[Federal Register Volume 65, Number 166 (Friday, August 25, 2000)]
[Notices]
[Pages 51833-51839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21757]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0436]


Food and Drug Administration Final Study Report; Feasibility of 
Appropriate Methods of Informing Customers of the Contents of Bottled 
Water

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing its final 
study report on the feasibility of appropriate methods of informing 
customers of the contents of bottled water, as required by the Safe 
Drinking Water Act (SDWA) Amendments. This final feasibility study 
report evaluates and identifies appropriate methods that may be 
feasible for conveying information about bottled water to customers.

FOR FURTHER INFORMATION CONTACT: Rebecca J. Buckner, Center for Food 
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4081.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 6, 1996, the President signed into law the SDWA 
Amendments (Public Law 104-182). Under the Public Notification section 
of the SDWA Amendments (section 114), the

[[Page 51834]]

Environmental Protection Agency (EPA) was required to issue regulations 
mandating that each community water system mail to each customer of the 
system an annual report, referred to as a consumer confidence report 
(CCR), on the level of contaminants in the drinking water purveyed by 
that system. A complete description of the information contained in a 
CCR can be found in section II.A of this document.
    In the Federal Register of February 13, 1998 (63 FR 7606), EPA 
published a proposed rule to require local water systems to provide an 
annual CCR to their customers. Based on that proposal, EPA published a 
final rule on August 19, 1998 (63 FR 44511). Section 114(b) of the SDWA 
Amendments required that, no more than 18 months after the date of its 
enactment, FDA, in consultation with EPA, publish for notice and 
comment a draft study on the feasibility of appropriate methods, if 
any, of informing customers of the contents of bottled water. Section 
114(b) of the SDWA Amendments also required us to publish a final study 
not later than 30 months after enactment of the SDWA Amendments.
    In the Federal Register of November 12, 1997 (62 FR 60721) 
(hereinafter referred to as the 1997 notice), we published a notice 
requesting comment on several matters relevant to the feasibility of 
appropriate methods of informing customers of the contents of bottled 
water. In the Federal Register of February 22, 2000 (65 FR 8718), we 
published a draft feasibility study report (the draft study). In the 
draft study we evaluated the information received and identified 
appropriate methods that may be feasible for conveying information 
about bottled water to customers. In the draft study, we stated that 
comments received on the draft study would be evaluated and considered 
in preparation of the final report. Interested persons were given until 
April 24, 2000, to comment on the draft study. We received over 250 
letters, each containing one or more comments, from government 
agencies, States, consumer groups, and members of the public in 
response to the draft study. We have evaluated those comments in 
preparing this final feasibility study report.

II. Response to Comments

A. Congressional Mandate for Us Under Section 114(b) of the SDWA 
Amendments

    (Comment 1) Several comments maintained that Congress, because of 
the mandate to us to publish a study on the feasibility of appropriate 
methods, if any, of informing customers of the contents of bottled 
water, intended for us to engage in rulemaking on feasible methods, if 
found.
    We disagree with these comments. The plain language in section 
114(b) of the SDWA Amendments states that we ``shall publish for public 
notice and comment a draft study'' and ``shall publish a final study * 
* *.'' Thus, our charge under the SDWA Amendments is to publish a draft 
and final study on the feasibility of appropriate methods, if any, of 
informing customers of the contents of bottled water. There is no 
language in section 114(b) of the SDWA Amendments requiring us to issue 
regulations. On the contrary, Congress did clearly express its intent 
in other sections of the SDWA Amendments where it wanted regulations to 
be issued. For example, section 114(a) of the SDWA Amendments on 
consumer confidence reports, states that EPA ``shall issue regulations 
* * *.'' No such similar intent was expressed in the plain language of 
the statute, under section 114(b). Therefore, section 114(b) of the 
SDWA Amendments does not require us to issue regulations; section 
114(b) requires us to publish a draft and final feasibility study. 
Moreover, the Conference Report on the Safe Drinking Water Act 
Amendments of 1996 (H. Rept. 104-741, at 9701 (1996)) states, ``The 
study is intended to provide information on the feasibility of 
informing customers concerning the contents of bottled water, and is 
not intended to prejudge the question of whether such information 
requirements are necessary.'' The question about whether information 
requirements are necessary is outside the scope of this final 
feasibility study. We plan to consider, based on the findings in the 
final feasibility study, whether to engage in future rulemaking on 
information requirements on the contents of bottled water.
    (Comment 2) A few comments stated that all of the information 
outlined by EPA for inclusion in a CCR should be placed on the label of 
bottled water because consumers have a right to know this information 
at point of purchase.
    A discussion of an individual's right to know certain information 
on bottled water is beyond the scope of this study. The SDWA Amendments 
directed us to study the feasibility of appropriate methods, if any, of 
informing customers of the contents of bottled water, not whether an 
individual has a right to know information on the contents of bottled 
water. To the extent that these comments assert that it is an 
appropriate and feasible method to include all CCR-type information on 
the label of bottled water, we respond to such assertion in comment 8 
of this document.
    (Comment 3) Several comments requested that more information on 
contaminants and their health effects than what is contained in a CCR 
be placed on the labels of bottled water. Conversely, other comments 
maintained that it is not necessary to provide any of the CCR-type 
information on bottled water to customers; the comments further stated 
that bottled water companies already do provide this information 
voluntarily to customers who request it. In addition, several comments 
requested that fluoride and sodium content be provided on labels of 
bottled water. These comments indicated that fluoride information is 
important so that customers and health professionals can determine if 
an individual's fluoride intake is appropriate and information on 
sodium is important for individuals on a low sodium diet.
    A discussion about whether it is necessary to provide, to 
customers, more information than what is contained in a CCR or more 
than what is currently required on the contents of bottled water is 
beyond the scope of this study. The SDWA Amendments directed us to 
study the feasibility of appropriate methods, if any, of informing 
customers of the contents of bottled water, not whether information is 
necessary. Please note that the sodium content of bottled water is 
already required to be declared on the label, consistent with 21 CFR 
101.9(c)(4).

B. Information About the Contents of Bottled Water

    We stated in the draft study that we believe that much of the 
information contained in a CCR is applicable to bottled water (65 FR 
8718 at 8721). We note that a CCR, as outlined by EPA, contains the 
following: (1) Information about the source of drinking water; (2) 
definitions of ``maximum contaminant level'' (MCL), ``maximum 
contaminant level goal'' (MCLG), ``exemption'' and ``variance''; (3) 
the MCL, MCLG, and contaminant level detected in the water for 
regulated contaminants found in the water during the year and, for any 
contaminant detected that violates the MCL during the year, information 
on the health effects that led EPA to regulate that contaminant; (4) 
information on compliance with EPA's National Primary Drinking Water 
Regulations and notice if the system operates under a variance or an 
exemption and the basis on which the variance or exemption was granted; 
(5) information on the levels of unregulated contaminants for which

[[Page 51835]]

monitoring by the system is required (including, for example, levels of 
Cryptosporidium and radon where States determine such levels may be 
found); and (6) a statement that the presence of contaminants in 
drinking water does not necessarily indicate that the drinking water 
poses a health risk, and that more information about contaminants and 
potential health risks can be obtained by calling the EPA hotline.
    In the draft study, we stated that, while much of the information 
contained in a CCR is applicable to bottled water, we recognize that 
certain information contained in a CCR is relevant only to public 
drinking water systems. Such information includes the definition and 
statement of MCLG's and MCL's and information on public drinking water 
systems operating under a variance and other information that is 
relevant only to public drinking water systems regulated by EPA, such 
as information on EPA's drinking water hotline.
    In the draft study, we noted that our intent in the 1997 notice was 
to solicit information that was analogous to that outlined by EPA for 
inclusion in a CCR (see above). Although we recognize that the SDWA 
Amendments provide for States to develop alternative requirements with 
respect to the form and content of a CCR, it was not our intent to 
solicit a broad range of information but rather to limit the discussion 
to information that is analogous to that outlined by EPA for inclusion 
in a CCR.
    (Comment 4) Several comments stated that contaminants should be 
discussed in terms of MCLG's rather than allowable levels for 
contaminants in bottled water. These comments maintained that MCLG's 
are health-based goals for drinking water, unlike EPA's MCL's and FDA's 
allowable levels that are simply based on MCLG's and that are not 
health-based standards. Further, several comments advocated giving 
health effects information for all contaminants that exceed EPA's 
MCLG's.
    In order to respond to this comment, it is important to note that 
EPA establishes MCLG's and MCL's for contaminants in public drinking 
water, while FDA establishes quality standards with allowable levels 
for contaminants and other constituents in bottled water.
    To the extent that these comments suggest that it is an appropriate 
method to discuss contaminants in bottled water as MCLG's rather than 
as our allowable contaminant levels, we do not agree with these 
comments. EPA's MCLG's and MCL's are both health-based standards for 
contaminant levels. Our allowable levels for contaminants and other 
constituents in bottled water are established under a quality standard 
(21 CFR part 165.110), but are based on EPA's MCL's and, therefore, are 
also health-based standards.
    We have already stated that, for the purposes of determining the 
feasibility of appropriate methods of informing customers of the 
contents of bottled water, we intended for the scope of the information 
discussed in this study to be analogous to that outlined by EPA for 
inclusion in a CCR. Public drinking water systems are required, in 
their CCR's, to provide information regarding the health concerns that 
resulted in regulation of a contaminant, when that contaminant exceeds 
a MCL, not a MCLG. The risks from a contaminant that exceeds a MCLG but 
not a MCL or an allowable level is negligible and, therefore, health 
effects information may not be appropriate. Because our allowable 
levels are based on EPA's MCL's, we believe that it would be an 
appropriate method to base any information regarding health concerns 
for contaminants in bottled water on our allowable levels. MCLG and MCL 
are terms defined by EPA for public drinking water and not for bottled 
water. Therefore, we disagree that it is an appropriate method to 
discuss contaminants in terms of MCLG's rather than allowable levels.
    (Comment 5) Several comments requested that EPA's drinking water 
hotline be provided to customers or that we establish a bottled water 
hotline.
    We do not believe that it would be appropriate to direct customers 
to EPA's drinking water hotline for information on bottled water 
because EPA's hotline only provides information on public drinking 
water. However, we agree that an information hotline for general 
information on bottled water would be analogous to CCR-type information 
available for drinking water. In fact, consumers who have questions 
about bottled water can contact us on our food information hotline, 1-
888-SAFEFOOD (1-888-723-3366), and receive information on bottled water 
that is similar to the type of information on drinking water provided 
by EPA on its drinking water hotline.
    (Comment 6) Several comments indicated that, in addition to the 
information contained in a CCR, bottled water information should 
include a mineral profile, hydrogen-ion concentration (pH) and hardness 
measurements, and information on the type of treatment the water has 
received so that immunocompromised individuals can determine whether 
the water has been treated by one of the methods recommended by the 
Centers for Disease Control and Prevention for the elimination of 
Cryptosporidium. Cryptosporidium is a parasite that has caused serious 
waterborne illness outbreaks, particularly among immunocompromised 
individuals, from the consumption of contaminated public drinking 
water. Comments also suggested that a ``date bottled'' statement, a lot 
code, an ``expiration date'' and a ``refrigerate after opening'' 
statement should be provided on the label.
    In the draft study, we noted that our intent in the 1997 notice was 
to solicit information that was analogous to that outlined by EPA for 
inclusion in a CCR (see above). Although we recognize that the SDWA 
Amendments provide for States to develop alternative requirements with 
respect to the form and content of a CCR, it was not our intent to 
solicit a broad range of information but rather to limit the discussion 
to information that is analogous to that outlined by EPA for inclusion 
in a CCR. Therefore, consideration of information that is not within 
the context of the SDWA Amendments (i.e., analogous to information 
outlined by EPA for inclusion in a CCR) is beyond the scope of this 
study and would be considered in any future rulemaking on this subject, 
if undertaken by us.

C. Feasibility of Appropriate Methods of Informing Customers of the 
Contents of Bottled Water

    In the draft study, we evaluated the appropriateness and 
feasibility of six methods of informing customers of the contents of 
bottled water. These methods included information on the label, a phone 
number/address for company contact on the label, a combination of the 
two previous methods (some information on the label, some available 
through company contact), a pamphlet at point of purchase, an 
information package distributed with bulk water deliveries, and the 
Internet.
    (Comment 7) Several comments stated that if it is feasible for 
public drinking water systems to provide their customers with content 
information on an annual basis, then it is feasible for bottled water 
manufacturers to provide their customers with content information on an 
annual basis, regardless of the method.
    We agree that it is feasible for the bottled water industry to 
provide CCR-type information, updated on a yearly basis, to their 
customers, as public drinking water systems are required to

[[Page 51836]]

provide to their customers. However, certain methods may be more 
feasible than others for providing such annual updates. Moreover, we 
note that contaminant information about bottled water that is updated 
annually may not represent the contents of any one individual bottle of 
water but may represent the contaminant history for a specific time 
period.
1. Information on the Label
    In the draft study, we stated that placing information on the label 
is an appropriate method to inform customers about the contents of 
bottled water. However, we questioned the feasibility of placing all of 
the information that is analogous to information contained in a CCR on 
the label of bottled water. We tentatively determined that the amount 
of information contained in a CCR, as outlined by EPA, is considerable 
and, if placed on a bottled water label, would result in label clutter.
    We stated in the draft study that we also have concerns about the 
economic feasibility of placing information on a label that has the 
potential to change on a frequent basis as a result of ongoing 
monitoring that is required under 21 CFR part 129, ``Processing and 
Bottling of Bottled Drinking Water.'' Costs associated with labeling 
changes to accurately report information that changes on a regular 
basis could be an economic hardship to companies. In addition, 
frequently changing information may result in a product label that is 
no longer accurate, due to changing test results, which may misbrand 
the product under section 403 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343). Therefore, we tentatively determined that it is 
not feasible to place on a bottled water label all of the information 
that would be analogous to that contained in a CCR.
    (Comment 8) Comments that addressed the issue of whether it is 
feasible to place all of the bottled water information analogous to 
that contained in a CCR on a bottled water label, with the exception of 
the comments in comment 2 of this document, stated that it is not 
feasible to do so.
    We agree with the comments that stated it is not feasible to 
provide all of the information that is analogous to that contained in a 
CCR on a bottled water label. Such information would be excessive in 
limited label space, particularly on the small, single serving bottles. 
In addition, information that requires frequent changes due to changing 
test results may result in a product label that is no longer accurate, 
which may result in a misbranded product. Costs of frequent label 
changes that are necessary to ensure accurate information on the 
contents of a bottled water product, due to frequently changing 
information, may present an economic hardship to companies. Moreover, 
even annual updates that represent the contaminant history would need 
information to put the history for all such CCR-type information in 
context for the customer and would be excessive in limited label space. 
We believe that other methods discussed below may be more feasible for 
informing customers about the CCR-type information on bottled water.
2. Information Available by Company Contact
    In the draft study, we tentatively determined that a phone number 
or an address on the label directing customers on how to obtain 
information from the company is an appropriate and feasible method of 
providing information to customers. Telephones and mail are available 
to almost all customers. Information provided in this manner can also 
be kept current. It is the least costly method to industry of providing 
information to customers because it does not require frequent label 
changes. Moreover, the startup costs would only apply to a portion of 
the industry since many firms already provide information to customers 
in this manner.
    (Comment 9) Most comments received on the draft study stated that 
making all or some of the CCR-type information on bottled water 
obtainable via a phone number or an address on the label with 
directions to customers on how to obtain information from the company 
is appropriate and feasible. Several comments maintained that the label 
should provide a toll-free number to call for information, while other 
comments stated that a toll-free number would be a financial burden for 
small bottled water manufacturers.
    We agree with these comments that it is both appropriate and 
feasible for water bottlers to provide CCR-type information to 
customers through a phone number or an address on the label directing 
customers on how to obtain information from the company. Determining 
whether the company should provide a toll-free number versus a toll 
number or an address to customers is beyond the scope of this study.
    The comments maintaining that a toll-free number would be an 
economic burden for small bottled water manufacturers provided no 
information to support their assertion. In the draft study, we did not 
find the cost of providing information to customers via a toll-free 
number to be economically prohibitive and are not persuaded by comments 
to alter that finding.
3. Information Available by the Combination Approach
    In the draft study, we tentatively determined that it would be 
appropriate to provide information to bottled water customers by 
placing certain individual pieces of information on the label, while 
making other CCR-type information available to customers through 
contact with the company (i.e., a combination approach). We also stated 
that we believe that this method is feasible as long as the particular 
information that is placed on the label does not require frequent 
changes as a result of ongoing monitoring for contaminants.
    (Comment 10) A few comments advocated providing lists of 
contaminants that exceed MCLG's, our allowable level for the 
contaminant, and health effects for the contaminant on the label or 
lists of all regulated contaminants detected and their allowable levels 
on the label, with all other CCR-type information available through 
company contact. These same comments, that advocated listing 
contaminants on the label, stated that the number of contaminants that 
would need to be listed would be minimal; one comment estimated that 
the number would be less than six, based on anecdotal evidence from 
public drinking water CCR's. Some comments stated that listing 
contaminants on the label would not lead to label clutter because the 
labels could be expanded or an additional label that hangs around the 
neck of the bottle could be used. Other comments that advocated listing 
contaminants on the label did not address label space, but stated that 
it is important that this information be immediately and easily 
available to the customer.
    We do not agree with these comments. Even if the number of 
contaminants to be included is minimal, when this information is 
combined with the additional information (e.g., allowable levels, 
possible sources of the contaminant, and health effects information, if 
necessary) that would be needed to put the contaminant information in 
context for the customer, such information could be excessive in 
limited label space, particularly on the small, single serving bottles. 
We discourage the use of labels that fold out or hang around the neck 
of a bottle. These labels can be easily removed or torn apart before 
purchase or before the product reaches the final consumer, resulting in 
a product that could be misbranded.

[[Page 51837]]

    While we agree that the label is an appropriate method for listing 
certain CCR-type information, as discussed in comment 11 of this 
document, and provides immediate information to customers, we disagree 
that such a method is appropriate and feasible for all CCR-type 
information for the reasons previously stated. In addition, we believe 
that CCR-type information obtained through other methods, for example 
through company contact, also is easily available to customers. 
Comments did not provide information to indicate otherwise.
    (Comment 11) Many comments advocated that one or two pieces of 
information, such as a specific statement of the source of the water 
and any treatment the water received or levels of specific contaminants 
(i.e., fluoride, lead, arsenic, mercury, radioactive compounds), be 
placed on the label, while all other CCR-type information be available 
by contacting the company.
    We agree that placing some pieces of information on the label, 
while other CCR-type information is available by contacting the 
company, is an appropriate and feasible method of informing customers 
of the contents of bottled water. We do not agree that it is feasible 
to place pieces of information on the label that are not consistent 
from product to product and may result in excessive information (i.e., 
contaminant listings that would require considerable additional text to 
place the information in context for the bottled water customer) in 
limited label space.
    (Comment 12) A few comments also contended that updating 
contaminant information yearly on a bottled water label would not be 
burdensome economically to the bottled water industry.
    This comment seems to suggest that updating contaminant information 
yearly on a bottled water label is feasible because it would not create 
an economic burden to the bottled water industry. Whether such a label 
change would create an economic burden would likely depend upon the 
scope and detail of information that would be included as ``contaminant 
information,'' e.g., whether such information includes a listing of 
contaminants, allowable contaminant levels, possible sources of 
contaminants, health effects information, etc. If requiring firms to 
change labels annually in order to update contaminant information 
increased the frequency of scheduled label changes, such label changes 
would result in a greater cost than what would exist in the absence of 
such a requirement. According to a survey of practices in the bottled 
drink industry, the average time between typical label changes is over 
22 months (Research Triangle Institute, ``Compliance Costs of Food 
Labeling Regulations,'' January 1991). Requiring firms to update the 
information on labels every 12 months would increase the frequency of 
label changes and would therefore impose an additional cost on the 
industry. Whether such cost would result in an economic burden may 
depend on how much information needs to be updated.
4. Information in a Pamphlet
    In the draft study, we tentatively concluded that providing CCR-
type information to customers in a pamphlet that is available at retail 
may not be the most feasible method when other methods of conveying 
information are available. Information on bottled water contained in a 
pamphlet would be subject to the same frequent changes that may be 
necessary for label information due to changing test results from 
ongoing monitoring. In addition, there would be practical concerns 
about assuring that the pamphlets were consistently available at point 
of purchase.
    (Comment 13) Comments did not support placement of a pamphlet 
containing CCR-type information about bottled water at the point of 
purchase as an appropriate and feasible method of providing information 
to customers. One comment stated that retailers carrying several brands 
of bottled water might be required to keep a virtual library of bottled 
water pamphlets and the burden of stocking them also would be on the 
retailer.
    We agree with the comments and believe that pamphlets at point of 
purchase are not a feasible method of providing CCR-type information on 
bottled water to customers.
5. Distribution of an Information Package With Bulk Water Deliveries
    In the draft study, we tentatively determined that it would be 
appropriate and feasible for bulk water deliverers to include an 
information package with a bill or deliver it with an invoice. An 
information package could be prepared in response to any changes in 
information about the delivered product, rather than printed in advance 
as labels typically are. The information also could be provided to 
customers by bulk deliverers only in response to customer request. This 
would reduce the chance for customers who are not seeking additional 
information on the contents of bottled water to be confused by 
information that may not be relevant to them or in which they have no 
interest.
    (Comment 14) Many comments indicated that it would be appropriate 
and feasible for bulk water deliverers to provide customers with CCR-
type information on bottled water on a yearly basis. A few comments 
noted that the label of bulk water containers should contain the same 
information as smaller bottles of water and that a package of 
information delivered with a large container of water should not 
substitute for the label.
    We agree with comments that stated that it is both appropriate and 
feasible for bulk water deliverers to provide CCR-type information to 
their customers on a yearly basis. Bulk water deliverers could include 
this information with a bill or invoice. We also note that the labels 
of bulk containers of water are required to carry the same information 
as smaller bottles of water and that information delivered with a large 
container of water would not substitute for the label that is required 
on the product itself.
6. Information Available on the Internet
    In the draft study, we tentatively determined that it may not be 
appropriate for the Internet to be the sole source of information on 
the contents of bottled water for customers, because not all customers 
have access to it. According to the 1999 Economic Report of the 
President (Washington, DC, 1999), approximately 70 million Americans 
(26 percent of the U.S. population) have access to the Internet. It is 
an appropriate and feasible method of providing information to 
customers who have access to the Internet; however, it may need to be 
used in combination with another method to ensure that all bottled 
water customers have access to CCR-type information.
    (Comment 15) Most comments stated that the Internet was not 
appropriate as the sole source of CCR-type information to bottled water 
customers and a few noted that small bottled water producers might 
experience an economic burden if made to create and maintain a website. 
A few comments indicated that the Internet is an appropriate and 
feasible method of providing bottled water information to customers. 
These comments suggested that, if creating and maintaining a website 
would be burdensome to small bottled water producers, we could defray 
the costs of their website or provide the information on our website. 
Another comment indicated that we should maintain a website with CCR-
type information on all bottled water producers.

[[Page 51838]]

    The comments did not dissuade us from our belief that the Internet 
is not appropriate as the sole source of information on bottled water 
for customers because all customers do not have access to it. Comments 
requesting that we establish a website for bottled water information or 
defray costs to small producers for creating and maintaining a website 
are beyond the scope of this study.
    (Comment 16) One comment stated that we underestimated by 1,000-
fold the cost of creating and maintaining a website.
    We estimated that it would cost $2,000 to $7,500 per year to create 
and maintain a website with information on bottled water. We believe 
our estimate is correct for the cost of a website that provides 
information only on the contents of bottled water. A website that 
contains graphics and other information would likely cost more than our 
estimate. However, we calculated the cost of providing only CCR-type 
information on bottled water to customers in a simple text format.

III. Our Final Report on the Feasibility of Appropriate Methods of 
Informing Customers of the Contents of Bottled Water

A. Information on the Contents of Bottled Water

    In the draft study, we tentatively determined that much of the 
information contained in a CCR is applicable to bottled water, with the 
exception of a definition and statement of MCLG's, information on 
public drinking water systems operating under a variance, and other 
information that is relevant only to public drinking water systems 
regulated by EPA, such as information on EPA's drinking water hotline. 
No substantive comments were received. Therefore, we have concluded 
that the information contained in a CCR, with the exceptions noted 
above, is applicable to bottled water.
    We intended to limit discussion of information on the contents of 
bottled water to information that is analogous to that outlined by EPA 
for inclusion in a CCR. However, we recognize that certain information, 
such as the type of treatment the bottled water has received, that is 
not contained in a CCR may be of particular interest to certain 
customers and, should we engage in rulemaking on this subject in the 
future, we would consider requiring that manufacturers of bottled water 
provide this information to customers.

B. Methods We Have Determined Are Appropriate and Feasible for 
Informing Customers of the Contents of Bottled Water

    There are several methods that we have determined are both 
appropriate and feasible for providing information to customers on the 
contents of bottled water. In addition, we have determined that it is 
feasible for bottled water producers to provide CCR-type information on 
bottled water, updated annually, to customers as public drinking water 
systems are required to do for their customers.
1. Information by Company Contact
    In the draft study, we tentatively determined that a phone number 
or an address on the label directing customers on how to obtain 
information from the company is an appropriate and feasible method of 
providing information to customers. Comments did not provide any 
information contradicting our tentative determination. Therefore, we 
have determined that it is both appropriate and feasible to provide 
CCR-type information to customers through a phone number or an address 
on the label directing customers on how to obtain information from the 
company.
2. Information by the Combination Approach
    We also believe that the combination approach (i.e., particular 
pieces of CCR-type information would be placed on the label, and the 
remainder of the information would be available through contact with 
the company by phone or mail) is appropriate and feasible. In the draft 
study, we tentatively determined that this method is appropriate and 
feasible and has the benefit of delivering certain pieces of 
information to customers at the point of purchase. The majority of 
comments agreed with our tentative conclusion.
    Therefore, we have determined that the combination approach is an 
appropriate and feasible method of providing CCR-type information to 
bottled water customers, provided that the information that appears on 
the label does not result in excessive information (e.g., contaminant 
listings that would require considerable additional text to place the 
information in context for the bottled water customer) in limited label 
space.
3. Distribution of an Information Package With Bulk Water Deliveries
    In the draft study, we tentatively concluded that this is an 
appropriate and feasible method of informing bulk bottled water 
customers of the contents of bottled water by distributing an 
information package with bulk water deliveries. The majority of 
comments to the draft study agreed with our tentative conclusion.
    We have determined that it is both appropriate and feasible for 
bulk water deliverers to include an information package containing CCR-
type information on bottled water with a bill or to deliver the 
information package with an invoice.

C. Methods We Have Determined Are Not Appropriate and Feasible for 
Informing Customers of the Contents of Bottled Water

    There are several methods that we have determined are not 
appropriate and feasible for providing information to customers on the 
contents of bottled water.
1. Information on the Label
    In the draft study, we stated that placing information on the label 
is an appropriate method of conveying information to bottled water 
customers; however, we questioned the feasibility of placing all CCR-
type information, in particular information that might change 
frequently, on the label of bottled water. Concerns over excessive 
information in limited label space, potential misbranding and the 
potential economic burden of frequent label changes led us to 
tentatively determine that it is not feasible to place all of the 
information on a bottled water label that would be analogous to 
information contained in a CCR.
    Some comments received on the draft study maintained that customers 
need CCR-type information in order to be informed and that this 
information would not crowd the label because the number of 
contaminants listed would be minimal, even though these comments also 
advocated information on allowable levels, possible sources of the 
contaminant, and health effects information to be included on the 
label. We continue to have concerns about excessive information in 
limited label space and the cost of frequent label changes. We believe 
that the amount of information that would need to go on the label to 
place the contaminant information, as suggested in these comments, in 
context for the bottled water customer may be considerable and could 
lead to excessive information in limited label space. Therefore, we 
have determined that placing all of the information that is analogous 
to that contained in a CCR on a bottled water label is not an 
appropriate and feasible method to inform customers of the contents of 
bottled water.

[[Page 51839]]

2. Information in a Pamphlet
    In the draft study, we tentatively determined that providing CCR-
type information to customers in a pamphlet available at retail may not 
be the most feasible method of informing customers when other methods 
are available. We cited concerns over ensuring that the information in 
the pamphlets is current and that the pamphlets are consistently 
available at retail. Comments received on the draft study agreed with 
our assessment. Therefore, we have determined that placing pamphlets 
containing CCR-type information with bottled water at retail is not a 
feasible method of informing customers of the contents of bottled 
water.
3. Information Available on the Internet
    In the draft study, we tentatively concluded that the Internet is 
not appropriate as the sole method of providing information on the 
contents of bottled water to customers because not all customers may 
have access to it. Most comments agreed with our tentative conclusion. 
Therefore, we have determined that the Internet is not appropriate as 
the sole method of providing information on the contents of bottled 
water to customers.

    Dated: August 21, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-21757 Filed 8-22-00; 3:50 pm]
BILLING CODE 4160-01-F