19 October 2009
[Federal Register: October 19, 2009 (Volume 74, Number 200)]
[Rules and Regulations]
[Page 53589-53625]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc09-16]
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Part II
Environmental Protection Agency
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40 CFR Part 141
National Primary Drinking Water Regulations: Drinking Water Regulations
for Aircraft Public Water Systems; Final Rule
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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.
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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
http://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 http://www.regulations.gov or in hard copy at
the Water Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave.,
NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the Water Docket is (202) 566-2426.
FOR FURTHER INFORMATION CONTACT: Richard Naylor 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
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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
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
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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, 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)
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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 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
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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.....................
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\1\ The air carrier was required to use State- or EPA-certified
laboratories and EPA-approved analytical methods for analyzing
drinking water samples.
\2\ If the air carrier 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/
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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) 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
[[Page 53598]]
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 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
[[Page 53599]]
airspace disruptions that may occur when an aircraft cannot be pulled
out-of-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 coliform-positive 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 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 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
(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 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,
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 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.
As compared to the proposed ADWR, the changes made to the
aforementioned
[[Page 53600]]
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 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 follow-up 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 follow-up 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 follow-up 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. coli-positive 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 non-community water
systems when there is an E. coli-positive event); and (2) a non-fecal
occurrence (e.g., total coliform-positive and E. coli-negative event,
or boards water that does not meet NPDWRs applicable to transient non-
community 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
coliform-positive/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:
[cir] Conduct the Restrict Public Access requirements within 72
hours, and
[cir] 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 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.
[cir] If any follow-up sample is E. coli-positive, the air carrier
must follow all the corrective actions for an E. coli-positive result.
These actions must continue until a set of follow-up samples is total
coliform-negative.
[[Page 53601]]
When the air carrier becomes aware that it has failed to collect the
required follow-up samples due to an E. coli-positive 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 coliform-negative.
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 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 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 follow-up 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 fecal-occurrence (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
[[Page 53602]]
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
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, 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 retro-fitting 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 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'
[[Page 53603]]
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 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. coli- negative
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 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 booster-disinfection 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.
[[Page 53604]]
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 coliform- or 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 72-hour 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.
coli-negative 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 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-to-know. Hence, public notification is an emphasized
component of this option. However, EPA considers an E. coli-positive
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 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
[[Page 53605]]
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 re-commence
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 risk-based 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 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 (Sec.
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 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
[[Page 53606]]
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 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 non-
community 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 FDA-approved 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 with the procedures for boarding water specified in the
operations and maintenance plan.
G. Notification Requirements to Passengers and Crew (Sec. 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. coli-positive
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 Sec. 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 coliform-positive 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 Sec. 141.810
(i.e., Violations) conflict with the situations listed in proposed
Sec. 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 Sec. 141.810 or make
conforming changes to the two sections. EPA agrees that the reference
to public notification requirements in Sec. 141.805 is confusing and
inconsistent with Sec. 141.810. Therefore, EPA removed all references
to public notification from Sec. 141.810 and made conforming changes
[[Page 53607]]
to Sec. 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 FDA-
approved watering points in Sec. 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 Sec. 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
non-compliance with the procedures specified in Sec. 141.804(b)(6).
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 coliform-negative. As a
result of clarifications made to the corrective action requirements in
Sec. 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 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 coliform-positive 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 coliform-positive
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 coliform-positive 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, 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 Sec. 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 Sec. 141.805 to the restructured corrective action
requirements in Sec. 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 Sec. 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 (Sec. 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
[[Page 53608]]
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 Sec. 141.801.
In addition, EPA corrects the final rule by adding Sec.
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
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 Sec. 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 Sec. 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 Sec. 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 non-routine sampling.
I. Recordkeeping Requirements (Sec. 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 to disinfection and flushing and self-inspections 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 self-inspections.'' 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 self-inspection.
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
[[Page 53609]]
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.
J. Audit and Self-Inspection Requirements (Sec. 141.808)
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 (Sec. 141.810)
The Agency received several comments on the proposed rule stating
that the notification requirements in Sec. 141.810 conflict with the
notification requirements proposed in Sec. 141.805, and that to avoid
confusion and inconsistency, EPA should delete the public notification
requirements in this section or make conforming changes to both
sections. EPA agrees that the reference to public notification
requirements in this section is confusing and inconsistent with Sec.
141.805. Therefore, as noted previously, EPA removed all references to
public notification from Sec. 141.810 and made conforming changes to
Sec. 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.
L. Compliance Date
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 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 18-month 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 10 days
Within the Within the following the Beginning 24
first 18 months first calendar calendar month months after
Requirement following quarter of in which the publication of
publication of initial change the final rule
the final rule operation occurred
----------------------------------------------------------------------------------------------------------------
Aircraft Water System Operations and
Maintenance Plan:
Existing \1\ Aircraft--develop the plan X ............... ............... ...............
and report that it has been developed..
New \2\ Aircraft--develop the plan and ............... X ............... ...............
report that it has been developed......
Aircraft Coliform Sampling Plan:
Existing \1\ Aircraft--develop the plan X ............... ............... ...............
and report that it has been developed..
New \2\ Aircraft--develop the plan and ............... X ............... ...............
report that it has been developed......
Aircraft Frequency of Coliform Sampling and
Routine Disinfection and Flushing:
Existing \1\Aircraft--report the routine X ............... ............... ...............
frequency..............................
New \2\ Aircraft--report the routine ............... X ............... ...............
frequency..............................
Report any change \3\ in routine ............... ............... X ...............
frequency..............................
Aircraft Inventory:
Existing Aircraft--report the inventory. X ............... ............... ...............
[[Page 53610]]
Report any change \3\ to aircraft ............... ............... X ...............
inventory..............................
Aircraft Routine Requirements:
Conduct routine monitoring.............. ............... ............... ............... X
Conduct routine disinfection and ............... ............... ............... X
flushing...............................
----------------------------------------------------------------------------------------------------------------
\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
systems. EPA also considered certain aspects of the ADWR that are non-
quantified 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 $6.95 million at a 7
percent discount rate. Table V-1 presents the itemized and total
annualized implementation costs to air carriers (airlines) and EPA for
the ADWR at 3 and 7 percent discount rates. Unit costs were multiplied
by the number of air carriers or aircraft performing each requirement
of the final rule, and results were summed for all components.
Table V-1--Total Annualized Present Value Implementation Costs for the Final ADWR
[$Millions, 2008$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Air carriers Agency Total Air carriers Agency Total
-----------------------------------------------------------------------------------------------
3%
7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation.......................................... $0.002 $0.01 $0.01 $0.004 $0.01 $0.02
Annual Administration................................... .............. 0.24 0.24 .............. 0.23 0.23
Sampling Plan........................................... 0.002 0.001 0.002 0.002 0.001 0.003
O&M Plan................................................ 0.01 0.0001 0.01 0.02 0.0001 0.02
Coliform Monitoring..................................... 4.89 0.04 4.93 4.82 0.04 4.86
Routine Disinfection and Flushing....................... 2.08 .............. 2.08 2.05 .............. 2.05
Corrective Action Disinfection and Flushing............. 0.05 .............. 0.05 0.05 .............. 0.05
Compliance Audit........................................ 0.01 0.01 0.02 0.01 0.01 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 $21.83 million
at a 7 percent discount rate, as presented in Table V-2. The
incremental savings represent the difference in total annualized
implementation costs between the baseline (i.e., the existing NPDWRs)
and the final rule provisions.
Table V-2--Total Annualized Incremental Cost: Existing NPDWRs and the ADWR
[$Millions, 2008$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alt 1 Alt 4 (Final Incremental Alt 1 Alt 4 (Final Incremental
(Existing Rule) Cost (Alt 4- (Existing Rule) Cost (Alt 4-
NPDWRs) Alt 1) NPDWRs) Alt 1)
-----------------------------------------------------------------------------------------------
3%
7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 53611]]
Implementation.......................................... 0.01 0.01 0 0.02 0.02 0
Annual Administration................................... 0.24 0.24 0 0.23 0.23 0
Monitoring Plan......................................... 0.002 0.002 0 0.004 0.003 (0.001)
O&M Plan................................................ .............. 0.01 0.01 .............. 0.02 0.02
Coliform Monitoring..................................... 25.37 4.93 (20.44) 25.02 4.86 (20.16)
Disinfectant Residual Monitoring........................ 3.17 .............. (3.17) 3.13 .............. (3.13)
Routine Disinfection and Flushing....................... .............. 2.08 2.08 .............. 2.05 2.05
Corrective Action Disinfection and Flushing............. .............. 0.05 0.05 .............. 0.05 0.05
Sanitary Survey/Compliance Audit........................ 0.7 0.02 (0.68) 0.69 0.02 (0.67)
Turbidity Monitoring.................................... .............. .............. .............. .............. .............. ..............
-----------------------------------------------------------------------------------------------
Total............................................... 29.49 7.34 (22.15) 29.08 7.25 (21.83)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
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 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 $7.25 million (year 2008 dollars, using 3 and 7 percent discount
rates, respectively). The costs reported for the ADWR are from Table V-
1; the costs for the proposed rule include adjustments for the general
cost assumptions and methodology applied to the ADWR (e.g., labor
rates), with all costs adjusted to 2008 dollars.
Table V-3--Comparison of Proposed and Final ADWR Total Annualized Present Value Implementation Costs
[$Millions, 2008$]
----------------------------------------------------------------------------------------------------------------
3% Proposal 3% Final 7% Proposal 7% Final
----------------------------------------------------------------------------------------------------------------
Implementation.......................................... 0.01 0.01 0.01 0.02
Annual Administration................................... 0.25 0.24 0.25 0.23
Monitoring Plan......................................... 0.002 0.002 0.004 0.003
O&M Plan................................................ 0.01 0.01 0.02 0.02
[[Page 53612]]
Coliform Monitoring..................................... 5.50 4.93 5.57 4.86
Routine Disinfection and Flushing....................... 2.21 2.08 2.23 2.05
Corrective Action Disinfection and Flushing............. 0.13 0.05 0.13 0.05
Compliance Audit........................................ 0.02 0.02 0.02 0.02
-------------------------------------------------------
Total............................................... * 8.13 7.34 * 8.24 7.25
----------------------------------------------------------------------------------------------------------------
* 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.
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; follow-up 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 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
coliform-positive.
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.
[[Page 53613]]
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.
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
----------------------------------------------------------------------------------------------------------------
Corrective Total number
Routine Routine action of
coliform disinfection disinfection disinfection
monitoring and flushing and flushing and flushing
events/year events/year events/year events/year
A B C D=B+C
----------------------------------------------------------------------------------------------------------------
Proposed Rule................................... 26,593 20,516 1,175 21,691
Final Rule...................................... 25,436 20,516 395 20,911
----------------------------------------------------------------------------------------------------------------
(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 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 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:
[[Page 53614]]
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 self-inspections above what is
necessary for FAA-related inspections.
Labor burden and costs associated with correcting
significant deficiencies that are identified during self-inspections
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 under-estimate 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 coliform-positive 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 record-keeping burden, no additional costs for self-
inspections are incurred by air carriers. Labor burden for self-
inspections, which involve a thorough review and inspection of an
aircraft water system as well as addressing any deficiencies, is
already captured under current FAA requirements and therefore 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 self-inspections. 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 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 immuno-compromised, 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.
[[Page 53615]]
VII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order (EO) 12866, (58 FR 51735, October 4, 1993),
this action is a ``significant regulatory action.'' 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 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 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-for-
profit enterprise which is independently owned and operated and is not
dominant in its field.'' However, the RFA also authorizes an agency to
use alternative definitions for each category of small entity, ``which
are appropriate to the activities of the agency'' after proposing the
alternative definition(s) in the Federal Register and taking comment. 5
U.S.C. 601(3)-(5). In addition, to establish an alternative small
business definition, agencies must consult with SBA's Chief Counsel for
Advocacy.
For purposes of assessing the 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
[[Page 53616]]
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 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 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 non-community water
systems. At present, EPA has not identified any Tribal governments that
may be owners/air carriers of such systems. Thus, Executive Order 13175
does not apply to this action.
[[Page 53617]]
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.
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 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 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
[[Page 53618]]
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.
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. http://www.airlines.org.
Canada. 2007a. Health Canada. Healthy Living. Aircraft Inspection
Program--Frequently Asked Questions. http://www.hc-sc.gc.ca/hl-vs/
travel-voyage/general/inspection/airplane-aeronefs_e.html.
Canada. 2007b. Health Canada. Healthy Living. Advisory. Health
Canada cautions air travelers with compromised immune systems
regarding water quality on aircraft. http://www.hc-sc.gc.ca/ahc-asc/
media/advisories-avis/2006/2006_53_e.html.
Davison, A., Howard, G., Stevens, M., et al. 2005. Water, Sanitation
and Health Protection and the Human Environment, World Health
Organization, Geneva. Water Safety Plans: Managing drinking-water
quality from catchment to consumer. http://www.who.int/water_
sanitation_health/.
Lehtola, M., Torvinen, E., Kusnetsov, J., et al. 2007. Survival of
Mycrobacterium avium, Legionella pneumophila, Escherichia coli, and
Caliciviruses in Drinking Water-Associated Biofilms Grown under
High-Shear Turbulent Flow. Applied and Environmental Microbiology,
73:2854-2859.
USEPA. 1986. Water Supply Guidance 29: Plan for Implementation of
the Safe Drinking Water Act on Interstate Carrier Conveyance.
USEPA. 1989. National Interim Primary Drinking Water Regulations;
Total Coliform Rule; Final Rule. Part III. Federal Register,
54:124:27544. (June 29, 1989).
USEPA. 2008. Economic and Supporting Analyses; 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. http://
www.accessdata.fda. gov/.
WHO. 1997. HACCP--Introducing the Hazard Analysis and Critical
Control Point System. Geneva, Switzerland: WHO.
WHO. 2004. Guidelines for Drinking-Water Quality. 3rd Edition,
Volume 1--Recommendations, Chapter 4 Water Supply Plans. Geneva,
Switzerland: WHO.
List of Subjects in 40 CFR Part 141
Environmental protection, Chemicals, Indian-lands,
Intergovernmental relations, Radiation protection, Reporting and
recordkeeping requirements, Water supply.
Dated: October 5, 2009.
Lisa P. Jackson,
Administrator.
0
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
0
1. The authority citation for part 141 continues to read as follows:
Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4,
300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.
0
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
Sec. 141.800 Applicability and compliance date.
(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.
Sec. 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
[[Page 53619]]
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.
Sec. 141.802 Coliform sampling plan.
(a) Each air carrier under this subpart must develop a coliform
sampling plan covering each aircraft water system owned or operated by
the air carrier that identifies the following:
(1) Coliform sample collection procedures that are consistent with
the requirements of Sec. 141.803(a) and (b).
(2) Sample tap location(s) representative of the aircraft water
system as specified in Sec. 141.803(b)(2) and (b)(4).
(3) Frequency and number of routine coliform samples to be
collected as specified in Sec. 141.803(b)(3).
(4) Frequency of routine disinfection and flushing as specified in
the operations and maintenance plan under Sec. 141.804.
(5) Procedures for communicating sample results promptly so that
any required actions, including repeat and follow-up sampling,
corrective action, and notification of passengers and crew, 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 Sec. 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 Sec. 141.804.
Sec. 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 Sec.
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[deg]C during transit.
(5) The invalidation of a total coliform sample result can be made
only by the Administrator in accordance with Sec. 141.21(c)(1)(i),
(ii), or (iii) or by the certified laboratory in accordance with Sec.
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
Sec. 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 Sec. 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 Sec. 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):
Table B-1--Routine Disinfection and Flushing and Routine Sample
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).
[[Page 53620]]
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).
------------------------------------------------------------------------
(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
coliform-positive, 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 Sec. 141.802.
(2) Positive Routine E. coli Sample Results. If any routine sample
is E. coli-positive, 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 Sec. 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 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 Sec. 141.802.
(3) Positive Routine Total Coliform Sample Results. If any routine
sample is total coliform-positive and E. coli-negative, 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 Sec. 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. coli-negative 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
follow-up 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 Sec. 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 Sec. 141.804(b)(2). 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 follow-up 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 Sec. 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 coliform-positive 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 Sec. 141.802.
(B) If any repeat sample is E. coli-positive, 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 Sec. 141.805.
(3) Providing alternatives to water from the aircraft water system,
such as bottled water for drinking and coffee or
[[Page 53621]]
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 Sec. 141.802.
(4) If any follow-up sample is E. coli-positive, 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. coli-negative 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 Sec. 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 coliform-
negative 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 Sec. 141.802.
(f) Failure to Perform Required Routine Disinfection and Flushing
or Failure to Collect Required Routine Samples. If the air carrier
fails to 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. coli-positive 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 non-community water systems (Sec. Sec. 141.62 and 141.63, as
applied to TNCWS),
(3) Boarding water that is otherwise determined to be unsafe due to
non-compliance with the procedures specified in Sec. 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 non-community water systems (Sec. Sec. 141.62 and 141.63, as
applied to TNCWS), or
(3) Boarding water that is otherwise determined to be unsafe due to
non-compliance with the procedures specified in Sec. 141.804(b)(6).
Sec. 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 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 Sec.
141.803(b)(3).
(3) Follow-up Sampling. The plan must include the procedures for
follow-up sampling in accordance with Sec. 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 Self-inspections of the Aircraft
Water System. Procedures must include, but are not limited to,
inspection of storage tank, distribution system, supplemental
treatment, fixtures, valves, and backflow prevention devices.
(6) Procedures for Boarding Water. 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
[[Page 53622]]
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 Sec. 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 (Sec. Sec. 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 Sec. 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 FAA-accepted air carrier
operations and maintenance program.
Sec. 141.805 Notification to passengers and crew.
(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 Sec. 141.803(d);
(2) Failure to perform required routine disinfection and flushing
or failure to collect required routine samples in accordance with Sec.
141.803(f);
(3) Failure to collect the required follow-up samples in response
to a sample result that is E. coli-positive in accordance with Sec.
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 coliform-positive and E. coli-negative in accordance with
Sec. 141.803(g);
(5) In accordance with Sec. 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 non-compliance with the procedures
specified in Sec. 141.804(b)(6);
(6) In accordance with Sec. 141.803(i), the air carrier becomes
aware of a non-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 non-compliance with the
procedures specified in Sec. 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 non-English 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:
(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 Sec. 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
[[Page 53623]]
to be unsafe due to noncompliance with the procedures specified in
Sec. 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 Sec. 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 Sec. 141.804(b)(6);
(iii) A description of the contaminant(s) of concern;
(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 Sec. 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 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 short-term health effects, such as diarrhea, cramps, nausea,
headaches, or other symptoms. They may pose a special health risk
for infants, young children, some of the elderly, and people with
severely compromised immune systems.
(2) Health effects language to be used when 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 non-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 non-compliance with the
procedures specified in Sec. 141.804(b)(6):
Because [REQUIRED MONITORING AND ANALYSIS WAS NOT CONDUCTED],
[REQUIRED DISINFECTION AND FLUSHING WAS NOT CONDUCTED] [WATER WAS
BOARDED FROM A WATERING POINT NOT 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
[[Page 53624]]
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 non-
compliance with the procedures specified in Sec. 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.
Sec. 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 Sec. 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 Sec. 141.804 and report the frequency for routine
disinfection and flushing by April 19, 2011;
(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 Sec. 141.802, as well
as report the frequency for routine coliform sampling identified in the
coliform sampling plan, within the first calendar quarter of initial
operation of the aircraft. The air carrier must report to the
Administrator that it has developed the aircraft water system
operations and maintenance plan required by Sec. 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 Sec. 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 shut-off, 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 Sec. 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 Sec. 141.802. 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. The disinfection and flushing
period is based on the frequency identified in the operations and
maintenance plan required under Sec. 141.804.
(4) All events requiring notification to passengers or crew, or
non-routine disinfection and flushing, or non-routine 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 Sec. 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 Sec. 141.808(b), including reporting whether all
deficiencies were addressed in accordance with Sec. 141.808(c). The
air carrier must also report to the Administrator within 90 days that
any deficiency identified during a compliance audit conducted in
accordance with Sec. 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.
Sec. 141.807 Recordkeeping requirements.
(a) The air carrier must keep records of bacteriological analyses
for at least 5 years and must include the following information:
[[Page 53625]]
(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 self-inspection; 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.
Sec. 141.808 Audits and inspections.
(a) The Administrator may conduct routine compliance audits as
deemed necessary in providing regulatory oversight to ensure proper
implementation of the requirements in this subpart. Compliance audits
may include, but are not 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.
Sec. 141.809 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.
Sec. 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
Sec. 141.803 or Sec. 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 Sec. 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 Sec. 141.808.
(f) It fails to develop a coliform sampling plan in accordance with
Sec. 141.802, or fails to have and follow an operations and
maintenance plan, which is included in a FAA accepted program in
accordance with Sec. 141.804.
[FR Doc. E9-24552 Filed 10-16-09; 8:45 am]
BILLING CODE 6560-50-P
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