[Federal Register Volume 65, Number 35 (Tuesday, February 22, 2000)]
[Notices]
[Pages 8718-8722]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-4025]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0436]


Food and Drug Administration Draft 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 for 
comment a draft 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 Amendments. This draft feasibility study 
report evaluates and identifies appropriate methods that may be 
feasible for conveying information about bottled water to customers.

DATES: Written comments must be received by April 24, 2000.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rebecca 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: The text of the draft study report on the 
feasibility of appropriate methods of informing customers of the 
contents of bottled water follows:
    FDA Draft Study Report: Feasibility of Appropriate Methods of 
Informing Customers of the Contents of Bottled Water

I. Background

    On August 6, 1996, the President signed into law the Safe Drinking 
Water Act (SDWA) Amendments (Public Law 104-182). Under the Public 
Notification section of the Amendments, the Environmental Protection 
Agency (EPA) was required to issue regulations mandating that each 
community water system provide each customer of the system with 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 the next section of this document entitled ``FDA's 
Evaluation of Information about the Contents of Bottled Water.''
    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 this proposal, EPA published a 
final rule on August 19, 1998 (63 FR 44512). Section 114(b) of the SDWA 
Amendments also required that, no more than 18 months after the date of 
its enactment, the Food and Drug Administration (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.
    In a notice published in the Federal Register of November 12, 1997 
(62 FR 60721) (hereinafter ``the 1997 notice''), FDA requested comment 
on several matters relevant to the feasibility of appropriate methods 
of informing customers of the contents of bottled water. We have 
evaluated the information received and identified appropriate methods 
that may be feasible for conveying information about bottled water to 
customers. This draft feasibility study presents the agency's 
evaluation of those methods. Congress, under the SDWA Amendments, did 
not expressly address FDA's authority for implementing, by regulation, 
any appropriate methods deemed feasible. Should FDA, in the future, 
decide to engage in rulemaking on this subject, FDA would discuss, in 
such a rulemaking, the agency's statutory authority for requiring any 
of the types of information or for requiring a specific method for 
conveying such information on the contents of bottled water to 
customers. However, such a discussion is outside the scope of this 
study. Comments received on this draft report will be evaluated and 
considered in preparation of the final report on the feasibility of 
appropriate methods, if any, for providing information about the 
contents of bottled water to customers.
    In the 1997 notice, FDA asked for specific information to use in 
generating the feasibility study. The agency considered this to be the 
most effective means of obtaining information from all segments of the 
general public (i.e., industries, trade associations, consumers, 
consumer advocacy groups, educational institutions) that are interested 
in the subject of the feasibility of appropriate methods of providing 
information on bottled water to customers. The following specific 
information was requested: (1) What methods, if any, may be appropriate 
for conveying information about the contents of bottled water to 
customers, and why they are appropriate; (2) for each method identified 
as being appropriate for conveying information to customers, whether 
such method is or is not feasible and the supporting reasons why the 
method is or is not feasible; and (3) the type of information about the 
contents of bottled water that should be provided to customers within 
the context of the SDWA Amendments and that would, to the extent 
possible, be analogous to the information provided in a CCR.
    The agency received 51 letters in response to the 1997 notice. Many 
comments stated that it is not necessary to provide customers with more 
information than they currently receive on bottled water. Comments that 
expressed these opinions are beyond the scope of this report and are 
not discussed.

II. Information About the Contents of Bottled Water

    In the 1997 notice, FDA requested comments on the type of 
information about the contents of bottled water that should be provided 
to customers that would, to the extent possible, be analogous to 
information provided in a CCR. To that end, the agency notes that a 
CCR, as outlined by EPA, contains: (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 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

[[Page 8719]]

granted; (5) information on the levels of unregulated contaminants for 
which 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 1997 notice, we requested comments on what information 
analogous to that in a CCR should be provided to customers. We realize 
that not all of the information in a CCR is relevant to bottled water. 
For example, FDA establishes ``allowable levels'' for contaminants, not 
MCL's (FDA has established allowable levels for 83 contaminants in 
bottled water).
    A few comments stated that FDA was exceeding its congressional 
mandate in soliciting comments on information about the contents of 
bottled water that could be reported to customers. These comments 
stated that the agency was asked to study the feasibility of 
appropriate methods of informing customers about the contents of 
bottled water and was not asked to evaluate information about the 
contents.
    We disagree with these comments. In order to consider the 
feasibility of appropriate methods of informing customers of the 
contents of bottled water, we must consider the type and amount of 
information on the contents of bottled water that may be included 
within the context of the SDWA Amendments. Many who commented indicated 
that it was possible to provide information similar to that found in a 
CCR for bottled water. However, several comments stated that a list of 
all detected contaminants should not be provided because this would be 
confusing to customers and indicated that only contaminants in 
violation of allowable levels should be listed.
    Many comments stated that it was appropriate to discuss contaminant 
limits in bottled water in terms of allowable levels rather than MCL's. 
MCL is the term used in EPA's, but not FDA's, regulations. However, a 
few comments maintained that bottled water contaminant limits should be 
expressed as MCL's for the sake of consistency.
    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 
sodium content. A ``date bottled'' statement and a statement of the 
type of treatment or disinfection that the water received also were 
suggested as information that would be of interest to customers. Some 
comments stated that treatment or disinfection information is important 
to immunocompromised individuals in determining 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, 
a parasite that has caused serious waterborne illness outbreaks from 
the consumption of contaminated public drinking water.

FDA's Evaluation of Information About the Contents of Bottled Water

    We believe that much of the information contained in a CCR is 
applicable to bottled water. However, 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 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.
    The agency notes that certain information not required in a CCR, 
e.g., ``date bottled,'' mineral profile, pH and type of treatment given 
to water (for immunocompromised consumers), may be of interest to some 
bottled water customers. However, with the exception of information 
related to the potential presence of Cryptosporidium in bottled water 
(type of treatment), this information is not analogous to information 
contained in a CCR. In soliciting comments on the type of information 
on bottled water that could be provided to customers, we specified in 
the 1997 notice (62 FR 60721 at 60722) that the information should be 
within the context of the SDWA Amendments and, to the extent possible, 
be analogous to that contained in a CCR. The agency's 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.

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

    In the 1997 notice, FDA suggested several possible methods for 
conveying information, i.e., providing the information on the label of 
the bottle or in a pamphlet made available at point of sale, or listing 
a phone number or an address on the label that the customer could use 
to access information, or providing the information on an Internet site 
that customers could access. We also suggested that firms making bulk 
deliveries might provide their customers with the information directly 
or by mail. The agency recognized that the aforementioned methods do 
not represent all possible methods that may be appropriate and 
interested persons were asked to suggest other methods.
    For each method identified as being appropriate for conveying 
information to customers about the contents of bottled water, FDA 
requested comments on whether the provision of information by the 
method is or is not feasible, i.e., is or is not ``capable of being 
done or carried out'' (Webster's Third New International Dictionary, 
1976). Although not explicitly stated in the 1997 notice, we note that 
practicality is an important element of feasibility. Additionally, 
interested persons were asked to state why a particular method would be 
feasible or not feasible, addressing costs and other relevant factors 
(e.g., label space) in their comments.
    The agency received comments on the appropriateness and feasibility 
of six methods of informing customers of the contents of bottled water. 
These methods include 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. The supporting reasons for why 
each method identified is appropriate and the feasibility of each 
method as described in comments are discussed in the subsequent 
sections. Further, FDA's evaluation of each method is presented.

A. Information on the Label

    Several comments identified the use of the label as an appropriate 
method because labels are designed specifically to convey information 
to customers. In fact, a few comments stated that the

[[Page 8720]]

only appropriate method was the label because it allows customers to 
have access to all available information at the point of purchase.
    Alternatively, several comments stated that it would be 
inappropriate to place the information contained in a CCR on the label 
of bottled water. These comments noted that all food labels are 
required by law to carry certain pieces of information. Requiring 
additional information on the labels of bottled water would not be in 
keeping with labeling requirements for all other food products. Some 
comments also contended that additional information on the label might 
frighten or confuse customers because they would not understand the 
significance of information such as levels of trace contaminants in 
bottled water.
    A few comments indicated that it would be feasible to include all 
of the information which would appear in a CCR on the label if the size 
of the label were increased or a fold-out label were used. However, the 
majority of comments indicated that it was not feasible to place 
significantly more information on a label based upon current label 
sizes.
1. Costs Associated With the Method
    One comment estimated that, because of the amount of information, 
the cost of adding comprehensive CCR information would cost 
significantly more than the cost of adding a nutrition facts panel to a 
label (i.e., would cost more than $24,000 for a medium-sized bottled 
water company with eight product labels and three package sizes). 
Several comments stated that changing a label significantly could be an 
economic hardship for small companies.
    We estimate the average cost of making a label change for firms in 
this industry to be between $2,200 and $17,900, depending upon the 
complexity of the label change, the number of labels a company uses, 
and the time parameters for implementing the changes. Costs would be 
higher if testing that the company currently does not perform was 
necessary to generate additional information that may be of interest to 
customers. These costs could be substantially greater if it became 
necessary to make multiple label changes in response to changing test 
results, for example, from ongoing monitoring for chemical and 
microbiological contaminants. Bottled water regulations for monitoring 
for chemical and microbiological contaminants require weekly monitoring 
for some contaminants and yearly monitoring for others. A change in the 
levels detected from week-to-week or year-to-year would necessitate a 
label change.
2. FDA's Evaluation
    We agree that placing information on the label is an appropriate 
method of informing customers about the contents of bottled water. 
However, we question the feasibility of placing all of the information 
on the contents of bottled water, that is analogous to that contained 
in a CCR, on the label of bottled water. The amount of information 
contained in a CCR, as outlined by EPA, is considerable (see section II 
of this document). We believe that the placement of all analogous CCR 
information on the label would lead to label clutter due to space 
requirements for such information. Therefore, we believe it is not 
feasible to place all such information on the contents of bottled water 
on the product label.
    The agency also has 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 
its ``Processing and Bottling of Bottled Drinking Water'' regulations 
(21 CFR part 129). Labeling changes for information that may change 
frequently could result in an economic hardship to companies and, in 
addition, would result in the possibility that a product might bear a 
label that was no longer accurate, due to changing test results, which 
may cause the product to be misbranded under section 403 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343). Therefore, we believe 
placing all analogous CCR information on bottled water on the label is 
not economically feasible.

B. Information Available by Company Contact

    Several comments considered an appropriate method for informing 
customers of the contents of bottled water to be through a customer 
request by calling a phone number or writing to an address provided on 
the label. It was noted that the customer would have to go to some 
effort to get the information in this case, but comments still 
considered the method to be appropriate because customers who were 
interested in receiving information could do so. Several comments 
indicated that historically there has been little customer interest in 
information on the contents of bottled water.
    Comments also stated that this would be a feasible method of 
conveying information to customers. This method was considered feasible 
because it is already being employed by a number of bottlers and, 
therefore, neither costly label changes nor greatly increasing the size 
of the product label would be necessary.
1. Costs Associated With the Method
    The costs associated with providing information in response to 
requests made by calling a phone number or writing to an address on the 
label depend upon how the company chooses to provide this information 
(e.g., operation of a toll number, a toll-free number, or a mail-
response system), the volume of customer requests for information, and 
the amount of time required to answer requests. FDA estimates that 
costs for this option would be between $1,200 and $4,200 annually, 
depending on the method chosen. In addition, any product label that 
does not already provide contact information will have to be changed to 
provide that information. We estimate the average cost of making a 
simple one-time label change for firms in this industry to be between 
$2,200 and $12,800. Finally, FDA notes that the customer will incur 
costs for acquiring information on bottled water if a company chooses 
to provide a toll number, rather than a toll-free number, on the label.
2. FDA's Evaluation
    We agree that a phone number or an address on the label directing 
customers on how to obtain information from the company is an 
appropriate method of providing information to customers. Telephones 
and mail are available to almost all customers. The information would 
be accessible to customers with this method, although the agency does 
note that some effort will be required on the part of the customer to 
obtain the information. Dissemination of information in this manner may 
be less likely to confuse customers if the system allowed customers to 
be selective by obtaining only information in which they have an 
interest rather than all the information that may be available. 
Information provided in this manner can also be kept current.
    We believe that providing information through a phone number or an 
address is feasible. It is the least costly method to industry of 
providing information to customers because it does not require frequent 
label changes and is therefore less costly to maintain. Moreover, the 
start up costs would only apply to a portion of the industry since many 
firms already provide information to customers in this manner.

[[Page 8721]]

C. Information Available by the Combination Approach

    Many comments advocated placing certain individual pieces of 
information, such as information on source of the water, information 
about the suitability of the water for consumption by immunocompromised 
individuals or fluoride levels, on the label, while making other CCR-
type information available to customers through contact with the 
company (i.e., a combination approach). Comments stated that this would 
be both appropriate and feasible and noted that this would give 
customers access to certain pieces of information that may be of 
interest to them at point of purchase.
1. Costs Associated With the Method
    The costs associated with providing information in response to 
customer requests for the information through company contact would be 
similar to those listed in the previous section. This option would also 
entail a label change for companies, estimated to cost a minimum of 
between $2,200 and $12,800 for the initial change. Whether or not there 
would be additional costs for subsequent label changes would depend 
upon whether the information required to be on the label could change 
as a result of ongoing monitoring of the product.
2. FDA's Evaluation
    We agree that the combination approach is an appropriate method of 
providing information to customers. We also agree 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.
    Comments that advocated the combination approach requested that 
particular pieces of information, that may be of interest to customers 
at point of purchase, be placed on the label. The agency notes that, in 
order to fully explore the combination approach in the final 
feasibility report, advocates of the combination approach should 
provide information on which pieces of CCR-type information should go 
on the label and which should be available through company contact.

D. Information in a Pamphlet

    None of the comments considered placement of a pamphlet containing 
information about bottled water at the point of purchase an appropriate 
method. The comments stated that retail establishments might not want 
to provide the necessary display space.
1. Costs Associated With the Method
    Costs associated with providing information on bottled water to 
customers in a pamphlet depend upon the quality of the paper and 
printing, the size of the pamphlet, and the use of color. We estimate 
that it would cost a company between $3,500 and $16,500 per year to 
distribute 10,000 pamphlets.
2. FDA's Evaluation
    The agency is not aware that retailers necessarily would not want 
to provide space for pamphlets. The agency does believe, however, that 
this would 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 regarding assuring that the pamphlets were consistently 
available at point of purchase. Therefore, we do not believe that 
pamphlets would be the most feasible method of providing information on 
the contents of bottled water to customers.

E. Distribution of an Information Package With Bulk Water Deliveries

    The majority of the comments indicated that it would be appropriate 
for bulk water deliverers to include an information package with a bill 
or deliver it with an invoice. Comments also stated that this would be 
feasible since bulk water deliverers have regular contact with their 
customers.
1. Costs Associated With the Method
    If an informal information package were prepared for delivery or 
inclusion with an invoice, we estimates the cost to be between $1 and 
$2 per package. If a firm makes 20 bulk deliveries per week, then the 
yearly cost would be $1,000 to $2,000.
2. FDA's Evaluation
    The agency believes 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.

F. Information Available on the Internet

    A small number of comments indicated that the Internet was an 
appropriate method for conveying information to customers. However, the 
majority of comments stated that the internet was not appropriate as 
the sole source of information because some customers may not have 
access to it.
1. Costs Associated With the Method
    The cost of creating and maintaining a web site also was considered 
prohibitive for small companies. Comments stated that the cost of 
creating a web site is approximately $7,500.
    We estimate the cost of creating and maintaining an Internet 
website to be between $2,000 and $7,500. For firms that already 
maintain a website, the cost of adding information on the contents of 
bottled water would be negligible.
2. FDA's Evaluation
    Although the Internet is increasingly popular, FDA agrees that the 
internet may not be appropriate as the sole source of information about 
the contents of bottled water. 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. Since many customers may not have access to the Internet, the 
agency believes that it may not be appropriate for the Internet to be 
the sole source of information on the contents of bottled water for 
customers. The Internet is an appropriate and feasible method of 
providing information to customers; however, it may need to be used in 
combination with another method to ensure that all bottled water 
customers have access to the information.

IV. Summary

    We believe that much of the information contained in a CCR is 
applicable to bottled water. However, we recognize that certain 
information contained in a CCR is relevant only to public drinking 
water systems regulated by EPA. For example, a CCR includes the 
definition and statement of MCLG's, information on public drinking 
water systems operating under a variance, and information on EPA's 
drinking water hotline.
    The agency has tentatively determined that certain methods are 
appropriate and feasible for informing customers of the contents of 
bottled water. We believe that providing analogous CCR information on 
bottled

[[Page 8722]]

water by company contact through an address or phone number on the 
label is an appropriate and feasible method. We believe that the 
combination approach (providing some content information on the label 
along with a company contact) is an appropriate and feasible method of 
providing customers with information and, in addition, has the benefit 
of delivering certain pieces of information to customers at the point 
of purchase. The agency also believes that it would be an appropriate 
method and is feasible for bulk deliverers to provide an information 
package with a bill or an invoice.
    The agency has tentatively determined that certain methods are not 
appropriate and feasible for informing customers of the contents of 
bottled water. We believe that placing all of the information analogous 
to that contained in a CCR on the label of bottled water is not 
feasible. Moreover, there is a potential economic burden of frequent 
label changes if the particular information that is placed on the label 
requires frequent label changes as a result of ongoing monitoring of 
contaminants. We have the same concerns regarding changing test results 
for information provided in a pamphlet at point of purchase. We also 
question the practicality of ensuring that pamphlets are consistently 
available at retail. Further, the agency does not believe that the 
Internet may be 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.
    Comments received on this draft report will be evaluated and 
considered in preparation of the final report on the feasibility of 
appropriate methods, if any, for providing information about the 
contents of bottled water to customers. Based on the comments received, 
the agency plans to discuss the possibility of further action on this 
subject, if any is necessary, in the final report.

    Dated: February 11, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-4025 Filed 2-18-00; 8:45 am]
BILLING CODE 4160-01-F