[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\
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Total Average burden
21 CFR section; activity Number of Number of records annual per Total
recordkeepers per recordkeeper records recordkeeping hours
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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.
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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: 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