Federal Register: October 28, 2009 (Volume 74, Number 207)
DOCID: fr28oc09-64 FR Doc E9-25927
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. FDA-2009-N-0215]
DOCUMENT ACTION: Notice.
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
DATES: Fax written comments on the collection of information by November 27, 2009.
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.
Agency Information Collection Activities; Proposals, Submissions, and Approvals
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 Water21 CFR 129.35(a)(3)(i) and 129.80(g) and (h)
FDA has amended its bottled water regulations in parts 129 and 165 (21 CFR parts 129 and 165) by requiring 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 E. coli. FDA also amended the adulteration provision of the bottled water standard (Sec. 165.110(d)) to indicate that 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, FDA amended the Current Good Manufacturing Practices (CGMP) regulations for bottled water in part 129 by requiring that source water from other than a public water system (PWS) be tested at least weekly for total coliform. If any coliform organisms are detected in the source water, the 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 24hour period from the same sampling site are tested and found to be E. coli negative.
Description of Respondents: The respondents to this proposed information collection are domestic and foreign bottled water manufacturers that sell bottled water in the United States.
In the Federal Register of May 29, 2009 (74 FR 25752 ), FDA
published a 60day notice requesting public comment on the proposed collection of information. No comments were received.
Table 1.Estimated Annual Recordkeeping Burden\1\ No. of Annual Frequency Total Annual 21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours Sec. Sec. 319 (bottlers 6 1,914 0.08 153 129.35(a)(3)(i) subject to
and 129.80(h) source water
Sec. Sec. 2.5 (bottlers 5 12 0.08 1 129.35(a)(3)(i) conducting
and 129.80(h) secondary
Sec. Sec. 2.5 (bottlers 3 7.5 0.25 2 129.35(a)(3)(i) rectifying
and 129.80(h) contamination)
Sec. 129.80(g) 95 (bottlers 3 285 0.08 23 and (h) testing
Total Annual Burden 179 \1\There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 55558]]
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. FDA therefore concludes that any additional burden and costs in recordkeeping based on the new testing requirements for source and finished bottled water are negligible. FDA estimates that the labor burden of keeping records of each test is about 5 minutes per test. FDA also requires followup testing of source water and finished bottled water products for E. coli when total coliform positives occur. FDA expects that 319 bottlers that use sources other than PWSs may find a total coliform positive sample about 3 times per year in source testing and about 3 times in finished product testing, for a total of 153 hours of recordkeeping. In addition to the 319 bottlers, about 95 bottlers that use PWSs may find a total coliform positive sample about 3 times per year in finished product testing, for a total of 23 hours of recordkeeping. Upon finding a total coliform positive sample, bottlers will then have to conduct a followup test for E. coli.
FDA expects that recordkeeping for the followup test for E. coli
will also take about 5 minutes per test. As shown in table 1 of this
document, FDA expects that 2.5 bottlers per year will have to carry out
the additional E. coli testing, with a burden of 1 hour. These bottlers
will also have to keep records about rectifying the source
contamination, for a burden of 2 hours. For all expected total coliform
testing, E. coli testing, and source rectification, FDA estimates a
total burden of 179 hours. FDA bases its estimate on its experience with the current CGMP regulations.
Dated: October 20, 2009.
Assistant Commissioner for Policy.
[FR Doc. E925927 Filed 102709; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Jonna Capezzuto, Office of Information
Management (HFA710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 3017963794, email: