[Federal Register: May 29, 2009 (Volume 74, Number 102)]
[Notices]
[Page 25752-25753]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29my09-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0215]
Agency Information Collection Activities; Proposed Collection;
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) 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.
DATES: Submit written or electronic comments on the collection of
information by July 28, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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)
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 (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 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.
FDA estimates the burden of this collection of information as
follows:
[[Page 25753]]
Table 1.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
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Sec. Sec. 319 (bottlers 6 1,914 0.08 153
129.35(a)(3)(i) subject to
and 129.80(h) source water
and finished
product
testing)
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Sec. Sec. 2.5 (bottlers 5 12 0.08 1
129.35(a)(3)(i) conducting
and 129.80(h) secondary
testing of
source water)
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Sec. Sec. 2.5 (bottlers 3 7.5 0.25 2
129.35(a)(3)(i) rectifying
and 129.80(h) contamination)
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Sec. 129.80(g) 95 (bottlers 3 285 0.08 23
and (h) testing
finished
product only)
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Total Annual Burden 179
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\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.
Dated: May 18, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12493 Filed 5-26-09; 4:15 pm]
BILLING CODE 4160-01-S