Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Microbiological Testing and Corrective Measures for Bottled Water

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.

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.

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

21 CFR section; activity

Number of

recordkeepers

Number of

records per

recordkeeper

Total

annual

records

Average burden per recordkeeping

Total

hours

129.35(a)(3)(i), 129.80(h); bottlers subject to source water and finished product testing

319

6

1,914

0.08 (5 minutes)

153

129.80(g), 129.80(h); bottlers testing finished product only

95

3

285

0.08 (5 minutes)

23

129.35(a)(3)(i), 129.80(h); bottlers conducting secondary testing of source water

3

5

15

0.08 (5 minutes)

1

129.35(a)(3)(i), 129.80(h); bottlers rectifying contamination

3

3

9

0.25 (15 minutes)

2

Total

179

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