[Federal Register Volume 78, Number 57 (Monday, March 25, 2013)]
[Notices]
[Pages 17932-17933]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06727]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0033]


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 April 
24, 2013.

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 oira_submission@omb.eop.gov. 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:  Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 301-796-5733, domini.bean@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), 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 January 18, 2013 (78 FR 4152), FDA 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. FDA received two letters 
in response to the notice, which contained multiple comments.
    One comment suggested that laboratory quality assurance practices 
should be required for the testing of bottled water. FDA's CGMP 
regulations for bottled water in 21 CFR 129 do not specifically require 
laboratory quality assurance practices, and FDA does not have the 
specific statutory authority to require bottlers to use certified 
laboratories for water quality tests.\1\ However, the CGMP regulations 
for source water testing do require that ``[t]est and sample methods 
shall be those recognized and approved by the government agency or 
agencies having jurisdiction over the approval of the water source, and 
shall be consistent with the minimum [standard of quality] requirements 
set forth in Sec.  165.110(b) of this chapter'' (Sec.  
129.35(a)(3)(ii)). The CGMP regulations also state that

[[Page 17933]]

``[a]nalysis of the sample may be performed for the plant by competent 
commercial laboratories (e.g., Environmental Protection Agency (EPA) 
and State-certified laboratories)'' (Sec.  129.35(a)(3)(iii)). For 
product water, the regulations also state that bottled water 
manufacturers will ``[a]nalyze such samples by methods approved by the 
government agency or agencies having jurisdiction'' (Sec.  
129.80(g)(3)).
---------------------------------------------------------------------------

    \1\ U.S. Government Accountability Office (GAO), 2009. Bottled 
Water: FDA Safety and Consumer Protections Are Often Less Stringent 
Than Comparable EPA Protections for Tap Water.
---------------------------------------------------------------------------

    One comment noted that the EPA issued a final rule on February 13, 
2013, that established a maximum contaminant level for E. coli and 
stated that E. coli is a more specific indicator of fecal contamination 
and the potential presence of associated pathogen occurrence than fecal 
coliforms. FDA agrees that E. coli is an appropriate indicator of fecal 
contamination and that the presence of fecal indicators demonstrates 
the potential for the presence of fecal pathogens. FDA requires bottled 
water manufacturers to sample and analyze source water obtained from 
other than a public water system for total coliform at least once each 
week. If any coliform organisms are detected, manufacturers must 
conduct followup testing 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 as required for use in 
bottled water. Manufacturers must also analyze product water samples at 
least once a week for total coliform, and, if any coliform organisms 
are detected, they must conduct followup testing to determine whether 
any of the coliform organisms are E. coli. Product water containing E. 
coli is considered adulterated. Thus, the presence of the fecal 
indicator E. coli is the key factor for determining whether source 
water is of a safe, sanitary quality, and whether product water is 
adulterated. FDA is reviewing the EPA final rule referenced in the 
comment (National Primary Drinking Water Regulations: Revisions to the 
Total Coliform Rule, 78 FR 10269; February 13, 2013) to determine what 
actions, if any, FDA needs to take to respond to the rule.
    To the extent that the comments recommended changes to FDA's 
bottled water regulations, which can only be accomplished by 
rulemaking, the comments were outside the scope of the four collection 
of information topics on which the notice requested comments and will 
not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                                    Table 1--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Number of
              21 CFR Section                  Number of recordkeepers      records per    Total annual    Average burden per recordkeeping   Total hours
                                                                          recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.  Sec.   129.35(a)(3)(i) and           319 (bottlers subject to                   6           1,914  0.08 (5 minutes)                            153
 129.80(h).                                 source water and finished
                                            product testing).
Sec.   129.80(g) and 129.80(h)...........  95 (bottlers testing                       3             285  0.08 (5 minutes)                             23
                                            finished product only).
Sec.  Sec.   129.35(a)(3)(i) and           3 (bottlers conducting                     5              15  0.08 (5 minutes)                              1
 129.80(h).                                 secondary testing of source
                                            water).
Sec.  Sec.   129.35(a)(3)(i) and           3 (bottlers rectifying                     3               9  0.25 (15 minutes)                             2
 129.80(h).                                 contamination).
                                          --------------------------------------------------------------------------------------------------------------
    Total................................  ............................  ..............  ..............  ..................................          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 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 
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 3 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: March 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06727 Filed 3-22-13; 8:45 am]
BILLING CODE 4160-01-P