81 FR 8723 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 34 (February 22, 2016)

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.

[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Notices]
[Pages 8723-8724]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03549]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3655]


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) 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 March 
23, 2016.

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: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0658. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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. The adulteration provision of the 
bottled water standard (Sec.  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 (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 information 
collection are domestic and foreign bottled water manufacturers that 
sell bottled water in the United States.
    In the Federal Register of October 19, 2015 (80 FR 63228) FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of       Total
    21 CFR Section; Activity         Number of      records per      annual       Average burden per      Total
                                   recordkeepers   recordkeeper     records         recordkeeping         hours
----------------------------------------------------------------------------------------------------------------
Sec.   129.35(a)(3)(i), Sec.                 319               6        1,914  0.08 (5 minutes)              153
 129.80(h); Bottlers subject to
 source water and finished
 product testing.
Sec.   129.80(g), Sec.                        95               3          285  0.08 (5 minutes)               23
 129.80(h); Bottlers testing
 finished product only.
Sec.   129.35(a)(3)(i), Sec.                   3               5           15  0.08 (5 minutes)                1
 129.80(h); Bottlers conducting
 secondary testing of source
 water.
Sec.   129.35(a)(3)(i), Sec.                   3               3            9  0.25 (15 minutes)               2
 129.80(h); Bottlers rectifying
 contamination.
                                 -------------------------------------------------------------------------------
    Total Annual Burden.........  ..............  ..............  ...........  .......................       179
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance 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. 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. We estimate 
that the labor burden of keeping records of each test is about 5 
minutes per test. We also require followup testing of source water and 
finished bottled water products for E. coli when total coliform 
positives occur. We expect that 319 bottlers that use sources other 
than PWSs may find a total coliform positive sample about three times 
per year in source testing and about three 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

[[Page 8724]]

may find a total coliform positive sample about three times per year in 
finished product testing, for a total of 23 hours of recordkeeping. 
Upon finding a total coliform sample, bottlers will then have to 
conduct a followup test for E. coli.
    We expect 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, we expect that three 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, we estimate a total 
burden of 179 hours. We base our estimate on our experience with the 
current CGMP regulations.

    Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03549 Filed 2-19-16; 8:45 am]
 BILLING CODE 4164-01-P