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, 17932-17933 [2013-06727]

Download as PDF 17932 Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Notices (iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. C. Annual Reporting Burden The annual public reporting and recordkeeping burden for this collection of information is estimated to average up to 1,666 hours per year. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The estimated annual burden: Respondents: 1,200,000. Responses per Respondent: 1. Total number of responses: 1,200,000. Hours per Response: .0013886. Total hours per response: 1,200,000. Total Burden Hours: 1,666. Obtaining Copies Of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVCB), 1275 First Street NE., Washington, DC 20417, telephone 202–501–4755. Please cite 3090–0288, Open Government Citizen Engagement Ratings, Rankings, and Flagging, in all correspondence. mstockstill on DSK4VPTVN1PROD with NOTICES Dated: March 19, 2013. Casey Coleman, Chief Information Officer. [FR Doc. 2013–06732 Filed 3–22–13; 8:45 am] BILLING CODE 6820–34–P VerDate Mar<15>2010 17:34 Mar 22, 2013 Jkt 229001 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. 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. SUMMARY: 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 PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 water standard (§ 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 60day 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 § 165.110(b) of this chapter’’ (§ 129.35(a)(3)(ii)). The CGMP regulations also state that 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. E:\FR\FM\25MRN1.SGM 25MRN1 17933 Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Notices ‘‘[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)’’ (§ 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’’ (§ 129.80(g)(3)). 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 BURDEN1 Number of records per recordkeeper Total annual records Average burden per recordkeeping 21 CFR Section Number of recordkeepers §§ 129.35(a)(3)(i) and 129.80(h) ...... 6 1,914 0.08 (5 minutes) 153 3 285 0.08 (5 minutes) 23 5 15 0.08 (5 minutes) 1 §§ 129.35(a)(3)(i) and 129.80(h) ...... 319 (bottlers subject to source water and finished product testing). 95 (bottlers testing finished product only). 3 (bottlers conducting secondary testing of source water). 3 (bottlers rectifying contamination) 3 9 0.25 (15 minutes) 2 Total .......................................... .......................................................... ........................ ........................ § 129.80(g) and 129.80(h) ............... §§ 129.35(a)(3)(i) and 129.80(h) ...... mstockstill on DSK4VPTVN1PROD with NOTICES 1 There Total hours 179 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 VerDate Mar<15>2010 17:34 Mar 22, 2013 Jkt 229001 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. PO 00000 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0320] Determination That BENADRYL (diphenhydramine hydrochloride) Injection and Two Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that the three drug products listed in this document were not withdrawn from SUMMARY: Frm 00014 Fmt 4703 Sfmt 4703 E:\FR\FM\25MRN1.SGM 25MRN1

Agencies

[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]


=======================================================================
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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

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