[Federal Register Volume 73, Number 69 (Wednesday, April 9, 2008)]
[Proposed Rules]
[Pages 19320-19348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-7035]
[[Page 19319]]
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Part III
Environmental Protection Agency
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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]]
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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.
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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:
http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: [email protected].
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
http://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 http://www.regulations.gov or e-mail. The http://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 http://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 http://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:
[email protected]. 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:
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Examples of regulated
Category NAICS code entities
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Scheduled passenger air 481111 Air carriers.
transportation.
Nonscheduled chartered passenger 481211 Air carriers.
air transportation.
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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
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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.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
http://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
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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 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
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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 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
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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
[[Page 19327]]
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 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 coliform-negative 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 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. 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 follow-up 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.
[[Page 19329]]
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 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. 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 follow-up 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 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 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 alcohol-based 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, teeth-brushing, 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 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
[[Page 19330]]
other situations that may augment concern regarding bacterial growth.
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.
5. Option for Repeat Sampling
Under this proposal, an aircraft water system that has one total
coliform-positive 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 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
[[Page 19331]]
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 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 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 coliform-positive 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
[[Page 19332]]
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 coliform-negative. 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 non-English speaking population served, including where
appropriate an easily-recognizable symbol for non-potable water.
When public access to the aircraft water system is
restricted the air carrier must provide the following public
notification:
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:
[cir] 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;
[cir] A description of the violation or situation triggering the
notice, including the contaminant(s) of concern;
[cir] When the violation or situation occurred;
[cir] Any potential adverse health effects from the violation or
situation;
[cir] The population at risk, including sensitive subpopulations
particularly vulnerable if exposed to the contaminant in the drinking
water;
[cir] What the air carrier is doing to correct the violation or
situation; and
[cir] 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:
[cir] A clear statement that the water is non-potable and should
not be used for drinking, food or beverage preparation, or teeth
brushing;
[cir] 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;
[cir] 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;
[cir] Any potential adverse health effects from exposure to
waterborne pathogens that might be in the water;
[cir] The population at risk, including sensitive subpopulations
particularly vulnerable if exposed to the contaminant in the drinking
water; and
[cir] 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 coliform-positive 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
[[Page 19333]]
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.
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 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 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 web-based 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
[[Page 19334]]
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
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 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
[[Page 19335]]
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.
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 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 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
[[Page 19336]]
corrective action disinfection and flushing procedures, including
follow-up 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 self-
inspections.
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 Total
-----------------------3%----------------------------------------------------------------------
7%
-----------------------------------------------------------------------------------------------
Implementation.......................................... $0.002 $0.01 $0.01 $0.003 $0.01 $0.01
Annual Administration................................... .............. 0.25 0.25 .............. 0.25 0.25
Sampling Plan........................................... 0.002 0.001 0.003 0.003 0.001 0.004
O&M Plan................................................ 0.01 0.000 0.01 0.02 0.000 0.02
Coliform Monitoring..................................... 5.32 0.04 5.36 5.39 0.04 5.43
Routine Disinfection and Flushing....................... 2.37 .............. 2.37 2.40 .............. 2.40
Corrective Action Disinfection and Flushing............. 0.14 .............. 0.14 0.14 .............. 0.14
Compliance Audit........................................ 0.01 0.01 0.02 0.01 0.01 0.02
-----------------------------------------------------------------------------------------------
[[Page 19337]]
Total............................................... 7.86 0.30 8.16 7.96 0.31 8.27
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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-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 Alt 2 Alt 3 Alt 4
-------------------3%----------------------------------------------------------
7%
-------------------------------------------------------------------------------
Implementation.................. 0.01 0.01 0.01 0.01 0.01 0.01 0.01 0.01
Annual Administration........... 0.25 0.25 0.25 0.25 0.25 0.25 0.25 0.25
Monitoring Plan................. 0.003 0.003 0.001 0.003 0.004 0.004 0.002 0.004
O&M Plan........................ ........ ........ 0.01 0.01 ........ ........ 0.01 0.02
Coliform Monitoring............. 26.53 1.68 2.29 5.36 26.85 1.70 2.31 5.43
Disinfectant Residual Monitoring 3.65 0.75 ........ ........ 3.69 0.76 ........ ........
Routine Disinfection and ........ 4.98 3.39 2.37 ........ 5.04 3.43 2.40
Flushing.......................
Corrective Action Disinfection ........ 0.05 0.05 0.14 ........ 0.05 0.05 0.14
and Flushing...................
Sanitary Survey/Compliance Audit 0.72 ........ ........ 0.02 0.73 ........ ........ 0.02
Turbidity Monitoring............ ........ ........ 15.01 ........ ........ ........ 15.19 ........
-------------------------------------------------------------------------------
Total....................... 31.16 7.72 21.00 8.16 31.54 7.82 21.26 8.27
----------------------------------------------------------------------------------------------------------------
[[Page 19338]]
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 Disinfectant Corrective Total number
Rule Alternative monitoring residual Total Routine action of
coliform monitoring number of disinfection disinfection disinfection
sampling sampling sampling and flushing and flushing and flushing
events/year events/year events/year events/year events/year events/year
A B C = A + B D E F = D + E
---------------------------------------------------------------------------------
Alt 1......................... 46,248 46,248 92,496 ............ ............ ............
Alt 2......................... 7,708 7,708 15,416 29,308 454 29,762
Alt 3......................... 7,708 ............ 7,708 29,308 454 29,762
Alt 4......................... 26,593 ............ 26,593 20,516 1,175 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.
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
self-inspection 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 self-
inspections, which involve a thorough review and inspection of an
aircraft water system, is already captured under 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
[[Page 19339]]
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.
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 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 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
[[Page 19340]]
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.
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 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-for-profit 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
[[Page 19341]]
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: 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 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.
[[Page 19342]]
F. Executive Order 13175: Consultation and Coordination With Indian
Governments
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.
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 enhance more effective protection of public health,
including the health of children who are aircraft passengers.
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.
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 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
[[Page 19343]]
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?
VIII. References
ATA (Air Transport Association of America, Inc.) 2003. Air Transport
Association: Aircraft Drinking Water Sampling Program, Final Report:
December 31, 2003. http://www.airlines.org.
Canada. 2007a. Health Canada. Healthy Living. Aircraft Inspection
Program--Frequently Asked Questions. http://www.hc-sc.gc.ca/hl-vs/travel-voyage/general/inspection/airplane-aeronefs_e.html.
Canada. 2007b. Health Canada. Healthy Living. Advisory. Health
Canada cautions air travelers with compromised immune systems
regarding water quality on aircraft. http://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. http://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 Water-Associated Biofilms Grown under
High-Shear Turbulent Flow. Applied and 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. http://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.
Subpart X --Aircraft Drinking Water Rule
Sec. 141.800 Applicability and compliance date.
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].
Sec. 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
[[Page 19344]]
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.
Sec. 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 Sec. 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 Sec. 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 Sec. 141.804.
Sec. 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 invalidation of a total coliform
sample result can only be made by the Administrator in accordance with
Sec. 141.21(c)(1)(i), (ii), or (iii) or by the State or EPA certified
laboratory in accordance with Sec. 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 Sec. 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 Sec. 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 Coliform-Positive 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 Sec. 141.804,
initiate disinfection and flushing of the system no later than 72 hours
after the 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
coliform-positive, 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. coli-positive, 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 Sec. 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 Sec. 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
coliform-positive 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 Sec. 141.804
prior to resumption of unrestricted public access to the aircraft water
system, or no later
[[Page 19345]]
than 72 hours if the aircraft water system cannot be physically
disconnected/shut off to the crew and passengers as stated in Sec.
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 Sec. 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 follow-up 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 re-disinfect and
flush the aircraft water system in accordance with Sec. 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 Sec. 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
(2) Conduct disinfection and flushing within 72 hours in accordance
with Sec. 141.804(b)(2).
(3) Collect follow-up samples pursuant to paragraph (d) of this
section.
(f) Failure to Collect Repeat or Follow-up 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 Sec. 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 Sec. 141.804(b)(8); and
(3) Collect follow-up samples pursuant to paragraph (d) of this
section.
Sec. 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.
(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 Sec.
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 Self-inspections 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 Sec. 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 Sec.
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 Sec. 141.803(d) of this
section.
(7) Coliform Sampling Plan. The air carrier must include the
coliform
[[Page 19346]]
sampling plan prepared in accordance with Sec. 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 Sec. 141.804 within the first
calendar quarter of initial operation of the aircraft.
Sec. 141.805 Notification of passengers and crew.
(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 Sec. 141.803(c)(3) or (4);
(2) There has been a failure to collect required samples, in
accordance with Sec. 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 Sec. 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;
(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 non-English 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 Sec. 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
(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 Sec. 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 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.
(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
[[Page 19347]]
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 Sec. 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.
Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 141.804, and
indicate the routine coliform sampling frequency for the aircraft,
within the first calendar quarter of initial operation of the aircraft.
(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 Sec. 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 Sec. 141.808(b), including an indication that all
deficiencies were addressed in accordance with Sec. 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 Sec. 141.808(a) have been addressed. If any deficiency
has not 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.
Sec. 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.
Sec. 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
[[Page 19348]]
(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.
Sec. 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.
Sec. 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 Sec. Sec.
141.803 and 141.804.
(2) It fails to monitor for coliforms in accordance with Sec.
141.803.
(3) It fails to perform any of the requirements in accordance with
Sec. 141.803(c).
(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 Sec. 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 Sec. 141.808.
(4) It fails to develop a coliform sampling plan in accordance with
Sec. 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 Sec. 141.804.
[FR Doc. E8-7035 Filed 4-8-08; 8:45 am]
BILLING CODE 6560-50-P