
[Federal Register: October 28, 2009 (Volume 74, Number 207)]
[Notices]               
[Page 55557-55558]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc09-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0215]

 
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.

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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: Fax written comments on the collection of information by 
November 27, 2009.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Recordkeeping Requirements for Microbiological Testing and 
Corrective Measures for Bottled Water.'' Also include the FDA 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, e-mail: 
JonnaLynn.Capezzuto@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.

Recordkeeping Requirements for Microbiological Testing and Corrective 
Measures for Bottled Water--21 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 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.
    In the Federal Register of May 29, 2009 (74 FR 25752 ), FDA 
published a 60-day 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
                   and finished
                   product
                   testing)
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
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
                   finished
                   product only)
----------------------------------------------------------------------------------------------------------------
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.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25927 Filed 10-27-09; 8:45 am]

BILLING CODE 4160-01-S
