[Federal Register Volume 60, Number 218 (Monday, November 13, 1995)]
[Rules and Regulations]
[Pages 57076-57130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27798]
[[Page 57075]]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 103 et al.
Beverages: Bottled Water; Final Rule
Federal Register / Vol. 60, No. 218 / Monday, November 13, 1995 /
Rules and Regulations
[[Page 57076]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 103, 129, 165, and 184
[Docket No. 88P-0030]
RIN 0910-AA11
Beverages: Bottled Water
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is establishing a
standard of identity for bottled water. At the same time, the agency is
recodifying the standard of quality for bottled water. FDA is revising
the definition for bottled water in the quality standard to include
mineral water and ingredient uses of this product. In addition, FDA is
defining ``artesian water,'' ``ground water,'' ``mineral water,''
``purified water,'' ``sparkling bottled water,'' ``spring water,''
``sterile water,'' and ``well water.'' FDA is exempting mineral water
from certain physical and chemical allowable levels. FDA is taking
these actions, in part, in response to a petition submitted by the
International Bottled Water Association (IBWA). FDA finds that the
regulations will promote honesty and fair dealing in the interest of
consumers as well as the interests of the regulated industry.
EFFECTIVE DATE: May 13, 1996. The Director of the Office of the Federal
Register approves the incorporations by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51 of certain publications at 21 CFR
129.35(a)(3)(ii), 129.80(g), and 184.1563(c), effective May 13, 1996.
FOR FURTHER INFORMATION CONTACT: Shellee A. Davis, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4681.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 5, 1993 (58 FR 393), FDA
published a proposal to establish a standard of identity in
Sec. 165.110(a) for bottled water (hereinafter referred to as the
January 1993 proposal). At the same time, the agency proposed to
recodify in Sec. 165.110 (b), (c), and (d), the standard of quality for
bottled water currently found in Sec. 103.35. FDA proposed to revise
the definition for bottled water in the quality standard to include
mineral water and ingredient uses of this product. In addition, FDA
proposed to define ``artesian water,'' ``distilled water,'' ``mineral
water,'' ``purified water,'' ``spring water,'' and ``well water.'' FDA
proposed to exempt mineral water from certain physical and chemical
allowable levels if the mineral water contained total dissolved solids
(TDS) in excess of 500 parts per million (ppm). Interested persons were
given until March 8, 1993, to submit comments.
In the Federal Register of March 9, 1993 (58 FR 13041), FDA
extended the comment period to April 7, 1993. In addition, the agency
reopened the comment period for comments concerning two spring water
surveys that FDA received in response to the proposal (58 FR 34010,
June 23, 1993). Interested persons were given until July 23, 1993, to
submit comments concerning the two spring water surveys.
FDA received approximately 430 responses, each of which contained
one or more comments, from trade and retail associations, government
organizations, manufacturers, consumers, health care professionals,
retailers, consumer groups, State groups, private organizations, the
U.S. Congress, professional societies, and universities. The comments
generally supported the proposal. Several comments addressed issues
outside the scope of the proposal (e.g., microbiological quality
standards, definitions for multicomponent bottled water beverages) that
will not be discussed here. A number of comments suggested
modifications and revisions in various provisions of the proposal. A
summary of the suggested changes and the agency's responses follow.
Elsewhere in this issue of the Federal Register, FDA is proposing
to update the methods referenced in Sec. 165.110(b)(3) and to exempt
mineral water from the allowable level for aluminum in the quality
standard. FDA is responding to the comments on the January 1993
proposal that addressed those issues in that proposal.
II. The Standard of Identity
A. Coverage
The agency proposed in the January 1993 proposal, to move the
definition for bottled water from the quality standard to the standard
of identity and to revise the definition to include mineral water and
ingredient uses of bottled water. Specifically, FDA proposed that
bottled water be defined as water that is intended for human
consumption and that is sealed in bottles or other containers with no
added ingredients, except that it may contain safe and suitable
antimicrobial agents. The agency also proposed that bottled water may
be used as an ingredient in beverages (e.g., diluted juices, flavored
bottled water) but stated that the term did not cover those food
ingredients that are declared in ingredient labeling as ``water,''
``carbonated water,'' ``disinfected water,'' ``filtered water,''
``seltzer water,'' ``soda water,'' and ``tonic water.'' Finally, FDA
proposed that the processing and bottling of bottled water must comply
with applicable regulations in part 129 (21 CFR part 129).
1. One comment asked why bottled water is singled out for a source
identification requirement (e.g., water from a municipal source), and
why soft drinks, beers, reconstituted juices, salad dressings, and
other products that contain water as an ingredient are not also subject
to this requirement.
The agency considered the scope of the bottled water standard,
particularly its application to water used as an ingredient in
multicomponent foods such as flavored waters and diluted juices, in the
proposal to this final rule (58 FR 393 at 395). FDA stated that
highlighting the water component of these products is effectively a
claim that the water ingredient in the beverage has particular value,
and that consumers are likely to purchase these products in large
measure because of the claim concerning the water ingredient. For
example, in a significant number of situations, the labeling of
products stated or implied that the water originated from a source such
as a spring or a well. In contrast, in products such as soft drinks or
reconstituted juices in which water is simply used as an ingredient, no
claim is made about the water. The intent of the proposal was not to
require source labeling of all water ingredients from a municipal
source, but to require it in the former type of situation, where the
finished product is bottled water or the labeling makes an explicit or
implied claim concerning the water ingredient.
Under section 403(a) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 343(a)), a product is misbranded if its labeling
is false or misleading in any particular. To determine whether the
absence of information on food labels constitutes misbranding the
agency must take into account the extent to which the labeling fails to
reveal facts material in light of representations made or suggested
with respect to consequences that may result from the use of the
article under customary or usual conditions of use (section 201(n) of
the act (21 U.S.C. 321(n))). The agency does not deem
[[Page 57077]]
source labeling of ingredient water from a municipal source as a
material fact unless labeling representations are made or suggested
that the water possesses particular properties.
Thus, the agency finds no reason to include water that is not a
highlighted ingredient in the bottled water standards, and the comment
has not provided a basis to do so. Therefore, Sec. 165.110 applies only
to bottled water and ingredient uses of water where the water
ingredient is highlighted in the labeling.
2. Two comments expressed concern about sparkling water being
regulated under the bottled water standards. They stated that sparkling
water has long been understood by consumers and recognized by FDA as a
common or usual name for unsweetened and unflavored water containing
compressed carbon dioxide. The comments contended that consumers
clearly understand ``sparkling water'' to be in the same category as
``carbonated water,'' ``seltzer water,'' ``soda water,'' and ``tonic
water,'' substances that historically have been regulated by FDA as
``soft drinks.'' They stated that as such, ``sparkling water'' is more
appropriately classified as a ``soft drink'' that is not subject to the
proposed bottled water standard.
Some comments stated that it was unclear whether ``sparkling
water'' was included under the exemption for ``carbonated water'' and
asked for clarification. One comment stated that if the standard does
not encompass the term, FDA should include ``sparkling water'' in the
definition of bottled water.
FDA stated in the preamble to the proposed rule that when a
beverage is labeled as containing ``water,'' ``carbonated water,''
``disinfected water,'' ``filtered water,'' ``seltzer water,'' ``soda
water,'' and ``tonic water,'' there is no claim that the water
ingredient has particular value, and that, thus, these ingredients were
not included in the definition of bottled water (58 FR 393 at 395).
This proposed exclusion did not extend to the term ``sparkling water''
or to any other term not specifically excluded by the standard. In the
proposal, the agency used the example of the term ``sparkling'' as
indicating that the water ingredient possessed a specific
characteristic or had received a specific treatment (id.). FDA
tentatively concluded at that time that use of such highlighted terms
concerning the water component was effectively a claim that the water
ingredient in the beverage had particular value, and that consumers
were likely to purchase these beverages in large measure because of the
claim.
The agency notes, however, that sparkling water was included in the
former soda water standard. In the Federal Register of February 16,
1967 (32 FR 2940), the agency amended the soda water standard to add
the term ``sparkling water'' to the standard as an example of a type of
soda water generally designated by a particular common name. FDA
proposed this change to permit the designation of nonsweetened and
nonflavored soda water by names other than those prescribed in the
standard (31 FR 11109, August 20, 1966). However, FDA repealed the
standard of identity for soda water in the Federal Register of January
6, 1989 (54 FR 398) because some provisions of the standard were being
adequately dealt with by other regulations, while other provisions were
no longer necessary.
Given the traditional use of this term, as evidenced by the
repealed standard, the agency agrees that the term ``sparkling water''
describes a nonsweetened and nonflavored carbonated water, and that it
thus, is a term that is synonymous with the term ``carbonated water.''
The fact is that the agency had separate standards at one time for
bottled water and for soda water, and that it included sparkling water
in the soda water, and not the bottled water standard. Therefore, the
comments have persuaded the agency that some types of sparkling water
are in the same category as ``carbonated water,'' ``seltzer water,''
``soda water,'' and ``tonic water,'' and should be regulated as a soft
drink instead of as a bottled water. Accordingly, the bottled water
standard in Sec. 165.110 does not include those food ingredients that
are declared in ingredient labeling as ``water,'' ``carbonated water,''
``disinfected water,'' ``filtered water,'' ``seltzer water,'' ``soda
water,'' ``sparkling water'' (except as explained in this response) and
``tonic water.''
However, the term ``sparkling water'' may also refer to water that
is naturally carbonated (i.e., contains carbon dioxide as it emerges
from the source) and that is labeled as ``sparkling water.'' The
bottled water standard has traditionally included this type of water
because the water has not been carbonated in the same sense that a soda
water is carbonated (i.e., with added carbon dioxide). Thus, water that
contains carbon dioxide as extracted from the source is not a soda
water and must continue to be regulated as a bottled water. Therefore,
to differentiate between the two types of sparkling waters, the agency
is defining ``sparkling bottled water'' in Sec. 165.110(a)(2)(v) as
bottled water that, after treatment and possible replacement of carbon
dioxide, contains the same amount of carbon dioxide that it had at
emergence from the source. This definition is in accordance with the
definition in the European Regional Codex Standard (ERCS) for
``naturally carbonated natural mineral water'' (Ref. 1).
The agency concludes that defining the term ``sparkling bottled
water'' is within the scope of this rulemaking because FDA proposed
that sparkling water be included under the bottled water standard. As a
consequence of proposing that course of action, FDA has been persuaded
that some types of sparkling water should be excluded from the standard
and that it should differentiate among the types of sparkling water in
its bottled water regulations.
3. Two comments objected to the exclusion of carbonated bottled
waters from the bottled water standards. They stated that any product
that professes to be, or that has as an important ingredient that is
one of the defined bottled water types (e.g., spring water, mineral
water), whether noncarbonated or carbonated, should be considered to be
bottled water. The comments contended that only those carbonated
products with respect to which no reference is made to defined bottled
water types should be excluded.
The agency agrees with the comment. Products or ingredients
described by a term that is defined by the standard of identity (e.g.,
``spring water'') or with a term that makes a claim about the water
(e.g., ``natural water'') are standardized waters and must comply with
Sec. 165.110 whether carbonation has been added or not. Although terms
to describe the water ingredient in a product may sometimes be used in
combination with a term that is not included under the standards (e.g.,
``carbonated spring water'' or ``filtered natural water''), the product
or the water ingredient in the product must comply with the bottled
water standards because a claim is being made concerning the value of
the water. However, use of only a term specifically excluded from the
bottled water standards (e.g., ``filtered water'' or ``carbonated
water'') means that no claim is being made concerning the value of the
water, and, thus, the water is not a standardized food.
4. Several comments stated that it is inconsistent for FDA to
exempt carbonated waters from the bottled water standards. They held
that carbonated water may be consumed at levels which constitute a
major portion of an individual's daily water intake. One comment added
that exempting
[[Page 57078]]
carbonated water from the bottled water category does not provide for
consumer safety or confidence.
The agency does not agree with the comments, although it
acknowledges that carbonated waters may constitute a major portion of
some consumers' daily water intake. However, FDA points out that
standards of identity and quality are not established because a product
is consumed in large volumes or for consumer safety or confidence but
are established to promote honesty and fair dealing in the interest of
consumers.
``Carbonated water'' or ``soda water'' has traditionally not been
covered by the provisions of the bottled water quality standard because
it has been considered to be a soft drink. Bottled water and soda
water, although similar, are two different foods as evidenced by the
fact that the agency had quality standards for bottled water at the
same time that it had a standard of identity for soda water that
included ``carbonated water.''
FDA tentatively concluded in the proposal that it would not include
``carbonated water'' in the standards for bottled water because it has
historically not been considered to be bottled water. In addition, the
agency tentatively concluded that the standards for bottled water
covered water ingredients that were highlighted because of a claim
concerning the water ingredient itself.
Labels of foods that claim to contain as an ingredient, or to be,
``carbonated water'' do not claim or imply any particular properties or
characteristics for the water ingredient. Any claims on such foods for
the ingredient are simply that carbon dioxide has been added. Thus,
``carbonated water'' does not fit within the type of food that the
bottled water standard is intended to address because no claim is being
made about the water itself. The agency finds no reason to include
``carbonated water'' in the bottled water standard, and the comment has
not provided any basis to do so. Therefore, the agency concludes that
it has not been inconsistent in the regulation of ``carbonated water''
and ``bottled water.''
5. Two comments stated that the terms ``carbonated water,''
``disinfected water,'' ``filtered water,'' ``seltzer water,'' ``soda
water,'' and ``tonic water'' should be defined to avoid confusion by
industry and consumers as to what types of water are covered by the
bottled water standards and what types of water are not. One of the
comments stated that these terms may have different meanings to the
bottled water and beverage industries and consumers.
The agency does not agree with the comments. There is general
understanding of the meanings of these terms, even though they are not
defined in FDA's regulations. ``Carbonated water,'' ``disinfected
water,'' ``filtered water,'' ``seltzer water,'' ``soda water,'' and
``tonic water'' are common or usual names that are in general use by
both manufacturers and consumers. In the proposal to this final rule
(58 FR 393 at 395), the agency noted that the terms ``carbonated
water,'' ``seltzer water,'' ``soda water,'' and ``tonic water'' have
historically been considered to be soft drinks, and that ``disinfected
water'' and ``filtered water'' described water that has been subjected
to a commonly used treatment.
The reason for not addressing these terms under the bottled water
standard is that they make no claims about the water used in the
ingredients that they denominate. The exclusion is not based on the
specific source, composition, or processing of these types of waters.
The comments did not provide any information to persuade the agency to
conclude otherwise. Therefore, FDA is not defining these common terms
at this time. However, persons interested in establishing definitions
for ``carbonated water,'' ``disinfected water,'' ``filtered water,''
``seltzer water,'' ``soda water,'' and ``tonic water'' may petition the
agency to do so, providing recommended definitions and justification
for the recommendations.
6. Several comments objected to any definition of bottled water
that does not allow for the addition of ingredients such as minerals
for flavor, flavors that comprise less than 1 percent by weight of the
product, and carbon dioxide. They stated that changing the definition
of bottled water to exclude established products would: (1) Be costly
to the bottled water industry; (2) exempt excluded bottled water
products from meeting FDA's proposed health, safety, and quality
standards; and (3) confuse rather than unify regulatory authority. One
comment declared that it is imperative that the final regulation
include all established products of the bottled water industry.
One comment stated that some model codes and State regulations
provide for the addition of ingredients to bottled water provided that
these additives comprise less than 1 percent by weight of the final
product. The comment noted that many consumers may supply a major
portion of their daily water intake needs with these 1 percent bottled
water products.
Another comment noted that Sec. 129.80(a) states that carbonation,
mineral addition, or any other process shall be done in a manner so as
to be effective in accomplishing its intended purpose and in accordance
with section 409 of the act. It stated that there is no reason to
disallow any of these processes or their resultant products as bottled
water.
FDA does not agree that it is changing the definition of bottled
water. The agency acknowledges that some State regulations define
bottled waters with added flavors, minerals, and carbon dioxide as
described in the comments (Ref. 2). However, the Federal definition of
``bottled water'' has traditionally been ``water that is sealed in
bottles or other containers and that is intended for human
consumption'' (Secs. 103.35(a)(1) and 129.3(b) (1994)). This definition
is the basis of the definition that FDA is adopting in this final rule
(Sec. 165.110(a)(1)). Although Sec. 129.80(a) mentions treatment of
product water with carbonation and mineral addition, among other
processes, any bottled water product with added ingredients would be
just that--bottled water with added ingredients. (However, see the
discussion of fluoride in bottled water in comment 8 of this document.)
Firms may manufacture nonstandardized bottled water products with
ingredients such as minerals for flavor, flavors that comprise less
than 1 percent by weight of the product, and carbon dioxide added to
bottled water. The common or usual name of the resultant product must
reflect these additions. However, only the bottled water ingredient is
subject to the standard in Sec. 165.110. The other ingredients in the
product are subject to regulation under the food additive or other food
ingredient provisions of the act. Thus, it is not necessary to include
added ingredients, such as minerals for flavor, flavors that comprise
less than 1 percent by weight of the product, or carbon dioxide, in the
standard for bottled water.
Therefore, for the reasons listed above the agency is not persuaded
by the comments to include the addition of minerals, flavors, and
carbon dioxide in the standard of identity for bottled water in
Sec. 165.110(a)(1).
7. One comment stated that all bottled waters imported into the
United States should meet all of FDA's requirements for bottled waters
including mineral water. It added that U.S. standards should not be
lessened to meet European standards unless there are compelling public
health reasons for doing so.
FDA agrees that both foreign and domestic bottled waters sold in
interstate commerce in the United States must comply with the act and
the regulations issued thereunder, including the specific regulations
for bottled water
[[Page 57079]]
found in part 129 and Sec. 165.110. Although the agency attempts, where
possible, to harmonize its regulations with the regulations of other
countries, there must be appropriate grounds for FDA to amend any of
its bottled water regulations, whether or not such action would
harmonize international standards.
B. Fluoridated Water
The agency did not propose a definition for ``fluoridated water,''
although it did request comments on the need to define types of bottled
water other than those for which it proposed definitions. Some comments
addressed issues on fluoridated water that fall within the scope of
this rulemaking. Therefore, the agency is addressing these issues in
this final rule.
8. Several comments stated that the addition of fluoride to bottled
water should be allowed. One comment noted that many people
specifically request and use fluoridated water because of its benefits
to dental health. The comment stated that these products have long been
established and should not be discontinued. One comment noted an
inconsistency between the definition of bottled water and the
provisions of proposed Sec. 165.110(b)(4)(ii) that discuss the addition
of fluoride.
FDA agrees that there is an inconsistency between the proposed
standard of identity and the standard of quality for bottled water with
respect to the addition of fluoride. The agency proposed in
Sec. 165.110(a)(1) that bottled water contain no added ingredients
other than safe and suitable antimicrobial agents. This provision would
preclude the addition of fluoride (58 FR 393 at 407). The quality
standard, however, provides maximum levels for bottled water to which
fluoride is added (Sec. 165.110(b)(4)(ii)).
The agency recognizes that water with fluoride added may provide a
benefit to consumers. The Surgeon General's Report on Nutrition and
Health (the Surgeon General's report) recommends that community water
systems contain fluoride at optimal levels for prevention of tooth
decay, and that, if such water is not available, other appropriate
sources of fluoride should be used (Ref. 3). Bottled water may be used
by some consumers as an alternative to community drinking water.
Therefore, because of the unique circumstances presented by fluoride,
the agency is providing for the optional addition of fluoride to
bottled water in Sec. 165.110(a)(1) within the limitations established
in the quality standard (Sec. 165.110(b)(4)(ii)).
Because the agency is providing for the optional addition of
fluoride to bottled water, the standardized product may be a
multiingredient food, and, as such, its label must bear ingredient
labeling. According to Sec. 101.4(a)(1) (21 CFR 101.4(a)(1)), all food
ingredients are required to be declared on the label. Therefore,
bottled water containing added fluoride must list the names of the
water ingredient and the fluoride.
Therefore, because FDA is providing for the optional addition of
fluoride to bottled water, and thus, bottled water may be a
multicomponent food, the agency is adding Sec. 165.110(a)(4) to require
that each of the ingredients used in the food be declared on the label
as required by the applicable sections of 21 CFR parts 101 and 130.
9. Several comments requested that FDA define ``fluoridated
water.'' Some of these comments recommended that ``fluoridated water''
be defined as bottled water containing naturally occurring or added
fluoride, and that the label specify whether fluoride is naturally
occurring or added. One comment stated that the regulation only
discusses maximum limits on fluoride addition without setting a
minimum, thus opening a loophole that would allow manufacturers to add
insignificant amounts of fluoride to their products and call them
``fluoridated water.'' One comment stated that any water that is called
``fluoridated water'' should contain not less than 0.8 milligram per
liter (mg/L) fluoride ion. Another comment stated that any water that
is defined as ``fluoridated water'' should contain not less than 1.0
mg/L fluoride. One comment requested that ``fluoridated water'' be
defined only as water containing added fluoride.
FDA has provided for the use of the terms ``fluoridated,''
``fluoride added,'' and ``with added fluoride'' on the label or in
labeling of bottled water that contains added fluoride in
Sec. 101.13(q)(8). The agency adopted this regulation in the Federal
Register of January 6, 1993 (58 FR 2302 at 2314) and stated that the
presence of fluoride in bottled water is of interest to consumers, and
its declaration should not be prohibited. However, the agency also
stated that it did not wish to encourage unnecessary addition of
fluoride to bottled water, and that it was concerned that if it
permitted the use of terms like ``good source of fluoride'' or ``high
in fluoride,'' they might encourage such additions. Therefore, the
agency has not defined a nutrient content claim for fluoride. Instead,
it has provided that a statement indicating the presence of added
fluoride could be used, but that the claim cannot include a description
of the level of fluoride present.
As stated in another final rule in the Federal Register of January
6, 1993 (58 FR 2079 at 2149), the agency has considered the identity
statement ``fluoridated water'' to be misleading if the product is
derived from a source naturally containing fluoride. Because the term
``fluoridated'' represents that fluoride has been added to the water,
FDA concluded that the term ``fluoridated water'' should be used to
describe only products to which fluoride has been added in the
manufacturing process, and that such products would be required to bear
nutrition labeling that complies with the simplified format (id.). FDA
also points out that fluoride may not be present in amounts that exceed
the limits in Sec. 165.110(b)(4)(ii).
Although labeling could be used to describe whether fluoride was
added or naturally present in bottled water, the term ``fluoridated''
continues to mean that fluoride has been added. FDA is not establishing
a minimum level for fluoride addition because the terms
``fluoridated,'' ``fluoride added,'' or ``with added fluoride'' have
been defined in Sec. 101.13(q)(8) and amending that provision falls
outside the scope of this final rule. However, if the addition of
fluoride to water is so minimal that it would be considered dietarily
insignificant, a product that bears a claim about such addition would
be misbranded under section 403(a) of the act in that its labeling
would be misleading because the use of the term ``fluoridated'' or any
of its synonyms implies that fluoride has been added in a meaningful
amount. Thus, FDA concludes that it has not created a loophole that
would allow manufacturers to add insignificant amounts of fluoride to
their products and call them ``fluoridated water.''
The Surgeon General's Report states that the optimal fluoride
concentration of approximately 1 ppm fluoride has been shown to reduce
the prevalence of dental caries by more than 50 percent (Ref. 3). In
addition, the Surgeon General's Report states that current
recommendations for optimum fluoride concentrations vary from 0.7 to
1.2 ppm (id.). Therefore, the comments' suggested values of 0.8 mg/L
and 1.0 mg/L fluoride are meaningful amounts of this mineral in bottled
water.
10. One comment stated that infant bottled waters may contain
fluoride, and that the presence of this mineral may be a problem if
parents are not aware that too much fluoride is undesirable, or that an
infant should not receive both a physician's prescription of fluoride
[[Page 57080]]
drops and drink water containing fluoride. For this reason, the comment
stated that the label of a bottled water containing 0.3 ppm or more
fluoride should include a statement advising parents not to use the
product before consulting with their baby's physician if the baby is
receiving a fluoride supplement. The comment added that bottled water
for general use is also used for infants, so such a label statement
should be required on any bottled water containing 0.3 ppm or more
fluoride. It stated that this level of fluoride is taken from the
current recommendation of pediatricians and pediatric dentists relating
to administration of fluoride supplements. It suggested that the
statement could read as follows: ``Note: If you are giving your baby a
fluoride supplement, do not use water with fluoride without consulting
your doctor.''
The agency agrees that an advisory statement such as that suggested
by the comment may be appropriate to prevent unwanted aesthetic effects
from excessive doses of fluoride, and it encourages manufacturers to
provide such information to consumers, especially on products labeled
for infant use. However, FDA does not agree that this statement should
be mandatory on all bottled waters containing 0.3 ppm or more fluoride.
There are allowable levels for fluoride in the quality standard, and
bottled water exceeding these levels must be labeled as substandard.
The allowable levels are related to secondary levels established by the
Environmental Protection Agency (EPA) for public drinking water in 40
CFR parts 141 and 143 and take into consideration excessive infant
fluoride intake. In addition, as discussed in the previous comment, the
Surgeon General's Report recommends an optimal level of 1.0 ppm
fluoride in drinking water.
Fluoride supplements are generally prescribed for breast-fed
infants because those infants frequently consume little or no water.
Human milk contains little fluoride, even in areas with fluoridated
water supplies. Physicians may also prescribe fluoride supplements for
infants not receiving adequate dietary fluoride. Health care
professionals must take into consideration the patient's weight and the
exposure to fluoride from dietary and other sources to establish the
proper dose (Ref. 4).
Therefore, the agency finds no basis to require an advisory
statement concerning infant fluoride consumption on bottled waters
containing 0.3 ppm or more fluoride.
C. Nomenclature
FDA proposed that the name of the standardized food meeting the
definition of bottled water in Sec. 165.110(a)(1) is ``bottled water''
or one of the following defined terms: ``Artesian water,'' ``distilled
water,'' ``mineral water,'' ``purified water,'' ``spring water,'' and
``well water.'' The agency requested comments from interested persons
on the definitions for these terms and on other terms that need to be
defined.
11. A number of comments requested that FDA define the term
``drinking water'' because: (1) It is the most commonly used term to
describe bottled water and represents 36 to 40 percent of the gallonage
of bottled water sold in food stores; (2) the lack of a Federal
definition allows States to adopt special, nonuniform definitions for
this segment of the bottled water market; and (3) many bottlers would
have to revise their drinking water labels to remove this term to come
into compliance with the standard, and doing so would impose severe
economic hardships to the industry. One comment noted that producers of
5-gallon returnable bottled water products have a very large investment
in bottle inventories that are designed to last for a considerable
time, and that a high percentage of these packages is permanently
labeled as ``drinking water.'' It stated that it would be costly to
dispose of these containers, and that the use of stick-on labels would
present problems in its manufacturing operation.
Some comments recommended modifying paragraph Sec. 165.110(a)(2) to
define the terms ``bottled water'' and ``drinking water'' synonymously.
However, other comments stated that ``drinking water'' is a
classification within the bottled water category along with ``spring
water,'' ``mineral water,'' and ``purified water.'' These comments
suggested the following definition: ``Drinking water means bottled
water obtained from an approved source that has at a minimum undergone
treatment consisting of filtration (activated carbon or particulate)
and ozonation or an equivalent disinfection process. Drinking water
that has been treated to meet the definitions of distilled or purified
water may contain added minerals for taste, provided an ingredient
statement `minerals added for taste' or optionally `minerals added for
flavor' appears on the label.''
One comment stated that it is important for FDA to define drinking
water as only one type of bottled water, and that the terms ``drinking
water'' and ``bottled water'' not be interchangeable. It stated that
``bottled water'' includes and describes all types of bottled water
products, including bottled ``drinking water,'' but that bottled
``drinking water'' does not include or describe all types of ``bottled
water.'' It stated that it is important that FDA define ``drinking
water'' to prevent the consumer confusion that would result if this
product type, already marketed to and accepted by the public, is not
recognized by FDA as a specific type of bottled water. It stated that
failure to do so could, at worst, mean that products labeled as
``drinking water'' could no longer be sold in interstate or foreign
commerce involving the United States.
Conversely, two comments stated that the term ``drinking water''
should not be permitted on the label because consumers may be misled
because they do not understand the meaning of the term.
The agency agrees with the comments that stated that it should
define the term ``drinking water.'' Consumers are familiar with the
term because, as the comments pointed out, products labeled as
``drinking water'' comprise a significant portion of the bottled water
market. In addition, not defining this term would impose an economic
hardship on the bottled water industry because products labeled as
``drinking water'' would have to be relabeled as ``bottled water.''
However, FDA disagrees with the comments that said that ``drinking
water'' should be defined differently than ``bottled water.'' As
required by the standard of quality, ``bottled water'' must meet
certain quality requirements, or the water is substandard and must be
labeled as such. The definition for ``drinking water'' suggested by the
comments provides an apt description of the method of processing
bottled water that is used by many manufacturers. Thus, FDA concludes
that a separate definition of ``drinking water'' is not warranted.
In addition, EPA has standards for ``drinking water'' from public
water systems (40 CFR parts 141 and 143) that are nearly identical to
FDA's standards for bottled water. FDA is not aware of any reason why
its standard for ``drinking water'' that is sold in a bottle should
differ significantly from EPA's standard for ``drinking water.''
Therefore, the agency is including ``drinking water'' as an alternative
name for ``bottled water'' in Sec. 165.110(a)(2).
The agency agrees with the comments that pointed out that if
minerals are added to bottled water or drinking water, an appropriate
statement of identity must appear on the principal display panel of the
label of the product
[[Page 57081]]
to inform consumers of this fact (e.g., ``drinking water with minerals
added for taste''). An ingredient statement must also appear on the
label in accordance with Sec. 101.4(a). In addition, if sodium,
calcium, or iron are present in the bottled water product in more than
an insignificant amount, nutrition labeling is required.
12. One comment suggested that an alternative name for ``spring
water'' or ``well water'' could be ``ground water.''
The agency agrees that ``ground water'' is an appropriate name for
water from a spring or a well. The term ``ground water'' encompasses
not only ``spring water'' and ``well water'' but also ``artesian
water'' and ``mineral water'' because by definition all of these waters
come from an underground source. A geological definition states that
``ground water'' is water in the saturated zone that is under a
pressure equal to or greater than atmospheric pressure (Ref. 5). The
saturated zone is the subsurface zone in which all openings are full of
water (id.).
Because ``ground water'' is an appropriate alternative term to
describe some types of bottled water, and because in the January 1993
proposal, the agency requested comments from interested persons on
other terms that need to be defined, the agency concludes that it is
within the scope of this rulemaking to define the term ``ground
water.'' FDA concludes that the geological definition stated above is
appropriate. Therefore, the agency is defining ``ground water'' in
Sec. 165.110(a)(2)(ii) to mean water from a subsurface saturated zone
that is under a pressure equal to or greater than atmospheric pressure.
(Because the agency is establishing an additional definition in
Sec. 165.110(a)(2), it is recodifying the other terms in
Sec. 165.110(a)(2) so that they continue to appear in alphabetical
order.) The agency is also requiring in Sec. 165.110(a)(2)(ii) that
``ground water'' not be under the direct influence of surface water.
EPA defines ground water under the direct influence of surface water as
any water beneath the surface of the ground with: (1) Significant
occurrence of insects or other macroorganisms, algae, or large-diameter
pathogens such as Giardia lamblia; or (2) significant and relatively
rapid shifts in water characteristics such as turbidity, temperature,
conductivity, or pH which closely correlate to climatological or
surface water conditions (40 CFR 141.2). Ground water under the direct
influence of surface water is not ``ground water'' because water that
does not meet this definition is mingling with water that otherwise
would meet the definition. To clarify that ground water must not be
under the direct influence of surface water, FDA concludes that this
distinction should be included in the definition of ``ground water.''
13. One comment stated that FDA should establish a separate
definition for ``sterilized water.'' It stated that water for the
initial feeding of babies has been called ``sterilized water'' for
decades. The comment held that all water intended for the initial
feeding of infants should be commercially sterile, as defined in the
low-acid canned food processing regulations (21 CFR part 113). The
comment stated that to require a change in the statement of identity
from ``sterilized water'' to ``bottled water'' or ``purified'' or
``distilled water'' would create confusion in hospitals and could
result in nonsterilized ``bottled water'' or ``purified'' or
``distilled water'' being fed to newborns. The comment suggested that
the following definition be added to Sec. 165.110(a)(2)(vi): ``The name
of the water intended as the initial feeding of infants may be
`sterilized water' provided it meets the definition of commercial
sterility contained in 21 CFR 113.3(e)(1)(i).''
The agency agrees that the terms ``sterile water'' and ``sterilized
water'' should be defined as a specific bottled water type. Doing so is
the logical outgrowth of FDA's request in the proposal for other terms
that need to be defined. Defining these terms will mean that the water
must meet a certain minimum standard to be labeled with these terms and
will allow firms to prominently label their products in the statements
of identity as having been treated to achieve this standard.
The definition of commercial sterility in Sec. 113.3(e)(1)(i)
states that ``commercial sterility'' of thermally processed food means
the condition achieved by the application of heat that renders the food
free of microorganisms capable of reproducing in the food under normal
nonrefrigerated conditions of storage and distribution and of viable
microorganisms (including spores) of public health significance.
FDA notes that the United States Pharmacopeia (USP) has official
monographs for ``sterile water for inhalation,'' ``sterile water for
injection,'' and ``sterile water for irrigation.'' The monographs
require that each of these types of water meet sterility requirements
set forth by the USP (Ref. 6). These requirements involve
microbiological tests to determine the presence of viable
microorganisms. If no evidence of microbial growth is observed, the
article tested meets the requirements of the test for sterility.
The difference between the sterility standard in
Sec. 113.3(e)(1)(i) and that used by USP is that water that is
commercially sterile may contain bacteria, although in an innocuous
amount, whereas water that is sterile according to USP standards does
not. The agency acknowledges that water for general drinking purposes
need not be sterile or even commercially sterile. However, sterile
water may be purchased by immunosuppressed individuals, contact lens
wearers, infant caretakers, and laboratories with an expectation that
the water is free of any bacteria. In addition, FDA finds that it would
be confusing to consumers to have two standards for sterility, one for
``sterile water'' and another for ``sterile water, USP.''
Therefore, the agency concludes that bottled water labeled as
``sterile'' must meet the USP definition. Thus, FDA is defining the
terms ``sterile water'' and ``sterilized water'' in
Sec. 165.110(a)(2)(vii) to mean water that meets the requirements under
``Sterility Tests'' <71> in the USP, 23d Revision.
14. Several comments requested that the agency clarify whether a
bottler may use any name defined in Sec. 165.110(a)(2) as long as the
bottled water complies with the definition used. One comment asked
whether mineral water that contains between 250 and 500 ppm TDS could
be labeled as ``mineral water,'' ``mineral spring water,'' or ``mineral
well water.''
The agency advises that if more than one term is applicable,
bottlers may combine the terms, as appropriate, in naming the food
(e.g., ``mineral spring water, low mineral content''). Thus, bottlers
will be able to label their products in an informative manner because
all applicable terms can be presented prominently on the labels in the
statements of identity. Because this approach will ensure the
informativeness of the statement of identity, FDA finds that it will
promote honesty and fair dealing in the interest of consumers.
Therefore, FDA is revising Sec. 165.110(a)(2) to state that the name of
the food is ``bottled water,'' ``drinking water,'' or alternatively one
or more of the terms listed in that section as appropriate.
15. Two comments expressed concern that the proposed definitions
for ``artesian water,'' ``mineral water,'' ``spring water,'' and ``well
water'' provide an opportunity for unintended mineral content
manipulation that could lead to potential consumer deception. To
alleviate this problem, the comments requested that FDA revise the
[[Page 57082]]
definitions for each of these waters to include the following:
``Artesian water (or mineral water, spring water, or well water) shall
not be altered by addition or deletion of minerals or by blending it
with water from a nonartesian water source.''
FDA disagrees that the suggested revision is warranted or needed.
Once a defined bottled water product (e.g., artesian water, mineral
water, spring water, or well water) has been blended with water from
another source, the product no longer meets the definition of that
particular type of bottled water, although it remains bottled water.
For example, if artesian water is blended with spring water to reduce
the water hardness, the product is ``bottled water'' or ``drinking
water,'' although its labeling may state the percentages of the
artesian water and spring water it contains. Mineral water may be
labeled as ``mineral water'' even if it is a blend of one or more
waters, as long as each of the component waters complies with the
source, composition, and other requirements of Sec. 165.110(a)(2)(iii).
The agency notes that mineral addition or deletion does not change
the source of the water. However, if the water has been altered
significantly from the source water, under section 201(n) of the act,
that the alteration has been made is a fact material in the light of
representations made and must appear on the label of the product. The
water is no longer unmodified ground water and differs significantly
from the water that was harvested. Therefore, the fact that the water
has been altered significantly must be included in the statement of
identity so that consumers are aware that the source water has been
modified. If minerals have been added, the statement of identity must
state that fact. If minerals have been removed from the product, other
than those that are removed during normal processing (e.g., filtration
to remove precipitates), that fact must be included in the statement of
identity of the product (e.g., partially demineralized)
(Sec. 165.110(a)(2)(iii)). Therefore, FDA concludes that the requested
revision is not necessary.
1. Artesian Water
The agency proposed to define ``artesian water'' as water from a
well tapping a confined aquifer in which the water level stands above
the natural water table. The agency also proposed to provide for the
collection of artesian water with the assistance of an external force
to enhance the natural underground pressure so long as such measures do
not alter the physical properties, composition, and quality of the
water.
16. One comment stated that FDA should not permit the use of the
term ``artesian'' on bottled water labels because it is the most
misused term in the bottled water business today.
The agency disagrees that it should prohibit the use of the name
``artesian.'' Because FDA is defining this term in the standard of
identity for bottled water, manufacturers will have to label their
products in accordance with the standard or face regulatory action. FDA
expects that misuse of the term will cease as a result. Therefore, FDA
concludes that this comment, rather than establishing why FDA should
not define ``artesian water,'' only serves to point up why defining
this term will promote honesty and fair dealing in the interest of
consumers, and, thus, why it is appropriate for FDA to do so.
17. Several comments stated that the original and vernacular
meaning of ``artesian water'' is water that is forced from below the
ground to the surface through a well by natural underground pressure
and collected at or above the surface. They recommended that this
definition be adopted.
One comment pointed out that the geologic definition that FDA
referenced in the proposal actually states that ``the water level in
artesian wells stands at some height above the top of the aquifer but
not necessarily above the land surface'' and does not require that the
water stand above the water table. Therefore, the comment added, the
water level in an artesian well may be either above or below the water
table and still be considered artesian. The comment stated that the
distinction in the geologic definition between the water table and the
top of the confined aquifer is an important technical one, and that the
proposed definition is much more restrictive and not the one that is
generally accepted by groundwater scientists.
The agency disagrees with the comments that contended that the
water in an artesian well must flow to the surface. As mentioned by the
latter comment described above, the geologic definition states that
``the water in artesian wells stands at some height above the top of
the aquifer but not necessarily above the land surface'' (Ref. 5).
Therefore, the geologic definition does not require that the water flow
to the surface, or that, as FDA proposed (58 FR 393 at 398), the water
level stand above the natural water table. Because the agency intended
that its definition for ``artesian water'' be the geologic definition,
it is revising the definition of artesian water in
Sec. 165.110(a)(2)(i) to state that bottled water that is drawn from a
well tapping a confined aquifer in which the water level stands at some
height above the top of the aquifer may be called ``artesian water'' or
alternatively ``artesian well water.''
Concerning artesian water that flows to the surface, FDA notes that
a typical geologic definition states that ``if the water level in an
artesian well stands above the land surface, the well is a flowing
artesian well'' (Ref. 5). The agency would not object to manufacturers
labeling their products accordingly, as long as it is done in a
truthful and nonmisleading manner. However, the name of the food
remains ``artesian water'' or ``artesian well water.''
18. One comment urged that the specific name ``artesian well
water'' be permitted on labels instead of ``artesian water'' to provide
full disclosure to consumers.
FDA advises that both ``artesian well water'' and ``artesian
water'' can be used to identify this product because both terms
appropriately describe it, and consumers would recognize either term.
``Artesian water'' does indeed come from a well and only differs from
``well water'' in that the water comes from a confined aquifer where
the water is under pressure and stands at some height above the top of
the aquifer. Therefore, FDA is modifying Sec. 165.110(a)(2)(i) to state
that the name of water from a well tapping a confined aquifer in which
the water level stands at some height above the top of the aquifer may
be ``artesian water'' or ``artesian well water.''
19. One comment asked how someone who is reviewing the label
statement ``artesian well water'' will be able to verify that the well
is actually an artesian well, meeting the definition, after the well
has been bored and is in production.
The agency agrees that there must be some means of verifying food
labeling claims. In specific instances FDA may require that records or
other means of verification be provided to FDA regulatory officials,
despite the act's lack of express, general statutory records access
authority for foods. The Supreme Court has recognized that FDA has
authority that ``is implicit in the regulatory scheme, not spelled out
in haec verba'' in the statute. Weinberger v. Bentex Pharmaceuticals,
Inc., 412 U.S. 645, 653 (1973). Indeed, ``it is a fundamental principle
of administrative law that the powers of an administrative agency are
not limited to those expressly granted by the statutes, but include,
also, all of the powers that may fairly be implied therefrom. * * * In
[[Page 57083]]
the construction of a grant of powers, it is a general principle of law
that where the end is required the appropriate means are given and that
every grant of power carries with it the use of necessary and lawful
means for its effective execution.'' (See Morrow v. Clayton, 326 F.2d
35, 44 (10th Cir. 1963).)
Under section 701(a) of the act (21 U.S.C. 371(a)), the agency may
promulgate regulations for the efficient enforcement of the act.
Although it is possible to determine that a source of water is an
artesian well after the well is in operation, in some cases it would be
onerous for regulatory officials to do so. Therefore, FDA has
determined that a verification requirement is necessary for the
efficient enforcement of the act. FDA has previously stated that a food
manufacturer is responsible for the accuracy of its food labels (58 FR
2079, 2163, and 2165, January 6, 1993). Indeed, placing a claim in food
labeling that calls the consumer's attention to a water's source is a
representation that the manufacturer has evidence that the product
meets the requirements for the claim. See Thompson Medical Co., Inc. v.
FTC, 791 F.d. 189, 193 (D.C. Cir. 1986), cert. denied, 479 U.S. 1086
(1987). Making a claim without such a basis would be misleading, in
violation of section 403(a) of the act.
The agency anticipates that, in some instances, companies will be
amenable to demonstrating to FDA the basis for the claim, regardless of
the existence of these regulations. The agency considers, however,
that, when a product bears a claim based on information available
solely to the manufacturer, it is reasonable for the agency to have
access to that information. See United States v. An Article of Device,
731 F.d. 1253, 1261-62 (7th Cir. 1984) (upholding regulation requiring
makers of prescription devices to be able to prove that their devices
work safely for their intended purposes and stating that ``[w]here the
government's access to the necessary information may be limited * * *
it seems not inappropriate to put the burden of persuasion on the party
who * * * presumably has better access to the relevant information'');
see also Trans-American Van Service, Inc. v. United States, 421 F.
Supp. 308, 331 (N.D. Tex. 1976). Therefore, FDA is modifying
Sec. 165.110(a)(2)(i) to require that plants be able to demonstrate to
regulatory officials that the water level of the well stands at some
height above the top of the aquifer, and, thus, that the well is an
artesian well. Compliance with this provision does not entail the
creation of any new information or the compilation of any special
records. Rather, the requirement would obligate manufacturers simply to
have access to information that they should already possess, or to make
a measurement of their well, and to provide FDA with this information.
FDA considers this requirement to be the logical outgrowth of its
January 1993 proposal. The purpose of this rulemaking is to ensure that
terms such as ``artesian water'' are used in a manner that promotes
honesty and fair dealing (see section 401 of the act (21 U.S.C. 341)).
Such a result requires not only that these terms be appropriately
defined, but that they be used in a manner that accurately describes
the product. Thus, how FDA would enforce the definitions was a matter
that was within the purview of the proposal, and that the agency would
provide for such enforcement in the final rule in this proceeding was
reasonably foreshadowed by the proposal. The fact that FDA received
comments on how it would ensure that the defined terms are
appropriately used evidences that this issue is the logical outgrowth
of the proposal.
To comply with this requirement, producers may maintain records
that demonstrate that the well is indeed an artesian well. The
manufacturer may also rely on records from the company that drilled the
well. In addition, many States and the United States Geological Survey
have records of some wells and of the geology of the surrounding area.
To verify that the water is at some height above the top of the aquifer
and is, thus, artesian water, the pump may be shut off, and the height
or the pressure of the water in the drilled hole measured. This
information can then be used, along with information on the depth of
the aquifer, to determine whether the water is artesian water. If the
source does not meet the definition of artesian water, the product must
not be labeled as artesian water, or it is misbranded under sections
403(a), 403(b), and 403(g) of the act.
20. One comment stated that water chemistry changes as wells are
pumped, and that the larger the drawdown, the greater the water
chemistry may change. It stated that a mineralogical analysis from a
water sample taken at 10 gallons per minute (gpm) may be quite
different than one taken at 500 gpm for the same well. The comment
added that there would be an ongoing burden on FDA to verify that water
produced by bottlers drawing on ``artesian'' groundwater resources
remains constant in water chemistry.
FDA agrees with the comment. The use of external force may alter
the physical properties, composition, and quality of the water,
although usually not significantly, depending on the rate of
extraction, because of changes in the pressure of the water as it is
extracted. This fact is the basis on which the agency proposed to
require that the use of external force not alter these characteristics
(58 FR 393 at 398). However, because the rate of extraction from the
use of external force could vary from day to day or even hour to hour,
the characteristics of the water can be also altered.
As discussed in the previous comment, the agency is requiring that
the manufacturer demonstrate that the source of the water is indeed an
artesian source. However, the agency does not deem it necessary to
require that the definition for artesian water extend to the physical
properties, composition, and quality of the water. In fact, as long as
the source is demonstrated to be an artesian source that meets the
definition in Sec. 165.110(a)(2)(i), the actual characteristics of the
water are a quality control concern for the manufacturer rather than an
attribute that defines artesian water. As stated previously, the agency
intends that its definition of artesian water be the geological
definition. The geological definition does not take into consideration
the composition of the water. Therefore, the agency is removing the
requirement in Sec. 165.110(a)(2)(i) that the use of external force in
the extraction of artesian water not alter the physical properties,
composition, and quality of the water.
2. Mineral Water
The agency proposed that water coming from a source tapped at one
or more bore holes or springs, originating from a geologically and
physically protected underground water source, may be called ``mineral
water.'' FDA further proposed that mineral water be distinguished from
other types of water by its constant level of minerals and trace
elements at the point it emerges from the source.
The agency tentatively concluded in the proposal that it would be
contradictory for bottled water that has essentially no minerals and
does not perform (e.g., taste) like mineral water to be labeled as
mineral water. Consistent with this tentative conclusion, FDA proposed
that ``mineral water'' be defined as water containing not less than 250
ppm TDS. The agency requested comments on the proposed minimum level of
250 ppm TDS in mineral water and stated that if it received substantive
data to support another minimum level, it would consider issuing a
final rule with a different minimum level.
[[Page 57084]]
21. A number of comments objected to FDA establishing a minimum TDS
level for mineral water. The comments argued that establishing such a
level would be arbitrary and contrary to the most current mineral water
definitions, including international definitions which do not include a
minimum level, and would prohibit many brands from being labeled as
mineral water, thereby adversely affecting consumer sales with no
apparent benefit to consumers.
Conversely, other comments suggested raising the minimum TDS level
to 500 ppm. These comments argued that establishing the minimum TDS at
the higher level would: (1) Make it closer to the definition that has
been adopted by most States that have bottled water regulations and to
the definition that is currently being considered by the Canadian
Government; (2) provide the basis for identification of the term
``mineral water'' with the distinctive taste of a higher mineral
content; (3) be less confusing to consumers in that it would not allow
the same water to be marketed under several names (e.g., ``mineral
water, low mineral content'' or ``spring water''); and (4) simplify
application of the quality standards and the label identity statement.
Several comments expressed the view that mineral water is ground
water with at least 50 ppm TDS, while several other comments supported
the proposed minimum level of 250 ppm TDS in mineral water. One of
these comments stated that waters having a TDS of 250 ppm or more
generally have a distinctive flavor. Two comments, however, stated that
actual taste thresholds for mineral water are often in the range of 100
ppm TDS. One of these comments stated that consumer identification and
differentiation among the flavors of various individual source waters,
which result from naturally occurring mineral variations in the water,
is clearly possible below the proposed threshold of 250 ppm TDS.
The agency acknowledges that many different definitions exist for
``mineral water.'' In the January 1993 proposal, the agency compared
several current definitions, including State and European standards, in
arriving at its proposed definition (58 FR 393 at 396). International
standards vary from requiring at least 500 ppm TDS (Canadian Province
of Quebec) to no minimum requirement (ERCS). In a like manner,
different States have different requirements. Therefore, no FDA action
will harmonize existing State and international regulations.
As stated in the proposal (58 FR 393 at 397), the minimum level of
250 ppm TDS for mineral water is based on the apparent consumer
expectation that a product identified as ``mineral water'' will contain
at least a minimum level of minerals. The agency tentatively concluded
that it would be misleading for bottled water that has essentially no
minerals, and that does not perform (e.g., taste) like mineral water,
to be labeled as mineral water. The minimum level that FDA proposed,
250 ppm TDS, is in agreement with the Association of Food and Drug
Officials (AFDO) definition (Ref. 7) for light mineral water and
mineral water.
The main characteristic of mineral water is, as its name implies,
the presence of a significant quantity of minerals. Other important
characteristics (Ref. 8) are that it be from a geologically and
physically protected underground water source, and that it contain a
constant level of minerals and trace elements at its point of emergence
from the source. Mineral water may come from a spring or a well,
including an artesian well, but must contain a significant amount of
minerals. The agency considers 250 ppm TDS as a significant amount of
minerals because at this level, the minerals, depending on the specific
mineral content, begin to impart a particular taste to the water.
Although minerals may impart some taste below this level, it is not the
significant mineral taste that is characteristic of mineral water.
FDA recognizes that mineral water from a spring that contains
between 250 and 500 ppm TDS may be identified as ``spring water,''
``mineral water, low mineral content,'' or both. However, FDA disagrees
that the availability of these terms will cause consumer confusion
because such a product meets the definitions of both ``mineral water''
and ``spring water'' in Sec. 165.110(a)(2)(iii) and (a)(2)(vi), and
both terms appropriately describe the product. As discussed previously
(see comment 14 of this document), use of all applicable terms
presented prominently on the label in the statement of identity is
appropriate because it will ensure the informativeness of the statement
of identity.
FDA realizes that brands previously sold as ``mineral water'' that
contain less than 250 ppm TDS will not be provided for under
Sec. 165.110 as ``mineral water.'' However, the brands mentioned in the
comments are not being sold in the United States as mineral water but
as other types of bottled water (e.g., spring water) because of the
many State requirements that mineral water contain greater than 500 ppm
TDS. Thus, although some of these brands cannot be labeled as ``mineral
water,'' other brands that previously could not be labeled as ``mineral
water'' and sold in some States now meet the definition of ``mineral
water'' in Sec. 165.110(a)(2)(iii) and can be labeled and sold as such.
Moreover, the agency has not been persuaded that this regulation
will adversely influence consumer sales or put some bottled mineral
water producers at a disadvantage as compared to others. The comments
did not provide any information on such adverse consequences, and the
agency is not aware of these adverse effects.
Therefore, for the reasons discussed above, FDA concludes that
establishing a minimum level of TDS in mineral water is reasonable, and
that the proposed level of 250 ppm TDS is the appropriate level.
22. One comment remarked that some bottled waters would not
significantly differ from a mineral water slightly above the 250 ppm
TDS minimum. Another comment stated that if companies wish to market
their products on the basis of the mineral content, they can do so
through a TDS disclosure statement on the principal display panel
regardless of the amount present. Therefore, there would be no need to
establish a minimum TDS level for mineral water.
Several comments declared that each mineral water product is unique
because of its particular composition of minerals, and that this unique
character imparts distinctive flavor. These comments stated that some
water products with a constant mineral content of less than 250 ppm TDS
might have a distinctive flavor and should be called ``mineral water--
very low mineral content'' or ``mineral light.''
Comments also stated that establishing a level of 250 ppm TDS is
contrary to the industry's belief that the overall mineral content is
less important than the level of each particular mineral.
The agency agrees that some waters that contain slightly less than
the 250 ppm TDS minimum would not significantly differ from a mineral
water slightly above the minimum. Any minimum level that the agency
establishes will preclude some waters from bearing the term ``mineral
water'' even though they do not vary significantly from waters that are
above the minimum. FDA also agrees that there is a taste aspect to the
presence of minerals, although some minerals may contribute a more
distinct flavor to the water than others. For example, in sufficient
amounts, sodium chloride gives water a salty taste, and sulfate
contributes a bitter taste (Ref. 5). In fact,
[[Page 57085]]
a common industry practice is to add minerals to some bottled waters
for the flavor that they contribute.
However, a minimum requirement for TDS is necessary to ensure that
when consumers purchase a product labeled as ``mineral water,'' the
product contains minerals at a level that justifies calling the product
by that name. As explained in response to the previous comment, that
level is 250 ppm TDS. The minimum TDS requirement for mineral water
will not preclude a product that contains less than 250 ppm TDS from
being marketed under another name, such as ``ground water,'' ``spring
water,'' or ``well water,'' as applicable, or from being called
``bottled water.'' In addition, manufacturers may include a truthful
statement of the TDS level on the label of any bottled water product.
Thus, even though FDA has carefully considered these comments, it
concludes that it is appropriate to establish a minimum TDS requirement
for ``mineral water.''
23. One comment stated that the definition for ``mineral water''
should include all water containing over 500 ppm TDS and argued that
whether it occurs naturally or is constructed (as are other food
products) is irrelevant. The comment added that if mineral solids are
added, FDA should require that such additions be noted on the label.
Another comment stated that it is essential that the definition be
clear that mineral water may not be altered by the addition or deletion
of minerals. The comment stated that mineral water should not be water
that is derived from a public water supply and to which minerals are
then added.
FDA disagrees with the comment that advocated that water to which
minerals have been added should be eligible to be called ``mineral
water.'' The agency has reviewed a number of State and foreign
standards, and none define ``mineral water'' as containing added
minerals (Ref. 8). In fact, many of these standards define water with
added minerals as a different type of bottled water, distinct from
``mineral water.'' Therefore, the agency concludes that the definition
for ``mineral water'' should not be revised to permit the addition of
minerals.
The agency agrees with the comment that stated that the addition of
minerals should be clearly prohibited in the definition for mineral
water. The definition for mineral water has geological as well as
compositional factors. The amounts and types of minerals in mineral
water is a result of the path that the water has traveled underground.
Therefore, to clarify that the minerals present in mineral water must
be from the underground source and not added to the water after
extraction, FDA is modifying the definition of mineral water in
Sec. 165.110(a)(2)(iii) to specifically preclude the addition of
minerals.
However, some mineral waters as extracted from their geological
source, may contain high levels of some undesirable minerals (e.g.,
arsenic, precipitated manganese). In some instances, the water can be
treated to selectively remove these undesirable elements. FDA is aware
of no reason why it should preclude the removal of these undesirable
elements, or why such removal should preclude the manufacturer from
labeling the product as ``mineral water'' as long as all other
requirements (e.g., source and composition) of the definition are met.
Section 165.110(a)(2)(iii) provides accordingly.
24. Several comments requested that FDA more precisely define
``mineral water'' in that the agency should require that the level and
relative proportions of minerals and trace elements remain constant.
Comments stated that such a requirement would harmonize the definition
of mineral water with the European Community and Codex concepts. These
comments suggested the following definition: ``Mineral water shall be
distinguished from other types of water by its constant level and
relative proportions of minerals and trace elements, at the point of
emergence from the source, due account being taken of the cycles of
natural fluctuations.'' One comment added that this wording recognizes
that minor natural fluctuations occur with any source water.
Some comments requested that the agency clarify that, in the term
``constant level of minerals,'' the ``level'' is not the characteristic
element. They stated that what is fundamental is the ``constancy'' or
``stability'' of the mineral composition, which acts more as a
fingerprint of the water rather than as a measure of the overall total
dissolved solids content.
One comment stated that all ground water (well or spring) has a
constant level of minerals and trace elements as it emerges from the
source. The comment questioned the scientific basis of FDA's approach.
The agency agrees that it needs to clarify its definition of
mineral water. In the proposal (58 FR 393 at 396), FDA stated that
mineral waters may have very different flavors depending on the mineral
content and types of minerals and trace elements present in the water.
Consumers may purchase a particular mineral water from a particular
source because of the flavor contributed by the mineral content. It is
important to consumers that the mineral composition of a particular
source remain constant. FDA considers that industry and consumers have
come to expect that mineral water has a fairly stable mineral
composition. Therefore, FDA proposed that mineral water be
distinguished from other types of water by the constant level of
minerals and trace elements in the water as it emerges from its source.
FDA further notes that the ERCS defines ``natural mineral water''
as being characterized by its content of certain mineral salts and
their relative proportions and by the presence of trace elements or
other constituents (Ref. 1). The ERCS also states that mineral water is
characterized by the constancy of its composition, the stability of its
discharge, and its temperature, due account being taken of the cycles
of natural fluctuations.
As stated previously, the composition and concentration of
substances dissolved in ground water depend on the chemical composition
of precipitation, on the biologic and chemical reactions occurring on
the land surface and in the soil zone, and on the mineral composition
of the aquifers and confining beds through which the water moves (Ref.
5). Thus, under constant conditions, the mineral content of ground
water will be constant. There are certain natural factors that may
affect the constancy of a source such as occurrence of earthquakes and
long term climatic changes. These natural factors do not preclude the
water from qualifying as mineral water as long as the water continues
to meet the compositional requirements in Sec. 165.110(a)(2)(iii).
Therefore, to clarify the importance of the relative proportion of
minerals and trace elements, and to take into account the cycles of
natural fluctuations, FDA concludes that modification of the definition
of mineral water, along the lines requested by the comments, is
appropriate. The modification reflects the fact that there may be some
minor variation in mineral water over time, and that absolute amounts
of minerals in the water may change slightly. Thus, the agency is
modifying Sec. 165.110(a)(2)(iii) to state that mineral water shall be
distinguished from other types of water not only by its constant level
of minerals and trace elements at the point of emergence from the
source, but also by its relative proportions of these substances, due
account being taken of the cycles of natural fluctuations. Natural
fluctuations in mineral content may occur, but these fluctuations must
not affect the relative
[[Page 57086]]
proportions of minerals and trace elements. Samples of mineral water
can be compared to ensure that major dissolved mineral contents are the
same using several scientific methods, such as the Stiff diagram and
the Piper trilinear diagram (Ref. 9).
25. Two comments urged FDA to amend the proposed definition for
``mineral water'' to require that if mineral water is taken from a bore
hole tapping a spring, it be from the same underground stratum, and be
of the same quality and composition, as the water derived from the
natural orifice.
The comments seem to be arguing that any product drawn from a
spring must meet the requirements for ``spring water.'' However, this
is not the case. A product need only meet the requirements for the term
used to name it. Thus, a product labeled as ``mineral water'' need only
meet the requirements in Sec. 165.110(a)(2)(iii). It need not meet the
definition for ``spring water'' unless its label claims that the water
is also spring water. If the product were, however, to claim to be
``mineral spring water,'' it must meet the definition of spring water
in Sec. 165.110(a)(2)(v) as well as that for ``mineral water.''
26. One comment noted that the proposed definition of mineral water
refers to water ``* * * originating from a geologically and physically
protected underground water source.'' The comment stated that this
phrase appears to be ambiguous and meaningless because there is no
indication in the definition of what would constitute protection. It
stated that the terminology seems to offer the consumer some assurance
of purity that may not be warranted. The comment asserted that every
ground water source inherently possesses some degree of geologic and
physical protection by the very fact that it is underground. It stated
that there are no operational means to differentiate a protected
underground water source from an unprotected one.
The agency agrees that every ground water source inherently
possesses some degree of geologic and physical protection by the very
fact that it is underground. However, some underground water sources
are not protected. This lack of protection is evidenced by the fact
that some underground sources are under the direct influence of surface
water. As discussed earlier (see comment 12 of this document), EPA
defines ground water under the direct influence of surface water as any
water beneath the surface of the ground with: (1) Significant
occurrence of insects or other macroorganisms, algae, or large-diameter
pathogens such as Giardia lamblia; or (2) significant and relatively
rapid shifts in water characteristics such as turbidity, temperature,
conductivity, or pH that closely correlate to climatological or surface
water conditions (40 CFR 141.2).
The latter part of EPA's definition pertains to changes in the
physical characteristics of the water. Changes in these physical
characteristics can have a significant influence on the mineral
composition of the water. Because the definition of ``mineral water''
is geological as well as compositional, the agency concludes that it is
important that ``mineral water'' be from a physically protected
underground water source. Mineral water has been traditionally
distinguished from other types of water by its constant level, and
relative proportions, of minerals and trace elements at the point of
emergence from the source, due account being taken of the cycles of
natural fluctuations. This distinction is a reflection of the fact
that, traditionally, the mineral composition of products labeled as
mineral water does not vary significantly over time. Therefore, it is
important that mineral water come from a geologically protected
underground source, so that the mineral water retains its distinctive
mineral content.
FDA does not agree, however, that there are no operational means to
differentiate a protected underground water source from an unprotected
one. The presence of insects or other macroorganisms as well as changes
in physical characteristics are measurable. Thus, regulatory officials
can determine whether mineral water is from a geologically and
physically protected underground source.
27. One comment stated that the label statement ``mineral water''
will lead some consumers to believe that the food contains a
nutritionally significant amount of minerals. It stated that this
perception will occur even if the food is labeled ``low mineral
content,'' because ``low'' is a relative term and not a quantitative
term. Therefore, the comment asserted that all bottled water labeled as
``mineral water'' should also bear nutrition labeling or a statement
such as, ``Not a significant source of ________________,'' with the
blank being filled in with the names of any essential minerals that are
missing or present in insignificant amounts.
One comment asked whether the statement of identity for ``mineral
water'' or ``mineralized water'' would constitute a health claim and,
thus, trigger full nutrition disclosure, even in abbreviated form.
Another comment stated that use of the term ``mineral water'' should
not require additional nutrition information.
The agency stated in the preamble to the January 1993 proposal (58
FR 393 at 404), that its tentative view was that nutrition labeling
should appear on bottled water labeled as ``mineral water, high mineral
content'' because consumers may assume that water with a high mineral
content would be of nutritional benefit. In addition, mineral water
with a high mineral content could contain enough sodium, calcium, or
iron to make nutrition labeling mandatory. Under Sec. 101.9, foods that
contain more than an insignificant amount of the nutrients or food
components that are required to be listed, or whose label, labeling, or
advertising contains a nutrient content claim or any other nutrition
information, must bear nutrition labeling.
Nutrients likely to be present in bottled water products in amounts
that could trigger nutrition labeling are calcium, sodium, and iron. If
any of these minerals are present in a product in more than
insignificant amounts, nutrition labeling is required under section
403(q) of the act. More than an insignificant amount of calcium is 20
mg or more per labeled serving, more than an insignificant amount of
sodium is 5 mg or more per labeled serving, and more than an
insignificant amount of iron is 0.36 mg or more per labeled serving
(Sec. 101.9(c)(8)). The reference amount customarily consumed for
bottled water is 240 milliliter (mL) (Sec. 101.12(b)).
The agency has considered whether the term ``mineral water'' is an
implied nutrient content claim, and whether, as a result, nutrition
labeling should be mandatory on any product labeled as ``mineral
water'' regardless of the level of required nutrients. In the Federal
Register of January 6, 1993 (58 FR 2302 at 2369), the agency concluded
that when an ingredient constitutes essentially 100 percent of the
food, so that the name of the ingredient is the statement of identity,
the name of the ingredient does not constitute an implied nutrient
content claim, even though in other contexts, reference to the
ingredient could constitute such a claim (see Sec. 101.65(b)(4)). For
example, when the name of the ingredient constitutes the common or
usual name of the product, as described in Sec. 102.5 (21 CFR 102.5),
or the identity of the commodity, as described in Sec. 101.3 (e.g.,
``canola oil''), it is not a nutrient content claim. In such a context,
the name of the ingredient does not imply that a nutrient is present in
a certain amount, but rather, it describes the nature of the
[[Page 57087]]
product. However, the claim ``made only with canola oil'' does
characterize the level of a nutrient in the food. This claim represents
an implied claim that the food is low in saturated fat
(Sec. 101.65(c)).
The term ``mineral water,'' when used as the statement of identity
of the food, does not trigger nutrition labeling because it does not
make a representation, either explicit or implied, about the level of
nutrients in the food. ``Mineral water'' is simply the name of the
food. Although the term ``mineral water'' indicates that the water
contains a significant amount of minerals, it does not imply that these
minerals are nutrients. In fact, not all of the total dissolved solids
in mineral water are nutrients (e.g., bicarbonates). However, labeling
claims that imply the presence or absence of any nutrient in bottled
water would trigger nutrition labeling.
The major dissolved inorganic constituents of ground water are
sodium, magnesium, calcium, chloride, bicarbonate, and sulfate. The
total concentration of these major ions comprises more than 90 percent
of the TDS in the water (Ref. 9). The presence of 83 ppm calcium or 21
ppm sodium or more will trigger nutrition labeling. Therefore, because
mineral water must contain at least 250 ppm TDS, it is likely that many
mineral waters, especially high-mineral-content mineral waters, will
contain enough calcium or sodium that the labels of these products must
bear nutrition labeling.
The agency does not agree with the comment that asserted that
consumers will be led to believe that the food is a significant source
of minerals if the food is labeled ``low mineral content.'' Use of the
term ``low'' does not suggest that minerals are present in a
significant amount. The term ``low,'' as used in the statement of
identity of the product, is not used in a dietary context. It is simply
a qualitative term used as part of the name of the food to describe the
food. Thus, use of the term ``low mineral content'' would not indicate
that the mineral water was a significant source of minerals.
Therefore, for the reasons discussed above, FDA concludes that
consumers will not be misled that mineral water contains more than a
nutritionally insignificant amount of minerals, and nutrition labeling
of all mineral water is not required.
28. Several comments stated that the product should be labeled as
``inorganic mineral water'' because all minerals found in water are in
an inorganic state. They stated that the inorganic minerals found in
water are only substances that have been dissolved by the water itself.
The comments stated that fruits or vegetables take in inorganic
material through their roots to become organic and readily accepted by
the body's cells. They stated that not labeling the product as
``inorganic mineral water'' is misleading to consumers. Additionally
the comments noted that many of the so-called ``minerals'' found in
mineral water are not minerals at all but are in fact inorganic
chemicals. They urged FDA to require the label to read: ``Inorganic
mineral & inorganic chemical content ________________ ppm TDS.''
FDA disagrees with the comment. Minerals by definition are
inorganic elements or chemicals in any food (Ref. 10). Thus, the term
``inorganic'' is not a material fact that must be disclosed in labeling
mineral water because the term ``mineral'' means that the water
contains inorganic chemicals. While the agency recognizes that some
minerals that are also nutrients may be more bioavailable in some foods
than in mineral water (e.g., calcium in milk), the comments did not
provide any data to substantiate their claim that inorganic nutrients
taken into plants systemically are more bioavailable than the same
nutrients in water.
In regards to a required label statement concerning TDS, as will be
discussed later in this final rule, FDA does not require that the TDS
appear on the label of any bottled water product, and the comments have
not provided substantive grounds to do so. However, firms may include
this information on the label of bottled water in a truthful and
nonmisleading manner, including in the manner suggested by the comment
if the firm so chooses.
3. Purified Water
The agency proposed that water that is produced by distillation,
deionization, reverse osmosis, or other suitable processes, and that
meets the definition of ``purified water'' in the most recent edition
of the USP, can be labeled as ``purified water.'' FDA also proposed
that if the water is produced by distillation and meets the USP
standard, alternatively it may be called ``distilled water.''
29. Two comments stated that the term ``purified water'' should not
be permitted on labels because consumers do not understand its specific
meaning and, thus, may be confused by the use of this term. They
requested that only the following specific names be permitted on labels
in order to give full disclosure to the consumer: ``Distilled water,''
``reverse osmosis water,'' and ``deionized water.''
FDA disagrees with these comments. The agency proposed that the
name ``purified water'' be defined as water that has been processed to
meet the requirements of the USP definition for ``purified water.'' An
alternative name for water processed by distillation and that meets the
USP standard is ``distilled water.'' ``Purified water'' and ``distilled
water'' meeting the USP definition have been marketed under these names
for many years, and the comments did not provide any evidence that
consumers do not understand the meaning of these terms. Therefore, the
agency is aware of no basis on which to conclude that these terms will
confuse consumers. The agency views this rulemaking as standardizing
the use of these terms, not introducing new terms into the market.
Manufacturers may include more specific information concerning the
method of preparation of these bottled water products on the label.
Therefore, the comments have not persuaded the agency to alter its
approach to the use of these terms.
However, the agency agrees that the terms ``reverse osmosis water''
and ``deionized water'' are appropriate alternative names for purified
water because these terms describe how water is processed to produce
purified or distilled water. Therefore, FDA is modifying
Sec. 165.110(a)(2)(iv) to provide for the alternative term ``deionized
water'' if the water has been processed by deionization, and ``reverse
osmosis water'' if the water has been processed by reverse osmosis.
30. Several comments objected to FDA's proposal that ``purified
water'' meet the USP definition because: (1) Water for human
consumption does not need to be pharmaceutical grade water; (2) USP
methods of analyses for bottled water are different from EPA and FDA
methods; and (3) the regulation would automatically adopt future
updates of the USP, thus, providing the publisher of the USP with
lawmaking power without any formal comment or review mechanism.
Comments asked that FDA delete any reference to the USP in
Sec. 165.110(a)(2)(iv). Some of the comments recommended that FDA
establish specific standards for purified water rather than adopt the
USP standard by reference.
One comment stated that a standard for purified drinking water
should require the use of ``distillation, deionization, reverse
osmosis, or other suitable processes'' and impose a water conductivity
testing requirement with a conductivity maximum allowable threshold
level of 30 microsiemen per centimeter. It stated that the conductivity
test, which would measure
[[Page 57088]]
the ionic strength of water based on a customarily used reverse osmosis
system, would verify the purification process. Another comment stated
that ``purified water'' should only be required to meet the current USP
requirements for total solids, pH, and chloride.
FDA is persuaded by the comments that the definition of purified
water should not be bound ``to the most recent'' USP standard as it
proposed to do. However, the agency does conclude that the definition
should use the USP standard because purified water meeting this
standard has been sold for years and is an established product.
Although water for human consumption does not need to be pharmaceutical
grade, water that is labeled as ``purified water'' should meet stricter
standards than other types of bottled water because the term
``purified'' asserts that the product has been processed to be of a
purer quality than other types of water. Therefore, requiring that
``purified water'' meet a USP definition ensures that the water meets a
stricter standard than other types of bottled water.
FDA recognizes that it would be a burden for manufacturers
producing purified water and other types of bottled water to have to
use different methods of analysis (USP and EPA) to test for the same
contaminant. Bottlers may use EPA methods to test their purified water,
although the agency notes that it will use USP methods to check for
compliance. However, FDA points out that most of the USP methods do not
provide a numerical water quality requirement that would parallel EPA
methods but instead require testing with a positive or negative result.
Thus, the methods may not be easily interchangeable.
FDA concludes that the requirement should remain as proposed
because the term ``purified water'' explicitly asserts that the water
has been purified, and the USP definition is a commonly used standard
for what constitutes purification. This common use is evidenced by the
fact that AFDO's definition of ``purified water'' is the USP definition
(Ref. 7). However, FDA agrees that interested persons should have an
opportunity to comment on any proposed change in the standard of
identity for purified water. Therefore, FDA is referencing a specific
edition of the USP monograph in the definition of ``purified water''
(Sec. 165.110(a)(2)(iv)). The agency is defining ``purified water'' as
water that has been produced by distillation, deionization, reverse
osmosis, or other suitable processes and that meets the definition of
purified water in the USP, 23d Revision.
The agency notes that the USP is in the process of updating its
monograph for purified water. One such revision may be a water
conductivity test requirement as mentioned by one of the comments. As
modifications are made to the USP definition, FDA will consider
amending its definition for purified water to reflect the modification.
The agency notes that any bottled water that is labeled as
``purified water, USP,'' or that indicates in any manner that the
product meets USP specifications, must, in addition to complying with
FDA regulations, meet the most recent USP standard, or the product will
be misbranded under section 403(a)(1) of the act in that its labeling
will be false in this particular.
31. One comment asked that FDA explicitly designate the product as
``purified drinking water'' and, as a food product, differentiate it
from ``purified water, USP'' usable for pharmaceutical purposes. The
comment stated that a change in nomenclature from ``purified water'' to
``purified drinking water'' would reduce any potential for confusion
between purified water that is suitable for use in preparation of
compendial dosage forms and purified drinking water for potable
purposes. It stated that the qualification would make clear to the
public that products labeled as ``purified drinking water'' are not
represented as, and do not purport to be, in compliance with the USP
monograph for ``purified water.''
The agency disagrees that the term ``purified water'' should be
replaced by ``purified drinking water'' in the standard of identity.
Many products that are currently being sold as ``purified water'' for
drinking purposes meet the USP definition for ``purified water,'' and
FDA is not aware of any evidence of public confusion. Thus, FDA
concludes that ``purified water'' remains an appropriate name.
However, ``purified drinking water'' and ``distilled drinking
water'' are appropriate alternative names for the product because these
names will enable consumers to identify the product as water for
drinking purposes that has been processed to meet stricter purity
standards. Therefore, FDA is modifying Sec. 165.110(a)(2)(iv) to
provide for alternative terms that describe the product as a type of
drinking water (e.g., ``purified drinking water'').
32. One comment recommended that FDA establish a definition for
``demineralized water'' as follows: ``The name of water demineralized
by distillation, reverse osmosis, or other method so that it contains
not more than 10 ppm TDS may be `demineralized water.' ''
The agency agrees that ``demineralized water'' is an appropriate
name for water that has been processed to significantly decrease its
mineral content. However, FDA concludes that there is no need to
establish a separate definition for ``demineralized water'' because the
USP definition for ``purified water'' encompasses water that has been
demineralized by distillation, reverse osmosis, or other method and
that contains not more than 10 ppm TDS. Therefore, the agency is
including the term ``demineralized water'' as an alternative name for
``purified water'' in Sec. 165.110(a)(2)(iv).
33. One comment recommended the establishment of a heterotrophic
bacteria standard for purified water. It stated that, although the
health risks from such bacteria may be small, a higher expectation
exists for a product labeled as ``purified'' than for other bottled
water products. The comment stated that purified water is purchased by
immunosuppressed individuals, contact lens wearers, mothers of small
infants, laboratories, and others with an expectation of purity from
general bacteria. The comment recommended a limit of no more than 500
bacteria per milliliter for purified water because this standard will
limit the suppression of coliform detection and reduce the exposure and
dosage level for organisms that might have a health effect on at- risk
groups. The comment also recommended that, if FDA does not establish a
general bacteria standard for ``purified water,'' the agency substitute
the name ``demineralized water'' for ``purified water'' so as not to
mislead consumers.
FDA disagrees with the comment. Traditionally, water that is
essentially free of chemical impurities is called ``purified water,''
and water that is free of microorganisms is called ``sterile'' or
``sterilized water.'' This distinction is evidenced by the fact that
there are USP monographs for ``sterile water'' and for ``purified
water'' that distinguish between the two types of water (Ref. 6). Thus,
the labeling of a product as ``purified water'' does not imply that it
is sterile water.
USP has established a general guideline for purified water for
pharmaceutical purposes of 100 colony-forming units per mL. This level
evidences that the water has been treated appropriately, even though
bacteria are present at low levels. Purified water that has been
treated by distillation or reverse osmosis may be sterile if
appropriately processed. However, the agency points out that
[[Page 57089]]
purified water is typically low in the nutrients required by
microorganisms for growth, and, thus, ordinarily has low bacterial
counts. Adherence to the regulations in part 129 significantly reduces
the risk of contamination. Therefore, ``purified water,'' if
appropriately processed as required by part 129, should contain less
than the comment's requested 500 bacteria per mL. The agency
consequently concludes that the establishment of a bacterial standard
for ``purified water'' is not necessary.
The agency is defining ``sterile water'' in this final rule. Use of
this term in the statement of identity of qualifying bottled waters
will allow consumers desiring to purchase water that is
bacteriologically pure to easily identify this type of water and to
distinguish it from purified water that is chemically pure.
4. Spring Water
FDA proposed that bottled water derived from an underground
formation from which water flows naturally to the surface of the earth,
or would flow naturally to the surface of the earth if not for its
collection below the earth's surface, may be called ``spring water.''
The agency proposed to provide for the collection of spring water only
at the spring or through a bore hole adjacent to the point of
emergence. FDA also proposed that spring water collected with the
assistance of a bore hole to protect the water shall be from the same
underground stratum as the spring and shall retain all the physical
properties and be of the same composition and quality as the water that
flows naturally to the surface of the earth or that would flow
naturally to the surface of the earth if not for its collection below
the earth's surface. FDA requested comments from interested persons
concerning the definition for ``spring water'' and on the use of a bore
hole adjacent to the point of emergence of the spring to facilitate
collection of the water.
a. Consumer Surveys
34. Two comments included consumer telephone surveys, each
conducted by a different bottled water producer, that addressed issues
of consumer understanding and preferences for bottled water labeled as
``spring water.'' A number of subsequent comments pointed to
methodological shortcomings in one or the other of the two consumer
surveys, including inadequate sample size, nonrepresentative sampling,
ambiguous and biased question wording, failure to counterbalance order
of questions, improper survey approach, and flawed interpretations of
results.
The agency recognizes that such problems exist to some extent in
both studies, as they do in virtually all survey studies, but it is not
convinced that there is sufficient basis for dismissing the results of
these studies. Each study has some merit, and there is a surprising
degree of agreement between the two studies in their primary findings.
Therefore, FDA finds that both studies provide useful information
concerning consumer opinions on spring water, and that it is
appropriate to use this information in arriving at a definition for
``spring water.''
35. The principal concern of both surveys, and the primary subject
of comments about the respective survey results, was an attempt to
describe consumer understanding of the use of the term ``spring water''
with respect to the method of extraction, bore hole or surface
collection, used to obtain the water. In study 1 (C302 in this docket),
respondents were asked about which extraction method they would expect
would be used to collect a product called ``spring water.'' In study 2
(MM5 in this docket), respondents were asked which extraction method is
used to collect ``spring water.''
Many comments criticized one or the other of the studies for the
way the different methods of extraction (borehole or surface
collection) were described to respondents, usually alleging that the
wording introduced a bias in respondents' answers. In study 1, for
example, surface extraction was described as ``water that flows
naturally to the surface,'' and bore hole extraction was described as
``water pumped * * * through a bore hole.'' In study 2, surface
extraction was described as ``water taken from springs whose water is
captured above ground level,'' and bore hole extraction was described
as ``water taken from springs whose water is captured below ground
level.''
FDA agrees that biases were introduced by the wording of these
questions. However, despite the difficulties in communicating to
consumers about methods of extraction for spring water in a telephone
survey, the results of both surveys show that there is considerable
uncertainty among consumers about which extraction method is or should
be used for spring water.
Study 1 asks the question, ``When you see spring water on the label
of a bottle, which of the following describes the water you would
expect to be in the bottle?'' in a forced-choice form such that ``not
sure'' answers are not allowed. Although 54 percent of respondents
responded that the water naturally flows to the surface, 46 percent of
respondents expressed the possibility that spring water was extracted
from a bore hole. In addition, even though the question context
strongly encouraged selecting one or the other of the alternatives
provided, 34 percent of respondents choose to answer ``either of the
above'' when asked which extraction method they would expect for spring
water. FDA considers this level of response to the ``either of the
above'' alternative to indicate considerable consumer uncertainty.
Because of the observed uncertainty, the study documents that there is
no consensus among consumers about how spring water is or should be
extracted.
In study 2, a ``not sure'' alternative was allowed for each of the
two yes/no questions, ``Is bottled spring water taken from springs
whose water is captured above the ground level?'' and ``Is bottled
spring water taken from springs whose water is captured below the
ground level?'' Forty one percent of respondents answered ``not sure''
to both questions, and an additional 13 percent answered ``not sure''
to one of the two questions. These responses mean that, overall, 54
percent of respondents indicated that they were not sure about the
extraction methods used for bottled spring water.
Given the high levels of consumer uncertainty about extraction
methods used for bottled water that were found in both studies, FDA
concludes that the issue of how spring water is or should be extracted
is not an issue to which many consumers have given much thought. At the
same time, however, FDA considers the finding that consumers have
limited opinions about the extraction methods used for bottled spring
water to be very relevant to its objective of developing bottled water
definitions that promote honesty and fair dealing in the marketplace.
The fact that consumers do not appear to be informed or concerned about
issues related to the extraction methods used for spring water suggests
that FDA has little reason to suggest major changes in the usage of the
``spring water'' designation on bottled water on the grounds of
promoting honesty and fair dealing in the marketplace. Currently, as
many comments stated, spring water products on the market are produced
using both methods of extraction. In addition, most State and
international definitions provide for both methods of extraction for
spring water (Comment 91 and Refs. 2, 7, 11, 12). Thus, FDA concludes
that the use of the term ``spring water'' does not imply a particular
extraction method, and that
[[Page 57090]]
providing for the use of either surface or bore hole collection of
spring water will not mislead consumers.
36. A number of comments cited survey results indicating that
consumers perceive that spring water has a higher quality and a better
taste than other kinds of bottled water, and that, therefore, consumers
are more likely to buy it. They argued that, because spring water has
greater consumer appeal, it is incumbent on FDA to ensure that the
definition of spring water is not misleading to consumers.
FDA agrees with these comments and with the conclusion, based
mainly on Study 1 findings, that consumers consider bottled water
labeled as spring water to be of a higher quality than other kinds of
bottled water. FDA notes, however, that the favorable state of consumer
opinion toward spring water has developed under circumstances in the
marketplace in which the term ``spring water'' has been used to
describe both water extracted at the surface and water extracted by the
bore hole method. Given that it has been extracted in both ways, with
apparent consumer satisfaction, how the water is extracted does not
appear to be the key factor.
There is a second aspect of the definition of ``spring water''--
from where the water comes. By the process of elimination, this factor
appears to be key. Thus, it is this aspect of the definition that FDA
has made most rigorous.
FDA concludes, therefore, that its requirement in
Sec. 165.110(a)(2)(vi) that bottled water labeled as ``spring water''
be from the same underground stratum as the spring and always have the
same physical properties, composition, and quality as water that flows
naturally to the surface of the earth, without specifying a necessary
method of extraction, will provide appropriate protection against use
of the term to mislead consumers about quality characteristics of
bottled water.
37. A number of comments, based principally on Study 2 findings,
argued that safety considerations were the primary consumer concerns
about bottled water, that FDA should take these concerns into account
when deciding on the appropriate definition of ``spring water,'' and
that these concerns provided a sufficient basis for including water
obtained by bore hole extraction in the definition of ``spring water.''
FDA agrees that safety considerations are important in the
regulation of bottled water. However, the agency does not generally
view the standard of identity for a product as the means to ensure its
safety. FDA stated in the proposed rule (58 FR 393) that it was
developing definitions for types of bottled water to ensure honesty and
fair dealing in the interest of consumers, and this remains the
agency's basic purpose for defining these terms.
FDA has established quality standards for bottled water to satisfy
consumer expectations that bottled water will be of appropriate
quality. To be of appropriate quality, the water must be safe. Thus,
the quality standard sets maximum levels that are well within safe
levels for a number of water contaminants. FDA has also adopted a good
manufacturing practice (GMP) regulation for bottled water to ensure
that bottled drinking water is processed, bottled, held, and
transported under sanitary conditions that will not render the product
injurious to health. Thus, regardless of the extraction method used to
obtain bottled water, the water will be safe.
For these reasons, FDA does not see consumers' concerns about
safety as a particular reason for including water that is obtained by
bore hole extraction in the definition of ``spring water.'' FDA is
including water obtained in this way in the definition because, as
explained above, bore hole collection of spring water is a common
industry practice, and consumers are not misled by the use of this
collection method. The key to the definition, as FDA stated in response
to comment 36 of this document is from where the water comes.
b. Use of a Bore Hole
38. A number of comments objected to a definition of ``spring
water'' that would allow the use of a bore hole to collect the water.
Comments stated that the definition would allow ``well water'' or
``bore hole water'' to be labeled as ``spring water.'' Comments
requested that the reference to bore hole extraction be deleted from
the proposed regulation because the water is not ``spring water.''
Some comments stated that ground water derived by the use of bore
holes is not compatible with the geological definition of a spring and
should not be permitted to be labeled as ``spring water.'' One of the
comments added that the proposed definition is inaccurate and does not
represent the common usage of this term by professional
hydrogeologists, professional ground water hydrologists, or the general
public. It stated that springs are naturally occurring discharges or
flows of ground water that occur at the land surface.
On the other hand, a number of comments argued that water extracted
through the use of a bore hole should be eligible to be called ``spring
water.'' Comments stated that a bore hole is a preferred method of
spring water collection, and that inclusion of this method of
collection in the definition of ``spring water'' would provide
flexibility to manufacturers. One comment from a hydrogeologist stated
that the use of bore hole collection methods is widely recognized
throughout the United States and the rest of the world as a safe,
convenient, sanitary, and reliable method for intercepting spring water
before it emerges to the earth's surface, where it can be exposed to
sources of pollution or alteration.
A number of comments noted that the use of bore holes has long been
recognized in this country, Canada, Europe, and elsewhere as a
preferred and sometimes necessary method for extracting spring water.
Comments stated that bore hole collection of spring water is practiced
exclusively in Europe and many other parts of the world for sanitary
reasons. Comments added that the proposed definition recognizes that
over 50 percent of the water used in domestic spring water production
is currently collected through the use of a bore hole, and that the
definition provides a consistent standard of identity regardless of the
technology used for extraction and collection.
One comment stated that some advance the view that spring water
collected at the surface is natural because its collection involves no
physical or technological intervention into, or development of, the
spring source or of the water, and that subsurface collection of spring
water is not natural because it involves extraction and piping through
a bore hole, which means that the finished product is produced through
physical alteration of, and intervention into, the source. The comment
said that this view is misleading because even when spring water is
collected at the surface, piping must be used, a bore must be drilled,
and technology must be employed in the collection process. The comment
said that frequently, physical alteration of the natural orifice also
must be undertaken.
The agency has decided to adopt the proposed definition of ``spring
water'' as water that is derived from an underground formation from
which water flows naturally to the surface of the earth. FDA has also
decided to provide that ``spring water'' may be collected below the
earth's surface through a bore hole. As previously discussed in
response to comment 35 in this final rule, consumers do not necessarily
believe that spring water is
[[Page 57091]]
collected at the surface of the earth. In addition, over half of the
spring water sold in the United States is extracted through a bore
hole. Therefore, the agency has concluded that providing for the use of
a bore hole in addition to surface collection will permit production
flexibility without interfering with established consumer understanding
or expectations in any way.
FDA recognizes that some geologists and hydrogeologists disagree
with the use of a bore hole in the collection of spring water. However,
FDA finds that as long as the physical properties, composition, and
quality of the water that is captured by a bore hole are the same as
those of the water from the same underground formation that flows to
the surface, it is appropriate to label the water as spring water. If
the use of a bore hole does not change the characteristics of that
water, then the bore hole is only tapping the underground water source
that feeds the spring. However, if the water collected through the bore
hole has different characteristics from the water emerging from the
spring orifice, the water is not spring water. To clarify that the
source of the water must be the same underground formation, the agency
is adding a provision to Sec. 165.110(a)(2)(vi) that the bore hole
collection of spring water must be through a bore hole tapping the
underground formation feeding the spring.
A spring is a natural flow of water from the earth (Ref. 13). An
aquifer is a porous rock stratum that yields water in a usable quantity
to a well or spring (Ref. 5). A stratum is a single layer of rock.
Spring water is water that emerges from the spring orifice or water
from the stratum that feeds the spring. Scientific field methods can
demonstrate that water that emerges from a spring and water from an
adjacent bore hole are from the same underground source. Geochemical
methods may be used to demonstrate that water extracted from a spring
and water extracted from an adjacent bore hole are of the same chemical
quality.
FDA agrees that there must be appropriate development of an
approved source, whether the water is to be collected at the natural
orifice or with the use of a bore hole. Both methods of collection
require careful engineering for proper water collection. A source must
be appropriately developed, in accordance with the GMP's in part 129,
to qualify as an approved source. Under Sec. 129.3(a), an approved
source is one that has been inspected by the State and local government
agencies having jurisdiction. Under Sec. 129.35(a)(1), the source must
be properly located, protected, and operated and be easily accessible
and adequate.
In summary, FDA finds that water that is collected by use of a bore
hole tapping the underground stratum of a spring is appropriately
included in the definition of ``spring water'' in
Sec. 165.110(a)(2)(vi), as long as the source of the water is the same
no matter which method of collection is used, and the method of
collection does not interfere with the quality or composition of the
water.
39. Comments contended that this rulemaking is being orchestrated
by parties who will profit from being able to legally increase their
production of spring water by using pumping mechanisms. One comment
stated that the reason that anyone would bore a well next to a spring
is because the flow of water from the spring has decreased. Another
comment added that the bottled water industry wants a loophole that
would allow companies to call their well water by the better perceived
term ``spring water.''
One comment stated that to allow ``spring water'' to be collected
through a bore hole that is adjacent to the point of emergence is being
less than honest with consumers. This comment maintained that allowing
this practice only serves the interest of a special segment of the
bottled water industry. The comment stated that when bore holes have to
be qualified to determine whether they are adjacent to the spring and
to determine whether the water is from the same underground stratum,
and has all the same physical properties, composition, and quality, as
the water emerging at the surface, then fair dealing will be lost in
the many ways that these provisions will be interpreted.
Conversely, a comment that supported the use of a bore hole stated
that adoption of the standard as proposed would protect consumers
against artificial barriers to commerce and restraints on competition
that ultimately raise consumer prices and reduce product quality.
Another comment stated that the controversy about the use of a bore
hole stems partly from a lack of understanding of practices accepted
around the world and partly by small companies striving to use
regulations for competitive advantages.
One comment asserted that differentiating between the same water,
whether it comes from a natural orifice or from a bore hole tapping an
aquifer, is an artificial marketing difference.
Some comments stated that if the definition of ``spring water''
were to preclude the use of bore holes, many smaller companies would be
constrained from expanding their businesses. These comments added that
as long as the water is compositionally identical, the method of
extraction is a production matter and should not be a factor in
classifying the water.
The agency disagrees with the comment that stated that consumer
interests would be compromised by providing for the use of a bore hole
in the definition of spring water. As discussed in the response to
comment 35 in this document, many consumers have not formed opinions
concerning an appropriate method of extraction of spring water, and,
based on information from the consumer surveys and other comments
received, FDA has concluded that consumers are not misled because of
the use of a bore hole.
FDA also disagrees that its position only serves the interest of a
special segment of the bottled water industry. Currently, as stated by
many comments, over half of the spring water produced in the United
States is collected through bore holes. Not providing for the use of a
bore hole in the definition of spring water would thus force a
significant segment of the industry to relabel their products as other
types of bottled water products. Given that most consumers are not
concerned about whether a bore hole or a spring collection box is used,
and that FDA can control the source of the water and its composition
and quality by means of its standard, the agency advises that it is not
aware of any factor that compels such a result.
In addition, the agency disagrees that its definition will provide
a loophole to allow water that is not spring water to be called
``spring water,'' with certain parties profiting from a broadened
definition. FDA's definition is no broader than the definition used by
most States, most notably the major bottled water-producing States of
New York, California, Texas, and Florida. These States already provide
for the use of a bore hole, although the State of North Carolina has a
stricter definition for ``spring water.'' Many foreign governments have
even broader definitions for ``spring water'' than is provided by FDA's
definition. For example, the government of the province of Quebec
defines ``spring water'' as ground water containing greater than 10 ppm
TDS and less than 500 ppm TDS, regardless of whether the water flowed
to the surface of the earth or was collected through a well. Therefore,
FDA concludes that its definition will not create a loophole to
[[Page 57092]]
market water that is not spring water. FDA's definition is generally
consistent with worldwide industry practice and most government
regulations. Thus, if anything, FDA's definition will help to eliminate
artificial barriers to competition and commerce.
Although how the determination of whether a bore hole actually is
tapping a spring is made may vary because of regional geological
differences (e.g., limestone formations versus granite formations), the
water collected from a bore hole must be the same water that feeds the
spring's natural orifice. To be called ``spring water,'' the water must
be from a stream that flows naturally to the surface of the earth. No
matter what method of extraction is used, the water must have the same
physical properties, quality, and composition as the water that
actually flows to the surface.
The agency recognizes that there is the possibility of a bore hole
extracting water from an aquifer that does not feed the spring.
However, the agency is requiring in Sec. 165.110(a)(2)(vi) that the
water be from the same underground stratum, retain all the physical
properties, and be of the same composition and quality as the water
that flows naturally to the surface of the earth. Water from a
different underground stratum will have different properties and
characteristics. Thus, the water will not meet the definition of spring
water unless it has the same properties and characteristics as the
water that flows through the spring's natural orifice. Therefore,
Sec. 165.110(a)(2)(vi) will protect against the possibility of a bore
hole extracting water that does not feed the spring.
40. Comments noted that a domestically produced beer that is
identical to a German beer could not be called German beer because it
does not come from Germany. They stated that, similarly, spring water
must come from a spring, not a bore hole.
Another comment maintained that under the law, ``the public is
entitled to get what it chooses, though the choice may be dictated by
caprice or by fashion or perhaps by ignorance'' (F.T.C. v. Algoma
Lumber Co., 291 U.S. 67, 79 (1934)). It concluded that bottlers should
not be allowed to tell consumers that a product is spring water when it
actually comes from a bore hole.
The agency disagrees with the comments. In the example of the
German beer, FDA recognizes that a German source does indeed make the
product a German beer, and that if the beer was not produced in Germany
the product would not be German beer. However, in the case of spring
water, the underground source of the water, that is, the spring, will
be the same whether collected at the surface or through use of a bore
hole. It is only the method of extraction that is different. Therefore,
water that is from an underground formation from which water flows to
the surface, and that has the same physical properties, quality, and
composition as the water that flows to the surface, is fairly and
appropriately considered to be spring water even if it is extracted by
use of a bore hole.
41. Several comments stated that natural spring water is free
flowing, and that if a bore hole is used by a bottler, it should be so
noted on the label to allow consumers to make the ultimate decision on
this issue.
Other comments suggested that to differentiate between spring water
that is naturally flowing and spring water that is collected from a
bore hole, FDA should define ``natural spring water'' as water that is
derived from an underground formation from which water flows naturally
to the surface of the earth and ``spring water'' as water derived from
an underground source from which water flows naturally or through a
bore hole adjacent to the point of emergence. One comment added that to
not differentiate between ``natural spring'' and ``spring'' waters
would be to perpetuate a fraud.
The agency disagrees with the comments. As defined in
Sec. 165.110(a)(2)(vi), the underground source of ``spring water'' must
be the same whether it is extracted from the natural orifice or from a
bore hole. In addition, as shown by the submitted surveys, many
consumers did not object to the use of a bore hole to extract spring
water. Therefore, it is not necessary to establish mandatory labeling
regulations to distinguish between spring water extracted through a
bore hole or through the natural orifice. However, FDA would not object
to a truthful, nonmisleading statement on the label that stated that
the water flowed naturally to the surface, if indeed the water was
extracted from the natural orifice without the use of external force,
or to a statement that the water was extracted through a bore hole.
42. One comment suggested that bore hole-collected water more
clearly fits the definition of ``artesian well water.'' It stated that
FDA defined the other types of water with their proper historic
geologic definitions, and that spring water should also be defined in
this manner.
The agency disagrees that spring water collected from a bore hole
more clearly meets the definition of ``artesian water.'' The definition
for ``spring water'' mandates that the water come from an underground
source where water flows naturally to the earth's surface before the
drilling of a bore hole. Artesian water comes from a well tapping a
confined aquifer. Artesian water does not flow to the earth's surface
unless a well is drilled to tap the source, and the natural hydraulic
pressure is great enough to force the water to the earth's surface.
Therefore, spring water and artesian water are from distinct sources.
However, to clearly distinguish between the definitions of ``artesian
water'' and ``spring water,'' FDA is modifying Sec. 165.110(a)(2)(vi)
to state that there must be a natural force causing the water to flow
to the surface through a natural orifice for the water to be labeled as
``spring water.''
c. Adjacency
43. Some comments asked how one could be assured that water
collected through a bore hole would have emerged from the ground
through a free-flowing spring at a point adjacent to the bore hole had
it not been extracted through the bore hole.
Several comments suggested that FDA incorporate a requirement for
hydrogeological data to demonstrate a hydraulic link between a bore
hole and a spring to document that the source is a spring. One comment
added that the spring water definition will not resolve the matter of
whether a bore hole is adjacent to a spring unless scientific support
for the term ``adjacent'' is presented.
Some comments suggested specific methods to determine the hydraulic
linkage. These included using dye tracer tests, geophysical
conductivity tests, water analyses, and graphical methods, such as the
Stiff diagram and the Piper trilinear diagram, to demonstrate that the
chemical and physical characteristics of the water correspond to those
of the spring. Comments stated that pumping should cause a measurable
decline in the spring's discharge rate if the well is tapping spring
water, although if the withdrawal rate from the bore hole is small
relative to the discharge rate of the spring, or if the spring is
submerged, this decline may not be measurable.
The comments stated that because of the differences in the mineral
composition of geological strata, no one set of analyses will apply to
all spring formations to demonstrate compliance with these criteria.
Some comments suggested that the criterion of adjacency used in the
hydrogeological context of hydraulic connection is reasonable and
logical and objectively addresses this important and
[[Page 57093]]
controversial issue. They requested that language be added to the
regulation to require that bore hole adjacency to the spring be
verified by its measurable hydraulic influence on the spring flow from
the natural orifice at the time of collection, as certified by a
professional hydrogeologist.
However, some comments asserted that it will be difficult to
establish the uniformity or sameness of actual spring water and water
collected through an adjacent bore hole.
The agency agrees that hydraulic linkage is important in the
definition of ``spring water.'' If the bore hole taps the same
underground water source as that which feeds the natural spring, and
has the same physical properties, composition, and quality as the water
emerging from the natural orifice, it is clear that the location of the
bore hole relative to that of the point of emergence is not relevant.
However, a bore hole adjacent to a natural emergence can actually tap
another water bed far below the aquifer feeding the natural spring
source and thus collect water of a totally different composition from
that of the water which emerges from the natural spring.
The agency concludes that requiring a hydraulic (i.e., physical)
connection between a bore hole and a spring will clarify the definition
of spring water and will eliminate the possibility of indiscriminate
bore hole use. Therefore, FDA is modifying its definition of ``spring
water'' in Sec. 165.110(a)(2)(vi) to require that a measurable
hydraulic connection, using a hydrogeologically valid method, between
the bore hole and the natural spring be established to show that the
water is from the same underground stratum as the spring.
The comments suggested several different methods to determine
hydraulic linkage. One or more hydrogeologically valid methods may be
used as appropriate to determine hydraulic linkage. However, not all
methods may be appropriate for different geologic regions or for the
specific bore hole site. Therefore, the agency is not recommending or
requiring any specific method or methods.
44. Some comments stated that the location of the bore hole
relative to that of the point of emergence is not relevant as long as
the bore hole taps the same underground water source as that that
feeds, or that would feed, the natural spring if not for the collection
below the earth's surface. Other comments objected to the use of the
word ``adjacent'' in the definition because they believe that it is
ambiguous. Comments suggested that the agency modify the definition for
``spring water'' to delete the use of the term ``adjacent.'' One
comment added that such a definition would be easier to enforce and
would eliminate the need to arbitrarily decide what ``adjacent'' means
in terms of a measurable distance.
Conversely, one comment stated that if bore hole access is
permitted in the final definition of ``spring water,'' then it is
crucial to retain the requirement that the bore hole be adjacent or
near to the point of natural emergence of the spring. The comment
stated that this requirement is necessary to assure that the bore hole
is tapping only water that would otherwise emerge at that point, and
that consumers are not misled that they are purchasing spring water
from a specifically identified spring source.
The agency agrees with the comments that suggested that the term
``adjacent'' be deleted from the definition of spring water. As
discussed in the previous comment, the agency is requiring that there
be a measurable hydraulic connection, using a hydrogeologically valid
method, between the bore hole and the natural spring established to
show that the water is from the same underground stratum as the spring.
To meet the definition of ``spring water,'' the manufacturer must
ensure that the water collected through a bore hole is from the same
underground stratum as the spring and has the same physical properties,
composition, and quality as the water that flows naturally to the
surface of the earth from the spring. Water collected at a distance
from the natural orifice will not have traveled the same path as the
water that flows from the natural orifice of the spring and, therefore,
could have a different composition. FDA is accommodating the use of
bore hole technology so long as there is assurance that the water from
the bore hole has the same composition and characteristics as the water
from the natural orifice. If the bore hole is too far from the natural
orifice, the latter assurance would not exist.
FDA concludes that the requirement of a measurable hydraulic
connection between the bore hole and the spring's natural orifice
adequately encompasses the intent of the proposed adjacency
requirement. Therefore, the agency is deleting the requirement in
Sec. 165.110(a)(2)(vi) that the bore hole be adjacent to the point of
emergence of a spring.
45. A number of comments asked FDA to explain or define the terms
``adjacent'' and ``point of emergence.'' Comments requested that FDA
designate a specific distance (e.g., 50 feet, 100 feet, 250 feet, 1
mile) for how far bore holes could be located from the source and still
meet the criterion of ``adjacent to the point of emergence.'' One
comment suggested that a person should be able to see the spring and
bore hole at the same time. Some comments held that the rule should
specify that the bore hole must be as close as possible to a
specifically identified spring discharge, and that the bore hole must
be closer to the spring discharge than to any other source of ground or
surface water.
One comment stated that the State of California informally defines
``adjacent'' as a distance of approximately 250 feet. It stated that
this definition avoids cases of confusion, such as the installation of
spring bore holes several miles from the spring location. Other
comments stated that some States have used a ballpark figure of 200
feet for adjacent, others more or less than 200 feet.
Another comment stated that the reasoning provided in the preamble
of the proposal necessitates a relatively narrow interpretation of
``adjacent'' as a point located a minimal distance from the spring
orifice and asked that a statement to this effect be included in the
regulation.
In the preamble of the January 1993 proposal (58 FR 393 at 399),
FDA stated that allowing for a bore hole adjacent to a spring would
provide for the tapping of the source at a point near the mouth of the
spring. The agency is not specifying a particular distance between a
bore hole and the mouth of the spring because the appropriate distance
will vary significantly in different geological areas. FDA is also not
adopting a requirement that a person be able to see the spring and bore
hole at the same time because, depending on the terrain, a person may
be able to see a great distance or only a small distance. Therefore,
FDA finds that defining ``adjacent'' in these terms would not be
appropriate. As discussed in the previous comment, the agency is
defining adjacency in terms of a measurable hydraulic connection.
FDA agrees that the collection apparatus should be as close as
possible to the specifically identified spring discharge. The agency
also agrees that the bore hole should normally be closer to the spring
discharge than to any other source of ground or surface water. However,
the agency does not agree that this distance need be specified in the
regulation because it is requiring that a measurable hydraulic
connection, using a hydrogeologically valid method, between the bore
hole and the natural spring be established to show that the water is
from the same underground stratum as the spring
(Sec. 165.110(a)(2)(vi)). The agency
[[Page 57094]]
concludes that the requirement for a hydraulic connection is
appropriate and avoids uncertainty concerning any specific distance
implied by the term ``adjacent.''
46. Comments requested that FDA address the issues of ownership and
control in the regulations. Comments questioned whether proper
inspections could be mandated in a case where a spring is located on
one owner's property, and the bore hole is on another's property. One
comment stated that the ownership and control of the bore hole should
be the same as that of the spring for quality control purposes. One
comment stated that, if a company owns, or owns the rights to, a
legitimate spring, it should not matter how it collects the water as
long as it does so in a sanitary way.
The issues raised by these comments are outside the scope of this
rulemaking and really beyond the coverage of the act. Issues of
ownership and control turn on property laws, water rights, and access
to the spring's natural orifice. However, FDA cautions that a
manufacturer must be able to test the water that flows naturally to the
surface of the earth to ensure that the water that it is collecting
from the bore hole is the same water as that from the spring that flows
to the surface, and that there is a hydraulic connection between the
bore hole and the natural spring. If the manufacturer cannot establish
that the water that it is calling ``spring water'' is the same as that
from the identified spring, it runs a significant risk that its product
is misbranded, and, thus, that it will be the subject of a regulatory
action.
d. External Force
47. Several comments objected to the use of external force in the
collection of spring water. One of the comments stated that consumers
believe that spring water has no unique taste, color, or other
characteristic other than being water that comes to the surface through
a natural orifice, and that most believe that the water flowed to the
surface by the spring's natural pressure. Comments stated that to
furnish other than a natural flow rate by supplemental pressure is
misleading, and that such a product should be labeled as ``well
water.''
Comments stated that the use of a bore hole is appropriate only if
external force is not used. One comment stated that the freely flowing
water from a natural spring site represents the overflow of the
underlying aquifer, and that, by contrast, pumped water from a vertical
well of arbitrary depth may tap many hydrogeologic layers, drawing
against the storage of the aquifer. The comment asserted that some
trace of the natural flow should be visible at the original spring
orifice.
One comment stated that some of the problems associated with pumped
wells are: (1) The cone of depression caused by pumping an unconfined
aquifer triggers a series of changes in the ground water and aquifer;
(2) dewatering the aquifer around a well allows air intrusion into the
formation voids, which can oxidize iron and other metals resulting in
reduced water storage capacity, thereby increasing the size of the cone
of depression; (3) pumping from an aquifer that yields water to a
spring can induce recharge from neighboring hydrogeologic units that
are not normally hydraulically connected to the spring; and (4) pumping
an aquifer causes changes in flow velocity and direction of flow and
creates turbulence.
The agency does not agree that the use of external force should be
prohibited for the extraction of spring water. Although there must be a
natural force that causes at least some of the water to flow to the
surface through a natural orifice, this force may not be sufficient to
cause the water to flow through some bore holes. The angle and the
distance of the bore hole from the mouth of the spring may not provide
adequate water pressure for the water to flow through the bore hole.
It is true, as described by the comment, that changes may occur in
the underground strata as a result of pumping. The creation of a cone
of depression, changes in water flow, and the nature of the recharge
can alter the composition of the ground water. However, if the
properties of the water change as a result of the use of external
force, the water is no longer spring water because the water is no
longer the same water that flows through the natural spring orifice. If
pumping action alters the properties of the water, pumping will have to
cease, and the area allowed to return to its natural equilibrium, so
that water collected from the bore hole with the aid of external force
will once again have the same properties as the water flowing from the
natural spring orifice. If not, while pumping may continue, the water
can no longer be labeled as ``spring water.''
Finally, the agency points out, in response to one comment, that if
water is pumped from a vertical bore hole of any depth that taps other
hydrologic strata, that water is not spring water.
FDA concludes that the use of external force in the collection of
spring water is not misleading to consumers because the agency is
requiring in Sec. 165.110(a)(2)(vi) that the water be derived from an
underground formation from which water flows naturally to the surface
of the earth; that the water have the same physical properties,
composition, and quality as the water that emerges from the natural
orifice; and that there be a hydraulic connection between the bore hole
and the spring stratum. Thus, the agency concludes that the definition
will ensure that water labeled as ``spring water'' meets consumers'
expectations.
48. Three comments stated that FDA should require that the spring
continue to flow to the surface naturally. They stated that if the
spring ceases to flow for a period of 90 days, then the water from the
bore hole should no longer be considered to be spring water, and any
labeling of the product as such must cease. One of the comments stated
that such a requirement would help to ensure the integrity of the
spring source and prevent contamination caused by a reversed flow close
to the ground surface.
One comment stated that if the spring ceases to flow to the earth's
surface, the pumping mechanism is at fault, and comparative samples
would not be available. Another comment asked whether, if the spring
ceases to flow as a result of pumping, the water may still be called
``spring water.''
The agency agrees with the concerns of the comments. In some cases
pumping may cause the spring to cease flowing through the natural
orifice, and, thus, comparative samples of the water would not be
available because of the use of external force when the water is
collected through a bore hole. It is important to maintain some flow of
water through the natural orifice to prevent any reverse flow of
surface water, which could then be pumped through the bore hole. As
previously stated in the response to comment 12 of this document,
ground water under the influence of surface water cannot be called
``spring water.''
FDA recognizes that occasionally a spring may cease flowing
temporarily because of fluctuations in ground water levels. Ground
water fluctuations may be caused by natural conditions (e.g., drought)
or man-induced (e.g., pumping) and are classified as short-lived,
diurnal, seasonal, and long-term changes (Ref. 9). If the spring has
ceased flowing, and this cessation is not a temporary condition, the
water is not spring water. In addition, if the external force is
routinely (e.g., more often than during the time of year when the water
table is typically low) causing cessation of the spring's flow to the
surface, this too is not a temporary condition, and
[[Page 57095]]
the water does not qualify to be called ``spring water.''
The State of Florida's definition for ``spring water'' does not
include water from a strata feeding a spring that ceases to flow
naturally to the surface for a period of 90 days (Comment 184). The
agency agrees that there must be an expectation that the spring will
continue to naturally flow to the surface for the water to qualify as
spring water. Thus, any cessation in the flow of the spring from the
natural orifice must be for a limited period of time. Ninety days is an
appropriate time limit for seasonal types of changes in ground water.
However, the agency will consider each situation on a case-by-case
basis and take into consideration all circumstances (e.g., climatic
conditions and effect of pumping) causing the flow cessation.
To clarify in Sec. 165.110(a)(2)(vi) that the spring must continue
to flow when external force is applied to a bore hole in the collection
of spring water, FDA is deleting the statement that it included in the
proposed regulation that the water would flow naturally to the surface
of the earth if not for its collection below the earth's surface. In
addition, the agency is adding a requirement in Sec. 165.110(a)(2)(vi)
that if spring water is collected with the use of external force, water
must continue to naturally flow to the surface of the earth through the
spring's natural orifice.
49. A number of comments expressed concern that the use of external
force will allow a spring water bottler to extract more water from the
ground than would have naturally flowed to the surface of the earth
through the spring's natural orifice. Comments requested that the
agency include a provision in the definition of ``spring water'' to
require that the quantity of water extracted through external force not
exceed the quantity of the water that would flow naturally to the
surface of the earth if not for its collection below the earth's
surface.
Two comments asked what the purpose of permitting the use of a bore
hole was if the quality of the water from the bore hole must equal that
of the water that flows naturally to the earth's surface except to
enable the pumping of larger volumes of water from a stratum. Another
comment held that under the proposed rule, there will be few springs
developed with collection boxes because bore holes will be generally
more economically advantageous, and greater volumes of water will
normally be available through the use of bore holes than through the
use of collection boxes.
One comment added that provision for the use of bore holes could
encourage bottlers to exceed the safe yield from the spring's aquifer.
It stated that excessive withdrawal is usually discussed in terms of
``mining'' of the water (defined as when more water is withdrawn than
is replaced by recharge). The comment stated that the real issue as far
as surface contamination is concerned is not the ``mining'' of water or
the collection device but the quality and purity of the aquifer as
determined by the source of recharge.
One comment expressed concern that the proposed rule is silent on
any method to identify when, because of overpumping, wells are
capturing water that would otherwise not flow to the spring. It stated
that overpumped bore holes (i.e., those that pump more water than the
spring naturally discharges) could induce flow from surface water or
nearby contaminant sources, such as septic tanks. The comment stated
that possible solutions to this problem would be to: (1) Restrict the
allowable daily pumping volume to that volume equal to the natural
average (mean) daily flow from the spring; (2) restrict the use of bore
holes to those that do not require the ``assistance of external force''
(i.e., pumping); or (3) require a demonstration that any additional
pumping is not altering the flow paths to the spring such that flow is
induced from nearby potential sources of contamination to the well.
FDA agrees that there may be adverse effects of overpumping (i.e.,
mining) a bore hole that is tapping a spring. There may be public
health concerns if the recharge to the aquifer is contaminated by
surface water. In addition, ground water extracted with external force,
and under the direct influence of surface water because of overpumping,
is not spring water because the source of the water is not entirely the
source that feeds the spring. However, such water may be treated and
called ``bottled water'' or another applicable name.
FDA does not object to the use of external force, and does not deem
it necessary to restrict the amount of water that may be extracted
through the use of external force, as long as the water meets the
requirements of Sec. 165.110(a)(2)(vi) (e.g., it is compositionally the
same as the water flowing from the natural orifice). Water that has not
traveled the same course as the water feeding the spring, and, thus,
that does not have the same characteristics as water from the spring,
cannot be labeled as ``spring water.''
The agency disagrees that allowing the use of a bore hole and
external force will decrease the number of springs developed with
collection boxes. Many States already allow the use of both extraction
methods, and both methods are already used by manufacturers. Providing
for the use of both methods of collection of spring water allows
manufacturers the flexibility to use the method best suited for their
spring site.
A demonstration that pumping is altering the flow paths to the
spring, such that flow is induced from nearby potential sources of
contamination to the bore hole, could include bore hole pump tests,
monitoring of observation wells, and ground water flow modeling. EPA's
Ground Water Protection Division has developed a variety of tools
designed to assist State and local governments in the task of
identifying the capture zones of pumping as part of the Wellhead
Protection Program (WHPA). A capture zone is the area around a bore
hole containing ground water that is destined to flow to that bore hole
within a specified time. EPA's existing ground water flow model (WHPA
2.1) can identify induced flow from surface water caused by changes in
pumping rates. Should a demonstration of the effects of pumping be
required, this model could be used as a tool by government agencies to
determine the impact of the aquifer's recharge. FDA concludes that a
ground water flow model could be used to ascertain whether allowable
overpumping is inducing deleterious results. However, regardless of the
use of external force to extract spring water, the water must still
comply with the definition in Sec. 165.110(a)(2)(vi) to be labeled as
``spring water.''
e. Source Approval and Enforcement Issues
50. Comments asked how it can be proven that the water from the
bore hole is from the same stratum as the water that is actually
emerging from the spring. They stated that once the bore hole at the
spring has been constructed and the establishment is in operation, it
would be difficult to verify that the water from the bore hole met the
definition of spring water. One comment asked what type of
documentation the producer could keep that would satisfy the
requirements of the regulation concerning source. It asked whether the
records or a certification statement from the drilling company that
drilled the holes would be necessary, or whether a site examination and
the manufacturer's word on source would be adequate.
One comment expressed concern about potential abuse from the use of
a bore hole because the nonexistence of a
[[Page 57096]]
spring can be readily attributed to the effect of the bore hole, and no
confirmation of the prior existence of a spring at that location is
required.
The agency acknowledges the concerns of the comments. Section
129.35(a)(1) states that the product water supply for each plant shall
be: (1) From an approved source that is properly located, protected,
and operated; (2) easily accessible, adequate, and of a safe, sanitary
quality; and (3) in conformance at all times with the applicable laws
and regulations of the government agency or agencies having
jurisdiction. However, part 129 does not require that the government
agency having jurisdiction identify or certify that the source is a
spring source.
As discussed in the response to comment 48, FDA has modified
Sec. 165.110(a)(2)(vi) to mandate that the spring continue to flow,
although it may be at a diminished rate, for the product to qualify as
``spring water.'' In addition, it is important that manufacturers
identify the location of the spring to determine that the water is, in
fact, flowing and, thus is spring water. A spring is a flow of water
from the earth. If there is no identifiable spring, the water can not
be labeled as ``spring water.'' Thus, it is critical that manufacturers
of ``spring water'' identify the exact location of the natural orifice
where the spring flows from the earth. Therefore, the agency is
modifying Sec. 165.110(a)(2)(vi) to include a requirement that the
location of the spring be identified.
There must be other means of verifying labeling claims once the
bore hole at the spring has been constructed, and the establishment is
in operation. As discussed above under ``1. Artesian Water,'' the
agency may promulgate regulations for the efficient enforcement of the
Act under section 701(a) of the Act. Although it is possible to
determine that a source of water is a spring after the bore hole is in
operation, in some cases it would be onerous for regulatory officials
to do so. Therefore, FDA has determined that a requirement to
demonstrate the hydraulic connection between the bore hole and the
spring's natural orifice is necessary for the efficient enforcement of
the Act.
As FDA has stated, a food manufacturer is responsible for the
accuracy of its food labels (58 FR 2079, 2163, and 2165 January 6,
1993). Indeed, placing a claim in food labeling that calls the
consumers's attention to a water's source is a representation that the
manufacturer has evidence that the product meets the requirements for
the claim. See Thompson Medical Co., Inc. v. FTC, 791 F.2d 189, 193
(D.C. Cir. 1986), cert. denied, 479 U.S. 1086 (1987). Thus, making a
claim without such a basis would be misleading and in violation of
section 403(a) of the Act.
The evidence that manufacturers compile in response to the
requirement in Sec. 165.110(a)(2)(vi) that they be able to demonstrate
to regulatory officials that a measurable hydraulic connection exists
between the bore hole and the natural spring orifice (see comment 43 of
this document) should also establish that the spring is the source of
water for the bore hole. To comply with this requirement, producers may
maintain records that demonstrate that a measurable hydraulic
connection does indeed exist between the natural orifice and the bore
hole. In addition, many States and the United States Geological Survey
may have records of the development of some springs and the geology of
the surrounding area. Records or a certification statement from a
professional hydrogeologist or the drilling company that drilled the
holes are appropriate sources of documentation. In addition,
manufacturers may use methods such as the dye tracer test to
demonstrate the hydraulic connection during an inspection.
If the source does not meet the definition of spring water then the
product must not be labeled as ``spring water,'' or it is misbranded
under sections 403(a), 403(b), and 403(g) of the Act. Compliance with
this provision does not entail the creation of any new information or
the compilation of any special records. Rather, the requirement would
obligate manufacturers simply to have access to information that they
should already possess and be able to provide FDA with this information
upon request.
51. Several comments expressed concern about the requirements that
spring water be ``from the same underground stratum,'' ``retain all the
physical properties,'' and ``be of the same composition and quality.''
They stated that these requirements are too general and are undefined,
leaving many questions relative to acceptable differences in such
parameters as temperature, pH, turbidity, hardness, iron content, and
calcium content. One comment stated that it will be difficult for FDA
or any other government agency to monitor the conditions required for
``spring water.''
One comment requested clarification of the requirement in part 129
that product and source waters be approved by State regulatory agencies
having approval authority. It asked whether the proposed regulations
mandated approval of the bore hole and the spring, whether the spring
must be validated as a natural spring, and whether engineering had to
be performed to protect the spring site if a bore hole is to be
utilized. The comment stated that there is no reference to continuous
maintenance of the spring. Comments asked how many, and at what
frequency, tests are necessary to show that water from the bore hole is
identical to water from the spring.
Comments stated that manufacturers should present geological
information about the vicinity of the orifice and bore hole so that the
State can devise a representative set of water quality analyses
specific to the situation.
FDA notes that the source is approved by the government agency or
agencies having jurisdiction (Sec. 129.3(a)), and that in many cases,
it will be a State agency. However, the approval mandated under part
129 is to inspect the source and sample the water to ascertain that the
water is of a safe and sanitary quality. Firms are responsible for
ensuring that their products comply with the particular source
requirements in Sec. 165.110(a)(2)(vi). As discussed previously, the
bottled water firm must be able to demonstrate to regulatory officials
that a measurable hydraulic connection exists between the bore hole and
the natural spring, and that the water complies in all other respects
with Sec. 165.110(a)(2)(vi).
Concerning continuous maintenance of the spring, the firm is
responsible for ensuring that their products comply with all applicable
regulations. The quality of the source water is critical to the quality
of the final product. Without proper maintenance of the spring, the
quality of the source water will decrease, and the firm is taking a
risk that the water will not meet FDA requirements. Thus it is in the
interest of the firm to maintain the source in appropriate condition.
In regards to methods of testing for comparative purposes, one or
more hydrogeologically valid methods may be used as appropriate to
verify that the product is in compliance. However, not all methods may
be suitable for different geologic regions or for the specific bore
hole site. Therefore, the agency is not recommending or requiring any
specific method or methods.
Under Sec. 165.110(a)(2)(vi), manufacturers must be able to
demonstrate, upon request, to regulatory officials that there is a
measurable hydraulic connection between the natural spring and the bore
hole. This verification must be current to be satisfactory. It is the
responsibility of the firm to be in compliance at all times.
[[Page 57097]]
52. Two comments asked for clarification of whether water emerging
at the surface not as a result of flow from an underground formation or
aquifer, but as the result of seepage from a higher elevation surface
water source reemerging at a lower elevation, is really spring water
(e.g., springs fed by higher level lakes; underground creeks popping up
to the surface; or other surface water that originates high in a
mountain which emerges at a lower elevation).
The agency considers that surface water from a higher elevation
reemerging through a natural orifice at a lower elevation is spring
water if the water has traveled sufficiently through the ground so as
not to be under the direct influence of surface water. According to 40
CFR 141.2, ground water under the direct influence of surface water
means any water beneath the surface of the ground with: (1) Significant
occurrence of insects or other macroorganisms, algae, or large diameter
pathogens such as Giardia lamblia; or (2) significant and relatively
rapid shifts in water characteristics such as turbidity, temperature,
conductivity, or pH which closely correlate to climatological or
surface water conditions. The existence of any of these factors
indicates that the source is under the direct influence of surface
water and is, therefore, not a ground water source that meets the
definition of ``spring water.''
A spring is water from an underground source that flows naturally
to the surface of the earth. Under normal conditions, aquifers feeding
springs are in a stable environment. On the other hand, surface water
is subject to a changing environment and may assimilate these changes.
Thus, if water flowing naturally to the surface of the earth exhibits
the characteristics of surface water, it does not comply with the
definition of ``spring water'' in Sec. 165.110(a)(2)(vi) and is not
spring water.
53. One comment claimed that some members of industry consider any
wet location on an otherwise dry mountainside or flat pasture to be a
spring. The comment stated that sometimes these wet spots can bead
water, producing a small trickle. The comment contended that after
development, these wet spots can sometimes produce a considerable flow
of water. It also stated that water has been known to come up in
natural depressions in hillsides without flowing until the water is
pumped. The comment requested clarification on these questions. It
asked whether any alteration to the natural terrain that results in
water coming spontaneously to the surface of the alteration should be
deemed a spring (e.g., a road cut into a mountain and in this cut water
trickles (or gushes) out).
FDA is defining ``spring water'' in Sec. 165.110(a)(2)(vi) as water
derived from an underground formation from which water flows naturally
to the surface of the earth. There must be a natural force causing the
water to flow to the surface through a natural orifice. If the water
does not flow to the surface of the earth from the underground source
without development of the area or the use of external force, then the
water does not qualify for use of the name ``spring water.''
54. One comment complained that the January 5, 1993 proposal, if
adopted, would be yet another Federal mandate, without Federal funding,
to State agencies having the responsibility of ensuring compliance. It
stated that justification for additional program expenditures must be
based on need and public safety. The comment stated that there has been
no evidence presented that adoption of the proposed rules would
increase product safety.
One comment stated that the very general nature of FDA's proposal
would create problems for regulatory agencies attempting to implement
and enforce the rule by generating additional workload, controversy
within the bottled water industry, and legal battles over whether a
``bore hole'' is tapping ``spring water'' or ``well water.''
Comments stated that the use of a bore hole in the collection of
spring water would make enforcement of the provision not only expensive
but most difficult.
The agency disagrees that it is imposing a burden on State
regulatory agencies by establishing a standard of identity for spring
water. There is no requirement that a State ensure that a firm is
complying with FDA regulations. However, a State may elect to enforce
Sec. 165.110 under section 310(b) of the Act (21 U.S.C. 337).
In response to comments, the agency has added provisions to its
definition of spring water that make it more specific and that should
make its requirements more understandable both to the regulated and the
regulators. Manufacturers must identify the location of the spring;
there must be evidence that the water is flowing naturally to the
surface through a natural orifice; firms must demonstrate and be able
to verify to regulatory officials that there is a measurable hydraulic
connection between the bore hole and the natural spring; and water must
continue to flow naturally to the surface of the earth through the
springs' natural orifice. FDA concludes that these provisions will aid
in enforcement of the definition of ``spring water.''
f. Contamination and Sanitary Bottling
55. A number of comments disagreed with FDA's statement in the
preamble to the proposal that use of a bore hole will reduce the
possibility of contamination and is an aid in the sanitary bottling of
spring water (58 FR 393 at 399). Two comments argued that the available
evidence did not support that a bore hole is a more sanitary method to
collect spring water than a collection box. Comments stated that a
properly engineered and constructed spring collection box system can
adequately protect a natural spring from outside microbial
contamination.
A comment stated that if the quality of spring water is an issue,
then it can and should be addressed by quality standards rather than by
altering the common definition of spring water to permit use of a bore
hole. It argued that the evidence of record on this rule does not
justify any departure from the accepted definitions of ``spring'' and
``spring water.'' Another comment stated that with respect to bore
holes serving as an aid in the sanitary bottling of the water, FDA
already has provisions for this purpose in part 129. It stated that
bore holes as aids in sanitary bottling of water should not be a
consideration under the standard of identity.
Another comment stated that the proposed rule provides no
specifications for the construction of bore holes, and that, if
improperly constructed, sources of contamination could enter the
aquifer through the bore hole. It stated that the technology exists to
protect a spring water source at its point of discharge, and that
treatment systems can be incorporated at the point of discharge to
provide protection from a number of types of potential contaminants.
The agency points out that both properly engineered and constructed
bore holes and properly engineered and constructed spring collection
boxes are appropriate methods to collect spring water. However, in some
circumstances, use of a bore hole instead of a collection box will
reduce the possibility of contamination and thus aid in the sanitary
bottling of the water. For example, springs may surface in areas where
it would be difficult to collect the water at the orifice without
contaminating the water. In such cases, use of a bore hole can be an
effective means to extract the water in a sanitary manner. In all cases
the processing and
[[Page 57098]]
bottling of drinking water must comply with part 129.
FDA agrees with the comments that stated that sanitation is a
function of GMP and not a standard of identity. The agency stated in
the preamble of the proposed rule that the use of a bore hole would
reduce the possibility of contamination and would be an aid in the
sanitary bottling of the water (58 FR 393 at 399), but the intent of
this statement was not to say that use of a bore hole is a superior
method of collecting the water. Rather, the agency was saying that even
though the geological definition of ``spring water'' does not provide
for bore holes, it is a good idea to include their use in the
definition of ``spring water'' because it would provide an alternative
sanitary means of extracting the water. Thus, the statement was
intended to be a basis for what the agency was proposing to do, not to
be an end in itself. The usefulness of bore holes is one of several
factors that have convinced the agency that it is appropriate to
include water collected by means of their use in the definition of
``spring water.''
External force is often used with bore holes to extract the water.
To clarify the agency's intent that use of bore holes, including those
using external force, or properly engineered and constructed spring
collection box systems must adequately protect the water, FDA is
modifying Sec. 165.110(a)(2)(vi) to remove any inference that
manufacturers may use external force to protect the water. Under part
129, any method of collection of spring water must protect the water
(Sec. 129.35(a)(1)).
The agency is not providing detailed specifications for the
construction of bore holes or for the construction of spring collection
boxes. Appropriate construction specifications may vary according to
the site. However, construction of either type of collection mechanism
must be in accordance with current good engineering practice. In
addition, under Sec. 129.3(a), the source water must be of a safe and
sanitary quality. Proper construction will greatly assist in complying
with this requirement.
56. Comments asserted that a main concern is that drilling a bore
hole next to a free flowing spring orifice may create a hydraulic
connection or direct communication between any nearby surface water
(river, creek, lake, pond, or swamp) and the spring source and, thus
serve only to increase the risk of contamination. Comments were
concerned about altering the patterns of recharge by the use of
external force and lowering the quality of the water as a result. One
comment stated that the use of bore hole collection systems runs
contrary to the standards set by EPA regulations (40 CFR part 141)
because, almost by definition, the bore hole will be shallow, and it
can be sited near surface waters created by the discharging spring.
Conversely, one comment stated that, in a properly equipped bore
hole, reverse ground water flow from the surface should not occur. It
stated that pumping may change the flow of ground water in a horizontal
direction within the aquifer, specifically within the cone of
depression created by pumping, and that if a bore hole is properly
equipped and managed, vertical movement of surface water downward into
the screen will not occur. It added that properly equipped bore holes
are accepted by both Federal and State agencies as safe supplies of
both domestic and municipal drinking water.
FDA agrees that the potential exists for improper recharge of an
aquifer feeding a spring. Water recharge is an issue that must be
considered during source approval because there is the potential that
the recharge may come from surface sources that may contaminate the
underground source. For source approval, the government agency having
jurisdiction must determine whether the water will be of a safe and
sanitary quality. The States, however, have experience with issues of
this type.
The establishment of a definition for ``spring water'' does not
have any effect on the State's burden in reviewing a site for approval,
whether a bore hole or a collection box is to be used. The State's
decision on whether to approve a source has nothing to do with how
water collected from that source and bottled is to be labeled. That
decision is made by the bottler, subject to the definitions in
Sec. 165.110(a)(2)(vi) and the scrutiny of FDA.
57. One comment stated that the language of the proposed rule
creates the impression that spring water may be collected from the
surface, which is unlikely, and that bottlers may bottle untreated
surface water. The comment stated that surface water intended for
drinking must undergo treatment that may result in alteration of the
original chemical properties of the water, which would destroy the
product's identity as ``spring water'' in the public's perception. It
recommended that the following language be added to the definition of
spring water: ``After treatment, spring water shall maintain the same
physical properties and chemical composition as the water that does or
would flow naturally to the surface of the earth.''
FDA disagrees with the comment. Spring water may be collected from
the surface by means of a collection box. A properly engineered
collection box captures the water as it surfaces, before it can be
contaminated by surface elements and become surface water. However,
spring water collected under the most sanitary conditions may still
require some treatment.
The definition of ``spring water'' is based on the underground
source of the water. Thus, water meeting the definition of ``spring
water'' in Sec. 165.110(a)(2)(vi) would remain spring water after
treatment, even if the physical properties and chemical composition of
the water are altered from such treatment. For example, ozonation is
commonly used to treat bottled water and may cause some dissolved
minerals, such as manganese, to precipitate. Other treatments, such as
filtering, may also cause changes in the water. As long as the water
meets the definition of ``spring water,'' however, even though it has
been treated, it may be called ``spring water.''
In the case of spring water extracted from a bore hole, the water
must be compared with the water extracted from the natural spring. When
that comparison occurs, either before or after any treatment, may have
a significant impact on whether the water collected from the bore hole
maintains the same physical properties and chemical composition as the
water from the natural orifice. To clarify the intent of the
regulation, FDA is modifying Sec. 165.110(a)(2)(vi) to state that,
before treatment, the water collected from the bore hole must have the
same physical properties and chemical composition and quality as water
from the natural spring.
However under section 201(n) of the Act, if the water has been
treated in such a way that it differs significantly from the source
water, regardless of whether that source water is from a natural spring
or a bore hole, the fact that that alteration has been made is a fact
material in light of representations made and must appear on the label
of the product. The water is no longer unmodified spring water and
differs significantly from the water that was harvested. Therefore, the
fact that the water has been altered significantly must be disclosed in
the statement of identity, so that consumers are aware that the source
water has been modified. If minerals have been added, the statement of
identity must state that fact. If minerals have been removed from the
product, other than those that are removed during normal processing
(e.g., filtration to remove precipitates),
[[Page 57099]]
that fact must be included in the statement of identity of the product
as well (e.g., demineralized) (Sec. 165.110(a)(2)(iv)).
5. Well Water
FDA proposed that the name of bottled water from a hole bored,
drilled, or otherwise constructed in the ground that taps the water of
an aquifer may be ``well water.'' The agency received no comments
requesting modifications to this source definition. Therefore, the
definition for ``well water'' is the same as FDA proposed (58 FR 393),
although it is now codified at Sec. 165.110(a)(2)(viii) as a result of
the additions that FDA has made to Sec. 165.110(a)(2).
6. Other Water Definitions
58. Several comments urged FDA to define ``natural water.''
Comments suggested that ``natural water'' means bottled spring,
artesian, mineral, or well water that is unmodified by mineral addition
or deletion, except that ``natural water'' may be filtered and must be
sanitized with ozone or an equivalent disinfection process and treated
to reduce the concentration of any substance that exceeds an allowable
level established by the agency.
One comment urged FDA to define ``natural water'' as in the IBWA
Model Code. IBWA defines ``natural water'' as spring, mineral,
artesian, or well water that is derived from an underground formation
and that is not derived from a municipal system or public water supply.
Some comments recommended that FDA define ``natural'' for use on
bottled water labels because the term is often used on labels and may
be misused. One comment stated that water to be called and labeled
``natural'' must come from the ground and may be sanitized with ozone
or an equivalent disinfection process. It added that any removal of
excessive substances should not allow that water to be labeled as
``natural.'' Another comment stated that the word ``natural'' should be
used only if the mineral content of the water is not altered during the
production process. Therefore, distilled, purified, or drinking water
products that use reverse osmosis to remove solids, then add back
minerals, could not be described as ``natural.''
One comment suggested that FDA provide for the use of the term
``natural'' in conjunction with ``mineral water'' (i.e., ``natural
mineral water'') as it is allowed in the European standard. The comment
stated that consumers want to be assured that the product that they are
purchasing is from a natural source and has not been blended or
manipulated in any fashion with surface or municipal water sources. The
comment added that the use of the term ``natural'' also implies that,
because of the bacterial purity of the product, chemical disinfection
is not necessary.
Two comments suggested the addition of the word ``natural'' to the
definition of ``spring water'' to fully ensure that the spring water
has the same composition, whether collected through a bore hole or at
the surface, and that it has not been treated except for the addition
of carbon dioxide or the removal of iron and manganese and suspended
solids.
However, two comments stated that the term ``natural water'' should
not be permitted on a label because consumers do not understand what it
means.
The agency considered establishing a definition for ``natural'' in
a proposal on food labeling that it published in the Federal Register
of November 27, 1991 (56 FR 60421 at 60466), because of the widespread
use of the term and the evidence that consumers regard many uses of
this term as noninformative. After considering the comments that it
received in response to the November 27, 1991 proposal, the agency
stated that if the term ``natural'' were adequately defined, the
ambiguity surrounding use of this term that results in misleading
claims could be abated (58 FR 2302 at 2407, January 6, 1993). Because
of resource limitations and other agency priorities, however, FDA did
not undertake rulemaking to define ``natural'' at that time. The agency
stated that, while it regarded the term as meaning that nothing
artificial or synthetic has been included in, or has been added to, a
food that would not normally be expected to be in the food, it would
maintain its policy of not restricting the use of the term except as
provided for in Sec. 101.22 (id.).
A number of States, AFDO, and IBWA have defined ``natural water''
(Refs. 2, 7, 11, 12, 14, and 15). All of the definitions require that
the water be derived from an underground formation (spring, artesian,
or well water) and be unmodified except for limited treatment (e.g.,
filtration and ozonation or equivalent disinfection process). Those
States that have adopted the IBWA model regulation as their State
regulation provide for treatment of ``natural water'' to reduce the
concentration of any substance that exceeds safety standards. The IBWA
model regulation also states that the water ``may be collected and
transported by pumps, pipes, tunnels, trucks, or similar devices.''
The Codex Standard for Natural Mineral Waters and Edible Ices and
Ice Mixes (Codex Standard) (Ref. 1) defines ``natural mineral water''
and ``naturally carbonated natural mineral water.'' These waters are
obtained from underground water-bearing strata either through natural
flow or drilling. Treatments permitted for ``natural mineral water''
under the Codex standard include separation from unstable constituents
by decantation or filtration that is, if necessary, accelerated by
previous aeration.
The agency finds that the IBWA code and State requirements are
basically consistent with FDA's informal policy on ``natural'' because
the product is only minimally processed. However, there are some
surface waters (e.g., water collected from glacier runoff) that may
only require minimal processing to be acceptable bottled waters and,
thus could qualify to be called ``natural.'' Most surface waters and
ground waters under the influence of surface water require additional
processing to ensure that the water is consistent in quality and, thus
could not be labeled as ``natural.'' Therefore, because FDA's informal
policy already encompasses bottled water, the agency concludes that it
is not necessary to establish a regulation that specifically defines
``natural'' for use with bottled water.
59. One comment noted that no consideration was given to the proper
use of the word ``pure.'' It stated that many bottlers misuse this
word.
The agency advises that while there is no specific prohibition
against the use of the term ``pure,'' it has discouraged the use of the
term because it is ambiguous and may be misleading (58 FR 2897 at
2903). For example, ``spring water'' and ``pure spring water'' may be
identical foods, but ``pure,'' as applied to the food, implies that
other identical products are ``impure'' or ``not pure'' if they do not
bear the same term on their label. In addition, the agency notes that
the term ``pure'' may be confused with the term ``purified,'' and
consumers may be misled into believing that bottled water labeled as
``pure'' has been treated to substantially decrease the total dissolved
solids content.
The agency is not convinced that it should use its resources to
define the term ``pure'' at this time but will continue to discourage
its use. In addition, the agency will continue to deal with this issue
on a case-by-case basis.
60. Two comments asked what bottled waters made by using well water
for a source, and then diluting the water with distilled or purified
water to improve hardness and taste, could be called.
Blends of different types of water, such as well water and purified
water,
[[Page 57100]]
may be appropriately labeled as ``bottled water'' or ``drinking
water.'' Truthful statements may also be made on the label to inform
consumers that the product is blended, with the percentage of each type
of water included.
61. Two comments stated that the name ``mountain water'' should not
be permitted on the label because it is misleading to consumers.
The agency is not providing for the use of the term ``mountain
water'' as the name of a bottled water product. The name of the product
is ``bottled water,'' ``drinking water,'' or one or more of the terms
defined in Sec. 165.110(a)(2) as appropriate. However, if the water is
from a mountain source, manufacturers may include a truthful and
nonmisleading statement reflecting that fact.
62. One comment stated that there are bottlers in Canada and Alaska
that bottle ``glacier water'' and asked whether they could continue to
use this term to label their bottled water. It provided a definition
for ``glaciofluvial'' as ``of or relating to or coming from streams
deriving much or all of their water from the melting of a glacier.''
The comment stated that minerals are rarely detectable in this water,
let alone environmental pollutants, and noted that the water requires
little if any filtration. The comments said that the water is passed
through ozonation or ultraviolet light as a precaution for total and
fecal coliform bacterial counts.
FDA notes that the definition that the comment provided is not a
clear definition because, under it, not all of the water need come from
the melting of the glacier, and the percentage of the water actually
coming from the glacier would vary significantly according to the
season of the year. Therefore, FDA is not providing for this term.
FDA notes that manufacturers that bottle this category of water may
state in the labeling that the source of the water is glaciofluvial.
However, the statement of identity for the product is ``bottled water''
or ``drinking water.''
D. Other Label Statements
1. Mineral Content of Mineral Water
The agency tentatively concluded in the January 1993 proposal that
the listing of relative mineral content is useful to consumers to
characterize a given mineral water product. FDA proposed to require
that if the TDS is below 500 ppm, the statement ``low mineral content''
appear on the label. In addition, the agency proposed that if the TDS
of mineral water is more than 1,500 ppm, the statement ``high mineral
content'' must appear on the label. FDA did not propose to define the
term ``light'' or other descriptive terms as they apply to mineral
water because FDA tentatively concluded that the use of only the
statements ``low mineral content'' and ``high mineral content'' would
be less confusing to consumers. FDA proposed that the statement of
mineral content appear on the principal display panel following the
statement of identity in type at least one-half the size of the type
used for the statement of identity but in no case of less than one-
sixteenth of an inch. The agency requested comments concerning the
proposed levels defining high or low mineral content.
63. A number of comments noted that Sec. 165.110(a)(3)(i)
concerning the labeling of a product as ``low mineral content'' or
``high mineral content,'' does not refer solely to ``mineral water''
and objected to this labeling if it were to apply to all bottled
waters. One comment stated that the statement ``low mineral content''
would be misleading on products such as ``artesian water,'' ``spring
water,'' ``well water,'' or ``bottled water'' when they in no way claim
to be mineral water, and this statement would imply a less-than-normal
mineral content. One comment recommended that the regulation state ``if
the TDS content of mineral water is below * * *,'' so that the
regulation only would apply to products labeled as mineral water.
FDA agrees with the comments. The normal mineral content of
artesian water, spring water, well water, bottled water, or any other
bottled water product except for the majority of mineral waters is less
than 500 ppm TDS. In fact, bottled water, except for mineral water,
must comply with the provisions in the quality standard for bottled
water that require that if the product contains more than 500 ppm TDS,
the product be labeled as substandard (Secs. 165.110 (b)(4) and (c)).
In the preamble to the proposal, the agency only discussed labeling a
product as ``low mineral content'' or ``high mineral content'' if the
product was ``mineral water'' (58 FR 393 at 397), although the agency
failed to specifically mention in the regulation that it applied only
to ``mineral water.'' This failure was an oversight. Therefore, the
agency is modifying Sec. 165.110(a)(3)(i) to state that if the total
dissolved solids (TDS) content of mineral water is below 500 ppm, or if
it is greater than 1,500 ppm, the statement ``low mineral content'' or
``high mineral content'', respectively, shall appear on the principal
display panel.
64. A number of comments objected to the labeling of mineral water
as ``low mineral content'' and ``high mineral content'' and requested
that Sec. 165.110(a)(3)(i) be deleted because this labeling would be
confusing to consumers. One comment opposed denoting the ``low'' or
``high'' mineral content of mineral water because flavor is more
affected by specific minerals than by TDS.
FDA disagrees that the label statements concerning low or high
mineral content should be deleted from the regulation. As discussed
previously, the agency is requiring that mineral water contain a
certain amount of minerals because consumers expect that mineral water
contains some minerals. Because the mineral content of mineral water
may vary greatly, and because the high and low ends of the range of
mineral contents may have a significant bearing on the characteristics
of the water, the agency concludes that information about the mineral
level is a material fact, under section 201(n) of the act, in
conjunction with the term ``mineral water.'' The agency's action
establishes three broad categories, but only manufacturers of mineral
waters below 500 ppm TDS or above 1,500 ppm TDS need provide the
additional information on the label.
FDA agrees that the taste of some mineral waters may be affected
more by specific minerals than by total mineral content. Nevertheless,
if a mineral water contains less than 500 ppm TDS, it is important that
consumers be made aware that the product has a low mineral content, and
that it may not have the mineral taste that another mineral water may
have. Many State regulations have required that mineral water contain
more than 500 ppm TDS (Ref. 8), and most mineral water sold in the
United States has complied with this minimum so that it could be sold
in those particular States. Therefore, FDA concludes that the use of
the statement ``low mineral content'' on mineral water containing less
than 500 ppm TDS is appropriate to alert consumers to the fact that the
water may have a lower mineral content than mineral waters that they
have previously purchased.
Additionally, the agency notes that, as discussed in the proposal
to this final rule (58 FR 393 at 397), a mineral content of over 1,500
ppm TDS greatly affects the taste of the water no matter what the
specific minerals may be. Therefore, the agency concludes that because
this information is a material fact, consumers should be informed that
the product contains a high mineral content.
[[Page 57101]]
65. Two comments held that the statement ``low mineral content
water'' on mineral water could be misleading to some consumers if, for
example, they interpret it as saying that the water is low in sodium.
The comment stated that low mineral content mineral waters may be
relatively high in sodium.
FDA disagrees that the statement ``low mineral content'' would be
misleading to consumers. The term ``low'' in this statement is
referring to the overall total dissolved solids content and not to any
specific mineral. However, the agency agrees that some mineral waters
containing between 250 and 500 ppm TDS may contain more than an
insignificant amount of sodium. Under Sec. 101.9(a), nutrition labeling
is required if the product contains more than an insignificant amount
of any nutrient that is required to be included in the declaration of
nutrition information under Sec. 101.9(c). If a product labeled as
``low mineral content'' is not sodium free (i.e., contains 5 or more mg
sodium per serving), nutrition labeling is mandatory, and consumers
will be informed that, although the product is low in mineral content,
it contains more than an insignificant amount of sodium.
66. Four comments asked whether mineral waters with a mineral
content greater than 1,500 ppm could be labeled as ``rich in mineral
salts.''
Another comment stated there may be confusion about the term ``high
mineral content'' because it appears to be substantially similar to
nutrient content claims that are allowed under the Nutrition Labeling
and Education Act of 1990 (the 1990 amendments), and in fact it may be
misinterpreted by many consumers as an indication that the product may
be useful as a mineral supplement.
The agency finds no merit to these comments. In the Federal
Register of January 6, 1993 (58 FR 2302 at 2414), FDA adopted
Sec. 101.54(b)(1), which defines the terms ``high,'' ``rich in,'' and
``excellent source of'' to mean that the food contains 20 percent or
more of the reference daily intake (RDI) or the daily reference value
(DRV) of the nutrient in question per reference amount customarily
consumed. The claim ``high mineral content'' is not subject to
Sec. 101.54 because the term does not describe the nutrient content of
the water. FDA has not defined nutrient content claims for minerals as
a category, only for individual minerals. While FDA has authorized some
nutrient content claims concerning mineral content of foods, such as
``high in three minerals,'' it has not authorized ``high mineral
content.'' Thus, this claim only applies to mineral water.
There is no authorization in FDA's regulations for use of a synonym
for ``high'' in the statement ``high mineral content'' for bottled
water because the statement is not a nutrient content claim but part of
the statement of identity of the product. The term ``rich'' is not
appropriate in this context because it means that a product is
abundantly supplied with something of value. Although the terms
``high,'' ``rich in,'' and ``excellent source of'' have been defined as
synonymous nutrient content claims, not all of these terms are
appropriate when used to describe the mineral content of mineral water
containing more than 1,500 ppm TDS because such water may not be an
``excellent'' or ``rich'' source of minerals of nutritional
significance. Use of the term ``high mineral content,'' however,
provides a quantitative contrast to the term ``low mineral content'' of
mineral water containing less than 500 ppm TDS.
Therefore, FDA concludes that only the declaration ``high mineral
content'' is appropriate for mineral water. Given that the statement is
part of the statement of identity of the product, FDA has not provided
for the use of synonyms. The statement appropriately should be as
simple and as straightforward as possible.
67. One comment stated that 1,500 ppm TDS as the triggering level
for the label statement ``high mineral content'' is an extremely high
level. The comment suggested that the statement ``exceeds the secondary
maximum contaminant level of 500 ppm,'' for mineral water containing
greater than 500 ppm TDS, is a better disclosure and would help to
eliminate consumer confusion over the differences in water quality
standards between bottled water and public tap water.
The agency disagrees with the comment. The term ``mineral water''
has traditionally implied that the water has a higher mineral content
than most water, including public tap water. As discussed in the
proposal (58 FR 393 at 397), all water contains some minerals, unless
it has been demineralized (Ref. 16). Thus, the agency tentatively
concluded that consumers expect that a product identified as ``mineral
water'' would contain at least a minimum level of minerals. This
expectation is reinforced by the fact that some States (Ref. 8) have
only included water that contains more than 500 ppm TDS in their
definition of ``mineral water.''
The label declaration ``high mineral content'' is to inform
consumers that the mineral content is high in comparison to other
mineral waters. As discussed in the proposal (58 FR 393 at 397), a
mineral content of more that 1,500 ppm TDS greatly affects the flavor
of the water. This level is consistent with the European Community
definition of ``mineral water--rich in mineral salts'' (Ref. 17) and
will not hinder international trade. Thus, the comment has not
persuaded the agency that 500 ppm TDS is a more appropriate minimum
level than 1,500 ppm TDS for a product labeled as ``mineral water, high
mineral content.''
Therefore, to ensure that consumers know that the product that they
are purchasing is high in minerals as compared to other mineral waters,
the agency is requiring in Sec. 165.110(a)(3)(i) that the label of
mineral water containing more than 1,500 ppm TDS include the statement
``high mineral content.''
68. Several comments recommended that FDA require that TDS content
appear on the label of all bottled waters because: (1) Consumers will
more easily relate bottled water designations to their specific TDS
ranges, (2) consumers will have a better chance of purchasing a bottled
water corresponding to their tastes if they learn to associate a
particular level of TDS with those tastes, and (3) it renders
unnecessary the ruling that a mineral water with a TDS higher than
1,500 ppm be labeled as ``high mineral content.'' One comment stated
that consumers will rapidly relate TDS content values in the range of
``thousand(s)'' with a ``high mineral taste'' without the need for
arbitrary qualifiers. It added that a TDS labeling requirement works
towards establishing similar standards between Canada and the United
States.
One comment stated that it would be more informative to consumers
to list the TDS in the side panel because concerned consumers want hard
information, not generalities like the relative mineral content
statements that the agency proposed. It stated that there is a gray
area between 250 and 500 ppm TDS in which some waters may taste
distinctive and others may taste undistinctive, like low-TDS spring
water.
FDA disagrees that it should require mandatory declaration of TDS
level. The agency stated in the proposal that many consumers may not
understand the relevance of a specific TDS and, thus, tentatively
concluded that there is no substantive basis on which to require that
this information appear on the label (58 FR 393 at 397). None of the
comments provided any information that showed that consumers would
understand the significance of this information and that would support
a conclusion different than FDA's
[[Page 57102]]
tentative determination. However, the agency will not object if
manufacturers include information concerning the TDS content, or any
information relating to a distinctive taste of a specific product, on
their labels as long as the information is truthful and not misleading.
Because many consumers will not understand the relevance of a
specific TDS (Ref. 16), FDA concludes that the requirement to label
mineral water as ``low mineral content'' or ``high mineral content,''
as appropriate, will be generally more informative to consumers than
TDS labeling. Therefore, the agency concludes that mandatory labeling
of TDS is not necessary, and that there is no substantive basis on
which to require that this information appear on the label.
69. One comment remarked that all bottled water should be labeled
with the percentage of minerals present and the limits allowed. Another
comment encouraged actual content disclosure on bottled water labels,
stating that consumers have a right to know whether any substance
regulated under the Safe Drinking Water Act (the SDWA) is contained in
the bottled water they purchase, even though it would have to be
present at a level below the Maximum Contaminant Level (MCL)
established as being permissible.
The agency disagrees that this additional labeling should be
required. MCL's have not been established for all minerals or other
substances that may be in bottled water. FDA established the standard
of quality for bottled water to require that bottled water meet certain
quality specifications or else be clearly labeled as ``substandard.''
The quality standard for bottled water is based on EPA's regulations
for public drinking water (40 CFR parts 141 and 143), and EPA
establishes its regulations based on health and aesthetic
considerations. Thus, any contaminant present at a level lower than its
maximum allowable level is not considered a safety or quality concern.
Given this fact, there is no basis to require the information that
the comments requested. The information would not be a material fact,
and thus there would be no basis to claim that the product is
misbranded if the information is not disclosed. The presence of these
substances in bottled water at levels meeting the quality standard is
inconsequential. The appearance of this information on the label may be
confusing and may imply that the substance is present in excessive
amounts when it is not. Therefore, the agency concludes that the
requested additional labeling is not warranted.
70. One comment requested that FDA add the following language to
Sec. 165.110(a)(3)(i): ``Mineral water products falling between the TDS
values of 500 to 1,500 mg/L do not have to add additional terms.''
The agency notes that mineral water containing more than 500 ppm
TDS and less than 1,500 ppm TDS need not bear labeling on relative
mineral content. Although a specific statement to this effect is not
necessary in the regulation, FDA is modifying Sec. 165.110(a)(3)(i) to
state that if the TDS of mineral water is between 500 and 1,500 ppm, no
additional statement need appear. The agency concludes that this
modification will clarify the regulation.
71. One comment suggested that the producers of identified, sole-
source bottled water products (e.g., artesian or mineral waters) that
desire to market their products based on the naturally occurring
mineral contents be allowed to label their products: ``Water with (or
containing) naturally occurring minerals,'' provided that the product
labeling clearly identifies the water's sole source and also identifies
the naturally occurring minerals. It stated that such mineral
identification in the labeling of natural, identified sole-source water
should not require additional nutrition information.
The agency disagrees with the comment. All water, unless it has
been treated to remove minerals or has had minerals added, contains
naturally occurring minerals, regardless of whether it comes from an
identified single source. A statement such as ``water with naturally
occurring minerals'' has the potential to be misleading to consumers
because it implies that the products of competitors may contain added
minerals or have had minerals removed, when, in fact, they have not.
However, manufacturers may use the term ``natural'' on their bottled
water labels if they follow FDA's informal policy as discussed
previously (see comment 58) of this document.
The agency is not defining the statement ``water with naturally
occurring minerals'' for bottled water labels at this time because it
has no basis to conclude that use of the statement would not be
misleading, or that it would be useful to consumers. The comment did
not provide sufficient information on which to base a regulation.
2. Water From a Municipal Supply
The agency proposed to require that the phrase ``from a municipal
source'' appear on the principal display panel or panels as a part of
the name of the food if the water is obtained from a municipal water
supply, except if the water has been treated to meet the definitions of
distilled water or purified water (58 FR 393 at 399). FDA also proposed
to require that the statement appear on the principal display panel
following the statement of identity in type at least one-half the size
of the type in which the statement of identity appears but in no case
less than one- sixteenth of an inch. The agency also proposed to
require that the statement immediately and conspicuously precede or
follow the name of the food without intervening written, printed, or
graphic matter, other than statements required by proposed
Sec. 165.110(c).
72. Two comments suggested that FDA use the term ``public water
supply'' as defined by EPA rather than use the term ``municipal
supply.'' The comments noted that the use of the term ``public water
supply'' would avoid confusion, as FDA would be using a term that is
already defined and well understood. One comment stated that questions
could arise about the definition of a ``municipal supply,'' such as how
many people would a supply be required to serve to meet the definition
of a ``municipal supply.'' Another comment stated that the term
``public water system'' is a more appropriate term because it would
include the numerous water systems that are independent water purveyors
not affiliated with specific municipalities.
The agency disagrees that the statement ``from a municipal source''
should be replaced with ``from a public water supply'' or ``from a
public water system'' in Sec. 165.110(a)(3)(ii). EPA defines a ``public
water system'' as a system that provides piped water for human
consumption and that: (1) Has at least 15 service connections, or (2)
regularly serves at least 25 persons at least 60 days per year (40 CFR
141.2). Public water systems are split into two categories: Community
and noncommunity water systems. Community water systems are systems
that regularly serve 25 or more year-round residents (or have at least
15 service connections used by year-round residents) (40 CFR 141.2).
Many factories, restaurants, schools, parks, and rest areas also
operate their own supply of drinking water. However, these systems do
not have the required residential community and are, thus, considered
noncommunity systems.
There are two types of noncommunity water systems: Transient
noncommunity or nontransient noncommunity (40 CFR 141.2).
[[Page 57103]]
Transient noncommunity systems serve travelers and other transients at
locations such as highway rest stops, small restaurants, and public
parks. The system serves at least 25 people a day for at least 60 days
per year but typically not the same 25 people each day (40 CFR 141.2).
On the other hand, nontransient noncommunity water systems do serve the
same 25 persons for at least 6 months a year but not on a year-round
residential basis (40 CFR 141.2). Schools and workplaces that have
their own water supply and serve at least 25 of the same persons each
day are examples of these systems.
The agency stated in the proposal (58 FR 393 at 399) that
information about the actual source of a bottled water product is a
material fact in light of either the explicit (e.g., use of terms such
as ``spring'' or ``well'') or implied (the presentation of the product
in the bottle) representation made by a bottled water product that the
product is not tap water. Information about the source of the water is
necessary to ensure that consumers do not incorrectly assume that
because water is sold in a bottle it is not tap water.
According to 40 CFR 142.2, a ``municipality'' means a city, town,
or other public body created by, or pursuant to, State law. Municipal
water sources are systems that serve municipalities. Thus the term
``municipal source'' may be too narrow to encompass all types of tap
water sources. Independent water purveyors and other community systems
may operate similarly to municipal water sources, rely on the same
types of water (e.g., surface water), use the same type of treatments
of the water, and supply the water that flows from a tap. They may
differ from a municipal source only in that they are not affiliated
with a municipality.
Thus, FDA agrees that water from water systems that are independent
water purveyors, but that are not affiliated with specific
municipalities, should bear labeling that makes clear its source.
Clearly, what would be considered a municipal source would be
encompassed by the definition of a community water system because a
source supplying an incorporated city or town would regularly serve 25
or more people on a year-round basis (or have the minimum 15 year-round
service connections). The term ``community water system'' would
encompass the independent water purveyors that the term ``municipal
source'' would not.
Noncommunity water systems by definition would not serve a
municipality. FDA notes that some bottled water firms may meet the
definition of a nontransient noncommunity system if they employ at
least 25 persons and use the source water as the workplace water
supply. The intent of the labeling requirement was not to include these
bottled water manufacturers. Their water is considered a public water
system only because they choose to use their own water source and not
pipe water in from another source for their workplace water supply.
Therefore, the agency concludes that bottled water from a community
water system, as defined by EPA (40 CFR 141.2), must bear source
labeling. FDA finds that including all community water system sources
in Sec. 165.110(a)(3)(ii) is the logical outgrowth of the January 5,
1993, proposal because the intent of the proposal, as explained above,
was to cover all tap water. Thus, FDA is revising
Sec. 165.110(a)(3)(ii) to apply to bottled water coming from a
community water system as defined in 40 CFR 141.2, rather than from a
municipal source. Alternatively, manufacturers may label their product
as ``from a municipal source'' if appropriate. (Moreover, as explained
in comment 96 of this document, there may be some instances in which
``from a public water supply'' or ``from a public water system'' is
appropriate.)
73. One comment disagreed with the provision that would exempt
purified water from having to be labeled as from a municipal supply. It
stated that the process does not change the source.
Although the agency acknowledges that purification does not change
the source, FDA concludes that the exception for purified water is
appropriate. As FDA stated in the proposal (58 FR 393 at 399),
consumers purchase purified water because of its treatment and
resultant purity rather than because of its source. In addition,
because purified water and distilled water must meet the compositional
requirements of the USP monograph for purified water, there are no
significant compositional differences among purified and distilled
waters, regardless of the source of the water. Source information for
purified waters is not a material fact because the water may be
significantly different in composition than other water from that
particular source. Thus, the absence of source information for purified
water is not misleading under section 403(a) of the act. The comment
did not present any information other than the basic argument
summarized above. Thus, FDA is not making any changes in response to
this comment. However, manufacturers may optionally include source
information on the label of purified water.
74. Several comments stated that proposed Sec. 165.110(a)(3)(ii)
implies that if bottled water from a municipal source has been treated
to meet the definition of ``purified'' or ``distilled water,'' it may
be exempt from the labeling declaration of ``from a municipal source,''
whether or not the product is labeled as ``purified water'' or
``distilled water.'' The comments stated that the circumstances in
which the municipal source of the water need not be disclosed should be
limited, as the agency apparently intended, to when the water is
labeled as ``purified'' or ``distilled.'' To effect this limitation,
the comments suggested that the agency add the words ``and is labeled
as such'' to the regulation.
The agency agrees with the comments. In the preamble to the
proposal, the agency stated that the exemption would apply only to
purified water or distilled water that was labeled as such (58 FR 393
at 399). However, FDA failed to include the statement ``and is labeled
as such'' in the regulation. Therefore, FDA is modifying
Sec. 165.110(a)(3)(ii) to include this requirement.
In addition, because FDA has included the alternative terms
``deionized water,'' ``demineralized water,'' ``purified drinking
water,'' and ``reverse osmosis water'' in the definition of purified
water, the agency is modifying Sec. 165.110(a)(3)(ii) to include all of
the terms that may be used under Sec. 165.110(a)(2)(iv) in the
exemption.
75. One comment requested that, if the source of bottled water
labeled as ``sterilized water'' is a municipal source, the product be
exempt from the labeling requirements in Sec. 165.110(a)(3)(ii).
The agency agrees that use of the terms ``sterile'' or
``sterilized'' on the label of bottled water should exempt it from the
requirements of Sec. 165.110(a)(3)(ii). Sterile water has undergone a
treatment to meet strict microbiological standards. Purified water is
exempt from the requirements of Sec. 165.110(a)(3)(ii) in part because
the process of purification removes many substances that are typical of
the source water, and also because there are no significant differences
between purified waters even though the source waters may be very
different. Consumers may purchase purified water and sterile water
because of the specific treatment and not the source of the water. In
addition, because sterile water must meet the microbiological
requirements of the USP definition for ``sterile,'' there are no
significant microbiological
[[Page 57104]]
differences among sterile waters, regardless of the source of the
water. Source information for sterile waters is not a material fact
because the water may be significantly different in microbiological
content than water from that particular source. Thus, the absence of
source information for sterile water is not misleading under section
403(a) of the act.
Therefore, the agency is modifying Sec. 165.110(a)(3)(ii) to exempt
sterile water and sterilized water that is from a community water
system from the source labeling requirement.
76. One comment stated that FDA overlooked source labeling of
partially purified water from a municipal source that is processed to
remove some chemicals but does not meet the requirements of purified
water.
FDA disagrees with the comment and affirms that water from a
community water system that is partially purified (i.e., it does not
meet the definition of purified water) does not qualify for an
exemption from the requirements of Sec. 165.110(a)(3)(ii). As discussed
above under comment 74 of this document, there are no significant
compositional differences between purified and distilled waters,
regardless of the source of the water. Partially purified water,
however, effectively continues to resemble the source water. Because
partially purified water does not qualify for the exemption, it is
covered by Sec. 165.110(a)(3)(ii). Therefore, if the water is partially
processed, and is from a community water source, the label must declare
the latter fact.
77. One comment stated that it would be misleading if a country
setting is shown on the label, including lakes or ponds, and the
product is drinking water processed from municipal supplies via reverse
osmosis systems.
FDA agrees that the use of certain graphics on a label of bottled
water may be misleading to consumers if the source of the water is
different than the source depicted or implied. For example, a country
setting on a label may mislead consumers into believing that the
product is spring water when it is not. Section 403(a) of the act
specifically states that a food shall be deemed to be misbranded if its
labeling is false or misleading in any particular. If a product is from
a community water system, the label must clearly disclose this fact
except as provided in Sec. 165.110(a)(3)(ii).
78. Several comments stated that FDA has not provided, except in
Sec. 129.80(a), for the long-established industry practice of adding
minerals to adjust the taste of water that has been previously treated
to meet the definition of ``distilled'' or ``purified water.'' One
comment stated that water that is purified to meet the definition for
``purified water,'' and subsequently has minerals added back to it,
should be exempt from the source labeling requirement in
Sec. 165.110(a)(3)(ii) because it has a totally different composition
than other water from the municipal source. It stated that the labeling
could indicate that the water was purified or distilled, and that
minerals had been added for flavor. Another comment stated that this
approach would allow for flexibility in labeling while providing
adequate information for the consumer.
FDA advises that water from a community water system that has been
treated to meet the definition of ``purified water'' in
Sec. 165.110(a)(2)(iv), and is labeled as ``purified water'' or one of
its alternative names, is exempt from the labeling requirements of
Sec. 165.110(a)(3)(ii). Water with minerals added for taste is
considered a multi-component food, and the labeling ``from a municipal
source'' describes only the water ingredient. Thus, if minerals are
added to purified water for taste, and the label states that the
product is ``purified water (or any of its alternative names) with
minerals added for taste,'' the product is exempt from
Sec. 165.110(a)(3)(ii) because the water ingredient meets the criteria
for the exemption.
79. Some comments agreed with the requirement in
Sec. 165.110(a)(3)(ii) but stated that the name of the source, be it a
municipal source, water authority, or any other public water system,
should be specifically included on the label so that the consumer may
obtain water quality test results, such as those maintained by the
public water system or the relevant regulatory agency. One comment
stated that consumers may then compare water quality results of the
bottler with those of the public water system selling the water to the
bottler, and consumers could contact the municipal source and ascertain
whether a bottler is using a municipal source that adds fluoride to its
finished water.
Other comments requested that all bottlers of water list on the
label the source of the product contained in the bottle. Comments asked
that, for full disclosure, bottled water labels include the name of
manufacturer, address of source, and well number or spring's legal
name, so that consumers will know specifically from where the water
comes. One comment noted that many States require the geographic source
identity. Another comment added that many companies are misrepresenting
their products to the consumer by vague labeling.
FDA does not object to the optional label declaration of more
specific information concerning the water source because such
information may be useful to some consumers. However, the agency does
not agree that it should require specific water source labeling, or
that the lack of such labeling means that the label is misleading and
vague.
Under section 201(n) of the act, the agency must consider whether
the information is a material fact whose nondisclosure will render the
labeling misleading. Under this standard, it is difficult to see why
the name of the specific source, be it a public water supply, spring,
or well, would be a material fact. The agency requires that the product
water supply for each bottled water plant be from a source that is
inspected and approved by the government agency having jurisdiction
(Sec. 129.3(a)). The product water supply must be properly located,
protected, and operated, and must be easily accessible, adequate, and
of a safe, sanitary quality that is in conformance at all times with
the applicable laws and regulations of the government agency having
jurisdiction (Sec. 129.35(a)(1)). Thus, the specific name of the source
is not material to ensure the safety of the product.
In addition, the water must meet the requirements of the quality
standard in Sec. 165.110(b) or be labeled as substandard. Thus, the
identity of the specific source is not material to ensure the quality
of the product.
Finally, in this final rule FDA is providing for the use of
alternative names that generally describe the source of the water
(e.g., artesian, spring, and well). Thus, consumers can have confidence
that bottled water labeled as being from a certain type of water source
is from a source meeting an appropriate definition.
Therefore, the agency concludes that the absence of information
concerning the exact water source (e.g., specific municipal source, the
well number, spring's legal name, address of the source) is not a
material omission that would render the labeling misleading because
bottled water must meet FDA's requirements which provide the consumer
with assurances as to the safety, quality, and type of source. While
the agency recognizes that some States require the geographic source
identity, FDA simply is not persuaded that the additional information
is a material fact that must be disclosed.
The brand name and the name of the manufacturer distinguish bottled
waters as much as specific source labeling
[[Page 57105]]
would. According to Sec. 101.5(a), the label of a food in packaged form
must specify conspicuously the name and place of business of the
manufacturer, packer, or distributor. This labeling requirement
provides consumers with the necessary information to contact the firm
and obtain information (e.g., the name and location of the source, the
well number, or the spring's legal name) that is not provided on the
label if they are interested. Therefore, FDA concludes that there is no
basis on which to require that information concerning the specific
source of bottled water appear on the label.
3. Water for Infant Use
The agency proposed to require notice on the principal display
panel of bottled water products that are promoted for infant use that
such products are not sterile (if such is in fact the case), and that
they should be used as directed by a physician or by infant formula
preparation instructions (58 FR 393 at 400).
80. One comment stated that Sec. 165.110(a)(3)(iii) should read:
``When the label or labeling characterizes the bottled water in any
manner * * * as for feeding infants, and the product is not
commercially sterile, within the meaning of the term at 21 CFR
113.3(e), the principal display panel shall bear conspicuously the
phrase * * *.'' The comment stated that a qualification of the phrase
``not sterile'' to ``not commercially sterile'' would clarify that, by
use of the term ``sterile,'' the agency does not intend to require that
bottled water for infant food use meet the requirements of the USP
monographs for sterile waters which are compendial pharmaceutical
articles in themselves. It stated that there is no safety concern that
necessitates that bottled water for infant use meet a different
standard than the standard applicable to hermetically sealed low-acid
foods, and none has been articulated by FDA in the proposal.
The agency agrees with the comment. As discussed previously, unless
the label or labeling of a product that is labeled for use in feeding
infants implies that the product meets USP requirements, FDA will not
require that the product meet those requirements for sterility because
commercial sterility is adequate. Canned infant formula is processed to
be commercially sterile, as defined in Sec. 113.3(e), and the agency
sees no reason to subject bottled water for infants to stricter
requirements. Therefore, the agency is modifying
Sec. 165.110(a)(3)(iii) to state that its provisions apply when the
product is not commercially sterile under Sec. 113.3(e)(3)(i).
81. A number of comments opposed the use of the phrase ``not
sterile, use as directed by physician or by labeling directions for use
of infant formula'' in Sec. 165.110(a)(3)(iii). The comments stated
that infants, and even adults, do not require sterile foods but need
foods that are free of pathogens, and that many health care
professionals do not recommend sterilizing infant formula. Some
comments submitted scientific publications to support their position
that infants do not need sterile foods. They pointed out that infant
medicines, oral preparations (vitamins), and breast milk are not
sterile.
Comments noted that it is difficult for parents to achieve and
maintain sterility in infant preparations and stated that there is no
difference between infant formulas prepared using a clean method and
formulas prepared with sterile water. They stated that boiling bottled
water that is not sterile may not be preferable to using water as it
comes from the bottle because potentially harmful trace elements from
the container used to boil the water may be concentrated during
boiling. The comments maintained that, in some cases (e.g., areas not
served by municipal supplies), bottled water may be a more reliable and
superior source of water for infant use than other sources of water.
Some comments held that the requirement for the use of the phrase
``not sterile'' on infant formula or bottled water labeling is
outdated, inappropriate, and may be unnecessarily alarming to
consumers. They asserted that the phrase may have the unintended but
harmful effect of giving a false sense of security to parents that
would cause them, and perhaps cause the preparer of the infant formula,
to ignore several important sources of bacterial risk.
Comments stated that the recommendations calling for sterilization
were made in the 1940's and 1950's, before the widespread practice of
chlorination of municipal water supplies, and that bottled water
products being marketed today go through a rigorous quality control
program to eliminate pathogens. They maintained that there already are
adequate industry standards in place, and that the phrase ``not
sterile'' is not necessary.
Some comments pointed out that all aqueous systems contain a
normal, nonpathogenic microbial content, and that the absence of such a
normal microbial content could in itself be indicative of the presence
of a microbial antimetabolite in the water. Comments stated that a
requirement for the label statement ``not sterile'' lacks technical
merit and is contrary to FDA's position of not imposing plate count
limitations on all food products. They stated that FDA provided no
scientific rationale, hospital survey data, epidemiological health
data, physician-use surveys, bottled water surveys, or any other
reasonable, objective information to support this requirement. The
comments held that sterilization does not provide a level of safety
assurance equal to the assurance provided by the conjunction of
protecting the aquifer from all risks of contamination and compliance
with current good manufacturing practices (CGMP's), as demonstrated by
the absence of microorganisms that are indicators of contamination
(fecal bacteria).
Other comments stated that requiring a statement that the water is
not sterile would serve only to eliminate certain products from the
bottled water market. They held that it would be grossly misleading,
unjustified, and discriminatory to the infant water industry.
Comments stated that the labeling recommended, but not required, by
FDA for infant formula is to direct parents to consult with their
physicians before using the product. The comments stated that this
labeling of infant formula is to ensure that the parents are using the
proper type and amount of formula for their babies, not because there
was or should be concern about the water source used to mix the
product. These comments recommended that FDA drop the requirement in
Sec. 165.110(a)(3)(iii) entirely because such labeling gives medical
advice to parents. As an alternative, comments suggested that labeling
could state that ``parents should consult their physician for infant
use.''
Conversely, several comments supported the proposal because: (1)
Infants are a high-risk group in terms of susceptibility to infections,
(2) consumers will interpret a label ``water for infant use'' as not
requiring any preparation before use in infant formulas, and (3) the
disclosure required for bottled water marketed for use with infants or
children is consistent with the objectives of FDA in promulgating these
regulations. One comment added that labeling that can mislead a
consumer to use nonsterile water in the belief that it is sterile may
cause needless illness and possibly deaths.
One comment stated that bottled water intended for the general
population is used for a significant proportion of infants. It
suggested a side
[[Page 57106]]
panel statement on all bottled water products such as: ``If using to
prepare infant formula, follow the mixing instructions on the infant
formula label.'' Another comment suggested that each label reference to
use for infant formula preparation be accompanied by a statement
referring the consumer to the side panel usage instructions.
However, another comment that supported the intent of the
disclosure statement disagreed with the proposed labeling requirement
for infant water. It stated that the proposed requirement in
Sec. 165.110(a)(3)(iii) is a backward approach to public health
protection for infants. The comment stated that bottled water promoted
for infant use should be required to meet strict sterility
requirements.
FDA has considered these comments and, based on its consideration,
concludes that labeling is necessary to inform consumers that bottled
water labeled for infant use may not be sterile.
The agency generally agrees with the conclusions of the scientific
publications that the commenters submitted. Although the conclusions of
the articles demonstrated that infants generally do not need to consume
a sterile product, one publication noted that ``it is safer to feed an
infant an almost sterile formula, than to feed him a formula with an
unknown amount of contamination'' (Ref. 18). Use of appropriate
ingredients and procedures in the preparation of infant formula is key
in providing a suitable product for infant consumption.
One study, concerning the inoculation of the digestive tracts of
axenic mice with the autochthonous bacteria of mineral water, was
conducted on 6-week-old mice and found that the autochthonous bacteria
present in the mineral water from Vittel ``Grande Source'' were not
able to establish themselves (i.e., to multiply and subsist in a great
number) in the digestive tracts of axenic mice (Ref. 19). However, FDA
questions whether these results apply to human infants because 6-week-
old mice are past an infant stage. In addition, only one source of
water was used in the study, and the results cannot be extrapolated to
water from other sources.
The agency agrees with the comments that stated that nursing
infants do not consume a sterile product, and that infants do not
necessarily need to consume sterile products. However, although the
heterotrophic bacteria present in water may not be harmful to the
general population, high levels of some microorganisms, particularly
opportunistic pathogens, may cause illness in some infants (Ref. 20).
Parents need to be informed that bottled water labeled for infant use
is not sterile because, without this statement, they may be led to
believe that water labeled for infant use is sterile, and that its
sterility is the characteristic that makes it appropriate for infant
use. Thus, the agency concludes that bottled water intended for infant
use should be at least commercially sterile or be labeled to inform
consumers that it is not.
There are essentially two situations in which an infant may consume
infant water: (1) When it is used to reconstitute powdered infant
formula or dilute concentrated liquid formula; and (2) when it is not
used as an ingredient of the infant formula but is otherwise fed to
infants, especially when used directly for feeding infants. If infant
water was used only in the first situation, the labeling statement on
infant water to ``use as directed on the infant formula labeling''
would be sufficient (and indeed, the additional statement ``use as
directed by a physician'' would be redundant, since this statement is
also required on the formula label). Concerns of sterility are
adequately addressed on the infant formula label because under
Sec. 107.20 (21 CFR 107.20), the product label must bear instructions
for sterilization of water, bottles, and nipples when necessary for
preparing infant formula for use. However, the second situation does
not involve other appropriate labeling information. The second
situation represents circumstances in which it would be appropriate to
seek physician oversight, not only because of a potential concern about
sterility, but also because of the concern about excessive feeding of
water (and risk of hyponatremia) to infants.
FDA agrees that once a package has been opened, it is subject to
contamination. The process of preparing infant formula may also
introduce other sources of contamination. The contamination of these
foods from environmental sources and during preparation may not be
harmful to most infants. However, parents must be aware of the fact
that bottled infant water is not sterile, so that they may take special
precautions if needed. Parents may be purchasing bottled infant water
rather than using other sources of water including tap water and other
types of bottled water specifically because they assume that the infant
water is sterile.
The agency is not advocating that parents boil bottled water that
is not sterile and that is intended for infants. However, parents need
to use infant water as directed by their physicians or by the labeling
for infant formula. The agency stated in the final rule concerning
labeling requirements for infant formula that ``potable,'' ``sterile,''
or ``pure drinking water'' must be used in preparing infant formula (50
FR 1833 at 1836, January 14, 1985). As stated previously in the
response to this comment, under Sec. 107.20(a)(3), infant formula
labels must bear directions for sterilization of water, bottles, and
nipples when necessary for preparing infant formula for use. In
addition, Sec. 107.20(b) requires that a pictogram appear on the label
depicting the major steps for preparation of that infant formula. One
of the steps in the example provided in the regulation includes an
accompanying statement that sterilization is recommended, and that the
infant's physician will decide if it is not required.
Thus, while it is true that recommendations for sterilization of
water for infant use were made before the widespread practice of
chlorination of municipal water supplies, FDA's regulations provide
that sterilization should occur unless the physician decides otherwise.
Parents need to consult with the infant's physician to determine
whether sterilization is not necessary. The labeling requirement on
bottled water is necessary to inform parents that the water is not
sterile. Thus, if the physician says that sterilization of the infant's
water is necessary, the parents will know that it is necessary to take
appropriate steps to provide the infant with sterile water.
FDA agrees that bottled water ordinarily contains a normal
microbial content unless treated. As some comments pointed out, the
reason for the absence of microorganisms in bottled water may be from
the presence of an antimetabolite (i.e., an antimicrobial agent) in the
water. The bottled water standards allow for the optional addition of
safe and suitable antimicrobial agents, and the lack of microorganisms
may be the result of the addition or use of these agents. As defined in
Sec. 130.3(d), ``safe and suitable'' means that the ingredient performs
an appropriate function in the food, is used at a level no higher than
necessary to achieve its intended purpose, and is used in conformity
with established regulations. Bottled water containing a substance,
such as an antimetabolite, at a level considered injurious to health is
deemed to be adulterated under section 402(a) of the act.
FDA disagrees that all bottled water labels need a side panel
statement concerning infant use. Under section 201(n) of the act, in
conjunction with section 701(a) of the act, the agency is authorized to
require labeling if the
[[Page 57107]]
information is a material fact with respect to consequences that may
result from the usual and customary use of the article. Because most
bottled water is not consumed by infants, however, and thus, infant use
is not the usual or customary use of bottled water, in the absence of
other relevant statements in the labeling, only a mandatory statement
on bottled water for infant use is necessary to disclose a material
fact under section 201(n) of the act. Therefore, the agency concludes
that the comment has not provided sufficient grounds to require that
all bottled water bear this statement.
In regard to the comments stating that the labeling requirement is
misleading, unjustified, and discriminatory to the infant water
industry, the agency has found that this information is a material fact
on infant water under section 201(n) of the act because the product is
targeted for an infant subpopulation that has unique needs.
Manufacturers are labeling their products with a special claim, and
thus the agency is establishing a special requirement, the disclosure
of a fact that is material in light of the claim, for the use of this
claim.
Finally, the agency does not agree that all bottled water intended
for use by infants should be sterile. As already discussed under this
comment, infants do not always require sterile products. Thus, it is
not necessary to require that bottled infant water be sterile.
Therefore, for the reasons discussed above, FDA concludes that the
label statement, ``Not sterile. Use as directed by physician or by
labeling directions for use of infant formula'' is appropriate for
bottled water that is labeled for use in feeding infants if the product
is not commercially sterile.
82. Three comments stated that the agency should consider limiting
the sodium levels of infant waters to levels lower than those
authorized for adults. They suggested limiting sodium levels to a
maximum of 25 mg/L.
FDA disagrees with these comments. Sodium is an important nutrient
for infants, and the agency has determined that it would not be prudent
to take a regulatory approach that could cause bottlers to eliminate
the sodium from their infant water products. However, FDA acknowledges
that there is concern that, if sodium is consumed at high levels,
infants may develop a taste for it that can have consequences later in
life. The agency's infant formula regulations, in Sec. 107.100(a) (21
CFR 107.100(a)), specify that for each 100 kilocalories of formula in
the form prepared for consumption as directed on the container, the
formula contain at least 20 mg, and not more than 60 mg, of sodium.
Bottled water is generally not a significant source of sodium. Data
on the sodium content of the U.S. water supplies were reviewed and
discussed in the April 18, 1984, final rule on the declaration of
sodium content (49 FR 15510 at 15524). The data revealed that 50
percent of the water sources contain less than 3.0 mg sodium per 6
fluid ounces (oz), and that 95 percent contain less than 17.7 mg sodium
per 6 fluid oz. Higher sodium levels, up to 52.9 mg per 6 fluid oz,
occur in only 5 percent of the water sources.
Any bottled water, including bottled infant water, containing more
than an insignificant amount of sodium (5 mg or more per 240 mL
serving) must bear nutrition labeling that lists the number of mg of
sodium per serving. The comment's recommended maximum level of 25 mg/L
sodium is equivalent to 6 mg per 240 mL serving. Thus, any bottled
water at or above the comment's recommended level will, in fact, be
required to bear nutrition labeling.
Therefore, the agency concludes that no maximum level for sodium is
warranted for bottled water labeled for infants because sodium is an
important nutrient for infants, and bottled water generally does not
contain more than an insignificant amount of sodium. Parents concerned
about the amount of sodium in bottled water labeled for infant use will
be alerted to the presence of more than an insignificant amount of
sodium through nutrition labeling.
83. Three comments stated that the agency should consider limiting
the nitrate levels of infant waters to levels lower than those
authorized for adults. They suggested limiting nitrate levels to a
maximum of 15 mg/L when expressed as nitrate (NO3-) (3.4 mg/L when
expressed as nitrogen (N)). The comments stated that infants are
particularly at risk from ingestion of large amounts of nitrates which,
at high doses, can result in cases of methemoglobinemia (blue baby
syndrome).
In the Federal Register of December 1, 1994 (59 FR 61529)
(hereinafter referred to as the December 1994 final rule), FDA
established maximum levels of 10.0 ppm for nitrate (as N), 1 mg/L for
nitrite (as N), and 10 mg/L (as N) for total nitrate and nitrite in
bottled water (Sec. 165.110(b)(4)(iii)(A)). Bottled water exceeding
these levels must be labeled as substandard under Sec. 165.110(c)(3).
FDA's maximum levels are based on maximum contaminant level goals
(MCLG's) established by EPA in the Federal Register of January 30, 1991
(56 FR 3526). EPA based the MCLG's on the toxicity of nitrate in humans
from the reduction of nitrate to nitrite in the human body. By reacting
with hemoglobin, nitrite forms methemoglobin, which will not transport
oxygen to the tissues and thus can lead to asphyxia (i.e., blue
babies). If sufficiently severe, asphyxia can lead to death. Concern
for adverse effects of nitrate and nitrite are primarily for infants
and other special populations.
Therefore, because the toxicity of nitrate and nitrite in infants
and other special populations was considered in establishing EPA's
MCLG's, the agency concludes that there is no basis to establish a
separate level for bottled water intended for infant use.
4. Method of Preparation of Purified Water
FDA did not propose to require that the method of preparation of
purified water be stated on the label, although it stated that a
manufacturer may include this information on the label if it desires.
FDA requested comments from interested persons on the need to include
this information on the label.
84. One comment stated that the specific purification process
should be identified on the label because the public has a right to
know what specific treatment the water receives.
FDA disagrees with the comment. Although the information may be
useful for some consumers, the agency tentatively concluded in the
proposal that there was no substantive basis on which to require that
this information appear on the label. Under section 201(n) of the Act,
the agency must determine, among other factors, whether the information
is a material fact with respect to consequences that may result from
use of the article, or in light of other representations made in the
labeling, to require that information appear on the label. As discussed
previously, purified water is defined compositionally, and there are no
significant compositional differences among purified waters prepared
through the different methods. Therefore, FDA finds that the comment
has not provided an appropriate basis to justify a requirement that the
specific purification process appear on the label, and it is not
requiring that the method of preparation be stated on the label of
purified water. However, a manufacturer may include this information on
the label if it so desires.
5. Other Labeling
85. One comment asked that FDA reconsider IBWA's requested
provision that any bottler whose corporate name, brand name, or
trademark contains the
[[Page 57108]]
words ``spring,'' ``well,'' ``artesian,'' ``mineral,'' or any other
derivation should be required to label each bottle with the type of
bottled product in typeface at least equal to the size of the typeface
of the corporate name, brand name, or trademark if the type of bottled
water differs from that implied in the corporate name, brand name, or
trademark. It stated that this requirement may eliminate some of the
misconceptions consumers have about bottled water products on which the
term ``spring water'' appears as part of the corporate name.
Another comment expressed concern about labels that use trade names
or registered and unregistered trademarks on water that imply a
geographic origin that is different from the actual source of the
water.
The agency agrees that the use of certain corporate names, brand
names, and trademarks may be misleading to consumers if the source of
the water is different from the source stated or implied. Section
403(a) of the Act specifically states that a food shall be deemed to be
misbranded if its labeling is false or misleading in any particular.
Thus, the use of terms or vignettes that state or imply that the source
of the water is different than the actual source would misbrand the
food. In addition, section 403(f) of the Act states that a food is
misbranded if any word, statement, or other information required by or
under authority of the Act to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared with
other words, statements, designs, or devices in the labeling) and in
such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use.
Thus, if required labeling describing the water is not appropriately
conspicuous in relation to other label representations, the product is
misbranded. Therefore, the agency concludes that it already has the
authority to charge misbranding under the Act in the situations
discussed by the comments, and that a specific regulation is not
necessary. With the establishment of the standard of identity in
Sec. 165.110(a), FDA now has particular definitions of bottled water
sources that will assist the agency in enforcing these misbranding
provisions of the Act.
86. One comment stated that water can support the growth of
bacteria, and that opening the bottle and pouring out the water exposes
the remaining water to air and can constitute an ``inoculation'' with
environmental bacteria. It stated that few consumers are aware that
water is a suitable growth medium for bacteria, and that FDA may
consider the advisability of a storage statement, such as ``refrigerate
after opening,'' in the usage instructions for bottled water.
The agency does not agree that such labeling is necessary, although
it would not object to manufacturers voluntarily including a statement
such as ``refrigerate after opening'' on the label. The agency has
established a microbiological quality standard in Sec. 165.110(b)(2).
In the Federal Register of October 6, 1993 (58 FR 52042), FDA proposed
to amend the microbiological quality provision to require that bottled
water be free of coliform bacteria. The agency expects to issue a final
rule in that proceeding soon. Also in the October 6, 1993 proposal, FDA
requested comments on other matters concerning the microbiological
quality of bottled water. The agency will address these issues as
appropriate.
FDA acknowledges that some bacteria can grow in bottled water, and
that bottled water, unless treated in some manner, is not sterile.
Innocuous bacteria are generally already present before the consumer's
first use. Additional bacteria may enter a bottle of water with
exposure to the air. However, the growth of bacteria is limited in
bottled water because it is not a good source of nutrients for most
microorganisms.
Therefore, the agency is not convinced that a statement such as
``refrigerate after opening'' is necessary on bottled water because
water is not a good growth medium for microorganisms, and because the
agency has already addressed microbiological standards in its quality
standard.
III. Standard of Quality
FDA proposed to move the definition for bottled water from
Sec. 103.35(a)(1) to Sec. 165.110(a)(1) and the standard of quality for
bottled water from Sec. 103.35 to Sec. 165.110. The agency also
proposed to include existing definitions for ``lot,'' ``sample,'' and
``analytical unit'' found in Sec. 103.3 in part 165. Because FDA was
proposing to remove the quality standard from Sec. 103.35 and include
it in Sec. 165.110, FDA tentatively concluded that the definition of
these terms should be moved as well.
87. One comment objected to a provision in Sec. 165.3(b) that
states that ``a sample consists of 10 subsamples (consumer units)''
because this amount of testing is too costly. It stated that a better
procedure would be to analyze at least one sample for coliforms and
heterotrophic plate count for each size of container and each type of
product from one lot.
This comment falls outside the scope of this rulemaking. The agency
did not propose to amend the current definitions but only to move these
definitions to be in proximity with the bottled water standard in part
165. Therefore, FDA is not modifying the general definitions at this
time. However, persons interested in an amendment of the definitions
for ``lot,'' ``sample,'' and ``analytical unit'' may petition the
agency, providing recommended definitions and justification for the
recommendations.
A. Exemptions for Mineral Water
The agency tentatively concluded in the January 1993, proposal that
certain aesthetically based allowable levels should not apply to waters
with more than 500 ppm TDS. Accordingly, the agency proposed to add a
footnote to the list of allowable levels in Sec. 165.110(b)(4)(i)(A) to
provide that when water is labeled as ``mineral water,'' it will be
exempt from the allowable levels for color, odor, TDS, chloride, iron,
manganese, sulfate, and zinc. However, FDA did not propose to include
bottled waters that are not conspicuously identified with the term
``mineral'' or that are identified as ``mineral water, low mineral
content'' in this exemption because consumers will not generally expect
to encounter flavors affected by high mineral content in these bottled
water products. In addition, the agency did not propose to exempt
mineral water from the allowable levels for copper, fluoride, silver,
and turbidity. The agency requested comment concerning the need to
establish a separate turbidity level for mineral water.
The agency stated in the January 1993, proposal that, if it
established an allowable level for aluminum, it would propose to exempt
mineral water (except low-mineral-content type mineral waters) from
that standard because the standard is intended to control the aesthetic
properties of the water (turbidity) and not its effect on the body. In
the December 1994 final rule, the agency established an allowable level
of 0.2 mg/L for aluminum in bottled water. In a proposal published
elsewhere in this issue of the Federal Register, the agency is
proposing to exempt mineral water from the allowable level for
aluminum.
88. Three comments stated that mineral water should be subject to
all of the same regulations (including the TDS maximum allowable level)
as bottled water with no exceptions. However, the comments provided
nothing to support this position.
[[Page 57109]]
The agency disagrees with these comments. For the most part,
mineral water is subject to the same requirements as bottled water. FDA
is only exempting mineral water that contains more than 500 ppm TDS
from the maximum level requirements for chloride, iron, manganese,
sulfate, zinc, and total dissolved solids in Sec. 165.110(b)(4) (see
footnote 1 to Sec. 165.110(b)(4)(i)(A)). The agency established these
maximum levels based on aesthetic factors and not health or safety
factors (27 FR 2152, March 6, 1962). Most mineral waters exceed the
quality requirement of 500 mg/L for total dissolved solids because they
contain higher levels of these minerals than other types of bottled
water. The comments have not provided any basis for modifying the
exemption for mineral water, only the general request that the agency
do so. Given the nature of mineral water, and the fact that the
exemption it is granting only has aesthetic significance, FDA finds no
reason to make a change in Sec. 165.110(b)(4) in response to these
comments.
89. Several comments supported the proposed exemption from
secondary aesthetic-based maximum limits in the case of mineral water.
However, they urged the agency not to limit the exemption only to
mineral waters containing more than 500 mg/L. They requested that all
mineral waters, regardless of their TDS content, be exempt from the
secondary aesthetic-based maximum limits. The comments stated that
given that there is no consumer safety concern for these secondary
maximum levels, there is no reason to limit the exemption to mineral
waters with a TDS above 500 mg/L. One comment noted that a mineral
water with 490 ppm TDS, 0.4 mg/L iron, and 0.08 mg/L manganese and a
mineral water with the same iron and manganese content but with 510 ppm
TDS would be identical from an analytical perspective, but one would be
substandard, and the other would not.
In the January 1993 proposal (58 FR 393 at 401), FDA stated that it
did not include bottled waters that are not conspicuously identified
with the term ``mineral,'' or that are identified as ``mineral water,
low mineral content,'' in the exemption because consumers will not
generally expect to encounter flavors affected by high mineral content
in these bottled water products.
The agency agrees that there are no consumer safety concerns for
these secondary maximum levels. The exemption from the quality standard
for mineral water is based on allowable levels that were established
for aesthetic reasons and not for consumer safety. The allowable levels
from which mineral water is exempted are color and odor (physical
quality) and chloride, iron, manganese, sulfate, total dissolved
solids, and zinc (chemical quality). Water containing less than 500 ppm
TDS will not exceed the allowable levels for chloride, sulfate, or
total dissolved solids because of the high allowable levels in the
standard. In addition, it is unlikely that water containing less than
500 ppm TDS would exceed the allowable levels from which mineral water
is exempted.
The agency must consider whether consumers would expect products
labeled as ``mineral water, low mineral content'' to contain
objectionable aesthetic characteristics. Clearly, consumer expectations
exist that products labeled as ``mineral water'' may contain unique
aesthetic characteristics (Ref. 21). Because products containing less
than 500 ppm TDS are labeled as ``mineral water,'' FDA finds that
consumers will be informed that the product may contain objectionable
aesthetic characteristics. Therefore, FDA concludes that the exception
should also apply to ``mineral water, low mineral content.'' FDA is
modifying the footnote to Sec. 165.110(b)(3) and
Sec. 165.110(b)(4)(i)(A) to include all mineral water, including that
containing less than 500 ppm TDS.
90. Some comments stated that it might be appropriate for the
agency to clarify in the text of the regulation that the standards for
which an exemption is provided for mineral water are aesthetically
based and do not relate to a health concern.
FDA agrees that the exemptions from the allowable levels in the
standard are for those that are based on EPA secondary maximum
contaminant levels (SMCL's), which were established for aesthetic
reasons and not for health or safety reasons, although the agency is
not exempting mineral water from all of the allowable levels based on
EPA's SMCL's. FDA finds that the requested modification in the footnote
of the regulation would clarify the intent of the exemption. Therefore,
the agency is modifying the footnote to Sec. 165.110(b) to state that
the exemptions are aesthetically based allowable levels and do not
relate to a health concern.
91. Some comments urged the agency to exert caution concerning
certain harmless, naturally occurring minerals that the agency
characterizes as possibly causing negative aesthetic effects. They
urged the agency to consider the rate of consumption by consumers of
mineral waters containing these compounds before making any final
decision.
The agency assures the commenters that, as it considers how EPA's
SMCL's should apply to bottled water and to mineral water in
particular, FDA has evaluated, and will continue to evaluate, whether
the aesthetic effect of the substance will be of concern to consumers.
This evaluation includes a consideration of the rate of consumption of
mineral water. The agency is exempting mineral water from some but not
all allowable levels that are based on EPA's SMCL's. As FDA explained
in response to the previous comment, FDA has formulated the quality
standards to protect consumers from any adverse effects on the body,
even those that may be characterized as aesthetic.
92. One comment recommended that FDA reexamine the allowable levels
for fluoride in the case of carbonated mineral water packaged in bottle
sizes of 1.5 L or less because consumers will not use products packaged
in these types of containers as a tap water alternative, and there will
be a much lower average daily intake of these products. The comment
stated that it would promote fairness towards existing mineral water
bottlers by setting standards in a manner that is the same as that used
for other food products. It suggested that the maximum allowable
concentration of fluoride be no greater than 3.0 ppm for carbonated
mineral waters, where the TDS is between 500 and 1000 ppm, and up to
6.0 ppm where the TDS is above 1000 ppm.
Another comment recommended that FDA set the fluoride limit for
bottled waters at 2 ppm. The comment said that this limit is a feasible
one for mineral water producers to meet. As an alternative, based on
the theory that children rarely consume much of the high-mineral waters
that are likely to have a high fluoride level, the comment suggested
that FDA permit a fluoride content of more than 2 ppm in mineral
waters, provided that the label bear this prominent warning: ``Not
recommended for use by children; fluoride content can contribute to a
significant risk of dental mottling.''
FDA disagrees that mineral water should be exempt from the maximum
levels for fluoride for bottled water. Although mineral water may not
be consumed in as great a quantity as other types of water, consumers
may obtain fluoride from other sources, and thus, mineral water can
contribute to excessive total consumption of this mineral.
The agency notes that the quality standard sets forth maximum
levels for fluoride. FDA proposed a revised allowable level for
fluoride of 2.0 ppm
[[Page 57110]]
for naturally occurring fluoride in bottled water (53 FR 36063 at
36067, September 16, 1988). The agency will be proceeding with that
rulemaking now that EPA has published a notice of intent not to revise
its fluoride drinking water standards (58 FR 68826, December 29, 1993).
The label of bottled water, including mineral water, containing
fluoride at levels greater than the maximum allowable levels of
fluoride in Sec. 165.110(b)(4)(ii) must bear the statement ``contains
excessive fluoride'' in accordance with Sec. 165.110(c)(3).
93. One comment stated that, if in the final rule FDA allows an
exemption for sulfate in mineral water containing more than 500 ppm
TDS, FDA should require that all bottled water containing sulfates
display labels with language similar to the following: ``Warning, this
product may contain high levels of sulfate which may cause diarrhea in
sensitive population groups including infants, children, and pregnant
women.'' It stated that this statement should be a minimum requirement
because there is evidence that sensitive population groups are
susceptible to harmful effects from products that contain sulfates.
The agency notes that in the Federal Register of December 20, 1994
(59 FR 65578), EPA proposed a MCLG and a National Primary Drinking
Water Regulation (NPDWR) including a MCL of 500 ppm TDS for sulfate.
EPA stated that sulfate is a unique contaminant because the health
effect associated with the ingestion of relatively high levels of
sulfate in drinking water (i.e., ranging from loose stools to diarrhea)
is acute and temporary and is expected to last approximately 2 weeks.
In addition, EPA stated that the health risk only applies to persons
not already acclimated to high sulfate-containing water--infants,
travelers, and new residents. EPA did not propose to amend the SMCL of
250 mg/L for sulfate that is based on aesthetic effects (i.e., taste
and odor).
In the Memorandum of Understanding (MOU) concerning the control of
drinking water, EPA and FDA agreed that the authority to control
substances in drinking water should be vested with EPA to avoid
duplicative and inconsistent regulation. Therefore, FDA is not
establishing a maximum allowable level for sulfate in mineral water at
this time. However, if EPA establishes an MCL for sulfate in public
drinking water, in accordance with section 410 of the act (21 U.S.C.
349), FDA will consider amending the bottled water quality standard to
establish a maximum allowable level for sulfate in mineral water.
The agency is exempting mineral water from the allowable level for
sulfate of 250 ppm at this time because some mineral waters exceed this
aesthetically determined level without causing any adverse effects
(Ref. 22). However, if mineral water contains sulfate, or any other
substance, at a level that is injurious to health, it is deemed to be
adulterated and subject to regulatory action.
94. One comment stated that under the January 1993 proposal,
bacteriologically and chemically pure artesian or mineral water, for
example, that is safe for consumers would have to bear the label
statement ``abnormal color and smell,'' even if the ``abnormal'' color
and smell results from perfectly normal, naturally occurring dyes and
gasses that are constituent to its source. The comment contended that
these substances make the water unique by their individual combination
and are often sought or favored by consumers, both domestically and
internationally. It stated that the designation ``abnormal'' on
unadulterated, uncontaminated water is an inappropriate requirement for
labeling. It stated that it is especially inappropriate when the source
waters are unique, identified as to their source, and otherwise pure,
natural, and uncontaminated.
FDA established the physical quality standards concerning color and
odor based on EPA SMCL's. These allowable levels were established for
aesthetic reasons and not to ensure consumer safety. The primary
purpose of a quality standard is to establish the minimum acceptable
quality criteria for a product when it is offered to consumers. The
quality standard for bottled water is based on the normal range of
waters, and a consumer's expectation is also based on the normal range
of waters. Thus, the label needs to respond to that expectation and not
be tailored to individual situations. Because bottled water that does
not meet the color and odor quality standard may be objectionable to
consumers, the labeling requirements established in the standard
continue to be appropriate for bottled water in general.
Therefore, bottled water (e.g., artesian water) that is not
exempted from the quality standard and that exceeds the maximum
allowable levels for color or odor must bear the label statements
``Abnormal Color'' or ``Abnormal Odor'' as required by
Sec. 165.110(c)(2). However, the agency points out that in the case of
mineral water, products that do not meet the color and odor quality
standard are exempted from the standard.
B. Substandard Chemical Quality Labeling
In the January 1993 proposal, FDA tentatively concluded that the
general phrase, ``Contains Excessive Chemical Substances,'' may not be
adequate for mineral water and proposed that the label or labeling of
mineral water list the specific names of any substances present in
amounts that exceed the allowable levels to which mineral water is
subject (e.g., ``Contains Excessive Fluoride,'' ``Contains Excessive
Trihalomethanes'').
95. Two comments objected to allowing bottlers to distribute a
product that does not meet the water quality standards. One comment
stated that the purpose of water quality standards is to prevent
products that are below acceptable standards from being distributed to
consumers. It noted that given the emphasis by the bottled water
industry on the quality of bottled water versus tap water, it is quite
doubtful that bottlers would print any substandard notice on the
product label. Another comment questioned whether consumers would be
able to interpret the significance of the phrase ``contains excessive
chemical substances'' on a label. It requested that FDA require at a
minimum that the specific chemical substances be listed similar to
FDA's proposal for substandard mineral water.
One comment questioned whether bottled water exceeding the
microbiological standards should be sold at all, regardless of how it
is labeled.
FDA notes that under section 403(h)(1) of the act, a food is deemed
to be misbranded if it is a food for which a standard of quality has
been prescribed by regulation, and its quality falls below such
standard, unless its label bears, in such manner and form as such
regulations specify, a statement that it falls below such standard.
Bottled water may be sold even though it contains a substance at a
level that exceeds the maximum allowable levels in the quality standard
so long as that substance does not adulterate the food under section
402 of the act. However, the agency points out that most of the maximum
allowable levels in the bottled water quality standard are identical to
EPA MCL's, and EPA establishes its levels based on health
considerations. Therefore, many substances, including microorganisms
(e.g., coliforms), present in amounts exceeding FDA's maximum allowable
levels could be present at levels that are injurious to health.
[[Page 57111]]
The agency disagrees with the request that it require, at a
minimum, that the specific chemical substances that exceed the maximum
allowable levels in Sec. 165.110(b)(4) to be listed on the label
instead of providing the exception in Sec. 165.110(c)(3) if the bottled
water is not mineral water. The chemical content of mineral waters
generally exceeds one or more allowable levels in the bottled water
standard, and thus, consumers would expect mineral water to normally
contain excessive chemicals. As discussed above, the agency has
exempted mineral water from certain allowable levels in the quality
standard on this basis. Consumers would not expect bottled water that
is not mineral water to contain any excessive chemicals because the
quality standard is based on the normal range of waters.
Therefore, the agency concludes that the statement ``contains
excess chemical substances'' is appropriate for bottled water other
than mineral water, and that it is not necessary to require more
specific labeling because consumers will be alerted to the presence of
chemical substances in amounts that exceed the maximum allowable
levels. However, the agency does not object to the labeling of bottled
water that declares the substandard presence of specific chemicals in
lieu of the more general statement ``contains excess chemical
substances.''
FDA notes that it has made a number of editorial modifications in
Sec. 165.110(c), including deleting and renumbering several of the
provisions that appeared in the proposal, for clarity.
IV. Current Good Manufacturing Practices
A. Product Water, Operations Water, and Compliance Procedures
On January 5, 1993, the agency proposed to update the references in
Sec. 129.35 and to delete the exclusion for mineral water from testing
requirements in Sec. 129.80(g). FDA also proposed to permit firms that
use a municipal water system as the source of their water to substitute
municipal testing results showing full compliance with the EPA primary
and secondary drinking water regulations (or a certificate to this
effect) for the source water chemical contaminant testing required in
Sec. 129.35(a)(3). In addition, the agency proposed to permit firms
that use a nonmunicipal water source as the source of their water to
reduce the frequency of testing and the number of chemical contaminants
for which they test source water if they can document that such
reduction is consistent with a waiver that the State has issued under
EPA regulations (Sec. 129.35(a)(4)(ii)).
96. Several comments suggested that FDA use the term ``public water
supply'' as defined by EPA rather than use the term ``municipal
supply.'' (See previous discussion in comment 72.)
The agency notes that it used the term ``municipal water system''
in proposed source water testing exemptions in Sec. 129.35(a)(4) (58 FR
393 at 407). However, FDA agrees that in the context of this section,
the term ``public water system'' is more appropriate because it
includes water that is covered by EPA's drinking water regulations and
State programs established under EPA programs. The intent of FDA's
testing exemptions was to apply to water based on whether or not the
source was a public water system. Therefore, the agency is modifying
Sec. 129.35(a)(4)(i) to include firms that use a public water system
for source water and Sec. 129.35(a)(4)(ii) to include firms that do not
use a public water system.
97. One comment requested that all types of nonmunicipal sources
maintain documentation on file that establishes that the source has
been evaluated and determined to meet the design, operation, and
maintenance requirements of the government agency having jurisdiction.
The agency advises that firms must have source approval of their
product water and must maintain records of the source approval.
According to Sec. 129.3(a), an ``approved source,'' when used in
reference to a plant's product water or operations water, means a
source of water and the water therefrom, whether it be from a spring,
artesian well, drilled well, municipal water supply, or any other
source, that has been inspected, and the water sampled, analyzed, and
found to be of a safe and sanitary quality, according to the applicable
laws and regulations of the State and local government agencies having
jurisdiction. The presence in the plant of current certificates or
notifications of approval from the government agency or agencies having
jurisdiction constitutes approval of the source and the water supply.
Therefore, no action is necessary in response to the comment.
98. Comments stated that no standards are set to protect a well or
spring and its recharge area against the intrusion of contaminants. One
comment stated that there should be very strict rules governing
ownership, control, and protection of the recharge area of any well or
spring.
FDA agrees that the recharge area of any well or spring is a
critical area. However, the agency disagrees that it is necessary to
establish requirements concerning ownership, control, and protection of
the recharge area of any well or spring because it has already
established requirements in parts 129 and 165 to guard against the
presence of contaminants in bottled water, whether from the recharge
area or any other source of contamination.
First of all, the source of the water must be an approved source,
and the water found to be of a safe and sanitary quality by the
government agency approving the source (Sec. 129.35(a)). Such source
approval could include the source of recharge to determine whether the
water will be of a safe and sanitary quality.
In addition to meeting the requirements of part 129, bottled water
must meet the requirements of the quality standard in Sec. 165.110(b)
or be labeled as substandard in accordance with Sec. 165.110(c). The
quality standard lists allowable levels for many common contaminants of
recharge areas (e.g., pesticides and nitrates).
Finally, as stated in Sec. 165.110(d), bottled water containing a
substance at a level considered injurious to health under section
402(a)(1) of the act is deemed to be adulterated, regardless of whether
or not the water bears a label statement of substandard quality.
Therefore, the agency concludes that consumers are protected against
problems that may occur in the recharge area of a spring or well used
as a source for any bottled water product.
99. One comment stated that any water under the influence of
surface water must be treated as surface water and should never be
called ``spring water,'' ``well water,'' or ``natural water,''
regardless of whether it was collected from a spring or pumped from a
well.
Another comment stated that, in general, the microbiological
standards in the proposed regulation are weak and do not address the
issue of ground water under the influence of surface water. The comment
urged FDA to incorporate appropriate source approval standards similar
to those of the State of North Carolina as a means to ensure safe
bottled spring and well waters.
One comment requested that FDA state that spring water must not be
under the direct influence of surface water. The comment stated that a
requirement, such as an initial water particulate test during the rainy
season, should be considered for spring water.
The agency agrees that any water under the direct influence of
surface water is not ground water, regardless of whether it was
collected from a spring or pumped from a well. EPA defines
[[Page 57112]]
``ground water under the direct influence of surface water'' in 40 CFR
141.2 as any water beneath the surface of the ground with significant
occurrence of insects or other macroorganisms, algae, or large diameter
pathogens such as Giardia lamblia, or significant and relatively rapid
shifts in water characteristics such as turbidity, temperature,
conductivity, or pH which closely correlates to climatological or
surface water conditions. The manifestation of any of these factors
evidences that the source is under the direct influence of surface
water and is, therefore, not a ground water source. The definitions of
``spring water,'' ``artesian water,'' ``mineral water,'' and ``well
water'' that FDA is adopting in this document require that the source
be a ground water source.
EPA has published a Consensus Method for Determining Groundwaters
Under the Direct Influence of Surface Water Using Microscopic
Particulate Analysis (MPA) (Ref. 23). The consensus method is the
result of a collaborative effort combining the experiences and
knowledge of contributors from around the country into an acceptable
consensus method. This guidance may be used to determine whether ground
water is under the direct influence of surface water. This
determination may be considered as part of the source approval
conducted by the State or local agency having jurisdiction because,
under Sec. 129.3(a), source water must be found to be of a safe and
sanitary quality.
FDA adds that it published a proposal, to amend the quality
standard for bottled water to require that bottled water be free of
coliform bacteria (58 FR 52042). In that proposed rule, FDA also
addressed other matters concerning the microbiological quality of
bottled water and requested comments on whether the agency should
establish quality standard regulations for other microorganisms that
may be present in bottled water and pose a health hazard. The agency
will discuss the comments that it received in response to that proposal
in that rulemaking.
100. One comment recommended added testing for bacteriological
contaminants, trihalomethanes, lead, and copper in those situations
where the bottled water manufacturers will be permitted to substitute
municipal test results for the testing requirements of
Sec. 129.35(a)(3). It stated that additional testing is necessary for
these contaminants because of contamination that could occur in the
water distribution system.
One comment stated that allowing bottled water producers that use a
municipal water source to substitute municipal testing results for the
source testing requirements is reasonable only if the final product
testing requirements are retained.
FDA disagrees that it should require additional testing by bottled
water manufacturers who substitute public water system test results for
source water testing. However, the agency agrees with the comment that
stated that the substitution of public water system test results for
source water testing is appropriate only if the final product is tested
according to the requirements in Sec. 129.80(g). The testing exemptions
for microbiological contaminants that FDA established previously
(Sec. 129.35(a)(3)(i)) and for chemical contaminants that FDA is
establishing in this rulemaking (Sec. 129.35(a)(4)(i)) apply to the
source water testing requirement only. Part 129 also requires testing
of product water (i.e., after processing but prior to packaging) and
finished product. Under Sec. 129.80(a), product water samples must be
taken after processing and before bottling by the plant and analyzed as
often as is necessary to ensure uniformity and the effectiveness of the
processes performed by the plant. In addition, under Sec. 129.80(g)(1)
and (g)(2), a bottled water plant must analyze a representative sample
of the finished product of each type of bottled drinking water at least
once a week for the presence of bacteria and at least annually for
chemical contaminants.
The agency concludes that no additional chemical or microbiological
testing requirements are necessary for bottled water manufacturers who
use public water systems and who substitute testing results from the
public water system for source water testing requirements in part 129
because FDA requires that product water and finished product water be
regularly tested, and if any contaminant is contributed by the water
distribution system it will be detected by the required testing. The
testing requirements in Sec. 129.80 have functioned satisfactorily
since FDA adopted them in 1979 (44 FR 12173, March 6, 1979), and the
agency finds no reason to amend them. FDA points out that its adoption
of the source water testing exemptions in Sec. 129.35(a)(4) in no way
changes how product water and finished product water are to be tested.
101. Two comments objected to Sec. 129.35(a)(4)(ii) regarding a
waiver for nonmunicipal water used by firms for the purposes of
manufacturing bottled water. They stated that under proposed
Sec. 129.35(a)(4)(ii), a firm could reduce the number of contaminants
for which it tests, and the frequency with which it performs testing,
if it can document that such reduction is consistent with a waiver that
the State has issued under EPA regulations. The comments stated that
FDA should not allow a manufacturer to establish that such a waiver
exists but should require the governmental entity regulating the source
to make such a determination.
The agency disagrees with the comments. Firms may reduce the
frequency of testing and the number of chemical contaminants for which
they test source water if they can document that such reduction is
consistent with a State-issued waiver under EPA regulations for public
water systems. State waivers may either eliminate the requirement for a
3-year compliance period (e.g., pesticides/polychlorinated biphenyl's
(PCB's)) or reduce the frequency of testing (e.g., inorganics and
volatile organic chemicals). Waivers are either based on a review of
established criteria (``a waiver by rule'') or on a vulnerability
assessment. In the Federal Register of January 30, 1991 (56 FR 3526 at
3562), EPA discussed the criteria for waivers by ``rule'' and
``vulnerability assessment.''
EPA may rescind waivers issued by a State where EPA determines that
the State has issued a significant number of inappropriate waivers. If
a waiver is rescinded, the firm must monitor in accordance with the
requirements in Sec. 129.35.
States develop their own specific vulnerability assessment
procedures that use the general guidelines established by EPA. If a
State chooses not to develop these procedures, firms cannot receive
waivers and must monitor the source water in accordance with
Sec. 129.35.
Therefore, firms cannot decrease the amount of testing that they
perform unless the State has issued a waiver to them. The presence of a
current State-issued document in the plant will certify that testing of
source water may be reduced. The reduction in testing is only for those
contaminants covered by the waiver. If the State has not issued such a
waiver, the firm must annually test for all contaminants.
FDA points out that the State-issued waiver from chemical testing
requirements in Sec. 129.35(a)(4) applies only to source water testing,
and that the product water must be tested in accordance with
Sec. 129.80(a). Moreover, the finished product must be tested for all
substances in accordance with Sec. 129.80(g). Thus, FDA concludes that
no modification of Sec. 129.35(a)(4)(ii) is warranted.
102. One comment recommended that Sec. 129.35(a)(4)(ii) be modified
to require that at least two complete samples for
[[Page 57113]]
all contaminants be made before any reduction in testing is allowed,
even when the State has issued a waiver. It stated that there can be
great variation in contaminant levels in both surface and ground water
sources, even with withdrawal points that are in close proximity. The
comment claimed that a requirement for initial sampling is the only way
to ensure that waivers are appropriate, and that, where firms make use
of this testing exception, they should be required to maintain the data
from initial sampling and support documentation on State waivers
indefinitely rather than for the 2-year period typically required for
test data.
The agency disagrees with the comment. As EPA explained in the
Federal Register of January 30, 1991 (56 FR 3526 at 3562), waivers are
granted on a contaminant-by-contaminant basis. Waivers for pesticides/
PCB's and volatile organic chemicals (VOC's) may be granted after the
firm conducts a vulnerability assessment, and the State determines that
the source is not vulnerable based on that assessment. A waiver must be
renewed every 3 years (id.). Waivers for inorganic contaminants (except
nitrate/nitrite) may be granted for up to 9 years. If a firm does not
receive a waiver, it must comply with the requirements in Sec. 129.35.
The vulnerability assessment is based on a two-step waiver
procedure. Step 1 determines whether the contaminant was used,
manufactured, stored, transported, or disposed of in the area. In the
case of some contaminants, an assessment of the contaminant's use in
the treatment or distribution of water may also be required. ``Area''
is defined as the watershed area for a surface water system or the zone
of influence for a ground water system and includes effects in the
distribution system. If the State determines that the contaminant was
not used, manufactured, stored, transported, or disposed of in the
area, then the system may obtain a ``use'' waiver. Systems receiving a
``use'' waiver are not required to continue on to Step 2 to determine
susceptibility. EPA anticipated that most ``use'' waivers will be for
pesticides/PCB's, the use of which can be determined more easily than
for VOC's. Obtaining a use waiver for the VOC's will be limited because
VOC's are ubiquitous in the United States (56 FR 3526 at 3562).
If a use waiver cannot be given, that is, if the State cannot make
a determination that the contaminant was not used, manufactured,
stored, transported, or disposed of in the area, a system may conduct
an assessment to determine susceptibility (Step 2). Susceptibility
considers prior occurrence or vulnerability assessment results,
environmental persistence and transport of the chemical, the extent of
source protection, and EPA Wellhead Protection Program reports. Systems
with no known ``susceptibility'' to contamination based upon an
assessment of the above criteria may be granted a waiver by the State.
If ``susceptibility'' cannot be determined, a system is not eligible
for a waiver (56 FR 3526 at 3563).
EPA also established guidelines for decreased monitoring of
inorganic chemicals (56 FR 3526 at 3564). States may decide, based on
prior analytical results, variation in analytical results, and system
changes such as pumping rates or stream flows/characteristics, to allow
firms to reduce the monitoring frequency to no less than 9 years. To
qualify for this waiver, at a minimum, three previous compliance
samples must have been reliably and consistently less than the MCL.
The above minimum guidelines, along with any additional State
requirements, provide adequate consumer protection because a firm must
perform appropriate testing before a waiver will be issued. In
addition, the use or susceptibility requirements of the program provide
assurances that a contaminant is not present in the area. Finally, the
waiver does not extend to testing of the product water and the finished
product. Thus, FDA concludes that the requirements for obtaining the
waiver adequately address consumer safety concerns.
Firms must document that they have a current State-issued waiver,
and that the waiver complies with State requirements even though the
waiver may have been issued prior to the 2-year record retention time
period required by Sec. 129.80(h). Records of the waiver must be
retained for not less than 2 years after the waiver expires to meet the
requirements of Sec. 129.80(h). This retention requirement ensures that
all testing records, exemptions from testing, and source approval
requirements are documented for the same production batch of bottled
water. However, the agency sees no need for manufacturers to maintain
these records indefinitely, and the comment has not provided grounds
for such a requirement.
103. One comment asked whether FDA is requiring the same sampling
frequency as is required for public systems under EPA's Phase II rules
(56 FR 3526) by including the waiver process in this regulation. The
comment stated that, for example, inorganics could be tested at a
frequency of once every 9 years according to EPA regulations. It asked
whether FDA feels that such a frequency of testing provides adequate
protection of source water.
The agency notes that manufacturers must comply with all the source
testing requirements in Sec. 129.35(a)(3) unless they have received a
State-issued waiver for specific contaminants. As discussed above,
under EPA's Phase II rules (56 FR 3526), States may issue waivers only
if circumstances affecting the source and the area surrounding the
source make it unlikely that the contaminant will be present. Based on
its review of the evidence on these factors, the State may issue a
waiver decreasing the frequency of testing from 3 to 9 years depending
on the contaminant.
FDA believes that the use of a State-issued waiver is an
appropriate substitute for source water testing because a State must
require that the water be tested before issuing the waiver, and that
the conditions relevant to the occurrence of the contaminant confirm
that it is unlikely that the contaminant will be present. Again, FDA
affirms that the finished bottled water must be tested at least
annually for chemical contaminants and comply with FDA regulations.
104. One comment stated that, because the source has no bearing on
the final product for purified or distilled water, there was reason to
question whether it was necessary for a bottler that bottles only
purified water to have annual chemical and radiological tests of its
source water.
FDA disagrees with the comment. Source testing is important to
ensure the purity of the source water. The source water must be of
reasonable quality to ensure that the finished product complies with
the quality requirements. If a source contains excessively high levels
of some contaminants, these contaminants may not be adequately removed
in the purification process. Therefore, the agency concludes that the
source water for purified water should not be exempt from all the
requirements of part 129. However, the agency notes that there are
source water testing exemptions in Sec. 129.35(a)(4) that may apply to
the source water for purified water. If applicable, these exemptions
could replace or reduce the source testing requirements for chemical
contaminants.
105. One comment expressed concern about FDA regulating the testing
of source water if FDA would preempt State agencies from setting
standards for source water that are equivalent to State Drinking Water
Standards. The comment held that the State should have the authority to
set more stringent standards for source water when there is
[[Page 57114]]
a safety issue. It noted that water bottled in a State should have at
least the same health-based quality standards as public drinking water
in that State. The comment questioned whether FDA has jurisdiction over
source water and was opposed to FDA regulating the water quality
standards for source water, which are under the jurisdiction of the
States or EPA.
The agency notes that it is not amending its regulations with
respect to the testing of source water except to provide that bottlers
using a public water supply may substitute certificates showing
compliance with EPA's requirements for chemical contaminants for
testing results, and that bottlers may use a State-issued waiver for
some chemical contaminants. Section 129.35(a)(3) specifies the
frequency of testing of source water for chemical, radiological, and
microbiological contaminants. This sampling is in addition to any that
is performed by government agencies having jurisdiction. The source is
approved by the State or local government agency having jurisdiction
and must comply with the applicable laws of that agency, even though
those laws are more stringent than FDA requirements. FDA has
traditionally relied on the laws of the State or locality having
jurisdiction. Therefore, FDA concludes that there is no basis for the
concern expressed by the comment.
B. Additional Definitions
Although the agency did not propose definitions for ``bottled water
plant,'' ``plant operator,'' or ``water dealer,'' or to revise the
definition for ``bottled drinking water,'' as IBWA requested, FDA
requested comment from interested persons on the need to define or
amend the definitions of these terms.
106. One comment recommended that FDA define ``bottled water
plant.'' It stated that such a definition would enable States that have
bottled water regulations to adopt a uniform definition.
The agency has decided that it is not necessary to adopt a
definition for ``bottled water plant.'' Part 110, concerning CGMP in
manufacturing, packing, and holding human food, applies to bottled
water along with part 129. Under Sec. 110.3(k), ``plant'' means the
building or facility or parts thereof, used for or in connection with
the manufacturing, packaging, labeling, or holding of human food. Thus,
``bottled water plant'' can be fairly interpreted, under FDA's
regulations, to mean the building or facility or parts thereof, used
for or in connection with the manufacturing, packaging, labeling, or
holding of bottled water. In its petition, IBWA defined ``bottled water
plant'' as any place or establishment in which bottled water is
prepared for sale. The State of California defines ``water-bottling
plant'' as any facility in which bottled water is produced (Ref. 2).
Thus, FDA concludes that the definition in Sec. 110.3(k) is adequate
because it is consistent with the common definition of a bottled water
plant, and that a specific definition for this term in part 129 is not
necessary.
C. Unregulated Contaminants
IBWA requested revision of part 129 to provide for additional
source and final product testing requirements in Sec. 129.35 to detect
and control specific unregulated contaminants. The agency did not
propose to require such testing because firms are free to test for
contaminants not listed in the quality standard, and they must employ
appropriate quality control procedures to ensure that food is suitable
for human consumption (Sec. 110.80). In addition, bottled water that
contains a poisonous or deleterious substance is subject to regulatory
action under the adulteration provisions of the act. Producers that
knowingly produce and distribute adulterated bottled water may be
subject to the criminal penalties of the act.
107. One comment requested that FDA amend Sec. 129.35 to require
testing of bottled water products (on at least an annual basis) for
those substances listed in EPA's requirements for monitoring of
unregulated contaminants. It stated that this requirement should be
made immediately applicable to all bottled water producers.
The agency disagrees with the comment. Under section 1445(a) of the
SDWA, EPA was required to promulgate monitoring requirements for
unregulated contaminants. EPA established monitoring requirements for
51 synthetic organic chemicals in the Federal Register of July 8, 1987
(52 FR 25690), and promulgated monitoring requirements for an
additional 30 synthetic organic chemicals and inorganic chemicals in
the Federal Register of January 30, 1991 (56 FR 3526), that were not
regulated by NPDWR's to assist EPA in establishing future NPDWR's. EPA
did not establish regulations that would set forth maximum levels of
these contaminants, only the requirement that public water systems
monitor for them.
FDA does not believe that it is necessary to mandate testing for
unregulated contaminants in bottled water because such testing is for
EPA monitoring and information purposes only. As EPA identifies the
need to regulate a substance from its monitoring activities, and
subsequently adopts MCL's for them, FDA will promulgate applicable
regulations for bottled water under section 410 of the act (21 U.S.C.
349). The comment did not provide a basis to establish a requirement
for additional testing. It only requested that FDA do so. Therefore,
the agency concludes that amending Sec. 129.35 in the manner suggested
by the comment is not warranted.
108. One comment stated that additional final product testing
should be required for any contaminants that can enter the water
through the water system or through the bottles. It stated that these
contaminants, given their low levels, may not be poisonous or
immediately deleterious but should not be in bottled water. The comment
stated that several years ago, a California firm used a new clear resin
that was subsequently found to be leaching cyclohexanes, among other
things. It stated that at least one consumer injury was reported when a
particularly bad batch of resin was used. The comment cited another
instance of chemicals entering the water from improperly cured new
piping. It stated that in these instances, the required source water
monitoring for additional contaminants would not have uncovered the
problem in the finished product.
FDA disagrees that it should establish additional finished product
testing requirements for chemical contaminants derived from processing
equipment or packaging. Substances that get into the product from
product contact surfaces can vary from manufacturer to manufacturer and
from lot to lot. The agency considers these substances to be indirect
food additives. Thus, any product that contains such a substance whose
use has not been regulated by FDA will be deemed to be adulterated
under section 402(a)(2)(C) of the act (21 U.S.C. 342(a)(2)(C)) in that
it contains an unsafe food additive.
Under Sec. 129.40(a), all plant equipment and utensils must be
suitable for their intended use. Included under the coverage of this
section are all collection and storage tanks, piping, fittings,
connections, bottle washers, fillers, cappers, and other equipment that
may be used to store, handle, process, package, or transport product
water. All product water contact surfaces must be constructed of
nontoxic and nonabsorbent material that can be adequately cleaned and
sanitized and that is in compliance with section 409 of the act (21
U.S.C. 348). Furthermore, Sec. 129.80(f) requires that only nontoxic
containers and closures be used. ``Nontoxic materials'' is
[[Page 57115]]
defined in Sec. 129.3(e) as materials for product water contact
surfaces, used in the transporting, processing, storing, and packaging
of bottled drinking water, that are free of substances that may render
the water injurious to health or that may adversely affect the flavor,
color, odor, or bacteriological quality of the water. Therefore, the
agency concludes that there are already adequate provisions in part 129
to address the comment's concern, and that no modifications are
necessary.
D. Microbiological Control Standards
IBWA requested revision of Sec. 129.40 to include microbiological
control standards that included prohibitions from processing and
bottling water with equipment that has been used to produce milk, fruit
juice, or any other food product likely to contribute nutrients for
microbiological growth. FDA was not persuaded by the information that
IBWA submitted that the revision was needed.
109. A number of comments stated that FDA did not provide a
sufficient rationale for not requiring that firms use dedicated
equipment (i.e., equipment used solely for one product) for processing
bottled water. One comment stated that dedicated equipment, with the
exception of fillers, is an important precaution to maintain the
quality of bottled water.
One comment stated that FDA should prohibit equipment used for milk
production from being also used for bottled water production to protect
consumers from potential health hazards. It stated that there is a
greater potential of microbiological contamination of bottled water if
it is produced using equipment that is also used for milk production.
Another comment stated that high coliform and other bacteria counts
from either inadequate cleaning or inadequately trained personnel
improperly maintaining or operating the equipment has been a problem
with at least one California dairy that also bottles water.
Several comments were concerned that FDA proposed no restriction on
the use by water bottlers of: (1) Equipment used to transport, store,
process, or bottle nonfood products (e.g., pesticides, toxic
chemicals); and (2) equipment used to transport, store, process, or
bottle food products likely to contaminate bottled water with nutrients
for microbial growth. The comments stated that these equipment use
restrictions are important public health safeguards.
Conversely, other comments supported FDA's position that dedicated
lines for bottled water should not be a requirement. The comments noted
that only good sanitation will ensure a low probability of
microbiological contamination. One comment stated that the rationale
used by the agency is supportable based on the performance history of
the dairies and soft drink manufacturers that also produce bottled
water.
One comment stated that certified results confirmed that bottled
water produced by dairy plants equalled or exceeded the bacterial
quality of that produced by dedicated water bottlers. It stated that
all bottlers should be subject to the same quality and testing
regulations.
One comment from a dairy stated that a requirement for dedicated
equipment would eliminate that dairy from the bottled water market. The
comment stated that, because the firm is experienced in high quality
sanitation practices from bottling fluid milk products, it is confident
of its ability to meet regulatory product standards for consumer
safety.
One comment stated that, although milk, fruit juice, and other food
processing operations should not be prohibited from processing bottled
water, additional operational requirements should be imposed on these
types of processing plants because of the likelihood of mineral
deposits building up inside feed lines. The comment stated that these
mineral deposits tend to shield bacteria and other pathogens from
disinfection if standard disinfection practices are used.
FDA disagrees with the comments that stated that it should require
dedicated equipment for processing bottled water. Under Sec. 129.37(a),
the product water-contact surfaces of all multiservice containers,
utensils, pipes, and equipment used in the transportation, processing,
handling, and storage of product water must be clean and adequately
sanitized. All product water-contact surfaces must be inspected by
plant personnel as often as necessary to maintain the sanitary
condition of such surfaces and to ensure that they are free of scale,
oxidation, and other residues. The presence of any unsanitary
condition, scale, residue, or oxidation must be immediately remedied by
adequate cleaning and sanitizing of that product water-contact surface
before it is used again.
Section 129.40(a)(2) requires that all product water contact
surfaces be constructed of nontoxic and nonabsorbent material that can
be adequately cleaned and sanitized and that is in compliance with
section 409 of the act. Furthermore, Sec. 129.80(d) states that
sanitizing operations must be adequate to effect sanitization of the
intended product water-contact surfaces and any other critical area.
Therefore, the agency concludes that there already are appropriate
regulations in part 129 that adequately address the concerns of the
comments.
As FDA stated in the proposal (58 FR 393 at 403), dedicated
equipment will not ensure that the goal of production of foods with a
low probability of microbiological contamination will be met. Only good
sanitation will ensure that this goal is achieved. FDA does not require
dedicated equipment for any other food and is not persuaded that
dedicated equipment is necessary for bottled water. Bottled water
containing any substance considered injurious to health is adulterated
under section 402(a)(1) of the act.
Microbiological standards exist for bottled water in
Sec. 165.110(b)(2). Manufacturers must ensure that bottled water meets
the microbiological quality standards in Sec. 165.110(b)(2) or label
the product as substandard. If the product is deemed to be adulterated,
it cannot be sold at all.
In the Federal Register of October 6, 1993 (58 FR 52042), the
agency proposed to amend the quality standard to require that bottled
water be free of coliform bacteria. In addition, FDA addressed other
matters concerning the microbiological quality of bottled water and
requested comments on whether it should establish quality standard
regulations for other microorganisms that may be present in bottled
water and may pose a health risk. The agency intends to discuss the
comments that it received in response to that proposal in that
rulemaking.
E. Processes and Controls
IBWA requested revision of certain requirements in part 129
pertaining to filtration and germicidal treatment. FDA did not propose
the requested revisions but stated that it would consider adopting them
in other rulemakings. As stated above, the agency has proposed to amend
the quality standard for bottled water to require that bottled water be
free of coliform bacteria (58 FR 52042). In that proposal, FDA also
addressed other matters concerning the microbiological quality of
bottled water and requested comments on whether the agency should
establish quality standard regulations for other microorganisms that
may be present in bottled water and may pose a health risk. The agency
will discuss the comments that it received in response to that proposal
in that rulemaking.
110. Several comments urged FDA to require mandatory disinfection
of
[[Page 57116]]
bottled water with ozone or an equivalent disinfection process. Two
comments stated that failure to require treatment of mineral water with
ozone or an equivalent disinfectant process would reduce the level of
public health protection now provided.
However, some comments stated that bottled water need not be
disinfected if it meets the standards of the European Economic
Community Directive 80/777/EEC for Natural Mineral Water, July 15, 1980
(European Community), which mandates that numerous and frequent
microbiological analyses of the water be done to ensure its potability
in lieu of disinfection. One comment stated that mandatory disinfection
of mineral water that includes bottled water products covered by the
ERCS for ``natural mineral waters'' would constitute interstate
commerce restraints and inappropriate regulations.
The agency does not consider it necessary at this time to require
disinfection of bottled water. FDA acknowledges the strict standards
for bottling water that have been adopted by the European Community and
by other countries, and that, when water from protected sources is
bottled under strict hygienic conditions, disinfection may not be
necessary. However, the agency has established microbiological quality
standards in Sec. 165.110(b)(2), and bottled water that does not comply
with the microbiological quality standard must be labeled with a
statement of substandard quality, in accordance with
Sec. 165.110(c)(1). In addition, any bottled water containing a
substance at a level considered injurious to health is deemed to be
adulterated regardless of whether or not the label bears a statement of
substandard quality. FDA has authority to take regulatory action
against such product under section 402(a)(1) of the act.
Under the SDWA, EPA monitors drinking water and establishes
regulations to protect the public from the adverse health effects of
contaminants in public drinking water. FDA's microbiological standard,
like other bottled water standards, follows EPA's requirements for
drinking water. Thus, even though the microbiological standard was
established for quality purposes and not safety, FDA concludes that it
is adequate to protect the public health. The agency points out that
should EPA require disinfection of drinking water, FDA will consider
mandatory disinfection of bottled water.
F. Laboratory and Personnel Approval
IBWA requested that the CGMP regulations be revised to include
requirements for certification of laboratories that analyze water and
of supervisory personnel. The agency stated in the proposal that the
act did not provide authority to the agency to require such approval,
and that even if such authority were provided by the act, the agency
lacked the resources to monitor analytical laboratories and personnel
in the absence of a significant public health problem. Under
Sec. 129.35(a)(3)(iii), analysis of samples may be performed for the
plant by competent commercial laboratories. The agency did not receive
comments concerning laboratory personnel.
111. A number of comments urged FDA to require the use of certified
laboratories to test bottled water. Comments stated that laboratories
performing analyses should be validated in some manner to ensure their
competency, although FDA need not be the validator. One comment stated
that the public is better and more consistently protected by requiring
that certified laboratories conduct the required analyses.
One comment stated that the compliance of bottled water with
quality standards is directly related to the competence and reliability
of the laboratories that perform the analysis for contaminants. It
stated that it is not clear what FDA means by ``competent commercial
laboratories.'' It asked, concerning the criteria that would be used to
determine whether a laboratory is competent, who would determine
whether a laboratory meets these criteria, and how would a bottler be
able to determine that a laboratory is able to provide valid test
results. The comment stated that the term ``competent'' is too vague
and will not promote uniformity. Another comment stated that the use of
uncertified, ``competent'' laboratories provides little assurance that
contaminants, even when present, will be detected.
Comments stated that, because EPA requires that determinations of
compliance with its MCL's be based on data generated by a certified
drinking water laboratory, it would be consistent with the spirit of
the MOU between FDA and EPA for FDA also to require the use of
certified laboratories. The comments stated that FDA would not have to
expend resources because certification programs are in place and
administered by the States, with laboratories bearing the cost. They
added that FDA's adoption of a laboratory certification requirement
would be consistent with its stated intent of incorporating EPA
drinking water analytical methods for determining compliance with
bottled water quality standards.
Comments stated that bottled water laboratory testing certification
is a major problem that must be addressed by FDA. They stated that,
currently, a number of State regulatory agencies require that bottled
water sold in their States be tested in one of their State-certified
laboratories, and that this issue causes undue replication expenses for
multiple State licensing and hinders free interstate commerce.
One comment stated that water bottlers should be encouraged to
perform laboratory tests on site. It stated that transportation to a
certified laboratory can require considerable time and can delay
results. The comment stated that while it is important for a certified
laboratory to serve as a reference, water bottlers would best serve the
public by performing analyses on site.
The agency disagrees that it should require the use of certified
laboratories to test bottled water. Under Sec. 129.35(a)(3)(iii),
analysis of the water samples may be performed for the plant by
competent commercial laboratories. Thus, laboratories used to analyze
bottled water must be competent whether or not they have been certified
competent. A competent laboratory is one that is capable of performing
the required analyses and of obtaining valid and accurate results from
its analyses. Any laboratory that has been certified by EPA or a State
to test drinking water is deemed to be a competent laboratory. EPA- and
State-certified laboratories may be used for comparative purposes
against other commercial laboratories or a plant's own laboratory. To
clarify that the agency believes that EPA- and State-certified
laboratories are appropriate to perform water analyses to demonstrate
compliance with parts 129 and 165, FDA is amending
Sec. 129.35(a)(3)(iii) to specifically cite EPA- and State-certified
laboratories as examples of competent laboratories. Failure to have
been certified will not preclude a laboratory from being considered
competent, but the existence of such certification will eliminate any
doubt about the laboratory's competency.
FDA agrees with the comment that stated that water bottlers should
be encouraged to perform laboratory tests on site. Manufacturers of
many types of foods effectively perform their own routine laboratory
tests on their products. To the extent possible, bottled water
manufacturers should perform routine tests on bottled water. For
example, testing for microbiological quality must be conducted at least
once a week for source water (Sec. 129.35(a)(3)), as often as necessary
for product water (Sec. 129.80(a)), and at least once a week
[[Page 57117]]
for the finished product (Sec. 129.80(g)(1)). Manufacturers can obtain
quick, reliable results using their own laboratories versus the time it
would take to send the samples to a commercial laboratory. However,
firms must ensure the competency of their labs.
The comments have not convinced the agency that the public health
will be better protected by requiring the use of certified
laboratories. Regardless of the laboratory used for testing, water
containing any substance at a level considered injurious to health is
deemed to be adulterated (see section 402(a)(1) of the act and
Sec. 165.110(d)). Thus, the agency concludes that the public health is
already protected.
The MOU between FDA and EPA delineates jurisdiction over types of
drinking water but does not consider the issue of certified
laboratories. Although FDA incorporates EPA methods into the quality
standard, FDA has yet to be convinced that only EPA- or State-certified
laboratories are capable of using EPA methods.
In response to the comment concerning States requiring additional
testing in laboratories certified in their own States, the agency
points out that regardless of whether it required the use of certified
labs, the CGMP regulations are not preemptive and does not preclude
States from establishing stricter requirements for bottled water sold
in their States.
G. Annual Plant Inspection
IBWA requested that FDA revise the CGMP regulations to include a
requirement for annual plant inspections to ensure compliance with the
regulations. FDA stated in the January 1993, proposal that without a
clear indication of a significant public health problem that could not
be corrected by other means, there is no basis for FDA to adopt such a
requirement for bottled water. FDA recognized, however, that IBWA
requires third party inspection of its member firms, and FDA encourages
such self-regulated programs within industry.
112. A number of comments stated that FDA did not provide
sufficient rationale for not imposing annual plant inspection
requirements on the growing bottled water industry. Several comments
stated that annual inspections would reduce the likelihood that
bottlers would be out of compliance for extended periods of time. One
comment stated that, irrespective of who performs the inspection, FDA
should require inspections at least biannually for bottled water
plants. It added that FDA could contract with State regulatory agencies
to accomplish these inspections.
Some comments encouraged FDA to consider third party inspections
because third party inspections would ensure compliance with the
regulations without requiring FDA to increase resource requirements.
One comment urged FDA to modify Sec. 129.80(g) to include a requirement
for annual inspections by a qualified third party organization because
it would address expressed State government concerns. It stated that
some State governments require that companies submit a report issued by
a recognized organization that inspects bottled water systems for
compliance with part 129 (i.e., NSF International or other
organization, State, or country with an inspection protocol as
stringent as NSF's).
The agency disagrees with the comments and affirms that, in the
absence of a significant public health problem, the hazards from
bottled water do not warrant this requirement.
The monitoring/inspectional aspect of FDA's program is carried out
by its field force. The agency monitors and inspects bottled water
products and processing plants as part of its compliance programs for
foods. There are roughly 30 compliance programs for foods covering the
full range of potential food safety problems, including chemical
contaminants, pesticides, filth, and food additives. About one-half of
the programs are for imported foods. They provide broad guidance to the
field on the agency's inspectional priorities. The agency's work plan
further specifies the number of inspections, sample collections, wharf
exams, analyses, and other activities in each program by district. The
districts have considerable latitude as to the establishments that they
inspect and the products that they examine to allow for adequate
coverage of local problems and regionalized industry.
Bottled water establishments are covered under the general food
safety program. Bottled water plants, along with carbonated beverage
bottling plants and warehouses, generally are assigned low priority for
inspection. Priorities are based on factors such as the potential for a
public health problem and the violation rate of the industry. When
compared to products such as low-acid canned foods and products in
which Listeria or Salmonella have a significant potential to develop,
bottled water products are a relatively low public health problem.
FDA's experience over the years has supported that ranking (Ref.
24). Studies of bottled water products have generally not found
significant problems in these products (id). Consequently, bottled
water plants shipping in interstate commerce are inspected about once
every 4 years, unless the firm is violative. The frequency of
inspection of violative firms is accelerated depending on the number,
significance, and recurrence of violations. Furthermore, the districts
follow up on consumer and trade complaints and other leads, as
appropriate, on potentially violative bottled water products.
FDA also contracts with the States to perform some bottled water
plant inspections. The FDA district offices are generally in contact
with their State counterparts to exchange information about compliance
problems, inspectional coverage, and new food establishments. In
addition to FDA inspection, the State and local governments have their
own inspection and licensing programs. Therefore, FDA concludes that it
need not mandate annual plant inspections for bottled water.
113. One comment suggested that FDA consider establishing specific
criteria for the operation of a bottled water plant to ensure that
there is compliance with CGMP's for bottled water manufacturing. It
stated that it is a lot easier for an inexperienced person to establish
a bottling facility for water, capable of producing high volumes of
product, than it is to start up with other food products. The comment
held that an effective licensing program is needed far more for this
type of product than for other foods and beverages because of a greater
risk to the public.
Another comment suggested that FDA establish for its quality
standards some type of monitoring timeframes along with deadlines for
submission of monitoring results from State-approved drinking water
laboratories.
FDA notes that it has established a CGMP regulation in part 129 for
the processing and bottling of drinking water. Thus, FDA has
established regulations on how to operate a bottled water plant.
Bottled water produced in violation of part 129 is adulterated under
section 402(a)(4) of the act in that the food has been prepared,
packed, or held under unsanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious
to health.
Part 129 requires monitoring of the source water, product water,
and finished product. According to Sec. 129.35(a)(3), samples of source
water must be taken and analyzed at a minimum frequency of once each
year for chemical contaminants and once every 4 years for radiological
[[Page 57118]]
contaminants. Additionally, source water obtained from somewhere other
than a public water system is to be sampled and analyzed for
microbiological contaminants at least once each week. Test and sample
methods must be consistent with the minimum requirements set forth in
Sec. 165.110(b).
Product water samples must be taken after processing and before
bottling, and analyzed as often as is necessary to assure the
uniformity and the effectiveness of the processes performed by the
plant (Sec. 129.80(a)).
The compliance procedures for the finished product are set forth in
Sec. 129.80(g). A firm must test a representative sample of each
product for bacteriological contamination at least once a week. To
ensure chemical, physical, and radiological quality, a manufacturer
must take and analyze at least annually a representative sample of each
product. The finished bottled water must comply with the quality
standard in Sec. 165.110(b).
Plants must retain all records required by part 129 for not less
than 2 years, and these documents must be available for official review
at reasonable times (Sec. 129.80(h)). These records must be available
for FDA plant inspections. The agency notes that it does not have the
resources to review bottled water test results except during FDA plant
inspections.
Thus, while FDA has not established a licensing requirement for
water bottlers, it has established a regulatory regime to ensure the
safety and quality of bottled water products.
H. Recall Procedures
IBWA requested that FDA establish specific recall procedures for
bottlers and dealers in the CGMP regulations. In the January 1993
proposal FDA found no basis for this requested revision.
114. A number of comments stated that FDA did not provide
sufficient rationale in the proposal for not establishing specific
recall procedures for bottlers and dealers in the growing bottled water
industry.
One comment stated that, although there should not be specific
recall procedures in the regulations, language that requires that a
written recall plan or document be maintained by the bottler should be
included in the FDA regulations. It stated that the existence of such a
plan would ensure a quick response by a bottler in the event that a
recall is necessary.
The agency notes that part 7 (21 CFR part 7), subpart C provides
guidelines on policy, procedures, and industry responsibilities for
recalls. In Sec. 7.59, FDA advises firms to: (1) Prepare and maintain a
current written contingency plan for use in initiating and effecting a
recall; (2) use sufficient coding of regulated products to make
possible positive lot identification and to facilitate effective recall
of all violative lots; and (3) maintain such product distribution
records as are necessary to facilitate locating of products that are
being recalled. Such records should be maintained for a period of time
that exceeds the shelf life and the expected use of the product.
The agency notes that recall is a voluntary action that takes place
because manufacturers and distributors carry out their responsibility
to protect the public health and from products that present risks of
injury or gross deception or are otherwise defective. Recall is an
alternative to an FDA court action for removing distributed products
from interstate commerce.
FDA is not aware of any circumstances that establish that there is
a unique problem with recalls of bottled water. Therefore, FDA
concludes that the guidelines for recall procedures for foods are
adequate. If a firm refuses to undertake a recall that is requested by
FDA, or where FDA has reason to believe that a recall would not be
effective, determines that a recall is ineffective, or discovers that a
violation is continuing, it may initiate seizure, multiple seizure, or
other court action.
V. Other Matters
A. Ozone
The agency proposed to specify in Sec. 184.1563(d) that the term
``bottled water,'' for purposes of this section, does not include
mineral water with TDS greater than 500 ppm. The agency stated that
this action is necessary to ensure that FDA's rulemaking on the
definition of bottled water in Sec. 165.110 does not inadvertently have
the effect of expanding the permitted uses of ozone.
115. Two comments objected to the exclusion of mineral water from
ozonation. One of the comments stated that this exclusion conflicts
with other FDA proposals to include mineral water as a bottled water.
It stated that California has permitted the ozonation of mineral water
for many years, and that ozonation is by far the most common means of
germicidal water treatment that California mineral water firms use.
Another comment stated that there is no known reason to preclude
ozonation as the antimicrobial agent for mineral water with TDS's
greater than 500 ppm, provided that the maximum residual level
requirements are met. It stated that the difference between mineral
water and bottled water is only how much ozonation is required, at what
temperature, and for how long a period of time.
The agency has reconsidered its January 1993, proposal in light of
these comments and of its original decision to affirm the use of ozone
in bottled water as generally recognized as safe (GRAS). In that
decision (47 FR 50209, November 5, 1982), FDA noted its 1968 opinion
that ozone used to disinfect potable water is GRAS if it is used in
accordance with CGMP and with the recommendations of the U.S. Public
Health Service. The only restriction was that the water must be
potable. FDA also noted the continuous use of ozone in Europe for
disinfecting municipal water for nearly 70 years without any evidence
of toxicity. To ensure that the levels of any oxidation products formed
are low and safe, the agency included a requirement in the GRAS
affirmation regulation that the starting water, before ozonation, meet
the microbiological, physical, chemical, and radiological quality
standards for bottled water specified in Sec. 103.35 (b) through (e).
FDA considers this requirement to be a clarification of what it
considered to be CGMP, namely, that ozone would not be used to
disinfect polluted water.
A restriction on the use of ozone in mineral water with TDS greater
than 500 ppm does not specifically address the goal of the proposal
which was to ensure that the level of oxidation products do not exceed
the levels anticipated when the GRAS affirmation regulation was issued.
The oxidation products of concern from the use of ozone that were
considered in establishing the GRAS regulation were those from
dissolved organic material, whereas the increased solids content of
mineral water consists primarily of minerals (inorganic material).
Moreover, the restriction in the GRAS affirmation regulation that the
use of ozone in disinfecting water be in accordance with CGMP means
that only water that meets the new standard in Sec. 165.110(b), which
limits the amount of dissolved organic material that may be present,
will be processed with ozone. Therefore, FDA has decided that there is
no need to include the restriction limiting the TDS to 500 ppm for
mineral water in the GRAS affirmation regulation for ozone.
Of relevance in this regard is the fact that bromate can be formed
when ozone is used on waters that contain sufficient levels of bromide
(a mineral component). EPA has conducted an evaluation of bromate and
classified it as a probable human carcinogen because bromate
administered to rodents in their
[[Page 57119]]
drinking water has been shown to produce several types of tumors in
both sexes. EPA has proposed an MCLG for bromate of zero and an MCL of
10 micrograms (g)/L (59 FR 38668, July 29, 1994). In the event
EPA establishes an MCL for bromate in drinking water, then in
accordance with section 410 of the Act FDA will propose to establish an
allowable level for bromate in bottled water in Sec. 165.110(b). The
agency further emphasizes that water that is treated with ozone that
results in bromate levels that may be injurious to health is
adulterated under section 402(a)(1) of the Act.
B. Nutrition Labeling
116. One comment stated that it was concerned with the level of
sodium that is allowed under the current regulations, while still
allowing the label to claim that the food is ``sodium free'' or ``salt
free.'' It stated that FDA permits the label to claim ``sodium free''
up to 21.1 ppm in bottled water. The comment noted that bottlers who
use ion exchange in their treatment process can actually add sodium to
the bottled water. The comment expressed concern about any regulation
that permits advertising of ``sodium free'' when there actually is
sodium in the bottled water.
The agency discussed this aspect of its ``sodium-free'' regulation
in the Federal Register of January 6, 1993 (58 FR 2302 at 2321) and
stated that it believes that it is appropriate to apply the term
``free'' to a nutrient when a food contains that nutrient in a
dietetically trivial or physiologically inconsequential amount, even
though the nutrient is present at a level at or near its reliable limit
of quantitation. With modern analytical methods, the level at which the
presence of a nutrient may be quantified is becoming increasingly
smaller.
For example, there are almost no foods that can be said to be truly
sodium free, yet the level of sodium present in some foods has no
impact on the diet. The Daily Recommended Value for sodium is 2,400 mg.
Thus, the agency concluded that a food containing less than 5 mg per
reference amount customarily consumed (reference amount) could be
considered sodium free because 5 mg is a dietarily insignificant
fraction of 2,400 mg. The reference amount for bottled water is 240 mL.
Therefore, the claim ``sodium free'' may be used on a bottled water
label if the sodium content is less than 5 mg per 240 mL serving (21
ppm). If a ``sodium free'' claim is made, the bottled water must bear
nutrition labeling in accordance with Sec. 101.9.
The agency points out that although the term ``salt'' is not
synonymous with ``sodium,'' salt refers to sodium chloride. Under
Sec. 101.61(c)(1), the term ``salt free'' may be used on the label or
in labeling of foods only if the food is ``sodium free.''
FDA recognizes that some sodium may be added to water during ion
exchange treatment. The label of the bottled water product treated in
this manner could still qualify to bear the statement ``sodium free''
if the sodium content of the final product is less than 5 mg per 240 mL
serving. However, if the sodium content is 5 mg or greater per 240 mL
serving, the bottled water must bear nutrition labeling and could not
be labeled as ``sodium free.''
117. One comment asked that bottled water have a qualified
exception from the nutrition labeling regulations except when a claim
is made that the water contains a significant level of a nutrient or
nutrients. It stated that in that event, nutrition labeling for the
nutrient for which the claim is made would be required. The comment
stated that, for example, if a bottled water bore a claim of ``no
sodium'' or ``no calories,'' it could be accompanied, on the
information panel, by a statement, ``not a significant source of
________'' with the blank filled in with the items claimed in the
statement. Another comment questioned why the declaration ``sodium
free'' would trigger a nutritional panel for information on fat and
calories when it is common knowledge that water does not contain these
nutrients.
One comment requested that FDA exempt bottled water products other
than mineral water from nutrition labeling. It stated that consumers do
not expect any nutrition from bottled water, except perhaps for some
minerals in mineral water. It suggested that bottled water with less
than 250 ppm TDS (i.e., bottled water that is not mineral water) be
exempted from nutrition labeling, even if fluoride is added. It stated
that label space was a problem.
FDA notes that the requested exemptions and modifications for
nutrition labeling fall outside the scope of this rulemaking. However,
FDA discussed these issues in the final rule on nutrition labeling of
January 6, 1993 (58 FR 2079 at 2149), and stated that:
A recent IOM [Institute of Medicine] report, ``Food Labeling:
Toward National Uniformity'' (Ref. 25), noted that many States have
expressed concern about the heightened potential for consumer
confusion because of the increased number of bottled water products
on the market and the aggressive marketing and advertising claims of
superiority made for them. Thus, FDA maintains its position that
nutrition information relating to food must be provided for all
products, including bottled and mineral water, that contain more
than insignificant amounts of any of the nutrients or food
components that are required to be listed, or whose label, labeling,
or advertising contains a nutrient content claim or any other
nutrition information in any context. For products that qualify for
the simplified format, if manufacturers voluntarily declare
nutrients allowable under Sec. 101.9(c) that are not among the 14
required nutrients (e.g., potassium), the required statement ``Not a
significant source of ________,'' must be used, with the blank
filled in with the name of any of the 14 required nutrients or food
components that are not present or are present in insignificant
amounts. Moreover, if a product is voluntarily enriched or fortified
with added vitamins or minerals, any such nutrients must be declared
using the simplified format and followed by the above statement.
Thus, a product labeled as ``bottled water, minerals added'' will
have to bear nutrition labeling.
* * * * *
Bottled water products containing juice or other flavors are
subject to the same nutrition labeling requirements as any other
food. If a product meets the criteria for no nutritional
significance, and no claims are made, then nutrition labeling is not
required. A ``sodium free'' declaration on bottled water or on any
other food label will trigger nutrition labeling, because such a
claim promotes the nutritional properties of the product.
As discussed previously under comment 92 of this document, if
fluoride is added to bottled water, and the label bears a statement to
indicate this addition, other than in the ingredient statement, the
label must bear nutrition labeling that complies with the simplified
format.
C. Preemption
118. Comments from several States objected to the Federal standards
of identity for bottled water preempting any State standards that are
not identical to it, as some States have established regulations for
bottled water that are more stringent than the FDA standard. One
comment stated that it is a fundamental right of a State to make
regulations and standards that are at least as stringent as or more
stringent than Federal regulations and standards. It contended that
FDA's role is more appropriately to establish Federal rules that will
protect the public health and prevent fraudulent claims from being made
that might mislead consumers of bottled water products. Another State
held that it has made great efforts to ensure that bottled water meets
standards at least as stringent as those set forth in EPA's primary
drinking water regulations.
A number of comments requested that FDA more clearly explain the
scope of
[[Page 57120]]
the preemption provision, and that it specifically address whether the
agency interprets Federal preemption to apply to certain State
requirements (i.e., labeling restrictions, laboratory certification,
and certain testing requirements).
Comments asserted that many State regulations are costly and do not
provide consumers with any more protection than is likely to be
provided by those proposed by FDA. One comment stated that FDA should
emphasize that a given State should not be allowed to place an undue
burden on interstate commerce by requiring that analyses be performed
only in laboratories that are certified by that State, or that analyses
be performed according to an unduly restrictive frequency unrelated to
public health protection. The comment added that regulatory activity by
the States in areas such as standards and environmental protection is
causing difficulties for those seeking to import goods into the United
States.
FDA notes that, under section 403A(a)(1) of the act (21 U.S.C. 343-
1(a)(1)), a State may not establish or continue in effect a standard of
identity for a food that is the subject of a standard of identity under
section 401 of the act if the State standard is not identical to the
Federal standard. Section 403A(a)(1) of the act only effects preemption
with respect to matters on which a Federal requirement exists. If there
is no Federal requirement to be given preemptive effect, preemption
does not occur.
Under Sec. 100.1(c)(4), if the State requirement is identical to
the Federal law, there is no issue of preemption. In addition, if the
State requirement does the same thing that the Federal law does, even
if the words are not exactly the same, then it is effectively the same
requirement as the Federal requirement. FDA's view, as embodied in
Sec. 100.1(c)(4), is that such a State or local requirement is
consistent with the Federal requirement. Therefore, the only State
requirements that are subject to preemption are those that are
affirmatively different from the Federal requirements on matters that
are covered by section 403A(a) of the act.
FDA acknowledges that some stringent State laws will be preempted
by less restrictive Federal regulations. However, one of the goals of
the national uniformity provisions of the 1990 amendments was to give
industry some relief from some types of State requirements that
interfere with their ability to market products in all 50 States in an
efficient and cost-effective manner (Statement of Rep. Madigan, 136
Congressional Record H12954 (October 26, 1990)). Thus, in enacting the
1990 amendments, Congress apparently decided that even though Federal
requirements may preempt more restrictive State requirements in certain
instances, the net benefits from national uniformity in these aspects
outweigh the loss in consumer protection that may occur as a result.
The agency notes that certain State laws and regulations will not
be preempted because FDA's requirements have not been given preemptive
effect. Therefore, a State will not be precluded from enforcing its
provisions in such circumstances. The agency points out, for example,
that FDA has not sought to give preemptive effect to part 129.
Therefore, if a State has stricter requirements than those in part 129,
the State standard is not preempted by the Federal requirement.
The agency advises that, in those instances where a State
requirement is preempted and the State believes that there are
significant protections of the public that will be lost as a result,
the State may petition the agency to modify the standard in question.
FDA intends to give careful consideration to any such petitions that it
receives.
119. Some comments contended that many States have bottlers whose
products do not cross State lines, thereby avoiding compliance with FDA
regulations. They suggested that the regulation should include all
bottlers regardless of intrastate/interstate sales.
One comment from a State contended that by proposing to apply these
standards only to interstate manufacturers, FDA establishes an undue
logistical burden on regulatory agencies, as they would have to
establish two levels of regulation. The comment argued that more
consistent regulation is possible by applying the same standards to all
bottled water firms that desire to sell their products in a particular
State.
The agency advises that the act only applies to food that is in, or
is intended to be shipped in, interstate commerce. Sections 301 and 304
of the act (21 U.S.C. 331 and 334) specifically describe prohibited
acts and liability for seizure of food that is held for sale in, is in,
or has been shipped in interstate commerce. FDA encourages States to
apply the Federal standard to both interstate and intrastate commerce
to eliminate two levels of regulation and to avoid undue logistical
burdens.
VI. Conclusions
After review and consideration of the comments received in response
to the January 1993 proposal, FDA concludes that it should amend part
129 and establish part 165 as set forth in the proposal but with the
specific modifications to the proposed regulation discussed in this
document. For the purposes of this final rule, certain changes, in
addition to those discussed in this document, were made for editorial
purposes, clarity, and consistency only. These changes do not modify
any matter of substance.
VII. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the proposed rule (58 FR 393, January 5,
1993). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
VIII. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). According to Executive
Order 12866, a regulatory action is ``economically significant'' if it
meets any one of a number of specified conditions, including having an
annual effect on the economy of $100 million or adversely affect in a
material way a sector of the economy, competition, or jobs. A
regulation is considered ``significant'' under Executive Order 12866 if
it raises novel legal or policy issues.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. In compliance with the Regulatory Flexibility Act,
the agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities. Therefore,
under the Regulatory Flexibility Act, no further analysis is required.
In the economic assessment to the proposal in this rulemaking (58
FR 393), FDA considered the costs and benefits of taking this action.
FDA estimated compliance costs to be between $18 million and $21
million and benefits to be approximately $35 million plus the value of
any increase in interstate
[[Page 57121]]
commerce that might occur because of the elimination of conflicting
State regulations. Thus, benefits were estimated to exceed costs by
from $14 million to $17 million, plus the value of any increase in
interstate commerce in bottled water.
The comments to the proposal discussed three issues relevant to the
economic assessment. The first issue involves the ability of the
product definitions adopted in this final rule to communicate
information about bottled water products to consumers. The second issue
involves the cost of label changes. The third issue involves the
economic consequences of the definitions and labeling requirements
adopted in this final rule for particular bottled water manufacturers.
A. Ability of Definitions To Communicate Information to Consumers
Some comments suggested or provided data indicating that some of
the definitions for particular types of bottled water adopted in this
final rule may not correspond to some consumers' current ideas about
the essential features of various types of bottled water. The
implication of these comments is that the definitions adopted in this
final rule will generate confusion over the characteristics of these
products.
Although FDA acknowledges that some of the definitions may not
correspond to some consumers' current ideas about the essential
features of some types of bottled water, this phenomenon does not
necessarily imply that confusion over these products will be increased
by this final rule. In States in which these products are not currently
defined, the terms currently used to refer to various bottled water
products may also not correspond to some consumers' current ideas about
the essential features of those types of bottled water. Similarly, in
States in which these products are already defined, the State
definitions may also not correspond to some consumers' current ideas
about the essential features of those types of bottled water.
Other comments suggested that alternative definitions could be
adopted that would be more consistent with most consumers' current
ideas about the essential features of various types of bottled water
than the definitions adopted in this final rule. These comments imply
confusion will be greater under the definitions adopted in this final
rule than under the alternative definitions. Similarly, some comments
suggested definitions already adopted by particular States are more
consistent with consumers' current ideas about the essential features
of various types of bottled water than the definitions adopted in this
final rule. These comments imply confusion will be increased if
existing state definitions are superseded by the definitions adopted in
this final rule.
For example, a number of comments suggested that most consumers
believe ``spring water'' must be extracted from the natural orifice of
a spring and not from a bore hole. This final rule defines ``spring
water'' to include water extracted from both the natural orifice of a
spring and from a bore hole tapping the underground formation feeding
the spring. The comments imply the definition of ``spring water''
adopted in this final rule will generate greater confusion over the
characteristics of this product than would a definition specifying that
``spring water'' be extracted from the natural orifice of a spring. As
discussed in the preamble to this document, FDA believes that these
comments are in error, and that most consumers do not believe ``spring
water'' must be extracted from the natural orifice of a spring.
Another comment discussed the results of a survey in which the
majority of respondents thought ``artesian well water'' flowed to the
surface due to natural pressure. In contrast, the geological definition
of an artesian well does not imply water from this type of well flows
to the surface due to natural pressure. The definition of ``artesian
well water'' adopted in this final rule is consistent with the
geological definition of an artesian well and does not require that
this type of water flow to the surface due to natural pressure. The
comment suggested the definition adopted in this final rule will create
more confusion over the characteristics of this product than would a
definition specifying that ``artesian well water'' flows to the surface
due to natural pressure.
FDA acknowledges that many consumers may be unaware of the
geological definition of an ``artesian well,'' and that, in the short
run, the definition of ``artesian well water'' adopted in this final
rule may lead some consumers to be confused over the characteristics of
this product. However, in the long run, this confusion will be less
than the confusion that would be generated if FDA failed to adopt a
definition for this term or adopted a definition that failed to
correspond to the accepted geological definition of an artesian well.
Adopting a standardized definition for this term will increase the
ability of interested consumers to interpret this term. Adopting a
standardized definition consistent with accepted geological terminology
will increase the ability of interested consumers to attain information
on this type of water.
Comments also discussed a number of other elements of the
definitions adopted in this final rule. These comments are addressed in
the preamble to this document. These comments do not provide sufficient
information to establish that alternative definitions would be more
consistent with most consumers' current ideas about the essential
features of various types of bottled water than the definitions adopted
in this final rule.
B. The Cost of Label Changes
Comments provided a wide range of estimates of the cost of
relabeling bottled water products to conform to the proposed
definitions and labeling requirements. One comment suggested label
changes will cost $2,000 per product, per location, not including the
cost of the actual label. Another comment suggested the cost of each
label plate change alone will be $200. Another comment suggested it
will cost a single firm ``hundreds of thousands of dollars'' to change
their labels.
In the economic assessment of the proposal in this rulemaking, FDA
used an average relabeling cost of $45,000 per label change. This cost
estimate was based on information previously provided by a bottled
water manufacturer. Although the comments suggest the cost of
relabeling may be highly variable across firms, and that the cost of
relabeling may be lower than $45,000 per label for many firms, the
comments do not provide sufficient information to determine an
appropriate adjustment in the average cost of relabeling.
Some comments implied that changes in advertising would also be
required to accommodate the product definitions established under this
final rule. In the economic assessment to the proposal in this
rulemaking, FDA did not consider these costs because FDA believed the
proposed definitions were sufficiently broad that no firm legally
selling a given type of bottled water would be unable to do so because
of the proposed regulation.
One comment suggested 44 brands of bottled water currently marketed
as mineral water in the United States would no longer be able to be
marketed as mineral water under this final rule. However, the only
brands listed in this comment were Mountain Valley, Volvic, and Poland
Spring. Based on the information available to the agency, this comment
is in error. It appears that no
[[Page 57122]]
mineral water is actually being marketed under these brand names.
Another comment suggested most of the mineral water sold in the
world, including the U.S. market, is produced in Europe, and that these
products currently exhibit a wide range of total dissolved solids (TDS)
levels, from under 100 mg/L to over 1,000 mg/L. The implication of this
comment is that some mineral water produced in Europe with less than
250 ppm TDS is currently being marketed as mineral water in the United
States and would no longer be able to be marketed as mineral water
under this final rule. However, this comment did not identify any
European brands that would actually be affected in this manner, and FDA
is not aware of any such brands.
FDA, therefore, has no information that this final rule will
require extensive modification of existing advertising.
C. Economic Consequences of Definitions and Other Labeling Requirements
on Particular Bottled Water Manufacturers
A number of comments suggested that the definitions and the
labeling requirements in this final rule will have a negative impact on
the sales of some bottled water products and thus a negative impact on
some bottled water manufacturers.
Two comments suggested that some water currently sold as mineral
water would no longer be able to be sold as mineral water under this
final rule, and that this would have a negative impact on the sales of
those products. This issue is different from the advertising cost
issue, which is the context in which these same comments were discussed
in the preceding section. However, FDA's response to these comments is
the same in this context as in the context of advertising costs. FDA is
not aware of any brand of mineral water that will no longer be able to
be marketed as mineral water under this final rule.
Another comment noted the definition of ``bottled water'' does not
allow for the addition of ingredients such as minerals for flavor,
sodium fluoride, flavors which comprise less than one percent by
weight, and carbon dioxide. According to this comment, many products
currently sold simply as ``bottled water'' contain these ingredients,
and that by causing these products to be labeled differently, this
final rule will generate a tremendous adverse economic impact on the
firms producing these products. FDA believes this comment is in error
because it is currently illegal to sell water containing these
ingredients as simply ``bottled water,'' and FDA is not aware of any
products that are labeled in this manner.
Another comment suggested that if drinking water is not recognized
by FDA as a specific type of bottled water, severe economic
repercussions would occur for companies that currently sell bottled
drinking water. This final rule does not define ``drinking water'' as a
specific type of bottled water, although it does allow for the use of
the term ``drinking water'' as a synonym for ``bottled water.''
However, this comment provided no information to support the claim that
consumers believe drinking water is a specific type of bottled water.
In addition, nearly all bottled water sold in the United States meets
the conditions suggested in this comment as being peculiar to drinking
water. Therefore, FDA does not believe the sales of drinking water will
be significantly affected by this final rule.
Another comment suggested that the additional labeling requirements
for bottled water marketed for use in infant formula will cause a
negative impact on the sales of these products and will effectively
destroy this product line. However, the comment provided no information
to support this claim. Therefore, there is no basis for FDA to take any
action in reliance on this comment.
D. Conclusions
The economic assessment to the proposal in this rulemaking (58 FR
393) estimated net benefits of $14 million to $17 million plus the
value of any increase in interstate commerce that might occur because
of the elimination of conflicting State regulations.
The previous economic assessment did not consider the potential
effect of the definitions and labeling requirements on the level of
consumer confusion over bottled water products. Accounting for this
effect will probably increase estimated net benefits. However, FDA has
insufficient information to estimate this increase in net benefits.
In addition, the definitions and labeling requirements adopted in
this final rule may result in a decrease in the sales of some products
and an increase in the sales of other products. However, FDA has
insufficient information to determine the size or significance of these
effects.
Therefore, FDA estimates that the benefits of this final rule will
exceed the costs by $14 million to $17 million, plus the value of any
increase in interstate commerce which might occur because of the
elimination of conflicting State regulations and the value of any
reduction in consumer confusion over these products.
IX. Effective Date
FDA proposed that any final rule that was issued based upon the
proposal would become effective 180 days following issuance of the
final rule.
120. One comment asked FDA to consider the cost and phase- in
considerations for bottled water companies whose main business involves
3-, 5-, or 6-gallon reusable polycarbonate silk-screened bottles. The
comment stated that these bottles, which are generally recycled when no
longer fit for use, cost approximately $4 to $5 each and have a normal
life span of 5 to 7 years, although they can last 10 years or longer.
It stated that a company with about $6 million in sales has an
inventory of about 200,000 bottles or a bottle investment of $800,000
to $1,000,000. The comment maintained that any change in labeling
requirements has major potential expense implications for bottlers
using 3-, 5-, or 6-gallon polycarbonate silk screened bottles. It held
that any relabeling of these bottles with adhesive labels can be costly
and presents potential problems in the washing process. It asked that
consideration be given to extended phase-in periods for reusable
bottles where a change in labels is required because of the new
regulations.
Under section 403(g) of the act, a food is deemed to be misbranded
if it purports to be, or is represented as, a food for which a
definition and standard of identity has been prescribed by regulation
unless it conforms to such definition and standard, and its label bears
the name of the food specified in the definition and standard. Thus,
all bottled water labels must bear appropriate labeling in conformance
with an effective standard of identity.
FDA recognizes that some bottled water labels will have to be
modified to comply with the standard of identity for bottled water,
even though the definitions are based on current meanings of terms. The
agency has provided for additional nomenclature (e.g., ``drinking
water'') in this final rule, and as a result, many label changes that
the comment may have anticipated will not be required.
However, FDA realizes that it may be a hardship for some firms to
make required label changes on reusable polycarbonate silk-screened
bottles because these bottles are used for years before replacement,
and replacement of an entire stock would be burdensome by the effective
date of this final rule. Therefore, the agency is allowing an
[[Page 57123]]
alternative means of compliance whereby the labeling information
required by the standard of identity that is otherwise required on
reusable polycarbonate silk- screened bottles may be placed on the
customer invoice or bill of lading that is provided with each delivery.
This alternative means of compliance is provided in lieu of having the
labeling information required by the standard of identity permanently
affixed to an existing bottle as otherwise required by section 201(k)
of the act. This alternative means of compliance only applies to
information on the polycarbonate silk-screened bottles and does not
apply to information on the bottle cap.
The special labeling provision is provided for currently existing
containers. As a firm replaces the polycarbonate silk-screened bottles
presently in use with new ones, the required information must be
permanently affixed to the new bottles. To fulfill the intent of the
act, all labeling on the invoice or bill of lading must be in
compliance with FDA requirements. The agency notes that this
alternative means of compliance is consistent with that established for
nutrition labeling under Sec. 101.9(g)(9).
X. References
The following information has been placed on display in the Dockets
Management Branch (address above), and may be seen by interested
persons between 9 a.m. and 4 p.m. Monday through Friday.
1. Codex Alimentarius, vol. XII, ``Codex Standards for Natural
Mineral Waters and Edible Ices and Ice Mixes,'' Food and Agriculture
Organization of the United Nations, World Health Organization, Rome,
1982.
2. State of California, Chapter 639, Assembly Bill No. 170,
September 15, 1987.
3. ``The Surgeon General's Report on Nutrition and Health,''
DHHS, Public Health Service Publication No. 88-50210 (Government
Printing Office Stock No. 017-001-00465-1), U.S. Government Printing
Office, Washington, DC, 1988.
4. Barness, Lewis A., Nutrition and Oral Health, ``Pediatric
Nutrition Handbook,'' 3d Ed., American Academy of Pediatrics, Elk
Grove Village, IL, 1993.
5. Heath, R.C., United States Geological Survey, ``Basic Ground-
Water Hydrology,'' Water-Supply Paper 2220, United States Government
Printing Office, 1989.
6. The United States Pharmacopeia, 23d Revision, United States
Pharmacopeial Convention, Inc., Rockville, MD, 1995.
7. Association of Food and Drug Officials, ``AFDO Model Bottled
Water Regulation,'' 1986.
8. Davis, S.A., memorandum to file, ``A Comparison of
Definitions for Mineral Water,'' May 11, 1995.
9. Freeze, R.A. and J.A. Cherry, ``Groundwater,'' Prentice-Hall
Inc., 1979.
10. Sax, N.I., and R.J. Lewis, Sr., ``Hawley's Condensed
Chemical Dictionary,'' Van Nostrand Reinhold Company, 1987.
11. Florida Department of Agriculture and Consumer Services,
Bottled Water Plant/Dealer Application Information, July 23, 1992.
12. Sowards, R.D., Texas Department of Health, letter to Janice
F. Oliver, July 30, 1991.
13. Guralnik, David B., ``Webster's New World Dictionary of the
American Language,'' Warner Books, Inc., 1983.
14. Mississippi State Board of Health, ``Regulations Governing
Bottled Water,'' December 1991.
15. International Bottled Water Association, Model Bottled Water
Regulation, January 24, 1991.
16. O'Donnell, W.J., ``Sanpellegrino,'' Proceedings of the
Bottled Water Workshop, A Report Prepared for the Use of the
Subcommittee on Energy and Commerce, U.S. House of Representatives,
U.S. Government Printing Office, Washington, DC, 1990.
17. The Council of the European Communities, ``Council Directive
of 15 July, 1980 on the Approximation of the Laws of the Member
States Relating to the Exploitation and Marketing of Natural Mineral
Waters,'' Official Journal of the European Communities, No. L. 229/
1, 1980.
18. Lathrop, Donald B., ``Bacteriological Counts on Infant
Formulas Mixed in the Home,'' Archives of Pediatrics, 73:451, 1956.
19. Ducluzeau, R., S. Dufresne, and J.M. Bochand, ``Inoculation
of the Digestive Tract of Axenic Mice with the Autochthonous
Bacteria of Mineral Water,'' European Journal of Applied
Microbiology, 2:127, 1976.
20. ``Guidelines for Drinking-Water Quality,'' vol. 1, d. ed.,
World Health Organization, 1993.
21. Mottram, V.H., ``Human Nutrition,'' Edward Arnold
Publishers, Ltd., 1963.
22. Allen, H.E., M.A. Halley-Henderson, C.N. Hass, ``Chemical
Composition of Bottled Mineral Water,'' Archives of Environmental
Health, vol. 44 (No. 2), p. 102, March/April 1989.
23. Vasconcelos, J. and S. Harris, ``Consensus Method for
Determining Groundwaters Under the Direct Influence of Surface Water
Using Microscopic Particulate Analysis,'' USEPA Manchester
Environmental Laboratory, Port Orchard, WA, October 1992.
24. Troxell, T., ``Role of the FDA in Regulating Bottled
Water,'' Proceedings of the Bottled Water Workshop, A Report
Prepared for the Use of the Subcommittee on Energy and Commerce,
U.S. House of Representatives, U.S. Government Printing Office,
Washington, DC, 1990.
25. Committee on State Food Labeling, Food and Nutrition Board,
Institute of Medicine, National Academy of Sciences, ``Food
Labeling: Toward National Uniformity,'' National Academy Press,
Washington DC, 1992.
List of Subjects
21 CFR Part 103
Beverages, Bottled water, Food grades and standards.
21 CFR Part 129
Beverages, Bottled water, Food packaging, Reporting and
recordkeeping requirements.
21 CFR Part 165
Beverages, Bottled water, Food grades and standards, Incorporation
by reference.
21 CFR Part 184
Food ingredients.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR
Chapter I is amended as follows:
PART 103--QUALITY STANDARDS FOR FOODS WITH NO IDENTITY STANDARDS
1. The authority citation for 21 CFR part 103 continues to read as
follows:
Authority: Secs. 201, 401, 403, 409, 410, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348,
349, 371, 379e).
Subpart B--[Reserved]
2. Subpart B, consisting of Sec. 103.35 Bottled water, is removed
and reserved.
PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
3. The authority citation for 21 CFR part 129 continues to read as
follows:
Authority: Secs. 402, 409, 701, 704 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 342, 348, 371, 374); sec. 361 of the
Public Health Service Act (42 U.S.C. 264).
4. Section 129.35 is amended by revising paragraphs (a)(3)(ii) and
(a)(3)(iii) and by adding new paragraph (a)(4) to read as follows:
Sec. 129.35 Sanitary facilities.
* * * * *
(a) * * *
(3) * * *
(ii) Test and sample methods shall be those recognized and approved
by the government agency or agencies having jurisdiction over the
approval of the water source, and shall be consistent with the minimum
requirements set forth in Sec. 165.110(b) of this chapter.
(iii) Analysis of the sample may be performed for the plant by
competent commercial laboratories (e.g., Environmental Protection
Agency (EPA) and State-certified laboratories).
[[Page 57124]]
(4) Source water testing exemptions. (i) Firms that use a public
water system for source water may substitute public water system
testing results, or certificates showing full compliance with all
provisions of EPA National Primary and Secondary Drinking Water
Regulations pertaining to chemical contaminants (40 CFR parts 141 and
143), for the testing requirements of Sec. 129.35(a)(3).
(ii) Firms that do not use a public water system as the source of
their water may reduce the frequency of their testing of that source,
as well as the number of chemical contaminants for which they test the
source water, if they can document that such reduction is consistent
with a State-issued waiver under EPA regulations (40 CFR parts 141 and
143).
(iii) The finished bottled water must comply with bottled water
quality standards (21 CFR 165.110(b)) and section 402(a)(1) of the act
dealing with adulterated foods.
* * * * *
5. Section 129.80 is amended by revising the introductory text of
paragraph (g) to read as follows:
Sec. 129.80 Processes and controls.
* * * * *
(g) Compliance procedures. A quality standard for bottled drinking
water is established in Sec. 165.110(b) of this chapter. To assure that
the plant's production of bottled drinking water complies with the
applicable standards, laws, and regulations of the government agency or
agencies having jurisdiction, the plant will analyze product samples as
follows:
* * * * *
6. New part 165 is added to read as follows:
PART 165--BEVERAGES
Subpart A--General Provisions
Sec.
165.3 Definitions.
Subpart B--Requirements for Specific Standardized Beverages
165.110 Bottled water.
Authority: Secs. 201, 401, 403, 403A, 409, 410, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 343A,
348, 349, 371, 379e).
Subpart A--General Provisions
Sec. 165.3 Definitions.
(a) A lot is:
(1) For purposes of determining quality factors related to
manufacture, processing, or packing, a collection of primary containers
or units of the same size, type, and style produced under conditions as
nearly uniform as possible and usually designated by a common container
code or marking, or in the absence of any common container code or
marking, a day's production.
(2) For purposes of determining quality factors related to
distribution and storage, a collection of primary containers or units
transported, stored, or held under conditions as nearly uniform as
possible.
(b) A sample consists of 10 subsamples (consumer units), one taken
from each of 10 different randomly chosen shipping cases to be
representative of a given lot, unless otherwise specified in a specific
standard in this part.
(c) An analytical unit is the portion(s) of food taken from a
subsample of a sample for the purpose of analysis.
Subpart B--Requirements for Specific Standardized Beverages
Sec. 165.110 Bottled water.
(a) Identity--(1) Description. Bottled water is water that is
intended for human consumption and that is sealed in bottles or other
containers with no added ingredients except that it may optionally
contain safe and suitable antimicrobial agents. Fluoride may be
optionally added within the limitations established in
Sec. 165.110(b)(4)(ii). Bottled water may be used as an ingredient in
beverages (e.g., diluted juices, flavored bottled waters). It does not
include those food ingredients that are declared in ingredient labeling
as ``water,'' ``carbonated water,'' ``disinfected water,'' ``filtered
water,'' ``seltzer water,'' ``soda water,'' ``sparkling water,'' and
``tonic water.'' The processing and bottling of bottled water shall
comply with applicable regulations in part 129 of this chapter.
(2) Nomenclature. The name of the food is ``bottled water,''
``drinking water,'' or alternatively one or more of the following terms
as appropriate:
(i) The name of water from a well tapping a confined aquifer in
which the water level stands at some height above the top of the
aquifer is ``artesian water'' or ``artesian well water.'' Artesian
water may be collected with the assistance of external force to enhance
the natural underground pressure. On request, plants shall demonstrate
to appropriate regulatory officials that the water level stands at some
height above the top of the aquifer.
(ii) The name of water from a subsurface saturated zone that is
under a pressure equal to or greater than atmospheric pressure is
``ground water.'' Ground water must not be under the direct influence
of surface water as defined in 40 CFR 141.2.
(iii) The name of water containing not less than 250 parts per
million (ppm) total dissolved solids (TDS), coming from a source tapped
at one or more bore holes or springs, originating from a geologically
and physically protected underground water source, may be ``mineral
water.'' Mineral water shall be distinguished from other types of water
by its constant level and relative proportions of minerals and trace
elements at the point of emergence from the source, due account being
taken of the cycles of natural fluctuations. No minerals may be added
to this water.
(iv) The name of water that has been produced by distillation,
deionization, reverse osmosis, or other suitable processes and that
meets the definition of ``purified water'' in the United States
Pharmacopeia, 23d Revision, January 1, 1995, which is incorporated by
reference in accordance with 5 U.S.C. 551(a) and 1 CFR part 51. (Copies
may be obtained from the United States Pharmacopial Convention, Inc.,
12601 Twinbrook Pkwy., Rockville, MD 20852 and may be examined at the
Center for Food Safety and Applied Nutrition, 200 C St. SW.,
Washington, DC, or at the Office of the Federal Register, 800 North
Capitol St. NW., suite 700, Washington, DC), may be ``purified water''
or ``demineralized water.'' Alternatively, the water may be called
``deionized water'' if the water has been processed by deionization,
``distilled water'' if it is produced by distillation, ``reverse
osmosis water'' if the water has been processed by reverse osmosis, and
``__________ drinking water'' with the blank being filled in with one
of the defined terms describing the water in this paragraph (e.g.,
``purified drinking water'' or ``deionized drinking water'').
(v) The name of water that, after treatment and possible
replacement of carbon dioxide, contains the same amount of carbon
dioxide that it had at emergence from the source may be ``sparkling
bottled water.''
(vi) The name of water derived from an underground formation from
which water flows naturally to the surface of the earth may be ``spring
water.'' Spring water shall be collected only at the spring or through
a bore hole tapping the underground formation feeding the spring. There
shall be a natural force causing the water to flow to the surface
through a natural orifice. The location of the spring shall be
identified. Spring water collected with the use of an external force
shall be from the same underground stratum as the spring, as shown by a
measurable hydraulic connection using a hydrogeologically
[[Page 57125]]
valid method between the bore hole and the natural spring, and shall
have all the physical properties, before treatment, and be of the same
composition and quality, as the water that flows naturally to the
surface of the earth. If spring water is collected with the use of an
external force, water must continue to flow naturally to the surface of
the earth through the spring's natural orifice. Plants shall
demonstrate, on request, to appropriate regulatory officials, using a
hydrogeologically valid method, that an appropriate hydraulic
connection exists between the natural orifice of the spring and the
bore hole.
(vii) The name of water that meets the requirements under
``Sterility Tests'' <71> in the United States Pharmacopeia, 23d
Revision, January 1, 1995, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR 51. (Copies may be obtained
from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook
Pkwy., Rockville, MD 20852 and may be examined at the Center for Food
Safety and Applied Nutrition, 200 C St. SW., Washington, DC, or at the
Office of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC), may be ``sterile water.'' Alternatively, the water may
be called ``sterilized water.''
(viii) The name of water from a hole bored, drilled, or otherwise
constructed in the ground which taps the water of an aquifer may be
``well water.''
(3) Other label statements. (i) If the TDS content of mineral water
is below 500 ppm, or if it is greater than 1,500 ppm, the statement
``low mineral content'' or the statement ``high mineral content'',
respectively, shall appear on the principal display panel following the
statement of identity in type size at least one-half the size of the
statement of identity but in no case of less than one-sixteenth of an
inch. If the TDS of mineral water is between 500 and 1,500 ppm, no
additional statement need appear.
(ii) When bottled water comes from a community water system, as
defined in 40 CFR 141.2, except when it has been treated to meet the
definitions in paragraphs (a)(2)(iv) and (a)(2)(vii) of this section
and is labeled as such, the label shall state ``from a community water
system'' or, alternatively, ``from a municipal source'' as appropriate,
on the principal display panel or panels. This statement shall
immediately and conspicuously precede or follow the name of the food
without intervening written, printed, or graphic matter, other than
statements required by paragraph (c) of this section, in type size at
least one-half the size of the statement of identity but in no case of
less than one-sixteenth of an inch.
(iii) When the label or labeling of a bottled water product states
or implies (e.g., through label statements or vignettes with references
to infants) that the bottled water is for use in feeding infants, and
the product is not commercially sterile under Sec. 113.3(e)(3)(i) of
this chapter, the product's label shall bear conspicuously and on the
principal display panel the statement ``Not sterile. Use as directed by
physician or by labeling directions for use of infant formula.''
(4) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections
of parts 101 and 130 of this chapter.
(b) Quality. The standard of quality for bottled water, including
water for use as an ingredient in beverages (except those described in
the labeling as ``water,'' ``carbonated water,'' ``disinfected water,''
``filtered water,'' ``seltzer water,'' ``soda water,'' ``sparkling
water,'' and ``tonic water''), is as follows:
(1) Definitions. (i) Trihalomethane (THM) means one of the family
of organic compounds, named as derivatives of methane, wherein three of
the four hydrogen atoms in methane are each substituted by a halogen
atom in the molecular structure.
(ii) Total trihalomethane (TTHM) means the sum of the concentration
in milligrams per liter of the trihalomethane compounds
(trichloromethane, dibromochloromethane, bromodichloromethane and
tribromomethane), rounded to two significant figures.
(2) Microbiological quality. Bottled water shall, when a sample
consisting of analytical units of equal volume is examined by the
methods described in applicable sections of ``Standard Methods for the
Examination of Water and Wastewater,'' 15th Ed. (1980), American Public
Health Association, which is incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51 (copies may be obtained from the
American Public Health Association, 1015 15th St., NW., Washington, DC
20005, or a copy may be examined at the Office of the Federal Register,
800 North Capitol St., NW., suite 700, Washington, DC, or at the Center
for Food Safety and Applied Nutrition, 200 C St., SW., Washington, DC),
meet the following standards of microbiological quality:
(i) Multiple-tube fermentation method. Not more than one of the
analytical units in the sample shall have a most probable number (MPN)
of 2.2 or more coliform organisms per 100 milliliters and no analytical
unit shall have an MPN of 9.2 or more coliform organisms per 100
milliliters; or
(ii) Membrane filter method. Not more than one of the analytical
units in the sample shall have 4.0 or more coliform organisms per 100
milliliters and the arithmetic mean of the coliform density of the
sample shall not exceed one coliform organism per 100 milliliters.
(3) Physical quality. Bottled water shall, when a composite of
analytical units of equal volume from a sample is examined by the
method described in applicable sections of ``Standard Methods for the
Examination of Water and Wastewater,'' 15th Ed. (1980), which is
incorporated by reference (the availability of this incorporation by
reference is given in paragraph (b)(2) of this section), meet the
following standards of physical quality:
(i) The turbidity shall not exceed 5 units.
(ii) The color shall not exceed 15 units.\1\
(iii) The odor shall not exceed threshold odor No. 3.\1\
(4) Chemical quality. (i)(A) Bottled water shall, when a composite
of analytical units of equal volume from a sample is examined by the
methods described in paragraph (b)(4)(i)(B) of this section, meet
standards of chemical quality and shall not contain chemical substances
in excess of the following concentrations:
------------------------------------------------------------------------
Concentration in
Substance milligrams per
liter
------------------------------------------------------------------------
Arsenic............................................... 0.05
Chloride\1\........................................... 250.0
Iron\1\............................................... 0.3
Manganese\1\.......................................... 0.05
Phenols............................................... 0.001
Sulfate\1\............................................ 250.0
Total dissolved solids\1\............................. 500.0
Zinc \1\.............................................. 5.0
Organics:
Endrin (1,2,3,4,10,10-hexachloro-6,7-epoxy 1, 4, 4a,
5, 6, 7, 8, 8a-octa-hydro-1,4-endo, endo-5,8-
dimethane naphthalene)............................. 0.0002
Total Trihalomethanes............................. 0.10
------------------------------------------------------------------------
\1\ Mineral water is exempt from allowable level. The exemptions are
aesthetically based allowable levels and do not relate to a health
concern.
(B) Analyses conducted to determine compliance with paragraph
(b)(4)(i)(A) of this section shall be made in accordance with the
methods described in the applicable sections of ``Standard Methods for
the Examination of Water
[[Page 57126]]
and Wastewater,'' 15th Ed. (1980), or ``Methods for Chemical Analysis
of Water and Wastes,'' Environmental Monitoring and Support Laboratory
(EMSL), EPA-600/4-79-020, March 1983, U.S. Environmental Protection
Agency (EPA), both of which are incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51.
(C) Analyses for organic substances shall be determined by the
appropriate methods set forth below. The methods in paragraphs
(b)(4)(i)(C)(1) and (C)(2) of this section are incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and are
described in ``Standard Methods for Examination of Water and
Wastewater,'' 15th Ed. (1980). Copies may be obtained from the American
Public Health Association, 1015 Fifteenth St., NW., Washington DC
20005, and examined at the Office of the Federal Register, 800 North
Capitol St., NW., suite 700, Washington DC, or the Center for Food
Safety and Applied Nutrition, 200 C St. NW., Washington DC. The methods
in paragraphs (b)(4)(i)(C)(3) and (C)(4) are cross-referenced in 40 CFR
part 141, subpart C, Appendix C.
(1) ``Methods for Organochlorine Pesticides in Industrial
Effluents;''
(2) ``Methods for Chlorinated Phenoxy Acid Herbicides in Industrial
Effluents,'' November 28, 1973;
(3) ``Part I: The Analysis of Trihalomethanes in Finished Waters by
the Purge and Trap Method;'' which is cross-referenced in 40 CFR part
141, subpart C, appendix C;
(4) ``Part II: The Analysis of Trihalomethanes in Drinking Water by
Liquid/Liquid Extraction,'' Method 501.2 which is cross-referenced in
40 CFR part 141, subpart C, appendix C;
(ii)(A) Bottled water packaged in the United States to which no
fluoride is added shall not contain fluoride in excess of the levels in
Table 1 and these levels shall be based on the annual average of
maximum daily air temperatures at the location where the bottled water
is sold at retail.
Table 1
------------------------------------------------------------------------
Fluoride
Annual average of maximum daily air temperatures ( concentration in
deg.F) milligrams per
liter
------------------------------------------------------------------------
53.7 and below........................................ 2.4
53.8-58.3............................................. 2.2
58.4-63.8............................................. 2.0
63.9-70.6............................................. 1.8
70.7-79.2............................................. 1.6
79.3-90.5............................................. 1.4
------------------------------------------------------------------------
(B) Imported bottled water to which no fluoride is added shall not
contain fluoride in excess of 1.4 milligrams per liter.
(C) Bottled water packaged in the United States to which fluoride
is added shall not contain fluoride in excess of levels in Table 2 and
these levels shall be based on the annual average of maximum daily air
temperatures at the location where the bottled water is sold at retail.
Table 2
------------------------------------------------------------------------
Fluoride
Annual average of maximum daily air temperatures ( concentration in
deg.F) milligrams per
liter
------------------------------------------------------------------------
53.7 and below........................................ 1.7
53.8-58.3............................................. 1.5
58.4-63.8............................................. 1.3
63.9-70.6............................................. 1.2
70.7-79.2............................................. 1.0
79.3-90.5............................................. 0.8
------------------------------------------------------------------------
(D) Imported bottled water to which fluoride is added shall not
contain fluoride in excess of 0.8 milligram per liter.
(iii) Having consulted with EPA as required by section 410 of the
Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration
has determined that bottled water, when a composite of analytical units
of equal volume from a sample is examined by the methods listed in
paragraphs (b)(4)(iii)(E) through (b)(4)(iii)(F), and (b)(4)(iii)(G) of
this section, shall not contain the following chemical contaminants in
excess of the concentrations specified in paragraphs (b)(4)(iii)(A)
through (b)(4)(iii)(D) of this section.
(A) The allowable levels for inorganic substances are as follows:
------------------------------------------------------------------------
Concentration in milligrams
Contaminant per liter (or as specified)
------------------------------------------------------------------------
Barium.................................... 2.
Cadmium................................... 0.005.
Chromium.................................. 0.1.
Copper.................................... 1.0.
Lead...................................... 0.005.
Mercury................................... 0.002.
Nitrate................................... 10 (as nitrogen).
Nitrite................................... 1 (as nitrogen).
Total Nitrate and Nitrite............. 10 (as nitrogen).
Selenium.................................. 0.05.
------------------------------------------------------------------------
(B) The allowable levels for volatile organic chemicals (VOC's) are
as follows:
------------------------------------------------------------------------
Concentration in
Contaminant (CAS Reg. No.) milligrams per
liter
------------------------------------------------------------------------
Benzene (71-43-2).................................... 0.005
Carbon tetrachloride (56-23-5)....................... 0.005
o-Dichlorobenzene (95-50-1).......................... 0.6
p-Dichlorobenzene (106-46-7)......................... 0.075
1,2-Dichloroethane (107-06-2)........................ 0.005
1,1-Dichloroethylene (75-35-4)....................... 0.007
cis-1,2-Dichloroethylene (156-59-2).................. 0.07
trans-1,2-Dichloroethylene (156-60-5)................ 0.1
1,2-Dichloropropane (78-87-5)........................ 0.005
Ethylbenzene (100-41-4).............................. 0.7
Monochlorobenzene (108-90-7)......................... 0.1
Styrene (100-42-5)................................... 0.1
Tetrachloroethylene (127-18-4)....................... 0.005
Toluene (108-88-3)................................... 1
1,1,1-Trichloroethane (71-55-6)...................... 0.20
Trichloroethylene (79-01-6).......................... 0.005
Vinyl chloride (75-01-4)............................. 0.002
Xylenes (1330-20-7).................................. 10
------------------------------------------------------------------------
(C) The allowable levels for pesticides and other synthetic organic
chemicals (SOC's) are as follows:
------------------------------------------------------------------------
Concentration in
Contaminant (CAS Reg. No.) milligrams per
liter
------------------------------------------------------------------------
Alachlor (15972-60-8)................................. 0.002
Atrazine (1912-24-9).................................. 0.003
Carbofuran (1563-66-2)................................ 0.04
Chlordane (57-74-9)................................... 0.002
1,2-Dibromo-3-chloropropane (96-12-8)................. 0.0002
2,4-D (94-75-7)....................................... 0.07
Ethylene dibromide (106-93-4)......................... 0.00005
Heptachlor (76-44-8).................................. 0.0004
Heptachlor epoxide (1024-57-3)........................ 0.0002
Lindane (58-89-9)..................................... 0.0002
Methoxychlor (72-43-5)................................ 0.04
Pentachlorophenol (87-86-5)........................... 0.001
PCB's (as decachlorobiphenyl) (1336-36-3)............. 0.0005
Toxaphene (8001-35-2)................................. 0.003
2,4,5-TP (Silvex) (93-72-1)........................... 0.05
------------------------------------------------------------------------
(D) The allowable levels for certain chemicals for which EPA has
established secondary maximum contaminant levels in its drinking water
regulations (40 CFR part 143) are as follows:
[[Page 57127]]
------------------------------------------------------------------------
Concentration in
Contaminant milligrams per
liter
------------------------------------------------------------------------
Aluminum.............................................. 0.2
Silver................................................ 0.1
------------------------------------------------------------------------
(E) Analyses to determine compliance with the requirements of
paragraph (b)(4)(iii)(A) of this section shall be conducted in
accordance with an applicable method and applicable revisions to the
methods listed in paragraphs (b)(4)(iii)(E)(1) through
(b)(4)(iii)(E)(13) of this section and described, unless otherwise
noted, in ``Methods for Chemical Analysis of Water and Wastes,'' U.S.
EPA, Environmental Monitoring and Support Laboratory (EPA-600/4-79-
020), March 1983, which is incorporated by reference in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are
available from the National Technical Information Service, U.S.
Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or
may be examined at the Office of Plant and Dairy Foods and Beverages
(HFS-305), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St., SW., Washington, DC, or at the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(1) [Reserved]
(2) Barium shall be measured using the following methods:
(i) Method 208.2--``Atomic Absorption; furnace technique,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51, or
(ii) Method 208.1--``Atomic Absorption; direct aspiration,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. The availability of this incorporation by reference is
given in paragraph (b)(4)(iii)(A) of this section.
(iii) Method 200.7--``Determination of Metals and Trace Elements in
Water and Wastes by Inductively Coupled Plasma-Atomic Emission
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in the
manual entitled ``Methods for the Determination of Metals in
Environmental Samples,'' Office of Research and Development,
Washington, DC 20460, (EPA/600/4-91/010), June 1991, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies of this publication are available from the National
Technical Information Service, U.S. Department of Commerce, 5825 Port
Royal Rd., Springfield, VA 22161, or may be examined at the Office of
Plant and Dairy Foods and Beverages (HFS-305), Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 200 C St., SW.,
Washington, DC, or at the Office of the Federal Register, 800 North
Capitol St. NW., suite 700, Washington, DC.
(3) [Reserved]
(4) Cadmium shall be measured using the following methods:
(i) Method 213.2--``Atomic Absorption; furnace technique,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. The availability of this incorporation by reference is
given in paragraph (b)(4)(iii)(E) of this section.
(ii) Method 200.7--``Determination of Metals and Trace Elements in
Water and Wastes by Inductively Coupled Plasma-Atomic Emission
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in the
manual entitled ``Methods for the Determination of Metals in
Environmental Samples,'' Office of Research and Development,(EPA/600/4-
91/010), June 1991, which is incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this
incorporation by reference is given in paragraph (b)(4)(iii)(E)(2)(iii)
of this section.
(5) Chromium shall be measured using the following methods:
(i) Method 218.2--``Atomic Absorption; furnace technique,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. The availability of this incorporation by reference is
given in paragraph (b)(4)(iii)(E) of this section.
(ii) Method 200.7--``Determination of Metals and Trace Elements in
Water and Wastes by Inductively Coupled Plasma-Atomic Emission
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in the
manual entitled ``Methods for the Determination of Metals in
Environmental Samples,'' Office of Research and Development, (EPA/600/
4-91/010), June 1991, which is incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this
incorporation by reference is given in paragraph (b)(4)(iii)(E)(1)(iii)
of this section.
(6) Copper shall be measured as total recoverable metal without
filtration using the following methods:
(i) Method 220.2--Atomic Absorption; furnace technique, in
``Methods for Chemical Analysis of Water and Wastes,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51, or
(ii) Method 220.1--Atomic Absorption; direct aspiration, in
``Methods for Chemical Analysis of Water and Wastes,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given
in paragraph (b)(4)(iii)(E) of this section.
(iii) Method 200.7--``Determination of Metals and Trace Elements in
Water and Wastes by Inductively Coupled Plasma-Atomic Emission
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in the
manual entitled ``Methods for the Determination of Metals in
Environmental Samples,'' Office of Research and Development, (EPA/600/
4-91/010), June 1991, which is incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are
available from the National Technical Information Service, U.S.
Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or
may be examined at the Office of Plant and Dairy Foods and Beverages
(HFS-305), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, or at the Office
of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
(iv) Method 200.8--``Determination of Trace Elements in Water and
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4,
April 1991. The revision is contained in the manual entitled ``Methods
for the Determination of Metals in Environmental Samples,'' June 1991,
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. The availability of this incorporation by reference
is given in paragraph (b)(4)(iii)(E)(7)(iii) of this section.
(v) Method 200.9--``Determination of Trace Elements by Stabilized
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Revision
1.2, April 1991. The revision is contained in the manual entitled
``Methods for the Determination of Metals in Environmental Samples,''
June 1991, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation
by reference is given in paragraph (b)(4)(iii)(E)(2)(iii) of this
section.
(7) [Reserved]
(8) Lead shall be measured as total recoverable metal without
filtration using the following methods:
(i) Method 239.2--Atomic Absorption; furnace technique, in
``Methods for Chemical Analysis of Water and Wastes,'' which is
incorporated by reference in accordance
[[Page 57128]]
with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this
incorporation by reference is given in paragraph (b)(4)(iii)(E)(2)(iii)
of this section.
(ii) Method 200.8--``Determination of Trace Elements in Water and
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Revision 4.4,
April 1991. The revision is contained in the manual entitled ``Methods
for the Determination of Metals in Environmental Samples,'' June 1991,
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. The availability of this incorporation by reference
is given in paragraph (b)(4)(iii)(E)(7)(iii) of this section.
(iii) Method 200.9--``Determination of Trace Elements by Stabilized
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev.
1.2, April 1991. The revision is contained in the manual entitled
``Methods for the Determination of Metals in Environmental Samples,''
June 1991, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation
by reference is given in paragraph (b)(4)(iii)(E)(2)(iii) of this
section.
(9) Mercury shall be measured using the following methods:
(i) Method 245.1--``Manual cold vapor technique,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51, or
(ii) Method 245.2--``Automated cold vapor technique,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given
in paragraph (b)(4)(iii)(E) of this section.
(10) [Reserved]
(11) Nitrate and/or nitrite shall be measured using the following
methods:
(i) Method 353.3--``Spectrophotometric cadmium reduction,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51, or
(ii) Method 353.2--``Colorimetric, automated, cadmium reduction,''
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51.
(iii) Method 300.0--``The Determination of Inorganic Anions in
Water by Ion chromatography,'' which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this
publication are available from the National Technical Information
Service, Port Royal Rd., Springfield, VA 22161, or may be examined at
the Office of Plant and Dairy Foods and Beverages (HFS-305), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 200 C
St. SW., Washington, DC.
(iv) Method 353.1--``Colorimetric, automated, hydrazine
reduction,'' which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation
by reference is given in paragraph (b)(4)(iii)(E) of this section.
(12) Selenium shall be measured using the following methods:
(i) Method 270.2--``Atomic Absorption; furnace technique,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51, or
(ii) Method 270.3--``Atomic Absorption; gaseous hydride,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given
in paragraph (b)(4)(iii)(E) of this section.
(13) [Reserved]
(F) Analyses to determine compliance with the requirements of
paragraphs (b)(4)(iii)(B) and (b)(4)(iii)(C) of this section shall be
conducted in accordance with an applicable method or applicable
revisions to the methods listed in paragraphs (b)(4)(iii)(F)(1) through
(b)(4)(iii)(F)(20) of this section and described, unless otherwise
noted, in ``Methods for the Determination of Organic Compounds in
Drinking Water,'' Office of Research and Development, Environmental
Monitoring Systems Laboratory EPA/600/4-88/039, December 1988, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies of this publication are available from the National
Technical Information Service, U.S. Department of Commerce, 5285 Port
Royal Rd., Springfield, VA 22161, or may be examined at the Office of
Plant and Dairy Foods and Beverages (HFS-305), Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 200 C St. SW.,
Washington, DC, or at the Office of the Federal Register, 800 North
Capitol St. NW., suite 700, Washington, DC.
(1) Method 502.1--``Volatile Halogenated Organic Compounds in Water
by Purge and Trap Gas Chromatography,'' Rev. 2.0, 1989, (applicable to
VOC's), which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51, or
(2) Method 502.2--``Volatile Organic Compounds in Water by Purge
and Trap Capillary Column Gas Chromatography with Photoionization and
Electrolytic Conductivity Detectors in Series,'' Rev. 2.0, 1989
(applicable to VOC's), which is incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51, or
(3) Method 503.1--``Volatile Aromatic and Unsaturated Organic
Compounds in Water by Purge and Trap Gas Chromatography,'' Rev. 2.0,
1989 (applicable to VOC's), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(4) Method 524.1--``Measurement of Purgeable Organic Compounds in
Water by Packed Column Gas Chromatography/Mass Spectrometry,'' Rev.
3.0, 1989 (applicable to VOC's), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(5) Method 524.2--``Measurement of Purgeable Organic Compounds in
Water by Capillary Column Gas Chromatography/Mass Spectrometry,'' Rev.
3.0, 1989 (applicable to VOC's), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(6) Method 504--``1,2-Dibromoethane (EDB) and 1,2-Dibromo-3-
Chloropropane (DBCP) in Water by Microextraction and Gas
Chromatography,'' Rev. 2.0, 1989 (applicable to dibromochloropropane
(DBCP) and ethylene dibromide (EDB)), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(7) Method 505--``Analysis of Organohalide Pesticides and
Commercial Polychlorinated Biphenyl (PCB) Products in Water by Micro-
Extraction and Gas Chromatography,'' Rev. 2.0, 1989 (applicable to
alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, lindane,
methoxychlor, toxaphene and as a screen for polychlorinated biphenyl's
(PCB's)), which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51, or
(8) [Reserved]
(9) Method 507--``Determination of Nitrogen- and Phosphorus-
Containing Pesticides in Water by Gas Chromatography with a Nitrogen-
Phosphorus Detector,'' Rev. 2.0, 1989 (applicable to alachlor and
atrazine), which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51, or
(10) Method 508--``Determination of Chlorinated Pesticides in Water
by Gas Chromatography with an Electron Capture Detector,'' Rev. 3.0,
1989 (applicable to chlordane, heptachlor, heptachlor epoxide, lindane,
methoxychlor, toxaphene, and as a screen for PCB's), which is
incorporated
[[Page 57129]]
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(11) Method 508A--``Screening for Polychlorinated Biphenyls by
Perchlorination and Gas Chromatography,'' Rev. 1.0, 1989 (used to
quantitate PCB's as decachlorobiphenyl if detected in methods 505 or
508) in paragraph (b)(4)(iii)(F)(7) or (b)(4)(iii)(F)(9) of this
section, respectively), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(12) Method 515.1--``Determination of Chlorinated Acids in Water by
Gas Chromatography with an Electron Capture Detector,'' Rev. 5.0, May
1991 (applicable to 2,4-D, 2,4,5-TP (Silvex) and pentachlorophenol),
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51, or
(13) Method 525.1--``Determination of Organic Compounds in Drinking
Water by Liquid-Solid Extraction and Capillary Column Gas
Chromatography/Mass Spectrometry,'' Rev. 2.2, May 1991 (applicable to
alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, lindane,
methoxychlor, and pentachlorophenol), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(14) Method 531.1--``Measurement of N-Methylcarbamoyloximes and N-
Methylcarbamates in Water by Direct Aqueous Injection HPLC with Post
Column Derivatization,'' Rev. 3.0, 1989 (applicable to carbofuran),
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. The availability of this incorporation by reference
is given in paragraph (b)(4)(iii)(F) of this section.
(15) [Reserved]
(G) Analyses to determine compliance with the requirements of
paragraph (b)(4)(iii)(D) of this section shall be conducted in
accordance with an applicable method and applicable revisions to the
methods listed in paragraphs (b)(4)(iii)(G)(1) and (b)(4)(iii)(G)(2) of
this section and described, unless otherwise noted, in ``Methods of
Chemical Analysis of Water and Wastes,'' which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The
availability of this incorporation by reference is given in paragraph
(b)(4)(iii)(E) of this section.
(1) Aluminum shall be measured using the following methods:
(i) Method 202.1--``Atomic Absorption; direct aspiration
technique,'' which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51.
(ii) Method 202.2--``Atomic Absorption; furnace technique,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. The availability of this incorporation by reference is
given in paragraph (b)(4)(iii)(E) of this section.
(iii) Method 200.7--``Determination of Metals and Trace Elements in
Water and Wastes by Inductively Coupled Plasma-Atomic Emission
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in
``Methods for the Determination of Metals in Environmental Samples,''
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. The availability of the incorporation by reference
is given in paragraph (b)(4)(iii)(E)(2)(iii) of this section.
(iv) Method 200.8--``Determination of Trace Elements in Waters and
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4,
April 1991. The revision is contained in ``Methods for the
Determination of Metals in Environmental Samples,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given
in paragraph (b)(4)(iii)(E)(1)(iii) of this section.
(v) Method 200.9--``Determination of Trace Elements by Stabilized
Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' Rev.
1.2, April 1991. The revision is contained in ``Methods for the
Determination of Metals in Environmental Samples,'' June 1991, which is
incorporated by reference in accordance with 5. U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given
in paragraph (b)(4)(iii)(E)(7)(iii) of this section.
(2) Silver shall be measured using the following methods:
(i) Method 272.1--``Atomic Absorption, direct aspiration,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51, or
(ii) Method 272.2--``Atomic Absorption, furnace technique,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. The availability of this incorporation by reference is
given in paragraph (b)(4)(iii)(E) of this section.
(iii) Method 200.7--``Determination of Metals and Trace Elements in
Water and Wastes by Inductively Coupled Plasma-Atomic Emission
Spectrometry,'' Rev. 3.3, April 1991. The revision is contained in
``Methods for the Determination of Metals in Environmental Samples,''
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. The availability of this incorporation by reference
is given in paragraph (b)(4)(iii)(E)(1)(iii) of this section.
(iv) Method 200.8--``Determination of Trace Elements in Waters and
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 4.4,
April 1991. The revision is contained in ``Methods for the
Determination of Metals in Environmental Samples,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given
in paragraph (b)(4)(iii)(E)(1)(iii) of this section.
(v) Method 200.9--``Determination of Trace Elements by Stabilized
Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' Rev.
1.2, April 1991, in ``Methods for the Determination of Metals in
Environmental Samples,'' which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of
this incorporation by reference is given in paragraph
(b)(4)(iii)(E)(1)(iii) of this section.
(3) and (4) [Reserved]
(5) Radiological quality. (i) Bottled water shall, when a composite
of analytical units of equal volume from a sample is examined by the
methods described in paragraph (b)(5)(ii) of this section, meet
standards of radiological quality as follows:
(A) The bottled water shall not contain a combined radium-226 and
radium-228 activity in excess of 5 picocuries per liter of water.
(B) The bottled water shall not contain a gross alpha particle
activity (including radium-226, but excluding radon and uranium) in
excess of 15 picocuries per liter of water.
(C) The bottled water shall not contain beta particle and photon
radioactivity from manmade radionuclides in excess of that which would
produce an annual dose equivalent to the total body or any internal
organ of 4 millirems per year calculated on the basis of an intake of 2
liters of the water per day. If two or more beta or photon-emitting
radionuclides are present, the sum of their annual dose equivalent to
the total body or to any internal organ shall not exceed 4 millirems
per year.
(ii) Analyses conducted to determine compliance with paragraph
(b)(5)(i) of this section shall be made in accordance with the methods
described in the applicable sections of ``Standard Methods for the
Examination of Water and Wastewater,'' 15th Ed. (1980), and ``Interim
Radiochemical Methodology for Drinking Water,'' U.S. EPA, EMSL,
[[Page 57130]]
EPA-600/4-75-008 (Revised), March 1976, both of which are incorporated
by reference. The availability of these incorporations by reference is
given in paragraph (b)(2) of this section.
(c) Label statements. When the microbiological, physical, chemical,
or radiological quality of bottled water is below that prescribed by
paragraphs (b)(2) through (b)(5), of this section, the label shall bear
the statement of substandard quality specified in Sec. 130.14(a) of
this chapter except that, as appropriate, instead of or in addition to
the statement specified in Sec. 130.14(a) the following statement(s)
shall be used:
(1) ``Contains Excessive Bacteria'' if the bottled water fails to
meet the requirements of paragraph (b)(2) of this section.
(2) ``Excessively Turbid'', ``Abnormal Color'', and/or ``Abnormal
Odor'' if the bottled water fails to meet the requirements of paragraph
(b)(3) (i), (ii), or (iii), respectively, of this section.
(3) ``Contains Excessive ________,'' with the blank filled in with
the name of the chemical for which a maximum contaminant level in
paragraph (b)(4) of this section is exceeded (e.g., ``Contains
Excessive Arsenic,'' ``Contains Excessive Trihalomethanes'') except
that ``Contains Excessive Chemical Substances'' may be used if the
bottled water is not mineral water.
(4) ``Excessively Radioactive'' if the bottled water fails to meet
the requirements of paragraph (b)(5) of this section.
(d) Adulteration. Bottled water containing a substance at a level
considered injurious to health under section 402(a)(1) of the act is
deemed to be adulterated, regardless of whether or not the water bears
a label statement of substandard quality prescribed by paragraph (c) of
this section.
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
AS SAFE
7. The authority citation for 21 CFR part 184 continues to read as
follows:
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
8. Section 184.1563 is amended by revising paragraph (c) to read as
follows:
Sec. 184.1563 Ozone.
* * * * *
(c) In accordance with Sec. 184.1(b)(2), the ingredient is used to
treat food only within the following specific limitations:
------------------------------------------------------------------------
Maximum treatment
Category of food level in food Functional use
------------------------------------------------------------------------
Bottled water that prior to Not to exceed Antimicrobial agent,
ozonation meets the current good Sec. 170.3 (o)(2)
microbiological, physical, manufacturing of this chapter.
chemical, and radiological practice. Current
quality standards of Sec. good manufacturing
165.110 (b)(2) through practice results in
(b)(5) of this chapter. a maximum residual
level at the time
of bottling of 0.4
milligram of ozone
per liter of
bottled water.
------------------------------------------------------------------------
Dated: November 3, 1995.
William K. Hubbard,
Acting Duputy Commissioner for Policy.
[FR Doc. 95-27798 Filed 11-7-95; 8:45 am]
BILLING CODE 4160-01-P
