[Federal Register Volume 74, Number 102 (Friday, May 29, 2009)]
[Notices]
[Pages 25752-25753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12493]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0215]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Recordkeeping Requirements for Microbiological Testing 
and Corrective Measures for Bottled Water

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the collection of information provisions of 
the final rule, ``Beverages: Bottled Water,'' published elsewhere in 
this issue of the Federal Register, which requires both domestic and 
foreign bottled water manufacturers that sell bottled water in the 
United States to maintain records of Escherichia coli testing and 
corrective measures, in addition to existing recordkeeping 
requirements.

DATES: Submit written or electronic comments on the collection of 
information by July 28, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Recordkeeping Requirements for Microbiological Testing and Corrective 
Measures for Bottled Water--21 CFR 129.35(a)(3)(i), 129.80(g), and 
129.80(h)

    FDA has amended its bottled water regulations in parts 129 and 165 
(21 CFR parts 129 and 165) by requiring that if any coliform organisms 
are detected in weekly total coliform testing of finished bottled 
water, follow-up testing must be conducted to determine whether any of 
the coliform organisms are E. coli. FDA also amended the adulteration 
provision of the bottled water standard (Sec.  165.110(d)) to indicate 
that finished product that tests positive for E. coli will be deemed 
adulterated under section 402(a)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342(a)(3)). In addition, FDA amended the 
Current Good Manufacturing Practices (CGMP) regulations for bottled 
water in part 129 by requiring that source water from other than a 
public water system (PWS) be tested at least weekly for total coliform. 
If any coliform organisms are detected in the source water, the bottled 
water manufacturers are required to determine whether any of the 
coliform organisms are E. coli. Source water found to contain E. coli 
is not considered water of a safe, sanitary quality and would be 
unsuitable for bottled water production. Before a bottler may use 
source water from a source that has tested positive for E. coli, a 
bottler must take appropriate measures to rectify or otherwise 
eliminate the cause of the contamination. A source previously found to 
contain E. coli will be considered negative for E. coli after five 
samples collected over a 24-hour period from the same sampling site are 
tested and found to be E. coli negative.
    Description of Respondents: The respondents to this proposed 
information collection are domestic and foreign bottled water 
manufacturers that sell bottled water in the United States.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 25753]]



                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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                       No. of        Annual Frequency       Total Annual
 21 CFR Section    Recordkeepers     per Recordkeeping        Records       Hours  per Record     Total Hours
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.        319 (bottlers                       6            1,914                 0.08                153
 129.35(a)(3)(i)   subject to
 and 129.80(h)     source water
                   and finished
                   product
                   testing)
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.        2.5 (bottlers                       5               12                 0.08                  1
 129.35(a)(3)(i)   conducting
 and 129.80(h)     secondary
                   testing of
                   source water)
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.        2.5 (bottlers                       3                7.5               0.25                  2
 129.35(a)(3)(i)   rectifying
 and 129.80(h)     contamination)
----------------------------------------------------------------------------------------------------------------
Sec.   129.80(g)  95 (bottlers                        3              285                 0.08                 23
 and (h)           testing
                   finished
                   product only)
----------------------------------------------------------------------------------------------------------------
Total Annual Burden                                                                                          179
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\1\There are no capital costs or operating costs associated with this collection of information.

    The current CGMP regulations already reflect the time and 
associated recordkeeping costs for those bottlers that are required to 
conduct microbiological testing of their source water, as well as total 
coliform testing of their finished bottled water products. FDA 
therefore concludes that any additional burden and costs in 
recordkeeping based on the new testing requirements for source and 
finished bottled water are negligible. FDA estimates that the labor 
burden of keeping records of each test is about 5 minutes per test. FDA 
also requires follow-up testing of source water and finished bottled 
water products for E. coli when total coliform positives occur. FDA 
expects that 319 bottlers that use sources other than PWSs may find a 
total coliform positive sample about 3 times per year in source testing 
and about 3 times in finished product testing, for a total of 153 hours 
of recordkeeping. In addition to the 319 bottlers, about 95 bottlers 
that use PWSs may find a total coliform positive sample about 3 times 
per year in finished product testing, for a total of 23 hours of 
recordkeeping. Upon finding a total coliform positive sample, bottlers 
will then have to conduct a follow-up test for E. coli.
    FDA expects that recordkeeping for the follow-up test for E. coli 
will also take about 5 minutes per test. As shown in table 1 of this 
document, FDA expects that 2.5 bottlers per year will have to carry out 
the additional E. coli testing, with a burden of 1 hour. These bottlers 
will also have to keep records about rectifying the source 
contamination, for a burden of 2 hours. For all expected total coliform 
testing, E. coli testing, and source rectification, FDA estimates a 
total burden of 179 hours. FDA bases its estimate on its experience 
with the current CGMP regulations.

    Dated: May 18, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12493 Filed 5-26-09; 4:15 pm]
BILLING CODE 4160-01-S