
[Federal Register Volume 78, Number 13 (Friday, January 18, 2013)]
[Notices]
[Pages 4152-4153]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01032]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0333]


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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice invites comments on the procedure by which both 
domestic and foreign bottled water manufacturers that sell bottled 
water in the United States maintain records of microbiological testing 
and corrective measures, in addition to existing recordkeeping 
requirements.

DATES: Submit either electronic or written comments on the collection 
of information by March 19, 2013.

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: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, domini.bean@fda.hhs.gov.

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, including 
each proposed extension of an existing 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) (OMB Control Number 0910-0658)--Extension

    The bottled water regulations in parts 129 and 165 (21 CFR parts 
129 and 165) require that if any coliform organisms are detected in 
weekly total coliform testing of finished bottled water, followup 
testing must be conducted to determine whether any of the coliform 
organisms are Escherichia coli. The adulteration provision of the 
bottled water standard (Sec.  165.110(d)) provides that a 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, the current good manufacturing practice 
(CGMP) regulations for bottled water in part 129 require 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 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 4153]]



                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                              Number of records     Total annual      Average burden
               21 CFR Section                     Number of recordkeepers      per recordkeeper       records       per recordkeeping     Total hours
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Sec.   129.35(a)(3)(i), Sec.   129.80(h)....  319 (bottlers subject to                        6              1,914               0.08                153
                                               source water and finished
                                               product testing).
Sec.   129.80(g), Sec.   129.80(h)..........  95 (bottlers testing finished                   3                285               0.08                 23
                                               product only).
Sec.   129.35(a)(3)(i), Sec.   129.80(h)....  3 (bottlers conducting                          5                 15               0.08                1.2
                                               secondary testing of source
                                               water).
Sec.   129.35(a)(3)(i), Sec.   129.80(h)....  3 (bottlers rectifying                          3                  9                .25                  2
                                               contamination).
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    Total Annual Burden.....................  ..............................  .................  .................  .................                179
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\1\ There are no capital costs or operating and maintenance 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. We therefore 
conclude that any additional burden and costs in recordkeeping based on 
followup testing that is required if any coliform organisms detected in 
the source water test positive for E. coli are negligible. We estimate 
that the labor burden of keeping records of each test is about 5 
minutes per test. We also require followup testing of source water and 
finished bottled water products for E. coli when total coliform 
positives occur. We expect 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 three 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 
sample, bottlers will then have to conduct a followup test for E. coli.
    We expect that recordkeeping for the followup test for E. coli will 
also take about 5 minutes per test. As shown in table 1 of this 
document, we expect that 3 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, we estimate a total 
burden of 179 hours. We base our estimate on our experience with the 
current CGMP regulations.

    Dated: January 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01032 Filed 1-17-13; 8:45 am]
BILLING CODE 4160-01-P


