[Federal Register Volume 74, Number 102 (Friday, May 29, 2009)]
[Rules and Regulations]
[Pages 25651-25665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12494]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 129 and 165

[Docket No. FDA-2008-N-0446]


Beverages: Bottled Water

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its bottled 
water regulations to require that bottled water manufacturers test 
source water for total coliform, as is required for finished bottled 
water products, and to require, if any coliform organisms are detected 
in source water, that bottled water manufacturers determine whether any 
of the coliform organisms are Escherichia coli (E. coli), an indicator 
of fecal contamination. FDA also is amending its bottled water 
regulations to require, if any coliform organisms are detected in 
finished bottled water products, that bottled water manufacturers 
determine whether any of the coliform organisms are E. coli. FDA also 
is amending the adulteration provision of the bottled water standard to 
reflect the possibility of adulteration caused by the presence of 
filth. Bottled water containing E. coli will be considered adulterated, 
and source water containing E. coli will not be considered to be of a 
safe, sanitary quality and will be prohibited from use in the 
production of bottled water. FDA is also amending its bottled water 
regulations to require that, before a bottler can use source water from 
a source that has tested positive for E. coli, the bottler must take 
appropriate measures to rectify or eliminate the cause of E. coli 
contamination of that source, and that the bottler must keep records of 
such actions. Existing regulatory provisions require bottled water 
manufacturers to keep records of new testing required by this rule. 
This final rule will ensure that FDA's standards for the minimum 
quality of bottled water, as affected by fecal contamination, will be 
no less protective of the public health than those set by the 
Environmental Protection Agency (EPA) for public drinking water.

DATES: This rule is effective December 1, 2009. The incorporation by 
reference of certain publications listed in the rule is approved by the 
Director of the Federal Register as of December 1, 2009.

FOR FURTHER INFORMATION CONTACT: Lauren Posnick Robin, Center for Food 
Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1639.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 17, 2008 (73 FR 53775), FDA 
published a proposed rule to amend its bottled water regulations in 
parts 129 and 165 (21 CFR parts 129 and 165) to provide increased 
protection against fecal contamination in water sources used for 
bottled water and in finished bottled water products (hereafter ``the 
proposed rule'' or ``the September 17, 2008 proposal''). FDA's current 
good manufacturing practice (CGMP) regulations for the processing and 
bottling of bottled water are contained in part 129. FDA's bottled 
water standard, contained in part 165, includes standard of identity 
regulations, which define different types of bottled water (Sec.  
165.110(a)); standard of quality regulations, which establish allowable 
levels for contaminants in bottled water (Sec.  165.110(b)); required 
label statements for water of substandard quality (Sec.  165.110(c)); 
and an adulteration provision (Sec.  165.110(d)).
    FDA proposed a number of changes to part 129. FDA proposed to amend 
Sec.  129.35(a)(3)(i) to require that bottled water manufacturers that 
obtain their source water from other than a public water system (PWS) 
test their source water at least weekly for total coliform, and that 
when source water is total coliform positive, that they conduct follow-
up\1\ testing to determine whether any of the coliform organisms are E. 
coli. Further, FDA proposed to amend Sec.  129.35(a)(3)(i) to indicate 
that if source water is found to contain E. coli, then the water would 
not be considered water of a safe, sanitary quality as required by 
Sec.  129.35(a)(1). FDA also proposed in Sec.  129.35(a)(3)(i) to 
require a bottler to rectify or otherwise eliminate the cause of the E. 
coli contamination. FDA also proposed that source water previously 
found to contain E. coli would be considered negative for E. coli after 
five samples collected from the source water supply over a 24-hour 
period are tested and found to be E. coli negative. FDA proposed in 
Sec.  129.35(a)(3)(i) that bottlers maintain records of corrective 
measures taken to rectify or eliminate E. coli contamination in source 
water. FDA also proposed in Sec.  129.80(g)(1) that if any coliform 
organisms are detected in weekly total coliform testing of finished 
bottled water, that bottlers must conduct follow-up testing to 
determine whether any of the coliform organisms are E. coli. Finally, 
FDA proposed revising Sec.  129.35(a)(4)(iv) to include a reference to 
section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 342(a)(3)) as a basis for adulteration, in addition to 
section 402(a)(1) of the act.
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    \1\ In FDA's discussion, ``follow-up'' testing refers to testing 
to determine whether any of the coliform organisms detected in 
source water or finished bottled water products are E. coli.
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    FDA proposed a number of changes to part 165. FDA proposed to add 
Sec.  165.110(b)(2)(i)(B) to indicate that if E. coli is present in a 
sample of finished bottled water products, then the bottled water would 
be deemed adulterated

[[Page 25652]]

under Sec.  165.110(d). FDA also proposed to cite the multiple-tube 
fermentation (MTF) and membrane filter (MF) methods for both total 
coliform and E. coli testing in Sec.  165.110(b)(2)(ii). Finally, FDA 
proposed to amend the adulteration provision of the bottled water 
standard in Sec.  165.110(d) to reflect the possibility of adulteration 
caused by the presence of filth and to indicate that if E. coli is 
present in bottled water, then the bottled water will be deemed 
adulterated under section 402(a)(3) of the act.
    FDA issued the proposed rule in response to EPA's issuance of a new 
National Primary Drinking Water Regulation (NPDWR), the Ground Water 
Rule (GWR), in the Federal Register of November 8, 2006 (71 FR 65574). 
The new NPDWR provides for increased protection against fecal microbial 
pathogens in PWSs that use ground water sources (also referred to as 
ground water systems (GWSs)). Under section 410(b)(1) of the act (21 
U.S.C. 349(b)(1)), not later than 180 days before the effective date of 
an NPDWR issued by EPA for a contaminant under section 1412 of the Safe 
Drinking Water Act (SDWA) (42 U.S.C. 300g-1), 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. If FDA fails to take action 
within the prescribed time period in response to the NPDWR issued by 
EPA, section 410(b)(4)(A) of the act provides that EPA's NPDWR will 
apply to bottled water.

II. Summary of and Response to Comments

A. Summary of Comments

    The agency received 19 responses, each containing one or more 
comments, to the September 17, 2008, proposal. The comments were from 
trade associations, industry, a law firm, an environmental advocacy 
organization, and consumers. The comments generally supported the 
proposed rule. Some comments addressed issues that are outside the 
scope of the proposed rule (e.g., testing of water in general; testing 
for agricultural chemicals, industrial chemicals, and parasites such as 
Giardia; public disclosure of test results for contaminants other than 
E. coli; and general labeling requirements) and thus will not be 
discussed here. A number of comments suggested certain modifications to 
the proposed rule. A summary of these comments and the agency's 
responses follow.

B. Response to Comments

    (Comment 1) One comment suggested FDA make clear that when a 
bottler conducts secondary\2\ sampling of source water previously found 
to contain E. coli, the sampling should include the original site where 
the E. coli positive occurred, if there is more than one sampling site 
at the source.
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    \2\ In FDA's discussion, ``secondary'' testing refers to testing 
to determine whether a source previously found to contain E. coli 
can now be considered negative for E. coli.
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    (Response) FDA agrees that the sampling site where an E. coli 
positive occurred must be used in secondary testing to determine 
whether the source can now be considered negative for E. coli. Proposed 
Sec.  129.35(a)(3)(i) provided that source water previously found to 
contain E. coli would be considered negative for E. coli after five 
samples collected from the source water supply over a 24-hour period 
are tested and found to be E. coli negative. To eliminate any possible 
ambiguity related to the phrases ``source water'' and ``source water 
supply'' and to make clear what is required before bottlers can use 
source water from a source that has tested positive for E. coli, FDA is 
revising proposed Sec.  129.35(a)(3)(i), in pertinent part, as follows: 
``Before a bottler can use source water from a source that has tested 
positive for E. coli, the bottler must take appropriate measures to 
rectify or otherwise eliminate the cause of E. coli contamination of 
that source in a manner sufficient to prevent its reoccurrence. 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 notes that some manufacturers combine source waters from 
multiple sources. Weekly microbiological testing is required for each 
separate source in use by the plant. If E. coli is detected in one of 
these sources, secondary testing must be conducted at that same source 
and at the same sampling site that originally tested positive for E. 
coli.
    (Comment 2) One comment stated that FDA should join EPA in 
mandating sanitary surveys as an effective measure of risk reduction. 
The comment also stated that sanitary surveys can identify and 
eliminate risks or weaknesses which weekly water testing cannot, such 
as cracks in sanitary seals around wells. Finally, the comment stated 
that if the lack of a primacy program arrangement with the States is 
the real reason for the lack of a sanitary survey requirement, FDA 
should look into establishing a primacy program arrangement, such as 
having the same State agencies and inspectors, which EPA trains and 
uses to conduct sanitary surveys of public water sources, also conduct 
sanitary surveys of bottled water sources.
    (Response) FDA disagrees with this comment. Although FDA does not 
have a primacy program arrangement with States to conduct sanitary 
surveys, FDA believes that the requirement for weekly source water 
testing for total coliform (and for E. coli, should total coliform be 
detected) in this rule, combined with the existing requirement in the 
bottled water CGMP regulations for source inspection and approval, will 
ensure that FDA's standards for the minimum quality of bottled water, 
as affected by fecal contamination, will be no less protective of the 
public health than those set by EPA for public drinking water.
    While sanitary surveys may help identify potential risks for fecal 
contamination in source water, such as cracks in sanitary seals, actual 
fecal contamination of source water is identified by source water 
testing. This rule requires weekly source water testing for total 
coliform, with E. coli testing in case of a total coliform positive. In 
addition, as FDA noted in the proposed rule, FDA's CGMP regulations for 
bottled water already require in Sec.  129.35(a)(1) that product water 
be from an approved source, defined in Sec.  129.3(a) as ``a source of 
water and the water therefrom, whether it be from a spring, artesian 
well, drilled well, municipal water supply, or any other source, that 
has been inspected and the water sampled, analyzed, and found to be of 
a safe and sanitary quality according to applicable laws and 
regulations of State and local government agencies having 
jurisdiction.'' Additionally, Sec.  129.35(a)(1) specifies that the 
approved source be ``properly located, protected, and operated and 
shall be easily accessible, adequate, and of a safe, sanitary quality* 
* *'' FDA also notes that certain elements of the GWR's sanitary 
survey, as outlined by EPA (71 FR 65574 at 65577 and 65586 through 
65587), are not relevant to bottled water plants (e.g., distribution 
system surveys) or are relevant only to EPA's unique regulatory 
structure (e.g., operator compliance with State requirements), and 
therefore would not be appropriate for FDA to include in this rule.

[[Page 25653]]

    Therefore, FDA believes that the proposed requirement for weekly 
source water testing for total coliform (and for E. coli, should total 
coliform be detected), combined with the existing requirement in the 
bottled water CGMP regulations for source inspection and approval, will 
ensure that FDA's standards for the minimum quality of bottled water, 
as affected by fecal contamination, will be no less protective of the 
public health than those set by EPA for public drinking water.
    (Comment 3) A number of comments questioned the proposed 
requirements for frequency of testing of source water and/or finished 
products in part 129. Some comments suggested that EPA requires more 
samples than FDA, while citing different numbers for how many samples 
EPA requires. Another comment stated that weekly testing would not 
detect intermittent contamination, and that daily testing would be more 
appropriate, as evidenced by FDA's proposal that a source previously 
found to contain E. coli will be considered negative for E. coli after 
five samples collected from the same source water supply over a 24-hour 
period are tested and found to be E. coli negative. Several comments 
made the point that the cost of testing would be low compared with the 
cost of a disease outbreak resulting from contaminated water.
    (Response) FDA disagrees with these comments on the proposed 
requirements for the frequency of testing of source water and finished 
products. FDA does not believe that it is appropriate to compare the 
number of tests required by EPA for total coliform in PWSs to the 
number of tests required by FDA for total coliform in source and 
finished bottled water. To monitor the microbiological safety of their 
distribution systems, PWSs must take samples throughout their 
distribution systems and in a pattern that is representative of the 
distribution system. Bottled water plants do not have distribution 
systems and monitor finished bottled water products from a filling 
line. Therefore, FDA does not believe that the number of tests required 
for a PWS distribution system serving a large geographical area is 
comparable to the monitoring required for a bottled water manufacturing 
plant.
    In this rule FDA is amending its bottled water regulations to 
require that bottled water manufacturers test source water at least 
weekly for total coliform, as is required for finished bottled water 
products, and to require, if any coliform organisms are detected in 
source water, that bottled water manufacturers determine whether any of 
the coliform organisms are E. coli, an indicator of fecal contamination 
(Sec.  129.35(a)(3)(i)). By contrast, EPA requires testing of source 
water for E. coli only when triggered by a coliform positive in the 
distribution system. FDA also is amending its bottled water regulations 
to require that if any coliform organisms are detected in finished 
bottled water products, that bottled water manufacturers determine 
whether any of the coliform organisms are E. coli (Sec.  129.80(g)(1)). 
(FDA notes that weekly sampling is the minimum required under the CGMP 
regulations for bottled water, and that manufacturers should test as 
frequently as needed to ensure the safety of their products.)
    Also, FDA previously established additional microbiological testing 
requirements to help ensure the safety of finished bottled water 
products. The CGMP regulations for bottled water in Sec.  129.80(a) 
state that product water samples shall be taken after processing and 
prior to bottling by the plant and analyzed as often as is necessary to 
assure uniformity and effectiveness of the processes performed by the 
plant. FDA also requires in Sec.  129.80(f) that at least once each 3 
months, a bacteriological swab and/or rinse count should be made from 
at least four containers and closures selected just prior to filling 
and sealing. All of the samples are required to be free of coliforms, 
and no more than one of the four samples may exceed more than one 
bacteria per milliliter of capacity or one colony per square centimeter 
of surface area.
    For these reasons, FDA believes that the frequency of testing of 
source water and finished products, as set forth in the new and revised 
requirements under part 129, will ensure that FDA's standards for the 
minimum quality of bottled water, as affected by fecal contamination, 
will be no less protective of the public health than those set by EPA 
for public drinking water.
    (Comment 4) One comment stated that the requirement that bottled 
water manufacturers ``take and analyze at least once a week a 
representative sample from a batch or segment of a continuous 
production run for each type of bottled drinking water produced during 
a day's production'' in Sec.  129.80(g)(1) fails to specify that the 
day's production that is to be sampled must have been produced during 
the week in question.
    (Response) FDA believes that Sec.  129.80(g)(1) requires that the 
sample mandated to be taken ``at least once a week'' must be taken from 
bottled water produced during the week it is sampled. It would not make 
sense to interpret this provision to allow otherwise in light of the 
clear intent to mandate regular, timely testing. Further, FDA is not 
aware of any bottlers who have understood the provision as not 
requiring the sample to have been produced during the week in question. 
Therefore, FDA does not believe it is necessary to make any changes to 
Sec.  129.80(g)(1) based on this comment.
    (Comment 5) One comment suggested that FDA establish specific 
requirements, like the EPA GWR, as to how bottlers should correct E. 
coli contamination. The comment also stated that the FDA should 
consider employing EPA's various treatment options in order to ensure 
that bottlers are using methods that are known to be effective.
    (Response) FDA does not agree that it is necessary to include 
specific requirements in its regulations for rectifying or eliminating 
the cause of E. coli contamination. Bottled water manufacturers are 
responsible for ensuring that their manufacturing operations comply 
with all applicable provisions of the act and FDA's regulations for 
bottled water, including the new provision providing that source water 
found to contain E. coli is not considered water of a safe, sanitary 
quality as required for use in bottled water. As noted in the proposed 
rule (73 FR 53775 at 53780), bottlers may wish to consult with States 
or with EPA, or review EPA guidance (http://www.epa.gov/safewater/disinfection/gwr/compliancehelp.html), for advice on how to eliminate 
causes of contamination. FDA notes that, under Sec.  129.35(a)(1), 
bottled water manufacturers are responsible for using water from 
sources that have been approved by the government agency or agencies 
(e.g., State or local agencies) having jurisdiction. These government 
agencies may have helpful advice on rectifying or eliminating the cause 
of E. coli contamination at a specific source based on local 
conditions, since the cause of contamination may vary from site to 
site.
    (Comment 6) One comment suggested that FDA update the reference in 
proposed Sec.  165.110(b)(2)(ii) to the most current version of 
``Standard Methods for the Examination of Water and Wastewater.''
    (Response) FDA agrees that the most current edition should be cited 
in the final rule. In the proposed rule, FDA cited the 20th Edition of 
``Standard Methods for the Examination of Water and Wastewater.'' 
However, there is a 21st Edition of ``Standard Methods for the 
Examination of Water and

[[Page 25654]]

Wastewater.'' Therefore, FDA is revising Sec.  165.110(b)(2)(ii) to 
incorporate by reference the 21st Edition (2005) of ``Standard Methods 
for the Examination of Water and Wastewater.''
    (Comment 7) One comment suggested the need for guidance on 
demonstrating comparable results when labs are comparing other methods 
to the MTF and MF methods. The comment further recommended that an 
established or pre-agreed-upon protocol should be used to prove 
comparability.
    (Response) FDA does not believe that such guidance is necessary. As 
stated in the proposed rule (73 FR 53775 at 53782), bottlers can use 
different methods approved by the government agency or agencies having 
jurisdiction as long as their methods give comparable results to the 
methods used by FDA. Laboratories routinely adopt new analytical 
methods and have standard practices to follow for validating the 
performance of these methods and for comparing the sensitivity, 
accuracy, and precision of the new methods to currently used methods. 
These practices, along with the information provided by FDA on 
allowable levels of E. coli and total coliform (revised Sec.  
165.110(b)(2)(i)), sampling (Sec.  165.3(b)), and methodology (revised 
Sec.  165.110(b)(2)(ii)), should provide laboratories with sufficient 
information to compare different methods to those used by FDA.
    (Comment 8) Several comments recommended that FDA consider a test 
result for E. coli to be a valid ``positive'' only if it has been 
confirmed.
    (Response) FDA agrees that a presumed positive test result for E. 
coli should be confirmed. This rule cites the MTF and MF methods, which 
incorporate confirmation steps for E. coli including streaking 
presumptive E. coli positive cultures on eosin methylene blue (EMB) 
agar, selecting colonies with the typical appearance of E. coli, and 
using a series of biochemical assays or rapid identification tests to 
identify E. coli isolates (Ref. 1).
    As noted in the proposed rule, bottlers can use methods other than 
the MTF and MF methods to analyze water for total coliform and E. coli. 
However, FDA will use the MTF and MF methods when it tests source water 
or finished bottled water products. Bottlers that want to use different 
methods must ensure that their methods give comparable results. FDA 
notes that alternate methods must be capable of quantifying total 
coliform, if coliform is present, to meet the standard in Sec.  
165.110(b)(2)(i)(A). Furthermore, all methods, including those used to 
confirm presumed positive E. coli, must be methods approved by the 
government agency or agencies having jurisdiction, as required under 
Sec.  129.35(a)(3)(ii).
    (Comment 9) One comment stated that not all strains of E. coli 
bacteria are pathogenic, and therefore, water with E. coli in it is 
also not necessarily contaminated. The comment added that testing for 
specific pathogenic strains of E. coli and other intestinal parasites 
would prove more effective than general E. coli tests in determining 
whether water is contaminated.
    (Response) FDA agrees that not all strains of E. coli are 
pathogenic. However, FDA disagrees that water with E. coli in it is not 
contaminated and that testing bottled water products for specific 
pathogenic strains would be more effective than testing for generic E. 
coli. In the GWR, EPA stated that ground water is fecally contaminated 
when fecal indicators such as E. coli are present. Because E. coli is 
indicative of fecal contamination, FDA provided in the proposed rule 
that bottled water containing E. coli would be considered adulterated 
under section 402(a)(3) of the act, in that it ``consists in whole or 
in part of any filthy, putrid, or decomposed substance, or * * * is 
otherwise unfit for food.'' Because testing for generic E. coli is 
sufficient to determine whether bottled water is fecally contaminated, 
it is not necessary to require testing for specific strains.
    In addition, as noted in the GWR, while fecal indicators typically 
are not harmful when ingested, their presence demonstrates that there 
is a pathway for pathogenic viruses and bacteria to enter ground water 
sources (71 FR 65574 at 65576). Therefore, it is not necessary to test 
for specific pathogenic strains to demonstrate that there is a pathway 
for pathogenic viruses and bacteria to enter ground water sources. 
Confining testing to a few specific pathogenic strains would be less 
effective at detecting fecal contamination than the broader E. coli 
testing required by this rule. Therefore, FDA is not making changes in 
the final rule to require testing only for pathogenic strains of E. 
coli.
    (Comment 10) One comment suggested that FDA adopt EPA's maximum 
contaminant level goals (MCLGs) as enforceable standards for chemical 
and microbiological contaminants in bottled water.
    (Response) FDA notes that with the exception of fecal contaminants, 
this comment is outside of the scope of this rulemaking. MCLGs are 
unenforceable health goals established by EPA. EPA establishes 
enforceable standards for contaminants in drinking water in the form of 
maximum contaminant levels (MCLs) or treatment techniques (TTs). The 
SDWA (section 1412(b)(4) (42 U.S.C. 300g-1(b)(4))) requires EPA to set 
MCLs and TTs as close to the MCLGs as is feasible, with feasibility 
including technical and economic considerations. Section 410(b)(3)(A) 
of the act provides that an FDA regulation issued in response to an EPA 
MCL shall establish an MCL for the contaminant in bottled water which 
is no less stringent than the MCL provided in EPA's NPDWR. Likewise, 
section 410(b)(3)(B) of the act provides that an FDA regulation issued 
in response to an EPA TT shall be no less protective of the public 
health than the TT required by EPA's NPDWR. Therefore, FDA's response 
to NPDWRs is based on the legally enforceable MCLs and TTs, as provided 
for in the act.
    (Comment 11) Several comments suggested that FDA require companies 
to disclose source information on bottled water labels. One comment 
said that there are ground water sources and surface water sources that 
are fouled by fecal pollution or other contaminants, and that public 
disclosure, on the bottle label, of the precise location of the water 
withdrawal site, of potential contamination of source water, or of 
pollutants in bottled waters will provide consumers with the evidence 
on which to make the decisions to purchase the product that would best 
suit their needs and the needs of their families.
    (Response) FDA disagrees that it should require disclosure of 
source information as part of this rulemaking. FDA addressed the issue 
of source disclosure in the final rulemaking establishing a standard of 
identity for bottled water (Sec.  165.110(a)) (60 FR 57076 at 57104, 
November 13, 1995). FDA noted that under section 201(n) of the act (21 
U.S.C. 321(n)), the agency must consider whether specific water source 
labeling information is a material fact whose nondisclosure will render 
the labeling misleading. FDA concluded that the specific name of the 
source is not material to ensure the safety of the product, given the 
requirements for source approval and operation in Sec. Sec.  129.3(a) 
and 129.35(a)(1). FDA believes that the specific name of the source is 
not material to ensure the safety of the product from fecal 
contamination, in light of the requirements cited above and those added 
by this rule.
    For this reason, FDA is not making any changes in response to these 
comments.
    (Comment 12) Several comments suggested that FDA require bottled 
water companies to disclose test results for E. coli in source water 
and/or finished bottled water products to the

[[Page 25655]]

public. One comment stated that the FDA rule should include a provision 
for public notification as found in EPA tap water regulations, which 
require PWSs that use ground water to notify the public if monitoring 
samples test positive for a fecal indicator or if the appropriate water 
protection measures have not been taken in a timely manner.
    (Response) FDA disagrees that it should require companies to 
routinely disclose test results for E. coli in source water and 
finished products to the public. Routine public disclosure of source 
water testing results is not necessary because source water containing 
E. coli will not be considered to be of a safe, sanitary quality under 
revised Sec.  129.35(a)(3)(i) and thus will be prohibited from use in 
the production of bottled water under Sec.  129.35(a)(1).
    Likewise, routine public disclosure of test results for E. coli in 
finished bottled water products is not necessary because bottled water 
products that test positive for the fecal indicator E. coli are deemed 
adulterated under new Sec.  165.110(b)(2)(i)(B) and revised Sec.  
165.110(d). Adulterated products cannot be introduced or delivered for 
introduction into interstate commerce under section 301 of the act (21 
U.S.C. 331), and FDA may take enforcement action against adulterated 
products, including pursuing product seizure (section 304 of the act 
(21 U.S.C. 334)). In addition, FDA notes that its recall guidance in 21 
CFR part 7 includes recommendations for public communication of 
recalls. Therefore, the new regulations are sufficient to ensure the 
safety of bottled water products, with regard to the presence of fecal 
contamination, without requiring routine public disclosure of testing 
results. Accordingly, FDA is not making any changes in response to this 
comment to require routine public disclosure of monitoring results.
    (Comment 13) One comment requested that FDA limit the applicability 
of the proposed rule to bottled water manufacturers that use ground 
water, noting that FDA modeled its proposed rule after the EPA GWR, 
which expressly limits its application to PWSs that use ground water. 
The comment also states that if FDA intends to regulate manufacturers 
that use surface water, it should adopt the analogous provisions of 
EPA's regulations in 40 CFR part 141, subparts C and H, which were 
designed specifically for surface water PWSs, and which are based on 
filtration and disinfection requirements rather than FDA's proposed 
requirements for an E. coli-free source and regular source testing. 
This comment also stated that source testing and corrective action 
should not be required for manufacturers that use surface water, since 
EPA does not impose these requirements on surface water PWSs. As 
further support for its position, the comment argued that these 
requirements are not necessary for manufacturers that use surface water 
because E. coli are removed during treatment processes such that the 
amount of coliform in the source has no bearing on the final product. 
The comment also stated that the imposition of the corrective action 
requirements in this rule on any ``source,'' regardless of origin, 
would unfairly force manufacturers that use surface water to either 
shut down their intakes and undertake the impossible task of 
eliminating E. coli that is going to be eliminated anyway during 
treatment or, alternatively, purchase water from PWSs.
    (Response) FDA disagrees with the comment that it should apply this 
rule specifically to bottled water manufacturers that use ground water, 
that any FDA requirements for bottled water manufacturers that use 
surface water should be modeled after EPA's regulations for surface 
water PWSs, and that FDA should not adopt its own source and testing 
requirements for bottled water because EPA has different requirements 
for surface water PWSs. The application of this rule to all bottled 
water manufacturers is consistent with the adulteration provisions in 
section 402(a)(3) and (a)(4) of the act and with FDA's obligations 
under section 410 of the act. Specifically, under section 410(b)(1) of 
the act, FDA is required to respond to EPA's issuance of an NPDWR for a 
contaminant in drinking water by issuing 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(a)(b)(2) of the act also 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 this rule, FDA is responding to an EPA NPDWR on fecal 
contamination in ground water. Fecal contamination can be found in 
surface water as well as ground water. Therefore, FDA believes that it 
is appropriate for it to respond to EPA's issuance of a NPDWR on fecal 
contamination in GWSs by establishing a regulation that will apply to 
all manufacturers of bottled water. As FDA explained in the proposed 
rule, ``[T]he potential for fecal contamination addressed in the EPA 
GWR also exists for ground water sources used for bottled water. The 
potential also exists for bottled water products from ground water 
sources to be contaminated during processing and for bottled water 
products from other sources to be contaminated from source water or 
during processing. Therefore, FDA is proposing to require that source 
water currently subject to weekly microbiological testing be analyzed 
specifically for total coliform * * *.'' (73 FR 53775 at 53779 through 
53780). FDA notes that this rule is consistent with its regulatory 
approach, which has not been to establish separate regulations for 
ground water and surface water sources under parts 129 and 165.
    In response to the comment's contention that the microbiological 
source testing and rectification requirements of this rule are not 
necessary for manufacturers that use surface water because 
microbiological contaminants are removed during treatment processes, 
FDA emphasizes that all bottled water products are subject to existing 
requirements related to the water supply. FDA's CGMP regulations for 
bottled water define ``an approved source'' as ``a source of water and 
the water therefrom * * * that has been inspected and the water 
sampled, analyzed, and found to be of a safe and sanitary quality 
according to applicable laws and regulations of State and local 
government agencies having jurisdiction'' (Sec.  129.3(a)). The CGMP 
regulations require that the product water supply be of a ``safe, 
sanitary quality'' (Sec.  129.35(a)(1)). FDA does not consider source 
water containing E. coli to be of a safe and sanitary quality. The CGMP 
regulations also require at least weekly microbiological testing under 
Sec.  129.35(a)(3)(i) for source water obtained from other than a PWS. 
Therefore, sources other than PWSs that have not been sampled and 
analyzed for microbiological contaminants are not in compliance with 
FDA's CGMP regulations for source water.
    One existing exemption to the microbiological testing requirement 
is for source water from PWSs. As explained in the final rule 
establishing this exemption, PWSs are subject to EPA regulations to 
ensure the safety of public drinking water, including water from 
surface sources (60 FR 57076 at 57111). In this case, FDA considers the 
source water for bottling to be the treated water from the PWS, not the 
original surface water source from which the PWS drew its water. 
Therefore, this rule's requirement for coliform and, potentially, E. 
coli testing

[[Page 25656]]

of source water does not apply to manufacturers that obtain their 
source water from PWSs that use surface water.
    In response to concerns regarding the rule's impact on 
manufacturers that use surface water, FDA noted in the proposed rule 
that 70 to 75 percent of bottled water manufacturers use ground water 
(73 FR 53775 at 53779). FDA believes that the vast majority of the 
remaining manufacturers obtain their source water from PWSs, rather 
than from surface water sources, based on information provided by 
industry (66 FR 35439 at 35440 through 35441, July 5, 2001). FDA also 
notes that this comment did not provide any specific information 
identifying manufacturers using surface water that might be affected by 
the rule. For these reasons, FDA is unaware of evidence of any bottled 
water manufacturers using surface water directly from a surface water 
source that would be negatively affected by this rule, e.g., 
manufacturers using sources that are potentially contaminated with E. 
coli.
    For the reasons summarized above, FDA is not making changes to the 
final rule in response to this comment.

III. Conclusion

    The comments to the September 17, 2008, proposal (73 FR 53775) 
supported most of the provisions that FDA is adopting in this final 
rule. After review and consideration of the comments received in 
response to the September 17, 2008, proposal, FDA concludes that it 
should amend part 129 and part 165 as set forth in the proposed rule 
but with the specific modifications to the proposed regulation 
discussed in this document. For the purposes of this final rule, 
certain changes, in addition to those discussed in this document, were 
made for editorial purposes, clarity, and consistency only. These 
changes do not modify any matter of substance.
    Therefore, FDA is amending parts 129 and 165 to provide the 
following:
     Bottled water manufacturers that obtain their source water 
from other than a PWS must test their source water at least weekly for 
total coliform, and if that source water is total coliform positive, 
must conduct follow-up testing to determine whether any of the coliform 
organisms are E. coli (Sec.  129.35(a)(3)(i));
     Source water found to contain E. coli will not be 
considered water of a safe, sanitary quality as required for use in 
bottled water by Sec.  129.35(a)(1) (Sec.  129.35(a)(3)(i));
     Before a bottler can use source water from a source that 
has tested positive for E. coli, the bottler must take appropriate 
measures to rectify or otherwise eliminate the cause of E. coli 
contamination of that source in a manner sufficient to prevent its 
reoccurrence. 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 (Sec.  
129.35(a)(3)(i));
     Bottlers must maintain records of corrective measures 
taken to rectify or eliminate E. coli contamination (Sec.  
129.35(a)(3)(i));
     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 (Sec.  129.80(g)(1));
     Section 402(a)(3) of the act, in addition to section 
402(a)(1), may apply as a basis for adulteration (Sec.  
129.35(a)(4)(iv));
     Analyses conducted to determine compliance with the 
standards for microbiological quality for total coliform and E. coli 
must be made in accordance with the MTF and MF methods (Sec.  
165.110(b)(2)(ii)); and
     If E. coli is present in bottled water, then the bottled 
water is deemed to be adulterated under section 402(a)(3) of the act 
(Sec.  165.110(b)(2)(i)(B); Sec.  165.110(d)).
    As a result of these amendments to parts 129 and 165, upon the 
effective date of this final rule, December 1, 2009, any source water 
containing E. coli will not be considered water of a safe, sanitary 
quality and cannot be used for the production of bottled water. Also, 
any finished bottled water product that contains E. coli is deemed to 
be adulterated under section 402(a)(3) of the act.

IV. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule. No new information or 
comments have been received that would affect the agency's previous 
determination that there is no significant impact on the human 
environment and that an environmental impact statement is not required.

V. Analysis of Impacts

A. Executive Order 12866 and Regulatory Flexibility Act

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is not a significant regulatory action under the 
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the costs per entity of this rule are small, 
the agency certifies that the final rule will not have a significant 
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $130 million, using the most current (2007) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    This final economic impact analysis revises the analysis set forth 
in the proposed rule (73 FR 53775) in response to comments received. 
Except as indicated below, the analysis in this final rule is the same 
as the analysis of the proposed rule.
1. Need for Regulation
    FDA did not receive any comments on the need for regulation in the 
analysis of the proposed rule. Under section 410 of the act, FDA is 
required to respond to the GWR published by EPA by issuing its own 
standard of quality regulation for bottled water that is no less 
protective of the public health than the treatment techniques adopted 
by EPA in the GWR, unless it makes a finding that such additional 
regulations are not necessary to protect the public health. EPA 
published the GWR, in part, because data indicated that GWSs are 
susceptible to fecal contamination. Prior to the GWR, there were no 
Federal regulations requiring monitoring or disinfection of ground 
water sources or requiring corrective action when fecal

[[Page 25657]]

contamination or a risk of fecal contamination is found. The GWR puts 
in place a regulatory process, including treatment techniques, to 
identify and target GWSs that are susceptible to fecal contamination, 
and to require higher risk GWSs to monitor and, when necessary, take 
corrective action. As noted previously, if FDA fails to take action 
within the prescribed time period in response to the GWR, then under 
section 410(b)(4)(A) of the act, EPA's GWR will apply to bottled water. 
Further, section 410(b)(2) of the act requires that a standard of 
quality regulation issued by FDA shall include monitoring requirements 
that the agency determines to be appropriate for bottled water.
    EPA determined that there is the potential for ground water to be 
contaminated with pathogenic bacteria or viruses, or both, and that the 
presence of fecal indicators can demonstrate a pathway for pathogenic 
enteric bacteria and viruses to enter GWSs. Ground water sources supply 
water for 70 to 75 percent of all U.S. bottled water products (Ref. 2). 
Based on EPA's findings in the GWR, FDA concludes that the potential 
for fecal contamination that exists for PWS ground water sources 
regulated by EPA's GWR also exists for bottled water using ground water 
sources. The potential also exists for bottled water products from 
ground water sources to be contaminated during processing and for 
bottled water products from other sources to be contaminated from 
source water or during processing.
    Dun's Market Identifiers database lists 378 U.S. establishments 
under North American Industry Classification System (NAICS) code 312112 
Bottled Water Manufacturing (69 FR 70082 at 70084, December 2, 2004). 
These 378 establishments correspond to 318 firms. Because a firm may 
own more than one establishment and each establishment may be a source, 
a bottling plant or both, this analysis will assume that each 
establishment corresponds to one source. Foreign bottled water 
establishments that produce and export their bottled water products for 
consumption in the United States will have to meet the same FDA 
requirements as domestic establishments. FDA is aware of at least 35 
major brands of bottled water that are imported into the United States. 
When sales of a particular brand constitute a significant portion of 
the market share for this industry, then the brand is considered a 
major brand. If each imported brand corresponds to one foreign 
establishment, then an additional 35 foreign establishments will also 
be affected, giving a total of 413 establishments covered by this rule 
(Ref. 3). Because FDA assumes that each establishment is equivalent to 
a single water source, we estimate that 413 bottlers, both domestic and 
foreign, will be covered by this regulation. FDA received no comments 
on these estimates. However, in response to a comment on sampling after 
an E. coli positive, FDA noted that in some cases, bottlers may have 
more than one sampling site at a source or may combine water from more 
than one source for bottling. Because none of the comments provided 
information regarding the possible number of sources per bottler, for 
purposes of this analysis, FDA maintains in this final rule the one 
source to one establishment correspondence used in the cost estimates 
of the proposed rule.
2. Regulatory Options
    FDA evaluated three regulatory options in the analysis of this 
rule:
    Option 1. Take no action. If FDA fails to issue a standard of 
quality regulation or make a finding that such a regulation is not 
necessary to protect the public health, then EPA's GWR will apply to 
bottled water.
    Option 2. Issue the regulations, as outlined in Option 3, but 
remove the existing exemption for weekly microbiological testing of 
source water from PWSs.
    Option 3. Issue the regulations in this final rule. FDA is 
requiring that source water currently subject to weekly microbiological 
testing be analyzed specifically for total coliform and if any coliform 
organisms are detected in source water or in finished bottled water 
products, then bottled water manufacturers will be required to test for 
E. coli. Source water containing E. coli will not be considered to be 
of a safe, sanitary quality and will be prohibited from use in the 
production of bottled water. Before a bottler can use source water from 
a source that has tested positive for E. coli, the 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. Finished 
bottled water products containing E. coli will be deemed adulterated.
    Several comments recommended that FDA consider an E. coli test 
result to be ``positive'' only if it has been confirmed so it is 
considered valid. In response, FDA pointed out that the test methods 
specified in the rule include confirmatory steps.
    In evaluating the testing costs of the proposed rule, FDA based its 
estimates on EPA's GWR estimates for testing costs. At least some of 
the methods approved by EPA in the GWR include confirmatory testing for 
the fecal indicator organism. Therefore the costs of confirmatory 
testing are already included in the overall testing cost estimates used 
by EPA. Thus, the estimated testing costs in the economic impact 
analysis of the proposed rule remain the same for the economic impact 
analysis of this final rule.

Costs and Benefits of Options

    Option 1. Take no action. If FDA does not issue a regulation by the 
statutory deadline, EPA's GWR for drinking water would become 
applicable to bottled water. EPA's GWR is designed for PWSs, which 
differ in significant ways from bottled water plants. Some of its 
provisions, such as those that address public water distribution 
systems, cannot be applied literally to bottled water plants, which do 
not have such distribution systems. Accordingly, FDA believes that 
Option 1 is not efficient and therefore less desirable than the chosen 
option.
    Option 2. Change the testing requirements for source water and 
finished bottled water products to include total coliform testing of 
source water for all bottlers (i.e., remove the existing exemption for 
weekly microbiological testing of source water from PWSs) and require 
follow-up testing for E. coli when total coliform positives occur.
    Bottlers that obtain their water from PWSs are not required to 
conduct microbiological testing of their source water under the CGMPs 
(Sec.  129.35(a)(3)(i)). FDA considered removing this exemption. This 
would have the advantage of requiring all bottlers to conduct the same 
tests (i.e., to test their source water for total coliform) and to 
conduct follow-up testing for E. coli when total coliform positives 
occur. However, removing the exemption for weekly microbiological 
testing of source water would be inefficient because PWSs are already 
covered by EPA drinking water regulations, including the GWR.
    Option 3. FDA's Final Regulatory Action. Each requirement of FDA's 
regulatory action is evaluated separately in the following order:
    1. Require that source water currently subject to weekly 
microbiological testing be analyzed specifically for total coliform;

[[Page 25658]]

    2. Require follow-up testing for E. coli when total coliform 
positives occur in source water or finished bottled water products; and
    3. Require bottlers, in the event the source water tests positive 
for E. coli, to rectify or otherwise eliminate the cause of 
contamination of the source, and then subsequently test samples from 
the same sampling site sufficiently until the source is considered 
negative for E. coli. Finished bottled water products that test 
positive for E. coli will be deemed adulterated.

Option 3 Explained

    1. Require that source water currently subject to weekly 
microbiological testing be analyzed specifically for total coliform. 
The bottled water CGMPs at Sec.  129.35(a)(3)(i) require that bottlers 
that obtain source water from other than a PWS conduct microbiological 
tests at least once a week. The CGMPs do not specify what organism to 
test for or the allowable level of bacterial contamination. FDA is now 
requiring that bottlers that obtain their water from other than a PWS 
must test their source water at least once a week for total coliform. 
FDA expects that most bottlers currently use total coliform testing to 
conduct these microbiological tests. For example, the Model Code of the 
International Bottled Water Association (IBWA), a trade association 
representing a large segment of the bottled water industry, requires 
total coliform testing of source water (Ref. 4). Furthermore, the 35 
foreign producers mentioned in this analysis are members of IBWA. 
Because microbiological testing is already a requirement of the 
existing CGMPs and total coliform testing is a widely used test for 
microbiological quality of water, and because producers are already 
required to test for total coliform in finished products, FDA expects 
that the number of establishments affected by this requirement will be 
negligible and no additional costs are estimated for this provision.
    2. Require follow-up testing for E. coli when total coliform 
positives occur in source water or finished bottled water products. As 
noted previously, FDA is requiring that bottlers that obtain their 
water from other than a PWS test their source water at least weekly for 
total coliform. Finished water products are already required to be 
tested for total coliform under the existing CGMPs. FDA is now 
requiring that if any coliform organisms are detected in source water 
or in finished water products, then the bottler must conduct follow-up 
testing for E. coli. The presence of any coliform indicates that the 
water may contain E. coli, an indicator of fecal contamination. 
Further, FDA agrees with EPA's conclusions that ground water sources 
may be vulnerable to fecal contamination and that such fecal 
contamination may pose a threat to health. Because ground water is the 
source water for approximately 75 percent of U.S. bottled water 
products, the potential for fecal contamination also exists for ground 
water sources used for bottled water. The potential also exists for 
finished bottled water products, whether from ground water sources or 
from other sources such as PWSs, to be contaminated during processing. 
FDA has determined that it is appropriate to require E. coli testing in 
response to a total coliform positive finding from weekly source and 
finished bottled water sampling. In this final rule, FDA estimates the 
costs of E. coli testing resulting from a total coliform positive. The 
estimated costs are based on the probability that the source water or a 
finished product will test positive for total coliform during any given 
year.
    3. Require bottlers, in the event the source water tests positive 
for E. coli, to rectify or otherwise eliminate the cause of 
contamination of the source, and then subsequently test samples from 
the same sampling site sufficiently until the source is considered 
negative for E. coli. Finished bottled water products that test 
positive for E. coli will be deemed adulterated. If source water tests 
positive for E. coli, this cost model assumes that bottlers will 
respond by taking action to rectify or eliminate the cause of the 
contamination, by keeping records of those actions, and by subsequently 
testing samples from the same sampling site sufficiently until the 
source is considered negative for E. coli. The source 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.
    Finished bottled water products that test positive for E. coli will 
be deemed adulterated under section 402(a)(3) of the act and revised 
Sec.  165.110(d) of the regulations. Costs to rectify or otherwise 
eliminate the cause of contamination in finished bottled water products 
are not estimated in this analysis.

Per Sample Testing Costs for E. coli

    For purposes of this analysis, FDA assumes that 75 percent of 
domestic bottled water establishments obtain their water directly from 
sources other than a PWS and that the other 25 percent obtain their 
water from PWSs (66 FR 35439 at 35440 through 35441). FDA is assuming 
that all 35 foreign producers that export bottled water to the United 
States obtain their water from other than a PWS and are currently 
testing their sources for total coliform. As mentioned previously, FDA 
assumes that for all domestic and foreign producers, one establishment 
corresponds to one source. Thus, we estimate that 284 (75 percent) of 
378 domestic establishments and all 35 foreign bottled water 
establishments (284 + 35 = 319) whose products are consumed in the 
United States obtain their water from other than a PWS. Based on this 
estimate, we further surmise that all 319 establishments are already 
conducting total coliform testing of their source water. And 
approximately 25 percent of the estimated total of 378 domestic bottled 
water establishments (approximately 95) obtains their water from a PWS.
    Table 1 of this document covers E. coli testing costs per sample. 
The estimates of the laboratory fees and testing costs are derived from 
the GWR (Ref. 5). EPA estimated the national average testing costs per 
sample for E. coli based on 25 to 100 tests conducted annually. The 
estimated costs per sample can vary depending on whether the test is 
conducted in-house or at a commercial laboratory.

                                                       Table 1.--E. coli Testing Costs per Sample
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Labor Hours                    Labor Hours
             Laboratory Type                Hourly Labor     for Sample    Cost of Sample    for Sample      Analysis       Per Sample      Total Costs
                                                Cost         Collection      Collection       Analysis       Materials     Analysis Cost    per Sample
--------------------------------------------------------------------------------------------------------------------------------------------------------
In-house                                          $ 21.44             0.5         $ 10.72            0.5          $ 8.95         $ 19.67         $ 30.39
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commercial                                        $ 21.44             0.5         $ 10.72            0           $ 74.80         $ 74.80         $ 85.52
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 25659]]

    For in-house laboratories, the laboratory materials cost per sample 
is estimated to be $8.95 and the labor cost to be $21.44 for 1 labor 
hour per sample (one-half hour for collecting and handling the sample 
and another half hour for conducting the analysis). For an independent 
commercial laboratory analysis, the test cost per sample would include 
a shipping and commercial analysis fee of $74.80 and a labor cost of 
one-half hour to collect the sample and arrange for delivery to the 
laboratory.
    FDA is not aware of how many potentially affected establishments 
will either use in-house testing facilities or outsource testing to 
commercial laboratories. For the purpose of this analysis, FDA assumes 
that all large bottlers will use in-house testing facilities and that 
either 50 percent (low-cost assumption) or 100 percent (high-cost 
assumption) of small bottled water establishments will outsource their 
testing. According to the Small Business Administration's definition of 
small business for this industry, about 82 percent of bottled water 
establishments are defined as small (69 FR 70082 at 70088). This may 
overestimate the number of bottlers that will outsource testing and 
thus may overestimate the cost of the rule. FDA did not receive any 
significant comments on this section.
    Table 2 of this document shows the breakdown of bottlers by the 
low-cost and high-cost testing models, based on laboratory choice and 
an 82-percent small business rate. For the 319 bottlers using other 
than a PWS source, either 188 bottlers (59 percent) will use in-house 
testing facilities and 131 bottlers (41 percent) will use commercial 
laboratories or 57 bottlers (18 percent) will use in-house testing 
facilities and 262 bottlers (82 percent) will use commercial 
laboratories. For the 95 bottlers using PWS sources, either 56 bottlers 
(59 percent) will use in-house testing facilities and 39 bottlers (41 
percent) will use commercial laboratories or 17 bottlers (18 percent) 
will use in-house testing facilities and 78 bottlers (82 percent) will 
use commercial laboratories.

Table 2.--High-Cost and Low-Cost Assumptions About the Number of Bottled
  Water Establishments Using Either In-House or Commercial Laboratories
------------------------------------------------------------------------
                 Number of Bottlers Using     Number of Bottlers Using a
                  Pther Than a PWS Source             PWS Source
              ----------------------------------------------------------
                  Low Cost      High Cost       Low Cost      High Cost
------------------------------------------------------------------------
In-house       188 (59%)      57 (18%)       56 (59%)       17 (18%)
 laboratory
------------------------------------------------------------------------
Commercial     131 (41%)      262 (82%)      39 (41%)       78 (82%)
 laboratory
------------------------------------------------------------------------
               319            319            95             95
------------------------------------------------------------------------

Total Coliform Frequency Estimates

    To estimate the number of samples that are likely to test positive 
for total coliform each year, FDA assumes that the frequency of total 
coliform positive samples is proportional to EPA's total coliform 
positive frequency estimates (Ref. 6). FDA did not receive any comments 
on this section.
    EPA's total coliform positive frequency estimates are dependent on 
the probability of a total coliform positive, which is dependent on the 
annual number of samples tested, which varies by system size. FDA 
requirements include at least weekly testing for total coliform in 
source water and finished products, or at least 52 source water samples 
and 52 finished product samples per year. For example, bottlers whose 
source is other than a PWS will have to test their source water at 
least once a week and also their finished product at least once a week. 
Bottlers whose source is a PWS are only required to test their finished 
product. (For this model, FDA assumes that each bottler is testing one 
type of finished product.) EPA found that the frequency rate for total 
coliform positives in ground water PWSs testing between 31 and 82 
samples for total coliform each year, ranged between 0.22 and 3 samples 
per year per system (Ref. 6). FDA assumes that the same frequency rates 
are applicable to bottled water plants testing 52 samples a year, thus 
the expected annual frequency rate of total coliform positive samples 
per bottled water source is at most 3 per year. FDA further assumes 
that the annual frequency of a total coliform positive for finished 
product testing is also at most three per bottler. For example, 
bottlers that are conducting total coliform tests for both their source 
and finished product can expect to find three total coliform positives 
from their source and three total coliform positives in their finished 
product or a total of six total coliform positive samples per year. 
This means that they will need to conduct six tests for E. coli in 1 
year. Bottlers whose sources are PWSs and are only required to conduct 
total coliform tests of their finished products can expect three 
positive samples per year. Combining this information, table 3 of this 
document shows E. coli testing costs for source water and finished 
bottled water products.

                               Table 3.--Costs of Testing Source Water and Finished Bottled Water Products for E. coli\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            A                        B                        C              (A X B X 6) + ( A X C X 3)
                                                --------------------------------------------------------------------------------------------------------
                                                                             Number of Bottlers
                                                                            Testing Both Source       Number of Bottlers
                                                     Cost per Sample         Water and Finished     Testing Only Finished     Total Annual Costs of E.
                                                                            Product (Six Tests/     Product (Three Tests/           coli Testing
                                                                                   Year)                    Year)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Low-cost assumption
  In-house laboratory                                                $30                      188                       56                       $39,000
  Commercial laboratory                                              $86                      131                       39                       $77,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total low-cost assumption                                                                                                                       $116,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 25660]]

 
High-cost assumption
  In-house laboratory                                                $30                       57                       17                       $12,000
  Commercial laboratory                                              $86                      262                       78                      $154,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total high-cost assumption                                                                                                                      $166,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Estimates are not exact due to rounding.

    Source water that tests positive for E. coli will not be considered 
to be of a safe and sanitary quality for bottling, as required in Sec.  
129.35(a)(1), and finished products that test positive for E. coli will 
be considered adulterated under section 402(a)(3) of the act and 
revised Sec.  165.110(d) of the regulations.
    A bottler could not use source water from a source found to contain 
E. coli for production of bottled water until the bottler has rectified 
or otherwise eliminated the cause of the contamination of the source, 
and has subsequently sufficiently tested samples from the same sampling 
site until the source can be considered negative for E. coli. 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.
    This cost model assumes that bottlers will take action to rectify 
or eliminate the cause of contamination based on the first positive E. 
coli sample. Thus, the estimated number of bottlers that will find an 
E. coli positive sample per year will be equal to the estimated number 
of bottlers that will take action to rectify contamination each year. 
To estimate the number of establishments that are likely to take action 
to rectify contamination, FDA relied on EPA's estimate of the 
percentage of PWSs that use ground water sources with identified 
deficiencies (Ref. 7). EPA's estimate in turn was based on survey data 
from the Association of State Drinking Water Administrators (ASDWA 
1997). FDA lacks better or more recent data. Establishments that have 
significant deficiencies or that detect fecal contamination are 
required to take corrective actions under the GWR. The survey responses 
indicated that 17 percent of systems had wells that were not 
constructed according to State regulations. FDA uses this percentage as 
an estimate of the number of systems that will have an E. coli positive 
result in source or product water over a 25-year period. EPA's cost 
model assumes deficiencies occur equally beginning in year 4 through 25 
(22 years) of the analysis, which translates into 0.77 percent of all 
GWSs taking a corrective action each year over a 22-year period. Thus, 
of the 319 bottling establishments that use sources other than PWSs, 
about 53 (17 percent) are likely to take corrective action as a result 
of an E. coli finding in a 22-year period. This translates to 2.5 
bottlers every year. For its analysis, FDA also assumes that each of 
these 2.5 bottlers will incur an E. coli positive finding only once in 
a given year. Table 4 of this document summarizes these estimates.

  Table 4.--Number of Bottlers That Incur an E. coli Positive in Source
                  Water and Must Rectify Contamination
Number of bottlers that use sources other than a PWS                 319
------------------------------------------------------------------------
Fraction of bottlers with potential source water                  0.0077
 contamination (17 percent/22 years)
------------------------------------------------------------------------
Number of bottlers that must rectify contamination each              2.5
 year over a 22-year period
------------------------------------------------------------------------

    As stated earlier, a source 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 negative. Therefore the number of bottlers that will 
test five more source samples after taking some type of action to 
rectify contamination is also 2.5. Assuming this secondary testing is 
conducted in-house or in a commercial laboratory, total annual costs of 
testing five additional samples for E. coli is estimated to be either 
$380 or $1,069 per year. Table 5 of this document summarizes these 
estimates.

  Table 5.--Total Annual Costs of Testing Five More Samples for E. coli
                       After a Positive Finding\1\
------------------------------------------------------------------------
                         A                  B              A X B X 5
                --------------------------------------------------------
                                                          Total Annual
                                        Number of       Costs of Testing
                  Cost per Sample    Bottlers Testing   Five Samples for
                                       Source Water         E. coli
------------------------------------------------------------------------
In-house                       $30                2.5               $380
 laboratory
------------------------------------------------------------------------
Commercial                     $86                2.5             $1,069
 laboratory
------------------------------------------------------------------------
\1\ Estimates are not exact due to rounding.

Costs to Rectify Contaminated Sources

    As noted previously, FDA requires bottlers to rectify or otherwise 
eliminate the cause of contamination of a source before source water 
can be used from that source. FDA drew on EPA's Economic Impact 
Analysis of the GWR to provide estimates for costs of rectifying or 
eliminating contamination.

[[Page 25661]]

EPA estimated costs using a high- and low-cost distribution. The low-
cost scenario assumes a greater percentage (60 percent) of systems with 
significant deficiencies will have less expensive (low-cost) 
deficiencies to correct. The high-cost scenario assumes a greater 
percentage of systems will have more expensive (high-cost) deficiencies 
to correct. EPA provides examples of a low-cost deficiency (replacing a 
sanitary well seal) and a high-cost deficiency (rehabilitating an 
existing well) (Ref. 7). Unit costs for these repairs are based on the 
Technology and Cost Documents for the Final GWR (Ref. 8) and appear 
here in table 6 of this document. EPA expects that the costs of these 
significant deficiencies represent the range of costs that 
establishments would be expected to incur although there are many other 
corrective actions that could be taken. For example, drilling a new 
well or purchasing water from a different supplier could be done but in 
most cases would probably be more expensive than the options listed 
earlier.
    Based on EPA's assumptions, FDA estimates one-time costs to 
bottlers of rectifying contamination range from approximately $17,000 
to $22,000 each year.

                     Table 6.--Estimated Annual Costs of Rectifying Contaminated Sources\1\
----------------------------------------------------------------------------------------------------------------
                                                                                  Number of
                                                                                Bottlers That     Total Annual
                                                                Distribution   Will Rectify a       Costs of
                    Action                        Unit Cost      of Actions     Contaminated       Rectifying
                                                                                 Source Each      Contaminated
                                                                                    Year            Sources
----------------------------------------------------------------------------------------------------------------
Replace a sanitary well seal                           $3,627             .60             2.5             $5,441
----------------------------------------------------------------------------------------------------------------
Rehabilitate an existing well                         $11,986             .40             2.5            $11,986
----------------------------------------------------------------------------------------------------------------
Total costs assuming a low-cost distribution (rounding up)                                               $17,427
----------------------------------------------------------------------------------------------------------------
Replace a sanitary well seal                           $3,627             .40             2.5             $3,627
----------------------------------------------------------------------------------------------------------------
Rehabilitate an existing well                         $11,986             .60             2.5            $17,979
----------------------------------------------------------------------------------------------------------------
Total costs assuming a high-cost distribution (rounding up)                                              $21,606
----------------------------------------------------------------------------------------------------------------
\1\ Estimates are not exact due to rounding.

    Based on discussions with experts, EPA suggests that still other 
corrective actions such as fencing off or limiting access to protective 
wells could actually cost less than the two options listed previously 
from their model (Ref. 7).
    In addition to the costs of a sanitary well or the costs of 
rehabilitating an existing well, other potential costs could include 
product loss, temporarily shutting down the operation, or changing to 
an alternate source. FDA did not receive any comments on this section.

Recordkeeping Costs

    Under this final rule, those bottlers that are required to test 
their source water and finished bottled water products at least weekly 
for total coliform (and for E. coli if any coliform organisms are 
detected) will be required to maintain records of the microbiological 
test results and corrective measures taken in response to a finding of 
E. coli for at least 2 years under revised Sec.  129.35(a)(3)(i), as 
well as current Sec.  129.80(g) and (h) of the CGMP regulations. The 
existing 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 
concludes that any additional costs in recordkeeping based on the new 
testing requirements for source water and finished bottled water 
products would be negligible.

Summary of Costs

    Total costs for this final rule, including the estimated annual 
costs for E. coli testing and for rectifying contaminated sources, are 
shown in tables 7 through 11 of this document. Annual testing costs are 
estimated as either low or high costs depending on the number of 
bottlers that use either in-house testing laboratories or outsource 
testing to commercial laboratories. Costs of rectifying contaminated 
sources are estimated using the low- and high-cost distribution from 
EPA's Economic Impact Analysis of the GWR.
    FDA estimates that 95 establishments that use PWSs are likely to 
find a total coliform positive three times a year in their finished 
product and thus will incur testing costs for E. coli three times a 
year as shown in table 7 of this document. Of the 95 bottlers that use 
PWS sources in table 7, either 56 bottlers (59 percent) will use in-
house testing facilities at $30 per sample and 39 bottlers (41 percent) 
will use commercial laboratories at $86 per sample totaling 
approximately $15,000 under the low-cost assumption, or about 17 
bottlers (18 percent) will use in-house testing facilities at $30 per 
sample and 78 bottlers (82 percent) will use commercial laboratories at 
$86 per sample costing about $21,000 under the high-cost assumption.

Table 7.--Estimated Total Annual and Discounted E. coli Testing Costs to
                        Bottlers That Use PWSs\1\
------------------------------------------------------------------------
                                                        Discounted Costs
    Total E. coli Testing Costs        Annual Costs      (20 years at 7
                                                            percent)
------------------------------------------------------------------------
Number of bottlers with PWS source  .................  .................
 = 95
------------------------------------------------------------------------
Total cost of finished product                $15,000           $160,000
 testing (low-cost assumption)
------------------------------------------------------------------------

[[Page 25662]]

 
Total cost of finished product                $21,000           $230,000
 testing (high-cost assumption)
------------------------------------------------------------------------
\1\ Estimates are not exact due to rounding.

    FDA estimates that 319 establishments that use sources other than 
PWSs are likely to find a total coliform positive about six times a 
year (three times in their source and three times in their finished 
product) and therefore, will incur testing costs for E. coli six times 
a year as shown in table 8 of this document. Of the 319 bottlers that 
obtain their water from other than a PWS, 188 bottlers (59 percent) 
will use in-house testing facilities at $30 per sample and 131 bottlers 
(41 percent) will use commercial laboratories at $86 per sample 
totaling approximately $101,000 under the low-cost assumption, and 
about 57 bottlers (18 percent) will use in-house testing facilities at 
$30 per sample and 262 bottlers (82 percent) will use commercial 
laboratories at $86 per sample costing about $145,000 under the high-
cost assumption.

Table 8.--Estimated Total Annual and Discounted E. coli Testing Costs to
              Bottlers That Use Sources Other Than PWSs\1\
------------------------------------------------------------------------
                                                        Discounted Costs
       E. coli Testing Costs           Annual Costs      (20 years at 7
                                                            percent)
------------------------------------------------------------------------
Number of Bottlers = 319            .................  .................
------------------------------------------------------------------------
Total costs of source and finished           $101,000         $1 million
 product testing (low-cost
 assumption)
------------------------------------------------------------------------
Total costs of source and finished           $145,000       $1.5 million
 product testing (high-cost
 assumption)
------------------------------------------------------------------------
\1\ Estimates are not exact due to rounding.

    Of the 319 establishments that obtain their water from other than a 
PWS, it is likely that 2.5 establishments will test positive for E. 
coli annually over 22 years and may need to take corrective action and 
conduct secondary testing. Estimated costs to rectify the cause of 
contamination using low- and high-cost assumptions appear in table 9 of 
this document.

    Table 9.--Estimated Total Annual and Discounted Costs to Rectify
                            Contamination\1\
------------------------------------------------------------------------
                                                            Discounted
                                                             Costs (20
     Costs to Rectify Contamination        Annual Costs     years at 7
                                                             percent)
------------------------------------------------------------------------
Number of bottlers = 2.5                  ..............  ..............
------------------------------------------------------------------------
Total costs to rectify contamination             $17,000       $ 185,000
 (low cost)
------------------------------------------------------------------------
Total costs to rectify contamination             $22,000       $ 230,000
 (high cost)
------------------------------------------------------------------------
\1\ Estimates are not exact due to rounding.

    Secondary testing costs are shown in table 10 of this document and 
illustrate costs for bottlers that will use either in-house or 
commercial laboratories.

Table 10.--Estimated Total Annual and Discounted Secondary Testing Costs
                               for E. coli
------------------------------------------------------------------------
                                                            Discounted
                                                             Costs (20
              Testing Costs                Annual Costs     years at 7
                                                             percent)
------------------------------------------------------------------------
Number of bottlers                                   2.5             2.5
------------------------------------------------------------------------
Total costs of five additional tests if             $380          $4,000
 using in-house laboratory
------------------------------------------------------------------------
Total costs of five additional tests if           $1,069         $11,000
 using commercial laboratory
------------------------------------------------------------------------


[[Page 25663]]

    Table 11 of this document shows the estimated total annual costs of 
this final rule (Option 3) by adding tables 7, 8, 9, and 10 to be 
$134,000 (low cost) and $189,000 (high cost). The estimated total 
discounted or present value costs (using a 7-percent interest rate over 
a 20-year period) are $1.4 million (low) and $1.9 million (high).

  Table 11.--Estimated Total Annual and Discounted Costs of Final Rule
------------------------------------------------------------------------
                                                                Total
                                                             Discounted
                                              Total Annual    Costs of
                                                Costs of     Final Rule
                                               Final Rule   (20 years at
                                                             7 percent)
------------------------------------------------------------------------
Low cost                                          $134,000  $1.4 million
------------------------------------------------------------------------
High cost                                         $189,000  $1.9 million
------------------------------------------------------------------------

Benefits

    FDA is not aware of any outbreaks or enforcement actions associated 
with fecal pathogens in bottled water in the United States in the last 
10 years. Therefore, we are not able to quantify any public health 
benefits of this option.
    However, while FDA is not aware of any recent outbreaks associated 
with fecal pathogens in bottled water, this does not mean that such 
outbreaks could never occur. Under the current FDA regulations, the 
potential exists for fecal pathogens in ground water to be undetected 
and be distributed to consumers in bottled water and cause illness. 
Testing for the fecal indicator E. coli, if total coliform is present, 
and prohibiting E. coli-contaminated water from being used as source 
water or product water, would reduce this potential.
    By issuing this regulation, FDA will ensure that FDA's standards 
for the minimum quality of bottled water, as affected by fecal 
contamination, will be no less protective of the public health than 
those set by EPA for public drinking water.

B. Small Entity Analysis

    FDA examined the economic implications of this final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires us to analyze 
regulatory options that would lessen the economic effect of the rule on 
small entities. The Small Business Administration's definition of a 
small business for NAICS code 312112 Bottled Water Manufacturing is an 
entity with 500 or fewer employees. Under this definition, 82 percent 
of the bottled water firms (260 of 318) in the Dun's Market Identifiers 
database are identified as small firms (69 FR 70082 at 70088). Assuming 
that 82 percent of total annual costs shown in table 11 of this 
document will be incurred by small firms, and that 92 percent of the 
small firms are domestic, then total annual domestic costs of $100,000 
to $140,000 will be incurred by the 260 small firms. However, because 
it is possible that a firm may not find a total coliform positive in 
any year during a 20-year period, subsequent testing for E. coli or 
taking action to rectify contamination would not be needed and thus, 
average estimated annual costs per firm can be as low as $380. Average 
estimated annual costs per firm can be as high as $540 because it is 
also possible for a firm to incur costs to rectify contamination in any 
given year over a 20-year period as a result of finding total coliform 
and E. coli positives. This rule will affect a substantial number of 
small bottled water manufacturers. Although the number of small 
bottlers affected is large, the average annual costs per business are 
small. The annual average cost per small bottler (weighted by 
requirement costs) is summarized in table 12 of this document.

        Table 12.--Weighted Average Annual Costs per Small Entity
------------------------------------------------------------------------
                                           Weighted Average Annual Costs
                                                    per Entity
      Annual Costs per Requirement       -------------------------------
                                             Low Cost        High Cost
------------------------------------------------------------------------
Number of small firms = 260
------------------------------------------------------------------------
E. coli testing of source water and                 $285            $407
 finished products
------------------------------------------------------------------------
E. coli testing finished products only               $50             $70
------------------------------------------------------------------------
E. coli secondary testing                             $1              $3
------------------------------------------------------------------------
Costs to rectify contamination                       $50             $60
------------------------------------------------------------------------
Average costs per bottler                           $380            $540
------------------------------------------------------------------------

    To investigate the potential significance of these impacts, FDA 
entered these costs into a model created under contract by the Eastern 
Research Group (ERG) (Ref. 9). The model is designed to estimate the 
percentage of small firms that would go out of business because of 
compliance costs if those costs accrued to all small firms in a given 
industry. According to this model, an annual cost of $380 to $540 would 
generate a near zero percent probability that a small firm with less 
than 20 employees that faced those costs would go out of business. 
Because the costs per entity of this rule are small, the agency 
concludes that this final rule will not have a significant economic 
impact on a substantial number of small entities. FDA did not receive 
any comments on this section.

VI. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Comments on 
the information collection provisions of this final rule are being 
solicited in a separate notice published elsewhere in this issue of the 
Federal Register. Prior to the effective date of this final rule, FDA 
will publish a notice in the Federal Register announcing OMB's decision 
to approve, modify, or disapprove the information collection provisions 
in this final rule. An agency may not conduct or sponsor, and a person 
is not required to respond to, a collection of information unless it 
displays a currently valid OMB control number.

[[Page 25664]]

VII. Federalism\3\
---------------------------------------------------------------------------

    \3\ As stated in the Background section of this document, if FDA 
fails to take action within the prescribed time period in response 
to the NPDWR issued by EPA, EPA's NPDWR will apply to bottled water. 
On May 20, 2009, President Obama issued a Memorandum for the Heads 
of Executive Departments and Agencies on preemption. FDA will 
analyze this rule in light of the President's Memorandum and will 
amend the rule if needed to reflect the express preemption provision 
in section 403A(a) of the act.
---------------------------------------------------------------------------

    FDA has analyzed this rule in accordance with the principles set 
forth in Executive Order 13132. Section 4(a) of the Executive Order 
requires agencies to ``construe * * * a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.''
    Section 403A of the act (21 U.S.C. 343-1) is an express preemption 
provision. Section 403A(a) of the act provides that: ``* * * no State 
or political subdivision of a State may directly or indirectly 
establish under any authority or continue in effect as to any food in 
interstate commerce--(1) any requirement for a food which is the 
subject of a standard of identity established under section 401 that is 
not identical to such standard of identity or that is not identical to 
the requirement of section 403(g) * * *.'' FDA has interpreted this 
provision to apply to standards of quality (21 CFR 100.1(c)(4)).
    FDA has determined that the revisions to the standard of quality 
for bottled water relating to microbiological quality (Sec.  
165.110(b)(2)) will have a preemptive effect on State law. Although 
this rule has a preemptive effect in that it will preclude States from 
issuing requirements for microbiological testing in bottled water that 
are not identical to the requirements for microbiological testing in 
bottled water as set forth in this rule, this preemptive effect is 
consistent with what Congress set forth in section 403A of the act. 
Section 403A(a)(1) of the act displaces both State legislative 
requirements and State common law duties (Riegel v. Medtronic, 128 S. 
Ct. 999 (2008)).

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852 and may be seen by interested persons between 9 a.m. and 4 
p.m., Monday through Friday. (FDA has verified all Web site addresses, 
but FDA is not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)
    1. Bacteriological Analytical Manual (BAM) Online. September 
2002. Chapter 4: Enumeration of Escherichia coli and the Coliform 
Bacteria. Accessed online at http://www.cfsan.fda.gov/~ebam/bam-
4.html.
    2. International Bottled Water Association, 2007. Personal 
communication. August 30, 2007.
    3. Skipton, Hay, Albrecht, ``Drinking Water: Bottled or Tap?'' 
University of Nebraska of Nebraska-Lincoln, Institute of Agriculture 
and Natural Resources, G1448, January 2002. Accessed online at 
http://www.ianrpubs.unl.edu/epublic/live/g1448/build/g1448.pdf.
    4. International Bottled Water Association, 2005, IBWA Model 
Code, Version March 2005. Accessed online at http://www.bottledwater.org/public/pdf/IBWA05ModelCode_Mar2.pdf.
    5. Economic Analysis for the Final Groundwater Rule. Office of 
Water (4606-M) EPA 815-R-06-014 October 2006. Section 6.2.2 
Laboratory Fees. Accessed online at: http://www.epa.gov/safewater/disinfection/gwr/pdfs/support_gwr_economicanalysis.pdf.
    6. Economic Analysis for the Final Groundwater Rule. Office of 
Water (4606-M) EPA 815-R-06-014 October 2006. Section 4.2.7 
Triggered Monitoring Baseline. p. 4-21 and 4-22. Accessed online at 
http://www.epa.gov/safewater/disinfection/gwr/pdfs/support_gwr_economicanalysis.pdf.
    7. Economic Analysis for the Final Groundwater Rule. Office of 
Water (4606-M) EPA 815-R-06-014 October 2006. Section 6.4.4 Sanitary 
Survey Corrective Actions. p. 6-33. Accessed online at http://www.epa.gov/safewater/disinfection/gwr/pdfs/support_gwr_economicanalysis.pdf.
    8. Technology and Cost Document for the Final Ground Water Rule. 
Office of Water (4606-M) EPA 815-R-06-015 October 2006. Section 
5.3.1 Significant Deficiency Corrective Actions. p. 5-11. Accessed 
online at http://www.epa.gov/safewater/disinfection/gwr/pdfs/support_gwr_cost-technologies.pdf.
    9. Eastern Research Group, Inc., ``Model for Estimating the 
Impacts of Regulatory Costs on the Survival of Small Businesses and 
its Application to Four FDA-Regulated Industries,'' Contract No. 
223-01-2461, June 7, 2002.

List of Subjects

21 CFR Part 129

    Beverages, Bottled water, Food packaging, Reporting and 
recordkeeping requirements.

21 CFR Part 165

    Beverages, Bottled water, Food grades and standards, Incorporation 
by reference.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
129 and 165 are amended as follows:

PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER

0
1. The authority citation for 21 CFR part 129 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 348, 371, 374; 42 U.S.C. 264.

0
2. Section 129.35 is amended by revising paragraphs (a)(3)(i) and 
(a)(4)(iv) to read as follows:


Sec.  129.35  Sanitary facilities.

* * * * *
    (a) * * *
    (3) * * *
    (i) Samples of source water from each source in use by the plant 
are to be taken and analyzed by the plant as often as necessary, but at 
a minimum frequency of once each year for chemical contaminants and 
once every 4 years for radiological contaminants. Additionally, source 
water obtained from other than a public water system is to be sampled 
and analyzed for total coliform at least once each week. If any 
coliform organisms are detected, follow-up testing must be conducted to 
determine whether any of the coliform organisms are Escherichia coli. 
This sampling is in addition to any performed by government agencies 
having jurisdiction. Source water found to contain E. coli is not 
considered water of a safe, sanitary quality as required for use in 
bottled water by paragraph (a)(1) of this section. Before a bottler can 
use source water from a source that has tested positive for E. coli, 
the bottler must take appropriate measures to rectify or otherwise 
eliminate the cause of E. coli contamination of that source in a manner 
sufficient to prevent its reoccurrence. 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. 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 are to be maintained 
on file at the plant.
* * * * *
    (4) * * *
    (iv) The finished bottled water must comply with bottled water 
quality standards (Sec.  165.110(b) of this chapter) and section 
402(a)(1) and (a)(3) of the

[[Page 25665]]

Federal Food, Drug, and Cosmetic Act dealing with adulterated foods.
* * * * *

0
3. Section 129.80 is amended by revising paragraph (g)(1) to read as 
follows:


Sec.  129.80  Processes and controls.

* * * * *
    (g) * * *
    (1) For bacteriological purposes, take and analyze at least once a 
week for total coliform a representative sample from a batch or segment 
of a continuous production run for each type of bottled drinking water 
produced during a day's production. The representative sample shall 
consist of primary containers of product or unit packages of product. 
If any coliform organisms are detected, follow-up testing must be 
conducted to determine whether any of the coliform organisms are E. 
coli.
* * * * *

PART 165--BEVERAGES

0
4. The authority citation for 21 CFR part 165 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.

0
5. Section 165.110 is amended by revising paragraphs (b)(2), (b)(3) 
introductory text, (c)(1), and (d) to read as follows:


Sec.  165.110  Bottled water.

* * * * *
    (b) * * *
    (2) Microbiological quality. (i) Bottled water shall, when a sample 
consisting of analytical units of equal volume is examined by the 
methods described in paragraph (b)(2)(ii) of this section, meet the 
following standards of microbiological quality:
    (A) Total coliform--(1) Multiple-tube fermentation (MTF) method. 
Not more than one of the analytical units in the sample shall have a 
most probable number (MPN) of 2.2 or more coliform organisms per 100 
milliliters and no analytical unit shall have an MPN of 9.2 or more 
coliform organisms per 100 milliliters; or
    (2) Membrane filter (MF) method. Not more than one of the 
analytical units in the sample shall have 4.0 or more coliform 
organisms per 100 milliliters and the arithmetic mean of the coliform 
density of the sample shall not exceed one coliform organism per 100 
milliliters.
    (B) E. coli. If E. coli is present, then the bottled water will be 
deemed adulterated under paragraph (d) of this section.
    (ii) Analyses conducted to determine compliance with paragraphs 
(b)(2)(i)(A) and (b)(2)(i)(B) of this section and Sec.  129.35(a)(3)(i) 
of this chapter shall be made in accordance with the multiple-tube 
fermentation (MTF) or the membrane filter (MF) methods described in the 
applicable sections of ``Standard Methods for the Examination of Water 
and Wastewater,'' 21st Ed. (2005), American Public Health Association. 
The Director of the Federal Register approves this incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may 
obtain a copy from the American Public Health Association, 800 I St. 
NW., Washington, DC 20001, 202-777-2742 (APHA). You may inspect a copy 
at the Center for Food Safety and Applied Nutrition's Library, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2163, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (3) Physical quality. Bottled water shall, when a composite of 
analytical units of equal volume from a sample is examined by the 
method described in applicable sections of ``Standard Methods for the 
Examination of Water and Wastewater,'' 15th Ed. (1980), American Public 
Health Association, which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51 (copies may be obtained from the 
American Public Health Association, 800 I St. NW., Washington, DC 
20001, 202-777-2742 (APHA), or a copy may be examined at the National 
Archives and Records Administration (NARA), or at the Center for Food 
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 301-436-2163, for information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html), meet the following standards of 
physical quality:
* * * * *
    (c) Label statements. * * *
    (1) ``Contains Excessive Bacteria'' if the bottled water fails to 
meet the requirements of paragraph (b)(2)(i)(A) of this section.
* * * * *
    (d) Adulteration. Bottled water containing a substance at a level 
considered injurious to health under section 402(a)(1) of the Federal 
Food, Drug, and Cosmetic Act (the act), or that consists in whole or in 
part of any filthy, putrid, or decomposed substance, or that is 
otherwise unfit for food under section 402(a)(3) of the act is deemed 
to be adulterated, regardless of whether or not the water bears a label 
statement of substandard quality prescribed by paragraph (c) of this 
section. If E. coli is present in bottled water, then the bottled water 
will be deemed adulterated under section 402(a)(3) of the act.

    Dated: May 21, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12494 Filed 5-26-09; 8:45 am]
BILLING CODE 4160-01-S