[Federal Register Volume 65, Number 35 (Tuesday, February 22, 2000)]
[Notices]
[Pages 8718-8722]
From the Federal Register Online via the Government Publishing 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