83 FR 55726 - Agency Information Collection Activities; Proposed Collection; 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 83, Issue 216 (November 7, 2018)

Page Range		55726-55728
FR Document		2018-24322

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements.

Federal Register, Volume 83 Issue 216 (Wednesday, November 7, 2018)

[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)]
[Notices]
[Pages 55726-55728]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-24322]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4130]

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.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the procedure by which both domestic and
foreign bottled water manufacturers that sell bottled water in the
United States maintain records of microbiological testing and
corrective measures, in addition to existing recordkeeping
requirements.

DATES: Submit either electronic or written comments on the collection
of information by January 7, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 7, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-4130 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recordkeeping Requirements for
Microbiological Testing and Corrective Measures for Bottled Water.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
PRAStaff@fda.hhs.gov.

[[Page 55727]]

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, including
each proposed extension of an existing 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)

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 (E. 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.
We estimate the burden of this collection of information as
follows:

Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 129.35(a)(3)(i) 319 6 1,914 0.08 (5 minutes) 153
and.
129.80(h) (bottlers subject to
both.
source water and finished.....
product testing)..............
Sec. 129.80(g) and (h) 95 3 285 0.08 (5 minutes) 23
(bottlers only subject to
finished product testing).
Sec. Sec. 129.35(a)(3)(i) 3 5 15 0.08 (5 minutes) 1
and 129.80(h) (bottlers
conducting secondary testing
of source water).
Sec. Sec. 129.35(a)(3)(i) 3 3 9 0.25 (15 2
and 129.80(h) (bottlers minutes).
rectifying contamination).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 179
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
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 E.
coli followup 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 water testing and
about three times in finished product testing and thus would need to
conduct six tests for E. coli, for a total of 153 hours of
recordkeeping. In addition, about 95 bottlers that use PWSs may find a
total coliform positive sample about three times per year in finished
product testing and thus would need to conduct three tests for E. coli,
for a total of 23 hours of recordkeeping.
We expect that three bottlers per year will test positive for E.
coli in source water and will need to take actions to rectify or
eliminate the cause of the contamination and verify that E. coli is
negative by taking five samples over a 24-hour period from the same
sampling site that originally tested positive for E.

[[Page 55728]]

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 test positive for
E. coli in source water and 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: November 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24322 Filed 11-6-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices 55727

SUPPLEMENTARY INFORMATION: Under the collection of information, including the the current good manufacturing practice
PRA (44 U.S.C. 3501–3520), Federal validity of the methodology and (CGMP) regulations for bottled water in
Agencies must obtain approval from the assumptions used; (3) ways to enhance part 129 require that source water from
Office of Management and Budget the quality, utility, and clarity of the other than a public water system (PWS)
(OMB) for each collection of information to be collected; and (4) be tested at least weekly for total
information they conduct or sponsor. ways to minimize the burden of the coliform. If any coliform organisms are
‘‘Collection of information’’ is defined collection of information on detected in the source water, the bottled
in 44 U.S.C. 3502(3) and 5 CFR respondents, including through the use water manufacturers are required to
1320.3(c) and includes Agency requests of automated collection techniques, determine whether any of the coliform
or requirements that members of the when appropriate, and other forms of organisms are E. coli. Source water
public submit reports, keep records, or information technology. found to contain E. coli is not
provide information to a third party. Recordkeeping Requirements for considered water of a safe, sanitary
Section 3506(c)(2)(A) of the PRA (44 Microbiological Testing and Corrective quality and would be unsuitable for
U.S.C. 3506(c)(2)(A)) requires Federal Measures for Bottled Water—21 CFR bottled water production. Before a
Agencies to provide a 60-day notice in 129.35(a)(3)(i), 129.80(g), and 129.80(h) bottler may use source water from a
the Federal Register concerning each source that has tested positive for E.
proposed collection of information, OMB Control Number 0910–0658— coli, a bottler must take appropriate
including each proposed extension of an Extension measures to rectify or otherwise
existing collection of information, The bottled water regulations in parts eliminate the cause of the
before submitting the collection to OMB 129 and 165 (21 CFR parts 129 and 165) contamination. A source previously
for approval. To comply with this require that if any coliform organisms found to contain E. coli will be
requirement, FDA is publishing notice are detected in weekly total coliform considered negative for E. coli after five
of the proposed collection of testing of finished bottled water, samples collected over a 24-hour period
information set forth in this document. followup testing must be conducted to from the same sampling site are tested
With respect to the following determine whether any of the coliform and found to be E. coli negative.
collection of information, FDA invites organisms are Escherichia coli (E. coli).
comments on these topics: (1) Whether The adulteration provision of the Description of Respondents: The
the proposed collection of information bottled water standard (§ 165.110(d)) respondents to this information
is necessary for the proper performance provides that a finished product that collection are domestic and foreign
of FDA’s functions, including whether tests positive for E. coli will be deemed bottled water manufacturers that sell
the information will have practical adulterated under section 402(a)(3) of bottled water in the United States.
utility; (2) the accuracy of FDA’s the Federal Food, Drug, and Cosmetic We estimate the burden of this
estimate of the burden of the proposed Act (21 U.S.C. 342(a)(3)). In addition, collection of information as follows:

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual Total
21 CFR section; activity records per burden per
recordkeepers records hours
recordkeeper recordkeeping

§§ 129.35(a)(3)(i) and ..................................................... 319 6 1,914 0.08 (5 minutes) .. 153
129.80(h) (bottlers subject to both .................................
source water and finished ..............................................
product testing) ...............................................................
§ 129.80(g) and (h) (bottlers only subject to finished 95 3 285 0.08 (5 minutes) .. 23
product testing).
§§ 129.35(a)(3)(i) and 129.80(h) (bottlers conducting 3 5 15 0.08 (5 minutes) .. 1
secondary testing of source water).
§§ 129.35(a)(3)(i) and 129.80(h) (bottlers rectifying con- 3 3 9 0.25 (15 minutes) 2
tamination).

Total ........................................................................ ........................ ........................ ........................ ............................. 179
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information organisms detected in the source water of 153 hours of recordkeeping. In
collection since our last request for test positive for E. coli are negligible. addition, about 95 bottlers that use
OMB approval, we have made no We estimate that the labor burden of PWSs may find a total coliform positive
adjustments to our burden estimate. keeping records of each E. coli followup sample about three times per year in
The current CGMP regulations already test is about 5 minutes per test. We also finished product testing and thus would
reflect the time and associated require followup testing of source water need to conduct three tests for E. coli,
recordkeeping costs for those bottlers and finished bottled water products for for a total of 23 hours of recordkeeping.
that are required to conduct E. coli when total coliform positives We expect that three bottlers per year
amozie on DSK3GDR082PROD with NOTICES1

microbiological testing of their source occur. We expect that 319 bottlers that will test positive for E. coli in source
water, as well as total coliform testing use sources other than PWSs may find water and will need to take actions to
of their finished bottled water products. a total coliform positive sample about rectify or eliminate the cause of the
We therefore conclude that any three times per year in source water contamination and verify that E. coli is
additional burden and costs in testing and about three times in finished negative by taking five samples over a
recordkeeping based on followup testing product testing and thus would need to 24-hour period from the same sampling
that is required if any coliform conduct six tests for E. coli, for a total site that originally tested positive for E.

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Document Created: 2018-11-07 00:04:52
Document Modified: 2018-11-07 00:04:52

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by January 7, 2019.
Contact		Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]
FR Citation		83 FR 55726

83 FR 55726 - Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 216 (November 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration