[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]
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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.
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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
