Beverages: Bottled Water

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 ``spring water'' than is provided by FDA's

definition. For example, the government of the province of Quebec

defines ``spring water'' as ground water containing greater than 10 ppm

TDS and less than 500 ppm TDS, regardless of whether the water flowed

to the surface of the earth or was collected through a well. Therefore,

FDA concludes that its definition will not create a loophole to

[[Page 57092]]

market water that is not spring water. FDA's definition is generally

consistent with worldwide industry practice and most government

regulations. Thus, if anything, FDA's definition will help to eliminate

artificial barriers to competition and commerce.

Although how the determination of whether a bore hole actually is

tapping a spring is made may vary because of regional geological

differences (e.g., limestone formations versus granite formations), the

water collected from a bore hole must be the same water that feeds the

spring's natural orifice. To be called ``spring water,'' the water must

be from a stream that flows naturally to the surface of the earth. No

matter what method of extraction is used, the water must have the same

physical properties, quality, and composition as the water that

actually flows to the surface.

The agency recognizes that there is the possibility of a bore hole

extracting water from an aquifer that does not feed the spring.

However, the agency is requiring in Sec. 165.110(a)(2)(vi) that the

water be from the same underground stratum, 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. Water from a

different underground stratum will have different properties and

characteristics. Thus, the water will not meet the definition of spring

water unless it has the same properties and characteristics as the

water that flows through the spring's natural orifice. Therefore,

Sec. 165.110(a)(2)(vi) will protect against the possibility of a bore

hole extracting water that does not feed the spring.

40. Comments noted that a domestically produced beer that is

identical to a German beer could not be called German beer because it

does not come from Germany. They stated that, similarly, spring water

must come from a spring, not a bore hole.

Another comment maintained that under the law, ``the public is

entitled to get what it chooses, though the choice may be dictated by

caprice or by fashion or perhaps by ignorance'' (F.T.C. v. Algoma

Lumber Co., 291 U.S. 67, 79 (1934)). It concluded that bottlers should

not be allowed to tell consumers that a product is spring water when it

actually comes from a bore hole.

The agency disagrees with the comments. In the example of the

German beer, FDA recognizes that a German source does indeed make the

product a German beer, and that if the beer was not produced in Germany

the product would not be German beer. However, in the case of spring

water, the underground source of the water, that is, the spring, will

be the same whether collected at the surface or through use of a bore

hole. It is only the method of extraction that is different. Therefore,

water that is from an underground formation from which water flows to

the surface, and that has the same physical properties, quality, and

composition as the water that flows to the surface, is fairly and

appropriately considered to be spring water even if it is extracted by

use of a bore hole.

41. Several comments stated that natural spring water is free

flowing, and that if a bore hole is used by a bottler, it should be so

noted on the label to allow consumers to make the ultimate decision on

this issue.

Other comments suggested that to differentiate between spring water

that is naturally flowing and spring water that is collected from a

bore hole, FDA should define ``natural spring water'' as water that is

derived from an underground formation from which water flows naturally

to the surface of the earth and ``spring water'' as water derived from

an underground source from which water flows naturally or through a

bore hole adjacent to the point of emergence. One comment added that to

not differentiate between ``natural spring'' and ``spring'' waters

would be to perpetuate a fraud.

The agency disagrees with the comments. As defined in

Sec. 165.110(a)(2)(vi), the underground source of ``spring water'' must

be the same whether it is extracted from the natural orifice or from a

bore hole. In addition, as shown by the submitted surveys, many

consumers did not object to the use of a bore hole to extract spring

water. Therefore, it is not necessary to establish mandatory labeling

regulations to distinguish between spring water extracted through a

bore hole or through the natural orifice. However, FDA would not object

to a truthful, nonmisleading statement on the label that stated that

the water flowed naturally to the surface, if indeed the water was

extracted from the natural orifice without the use of external force,

or to a statement that the water was extracted through a bore hole.

42. One comment suggested that bore hole-collected water more

clearly fits the definition of ``artesian well water.'' It stated that

FDA defined the other types of water with their proper historic

geologic definitions, and that spring water should also be defined in

this manner.

The agency disagrees that spring water collected from a bore hole

more clearly meets the definition of ``artesian water.'' The definition

for ``spring water'' mandates that the water come from an underground

source where water flows naturally to the earth's surface before the

drilling of a bore hole. Artesian water comes from a well tapping a

confined aquifer. Artesian water does not flow to the earth's surface

unless a well is drilled to tap the source, and the natural hydraulic

pressure is great enough to force the water to the earth's surface.

Therefore, spring water and artesian water are from distinct sources.

However, to clearly distinguish between the definitions of ``artesian

water'' and ``spring water,'' FDA is modifying Sec. 165.110(a)(2)(vi)

to state that there must be a natural force causing the water to flow

to the surface through a natural orifice for the water to be labeled as

``spring water.''

c. Adjacency

43. Some comments asked how one could be assured that water

collected through a bore hole would have emerged from the ground

through a free-flowing spring at a point adjacent to the bore hole had

it not been extracted through the bore hole.

Several comments suggested that FDA incorporate a requirement for

hydrogeological data to demonstrate a hydraulic link between a bore

hole and a spring to document that the source is a spring. One comment

added that the spring water definition will not resolve the matter of

whether a bore hole is adjacent to a spring unless scientific support

for the term ``adjacent'' is presented.

Some comments suggested specific methods to determine the hydraulic

linkage. These included using dye tracer tests, geophysical

conductivity tests, water analyses, and graphical methods, such as the

Stiff diagram and the Piper trilinear diagram, to demonstrate that the

chemical and physical characteristics of the water correspond to those

of the spring. Comments stated that pumping should cause a measurable

decline in the spring's discharge rate if the well is tapping spring

water, although if the withdrawal rate from the bore hole is small

relative to the discharge rate of the spring, or if the spring is

submerged, this decline may not be measurable.

The comments stated that because of the differences in the mineral

composition of geological strata, no one set of analyses will apply to

all spring formations to demonstrate compliance with these criteria.

Some comments suggested that the criterion of adjacency used in the

hydrogeological context of hydraulic connection is reasonable and

logical and objectively addresses this important and

[[Page 57093]]

controversial issue. They requested that language be added to the

regulation to require that bore hole adjacency to the spring be

verified by its measurable hydraulic influence on the spring flow from

the natural orifice at the time of collection, as certified by a

professional hydrogeologist.

However, some comments asserted that it will be difficult to

establish the uniformity or sameness of actual spring water and water

collected through an adjacent bore hole.

The agency agrees that hydraulic linkage is important in the

definition of ``spring water.'' If the bore hole taps the same

underground water source as that which feeds the natural spring, and

has the same physical properties, composition, and quality as the water

emerging from the natural orifice, it is clear that the location of the

bore hole relative to that of the point of emergence is not relevant.

However, a bore hole adjacent to a natural emergence can actually tap

another water bed far below the aquifer feeding the natural spring

source and thus collect water of a totally different composition from

that of the water which emerges from the natural spring.

The agency concludes that requiring a hydraulic (i.e., physical)

connection between a bore hole and a spring will clarify the definition

of spring water and will eliminate the possibility of indiscriminate

bore hole use. Therefore, FDA is modifying its definition of ``spring

water'' in Sec. 165.110(a)(2)(vi) to require that a measurable

hydraulic connection, using a hydrogeologically valid method, between

the bore hole and the natural spring be established to show that the

water is from the same underground stratum as the spring.

The comments suggested several different methods to determine

hydraulic linkage. One or more hydrogeologically valid methods may be

used as appropriate to determine hydraulic linkage. However, not all

methods may be appropriate for different geologic regions or for the

specific bore hole site. Therefore, the agency is not recommending or

requiring any specific method or methods.

44. Some comments stated that the location of the bore hole

relative to that of the point of emergence is not relevant as long as

the bore hole taps the same underground water source as that that

feeds, or that would feed, the natural spring if not for the collection

below the earth's surface. Other comments objected to the use of the

word ``adjacent'' in the definition because they believe that it is

ambiguous. Comments suggested that the agency modify the definition for

``spring water'' to delete the use of the term ``adjacent.'' One

comment added that such a definition would be easier to enforce and

would eliminate the need to arbitrarily decide what ``adjacent'' means

in terms of a measurable distance.

Conversely, one comment stated that if bore hole access is

permitted in the final definition of ``spring water,'' then it is

crucial to retain the requirement that the bore hole be adjacent or

near to the point of natural emergence of the spring. The comment

stated that this requirement is necessary to assure that the bore hole

is tapping only water that would otherwise emerge at that point, and

that consumers are not misled that they are purchasing spring water

from a specifically identified spring source.

The agency agrees with the comments that suggested that the term

``adjacent'' be deleted from the definition of spring water. As

discussed in the previous comment, the agency is requiring that there

be a measurable hydraulic connection, using a hydrogeologically valid

method, between the bore hole and the natural spring established to

show that the water is from the same underground stratum as the spring.

To meet the definition of ``spring water,'' the manufacturer must

ensure that the water collected through a bore hole is from the same

underground stratum as the spring and has the same physical properties,

composition, and quality as the water that flows naturally to the

surface of the earth from the spring. Water collected at a distance

from the natural orifice will not have traveled the same path as the

water that flows from the natural orifice of the spring and, therefore,

could have a different composition. FDA is accommodating the use of

bore hole technology so long as there is assurance that the water from

the bore hole has the same composition and characteristics as the water

from the natural orifice. If the bore hole is too far from the natural

orifice, the latter assurance would not exist.

FDA concludes that the requirement of a measurable hydraulic

connection between the bore hole and the spring's natural orifice

adequately encompasses the intent of the proposed adjacency

requirement. Therefore, the agency is deleting the requirement in

Sec. 165.110(a)(2)(vi) that the bore hole be adjacent to the point of

emergence of a spring.

45. A number of comments asked FDA to explain or define the terms

``adjacent'' and ``point of emergence.'' Comments requested that FDA

designate a specific distance (e.g., 50 feet, 100 feet, 250 feet, 1

mile) for how far bore holes could be located from the source and still

meet the criterion of ``adjacent to the point of emergence.'' One

comment suggested that a person should be able to see the spring and

bore hole at the same time. Some comments held that the rule should

specify that the bore hole must be as close as possible to a

specifically identified spring discharge, and that the bore hole must

be closer to the spring discharge than to any other source of ground or

surface water.

One comment stated that the State of California informally defines

``adjacent'' as a distance of approximately 250 feet. It stated that

this definition avoids cases of confusion, such as the installation of

spring bore holes several miles from the spring location. Other

comments stated that some States have used a ballpark figure of 200

feet for adjacent, others more or less than 200 feet.

Another comment stated that the reasoning provided in the preamble

of the proposal necessitates a relatively narrow interpretation of

``adjacent'' as a point located a minimal distance from the spring

orifice and asked that a statement to this effect be included in the

regulation.

In the preamble of the January 1993 proposal (58 FR 393 at 399),

FDA stated that allowing for a bore hole adjacent to a spring would

provide for the tapping of the source at a point near the mouth of the

spring. The agency is not specifying a particular distance between a

bore hole and the mouth of the spring because the appropriate distance

will vary significantly in different geological areas. FDA is also not

adopting a requirement that a person be able to see the spring and bore

hole at the same time because, depending on the terrain, a person may

be able to see a great distance or only a small distance. Therefore,

FDA finds that defining ``adjacent'' in these terms would not be

appropriate. As discussed in the previous comment, the agency is

defining adjacency in terms of a measurable hydraulic connection.

FDA agrees that the collection apparatus should be as close as

possible to the specifically identified spring discharge. The agency

also agrees that the bore hole should normally be closer to the spring

discharge than to any other source of ground or surface water. However,

the agency does not agree that this distance need be specified in the

regulation because it is requiring that a measurable hydraulic

connection, using a hydrogeologically valid method, between the bore

hole and the natural spring be established to show that the water is

from the same underground stratum as the spring

(Sec. 165.110(a)(2)(vi)). The agency

[[Page 57094]]

concludes that the requirement for a hydraulic connection is

appropriate and avoids uncertainty concerning any specific distance

implied by the term ``adjacent.''

46. Comments requested that FDA address the issues of ownership and

control in the regulations. Comments questioned whether proper

inspections could be mandated in a case where a spring is located on

one owner's property, and the bore hole is on another's property. One

comment stated that the ownership and control of the bore hole should

be the same as that of the spring for quality control purposes. One

comment stated that, if a company owns, or owns the rights to, a

legitimate spring, it should not matter how it collects the water as

long as it does so in a sanitary way.

The issues raised by these comments are outside the scope of this

rulemaking and really beyond the coverage of the act. Issues of

ownership and control turn on property laws, water rights, and access

to the spring's natural orifice. However, FDA cautions that a

manufacturer must be able to test the water that flows naturally to the

surface of the earth to ensure that the water that it is collecting

from the bore hole is the same water as that from the spring that flows

to the surface, and that there is a hydraulic connection between the

bore hole and the natural spring. If the manufacturer cannot establish

that the water that it is calling ``spring water'' is the same as that

from the identified spring, it runs a significant risk that its product

is misbranded, and, thus, that it will be the subject of a regulatory

action.

d. External Force

47. Several comments objected to the use of external force in the

collection of spring water. One of the comments stated that consumers

believe that spring water has no unique taste, color, or other

characteristic other than being water that comes to the surface through

a natural orifice, and that most believe that the water flowed to the

surface by the spring's natural pressure. Comments stated that to

furnish other than a natural flow rate by supplemental pressure is

misleading, and that such a product should be labeled as ``well

water.''

Comments stated that the use of a bore hole is appropriate only if

external force is not used. One comment stated that the freely flowing

water from a natural spring site represents the overflow of the

underlying aquifer, and that, by contrast, pumped water from a vertical

well of arbitrary depth may tap many hydrogeologic layers, drawing

against the storage of the aquifer. The comment asserted that some

trace of the natural flow should be visible at the original spring

orifice.

One comment stated that some of the problems associated with pumped

wells are: (1) The cone of depression caused by pumping an unconfined

aquifer triggers a series of changes in the ground water and aquifer;

(2) dewatering the aquifer around a well allows air intrusion into the

formation voids, which can oxidize iron and other metals resulting in

reduced water storage capacity, thereby increasing the size of the cone

of depression; (3) pumping from an aquifer that yields water to a

spring can induce recharge from neighboring hydrogeologic units that

are not normally hydraulically connected to the spring; and (4) pumping

an aquifer causes changes in flow velocity and direction of flow and

creates turbulence.

The agency does not agree that the use of external force should be

prohibited for the extraction of spring water. Although there must be a

natural force that causes at least some of the water to flow to the

surface through a natural orifice, this force may not be sufficient to

cause the water to flow through some bore holes. The angle and the

distance of the bore hole from the mouth of the spring may not provide

adequate water pressure for the water to flow through the bore hole.

It is true, as described by the comment, that changes may occur in

the underground strata as a result of pumping. The creation of a cone

of depression, changes in water flow, and the nature of the recharge

can alter the composition of the ground water. However, if the

properties of the water change as a result of the use of external

force, the water is no longer spring water because the water is no

longer the same water that flows through the natural spring orifice. If

pumping action alters the properties of the water, pumping will have to

cease, and the area allowed to return to its natural equilibrium, so

that water collected from the bore hole with the aid of external force

will once again have the same properties as the water flowing from the

natural spring orifice. If not, while pumping may continue, the water

can no longer be labeled as ``spring water.''

Finally, the agency points out, in response to one comment, that if

water is pumped from a vertical bore hole of any depth that taps other

hydrologic strata, that water is not spring water.

FDA concludes that the use of external force in the collection of

spring water is not misleading to consumers because the agency is

requiring in Sec. 165.110(a)(2)(vi) that the water be derived from an

underground formation from which water flows naturally to the surface

of the earth; that the water have the same physical properties,

composition, and quality as the water that emerges from the natural

orifice; and that there be a hydraulic connection between the bore hole

and the spring stratum. Thus, the agency concludes that the definition

will ensure that water labeled as ``spring water'' meets consumers'

expectations.

48. Three comments stated that FDA should require that the spring

continue to flow to the surface naturally. They stated that if the

spring ceases to flow for a period of 90 days, then the water from the

bore hole should no longer be considered to be spring water, and any

labeling of the product as such must cease. One of the comments stated

that such a requirement would help to ensure the integrity of the

spring source and prevent contamination caused by a reversed flow close

to the ground surface.

One comment stated that if the spring ceases to flow to the earth's

surface, the pumping mechanism is at fault, and comparative samples

would not be available. Another comment asked whether, if the spring

ceases to flow as a result of pumping, the water may still be called

``spring water.''

The agency agrees with the concerns of the comments. In some cases

pumping may cause the spring to cease flowing through the natural

orifice, and, thus, comparative samples of the water would not be

available because of the use of external force when the water is

collected through a bore hole. It is important to maintain some flow of

water through the natural orifice to prevent any reverse flow of

surface water, which could then be pumped through the bore hole. As

previously stated in the response to comment 12 of this document,

ground water under the influence of surface water cannot be called

``spring water.''

FDA recognizes that occasionally a spring may cease flowing

temporarily because of fluctuations in ground water levels. Ground

water fluctuations may be caused by natural conditions (e.g., drought)

or man-induced (e.g., pumping) and are classified as short-lived,

diurnal, seasonal, and long-term changes (Ref. 9). If the spring has

ceased flowing, and this cessation is not a temporary condition, the

water is not spring water. In addition, if the external force is

routinely (e.g., more often than during the time of year when the water

table is typically low) causing cessation of the spring's flow to the

surface, this too is not a temporary condition, and

[[Page 57095]]

the water does not qualify to be called ``spring water.''

The State of Florida's definition for ``spring water'' does not

include water from a strata feeding a spring that ceases to flow

naturally to the surface for a period of 90 days (Comment 184). The

agency agrees that there must be an expectation that the spring will

continue to naturally flow to the surface for the water to qualify as

spring water. Thus, any cessation in the flow of the spring from the

natural orifice must be for a limited period of time. Ninety days is an

appropriate time limit for seasonal types of changes in ground water.

However, the agency will consider each situation on a case-by-case

basis and take into consideration all circumstances (e.g., climatic

conditions and effect of pumping) causing the flow cessation.

To clarify in Sec. 165.110(a)(2)(vi) that the spring must continue

to flow when external force is applied to a bore hole in the collection

of spring water, FDA is deleting the statement that it included in the

proposed regulation that the water would flow naturally to the surface

of the earth if not for its collection below the earth's surface. In

addition, the agency is adding a requirement in Sec. 165.110(a)(2)(vi)

that if spring water is collected with the use of external force, water

must continue to naturally flow to the surface of the earth through the

spring's natural orifice.

49. A number of comments expressed concern that the use of external

force will allow a spring water bottler to extract more water from the

ground than would have naturally flowed to the surface of the earth

through the spring's natural orifice. Comments requested that the

agency include a provision in the definition of ``spring water'' to

require that the quantity of water extracted through external force not

exceed the quantity of the water that would flow naturally to the

surface of the earth if not for its collection below the earth's

surface.

Two comments asked what the purpose of permitting the use of a bore

hole was if the quality of the water from the bore hole must equal that

of the water that flows naturally to the earth's surface except to

enable the pumping of larger volumes of water from a stratum. Another

comment held that under the proposed rule, there will be few springs

developed with collection boxes because bore holes will be generally

more economically advantageous, and greater volumes of water will

normally be available through the use of bore holes than through the

use of collection boxes.

One comment added that provision for the use of bore holes could

encourage bottlers to exceed the safe yield from the spring's aquifer.

It stated that excessive withdrawal is usually discussed in terms of

``mining'' of the water (defined as when more water is withdrawn than

is replaced by recharge). The comment stated that the real issue as far

as surface contamination is concerned is not the ``mining'' of water or

the collection device but the quality and purity of the aquifer as

determined by the source of recharge.

One comment expressed concern that the proposed rule is silent on

any method to identify when, because of overpumping, wells are

capturing water that would otherwise not flow to the spring. It stated

that overpumped bore holes (i.e., those that pump more water than the

spring naturally discharges) could induce flow from surface water or

nearby contaminant sources, such as septic tanks. The comment stated

that possible solutions to this problem would be to: (1) Restrict the

allowable daily pumping volume to that volume equal to the natural

average (mean) daily flow from the spring; (2) restrict the use of bore

holes to those that do not require the ``assistance of external force''

(i.e., pumping); or (3) require a demonstration that any additional

pumping is not altering the flow paths to the spring such that flow is

induced from nearby potential sources of contamination to the well.

FDA agrees that there may be adverse effects of overpumping (i.e.,

mining) a bore hole that is tapping a spring. There may be public

health concerns if the recharge to the aquifer is contaminated by

surface water. In addition, ground water extracted with external force,

and under the direct influence of surface water because of overpumping,

is not spring water because the source of the water is not entirely the

source that feeds the spring. However, such water may be treated and

called ``bottled water'' or another applicable name.

FDA does not object to the use of external force, and does not deem

it necessary to restrict the amount of water that may be extracted

through the use of external force, as long as the water meets the

requirements of Sec. 165.110(a)(2)(vi) (e.g., it is compositionally the

same as the water flowing from the natural orifice). Water that has not

traveled the same course as the water feeding the spring, and, thus,

that does not have the same characteristics as water from the spring,

cannot be labeled as ``spring water.''

The agency disagrees that allowing the use of a bore hole and

external force will decrease the number of springs developed with

collection boxes. Many States already allow the use of both extraction

methods, and both methods are already used by manufacturers. Providing

for the use of both methods of collection of spring water allows

manufacturers the flexibility to use the method best suited for their

spring site.

A demonstration that pumping is altering the flow paths to the

spring, such that flow is induced from nearby potential sources of

contamination to the bore hole, could include bore hole pump tests,

monitoring of observation wells, and ground water flow modeling. EPA's

Ground Water Protection Division has developed a variety of tools

designed to assist State and local governments in the task of

identifying the capture zones of pumping as part of the Wellhead

Protection Program (WHPA). A capture zone is the area around a bore

hole containing ground water that is destined to flow to that bore hole

within a specified time. EPA's existing ground water flow model (WHPA

2.1) can identify induced flow from surface water caused by changes in

pumping rates. Should a demonstration of the effects of pumping be

required, this model could be used as a tool by government agencies to

determine the impact of the aquifer's recharge. FDA concludes that a

ground water flow model could be used to ascertain whether allowable

overpumping is inducing deleterious results. However, regardless of the

use of external force to extract spring water, the water must still

comply with the definition in Sec. 165.110(a)(2)(vi) to be labeled as

``spring water.''

e. Source Approval and Enforcement Issues

50. Comments asked how it can be proven that the water from the

bore hole is from the same stratum as the water that is actually

emerging from the spring. They stated that once the bore hole at the

spring has been constructed and the establishment is in operation, it

would be difficult to verify that the water from the bore hole met the

definition of spring water. One comment asked what type of

documentation the producer could keep that would satisfy the

requirements of the regulation concerning source. It asked whether the

records or a certification statement from the drilling company that

drilled the holes would be necessary, or whether a site examination and

the manufacturer's word on source would be adequate.

One comment expressed concern about potential abuse from the use of

a bore hole because the nonexistence of a

[[Page 57096]]

spring can be readily attributed to the effect of the bore hole, and no

confirmation of the prior existence of a spring at that location is

required.

The agency acknowledges the concerns of the comments. Section

129.35(a)(1) states that the product water supply for each plant shall

be: (1) From an approved source that is properly located, protected,

and operated; (2) easily accessible, adequate, and of a safe, sanitary

quality; and (3) in conformance at all times with the applicable laws

and regulations of the government agency or agencies having

jurisdiction. However, part 129 does not require that the government

agency having jurisdiction identify or certify that the source is a

spring source.

As discussed in the response to comment 48, FDA has modified

Sec. 165.110(a)(2)(vi) to mandate that the spring continue to flow,

although it may be at a diminished rate, for the product to qualify as

``spring water.'' In addition, it is important that manufacturers

identify the location of the spring to determine that the water is, in

fact, flowing and, thus is spring water. A spring is a flow of water

from the earth. If there is no identifiable spring, the water can not

be labeled as ``spring water.'' Thus, it is critical that manufacturers

of ``spring water'' identify the exact location of the natural orifice

where the spring flows from the earth. Therefore, the agency is

modifying Sec. 165.110(a)(2)(vi) to include a requirement that the

location of the spring be identified.

There must be other means of verifying labeling claims once the

bore hole at the spring has been constructed, and the establishment is

in operation. As discussed above under ``1. Artesian Water,'' the

agency may promulgate regulations for the efficient enforcement of the

Act under section 701(a) of the Act. Although it is possible to

determine that a source of water is a spring after the bore hole is in

operation, in some cases it would be onerous for regulatory officials

to do so. Therefore, FDA has determined that a requirement to

demonstrate the hydraulic connection between the bore hole and the

spring's natural orifice is necessary for the efficient enforcement of

the Act.

As FDA has stated, 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

consumers'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.2d 189, 193

(D.C. Cir. 1986), cert. denied, 479 U.S. 1086 (1987). Thus, making a

claim without such a basis would be misleading and in violation of

section 403(a) of the Act.

The evidence that manufacturers compile in response to the

requirement in Sec. 165.110(a)(2)(vi) that they be able to demonstrate

to regulatory officials that a measurable hydraulic connection exists

between the bore hole and the natural spring orifice (see comment 43 of

this document) should also establish that the spring is the source of

water for the bore hole. To comply with this requirement, producers may

maintain records that demonstrate that a measurable hydraulic

connection does indeed exist between the natural orifice and the bore

hole. In addition, many States and the United States Geological Survey

may have records of the development of some springs and the geology of

the surrounding area. Records or a certification statement from a

professional hydrogeologist or the drilling company that drilled the

holes are appropriate sources of documentation. In addition,

manufacturers may use methods such as the dye tracer test to

demonstrate the hydraulic connection during an inspection.

If the source does not meet the definition of spring water then the

product must not be labeled as ``spring water,'' or it is misbranded

under sections 403(a), 403(b), and 403(g) of the Act. 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 and be able to provide FDA with this information

upon request.

51. Several comments expressed concern about the requirements that

spring water be ``from the same underground stratum,'' ``retain all the

physical properties,'' and ``be of the same composition and quality.''

They stated that these requirements are too general and are undefined,

leaving many questions relative to acceptable differences in such

parameters as temperature, pH, turbidity, hardness, iron content, and

calcium content. One comment stated that it will be difficult for FDA

or any other government agency to monitor the conditions required for

``spring water.''

One comment requested clarification of the requirement in part 129

that product and source waters be approved by State regulatory agencies

having approval authority. It asked whether the proposed regulations

mandated approval of the bore hole and the spring, whether the spring

must be validated as a natural spring, and whether engineering had to

be performed to protect the spring site if a bore hole is to be

utilized. The comment stated that there is no reference to continuous

maintenance of the spring. Comments asked how many, and at what

frequency, tests are necessary to show that water from the bore hole is

identical to water from the spring.

Comments stated that manufacturers should present geological

information about the vicinity of the orifice and bore hole so that the

State can devise a representative set of water quality analyses

specific to the situation.

FDA notes that the source is approved by the government agency or

agencies having jurisdiction (Sec. 129.3(a)), and that in many cases,

it will be a State agency. However, the approval mandated under part

129 is to inspect the source and sample the water to ascertain that the

water is of a safe and sanitary quality. Firms are responsible for

ensuring that their products comply with the particular source

requirements in Sec. 165.110(a)(2)(vi). As discussed previously, the

bottled water firm must be able to demonstrate to regulatory officials

that a measurable hydraulic connection exists between the bore hole and

the natural spring, and that the water complies in all other respects

with Sec. 165.110(a)(2)(vi).

Concerning continuous maintenance of the spring, the firm is

responsible for ensuring that their products comply with all applicable

regulations. The quality of the source water is critical to the quality

of the final product. Without proper maintenance of the spring, the

quality of the source water will decrease, and the firm is taking a

risk that the water will not meet FDA requirements. Thus it is in the

interest of the firm to maintain the source in appropriate condition.

In regards to methods of testing for comparative purposes, one or

more hydrogeologically valid methods may be used as appropriate to

verify that the product is in compliance. However, not all methods may

be suitable for different geologic regions or for the specific bore

hole site. Therefore, the agency is not recommending or requiring any

specific method or methods.

Under Sec. 165.110(a)(2)(vi), manufacturers must be able to

demonstrate, upon request, to regulatory officials that there is a

measurable hydraulic connection between the natural spring and the bore

hole. This verification must be current to be satisfactory. It is the

responsibility of the firm to be in compliance at all times.

[[Page 57097]]

52. Two comments asked for clarification of whether water emerging

at the surface not as a result of flow from an underground formation or

aquifer, but as the result of seepage from a higher elevation surface

water source reemerging at a lower elevation, is really spring water

(e.g., springs fed by higher level lakes; underground creeks popping up

to the surface; or other surface water that originates high in a

mountain which emerges at a lower elevation).

The agency considers that surface water from a higher elevati

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