[Federal Register Volume 84, Number 61 (Friday, March 29, 2019)]
[Notices]
[Pages 11984-11985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4130]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
29, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0658. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

[[Page 11985]]

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 (21 CFR 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.
    In the Federal Register of November 7, 2018 (83 FR 55726), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                   Number of                     Average burden
   21 CFR section; activity        Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   129.35(a)(3)(i)               319               6           1,914  0.08 (5 minutes)             153
 and 129.80(h) (bottlers
 subject to both source water
 and finished product testing).
Sec.   129.80(g) and (h)                    95               3             285  0.08 (5 minutes)              23
 (bottlers only subject to
 finished product testing).
Sec.  Sec.   129.35(a)(3)(i)                 3               5              15  0.08 (5 minutes)               1
 and 129.80(h) (bottlers
 conducting secondary testing
 of source water).
Sec.  Sec.   129.35(a)(3)(i)                 3               3               9  0.25 (15                       2
 and 129.80(h) (bottlers                                                         minutes).
 rectifying contamination).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             179
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.
    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 E. 
coli followup 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 water testing and 
about 3 times in finished product testing and thus would need to 
conduct 6 tests for E. coli, for a total of 153 hours of recordkeeping. 
In addition, about 95 bottlers that use PWSs may find a total coliform 
positive sample about 3 times per year in finished product testing and 
thus would need to conduct 3 tests for E. coli, for a total of 23 hours 
of recordkeeping.
    We expect that three bottlers per year will test positive for E. 
coli in source water and will need to take actions to rectify or 
eliminate the cause of the contamination and verify that E. coli is 
negative by taking five samples over a 24-hour period from the same 
sampling site that originally tested positive 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, we expect that three 
bottlers per year will test positive for E. coli in source water and 
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: March 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06069 Filed 3-28-19; 8:45 am]
BILLING CODE 4164-01-P


