Beverages; Bottled Water, 53775-53793 [E8-21619]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 181 (Wednesday, September 17, 2008)]
[Proposed Rules]
[Pages 53775-53793]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21619]


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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its bottled water regulations to require that source water, which is 
currently subject to weekly microbiological testing, be tested 
specifically for total coliform as is done for finished bottled water 
products. Further, FDA is proposing that if any coliform organisms are 
detected in source water or finished bottled water products, bottled 
water manufacturers would be required to test for the bacterium 
Escherichia coli (E. coli), an indicator of fecal contamination. FDA 
also is proposing to amend the adulteration provision of the bottled 
water standard to reflect the possibility

[[Page 53776]]

of adulteration caused by the presence of filth. Bottled water 
containing E. coli would be considered adulterated, and source water 
containing E. coli would not be considered to be of a safe, sanitary 
quality and would be prohibited from use in the production of bottled 
water. In addition, this rule would require bottlers to rectify or 
eliminate the source of E. coli contamination in source water and keep 
records of such actions. Existing regulatory provisions would require 
bottled water manufacturers to keep records of new testing required by 
this rule. FDA tentatively concludes that this proposed rule, if 
finalized, 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: Submit written or electronic comments on the proposed rule by 
November 17, 2008. Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 by October 17, 2008 (see the 
``Paperwork Reduction Act of 1995'' section of this document). See 
section XI of the SUPPLEMENTARY INFORMATION section of this document 
for the proposed effective date of the final rule based on the proposed 
rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0446, by any of the following methods, except that comments on 
information collection issues under the Paperwork Reduction Act of 1995 
must be submitted to the Office of Regulatory Affairs, Office of 
Management and Budget (OMB) (see the ``Paperwork Reduction Act of 
1995'' section of this document).
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously in the ADDRESSES portion of 
this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All comments received may be 
posted without change to https://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading in the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

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:

Table of Contents

I. Background
II. EPA's Ground Water Rule
    A. Sanitary Surveys
    B. Triggered Source Water Monitoring
    C. Assessment Source Water Monitoring
    D. Corrective Action Treatment Technique Requirements
    E. Compliance Monitoring for 4-Log Viral Disinfection
    F. Public Notification Requirements
    G. Reporting and Recordkeeping Requirements
    H. Effective Date of the GWR
III. FDA Standards
    A. Standard of Quality
    B. Microbiological Quality Standard
    C. Current Good Manufacturing Practices
IV. FDA Proposal
    A. Proposed Changes
    B. Microbiological Quality Standard
    C. CGMP Regulations for Bottled Water
    D. Analytical Methods for E. coli Testing
    E. Monitoring and Recordkeeping Provisions of CGMP Regulations 
for Bottled Water
V. Legal Authority
VI. Environmental Impact Analysis
VII. Executive Order 12866 and Regulatory Flexibility Act
    A. Preliminary Economic Impact Analysis
    B. Small Entity Analysis
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Comments
XI. Effective Date of the Related Final Rule
XII. References

I. Background

    FDA has established specific regulations for bottled water in Title 
21 of the Code of Federal Regulations, including standard of identity 
regulations in part 165 (21 CFR part 165) (Sec.  165.110(a)) that 
define different types of bottled water and standard of quality 
regulations (Sec.  165.110(b)) that establish allowable levels for 
contaminants in bottled water. FDA also has established current good 
manufacturing practice (CGMP) regulations for the processing and 
bottling of bottled water (part 129 (21 CFR part 129)).
    Unlike bottled water, which is regulated as a food by FDA, public 
drinking water in the United States is regulated by the EPA. The Safe 
Drinking Water Act (SDWA) (42 U.S.C. 300f et seq.), as amended in 1996, 
requires EPA to publish a National Primary Drinking Water Regulation 
(NPDWR) that specifies either a maximum contaminant level (MCL) or a 
treatment technique requirement for contaminants that may ``have an 
adverse effect on the health of persons,'' are ``known to occur or 
[have] a substantial likelihood [of occurring] in public water systems 
with a frequency and at levels of public health concern,'' and for 
which ``regulation * * * presents a meaningful opportunity for health 
risk reduction for persons served by public water systems'' (SDWA 
section 1412(b)(1)(A) (42 U.S.C. 300g-1(b)(1)(A))). Under section 
410(b)(1) of the Federal Food, Drug, and Cosmetic Act (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 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 public water systems 
(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. EPA's Ground Water Rule

    In the Federal Register of November 8, 2006 (71 FR 65574), EPA 
published a new NPDWR, the Ground Water Rule (GWR), to provide for 
increased protection against fecal microbial pathogens in PWSs that use 
ground water sources (also referred to as ground water systems (GWSs)). 
In the GWR,

[[Page 53777]]

EPA established treatment techniques intended to identify and target 
GWSs that are susceptible to fecal contamination and require such GWSs 
to monitor and, when necessary, take corrective action to prevent or 
remove such contamination. Corrective action can include correcting all 
significant deficiencies, providing an alternative source of water, 
eliminating the source of contamination, or providing treatment that 
reliably achieves at least 4-log (99.00 percent) treatment of viruses 
(71 FR 65574 at 65602). The GWR also contains compliance monitoring 
requirements to ensure that treatment effectiveness is maintained when 
treatment is used as a corrective action, as well as notification 
requirements when GWS deficiencies occur.
    EPA issued the GWR to protect public health because some GWSs may 
be at risk of supplying water that contains harmful microbial pathogens 
from fecal contamination. Ingestion of contaminated water can result in 
gastrointestinal illness, typically characterized by diarrhea, 
vomiting, nausea, and abdominal discomfort. Most gastrointestinal 
illnesses are mild and self-limiting, but these diseases can be more 
serious and potentially fatal in sensitive individuals, such as the 
elderly, young children, and persons with compromised immune systems. 
More serious illnesses such as meningitis, hepatitis, Legionnaires' 
disease, and myocarditis can also result from exposure to waterborne 
microbial contaminants (71 FR 65574 at 65576 and 65580).
    The potential for illness to arise from fecal pathogen-contaminated 
ground water is demonstrated by data from the Centers for Disease 
Control and Prevention (CDC) indicating that GWSs were associated with 
68 waterborne disease outbreaks and 10,926 illnesses between 1991 and 
2000 (71 FR 65574 at 65576). These 68 outbreaks accounted for 51 
percent of waterborne disease outbreaks in the United States from 1991 
to 2000. The CDC identified source water contamination and inadequate 
treatment (or treatment failures) as the likely cause of the outbreaks 
(71 FR 65574 at 65576).
    Ground water may also be contaminated with fecal indicators, such 
as E. coli, enterococci, or coliphage. Such fecal indicators typically 
are not harmful themselves, but their presence demonstrates that there 
is a pathway for pathogenic enteric viruses (e.g., echovirus, Coxsackie 
viruses, hepatitis A and E viruses, rotavirus, and noroviruses) and 
pathogenic enteric bacteria (e.g., Salmonella, Shigella, Vibrio 
cholerae, and pathogenic strains of E. coli) to enter ground water 
sources (71 FR 65574 at 65576).
    In the GWR, EPA reviewed studies that showed the presence of fecal 
indicators or viral pathogens in dozens of public ground water wells 
(71 FR 65574 at 65576 and 65583). For example, analysis by EPA of a 
subset of 15 studies found that approximately 26 percent of the wells 
included in the studies sometimes have fecal contamination, as 
indicated by E. coli, and approximately 27 percent of the wells 
sometimes have viral contamination, as indicated by enterovirus (71 FR 
65574 at 65583 through 65584).
    In the GWR, EPA identified different pathways by which fecal 
contamination may reach ground water sources. One pathway involves 
travel through the subsurface to the intake zone of a ground water 
source, with movement being more likely through materials such as 
karst, gravel, or fractured bedrock. Potential sources of subsurface 
fecal contamination include improperly stored or managed manure, runoff 
from land-applied manure, leaking sewer lines, or failed septic systems 
(71 FR 65574 at 65581). A second pathway is for fecal contamination 
from the surface to enter a well along the casing or through cracks in 
the sanitary seal if the well is not properly constructed, protected, 
or maintained (71 FR 65574 at 65581).
    EPA has found that existing regulatory provisions for GWSs do not 
adequately address the potential for fecal contamination of ground 
water sources. Prior to the GWR, there were no Federal regulations 
requiring monitoring or disinfection of ground water sources or 
requiring corrective action when fecal contamination or a risk of fecal 
contamination is found (71 FR 65574 at 65576).
    Based on data from ground water-related outbreaks, the occurrence 
of fecal indicators in ground water sources, and the lack of 
regulations addressing fecal contamination of ground water sources, EPA 
concluded that the GWR is necessary to protect public health from 
potential exposure to bacterial and viral pathogens in fecally 
contaminated or at-risk ground water sources (71 FR 65574 at 65576).
    EPA uses what that agency referred to as a ``risk-targeted'' 
approach in the GWR to identify public drinking-water GWSs susceptible 
to fecal contamination and to target those systems that must take 
corrective action to protect public health. EPA requirements include 
the following (71 FR 65574 at 65577):

A. Sanitary Surveys

    Under the GWR, EPA, or States with primacy\1\ for enforcing EPA's 
regulations, are required to perform regular comprehensive sanitary 
surveys\2\ of up to eight components of GWSs: (1) Source; (2) 
treatment; (3) distribution system; (4) finished water storage; (5) 
pumps, pump facilities, and controls; (6) monitoring, reporting, and 
data verification; (7) system management and operation; and (8) 
operator compliance with State requirements (71 FR 65574 at 65577 and 
65586 through 65587). These requirements are codified at 40 CFR 
141.401. The purpose of the surveys is to identify ``significant 
deficiencies'' that are causing or could cause the introduction of 
contamination into water delivered to consumers. Examples of 
significant deficiencies related to water sources for GWSs include the 
following: (1) A well near a source of fecal contamination, such as a 
failing septic system or a leaking sewer line; (2) a well in a flood 
zone; (3) an improperly constructed well (e.g., improper surface or 
subsurface seal); and (4) spring boxes that are poorly constructed and/
or subject to flooding. Examples of significant deficiencies related to 
treatment and finished water storage include inadequate treatment 
process monitoring and inadequate internal cleaning and maintenance of 
storage tanks (71 FR 65574 at 65587).
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    \1\ The term ``primacy'' refers to EPA granting a State primary 
enforcement responsibility for NPDWRs after determining that the 
State had adopted regulations that are no less stringent than EPA's. 
See 71 FR 65574 at 65579.
    \2\ For purposes of the EPA GWR, a ``sanitary survey, as 
conducted by the State, includes but is not limited to, an onsite 
review of the water source(s) (identifying sources of contamination 
by using results of source water assessments or other relevant 
information where available), facilities, equipment, operation, 
maintenance, and monitoring compliance of a public water system to 
evaluate the adequacy of the system, its sources and operations and 
the distribution of safe drinking water.'' See 40 CFR 141.401(b).
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    States with primacy must conduct initial sanitary surveys of GWSs 
by December 31, 2012, or December 31, 2014, depending on the type of 
GWS and whether certain performance criteria are met,\3\ and repeat 
those surveys every 3 or 5 years, depending on the type of GWS and 
performance history. GWSs must correct significant

[[Page 53778]]

deficiencies identified in the surveys within 120 days of State 
notification (or be in compliance with a State-approved corrective 
action plan and schedule). Systems that fail to make corrections will 
be in violation of treatment technique requirements. GWSs must also 
notify customers of uncorrected significant deficiencies and timelines 
for correction (71 FR 65574 at 65586 through 65587).
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    \3\ States are required to complete the initial sanitary survey 
cycle for community water systems (CWSs) by December 31, 2012 
(except those CWSs that meet certain performance criteria), or by 
December 31, 2014, in the case of all noncommunity water systems 
(NCWSs) and CWSs that meet certain performance criteria (71 FR 65574 
at 65586).
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B. Triggered Source Water Monitoring

    Triggered source water monitoring is followup monitoring for fecal 
indicators in source water that occurs when total coliforms are found 
in distribution systems. The GWR requires GWSs to conduct triggered 
source water monitoring within 24 hours of receiving notification that 
a routine monitoring sample collected under the Total Coliform Rule 
(TCR)\4\ is total coliform-positive. Triggered source water monitoring 
consists of testing at least one ground water sample from each ground 
water source in use at the time the TCR-positive sample was collected 
for a fecal indicator. If a triggered sample is fecal-indicator 
positive, the GWS must notify the State and the public. Unless directed 
by the State to take immediate corrective action, the GWS then must 
collect five additional source water samples from the site that tested 
positive within 24 hours for testing for the same fecal indicator. If 
any of the five additional samples tests positive for the fecal 
indicator, the GWS must notify the State and the public and comply with 
treatment technique requirements (71 FR 65574 at 65577 and 65590 
through 65594). The GWR requires States to designate one of three EPA-
approved fecal indicators for each GWS: E. coli, enterococci, or 
coliphage. EPA also has approved seven methods for E. coli testing, 
three methods for enterococci, and two methods for coliphage, and 
specified a minimum 100-milliliter (mL) sample volume (71 FR 65574 at 
65597).
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    \4\ In the Total Coliform Rule (54 FR 27544, June 29, 1989), EPA 
set both health goals (maximum contaminant level goals or MCLGs) and 
legal limits (MCLs) for the presence of total coliform in drinking 
water. The rule also details the type and frequency of testing that 
water systems must undertake. The rule applies to all PWSs.
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    The GWR provides exemptions from triggered source water monitoring 
for systems providing at least 4-log treatment of viruses or when 
samples are either invalidated or determined to be related to 
distribution system contamination. The GWR also establishes criteria 
for representative source water monitoring for GWSs with multiple 
sources and triggered source monitoring requirements for GWSs that 
purchase or sell finished drinking water (71 FR 65574 at 65592). The 
requirements for triggered source water monitoring are codified at 40 
CFR 141.402 of EPA's regulations.

C. Assessment Source Water Monitoring

    The GWR provides States with the option of requiring GWSs at higher 
risk of fecal contamination to conduct more stringent assessment source 
water monitoring. Although the exact monitoring scheme is left to the 
State, EPA recommends collecting and analyzing a minimum of 12 ground 
water samples representing each month the system is providing water. 
The fecal indicators and approved methods for assessment monitoring are 
the same as for triggered source water monitoring (71 FR 65574 at 65594 
through 65597). (See 40 CFR 141.402(b) of EPA's regulations.)

D. Corrective Action Treatment Technique Requirements

    Under the GWR, GWSs are subject to treatment technique requirements 
to address significant deficiencies identified during sanitary surveys 
or during monitoring (i.e., fecal contamination in ground water). When 
a GWS receives notice of a significant deficiency or a fecal indicator-
positive sample, the GWS must consult with the State to develop a 
corrective action schedule within 30 days and complete the State-
approved corrective actions within 120 days (or within the timeline 
approved by the State) (71 FR 65574 at 65601 through 65602).
    Corrective action options allowed under the GWR include: (1) 
Correct significant deficiencies (e.g., repair well pads and sanitary 
seals), (2) use an alternate water source, (3) eliminate the source of 
contamination (e.g., provide or fix fencing or housing of wellhead, 
redirect drainage and runoff), and (4) provide treatment that reliably 
achieves at least 4-log treatment of viruses (using inactivation, 
removal, or a State-approved combination of 4-log virus inactivation 
and removal) (71 FR 65574 at 65602). (See 40 CFR 141.403(a) of EPA's 
regulations.)

E. Compliance Monitoring for 4-Log Viral Disinfection

    The GWR establishes compliance monitoring requirements for GWSs 
that use at least 4-log disinfection treatment of viruses as a 
corrective action or as an alternative to triggered source water 
monitoring. GWSs using chemical disinfection must maintain a State-
approved residual disinfectant concentration every day the GWS provides 
water from the source, with exact monitoring requirements depending on 
system size. If disinfectant concentrations fall below levels required 
for 4-log viral inactivation for more than 4 hours, the systems will 
incur a treatment technique violation (71 FR 65574 at 65602). Likewise, 
systems that use membrane technologies or alternative treatment 
technologies (such as ultraviolet radiation) for disinfection must meet 
State requirements for maintaining, operating, and monitoring these 
technologies. Systems that fail to meet State operation or integrity 
requirements must correct the problem within 4 hours or be in violation 
of treatment technique requirements (71 FR 65574 at 65602 through 
65603). (See 40 CFR 141.403(b) and 141.404 of EPA's regulations.)

F. Public Notification Requirements

    The GWR requires GWSs to notify the public if monitoring samples 
are positive for a fecal indicator, if the GWSs fail to take required 
corrective actions or follow a State-approved corrective action plan 
and schedule, or if they fail to maintain 4-log treatment of viruses 
when they have elected to provide 4-log treatment in lieu of triggered 
source water monitoring. In addition, GWSs must notify the public if 
they fail to conduct source water monitoring or if they fail to conduct 
monitoring to demonstrate compliance with the 4-log disinfection 
treatment requirement (71 FR 65574 at 65607). (See also 40 CFR 
141.402(g), 141.403(d), and 141.404(d) of EPA's regulations.) Depending 
on how soon they take corrective actions, GWSs may also be required to 
provide annual notice of uncorrected significant deficiencies or fecal-
indicator positive source water samples in annual Consumer Confidence 
Reports or in annual public notices (71 FR 65574 at 65608). (See 40 CFR 
141.403(a)(7) of EPA's regulations.)

G. Reporting and Recordkeeping Requirements

    The GWR also introduces new reporting and recordkeeping 
requirements for GWSs. New reporting requirements for GWSs include: 
Reporting completion of corrective actions, reporting failure to meet 
disinfection compliance requirements for more than 4 hours, and 
submitting documentation of findings that total coliform positive 
samples result from distribution system conditions rather than from 
source water contamination (71 FR 65574 at 65610). New recordkeeping 
requirements for GWSs include maintaining documentation of

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the following items: Corrective actions, GWR-related public notices, 
determinations that total coliform positive samples result from 
distribution system conditions, disinfection compliance monitoring 
records, and notifications of TCR-positive samples by systems that sell 
water to other systems (71 FR 65574 at 65610). The GWR also establishes 
new reporting, recordkeeping, and primacy requirements that States must 
meet to assume and maintain enforcement primacy for their PWSs (71 FR 
65574 at 65610). (See 40 CFR 141.405 of EPA's regulations.)

H. Effective Date of the GWR

    The compliance date for triggered source water monitoring, 
compliance monitoring, and treatment technique requirements for GWSs 
under the GWR is December 1, 2009 (71 FR 65574 at 65577 through 65578). 
States with primacy for enforcing EPA's regulations have until December 
31, 2012, to complete the initial sanitary survey cycle for community 
water systems (CWSs), except those that meet certain performance 
criteria, and until December 31, 2014, to complete the initial sanitary 
survey cycle for all noncommunity water systems (NCWSs) and CWSs that 
meet certain performance criteria (71 FR 65574 at 65586 through 65587).

III. FDA Standards

    Under section 410(b)(1) of the act, not later than 180 days before 
the effective date (EPA compliance date) of an NPDWR issued by EPA for 
a contaminant under section 1412 of the 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. 
Section 410(b)(3) of the act requires the standard of quality for a 
contaminant in bottled water to be no less stringent than EPA's MCL and 
no less protective of the public health than EPA's treatment technique 
requirements for the same contaminant. The effective date for any such 
standard of quality regulation is to be the same as the effective date 
of the NPDWR. If FDA fails to take any action within the prescribed 
time period in response to the NPDWR issued by EPA, then section 
410(b)(4)(A) of the act provides that EPA's NPDWR will apply to bottled 
water. In addition, section 410(b)(2) of the act provides that a 
standard of quality regulation issued by FDA shall include monitoring 
requirements that the agency determines to be appropriate for bottled 
water.

A. Standard of Quality

    Under section 401 of the act (21 U.S.C. 341), the agency may issue 
a regulation establishing a standard of quality for a food under its 
common or usual name, when in the judgment of the Secretary of Health 
and Human Services ``such action will promote honesty and fair dealing 
in the interest of consumers.'' On November 26, 1973 (38 FR 32558), FDA 
established a standard of quality for bottled water that now is set 
forth in Sec.  165.110(b).
    Manufacturers of bottled water are responsible for ensuring, 
through appropriate manufacturing techniques and sufficient quality 
control procedures, that all bottled water products introduced or 
delivered for introduction into interstate commerce comply with the 
standard of quality (Sec.  165.110(b)). Bottled water that is of a 
quality below the prescribed standard is required by Sec.  165.110(c) 
to be labeled with a statement of substandard quality or it is deemed 
misbranded under section 403(h)(1) of the act (21 U.S.C. 343(h)(1)). 
FDA notes that a statement of substandard quality only prevents bottled 
water that exceeds an allowable level for a contaminant from being 
misbranded with regard to that contaminant; it does not prevent the 
water from being adulterated or otherwise misbranded. This is reflected 
in FDA's general food standards which state in relevant part that 
``[n]o provision of any regulation prescribing a * * * standard of 
quality * * * shall be construed as in any way affecting the concurrent 
applicability of the general provisions of the act and the regulations 
thereunder relating to adulteration and misbranding'' (21 CFR 
130.3(c)). In addition, for purposes of emphasis, the regulations 
currently provide that any bottled water containing a substance at a 
level that causes the food to be adulterated under section 402(a)(1) of 
the act (21 U.S.C. 342(a)(1)) is subject to regulatory action, even if 
the bottled water bears a label statement of substandard quality (Sec.  
165.110(d)).
    FDA has in the past most often fulfilled its obligation under 
section 410 of the act to respond to EPA's issuance of NPDWRs by 
amending the standard of quality regulations for bottled water to 
maintain compatibility with EPA's drinking water regulations (e.g., 
most recently by lowering the allowable level for arsenic (70 FR 33694, 
June 9, 2005)). In these rules, FDA has found that the relevant EPA 
standards for particular contaminants in drinking water were generally 
appropriate as allowable levels for contaminants in the standard of 
quality for bottled water when bottled water may be expected to contain 
the same contaminants. Further, because bottled water is increasingly 
used in some households as a replacement for tap water, consumption 
patterns considered by EPA for tap water can be used as an estimate for 
the maximum expected consumption of bottled water by some individuals.

B. Microbiological Quality Standard

    Under the current standard of quality for bottled water, as set 
forth in Sec.  165.110(b)(2), bottled water must meet one of the 
following standards of microbiological quality: (1) By the 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 mL and no analytical unit shall have an 
MPN of 9.2 or more coliform organisms per 100 mL; or (2) by the 
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 mL and 
the arithmetic mean of the coliform density of the sample shall not 
exceed one coliform organism per 100 mL.

C. Current Good Manufacturing Practices

    FDA has established CGMP regulations for bottled water in part 129. 
The CGMPs address source approval, plant construction and design, 
sanitary facilities and operations, equipment, and production and 
process controls. Under Sec.  129.35(a)(3)(i), source water obtained 
from other than a PWS is to be sampled and analyzed for microbiological 
contaminants at least once each week. To ensure that a plant's 
production complies with applicable standards, including the standard 
of quality for bottled water products in Sec.  165.110(b), Sec.  
129.80(g)(1) of the CGMP regulations requires bacteriological analysis 
by the plant, at least once a week, of a representative sample from a 
batch or segment of a continuous production run for each type of 
bottled water produced during a day's production. In addition, the 
CGMPs require maintenance of testing records for 2 years (Sec.  
129.80(g)(3) and (h)).

IV. FDA Proposal

A. Proposed Changes

    Ground water is the source water for approximately 70 to 75 percent 
of U.S. bottled water products (Ref. 1). As a result, the potential for 
fecal

[[Page 53780]]

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, as 
is currently required for finished bottled water products. Further, FDA 
is proposing that if any coliform organisms are detected in source 
water or in finished bottled water products, bottled water 
manufacturers would be required to test for E. coli, an indicator of 
fecal contamination. FDA tentatively concludes that the proposed 
requirements, as discussed in the following paragraphs, would help 
ensure that bottled water is subject to requirements no less protective 
of the public health than the treatment techniques adopted by EPA in 
the GWR for public drinking water.
1. Finished Bottled Water Testing
    The bottled water CGMP regulations contain compliance procedures 
(Sec.  129.80(g)) that require that bottlers test a representative 
sample of finished bottled water at least once a week for 
bacteriological purposes. The bottled water standard of quality 
regulations establish allowable levels for total coliform in finished 
bottled water products (Sec.  165.110(b)(2)). FDA is proposing that if 
the total coliform test in finished bottled water products is positive 
(i.e., even if below the allowable levels for total coliform), bottlers 
would be required to test for E. coli. FDA is proposing to use the 
presence of any coliform as a trigger for E. coli testing, rather than 
the allowable levels in Sec.  165.110(b)(2), because the presence of 
any amount of total coliform indicates the potential for fecal 
contamination. This is consistent with EPA's approach to triggered 
testing in the GWR. As discussed further in the legal authority section 
of this document, if bottled water products test positive for E. coli, 
the products would be deemed adulterated under section 402(a)(3) of the 
act.
2. Source Water Testing
    The bottled water CGMPs (Sec.  129.35(a)(3)) require that bottlers 
conduct microbiological tests of source water obtained from other than 
a PWS at least once a week, but do not specify the type of testing 
(i.e., for what organism) or an allowable level of microbiological 
contamination. FDA is proposing that bottlers that obtain their water 
from other than a PWS test their source water at least once a week for 
total coliform and, if any coliform organisms are detected, that they 
conduct followup testing for E. coli. (PWSs are covered by EPA's GWR 
and bottlers that obtain their water from a PWS are exempt from source 
water testing (Sec.  129.35(a)(3)).) If the followup test is positive 
for E. coli, FDA would consider the source water to be not of a safe, 
sanitary quality, and therefore its use in bottled water would be 
prohibited. FDA is proposing to specify that the microbiological 
testing must be for total coliform to make testing requirements for 
source and finished bottled water uniform and to remove any uncertainty 
in the CGMPs about the appropriate microbiological tests for bottlers 
to conduct. FDA believes that most bottlers currently use total 
coliform testing to conduct source water tests, as is required for 
finished product tests in the quality standard. In addition, triggered 
testing requirements for fecal indicators such as E. coli in the EPA 
GWR are also based on initial total coliform results.
    FDA is proposing to require followup source water testing for E. 
coli to increase public health protection by determining whether source 
water is contaminated and prohibiting use of such water. These 
requirements would help ensure that bottled water is subject to 
requirements no less protective of the public health than those 
applicable to drinking water under the GWR. As noted previously, 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 public health. Based on its concerns, EPA is requiring 
testing for a fecal indicator (E. coli, enterococci, or coliphage) in 
source water in response to a total coliform positive finding in the 
distribution system. Similarly, FDA believes that it is appropriate to 
require E. coli testing in response to a total coliform positive 
finding from weekly source water sampling.
    FDA is proposing that source water that tests positive for E. coli 
would not be considered to be of a safe, sanitary quality for bottling, 
as is required for use in bottled water by Sec.  129.35(a)(1). 
Therefore, bottlers could not use this water for production of bottled 
water until they have rectified or otherwise eliminated the source 
water contamination, and the source water has been retested 
sufficiently to be considered negative for E. coli. FDA is further 
proposing that a source would be considered negative for E. coli after 
five samples collected from the source over a 24-hour period are tested 
and found to be E. coli negative. FDA solicits comment on alternative 
criteria for allowing use of source water following an E. coli positive 
test.
    This proposal does not include specific requirements regarding how 
to rectify or otherwise eliminate E. coli contamination of source 
water. Bottlers may wish to consult with States or with EPA, or review 
EPA guidance (https://www.epa.gov/safewater/disinfection/gwr/
compliancehelp.html), for advice on how to eliminate sources of 
contamination.
    FDA also did not include a requirement for a sanitary survey in 
this proposal. First, FDA does not have a primacy program arrangement 
with the States for conducting sanitary surveys of ground water sources 
used by bottled water manufacturers, unlike EPA, which has a primacy 
program with the States under the SDWA for sanitary surveys of ground 
water sources used by PWSs. Second, the CGMPs 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.'' In addition, this proposal 
requires both weekly source water testing and finished bottled water 
testing for total coliform, with E. coli testing in case of a total 
coliform positive. In contrast, EPA's GWR, which does require a 
sanitary survey, does not require source water testing for ground water 
sources unless total coliform is detected in the distribution system. 
FDA tentatively concludes 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 
CGMPs for source inspection and approval would help ensure that bottled 
water is subject to requirements no less protective of the public 
health than those applicable to drinking water under the GWR.
    The bottled water CGMPs currently require that bottlers maintain at 
the plant records regarding any sampling and analysis of source water 
(Sec.  129.35(a)(3)(i)), and that such records be maintained at the 
plant for not less than 2 years (Sec.  129.80(h)). This requirement 
would include any records

[[Page 53781]]

related to testing and retesting for E. coli, in addition to at least 
weekly testing for total coliform.
    FDA also is proposing in Sec.  129.35(a)(3)(i) that bottlers 
maintain records of corrective measures taken to rectify or otherwise 
eliminate the cause of E. coli contamination in source water. Such 
records would need to be maintained at the plant for not less than 2 
years under Sec.  129.80(h). Examples of appropriate records could 
include receipts demonstrating that expenses were incurred to have 
equipment repaired or a memorandum outlining how a source of 
contamination was identified and removed.
3. Fecal Indicator
    Under the GWR, EPA is allowing States with primacy the discretion 
to designate E. coli, enterococci, or coliphage as fecal indicators 
following a total coliform positive test, noting that the most 
appropriate indicator, in the context of a PWS, may vary from State to 
State or site to site (71 FR 65574 at 65597). EPA found that testing 
for any one of these microorganisms as a single fecal indicator 
provides a cost-effective means for identifying fecally contaminated 
wells and protecting public health (71 FR 65574 at 65597). In this 
proposed rule, FDA is proposing to require a single fecal indicator, E. 
coli, rather than allowing bottlers to choose from among the three 
fecal indicators identified in the GWR. We believe that requiring that 
all bottlers test for the same specific fecal indicator will allow FDA 
to most effectively administer and enforce its bottled water 
regulations. We have chosen E. coli as the appropriate fecal indicator 
because approved analytical methods for E. coli are commercially 
available, simple, reliable, and inexpensive (see 71 FR 65574 at 
65597). We note that EPA believes that E. coli will be the fecal 
indicator most likely designated by States with primacy for 
implementation of the GWR, because E. coli is already used for followup 
testing under the TCR, and PWSs are familiar with its use and 
interpretation (71 FR 65574 at 65583).

B. Microbiological Quality Standard

    Section 129.80(g) of the bottled water CGMPs contains compliance 
procedures for the standard of quality in Sec.  165.110(b) and requires 
that bottlers test a representative sample of each type of bottled 
drinking water produced during a day's production at least once a week 
for bacteriological purposes. FDA is proposing that E. coli shall not 
be present in bottled water under a new microbiological quality 
standard in Sec.  165.110(b)(2)(i)(B). Further, under proposed Sec.  
129.80(g)(1), if any coliform organisms are detected in a sample of 
bottled water, bottled water manufacturers would be required to conduct 
followup testing for the fecal indicator E. coli. If E. coli is 
detected, then the batch or daily production run of bottled water 
represented by the sample would be deemed adulterated under Sec.  
165.110(d) of the bottled water standard, as revised.
    This followup testing would help ensure the absence of fecal 
contamination in finished bottled water products and help ensure that 
bottled water is subject to requirements no less protective of the 
public health than those applicable to drinking water.
    The requirement for bottled water to meet the allowable level for 
total coliform in the standard of quality unless the label bears a 
statement of substandard quality under Sec.  165.110(c) for bottled 
water would remain. The labeling provision would be relevant if bottled 
water exceeds the total coliform standard but tests negative for E. 
coli. In contrast, because any E. coli in bottled water causes the 
water to be adulterated, the substandard labeling provision is not 
relevant for E. coli.
    FDA is also proposing to revise the adulteration provision in Sec.  
165.110(d) to clarify the potential application of section 402(a)(3) of 
the act to bottled water, in addition to section 402(a)(1) of the act. 
Current Sec.  165.110(d) provides that bottled water containing a 
substance injurious to health under section 402(a)(1) of the act is 
deemed to be adulterated, regardless of whether the bottle bears a 
label statement of substandard quality prescribed by Sec.  165.110(c). 
Section 402(a)(3) of the act provides another basis for adulteration if 
the food item ``consists in whole or in part of any filthy, putrid, or 
decomposed substance, or if it is otherwise unfit for food.'' Section 
402(a)(3) would apply, for example, in situations where bottled water 
is found to be contaminated with E. coli. Section 165.110(d) would be 
revised by adding the phrase ``consists in whole or in part of any 
filthy, putrid, or decomposed substance, or if it is otherwise unfit 
for food under section 402(a)(3)'' between the words ``402(a)(1)'' and 
``the act.'' To clarify the applicability of Sec.  165.110(d) in cases 
involving E. coli, Sec.  165.110(d) also would be revised by adding the 
statement: ``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 notes that although the regulations as proposed would specifically 
identify section 402(a)(1) and (a)(3) as applicable to bottled water, 
other adulteration provisions in section 402 of the act, such as 
section 402(a)(4) (insanitary conditions) apply as well.

C. CGMP Regulations for Bottled Water

    FDA is proposing in Sec.  129.35(a)(3)(i) that bottled water 
manufacturers that obtain their source water from other than a PWS test 
their source water at least weekly for total coliform and that they 
conduct followup testing for E. coli when source water is total 
coliform positive. Further, 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). To make these changes, FDA 
would revise the CGMP regulations by replacing the phrase 
``microbiological contaminants'' with the phrase ``total coliform'' in 
the second sentence of Sec.  129.35(a)(3)(i), and by adding the 
following two sentences to the section: ``If any coliform organisms are 
detected, followup testing must be conducted to determine whether any 
of the coliform organisms are Escherichia coli * * * 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.''
    FDA is also proposing that a bottler could not use source water 
found to contain E. coli for production of bottled water until the 
bottler has rectified or otherwise eliminated the source water 
contamination, and the source water has been sufficiently retested such 
that it can be considered negative for E. coli. To make these changes, 
FDA would revise the CGMP regulations by adding the following sentences 
to Sec.  129.35(a)(3)(i): ``The bottler must take appropriate measures 
to rectify or otherwise eliminate the cause of E. coli contamination in 
a manner sufficient to prevent its reoccurrence. Source water 
previously found to contain E. coli will 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.''
    In addition, FDA is also proposing to require that bottlers 
maintain records of corrective measures taken to rectify or eliminate 
E. coli contamination. To make this change, FDA is revising Sec.  
129.35(a)(3)(i) to include ``records describing corrective measures 
taken in response to a finding of E. coli'' among the records required 
to be maintained on file at bottled water plants. Finally, FDA would 
revise Sec.  129.35(a)(4)(iv) to include a reference to the potential 
application of section 402(a)(3) of the act as a basis for 
adulteration, in

[[Page 53782]]

addition to section 402(a)(1), for the reasons discussed previously.

D. Analytical Methods for E. coli Testing

    In the GWR, EPA listed numerous analytical methods that it had 
approved for use by PWSs for monitoring source water for E. coli, 
enterococci, and coliphage. However, FDA is not proposing to adopt new 
analytical methods or to change the allowable levels or testing 
requirements for total coliform in the current microbiological standard 
of quality for bottled water. The MTF and MF methods cited in Sec.  
165.110(b)(2) would still be appropriate for total coliform testing. 
The MTF and MF methods are not presence/absence methods, but allow 
enumeration of total coliform levels, unlike some of the methods 
approved by EPA in the GWR. The MTF and MF methods also can be used for 
followup E. coli testing, if needed. Therefore, FDA is proposing to 
cite the existing MTF and MF methods for both total coliform and E. 
coli testing in the new Sec.  165.110(b)(2)(ii). FDA notes that 
bottlers can use different methods approved by the government agency or 
agencies having jurisdiction, if they desire. However, FDA will use the 
MTF and MF methods when it tests products and bottlers that want to use 
different methods must ensure that their methods give comparable 
results.

E. Monitoring and Recordkeeping Provisions of CGMP Regulations for 
Bottled Water

    Under proposed Sec.  129.35(a)(3)(i) in the CGMP regulations, all 
source waters other than from a PWS would have to be analyzed by 
bottled water plants for total coliform at least once each week. 
Bottlers would also be required to test for E. coli, if any coliform 
organisms are detected in the source water. If E. coli is detected in 
the source water, bottlers would also be required to rectify or 
otherwise eliminate the source water contamination and subsequently 
retest for E. coli. In addition, under proposed Sec.  129.80(g)(1) in 
the CGMP regulations, bottlers would have to test finished products for 
total coliform at least once a week, and for E. coli, if any coliform 
organisms are detected in the finished bottled water.
    Section 129.80(h) of the CGMP regulations currently provides that 
all records required under part 129 shall be maintained at the plant 
for not less than 2 years and shall be available for official review at 
reasonable times. The required records include records of analytical 
results for microbiological tests of both source and finished bottled 
water. Section 129.80(h) would apply to the new testing requirements 
for total coliform and E. coli for source water and finished bottled 
water, as well as new recordkeeping relating to measures taken to 
rectify or otherwise eliminate source water contamination, as discussed 
previously.

V. Legal Authority

    FDA is proposing changes to both the bottled water standard (Sec.  
165.110) and the bottled water CGMP regulations (part 129). The 
proposed microbiological quality standard for E. coli in finished water 
is authorized under sections 401 and 410 of the act. Section 401 of the 
act explicitly provides for the issuance of standards of quality. 
Further, section 410(b)(1) of the act requires that not later than 180 
days before the effective date of an NPDWR issued by EPA for a 
contaminant under section 1412 of the 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.
    Section 410(b)(3) of the act requires the standard of quality for a 
contaminant in bottled water to be no less stringent than EPA's MCL and 
no less protective of the public health than EPA's treatment technique 
requirements for the same contaminant. In addition, section 410(b)(2) 
of the act provides that a standard of quality regulation issued by FDA 
shall include monitoring requirements that the agency determines to be 
appropriate for bottled water.
    On November 8, 2006, EPA published an NPDWR to provide for 
increased protection against fecal microbiological pathogens in PWSs 
that use ground water sources. FDA tentatively concludes that this 
proposed rule, if finalized, 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 
EPA for public drinking water.
    FDA is proposing to revise Sec.  165.110(d), Adulteration, of the 
bottled water standard to provide that bottled water containing E. coli 
is deemed to be adulterated under section 402(a)(3) of the act. Under 
section 402(a)(3), a food is deemed adulterated if ``it consists in 
whole or in part of any filthy, putrid, or decomposed substance, or if 
it is otherwise unfit for food.'' As EPA recognized in its GWR, water 
that contains E. coli is fecally contaminated. Such water consists in 
part of a ``filthy'' or ``putrid'' substance under section 402(a)(3) of 
the act. Therefore, if bottled water products test positive for E. 
coli, the products would be adulterated under section 402(a)(3) of the 
act.
    In addition to the change to the bottled water standard, FDA is 
proposing to amend the bottled water CGMP regulations. FDA is proposing 
to amend the current requirement in Sec.  129.35(a)(3)(i) of the CGMP 
regulations to test source water obtained from other than a PWS for 
microbiological contaminants to specifically identify total coliform as 
the contaminant subject to mandatory testing. Such testing for total 
coliform is currently required for finished bottled water by Sec.  
129.80(g). The presence of any coliform indicates that the water may 
contain E. coli, an indicator of fecal contamination. Therefore, if 
either source water or finished water tests positive for total 
coliform, FDA is proposing to require that the water be tested for E. 
coli (under proposed Sec.  129.35(a)(3)(i) for source water and under 
proposed Sec.  129.80(g)(1) for finished bottled water) to determine 
whether it is fecally contaminated. Source water that is fecally 
contaminated would not be considered water of a safe, sanitary quality 
under the CGMPs, and therefore its use in bottled water would be 
prohibited. Finished bottled water that is fecally contaminated would 
be deemed adulterated under section 402(a)(3), as reflected in proposed 
Sec.  165.110(d) of the bottled water standard.
    After testing indicates that source water is fecally contaminated, 
FDA is proposing to require that bottlers could not use this water for 
production of bottled water until they have rectified or otherwise 
eliminated the source water contamination, and the source water has 
been retested sufficiently to be considered negative for E. coli. FDA 
is further proposing that a source would be considered negative for E. 
coli after five samples collected from the source over a 24-hour period 
are tested and found to be E. coli negative. Failure to remedy the 
cause of the contamination would create the possibility of future 
contamination from the same cause.
    FDA's legal authority for these proposed requirements is based on 
the act's adulteration provisions in section 402(a)(3) and (a)(4), and 
under section 701(a) of the act (21 U.S.C. 371(a)). As described 
previously, water containing E. coli consists in part of a ``filthy'' 
or ``putrid'' substance under section 402(a)(3) and is therefore 
adulterated under section 402(a)(3). Under section 402(a)(4) of the 
act, a food is adulterated ``if it has been prepared, packed, or held

[[Page 53783]]

under insanitary conditions whereby it may have become contaminated 
with filth, or whereby it may have been rendered injurious to health.'' 
Failure to ensure the water is prepared, packed, and held under 
conditions in which water does not become fecally contaminated 
constitutes an insanitary condition and thus renders the water 
adulterated under section 402(a)(4) of the act. Under section 701(a) of 
the act, FDA is authorized to issue regulations for the efficient 
enforcement of the act. A regulation that requires measures to prevent 
bottled water from consisting in part of filth and from being prepared, 
packed, and held under insanitary conditions allows for the efficient 
enforcement of the act.
    FDA's proposal includes a requirement that bottlers maintain 
records of measures taken to address a positive E. coli finding in 
source water. Records of corrective measures are needed for FDA to 
determine compliance with the rule's requirement that bottlers take 
appropriate measures to rectify or otherwise eliminate the cause of E. 
coli contamination in source water. Records would provide assurance to 
both the bottler and FDA that the risk of water becoming fecally 
contaminated is being minimized. Failure to take and document these 
measures would result in a bottler producing water under insanitary 
conditions whereby the water may become contaminated with filth under 
section 402(a)(4) of the act.

VI. Environmental Impact Analysis

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VII. Executive Order 12866 and Regulatory Flexibility Act

A. Preliminary Economic Impact Analysis

    FDA has examined the impacts of the proposed 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 tentatively 
concludes that this proposed rule is not a significant regulatory 
action as defined by 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 tentatively concludes that the proposed rule will not have a 
significant economic impact on a substantial number of small entities. 
FDA requests comment on the impact of this rule on 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 $127 million, using the most current (2006) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.
1. Need for Regulation
    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 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. 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. 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. 1). 
Based on EPA's findings in the GWR, FDA tentatively 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. 2). 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 our proposed regulation. FDA asks for 
comments on these estimates.
2. Regulatory Options
    FDA evaluates three regulatory options in this analysis:
    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

[[Page 53784]]

health, then EPA's GWR will apply to bottled water.
    Option 2. Issue the regulations in this proposed rule, 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 proposed rule. FDA is 
proposing to require 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 would be 
required to test for E. coli. Source water containing E. coli would not 
be considered to be of a safe, sanitary quality and would be prohibited 
from use in the production of bottled water until the bottler has taken 
appropriate measures (as evidenced by records) to rectify or otherwise 
eliminate the cause of the contamination. 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. Finished bottled water 
products containing E. coli will be deemed adulterated.

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 
proposed 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 
followup 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 
(21 CFR 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 followup 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 proposed action. Each requirement of FDA's proposed 
action will be evaluated separately in the