[Federal Register Volume 73, Number 181 (Wednesday, September 17, 2008)]
[Proposed Rules]
[Pages 53775-53793]
From the Federal Register Online via the Government Publishing 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: http://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 http://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 http://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 (http://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 following order:
1. Require that source water currently subject to weekly
microbiological testing be analyzed specifically for total coliform;
2. Require followup 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 (as evidenced by records), and then retest the source
water sufficiently until it 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 proposing to specify 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. 3). 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 also
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 followup testing for E. coli when total coliform
positives occur in source water or finished bottled water products.
As noted previously, FDA proposes to require 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 proposing that if any coliform organisms are detected in source
water or in finished water products, then the bottler must conduct
followup 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 proposal, 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 (as evidenced by records), and then retest the source
water sufficiently until it 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
source water contamination, by keeping records of those actions, and by
retesting the source water sufficiently until it is considered negative
for E. coli. The source water 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.
Finished bottled water products that test positive for E. coli will
be deemed
[[Page 53785]]
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 ((66 FR 35439 at 35440, July 5, 2001) and
(Ref. 1)) and that the other 25 percent obtain their water from PWSs.
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, an estimated 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 and 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. 4). 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 if the test is conducted
in-house or at a commercial laboratory.
Table 1--E. coli Testing Costs per Sample
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labor Hours Cost of Labor Hours
Laboratory Type Hourly Labor for Sample Sample for Sample Analysis Per Sample Total Costs
Cost Collection Collection Analysis Materials Analysis Cost per Sample
--------------------------------------------------------------------------------------------------------------------------------------------------------
In-house $ 21.44 .5 $ 10.72 .5 $ 8.95 $ 19.67 $ 30.39
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commercial $ 21.44 .5 $ 10.72 0 $ 74.80 $ 74.80 $ 85.52
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 one 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, December 2,
2004). This may overestimate the number of bottlers that will outsource
testing and thus may overestimate the cost of the rule. FDA requests
comment on this assumption.
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
Other 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
------------------------------------------------------------------------
Total 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. 5). FDA requests comments on this
assumption.
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 would include at least weekly testing for total coliform
in source water and finished products, or at least 52 source samples
and 52 finished product samples per year. For example, bottlers whose
source is other than a PWS would have to test their source water at
least once a week and also their finished
[[Page 53786]]
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. 5). 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, three 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
----------------------------------------------------------------------------------------------------------------
A B C (A X B X 6) + (
------------------------------------------------ A X C X 3)
Number of Number of ------------------
Bottlers Bottlers
Testing Both Testing Only
Source and Finished
Cost per Finished Product Total Annual
sample Product ---------------- Costs of E. coli
---------------- Testing
(Six Tests/ (Three Tests/
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
----------------------------------------------------------------------------------------------------------------
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 would 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 would 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 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. 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.
This cost model assumes that bottlers will take action to rectify
or eliminate source water 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. 6). 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
------------------------------------------------------------------------
[[Page 53787]]
Fraction of bottlers with potential source water 0.0077
contamination ( 17 percent/22 years)
------------------------------------------------------------------------
Number of bottlers that must rectify contamination 2.5
each year over a 22-year period
------------------------------------------------------------------------
As stated earlier, source water 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 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 the retesting is
conducted in-house or in a commercial laboratory, total annual costs of
retesting five 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 Retesting Five More Samples for E. coli
After a Positive Finding\1\
------------------------------------------------------------------------
A B A X B X 5
----------------------------------------------
Total Annual
Number of Costs of
Cost per Bottlers Retesting Five
Sample Retesting Samples for E.
Source Water coli
------------------------------------------------------------------------
In-house laboratory $30 2.5 $380
------------------------------------------------------------------------
Commercial laboratory $86 2.5 $1,069
------------------------------------------------------------------------
\1\ Estimates are not exact due to rounding.
Costs to Rectify Source Water Contamination
As noted previously, FDA requires bottlers to rectify or otherwise
eliminate the source water contamination. FDA drew on EPA's Economic
Impact Analysis of the GWR to provide estimates for costs of rectifying
or eliminating contamination. 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). Unit costs for these repairs are
based on the Technology and Cost Documents for the Final GWR (Ref. 6)
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
will rectify costs of
Action Unit cost Distribution a rectifying
of actions contaminated contaminated
source each sources
year
----------------------------------------------------------------------------------------------------------------
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. 6).
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
[[Page 53788]]
has not quantified these costs and requests comments.
Recordkeeping Costs
Under this proposed rule, those bottlers that would be 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) would be required to maintain a record of the
microbiological test results for at least 2 years under proposed Sec.
129.35(a)(3)(i), as well as current Sec. 129.80(g) and (h) of the CGMP
regulations. The current CGMP regulations already reflect the time and
associated recordkeeping costs for those bottlers that are required to
conduct microbiological testing of their source water, as well as total
coliform testing of their finished bottled water products. FDA
tentatively concludes that any additional costs in recordkeeping based
on the new proposed testing requirements for source water and finished
bottled water products would be negligible.
Summary of Costs
Total costs for the proposed action, including the estimated annual
costs for E. coli testing and for rectifying source water
contamination, 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 source water contamination 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)
------------------------------------------------------------------------
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 retesting. Estimated costs to rectify the source water
contamination using low and high cost assumptions appear in table 9 of
this document.
[[Page 53789]]
Table 9--Estimated Total Annual and Discounted Costs to Rectify
Contamination\1\
------------------------------------------------------------------------
Discounted Costs
Costs to Rectify Contamination Annual Costs (20 years at 7
percent)
------------------------------------------------------------------------
Number of bottlers = 2.5
------------------------------------------------------------------------
Total costs to rectify $17,000 $185,000
contamination (low cost)
------------------------------------------------------------------------
Total costs to rectify $22,000 $230,000
contamination (high cost)
------------------------------------------------------------------------
\1\ Estimates are not exact due to rounding.
Retesting 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 Retesting Costs for E.
coli
------------------------------------------------------------------------
Discounted Costs
Retesting Costs Annual Costs (20 years at 7
percent)
------------------------------------------------------------------------
Number of bottlers 2.5 2.5
------------------------------------------------------------------------
Total costs of five additional $380 $4,000
tests if using in-house
laboratory
------------------------------------------------------------------------
Total costs of five additional $1,069 $11,000
tests if using commercial
laboratory
------------------------------------------------------------------------
Table 11 of this document shows the estimated total annual costs of
the proposed rule (Option 3) by adding tables 7, 8, 9, and 10 of this
document to be $134,000 (low cost) and $189,000 (high cost). The
estimated total discounted or present value costs (using 7 percent
interest rate over 20-year period) are $1.4 million (low) and $1.9
million (high).
Table 11--Estimated Total Annual and Discounted Costs of Proposed Rule
------------------------------------------------------------------------
Total Discounted
Total Annual Costs of Proposed
Costs of Proposed Rule (20 years
Rule 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 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 microbial quality of bottled water 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 proposed 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. This rule may have a significant economic impact on a
substantial number of 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, December 2, 2004). 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
[[Page 53790]]
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\1\
------------------------------------------------------------------------
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 $285 $407
and finished products
------------------------------------------------------------------------
E. coli testing finished product $50 $70
only
------------------------------------------------------------------------
E. coli retesting $1 $3
------------------------------------------------------------------------
Costs to rectify contamination $50 $60
------------------------------------------------------------------------
Average costs per bottler $380 $540
------------------------------------------------------------------------
\1\ Estimates are not exact due to rounding.
To investigate the potential significance of these impacts, FDA
entered these costs into a model created under contract by Eastern
Research Group, Inc. (ERG) (Ref. 7). 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
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.
VIII. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). A description of these provisions is given in
the following paragraphs with an estimate of the annual recordkeeping
burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Recordkeeping Due to New Testing Requirements for Bottled
Water.
Description: The FDA is proposing to amend its bottled water
regulations by requiring testing for the fecal indicator E. coli if any
coliform organisms are detected in a weekly sample of finished bottled
water products. FDA also is proposing to amend the adulteration
provision of the bottled water standard to indicate that finished
product that tests positive for E. coli will be deemed adulterated
under section 402(a)(3) of the act. In addition, FDA is proposing to
amend the CGMP regulations for bottled water by requiring that source
water from other than a PWS be tested at least weekly for total
coliform. If any coliform organisms are detected in the source water,
the bottled water manufacturer would be required to test the source
water for E. coli. Source water found to contain E. coli would not be
considered water of a safe, sanitary quality and would be unsuitable
for bottled water production 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.
Description of Respondents: This rule would require both domestic
and foreign bottled water manufacturers that sell bottled water in the
United States to maintain records of E. coli testing in addition to
existing recordkeeping requirements.
Burden: FDA estimates the burden for this information collection in
table 13 of this document as follows:
Table 13--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Recordkeepers Frequency per Total Annual Hours per Total Hours
Record Records Record
----------------------------------------------------------------------------------------------------------------
Sec. 129.35(a)(3)(i), 319 (bottlers subject to 6 1,914 0.08 153
Sec. 129.80(h) source water and
finished product
testing)
----------------------------------------------------------------------------------------------------------------
[[Page 53791]]
Sec. 129.80(g), Sec. 95 (bottlers testing 3 285 0.08 23
129.80(h) finished product only)
----------------------------------------------------------------------------------------------------------------
Sec. 129.35(a)(3)(i), 2.5 (bottlers retesting 5 12 0.08 1
Sec. 129.80(h) source water)
----------------------------------------------------------------------------------------------------------------
Sec. 129.35(a)(3)(i), 2.5 (bottlers rectifying 3 7.5 .25 2
Sec. 129.80(h) source water
contamination)
----------------------------------------------------------------------------------------------------------------
Total annual burden 179
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The current CGMP regulations already reflect the time and
associated recordkeeping costs for those bottlers that are required to
conduct microbiological testing of their source water, as well as total
coliform testing of their finished bottled water products. FDA
tentatively concludes that any additional burden and costs in
recordkeeping based on the new proposed testing requirements for source
and finished bottled water would be negligible. FDA estimates that the
labor burden of keeping records of each test is about 5 minutes per
test. FDA is also requiring followup testing of source water and
finished bottled water products for E. coli when total coliform
positives occur. FDA expects that 319 bottlers that use sources other
than PWSs may find a total coliform positive sample about three times
per year in source testing and about three times in finished product
testing, for a total of 153 hours recordkeeping. In addition to the 319
bottlers, about 95 bottlers that use PWSs may find a total coliform
positive sample about three times per year in finished product testing,
for a total of 23 hours of recordkeeping. Upon finding a total coliform
sample, bottlers will then have to conduct a followup test for E. coli.
FDA expects that recordkeeping for the followup test for E. coli
will also take about 5 minutes per test. As shown in table 13 of this
document, FDA expects that 2.5 bottlers per year will have to carry out
the additional E. coli testing, with a burden of 1 hour. These bottlers
will also have to keep records about rectifying the source
contamination, for a burden of 2 hours. For all expected total coliform
testing, E. coli testing, and source rectification, FDA estimates a
total burden of 179 hours.
The information collection provisions of this proposed rule have
been submitted to OMB for review. Interested persons are requested to
fax comments regarding information collection by October 17, 2008, to
the Office of Information and Regulatory Affairs, OMB. To ensure that
comments on information collection are received, OMB recommends that
written comments be faxed to the Office of Information and Regulatory
Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.
IX. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed revisions to the standard of quality for bottled water
relating to microbiological quality (21 CFR 165.110(b)(2)), if
finalized as proposed, would have a preemptive effect on State law.
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(a)(1) of the act
(21 U.S.C. 343-1(a)(1)) 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)). Although the proposed
revisions relating specifically to the standard of quality for bottled
water, if finalized as proposed, will have preemptive effect in that it
would preclude States from issuing requirements for microbiological
testing in bottled water that are not identical to the microbiological
testing requirements as set forth in this proposed rule, this
preemptive effect is consistent with what Congress set forth in section
403A of the act.
Section 4(c) of the Executive order further requires that ``any
regulatory preemption of State law shall be restricted to the minimum
level necessary'' to achieve the regulatory objective. Under section
410 of the act, 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. Further, section 410(b)(3) of the act requires a
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 techniques required for the same contaminant. On
November 8, 2006, EPA issued an NPDWR containing a risk-targeted
approach, including treatment techniques, identifying and targeting
GWSs susceptible to fecal contamination (71 FR 65574). FDA has
determined that establishing new microbiological testing requirements
and standards for source water and bottled water products is
appropriate as a response to EPA's action, and is issuing this proposed
regulation consistent with section 410 of the act.
Further, section 4(e) of the Executive order provides that ``when
an agency proposes to act through adjudication or rulemaking to preempt
State law, the agency shall provide all affected State and local
officials notice and an opportunity for appropriate participation in
the proceedings.'' Given the statutory framework of section 410 of the
act for bottled water, EPA's issuance of the GWR provided notice of
[[Page 53792]]
possible FDA action to revise the microbiological quality standard for
bottled water. FDA did not receive any correspondence from State and
local officials regarding possible changes to the microbiological
quality standard for bottled water subsequent to EPA's issuance of the
GWR. In addition, we are providing an opportunity for State and local
officials to comment on proposed changes to the CGMPs and quality
standard in the context of this rulemaking. For the reasons set forth
previously in this document, the agency believes that it has complied
with all of the applicable requirements under the Executive order.
In conclusion, FDA has determined that the preemptive effects of
this rule, if finalized, will be consistent with Executive Order 13132.
X. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
XI. Effective Date of the Related Final Rule
The agency intends to make any final rule based on this proposal
effective December 1, 2009. The agency will publish a final rule in the
Federal Register no later than 180 days before the effective date. The
agency is providing 180 days before the effective date to permit
affected firms adequate time to take appropriate steps to bring their
product into compliance with the standard imposed by the new rule.
XII. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the 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. International Bottled Water Association, 2007. Personal
communication. August 30, 2007.
2. Skipton, S.O., D. Hay, and J.A. 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.
3. International Bottled Water Association, 2005, IBWA Model
Code, Version March 2005. Accessed online at http://www.bottledwater.org/public/pdf/IBWA05ModelCode_Mar2.pdf.
4. Economic Analysis for the Final Groundwater Rule, Office of
Water (4606-M) EPA 85-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.
5. Economic Analysis for the Final Groundwater Rule, Office of
Water (4606-M) EPA 85-R-06-014, October 2006, Section 4.2.7
Triggered Monitoring Baseline, pp. 4-21 through 4-22. 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 85-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.
7. ERG (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.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 129 and 165 be amended as follows:
PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
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.
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 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, followup
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. 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. 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 Federal Food, Drug, and Cosmetic Act
dealing with adulterated foods.
* * * * *
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
[[Page 53793]]
production. The representative sample shall consist of primary
containers of product or unit packages of product. If any coliform
organisms are detected, followup testing must be conducted to determine
whether any of the coliform organisms are E. coli.
* * * * *
PART 165--BEVERAGES
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.
5. Section 165.110 is amended by revising paragraphs (b)(2),
(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. No E. coli shall be detected. 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) method described in the
applicable sections of ``Standard Methods for the Examination of Water
and Wastewater,'' 20th Ed. (1998), 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. You may inspect a copy at the Center for
Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy.,
College Park, MD 20740, 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.
* * * * *
(c) * * *
(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 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: September 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21619 Filed 9-16-08; 8:45 am]
BILLING CODE 4160-01-S