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. 
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: (Insert date 180 days after date of publication 
in the FEDERAL REGISTER.) 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 180 days after date 
of publication in the 
FEDERAL REGISTER. 
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 
 165.110(a) for bottled water (hereinafter referred to as the 
January 1993 proposal). At the same time, the agency proposed to 
recodify in  165.110(b), (c), and (d), the standard of quality 
for bottled water currently found in  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  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 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, 
 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  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  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  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 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  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" 
( 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 
( 165.110(a)(1)). Although  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 
 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  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 found in part 129 and 
 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 
 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  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 
( 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  165.110(a)(1) within the limitations established in the 
quality standard ( 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  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 
 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 
 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  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  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 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  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 
 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 
 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 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  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  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 
 165.110(a)(2), it is recodifying the other terms in 
 165.110(a)(2) so that they continue to appear in alphabetical 
order.) The agency is also requiring in  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 
 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  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 
 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 
 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  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 
 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 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  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) 
( 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 
 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 
 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 
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  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 record
s 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 
 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  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. 
 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 
 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 
 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 
 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, 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 
 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 
 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 
 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 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 
 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  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  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 ( 101.9(c)(8)). 
The reference amount customarily consumed for bottled water is 
240 milliliter (mL) ( 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  101.65(b)(4)). For example, when 
the name of the ingredient constitutes the common or usual name 
of the product, as described in  102.5 (21 CFR 102.5), or the 
identity of the commodity, as described in  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 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 ( 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  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  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 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" 
( 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 name 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 
 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  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 reco
mmended 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 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 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 
 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 
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 
 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  129.3(a), an approved source is one that has 
been inspected by the State and local government agencies having 
jurisdiction. Under  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 
 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 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  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,  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 in 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 
 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  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 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  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  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 ( 165.110(a)(2)(vi)). 
The agency 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  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 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  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  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 requi
re 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  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  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 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 
 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  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  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 ( 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 
 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  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  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. 
 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  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  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  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 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  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 ( 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  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  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  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  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), that fact 
must be included in the statement of identity of the product as 
well (e.g., demineralized) ( 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 
 165.110(a)(2)(viii) as a result of the additions that FDA has 
made to  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  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, 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  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  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 ( 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  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  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 1500 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 1500 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. 
 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  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 
 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 
 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  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 1500 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  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 ruling that a 
mineral water with a TDS higher than 1500 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 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  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 1500 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 
 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 als
o 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  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  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). 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 in
corporated 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  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  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 
 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  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  165.110(a)(3)(ii) to include all 
of the terms that may be used under  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 
 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  165.110(a)(3)(ii). Sterile water has 
undergone a treatment to meet strict microbiological standards. 
Purified water is exempt from the requirements of 
 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 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  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 d
oes 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  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 
 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  165.110(a)(3)(ii). 
 78. Several comments stated that FDA has not provided, 
except in  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  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 
 165.110(a)(2)(iv), and is labeled as "purified water" or one of 
its alternative names, is exempt from the labeling requirements 
of  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  165.110(a)(3)(ii) because the water ingredient 
meets the criteria for the exemption. 
 79. Some comments agreed with the requirement in 
 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 
( 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 ( 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  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 would. 
According to  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  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 artic
ulated 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  113.3(e), and the agency sees no reason 
to subject bottled water for infants to stricter requirements. 
Therefore, the agency is modifying  165.110(a)(3)(iii) to state 
that its provisions apply when the product is not commercially 
sterile under  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  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  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 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  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 
 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  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,  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  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 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 regards 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  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 ( 165.110(b)(4)(iii)(A)). Bottled 
water exceeding these levels must be labeled as substandard under 
 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 th
e 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 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  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  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 
 103.35(a)(1) to  165.110(a)(1) and the standard of quality for 
bottled water from  103.35 to  165.110. The agency also 
proposed to include existing definitions for "lot," "sample," and 
"analytical unit" found in  103.3 in part 165. Because FDA was 
proposing to remove the quality standard from  103.35 and 
include it in  165.110, FDA tentatively concluded that the 
definition of these terms should be moved as well. 
 87. One comment objected to a provision in  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  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. 
 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  165.110(b)(4) (see footnote 1 to 
 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. Giv
en 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 
 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  165.110(b)(3) and  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  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 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 
 165.110(b)(4)(ii) must bear the statement "contains excessive 
fluoride" in accordance with  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 
 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. 
 The agency disagrees with the request that it require, at a 
minimum, that the specific chemical substances that exceed the 
maximum allowable levels in  165.110(b)(4) to be listed on the 
label instead of providing the exception in  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  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  129.35 and to delete the exclusion for mineral 
water from testing requirements in  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 
 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 ( 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 
 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 
 129.35(a)(4)(i) to include firms that use a public water system 
for source water and  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  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 ( 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 
 165.110(b) or be labeled as substandard in accordance with 
 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  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 
"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  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  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  129.80(g). The testing exemptions for 
microbiological contaminants that FDA established previously 
( 129.35(a)(3)(i)) and for chemical contaminants that FDA is 
establishing in this rulemaking ( 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  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  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  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  129.35(a)(4) in no way changes how product water 
and finished product water are to be tested. 
 101. Two comments objected to  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 
 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  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  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  129.35(a)(4) applies only to source 
water testing, and that the product water must be tested in 
accordance with  129.80(a). Moreover, the finished product must 
be tested for all substances in accordance with  129.80(g). 
Thus, FDA concludes that no modification of  129.35(a)(4)(ii) is 
warranted. 
 102. One comment recommended that  129.35(a)(4)(ii) be 
modified to require that at least two complete samples for 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  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  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  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  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  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 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  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  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 
 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 
( 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  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 addit
ional 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  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  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,  129.80(f) requires that only nontoxic containers 
and closures be used. "Nontoxic materials" is defined in 
 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  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 
 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,  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 
 165.110(b)(2). Manufacturers must ensure that bottled water 
meets the microbiological quality standards in  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 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 
 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  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  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 
 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  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 
( 129.35(a)(3)), as often as necessary for product water 
( 129.80(a)), and at least once a week for the finished product 
( 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  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 
 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  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 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 
 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 ( 129.80(a)). 
 The compliance procedures for the finished product are set 
forth in  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  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 ( 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 an
d 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  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  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  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  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 
 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 
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 fo
r 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 
 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  101.9. 
 The agency points out that although the term "salt" is not 
synonymous with "sodium," salt refers to sodium chloride. Under 
 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  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 i
n 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 effort
s 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 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  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  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 bot
tled 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, i
s 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 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 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 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 wi
th 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 
 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  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: 
 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  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). 
 * * * * * 
 (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 
 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: 
 129.80 Processes and controls. 
 * * * * * 
 (g) Compliance procedures. A quality standard for bottled 
drinking water is established in  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 
 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 
 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  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 min
erals 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." Sprin
g 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 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  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: 
 
 
 SUBSTANCE 
 CONCENTRATION 
 IN MILLIGRAMS 
 PER LITER 
 
 
 Arsenic......................................... 
 Chloride1....................................... 
 Iron1........................................... 
 Manganese1...................................... 
 Phenols......................................... 
 Sulfate1........................................ 
 Total dissolved solids1......................... 
Zinc........................................... 
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).......... 
 Total Trihalomethanes...................... 
 0.05 
 250.0 
 0.3 
 0.05 
 0.001 
 250.0 
 500.0 
 5.0 
 
 
 
 0.0002 
 0.10 
 
 (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 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, Subpa
rt 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 
 concentration 
 Annual average of maximum daily air in 
 temperatures (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 
 concentration 
 Annual average of maximum daily air in 
 temperatures (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: 
_________________________________________________________________ 
Contaminant Concentration milligrams 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 Ni- 
 trite............ 10 (as nitrogen) 
Selenium........... 0.05 
_________________________________________________________________ 
 (B) The allowable levels for volatile organic chemicals 
(VOC's) are as follows: 
_________________________________________________________________Contaminant (CAS Reg. No.) 
 Concentration in 
 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: 
_________________________________________________________________ 
Contaminant (CAS Reg. No.) Concentration in 
 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: 
_________________________________________________________________ 
 Contaminant Concentration in 
 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 FEDE
RAL 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 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 198
8, 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 (applicabl
e 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 Mi
croextraction 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 G
as 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 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 exces
s 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, 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  130.14(a) of this chapter except that, as 
appropriate, instead of or in addition to the statement specified 
in  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: 
 184.1563 Ozone. 
 * * * * * 
 (c) In accordance with  184.1(b)(2), the ingredient is 
used to treat food only within the following specific 
limitations: 
 Maximum 
 Category of food treatment level in Functional use 
 food 
 
Bottled water that Not to exceed Antimicrobial 
 prior to ozonation current good agent,  170.3 
 meets the manufacturing (o)(2) of this 
 microbiological, practice. chapter. 
 physical, Current good 
 chemical, and manufacturing 
 radiological practice results 
 quality standards in a maximum 
 of  165.110(b)(2) residual level at 
 through (b)(5) of the time of 
 this chapter. bottling of 0.4 
 milligram of 
 ozone per liter 
 of bottled water. 
 
 
 
 
 
 
Dated: . 
 
 
 
 
 
 
[BILLING CODE 4160-01-F|