0658 Supporting Statement 2016

Recordkeeping Requirements for Microbiological
Testing and Corrective Measures for Bottled Water
OMB Control No. 0910-0658
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
The U.S. Environmental Protection Agency (EPA) promulgated the National Primary Drinking
Water Regulation (NPDWR), the Ground Water Rule (GWR) (71 FR 65574; November 8,
2006), to provide for increased protection against fecal microbial pathogens in public water
systems (PWSs) that use ground water sources (also referred to as ground water systems
(GWSs)). In the GWR, EPA established treatment techniques intended to identify and target
GWSs that are susceptible to fecal contamination and require such GWSs to monitor and, when
necessary, take corrective action to prevent or remove such contamination.
Under section 410(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21
U.S.C. 349(b)(1)), when EPA issues a NPDWR for a contaminant under section 1412 of the Safe
Drinking Water Act (SDWA) (42 U.S.C. 300g-1), the U.S. Food and Drug Administration
(FDA) is required to issue a standard of quality regulation for that contaminant in bottled water
or make a finding that such a regulation is not necessary to protect the public health because the
contaminant is contained in water in PWSs but not in water used for bottled water. Section
410(b)(3) of the FD&C Act (21 U.S.C. 349(b)(3)) requires the standard of quality for a
contaminant in bottled water to be no less stringent than EPA’s maximum contaminant level
(MCL) and no less protective of the public health than EPA’s treatment technique requirements
for the same contaminant. In addition, section 410(b)(2) of the FD&C Act (21 U.S.C. 349(b)(2))
provides that a standard of quality regulation issued by FDA shall include monitoring
requirements that the agency determines to be appropriate for bottled water. In response to
EPA’s GWR and in accordance with section 410(b)(1) of the FD&C Act, FDA 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,
follow-up 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 (§ 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 FD&C Act. In addition, FDA amended the current good manufacturing
practice (CGMP) regulations for bottled water in part 129 by requiring that source water from
other than a 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 prohibited for use in production of
bottled water. 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 that
originally tested positive for E. coli are tested and found to be E. coli negative.
FDA requests the extension of OMB approval of the information collection provisions in the
following citations:
21 CFR 129.35(a)(3)(i) – Recordkeeping
Requires records of approval of the source water by government agencies having jurisdiction,
records of sampling and analyses for which the plant is responsible, and records describing
corrective measures taken in response to a finding of E. coli to be maintained on file at the plant.
21 CFR 129.80(g) – Recordkeeping
Requires the plant to maintain records of date of sampling, type of product sampled, production
code, and results of analysis.
21 CFR 129.80 (h) – Recordkeeping
Requires all records required by §§129.1, 129.20, 129.35, 129.37, 129.40, and 129.80 to be
maintained at the plant for not less than 2 years; requires plants to retain, on file at the plant,
current certificates or notifications of approval issued by the government agency or agencies
approving the plant's source and supply of product water and operations water; requires all
required documents to be available for official review at reasonable times.
2. Purpose and Use of the Information Collection
The potential exists for bottled water products from ground water sources to be contaminated
from ground water sources or during processing and for bottled water products from other
sources to be contaminated from source water or during processing. Therefore, FDA requires
that source water subject to weekly microbiological testing be analyzed specifically for total
coliform, as it is required for finished bottled water products. Further, FDA requires that if any
coliform organisms are detected in weekly total coliform testing of source water or finished
bottled water, follow-up testing must be conducted to determine whether any of the coliform
organisms are E. coli. The requirements in these regulations help ensure that bottled water is
subject to requirements no less protective of the public health than the treatment techniques
adopted by EPA in the GWR for public drinking water.
Records of microbiological testing, including testing for total coliform and follow-up testing for
E. coli when necessary, are needed to allow FDA to determine whether procedures to help
prevent the occurrence of fecal microbial pathogens in bottled water products are being carried
out in an effective manner over time. Furthermore, FDA personnel may not be present when
producers perform sampling and analysis of bottled water. These records would allow FDA to
verify that the required testing is conducted. These records would also allow FDA to confirm
that test results meet FDA’s standards and that producers are taking appropriate actions based on
the results.
Recordkeeping not only helps the agency determine whether bottled water is manufactured,
packaged, and held in a manner consistent with FDA’s bottled water regulations, but also

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provides a public health benefit to consumers. When bottled water manufacturers keep records,
for example, of lot or batch numbers, the records facilitate a bottler’s recall of suspect products
in case a recall becomes necessary. This benefits consumers because the manufacturer can recall
products that may be adulterated or misbranded more quickly.
Another requirement is that bottlers maintain records of measures taken to address a positive E.
coli finding in source water. Records of corrective measures are needed for FDA to determine
compliance with the rule’s requirement that bottlers take appropriate measures to rectify or
otherwise eliminate the cause of E. coli contamination in source water.
In summary, the records required for additional microbiological testing and for substantiation of
corrective measures provide assurance to both the bottler and FDA that the risk of contamination
of bottled water products with fecal microbial pathogens is being minimized.
3. Use of Improved Information Technology and Burden Reduction
Companies are free to use whatever forms of information technology may best assist them in
retaining the appropriate records and making them available to regulatory officials. The FD&C
Act does not specifically prescribe the use of automated, electronic, mechanical, or other
technological techniques or other forms of information technology as necessary for use by firms.
The agency estimates that about ninety percent (90%) of the records will be maintained
electronically in the next three years.
4. Efforts to Identify Duplication and Use of Similar Information
FDA is the only Federal agency that collects this information. There is no duplication of
recordkeeping requirements.
5. Impact on Small Businesses or Other Small Entities
FDA estimates that eighty percent (80%) of recordkeepers are small businesses. The SDWA
contains no statutory exception for small businesses from its provisions. The same information
is requested from large and small firms and is the minimal amount needed. FDA aids small
businesses in complying with its requirements through the agency’s Regional Small Business
Representatives and through the scientific and administrative staffs within the agency. FDA has
provided a Small Business Guide on the agency’s website at http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs weekly. FDA believes that mandatory recordkeeping is consistent with
the congressional intent of the SDWA and important for public health reasons. Less frequent
recordkeeping would reduce or nullify the effectiveness of the regulation to provide assurance to
both the bottler and FDA that source water and finished bottled water products are not
contaminated with fecal microbial pathogens.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this information collection.

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8. Comments in Response to the Federal Register Notice/Outside Consultation
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice soliciting public comment
in the Federal Register of October 19, 2015 (80 FR 63228). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
The regulation does not contain an assurance of confidentiality. The agency expects that it may
inspect firm records containing confidential commercial information. Confidential commercial
information is protected from disclosure under the Freedom of Information Act under sections
552(a) and (b) (5 U.S.C. 552(a) and (b)), and by part 20 of the agency’s regulations (21 CFR part
20). To the extent 21 CFR 20.64 applies, FDA will honor the confidentiality of any data in
investigation records compiled for law enforcement purposes.
11. Justification for Sensitive Questions
This information collection does not contain questions that are of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
Description of Respondents: Respondents to this proposed information collection are domestic
and foreign bottled water manufacturers that sell bottled water in the United States.
Recordkeepers are from the private sector (for profit businesses).
12a. Annualized Hour Burden Estimate
FDA estimates the burden for this information collection as follows:
Table 1 – Estimated Annual Recordkeeping Burden
21 CFR Section; Activity

No. of
Recordkeepers

No. of Records
per Recordkeeper

Total
Annual
Records

Avg. Burden per
Recordkeeping

Total
Hours

129.35(a)(3)(i),
129.80(h); bottlers
subject to source water
and finished product
testing
129.80(g), 129.80(h);
bottlers testing finished
product only

319

6

1,914

0.08

153

95

3

285

0.08

23

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129.35(a)(3)(i),
129.80(h); bottlers
conducting secondary
testing of source water
129.35(a)(3)(i),
129.80(h); bottlers
rectifying
contamination)
TOTAL

3

5

15

0.08

1

3

3

9

0.25

2

179

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 follow-up testing that is required if any
coliform organisms detected in the source water test positive for E. coli are negligible. FDA
estimates that the labor burden of keeping records of each test is about 5 minutes per test (0.08
hours). FDA also requires follow-up 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 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 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 follow-up test for E. coli.
FDA expects that recordkeeping for the follow-up test for E. coli will also take about 5 minutes
per test. As shown in table 1 of this document, FDA expects 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, FDA estimates a total burden of
179 hours. FDA bases its estimate on its experience with the current CGMP regulations.
12b. Annualized Cost Burden Estimate
Type of Recordkeeper

Total Burden Hours

Hourly Wage Rate

Bottlers

179

$71.76

Total Recordkeeper
Costs
$12,845.04

The annual hour cost burden to recordkeepers is approximately $12,845.04 per year. FDA
estimates that the average hourly wage for the employee retaining records would be equivalent to
a GS-12/Step-1 level in the locality pay area of Washington-Baltimore-Northern Virginia for
2013, approximately $35.88/hour. Doubling this wage to account for overhead costs, FDA
estimates the average hourly cost to recordkeepers to be $71.76/hour. Thus, the overall
estimated cost incurred by the recordkeepers is $12,845.04 (179 burden hours x $71.76/hr).

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13. Estimates of Other Total Annual Cost Burden to Respondents or Recordkeepers/Capital
Costs
There are no capital, start-up, operating, or maintenance costs associated with this collection.
14. Annualized Cost to the Federal Government
FDA’s review of the retained records would generally occur as part of an inspection. FDA
would devote approximately 5 hours per inspection to the inspection of records. FDA estimates
the annualized cost to the Federal Government for the review of records retained by a firm to be
$358.80 per review. In this calculation of cost, FDA estimates the hourly cost for review and
evaluation at a base GS-12/Step 1 salary of $35.88 per hour for the locality pay area of
Washington-Baltimore-Northern Virginia for 2013. Five hours multiplied by $35.88 per hour
equals $179.40. To account for overhead, this cost is increased by 100 percent, making the total
annualized cost to the Federal Government $358.80 per review. FDA estimates that it will
perform approximately 143 inspections per year, for a total cost of $51,308.40.
15. Explanation for Program Changes or Adjustments
The hour burden is unchanged; the program has remained constant.
16. Plans for Tabulation and Publication and Project Time Schedule
We have no plans to publish data from this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking approval to not display the expiration date for OMB approval of the
information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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