Source: https://www.federalregister.gov/documents/2009/05/29/E9-12493/agency-information-collection-activities-proposed-collection-comment-request-recordkeeping
Timestamp: 2017-08-24 02:09:51
Document Index: 282394509

Matched Legal Cases: ['arts 129', 'arts 129', '§\u2009165', 'art 129', '§\u2009129', '§\u2009129', '§\u2009129', '§\u2009129']

A Notice by the Food and Drug Administration on 05/29/2009
Submit written or electronic comments on the collection of information by July 28, 2009.
74 FR 25752
E9-12493
https://www.federalregister.gov/d/E9-12493 https://www.federalregister.gov/d/E9-12493
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information provisions of the final rule, “Beverages: Bottled Water,” published elsewhere in this issue of the Federal Register, which requires both domestic and foreign bottled water manufacturers that sell bottled water in the United States to maintain records of Escherichia coli testing and corrective measures, in addition to existing recordkeeping requirements.
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, follow-up 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 (§ 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 24-hour 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.
§§ 129.35(a)(3)(i) and 129.80(h) 319 (bottlers subject to source water and finished product testing) 6 1,914 0.08 153
§§ 129.35(a)(3)(i) and 129.80(h) 2.5 (bottlers conducting secondary testing of source water) 5 12 0.08 1
§§ 129.35(a)(3)(i) and 129.80(h) 2.5 (bottlers rectifying contamination) 3 7.5 0.25 2
§ 129.80(g) and (h) 95 (bottlers testing finished product only) 3 285 0.08 23
1 There are no capital costs or operating costs associated with this collection of information.
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 follow-up 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 follow-up test for E. coli.
FDA expects that recordkeeping for the follow-up 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.
[FR Doc. E9-12493 Filed 5-26-09; 4:15 pm]