Document ID: FDA-2018-N-4130-0006
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2022-01-25T05:00Z

[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Pages 3818-3819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01370]

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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, Agency, or we) 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 February 24, 2022.

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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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.

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 (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

[[Page 3819]]

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 1, 2021 (86 FR 60258), 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
           21 CFR section; activity                Number of      records per    Total annual       Average burden per recordkeeping        Total hours
                                                 recordkeepers   recordkeeper       records
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Sec.  Sec.   129.35(a)(3)(i) and 129.80(h);                319               6           1,914  0.08 (5 minutes)........................             153
 bottlers subject to both source water and
 finished product testing.
Sec.   129.80(g) and (h); bottlers only                     95               3             285  0.08 (5 minutes)........................              23
 subject to finished product testing.
Sec.  Sec.   129.35(a)(3)(i) and 129.80(h);                  3               5              15  0.08 (5 minutes)........................               1
 bottlers conducting secondary testing of
 source water.
Sec.  Sec.   129.35(a)(3)(i) and 129.80(h);                  3               3               9  0.25 (15 minutes).......................               2
 bottlers rectifying 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.

    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: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01370 Filed 1-24-22; 8:45 am]
BILLING CODE 4164-01-P