# 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.
**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 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:
| 21 CFR section; activity | Number of | Number of | Total annual | Average burden per recordkeeping | Total hours |
| --- | --- | --- | --- | --- | --- |
| §§ 129.35(a)(3)(i) and 129.80(h); bottlers subject to both source water and finished product testing | 319 | 6 | 1,914 | 0.08 (5 minutes) | 153 |
| § 129.80(g) and (h); bottlers only subject to finished product testing | 95 | 3 | 285 | 0.08 (5 minutes) | 23 |
| §§ 129.35(a)(3)(i) and 129.80(h); bottlers conducting secondary testing of source water | 3 | 5 | 15 | 0.08 (5 minutes) | 1 |
| §§ 129.35(a)(3)(i) and 129.80(h); bottlers rectifying contamination | 3 | 3 | 9 | 0.25 (15 minutes) | 2 |
| Total | | | | | 179 |
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.