[Federal Register: April 9, 2008 (Volume 73, Number 69)] [Proposed Rules] [Page 19319-19348] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ap08-17] [[Page 19319]] ----------------------------------------------------------------------- Part III Environmental Protection Agency ----------------------------------------------------------------------- 40 CFR Part 141 National Primary Drinking Water Regulations: Drinking Water Regulations for Aircraft Public Water Systems; Proposed Rule [[Page 19320]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 141 [EPA-HQ-OW-2005-0025; FRL-8551-3] RIN 2040-AE84 National Primary Drinking Water Regulations: Drinking Water Regulations for Aircraft Public Water Systems AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The Environmental Protection Agency is proposing to amend and consolidate in one place the federal drinking water requirements (known as National Primary Drinking Water Regulations or NPDWRs) for aircraft public water systems under the Safe Drinking Water Act (SDWA). Aircraft public water systems are subject to the requirements of SDWA and the NPDWRs. The existing federal drinking water standards were primarily designed to regulate water quality in stationary public water systems and the application of these requirements to mobile water systems with the capability of flying throughout the world has created implementation challenges. The proposed requirements are intended to tailor existing health-based drinking water standards to the unique characteristics of aircraft public water systems for the enhanced protection of public health against illnesses attributable to microbiological contamination. This is accomplished through multiple- barrier protection and procedural control measures. EPA believes that the combination of these components will better protect public health while building upon existing aircraft operations and maintenance programs, better coordinate federal programs that regulate aircraft water systems, and minimize disruption of aircraft flight schedules. DATES: Comments must be received on or before July 8, 2008. Under the Paperwork Reduction Act, comments on the information collection provisions must be received by OMB on or before May 9, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW- 2005-0025, by one of the following methods: http://www.regulations.gov: Follow the on-line instructions for submitting comments. E-mail: ow-docket@epa.gov. Mail: Water Docket, Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In addition, please mail a copy of your comments on the information collection provisions to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attn: Desk Officer for EPA, 725 17th St., NW., Washington, DC 20503. Hand Delivery: EPA Docket Center, Public Reading Room, EPA Headquarters West Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC 20460. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2005- 0025. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http:// www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an ``anonymous access'' system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through www.regulations.gov your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the docket are listed in the http:// www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the Water Docket, EPA/ DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Water Docket is (202) 566-2426. FOR FURTHER INFORMATION CONTACT: Richard Naylor, Drinking Water Protection Division, Office of Ground Water and Drinking Water (MC- 4606M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-3847; e-mail address: naylor.richard@epa.gov. For general information, contact the Safe Drinking Water Hotline, telephone number: (800) 426-4791. The Safe Drinking Water Hotline is open Monday through Friday, excluding legal holidays, from 10 a.m. to 4 p.m., Eastern time. SUPPLEMENTARY INFORMATION: I. General Information A. Does This Action Apply to Me? Entities potentially regulated by the proposed Aircraft Drinking Water Rule include air carriers that operate aircraft public water systems using finished surface water, finished ground water under the direct influence of surface water (GWUDI), or finished ground water. Regulated categories and entities include: ------------------------------------------------------------------------ Examples of regulated Category NAICS code entities ------------------------------------------------------------------------ Scheduled passenger air 481111 Air carriers. transportation. Nonscheduled chartered passenger 481211 Air carriers. air transportation. ------------------------------------------------------------------------ This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in this table could also be regulated. To determine whether your air carrier is regulated by this action, you should carefully examine the applicability criteria in section Sec. 141.800 of this proposed rule. If you [[Page 19321]] have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding section entitled FOR FURTHER INFORMATION CONTACT. B. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through http://www.regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for Preparing Your Comments. When submitting comments, remember to: Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number). Follow directions--The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes. Describe any assumptions and provide any technical information and/or data that you used. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. Provide specific examples to illustrate your concerns, and suggest alternatives. Explain your views as clearly as possible. Make sure to submit your comments by the comment period deadline identified. C. Abbreviations Used in This Notice ADWR: Aircraft Drinking Water Rule. ANSI: American National Standards Institute. AOC: Administrative Order on Consent. ATA: Air Transport Association. BMP: Best Management Practice. CDC: Centers for Disease Control and Prevention. CFR: Code of Federal Regulations. CRMP: Comprehensive Representative Monitoring Plan. CWS: Community Water System. DBP: Disinfection Byproducts. E. Coli: Escherichia coli. EO: Executive Order. EPA: United States Environmental Protection Agency. FAA: United States Federal Aviation Administration. FDA: United States Food and Drug Administration. FR: Federal Register. GWS: Ground Water System. GWUDI: Ground Water Under the Direct Influence of Surface Water. HACCP: Hazard Analysis and Critical Control Point. HHS: Department of Health and Human Services. HPC: Heterotrophic Plate Count. ICC: Interstate Carrier Conveyance. ICR: Information Collection Request. IESWTR: Interim Enhanced Surface Water Treatment Rule. LIMS: Laboratory Information Management System. mL: Milliliters. MCL: Maximum Contaminant Level. MCLG: Maximum Contaminant Level Goal. MDRL: Maximum Disinfectant Residual Level. mg/L: Milligrams per Liter. NASA: National Aeronautics and Space Administration. NCWS: Non-Community Water System. NDWAC: National Drinking Water Advisory Committee. NPDWR: National Primary Drinking Water Regulation. NSF: NSF International. NTNCWS: Non-Transient Non-Community Water System. NTTAA: National Technology Transfer and Advancement Act. PWS: Public Water System. OMB: Office of Management and Budget. QAPP: Quality Assurance Project Plan. RFA: Regulatory Flexibility Act. SAB: Science Advisory Board. SBA: Small Business Association. SDWA: Safe Drinking Water Act. SDWIS: Safe Drinking Water Information System. SWTR: Surface Water Treatment Rule. TC: Total Coliform. TCR: Total Coliform Rule. TNCWS: Transient Non-Community Water System. TT: Treatment Technique. UMRA: Unfunded Mandates Reform Act. WHO: World Health Organization. WSG: Water Supply Guidance. WSP: Water Safety Plan. D. Table of Contents I. General Information II. Background A. Legal Authority B. Purpose of the Proposed Rule C. Scope of Proposed Rule D. Potential Health Concerns Associated With Aircraft Water Systems E. Regulatory and Enforcement History III. Proposed Rule Development A. Stakeholder Involvement B. Data Collection Efforts C. Framework for Proposed Rule Development IV. Elements of the Proposed Aircraft Drinking Water Rule A. Sampling Requirements B. Responses to Sample Results C. Aircraft Water System Operation and Maintenance Plan D. Notification Requirements to Passengers and Crew E. Reporting Requirements F. Recordkeeping Requirements G. Audit and Self-Inspection Requirements H. Supplemental Treatment I. Violations J. Compliance Date V. Cost Analysis A. Summary of Regulatory Alternatives Considered B. National Cost Estimates C. Comparison of Cost of Regulatory Alternatives D. Estimated Impacts of Proposed Rule to Air Carrier Passengers E. Non-quantified Costs and Uncertainties VI. Relative Risk Analysis and Benefits A. Relative Risks--Qualitative Analysis B. Assessment of Potential Quantitative Relative Risk Analyses C. Non-quantified Benefits VII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Governments G. Executive Order 13045: Protection of Children from Environmental Health and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations or Low-Income Populations K. Consultations with the Science Advisory Board, National Drinking Water Advisory Council, and the Secretary of Health and Human Services L. Plain Language VIII. References II. Background A. Legal Authority EPA is proposing this regulation under the authority of the Safe Drinking Water Act (SDWA), as amended, 42 U.S.C. 300f et seq., primarily sections 1401, 1411, 1412 and 1450. Under SDWA, EPA establishes minimum requirements for tap water provided to the public, known as the National Primary Drinking Water Regulations or NPDWRs; these standards are applicable to ``public water systems.'' SDWA Section 1401 and EPA's regulations define a ``public water system'' (PWS) as a system for providing water for human consumption to the public through [[Page 19322]] pipes or other constructed conveyances and that regularly serves an average of a least twenty-five individuals daily, at least 60 days per year. 40 CFR 141.2. All public water systems are subject to the NPDWRs unless they are excluded from regulatory requirements under SDWA Section 1411. Section 1411 excludes from regulation any public water system that receives all its water from another regulated public water system, does not sell or treat the water, and is not a ``carrier which conveys passengers in interstate commerce.'' The classes of interstate carrier conveyances (ICCs) include aircraft, trains, buses, and water vessels. As a result, all ICCs that regularly serve water to an average of at least twenty- five individuals daily, at least 60 days per year are public water systems and are currently subject to existing NPDWRs regardless of whether they treat or sell the water. Due to the unique characteristics of aircraft water systems and demonstrated implementation challenges, EPA has decided that a new NPDWR specifically tailored to aircraft water systems is necessary and an Agency priority. EPA may decide to tailor existing requirements to other classes of ICCs in the future. B. Purpose of the Proposed Rule The primary purpose of the proposed Aircraft Drinking Water Rule (ADWR) is to ensure that safe and reliable drinking water is provided to aircraft passengers and crew. This entails providing air carriers with a feasible way to comply with SDWA and the NPDWRs. The existing NPDWRs were designed primarily with traditional, stationary public water systems in mind. Some of these requirements have proven difficult to implement when applied to aircraft water systems, which are operationally very different. For example, aircraft must maintain rigorous operating schedules. They fly to multiple destinations throughout the course of any given day and may board drinking water from sources at any of these destinations. Aircraft board water from airport watering points via temporary connections. Aircraft drinking water safety depends on a number of factors including the quality of the water that is boarded from these multiple sources, the care used to board the water, and the operation and maintenance of the onboard water system and the water transfer equipment (such as water cabinets, trucks, carts, and hoses). These unique operational characteristics present different challenges, which EPA is addressing in this proposal. EPA's NPDWRs establish different requirements based on the classification of the public water system (water system), including whether the system is a ``community,'' ``nontransient noncommunity,'' or ``transient noncommunity'' system and whether the system uses surface water or groundwater. Aircraft public water systems are considered transient noncommunity water systems (TNCWS), because they are not community water systems and they do not regularly serve at least 25 of the same persons over six months per year (See 40 CFR 141.2). Also, aircraft are regulated as surface water systems because they are likely to board finished drinking water from other public water systems that use surface water in whole or in part. EPA considers water for human consumption to include water for drinking and food preparation as well as water for brushing teeth and hand washing (see 63 FR 41941 (August 5, 1998)). Therefore, if an aircraft has a sink in the lavatory, then the water provided to that sink must be suitable for human consumption. C. Scope of Proposed Rule The proposed ADWR only addresses aircraft regulated under SDWA. SDWA does not regulate aircraft water systems operating outside the U.S.; however, EPA is supporting an international effort led by the World Health Organization (WHO) to develop international guidelines for aircraft drinking water. The proposed ADWR applies to the onboard water system only. EPA defers to the Food and Drug Administration (FDA) with respect to regulating watering points such as water cabinets, carts, trucks, and hoses from which aircraft board water. Aircraft that do not provide water for human consumption or those with water systems that do not regularly serve an average of at least twenty-five individuals daily at least 60 days out of the year do not meet the definition of a public water system; these aircraft are not regulated under the NPDWRs or covered under the new NPDWR proposed today. An estimated 63 air carriers and 7,327 aircraft public water systems are covered by this proposal. D. Potential Health Concerns Associated With Aircraft Water Systems The proposed ADWR assumes that only finished water is boarded on aircraft. Finished water means water that is introduced into the distribution system of a public water system and is intended for distribution and consumption without further treatment, except as necessary to maintain water quality in the distribution system (e.g., supplemental disinfection, addition of corrosion control chemicals) (40 CFR 141.2). The assumption that only finished water is boarded on aircraft is based on a FDA requirement that only potable water may be provided for drinking and culinary purposes on interstate carrier conveyances (ICCs) (21 CFR 1240.80). Aircraft public water systems that are boarding water that is not finished water will continue to be subject to existing NPDWRs and will not be subject to the new NPDWR proposed today. However, even when the water boarded is finished water, the opportunity exists for microbiological organisms to be introduced during the act of transferring the water from the supplier truck, cabinet, or cart to the aircraft water system, or for biofilm to develop within the water system itself. The proposed ADWR seeks to protect against disease-causing microbiological contaminants or pathogens through the required development and implementation of aircraft water system operation and maintenance plans that include best management practices, air carrier training requirements, and periodic sampling of the onboard drinking water. Testing drinking water for each individual pathogen is not practical, nor feasible. Instead, water quality and public health professionals use total coliform bacteria as an indicator organism. Total coliforms are a group of closely related, mostly harmless bacteria that live in soil and water as well as in the guts of animals. The presence of total coliforms in drinking water suggests that there may be disease-causing agents in the water or there has been a breach, failure, or other change in the integrity of the drinking water. Normally, total coliforms are not harmful to human health. However, if Escherichia coli (E. coli), a type of coliform bacteria, is present, it can be harmful to human health. Total coliforms are inactivated, or made harmless, by treatment or die off naturally in a manner similar to most bacterial organisms. However, if total coliforms are found in a water system, the system may be vulnerable to disease-causing bacteria (i.e., pathogens), whether pathogens are actually present or not. If an aircraft water system is not disinfected and/or flushed on a routine basis, it may be at risk for biofilm or other bacterial growth. Most of the bacteria in drinking water distribution systems are associated with biofilms. There are several studies showing that pathogenic organisms can survive longer and have greater resistance to chlorine when occurring in biofilms than in drinking water (Lehtola et al., 2007). Most aircraft water tanks [[Page 19323]] are either topped off or drained on a daily basis. However, there are occasional situations when the water may become stagnant. Some examples are aircraft that are occasionally taken out of service for an extended maintenance period, or cold weather conditions that affect the ability to drain tanks (due to concerns about the drained water freezing on the tarmac). Additionally, aircraft with water in their tanks that experience long layovers or overnight stays in high temperature areas have a higher potential for rapid growth of organisms. There are no data on outbreaks of illness caused by drinking water on aircraft. That does not mean there is no illness because there is a high rate of underreporting of illnesses caused by drinking water contamination. Illness resulting from consuming contaminated aircraft water would be no exception to this because the population onboard disperses after a flight and even if passengers develop gastrointestinal symptoms within hours of deplaning, they are unlikely to associate the illness with the aircraft water or to contact the air carrier or any government agency to report the illness. The effects of waterborne disease are usually acute, resulting from a single or small number of exposures. Most waterborne pathogens cause gastrointestinal illness with diarrhea, abdominal discomfort, nausea, vomiting, or other symptoms. Most such cases involve a sudden onset and generally are of short duration in healthy people. Some pathogens (e.g., Giardia and Cryptosporidium), however, may cause extended illness, lasting weeks or longer in otherwise healthy individuals. Waterborne pathogens are particularly harmful to sensitive populations, such as the immuno-compromised, and can sometimes prove fatal. E. Regulatory and Enforcement History SDWA, including the amendments of 1986 and 1996, require EPA to promulgate NPDWRs to prevent tap water contamination that may adversely affect human health. As TNCWSs, aircraft are subject to certain NPDWRs specific to this category of systems. EPA published Water Supply Guidance 29 (WSG 29) in October 1986 to assist ICC operators, including air carriers, in complying with these standards (USEPA 1986). WSG 29 described an alternative under which the operator of an ICC water system could use an approved operation and maintenance program in lieu of monitoring requirements. However, this guidance did not alter the regulatory requirements for ICCs. Since then, EPA has determined that a new rule specifically adapted to aircraft water systems would provide a clearer and more implementable regulatory framework for aircraft water systems. EPA suspended the earlier guidance in 2003 and is no longer approving operation and maintenance programs in lieu of monitoring under WSG 29 while the ICC program is being revised. In 2004, EPA found all aircraft water systems to be out of compliance with the NPDWRs. According to the air carriers, it is not feasible for them to comply with all of the monitoring that is required in the existing regulations. Subsequently, EPA tested 327 aircraft of which 15 percent tested positive for total coliform. In response to these findings, EPA embarked on a process to tailor the existing regulations for aircraft public water systems. In the interim, EPA placed 45 air carriers under Administrative Orders on Consent (AOC) that will remain in effect until tailored aircraft drinking water regulations are final. The air carrier AOCs combine sampling, best management practices, corrective action, public notification, and reporting and recordkeeping to ensure public health protection. Many drinking water rules for systems using surface water or ground water under the direct influence of surface water (GWUDI) relate to the treatment of source water, but because aircraft board finished water, the responsibility for treating the water is borne by the water supplier from which aircraft obtain their water. This situation is comparable to traditional, stationary water systems that are consecutive systems (i.e., buy finished water from other PWSs). The proposed ADWR adapts to aircraft water systems the applicable requirements from the Total Coliform Rule, the suite of surface water treatment regulations, and the Public Notification Rule, the relevant sections of which are summarized as follows. 1. The 1989 Total Coliform Rule The Total Coliform Rule (TCR) (USEPA, 1989) applies to all public water systems. Because monitoring water systems for every possible pathogenic organism is not feasible, coliform organisms are used as indicators of possible source water and distribution system contamination. Coliforms are easily detected in water and are used to indicate a water system's source and distribution system vulnerability to pathogens. In the TCR, EPA sets a Maximum Contaminant Level Goal (MCLG) of zero for total coliforms. EPA also sets a monthly Maximum Contaminant Level (MCL) for total coliforms and requires testing of total coliform-positive cultures for the presence of E. coli or fecal coliforms. E. coli and fecal coliforms indicate more immediate health risks from sewage or fecal contamination and are used as a trigger of acute contamination. In addition, the TCR requires sanitary surveys (i.e., onsite review of the water source, facilities, equipment, operation and maintenance of a PWS for the purpose of evaluating the adequacy of such source, facilities, equipment, operation and maintenance for producing and distributing safe drinking water). The TCR requires sanitary surveys by the State primacy agency every 5 years for systems that collect fewer than 5 total coliform samples per month (those serving 4,100 people or fewer). A TNCWS using surface water serving less than 1,000 persons daily would typically be required to take one total coliform sample per month for routine sampling requirements. 2. Surface Water Treatment Regulations EPA has promulgated a suite of regulations to address microbiological contamination of surface water. These regulations include the Surface Water Treatment Rule (SWTR), the Interim Enhanced Surface Water Treatment Rule (IESWTR), the Filter Backwash Recycling Rule, and the Long Term 1 and Long Term 2 Enhanced Surface Water Treatment Rules. These rules apply monitoring and treatment technique requirements to protect the public from microbiological pathogens in drinking water such as bacteria, viruses, Giardia lamblia, and Cryptosporidium. The monitoring and treatment technique requirements must be met prior to water entering the distribution system. Aircraft which board only finished water are not required to provide source water treatment or to perform monitoring of source water because these activities are the responsibility of the public water system from which the aircraft obtains finished water for boarding. However, the SWTR includes provisions for maintaining a detectable distribution system disinfectant residual and for monitoring distribution system disinfectant residuals at the same time and location as used for total coliform monitoring. Because disinfectant residual monitoring is required in the distribution system, current regulations require aircraft to perform this monitoring. A TNCWS using surface water serving less than 1,000 persons daily would typically be required to take one disinfectant residual sample per month. Additionally, the IESWTR requires primary enforcement agencies to conduct sanitary surveys for all [[Page 19324]] surface water and GWUDI systems regardless of size, and specifies a frequency of every 5 years for noncommunity water systems. 3. The Public Notification Rule Public water systems must give notice to persons served by the water system for violations of NPDWRs and for other situations posing a risk to public health from drinking water. The term ``NPDWR Violations'' is used in the public notification regulations to include violations of the MCL, Maximum Residual Disinfectant Level (MRDL), treatment technique (TT), monitoring, and testing procedure requirements. Public notice requirements are divided into three tiers, which take into account the seriousness of the violation or situation and of any potential adverse health effects that may be involved. Due to the transient nature of the public served by TNCWSs, public notice is typically provided through posting of the notice at locations where the public may access drinking water from the water system. 4. Roles of the FAA and FDA in Regulating Aircraft Drinking Water Drinking water safety on air carriers is jointly regulated by the EPA, the Food and Drug Administration (FDA), and the Federal Aviation Administration (FAA). EPA regulates the parent public water systems within the United States that supply water to the airports and the drinking water once it is onboard the aircraft. EPA is responsible for developing and implementing the NPDWRs for all public water systems, including public water systems on aircraft. FAA requires that air carrier companies submit operation and maintenance programs (14 CFR part 43, 14 CFR part 91, 14 CFR part 121) for all parts of the aircraft, including the water system. Under the current Memorandum of Understanding between EPA and FDA, the FDA takes the lead in regulating culinary water and the watering points where aircraft obtain water at the individual airports. FDA is responsible for approving all ICC watering points (21 CFR 1240.83(a)), (1) to ensure the water supply meets EPA's NPDWRs and (2) to ensure the methods (i.e., water transfer process) of and facilities (e.g., water cabinets, carts, trucks, containers, and hoses) for delivery of such water to the conveyance and the sanitary conditions surrounding such delivery prevent the introduction, transmission, or spread of communicable diseases. In addition to the EPA and FDA requirements, air carriers have many different on-going programs and practices for assessing and correcting deficiencies and risks associated with the drinking water supply and related safety, security and sanitation issues. Such programs and practices may include FAA Airworthiness Standards: Transport Category Airplanes (airworthiness maintenance and inspection program) (14 CFR part 43, 14 CFR part 91, and 14 CFR part 121); vulnerability assessments/security programs; FDA regulations for Interstate Conveyance Sanitation (USFDA 2005); FDA sanitary surveys of watering points and servicing areas; and FDA certification of aircraft sanitation systems including potable (finished) water, sewage, and galleys. These programs may contribute valuable information related to the condition of the aircraft water system and water quality. EPA has worked closely with FDA and FAA to ensure that this proposal for aircraft water system regulation is integrated with these programs to avoid unnecessary duplication. III. Proposed Rule Development A. Stakeholder Involvement In November 2004, when EPA announced that it had initiated a rulemaking process to develop regulations for aircraft public water systems, the Agency committed to working collaboratively with other federal agencies overseeing the air carrier industry, industry representatives, and interested stakeholders to identify appropriate requirements to ensure safe drinking water onboard aircraft. This collaborative rule development process has allowed EPA an opportunity to obtain information from, and hear the concerns and questions of stakeholders who would be affected by this rule in an organized and formal process prior to development of this proposed rule. EPA has held three public meetings; these were held in June 2005, January 2006, and March 2007. All three events were well-attended by stakeholders representing a diverse group of interests including: Air carriers, airports, flight attendants, pilots, passengers, public health officials, environmental groups, states, public water systems, water treatment and equipment vendors, laboratories, foreign government agencies, and other federal agencies (e.g., FDA, FAA, and CDC). EPA used a third-party skilled in conflict resolution to help facilitate the process and to involve the full range of interests. Given the number and complexity of issues associated with aircraft drinking water, EPA began with an assessment process to identify options to support and engage the full range of stakeholders in the regulatory development process. In June 2005, EPA held a public information meeting to kick-off the rulemaking process. The meeting was followed by the development of a stakeholder assessment report, produced by the third-party facilitator, which is available in the docket for this rule. This report included recommendations for a series of joint education workshops to bring diverse stakeholders together to identify and understand the issues and to provide input and comment on regulatory approaches and options. The first workshop was held on January 18-19, 2006. This workshop provided an opportunity for stakeholders to learn about aircraft water systems and watering points, current regulations, and other information relevant to the rulemaking. The stakeholders were encouraged to share their initial ideas about the issues that should be addressed in developing the proposed rule. EPA also presented for consideration by the stakeholders a conceptual approach for the rule, which draws on the principles of the Hazard Analysis and Critical Control Point (HACCP) and multiple barrier approaches. This systematic approach, known as the Water Safety Plan (WSP) approach, is described in greater detail in section III. C. Framework for Proposed Rule Development. The second workshop was conducted on March 28-29, 2007. At this workshop, EPA presented for comment examples of the application of the Water Safety Plan approach to aircraft water systems. Also, EPA presented the preliminary monitoring data collected under the air carrier Administrative Orders on Consent. The majority of the workshop time was spent soliciting stakeholder input on topics critical to the development of the ADWR including monitoring, best management practices, public and crew notification, reporting and recordkeeping requirements, and program oversight and verification. B. Data Collection Efforts In developing the ADWR proposal, EPA analyzed preliminary monitoring results submitted under the Administrative Orders on Consent (AOCs) from 2005-2007. In addition, to gain a better understanding of the drinking water quality on domestic aircraft as indicated by total coliform, E.coli/fecal coliform, and chlorine residual, EPA drew upon the results of the following three studies: (1) A [[Page 19325]] voluntary monitoring study completed by the Air Transport Association (ATA) in Fall 2003; (2) an EPA study of aircraft NPDWR compliance completed in 2004; and (3) the Canadian Inspection Program monitoring results completed in 2006 The EPA data summaries presented here should not be used to draw any definitive conclusions. The AOC dataset is incomplete and therefore considered preliminary since it represents 15 out of 45 domestic air carriers under AOCs with EPA. The 45 domestic air carriers were placed under AOCs to resolve non-compliance with the Safe Drinking Water Act and the National Primary Drinking Water Regulations. The AOCs established interim aircraft water testing and disinfection protocols. Each of the air carriers, at a minimum, was required to implement the following regular monitoring and disinfection protocols for its entire fleet: Regular monitoring of aircraft water systems for coliforms and disinfectant residuals; regular disinfection of aircraft water systems and water transfer equipment; corrective action for total coliform- positive sample(s); analysis of any total coliform-positive culture media for the presence of fecal coliforms or E. coli; provision of public notice or restriction of water service when there is a total coliform-positive sample result; performance of a study of possible sources of contamination that exist outside of the aircraft; and inclusion of information regarding various aspects of its domestic and foreign water practices. Specific to the AOC sampling data, air carriers were required to submit two documents for EPA approval that set the stage for monitoring and disinfection protocols/procedures: A Comprehensive Representative Monitoring Plan (CRMP) and a Quality Assurance Project Plan (QAPP). The CRMP describes the air carrier's sampling and disinfection processes and protocols for collecting samples within a 12-month period. The QAPP describes the air carrier's Quality Assurance/Quality Control processes to ensure good quality data and the methods for collecting and assessing data, such as use of State- or EPA-certified laboratories and EPA-approved analytical methods for analyzing drinking water samples. Once the plans were approved, air carriers were required to collect and submit their aircraft water system sampling data to EPA. As reflected in Table III-1, air carriers followed slightly different monitoring and disinfection protocols based on their fleet size. Table III-1.--Monitoring and Disinfection Protocols as Required Under the AOCs ------------------------------------------------------------------------ Air carriers Air carriers with greater with less than than 20 or equal to 20 aircraft aircraft ------------------------------------------------------------------------ MONITORING \1\ For each sample event, collect at [check] [check] least one sample from a galley and one from a lavatory for Total Coliform (TC) and Disinfectant Residual (total residual chlorine)... Sample 25% of fleet quarterly......... [check] ............... Sample all fleet quarterly............ ............... [check] DISINFECTING AND FLUSHING \2\ Disinfect and flush each aircraft's [check] [check] water system no less than quarterly.. Disinfect and flush watering points [check] [check] (e.g., water trucks, carts, cabinets, hoses) no less than monthly.......... ------------------------------------------------------------------------ \1\ The air carrier was required to use State- or EPA-certified laboratories and EPA-approved analytical methods for analyzing drinking water samples. \2\ If the air carrier has a pre-AOC monitoring and disinfecting program requiring a higher frequency, the air carrier was required to continue in accordance with their program, unless modification was requested and approved by EPA. As of May 31, 2007, of the 45 air carriers under AOCs, EPA has analyzed preliminary drinking water sampling data from 15 air carriers consisting of 2,316 aircraft out of an estimated total fleet size of 5,558. The total number of samples (routine and repeat) was 12,099. Of these samples, 3.1 percent (378 samples) were total coliform-positive. Of the 378 total coliform-positive samples, 2.4 percent (9 samples) were E. coli/fecal coliform-positive. Of a total of 7,489 routine chlorine residual samples taken, 26.1 percent (1,957) resulted in a non-detect. However, in relating the preliminary AOC sampling data to other aircraft water quality studies only the routine samples were used. Repeat samples were not used because they by nature have a higher probability of being total coliform-positive since repeats are taken after a routine sample is total coliform-positive. In addition, the other studies did not take repeat samples, therefore, the routine samples are most analogous to the data collected under the other studies. Therefore, in determining an estimated baseline of domestic air carrier drinking water quality the following was observed in the preliminary AOC data: Out of 7,812 routine samples, 2.8 percent (222 samples) were total coliform-positive. Of the 222 total coliform- positive samples, 2.3 percent (5 samples) were E. coli/fecal coliform- positive. Of the 3,952 routine chlorine residual samples taken, 21.5 percent (848) resulted in a non-detect. Under a voluntary study coordinated with EPA, ATA sampled 265 passenger aircraft operated by eight ATA-member U.S. air carriers. As noted by ATA, these eight air carriers represent the majority of the U.S. commercial passenger fleet, and serve both domestic and international routes. The aircraft were randomly selected and samples were generally collected from the galley, except in some cases where the galley faucets were equipped with filters, efforts were made to collect residual disinfectant samples from the lavatory. The samples were analyzed for total coliform (and in the case of a total coliform- positive result, the sample was tested for E. coli/fecal coliform), total residual chlorine, turbidity, total nitrate, and nitrite. Regarding microbiological testing, of the 265 aircraft sampled, 2.6 percent (7 aircraft) were total coliform-positive; there were no fecal coliform or E. coli-positive samples. Water samples from forty-one percent of the aircraft had non-detectable chlorine residuals (ATA 2003). In the 2004 EPA NPDWR Compliance study, 327 passenger aircraft belonging to ATA and non-ATA members were randomly tested at 12 U.S. airports that served both domestic and international routes. EPA analyzed the drinking water samples from galleys and lavatories for total coliform (and in the case of a total coliform-positive result, the sample was tested for E. coli/fecal coliform), total [[Page 19326]] residual chlorine, heterotrophic plate count, total nitrate, and nitrite. In regard to microbiological presence, 15 percent (49/327) of the aircraft tested positive for total coliform, and 4.1 percent (2/49 aircraft) of these total coliform positive aircraft also tested positive for E. coli/fecal coliform. Twenty-one percent (69/327) of the aircraft tested had a non-detectable chlorine residual. Under the Canadian Inspection Program, Health Canada randomly inspected 431 aircraft for microbiological presence in drinking water. Of the 431 aircraft tested, 15.1 percent (65 aircraft) were total coliform-positive, and 7.7 percent (5/65 aircraft) of these total coliform positive aircraft were also E. coli positive. Most of the contamination (4 samples) was found in water from the lavatory faucets. The Canadian study did not test for chlorine residual (Canada 2007a and 2007b). It is important to note that the intended purpose and use of the preliminary AOC and the other aircraft sampling results were to protect public health by providing an understanding of the quality of airline drinking water. Although they were not collected to drive the ADWR rulemaking process, these datasets provide important information for an estimated baseline of aircraft drinking water quality for total coliform, E. coli/fecal coliform, and residual chlorine. Although it is difficult to complete a one-to-one comparison of the sampling results among the studies, observed differences may be attributed to several factors. For instance, best management practices and protocols (such as systematic sampling, disinfecting, and flushing procedures) established under the AOCs may have played a part in the varying results. These systematic protocols may have created a greater chance of consistency and effectiveness among the air carriers in implementing the operational and maintenance procedures of an aircraft water system. In addition, these findings suggest that best management practices are important for public health protection. EPA will continue to collect and analyze the aircraft sampling data for the 45 air carriers under the AOCs. EPA will use the data to improve the Agency's understanding of aircraft drinking water quality relevant to microbiological controls. A summary of the final results will be released along with available sampling data from the 45 air carriers under AOCs. Docket ID No. EPA-HQ-OW-2005-0025. C. Framework for Proposed Rule Development For today's proposal, EPA has considered both the existing NPDWRs applicable to aircraft water systems--the Total Coliform Rule, the Surface Water Treatment Regulations and the Public Notification Rule-- and a systematic risk management approach used for food and water safety by other agencies, which EPA believes can be particularly effective when dealing with mobile sources of drinking water. The resulting proposed rule is intended to consolidate the three existing NPDWRs into one new NPDWR and modify them, based on the Water Safety Plan approach described as follows, so that the drinking water standards can be more effectively implemented for aircraft water systems and better integrated with FDA and FAA programs and requirements. 1. HACCP and Water Safety Plan Approaches EPA believes that an effective means of assuring safe drinking water onboard aircraft is through the application of a systematic risk management approach referred to as the Water Safety Plan (WSP) approach. The Water Safety Plan concept was developed by the World Health Organization (WHO) as part of the 3rd edition of its drinking water guidelines (WHO 2004). It is based on the Hazard Analysis and Critical Control Point (HACCP) concepts and the multiple barrier approach to protecting public health. The basic HACCP concepts were originally developed in 1959 by the Pillsbury Company with cooperation and participation from the National Aeronautics and Space Administration (NASA), the Natick Laboratories of the U.S. Army, and the U.S. Air Force Space Laboratory Project Group. The purpose was to ensure food and beverage safety from microbiological hazards for the first NASA manned space missions. Since the 1980s, the HACCP system has been adopted by food and beverage industries world- wide, where it forms an important part of their ``food safety plans.'' For example, the FDA has adopted the HACCP system as an effective approach for its food safety program. FDA utilized the HACCP approach in the final rules for the seafood and juice industries. HACCP guidelines developed by WHO, known as Codex Alimentarius, have been adopted internationally as the primary recognized food safety methodology for risk management. The current HACCP guideline (WHO, 1997) was developed by the Codex Alimentarius Commission. In the multiple barrier approach, technical and managerial barriers help prevent contamination at the source, treatment, distribution, and tap to provide a safe supply of drinking water for consumers. The barriers include risk prevention, risk management, monitoring and compliance, and individual action. As an enhancement of the HACCP approach, the Water Safety Plan approach identifies control measures not only at critical control points, as is done for HACCP, but also at the point of contamination where the hazardous event occurs as well as downstream of the potential contamination point. The intent is to enable the effect of the multiple barriers to be assessed together (Davison et al., 2005). The Water Safety Plan approach continues to evolve as the water industry gains experience by developing and implementing Water Safety Plans. 2. Proposed Rule Approach The proposed approach for this rulemaking effort includes elements of the HACCP approach and WHO's Water Safety Plan approach and builds on the foundation of the controls established under the existing NPDWRs applicable to aircraft water systems. This proposed regulation does not require each air carrier to develop its own Water Safety Plan (WSP). Instead, the WSP approach was used to outline the priority hazards and the control measures that could be implemented to control these hazards in the entire aircraft water supply and transfer chain. By looking holistically at the entire process, EPA ensured a collaborative working relationship with other federal agencies overseeing the air carrier industry. This holistic approach will minimize duplication of effort and regulation by multiple federal agencies over the same segment of the process. It also helps minimize concerns of over-regulation in one segment of a process to address an issue that could be more effectively handled in another segment of the process. Once the hazards and potential control measures were identified, EPA could then focus on the specific area of its jurisdiction, the onboard water system. 3. Identified Hazard Events and Potential Control Measures The following are examples of the primary hazard events and potential control measures for aircraft water systems identified through the WSP approach. Water to be boarded does not meet NPDWRs applicable to TNCWSs. The potential control measure is to prevent boarding of water, if operational needs (e.g., flushing of toilets) can be met [[Page 19327]] without boarding additional water. If water must be boarded, appropriate control measures are to: Restrict public access, provide public notification, including posting notices at lavatory and galley taps stating that the water is not for consumption; provide bottled water for coffee making and drinking; providing antiseptic alcohol- based hand gels or wipes for handwashing; disinfecting and flushing the aircraft water system as soon as possible; and demonstrating satisfactory aircraft water quality through follow-up sampling before resumption of unrestricted public access to the aircraft water system. Air carrier or aircraft crew is notified that water already boarded does not meet NPDWRs applicable to TNCWSs. The potential control measures are to: Restrict public access, provide public notification, including posting notices at lavatory and galley taps stating that the water is not for consumption; providing bottled water for coffee making and drinking; providing antiseptic alcohol- based hand gels or wipes for handwashing; disinfecting and flushing the aircraft water system as soon as possible; and demonstrating satisfactory aircraft water quality through follow-up sampling before resumption of unrestricted public access to the aircraft water system. Use of a watering point, including transfer and delivery systems, not approved by FDA. The potential control measure is for the air carrier to obtain approval from FDA for new watering points or when changing watering points. Contamination or cross contamination due to unsanitary practices. The potential control measures are to: Clean and disinfect hoses, transfer pumps, water trucks, and other equipment; develop written standard operating procedures (SOPs) and provide training for sanitary water transfer practices and aircraft cleaning; conduct total coliform monitoring; restrict public access, provide public notification, including posting notices at lavatory and galley taps stating that the water is not for consumption; providing bottled water for coffee making and drinking; providing antiseptic alcohol-based hand gels or wipes for handwashing; disinfecting and flushing the aircraft water system as soon as possible; and demonstrating satisfactory aircraft water quality through follow-up sampling before resumption of unrestricted public access to the aircraft water system; and conducting audits or inspections. Backflow from unprotected cross connection, failure of backflow prevention devices, or cross contamination from water line break. The potential control measures are to: Identify possible cross connections and install backflow prevention devices as warranted; repair failed backflow prevention devices; repair water line breaks; disinfect and flush the aircraft water system as soon as possible; and resample aircraft water quality before returning to service. Improperly designed aircraft water system. The potential control measure is to obtain FDA review and approval of plans and specifications (Certificate of Sanitary Construction) for new aircraft water systems. Bacterial growth in aircraft water system. The potential control measures are to: Conduct routine total coliform monitoring; and routinely disinfect and flush the aircraft water system. IV. Elements of the Proposed Aircraft Drinking Water Rule The following sections describe the elements of the aircraft drinking water rule as proposed by EPA. The proposed rule has significant operational advantages over the other more prescriptive alternatives, which are described in section V. EPA specifically designed the proposed rule to allow air carriers to follow the manufacturer recommendations for disinfecting and flushing aircraft water systems, instead of prescribing the frequency, chemical type and concentration to be used. Another advantage of the proposed rule over the approaches described in the alternatives is that by utilizing the manufacturer recommendations for disinfection and flushing, the rule requirements will automatically evolve (another stakeholder recommendation) with technological improvements in aircraft water tank lining and piping materials and as new more effective disinfectants are developed. EPA requests comment on all aspects of this rule. Please note, however, that EPA is not requesting, and will not consider, comments on any aspect of the TCR, surface water treatment regulations, Public Notification Rule or any other NPDWR other than as applied to aircraft water systems in this proposal. In addition to rule requirements, EPA identifies specific requests for comment on subject matters pertaining to the proposed rule. A. Sampling Requirements 1. Coliform Sampling Plan As discussed above, the existing TCR requires testing for total coliforms in water systems. Under this proposal, EPA is requiring each air carrier to develop a coliform sampling plan (within six months after the final rule is published in the Federal Register) for each aircraft that identifies the following: (1) Coliform sample collection procedures, (2) sample tap location(s) representative of the aircraft water system, including both galley and lavatory taps when available, (3) frequency and number of routine coliform samples to be collected (4) frequency of routine disinfection and flushing as specified in the operation and maintenance plan, and (5) procedures for communicating sample results promptly so that any required actions including repeat and follow-up sampling, corrective action, and notification of passengers and crew may be conducted in a timely manner. The development of a sampling plan will assist the air carrier in tracking regulatory requirements, identifying coliform detection trends, if any exist, and in maintaining compliance. 2. Coliform Sampling Requirements In keeping with the current TCR, air carriers need only determine the presence or absence of total coliforms in water samples collected from aircraft water systems; a determination of total coliform density would not be required. EPA believes this aids in making the sampling process more efficient and avoids unnecessary analysis. In addition, this proposed rule specifies that only analytical methodologies approved by EPA are to be used for sampling. For routine monitoring, each aircraft water system water sample must be 100 mL. One sample must be taken from a lavatory and one sample from a galley; each must be analyzed for total coliform. EPA believes the selection of sample taps from both the lavatory and the galley is necessary since tap options throughout these types of water systems is limited. If only one water tap is located in the aircraft water system due to aircraft model type and construction, then a single tap may be used to collect two separate 100 mL samples. Routine coliform sampling should be representative of the general conditions of the aircraft water system. To ensure that results of routine samples are not inadvertently skewed by sampling too soon after a disinfection event, routine coliform samples must not be collected within 72 hours after completing disinfection and flushing procedures. EPA believes that spacing routine samples evenly across monitoring periods will help. This is necessary in order to capture a representative sample from normal aircraft water system operations. Additional, or special, coliform sampling is always encouraged and recommended by EPA. [[Page 19328]] Routine coliform monitoring frequencies are as follows: If the air carrier disinfects and flushes the entire water system at least quarterly, then coliform monitoring must occur at least annually; If the air carrier disinfects and flushes the entire water system one to three times per year, then coliform monitoring must occur at least quarterly; or If the air carrier disinfects and flushes the entire water system less than once per year, then coliform monitoring must occur at least monthly. It should be noted that this is the first NPDWR that requires disinfection and flushing as a required extra barrier for the protection of public health. EPA understands that most of the air carrier maintenance programs employ water system disinfection and flushing; however, EPA believes that making three sampling frequency options available to air carriers for the aircraft water systems that they operate provides the flexibility to meet the evolving needs of the industry while still providing adequate barriers of protection. This proposal uses calendar-based monitoring and reporting frequencies. This basis is also consistent with EPA's current methods of oversight and is compatible with the Agency's current data systems. EPA is aware that the air carrier industry typically schedules maintenance or other activities based on aircraft flight hours or flight days. Scheduling activities on a calendar basis could lead to incompatibility and challenges in creating regular maintenance schedules. On the other hand, if an aircraft is not in frequent operation, basing aircraft water system activities on a flight time basis could lead to an extended calendar period before any actions are taken, which would not be protective of public health. EPA requests comment on whether the proposed calendar basis could reasonably be integrated with the air carrier industry's flight time basis, or if not, how the Agency should transpose the proposed requirements to an equivalent standard on a flight time basis. B. Response to Sampling Results 1. All routine coliform samples are negative. If all routine samples are total coliform-negative in a monitoring period, then the air carrier must continue to maintain its routine monitoring for coliform based on the frequency required under the rule. 2. The sample yields a positive result for total coliform. If any routine or repeat coliform sample is total coliform-positive, then that total coliform-positive culture medium must be analyzed to determine if fecal coliforms or E. coli are present. 3. One of two routine water samples test positive for total coliform, but negative for E. coli or fecal coliforms. In response to a single total coliform-positive sample result that is fecal/E. coli negative, the air carrier must perform at least one of the following: Disinfection and flushing no later than 72 hours after the laboratory notifies the air carrier of the positive result. Follow-up samples must be collected after disinfection and flushing is performed to ensure the effectiveness of the process. A complete set of post disinfection and flushing follow-up sample results (i.e., one from the lavatories and one from the galleys) must be total coliform-negative before the air carrier provides water from the aircraft water system to passengers and crew and returns to the routine monitoring frequency for coliform; or Repeat Sampling. Collect four 100 mL repeat samples within 24 hours of being notified of the positive result. Repeat samples must be collected and analyzed from four taps within the aircraft water system: the tap which resulted in the total coliform-positive sample, one other lavatory tap, one other galley tap, and one other tap; if less than four taps exist, then a total of four 100 mL samples must be collected and analyzed from the available taps within the aircraft water system. If no repeat sample is total coliform-positive, the system returns to its routine monitoring schedule and no further follow-up is required. 4. Any sample test result is fecal coliform positive or E. coli- positive. Since fecal coliform or E. coli bacteria indicate the potential presence of contaminants that can cause acute health risks, EPA believes it is necessary to take immediate corrective action for the protection of public health. The aircraft water system is not a traditional water system and the air carrier must therefore take additional measures to prevent any disease or illness. If any routine or repeat sample is fecal coliform-positive or E. coli-positive, then the air carrier must perform all of the following: Restrict public access to the aircraft water system which includes providing notification to passengers and crew as soon as possible but no later than 24 hours after being notified of the positive result. Conduct disinfection and flushing prior to resumption of unrestricted public access to the aircraft water system or no later than 72 hours if the aircraft water system cannot be physically disconnected/shut off to the crew and passengers. Collect follow-up samples after disinfection and flushing is performed to ensure the effectiveness of the process. A complete set of post disinfection and flushing follow-up sample results must be total coliform-negative before the air carrier provides water from the aircraft water system to passengers and crew and returns to the routine monitoring frequency for coliform. Follow-up sample procedures must, at a minimum, follow routine coliform sample locations and procedures. 5. More than one sample resulted in a total coliform-positive but was fecal coliform-negative or E. coli-negative. If more than one of any routine, repeat, or a combination of samples is total coliform positive and fecal coliform-negative or E. coli negative, then the air carrier must perform all of the following: Restrict public access to the aircraft water system which includes providing notification to passengers and crew as soon as possible but no later than 24 hours after being notified of the positive result. Conduct disinfection and flushing prior to resumption of unrestricted public access to the aircraft water system, or no later than 72 hours if the aircraft water system cannot be physically disconnected/shut off to the crew and passengers. Collect follow-up samples after disinfection and flushing is performed to ensure the effectiveness of the process. A complete set of post disinfection and flushing follow-up sample results must be total coliform-negative before the air carrier provides water from the aircraft water system to passengers and crew and returns to the routine monitoring frequency for coliform. Follow-up sample procedures must, at a minimum, follow routine coliform sample locations and procedures. 6. Post disinfection and flushing follow-up sampling. Follow-up samples are necessary to validate the effectiveness of the disinfection and flushing procedures. If one or more of the follow-up samples in a set of follow-up samples is total coliform-positive then, as a minimum, the air carrier must disinfect and flush again, then take a new set of follow-up samples. Both follow-up sample results must be total coliform-negative before the aircraft water system provides water to passengers and crew and the air carrier returns to the routine monitoring frequency for coliform. [[Page 19329]] 7. Failure to conduct routine coliform monitoring or analysis, or boarding water from a watering point not approved by the FDA. If there was a failure to collect and analyze the required number of routine coliform samples, or water was boarded in the United States from a watering point not approved by the FDA, or outside the United States in a manner not in accordance with the air carrier's procedures for ensuring the w