
[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Notices]
[Pages 63228-63229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3655]


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 or we) 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 solicits 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 December 18, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions''.
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-3655 for the information collection request entitled, 
``Agency Information Collection Activities; Proposed Collection; 
Comment Request; Recordkeeping Requirements for Microbiological Testing 
and Corrective Measures for Bottled Water''.
    Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions'', publicly viewable at 
http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential''. Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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

[[Page 63229]]

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, we 
are publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, we invite 
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, follow-up 
testing must be conducted to determine whether any of the coliform 
organisms are Escherichia coli (E. 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.
    We estimate the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                       Number of
                     21 CFR section; activity                         Number of       records per    Total annual    Average  burden per    Total hours
                                                                    recordkeepers    recordkeeper       records         recordkeeping
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Sec.   129.35(a)(3)(i), Sec.   129.80(h); Bottlers subject to                  319               6           1,914      0.08 (5 minutes)             153
 source water and finished product testing.......................
Sec.   129.80(g), Sec.   129.80(h); Bottlers testing finished                   95               3             285      0.08 (5 minutes)              23
 product only....................................................
Sec.   129.35(a)(3)(i), Sec.   129.80(h); Bottlers conducting                    3               5              15      0.08 (5 minutes)               1
 secondary testing of source water...............................
Sec.   129.35(a)(3)(i), Sec.   129.80(h); Bottlers rectifying                    3               3               9     0.25 (15 minutes)               2
 contamination...................................................
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    Total........................................................  ...............  ..............  ..............  ....................             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 
follow-up 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 follow-up 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 three 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 three 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 follow-up test for E. 
coli.
    We expect 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, we expect that three 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: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26442 Filed 10-16-15; 8:45 am]
BILLING CODE 4164-01-P


