National Primary Drinking Water Regulations: Drinking Water Regulations for Aircraft Public Water Systems, 19320-19348 [E8-7035]
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Federal Register / Vol. 73, No. 69 / Wednesday, April 9, 2008 / Proposed Rules
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 141
[EPA–HQ–OW–2005–0025; FRL–8551–3]
RIN 2040–AE84
National Primary Drinking Water
Regulations: Drinking Water
Regulations for Aircraft Public Water
Systems
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
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AGENCY:
SUMMARY: The Environmental Protection
Agency is proposing to amend and
consolidate in one place the federal
drinking water requirements (known as
National Primary Drinking Water
Regulations or NPDWRs) for aircraft
public water systems under the Safe
Drinking Water Act (SDWA). Aircraft
public water systems are subject to the
requirements of SDWA and the
NPDWRs. The existing federal drinking
water standards were primarily
designed to regulate water quality in
stationary public water systems and the
application of these requirements to
mobile water systems with the
capability of flying throughout the
world has created implementation
challenges. The proposed requirements
are intended to tailor existing healthbased drinking water standards to the
unique characteristics of aircraft public
water systems for the enhanced
protection of public health against
illnesses attributable to microbiological
contamination. This is accomplished
through multiple-barrier protection and
procedural control measures. EPA
believes that the combination of these
components will better protect public
health while building upon existing
aircraft operations and maintenance
programs, better coordinate federal
programs that regulate aircraft water
systems, and minimize disruption of
aircraft flight schedules.
DATES: Comments must be received on
or before July 8, 2008. Under the
Paperwork Reduction Act, comments on
the information collection provisions
must be received by OMB on or before
May 9, 2008.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OW–2005–0025, by one of the following
methods:
• https://www.regulations.gov: Follow
the on-line instructions for submitting
comments.
• E-mail: ow-docket@epa.gov.
• Mail: Water Docket, Environmental
Protection Agency, Mailcode: 2822T,
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1200 Pennsylvania Ave., NW.,
Washington, DC 20460. In addition,
please mail a copy of your comments on
the information collection provisions to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget (OMB), Attn: Desk Officer for
EPA, 725 17th St., NW., Washington, DC
20503.
• Hand Delivery: EPA Docket Center,
Public Reading Room, EPA
Headquarters West Building, Room
3334, 1301 Constitution Ave., NW.,
Washington, DC 20460. Such deliveries
are only accepted during the Docket’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–OW–2005–
0025. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or e-mail. The
https://www.regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
www.regulations.gov your e-mail
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses.
Docket: All documents in the docket
are listed in the https://
www.regulations.gov index. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
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materials are available either
electronically in https://
www.regulations.gov or in hard copy at
the Water Docket, EPA/DC, EPA West,
Room 3334, 1301 Constitution Ave.,
NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the Water Docket is (202)
566–2426.
FOR FURTHER INFORMATION CONTACT:
Richard Naylor, Drinking Water
Protection Division, Office of Ground
Water and Drinking Water (MC–4606M),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460; telephone number: (202)
564–3847; e-mail address:
naylor.richard@epa.gov. For general
information, contact the Safe Drinking
Water Hotline, telephone number: (800)
426–4791. The Safe Drinking Water
Hotline is open Monday through Friday,
excluding legal holidays, from 10 a.m.
to 4 p.m., Eastern time.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
Entities potentially regulated by the
proposed Aircraft Drinking Water Rule
include air carriers that operate aircraft
public water systems using finished
surface water, finished ground water
under the direct influence of surface
water (GWUDI), or finished ground
water. Regulated categories and entities
include:
Category
Scheduled
passenger
air transportation.
Nonscheduled
chartered
passenger
air transportation.
NAICS code
Examples of
regulated
entities
481111
Air carriers.
481211
Air carriers.
This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
regulated by this action. This table lists
the types of entities that EPA is now
aware could potentially be regulated by
this action. Other types of entities not
listed in this table could also be
regulated. To determine whether your
air carrier is regulated by this action,
you should carefully examine the
applicability criteria in section
§ 141.800 of this proposed rule. If you
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have questions regarding the
applicability of this action to a
particular entity, consult the person
listed in the preceding section entitled
FOR FURTHER INFORMATION CONTACT.
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B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through https://
www.regulations.gov or e-mail. Clearly
mark the part or all of the information
that you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for Preparing Your Comments.
When submitting comments, remember
to:
• Identify the rulemaking by docket
number and other identifying
information (subject heading, Federal
Register date and page number).
• Follow directions—The agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
• Explain why you agree or disagree,
suggest alternatives, and substitute
language for your requested changes.
• Describe any assumptions and
provide any technical information and/
or data that you used.
• If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
• Provide specific examples to
illustrate your concerns, and suggest
alternatives.
• Explain your views as clearly as
possible.
• Make sure to submit your
comments by the comment period
deadline identified.
C. Abbreviations Used in This Notice
ADWR: Aircraft Drinking Water Rule.
ANSI: American National Standards
Institute.
AOC: Administrative Order on Consent.
ATA: Air Transport Association.
BMP: Best Management Practice.
CDC: Centers for Disease Control and
Prevention.
CFR: Code of Federal Regulations.
CRMP: Comprehensive Representative
Monitoring Plan.
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CWS: Community Water System.
DBP: Disinfection Byproducts.
E. Coli: Escherichia coli.
EO: Executive Order.
EPA: United States Environmental Protection
Agency.
FAA: United States Federal Aviation
Administration.
FDA: United States Food and Drug
Administration.
FR: Federal Register.
GWS: Ground Water System.
GWUDI: Ground Water Under the Direct
Influence of Surface Water.
HACCP: Hazard Analysis and Critical Control
Point.
HHS: Department of Health and Human
Services.
HPC: Heterotrophic Plate Count.
ICC: Interstate Carrier Conveyance.
ICR: Information Collection Request.
IESWTR: Interim Enhanced Surface Water
Treatment Rule.
LIMS: Laboratory Information Management
System.
mL: Milliliters.
MCL: Maximum Contaminant Level.
MCLG: Maximum Contaminant Level Goal.
MDRL: Maximum Disinfectant Residual
Level.
mg/L: Milligrams per Liter.
NASA: National Aeronautics and Space
Administration.
NCWS: Non-Community Water System.
NDWAC: National Drinking Water Advisory
Committee.
NPDWR: National Primary Drinking Water
Regulation.
NSF: NSF International.
NTNCWS: Non-Transient Non-Community
Water System.
NTTAA: National Technology Transfer and
Advancement Act.
PWS: Public Water System.
OMB: Office of Management and Budget.
QAPP: Quality Assurance Project Plan.
RFA: Regulatory Flexibility Act.
SAB: Science Advisory Board.
SBA: Small Business Association.
SDWA: Safe Drinking Water Act.
SDWIS: Safe Drinking Water Information
System.
SWTR: Surface Water Treatment Rule.
TC: Total Coliform.
TCR: Total Coliform Rule.
TNCWS: Transient Non-Community Water
System.
TT: Treatment Technique.
UMRA: Unfunded Mandates Reform Act.
WHO: World Health Organization.
WSG: Water Supply Guidance.
WSP: Water Safety Plan.
D. Table of Contents
I. General Information
II. Background
A. Legal Authority
B. Purpose of the Proposed Rule
C. Scope of Proposed Rule
D. Potential Health Concerns Associated
With Aircraft Water Systems
E. Regulatory and Enforcement History
III. Proposed Rule Development
A. Stakeholder Involvement
B. Data Collection Efforts
C. Framework for Proposed Rule
Development
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IV. Elements of the Proposed Aircraft
Drinking Water Rule
A. Sampling Requirements
B. Responses to Sample Results
C. Aircraft Water System Operation and
Maintenance Plan
D. Notification Requirements to Passengers
and Crew
E. Reporting Requirements
F. Recordkeeping Requirements
G. Audit and Self-Inspection Requirements
H. Supplemental Treatment
I. Violations
J. Compliance Date
V. Cost Analysis
A. Summary of Regulatory Alternatives
Considered
B. National Cost Estimates
C. Comparison of Cost of Regulatory
Alternatives
D. Estimated Impacts of Proposed Rule to
Air Carrier Passengers
E. Non-quantified Costs and Uncertainties
VI. Relative Risk Analysis and Benefits
A. Relative Risks—Qualitative Analysis
B. Assessment of Potential Quantitative
Relative Risk Analyses
C. Non-quantified Benefits
VII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation
and Coordination With Indian
Governments
G. Executive Order 13045: Protection of
Children from Environmental Health and
Safety Risks
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
I. National Technology Transfer and
Advancement Act
J. Executive Order 12898: Federal Actions
To Address Environmental Justice in
Minority Populations or Low-Income
Populations
K. Consultations with the Science
Advisory Board, National Drinking
Water Advisory Council, and the
Secretary of Health and Human Services
L. Plain Language
VIII. References
II. Background
A. Legal Authority
EPA is proposing this regulation
under the authority of the Safe Drinking
Water Act (SDWA), as amended, 42
U.S.C. 300f et seq., primarily sections
1401, 1411, 1412 and 1450. Under
SDWA, EPA establishes minimum
requirements for tap water provided to
the public, known as the National
Primary Drinking Water Regulations or
NPDWRs; these standards are applicable
to ‘‘public water systems.’’ SDWA
Section 1401 and EPA’s regulations
define a ‘‘public water system’’ (PWS) as
a system for providing water for human
consumption to the public through
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pipes or other constructed conveyances
and that regularly serves an average of
a least twenty-five individuals daily, at
least 60 days per year. 40 CFR 141.2.
All public water systems are subject
to the NPDWRs unless they are
excluded from regulatory requirements
under SDWA Section 1411. Section
1411 excludes from regulation any
public water system that receives all its
water from another regulated public
water system, does not sell or treat the
water, and is not a ‘‘carrier which
conveys passengers in interstate
commerce.’’ The classes of interstate
carrier conveyances (ICCs) include
aircraft, trains, buses, and water vessels.
As a result, all ICCs that regularly serve
water to an average of at least twentyfive individuals daily, at least 60 days
per year are public water systems and
are currently subject to existing
NPDWRs regardless of whether they
treat or sell the water. Due to the unique
characteristics of aircraft water systems
and demonstrated implementation
challenges, EPA has decided that a new
NPDWR specifically tailored to aircraft
water systems is necessary and an
Agency priority. EPA may decide to
tailor existing requirements to other
classes of ICCs in the future.
B. Purpose of the Proposed Rule
The primary purpose of the proposed
Aircraft Drinking Water Rule (ADWR) is
to ensure that safe and reliable drinking
water is provided to aircraft passengers
and crew. This entails providing air
carriers with a feasible way to comply
with SDWA and the NPDWRs. The
existing NPDWRs were designed
primarily with traditional, stationary
public water systems in mind. Some of
these requirements have proven difficult
to implement when applied to aircraft
water systems, which are operationally
very different. For example, aircraft
must maintain rigorous operating
schedules. They fly to multiple
destinations throughout the course of
any given day and may board drinking
water from sources at any of these
destinations. Aircraft board water from
airport watering points via temporary
connections. Aircraft drinking water
safety depends on a number of factors
including the quality of the water that
is boarded from these multiple sources,
the care used to board the water, and the
operation and maintenance of the
onboard water system and the water
transfer equipment (such as water
cabinets, trucks, carts, and hoses). These
unique operational characteristics
present different challenges, which EPA
is addressing in this proposal.
EPA’s NPDWRs establish different
requirements based on the classification
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of the public water system (water
system), including whether the system
is a ‘‘community,’’ ‘‘nontransient
noncommunity,’’ or ‘‘transient
noncommunity’’ system and whether
the system uses surface water or
groundwater. Aircraft public water
systems are considered transient
noncommunity water systems
(TNCWS), because they are not
community water systems and they do
not regularly serve at least 25 of the
same persons over six months per year
(See 40 CFR 141.2). Also, aircraft are
regulated as surface water systems
because they are likely to board finished
drinking water from other public water
systems that use surface water in whole
or in part. EPA considers water for
human consumption to include water
for drinking and food preparation as
well as water for brushing teeth and
hand washing (see 63 FR 41941 (August
5, 1998)). Therefore, if an aircraft has a
sink in the lavatory, then the water
provided to that sink must be suitable
for human consumption.
C. Scope of Proposed Rule
The proposed ADWR only addresses
aircraft regulated under SDWA. SDWA
does not regulate aircraft water systems
operating outside the U.S.; however,
EPA is supporting an international effort
led by the World Health Organization
(WHO) to develop international
guidelines for aircraft drinking water.
The proposed ADWR applies to the
onboard water system only. EPA defers
to the Food and Drug Administration
(FDA) with respect to regulating
watering points such as water cabinets,
carts, trucks, and hoses from which
aircraft board water. Aircraft that do not
provide water for human consumption
or those with water systems that do not
regularly serve an average of at least
twenty-five individuals daily at least 60
days out of the year do not meet the
definition of a public water system;
these aircraft are not regulated under the
NPDWRs or covered under the new
NPDWR proposed today. An estimated
63 air carriers and 7,327 aircraft public
water systems are covered by this
proposal.
D. Potential Health Concerns Associated
With Aircraft Water Systems
The proposed ADWR assumes that
only finished water is boarded on
aircraft. Finished water means water
that is introduced into the distribution
system of a public water system and is
intended for distribution and
consumption without further treatment,
except as necessary to maintain water
quality in the distribution system (e.g.,
supplemental disinfection, addition of
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corrosion control chemicals) (40 CFR
141.2). The assumption that only
finished water is boarded on aircraft is
based on a FDA requirement that only
potable water may be provided for
drinking and culinary purposes on
interstate carrier conveyances (ICCs) (21
CFR 1240.80). Aircraft public water
systems that are boarding water that is
not finished water will continue to be
subject to existing NPDWRs and will not
be subject to the new NPDWR proposed
today. However, even when the water
boarded is finished water, the
opportunity exists for microbiological
organisms to be introduced during the
act of transferring the water from the
supplier truck, cabinet, or cart to the
aircraft water system, or for biofilm to
develop within the water system itself.
The proposed ADWR seeks to protect
against disease-causing microbiological
contaminants or pathogens through the
required development and
implementation of aircraft water system
operation and maintenance plans that
include best management practices, air
carrier training requirements, and
periodic sampling of the onboard
drinking water. Testing drinking water
for each individual pathogen is not
practical, nor feasible. Instead, water
quality and public health professionals
use total coliform bacteria as an
indicator organism. Total coliforms are
a group of closely related, mostly
harmless bacteria that live in soil and
water as well as in the guts of animals.
The presence of total coliforms in
drinking water suggests that there may
be disease-causing agents in the water or
there has been a breach, failure, or other
change in the integrity of the drinking
water. Normally, total coliforms are not
harmful to human health. However, if
Escherichia coli (E. coli), a type of
coliform bacteria, is present, it can be
harmful to human health. Total
coliforms are inactivated, or made
harmless, by treatment or die off
naturally in a manner similar to most
bacterial organisms. However, if total
coliforms are found in a water system,
the system may be vulnerable to
disease-causing bacteria (i.e.,
pathogens), whether pathogens are
actually present or not. If an aircraft
water system is not disinfected and/or
flushed on a routine basis, it may be at
risk for biofilm or other bacterial
growth.
Most of the bacteria in drinking water
distribution systems are associated with
biofilms. There are several studies
showing that pathogenic organisms can
survive longer and have greater
resistance to chlorine when occurring in
biofilms than in drinking water (Lehtola
et al., 2007). Most aircraft water tanks
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are either topped off or drained on a
daily basis. However, there are
occasional situations when the water
may become stagnant. Some examples
are aircraft that are occasionally taken
out of service for an extended
maintenance period, or cold weather
conditions that affect the ability to drain
tanks (due to concerns about the
drained water freezing on the tarmac).
Additionally, aircraft with water in their
tanks that experience long layovers or
overnight stays in high temperature
areas have a higher potential for rapid
growth of organisms. There are no data
on outbreaks of illness caused by
drinking water on aircraft. That does not
mean there is no illness because there
is a high rate of underreporting of
illnesses caused by drinking water
contamination. Illness resulting from
consuming contaminated aircraft water
would be no exception to this because
the population onboard disperses after a
flight and even if passengers develop
gastrointestinal symptoms within hours
of deplaning, they are unlikely to
associate the illness with the aircraft
water or to contact the air carrier or any
government agency to report the illness.
The effects of waterborne disease are
usually acute, resulting from a single or
small number of exposures. Most
waterborne pathogens cause
gastrointestinal illness with diarrhea,
abdominal discomfort, nausea,
vomiting, or other symptoms. Most such
cases involve a sudden onset and
generally are of short duration in
healthy people. Some pathogens (e.g.,
Giardia and Cryptosporidium), however,
may cause extended illness, lasting
weeks or longer in otherwise healthy
individuals. Waterborne pathogens are
particularly harmful to sensitive
populations, such as the immunocompromised, and can sometimes prove
fatal.
E. Regulatory and Enforcement History
SDWA, including the amendments of
1986 and 1996, require EPA to
promulgate NPDWRs to prevent tap
water contamination that may adversely
affect human health. As TNCWSs,
aircraft are subject to certain NPDWRs
specific to this category of systems. EPA
published Water Supply Guidance 29
(WSG 29) in October 1986 to assist ICC
operators, including air carriers, in
complying with these standards (USEPA
1986). WSG 29 described an alternative
under which the operator of an ICC
water system could use an approved
operation and maintenance program in
lieu of monitoring requirements.
However, this guidance did not alter the
regulatory requirements for ICCs. Since
then, EPA has determined that a new
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rule specifically adapted to aircraft
water systems would provide a clearer
and more implementable regulatory
framework for aircraft water systems.
EPA suspended the earlier guidance in
2003 and is no longer approving
operation and maintenance programs in
lieu of monitoring under WSG 29 while
the ICC program is being revised.
In 2004, EPA found all aircraft water
systems to be out of compliance with
the NPDWRs. According to the air
carriers, it is not feasible for them to
comply with all of the monitoring that
is required in the existing regulations.
Subsequently, EPA tested 327 aircraft of
which 15 percent tested positive for
total coliform. In response to these
findings, EPA embarked on a process to
tailor the existing regulations for aircraft
public water systems. In the interim,
EPA placed 45 air carriers under
Administrative Orders on Consent
(AOC) that will remain in effect until
tailored aircraft drinking water
regulations are final. The air carrier
AOCs combine sampling, best
management practices, corrective
action, public notification, and
reporting and recordkeeping to ensure
public health protection.
Many drinking water rules for systems
using surface water or ground water
under the direct influence of surface
water (GWUDI) relate to the treatment of
source water, but because aircraft board
finished water, the responsibility for
treating the water is borne by the water
supplier from which aircraft obtain their
water. This situation is comparable to
traditional, stationary water systems
that are consecutive systems (i.e., buy
finished water from other PWSs). The
proposed ADWR adapts to aircraft water
systems the applicable requirements
from the Total Coliform Rule, the suite
of surface water treatment regulations,
and the Public Notification Rule, the
relevant sections of which are
summarized as follows.
1. The 1989 Total Coliform Rule
The Total Coliform Rule (TCR)
(USEPA, 1989) applies to all public
water systems. Because monitoring
water systems for every possible
pathogenic organism is not feasible,
coliform organisms are used as
indicators of possible source water and
distribution system contamination.
Coliforms are easily detected in water
and are used to indicate a water
system’s source and distribution system
vulnerability to pathogens. In the TCR,
EPA sets a Maximum Contaminant
Level Goal (MCLG) of zero for total
coliforms. EPA also sets a monthly
Maximum Contaminant Level (MCL) for
total coliforms and requires testing of
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total coliform-positive cultures for the
presence of E. coli or fecal coliforms. E.
coli and fecal coliforms indicate more
immediate health risks from sewage or
fecal contamination and are used as a
trigger of acute contamination. In
addition, the TCR requires sanitary
surveys (i.e., onsite review of the water
source, facilities, equipment, operation
and maintenance of a PWS for the
purpose of evaluating the adequacy of
such source, facilities, equipment,
operation and maintenance for
producing and distributing safe drinking
water). The TCR requires sanitary
surveys by the State primacy agency
every 5 years for systems that collect
fewer than 5 total coliform samples per
month (those serving 4,100 people or
fewer). A TNCWS using surface water
serving less than 1,000 persons daily
would typically be required to take one
total coliform sample per month for
routine sampling requirements.
2. Surface Water Treatment Regulations
EPA has promulgated a suite of
regulations to address microbiological
contamination of surface water. These
regulations include the Surface Water
Treatment Rule (SWTR), the Interim
Enhanced Surface Water Treatment Rule
(IESWTR), the Filter Backwash
Recycling Rule, and the Long Term 1
and Long Term 2 Enhanced Surface
Water Treatment Rules. These rules
apply monitoring and treatment
technique requirements to protect the
public from microbiological pathogens
in drinking water such as bacteria,
viruses, Giardia lamblia, and
Cryptosporidium. The monitoring and
treatment technique requirements must
be met prior to water entering the
distribution system. Aircraft which
board only finished water are not
required to provide source water
treatment or to perform monitoring of
source water because these activities are
the responsibility of the public water
system from which the aircraft obtains
finished water for boarding. However,
the SWTR includes provisions for
maintaining a detectable distribution
system disinfectant residual and for
monitoring distribution system
disinfectant residuals at the same time
and location as used for total coliform
monitoring. Because disinfectant
residual monitoring is required in the
distribution system, current regulations
require aircraft to perform this
monitoring. A TNCWS using surface
water serving less than 1,000 persons
daily would typically be required to
take one disinfectant residual sample
per month. Additionally, the IESWTR
requires primary enforcement agencies
to conduct sanitary surveys for all
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surface water and GWUDI systems
regardless of size, and specifies a
frequency of every 5 years for
noncommunity water systems.
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3. The Public Notification Rule
Public water systems must give notice
to persons served by the water system
for violations of NPDWRs and for other
situations posing a risk to public health
from drinking water. The term ‘‘NPDWR
Violations’’ is used in the public
notification regulations to include
violations of the MCL, Maximum
Residual Disinfectant Level (MRDL),
treatment technique (TT), monitoring,
and testing procedure requirements.
Public notice requirements are divided
into three tiers, which take into account
the seriousness of the violation or
situation and of any potential adverse
health effects that may be involved. Due
to the transient nature of the public
served by TNCWSs, public notice is
typically provided through posting of
the notice at locations where the public
may access drinking water from the
water system.
4. Roles of the FAA and FDA in
Regulating Aircraft Drinking Water
Drinking water safety on air carriers is
jointly regulated by the EPA, the Food
and Drug Administration (FDA), and the
Federal Aviation Administration (FAA).
EPA regulates the parent public water
systems within the United States that
supply water to the airports and the
drinking water once it is onboard the
aircraft. EPA is responsible for
developing and implementing the
NPDWRs for all public water systems,
including public water systems on
aircraft. FAA requires that air carrier
companies submit operation and
maintenance programs (14 CFR part 43,
14 CFR part 91, 14 CFR part 121) for all
parts of the aircraft, including the water
system. Under the current
Memorandum of Understanding
between EPA and FDA, the FDA takes
the lead in regulating culinary water
and the watering points where aircraft
obtain water at the individual airports.
FDA is responsible for approving all ICC
watering points (21 CFR 1240.83(a)), (1)
to ensure the water supply meets EPA’s
NPDWRs and (2) to ensure the methods
(i.e., water transfer process) of and
facilities (e.g., water cabinets, carts,
trucks, containers, and hoses) for
delivery of such water to the
conveyance and the sanitary conditions
surrounding such delivery prevent the
introduction, transmission, or spread of
communicable diseases.
In addition to the EPA and FDA
requirements, air carriers have many
different on-going programs and
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practices for assessing and correcting
deficiencies and risks associated with
the drinking water supply and related
safety, security and sanitation issues.
Such programs and practices may
include FAA Airworthiness Standards:
Transport Category Airplanes
(airworthiness maintenance and
inspection program) (14 CFR part 43, 14
CFR part 91, and 14 CFR part 121);
vulnerability assessments/security
programs; FDA regulations for Interstate
Conveyance Sanitation (USFDA 2005);
FDA sanitary surveys of watering points
and servicing areas; and FDA
certification of aircraft sanitation
systems including potable (finished)
water, sewage, and galleys. These
programs may contribute valuable
information related to the condition of
the aircraft water system and water
quality. EPA has worked closely with
FDA and FAA to ensure that this
proposal for aircraft water system
regulation is integrated with these
programs to avoid unnecessary
duplication.
III. Proposed Rule Development
A. Stakeholder Involvement
In November 2004, when EPA
announced that it had initiated a
rulemaking process to develop
regulations for aircraft public water
systems, the Agency committed to
working collaboratively with other
federal agencies overseeing the air
carrier industry, industry
representatives, and interested
stakeholders to identify appropriate
requirements to ensure safe drinking
water onboard aircraft. This
collaborative rule development process
has allowed EPA an opportunity to
obtain information from, and hear the
concerns and questions of stakeholders
who would be affected by this rule in an
organized and formal process prior to
development of this proposed rule.
EPA has held three public meetings;
these were held in June 2005, January
2006, and March 2007. All three events
were well-attended by stakeholders
representing a diverse group of interests
including: Air carriers, airports, flight
attendants, pilots, passengers, public
health officials, environmental groups,
states, public water systems, water
treatment and equipment vendors,
laboratories, foreign government
agencies, and other federal agencies
(e.g., FDA, FAA, and CDC).
EPA used a third-party skilled in
conflict resolution to help facilitate the
process and to involve the full range of
interests. Given the number and
complexity of issues associated with
aircraft drinking water, EPA began with
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an assessment process to identify
options to support and engage the full
range of stakeholders in the regulatory
development process.
In June 2005, EPA held a public
information meeting to kick-off the
rulemaking process. The meeting was
followed by the development of a
stakeholder assessment report,
produced by the third-party facilitator,
which is available in the docket for this
rule. This report included
recommendations for a series of joint
education workshops to bring diverse
stakeholders together to identify and
understand the issues and to provide
input and comment on regulatory
approaches and options.
The first workshop was held on
January 18–19, 2006. This workshop
provided an opportunity for
stakeholders to learn about aircraft
water systems and watering points,
current regulations, and other
information relevant to the rulemaking.
The stakeholders were encouraged to
share their initial ideas about the issues
that should be addressed in developing
the proposed rule. EPA also presented
for consideration by the stakeholders a
conceptual approach for the rule, which
draws on the principles of the Hazard
Analysis and Critical Control Point
(HACCP) and multiple barrier
approaches. This systematic approach,
known as the Water Safety Plan (WSP)
approach, is described in greater detail
in section III. C. Framework for
Proposed Rule Development.
The second workshop was conducted
on March 28–29, 2007. At this
workshop, EPA presented for comment
examples of the application of the Water
Safety Plan approach to aircraft water
systems. Also, EPA presented the
preliminary monitoring data collected
under the air carrier Administrative
Orders on Consent. The majority of the
workshop time was spent soliciting
stakeholder input on topics critical to
the development of the ADWR
including monitoring, best management
practices, public and crew notification,
reporting and recordkeeping
requirements, and program oversight
and verification.
B. Data Collection Efforts
In developing the ADWR proposal,
EPA analyzed preliminary monitoring
results submitted under the
Administrative Orders on Consent
(AOCs) from 2005–2007. In addition, to
gain a better understanding of the
drinking water quality on domestic
aircraft as indicated by total coliform,
E.coli/fecal coliform, and chlorine
residual, EPA drew upon the results of
the following three studies: (1) A
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voluntary monitoring study completed
by the Air Transport Association (ATA)
in Fall 2003; (2) an EPA study of aircraft
NPDWR compliance completed in 2004;
and (3) the Canadian Inspection
Program monitoring results completed
in 2006
The EPA data summaries presented
here should not be used to draw any
definitive conclusions. The AOC dataset
is incomplete and therefore considered
preliminary since it represents 15 out of
45 domestic air carriers under AOCs
with EPA. The 45 domestic air carriers
were placed under AOCs to resolve noncompliance with the Safe Drinking
Water Act and the National Primary
Drinking Water Regulations. The AOCs
established interim aircraft water testing
and disinfection protocols. Each of the
air carriers, at a minimum, was required
to implement the following regular
monitoring and disinfection protocols
for its entire fleet: Regular monitoring of
aircraft water systems for coliforms and
disinfectant residuals; regular
disinfection of aircraft water systems
and water transfer equipment; corrective
action for total coliform-positive
sample(s); analysis of any total coliformpositive culture media for the presence
of fecal coliforms or E. coli; provision of
public notice or restriction of water
service when there is a total coliformpositive sample result; performance of a
study of possible sources of
contamination that exist outside of the
aircraft; and inclusion of information
regarding various aspects of its domestic
and foreign water practices.
Specific to the AOC sampling data, air
carriers were required to submit two
documents for EPA approval that set the
stage for monitoring and disinfection
19325
protocols/procedures: A Comprehensive
Representative Monitoring Plan (CRMP)
and a Quality Assurance Project Plan
(QAPP). The CRMP describes the air
carrier’s sampling and disinfection
processes and protocols for collecting
samples within a 12-month period. The
QAPP describes the air carrier’s Quality
Assurance/Quality Control processes to
ensure good quality data and the
methods for collecting and assessing
data, such as use of State- or EPAcertified laboratories and EPA-approved
analytical methods for analyzing
drinking water samples. Once the plans
were approved, air carriers were
required to collect and submit their
aircraft water system sampling data to
EPA. As reflected in Table III–1, air
carriers followed slightly different
monitoring and disinfection protocols
based on their fleet size.
TABLE III–1.—MONITORING AND DISINFECTION PROTOCOLS AS REQUIRED UNDER THE AOCS
Air carriers
with greater
than 20
aircraft
MONITORING 1
For each sample event, collect at least one sample from a galley and one from a lavatory for Total Coliform
(TC) and Disinfectant Residual (total residual chlorine) ......................................................................................
Sample 25% of fleet quarterly .................................................................................................................................
Sample all fleet quarterly .........................................................................................................................................
DISINFECTING AND FLUSHING 2
Disinfect and flush each aircraft’s water system no less than quarterly .................................................................
Disinfect and flush watering points (e.g., water trucks, carts, cabinets, hoses) no less than monthly ..................
Air carriers
with less than
or equal to 20
aircraft
........................
........................
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1 The air carrier was required to use State- or EPA-certified laboratories and EPA-approved analytical methods for analyzing drinking water
samples.
2 If the air carrier has a pre-AOC monitoring and disinfecting program requiring a higher frequency, the air carrier was required to continue in
accordance with their program, unless modification was requested and approved by EPA.
As of May 31, 2007, of the 45 air
carriers under AOCs, EPA has analyzed
preliminary drinking water sampling
data from 15 air carriers consisting of
2,316 aircraft out of an estimated total
fleet size of 5,558. The total number of
samples (routine and repeat) was
12,099. Of these samples, 3.1 percent
(378 samples) were total coliformpositive. Of the 378 total coliformpositive samples, 2.4 percent (9
samples) were E. coli/fecal coliformpositive. Of a total of 7,489 routine
chlorine residual samples taken, 26.1
percent (1,957) resulted in a non-detect.
However, in relating the preliminary
AOC sampling data to other aircraft
water quality studies only the routine
samples were used. Repeat samples
were not used because they by nature
have a higher probability of being total
coliform-positive since repeats are taken
after a routine sample is total coliformpositive. In addition, the other studies
did not take repeat samples, therefore,
the routine samples are most analogous
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to the data collected under the other
studies.
Therefore, in determining an
estimated baseline of domestic air
carrier drinking water quality the
following was observed in the
preliminary AOC data: Out of 7,812
routine samples, 2.8 percent (222
samples) were total coliform-positive.
Of the 222 total coliform-positive
samples, 2.3 percent (5 samples) were E.
coli/fecal coliform-positive. Of the 3,952
routine chlorine residual samples taken,
21.5 percent (848) resulted in a nondetect.
Under a voluntary study coordinated
with EPA, ATA sampled 265 passenger
aircraft operated by eight ATA-member
U.S. air carriers. As noted by ATA, these
eight air carriers represent the majority
of the U.S. commercial passenger fleet,
and serve both domestic and
international routes. The aircraft were
randomly selected and samples were
generally collected from the galley,
except in some cases where the galley
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faucets were equipped with filters,
efforts were made to collect residual
disinfectant samples from the lavatory.
The samples were analyzed for total
coliform (and in the case of a total
coliform-positive result, the sample was
tested for E. coli/fecal coliform), total
residual chlorine, turbidity, total nitrate,
and nitrite. Regarding microbiological
testing, of the 265 aircraft sampled, 2.6
percent (7 aircraft) were total coliformpositive; there were no fecal coliform or
E. coli-positive samples. Water samples
from forty-one percent of the aircraft
had non-detectable chlorine residuals
(ATA 2003).
In the 2004 EPA NPDWR Compliance
study, 327 passenger aircraft belonging
to ATA and non-ATA members were
randomly tested at 12 U.S. airports that
served both domestic and international
routes. EPA analyzed the drinking water
samples from galleys and lavatories for
total coliform (and in the case of a total
coliform-positive result, the sample was
tested for E. coli/fecal coliform), total
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residual chlorine, heterotrophic plate
count, total nitrate, and nitrite. In regard
to microbiological presence, 15 percent
(49/327) of the aircraft tested positive
for total coliform, and 4.1 percent (2/49
aircraft) of these total coliform positive
aircraft also tested positive for E. coli/
fecal coliform. Twenty-one percent (69/
327) of the aircraft tested had a nondetectable chlorine residual.
Under the Canadian Inspection
Program, Health Canada randomly
inspected 431 aircraft for
microbiological presence in drinking
water. Of the 431 aircraft tested, 15.1
percent (65 aircraft) were total coliformpositive, and 7.7 percent (5/65 aircraft)
of these total coliform positive aircraft
were also E. coli positive. Most of the
contamination (4 samples) was found in
water from the lavatory faucets. The
Canadian study did not test for chlorine
residual (Canada 2007a and 2007b).
It is important to note that the
intended purpose and use of the
preliminary AOC and the other aircraft
sampling results were to protect public
health by providing an understanding of
the quality of airline drinking water.
Although they were not collected to
drive the ADWR rulemaking process,
these datasets provide important
information for an estimated baseline of
aircraft drinking water quality for total
coliform, E. coli/fecal coliform, and
residual chlorine.
Although it is difficult to complete a
one-to-one comparison of the sampling
results among the studies, observed
differences may be attributed to several
factors. For instance, best management
practices and protocols (such as
systematic sampling, disinfecting, and
flushing procedures) established under
the AOCs may have played a part in the
varying results. These systematic
protocols may have created a greater
chance of consistency and effectiveness
among the air carriers in implementing
the operational and maintenance
procedures of an aircraft water system.
In addition, these findings suggest that
best management practices are
important for public health protection.
EPA will continue to collect and
analyze the aircraft sampling data for
the 45 air carriers under the AOCs. EPA
will use the data to improve the
Agency’s understanding of aircraft
drinking water quality relevant to
microbiological controls. A summary of
the final results will be released along
with available sampling data from the
45 air carriers under AOCs. Docket ID
No. EPA–HQ–OW–2005–0025.
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C. Framework for Proposed Rule
Development
For today’s proposal, EPA has
considered both the existing NPDWRs
applicable to aircraft water systems—the
Total Coliform Rule, the Surface Water
Treatment Regulations and the Public
Notification Rule—and a systematic risk
management approach used for food
and water safety by other agencies,
which EPA believes can be particularly
effective when dealing with mobile
sources of drinking water. The resulting
proposed rule is intended to consolidate
the three existing NPDWRs into one
new NPDWR and modify them, based
on the Water Safety Plan approach
described as follows, so that the
drinking water standards can be more
effectively implemented for aircraft
water systems and better integrated with
FDA and FAA programs and
requirements.
1. HACCP and Water Safety Plan
Approaches
EPA believes that an effective means
of assuring safe drinking water onboard
aircraft is through the application of a
systematic risk management approach
referred to as the Water Safety Plan
(WSP) approach. The Water Safety Plan
concept was developed by the World
Health Organization (WHO) as part of
the 3rd edition of its drinking water
guidelines (WHO 2004). It is based on
the Hazard Analysis and Critical Control
Point (HACCP) concepts and the
multiple barrier approach to protecting
public health.
The basic HACCP concepts were
originally developed in 1959 by the
Pillsbury Company with cooperation
and participation from the National
Aeronautics and Space Administration
(NASA), the Natick Laboratories of the
U.S. Army, and the U.S. Air Force Space
Laboratory Project Group. The purpose
was to ensure food and beverage safety
from microbiological hazards for the
first NASA manned space missions.
Since the 1980s, the HACCP system has
been adopted by food and beverage
industries world-wide, where it forms
an important part of their ‘‘food safety
plans.’’ For example, the FDA has
adopted the HACCP system as an
effective approach for its food safety
program. FDA utilized the HACCP
approach in the final rules for the
seafood and juice industries. HACCP
guidelines developed by WHO, known
as Codex Alimentarius, have been
adopted internationally as the primary
recognized food safety methodology for
risk management. The current HACCP
guideline (WHO, 1997) was developed
by the Codex Alimentarius Commission.
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In the multiple barrier approach,
technical and managerial barriers help
prevent contamination at the source,
treatment, distribution, and tap to
provide a safe supply of drinking water
for consumers. The barriers include risk
prevention, risk management,
monitoring and compliance, and
individual action. As an enhancement
of the HACCP approach, the Water
Safety Plan approach identifies control
measures not only at critical control
points, as is done for HACCP, but also
at the point of contamination where the
hazardous event occurs as well as
downstream of the potential
contamination point. The intent is to
enable the effect of the multiple barriers
to be assessed together (Davison et al.,
2005). The Water Safety Plan approach
continues to evolve as the water
industry gains experience by developing
and implementing Water Safety Plans.
2. Proposed Rule Approach
The proposed approach for this
rulemaking effort includes elements of
the HACCP approach and WHO’s Water
Safety Plan approach and builds on the
foundation of the controls established
under the existing NPDWRs applicable
to aircraft water systems. This proposed
regulation does not require each air
carrier to develop its own Water Safety
Plan (WSP). Instead, the WSP approach
was used to outline the priority hazards
and the control measures that could be
implemented to control these hazards in
the entire aircraft water supply and
transfer chain. By looking holistically at
the entire process, EPA ensured a
collaborative working relationship with
other federal agencies overseeing the air
carrier industry. This holistic approach
will minimize duplication of effort and
regulation by multiple federal agencies
over the same segment of the process. It
also helps minimize concerns of overregulation in one segment of a process
to address an issue that could be more
effectively handled in another segment
of the process. Once the hazards and
potential control measures were
identified, EPA could then focus on the
specific area of its jurisdiction, the
onboard water system.
3. Identified Hazard Events and
Potential Control Measures
The following are examples of the
primary hazard events and potential
control measures for aircraft water
systems identified through the WSP
approach.
• Water to be boarded does not meet
NPDWRs applicable to TNCWSs. The
potential control measure is to prevent
boarding of water, if operational needs
(e.g., flushing of toilets) can be met
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without boarding additional water. If
water must be boarded, appropriate
control measures are to: Restrict public
access, provide public notification,
including posting notices at lavatory
and galley taps stating that the water is
not for consumption; provide bottled
water for coffee making and drinking;
providing antiseptic alcohol-based hand
gels or wipes for handwashing;
disinfecting and flushing the aircraft
water system as soon as possible; and
demonstrating satisfactory aircraft water
quality through follow-up sampling
before resumption of unrestricted public
access to the aircraft water system.
• Air carrier or aircraft crew is
notified that water already boarded does
not meet NPDWRs applicable to
TNCWSs. The potential control
measures are to: Restrict public access,
provide public notification, including
posting notices at lavatory and galley
taps stating that the water is not for
consumption; providing bottled water
for coffee making and drinking;
providing antiseptic alcohol-based hand
gels or wipes for handwashing;
disinfecting and flushing the aircraft
water system as soon as possible; and
demonstrating satisfactory aircraft water
quality through follow-up sampling
before resumption of unrestricted public
access to the aircraft water system.
• Use of a watering point, including
transfer and delivery systems, not
approved by FDA. The potential control
measure is for the air carrier to obtain
approval from FDA for new watering
points or when changing watering
points.
• Contamination or cross
contamination due to unsanitary
practices. The potential control
measures are to: Clean and disinfect
hoses, transfer pumps, water trucks, and
other equipment; develop written
standard operating procedures (SOPs)
and provide training for sanitary water
transfer practices and aircraft cleaning;
conduct total coliform monitoring;
restrict public access, provide public
notification, including posting notices at
lavatory and galley taps stating that the
water is not for consumption; providing
bottled water for coffee making and
drinking; providing antiseptic alcoholbased hand gels or wipes for
handwashing; disinfecting and flushing
the aircraft water system as soon as
possible; and demonstrating satisfactory
aircraft water quality through follow-up
sampling before resumption of
unrestricted public access to the aircraft
water system; and conducting audits or
inspections.
• Backflow from unprotected cross
connection, failure of backflow
prevention devices, or cross
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contamination from water line break.
The potential control measures are to:
Identify possible cross connections and
install backflow prevention devices as
warranted; repair failed backflow
prevention devices; repair water line
breaks; disinfect and flush the aircraft
water system as soon as possible; and
resample aircraft water quality before
returning to service.
• Improperly designed aircraft water
system. The potential control measure is
to obtain FDA review and approval of
plans and specifications (Certificate of
Sanitary Construction) for new aircraft
water systems.
• Bacterial growth in aircraft water
system. The potential control measures
are to: Conduct routine total coliform
monitoring; and routinely disinfect and
flush the aircraft water system.
IV. Elements of the Proposed Aircraft
Drinking Water Rule
The following sections describe the
elements of the aircraft drinking water
rule as proposed by EPA. The proposed
rule has significant operational
advantages over the other more
prescriptive alternatives, which are
described in section V. EPA specifically
designed the proposed rule to allow air
carriers to follow the manufacturer
recommendations for disinfecting and
flushing aircraft water systems, instead
of prescribing the frequency, chemical
type and concentration to be used.
Another advantage of the proposed rule
over the approaches described in the
alternatives is that by utilizing the
manufacturer recommendations for
disinfection and flushing, the rule
requirements will automatically evolve
(another stakeholder recommendation)
with technological improvements in
aircraft water tank lining and piping
materials and as new more effective
disinfectants are developed.
EPA requests comment on all aspects
of this rule. Please note, however, that
EPA is not requesting, and will not
consider, comments on any aspect of the
TCR, surface water treatment
regulations, Public Notification Rule or
any other NPDWR other than as applied
to aircraft water systems in this
proposal. In addition to rule
requirements, EPA identifies specific
requests for comment on subject matters
pertaining to the proposed rule.
A. Sampling Requirements
1. Coliform Sampling Plan
As discussed above, the existing TCR
requires testing for total coliforms in
water systems. Under this proposal,
EPA is requiring each air carrier to
develop a coliform sampling plan
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(within six months after the final rule is
published in the Federal Register) for
each aircraft that identifies the
following: (1) Coliform sample
collection procedures, (2) sample tap
location(s) representative of the aircraft
water system, including both galley and
lavatory taps when available, (3)
frequency and number of routine
coliform samples to be collected (4)
frequency of routine disinfection and
flushing as specified in the operation
and maintenance plan, and (5)
procedures for communicating sample
results promptly so that any required
actions including repeat and follow-up
sampling, corrective action, and
notification of passengers and crew may
be conducted in a timely manner. The
development of a sampling plan will
assist the air carrier in tracking
regulatory requirements, identifying
coliform detection trends, if any exist,
and in maintaining compliance.
2. Coliform Sampling Requirements
In keeping with the current TCR, air
carriers need only determine the
presence or absence of total coliforms in
water samples collected from aircraft
water systems; a determination of total
coliform density would not be required.
EPA believes this aids in making the
sampling process more efficient and
avoids unnecessary analysis. In
addition, this proposed rule specifies
that only analytical methodologies
approved by EPA are to be used for
sampling. For routine monitoring, each
aircraft water system water sample must
be 100 mL. One sample must be taken
from a lavatory and one sample from a
galley; each must be analyzed for total
coliform. EPA believes the selection of
sample taps from both the lavatory and
the galley is necessary since tap options
throughout these types of water systems
is limited. If only one water tap is
located in the aircraft water system due
to aircraft model type and construction,
then a single tap may be used to collect
two separate 100 mL samples.
Routine coliform sampling should be
representative of the general conditions
of the aircraft water system. To ensure
that results of routine samples are not
inadvertently skewed by sampling too
soon after a disinfection event, routine
coliform samples must not be collected
within 72 hours after completing
disinfection and flushing procedures.
EPA believes that spacing routine
samples evenly across monitoring
periods will help. This is necessary in
order to capture a representative sample
from normal aircraft water system
operations. Additional, or special,
coliform sampling is always encouraged
and recommended by EPA.
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Routine coliform monitoring
frequencies are as follows:
• If the air carrier disinfects and
flushes the entire water system at least
quarterly, then coliform monitoring
must occur at least annually;
• If the air carrier disinfects and
flushes the entire water system one to
three times per year, then coliform
monitoring must occur at least
quarterly; or
• If the air carrier disinfects and
flushes the entire water system less than
once per year, then coliform monitoring
must occur at least monthly.
It should be noted that this is the first
NPDWR that requires disinfection and
flushing as a required extra barrier for
the protection of public health. EPA
understands that most of the air carrier
maintenance programs employ water
system disinfection and flushing;
however, EPA believes that making
three sampling frequency options
available to air carriers for the aircraft
water systems that they operate
provides the flexibility to meet the
evolving needs of the industry while
still providing adequate barriers of
protection.
This proposal uses calendar-based
monitoring and reporting frequencies.
This basis is also consistent with EPA’s
current methods of oversight and is
compatible with the Agency’s current
data systems. EPA is aware that the air
carrier industry typically schedules
maintenance or other activities based on
aircraft flight hours or flight days.
Scheduling activities on a calendar basis
could lead to incompatibility and
challenges in creating regular
maintenance schedules. On the other
hand, if an aircraft is not in frequent
operation, basing aircraft water system
activities on a flight time basis could
lead to an extended calendar period
before any actions are taken, which
would not be protective of public
health. EPA requests comment on
whether the proposed calendar basis
could reasonably be integrated with the
air carrier industry’s flight time basis, or
if not, how the Agency should transpose
the proposed requirements to an
equivalent standard on a flight time
basis.
B. Response to Sampling Results
1. All routine coliform samples are
negative. If all routine samples are total
coliform-negative in a monitoring
period, then the air carrier must
continue to maintain its routine
monitoring for coliform based on the
frequency required under the rule.
2. The sample yields a positive result
for total coliform. If any routine or
repeat coliform sample is total coliform-
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positive, then that total coliformpositive culture medium must be
analyzed to determine if fecal coliforms
or E. coli are present.
3. One of two routine water samples
test positive for total coliform, but
negative for E. coli or fecal coliforms. In
response to a single total coliformpositive sample result that is fecal/E.
coli negative, the air carrier must
perform at least one of the following:
• Disinfection and flushing no later
than 72 hours after the laboratory
notifies the air carrier of the positive
result. Follow-up samples must be
collected after disinfection and flushing
is performed to ensure the effectiveness
of the process. A complete set of post
disinfection and flushing follow-up
sample results (i.e., one from the
lavatories and one from the galleys)
must be total coliform-negative before
the air carrier provides water from the
aircraft water system to passengers and
crew and returns to the routine
monitoring frequency for coliform; or
• Repeat Sampling. Collect four 100
mL repeat samples within 24 hours of
being notified of the positive result.
Repeat samples must be collected and
analyzed from four taps within the
aircraft water system: the tap which
resulted in the total coliform-positive
sample, one other lavatory tap, one
other galley tap, and one other tap; if
less than four taps exist, then a total of
four 100 mL samples must be collected
and analyzed from the available taps
within the aircraft water system. If no
repeat sample is total coliform-positive,
the system returns to its routine
monitoring schedule and no further
follow-up is required.
4. Any sample test result is fecal
coliform positive or E. coli-positive.
Since fecal coliform or E. coli bacteria
indicate the potential presence of
contaminants that can cause acute
health risks, EPA believes it is necessary
to take immediate corrective action for
the protection of public health. The
aircraft water system is not a traditional
water system and the air carrier must
therefore take additional measures to
prevent any disease or illness. If any
routine or repeat sample is fecal
coliform-positive or E. coli-positive,
then the air carrier must perform all of
the following:
• Restrict public access to the aircraft
water system which includes providing
notification to passengers and crew as
soon as possible but no later than 24
hours after being notified of the positive
result.
• Conduct disinfection and flushing
prior to resumption of unrestricted
public access to the aircraft water
system or no later than 72 hours if the
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aircraft water system cannot be
physically disconnected/shut off to the
crew and passengers.
• Collect follow-up samples after
disinfection and flushing is performed
to ensure the effectiveness of the
process. A complete set of post
disinfection and flushing follow-up
sample results must be total coliformnegative before the air carrier provides
water from the aircraft water system to
passengers and crew and returns to the
routine monitoring frequency for
coliform. Follow-up sample procedures
must, at a minimum, follow routine
coliform sample locations and
procedures.
5. More than one sample resulted in
a total coliform-positive but was fecal
coliform-negative or E. coli-negative. If
more than one of any routine, repeat, or
a combination of samples is total
coliform positive and fecal coliformnegative or E. coli negative, then the air
carrier must perform all of the
following:
• Restrict public access to the aircraft
water system which includes providing
notification to passengers and crew as
soon as possible but no later than 24
hours after being notified of the positive
result.
• Conduct disinfection and flushing
prior to resumption of unrestricted
public access to the aircraft water
system, or no later than 72 hours if the
aircraft water system cannot be
physically disconnected/shut off to the
crew and passengers.
• Collect follow-up samples after
disinfection and flushing is performed
to ensure the effectiveness of the
process. A complete set of post
disinfection and flushing follow-up
sample results must be total coliformnegative before the air carrier provides
water from the aircraft water system to
passengers and crew and returns to the
routine monitoring frequency for
coliform. Follow-up sample procedures
must, at a minimum, follow routine
coliform sample locations and
procedures.
6. Post disinfection and flushing
follow-up sampling. Follow-up samples
are necessary to validate the
effectiveness of the disinfection and
flushing procedures. If one or more of
the follow-up samples in a set of followup samples is total coliform-positive
then, as a minimum, the air carrier must
disinfect and flush again, then take a
new set of follow-up samples. Both
follow-up sample results must be total
coliform-negative before the aircraft
water system provides water to
passengers and crew and the air carrier
returns to the routine monitoring
frequency for coliform.
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7. Failure to conduct routine coliform
monitoring or analysis, or boarding
water from a watering point not
approved by the FDA. If there was a
failure to collect and analyze the
required number of routine coliform
samples, or water was boarded in the
United States from a watering point not
approved by the FDA, or outside the
United States in a manner not in
accordance with the air carrier’s
procedures for ensuring the water is
safe, then the air carrier must perform
all of the following:
• Provide notification to passengers
and crew as soon as possible but in no
case later than 24 hours after discovery
of failure to collect required samples or
after being notified by EPA of failure to
collect required samples; or provide
notification to passengers and crew as
soon as possible but in no case later
than 24 hours after boarding water from
a watering point not approved by FDA.
• Conduct disinfection and flushing
within 72 hours.
• Collect follow-up samples after
disinfection and flushing is performed
to ensure the effectiveness of the
process. A complete set of post
disinfection and flushing follow-up
sample results must be total coliformnegative before the air carrier provides
water from the aircraft water system to
passengers and crew and returns to the
routine monitoring frequency for
coliform. Follow-up sample procedures
must, at a minimum, follow routine
coliform sample locations and
procedures.
This situation does not require the
same degree of restricted access because
there is no specific indication that the
water is not safe. However, to ensure
public health protection, carriers must
still warn passengers not to drink the
water, and must provide a full
explanation of the situation to the crew.
8. Failure to conduct repeat or followup monitoring or analysis, or boarding
water known to not meet NPDWRs
applicable to TNCWSs. If there was a
failure to collect and analyze the
required number of repeat or follow-up
coliform samples, or water was boarded
which is known to not meet NPDWRs,
then the air carrier must perform all of
the following:
• Restrict public access to the water
system which includes providing
notification to passengers and crew as
soon as possible but no later than 24
hours after discovery of failure to collect
required samples or after being notified
by EPA of failure to collect required
samples,
• Conduct disinfection and flushing
prior to resumption of public access to
the aircraft water system or no later than
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72 hours if the aircraft water system
cannot be physically disconnected/shut
off to the crew and passengers.
• Collect follow-up samples after
disinfection and flushing is performed
to ensure the effectiveness of the
process. A complete set of post
disinfection and flushing follow-up
sample results must be total coliformnegative before the air carrier provides
water from the aircraft water system to
passengers and crew and returns to the
routine monitoring frequency for
coliform. Follow-up sample procedures
must, at a minimum, follow routine
coliform sample locations and
procedures.
This situation, in contrast to the one
above, is one in which there is a specific
indication that the water is or may not
be safe to drink. In this case, in order
to protect public health, the same level
of restricted access and public notice is
required as for situations in which there
has been a positive coliform detection.
Restricted Access to the Water System
In any situation where there is an
affirmative indicator of actual or
potential contamination (e.g., more than
one coliform-positive sample, a single
fecal coliform- or e-coli-positive sample,
water boarded from a known
contaminated source, etc.), the carrier is
required to restrict access to the water
system as expeditiously as possible, but
in no case more than 24 hours after the
event triggering the requirement (e.g.,
positive sample result). Ideally, access
to all lavatory and galley taps, built in
coffee/tea maker, etc. should be
physically shut off, and this is required
where feasible. The carrier must also
make provisions for alternatives such as
bottled water and antiseptic alcoholbased hand gels or wipes. In cases
where it is not feasible to physically
prevent access, the carrier must provide
notice in each lavatory, galley tap, etc.,
which clearly indicates to passengers
and crew that the water is non-potable
and should not be used for drinking,
food or beverage preparation, teethbrushing, hand washing, or any other
consumptive use. Additional
information must also be provided to
the crew (see Section D. Notification
Requirements to Passengers and Crew).
Request for Comment on Sampling
Requirements and Response
1. Microbiological Indicators
The Agency’s primary interest is in
crafting a regulation for aircraft water
systems that is both implementable and
fully protective of public health. While
current methods and indicators exist to
provide meaningful characterization of
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safe drinking water, this proposal relies
on coliform bacteria as an indicator of
microbiological quality. A second
indicator commonly used to gain insight
on water quality is heterotrophic plate
count (HPC).
The Surface Water Treatment Rule
(SWTR) includes a provision which
allows a system to conduct
heterotrophic plate counts in lieu of
measuring for residual disinfectant
concentrations. Finished water with
heterotrophic bacteria concentration
less than or equal to 500 per mL is
deemed to have a detectable disinfectant
residual concentration for purposes of
determining compliance with the
SWTR. HPC sampling could be done at
the same time and place as routine
coliform monitoring, or more routinely
such as monthly as an additional check.
If heterotrophic counts are greater than
500/ml, then corrective action could be
required.
EPA requests comment on whether
HPC should be allowed, required, or not
considered as another indicator of water
quality in addition to coliform
monitoring.
2. Potential for Bacterial Growth
Water in the aircraft system which sits
for an extended period of time or is
otherwise not turned over could be at
risk for biofilm or other bacterial
growth, especially if a strong
disinfectant residual is not present.
Furthermore, total coliform as an
indicator may not identify the presence
of other organisms that may be present
in biofilm such as mycobacterium and
Legionella. Activities such as routine
disinfection and flushing, as well as the
presence of a disinfectant residual, may
help reduce risk from organisms that are
not detected via routine total coliform
monitoring.
Most aircraft water tanks are either
topped off or drained on an almost daily
basis. However, there are occasional
situations when the water may sit
stagnant. Some examples are aircraft
taken out of service for an extended
maintenance period, or cold weather
conditions that affect the ability to drain
tanks (due to environmental concerns
involving water disposal in addition to
concerns about the drained water
freezing on the tarmac). Additionally,
aircraft that experience long layovers or
overnight stays in high temperature
areas have a higher potential for rapid
growth of organisms. This proposal does
not specifically address such situations;
however, EPA requests comment on
whether the final rule should include a
provision to address extended stagnant
periods, high water temperatures or
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5. Option for Repeat Sampling
other situations that may augment
concern regarding bacterial growth.
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3. Temperature of Sample Taps
This proposal does not specify
whether samples should be taken from
hot or cold taps. Some concern exists
about sampling from hot taps since hot
water could kill microorganisms,
masking whether there is a
microbiological problem in the aircraft
system. EPA requests comment on
whether sampling should only be
limited to cold taps when they are
available. EPA also requests comment
on whether the temperature of the hot
taps should be measured to provide
some indication of whether the
temperature achieved is high enough to
alter the microbiological results.
4. Statistical Sampling
As stated earlier, each aircraft water
system is a unique system that draws
water from a potentially large number
and combination of sources and
distribution systems, which may vary
on a daily basis, or even more often.
This proposal requires corrective action
based on monitoring results for each
individual system to directly address
the risks to that system. Some
stakeholders have suggested that a
representative number of aircraft be
sampled, resulting in a statistical
sample of the air carrier fleet instead of
all aircraft being sampled. Under
current practices, the source(s) of water
for an individual aircraft are so varied
that it is difficult for a statistical sample
to provide an accurate representation of
all water being served on the aircraft. In
addition, if the Agency did have enough
evidence that allowed an extrapolation
of the statistical sample to the entire
fleet, the implication is that any positive
coliform result in the statistical sample
would trigger additional monitoring
and/or corrective action in the entire
fleet, as the statistical sample would be
used as an indicator for a systemic
problem.
EPA requests comment on the use of
statistical sampling methodologies,
specifically on what type of monitoring
scheme would allow a statistical sample
to be representative of the whole. EPA
is especially interested in getting input
on whether such methodologies, if
allowed, should only be used in
conjunction with onboard or other
supplemental treatment such as adding
a disinfectant or ultraviolet light. EPA
also requests input regarding the
support for such an option, given the
cost and logistical implications of a
positive result in the statistical sample
triggering follow-up action in the entire
fleet.
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Under this proposal, an aircraft water
system that has one total coliformpositive result under its routine
monitoring sample, but no fecal
coliform or E. coli-positive, can opt to
either go directly to corrective action
(disinfection and flushing) or perform
repeat sampling. In some cases, by the
time the air carrier is notified that the
routine sample results are total
coliform-positive it is likely that the
original water in the aircraft water
system has been changed. Under this
scenario, the repeat samples may not be
providing an accurate picture of the
water quality since it is not
characterizing the same water as the
routine sample.
EPA requests comment on whether to
disallow the option for repeat sampling
in response to the original routine total
coliform-positive if the aircraft has
boarded water since the routine sample.
6. Disinfectant Residual Monitoring
This proposal relies on a combination
of coliform bacteria monitoring with
routine disinfection and flushing of the
aircraft water system to ensure the
safety and quality of water onboard
aircraft. EPA’s SWTR requires public
water systems relying on surface water
as their water source to maintain a
detectable disinfectant residual in the
distribution system to ensure that
disinfection is maintained throughout
the water system. Since aircraft may
board water more than once per day
from a variety of sources (some of which
may be ground water that is not
disinfected), EPA is uncertain whether
monthly (or less frequent) disinfectant
residual monitoring would be adequate
to provide useful information for aircraft
water systems. Instead, EPA believes
that more frequent flushing and
disinfection of the entire aircraft water
system as a treatment technique
combined with other barriers will
ensure microbiologically safe tap water
is provided on the aircraft in lieu of the
residual disinfectant requirements
applicable to stationary public water
systems. However, EPA is also soliciting
comment on an alternative which would
add disinfectant residual monitoring to
the proposed monitoring requirements.
The microbiological safety of drinking
water supplied by public water systems
in the United States relies heavily on
disinfection of the water. This is
especially the case for systems that use
surface water as a source of water.
Although some microorganisms are
resistant to disinfection (e.g.,
Cryptosporidium), maintenance of a
disinfection residual throughout the
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distribution system helps to inactivate
many types of microorganisms in the
distribution system and controls biofilm
growth.
Not all water boarded onto aircraft at
airports is necessarily disinfected or has
disinfectant residuals. Domestic ground
water systems do not necessarily
disinfect nor have a disinfectant
residual in the distribution system. Even
if the water supplied to airports by
regulated public water systems have
disinfectant residuals at the airport taps,
the process of getting the water into
aircraft water tanks via water trucks,
carts and hoses can provide enough
mixing and aeration of the water to
volatilize the disinfectant.
As noted above, EPA believes that this
proposal adequately addresses concerns
about disinfection through the coliform
monitoring and disinfection and
flushing requirements. However, EPA
requests comment on whether it is
appropriate to require routine
monitoring for disinfectant residuals at
aircraft water systems and if so, the
frequency at which this monitoring
should occur, and what corrective
action(s) should be required if sufficient
disinfectant residuals are not detected.
7. Time Frame for Disinfection and
Flushing
The proposed rule requires
disinfection and flushing to be
conducted within 72 hours in certain
situations, for example after receiving
lab results indicating two total-coliform
positive samples or a single fecal
coliform- or e-coli positive sample
(except where the water system is
physically shut off). EPA understands
that this will generally require bringing
the aircraft to a designated maintenance
facility equipped to perform
disinfection and flushing. EPA requests
comment on whether this time frame is
appropriate.
C. Aircraft Water System Operations
and Maintenance Plan
EPA is proposing to require each air
carrier to develop and implement an
aircraft water system operations and
maintenance plan covering each type of
aircraft operated by the air carrier. An
effectively implemented plan is
essential to ensure that safe and reliable
drinking water is provided to aircraft
passengers and crew. EPA believes that
the most reliable way to ensure effective
implementation is to require that the
water system operations and
maintenance plan be included in a
Federal Aviation Administration
approved or accepted aircraft operations
and maintenance program. The FAA
requires all maintenance and
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operational procedures to be formally
documented for each aircraft. Failure by
an air carrier to perform the prescribed
program requirements may result in
forfeiture of air carrier operating
certificates and/or fines. Furthermore,
EPA is attempting to minimize
duplication of effort between the two
agencies in conducting routine oversight
and review of water system operations
and maintenance plans by requiring the
air carriers to include these plans in the
FAA approved or accepted operations
and maintenance program. However,
EPA will provide oversight of operation
and maintenance plans through periodic
compliance audits.
In order to ensure that the appropriate
multiple barriers are in place, each
aircraft water system operation and
maintenance plan (referred to as the
Plan) must include the following
components:
• Watering Point Selection
Requirement. The Plan must ensure that
all water boarded within the United
States is from an approved FDA
watering point as required under 21
CFR 1240.80, and that water boarded
outside the United States be in
accordance with procedures designed to
ensure that it is safe for human
consumption. In no event should the air
carrier knowingly serve water that
violates NPDWRs.
• Procedures for Disinfection and
Flushing of Aircraft Water System. The
Plan must include a description of
procedures for disinfection and flushing
of aircraft water systems that are
conducted in accordance with or are no
less stringent than the manufacturer
recommendations. Specifically, the
frequency of disinfection must be no
less than the minimum recommended
by the manufacturer, though it may be
more frequent. This allows for
equipment-specific designs and for
flexible implementation with the
evolution of technology. Inclusion in
the Plan of the specific disinfection
frequency, disinfecting agent used,
disinfectant concentration, disinfectant
contact time, and flushing volume or
flushing time allows for consistent
implementation of these procedures.
EPA understands that some
manufacturers do not provide
equipment disinfection and flushing
recommendations. Where a
recommended routine disinfection and
flushing frequency is not specified by
the aircraft water system manufacturer,
the aircraft water system must be
disinfected and flushed no less
frequently than quarterly.
• Procedures for Follow-up Sampling.
These must be included in the operation
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and maintenance plan to ensure
consistency in the procedures.
• Training Requirements. The Plan
must describe training protocols for all
staff involved with the operation and
maintenance provisions of this
proposed regulation and those persons
conducting or managing the
microbiological requirements of this
proposed regulation; all such staff are
required to receive training. The
NPDWRs require that each public water
system using a surface water source or
a ground water source under the direct
influence of surface water must be
operated by qualified personnel. It is
vital that persons responsible for
operating or maintaining aircraft water
systems be adequately trained to ensure
proper system operation. In order to
ensure that persons who maintain
aircraft public water systems are
competent and efficient, training of
qualified air carrier personnel specified
in the Plan must include training on at
least the following: water boarding
procedures, sample collection
procedures, disinfection and flushing
procedures, and public health and
safety reasons for the requirements of
this proposed regulation.
• Self-Inspection Procedures. The
Plan must describe the self-inspections
to be conducted and documented by the
air carrier (see Section IV.G for a
description of self-inspection
requirements under this rule).
Documentation of the results of such
inspection must be made available to
EPA during compliance audits.
• Water Boarding Procedures. The
Plan must ensure that water boarded
within the United States is from a
watering point approved by FDA, and
describe procedures for ensuring that
water boarded outside the United States
is safe for human consumption. The
Plan must also provide a description or
a discussion of how the water will be
transferred from the approved source to
the aircraft. This information will be
helpful for ground crews responsible for
maintaining the equipment supplying
the aircraft with finished water. EPA
understands and recognizes that aircraft
traveling overseas may board water from
sources that are outside the jurisdiction
of the United States. EPA is aware that
a number of air carriers already have
procedures in place to provide
assurances on the quality of water
boarded from such sources. The
proposed rule requires that all carriers
have such procedures and that they be
documented in the Plan. The Agency is
also aware that in limited
circumstances, water of unknown
quality is occasionally boarded to
operate essential systems, such as
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toilets. When instances such as these
occur, passengers and crew must be
notified, and disinfection and flushing
of the aircraft water system must occur
within 72 hours. If water known to be
in violation of NPDWRs applicable to
TNCWSs must be boarded, the rule
imposes the same requirements as for
positive coliform detects (restricted
access, public notice, and disinfection
and flushing with follow-up sampling
before unrestricted access is restored).
EPA believes this will provide the best
method of protection of public health by
minimizing the risks of exposure to
unknown contaminants. The Plan must
also include a statement as to whether
the aircraft water system can be
physically disconnected/shut off to the
crew and passengers.
• Coliform Sampling Plan. The
aircraft operation and maintenance plan
must also include the monitoring plan
for coliforms developed by the air
carrier for the specific aircraft.
Request for Comment on Operation and
Maintenance Plan Requirements
As far as EPA is aware, there are
currently no procedures or requirements
for recording information regarding
where, how much, and when water is
boarded. The boarding of water is
usually done on an as needed and as
requested basis. EPA believes that
recording such information could help
identify potential hazards from water
source(s) in the event of a total coliformpositive sample. Once the potential
source(s) are identified, further analysis
could be done to determine whether the
potential bacteriological contamination
originated from the water source(s) or
the aircraft water system. However,
given the frequency with which aircraft
currently board water, this could lead to
a large amount of data being recorded,
and therefore, EPA is not proposing to
require aircraft to record this
information. EPA requests comment on
whether the potential benefit of
recording information on water boarded
outweighs the information collection
burden. Also, EPA requests comment on
whether follow-up sampling should be
required to confirm the effectiveness of
routine disinfection and flushing, and if
so, the frequency at which this
monitoring should occur. (As previously
noted, the proposed rule already
requires follow-up sampling for
disinfection and flushing performed as
corrective action.)
D. Notification Requirements to
Passengers and Crew
A fundamental principle of SDWA is
that consumers have a right to know in
a timely manner whenever drinking
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water violations occur. EPA believes
that this includes knowing when
situations require that public access to
the aircraft water system is restricted.
The public also has a right to know
when the quality of the water cannot be
assured, for example, when water has
been boarded from a watering point not
approved by FDA or in a manner that
does not otherwise comply with the air
carrier’s procedures for ensuring safe
water outside the United States; and
about any other situation where the
Administrator, air carrier or crew
determines that notification is necessary
to protect public health.
Due to the nature of violations, or
other events that require the restriction
of water service, and the transient
nature of the population served, air
carriers must provide notification to
passengers and crew as expeditiously as
possible, but no later than 24 hours after
being informed of sample results which
trigger notification, or within 24 hours
of being informed by EPA to perform
notification, whichever occurs first.
Notification must be in a form and
manner reasonably calculated to reach
all passengers and crew while onboard
the aircraft by using one or more of the
following forms of delivery:
• Broadcast over public
announcement system on aircraft;
• Posting of the notice in conspicuous
locations throughout the area served by
the water system. These locations would
normally be the galleys and in the
lavatories of each aircraft requiring
posting;
• Hand delivery of the notice to
passengers and crew;
• Another delivery method approved
in writing by the Administrator.
The air carrier must continue to
provide notification until all follow-up
coliform samples are total coliformnegative. Each notice:
• Must be displayed in a conspicuous
way when printed or posted;
• Must not contain overly technical
language or very small print;
• Must not be formatted in a way that
defeats the purpose of the notice;
• Must not contain language that
nullifies the purpose of the notice;
• Must contain information in the
appropriate language(s) regarding the
importance of the notice reflecting a
good faith effort to reach the nonEnglish speaking population served,
including where appropriate an easilyrecognizable symbol for non-potable
water.
• When public access to the aircraft
water system is restricted the air carrier
must provide the following public
notification:
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• A prominently-displayed, clear
statement in each lavatory and galley
indicating that the water is non-potable
and should not be used for drinking,
food or beverage preparation, hand
washing, teeth brushing, or any other
consumptive use; and
• A prominent notice in the galley
directed at the crew which includes:
Æ A clear statement that the water is
non-potable and should not be used for
drinking, food or beverage preparation,
hand washing, teeth brushing, or any
other consumptive use;
Æ A description of the violation or
situation triggering the notice, including
the contaminant(s) of concern;
Æ When the violation or situation
occurred;
Æ Any potential adverse health effects
from the violation or situation;
Æ The population at risk, including
sensitive subpopulations particularly
vulnerable if exposed to the
contaminant in the drinking water;
Æ What the air carrier is doing to
correct the violation or situation; and
Æ When the air carrier expects to
return to compliance or resolve the
situation;
If access to the water system by
passengers is physically prevented
through disconnecting or shutting off
the water, or if water is supplied only
to lavatory toilets, and not to any
lavatory taps, then only the notice to the
crew is required. This exception only
applies when there is no possibility of
the passengers accessing the water
system for consumptive use.
Notice when water has been boarded
from a watering point not approved by
FDA or when required routine
monitoring or disinfection and flushing
was not conducted must include:
• A prominently-displayed, clear
statement in each lavatory indicating
that the water is non-potable and should
not be used for drinking, food or
beverage preparation, or teeth brushing
(in this situation, hand washing need
not be restricted, given that there is no
affirmative indication of a problem with
the water and hand washing generally
reduces microbial risk); and
• A prominent notice in the galley
directed at the crew which includes:
Æ A clear statement that the water is
non-potable and should not be used for
drinking, food or beverage preparation,
or teeth brushing;
Æ An indication that water was
boarded from a watering point that has
not been approved by FDA, or when
required monitoring or required
disinfection and flushing was not
conducted and it is not known whether
the water is contaminated;
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Æ When and where the water was
boarded from a watering point that has
not been approved by FDA, or when the
specific monitoring or disinfection and
flushing requirement was not met;
Æ Any potential adverse health effects
from exposure to waterborne pathogens
that might be in the water;
Æ The population at risk, including
sensitive subpopulations particularly
vulnerable if exposed to the
contaminant in the drinking water; and
Æ A statement indicating when the
system will be disinfected and flushed
and returned to service if known;
EPA is proposing the following
standard health effects language for air
carriers to use in creating public notices
to the crew:
• Health effects language to be used
when notice was triggered by an event
other than a coliform-positive sample,
including where water was boarded
from a watering point not approved by
FDA:
Because [required monitoring was not
conducted], [required disinfection and
flushing was not conducted], [water was
boarded from a watering point not approved
by FDA], or [other appropriate explanation],
we cannot be sure of the quality of the
drinking water at this time. However,
drinking water contaminated with human
pathogens can cause short-term health
effects, such as diarrhea, cramps, nausea,
headaches, or other symptoms. They may
pose a special health risk for infants, young
children, some of the elderly, and people
with severely compromised immune systems.
This water may be used for hand washing,
but not for drinking, food or beverage
preparation, or teeth brushing.
• Health effects language to be used
when more than one routine sample is
total coliform-positive and fecal
coliform-negative and E. coli-negative,
or a repeat sample is total coliformpositive and fecal coliform-negative or
E. coli-negative must include the
following:
Coliform are bacteria that are naturally
present in the environment and are used as
an indicator that other, potentially harmful,
bacteria may be present. Coliforms were
found in [insert number of samples detected]
samples collected and this is a warning of
potential problems. If human pathogens are
present, they can cause short-term health
effects, such as diarrhea, cramps, nausea,
headaches, or other symptoms. They may
pose a special health risk for infants, young
children, some of the elderly, and people
with severely compromised immune systems.
• Health effects language to be used
when any routine or repeat sample is
fecal coliform positive or E. coli
positive:
Fecal coliform and E. coli are bacteria
whose presence indicates that the water may
be contaminated with human or animal
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wastes. Microbes in these wastes can cause
short-term health effects, such as diarrhea,
cramps, nausea, headaches, or other
symptoms. They may pose a special health
risk for infants, young children, some of the
elderly, and people with severely
compromised immune systems.
All notification required to be posted
or announced must continue until all
follow-up coliform samples are total
coliform-negative.
rwilkins on PROD1PC63 with PROPOSALS3
E. Reporting Requirements
As for all public water systems, EPA
believes it is essential for accountability
and regulatory oversight that certain
information be reported to EPA by the
air carrier. At the same time, EPA
believes that the type and amount of
information should be carefully tailored
to the purpose of reporting it, to avoid
duplication, wasted resources, and
unnecessary burdens for either industry
or EPA. Therefore, the reporting
requirements of the proposed rule are
designed to capture only information
that will be used for compliance and
accountability.
For existing aircraft water systems,
the air carrier must report to EPA the
frequency for routine coliform sampling
identified in the coliform sampling plan
required for each aircraft public water
system and that the air carrier has
updated its operations and maintenance
plan by six months after the final rule
is published. For new aircraft water
systems, the air carrier must report to
EPA the frequency for routine coliform
sampling as identified in the coliform
sampling plan for each aircraft and that
the air carrier has an approved
operations and maintenance plan within
the first calendar quarter of initial
operation of the aircraft.
In addition, the air carrier must report
the following information through
electronic means as approved or
established by EPA:
• The air carrier must report its
complete inventory of aircraft that are
PWSs to EPA no later than six months
after publication of the final rule in the
Federal Register. Inventory information
includes: (1) The unique aircraft
identifier number, (2) the status of the
aircraft water system as active or
inactive, (3) any water system treatment
installed on the aircraft, and (4) whether
access to the water system can be
physically shut off or disconnected to
passengers and crew.
• Changes in aircraft inventory no
later than 10 days following the
calendar month in which the change
occurred. Changes include new aircraft,
aircraft that are removed from service,
and a change to any of the data items
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previously listed in (1) through (4) of
this section.
• All sampling results no later than
10 calendar days following the
monitoring period in which the
sampling occurred.
• All events requiring notification of
passengers and crew and non-routine
disinfection and flushing must be
reported within 10 days of the air carrier
being informed of sample results.
Because the corrective action
requirements for aircraft water systems
are contained directly in the rule (e.g.,
restricted access, disinfection and
flushing, follow-up sampling), and do
not require consultation with the
primacy agency, EPA believes it is
appropriate to allow a slightly longer
time frame for reporting than would be
required for land-based public water
systems (i.e., generally 24 hours).
• Evidence of self-inspection must be
provided to EPA within 90 days of
completion, including an indication that
any deficiencies identified during the
self-inspections have been addressed.
Air carriers must also report within 90
days that deficiencies identified during
a compliance audit have been
addressed. If any deficiency identified
during either self-inspection or a
compliance audit has not been
addressed within 90 days, the carrier
must report details of the deficiency,
why it has not yet been addressed, and
a schedule for addressing it as
expeditiously as possible.
Failure to provide this information
within a timely manner will result in
noncompliance with the rule and may
result in an enforcement action, which
may include the assessment of
penalties.
The air carrier must report to EPA
within 10 calendar days the failure to
comply with the monitoring or
disinfection and flushing requirements
of this proposed regulation.
Reporting requirements begin six
months after the final rule is published.
As the primacy agency, EPA has to
oversee reporting by air carriers. To
facilitate collection and analysis of
aircraft water system data, EPA is
developing an internet based electronic
data collection and management system.
This approach is similar to that used
under the EPA SDWIS/STATE (Safe
Drinking Water Information System/
State version) reporting program.
Inventory and analytical results for
microbiological testing will be reported
directly to this database using web
forms and software that can be
downloaded free of charge. The data
system will perform logic checks on
data entered and calculate final results
for accountability and regulatory
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19333
oversight. This is intended to reduce the
reporting errors and limit the time
involved in investigating, checking, and
correcting errors at all levels. Air
carriers should instruct their
laboratories to either manually enter
sample analysis results into an EPA
managed web-based data system, or to
electronically upload data files from
their laboratory information
management systems (LIMS) to a webbased data file submission program.
These data files must be in a format
prescribed by EPA. If an air carrier
believes that a result was entered into
the data system erroneously, the air
carrier may notify the laboratory to
rectify the entry. The laboratory must be
a state- or EPA-certified laboratory that
adheres to the approved quality control
procedures for checking analytical data
for completeness and correctness. In
addition, if an air carrier believes that a
result is incorrect, they may submit the
result as a contested result and petition
EPA to invalidate the sample. If an air
carrier contests a sample result, they
must submit a rationale to EPA,
including a supporting statement from
the laboratory, providing a justification.
The invalidation of a total coliform
sample result can only be made by EPA
in accordance with 40 CFR
141.21(c)(1)(i), (ii), or (iii) or by the
state- or EPA-certified laboratory in
accordance with 40 CFR 141.21 (c)(2).
Also, if an air carrier determines that its
laboratory does not have the capability
to report data electronically, they can
submit a request to EPA to use an
alternate reporting format.
F. Recordkeeping Requirements
EPA is proposing that air carriers
retain certain information for the aircraft
that they own or operate. Records to be
retained include the following:
• Records of bacteriological analyses
must be kept for at least 5 years and
must include the following information:
date, time and place of sampling, and
the name of the person who collected
the sample; identification of the sample
as a routine, repeat, follow-up or other
special purpose sample; date of the
analysis; laboratory and person
responsible for performing the analysis;
the analytical technique/method used;
and the results of the analysis.
• Records of any disinfection and
flushing must be kept at least 5 years.
• Records of a self inspection must be
kept for at least 10 years.
• Sampling plans must be maintained
by the air carrier and made available for
review by EPA upon request, including
during compliance audits.
• Aircraft water system operation and
maintenance plans must be maintained
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rwilkins on PROD1PC63 with PROPOSALS3
by the air carrier and made available for
review by EPA in accordance with FAA
requirements; such plans must be
available for review by EPA upon
request, including during compliance
audits.
• Records of notices to passengers
and crew issued as required by this
proposal must be kept for at least 3
years after issuance.
G. Audit and Self-Inspection
Requirements
SDWA sections 1413 and 1451
authorize EPA to approve States and
Indian Tribes to be the primary
implementation authority for federal
drinking water standards; this is known
as ‘‘primacy.’’ However, EPA
regulations provide that State/Tribal
primacy programs do not include public
water systems on ICCs, such as aircraft
(40 CFR 142.3). As a result, EPA
remains responsible for implementation,
including enforcement, of the ADWR.
EPA may conduct routine compliance
audits as deemed necessary in providing
regulatory oversight to ensure proper
implementation of the requirements in
the proposed rule. Compliance audits
may include, but are not limited to, the
following: bacteriological sampling of
aircraft drinking water, reviews and
audits of records as they pertain to
water system operations and
maintenance such as log entries,
disinfection and flushing procedures,
and sampling results; and observation of
procedures involving the handling of
finished water, watering point selection,
boarding of water, operation,
disinfection and flushing, and general
maintenance of aircraft water systems.
In addition, instead of the sanitary
survey required for other public water
systems every 5 years, EPA is proposing
that self-inspections be conducted by
the air carrier for each aircraft water
system no less frequently than once
every 5 calendar years. The air carrier
must address deficiencies found as a
result of routine compliance audits or
self-inspections within 90 days of
identification of the deficiency or where
such deficiency is identified during
extended or heavy maintenance before
the aircraft is put back into service. EPA
notes that the air carrier industry
conducts routine inspections for flight
safety before each flight. The safety of
all flight participants, pilot, flight
attendants and passengers, is considered
prior to take-off. EPA expects the same
level of attention to be exhibited when
air carriers conduct self-inspections of
their aircraft public water systems.
When conducting inspections of their
water systems, air carriers should
examine, but are not limited to, the
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storage tank, distribution system,
supplemental treatment, fixtures,
valves, and backflow prevention
devices.
H. Supplemental Treatment
Onboard treatment units are not
required for use with finished water but
can provide a desirable additional
barrier of protection. If used, they must
be acceptable to FDA, must meet NSF
International / American National
Standards Institute (ANSI) Standards,
and must be installed, operated, and
maintained in accordance with the
manufacturer’s plans and specifications
and approved or accepted by FAA (14
CFR Part 43, 14 CFR Part 91, 14 CFR
Part 121). Water treatment and
production equipment must produce
water that meets the standards
prescribed in 40 CFR Part 141.
Request for Comment on Supplemental
Treatment
A supplemental treatment protection
barrier for water boarded onto aircraft
water systems is not required by the
proposed rule. However, the proposed
rule includes other multiple barriers
that ensure the protection of public
health. These protection barriers
include requirements that boarded
water must meet all NPDWRs applicable
to TNCWSs, must be obtained from an
FDA-approved watering point, and that
personnel involved in the water transfer
process must receive adequate training
on appropriate procedures to maintain
water quality and prevent
contamination. Furthermore, the
proposed rule requires disinfection and
flushing of aircraft water systems on a
routine basis to ensure tanks and piping
on each aircraft are clean. As proposed,
the interval for routine disinfection and
flushing of the aircraft water system
may vary from four times per year
(quarterly) to less than once per year
based on manufacturer
recommendations. Also, the proposed
rule establishes compliance monitoring
schedules for each aircraft water system
at frequencies that increase or decrease
in relation to the disinfection and
flushing intervals. For example, if an
aircraft water system is disinfected and
flushed once per quarter, the air carrier
is required to sample for microbiological
presence annually. On the other hand,
if an aircraft water system is disinfected
and flushed less than once per year, the
air carrier must sample monthly for
microbiological presence. If compliance
monitoring indicates a potential
contamination problem, the proposed
rule requires specific actions (e.g.,
sampling, disinfection and flushing, and
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notifying the passengers and crew) to be
taken to address the problem.
While these barriers are specifically
tailored to reduce risk, the possibility
exists that microbiological
contamination of the aircraft water
system may occur. Traditional water
systems often rely on maintenance of a
distribution system disinfectant residual
to help inactivate certain
microorganisms and control biofilm
growth. In situations where the
disinfectant added at the water
treatment plant is insufficient to
maintain a residual throughout the
distribution system, supplemental
disinfection within the distribution
system may be used to maintain a
detectable disinfectant residual. For
example, traditional systems frequently
supplement or ‘‘boost’’ the disinfectant
residual level by injecting a chlorine
solution into the water in specific areas
of a distribution system. However, the
distribution system in a traditional
water system may be very extensive
compared to the very limited
distribution system onboard an aircraft.
Another critical consideration is that
some of the chemical properties of
chlorine (e.g., corrosive, volatile, toxic)
may be problematic if stored in quantity
for supplemental treatment purposes
onboard aircraft.
Another option for providing a barrier
against microbiological contamination is
the use of ultraviolet light (UV) to
provide a means of physical
disinfection. Interest in using UV light
to disinfect drinking water is growing
among public water systems due to its
ability to inactivate pathogenic
microorganisms without forming
regulated disinfection byproducts. UV
light has also proven effective against
some pathogens, such as
Cryptosporidium, which are resistant to
commonly used disinfectants like
chlorine. EPA is aware that at least one
manufacturer provides UV disinfection
systems certified by the FAA to be
retrofitted onto passenger aircraft. EPA
is interested in obtaining information
about this or other treatment system
specifications with respect to cost,
reliability, operation and maintenance,
etc.
EPA requests comment on whether to
require supplemental disinfection of
water boarded onto aircraft and whether
to require monitoring for disinfectant
residuals either in addition to or in lieu
of supplemental disinfection. EPA is
interested in obtaining any other
information that should be considered
in evaluating this alternative, or if there
are other alternatives that would be
effective in providing additional safety
of aircraft drinking water from
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microbiological contamination. In
addition, EPA is requesting comment on
the feasibility of using other types of
supplemental disinfection, such as UV
treatment onboard aircraft, including
providing incentives such as reduced
routine monitoring or routine
disinfection and flushing if an air carrier
provides supplemental treatment.
rwilkins on PROD1PC63 with PROPOSALS3
I. Violations
For purposes of this proposed rule,
the following situations will constitute
a violation where an air carrier will be
required to provide notification to
passengers and crew on the aircraft that
triggered the violation:
• Failure to disinfect and flush;
• Failure to monitor for total coliform
and where required for fecal coliform/E.
coli;
• Failure to take required corrective
action;
• Has one or more fecal coliform
positive or E. coli positive sample in
any monitoring period (routine and
repeat samples are used in this
determination).
In addition, the following situations
will constitute a violation, but does not
trigger additional public notification
requirements:
• Failure to comply with the
proposed rule’s public notice
requirements;
• Failure to comply with reporting
and recordkeeping requirements;
• Failure to conduct a self-inspection
or address deficiencies;
• Failure to develop a coliform
sampling plan; and develop and include
an aircraft water system operations and
maintenance plan in an FAA approved
or accepted operations and maintenance
program,
J. Compliance Date
EPA is proposing that the date for air
carriers to comply with the
requirements of this rule be six months
from the date of promulgation for
several reporting and planning
requirements and one year from the date
of promulgation for the rest of the rule
requirements. Section 1412(b)(10) of
SDWA directs EPA to establish a date
for compliance that is three years after
publication unless EPA determines that
a shorter compliance date is practicable.
EPA believes that the six months and
one year timeframes are practicable for
several reasons. First, this rule will be
directly implemented by EPA so it will
not be necessary to allow two years for
States to obtain primary enforcement
authority to implement the rule.
Second, since air carriers were out of
compliance with the existing NPDWRs,
most have been placed under
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18:11 Apr 08, 2008
Jkt 214001
Administrative Orders on Consent,
which have requirements similar to
those of the proposed ADWR.
Complying with the proposed
requirements will not require significant
changes in practice from the existing
administrative orders. In addition, an
earlier compliance date will allow the
air carriers to be taken off of the AOCs
and be brought into compliance with
the NPDWRs sooner. EPA also believes
it is practicable for air carriers to
implement and report within six
months of promulgation of the rule the
following: (1) The development of a
coliform sampling plan and the selected
frequency of coliform sampling, (2) the
development of operations and
maintenance plans in accordance with
the rule and (3) fleet inventory data.
None of these three rule provisions
require extensive planning or
expenditures.
EPA is requesting comment on the
compliance dates of the proposed
ADWR.
V. Cost Analysis
This section summarizes EPA’s
estimates of the cost of this proposal, as
well as the estimated costs of other
regulatory alternatives that were
considered but rejected.
A. Summary of Regulatory Alternatives
Considered
In developing this proposed rule, EPA
evaluated four options: The current
regulations and three alternatives, one
of which is the proposed rule. For each
option, EPA estimated annualized costs
and relative risks, and characterized
anticipated benefits. The alternatives
considered include the following:
(1) Existing Drinking Water
Regulations.
(2) Regulatory Requirements Similar
to the Air Carrier Administrative Orders
on Consent (AOCs).
(3) Water Supply Guidance 29.
(4) Proposed Rule.
The following briefly summarizes the
three alternatives plus the proposed
rule. For the purposes of each
alternative, aircraft are assumed to be
boarding finished water. Finished water
is defined in 40 CFR 141.2 as water that
is introduced into the distribution
system of a PWS and is intended for
distribution and consumption without
further treatment, except treatment
necessary to maintain water quality in
the distribution system. Prior to
boarding the water, compliance with
FDA and FAA requirements is expected
to ensure that water from the supplier
meets NPDWR standards and that the
equipment used in transferring this
water to the aircraft is maintained and
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19335
operated so as to preserve that level of
water quality.
Alternative 1—Existing Drinking Water
Regulations
Alternative 1 assumes that all carriers
with aircraft water systems subject to
SDWA continue to be subject to the
current requirements under the
applicable NPDWRs for each aircraft
water system. Alternative 1 includes the
following regulatory components for
compliance with existing NPDWRs:
• Monthly routine monitoring (single
sample) for total coliform bacteria (TC);
• Repeat monitoring for TC after an
initial TC positive sample;
• Analysis of TC positive culture
media for the presence of fecal coliforms
or E. coli);
• Additional routine TC samples in
the month following a positive routine
sample;
• Sanitary surveys conducted every 5
years: Includes an evaluation of the
applicable components of a water
system (source; treatment; distribution
system; finished water storage; pumps,
pump facilities, and controls;
monitoring, reporting, and data
verification; system management and
operation; and air carrier compliance
with state requirements);
• Monthly disinfection residual
monitoring; and
• Public notification for violations.
Alternative 2—Regulatory
Requirements Similar to the Air Carrier
Administrative Orders on Consent
Alternative 2 describes requirements
similar to those negotiated under the
Administrative Orders on Consent
(AOCs), and with which many air
carriers must currently comply as an
interim measure until the ADWR is
finalized. Alternative 2 includes the
following regulatory components:
• All maintenance personnel
responsible for the operations and
maintenance of aircraft water systems
receive training. The training would be
implemented by the air carrier
responsible for the aircraft.
• Aircraft operations and
maintenance plans and monitoring
plans must be updated to reflect new
schedules, procedures, and activities.
• Air carriers must monitor for total
coliforms and disinfectant residual.
• If an aircraft water system tests
positive for total coliforms, the TC
positive culture medium must be
analyzed for fecal coliform or E. coli.
• If an aircraft water system tests
positive for fecal coliform or E. coli, or
if it tests positive for total coliform in
any sample, the air carrier must notify
EPA within 24 hours and must conduct
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corrective action disinfection and
flushing procedures, including followup sampling, and must implement
public notification activities.
• Copies of operations and
maintenance plans, monitoring plans,
and monitoring data must be
maintained by the air carrier.
• Approximately 25 percent of the
aircraft fleet must be monitored for
coliforms and disinfectant residual
quarterly, so that all aircraft are sampled
at least annually.
• Routine disinfection and flushing
must be performed at least quarterly.
• A self-certification that affirms that
the aircraft water system was
disinfected and flushed according to the
operations and maintenance plan must
be submitted to EPA each quarter.
• Air carriers must report monitoring
results quarterly (within 10 business
days of the end of a quarter of
monitoring).
Alternative 3—Water Supply Guidance
29
Alternative 3 describes the
requirements included in Water Supply
Guidance 29, which described an
alternative to the NPDWRs and was in
effect from October 1986 until it was
suspended by EPA in September 2003.
WSG 29 described the implementation
of an operations and maintenance
program that included disinfection and
flushing the aircraft in lieu of
monitoring for those contaminants that
pose an acute health threat based on
short-term consumption by passengers
and crew. These include turbidity,
coliform, and nitrate. It is notable that
WSG 29 was written prior to
promulgation of the Total Coliform
Rule, the Surface Water Treatment Rule,
or the Phase II Chemical contaminant
rule (which included revised
requirements for nitrate). Alternative 3
includes the following components:
• Air carriers would comply with
either the monitoring and reporting
requirements or with their approved
operations and maintenance plans.
• Minimum monitoring requirements
would include daily turbidity
monitoring, quarterly coliform
monitoring, and annual nitrate/nitrite
monitoring.
• Corrective action of disinfection
and flushing the aircraft’s water system
would be required following a TC
positive sample.
• Operations and maintenance
requirements include quarterly
disinfection and flushing of onboard
water systems.
Proposed Rule
The proposed rule represents a hybrid
approach that combines what EPA
believes are the most practical elements
of the other alternatives with flexibility
for the air carriers in how they
implement the regulatory requirements.
This proposed approach allows
compliance with regulatory components
that are most tailored to the unique
circumstances of aircraft drinking water
systems and the operational needs of
each air carrier. Key components of the
proposal include the following:
• Routine disinfection and flushing of
the aircraft water system based on
manufacturer recommendations.
• Routine coliform monitoring using
one of three monitoring frequency
options determined by the frequency of
disinfection and flushing of the aircraft
water system.
• Two routine coliform samples
collected at the frequency chosen, one
sample from a lavatory and one sample
from a galley. If one routine sample is
total coliform-positive the air carrier
chooses to either perform repeat
sampling (collecting 4 samples) or
conduct corrective action, which
includes disinfection and flushing of the
water system and follow-up monitoring.
• In the event of a fecal coliform/E.
coli-positive sample or more than one
total coliform-positive sample,
corrective action disinfection and
flushing is performed, access to water is
restricted, and public notice is to be
posted and/or announced until the
water system is disinfected and flushed
and all follow-up samples are total
coliform-negative.
• Disinfectant residual monitoring is
not required but is recommended as a
means of indicating water quality and
prompting voluntary corrective
measures such as flushing and refilling
the tank with water containing a
residual.
• Specific training requirements of
maintenance personnel are included in
the aircraft operations and maintenance
plan.
• Specific requirements for
disinfection and flushing procedures are
included in the aircraft operations and
maintenance plans.
• Monitoring results and compliance
status are reported to EPA.
• Water system operations and
maintenance plans are incorporated into
FAA approved/accepted aircraft
operations and maintenance programs.
• EPA performs compliance audits as
needed.
• Carriers perform self-inspections of
the each aircraft water system every 5
years and certify completion of the selfinspections.
B. National Cost Estimates
EPA estimates that the annualized
cost to the air carriers of carrying out the
activities required in this proposed rule
is $7.86 million at a 3 percent discount
rate and $7.96 million at a 7 percent
discount rate. EPA compares the costs of
the regulatory alternatives in the next
section. Also, Table V–2 presents total
annualized present value costs by
alternative. Because EPA is the primacy
agency for aircraft water systems, EPA’s
costs to implement the proposed
requirements have also been estimated.
Table V–1 presents the total annualized
costs to air carriers (airlines) and EPA
for the proposed ADWR preferred
alternative at 3 and 7 percent discount
rates.
TABLE V–1.—TOTAL ANNUALIZED PRESENT VALUE COSTS FOR THE PROPOSED ADWR
[$Millions, 2006$]
Air carriers
Agency
Total
Air carriers
Agency
rwilkins on PROD1PC63 with PROPOSALS3
3%
Implementation .............................
Annual Administration ..................
Sampling Plan ..............................
O&M Plan .....................................
Coliform Monitoring ......................
Routine Disinfection and Flushing
Corrective Action Disinfection and
Flushing ....................................
Compliance Audit .........................
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$0.002
..........................
0.002
0.01
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2.37
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0.14
0.01
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$0.01
0.25
0.001
0.000
0.04
..........................
$0.01
0.25
0.003
0.01
5.36
2.37
..........................
0.01
0.14
0.02
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Total
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$0.003
..........................
0.003
0.02
5.39
2.40
0.14
0.01
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$0.01
0.25
0.001
0.000
0.04
..........................
$0.01
0.25
0.004
0.02
5.43
2.40
..........................
0.01
0.14
0.02
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TABLE V–1.—TOTAL ANNUALIZED PRESENT VALUE COSTS FOR THE PROPOSED ADWR—Continued
[$Millions, 2006$]
Air carriers
Agency
Total
Air carriers
Agency
3%
Total ......................................
7.86
C. Comparison of Cost of Regulatory
Alternatives
Table V–2 provides a summary of the
annualized present value costs for each
regulatory alternative considered during
the regulatory development process at 3
and 7 percent discount rates. EPA used
the same process for developing cost
estimates for all regulatory alternatives
as was done for the proposed option.
Unit costs were multiplied by the
number of air carriers or aircraft
performing various components of each
alternative, and results were summed
for all components.
Relative to the regulatory
requirements currently in the Code of
Federal Regulations (Alternative 1), the
proposed rule (Alternative 4) represents
a significant reduction in cost. The
estimated total annualized present value
cost of $8.16–$8.27 million for the
proposed rule is only about one-fourth
of the estimated cost of Alternative 1, as
a result of tailoring the current
regulations to the specific operational
characteristics of aircraft drinking water
systems. Relative to the Administrative
Orders on Consent (Alternative 2),
which is the current practice of aircraft
water systems, the proposed rule
represents a slight increase. However,
the proposed rule offers operational
Total
7%
0.30
8.16
7.96
advantages over the other alternatives
including the slightly less costly, but
more prescriptive, Alternative 2. EPA
specifically designed the proposed rule
to allow air carriers to follow the
manufacturer recommendations for
disinfecting and flushing aircraft water
systems, instead of prescribing the
frequency, chemical type and
concentration to be used, which is the
case in Alternative 2. The less
prescriptive approach of the proposed
rule addresses valuable stakeholder
input, which recommended that EPA
utilize the technical recommendations
of the water system manufacturer rather
than prescribe disinfection and flushing
procedures that may not be appropriate
for all aircraft water systems and may
even be detrimental. Another advantage
of the proposed rule over the approach
used in Alternative 2 is that by utilizing
the manufacturer recommendations for
disinfection and flushing, the rule
requirements will automatically evolve
(another stakeholder recommendation)
with technological improvements in
aircraft water tank lining and piping
materials and as new more effective
disinfectants are developed.
In addition to operational advantages,
the less prescriptive approach taken by
the proposed rule may translate into a
lower cost than is reflected in Table V–
0.31
8.27
2. First, the proposed rule allows air
carriers to perform the disinfection and
flushing of aircraft water systems on
schedules that are based on (or more
frequent than) the manufacturer
recommended maintenance frequencies
and are included in their FAA-approved
or accepted operation and maintenance
programs. To provide this flexibility,
EPA designed the monitoring schedules
for aircraft water systems around the
manufacturer recommended
disinfection and flushing frequencies.
EPA believes this approach is less
disruptive to airline operations, which
reduces the overall cost of the proposed
rule by some unquantified amount.
Under the proposed rule, the more
frequently the aircraft water system is
cleaned, the less monitoring is required.
In estimating the cost of the proposed
rule in Table V–2, EPA assumed for
simplicity that 45% of the aircraft water
systems would follow a schedule of
quarterly disinfection and flushing and
annual fleet monitoring, which is the
same schedule as prescribed in
Alternative 2. If more than 45% of the
aircraft water systems covered by the
proposed rule choose this frequency,
then any difference in cost between the
proposed rule and Alternative 2 will be
reduced or possibly eliminated.
TABLE V—2.—TOTAL ANNUALIZED PRESENT VALUE COSTS, BY ALTERNATIVE
[$Millions, 2006$]
Alt 1
Alt 2
Alt 3
Alt 4
Alt 1
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3%
Alt 2
Alt 3
Alt 4
7%
Implementation .................................................................
Annual Administration ......................................................
Monitoring Plan ................................................................
O&M Plan .........................................................................
Coliform Monitoring ..........................................................
Disinfectant Residual Monitoring .....................................
Routine Disinfection and Flushing ...................................
Corrective Action Disinfection and Flushing ....................
Sanitary Survey/Compliance Audit ..................................
Turbidity Monitoring .........................................................
0.01
0.25
0.003
..............
26.53
3.65
..............
..............
0.72
..............
0.01
0.25
0.003
..............
1.68
0.75
4.98
0.05
..............
..............
0.01
0.25
0.001
0.01
2.29
..............
3.39
0.05
..............
15.01
0.01
0.25
0.003
0.01
5.36
..............
2.37
0.14
0.02
..............
0.01
0.25
0.004
..............
26.85
3.69
..............
..............
0.73
..............
0.01
0.25
0.004
..............
1.70
0.76
5.04
0.05
..............
..............
0.01
0.25
0.002
0.01
2.31
..............
3.43
0.05
..............
15.19
0.01
0.25
0.004
0.02
5.43
..............
2.40
0.14
0.02
..............
Total ..........................................................................
31.16
7.72
21.00
8.16
31.54
7.82
21.26
8.27
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D. Estimated Impacts of Proposed Rule
to Air Carrier Passengers
EPA assumes that air carriers will
pass on some or all of the costs of a new
regulation to their passengers in the
form of ticket price increases. EPA
estimates that 708.4 million passengers
travel each year on aircraft that are
affected by the ADWR. The cost passed
on to passengers can be roughly
estimated by dividing the air carriers’
annualized costs incurred by the
number of passengers traveling each
year. Based on this approximation, EPA
estimates that passengers could face a
relatively negligible increase of about
one cent per ticket.
E. Non-quantified Costs and
Uncertainties
1. Non-quantified Costs
Although EPA has estimated the
majority of costs of the proposed
ADWR, there are some costs that EPA
was not able to quantify, such as:
• Air carrier costs for service
interruptions due to unanticipated
aircraft maintenance needs;
• Passenger costs due to flight
cancellations or delays related to aircraft
maintenance;
• Air carrier costs to provide bottled
water due to lack of onboard tap water
during a coliform violation;
• Air carrier customer service
response to customer concerns
following notification to passengers and
crew.
EPA believes that the most significant
non-quantified cost is the cost
associated with the disruption to air
carriers’ flight schedules caused by
monitoring and maintenance
requirements. Table V–3 presents the
estimated number of monitoring and
disinfection and flushing events per
year for all regulatory alternatives. Some
fraction of these could cause disruption
to air carrier schedules.
TABLE V–3.—SUMMARY OF MONITORING AND DISINFECTION/FLUSHING EVENTS FOR ALL ALTERNATIVES
Monitoring
Disinfection and Flushing
Routing
monitoring
coliform
sampling
events/year
rwilkins on PROD1PC63 with PROPOSALS3
Alt
Alt
Alt
Alt
1
2
3
4
Disinfectant
residual
monitoring
sampling
events/year
Total number of sampling
events/year
Routine disinfection
and flushing
events/year
Corrective
action disinfection
and flushing
events/year
Total number of disinfection
and flushing
events/year
A
Rule Alternative
B
C=A+B
D
E
F=D+E
....................
29,308
29,308
20,516
....................
454
454
1,175
....................
29,762
29,762
21,691
..................................................................................
..................................................................................
..................................................................................
..................................................................................
Of the alternatives that require
disinfection and flushing, the proposed
rule has the least estimated number of
disinfection and flushing events/year
(21,691), and Alternative 2 and 3 have
fewer estimated monitoring events than
the proposed rule. EPA does not have
sufficient data to quantify the number of
events that would actually cause
disruption to air carriers and the costs
of such disruptions. However, EPA
believes that the number of actual
disruptions would be lower for the
proposed rule compared to Alternatives
1–3 due to the flexibility offered to air
carriers in choosing monitoring
frequencies under the proposal. EPA
assumes that the increased flexibility of
the proposal would allow air carriers to
schedule routine monitoring and
disinfection and flushing to coincide
with existing routine maintenance
checks. This would in turn decrease
potential disruption to air carrier flight
schedules and thus decrease air carrier
burden and cost for complying with the
proposed ADWR monitoring and
disinfection and flushing requirements.
Therefore, if disruption costs were
included in the quantified costs of the
rule, the costs for the proposed rule
option would likely decrease with
respect to the other Alternatives.
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46,248
7,708
7,708
26,593
46,248
7,708
....................
....................
92,496
15,416
7,708
26,593
2. Uncertainties in Cost Estimates
Many factors contribute to uncertainty
in the national cost estimates including:
• Percent of aircraft that will be
subject to each coliform monitoring
option.
• Expected results from total coliform
monitoring.
• Estimated time for air carrier
management to read, understand, and
decide how to best comply with the
ADWR; and develop training, train staff,
and oversee compliance.
For simplicity, EPA assumed for this
analysis that all air carriers subject to
the proposed ADWR would spend equal
management time on ADWR
requirements, regardless of fleet size or
aircraft type. Assuming equal burden for
all air carriers to comply with these
proposed rule management and
oversight requirements could result in
an over- or under-estimate of the costs
presented.
In developing costs for air carriers to
comply with the proposed selfinspection requirements, EPA assumed
that with the exception of reporting and
recordkeeping burden, no additional
costs for self-inspections are incurred by
air carriers. Labor burden for selfinspections, which involve a thorough
review and inspection of an aircraft
water system, is already captured under
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current FAA requirements and therefore
is not included in the cost estimate for
this rule. This assumption potentially
underestimates air carrier labor burden
for self-inspections where deficiencies
noted during self-inspections are not
addressed during routine aircraft
maintenance procedures.
VI. Relative Risk Analysis and Benefits
This section summarizes the risk (and
benefit) tradeoffs between compliance
with existing NPDWRs (baseline
conditions) and the alternatives
considered during the regulatory
development process. Evaluations
include a qualitative analysis that
compares the risks for each regulatory
alternative as compared to baseline
conditions. The qualitative analysis uses
the collective professional judgment of
an EPA team that included scientists
and engineers and representatives of
FDA and FAA, not quantitative data, to
establish a relative risk rating for each
regulatory component. Potential benefits
of compliance with the regulatory
alternatives are also discussed. It is
important to note that these analyses are
only for comparing the alternatives
relative to one another. EPA did not
conduct a risk assessment, and the
analyses are not intended to provide any
insights into either the nature or the
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magnitude of possible public health
risks that are associated with the
consumption of drinking water on
aircraft, or with the expected reductions
in those public health risks anticipated
from implementation of this rule.
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A. Relative Risks—Qualitative Analysis
The goal of the ADWR is to tailor
existing NPDWRs to the unique
characteristics of aircraft water systems.
Because the requisite data on
contaminant occurrence (both frequency
and concentration), health effects, and
water consumption are not available to
support a quantitative analysis, EPA
estimated the relative risks of the
regulatory options considered for the
proposed ADWR. The existing NPDWRs
that apply to transient noncommunity
water systems using purchased finished
surface water were used as the baseline
for comparison. The overall change in
risks from each alternative relative to
the Alternative 1 baseline are a result of
the complex interaction of all regulatory
components. EPA used best professional
judgment to qualitatively estimate the
relative risk of each regulatory
alternative. This assessment was made
with contributions from a range of
experts, including public health
scientists, engineers, administrators,
and regulatory experts. The consensus
opinions resulting from the qualitative
assessment of risks for each alternative
relative to the Alternative 1 baseline are
presented here.
Alternative 2
Regulatory Alternative 2 mirrors the
requirements set forth in the AOCs. In
consideration of the regulatory
components, the expert consensus is
that the dominant factor affecting risk is
the periodic disinfection and flushing of
aircraft water systems. This type of
periodic maintenance is important in an
operating environment that is as
variable as that of aircraft water systems.
Though there is currently no data on
how large the marginal effect of
increasing disinfection and flushing
frequency is, any increase in periodicity
for this activity is expected to yield
larger health risk reductions in
comparison to other regulatory
components such as periodic
monitoring.
Based on all the considerations
discussed above, the expert consensus is
that the overall health risk remaining
after Alternative 2 is most likely less
than the baseline.
Alternative 3
The regulatory components of
Alternative 3 are generally not as
comprehensive as Alternative 2, yet are
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similar for those components that are
included in both. In particular, the
disinfection and flushing requirements
are the same for a subset of aircraft in
Alternative 3 (i.e., those that choose to
comply with an O&M plan in lieu of
monitoring). Based on the similarities
between Alternatives 2 and 3, the same
process and rationale was used to
evaluate the two alternatives. Thus, the
expert consensus is similar: the overall
health risk posed by Alternative 3 is
most likely less than the Alternative 1
baseline, though the magnitude of the
difference is expected to be smaller
compared to Alternative 2 due to the
flexibility in choosing between
monitoring and an O&M plan.
The Proposed Rule
The regulatory components of the
proposed rule allow greater flexibility
than Alternatives 2 and 3 with regard to
disinfection and flushing. Thus, some
aircraft will not perform disinfection
and flushing as often as required under
those alternatives. However, this is
compensated for by requiring more
routine monitoring in those situations.
As a result, the expert consensus is that
the overall health risk posed by the
proposed rule is most likely less than
the Alternative 1 baseline, and about the
same as Alternative 2.
B. Assessment of Potential Quantitative
Relative Risk Analyses
In addition to the qualitative relative
risk analysis presented in section VI.A,
EPA has considered analyses for
incorporating quantitative data into a
relative risk analysis. However, EPA is
limited by the purpose, quality, and
quantity of data available in developing
meaningful analyses. Any comparison
of risk between the Alternatives
considered for the proposed rule
requires robust data that would support:
(1) Direct comparisons of the overall
baseline conditions with the overall
conditions under each of the
Alternatives, or (2) comparisons of
specific regulatory components (i.e.,
disinfection and flushing frequencies)
that could be used to compare the
baseline and all Alternatives. As of the
time of proposal, only limited baseline
data and partial data collected under the
AOCs are available for analysis.
Therefore, EPA has determined that it is
not feasible to perform a quantitative
relative risk analysis at this time. As
additional AOC data are received, EPA
will continue to assess the data and
evaluate whether additional quantitative
analyses are possible and can be used to
inform the final ADWR. If EPA
determines that additional quantitative
analyses are feasible, we will provide
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19339
the public with an opportunity to
review the data prior to finalizing the
ADWR.
C. Non-Quantified Benefits
Routine disinfection and flushing
required under the proposed rule is
expected to remove pathogens that may
be living in biofilm in the aircraft
distribution system and contributing to
endemic disease. Disinfection and
flushing associated with corrective
action is also expected to inactivate or
remove any pathogens that may have
entered the distribution system,
resulting in decreased chance of illness.
By reducing the potential for illness
contracted through exposure to aircraft
drinking water, EPA expects that the
implementation of the proposed rule
will reduce the occurrence of illness
passed through secondary spread.
Furthermore, EPA expects the
additional barriers to pathogens
required under the proposed rule,
disinfection and flushing combined
with monitoring and air carrier training
requirements, will reduce the likelihood
of outbreaks associated with aircraft
drinking water.
VII. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review
Under Executive Order (EO) 12866,
(58 FR 51735, October 4, 1993), this
action is a ‘‘significant regulatory
action’’ since it raises novel legal or
policy issues. Accordingly, EPA
submitted this action to the Office of
Management and Budget (OMB) for
review under EO 12866 and any
changes made in response to OMB
recommendations have been
documented in the docket for this
action.
B. Paperwork Reduction Act
The information collection
requirements in this proposed rule have
been submitted for approval to the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act, 44 U.S.C. 3501 et. seq. The
Information Collection Request (ICR)
document prepared by EPA has been
assigned EPA ICR number 2279.01
EPA requires comprehensive and
current information on total coliform
monitoring and associated corrective
action activities to implement its
program oversight and enforcement
responsibilities mandated by the Safe
Drinking Water Act (SDWA). EPA will
use the information collected as a result
of this proposed Aircraft Drinking Water
Rule (ADWR) to support the
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responsibilities outlined in SDWA by
strengthening the implementation of the
proposed ADWR in the areas of
monitoring and flushing and
disinfecting, best management practices,
and public notification, while
decreasing the risk to public health. The
rule requirements described in section
IV of this notice are intended to improve
the implementation from that of the
Total Coliform Rule (TCR) by tailoring
the proposed ADWR to fit the unique
challenges in the maintenance and
operation practices of air carriers, and
do not alter the original maximum
contaminant level goals or the
fundamental approach to controlling
total coliform in drinking water.
Section 1401(1)(D) of SDWA requires
that there must be ‘‘criteria and
procedures to assure a supply of
drinking water which dependably
complies with such maximum
contaminant levels; including accepted
methods for quality control and testing
procedures to insure compliance with
such levels and to insure proper
operation and maintenance of the
system, * * *’’ Furthermore, section
1445(a)(1) of SDWA requires that every
person who is a supplier of water ‘‘shall
establish and maintain such records,
make such reports, conduct such
monitoring, and provide such
information as the Administrator may
reasonably require by regulation to
assist the Administrator in establishing
regulations * * * in determining
whether such person has acted or is
acting in compliance’’ with this title.
Section 1412(b) of SDWA, as amended
in 1996, requires the EPA to publish
maximum contaminant level goals and
promulgate NPDWRs for contaminants
that may have an adverse effect on the
health of persons, are known to or
anticipated to occur in public water
systems, and, in the opinion of the
Administrator, present an opportunity
for health risk reduction. The NPDWRs
specify maximum contaminant levels or
treatment techniques for drinking water
contaminants (42 U.S.C. 300g–1).
Section 1412(b)(9) requires that EPA, no
less than every 6 years, review and if
appropriate, revise existing drinking
water standards. Currently, the Total
Coliform Rule, which established the
regulatory standards (i.e., maximum
contaminant level goals and treatment
techniques) by which this proposed
ADWR is based, is being revised in
accordance with the finding of the
EPA’s first Six-Year Review (68 FR
42907, July 18, 2003). Promulgation of
the ADWR complies with these
statutory requirements.
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Burden Estimate
The universe of respondents for this
Information Collection Request (ICR) is
comprised of 63 air carriers that operate
approximately 7,327 aircraft public
water systems, classified as Transient
Non-Community Water Systems and the
ten EPA Regions. The burden per
response for air carriers is about 0.3
hours with a cost per response of
approximately $31. The average annual
burden per air carrier respondent is 535
hours or about 5 hours per aircraft. The
average annual cost per air carrier
respondent is $61,968 or $534 per
aircraft. The total burden incurred by air
carriers during the 3-year period
covered by this ICR is 101,155 hours
which equates to about 1606 hours per
air carrier and 14 hours per aircraft. The
total estimated capital and start-up costs
(including operation and maintenance)
for the ICR are estimated to be
$7,809,188.
Burden means the total time, effort, or
financial resources expended by persons
to generate, maintain, retain, or disclose
or provide information to or for a
Federal agency. This includes the time
needed to review instructions; develop,
acquire, install, and utilize technology
and systems for the purposes of
collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements; train personnel to be able
to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
An agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in 40
CFR are listed in 40 CFR part 9. When
this ICR is approved by OMB, the EPA
will publish a technical amendment to
40 CFR part 9 in the Federal Register to
display the OMB control number for the
approved information collection
requirements contained in this final
rule.
To comment on the EPA’s need for
this information, the accuracy of the
provided burden estimates, and any
suggested methods for minimizing
respondent burden, including the use of
automated collection techniques, EPA
has established a public docket for this
rule, which includes this ICR, under
Docket ID No. EPA–HQ–OW–2005–
0025. Submit any comments related to
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the ICR for this proposed rule to EPA
and OMB. See ADDRESSES section at the
beginning of this notice for where to
submit comments to EPA. Send
comments to OMB at the Office of
Information and Regulatory Affairs,
Office of Management and Budget, 725
17th Street, NW., Washington, DC
20503, Attention: Desk Officer for EPA.
Since OMB is required to make a
decision concerning the ICR between 30
and 60 days after April 9, 2008, a
comment to OMB is best assured of
having its full effect if OMB receives it
by May 9, 2008. The final rule will
respond to any OMB or public
comments on the information collection
requirements contained in this proposal.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
generally requires an agency to prepare
a regulatory flexibility analysis of any
rule subject to notice and comment
rulemaking requirements under the
Administrative Procedure Act or any
other statute unless the agency certifies
that the rule will not have a significant
economic impact on a substantial
number of small entities. Small entities
include small businesses, small
organizations, and small governmental
jurisdictions.
The RFA provides default definitions
for each type of small entity. Small
entities are defined under the RFA as:
(1) A small business as defined by the
Small Business Administration’s (SBA)
regulations at 13 CFR 121.201; (2) a
small governmental jurisdiction that is a
government of a city, county, town,
school district or special district with a
population of less than 50,000; and (3)
a small organization that is any ‘‘not-forprofit enterprise which is independently
owned and operated and is not
dominant in its field.’’ However, the
RFA also authorizes an agency to use
alternative definitions for each category
of small entity, ‘‘which are appropriate
to the activities of the agency’’ after
proposing the alternative definition(s) in
the Federal Register and taking
comment. 5 U.S.C. 601(3)–(5). In
addition, to establish an alternative
small business definition, agencies must
consult with SBA’s Chief Counsel for
Advocacy. For purposes of assessing the
impacts of drinking water regulations on
small entities under the RFA, EPA has
defined small entities as public water
systems serving 10,000 or fewer persons
(see EPA’s Consumer Confidence
Reports regulation, 63 FR 44511, August
19, 1998).
However, for purposes of assessing
the economic impacts of this proposed
rule on small entities, EPA is proposing
to define ‘‘small entity’’ using the SBA
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standard as air carriers (NAICS codes
481111 and 481211) having fewer than
1,500 employees (13 CFR 121.201)
rather than using the definition EPA has
used for small stationary public water
systems (‘‘a public water system that
serves 10,000 or fewer people’’). As
discussed in section II.B, many of the
requirements under the existing
NPDWR have proven difficult to
implement when applied to mobile
aircraft water systems that are
operationally very different from
traditional water systems. Under the
proposed ADWR, the air carrier is the
business entity rather than the
individual aircraft water system.
Therefore, EPA is proposing to use the
SBA standard based on the number of
air carrier employees instead of
population served by each aircraft water
system. The Agency is interested in
receiving comments on the use of this
alternative definition of small entity.
In addition, the Agency has consulted
with the SBA Chief Counsel for
Advocacy on using the SBA small
business definition of fewer than 1500
employees for purposes of assessing the
economic impacts of this rule on small
entities. As a result of this consultation,
SBA agrees with the Agency’s approach
to the small entity definition for air
carriers for this proposed rule. However,
SBA did request that EPA verify that
they have captured the entire universe
of small entities that may be impacted
by the proposed rule. SBA
recommended that EPA contact two
additional aviation and air
transportation associations to determine
whether there may be additional entities
that may experience a significant
economic impact as a result of this
proposed rule, which were not
accounted for in the Agency’s earlier
analysis. EPA contacted those
associations and they confirmed the
Agency’s earlier findings from other
sources, including the FAA, that EPA
had taken into account all available
information on the universe of small
entities during the Agency’s earlier
analysis.
EPA also is proposing to use this
alternative definition of ‘‘small entity’’
for purposes of its regulatory flexibility
assessments under the RFA for this rule,
revisions to this rule, and any future
drinking water regulations that address
air carriers.
After considering the economic
impacts of this proposed rule on small
entities, I certify that this action will not
have a significant economic impact on
a substantial number of small entities.
EPA has determined that the following
businesses would be affected by the
proposed Aircraft Drinking Water Rule:
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scheduled passenger air transportation
(NAICS 481111) and nonscheduled
chartered passenger air transportation
(481211). Of the 63 air carriers
estimated to be affected by this rule, 30
are small businesses; however, this
represents less than one percent of total
service to the U.S. population. We have
determined that 1 small business air
carrier could experience an impact of
1.4 percent of its average annual
revenue. This represents 3.3 percent of
all small air carriers.
Although this proposed rule will not
impact a substantial number of small
entities, we continue to be interested in
the potential impacts of the proposed
rule on small entities and welcome
comments on issues related to such
impacts.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Public
Law 104–4, establishes requirements for
Federal agencies to assess the effects of
their regulatory actions on State, local,
and Tribal governments and the private
sector. Under section 202 of UMRA,
EPA generally must prepare a written
statement, including a cost-benefit
analysis, for proposed and final rules
with ‘‘Federal mandates’’ that may
result in expenditures to State, local,
and Tribal governments, in the
aggregate, or to the private sector, of
$100 million or more in any one year.
Before promulgating an EPA rule for
which a written statement is needed,
section 205 of the UMRA generally
requires EPA to identify and consider a
reasonable number of regulatory
alternatives and adopt the least costly,
most cost-effective or least burdensome
alternative that achieves the objectives
of the rule. The provisions of section
205 do not apply when they are
inconsistent with applicable law.
Moreover, section 205 allows EPA to
adopt an alternative other than the least
costly, most cost-effective or least
burdensome alternative if the
Administrator publishes with the final
rule an explanation as to why that
alternative was not adopted. Before EPA
establishes any regulatory requirements
that may significantly or uniquely affect
small governments, including Tribal
governments, it must have developed
under section 203 of the UMRA a small
government agency plan. The plan must
provide for notifying potentially
affected small governments, enabling
officials of affected small governments
to have meaningful and timely input in
the development of EPA regulatory
proposals with significant Federal
intergovernmental mandates, and
informing, educating, and advising
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small governments on compliance with
the regulatory requirements.
EPA has determined that this
proposed regulatory action does not
contain a Federal mandate that may
result in expenditures of $100 million or
more for State, local, and tribal
governments, in the aggregate, or the
private sector in any one year. Annual
costs to air carriers include the costs of
administration, monitoring, corrective
action, self-inspection and compliance
audits. EPA estimates the annualized
compliance cost to air carriers of $7.9
million (3 percent discount rate) and
$8.0 million (7 percent discount rate).
States, local, and Tribal governments,
however, will not incur annual costs
associated with this proposed rule,
since oversight of air carriers (i.e.,
interstate commerce carriers) is directly
implemented by EPA and EPA will
incur costs associated with this
rulemaking. Thus, this rule is not
subject to the requirements of sections
202 and 205 of the UMRA. For these
reasons, EPA has also determined that
this rule contains no regulatory
requirements that might significantly or
uniquely affect small governments.
E. Executive Order 13132: Federalism
Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999), requires EPA to develop an
accountable process to ensure
‘‘meaningful and timely input by State
and local officials in the development of
regulatory policies that have federalism
implications.’’ ‘‘Policies that have
federalism implications’’ is defined in
the Executive Order to include
regulations that have ‘‘substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’
This proposed rule does not have
federalism implications. It will not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132. States are not
directly affected by any requirements in
this rule, since oversight of air carriers
(i.e., interstate commerce carriers) is
implemented by EPA. Thus, Executive
Order 13132 does not apply to this rule.
In the spirit of Executive Order 13132,
and consistent with EPA policy to
promote communications between EPA
and State and local governments, EPA
specifically solicits comment on this
proposed rule from State and local
officials.
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F. Executive Order 13175: Consultation
and Coordination With Indian
Governments
enhance more effective protection of
public health, including the health of
children who are aircraft passengers.
Executive Order 13175, entitled
‘‘Consultation and Coordination with
Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), requires EPA
to develop an accountable process to
ensure ‘‘meaningful and timely input by
tribal officials in the development of
regulatory policies that have tribal
implications.’’ This proposed rule does
not have tribal implications, as specified
in Executive Order 13175. It does not
significantly or uniquely affect the
communities of Indian tribal
governments, nor does it impose
substantial direct compliance costs on
those communities. The provisions of
this proposed rule apply to all aircraft
transient non-community water
systems. At present, EPA has not
identified any Tribal governments that
may be owners/air carriers of such
systems. Thus, Executive Order 13175
does not apply to this rule.
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
This proposed rule is not a
‘‘significant energy action’’ as defined in
Executive Order 13211, ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001) because it is not likely to have
a significant adverse effect on the
supply, distribution, or use of energy.
The proposed rule addresses the unique
implementation challenges facing
aircraft water systems.
This proposed rule does not affect the
supply of energy as it does not regulate
power generation. The proposed rule
does not regulate any aspect of energy
distribution as the aircraft covered by
the proposed ADWR already have their
own power source. Finally, these
regulatory revisions do not adversely
affect the use of energy as EPA does not
anticipate that a significant number of
air carriers will add treatment
technologies that use electrical power to
comply with these regulatory revisions.
As such, EPA does not anticipate that
this proposed rule will adversely affect
the use of energy.
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G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
Executive Order 13045 ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997) applies to any rule that:
(1) Is determined to be ‘‘economically
significant’’ as defined under Executive
Order 12866, and (2) concerns an
environmental health or safety risk that
EPA has reason to believe may have a
disproportionate effect on children. If
the regulatory action meets both criteria,
the Agency must evaluate the
environmental health or safety effects of
the planned rule on children, and
explain why the planned regulation is
preferable to other potentially effective
and reasonably feasible alternatives
considered by the Agency.
While this proposed rule is not
subject to the Executive Order because
it is not economically significant as
defined in Executive Order 12866, we
nonetheless have reason to believe that
the environmental health or safety risk
addressed by this action can have an
effect on children. This proposed rule
does not change the core Total Coliform
Rule requirements in place to assure the
protection of children from the effects of
contaminants in drinking water. Rather
this proposed rule, which is tailored to
meet the specific challenges in the
maintenance and operations of aircraft
water systems, will improve the
implementation of the current
provisions under the Total Coliform
Rule for aircraft water systems, and
thereby, is expected to ensure and
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I. National Technology Transfer and
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (‘‘NTTAA’’), Public Law
104–113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus standards
bodies. The NTTAA directs EPA to
provide Congress, through OMB,
explanations when the Agency decides
not to use available and applicable
voluntary consensus standards.
The proposed rule may involve
voluntary consensus standards in that it
would require monitoring for total
coliform, and monitoring and sample
analysis methodologies are often based
on voluntary consensus standards.
However, the proposed rule does not
change any methodological
requirements for monitoring or sample
analysis as are indicated in the Total
Coliform Rule; only, in some cases, the
required frequency and number of
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samples. Also, EPA’s approved
monitoring and sampling protocols
generally include voluntary consensus
standards developed by agencies such
as the American National Standards
Institute (ANSI) and other such bodies
wherever EPA deems these
methodologies appropriate for
compliance monitoring.
EPA welcomes comments on this
aspect of the proposed rulemaking and,
specifically, invites the public to
identify potentially-applicable
voluntary consensus standards and to
explain why such standards should be
used in this regulation.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order (EO) 12898 (59 FR
7629 (Feb. 16, 1994)) establishes federal
executive policy on environmental
justice. Its main provision directs
federal agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations and low-income
populations in the United States.
EPA has determined that this
proposed rule will not have
disproportionately high and adverse
human health or environmental effects
on minority or low-income populations
because it increases the level of
environmental protection for all affected
populations without having any
disproportionately high and adverse
human health or environmental effects
on any population, including any
minority or low-income population.
K. Consultations With the Science
Advisory Board, National Drinking
Water Advisory Council, and the
Secretary of Health and Human Services
In accordance with sections 1412(d)
and 1412(e) of the Safe Drinking Water
Act (SDWA), the Agency consulted with
the National Drinking Water Advisory
Council (NDWAC or the Council); the
Secretary of Health and Human
Services; and requested a consultation
with the Science Advisory Board, which
will take place in 2008.
The Agency consulted with NDWAC
during the Council’s May 25–27, 2007,
semi-annual meeting. In general,
NDWAC recommended that EPA
consider and request public comment
on best management practices (BMPs)
and public notification requirements,
which may be feasible alternatives for
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the air carrier industry while providing
greater public health protection. EPA
has incorporated these
recommendations into the proposed
ADWR by providing flexible BMP
alternatives and timely notification
requirements which have been tailored
specifically to meet the unique
operational characteristics of aircraft
public water systems and the air carrier
industry. EPA has expressly requested
public comment in these areas of the
proposed ADWR.
On August 8, 2007, EPA consulted
with the Department of Health and
Human Services (HHS). EPA received a
favorable response to the Agency’s
novel approach and development of the
proposed ADWR and no issues were
raised as a result of the consultation.
L. Plain Language
Executive Order 12866 encourages
Federal agencies to write rules in plain
language. EPA invites comments on
how to make this proposed rule easier
to understand. For example: Has EPA
organized the material to suit
commenters’ needs? Are the
requirements in the rule clearly stated?
Does the rule contain technical language
or jargon that is not clear? Would a
different format (e.g., grouping and
ordering of sections, use of headings,
paragraphs) make the rule easier to
understand? Could EPA improve clarity
by adding tables, lists, or diagrams?
What else could EPA do to make the
rule easier to understand?
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VIII. References
ATA (Air Transport Association of America,
Inc.) 2003. Air Transport Association:
Aircraft Drinking Water Sampling Program,
Final Report: December 31, 2003. https://
www.airlines.org.
Canada. 2007a. Health Canada. Healthy
Living. Aircraft Inspection Program—
Frequently Asked Questions. https://
www.hc-sc.gc.ca/hl-vs/travel-voyage/
general/inspection/airplaneaeronefs_e.html.
Canada. 2007b. Health Canada. Healthy
Living. Advisory. Health Canada cautions
air travelers with compromised immune
systems regarding water quality on aircraft.
https://www.hc-sc.gc.ca/ahc-asc/media/
advisories-avis/2006/2006_53_e.html.
Davison, A., Howard, G., Stevens, M., et al.
2005. Water, Sanitation and Health
Protection and the Human Environment,
World Health Organization, Geneva. Water
Safety Plans: Managing drinking-water
quality from catchment to consumer.
https://www.who.int/
water_sanitation_health/.
Lehtola, M., Torvinen, E., Kusnetsov, J., et al.
2007. Survival of Mycrobacterium avium,
Legionella pneumophila, Escherichia coli,
and Caliciviruses in Drinking WaterAssociated Biofilms Grown under HighShear Turbulent Flow. Applied and
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Environmental Microbiology, 73:2854–
2859.
USEPA. 1986. Water Supply Guidance 29:
Plan for Implementation of the Safe
Drinking Water Act on Interstate Carrier
Conveyance.
USEPA. 1989. National Interim Primary
Drinking Water Regulations; Total Coliform
Rule; Final Rule. Part III. Federal Register,
54:124:27544. (June 29, 1989).
USEPA. 2008. Economic and Supporting
Analyses; Proposed Aircraft Drinking
Water Rule. EPA 816–D–08–002.
USEP. 2008. DRAFT Information Collection
Request for the National Primary Drinking
Water Regulations: Proposed Aircraft
Drinking Water Rule. EPA 816–D–08–001.
USFDA. 2005. Title 21—Food and Drugs,
Chapter 1—Food and Drug Administration,
Part 1250—Interstate Conveyance
Sanitation. https://www.accessdata.
fda.gov/.
WHO. 1997. HACCP—Introducing the
Hazard Analysis and Critical Control Point
System. Geneva, Switzerland: WHO.
WHO. 2004. Guidelines for Drinking-Water
Quality. 3rd Edition, Volume 1—
Recommendations, Chapter 4 Water
Supply Plans. Geneva, Switzerland: WHO.
List of Subjects in 40 CFR Part 141
Environmental protection, Chemicals,
Indians-lands, Intergovernmental
relations, Radiation protection,
Reporting and recordkeeping
requirements, Water supply.
Dated: March 28, 2008.
Stephen L. Johnson,
Administrator.
For the reasons set out in the
preamble, title 40, chapter 1 of the Code
of Federal Regulations is proposed to be
amended as follows:
PART 141—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
1. The authority citation for part 141
continues to read as follows:
Authority: 42 U.S.C. 300f, 300g–1, 300g–2,
300g–3, 300g–4, 300g–5, 300g–6, 300j–4,
300j–9, and 300j–11.
2. Part 141 is amended by adding a
new subpart X to read as follows:
Subpart X—Aircraft Drinking Water Rule
Sec.
141.800 Applicability and compliance date.
141.801 Definitions.
141.802 Coliform sampling plan.
141.803 Coliform sampling.
141.804 Aircraft water system operations
and maintenance plan.
141.805 Notification of passengers and
crew.
141.806 Reporting requirements.
141.807 Recordkeeping requirements.
141.808 Audits and inspections.
141.809 Supplemental treatment.
141.810 Violations.
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Subpart X —Aircraft Drinking Water
Rule
§ 141.800
date.
Applicability and compliance
The requirements of this subpart
constitute the National Primary
Drinking Water Regulations for aircraft
that are public water systems, which
board only finished water for human
consumption. To the extent there is a
conflict between the requirements in
this subpart and the regulatory
requirements established elsewhere in
this part, this subpart governs.
Compliance Date. Aircraft public water
systems must comply, unless otherwise
noted, with the requirements of this
subpart beginning [DATE 12 MONTHS
AFTER FINAL RULE IS PUBLISHED IN
THE Federal Register].
§ 141.801
Definitions.
As used in this subpart, the term:
Administrator means the
Administrator of the United States
Environmental Protection Agency or his
authorized representative.
Air carrier means a person who
undertakes directly by lease, or other
arrangement, to engage in air
transportation. The air carrier is
responsible for ensuring all of the
aircraft it owns or operates that are
public water systems comply with all
provisions of this subpart.
Aircraft means a device that is used
or intended to be used for flight in the
air.
Aircraft water system means an
aircraft that qualifies as a public water
system under the Safe Drinking Water
Act and the National Primary Drinking
Water Regulations. The components of
an aircraft water system include the
water service panel, the filler neck of
the aircraft finished water storage tank,
and all finished water storage tanks,
piping, treatment equipment, and
plumbing fixtures within the aircraft
that supply water to passengers or crew.
Aircraft water system operation and
maintenance plan means the schedules
and procedures for operating,
monitoring, and maintaining an aircraft
water system that is included in an
aircraft operation and maintenance
program approved or accepted by the
Federal Aviation Administration. (14
CFR Part 43, 14 CFR Part 91, 14 CFR
Part 121).
Finished water means water that is
introduced into the distribution system
of a public water system and is intended
for distribution and consumption
without further treatment, except as
treatment necessary to maintain water
quality in the distribution system (e.g.,
supplemental disinfection, addition of
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corrosion control chemicals). (40 CFR
141.2). Human consumption means
drinking, bathing, showering, hand
washing, teeth brushing food
preparation, dishwashing, and
maintaining oral hygiene.
Self inspection means an onsite
review of the aircraft water system,
including the water service panel, the
filler neck of the aircraft finished water
storage tank; all finished water storage
tanks, piping, treatment equipment, and
plumbing fixtures; and a review of the
aircraft operations, maintenance,
monitoring, and recordkeeping for the
purpose of evaluating the adequacy of
such water system components and
practices for providing safe drinking
water to passengers and crew.
Watering point means a facility where
finished water is transferred from a
water supply to the aircraft. These
facilities may include water trucks,
carts, cabinets, and hoses.
§ 141.802
Coliform sampling plan.
(a) Each air carrier under this subpart
must develop a coliform sampling plan
covering each aircraft water system
owned or operated by the air carrier that
identifies the following:
(1) Coliform sample collection
procedures.
(2) Sample tap location(s)
representative of the aircraft water
system per § 141.803(b)(2) and (b)(3).
(3) Frequency and number of routine
coliform samples to be collected.
(4) Frequency of routine disinfection
and flushing as specified in the
operation and maintenance plan under
§ 141.804.
(5) Procedures for communicating
sample results promptly so that any
required actions including repeat and
follow-up sampling, corrective action,
and notification of passengers and crew
may be conducted in a timely manner.
(b) Aircraft with a water system
meeting the definition of a PWS, must
be covered by a coliform sampling plan
by [DATE 6 MONTHS AFTER FINAL
RULE IS PUBLISHED IN THE Federal
Register].
(c) The coliform sampling plan must
be included in the Aircraft Water
System Operation and Maintenance
Plan required in § 141.804.
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§ 141.803
Coliform sampling.
(a) Analytical Methods. (1) Coliform
sampling of aircraft public water
systems under this section need only
determine the presence or absence of
total coliforms; a determination of total
coliform density is not required.
(2) EPA approved analytical
methodologies must be used for the
analysis of coliform bacteria. The
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invalidation of a total coliform sample
result can only be made by the
Administrator in accordance with
§ 141.21(c)(1)(i), (ii), or (iii) or by the
State or EPA certified laboratory in
accordance with § 141.21(c)(2).
(b) Routine Monitoring. For each
aircraft water system, the air carrier
must collect two 100 mL total coliform
routine samples at the frequency
specified in the sampling plan in
§ 141.802. The sampling frequency must
be determined by the disinfection and
flushing frequency recommended by the
aircraft water system manufacturer and
as identified in the operation and
maintenance plan in § 141.804.
(1) Routine monitoring frequencies
must be as follows:
(i) If the aircraft water system is
disinfected and flushed at least
quarterly, then coliform monitoring
must occur at least annually, or
(ii) If the aircraft water system is
disinfected and flushed one to three
times per year, then coliform monitoring
must occur at least quarterly, or
(iii) If the aircraft water system is
disinfected and flushed less than once
per year, then coliform monitoring must
occur at least monthly.
(2) One sample must be taken from a
lavatory and one sample from a galley;
each must be analyzed for total
coliform.
(3) If only one water tap is located in
the aircraft water system due to aircraft
model type and construction, then a
single tap may be used to collect two
separate 100 mL samples.
(4) If any routine coliform sample is
total coliform-positive, the air carrier
must analyze that total coliform-positive
culture medium to determine if fecal
coliforms are present, except that the
system may test for E. coli in lieu of
fecal coliforms.
(5) Routine coliform samples must not
be collected within 72 hours after
completing disinfection and flushing
procedures.
(c) Coliform Sample Results. (1)
Negative Routine Coliform Sample
Results. If no routine sample is total
coliform-positive, then the air carrier
must maintain the routine monitoring
frequency for total coliform as specified
in paragraph (b) of this section.
(2) Single Routine Total ColiformPositive Sample Result that is Fecal/E.
coli-negative. In response to a single
routine total coliform-positive sample
result that is fecal/E. coli negative, the
air carrier must perform at least one of
the following:
(i) Disinfection and Flushing. In
accordance with § 141.804, initiate
disinfection and flushing of the system
no later than 72 hours after the
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laboratory notifies the air carrier of the
total coliform-positive result. After
disinfection and flushing are completed,
the air carrier must collect follow-up
samples in accordance with paragraph
(d) of this section.
(ii) Repeat Sampling. Collect four 100
mL repeat samples no later than 24
hours after the laboratory notifies the air
carrier of the total coliform-positive
result. Repeat samples must be collected
and analyzed from four taps within the
aircraft as follows: the tap which
resulted in the total coliform-positive
sample, one other lavatory tap, one
other galley tap, and one other tap; if
less than four taps exist, then a total of
four 100 mL samples must be collected
and analyzed from the available taps
within the aircraft water system. If no
repeat sample is total coliform-positive,
then the aircraft water system must
maintain the routine monitoring
frequency for coliform as specified in
paragraph (b) of this section. If any
repeat coliform sample is total coliformpositive, the aircraft water system must
analyze that total coliform-positive
culture medium to determine if fecal
coliforms are present, except that the air
carrier may test for E. coli in lieu of
fecal coliforms.
(3) If any routine or repeat sample is
fecal coliform-positive or E. colipositive, then the air carrier must
perform all of the following:
(i) Restrict public access to the aircraft
water system in accordance with
paragraph (c)(5) of this section as
expeditiously as possible, but in no case
later than 24 hours after being notified
of the positive result by the laboratory;
(ii) Conduct disinfection and flushing
pursuant to § 141.804 prior to
resumption of unrestricted public access
to the aircraft water system, or no later
than 72 hours if the aircraft water
system cannot be physically
disconnected/shut off to the crew and
passengers as stated in § 141.804(b)(8);
and
(iii) Collect follow-up samples
pursuant to paragraph (d) of this
section.
(4) If more than one routine sample or
any repeat sample is total coliformpositive and fecal coliform-negative (or
E. coli-negative), then the air carrier
must perform all of the following:
(i) Restrict public access to the aircraft
water system in accordance with
paragraph (c)(5) of this section as
expeditiously as possible, but in no case
later than 24 hours after being notified
of the positive result by the laboratory;
(ii) Conduct disinfection and flushing
pursuant to § 141.804 prior to
resumption of unrestricted public access
to the aircraft water system, or no later
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than 72 hours if the aircraft water
system cannot be physically
disconnected/shut off to the crew and
passengers as stated in § 141.804(b)(8);
and
(iii) Collect follow-up samples
pursuant to paragraph (d) of this
section.
(5) Restriction of public access
includes, but need not be limited to, the
following:
(i) Physically disconnecting or
shutting off the aircraft water system
where feasible;
(ii) Providing public notification to
passengers and crew in accordance with
§ 141.805; and
(iii) Providing alternatives to use of
the aircraft water system, such as
bottled water for drinking and coffee
preparation; antiseptic alcohol based
hand gels or wipes in the galley and
lavatories, and other feasible measures
that reduce or eliminate the need to use
the aircraft water system during the
limited period before public use of the
aircraft water system is restored.
(d) Post Disinfection and Flushing
Follow-up Sampling. Following a
coliform-positive that requires
disinfection and flushing, air carriers
must comply with post disinfection and
flushing follow-up sampling procedures
that, at a minimum, consist of the
following:
(1) For each aircraft water system, the
air carrier must collect coliform followup samples consisting of two 100 mL
total coliform samples at the same
routine sample locations as identified in
paragraphs (b)(2) and (3) of this section.
(2) If one or more of the follow-up
samples is total coliform-positive then,
as a minimum, the air carrier must redisinfect and flush the aircraft water
system in accordance with
§ 141.804(b)(2) and take additional
follow-up samples in accordance with
paragraph (d)(1) of this section.
(3) All follow-up sample results must
be total coliform-negative before the air
carrier provides water from the aircraft
water system to passengers and crew
and returns to the routine monitoring
frequency for coliform as specified in
paragraph (b) of this section.
(e) Failure to Collect Required Routine
Samples. If there was a failure to collect
and analyze the required number of
routine coliform samples, the air carrier
must:
(1) Notify passengers and crew in
accordance with § 141.805 as
expeditiously as possible, but in no case
later than 24 hours after discovery of
failure to collect required samples or
after being notified by EPA of failure to
collect required samples, and
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(2) Conduct disinfection and flushing
within 72 hours in accordance with
§ 141.804(b)(2).
(3) Collect follow-up samples
pursuant to paragraph (d) of this
section.
(f) Failure to Collect Repeat or Followup Samples: If there was a failure to
collect and analyze the required number
of repeat or follow-up samples, then the
air carrier must:
(1) Restrict public access to the
aircraft water system in accordance with
paragraph (c)(5) of this section as
expeditiously as possible, but in no case
later than 24 hours after discovery of
failure to collect required samples or
after being notified by EPA of failure to
collect required samples.
(2) Conduct disinfection and flushing
pursuant to § 141.804 prior to
resumption of unrestricted public access
to the aircraft water system, or no later
than 72 hours if the aircraft water
system cannot be physically
disconnected/shut off to the crew and
passengers as stated in § 141.804(b)(8);
and
(3) Collect follow-up samples
pursuant to paragraph (d) of this
section.
§ 141.804 Aircraft water system operations
and maintenance plan.
(a) Each air carrier must have and
follow an aircraft water system
operation and maintenance plan for
each aircraft water system that it owns
or operates. This plan must be included
in a Federal Aviation Administration
approved or accepted air carrier
operations and maintenance program
(14 CFR Part 43, 14 CFR Part 91, 14 CFR
Part 121).
(b) Each aircraft water system
operation and maintenance plan must
include the following:
(1) Watering Point Selection
Requirement. All water sources must be
from a Food and Drug Administration
(FDA) approved watering point in
accordance with 21 CFR 1240.80.
(2) Procedures for Disinfection and
Flushing of Aircraft Water System.
(i) The air carrier must conduct
disinfection and flushing of the aircraft
water system in accordance with or be
no less stringent than the water system
manufacturer’s recommendations. The
air carrier may conduct disinfection and
flushing more frequently, but not less
frequently, than the manufacturer
recommends.
(ii) The operation and maintenance
plan must identify the disinfection
frequency, type of disinfecting agent,
disinfectant concentration to be used,
and the disinfectant contact time, and
flushing volume or flushing time.
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19345
(iii) In cases where a recommended
routine disinfection and flushing
frequency is not specified by the aircraft
water system manufacturer, the air
carrier must perform disinfection and
flushing of each aircraft water system no
less frequently than quarterly.
(3) Procedures for follow-up sampling
in accordance with § 141.803(d).
(4) Training Requirements. Training
for all personnel involved with the
aircraft water system operation and
maintenance provisions of this
regulation must include, but is not
limited to:
(i) Water boarding procedures;
(ii) Sample collection procedures;
(iii) Disinfection and flushing
procedures;
(iv) Public health and safety reasons
for the requirements of this subpart.
(5) Procedures for Conducting Selfinspections of the Aircraft Water
System. Procedures must include, but
are not limited to, inspection of: Storage
tank, distribution system, supplemental
treatment, fixtures, valves, and backflow
prevention devices.
(6) Procedures for Boarding Water.
(i) Within the United States, the air
carrier must board water from an
approved FDA watering point.
(ii) The operation and maintenance
plan must include a description of how
the carrier will ensure that water
boarded outside the United States is safe
for human consumption.
(iii) In no event should the air carrier
knowingly serve water that violates
NPDWRs. If water must be boarded that
is known to violate NPDWRs, the carrier
must meet the requirements in
§ 141.803(c)(3).
(iv) The operation and maintenance
plan must provide a description of how
the water will be transferred from the
watering point to the aircraft in a
manner that ensures it will not become
contaminated during the transfer.
(v) The operation and maintenance
plan must also describe emergency
procedures to be used in the event that
water is boarded to operate essential
systems, such as toilets, but is not
boarded from an FDA approved or
otherwise safe watering point, as
specified above, including:
(A) Notification of passengers and
crew in accordance with § 141.805 as
expeditiously as possible, but in no case
later than 24 hours after boarding the
water, and
(B) Conducting disinfection and
flushing within 72 hours in accordance
with (b)(2) of this section.
(C) Collect follow-up samples
pursuant to § 141.803(d) of this section.
(7) Coliform Sampling Plan. The air
carrier must include the coliform
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sampling plan prepared in accordance
with § 141.802.
(8) A statement as to whether the
aircraft water system can be physically
disconnected/shut off to the crew and
passengers.
(c) For existing aircraft, the air carrier
must develop their operations and
maintenance plan required by this
section by [DATE 6 MONTHS AFTER
FINAL RULE IS PUBLISHED IN THE
Federal Register];
(d) For new aircraft, the air carrier
must develop the operations and
maintenance plan required by § 141.804
within the first calendar quarter of
initial operation of the aircraft.
rwilkins on PROD1PC63 with PROPOSALS3
§ 141.805
crew.
Notification of passengers and
(a) Air Carriers must give notice for
each aircraft in all of the following
situations where:
(1) Public access to the aircraft water
system is required to be restricted, in
accordance with § 141.803(c)(3) or (4);
(2) There has been a failure to collect
required samples, in accordance with
§ 141.803(e) or (f);
(3) Water has been boarded from a
watering point that has not been
approved by FDA, or otherwise
determined to be safe in accordance
with the procedures specified in
§ 141.804(b)(6); and
(4) The Administrator, the carrier, or
the crew otherwise determine that
notification is necessary to protect
public health.
(b) Air carriers must provide
notification to passengers and crew
within 24 hours of being informed of
sample results or other events which
trigger notification, or within 24 hours
of being informed by EPA to perform
notification, whichever occurs first.
Notification must be in a form and
manner reasonably calculated to reach
all passengers and crew while onboard
the aircraft by using one or more of the
following forms of delivery:
(1) Broadcast over public
announcement system on aircraft;
(2) Posting of the notice in
conspicuous locations throughout the
area served by the water system. These
locations would normally be the galleys
and in the lavatories of each aircraft
requiring posting;
(3) Hand delivery of the notice to
passengers and crew;
(4) Another delivery method
approved in writing by the
Administrator.
(c) All notification must continue
until all follow-up coliform samples are
total coliform-negative. Each notice:
(1) Must be displayed in a
conspicuous way when printed or
posted;
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(2) Must not contain overly technical
language or very small print;
(3) Must not be formatted in a way
that defeats the purpose of the notice;
(4) Must not contain language that
nullifies the purpose of the notice;
(5) Must contain information in the
appropriate language(s) regarding the
importance of the notice reflecting a
good faith effort to reach the nonEnglish speaking population served,
including where applicable, an easily
recognized symbol for non-potable
water.
(d) Notice when public access to the
aircraft water system is restricted must
include:
(1) A prominently-displayed, clear
statement in each lavatory indicating
that the water is non-potable and should
not be used for drinking, food or
beverage preparation, hand washing,
teeth brushing, or any other
consumptive use; and
(2) A prominent notice in the galley
directed at the crew which includes:
(i) A clear statement that the water is
non-potable and should not be used for
drinking, food or beverage preparation,
hand washing, teeth brushing, or any
other consumptive use;
(ii) A description of the violation or
situation triggering the notice, including
the contaminant(s) of concern;
(iii) When the violation or situation
occurred;
(iv) Any potential adverse health
effects from the violation or situation, as
appropriate, under paragraph (g) of this
section.
(v) The population at risk, including
sensitive subpopulations particularly
vulnerable if exposed to the
contaminant in the drinking water;
(vi) What the air carrier is doing to
correct the violation or situation; and
(vii) When the air carrier expects to
return the system to unrestricted access;
(e) If access to the water system by
passengers is physically prevented
through disconnecting or shutting off
the water, or if water is supplied only
to lavatory toilets, and not to any
lavatory taps, then only the notice
specified in paragraph (d)(2) of this
section is required.
(f) Notice when water has been
boarded from a watering point not
approved by FDA or otherwise
determined to be safe in accordance
with the procedures in § 141.804(b)(6),
or when required monitoring or
required disinfection and flushing was
not conducted must include:
(1) A prominently-displayed, clear
statement in each lavatory indicating
that the water is non-potable and should
not be used for drinking, food or
beverage preparation, or teeth brushing;
and
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(2) A prominent notice in the galley
directed at the crew which includes:
(i) A clear statement that the water is
non-potable and should not be used for
drinking, food or beverage preparation,
or teeth brushing;
(ii) An indication that water was
boarded from a watering point that has
not been approved by FDA, or otherwise
determined to be safe in accordance
with the procedures specified in
§ 141.804(b)(6), or that required
monitoring or required disinfection and
flushing was not conducted, and it is
thus not known whether the water is
contaminated;
(iii) When and where the water was
boarded or the specific monitoring or
disinfection and flushing requirement
was not met;
(iv) Any potential adverse health
effects from exposure to waterborne
pathogens that might be in the water;
(v) The population at risk, including
sensitive subpopulations particularly
vulnerable if exposed to the
contaminant in the drinking water; and
(vi) A statement indicating when the
system will be disinfected and flushed
and returned to full service if known;
(g) The following standard health
effects language must be included in
each public notice to the crew.
(1) Health effects language to be used
when notice was triggered by detection
of total coliforms only (not fecal
coliforms or E. coli):
Coliform are bacteria that are naturally
present in the environment and are used as
an indicator that other, potentially harmful,
bacteria may be present. Coliforms were
found in [INSERT NUMBER OF SAMPLES
DETECTED] samples collected and this is a
warning of potential problems. If human
pathogens are present, they can cause shortterm health effects, such as diarrhea, cramps,
nausea, headaches, or other symptoms. They
may pose a special health risk for infants,
young children, some of the elderly, and
people with severely compromised immune
systems.
(2) Health effects language to be used
when any routine or repeat sample is
fecal coliform positive or E. coli
positive:
Fecal coliform and E. coli are bacteria
whose presence indicates that the water may
be contaminated with human or animal
wastes. Microbes in these wastes can cause
short-term health effects, such as diarrhea,
cramps, nausea, headaches, or other
symptoms. They may pose a special health
risk for infants, young children, some of the
elderly, and people with severely
compromised immune systems.
(3) Health effects language to be used
when notice was triggered by an event
other than a coliform-positive sample,
including where required monitoring
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and analysis or flushing and
disinfection was not conducted and
where water was boarded from a
watering point that has not been
approved by FDA or was not otherwise
determined to be safe in accordance
with procedures specified in
§ 141.804(b)(6):
Because [REQUIRED MONITORING AND
ANALYSIS WAS NOT CONDUCTED],
[REQUIRED DISINFECTION AND
FLUSHING WAS NOT CONDUCTED]
[WATER WAS BOARDED FROM A
WATERING POINT NOT APPROVED BY
FDA], or [other appropriate explanation], we
cannot be sure of the quality of the drinking
water at this time. However, drinking water
contaminated with human pathogens can
cause short-term health effects, such as
diarrhea, cramps, nausea, headaches, or other
symptoms. They may pose a special health
risk for infants, young children, some of the
elderly, and people with severely
compromised immune systems. This water
may be used for hand washing, but not for
drinking, food or beverage preparation, or
teeth brushing.
rwilkins on PROD1PC63 with PROPOSALS3
§ 141.806
Reporting requirements.
(a) Reporting of the development of
the coliform sampling plan and the
operations and maintenance plan and
coliform sampling frequency.
(1) The air carrier must report to the
Administrator that they have developed
the coliform sampling plan required by
§ 141.802 that covers each existing
aircraft water system as well as report
the frequency for routine coliform
sampling identified in the coliform
sampling plan by [DATE 6 MONTHS
AFTER FINAL RULE IS PUBLISHED IN
THE Federal Register]. The air carrier
must report to the Administrator that
they have developed their operations
and maintenance plan required by
§ 141.804 by [DATE 6 MONTHS AFTER
FINAL RULE IS PUBLISHED IN THE
Federal Register];
(2) For each new aircraft meeting the
definition of an aircraft water system,
which becomes operational after
promulgation of the ADWR, the air
carrier must report to the Administrator
that they have developed the coliform
sampling plan required by § 141.802 as
well as report the frequency for routine
coliform sampling identified in the
coliform sampling plan within the first
calendar quarter of initial operation of
the aircraft. The air carrier must report
to the Administrator that they have
included the aircraft’s water system in
the operations and maintenance plan
required by § 141.804, and indicate the
routine coliform sampling frequency for
the aircraft, within the first calendar
quarter of initial operation of the
aircraft.
VerDate Aug<31>2005
18:11 Apr 08, 2008
Jkt 214001
(b) The air carrier must report the
following information to the
Administrator:
(1) A complete inventory of aircraft
that are public water systems by [DATE
6 MONTHS AFTER FINAL RULE IS
PUBLISHED IN THE Federal Register].
Inventory information includes:
(i) The unique aircraft identifier
number;
(ii) The status of the aircraft water
system as active or inactive;
(iii) The type and location of any
treatment equipment installed on the
water system; and
(iv) Whether aircraft water can be shut
off and the extent to which it can be
made inaccessible to the passengers and
crew.
(2) Changes in aircraft inventory no
later than 10 days following the
calendar month in which the change
occurred. Changes in inventory
information include:
(i) The unique identifier number for
any new aircraft, or any aircraft
removed from the carrier’s fleet;
(ii) Change in status of any aircraft
water systems (active to inactive or vice
versa); and
(iii) Type and location of any
treatment equipment added to or
removed from the water system.
(3) All sampling results no later than
10 calendar days following the
monitoring period in which the
sampling occurred. The monitoring
period is based on the monitoring
frequency identified in the coliform
sampling plan required under § 141.802.
(4) All events requiring notification to
passengers and crew and non-routine
disinfection and flushing must be
reported within 10 days of the event
triggering the notification or
disinfection and flushing requirement
(e.g., notification of positive sample
result by laboratory), including an
indication of whether required
notification was provided to passengers
and/or crew.
(5) The air carrier must report to EPA
within 10 calendar days the failure to
comply with the monitoring or
disinfection and flushing requirements
of this proposed regulation.
(c) The air carrier must provide
evidence of a self-inspection to the
Administrator within 90 days of
completion of the self-inspection
required under § 141.808(b), including
an indication that all deficiencies were
addressed in accordance with
§ 141.808(c). The air carrier must also
report to the Administrator within 90
days that any deficiencies identified
during a compliance audit conducted in
accordance with § 141.808(a) have been
addressed. If any deficiency has not
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19347
been addressed within 90 days of
identification of the deficiency, the
report must also include a description of
the deficiency, an explanation as to why
it has not yet been addressed, and a
schedule for addressing it as
expeditiously as possible.
(d) All information required to be
reported to the Administrator under this
subpart must be in an electronic format
established or approved by the
Administrator. If an air carrier is unable
to report electronically, the air carrier
may use an alternative approach that the
Administrator approves.
§ 141.807
Recordkeeping requirements.
(a) The air carrier must keep records
of bacteriological analyses for at least 5
years and must include the following
information:
(1) The date, time and place of
sampling, and the name of the person
who collected the sample;
(2) Identification of the sample as a
routine, repeat, follow-up or other
special purpose sample;
(3) Date of the analysis;
(4) Laboratory and person responsible
for performing the analysis;
(5) The analytical technique/method
used; and
(6) The results of the analysis.
(b) The air carrier must keep records
of any disinfection and flushing for at
least 5 years.
(c) The air carrier must keep records
of a self-inspection for at least 10 years.
(d) The air carrier must maintain
sampling plans and make such plans
available for review by the
Administrator upon request, including
during compliance audits.
(e) The air carrier must maintain
aircraft water system operation and
maintenance plans in accordance with
FAA requirements; and make such
plans available for review by the
Administrator upon request, including
during compliance audits.
(f) The air carrier must keep notices
to passengers and crew issued as
required by this subpart for at least 3
years after issuance.
§ 141.808
Audits and inspections.
(a) The Administrator may conduct
routine compliance audits as deemed
necessary in providing regulatory
oversight to ensure proper
implementation of the requirements in
this subpart. Compliance audits may
include, but are not be limited to:
(1) Bacteriological sampling of aircraft
water system;
(2) Reviews and audits of records as
they pertain to water system operations
and maintenance such as log entries,
disinfection and flushing procedures,
and sampling results; and
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rwilkins on PROD1PC63 with PROPOSALS3
(3) Observation of procedures
involving the handling of finished
water, watering point selection,
boarding of water, operation,
disinfection and flushing, and general
maintenance and self-inspections of
aircraft water system.
(b) Air carriers or their representatives
must perform a self-inspection of all
water system components for each
aircraft water system no less frequently
than once every 5 years.
(c) The air carrier must address any
deficiency identified during routine
compliance audits or self-inspections
within 90 days of identification of the
deficiency or where such deficiency is
identified during extended or heavy
maintenance before the aircraft is put
back into service. This includes any
deficiency in the water system’s design,
construction, operation, maintenance, or
administration, as well as any failure or
malfunction of any system component
that has the potential to cause an
unacceptable risk to health or that could
affect the reliable delivery of safe
drinking water.
VerDate Aug<31>2005
18:11 Apr 08, 2008
Jkt 214001
§ 141.809
Supplemental treatment.
(a) Any onboard drinking water
treatment units installed onboard
existing or new aircraft must be
acceptable to FAA and FDA; must meet
the applicable NSF/ANSI Standards;
and must be installed, operated, and
maintained in accordance with the
manufacturer’s plans and specifications
and FAA requirements.
(b) Water treatment and production
equipment must produce water that
meets the standards prescribed in this
part.
§ 141.810
Violations.
(a) An air carrier is in violation of this
subpart and must provide notification to
passengers and crew onboard any
aircraft it owns or operates for which
any of the following occur:
(1) It fails to disinfect and flush in
accordance with §§ 141.803 and
141.804.
(2) It fails to monitor for coliforms in
accordance with § 141.803.
(3) It fails to perform any of the
requirements in accordance with
§ 141.803(c).
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(4) It has one or more fecal coliform
positive or E. coli positive sample in
any monitoring period (routine and
repeat samples are used in this
determination).
(b) An air carrier is in violation of this
subpart when for any aircraft water
system it owns or operates any of the
following occur:
(1) It fails to provide notification to
passengers and crew in accordance with
§ 141.805.
(2) It fails to comply with the
reporting and recordkeeping
requirements of this subpart.
(3) It fails to conduct a self-inspection
or address a deficiency in accordance
with § 141.808.
(4) It fails to develop a coliform
sampling plan in accordance with
§ 141.802, or fails to have and follow an
operations and maintenance plan,
which is included in a FAA approved
or accepted program in accordance with
§ 141.804.
[FR Doc. E8–7035 Filed 4–8–08; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 73, Number 69 (Wednesday, April 9, 2008)]
[Proposed Rules]
[Pages 19320-19348]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7035]
[[Page 19319]]
-----------------------------------------------------------------------
Part III
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Part 141
National Primary Drinking Water Regulations: Drinking Water Regulations
for Aircraft Public Water Systems; Proposed Rule
Federal Register / Vol. 73, No. 69 / Wednesday, April 9, 2008 /
Proposed Rules
[[Page 19320]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 141
[EPA-HQ-OW-2005-0025; FRL-8551-3]
RIN 2040-AE84
National Primary Drinking Water Regulations: Drinking Water
Regulations for Aircraft Public Water Systems
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency is proposing to amend and
consolidate in one place the federal drinking water requirements (known
as National Primary Drinking Water Regulations or NPDWRs) for aircraft
public water systems under the Safe Drinking Water Act (SDWA). Aircraft
public water systems are subject to the requirements of SDWA and the
NPDWRs. The existing federal drinking water standards were primarily
designed to regulate water quality in stationary public water systems
and the application of these requirements to mobile water systems with
the capability of flying throughout the world has created
implementation challenges. The proposed requirements are intended to
tailor existing health-based drinking water standards to the unique
characteristics of aircraft public water systems for the enhanced
protection of public health against illnesses attributable to
microbiological contamination. This is accomplished through multiple-
barrier protection and procedural control measures. EPA believes that
the combination of these components will better protect public health
while building upon existing aircraft operations and maintenance
programs, better coordinate federal programs that regulate aircraft
water systems, and minimize disruption of aircraft flight schedules.
DATES: Comments must be received on or before July 8, 2008. Under the
Paperwork Reduction Act, comments on the information collection
provisions must be received by OMB on or before May 9, 2008.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2005-0025, by one of the following methods:
https://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: ow-docket@epa.gov.
Mail: Water Docket, Environmental Protection Agency,
Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In
addition, please mail a copy of your comments on the information
collection provisions to the Office of Information and Regulatory
Affairs, Office of Management and Budget (OMB), Attn: Desk Officer for
EPA, 725 17th St., NW., Washington, DC 20503.
Hand Delivery: EPA Docket Center, Public Reading Room, EPA
Headquarters West Building, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC 20460. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2005-
0025. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through https://
www.regulations.gov or e-mail. The https://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
Docket: All documents in the docket are listed in the https://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in https://www.regulations.gov or in hard copy at the Water Docket, EPA/
DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is (202) 566-1744, and the telephone number for the
Water Docket is (202) 566-2426.
FOR FURTHER INFORMATION CONTACT: Richard Naylor, Drinking Water
Protection Division, Office of Ground Water and Drinking Water (MC-
4606M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (202) 564-3847; e-mail address:
naylor.richard@epa.gov. For general information, contact the Safe
Drinking Water Hotline, telephone number: (800) 426-4791. The Safe
Drinking Water Hotline is open Monday through Friday, excluding legal
holidays, from 10 a.m. to 4 p.m., Eastern time.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
Entities potentially regulated by the proposed Aircraft Drinking
Water Rule include air carriers that operate aircraft public water
systems using finished surface water, finished ground water under the
direct influence of surface water (GWUDI), or finished ground water.
Regulated categories and entities include:
------------------------------------------------------------------------
Examples of regulated
Category NAICS code entities
------------------------------------------------------------------------
Scheduled passenger air 481111 Air carriers.
transportation.
Nonscheduled chartered passenger 481211 Air carriers.
air transportation.
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could potentially be regulated by this action. Other types of entities
not listed in this table could also be regulated. To determine whether
your air carrier is regulated by this action, you should carefully
examine the applicability criteria in section Sec. 141.800 of this
proposed rule. If you
[[Page 19321]]
have questions regarding the applicability of this action to a
particular entity, consult the person listed in the preceding section
entitled FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
https://www.regulations.gov or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
as CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for Preparing Your Comments. When submitting comments,
remember to:
Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
Explain why you agree or disagree, suggest alternatives,
and substitute language for your requested changes.
Describe any assumptions and provide any technical
information and/or data that you used.
If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
Provide specific examples to illustrate your concerns, and
suggest alternatives.
Explain your views as clearly as possible.
Make sure to submit your comments by the comment period
deadline identified.
C. Abbreviations Used in This Notice
ADWR: Aircraft Drinking Water Rule.
ANSI: American National Standards Institute.
AOC: Administrative Order on Consent.
ATA: Air Transport Association.
BMP: Best Management Practice.
CDC: Centers for Disease Control and Prevention.
CFR: Code of Federal Regulations.
CRMP: Comprehensive Representative Monitoring Plan.
CWS: Community Water System.
DBP: Disinfection Byproducts.
E. Coli: Escherichia coli.
EO: Executive Order.
EPA: United States Environmental Protection Agency.
FAA: United States Federal Aviation Administration.
FDA: United States Food and Drug Administration.
FR: Federal Register.
GWS: Ground Water System.
GWUDI: Ground Water Under the Direct Influence of Surface Water.
HACCP: Hazard Analysis and Critical Control Point.
HHS: Department of Health and Human Services.
HPC: Heterotrophic Plate Count.
ICC: Interstate Carrier Conveyance.
ICR: Information Collection Request.
IESWTR: Interim Enhanced Surface Water Treatment Rule.
LIMS: Laboratory Information Management System.
mL: Milliliters.
MCL: Maximum Contaminant Level.
MCLG: Maximum Contaminant Level Goal.
MDRL: Maximum Disinfectant Residual Level.
mg/L: Milligrams per Liter.
NASA: National Aeronautics and Space Administration.
NCWS: Non-Community Water System.
NDWAC: National Drinking Water Advisory Committee.
NPDWR: National Primary Drinking Water Regulation.
NSF: NSF International.
NTNCWS: Non-Transient Non-Community Water System.
NTTAA: National Technology Transfer and Advancement Act.
PWS: Public Water System.
OMB: Office of Management and Budget.
QAPP: Quality Assurance Project Plan.
RFA: Regulatory Flexibility Act.
SAB: Science Advisory Board.
SBA: Small Business Association.
SDWA: Safe Drinking Water Act.
SDWIS: Safe Drinking Water Information System.
SWTR: Surface Water Treatment Rule.
TC: Total Coliform.
TCR: Total Coliform Rule.
TNCWS: Transient Non-Community Water System.
TT: Treatment Technique.
UMRA: Unfunded Mandates Reform Act.
WHO: World Health Organization.
WSG: Water Supply Guidance.
WSP: Water Safety Plan.
D. Table of Contents
I. General Information
II. Background
A. Legal Authority
B. Purpose of the Proposed Rule
C. Scope of Proposed Rule
D. Potential Health Concerns Associated With Aircraft Water
Systems
E. Regulatory and Enforcement History
III. Proposed Rule Development
A. Stakeholder Involvement
B. Data Collection Efforts
C. Framework for Proposed Rule Development
IV. Elements of the Proposed Aircraft Drinking Water Rule
A. Sampling Requirements
B. Responses to Sample Results
C. Aircraft Water System Operation and Maintenance Plan
D. Notification Requirements to Passengers and Crew
E. Reporting Requirements
F. Recordkeeping Requirements
G. Audit and Self-Inspection Requirements
H. Supplemental Treatment
I. Violations
J. Compliance Date
V. Cost Analysis
A. Summary of Regulatory Alternatives Considered
B. National Cost Estimates
C. Comparison of Cost of Regulatory Alternatives
D. Estimated Impacts of Proposed Rule to Air Carrier Passengers
E. Non-quantified Costs and Uncertainties
VI. Relative Risk Analysis and Benefits
A. Relative Risks--Qualitative Analysis
B. Assessment of Potential Quantitative Relative Risk Analyses
C. Non-quantified Benefits
VII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Governments
G. Executive Order 13045: Protection of Children from
Environmental Health and Safety Risks
H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations or Low-Income
Populations
K. Consultations with the Science Advisory Board, National
Drinking Water Advisory Council, and the Secretary of Health and
Human Services
L. Plain Language
VIII. References
II. Background
A. Legal Authority
EPA is proposing this regulation under the authority of the Safe
Drinking Water Act (SDWA), as amended, 42 U.S.C. 300f et seq.,
primarily sections 1401, 1411, 1412 and 1450. Under SDWA, EPA
establishes minimum requirements for tap water provided to the public,
known as the National Primary Drinking Water Regulations or NPDWRs;
these standards are applicable to ``public water systems.'' SDWA
Section 1401 and EPA's regulations define a ``public water system''
(PWS) as a system for providing water for human consumption to the
public through
[[Page 19322]]
pipes or other constructed conveyances and that regularly serves an
average of a least twenty-five individuals daily, at least 60 days per
year. 40 CFR 141.2.
All public water systems are subject to the NPDWRs unless they are
excluded from regulatory requirements under SDWA Section 1411. Section
1411 excludes from regulation any public water system that receives all
its water from another regulated public water system, does not sell or
treat the water, and is not a ``carrier which conveys passengers in
interstate commerce.'' The classes of interstate carrier conveyances
(ICCs) include aircraft, trains, buses, and water vessels. As a result,
all ICCs that regularly serve water to an average of at least twenty-
five individuals daily, at least 60 days per year are public water
systems and are currently subject to existing NPDWRs regardless of
whether they treat or sell the water. Due to the unique characteristics
of aircraft water systems and demonstrated implementation challenges,
EPA has decided that a new NPDWR specifically tailored to aircraft
water systems is necessary and an Agency priority. EPA may decide to
tailor existing requirements to other classes of ICCs in the future.
B. Purpose of the Proposed Rule
The primary purpose of the proposed Aircraft Drinking Water Rule
(ADWR) is to ensure that safe and reliable drinking water is provided
to aircraft passengers and crew. This entails providing air carriers
with a feasible way to comply with SDWA and the NPDWRs. The existing
NPDWRs were designed primarily with traditional, stationary public
water systems in mind. Some of these requirements have proven difficult
to implement when applied to aircraft water systems, which are
operationally very different. For example, aircraft must maintain
rigorous operating schedules. They fly to multiple destinations
throughout the course of any given day and may board drinking water
from sources at any of these destinations. Aircraft board water from
airport watering points via temporary connections. Aircraft drinking
water safety depends on a number of factors including the quality of
the water that is boarded from these multiple sources, the care used to
board the water, and the operation and maintenance of the onboard water
system and the water transfer equipment (such as water cabinets,
trucks, carts, and hoses). These unique operational characteristics
present different challenges, which EPA is addressing in this proposal.
EPA's NPDWRs establish different requirements based on the
classification of the public water system (water system), including
whether the system is a ``community,'' ``nontransient noncommunity,''
or ``transient noncommunity'' system and whether the system uses
surface water or groundwater. Aircraft public water systems are
considered transient noncommunity water systems (TNCWS), because they
are not community water systems and they do not regularly serve at
least 25 of the same persons over six months per year (See 40 CFR
141.2). Also, aircraft are regulated as surface water systems because
they are likely to board finished drinking water from other public
water systems that use surface water in whole or in part. EPA considers
water for human consumption to include water for drinking and food
preparation as well as water for brushing teeth and hand washing (see
63 FR 41941 (August 5, 1998)). Therefore, if an aircraft has a sink in
the lavatory, then the water provided to that sink must be suitable for
human consumption.
C. Scope of Proposed Rule
The proposed ADWR only addresses aircraft regulated under SDWA.
SDWA does not regulate aircraft water systems operating outside the
U.S.; however, EPA is supporting an international effort led by the
World Health Organization (WHO) to develop international guidelines for
aircraft drinking water. The proposed ADWR applies to the onboard water
system only. EPA defers to the Food and Drug Administration (FDA) with
respect to regulating watering points such as water cabinets, carts,
trucks, and hoses from which aircraft board water. Aircraft that do not
provide water for human consumption or those with water systems that do
not regularly serve an average of at least twenty-five individuals
daily at least 60 days out of the year do not meet the definition of a
public water system; these aircraft are not regulated under the NPDWRs
or covered under the new NPDWR proposed today. An estimated 63 air
carriers and 7,327 aircraft public water systems are covered by this
proposal.
D. Potential Health Concerns Associated With Aircraft Water Systems
The proposed ADWR assumes that only finished water is boarded on
aircraft. Finished water means water that is introduced into the
distribution system of a public water system and is intended for
distribution and consumption without further treatment, except as
necessary to maintain water quality in the distribution system (e.g.,
supplemental disinfection, addition of corrosion control chemicals) (40
CFR 141.2). The assumption that only finished water is boarded on
aircraft is based on a FDA requirement that only potable water may be
provided for drinking and culinary purposes on interstate carrier
conveyances (ICCs) (21 CFR 1240.80). Aircraft public water systems that
are boarding water that is not finished water will continue to be
subject to existing NPDWRs and will not be subject to the new NPDWR
proposed today. However, even when the water boarded is finished water,
the opportunity exists for microbiological organisms to be introduced
during the act of transferring the water from the supplier truck,
cabinet, or cart to the aircraft water system, or for biofilm to
develop within the water system itself.
The proposed ADWR seeks to protect against disease-causing
microbiological contaminants or pathogens through the required
development and implementation of aircraft water system operation and
maintenance plans that include best management practices, air carrier
training requirements, and periodic sampling of the onboard drinking
water. Testing drinking water for each individual pathogen is not
practical, nor feasible. Instead, water quality and public health
professionals use total coliform bacteria as an indicator organism.
Total coliforms are a group of closely related, mostly harmless
bacteria that live in soil and water as well as in the guts of animals.
The presence of total coliforms in drinking water suggests that there
may be disease-causing agents in the water or there has been a breach,
failure, or other change in the integrity of the drinking water.
Normally, total coliforms are not harmful to human health. However, if
Escherichia coli (E. coli), a type of coliform bacteria, is present, it
can be harmful to human health. Total coliforms are inactivated, or
made harmless, by treatment or die off naturally in a manner similar to
most bacterial organisms. However, if total coliforms are found in a
water system, the system may be vulnerable to disease-causing bacteria
(i.e., pathogens), whether pathogens are actually present or not. If an
aircraft water system is not disinfected and/or flushed on a routine
basis, it may be at risk for biofilm or other bacterial growth.
Most of the bacteria in drinking water distribution systems are
associated with biofilms. There are several studies showing that
pathogenic organisms can survive longer and have greater resistance to
chlorine when occurring in biofilms than in drinking water (Lehtola et
al., 2007). Most aircraft water tanks
[[Page 19323]]
are either topped off or drained on a daily basis. However, there are
occasional situations when the water may become stagnant. Some examples
are aircraft that are occasionally taken out of service for an extended
maintenance period, or cold weather conditions that affect the ability
to drain tanks (due to concerns about the drained water freezing on the
tarmac). Additionally, aircraft with water in their tanks that
experience long layovers or overnight stays in high temperature areas
have a higher potential for rapid growth of organisms. There are no
data on outbreaks of illness caused by drinking water on aircraft. That
does not mean there is no illness because there is a high rate of
underreporting of illnesses caused by drinking water contamination.
Illness resulting from consuming contaminated aircraft water would be
no exception to this because the population onboard disperses after a
flight and even if passengers develop gastrointestinal symptoms within
hours of deplaning, they are unlikely to associate the illness with the
aircraft water or to contact the air carrier or any government agency
to report the illness. The effects of waterborne disease are usually
acute, resulting from a single or small number of exposures. Most
waterborne pathogens cause gastrointestinal illness with diarrhea,
abdominal discomfort, nausea, vomiting, or other symptoms. Most such
cases involve a sudden onset and generally are of short duration in
healthy people. Some pathogens (e.g., Giardia and Cryptosporidium),
however, may cause extended illness, lasting weeks or longer in
otherwise healthy individuals. Waterborne pathogens are particularly
harmful to sensitive populations, such as the immuno-compromised, and
can sometimes prove fatal.
E. Regulatory and Enforcement History
SDWA, including the amendments of 1986 and 1996, require EPA to
promulgate NPDWRs to prevent tap water contamination that may adversely
affect human health. As TNCWSs, aircraft are subject to certain NPDWRs
specific to this category of systems. EPA published Water Supply
Guidance 29 (WSG 29) in October 1986 to assist ICC operators, including
air carriers, in complying with these standards (USEPA 1986). WSG 29
described an alternative under which the operator of an ICC water
system could use an approved operation and maintenance program in lieu
of monitoring requirements. However, this guidance did not alter the
regulatory requirements for ICCs. Since then, EPA has determined that a
new rule specifically adapted to aircraft water systems would provide a
clearer and more implementable regulatory framework for aircraft water
systems. EPA suspended the earlier guidance in 2003 and is no longer
approving operation and maintenance programs in lieu of monitoring
under WSG 29 while the ICC program is being revised.
In 2004, EPA found all aircraft water systems to be out of
compliance with the NPDWRs. According to the air carriers, it is not
feasible for them to comply with all of the monitoring that is required
in the existing regulations. Subsequently, EPA tested 327 aircraft of
which 15 percent tested positive for total coliform. In response to
these findings, EPA embarked on a process to tailor the existing
regulations for aircraft public water systems. In the interim, EPA
placed 45 air carriers under Administrative Orders on Consent (AOC)
that will remain in effect until tailored aircraft drinking water
regulations are final. The air carrier AOCs combine sampling, best
management practices, corrective action, public notification, and
reporting and recordkeeping to ensure public health protection.
Many drinking water rules for systems using surface water or ground
water under the direct influence of surface water (GWUDI) relate to the
treatment of source water, but because aircraft board finished water,
the responsibility for treating the water is borne by the water
supplier from which aircraft obtain their water. This situation is
comparable to traditional, stationary water systems that are
consecutive systems (i.e., buy finished water from other PWSs). The
proposed ADWR adapts to aircraft water systems the applicable
requirements from the Total Coliform Rule, the suite of surface water
treatment regulations, and the Public Notification Rule, the relevant
sections of which are summarized as follows.
1. The 1989 Total Coliform Rule
The Total Coliform Rule (TCR) (USEPA, 1989) applies to all public
water systems. Because monitoring water systems for every possible
pathogenic organism is not feasible, coliform organisms are used as
indicators of possible source water and distribution system
contamination. Coliforms are easily detected in water and are used to
indicate a water system's source and distribution system vulnerability
to pathogens. In the TCR, EPA sets a Maximum Contaminant Level Goal
(MCLG) of zero for total coliforms. EPA also sets a monthly Maximum
Contaminant Level (MCL) for total coliforms and requires testing of
total coliform-positive cultures for the presence of E. coli or fecal
coliforms. E. coli and fecal coliforms indicate more immediate health
risks from sewage or fecal contamination and are used as a trigger of
acute contamination. In addition, the TCR requires sanitary surveys
(i.e., onsite review of the water source, facilities, equipment,
operation and maintenance of a PWS for the purpose of evaluating the
adequacy of such source, facilities, equipment, operation and
maintenance for producing and distributing safe drinking water). The
TCR requires sanitary surveys by the State primacy agency every 5 years
for systems that collect fewer than 5 total coliform samples per month
(those serving 4,100 people or fewer). A TNCWS using surface water
serving less than 1,000 persons daily would typically be required to
take one total coliform sample per month for routine sampling
requirements.
2. Surface Water Treatment Regulations
EPA has promulgated a suite of regulations to address
microbiological contamination of surface water. These regulations
include the Surface Water Treatment Rule (SWTR), the Interim Enhanced
Surface Water Treatment Rule (IESWTR), the Filter Backwash Recycling
Rule, and the Long Term 1 and Long Term 2 Enhanced Surface Water
Treatment Rules. These rules apply monitoring and treatment technique
requirements to protect the public from microbiological pathogens in
drinking water such as bacteria, viruses, Giardia lamblia, and
Cryptosporidium. The monitoring and treatment technique requirements
must be met prior to water entering the distribution system. Aircraft
which board only finished water are not required to provide source
water treatment or to perform monitoring of source water because these
activities are the responsibility of the public water system from which
the aircraft obtains finished water for boarding. However, the SWTR
includes provisions for maintaining a detectable distribution system
disinfectant residual and for monitoring distribution system
disinfectant residuals at the same time and location as used for total
coliform monitoring. Because disinfectant residual monitoring is
required in the distribution system, current regulations require
aircraft to perform this monitoring. A TNCWS using surface water
serving less than 1,000 persons daily would typically be required to
take one disinfectant residual sample per month. Additionally, the
IESWTR requires primary enforcement agencies to conduct sanitary
surveys for all
[[Page 19324]]
surface water and GWUDI systems regardless of size, and specifies a
frequency of every 5 years for noncommunity water systems.
3. The Public Notification Rule
Public water systems must give notice to persons served by the
water system for violations of NPDWRs and for other situations posing a
risk to public health from drinking water. The term ``NPDWR
Violations'' is used in the public notification regulations to include
violations of the MCL, Maximum Residual Disinfectant Level (MRDL),
treatment technique (TT), monitoring, and testing procedure
requirements. Public notice requirements are divided into three tiers,
which take into account the seriousness of the violation or situation
and of any potential adverse health effects that may be involved. Due
to the transient nature of the public served by TNCWSs, public notice
is typically provided through posting of the notice at locations where
the public may access drinking water from the water system.
4. Roles of the FAA and FDA in Regulating Aircraft Drinking Water
Drinking water safety on air carriers is jointly regulated by the
EPA, the Food and Drug Administration (FDA), and the Federal Aviation
Administration (FAA). EPA regulates the parent public water systems
within the United States that supply water to the airports and the
drinking water once it is onboard the aircraft. EPA is responsible for
developing and implementing the NPDWRs for all public water systems,
including public water systems on aircraft. FAA requires that air
carrier companies submit operation and maintenance programs (14 CFR
part 43, 14 CFR part 91, 14 CFR part 121) for all parts of the
aircraft, including the water system. Under the current Memorandum of
Understanding between EPA and FDA, the FDA takes the lead in regulating
culinary water and the watering points where aircraft obtain water at
the individual airports. FDA is responsible for approving all ICC
watering points (21 CFR 1240.83(a)), (1) to ensure the water supply
meets EPA's NPDWRs and (2) to ensure the methods (i.e., water transfer
process) of and facilities (e.g., water cabinets, carts, trucks,
containers, and hoses) for delivery of such water to the conveyance and
the sanitary conditions surrounding such delivery prevent the
introduction, transmission, or spread of communicable diseases.
In addition to the EPA and FDA requirements, air carriers have many
different on-going programs and practices for assessing and correcting
deficiencies and risks associated with the drinking water supply and
related safety, security and sanitation issues. Such programs and
practices may include FAA Airworthiness Standards: Transport Category
Airplanes (airworthiness maintenance and inspection program) (14 CFR
part 43, 14 CFR part 91, and 14 CFR part 121); vulnerability
assessments/security programs; FDA regulations for Interstate
Conveyance Sanitation (USFDA 2005); FDA sanitary surveys of watering
points and servicing areas; and FDA certification of aircraft
sanitation systems including potable (finished) water, sewage, and
galleys. These programs may contribute valuable information related to
the condition of the aircraft water system and water quality. EPA has
worked closely with FDA and FAA to ensure that this proposal for
aircraft water system regulation is integrated with these programs to
avoid unnecessary duplication.
III. Proposed Rule Development
A. Stakeholder Involvement
In November 2004, when EPA announced that it had initiated a
rulemaking process to develop regulations for aircraft public water
systems, the Agency committed to working collaboratively with other
federal agencies overseeing the air carrier industry, industry
representatives, and interested stakeholders to identify appropriate
requirements to ensure safe drinking water onboard aircraft. This
collaborative rule development process has allowed EPA an opportunity
to obtain information from, and hear the concerns and questions of
stakeholders who would be affected by this rule in an organized and
formal process prior to development of this proposed rule.
EPA has held three public meetings; these were held in June 2005,
January 2006, and March 2007. All three events were well-attended by
stakeholders representing a diverse group of interests including: Air
carriers, airports, flight attendants, pilots, passengers, public
health officials, environmental groups, states, public water systems,
water treatment and equipment vendors, laboratories, foreign government
agencies, and other federal agencies (e.g., FDA, FAA, and CDC).
EPA used a third-party skilled in conflict resolution to help
facilitate the process and to involve the full range of interests.
Given the number and complexity of issues associated with aircraft
drinking water, EPA began with an assessment process to identify
options to support and engage the full range of stakeholders in the
regulatory development process.
In June 2005, EPA held a public information meeting to kick-off the
rulemaking process. The meeting was followed by the development of a
stakeholder assessment report, produced by the third-party facilitator,
which is available in the docket for this rule. This report included
recommendations for a series of joint education workshops to bring
diverse stakeholders together to identify and understand the issues and
to provide input and comment on regulatory approaches and options.
The first workshop was held on January 18-19, 2006. This workshop
provided an opportunity for stakeholders to learn about aircraft water
systems and watering points, current regulations, and other information
relevant to the rulemaking. The stakeholders were encouraged to share
their initial ideas about the issues that should be addressed in
developing the proposed rule. EPA also presented for consideration by
the stakeholders a conceptual approach for the rule, which draws on the
principles of the Hazard Analysis and Critical Control Point (HACCP)
and multiple barrier approaches. This systematic approach, known as the
Water Safety Plan (WSP) approach, is described in greater detail in
section III. C. Framework for Proposed Rule Development.
The second workshop was conducted on March 28-29, 2007. At this
workshop, EPA presented for comment examples of the application of the
Water Safety Plan approach to aircraft water systems. Also, EPA
presented the preliminary monitoring data collected under the air
carrier Administrative Orders on Consent. The majority of the workshop
time was spent soliciting stakeholder input on topics critical to the
development of the ADWR including monitoring, best management
practices, public and crew notification, reporting and recordkeeping
requirements, and program oversight and verification.
B. Data Collection Efforts
In developing the ADWR proposal, EPA analyzed preliminary
monitoring results submitted under the Administrative Orders on Consent
(AOCs) from 2005-2007. In addition, to gain a better understanding of
the drinking water quality on domestic aircraft as indicated by total
coliform, E.coli/fecal coliform, and chlorine residual, EPA drew upon
the results of the following three studies: (1) A
[[Page 19325]]
voluntary monitoring study completed by the Air Transport Association
(ATA) in Fall 2003; (2) an EPA study of aircraft NPDWR compliance
completed in 2004; and (3) the Canadian Inspection Program monitoring
results completed in 2006
The EPA data summaries presented here should not be used to draw
any definitive conclusions. The AOC dataset is incomplete and therefore
considered preliminary since it represents 15 out of 45 domestic air
carriers under AOCs with EPA. The 45 domestic air carriers were placed
under AOCs to resolve non-compliance with the Safe Drinking Water Act
and the National Primary Drinking Water Regulations. The AOCs
established interim aircraft water testing and disinfection protocols.
Each of the air carriers, at a minimum, was required to implement the
following regular monitoring and disinfection protocols for its entire
fleet: Regular monitoring of aircraft water systems for coliforms and
disinfectant residuals; regular disinfection of aircraft water systems
and water transfer equipment; corrective action for total coliform-
positive sample(s); analysis of any total coliform-positive culture
media for the presence of fecal coliforms or E. coli; provision of
public notice or restriction of water service when there is a total
coliform-positive sample result; performance of a study of possible
sources of contamination that exist outside of the aircraft; and
inclusion of information regarding various aspects of its domestic and
foreign water practices.
Specific to the AOC sampling data, air carriers were required to
submit two documents for EPA approval that set the stage for monitoring
and disinfection protocols/procedures: A Comprehensive Representative
Monitoring Plan (CRMP) and a Quality Assurance Project Plan (QAPP). The
CRMP describes the air carrier's sampling and disinfection processes
and protocols for collecting samples within a 12-month period. The QAPP
describes the air carrier's Quality Assurance/Quality Control processes
to ensure good quality data and the methods for collecting and
assessing data, such as use of State- or EPA-certified laboratories and
EPA-approved analytical methods for analyzing drinking water samples.
Once the plans were approved, air carriers were required to collect and
submit their aircraft water system sampling data to EPA. As reflected
in Table III-1, air carriers followed slightly different monitoring and
disinfection protocols based on their fleet size.
Table III-1.--Monitoring and Disinfection Protocols as Required Under
the AOCs
------------------------------------------------------------------------
Air carriers Air carriers
with greater with less than
than 20 or equal to 20
aircraft aircraft
------------------------------------------------------------------------
MONITORING \1\
For each sample event, collect at [check] [check]
least one sample from a galley and
one from a lavatory for Total
Coliform (TC) and Disinfectant
Residual (total residual chlorine)...
Sample 25% of fleet quarterly......... [check] ...............
Sample all fleet quarterly............ ............... [check]
DISINFECTING AND FLUSHING \2\
Disinfect and flush each aircraft's [check] [check]
water system no less than quarterly..
Disinfect and flush watering points [check] [check]
(e.g., water trucks, carts, cabinets,
hoses) no less than monthly..........
------------------------------------------------------------------------
\1\ The air carrier was required to use State- or EPA-certified
laboratories and EPA-approved analytical methods for analyzing
drinking water samples.
\2\ If the air carrier has a pre-AOC monitoring and disinfecting program
requiring a higher frequency, the air carrier was required to continue
in accordance with their program, unless modification was requested
and approved by EPA.
As of May 31, 2007, of the 45 air carriers under AOCs, EPA has
analyzed preliminary drinking water sampling data from 15 air carriers
consisting of 2,316 aircraft out of an estimated total fleet size of
5,558. The total number of samples (routine and repeat) was 12,099. Of
these samples, 3.1 percent (378 samples) were total coliform-positive.
Of the 378 total coliform-positive samples, 2.4 percent (9 samples)
were E. coli/fecal coliform-positive. Of a total of 7,489 routine
chlorine residual samples taken, 26.1 percent (1,957) resulted in a
non-detect. However, in relating the preliminary AOC sampling data to
other aircraft water quality studies only the routine samples were
used. Repeat samples were not used because they by nature have a higher
probability of being total coliform-positive since repeats are taken
after a routine sample is total coliform-positive. In addition, the
other studies did not take repeat samples, therefore, the routine
samples are most analogous to the data collected under the other
studies.
Therefore, in determining an estimated baseline of domestic air
carrier drinking water quality the following was observed in the
preliminary AOC data: Out of 7,812 routine samples, 2.8 percent (222
samples) were total coliform-positive. Of the 222 total coliform-
positive samples, 2.3 percent (5 samples) were E. coli/fecal coliform-
positive. Of the 3,952 routine chlorine residual samples taken, 21.5
percent (848) resulted in a non-detect.
Under a voluntary study coordinated with EPA, ATA sampled 265
passenger aircraft operated by eight ATA-member U.S. air carriers. As
noted by ATA, these eight air carriers represent the majority of the
U.S. commercial passenger fleet, and serve both domestic and
international routes. The aircraft were randomly selected and samples
were generally collected from the galley, except in some cases where
the galley faucets were equipped with filters, efforts were made to
collect residual disinfectant samples from the lavatory. The samples
were analyzed for total coliform (and in the case of a total coliform-
positive result, the sample was tested for E. coli/fecal coliform),
total residual chlorine, turbidity, total nitrate, and nitrite.
Regarding microbiological testing, of the 265 aircraft sampled, 2.6
percent (7 aircraft) were total coliform-positive; there were no fecal
coliform or E. coli-positive samples. Water samples from forty-one
percent of the aircraft had non-detectable chlorine residuals (ATA
2003).
In the 2004 EPA NPDWR Compliance study, 327 passenger aircraft
belonging to ATA and non-ATA members were randomly tested at 12 U.S.
airports that served both domestic and international routes. EPA
analyzed the drinking water samples from galleys and lavatories for
total coliform (and in the case of a total coliform-positive result,
the sample was tested for E. coli/fecal coliform), total
[[Page 19326]]
residual chlorine, heterotrophic plate count, total nitrate, and
nitrite. In regard to microbiological presence, 15 percent (49/327) of
the aircraft tested positive for total coliform, and 4.1 percent (2/49
aircraft) of these total coliform positive aircraft also tested
positive for E. coli/fecal coliform. Twenty-one percent (69/327) of the
aircraft tested had a non-detectable chlorine residual.
Under the Canadian Inspection Program, Health Canada randomly
inspected 431 aircraft for microbiological presence in drinking water.
Of the 431 aircraft tested, 15.1 percent (65 aircraft) were total
coliform-positive, and 7.7 percent (5/65 aircraft) of these total
coliform positive aircraft were also E. coli positive. Most of the
contamination (4 samples) was found in water from the lavatory faucets.
The Canadian study did not test for chlorine residual (Canada 2007a and
2007b).
It is important to note that the intended purpose and use of the
preliminary AOC and the other aircraft sampling results were to protect
public health by providing an understanding of the quality of airline
drinking water. Although they were not collected to drive the ADWR
rulemaking process, these datasets provide important information for an
estimated baseline of aircraft drinking water quality for total
coliform, E. coli/fecal coliform, and residual chlorine.
Although it is difficult to complete a one-to-one comparison of the
sampling results among the studies, observed differences may be
attributed to several factors. For instance, best management practices
and protocols (such as systematic sampling, disinfecting, and flushing
procedures) established under the AOCs may have played a part in the
varying results. These systematic protocols may have created a greater
chance of consistency and effectiveness among the air carriers in
implementing the operational and maintenance procedures of an aircraft
water system. In addition, these findings suggest that best management
practices are important for public health protection.
EPA will continue to collect and analyze the aircraft sampling data
for the 45 air carriers under the AOCs. EPA will use the data to
improve the Agency's understanding of aircraft drinking water quality
relevant to microbiological controls. A summary of the final results
will be released along with available sampling data from the 45 air
carriers under AOCs. Docket ID No. EPA-HQ-OW-2005-0025.
C. Framework for Proposed Rule Development
For today's proposal, EPA has considered both the existing NPDWRs
applicable to aircraft water systems--the Total Coliform Rule, the
Surface Water Treatment Regulations and the Public Notification Rule--
and a systematic risk management approach used for food and water
safety by other agencies, which EPA believes can be particularly
effective when dealing with mobile sources of drinking water. The
resulting proposed rule is intended to consolidate the three existing
NPDWRs into one new NPDWR and modify them, based on the Water Safety
Plan approach described as follows, so that the drinking water
standards can be more effectively implemented for aircraft water
systems and better integrated with FDA and FAA programs and
requirements.
1. HACCP and Water Safety Plan Approaches
EPA believes that an effective means of assuring safe drinking
water onboard aircraft is through the application of a systematic risk
management approach referred to as the Water Safety Plan (WSP)
approach. The Water Safety Plan concept was developed by the World
Health Organization (WHO) as part of the 3rd edition of its drinking
water guidelines (WHO 2004). It is based on the Hazard Analysis and
Critical Control Point (HACCP) concepts and the multiple barrier
approach to protecting public health.
The basic HACCP concepts were originally developed in 1959 by the
Pillsbury Company with cooperation and participation from the National
Aeronautics and Space Administration (NASA), the Natick Laboratories of
the U.S. Army, and the U.S. Air Force Space Laboratory Project Group.
The purpose was to ensure food and beverage safety from microbiological
hazards for the first NASA manned space missions. Since the 1980s, the
HACCP system has been adopted by food and beverage industries world-
wide, where it forms an important part of their ``food safety plans.''
For example, the FDA has adopted the HACCP system as an effective
approach for its food safety program. FDA utilized the HACCP approach
in the final rules for the seafood and juice industries. HACCP
guidelines developed by WHO, known as Codex Alimentarius, have been
adopted internationally as the primary recognized food safety
methodology for risk management. The current HACCP guideline (WHO,
1997) was developed by the Codex Alimentarius Commission.
In the multiple barrier approach, technical and managerial barriers
help prevent contamination at the source, treatment, distribution, and
tap to provide a safe supply of drinking water for consumers. The
barriers include risk prevention, risk management, monitoring and
compliance, and individual action. As an enhancement of the HACCP
approach, the Water Safety Plan approach identifies control measures
not only at critical control points, as is done for HACCP, but also at
the point of contamination where the hazardous event occurs as well as
downstream of the potential contamination point. The intent is to
enable the effect of the multiple barriers to be assessed together
(Davison et al., 2005). The Water Safety Plan approach continues to
evolve as the water industry gains experience by developing and
implementing Water Safety Plans.
2. Proposed Rule Approach
The proposed approach for this rulemaking effort includes elements
of the HACCP approach and WHO's Water Safety Plan approach and builds
on the foundation of the controls established under the existing NPDWRs
applicable to aircraft water systems. This proposed regulation does not
require each air carrier to develop its own Water Safety Plan (WSP).
Instead, the WSP approach was used to outline the priority hazards and
the control measures that could be implemented to control these hazards
in the entire aircraft water supply and transfer chain. By looking
holistically at the entire process, EPA ensured a collaborative working
relationship with other federal agencies overseeing the air carrier
industry. This holistic approach will minimize duplication of effort
and regulation by multiple federal agencies over the same segment of
the process. It also helps minimize concerns of over-regulation in one
segment of a process to address an issue that could be more effectively
handled in another segment of the process. Once the hazards and
potential control measures were identified, EPA could then focus on the
specific area of its jurisdiction, the onboard water system.
3. Identified Hazard Events and Potential Control Measures
The following are examples of the primary hazard events and
potential control measures for aircraft water systems identified
through the WSP approach.
Water to be boarded does not meet NPDWRs applicable to
TNCWSs. The potential control measure is to prevent boarding of water,
if operational needs (e.g., flushing of toilets) can be met
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without boarding additional water. If water must be boarded,
appropriate control measures are to: Restrict public access, provide
public notification, including posting notices at lavatory and galley
taps stating that the water is not for consumption; provide bottled
water for coffee making and drinking; providing antiseptic alcohol-
based hand gels or wipes for handwashing; disinfecting and flushing the
aircraft water system as soon as possible; and demonstrating
satisfactory aircraft water quality through follow-up sampling before
resumption of unrestricted public access to the aircraft water system.
Air carrier or aircraft crew is notified that water
already boarded does not meet NPDWRs applicable to TNCWSs. The
potential control measures are to: Restrict public access, provide
public notification, including posting notices at lavatory and galley
taps stating that the water is not for consumption; providing bottled
water for coffee making and drinking; providing antiseptic alcohol-
based hand gels or wipes for handwashing; disinfecting and flushing the
aircraft water system as soon as possible; and demonstrating
satisfactory aircraft water quality through follow-up sampling before
resumption of unrestricted public access to the aircraft water system.
Use of a watering point, including transfer and delivery
systems, not approved by FDA. The potential control measure is for the
air carrier to obtain approval from FDA for new watering points or when
changing watering points.
Contamination or cross contamination due to unsanitary
practices. The potential control measures are to: Clean and disinfect
hoses, transfer pumps, water trucks, and other equipment; develop
written standard operating procedures (SOPs) and provide training for
sanitary water transfer practices and aircraft cleaning; conduct total
coliform monitoring; restrict public access, provide public
notification, including posting notices at lavatory and galley taps
stating that the water is not for consumption; providing bottled water
for coffee making and drinking; providing antiseptic alcohol-based hand
gels or wipes for handwashing; disinfecting and flushing the aircraft
water system as soon as possible; and demonstrating satisfactory
aircraft water quality through follow-up sampling before resumption of
unrestricted public access to the aircraft water system; and conducting
audits or inspections.
Backflow from unprotected cross connection, failure of
backflow prevention devices, or cross contamination from water line
break. The potential control measures are to: Identify possible cross
connections and install backflow prevention devices as warranted;
repair failed backflow prevention devices; repair water line breaks;
disinfect and flush the aircraft water system as soon as possible; and
resample aircraft water quality before returning to service.
Improperly designed aircraft water system. The potential
control measure is to obtain FDA review and approval of plans and
specifications (Certificate of Sanitary Construction) for new aircraft
water systems.
Bacterial growth in aircraft water system. The potential
control measures are to: Conduct routine total coliform monitoring; and
routinely disinfect and flush the aircraft water system.
IV. Elements of the Proposed Aircraft Drinking Water Rule
The following sections describe the elements of the aircraft
drinking water rule as proposed by EPA. The proposed rule has
significant operational advantages over the other more prescriptive
alternatives, which are described in section V. EPA specifically
designed the proposed rule to allow air carriers to follow the
manufacturer recommendations for disinfecting and flushing aircraft
water systems, instead of prescribing the frequency, chemical type and
concentration to be used. Another advantage of the proposed rule over
the approaches described in the alternatives is that by utilizing the
manufacturer recommendations for disinfection and flushing, the rule
requirements will automatically evolve (another stakeholder
recommendation) with technological improvements in aircraft water tank
lining and piping materials and as new more effective disinfectants are
developed.
EPA requests comment on all aspects of this rule. Please note,
however, that EPA is not requesting, and will not consider, comments on
any aspect of the TCR, surface water treatment regulations, Public
Notification Rule or any other NPDWR other than as applied to aircraft
water systems in this proposal. In addition to rule requirements, EPA
identifies specific requests for comment on subject matters pertaining
to the proposed rule.
A. Sampling Requirements
1. Coliform Sampling Plan
As discussed above, the existing TCR requires testing for total
coliforms in water systems. Under this proposal, EPA is requiring each
air carrier to develop a coliform sampling plan (within six months
after the final rule is published in the Federal Register) for each
aircraft that identifies the following: (1) Coliform sample collection
procedures, (2) sample tap location(s) representative of the aircraft
water system, including both galley and lavatory taps when available,
(3) frequency and number of routine coliform samples to be collected
(4) frequency of routine disinfection and flushing as specified in the
operation and maintenance plan, and (5) procedures for communicating
sample results promptly so that any required actions including repeat
and follow-up sampling, corrective action, and notification of
passengers and crew may be conducted in a timely manner. The
development of a sampling plan will assist the air carrier in tracking
regulatory requirements, identifying coliform detection trends, if any
exist, and in maintaining compliance.
2. Coliform Sampling Requirements
In keeping with the current TCR, air carriers need only determine
the presence or absence of total coliforms in water samples collected
from aircraft water systems; a determination of total coliform density
would not be required. EPA believes this aids in making the sampling
process more efficient and avoids unnecessary analysis. In addition,
this proposed rule specifies that only analytical methodologies
approved by EPA are to be used for sampling. For routine monitoring,
each aircraft water system water sample must be 100 mL. One sample must
be taken from a lavatory and one sample from a galley; each must be
analyzed for total coliform. EPA believes the selection of sample taps
from both the lavatory and the galley is necessary since tap options
throughout these types of water systems is limited. If only one water
tap is located in the aircraft water system due to aircraft model type
and construction, then a single tap may be used to collect two separate
100 mL samples.
Routine coliform sampling should be representative of the general
conditions of the aircraft water system. To ensure that results of
routine samples are not inadvertently skewed by sampling too soon after
a disinfection event, routine coliform samples must not be collected
within 72 hours after completing disinfection and flushing procedures.
EPA believes that spacing routine samples evenly across monitoring
periods will help. This is necessary in order to capture a
representative sample from normal aircraft water system operations.
Additional, or special, coliform sampling is always encouraged and
recommended by EPA.
[[Page 19328]]
Routine coliform monitoring frequencies are as follows:
If the air carrier disinfects and flushes the entire water
system at least quarterly, then coliform monitoring must occur at least
annually;
If the air carrier disinfects and flushes the entire water
system one to three times per year, then coliform monitoring must occur
at least quarterly; or
If the air carrier disinfects and flushes the entire water
system less than once per year, then coliform monitoring must occur at
least monthly.
It should be noted that this is the first NPDWR that requires
disinfection and flushing as a required extra barrier for the
protection of public health. EPA understands that most of the air
carrier maintenance programs employ water system disinfection and
flushing; however, EPA believes that making three sampling frequency
options available to air carriers for the aircraft water systems that
they operate provides the flexibility to meet the evolving needs of the
industry while still providing adequate barriers of protection.
This proposal uses calendar-based monitoring and reporting
frequencies. This basis is also consistent with EPA's current methods
of oversight and is compatible with the Agency's current data systems.
EPA is aware that the air carrier industry typically schedules
maintenance or other activities based on aircraft flight hours or
flight days. Scheduling activities on a calendar basis could lead to
incompatibility and challenges in creating regular maintenance
schedules. On the other hand, if an aircraft is not in frequent
operation, basing aircraft water system activities on a flight time
basis could lead to an extended calendar period before any actions are
taken, which would not be protective of public health. EPA requests
comment on whether the proposed calendar basis could reasonably be
integrated with the air carrier industry's flight time basis, or if
not, how the Agency should transpose the proposed requirements to an
equivalent standard on a flight time basis.
B. Response to Sampling Results
1. All routine coliform samples are negative. If all routine
samples are total coliform-negative in a monitoring period, then the
air carrier must continue to maintain its routine monitoring for
coliform based on the frequency required under the rule.
2. The sample yields a positive result for total coliform. If any
routine or repeat coliform sample is total coliform-positive, then that
total coliform-positive culture medium must be analyzed to determine if
fecal coliforms or E. coli are present.
3. One of two routine water samples test positive for total
coliform, but negative for E. coli or fecal coliforms. In response to a
single total coliform-positive sample result that is fecal/E. coli
negative, the air carrier must perform at least one of the following:
Disinfection and flushing no later than 72 hours after the
laboratory notifies the air carrier of the positive result. Follow-up
samples must be collected after disinfection and flushing is performed
to ensure the effectiveness of the process. A complete set of post
disinfection and flushing follow-up sample results (i.e., one from the
lavatories and one from the galleys) must be total coliform-negative
before the air carrier provides water from the aircraft water system to
passengers and crew and returns to the routine monitoring frequency for
coliform; or
Repeat Sampling. Collect four 100 mL repeat samples within
24 hours of being notified of the positive result. Repeat samples must
be collected and analyzed from four taps within the aircraft water
system: the tap which resulted in the total coliform-positive sample,
one other lavatory tap, one other galley tap, and one other tap; if
less than four taps exist, then a total of four 100 mL samples must be
collected and analyzed from the available taps within the aircraft
water system. If no repeat sample is total coliform-positive, the
system returns to its routine monitoring schedule and no further
follow-up is required.
4. Any sample test result is fecal coliform positive or E. coli-
positive. Since fecal coliform or E. coli bacteria indicate the
potential presence of contaminants that can cause acute health risks,
EPA believes it is necessary to take immediate corrective action for
the protection of public health. The aircraft water system is not a
traditional water system and the air carrier must therefore take
additional measures to prevent any disease or illness. If any routine
or repeat sample is fecal coliform-positive or E. coli-positive, then
the air carrier must perform all of the following:
Restrict public access to the aircraft water system which
includes providing notification to passengers and crew as soon as
possible but no later than 24 hours after being notified of the
positive result.
Conduct disinfection and flushing prior to resumption of
unrestricted public access to the aircraft water system or no later
than 72 hours if the aircraft water system cannot be physically
disconnected/shut off to the crew and passengers.
Collect follow-up samples after disinfection and flushing
is performed to ensure the effectiveness of the process. A complete set
of post disinfection and flushing follow-up sample results must be
total coliform-negative before the air carrier provides water from the
aircraft water system to passengers