interested in establishing definitions
for ``carbonated water,'' ``disinfected water,'' ``filtered water,''
``seltzer water,'' ``soda water,'' and ``tonic water'' may petition the
agency to do so, providing recommended definitions and justification
for the recommendations.
6. Several comments objected to any definition of bottled water
that does not allow for the addition of ingredients such as minerals
for flavor, flavors that comprise less than 1 percent by weight of the
product, and carbon dioxide. They stated that changing the definition
of bottled water to exclude established products would: (1) Be costly
to the bottled water industry; (2) exempt excluded bottled water
products from meeting FDA's proposed health, safety, and quality
standards; and (3) confuse rather than unify regulatory authority. One
comment declared that it is imperative that the final regulation
include all established products of the bottled water industry.
One comment stated that some model codes and State regulations
provide for the addition of ingredients to bottled water provided that
these additives comprise less than 1 percent by weight of the final
product. The comment noted that many consumers may supply a major
portion of their daily water intake needs with these 1 percent bottled
water products.
Another comment noted that Sec. 129.80(a) states that carbonation,
mineral addition, or any other process shall be done in a manner so as
to be effective in accomplishing its intended purpose and in accordance
with section 409 of the act. It stated that there is no reason to
disallow any of these processes or their resultant products as bottled
water.
FDA does not agree that it is changing the definition of bottled
water. The agency acknowledges that some State regulations define
bottled waters with added flavors, minerals, and carbon dioxide as
described in the comments (Ref. 2). However, the Federal definition of
``bottled water'' has traditionally been ``water that is sealed in
bottles or other containers and that is intended for human
consumption'' (Secs. 103.35(a)(1) and 129.3(b) (1994)). This definition
is the basis of the definition that FDA is adopting in this final rule
(Sec. 165.110(a)(1)). Although Sec. 129.80(a) mentions treatment of
product water with carbonation and mineral addition, among other
processes, any bottled water product with added ingredients would be
just that--bottled water with added ingredients. (However, see the
discussion of fluoride in bottled water in comment 8 of this document.)
Firms may manufacture nonstandardized bottled water products with
ingredients such as minerals for flavor, flavors that comprise less
than 1 percent by weight of the product, and carbon dioxide added to
bottled water. The common or usual name of the resultant product must
reflect these additions. However, only the bottled water ingredient is
subject to the standard in Sec. 165.110. The other ingredients in the
product are subject to regulation under the food additive or other food
ingredient provisions of the act. Thus, it is not necessary to include
added ingredients, such as minerals for flavor, flavors that comprise
less than 1 percent by weight of the product, or carbon dioxide, in the
standard for bottled water.
Therefore, for the reasons listed above the agency is not persuaded
by the comments to include the addition of minerals, flavors, and
carbon dioxide in the standard of identity for bottled water in
Sec. 165.110(a)(1).
7. One comment stated that all bottled waters imported into the
United States should meet all of FDA's requirements for bottled waters
including mineral water. It added that U.S. standards should not be
lessened to meet European standards unless there are compelling public
health reasons for doing so.
FDA agrees that both foreign and domestic bottled waters sold in
interstate commerce in the United States must comply with the act and
the regulations issued thereunder, including the specific regulations
for bottled water

[[Page 57079]]
found in part 129 and Sec. 165.110. Although the agency attempts, where
possible, to harmonize its regulations with the regulations of other
countries, there must be appropriate grounds for FDA to amend any of
its bottled water regulations, whether or not such action would
harmonize international standards.

B. Fluoridated Water

The agency did not propose a definition for ``fluoridated water,''
although it did request comments on the need to define types of bottled
water other than those for which it proposed definitions. Some comments
addressed issues on fluoridated water that fall within the scope of
this rulemaking. Therefore, the agency is addressing these issues in
this final rule.
8. Several comments stated that the addition of fluoride to bottled
water should be allowed. One comment noted that many people
specifically request and use fluoridated water because of its benefits
to dental health. The comment stated that these products have long been
established and should not be discontinued. One comment noted an
inconsistency between the definition of bottled water and the
provisions of proposed Sec. 165.110(b)(4)(ii) that discuss the addition
of fluoride.
FDA agrees that there is an inconsistency between the proposed
standard of identity and the standard of quality for bottled water with
respect to the addition of fluoride. The agency proposed in
Sec. 165.110(a)(1) that bottled water contain no added ingredients
other than safe and suitable antimicrobial agents. This provision would
preclude the addition of fluoride (58 FR 393 at 407). The quality
standard, however, provides maximum levels for bottled water to which
fluoride is added (Sec. 165.110(b)(4)(ii)).
The agency recognizes that water with fluoride added may provide a
benefit to consumers. The Surgeon General's Report on Nutrition and
Health (the Surgeon General's report) recommends that community water
systems contain fluoride at optimal levels for prevention of tooth
decay, and that, if such water is not available, other appropriate
sources of fluoride should be used (Ref. 3). Bottled water may be used
by some consumers as an alternative to community drinking water.
Therefore, because of the unique circumstances presented by fluoride,
the agency is providing for the optional addition of fluoride to
bottled water in Sec. 165.110(a)(1) within the limitations established
in the quality standard (Sec. 165.110(b)(4)(ii)).
Because the agency is providing for the optional addition of
fluoride to bottled water, the standardized product may be a
multiingredient food, and, as such, its label must bear ingredient
labeling. According to Sec. 101.4(a)(1) (21 CFR 101.4(a)(1)), all food
ingredients are required to be declared on the label. Therefore,
bottled water containing added fluoride must list the names of the
water ingredient and the fluoride.
Therefore, because FDA is providing for the optional addition of
fluoride to bottled water, and thus, bottled water may be a
multicomponent food, the agency is adding Sec. 165.110(a)(4) to require
that each of the ingredients used in the food be declared on the label
as required by the applicable sections of 21 CFR parts 101 and 130.
9. Several comments requested that FDA define ``fluoridated
water.'' Some of these comments recommended that ``fluoridated water''
be defined as bottled water containing naturally occurring or added
fluoride, and that the label specify whether fluoride is naturally
occurring or added. One comment stated that the regulation only
discusses maximum limits on fluoride addition without setting a
minimum, thus opening a loophole that would allow manufacturers to add
insignificant amounts of fluoride to their products and call them
``fluoridated water.'' One comment stated that any water that is called
``fluoridated water'' should contain not less than 0.8 milligram per
liter (mg/L) fluoride ion. Another comment stated that any water that
is defined as ``fluoridated water'' should contain not less than 1.0
mg/L fluoride. One comment requested that ``fluoridated water'' be
defined only as water containing added fluoride.
FDA has provided for the use of the terms ``fluoridated,''
``fluoride added,'' and ``with added fluoride'' on the label or in
labeling of bottled water that contains added fluoride in
Sec. 101.13(q)(8). The agency adopted this regulation in the Federal
Register of January 6, 1993 (58 FR 2302 at 2314) and stated that the
presence of fluoride in bottled water is of interest to consumers, and
its declaration should not be prohibited. However, the agency also
stated that it did not wish to encourage unnecessary addition of
fluoride to bottled water, and that it was concerned that if it
permitted the use of terms like ``good source of fluoride'' or ``high
in fluoride,'' they might encourage such additions. Therefore, the
agency has not defined a nutrient content claim for fluoride. Instead,
it has provided that a statement indicating the presence of added
fluoride could be used, but that the claim cannot include a description
of the level of fluoride present.
As stated in another final rule in the Federal Register of January
6, 1993 (58 FR 2079 at 2149), the agency has considered the identity
statement ``fluoridated water'' to be misleading if the product is
derived from a source naturally containing fluoride. Because the term
``fluoridated'' represents that fluoride has been added to the water,
FDA concluded that the term ``fluoridated water'' should be used to
describe only products to which fluoride has been added in the
manufacturing process, and that such products would be required to bear
nutrition labeling that complies with the simplified format (id.). FDA
also points out that fluoride may not be present in amounts that exceed
the limits in Sec. 165.110(b)(4)(ii).
Although labeling could be used to describe whether fluoride was
added or naturally present in bottled water, the term ``fluoridated''
continues to mean that fluoride has been added. FDA is not establishing
a minimum level for fluoride addition because the terms
``fluoridated,'' ``fluoride added,'' or ``with added fluoride'' have
been defined in Sec. 101.13(q)(8) and amending that provision falls
outside the scope of this final rule. However, if the addition of
fluoride to water is so minimal that it would be considered dietarily
insignificant, a product that bears a claim about such addition would
be misbranded under section 403(a) of the act in that its labeling
would be misleading because the use of the term ``fluoridated'' or any
of its synonyms implies that fluoride has been added in a meaningful
amount. Thus, FDA concludes that it has not created a loophole that
would allow manufacturers to add insignificant amounts of fluoride to
their products and call them ``fluoridated water.''
The Surgeon General's Report states that the optimal fluoride
concentration of approximately 1 ppm fluoride has been shown to reduce
the prevalence of dental caries by more than 50 percent (Ref. 3). In
addition, the Surgeon General's Report states that current
recommendations for optimum fluoride concentrations vary from 0.7 to
1.2 ppm (id.). Therefore, the comments' suggested values of 0.8 mg/L
and 1.0 mg/L fluoride are meaningful amounts of this mineral in bottled
water.
10. One comment stated that infant bottled waters may contain
fluoride, and that the presence of this mineral may be a problem if
parents are not aware that too much fluoride is undesirable, or that an
infant should not receive both a physician's prescription of fluoride

[[Page 57080]]
drops and drink water containing fluoride. For this reason, the comment
stated that the label of a bottled water containing 0.3 ppm or more
fluoride should include a statement advising parents not to use the
product before consulting with their baby's physician if the baby is
receiving a fluoride supplement. The comment added that bottled water
for general use is also used for infants, so such a label statement
should be required on any bottled water containing 0.3 ppm or more
fluoride. It stated that this level of fluoride is taken from the
current recommendation of pediatricians and pediatric dentists relating
to administration of fluoride supplements. It suggested that the
statement could read as follows: ``Note: If you are giving your baby a
fluoride supplement, do not use water with fluoride without consulting
your doctor.''
The agency agrees that an advisory statement such as that suggested
by the comment may be appropriate to prevent unwanted aesthetic effects
from excessive doses of fluoride, and it encourages manufacturers to
provide such information to consumers, especially on products labeled
for infant use. However, FDA does not agree that this statement should
be mandatory on all bottled waters containing 0.3 ppm or more fluoride.
There are allowable levels for fluoride in the quality standard, and
bottled water exceeding these levels must be labeled as substandard.
The allowable levels are related to secondary levels established by the
Environmental Protection Agency (EPA) for public drinking water in 40
CFR parts 141 and 143 and take into consideration excessive infant
fluoride intake. In addition, as discussed in the previous comment, the
Surgeon General's Report recommends an optimal level of 1.0 ppm
fluoride in drinking water.
Fluoride supplements are generally prescribed for breast-fed
infants because those infants frequently consume little or no water.
Human milk contains little fluoride, even in areas with fluoridated
water supplies. Physicians may also prescribe fluoride supplements for
infants not receiving adequate dietary fluoride. Health care
professionals must take into consideration the patient's weight and the
exposure to fluoride from dietary and other sources to establish the
proper dose (Ref. 4).
Therefore, the agency finds no basis to require an advisory
statement concerning infant fluoride consumption on bottled waters
containing 0.3 ppm or more fluoride.

C. Nomenclature

FDA proposed that the name of the standardized food meeting the
definition of bottled water in Sec. 165.110(a)(1) is ``bottled water''
or one of the following defined terms: ``Artesian water,'' ``distilled
water,'' ``mineral water,'' ``purified water,'' ``spring water,'' and
``well water.'' The agency requested comments from interested persons
on the definitions for these terms and on other terms that need to be
defined.
11. A number of comments requested that FDA define the term
``drinking water'' because: (1) It is the most commonly used term to
describe bottled water and represents 36 to 40 percent of the gallonage
of bottled water sold in food stores; (2) the lack of a Federal
definition allows States to adopt special, nonuniform definitions for
this segment of the bottled water market; and (3) many bottlers would
have to revise their drinking water labels to remove this term to come
into compliance with the standard, and doing so would impose severe
economic hardships to the industry. One comment noted that producers of
5-gallon returnable bottled water products have a very large investment
in bottle inventories that are designed to last for a considerable
time, and that a high percentage of these packages is permanently
labeled as ``drinking water.'' It stated that it would be costly to
dispose of these containers, and that the use of stick-on labels would
present problems in its manufacturing operation.
Some comments recommended modifying paragraph Sec. 165.110(a)(2) to
define the terms ``bottled water'' and ``drinking water'' synonymously.
However, other comments stated that ``drinking water'' is a
classification within the bottled water category along with ``spring
water,'' ``mineral water,'' and ``purified water.'' These comments
suggested the following definition: ``Drinking water means bottled
water obtained from an approved source that has at a minimum undergone
treatment consisting of filtration (activated carbon or particulate)
and ozonation or an equivalent disinfection process. Drinking water
that has been treated to meet the definitions of distilled or purified
water may contain added minerals for taste, provided an ingredient
statement `minerals added for taste' or optionally `minerals added for
flavor' appears on the label.''
One comment stated that it is important for FDA to define drinking
water as only one type of bottled water, and that the terms ``drinking
water'' and ``bottled water'' not be interchangeable. It stated that
``bottled water'' includes and describes all types of bottled water
products, including bottled ``drinking water,'' but that bottled
``drinking water'' does not include or describe all types of ``bottled
water.'' It stated that it is important that FDA define ``drinking
water'' to prevent the consumer confusion that would result if this
product type, already marketed to and accepted by the public, is not
recognized by FDA as a specific type of bottled water. It stated that
failure to do so could, at worst, mean that products labeled as
``drinking water'' could no longer be sold in interstate or foreign
commerce involving the United States.
Conversely, two comments stated that the term ``drinking water''
should not be permitted on the label because consumers may be misled
because they do not understand the meaning of the term.
The agency agrees with the comments that stated that it should
define the term ``drinking water.'' Consumers are familiar with the
term because, as the comments pointed out, products labeled as
``drinking water'' comprise a significant portion of the bottled water
market. In addition, not defining this term would impose an economic
hardship on the bottled water industry because products labeled as
``drinking water'' would have to be relabeled as ``bottled water.''
However, FDA disagrees with the comments that said that ``drinking
water'' should be defined differently than ``bottled water.'' As
required by the standard of quality, ``bottled water'' must meet
certain quality requirements, or the water is substandard and must be
labeled as such. The definition for ``drinking water'' suggested by the
comments provides an apt description of the method of processing
bottled water that is used by many manufacturers. Thus, FDA concludes
that a separate definition of ``drinking water'' is not warranted.
In addition, EPA has standards for ``drinking water'' from public
water systems (40 CFR parts 141 and 143) that are nearly identical to
FDA's standards for bottled water. FDA is not aware of any reason why
its standard for ``drinking water'' that is sold in a bottle should
differ significantly from EPA's standard for ``drinking water.''
Therefore, the agency is including ``drinking water'' as an alternative
name for ``bottled water'' in Sec. 165.110(a)(2).
The agency agrees with the comments that pointed out that if
minerals are added to bottled water or drinking water, an appropriate
statement of identity must appear on the principal display panel of the
label of the product

[[Page 57081]]
to inform consumers of this fact (e.g., ``drinking water with minerals
added for taste''). An ingredient statement must also appear on the
label in accordance with Sec. 101.4(a). In addition, if sodium,
calcium, or iron are present in the bottled water product in more than
an insignificant amount, nutrition labeling is required.
12. One comment suggested that an alternative name for ``spring
water'' or ``well water'' could be ``ground water.''
The agency agrees that ``ground water'' is an appropriate name for
water from a spring or a well. The term ``ground water'' encompasses
not only ``spring water'' and ``well water'' but also ``artesian
water'' and ``mineral water'' because by definition all of these waters
come from an underground source. A geological definition states that
``ground water'' is water in the saturated zone that is under a
pressure equal to or greater than atmospheric pressure (Ref. 5). The
saturated zone is the subsurface zone in which all openings are full of
water (id.).
Because ``ground water'' is an appropriate alternative term to
describe some types of bottled water, and because in the January 1993
proposal, the agency requested comments from interested persons on
other terms that need to be defined, the agency concludes that it is
within the scope of this rulemaking to define the term ``ground
water.'' FDA concludes that the geological definition stated above is
appropriate. Therefore, the agency is defining ``ground water'' in
Sec. 165.110(a)(2)(ii) to mean water from a subsurface saturated zone
that is under a pressure equal to or greater than atmospheric pressure.
(Because the agency is establishing an additional definition in
Sec. 165.110(a)(2), it is recodifying the other terms in
Sec. 165.110(a)(2) so that they continue to appear in alphabetical
order.) The agency is also requiring in Sec. 165.110(a)(2)(ii) that
``ground water'' not be under the direct influence of surface water.
EPA defines ground water under the direct influence of surface water as
any water beneath the surface of the ground with: (1) Significant
occurrence of insects or other macroorganisms, algae, or large-diameter
pathogens such as Giardia lamblia; or (2) significant and relatively
rapid shifts in water characteristics such as turbidity, temperature,
conductivity, or pH which closely correlate to climatological or
surface water conditions (40 CFR 141.2). Ground water under the direct
influence of surface water is not ``ground water'' because water that
does not meet this definition is mingling with water that otherwise
would meet the definition. To clarify that ground water must not be
under the direct influence of surface water, FDA concludes that this
distinction should be included in the definition of ``ground water.''
13. One comment stated that FDA should establish a separate
definition for ``sterilized water.'' It stated that water for the
initial feeding of babies has been called ``sterilized water'' for
decades. The comment held that all water intended for the initial
feeding of infants should be commercially sterile, as defined in the
low-acid canned food processing regulations (21 CFR part 113). The
comment stated that to require a change in the statement of identity
from ``sterilized water'' to ``bottled water'' or ``purified'' or
``distilled water'' would create confusion in hospitals and could
result in nonsterilized ``bottled water'' or ``purified'' or
``distilled water'' being fed to newborns. The comment suggested that
the following definition be added to Sec. 165.110(a)(2)(vi): ``The name
of the water intended as the initial feeding of infants may be
`sterilized water' provided it meets the definition of commercial
sterility contained in 21 CFR 113.3(e)(1)(i).''
The agency agrees that the terms ``sterile water'' and ``sterilized
water'' should be defined as a specific bottled water type. Doing so is
the logical outgrowth of FDA's request in the proposal for other terms
that need to be defined. Defining these terms will mean that the water
must meet a certain minimum standard to be labeled with these terms and
will allow firms to prominently label their products in the statements
of identity as having been treated to achieve this standard.
The definition of commercial sterility in Sec. 113.3(e)(1)(i)
states that ``commercial sterility'' of thermally processed food means
the condition achieved by the application of heat that renders the food
free of microorganisms capable of reproducing in the food under normal
nonrefrigerated conditions of storage and distribution and of viable
microorganisms (including spores) of public health significance.
FDA notes that the United States Pharmacopeia (USP) has official
monographs for ``sterile water for inhalation,'' ``sterile water for
injection,'' and ``sterile water for irrigation.'' The monographs
require that each of these types of water meet sterility requirements
set forth by the USP (Ref. 6). These requirements involve
microbiological tests to determine the presence of viable
microorganisms. If no evidence of microbial growth is observed, the
article tested meets the requirements of the test for sterility.
The difference between the sterility standard in
Sec. 113.3(e)(1)(i) and that used by USP is that water that is
commercially sterile may contain bacteria, although in an innocuous
amount, whereas water that is sterile according to USP standards does
not. The agency acknowledges that water for general drinking purposes
need not be sterile or even commercially sterile. However, sterile
water may be purchased by immunosuppressed individuals, contact lens
wearers, infant caretakers, and laboratories with an expectation that
the water is free of any bacteria. In addition, FDA finds that it would
be confusing to consumers to have two standards for sterility, one for
``sterile water'' and another for ``sterile water, USP.''
Therefore, the agency concludes that bottled water labeled as
``sterile'' must meet the USP definition. Thus, FDA is defining the
terms ``sterile water'' and ``sterilized water'' in
Sec. 165.110(a)(2)(vii) to mean water that meets the requirements under
``Sterility Tests'' in the USP, 23d Revision.
14. Several comments requested that the agency clarify whether a
bottler may use any name defined in Sec. 165.110(a)(2) as long as the
bottled water complies with the definition used. One comment asked
whether mineral water that contains between 250 and 500 ppm TDS could
be labeled as ``mineral water,'' ``mineral spring water,'' or ``mineral
well water.''
The agency advises that if more than one term is applicable,
bottlers may combine the terms, as appropriate, in naming the food
(e.g., ``mineral spring water, low mineral content''). Thus, bottlers
will be able to label their products in an informative manner because
all applicable terms can be presented prominently on the labels in the
statements of identity. Because this approach will ensure the
informativeness of the statement of identity, FDA finds that it will
promote honesty and fair dealing in the interest of consumers.
Therefore, FDA is revising Sec. 165.110(a)(2) to state that the name of
the food is ``bottled water,'' ``drinking water,'' or alternatively one
or more of the terms listed in that section as appropriate.
15. Two comments expressed concern that the proposed definitions
for ``artesian water,'' ``mineral water,'' ``spring water,'' and ``well
water'' provide an opportunity for unintended mineral content
manipulation that could lead to potential consumer deception. To
alleviate this problem, the comments requested that FDA revise the

[[Page 57082]]
definitions for each of these waters to include the following:
``Artesian water (or mineral water, spring water, or well water) shall
not be altered by addition or deletion of minerals or by blending it
with water from a nonartesian water source.''
FDA disagrees that the suggested revision is warranted or needed.
Once a defined bottled water product (e.g., artesian water, mineral
water, spring water, or well water) has been blended with water from
another source, the product no longer meets the definition of that
particular type of bottled water, although it remains bottled water.
For example, if artesian water is blended with spring water to reduce
the water hardness, the product is ``bottled water'' or ``drinking
water,'' although its labeling may state the percentages of the
artesian water and spring water it contains. Mineral water may be
labeled as ``mineral water'' even if it is a blend of one or more
waters, as long as each of the component waters complies with the
source, composition, and other requirements of Sec. 165.110(a)(2)(iii).
The agency notes that mineral addition or deletion does not change
the source of the water. However, if the water has been altered
significantly from the source water, under section 201(n) of the act,
that the alteration has been made is a fact material in the light of
representations made and must appear on the label of the product. The
water is no longer unmodified ground water and differs significantly
from the water that was harvested. Therefore, the fact that the water
has been altered significantly must be included in the statement of
identity so that consumers are aware that the source water has been
modified. If minerals have been added, the statement of identity must
state that fact. If minerals have been removed from the product, other
than those that are removed during normal processing (e.g., filtration
to remove precipitates), that fact must be included in the statement of
identity of the product (e.g., partially demineralized)
(Sec. 165.110(a)(2)(iii)). Therefore, FDA concludes that the requested
revision is not necessary.
1. Artesian Water
The agency proposed to define ``artesian water'' as water from a
well tapping a confined aquifer in which the water level stands above
the natural water table. The agency also proposed to provide for the
collection of artesian water with the assistance of an external force
to enhance the natural underground pressure so long as such measures do
not alter the physical properties, composition, and quality of the
water.
16. One comment stated that FDA should not permit the use of the
term ``artesian'' on bottled water labels because it is the most
misused term in the bottled water business today.
The agency disagrees that it should prohibit the use of the name
``artesian.'' Because FDA is defining this term in the standard of
identity for bottled water, manufacturers will have to label their
products in accordance with the standard or face regulatory action. FDA
expects that misuse of the term will cease as a result. Therefore, FDA
concludes that this comment, rather than establishing why FDA should
not define ``artesian water,'' only serves to point up why defining
this term will promote honesty and fair dealing in the interest of
consumers, and, thus, why it is appropriate for FDA to do so.
17. Several comments stated that the original and vernacular
meaning of ``artesian water'' is water that is forced from below the
ground to the surface through a well by natural underground pressure
and collected at or above the surface. They recommended that this
definition be adopted.
One comment pointed out that the geologic definition that FDA
referenced in the proposal actually states that ``the water level in
artesian wells stands at some height above the top of the aquifer but
not necessarily above the land surface'' and does not require that the
water stand above the water table. Therefore, the comment added, the
water level in an artesian well may be either above or below the water
table and still be considered artesian. The comment stated that the
distinction in the geologic definition between the water table and the
top of the confined aquifer is an important technical one, and that the
proposed definition is much more restrictive and not the one that is
generally accepted by groundwater scientists.
The agency disagrees with the comments that contended that the
water in an artesian well must flow to the surface. As mentioned by the
latter comment described above, the geologic definition states that
``the water in artesian wells stands at some height above the top of
the aquifer but not necessarily above the land surface'' (Ref. 5).
Therefore, the geologic definition does not require that the water flow
to the surface, or that, as FDA proposed (58 FR 393 at 398), the water
level stand above the natural water table. Because the agency intended
that its definition for ``artesian water'' be the geologic definition,
it is revising the definition of artesian water in
Sec. 165.110(a)(2)(i) to state that bottled water that is drawn from a
well tapping a confined aquifer in which the water level stands at some
height above the top of the aquifer may be called ``artesian water'' or
alternatively ``artesian well water.''
Concerning artesian water that flows to the surface, FDA notes that
a typical geologic definition states that ``if the water level in an
artesian well stands above the land surface, the well is a flowing
artesian well'' (Ref. 5). The agency would not object to manufacturers
labeling their products accordingly, as long as it is done in a
truthful and nonmisleading manner. However, the name of the food
remains ``artesian water'' or ``artesian well water.''
18. One comment urged that the specific name ``artesian well
water'' be permitted on labels instead of ``artesian water'' to provide
full disclosure to consumers.
FDA advises that both ``artesian well water'' and ``artesian
water'' can be used to identify this product because both terms
appropriately describe it, and consumers would recognize either term.
``Artesian water'' does indeed come from a well and only differs from
``well water'' in that the water comes from a confined aquifer where
the water is under pressure and stands at some height above the top of
the aquifer. Therefore, FDA is modifying Sec. 165.110(a)(2)(i) to state
that the name of water from a well tapping a confined aquifer in which
the water level stands at some height above the top of the aquifer may
be ``artesian water'' or ``artesian well water.''
19. One comment asked how someone who is reviewing the label
statement ``artesian well water'' will be able to verify that the well
is actually an artesian well, meeting the definition, after the well
has been bored and is in production.
The agency agrees that there must be some means of verifying food
labeling claims. In specific instances FDA may require that records or
other means of verification be provided to FDA regulatory officials,
despite the act's lack of express, general statutory records access
authority for foods. The Supreme Court has recognized that FDA has
authority that ``is implicit in the regulatory scheme, not spelled out
in haec verba'' in the statute. Weinberger v. Bentex Pharmaceuticals,
Inc., 412 U.S. 645, 653 (1973). Indeed, ``it is a fundamental principle
of administrative law that the powers of an administrative agency are
not limited to those expressly granted by the statutes, but include,
also, all of the powers that may fairly be implied therefrom. * * * In

[[Page 57083]]
the construction of a grant of powers, it is a general principle of law
that where the end is required the appropriate means are given and that
every grant of power carries with it the use of necessary and lawful
means for its effective execution.'' (See Morrow v. Clayton, 326 F.2d
35, 44 (10th Cir. 1963).)
Under section 701(a) of the act (21 U.S.C. 371(a)), the agency may
promulgate regulations for the efficient enforcement of the act.
Although it is possible to determine that a source of water is an
artesian well after the well is in operation, in some cases it would be
onerous for regulatory officials to do so. Therefore, FDA has
determined that a verification requirement is necessary for the
efficient enforcement of the act. FDA has previously stated that a food
manufacturer is responsible for the accuracy of its food labels (58 FR
2079, 2163, and 2165, January 6, 1993). Indeed, placing a claim in food
labeling that calls the consumer's attention to a water's source is a
representation that the manufacturer has evidence that the product
meets the requirements for the claim. See Thompson Medical Co., Inc. v.
FTC, 791 F.d. 189, 193 (D.C. Cir. 1986), cert. denied, 479 U.S. 1086
(1987). Making a claim without such a basis would be misleading, in
violation of section 403(a) of the act.
The agency anticipates that, in some instances, companies will be
amenable to demonstrating to FDA the basis for the claim, regardless of
the existence of these regulations. The agency considers, however,
that, when a product bears a claim based on information available
solely to the manufacturer, it is reasonable for the agency to have
access to that information. See United States v. An Article of Device,
731 F.d. 1253, 1261-62 (7th Cir. 1984) (upholding regulation requiring
makers of prescription devices to be able to prove that their devices
work safely for their intended purposes and stating that ``[w]here the
government's access to the necessary information may be limited * * *
it seems not inappropriate to put the burden of persuasion on the party
who * * * presumably has better access to the relevant information'');
see also Trans-American Van Service, Inc. v. United States, 421 F.
Supp. 308, 331 (N.D. Tex. 1976). Therefore, FDA is modifying
Sec. 165.110(a)(2)(i) to require that plants be able to demonstrate to
regulatory officials that the water level of the well stands at some
height above the top of the aquifer, and, thus, that the well is an
artesian well. Compliance with this provision does not entail the
creation of any new information or the compilation of any special
records. Rather, the requirement would obligate manufacturers simply to
have access to information that they should already possess, or to make
a measurement of their well, and to provide FDA with this information.
FDA considers this requirement to be the logical outgrowth of its
January 1993 proposal. The purpose of this rulemaking is to ensure that
terms such as ``artesian water'' are used in a manner that promotes
honesty and fair dealing (see section 401 of the act (21 U.S.C. 341)).
Such a result requires not only that these terms be appropriately
defined, but that they be used in a manner that accurately describes
the product. Thus, how FDA would enforce the definitions was a matter
that was within the purview of the proposal, and that the agency would
provide for such enforcement in the final rule in this proceeding was
reasonably foreshadowed by the proposal. The fact that FDA received
comments on how it would ensure that the defined terms are
appropriately used evidences that this issue is the logical outgrowth
of the proposal.
To comply with this requirement, producers may maintain records
that demonstrate that the well is indeed an artesian well. The
manufacturer may also rely on records from the company that drilled the
well. In addition, many States and the United States Geological Survey
have records of some wells and of the geology of the surrounding area.
To verify that the water is at some height above the top of the aquifer
and is, thus, artesian water, the pump may be shut off, and the height
or the pressure of the water in the drilled hole measured. This
information can then be used, along with information on the depth of
the aquifer, to determine whether the water is artesian water. If the
source does not meet the definition of artesian water, the product must
not be labeled as artesian water, or it is misbranded under sections
403(a), 403(b), and 403(g) of the act.
20. One comment stated that water chemistry changes as wells are
pumped, and that the larger the drawdown, the greater the water
chemistry may change. It stated that a mineralogical analysis from a
water sample taken at 10 gallons per minute (gpm) may be quite
different than one taken at 500 gpm for the same well. The comment
added that there would be an ongoing burden on FDA to verify that water
produced by bottlers drawing on ``artesian'' groundwater resources
remains constant in water chemistry.
FDA agrees with the comment. The use of external force may alter
the physical properties, composition, and quality of the water,
although usually not significantly, depending on the rate of
extraction, because of changes in the pressure of the water as it is
extracted. This fact is the basis on which the agency proposed to
require that the use of external force not alter these characteristics
(58 FR 393 at 398). However, because the rate of extraction from the
use of external force could vary from day to day or even hour to hour,
the characteristics of the water can be also altered.
As discussed in the previous comment, the agency is requiring that
the manufacturer demonstrate that the source of the water is indeed an
artesian source. However, the agency does not deem it necessary to
require that the definition for artesian water extend to the physical
properties, composition, and quality of the water. In fact, as long as
the source is demonstrated to be an artesian source that meets the
definition in Sec. 165.110(a)(2)(i), the actual characteristics of the
water are a quality control concern for the manufacturer rather than an
attribute that defines artesian water. As stated previously, the agency
intends that its definition of artesian water be the geological
definition. The geological definition does not take into consideration
the composition of the water. Therefore, the agency is removing the
requirement in Sec. 165.110(a)(2)(i) that the use of external force in
the extraction of artesian water not alter the physical properties,
composition, and quality of the water.
2. Mineral Water
The agency proposed that water coming from a source tapped at one
or more bore holes or springs, originating from a geologically and
physically protected underground water source, may be called ``mineral
water.'' FDA further proposed that mineral water be distinguished from
other types of water by its constant level of minerals and trace
elements at the point it emerges from the source.
The agency tentatively concluded in the proposal that it would be
contradictory for bottled water that has essentially no minerals and
does not perform (e.g., taste) like mineral water to be labeled as
mineral water. Consistent with this tentative conclusion, FDA proposed
that ``mineral water'' be defined as water containing not less than 250
ppm TDS. The agency requested comments on the proposed minimum level of
250 ppm TDS in mineral water and stated that if it received substantive
data to support another minimum level, it would consider issuing a
final rule with a different minimum level.

[[Page 57084]]

21. A number of comments objected to FDA establishing a minimum TDS
level for mineral water. The comments argued that establishing such a
level would be arbitrary and contrary to the most current mineral water
definitions, including international definitions which do not include a
minimum level, and would prohibit many brands from being labeled as
mineral water, thereby adversely affecting consumer sales with no
apparent benefit to consumers.
Conversely, other comments suggested raising the minimum TDS level
to 500 ppm. These comments argued that establishing the minimum TDS at
the higher level would: (1) Make it closer to the definition that has
been adopted by most States that have bottled water regulations and to
the definition that is currently being considered by the Canadian
Government; (2) provide the basis for identification of the term
``mineral water'' with the distinctive taste of a higher mineral
content; (3) be less confusing to consumers in that it would not allow
the same water to be marketed under several names (e.g., ``mineral
water, low mineral content'' or ``spring water''); and (4) simplify
application of the quality standards and the label identity statement.
Several comments expressed the view that mineral water is ground
water with at least 50 ppm TDS, while several other comments supported
the proposed minimum level of 250 ppm TDS in mineral water. One of
these comments stated that waters having a TDS of 250 ppm or more
generally have a distinctive flavor. Two comments, however, stated that
actual taste thresholds for mineral water are often in the range of 100
ppm TDS. One of these comments stated that consumer identification and
differentiation among the flavors of various individual source waters,
which result from naturally occurring mineral variations in the water,
is clearly possible below the proposed threshold of 250 ppm TDS.
The agency acknowledges that many different definitions exist for
``mineral water.'' In the January 1993 proposal, the agency compared
several current definitions, including State and European standards, in
arriving at its proposed definition (58 FR 393 at 396). International
standards vary from requiring at least 500 ppm TDS (Canadian Province
of Quebec) to no minimum requirement (ERCS). In a like manner,
different States have different requirements. Therefore, no FDA action
will harmonize existing State and international regulations.
As stated in the proposal (58 FR 393 at 397), the minimum level of
250 ppm TDS for mineral water is based on the apparent consumer
expectation that a product identified as ``mineral water'' will contain
at least a minimum level of minerals. The agency tentatively concluded
that it would be misleading for bottled water that has essentially no
minerals, and that does not perform (e.g., taste) like mineral water,
to be labeled as mineral water. The minimum level that FDA proposed,
250 ppm TDS, is in agreement with the Association of Food and Drug
Officials (AFDO) definition (Ref. 7) for light mineral water and
mineral water.
The main characteristic of mineral water is, as its name implies,
the presence of a significant quantity of minerals. Other important
characteristics (Ref. 8) are that it be from a geologically and
physically protected underground water source, and that it contain a
constant level of minerals and trace elements at its point of emergence
from the source. Mineral water may come from a spring or a well,
including an artesian well, but must contain a significant amount of
minerals. The agency considers 250 ppm TDS as a significant amount of
minerals because at this level, the minerals, depending on the specific
mineral content, begin to impart a particular taste to the water.
Although minerals may impart some taste below this level, it is not the
significant mineral taste that is characteristic of mineral water.
FDA recognizes that mineral water from a spring that contains
between 250 and 500 ppm TDS may be identified as ``spring water,''
``mineral water, low mineral content,'' or both. However, FDA disagrees
that the availability of these terms will cause consumer confusion
because such a product meets the definitions of both ``mineral water''
and ``spring water'' in Sec. 165.110(a)(2)(iii) and (a)(2)(vi), and
both terms appropriately describe the product. As discussed previously
(see comment 14 of this document), use of all applicable terms
presented prominently on the label in the statement of identity is
appropriate because it will ensure the informativeness of the statement
of identity.
FDA realizes that brands previously sold as ``mineral water'' that
contain less than 250 ppm TDS will not be provided for under
Sec. 165.110 as ``mineral water.'' However, the brands mentioned in the
comments are not being sold in the United States as mineral water but
as other types of bottled water (e.g., spring water) because of the
many State requirements that mineral water contain greater than 500 ppm
TDS. Thus, although some of these brands cannot be labeled as ``mineral
water,'' other brands that previously could not be labeled as ``mineral
water'' and sold in some States now meet the definition of ``mineral
water'' in Sec. 165.110(a)(2)(iii) and can be labeled and sold as such.
Moreover, the agency has not been persuaded that this regulation
will adversely influence consumer sales or put some bottled mineral
water producers at a disadvantage as compared to others. The comments
did not provide any information on such adverse consequences, and the
agency is not aware of these adverse effects.
Therefore, for the reasons discussed above, FDA concludes that
establishing a minimum level of TDS in mineral water is reasonable, and
that the proposed level of 250 ppm TDS is the appropriate level.
22. One comment remarked that some bottled waters would not
significantly differ from a mineral water slightly above the 250 ppm
TDS minimum. Another comment stated that if companies wish to market
their products on the basis of the mineral content, they can do so
through a TDS disclosure statement on the principal display panel
regardless of the amount present. Therefore, there would be no need to
establish a minimum TDS level for mineral water.
Several comments declared that each mineral water product is unique
because of its particular composition of minerals, and that this unique
character imparts distinctive flavor. These comments stated that some
water products with a constant mineral content of less than 250 ppm TDS
might have a distinctive flavor and should be called ``mineral water--
very low mineral content'' or ``mineral light.''
Comments also stated that establishing a level of 250 ppm TDS is
contrary to the industry's belief that the overall mineral content is
less important than the level of each particular mineral.
The agency agrees that some waters that contain slightly less than
the 250 ppm TDS minimum would not significantly differ from a mineral
water slightly above the minimum. Any minimum level that the agency
establishes will preclude some waters from bearing the term ``mineral
water'' even though they do not vary significantly from waters that are
above the minimum. FDA also agrees that there is a taste aspect to the
presence of minerals, although some minerals may contribute a more
distinct flavor to the water than others. For example, in sufficient
amounts, sodium chloride gives water a salty taste, and sulfate
contributes a bitter taste (Ref. 5). In fact,

[[Page 57085]]
a common industry practice is to add minerals to some bottled waters
for the flavor that they contribute.
However, a minimum requirement for TDS is necessary to ensure that
when consumers purchase a product labeled as ``mineral water,'' the
product contains minerals at a level that justifies calling the product
by that name. As explained in response to the previous comment, that
level is 250 ppm TDS. The minimum TDS requirement for mineral water
will not preclude a product that contains less than 250 ppm TDS from
being marketed under another name, such as ``ground water,'' ``spring
water,'' or ``well water,'' as applicable, or from being called
``bottled water.'' In addition, manufacturers may include a truthful
statement of the TDS level on the label of any bottled water product.
Thus, even though FDA has carefully considered these comments, it
concludes that it is appropriate to establish a minimum TDS requirement
for ``mineral water.''
23. One comment stated that the definition for ``mineral water''
should include all water containing over 500 ppm TDS and argued that
whether it occurs naturally or is constructed (as are other food
products) is irrelevant. The comment added that if mineral solids are
added, FDA should require that such additions be noted on the label.
Another comment stated that it is essential that the definition be
clear that mineral water may not be altered by the addition or deletion
of minerals. The comment stated that mineral water should not be water
that is derived from a public water supply and to which minerals are
then added.
FDA disagrees with the comment that advocated that water to which
minerals have been added should be eligible to be called ``mineral
water.'' The agency has reviewed a number of State and foreign
standards, and none define ``mineral water'' as containing added
minerals (Ref. 8). In fact, many of these standards define water with
added minerals as a different type of bottled water, distinct from
``mineral water.'' Therefore, the agency concludes that the definition
for ``mineral water'' should not be revised to permit the addition of
minerals.
The agency agrees with the comment that stated that the addition of
minerals should be clearly prohibited in the definition for mineral
water. The definition for mineral water has geological as well as
compositional factors. The amounts and types of minerals in mineral
water is a result of the path that the water has traveled underground.
Therefore, to clarify that the minerals present in mineral water must
be from the underground source and not added to the water after
extraction, FDA is modifying the definition of mineral water in
Sec. 165.110(a)(2)(iii) to specifically preclude the addition of
minerals.
However, some mineral waters as extracted from their geological
source, may contain high levels of some undesirable minerals (e.g.,
arsenic, precipitated manganese). In some instances, the water can be
treated to selectively remove these undesirable elements. FDA is aware
of no reason why it should preclude the removal of these undesirable
elements, or why such removal should preclude the manufacturer from
labeling the product as ``mineral water'' as long as all other
requirements (e.g., source and composition) of the definition are met.
Section 165.110(a)(2)(iii) provides accordingly.
24. Several comments requested that FDA more precisely define
``mineral water'' in that the agency should require that the level and
relative proportions of minerals and trace elements remain constant.
Comments stated that such a requirement would harmonize the definition
of mineral water with the European Community and Codex concepts. These
comments suggested the following definition: ``Mineral water shall be
distinguished from other types of water by its constant level and
relative proportions of minerals and trace elements, at the point of
emergence from the source, due account being taken of the cycles of
natural fluctuations.'' One comment added that this wording recognizes
that minor natural fluctuations occur with any source water.
Some comments requested that the agency clarify that, in the term
``constant level of minerals,'' the ``level'' is not the characteristic
element. They stated that what is fundamental is the ``constancy'' or
``stability'' of the mineral composition, which acts more as a
fingerprint of the water rather than as a measure of the overall total
dissolved solids content.
One comment stated that all ground water (well or spring) has a
constant level of minerals and trace elements as it emerges from the
source. The comment questioned the scientific basis of FDA's approach.
The agency agrees that it needs to clarify its definition of
mineral water. In the proposal (58 FR 393 at 396), FDA stated that
mineral waters may have very different flavors depending on the mineral
content and types of minerals and trace elements present in the water.
Consumers may purchase a particular mineral water from a particular
source because of the flavor contributed by the mineral content. It is
important to consumers that the mineral composition of a particular
source remain constant. FDA considers that industry and consumers have
come to expect that mineral water has a fairly stable mineral
composition. Therefore, FDA proposed that mineral water be
distinguished from other types of water by the constant level of
minerals and trace elements in the water as it emerges from its source.
FDA further notes that the ERCS defines ``natural mineral water''
as being characterized by its content of certain mineral salts and
their relative proportions and by the presence of trace elements or
other constituents (Ref. 1). The ERCS also states that mineral water is
characterized by the constancy of its composition, the stability of its
discharge, and its temperature, due account being taken of the cycles
of natural fluctuations.
As stated previously, the composition and concentration of
substances dissolved in ground water depend on the chemical composition
of precipitation, on the biologic and chemical reactions occurring on
the land surface and in the soil zone, and on the mineral composition
of the aquifers and confining beds through which the water moves (Ref.
5). Thus, under constant conditions, the mineral content of ground
water will be constant. There are certain natural factors that may
affect the constancy of a source such as occurrence of earthquakes and
long term climatic changes. These natural factors do not preclude the
water from qualifying as mineral water as long as the water continues
to meet the compositional requirements in Sec. 165.110(a)(2)(iii).
Therefore, to clarify the importance of the relative proportion of
minerals and trace elements, and to take into account the cycles of
natural fluctuations, FDA concludes that modification of the definition
of mineral water, along the lines requested by the comments, is
appropriate. The modification reflects the fact that there may be some
minor variation in mineral water over time, and that absolute amounts
of minerals in the water may change slightly. Thus, the agency is
modifying Sec. 165.110(a)(2)(iii) to state that mineral water shall be
distinguished from other types of water not only by its constant level
of minerals and trace elements at the point of emergence from the
source, but also by its relative proportions of these substances, due
account being taken of the cycles of natural fluctuations. Natural
fluctuations in mineral content may occur, but these fluctuations must
not affect the relative

[[Page 57086]]
proportions of minerals and trace elements. Samples of mineral water
can be compared to ensure that major dissolved mineral contents are the
same using several scientific methods, such as the Stiff diagram and
the Piper trilinear diagram (Ref. 9).
25. Two comments urged FDA to amend the proposed definition for
``mineral water'' to require that if mineral water is taken from a bore
hole tapping a spring, it be from the same underground stratum, and be
of the same quality and composition, as the water derived from the
natural orifice.
The comments seem to be arguing that any product drawn from a
spring must meet the requirements for ``spring water.'' However, this
is not the case. A product need only meet the requirements for the term
used to name it. Thus, a product labeled as ``mineral water'' need only
meet the requirements in Sec. 165.110(a)(2)(iii). It need not meet the
definition for ``spring water'' unless its label claims that the water
is also spring water. If the product were, however, to claim to be
``mineral spring water,'' it must meet the definition of spring water
in Sec. 165.110(a)(2)(v) as well as that for ``mineral water.''
26. One comment noted that the proposed definition of mineral water
refers to water ``* * * originating from a geologically and physically
protected underground water source.'' The comment stated that this
phrase appears to be ambiguous and meaningless because there is no
indication in the definition of what would constitute protection. It
stated that the terminology seems to offer the consumer some assurance
of purity that may not be warranted. The comment asserted that every
ground water source inherently possesses some degree of geologic and
physical protection by the very fact that it is underground. It stated
that there are no operational means to differentiate a protected
underground water source from an unprotected one.
The agency agrees that every ground water source inherently
possesses some degree of geologic and physical protection by the very
fact that it is underground. However, some underground water sources
are not protected. This lack of protection is evidenced by the fact
that some underground sources are under the direct influence of surface
water. As discussed earlier (see comment 12 of this document), EPA
defines ground water under the direct influence of surface water as any
water beneath the surface of the ground with: (1) Significant
occurrence of insects or other macroorganisms, algae, or large-diameter
pathogens such as Giardia lamblia; or (2) significant and relatively
rapid shifts in water characteristics such as turbidity, temperature,
conductivity, or pH that closely correlate to climatological or surface
water conditions (40 CFR 141.2).
The latter part of EPA's definition pertains to changes in the
physical characteristics of the water. Changes in these physical
characteristics can have a significant influence on the mineral
composition of the water. Because the definition of ``mineral water''
is geological as well as compositional, the agency concludes that it is
important that ``mineral water'' be from a physically protected
underground water source. Mineral water has been traditionally
distinguished from other types of water by its constant level, and
relative proportions, of minerals and trace elements at the point of
emergence from the source, due account being taken of the cycles of
natural fluctuations. This distinction is a reflection of the fact
that, traditionally, the mineral composition of products labeled as
mineral water does not vary significantly over time. Therefore, it is
important that mineral water come from a geologically protected
underground source, so that the mineral water retains its distinctive
mineral content.
FDA does not agree, however, that there are no operational means to
differentiate a protected underground water source from an unprotected
one. The presence of insects or other macroorganisms as well as changes
in physical characteristics are measurable. Thus, regulatory officials
can determine whether mineral water is from a geologically and
physically protected underground source.
27. One comment stated that the label statement ``mineral water''
will lead some consumers to believe that the food contains a
nutritionally significant amount of minerals. It stated that this
perception will occur even if the food is labeled ``low mineral
content,'' because ``low'' is a relative term and not a quantitative
term. Therefore, the comment asserted that all bottled water labeled as
``mineral water'' should also bear nutrition labeling or a statement
such as, ``Not a significant source of ________________,'' with the
blank being filled in with the names of any essential minerals that are
missing or present in insignificant amounts.
One comment asked whether the statement of identity for ``mineral
water'' or ``mineralized water'' would constitute a health claim and,
thus, trigger full nutrition disclosure, even in abbreviated form.
Another comment stated that use of the term ``mineral water'' should
not require additional nutrition information.
The agency stated in the preamble to the January 1993 proposal (58
FR 393 at 404), that its tentative view was that nutrition labeling
should appear on bottled water labeled as ``mineral water, high mineral
content'' because consumers may assume that water with a high mineral
content would be of nutritional benefit. In addition, mineral water
with a high mineral content could contain enough sodium, calcium, or
iron to make nutrition labeling mandatory. Under Sec. 101.9, foods that
contain more than an insignificant amount of the nutrients or food
components that are required to be listed, or whose label, labeling, or
advertising contains a nutrient content claim or any other nutrition
information, must bear nutrition labeling.
Nutrients likely to be present in bottled water products in amounts
that could trigger nutrition labeling are calcium, sodium, and iron. If
any of these minerals are present in a product in more than
insignificant amounts, nutrition labeling is required under section
403(q) of the act. More than an insignificant amount of calcium is 20
mg or more per labeled serving, more than an insignificant amount of
sodium is 5 mg or more per labeled serving, and more than an
insignificant amount of iron is 0.36 mg or more per labeled serving
(Sec. 101.9(c)(8)). The reference amount customarily consumed for
bottled water is 240 milliliter (mL) (Sec. 101.12(b)).
The agency has considered whether the term ``mineral water'' is an
implied nutrient content claim, and whether, as a result, nutrition
labeling should be mandatory on any product labeled as ``mineral
water'' regardless of the level of required nutrients. In the Federal
Register of January 6, 1993 (58 FR 2302 at 2369), the agency concluded
that when an ingredient constitutes essentially 100 percent of the
food, so that the name of the ingredient is the statement of identity,
the name of the ingredient does not constitute an implied nutrient
content claim, even though in other contexts, reference to the
ingredient could constitute such a claim (see Sec. 101.65(b)(4)). For
example, when the name of the ingredient constitutes the common or
usual name of the product, as described in Sec. 102.5 (21 CFR 102.5),
or the identity of the commodity, as described in Sec. 101.3 (e.g.,
``canola oil''), it is not a nutrient content claim. In such a context,
the name of the ingredient does not imply that a nutrient is present in
a certain amount, but rather, it describes the nature of the

[[Page 57087]]
product. However, the claim ``made only with canola oil'' does
characterize the level of a nutrient in the food. This claim represents
an implied claim that the food is low in saturated fat
(Sec. 101.65(c)).
The term ``mineral water,'' when used as the statement of identity
of the food, does not trigger nutrition labeling because it does not
make a representation, either explicit or implied, about the level of
nutrients in the food. ``Mineral water'' is simply the name of the
food. Although the term ``mineral water'' indicates that the water
contains a significant amount of minerals, it does not imply that these
minerals are nutrients. In fact, not all of the total dissolved solids
in mineral water are nutrients (e.g., bicarbonates). However, labeling
claims that imply the presence or absence of any nutrient in bottled
water would trigger nutrition labeling.
The major dissolved inorganic constituents of ground water are
sodium, magnesium, calcium, chloride, bicarbonate, and sulfate. The
total concentration of these major ions comprises more than 90 percent
of the TDS in the water (Ref. 9). The presence of 83 ppm calcium or 21
ppm sodium or more will trigger nutrition labeling. Therefore, because
mineral water must contain at least 250 ppm TDS, it is likely that many
mineral waters, especially high-mineral-content mineral waters, will
contain enough calcium or sodium that the labels of these products must
bear nutrition labeling.
The agency does not agree with the comment that asserted that
consumers will be led to believe that the food is a significant source
of minerals if the food is labeled ``low mineral content.'' Use of the
term ``low'' does not suggest that minerals are present in a
significant amount. The term ``low,'' as used in the statement of
identity of the product, is not used in a dietary context. It is simply
a qualitative term used as part of the name of the food to describe the
food. Thus, use of the term ``low mineral content'' would not indicate
that the mineral water was a significant source of minerals.
Therefore, for the reasons discussed above, FDA concludes that
consumers will not be misled that mineral water contains more than a
nutritionally insignificant amount of minerals, and nutrition labeling
of all mineral water is not required.
28. Several comments stated that the product should be labeled as
``inorganic mineral water'' because all minerals found in water are in
an inorganic state. They stated that the inorganic minerals found in
water are only substances that have been dissolved by the water itself.
The comments stated that fruits or vegetables take in inorganic
material through their roots to become organic and readily accepted by
the body's cells. They stated that not labeling the product as
``inorganic mineral water'' is misleading to consumers. Additionally
the comments noted that many of the so-called ``minerals'' found in
mineral water are not minerals at all but are in fact inorganic
chemicals. They urged FDA to require the label to read: ``Inorganic
mineral & inorganic chemical content ________________ ppm TDS.''
FDA disagrees with the comment. Minerals by definition are
inorganic elements or chemicals in any food (Ref. 10). Thus, the term
``inorganic'' is not a material fact that must be disclosed in labeling
mineral water because the term ``mineral'' means that the water
contains inorganic chemicals. While the agency recognizes that some
minerals that are also nutrients may be more bioavailable in some foods
than in mineral water (e.g., calcium in milk), the comments did not
provide any data to substantiate their claim that inorganic nutrients
taken into plants systemically are more bioavailable than the same
nutrients in water.
In regards to a required label statement concerning TDS, as will be
discussed later in this final rule, FDA does not require that the TDS
appear on the label of any bottled water product, and the comments have
not provided substantive grounds to do so. However, firms may include
this information on the label of bottled water in a truthful and
nonmisleading manner, including in the manner suggested by the comment
if the firm so chooses.
3. Purified Water
The agency proposed that water that is produced by distillation,
deionization, reverse osmosis, or other suitable processes, and that
meets the definition of ``purified water'' in the most recent edition
of the USP, can be labeled as ``purified water.'' FDA also proposed
that if the water is produced by distillation and meets the USP
standard, alternatively it may be called ``distilled water.''
29. Two comments stated that the term ``purified water'' should not
be permitted on labels because consumers do not understand its specific
meaning and, thus, may be confused by the use of this term. They
requested that only the following specific names be permitted on labels
in order to give full disclosure to the consumer: ``Distilled water,''
``reverse osmosis water,'' and ``deionized water.''
FDA disagrees with these comments. The agency proposed that the
name ``purified water'' be defined as water that has been processed to
meet the requirements of the USP definition for ``purified water.'' An
alternative name for water processed by distillation and that meets the
USP standard is ``distilled water.'' ``Purified water'' and ``distilled
water'' meeting the USP definition have been marketed under these names
for many years, and the comments did not provide any evidence that
consumers do not understand the meaning of these terms. Therefore, the
agency is aware of no basis on which to conclude that these terms will
confuse consumers. The agency views this rulemaking as standardizing
the use of these terms, not introducing new terms into the market.
Manufacturers may include more specific information concerning the
method of preparation of these bottled water products on the label.
Therefore, the comments have not persuaded the agency to alter its
approach to the use of these terms.
However, the agency agrees that the terms ``reverse osmosis water''
and ``deionized water'' are appropriate alternative names for purified
water because these terms describe how water is processed to produce
purified or distilled water. Therefore, FDA is modifying
Sec. 165.110(a)(2)(iv) to provide for the alternative term ``deionized
water'' if the water has been processed by deionization, and ``reverse
osmosis water'' if the water has been processed by reverse osmosis.
30. Several comments objected to FDA's proposal that ``purified
water'' meet the USP definition because: (1) Water for human
consumption does not need to be pharmaceutical grade water; (2) USP
methods of analyses for bottled water are different from EPA and FDA
methods; and (3) the regulation would automatically adopt future
updates of the USP, thus, providing the publisher of the USP with
lawmaking power without any formal comment or review mechanism.
Comments asked that FDA delete any reference to the USP in
Sec. 165.110(a)(2)(iv). Some of the comments recommended that FDA
establish specific standards for purified water rather than adopt the
USP standard by reference.
One comment stated that a standard for purified drinking water
should require the use of ``distillation, deionization, reverse
osmosis, or other suitable processes'' and impose a water conductivity
testing requirement with a conductivity maximum allowable threshold
level of 30 microsiemen per centimeter. It stated that the conductivity
test, which would measure

[[Page 57088]]
the ionic strength of water based on a customarily used reverse osmosis
system, would verify the purification process. Another comment stated
that ``purified water'' should only be required to meet the current USP
requirements for total solids, pH, and chloride.
FDA is persuaded by the comments that the definition of purified
water should not be bound ``to the most recent'' USP standard as it
proposed to do. However, the agency does conclude that the definition
should use the USP standard because purified water meeting this
standard has been sold for years and is an established product.
Although water for human consumption does not need to be pharmaceutical
grade, water that is labeled as ``purified water'' should meet stricter
standards than other types of bottled water because the term
``purified'' asserts that the product has been processed to be of a
purer quality than other types of water. Therefore, requiring that
``purified water'' meet a USP definition ensures that the water meets a
stricter standard than other types of bottled water.
FDA recognizes that it would be a burden for manufacturers
producing purified water and other types of bottled water to have to
use different methods of analysis (USP and EPA) to test for the same
contaminant. Bottlers may use EPA methods to test their purified water,
although the agency notes that it will use USP methods to check for
compliance. However, FDA points out that most of the USP methods do not
provide a numerical water quality requirement that would parallel EPA
methods but instead require testing with a positive or negative result.
Thus, the methods may not be easily interchangeable.
FDA concludes that the requirement should remain as proposed
because the term ``purified water'' explicitly asserts that the water
has been purified, and the USP definition is a commonly used standard
for what constitutes purification. This common use is evidenced by the
fact that AFDO's definition of ``purified water'' is the USP definition
(Ref. 7). However, FDA agrees that interested persons should have an
opportunity to comment on any proposed change in the standard of
identity for purified water. Therefore, FDA is referencing a specific
edition of the USP monograph in the definition of ``purified water''
(Sec. 165.110(a)(2)(iv)). The agency is defining ``purified water'' as
water that has been produced by distillation, deionization, reverse
osmosis, or other suitable processes and that meets the definition of
purified water in the USP, 23d Revision.
The agency notes that the USP is in the process of updating its
monograph for purified water. One such revision may be a water
conductivity test requirement as mentioned by one of the comments. As
modifications are made to the USP definition, FDA will consider
amending its definition for purified water to reflect the modification.
The agency notes that any bottled water that is labeled as
``purified water, USP,'' or that indicates in any manner that the
product meets USP specifications, must, in addition to complying with
FDA regulations, meet the most recent USP standard, or the product will
be misbranded under section 403(a)(1) of the act in that its labeling
will be false in this particular.
31. One comment asked that FDA explicitly designate the product as
``purified drinking water'' and, as a food product, differentiate it
from ``purified water, USP'' usable for pharmaceutical purposes. The
comment stated that a change in nomenclature from ``purified water'' to
``purified drinking water'' would reduce any potential for confusion
between purified water that is suitable for use in preparation of
compendial dosage forms and purified drinking water for potable
purposes. It stated that the qualification would make clear to the
public that products labeled as ``purified drinking water'' are not
represented as, and do not purport to be, in compliance with the USP
monograph for ``purified water.''
The agency disagrees that the term ``purified water'' should be
replaced by ``purified drinking water'' in the standard of identity.
Many products that are currently being sold as ``purified water'' for
drinking purposes meet the USP definition for ``purified water,'' and
FDA is not aware of any evidence of public confusion. Thus, FDA
concludes that ``purified water'' remains an appropriate name.
However, ``purified drinking water'' and ``distilled drinking
water'' are appropriate alternative names for the product because these
names will enable consumers to identify the product as water for
drinking purposes that has been processed to meet stricter purity
standards. Therefore, FDA is modifying Sec. 165.110(a)(2)(iv) to
provide for alternative terms that describe the product as a type of
drinking water (e.g., ``purified drinking water'').
32. One comment recommended that FDA establish a definition for
``demineralized water'' as follows: ``The name of water demineralized
by distillation, reverse osmosis, or other method so that it contains
not more than 10 ppm TDS may be `demineralized water.' ''
The agency agrees that ``demineralized water'' is an appropriate
name for water that has been processed to significantly decrease its
mineral content. However, FDA concludes that there is no need to
establish a separate definition for ``demineralized water'' because the
USP definition for ``purified water'' encompasses water that has been
demineralized by distillation, reverse osmosis, or other method and
that contains not more than 10 ppm TDS. Therefore, the agency is
including the term ``demineralized water'' as an alternative name for
``purified water'' in Sec. 165.110(a)(2)(iv).
33. One comment recommended the establishment of a heterotrophic
bacteria standard for purified water. It stated that, although the
health risks from such bacteria may be small, a higher expectation
exists for a product labeled as ``purified'' than for other bottled
water products. The comment stated that purified water is purchased by
immunosuppressed individuals, contact lens wearers, mothers of small
infants, laboratories, and others with an expectation of purity from
general bacteria. The comment recommended a limit of no more than 500
bacteria per milliliter for purified water because this standard will
limit the suppression of coliform detection and reduce the exposure and
dosage level for organisms that might have a health effect on at- risk
groups. The comment also recommended that, if FDA does not establish a
general bacteria standard for ``purified water,'' the agency substitute
the name ``demineralized water'' for ``purified water'' so as not to
mislead consumers.
FDA disagrees with the comment. Traditionally, water that is
essentially free of chemical impurities is called ``purified water,''
and water that is free of microorganisms is called ``sterile'' or
``sterilized water.'' This distinction is evidenced by the fact that
there are USP monographs for ``sterile water'' and for ``purified
water'' that distinguish between the two types of water (Ref. 6). Thus,
the labeling of a product as ``purified water'' does not imply that it
is sterile water.
USP has established a general guideline for purified water for
pharmaceutical purposes of 100 colony-forming units per mL. This level
evidences that the water has been treated appropriately, even though
bacteria are present at low levels. Purified water that has been
treated by distillation or reverse osmosis may be sterile if
appropriately processed. However, the agency points out that

[[Page 57089]]
purified water is typically low in the nutrients required by
microorganisms for growth, and, thus, ordinarily has low bacterial
counts. Adherence to the regulations in part 129 significantly reduces
the risk of contamination. Therefore, ``purified water,'' if
appropriately processed as required by part 129, should contain less
than the comment's requested 500 bacteria per mL. The agency
consequently concludes that the establishment of a bacterial standard
for ``purified water'' is not necessary.
The agency is defining ``sterile water'' in this final rule. Use of
this term in the statement of identity of qualifying bottled waters
will allow consumers desiring to purchase water that is
bacteriologically pure to easily identify this type of water and to
distinguish it from purified water that is chemically pure.
4. Spring Water
FDA proposed that bottled water derived from an underground
formation from which water flows naturally to the surface of the earth,
or would flow naturally to the surface of the earth if not for its
collection below the earth's surface, may be called ``spring water.''
The agency proposed to provide for the collection of spring water only
at the spring or through a bore hole adjacent to the point of
emergence. FDA also proposed that spring water collected with the
assistance of a bore hole to protect the water shall be from the same
underground stratum as the spring and shall retain all the physical
properties and be of the same composition and quality as the water that
flows naturally to the surface of the earth or that would flow
naturally to the surface of the earth if not for its collection below
the earth's surface. FDA requested comments from interested persons
concerning the definition for ``spring water'' and on the use of a bore
hole adjacent to the point of emergence of the spring to facilitate
collection of the water.
a. Consumer Surveys
34. Two comments included consumer telephone surveys, each
conducted by a different bottled water producer, that addressed issues
of consumer understanding and preferences for bottled water labeled as
``spring water.'' A number of subsequent comments pointed to
methodological shortcomings in one or the other of the two consumer
surveys, including inadequate sample size, nonrepresentative sampling,
ambiguous and biased question wording, failure to counterbalance order
of questions, improper survey approach, and flawed interpretations of
results.
The agency recognizes that such problems exist to some extent in
both studies, as they do in virtually all survey studies, but it is not
convinced that there is sufficient basis for dismissing the results of
these studies. Each study has some merit, and there is a surprising
degree of agreement between the two studies in their primary findings.
Therefore, FDA finds that both studies provide useful information
concerning consumer opinions on spring water, and that it is
appropriate to use this information in arriving at a definition for
``spring water.''
35. The principal concern of both surveys, and the primary subject
of comments about the respective survey results, was an attempt to
describe consumer understanding of the use of the term ``spring water''
with respect to the method of extraction, bore hole or surface
collection, used to obtain the water. In study 1 (C302 in this docket),
respondents were asked about which extraction method they would expect
would be used to collect a product called ``spring water.'' In study 2
(MM5 in this docket), respondents were asked which extraction method is
used to collect ``spring water.''
Many comments criticized one or the other of the studies for the
way the different methods of extraction (borehole or surface
collection) were described to respondents, usually alleging that the
wording introduced a bias in respondents' answers. In study 1, for
example, surface extraction was described as ``water that flows
naturally to the surface,'' and bore hole extraction was described as
``water pumped * * * through a bore hole.'' In study 2, surface
extraction was described as ``water taken from springs whose water is
captured above ground level,'' and bore hole extraction was described
as ``water taken from springs whose water is captured below ground
level.''
FDA agrees that biases were introduced by the wording of these
questions. However, despite the difficulties in communicating to
consumers about methods of extraction for spring water in a telephone
survey, the results of both surveys show that there is considerable
uncertainty among consumers about which extraction method is or should
be used for spring water.
Study 1 asks the question, ``When you see spring water on the label
of a bottle, which of the following describes the water you would
expect to be in the bottle?'' in a forced-choice form such that ``not
sure'' answers are not allowed. Although 54 percent of respondents
responded that the water naturally flows to the surface, 46 percent of
respondents expressed the possibility that spring water was extracted
from a bore hole. In addition, even though the question context
strongly encouraged selecting one or the other of the alternatives
provided, 34 percent of respondents choose to answer ``either of the
above'' when asked which extraction method they would expect for spring
water. FDA considers this level of response to the ``either of the
above'' alternative to indicate considerable consumer uncertainty.
Because of the observed uncertainty, the study documents that there is
no consensus among consumers about how spring water is or should be
extracted.
In study 2, a ``not sure'' alternative was allowed for each of the
two yes/no questions, ``Is bottled spring water taken from springs
whose water is captured above the ground level?'' and ``Is bottled
spring water taken from springs whose water is captured below the
ground level?'' Forty one percent of respondents answered ``not sure''
to both questions, and an additional 13 percent answered ``not sure''
to one of the two questions. These responses mean that, overall, 54
percent of respondents indicated that they were not sure about the
extraction methods used for bottled spring water.
Given the high levels of consumer uncertainty about extraction
methods used for bottled water that were found in both studies, FDA
concludes that the issue of how spring water is or should be extracted
is not an issue to which many consumers have given much thought. At the
same time, however, FDA considers the finding that consumers have
limited opinions about the extraction methods used for bottled spring
water to be very relevant to its objective of developing bottled water
definitions that promote honesty and fair dealing in the marketplace.
The fact that consumers do not appear to be informed or concerned about
issues related to the extraction methods used for spring water suggests
that FDA has little reason to suggest major changes in the usage of the
``spring water'' designation on bottled water on the grounds of
promoting honesty and fair dealing in the marketplace. Currently, as
many comments stated, spring water products on the market are produced
using both methods of extraction. In addition, most State and
international definitions provide for both methods of extraction for
spring water (Comment 91 and Refs. 2, 7, 11, 12). Thus, FDA concludes
that the use of the term ``spring water'' does not imply a particular
extraction method, and that

[[Page 57090]]
providing for the use of either surface or bore hole collection of
spring water will not mislead consumers.
36. A number of comments cited survey results indicating that
consumers perceive that spring water has a higher quality and a better
taste than other kinds of bottled water, and that, therefore, consumers
are more likely to buy it. They argued that, because spring water has
greater consumer appeal, it is incumbent on FDA to ensure that the
definition of spring water is not misleading to consumers.
FDA agrees with these comments and with the conclusion, based
mainly on Study 1 findings, that consumers consider bottled water
labeled as spring water to be of a higher quality than other kinds of
bottled water. FDA notes, however, that the favorable state of consumer
opinion toward spring water has developed under circumstances in the
marketplace in which the term ``spring water'' has been used to
describe both water extracted at the surface and water extracted by the
bore hole method. Given that it has been extracted in both ways, with
apparent consumer satisfaction, how the water is extracted does not
appear to be the key factor.
There is a second aspect of the definition of ``spring water''--
from where the water comes. By the process of elimination, this factor
appears to be key. Thus, it is this aspect of the definition that FDA
has made most rigorous.
FDA concludes, therefore, that its requirement in
Sec. 165.110(a)(2)(vi) that bottled water labeled as ``spring water''
be from the same underground stratum as the spring and always have the
same physical properties, composition, and quality as water that flows
naturally to the surface of the earth, without specifying a necessary
method of extraction, will provide appropriate protection against use
of the term to mislead consumers about quality characteristics of
bottled water.
37. A number of comments, based principally on Study 2 findings,
argued that safety considerations were the primary consumer concerns
about bottled water, that FDA should take these concerns into account
when deciding on the appropriate definition of ``spring water,'' and
that these concerns provided a sufficient basis for including water
obtained by bore hole extraction in the definition of ``spring water.''
FDA agrees that safety considerations are important in the
regulation of bottled water. However, the agency does not generally
view the standard of identity for a product as the means to ensure its
safety. FDA stated in the proposed rule (58 FR 393) that it was
developing definitions for types of bottled water to ensure honesty and
fair dealing in the interest of consumers, and this remains the
agency's basic purpose for defining these terms.
FDA has established quality standards for bottled water to satisfy
consumer expectations that bottled water will be of appropriate
quality. To be of appropriate quality, the water must be safe. Thus,
the quality standard sets maximum levels that are well within safe
levels for a number of water contaminants. FDA has also adopted a good
manufacturing practice (GMP) regulation for bottled water to ensure
that bottled drinking water is processed, bottled, held, and
transported under sanitary conditions that will not render the product
injurious to health. Thus, regardless of the extraction method used to
obtain bottled water, the water will be safe.
For these reasons, FDA does not see consumers' concerns about
safety as a particular reason for including water that is obtained by
bore hole extraction in the definition of ``spring water.'' FDA is
including water obtained in this way in the definition because, as
explained above, bore hole collection of spring water is a common
industry practice, and consumers are not misled by the use of this
collection method. The key to the definition, as FDA stated in response
to comment 36 of this document is from where the water comes.
b. Use of a Bore Hole
38. A number of comments objected to a definition of ``spring
water'' that would allow the use of a bore hole to collect the water.
Comments stated that the definition would allow ``well water'' or
``bore hole water'' to be labeled as ``spring water.'' Comments
requested that the reference to bore hole extraction be deleted from
the proposed regulation because the water is not ``spring water.''
Some comments stated that ground water derived by the use of bore
holes is not compatible with the geological definition of a spring and
should not be permitted to be labeled as ``spring water.'' One of the
comments added that the proposed definition is inaccurate and does not
represent the common usage of this term by professional
hydrogeologists, professional ground water hydrologists, or the general
public. It stated that springs are naturally occurring discharges or
flows of ground water that occur at the land surface.
On the other hand, a number of comments argued that water extracted
through the use of a bore hole should be eligible to be called ``spring
water.'' Comments stated that a bore hole is a preferred method of
spring water collection, and that inclusion of this method of
collection in the definition of ``spring water'' would provide
flexibility to manufacturers. One comment from a hydrogeologist stated
that the use of bore hole collection methods is widely recognized
throughout the United States and the rest of the world as a safe,
convenient, sanitary, and reliable method for intercepting spring water
before it emerges to the earth's surface, where it can be exposed to
sources of pollution or alteration.
A number of comments noted that the use of bore holes has long been
recognized in this country, Canada, Europe, and elsewhere as a
preferred and sometimes necessary method for extracting spring water.
Comments stated that bore hole collection of spring water is practiced
exclusively in Europe and many other parts of the world for sanitary
reasons. Comments added that the proposed definition recognizes that
over 50 percent of the water used in domestic spring water production
is currently collected through the use of a bore hole, and that the
definition provides a consistent standard of identity regardless of the
technology used for extraction and collection.
One comment stated that some advance the view that spring water
collected at the surface is natural because its collection involves no
physical or technological intervention into, or development of, the
spring source or of the water, and that subsurface collection of spring
water is not natural because it involves extraction and piping through
a bore hole, which means that the finished product is produced through
physical alteration of, and intervention into, the source. The comment
said that this view is misleading because even when spring water is
collected at the surface, piping must be used, a bore must be drilled,
and technology must be employed in the collection process. The comment
said that frequently, physical alteration of the natural orifice also
must be undertaken.
The agency has decided to adopt the proposed definition of ``spring
water'' as water that is derived from an underground formation from
which water flows naturally to the surface of the earth. FDA has also
decided to provide that ``spring water'' may be collected below the
earth's surface through a bore hole. As previously discussed in
response to comment 35 in this final rule, consumers do not necessarily
believe that spring water is

[[Page 57091]]
collected at the surface of the earth. In addition, over half of the
spring water sold in the United States is extracted through a bore
hole. Therefore, the agency has concluded that providing for the use of
a bore hole in addition to surface collection will permit production
flexibility without interfering with established consumer understanding
or expectations in any way.
FDA recognizes that some geologists and hydrogeologists disagree
with the use of a bore hole in the collection of spring water. However,
FDA finds that as long as the physical properties, composition, and
quality of the water that is captured by a bore hole are the same as
those of the water from the same underground formation that flows to
the surface, it is appropriate to label the water as spring water. If
the use of a bore hole does not change the characteristics of that
water, then the bore hole is only tapping the underground water source
that feeds the spring. However, if the water collected through the bore
hole has different characteristics from the water emerging from the
spring orifice, the water is not spring water. To clarify that the
source of the water must be the same underground formation, the agency
is adding a provision to Sec. 165.110(a)(2)(vi) that the bore hole
collection of spring water must be through a bore hole tapping the
underground formation feeding the spring.
A spring is a natural flow of water from the earth (Ref. 13). An
aquifer is a porous rock stratum that yields water in a usable quantity
to a well or spring (Ref. 5). A stratum is a single layer of rock.
Spring water is water that emerges from the spring orifice or water
from the stratum that feeds the spring. Scientific field methods can
demonstrate that water that emerges from a spring and water from an
adjacent bore hole are from the same underground source. Geochemical
methods may be used to demonstrate that water extracted from a spring
and water extracted from an adjacent bore hole are of the same chemical
quality.
FDA agrees that there must be appropriate development of an
approved source, whether the water is to be collected at the natural
orifice or with the use of a bore hole. Both methods of collection
require careful engineering for proper water collection. A source must
be appropriately developed, in accordance with the GMP's in part 129,
to qualify as an approved source. Under Sec. 129.3(a), an approved
source is one that has been inspected by the State and local government
agencies having jurisdiction. Under Sec. 129.35(a)(1), the source must
be properly located, protected, and operated and be easily accessible
and adequate.
In summary, FDA finds that water that is collected by use of a bore
hole tapping the underground stratum of a spring is appropriately
included in the definition of ``spring water'' in
Sec. 165.110(a)(2)(vi), as long as the source of the water is the same
no matter which method of collection is used, and the method of
collection does not interfere with the quality or composition of the
water.
39. Comments contended that this rulemaking is being orchestrated
by parties who will profit from being able to legally increase their
production of spring water by using pumping mechanisms. One comment
stated that the reason that anyone would bore a well next to a spring
is because the flow of water from the spring has decreased. Another
comment added that the bottled water industry wants a loophole that
would allow companies to call their well water by the better perceived
term ``spring water.''
One comment stated that to allow ``spring water'' to be collected
through a bore hole that is adjacent to the point of emergence is being
less than honest with consumers. This comment maintained that allowing
this practice only serves the interest of a special segment of the
bottled water industry. The comment stated that when bore holes have to
be qualified to determine whether they are adjacent to the spring and
to determine whether the water is from the same underground stratum,
and has all the same physical properties, composition, and quality, as
the water emerging at the surface, then fair dealing will be lost in
the many ways that these provisions will be interpreted.
Conversely, a comment that supported the use of a bore hole stated
that adoption of the standard as proposed would protect consumers
against artificial barriers to commerce and restraints on competition
that ultimately raise consumer prices and reduce product quality.
Another comment stated that the controversy about the use of a bore
hole stems partly from a lack of understanding of practices accepted
around the world and partly by small companies striving to use
regulations for competitive advantages.
One comment asserted that differentiating between the same water,
whether it comes from a natural orifice or from a bore hole tapping an
aquifer, is an artificial marketing difference.
Some comments stated that if the definition of ``spring water''
were to preclude the use of bore holes, many smaller companies would be
constrained from expanding their businesses. These comments added that
as long as the water is compositionally identical, the method of
extraction is a production matter and should not be a factor in
classifying the water.
The agency disagrees with the comment that stated that consumer
interests would be compromised by providing for the use of a bore hole
in the definition of spring water. As discussed in the response to
comment 35 in this document, many consumers have not formed opinions
concerning an appropriate method of extraction of spring water, and,
based on information from the consumer surveys and other comments
received, FDA has concluded that consumers are not misled because of
the use of a bore hole.
FDA also disagrees that its position only serves the interest of a
special segment of the bottled water industry. Currently, as stated by
many comments, over half of the spring water produced in the United
States is collected through bore holes. Not providing for the use of a
bore hole in the definition of spring water would thus force a
significant segment of the industry to relabel their products as other
types of bottled water products. Given that most consumers are not
concerned about whether a bore hole or a spring collection box is used,
and that FDA can control the source of the water and its composition
and quality by means of its standard, the agency advises that it is not
aware of any factor that compels such a result.
In addition, the agency disagrees that its definition will provide
a loophole to allow water that is not spring water to be called
``spring water,'' with certain parties profiting from a broadened
definition. FDA's definition is no broader than the definition used by
most States, most notably the major bottled water-producing States of
New York, California, Texas, and Florida. These States already provide
for the use of a bore hole, although the State of North Carolina has a
stricter definition for ``spring water.'' Many foreign governments have
even broader definitions for ``sp

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A95-27798. Public record. Not legal advice.