National Primary Drinking Water Regulations: Drinking Water Regulations for Aircraft Public Water Systems, 53590-53625 [E9-24552]
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Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Rules and Regulations
against illnesses attributable to
microbiological contamination. EPA
believes that this approach 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 disruptions of aircraft flight
schedules.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 141
[EPA–HQ–OW–2005–0025; FRL–8967–9]
RIN 2040–AE84
National Primary Drinking Water
Regulations: Drinking Water
Regulations for Aircraft Public Water
Systems
DATES: This rule is effective November
18, 2009. For judicial review purposes,
this final rule is promulgated as of
October 19, 2009.
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OW–2005–0025. All
documents in the docket are listed on
the https://www.regulations.gov Web
site. Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically through
https://www.regulations.gov or in hard
copy at the Water Docket, EPA/DC, EPA
West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
ADDRESSES:
The Environmental Protection
Agency is establishing Federal drinking
water requirements (known as national
primary drinking water regulations or
NPDWRs) for aircraft public water
systems (hereafter, aircraft water
systems) under the Safe Drinking Water
Act (SDWA). 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. This final rule’s
requirements are intended to tailor
existing health-based drinking water
standards to the unique characteristics
of aircraft water systems for the
enhanced protection of public health
SUMMARY:
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 or Cindy Y. Mack,
Drinking Water Protection Division,
Office of Ground Water and Drinking
Water (MC–4606M), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460;
telephone numbers: Richard Naylor
(202) 564–3847 or Cindy Y. Mack (202)
564–6280; e-mail addresses:
naylor.richard@epa.gov or mack.cindyy@epa.gov. For general information,
contact the Safe Drinking Water Hotline,
telephone number: (800) 426–4791. The
Safe Drinking Water Hotline is open
Monday through Friday, excluding legal
holidays, from 10 a.m. to 4 p.m., Eastern
time.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
Entities potentially regulated by the
Aircraft Drinking Water Rule (ADWR)
include air carriers that operate aircraft
water systems using finished surface
water, finished ground water under the
direct influence of surface water
(GWUDI), or finished ground water.
Regulated categories and entities
include:
Category
NAICS code
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Scheduled passenger air transportation .................................................................................................
Nonscheduled chartered passenger air transportation ...........................................................................
This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
regulated by this action. This table lists
the types of entities that EPA is now
aware could potentially be regulated by
this action. Other types of entities not
listed in this table could also be
regulated. To determine whether your
air carrier is regulated by this action,
you should carefully examine the
applicability criteria in § 141.800 of this
final rule. If you 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. Abbreviations Used in This Notice
ADWR: Aircraft Drinking Water Rule
ANSI: American National Standards Institute
AOCs: Administrative Orders on Consent
ATA: Air Transport Association
BMP: best management practice
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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
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481111
481211
Examples of regulated
entities
Air carriers.
Air carriers.
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
NAICS: North American Industrial
Classification System
NCWS: non-community water system
NDWAC: National Drinking Water Advisory
Committee
NPDWR: national primary drinking water
regulation
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 Administration
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SDWA: Safe Drinking Water Act
SDWIS: Safe Drinking Water Information
System
SWTR: Surface Water Treatment Rule
TC: total coliform
TCR: Total Coliform Rule
TCRDSAC: Total Coliform Rule/Distribution
System Advisory Committee
TNCWS: transient non-community water
system
TT: treatment technique
UMRA: Unfunded Mandates Reform Act
US: United States
UV: Ultra Violet
WHO: World Health Organization
WSG: Water Supply Guidance
WSP: Water Safety Plan
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C. Table of Contents
I. General Information
A. Does this Action Apply to Me?
B. Abbreviations Used in This Document
II. Background
A. Legal Authority
B. Purpose of the Rule
C. Scope and Applicability of Rule
D. Regulatory and Enforcement History
III. Final Rule Development
A. Stakeholder Involvement
B. Aircraft Drinking Water Quality
IV. Elements of the Final Aircraft Drinking
Water Rule
A. Definitions (§ 141.801)
B. Sampling Requirements (§§ 141.802 and
141.803)
C. Responses to Sample Results (§ 141.803)
D. Restricted Access to the Water System
E. Response to Proposed Rule Requests for
Comment
F. Aircraft Water System Operation and
Maintenance Plan (§ 141.804)
G. Notification Requirements to Passengers
and Crew (§ 141.805)
H. Reporting Requirements (§ 141.806)
I. Recordkeeping Requirements (§ 141.807)
J. Audit and Self-Inspection Requirements
(§ 141.808)
K. Violations (§ 141.810)
L. Compliance Date
V. Cost Analysis
A. National Cost Estimates
B. Estimated Impacts of Final ADWR to Air
Carrier Passengers
C. Comparison of Costs From Proposed
Rule to Final Rule
D. Non-quantified Costs and Uncertainties
VI. Benefits Analysis
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 Tribal
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
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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
M. Congressional Review Act
N. Analysis of the Likely Effect of
Compliance With the ADWR on the
Technical, Financial, and Managerial
Capacity of Public Water Systems
VIII. References
II. Background
A. Legal Authority
EPA is finalizing 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
pipes or other constructed conveyances
and that regularly serves an average of
at 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 of its
water from another regulated public
water system, does not sell or treat the
water, and is not a ‘‘carrier which
conveys passengers in interstate
commerce.’’ The classes of interstate
carrier conveyances (ICCs) include
aircraft, trains, buses, and water vessels.
As a result, all ICCs that regularly serve
water to an average of at least twentyfive individuals daily, at least 60 days
per year are public water systems and
are currently subject to existing
NPDWRs regardless of whether they
treat or sell the water.
EPA’s NPDWRs establish different
requirements based on the classification
of the public water system (water
system), including whether the system
is a ‘‘community,’’ ‘‘non-transient noncommunity,’’ or ‘‘transient noncommunity’’ system, and whether the
system uses surface water or
groundwater. Aircraft water systems are
considered transient non-community
water systems (TNCWS) because they
are not community water systems and
they do not regularly serve an average
of at least twenty-five of the same
persons over six months per year (see 40
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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.
B. Purpose of the Rule
The primary purpose of the 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 and effective
way to comply with SDWA and the
NPDWRs. Due to the unique
characteristics of aircraft water systems
and demonstrated implementation
challenges, EPA developed a new
NPDWR specifically tailored to aircraft
water systems, the Aircraft Drinking
Water Rule (ADWR).
The ADWR has been developed 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.
C. Scope and Applicability of Rule
This final rule 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 final rule
applies to the onboard water system
only. EPA defers to the United States
Food and Drug Administration (FDA)
with respect to regulating watering
points such as water cabinets, carts,
trucks, and hoses from which aircraft
board water.
EPA assumes that only finished water
is boarded for human consumption 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
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based on an FDA requirement that only
potable water may be provided for
drinking and culinary purposes on
interstate carrier conveyances (ICCs) (21
CFR 1240.80). However, aircraft water
systems that are boarding water that is
not finished water will continue to be
subject to existing NPDWRs.
FDA requirements cover 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. FDA
requirements for watering points do not
entail the individual certification of
every potential source, method, facility,
or system; however, ICC selected
watering points must be in accordance
with FDA requirements (21 CFR part
1240, subpart E).
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
regulated under this final ADWR. EPA
also does not regulate under SDWA
water systems that only serve water
outside the U.S. On the April 9, 2008,
proposed ADWR, EPA received public
comment as to the applicability of the
ADWR to aircraft water systems based
on ownership (e.g., foreign carrier, U.S.
military). The final rule clarifies that the
applicability of the ADWR is not based
on ownership, but on the determination
as to whether the aircraft water system
is operating within the U.S., meets the
definition of a public water system
(PWS) under SDWA section 1401, and
is not excluded from regulation under
SDWA section 1411. An aircraft is not
considered a public water system if it
does not regularly serve an average of at
least twenty-five individuals daily at
least 60 days out of the year. The ADWR
applies to aircraft (regardless of
ownership) that fly routes between two
or more locations within the U.S., while
the aircraft is within U.S. jurisdiction.
For instance, an aircraft flying an
international route that serves only one
U.S. location would not generally be
considered a PWS. Another example is
an aircraft that is used solely for
military purposes, is not conveying
passengers in interstate commerce, and
meets all of the other exclusion criteria
under SDWA section 1411; in this case,
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the aircraft would also be excluded from
regulation under the NPDWRs and the
ADWR.
An estimated 63 air carriers and 7,327
aircraft water systems are regulated by
this rule.
D. Regulatory and Enforcement History
SDWA, including the amendments of
1986 and 1996, requires EPA to
promulgate NPDWRs to prevent tap
water contamination that may adversely
affect human health. As previously
noted, aircraft are subject to certain
NPDWRs specific to TNCWS. 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). Since then, EPA has
determined that a new rule, the ADWR,
specifically adapted to aircraft water
systems would provide a clearer and
more implementable regulatory
framework for aircraft water systems.
EPA suspended WSG 29 in 2003 and is
no longer approving operation and
maintenance programs in lieu of
monitoring.
As discussed in the preamble to the
proposed rule (73 FR 19323, April 9,
2008), 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 under 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 water systems. In the
interim, EPA placed 45 air carriers
under Administrative Orders on
Consent (AOCs) that will remain in
effect until 24 months following
publication of the final rule.
The ADWR adapts to aircraft water
systems the applicable requirements
from the Total Coliform Rule (TCR), the
suite of surface water treatment
regulations, and the Public Notification
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
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Maximum Contaminant Level (MCL) for
total coliforms and requires testing of
total coliform-positive cultures for the
presence of fecal coliforms or E. coli.
Fecal coliforms or E. coli indicate more
immediate health risks from sewage or
fecal contamination and are used as an
indicator 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 five years for systems that collect
fewer than five total coliform samples
per month (those serving 4,100 people
or fewer). A TNCWS using surface water
serving less than 1,000 individuals daily
would typically be required to take one
total coliform sample per month for
routine sampling requirements.
Under 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.
In addition to the EPA requirements,
air carriers have many different ongoing programs and practices for
assessing and correcting deficiencies
and risks associated with the drinking
water supply and related safety,
security, and sanitation issues. For
example, such programs and practices
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
requirements of aircraft sanitation
systems including potable (finished)
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water, sewage, and galleys. These
programs may contribute valuable
information related to the condition of
the aircraft water system and water
quality. Throughout the rule’s
development, EPA has worked closely
with FDA and FAA to ensure that the
ADWR is integrated with these
programs to avoid unnecessary
duplication.
III. Final Rule Development
A. Stakeholder Involvement
As discussed in the proposed ADWR,
EPA announced in 2004 that it had
initiated a rulemaking process to
develop regulations for aircraft water
systems. (73 FR 19324, April 9, 2008).
The Agency committed to working
collaboratively with other Federal
agencies (e.g., FDA and FAA) 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 final ADWR.
EPA 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.
This pre-proposal input greatly assisted
EPA in the rule’s development.
EPA proposed the ADWR on April 9,
2008 (73 FR 19320), and requested
public comment. The 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. EPA received
comments on the proposal and has
made revisions to this final rule that
increases regulatory flexibility and
adaptability to the airline industry’s
operations, while ensuring public health
protection. Section IV of this notice
describes how EPA incorporated public
comments into revisions to the final
rule. A Response to Comments
Document is available in the docket for
today’s action.
B. Aircraft Drinking Water Quality
1. Data Collection Efforts
To better understand aircraft drinking
water quality, EPA analyzed sampling
results submitted by air carriers under
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Administrative Orders on Consent
(AOCs) from 2005–2008. As detailed in
the proposed ADWR, EPA also drew
upon the results of the following three
studies: (1) A 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
(73 FR 19324).
The AOCs established interim aircraft
water testing and disinfection protocols.
As part of the AOCs’ requirements, air
carriers were required to submit two
documents for EPA approval, which 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. As reflected in Table
III–1, air carriers followed slightly
different monitoring and disinfection
protocols based on their fleet size.
TABLE III–1—MONITORING AND DISINFECTION PROTOCOLS AS REQUIRED UNDER THE AOCS
Air carriers
with greater
than 20
aircraft
MONITORING: 1
For each sample event, collect at least one sample from a galley and one from a lavatory for total coliform and disinfectant residual (total residual chlorine) .................................................................................
Sample 25% of fleet quarterly ..........................................................................................................................
Sample all fleet quarterly ..................................................................................................................................
DISINFECTING AND FLUSHING: 2
Disinfect and flush each aircraft’s water system no less than quarterly .........................................................
Disinfect and flush watering points (e.g., water trucks, carts, cabinets, hoses) no less than monthly ...........
Air carriers
with less than
or equal to 20
aircraft
✓
✓
........................
✓
........................
✓
✓
✓
✓
✓
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 had a pre-AOCs 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.
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2. Microbiological Occurrence for the
Estimated Baseline
As of December 31, 2008, EPA has
processed drinking water sampling data
from 25 of the 45 air carriers under the
AOCs. From these 25 air carriers, EPA
processed a total of 20,156 total coliform
samples (13,872 routine and 6,284
repeat) and 17,267 chlorine residual
samples. These 25 air carriers represent
78 percent of the total estimated AOCs’
fleet size (5,558 aircraft) and 79 percent
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of the total expected annual number of
routine samples. However, data for air
carriers with an EPA-approved QAPP
and CRMP are only available from 2 air
carriers in 2005, 5 air carriers in 2006,
8 air carriers in 2007, and 12 air carriers
in 2008.
The following data summaries are
from air carriers with an EPA-approved
QAPP and CRMP. As noted above, not
all 25 air carriers provided data
collected under an EPA-approved QAPP
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and CRMP for all four years. Therefore,
insufficient data are currently available
to support statistical evaluation of the
data sets. However, the data were used
to provide an observational indication
of trends. It should be noted that total
coliform repeat samples by nature have
a higher probability of being positive
since repeat samples are taken after a
routine sample is total coliformpositive. Consequently, the occurrence
baseline for total coliform and E. coli/
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fecal coliform occurrence was based on
routine samples only. Table III–2
presents data for routine total coliform
samples collected under EPA-approved
QAPPs and CRMPs.
Of the total 20,156 total coliform
samples received, 93 percent or 18,724
samples (12,794 routine and 5,930
repeat samples) were from air carriers
with an EPA-approved QAPP and
CRMP. Of the 12,794 routine samples,
3.6 percent (463 samples) were positive
for total coliform and 3.9 percent (18
samples (0.8 percent, or 47 of 5,695
galley samples), the galley samples had
a higher E. coli/fecal coliform
occurrence of 12.8 percent (6 of 47 total
coliform-positive samples), compared to
2.9 percent (12 of 413 total coliformpositive samples) in the lavatories. More
details on the routine coliform data set
by calendar quarter and by sample
collection location on the aircraft are
presented in the following table (Table
III–2).
samples) of the total coliform-positive
samples were E. coli/fecal coliformpositive. Of the 463 total coliformpositive routine samples, 413 were
collected in the lavatory, 47 were
collected in the galley, and one was a
composite sample of galley and lavatory
sources; the location of the remaining
two positive results are unknown.
Although the lavatory samples had a
higher total coliform-positive
occurrence rate (5.9 percent, or 413 of
7,027 lavatory samples) than the galley
TABLE III–2—AOCS OCCURRENCE BASELINE DATA—ROUTINE TOTAL COLIFORM SAMPLES OF AIR CARRIERS WITH EPAAPPROVED QAPPS AND CRMPS (YEARS 2005–2008)
Percent TC+
Of the TC+
samples,
percent EC+
or FC+
Total # of TC+
samples
Total # of TC+
samples that
are EC+ or
FC+
Total # of TC
samples
Total Coliform Data by Calendar Quarter
Calendar
Calendar
Calendar
Calendar
Qtr
Qtr
Qtr
Qtr
1
2
3
4
.....................................................................
.....................................................................
.....................................................................
.....................................................................
3.2
3.5
4.1
4.1
4.0
3.5
0.0
8.1
100
198
79
86
4
7
0
7
3,145
5,641
1,930
2,078
Total ..............................................................................
3.6
3.9
463
18
12,794
Total Coliform Data by Sample Location
Galley ...................................................................................
Lavatory ...............................................................................
Composite* ...........................................................................
Unknown Sample Site .........................................................
0.8
5.9
14.3
3.1
12.8
2.9
0
0
47
413
1
2
6
12
0
0
5,695
7,027
7
65
Total ..............................................................................
3.6
3.9
463
18
12,794
* Composite sample of Galley and Lavatory sources.
Note: ‘‘TC+’’ means total coliform-positive; ‘‘EC+ or FC+’’ means E. coli-positive or fecal coliform-positive.
Note: For air carriers with EPA-Approved QAPPs and CRMPs (Years 2005–2008), out of a total number of 12,794 routine samples, a total of
18 samples (0.14%) were EC+ or FC+.
3. Residual Chlorine Estimated Baseline
Table III–3 presents data for
disinfectant residual samples collected
under EPA-approved QAPPs and
CRMPs during routine and repeat total
coliform sampling events. Of the 18,724
routine and repeat total coliform sample
events reported, 16,109 disinfectant
residual sample results were also
reported. Results were reported as either
‘‘detect’’ with the residual value
recorded, or ‘‘non-detect.’’ Disinfectant
residual data were not provided for
2,615 coliform sample events.
samples) of the composite samples were
non-detects. A sample location was not
identified for 13 samples with a
detectable residual. While not
statistically significant, the occurrence
of non-detectable disinfectant residuals
appeared to increase in months with
warmer weather. Quarter 3 (i.e., July to
September) had the highest percentage
of samples with a non-detectable
disinfectant residual (30.2%), although
as shown in Table III–2, Quarter 3
routine total coliform sample results
showed no appreciable increase in the
percentage of coliform-positive samples.
Disinfectant residual data are presented
for the total of routine and repeat
sample collection events because repeat
samples have no higher or lower
probability of having a detectable
residual than routine samples.
For air carriers with approved QAPPs
and CRMPs, approximately 18.2 percent
(2,927 samples) of the 16,109
disinfectant residual results processed
from 2005 to 2008 had a non-detectable
disinfectant residual. Non-detectable
levels were similar in galleys (17.3
percent) and lavatories (18.9 percent),
while 22.4 percent (73 out of 326
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TABLE III–3—AOCS OCCURRENCE BASELINE DATA—DISINFECTANT RESIDUAL ROUTINE AND REPEAT SAMPLES OF AIR
CARRIERS WITH EPA-APPROVED QAPPS AND CRMPS (YEARS 2005–2008)
Percent
disinfectant
residual
non-detect
Total # of
disinfectant
residual
non-detect
Total # of
disinfectant
residual
detect
Total # of
disinfectant
residual
samples
Disinfectant Residual Data by Calendar Quarter
Unknown Calendar Qtr ....................................................................................
Calendar Qtr 1 .................................................................................................
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53595
TABLE III–3—AOCS OCCURRENCE BASELINE DATA—DISINFECTANT RESIDUAL ROUTINE AND REPEAT SAMPLES OF AIR
CARRIERS WITH EPA-APPROVED QAPPS AND CRMPS (YEARS 2005–2008)—Continued
Percent
disinfectant
residual
non-detect
Total # of
disinfectant
residual
non-detect
Total # of
disinfectant
residual
detect
Total # of
disinfectant
residual
samples
Calendar Qtr 2 .................................................................................................
Calendar Qtr 3 .................................................................................................
Calendar Qtr 4 .................................................................................................
9.3
30.2
21.6
632
813
618
6,128
1,879
2,242
6,760
2,692
2,860
Total ..........................................................................................................
18.2
2,927
13,182
16,109
Disinfectant Residual Data by Sample Location
Galley ...............................................................................................................
Lavatory ...........................................................................................................
Composite * ......................................................................................................
Unknown Sample Site .....................................................................................
17.3
18.9
22.4
0.0
1,336
1,518
73
0
6,386
6,530
253
13
7,722
8,048
326
13
Total ..........................................................................................................
18.2
2,927
13,182
16,109
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* Composite sample of Galley and Lavatory sources
It appears that a non-detectable
disinfectant residual is not associated
with an increase in total coliformpositive samples. Of the 801 total
routine and repeat samples that were
total coliform-positive, 24 did not
include any data on a disinfectant
residual. Of the remaining 777 total
coliform-positive routine and repeat
samples, 584 samples (75 percent) had
a detectable disinfectant residual and
193 samples (25 percent) did not have
a detectable disinfectant residual.
Twenty-one (3.6 percent) of the 584
total coliform-positive routine and
repeat samples with a detectable
residual (the lowest measuring 0.05 mg/
L) also tested positive for E. coli/fecal
coliforms. Only one (0.5 percent) of the
193 total coliform-positive samples did
not have a detectable residual and tested
positive for E. coli/fecal coliforms.
Seventy-three samples had nondetectable disinfectant residual and
were reported to have carbon filters
installed on the water lines to the
sample tap; two of those samples were
total coliform-positive. For comparison,
364 samples with detectable
disinfectant residual were reported to
use carbon filters; three of those samples
were total coliform-positive. Aside from
charcoal/carbon, and particle removal
filters in some galleys and lavatories,
the majority of aircraft do not provide
additional treatment for boarded water.
For more details on aircraft drinking
water sample results under the AOCs,
see Chapter 3 and Appendix B of the
Economic and Supporting Analyses for
the Final ADWR.
IV. Elements of the Final Aircraft
Drinking Water Rule
The following sections describe the
elements of the final rule as developed
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by EPA. EPA specifically designed the
rule to allow air carriers to be consistent
with the manufacturer recommendations for disinfecting and flushing
aircraft water systems, instead of
prescribing the frequency, chemical
type and concentration to be used. By
allowing air carriers to be consistent
with the manufacturer
recommendations for disinfection and
flushing, the rule requirements will
automatically evolve with technological
improvements in aircraft water tank
lining and piping materials, and as new
more effective disinfectants are
developed.
EPA requested comment on all
aspects of the rule in its proposal of
April 9, 2008 (73 FR 19320); however,
EPA did not request and did 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 the proposed
rule. In addition to rule requirements,
EPA identified specific requests for
comment on subject matters pertaining
to the proposed rule. The public
comment period for the April 9, 2008,
proposed ADWR closed on July 8, 2008.
The following sections of this preamble
explain the final rule and present, when
applicable, a summary of the major
public comments received. In addition,
EPA has responded to all of the public
comments in its Response to Comment
document, which can be found in the
docket for this rule (see ADDRESSES of
this notice to obtain information on
accessing the docket).
A. Definitions (§ 141.801)
All definitions included in the
proposed rule (73 FR 19343), remain the
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same in today’s final rule except for the
definitions for Aircraft Water System
Operations and Maintenance Plan and
Watering Point.
In the proposed rule, the definition
for Aircraft Water System Operations
and Maintenance Plan reads, ‘‘Aircraft
Water System Operations and
Maintenance Plan means the schedules
and procedures for operating,
monitoring, and maintaining an aircraft
water system that is included in an
aircraft operations and maintenance
program approved or accepted by the
Federal Aviation Administration
(FAA).’’ Since the publication of the
proposed rule, the Agency has learned
that FAA does not ‘‘approve’’ the air
carrier operations and maintenance
programs, and that describing these
programs as ‘‘FAA-accepted’’ programs
is more accurate. Thus, in the final rule,
EPA removes the word ‘‘approved’’ from
the definition.
In the proposed rule, the definition
for Watering Point reads, ‘‘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.’’ However, the Agency
received comments concerning selection
of watering points in § 141.804. The
commenters (details under Section IV. F
of this notice) believed that EPA
intended to alter Food and Drug
Administration (FDA) regulations
applicable to watering points. EPA did
not intend to alter these regulations, and
clarifies in today’s final rule that it is
the Agency’s intent to keep the rule
consistent with existing FDA
regulations. Thus, the Agency is
revising the definition for Watering
Point to read, ‘‘Watering Point means
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B. Sampling Requirements (§§ 141.802
and 141.803)
This section begins with a summary
of the major sampling requirements of
the final ADWR, then addresses public
comments received on the proposed
ADWR related to changes EPA has made
to the final rule requirements. Finally,
EPA provides responses to the ‘‘Request
for Comment’’ issues posed in the
proposal designed to aid the Agency in
developing requirements under the final
ADWR.
In keeping with the TCR, today’s rule
reiterates that 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
is not required. In addition, this final
rule specifies that only analytical
methodologies approved by EPA are to
be used for sample analysis. For routine
total coliform monitoring, each aircraft
water system water sample must be 100
mL. For most systems, one sample must
be collected from a lavatory and one
sample from a galley. Each sample must
be analyzed for total coliforms. If total
coliforms are detected, the sample must
further be analyzed for E. coli. Under
this rule, E. coli is the indicator that
fecal contamination may have occurred.
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 to be analyzed
for total coliforms. If an aircraft water
system has a removable/portable tank,
that is drained at least every day of
passenger service and there is one tap
on the aircraft, the air carrier may
collect one 100 mL sample from the
available tap (i.e., galley or lavatory).
extends the compliance date for
development of the coliform sampling
plan to 18 months after publication of
the final rule.
Under the proposed and final rules,
an air carrier must develop a coliform
sampling plan for each aircraft water
system it owns and operates. The
coliform sampling plan must be
included in the Aircraft Water System
Operations and Maintenance Plan
required in § 141.804. The air carrier
need not develop a separate coliform
sampling plan for each aircraft, but the
air carrier must ensure that each aircraft
it owns and operates is covered by a
plan. For example, if the air carrier
operates several of the same type of
aircraft water system with the same
coliform sampling frequency,
procedures, sampling tap locations, etc.,
the air carrier may choose to develop
one coliform sampling plan that applies
to all aircraft of this type in the air
carrier’s fleet.
While most of the sampling plan
requirements are the same in the
proposed and final rules, the Agency
received comments that the proposed
rule was unclear as to whether and how
air carriers could amend their
operations and maintenance plans or
their coliform sampling plans. EPA
agrees that the final rule should more
clearly state the requirements for
making changes to these plans. Thus, in
the final rule, EPA addresses this
concern by clarifying that any
subsequent changes to the coliform
sampling plan must also be included in
the Aircraft Water System Operations
and Maintenance Plan. Changes to the
coliform sampling plan could include
changes to any of the requirements
listed in this section, including changes
to the frequency of routine coliform
sample collection. In addition, both the
reporting requirements and the
requirements for the operations and
maintenance plan have been revised to
respond to these comments.
1. Coliform Sampling Plan (§ 141.802)
EPA proposed to allow six months for
air carriers to develop a coliform
sampling plan for each aircraft
following publication of the rule.
However, the Agency received several
comments requesting that the
compliance date be extended in order to
allow more time for air carriers to
restructure maintenance programs
between the AOCs and the final rule.
The comments and the Agency’s
response are explained in more detail in
section IV. L of this notice. EPA agrees
that more time may be needed for air
carriers to develop a coliform sampling
plan. Therefore, today’s final rule
2. Coliform Sampling Requirements
(§ 141.803)
In the proposed rule, all air carriers
would be required to collect the same
volume and number of samples
regardless of aircraft size:
• For routine samples—collect two
100 mL samples: one from a lavatory
and one from a galley. If only one tap
is available—collect two ‘‘separate’’ 100
mL samples.
• For repeat samples—collect four
100 mL samples: one from the positive
tap, one other lavatory, one other galley,
and one other tap. If less than four taps
are available—collect four 100 mL
samples from the available taps.
sroberts on DSKD5P82C1PROD with RULES
the water supply, methods, and
facilities used for delivery of finished
water to the aircraft. These facilities
may include water trucks, carts,
cabinets and hoses.’’
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In the proposed rule, routine
sampling frequencies were based on the
routine disinfection and flushing
frequency as detailed in the following
table (Table IV–1):
TABLE IV–1—PROPOSED RULE REQUIREMENTS FOR ROUTINE DISINFECTION AND FLUSHING AND SAMPLING
Disinfection & flushing
frequency per aircraft
PWS
Coliform sampling frequency per aircraft
PWS
Once per Quarter (4
times per year).
Once to 3 times per
year.
Less than once per
year.
Annually.
Quarterly.
Monthly.
If not specified by the manufacturer, disinfection and flushing must be no less frequent
than once per quarter.
Public comments on the proposed
rule raised several concerns related to
(1) the lavatory as a sampling location
site, and (2) the routine frequencies for
disinfection and flushing, and coliform
monitoring. EPA received several public
comments regarding the elimination of
lavatory samples. Several commenters
stated that lavatory sampling should be
eliminated because it is not
representative of the water actually
consumed for drinking purposes on
aircraft and, requiring the sampling of
lavatories mischaracterizes risks unless
(1) there are no other sampling locations
available on the aircraft; and/or (2) the
airline takes affirmative steps to offer
water in the lavatories for drinking
purposes, such as providing drinking
cups. EPA disagrees with these
comments. In today’s rule, air carriers
must collect a total coliform sample
from one galley and one lavatory, when
available. Collection of samples from
the lavatory is necessary since this
water may be used for human
consumption (e.g., brushing teeth, hand
washing). Additionally, lavatory
samples are as representative of the
aircraft drinking water quality as galley
samples when proper collection
techniques/procedures are used to
minimize the frequency of positive
results due to surface contamination or
improper collection procedures. EPA
plans to discuss these issues further in
its separate ADWR technical guidance.
EPA received the following two major
comments regarding routine
disinfection and flushing, and coliform
monitoring frequencies: (1) Reduce the
sample collection for small volume
aircraft water systems (e.g., regional jets
with 5-gallon removable tanks), and (2)
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extend the minimum disinfection
intervals to accommodate for less
frequent disinfection based on sampling
results.
With respect to sampling number and
volume, commenters expressed concern
that the proposed ADWR was unduly
complicated (e.g., number of total
coliform samples collected was too
much) for small tanks (e.g., regional jets
with 5 gallons) that are removable/
portable and are drained daily; and that
the rule does not account for varying
sizes of aircraft. EPA agrees with the
comments regarding aircraft with small
drinking water tanks and today’s rule
incorporates the following changes:
• For aircraft water systems that have
a removable/portable drinking water
tank that is drained every day of
passenger service, and the aircraft has
only one tap, air carriers may collect
one 100 mL routine sample from the
available tap; and
• Collect three 100 mL repeat samples
when performing the corrective action
upon the receipt of a total coliformpositive sample. This reduction in
repeat samples also applies to all tank
types.
EPA believes these reductions are
appropriate because the complexity of
aircraft water systems with removable/
portable tanks and one tap on the
aircraft is low (e.g., few feet of tubing/
pipes; few potential points for cross
contamination); and the reductions
maintain consistency with the
recommendations of the Federal
Advisory Committee—The Total
Coliform Rule/Distribution System
Advisory Committee (TCRDSAC)—to
reduce sampling volume and frequency
for small non-community stationary
systems (see docket for the TCRDSAC
Agreement in Principle, signed
September 18, 2008). EPA also believes
that the economic and logistical burden
53597
on air carriers, particularly small
regional jets, will be minimized by
taking fewer samples.
Public comment on the proposed
ADWR disinfection and flushing, and
monitoring frequencies centered around
two main issues: (1) Extend the
minimum disinfection intervals to
accommodate an approach that focuses
on risk and allows for less frequent
disinfection based on sampling results,
and (2) set ‘‘reasonable minimum’’
disinfection timelines consistent with
the AOCs of some major air carriers to
align a semi-annual disinfection
schedule with an annual sampling
schedule, thereby reducing the
‘‘significant’’ economic cost to
restructure in-place disinfection
programs. EPA agrees that some changes
are warranted and today’s rule includes
revised requirements to the routine
frequencies as presented in Table IV–2:
TABLE IV–2—FINAL RULE REQUIREMENTS FOR ROUTINE DISINFECTION AND FLUSHING AND ROUTINE SAMPLING
FREQUENCIES
Minimum routine disinfection & flushing
per aircraft
Minimum frequency of routine samples
per aircraft
At least 4 times per year = At least once within every three-month period (quarterly).
At least 3 times per year = At least once within every four-month period.
At least 2 times per year = At least once within every six-month period
(semi-annually).
At least 1 time per year or less = At least once within every twelvemonth period (annually) or less.
At least 1 time per year = At least once within every twelve-month period (annually).
At least 2 times per year = At least once within every six-month period
(semi-annually).
At least 4 times per year = At least once within every three-month period (quarterly).
At least 12 times per year = At least once every month (monthly).
sroberts on DSKD5P82C1PROD with RULES
If not specified by the manufacturer, select any frequency that is no less stringent than these four disinfection and flushing frequencies which
meet the aircraft’s unique operational needs.
EPA considers disinfection and
flushing to be a more protective and
pro-active public health measure than
monitoring. Therefore, EPA re-aligned
the disinfection and flushing and
monitoring frequencies in order to
emphasize the importance of
disinfection and flushing in comparison
to monitoring. As a result, those air
carriers that conduct more frequent
disinfection and flushing do not have to
monitor as frequently. Today’s final rule
requires an air carrier that conducts
disinfection and flushing three times
per year to perform sampling twice a
year instead of four times per year. And
an air carrier that conducts disinfection
and flushing once per year or less must
sample monthly. With respect to the
commenter’s concern about
accommodating a semi-annual
disinfection and flushing frequency
with annual sampling (as allowed under
some AOCs), the ADWR continues to
accommodate the semi-annual
disinfection and flushing schedule.
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However, EPA believes that linking this
with annual sampling would be
inconsistent with the importance of
disinfection and flushing as the
preferred, pro-active measure. As
reflected in Table IV–2, today’s rule
continues to require air carriers that
conduct disinfection and flushing semiannually to conduct monitoring four
times per year.
While the frequencies in Table IV–2
provide air carriers with enough
flexibility to schedule both routine
disinfection and flushing and routine
monitoring in a way that avoids
disruption to passenger service, EPA
intends for air carriers to schedule
routine disinfection and flushing and
routine monitoring at regular intervals
throughout the calendar year. Routine
disinfection and flushing should be
scheduled so that the amount of time
between each disinfection and flushing
event is approximately equal. EPA
believes that this will maximize the
effectiveness of the disinfection and
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flushing event. Similarly, routine
monitoring should be scheduled so that
the amount of time between each
monitoring event is approximately
equal. EPA does not intend for routine
disinfection and flushing events to take
place back-to-back such that
disinfection and flushing occurs at the
end of one disinfection and flushing
period and again at the beginning of the
following period. Nor should air carriers
schedule routine monitoring events to
take place back-to-back such that
samples are taken at the end of one
monitoring period and again at the
beginning of the following period.
In addition, the Agency received
comment that the requirement to
disinfect and flush quarterly, when no
manufacturer recommendations were
available, did not provide flexibility. In
today’s rule, EPA removed this
requirement (as reflected in Table IV–2)
so that when there is no manufacturer
recommendation, air carriers can select
any of the routine frequencies that best
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sroberts on DSKD5P82C1PROD with RULES
meet their unique operations and
maintenance needs.
EPA was unable to make a
determination on a risk-based approach
that supports a reduced frequency for
disinfection and flushing based on
sampling results, because no new data
were provided beyond the AOCs’ data.
The AOCs’ data protocols were not
designed to establish risk-based
frequencies. AOCs are interim measures
used to aid air carriers to meet
compliance with SDWA and provide an
understanding of aircraft drinking water
quality. At this time, EPA believes the
final rule frequencies provide the
minimum requirements necessary for
public health protection, while also
providing adequate flexibility to meet
the evolving needs of the industry, such
as transitioning from the AOCs’
requirements to the ADWR.
3. Analytical Methods (§ 141.803(a))
In the proposed rule, EPA stated that
air carriers must use EPA-approved
analytical methodologies for the
analysis of coliform bacteria. Public
comment was received regarding the
specific use of concurrent analytical
methods that test for total coliforms and
E. coli simultaneously. The commenter
named several concurrent methods that
they felt provide ‘‘great benefit’’ to the
industry, because the methods are
timely and accurate. Although some of
these noted methods are EPA-approved,
the final rule reiterates and clarifies that
air carriers must use only the EPAapproved analytical methods for
analyzing total coliforms and/or E. coli
in drinking water samples as specified
in § 141.21(f)(3) and § 141.21(f)(6) of the
Code of Federal Regulations, or their
equivalent as approved by EPA to
demonstrate compliance with the
ADWR sampling requirements. EPA has
approved several methods for use that
allow the simultaneous detection of
both total coliforms and E. coli. These
methods are also approved for use
under this rule.
In the proposed rule, EPA required air
carriers to use a State- or EPA-certified
laboratory for analysis of drinking water
samples. For compliance with the
ADWR, one commenter encouraged EPA
to allow the use of foreign laboratories
to conduct analysis on drinking water
samples as permitted under the
Administrative Orders on Consent
(AOCs). In addition, the commenter
noted that air carriers should be allowed
to conduct disinfection of their aircraft
water systems ‘‘at locations outside the
U.S.’’ The final rule clarifies and
reiterates that drinking water
microbiological samples submitted for
compliance with the ADWR must be
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analyzed by a certified laboratory to
ensure the use of approved analytical
methods and approved quality control
procedures for checking analytical data
for completeness and correctness. A
certified laboratory is a laboratory that
is certified by EPA or a State. ‘‘State’’
refers to a U.S. State or Tribe that has
received primacy for public water
systems (other than aircraft water
systems) under section 1413 of the
SDWA. By allowing the use of any
laboratory that is certified by a State or
EPA for analysis of drinking water
samples, the ADWR provides air carriers
with greater flexibility in designing their
sampling programs while maintaining
protection of public health.
In one AOC, for a specific set of the
fleet (i.e., 47 aircraft) an air carrier was
permitted to use a foreign laboratory,
which was neither EPA- nor Statecertified, to perform analysis of drinking
water samples provided that the
samples were analyzed using EPAapproved analytical methods. The
commenter incorrectly assumed that
this allowance would fulfill SDWA
compliance. In today’s notice, the
Agency makes clear that this allowance
was not intended for compliance
purposes under the SDWA. The ADWR
does not prevent collection of samples
outside the U.S. However, foreign
laboratories must be an EPA- or a Statecertified laboratory in order to analyze
the drinking water samples for
compliance with the ADWR. EPA plans
on addressing these issues in more
detail in its ADWR technical guidance.
EPA notes that the ADWR requirements
do not prevent air carriers from
performing disinfection and flushing
outside the U.S. for compliance with the
ADWR.
C. Responses to Sampling Results
(§ 141.803)
As specified in the proposed rule, air
carriers would 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.
Under the proposal, upon receipt of a
total coliform-positive result, air carriers
would be required to further analyze the
positive sample for the presence of fecal
coliforms, except that the system could
test for E. coli in lieu of fecal coliforms.
EPA received public comment
requesting the removal of fecal
coliforms as indicators. EPA agrees with
this comment and today’s rule
eliminates the use of fecal coliforms as
indicators of potential fecal
contamination. As a consequence, the
final rule specifies that upon receipt of
a total coliform-positive result, air
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carriers must further analyze that
sample for E. coli only. The fecal
coliform group (also referred to as
thermotolerant coliforms) has been
found to sometimes contain
environmental bacteria that are not of
fecal origin. Thus, the presence of fecal
coliform bacteria in a water sample is
not necessarily indicative of the
potential for fecal contaminants being
present. Thus, analyzing for E. coli
provides more meaningful data to
protect public health. This change is
consistent with the recommendations of
the Federal Advisory Committee—
TCRDSAC.
In the proposed rule, air carriers
would be required to perform the
following corrective actions based on a
positive coliform result:
(1) If one routine sample was total
coliform-positive and E. coli/fecal
coliform-negative then the air carrier
would be required to:
• Within 72 hours of receipt of the
positive result from the laboratory,
disinfect and flush the water system,
and collect follow-up samples; or
• Within 24 hours of receipt of the
positive result from the laboratory,
collect four repeat samples.
(2) If two or more routine samples or
any repeat samples were total coliformpositive and E. coli/fecal coliformnegative, or if any sample was E. coli/
fecal coliform-positive then the air
carrier was required to:
• Within 24 hours of receipt of the
positive result from the laboratory,
restrict public access. Restrict public
access included the following activities
for the aircraft in question: Physically
disconnect or shut-off the water system
where feasible; provide public
notification to passengers and crew if
the water system could not be shut-off,
but if the system could be shut-off, then
provide public notice to the crew only;
and provide alternatives to the use of
the water system such as antiseptic
alcohol-based hand gels or wipes and
bottled water (that reduce or eliminate
the need to use the water system during
the limited period before access is
restored); and
• Within 72 hours of receipt of the
positive result from the laboratory,
disinfect and flush the water system and
collect follow-up samples if the system
could not be physically disconnected or
shut-off. If the water system could be
shut-off to prevent access to passenger
and crew, disinfect and flush when able.
Public comment on the proposed
ADWR noted several concerns related to
the corrective actions upon receipt of a
positive coliform result. Commenters
stated that the proposed ADWR lacked
flexibility to avoid passenger and
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airspace disruptions that may occur
when an aircraft cannot be pulled outof-service to disinfect and flush in 72
hours (e.g., if results are received during
an international flight). Commenters
recommended EPA increase the
timeframe from 72 hours to 96 or 120
hours to avoid inconveniencing
travelers (due to delays, cost, or loss of
service). Additionally, commenters
stated that an aircraft should not be
grounded ‘‘solely’’ for a problem
associated with the aircraft water
system. EPA agrees that some flexibility
is warranted to avoid unnecessarily
grounding the aircraft, and for the final
rule, better aligned the corrective
actions so that non-fecal microbiological
occurrences have the same corrective
actions regardless of the number of
samples that test total coliform-positive
and E. coli-negative.
Generally, most members of the total
coliform bacterial group do not pose a
risk to human health. The presence of
total coliforms only (i.e., no E. coli are
detected) presents a non-fecal potential
health risk and is an indication of poor
water quality that could be caused by
stagnant water, a failure of treatment
equipment intended to improve the
aesthetic quality of the water (such as
carbon filters) or inadequate routine
maintenance of the water system, among
others. However, EPA considers that an
E. coli-positive result is an acute
potential fecal health risk, and it is a
necessary public health measure to
ground the plane in 72 hours when the
water system cannot be physically
disconnected or the flow of water
prevented through the taps. Therefore,
no changes were made to the corrective
actions for E. coli-positive results.
The final rule reflects corrective
action changes to non-fecal coliform
occurrence when an air carrier receives
a total coliform-positive result that is
also E. coli-negative. These changes are
also consistent with recommendations
of the Federal Advisory Committee—
TCRDSAC for stationary systems under
the Total Coliform Rule, whereby the
occurrence of routine total coliformpositive results that are E. coli-negative
should not be considered a maximum
contaminant level (MCL) violation.
Therefore, in a set of routine samples, if
one or more are total coliform-positive
and E. coli-negative, the air carrier can
select any of the following corrective
actions and follow through with that
action until a set of total coliform
samples is total coliform-negative:
(1) Within 72 hours of receipt of the
routine positive result from the
laboratory, the air carrier must disinfect
and flush, and collect follow-up
samples prior to providing water for
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human consumption from the aircraft
water system. From the time follow-up
samples are taken and submitted for
analysis to the time of receiving the
results, air carriers may provide water
for human consumption from the
aircraft water system to passengers and
crew. If any follow-up sample is total
coliform-positive and E. coli-negative,
the air carrier must perform all of the
following:
a. Conduct the Restrict Public Access
requirements within 72 hours, and;
b. Conduct a second disinfection and
flushing, and;
c. Collect follow-up samples prior to
providing water for human
consumption from the aircraft water
system. From the time follow-up
samples are taken, as a result of the
second disinfection and flushing, to the
time of receiving the results, air carriers
must continue all Restrict Public Access
provisions. If the second set of followup results are total coliform-positive
and E. coli-negative, then the air carrier
must continue to disinfect and flush the
aircraft water system until a set of total
coliform samples is total coliformnegative; or
(2) Within 24 hours of receipt of the
routine positive result from the
laboratory, the air carrier must collect
three repeat samples. From the time
repeat samples are taken and submitted
for analysis to the time of receiving the
results, air carriers may provide water
for human consumption from the
aircraft water system to passengers and
crew. If any repeat sample is total
coliform-positive and E. coli-negative,
the air carrier must perform one of the
following:
a. Conduct disinfection and flushing
within 72 hours, and collect follow-up
samples prior to providing water for
human consumption from the aircraft
water system. From the time follow-up
samples are taken and submitted for
analysis to the time of receiving the
results, air carriers may provide water
for human consumption from the
aircraft water system to passengers and
crew. If any follow-up sample is total
coliform-positive and E. coli-negative,
the air carrier must conduct the Restrict
Public Access requirements within 72
hours, and perform a second
disinfection and flushing and collect
follow-up samples. From the time
follow-up samples are taken, as a result
of the second disinfection and flushing,
to the time of receiving the results, air
carriers must continue all restrict public
access provisions. If the second set of
follow-up results are total coliformpositive and E. coli-negative, then the
air carrier must continue to disinfect
and flush the aircraft water system until
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53599
a set of total coliform samples is total
coliform-negative. Or,
b. Conduct the Restrict Public Access
requirements within 72 hours, and
perform disinfection and flushing and
collect follow-up samples prior to
providing water for human
consumption from the aircraft water
system. From the time follow-up
samples are taken and submitted for
analysis to the time of receiving the
results, air carriers may provide water
for human consumption from the
aircraft water system to passengers and
crew. If any follow-up sample is total
coliform-positive and E. coli-negative,
the air carrier must conduct the Restrict
Public Access requirements within 72
hours, and perform a second
disinfection and flushing and collect
follow-up samples. From the time
follow-up samples are taken, as a result
of the second disinfection and flushing,
to the time of receiving the results, air
carriers must continue all Restrict
Public Access provisions. If the second
set of follow-up results are total
coliform-positive and E. coli-negative,
then the air carrier must continue to
disinfect and flush the aircraft water
system until a set of total coliform
samples is total coliform-negative. Or,
(3) Within 72 hours of receipt of the
routine positive result from the
laboratory, the air carrier must perform
the Restrict Public Access requirements
until operationally feasible to disinfect
and flush, and collect follow-up
samples. Once disinfection and flushing
is performed, and a set of follow-up
samples are taken and submitted for
analysis, then the air carrier may cease
the Restrict Public Access provisions
and provide water for human
consumption from the aircraft water
system to passengers and crew. If the
follow-up sample result from this first
disinfection and flushing is total
coliform-positive and E. coli-negative,
the air carrier must perform all of the
following:
a. Conduct the Restrict Public Access
requirements within 72 hours, and
b. Conduct a second disinfection and
flushing and collect follow-up samples.
From the time follow-up samples are
taken, as a result of the second
disinfection and flushing, to the time of
receiving the results, air carriers must
continue all Restrict Public Access
provisions. If the second set of followup results are total coliform-positive
and E. coli-negative, then the air carrier
must continue to disinfect and flush the
aircraft water system until a set of total
coliform samples is total coliformnegative.
As compared to the proposed ADWR,
the changes made to the aforementioned
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corrective actions for routine total
coliform-positive samples that are E.
coli-negative, include a third action to
restrict public access, and the timeframe
for the initial response has been
changed from 24 hours to 72 hours to
better align with the other two options
for non-fecal routine occurrences. In
addition, under any of the three
corrective action options for non-fecal
occurrences, upon completion of the
first disinfection and flushing event,
and follow-up samples are taken and
submitted for analysis, the air carrier
may provide water for human
consumption to passengers and crew
from the aircraft water system until
laboratory results are received. Water is
permitted to be served for human
consumption after the first disinfection
and flushing and follow-up samples are
taken, because when the air carrier
performs disinfection and flushing
routinely and consistently with the
manufacturer recommendations (this
includes maintaining the full contact
time of the disinfectant with the
distribution system and affording the
complete recommended flushing time)
the quality of the water system should
be returned to a total coliform-negative
result. However, after the second or
subsequent disinfection and flushing
events occur due to follow-up samples
that are total coliform-positive and E.
coli-negative, water is not permitted to
be served for human consumption
because the results confirm an on-going
microbiological occurrence problem that
warrants further action and
investigation until a set of follow-up
samples is total coliform-negative. In the
case where the water system cannot be
physically disconnected or shut-off, or
the flow of water prevented through the
taps, air carriers are required to provide
public notification to passengers and
crew, so that the public is informed of
an on-going non-fecal occurrence with
the water system. EPA believes these
changes are appropriate and public
health protection is maintained while
providing air carriers with the flexibility
needed to perform corrective actions
that meet their operational challenges.
In the proposed ADWR, corrective
actions for failing to perform a
requirement varied and were the
following:
• Failure to perform routine
disinfection and flushing would result
in air carriers providing public
notification to crew and passengers
within 24 hours after discovery of the
failure, until disinfection and flushing
occurred;
• Failure to collect routine samples
would result in air carriers providing
public notification to crew and
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17:06 Oct 16, 2009
Jkt 220001
passengers within 24 hours after
discovery of the failure, and within 72
hours disinfect and flush, and collect
follow-up samples;
• Failure to collect repeat or followup samples would result in air carriers
restricting public access within 24 hours
after discovery of the failure and
included: If the aircraft water system
cannot be shut-off, public notification
was given to crew and passengers, but
if the aircraft water system could be
shut-off, public notification was given to
crew only; and within 72 hours
disinfect and flush, and collect followup samples;
• Boarding water from a watering
point that is not approved by FDA
would result in air carriers providing
public notification to crew and
passengers within 24 hours after
boarding the water, and within 72 hours
disinfect and flush, and collect followup samples;
• Boarding water that did not meet
national primary drinking water
regulations (NPDWRs), would result in
air carriers performing all the corrective
actions as applicable to an E. coli/fecal
coliform-positive result; and
• Boarding water under any condition
where the water system was not in
compliance with the procedures
specified in the aircraft operation and
maintenance plan would result in the
air carrier providing public notification
to passengers and crew within 24 hours
of discovery of the failure, and within
72 hours disinfect and flush, and collect
follow-up samples.
In general, commenters to the
proposed ADWR stated that these
corrective actions for performance
failures were confusing and ‘‘not
commensurate with the potential health
risk,’’ they were administratively and
economically burdensome, and that
EPA should instead require the use of
‘‘intermediate and/or diagnostic
measures that allow carriers to
determine whether an actual health risk
was presented by the failure to meet the
requirement.’’ Based on the issues
raised by the commenters, EPA
determined that some changes are
needed. The final rule provides more
clarity and flexibility to aid in reducing
economic and administrative burden
while ensuring public health protection
by aligning the corrective actions based
on (1) a fecal occurrence (i.e., E. colipositive event) and failing to perform
the applicable required corrective
actions (e.g., fails to collect and submit
for analysis the follow-up samples or
boards water that that does not meet the
NPDWRs applicable to transient noncommunity water systems when there is
an E. coli-positive event); and (2) a non-
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Sfmt 4700
fecal occurrence (e.g., total coliformpositive and E. coli-negative event, or
boards water that does not meet
NPDWRs applicable to transient noncommunity water systems) and failing
to perform the applicable required
routine and/or corrective actions.
Consequently, when the air carrier
becomes aware that it has failed to
perform required routine disinfection
and flushing, or collect required routine
samples, or collect the required repeat
or follow-up samples for a total
coliform-positive and E. coli-negative
result; or boards water from a watering
point not in accordance with FDA
regulations; or boards water that does
not meet NPDWRs applicable to
transient non-community water
systems; or that is otherwise determined
to be unsafe due to non-compliance
with the procedures specified in the
operations and maintenance plan, the
air carrier must perform the corrective
actions associated with a total coliformpositive/E. coli-negative result for the
Restrict Public Access provisions:
• Within 72 hours of receipt of
discovery of the failure or after being
notified by EPA of the failure, the air
carrier must perform the Restrict Public
Access requirements until operationally
feasible to disinfect and flush, and
collect follow-up samples. Once
disinfection and flushing is performed,
and a set of follow-up samples are taken
and submitted for analysis, then the air
carrier may cease the Restrict Public
Access provisions and provide water for
human consumption from the aircraft
water system to passengers and crew. If
the follow-up sample result from this
first disinfection and flushing is total
coliform-positive and E. coli-negative,
the air carrier must perform all of the
following:
Æ Conduct the Restrict Public Access
requirements within 72 hours, and
Æ Conduct a second disinfection and
flushing and collect follow-up samples.
From the time follow-up samples are
taken, as a result of the second
disinfection and flushing, to the time of
receiving the results, air carriers must
continue all Restrict Public Access
provisions. If the second set of followup results are total coliform-positive
and E. coli-negative, then the air carrier
must continue to disinfect and flush the
aircraft water system until a set of total
coliform samples is total coliformnegative.
Æ If any follow-up sample is E. colipositive, the air carrier must follow all
the corrective actions for an E. colipositive result. These actions must
continue until a set of follow-up
samples is total coliform-negative.
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sroberts on DSKD5P82C1PROD with RULES
When the air carrier becomes aware that
it has failed to collect the required
follow-up samples due to an E. colipositive result, or boards water that does
not meet NPDWR applicable to transient
non-community water systems for an E.
coli-positive result, then the air carrier
must follow all of the E. coli-positive
corrective actions within 24 hours of
discovery of the failure or after being
notified by EPA of the failure. These
actions must continue until a set of
follow-up samples is total coliformnegative.
EPA determined that these corrective
actions are appropriate because the
ADWR relies on best management
practices (e.g., disinfection and flushing,
following operations and maintenance
plan procedures, etc.) in lieu of the
monthly total coliform sampling as
performed by stationary systems under
the Total Coliform Rule. These best
management practices are part of the
minimum requirements that ensure safe
and reliable drinking water to aircraft
passengers and crew. If an air carrier
fails to perform these minimum
requirements, then either a known
problem has not been promptly
addressed or the quality of the aircraft
water used for human consumption is in
question.
In the proposed rule, air carriers were
allowed to use water for hand washing
purposes when the water was boarded
from a watering point not approved by
FDA or when required routine
monitoring or disinfection and flushing
was not conducted. Due to re-aligned
corrective actions (as discussed earlier
in this section) that provide air carriers
with more flexibility to reduce the
economic and administrative burden of
grounding the plane to disinfect and
flush within a set timeframe, the
allowance of hand washing under these
conditions no longer apply in the final
ADWR. In addition, corresponding
changes were also made to the
applicable public notification sections
of the rule (i.e., removed reference from
the health effects language that allowed
‘‘hand washing’’ under these
conditions).
D. Restricted Access to the Water
System
EPA proposed that in any situation
where there is an affirmative indicator
of actual or potential fecal
contamination occurrence (e.g., a single
E. coli-positive sample, water that has
been boarded from a known
contaminated source or not in
accordance with FDA regulations, etc.),
the carrier would be required to restrict
access to the water system as
expeditiously as possible, but in no case
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more than 24 hours after the event
triggering the requirement (e.g., receipt
of an E. coli-positive sample result).
Ideally, under these conditions, access
to all taps used to provide water for
human consumption (e.g., galleys,
lavatories, water fountains, built in
coffee/tea makers, etc.) should be
physically disconnected or shut-off to
prevent exposure. In the proposed rule,
restrict public access included: (1)
Physically disconnect or shut-off the
water system; (2) provide public
notification to passengers and crew if
the water system cannot be physically
disconnected or shut-off, and if the
water system can be shut-off, then
public notification must be provided to
crew only; and (3) provide alternatives
to the restricted use of the aircraft water
system, such as bottled water for
drinking and coffee preparation and
alcohol-based antiseptic gels and wipes
in the galleys and lavatories, and other
feasible measures that reduce or
eliminate the need to use the aircraft
water system.
Public comments on the proposed
ADWR raised concerns over physically
disconnecting the water system and the
use of alcohol-based antiseptic gels and
wipes. With respect to physically
disconnecting the water system,
commenters stated the provision was in
conflict with FDA’s requirement to
provide food handlers with hand
washing facilities, and the provision did
not account for situations where the
water system cannot be physically
disconnected or shut-off but other
means can be used to prevent the flow
of water through taps. In response to
these comments, the final rule clarifies
the Agency’s intent to prevent passenger
and crew exposure to the water.
Therefore, EPA has adjusted the final
rule language by adding another option
to the Restrict Public Access
requirements. In the final rule, as part
of the Restrict Public Access
requirements, air carriers can use other
means to prevent the flow of water
through the taps in addition to
physically disconnecting or shutting-off
the water system. EPA believes this
change is a necessary step towards
public health protection in the event of
an actual or potential fecal
contamination occurrence. If the event
is due to a fecal occurrence, public
access restrictions must remain in-place
until the water system is disinfected and
flushed and a complete set of follow-up
samples is total coliform-negative. If the
event is due to a non-fecal occurrence,
public access restrictions must remain
in-place until the water system is
disinfected and flushed and a set of
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53601
follow-up samples is collected and
submitted for analysis. After this initial
disinfection and flushing is performed,
if any subsequent ones are needed,
public access restrictions must remain
in-place until a complete set of followup samples is total coliform-negative.
FDA requirements permit air carriers to
temporarily suspend the use of the
aircraft drinking water system during
emergencies. The ADWR provisions that
restrict public access to the aircraft
water system would be considered an
emergency situation and, therefore, do
not conflict with FDA regulations to
provide food handlers with hand
washing facilities.
In addition, due to the corrective
action changes made to better align
corrective actions based on non-fecal
and fecal occurrences, EPA adjusted the
24-hour timeframe to initiate the
Restrict Public Access requirements to
72 hours for non-fecal events. Therefore,
if an air carrier fails to perform a
requirement in the case of a non-fecal
occurrence (e.g., fails to perform a
routine disinfection and flushing), the
air carrier has 72 hours to initiate the
Restrict Public Access requirements
from discovery of the failure, or EPA’s
notification of the failure, or receipt of
the non-fecal positive result. However,
in the event of any failure to perform a
requirement in the case of a fecaloccurrence (e.g., fails to collect the
follow-up samples, or boarding water
that that does not meet NPDWRs for E.
coli), EPA did not change the timeframe
and the air carrier has 24 hours to
initiate Restrict Public Access
requirements from discovery of the
failure, or EPA’s notification of the
failure, or receipt of the fecal positive
result.
In determining whether it is
‘‘feasible’’ to physically disconnect or
shut off the water system, EPA
recognizes that in some cases carriers
may need to consider binding
operational constraints. For example, if
the water system cannot be shut off
without also shutting off water to the
toilets, a carrier may determine that
shutting off the water is not feasible and
use the alternative Restrict Public
Access provisions instead. EPA intends
to provide further guidance on this issue
in its ADWR technical guidance.
Regarding the requirement to provide
alcohol-based antiseptic hand gels or
wipes, commenters stated that it was too
limiting and did not allow for the use
of other alternative products as
specified in FDA’s monograph
governing ‘‘Topical Antimicrobial Drug
Products for Over-the-Counter Human
Use; Tentative Final Monograph (TFM)
for Health-Care Antiseptic Drug
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Products.’’ In the final rule, EPA has
changed the Restrict Public Access
provision to include any antiseptic hand
gels or wipes in accordance with FDA
regulations under 21 CFR part 333—
‘‘Topical Antimicrobial Drug Products
for Over-the-Counter Human Use.’’ In
this way, the provision evolves with
technology and new products, and
maintains consistency with FDA
regulations regarding these products.
E. Response to Proposed Rule Requests
for Comment
sroberts on DSKD5P82C1PROD with RULES
1. Microbiological Indicators
In the proposed ADWR, EPA
requested specific comment on whether
bacterial presence measured by
heterotrophic plate count (HPC) should
be allowed, required, or not considered
as an indicator of water quality in
addition to total coliform monitoring.
One commenter responded that HPC
should be allowed as an indicator of
water quality in addition to total
coliform monitoring. However, several
commenters responded that HPC is not
a reliable indicator in aircraft water
systems, that the sample holding time
between collection and analysis of six
hours if the sample is unrefrigerated is
impractical, and that it provides no
additional benefit justifying the
regulatory burden of conducting HPC
sampling. EPA agrees with commenters
that the use of HPC in the ADWR is
impractical due to the restrictions on
sample holding times and the
limitations of the information the HPC
test results would provide. Therefore,
today’s rule does not require HPC
monitoring. Additionally, HPC testing is
used as a surrogate for disinfectant
residual testing for stationary systems
and since disinfectant residual testing is
not an ADWR requirement, HPC testing
is unnecessary under the ADWR.
2. Potential for Bacterial Growth
EPA requested specific comment on
whether the final rule should include
provisions to address extended periods
during which the aircraft water would
remain stagnant, experience high water
temperatures, or other situations that
may contribute to concern regarding
bacterial growth. Although most aircraft
water tanks are either topped off or
drained on an almost daily basis,
occasional situations occur when the
water may sit stagnant for an extended
period of time or otherwise not be
turned over, and thus could be at risk
for biofilm development or other
bacterial growth. EPA received several
public comments both in favor of and
opposed to regulatory requirements for
dealing with extended stagnant periods,
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or other situations that may be of
concern regarding bacterial growth.
Commenters in favor of such provisions,
in general, agreed with EPA’s analysis of
the potential for bacterial growth. The
comments ranged from stating that the
provisions should be data-driven to
‘‘The Agency should confirm the
effectiveness of disinfection and
flushing in eliminating contaminants
and biofilm by evaluating all aspects of
closed circulation, airline water
systems.’’ Commenters opposed to the
requirements raised two main concerns:
(1) Aircraft do not have the current
means to measure the temperature of the
water in the storage tank and retrofitting the aircraft to do this would be
an immense project, economically and
logistically, for air carriers and
manufacturers; and (2) Air carriers
already implement procedures that
guard against the risk of bacterial
growth such as draining, disinfecting,
and flushing the water tanks if the
aircraft has been out-of-service for
extended lengths of time. Based on
these collective comments, the final rule
does not include provisions to address
extended stagnant periods, high water
temperatures, or other situations that
may augment concern for bacterial
growth. Instead, EPA plans on
addressing these issues in its ADWR
technical guidance.
3. Temperature of Water From Sample
Taps
EPA requested specific comment on
whether sampling should only be
limited to cold water taps when they are
available. EPA also requested comment
on whether or not, in the event that a
sample is taken from a hot water tap, the
temperature should also be measured to
provide some indication of whether the
temperature achieved is high enough to
alter the microbiological results. EPA
received several comments both in favor
of and opposed to sampling only from
cold water taps and measuring the
temperature of water collected from hot
water taps. The comments ranged from
(1) the ADWR should include collecting
samples from both cold water as well as
hot water taps, and taking the
temperature of water from hot water
taps does not provide an accurate
measurement of microbiological
safeness, to (2) sampling should be from
taps that are most representative of the
water consumed by passengers which,
in many cases, comes from galleys that
are only equipped with hot water taps.
Also, a commenter indicated that it
would be impractical to set ‘‘minimum
temperature’’ requirements that apply to
‘‘all hot water taps not only because of
the variety of aircraft in service, but also
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the effect that altitude has on [water]
temperatures. On the ground, where
sampling will occur, a tap would
register a different temperature than it
would at an aircraft’s cruising altitude,
which is when that tap is most likely to
be used to serve coffee/tea.’’
EPA agrees that sample locations
should be those most representative of
water used for human consumption by
passengers and crew. However, since
there is a potential for the temperature
in the hot water taps to kill existing
microorganisms, and this might mask
whether there is a microbiological
problem in the aircraft system, samples
should be taken from cold water taps
when they are available, except e.g., in
the case when only a hot water tap is
available in the galley. In this case, the
galley sample should be taken from the
hot water tap. In addition, EPA plans to
further discuss tap sampling in its
ADWR technical guidance.
4. Statistical Sampling of an Air Carrier
Fleet
EPA requested specific comment on
the use of statistical sampling
methodologies, specifically on what
type of monitoring scheme would allow
a statistical sample to be representative
of an entire air carrier fleet. EPA was
especially interested in receiving input
on whether such methodologies, if
allowed, should only be used in
conjunction with onboard or other
supplemental treatment, such as adding
a chemical disinfectant or ultraviolet
light. EPA also requested input
regarding the support for such an
option, given the cost and logistical
implications a positive coliform result
would have on the statistical sample by
triggering follow-up action in the entire
fleet. The majority of the public
comments were in favor of statistical
sampling, but they did not provide any
examples of a statistical method or data
to support their position. In opposition
to statistical sampling, a commenter
expressed concern over the use of
statistical sampling because of the
variability of the quality of the water
that could be boarded from various
sources, and because, ‘‘when blended,
all of the chemical and microbiological
parameters would change and data
generated would become inaccurate.’’
One commenter in favor of statistical
sampling stated that EPA should allow
the use of statistical sampling because
there was substantive evidence that
aircraft in a fleet, or a subset of a fleet,
behaved similarly with respect to
avoiding positive tests for total
coliforms. However, new data beyond
the AOCs’ data was not provided to
support this statement, and the AOCs’
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data are not sufficiently robust to
support such an analysis. Another
commenter suggested that statistical
sampling could be used to minimize the
sample collection volumes and
frequency; however, no sampling
scheme or data was provided. Yet
another commenter suggested EPA
incorporate into the rule the allowance
of a procedure whereby an individual
carrier could propose a statistical
sampling method, present a proposed
program for doing so along with
technical analyses demonstrating its
representativeness and efficacy, and
request EPA to review and approve the
plan.
Today’s rule does not include
provisions for statistical sampling
because EPA did not receive data to
change its opinion that sampling a
fraction of aircraft water systems does
not identify all of the aircraft that may
be operating with a contaminated water
system. Therefore, the potential still
exists that the un-sampled aircraft may
be operating with a contaminated water
system, possibly for years, until it is
randomly selected and tested. EPA
considers that its approach is
appropriate, because each aircraft water
system is a unique system that may
board water from a potentially large
number and variety of sources and
distribution systems, and the volume of
water that is boarded may vary on a
daily basis or more often. Under current
practices, the sources of water for an
individual aircraft are so varied, in
addition to variability in the quality of
operation and maintenance practices, it
would be difficult for a statistical
sample to provide an accurate
representation of all water being served
on an air carrier’s fleet. In addition, the
majority of the committee members of
EPA’s Science Advisory Board (SAB)
were not in favor of statistical sampling
of aircraft drinking water because the
available data is too sparse to interpret
results for the whole fleet. As a result,
the final rule does not allow for
statistical sampling.
5. Option for Repeat Sampling
EPA requested specific comment on
whether to disallow the option for
repeat sampling in response to a routine
total coliform-positive sample if the
aircraft has boarded water since the
routine sample was taken. EPA noted
that 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 received comments
that were both in favor of and opposed
to disallowing the option for repeat
sampling in response to a routine total
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coliform-positive sample. Commenters
in favor of repeat sampling noted that it
was a reliable method of investigating
the extent of bacterial problems in the
water system, and another commenter
stated that it allows an air carrier to
pinpoint a source of contamination and
should be permitted. In opposition to
repeat sampling, a commenter noted
that it should not be allowed because
the process takes several days, which
extends the time period for passengers
and crew to be exposed to a potential
health risk. In today’s rule, EPA
maintains the option to collect repeat
samples as a corrective action to a total
coliform-positive routine sample that is
E. coli-negative. EPA believes repeat
sampling is a valuable option because it
can indicate whether the problem
reflected by the routine sample result is
no longer present, or whether the
problem has persisted and requires
further corrective action; therefore, EPA
is allowing the option for repeat
sampling in response to a routine total
coliform-positive sample that is E. colinegative in this ADWR.
6. Disinfectant Residual Monitoring
EPA requested specific comment on
whether it is appropriate to require
monitoring of routine disinfectant
residuals and if so, the frequency for
monitoring and the corrective action
required if sufficient disinfectant
residuals are not detected. EPA received
approximately the same number of
comments in favor of and opposed to
adding a requirement for routine
monitoring of a disinfectant residual. In
favor of monitoring for disinfectant
residuals, a commenter stated that flight
attendants should be trained in the use
of chlorine residual testing equipment,
and that the rule should maintain the
AOCs’ disinfectant residual monitoring
requirements, because having a
detectable residual is effective against
bacterial growth. Commenters who
opposed routine monitoring of a
disinfectant residual thought that (1) it
was unnecessary and does not provide
a meaningful representation of risks or
system integrity; (2) since air carriers
receive finished water from PWSs, the
level of disinfectant residual in the
water supply is outside of the control of
the air carriers; meaning, there is no
benefit to requiring the carriers to
monitor for disinfectant residual since
the air carriers cannot take action to
increase it on a system-wide basis; and
(3) since water turns over very quickly
in aircraft water systems, monitoring of
residual disinfectant provides no added
benefit.
The final rule does not require
monitoring of a disinfectant residual for
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several reasons. First, the Surface Water
Treatment Rule requires public water
systems using surface water as a source
to maintain a detectable disinfectant
residual in the distribution system to
ensure that disinfection is maintained
throughout the water system. If a
stationary system has a non-detectable
disinfectant residual it may increase the
amount of disinfectant added at the
treatment facility, routinely flush water
from dead-end or low water use areas of
the distribution system, or add
additional disinfection to a specific area
of the system by installing boosterdisinfection equipment to increase the
disinfectant residual. Adding
disinfectant booster equipment is not
practicable or feasible for aircraft water
systems due to tank design challenges.
In addition, any corrective action
requiring manual addition of water with
a disinfectant residual would result in
major disruptions to flight schedules
(e.g., to drain and refill or flush and
disinfect the aircraft water tank).
Second, since aircraft may board water
more than once per day from a variety
of sources, some of which may be
groundwater that is not disinfected, EPA
is uncertain whether monthly (or less
frequent) disinfectant residual
monitoring would provide useful
information for aircraft water systems.
At the same time, EPA believes that
more frequent flushing and disinfection
of the entire aircraft water system as a
treatment technique combined with
other barriers incorporated into the
ADWR (e.g., operations and
maintenance plans, etc.) will ensure that
microbiologically safe tap water is
provided on the aircraft even without
the residual disinfectant requirements
applicable to stationary public water
systems. Finally, the rule specifies that
aircraft water systems are to board only
finished water (i.e., drinking water
intended for distribution and
consumption without further treatment).
Therefore, it is the responsibility of the
PWS from which the aircraft receives
water to provide finished water that
meets all the NPDWRs. Under the
NPDWRs, if that PWS uses groundwater
as its ambient source, then the finished
water is not required to have a
detectable disinfectant residual. Trying
to determine if boarded water is
required to have a disinfectant residual,
and then trying to correct it if
monitoring yields a non-detectable
disinfectant residual result, would be an
economic and operational burden for
the air carrier.
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7. Timeframe for Disinfection and
Flushing
EPA requested specific comment on
the appropriateness of the 72-hour
timeframe to disinfect and flush, upon
receipt of two total-coliform-positive
sample results or a single fecal coliformor E. coli-positive result, since
disinfection and flushing requires taking
the aircraft out-of-service to a
designated maintenance facility. The
majority of the public comments
received favored the 72-hour timeframe
with some concerns. For example, one
commenter expressed that the
timeframe is a ‘‘sensible’’ and necessary
response, but such unscheduled
activities will be costly and burdensome
to the air carriers and create an
unfavorable reaction from passengers to
the restricted access to the water and
flight delays. On the same note, another
commenter stated that the 72-hour
timeframe is appropriate under normal
conditions; however, in situations
where weather or other airspace system
delays renders compliance with the 72hour timeframe impractical, the Agency
should provide an extension to 96
hours. Another commenter noted
‘‘while in the abstract’’ the timeframe
appears to be achievable, the Agency
needs to provide ‘‘reasonable
accommodation for scheduling’’ in cases
where the air carrier may receive sample
results while the aircraft is overseas and
is unable to return to the U.S. and to the
maintenance facility in 72 hours. EPA
recognizes that its proposed timeframe
of 72 hours has the potential to disrupt
some passenger services, and may cause
logistical challenges such as receiving
results while on an international route.
Therefore, the final rule includes an
optional corrective action intended to
provide air carriers with more
disinfection and flushing flexibility
when routine and/or repeat coliform
samples are total-coliform-positive but
E. coli-negative. The option in the final
rule allows the air carrier to perform the
Restrict Public Access requirements
within 72 hours of learning of the total
coliform-positive result(s) that is E. colinegative and conduct disinfection and
flushing when it is operationally
feasible. If the air carrier performs the
Restrict Public Access Requirements, it
does not have to disinfect and flush the
aircraft in 72 hours, even if the aircraft
water system cannot be physically
disconnected or shut off, or the flow of
water prevented through the taps. This
option allows an air carrier to avoid
service disruptions. The air carrier must
collect follow-up samples prior to
providing water for human
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consumption from the aircraft water
system.
The presence of total coliforms only
(when no E. coli is detected) presents a
non-fecal potential health risk and is an
indication of poor water quality. Since
the water is of poor quality, the
passengers and crew have a right-toknow. Hence, public notification is an
emphasized component of this option.
However, EPA considers an E. colipositive result to be an acute potential
fecal health risk, and it is a necessary
public health measure to ground the
plane in 72 hours when the water
system cannot be physically
disconnected or shut-off, or the flow of
water prevented through the taps.
Therefore, no changes were made in the
final rule to the corrective actions for E.
coli-positive results.
8. Supplemental Treatment
EPA requested specific 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. In addition,
EPA requested 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. EPA
received public comments both for and
against the required use of supplemental
treatment. Concern was expressed that
supplemental treatment would increase
costs for installation, extra weight,
maintenance, and revision of aircraft
operation and maintenance programs to
accommodate a system that was not a
part of the aircraft manufacturer’s final
product. Comments in support of
supplemental treatment indicated that it
may be viewed as the ultimate barrier
against the risk of illness due to
contaminated drinking water, and that
there could be economic savings
associated with reduced monitoring,
reduced routine disinfection and
flushing of aircraft water systems, and
reduced remedial activity due to fewer
positive test results. In addition, the
commenter expressed that supplemental
treatment could possibly reduce or
eliminate the need for bottled water.
In the final ADWR, supplemental
treatment is not required to be used
with finished water that has been
boarded on the aircraft. EPA believes it
has prescribed the minimum
requirements necessary to provide safe
drinking water to passengers and crew
onboard aircraft, including the
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requirement to board finished water.
However, supplemental treatment can
provide an additional barrier of
protection in the event of a failure in
any of the basic protection barriers
required under this rule (e.g., boarding
finished water in accordance with FDA
requirements; transferring the water
from the watering point to the aircraft in
a manner that ensures it will not
become contaminated during the
transfer; appropriate training of
personnel; implementation of a water
system operation and maintenance plan;
etc.).
EPA believes the basic requirements
of the ADWR, when performed
consistently and diligently by the air
carriers and their agents, provide
assurance that drinking water onboard
aircraft is safe for passengers and crew.
Based on the information that EPA has
at the time of this rulemaking, there is
not sufficient information or data to
support a requirement of supplemental
treatment for aircraft water systems or
for reducing any of the minimum
requirements based on the installation
of supplemental treatment. However,
EPA plans to revisit this issue as part of
the Six-Year review of this rule under
SDWA section 1412(b)(9) and as more
data become available. EPA also plans
to address supplemental treatment
issues in its ADWR technical guidance.
9. Recording the Boarding of Water
EPA requested specific comment on
whether the potential benefit of
recording information of where, how
much, and when water is boarded
outweighs the information collection
burden. The boarding of water is usually
done on an as-needed and as-requested
basis, and EPA is not aware of any
current requirements for capturing this
type of information. EPA received
public comments both for and against
recording the information (e.g., where,
how much, and when water is boarded).
One commenter stated that this
information may be helpful in
determining the cause of contamination
events. Another commenter noted that
requiring carriers to record this
information would increase delays and
costs. EPA has not received sufficient
information or data that show a benefit
to recording information on the
boarding of water that would justify the
additional recordkeeping burden on the
air carrier. A single aircraft may board
water several times a day from multiple
airports. During the boarding of water,
water from more than one source is
usually commingled in the aircraft
water system since the tanks may not be
completely drained between fillings.
Maintaining a log of this information
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may not necessarily help in identifying
the source of contamination of an
aircraft water system because there
could be multiple causes for
contamination of such systems.
Requiring a log would generate multiple
daily records for each aircraft without a
known health benefit. Consequently, the
final rule does not require recording
information of where, how much, and
when water is boarded.
10. Follow-Up Sampling To Confirm the
Effectiveness of Routine Disinfection
and Flushing
EPA requested specific comment on
whether follow-up sampling should be
required to confirm the effectiveness of
routine disinfection and flushing, and if
so, the frequency/number of samples by
which this monitoring should occur.
EPA received comment in favor of and
against requiring follow-up sampling
after routine disinfection and flushing.
A comment in favor of a requirement
specifically noted, ‘‘follow-up sampling
should be required to confirm the
effectiveness of routine disinfection and
flushing, at least until a body of
evidence can be established that clearly
indicates that routine disinfection and
flushing is reliably effective in removing
biofilm from the aircraft water system.’’
Another commenter believed, ‘‘Once the
aircraft has been disinfected and
flushed, it may be necessary to test the
water (again) to be sure that the
disinfection has been successful and
any problem of bacterial contamination
has been solved. Sampling immediately
after the disinfection and flushing may
not show any hidden contamination
problems. Hence, it is very important to
wait a minimum time requirement (7–10
days) after disinfecting in order to recommence the regular water testing
regime.’’ A commenter against such
follow-up sampling as a regulatory
requirement noted the following
concerns: (1) It would be ‘‘inconsistent
with and undermine the [routine]
disinfection and monitoring frequency
schedules’’; (2) ‘‘Inasmuch as routine
disinfection does not involve evidence
of a system problem, but is simply a
preventative measure, there is no riskbased benefit to post-disinfection
routine sampling’’; (3) it would ‘‘impose
significant logistical and cost burdens
on the airlines and unduly delay the
return of aircraft to service while
sampling results were processed’’; and
(4) ‘‘Imposing additional sampling costs
would be arbitrary and unreasonable in
situations that do not suggest any
compromise of system integrity, but
rather are routine measures.’’
As discussed in the proposed rule,
EPA established that, to ensure the
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results of routine samples are not
inadvertently skewed by sampling too
close to a disinfection event, routine
coliform samples must not be collected
within 72 hours after completing
routine disinfection and flushing
procedures. Collecting a coliform
sample within 72 hours of routine
disinfection and flushing is not
representative of the general conditions
of the aircraft water system. This
required 72-hour time interval has not
been changed in the final rule. However,
EPA does agree that such follow-up
samples do aid in determining the
success of disinfection and flushing,
and encourages additional or special
coliform sampling. Today’s rule does
not require follow-up sampling to
confirm the effectiveness of routine
disinfection and flushing. EPA has not
received sufficient information or data
that show that such monitoring is
necessary, and believes spacing routine
samples evenly across monitoring
periods is more representative of aircraft
drinking water quality and normal
aircraft water system operations.
F. Aircraft Water System Operations
and Maintenance Plan (§ 141.804)
Both the proposed rule and today’s
final rule require each air carrier to
develop and implement an aircraft
water system operations and
maintenance plan for each aircraft water
system operated by the air carrier. The
air carrier need not develop a separate
plan for each aircraft, but the air carrier
must ensure that each aircraft it owns
and operates is covered by a plan. For
example, if the air carrier operates
several of the same type of aircraft with
the same type of water system, the air
carrier may choose to develop one
operations and maintenance plan that
applies to aircraft of this type in its fleet.
In the proposed rule, air carriers
would be required to include the aircraft
water system operations and
maintenance plans in a Federal Aviation
Administration (FAA)-approved or
-accepted air carrier operations and
maintenance program. The Agency
received several public comments
against including this requirement in
the final rule. Commenters expressed
concern that this cast FAA in an
inappropriate regulatory role, and that
inclusion of the aircraft water system
operations and maintenance plans in a
FAA-approved or -accepted air carrier
operations and maintenance program
could cause significant reworking of
existing maintenance program
documents and may cause a duplication
of effort in terms of regulatory oversight.
EPA disagrees with these comments
and continues to believe that including
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the aircraft water system operations and
maintenance plans in a FAA-accepted
air carrier operations and maintenance
program is a critical element of the final
rule. FAA views proper operation and
maintenance of the water system as an
operational safety issue and agrees with
EPA that it is appropriate to have the
water system operations and
maintenance plans included in the
FAA-accepted operations and
maintenance program. FAA requires all
maintenance and operational
procedures to be formally documented
for each aircraft, and a failure by an air
carrier to perform the prescribed
program requirements may result in
forfeiture of air carrier operating
certificates and/or fines. In addition,
properly integrating aircraft water
system operations and maintenance
procedures with other FAA-accepted
operations and maintenance procedures
is the most reliable way to ensure
effective implementation of the plan
and maximize effective oversight by
EPA and FAA. This will help to
minimize duplication of effort by the
two agencies.
Though this requirement remains in
the final rule, the Agency made one
minor change to the language in this
paragraph. Since the publication of the
proposed rule, the Agency has learned
that FAA does not ‘‘approve’’ the air
carrier operations and maintenance
programs, and that describing these
programs as ‘‘FAA-accepted’’ programs
is more accurate. Thus, the final rule
requires that air carriers include the
aircraft water system operations and
maintenance plan in an FAA-accepted
operations and maintenance program.
In the proposed rule, EPA proposed to
allow air carriers only six months to
develop an aircraft water system
operations and maintenance plan for
each existing aircraft. However, the
Agency received several comments
requesting that the compliance date be
extended in order to allow for more time
for air carriers to restructure
maintenance programs between the
AOCs and the final rule. The comments
and the Agency’s response are
explained in more detail in section IV.L
of this notice. EPA agrees that more time
may be needed for air carriers to
develop aircraft water system operations
and maintenance plans for existing
aircraft. Therefore, today’s final rule
extends the compliance date for
development of the aircraft water
system operations and maintenance
plan for existing aircraft from six
months to 18 months after publication
of the final rule.
The Agency also received comments
that the proposed rule was unclear as to
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whether and how air carriers could
amend their operations and
maintenance plans or their coliform
sampling plans. EPA agrees that the
final rule should more clearly state the
requirements for making changes to
these plans. Thus, in the final rule, EPA
addresses this concern by clarifying that
any subsequent changes to the aircraft
water system operations and
maintenance plan must also be included
in the FAA-accepted air carrier
operations and maintenance program.
For example, changes to the aircraft
water system operations and
maintenance plan could include, but are
not limited to, changes to the
procedures for disinfecting and
flushing, including changes to the
routine disinfection and flushing
frequency, changes to training
requirements, changes to self-inspection
procedures, or changes to procedures for
boarding water. The reporting
requirements and the requirements for
the coliform sampling plan have also
been revised to respond to these
comments.
The following is a discussion of
elements of the aircraft water system
operations and maintenance plan for
which EPA received comment and/or
made changes to the final rule.
The proposed rule would require that
the operations and maintenance plan
ensure all water boarded within the
United States is from an FDA-approved
watering point as required under 21
CFR 1240.80. The Agency received
several comments on this requirement.
Some commenters believed that EPA
intended this requirement to alter FDA
regulations applicable to watering
points. The commenters also pointed
out a possible inconsistency with this
requirement and existing FDA
regulations for watering points.
The Agency continues to
acknowledge the joint oversight role of
EPA and FDA in ensuring safe drinking
water on aircraft. Therefore, this
requirement does not seek to change any
of FDA’s regulations regarding watering
points. Rather, EPA continues to defer
to FDA with respect to regulating
watering points. FDA will continue to
ensure that the water supply meets the
standards prescribed in EPA’s NPDWRs,
and ensure the methods of delivery,
facilities for delivery, and the sanitary
conditions surrounding the delivery of
water to the aircraft in order to prevent
the introduction, transmission, or
spread of communicable diseases.
Therefore, EPA revised the final rule to
clearly communicate the Agency’s
intent. The final rule requires that all
watering points must be selected in
accordance with FDA regulations (21
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CFR part 1240, subpart E). Today’s final
rule also requires that the operations
and maintenance plan include
procedures for ensuring that the air
carrier board water from a watering
point in accordance with FDA
regulations (21 CFR part 1240, subpart
E). These changes remove any
inconsistency between the final rule and
existing FDA regulations. It also ensures
that all FDA regulations regarding
watering points, including those
applicable to watering points permitted
for temporary use, are referenced in the
final rule.
The proposed rule stated that in no
event must air carriers knowingly serve
water that violates the NPDWRs. It also
provided that if it was necessary to
board water that violated the NPDWRs,
the air carrier must perform the
corrective action requirements
applicable to E. coli-positive coliform
sample results. Today’s final rule
clarifies that in no event must air
carriers knowingly provide water for
human consumption that violates the
NPDWRs applicable to transient noncommunity water systems. The Agency
understands that sometimes unsafe
water must be boarded in order to
operate other essential systems, but at
no time are air carriers to provide such
water to passengers and crew in the
form of beverages (e.g., coffee, tea, etc.);
nor may passengers and crew be
allowed access to the water system (i.e.,
the water system must be shut-off or the
flow of water prevented through the
taps); nor may the water be used for
food preparation or any other
consumptive use.
The proposed rule would require that
the operations and maintenance plan
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 FDAapproved or otherwise safe watering
point. In the final rule, EPA continues
to require that the operations and
maintenance plan include a description
of emergency procedures to be used in
the event that unsafe water is boarded
to operate essential systems. In today’s
final rule, the operations and
maintenance plan must include a
description of emergency procedures
used when the air carrier becomes
aware that unsafe water is boarded.
Unsafe water includes:
• Water boarded from a watering
point not in accordance with FDA
regulations;
• Water that does not meet NPDWRs
applicable to transient non-community
water systems; or
• Water that is otherwise determined
to be unsafe due to non-compliance
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with the procedures for boarding water
specified in the operations and
maintenance plan.
G. Notification Requirements to
Passengers and Crew (§ 141.805)
1. Situations Requiring Public
Notification
In EPA’s proposed rule, public
notification would be required in the
following situations: (1) Where access to
the aircraft water system is required to
be restricted (e.g., fecal coliform/E. colipositive sample result); (2) where there
was a failure to collect required
samples; (3) 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; or (4) in any other
situation where the Administrator, air
carrier, or crew determines that
notification is necessary to protect
public health.
The Agency received several
comments that prompted EPA to make
changes to the situations described in
the proposed rule. Some of the changes
were a result of comments directly
related to the public notification
requirements of this section, while other
changes were a result of comments
applicable to other sections of the rule
which subsequently affected these
public notification requirements.
First, in the final rule, the Agency
restructured the corrective action
requirements in § 141.803 in response to
comments discussed previously. Under
the final corrective action provisions,
public notification not only applies to
an E. coli-positive sample result, but
also when an air carrier chooses to
restrict public access in response to a
sample result that is total coliformpositive and E. coli-negative, and failure
to perform required ADWR provisions.
Second, the Agency received
comments stating that the situations
requiring notification listed in the
proposed rule in § 141.810 (i.e.,
Violations) conflict with the situations
listed in proposed § 141.805 (i.e.,
Notification of passengers and crew).
The comments suggested that to avoid
confusion and inconsistency, EPA
should delete the public notification
requirements in § 141.810 or make
conforming changes to the two sections.
EPA agrees that the reference to public
notification requirements in § 141.805 is
confusing and inconsistent with
§ 141.810. Therefore, EPA removed all
references to public notification from
§ 141.810 and made conforming changes
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to § 141.805 of the final rule. As a result,
air carriers are now required to give
public notification when there has been
a failure to perform required routine
disinfection and flushing; or failure to
collect routine, repeat or follow-up
samples; or a failure to perform a
corrective action associated with a fecal
occurrence event.
Third, the Agency received several
comments on the watering point
selection requirement and the
requirement to board water from FDAapproved watering points in § 141.804.
These comments and EPA’s response
are discussed elsewhere in today’s
notice. As a result, the Agency clarified
both of these requirements in § 141.804
of the final rule, and made the following
changes under which air carriers must
provide public notification when the air
carrier becomes aware that the quality of
water cannot be assured:
• Where water has been boarded from
a watering point not in accordance with
FDA regulations;
• Where water that has been boarded
does not meet NPDWRs applicable to
transient non-community water
systems; and
• Where water is otherwise
determined to be unsafe due to noncompliance with the procedures
specified in § 141.804(b)(6).
sroberts on DSKD5P82C1PROD with RULES
2. Method of Notification Delivery
Both the proposed rule and today’s
final rule require that air carriers
provide notification in a form and
manner reasonably calculated to reach
all passengers and crew. Using a variety
of delivery methods for these
notifications will help ensure that all
passengers, including those with visual
or hearing impairments, or non-English
speakers, will have access to relevant
public health information.
3. Cessation of Public Notification
The proposed rule would require that
all public notification continue until all
follow-up samples are total coliformnegative. As a result of clarifications
made to the corrective action
requirements in § 141.803 of the final
rule, EPA also clarifies that an air carrier
must continue to provide public
notification until the aircraft water
system is returned to unrestricted public
access.
For instance, when the initial
corrective action disinfection and
flushing is conducted in response to a
routine total coliform-positive sample
result that is E. coli-negative, or there is
a failure to perform required actions as
a result of non-fecal events, public
notification may cease when the aircraft
water system is disinfected and flushed
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and follow-up samples have been
collected. At this time, the water system
may be returned to unrestricted public
access; however, when corrective action
disinfection and flushing is conducted
more than once (i.e., disinfection and
flushing is conducted in response to a
follow-up sample that is total coliformpositive and E. coli-negative), public
access restrictions, including public
notification, must remain in-place until
a later set of follow-up samples is total
coliform-negative.
If initial corrective action disinfection
and flushing is conducted as a result of
an E. coli-positive sample result, or a
failure to perform required actions as a
result of fecal events, public access
restrictions, including public
notification, must remain in-place until
a complete set of follow-up samples is
total coliform-negative (not just until
they are collected and sent for analysis,
as in the case where the corrective
action is triggered by a total coliformpositive but E. coli-negative sample).
In both cases, when public access is
restricted due to an E. coli-positive
sample or a total coliform-positive
sample that is E. coli-negative, if the air
carrier can shut off the water system or
restrict the flow of water through the
taps, then public notification need only
be conducted for the crew and not to the
passengers.
4. Type of Notice Required When Public
Access Is Restricted
Commenters noted that the public
notification requirements in the
proposed rule were confusing, and it
was difficult to determine which
requirements were applicable in
situations where public access was
restricted. In the final rule, the Agency
better aligns the public notification
requirements based on three categories:
sample results (i.e., a total coliformpositive and E. coli-negative result or an
E. coli-positive result), non-fecal
occurrence failures and events (e.g.,
failure to conduct repeat sampling), and
fecal occurrence failures and events
(e.g., failure to collect follow-up
samples after the aircraft water system
tests positive for E. coli, or the air carrier
becomes aware that E. coli-positive
water was boarded from a watering
point not in accordance with FDA
regulations, etc.).
In today’s rule, EPA makes clear for
all three public notification categories
that if the aircraft water system can be
physically disconnected, shut-off, or the
flow of water is prevented through the
taps, air carriers are required to provide
public notification to the crew only.
However, if the aircraft water system
cannot be physically disconnected,
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Fmt 4701
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53607
shut-off, or the flow of water cannot be
prevented through the taps, air carriers
are required to provide public
notification to passengers and crew.
This is allowable for all three public
notification categories.
In addition, today’s rule requires that
when an air carrier becomes aware that
unsafe water was boarded, the public
notice must include when and where
the unsafe water was boarded. For the
purpose of this requirement, unsafe
water includes water that was boarded
from a watering point not in accordance
with FDA regulations (21 CFR part 1240
subpart E), or water that does not meet
NPDWRs applicable to TNCWSs, or
water that is otherwise determined to be
unsafe due to non-compliance with the
procedures specified in § 141.804(b)(6).
5. Standard Health Effects Language
Due to the removal of fecal coliforms
as a fecal indicator (as discussed in
section IV.C Responses to Sample
Results), all references to ‘‘fecal
coliforms’’ have been removed from the
health effects language. In addition, in
order to better align the health effects
language in § 141.805 to the restructured
corrective action requirements in
§ 141.803, the Agency clarified that
there is specific health effects language
applicable when public notification is
triggered by an E. coli-positive sample
result, a sample result that is total
coliform-positive and E. coli-negative, or
a non-fecal occurrence failure or event.
In addition, new health effects language
was added when public notification is
triggered by a fecal occurrence failure or
event.
The specific health effects language
was also revised to conform to revisions
to § 141.804. In the final rule, the
watering point statement reads, ‘‘Water
was boarded from a watering point not
in accordance with FDA regulations,’’
rather than, ‘‘Water was boarded from a
watering point not approved by FDA.’’
H. Reporting Requirements (§ 141.806)
EPA proposed that air carriers report
the following to the Administrator
within six months of publication of the
final rule in the Federal Register:
• That a coliform sampling plan was
developed for each existing aircraft;
• The frequency for routine coliform
sampling identified in the coliform
sampling plan developed for each
existing aircraft; and
• That an operations and
maintenance plan was developed for
each existing aircraft.
The Agency received several
comments requesting that the
compliance date be extended in order to
allow for more time for air carriers to
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restructure maintenance programs
between the AOCs and the final rule.
EPA agrees that more time may be
needed for air carriers to comply with
these reporting requirements. Therefore,
today’s rule requires that air carries
comply with these requirements 18
months after publication of the final
rule. The comments and the Agency’s
response are explained in more detail in
section IV.L of this notice.
EPA proposed that air carriers report
a complete inventory of aircraft that are
public water systems within six months
of publication of the final rule.
However, the Agency received several
comments requesting that this
compliance date be extended. EPA
agrees that more time may be needed for
air carriers to report a complete
inventory of aircraft that are public
water systems. Therefore, today’s final
rule extends the compliance date for
development and reporting of the
inventory to 18 months after publication
of the final rule. The comments and the
Agency’s response are explained in
more detail in section IV.L of this
notice.
The Agency received comments
requesting clarification on the aircraft
inventory requirement to report changes
in an aircraft’s status from active to
inactive or vice versa. In the final rule,
EPA clarifies that active or inactive
status refers to the aircraft’s status as an
aircraft water system. Thus, an aircraft
that meets the definition of an aircraft
water system is considered ‘‘active,’’
while one that does not meet this
definition is considered ‘‘inactive.’’ For
example, an aircraft may be considered
‘‘inactive’’ in situations where an
aircraft is out of passenger service for
extended maintenance, or where an
aircraft is in passenger service, but
flying strictly international routes where
SDWA does not apply. Therefore, in the
final rule, the Agency clarifies that air
carriers must report, no later than 10
days following the calendar month in
which the change occurred, the status,
or the change in status, of any aircraft
as an aircraft water system as defined in
§ 141.801.
In addition, EPA corrects the final
rule by adding § 141.806(b)(2)(iv). This
paragraph requires air carriers to report
changes in the ability to physically shut
off or disconnect the water system. This
requirement was referred to in the
preamble of the proposed rule, but
omitted from the rule text. Restoring
this requirement to the rule eliminates
the inconsistency.
The Agency received comments that
the proposed rule was unclear as to
whether and how air carriers could
amend their operations and
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17:06 Oct 16, 2009
Jkt 220001
maintenance plans or their coliform
sampling plans. In the final rule, EPA
addresses this concern by amending the
final rule in several places, including by
adding paragraph § 141.806(b)(6). This
paragraph requires that the new
frequency be reported to the
Administrator no later than 10 days
following the calendar month in which
the change occurred. It also requires that
these changes be included in the aircraft
water system operations and
maintenance plan that is included in the
air carrier operations and maintenance
program accepted by FAA.
In the proposed rule, the Agency
noted for each aircraft water system the
air carriers must include the routine
disinfection and flushing frequency in
the operations and maintenance plan,
and air carriers must keep records of
disinfection and flushing events.
However, the Agency did not
specifically note under § 141.806 that
disinfection and flushing events must be
reported to the Administrator. Since the
Agency’s intent included reporting
disinfection and flushing events to the
Administrator, the following was added
to § 141.806 Reporting Requirements for
consistency and clarification:
• For each existing aircraft water
system, the air carrier must report to the
Administrator the frequency for routine
disinfection and flushing by 18 months
after the final rule is published.
• For each new aircraft water system,
the air carrier must report the frequency
for routine disinfection and flushing,
within the first calendar quarter of
initial operation of the aircraft.
• Routine disinfection and flushing
events must be reported no later than 10
calendar days following the disinfection
and flushing period in which the
disinfection and flushing occurred (e.g.,
quarterly, semi-annually).
• Changes to the disinfection and
flushing frequencies must be reported
no later than 10 days following the
calendar month in which the change
occurred.
In addition, the final rule further
clarifies the Agency’s intent to require
reporting of all events that require nonroutine sampling.
I. Recordkeeping Requirements
(§ 141.807)
In both the proposed rule and today’s
final rule, EPA requires that air carriers
retain certain information for the aircraft
water systems that they own or operate.
The following is a discussion of
recordkeeping requirements for which
EPA received comment and/or made
changes to the final rule.
In the proposed rule, the Agency did
not specify the types of records related
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Frm 00020
Fmt 4701
Sfmt 4700
to disinfection and flushing and selfinspections that must be kept in order
to meet the recordkeeping requirements.
One commenter suggested that air
carriers be required to ‘‘keep records
confirming performance of required
disinfection’’ and ‘‘keep records
confirming performance of selfinspections.’’ In general, the commenter
stated that requiring air carriers to keep
more detailed records does not conform
with current FAA-supervised
maintenance activities, and adds
unnecessary burdens and confusion
with respect to compliance with the
requirements.
EPA disagrees with amending these
paragraphs in the manner suggested in
the comments because the Agency
considers these requirements to be the
minimum necessary to ensure
accountability and facilitate regulatory
oversight to ensure compliance with the
rule. In addition, EPA believes that
detailed records of self-inspections are
necessary to inform the Agency about
the condition of the water system
components at the time of the
inspection and any deficiencies
identified during the inspection. A
record simply confirming performance
of a self-inspection would not be
sufficient. While EPA disagrees with
amending this paragraph in the manner
suggested in the comments, the Agency
believes that adding more specificity to
these recordkeeping requirements will
help to avoid confusion with respect to
compliance. Therefore, in today’s rule,
the Agency clarified this section by
adding that at a minimum, records of
disinfection and flushing must include
the following: Date and time of the
disinfection and flushing, and the type
of disinfection and flushing (i.e., routine
or corrective action). The recordkeeping
requirements for self-inspections were
also amended to align with existing
recordkeeping requirements for sanitary
surveys conducted by owners and
operators of stationary public water
systems. In the final rule, at a minimum,
records of self-inspection must include
the following: Completion date of the
self-inspection, and copies of any
written reports, summaries or
communications related to the selfinspection.
In the proposed rule, air carriers were
required to keep public notices to
passengers and crew for at least three
years after issuance. However, the
Agency received comments requesting
that EPA amend the proposed rule to
require air carriers to merely ‘‘keep a
record of notices to passengers and
crew’’ because the requirement to keep
physical notices would be operationally
difficult for air carriers. EPA disagrees
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with amending this paragraph in the
manner suggested in the comments
because the Agency believes a copy of
the physical notice is necessary to allow
the Agency to determine compliance
with the public notification
requirements of this rule. In addition,
EPA does not believe that this
requirement is burdensome or
operationally difficult because the
copies need not be in paper format. Air
carriers may keep electronic copies of
these notices in lieu of paper copies.
Thus, in the final rule, EPA clarifies that
the air carrier must keep copies of the
public notices given to passengers and
crew.
both sections. EPA agrees that the
reference to public notification
requirements in this section is confusing
and inconsistent with § 141.805.
Therefore, as noted previously, EPA
removed all references to public
notification from § 141.810 and made
conforming changes to § 141.805.
In addition, due to the removal of
fecal coliforms as a fecal indicator (as
discussed in section IV.C Responses to
Sample Results), all references to fecal
coliforms have been removed from the
violations to conform with the revision.
Other than the changes mentioned here,
the specific violations remain the same
in the final rule.
J. Audit and Self-Inspection
Requirements (§ 141.808)
L. Compliance Date
In place of the sanitary survey that is
required every five years for other
transient non-community public water
systems using surface water, the
proposed and final rules require that a
self-inspection be conducted by the air
carrier for each aircraft water system no
less frequently than once every five
calendar years. An inspection of the
entire aircraft water system need not be
completed in one day; the air carrier
need only ensure that all water system
components are inspected once every
five calendar years.
K. Violations (§ 141.810)
The Agency received several
comments on the proposed rule stating
that the notification requirements in
§ 141.810 conflict with the notification
requirements proposed in § 141.805,
and that to avoid confusion and
inconsistency, EPA should delete the
public notification requirements in this
section or make conforming changes to
In the proposed rule, air carriers
would be required to comply with the
rule within six months from the date of
publication for several reporting and
planning requirements, and 12 months
from the date of publication for the rest
of the rule requirements. While SDWA
section 1412(b)(10) generally requires a
three-year delay before new or amended
rules are effective, that provision also
authorizes EPA to set an earlier
compliance date if the Agency
determines that the earlier date is
practicable. At the time of the proposal
the Agency believed these dates were
practicable because EPA will implement
the rule, making it unnecessary to allow
time for States to obtain enforcement
authority prior to implementation of the
rule. In addition, most air carriers are
currently under AOCs which have
similar requirements to this rule. Thus,
EPA believed complying with the
ADWR should not require significant
changes in terms of operations and
maintenance procedures. However, the
53609
Agency received several comments
requesting that the compliance dates be
extended to be more consistent with the
three-year compliance date for new or
revised NPDWRs under SDWA (section
1412(b)(10)). Also, some commenters
expressed concern that the six-month
compliance date would be impracticable
because air carriers need more time to
restructure maintenance programs
between the AOCs and the final ADWR.
Commenters suggested compliance
dates of 18 months from the date of
publication for the reporting and
planning requirements, and 24 months
from the date of publication for the rest
of the rule.
The Agency agrees that the original
timeline for compliance in the proposed
rule may be too short for some air
carriers to meet, and more time may be
needed for air carriers to comply with
the requirements of the final rule.
Therefore, today’s rule requires air
carriers to comply with the
requirements of the rule within 18
months from the date of publication for
the reporting and planning requirements
and 24 months from the date of
publication for the rest of the rule
requirements (see Table IV–3). The 18month compliance date applies to the
following:
• Develop a coliform sampling plan
for existing aircraft and report to EPA
that the plans were developed;
• Report the coliform sampling
frequency included in the coliform
sampling plans;
• Develop an Aircraft Water System
Operations and Maintenance Plan for
existing aircraft and report to EPA that
the plans were developed;
• Report a complete inventory of
existing aircraft water systems.
TABLE IV–3—COMPLIANCE AND REPORTING DATES
Within the first
18 months following
publication of
the final rule
sroberts on DSKD5P82C1PROD with RULES
Requirement
Aircraft Water System Operations and Maintenance Plan:
Existing 1 Aircraft—develop the plan and report that it has been developed ......................................................................................................
New 2 Aircraft—develop the plan and report that it has been developed
Aircraft Coliform Sampling Plan:
Existing 1 Aircraft—develop the plan and report that it has been developed ......................................................................................................
New 2 Aircraft—develop the plan and report that it has been developed
Aircraft Frequency of Coliform Sampling and Routine Disinfection and
Flushing:
Existing 1Aircraft—report the routine frequency .......................................
New 2 Aircraft—report the routine frequency ............................................
Report any change 3 in routine frequency ................................................
Aircraft Inventory:
Existing Aircraft—report the inventory ......................................................
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Within the first
calendar
quarter of initial operation
Within 10 days
following the
calendar
month in
which the
change
occurred
Beginning 24
months after
publication of
the final rule
X
........................
........................
X
........................
........................
........................
........................
X
........................
........................
X
........................
........................
........................
........................
X
........................
........................
........................
X
........................
........................
........................
X
........................
........................
........................
X
........................
........................
........................
Sfmt 4700
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TABLE IV–3—COMPLIANCE AND REPORTING DATES—Continued
Within the first
18 months following
publication of
the final rule
Requirement
Report any change 3 to aircraft inventory .................................................
Aircraft Routine Requirements:
Conduct routine monitoring ......................................................................
Conduct routine disinfection and flushing ................................................
Within the first
calendar
quarter of initial operation
Within 10 days
following the
calendar
month in
which the
change
occurred
Beginning 24
months after
publication of
the final rule
........................
........................
X
........................
........................
........................
........................
........................
........................
........................
X
X
1 Existing Aircraft: means any aircraft that is in operation when the final rule is published or is brought into operation within the first 18 months
after the final rule is published.
2 New Aircraft: means any aircraft that is brought into operation after the 18th month following publication of the final rule.
3 Any changes made after the 18th month following publication of the final rule.
V. Cost Analysis
In estimating the costs of this rule,
EPA considered impacts on aircraft
water systems and air carriers, air
carrier passengers, as well as Agency
costs for rule implementation. Agency
costs are included in lieu of State costs
because implementation of the ADWR is
the responsibility of EPA as a regulation
applicable only to aircraft water
million at a 7 percent discount rate.
Table V–1 presents the itemized and
total annualized implementation costs
to air carriers (airlines) and EPA for the
ADWR at 3 and 7 percent discount rates.
Unit costs were multiplied by the
number of air carriers or aircraft
performing each requirement of the final
rule, and results were summed for all
components.
systems. EPA also considered certain
aspects of the ADWR that are nonquantified costs and that contribute to
uncertainties in the cost estimates.
A. National Cost Estimates
EPA estimates that the total
annualized implementation cost to the
air carriers of carrying out the activities
required in this ADWR is $7.04 million
at a 3 percent discount rate and $6.95
TABLE V–1—TOTAL ANNUALIZED PRESENT VALUE IMPLEMENTATION COSTS FOR THE FINAL ADWR
[$Millions, 2008$]
Air carriers
Agency
Total
Air carriers
3%
Agency
Total
7%
Implementation .........................................
Annual Administration ..............................
Sampling Plan ..........................................
O&M Plan .................................................
Coliform Monitoring ..................................
Routine Disinfection and Flushing ...........
Corrective Action Disinfection and Flushing .........................................................
Compliance Audit .....................................
$0.002
........................
0.002
0.01
4.89
2.08
$0.01
0.24
0.001
0.0001
0.04
........................
$0.01
0.24
0.002
0.01
4.93
2.08
$0.004
........................
0.002
0.02
4.82
2.05
$0.01
0.23
0.001
0.0001
0.04
........................
$0.02
0.23
0.003
0.02
4.86
2.05
0.05
0.01
........................
0.01
0.05
0.02
0.05
0.01
........................
0.01
0.05
0.02
Total ..................................................
7.04
0.30
7.34
6.95
0.30
7.25
As discussed more fully in the
preamble for the proposed rule (73 FR
19337), EPA notes that the cost of the
proposed ADWR was significantly less
than the current regulatory requirements
of the NPDWRs. The current NPDWR
requirements, considered to be the
baseline against which to compare the
set of regulatory requirements of the
ADWR, would continue to apply to the
aircraft water system industry if the
requirements of the ADWR were not
promulgated. The reduction in cost (i.e.,
the incremental savings of the ADWR
compared to the regulatory baseline) is
the result of tailoring the current
regulations for transient non-community
public water systems to the specific
operational characteristics of aircraft
drinking water systems.
EPA estimates that the total
annualized incremental savings of this
ADWR is $22.15 million at a 3 percent
discount rate and $21.83 million at a 7
percent discount rate, as presented in
Table V–2. The incremental savings
represent the difference in total
annualized implementation costs
between the baseline (i.e., the existing
NPDWRs) and the final rule provisions.
TABLE V–2—TOTAL ANNUALIZED INCREMENTAL COST: EXISTING NPDWRS AND THE ADWR
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[$Millions, 2008$]
Alt 1 (Existing
NPDWRs)
Alt 4 (Final
Rule)
Incremental
Cost (Alt
4¥Alt 1)
Alt 1 (Existing
NPDWRs)
3%
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Alt 4 (Final
Rule)
7%
Sfmt 4700
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Incremental
Cost (Alt
4¥Alt 1)
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TABLE V–2—TOTAL ANNUALIZED INCREMENTAL COST: EXISTING NPDWRS AND THE ADWR—Continued
[$Millions, 2008$]
Implementation .........................................
Annual Administration ..............................
Monitoring Plan ........................................
O&M Plan .................................................
Coliform Monitoring ..................................
Disinfectant Residual Monitoring .............
Routine Disinfection and Flushing ...........
Corrective Action Disinfection and Flushing .........................................................
Sanitary Survey/Compliance Audit ..........
Turbidity Monitoring .................................
0.01
0.24
0.002
........................
25.37
3.17
........................
0.01
0.24
0.002
0.01
4.93
........................
2.08
........................
0.7
........................
0.05
0.02
........................
Total ..................................................
29.49
The regulatory baseline does not
reflect the Administrative Orders on
Consent (AOCs), which are interim
enforcement actions applying to 45 air
carriers. As discussed earlier in this
notice, in 2004, EPA found all aircraft
that were public water systems to be out
of compliance with the NPDWRs. EPA
subsequently placed 45 air carriers
under AOCs that will remain in effect
until the 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. With respect to
sampling under the AOCs, air carriers
with greater than 20 aircraft were
required to sample 25 percent of their
fleet quarterly, while air carriers with 20
or fewer aircraft were required to
sample the entire fleet quarterly.
Because the majority of the air carriers
are currently subject to the requirements
of the AOCs, EPA notes that if the
requirements similar to the AOCs (i.e.,
Alternative 2 in the EA) were used as an
alternative baseline, the incremental
cost of the final ADWR would be $0.18
million at the 3 percent discount rate
and $0.18 million at the 7 percent
discount rate.
As described in section V.C, the final
rule provides additional cost savings to
air carriers over the proposed rule.
0
0
0
0.01
(20.44)
(3.17)
2.08
0.05
(0.68)
........................
7.34
0.02
0.23
0.004
........................
25.02
3.13
........................
0.02
0.23
0.003
0.02
4.86
........................
2.05
0
0
(0.001)
0.02
(20.16)
(3.13)
2.05
........................
0.69
........................
0.05
0.02
........................
0.05
(0.67)
........................
(22.15)
B. Estimated Impacts of the Final ADWR
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. For
purposes of this analysis, EPA estimates
that an average of 708.4 million
passengers travel each year on aircraft
that are affected by the ADWR. (See
Column E, Exhibit 5.3 of the Economic
and Supporting Analysis Document for
the Final ADWR, (USEPA, 2009)). The
cost passed on to passengers can be
roughly estimated by dividing the air
carriers’ annualized implementation
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. The Agency has chosen to use the
same number of passengers and flights
estimated for the proposed rule for the
final rule analysis in order to facilitate
cost comparisons between the proposed
and final rule provisions. This should
not significantly affect the cost per
passenger analysis.
C. Comparison of Costs From Proposed
Rule to Final Rule
As discussed in section III.A of this
notice, a collaborative rule development
process was used for the proposed
ADWR. This process provided an
opportunity for stakeholders to inform
the Agency about existing operations
and maintenance practices for aircraft
water systems and to convey concerns
29.08
7.25
(21.83)
regarding existing regulations applicable
to aircraft water systems, public health
issues, fleet operations issues that are
unique to the air carrier industry, and
potential rule alternatives. Public
comment was received on the proposed
rule, and modifications have been
incorporated into the final ADWR. Some
of the modifications to the proposed
rule that are incorporated into the final
rule affected the estimated cost of
implementing the regulation; other
changes had no net effect on cost as
modeled or are non-quantified costs.
This section provides a discussion of
the cost of the elements of the final
ADWR that changed in comparison to
the proposed rule and summarizes the
assumptions that have been
incorporated into the cost estimates.
The total annualized present value
implementation costs at 3 percent and 7
percent discount rates for the rule
provisions are shown in Table V–3 for
the proposed and final rules. The total
estimated annual quantified costs for
implementing the ADWR have changed
from the proposal costs of $8.13 million
and $8.24 million (year 2008 dollars,
using 3 and 7 percent discount rates,
respectively) to $7.34 million and $7.25
million (year 2008 dollars, using 3 and
7 percent discount rates, respectively).
The costs reported for the ADWR are
from Table V–1; the costs for the
proposed rule include adjustments for
the general cost assumptions and
methodology applied to the ADWR (e.g.,
labor rates), with all costs adjusted to
2008 dollars.
TABLE V–3—COMPARISON OF PROPOSED AND FINAL ADWR TOTAL ANNUALIZED PRESENT VALUE IMPLEMENTATION
COSTS
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[$Millions, 2008$]
3%
Proposal
Implementation ........................................................................................................
Annual Administration ..............................................................................................
Monitoring Plan ........................................................................................................
O&M Plan ................................................................................................................
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3%
Final
0.01
0.25
0.002
0.01
E:\FR\FM\19OCR2.SGM
0.01
0.24
0.002
0.01
19OCR2
7%
Proposal
0.01
0.25
0.004
0.02
7%
Final
0.02
0.23
0.003
0.02
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TABLE V–3—COMPARISON OF PROPOSED AND FINAL ADWR TOTAL ANNUALIZED PRESENT VALUE IMPLEMENTATION
COSTS—Continued
[$Millions, 2008$]
3%
Proposal
3%
Final
7%
Proposal
7%
Final
Coliform Monitoring ..................................................................................................
Routine Disinfection and Flushing ...........................................................................
Corrective Action Disinfection and Flushing ............................................................
Compliance Audit .....................................................................................................
5.50
2.21
0.13
0.02
4.93
2.08
0.05
0.02
5.57
2.23
0.13
0.02
4.86
2.05
0.05
0.02
Total ..................................................................................................................
* 8.13
7.34
* 8.24
7.25
sroberts on DSKD5P82C1PROD with RULES
* For the proposal, the total annualized present value cost at a 3% discount rate is less than at a 7% discount rate by a small amount.
Changes in the implementation schedule (later implementation) for the final rule result in a larger calculated difference in present value costs,
which results in total annualized present value costs slightly greater at a 3% discount rate than at a 7% rate.
The change in quantified costs
between the proposed and final ADWR
primarily is due to the additional
flexibility in the ADWR provided to air
carriers in choosing one of four options
for flushing and disinfection frequency.
Additional cost savings are due to
changes in EPA’s estimate of the cost to
air carriers for implementation based on
the percentage of aircraft that will select
each option, the percentage of routine
and repeat total coliform monitoring
samples that are anticipated to be total
coliform-positive, and the options
available to air carriers for addressing
total coliform-positive test results.
These assumptions and regulatory
impacts are discussed below and in
more detail in the final ADWR
Economic Analysis.
The final rule includes an extension
of the compliance dates to 18 months
after rule publication for the coliform
sampling plan, operations and
maintenance plan, and the aircraft
inventory; the proposed rule specified a
6-month timeframe for these
requirements. In addition, the final rule
adjusts the timeframe for beginning to
conduct sampling and other compliance
requirements to 24 months after final
rule publication from 12 months
specified in the proposed rule. These
delays in compliance dates have a slight
effect on the timing of the costs
represented by the 25-year compliance
period captured by these estimates.
There is a one-time cost for reading
and understanding the rule, becoming
familiar with its provisions, and training
employees on the rule. The final ADWR
provides a burden allowance for each
air carrier to read and understand the
rule of eight hours per carrier, increased
from two hours per carrier in the
proposed rule. This change was made in
response to public comments received
on the proposed rule which conveyed
that air carriers would typically have
more than one individual responsible
for this aspect of rule implementation.
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Commenters expressed concern that the
proposed rule burden estimate of a
single individual spending two hours to
read and understand the rule did not
adequately capture the true air carrier
needs. In response to those concerns,
the Agency assumes, on average, each
air carrier will have four staff persons
who will need to read and understand
the rule at two hours estimated burden
for each person. The eight hours per air
carrier for staff training is unchanged
from the proposed rule.
The coliform monitoring category
includes cost estimates for routine
sampling and repeat sampling; followup coliform monitoring is captured
under corrective action disinfection and
flushing cost estimates. Each aircraft
routine coliform monitoring schedule is
determined by the routine disinfection
and flushing frequency that should be
based on manufacturer’s
recommendations. EPA is providing air
carriers with additional flexibility in the
final rule by allowing air carriers to
select any of the disinfection and
flushing options in the absence of a
manufacturer’s recommendation.
Although the specific routine
monitoring frequency to be used by each
aircraft is unknown, the Agency made
assumptions on the frequencies they
would follow and incorporated those
assumptions into the cost model.
Because selection of an option best
suited to other operations and
maintenance obligations of the aircraft
is anticipated to help minimize flight
disruption events but its effect is
unknown, it is included in the
uncertainties of the cost model.
The assumptions of the percentage of
aircraft that would select each of the
monitoring frequency options have been
adjusted to incorporate the fourth
option that is included in the final rule.
As discussed previously, the addition of
the fourth option for routine
disinfection and flushing frequency was
in response to public comment, which
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would also result in fewer flight
disruptions necessary for aircraft water
system maintenance needs. For the final
rule, the Agency assumed 10 percent of
the aircraft would follow monthly
monitoring with routine disinfection
and flushing one time per year or less;
30 percent would follow monitoring
quarterly with routine disinfection and
flushing twice per year; 30 percent
would follow monitoring twice per year
with routine disinfection and flushing 3
times per year; and 30 percent would
follow annual monitoring with routine
disinfection and flushing on a quarterly
basis. The proposed rule assumed 10
percent of the aircraft would monitor
monthly, 45 percent quarterly, and 45
percent annually.
Several other provisions in the final
rule and their related assumptions affect
the estimated cost for coliform
monitoring. Those provisions include a
reduction of the number of repeat
samples to three in the final rule from
four in the proposed rule, and allowing
repeat sampling if more than one
routine sample is total coliform-positive
but E. coli-negative. The proposed rule
limited the option for repeat sampling to
situations when no more than one
routine sample was total coliformpositive.
The final ADWR utilized the coliform
monitoring findings of the air carrier
AOCs processed as of December 31,
2008, for estimates of the percentage of
routine and repeat samples that are
anticipated to be total coliform-positive
and E. coli-positive. A discussion of the
AOCs data is found in section III.B of
this notice. For the final rule, a routine
sample total coliform-positive rate of 3.6
percent and a repeat sample total
coliform-positive rate of 5.7 percent are
assumed based on the AOCs results. The
proposed rule applied a routine sample
rate of 3.1 percent based on data
available at the time, and a repeat
sample rate of 50 percent.
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Assumptions pertaining to the
number of corrective action disinfection
and flushing events that would be
incurred were recalculated based on
whether the aircraft was anticipated to
already be scheduled for routine
disinfection and flushing in the
immediate future. In addition, if the
water system is physically shut-off to
prevent public access to the water
system within 24 hours of notification
of the need to restrict public access, the
final rule removed the requirement that
an aircraft with total coliform-positive
or E. coli-positive water samples must
be disinfected and flushed within a
prescribed time period.
The Agency assumed, based on
comments received on the proposed
rule, that air carriers would seek to
minimize the number of times
unscheduled disinfection and flushing
events that would occur and would take
advantage of the ability to perform
corrective action as part of the routine
disinfection and flushing activities.
Carriers can do this by scheduling
routine sampling just prior to routine
disinfection and flushing. Then, if a
total coliform- or E. coli-positive sample
is found, carriers can address the
situation immediately through
disinfection and flushing that would
have occurred anyway, thereby merely
adding the step of follow-up sampling to
confirm that the flushing and
disinfection has resolved the problem.
Further, EPA believes that if public
access to the water system is physically
prevented because the water system is
shut-off, more time is warranted to
allow scheduling of the corrective
action disinfection and flushing
procedure to minimize flight
disruptions.
Finally, the estimated reduction in the
repeat sample total coliform-positive
rate to 5.7 percent in the final rule from
50 percent in the proposed rule affected
the anticipated costs for this category
because fewer events were expected to
be triggered by repeat sample results.
D. Non-Quantified Costs and
Uncertainties
1. Non-Quantified Costs
Although EPA has estimated the
majority of implementation costs of this
ADWR, there are some costs that EPA
was not able to quantify, such as:
• Air carrier costs due to
unanticipated flight interruptions from
aircraft water system corrective action
maintenance needs. This includes the
direct costs related to transporting an
aircraft to a maintenance facility for the
performance of disinfection and
flushing corrective action events and
any indirect costs of schedule
disruptions or delays if an aircraft must
be unexpectedly taken out of service.
• Passenger costs due to flight
cancellations or delays related to
unanticipated aircraft water system
maintenance triggered solely by water
quality issues.
• Air carrier costs to provide bottled
water due to lack of onboard tap water
during a restrict public access event.
53613
• Air carrier customer service
response to customer concerns
following public notification that the
water onboard an aircraft is not to be
used for human consumption.
EPA has attempted to minimize costs
by building flexibility into the ADWR,
including various alternatives from
which air carriers select compliance
scenarios that best meet their flight
schedules and other routine aircraft
operations and maintenance needs. The
final rule also includes provisions that
minimize situations in which an aircraft
is taken out of service solely due to
drinking water system water quality
issues, though this is sometimes
necessary to protect consumers from
water of unacceptable quality when the
system cannot be physically shut-off or
the flow of water through the tap(s)
cannot be prevented.
Table V–4 presents the number of
monitoring and disinfection and
flushing events per year estimated for
the proposed and final rules. EPA
assumes routine coliform monitoring
and routine disinfection and flushing of
the water system would not disrupt
service because the air carrier will
incorporate these tasks into the aircraft
operations and maintenance program.
Only the unanticipated corrective action
disinfection and flushing events shown
in Column C of the table reflect the
events that the Agency estimates could
result in unscheduled disruptions to air
carriers’ schedules for the proposed or
final rules.
TABLE V–4—ESTIMATED MONITORING AND DISINFECTION AND FLUSHING EVENTS FOR THE PROPOSED AND FINAL ADWR
Routine
coliform
monitoring
events/year
Routine
disinfection
and flushing
events/year
Corrective
action
disinfection
and flushing
events/year
Total number
of disinfection
and flushing
events/year
A
B
C
D=B+C
Proposed Rule .................................................................................................
Final Rule .........................................................................................................
26,593
25,436
20,516
20,516
1,175
395
21,691
20,911
sroberts on DSKD5P82C1PROD with RULES
(C) The number of potential unanticipated corrective action disinfection and flushing events is shown for the proposed and final rules. All other
disinfection and flushing events, whether based on a routine schedule or in response to monitoring results, would occur during scheduled water
system operations and maintenance.
The significant decrease in the
number of corrective action disinfection
and flushing events in the final ADWR
shown in Column C reflects the
anticipated practice that air carriers will
maximize the scheduling of routine
coliform sampling with routine
disinfection and flushing. This would
likely result in a decrease in
unscheduled flight disruptions because
total coliform-positive samples may be
immediately addressed through water
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system disinfection and flushing while
the aircraft is already out of service. The
final rule allows such disinfection and
flushing to count toward both the
corrective action and the routine
procedures if follow-up total coliform
samples required for corrective action
are collected. Of the corrective action
disinfection and flushing events noted
in Column C, an unknown percentage
will not disrupt service because the air
carrier will either prevent public access
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to the water by shutting-off the system,
thereby obtaining more flexibility with
respect to scheduling and performing
the corrective action disinfection and
flushing, or will be able to perform the
action within the maximum time frame
specified by the rule without disrupting
service.
2. Uncertainties in Cost Estimates
Many factors contribute to uncertainty
in the national cost estimates including:
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Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 / Rules and Regulations
• Percent of aircraft that will be
subject to each total 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 to develop a training
program, train staff, and oversee
compliance.
• Percent of aircraft that will collect
routine total coliform samples while
aircraft are out of service for routine
maintenance.
• Labor burden necessary for selfinspections above what is necessary for
FAA-related inspections.
• Labor burden and costs associated
with correcting significant deficiencies
that are identified during selfinspections above what is necessary for
FAA-related inspections.
For simplicity, EPA assumed for this
analysis that all air carriers subject to
the final rule will 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 rule
management and oversight requirements
could result in an over- or underestimate of the costs presented.
Regarding the expected results for
coliform monitoring, EPA assumed that
during routine coliform monitoring,
each total coliform-positive sample
would prompt an action by the air
carrier. This assumption potentially
over-estimates the number of aircraft
that need to undergo disinfection and
flushing as corrective action or repeat
monitoring in cases where more than
one routine sample is total coliformpositive in a given monitoring period.
For example, an aircraft with positive
samples from both routine sampling
points is treated as two corrective
actions or repeat sample collection
events in the cost model when only one
disinfection and flushing event would
be necessary in such a case. Also, the
number of sample results that prompt
corrective action or repeat sampling
may decrease over time as air carriers
correct problems that lead to total
coliform-positive samples.
In developing costs for air carriers to
comply with the 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 selfinspections, which involve a thorough
review and inspection of an aircraft
water system as well as addressing any
deficiencies, is already captured under
current FAA requirements and therefore
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is not included in the cost estimate for
this rule. Additionally, EPA has
assumed that deficiencies noted during
self-inspections will be addressed
during routine maintenance, and so has
not accounted for costs associated with
corrective actions stemming from
deficiencies noted during selfinspections. This assumption
potentially under-estimates air carrier
burden for self-inspections.
VI. Benefits Analysis
For the proposed rule, EPA conducted
and presented a qualitative analysis
comparing the risks for each regulatory
alternative considered during the
regulatory process (73 FR 19338). EPA
did not conduct a risk assessment, and
the qualitative analyses were not
intended to provide any insights into
either the nature or the 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.
As of the time of publication of the
final rule, only limited baseline data
and partial data collected under the
AOCs are available for analysis.
Additionally, EPA has found no data on
outbreaks of illness caused by drinking
water on aircraft. Therefore, EPA has
determined that it is not feasible to
perform a quantitative relative risk
analysis at this time. EPA will continue
to assess aircraft water system
monitoring data during the Agency’s
Six-Year review of NPDWRs and
evaluate whether additional quantitative
analyses represent an opportunity for
revisions to the ADWR. (Section 1412
(b)(9) of the Safe Drinking Water Act
requires that EPA, no less than every six
years, review and if appropriate, revise
existing drinking water standards.)
This rule has been developed 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 indicator organisms.
Total coliforms are a group of closely
related, generally harmless bacteria that
live in soil and water, as well as in the
digestive tracts of animals, and are
therefore present in feces. The presence
of total coliforms in drinking water
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suggests there has been a breach, failure,
or other change in the integrity of the
drinking water and that there may be
fecal pathogens present in the water.
Because some total coliform bacteria are
naturally found in the environment,
their presence in a drinking water
distribution system may not indicate the
presence of fecal contamination. In
order to obtain more information on the
likelihood of fecal contamination the
total coliform-positive sample is
analyzed for E. coli, a member of the
total coliform group that is more likely
to originate from warm-blooded animal
fecal contamination.
Although EPA does not have data on
outbreaks, 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
underreporting 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. Waterborne pathogens are
particularly harmful to sensitive
populations, such as the immunocompromised, and can sometimes prove
fatal.
Routine disinfection and flushing
required by this rule is expected to
inactivate pathogens and control biofilm
which can harbor pathogens in the
aircraft water storage tank and
distribution system that can contribute
to endemic disease. Likewise,
disinfection and flushing associated
with corrective action is also expected
to inactivate 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 ADWR will
reduce the occurrence of illness passed
through secondary spread (the spread of
a pathogen within a field after the initial
or primary infection). Furthermore, EPA
expects the additional barriers to
pathogens required under the ADWR,
including disinfection and flushing
combined with monitoring, water
system training requirements for air
carrier personnel, and restricting public
access to drinking water when
necessary, will reduce the likelihood of
outbreaks associated with aircraft
drinking water.
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VII. Statutory and Executive Order
Reviews
sroberts on DSKD5P82C1PROD with RULES
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.’’ 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 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
requirements are not enforceable until
OMB approves them. The Information
Collection Request (ICR) document
prepared by EPA has been assigned EPA
ICR number 2279.02.
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 final rule to support the
responsibilities directed by SDWA and
the implementation of the ADWR in the
areas of monitoring and disinfecting and
flushing, 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 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
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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 six 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 ADWR is
based, is being revised in accordance
with the finding of EPA’s first Six-Year
Review (68 FR 42907, July 18, 2003).
Publication of this final rule complies
with these statutory requirements.
Burden Estimate
The universe of respondents for the
Information Collection Request (ICR) for
this final rule comprises 63 air carriers
that operate approximately 7,327
aircraft water systems, classified as
Transient Non-Community Water
Systems. The total burden associated
with ADWR requirements over the 3
years covered by the ICR is 62,291
hours, an average of 20,764 hours per
year. The total cost over the 3-year
period is $7.54 million, an average of
$2.5 million per year (simple average
over 3 years). For air carriers, the total
burden for the 3-year ICR period is
52,750 hours. The burden per response
is .3 hours. During this period air
carriers will undertake 179,773
responses. The respondent costs for the
same period are $7.06 million. The labor
cost is $1.90 million. The O&M cost (for
sample analysis and shipping) is $5.16
million. The capital cost is $4,179. The
air carrier average annual respondent
burden is 17,583 hours, and the average
cost per year is $2.35 million. The cost
per response is $39. Burden is defined
at 5 CFR 1320.3(b).
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
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53615
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.
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 as: (1) A small
business as defined by the Small
Business Administration’s (SBA)
regulations at 13 CFR 121.201; (2) a
small governmental jurisdiction that is a
government of a city, county, town,
school district or special district with a
population of less than 50,000; and (3)
a small organization that is any ‘‘not-forprofit enterprise which is independently
owned and operated and is not
dominant in its field.’’ However, the
RFA also authorizes an agency to use
alternative definitions for each category
of small entity, ‘‘which are appropriate
to the activities of the agency’’ after
proposing the alternative definition(s) in
the Federal Register and taking
comment. 5 U.S.C. 601(3)–(5). In
addition, to establish an alternative
small business definition, agencies must
consult with SBA’s Chief Counsel for
Advocacy.
For purposes of assessing the
economic impacts of this final rule on
small entities, EPA proposed defining
‘‘small entity’’ using the SBA 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’’). See 73 FR
19320, April 9, 2008.
The Agency has consulted with the
SBA Chief Counsel for Advocacy on
using the SBA small business definition
of fewer than 1,500 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
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entity definition for air carriers for the
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
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.
The Agency did not receive any
comments on the use of this alternative
definition of small entity in EPA’s
proposed rule of April 9, 2008 (73 FR
19320).
Today, EPA is establishing this
alternative definition of ‘‘small entity’’
for purposes of its regulatory flexibility
assessments under the RFA for this rule,
any revisions to this rule, and any future
drinking water regulations that address
air carriers.
After considering the economic
impacts of this final 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). EPA has estimated that 30 of
the 63 air carriers subject to this final
rule are small businesses. These 30 air
carriers represent 48 percent of the
universe of air carriers subject to the
final rule, and all will be subject to the
various provisions.
In evaluating whether this rule will
have a significant impact on these small
entities, EPA first determined the
present value costs of the rule for these
air carriers. EPA followed the same
methodology as was used to develop the
average annualized costs for the rule
overall. EPA estimates a total annual
implementation cost for all small air
carriers of $524,380 at a 3 percent
discount rate and $521,110 at a 7
percent discount rate. EPA also
determined the average annual rule cost
per small air carrier of $17,543
(annualized at 3 percent).
EPA estimates the average annual
incremental rule cost for small entities
(the difference between the final rule
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and the existing NPDWRs (presented as
Alternative 1)) is a reduction of
$258,599 at a 3 percent discount rate for
compliance with the ADWR. Because
the majority of the air carriers are
currently subject to the requirements of
the AOCs, EPA notes that if the AOCs
were considered to be an alternative
baseline, the incremental average
annual rule cost between the final rule
and requirements similar to those of the
AOCs, (presented as Alternative 2) is a
reduction of $32,188 (i.e., cost savings).
Recognizing the variation of company
sizes within this group, EPA has
estimated the average annual
incremental cost for small air carriers
with fewer than 500 employees and for
small air carriers with 500 or more
employees. For the 17 air carriers with
fewer than 500 employees, the annual
incremental cost between the ADWR
and Alternative 1 for each air carrier is
a reduction of $78,042 at a 3 percent
discount rate, and the annual
incremental average rule cost between
the ADWR and Alternative 2 is a
reduction of $7,781 at a 3 percent
discount rate. For the 13 small air
carriers with 500 or more employees,
the incremental cost between the ADWR
and Alternative 1 for each air carrier is
a reduction of $230,712 at a 3 percent
discount rate, and the incremental
average rule cost between the ADWR
and Alternative 2 is a reduction of
$20,104 at a 3 percent discount rate.
The final rule has been shown to offer
a cost reduction over the existing
regulations (i.e., baseline), and so the
annualized incremental costs are
negative. Therefore, EPA has not
compared the average annual
incremental costs to small entities
against the average annual revenue of
the small entities as is normally done
for this analysis.
Based on this analysis, EPA certifies
that the final ADWR will not have a
significant impact on a substantial
number of small entities; therefore, the
Agency did not develop an Initial
Regulatory Flexibility Analysis for the
rule.
D. Unfunded Mandates Reform Act
This rule 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. States, local, and Tribal
governments will not incur annual costs
associated with this final 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
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subject to the requirements of sections
202 or 205 of UMRA.
For these reasons, this rule is also not
subject to the requirement of section 203
of UMRA because it 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 final 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 solicited comment on the
proposed rule from State and local
officials, and the comments can be
found in the docket for this rule and is
addressed in the Response to Comment
document (816–R0–9008) .
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000). The provisions of this final rule
apply to all aircraft transient noncommunity 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 action.
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G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
This action is not subject to EO 13045
(62 FR 19885, April 23, 1997) because
it is not economically significant as
defined in EO 12866.
While this final 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 final 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 final 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 action is not a ‘‘significant
energy action’’ as defined in Executive
Order 13211 (66 FR 18355 (May 22,
2001)), because it is not likely to have
a significant adverse effect on the
supply, distribution, or use of energy.
Additionally, none of the final rule
requirements involve installation of
treatment or other components that use
a measurable amount of energy.
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I. National Technology Transfer and
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (‘‘NTTAA’’), Public Law
104–113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus standards
bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations
when the Agency decides not to use
available and applicable voluntary
consensus standards.
This final rule involves voluntary
consensus standards in that it would
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require monitoring for total coliform
and E. coli, and monitoring and sample
analysis methodologies are often based
on voluntary consensus standards.
However, the final 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.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order (EO) 12898 (59 FR
7629, February 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 final
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.
This final 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 any minority or
low-income population who are aircraft
passengers.
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
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53617
Act (SDWA), the Agency consulted with
the National Drinking Water Advisory
Council (NDWAC or the Council); the
Secretary of Health and Human
Services; and the Science Advisory
Board (SAB), Drinking Water
Committee.
EPA met with the SAB’s Committee
on July 24, 2008, and received
comments from the Committee on
October 1, 2008. The Committee’s
comments were valuable and taken into
consideration in shaping the future
direction of the final ADWR with
regards to statistical sampling and hot
water tap sampling. As previously
mentioned, the majority of the
Committee members of EPA’s Science
Advisory Board were not in favor of
statistical sampling of aircraft drinking
water quality at this time because the
available data is too sparse to interpret
results for the whole fleet. The
Committee members did indicate that
future data collected during
implementation of ADWR may provide
information on how to stratify samples.
In addition, some members of the
Committee indicated a preference to
sampling cold water taps only; EPA
agrees with some Committee members
that there may be a potential for the
temperature in the hot water taps to kill
existing microorganisms, and this might
mask whether there is a microbiological
problem in the aircraft system. Thus,
samples should be taken from cold
water taps when they are available,
except in the case when only hot water
taps are available in the galley. In this
case, the galley sample should be taken
from the hot water tap because that
water is being served to passengers and
crew, EPA plans to further discuss tap
sampling in its ADWR technical
guidance.
The Agency consulted with NDWAC
during the Council’s May 25–27, 2007,
meeting, and consulted with the
Council on May 28, 2009. In general, in
the May 2007 meeting, NDWAC
recommended that EPA consider and
request public comment on best
management practices (BMPs) and
public notification requirements, which
may be feasible alternatives for the air
carrier industry while providing greater
public health protection. EPA has
incorporated these recommendations
into the ADWR by providing flexible
BMP alternatives and timely notification
requirements which have been tailored
specifically to meet the unique
operational characteristics of aircraft
public systems and the air carrier
industry. During the May 2009 NDWAC
meeting, EPA presented the key issues
raised by commenters on the proposal
and areas of decision faced by the
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Agency. No substantive comments were
provided by NDWAC.
On August 8, 2007, EPA consulted
with the Department of Health and
Human Services (HHS) on the proposed
rule. EPA also consulted with HHS on
the final rule and received a favorable
response to the Agency’s novel
approach and development of the
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. Whenever possible, EPA
wrote the action in active voice, with
simplified language, and displayed
information in tables to make it easier
for the public to read and understand.
sroberts on DSKD5P82C1PROD with RULES
M. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A Major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2). This rule
will be effective November 18, 2009.
N. Analysis of the Likely Effect of
Compliance With the ADWR on the
Technical, Financial, and Managerial
Capacity of Public Water Systems
Section 1420(d)(3) of SDWA, as
amended, requires that, in promulgating
a NPDWR, the Administrator shall
include an analysis of the likely effect
of compliance with the regulation on
the technical, managerial, and financial
(TMF) capacity of regulated entities.
This analysis can be found in the
Economic and Supporting Analyses
document in EPA’s public docket.
Analyses reflect only the impact of new
or revised requirements, as established
by the ADWR; the impacts of previously
established requirements are not
considered.
VIII. References
ATA (Air Transport Association of America,
Inc.) 2003. Air Transport Association:
Aircraft Drinking Water Sampling Program,
Final Report: December 31, 2003. https://
www.airlines.org.
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17:06 Oct 16, 2009
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Canada. 2007a. Health Canada. Healthy
Living. Aircraft Inspection Program—
Frequently Asked Questions. https://
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.
https://www.hc-sc.gc.ca/ahc-asc/media/
advisories-avis/2006/2006_53_e.html.
Davison, A., Howard, G., Stevens, M., et al.
2005. Water, Sanitation and Health
Protection and the Human Environment,
World Health Organization, Geneva. Water
Safety Plans: Managing drinking-water
quality from catchment to consumer.
https://www.who.int/water_
sanitation_health/.
Lehtola, M., Torvinen, E., Kusnetsov, J., et al.
2007. Survival of Mycrobacterium avium,
Legionella pneumophila, Escherichia coli,
and Caliciviruses in Drinking WaterAssociated Biofilms Grown under HighShear Turbulent Flow. Applied and
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; Aircraft Drinking Water Rule.
EPA 816–D–08–002.
USEPA. 2008. DRAFT Information Collection
Request for the National Primary Drinking
Water Regulations: Aircraft Drinking Water
Rule. EPA 816–D–08–001.
USFDA. 2005. Title 21—Food and Drugs,
Chapter 1—Food and Drug Administration,
Part 1250—Interstate Conveyance
Sanitation. https://www.accessdata.fda.
gov/.
WHO. 1997. HACCP—Introducing the
Hazard Analysis and Critical Control Point
System. Geneva, Switzerland: WHO.
WHO. 2004. Guidelines for Drinking-Water
Quality. 3rd Edition, Volume 1—
Recommendations, Chapter 4 Water
Supply Plans. Geneva, Switzerland: WHO.
List of Subjects in 40 CFR Part 141
Environmental protection, Chemicals,
Indian-lands, Intergovernmental
relations, Radiation protection,
Reporting and recordkeeping
requirements, Water supply.
Dated: October 5, 2009.
Lisa P. Jackson,
Administrator.
For the reasons set out in the
preamble, title 40, chapter 1 of the Code
of Federal Regulations is to be amended
as follows:
■
PART 141—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
1. The authority citation for part 141
continues to read as follows:
■
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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 to 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
§ 141.800
date.
Applicability and compliance
(a) Applicability. The requirements of
this subpart constitute the National
Primary Drinking Water Regulations for
aircraft that are public water systems
and that board only finished water for
human consumption. Aircraft public
water systems are considered transient
non-community water systems
(TNCWS). 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.
(b) Compliance Date. Aircraft public
water systems must comply, unless
otherwise noted, with the requirements
of this subpart beginning October 19,
2011. Until this compliance date, air
carriers remain subject to existing
national primary drinking water
regulations.
§ 141.801
Definitions.
As used in this subpart, the term:
Administrator means the
Administrator of the United States
Environmental Protection Agency or
his/her 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
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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 for human
consumption to passengers or crew.
Aircraft Water System Operations 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 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
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 the water
supply, methods, and facilities used for
the delivery of finished water to the
aircraft. These facilities may include
water trucks, carts, cabinets, and hoses.
§ 141.802
Coliform sampling plan.
(a) Each air carrier under this subpart
must develop a coliform sampling plan
covering each aircraft water system
owned or operated by the air carrier that
identifies the following:
(1) Coliform sample collection
procedures that are consistent with the
requirements of § 141.803(a) and (b).
(2) Sample tap location(s)
representative of the aircraft water
system as specified in § 141.803(b)(2)
and (b)(4).
(3) Frequency and number of routine
coliform samples to be collected as
specified in § 141.803(b)(3).
(4) Frequency of routine disinfection
and flushing as specified in the
operations and maintenance plan under
§ 141.804.
(5) Procedures for communicating
sample results promptly so that any
required actions, including repeat and
follow-up sampling, corrective action,
and notification of passengers and crew,
will be conducted in a timely manner.
(b) Each air carrier must develop a
coliform sampling plan for each aircraft
with a water system meeting the
definition of a public water system by
April 19, 2011.
(c) The coliform sampling plan must
be included in the Aircraft Water
System Operations and Maintenance
Plan required in § 141.804. Any
subsequent changes to the coliform
sampling plan must also be included in
the Aircraft Water System Operations
and Maintenance Plan required in
§ 141.804.
§ 141.803
Coliform sampling.
(a) Analytical Methodology. Air
carriers must follow the sampling and
analysis requirements under this
section.
(1) The standard sample volume
required for total coliform analysis,
regardless of analytical method used, is
100 mL.
(2) Air carriers need determine only
the presence or absence of total
coliforms and/or E. coli; a determination
of density of these organisms is not
required.
(3) Air carriers must conduct analyses
for total coliform and E. coli in
accordance with the analytical methods
approved in § 141.21(f)(3) and
141.21(f)(6).
(4) The time from sample collection to
initiation of analysis may not exceed 30
hours. Systems are encouraged but not
required to hold samples below 10°C
during transit.
(5) The invalidation of a total coliform
sample result can be made only by the
Administrator in accordance with
53619
§ 141.21(c)(1)(i), (ii), or (iii) or by the
certified laboratory in accordance with
§ 141.21(c)(2).
(6) Certified laboratories. For the
purpose of determining compliance
with this subpart, samples may be
considered only if they have been
analyzed by a laboratory certified by a
State or EPA. For the purposes of this
paragraph, ‘‘State’’ refers to a State or
Tribe that has received primacy for
public water systems (other than aircraft
water systems) under section 1413 of
SDWA.
(b) Routine Monitoring. For each
aircraft water system, the sampling
frequency must be determined by the
disinfection and flushing frequency
recommended by the aircraft water
system manufacturer, when available,
and as identified in the operations and
maintenance plan in § 141.804.
(1) Except as provided in paragraph
(b)(2) of this section, the air carrier must
collect two 100 mL total coliform
routine samples at the frequency
specified in the sampling plan in
§ 141.802 and in accordance with
paragraph (b)(3) of this section;
(2) The air carrier may collect one 100
mL total coliform routine sample at the
frequency specified in the sampling
plan in § 141.802 for aircraft with a
removable or portable tank that is
drained every day of passenger service,
and the aircraft has only one tap.
Aircraft meeting the requirements of
this paragraph do not have to comply
with paragraph (b)(4) of this section.
(3) Air carriers must perform routine
monitoring for total coliform at a
frequency corresponding to the
frequency of routine disinfection and
flushing as specified in the Table b–1
(Routine Disinfection and Flushing and
Routine Sample Frequencies). Air
carriers must follow the disinfection
and flushing frequency recommended
by the aircraft water system
manufacturer, when available. Where
the aircraft water system manufacturer
does not specify a recommended routine
disinfection and flushing frequency, the
air carrier must choose a frequency from
Table b–1 (Routine Disinfection and
Flushing and Routine Sample
Frequencies):
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TABLE B–1—ROUTINE DISINFECTION AND FLUSHING AND ROUTINE SAMPLE FREQUENCIES
Minimum routine disinfection & flushing per
aircraft
Minimum frequency of routine samples per
aircraft
At least 4 times per year = At least once within every three-month period (quarterly).
At least 3 times per year = At least once within every four-month period.
At least 1 time per year = At least once within every twelve-month period (annually).
At least 2 times per year = At least once within every six-month period
(semi-annually).
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TABLE B–1—ROUTINE DISINFECTION AND FLUSHING AND ROUTINE SAMPLE FREQUENCIES—Continued
Minimum frequency of routine samples per
aircraft
At least 2 times per year = At least once within every six-month period
(semi-annually).
At least 1 time per year or less = At least once within every twelvemonth period (annually) or less.
sroberts on DSKD5P82C1PROD with RULES
Minimum routine disinfection & flushing per
aircraft
At least 4 times per year = At least once within every three-month period (quarterly).
At least 12 times per year = At least once every month (monthly).
(4) One sample must be taken from a
lavatory and one from a galley; each
sample must be analyzed for total
coliform. 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.
(5) If any routine, repeat, or follow-up
coliform sample is total coliformpositive, the air carrier must analyze
that total coliform-positive culture
medium to determine if E. coli is
present.
(6) Routine total coliform samples
must not be collected within 72 hours
after completing routine disinfection
and flushing procedures.
(c) Routine Coliform Sample Results.
(1) Negative Routine Coliform Sample
Results. If all routine sample results are
total coliform-negative, then the air
carrier must maintain the routine
monitoring frequency for total coliform
as specified in the sampling plan in
§ 141.802.
(2) Positive Routine E. coli Sample
Results. If any routine sample is E. colipositive, the air carrier must perform all
of the following:
(i) Restrict Public Access. Restrict
public access to the aircraft water
system in accordance with paragraph (d)
of this section as expeditiously as
possible, but in no case later than 24
hours after the laboratory notifies the air
carrier of the E. coli-positive result or
discovery of the applicable failure as
specified in paragraphs (g) and (h) of
this section. All public access
restrictions, including applicable public
notification requirements, must remain
in-place until the aircraft water system
has been disinfected and flushed and a
complete set of follow-up samples is
total coliform-negative; and
(ii) Disinfect and Flush. Conduct
disinfection and flushing in accordance
with § 141.804(b)(2). If the aircraft water
system cannot be physically
disconnected or shut-off, or the flow of
water otherwise prevented through the
tap(s), then the air carrier must disinfect
and flush the system no later than 72
hours after the laboratory notifies the air
carrier of the E. coli-positive result or
discovery of the applicable failure as
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specified in paragraphs (g) and (h) of
this section; and
(iii) Follow-up Sampling. Collect
follow-up samples in accordance with
paragraph (e) of this section. A complete
set of follow-up sample results must be
total coliform-negative before the air
carrier provides water for human
consumption from the aircraft water
system and returns to the routine
monitoring frequency as specified in the
sampling plan required by § 141.802.
(3) Positive Routine Total Coliform
Sample Results. If any routine sample is
total coliform-positive and E. colinegative, then the air carrier must
perform at least one of the following
three corrective actions and continue
through with that action until a
complete set of follow-up or repeat
samples is total coliform-negative:
(i) Disinfect and Flush. In accordance
with § 141.804(b)(2), conduct
disinfection and flushing of the system
no later than 72 hours after the
laboratory notifies the air carrier of the
total coliform-positive and E. colinegative result. After disinfection and
flushing is completed, the air carrier
must collect follow-up samples in
accordance with paragraph (e) of this
section prior to providing water for
human consumption from the aircraft
water system. A complete set of followup sample results must be total
coliform-negative before the air carrier
returns to the routine monitoring
frequency as specified in the sampling
plan required by § 141.802; or
(ii) Restrict Public Access. In
accordance with paragraph (d) of this
section, restrict public access to the
aircraft water system as expeditiously as
possible, but in no case later than 72
hours after the laboratory notifies the air
carrier of the total coliform-positive and
E. coli-negative result or discovery of
the applicable failure as specified in
paragraphs (f), (g), and, (i) of this
section. All public access restrictions,
including applicable public notification
requirements, must remain in-place
until the aircraft water system has been
disinfected and flushed, and a complete
set of follow-up samples has been
collected. The air carrier must conduct
disinfection and flushing in accordance
with § 141.804(b)(2). After disinfection
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and flushing is completed, the air
carrier must collect follow-up samples
in accordance with paragraph (e) of this
section prior to providing water for
human consumption from the aircraft
water system. A complete set of followup sample results must be total
coliform-negative before the air carrier
returns to the routine monitoring
frequency as specified in the sampling
plan required by § 141.802; or
(iii) Repeat Sampling. Collect three
100 mL repeat samples no later than 24
hours after the laboratory notifies the air
carrier of the routine total coliformpositive and E. coli-negative result.
Repeat samples must be collected and
analyzed from three taps within the
aircraft as follows: The tap which
resulted in the total coliform-positive
sample, one other lavatory tap, and one
other galley tap. If fewer than three taps
exist, then a total of three 100 mL
samples must be collected and analyzed
from the available taps within the
aircraft water system.
(A) If all repeat samples are total
coliform-negative, then the air carrier
must maintain the routine monitoring
frequency for total coliform as specified
in the sampling plan in § 141.802.
(B) If any repeat sample is E. colipositive, the air carrier must perform all
the corrective actions as specified in
paragraphs (c)(2)(i), (c)(2)(ii), and
(c)(2)(iii) of this section.
(C) If any repeat sample is total
coliform-positive and E. coli-negative,
then the air carrier must perform the
corrective actions specified in
paragraphs (c)(3)(i) or (c)(3)(ii) of this
section, and continue through with that
action until a complete set of follow-up
samples is total coliform-negative.
(d) Restriction of public access.
Restriction of public access to the
aircraft water system includes, but need
not be limited to, the following:
(1) Physically disconnecting or
shutting off the aircraft water system,
where feasible, or otherwise preventing
the flow of water through the tap(s);
(2) Providing public notification to
passengers and crew in accordance with
§ 141.805.
(3) Providing alternatives to water
from the aircraft water system, such as
bottled water for drinking and coffee or
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tea preparation; antiseptic hand gels or
wipes in accordance with 21 CFR part
333—‘‘Topical Anti-microbial Drug
Products for Over-the-Counter Human
Use’’ in the galleys 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 unrestricted.
(e) Post Disinfection and Flushing
Follow-up Sampling. Following
corrective action 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 a complete set of
total 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 (b)(4) of this section.
(2) Follow-up samples must be
collected prior to providing water to the
public for human consumption from the
aircraft water system.
(3) If a complete set of follow-up
samples is total coliform-negative, the
air carrier must return to the routine
monitoring frequency for total coliform
as specified in the sampling plan
required by § 141.802.
(4) If any follow-up sample is E. colipositive, the air carrier must perform all
the corrective actions as specified in
paragraphs (c)(2)(i), (c)(2)(ii), and
(c)(2)(iii) of this section.
(5) If any follow-up sample is total
coliform-positive and E. coli-negative
the air carrier must restrict public access
to the aircraft water system in
accordance with paragraph (d) of this
section as expeditiously as possible, but
in no case later than 72 hours after the
laboratory notifies the air carrier of the
total coliform-positive and E. colinegative result. All public access
restrictions, including applicable public
notification requirements, must remain
in-place until the aircraft water system
has been disinfected and flushed in
accordance with § 141.804(b)(2) and a
complete set of follow-up samples is
total coliform-negative. The air carrier
must collect follow-up samples in
accordance with paragraph (e) of this
section. A complete set of follow-up
sample results must be total coliformnegative before the air carrier provides
water for human consumption from the
aircraft water system and returns to the
routine monitoring frequency for
coliform as specified in § 141.802.
(f) Failure to Perform Required
Routine Disinfection and Flushing or
Failure to Collect Required Routine
Samples. If the air carrier fails to
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perform routine disinfection and
flushing or fails to collect and analyze
the required number of routine coliform
samples, the air carrier must perform all
the corrective actions as specified in
paragraph (c)(3)(ii) of this section.
(g) Failure to Collect Repeat or
Follow-up Samples. If the air carrier
fails to collect and analyze the required
follow-up samples as a result of an E.
coli-positive result, then the air carrier
must perform all the corrective actions
as specified in paragraphs (c)(2)(i),
(c)(2)(ii), and (c)(2)(iii) of this section. If
the air carrier fails to collect and
analyze the required repeat samples or
follow-up samples as a result of a total
coliform-positive and E. coli-negative
result, then the air carrier must perform
all the corrective actions as specified in
paragraph (c)(3)(ii) of this section.
(h) Failure to Board Water from a Safe
Watering Point (E. coli-positive). For the
aircraft water system, the air carrier
must perform all the corrective actions
specified in paragraphs (c)(2)(i),
(c)(2)(ii), and (c)(2)(iii) of this section
when it becomes aware of an E. colipositive event resulting from:
(1) Boarding water from a watering
point not in accordance with FDA
regulations (21 CFR part 1240 subpart
E), or
(2) Boarding water that does not meet
NPDWRs applicable to transient noncommunity water systems (§§ 141.62
and 141.63, as applied to TNCWS),
(3) Boarding water that is otherwise
determined to be unsafe due to noncompliance with the procedures
specified in § 141.804(b)(6).
(i) Failure to Board Water from a Safe
Watering Point (non-E. coli-positive).
For the aircraft water system, the air
carrier must perform all the corrective
actions specified in paragraphs (c)(3)(ii)
of this section when it becomes aware
of a non-E. coli-positive event resulting
from:
(1) Boarding water from a watering
point not in accordance with FDA
regulations (21 CFR part 1240, subpart
E),
(2) Boarding water that does not meet
NPDWRs applicable to transient noncommunity water systems (§§ 141.62
and 141.63, as applied to TNCWS), or
(3) Boarding water that is otherwise
determined to be unsafe due to noncompliance with the procedures
specified in § 141.804(b)(6).
§ 141.804 Aircraft water system operations
and maintenance plan.
(a) Each air carrier must develop and
implement an aircraft water system
operations and maintenance plan for
each aircraft water system that it owns
or operates. This plan must be included
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53621
in a Federal Aviation Administration
(FAA)-accepted air carrier operations
and maintenance program (14 CFR part
43, 14 CFR part 91, 14 CFR part 121).
(b) Each aircraft water system
operations and maintenance plan must
include the following:
(1) Watering Point Selection
Requirement. All watering points must
be selected in accordance with Food
and Drug Administration (FDA)
regulations (21 CFR part 1240, subpart
E).
(2) Procedures for Disinfection and
Flushing. The plan must include the
following requirements for 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 is
consistent with, 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 operations 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 choose a disinfection and
flushing, and corresponding monitoring
frequency specified in § 141.803(b)(3).
(3) Follow-up Sampling. The plan
must include the procedures for followup sampling in accordance with
§ 141.803(e).
(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 the following:
(i) Boarding water procedures;
(ii) Sample collection procedures;
(iii) Disinfection and flushing
procedures;
(iv) Public health and safety reasons
for the requirements of this subpart.
(5) Procedures for Conducting Selfinspections of the Aircraft Water
System. Procedures must include, but
are not limited to, inspection of storage
tank, distribution system, supplemental
treatment, fixtures, valves, and backflow
prevention devices.
(6) Procedures for Boarding Water.
The plan must include the following
requirements and procedures for
boarding water:
(i) Within the United States, the air
carrier must board water from watering
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points in accordance with Food and
Drug Administration (FDA) regulations
(21 CFR part 1240, subpart E).
(ii) 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.
(iii) A description of how the carrier
will ensure that water boarded outside
the United States is safe for human
consumption.
(iv) A description of emergency
procedures that meet the requirements
in § 141.803(h) and (i) that must be used
in the event that the air carrier becomes
aware that water was boarded to operate
essential systems, such as toilets, but
was boarded from a watering point not
in accordance with FDA regulations,
does not meet NPDWRs applicable to
transient non-community water systems
(§§ 141.62 and 141.63, as applied to
TNCWSs), or is otherwise unsafe.
(7) Coliform Sampling Plan. The air
carrier must include the coliform
sampling plan prepared in accordance
with § 141.802.
(8) Aircraft Water System Disconnect/
Shut-off, or Prevent Flow of Water
Through the Tap(s) Statement. An
explanation of whether the aircraft
water system can be physically
disconnected/shut-off, or the flow of
water otherwise prevented through the
tap(s) to the crew and passengers.
(c) For existing aircraft, the air carrier
must develop the water system
operations and maintenance plan
required by this section by April 19,
2011;
(d) For new aircraft, the air carrier
must develop the operations and
maintenance plan required in this
section within the first calendar quarter
of initial operation of the aircraft.
(e) Any changes to the aircraft water
system operations and maintenance
plan must be included in the FAAaccepted air carrier operations and
maintenance program.
sroberts on DSKD5P82C1PROD with RULES
§ 141.805
crew.
Notification to passengers and
(a) Air carriers must give public
notice for each aircraft in all of the
following situations:
(1) Public access to the aircraft water
system is restricted in response to a
routine, repeat or follow-up total
coliform-positive or E. coli-positive
sample result in accordance with
§ 141.803(d);
(2) Failure to perform required routine
disinfection and flushing or failure to
collect required routine samples in
accordance with § 141.803(f);
(3) Failure to collect the required
follow-up samples in response to a
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sample result that is E. coli-positive in
accordance with § 141.803(g);
(4) Failure to collect the required
repeat samples or failure to collect the
required follow-up samples in response
to a sample result that is total coliformpositive and E. coli-negative in
accordance with § 141.803(g);
(5) In accordance with § 141.803(h),
the air carrier becomes aware of an E.
coli-positive event resulting from water
that has been boarded from a watering
point not in accordance with FDA
regulations (21 CFR part 1240, subpart
E), or that does not meet NPDWRs
applicable to transient non-community
water systems, or that is otherwise
determined to be unsafe due to noncompliance with the procedures
specified in § 141.804(b)(6);
(6) In accordance with § 141.803(i),
the air carrier becomes aware of a nonE. coli-positive event resulting from
water that has been boarded from a
watering point not in accordance with
FDA regulations (21 CFR part 1240,
subpart E), or that does not meet
NPDWRs applicable to transient noncommunity water systems, or that is
otherwise determined to be unsafe due
to non-compliance with the procedures
specified in § 141.804(b)(6).
(7) The Administrator, the carrier, or
the crew otherwise determines that
notification is necessary to protect
public health.
(b) Public notification:
(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 nonEnglish speaking population served,
including, where applicable, an easily
recognized symbol for non-potable
water.
(c) Public notification for paragraph
(a)(1) of this section must meet the
requirements of paragraph (b) of this
section in addition to the following:
(1) Public notification 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, hand washing, teeth
brushing, or any other consumptive use;
and
(2) A prominent notice in the galley
directed at the crew which includes:
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(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 public
access.
(3) If passenger access to the water
system is physically prevented through
disconnecting or shutting off the water,
or the flow of water prevented through
the tap(s), or if water is supplied only
to lavatory toilets, and not to any
lavatory or galley taps, then only the
notice specified in paragraph (c)(2) of
this section is required.
(4) Air carriers must initiate public
notification when restriction of public
access is initiated in accordance with
§ 141.803(d) and must continue until
the aircraft water system is returned to
unrestricted public access.
(d) Public notification for paragraphs
(a)(2), (a)(4), and (a)(6) of this section
must meet the requirements of
paragraph (b) of this section in addition
to the following:
(1) Public notification 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, 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 clear statement that it is not
known whether the water is
contaminated because there was a
failure to perform required routine
disinfection and flushing; or a failure to
perform required monitoring; or water
was boarded from a watering point not
in accordance with FDA regulations, or
that does not meet NPDWRs applicable
to transient noncommunity water
systems, or that is otherwise determined
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to be unsafe due to noncompliance with
the procedures specified in
§ 141.804(b)(6);
(iii) When and where the unsafe water
was boarded or when 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, 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; and
(vi) A statement indicating when the
system will be disinfected and flushed
and returned to unrestricted public
access.
(3) If passenger access to the water
system is physically prevented through
disconnecting or shutting off the water,
or the flow of water prevented through
the tap(s), or if water is supplied only
to lavatory toilets, and not to any
lavatory or galley taps, then only the
notice specified in paragraph (d)(2) of
this section is required.
(4) Air carriers must initiate public
notification when restriction of public
access is initiated in accordance with
§ 141.803(d) and must continue until
the aircraft water system is returned to
unrestricted public access.
(e) Public notification for paragraphs
(a)(3) and (a)(5) of this section must
meet the requirements of paragraph (b)
of this section in addition to the
following:
(1) Public notification 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, 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 clear statement that the water is
contaminated and there was a failure to
conduct required monitoring; or a clear
statement that water is contaminated
because water was boarded from a
watering point not in accordance with
FDA regulations, or that does not meet
NPDWRs applicable to transient
noncommunity water systems, or that is
otherwise determined to be unsafe due
to noncompliance with the procedures
specified in § 141.804(b)(6);
(iii) A description of the
contaminant(s) of concern;
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(iv) When and where the unsafe water
was boarded or when the specific
monitoring requirement was not met;
(v) Any potential adverse health
effects from the situation, as
appropriate, under paragraph (g) of this
section;
(vi) The population at risk, including
sensitive subpopulations particularly
vulnerable if exposed to the
contaminant in the drinking water;
(vii) A statement indicating what the
air carrier is doing to correct the
situation; and
(viii) When the air carrier expects to
return the system to unrestricted public
access.
(3) If passenger access to the water
system is physically prevented through
disconnecting or shutting off the water,
or the flow of water prevented through
the tap(s), or if water is supplied only
to lavatory toilets, and not to any
lavatory or galley taps, then only the
notice specified in paragraph (e)(2) of
this section is required.
(4) Air carriers must initiate public
notification when restriction of public
access is initiated in accordance with
§ 141.803(d) and must continue public
notification until a complete set of
required follow-up samples are total
coliform-negative.
(f) Public notification for paragraph
(a)(7) of this section must meet the
requirements of paragraph (b) of this
section in addition to the following:
(1) Notification must be in a form and
manner reasonably calculated to reach
all passengers and crew while on board
the aircraft by using one or more of the
following forms of delivery:
(i) Broadcast over public
announcement system on aircraft;
(ii) 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;
(iii) Hand delivery of the notice to
passengers and crew;
(iv) Another delivery method
approved in writing by the
Administrator.
(2) Air carriers must initiate public
notification within 24 hours of being
informed by EPA to perform notification
and must continue notification for the
duration determined by EPA.
(g) In each public notice to the crew,
air carriers must use the following
standard health effects language that
corresponds to the situations in
paragraphs (a)(1) through (a)(6) of this
section.
(1) Health effects language to be used
when public notice is initiated due to
the detection of total coliforms only (not
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53623
E. coli) in accordance with paragraph
(a)(1) of this section:
Coliform are bacteria that are naturally
present in the environment and are used as
an indicator that other, potentially harmful,
bacteria may be present. Coliforms were
found in [INSERT NUMBER OF SAMPLES
DETECTED] samples collected and this is a
warning of potential problems. If human
pathogens are present, they can cause shortterm health effects, such as diarrhea, cramps,
nausea, headaches, or other symptoms. They
may pose a special health risk for infants,
young children, some of the elderly, and
people with severely compromised immune
systems.
(2) Health effects language to be used
when public notice is initiated due to
any E. coli-positive routine, repeat, or
follow-up sample in accordance with
paragraph (a)(1) of this section:
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 public notice is initiated due to a
failure to conduct routine monitoring or
routine disinfection and flushing in
accordance with paragraph (a)(2) of this
section; or when there is a failure to
conduct repeat or follow-up sampling in
accordance with paragraph (a)(4) of this
section; or in accordance with
paragraph (a)(6) of this section, when
the air carrier becomes aware of a nonE. coli-positive event that is the result of
water that was boarded from a watering
point not in accordance with FDA
regulations (21 CFR part 1240, subpart
E), or that does not meet NPDWRs
applicable to transient non-community
water systems, or that is otherwise
determined to be unsafe due to noncompliance with the procedures
specified in § 141.804(b)(6):
Because [REQUIRED MONITORING AND
ANALYSIS WAS NOT CONDUCTED],
[REQUIRED DISINFECTION AND
FLUSHING WAS NOT CONDUCTED]
[WATER WAS BOARDED FROM A
WATERING POINT NOT IN ACCORDANCE
WITH FDA REGULATIONS (21 CR 1240
SUBPART E)], 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.
(4) Health effects language to be used
when public notice is initiated due to a
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failure to conduct required follow-up
monitoring in response to a sample
result that is E. coli-positive in
accordance with paragraph (a)(3) of this
section; or in accordance with
paragraph (a)(5) of this section, when
the air carrier becomes aware of an E.
coli-positive event that is the result of
water that was boarded from a watering
point not in accordance with FDA
regulations (21 CFR part 1240, subpart
E), or that does not meet NPDWRs
applicable to transient non-community
water systems, or that is otherwise
determined to be unsafe due to noncompliance with the procedures
specified in § 141.804(b)(6):
Because required follow-up monitoring
and analysis was not conducted after the
aircraft water system tested positive for E.
coli, we cannot be sure of the quality of the
drinking water at this time. 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.
OR
Water was boarded that is contaminated
with E. coli because [WATER WAS
BOARDED FROM A WATERING POINT
NOT IN ACCORDANCE WITH FDA
REGULATIONS (21 CR 1240 SUBPART E)],
or [OTHER APPROPRIATE EXPLANATION].
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.
sroberts on DSKD5P82C1PROD with RULES
§ 141.806
Reporting requirements.
(a) The air carrier must comply with
the following requirements regarding
reporting of the development of the
coliform sampling plan, the operations
and maintenance plan, and the
disinfection and flushing and coliform
sampling frequencies.
(1) The air carrier must report to the
Administrator that it has developed the
coliform sampling plan required by
§ 141.802, which covers each existing
aircraft water system, as well as report
the frequency for routine coliform
sampling identified in the coliform
sampling plan by April 19, 2011. The air
carrier must report to the Administrator
that it has developed its operations and
maintenance plan required by § 141.804
and report the frequency for routine
disinfection and flushing by April 19,
2011;
VerDate Nov<24>2008
17:06 Oct 16, 2009
Jkt 220001
(2) For each new aircraft meeting the
definition of an aircraft water system,
which becomes operational after
publication of this subpart, the air
carrier must report to the Administrator
that it has developed the coliform
sampling plan required by § 141.802, as
well as report the frequency for routine
coliform sampling identified in the
coliform sampling plan, within the first
calendar quarter of initial operation of
the aircraft. The air carrier must report
to the Administrator that it has
developed the aircraft water system
operations and maintenance plan
required by § 141.804, and report the
frequency for routine disinfection and
flushing 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 April
19, 2011. Inventory information
includes, at a minimum, the following:
(i) The unique aircraft identifier
number;
(ii) The status (active or inactive) of
any aircraft as an aircraft water system
as defined in § 141.801;
(iii) The type and location of any
supplemental treatment equipment
installed on the water system; and
(iv) Whether the aircraft water system
can be physically disconnected or shutoff, or the flow of water prevented
through the tap(s).
(2) Changes in aircraft inventory no
later than 10 days following the
calendar month in which the change
occurred. Changes in inventory
information include, at a minimum, the
following:
(i) Change in the unique identifier
number for any new aircraft, or any
aircraft removed from the carrier’s fleet;
(ii) Change in status (active or
inactive) of any aircraft as an aircraft
water system as defined in § 141.801;
and
(iii) Change to the type and location
of any supplemental treatment
equipment added to or removed from
the water system.
(iv) Change to whether the aircraft
water system can be physically
disconnected or shut-off, or the flow of
water prevented through the tap(s).
(3) All sampling results no later than
10 calendar days following the
monitoring period in which the
sampling occurred. The monitoring
period is based on the monitoring
frequency identified in the coliform
sampling plan required under § 141.802.
Routine disinfection and flushing events
must be reported no later than 10
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Frm 00036
Fmt 4701
Sfmt 4700
calendar days following the disinfection
and flushing period in which the
disinfection and flushing occurred. The
disinfection and flushing period is
based on the frequency identified in the
operations and maintenance plan
required under § 141.804.
(4) All events requiring notification to
passengers or crew, or non-routine
disinfection and flushing, or nonroutine sampling, within 10 days of the
event (e.g., notification of positive
sample result by laboratory), including
information on whether required
notification was provided to passengers
or crew or both.
(5) Failure to comply with the
monitoring or disinfection and flushing
requirements of this subpart within 10
calendar days of discovery of the failure.
(6) Changes in disinfection and
flushing and coliform sampling
frequencies no later than 10 days
following the calendar month in which
the change occurred. Changes to an
aircraft’s routine coliform sampling
frequency and routine disinfection and
flushing frequency must be included in
the aircraft water system operation and
maintenance plan that is included in the
air carrier operations and maintenance
program accepted by FAA in accordance
with § 141.804.
(c) The air carrier must provide
evidence of a self-inspection to the
Administrator within 90 days of
completion of the self-inspection
required under § 141.808(b), including
reporting whether all deficiencies were
addressed in accordance with
§ 141.808(c). The air carrier must also
report to the Administrator within 90
days that any deficiency identified
during a compliance audit conducted in
accordance with § 141.808(a) has 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.
§ 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:
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sroberts on DSKD5P82C1PROD with RULES
(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 and must include the
following information:
(1) The date and time of the
disinfection and flushing; and
(2) The type of disinfection and
flushing (i.e., routine or corrective
action).
(c) The air carrier must keep records
of a self-inspection for at least 10 years
and must include the following
information:
(1) The completion date of the selfinspection; and
(2) Copies of any written reports,
summaries, or communications related
to the self-inspection.
(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 operations 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 copies of
public notices to passengers and crew
issued as required by this subpart for at
least 3 years after issuance.
VerDate Nov<24>2008
17:06 Oct 16, 2009
Jkt 220001
§ 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 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
(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 compliance
audits or routine 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.
PO 00000
Frm 00037
Fmt 4701
Sfmt 4700
§ 141.809
53625
Supplemental treatment.
(a) Any supplemental drinking water
treatment units installed onboard
existing or new aircraft must be
acceptable to FAA and FDA; and must
be installed, operated, and maintained
in accordance with the manufacturer’s
plans and specifications and FAA
requirements.
(b) Water supplemental treatment and
production equipment must produce
water that meets the standards
prescribed in this part.
§ 141.810
Violations.
An air carrier is in violation of this
subpart when, for any aircraft water
system it owns or operates, any of the
following occur:
(a) It fails to perform any of the
requirements in accordance with
§ 141.803 or § 141.804.
(b) It has an E. coli-positive sample in
any monitoring period (routine and
repeat samples are used in this
determination).
(c) It fails to provide notification to
passengers and crew in accordance with
§ 141.805.
(d) It fails to comply with the
reporting and recordkeeping
requirements of this subpart.
(e) It fails to conduct a self-inspection
or address a deficiency in accordance
with § 141.808.
(f) It fails to develop a coliform
sampling plan in accordance with
§ 141.802, or fails to have and follow an
operations and maintenance plan,
which is included in a FAA accepted
program in accordance with § 141.804.
[FR Doc. E9–24552 Filed 10–16–09; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\19OCR2.SGM
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Agencies
[Federal Register Volume 74, Number 200 (Monday, October 19, 2009)]
[Rules and Regulations]
[Pages 53590-53625]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24552]
[[Page 53589]]
-----------------------------------------------------------------------
Part II
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Part 141
National Primary Drinking Water Regulations: Drinking Water Regulations
for Aircraft Public Water Systems; Final Rule
Federal Register / Vol. 74, No. 200 / Monday, October 19, 2009 /
Rules and Regulations
[[Page 53590]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 141
[EPA-HQ-OW-2005-0025; FRL-8967-9]
RIN 2040-AE84
National Primary Drinking Water Regulations: Drinking Water
Regulations for Aircraft Public Water Systems
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency is establishing Federal
drinking water requirements (known as national primary drinking water
regulations or NPDWRs) for aircraft public water systems (hereafter,
aircraft water systems) under the Safe Drinking Water Act (SDWA).
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. This
final rule's requirements are intended to tailor existing health-based
drinking water standards to the unique characteristics of aircraft
water systems for the enhanced protection of public health against
illnesses attributable to microbiological contamination. EPA believes
that this approach 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 disruptions of aircraft flight schedules.
DATES: This rule is effective November 18, 2009. For judicial review
purposes, this final rule is promulgated as of October 19, 2009.
ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OW-2005-0025. All documents in the docket are listed on the
https://www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through https://www.regulations.gov or in hard copy at
the Water Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave.,
NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the Water Docket is (202) 566-2426.
FOR FURTHER INFORMATION CONTACT: Richard Naylor or Cindy Y. Mack,
Drinking Water Protection Division, Office of Ground Water and Drinking
Water (MC-4606M), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone numbers: Richard Naylor
(202) 564-3847 or Cindy Y. Mack (202) 564-6280; e-mail addresses:
naylor.richard@epa.gov or mack.cindy-y@epa.gov. For general
information, contact the Safe Drinking Water Hotline, telephone number:
(800) 426-4791. The Safe Drinking Water Hotline is open Monday through
Friday, excluding legal holidays, from 10 a.m. to 4 p.m., Eastern time.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
Entities potentially regulated by the Aircraft Drinking Water Rule
(ADWR) include air carriers that operate aircraft water systems using
finished surface water, finished ground water under the direct
influence of surface water (GWUDI), or finished ground water. Regulated
categories and entities include:
------------------------------------------------------------------------
Examples of
Category NAICS code regulated entities
------------------------------------------------------------------------
Scheduled passenger air 481111 Air carriers.
transportation.
Nonscheduled chartered passenger 481211 Air carriers.
air transportation.
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could potentially be regulated by this action. Other types of entities
not listed in this table could also be regulated. To determine whether
your air carrier is regulated by this action, you should carefully
examine the applicability criteria in Sec. 141.800 of this final rule.
If you 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. Abbreviations Used in This Notice
ADWR: Aircraft Drinking Water Rule
ANSI: American National Standards Institute
AOCs: Administrative Orders 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
NAICS: North American Industrial Classification System
NCWS: non-community water system
NDWAC: National Drinking Water Advisory Committee
NPDWR: national primary drinking water regulation
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 Administration
[[Page 53591]]
SDWA: Safe Drinking Water Act
SDWIS: Safe Drinking Water Information System
SWTR: Surface Water Treatment Rule
TC: total coliform
TCR: Total Coliform Rule
TCRDSAC: Total Coliform Rule/Distribution System Advisory Committee
TNCWS: transient non-community water system
TT: treatment technique
UMRA: Unfunded Mandates Reform Act
US: United States
UV: Ultra Violet
WHO: World Health Organization
WSG: Water Supply Guidance
WSP: Water Safety Plan
C. Table of Contents
I. General Information
A. Does this Action Apply to Me?
B. Abbreviations Used in This Document
II. Background
A. Legal Authority
B. Purpose of the Rule
C. Scope and Applicability of Rule
D. Regulatory and Enforcement History
III. Final Rule Development
A. Stakeholder Involvement
B. Aircraft Drinking Water Quality
IV. Elements of the Final Aircraft Drinking Water Rule
A. Definitions (Sec. 141.801)
B. Sampling Requirements (Sec. Sec. 141.802 and 141.803)
C. Responses to Sample Results (Sec. 141.803)
D. Restricted Access to the Water System
E. Response to Proposed Rule Requests for Comment
F. Aircraft Water System Operation and Maintenance Plan (Sec.
141.804)
G. Notification Requirements to Passengers and Crew (Sec.
141.805)
H. Reporting Requirements (Sec. 141.806)
I. Recordkeeping Requirements (Sec. 141.807)
J. Audit and Self-Inspection Requirements (Sec. 141.808)
K. Violations (Sec. 141.810)
L. Compliance Date
V. Cost Analysis
A. National Cost Estimates
B. Estimated Impacts of Final ADWR to Air Carrier Passengers
C. Comparison of Costs From Proposed Rule to Final Rule
D. Non-quantified Costs and Uncertainties
VI. Benefits Analysis
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 Tribal 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
M. Congressional Review Act
N. Analysis of the Likely Effect of Compliance With the ADWR on
the Technical, Financial, and Managerial Capacity of Public Water
Systems
VIII. References
II. Background
A. Legal Authority
EPA is finalizing 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 pipes or other constructed conveyances and that
regularly serves an average of at 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
of 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.
EPA's NPDWRs establish different requirements based on the
classification of the public water system (water system), including
whether the system is a ``community,'' ``non-transient non-community,''
or ``transient non-community'' system, and whether the system uses
surface water or groundwater. Aircraft water systems are considered
transient non-community water systems (TNCWS) because they are not
community water systems and they do not regularly serve an average of
at least twenty-five 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.
B. Purpose of the Rule
The primary purpose of the 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 and effective way to
comply with SDWA and the NPDWRs. Due to the unique characteristics of
aircraft water systems and demonstrated implementation challenges, EPA
developed a new NPDWR specifically tailored to aircraft water systems,
the Aircraft Drinking Water Rule (ADWR).
The ADWR has been developed 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.
C. Scope and Applicability of Rule
This final rule 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 final rule applies to the onboard water
system only. EPA defers to the United States Food and Drug
Administration (FDA) with respect to regulating watering points such as
water cabinets, carts, trucks, and hoses from which aircraft board
water.
EPA assumes that only finished water is boarded for human
consumption 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
[[Page 53592]]
based on an FDA requirement that only potable water may be provided for
drinking and culinary purposes on interstate carrier conveyances (ICCs)
(21 CFR 1240.80). However, aircraft water systems that are boarding
water that is not finished water will continue to be subject to
existing NPDWRs.
FDA requirements cover 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. FDA requirements for watering points
do not entail the individual certification of every potential source,
method, facility, or system; however, ICC selected watering points must
be in accordance with FDA requirements (21 CFR part 1240, subpart E).
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 regulated under this final ADWR. EPA also
does not regulate under SDWA water systems that only serve water
outside the U.S. On the April 9, 2008, proposed ADWR, EPA received
public comment as to the applicability of the ADWR to aircraft water
systems based on ownership (e.g., foreign carrier, U.S. military). The
final rule clarifies that the applicability of the ADWR is not based on
ownership, but on the determination as to whether the aircraft water
system is operating within the U.S., meets the definition of a public
water system (PWS) under SDWA section 1401, and is not excluded from
regulation under SDWA section 1411. An aircraft is not considered a
public water system if it does not regularly serve an average of at
least twenty-five individuals daily at least 60 days out of the year.
The ADWR applies to aircraft (regardless of ownership) that fly routes
between two or more locations within the U.S., while the aircraft is
within U.S. jurisdiction. For instance, an aircraft flying an
international route that serves only one U.S. location would not
generally be considered a PWS. Another example is an aircraft that is
used solely for military purposes, is not conveying passengers in
interstate commerce, and meets all of the other exclusion criteria
under SDWA section 1411; in this case, the aircraft would also be
excluded from regulation under the NPDWRs and the ADWR.
An estimated 63 air carriers and 7,327 aircraft water systems are
regulated by this rule.
D. Regulatory and Enforcement History
SDWA, including the amendments of 1986 and 1996, requires EPA to
promulgate NPDWRs to prevent tap water contamination that may adversely
affect human health. As previously noted, aircraft are subject to
certain NPDWRs specific to TNCWS. 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). Since then,
EPA has determined that a new rule, the ADWR, specifically adapted to
aircraft water systems would provide a clearer and more implementable
regulatory framework for aircraft water systems. EPA suspended WSG 29
in 2003 and is no longer approving operation and maintenance programs
in lieu of monitoring.
As discussed in the preamble to the proposed rule (73 FR 19323,
April 9, 2008), 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
under 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 water systems. In the interim, EPA placed 45
air carriers under Administrative Orders on Consent (AOCs) that will
remain in effect until 24 months following publication of the final
rule.
The ADWR adapts to aircraft water systems the applicable
requirements from the Total Coliform Rule (TCR), the suite of surface
water treatment regulations, and the Public Notification 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 fecal coliforms or
E. coli. Fecal coliforms or E. coli indicate more immediate health
risks from sewage or fecal contamination and are used as an indicator
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 five
years for systems that collect fewer than five total coliform samples
per month (those serving 4,100 people or fewer). A TNCWS using surface
water serving less than 1,000 individuals daily would typically be
required to take one total coliform sample per month for routine
sampling requirements.
Under 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.
In addition to the EPA 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. For example, such
programs and practices 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 requirements of aircraft sanitation
systems including potable (finished)
[[Page 53593]]
water, sewage, and galleys. These programs may contribute valuable
information related to the condition of the aircraft water system and
water quality. Throughout the rule's development, EPA has worked
closely with FDA and FAA to ensure that the ADWR is integrated with
these programs to avoid unnecessary duplication.
III. Final Rule Development
A. Stakeholder Involvement
As discussed in the proposed ADWR, EPA announced in 2004 that it
had initiated a rulemaking process to develop regulations for aircraft
water systems. (73 FR 19324, April 9, 2008). The Agency committed to
working collaboratively with other Federal agencies (e.g., FDA and FAA)
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 final ADWR.
EPA 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. This pre-proposal input greatly
assisted EPA in the rule's development.
EPA proposed the ADWR on April 9, 2008 (73 FR 19320), and requested
public comment. The 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.
EPA received comments on the proposal and has made revisions to this
final rule that increases regulatory flexibility and adaptability to
the airline industry's operations, while ensuring public health
protection. Section IV of this notice describes how EPA incorporated
public comments into revisions to the final rule. A Response to
Comments Document is available in the docket for today's action.
B. Aircraft Drinking Water Quality
1. Data Collection Efforts
To better understand aircraft drinking water quality, EPA analyzed
sampling results submitted by air carriers under Administrative Orders
on Consent (AOCs) from 2005-2008. As detailed in the proposed ADWR, EPA
also drew upon the results of the following three studies: (1) A
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 (73 FR 19324).
The AOCs established interim aircraft water testing and
disinfection protocols. As part of the AOCs' requirements, air carriers
were required to submit two documents for EPA approval, which 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. 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 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 [check] [check]
aircraft's water system no less
than quarterly...................
Disinfect and flush watering [check] [check]
points (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 had a pre-AOCs 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.
2. Microbiological Occurrence for the Estimated Baseline
As of December 31, 2008, EPA has processed drinking water sampling
data from 25 of the 45 air carriers under the AOCs. From these 25 air
carriers, EPA processed a total of 20,156 total coliform samples
(13,872 routine and 6,284 repeat) and 17,267 chlorine residual samples.
These 25 air carriers represent 78 percent of the total estimated AOCs'
fleet size (5,558 aircraft) and 79 percent of the total expected annual
number of routine samples. However, data for air carriers with an EPA-
approved QAPP and CRMP are only available from 2 air carriers in 2005,
5 air carriers in 2006, 8 air carriers in 2007, and 12 air carriers in
2008.
The following data summaries are from air carriers with an EPA-
approved QAPP and CRMP. As noted above, not all 25 air carriers
provided data collected under an EPA-approved QAPP and CRMP for all
four years. Therefore, insufficient data are currently available to
support statistical evaluation of the data sets. However, the data were
used to provide an observational indication of trends. It should be
noted that total coliform repeat samples by nature have a higher
probability of being positive since repeat samples are taken after a
routine sample is total coliform-positive. Consequently, the occurrence
baseline for total coliform and E. coli/
[[Page 53594]]
fecal coliform occurrence was based on routine samples only. Table III-
2 presents data for routine total coliform samples collected under EPA-
approved QAPPs and CRMPs.
Of the total 20,156 total coliform samples received, 93 percent or
18,724 samples (12,794 routine and 5,930 repeat samples) were from air
carriers with an EPA-approved QAPP and CRMP. Of the 12,794 routine
samples, 3.6 percent (463 samples) were positive for total coliform and
3.9 percent (18 samples) of the total coliform-positive samples were E.
coli/fecal coliform-positive. Of the 463 total coliform-positive
routine samples, 413 were collected in the lavatory, 47 were collected
in the galley, and one was a composite sample of galley and lavatory
sources; the location of the remaining two positive results are
unknown. Although the lavatory samples had a higher total coliform-
positive occurrence rate (5.9 percent, or 413 of 7,027 lavatory
samples) than the galley samples (0.8 percent, or 47 of 5,695 galley
samples), the galley samples had a higher E. coli/fecal coliform
occurrence of 12.8 percent (6 of 47 total coliform-positive samples),
compared to 2.9 percent (12 of 413 total coliform-positive samples) in
the lavatories. More details on the routine coliform data set by
calendar quarter and by sample collection location on the aircraft are
presented in the following table (Table III-2).
Table III-2--AOCs Occurrence Baseline Data--Routine Total Coliform Samples of Air Carriers With EPA-Approved
QAPPs and CRMPs (Years 2005-2008)
----------------------------------------------------------------------------------------------------------------
Total of TC+ Total of TC+ samples that i> of TC
percent EC+ or samples are EC+ or FC+ samples
FC+
----------------------------------------------------------------------------------------------------------------
Total Coliform Data by Calendar Quarter
----------------------------------------------------------------------------------------------------------------
Calendar Qtr 1.................. 3.2 4.0 100 4 3,145
Calendar Qtr 2.................. 3.5 3.5 198 7 5,641
Calendar Qtr 3.................. 4.1 0.0 79 0 1,930
Calendar Qtr 4.................. 4.1 8.1 86 7 2,078
-------------------------------------------------------------------------------
Total....................... 3.6 3.9 463 18 12,794
----------------------------------------------------------------------------------------------------------------
Total Coliform Data by Sample Location
----------------------------------------------------------------------------------------------------------------
Galley.......................... 0.8 12.8 47 6 5,695
Lavatory........................ 5.9 2.9 413 12 7,027
Composite*...................... 14.3 0 1 0 7
Unknown Sample Site............. 3.1 0 2 0 65
-------------------------------------------------------------------------------
Total....................... 3.6 3.9 463 18 12,794
----------------------------------------------------------------------------------------------------------------
* Composite sample of Galley and Lavatory sources.
Note: ``TC+'' means total coliform-positive; ``EC+ or FC+'' means E. coli-positive or fecal coliform-positive.
Note: For air carriers with EPA-Approved QAPPs and CRMPs (Years 2005-2008), out of a total number of 12,794
routine samples, a total of 18 samples (0.14%) were EC+ or FC+.
3. Residual Chlorine Estimated Baseline
Table III-3 presents data for disinfectant residual samples
collected under EPA-approved QAPPs and CRMPs during routine and repeat
total coliform sampling events. Of the 18,724 routine and repeat total
coliform sample events reported, 16,109 disinfectant residual sample
results were also reported. Results were reported as either ``detect''
with the residual value recorded, or ``non-detect.'' Disinfectant
residual data were not provided for 2,615 coliform sample events.
Disinfectant residual data are presented for the total of routine and
repeat sample collection events because repeat samples have no higher
or lower probability of having a detectable residual than routine
samples.
For air carriers with approved QAPPs and CRMPs, approximately 18.2
percent (2,927 samples) of the 16,109 disinfectant residual results
processed from 2005 to 2008 had a non-detectable disinfectant residual.
Non-detectable levels were similar in galleys (17.3 percent) and
lavatories (18.9 percent), while 22.4 percent (73 out of 326 samples)
of the composite samples were non-detects. A sample location was not
identified for 13 samples with a detectable residual. While not
statistically significant, the occurrence of non-detectable
disinfectant residuals appeared to increase in months with warmer
weather. Quarter 3 (i.e., July to September) had the highest percentage
of samples with a non-detectable disinfectant residual (30.2%),
although as shown in Table III-2, Quarter 3 routine total coliform
sample results showed no appreciable increase in the percentage of
coliform-positive samples.
Table III-3--AOCs Occurrence Baseline Data--Disinfectant Residual Routine and Repeat Samples of Air Carriers
With EPA-Approved QAPPs and CRMPs (Years 2005-2008)
----------------------------------------------------------------------------------------------------------------
Total of i> of i> of
disinfectant disinfectant disinfectant disinfectant
residual non- residual non- residual residual
detect detect detect samples
----------------------------------------------------------------------------------------------------------------
Disinfectant Residual Data by Calendar Quarter
----------------------------------------------------------------------------------------------------------------
Unknown Calendar Qtr............................ 0 0 0 0
Calendar Qtr 1.................................. 22.8 864 2,933 3,797
[[Page 53595]]
Calendar Qtr 2.................................. 9.3 632 6,128 6,760
Calendar Qtr 3.................................. 30.2 813 1,879 2,692
Calendar Qtr 4.................................. 21.6 618 2,242 2,860
---------------------------------------------------------------
Total....................................... 18.2 2,927 13,182 16,109
----------------------------------------------------------------------------------------------------------------
Disinfectant Residual Data by Sample Location
----------------------------------------------------------------------------------------------------------------
Galley.......................................... 17.3 1,336 6,386 7,722
Lavatory........................................ 18.9 1,518 6,530 8,048
Composite *..................................... 22.4 73 253 326
Unknown Sample Site............................. 0.0 0 13 13
---------------------------------------------------------------
Total....................................... 18.2 2,927 13,182 16,109
----------------------------------------------------------------------------------------------------------------
* Composite sample of Galley and Lavatory sources
It appears that a non-detectable disinfectant residual is not
associated with an increase in total coliform-positive samples. Of the
801 total routine and repeat samples that were total coliform-positive,
24 did not include any data on a disinfectant residual. Of the
remaining 777 total coliform-positive routine and repeat samples, 584
samples (75 percent) had a detectable disinfectant residual and 193
samples (25 percent) did not have a detectable disinfectant residual.
Twenty-one (3.6 percent) of the 584 total coliform-positive routine and
repeat samples with a detectable residual (the lowest measuring 0.05
mg/L) also tested positive for E. coli/fecal coliforms. Only one (0.5
percent) of the 193 total coliform-positive samples did not have a
detectable residual and tested positive for E. coli/fecal coliforms.
Seventy-three samples had non-detectable disinfectant residual and
were reported to have carbon filters installed on the water lines to
the sample tap; two of those samples were total coliform-positive. For
comparison, 364 samples with detectable disinfectant residual were
reported to use carbon filters; three of those samples were total
coliform-positive. Aside from charcoal/carbon, and particle removal
filters in some galleys and lavatories, the majority of aircraft do not
provide additional treatment for boarded water.
For more details on aircraft drinking water sample results under
the AOCs, see Chapter 3 and Appendix B of the Economic and Supporting
Analyses for the Final ADWR.
IV. Elements of the Final Aircraft Drinking Water Rule
The following sections describe the elements of the final rule as
developed by EPA. EPA specifically designed the rule to allow air
carriers to be consistent with the manufacturer recommen- dations for
disinfecting and flushing aircraft water systems, instead of
prescribing the frequency, chemical type and concentration to be used.
By allowing air carriers to be consistent with the manufacturer
recommendations for disinfection and flushing, the rule requirements
will automatically evolve with technological improvements in aircraft
water tank lining and piping materials, and as new more effective
disinfectants are developed.
EPA requested comment on all aspects of the rule in its proposal of
April 9, 2008 (73 FR 19320); however, EPA did not request and did 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 the proposed rule. In addition to
rule requirements, EPA identified specific requests for comment on
subject matters pertaining to the proposed rule. The public comment
period for the April 9, 2008, proposed ADWR closed on July 8, 2008. The
following sections of this preamble explain the final rule and present,
when applicable, a summary of the major public comments received. In
addition, EPA has responded to all of the public comments in its
Response to Comment document, which can be found in the docket for this
rule (see ADDRESSES of this notice to obtain information on accessing
the docket).
A. Definitions (Sec. 141.801)
All definitions included in the proposed rule (73 FR 19343), remain
the same in today's final rule except for the definitions for Aircraft
Water System Operations and Maintenance Plan and Watering Point.
In the proposed rule, the definition for Aircraft Water System
Operations and Maintenance Plan reads, ``Aircraft Water System
Operations and Maintenance Plan means the schedules and procedures for
operating, monitoring, and maintaining an aircraft water system that is
included in an aircraft operations and maintenance program approved or
accepted by the Federal Aviation Administration (FAA).'' Since the
publication of the proposed rule, the Agency has learned that FAA does
not ``approve'' the air carrier operations and maintenance programs,
and that describing these programs as ``FAA-accepted'' programs is more
accurate. Thus, in the final rule, EPA removes the word ``approved''
from the definition.
In the proposed rule, the definition for Watering Point reads,
``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.'' However, the Agency received
comments concerning selection of watering points in Sec. 141.804. The
commenters (details under Section IV. F of this notice) believed that
EPA intended to alter Food and Drug Administration (FDA) regulations
applicable to watering points. EPA did not intend to alter these
regulations, and clarifies in today's final rule that it is the
Agency's intent to keep the rule consistent with existing FDA
regulations. Thus, the Agency is revising the definition for Watering
Point to read, ``Watering Point means
[[Page 53596]]
the water supply, methods, and facilities used for delivery of finished
water to the aircraft. These facilities may include water trucks,
carts, cabinets and hoses.''
B. Sampling Requirements (Sec. Sec. 141.802 and 141.803)
This section begins with a summary of the major sampling
requirements of the final ADWR, then addresses public comments received
on the proposed ADWR related to changes EPA has made to the final rule
requirements. Finally, EPA provides responses to the ``Request for
Comment'' issues posed in the proposal designed to aid the Agency in
developing requirements under the final ADWR.
In keeping with the TCR, today's rule reiterates that 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 is not required. In addition, this final rule
specifies that only analytical methodologies approved by EPA are to be
used for sample analysis. For routine total coliform monitoring, each
aircraft water system water sample must be 100 mL. For most systems,
one sample must be collected from a lavatory and one sample from a
galley. Each sample must be analyzed for total coliforms. If total
coliforms are detected, the sample must further be analyzed for E.
coli. Under this rule, E. coli is the indicator that fecal
contamination may have occurred. 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 to
be analyzed for total coliforms. If an aircraft water system has a
removable/portable tank, that is drained at least every day of
passenger service and there is one tap on the aircraft, the air carrier
may collect one 100 mL sample from the available tap (i.e., galley or
lavatory).
1. Coliform Sampling Plan (Sec. 141.802)
EPA proposed to allow six months for air carriers to develop a
coliform sampling plan for each aircraft following publication of the
rule. However, the Agency received several comments requesting that the
compliance date be extended in order to allow more time for air
carriers to restructure maintenance programs between the AOCs and the
final rule. The comments and the Agency's response are explained in
more detail in section IV. L of this notice. EPA agrees that more time
may be needed for air carriers to develop a coliform sampling plan.
Therefore, today's final rule extends the compliance date for
development of the coliform sampling plan to 18 months after
publication of the final rule.
Under the proposed and final rules, an air carrier must develop a
coliform sampling plan for each aircraft water system it owns and
operates. The coliform sampling plan must be included in the Aircraft
Water System Operations and Maintenance Plan required in Sec. 141.804.
The air carrier need not develop a separate coliform sampling plan for
each aircraft, but the air carrier must ensure that each aircraft it
owns and operates is covered by a plan. For example, if the air carrier
operates several of the same type of aircraft water system with the
same coliform sampling frequency, procedures, sampling tap locations,
etc., the air carrier may choose to develop one coliform sampling plan
that applies to all aircraft of this type in the air carrier's fleet.
While most of the sampling plan requirements are the same in the
proposed and final rules, the Agency received comments that the
proposed rule was unclear as to whether and how air carriers could
amend their operations and maintenance plans or their coliform sampling
plans. EPA agrees that the final rule should more clearly state the
requirements for making changes to these plans. Thus, in the final
rule, EPA addresses this concern by clarifying that any subsequent
changes to the coliform sampling plan must also be included in the
Aircraft Water System Operations and Maintenance Plan. Changes to the
coliform sampling plan could include changes to any of the requirements
listed in this section, including changes to the frequency of routine
coliform sample collection. In addition, both the reporting
requirements and the requirements for the operations and maintenance
plan have been revised to respond to these comments.
2. Coliform Sampling Requirements (Sec. 141.803)
In the proposed rule, all air carriers would be required to collect
the same volume and number of samples regardless of aircraft size:
For routine samples--collect two 100 mL samples: one from
a lavatory and one from a galley. If only one tap is available--collect
two ``separate'' 100 mL samples.
For repeat samples--collect four 100 mL samples: one from
the positive tap, one other lavatory, one other galley, and one other
tap. If less than four taps are available--collect four 100 mL samples
from the available taps.
In the proposed rule, routine sampling frequencies were based on
the routine disinfection and flushing frequency as detailed in the
following table (Table IV-1):
Table IV-1--Proposed Rule Requirements for Routine Disinfection and
Flushing and Sampling
------------------------------------------------------------------------
Disinfection & flushing frequency per Coliform sampling frequency
aircraft PWS per aircraft PWS
------------------------------------------------------------------------
Once per Quarter (4 times per year)....... Annually.
Once to 3 times per year.................. Quarterly.
Less than once per year................... Monthly.
------------------------------------------------------------------------
If not specified by the manufacturer, disinfection and flushing must be
no less frequent than once per quarter.
------------------------------------------------------------------------
Public comments on the proposed rule raised several concerns
related to (1) the lavatory as a sampling location site, and (2) the
routine frequencies for disinfection and flushing, and coliform
monitoring. EPA received several public comments regarding the
elimination of lavatory samples. Several commenters stated that
lavatory sampling should be eliminated because it is not representative
of the water actually consumed for drinking purposes on aircraft and,
requiring the sampling of lavatories mischaracterizes risks unless (1)
there are no other sampling locations available on the aircraft; and/or
(2) the airline takes affirmative steps to offer water in the
lavatories for drinking purposes, such as providing drinking cups. EPA
disagrees with these comments. In today's rule, air carriers must
collect a total coliform sample from one galley and one lavatory, when
available. Collection of samples from the lavatory is necessary since
this water may be used for human consumption (e.g., brushing teeth,
hand washing). Additionally, lavatory samples are as representative of
the aircraft drinking water quality as galley samples when proper
collection techniques/procedures are used to minimize the frequency of
positive results due to surface contamination or improper collection
procedures. EPA plans to discuss these issues further in its separate
ADWR technical guidance.
EPA received the following two major comments regarding routine
disinfection and flushing, and coliform monitoring frequencies: (1)
Reduce the sample collection for small volume aircraft water systems
(e.g., regional jets with 5-gallon removable tanks), and (2)
[[Page 53597]]
extend the minimum disinfection intervals to accommodate for less
frequent disinfection based on sampling results.
With respect to sampling number and volume, commenters expressed
concern that the proposed ADWR was unduly complicated (e.g., number of
total coliform samples collected was too much) for small tanks (e.g.,
regional jets with 5 gallons) that are removable/portable and are
drained daily; and that the rule does not account for varying sizes of
aircraft. EPA agrees with the comments regarding aircraft with small
drinking water tanks and today's rule incorporates the following
changes:
For aircraft water systems that have a removable/portable
drinking water tank that is drained every day of passenger service, and
the aircraft has only one tap, air carriers may collect one 100 mL
routine sample from the available tap; and
Collect three 100 mL repeat samples when performing the
corrective action upon the receipt of a total coliform-positive sample.
This reduction in repeat samples also applies to all tank types.
EPA believes these reductions are appropriate because the
complexity of aircraft water systems with removable/portable tanks and
one tap on the aircraft is low (e.g., few feet of tubing/pipes; few
potential points for cross contamination); and the reductions maintain
consistency with the recommendations of the Federal Advisory
Committee--The Total Coliform Rule/Distribution System Advisory
Committee (TCRDSAC)--to reduce sampling volume and frequency for small
non-community stationary systems (see docket for the TCRDSAC Agreement
in Principle, signed September 18, 2008). EPA also believes that the
economic and logistical burden on air carriers, particularly small
regional jets, will be minimized by taking fewer samples.
Public comment on the proposed ADWR disinfection and flushing, and
monitoring frequencies centered around two main issues: (1) Extend the
minimum disinfection intervals to accommodate an approach that focuses
on risk and allows for less frequent disinfection based on sampling
results, and (2) set ``reasonable minimum'' disinfection timelines
consistent with the AOCs of some major air carriers to align a semi-
annual disinfection schedule with an annual sampling schedule, thereby
reducing the ``significant'' economic cost to restructure in-place
disinfection programs. EPA agrees that some changes are warranted and
today's rule includes revised requirements to the routine frequencies
as presented in Table IV-2:
Table IV-2--Final Rule Requirements for Routine Disinfection and
Flushing and Routine Sampling Frequencies
------------------------------------------------------------------------
Minimum routine disinfection & flushing Minimum frequency of routine
per aircraft samples per aircraft
------------------------------------------------------------------------
At least 4 times per year = At least At least 1 time per year = At
once within every three-month period least once within every twelve-
(quarterly). month period (annually).
At least 3 times per year = At least At least 2 times per year = At
once within every four-month period. least once within every six-
month period (semi-annually).
At least 2 times per year = At least At least 4 times per year = At
once within every six-month period least once within every three-
(semi-annually). month period (quarterly).
At least 1 time per year or less = At At least 12 times per year = At
least once within every twelve-month least once every month
period (annually) or less. (monthly).
------------------------------------------------------------------------
If not specified by the manufacturer, select any frequency that is no
less stringent than these four disinfection and flushing frequencies
which meet the aircraft's unique operational needs.
------------------------------------------------------------------------
EPA considers disinfection and flushing to be a more protective and
pro-active public health measure than monitoring. Therefore, EPA re-
aligned the disinfection and flushing and monitoring frequencies in
order to emphasize the importance of disinfection and flushing in
comparison to monitoring. As a result, those air carriers that conduct
more frequent disinfection and flushing do not have to monitor as
frequently. Today's final rule requires an air carrier that conducts
disinfection and flushing three times per year to perform sampling
twice a year instead of four times per year. And an air carrier that
conducts disinfection and flushing once per year or less must sample
monthly. With respect to the commenter's concern about accommodating a
semi-annual disinfection and flushing frequency with annual sampling
(as allowed under some AOCs), the ADWR continues to accommodate the
semi-annual disinfection and flushing schedule. However, EPA believes
that linking this with annual sampling would be inconsistent with the
importance of disinfection and flushing as the preferred, pro-active
measure. As reflected in Table IV-2, today's rule continues to require
air carriers that conduct disinfection and flushing semi-annually to
conduct monitoring four times per year.
While the frequencies in Table IV-2 provide air carriers with
enough flexibility to schedule both routine disinfection and flushing
and routine monitoring in a way that avoids disruption to passenger
service, EPA intends for air carriers to schedule routine disinfection
and flushing and routine monitoring at regular intervals throughout the
calendar year. Routine disinfection and flushing should be scheduled so
that the amount of time between each disinfection and flushing event is
approximately equal. EPA believes that this will maximize the
effectiveness of the disinfection and flushing event. Similarly,
routine monitoring should be scheduled so that the amount of time
between each monitoring event is approximately equal. EPA does not
intend for routine disinfection and flushing events to take place back-
to-back such that disinfection and flushing occurs at the end of one
disinfection and flushing period and again at the beginning of the
following period. Nor should air carriers schedule routine monitoring
events to take place back-to-back such that samples are taken at the
end of one monitoring period and again at the beginning of the
following period.
In addition, the Agency received comment that the requirement to
disinfect and flush quarterly, when no manufacturer recommendations
were available, did not provide flexibility. In today's rule, EPA
removed this requirement (as reflected in Table IV-2) so that when
there is no manufacturer recommendation, air carriers can select any of
the routine frequencies that best
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meet their unique operations and maintenance needs.
EPA was unable to make a determination on a risk-based approach
that supports a reduced frequency for disinfection and flushing based
on sampling results, because no new data were provided beyond the AOCs'
data. The AOCs' data protocols were not designed to establish risk-
based frequencies. AOCs are interim measures used to aid air carriers
to meet compliance with SDWA and provide an understanding of aircraft
drinking water quality. At this time, EPA believes the final rule
frequencies provide the minimum requirements necessary for public
health protection, while also providing adequate flexibility to meet
the evolving needs of the industry, such as transitioning from the
AOCs' requirements to the ADWR.
3. Analytical Methods (Sec. 141.803(a))
In the proposed rule, EPA stated that air carriers must use EPA-
approved analytical methodologies for the analysis of coliform
bacteria. Public comment was received regarding the specific use of
concurrent analytical methods that test for total coliforms and E. coli
simultaneously. The commenter named several concurrent methods that
they felt provide ``great benefit'' to the industry, because the
methods are timely and accurate. Although some of these noted methods
are EPA-approved, the final rule reiterates and clarifies that air
carriers must use only the EPA-approved analytical methods for
analyzing total coliforms and/or E. coli in drinking water samples as
specified in Sec. 141.21(f)(3) and Sec. 141.21(f)(6) of the Code of
Federal Regulations, or their equivalent as approved by EPA to
demonstrate compliance with the ADWR sampling requirements. EPA has
approved several methods for use that allow the simultaneous detection
of both total coliforms and E. coli. These methods are also approved
for use under this rule.
In the proposed rule, EPA required air carriers to use a State- or
EPA-certified laboratory for analysis of drinking water samples. For
compliance with the ADWR, one commenter encouraged EPA to allow the use
of foreign laboratories to conduct analysis on drinking water samples
as permitted under the Administrative Orders on Consent (AOCs). In
addition, the commenter noted that air carriers should be allowed to
conduct disinfection of their aircraft water systems ``at locations
outside the U.S.'' The final rule clarifies and reiterates that
drinking water microbiological samples submitted for compliance with
the ADWR must be analyzed by a certified laboratory to ensure the use
of approved analytical methods and approved quality control procedures
for checking analytical data for completeness and correctness. A
certified laboratory is a laboratory that is certified by EPA or a
State. ``State'' refers to a U.S. State or Tribe that has received
primacy for public water systems (other than aircraft water systems)
under section 1413 of the SDWA. By allowing the use of any laboratory
that is certified by a State or EPA for analysis of drinking water
samples, the ADWR provides air carriers with greater flexibility in
designing their sampling programs while maintaining protection of
public health.
In one AOC, for a specific set of the fleet (i.e., 47 aircraft) an
air carrier was permitted to use a foreign laboratory, which was
neither EPA- nor State-certified, to perform analysis of drinking water
samples provided that the samples were analyzed using EPA- approved
analytical methods. The commenter incorrectly assumed that this
allowance would fulfill SDWA compliance. In today's notice, the Agency
makes clear that this allowance was not intended for compliance
purposes under the SDWA. The ADWR does not prevent collection of
samples outside the U.S. However, foreign laboratories must be an EPA-
or a State-certified laboratory in order to analyze the drinking water
samples for compliance with the ADWR. EPA plans on addressing these
issues in more detail in its ADWR technical guidance. EPA notes that
the ADWR requirements do not prevent air carriers from performing
disinfection and flushing outside the U.S. for compliance with the
ADWR.
C. Responses to Sampling Results (Sec. 141.803)
As specified in the proposed rule, air carriers would 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. Under the proposal, upon
receipt of a total coliform-positive result, air carriers would be
required to further analyze the positive sample for the presence of
fecal coliforms, except that the system could test for E. coli in lieu
of fecal coliforms. EPA received public comment requesting the removal
of fecal coliforms as indicators. EPA agrees with this comment and
today's rule eliminates the use of fecal coliforms as indicators of
potential fecal contamination. As a consequence, the final rule
specifies that upon receipt of a total coliform-positive result, air
carriers must further analyze that sample for E. coli only. The fecal
coliform group (also referred to as thermotolerant coliforms) has been
found to sometimes contain environmental bacteria that are not of fecal
origin. Thus, the presence of fecal coliform bacteria in a water sample
is not necessarily indicative of the potential for fecal contaminants
being present. Thus, analyzing for E. coli provides more meaningful
data to protect public health. This change is consistent with the
recommendations of the Federal Advisory Committee--TCRDSAC.
In the proposed rule, air carriers would be required to perform the
following corrective actions based on a positive coliform result:
(1) If one routine sample was total coliform-positive and E. coli/
fecal coliform-negative then the air carrier would be required to:
Within 72 hours of receipt of the positive result from the
laboratory, disinfect and flush the water system, and collect follow-up
samples; or
Within 24 hours of receipt of the positive result from the
laboratory, collect four repeat samples.
(2) If two or more routine samples or any repeat samples were total
coliform-positive and E. coli/fecal coliform-negative, or if any sample
was E. coli/fecal coliform-positive then the air carrier was required
to:
Within 24 hours of receipt of the positive result from the
laboratory, restrict public access. Restrict public access included the
following activities for the aircraft in question: Physically
disconnect or shut-off the water system where feasible; provide public
notification to passengers and crew if the water system could not be
shut-off, but if the system could be shut-off, then provide public
notice to the crew only; and provide alternatives to the use of the
water system such as antiseptic alcohol-based hand gels or wipes and
bottled water (that reduce or eliminate the need to use the water
system during the limited period before access is restored); and
Within 72 hours of receipt of the positive result from th