Notice2022-01370
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
Primary source
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Published
January 25, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 16 (Tuesday, January 25, 2022)</title>
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[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Pages 3818-3819]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#5f0f0d1e0c2b3e39391f393b3e7137372c71383029"><span class="__cf_email__" data-cfemail="26767467755247404066404247084e4e5508414950">[email protected]</span></a>.
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
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