[Federal Register Volume 60, Number 218 (Monday, November 13, 1995)]
[Rules and Regulations]
[Pages 57076-57130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27798]




[[Page 57075]]

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Part III





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Part 103 et al.



Beverages: Bottled Water; Final Rule

  Federal Register / Vol. 60, No. 218 / Monday, November 13, 1995 / 
Rules and Regulations   

[[Page 57076]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 103, 129, 165, and 184

[Docket No. 88P-0030]
RIN 0910-AA11


Beverages: Bottled Water

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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'' <71> 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 elevation 
reemerging through a natural orifice at a lower elevation is spring 
water if the water has traveled sufficiently through the ground so as 
not to be under the direct influence of surface water. According to 40 
CFR 141.2, ground water under the direct influence of surface water 
means 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. The existence of any of these factors 
indicates that the source is under the direct influence of surface 
water and is, therefore, not a ground water source that meets the 
definition of ``spring water.''
    A spring is water from an underground source that flows naturally 
to the surface of the earth. Under normal conditions, aquifers feeding 
springs are in a stable environment. On the other hand, surface water 
is subject to a changing environment and may assimilate these changes. 
Thus, if water flowing naturally to the surface of the earth exhibits 
the characteristics of surface water, it does not comply with the 
definition of ``spring water'' in Sec. 165.110(a)(2)(vi) and is not 
spring water.
    53. One comment claimed that some members of industry consider any 
wet location on an otherwise dry mountainside or flat pasture to be a 
spring. The comment stated that sometimes these wet spots can bead 
water, producing a small trickle. The comment contended that after 
development, these wet spots can sometimes produce a considerable flow 
of water. It also stated that water has been known to come up in 
natural depressions in hillsides without flowing until the water is 
pumped. The comment requested clarification on these questions. It 
asked whether any alteration to the natural terrain that results in 
water coming spontaneously to the surface of the alteration should be 
deemed a spring (e.g., a road cut into a mountain and in this cut water 
trickles (or gushes) out).
    FDA is defining ``spring water'' in Sec. 165.110(a)(2)(vi) as water 
derived from an underground formation from which water flows naturally 
to the surface of the earth. There must be a natural force causing the 
water to flow to the surface through a natural orifice. If the water 
does not flow to the surface of the earth from the underground source 
without development of the area or the use of external force, then the 
water does not qualify for use of the name ``spring water.''
    54. One comment complained that the January 5, 1993 proposal, if 
adopted, would be yet another Federal mandate, without Federal funding, 
to State agencies having the responsibility of ensuring compliance. It 
stated that justification for additional program expenditures must be 
based on need and public safety. The comment stated that there has been 
no evidence presented that adoption of the proposed rules would 
increase product safety.
    One comment stated that the very general nature of FDA's proposal 
would create problems for regulatory agencies attempting to implement 
and enforce the rule by generating additional workload, controversy 
within the bottled water industry, and legal battles over whether a 
``bore hole'' is tapping ``spring water'' or ``well water.''
    Comments stated that the use of a bore hole in the collection of 
spring water would make enforcement of the provision not only expensive 
but most difficult.
    The agency disagrees that it is imposing a burden on State 
regulatory agencies by establishing a standard of identity for spring 
water. There is no requirement that a State ensure that a firm is 
complying with FDA regulations. However, a State may elect to enforce 
Sec. 165.110 under section 310(b) of the Act (21 U.S.C. 337).
    In response to comments, the agency has added provisions to its 
definition of spring water that make it more specific and that should 
make its requirements more understandable both to the regulated and the 
regulators. Manufacturers must identify the location of the spring; 
there must be evidence that the water is flowing naturally to the 
surface through a natural orifice; firms must demonstrate and be able 
to verify to regulatory officials that there is a measurable hydraulic 
connection between the bore hole and the natural spring; and water must 
continue to flow naturally to the surface of the earth through the 
springs' natural orifice. FDA concludes that these provisions will aid 
in enforcement of the definition of ``spring water.''
f. Contamination and Sanitary Bottling
    55. A number of comments disagreed with FDA's statement in the 
preamble to the proposal that use of a bore hole will reduce the 
possibility of contamination and is an aid in the sanitary bottling of 
spring water (58 FR 393 at 399). Two comments argued that the available 
evidence did not support that a bore hole is a more sanitary method to 
collect spring water than a collection box. Comments stated that a 
properly engineered and constructed spring collection box system can 
adequately protect a natural spring from outside microbial 
contamination.
    A comment stated that if the quality of spring water is an issue, 
then it can and should be addressed by quality standards rather than by 
altering the common definition of spring water to permit use of a bore 
hole. It argued that the evidence of record on this rule does not 
justify any departure from the accepted definitions of ``spring'' and 
``spring water.'' Another comment stated that with respect to bore 
holes serving as an aid in the sanitary bottling of the water, FDA 
already has provisions for this purpose in part 129. It stated that 
bore holes as aids in sanitary bottling of water should not be a 
consideration under the standard of identity.
    Another comment stated that the proposed rule provides no 
specifications for the construction of bore holes, and that, if 
improperly constructed, sources of contamination could enter the 
aquifer through the bore hole. It stated that the technology exists to 
protect a spring water source at its point of discharge, and that 
treatment systems can be incorporated at the point of discharge to 
provide protection from a number of types of potential contaminants.
    The agency points out that both properly engineered and constructed 
bore holes and properly engineered and constructed spring collection 
boxes are appropriate methods to collect spring water. However, in some 
circumstances, use of a bore hole instead of a collection box will 
reduce the possibility of contamination and thus aid in the sanitary 
bottling of the water. For example, springs may surface in areas where 
it would be difficult to collect the water at the orifice without 
contaminating the water. In such cases, use of a bore hole can be an 
effective means to extract the water in a sanitary manner. In all cases 
the processing and 

[[Page 57098]]
bottling of drinking water must comply with part 129.
    FDA agrees with the comments that stated that sanitation is a 
function of GMP and not a standard of identity. The agency stated in 
the preamble of the proposed rule that the use of a bore hole would 
reduce the possibility of contamination and would be an aid in the 
sanitary bottling of the water (58 FR 393 at 399), but the intent of 
this statement was not to say that use of a bore hole is a superior 
method of collecting the water. Rather, the agency was saying that even 
though the geological definition of ``spring water'' does not provide 
for bore holes, it is a good idea to include their use in the 
definition of ``spring water'' because it would provide an alternative 
sanitary means of extracting the water. Thus, the statement was 
intended to be a basis for what the agency was proposing to do, not to 
be an end in itself. The usefulness of bore holes is one of several 
factors that have convinced the agency that it is appropriate to 
include water collected by means of their use in the definition of 
``spring water.''
    External force is often used with bore holes to extract the water. 
To clarify the agency's intent that use of bore holes, including those 
using external force, or properly engineered and constructed spring 
collection box systems must adequately protect the water, FDA is 
modifying Sec. 165.110(a)(2)(vi) to remove any inference that 
manufacturers may use external force to protect the water. Under part 
129, any method of collection of spring water must protect the water 
(Sec. 129.35(a)(1)).
    The agency is not providing detailed specifications for the 
construction of bore holes or for the construction of spring collection 
boxes. Appropriate construction specifications may vary according to 
the site. However, construction of either type of collection mechanism 
must be in accordance with current good engineering practice. In 
addition, under Sec. 129.3(a), the source water must be of a safe and 
sanitary quality. Proper construction will greatly assist in complying 
with this requirement.
    56. Comments asserted that a main concern is that drilling a bore 
hole next to a free flowing spring orifice may create a hydraulic 
connection or direct communication between any nearby surface water 
(river, creek, lake, pond, or swamp) and the spring source and, thus 
serve only to increase the risk of contamination. Comments were 
concerned about altering the patterns of recharge by the use of 
external force and lowering the quality of the water as a result. One 
comment stated that the use of bore hole collection systems runs 
contrary to the standards set by EPA regulations (40 CFR part 141) 
because, almost by definition, the bore hole will be shallow, and it 
can be sited near surface waters created by the discharging spring.
    Conversely, one comment stated that, in a properly equipped bore 
hole, reverse ground water flow from the surface should not occur. It 
stated that pumping may change the flow of ground water in a horizontal 
direction within the aquifer, specifically within the cone of 
depression created by pumping, and that if a bore hole is properly 
equipped and managed, vertical movement of surface water downward into 
the screen will not occur. It added that properly equipped bore holes 
are accepted by both Federal and State agencies as safe supplies of 
both domestic and municipal drinking water.
    FDA agrees that the potential exists for improper recharge of an 
aquifer feeding a spring. Water recharge is an issue that must be 
considered during source approval because there is the potential that 
the recharge may come from surface sources that may contaminate the 
underground source. For source approval, the government agency having 
jurisdiction must determine whether the water will be of a safe and 
sanitary quality. The States, however, have experience with issues of 
this type.
    The establishment of a definition for ``spring water'' does not 
have any effect on the State's burden in reviewing a site for approval, 
whether a bore hole or a collection box is to be used. The State's 
decision on whether to approve a source has nothing to do with how 
water collected from that source and bottled is to be labeled. That 
decision is made by the bottler, subject to the definitions in 
Sec. 165.110(a)(2)(vi) and the scrutiny of FDA.
    57. One comment stated that the language of the proposed rule 
creates the impression that spring water may be collected from the 
surface, which is unlikely, and that bottlers may bottle untreated 
surface water. The comment stated that surface water intended for 
drinking must undergo treatment that may result in alteration of the 
original chemical properties of the water, which would destroy the 
product's identity as ``spring water'' in the public's perception. It 
recommended that the following language be added to the definition of 
spring water: ``After treatment, spring water shall maintain the same 
physical properties and chemical composition as the water that does or 
would flow naturally to the surface of the earth.''
    FDA disagrees with the comment. Spring water may be collected from 
the surface by means of a collection box. A properly engineered 
collection box captures the water as it surfaces, before it can be 
contaminated by surface elements and become surface water. However, 
spring water collected under the most sanitary conditions may still 
require some treatment.
    The definition of ``spring water'' is based on the underground 
source of the water. Thus, water meeting the definition of ``spring 
water'' in Sec. 165.110(a)(2)(vi) would remain spring water after 
treatment, even if the physical properties and chemical composition of 
the water are altered from such treatment. For example, ozonation is 
commonly used to treat bottled water and may cause some dissolved 
minerals, such as manganese, to precipitate. Other treatments, such as 
filtering, may also cause changes in the water. As long as the water 
meets the definition of ``spring water,'' however, even though it has 
been treated, it may be called ``spring water.''
    In the case of spring water extracted from a bore hole, the water 
must be compared with the water extracted from the natural spring. When 
that comparison occurs, either before or after any treatment, may have 
a significant impact on whether the water collected from the bore hole 
maintains the same physical properties and chemical composition as the 
water from the natural orifice. To clarify the intent of the 
regulation, FDA is modifying Sec. 165.110(a)(2)(vi) to state that, 
before treatment, the water collected from the bore hole must have the 
same physical properties and chemical composition and quality as water 
from the natural spring.
    However under section 201(n) of the Act, if the water has been 
treated in such a way that it differs significantly from the source 
water, regardless of whether that source water is from a natural spring 
or a bore hole, the fact that that alteration has been made is a fact 
material in light of representations made and must appear on the label 
of the product. The water is no longer unmodified spring water and 
differs significantly from the water that was harvested. Therefore, the 
fact that the water has been altered significantly must be disclosed 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), 

[[Page 57099]]
that fact must be included in the statement of identity of the product 
as well (e.g., demineralized) (Sec. 165.110(a)(2)(iv)).
5. Well Water
    FDA proposed that the name of bottled water from a hole bored, 
drilled, or otherwise constructed in the ground that taps the water of 
an aquifer may be ``well water.'' The agency received no comments 
requesting modifications to this source definition. Therefore, the 
definition for ``well water'' is the same as FDA proposed (58 FR 393), 
although it is now codified at Sec. 165.110(a)(2)(viii) as a result of 
the additions that FDA has made to Sec. 165.110(a)(2).
6. Other Water Definitions
    58. Several comments urged FDA to define ``natural water.'' 
Comments suggested that ``natural water'' means bottled spring, 
artesian, mineral, or well water that is unmodified by mineral addition 
or deletion, except that ``natural water'' may be filtered and must be 
sanitized with ozone or an equivalent disinfection process and treated 
to reduce the concentration of any substance that exceeds an allowable 
level established by the agency.
    One comment urged FDA to define ``natural water'' as in the IBWA 
Model Code. IBWA defines ``natural water'' as spring, mineral, 
artesian, or well water that is derived from an underground formation 
and that is not derived from a municipal system or public water supply.
    Some comments recommended that FDA define ``natural'' for use on 
bottled water labels because the term is often used on labels and may 
be misused. One comment stated that water to be called and labeled 
``natural'' must come from the ground and may be sanitized with ozone 
or an equivalent disinfection process. It added that any removal of 
excessive substances should not allow that water to be labeled as 
``natural.'' Another comment stated that the word ``natural'' should be 
used only if the mineral content of the water is not altered during the 
production process. Therefore, distilled, purified, or drinking water 
products that use reverse osmosis to remove solids, then add back 
minerals, could not be described as ``natural.''
    One comment suggested that FDA provide for the use of the term 
``natural'' in conjunction with ``mineral water'' (i.e., ``natural 
mineral water'') as it is allowed in the European standard. The comment 
stated that consumers want to be assured that the product that they are 
purchasing is from a natural source and has not been blended or 
manipulated in any fashion with surface or municipal water sources. The 
comment added that the use of the term ``natural'' also implies that, 
because of the bacterial purity of the product, chemical disinfection 
is not necessary.
    Two comments suggested the addition of the word ``natural'' to the 
definition of ``spring water'' to fully ensure that the spring water 
has the same composition, whether collected through a bore hole or at 
the surface, and that it has not been treated except for the addition 
of carbon dioxide or the removal of iron and manganese and suspended 
solids.
    However, two comments stated that the term ``natural water'' should 
not be permitted on a label because consumers do not understand what it 
means.
    The agency considered establishing a definition for ``natural'' in 
a proposal on food labeling that it published in the Federal Register 
of November 27, 1991 (56 FR 60421 at 60466), because of the widespread 
use of the term and the evidence that consumers regard many uses of 
this term as noninformative. After considering the comments that it 
received in response to the November 27, 1991 proposal, the agency 
stated that if the term ``natural'' were adequately defined, the 
ambiguity surrounding use of this term that results in misleading 
claims could be abated (58 FR 2302 at 2407, January 6, 1993). Because 
of resource limitations and other agency priorities, however, FDA did 
not undertake rulemaking to define ``natural'' at that time. The agency 
stated that, while it regarded the term as meaning that nothing 
artificial or synthetic has been included in, or has been added to, a 
food that would not normally be expected to be in the food, it would 
maintain its policy of not restricting the use of the term except as 
provided for in Sec. 101.22 (id.).
    A number of States, AFDO, and IBWA have defined ``natural water'' 
(Refs. 2, 7, 11, 12, 14, and 15). All of the definitions require that 
the water be derived from an underground formation (spring, artesian, 
or well water) and be unmodified except for limited treatment (e.g., 
filtration and ozonation or equivalent disinfection process). Those 
States that have adopted the IBWA model regulation as their State 
regulation provide for treatment of ``natural water'' to reduce the 
concentration of any substance that exceeds safety standards. The IBWA 
model regulation also states that the water ``may be collected and 
transported by pumps, pipes, tunnels, trucks, or similar devices.''
    The Codex Standard for Natural Mineral Waters and Edible Ices and 
Ice Mixes (Codex Standard) (Ref. 1) defines ``natural mineral water'' 
and ``naturally carbonated natural mineral water.'' These waters are 
obtained from underground water-bearing strata either through natural 
flow or drilling. Treatments permitted for ``natural mineral water'' 
under the Codex standard include separation from unstable constituents 
by decantation or filtration that is, if necessary, accelerated by 
previous aeration.
    The agency finds that the IBWA code and State requirements are 
basically consistent with FDA's informal policy on ``natural'' because 
the product is only minimally processed. However, there are some 
surface waters (e.g., water collected from glacier runoff) that may 
only require minimal processing to be acceptable bottled waters and, 
thus could qualify to be called ``natural.'' Most surface waters and 
ground waters under the influence of surface water require additional 
processing to ensure that the water is consistent in quality and, thus 
could not be labeled as ``natural.'' Therefore, because FDA's informal 
policy already encompasses bottled water, the agency concludes that it 
is not necessary to establish a regulation that specifically defines 
``natural'' for use with bottled water.
    59. One comment noted that no consideration was given to the proper 
use of the word ``pure.'' It stated that many bottlers misuse this 
word.
    The agency advises that while there is no specific prohibition 
against the use of the term ``pure,'' it has discouraged the use of the 
term because it is ambiguous and may be misleading (58 FR 2897 at 
2903). For example, ``spring water'' and ``pure spring water'' may be 
identical foods, but ``pure,'' as applied to the food, implies that 
other identical products are ``impure'' or ``not pure'' if they do not 
bear the same term on their label. In addition, the agency notes that 
the term ``pure'' may be confused with the term ``purified,'' and 
consumers may be misled into believing that bottled water labeled as 
``pure'' has been treated to substantially decrease the total dissolved 
solids content.
    The agency is not convinced that it should use its resources to 
define the term ``pure'' at this time but will continue to discourage 
its use. In addition, the agency will continue to deal with this issue 
on a case-by-case basis.
    60. Two comments asked what bottled waters made by using well water 
for a source, and then diluting the water with distilled or purified 
water to improve hardness and taste, could be called.
    Blends of different types of water, such as well water and purified 
water, 

[[Page 57100]]
may be appropriately labeled as ``bottled water'' or ``drinking 
water.'' Truthful statements may also be made on the label to inform 
consumers that the product is blended, with the percentage of each type 
of water included.
    61. Two comments stated that the name ``mountain water'' should not 
be permitted on the label because it is misleading to consumers.
    The agency is not providing for the use of the term ``mountain 
water'' as the name of a bottled water product. The name of the product 
is ``bottled water,'' ``drinking water,'' or one or more of the terms 
defined in Sec. 165.110(a)(2) as appropriate. However, if the water is 
from a mountain source, manufacturers may include a truthful and 
nonmisleading statement reflecting that fact.
    62. One comment stated that there are bottlers in Canada and Alaska 
that bottle ``glacier water'' and asked whether they could continue to 
use this term to label their bottled water. It provided a definition 
for ``glaciofluvial'' as ``of or relating to or coming from streams 
deriving much or all of their water from the melting of a glacier.'' 
The comment stated that minerals are rarely detectable in this water, 
let alone environmental pollutants, and noted that the water requires 
little if any filtration. The comments said that the water is passed 
through ozonation or ultraviolet light as a precaution for total and 
fecal coliform bacterial counts.
    FDA notes that the definition that the comment provided is not a 
clear definition because, under it, not all of the water need come from 
the melting of the glacier, and the percentage of the water actually 
coming from the glacier would vary significantly according to the 
season of the year. Therefore, FDA is not providing for this term.
    FDA notes that manufacturers that bottle this category of water may 
state in the labeling that the source of the water is glaciofluvial. 
However, the statement of identity for the product is ``bottled water'' 
or ``drinking water.''

D. Other Label Statements

1. Mineral Content of Mineral Water
    The agency tentatively concluded in the January 1993 proposal that 
the listing of relative mineral content is useful to consumers to 
characterize a given mineral water product. FDA proposed to require 
that if the TDS is below 500 ppm, the statement ``low mineral content'' 
appear on the label. In addition, the agency proposed that if the TDS 
of mineral water is more than 1,500 ppm, the statement ``high mineral 
content'' must appear on the label. FDA did not propose to define the 
term ``light'' or other descriptive terms as they apply to mineral 
water because FDA tentatively concluded that the use of only the 
statements ``low mineral content'' and ``high mineral content'' would 
be less confusing to consumers. FDA proposed that the statement of 
mineral content appear on the principal display panel following the 
statement of identity in type at least one-half the size of the type 
used for the statement of identity but in no case of less than one-
sixteenth of an inch. The agency requested comments concerning the 
proposed levels defining high or low mineral content.
    63. A number of comments noted that Sec. 165.110(a)(3)(i) 
concerning the labeling of a product as ``low mineral content'' or 
``high mineral content,'' does not refer solely to ``mineral water'' 
and objected to this labeling if it were to apply to all bottled 
waters. One comment stated that the statement ``low mineral content'' 
would be misleading on products such as ``artesian water,'' ``spring 
water,'' ``well water,'' or ``bottled water'' when they in no way claim 
to be mineral water, and this statement would imply a less-than-normal 
mineral content. One comment recommended that the regulation state ``if 
the TDS content of mineral water is below * * *,'' so that the 
regulation only would apply to products labeled as mineral water.
    FDA agrees with the comments. The normal mineral content of 
artesian water, spring water, well water, bottled water, or any other 
bottled water product except for the majority of mineral waters is less 
than 500 ppm TDS. In fact, bottled water, except for mineral water, 
must comply with the provisions in the quality standard for bottled 
water that require that if the product contains more than 500 ppm TDS, 
the product be labeled as substandard (Secs. 165.110 (b)(4) and (c)). 
In the preamble to the proposal, the agency only discussed labeling a 
product as ``low mineral content'' or ``high mineral content'' if the 
product was ``mineral water'' (58 FR 393 at 397), although the agency 
failed to specifically mention in the regulation that it applied only 
to ``mineral water.'' This failure was an oversight. Therefore, the 
agency is modifying Sec. 165.110(a)(3)(i) to state that if the total 
dissolved solids (TDS) content of mineral water is below 500 ppm, or if 
it is greater than 1,500 ppm, the statement ``low mineral content'' or 
``high mineral content'', respectively, shall appear on the principal 
display panel.
    64. A number of comments objected to the labeling of mineral water 
as ``low mineral content'' and ``high mineral content'' and requested 
that Sec. 165.110(a)(3)(i) be deleted because this labeling would be 
confusing to consumers. One comment opposed denoting the ``low'' or 
``high'' mineral content of mineral water because flavor is more 
affected by specific minerals than by TDS.
    FDA disagrees that the label statements concerning low or high 
mineral content should be deleted from the regulation. As discussed 
previously, the agency is requiring that mineral water contain a 
certain amount of minerals because consumers expect that mineral water 
contains some minerals. Because the mineral content of mineral water 
may vary greatly, and because the high and low ends of the range of 
mineral contents may have a significant bearing on the characteristics 
of the water, the agency concludes that information about the mineral 
level is a material fact, under section 201(n) of the act, in 
conjunction with the term ``mineral water.'' The agency's action 
establishes three broad categories, but only manufacturers of mineral 
waters below 500 ppm TDS or above 1,500 ppm TDS need provide the 
additional information on the label.
    FDA agrees that the taste of some mineral waters may be affected 
more by specific minerals than by total mineral content. Nevertheless, 
if a mineral water contains less than 500 ppm TDS, it is important that 
consumers be made aware that the product has a low mineral content, and 
that it may not have the mineral taste that another mineral water may 
have. Many State regulations have required that mineral water contain 
more than 500 ppm TDS (Ref. 8), and most mineral water sold in the 
United States has complied with this minimum so that it could be sold 
in those particular States. Therefore, FDA concludes that the use of 
the statement ``low mineral content'' on mineral water containing less 
than 500 ppm TDS is appropriate to alert consumers to the fact that the 
water may have a lower mineral content than mineral waters that they 
have previously purchased.
    Additionally, the agency notes that, as discussed in the proposal 
to this final rule (58 FR 393 at 397), a mineral content of over 1,500 
ppm TDS greatly affects the taste of the water no matter what the 
specific minerals may be. Therefore, the agency concludes that because 
this information is a material fact, consumers should be informed that 
the product contains a high mineral content. 

[[Page 57101]]

    65. Two comments held that the statement ``low mineral content 
water'' on mineral water could be misleading to some consumers if, for 
example, they interpret it as saying that the water is low in sodium. 
The comment stated that low mineral content mineral waters may be 
relatively high in sodium.
    FDA disagrees that the statement ``low mineral content'' would be 
misleading to consumers. The term ``low'' in this statement is 
referring to the overall total dissolved solids content and not to any 
specific mineral. However, the agency agrees that some mineral waters 
containing between 250 and 500 ppm TDS may contain more than an 
insignificant amount of sodium. Under Sec. 101.9(a), nutrition labeling 
is required if the product contains more than an insignificant amount 
of any nutrient that is required to be included in the declaration of 
nutrition information under Sec. 101.9(c). If a product labeled as 
``low mineral content'' is not sodium free (i.e., contains 5 or more mg 
sodium per serving), nutrition labeling is mandatory, and consumers 
will be informed that, although the product is low in mineral content, 
it contains more than an insignificant amount of sodium.
    66. Four comments asked whether mineral waters with a mineral 
content greater than 1,500 ppm could be labeled as ``rich in mineral 
salts.''
    Another comment stated there may be confusion about the term ``high 
mineral content'' because it appears to be substantially similar to 
nutrient content claims that are allowed under the Nutrition Labeling 
and Education Act of 1990 (the 1990 amendments), and in fact it may be 
misinterpreted by many consumers as an indication that the product may 
be useful as a mineral supplement.
    The agency finds no merit to these comments. In the Federal 
Register of January 6, 1993 (58 FR 2302 at 2414), FDA adopted 
Sec. 101.54(b)(1), which defines the terms ``high,'' ``rich in,'' and 
``excellent source of'' to mean that the food contains 20 percent or 
more of the reference daily intake (RDI) or the daily reference value 
(DRV) of the nutrient in question per reference amount customarily 
consumed. The claim ``high mineral content'' is not subject to 
Sec. 101.54 because the term does not describe the nutrient content of 
the water. FDA has not defined nutrient content claims for minerals as 
a category, only for individual minerals. While FDA has authorized some 
nutrient content claims concerning mineral content of foods, such as 
``high in three minerals,'' it has not authorized ``high mineral 
content.'' Thus, this claim only applies to mineral water.
    There is no authorization in FDA's regulations for use of a synonym 
for ``high'' in the statement ``high mineral content'' for bottled 
water because the statement is not a nutrient content claim but part of 
the statement of identity of the product. The term ``rich'' is not 
appropriate in this context because it means that a product is 
abundantly supplied with something of value. Although the terms 
``high,'' ``rich in,'' and ``excellent source of'' have been defined as 
synonymous nutrient content claims, not all of these terms are 
appropriate when used to describe the mineral content of mineral water 
containing more than 1,500 ppm TDS because such water may not be an 
``excellent'' or ``rich'' source of minerals of nutritional 
significance. Use of the term ``high mineral content,'' however, 
provides a quantitative contrast to the term ``low mineral content'' of 
mineral water containing less than 500 ppm TDS.
    Therefore, FDA concludes that only the declaration ``high mineral 
content'' is appropriate for mineral water. Given that the statement is 
part of the statement of identity of the product, FDA has not provided 
for the use of synonyms. The statement appropriately should be as 
simple and as straightforward as possible.
    67. One comment stated that 1,500 ppm TDS as the triggering level 
for the label statement ``high mineral content'' is an extremely high 
level. The comment suggested that the statement ``exceeds the secondary 
maximum contaminant level of 500 ppm,'' for mineral water containing 
greater than 500 ppm TDS, is a better disclosure and would help to 
eliminate consumer confusion over the differences in water quality 
standards between bottled water and public tap water.
    The agency disagrees with the comment. The term ``mineral water'' 
has traditionally implied that the water has a higher mineral content 
than most water, including public tap water. As discussed in the 
proposal (58 FR 393 at 397), all water contains some minerals, unless 
it has been demineralized (Ref. 16). Thus, the agency tentatively 
concluded that consumers expect that a product identified as ``mineral 
water'' would contain at least a minimum level of minerals. This 
expectation is reinforced by the fact that some States (Ref. 8) have 
only included water that contains more than 500 ppm TDS in their 
definition of ``mineral water.''
    The label declaration ``high mineral content'' is to inform 
consumers that the mineral content is high in comparison to other 
mineral waters. As discussed in the proposal (58 FR 393 at 397), a 
mineral content of more that 1,500 ppm TDS greatly affects the flavor 
of the water. This level is consistent with the European Community 
definition of ``mineral water--rich in mineral salts'' (Ref. 17) and 
will not hinder international trade. Thus, the comment has not 
persuaded the agency that 500 ppm TDS is a more appropriate minimum 
level than 1,500 ppm TDS for a product labeled as ``mineral water, high 
mineral content.''
    Therefore, to ensure that consumers know that the product that they 
are purchasing is high in minerals as compared to other mineral waters, 
the agency is requiring in Sec. 165.110(a)(3)(i) that the label of 
mineral water containing more than 1,500 ppm TDS include the statement 
``high mineral content.''
    68. Several comments recommended that FDA require that TDS content 
appear on the label of all bottled waters because: (1) Consumers will 
more easily relate bottled water designations to their specific TDS 
ranges, (2) consumers will have a better chance of purchasing a bottled 
water corresponding to their tastes if they learn to associate a 
particular level of TDS with those tastes, and (3) it renders 
unnecessary the ruling that a mineral water with a TDS higher than 
1,500 ppm be labeled as ``high mineral content.'' One comment stated 
that consumers will rapidly relate TDS content values in the range of 
``thousand(s)'' with a ``high mineral taste'' without the need for 
arbitrary qualifiers. It added that a TDS labeling requirement works 
towards establishing similar standards between Canada and the United 
States.
    One comment stated that it would be more informative to consumers 
to list the TDS in the side panel because concerned consumers want hard 
information, not generalities like the relative mineral content 
statements that the agency proposed. It stated that there is a gray 
area between 250 and 500 ppm TDS in which some waters may taste 
distinctive and others may taste undistinctive, like low-TDS spring 
water.
    FDA disagrees that it should require mandatory declaration of TDS 
level. The agency stated in the proposal that many consumers may not 
understand the relevance of a specific TDS and, thus, tentatively 
concluded that there is no substantive basis on which to require that 
this information appear on the label (58 FR 393 at 397). None of the 
comments provided any information that showed that consumers would 
understand the significance of this information and that would support 
a conclusion different than FDA's 

[[Page 57102]]
tentative determination. However, the agency will not object if 
manufacturers include information concerning the TDS content, or any 
information relating to a distinctive taste of a specific product, on 
their labels as long as the information is truthful and not misleading.
    Because many consumers will not understand the relevance of a 
specific TDS (Ref. 16), FDA concludes that the requirement to label 
mineral water as ``low mineral content'' or ``high mineral content,'' 
as appropriate, will be generally more informative to consumers than 
TDS labeling. Therefore, the agency concludes that mandatory labeling 
of TDS is not necessary, and that there is no substantive basis on 
which to require that this information appear on the label.
    69. One comment remarked that all bottled water should be labeled 
with the percentage of minerals present and the limits allowed. Another 
comment encouraged actual content disclosure on bottled water labels, 
stating that consumers have a right to know whether any substance 
regulated under the Safe Drinking Water Act (the SDWA) is contained in 
the bottled water they purchase, even though it would have to be 
present at a level below the Maximum Contaminant Level (MCL) 
established as being permissible.
    The agency disagrees that this additional labeling should be 
required. MCL's have not been established for all minerals or other 
substances that may be in bottled water. FDA established the standard 
of quality for bottled water to require that bottled water meet certain 
quality specifications or else be clearly labeled as ``substandard.'' 
The quality standard for bottled water is based on EPA's regulations 
for public drinking water (40 CFR parts 141 and 143), and EPA 
establishes its regulations based on health and aesthetic 
considerations. Thus, any contaminant present at a level lower than its 
maximum allowable level is not considered a safety or quality concern.
    Given this fact, there is no basis to require the information that 
the comments requested. The information would not be a material fact, 
and thus there would be no basis to claim that the product is 
misbranded if the information is not disclosed. The presence of these 
substances in bottled water at levels meeting the quality standard is 
inconsequential. The appearance of this information on the label may be 
confusing and may imply that the substance is present in excessive 
amounts when it is not. Therefore, the agency concludes that the 
requested additional labeling is not warranted.
    70. One comment requested that FDA add the following language to 
Sec. 165.110(a)(3)(i): ``Mineral water products falling between the TDS 
values of 500 to 1,500 mg/L do not have to add additional terms.''
    The agency notes that mineral water containing more than 500 ppm 
TDS and less than 1,500 ppm TDS need not bear labeling on relative 
mineral content. Although a specific statement to this effect is not 
necessary in the regulation, FDA is modifying Sec. 165.110(a)(3)(i) to 
state that if the TDS of mineral water is between 500 and 1,500 ppm, no 
additional statement need appear. The agency concludes that this 
modification will clarify the regulation.
    71. One comment suggested that the producers of identified, sole-
source bottled water products (e.g., artesian or mineral waters) that 
desire to market their products based on the naturally occurring 
mineral contents be allowed to label their products: ``Water with (or 
containing) naturally occurring minerals,'' provided that the product 
labeling clearly identifies the water's sole source and also identifies 
the naturally occurring minerals. It stated that such mineral 
identification in the labeling of natural, identified sole-source water 
should not require additional nutrition information.
    The agency disagrees with the comment. All water, unless it has 
been treated to remove minerals or has had minerals added, contains 
naturally occurring minerals, regardless of whether it comes from an 
identified single source. A statement such as ``water with naturally 
occurring minerals'' has the potential to be misleading to consumers 
because it implies that the products of competitors may contain added 
minerals or have had minerals removed, when, in fact, they have not. 
However, manufacturers may use the term ``natural'' on their bottled 
water labels if they follow FDA's informal policy as discussed 
previously (see comment 58) of this document.
    The agency is not defining the statement ``water with naturally 
occurring minerals'' for bottled water labels at this time because it 
has no basis to conclude that use of the statement would not be 
misleading, or that it would be useful to consumers. The comment did 
not provide sufficient information on which to base a regulation.
2. Water From a Municipal Supply
    The agency proposed to require that the phrase ``from a municipal 
source'' appear on the principal display panel or panels as a part of 
the name of the food if the water is obtained from a municipal water 
supply, except if the water has been treated to meet the definitions of 
distilled water or purified water (58 FR 393 at 399). FDA also proposed 
to require that the statement appear on the principal display panel 
following the statement of identity in type at least one-half the size 
of the type in which the statement of identity appears but in no case 
less than one- sixteenth of an inch. The agency also proposed to 
require that the statement immediately and conspicuously precede or 
follow the name of the food without intervening written, printed, or 
graphic matter, other than statements required by proposed 
Sec. 165.110(c).
    72. Two comments suggested that FDA use the term ``public water 
supply'' as defined by EPA rather than use the term ``municipal 
supply.'' The comments noted that the use of the term ``public water 
supply'' would avoid confusion, as FDA would be using a term that is 
already defined and well understood. One comment stated that questions 
could arise about the definition of a ``municipal supply,'' such as how 
many people would a supply be required to serve to meet the definition 
of a ``municipal supply.'' Another comment stated that the term 
``public water system'' is a more appropriate term because it would 
include the numerous water systems that are independent water purveyors 
not affiliated with specific municipalities.
    The agency disagrees that the statement ``from a municipal source'' 
should be replaced with ``from a public water supply'' or ``from a 
public water system'' in Sec. 165.110(a)(3)(ii). EPA defines a ``public 
water system'' as a system that provides piped water for human 
consumption and that: (1) Has at least 15 service connections, or (2) 
regularly serves at least 25 persons at least 60 days per year (40 CFR 
141.2). Public water systems are split into two categories: Community 
and noncommunity water systems. Community water systems are systems 
that regularly serve 25 or more year-round residents (or have at least 
15 service connections used by year-round residents) (40 CFR 141.2). 
Many factories, restaurants, schools, parks, and rest areas also 
operate their own supply of drinking water. However, these systems do 
not have the required residential community and are, thus, considered 
noncommunity systems.
    There are two types of noncommunity water systems: Transient 
noncommunity or nontransient noncommunity (40 CFR 141.2). 

[[Page 57103]]
Transient noncommunity systems serve travelers and other transients at 
locations such as highway rest stops, small restaurants, and public 
parks. The system serves at least 25 people a day for at least 60 days 
per year but typically not the same 25 people each day (40 CFR 141.2). 
On the other hand, nontransient noncommunity water systems do serve the 
same 25 persons for at least 6 months a year but not on a year-round 
residential basis (40 CFR 141.2). Schools and workplaces that have 
their own water supply and serve at least 25 of the same persons each 
day are examples of these systems.
    The agency stated in the proposal (58 FR 393 at 399) that 
information about the actual source of a bottled water product is a 
material fact in light of either the explicit (e.g., use of terms such 
as ``spring'' or ``well'') or implied (the presentation of the product 
in the bottle) representation made by a bottled water product that the 
product is not tap water. Information about the source of the water is 
necessary to ensure that consumers do not incorrectly assume that 
because water is sold in a bottle it is not tap water.
    According to 40 CFR 142.2, a ``municipality'' means a city, town, 
or other public body created by, or pursuant to, State law. Municipal 
water sources are systems that serve municipalities. Thus the term 
``municipal source'' may be too narrow to encompass all types of tap 
water sources. Independent water purveyors and other community systems 
may operate similarly to municipal water sources, rely on the same 
types of water (e.g., surface water), use the same type of treatments 
of the water, and supply the water that flows from a tap. They may 
differ from a municipal source only in that they are not affiliated 
with a municipality.
    Thus, FDA agrees that water from water systems that are independent 
water purveyors, but that are not affiliated with specific 
municipalities, should bear labeling that makes clear its source. 
Clearly, what would be considered a municipal source would be 
encompassed by the definition of a community water system because a 
source supplying an incorporated city or town would regularly serve 25 
or more people on a year-round basis (or have the minimum 15 year-round 
service connections). The term ``community water system'' would 
encompass the independent water purveyors that the term ``municipal 
source'' would not.
    Noncommunity water systems by definition would not serve a 
municipality. FDA notes that some bottled water firms may meet the 
definition of a nontransient noncommunity system if they employ at 
least 25 persons and use the source water as the workplace water 
supply. The intent of the labeling requirement was not to include these 
bottled water manufacturers. Their water is considered a public water 
system only because they choose to use their own water source and not 
pipe water in from another source for their workplace water supply.
    Therefore, the agency concludes that bottled water from a community 
water system, as defined by EPA (40 CFR 141.2), must bear source 
labeling. FDA finds that including all community water system sources 
in Sec. 165.110(a)(3)(ii) is the logical outgrowth of the January 5, 
1993, proposal because the intent of the proposal, as explained above, 
was to cover all tap water. Thus, FDA is revising 
Sec. 165.110(a)(3)(ii) to apply to bottled water coming from a 
community water system as defined in 40 CFR 141.2, rather than from a 
municipal source. Alternatively, manufacturers may label their product 
as ``from a municipal source'' if appropriate. (Moreover, as explained 
in comment 96 of this document, there may be some instances in which 
``from a public water supply'' or ``from a public water system'' is 
appropriate.)
    73. One comment disagreed with the provision that would exempt 
purified water from having to be labeled as from a municipal supply. It 
stated that the process does not change the source.
    Although the agency acknowledges that purification does not change 
the source, FDA concludes that the exception for purified water is 
appropriate. As FDA stated in the proposal (58 FR 393 at 399), 
consumers purchase purified water because of its treatment and 
resultant purity rather than because of its source. In addition, 
because purified water and distilled water must meet the compositional 
requirements of the USP monograph for purified water, there are no 
significant compositional differences among purified and distilled 
waters, regardless of the source of the water. Source information for 
purified waters is not a material fact because the water may be 
significantly different in composition than other water from that 
particular source. Thus, the absence of source information for purified 
water is not misleading under section 403(a) of the act. The comment 
did not present any information other than the basic argument 
summarized above. Thus, FDA is not making any changes in response to 
this comment. However, manufacturers may optionally include source 
information on the label of purified water.
    74. Several comments stated that proposed Sec. 165.110(a)(3)(ii) 
implies that if bottled water from a municipal source has been treated 
to meet the definition of ``purified'' or ``distilled water,'' it may 
be exempt from the labeling declaration of ``from a municipal source,'' 
whether or not the product is labeled as ``purified water'' or 
``distilled water.'' The comments stated that the circumstances in 
which the municipal source of the water need not be disclosed should be 
limited, as the agency apparently intended, to when the water is 
labeled as ``purified'' or ``distilled.'' To effect this limitation, 
the comments suggested that the agency add the words ``and is labeled 
as such'' to the regulation.
    The agency agrees with the comments. In the preamble to the 
proposal, the agency stated that the exemption would apply only to 
purified water or distilled water that was labeled as such (58 FR 393 
at 399). However, FDA failed to include the statement ``and is labeled 
as such'' in the regulation. Therefore, FDA is modifying 
Sec. 165.110(a)(3)(ii) to include this requirement.
    In addition, because FDA has included the alternative terms 
``deionized water,'' ``demineralized water,'' ``purified drinking 
water,'' and ``reverse osmosis water'' in the definition of purified 
water, the agency is modifying Sec. 165.110(a)(3)(ii) to include all of 
the terms that may be used under Sec. 165.110(a)(2)(iv) in the 
exemption.
    75. One comment requested that, if the source of bottled water 
labeled as ``sterilized water'' is a municipal source, the product be 
exempt from the labeling requirements in Sec. 165.110(a)(3)(ii).
    The agency agrees that use of the terms ``sterile'' or 
``sterilized'' on the label of bottled water should exempt it from the 
requirements of Sec. 165.110(a)(3)(ii). Sterile water has undergone a 
treatment to meet strict microbiological standards. Purified water is 
exempt from the requirements of Sec. 165.110(a)(3)(ii) in part because 
the process of purification removes many substances that are typical of 
the source water, and also because there are no significant differences 
between purified waters even though the source waters may be very 
different. Consumers may purchase purified water and sterile water 
because of the specific treatment and not the source of the water. In 
addition, because sterile water must meet the microbiological 
requirements of the USP definition for ``sterile,'' there are no 
significant microbiological 

[[Page 57104]]
differences among sterile waters, regardless of the source of the 
water. Source information for sterile waters is not a material fact 
because the water may be significantly different in microbiological 
content than water from that particular source. Thus, the absence of 
source information for sterile water is not misleading under section 
403(a) of the act.
    Therefore, the agency is modifying Sec. 165.110(a)(3)(ii) to exempt 
sterile water and sterilized water that is from a community water 
system from the source labeling requirement.
    76. One comment stated that FDA overlooked source labeling of 
partially purified water from a municipal source that is processed to 
remove some chemicals but does not meet the requirements of purified 
water.
    FDA disagrees with the comment and affirms that water from a 
community water system that is partially purified (i.e., it does not 
meet the definition of purified water) does not qualify for an 
exemption from the requirements of Sec. 165.110(a)(3)(ii). As discussed 
above under comment 74 of this document, there are no significant 
compositional differences between purified and distilled waters, 
regardless of the source of the water. Partially purified water, 
however, effectively continues to resemble the source water. Because 
partially purified water does not qualify for the exemption, it is 
covered by Sec. 165.110(a)(3)(ii). Therefore, if the water is partially 
processed, and is from a community water source, the label must declare 
the latter fact.
    77. One comment stated that it would be misleading if a country 
setting is shown on the label, including lakes or ponds, and the 
product is drinking water processed from municipal supplies via reverse 
osmosis systems.
    FDA agrees that the use of certain graphics on a label of bottled 
water may be misleading to consumers if the source of the water is 
different than the source depicted or implied. For example, a country 
setting on a label may mislead consumers into believing that the 
product is spring water when it is not. Section 403(a) of the act 
specifically states that a food shall be deemed to be misbranded if its 
labeling is false or misleading in any particular. If a product is from 
a community water system, the label must clearly disclose this fact 
except as provided in Sec. 165.110(a)(3)(ii).
    78. Several comments stated that FDA has not provided, except in 
Sec. 129.80(a), for the long-established industry practice of adding 
minerals to adjust the taste of water that has been previously treated 
to meet the definition of ``distilled'' or ``purified water.'' One 
comment stated that water that is purified to meet the definition for 
``purified water,'' and subsequently has minerals added back to it, 
should be exempt from the source labeling requirement in 
Sec. 165.110(a)(3)(ii) because it has a totally different composition 
than other water from the municipal source. It stated that the labeling 
could indicate that the water was purified or distilled, and that 
minerals had been added for flavor. Another comment stated that this 
approach would allow for flexibility in labeling while providing 
adequate information for the consumer.
    FDA advises that water from a community water system that has been 
treated to meet the definition of ``purified water'' in 
Sec. 165.110(a)(2)(iv), and is labeled as ``purified water'' or one of 
its alternative names, is exempt from the labeling requirements of 
Sec. 165.110(a)(3)(ii). Water with minerals added for taste is 
considered a multi-component food, and the labeling ``from a municipal 
source'' describes only the water ingredient. Thus, if minerals are 
added to purified water for taste, and the label states that the 
product is ``purified water (or any of its alternative names) with 
minerals added for taste,'' the product is exempt from 
Sec. 165.110(a)(3)(ii) because the water ingredient meets the criteria 
for the exemption.
    79. Some comments agreed with the requirement in 
Sec. 165.110(a)(3)(ii) but stated that the name of the source, be it a 
municipal source, water authority, or any other public water system, 
should be specifically included on the label so that the consumer may 
obtain water quality test results, such as those maintained by the 
public water system or the relevant regulatory agency. One comment 
stated that consumers may then compare water quality results of the 
bottler with those of the public water system selling the water to the 
bottler, and consumers could contact the municipal source and ascertain 
whether a bottler is using a municipal source that adds fluoride to its 
finished water.
    Other comments requested that all bottlers of water list on the 
label the source of the product contained in the bottle. Comments asked 
that, for full disclosure, bottled water labels include the name of 
manufacturer, address of source, and well number or spring's legal 
name, so that consumers will know specifically from where the water 
comes. One comment noted that many States require the geographic source 
identity. Another comment added that many companies are misrepresenting 
their products to the consumer by vague labeling.
    FDA does not object to the optional label declaration of more 
specific information concerning the water source because such 
information may be useful to some consumers. However, the agency does 
not agree that it should require specific water source labeling, or 
that the lack of such labeling means that the label is misleading and 
vague.
    Under section 201(n) of the act, the agency must consider whether 
the information is a material fact whose nondisclosure will render the 
labeling misleading. Under this standard, it is difficult to see why 
the name of the specific source, be it a public water supply, spring, 
or well, would be a material fact. The agency requires that the product 
water supply for each bottled water plant be from a source that is 
inspected and approved by the government agency having jurisdiction 
(Sec. 129.3(a)). The product water supply must be properly located, 
protected, and operated, and must be easily accessible, adequate, and 
of a safe, sanitary quality that is in conformance at all times with 
the applicable laws and regulations of the government agency having 
jurisdiction (Sec. 129.35(a)(1)). Thus, the specific name of the source 
is not material to ensure the safety of the product.
    In addition, the water must meet the requirements of the quality 
standard in Sec. 165.110(b) or be labeled as substandard. Thus, the 
identity of the specific source is not material to ensure the quality 
of the product.
    Finally, in this final rule FDA is providing for the use of 
alternative names that generally describe the source of the water 
(e.g., artesian, spring, and well). Thus, consumers can have confidence 
that bottled water labeled as being from a certain type of water source 
is from a source meeting an appropriate definition.
    Therefore, the agency concludes that the absence of information 
concerning the exact water source (e.g., specific municipal source, the 
well number, spring's legal name, address of the source) is not a 
material omission that would render the labeling misleading because 
bottled water must meet FDA's requirements which provide the consumer 
with assurances as to the safety, quality, and type of source. While 
the agency recognizes that some States require the geographic source 
identity, FDA simply is not persuaded that the additional information 
is a material fact that must be disclosed.
    The brand name and the name of the manufacturer distinguish bottled 
waters as much as specific source labeling 

[[Page 57105]]
would. According to Sec. 101.5(a), the label of a food in packaged form 
must specify conspicuously the name and place of business of the 
manufacturer, packer, or distributor. This labeling requirement 
provides consumers with the necessary information to contact the firm 
and obtain information (e.g., the name and location of the source, the 
well number, or the spring's legal name) that is not provided on the 
label if they are interested. Therefore, FDA concludes that there is no 
basis on which to require that information concerning the specific 
source of bottled water appear on the label.
3. Water for Infant Use
    The agency proposed to require notice on the principal display 
panel of bottled water products that are promoted for infant use that 
such products are not sterile (if such is in fact the case), and that 
they should be used as directed by a physician or by infant formula 
preparation instructions (58 FR 393 at 400).
    80. One comment stated that Sec. 165.110(a)(3)(iii) should read: 
``When the label or labeling characterizes the bottled water in any 
manner * * * as for feeding infants, and the product is not 
commercially sterile, within the meaning of the term at 21 CFR 
113.3(e), the principal display panel shall bear conspicuously the 
phrase * * *.'' The comment stated that a qualification of the phrase 
``not sterile'' to ``not commercially sterile'' would clarify that, by 
use of the term ``sterile,'' the agency does not intend to require that 
bottled water for infant food use meet the requirements of the USP 
monographs for sterile waters which are compendial pharmaceutical 
articles in themselves. It stated that there is no safety concern that 
necessitates that bottled water for infant use meet a different 
standard than the standard applicable to hermetically sealed low-acid 
foods, and none has been articulated by FDA in the proposal.
    The agency agrees with the comment. As discussed previously, unless 
the label or labeling of a product that is labeled for use in feeding 
infants implies that the product meets USP requirements, FDA will not 
require that the product meet those requirements for sterility because 
commercial sterility is adequate. Canned infant formula is processed to 
be commercially sterile, as defined in Sec. 113.3(e), and the agency 
sees no reason to subject bottled water for infants to stricter 
requirements. Therefore, the agency is modifying 
Sec. 165.110(a)(3)(iii) to state that its provisions apply when the 
product is not commercially sterile under Sec. 113.3(e)(3)(i).
    81. A number of comments opposed the use of the phrase ``not 
sterile, use as directed by physician or by labeling directions for use 
of infant formula'' in Sec. 165.110(a)(3)(iii). The comments stated 
that infants, and even adults, do not require sterile foods but need 
foods that are free of pathogens, and that many health care 
professionals do not recommend sterilizing infant formula. Some 
comments submitted scientific publications to support their position 
that infants do not need sterile foods. They pointed out that infant 
medicines, oral preparations (vitamins), and breast milk are not 
sterile.
    Comments noted that it is difficult for parents to achieve and 
maintain sterility in infant preparations and stated that there is no 
difference between infant formulas prepared using a clean method and 
formulas prepared with sterile water. They stated that boiling bottled 
water that is not sterile may not be preferable to using water as it 
comes from the bottle because potentially harmful trace elements from 
the container used to boil the water may be concentrated during 
boiling. The comments maintained that, in some cases (e.g., areas not 
served by municipal supplies), bottled water may be a more reliable and 
superior source of water for infant use than other sources of water.
    Some comments held that the requirement for the use of the phrase 
``not sterile'' on infant formula or bottled water labeling is 
outdated, inappropriate, and may be unnecessarily alarming to 
consumers. They asserted that the phrase may have the unintended but 
harmful effect of giving a false sense of security to parents that 
would cause them, and perhaps cause the preparer of the infant formula, 
to ignore several important sources of bacterial risk.
    Comments stated that the recommendations calling for sterilization 
were made in the 1940's and 1950's, before the widespread practice of 
chlorination of municipal water supplies, and that bottled water 
products being marketed today go through a rigorous quality control 
program to eliminate pathogens. They maintained that there already are 
adequate industry standards in place, and that the phrase ``not 
sterile'' is not necessary.
    Some comments pointed out that all aqueous systems contain a 
normal, nonpathogenic microbial content, and that the absence of such a 
normal microbial content could in itself be indicative of the presence 
of a microbial antimetabolite in the water. Comments stated that a 
requirement for the label statement ``not sterile'' lacks technical 
merit and is contrary to FDA's position of not imposing plate count 
limitations on all food products. They stated that FDA provided no 
scientific rationale, hospital survey data, epidemiological health 
data, physician-use surveys, bottled water surveys, or any other 
reasonable, objective information to support this requirement. The 
comments held that sterilization does not provide a level of safety 
assurance equal to the assurance provided by the conjunction of 
protecting the aquifer from all risks of contamination and compliance 
with current good manufacturing practices (CGMP's), as demonstrated by 
the absence of microorganisms that are indicators of contamination 
(fecal bacteria).
    Other comments stated that requiring a statement that the water is 
not sterile would serve only to eliminate certain products from the 
bottled water market. They held that it would be grossly misleading, 
unjustified, and discriminatory to the infant water industry.
    Comments stated that the labeling recommended, but not required, by 
FDA for infant formula is to direct parents to consult with their 
physicians before using the product. The comments stated that this 
labeling of infant formula is to ensure that the parents are using the 
proper type and amount of formula for their babies, not because there 
was or should be concern about the water source used to mix the 
product. These comments recommended that FDA drop the requirement in 
Sec. 165.110(a)(3)(iii) entirely because such labeling gives medical 
advice to parents. As an alternative, comments suggested that labeling 
could state that ``parents should consult their physician for infant 
use.''
    Conversely, several comments supported the proposal because: (1) 
Infants are a high-risk group in terms of susceptibility to infections, 
(2) consumers will interpret a label ``water for infant use'' as not 
requiring any preparation before use in infant formulas, and (3) the 
disclosure required for bottled water marketed for use with infants or 
children is consistent with the objectives of FDA in promulgating these 
regulations. One comment added that labeling that can mislead a 
consumer to use nonsterile water in the belief that it is sterile may 
cause needless illness and possibly deaths.
    One comment stated that bottled water intended for the general 
population is used for a significant proportion of infants. It 
suggested a side 

[[Page 57106]]
panel statement on all bottled water products such as: ``If using to 
prepare infant formula, follow the mixing instructions on the infant 
formula label.'' Another comment suggested that each label reference to 
use for infant formula preparation be accompanied by a statement 
referring the consumer to the side panel usage instructions.
    However, another comment that supported the intent of the 
disclosure statement disagreed with the proposed labeling requirement 
for infant water. It stated that the proposed requirement in 
Sec. 165.110(a)(3)(iii) is a backward approach to public health 
protection for infants. The comment stated that bottled water promoted 
for infant use should be required to meet strict sterility 
requirements.
    FDA has considered these comments and, based on its consideration, 
concludes that labeling is necessary to inform consumers that bottled 
water labeled for infant use may not be sterile.
    The agency generally agrees with the conclusions of the scientific 
publications that the commenters submitted. Although the conclusions of 
the articles demonstrated that infants generally do not need to consume 
a sterile product, one publication noted that ``it is safer to feed an 
infant an almost sterile formula, than to feed him a formula with an 
unknown amount of contamination'' (Ref. 18). Use of appropriate 
ingredients and procedures in the preparation of infant formula is key 
in providing a suitable product for infant consumption.
    One study, concerning the inoculation of the digestive tracts of 
axenic mice with the autochthonous bacteria of mineral water, was 
conducted on 6-week-old mice and found that the autochthonous bacteria 
present in the mineral water from Vittel ``Grande Source'' were not 
able to establish themselves (i.e., to multiply and subsist in a great 
number) in the digestive tracts of axenic mice (Ref. 19). However, FDA 
questions whether these results apply to human infants because 6-week-
old mice are past an infant stage. In addition, only one source of 
water was used in the study, and the results cannot be extrapolated to 
water from other sources.
    The agency agrees with the comments that stated that nursing 
infants do not consume a sterile product, and that infants do not 
necessarily need to consume sterile products. However, although the 
heterotrophic bacteria present in water may not be harmful to the 
general population, high levels of some microorganisms, particularly 
opportunistic pathogens, may cause illness in some infants (Ref. 20). 
Parents need to be informed that bottled water labeled for infant use 
is not sterile because, without this statement, they may be led to 
believe that water labeled for infant use is sterile, and that its 
sterility is the characteristic that makes it appropriate for infant 
use. Thus, the agency concludes that bottled water intended for infant 
use should be at least commercially sterile or be labeled to inform 
consumers that it is not.
    There are essentially two situations in which an infant may consume 
infant water: (1) When it is used to reconstitute powdered infant 
formula or dilute concentrated liquid formula; and (2) when it is not 
used as an ingredient of the infant formula but is otherwise fed to 
infants, especially when used directly for feeding infants. If infant 
water was used only in the first situation, the labeling statement on 
infant water to ``use as directed on the infant formula labeling'' 
would be sufficient (and indeed, the additional statement ``use as 
directed by a physician'' would be redundant, since this statement is 
also required on the formula label). Concerns of sterility are 
adequately addressed on the infant formula label because under 
Sec. 107.20 (21 CFR 107.20), the product label must bear instructions 
for sterilization of water, bottles, and nipples when necessary for 
preparing infant formula for use. However, the second situation does 
not involve other appropriate labeling information. The second 
situation represents circumstances in which it would be appropriate to 
seek physician oversight, not only because of a potential concern about 
sterility, but also because of the concern about excessive feeding of 
water (and risk of hyponatremia) to infants.
    FDA agrees that once a package has been opened, it is subject to 
contamination. The process of preparing infant formula may also 
introduce other sources of contamination. The contamination of these 
foods from environmental sources and during preparation may not be 
harmful to most infants. However, parents must be aware of the fact 
that bottled infant water is not sterile, so that they may take special 
precautions if needed. Parents may be purchasing bottled infant water 
rather than using other sources of water including tap water and other 
types of bottled water specifically because they assume that the infant 
water is sterile.
    The agency is not advocating that parents boil bottled water that 
is not sterile and that is intended for infants. However, parents need 
to use infant water as directed by their physicians or by the labeling 
for infant formula. The agency stated in the final rule concerning 
labeling requirements for infant formula that ``potable,'' ``sterile,'' 
or ``pure drinking water'' must be used in preparing infant formula (50 
FR 1833 at 1836, January 14, 1985). As stated previously in the 
response to this comment, under Sec. 107.20(a)(3), infant formula 
labels must bear directions for sterilization of water, bottles, and 
nipples when necessary for preparing infant formula for use. In 
addition, Sec. 107.20(b) requires that a pictogram appear on the label 
depicting the major steps for preparation of that infant formula. One 
of the steps in the example provided in the regulation includes an 
accompanying statement that sterilization is recommended, and that the 
infant's physician will decide if it is not required.
    Thus, while it is true that recommendations for sterilization of 
water for infant use were made before the widespread practice of 
chlorination of municipal water supplies, FDA's regulations provide 
that sterilization should occur unless the physician decides otherwise. 
Parents need to consult with the infant's physician to determine 
whether sterilization is not necessary. The labeling requirement on 
bottled water is necessary to inform parents that the water is not 
sterile. Thus, if the physician says that sterilization of the infant's 
water is necessary, the parents will know that it is necessary to take 
appropriate steps to provide the infant with sterile water.
    FDA agrees that bottled water ordinarily contains a normal 
microbial content unless treated. As some comments pointed out, the 
reason for the absence of microorganisms in bottled water may be from 
the presence of an antimetabolite (i.e., an antimicrobial agent) in the 
water. The bottled water standards allow for the optional addition of 
safe and suitable antimicrobial agents, and the lack of microorganisms 
may be the result of the addition or use of these agents. As defined in 
Sec. 130.3(d), ``safe and suitable'' means that the ingredient performs 
an appropriate function in the food, is used at a level no higher than 
necessary to achieve its intended purpose, and is used in conformity 
with established regulations. Bottled water containing a substance, 
such as an antimetabolite, at a level considered injurious to health is 
deemed to be adulterated under section 402(a) of the act.
    FDA disagrees that all bottled water labels need a side panel 
statement concerning infant use. Under section 201(n) of the act, in 
conjunction with section 701(a) of the act, the agency is authorized to 
require labeling if the 

[[Page 57107]]
information is a material fact with respect to consequences that may 
result from the usual and customary use of the article. Because most 
bottled water is not consumed by infants, however, and thus, infant use 
is not the usual or customary use of bottled water, in the absence of 
other relevant statements in the labeling, only a mandatory statement 
on bottled water for infant use is necessary to disclose a material 
fact under section 201(n) of the act. Therefore, the agency concludes 
that the comment has not provided sufficient grounds to require that 
all bottled water bear this statement.
    In regard to the comments stating that the labeling requirement is 
misleading, unjustified, and discriminatory to the infant water 
industry, the agency has found that this information is a material fact 
on infant water under section 201(n) of the act because the product is 
targeted for an infant subpopulation that has unique needs. 
Manufacturers are labeling their products with a special claim, and 
thus the agency is establishing a special requirement, the disclosure 
of a fact that is material in light of the claim, for the use of this 
claim.
    Finally, the agency does not agree that all bottled water intended 
for use by infants should be sterile. As already discussed under this 
comment, infants do not always require sterile products. Thus, it is 
not necessary to require that bottled infant water be sterile.
    Therefore, for the reasons discussed above, FDA concludes that the 
label statement, ``Not sterile. Use as directed by physician or by 
labeling directions for use of infant formula'' is appropriate for 
bottled water that is labeled for use in feeding infants if the product 
is not commercially sterile.
    82. Three comments stated that the agency should consider limiting 
the sodium levels of infant waters to levels lower than those 
authorized for adults. They suggested limiting sodium levels to a 
maximum of 25 mg/L.
    FDA disagrees with these comments. Sodium is an important nutrient 
for infants, and the agency has determined that it would not be prudent 
to take a regulatory approach that could cause bottlers to eliminate 
the sodium from their infant water products. However, FDA acknowledges 
that there is concern that, if sodium is consumed at high levels, 
infants may develop a taste for it that can have consequences later in 
life. The agency's infant formula regulations, in Sec. 107.100(a) (21 
CFR 107.100(a)), specify that for each 100 kilocalories of formula in 
the form prepared for consumption as directed on the container, the 
formula contain at least 20 mg, and not more than 60 mg, of sodium.
    Bottled water is generally not a significant source of sodium. Data 
on the sodium content of the U.S. water supplies were reviewed and 
discussed in the April 18, 1984, final rule on the declaration of 
sodium content (49 FR 15510 at 15524). The data revealed that 50 
percent of the water sources contain less than 3.0 mg sodium per 6 
fluid ounces (oz), and that 95 percent contain less than 17.7 mg sodium 
per 6 fluid oz. Higher sodium levels, up to 52.9 mg per 6 fluid oz, 
occur in only 5 percent of the water sources.
    Any bottled water, including bottled infant water, containing more 
than an insignificant amount of sodium (5 mg or more per 240 mL 
serving) must bear nutrition labeling that lists the number of mg of 
sodium per serving. The comment's recommended maximum level of 25 mg/L 
sodium is equivalent to 6 mg per 240 mL serving. Thus, any bottled 
water at or above the comment's recommended level will, in fact, be 
required to bear nutrition labeling.
    Therefore, the agency concludes that no maximum level for sodium is 
warranted for bottled water labeled for infants because sodium is an 
important nutrient for infants, and bottled water generally does not 
contain more than an insignificant amount of sodium. Parents concerned 
about the amount of sodium in bottled water labeled for infant use will 
be alerted to the presence of more than an insignificant amount of 
sodium through nutrition labeling.
    83. Three comments stated that the agency should consider limiting 
the nitrate levels of infant waters to levels lower than those 
authorized for adults. They suggested limiting nitrate levels to a 
maximum of 15 mg/L when expressed as nitrate (NO3-) (3.4 mg/L when 
expressed as nitrogen (N)). The comments stated that infants are 
particularly at risk from ingestion of large amounts of nitrates which, 
at high doses, can result in cases of methemoglobinemia (blue baby 
syndrome).
    In the Federal Register of December 1, 1994 (59 FR 61529) 
(hereinafter referred to as the December 1994 final rule), FDA 
established maximum levels of 10.0 ppm for nitrate (as N), 1 mg/L for 
nitrite (as N), and 10 mg/L (as N) for total nitrate and nitrite in 
bottled water (Sec. 165.110(b)(4)(iii)(A)). Bottled water exceeding 
these levels must be labeled as substandard under Sec. 165.110(c)(3). 
FDA's maximum levels are based on maximum contaminant level goals 
(MCLG's) established by EPA in the Federal Register of January 30, 1991 
(56 FR 3526). EPA based the MCLG's on the toxicity of nitrate in humans 
from the reduction of nitrate to nitrite in the human body. By reacting 
with hemoglobin, nitrite forms methemoglobin, which will not transport 
oxygen to the tissues and thus can lead to asphyxia (i.e., blue 
babies). If sufficiently severe, asphyxia can lead to death. Concern 
for adverse effects of nitrate and nitrite are primarily for infants 
and other special populations.
    Therefore, because the toxicity of nitrate and nitrite in infants 
and other special populations was considered in establishing EPA's 
MCLG's, the agency concludes that there is no basis to establish a 
separate level for bottled water intended for infant use.
4. Method of Preparation of Purified Water
    FDA did not propose to require that the method of preparation of 
purified water be stated on the label, although it stated that a 
manufacturer may include this information on the label if it desires. 
FDA requested comments from interested persons on the need to include 
this information on the label.
    84. One comment stated that the specific purification process 
should be identified on the label because the public has a right to 
know what specific treatment the water receives.
    FDA disagrees with the comment. Although the information may be 
useful for some consumers, the agency tentatively concluded in the 
proposal that there was no substantive basis on which to require that 
this information appear on the label. Under section 201(n) of the Act, 
the agency must determine, among other factors, whether the information 
is a material fact with respect to consequences that may result from 
use of the article, or in light of other representations made in the 
labeling, to require that information appear on the label. As discussed 
previously, purified water is defined compositionally, and there are no 
significant compositional differences among purified waters prepared 
through the different methods. Therefore, FDA finds that the comment 
has not provided an appropriate basis to justify a requirement that the 
specific purification process appear on the label, and it is not 
requiring that the method of preparation be stated on the label of 
purified water. However, a manufacturer may include this information on 
the label if it so desires.
5. Other Labeling
    85. One comment asked that FDA reconsider IBWA's requested 
provision that any bottler whose corporate name, brand name, or 
trademark contains the 

[[Page 57108]]
words ``spring,'' ``well,'' ``artesian,'' ``mineral,'' or any other 
derivation should be required to label each bottle with the type of 
bottled product in typeface at least equal to the size of the typeface 
of the corporate name, brand name, or trademark if the type of bottled 
water differs from that implied in the corporate name, brand name, or 
trademark. It stated that this requirement may eliminate some of the 
misconceptions consumers have about bottled water products on which the 
term ``spring water'' appears as part of the corporate name.
    Another comment expressed concern about labels that use trade names 
or registered and unregistered trademarks on water that imply a 
geographic origin that is different from the actual source of the 
water.
    The agency agrees that the use of certain corporate names, brand 
names, and trademarks may be misleading to consumers if the source of 
the water is different from the source stated or implied. Section 
403(a) of the Act specifically states that a food shall be deemed to be 
misbranded if its labeling is false or misleading in any particular. 
Thus, the use of terms or vignettes that state or imply that the source 
of the water is different than the actual source would misbrand the 
food. In addition, section 403(f) of the Act states that a food is 
misbranded if any word, statement, or other information required by or 
under authority of the Act to appear on the label or labeling is not 
prominently placed thereon with such conspicuousness (as compared with 
other words, statements, designs, or devices in the labeling) and in 
such terms as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use. 
Thus, if required labeling describing the water is not appropriately 
conspicuous in relation to other label representations, the product is 
misbranded. Therefore, the agency concludes that it already has the 
authority to charge misbranding under the Act in the situations 
discussed by the comments, and that a specific regulation is not 
necessary. With the establishment of the standard of identity in 
Sec. 165.110(a), FDA now has particular definitions of bottled water 
sources that will assist the agency in enforcing these misbranding 
provisions of the Act.
    86. One comment stated that water can support the growth of 
bacteria, and that opening the bottle and pouring out the water exposes 
the remaining water to air and can constitute an ``inoculation'' with 
environmental bacteria. It stated that few consumers are aware that 
water is a suitable growth medium for bacteria, and that FDA may 
consider the advisability of a storage statement, such as ``refrigerate 
after opening,'' in the usage instructions for bottled water.
    The agency does not agree that such labeling is necessary, although 
it would not object to manufacturers voluntarily including a statement 
such as ``refrigerate after opening'' on the label. The agency has 
established a microbiological quality standard in Sec. 165.110(b)(2). 
In the Federal Register of October 6, 1993 (58 FR 52042), FDA proposed 
to amend the microbiological quality provision to require that bottled 
water be free of coliform bacteria. The agency expects to issue a final 
rule in that proceeding soon. Also in the October 6, 1993 proposal, FDA 
requested comments on other matters concerning the microbiological 
quality of bottled water. The agency will address these issues as 
appropriate.
    FDA acknowledges that some bacteria can grow in bottled water, and 
that bottled water, unless treated in some manner, is not sterile. 
Innocuous bacteria are generally already present before the consumer's 
first use. Additional bacteria may enter a bottle of water with 
exposure to the air. However, the growth of bacteria is limited in 
bottled water because it is not a good source of nutrients for most 
microorganisms.
    Therefore, the agency is not convinced that a statement such as 
``refrigerate after opening'' is necessary on bottled water because 
water is not a good growth medium for microorganisms, and because the 
agency has already addressed microbiological standards in its quality 
standard.

III. Standard of Quality

    FDA proposed to move the definition for bottled water from 
Sec. 103.35(a)(1) to Sec. 165.110(a)(1) and the standard of quality for 
bottled water from Sec. 103.35 to Sec. 165.110. The agency also 
proposed to include existing definitions for ``lot,'' ``sample,'' and 
``analytical unit'' found in Sec. 103.3 in part 165. Because FDA was 
proposing to remove the quality standard from Sec. 103.35 and include 
it in Sec. 165.110, FDA tentatively concluded that the definition of 
these terms should be moved as well.
    87. One comment objected to a provision in Sec. 165.3(b) that 
states that ``a sample consists of 10 subsamples (consumer units)'' 
because this amount of testing is too costly. It stated that a better 
procedure would be to analyze at least one sample for coliforms and 
heterotrophic plate count for each size of container and each type of 
product from one lot.
    This comment falls outside the scope of this rulemaking. The agency 
did not propose to amend the current definitions but only to move these 
definitions to be in proximity with the bottled water standard in part 
165. Therefore, FDA is not modifying the general definitions at this 
time. However, persons interested in an amendment of the definitions 
for ``lot,'' ``sample,'' and ``analytical unit'' may petition the 
agency, providing recommended definitions and justification for the 
recommendations.

A. Exemptions for Mineral Water

    The agency tentatively concluded in the January 1993, proposal that 
certain aesthetically based allowable levels should not apply to waters 
with more than 500 ppm TDS. Accordingly, the agency proposed to add a 
footnote to the list of allowable levels in Sec. 165.110(b)(4)(i)(A) to 
provide that when water is labeled as ``mineral water,'' it will be 
exempt from the allowable levels for color, odor, TDS, chloride, iron, 
manganese, sulfate, and zinc. However, FDA did not propose to include 
bottled waters that are not conspicuously identified with the term 
``mineral'' or that are identified as ``mineral water, low mineral 
content'' in this exemption because consumers will not generally expect 
to encounter flavors affected by high mineral content in these bottled 
water products. In addition, the agency did not propose to exempt 
mineral water from the allowable levels for copper, fluoride, silver, 
and turbidity. The agency requested comment concerning the need to 
establish a separate turbidity level for mineral water.
    The agency stated in the January 1993, proposal that, if it 
established an allowable level for aluminum, it would propose to exempt 
mineral water (except low-mineral-content type mineral waters) from 
that standard because the standard is intended to control the aesthetic 
properties of the water (turbidity) and not its effect on the body. In 
the December 1994 final rule, the agency established an allowable level 
of 0.2 mg/L for aluminum in bottled water. In a proposal published 
elsewhere in this issue of the Federal Register, the agency is 
proposing to exempt mineral water from the allowable level for 
aluminum.
    88. Three comments stated that mineral water should be subject to 
all of the same regulations (including the TDS maximum allowable level) 
as bottled water with no exceptions. However, the comments provided 
nothing to support this position. 

[[Page 57109]]

    The agency disagrees with these comments. For the most part, 
mineral water is subject to the same requirements as bottled water. FDA 
is only exempting mineral water that contains more than 500 ppm TDS 
from the maximum level requirements for chloride, iron, manganese, 
sulfate, zinc, and total dissolved solids in Sec. 165.110(b)(4) (see 
footnote 1 to Sec. 165.110(b)(4)(i)(A)). The agency established these 
maximum levels based on aesthetic factors and not health or safety 
factors (27 FR 2152, March 6, 1962). Most mineral waters exceed the 
quality requirement of 500 mg/L for total dissolved solids because they 
contain higher levels of these minerals than other types of bottled 
water. The comments have not provided any basis for modifying the 
exemption for mineral water, only the general request that the agency 
do so. Given the nature of mineral water, and the fact that the 
exemption it is granting only has aesthetic significance, FDA finds no 
reason to make a change in Sec. 165.110(b)(4) in response to these 
comments.
    89. Several comments supported the proposed exemption from 
secondary aesthetic-based maximum limits in the case of mineral water. 
However, they urged the agency not to limit the exemption only to 
mineral waters containing more than 500 mg/L. They requested that all 
mineral waters, regardless of their TDS content, be exempt from the 
secondary aesthetic-based maximum limits. The comments stated that 
given that there is no consumer safety concern for these secondary 
maximum levels, there is no reason to limit the exemption to mineral 
waters with a TDS above 500 mg/L. One comment noted that a mineral 
water with 490 ppm TDS, 0.4 mg/L iron, and 0.08 mg/L manganese and a 
mineral water with the same iron and manganese content but with 510 ppm 
TDS would be identical from an analytical perspective, but one would be 
substandard, and the other would not.
    In the January 1993 proposal (58 FR 393 at 401), FDA stated that it 
did not include bottled waters that are not conspicuously identified 
with the term ``mineral,'' or that are identified as ``mineral water, 
low mineral content,'' in the exemption because consumers will not 
generally expect to encounter flavors affected by high mineral content 
in these bottled water products.
    The agency agrees that there are no consumer safety concerns for 
these secondary maximum levels. The exemption from the quality standard 
for mineral water is based on allowable levels that were established 
for aesthetic reasons and not for consumer safety. The allowable levels 
from which mineral water is exempted are color and odor (physical 
quality) and chloride, iron, manganese, sulfate, total dissolved 
solids, and zinc (chemical quality). Water containing less than 500 ppm 
TDS will not exceed the allowable levels for chloride, sulfate, or 
total dissolved solids because of the high allowable levels in the 
standard. In addition, it is unlikely that water containing less than 
500 ppm TDS would exceed the allowable levels from which mineral water 
is exempted.
    The agency must consider whether consumers would expect products 
labeled as ``mineral water, low mineral content'' to contain 
objectionable aesthetic characteristics. Clearly, consumer expectations 
exist that products labeled as ``mineral water'' may contain unique 
aesthetic characteristics (Ref. 21). Because products containing less 
than 500 ppm TDS are labeled as ``mineral water,'' FDA finds that 
consumers will be informed that the product may contain objectionable 
aesthetic characteristics. Therefore, FDA concludes that the exception 
should also apply to ``mineral water, low mineral content.'' FDA is 
modifying the footnote to Sec. 165.110(b)(3) and 
Sec. 165.110(b)(4)(i)(A) to include all mineral water, including that 
containing less than 500 ppm TDS.
    90. Some comments stated that it might be appropriate for the 
agency to clarify in the text of the regulation that the standards for 
which an exemption is provided for mineral water are aesthetically 
based and do not relate to a health concern.
    FDA agrees that the exemptions from the allowable levels in the 
standard are for those that are based on EPA secondary maximum 
contaminant levels (SMCL's), which were established for aesthetic 
reasons and not for health or safety reasons, although the agency is 
not exempting mineral water from all of the allowable levels based on 
EPA's SMCL's. FDA finds that the requested modification in the footnote 
of the regulation would clarify the intent of the exemption. Therefore, 
the agency is modifying the footnote to Sec. 165.110(b) to state that 
the exemptions are aesthetically based allowable levels and do not 
relate to a health concern.
    91. Some comments urged the agency to exert caution concerning 
certain harmless, naturally occurring minerals that the agency 
characterizes as possibly causing negative aesthetic effects. They 
urged the agency to consider the rate of consumption by consumers of 
mineral waters containing these compounds before making any final 
decision.
    The agency assures the commenters that, as it considers how EPA's 
SMCL's should apply to bottled water and to mineral water in 
particular, FDA has evaluated, and will continue to evaluate, whether 
the aesthetic effect of the substance will be of concern to consumers. 
This evaluation includes a consideration of the rate of consumption of 
mineral water. The agency is exempting mineral water from some but not 
all allowable levels that are based on EPA's SMCL's. As FDA explained 
in response to the previous comment, FDA has formulated the quality 
standards to protect consumers from any adverse effects on the body, 
even those that may be characterized as aesthetic.
    92. One comment recommended that FDA reexamine the allowable levels 
for fluoride in the case of carbonated mineral water packaged in bottle 
sizes of 1.5 L or less because consumers will not use products packaged 
in these types of containers as a tap water alternative, and there will 
be a much lower average daily intake of these products. The comment 
stated that it would promote fairness towards existing mineral water 
bottlers by setting standards in a manner that is the same as that used 
for other food products. It suggested that the maximum allowable 
concentration of fluoride be no greater than 3.0 ppm for carbonated 
mineral waters, where the TDS is between 500 and 1000 ppm, and up to 
6.0 ppm where the TDS is above 1000 ppm.
    Another comment recommended that FDA set the fluoride limit for 
bottled waters at 2 ppm. The comment said that this limit is a feasible 
one for mineral water producers to meet. As an alternative, based on 
the theory that children rarely consume much of the high-mineral waters 
that are likely to have a high fluoride level, the comment suggested 
that FDA permit a fluoride content of more than 2 ppm in mineral 
waters, provided that the label bear this prominent warning: ``Not 
recommended for use by children; fluoride content can contribute to a 
significant risk of dental mottling.''
    FDA disagrees that mineral water should be exempt from the maximum 
levels for fluoride for bottled water. Although mineral water may not 
be consumed in as great a quantity as other types of water, consumers 
may obtain fluoride from other sources, and thus, mineral water can 
contribute to excessive total consumption of this mineral.
    The agency notes that the quality standard sets forth maximum 
levels for fluoride. FDA proposed a revised allowable level for 
fluoride of 2.0 ppm 

[[Page 57110]]
for naturally occurring fluoride in bottled water (53 FR 36063 at 
36067, September 16, 1988). The agency will be proceeding with that 
rulemaking now that EPA has published a notice of intent not to revise 
its fluoride drinking water standards (58 FR 68826, December 29, 1993). 
The label of bottled water, including mineral water, containing 
fluoride at levels greater than the maximum allowable levels of 
fluoride in Sec. 165.110(b)(4)(ii) must bear the statement ``contains 
excessive fluoride'' in accordance with Sec. 165.110(c)(3).
    93. One comment stated that, if in the final rule FDA allows an 
exemption for sulfate in mineral water containing more than 500 ppm 
TDS, FDA should require that all bottled water containing sulfates 
display labels with language similar to the following: ``Warning, this 
product may contain high levels of sulfate which may cause diarrhea in 
sensitive population groups including infants, children, and pregnant 
women.'' It stated that this statement should be a minimum requirement 
because there is evidence that sensitive population groups are 
susceptible to harmful effects from products that contain sulfates.
    The agency notes that in the Federal Register of December 20, 1994 
(59 FR 65578), EPA proposed a MCLG and a National Primary Drinking 
Water Regulation (NPDWR) including a MCL of 500 ppm TDS for sulfate. 
EPA stated that sulfate is a unique contaminant because the health 
effect associated with the ingestion of relatively high levels of 
sulfate in drinking water (i.e., ranging from loose stools to diarrhea) 
is acute and temporary and is expected to last approximately 2 weeks. 
In addition, EPA stated that the health risk only applies to persons 
not already acclimated to high sulfate-containing water--infants, 
travelers, and new residents. EPA did not propose to amend the SMCL of 
250 mg/L for sulfate that is based on aesthetic effects (i.e., taste 
and odor).
    In the Memorandum of Understanding (MOU) concerning the control of 
drinking water, EPA and FDA agreed that the authority to control 
substances in drinking water should be vested with EPA to avoid 
duplicative and inconsistent regulation. Therefore, FDA is not 
establishing a maximum allowable level for sulfate in mineral water at 
this time. However, if EPA establishes an MCL for sulfate in public 
drinking water, in accordance with section 410 of the act (21 U.S.C. 
349), FDA will consider amending the bottled water quality standard to 
establish a maximum allowable level for sulfate in mineral water.
    The agency is exempting mineral water from the allowable level for 
sulfate of 250 ppm at this time because some mineral waters exceed this 
aesthetically determined level without causing any adverse effects 
(Ref. 22). However, if mineral water contains sulfate, or any other 
substance, at a level that is injurious to health, it is deemed to be 
adulterated and subject to regulatory action.
    94. One comment stated that under the January 1993 proposal, 
bacteriologically and chemically pure artesian or mineral water, for 
example, that is safe for consumers would have to bear the label 
statement ``abnormal color and smell,'' even if the ``abnormal'' color 
and smell results from perfectly normal, naturally occurring dyes and 
gasses that are constituent to its source. The comment contended that 
these substances make the water unique by their individual combination 
and are often sought or favored by consumers, both domestically and 
internationally. It stated that the designation ``abnormal'' on 
unadulterated, uncontaminated water is an inappropriate requirement for 
labeling. It stated that it is especially inappropriate when the source 
waters are unique, identified as to their source, and otherwise pure, 
natural, and uncontaminated.
    FDA established the physical quality standards concerning color and 
odor based on EPA SMCL's. These allowable levels were established for 
aesthetic reasons and not to ensure consumer safety. The primary 
purpose of a quality standard is to establish the minimum acceptable 
quality criteria for a product when it is offered to consumers. The 
quality standard for bottled water is based on the normal range of 
waters, and a consumer's expectation is also based on the normal range 
of waters. Thus, the label needs to respond to that expectation and not 
be tailored to individual situations. Because bottled water that does 
not meet the color and odor quality standard may be objectionable to 
consumers, the labeling requirements established in the standard 
continue to be appropriate for bottled water in general.
    Therefore, bottled water (e.g., artesian water) that is not 
exempted from the quality standard and that exceeds the maximum 
allowable levels for color or odor must bear the label statements 
``Abnormal Color'' or ``Abnormal Odor'' as required by 
Sec. 165.110(c)(2). However, the agency points out that in the case of 
mineral water, products that do not meet the color and odor quality 
standard are exempted from the standard.

B. Substandard Chemical Quality Labeling

    In the January 1993 proposal, FDA tentatively concluded that the 
general phrase, ``Contains Excessive Chemical Substances,'' may not be 
adequate for mineral water and proposed that the label or labeling of 
mineral water list the specific names of any substances present in 
amounts that exceed the allowable levels to which mineral water is 
subject (e.g., ``Contains Excessive Fluoride,'' ``Contains Excessive 
Trihalomethanes'').
    95. Two comments objected to allowing bottlers to distribute a 
product that does not meet the water quality standards. One comment 
stated that the purpose of water quality standards is to prevent 
products that are below acceptable standards from being distributed to 
consumers. It noted that given the emphasis by the bottled water 
industry on the quality of bottled water versus tap water, it is quite 
doubtful that bottlers would print any substandard notice on the 
product label. Another comment questioned whether consumers would be 
able to interpret the significance of the phrase ``contains excessive 
chemical substances'' on a label. It requested that FDA require at a 
minimum that the specific chemical substances be listed similar to 
FDA's proposal for substandard mineral water.
    One comment questioned whether bottled water exceeding the 
microbiological standards should be sold at all, regardless of how it 
is labeled.
    FDA notes that under section 403(h)(1) of the act, a food is deemed 
to be misbranded if it is a food for which a standard of quality has 
been prescribed by regulation, and its quality falls below such 
standard, unless its label bears, in such manner and form as such 
regulations specify, a statement that it falls below such standard. 
Bottled water may be sold even though it contains a substance at a 
level that exceeds the maximum allowable levels in the quality standard 
so long as that substance does not adulterate the food under section 
402 of the act. However, the agency points out that most of the maximum 
allowable levels in the bottled water quality standard are identical to 
EPA MCL's, and EPA establishes its levels based on health 
considerations. Therefore, many substances, including microorganisms 
(e.g., coliforms), present in amounts exceeding FDA's maximum allowable 
levels could be present at levels that are injurious to health. 

[[Page 57111]]

    The agency disagrees with the request that it require, at a 
minimum, that the specific chemical substances that exceed the maximum 
allowable levels in Sec. 165.110(b)(4) to be listed on the label 
instead of providing the exception in Sec. 165.110(c)(3) if the bottled 
water is not mineral water. The chemical content of mineral waters 
generally exceeds one or more allowable levels in the bottled water 
standard, and thus, consumers would expect mineral water to normally 
contain excessive chemicals. As discussed above, the agency has 
exempted mineral water from certain allowable levels in the quality 
standard on this basis. Consumers would not expect bottled water that 
is not mineral water to contain any excessive chemicals because the 
quality standard is based on the normal range of waters.
    Therefore, the agency concludes that the statement ``contains 
excess chemical substances'' is appropriate for bottled water other 
than mineral water, and that it is not necessary to require more 
specific labeling because consumers will be alerted to the presence of 
chemical substances in amounts that exceed the maximum allowable 
levels. However, the agency does not object to the labeling of bottled 
water that declares the substandard presence of specific chemicals in 
lieu of the more general statement ``contains excess chemical 
substances.''
    FDA notes that it has made a number of editorial modifications in 
Sec. 165.110(c), including deleting and renumbering several of the 
provisions that appeared in the proposal, for clarity.

IV. Current Good Manufacturing Practices

A. Product Water, Operations Water, and Compliance Procedures

    On January 5, 1993, the agency proposed to update the references in 
Sec. 129.35 and to delete the exclusion for mineral water from testing 
requirements in Sec. 129.80(g). FDA also proposed to permit firms that 
use a municipal water system as the source of their water to substitute 
municipal testing results showing full compliance with the EPA primary 
and secondary drinking water regulations (or a certificate to this 
effect) for the source water chemical contaminant testing required in 
Sec. 129.35(a)(3). In addition, the agency proposed to permit firms 
that use a nonmunicipal water source as the source of their water to 
reduce the frequency of testing and the number of chemical contaminants 
for which they test source water if they can document that such 
reduction is consistent with a waiver that the State has issued under 
EPA regulations (Sec. 129.35(a)(4)(ii)).
    96. Several comments suggested that FDA use the term ``public water 
supply'' as defined by EPA rather than use the term ``municipal 
supply.'' (See previous discussion in comment 72.)
    The agency notes that it used the term ``municipal water system'' 
in proposed source water testing exemptions in Sec. 129.35(a)(4) (58 FR 
393 at 407). However, FDA agrees that in the context of this section, 
the term ``public water system'' is more appropriate because it 
includes water that is covered by EPA's drinking water regulations and 
State programs established under EPA programs. The intent of FDA's 
testing exemptions was to apply to water based on whether or not the 
source was a public water system. Therefore, the agency is modifying 
Sec. 129.35(a)(4)(i) to include firms that use a public water system 
for source water and Sec. 129.35(a)(4)(ii) to include firms that do not 
use a public water system.
    97. One comment requested that all types of nonmunicipal sources 
maintain documentation on file that establishes that the source has 
been evaluated and determined to meet the design, operation, and 
maintenance requirements of the government agency having jurisdiction.
    The agency advises that firms must have source approval of their 
product water and must maintain records of the source approval. 
According to Sec. 129.3(a), an ``approved source,'' when used in 
reference to a plant's product water or operations water, means a 
source of water and the water therefrom, whether it be from a spring, 
artesian well, drilled well, municipal water supply, or any other 
source, that has been inspected, and the water sampled, analyzed, and 
found to be of a safe and sanitary quality, according to the applicable 
laws and regulations of the State and local government agencies having 
jurisdiction. The presence in the plant of current certificates or 
notifications of approval from the government agency or agencies having 
jurisdiction constitutes approval of the source and the water supply. 
Therefore, no action is necessary in response to the comment.
    98. Comments stated that no standards are set to protect a well or 
spring and its recharge area against the intrusion of contaminants. One 
comment stated that there should be very strict rules governing 
ownership, control, and protection of the recharge area of any well or 
spring.
    FDA agrees that the recharge area of any well or spring is a 
critical area. However, the agency disagrees that it is necessary to 
establish requirements concerning ownership, control, and protection of 
the recharge area of any well or spring because it has already 
established requirements in parts 129 and 165 to guard against the 
presence of contaminants in bottled water, whether from the recharge 
area or any other source of contamination.
    First of all, the source of the water must be an approved source, 
and the water found to be of a safe and sanitary quality by the 
government agency approving the source (Sec. 129.35(a)). Such source 
approval could include the source of recharge to determine whether the 
water will be of a safe and sanitary quality.
    In addition to meeting the requirements of part 129, bottled water 
must meet the requirements of the quality standard in Sec. 165.110(b) 
or be labeled as substandard in accordance with Sec. 165.110(c). The 
quality standard lists allowable levels for many common contaminants of 
recharge areas (e.g., pesticides and nitrates).
    Finally, as stated in Sec. 165.110(d), bottled water containing a 
substance at a level considered injurious to health under section 
402(a)(1) of the act is deemed to be adulterated, regardless of whether 
or not the water bears a label statement of substandard quality. 
Therefore, the agency concludes that consumers are protected against 
problems that may occur in the recharge area of a spring or well used 
as a source for any bottled water product.
    99. One comment stated that any water under the influence of 
surface water must be treated as surface water and should never be 
called ``spring water,'' ``well water,'' or ``natural water,'' 
regardless of whether it was collected from a spring or pumped from a 
well.
    Another comment stated that, in general, the microbiological 
standards in the proposed regulation are weak and do not address the 
issue of ground water under the influence of surface water. The comment 
urged FDA to incorporate appropriate source approval standards similar 
to those of the State of North Carolina as a means to ensure safe 
bottled spring and well waters.
    One comment requested that FDA state that spring water must not be 
under the direct influence of surface water. The comment stated that a 
requirement, such as an initial water particulate test during the rainy 
season, should be considered for spring water.
    The agency agrees that any water under the direct influence of 
surface water is not ground water, regardless of whether it was 
collected from a spring or pumped from a well. EPA defines 

[[Page 57112]]
``ground water under the direct influence of surface water'' in 40 CFR 
141.2 as any water beneath the surface of the ground with significant 
occurrence of insects or other macroorganisms, algae, or large diameter 
pathogens such as Giardia lamblia, or significant and relatively rapid 
shifts in water characteristics such as turbidity, temperature, 
conductivity, or pH which closely correlates to climatological or 
surface water conditions. The manifestation of any of these factors 
evidences that the source is under the direct influence of surface 
water and is, therefore, not a ground water source. The definitions of 
``spring water,'' ``artesian water,'' ``mineral water,'' and ``well 
water'' that FDA is adopting in this document require that the source 
be a ground water source.
    EPA has published a Consensus Method for Determining Groundwaters 
Under the Direct Influence of Surface Water Using Microscopic 
Particulate Analysis (MPA) (Ref. 23). The consensus method is the 
result of a collaborative effort combining the experiences and 
knowledge of contributors from around the country into an acceptable 
consensus method. This guidance may be used to determine whether ground 
water is under the direct influence of surface water. This 
determination may be considered as part of the source approval 
conducted by the State or local agency having jurisdiction because, 
under Sec. 129.3(a), source water must be found to be of a safe and 
sanitary quality.
    FDA adds that it published a proposal, to amend the quality 
standard for bottled water to require that bottled water be free of 
coliform bacteria (58 FR 52042). In that proposed rule, FDA also 
addressed other matters concerning the microbiological quality of 
bottled water and requested comments on whether the agency should 
establish quality standard regulations for other microorganisms that 
may be present in bottled water and pose a health hazard. The agency 
will discuss the comments that it received in response to that proposal 
in that rulemaking.
    100. One comment recommended added testing for bacteriological 
contaminants, trihalomethanes, lead, and copper in those situations 
where the bottled water manufacturers will be permitted to substitute 
municipal test results for the testing requirements of 
Sec. 129.35(a)(3). It stated that additional testing is necessary for 
these contaminants because of contamination that could occur in the 
water distribution system.
    One comment stated that allowing bottled water producers that use a 
municipal water source to substitute municipal testing results for the 
source testing requirements is reasonable only if the final product 
testing requirements are retained.
    FDA disagrees that it should require additional testing by bottled 
water manufacturers who substitute public water system test results for 
source water testing. However, the agency agrees with the comment that 
stated that the substitution of public water system test results for 
source water testing is appropriate only if the final product is tested 
according to the requirements in Sec. 129.80(g). The testing exemptions 
for microbiological contaminants that FDA established previously 
(Sec. 129.35(a)(3)(i)) and for chemical contaminants that FDA is 
establishing in this rulemaking (Sec. 129.35(a)(4)(i)) apply to the 
source water testing requirement only. Part 129 also requires testing 
of product water (i.e., after processing but prior to packaging) and 
finished product. Under Sec. 129.80(a), product water samples must be 
taken after processing and before bottling by the plant and analyzed as 
often as is necessary to ensure uniformity and the effectiveness of the 
processes performed by the plant. In addition, under Sec. 129.80(g)(1) 
and (g)(2), a bottled water plant must analyze a representative sample 
of the finished product of each type of bottled drinking water at least 
once a week for the presence of bacteria and at least annually for 
chemical contaminants.
    The agency concludes that no additional chemical or microbiological 
testing requirements are necessary for bottled water manufacturers who 
use public water systems and who substitute testing results from the 
public water system for source water testing requirements in part 129 
because FDA requires that product water and finished product water be 
regularly tested, and if any contaminant is contributed by the water 
distribution system it will be detected by the required testing. The 
testing requirements in Sec. 129.80 have functioned satisfactorily 
since FDA adopted them in 1979 (44 FR 12173, March 6, 1979), and the 
agency finds no reason to amend them. FDA points out that its adoption 
of the source water testing exemptions in Sec. 129.35(a)(4) in no way 
changes how product water and finished product water are to be tested.
    101. Two comments objected to Sec. 129.35(a)(4)(ii) regarding a 
waiver for nonmunicipal water used by firms for the purposes of 
manufacturing bottled water. They stated that under proposed 
Sec. 129.35(a)(4)(ii), a firm could reduce the number of contaminants 
for which it tests, and the frequency with which it performs testing, 
if it can document that such reduction is consistent with a waiver that 
the State has issued under EPA regulations. The comments stated that 
FDA should not allow a manufacturer to establish that such a waiver 
exists but should require the governmental entity regulating the source 
to make such a determination.
    The agency disagrees with the comments. Firms may reduce the 
frequency of testing and the number of chemical contaminants for which 
they test source water if they can document that such reduction is 
consistent with a State-issued waiver under EPA regulations for public 
water systems. State waivers may either eliminate the requirement for a 
3-year compliance period (e.g., pesticides/polychlorinated biphenyl's 
(PCB's)) or reduce the frequency of testing (e.g., inorganics and 
volatile organic chemicals). Waivers are either based on a review of 
established criteria (``a waiver by rule'') or on a vulnerability 
assessment. In the Federal Register of January 30, 1991 (56 FR 3526 at 
3562), EPA discussed the criteria for waivers by ``rule'' and 
``vulnerability assessment.''
    EPA may rescind waivers issued by a State where EPA determines that 
the State has issued a significant number of inappropriate waivers. If 
a waiver is rescinded, the firm must monitor in accordance with the 
requirements in Sec. 129.35.
    States develop their own specific vulnerability assessment 
procedures that use the general guidelines established by EPA. If a 
State chooses not to develop these procedures, firms cannot receive 
waivers and must monitor the source water in accordance with 
Sec. 129.35.
    Therefore, firms cannot decrease the amount of testing that they 
perform unless the State has issued a waiver to them. The presence of a 
current State-issued document in the plant will certify that testing of 
source water may be reduced. The reduction in testing is only for those 
contaminants covered by the waiver. If the State has not issued such a 
waiver, the firm must annually test for all contaminants.
    FDA points out that the State-issued waiver from chemical testing 
requirements in Sec. 129.35(a)(4) applies only to source water testing, 
and that the product water must be tested in accordance with 
Sec. 129.80(a). Moreover, the finished product must be tested for all 
substances in accordance with Sec. 129.80(g). Thus, FDA concludes that 
no modification of Sec. 129.35(a)(4)(ii) is warranted.
    102. One comment recommended that Sec. 129.35(a)(4)(ii) be modified 
to require that at least two complete samples for 

[[Page 57113]]
all contaminants be made before any reduction in testing is allowed, 
even when the State has issued a waiver. It stated that there can be 
great variation in contaminant levels in both surface and ground water 
sources, even with withdrawal points that are in close proximity. The 
comment claimed that a requirement for initial sampling is the only way 
to ensure that waivers are appropriate, and that, where firms make use 
of this testing exception, they should be required to maintain the data 
from initial sampling and support documentation on State waivers 
indefinitely rather than for the 2-year period typically required for 
test data.
    The agency disagrees with the comment. As EPA explained in the 
Federal Register of January 30, 1991 (56 FR 3526 at 3562), waivers are 
granted on a contaminant-by-contaminant basis. Waivers for pesticides/
PCB's and volatile organic chemicals (VOC's) may be granted after the 
firm conducts a vulnerability assessment, and the State determines that 
the source is not vulnerable based on that assessment. A waiver must be 
renewed every 3 years (id.). Waivers for inorganic contaminants (except 
nitrate/nitrite) may be granted for up to 9 years. If a firm does not 
receive a waiver, it must comply with the requirements in Sec. 129.35.
    The vulnerability assessment is based on a two-step waiver 
procedure. Step 1 determines whether the contaminant was used, 
manufactured, stored, transported, or disposed of in the area. In the 
case of some contaminants, an assessment of the contaminant's use in 
the treatment or distribution of water may also be required. ``Area'' 
is defined as the watershed area for a surface water system or the zone 
of influence for a ground water system and includes effects in the 
distribution system. If the State determines that the contaminant was 
not used, manufactured, stored, transported, or disposed of in the 
area, then the system may obtain a ``use'' waiver. Systems receiving a 
``use'' waiver are not required to continue on to Step 2 to determine 
susceptibility. EPA anticipated that most ``use'' waivers will be for 
pesticides/PCB's, the use of which can be determined more easily than 
for VOC's. Obtaining a use waiver for the VOC's will be limited because 
VOC's are ubiquitous in the United States (56 FR 3526 at 3562).
    If a use waiver cannot be given, that is, if the State cannot make 
a determination that the contaminant was not used, manufactured, 
stored, transported, or disposed of in the area, a system may conduct 
an assessment to determine susceptibility (Step 2). Susceptibility 
considers prior occurrence or vulnerability assessment results, 
environmental persistence and transport of the chemical, the extent of 
source protection, and EPA Wellhead Protection Program reports. Systems 
with no known ``susceptibility'' to contamination based upon an 
assessment of the above criteria may be granted a waiver by the State. 
If ``susceptibility'' cannot be determined, a system is not eligible 
for a waiver (56 FR 3526 at 3563).
    EPA also established guidelines for decreased monitoring of 
inorganic chemicals (56 FR 3526 at 3564). States may decide, based on 
prior analytical results, variation in analytical results, and system 
changes such as pumping rates or stream flows/characteristics, to allow 
firms to reduce the monitoring frequency to no less than 9 years. To 
qualify for this waiver, at a minimum, three previous compliance 
samples must have been reliably and consistently less than the MCL.
    The above minimum guidelines, along with any additional State 
requirements, provide adequate consumer protection because a firm must 
perform appropriate testing before a waiver will be issued. In 
addition, the use or susceptibility requirements of the program provide 
assurances that a contaminant is not present in the area. Finally, the 
waiver does not extend to testing of the product water and the finished 
product. Thus, FDA concludes that the requirements for obtaining the 
waiver adequately address consumer safety concerns.
    Firms must document that they have a current State-issued waiver, 
and that the waiver complies with State requirements even though the 
waiver may have been issued prior to the 2-year record retention time 
period required by Sec. 129.80(h). Records of the waiver must be 
retained for not less than 2 years after the waiver expires to meet the 
requirements of Sec. 129.80(h). This retention requirement ensures that 
all testing records, exemptions from testing, and source approval 
requirements are documented for the same production batch of bottled 
water. However, the agency sees no need for manufacturers to maintain 
these records indefinitely, and the comment has not provided grounds 
for such a requirement.
    103. One comment asked whether FDA is requiring the same sampling 
frequency as is required for public systems under EPA's Phase II rules 
(56 FR 3526) by including the waiver process in this regulation. The 
comment stated that, for example, inorganics could be tested at a 
frequency of once every 9 years according to EPA regulations. It asked 
whether FDA feels that such a frequency of testing provides adequate 
protection of source water.
    The agency notes that manufacturers must comply with all the source 
testing requirements in Sec. 129.35(a)(3) unless they have received a 
State-issued waiver for specific contaminants. As discussed above, 
under EPA's Phase II rules (56 FR 3526), States may issue waivers only 
if circumstances affecting the source and the area surrounding the 
source make it unlikely that the contaminant will be present. Based on 
its review of the evidence on these factors, the State may issue a 
waiver decreasing the frequency of testing from 3 to 9 years depending 
on the contaminant.
    FDA believes that the use of a State-issued waiver is an 
appropriate substitute for source water testing because a State must 
require that the water be tested before issuing the waiver, and that 
the conditions relevant to the occurrence of the contaminant confirm 
that it is unlikely that the contaminant will be present. Again, FDA 
affirms that the finished bottled water must be tested at least 
annually for chemical contaminants and comply with FDA regulations.
    104. One comment stated that, because the source has no bearing on 
the final product for purified or distilled water, there was reason to 
question whether it was necessary for a bottler that bottles only 
purified water to have annual chemical and radiological tests of its 
source water.
    FDA disagrees with the comment. Source testing is important to 
ensure the purity of the source water. The source water must be of 
reasonable quality to ensure that the finished product complies with 
the quality requirements. If a source contains excessively high levels 
of some contaminants, these contaminants may not be adequately removed 
in the purification process. Therefore, the agency concludes that the 
source water for purified water should not be exempt from all the 
requirements of part 129. However, the agency notes that there are 
source water testing exemptions in Sec. 129.35(a)(4) that may apply to 
the source water for purified water. If applicable, these exemptions 
could replace or reduce the source testing requirements for chemical 
contaminants.
    105. One comment expressed concern about FDA regulating the testing 
of source water if FDA would preempt State agencies from setting 
standards for source water that are equivalent to State Drinking Water 
Standards. The comment held that the State should have the authority to 
set more stringent standards for source water when there is 

[[Page 57114]]
a safety issue. It noted that water bottled in a State should have at 
least the same health-based quality standards as public drinking water 
in that State. The comment questioned whether FDA has jurisdiction over 
source water and was opposed to FDA regulating the water quality 
standards for source water, which are under the jurisdiction of the 
States or EPA.
    The agency notes that it is not amending its regulations with 
respect to the testing of source water except to provide that bottlers 
using a public water supply may substitute certificates showing 
compliance with EPA's requirements for chemical contaminants for 
testing results, and that bottlers may use a State-issued waiver for 
some chemical contaminants. Section 129.35(a)(3) specifies the 
frequency of testing of source water for chemical, radiological, and 
microbiological contaminants. This sampling is in addition to any that 
is performed by government agencies having jurisdiction. The source is 
approved by the State or local government agency having jurisdiction 
and must comply with the applicable laws of that agency, even though 
those laws are more stringent than FDA requirements. FDA has 
traditionally relied on the laws of the State or locality having 
jurisdiction. Therefore, FDA concludes that there is no basis for the 
concern expressed by the comment.

B. Additional Definitions

    Although the agency did not propose definitions for ``bottled water 
plant,'' ``plant operator,'' or ``water dealer,'' or to revise the 
definition for ``bottled drinking water,'' as IBWA requested, FDA 
requested comment from interested persons on the need to define or 
amend the definitions of these terms.
    106. One comment recommended that FDA define ``bottled water 
plant.'' It stated that such a definition would enable States that have 
bottled water regulations to adopt a uniform definition.
    The agency has decided that it is not necessary to adopt a 
definition for ``bottled water plant.'' Part 110, concerning CGMP in 
manufacturing, packing, and holding human food, applies to bottled 
water along with part 129. Under Sec. 110.3(k), ``plant'' means the 
building or facility or parts thereof, used for or in connection with 
the manufacturing, packaging, labeling, or holding of human food. Thus, 
``bottled water plant'' can be fairly interpreted, under FDA's 
regulations, to mean the building or facility or parts thereof, used 
for or in connection with the manufacturing, packaging, labeling, or 
holding of bottled water. In its petition, IBWA defined ``bottled water 
plant'' as any place or establishment in which bottled water is 
prepared for sale. The State of California defines ``water-bottling 
plant'' as any facility in which bottled water is produced (Ref. 2). 
Thus, FDA concludes that the definition in Sec. 110.3(k) is adequate 
because it is consistent with the common definition of a bottled water 
plant, and that a specific definition for this term in part 129 is not 
necessary.

C. Unregulated Contaminants

    IBWA requested revision of part 129 to provide for additional 
source and final product testing requirements in Sec. 129.35 to detect 
and control specific unregulated contaminants. The agency did not 
propose to require such testing because firms are free to test for 
contaminants not listed in the quality standard, and they must employ 
appropriate quality control procedures to ensure that food is suitable 
for human consumption (Sec. 110.80). In addition, bottled water that 
contains a poisonous or deleterious substance is subject to regulatory 
action under the adulteration provisions of the act. Producers that 
knowingly produce and distribute adulterated bottled water may be 
subject to the criminal penalties of the act.
    107. One comment requested that FDA amend Sec. 129.35 to require 
testing of bottled water products (on at least an annual basis) for 
those substances listed in EPA's requirements for monitoring of 
unregulated contaminants. It stated that this requirement should be 
made immediately applicable to all bottled water producers.
    The agency disagrees with the comment. Under section 1445(a) of the 
SDWA, EPA was required to promulgate monitoring requirements for 
unregulated contaminants. EPA established monitoring requirements for 
51 synthetic organic chemicals in the Federal Register of July 8, 1987 
(52 FR 25690), and promulgated monitoring requirements for an 
additional 30 synthetic organic chemicals and inorganic chemicals in 
the Federal Register of January 30, 1991 (56 FR 3526), that were not 
regulated by NPDWR's to assist EPA in establishing future NPDWR's. EPA 
did not establish regulations that would set forth maximum levels of 
these contaminants, only the requirement that public water systems 
monitor for them.
    FDA does not believe that it is necessary to mandate testing for 
unregulated contaminants in bottled water because such testing is for 
EPA monitoring and information purposes only. As EPA identifies the 
need to regulate a substance from its monitoring activities, and 
subsequently adopts MCL's for them, FDA will promulgate applicable 
regulations for bottled water under section 410 of the act (21 U.S.C. 
349). The comment did not provide a basis to establish a requirement 
for additional testing. It only requested that FDA do so. Therefore, 
the agency concludes that amending Sec. 129.35 in the manner suggested 
by the comment is not warranted.
    108. One comment stated that additional final product testing 
should be required for any contaminants that can enter the water 
through the water system or through the bottles. It stated that these 
contaminants, given their low levels, may not be poisonous or 
immediately deleterious but should not be in bottled water. The comment 
stated that several years ago, a California firm used a new clear resin 
that was subsequently found to be leaching cyclohexanes, among other 
things. It stated that at least one consumer injury was reported when a 
particularly bad batch of resin was used. The comment cited another 
instance of chemicals entering the water from improperly cured new 
piping. It stated that in these instances, the required source water 
monitoring for additional contaminants would not have uncovered the 
problem in the finished product.
    FDA disagrees that it should establish additional finished product 
testing requirements for chemical contaminants derived from processing 
equipment or packaging. Substances that get into the product from 
product contact surfaces can vary from manufacturer to manufacturer and 
from lot to lot. The agency considers these substances to be indirect 
food additives. Thus, any product that contains such a substance whose 
use has not been regulated by FDA will be deemed to be adulterated 
under section 402(a)(2)(C) of the act (21 U.S.C. 342(a)(2)(C)) in that 
it contains an unsafe food additive.
    Under Sec. 129.40(a), all plant equipment and utensils must be 
suitable for their intended use. Included under the coverage of this 
section are all collection and storage tanks, piping, fittings, 
connections, bottle washers, fillers, cappers, and other equipment that 
may be used to store, handle, process, package, or transport product 
water. All product water contact surfaces must be constructed of 
nontoxic and nonabsorbent material that can be adequately cleaned and 
sanitized and that is in compliance with section 409 of the act (21 
U.S.C. 348). Furthermore, Sec. 129.80(f) requires that only nontoxic 
containers and closures be used. ``Nontoxic materials'' is 

[[Page 57115]]
defined in Sec. 129.3(e) as materials for product water contact 
surfaces, used in the transporting, processing, storing, and packaging 
of bottled drinking water, that are free of substances that may render 
the water injurious to health or that may adversely affect the flavor, 
color, odor, or bacteriological quality of the water. Therefore, the 
agency concludes that there are already adequate provisions in part 129 
to address the comment's concern, and that no modifications are 
necessary.

D. Microbiological Control Standards

    IBWA requested revision of Sec. 129.40 to include microbiological 
control standards that included prohibitions from processing and 
bottling water with equipment that has been used to produce milk, fruit 
juice, or any other food product likely to contribute nutrients for 
microbiological growth. FDA was not persuaded by the information that 
IBWA submitted that the revision was needed.
    109. A number of comments stated that FDA did not provide a 
sufficient rationale for not requiring that firms use dedicated 
equipment (i.e., equipment used solely for one product) for processing 
bottled water. One comment stated that dedicated equipment, with the 
exception of fillers, is an important precaution to maintain the 
quality of bottled water.
    One comment stated that FDA should prohibit equipment used for milk 
production from being also used for bottled water production to protect 
consumers from potential health hazards. It stated that there is a 
greater potential of microbiological contamination of bottled water if 
it is produced using equipment that is also used for milk production. 
Another comment stated that high coliform and other bacteria counts 
from either inadequate cleaning or inadequately trained personnel 
improperly maintaining or operating the equipment has been a problem 
with at least one California dairy that also bottles water.
    Several comments were concerned that FDA proposed no restriction on 
the use by water bottlers of: (1) Equipment used to transport, store, 
process, or bottle nonfood products (e.g., pesticides, toxic 
chemicals); and (2) equipment used to transport, store, process, or 
bottle food products likely to contaminate bottled water with nutrients 
for microbial growth. The comments stated that these equipment use 
restrictions are important public health safeguards.
    Conversely, other comments supported FDA's position that dedicated 
lines for bottled water should not be a requirement. The comments noted 
that only good sanitation will ensure a low probability of 
microbiological contamination. One comment stated that the rationale 
used by the agency is supportable based on the performance history of 
the dairies and soft drink manufacturers that also produce bottled 
water.
    One comment stated that certified results confirmed that bottled 
water produced by dairy plants equalled or exceeded the bacterial 
quality of that produced by dedicated water bottlers. It stated that 
all bottlers should be subject to the same quality and testing 
regulations.
    One comment from a dairy stated that a requirement for dedicated 
equipment would eliminate that dairy from the bottled water market. The 
comment stated that, because the firm is experienced in high quality 
sanitation practices from bottling fluid milk products, it is confident 
of its ability to meet regulatory product standards for consumer 
safety.
    One comment stated that, although milk, fruit juice, and other food 
processing operations should not be prohibited from processing bottled 
water, additional operational requirements should be imposed on these 
types of processing plants because of the likelihood of mineral 
deposits building up inside feed lines. The comment stated that these 
mineral deposits tend to shield bacteria and other pathogens from 
disinfection if standard disinfection practices are used.
    FDA disagrees with the comments that stated that it should require 
dedicated equipment for processing bottled water. Under Sec. 129.37(a), 
the product water-contact surfaces of all multiservice containers, 
utensils, pipes, and equipment used in the transportation, processing, 
handling, and storage of product water must be clean and adequately 
sanitized. All product water-contact surfaces must be inspected by 
plant personnel as often as necessary to maintain the sanitary 
condition of such surfaces and to ensure that they are free of scale, 
oxidation, and other residues. The presence of any unsanitary 
condition, scale, residue, or oxidation must be immediately remedied by 
adequate cleaning and sanitizing of that product water-contact surface 
before it is used again.
    Section 129.40(a)(2) requires that all product water contact 
surfaces be constructed of nontoxic and nonabsorbent material that can 
be adequately cleaned and sanitized and that is in compliance with 
section 409 of the act. Furthermore, Sec. 129.80(d) states that 
sanitizing operations must be adequate to effect sanitization of the 
intended product water-contact surfaces and any other critical area. 
Therefore, the agency concludes that there already are appropriate 
regulations in part 129 that adequately address the concerns of the 
comments.
    As FDA stated in the proposal (58 FR 393 at 403), dedicated 
equipment will not ensure that the goal of production of foods with a 
low probability of microbiological contamination will be met. Only good 
sanitation will ensure that this goal is achieved. FDA does not require 
dedicated equipment for any other food and is not persuaded that 
dedicated equipment is necessary for bottled water. Bottled water 
containing any substance considered injurious to health is adulterated 
under section 402(a)(1) of the act.
    Microbiological standards exist for bottled water in 
Sec. 165.110(b)(2). Manufacturers must ensure that bottled water meets 
the microbiological quality standards in Sec. 165.110(b)(2) or label 
the product as substandard. If the product is deemed to be adulterated, 
it cannot be sold at all.
    In the Federal Register of October 6, 1993 (58 FR 52042), the 
agency proposed to amend the quality standard to require that bottled 
water be free of coliform bacteria. In addition, FDA addressed other 
matters concerning the microbiological quality of bottled water and 
requested comments on whether it should establish quality standard 
regulations for other microorganisms that may be present in bottled 
water and may pose a health risk. The agency intends to discuss the 
comments that it received in response to that proposal in that 
rulemaking.

E. Processes and Controls

    IBWA requested revision of certain requirements in part 129 
pertaining to filtration and germicidal treatment. FDA did not propose 
the requested revisions but stated that it would consider adopting them 
in other rulemakings. As stated above, the agency has proposed to amend 
the quality standard for bottled water to require that bottled water be 
free of coliform bacteria (58 FR 52042). In that proposal, FDA also 
addressed other matters concerning the microbiological quality of 
bottled water and requested comments on whether the agency should 
establish quality standard regulations for other microorganisms that 
may be present in bottled water and may pose a health risk. The agency 
will discuss the comments that it received in response to that proposal 
in that rulemaking.
    110. Several comments urged FDA to require mandatory disinfection 
of 

[[Page 57116]]
bottled water with ozone or an equivalent disinfection process. Two 
comments stated that failure to require treatment of mineral water with 
ozone or an equivalent disinfectant process would reduce the level of 
public health protection now provided.
    However, some comments stated that bottled water need not be 
disinfected if it meets the standards of the European Economic 
Community Directive 80/777/EEC for Natural Mineral Water, July 15, 1980 
(European Community), which mandates that numerous and frequent 
microbiological analyses of the water be done to ensure its potability 
in lieu of disinfection. One comment stated that mandatory disinfection 
of mineral water that includes bottled water products covered by the 
ERCS for ``natural mineral waters'' would constitute interstate 
commerce restraints and inappropriate regulations.
    The agency does not consider it necessary at this time to require 
disinfection of bottled water. FDA acknowledges the strict standards 
for bottling water that have been adopted by the European Community and 
by other countries, and that, when water from protected sources is 
bottled under strict hygienic conditions, disinfection may not be 
necessary. However, the agency has established microbiological quality 
standards in Sec. 165.110(b)(2), and bottled water that does not comply 
with the microbiological quality standard must be labeled with a 
statement of substandard quality, in accordance with 
Sec. 165.110(c)(1). In addition, any bottled water containing a 
substance at a level considered injurious to health is deemed to be 
adulterated regardless of whether or not the label bears a statement of 
substandard quality. FDA has authority to take regulatory action 
against such product under section 402(a)(1) of the act.
    Under the SDWA, EPA monitors drinking water and establishes 
regulations to protect the public from the adverse health effects of 
contaminants in public drinking water. FDA's microbiological standard, 
like other bottled water standards, follows EPA's requirements for 
drinking water. Thus, even though the microbiological standard was 
established for quality purposes and not safety, FDA concludes that it 
is adequate to protect the public health. The agency points out that 
should EPA require disinfection of drinking water, FDA will consider 
mandatory disinfection of bottled water.

F. Laboratory and Personnel Approval

    IBWA requested that the CGMP regulations be revised to include 
requirements for certification of laboratories that analyze water and 
of supervisory personnel. The agency stated in the proposal that the 
act did not provide authority to the agency to require such approval, 
and that even if such authority were provided by the act, the agency 
lacked the resources to monitor analytical laboratories and personnel 
in the absence of a significant public health problem. Under 
Sec. 129.35(a)(3)(iii), analysis of samples may be performed for the 
plant by competent commercial laboratories. The agency did not receive 
comments concerning laboratory personnel.
    111. A number of comments urged FDA to require the use of certified 
laboratories to test bottled water. Comments stated that laboratories 
performing analyses should be validated in some manner to ensure their 
competency, although FDA need not be the validator. One comment stated 
that the public is better and more consistently protected by requiring 
that certified laboratories conduct the required analyses.
    One comment stated that the compliance of bottled water with 
quality standards is directly related to the competence and reliability 
of the laboratories that perform the analysis for contaminants. It 
stated that it is not clear what FDA means by ``competent commercial 
laboratories.'' It asked, concerning the criteria that would be used to 
determine whether a laboratory is competent, who would determine 
whether a laboratory meets these criteria, and how would a bottler be 
able to determine that a laboratory is able to provide valid test 
results. The comment stated that the term ``competent'' is too vague 
and will not promote uniformity. Another comment stated that the use of 
uncertified, ``competent'' laboratories provides little assurance that 
contaminants, even when present, will be detected.
    Comments stated that, because EPA requires that determinations of 
compliance with its MCL's be based on data generated by a certified 
drinking water laboratory, it would be consistent with the spirit of 
the MOU between FDA and EPA for FDA also to require the use of 
certified laboratories. The comments stated that FDA would not have to 
expend resources because certification programs are in place and 
administered by the States, with laboratories bearing the cost. They 
added that FDA's adoption of a laboratory certification requirement 
would be consistent with its stated intent of incorporating EPA 
drinking water analytical methods for determining compliance with 
bottled water quality standards.
    Comments stated that bottled water laboratory testing certification 
is a major problem that must be addressed by FDA. They stated that, 
currently, a number of State regulatory agencies require that bottled 
water sold in their States be tested in one of their State-certified 
laboratories, and that this issue causes undue replication expenses for 
multiple State licensing and hinders free interstate commerce.
    One comment stated that water bottlers should be encouraged to 
perform laboratory tests on site. It stated that transportation to a 
certified laboratory can require considerable time and can delay 
results. The comment stated that while it is important for a certified 
laboratory to serve as a reference, water bottlers would best serve the 
public by performing analyses on site.
    The agency disagrees that it should require the use of certified 
laboratories to test bottled water. Under Sec. 129.35(a)(3)(iii), 
analysis of the water samples may be performed for the plant by 
competent commercial laboratories. Thus, laboratories used to analyze 
bottled water must be competent whether or not they have been certified 
competent. A competent laboratory is one that is capable of performing 
the required analyses and of obtaining valid and accurate results from 
its analyses. Any laboratory that has been certified by EPA or a State 
to test drinking water is deemed to be a competent laboratory. EPA- and 
State-certified laboratories may be used for comparative purposes 
against other commercial laboratories or a plant's own laboratory. To 
clarify that the agency believes that EPA- and State-certified 
laboratories are appropriate to perform water analyses to demonstrate 
compliance with parts 129 and 165, FDA is amending 
Sec. 129.35(a)(3)(iii) to specifically cite EPA- and State-certified 
laboratories as examples of competent laboratories. Failure to have 
been certified will not preclude a laboratory from being considered 
competent, but the existence of such certification will eliminate any 
doubt about the laboratory's competency.
    FDA agrees with the comment that stated that water bottlers should 
be encouraged to perform laboratory tests on site. Manufacturers of 
many types of foods effectively perform their own routine laboratory 
tests on their products. To the extent possible, bottled water 
manufacturers should perform routine tests on bottled water. For 
example, testing for microbiological quality must be conducted at least 
once a week for source water (Sec. 129.35(a)(3)), as often as necessary 
for product water (Sec. 129.80(a)), and at least once a week 

[[Page 57117]]
for the finished product (Sec. 129.80(g)(1)). Manufacturers can obtain 
quick, reliable results using their own laboratories versus the time it 
would take to send the samples to a commercial laboratory. However, 
firms must ensure the competency of their labs.
    The comments have not convinced the agency that the public health 
will be better protected by requiring the use of certified 
laboratories. Regardless of the laboratory used for testing, water 
containing any substance at a level considered injurious to health is 
deemed to be adulterated (see section 402(a)(1) of the act and 
Sec. 165.110(d)). Thus, the agency concludes that the public health is 
already protected.
    The MOU between FDA and EPA delineates jurisdiction over types of 
drinking water but does not consider the issue of certified 
laboratories. Although FDA incorporates EPA methods into the quality 
standard, FDA has yet to be convinced that only EPA- or State-certified 
laboratories are capable of using EPA methods.
    In response to the comment concerning States requiring additional 
testing in laboratories certified in their own States, the agency 
points out that regardless of whether it required the use of certified 
labs, the CGMP regulations are not preemptive and does not preclude 
States from establishing stricter requirements for bottled water sold 
in their States.

G. Annual Plant Inspection

    IBWA requested that FDA revise the CGMP regulations to include a 
requirement for annual plant inspections to ensure compliance with the 
regulations. FDA stated in the January 1993, proposal that without a 
clear indication of a significant public health problem that could not 
be corrected by other means, there is no basis for FDA to adopt such a 
requirement for bottled water. FDA recognized, however, that IBWA 
requires third party inspection of its member firms, and FDA encourages 
such self-regulated programs within industry.
    112. A number of comments stated that FDA did not provide 
sufficient rationale for not imposing annual plant inspection 
requirements on the growing bottled water industry. Several comments 
stated that annual inspections would reduce the likelihood that 
bottlers would be out of compliance for extended periods of time. One 
comment stated that, irrespective of who performs the inspection, FDA 
should require inspections at least biannually for bottled water 
plants. It added that FDA could contract with State regulatory agencies 
to accomplish these inspections.
    Some comments encouraged FDA to consider third party inspections 
because third party inspections would ensure compliance with the 
regulations without requiring FDA to increase resource requirements. 
One comment urged FDA to modify Sec. 129.80(g) to include a requirement 
for annual inspections by a qualified third party organization because 
it would address expressed State government concerns. It stated that 
some State governments require that companies submit a report issued by 
a recognized organization that inspects bottled water systems for 
compliance with part 129 (i.e., NSF International or other 
organization, State, or country with an inspection protocol as 
stringent as NSF's).
    The agency disagrees with the comments and affirms that, in the 
absence of a significant public health problem, the hazards from 
bottled water do not warrant this requirement.
    The monitoring/inspectional aspect of FDA's program is carried out 
by its field force. The agency monitors and inspects bottled water 
products and processing plants as part of its compliance programs for 
foods. There are roughly 30 compliance programs for foods covering the 
full range of potential food safety problems, including chemical 
contaminants, pesticides, filth, and food additives. About one-half of 
the programs are for imported foods. They provide broad guidance to the 
field on the agency's inspectional priorities. The agency's work plan 
further specifies the number of inspections, sample collections, wharf 
exams, analyses, and other activities in each program by district. The 
districts have considerable latitude as to the establishments that they 
inspect and the products that they examine to allow for adequate 
coverage of local problems and regionalized industry.
    Bottled water establishments are covered under the general food 
safety program. Bottled water plants, along with carbonated beverage 
bottling plants and warehouses, generally are assigned low priority for 
inspection. Priorities are based on factors such as the potential for a 
public health problem and the violation rate of the industry. When 
compared to products such as low-acid canned foods and products in 
which Listeria or Salmonella have a significant potential to develop, 
bottled water products are a relatively low public health problem.
    FDA's experience over the years has supported that ranking (Ref. 
24). Studies of bottled water products have generally not found 
significant problems in these products (id). Consequently, bottled 
water plants shipping in interstate commerce are inspected about once 
every 4 years, unless the firm is violative. The frequency of 
inspection of violative firms is accelerated depending on the number, 
significance, and recurrence of violations. Furthermore, the districts 
follow up on consumer and trade complaints and other leads, as 
appropriate, on potentially violative bottled water products.
    FDA also contracts with the States to perform some bottled water 
plant inspections. The FDA district offices are generally in contact 
with their State counterparts to exchange information about compliance 
problems, inspectional coverage, and new food establishments. In 
addition to FDA inspection, the State and local governments have their 
own inspection and licensing programs. Therefore, FDA concludes that it 
need not mandate annual plant inspections for bottled water.
    113. One comment suggested that FDA consider establishing specific 
criteria for the operation of a bottled water plant to ensure that 
there is compliance with CGMP's for bottled water manufacturing. It 
stated that it is a lot easier for an inexperienced person to establish 
a bottling facility for water, capable of producing high volumes of 
product, than it is to start up with other food products. The comment 
held that an effective licensing program is needed far more for this 
type of product than for other foods and beverages because of a greater 
risk to the public.
    Another comment suggested that FDA establish for its quality 
standards some type of monitoring timeframes along with deadlines for 
submission of monitoring results from State-approved drinking water 
laboratories.
    FDA notes that it has established a CGMP regulation in part 129 for 
the processing and bottling of drinking water. Thus, FDA has 
established regulations on how to operate a bottled water plant. 
Bottled water produced in violation of part 129 is adulterated under 
section 402(a)(4) of the act in that the food has been prepared, 
packed, or held under unsanitary conditions whereby it may have become 
contaminated with filth, or whereby it may have been rendered injurious 
to health.
    Part 129 requires monitoring of the source water, product water, 
and finished product. According to Sec. 129.35(a)(3), samples of source 
water must be taken and analyzed at a minimum frequency of once each 
year for chemical contaminants and once every 4 years for radiological 

[[Page 57118]]
contaminants. Additionally, source water obtained from somewhere other 
than a public water system is to be sampled and analyzed for 
microbiological contaminants at least once each week. Test and sample 
methods must be consistent with the minimum requirements set forth in 
Sec. 165.110(b).
    Product water samples must be taken after processing and before 
bottling, and analyzed as often as is necessary to assure the 
uniformity and the effectiveness of the processes performed by the 
plant (Sec. 129.80(a)).
    The compliance procedures for the finished product are set forth in 
Sec. 129.80(g). A firm must test a representative sample of each 
product for bacteriological contamination at least once a week. To 
ensure chemical, physical, and radiological quality, a manufacturer 
must take and analyze at least annually a representative sample of each 
product. The finished bottled water must comply with the quality 
standard in Sec. 165.110(b).
    Plants must retain all records required by part 129 for not less 
than 2 years, and these documents must be available for official review 
at reasonable times (Sec. 129.80(h)). These records must be available 
for FDA plant inspections. The agency notes that it does not have the 
resources to review bottled water test results except during FDA plant 
inspections.
    Thus, while FDA has not established a licensing requirement for 
water bottlers, it has established a regulatory regime to ensure the 
safety and quality of bottled water products.

H. Recall Procedures

    IBWA requested that FDA establish specific recall procedures for 
bottlers and dealers in the CGMP regulations. In the January 1993 
proposal FDA found no basis for this requested revision.
    114. A number of comments stated that FDA did not provide 
sufficient rationale in the proposal for not establishing specific 
recall procedures for bottlers and dealers in the growing bottled water 
industry.
    One comment stated that, although there should not be specific 
recall procedures in the regulations, language that requires that a 
written recall plan or document be maintained by the bottler should be 
included in the FDA regulations. It stated that the existence of such a 
plan would ensure a quick response by a bottler in the event that a 
recall is necessary.
    The agency notes that part 7 (21 CFR part 7), subpart C provides 
guidelines on policy, procedures, and industry responsibilities for 
recalls. In Sec. 7.59, FDA advises firms to: (1) Prepare and maintain a 
current written contingency plan for use in initiating and effecting a 
recall; (2) use sufficient coding of regulated products to make 
possible positive lot identification and to facilitate effective recall 
of all violative lots; and (3) maintain such product distribution 
records as are necessary to facilitate locating of products that are 
being recalled. Such records should be maintained for a period of time 
that exceeds the shelf life and the expected use of the product.
    The agency notes that recall is a voluntary action that takes place 
because manufacturers and distributors carry out their responsibility 
to protect the public health and from products that present risks of 
injury or gross deception or are otherwise defective. Recall is an 
alternative to an FDA court action for removing distributed products 
from interstate commerce.
    FDA is not aware of any circumstances that establish that there is 
a unique problem with recalls of bottled water. Therefore, FDA 
concludes that the guidelines for recall procedures for foods are 
adequate. If a firm refuses to undertake a recall that is requested by 
FDA, or where FDA has reason to believe that a recall would not be 
effective, determines that a recall is ineffective, or discovers that a 
violation is continuing, it may initiate seizure, multiple seizure, or 
other court action.

V. Other Matters

A. Ozone

    The agency proposed to specify in Sec. 184.1563(d) that the term 
``bottled water,'' for purposes of this section, does not include 
mineral water with TDS greater than 500 ppm. The agency stated that 
this action is necessary to ensure that FDA's rulemaking on the 
definition of bottled water in Sec. 165.110 does not inadvertently have 
the effect of expanding the permitted uses of ozone.
    115. Two comments objected to the exclusion of mineral water from 
ozonation. One of the comments stated that this exclusion conflicts 
with other FDA proposals to include mineral water as a bottled water. 
It stated that California has permitted the ozonation of mineral water 
for many years, and that ozonation is by far the most common means of 
germicidal water treatment that California mineral water firms use.
    Another comment stated that there is no known reason to preclude 
ozonation as the antimicrobial agent for mineral water with TDS's 
greater than 500 ppm, provided that the maximum residual level 
requirements are met. It stated that the difference between mineral 
water and bottled water is only how much ozonation is required, at what 
temperature, and for how long a period of time.
    The agency has reconsidered its January 1993, proposal in light of 
these comments and of its original decision to affirm the use of ozone 
in bottled water as generally recognized as safe (GRAS). In that 
decision (47 FR 50209, November 5, 1982), FDA noted its 1968 opinion 
that ozone used to disinfect potable water is GRAS if it is used in 
accordance with CGMP and with the recommendations of the U.S. Public 
Health Service. The only restriction was that the water must be 
potable. FDA also noted the continuous use of ozone in Europe for 
disinfecting municipal water for nearly 70 years without any evidence 
of toxicity. To ensure that the levels of any oxidation products formed 
are low and safe, the agency included a requirement in the GRAS 
affirmation regulation that the starting water, before ozonation, meet 
the microbiological, physical, chemical, and radiological quality 
standards for bottled water specified in Sec. 103.35 (b) through (e). 
FDA considers this requirement to be a clarification of what it 
considered to be CGMP, namely, that ozone would not be used to 
disinfect polluted water.
    A restriction on the use of ozone in mineral water with TDS greater 
than 500 ppm does not specifically address the goal of the proposal 
which was to ensure that the level of oxidation products do not exceed 
the levels anticipated when the GRAS affirmation regulation was issued. 
The oxidation products of concern from the use of ozone that were 
considered in establishing the GRAS regulation were those from 
dissolved organic material, whereas the increased solids content of 
mineral water consists primarily of minerals (inorganic material). 
Moreover, the restriction in the GRAS affirmation regulation that the 
use of ozone in disinfecting water be in accordance with CGMP means 
that only water that meets the new standard in Sec. 165.110(b), which 
limits the amount of dissolved organic material that may be present, 
will be processed with ozone. Therefore, FDA has decided that there is 
no need to include the restriction limiting the TDS to 500 ppm for 
mineral water in the GRAS affirmation regulation for ozone.
    Of relevance in this regard is the fact that bromate can be formed 
when ozone is used on waters that contain sufficient levels of bromide 
(a mineral component). EPA has conducted an evaluation of bromate and 
classified it as a probable human carcinogen because bromate 
administered to rodents in their 

[[Page 57119]]
drinking water has been shown to produce several types of tumors in 
both sexes. EPA has proposed an MCLG for bromate of zero and an MCL of 
10 micrograms (g)/L (59 FR 38668, July 29, 1994). In the event 
EPA establishes an MCL for bromate in drinking water, then in 
accordance with section 410 of the Act FDA will propose to establish an 
allowable level for bromate in bottled water in Sec. 165.110(b). The 
agency further emphasizes that water that is treated with ozone that 
results in bromate levels that may be injurious to health is 
adulterated under section 402(a)(1) of the Act.

B. Nutrition Labeling

    116. One comment stated that it was concerned with the level of 
sodium that is allowed under the current regulations, while still 
allowing the label to claim that the food is ``sodium free'' or ``salt 
free.'' It stated that FDA permits the label to claim ``sodium free'' 
up to 21.1 ppm in bottled water. The comment noted that bottlers who 
use ion exchange in their treatment process can actually add sodium to 
the bottled water. The comment expressed concern about any regulation 
that permits advertising of ``sodium free'' when there actually is 
sodium in the bottled water.
    The agency discussed this aspect of its ``sodium-free'' regulation 
in the Federal Register of January 6, 1993 (58 FR 2302 at 2321) and 
stated that it believes that it is appropriate to apply the term 
``free'' to a nutrient when a food contains that nutrient in a 
dietetically trivial or physiologically inconsequential amount, even 
though the nutrient is present at a level at or near its reliable limit 
of quantitation. With modern analytical methods, the level at which the 
presence of a nutrient may be quantified is becoming increasingly 
smaller.
    For example, there are almost no foods that can be said to be truly 
sodium free, yet the level of sodium present in some foods has no 
impact on the diet. The Daily Recommended Value for sodium is 2,400 mg. 
Thus, the agency concluded that a food containing less than 5 mg per 
reference amount customarily consumed (reference amount) could be 
considered sodium free because 5 mg is a dietarily insignificant 
fraction of 2,400 mg. The reference amount for bottled water is 240 mL. 
Therefore, the claim ``sodium free'' may be used on a bottled water 
label if the sodium content is less than 5 mg per 240 mL serving (21 
ppm). If a ``sodium free'' claim is made, the bottled water must bear 
nutrition labeling in accordance with Sec. 101.9.
    The agency points out that although the term ``salt'' is not 
synonymous with ``sodium,'' salt refers to sodium chloride. Under 
Sec. 101.61(c)(1), the term ``salt free'' may be used on the label or 
in labeling of foods only if the food is ``sodium free.''
    FDA recognizes that some sodium may be added to water during ion 
exchange treatment. The label of the bottled water product treated in 
this manner could still qualify to bear the statement ``sodium free'' 
if the sodium content of the final product is less than 5 mg per 240 mL 
serving. However, if the sodium content is 5 mg or greater per 240 mL 
serving, the bottled water must bear nutrition labeling and could not 
be labeled as ``sodium free.''
    117. One comment asked that bottled water have a qualified 
exception from the nutrition labeling regulations except when a claim 
is made that the water contains a significant level of a nutrient or 
nutrients. It stated that in that event, nutrition labeling for the 
nutrient for which the claim is made would be required. The comment 
stated that, for example, if a bottled water bore a claim of ``no 
sodium'' or ``no calories,'' it could be accompanied, on the 
information panel, by a statement, ``not a significant source of 
________'' with the blank filled in with the items claimed in the 
statement. Another comment questioned why the declaration ``sodium 
free'' would trigger a nutritional panel for information on fat and 
calories when it is common knowledge that water does not contain these 
nutrients.
    One comment requested that FDA exempt bottled water products other 
than mineral water from nutrition labeling. It stated that consumers do 
not expect any nutrition from bottled water, except perhaps for some 
minerals in mineral water. It suggested that bottled water with less 
than 250 ppm TDS (i.e., bottled water that is not mineral water) be 
exempted from nutrition labeling, even if fluoride is added. It stated 
that label space was a problem.
    FDA notes that the requested exemptions and modifications for 
nutrition labeling fall outside the scope of this rulemaking. However, 
FDA discussed these issues in the final rule on nutrition labeling of 
January 6, 1993 (58 FR 2079 at 2149), and stated that:

    A recent IOM [Institute of Medicine] report, ``Food Labeling: 
Toward National Uniformity'' (Ref. 25), noted that many States have 
expressed concern about the heightened potential for consumer 
confusion because of the increased number of bottled water products 
on the market and the aggressive marketing and advertising claims of 
superiority made for them. Thus, FDA maintains its position that 
nutrition information relating to food must be provided for all 
products, including bottled and mineral water, that contain more 
than insignificant amounts of any 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 in any context. For products that qualify for 
the simplified format, if manufacturers voluntarily declare 
nutrients allowable under Sec. 101.9(c) that are not among the 14 
required nutrients (e.g., potassium), the required statement ``Not a 
significant source of ________,'' must be used, with the blank 
filled in with the name of any of the 14 required nutrients or food 
components that are not present or are present in insignificant 
amounts. Moreover, if a product is voluntarily enriched or fortified 
with added vitamins or minerals, any such nutrients must be declared 
using the simplified format and followed by the above statement. 
Thus, a product labeled as ``bottled water, minerals added'' will 
have to bear nutrition labeling.
* * * * *
    Bottled water products containing juice or other flavors are 
subject to the same nutrition labeling requirements as any other 
food. If a product meets the criteria for no nutritional 
significance, and no claims are made, then nutrition labeling is not 
required. A ``sodium free'' declaration on bottled water or on any 
other food label will trigger nutrition labeling, because such a 
claim promotes the nutritional properties of the product.

    As discussed previously under comment 92 of this document, if 
fluoride is added to bottled water, and the label bears a statement to 
indicate this addition, other than in the ingredient statement, the 
label must bear nutrition labeling that complies with the simplified 
format.

C. Preemption

    118. Comments from several States objected to the Federal standards 
of identity for bottled water preempting any State standards that are 
not identical to it, as some States have established regulations for 
bottled water that are more stringent than the FDA standard. One 
comment stated that it is a fundamental right of a State to make 
regulations and standards that are at least as stringent as or more 
stringent than Federal regulations and standards. It contended that 
FDA's role is more appropriately to establish Federal rules that will 
protect the public health and prevent fraudulent claims from being made 
that might mislead consumers of bottled water products. Another State 
held that it has made great efforts to ensure that bottled water meets 
standards at least as stringent as those set forth in EPA's primary 
drinking water regulations.
    A number of comments requested that FDA more clearly explain the 
scope of 

[[Page 57120]]
the preemption provision, and that it specifically address whether the 
agency interprets Federal preemption to apply to certain State 
requirements (i.e., labeling restrictions, laboratory certification, 
and certain testing requirements).
    Comments asserted that many State regulations are costly and do not 
provide consumers with any more protection than is likely to be 
provided by those proposed by FDA. One comment stated that FDA should 
emphasize that a given State should not be allowed to place an undue 
burden on interstate commerce by requiring that analyses be performed 
only in laboratories that are certified by that State, or that analyses 
be performed according to an unduly restrictive frequency unrelated to 
public health protection. The comment added that regulatory activity by 
the States in areas such as standards and environmental protection is 
causing difficulties for those seeking to import goods into the United 
States.
    FDA notes that, under section 403A(a)(1) of the act (21 U.S.C. 343-
1(a)(1)), a State may not establish or continue in effect a standard of 
identity for a food that is the subject of a standard of identity under 
section 401 of the act if the State standard is not identical to the 
Federal standard. Section 403A(a)(1) of the act only effects preemption 
with respect to matters on which a Federal requirement exists. If there 
is no Federal requirement to be given preemptive effect, preemption 
does not occur.
    Under Sec. 100.1(c)(4), if the State requirement is identical to 
the Federal law, there is no issue of preemption. In addition, if the 
State requirement does the same thing that the Federal law does, even 
if the words are not exactly the same, then it is effectively the same 
requirement as the Federal requirement. FDA's view, as embodied in 
Sec. 100.1(c)(4), is that such a State or local requirement is 
consistent with the Federal requirement. Therefore, the only State 
requirements that are subject to preemption are those that are 
affirmatively different from the Federal requirements on matters that 
are covered by section 403A(a) of the act.
    FDA acknowledges that some stringent State laws will be preempted 
by less restrictive Federal regulations. However, one of the goals of 
the national uniformity provisions of the 1990 amendments was to give 
industry some relief from some types of State requirements that 
interfere with their ability to market products in all 50 States in an 
efficient and cost-effective manner (Statement of Rep. Madigan, 136 
Congressional Record H12954 (October 26, 1990)). Thus, in enacting the 
1990 amendments, Congress apparently decided that even though Federal 
requirements may preempt more restrictive State requirements in certain 
instances, the net benefits from national uniformity in these aspects 
outweigh the loss in consumer protection that may occur as a result.
    The agency notes that certain State laws and regulations will not 
be preempted because FDA's requirements have not been given preemptive 
effect. Therefore, a State will not be precluded from enforcing its 
provisions in such circumstances. The agency points out, for example, 
that FDA has not sought to give preemptive effect to part 129. 
Therefore, if a State has stricter requirements than those in part 129, 
the State standard is not preempted by the Federal requirement.
    The agency advises that, in those instances where a State 
requirement is preempted and the State believes that there are 
significant protections of the public that will be lost as a result, 
the State may petition the agency to modify the standard in question. 
FDA intends to give careful consideration to any such petitions that it 
receives.
    119. Some comments contended that many States have bottlers whose 
products do not cross State lines, thereby avoiding compliance with FDA 
regulations. They suggested that the regulation should include all 
bottlers regardless of intrastate/interstate sales.
    One comment from a State contended that by proposing to apply these 
standards only to interstate manufacturers, FDA establishes an undue 
logistical burden on regulatory agencies, as they would have to 
establish two levels of regulation. The comment argued that more 
consistent regulation is possible by applying the same standards to all 
bottled water firms that desire to sell their products in a particular 
State.
    The agency advises that the act only applies to food that is in, or 
is intended to be shipped in, interstate commerce. Sections 301 and 304 
of the act (21 U.S.C. 331 and 334) specifically describe prohibited 
acts and liability for seizure of food that is held for sale in, is in, 
or has been shipped in interstate commerce. FDA encourages States to 
apply the Federal standard to both interstate and intrastate commerce 
to eliminate two levels of regulation and to avoid undue logistical 
burdens.

VI. Conclusions

    After review and consideration of the comments received in response 
to the January 1993 proposal, FDA concludes that it should amend part 
129 and establish part 165 as set forth in the proposal but with the 
specific modifications to the proposed regulation discussed in this 
document. For the purposes of this final rule, certain changes, in 
addition to those discussed in this document, were made for editorial 
purposes, clarity, and consistency only. These changes do not modify 
any matter of substance.

VII. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule (58 FR 393, January 5, 
1993). No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.

VIII. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). According to Executive 
Order 12866, a regulatory action is ``economically significant'' if it 
meets any one of a number of specified conditions, including having an 
annual effect on the economy of $100 million or adversely affect in a 
material way a sector of the economy, competition, or jobs. A 
regulation is considered ``significant'' under Executive Order 12866 if 
it raises novel legal or policy issues.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. In compliance with the Regulatory Flexibility Act, 
the agency certifies that the final rule will not have a significant 
economic impact on a substantial number of small entities. Therefore, 
under the Regulatory Flexibility Act, no further analysis is required.
    In the economic assessment to the proposal in this rulemaking (58 
FR 393), FDA considered the costs and benefits of taking this action. 
FDA estimated compliance costs to be between $18 million and $21 
million and benefits to be approximately $35 million plus the value of 
any increase in interstate 

[[Page 57121]]
commerce that might occur because of the elimination of conflicting 
State regulations. Thus, benefits were estimated to exceed costs by 
from $14 million to $17 million, plus the value of any increase in 
interstate commerce in bottled water.
    The comments to the proposal discussed three issues relevant to the 
economic assessment. The first issue involves the ability of the 
product definitions adopted in this final rule to communicate 
information about bottled water products to consumers. The second issue 
involves the cost of label changes. The third issue involves the 
economic consequences of the definitions and labeling requirements 
adopted in this final rule for particular bottled water manufacturers.

A. Ability of Definitions To Communicate Information to Consumers

    Some comments suggested or provided data indicating that some of 
the definitions for particular types of bottled water adopted in this 
final rule may not correspond to some consumers' current ideas about 
the essential features of various types of bottled water. The 
implication of these comments is that the definitions adopted in this 
final rule will generate confusion over the characteristics of these 
products.
    Although FDA acknowledges that some of the definitions may not 
correspond to some consumers' current ideas about the essential 
features of some types of bottled water, this phenomenon does not 
necessarily imply that confusion over these products will be increased 
by this final rule. In States in which these products are not currently 
defined, the terms currently used to refer to various bottled water 
products may also not correspond to some consumers' current ideas about 
the essential features of those types of bottled water. Similarly, in 
States in which these products are already defined, the State 
definitions may also not correspond to some consumers' current ideas 
about the essential features of those types of bottled water.
    Other comments suggested that alternative definitions could be 
adopted that would be more consistent with most consumers' current 
ideas about the essential features of various types of bottled water 
than the definitions adopted in this final rule. These comments imply 
confusion will be greater under the definitions adopted in this final 
rule than under the alternative definitions. Similarly, some comments 
suggested definitions already adopted by particular States are more 
consistent with consumers' current ideas about the essential features 
of various types of bottled water than the definitions adopted in this 
final rule. These comments imply confusion will be increased if 
existing state definitions are superseded by the definitions adopted in 
this final rule.
    For example, a number of comments suggested that most consumers 
believe ``spring water'' must be extracted from the natural orifice of 
a spring and not from a bore hole. This final rule defines ``spring 
water'' to include water extracted from both the natural orifice of a 
spring and from a bore hole tapping the underground formation feeding 
the spring. The comments imply the definition of ``spring water'' 
adopted in this final rule will generate greater confusion over the 
characteristics of this product than would a definition specifying that 
``spring water'' be extracted from the natural orifice of a spring. As 
discussed in the preamble to this document, FDA believes that these 
comments are in error, and that most consumers do not believe ``spring 
water'' must be extracted from the natural orifice of a spring.
    Another comment discussed the results of a survey in which the 
majority of respondents thought ``artesian well water'' flowed to the 
surface due to natural pressure. In contrast, the geological definition 
of an artesian well does not imply water from this type of well flows 
to the surface due to natural pressure. The definition of ``artesian 
well water'' adopted in this final rule is consistent with the 
geological definition of an artesian well and does not require that 
this type of water flow to the surface due to natural pressure. The 
comment suggested the definition adopted in this final rule will create 
more confusion over the characteristics of this product than would a 
definition specifying that ``artesian well water'' flows to the surface 
due to natural pressure.
    FDA acknowledges that many consumers may be unaware of the 
geological definition of an ``artesian well,'' and that, in the short 
run, the definition of ``artesian well water'' adopted in this final 
rule may lead some consumers to be confused over the characteristics of 
this product. However, in the long run, this confusion will be less 
than the confusion that would be generated if FDA failed to adopt a 
definition for this term or adopted a definition that failed to 
correspond to the accepted geological definition of an artesian well. 
Adopting a standardized definition for this term will increase the 
ability of interested consumers to interpret this term. Adopting a 
standardized definition consistent with accepted geological terminology 
will increase the ability of interested consumers to attain information 
on this type of water.
    Comments also discussed a number of other elements of the 
definitions adopted in this final rule. These comments are addressed in 
the preamble to this document. These comments do not provide sufficient 
information to establish that alternative definitions would be more 
consistent with most consumers' current ideas about the essential 
features of various types of bottled water than the definitions adopted 
in this final rule.

B. The Cost of Label Changes

    Comments provided a wide range of estimates of the cost of 
relabeling bottled water products to conform to the proposed 
definitions and labeling requirements. One comment suggested label 
changes will cost $2,000 per product, per location, not including the 
cost of the actual label. Another comment suggested the cost of each 
label plate change alone will be $200. Another comment suggested it 
will cost a single firm ``hundreds of thousands of dollars'' to change 
their labels.
    In the economic assessment of the proposal in this rulemaking, FDA 
used an average relabeling cost of $45,000 per label change. This cost 
estimate was based on information previously provided by a bottled 
water manufacturer. Although the comments suggest the cost of 
relabeling may be highly variable across firms, and that the cost of 
relabeling may be lower than $45,000 per label for many firms, the 
comments do not provide sufficient information to determine an 
appropriate adjustment in the average cost of relabeling.
    Some comments implied that changes in advertising would also be 
required to accommodate the product definitions established under this 
final rule. In the economic assessment to the proposal in this 
rulemaking, FDA did not consider these costs because FDA believed the 
proposed definitions were sufficiently broad that no firm legally 
selling a given type of bottled water would be unable to do so because 
of the proposed regulation.
    One comment suggested 44 brands of bottled water currently marketed 
as mineral water in the United States would no longer be able to be 
marketed as mineral water under this final rule. However, the only 
brands listed in this comment were Mountain Valley, Volvic, and Poland 
Spring. Based on the information available to the agency, this comment 
is in error. It appears that no 

[[Page 57122]]
mineral water is actually being marketed under these brand names.
    Another comment suggested most of the mineral water sold in the 
world, including the U.S. market, is produced in Europe, and that these 
products currently exhibit a wide range of total dissolved solids (TDS) 
levels, from under 100 mg/L to over 1,000 mg/L. The implication of this 
comment is that some mineral water produced in Europe with less than 
250 ppm TDS is currently being marketed as mineral water in the United 
States and would no longer be able to be marketed as mineral water 
under this final rule. However, this comment did not identify any 
European brands that would actually be affected in this manner, and FDA 
is not aware of any such brands.
    FDA, therefore, has no information that this final rule will 
require extensive modification of existing advertising.

C. Economic Consequences of Definitions and Other Labeling Requirements 
on Particular Bottled Water Manufacturers

    A number of comments suggested that the definitions and the 
labeling requirements in this final rule will have a negative impact on 
the sales of some bottled water products and thus a negative impact on 
some bottled water manufacturers.
    Two comments suggested that some water currently sold as mineral 
water would no longer be able to be sold as mineral water under this 
final rule, and that this would have a negative impact on the sales of 
those products. This issue is different from the advertising cost 
issue, which is the context in which these same comments were discussed 
in the preceding section. However, FDA's response to these comments is 
the same in this context as in the context of advertising costs. FDA is 
not aware of any brand of mineral water that will no longer be able to 
be marketed as mineral water under this final rule.
    Another comment noted the definition of ``bottled water'' does not 
allow for the addition of ingredients such as minerals for flavor, 
sodium fluoride, flavors which comprise less than one percent by 
weight, and carbon dioxide. According to this comment, many products 
currently sold simply as ``bottled water'' contain these ingredients, 
and that by causing these products to be labeled differently, this 
final rule will generate a tremendous adverse economic impact on the 
firms producing these products. FDA believes this comment is in error 
because it is currently illegal to sell water containing these 
ingredients as simply ``bottled water,'' and FDA is not aware of any 
products that are labeled in this manner.
    Another comment suggested that if drinking water is not recognized 
by FDA as a specific type of bottled water, severe economic 
repercussions would occur for companies that currently sell bottled 
drinking water. This final rule does not define ``drinking water'' as a 
specific type of bottled water, although it does allow for the use of 
the term ``drinking water'' as a synonym for ``bottled water.'' 
However, this comment provided no information to support the claim that 
consumers believe drinking water is a specific type of bottled water. 
In addition, nearly all bottled water sold in the United States meets 
the conditions suggested in this comment as being peculiar to drinking 
water. Therefore, FDA does not believe the sales of drinking water will 
be significantly affected by this final rule.
    Another comment suggested that the additional labeling requirements 
for bottled water marketed for use in infant formula will cause a 
negative impact on the sales of these products and will effectively 
destroy this product line. However, the comment provided no information 
to support this claim. Therefore, there is no basis for FDA to take any 
action in reliance on this comment.

D. Conclusions

    The economic assessment to the proposal in this rulemaking (58 FR 
393) estimated net benefits of $14 million to $17 million plus the 
value of any increase in interstate commerce that might occur because 
of the elimination of conflicting State regulations.
    The previous economic assessment did not consider the potential 
effect of the definitions and labeling requirements on the level of 
consumer confusion over bottled water products. Accounting for this 
effect will probably increase estimated net benefits. However, FDA has 
insufficient information to estimate this increase in net benefits.
    In addition, the definitions and labeling requirements adopted in 
this final rule may result in a decrease in the sales of some products 
and an increase in the sales of other products. However, FDA has 
insufficient information to determine the size or significance of these 
effects.
    Therefore, FDA estimates that the benefits of this final rule will 
exceed the costs by $14 million to $17 million, plus the value of any 
increase in interstate commerce which might occur because of the 
elimination of conflicting State regulations and the value of any 
reduction in consumer confusion over these products.

IX. Effective Date

    FDA proposed that any final rule that was issued based upon the 
proposal would become effective 180 days following issuance of the 
final rule.
    120. One comment asked FDA to consider the cost and phase- in 
considerations for bottled water companies whose main business involves 
3-, 5-, or 6-gallon reusable polycarbonate silk-screened bottles. The 
comment stated that these bottles, which are generally recycled when no 
longer fit for use, cost approximately $4 to $5 each and have a normal 
life span of 5 to 7 years, although they can last 10 years or longer. 
It stated that a company with about $6 million in sales has an 
inventory of about 200,000 bottles or a bottle investment of $800,000 
to $1,000,000. The comment maintained that any change in labeling 
requirements has major potential expense implications for bottlers 
using 3-, 5-, or 6-gallon polycarbonate silk screened bottles. It held 
that any relabeling of these bottles with adhesive labels can be costly 
and presents potential problems in the washing process. It asked that 
consideration be given to extended phase-in periods for reusable 
bottles where a change in labels is required because of the new 
regulations.
    Under section 403(g) of the act, a food is deemed to be misbranded 
if it purports to be, or is represented as, a food for which a 
definition and standard of identity has been prescribed by regulation 
unless it conforms to such definition and standard, and its label bears 
the name of the food specified in the definition and standard. Thus, 
all bottled water labels must bear appropriate labeling in conformance 
with an effective standard of identity.
    FDA recognizes that some bottled water labels will have to be 
modified to comply with the standard of identity for bottled water, 
even though the definitions are based on current meanings of terms. The 
agency has provided for additional nomenclature (e.g., ``drinking 
water'') in this final rule, and as a result, many label changes that 
the comment may have anticipated will not be required.
    However, FDA realizes that it may be a hardship for some firms to 
make required label changes on reusable polycarbonate silk-screened 
bottles because these bottles are used for years before replacement, 
and replacement of an entire stock would be burdensome by the effective 
date of this final rule. Therefore, the agency is allowing an 

[[Page 57123]]
alternative means of compliance whereby the labeling information 
required by the standard of identity that is otherwise required on 
reusable polycarbonate silk- screened bottles may be placed on the 
customer invoice or bill of lading that is provided with each delivery. 
This alternative means of compliance is provided in lieu of having the 
labeling information required by the standard of identity permanently 
affixed to an existing bottle as otherwise required by section 201(k) 
of the act. This alternative means of compliance only applies to 
information on the polycarbonate silk-screened bottles and does not 
apply to information on the bottle cap.
    The special labeling provision is provided for currently existing 
containers. As a firm replaces the polycarbonate silk-screened bottles 
presently in use with new ones, the required information must be 
permanently affixed to the new bottles. To fulfill the intent of the 
act, all labeling on the invoice or bill of lading must be in 
compliance with FDA requirements. The agency notes that this 
alternative means of compliance is consistent with that established for 
nutrition labeling under Sec. 101.9(g)(9).

X. References

    The following information has been placed on display in the Dockets 
Management Branch (address above), and may be seen by interested 
persons between 9 a.m. and 4 p.m. Monday through Friday.

    1. Codex Alimentarius, vol. XII, ``Codex Standards for Natural 
Mineral Waters and Edible Ices and Ice Mixes,'' Food and Agriculture 
Organization of the United Nations, World Health Organization, Rome, 
1982.
    2. State of California, Chapter 639, Assembly Bill No. 170, 
September 15, 1987.
    3. ``The Surgeon General's Report on Nutrition and Health,'' 
DHHS, Public Health Service Publication No. 88-50210 (Government 
Printing Office Stock No. 017-001-00465-1), U.S. Government Printing 
Office, Washington, DC, 1988.
    4. Barness, Lewis A., Nutrition and Oral Health, ``Pediatric 
Nutrition Handbook,'' 3d Ed., American Academy of Pediatrics, Elk 
Grove Village, IL, 1993.
    5. Heath, R.C., United States Geological Survey, ``Basic Ground-
Water Hydrology,'' Water-Supply Paper 2220, United States Government 
Printing Office, 1989.
    6. The United States Pharmacopeia, 23d Revision, United States 
Pharmacopeial Convention, Inc., Rockville, MD, 1995.
    7. Association of Food and Drug Officials, ``AFDO Model Bottled 
Water Regulation,'' 1986.
    8. Davis, S.A., memorandum to file, ``A Comparison of 
Definitions for Mineral Water,'' May 11, 1995.
    9. Freeze, R.A. and J.A. Cherry, ``Groundwater,'' Prentice-Hall 
Inc., 1979.
    10. Sax, N.I., and R.J. Lewis, Sr., ``Hawley's Condensed 
Chemical Dictionary,'' Van Nostrand Reinhold Company, 1987.
    11. Florida Department of Agriculture and Consumer Services, 
Bottled Water Plant/Dealer Application Information, July 23, 1992.
    12. Sowards, R.D., Texas Department of Health, letter to Janice 
F. Oliver, July 30, 1991.
    13. Guralnik, David B., ``Webster's New World Dictionary of the 
American Language,'' Warner Books, Inc., 1983.
    14. Mississippi State Board of Health, ``Regulations Governing 
Bottled Water,'' December 1991.
    15. International Bottled Water Association, Model Bottled Water 
Regulation, January 24, 1991.
    16. O'Donnell, W.J., ``Sanpellegrino,'' Proceedings of the 
Bottled Water Workshop, A Report Prepared for the Use of the 
Subcommittee on Energy and Commerce, U.S. House of Representatives, 
U.S. Government Printing Office, Washington, DC, 1990.
    17. The Council of the European Communities, ``Council Directive 
of 15 July, 1980 on the Approximation of the Laws of the Member 
States Relating to the Exploitation and Marketing of Natural Mineral 
Waters,'' Official Journal of the European Communities, No. L. 229/
1, 1980.
    18. Lathrop, Donald B., ``Bacteriological Counts on Infant 
Formulas Mixed in the Home,'' Archives of Pediatrics, 73:451, 1956.
    19. Ducluzeau, R., S. Dufresne, and J.M. Bochand, ``Inoculation 
of the Digestive Tract of Axenic Mice with the Autochthonous 
Bacteria of Mineral Water,'' European Journal of Applied 
Microbiology, 2:127, 1976.
    20. ``Guidelines for Drinking-Water Quality,'' vol. 1, d. ed., 
World Health Organization, 1993.
    21. Mottram, V.H., ``Human Nutrition,'' Edward Arnold 
Publishers, Ltd., 1963.
    22. Allen, H.E., M.A. Halley-Henderson, C.N. Hass, ``Chemical 
Composition of Bottled Mineral Water,'' Archives of Environmental 
Health, vol. 44 (No. 2), p. 102, March/April 1989.
    23. Vasconcelos, J. and S. Harris, ``Consensus Method for 
Determining Groundwaters Under the Direct Influence of Surface Water 
Using Microscopic Particulate Analysis,'' USEPA Manchester 
Environmental Laboratory, Port Orchard, WA, October 1992.
    24. Troxell, T., ``Role of the FDA in Regulating Bottled 
Water,'' Proceedings of the Bottled Water Workshop, A Report 
Prepared for the Use of the Subcommittee on Energy and Commerce, 
U.S. House of Representatives, U.S. Government Printing Office, 
Washington, DC, 1990.
    25. Committee on State Food Labeling, Food and Nutrition Board, 
Institute of Medicine, National Academy of Sciences, ``Food 
Labeling: Toward National Uniformity,'' National Academy Press, 
Washington DC, 1992.

List of Subjects

21 CFR Part 103

    Beverages, Bottled water, Food grades and standards.

21 CFR Part 129

    Beverages, Bottled water, Food packaging, Reporting and 
recordkeeping requirements.

21 CFR Part 165

    Beverages, Bottled water, Food grades and standards, Incorporation 
by reference.

21 CFR Part 184

    Food ingredients.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR 
Chapter I is amended as follows:

PART 103--QUALITY STANDARDS FOR FOODS WITH NO IDENTITY STANDARDS

    1. The authority citation for 21 CFR part 103 continues to read as 
follows:

    Authority: Secs. 201, 401, 403, 409, 410, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 
349, 371, 379e).

Subpart B--[Reserved]

    2. Subpart B, consisting of Sec. 103.35 Bottled water, is removed 
and reserved.

PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER

    3. The authority citation for 21 CFR part 129 continues to read as 
follows:

    Authority: Secs. 402, 409, 701, 704 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 342, 348, 371, 374); sec. 361 of the 
Public Health Service Act (42 U.S.C. 264).

    4. Section 129.35 is amended by revising paragraphs (a)(3)(ii) and 
(a)(3)(iii) and by adding new paragraph (a)(4) to read as follows:


Sec. 129.35  Sanitary facilities.

* * * * *
    (a) * * *
    (3) * * *
    (ii) Test and sample methods shall be those recognized and approved 
by the government agency or agencies having jurisdiction over the 
approval of the water source, and shall be consistent with the minimum 
requirements set forth in Sec. 165.110(b) of this chapter.
    (iii) Analysis of the sample may be performed for the plant by 
competent commercial laboratories (e.g., Environmental Protection 
Agency (EPA) and State-certified laboratories). 

[[Page 57124]]

    (4) Source water testing exemptions. (i) Firms that use a public 
water system for source water may substitute public water system 
testing results, or certificates showing full compliance with all 
provisions of EPA National Primary and Secondary Drinking Water 
Regulations pertaining to chemical contaminants (40 CFR parts 141 and 
143), for the testing requirements of Sec. 129.35(a)(3).
    (ii) Firms that do not use a public water system as the source of 
their water may reduce the frequency of their testing of that source, 
as well as the number of chemical contaminants for which they test the 
source water, if they can document that such reduction is consistent 
with a State-issued waiver under EPA regulations (40 CFR parts 141 and 
143).
    (iii) The finished bottled water must comply with bottled water 
quality standards (21 CFR 165.110(b)) and section 402(a)(1) of the act 
dealing with adulterated foods.
* * * * *
    5. Section 129.80 is amended by revising the introductory text of 
paragraph (g) to read as follows:


Sec. 129.80  Processes and controls.

* * * * *
    (g) Compliance procedures. A quality standard for bottled drinking 
water is established in Sec. 165.110(b) of this chapter. To assure that 
the plant's production of bottled drinking water complies with the 
applicable standards, laws, and regulations of the government agency or 
agencies having jurisdiction, the plant will analyze product samples as 
follows:
* * * * *
    6. New part 165 is added to read as follows:

PART 165--BEVERAGES

Subpart A--General Provisions

Sec.
165.3  Definitions.

Subpart B--Requirements for Specific Standardized Beverages

165.110  Bottled water.

    Authority: Secs. 201, 401, 403, 403A, 409, 410, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 343A, 
348, 349, 371, 379e).

Subpart A--General Provisions


Sec. 165.3  Definitions.

    (a) A lot is:
    (1) For purposes of determining quality factors related to 
manufacture, processing, or packing, a collection of primary containers 
or units of the same size, type, and style produced under conditions as 
nearly uniform as possible and usually designated by a common container 
code or marking, or in the absence of any common container code or 
marking, a day's production.
    (2) For purposes of determining quality factors related to 
distribution and storage, a collection of primary containers or units 
transported, stored, or held under conditions as nearly uniform as 
possible.
    (b) A sample consists of 10 subsamples (consumer units), one taken 
from each of 10 different randomly chosen shipping cases to be 
representative of a given lot, unless otherwise specified in a specific 
standard in this part.
    (c) An analytical unit is the portion(s) of food taken from a 
subsample of a sample for the purpose of analysis.

Subpart B--Requirements for Specific Standardized Beverages


Sec. 165.110  Bottled water.

    (a) Identity--(1) Description. Bottled water is water that is 
intended for human consumption and that is sealed in bottles or other 
containers with no added ingredients except that it may optionally 
contain safe and suitable antimicrobial agents. Fluoride may be 
optionally added within the limitations established in 
Sec. 165.110(b)(4)(ii). Bottled water may be used as an ingredient in 
beverages (e.g., diluted juices, flavored bottled waters). It 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,'' and 
``tonic water.'' The processing and bottling of bottled water shall 
comply with applicable regulations in part 129 of this chapter.
    (2) Nomenclature. The name of the food is ``bottled water,'' 
``drinking water,'' or alternatively one or more of the following terms 
as appropriate:
    (i) 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 is ``artesian water'' or ``artesian well water.'' Artesian 
water may be collected with the assistance of external force to enhance 
the natural underground pressure. On request, plants shall demonstrate 
to appropriate regulatory officials that the water level stands at some 
height above the top of the aquifer.
    (ii) The name of water from a subsurface saturated zone that is 
under a pressure equal to or greater than atmospheric pressure is 
``ground water.'' Ground water must not be under the direct influence 
of surface water as defined in 40 CFR 141.2.
    (iii) The name of water containing not less than 250 parts per 
million (ppm) total dissolved solids (TDS), 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 ``mineral 
water.'' 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. No minerals may be added 
to this water.
    (iv) The name of water that has been produced by distillation, 
deionization, reverse osmosis, or other suitable processes and that 
meets the definition of ``purified water'' in the United States 
Pharmacopeia, 23d Revision, January 1, 1995, which is incorporated by 
reference in accordance with 5 U.S.C. 551(a) and 1 CFR part 51. (Copies 
may be obtained from the United States Pharmacopial Convention, Inc., 
12601 Twinbrook Pkwy., Rockville, MD 20852 and may be examined at the 
Center for Food Safety and Applied Nutrition, 200 C St. SW., 
Washington, DC, or at the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC), may be ``purified water'' 
or ``demineralized water.'' Alternatively, the water may be called 
``deionized water'' if the water has been processed by deionization, 
``distilled water'' if it is produced by distillation, ``reverse 
osmosis water'' if the water has been processed by reverse osmosis, and 
``__________ drinking water'' with the blank being filled in with one 
of the defined terms describing the water in this paragraph (e.g., 
``purified drinking water'' or ``deionized drinking water'').
    (v) The name of 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 may be ``sparkling 
bottled water.''
    (vi) The name of water derived from an underground formation from 
which water flows naturally to the surface of the earth may be ``spring 
water.'' Spring water shall be collected only at the spring or through 
a bore hole tapping the underground formation feeding the spring. There 
shall be a natural force causing the water to flow to the surface 
through a natural orifice. The location of the spring shall be 
identified. Spring water collected with the use of an external force 
shall be from the same underground stratum as the spring, as shown by a 
measurable hydraulic connection using a hydrogeologically 

[[Page 57125]]
valid method between the bore hole and the natural spring, and shall 
have all the physical properties, before treatment, and be of the same 
composition and quality, as the water that flows naturally to the 
surface of the earth. If spring water is collected with the use of an 
external force, water must continue to flow naturally to the surface of 
the earth through the spring's natural orifice. Plants shall 
demonstrate, on request, to appropriate regulatory officials, using a 
hydrogeologically valid method, that an appropriate hydraulic 
connection exists between the natural orifice of the spring and the 
bore hole.
    (vii) The name of water that meets the requirements under 
``Sterility Tests'' <71> in the United States Pharmacopeia, 23d 
Revision, January 1, 1995, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR 51. (Copies may be obtained 
from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook 
Pkwy., Rockville, MD 20852 and may be examined at the Center for Food 
Safety and Applied Nutrition, 200 C St. SW., Washington, DC, or at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC), may be ``sterile water.'' Alternatively, the water may 
be called ``sterilized water.''
    (viii) The name of water from a hole bored, drilled, or otherwise 
constructed in the ground which taps the water of an aquifer may be 
``well water.''
    (3) Other label statements. (i) If the TDS content of mineral water 
is below 500 ppm, or if it is greater than 1,500 ppm, the statement 
``low mineral content'' or the statement ``high mineral content'', 
respectively, shall appear on the principal display panel following the 
statement of identity in type size at least one-half the size of the 
statement of identity but in no case of less than one-sixteenth of an 
inch. If the TDS of mineral water is between 500 and 1,500 ppm, no 
additional statement need appear.
    (ii) When bottled water comes from a community water system, as 
defined in 40 CFR 141.2, except when it has been treated to meet the 
definitions in paragraphs (a)(2)(iv) and (a)(2)(vii) of this section 
and is labeled as such, the label shall state ``from a community water 
system'' or, alternatively, ``from a municipal source'' as appropriate, 
on the principal display panel or panels. This statement shall 
immediately and conspicuously precede or follow the name of the food 
without intervening written, printed, or graphic matter, other than 
statements required by paragraph (c) of this section, in type size at 
least one-half the size of the statement of identity but in no case of 
less than one-sixteenth of an inch.
    (iii) When the label or labeling of a bottled water product states 
or implies (e.g., through label statements or vignettes with references 
to infants) that the bottled water is for use in feeding infants, and 
the product is not commercially sterile under Sec. 113.3(e)(3)(i) of 
this chapter, the product's label shall bear conspicuously and on the 
principal display panel the statement ``Not sterile. Use as directed by 
physician or by labeling directions for use of infant formula.''
    (4) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections 
of parts 101 and 130 of this chapter.
    (b) Quality. The standard of quality for bottled water, including 
water for use as an ingredient in beverages (except those described in 
the labeling as ``water,'' ``carbonated water,'' ``disinfected water,'' 
``filtered water,'' ``seltzer water,'' ``soda water,'' ``sparkling 
water,'' and ``tonic water''), is as follows:
    (1) Definitions. (i) Trihalomethane (THM) means one of the family 
of organic compounds, named as derivatives of methane, wherein three of 
the four hydrogen atoms in methane are each substituted by a halogen 
atom in the molecular structure.
    (ii) Total trihalomethane (TTHM) means the sum of the concentration 
in milligrams per liter of the trihalomethane compounds 
(trichloromethane, dibromochloromethane, bromodichloromethane and 
tribromomethane), rounded to two significant figures.
    (2) Microbiological quality. Bottled water shall, when a sample 
consisting of analytical units of equal volume is examined by the 
methods described in applicable sections of ``Standard Methods for the 
Examination of Water and Wastewater,'' 15th Ed. (1980), American Public 
Health Association, which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51 (copies may be obtained from the 
American Public Health Association, 1015 15th St., NW., Washington, DC 
20005, or a copy may be examined at the Office of the Federal Register, 
800 North Capitol St., NW., suite 700, Washington, DC, or at the Center 
for Food Safety and Applied Nutrition, 200 C St., SW., Washington, DC), 
meet the following standards of microbiological quality:
    (i) Multiple-tube fermentation method. Not more than one of the 
analytical units in the sample shall have a most probable number (MPN) 
of 2.2 or more coliform organisms per 100 milliliters and no analytical 
unit shall have an MPN of 9.2 or more coliform organisms per 100 
milliliters; or
    (ii) Membrane filter method. Not more than one of the analytical 
units in the sample shall have 4.0 or more coliform organisms per 100 
milliliters and the arithmetic mean of the coliform density of the 
sample shall not exceed one coliform organism per 100 milliliters.
    (3) Physical quality. Bottled water shall, when a composite of 
analytical units of equal volume from a sample is examined by the 
method described in applicable sections of ``Standard Methods for the 
Examination of Water and Wastewater,'' 15th Ed. (1980), which is 
incorporated by reference (the availability of this incorporation by 
reference is given in paragraph (b)(2) of this section), meet the 
following standards of physical quality:
    (i) The turbidity shall not exceed 5 units.
    (ii) The color shall not exceed 15 units.\1\
    (iii) The odor shall not exceed threshold odor No. 3.\1\
    (4) Chemical quality. (i)(A) Bottled water shall, when a composite 
of analytical units of equal volume from a sample is examined by the 
methods described in paragraph (b)(4)(i)(B) of this section, meet 
standards of chemical quality and shall not contain chemical substances 
in excess of the following concentrations:

------------------------------------------------------------------------
                                                        Concentration in
                       Substance                         milligrams per 
                                                              liter     
------------------------------------------------------------------------
Arsenic...............................................            0.05  
Chloride\1\...........................................          250.0   
Iron\1\...............................................            0.3   
Manganese\1\..........................................            0.05  
Phenols...............................................            0.001 
Sulfate\1\............................................          250.0   
Total dissolved solids\1\.............................          500.0   
Zinc \1\..............................................            5.0   
Organics:                                                               
  Endrin (1,2,3,4,10,10-hexachloro-6,7-epoxy 1, 4, 4a,                  
   5, 6, 7, 8, 8a-octa-hydro-1,4-endo, endo-5,8-                        
   dimethane naphthalene).............................            0.0002
    Total Trihalomethanes.............................            0.10  
------------------------------------------------------------------------
\1\ Mineral water is exempt from allowable level. The exemptions are    
  aesthetically based allowable levels and do not relate to a health    
  concern.                                                              

    (B) Analyses conducted to determine compliance with paragraph 
(b)(4)(i)(A) of this section shall be made in accordance with the 
methods described in the applicable sections of ``Standard Methods for 
the Examination of Water 

[[Page 57126]]
and Wastewater,'' 15th Ed. (1980), or ``Methods for Chemical Analysis 
of Water and Wastes,'' Environmental Monitoring and Support Laboratory 
(EMSL), EPA-600/4-79-020, March 1983, U.S. Environmental Protection 
Agency (EPA), both of which are incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51.
    (C) Analyses for organic substances shall be determined by the 
appropriate methods set forth below. The methods in paragraphs 
(b)(4)(i)(C)(1) and (C)(2) of this section are incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and are 
described in ``Standard Methods for Examination of Water and 
Wastewater,'' 15th Ed. (1980). Copies may be obtained from the American 
Public Health Association, 1015 Fifteenth St., NW., Washington DC 
20005, and examined at the Office of the Federal Register, 800 North 
Capitol St., NW., suite 700, Washington DC, or the Center for Food 
Safety and Applied Nutrition, 200 C St. NW., Washington DC. The methods 
in paragraphs (b)(4)(i)(C)(3) and (C)(4) are cross-referenced in 40 CFR 
part 141, subpart C, Appendix C.
    (1) ``Methods for Organochlorine Pesticides in Industrial 
Effluents;''
    (2) ``Methods for Chlorinated Phenoxy Acid Herbicides in Industrial 
Effluents,'' November 28, 1973;
    (3) ``Part I: The Analysis of Trihalomethanes in Finished Waters by 
the Purge and Trap Method;'' which is cross-referenced in 40 CFR part 
141, subpart C, appendix C;
    (4) ``Part II: The Analysis of Trihalomethanes in Drinking Water by 
Liquid/Liquid Extraction,'' Method 501.2 which is cross-referenced in 
40 CFR part 141, subpart C, appendix C;
    (ii)(A) Bottled water packaged in the United States to which no 
fluoride is added shall not contain fluoride in excess of the levels in 
Table 1 and these levels shall be based on the annual average of 
maximum daily air temperatures at the location where the bottled water 
is sold at retail.

                                 Table 1                                
------------------------------------------------------------------------
                                                            Fluoride    
  Annual average of maximum daily air temperatures (    concentration in
                        deg.F)                           milligrams per 
                                                              liter     
------------------------------------------------------------------------
53.7 and below........................................               2.4
53.8-58.3.............................................               2.2
58.4-63.8.............................................               2.0
63.9-70.6.............................................               1.8
70.7-79.2.............................................               1.6
79.3-90.5.............................................               1.4
------------------------------------------------------------------------

    (B) Imported bottled water to which no fluoride is added shall not 
contain fluoride in excess of 1.4 milligrams per liter.
    (C) Bottled water packaged in the United States to which fluoride 
is added shall not contain fluoride in excess of levels in Table 2 and 
these levels shall be based on the annual average of maximum daily air 
temperatures at the location where the bottled water is sold at retail.

                                 Table 2                                
------------------------------------------------------------------------
                                                            Fluoride    
  Annual average of maximum daily air temperatures (    concentration in
                        deg.F)                           milligrams per 
                                                              liter     
------------------------------------------------------------------------
53.7 and below........................................               1.7
53.8-58.3.............................................               1.5
58.4-63.8.............................................               1.3
63.9-70.6.............................................               1.2
70.7-79.2.............................................               1.0
79.3-90.5.............................................               0.8
------------------------------------------------------------------------

    (D) Imported bottled water to which fluoride is added shall not 
contain fluoride in excess of 0.8 milligram per liter.
    (iii) Having consulted with EPA as required by section 410 of the 
Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration 
has determined that bottled water, when a composite of analytical units 
of equal volume from a sample is examined by the methods listed in 
paragraphs (b)(4)(iii)(E) through (b)(4)(iii)(F), and (b)(4)(iii)(G) of 
this section, shall not contain the following chemical contaminants in 
excess of the concentrations specified in paragraphs (b)(4)(iii)(A) 
through (b)(4)(iii)(D) of this section.
    (A) The allowable levels for inorganic substances are as follows:

------------------------------------------------------------------------
                                             Concentration in milligrams
                Contaminant                 per liter  (or as specified)
------------------------------------------------------------------------
Barium....................................  2.                          
Cadmium...................................  0.005.                      
Chromium..................................  0.1.                        
Copper....................................  1.0.                        
Lead......................................  0.005.                      
Mercury...................................  0.002.                      
Nitrate...................................  10 (as nitrogen).           
Nitrite...................................  1 (as nitrogen).            
    Total Nitrate and Nitrite.............  10 (as nitrogen).           
Selenium..................................  0.05.                       
------------------------------------------------------------------------

    (B) The allowable levels for volatile organic chemicals (VOC's) are 
as follows:

------------------------------------------------------------------------
                                                        Concentration in
             Contaminant  (CAS Reg. No.)                 milligrams per 
                                                             liter      
------------------------------------------------------------------------
Benzene (71-43-2)....................................              0.005
Carbon tetrachloride (56-23-5).......................              0.005
o-Dichlorobenzene (95-50-1)..........................              0.6  
p-Dichlorobenzene (106-46-7).........................              0.075
1,2-Dichloroethane (107-06-2)........................              0.005
1,1-Dichloroethylene (75-35-4).......................              0.007
cis-1,2-Dichloroethylene (156-59-2)..................              0.07 
trans-1,2-Dichloroethylene (156-60-5)................              0.1  
1,2-Dichloropropane (78-87-5)........................              0.005
Ethylbenzene (100-41-4)..............................              0.7  
Monochlorobenzene (108-90-7).........................              0.1  
Styrene (100-42-5)...................................              0.1  
Tetrachloroethylene (127-18-4).......................              0.005
Toluene (108-88-3)...................................              1    
1,1,1-Trichloroethane (71-55-6)......................              0.20 
Trichloroethylene (79-01-6)..........................              0.005
Vinyl chloride (75-01-4).............................              0.002
Xylenes (1330-20-7)..................................             10    
------------------------------------------------------------------------

    (C) The allowable levels for pesticides and other synthetic organic 
chemicals (SOC's) are as follows:

------------------------------------------------------------------------
                                                        Concentration in
              Contaminant  (CAS Reg. No.)                milligrams per 
                                                              liter     
------------------------------------------------------------------------
Alachlor (15972-60-8).................................           0.002  
Atrazine (1912-24-9)..................................           0.003  
Carbofuran (1563-66-2)................................           0.04   
Chlordane (57-74-9)...................................           0.002  
1,2-Dibromo-3-chloropropane (96-12-8).................           0.0002 
2,4-D (94-75-7).......................................           0.07   
Ethylene dibromide (106-93-4).........................           0.00005
Heptachlor (76-44-8)..................................           0.0004 
Heptachlor epoxide (1024-57-3)........................           0.0002 
Lindane (58-89-9).....................................           0.0002 
Methoxychlor (72-43-5)................................           0.04   
Pentachlorophenol (87-86-5)...........................           0.001  
PCB's (as decachlorobiphenyl) (1336-36-3).............           0.0005 
Toxaphene (8001-35-2).................................           0.003  
2,4,5-TP (Silvex) (93-72-1)...........................           0.05   
------------------------------------------------------------------------

    (D) The allowable levels for certain chemicals for which EPA has 
established secondary maximum contaminant levels in its drinking water 
regulations (40 CFR part 143) are as follows:

                                                                        

[[Page 57127]]
------------------------------------------------------------------------
                                                        Concentration in
                      Contaminant                        milligrams per 
                                                              liter     
------------------------------------------------------------------------
Aluminum..............................................               0.2
Silver................................................               0.1
------------------------------------------------------------------------



    (E) Analyses to determine compliance with the requirements of 
paragraph (b)(4)(iii)(A) of this section shall be conducted in 
accordance with an applicable method and applicable revisions to the 
methods listed in paragraphs (b)(4)(iii)(E)(1) through 
(b)(4)(iii)(E)(13) of this section and described, unless otherwise 
noted, in ``Methods for Chemical Analysis of Water and Wastes,'' U.S. 
EPA, Environmental Monitoring and Support Laboratory (EPA-600/4-79-
020), March 1983, which is incorporated by reference in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are 
available from the National Technical Information Service, U.S. 
Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or 
may be examined at the Office of Plant and Dairy Foods and Beverages 
(HFS-305), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St., SW., Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (1) [Reserved]
    (2) Barium shall be measured using the following methods:
    (i) Method 208.2--``Atomic Absorption; furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (ii) Method 208.1--``Atomic Absorption; direct aspiration,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. The availability of this incorporation by reference is 
given in paragraph (b)(4)(iii)(A) of this section.
    (iii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in the 
manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' Office of Research and Development, 
Washington, DC 20460, (EPA/600/4-91/010), June 1991, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of this publication are available from the National 
Technical Information Service, U.S. Department of Commerce, 5825 Port 
Royal Rd., Springfield, VA 22161, or may be examined at the Office of 
Plant and Dairy Foods and Beverages (HFS-305), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 200 C St., SW., 
Washington, DC, or at the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC.
    (3) [Reserved]
    (4) Cadmium shall be measured using the following methods:
    (i) Method 213.2--``Atomic Absorption; furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. The availability of this incorporation by reference is 
given in paragraph (b)(4)(iii)(E) of this section.
    (ii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in the 
manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' Office of Research and Development,(EPA/600/4-
91/010), June 1991, which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this 
incorporation by reference is given in paragraph (b)(4)(iii)(E)(2)(iii) 
of this section.
    (5) Chromium shall be measured using the following methods:
    (i) Method 218.2--``Atomic Absorption; furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. The availability of this incorporation by reference is 
given in paragraph (b)(4)(iii)(E) of this section.
    (ii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in the 
manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' Office of Research and Development, (EPA/600/
4-91/010), June 1991, which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this 
incorporation by reference is given in paragraph (b)(4)(iii)(E)(1)(iii) 
of this section.
    (6) Copper shall be measured as total recoverable metal without 
filtration using the following methods:
    (i) Method 220.2--Atomic Absorption; furnace technique, in 
``Methods for Chemical Analysis of Water and Wastes,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 220.1--Atomic Absorption; direct aspiration, in 
``Methods for Chemical Analysis of Water and Wastes,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in the 
manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' Office of Research and Development, (EPA/600/
4-91/010), June 1991, which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are 
available from the National Technical Information Service, U.S. 
Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or 
may be examined at the Office of Plant and Dairy Foods and Beverages 
(HFS-305), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, or at the Office 
of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.
    (iv) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991. The revision is contained in the manual entitled ``Methods 
for the Determination of Metals in Environmental Samples,'' June 1991, 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. The availability of this incorporation by reference 
is given in paragraph (b)(4)(iii)(E)(7)(iii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Revision 
1.2, April 1991. The revision is contained in the manual entitled 
``Methods for the Determination of Metals in Environmental Samples,'' 
June 1991, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation 
by reference is given in paragraph (b)(4)(iii)(E)(2)(iii) of this 
section.
    (7) [Reserved]
    (8) Lead shall be measured as total recoverable metal without 
filtration using the following methods:
    (i) Method 239.2--Atomic Absorption; furnace technique, in 
``Methods for Chemical Analysis of Water and Wastes,'' which is 
incorporated by reference in accordance 

[[Page 57128]]
with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this 
incorporation by reference is given in paragraph (b)(4)(iii)(E)(2)(iii) 
of this section.
    (ii) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Revision 4.4, 
April 1991. The revision is contained in the manual entitled ``Methods 
for the Determination of Metals in Environmental Samples,'' June 1991, 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. The availability of this incorporation by reference 
is given in paragraph (b)(4)(iii)(E)(7)(iii) of this section.
    (iii) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 
1.2, April 1991. The revision is contained in the manual entitled 
``Methods for the Determination of Metals in Environmental Samples,'' 
June 1991, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation 
by reference is given in paragraph (b)(4)(iii)(E)(2)(iii) of this 
section.
    (9) Mercury shall be measured using the following methods:
    (i) Method 245.1--``Manual cold vapor technique,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 245.2--``Automated cold vapor technique,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E) of this section.
    (10) [Reserved]
    (11) Nitrate and/or nitrite shall be measured using the following 
methods:
    (i) Method 353.3--``Spectrophotometric cadmium reduction,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (ii) Method 353.2--``Colorimetric, automated, cadmium reduction,'' 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51.
    (iii) Method 300.0--``The Determination of Inorganic Anions in 
Water by Ion chromatography,'' which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this 
publication are available from the National Technical Information 
Service, Port Royal Rd., Springfield, VA 22161, or may be examined at 
the Office of Plant and Dairy Foods and Beverages (HFS-305), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 200 C 
St. SW., Washington, DC.
    (iv) Method 353.1--``Colorimetric, automated, hydrazine 
reduction,'' which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation 
by reference is given in paragraph (b)(4)(iii)(E) of this section.
    (12) Selenium shall be measured using the following methods:
    (i) Method 270.2--``Atomic Absorption; furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (ii) Method 270.3--``Atomic Absorption; gaseous hydride,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E) of this section.
    (13) [Reserved]
    (F) Analyses to determine compliance with the requirements of 
paragraphs (b)(4)(iii)(B) and (b)(4)(iii)(C) of this section shall be 
conducted in accordance with an applicable method or applicable 
revisions to the methods listed in paragraphs (b)(4)(iii)(F)(1) through 
(b)(4)(iii)(F)(20) of this section and described, unless otherwise 
noted, in ``Methods for the Determination of Organic Compounds in 
Drinking Water,'' Office of Research and Development, Environmental 
Monitoring Systems Laboratory EPA/600/4-88/039, December 1988, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of this publication are available from the National 
Technical Information Service, U.S. Department of Commerce, 5285 Port 
Royal Rd., Springfield, VA 22161, or may be examined at the Office of 
Plant and Dairy Foods and Beverages (HFS-305), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 200 C St. SW., 
Washington, DC, or at the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC.
    (1) Method 502.1--``Volatile Halogenated Organic Compounds in Water 
by Purge and Trap Gas Chromatography,'' Rev. 2.0, 1989, (applicable to 
VOC's), which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51, or
    (2) Method 502.2--``Volatile Organic Compounds in Water by Purge 
and Trap Capillary Column Gas Chromatography with Photoionization and 
Electrolytic Conductivity Detectors in Series,'' Rev. 2.0, 1989 
(applicable to VOC's), which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (3) Method 503.1--``Volatile Aromatic and Unsaturated Organic 
Compounds in Water by Purge and Trap Gas Chromatography,'' Rev. 2.0, 
1989 (applicable to VOC's), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (4) Method 524.1--``Measurement of Purgeable Organic Compounds in 
Water by Packed Column Gas Chromatography/Mass Spectrometry,'' Rev. 
3.0, 1989 (applicable to VOC's), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (5) Method 524.2--``Measurement of Purgeable Organic Compounds in 
Water by Capillary Column Gas Chromatography/Mass Spectrometry,'' Rev. 
3.0, 1989 (applicable to VOC's), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (6) Method 504--``1,2-Dibromoethane (EDB) and 1,2-Dibromo-3-
Chloropropane (DBCP) in Water by Microextraction and Gas 
Chromatography,'' Rev. 2.0, 1989 (applicable to dibromochloropropane 
(DBCP) and ethylene dibromide (EDB)), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (7) Method 505--``Analysis of Organohalide Pesticides and 
Commercial Polychlorinated Biphenyl (PCB) Products in Water by Micro-
Extraction and Gas Chromatography,'' Rev. 2.0, 1989 (applicable to 
alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, lindane, 
methoxychlor, toxaphene and as a screen for polychlorinated biphenyl's 
(PCB's)), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (8) [Reserved]
    (9) Method 507--``Determination of Nitrogen- and Phosphorus-
Containing Pesticides in Water by Gas Chromatography with a Nitrogen-
Phosphorus Detector,'' Rev. 2.0, 1989 (applicable to alachlor and 
atrazine), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (10) Method 508--``Determination of Chlorinated Pesticides in Water 
by Gas Chromatography with an Electron Capture Detector,'' Rev. 3.0, 
1989 (applicable to chlordane, heptachlor, heptachlor epoxide, lindane, 
methoxychlor, toxaphene, and as a screen for PCB's), which is 
incorporated 

[[Page 57129]]
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (11) Method 508A--``Screening for Polychlorinated Biphenyls by 
Perchlorination and Gas Chromatography,'' Rev. 1.0, 1989 (used to 
quantitate PCB's as decachlorobiphenyl if detected in methods 505 or 
508) in paragraph (b)(4)(iii)(F)(7) or (b)(4)(iii)(F)(9) of this 
section, respectively), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (12) Method 515.1--``Determination of Chlorinated Acids in Water by 
Gas Chromatography with an Electron Capture Detector,'' Rev. 5.0, May 
1991 (applicable to 2,4-D, 2,4,5-TP (Silvex) and pentachlorophenol), 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51, or
    (13) Method 525.1--``Determination of Organic Compounds in Drinking 
Water by Liquid-Solid Extraction and Capillary Column Gas 
Chromatography/Mass Spectrometry,'' Rev. 2.2, May 1991 (applicable to 
alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, lindane, 
methoxychlor, and pentachlorophenol), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (14) Method 531.1--``Measurement of N-Methylcarbamoyloximes and N-
Methylcarbamates in Water by Direct Aqueous Injection HPLC with Post 
Column Derivatization,'' Rev. 3.0, 1989 (applicable to carbofuran), 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. The availability of this incorporation by reference 
is given in paragraph (b)(4)(iii)(F) of this section.
    (15) [Reserved]
    (G) Analyses to determine compliance with the requirements of 
paragraph (b)(4)(iii)(D) of this section shall be conducted in 
accordance with an applicable method and applicable revisions to the 
methods listed in paragraphs (b)(4)(iii)(G)(1) and (b)(4)(iii)(G)(2) of 
this section and described, unless otherwise noted, in ``Methods of 
Chemical Analysis of Water and Wastes,'' which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The 
availability of this incorporation by reference is given in paragraph 
(b)(4)(iii)(E) of this section.
    (1) Aluminum shall be measured using the following methods:
    (i) Method 202.1--``Atomic Absorption; direct aspiration 
technique,'' which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51.
    (ii) Method 202.2--``Atomic Absorption; furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. The availability of this incorporation by reference is 
given in paragraph (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in 
``Methods for the Determination of Metals in Environmental Samples,'' 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. The availability of the incorporation by reference 
is given in paragraph (b)(4)(iii)(E)(2)(iii) of this section.
    (iv) Method 200.8--``Determination of Trace Elements in Waters and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991. The revision is contained in ``Methods for the 
Determination of Metals in Environmental Samples,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(iii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' Rev. 
1.2, April 1991. The revision is contained in ``Methods for the 
Determination of Metals in Environmental Samples,'' June 1991, which is 
incorporated by reference in accordance with 5. U.S.C. 552(a) and 1 CFR 
part 51. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(7)(iii) of this section.
    (2) Silver shall be measured using the following methods:
    (i) Method 272.1--``Atomic Absorption, direct aspiration,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (ii) Method 272.2--``Atomic Absorption, furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. The availability of this incorporation by reference is 
given in paragraph (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in 
``Methods for the Determination of Metals in Environmental Samples,'' 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. The availability of this incorporation by reference 
is given in paragraph (b)(4)(iii)(E)(1)(iii) of this section.
    (iv) Method 200.8--``Determination of Trace Elements in Waters and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4, 
April 1991. The revision is contained in ``Methods for the 
Determination of Metals in Environmental Samples,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(iii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' Rev. 
1.2, April 1991, in ``Methods for the Determination of Metals in 
Environmental Samples,'' which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(iii) of this section.
    (3) and (4) [Reserved]
    (5) Radiological quality. (i) Bottled water shall, when a composite 
of analytical units of equal volume from a sample is examined by the 
methods described in paragraph (b)(5)(ii) of this section, meet 
standards of radiological quality as follows:
    (A) The bottled water shall not contain a combined radium-226 and 
radium-228 activity in excess of 5 picocuries per liter of water.
    (B) The bottled water shall not contain a gross alpha particle 
activity (including radium-226, but excluding radon and uranium) in 
excess of 15 picocuries per liter of water.
    (C) The bottled water shall not contain beta particle and photon 
radioactivity from manmade radionuclides in excess of that which would 
produce an annual dose equivalent to the total body or any internal 
organ of 4 millirems per year calculated on the basis of an intake of 2 
liters of the water per day. If two or more beta or photon-emitting 
radionuclides are present, the sum of their annual dose equivalent to 
the total body or to any internal organ shall not exceed 4 millirems 
per year.
    (ii) Analyses conducted to determine compliance with paragraph 
(b)(5)(i) of this section shall be made in accordance with the methods 
described in the applicable sections of ``Standard Methods for the 
Examination of Water and Wastewater,'' 15th Ed. (1980), and ``Interim 
Radiochemical Methodology for Drinking Water,'' U.S. EPA, EMSL, 

[[Page 57130]]
EPA-600/4-75-008 (Revised), March 1976, both of which are incorporated 
by reference. The availability of these incorporations by reference is 
given in paragraph (b)(2) of this section.
    (c) Label statements. When the microbiological, physical, chemical, 
or radiological quality of bottled water is below that prescribed by 
paragraphs (b)(2) through (b)(5), of this section, the label shall bear 
the statement of substandard quality specified in Sec. 130.14(a) of 
this chapter except that, as appropriate, instead of or in addition to 
the statement specified in Sec. 130.14(a) the following statement(s) 
shall be used:
    (1) ``Contains Excessive Bacteria'' if the bottled water fails to 
meet the requirements of paragraph (b)(2) of this section.
    (2) ``Excessively Turbid'', ``Abnormal Color'', and/or ``Abnormal 
Odor'' if the bottled water fails to meet the requirements of paragraph 
(b)(3) (i), (ii), or (iii), respectively, of this section.
    (3) ``Contains Excessive ________,'' with the blank filled in with 
the name of the chemical for which a maximum contaminant level in 
paragraph (b)(4) of this section is exceeded (e.g., ``Contains 
Excessive Arsenic,'' ``Contains Excessive Trihalomethanes'') except 
that ``Contains Excessive Chemical Substances'' may be used if the 
bottled water is not mineral water.
    (4) ``Excessively Radioactive'' if the bottled water fails to meet 
the requirements of paragraph (b)(5) of this section.
    (d) Adulteration. Bottled water containing a substance at a level 
considered injurious to health under section 402(a)(1) of the act is 
deemed to be adulterated, regardless of whether or not the water bears 
a label statement of substandard quality prescribed by paragraph (c) of 
this section.

PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

    7. The authority citation for 21 CFR part 184 continues to read as 
follows:


    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).


    8. Section 184.1563 is amended by revising paragraph (c) to read as 
follows:


Sec. 184.1563  Ozone.

* * * * *
    (c) In accordance with Sec. 184.1(b)(2), the ingredient is used to 
treat food only within the following specific limitations:

------------------------------------------------------------------------
                                Maximum treatment                       
      Category of food            level in food        Functional use   
------------------------------------------------------------------------
Bottled water that prior to   Not to exceed         Antimicrobial agent,
 ozonation meets the           current good          Sec.  170.3 (o)(2) 
 microbiological, physical,    manufacturing         of this chapter.   
 chemical, and radiological    practice. Current                        
 quality standards of Sec.     good manufacturing                       
 165.110 (b)(2) through        practice results in                      
 (b)(5) of this chapter.       a maximum residual                       
                               level at the time                        
                               of bottling of 0.4                       
                               milligram of ozone                       
                               per liter of                             
                               bottled water.                           
------------------------------------------------------------------------

    Dated: November 3, 1995.
William K. Hubbard,
Acting Duputy Commissioner for Policy.
[FR Doc. 95-27798 Filed 11-7-95; 8:45 am]
BILLING CODE 4160-01-P