[Federal Register Volume 62, Number 218 (Wednesday, November 12, 1997)]
[Notices]
[Pages 60721-60723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29655]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0436]


Bottled Water Study: Feasibility of Appropriate Methods of 
Informing Customers of the Contents of Bottled Water; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting public 
comment on what are feasible methods for providing people who purchase 
bottled water with information about the contents of that bottled water 
and on what information should be provided. FDA will consider the 
information that it receives in response to this notice in conducting a 
study of the feasibility of appropriate methods, if any, for informing 
customers about the contents of bottled water. FDA is required to 
conduct the feasibility study under the Safe Drinking Water Act 
Amendments of 1996 (SDWA Amendments).

DATES: Written comments by December 12, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Henry Kim, Center for Food Safety and 
Applied Nutrition (HFS-306), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, 202-260-0631.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 6, 1996, Congress passed, and the President signed into 
law, the SDWA Amendments (Pub. L. 104-182). Under the SDWA Amendments' 
Public Notification (section 114) provisions designed to further public 
awareness about the quality of their drinking water, section 114(a) 
mandates that, not later than 24 months after the date of enactment of 
this law, the Environmental Protection Agency (EPA) issue regulations 
requiring community water systems to provide their customers with an 
annual report, referred to as a consumer confidence report (CCR), that 
contains information on the level of contaminants in drinking water 
purveyed by the systems.
    Parallel to this requirement, section 114(b) of the SDWA Amendments 
requires that not later than 18 months after the date of its enactment, 
FDA in

[[Page 60722]]

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. A final study is to be published not 
later than 30 months after the date of enactment of the SDWA 
Amendments.

II. Procedure for the Feasibility Study

    In carrying out the provisions of section 114(b) of the SDWA 
Amendments, FDA intends to: (1) Solicit through this notice information 
on appropriate methods, if any, that are feasible for conveying 
information about the contents of bottled water to customers; (2) 
evaluate the information received to tentatively identify the 
appropriate methods, if any, that are feasible for conveying 
information about the contents of bottled water to people who purchase 
that bottled water; (3) publish for notice and comment a draft 
feasibility study report in which the agency will present its tentative 
findings; and (4) consider the comments the agency receives on the 
draft feasibility study report and publish a final report on the 
feasibility of appropriate methods, if any, for providing information 
about the contents of bottled water to customers.
    In this notice, FDA is soliciting information that it will use in 
conducting the feasibility study. FDA is requesting comments about: (1) 
The methods, if any, that may be appropriate, and why they are 
appropriate, for conveying information about the contents of bottled 
water to consumers; (2) whether any appropriate method is feasible as a 
means of providing information about the contents of bottled water to 
customers, and the supporting reasons for why the method is feasible; 
and (3) the type of information about the contents of bottled water 
that should be provided within the context of the SDWA Amendments.
    FDA considers this solicitation of information through this Federal 
Register notice 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 feasibility of 
appropriate methods of providing information about the contents of 
bottled water to customers. FDA thus deems this approach to be the most 
appropriate means of obtaining sufficient and pertinent information 
from stakeholders for conducting the feasibility study as required by 
the SDWA Amendments.

III. Request for Information

A.  Methods for Conveying Information to Customers

    FDA requests comments on what methods, if any, are appropriate for 
conveying to customers information about the contents of bottled water. 
FDA also requests for any method identified that the comment state why 
that method is appropriate for communicating information about the 
contents of bottled water to people who purchase that product.
    For example, for bottled waters that are sold at retail (e.g., 
grocery stores), comments may wish to address whether it would be 
appropriate to provide the information directly on the product's label 
or through an address or a toll-free telephone number on the product's 
label that customers can write to or call to obtain the information. In 
the latter instance, would it be appropriate for bottlers to operate a 
menu driven system for callers to directly access the information? 
Would it be appropriate for bottlers to take the name and address of 
the caller and mail the information in the form of a pamphlet, for 
example? Comments should provide the reasons why any method identified 
is appropriate.
    Noting that the SDWA Amendments require community water systems to 
mail their annual CCR to customers, comments may wish to address 
whether it is appropriate for firms that deliver bottled water to 
customer's homes, office buildings, schools, and hospitals to mail the 
information to the customer along with the invoice that they normally 
provide. Why would providing the information in this manner be 
considered appropriate?
     Recognizing the increasing prominence of the Internet as a source 
of public information, comments may wish to address whether it is 
appropriate for firms to provide information about bottled water to 
customers over the Internet. Again, why would this method be deemed 
appropriate?
    FDA also requests comments about other methods that are appropriate 
for conveying information to customers about the contents of bottled 
water, and why they are appropriate.

B.  Feasibility of Appropriate Methods

    For each method identified as being appropriate for conveying 
information to customers about the contents of bottled water, FDA also 
requests information on whether the provision of information by such 
method is feasible, i.e., ``capable of being done or carried out'' 
(Webster's Third New International Dictionary, 1976). Thus persons who 
believe that an appropriate method is feasible for a stated purpose 
should state why the provision of information by that method can be 
done or carried out, i.e., is feasible. Likewise, interested persons 
who believe that an appropriate method is not feasible should state why 
the provision of information by that method cannot be done or carried 
out. Comments should address the costs to bottlers and all other 
relevant factors that support the position they take with respect to 
the feasibility of the method in question.
    For example, those who comment on the possibility of providing 
information directly on a product's label should address the 
feasibility of doing so in light of the obvious concern about the 
limited label space available on a bottled water product. Is it 
feasible to provide the subject information directly on the label of a 
bottled water product notwithstanding the limited label space, or is 
the limited label space such a significant obstacle that use of a 
product's label would not be feasible?
    Again, by way of example, comments that address providing the 
information on the Internet should address feasibility with respect to 
the cost of establishing and maintaining an Internet site, particularly 
for small firms.

C. Information on the Contents of Bottled Water

    FDA requests comments on the type of information about the contents 
of bottled water that should be provided to convey to customers, to the 
extent possible, information analogous to that provided in a CCR. In 
this regard, FDA notes that a CCR must contain: (1) Information about 
the source of the drinking water purveyed by the system; (2) 
definitions for the terms ``maximum contaminant level goal'' (MCLG), 
``maximum contaminant level'' (MCL), ``variances,'' and ``exemptions;'' 
(3) the MCLG, MCL, and the actual level found for contaminants detected 
in the water and, for any contaminants detected that violated 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 
is operating 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 monitoring by the system is required 
(including levels of cryptosporidium and radon where States determine 
that they may be found); and (6) a statement that the presence of 
contaminants in drinking

[[Page 60723]]

water does not necessarily indicate that the drinking water poses a 
health risk, and that more information about contaminants and potential 
health effects can be obtained by calling the EPA hotline.
    What type of information about the contents of bottled water could 
be provided that would be analogous to the previously described 
information required in a CCR? For example, because FDA establishes 
``allowable levels'' and not MCL's for contaminants in bottled water, 
would providing information describing the term ``allowable level'' as 
established in FDA's quality standard regulation for bottled water be 
analogous to the provision of information about MCL's required in a 
CCR? Also, by way of an example, for information concerning MCLG's, 
variances, exemptions that are required in a CCR, are there similar or 
analogous types of information with respect to bottled water that could 
be provided to customers?

IV. Comments

    Interested persons may, on or before December 12, 1997, submit to 
the Dockets Management Branch (address above) written comments 
regarding this document. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 3, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-29655 Filed 11-10-97; 8:45 am]
BILLING CODE 4160-01-F