    [Federal Register Volume 90, Number 84 (Friday, May 2, 2025)]
    [Notices]
    [Pages 18859-18860]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 2025-07629]

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    DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Food and Drug Administration

    [Docket No. FDA-2024-N-2931]

    Agency Information Collection Activities; Submission for Office
    of Management and Budget Review; Comment Request; 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: Submit written comments (including recommendations) on the
    collection of information by June 2, 2025.

    ADDRESSES: To ensure that comments on the information collection are
    received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
    collection by selecting ``Currently under Review--Open for Public
    Comments'' or by using the search function. The OMB control number for
    this information collection is 0910-0658. Also include the FDA docket
    number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
    Food and Drug Administration, Three White Flint North, 10A-12M, 11601
    Landsdown St., North Bethesda, MD 20852, 301-796-8867,
    PRAStaff@fda.hhs.gov.

    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 18860]]

    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

        This information collection supports FDA regulations. 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 (E. 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 be tested at least weekly
    for total coliform. If any coliform organisms are detected in the
    source water, 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 July 23, 2024 (89 FR 59742), FDA
    published a 60-day notice requesting public comment on the proposed
    collection of information. Five comments were received, of which one
    was PRA-related and supported necessity and practical utility of the
    FDA's recordkeeping requirements in this collection of information.
    Four comments were not related to the PRA and will not be addressed
    here.
        FDA estimates the burden of this collection of information as
    follows:

                                   Table 1--Estimated Annual Recordkeeping Burden \1\
    ----------------------------------------------------------------------------------------------------------------
                                                                             Total      Average burden
       21 CFR section; activity         Number of      Number of records     annual           per           Total
                                      recordkeepers     per recordkeeper    records      recordkeeping      hours
    ----------------------------------------------------------------------------------------------------------------
    129.35(a)(3)(i), 129.80(h);                   319                  6        1,914  0.08 (5 minutes)          153
     bottlers subject to source
     water and finished product
     testing.
    129.80(g), 129.80(h); bottlers                 95                  3          285  0.08 (5 minutes)           23
     testing finished product only.
    129.35(a)(3)(i), 129.80(h);                     3                  5           15  0.08 (5 minutes)            1
     bottlers conducting secondary
     testing of source water.
    129.35(a)(3)(i), 129.80(h);                     3                  3            9  0.25 (15                    2
     bottlers rectifying                                                                minutes).
     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.

        Dated: April 24, 2025.
    Grace R. Graham,
    Deputy Commissioner for Policy, Legislation, and International Affairs.
    [FR Doc. 2025-07629 Filed 5-1-25; 8:45 am]
    BILLING CODE 4164-01-P