## Form for Compliance with E.O. 12866 Docket Requirements

Title of Regulation: National Primary Drinki ng Water Regulations: Revisions to the Total Coliform Rule Contact person: Sean Conley
Phone number: 202-564-1781

Was this regulation reviewed by OMB under Executive Order 12866 - Regulatory Planning and Review ? ( 9 ) Yes ( ) No If you checked “no”, you are done with this fo rm. Simply place it in the docket for your regulation. If you checked “yes”, please fill out the remainder of the form before placing it in the docket. Also docket any relevant documents referenced in the form.

For regulations that are checked “Yes” above: This regulation was reviewed by OMB under Executive Order 12866 - Regulatory Planning and Review

. Attached is the draft regulation and any other documents sent to OMB for review, such as analyses and assessments. E.O. 12866 requires agencies to make these publicly available. E.O. 12866 also requires agencies to identify the substantive changes between the draft regulation sent to OMB for review and the regulation subsequently announced [ Please check the appropriate box below: ] EPA made substantive changes to this regulation (includes changes initiated by EPA or OMB). Attached is a document which: (1) identifie s all the substantive changes made, and (2) notes those changes OMB s uggested or recommended.
9 No substantive changes were made to this regulation Therefore, no further attachments are required. If you have questions about this regulation, please call the EP A contact person listed above.

Revised January 2009Document initiating EO 12866 review

1 ENVIRONMENTAL PR OTECTION AGENCY
40 CFR Parts 141 and 142 [EPA-HQ-OW-2008-0878; FRL- ]
RIN 2040-AD94 National Primary Drinking Water Regulation s: Revisions to the Total Coliform Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.

SUMMARY: The Environmental Protection Agency (EPA or the Agency) is proposing revisions to the 1989 Total Coliform Rule. The proposed Revised Total Coliform Rule offers a meaningful opportunity for great er public health protection beyond the current Total Coliform Rule. The proposed revisions require systems that have an indication of coliform contamination in the distribution system to assess the problem and take corrective action that may reduce cases of illnesses and deaths due to potential fecal co ntamination and waterborne pathogen exposure. EPA is also proposing to revise portions of the Ground Water Rule triggered source monitoring requirements as a result of the proposed Revised To tal Coliform Rule repeat sample requirement. These proposed revisions are in accordance with the Safe Drinking Water Act as amended, which requires EPA to review and revise, as appropriate, each national primary drinking water regulation promulgated under the Safe Drinking Wate r Act not less often than every six years. As with the current Total Coliform Rule, the propos ed Revised Total Coliform Rule applies to all public water systems.
DATES: Comments must be received on or before [INSERT DATE 60 DAYS AFTER DATE
OF PUBLICATION IN THE FEDERAL REGISTER ]

.Document initiating EO 12866 review

2 ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-2008-0878, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• E-mail: OW-Docket@epa.gov , Attention Docket ID No. EPA-HQ-OW-2008-0878

• Mail: Water Docket, Environmental Protection Agency, Mailcode: 4101T, 1200 Pennsylvania Ave., NW, Washington, DC 20460, Attention Docket ID No. EPA-HQOW-2008-0878. In addition, please mail a copy of your comments on the information collection provisions to the Office of Info rmation 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 , (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. Such deliveries are only accepted during the Docket’s normal hours of operation, and sp ecial arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2008-0878. 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 informa tion claimed to be Confidential Business Information (CBI) or other information whose disclo sure is restricted by st atute. 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 website is an “anonymous access” system, which means EPA will not know your identity or contactDocument initiating EO 12866 review

3 information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through http://www.regulations.gov , your email 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 informa tion in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot r ead your comment due to technical difficulties and cannot contact you for clarification, EPA ma y not be able to consider your comment. Electronic files should avoid the us e of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EP A’s public docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm

. Docket: All documents in the doc ket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is re stricted by statue. Ce rtain 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 Docket Center, EPA/ DC, EPA West, Room B102, 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 ho lidays. 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: Sean Conley, Standards and Risk Management Division, Of fice of Ground Water and Dr inking Water (MC-4607M), Environmental Protection Agency, 1200 Penns ylvania Ave., NW, Washington, DC 20460; telephone number: (202) 564-1781; e-mail address: conley.sean@epa.gov . For generalDocument initiating EO 12866 review

4 information, contact the Safe Drinking Water Ho tline, telephone number: (800) 426-4791. The Safe Drinking Water Hotline is open Monday thr ough Friday, excluding legal holidays, from 10 a.m. to 4 p.m. Eastern time.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Regulated Categories and Entities Entities potentially regulated by the proposed Revised Total Co liform Rule (RTCR) are all public water systems (PWSs). Regulated cat egories and entities include the following:
Category Examples of regulated entities Industry Privately-owned community water systems (CWSs), transient non-community watersystems (TNCWSs), and non-transient noncommunity water systems (NTNCWSs). State, Tribal, and local government s Publicly-owned CWSs, TNCWSs, and NTNCWSs. This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by th is action. Other types of entitie s not listed in the table could also be regulated. To determine whether your facility is regulated by this action, you should carefully examine the definiti on of “public water system” in §141.2 and the section entitled “Coverage” in §141.3 in title 40 of the Code of Federal Regulations (CFR), and th e applicability criteria in §141.850(b) of this propo sed rule. If you have questions regarding the applicability of this action to a particular entity, co nsult the person listed in the preceding “ FOR FURTHER
INFORMATION CONTACT ” section.
B. Copies of This Document and Other Related InformationDocument initiating EO 12866 review

5 This document is available for download at http://www.epa.gov/safewat er/disinfection/tcr/

. For other related information, see preceding discussion on docket.
Abbreviations Used in This Document ADWR Airline Drinking Water Rule AGI Acute Gastrointestinal Illness AIDS Acquired Immune Deficiency Syndrome AIP Agreement in Principle AWWA American Water Works Association ATP Alternative Test Procedure AWOP Area Wide Optimization Program BAT Best Available Technology C Celsius CA Corrective Action CBI Confidential Business Information CCR Consumer Confidence Report CDC Centers for Disease Control and Prevention CFR Code of Federal Regulations COI Cost of Illness CWS Community Water System DBPs Disinfection Byproducts DWC Drinking Water Committee EA Economic Analysis EC E. coli EC-MUG EC Medium with MUG EPA United States Environmental Protection Agency ETV Environmental Technology Verification FR Federal Register GW Ground Water GWR Ground Water Rule GWS Ground Water System GWUDI Ground Water Under the Direct Influence of Surface Water HRRCA Health Risk Reduction and Cost Analysis HUS Hemolytic Uremic Syndrome ICR Information Collection Request IESWTR Interim Enhanced Surface Water Treatment Rule M Million MCL Maximum Contaminant Level MCLG Maximum Contaminant Level Goal mg/L Milligrams per Liter ml Milliliters MOU Memorandum of Understanding MRDL Maximum Residual Disinfectant Level MUG 4-methylumbelliferyl-Beta-D-glucuronideDocument initiating EO 12866 review

6 NCWS Non-community Water System NDWAC National Drinking Water Advisory Council NPDWR National Primary Drinking Water Regulation NTNCWS Non-Transient Non-Community Water System NTU Nephelometric Turbidity Unit OMB Office of Management and Budget PN Public Notification PWS Public Water System RFA Regulatory Flexibility Act RICP Research and Information Collection Partnership RTCR Revised Total Coliform Rule SAB Science Advisory Board SBA Small Business Administration SDWA Safe Drinking Water Act SDWIS Safe Drinking Water Information System SDWIS/FED Safe Drinking Water In formation System Federal Version SOP Standard Operating Procedure Stage 1 DBPR Stage 1 Disinfectants and Disinfection Byproducts Rule Stage 2 DBPR Stage 2 Disinfectants and Disinfection Byproducts Rule SW Surface Water SWTR Surface Water Treatment Rule TC Total Coliforms TCR Total Coliform Rule TCRDSAC Total Coliform Rule / Distribution System Advisory Committee TNCWS Transient Non-Community Water System T&C Technology and Cost US United States UV Ultraviolet Radiation WRF Water Research Foundation
TABLE OF CONTENTS
I. General Information A. Regulated Categories and Entities B. Copies of This Document and Other Related Information II. Background A. Statutory Authority B. Total Coliform Rule Distribution Sy stem Advisory Committee (TCRDSAC) C. Other Outreach Processes D. Public Health Concerns Addressed by the Proposed Revised Total Coliform Rule 1. Public health concerns, fecal cont amination, and waterborne pathogens 2. Indicators 3. Occurrence of fecal contamination and waterborne pathogens III. Proposed Revised Total Coliform Rule A. Proposed Rule Provisions and Rationale 1. Terms used in the proposed RTCRDocument initiating EO 12866 review

7 2. MCLG and MCL for E. coli , and coliform treatment technique 3. Monitoring 4. Repeat samples 5. Treatment technique requirements 6. Violations 7. Providing notification and information to the public 8. Reporting and recordkeeping requirements for systems 9. Analytical methods B. Proposed Compliance Date C. Links to Other Drinking Water Rule Requirements 1. SWTR, Stage 1 and Stage 2 DBPRs, ADWR 2. GWR 3. Sanitary surveys D. Best Available Technology (BAT) 1. Provisions 2. EPA’s rationale 3. Request for comment E. Variances and Exemptions 1. Provisions 2. EPA’s rationale 3. Request for comment F. Request for Comment on Other Issues Related to the Proposed RTCR 1. Consistency between the proposed RTCR and the GWR 2. Storage tank insp ection and cleaning 3. States under EPA direct implementation G. Limitations to the Public Comment on the Proposed RTCR IV. State Implementation A. State Special Primacy Requirements B. State Recordkeeping Requirements C. State Reporting Requirements D. Interim Primacy E. Request for Comment V. Distribution System Research and Information Collection Activities A. Research and Information Collection Partnership B. Distribution System Optimization Activities C. Request for Comment VI. Economic Analysis (Health Risk Reduction and Cost Analysis) A. Regulatory Options Considered B. Major Sources of Data and Information used in Supporting Analyses 1. Safe Drinking Water Information System Federal Version data 2. Six-Year Review 2 data 3. Other information sources C. Occurrence and Pred ictive Modeling 1. Model used for public water systems serving 4,100 or fewer people 2. Model used for public water systems serving more than 4,100 people D. Baseline ProfilesDocument initiating EO 12866 review

8 E. Anticipated Benefits of the Proposed RTCR 1. Relative risk analysis 2. Changes in violation rate s and corrective actions 3. Nonquantifiable benefits F. Anticipated Costs of the Proposed RTCR 1. Total annualized present value costs 2. PWS costs 3. State costs 4. Nonquantifiable costs G. Potential Impact of the Proposed RTCR on Households H. Incremental Costs and Benefits I. Benefits from Simultaneous Reduction of Co-occurring Contaminants J. Change in Risk from Other Contaminants K. Effects of Fecal Contamination and/or Waterborne Pathogens on the General Population and Sensitive Subpopulations 1. Risk to children, pregna nt women, and the elderly 2. Risk to immunocompromised persons L. Uncertainties in the Benefit and Cost Estimates for the Proposed RTCR 1. Inputs and their uncertainties 2. Sensitivity analysis M. Benefit Cost Determination for the Proposed RTCR N. Request for Comment VII. Statutory and Executive Order Review A. Executive Order 12866: Regulat ory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act (RFA) D. Unfunded Mandates Reform Act (UMRA) E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordi nation with Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions That Significantl y Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancem ent Act J. Executive Order 12898: Federal Actions to A ddress Environmental Justice in Minority Populations and Low-Income Populations K. Consultations with the Science Advisory Bo ard, National Drinking Water Advisory Council, and the Secretary of Health and Human Services L. Impacts on Sensitive Subpopulations as Requi red by Section 1412(b)(3 )(C)(i) of the 1996 Amendments of the Safe Drinking Water Act (SDWA) M. Plain Language VIII. References
II. Background
A. Statutory AuthorityDocument initiating EO 12866 review

9 The Safe Drinking Water Act (SDWA) requires th e EPA to review and revise, as appropriate, each existing national primary drinking water regu lation (NPDWR) at least once every six years (SDWA section 1412(b)(9), 42 U.S.C. 300g-1(b)(9)). In 2003, EPA complete d its review of the Total Coliform Rule (TCR) and 68 NPDWRs for ch emicals that were promulgated prior to 1997 (USEPA 2003, 68 FR 42908, July 18, 2003)
. The purpose of the review was to identify new health risk assessments, changes in technology, a nd other factors that would provide a healthrelated or technological basis to support a regulatory revision th at would maintain or improve public health protection. In the Six-Year Review 1 determination published in July 2003 (USEPA 2003, 68 FR 42908, July 18, 2003), EPA stat ed its intent to revise the 1989 TCR (also referred to as the “current TCR”)..
B. Total Coliform Rule Distribution Sy stem Advisory Committee (TCRDSAC) In June 2007, EPA established the Total Co liform Rule/Distribution System Advisory Committee (“TCRDSAC” or “the advisory committee”) in accordance with the provisions of the Federal Advisory Committee Act, 5 U.S.C. App. 2, 9 (c), to provide recommendations to EPA on revisions to the 1989 TCR and on what information a bout distribution system issues is needed to better understand and address possible public hea lth impacts from poten tial degradation of drinking water distribution systems (USEPA 2007a, 72 FR 35869, June 29, 2007). The decision to include a review of distribu tion system issues was made, in part, to address recommendations made by the Stage 2 Microbial and Disinfecti on Byproducts Federal Advisory Committee in December 2000 (USEPA 2000b, 65 FR 83015, Decem ber 29, 2000). The TCRDSAC used available information to analyze options for revisions to the TCR. The TCRDSAC also considered research and information needed to better understand and addr ess public health risks from contamination of distribution systems.Document initiating EO 12866 review

10 The advisory committee consisted of representa tives of EPA, State a nd local public health and regulatory agencies, consumer organizations , environmental organi zations, local elected officials, Indian Tribes, and drinking water suppliers. A technical workgroup was also formed to provide the advisory committee wi th necessary technical support a nd analysis to facilitate the committee’s discussions. The advisory committee met on 13 occasions between July 2007 and September 2008. All advisory committee members agreed to and signed the final Agreement in Principle (AIP) in September 2008. All of the recommendations of the advisory committee are found in the signed AIP. Pursuant to the AIP, EPA agreed to pr opose revisions to the TCR that, to the maximum extent consistent with EPA’s legal obligations, have the same substance and effect as the elements of the AIP. Each part y represented on the advisory committee agreed in the AIP not to take any action to inhibit the adoption and implementation of final rule(s) to the extent it and the corresponding preamble have the same substance and effect as the elements of the AIP. EPA also agreed in the AIP to develop a Research and Information Collection Partnership (RICP) to “inform and support the drinking water community in developing future national risk management decisions pertaini ng to drinking water di stribution systems” by providing “a formal process for systema tic planning, implementation, analysis, and communication of distribution system research and information collectio n” (USEPA 2008c). A discussion of the RICP can be found in section V of this preamble. The AIP and details about the advisory committee can be found at EPA’s website at: http://www.epa.gov/safewater/disinfec tion/tcr/regulati on_revisions.html

. In addition to the outreach mentioned above , EPA agreed to engage in various future stakeholder meetings at least annually, to wh ich all advisory committee members and the public at large would be invited. In April 2009, EP A held its first annual stakeholder meeting toDocument initiating EO 12866 review

11 provide draft proposed regulation updates and an opportunity for stakeholders to provide feedback on the development of the proposed RTCR.
C. Other Outreach Processes In addition to consulting with the adviso ry committee, EPA engaged in several other activities as part of the Agency ’s outreach to stakeholders in developing the proposed RTCR. EPA held a technical workshop in Washington, DC, from January 30 to February 1, 2007, to discuss available information on the current TCR and available informati on regarding risks in distribution systems in support of revisions to the TCR. Other EPA outreach activities, namely the National Drinking Water Advisory Counc il consultation, Science Advisory Board consultation, and the Tribal consultation, are di scussed in section VII of this preamble.
D. Public Health Concerns Addressed by the Proposed Revised Total Coliform Rule
1. Public health concerns, fecal cont amination, and waterborne pathogens The proposed RTCR aims to increase public health protection th rough the reduction of potential pathways of entry for fecal contaminat ion into the distribution system. Since these potential pathways represent vulnerabilities in the distribution system whereby fecal contamination and/or waterborne pathogens, incl uding bacteria, viruses a nd parasitic protozoa could possibly enter the system, the reduction of these pathways in general should lead to reduced exposure and associated risk from these contaminants. Fecal contamination and waterborne pathogens can cause a variety of illne sses, including acute gastrointestinal illness (AGI) with diarrhea, abdomina l discomfort, nausea, vomiting, a nd other symptoms. Most AGI cases are of short duration and result in mild illness. Other more severe illnesses caused by waterborne pathogens include he molytic uremic syndrome (HUS) (k idney failure), hepatitis, and bloody diarrhea (WHO 2004). Chronic disease su ch as irritable bowel syndrome, reducedDocument initiating EO 12866 review

12 kidney function, hypertension and reactive arthritis can result from infection by a waterborne agent (Clark et al . 2008). When humans are exposed to and infected by waterborne en teric pathogens, the pathogens become capable of reproducing in the gastrointestinal tract. As a result, healthy humans shed pathogens in their feces for a period ranging from days to weeks. This shedding of pathogens often occurs in the abse nce of any signs of clinical illness. Regardless of whether a pathogen causes clinical illness in the person who sheds it in his or her feces, the pathogen being shed may infect other people directly by person-to-person spread, contact with contaminated surfaces, and other means which are referred to as secondary sp read. As a result, waterborne pathogens that are initially waterborne may subs equently infect other people through a variety of routes (WHO 2004). Sensitive subpopulations are at greater risk from waterborne disease than the general population (Gerba et al. 1996). For a discussion of sensitive subpopulations, see section VII.L of this preamble.
2. Indicators Total coliforms are a group of closely related bacteria that, with few exceptions, are not harmful to humans. Coliforms are abundant in th e feces of warm-blooded animals, but can also be found in aquatic environments, in soil, a nd on vegetation. Colif orm bacteria may be transported to surface water by run-off or to gr ound water by infiltration. Total coliforms are common in ambient water and may be injured by environmental stresses such as lack of nutrients, and water treatments such as chlori ne disinfection, in a manner similar to most bacterial pathogens and many viral enteric pa thogens (including fecal pathogens). EPA considers total coliforms to be a useful indicator that a potenti al pathway exists through which fecal contamination can enter the distribution syst em. The absence (versus the presence) of totalDocument initiating EO 12866 review

13 coliforms in the distribution system indicates a reduced likelihood that fecal contamination and/or waterborne pathogens are oc curring in the distribution system. Under the current TCR, each total coliform-pos itive sample is assayed for either fecal coliforms or E. coli . Fecal coliform bacteria are a subgr oup of total coliforms that traditionally have been associated with fecal contaminati on. Since the promulgation of the TCR, more information and understanding of the su itability of fecal coliform and E. coli as indicators have become available. Study has shown that the fecal coliform assay is imprecise and too often captures bacteria that do not originat e in the human or mammal gut (Edberg et al . 2000). On the other hand, E. coli is a more restricted group of coliform b acteria that almost always originate in the human or animal gut (Edberg et al. 2000). Thus, E. coli is a better in dicator of fecal contamination than fecal coliforms.
3. Occurrence of fecal contamination and waterborne pathogens

a. Presence of fecal contamination. Fecal contamination is a very general term that includes all of the organism s found in feces, both pathogenic and nonpathogenic. Fecal contamination can occur in drinking water both through use of contaminated source water as well as direct intrusion of fecal contamination into the drinking water distribution system. Lieberman et al . (1994) discuss the general associat ion between fecal contamination and waterborne pathogens. Biofilm s in distribution systems may harbor waterborne bacterial pathogens and accumulate enteric viruses and parasitic protozoa (Skraber et al . 2005; Helmi et al. 2008). Waterborne pathogens in biofilms may have entered the distribution system as fecal contamination from humans or animals. Co-occurrence of indicators and waterborne pathogens is difficult to measure. The analytical methods approved by EPA to assay for E. coli are able to detect indicators of fecalDocument initiating EO 12866 review

14 contamination. They do not specifica lly identify most of the pathogenic E. coli strains. There are at least 700 recognized E. coli strains (Kaper et al. 2004). About 10 per cent of recognized E. coli strains are pathogenic to human s (Feng 1995; Hussein 2007; Kaper et al. 2004). Pathogenic
E. coli include E. coli O157:H7, which is the primary cause of hemolytic uremic syndrome (HUS) in the United States (Rangel et al. 2005). The US Centers for Disease Control and Prevention (CDC) estimates that there are 73,000 cases of illness each year in the US due to E. coli O157:H7 (Mead et al. 1999). The CDC estimates that a bout 15 percent of all reported E. coli O157:H7 cases are due to water contamination (Rangel et al. 2005). Active surveillance by CDC shows that 6.3 percent of E. coli O157:H7 cases progress to HUS (Griffin and Tauxe 1991; Gould et al. 2009) and about 12 percent of HUS cases re sult in death within four years (Garg et al. 2003). About 4 to 15 percent of cases ar e transmitted within households by secondary transmission (Parry and Salmon 1998). Because EPA-approved standard methods for E. coli do not typically identify the presence of the pathogenic E. coli strains, an E. coli -positive monitoring result is an indicator of fecal contamination but is not necessari ly a measure of waterborne pa thogen occurrence. Specialized assays and methods are used to identify waterborne pathogens, including pathogenic E. coli

. One notable exception is the data reported by Cooley et al . (2007), which showed high concentrations of pathogenic E. coli strains in samples containing high concentrations of fecal indicator E. coli . These data are from streams and ot her poor quality surface waters surrounding California spinach fields associated with the 2006 E. coli O157:H7 foodborne outbreak. Data equivalent to these samples are not available from drinking water samples collected under the
TCR.Document initiating EO 12866 review

15 Because E. coli is an indicator of fecal contamination (Edberg et al . 2000), and because of the general association between fecal contamination and waterborne pathogens (Lieberman et al

. 1994; Lieberman et al . 2002), E. coli is a meaningful indicator fo r fecal contamination and the potential presence of associated pathogen occurrence.
b. Waterborne disease outbreaks. The CDC defines a waterb orne disease outbreak as occurring when at least two persons (or one with amoebic meningoencephalitis) experience a similar illness after ingesting a specific drinking wate r (or after exposure to recreational water) contaminated with pathogens (or chemicals) (Kramer et al . 1996). The CDC maintains a database on waterborne disease outbreaks in the United States . The database is based upon responses to a voluntary and confid ential survey form that is co mpleted by State and local public health officials. The National Research Council strongly suggests that the number of identified and reported outbreaks in the CDC database for surface and ground waters represents only a small percentage of actual number of waterborne disease outbreaks (NRC 1997; Bennett et al . 1987; Hopkins et. al . 1985 for Colorado data). Under-reporting occu rs because most waterborne outbreaks in community water systems are not recognized un til a sizable proportion of the population is ill (Perz et al . 1998; Craun 1996), perhaps 1 percent to 2 percent of the popul ation (Craun 1996). EPA drinking water regulations are designed to protect agains t endemic waterborne disease and to minimize waterborne outbreaks. In contrast to epidemic, endemic refers to the persistent low to moderate level or the unusual ongoing oc currence of illness in a given population or geographic area (Craun et al. 2006).
III. Proposed Revised Total Coliform RuleDocument initiating EO 12866 review

16 The proposed RTCR maintains and strengthens the objectives of the current TCR and is consistent with the recommendations in the AIP. The objectives are: (1) to evaluate the effectiveness of treatment, (2) to determine the integrity of the distribution system, and (3) to signal the possible presence of fecal contaminati on. The proposed revision better addresses these objectives by requiring systems that may be vulnerable to fecal contamination (as indicated by their monitoring results) to do an assessment, to identify whether any sanitary defect(s) is (are) present, and to correct the def ects. Therefore, the Agency anticipates greater public health protection under the proposed RTCR compared to the current TCR because of its more preventive approach to identifying and fixing probl ems that affect or may affect public health. The following is an overview of the ke y provisions of the proposed RTCR:

• MCLG and MCL for E. coli and coli form treatment technique fo r protection against potential fecal contamination . The proposed RTCR establishes a maximum contaminant level goal (MCLG) and maximum contaminant level (MCL) for E. coli. It takes a preventive approach to protecting public health by esta blishing a coliform treatment t echnique for protection against potential fecal contamination. The treatment technique us es both total coliforms and E. coli monitoring results to start an evaluation proce ss that, where necessary, will require the PWS to conduct follow-up corrective action that could prevent future incidences of contamination and exposure to fecal contamination and/or waterbor ne pathogens. See section III.A.2 of this preamble for a detailed discussion on the MCLG , MCL, and treatment technique requirements.

• Monitoring . As with the current TCR, PWSs will c ontinue to monitor for total coliforms and
E. coli according to a sample siting plan a nd schedule specific to the system. Sample siting plans under the proposed RTCR must continue to be representative of the water throughout the distribution system. Under the proposed RTCR, systems have theDocument initiating EO 12866 review

17 flexibility to propose repeat sample locations th at best verify and determine the extent of potential contamination of the di stribution system rather than having to sample within five connections upstream and downstrea m of the total coliform-positive sample location. In lieu of proposing new repeat sample locations, the system s may stay with the de fault used under the current TCR of five connections upstream and down stream of the total coliform-positive sample location. As with the current TCR, the proposed RTCR allows reduced monitoring for some small ground water systems. The proposed RTCR is e xpected to improve public health protection compared to the current TCR by requiring small ground water systems that are on or wish to conduct reduced monitoring to meet certain eligibility criteria. Examples of the criteria include a sanitary survey showing that the system is fr ee of sanitary defects, a clean TCR compliance history for 12 months, and a recurring annual s ite visit by the State an d/or a voluntary Level 2 assessment for systems on annual monitoring For small ground water systems, the proposed RTCR requires increased monitoring for high-risk systems that meet certain criteria such as unacceptable compliance history under the RTCR. The proposed RTCR specifies conditions under which systems will no longer be eligible for reduced monitoring and be requ ired to return to routine m onitoring or to monitor at an increased frequency. The proposed RTCR requires systems on a quarterly or annual monitoring frequency (applicable only to ground water systems serv ing 1,000 or fewer people) to conduct additional routine monitoring the month following one or mo re total coliform-positive samples. Under the proposed RTCR, systems must collect at least three routine samples during the next month, unless the State waives the additional routine mo nitoring. This is a re duction in the requiredDocument initiating EO 12866 review

18 number of additional routine samples from the cu rrent TCR, which requires at least five routine samples in the month following a total coliform-positive sample for all systems serving 4,100 or fewer people. The current TCR requires all systems serving 1,0 00 or fewer people to co llect at least four repeat samples while PWSs serving 1,000 people or greater to collect three repeat samples. The proposed rule requires three repeat samples af ter a routine total coliform-positive sample, regardless of the system type and size. See sections III.A.3 and III.A.4 of this pream ble for detailed discussions of the routine monitoring and repeat sampling re quirements of the proposed RTCR.

• Seasonal systems . The proposed RTCR establishes monitoring requirements for seasonal systems for the first time. Seasonal systems represent a special case in that the shutdown and start-up of these water systems present additio nal opportunities for contamination to enter or spread through the distribution system. Seas onal systems must demonstrate completion of a State-approved start-up procedur e. In addition, they must de signate the time period(s) for monitoring based on site-specific considerations (such as during periods of highest demand or highest vulnerability to contamination) in their State-approved sample siting plan. See section III.A.3 of this preamble for a detailed discussion of seasonal systems.

• Assessment and corrective action. As part of a treatment tech nique, all PWSs are required to assess their systems when monitoring results show that the system may be vulnerable to contamination. Systems must conduct a simple se lf-assessment (Level 1) or a more detailed assessment (Level 2) depending on the severity an d frequency of contamination. The system is responsible for correcting any sa nitary defect(s) found through either a Level 1 or Level 2Document initiating EO 12866 review

19 assessment. See section III.A.5 of this preamble for more discussion of the treatment technique requirement of the proposed RTCR.

• Violations and public notification . The proposed RTCR establishes an E. coli MCL violation, a treatment technique violation, a monitoring viola tion, and a reporting violation. Public notification is required for each type of violation, with the type of notification dependent on the degree of potential public health concern. This is consistent with EPA’s current public notification requirements under 40 CFR part 141 s ubpart Q. The proposed RTCR also modifies the public notification and Consumer Confidence Report language to reflect the construct of the proposed rule. See sections III.A.6 and III.A.7 of this preamble for detailed discussions of violations and public notifica tion under the proposed RTCR.

• Transition to the RTCR. The proposed RTCR allows all systems to transition to the new rule at their current TCR monitori ng frequency, including systems on reduced monitoring under the current TCR. States will then evaluate the monitoring frequency during each sanitary survey conducted after the compliance effective date of the RTCR. This process reduces State burden by not requiring the State to determine appropria te monitoring frequency at the same time as when the State is trying to adopt primacy, deve lop policies, and train their own staff and the PWSs in the State. The provisions of the proposed RTCR are cont ained in the new 40 CFR part 141 subpart Y, superseding 40 CFR 141.21 beginning three years following the publication of the final revised rule.
A. Proposed Rule Provisions and Rationale
1. Terms used in the proposed RTCRDocument initiating EO 12866 review

20 a. Provisions. i. Clean compliance history. For the purposes of the proposed RTCR, EPA is proposing to define “clean compliance history” as a record of no maximum contaminant level (MCL) violations under 40 CFR 141.63; no moni toring violations under 40 CFR 141.21 or subpart Y; and no treatment tec hnique trigger exceedan ces or treatment technique violations under subpart Y. ii. Sanitary defect. EPA is proposing to define “sanitary defect” as a “defect that could provide a pathway of entry for microbial contamin ation into the distributi on system or that is indicative of a failure or imminent failure in a barrier that is already in place” (USEPA 2008c). iii. Seasonal systems. EPA is proposing to de fine a seasonal system as a non-community water system that is operated three or fe wer calendar quarters per calendar year.
b. EPA’s rationale . i. Clean compliance history. EP A is proposing a definition of “clean compliance history” because without a definition, the use of the phrase could result in multiple interpretations. Clean compliance hi story is one of the criteria a sy stem must meet to be eligible for reduced monitoring. The advisory committ ee recommended this definition (USEPA 2008c, AIP p. 10). ii. Sanitary defect. The advisory committee reco mmended the definition of sanitary defect. The proposed RTCR takes a more preventive appro ach to protect public he alth by establishing a framework for the assessment of public water syst ems to identify sanitary defects and to correct them as appropriate. The first part of the pr oposed definition of a “sanitary defect” focuses on problems in the distribution system that may pr ovide a pathway for contaminants to enter the distribution system and its implication for poten tial exposure to both microbial and chemical contaminants. The second part of the defini tion also recognizes the importance of having barriers in place to prevent the en try of microbial contaminants into the distribution system.Document initiating EO 12866 review

21 Indications of failure or immine nt failure of these barriers are defects that require corrective action. Sanitary defect is a term specific to th e proposed RTCR assessment and corrective action provisions. Sanitary defects are not intended to be linked directly to “significant deficiencies” under the Surface Water Treatment Rule (SWTR) (USEPA 1989b, 54 FR 27486, June 29, 1989) and Ground Water Rule (GWR) (USEPA 2006c , 71 FR 65574, November 8, 2006), although some problems could meet either definition. Noth ing in this proposed rule is intended to limit the existing authorities of St ates under other regulations. The following is a list of examples of sanitary defects and defects in the distribution system coliform monitoring practices (USE PA 2008c, AIP Appendix Y, p. 41). Examples of sanitary defects

• Cross connection and backflow issues such as a required backflow prev ention device not in place or not operating properly; or an unprotected cross connection found.

• Operator issues such as failure to follow st andard operating procedures (SOPs) that protect distribution system integrity and sanitary conditions.

• Distribution system issues such as inadequate inspection and maintena nce of the distribution system; loss of distribution system integrity such as main breaks; failure to maintain adequate pressure; improper flushing operations; improper construction of new, replaced, or renovated lines; inadequate disinf ection during and after repair/replacement activities; or inability to maintain required residual th roughout the distribution system.

• Storage issues such as overflow, vents, ha tches, and other penetrations not properly configured, screened, or sealed; inadequate maintenance of stor age facilities; or inadequate disinfection during and after repair/replacement activities.Document initiating EO 12866 review

22 • Disinfection issues such as in ability to maintain required re sidual throughout the distribution system. iii. Seasonal systems. Seasonal systems fall under the broader cate gory of non-community water systems (NCWS) and therefore are subject to provisions applicable to that category of systems. However, seasonal systems have unique characteristics and timetables that make them particularly susceptible to cont amination. Seasonal systems repr esent a special case in that the shut down and start-up of the water system present opportunities for contamination to enter or spread through the distribution system. For exampl e, loss of pressure after a system’s shut down can lead to intrusion of contaminants. Microbia l growth prior to start- up can result in biofilm formation, which can lead to the accumulation of contaminants. These systems are also more susceptible to contamination due to changes in the conditions of the source water (such as variable contaminant loading due to increased sep tic tank or septic field use), the seasonal nature of the demand, and the stress that the system experi ences. As a result, the Agency is establishing a definition for seasonal systems and setting fort h provisions that mitigate the risk associated with the unique characteristics of this type of system. The advisory committee recommended that such provisions pertain to seasonal systems. See section III.A.3 of this preamble for specific provisions that seasonal systems must meet.

c. Request for comment . EPA requests comment on the proposed definitions and whether they work within the construct of the propos ed RTCR. Specifically, EPA requests comment on the proposed definition of seasonal systems. The advisory committee recommended that seasonal systems be identified and be subject to additional regulatory requirements because the shutdown and startup of the system presents opport unities for contaminants to enter or spread through the distribution system. These results are possible in any system that shuts down andDocument initiating EO 12866 review

23 does not maintain adequate pressure throughout the distribution system. EPA requests comment on whether the proposed definition of “seasonal system ” is adequate to address this concern. For example, a system that operated from March to October would operate in all four calendar quarters and would not be considered a seasona l system, but would be subject to the same possibility of distribution system intrusion as a seasonal system that operated April to November (three calendar quarters). Shoul d EPA modify the definition to a ddress this issue? If so, how should the definition be modified? Should system s that close for some specified period (e.g., 30 days, 60 days, 90 days) be subject to seasonal syst em requirements? What should that specified period be? Systems that operate intermittently (e.g., only on weekends or only when a camp is open) may also be subject to distribu tion system contamination due to lack of adequate pressure. Should this be addressed? If so, how should it be addressed – through regulation, guidance, or some other approach? Is th ere a specific shutdown time th at should be considered for intermittent systems in developing the appro ach and determining which systems should be included? In addition to the public health benefits associated with these requirements, EPA is aware of the burden that States will have in determini ng which systems must comply and in tracking compliance. Therefore, EPA requests comment on ways to reduce State burden and facilitate implementation of seasonal system provisions.
2. MCLG and MCL for E. coli , and coliform treatment technique

a. Provisions. The current TCR established a maximu m contaminant level goal (MCLG) of zero for total coliforms (including fecal coliforms and E. coli ) and an MCL for total coliforms. EPA is proposing in the RTCR to eliminate the MCLG for total coliforms (including fecalDocument initiating EO 12866 review

24 coliforms) and the MCL for total coliforms. Under the proposed RTCR, EPA establishes an MCLG of zero and an MCL for E. coli and a treatment technique for coliform. The proposed MCL for E. coli is based on the monitoring results for total coliforms and E. coli. A system is in compliance with the E. coli MCL unless any of the fo llowing conditions occur:

• A system has an E. coli positive repeat sample following a total coliform-positive routine sample; or

• A routine sample is E. coli -positive and one of it s associated repeat samples is total coliformpositive; or

• A system fails to test for E. coli when any repeat sample tests positive for total coliforms; or

• A system fails to take all required repeat samples following a routine sample that is positive for E. coli

. The proposed MCL is similar to the criteria that define the conditions (if exceeded) when a Tier 1 acute MCL violation occurs unde r the current TCR but with two modifications. First, the proposed MCL excludes fecal coliforms. Second, the proposed MCL also includes an additional condition by which a system violates the MCL, namely failing to collect all repeat samples following an initial E. coli -positive sample. EPA is also proposing a coliform treatment technique, which uses total coliforms and E. coli as indicators of a possible breach in the distribution system that could lead to fecal contamination.
b. EPA’s rationale . i. Inclusion of MCLG for E. coli and removal of MCLG for total coliforms (including fecal coliforms). EPA is proposing in the RTCR to include an MCLG of zero for E. coli and to remove the current MCLG of zero for total co liforms (including fecal coliforms). This is because E. coli is a more specific indicator of fecal contamination and potential harmful pathogens in drinking wate r than are total colif orms (including fecalDocument initiating EO 12866 review

25 coliforms). Many of the organisms detected by to tal coliform and fecal coliform methods are not of fecal origin and do not have any direct public health implication. See also the discussion of fecal coliforms in section III.A.9 of this preambl e. New information has become available since promulgation of the current TCR in 1989 that in dicates that measurement of fecal coliforms sometimes detects organisms that may not have any connection to fecal contamination (Edberg
et al . 2000). An MCLG of zero for E. coli is more appropriate than an MCLG of zero for total coliforms (including fecal coliforms) since E. coli is a more specific indicator of the presence of fecal contamination. Total coliforms (including fecal coliforms) do not in and of themselves pose a public health risk, but they may indicate the presence of a pa thway by which fecal contamination can occur. Therefore, the removal of the MCLG for tota l coliforms (including fecal coliforms) would prevent possible public confusion as a result of attributing greater public health significance to the presence of total coliforms than is warrant ed. EPA believes that the removal of the MCLG for total coliforms, along with the other proposed changes discussed in the succeeding paragraphs, leads to a rule that is more protective of public hea lth, and is less confusing to the public. The proposed MCLG of zero for E. coli and the removal of the MCLG for total coliforms (including fecal coliforms) are also consistent with the recommendation made by the advisory committee in the AIP. ii. Inclusion of MCL for E. coli and removal of MCLs for total coliforms and fecal coliforms. EPA is proposing to include in the RTCR an MCL for E. coli because approved analytical methods continue to be available to measure the presence of E. coli in water samples, i.e., the presence of E. coli is technologically feasible to as certain. Violation of the proposed MCL for E. coli signifies fecal contamination occurrence and a possible high risk of exposure toDocument initiating EO 12866 review

26 pathogens. EPA is proposing to eliminate the MCLs for total coliforms and fecal coliforms because under the proposal there is no longer an MCLG for either total coliforms or fecal coliforms, for the reasons explained earlier. The proposed MCL for E. coli is consistent with the recommendation made by the advisory committee in the AIP. iii. Coliform treatment technique. The 1996 SDWA amendments authorize EPA to promulgate a treatment technique in lieu of an MCL if EPA determines that “it is not economically or technological ly feasible to ascertain the level of the contaminant” (SDWA 1412(b)(7)(A)). While it is technological ly feasible to ascertain levels of E. coli (i.e., analytical methods continue to be availabl e to measure the presence of E. coli in water samples), because of the intermittent nature of fecal contamination, it is not economically feasible to ascertain the level of E. coli occurrence below which the water may be d eemed safe. This is because it is not economically feasible to monitor with sufficient frequency to ensure such safety. Therefore, EPA is proposing a coliform treatment technique for protection against potential fecal contamination to address this concern

. Under the proposed coliform treatment technique , total coliforms serve as an indicator of a potential pathway of fecal contamination into the distribution system. A PWS that exceeds a specified frequency of total coliform occurrence must conduct a Level 1 or Level 2 assessment to determine if any sanitary defect(s) exist(s) and, if found, to correct the defect(s). In addition, under the proposed treatment technique re quirements, a PWS that incurs an E. coli MCL violation must conduct a Level 2 assessment and take remedial action if any sanitary defects are found. See section III.A.5 of this preamble for a full discussion of cond itions that trigger and define Level 1 and Level 2 assessments.Document initiating EO 12866 review

27 The treatment technique requirements as propos ed enhance public health protection beyond the E. coli MCL for the following reasons:

• The assessment and corrective action provisions of the treatment technique when the MCL for E. coli is exceeded requires PWSs to inves tigate the potential causes of the fecal contamination and requires timely remedial ac tion if any sanitary de fects are found. Under the current TCR, there are no requirements for investigation and corrective action after an MCL exceedance. Without such a find-and- fix provision, the pathway for contamination would not be eliminated and sampling alone ma y not be adequate to identify intermittent sources of fecal contamination. The assessm ent and corrective action provisions of the proposed rule increase the likelihood of finding and correctin g the sanitary defect and minimize the chance of recurrence of fecal contamination in the future.

• Using total coliforms in addition to E. coli as an indicator to prompt assessment and corrective action increases the sensitivity for identifying potential pathways for contamination. The presence of total coliforms indicates the potential existence of a pathway through which fecal contamination could follo w. Analyses from EPA’s 2005 Six-Year Review 2 data (USEPA 2006b) (see section VI.B of this preamble for details on the Six-Year Review 2 data) and from the proposed RTCR Economic Analysis (EA) occurrence modeling show that total coliform presen ce in drinking water is approximately 20 to 40 times higher than E. coli occurrence in drinking water (see chap ter 4 of the Proposed RTCR EA (USEPA 2009a)). Similarly, under the current TCR, non- acute MCL (also referred to as monthly MCL) violations (informed by total coliform o ccurrence) occur roughly 10 times more often than acute MCL violations (i nformed by total coliform and E. coli occurrence, essentially equivalent to the occurrence that triggers an E. coli MCL violation under this proposed rule).Document initiating EO 12866 review

28 Thus, including monitoring of total coliforms, as well as E. coli , as part of a treatment technique to indicate when sy stems must find and fix any san itary defects, substantially increases the likelihood of iden tifying such defects.

• The proposed treatment technique was supported by the advisory committee and is consistent with the recommendations in the AIP. See AIP, pages 6-7.

c. Request for comment. EPA requests comment on its proposal to eliminate the MCLG and MCL provisions for total coliforms and fecal coliforms and to include an MCLG and MCL for E. coli and coliform treatment techni que provisions based on mon itoring for total coliforms and E. coli . EPA also requests comment on its proposed definition of the E. coli MCL.
3. Monitoring

a. Provisions. As with the current TCR, the proposed RTCR requires all PWSs to collect and test samples for total coliforms and E. coli according to a sample siting plan and schedule specific to the system. Under the proposed RTCR, all PWSs are still requ ired to take repeat samples within 24 hours of learning of any rout ine monitoring sample that is total coliformpositive. PWSs must comply with the repeat monitoring requirements and E. coli analytical requirement, discussed in detail in section III. A.4 of this preamble. All samples taken for proposed RTCR compliance (routine and repeat) may occur at a customer’s premises, dedicated sampling station, or other designate d compliance sampling location. Under the proposed RTCR, system sample si ting plans must include routine and repeat sample sites and any sampling points necessa ry to meet the Gr ound Water Rule (GWR) requirements. The sample siting plan is subj ect to State review a nd revision. The PWS may propose repeat monitoring locations that are expe cted to be representative of a pathway for contamination into the distribution system (for example, near a storage tank). Instead ofDocument initiating EO 12866 review

29 identifying set repeat sampling locations (i.e., within five service connections upstream and downstream of the original sampling location that tested total coliform-positive), systems may elect to specify criteria for se lecting their repeat sampling loca tions on a situational basis in a standard operating procedure (SOP ), which is part of the sample siting plan. Upon State review, the PWS must demonstrate to the State’s satis faction that the sample siting plan remains representative of the water quality in the distri bution system. The State may modify the SOP as needed. To address access issues, small systems must specify in their sampling plans where the two additional samples will be taken. The State may determine that monitoring at the entry point to the distribution system (especially for undisinfected ground water systems) is effective to differentiate between pot ential source water and distribution problems. Under the proposed RTCR, PWSs may take more than the minimum required number of routine samples and include the results in calc ulating whether the total coliform treatment technique trigger for conducting an assessment has been exceeded only if the samples are taken in accordance with the sample siting plan a nd are representative of water throughout the distribution system (see sections II I.A.3 and III.A.5 of this preamble). EPA is not proposing to make substantive ch anges to the current TCR requirements for (1) special purpose samples, and (2) invalidation of total coliform samples. EPA is proposing a minor modification to the provision for special purpose samples by changing “total coliform MCL” to “coliform treatment technique trigger.” The following are the proposed monitoring re quirements for different categories of systems. i. Ground water NCWSs serving ≤ 1,000 people. (a)

. Routine monitoring . The proposed RTCR requires ground water NCWS serving 1,000 or fewer people to routinely monitor eachDocument initiating EO 12866 review

30 quarter for total coliforms and E. coli . Seasonal systems under th is category must routinely monitor every month (seasonal systems are discussed later in this section). (b). Transition to the RTCR . The proposed RTCR requires all ground water NCWSs serving 1,000 or fewer people, including s easonal systems, to continue with their TCR monitoring schedules as of the compliance date of the RTCR, unless or until any of the conditions for increased monitoring discussed later on in this section are triggered on or after the compliance date or unless otherwise directed by the St ate, including through the special monitoring evaluation conducted unde r a sanitary survey. This rule proposes that after the compliance date of the final RTCR, during each sanitary survey the State (which would be either EPA or a State that has received primacy for this rule) must perform a special monitoring evaluation to review the status of the water system, including the distribution system, to determine whether the system is on an appropriate monitoring schedule and modify the monitoring schedule as nece ssary. States must ev aluate system factors such as the pertinent water quality and compliance history, the establishment and maintenance of contamination barriers, and othe r appropriate protecti ons and validate the appropriateness of the water system’s existing monitoring schedule and modify as necessary. For seasonal systems on quarterly or annual monitoring, this evaluation must also include re view of the approved sample siting plan which designates the time period(s) for monitoring based on site-specific considerations (such as during periods of highest demand or highest vulnerability to contamination). The system must collect compliance samples during these time periods. Systems on annual monitoring, including seasonal sy stems, must have an initial annual site visit by the State within one year of the co mpliance date (or an annual voluntary Level 2Document initiating EO 12866 review

31 assessment by a party approved by the State) and an annual site visit each year thereafter to remain on annual monitoring. (c). Reduced monitoring . The State has the discretion to reduce the monitoring frequency for well-operated ground water NCWSs from the quarterly routine mon itoring to no less than annual monitoring, if the water system can demons trate that it meets the criteria for reduced monitoring provided in this section. To be eligible to qualify for and remain on annual monitoring after the compliance date, a ground water NCWS serving 1,000 or fewer people must meet all of th e following criteria:

• The most recent sanitary survey shows the system is free of sanitary defects, has a protected water source and meets approved construction standards;

• The system must have a clean compliance history (no MCL violations or monitoring violations under the current TCR and/or pr oposed RTCR, no Level 1 or Level 2 trigger exceedances or treatment technique violations under the proposed RTCR) for a minimum of 12 months. (For a more detailed discussion on Level 1 and Level 2 triggers, see section III.A.5 of this preamble); and

• An initial site visit by the State within the last 12 months to qua lify for reduced annual monitoring, and recurring annually to stay on reduced annual monitori ng; and correction of all identified sanitary defects. A voluntary Level 2 assessment by a party approved by the State may be substituted for the State annual site visit in any given year. (d). Increased monitoring . Ground water NCWS serving 1,000 or fewer people on quarterly or annual monitoring that experience any of th e following events must begin monthly monitoring the month following the event:Document initiating EO 12866 review

32 • The system triggers a Level 2 assessment or two Level 1 assessments in a rolling 12 month period;

• The system has an E. coli MCL violation;

• The system has a coliform treatment technique vi olation (for example, if the system fails to conduct a Level 1 assessment or correct for sa nitary defects if re quired to do so); or

• The system on quarterly monitoring has two mo nitoring violations in a rolling 12-month period or system on annual monitori ng has one monitoring violation. The system must continue monthly monitoring until the requirements in this section for returning to quarterly or annual monitoring are met. (e). Requirements for returning to quarterly monitoring . To be eligible to return to quarterly monitoring, ground water NCWSs serving 1,000 or fe wer people must meet all of the following criteria:

• Within the last 12 months, the system must have a completed sanitary survey or a site visit by the State or a voluntary Level 2 assessment by a party approved by the State. The system is free of sanitary defects, and ha s a protected water source; and

• The system has a clean compliance history (no E. coli MCL violations, Level 1 or 2 triggers, coliform treatment technique violations or monitoring violations) for a minimum of 12 months. (f). Requirements for returning to reduced annual monitoring. To be eligible to return to reduced annual monitoring after being placed on in creased monitoring, the system must meet the criteria to return to routine quarterly monitoring plus the following criteria:Document initiating EO 12866 review

33 • An annual site visit (recu rring) by the State and correction of a ll identified sanitary defects. An annual voluntary Level 2 assessment may be s ubstituted for the State annual site visit in any given year; and

• The system must adopt one or more additional enhancements to the water system barriers to contamination as approved by the State. Thes e measures could include but are not limited to the following:

− Cross connection control, as approved by the State;

− An operator certified by an appropriate Stat e certification program, which may include regular visits by a circuit rider;

− Continuous disinfection entering the distribution system and a residual in the distribution system in accordance with criteria specified by the State; and

− Maintenance of at least a 4-l og inactivation or removal of viruses each day of the month based on daily monitoring as specified in the GWR (with allowance for a 4-hour exception).

− Other equivalent enhancements to water system barriers as approved by the State. (g). Seasonal systems . The proposed rule requires a ll seasonal systems to demonstrate completion of a State-approved start-up procedure on and after the compliance date of the final RTCR. Seasonal systems may continue with their TCR monitoring frequency after the compliance date of the final RTCR unless or unti l any of the conditions for increased monitoring discussed previously are triggere d on or after the compliance date or as directed by the State. Under the proposed RTCR, seasonal systems are re quired to take routine samples monthly. To be eligible for reduced monitoring after the compliance date, seasonal systems must meet the following criteria:Document initiating EO 12866 review

34 • The system must have an approved sample siting plan that designates the time period for monitoring based on site-specific consideratio ns (e.g., during periods of highest demand or highest vulnerability to contam ination). The system must collect compliance samples during this time period; and

• To be eligible for reduced quarterly monitori ng, the system must also meet all the reduced monitoring criteria discu ssed in section III.A.3.a.i .(e) of this preamble, Requirements for returning to quarterly monitoring

.

• To be eligible for reduced annual monitoring, the system must also meet all the reduced monitoring criteria discu ssed in section III.A.3.a.i .(f) of this preamble, Requirements for returning to reduced annual monitoring

. (h). Additional routine monitoring . All systems collecting samp les on a quarterly or annual frequency must conduct additional routine mon itoring following a single total coliform-positive sample (with or without a Level 1 trigger event). The additional routine monitoring consists of three samples in the month following the total coliform-positive sample at routine monitoring locations identified in the sample siting plan. Th is is a change from the current TCR additional routine monitoring requirement of taking a total of five samples the month following a total coliform-positive sample for systems that take four or fewer samples per month. In this proposal, consistent with the current TCR, the State may waive the add itional routine monitoring requirement if:

• The State, or an agent approved by the State, pe rforms a site visit before the end of the next month the system provides water to the public . Although a sanitary survey need not be performed, the site visit must be sufficiently detailed to allow the State to determine whether additional monitoring and/or any corrective actio n is needed. The State cannot approve anDocument initiating EO 12866 review

35 employee of the system to perform this site vi sit, even if the employee is an agent approved by the State to perform sanitary surveys.

• The State has determined why the sample was total coliform-positive and establishes that the system has corrected the problem or will correct the problem before the end of the next month the system serves water to the public. In this case, the State must document this decision to waive the following month's additional monitoring requirement in writing, have it approved and signed by the supervis or of the State official who recommends such a decision, and make this document available to the EP A and public. The written documentation must describe the specific cause of the total colifo rm-positive sample and what action the system has taken and/or will take to correct this problem. The State may not waive the requirement to collect three additional routine samples the next month in which the system provides water to th e public solely on the grounds that all repeat samples are total coliform-negative. If the Stat e determines that the system has corrected the contamination problem before the system take s the set of repeat samples required in §141.858, and all repeat samples were total coliform-nega tive, the State may waive the requirement for additional routine mon itoring the next month. All additional routine samples are included in determining compliance with the MCL and coliform treatment technique requirements. ii. Ground water CWSs serving ≤ 1,000 people. (a). Routine monitoring . The proposed RTCR requires ground water CWSs serving 1,000 or fewer people to routinely monitor each month for total coliforms and E. coli

.Document initiating EO 12866 review

36 The State may reduce the monitoring freque ncy for ground water CWS from the monthly routine monitoring to quarterly re duced monitoring if the water system can demonstrate that it meets the criteria for reduced monitoring provided later in this section (b). Transition to the RTCR . All ground water CWSs serving 1,000 or fewer people continue with their current TCR monitoring sc hedules unless or until any of the increased monitoring requirements in this section occur or as directed by the State. After the compliance date of the final RTCR, the State must determine whether the system is on an appropriate monitoring schedule by perf orming a special monitoring evaluation during each sanitary survey to review the status of the PWS, including the distribution system. The State must evaluate system factors such as th e pertinent water quality and compliance history, the establishment and maintenance of barrier s to contamination, and other appropriate protections to validate the water system’s existin g monitoring schedule or require more frequent monitoring. (c). Reduced monitoring . The State has the flexibility to reduce the monitoring frequency for well-operated ground water CWS from the m onthly routine monitoring to no less than quarterly monitoring if the water system can dem onstrate that it meets the criteria for reduced monitoring provided in this section. To be eligible for quarterly reduced m onitoring, ground water CWSs serving 1,000 or fewer people on monthly monitoring after the complian ce date must be in compliance with Statecertified operator provisions and meet each of the following criteria:

• The most recent sanitary survey shows the syst em is free of sanitary defects (or has an approved plan and schedule to correct them), has a protected water source, and meets approved construction standards;Document initiating EO 12866 review

37 • The system must have a clean compliance history (no MCL violations or monitoring violations under the current TCR and/or pr oposed RTCR, no Level 1 or Level 2 trigger exceedances or treatment technique violations under the proposed RTCR) for a minimum of 12 months; and

• The system must meet at least one of the following criteria:

− An annual site visit by the St ate or a voluntary Level 2 as sessment by a party approved by the State and correction of all identified sa nitary defects (or an approved plan and schedule to correct them), or

− A cross connection control program, as approved by the State, or

− The system must maintain continuous disinf ection entering the dist ribution system and a residual in the distribution system in accordan ce with criteria specifi ed by the State, or

− The system must maintain at least a 4-log in activation or removal of viruses each day of the month based on daily monitoring as speci fied in the GWR (with allowance for a 4- hour exception) (USEPA 2006c, 71 FR 65574, November 8, 2006); or

− Other equivalent enhancements to wa ter systems as approved by the State. (d). Return to routine monitoring requirements . When a system on quarterly monitoring experiences any of the following events th e system must begin monthly monitoring:

• System triggers a Level 2 assessment or tw o Level 1 assessments in a rolling 12 month period;

• System has an E. coli MCL violation;

• System has a coliform treatment technique vi olation (e.g., fails to conduct a Level 1 or Level 2 assessment or to correct for a sani tary defect if required to do so); or

• System has two routine monitoring viol ations in a rolli ng 12-month period.Document initiating EO 12866 review

38 The system must continue monthly monitoring until all the reduced monitoring requirements discussed previously in this section are met. A system that loses its certified operator must also return to monthly monitoring the month following the loss. (e). Additional routine monitoring . All systems collecting samples on a quarterly frequency must conduct additional routine monitoring follo wing a single total coliform-positive sample (with or without a Level 1 trigger event). The additional routine monitoring consists of three samples in the month following the total coliform-positive sample at routine monitoring locations identified in the sample siting plan. The current TCR additional routine monitoring requirements consist of taking a total of five samples the month following a total coliformpositive sample for systems that take four or fewer samples per month. In this proposal, consistent with the current TCR, the State may waive the additional routine monitoring requirement if:

• The State, or an agent approved by the State, pe rforms a site visit before the end of the next month the system provides water to the public . Although a sanitary survey need not be performed, the site visit must be sufficiently detailed to allow the State to determine whether additional monitoring and/or any corrective actio n is needed. The State cannot approve an employee of the system to perform this site vi sit, even if the employee is an agent approved by the State to perform sanitary surveys.

• The State has determined why the sample was total coliform-positive and establishes that the system has corrected the problem or will correct the problem before the end of the next month the system serves water to the public. In this case, the State must document this decision to waive the following month's additional monitoring requirement in writing, have it approved and signed by the supervis or of the State official who recommends such a decision,Document initiating EO 12866 review

39 and make this document available to the EP A and public. The written documentation must describe the specific cause of the total colifo rm-positive sample and what action the system has taken and/or will take to correct this problem. The State may not waive the requirement to collect three additional routine samples the next month in which the system provides water to th e public solely on the grounds that all repeat samples are total coliform-negative. If the Stat e determines that the system has corrected the contamination problem before the system take s the set of repeat samples required in §141.858, and all repeat samples were total coliform-nega tive, the State may waive the requirement for additional routine mon itoring the next month. All additional routine samples are included in determining compliance with the MCL and the coliform treatment technique requirements. iii. Subpart H systems serving ≤ 1,000 people

. The monitoring requirements for subpart H systems (PWSs supplied by surface water sour ce or ground water source under the direct influence of surface water (GW UDI)) serving 1,000 or fewer people remain the same as under the current rule (see §141.856). These systems ar e not eligible for reduc ed monitoring. In addition, the proposed rule requires all seasonal systems, on and af ter the compliance date of the final RTCR, to demonstrate completion of a State-approved start-up procedure. iv. PWSs serving > 1,000 people

. The monitoring requirements for PWSs serving more than 1,000 people remain the same as under the curr ent TCR (see §141.857), with the exception of the applicable revisions to the re peat sampling locations provide d in §141.858 and additional routine monitoring provisions. System s on monthly monitoring are not required to take additional routine samples the month following a total coliform-positive sample. These systems are not eligible for reduced monitoring. In addition, th e proposed rule requires all seasonal systems, onDocument initiating EO 12866 review

40 and after the compliance date of the final RTCR, to demonstrate completion of a State-approved start-up procedure.
b. EPA’s rationale. i. Sampling sites and monitoring plans. Consistent with current practice, the proposed RTCR requires systems to develop a sample siting plan that is representative of the wa ter throughout the distribution system. EPA is proposing to maintain the provision from the current TCR that indicates that sample siting plan s are subject to State review and revision. The advisory committee recommended that States review and revise sample siting plans consistent with current practice and that the State develops and implements a process to ensure the adequacy of sample siting plans incl uding a periodic review. The advisory committee also recommended that specific elements be incl uded in the sampling plans such as the routine and repeat sample sites and sampling locations nece ssary to meet the requirements of the GWR. Alternative repeat monitoring locat ions (e.g., at storage tanks and en try points to the distribution system) are subject to State approval. The syst em must demonstrate to the State’s satisfaction that these alternative monitoring locations are representative of the water quality in the distribution system. By allowing systems to specify criteria for se lecting their repeat samp ling locations in their SOP instead of setting fixed repeat sampling loca tions, systems can provide a more flexible and more protective response. The system can focus the repeat samples at locations that will best verify and determine the extent of potential co ntamination of the distribution system based on specific situations. EPA is proposing to allow the use of dedicate d sampling locations for the following reasons:Document initiating EO 12866 review

41 • To reduce potential contamination of the taps. Utilities will have more control to prevent contamination of the tap by preventing its us e by unauthorized persons and allowing no routine use of the ta p except for sampling;

• To facilitate access to sampling taps. Currently systems may be constrained by where they sample, e.g., only at public buildings or in certain individual customer’s houses.

• To improve sampling representation of the di stribution system. Allowing dedicated sample taps in areas where systems have not been able to gain access will f acilitate better sampling representation of the distribution system. ii. Ground water PWSs serving ≤ 1,000 people. (a). Routine monitoring . The advisory committee recommended that ground water NCWS s serving 1,000 or fewer people remain under a routine quarterly monitoring as provided in the current TCR. They believed that in conjunction with the assessment and corrective action requi rements, public health protection would be maintained or improved without increasing sampli ng costs over current TCR requirements. The advisory committee also recognize d that current sampling costs ar e not insignificant for small systems, and wanted to recognize the good performa nce of systems by allowing them to be able to continue to qualify for reduced monitoring, but under the more specific and rigorous criteria described previously. To conti nue to provide adequate health protection, systems on reduced monitoring must adhere to criteri a that ensure that barriers ar e in place and are effective. Furthermore, systems with problems that may i ndicate poor system integr ity, maintenance, or operations, or systems that fail to monitor, are tr iggered into monthly monitoring. This approach leverages the limited resources of these sma ll ground water NCWSs and of States, so that systems with minimal problems can minimize their costs and States can focus their resources on systems needing the greatest attention, such as systems with problems or vulnerabilities.Document initiating EO 12866 review

42 The advisory committee thought it best to continue with existing routine monthly monitoring requirements for ground water CWSs serving 1,000 or fewer people in order to maintain the current levels of effort to identify potential problems. Since sanitary surveys are required under the GWR and these surveys provide subs tantial diagnostic value and corrective action response for problems identified, specifyin g higher routine monitoring frequency for these systems was not deemed necessary. These syst ems may also qualify for reduced monitoring if they meet certain criteria. (b). Transition to the RTCR . The advisory committee was concerned about the ability of the States and systems to adopt the new regulations and to make all the determinations that may be necessary to determine the appr opriate monitoring frequency within three years of rule promulgation. Requiring significant changes in monitoring frequencies in a short period (i.e., without a transition period) could overwhelm State resources. The advisory committee recommended phasing in the requirements and using the sanitary survey process to facilitate a successful transition and implementation. The advi sory committee, therefore, recommended that these systems continue with their current m onitoring frequency during a transition period and that the State review the monito ring frequency to determine whethe r it is appropriate during each sanitary survey (USEPA 2008c, AIP p.9). This gives the systems the opportunity to address operation and maintenance issues to maintain existing monitoring frequency or qualify for reduced monitoring. Systems currently on reduced monitoring could stay on reduced monitoring during the transition period and st ay on reduced monitoring after th at time if they meet certain criteria. (c). Reduced monitoring . The reduced monitoring require ments are intended to recognize that well-operated systems may be less vulnera ble to contamination. Therefore, certainDocument initiating EO 12866 review

43 conditions are specified under which reduced m onitoring could be allowed. These include a clean compliance history for a mi nimum of 12 months, and an a nnual visit from the State for systems taking one sample per year and correctio n of all identified sanitary defects. Ground water NCWSs serving 1,000 or fewer people, w ith a routine quarterly monitoring frequency, could qualify for reduced annual monitoring, while ground water CWSs serving 1,000 or fewer people, with a routine monthly monitoring fr equency, could qualify for reduced quarterly monitoring. For NCWSs on annual monitoring, the advisory committee believed that requiring a system to have an annual site visit or a Level 2 assess ment provides at least an equivalent level of diagnosis of problems and vulnera bilities that might exist as co mpared to quarterly monitoring without an annual site visit. Se veral States have elected to conduc t annual site visits while also doing annual monitoring for some NCWSs. (d). Increased monitoring requirements for NCWSs . The advisory committee wanted to recognize that if certain vulnerabi lities are identified in a system , the system should be required to conduct more frequent monitoring to identif y and correct its proble ms and better protect public health. Other than sanitary surveys or othe r site visits, monitoring is the primary means to identify pathways for potential contamination. If the system is deemed more vulnerable to such pathways, as indicated by the increased monito ring criteria, it must conduct more monitoring. (e). Requirements for returning to routine monitoring and reduced monitoring . The advisory committee believed that systems that addr ess or correct vulnerab ilities as indicated by a clean compliance history should be allowed to retu rn to routine monitoring, and subsequently to reduced monitoring (for NCWS). This provisi on allows for reduced monitoring costs.Document initiating EO 12866 review

44 (f). Seasonal systems . The advisory committee recogni zed that seasonal systems have unique characteristics that make th em more susceptible to contam ination. These systems do not maintain pressure while not in operation, which ca n result in the intrus ion of contaminants. During the time when a seasonal system is not in operation, septic tank drain fields or other pollution sources may accumulate that could affect the conditions or quality of the source water (especially for intermittent contaminants) that infrequent monitoring may not be able to capture. If monitoring is done only at the start-up, there may not be enough time for the system to reach equilibrium (i.e., there might not be enough time to recognize if microorga nisms from a septic tank moved to the wellhead in seasonally opera ted systems). Therefore, the proposed rule requires seasonal systems to monitor routinely at a monthly frequency. Seasonal systems can qualify for reduced monitoring if they meet certain criteria. For a seasonal system to be allowed to monitor at a reduced frequency, the proposed ru le requires the system to have an approved sample siting plan that designates the time period for monitoring and takes into consideration site-specific conditions. A syst em on a reduced monitoring sche dule (less than monthly) must collect samples when there is the greatest chance that contamination could be identified and, due to the variability in water demands, wh en systems could be most challenged. (g). Additional routine monitoring . EPA is proposing to retain the requirement of taking additional routine samples the month following a total coliform-positive sample for systems on quarterly or annual monitoring. The advisory committee recognized both the benefits and the limitations of additional routine monitoring. A dditional routine samples are meant to enhance the diagnostic ability and supplement the infreque nt routine monitoring of systems on quarterly or annual monitoring. Without the provision of additional monitoring, systems on annual or quarterly monitoring with a total coliform-pos itive sample would not take any samples theDocument initiating EO 12866 review

45 following month. The advisory committee believ ed that additional samples collected the following month are appropriate to help rec ognize the problem if it still persists. For systems required to take the additiona l routine samples the following month (i.e., systems on quarterly or annual monitoring), th e proposed RTCR changes the requirement from taking a total of five routine samples to a requ irement of just three routine samples. The advisory committee recognized that it is appropriate to drop from five to three samples the following month to reduce monitoring costs whil e still maintaining a su bstantial likelihood of identifying a problem if a problem persists. EP A recognizes that a reduc tion in the number of samples taken could also mean a reduction in the number of positive samples found. However, the reduction in the number of additional ro utine samples in conjunction with the new assessment and corrective action provisions of th e proposed RTCR (discussed in section III.A.5 of this preamble) leads to a rule that is ultimately more pr otective of public health (i.e., more E. coli MCL violations being prevented) and improveme nt in water quality (i.e., decrease in the total coliform and E. coli -positive hit rates observed as shown by the Proposed RTCR EA occurrence modeling results). See chapter 6 of the Proposed RTCR EA (USEPA 2009a) for more details. For systems taking at least one sample m onthly, the advisory committee recommended no additional routine samples for these systems for the following reason. Taking no additional routine samples the following m onth substantially reduces monito ring costs. The assessment and corrective action provisions will give systems the ability to identify and prevent the occurrence of problems. EA modeling results show that although there is a decr ease in the number of E. coli MCL violations found with the decrease in the nu mber of additional routine samples taken (i.e., going from five samples to one during the month following a total coliform-positive), theDocument initiating EO 12866 review

46 assessment and corrective action provisions leads to more E. coli MCL violations being prevented compared to the current TCR (see Exhibit 6-7 of the Proposed RTCR EA (USEPA 2009a) for more details). In addition, whenever a total coliform-positive o ccurs during routine sampling, there is also a requirement to conduct repeat sampling to determin e the extent of contamination or if potential pathways to contamination persist. For sma ll systems serving 1,000 or fewer people on monthly monitoring, if a repeat sample is total colifor m-positive, at least a Level 1 assessment will be triggered. If a sanitary defect (s) is (are) found, the system is required to correct the sanitary defect(s). For systems on monthly monitoring, the asse ssment and corrective action provisions and the repeat sampling provisions mitigate the need for additional routine sampling for the following month. iii. Subpart H systems serving ≤ 1,000 people. EPA is not propo sing to change the routine monitoring requirements for systems using su rface water or GWUDI serving 1,000 or fewer people, which include not allowing reduced monitoring for these systems. Since systems using surface water or ground water under the influence of surface water tend to have much higher levels of contaminants in their source water, a nd in general have more complex operations than ground water systems, it is appropriate to al low reduced routine monitoring for ground water systems but not for subpart H systems. The a dvisory committee recommended that no reduced routine monitoring provisions be allowed for subpart H systems serving 1,000 or fewer people. iv. Public water systems serving > 1,000 peopl e. EPA is proposing to eliminate the additional routine samples the month following a total coliform-positive sample for PWSs serving between 1,000 and 4,100 people for the same reasons discussed previously for smallDocument initiating EO 12866 review

47 ground water systems monitoring monthly. PWSs serving more than 1,000 people are currently required to routinely monitor monthly (one to four samples per month depending on size) and continue to do so under the proposed RTCR.

c. Request for comment . EPA requests comment on the pr oposed monitoring requirements for PWSs. Specifically, EPA requests comment on the following questions: Are there other issues that EPA should consider in its approach to help systems transition to the RTCR? Should EPA develop guidance that woul d help States identify seasonal systems and implement the RTCR requirements (e.g., suggestions for start up procedures and identifying vulnerable time periods)? EPA also requests comment on whet her seasonal systems should be required to comply with State-directed shut down procedur es (in addition to st art-up procedures). EPA requests comment on the following additiona l questions: Should daily measurement of chlorine residual count toward the maximum re sidual disinfectant level (MRDL) monitoring and be one of the criteria for reduced monitoring? Should NTNCWSs be require d to comply with the CWS requirements (as they are in other rules such as DBP rules) since NTNCWSs serve the same people over time and include populations that may be at greater risk (e.g., schools, hospitals, nursing homes)? Will the reduced, routine, and increased monitoring requirements for NCWSs shift the fixed State resources from CWS oversight to NCWS oversight in those States with large numbers of NCWSs? If so, what might be done to limit the impact? Should EPA develop guidance on how to develop a sample s iting plan? Should sample siting plans require State approval? EPA and the advisory committee did not identify any specific i ssues regarding consecutive systems in the proposed RTCR. EPA requests co mment on whether there are such issues and how they should be addressed in the RTCR.Document initiating EO 12866 review

48 4. Repeat samples

a. Provisions. Under the proposed RTCR, all system s must take at least three repeat samples for each routine total coliform-positive sample. This is a change from the current TCR requirements where systems serving 1,000 or fewer people must collect at least four repeat samples while the rest of the systems must collect three repeat samples. EPA is not changing the following provisions: the 24-hour limit within which the system must collect the repeat samples; the authority of the State to extend this limit on a case-by-case basis; and the non-waiver by the State of the requirement for a syst em to collect repeat samples. In addition to taking repeat samples, systems must test each routine total coliform-positive sample for E. coli . They must also test any repeat total coliform-positive sample for E. coli . As with the current TCR, if E. coli is present, the system must notif y the State the same day it learns of the positive result or by the end of the next bu siness day at the latest. The proposed rule is not changing the provision that a State has the discretion to allow the system to forgo E. coli testing in cases where the system assumes that the total coliform-positive sample is E. coli -positive. If the State allows a system to forgo E. coli testing, the system must still notify the State and comply with the E. coli MCL requirements specified in §141.858. As with the current TCR, the system must co llect at least one repeat sample from the sampling tap where the original total coliform-positive sample was taken, and at least one repeat sample at a tap five service connections upstream, and at least one repeat sample at a tap within five service connections downstr eam of the original sampling site. The State may waive the requirement to collect at least one repeat sa mple upstream or downstream of the original sampling site if the total coliform-positive sample is at the end of the distribution system, or one service connection away from th e end of the distribution system. The system may also proposeDocument initiating EO 12866 review

49 alternative repeat monitoring locatio ns as discussed in this section. Under the proposed rule, ground water systems (G WSs) required to conduct triggered source monitoring under the GWR must take ground water source samples in addition to the repeat samples. However, a ground water system serving 1,000 or fewer people may use a repeat sample collected from a ground water source to m eet both the repeat monitoring requirements of the proposed RTCR and the source water monitori ng requirements of the GWR, but only if the State approves the use of a single sample to meet both rule requireme nts (i.e., a dual purpose sample) and the use of E. coli as a fecal indicator for source water monitoring. If the sample is
E. coli -positive, the system violates the E. coli MCL under the proposed RTCR and must also comply with the GWR requirements following a fecal indictor-positive sample. These provisions are consistent with the GWR. If a system with a limited number of monito ring locations (such as a system with only one service connection or a campground w ith only one tap) takes more th an one repeat sample at the triggered source water monitoring location, the system may reduce the number of additional source water samples by the number of repeat sa mples taken at that location that were not E. coli -positive. For example, if a system takes two dual purpose samples and one is E. colipositive and the other is E. coli -negative, the system is require d to take four additional source water samples, rather than five, under the GWR (see 40 CFR 141.402(a)(3)). If the system takes more than one repeat sample at the triggered source water monitoring location and has more than one repeat sample that is E. coli -positive, then the system would have an E. coli MCL violation under the proposed RTCR and a second fecal indi cator-positive source sample under the GWR. The system would then need to also comply with the treatment technique requirements under 40
CFR 141.403.Document initiating EO 12866 review

50 Under the proposed rule, the system must co llect all repeat samples on the same day consistent with current TCR requirements. The State may allow systems with a single service connection to collect the required set of repeat samples over a three-day period or to collect a larger volume repeat sample(s) in one or more samp le containers of any size, as long as the total volume collected is at least 300 ml. The proposed RTCR is not changing the requirem ent that systems collect an additional set of repeat samples for each total coliform-positive repeat sample. As with the original set of repeat samples, the system must collect the a dditional repeat samples within 24 hours of being notified of the positive result, unless the State ex tends the time limit. The system must repeat this process until either total coliforms are not detected in one complete set of repeat samples or the system determines that the coliform treat ment technique trigger has been exceeded and notifies the State. After a trigger (see section III. A.5 of this preamble) is reached, the system is not required to conduct more than on e additional round of repeat monitoring. The proposed RTCR is also not changing the current TCR provision that a subsequent routine sample, which is within five service c onnections of the initial routine sample and is collected after an initial routine sample but before the system learns the initial routine sample is total coliform-positive, may count as a repeat sample instead. Results of all routine and repeat samples not invalidated by the State must be used to determine whether the coliform treatment techni que trigger has been exceeded (see section III.A.5 of this preamble for a discussion of th e coliform treatment technique triggers).
b. EPA’s rationale . i. Why EPA is maintaining a pr ovision for repeat sampling. As with the current TCR, the proposed RTCR requires sy stems to take repeat samples after a total coliform-positive sample. EPA believes that sampling immediately after an initial positiveDocument initiating EO 12866 review

51 sample (i.e., conducting repeat sampling) incr eases the likelih ood of identifying the source and/or nature of the possible contamination. Analysis conducted by EPA indicated that once a total coliform-positive is found, there is a much greater likelihood of finding another total coliform-positive within a short period of time of the initial finding (see Exhibit III-1). Repeat sampling (when total coliform-positive) can indi cate a current pathway for potential external contamination into the distribution system. EPA used the Six-Year Review 2 data to support statistical m odeling which produced estimates of average occurrence of routine total coliform-positive samples and repeat total coliform-positive samples and to characterize how occurrence varies from system to system. EPA’s occurrence model assumes that, among similar systems, the positive rate for total coliforms in routine samples varies as a beta ra ndom variable. EPA used the Six-Year Review 2 data to estimate the parameters for the distribu tion of occurrences of routine and repeat total coliform-positive samples. Exhibit III-1 shows the relative probability of finding a total coliform-positive result from routine samples versus from repeat samples for 27 basic subsets of systems. The table combines regular routine and additional rou tine samples since no distinction was available for the Six-Year Review 2 data set. The relative probability is defined as the ratio of the probability of getting a total coliform-positive result from a repeat sample to the probability of getting a total coliformpositive result from a routine sample.
Exhibit III-1 Relative Probability of Total Coliform-P ositive Samples in Routine Compared to Repeat Samples.Document initiating EO 12866 review

52 System type 1 Average pRTTC 2 Average pRPTC 3 Ratio pRPTC / pRTTC TNCWS undisinfected GW <101 4.8% 28% 5.9 101-1,000 4.8% 25% 5.2 1,001-4,100 2.5% 17% 6.9 NTNCWS undisinfected GW <101 3.7% 26% 7.0 101-1,000 2.7% 26% 9.6 1,001-4,100 2.7% 26% 9.6 CWS undisinfected GW <101 3.1% 19% 6.0 101-1,000 2.7% 19% 7.1 1,001-4,100 2.7% 13% 4.9 TNCWS disinfected GW <101 2.3% 14% 6.2 101-1,000 2.3% 14% 6.2 1,001-4,100 2.3% 14% 6.2 NTNCWS disinfected GW <101 1.6% 11% 6.7 101-1,000 1.1% 11% 9.4 1,001-4,100 1.1% 11% 9.4 CWS disinfected GW <101 1.6% 9.4% 5.9 101-1,000 1.2% 9.4% 7.6 1,001-4,100 0.78% 5.2% 6.7 TNCWS SW <101 2.3% 14% 6.2 101-1,000 2.3% 14% 6.2 1,001-4,100 2.3% 14% 6.2 NTNCWS SW <101 1.6% 11% 6.7 101-1,000 1.1% 11% 9.4 1,001-4,100 1.1% 11% 9.4 CWS SW <101 1.5% 6.5% 4.3 101-1,000 0.95% 6.5% 6.8 1,001-4,100 0.59% 3.4% 5.8 1 The following acronyms are used: (1) TNCWS Tr ansient Non-Community Water System; (2) NTNCWS Non-Transient Non-Community Water System; (3) CWS Community Water System; (4) GW Ground Water; (5) SW Surface Water 2 Average probability of a total coliform-pos itive from a routine total coliform sample 3 Average probability of a total coliform-positive from a repeat total coliform sampleDocument initiating EO 12866 review

53 Exhibit III-1 shows that for any type and size of system, regardless of source water and disinfection practice, repeat to tal coliform samples (triggered by positive routine samples) are much more likely to be positive than are rou tine samples. For small (serving 100 or fewer people) CWSs that provide undisinfected ground water, the average repeat total coliformpositive rate (19 percent) is about six times as great as the aver age routine total coliform-positive rate (3.1 percent) for these systems. The ratio of repeat to routine total co liform-positive rates is greater for some sets of systems and smaller for others, but a ratio of at least six to one is common. Similar ratios of repeat to routine monitoring total coliform-positive rates were found for disinfected systems (ground wate r and surface water systems). Exhibit III-2 shows maximum likelihood distribut ions for the positive ra tes in routine and repeat samples of small TNCWSs (serving 100 people or fewer) servi ng undisinfected ground water. The vertical axis shows cumulative probability, which is the fraction of systems having at most the corresponding horizontal axis value. Co rresponding to 0.5 on the vertical axis is the median probability of a total coliform-positive. For example, for half of the systems, the probability of getting a total coliform-positive is 1.3 percent (i.e., 0.013 probability of total coliform-positive on horizontal axis) for routine samples. This is the median probability of total coliform-positive in routine samples. For repeat samples, the median probability of a positive is 17.5 percent (i.e., 0.175 probability of total colifor m-positive on horizontal axis), which is about 13 times greater than that of the routine samples.
Exhibit III-2 Maximum Likelihood Distribution for TNCWS Serving Undisinfected GW to <101 PeopleDocument initiating EO 12866 review

54 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9

1

Routine Samples Repeat Samples Median(Routines) = 1.3% Median(Repeats) = 17.5% Probability of Total Coliform PositiveCumulative Probability

ii. Frequency of repeat samples. The advisory committee recommended that the current TCR requirement for systems serving more than 1,000 people to take three repeat samples subsequent to a routine total coliform-positive be retained. The advisory committee recommended that systems serving 1,000 or fewer pe ople also be required to take three repeat samples rather than the four required under the current TCR. This view is supported by analysis of repeat sample records from the Six-Year Review 2 data. Repeat sampling helps utility operators to better understand the extent and duration of potential pathways of contamination into the di stribution system. The Si x-Year Review 2 data show that the average percenta ge of samples that are positiv e among repeat samples is much higher than that of routine samples, demonstra ting that when operators are required to take aDocument initiating EO 12866 review

55 second look at their systems following the posi tive routine sample, they find, on average, a higher rate of coliform presence th an during routine sampling. In other words, the high repeat total coliform-positive rate indicates the persisten ce of total coliforms at such locations in the distribution system. Further analysis of the data shows that for all PWSs serving 1,000 or fewer people, two or more of the repeat samples are positive in 75 percent of those instances in which there are any positive repeat samples, as shown in Exhibit III-3. For those 75 percent of instances, reducing the number of repeat samples from four to thr ee would have no effect on the number of systems that would be triggered to conduct an assessmen t of the system under the proposed RTCR. In these cases, at least one of the remaining repeat samples would still be total coliform-positive, and only one positive repeat sample is re quired to trigger an assessment. The data show that one repeat sample is posi tive in 25 percent of the instances in which any of the four repeat samples is positive. For these instances, EPA estimates that if only three repeat samples had been taken instead of four, three out of four (or 75 percent) of these positive samples would still have been encountered. Exhibit III-3 Percentage of instances with 1 or >1 positive repeat samples among those instances in which ≥ 1 repeat samples is positive Number of Positive Repeat Samples System Category 1 > 1 Undisinfected GWSs Serving ≤ 1000 23% 77% All PWSs Serving ≤ 1000 25% 75% Note: Analysis of Six-Year Review 2 data repeat sample records associated with months in which ≥ 50% of expected routine samples were taken (50% criterion). The total number of inst ances of positive repeat samples for undisinfected GWSs ≤ 1000 is 2953, while all PWSs ≤ 1000 have 3537 positive repeat samples. Source: Proposed RTCR EA Appendix H (USEPA 2009a)Document initiating EO 12866 review

56 When both of the two situations in which at least one repeat sample is positive (either one positive repeat sample or more than one positive repeat sample) are considered together, it is possible to estimate the overall e ffect of reducing the number of re peats from four to three, as presented in Exhibit III-4. The estimates in th e table indicate that if the number of required repeats were reduced from four to three, ther e would still be almost as many (approximately 94 percent) situations leading to an assessme nt being triggered for the system.
Exhibit III-4 Estimated Effects of Reducin g Number of Required Repeat Samples for PWSs Serving ≤ 1000 from 4 to 3

Percentage of events 1 with exactly 1 total coliform-positive (TC+) repeat sample Estimated percentage of events that would still have 1 TC+ if 1 out of 4 repeat samples were not taken Percentage of events 1 with >1 TC+ repeat sample Estimated overall percentage of events that would still have ≥ 1 TC+ repeat sample if 1 out of 4 repeat samples were not taken A B = A*0.75 C D = B+C Undisinfected GWSs Serving ≤ 1000 23% 18% 77% 94.2% All PWSs Serving ≤ 1000 25% 19% 75% 93.8% 1 Based on analysis of repeat sample reco rds associated with months in which ≥ 50% of expected routine samples were taken (50% criterion). The total number of events for undisinfected GWSs ≤ 1000 is 2953, while all PWSs ≤ 1000 have 3537 events. Source: Proposed RTCR EA Appendix H (USEPA 2009a)

Although dropping the required number of repeat samples from four to three means that some fraction of triggers may be missed, the other provisions of the proposed RTCR compensateDocument initiating EO 12866 review

57 for that change and, taken as a whole, the provisions of the proposed RTCR provide for greater protection of public health. One such provision includes enhanced consequences for monitoring violations. For example, systems that do not take all of their repeat samples under the proposed RTCR are triggered to conduct a Leve l 1 assessment. This permits an increase in public health protection over the current TCR because PWSs are required to assess their systems when monitoring results show that the PWS may be vulnerable to contam ination (indicated by a routine total coliform-positive sample). Moreover , because of the substantial cost of this potential consequence, systems would be more likel y to take all of their required repeat samples in the first place. It is important to point out that the major ity of systems in this category are ground water systems treating to less than 4-l og inactivation for viru ses (see Exhibit 4.1 of the Proposed RTCR EA (USEPA 2009a)). Because of the triggere d source monitoring provision under the GWR, these systems are required to collect a fecal indicator sample from the source water following a total coliform-positive sample in the distribution sy stem in addition to the repeat samples. Under the existing GWR and TCR, systems taking four re peat samples are permitted to take the fourth repeat sample at the source water if they measure for E. coli as the fecal indicator and if they have State approval. Under the proposed RTCR, systems would continue to take this source water sample to comply with the GWR in addition to three repeat samples in the distribution system to comply with the TCR. A positive samp le at the source that is not also considered a repeat sample would not trigger an assessmen t under the proposed RTCR, but it would provide diagnostic value to the system in addition to triggering additional requirements under the GWR (i.e., corrective action or five additional source water fecal indicator samples).Document initiating EO 12866 review

58 With State approval, ground water system s serving 1,000 or fewer people may use the sample taken at the location required for trigge red source monitoring to also meet the repeat monitoring requirements of the proposed RTCR. In this case, the State must also approve the use of E. coli as the fecal indicator under the GWR, and the system would comply with both GWR and the proposed RTCR when a total coliform-positive or E. coli -positive sample occurs. The advisory committee recommended this flexib ility to reduce the burd en on small groundwater systems that in most cases will have a very limited distribution system and only one source, consistent with the GWR. iii. Location of repeat samples. The advisory committee believed that requiring repeat samples to be taken within five service conne ctions up and downstream of the original total coliform-positive location can be difficult for syst ems to implement within the required 24 hours for a repeat sample because of issues such as access to the site. Therefore, the advisory committee recommended that systems be allowed to develop standard oper ating procedures as part of their sample siting plan to identify alternative monitoring sites and facilitate the identification of the source and extent of any problem. The advisory committee also recommended that ground water systems have the flexibility to propose repeat sampling locations that differen tiate potential source water and distribution system contamination (e.g., by sampling at entry poi nts to the distribution system). See section III.A.3 of this preamble for additional discussion on this topic.

c. Request for comment . EPA requests comment on the fo regoing proposed repeat sampling requirements. Specifically, EPA requests comment on the proposal to allow samples taken at the ground water source to serve both as a triggered source sample under the GW R and as one of the repeat samples under the proposed RTCR.Document initiating EO 12866 review

59 5. Treatment technique requirements

a. Provisions. i. Coliform treatment technique trigge rs. The non-acute MCL violation for total coliforms under the current TCR is effec tively replaced by a coliform treatment technique involving monitoring for total coliforms unde r the proposed RTCR. Under the proposed treatment technique framework, the presence of total coliforms is used as an indicator of the potential pathway of contamination into the dist ribution system. As discussed in section III.A.2 of this preamble, the proposed RTCR eliminat es the associated MC LG and MCL for total coliforms. The proposed revision specifies two le vels of treatment technique triggers, Level 1 and Level 2, and their correspond ing levels of response. Wh ether systems are required to conduct either a Level 1 or Leve l 2 assessment is based on the de gree of potential pathway for contamination. The proposed rule further lays ou t an additional trigger for a Level 1 assessment and defines Level 2 triggers that require a more in-depth examination of the system and its monitoring and opera tional practices. The system has exceeded the trigger immediately once any of the following conditions have been met: Level 1 treatment technique triggers

• For systems taking 40 or more samples per month, the PWS exceeds 5.0 percent total coliform-positive samples for the month; or

• For systems taking fewer than 40 samples pe r month, the PWS has two or more total coliform-positive samples in the same month; or

• The PWS fails to take every re quired repeat sample after any single routine total coliformpositive sample. Level 2 treatment technique triggersDocument initiating EO 12866 review

60 • The PWS has an E. coli MCL violation (see section III.A.6 of this preamble for description of what constitutes an E. coli MCL violation); or

• The PWS has a second Level 1 treatment techni que trigger within a rolling 12-month period, unless the first Level 1 treatment technique trigger was based on exceeding the allowable number of total coliform-positive samples, the State has determined a likely reason for the total coliform-positive samples that caused the initial Level 1 treatment technique trigger, and the State establishes that the sy stem has fully corrected the problem.

• For PWSs with approved reduced annual monito ring, a Level 1 treatment technique trigger in two consecutive years. ii. Assessment. EPA is proposing an assessmen t process in the RTCR to strengthen public health protection. Under the current TCR, a sy stem is not required to perform an assessment following a monthly/ non-acute MC L violation or an acute MCL violation. In contrast, the proposed RTCR requires systems to conduct assessm ents following the triggers specified above. EPA is proposing two levels of assessment based on the associated treatment technique trigger: Level 1 assessment for a Level 1 treatme nt technique trigger and Level 2 assessment for a Level 2 treatment technique trigger. At a minimum, both Level 1 and 2 assessments must include review and identificati on of the following elements:

• Inadequacies in sample sites, samp ling protocol, and sample processing,

• Atypical events that may affect distributed water quality or indicate that distributed water quality was impaired,

• Changes in distribution system maintenance a nd operation that may aff ect distributed water quality, including water storage,Document initiating EO 12866 review

61 • Source and treatment considerations that bear on distributed water quality, where appropriate, and

• Existing water quality monitoring data. EPA expects that States will tailor specific assess ment elements to the size and type of the system and that each public water system in turn will tailor its assessment activities based on the characteristics of its distribution system. Level 1 assessment A Level 1 assessment must be conducted when a PWS exceeds one or more of the Level 1 treatment technique triggers spec ified above. Under the proposed rule, this self-assessment shall consist of a basic examination of the source wate r, treatment, distribution system and relevant operational practices. The PWS might look at cond itions that could have occurred prior to and caused the total coliform-positive sample. Example conditions include treatment process interruptions, loss of pressure, maintenance and operation activ ities, recent operational changes, etc. In addition, the PWS might check the condi tions of the following elements: sample sites, distribution system, storage ta nks, source water, etc. The PWS must complete the Level 1 assessment as soon as practical afte r notification of its monitoring results or failure to take repeat samples. The PWS must submit the completed assessment form to the State for review within 30 days after determin ation that the PWS has exceeded the trigger. Failure to submit the co mpleted assessment form within 30 days is a reporting violation. If the State determines that the assessment is insufficient, the State will consult with the PWS. If necessary after consultation, th e PWS must submit a revised assessment to the State on an agreed upon schedule not to exceed 30 days from the date of the initial consultation.Document initiating EO 12866 review

62 In the completed assessment form, the PWS must identify assessments conducted, sanitary defects detected, corrective acti ons completed, and a timetable for any corrective actions not already completed. If no sanitary defects are f ound in an assessment, the assessor may note that no sanitary defects were identi fied. Upon completion and submi ssion of the assessment form by the PWS to the State, the State shall determine if the system has identified the likely cause(s) for the Level 1 treatment technique trigger and es tablish whether the syst em has corrected the problem(s).
Level 2 assessment A Level 2 assessment must be conducted when a PWS exceeds one or more of the Level 2 treatment technique trigge rs specified previously. A Level 2 assessment is a more comprehensiv e examination of the system, its monitoring and operational practices than th e Level 1 assessment. The level of effort and resources committed to undertaking a Level 2 assessment will be commensurate with the more comprehensive investigation and review of ava ilable information, and engage additional parties and expertise relative to the Level 1 assessment (see Appendix Y of the AIP) (USEPA 2008c)
. Level 2 assessments must be conducted by a party approved by the State: the State itself, a third party, or the PWS where the system has staff or management with the required certification or qualifications specified by the State. If the PWS or a third part y conducts the Level 2 assessment, the PWS or third party must follow the State requirements for conducting the Level
2 assessment. The PWS must complete the Level 2 assessment as soon as practical after notification that the PWS has exceeded a Level 2 treatment tec hnique trigger. The PWS must submit the completed assessment form to the State for review within 30 days after determination that theDocument initiating EO 12866 review

63 PWS has exceeded the trigger. Failure to subm it the completed assessment form after the PWS properly conducts the assessment is a reporting vi olation. The State may direct expedited action or additional actions such as in the case of an E. coli MCL violation. If the State determines that the assessment is insufficient, the State will consult with th e PWS. If necessary after consultation, the PWS must submit a revised asse ssment to the State on an agreed upon schedule not to exceed 30 days from the date of the initial consultation. In the completed assessment form, the PWS must identify assessments conducted, sanitary defects detected, corrective acti ons completed, and a timetable for any corrective actions not already completed. If no sanitary defects are f ound in an assessment, the assessor may note that no sanitary defects were identi fied. Upon completion and submi ssion of the assessment form by the PWS to the State, the State shall determine if the system has identified the likely cause(s) for the Level 2 treatment technique trigger and, if so , establish that the sy stem has corrected the problem(s). iii. Corrective action. The current TCR does not re quire systems that have MCL violations to perform corrective actions. U nder this proposal, EPA is requir ing PWSs to correct sanitary defects found through either a Level 1 or Level 2 assessment. Ideally, systems will be able to correct any sanitary defects found in the assessment within 30 da ys and report that correction on the assessment form. When the correction of sanitary defects is not completed by the time the PWS submits the completed assessment form to th e State, the PWS must complete the corrective action(s) on a schedule determined by the State. This schedule may be developed in consultation with the PWS. The schedule must include when the corrective action will be completed and any necessary milestones and temporary public health protection measures. The PWS must notify the State when each scheduled corrective action is completed.Document initiating EO 12866 review

64 At any time during the assessment or correctiv e action phase, either the PWS or the State may request a consultation with the other entity to discuss and determine the appropriate actions to be taken. The system may consult with the State on all relevant step s that the system is considering to complete the corrective action, including the me thod of accomplishment, an appropriate timeframe, and other relevant information.
E. coli detection in the distributi on system indicates a public he alth hazard and can result in

an E. coli MCL violation. Under the proposed rule, when an E. coli MCL violation has occurred, the system must complete a Level 2 assessment and corrective action must be implemented as soon as practical. The Agency encourages systems to promptly find the source of E. coli and fix the problem before the completed assessm ent form is due to the State.
b. EPA’s rationale . i. Coliform treatment technique. The advisory committee indicated that the conditions leading to a monthly/non-acu te MCL under the current TCR should trigger an assessment under the RTCR for several reasons. Fi rst, the advisory committee recognized that presence of total coliform indicat es that potential presence of a pathway for contamination from external sources such as sour ce water or through a loss of distribution system integrity. The change to a coliform treatment t echnique construct that uses tota l coliforms as an indicator of distribution system integrity places the emphasis on systems to take more preventive actions to address problems. These actions would better protect public health than the additional monitoring with no correctiv e action that is required under the current TCR. To address the high and constant number of PWSs with violations over the y ears under the current TCR, the proposed changes would be more protective by requiring systems to co rrect deficiencies associated with the non-acute MCL (see Exhibit VI.1 in section VI.C.1 of this preamble). Second, the advisory committee indicated that the public notice associated with non-acuteDocument initiating EO 12866 review

65 violations is confusing because th e presence of total coliforms is not necessarily an indication of a potential public health threat; however, it is an indicator of a potential pathway for fecal contamination to enter into the distribution syst em. Under the treatment technique requirement, the presence of total coliforms (at the level equiva lent to a non-acute viol ation) indicates a need to assess whether a problem exists. When a sy stem fails to conduct the assessment, the system will then incur a violation and be required to issue public notification. Third, the occurrence of total coliforms in the context of the coliform treatment technique requirement continues to inform and further the original objectives of the TCR: to evaluate the effectiveness of treatment, determine the integrity of the distribution sy stem, and signal the possi ble presence of fecal contamination. Finally, total coliform presence i ndicates the potential presence of a pathway for contaminants from external sources such as sour ce water or through a loss of distribution system integrity. ii. Assessment. The proposed rule requires assessm ents to ensure that specific action is taken to identify whether potential pathways of contamination into the distribution sy stem exist. The advisory committee indicated that assessments are significant actions that protect public health. Under the current rule, when a syst em has a non-acute MCL violation and if any subsequent sampling did not detect total co liform, the problem may persist due to the intermittent nature of total coliform and rema in unaddressed. However, the absence of total coliform-positive samples subsequent to an initial positive finding is not a reliable indicator that a contamination pathway no longer exists. In cont rast, the proposed revisions would ensure that systems examine and assess the cause of the total coliform occurrence (that is equivalent to the current non-acute MCL level) and take any corrective action if necessary.Document initiating EO 12866 review

66 Under the proposed rule, the system will also be required to conduct an assessment if it fails to conduct repeat monitoring following an initial total coliform-positive sample result. As discussed in section III.A.4 of th is preamble, repeat monitoring is critical in identifying the extent, source, and characteristic s of fecal contamination in a timely manner. Since the revised rule proposes to eliminate addi tional routine monitoring for systems that monitor at least monthly and decrease the number of additiona l routine monitoring a nd repeat monitoring samples for the smallest systems, the need to con duct repeat monitoring is more crucial than ever in providing immediate and useful information n eeded to protect public health. The cost for collecting and analyz ing a repeat sample would be consider ably less than the cost for conducting a Level 1 assessment. EPA expects that system s will want to ensure that assessments are conducted only when potential problems may exist rath er than for failure to take repeat samples. The proposed rule specifies two different levels of assessments – Level 1 and Level 2 – to recognize that a higher level of effort to dia gnose a problem applies to situations of greater potential of public health concern such as repeated Level 1 triggers or an E. coli MCL violation. Level 2 assessments are conducted by a party approved by the State, which may be the PWS where it has staff or management with the certif ication or qualifications as determined by the State. The Level 2 assessments may also be co nducted by the State or a third party approved by the State. To make more transparent what the Level 1 a nd Level 2 assessments entail and to facilitate consistent implementation among St ates, the proposed rule specifi es minimum elements for these assessments. The advisory committee recommen ded that the minimum elements identified previously in this preamble be included in the Level 1 and Level 2 assessments to identify potential flaws in monitoring or specific pa thways of contaminati on. Although the proposedDocument initiating EO 12866 review

67 RTCR specifies the same minimum elements for both the Level 1 and Level 2 assessments, the Level 2 assessment involves a more in-depth examin ation of these elements compared to a Level 1 assessment. Specific examples of how the Leve l 2 assessments are more in-depth than Level 1 assessments may be found in Appe ndix X of the AIP (USEPA 2008c). EPA recognizes that not every assessment will id entify a sanitary defect or find a reason or cause for the presence of total coliforms. If no sanitary defect is identified, the system must document that fact in the completed assessment form and provide supporting evidence for this conclusion. EPA expects that only systems that adhere to proper procedures and standards set by the State are eligible to arrive at this de termination, and only afte r providing sufficient supporting evidence. The advisory committee recommended that the Level 1 and Level 2 assessments be conducted as soon as practical after the PWS recei ves notice that the system has exceeded the treatment technique trigger. The advisory committee also recommended that systems submit the completed assessment forms to the State within 30 days after determination that the PWS has exceeded the trigger. The rationale for the 30-day interval is to allow sufficient time for problem identification and potential re mediation of the problem in conjunction with the follow-up assessment, in most cases. To help States and PWSs conduct assessments , EPA intends to develop a draft assessment and corrective action guidance manual and to make it available for public comment prior to promulgation of the final rule and to finalize the guidance manual after the rule is finalized. iii. Corrective action. The advisory committee r ecognized that not every assessment will identify a sanitary defect. However, the advisory committee recommended that the RTCRDocument initiating EO 12866 review

68 require all sanitary defects be corrected by the system in a timely manner. The system, in consultation with the State as needed, identifies and determines the specific corrective action. Under the proposed rule, the State may allow the PWS additional time to conduct the corrective action if needed. EPA recognizes that some systems may not be able to fix sanitary defects before submitting the completed assessment form within the 30-day interval due to the extent and cost of the correctiv e action. In such situations, EPA encourages the State and PWS to work together to determine the appropriate schedule for corrective acti ons to be completed. The system must comply with the agreed upon schedule and notify the State when each scheduled corrective action is completed. Either the PWS or the State may request consultation with the other party to determine the appropriate actions to be taken. EPA is not re quiring this to be a mandatory consultation to provide ease of implementation for States. In many cases, consultation may not be necessary because the type of corrective act ion for the sanitary defect will be clear and can be fixed right away (for example, repla cement of a missing screen).

c. Request for comment . EPA requests comment on the: (1 ) proposed change from the nonacute MCL for total coliforms to a coliform treat ment technique requirement that uses total coliforms as an indicator of a pathway of contamination; (2) proposed requirement for systems to conduct an assessment following a tr igger condition; (3) proposed le vels of assessm ent required; and (4) proposed requirement for systems to correct all sanitary defects found during an assessment. In addition, EPA requests comment on how to ensure that a Level 2 assessment is more comprehensive than a Level 1 assessm ent (e.g., should a Level 2 assessment include additional elements such as asset management and capacity development?).
6. ViolationsDocument initiating EO 12866 review

69 a. Provisions. EPA is proposing to modify the definition of the existing MCL violation, establish a treatment technique violation, and revise the monito ring and reporting violations. EPA is proposing that public notice be required fo r each type of violatio n (see section III.A.7 of this preamble for detail information on public notification). i. E. coli MCL violation

. A violation of the E. coli MCL occurs when:

• a routine sample is total coliform-positive and one of its associated repeat samples is E. colipositive; or

• a routine sample is E. coli -positive and one of it s associated repeat samples is total coliformpositive; or

• a system fails to take all required repeat samp les following a routine sample that is positive for E. coli ; or

• a system fails to test for E. coli when any repeat sample tests positive for total coliforms. ii. Coliform treatment technique violation. A co liform treatment technique violation occurs when:

• a system fails to conduct a required assessment w ithin 30 days of notification of the system exceeding the trigger (see sect ion III.A.5 of this preamble for conditions under which monitoring results trigger a required assessment); or

• a system fails to correct any sanitary defect found through either a Le vel 1 or 2 assessment within 30 days (see also section III.A.6 of this preamble) or in accordance with State-derived schedule. There would be no treatment technique violation associated solely with a system exceeding one or more action triggers (Level 1 or Level 2 triggers).Document initiating EO 12866 review

70 iii. Monitoring violation. Under the current T CR, a monitoring violation occurs when a system fails to comply with the total colifor m monitoring requirements, including the sanitary survey requirement. Under the proposed RTCR, a monitoring violation occurs when a system fails to take every required rout ine or additional routine sample in a compliance period, or when it fails to test for E. coli following a routine sample that is total coliform-positive. In addition, if a system on quarterly monitori ng has a monitoring violation in two or more quarters, or if a system on annual monitori ng misses its annual monitoring, it must begin monthly monitoring until it meets criteria for le ss frequent monitoring. See section III.A.3 of this preamble for a detailed discussion on monitoring frequency. iv. Reporting violation. A reporting violation occurs when a system that properly conducts monitoring or an assessment fails to submit a monitoring report or a correctly completed assessment form by the required deadline. The PW S is responsible for reporting this information to the State regardless of any arrangement with a laboratory. A reporting violation also occurs when a system fails to notify the State following an E. coli -positive sample.
b. EPA’s rationale. To define violations, the advisorycommittee built upon the principles underlying the current TCR violations and cu rrent TCR public notifi cation and suggested changes to improve public health protection wher e they saw a specific need. This proposal specifies responses to different degrees of potenti al public health concern. As described in the next section on providing information and notific ation to the public, Tier 1, Tier 2, and Tier 3 public notices are required followi ng violations corresponding to the severity of each violation type. i. E. coli MCL violation. An E. coli MCL violation (which incl udes failure to take all required repeat samples following an E. coli -positive sample) creates concern of an immediateDocument initiating EO 12866 review

71 potential public health th reat. For this reason, an E. coli MCL violation is considered an acute violation requiring immediate res ponse by the system. Including an E. coli MCL violation condition for systems failing to collect al l repeat samples following an initial E. coli- positive sample enhances public health protection by preventing a system fr om incurring only a monitoring violation when there is an indication of fecal contamin ation. As discussed previously in section II.D of this preamble, the presence of E. coli indicates a pathway of fecal contamination and should be taken seriously. Systems need to follow up with repeat samples to characterize the extent and source of such contamination. Failure to take the required repeat samples following an initial E. coli- positive sample is not protective of public health and is a serious violation. ii. Coliform treatment technique violation. A co liform treatment technique violation occurs when a potential pathway of contamination in the distribution system is unexplored and/or uncorrected. Performing the Level 1 and 2 asse ssments and taking corrective action are essential aspects of compliance with the treatment technique. A system which neglects to perform the prescribed assessment or correc tive action is in violation of the proposed RTCR’s treatment technique requirements. iii. Monitoring violation and repor ting violation. Monitoring a nd reporting violations occur when a system fails to comply with the routine monitoring requirements or when a system fails to submit monitoring reports or completed asse ssment forms. EPA believes that monitoring violations and reporting violations need to be ad dressed so that a system is held accountable to take actions to reduce public health risk, including regular monitoring of water quality.

c. Request for comment. EPA requests comment on the propos ed violation determinations.
7. Providing notification and information to the publicDocument initiating EO 12866 review

72 a. Provisions. To correspond to the changes in the proposed revised rule, EPA is proposing some modifications to the public notice (PN) requiremen ts contained in 40 CFR part 141 subpart Q. Tier 1 PN is required for an E. coli MCL violation. Tier 2 PN is required for a treatment technique violation for failure to conduct assessments or corrective actions. Tier 3 PN is required for a monitoring violati on or a reporting violation. In the current TCR, if a system has an acute MCL violation which is based on the presence of fecal coliforms or E. coli, or which is based on the system’s fa ilure to test for fecal coliforms

or E. coli following a total coliform-positive repeat sample, the system is required to publish Tier 1 PN. Under the proposed RTCR, a system is required to publish Ti er 1 PN when it has exceeded the E. coli MCL violation (see section III.A.6 of this preamble for what constitutes an
E. coli MCL violation). In addition, the system will continue to be required to notify the State after learning of an E. coli -positive sample, as currently is required under the TCR. As mentioned earlier in section III.A.2 of this pr eamble, EPA is proposing to eliminate the MCL for fecal coliforms. Under the proposed rule, the standard health eff ects language, which is required to be included in all public notification actions, is modified to delete the reference to the fecal coliform MCL and fecal coliforms, and to includ e a reference to the assessments and corrective actions in the subpart Y coliform assessment violations. In the current TCR, a system is required to publish a Tier 2 PN when the system exceeds the non-acute MCL violation, which is based on total coliform presence. Under the proposed rule, a system is required to publish a Ti er 2 PN if the system violates the coliform treatment technique requirements. Also, EPA is proposing to modi fy the standard health effects language for coliform to emphasize the assessment and corrective action requirements of the proposed rule.Document initiating EO 12866 review

73 In the current TCR, a system is required to publish a Tier 3 PN when the system has a monitoring and reporting violation. In the proposed rule, the Tier 3 PN requirements are changed to incorporate the recommendation in the AIP that monitoring violations be considered separately from reporting violati ons under the proposed RTCR. Both types of violations require Tier 3 PN. Consumer confidence report (CCR) requirements are also modified. Health effects language for the CCR, which is identical to the health effects language re quired for PN, is updated in the same way as described for PN. In additi on, the proposed RTCR removes the CCR requirements that require the inclusion of tota l numbers of positive samples, or highest monthly percentage of positive samples for total coliforms as well as total number of positive samples for fecal coliforms. These provisions are replaced by requir ements to include the number of Level 1 and Level 2 assessments required and completed, the corrective actions required and completed, and the total number of positive samples for E. coli . Unchanged and consistent with existing provisions under the current T CR, a CWS may provide Tier 3 PN using the annual CCR.
b. EPA’s rationale . The proposed public notification re quirem ents are consistent with the AIP language as well as with the tier system de scribed in 40 CFR part 141 subpart Q. These changes are appropriate because some of the t ypes of violations in the proposed RTCR are different from the current TCR. The standard health effects language fo r the public notification is also revised as appropriat e given the changes to what c onstitutes a violation under the proposed RTCR.
The proposed Tier 1 PN requirement for an E. coli MCL violation is consistent with the current TCR. Tier 1 PN is required f or NPDW R violations and situa tions with significant potential to have serious adverse effects on human health as a result of short term exposure. TheDocument initiating EO 12866 review

74 existing Tier 1 PN requires public notice as soon as possible but no later than 24 hours after the system learns of the violation. Exposure to E. coli in drinking water can possibly result in serious, acute health effects, such as diarrhea, cramps, nausea, headaches, or other symptoms and possible greater health risks for infants, young children, some of the elderly, and people with severely compromised immune systems.
Tier 2 PN is required for all NP DWR violations and situations w ith potential to have serious adverse effects on human health no t requiring Tier 1 PN. The syst em must provide public notice as soon as practical, but no later than 30 days after the system learns of the violation. A treatment technique violation under the proposed RTCR meets these criteria because it is an indication that the public water system failed to conduct an assessment or complete corrective action following identification of sa nitary defects. Identification of a sanitary defect indicates that a problem may exist in the distribution syst em that has potential to cause public health

concern. Tier 3 PN is required for all other NPDWR violations and situ ations not included in Tier 1 or Tier 2. The existing Tier 3 PN requires a system to provide public notice no later than one year after the system learns of the violation or situation or be gins operating under a variance or exemption. Monitoring violations and reporting violations meet these criteria because, while they do represent a violation of the proposed RTCR, the risk to public hea lth is not as clearly linked as those that are Tier 1 or 2. Therefore, EPA believes that a public notice given at least annually fulfills the public’s right- to-know about these violations. Consumer confidence report requirements are updated to reflect the advisory committee’s recommendations that total coliforms be used as an indicator to start an evaluation process that, where necessary, will require the PWS to correct sanitary defects. EPA believes it is mostDocument initiating EO 12866 review

75 appropriate to inform the public about actions ta ken, in the form of assessments and corrective actions, since failure to conduct these activities le ad to treatment technique violations under the proposed RTCR. Because the proposed RTCR no longer includes the to tal coliform MCL but now includes a trigger, EPA believes that system s no longer need to report the number of total coliform-positive samples via the CCR, since that could cause confusion or inappropriate changes in behavior among consumers. In ad dition, the CCR requirements will also reflect the removal of fecal coliform provisions under the proposed RTCR.

c. Request for comment. EPA requests comment on whethe r the PN and CCR language revisions are consistent with th e provisions of the proposed RTCR that reflect the use of total coliforms as an indicator within a coliform tr eatment technique. Since EPA is not aware of health effects resulting solely from exposure to total coliforms, the proposed RTCR eliminates the public notification requirement for detecti on of total coliforms, but provides for public notification upon detection of E. coli , and for violation of the colif orm treatment technique. The Agency does request comment, however, on the loss of information to consumers resulting from elimination of public notification requirements following positive sample results for total coliforms. EPA also requests comment on whether the proposed RTCR should require special notice to the public of sanitary defects, in addition to the PN requirements, similar to the GWR special notice requirements. This would be c onsistent with current requirements for other regulations that limit pathogens in ground wa ter systems. Under 40 CFR 141.403(a)(7)(i), a CWS must inform the public of the significant defi ciency and/or fecal indicator-positive sample. The CWS must continue to inform the public annually until the significant deficiency is corrected or the fecal contamination in the ground water source has been determined by the State to be corrected. Under 40 CFR 141.403a)(7)(ii), an NCWS that receives notice from the State ofDocument initiating EO 12866 review

76 a significant deficiency must inform the public of any significant deficien cy that has not been corrected within 12 months of being notified by the St ate, or earlier if dir ected by the State. The NCWS must continue to inform the public annually until the si gnificant deficiency is corrected.
8. Reporting and recordkeeping requirements for systems

a. Provisions. i. Reporting. In addition to the existing general reporting requirements provided in 40 CFR 141.31, the prop osed RTCR requires a PWS to:

• notify the State no later than the end of the next business day after it learns of an E. coli

positive sample.

• report to the State an E. coli MCL violation no later than th e end of the next business day after learning of the violation. The PWS is al so required to notify the public according to the provisions laid out in 40 CFR part 141 subpart Q.

• report to the State a treatment technique violation no later than the end of the next business day after it learns of the violation. The PWS must also notify the public in accordance with 40 CFR part 141 subpart Q.

• report to the State monitoring violations with in ten days after the system discovers the violation, and notify the pub lic in accordance with 40 CFR part 141 subpart Q.

• notify the State when each scheduled correc tive action is completed for corrections not completed by the time of the submission of the assessment form. In addition, systems triggere d into conducting an assessmen t are required to submit the completed assessment form within 30 days af ter determination that the coliform treatment technique trigger has been exceeded (see sec tion III.A.3 of this preamble for additional discussion).Document initiating EO 12866 review

77 ii. Recordkeeping

. EPA is proposing to maintain the current TCR requirements regarding retention of sample results and records of decisions related to monitoring schedules found in 40 CFR 141.33, including provisions that address the new require ments of the proposed RTCR pertaining to reduced and increased monitoring, tr eatment technique, etc. In addition, systems are required to maintain on file for State review the assessment form or other available summary documentation of the sanitary defects and corr ective actions taken. Systems are required to maintain these documents for a period not less th an five years after completion of the assessment or corrective action.
b. EPA’s rationale. In the case of an E. coli -positive sample, the proposed RTCR maintains the current TCR requirement that systems must notify the State by the end of the day when they are notified of the E. coli -positive result or by the end of the next busin ess day if the State office is already closed. The advisory committee beli eved that this requirement is important to maintain because of the potential for imme diate public health risk associated with E. coli presence and the desire for States to consid er quickly whether addi tional actions might be appropriate. The same rationale applies to E. coli MCL violations. Since there are new requirements for conducti ng assessments and corrective actions, and new conditions for obtaining increased or reduce d monitoring provisions, the proposed rule includes reporting and recordkeeping requirements to facilitate tracking of Level 1 and Level 2 triggers and compliance with treatment techni que requirements. Systems are required to maintain these files no less than five years. Sin ce systems have to maintain these files no shorter than the maximum period allowed between san itary surveys (i.e., fi ve years; see 40 CFR 142.16(b)(3) and 40 CFR 142.16(o)(2)), States have th e opportunity to look at and review theseDocument initiating EO 12866 review

78 files during sanitary surveys and/or annual visits. The five year pe riod is also consistent with the recordkeeping requirements for microbi ological analyses under 40 CFR 141.33(a). The timeframe by which reporting and recordkeep ing are required under the proposed rule is consistent with EPA’s practice regarding repor ting and recordkeeping requirements in other regulations under SDWA.

c. Request for comment . EPA requests comment on whether the timeframe required for reporting and recordkeeping requ irements are appropriate.
9. Analytical methods

a. AIP-related method issues. i. Evaluation of currently-approved methods. The AIP contains several recommendations by the adviso ry committee regarding th e analytical methods approved under the proposed RTCR. The advisory committee noted that the methods currently approved under the current TCR have varying sensitivities and specificities, and recommended that “... the Agency evaluate a ll currently approved coliform analytical methods to determine whether these methods continue to be appr opriate for use in drinking water compliance monitoring” (USEPA 2008c, AIP p. 7). In the twenty years since the current T CR was promulgated, many methods have been developed and approved for use. Most of the approved methods that ar e used to support the current TCR were evaluated under EPA’s Alternate Test Procedure (ATP) process. Under this process, a proposed method is evaluated in co mparison to a reference method. A favorable comparison serves as the basis for subsequent approval of the method fo r use in regulatory compliance monitoring. The ATP evaluations are designed based on the ATP Microbiology Protocol (USEPA 2004), an EPA guidance document that outlines how th e evaluation study should be conducted. In theDocument initiating EO 12866 review

79 years the ATP program has been in place, the ATP guidance document has been revised several times. As a result of different protocols bei ng used over time, the current set of approved methods have not all been evaluated under identical conditions. In addition to the concerns expressed by the advisory committee that the approved methods may not be equivalent to each other, EPA notes that there have been additional concerns with some of the methods currently approved. This includes allegations that some of the approved methods may have been modified since approva l without EPA’s knowledge. EPA is also aware of reports of varying performance of some enzyme-based methods (Oldstadt et al. 2007; Fricker
et al. 2003). Lastly, EPA is aware of at least one circumstance wh ere the manufacturer of an approved method placed a “product hold” and recall on the medium af ter the product was reported to be experiencing reduced recovery of E. coli

. For these reasons, EPA believes that additiona l information may be needed regarding the performance of the currently approved methods in order to justify thei r continued approval. Among the options, EPA is considering a comp lete, side-by-side method evaluation study, whereby all the methods are compared to each ot her under identical conditions, according to the same protocol. EPA is considering an approach under whic h vendors of all curren tly approved methods would have the option of voluntar ily participating in an independent, third-party laboratory evaluation through EPA’s Environmental Technol ogy Verification (ETV) Program. The goal of the ETV Program is to provide independent, obj ective, and credible performance data for commercial-ready environmental technologies. Mo re information on this program is available on EPA's website at www.epa.gov/etv/index

.Document initiating EO 12866 review

80 Under the ETV approach, EPA anticipates that participating vendors would generally fund the majority of the cost of their method eval uation. Based on the resu lts of the ETV study, as documented in the verification report, EPA would judge the appropriateness of each analytical method and would determine which should continue to be approved for future monitoring. EPA would then make any changes to the analytic al methods approved under the RTCR through later rulemaking. If a vendor chooses not to participate in the ETV study, EPA would allow the vendor to propose, for EPA’s consideration, an equivalent alternative ap proach for method evaluation. EPA will determine whether the proposed approach will provide an independent, effective, and credible evaluation. EPA emphasizes that any alte rnative approach would need to be equivalent in scope and rigor to the ETV program. As with the ETV study, EPA would use the results from an alternative study to judge the appropriateness of each analytical method and would determine which methods warrant approval for future monitoring under this regulation. As described at EPA’s April 2009 stakeholde r meeting, the time required to plan and conduct a proper method evaluation, and to assess th e results, is such that EPA does not expect to be able to complete this effort and to take action on the method ev aluation in time for the results to be included in the final RTCR. In stead, and to the extent necessary, EPA would address the disapproval of any of the current methods, or re strictions on any methods, in independent regulatory actions. ii. Review of ATP protocol. Th e AIP further recommends that EPA “engage stakeholders in a technical dialogue in its re view of the Alternative Test Pr ocedure (ATP) microbial protocol for TC/ E. coli methods for drinking water to determine if the criteria for acceptance of methods are consistent with the intent and objectives of the TCR...” (USEPA 2008c, AIP p. 7). InDocument initiating EO 12866 review

81 response, EPA notes that the study plan devel oped for the re-evaluation of current methods (under an ETV or alternative approach) could se rve as a starting point for discussions with stakeholders regarding the basis for evaluating new methods. The study plan could be used as a model for a revised ATP protocol; lessons learne d from the re-evaluation could also inform EPA’s future assessment of new methods. iii. Approval of “24-hour” methods. The AIP also recommends that EPA “consider approving methods that allow th e timely (e.g. on the order of 24 hours) analytical results for E. coli and TC and that provide relatively concurre nt analyses, without si gnificantly sacrificing accuracy, precision and specificity ” (USEPA 2008c, AIP p. 7). EP A notes that many of the approved methods that may be used in complian ce with the proposed rule can be completed in approximately 24 hours. However, the methods that detect lactose fermentation include a confirmation step that involves transfer of a presumptively positive culture into a more inhibitory confirmation medium which serves to ensure the initial positive was correct. As a result of this confirmatory step, lactose fermentation methods can take up to 96 hours to obtain a result. The enzyme based methods do not require this confirma tion step, and their results can be obtained in a 24 to 48 hour time period. EPA is aware of some concerns that methods with a 24 hour incubation time may not be able to detect as many coliform bacteria as methods with a 48 hour incubation period. Since many of the coliform bacteria found in a distribu tion system are injured or stressed due to disinfection practices, and since injured/stressed organisms may take longer to detect than 24 hours, this concern is of interest to EPA. As part of, or in additi on to, the method evaluation previously described, EPA may ther efore further investigate the im pact of incubation time on the recovery of stressed/injured organisms in dri nking water using approved media. At this time,Document initiating EO 12866 review

82 EPA believes that it is premature to conclude that either enzyme -based or lactose-based methods are inherently preferable. As discussed during the adviso ry committee meetings, the anal ysis time of the analytical methods is just one aspect in the overall amount of time it takes before a PWS obtains sample results from the laboratory and subsequently collects repeat samp les. Factors that can impact how quickly the PWS receives notification of a po sitive result include whether the PWS uses an in-house laboratory or must ship the sample to a distant contract laboratory, and whether the sample results are reported via an electronic means or via traditional mail. In addition, the turnaround time for repeat sampling can be affected by such factors as the laboratory daily hours of operation. The current TCR specifies that re peat samples be collected within 24 hours, but States currently have the flexibility to extend this timeline. The current TCR does not contain provisions for how quickly the laboratory must notify the PWS when a positive result is obtained. This proposal does not change these provisions. iv. Elimination of fecal coliforms under the pr oposed RTCR. The AIP also contains a recommendation that EPA remove all provisions related to fecal colif orms under the proposed RTCR. Consistent with this recommendation, an d for the following reasons, EPA is proposing to eliminate all fecal coliform provisions in the RTCR. First, the fecal coliform group can contain bacter ia not associated with fecal contamination.
E. coli is the most prominent member of the f ecal coliform group. However, other coliform bacteria, such as thermotolerant strains of Klebsiella spp ., have been shown to occur in the fecal coliform group (Warren et al . 1978). These non- E. coli bacteria are often found in environmental sources (for example, soil, vege tation, water) and, therefor e, are not exclusively associated with feces. Due to the presence of these non-fecal bacteria, the fecal coliform groupDocument initiating EO 12866 review

83 may not always provide the public water system w ith meaningful data regarding the vulnerability of their distribution system to fecal contamination. Secondly, when the current TCR was developed, there were few E. coli methods available. Many public water systems were familiar with and preferred to use the fecal coliform methods. However, since the current TCR was promulgated, many E. coli methods have been developed and approved for use. EPA believes that mo st systems nationwide currently test for E. coli , while few test for fecal coliform bacteria. Since the methods used to test for E. coli have approximately the same cost as those used to test for fecal coliform bacteria, this proposed change is not expected to create an additional burden on PWSs. EPA is proposing to eliminate all analytical method provisions for fecal coliforms that are included in the current TCR. EPA proposes instead to allow testing only for E. coli following a total coliform-positive sample. This change will provide the water system with more meaningful information regarding potential fecal c ontamination of the distribution system. The current TCR specifies a number of analytical methods that can be used for compliance sample analysis (in 40 CFR 141.21(f)). Since fe cal coliform bacteria are not regulated contaminants under this proposed rule, the analyt ical methods for fecal coliforms are no longer applicable and are removed from the list of an alytical methods. All other methods used for compliance with the current TCR are maintained for compliance sample analysis under the proposed RTCR.

v. Request for comment on AIP-related method i ssues. EPA is requesting comment on the following RTCR analytical method issues related to recommendations from the TCRDSAC in its
AIP:

• The use of an ETV approach for a reevaluation of analytical methods.Document initiating EO 12866 review

84 • Whether the RTCR should include provisions to ensure a more expedited results notification process. The RTCR could, for example, include language requiring that PWSs arrange to be notified of a positive result by thei r laboratory within 24 hours.

• Whether the RTCR should require repeat samp les be taken within 24 hours of a total coliform-positive with no (or limited) exceptions.
b. Other method issues . In addition to addressing the recommendations of the advisory committee, EPA is proposing some minor technical changes related to anal ytical methods. Many of these changes document practices that are al ready followed by PWSs and laboratories, and are consistent with the Manual for the Certific ation of Laboratories Analyzing Drinking Water (referred to as the “Laborat ory Certification Manual”)(USE PA 2005), an EPA document that outlines method requirements and good laboratory pr actices for certified laboratories conducting drinking water compliance sample analyses. Some of these changes were brought to the atten tion of EPA by EPA Regions and States involved in the implementation of the drinki ng water certification pr ogram. Other minor changes have been proposed to make the analytical methods section of this regulation easier to understand and implement. Each proposed change is described as follows with a discussion of the rationale for the change. i. Holding time. The proposed RTCR continues to provide a 30-hour holding time limit for the samples collected in compliance with this regulation (40 CFR 141.21(f )(3)). However, EPA is proposing to change the defini tion for holding time from “the time from sample collection to initiation of analysis may not exceed 30 hours” to “the time from sample collection to initiation of test medium incubation may not exceed 30 hours.”Document initiating EO 12866 review

85 ii. Dechlorinating agent for sample preservati on of chlorinated water supplies. The proposed RTCR establishes the following provision: “If chlorinated water is to be analyzed, sufficient sodium thiosulfate (Na 2 S 2 O 3 ) must be added to the sample bottle before sterilization to neutralize any residual chlorine in the water samp le.” Dechlorination procedures are addressed in section 9060A.2 of Standard Methods for the Examina tion of Water and Wastewater (20 th and
21 st editions) (Clesceri et al. 1998; Eaton et al. 2005). iii. Filtration funnels. EPA is proposing to a dd the following footnote to the analytical methods table (§141.852) under the revised rule: All filtration series must begin with me mbrane filtration equipment that has been sterilized by autoclaving. Exposure of membrane filtration equipment to UV light is not adequate to ensure sterilizat ion. Subsequent to the initia l autoclaving, exposure of the filtration equipment to UV light may be used to sanitize the funnels between filtrations within a filtration series.

iv. Analytical methods table changes. EPA is proposing the following changes to the analytical methods table:

• The table is organized by methodology (e.g., lactose-fermentation methods vs. enzymesubstrate methods).

• E. coli methods are included in the table.

• 18 th and 19 th editions of Standard Methods for the Exami nation of Water and Wastewater are no longer approved and have been removed.

• The references to Standard Methods 9221A and 9222A are removed.

• The reference to Standard Methods 9221B is changed to 9221B.1, B.2

• The reference to Standard Methods 9221D is changed to 9221D.1, D.2.

• The table proposes to allow Standard Methods 9221D in the multiple tube format as described in Standard Methods 9221B.Document initiating EO 12866 review

86 • The citation for MI agar is changed to EPA Method 1604 for clarity and consistency.

• The table clarifies that Sta ndard Methods 9221 F.1 and 9222 G.1 a (1), (2) may be used for E. coli analysis.

• The table clarifies the correct formulation fo r EC-MUG broth, when used in conjunction with Standard Methods 9222G.1 a (2), through the addition of the following footnote: The following changes must be made to the EC broth with MUG (EC-MUG) formulation: Potassi um dihydrogen phosphate, KH 2 PO 4 must be 1.5g and 4- methylumbelliferyl-Beta-D-glucuronide must be 0.05 g.

• The table reflects the approval of a modified Colitag method for the simultaneous detection of E. coli and other total coliforms.

v. EPA’s rationale for proposed change s related to other method issues. (a). Holding time. The current rule states “The time from sample collection to initiati on of analysis may not exceed 30 hours” (40 CFR 141.21 (f)(3)). Since prom ulgation of the current TCR, some States and EPA Regions have commented that “initiation of analysis ” may be interpreted several different ways, which can lead to the sample be ing held longer than the 30 hours intended by the rule. The proposed language more clearly defi nes the amount of time that the sample may be held and is consistent with section 6.4.1 of the Manual for the Certification of Laboratories Analyzing Drinking Water which states: “For the analysis of total coliform in drinking water, the time between sample collection and the placement of sample in the incubator must not exceed 30 hours.” EPA believes that changing the definition of holding time from “the time from sample collection to initiation of analysis” to “the time from sample collection to initiation of test medium incubation” may slightly decrease the am ount of time a PWS has to get the sample to a laboratory. EPA does not believe that this chan ge will significantly reduc e the amount of time aDocument initiating EO 12866 review

87 water system has to get a sample to the laborat ory, as most of the methods approved under this rule require 30 minutes or less to process and prepare the sample for the incubation step. Thus, the initial analytical steps should not constitute a large por tion of the holding time as a whole. EPA recommends that PWSs that have difficult y meeting the holding time notify the laboratory that the samples are in transit and need to be gi ven priority. The laborat ory could begin analysis immediately upon sample arrival so that the sample s could be placed in the incubator in time to meet the 30 hour holding time. EPA notes th at a laboratory may have to make specific accommodations in their processes in order to prop erly analyze a sample received close to the end of the holding time. EPA believes that this is feasible with proper planning. (b). Dechlorinating agent for sample pres ervation of chlorinated water supplies . Under this proposal, EPA would require that ch lorinated water samples be coll ected in bottles that contain the dechlorinating agent sodium thiosulfate. This is consistent w ith section 3.15.4 of the Laboratory Certification Manual, which states “If chlorinated water is to be analyzed, sufficient sodium thiosulfate (Na 2 S 2 O 3 ) must be added to the sample bottle before sterilization to neutralize any residual chlorine in the wate r sample.” Neutralization ceases the bactericidal action of the chlorine during sample transit, thus allowing a more accurate assessment of what the true microbial content of the water sample was at th e time of sample collec tion. Implementation of this new requirement should be straightforward si nce PWSs need only ask the laboratory for pretreated sample containers. EPA does not believe th is provision will cause an increase in cost to PWSs, as the cost of the bottles w ith the sodium thiosulfate is esse ntially the same as the cost of the bottles without the sodium thiosulfate. (c). Filtration funnels . Under this proposal, EPA is requiring that membrane filtration equipment be autoclaved before beginning a filtrati on series. This requirement is consistent withDocument initiating EO 12866 review

88 section 4.1.3 of the Laboratory Certification Manual, which states : “Membrane filter equipment must be autoclaved before the beginning of a filtration series.” Under the current TCR, not all of the approve d membrane filtration methods require that a filtration series begin with membrane filtration units that have been sterilized by autoclave. Some of the approved methods allow the laboratory to use ultraviolet (UV) radiation exposure in lieu of autoclaving to sterilize filtration units be tween filtration series. EPA does not believe that ultraviolet radiation is sufficient to properly sterilize the membrane filtration equipment. Additionally, EPA believes that when ultraviolet ra diation is used, not all areas of the membrane filtration equipment are exposed, and therefor e microorganisms may persist and contaminate other water samples and the laboratory. For these reasons, EPA is proposing to include a footnote to the analytical methods table in order to ensure proper sterilization. EPA does, however, believe that ultraviolet li ght can be used to sanitize the filtration equipment between filtrations w ithin a filtration series, as stated in section 4.1.4 of the Laboratory Certification Manual: “Ultraviolet light (254 nm) may be used to sanitize equipment (after initial autoclaving for ster ilization), if all supplies are pre- sterilized. Ultraviolet light may be used to reduce bacterial carry-over between samples during a filtration series.” (d). Analytical methods table. In this proposal, EPA is iden tifying a number of changes to the analytical methods table for clarity and accuracy. In the current TCR, the methods are listed by date approved and the E. coli methods are listed in a text format. In this proposal, the analytical methods table is organized by methodology (e.g., lactose-fermentation methods vs. enzyme-substrate methods), and the E. coli methods are included in the table.Document initiating EO 12866 review

89 Standard Methods for the Exami nation of Water and Wastewater is a reference document designed to represent “the best current practice of American wate r analysts." Periodically, new editions are published in order to incorporate improvements in the methods contained within this manual. Thus, new editions of this publicati on contain more current and improved versions of the methods. Under the current TCR, four editions of this publication are approved, resulting in different, oftentimes outdated, versions of th e same method being approved. Having multiple editions of this manual approved under this re gulation also creates a burden for the laboratory certification officers who must unde rstand the differences between the versions of the method for which the laboratory may be seeking certificatio n. For these reasons, EPA is proposing to remove the 18 th and 19 th editions of Standard Methods for the Ex amination of Water and
Wastewater for use in compliance sample analysis under the RTCR. EPA expects that the burden associated with this change will be mini mal as most laboratories have already procured the newer editions or have arranged fo r access to the onlin e publication. In this proposed regulation, the referen ce to Standard Methods 9221A and 9222A are removed. These sections of the methods contai n only introductory information, not any actual methodology. They do not represent methods approved for use under this regulation. The references to Standard Methods 9221B and 9221D are modified in this proposed regulation. In the current TCR, the methods ar e referenced as 9221B and 9221D with footnote 5 denoting that the “completed phase” called for in the methods is not required. By more specifically citing Standard Methods 9221 B.1, B.2, and 9221 D.1, D.2 (which contain the applicable, required steps of these methods) EPA is able to eliminate the original footnote and improve clarity.Document initiating EO 12866 review

90 EPA is proposing to allow Standard Methods 9221D (Presence-Absence broth) to be used in a multiple tube format. This method has traditionally been used in a single bottle, allowing only the qualitative detection of total coliforms. However, ther e are published reports showing this method can be used in a multiple tube format fo r the quantitative detection of total coliforms (Rice et al. 1987; Rice et al. 1993). This medium would be used in the same manner that Lauryl Tryptose Broth (LTB) is described as being used in Standard Methods 9221B. Allowing the use of this method in a multiple tube format would allow PWSs that use this method to quantitate any total coliforms that may occur in the water sample. EPA is proposing to change the citation for MI Agar. Under the current TCR, this method is cited as Standard Methods 9222, with a footnote citing the Applied and Environmental Microbiology article where the method was initially desc ribed. In this proposal, the method is now cited as EPA Method 1604, consistent with section 5.4.2.1.3 of the La boratory Certification Manual. EPA Method 1604 is identical to the citati on in the TCR and does not require the use of the original footnote. This change is also consistent with the c itation of this method as listed in the Ground Water Rule (see 40 CFR 141.402). The current TCR describes the use of “EC medium supplemented with 50 g/mL of 4- methylumbelliferyl-Beta-D-glucuronide (MUG) ” (see 40 CFR 141.21(f)(6)(i)). This proposal clarifies that this medium, included in both Standard Meth ods 9221F and Standard Methods
9222G.1 a (2), is approved for use under this regulation. This is consistent with the Laboratory Certification Manual, particul arly section 5.1.8, which describes both of these methods as approved for use in the detection of E. coli under this regulation. Lastly, EPA is clarifying the formulation for EC broth with MUG (EC-MUG) given in Standard Methods 9222G.1 a (2) to correct an error in the publication. The Standard MethodsDocument initiating EO 12866 review

91 9222G.1 a (2) formulation calls for 0.1 g of 4-met hylumbelliferyl-Beta-D-glucuronide, and 1.4g
KH 2 PO 4. This formulation differs from that given in Standard Methods 9221F.1, which calls for 0.05 g and 1.5 g, respectively. EPA believes that th e correct formulation is given in Standard Methods 9221F and has confirmed this with St andard Methods committee members (Rice 2009). Accordingly, EPA has added a footnote to the 9222G.1 a (2) stating the proper formulation. EPA anticipates that these changes to the analytical methods table will not cause any additional burden to the PWSs. vi. Request for comment regarding holding temp erature. The current TCR states the following regarding sample shipment: “Systems are encouraged but not required to hold samples below 10 deg. C during transit.” Othe r national primary drinking water regulations requiring microbial sampling require that the samples be shipped in cold conditions, and require the sample be maintained at a temperature of 10 degrees Celsius (C) or less. Maintaining the sample temperature below 10 degrees C serves to preserve the bacterial population by minimizing both bacterial cell death and cell multip lication, thus allowing for a more accurate representation of the microbial popu lation in the sample at the tim e of sample collection. Also, Standard Methods for Examination of Water and Wastewater, 21 st edition (Eaton et al. 2005) recommends that samples be shipped at less than 8 degrees C but not frozen. In the years since the promulga tion of the current TCR, EPA ha s heard concern that at times, samples collected under the TCR may reach high te mperatures during transit to the laboratory due to the lack of a requirement to ship sample s on ice. High temperatures that may be reached during transit could have a deleterious or prolif ic effect on the bacteria l cells present in the samples such that the samples may no longer repr esent the microbial conten t of the water at the time of sample collection.Document initiating EO 12866 review

92 EPA recognizes that requiring the samples under the proposed RTCR to be held at 10 degrees C or less, but above freezing, would result in an increased cost to the water systems (for shipping, supplies, etc.), but beli eves the extra burden may be wa rranted. EPA is seeking public comment on whether this passage should remain as is in the current TCR or whether the RTCR should require that the samples co llected for compliance with this regulation be shipped in cold conditions, i.e., requiring a temperature of 10 degrees C or less, but above freezing to be maintained for better sample preservation. EP A also welcomes comments and supporting data on what the acceptable temperature range should be when samples are in transit.
B. Proposed Compliance Date Consistent with SDWA section 1412(b)(10), EP A proposes that the compliance date of the final RTCR be three years from the date on wh ich the regulation is promulgated (i.e., the publication date of the final rule in the Federal Register ). PWSs must comply with the requirements of the rule by the compliance date. EPA believes that capital improvements genera lly are not necessary to ensure compliance with the proposed RTCR. However, a State may allow individual systems up to two additional years to comply with the RTCR if the State determines that additional time is necessary for capital improvements, in accordance with SDWA section 1412(b)(10). EPA requests comment on the proposed compliance date of the proposed RTCR.
C. Links to Other Drinking Water Rule Requirements The proposed RTCR recognizes that existing NPDWRs cont ain linkages among monitoring requirements in different rules. The current re sidual disinfectant monitoring must be conducted at the same time and location at which TCR samp les are taken, as provided for in the Surface Water Treatment Rule (SWTR) (USEPA 1989b, 54 FR 27486, June 29, 1989) and the Stage 1Document initiating EO 12866 review

93 Disinfectants and Disinfection Byproducts Ru le (Stage 1 DBPR) (USEPA 1998a, 63 FR 69389, December 16, 1998). Under the GWR, TCR distri bution system monitoring results determine whether a system is required to conduct s ource water monitoring. Under the SWTR, high measurements of turbidity in an unfiltered subpart H system trigger additional total coliform samples. Sanitary survey provisions exist in surface water and ground water drinking water regulations. The proposed RTCR do es not change the existing sanitary survey requirements except to add the special monito ring evaluation that States mu st conduct at systems serving 4,100 or fewer people. These evaluations do not increase the burden to co nduct sanitary surveys because of the relatively simple nature of these systems and their monitoring requirements.
1. SWTR, Stage 1 and Stage 2 DBPRs, ADWR After considering the possibl e linkages among the proposed RTCR and the SWTR, Stage 1 DBPR, Stage 2 DBPR (USEPA 2006e, 71 FR 388, January 4, 2006), and Airline Drinking Water Rule (ADWR) (USEPA 2009e), EPA has concluded that the only nece ssary revision is to update the reference to the current TCR at 40 CFR 141.21, which is superseded by 40 CFR part 141 subpart Y beginning three years following publicati on of the final rule. EPA is also proposing several revisions to other NPDWRs, discussed belo w, that are not necessary but would facilitate implementation of all applicable NPDWRs.
2. GWR As with the other drinking water rules men tioned above, EPA is proposing to update the references in the GWR to the current TCR at 40 CFR 141.21, which will be superseded by 40 CFR part 141 subpart Y. In addition, EPA is pr oposing to revise portions of the GWR triggered source monitoring requirements that allow for a samp le taken at the ground water source to alsoDocument initiating EO 12866 review

94 qualify as a repeat sample under the current T CR. The discussion on repeat samples can be found in section III.A .4 of this preamble.
3. Sanitary surveys Sanitary survey requirements are not included in the proposed RTCR. Under the current TCR, community water systems and non-commun ity water systems that serve 4,100 or fewer people are required to conduct period ic sanitary surveys. Since the promulgation of the TCR in 1989, new sanitary survey requirements for surface water systems and ground water systems have been established for all system sizes a nd types under the Interim Enhanced Surface Water Treatment Rule (IESWTR) (USEPA 1998b, 63 FR 69477, December 16, 1998) (40 CFR 142.16(b)(3)), and the Ground Water Rule (GWR ) (40 CFR 142.16(o)(2)(i)). Public water systems began implementing the IESWTR sanitarysurvey requirements in 2001. Therefore, for surface water systems, the current TCR sanitary su rvey requirements have phased out since that time. Implementation of the GWR sanitary su rvey requirements begin in December 2009 for ground water systems. Therefore, for ground water systems, the GWR sanitary survey requirements will be in effect by the time the RTCR is finalized.
D. Best Available Technology (BAT)
1. Provisions The proposed RTCR would maintain the provisio ns set forth in 40 CFR 141.63(d) (proposed to be in §141.63(e)), regarding the best tec hnology, treatment techniques, or other means available for achieving compliance with the MCL of either total coliforms or E. coli . EPA is proposing the following modifications:

• 40 CFR 141.63(d)(1) (proposed §141.63(e)(1)) woul d be modified by replacing “coliforms” with “fecal contaminants.”Document initiating EO 12866 review

95 • 40 CFR 141.63(d)(3) (proposed §141.63(e)(3)) w ould be modified by including “cross connection control” in the list of proper maintenance practices for the distribution system.

• 40 CFR 141.63(d)(4) (proposed §141.63(e)(4)) would be modified by including the subparts P, T, and W that describe f iltration and/or disinfection of surface water, and subpart S for disinfection of ground water.
2. EPA’s rationale

a. Change “coliform” to “fecal contaminants.” This change reflects the approach of the proposed RTCR that the presence of total colifor ms does not necessarily have a direct public health implication. Instead, tota l coliform is used as an indicator of a potential pathway of contamination within a treatment technique requirement. For additional discussion on this topic, see section III.A.2 of this preamble.
b. Inclusion of cross connection control . EPA believes that adding cross connection control to the list of proper maintenance practices for di stribution systems is appropriate because of the significant contribution of cross connections and backflow to waterborne disease outbreaks. From 1981 to 1998, the CDC documented 9, 734 detected and reported illnesses from 57 waterborne outbreaks related to cross c onnections (NRC 2006). From 1970 to 2001, approximately 12,000 illnesses resulted from 459 incidents of wate rborne outbreaks from backflow events (NRC 2006).

c. Addition of other relevant subparts of 141 . This change adds references to subparts that contain provisions for the other drinking water rules promulgated since 1989 when the TCR was promulgated (in particular, subpart P for the IE SWTR, subpart S for the GWR, subpart T for the Long Term Enhanced Surface Water Treatm ent Rule (USEPA 2002, 67 FR 1812, January 14, 2002, and subpart W for the Long Term 2 Enhanc ed Surface Water Treatment Rule (USEPADocument initiating EO 12866 review

96 2006d, 71 FR 654, January 5, 2006)). These drinking water rules contain updated filtration and disinfection standards that were not part of the current TCR when it was promulgated in 1989.
3. Request for comment EPA requests comment on the modifications to the existing BATs and whether there is a need to add or otherwise update the list of BATs.
E. Variances and Exemptions
1. Provisions EPA is proposing to not allow va riances or exemptions to the E. coli MCL. EPA is also proposing to eliminate the vari ance provisions in 40 CFR 141.4( b) that allow systems to demonstrate to the State that the violation of th e monthly/non-acute total coliform MCL is due to biofilm and not fecal or pathogenic contamination. This change will also result in a parallel change in 40 CFR 142.63(b).
2. EPA’s rationale Under the proposed RTCR, E. coli is used as an indicator of fecal contamination that may contain waterborne pathogens. To the exte nt a variance or exemption would permit the continued presence of E. coli , the potential for pathogens to be present also would remain. EPA believes that water which exceeds the MCL for E. coli poses an unreasonable risk to public health. Therefore, EPA is not allowi ng any variances or exemptions to the E. coli MCL. This provision is consistent with th e existing requirement, since the provision that allows variances applies only to the monthly/non-acute total coliform MCL violation and not to the acute violation associated with the presence of E. coli

. Under the current TCR, EPA allows variances to the MCL for total coliforms when a system has demonstrated to the State that the violation of the total coliform MCL is due to a persistentDocument initiating EO 12866 review

97 growth of total coliforms in the distribution system (i.e., biofilm) rather than fecal or pathogenic contamination, a treatment lapse or deficiency, or a problem in the operation or maintenance of the distribution system. EPA is proposing to eliminate the variance in 40 CFR 141.4(b) because under the proposed RTCR, there would no longer be an MCL for to tal coliforms (see section III.A.2 of this preamble). The current TCR MCL for total colifor ms was based on the presence or absence of total coliforms in a sample (see 40 CFR 141.63 for details). In the proposed RTCR, the presence of total coliforms at a certain level requires th e system to comply with the coliform treatment technique requirements (see secti on III.A.5 of this preamble). The assessment and corrective action requirements under this proposed rule includ e the possibility of re cognizing that the total coliform presence is associated w ith biofilm. EPA plans to include this information in a new assessment and corrective action guidance manual related to the RTCR.
3. Request for comment EPA requests comment on its proposal to allow no variance or exemption to the E. coli MCL and to eliminate the variance provisions associated with the monthly/non-acute total coliform MCL.
F. Request for Comment on Other Issu es Related to the Proposed RTCR
1. Consistency between the proposed RTCR and the GWR EPA requests comment on the need for general consistency between the proposed RTCR and the GWR. Please provide specific examples . For example, under the current TCR, States are required to keep records of their decision to either waiv e or extend the 24-hour limit for collecting samples (that is, for repeat samples following a total coliform-positive sample, or for follow-up samples after high levels of tu rbidity) (see 40 CFR 142.14(a)(5)(i)(A) andDocument initiating EO 12866 review

98 142.14(a)(5)(ii)(D)). The proposed RT CR also requires States to keep records of decisions to either waive or extend the 24-hour limit for re peat samples following a total coliform-positive sample, for samples following invalidation, or for follow-up samples after high levels of turbidity (see §§142.14(a)(10)(i)(A ) and 142.14(a)(10)(ii)(D ) of the proposed RTCR). Under the GWR, there are no recordkeeping requirements fo r the decision to waiv e or extend the 24-hour limit. Instead, the GWR includes special primacy requirement to describe criteria the State will use to extend the 24-hour limit (see 40 CF R 142.16(o)(3)(i)). EPA requests comment on whether it is appropriate to have States describe their criteria for waiving or extending the 24- hour limit as a primacy condition, or instead have States keep records of decisions to waive and/or extend the 24-hour limit.
2. Storage tank inspection and cleaning EPA requests comment on the value and cost of periodic storag e tank inspection and cleaning. There are instances of storage tanks being the source of waterborne disease outbreaks at PWSs. In December 1993, a Salmonella typhimurium outbreak in Gideon, Missouri resulted in over 600 people affected by diarrhea, 31 cases of laboratory-confirmed salmonellosis and seven deaths of nursing home re sidents who had exhibited diarrh eal illness (four deaths were confirmed by culture). The larger of the two st orage tanks had a breach in the roof hatch that allowed pigeon droppings to be carried into the tank and likely accumulated in the several inches of sediment. This contaminated sediment, mo re than likely, was pulled into the distribution system by a flushing program that drained the tank (Clark et al. 1996). Salmonella typhimurium was isolated from the sediment of one of th e towers, and tap water tested positive for fecal coliforms (CDC 1996).Document initiating EO 12866 review

99 In March 2008, Alamosa, Colorado (with a population of about 9,000 people) experienced a waterborne disease outbreak associated with Salmonella . The report releas ed by the Colorado Department of Public Health and Environment (Falco and Williams 2009) indicated that the outbreak resulted in 442 reported cases of illnesses, 122 of which were laboratory confirmed, and one fatality. The State epidemiologist estimated that a total of 1,300 people may have been ill. Two storage tanks in Alamosa had several in ches of sediment and breaches; one tank had breaches large enough for birds and animals to enter Some of the key factors that contributed to these two outbreaks include signifi cant levels of sediment (several inches to feet) and the presence of breaches of the integrity of the storage tank. Sediment accumulation occurs within storage facilities due to quiescent conditions which promote particle setting. Over time sediment c ontinues to accumulate in a tank, even if the finished water is consistently treated to below 0.1 nephelometric turbidity unit (NTU). For surface water systems, it is not uncommon to have 1⁄4 to 1⁄2 inch or more of sediment accumulate after two to three years (Kirmeyer et al . 1999). While there are no turbidity regulations for ground water systems (except for ground water unde r the direct influence of surface water (GWUDI)), the levels of turbidity can be significa nt in the water pumped from an aquifer. Sand particles, if allowed to accumu late, provide pore spaces that h ouse diverse populations of biota (which may include pathogenic microorganisms) (Kirmeyer et al. 1999; van der Kooij 2003). Periodic high flows in the storage tank may scour , stir up, and suspend the sediment (along with entrapped bacteria and pathogens) and carry it into the distribution system, with greater accumulation of sediment being a more signific ant concern. Other water quality problems associated with sediment accumulation include increased disinfectant demand and disinfection byproduct formation.Document initiating EO 12866 review

100 The storage tank’s vulnerability to contamina tion increases when breaches of the storage tank allow insects, animals, and birds and their asso ciated diseases to enter. Contamination from bird and other animal excrement can potential ly transmit disease-causing organisms to the finished water. Waterfowl, for example, ar e known carriers of many different waterborne pathogens including Vibrio cholerae (Ogg et al . 1989). Based on the potential public health implicatio ns associated with poorly maintained storage tanks (e.g., as indicated by signi ficant sediment accumulation and breaches), EPA is interested in receiving comments and supporting information rega rding the state and condition of tanks that have been cleaned and inspected, costs of st orage tank inspection and cleaning, and how public health can be better protected. EPA requests information on whether there are States that recommend or require periodic inspection and cl eaning of storage tanks. If so, what are the requirements, the frequency of inspection a nd cleaning, and how successful are they? Are inspections and cleaning done by indivi dual PWSs or by contractors?
3. States under EPA direct implementation EPA does not have the authorities provided to other primacy agencies under 40 CFR part 142 to use in implementing rules in direct im plementation entities (e.g., Tribal systems and Wyoming). To provide EPA the flexibility of other primacy agencies to modify monitoring requirements as necessary to protect public health (e.g., to require more stringent monitoring or to develop criteria such as those that pr imacy States develop under the special primacy conditions requirement in 40 CFR 142.16) and facilitate implementa tion of this rule. EPA is requesting comment on whether the Agency shoul d have the same authorities specified in subpart Y, as States have in 40 CFR 142.16, fo r PWSs for which the Agency has directDocument initiating EO 12866 review

101 implementation responsibilities. EPA is requesti ng comment on whether this authority should be added to subpart Y specifically.
G. Limitations to the Public Co mment on the Proposed RTCR The proposed revisions to other drinking wate r regulations (SWTR, Stage 1 DBPR, Stage 2 DBPR, and ADWR) are made solely to update the reference to the current TCR at 40 CFR 141.21, which will be superseded by 40 CFR part 141 subpart Y beginning three years following publication of the final rule. This proposed rule would not change any substantive requirements of those rules and EPA is not soliciting public comments on those rules ot her than their proposed revised references to the current TCR or any other references to the current TCR that EPA may need to revise.
IV. State Implementation The proposed RTCR provides States with flexib ility to implement the requirements of the rule in a manner that maximizes the efficiency of the rule for the States and water systems while increasing the effectiveness of the rule to protec t public health. While the proposed rule provides some reduction in monitoring relative to the curr ent TCR, overall, the proposed rule is more stringent and better protect s public health. As a result, States must adopt these revisions, when final, or adopt or maintain more stringent requirements, in order to maintain primacy. This section describes the regulations and other procedures a nd policies States must adopt in order to obtain primacy to implement the RTCR, if finalized as proposed today. SDWA section 1413 establishes requir ements that States or eligib le Indian Tribes must meet to assume and maintain primary enforcement responsibility (primacy) for its PWSs. These requirements include:Document initiating EO 12866 review

102 • Adopting drinking water regulati ons that are no less stringent than Federal drinking water regulations;

• Adopting and implementing adequate procedures for enforcement;

• Keeping records and making reports available on activities that EPA re quires by regulation;

• Issuing variances and exemptions (if allowed by the State), under conditions no less stringent than allowed under SDWA; and

• Adopting and being capable of implementing an adequate plan for the provisions of safe drinking water under emer gency situations. States may adopt more stringent requirements (e.g., requiring all systems to conduct routine monthly monitoring). Many States have used this authority in the past to improve public health protection and/or simplify implementation. Section 1413(a)(1) of SDWA provides two y ears (plus up to two more years if the Administrator approves) after promulgation of the final RTCR for the State to adopt corresponding drinking water regulations in orde r to obtain primacy for the final RTCR. To implement the final RTCR, States would be require d to adopt or maintain requirements that are at least as stringent as the follo wing revisions to 41 CFR part 141:

• Section 141.4 - Variances and exemp tions (if allowed by the State).

• Section 141.21 - Coliform sampling.

• Section 141.52 - Maximum contaminant level goals for microbiological contaminants.

• Section 141.63 - Maximum contaminant levels (MCLs) for microbiological contaminants.

• Section 141.74 - Analytical and monitoring requirements.

• Section 141.132 - Monitoring requirements.

• Subpart 141.153 - Content of the reports.Document initiating EO 12866 review

103 • Subpart 141.202 - Tier 1 Public Notice – Form, manner, and frequency of notice.

• Subpart 141.203 - Tier 2 Public Notice – Form, manner, and frequency of notice.

• Subpart 141.204 - Tier 3 Public Notice – Form, manner, and frequency of notice.

• Subpart O - Consumer Confidence Reports , Appendix A, Regulated Contaminants.

• Subpart Q - Public Notification of Dri nking Water Violations, Appendix A, NPDWR Violations and Other Situations.

• Subpart Q - Public Notification of Dri nking Water Violations, Appendix B, NPDWR Violations and Other Situations.

• Subpart Y - Revised Total Coliform Rule. EPA’s regulation at 40 CFR part 142 sets out the specific program implementation requirements for States to obtai n primacy for the public water supply supervision program as authorized under SDWA section 1413. In addition to adopting basic primacy requirements specified in 40 CFR part 142, St ates may be required to adopt special primacy provisions pertaining to specific regulati ons where implementation of th e rule involves activities beyond general primacy provisions. States must incl ude these regulation-speci fic provisions in their application for approval of their program revision. States must continue to meet all other conditions of primacy for all other rules in 40 CFR part 142. Primacy requirements for the proposed RTCR are described below. The advisory committee recognized that this rule will require more tracking to ensure effective implementation. Therefore, EPA plan s to release an upgrade to SDWIS/State and SDWIS/FED (the State and Federa l versions of the Safe Drinking Water Information System, respectively) within 18 months of final rule promulgation to accommodate monitoring data,Document initiating EO 12866 review

104 tracking, compliance determinati ons and reporting of all rule related requirements, as appropriate.
A. State Special Primacy Requirements To ensure that a State program includes all the elements necessary for an effective and enforceable program under the proposed RTCR, a State primacy application must include a description of how the Stat e will perform the following:

• Sample Siting Plans - States must describe the frequency and process used to review and revise sample siting plans in accordance with 40 CFR 141 subpart Y to determine adequacy.

• Reduced Monitoring Criteria – The primacy applic ation must indicate whether the State must adopt the reduced monitoring prov isions of subpart Y. If the State adopts the reduced monitoring provisions, it must describe the spec ific types or categories of water systems that will be covered by reduced monitoring and whether the State will use all or a reduced set of the optional criteria. For each of the redu ced monitoring criteria, both mandatory and optional, the State must describe how the cr iteria will be evaluated to determine when systems qualify.

• Assessments and Corrective Actions – States mu st describe their process to implement the new assessment and corrective action phase of the rule. The desc ription must include examples of sanitary defects, examples of a ssessment forms or formats, and methods that systems may use to consult with the State on appropriate corrective actions.

• Invalidation of routine and repeat samples colle cted under subpart Y – States must describe their criteria and process to invalidate total coliform-positive and E. coli- positive samples under subpart Y. This includes criteria to de termine if a sample was improperly processed by the laboratory, reflect s a domestic or other non-distribu tion system plumbing problem orDocument initiating EO 12866 review

105 reflects circumstances or condition that does no t reflect water quality in the distribution system.

• Approval of individuals allowe d to conduct subpart Y Level 2 assessments – States must describe their criteria and pr ocess for approval of individuals allowed to conduct subpart Y Level 2 assessments.

• Special monitoring evaluation – States must describe how they will perform special monitoring evaluations during sanitary surv eys for ground water systems serving 1,000 or fewer people to determine whether systems are on an appropriate monitoring schedule.

• Seasonal systems – States must describe how they will identify seasonal systems, how they will determine when systems on less than monthl y monitoring must monitor, and what will be the seasonal system start-up provisions.

• Additional criteria for reduced monitoring – States must describe how they will require systems on reduced monitoring to demonstrate:

− Continuous disinfection entering the distribution system and a residual in the distribution system;

− Cross connection control;

− Other enhancements to water system barriers; and

− Procedures for seasonal systems to start up operations at the begi nning of each season.
B. State Recordkeeping Requirements The current regulations in 40 CFR 142.14 require States with primacy to keep records, including: analytical results to determine compliance with MCLs, MRDLs, and treatment technique requirements; PWS inve ntories; State approvals; enforcement actions; and the issuance of variances and exemptions. The proposed RTCR requires States to keep additional records,Document initiating EO 12866 review

106 including all supporting informati on and an explanation of the t echnical basis for each decision as follows. Records of the following decisions or activities must be retained for five years, consistent with recordkeeping requ irements for existing regulations:

• Any decision to waive the 24-hour time limit for collecting repeat samples after a total coliform-positive routine sample, or to extend the 24-hour limit for collection of samples following invalidation, or for an unfiltered subpart H system to co llect a total coliform sample following a turbidity measurement exceeding 1 NTU.

• Any decision to allow a system to waive the requirement for three routine samples the month following a total coliform-positive sample. The record of the waiver decision must contain all the items listed in §§141.854(j) and 141.855(f) of the proposed RTCR.

• Any decision to invalidate a total coliform-positi ve sample. If the State decides to invalidate a total coliform-positive sample as provide d in §141.853(c)(1) of the proposed RTCR, the record of the decision must contain al l the items listed in that paragraph.

• Completed and approved 40 CFR part 141 subpart Y assessments, including reports from the system that corrective ac tion has been completed. States must retain records of each of the follo wing decisions in such a manner so that each system’s current status may be determined at any time:

• Any decision to reduce the total coliform monitoring frequency for a community water system serving 1,000 or fewer people to le ss than once per month, as provided in §141.855(d) of the proposed RTCR; and what the reduced monitoring frequency is. A copy of the reduced monitoring frequency must be provided to the system.

• Any decision to reduce the total coliform monitoring frequency for a non-community water system using only ground water and serving 1,00 0 or fewer people to less than once perDocument initiating EO 12866 review

107 quarter, as provided in §141.854(e) of the proposed RTCR, and what the reduced monitoring frequency is. A copy of the re duced monitoring frequency must be provided to the system.

• Any decision to reduce the total coliform monitoring frequency for a non-community water system using only ground water and serving mo re than 1,000 persons during any month the system serves 1,000 or fewer people, as pr ovided in §141.857(d) of the proposed RTCR. A copy of the reduced monitoring frequenc y must be provided to the system.

• Any decision to waive the 24-hour limit for ta king a total coliform sample for a public water system that uses surface water, or ground wate r under the direct influence of surface water, and that does not practice filtration in accordance with part 141, subparts H, P, T, and W, and that measures a source water turbidity leve l exceeding 1 NTU near the first service connection.

• Any decision to allow a public water system to forgo E. coli testing on a total coliformpositive sample if that system assumes that the total coliform-positive sample is E. colipositive.
C. State Reporting Requirements EPA currently requires at 40 CFR 142.15 that St ates report to EPA information such as violations, variance and exemption status, and enforcement actions. The proposed RTCR requires States to develop and maintain a list of public water systems that the State is allowing to monitor less frequently than once per month for community water systems or less frequently than once per quarter for non-community water systems, including the compliance date (the date that reduced monitoring was approved) of the reduced monitoring requirement for each system.
D. Interim PrimacyDocument initiating EO 12866 review

108 On April 28, 1998, EPA amended its State primacy regulations at 40 CFR 142.12 to incorporate the new process identified in th e 1996 SDWA Amendments for granting primary enforcement authority to States while their appl ications to modify their primacy programs are under review (USEPA 1998c, 63 FR 23361, April 28, 1998). The new process grants interim primary enforcement authority for a new or revi sed regulation during the period in which EPA is making a determination with regard to primacy fo r that new or revised regulation. This interim enforcement authority begins on the date of the primacy application subm ission or the effective date of the new or revised Stat e regulation, whichever is later, and ends when EPA makes a final determination. However, this interim primacy au thority is only availabl e to a State that has primacy (including interim primacy) for ever y existing NPDWR in effect when the new regulation is promulgated. As a result, States that have primacy (inc luding interim primacy) for every existing NPDWR already in effect may obtain interim primacy fo r the RTCR, beginning on the date that the State submits the application for this rule to EPA, or the effective date of its revised regulations, whichever is later. A State that wishes to obtain interim primacy for future NPDWRs must obtain primacy for this rule.
E. Request for Comment EPA requests comment on the adequacy of the proposed RTCR requirements for State implementation, including but not limited to St ate special primacy requirements and State reporting and recordkeeping requirements. Specifically, EPA requests comment on whether there are any requirements that shou ld be added to assure proper St ate oversight, or any that can be removed without detriment to implementation of the rule.
V. Distribution System Research a nd Information Collection ActivitiesDocument initiating EO 12866 review

109 A. Research and Information Collection Partnership The advisory committee recommended that a Research and Information Collection Partnership (RICP) be formed to inform and support the drinking water community in developing future national risk management deci sions pertaining to dri nking water distribution systems. The advisory committee recommende d seven priority areas for research and information collection. These seven priority area s are: (1) cross-conn ection and backflow of contaminated water; (2) contamination due to st orage facility design, oper ation, or maintenance; (3) contamination due to main installation, repa ir, or rehabilitation pr actices; (4) contaminant intrusion due to pressure conditi ons and physical gaps in distribu tion system infrastructure; (5) significance and control of biofilm and microbial growth; (6) n itrification issues that lead to public health effects; and (7) accumulation and re lease of contaminants from distribution system scales and sediments (USE PA 2008c, AIP p. 30). In January 2009, EPA and the Water Research Foundation (WRF or the Foundation) signed a memorandum of understanding (MOU) to form the RICP in response to recommendations from the advisory committee contained in the AIP (USEPA and WRF 200 9). The MOU conveys the partners’ agreement to collaborate and identify, define, prioritize, coordinate, and communicate critical decision-rele vant distribution system resear ch and information collection needs of the drinking water community. The RICP is directed by a steering committee comprised of nine members: thre e members from EPA, three memb ers from water utilities, and three additional members representing the publ ic health, environmental advocate, and State regulator perspectives. The partners are developing a distribution sy stem research and information collection agenda that focuses on characterizing and reducing public health risks. The identified priorityDocument initiating EO 12866 review

110 information and research will allow better unde rstanding and management of potential public health risks from drinking wa ter distribution systems. See [INSERT WEB LINK WHEN IT BECOMES AVAILABLE] for further information on this effort.
B. Distribution System Optimization Activities As part of the AIP, the advisory committee encouraged “the development of national and regional distribution system optimization partnerships that fo cus on protecting the integrity of drinking water quality once it is delivered to the distributi on system. The purpose of the partnerships should be to inform and inspire pr oactive systems to implement best management practices that emphasize protection of public health. These partnerships, comprised, for example, of representatives from utilities, co mmunities, academia, and regulatory organizations could develop continuous improvement programs that encompass water distribution optimization principles and practices for sy stem design, operations, and mainte nance. These partnerships should foster continuous review of distribution system issues and should define excellence in distribution system operation in te rms of processes, systems, procedures, as well as measures. The optimization partnerships should encourage vo luntary program particip ation of all drinking water utilities regardless of sy stem size” (USEPA 2008c, AIP p.25). EPA is aware of two distribution system optim ization programs that are currently being developed. EPA and the Foundation are conc urrently developing distribution system optimization programs that focus on protecting p ublic health in the distribution system. Developmental activities to s upport these efforts are occurring through the EPA’s National Area Wide Optimization Program (AWOP) and th e Foundation’s project #4109. While these programs are being developed independently with differing measures of performance, both are founded on the optimization principles of improving water systems, and go beyond theDocument initiating EO 12866 review

111 regulatory requirements, while using existing staff and facilities. These principles and practices are currently being used thr ough the in-plant treatment optim ization programs operated through AWOP and the American Water Works Association’s (AWWA) Partnership for Safe Water (the Partnership). For more information on the Partnership for Safe Water, see ( http://www.awwa.org/Resources/Partnership forSafeWater.cfm?ItemNumber=3787&navItemNu mber=33969)

. The goal of EPA’s optim ization program is to protect public health by addressing both the technical and management issues that limit the water system’s ability to meet water quality performance goals. EPA has started developi ng a distribution system optimization program, which is currently focused on improving water treatment plant finished water quality while maintaining disinfectant residual and minimi zing disinfection byproduct formation in the distribution system. Future work may focus on other water quality parameters or issues of concern. An outcome of this effort will be the identification of the key technical and management skills, practices, and tools that a water system should implement to achieve longterm distribution system optimization. Ultimatel y, participating AWOP States will be introduced to distribution system optimization methods developed by EPA. At this time, additional development activities are needed before a di stribution system optimization program will be available for State implementation. In 2007, the Foundation initiated project #4109 to identify a limited number of straightforward criteria that can be used by wa ter utilities to measur e distribution system optimization performance and to develop a se lf-assessment approach using standards of excellence. The results from this project will al so be used to expand the Partnership for Safe Water Program treatment plant optimization progra m into distribution system optimization. TheDocument initiating EO 12866 review

112 Foundation anticipates proj ect #4109 to be completed by early 2010. With the results of project #4109, the Partnership anticipates fi nalizing a preliminary set of optimization goals and a model assessment process in calendar year 2010. Prior to finalizing the goals and assessment process, the Partnership will conduct trials at several vol unteer utilities. The optimization goals and assessment process will be evaluated and refined based on those trials prior to consideration by the Partnership for adoption and implementation. AWWA anticipates that applications for the Partnership’s Distribution System Optimization Program will be available in calendar year 2011.
C. Request for Comment EPA requests comment about these distribu tion system optimization projects and information about or suggestions for other possible approaches to distribution system optimization.
VI. Economic Analysis (Health Ri sk Reduction and Cost Analysis) This section summarizes the Health Risk Reduc tion and Cost Analysis (HRRCA) in support of the proposed RTCR as required by section 14 12(b)(3)(C) of the SDWA . EPA has prepared the RTCR Economic Analysis (EA) (USEPA 2009a) to comply with this requirement. The EA document for the proposed RTCR is available in the docket and is al so published on the government’s Web site at http://www.regulations.gov

. The HRRCA consists of seven elements: (1) quantifiable and nonquantifiable health risk reduction benefits; (2) quantifia ble and nonquantifiable health ri sk reduction benefits from reductions in co-occurring contaminants; (3) qua ntifiable and nonquantifiable costs that are likely to occur solely as a result of compliance; (4) incremental costs and benefits of rule options; (5) effects of the contaminant on the general population and sens itive subpopulations including infants, children, pregnant women, elderly, and indi viduals with a history of serious illness; (6) any increased health risks that may occur as a result of compliance, including risks associatedDocument initiating EO 12866 review

113 with co-occurring contaminants; and (7) other rele vant factors such as uncertainties in the analysis and factors with respect to the de gree and nature of risk. See SDWA section 1412(b)(3)(C). A summary of these elements is pr ovided in this section of the preamble, and a complete discussion can be found in th e Proposed RTCR EA (USEPA 2009a). Both the benefits and the costs discussed in th is section are presente d as annualized present values in 2007 dollars using social discounting. In social discounting, future values of a rule’s or policy’s effects are multiplied by discount factors. The discount factors reflect both the amount of time between the present and the point at whic h these events occur and the degree to which current consumption is more highly valued th an future consumption (USEPA 2000c). This process allows comparison of cost and benefit streams that are variable over a given time period. EPA uses social discount rates of both three percen t and seven percent to calculate present values from the stream of benefits and costs and al so to annualize the pres ent value estimates. Historically, the use of three percent is ba sed on rates of return on relatively risk-free investments, as described in the Guidelines for Preparing Economic Analyses (USEPA 2000c). The rate of seven percent is a recommendation of the Office of Management and Budget (OMB) as an estimate of “before-tax rate of return to incremental private investment” (OMB 1996). In the Proposed RTCR EA (USEPA 2009a), EPA al so presents the undiscounted stream of benefits and costs over the 25-year time frame (i.e., the year-to-y ear realization of benefits and costs presented in constant terms). The time frame used for both benefit and cost comp arisons in this rule is 25 years. This time interval accounts for rule implementation ac tivities occurring soon after promulgation (e.g., States adopting the criteria of the regulation) and the time fo r different types of compliance actions (e.g., assessments and corrective actions) to be rea lized up through the 25 th year following rule promulgation. EPA was unable to quantify health benef its for the proposed RTCR because there are insufficient data reporting the co-occurrenc e in a single sample of fecal indicator E. coli and pathogenic organisms. In additi on, the available fecal indicator E. coli data from the Six-YearDocument initiating EO 12866 review

114 Review 2 dataset described in this preamble we re limited to presence-absence data because the current TCR requires only the reporting of presence or absence of fecal indicator E. coli using EPA-approved standard methods. However, as di scussed in chapter 6 of the Proposed RTCR EA (USEPA 2009a), even though health benefits co uld not be directly quantified, the potential benefits from the proposed RTCR include avoidan ce of a full range of health effects from the consumption of fecally contaminated drinking wa ter, including the follo wing: acute and chronic illness, endemic and epidemic disease, waterborne disease outbreaks, and death. Also, since fecal contamination may contain wa terborne pathogens including b acteria, viruses, and parasitic protozoa, in general, a reduction in fecal contamination should reduce the risk from these other contaminants. The net costs of the rule stem mostly from the new assessment corrective action requirements as well as the revised monitoring provisions described earlie r in this preamble. This section of the preamble includes elem ents as follows: (A) Regulatory Options Considered, (B) Major Sources of Data and Information used in Supporting Analyses, (C) Occurrence and Predictive Modeli ng, (D) Baseline Profiles, (E) Anticipated Benefits of the Proposed RTCR, (F) Anticipated Costs of the Proposed RTCR, (G) Potential Impact of the Proposed RTCR on Households, (H) Incremental Costs and Benefits, (I) Benefits from Simultaneous Reduction of Co-occurring Contamin ants, (J) Change in Risk from Other Contaminants, (K) Effects of Fecal Contamination and/or Waterborne Pathogens on the General Population and Sensitive Subpopulati ons, (L) Uncertainties in the Benefit and Cost Estimates for the Proposed RTCR, (M) Benefit Cost Determination for the Proposed RTCR, and (N) Request for Comment.
A. Regulatory Options Considered EPA evaluated the following three regulatory options as part of this revised rule proposal: (1) the current TCR option, (2) the AIP option, and (3) an Alternative opti on. EPA discusses theDocument initiating EO 12866 review

115 three regulatory options briefly in this preamble and in greater detail in chapter 3 of the Proposed RTCR EA (USEPA 2009a). First, the current TCR option reflects EPA’s understanding of how the current TCR (USEPA 1989a, 54 FR 27544, June 29, 1989) is currently bei ng implemented. That is, the current TCR option is assumed to include “status quo” PWS and State implementation practices. Next, the AIP option is a revised TCR based on the recommendations of the advisory committee. The provisions of this proposed rule are based on the AIP option and are described in detail in section III of this preamble. Third, the Alternative optio n parallels the AIP in most ways but includes variations of some of the provisions that were discussed by the advisory committee before consensus was reached on the AIP. The Alternative option differs from the AIP optio n in two ways. First, under the Alternative option, at the compliance date all PWSs are required to sample monthly for an initial period until they meet the eligibility criteria for reduced monitoring. EPA assumes that eligibility for reduced monitoring is determined during th e next sanitary survey following the RTCR compliance date (corresponding to the 11 th year of the model runs presented later on in this preamble). This more stringent approach diffe rs from the AIP option that allows PWSs to continue to monitor at their current frequencies (with an additional annual site visit or voluntary Level 2 assessment requirement for PWSs wishi ng to remain on annual monitoring) until they are triggered into an increased sampling fr equency. Second, under the Alternative option, no PWSs are allowed to reduce monitoring to an annual basis. EPA defined the Alternative option this way and included it in the Proposed RT CR EA (USEPA 2009a) to assess the relative impacts of a more stringent rule and to better understand the balance between costs and public health protection.Document initiating EO 12866 review

116 To understand the relative impacts of the op tions, EPA gathered available data and information to develop and provide input into an occurrence and pr edictive model. EPA estimated both baseline conditions and changes to these conditions anticipated to occur over time as a result of these revised rule options. The anal ysis is described in more detail in the Proposed RTCR EA (USEPA 2009a).
B. Major Sources of Data and Information used in Supporting Analyses This section of the preamble briefly discusse s the data sources that EPA used in its supporting analyses for the proposed RTCR. For a more detailed discussion, see chapter 4 of the Proposed RTCR EA (USEPA 2009a).
1. Safe Drinking Water Information System Federal Version data Safe Drinking Water Information System Fede ral Version (SDWIS/FED) is EPA’s national regulatory compliance database for the drinking water program and is th e main source of PWS inventory and violation data for the proposed RTCR baseline. SDWIS/FED contains information on each of the approximately 155,000 active PWSs as reported by primacy agencies, EPA Regions, and EPA headquarters personne l. SDWIS/FED includes records of MCL violations and monitoring and re porting (MR) violations (both r outine and repeat and minor and major). It does not include sample results. It also contains information to characterize the US inventory of PWSs including system name a nd location, retail population served, source water type (ground water (GW), surface water (SW), or ground water under the direct influence of surface water (GWUDI)), disinfect ion status, and PWS type (community water system (CWS), transient non-community water system (TNC WS), and non-transient non-community water system (NTNCWS)).Document initiating EO 12866 review

117 To create the PWS and population baseline, EP A used the fourth quarter of SDWIS/FED 2007 (USEPA 2007b), which was the most current PWS inventory data available when EPA began developing the Proposed RTCR EA. These data represent all current, active PWSs and the population served by these systems. EPA also used the MCL violation data from SDWIS/FED to validate model predictions for systems serving 4,100 or fewer people and to predict E. coli (acute) MCL violations (current TCR, AIP, and Alternative option), total colif orm (non-acute or monthly) MCL violations (current TCR), and Level 1 and Level 2 assessmen t triggers (AIP and Alternative option) for systems serving more than 4,100 people.
2. Six-Year Review 2 data Through an Information Collection Request (USEPA 2006b), States voluntarily submitted electronically available TCR mon itoring data (sample results) that were collected between January 1998 and December 2005. EPA requested th e TCR monitoring results with the intent of conducting analyses and developing models to assess the potentia l impacts of changes to the current TCR. EPA received data from 46 States, Tribes, and territories. A Data Quality Report (USEPA 2009c) describes how TC R monitoring data were obtain ed, evaluated, and modified where necessary to make the database internally consistent and usable for analysis. Exhibit 2.1 in the Data Quality Report provides a complete list of States or territories that submitted data and a description of the use of these data. In this EA, EPA included data from 37 primacy agencies (35 States and 2 Tribes). Records included data for:

• PWS information (system type, popul ation served, source water type)

• Sample type (routine, repeat, special purpose)Document initiating EO 12866 review

118 • Analytical result

• Sampling location – entry point, distribution sy stem and, for repeat samples, original location, downstream, upstream, and other

• Analytical method

• Disinfectant residual data collected at TCR monitoring sites As discussed in greater detail in section 4.2.2.1 of the Proposed RTCR EA (USEPA 2009a), EPA used 2005 data exclusively in the an alyses supporting the proposed RTCR because the 2005 data set was the most complete year of data among the Six-Year Review 2 data. The 2005 data was also the most recent data ava ilable suggesting that it may be the most representative of pres ent conditions. The Six-Year Review 2 data also informed EPA’s assumptions regarding the proportions of GWSs serving 1,000 or fewer people that sample monthly, quarterly, or annually.
3. Other information sources Additional data and information sources in cluded the Economic Analysis for the Ground Water Rule (GWR EA) (USEPA 2006a), the Technology and Cost Document for the Proposed Revised Total Coliform Rule (proposed RTCR T&C document) (USEPA 2009b), the US Census data, and the knowledge and experience of stake holders representing industry, States, small systems, and the public. The GWR EA provided occurrence information on E. coli in the source water of ground water PWSs for modeling the triggered mon itoring component of GWR and informed the assumptions on the distribution of corrective actions taken in response to the presence of E. coli in the source water. As discussed in section VI.C.1 of this preamble, the model developed for this economic analysis considers the effect of GWR both before and during implementation ofDocument initiating EO 12866 review

119 the proposed revised rule. The proposed RTCR T&C document included estimates of unit costs for the major components of the proposed RTCR including labor, monitoring, assessments, and corrective actions. US Census data were us ed to estimate populati on per household and to characterize sensitive subpopulations. Lastly, k nowledge and experience from stakeholders helped to inform the assumptions that were made for the analysis. A more detailed discussion of these data sour ces and how EPA used them are included in the Proposed RTCR EA (USEPA 2009a).
C. Occurrence and Predictive Modeling EPA used the data to develop an occurrenc e and predictive model for PWSs serving 4,100 or fewer people based primarily on the 2005 Six-Year Review 2 data. The model predicts changes in total coliform and E. coli occurrence, Level 1 and Level 2 assessments (based on simulated monitoring results), corrective actions , and violations over time. EPA developed another, simpler, predictive model, for PWSs serving more than 4,100 people, that predicts Level 1 and Level 2 assessments (based on 2005 violati on data from SDWIS/FED), corrective actions, and violations over time, but not total coliform and E. coli occurrence. EPA modeled systems serving more than 4,100 people separately because the Six Year Review 2 data for larger PWSs were not as robust as the data for the smaller systems. In addition, while EPA is proposing new monitoring requirements for PWSs serving 4,100 people or fewer, proposed monitoring requirements for systems serving greater than 4,1 00 people remain essentially unchanged. This section briefly discusses the structures of each of the two models and how they used available data, information, and assumptions to make pr edictions over time result ing from the proposed regulatory options.Document initiating EO 12866 review

120 Chapter 5 of the Proposed RTCR EA (USEPA 2009a) includes a more detailed description of the occurrence and predictive model used for PWSs serving 4,100 or fewer people, and the other simpler predictive model used for PWSs serving greater than 4,100 people.
1. Model used for public water systems serving 4,100 or fewer people The occurrence and predictive model used fo r PWSs serving 4,100 or fewer people has two components. The first component of the model characterized how the pr esence or positive rates of total coliform and E. coli detections vary across the popul ation of small (serving 4,100 or fewer people) public water systems in the US. Thes e rates vary by the type of sample (routine or repeat), by analyte (t otal coliforms or E. coli ), and by system type (CWS, NCWS, or TNCWS) and size. The second component of th e model used the total coliform and E. coli occurrence distributions to simulate a set of nationally-representative systems within the context of the three regulatory options (TCR, AIP, and Alternative) to predict changes in total coliform and E. coli occurrence, triggers, assessments, correctiv e actions over time, and violations. The model assumed that the national occurrence of total coliforms and E. coli has reached a steady state in recent years under the current TCR. It a ssumed that cycles of normal deterioration and repair/replacement are occurring at the individual system level, on average. However, the numbers of violations at the natio nal level have remained relatively unchanged. This assumption is based on evaluati on of SDWIS/FED violation data. Exhibit VI-1 presents the

num ber of PWSs with TCR violations over the last several years whic h shows that national violation rates have remained relatively steady over the past several years. Revisions to the TCR affect this steady state, likely resulting in a re duction of the underlying occurrence and associated violations. However, before the RTCR goes into effect, GWR implementation begins which is also expected to affect the steady state.Document initiating EO 12866 review

121 Exhibit VI-1 Number of PWSs with Violations by System Type (2001 – 2007)

Note: PWSs counts are of systems that ha d at least one violation during the year. Source: SDWIS/FED annual data for period ending 3 rd quarter 2001 – 2007. OH, US territories, Tribal PWS data excluded. To estimate the effects that GWR implementation is expected to have on present steady state conditions, EPA used the occurrence and pred ictive model to simulate five years of implementation of the current TCR with GWR. EPA assumed five years to account for the approximately two years before the expected prom ulgation date of RTCR and an additional three years after that until th e RTCR effective date. The assumptions made to account for the GWR are described in detail in th e in the Proposed RTCR EA (USEPA 2009a) and summarized in Exhibit VI-2.

Exhibit VI-2 Summary o f Major Assumptions for Simulating GWR Implementation

GWR Provision Modeling Approach / Assumption Triggered Monitoring : GWSs not providing 4-log treatment for viruses that have total coliform-positive samples under current TCR are required to take s ource water samples and test for fecal indicator. If the sample is positive, they must take an additional 5 source Current model used same probabilities used in GWR EA (USEPA 2006a) to predict whether source water samples will be E. coli -positive. GWSs required to conduct corrective action due to monitoring results will either installDocument initiating EO 12866 review

122 water samples (unless the State requires corrective action). If any of these is positive, they must conduct corrective action. disinfection or implement a nondisinfecting corrective action as de scribed in Proposed RTCR EA (USEPA 2009a). GWSs installing disinfection will draw from the probability distributions for total coliforms and E. coli for disinfected systems for the remainder of analysis. GWSs implementing a nondisinfecting corrective action will experience no positive samples for the remainder of the year plus two additional years and will experience a 75 1 percent reduction in occurrence for five additional years. Sanitary Surveys: GWR includes Federal sanitary survey requirements for all GWSs, and requires States to perform regular comprehensive sanitary surveys including eight critical elements. Model did not explicitly simulate sanitary surveys or their results. Rather, it assumed that the new sanitary survey provisions will result in 10 percent 2 reduced occurrence of total coliforms universally for entire analysis. Compliance Monitoring: GWSs that provide 4-log treatment for viruses must demonstrate that they are providing th is level of treatment by conducting compliance monitoring. Model did not explicitly simulate compliance monitoring. Rather, it assumed that the provision will result in 10 percent 3 reduced occurrence of total colif orms for those GWSs that are conducting compliance monitoring once assumed 4-log treatment for viruses begins. 1,2,3 Assumption reflects EPA be st professional judgment. Source: Proposed RTCR EA (USEPA 2009a) as informed by GWR EA (USEPA 2006a). Actual reductions in occurrenc e that are expected to result from the implementation of GWR requirements may differ from what is presented here. However, based on assumptions used in this model, the analysis of how the AIP and Alte rnative option perform rela tive to each other are not affected. In addition to capturing the effect of implem entation of GWR requireme nts with the current TCR for a five-year period of analysis, the model captures an additional 25 years with the current TCR, the AIP option, and the Alternative option. Along with changes in total coliform and E. coli occurrence, the model predicts behavioral ch anges: the number of Level 1 and Level 2Document initiating EO 12866 review

123 assessments (and associated Level 1 or Level 2 corrective actions) to be performed, further resulting adjustments to occurrence, and change s in sampling regimens as systems qualify for reduced monitoring requirements. The assumpti ons used to simulate RTCR implementation are detailed in the Proposed RTCR EA (USEPA 2009a) and summarized in Exhibit VI-3.
Exhibit VI-3 Summary o f Major Assumptions for Simulating Proposed RTCR Implementation
Proposed RTCR Provision Modeling Approach / Assumption

Level 1 Assessment Model simulates sampling and sampling results and determines which PWSs will be triggered to conduct an assessment. Sanitary defects are found in 10 percent 1 of assessments (represents net increase over current TCR). All sanitary defects are corrected. Model selects from distribution of potential corrective actions as expl ained in chapter 7 of the Proposed RTCR EA (USEPA 2009a). PWSs implementing a corrective act ion as a result of a Level 1 assessment experience no positive samples for the remainder of the year plus one additional year and will experience 50 percent 2 reduction in occurrence for three additional years.

Level 2 Assessment Model simulates sampling and sampling results and determines which PWSs will be triggered to conduct an assessment. Sanitary defects will be found in 10 percent 3 of assessments (represents net increase over current TCR). All sanitary defects are corrected. Model selects from distribution of potential corrective actions as expl ained in chapter 7 of the Proposed RTCR EA (USEPA 2009a). PWSs implementing a corrective act ion as a result of a Level 2 assessment will experience no positive samples for the remainder of the year plus two additional years and will experience 75 percent 4 reduction in occurrence for five additional years.Document initiating EO 12866 review

124 1,3 Assumption based on conversation with State re presentatives with on-the-ground experience. 2,4 Assumption reflects EPA best professional judgment. Note: EPA recognizes that there is a large uncertain ty with the assumptions. Sensitivity analyses showed that the fundamental conclusions of th e economic analysis do not change over a wide range of assumptions tested. Source: Proposed RTCR EA (USEPA 2009a)
EPA made different assumptions for the eff ectiveness of assessments and subsequent corrective actions to account for the differences between the tw o types of assessments. The Level 2 assessment is a more comprehensive in vestigation that may re sult in finding more substantial problems than what may be found dur ing a Level 1 assessment, and for that reason the corrective actions that result from a Level 2 assessment were modeled to have bigger and longer lasting effects than those of the Level 1 assessments. EPA conducted sensitivity analyses around the key assumptions summarized in Exhibit VI-2 as discussed in section VI.L of this
pream ble.
2. Model used for public water systems serving more than 4,100 people For systems serving more than 4,100 people, EP A estimated violation and trigger rates using SDWIS/FED because the Six-Year Review 2 data for PWSs serving more than 4,100 people were not as robust as the Six-Y ear Review 2 data for systems serving 4,100 or fewer people. EPA did not quantify changes in violation or tr igger rates for systems serving more than 4,100 people among the current TCR, AIP, and Alterna tive options because of: (1) limited Six-Year Review 2 data to characterize these syst ems, (2) the essentially unchanged monitoring requirements across options for these systems, and (3) the level of effort already occurring to implement the TCR.
D. Baseline ProfilesDocument initiating EO 12866 review

125 The estimate of baseline conditions that EPA developed provides a reference point for understanding net impacts of th e proposed rule revisions. Compliance with the GWR begins in Decembe r 2009, and the expected compliance date of the RTCR is approximately five years followi ng commencement of the GWR implementation. The majority of PWSs are GWSs and these systems are expected to be affected by the GWR. Because GWR implementation prior to the effectiv e date of RTCR is expected to cause changes to GWSs, the baseline conditions that EPA deve loped for GWSs account for the expected effects of the GWR. For PWSs serving more than 4,100 people, EPA assumed that present conditions, as reflected in 2005 SDWIS/FED data, are an appropria te representation of th e conditions that are likely to exist when the RTCR becomes effective. EPA assumed that a steady state exists at the national level. The number of GW PWSs that di sinfect is expected to change during implementation of the GWR before the expected rule comp liance date of the proposed RTCR. Exhibit VI-4 shows the estim ated baseline number of the GW PWSs at the proposed RTCR compliance date.

Exhibit VI-4 Estimated Baseline Number of GW Sy stems and Disinfection Status at compliance date (3 years post RTCR promulgation)Document initiating EO 12866 review

126 Disinfecting Non-Disinfecting Disinfecting Non -Disinfecting Disinfecting Non-Disinfecting
≤ 100 6,308 5,630 2,937 5,889 13,781 46,419 101 - 500 9,326 4,566 2,777 3,836 5,459 13,816 501-1,000 3,516 951 873 845 685 1,278 1,001-4,100 5,423 1,020 547 265 274 343 4,101-33,000 2,798 358 56 14 27 40 33,001-96,000 307 28 2

- - 2 96,001-500,000 62 1

- - - 1 500,001-1 Million 4

- - - - 1 > 1 Million 3

- - - - - Total 27,746 12,555 7,192 10,849 20,226 61,900 Combined Total PWS Size Number of GW PWSs (Post-GWR)

40,301 18,041 82,126

CWS NTNCWS TNCWS

Source: Proposed RTCR Occurrenc e and Predictive Model Output as detailed in the Proposed RTCR EA (USEPA 2009a)

EPA estimated the numbers of GW PWSs th at monitor monthly, quarterly, and annually under the current TCR based on an analysis of th e Six-Year Review 2 da ta and individual State statutes conducted by EPA and the advisory committee Technical Workgroup (TWG). Of the GW PWSs serving 1,000 or fewer people, EP A estimated that approximately 34,000 monitor monthly, 67,000 monitor quarterly, and 27,000 mon itor annually. EPA assumed that the numbers of systems on monthly, quarterly, and annual monitoring remain unchanged at the rule effective date for either a continuation of th e current TCR or for the AIP option. Under the Alternative option, all PWSs, regard less of size or type, start at monthly monitoring at the rule effective date. The following two tables provide an overview of summary statistics relating to baseline water quality. Exhibit VI-5 shows the percen tage of total coliform - and E. coli -positive samples based on PWS type and size. The percentages of samples that are total coliform-positive are generally higher in ground water systems than in surface water systems; in smaller systems than in larger systems; and in NCWSs than in CWSs.
Exhibit VI-5 Total Coliform and E. coli Percent Positive by System Size and TypeDocument initiating EO 12866 review

127 PWS Type Source Water Population Served TC (# Samples) TC (+ Samples) TC (% Positive) EC (# Samples) 1 EC (+ Samples) EC (% Positive) 2
≤ 100 93,105 2,479 2.66% 1,172 72 0.08% 101 - 500 125,490 2,500 1.99% 1,639 61 0.05% 501-1,000 48,265 736 1.52% 483 20 0.04% 1,001-4,100 110,391 1,176 1.07% 732 21 0.02% 4,101-33,000 183,721 877 0.48% 458 22 0.01% 33,001-100,000 96,361 214 0.22% 44 2 0.00% >100,000 64,965 289 0.44% 34 1 0.00% Total GW 722,298 8,271 1.15% 4,562 199 0.03% ≤ 100 6,735 95 1.41% 64 6 0.09% 101 - 500 19,716 227 1.15% 159 10 0.05% 501-1,000 12,828 90 0.70% 70 7 0.05% 1,001-4,100 55,310 314 0.57% 233 17 0.03% 4,101-33,000 175,758 525 0.30% 399 41 0.02% 33,001-100,000 112,894 157 0.14% 106 5 0.00% >100,000 112,143 235 0.21% 99 2 0.00% Total SW 495,384 1,643 0.33% 1,130 88 0.02% GW & SW Total CWS 1,217,682 9,914 0.81% 5,692 287 0.02% ≤ 100 163,730 7,820 4.78% 5,820 316 0.20% 101 - 500 52,891 2,418 4.57% 1,869 99 0.19% 501-1,000 6,952 299 4.30% 217 4 0.06% >1,000 7,062 143 2.02% 85 2 0.03% Total GW 230,635 10,680 4.63% 7,991 421 0.18% ≤ 100 6,723 150 2.23% 141 17 0.25% 101 - 500 2,854 75 2.63% 69 13 0.46% 501-1,000 523 19 3.63% 19

- 0.00% >1,000 988 6 0.61% 37

- 0.00% Total SW 11,088 250 2.25% 266 30 0.27% GW & SW Total TNCWS 241,723 10,930 4.52% 8,257 451 0.19% ≤ 100 46,505 1,476 3.17% 1,061 34 0.07% 101 - 500 33,084 893 2.70% 628 19 0.06% 501-1,000 9,531 166 1.74% 103 2 0.02% >1,000 13,138 177 1.35% 103 5 0.04% Total GW 102,258 2,712 2.65% 1,895 60 0.06% ≤ 100 1,668 32 1.92% 30 4 0.24% 101 - 500 2,304 9 0.39% 9 2 0.09% 501-1,000 932 6 0.64% 5

- 0.00% >1,000 1,316 1 0.08% 1

- 0.00% Total SW 6,220 48 0.77% 45 6 0.10% GW & SW Total NTNCWS 108,478 2,760 2.54% 1,940 66 0.06% NTNCWS GW

SW CWS GW

SW

TNCWS GW

SW

1 Number of E. coli samples is the denominator of the E. coli percent positive calculation, and includes the number of total coliform negative samples plus the number of total coliform-positive samples that were tested for E. coli

. 2 Percent E. coli -positive was calculated as (number of E. coli -positive samples)/(number of E. coli samples taken). Source: Derived using Six-Year Review 2 Data , which was filtered by including a State only if the State’s PWSs as a group had submitted at leas t 50 percent of the expected sample-months of usable data. The Total Coliform Rule Complia nce Monitoring Data Quality and Completion Report (USEPA 2009c) includes a detailed description of this data cleaning process.Document initiating EO 12866 review

128 Exhibit VI-6 presents the number of acute a nd non-acute violations received by PWSs. The number of violations is also an indicator of baseline water quality prior to implementation of the proposed RTCR. As discussed in detail chapter 5 of the Proposed RTCR EA (USEPA 2009a), EPA used these data to estimate the numbers of MCL violations and triggers for PWSs serving more than 4,100 people for the three options. Under the current TCR, la rger systems incur a relatively small number of violations annuall y, while smaller systems incur the majority.

Exhibit VI-6 Baseline Number of TCR Violations by System Size and Type (2005)Document initiating EO 12866 review

129 Non-Acute Acute Total Non-Acute Acute Total

≤ 100 905 52 957 16 3 19 976 101-500 809 34 843 50 7 57 900 501-1,000 203 13 216 16 3 19 235 1,001-3,300 272 8 280 55 7 62 342 3,301-10,000 171 8 179 75 3 78 257 10,001-50,000 125 8 133 78 4 82 215 50,001-100,000 11 2 13 5 4 9 22 100,001-1 Million 1 1 2 3 1 4 6 >1 Million

- - - 1 - 1 1 Totals 2,497 126 2,623 299 32 331 2,954

≤ 100 514 34 548 7 2 9 557 101-500 346 20 366 4 - 4 370 501-1,000 57 6 63 2 - 2 65 1,001-3,300 58 4 62 - - - 62 3,301-10,000 9 2 11 1 - 1 12 10,001-50,000 1 - 1 - - - 1 50,001-100,000

- - - - - - - 100,001-1 Million - - - - - - - >1 Million

- - - - - - - Totals 985 66 1,051 14 2 16 1,067

≤ 100 2,665 278 2,943 19 5 24 2,967 101-500 833 76 909 11 1 12 921 501-1,000 133 11 144 4 - 4 148 1,001-3,300 58 2 60 1 - 1 61 3,301-10,000 5 - 5 1 - 1 6 10,001-50,000

- - - - - - - 50,001-100,000

- - - - - - - 100,001-1 Million - - - - - - - >1 Million

- - - - - - - Totals 3,694 367 4,061 36 6 42 4,103 Grand Total 7,176 559 7,735 349 40 389 8,124 TNCWSs All PWSs Total GW PWSs SW PWSs

CWSs

NTNCWSs

Note: The proposed RTCR EA uses violations da ta for PWSs serving greater than 4,100 people to estimate triggers for these systems. Data fo r other system sizes is provided for reference. Source: SDWIS/FED 2005 3 rd quarter data. OH, US territories, Tribal PWS data excluded. See the Proposed RTCR EA (USEPA 2009a) for additional details.
E. Anticipated Benefits of the Proposed RTCR In promulgating the RTCR, EPA expects to fu rther reduce the risk of contamination of public drinking water supplies from the current base line risk under the curre nt TCR. The options considered during development of this proposed ru le and analyzed as part of the Proposed RTCRDocument initiating EO 12866 review

130 EA (USEPA 2009a) are designed to achieve this reduction while maintaining public health protection in a cost-effective manner. This section examines the benefits in terms of trade-offs among compliance with the current TCR option, the AIP option, and the Alternative option. Because there are insufficient data reporting the co-occurrence in a sing le sample of fecal indicator E. coli and pathogenic organisms and because the available fecal indicator E. coli data from the Six-Year Review 2 dataset were limited to presence-absence data, EPA was unable to quantify health benefits for the proposed RTCR. EPA used severa l methods to qualitatively evaluate the benefits of the proposed RTCR options. The qualitative evaluation uses both the judgment of EPA as informed by the TCRDSAC deliberations as well as quantit ative estimates of changes in total coliform occurrence and counts of systems implemen ting corrective actions. The evaluation characterizes, in relative terms, the reduction in risk for each regul atory scenario as compared to baseline conditions. Since E. coli is an indicator of fecal contamina tion, EPA assumed that a decrease in E. coli occurrence in the distribution system would be associated with a decrease in fecal contamination in the distribution system. In general, this decrease in fecal contamination should reduce the potential risk to human health for PW S customers. Thus, any reduction in E. coli occurrence is considered a benefit of the proposed RTCR. Also, since fecal contamination may contain waterborne pathogens incl uding bacteria, viruses, and parasitic protozoa, in general, a reduction in fecal contamination should also reduce the risk from these other contaminants. As presented in Exhibit VI-5, the percentages of sample s that are positiv e for total coliforms and E

. coli are generally higher for PWSs serving 4,100 or fewer people than those serving more than 4,100 people. PWSs with higher total coliform and E. coli occurrence are more likely to beDocument initiating EO 12866 review

131 triggered into assessments and corrective action. As discussed previous ly, the assessments and corrective action lead to a decrease in total coliform and E. coli occurrence. Because the PWSs serving 4,100 or fewer peopl e have a higher initial E. coli occurrence and are likely triggered into more assessments and corrective actions than larger PWSs, the increase in benefits for these small systems are likely more evident as compared to the larger systems. In particular, model results suggest that customers of small ground water TNCWSs serving 100 or fewer people, which constitute approximately 40 percent of PW Ss, experience the most improvement in water quality under the proposed RTCR. That is, the occurrence of E. coli is predicted to decrease more for these systems than for other systems types.
1. Relative risk analysis When revising an existing drinki ng water regulation, one of the ma in concerns is to ensure that backsliding on water quality and public health protection doe s not occur. SDWA requires that EPA at least maintain or improve public health protection for any rule revision. The proposed RTCR is more stringent th at the current TCR with regard to protecting public health. The basis for this perspective is provided in this subsection and th e following subsections (sections VI.E.1 – 3) of this preamble. Risk reduction for the proposed RTCR is charac terized by the activities performed that are presumed to reduce risk of exposing the public to contaminated water. These activities are considered under each rule component presented in Exhibit VI-8. More frequent m onitoring has the potential to decrease the risk of contamination in PWSs based on an enhanced ability to diagnose and m itigate system issues in a more timely fashion. Conversely, less frequent monitori ng has the potential to increase risk. Real-time continuous sampling would mitigate the most risk possible based on sampling schedule; however, it wouldDocument initiating EO 12866 review

132 cost prohibitively more than the periodic samp ling practiced under the cu rrent TCR and included in the AIP and the Alternativ e options. EPA’s objective in proposing the sampling schedules included in the AIP and Alternative options wa s to find an appropriate balance between the factors of risk mitigation and cost management. Under the AIP and Alternative options, the redu ction in the number of repeat samples and additional routine samples for some PWSs has the potential to contribute to increased risk for PWS customers (see also sections III.A.3 and II I.A.4 of this preamble for discussions on the repeat sample and additional routine sample provisi ons respectively). Howeve r, this increase in risk is expected to be more than offset by pot ential decreases in risk from increased routine monitoring (see section III.A.3 of this preamble) and the addition of the assessments and corrective action provisions (see s ection III.A.5 of this preamble) that find and fix problems indicated by monitoring. Exhibit VI-7 illustrate s the predicted reduced frequency at which total coliforms occur subsequent to the implementa tion of the AIP and Alte rnative options. As discussed previously, the proposed RTCR uses to tal coliform occurrence as an indicator of potential pathways for possible contamination to enter the distribution system (see section III.A.2 of this preamble). Exhibit VI-7 illustrates the combined effects on total coliform occurrence resulting from changes in monitoring and the e ffects of assessments and corrective actions for the different rule options illustrated. The relative trends indicated in Exhibit VI-7 for transient non-community water systems also pertain to other PWS categories as illustrated in chapter 5 of the Proposed RTCR EA (USEPA 2009a). EPA chose to include the characterization for TNCWSs because they represent the system cat egory of largest influence on the national impacts.
Exhibit VI-7 GW Transient Non-community Water System Total Coliform OccurrenceDocument initiating EO 12866 review

133 Source: Proposed RTCR occurrence model as described in the Proposed RTCR EA (USEPA 2009a). The effect that the proposed changes to publ ic notification requirements for monthly/nonacute MCL violations have on risk is difficult to predict. Some factors, such as reduction in available public information and possible PWS complacency, lead to a potential increase in risk and other factors, such as less confusion (PN more in line with potential health risks) and PWSs resources used more efficiently, lead to a potential decrease, as discussed in Exhibit VI-8. This change to P N is addressing a key concern expr essed by various stakeholders in the advisory committee and during the Six-Year Review 1 comment solicitation pr ocess. By eliminating the requirement and replacing it with assessment a nd corrective action requi rements, the Agency expects less public confusion, more effective us e of resources, and increased transparency. Other proposed rule components are expected to have a negligible effect on risk. However, theDocument initiating EO 12866 review

134 overall effect of the proposed RT CR is expected to be a further reduction in risk from the current baseline risk under the current TCR. Chap ter 6 of the Proposed RTCR EA (USEPA 2009a) presents a detailed discussion of the potential influence on hea lth risk for each proposed rule component.

Exhibit VI-8 Potential Changes in Risk under the AIP and Alternative Options Relative to the Current TCR
Proposed Rule

Component Factors Leading to a Potential Increase in Risk Factors Leading to a Potential Decrease in Risk Overall Predicted Change in Risk

AIP Alternative AIP Alternative AIP Alternative Implementation Activities None None None None No change No change

Routine Monitoring (Including Reduced Monitoring) None None Increased stringency in requirements to qualify for reduced monitoring along with requirement to return to baseline monitoring upon loss of these criteria is expected to result in decreased risk (That is, fewer PWSs will qualify and therefore monitor more frequently than under the baseline for reduced PWSs all monitor monthly in the first few years of implementation of the RTCR, which is an increase in sampling frequency for systems that monitor quarterly or annually under the current TCR. After the first few years, systems may reduce to quarterly, but none may reduce to annual monitoring, creating a decrease in risk for systems on Decrease DecreaseDocument initiating EO 12866 review

135 monitoring) annual monitoring under the current TCR

Repeat Monitoring Required repeat samples reduced from 4 to 3 for systems serving <1,000 people Same as AIP option

None None Increase Increase

Additional Routine Monitoring Additional routine samples are no longer required for PWSs monitoring monthly. Ground water PWSs serving 1,000 or fewer people reduce additional routine samples from 5 to 3. Same as AIP option

None None Increase Increase

Annual Inspections None (only States currently performing annual inspections are expected to continue) Based on discussions with stakeholders, States that currently conduct annual site assessments under the current TCR may no None (only States currently performing annual inspections are expected to continue) None No change IncreaseDocument initiating EO 12866 review

136 longer have the resources to continue the inspections and conduct quarterly monitoring under the Alternative option

Assessments None None Mandatory assessments are a new requirement Same as AIP option Decrease Decrease

Corrective Actions None None Mandatory corrective actions are a new requirement Same as AIP option Decrease Decrease

Public Notification –Monthly/NonAcute MCL Violations Reduction in available public information Possible PWS complacency Same as AIP option Less confusion (PN more in line with potential health risks)
PWSs resources used more efficiently Same as AIP option Unknown Unknown

Public Notification – Monitoring and Reporting Violations None None Increased stringency of PNs motivates PWSs to conduct required sampling Same as AIP option Decrease Decrease

Overall Decrease Decrease Notes: Detailed discussion of the rationale for determinations of potentia l risk for each rule component is presented in chapter 6 (section 6.2) of the Proposed RTCR EA (USEPA 2009a). Implementation activities consist of administrativ e activities by PWSs and States to implement the rule.Document initiating EO 12866 review

137 Assessment of potential changes in ri sk for monitoring components is an overall assessment. Potential changes (or static state) of risk for particular system sizes and types differ according to individual regulatory requirements and are di scussed in section 6.2 of the Proposed RTCR EA. Chapter 3 of the Proposed RTCR EA provides a detailed description of the regulatory components for all three regulator y scenarios, and this preamble provides additional discussion of the TCRDSAC process and the rationale underlying the struct ure of the regulatory options considered.

2. Changes in violation rate s and corrective actions The quantified portion of the benefits analysis focuses on several measures that contribute to the changes in risk expected under the pr oposed RTCR. Specifically, EPA modeled the predicted outcomes based on each regulatory option considered – baseline (current TCR), the AIP, and the Alternative option – in the form of estimates of non-acute violations for the current TCR and assessment triggers for the AIP and Alternative option; E. coli violations; and the number of corrective actions im plemented under each option. Th is section of the preamble includes six graphs (Exhibit VI-9 through Exhibit VI-14) that help to illustrate these endpoints. Evaluation of each of these endpoints informed EPA’s understanding of potential changes to the underlying quality of drinking water. In particular, the number of corrective actions performed has a strong relationship to potential improvements in wate r quality and public health. For a given rate of total coliform and E. coli occurrence, an increase in the number of corrective actions implemented leads to improved water quality. However, a reduction in sampling likely leads to a reduction in total coliform and E. coli positives being found, which in turn likely leads to a reduction in assessments and corrective ac tions being implemented. The number of total coliform and E. coli positives that are prevented, missed, or found under each regulatory option considered in comparison to those predicted under the current TCR results in estimates of annual non-acute and acute violations (c urrent TCR) and assessment triggers (AIP and Alternative options). Section 6.4 of the Proposed RTCR EA (U SEPA 2009a) presents a step-wise sensitivityDocument initiating EO 12866 review

138 analysis of the competing effects of additi onal protective activity (e.g., assessments and corrective actions) and decreased additional routine and repeat sampling of the regulatory alternatives compared to the curren t TCR. The results of this sensitivity analysis showed that for all categories of systems, more total coliform and E. coli positives are prevented than missed under both regulatory options. For each of the graphs presented in Exhibit VI-9 through Exhibit VI- 14, there are two main model drivers that affect the endpoints depicted: the total number of samples taken over time (including routine, additional rou tine, and repeat samples) and th e effect of corrective actions taken. When looking at the comparisons betwee n the TCR with the AIP across all PWSs, the overall effect of the total numbers of samples ta ken is negligible because the total number of samples predicted to be taken throughout th e period of analysis is almost the same (approximately 82 million samples) under both the T CR and AIP. For the Alternative option, the analysis predicts that approximately 87 million total samples are taken over the period of analysis. Exhibit VI-18 of this preamb le presents estim ated total numbers of samples taken over the 25-year period of analysis. Based on the relationships of total samples taken among the TCR, AIP, and Alternative options, the best way to interpret the graphs presented in this section is in a step-wise manner. The first comparison that should be made is between the current TCR and AIP options. Because similar total numbers of samples are ta ken under each option, the major effect seen in the graphs can be isolated to the effects th at implementation of corrective actions has on underlying occurrence and how that occurrence influences the endpoi nt in question (assessments,
E. coli MCL violations, and corrective actions). In each graph, this is depicted by a marked reduction in the endpoint under the AIP option co mpared to the current TCR option and is aDocument initiating EO 12866 review

139 reflection of overall better water quality. The second comparison can then be made of the Alternative option against the AIP option. In ea ch graph, the predicted results (assessments, E. coli MCL violations, and corrective actions) for th e Alternative option are above those for the AIP option and represent an additional benefit ov er the AIP option. This additional benefit is primarily a function of the additional diagnosti c abilities gained thr ough increased monitoring under the Alternative option, and is especially prominent in the early years of the analysis when all systems are required to monitor at least monthly. More detailed descriptions of each endpoint co nsidered in terms of the evaluation process described previously are provided in this section as they apply to the individual graphs in Exhibit VI-9 through VI-14. Each of the graphs shown in this section is presented first in nondiscounted terms, and then based on a discount rate of th ree percent to reflect th e reduced valuation of potential benefits over time, consis tent with the presentation of cost s in the section that follows. Graphs of benefits discounted using seven perc ent discounted rates are presented in Appendix B of the Proposed RTCR EA (USEPA 2009a). Exhibit VI-9 shows the effect (on average ac ross all PW Ss) of the AIP and the Alternative options on the annual number of non-acute violat ions (TCR) and assessment triggers (AIP and Alternative options) over time. The estimated reduction of annual assessment triggers (from the current TCR estimates of non-acute violations ) by approximately 1,000 events under the AIP option is a reflection of the improved water qualit y expected under the AIP option. A similar but smaller reduction in non-acute violations (Level 1 triggers) from the current TCR is seen under the Alternative option. The larg er initial estimate of assessmen t triggers followed by a higher steady state number for the Alternative option than seen under the AIP option reflects the diagnostic abilities provided by increased sampli ng under the Alternative option. The additionalDocument initiating EO 12866 review

140 triggers identified by increased sampling under the A lternative option tran slate into greater potential benefits than under the AIP option. Exhibit VI-10 shows the effect (on average acro ss all PWSs) of the AIP and the Alternative option with respect to E. coli violations found over the 25-year period of analysis in comparison to the current TCR. The overall reduction in annual E. coli violations under the AIP option of more than 100 events is a measure that should co rrelate closer to expected benefits (that is, reductions in adverse health outcomes) than non -acute events (as presented in Exhibit VI-9) because E. coli violations are a direct result of measurement of fecal contamination in water. A similar but smaller reduction is seen under the Al ternative option after steady state is achieved. The larger initial reduction followed by a higher steady state number for the Alternative option than seen under the AIP reflects the diagnos tic abilities provided by increased sampling under the Alternative option. The additional E. coli violations identified by increased sampling under the Alternative option translate into greater potential benefits than under the AIP. Exhibit VI-11 presents estimates over the 25-ye ar period of analysis of the increase in corrective actions (on average across all PWSs) attr ibutable to the regulatory options considered. Performance of these additional corrective actions is expected to result in the most direct benefits under the proposed RTCR. Because only the in cremental numbers of corrective actions estimated under the AIP and Alternative opti ons were modeled, the reference point for comparison to the current TCR is the base (zer o) line in the graph. The Proposed RTCR EA (USEPA 2009a) assumes that corrective actions are already being performed under the current TCR. Baseline corrective actions are taken into account by assuming only a modest incremental increase of 10 percent in implementation of e ffective corrective actions under both regulatory options considered.Document initiating EO 12866 review

141 Exhibit VI-11 indicates that mo re corrective actions are implemented under the Alternative option than under the AIP option. This is driv en, again, by the increased diagnostic power of more sampling and reflects additional potential benefits beyond those gained under the AIP option. Taken together, Exhibit VI-9 through Exhibit VI-11indi cate that the m odeled endpoints for the AIP and Alternative options predict positive be nefits in comparison to the current TCR; in particular, the Alternativ e option captures more benefits than the AIP option. Similar to the patterns seen in Exhibits VI-9 through VI- 11, for each of the discounted endpoints presented over time in Exhibits VI-12 though VI-14, the gra phs show that (on average across all PWSs) the Alternative option provides more benefit than the AIP, and both provide more benefit than the current TCR. These outcomes are consistent w ith the qualitative assessment of the benefits summarized in section VI.E.1. The major difference between the AIP option and Alternative option is the increased monitoring that is required under the Alternative option. The incr eased diagnostic ability of the extra samples taken under the Alternative option is seen in the large difference in the endpoint counts through the firs t several years in Exhibit VI-9 through Exhibit VI-14. Absent this effect, the Alternative option essentially m irrors the AIP option in the exhibi ts. Even though the predicted results (assessments, E. coli MCL violations, and co rrective actions) under the Alternative option are greater than the current TCR at first, the trend is due to initially finding more problems through monitoring. The increase d monitoring during the first several years under the Alternative option resu lts in a frontloading of bene fits at the beginning of the implementation period. The benefits, however, te nd to even out over time between the AIP and Alternative option as eligible systems qualify for less intense (quarter ly) monitoring under theDocument initiating EO 12866 review

142 Alternative option. However, th e Alternative option l eads to a greater number of assessments, E. coli MCL violations, and corrective actions than th e AIP option because all PWSs are required to sample no less than quarterly under the Alterna tive option while under the AIP option qualifying PWSs are permitted to sample at a minimum of once per year (more monitoring has the potential for more triggered assessments, corrective actions, and/or viola tions than less monitoring).

Exhibit VI-9 Estimates of Non-Acute Violations (T CR) and Level 1 Assessment Triggers (AIP and Alternative Option)

5,000 6,000 7,000 8,000 9,000 10,000 11,000 12,000 13,000 14,000

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25Non-Acute Violations (TCR) and Level 1 Assessment Triggers (AIPand Alt Options) (Nondiscounted Values)

Time (Years) TCR - Non-Acute Violations
AIP Option - Level 1 Assessment Triggers
Alt Option - Level 1 Assessment Triggers

Notes: X-axis begins at Y ear 4 after rule promulgation, wh ich is the first year of full implementation of the proposed RTCR (AIP option) or Alternative option. The annual rates of non-acute violations (TCR) and Level 1 assessment triggers (AIP and Alternative option) as predicted by the model reach a steady state beginning in approximately Year 9, by which time PWSs that are expected to meet the criteria for reduced monitoring begin reduced monitoring, and the distribution of PWSs the monitor monthl y, quarterly, and annually is assumed to remainDocument initiating EO 12866 review

143 relatively constant. Estimates represent the annual number of assessment triggers found by each option and the non-acute viol ations found under the TCR. Source: Proposed RTCR occurrence model output.

Exhibit VI-10 Estimates of Acute Violations (TCR) and E. coli MCL Violations (AIP and Alternative Options)

400 500 600 700 800 900 1,000 1,100 1,200 1,300

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25Acute Violations (TCR) andE. coliMCL Violations (AIP and AltOptions) (Nondiscounted Values)

Time (Years) TCR - Acute Violations

AIP Option - E. coli MCL Violations

Alt Option - E. coli MCL Violations

Notes: X-axis begins at Y ear 4 after rule promulgation, wh ich is the first year of full implementation of the proposed RTCR (AIP option) or Alternative option. The annual rates of acute violations (TCR) and E. coli MCL violations (AIP and Alte rnative option) as predicted by the model reach steady state in approximately Y ear 9, by which time PWSs that are expected to meet the criteria for reduced monitoring begin re duced monitoring, and the distribution of PWSs the monitor monthly, quarterly, and annually is assu med to remain relatively constant. Estimates represent the annual number of acute viol ations found by each option and the TCR. Source: Proposed RTCR occurrence model output.

Exhibit VI-11 Estimates of Corrective ActionsDocument initiating EO 12866 review

144 500 600 700 800 900 1,000 1,100 1,200 1,300 1,400 1,500 1,600

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25Corrective Acitons (Nondiscounted Values)

Time (Years) AIP Option - Corrective Actions
Alt Option - Corrective Actions

Notes: X-axis begins at Y ear 4 after rule promulgation, wh ich is the first year of full implementation of the proposed RTCR (AIP option) or Alternative option. The annual rates of corrective actions as predicted by the model r each a steady state beginning approximately in Year 9, by which time PWSs that are expected to meet the criteria for reduced monitoring begin reduced monitoring, and the distribution of PWSs the monitor monthly, quarterly, and annually is assumed to remain relatively constant. All corrective actions perfor med are in addition to activity under the current TCR, which does not require corrective actions. Therefore the current TCR is not included in this graph. Source: Proposed RTCR occurrence model output.

Exhibit VI-12 Discounted Estimates of Non-Acut e Violations (TCR) and Level 1 Assessment Triggers (AIP and Alternativ e Options) (three percent discount rate)Document initiating EO 12866 review

145 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 10,000 11,000 12,000 13,000

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25Non-Acute Violations (TCR) and Level 1 Assessment Triggers (AIPOption and Alt Option) (Present Value, 3% Discount Rate)

Time (Years) TCR - Non-Acute Violations
AIP Option - Level 1 Assessment Triggers Alt Option - Level 1 Assessment Triggers

Notes: X-axis begins at Y ear 4 after rule promulgation, wh ich is the first year of full implementation of the proposed RTCR (AIP option) or Alternative option. The annual rates of non-acute violations (TCR) and Level 1 assessment triggers (AIP and Alternative option) as predicted by the model reach a steady state beginning in approximately Year 9, by which time PWSs that are expected to meet the criteria for reduced monitoring begin reduced monitoring, and the distribution of PWSs the monitor monthl y, quarterly, and annually is assumed to remain relatively constant. Estimates represent the annual number of assessment triggers found by each option and the non-acute viol ations found under the TCR. Source: Proposed RTCR occurrence model output.
Exhibit VI-13 Discounted Estimates of Ac ute Violations (TCR) and E. coli Violations (AIP and Alternative Op tions) (three percent discount rate)Document initiating EO 12866 review

146 0 100 200 300 400 500 600 700 800 900 1,000 1,100 1,200

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25Acute Violations (TCR) andE. coliMCL Violations (AIP Option andAlt Option) (Present Value, 3% Discount Rate)

Time (Years) TCR - Acute Violations

AIP Option - E. coli MCL Violations

Alt Option - E. coli MCL Violations

Notes: X-axis begins at Y ear 4 after rule promulgation, wh ich is the first year of full implementation of the proposed RTCR (AIP option) or Alternative option. The annual rates of acute violations (TCR) and E. coli MCL violations (AIP and Alte rnative option) as predicted by the model reach steady state in approximately Y ear 9, by which time PWSs that are expected to meet the criteria for reduced monitoring begin re duced monitoring, and the distribution of PWSs the monitor monthly, quarterly, and annually is assu med to remain relatively constant. Estimates represent the annual number of acute vi olations found by each option and the TCR. Source: Proposed RTCR occurrence model output.
Exhibit VI-14 Discounted Estimates of Corrective Actions (three percent discount rate)Document initiating EO 12866 review

147 0 100 200 300 400 500 600 700 800 900 1,000 1,100 1,200 1,300 1,400

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25Corrective Acitons (Present Value, 3% Discount Rate)

Time (Years) AIP Option - Corrective Actions
Alt Option - Corrective Actions

Notes: X-axis begins at Y ear 4 after rule promulgation, wh ich is the first year of full implementation of the proposed RTCR (AIP option) or Alternative option. The annual rates of corrective actions as predicted by the model r each a steady state beginning in approximately Year 9, by which time PWSs that are expected to meet the criteria for reduced monitoring begin reduced monitoring, and the distribution of PWSs the monitor monthly, quarterly, and annually is assumed to remain relatively constant. All corrective actions perfor med are in addition to activity under the current TCR, which does not require corrective actions. Therefore the current TCR is not included in this graph. Source: Proposed RTCR occurrence model output.
The quantified portion of the benefits analysis focuses on several measures that contribute to the reductions in risk exp ected under the proposed RTCR. Specifically, EPA modeled the predicted outcomes based on each regulatory option considered – baseline (current TCR), theDocument initiating EO 12866 review

148 AIP, and the Alternative option – in the form of estimates of non-acute violations for the current TCR and assessment triggers for the AIP and Alternative options; E. coli violations; and the number of corrective actions implemented under each option. The previous discussion presented a summary of the estimated impact s of both regulatory options considered in comparison to the curren t TCR. Evaluation of each of these outcomes informed EPA’s understanding of potential changes to the underlying quality of drinking water. In particular, the number of co rrective actions performed has a strong relationship to potential improvements in water quality and public health . For a given level of total coliform and E. coli occurrence, an increase in the number of corrective actions imple mented leads to improved water quality. However, a reduction in sampling leads to a reduction in total coliform and E. coli positives being found, which in turn leads to a reduction in asse ssments and corrective actions being implemented. The number of total coliform and E. coli positives that are prevented, missed, or found under each regulatory option consid ered in comparison to those predicted under the current TCR results in estimates of annual non- acute and acute violati ons (current TCR) and assessment triggers (AIP and Alternative op tion). Section 6.4 of the Proposed RTCR EA (USEPA 2009a) presents a step-wise sensitivity analysis of the competing effects of additional protective activity (e.g., assessments and correctiv e actions) and decreased additional routine and repeat sampling of the regulatory al ternatives compared to the current TCR. The results of this sensitivity analysis showed that for all cate gories of systems, mo re total coliform and E. coli positives are prevented than missed.
3. Nonquantifiable benefits

a. Potential decreased incidence of endemic il lness from fecal cont amination, waterborne pathogens, and associated outbreaks. As discussed in section VI of this preamble and chapter 2Document initiating EO 12866 review

149 of the Proposed RTCR EA (USEPA 2009a), bene fits from the proposed RTCR may include avoidance of a full range of health effects fr om the consumption of fecally contaminated drinking water, including the following: acute and chronic illness, endemic and epidemic disease, waterborne disease outbreaks, and death. Also, since fecal c ontamination may contain waterborne pathogens incl uding bacteria, viruses, and parasitic protozoa, in general, a reduction in fecal contamination should reduce the risk from these other contaminants. EPA recognizes that the EPA-approved standard methods available for E. coli do not typically identify the presence of the pathogenic E. coli strains, such as E. coli O157:H7. Thus, E. coli occurrence, as used in this EA, serves as an indication of fecal contamination but not necessarily pathogenic contamination. See also discussion in secti ons III.A.2 and III.A.9 of this preamble. EPA was unable to quantify the cases of morbidity or mortal ity avoided because there are insufficient data reporting the co -occurrence of fecal indicator E. coli and pathogenic organisms in a single water sample, and becau se the available fecal indicator E. coli data from the Six-Year Review 2 dataset were limited to presence-absence data. Instead, EPA estimated changes in total coliform and fecal indicator E. coli occurrence (for systems serving 4,100 or fewer people) and changes in number of corrective actions (for systems serving greater than 4,100 people) as measures of reduced risk. As discussed prev iously, the assessments and corrective actions required under the RTCR will help lead to a decrease in total coliform and E. coli occurrence in drinking water. Since fecal contamination can contain waterborne pathogens including bacteria, viruses, and parasitic protozoa, in general, a reduction in feca l contamination should also reduce the potential risk from these other contaminants and the associated primary and secondary endemic disease burden, both acute and chronic.Document initiating EO 12866 review

150 b. Other nonquantifiable benefits. Other nonquantified health benefits may include decreased incidence of outbreaks, epidemic illness and deaths associated with fecal contamination and/or waterborne pathogens. The nonquantified non-health benefits include increased knowledge regarding system operation, accelerated maintenance and repair, avoided costs of outbreaks, and reduc tions in averting behavior. By requiring PWSs to conduct assessments that meet minimum elements focused on identifying sanitary defects in response to triggers for total coliform- or E. coli -positive samples, the proposed RTCR increases the likelihood that PW S operators, in particular those of systems triggered to conduct assessments and correctiv e action, will develop further understanding of system operations and improve and practice preventive maintenance compared to the current TCR, which does not require PWSs to pe rform assessments and corrective action. Another non-quantified benefit is that systems may choose co rrective actions that also address other drinking water contaminants. For example, correcting for a pathway of potential contamination into the distribution system can possibly also mitigate a variety of other potential contaminants. Due to the lack of data av ailable on the effect of corrective action on contamination entering through distribution syst em pathways, EPA has not quantified such potential benefits. In addition to benefits from additional preventive maintenance, some systems may accelerate their capital replacement fund investment s in response to early identification of impending problems with large capital components. Although such capital investment will eventually occur anyway, earlier investment may ensure that problems are addressed in a preventive manner and may preclude some decrease in protection that might have occurredDocument initiating EO 12866 review

151 otherwise. At the very leas t, the increased operator awaren ess is expected to reduce the occurrence of unplanned capital expe nditures in any given year. Another major non-health benefit is the avoide d costs associated with outbreak response. Outbreaks can be very costly for both the PWS and the community in which they occur. Avoided outbreak response costs include such co sts as issuing public h ealth warnings, boiling drinking water and providing alternative supplies, remediation and re pair, and testing and laboratory costs. Reduced total coliform occu rrence resulting from th e proposed RTCR may also lead to a reduction of costs associated with boil-water orders, which some States require following non-acute violations under the current TCR. Taken together, these expenses can be quite significant. For example, an analysis of the economic impacts of a waterborne disease outbreak in Walkerton, Ontario (population 5,000) estimated the economic impact, excluding medically related costs, to be over $45.9 m illion in 2007 Canadian dollars (approximately 42.8 million 2007 US dollars) (Livernois 2002). The au thor of the study believed that this was a conservative estimate. In addition, the proposed RTCR may also redu ce uncertainty rega rding drinking water safety, which may lead to reduced costs for aver ting behaviors. Averti ng behaviors include the use of bottle water and point-of-use devices. Th is benefit also includes the reductions in time spent on averting behavior such as the time spent obtaining alternative water supplies.
F. Anticipated Costs of the Proposed RTCR To understand the net impacts of the proposed RT CR on public water systems and States in terms of costs, EPA first used available data, information, and best professional judgment to characterize how PWSs and States are currently implementing the current TCR. Then, EPA considered the net change in costs that result from implementing the AIP or Alternative optionsDocument initiating EO 12866 review

152 as compared to the costs of continuing with th e current TCR. The objective was to present the net change in costs resulting from revisions to the current TCR rather than absolute totals. More detailed information on cost estimates are describe d in the sections that follow and a complete discussion can be found in chapter 7 of the Proposed RTCR EA (USEPA 2009a). A detailed discussion of the proposed revisions is lo cated in section III of this preamble.
1. Total annualized present value costs To compare cost of compliance act ivities for the three regulatory scenarios, the year or years in which all costs are expended are determined a nd the costs are then calculated as a net present value. For the purposes of this EA, one-time a nd yearly costs were proj ected over a 25-year time period to allow comparison with ot her drinking water regulations usi ng the same analysis period. For this analysis, the net pres ent values of costs in 2007 dolla rs are calculated using discount rates of three percent and seven percent. Exhibit VI-15 summarizes the comparison of to tal and annualized present value of the net change difference in cost from the baseline for ea ch of the three regulatory scenarios (current TCR, AIP option, and Alternative option). A continuation of the curren t TCR will result in no net change in costs. The net change in mean annualized present value national costs of the AIP option is estimated to be approximately $14 million (M) using either a three percent or seven percent discount rate. The net change in mean annualized present value national costs for the Alternative option are estimated to be approxima tely $27M using a three percent discount rate and $30M using a seven percent discount rate. Gi ven these low net costs, both options are below the threshold of a “significant regulatory action” under Executive Order 12866 as discussed in chapter 9 of the Proposed RTCR EA (USEPA 2009a) and in section VII.A of this preamble.Document initiating EO 12866 review

153 Under the AIP option, public water systems are es timated to incur greater than 90 percent of the proposed revised rule’s net annu alized present value costs. St ates are expected to incur the remaining costs. Exhibit VI-16 presents the comparison of total and net change in annualized present value costs by rule com ponent. The ta ble shows that routine monitori ng and corrective action costs are the most significant contributors to the net incr ease in costs for PWSs under both the AIP and Alternative options. For States, revising sampling plans contribute mo st to the cost increase. For both PWSs and States, a net decrease in costs associ ated with PN requirements helps to offset the total net cost increase.

Exhibit VI-15 Comparison of Total and Net Chan ge in Annualized Present Value Costs ($Millions, 2007$)
PWSs State Total PWSs State Total 3% Discount Rate 7% Discount Rate
TCR – Total $ 185 $ 0.9 $ 186 $ 178 $ 0.9 $ 179
AIP – Total $ 199 $ 1.1 $ 200 $ 191 $ 1.3 $ 192 AIP - Net Change $ 14 $ 0.1 $ 14 $ 13 $ 0.4 $ 14 AIP - Percent Change 7% 16% 7% 7% 48% 8% Alternative option - Total $ 212 $ 1.2 $ 213 $ 207 $ 1.5 $ 209 Alternative option - Net Change $ 27 $ 0.3 $ 27 $ 29 $ 0.6 $ 30 Alternative option - Percent Change 15% 32% 15% 16% 67% 17% Note: Detail may not add due to independent rounding. Source: Proposed RTCR EA (USEPA 2009a).Document initiating EO 12866 review

154 Exhibit VI-16 Comparison of Total and Net Chan ge in Annualized Present Value Costs by Rule Component ($Millions, 2007$)

Note: Assumes a certain level of assessment activity already occurs under the current TCR, as discussed in chapter 7 of the Proposed RTCR EA (USEPA 2009a).Document initiating EO 12866 review

155 Source: Proposed RTCR EA (USEPA 2009a).
2. PWS costs Like the current TCR, the propos ed RTCR applies to all PWSs. Exhibit VI-17 presents the total and net change in annualized costs to PW Ss by size and type for the three regulatory options. No net change in cost s will result from a continua tion of the current TCR. Among PWSs serving 4,100 or fewer people, looking at the three percent discou nt rate, the largest increase in aggregate net costs is incurred by the TNCWSs serving 100 or fewer people under either the AIP ($5.1M) or Alternative option ($13 .4M) because of the large number of systems. On a per system basis, this translates to a net annualized present value increase of approximately $83 per system under the AIP and $217 per system under the Alternative op tion for the TNCWSs serving 100 or fewer people. As described in se ction VII.C of this preamble, none of the small TNCWSs are estimated to have costs that are gr eater than or equal to three percent of their

revenue. The total net change in national annualized present value costs for all PWSs serving greater than 4,100 people (approximately $6M using three percent discount rate) is the same under the AIP and Alternative option. This is expected because the provisions fo r PWSs serving greater than 4,100 are the same under either option. Mon itoring requirements for PWSs serving greater than 4,100 people remain essentially unchanged under either the AIP or A lternative option. The observed overall net increase in costs for PWSs serving greater than 4,100 people is driven primarily by the requirements to conduct assessments and to correct any sanitary defects that are found.
Exhibit VI-17 Total and Net Change in Annualized Costs to PWSs by PWS Size and Type ($Millions, 2007$)Document initiating EO 12866 review

156 Note: Detail may not add due to independent rounding. Because only the incremental costs of some rule components are considered as part of th e cost analysis, references to "total" costs in this exhibit do not refer to the complete cost s for regulatory implement ation but only to the specific costs considered to cal culate net changes in costs. Source: Proposed RTCR cost model.

a. Rule implementation and annual administration. Under the AIP and Alternative options, all PWSs subject to the proposed RTCR incur one-t ime costs that include time for staff to read the RTCR, become familiar with its provisions, an d to train employees on rule requirements. No additional implementation burden or costs will be incurred by PWSs if the current TCR option is maintained. Under the AIP and Alternative op tions, all PWSs subject to the proposed RTCR perform additional or transitional implementation activities. Based on previous experience with rule implementation, EPA estimated that PWSs require a total of f our hours to read andDocument initiating EO 12866 review

157 understand the rule, and a total of eight hours to plan and as sign appropriate personnel and resources to carry out rule activities.
b. Revising sampling plans. Under the AIP and Alternative options, all PWSs subject to the proposed RTCR incur one-time costs to revise existing sampling plans to identify sampling locations and collection schedules that are representative of water throughout the distribution system. Under the TCR, no additional burden or costs are expected to be incurred by PWSs to revise sampling plans, as these PWSs are already collecting total coliform samples in accordance with a written sampling plan. Based on previous experience, EPA estimated that PWSs require 2-8 hours to revise their sampli ng plan, depending on PWS size.

c. Monitoring. Monitoring costs for PWSs are calcula ted by multiplying the total numbers of routine, additional routine, and repeat sa mples required under the current TCR, AIP, and Alternative options by the monitori ng costs per sample. Under the AIP, the increased stringency to qualify for reduced monitoring results in more routine samples being taken over time (fewer PWSs are on reduced monitoring). For the Alternat ive option, this effect is combined with the requirement that all PWSs start the impleme ntation period on monthly monitoring. The Alternative option also prohibits annual monitoring, resulting in a greater increase in the number of routine samples compared to the AIP option. Th e resulting increases in costs due to increased monitoring are reflected in the routine monitoring costs. The overall reductions in the numbers of addi tional routine samples required under the AIP and Alternative option resu lt in reduced costs. Cost reductio ns are greater under the Alternative option than under the AIP because under the A lternative option all PWSs start on monthly monitoring and are not required to take additional routine sa mples during that period.Document initiating EO 12866 review

158 Under the current TCR, PWSs serving 1,000 or fe wer people take four repeat samples at and within five service connections upstream and do wnstream of the initia l total coliform positive occurrence location over the course of 24 hours following the event. The number of repeat samples required for PWSs serving more than 1,000 people is the same under the current TCR and the AIP and Alternative options. Exhibit VI-18 summarizes the cumulative number of samples taken by PWS size and category for routine, additional, and repeat m onitoring under the TCR, AIP, and Alternative option over the entire 25-year pe riod of analysis. Under the cu rrent TCR option, approximately 82.1 million samples are taken over the 25-year peri od of analysis compared to approximately 82.2 million samples under the AIP option and approximately 87.9 million samples under the Alternative option (less than 10 percent more than current TCR option). Appendix A of the Proposed RTCR EA (USEPA 2009a) presents add itional information on the number of samples taken each individual year during the analysis period. The annualized net present value total and net ch ange cost estimates for PWSs and States to perform monitoring under the TCR, AIP, and Alternative options and are presented in Exhibit
VI-19.
Exhibit VI-18 Cumulative Number of Samples over 25-Year Period of Analysis for Baseline (TCR) and Regulatory Alternatives (AIP and Alternative option)Document initiating EO 12866 review

159Document initiating EO 12866 review

160 Exhibit VI-19 Annualized National PWS and State Monitoring Cost Estimates ($Millions, 2007$) 3% discount rate 7% discount rate TCR - Total $ 179.57 $ 172.57 AIP - Total $ 180.65 $ 173.46 AIP - Net Change $ 1.08 $ 0.90 AIP - Percent Change 0.60% 0.52% Alternative option – Total $ 192.53 $ 187.53 Alternative option - Net Change $ 12.96 $ 14.96 Alternative option - Percent Change 7.22% 8.67% Note: Detail may not add due to independent rounding. Source: Proposed RTCR EA (USEPA 2009a) The overall estimated increase in monitoring co sts seen under the AIP is driven by increases in routine monitoring due to stricter requirement s to qualify for reduced monitoring. However, this is mostly offset by reductions in additiona l routine and repeat mon itoring required under the revised regulations. For the A lternative option, the requirement for all PWSs to sample on a monthly basis at the beginning of rule implementa tion results in a much larger cost differential that is only partially offset by reduced costs due to reductions in additional routine monitoring requirements.
d. Site inspections. Under the AIP, any PWS on an annual monitoring schedule is required to also have an annual site in spection conducted by the State or State-designated third party. A voluntary Level 2 site assessment can also satisfy the site inspection requirement. For years in which the State performs a sanitary survey (at least every five years for NCWSs and three years for CWSs), a sanitary survey pe rformed during the same year can also be used to satisfy this requirement. EPA uses the same assumptions to estimate costs associated with site visits for both the AIP and Alternative optionsDocument initiating EO 12866 review

161 e. Assessments. Annualized cost estimates for Level 1 and Level 2 assessments under the TCR, AIP, and Alternative options are calcul ated by multiplying the number of assessments estimated by the predictive modeling (summarized in Exhibit 7.13) by the un it costs presented in chapter 7 of the Proposed RTCR EA (USEPA 20 09a). Appendix A of the Proposed RTCR EA (USEPA 2009a) provides a detaile d breakout of the number of Level 1 and Level 2 assessments estimated by the occurrence model. Annua lized cost estimates are presented in Exhibit VI-20.
Exhibit VI-20 Annuali zed National PWS Costs Estimate s for Assessment Activity (current TCR) and Level 1 and Level 2 Assessments (A IP and Alternative Options) ($Millions, 2007$)
3% discount rate 7% discount rate

TCR - Total 1.13 $ 1.08 $ AIP - Total 1.63 $ 1.57 $ AIP - Net Change 0.50 $ 0.49 $ Alternative Option - Total 1.73 $ 1.69 $ Alternative Option - Net Change 0.60 $ 0.60 $

TCR - Total 0.70 $ 0.68 $ AIP - Total 0.90 $ 0.88 $ AIP - Net Change 0.20 $ 0.20 $ Alternative Option - Total 1.23 $ 1.27 $ Alternative Option - Net Change 0.52 $ 0.60 $ Level 1 Assessments

Level 2 Assessments

Note: EPA estimated the level of asse ssment activity conducted by PWSs thought to occur under the cu rrent TCR, as discussed in chapter 7 of Proposed RTCR EA (USEPA 2009a) Detail may not add due to independent rounding. Source: Proposed RTCR cost model, de scribed in chapter 7 of the Proposed RTCR EA (USEPA 2009a) Under the AIP, the overall number of assessments (both Level 1 and Level 2) decreases as a function of reduced fecal indicato r occurrence over time. However, PWS costs increase slightly due to the higher unit cost of performing assessm ents compared to exis ting practices under the TCR. The total net change in co st is estimated to be positive.Document initiating EO 12866 review

162 The overall number of assessments is larger under the Alternative option compared to the AIP option. This is a result of the initial monthly monitoring requirements for all PWSs under this analysis. The modeling re sults indicate that a greater nu mber of samples early in the implementation period results in more positive sa mples and associated assessments despite the predicted long term reductions in occurrence as informed by the assumptions. This increase in total assessments performed, combined with th e higher unit cost of performing assessments compared to existing practices under the TCR, re sults in a higher net cost increase for the Alternative option than under the AI P. The total net change in co st for the Altern ative option is estimated to be positive, and nearly twice as high as under the AIP opti on. See Exhibit 7.15 of the Proposed RTCR EA (USEPA 2009a). f. Corrective actions. Under the AIP and Alternative options, all PWSs are required to correct sanitary defects found through the perfor mance of Level 1 or Level 2 assessments. For modeling purposes, EPA estimated the net change in the number of corrective actions performed under the AIP and Alternative options. EPA a ssumed that any corrective actions based on a positive source water sample are accounted for under the GWR and not under the proposed RTCR. Based on discussions with State represen tatives, EPA assumed that additional corrective actions are performed for only 10 percent of th e assessments undertaken as a result of the proposed RTCR representing the net in crease over the current TCR. To estimate the costs incurred for the correction of sanitary defects, EPA assumed the percent distribution of PWSs that perform different types of corrective acti ons as presented in the compliance forecast shown in Exhibit VI-21 based on best pr ofessional judgm ent. . The compliance forecast presented in this section was informed by discussions of the TCRDSAC Technical Work Group and focuses on broad ca tegories of types of corrective actionsDocument initiating EO 12866 review

163 anticipated. EPA used best professional j udgment to make simplifying assumptions on the distribution of these categories th at are implemented by different systems based on size and type of system. For each of the categories listed, a PWS is assumed to take a specific action that falls under that general category. Detailed complia nce forecasts showing the specific corrective actions used in the cost analysis are provide d in Appendix D of the Proposed RTCR EA (USEPA 2009a), along with summary tables of the unit cost s used in the analysis. Each corrective action in the detailed compliance forecast is also assi gned a representative unit cost. Detailed descriptions of the derivation of unit costs are provided in the Technology and Cost Document for the Proposed Revised Total Coliform Rule (USEPA 2009b).
Exhibit VI-21 Compliance Forecast for Corrective Actions based on Level 1 and Level 2 Assessments

As shown in the compliance forecast in Exhibit VI-21, EPA estimated that corrective actions found through Level 1 assessm ents result in corr ective actions that fo cus more on transient solutions or training (columns A and B) than on permanent fixes to the PWS. However, in the case of flushing, EPA assumed that in a majority of instances, PWSs implement a regularDocument initiating EO 12866 review

164 flushing program as opposed to a single flushing, based on EPA and stakeholder best professional judgment. Level 1 assessments generally are less involved than Level 2 assessments and may result in finding less complex problems. Corrective actions taken as a result of Level 2 assessments are expected to find a higher proportion of structural/technical issues (columns C-K) resulting in material fixes to the PWSs and distribution system. In addition, EPA ran tw o sensitivity analyses to assess the potential impacts of different distributions within the compliance forecast. Results of the sensitivity analyses are presented in section 7.7 of the Proposed RTCR EA (USEPA 2009a). As indicated in the more detailed analysis pr esented in chapter 7 of the Proposed RTCR EA (USEPA 2009a), PWSs also in cur reporting and recordkeeping burden to notify the State upon completion of each corrective action. PWSs may also consult with the State or with outside parties to determine the appropriate co rrective action to be implemented. Annualized cost estimates for PWSs to pe rform corrective acti ons are estimated by multiplying the number of Level 1 and Level 2 corrective actions estimated by the predictive model, (i.e., 10 percent of Level 1 and Leve l 2 assessments) by the percentages in the compliance forecast and unit costs of correc tive actions and associated reporting and recordkeeping. The total a nd net change costs of corre ctive actions are shown in Exhibit VI-22.
Exhibit VI-22 Annuali zed PWS Cost Estimates for Corrective Actions based on Level 1 and Level 2 Assessments ($Millions, 2007$) 3% discount rate 7% discount rate Corrective Actions based on Level 1 Assessments TCR – Total $ - $ -
AIP – Total $ 9.17 $ 7.77 AIP - Net Change $ 9.17 $ 7.77 Alternative option - Total $ 9.39 $ 8.01Document initiating EO 12866 review

165 Alternative option - Net Change $ 9.39 $ 8.01 Corrective Actions based on Level 2 Assessments TCR – Total $ - $ -
AIP – Total $ 2.72 $ 2.41 AIP - Net Change $ 2.72 $ 2.41 Alternative option - Total $ 3.53 $ 3.36 Alternative option - Net Change $ 3.53 $ 3.36 Note: Detail may not add due to independent rounding. Source: Proposed RTCR cost model, descri bed in chapter 7 of the Proposed RTCR EA (USEPA 2009a). The differences in the net change in correctiv e action costs between the AIP and Alternative option are a function of the differe nt number of assessments estim ated to be performed in the predictive model.

g. Public notification. Estimates of PWS unit costs for PN are derived by multiplying PWS labor rates from section 7.2.1 of the Pr oposed RTCR EA (USEPA 2009a) and burden hour estimates derived from the Draft Information Collection Reques t for the Public Water System Supervision Program (USEPA 2008c). PWS PN unit cost estimates are presented in Exhibit 7.19 of that document. Total and net change in a nnualized net present value co sts for PN are estimated by multiplying the model estimates of PWSs with acute (Tier 1 public notification) and non-acute (Tier 2 public notificatio n) violations by the PWS unit costs for performing PN activities. The proposed RTCR cost model assumed that all violat ions are addressed following initial PN, and no burden is incurred by PWSs for repeat notification. Annualized total and net cost estimates for PWSs and States to perform public notifica tion under the TCR, AIP, and Alternative options are presented in Exhibit VI-23.Document initiating EO 12866 review

166 Exhibit VI-23 Annualized National PWS Cost Estimates for Public Notifica tion ($Millions, 2007$)
3% discount rate 7% discount rate TCR - Total 3.75 $ 3.60 $ AIP - Total 0.26 $ 0.26 $ AIP - Net Change (3.49) $ (3.35) $ AIP - Percent Change -93% -93% Alternative Option - Total 0.34 $ 0.35 $ Alternative Option - Net Change (3.41) $ (3.26) $ Alternative Option - Percent Change -91% -90% Note: Detail may not add due to independent rounding. Source: Proposed RTCR cost model, de scribed in chapter 7 of the Proposed RTCR EA (USEPA 2009a). A significant reduction in costs is estimated due to the elimination of Tier 2 public notification for non-acute/monthly MCL violations under both the AIP and Alternative options.
3. State costs EPA estimated that all States nationally together incur a net increase in national annualized present value costs under the AIP option of $0.1M (at three percent disc ount rate) and $0.4M (at seven percent discount rate) and under the Alternative option of $0.3M (at three percent discount rate) and $0.6M (at seven percent discount ra te). State costs include implementing and administering the rule, revising sampling plans, reviewing sampling results, conducting site inspections, reviewing completed assessment fo rms, tracking correctiv e actions, and public notifications. The following sections summarize the key assumptions that EPA made to estimate the costs of the proposed RTCR. Chapter 7 of the Proposed RTCR EA (USEPA 2009a) provides a description of the analysis.

a. Rule implementation and annual administration. States incur administrative costs to implement the proposed RTCR. These implementa tion costs are not direc tly required by specific provisions of the proposed RTCR alternatives, bu t are necessary for States to ensure the provisions of the proposed RTCR are properly carried out. States need to allocate time for theirDocument initiating EO 12866 review

167 staff to establish and maintain the programs necessary to comply with the proposed RTCR, including developing and adopting State regulations and modifying data management systems to track new required PWS reports to the States. Time requirements for a variety of State agency activities and responses are es timated in this EA. Exhibit 7.4 of the Proposed RTCR EA (USEPA 2009a) lists the activitie s required to revise the program following promulgation of the proposed RTCR along with their respective costs and burden including, for example, the net change in State burden associated with tracki ng the monitoring frequencies of PWSs (captured under “modify data management systems”). EPA estimated a net increase in national annualized cost estimates incurred by States for rule impl ementation of $0.18M (three percent discount rate) and $0.26M (seven percent discount rate) under either the AIP or the Alternative option. Because time requirements for implementation and annual administration activities vary among State agencies, EPA recognizes that the unit costs used to develop national estimates may be an over- or under-estimate for some States.
b. Revising sampling plans. Under the AIP and Alternative op tions, States are expected to incur one-time costs to review sampling plans and recommend any revisions to PWSs. Under the TCR option, no additional burden or costs are incurred by States to review sampling plans, as these PWSs’ sampling plans have already been re viewed and approved. State costs are based on the number of PWSs submitting revised sampling plans to PWSs each year. Based on previous experience, EPA estimated that States require on e to four hours to review revised sampling plans and provide any necessary revisions to PWSs , depending on PWS size. EPA estimated a net increase in national annualized cost estimates incurred by States for revising sampling plans of $0.42M (three percent discount rate ) and $0.59M (seven percent disc ount rate) under either the AIP or the Alternative option.Document initiating EO 12866 review

168 c. Monitoring. EPA assumed that States incur a mont hly 15-minute burden to review each PWS’s sample results under the cu rrent TCR. This estimate reflects the method used to calculate reporting and recordkeeping burde n under the current TCR in the Draft Information Collection Request for the Microbial Rules (USEPA 2008a). Because the ex isting method calculates cost on a per PWS basis and the total number of PWSs is the same for cost modeling under the TCR and both proposed RTCR options, the net change in costs for reviewing monitoring results is assumed to be zero for the AIP and Alternative options. Specific actions by States related to positive samples are accounted for under the actions required in response to those samples.
d. Site inspections. Under the AIP option, any PWS on an annual monitoring schedule is required to also have an annual site inspecti on conducted by the State or State-designated third party. A voluntary Level 2 site assessment can al so satisfy the site insp ection requirement. In many cases a sanitary survey performed during the same year can also be used to satisfy this requirement. Although similar site inspections are not currently required under the current TCR, discussions with States during the TCRDSAC pr oceedings revealed that some do, in fact, conduct such inspections for PWSs on annual mon itoring schedules. Because of the high cost for an annual site inspection by a State, for this analysis EPA assumed th at no States choose to conduct annual site inspections unless they al ready do so under the current TCR. Under the Alternative option, PWSs are required to sa mple no less than quarterly and under that requirement may elect to forgo annual site insp ections (especially in cases where the State performs or subsidizes the additional monitori ng for PWSs that were previously monitoring annually) since they are not required. However, due to a lack of data on the potential for discontinuing annual site visits under the A lternative option, the proposed RTCR cost model does not calculate the potential cost reductions for discontinui ng site inspections under theDocument initiating EO 12866 review

169 Alternative option. This leads to a potential overestimate of costs for the Alternative option (i.e., a cost savings may be realized for some States). For overall costing purposes, no net State or PWS costs are assumed for annual monitoring site inspections under the AIP option or Alternative option.

e. Assessments. States incur burden to review comple ted assessment forms required to be filed by PWSs under the AIP and Alternative opti ons. Although specific forms are not required under the current TCR, EPA assumes that PWSs e ngage in some form of consultation with the State. For costing purposes, EPA assumes that the level of effort required for such consultations under the current TCR is the same as that whic h would be required to review assessment forms under the AIP and Alternative options. State co sts are based on the number of PWSs submitting assessment reports. EPA estimated that State burden to review PWS assessment forms ranges from one to eight hours depending on PWS size and type, as well as the level of the assessment. This burden includes any time required to consult with the PWS about the assessment report. Although some States may choose to conduct assessments for their PWSs, EPA does not quantify these costs. The costs are attributed to PWSs that are responsible for insuring that assessments are done. The reduction in the number of assessments under the AIP option compared the current TCR (as explained in chapter 7 of the Proposed RTCR EA (USEPA 2009a), based on discussions with the technical workgroup supporting the advisory committee, EPA assumes a certain level of assessment activity already occurs under the current TCR) is estimated to translate directly to a small national cost savings ($0.08M at either th ree or seven percent discount rate) while the increase in the number of assessments under the Alternative option is estimated to translate directly to a national cost incr ease ($0.03M at three percent discount rate and $0.07M at sevenDocument initiating EO 12866 review

170 percent discount rate). Under the AIP, the overall number of assessments decreases as a function of reduced occurrence over time. The overa ll number of assessments is higher under the Alternative option as a result of the initial monthly monitoring requirements for all PWSs. f. Corrective actions. For each corrective action perfor med under AIP and Alternative option, States incur recordkeepi ng and reporting burden to review and coordinate with PWSs. This includes burden incurred from any optional c onsultations States may conduct with PWSs or outside parties to determine the appropriate corr ective action to be implemented. The number of corrective actions under either the AIP or Alternative option is estimated to translate to a national net annualized cost increase to States of $0.01M at ei ther three or seven percent discount rate

g. Public notification. Under the TCR, AIP, and Alternative options, States incur recordkeeping and reporting burden to provide consultation, review th e public notification certification, and file the report of the violation. A si gnificant reduction in costs is estimated due to the elimination of Tier 2 public notification for non-acute MC L violations under the AIP and Alternative options. Because St ate costs are calculated on a pe r-violation basis, State costs decline. Under the Alternative option, some of the decrease in cost is o ffset by additional Tier 1 public notification from the increase in the number of E. coli MCL violations detected. Burden hour estimate for State unit PN costs are derived from the Draft Information Collection Request for the Public Water System Supervision Program (USEPA 2008b). Exhibit VI-24 summarizes annualized State cost estim at es for public notification.

Exhibit VI-24 Annualized State Cost Estimates for P ublic Notification ($Millions, 2007$)Document initiating EO 12866 review

171 3% discount rate 7% discount rate TCR - Total 0.44 $ 0.42 $ AIP - Total 0.06 $ 0.06 $ AIP - Net Change (0.38) $ (0.36) $ AIP - Percent Change -86% -86% Alternative Option - Total 0.08 $ 0.08 $ Alternative Option - Net Change (0.36) $ (0.34) $ Alternative Option - Percent Change -82% -80%

Note: Detail may not add due to independent rounding. Source: Proposed RTCR cost model, descri bed in chapter 7 of the Proposed RTCR EA (USEPA 2009a).
4. Nonquantifiable costs EPA believes that all of the rule elements that are the major drivers of the net change in costs from the current TCR have been quantifie d to the greatest degree possible. However, several items are not specifically accounted for in the cost anal ysis, and their exclusion from consideration may result in an overestimate of net change in cost between the TCR option and the AIP option or A lternative option. Under the Alternative option, PW Ss are required to sample no less often than quarterly. Under that requirement, PWSs may elect to forg o annual site inspections (especially in cases where the State performs or subsidizes the additional monitoring for PWSs that were previously monitoring annually) since th e annual inspections are not requir ed. However, due to a lack of data on the potential for discontinuing annual site visits under the Alternative option, the proposed RTCR cost model does not calculate the potential cost re ductions for discontinuing site inspections under the Alternative op tion. This leads to a potentia l overestimate of costs for the Alternative option (i.e., a cost savings may be realized for some States). In some instances, the performance of an asse ssment (especially a Level 2 assessment) may overlap with a scheduled sanitary survey. To th e extent that the requirements for the State to perform a sanitary survey may be satisfied as pa rt of the assessment process, PWSs and StatesDocument initiating EO 12866 review

172 may realize a cost savings compared to performing a separate sanitary survey. This potential for indirect cost savings is not captured in the cost model, resulting in a potential overestimate of costs stemming from propos ed RTCR implementation. Under the TCR, AIP, and Alternative options, Tier 3 public notification for monitoring and reporting violations are assumed to be reporte d once per year as part of the Consumer Confidence Report (CCR). Because of the use of the CCR to communicate Tier 3 public notification on a yearly basis, no cost differe ntial between the current TCR and the AIP and Alternative options is estimated in the cost m odel. However, the advisory committee concluded that significant reductions in monitoring and re porting violations may be realized through the revised regulatory framework of the proposed RTCR, which includes new consequences for failing to comply with monitori ng provisions such as the requir ement to conduct an assessment or ineligibility for reduced m onitoring. These possible reducti ons have not been quantified. Resources used to process monitoring violati on notices for the CCR (as well as the time spent responding to customer inquiries about the notices) may be reduced if sign ificant reductions are realized. Exclusion of this pot ential cost savings may lead to an underestimate of the PN cost savings under both the AI P and Alternative option. In each of the three cases described previously, the omission in the costing model leads to an overestimate of potential costs, re sulting in an underestimate of the net cost changes from the
current TCR. Additionally, as an underlying assumption to the costing methodology, EPA assumed that all PWSs subject to the proposed RTCR requirements are already complying with the current TCR. There may be some PWSs that are not in full compliance with the current TCR, and if so, additional costs and benefits are incurred.Document initiating EO 12866 review

173 G. Potential Impact of the Proposed RTCR on Households The household cost analysis considers the potent ial increase in a household’s water bill if a CWS passed the entire cost increase resulting from the proposed rule on to their customers. This analysis is a tool to gauge potential impacts and should not be c onstrued as a precise estimate of potential changes to household water bills. Stat e costs and costs to TNCWSs and NTNCWSs are not included in this analysis since their cost s are not typically passe d through directly to households. Exhibit VI-25 presents the mean expected increases in annual household costs for all CW Ss, including those systems that do not have to take corrective action. Exhibit VI-25 also presents the sam e information for CWSs that mu st take corrective action. Household costs tend to decrease as system size increases, due mainly to the economies of scale for the corrective actions. The first category in Exhibit VI-25 presents net costs per household under the AIP and Alternative options for a ll rule com ponents spread across all CWSs. In this scenario, comparison to the current TCR shows a cost savings for so me households. For thos e households that are expected to see a cost increase, the average annual water bill is expected to increase by less than five cents on average. While the average increase in annual household water bills to implement the AIP option is less than a dollar, customers served by a small CWS that have to take extensive corrective actions as a result of the proposed rule incur slightly larger incr eases in their wa ter bills. The subsequent categories of the exhi bit present net costs per household for three different subsets of CWSs: (1) CWSs that perform assessments but no corrective actions, (2 ) CWSs that perform corrective actions, and (3) CWSs that do not perform assessments or corrective actions. Approximately 77 percent of households are serv ed by CWSs that perform assessments but doDocument initiating EO 12866 review

174 not perform corrective acti ons over the 25-year period of anal ysis. These households experience a slight cost savings on an annual basis. The ni ne percent of households belonging to CWSs that perform corrective actions over the 25-year period of analysis experien ce an increase in annual net household costs of less than $0.70 on average for CWSs serving greater than 4,100 people to approximately $4 on average for CWSs serving 4 ,100 or fewer people on an annual basis. EPA estimated that 14 percent of hous eholds are served by CWSs that do not perform assessments or corrective actions over the 25-year period of anal ysis. This group of households served by small systems (4,100 or fewer people) expe riences a slight cost change on an annual basis, comparable to those performing assessments but no corrective actions. Overall, the main driver of additional household costs under the proposed RTCR is corrective actions.
Exhibit VI-25 Summary of Net Annual Per-Household Costs for the Proposed RTCR (2007$) 3% Discount Rate 7% Discount Rate Population Served by PWS AIP Option Net Cost per Household Alternative Option Net Cost per Household AIP Option Net Cost per Household Alternative Option Net Cost per Household All Community Water Systems (CWSs) ≤ 4,100 $0.07 $0.09 $0.10 $0.12 >4,100 $0.05 $0.05 $0.04 $0.04 Total $0.05 $0.06 $0.05 $0.05 Community Water Systems (CWSs) performing Level 1/Level 2 Assessments (and no Corrective Actions) ≤ 4,100 $(0.22) $(0.19) $(0.16) $(0.13) >4,100 $(0.02) $(0.01) $(0.01) $(0.01) Total $(0.02) $(0.01) $(0.01) $(0.01) Community Water Systems (CWSs) performing Corrective Actions ≤ 4,100 $4.11 $4.14 $3.63 $3.68 >4,100 $0.65 $0.65 $0.54 $0.54 Total $0.78 $0.78 $0.66 $0.66 Community Water Systems (CWSs) not performing Level 1/Level 2 Assessments, or Corrective Actions ≤ 4,100 $0.00 $0.02 $0.04 $0.06 >4,100 $0.00 $0.00 $(0.01) $(0.01) Total $0.00 $0.01 $0.01 $0.02 Source: Proposed RTCR EA (USEPA 2009a)Document initiating EO 12866 review

175 H. Incremental Costs and Benefits The proposed RTCR regulatory options achieve in creasing levels of be nefits at increasing levels of costs. The regulatory options for this proposed rule, in order of increasing costs and benefits (Option 1 lowest, and option 3 highest) are as follows:

• Option 1: Current TCR option

• Option 2: AIP option

• Option 3: Alternative option More information about the options is provi ded in the Proposed RTCR EA (USEPA 2009a). Incremental costs and benefits are those that are incurred or realized to reduce potential illnesses and deaths from one alternative to the ne xt more stringent alternative. Estimates of incremental costs and benefits ar e useful when considering the economic efficiency of different regulatory alternatives considered by EPA. Genera lly, the goal of an incremental analysis is to identify the regulatory alternatives where net social benefits are maximized. However, the usefulness of this analysis is constrained when major benefits and/or costs are not quantified or not monetized as in the case with the pr oposed RTCR. Also, as pointed out by the Environmental Economics Advisory Committee of th e Science Advisory Board, efficiency is not the only appropriate criterion for so cial decision making (USEPA 2000a). For the proposed RTCR, presentation of incremental quantitative benefit and cost comparisons cannot be directly compared be cause many of the proposed rule’s important potential benefits are not quant ified, such as the decreased in cidence of illness from fecal contamination and/or waterborne pathogens in cluding associated outbreaks and death. To compare the additional net cost increases and asso ciated incremental benefits of the AIP and the Alternative options, benefits are presented in terms of corrective actions performed sinceDocument initiating EO 12866 review

176 performance of corrective actions is expected to have an impact that is most directly translatable into potential health benefits. Exhibit VI-26 shows the incremental cost of the AIP over the current TCR and the Alternative option over the AIP op tion for costs annualized using three percent and seven percent discount rates. The increm ental benefits of the Alternative option in terms of incremental corrective actions performed (114 at three percen t and 135 and seven percent discount rates) are fewer than for the AIP (202 at three percent and 189 at seven percent disc ount rates), despite the increased costs. The relationship between the incr emental costs and benefits is examined further with respect to cost effectiveness in section VI.M of this preamble.
Exhibit VI-26 Incremental Net Change in Annualized Present Value Costs ($Millions, 2007$) and Benefits (Number of Corrective Actions)

Costs Benefits (L2 Corrective Actions) Regulatory Option 3% 7% 3% 7% Current TCR $ 186.1 $ 178.4 No change No change AIP $ 199.8 $ 192.5 202 189 Incremental AIP 1 $ 13.7 $ 13.7 202 189 Alternative $ 213.3 $ 208.5 317 323 Incremental Alternative 2 $ 13.5 $ 16.0 114 135 1 Represents the incremental net change of the AIP opti on over the current TCR option. 2 Represents the incremental ne t change of the Alternative option over the AIP option. Add incremental net change for Alternative option to in cremental net change for AIP option to calculate the total net change of the Alternative option ove r the current TCR option. Note: The RTCR occurrence model yields the number of corrective actions that are expected to be implemented in addition to (net of) those alread y implemented under the current TCR. The model does not incorporate an estimate of the number of corrective actions implemented per year under the current TCR and does not yield a total for the AIP and Alternative option that includes the current TCR corrective actions. Benefits s hown include corrective actions based on L2 assessments. Detailed benefits and cost in formation is provided in Appendices A and C, respectively, of the Propos ed RTCR EA (USEPA 2009a).

I. Benefits from Simultaneous Reducti on of Co-occurring ContaminantsDocument initiating EO 12866 review

177 As discussed in section VI.E, the potential benefits from the proposed RTCR include avoidance of a full range of health effects fr om the consumption of fecally contaminated drinking water, including the following: acute and chronic illness, endemic and epidemic disease, waterborne disease outbreaks, and death. Also since fecal contamination may contain waterborne pathogens incl uding bacteria, viruses, and parasitic protozoa, in general, a reduction in fecal contamination should also reduce the ri sk from these other contaminants. Additional health benefits of the proposed RTCR include the reduction in illnesses and deaths associated with reduced incidence of upsets or failures fr om disinfecting operations and reduced incidence of distribution system contamination in both disinfecting and non-disinf ecting systems. EPA anticipates reductions in disease incidence associ ated with these situat ions to result from the assessment provisions and corrective provisions. Systems may choose corrective actions that also address other drinking water contaminants. For example, correcting for a path way of potential contamination in to the distribution system can mitigate a variety of potential contaminants. Due to a lack of contamination co-occurrence data that could relate to the effect that treatme nt corrective action may have on contamination entering through distribution system pathways, EPA has not quantif ied such potential benefits.
J. Change in Risk from Other Contaminants It is unlikely that the RTCR results in an in crease in risk from other contaminants. All surface water systems are alrea dy required to disinfect under the SWTR (USEPA 1989b, 54 FR 27486, June 29, 1989) but this rule could imp act currently non-disinfecting ground water systems. When disinfection is first introduced into a previously undisinfected GW system, the disinfectant can react with pipe scale causing increased risk from so me contaminants that may be entrained in the pipe scales a nd other water quality problems. Ex amples of contaminants thatDocument initiating EO 12866 review

178 could be released include lead, copper, and arseni c. Disinfection could also possibly lead to a temporary discoloration of the wa ter as the scale is loosened from the pipe. These risks can be addressed by gradually phasing in disinfection to the system, by ta rgeted flushing of distribution system mains, and by maintaining a proper corrosion control program. Introducing a disinfectant could also result in an increased risk from disinfection byproducts (DBPs). Risk from DBPs has already been a ddressed in the Stage 1 Disinfection Byproducts Rule (DBPR) (USEPA 1998c) and additional consid eration of DBP risk has been addressed in the final Stage 2 DBPR (USEPA 2006e). In ge neral, ground water system s are less likely to experience high levels of DBPs than surface wate r systems because they have lower levels of naturally occurring organic materi als (generally represented by to tal organic carbon (TOC)) that contribute to DBP formation. Fo r the most part, ground water syst ems with high levels of TOC in their ground water source are located in States that already require ground water systems to disinfect, therefore decreasing th e chance that significant disinfection byproduct problems result from this proposed rule. EPA does not expect many previously undisinfecte d systems to add disinfection as a result of either the AIP or Alternative rule options. See section 7.4.6 of the Proposed RTCR EA (USEPA 2009a) for a discussion on corrective action.
K. Effects of Fecal Contamination and/or Wate rborne Pathogens on the General Population and Sensitive Subpopulations As discussed previously in this preamble, fecal contamination may contain waterborne pathogens including bacteria, viruses, and pa rasitic protozoa. Fecal contamination and waterborne pathogens can cause a variety of illne sses, including acute gastrointestinal illness (AGI) with diarrhea, abdomina l discomfort, nausea, vomiting, a nd other symptoms. Most AGIDocument initiating EO 12866 review

179 cases are of short duration and result in mild illness. Other more severe illnesses caused by waterborne pathogens include he molytic uremic syndrome (HUS) (k idney failure), hepatitis, and bloody diarrhea (WHO 2004). Chronic disease su ch as irritable bowel syndrome, reduced kidney function, hypertension and reactive arthritis can result from infection by a waterborne agent (Clark et al . 2008). When humans are exposed to and infected by an enteri c pathogen, the pathogen becomes capable of reproducing in the gastrointestinal tract. As a result, healthy humans shed pathogens in their feces for a period ranging from days to w eeks. This shedding of pathogens often occurs in the absence of any signs of clinical illness. Regardless of whether a pathogen causes clinical illness in the person who sheds it in his or her fe ces, the pathogen being shed may infect other people directly by person-to-pers on spread, contact with contaminated surfaces, and other means which are referred to as secondary spread. As a result, waterborne pathogens that are initially waterborne may subsequently infect other people through a variety of routes (WHO 2004). The general population typically experiences acu te gastrointestinal illness (some illnesses may be severe such as kidney failure) when expos ed to fecal contamination and/or waterborne pathogens. When sensitive subpopulations expe rience the same exposure as the general population, more severe illness (and sometimes death) can occur. Examples of sensitive subpopulations are provid ed in chapter 2 of the Proposed RTCR EA (USEPA 2009a). This section discusses the pote ntial health effects associated with sensitive population groups, especially children, pregnant women, and the elderly. It is anticipated that the requirements of the proposed RTCR will help reduce pathways of entry for fecal contamination and/ or waterborne pathogens into the distribution system, thereby reducing risk to both the general population as well as to sensitive subpopulations.Document initiating EO 12866 review

180 1. Risk to children, pregna nt women, and the elderly While bacterial illnesses are not addressed in a quantified benefits analysis as discussed previously in this preamble, the nonquantified be nefits associated with the proposed RTCR could be significant for sensitive subpopulations. Childre n and the elderly are pa rticularly vulnerable to kidney failure (hemolytic uremic s yndrome) caused by the pathogenic bacterium E. coli O157:H7. Waterborne outbreaks due to E. coli O157:H7 have caused kidney failure in children and the elderly as the result of disease outbr eaks from consuming ground water in Cabool, Missouri (Swerdlow et al. 1992); Alpine, Wyoming (Olsen et al. 2002); Washington County, New York (NY State DOH 2000); and Walkerton, Ontario, Canada (Health Canada 2000). The risk of acute illness and death due to viral contaminati on of drinking water depends on several factors, including the age of the expos ed individual. Infants and young children have higher rates of infection and di sease from enteroviruses than other age groups (USEPA 1999). Several enteroviruses that can be transm itted through water can have serious health consequences in children. Enteroviruses (w hich include poliovirus, coxsackievirus, and echovirus) have been implicated in cases of flaccid paralysis, myo carditis, encephalitis, hemorrhagic conjunctivitis, and diabetes me llitus (Dalldorf and Melnick 1965; Smith 1970; Berlin et al. 1993; Cherry 1995; Melnic k 1996; CDC 1997; Modlin 199 7). Women may be at increased risk from enteric viruses during pregnancy (Gerba et al . 1996). Enterovirus infections in pregnant women can also be transmitted to the unborn child late in pregnancy, sometimes resulting in severe illness in the newborn (USEPA 2000d). Waterborne viruses can also be particularly harmful to children. Rotavirus disproportionately affects children less than five years of age (Parashar et al . 1998). However, the pentavalent rotavirus vaccine licensed for use in the United States has been shown to be 74Document initiating EO 12866 review

181 percent effective against rotaviru s gastroenteritis of any severity (Dennehy 2008). For echovirus, children are disproportionately at risk of b ecoming ill once infected (Modlin 1986). According to CDC, echovirus is not a vaccine-preventable disease (CDC 2009). The elderly are particularly at ri sk from diarrheal diseases (Glass et al . 2000) such as those associated with waterborne pathogens in the US . Approximately 53 percent of diarrheal deaths occur among those older than 74 years of age, and 77 percent of diarrheal deaths occur among those older than 64 years of age. In Cabool, Missouri (Swerdlow et al . 1992), a waterborne E. coli O157:H7 outbreak in a ground wa ter system resulted in four deaths, all among the elderly. One death occurred from hemolytic uremic syndrome (kidney failure), the others from gastrointestinal illness. Hospitalizations due to diarrheal disease are hi gher in the elderly th an younger adults (Glass
et al . 2000). Average hospita l stays for individuals older than 74 years of age due to diarrheal illness are 7.4 days compared to 4.1 days for individuals aged 20 to 49 (Glass et al . 2000). It is anticipated that the requirements of the proposed RTCR will help reduce pathways of entry for fecal contamination and/ or waterborne pathogens into the distribution system, thereby reducing risk to both the general population as well as to sensitive subpopulations such as children, pregnant women, and the elderly.
2. Risk to immunocompromised persons AGI symptoms may be more severe in immunocompromised persons (Frisby et al . 1997; Carey et al . 2004). Such persons include those with acquired immune deficiency syndrome (AIDS), cancer patients undergoing ch emotherapy, organ transplant re cipients treated with drugs that suppress the immune system, and patients wi th autoimmune disorders such as lupus. In AIDS patients, Cryptosporidium , a waterborne protozoa, has been found in the lungs, ear,Document initiating EO 12866 review

182 stomach, bile duct, and pancreas in additi on to the small intes tine (Farthing 2000). Immunocompromised patients with severe pers istent cryptosporidiosis may die (Carey et al

. 2004). For the immunocompromised, Gerba et al . (1996) reviewed the lite rature and reported that enteric adenovirus and rotavirus are the two wate rborne viruses most commonly isolated in the stools of AIDS patients. For patients undergoing bone-marrow transplants, several studies cited by Gerba et al . (1996) reported mortality ra tes greater than 50 percent among patients infected with enteric viruses. It is anticipated that the requirements of the proposed RTCR will help reduce pathways of entry for fecal contamination and/ or waterborne pathogens into the distribution system, thereby reducing risk to both the general population as well as to sensitive subpopulations such as the immunocompromised.
L. Uncertainties in the Benefit and Cost Estimates for the Proposed RTCR A computer simulation model was used to estimat e costs and indicators of benefits of the proposed RTCR. Exhibit VI-27 shows that these output s depend on a num ber of key model inputs. This section describes analyses that were conducted to understand how uncertainties in these inputs contributed to un certainty in model outputs.
Exhibit VI-27 Simulation Model, Inputs, and OutputsDocument initiating EO 12866 review

183 1. Inputs and their uncertainties It is anticipated that the requirements of th e proposed RTCR will help reduce pathways of entry for fecal contamination and/ or waterborne pathogens into the distribution system, thereby reducing exposure and illness from these contaminants in drinking water. These exposure and illness reductions could not be modeled and estimated quantitatively, due to a lack of a quan titative relationship between indicators and pathogens. Section VI.E.3 of this preamble and chapter 6 of the Proposed RTCR EA (USEPA 2009a) discuss this issue qualitatively.Document initiating EO 12866 review

184 Model outputs include two important indicators of microbial exposure: E. coli occurrence in routine total coliform samples and the occurrence of Level 1 and 2 assessments. These outputs were monitored as endpoints in the sensitivity analyses described in this section. Quantified national cost estimates include costs of required monitoring, assessments, corrective actions, and public no tifications. Total costs were monitored as end-points in the sensitivity analyses desc ribed in this section. None of the inputs shown in Exhibit VI-27 is perfectly know n, so each h as some degree of uncertainty. Some of these inputs are informed directly by data, so their uncertainties are due to limitations of the data. For example, uncertainty about the statistical mode l used to characterize occurrence is due to the limited numbers of sy stems and measurements per system in the SixYear Review 2 dataset. Other inputs are informed by professional judgment, so their uncertainties are expressed in terms of reasona ble upper and lower bounds th at are, themselves, based on expert judgment. For example, 10 per cent of assessments (representing the incremental increase over the current TCR) are expected to result in effective co rrective actions, based on professional judgment, with reasonable upper an d lower bounds of 20 pe rcent and 5 percent, respectively. Sensitivity analyses were conducted to assess the degree to which uncertainties about selected inputs contribute to uncertainty in th e resulting cost estimates. The analyses focused on the inputs that are listed in Exhibit VI-27. Results are detailed in the Proposed RTCR EA (USEPA 2009a). Not shown in Exhibit VI-27 are some inputs that ar e very well known. These are inventory data, which include the list of all PWSs a ffected by the propo sed RTCR and, for each system, information on its source water type, disinfecti on practice, and population served. Although thisDocument initiating EO 12866 review

185 information is not perfect, any uncertainty is believed to have negligible impact on model outputs. EPA did not conduct sensitivity analyses to evaluate the importance of these small uncertainties.
2. Sensitivity analysis Default values of the model inputs are consid ered reasonable best-estimates. Model outputs that are obtained when the inputs are set to these default values are also considered to be reasonable best-estimates. EPA conducted sensi tivity analyses to learn how much the outputs might change when individual inputs are changed fr om their default values. The approach taken was to change each input to some reasonable upper and lower bounds, based on professional judgment. Many of the uncertainties are expected to imp act the model output in a similar fashion for the current TCR, AIP, and the Alternative options. For example, an increase in a total coliform occurrence tends to increase the total cost and bene fit estimates for all of the rule alternatives. Because the benefit and cost analyses focus on net changes among the current TCR, AIP, and Alternative options, these comm on sources of uncertainty may tend to cancel out in the net change analyses. Other uncertainties were expe cted to have stronger influence on net changes among the current TCR, AIP, and Alternative opti ons because they influence some options, but not others. For example, assumptions about the effectiveness of corrective actions influences total costs of the proposed RTCR options, but not the current TCR option itself. Results of the sensi tivity analyses (reported in th e Proposed RTCR EA (USEPA 2009a)) showed that the fundamental conclusions of th e economic analysis do not change over a wide range of assumptions.
M. Benefit Cost Determination for the Proposed RTCRDocument initiating EO 12866 review

186 Pursuant to SDWA section 1412(b)(6)(A), EPA has determined that the benefits of the proposed RTCR justify the costs. In making this determination, EPA considered quantified and nonquantified benefits and costs as well as th e other components of the HRRCA outlined in section 1412(b)(3)(C) of the SDWA. Additionally, EPA used several ot her techniques to compare benefits and costs including a break-even analysis and a cost effectiveness anal ysis. The break-even anal ysis (see chapter 9 of the Proposed RTCR EA (USEPA 2009a)) was conducted using two example pathogens responsible for some (unknown) pr oportion of waterborne illnesses in the United States: shiga toxin-producing EC O157:H7 1 (STEC O157:H7) and Salmonella. Based on either example pathogen considered in the breakeven analysis, a small number of fatal cases annually would need to be avoided, relative to the CDC’s estim ate of cases caused by waterborne pathogens, in order to break even with rule costs. For ex ample, under the AIP option, just two deaths would need to be avoided annually using a 3 percen t discount rate based on consideration of the bacterial pathogen STEC O157:H7 . Alternatively, approximat ely 3,000 or 8,000 non-fatal cases, using the enhanced or traditiona l approach, respectively, would need to be avoided to break even with rule costs. As expected based on its co sts, the lower cost of the AIP option means that fewer cases need to be avoided in order to break even. See Exhibit VI-28. As Exhibit VI-28 shows, approximately 2 d eaths would need to be avoided from a Salmonella infection for the rule to break ev en. The estimated number of non-fatal Salmonella cases that would need to be avoided to br eak even is approximately 10,000 or 65,000 cases under the enhanced and traditional approaches, respect ively. Given the large number of potential

1 According to the website of the Amer ican Academy of Family Physicians ( http://www.aafp.org/afp/20000401/tips/11.html ), “Shiga toxin-producing Escherichia coli is a group of bacteria strains capable of causing significant human disease. The pathogen is transmitted primarily by food and has become an important pathogen in industrialized No rth America. The subgroup enterohemorrhagic E. coli includes the relatively important serotype O157:H7, and more than 100 other non-O157 strains.”Document initiating EO 12866 review

187 waterborne pathogens shown to occur in PWSs a nd the relatively low net costs of the proposed RTCR, EPA believes, as discussed in this se ction and in the Proposed RTCR EA (USEPA 2009a), that the AIP option is likely to break even. Chapter 9 of the Proposed RTCR EA (USEPA 2009a) has a complete discussion of the break-even an alysis and how costs per case were calculated

Exhibit VI-28 Estimated Breakeven Threshold for Avoided Cases of E. coli O157:H7 and Salmonella AIP Option Alternative Option Cost of Illness (COI) Methodology Discount Rate Non-fatal cases only Fatal cases only 1 Non-fatal cases only Fatal cases only 1 E. coli O157:H7 3% 8,000 1.6 16,000 3.1

Traditional COI 7% 8,000 1.5 17,000 3.4 3% 3,000 1.6 5,000 3.1 Enhanced COI 7% 3,000 1.5 6,000 3.4 Salmonella 3% 65,000 1.6 130,000 3.1

Traditional COI 7% 65,000 1.6 141,000 3.4 3% 10,000 1.6 20,000 3.1 Enhanced COI 7% 10,000 1.6 21,000 3.4 1 Calculations for fatal cases include the non-fa tal cost of illness (C OI) component for the underlying illness prior to death. Note: The number of cases needed to reach brea k-even threshold is calculated by dividing the net change in costs for the proposed RTCR by the average estimated value of avoided cases. E. coli O157:H7 and Salmonella are only two of multiple pathoge nic endpoints that could have been used for this analysis. Use of additional pathogenic contaminants in addition to these single endpoints would result in lower threshold values. Detail may not add due to independent rounding. Differences in the three percent and seven pe rcent estimates among the AIP and Alternative Analysis can be explained by how costs accrue over the period of analysis. Cost for the AIP are relatively consistent across the period of analysis while greater costs for the Alternative occur early in the rule implementation period due to increases in monitoring and corrective actions. Cost-effectiveness is another way of examining the benefits and costs of the proposed rule. Exhibit VI-29 shows the cost of the rule per corrective action avoided. The cost-effectivenessDocument initiating EO 12866 review

188 analysis, as with the net benef its, is limited because EPA was able to only partially quantify and monetize the benefits of the proposed RTCR. As discussed previously and demonstrated in the Proposed RTCR EA (USEPA 2009a), the proposed rule , i.e., the AIP option, achieves the lowest cost per corrective action avoided among the op tions considered. The incremental costeffectiveness analysis shows that the AIP ha s a lower cost per corrective action than the Alternative option.

Exhibit VI-29 Total Net Annual Cost Per Corrective Action (CA) Implemented under AIP and Alternative Options, Annualized (using three percent and seven percent discount rates) ($2007) Regulatory Scenario 3% Discount Rate 7% Discount Rate AIP Net Cost ($ Millions) $ 13.7 $ 13.7 AIP Net Corrective Actions (L1 & L2) 598 555 AIP Cost Effectiveness Analysis (C EA )(net rule cost/CA) $ 22,899 $ 24,610 Alternative Option Net Cost $ 27.2 $ 29.7 Alternative Option Net Correct ive Actions (L1 & L2) 785 765 Alternative Option CEA (net rule cost /CA) $ 34,718 $ 39,812 Note: Corrective actions include those conducted as a resu lt either Level 1 or Level 2 assessments. Total rule costs are shown in Exhibit 9.14 of the Proposed RTCR EA (USEPA 2009a). Detailed benefits and cost information is provided in A ppendices A and C, respectively, of the Proposed RTCR EA (USEPA 2009a).

EPA also considered the incremental cost-effect iveness of the AIP option as compared to the Alternative option to determine the additional bene fit associated with the portion of cost for the Alternative option that exceeds the cost of the AIP option. Exhibit VI-30 shows that in increm ental terms for all PWSs, the AIP option has a far lower unit cost per unit benefit than the Alternative option. EPA further considered the group of 60,200 TNCWSs serving 100 or fewer people and using GW, which are the largest subset of systems by size and type. This group is expected to bear the highest aggregate burden under the proposed RTCR because of the number of systems in the group, but the per cost system of this group is relatively low, ($83 annualized at 3% discount in 2007$). The two incremental analyses ( Exhibit VI-30 and Exhibit VI-31)Document initiating EO 12866 review

189 together indicate that, using a three percent disc ount rate to compare incremental benefits and costs, the AIP option is significantly more cost-e ffective than the Alternative option by a factor of about four for the most burdened subset of sy stems and by a factor of greater than three when considering all PWSs together. Additional info rmation about this analysis and other methods used to compare benefits and costs can be found in chapter 9 of the Proposed RTCR EA (USEPA 2009a).

Exhibit VI-30 Incremental Rule Cost Per Corrective Ac tion (CA) Implemented under AIP and Alternative Options, Annualized (u sing three percent and seven percent discount rates) ($2007) Regulatory Scenario 3% Discount Rate 7% Discount Rate A. AIP Incremental Net Costs ($ millions) 1 $ 13.7 $ 13.7 B. AIP Incremental Net Corrective Actions (L1 & L2) 1 598 555 C. AIP Incremental Cost per CA ($) (C = A/B) $ 22,899 $ 24,610 D. Alternative Option Incremental Net Costs ($ millions) 2 $ 13.5 $ 16.0 E. Alternative Option Incremental Net Corrective Actions (L1 & L2) 2 187 210 F. Alternative Option Incremental Cost per CA ($) (F = D/E) $ 72,582 $ 76,299 Notes: Detail may not add due to independent rounding. Exhibit includes only the number of corrective actions predicte d by the RTCR occurrence model to be implemented in addition to those implem ented under the current T CR. Includes corrective actions (CAs) in response to both Level 1 and Le vel 2 assessments. To tal net costs for each option and total CAs (not incremental) are s hown in Exhibit 9.15 of the Proposed RTCR EA (USEPA 2009a). Detailed benefits and cost information is provided in Appendices A and C, respectively, of the Propos ed RTCR EA (USEPA 2009a). 1 Represents the incremental increase of the AIP option over the current TCR. 2 Represents the incremental increase of the Alternative option over AIP option. Add incremental net values for Alternative option to incremental net values for AIP option to calculate total net values of Alternative option over current TCR.

Exhibit VI-31 Incremental Rule Cost Per Corrective Ac tion (CA) for TNCWSs using GW Implemented under AIP and Alternative Opti ons, Annualized (using three percent and seven percent discount rates) ($2007)Document initiating EO 12866 review

190 Regulatory Scenario 3% Discount Rate 7% Discount R 1. AIP Incremental Net Costs ($ millions) 1 $ 5.1 $ 2. AIP Incremental Corrective Acti ons (L1 & L2) (TNCWS <101 only) 1 279 3. AIP Incremental Cost per CA ($) $ 18,219 $ 19 , 4. Alternative Option Incremental Net Costs ($ millions) 2 $ 8.3 $ 5. Alternative Option Incremental Corrective Actions (L1 & L2) (TNCWS <101 only) 2 128 6. Alternative Option Incr emental Cost per CA ($) $ 64,731 $ 67 , 1 Represents the incremental increase of the AIP option over the current TCR. 2 Represents the incremental increase of the Alternative option over AIP option. Add incremental net values for Alternative option to incremental net values for AIP opti on to calculate total net values of Alternative option ov e current TCR. Note: Detail may not add due to independent rounding. Incremental Net Costs are based on TNCWSs serving <101 pe ople. Detailed benefits and cost information is provided in Appendices A and C, respectivel y, of the Proposed RTCR EA (USEPA 2009a). The preferred option for the proposed RTCR is the AIP option. The analyses performed as part of the Proposed RTCR EA (USEPA 2009a) s upport the collec tive judgment and consensus of the advisory committee that the AIP requirement s provide for effective and efficient revisions to the current TCR regulatory requirements. The estimated net cost of the AIP option is small ($14M annually) as compared to the current T CR and small compared to the net cost of the Alternative option ($27M – $30M) as compared with the current TCR. In addition, the net benefits are expected to be pos itive under the AIP option and no b acksliding in overall risk is predicted. While the number of corrective actions unde r the Alternative opti on is greater than under the AIP option, the achievement of these benef its is not as cost effective as under the AIP option. EPA's Proposed RTCR EA (USEPA 2009a) shows that additional monitoring is likely to lead to more corrective actions under the Alternative option than under either the current TCR option or the AIP option but with significant increase in costs, especially for small systems. EPA concluded that the increased costs associated with the Alternative option did not justify the increased benefits because under the AIP option, States could trade off monitoring for systemDocument initiating EO 12866 review

191 site visits due to limited State resources. In pa rticular, the cost-effectiveness analysis shows that the Alternative option is not as cost-effective as the proposed AIP option.
N. Request for Comment EPA requests comment on its assessment of the benefit-cost determination conclusion.
VII. Statutory and Executive Order Review
A. Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866 (58 FR 51735, Octobe r 4, 1993), this actio n is a “significant regulatory action” because it raises novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set fo rth in the Executive Orde r. Accordingly, EPA submitted this action to the Office of Mana gement and Budget (OMB) for review under Executive Order 12866 and any changes made in re sponse to OMB recommendations have been documented in the docket for this action. EPA estimates that the proposed RTCR will have an overall impact on public water systems of $14 M and that the impact on small entities (PWSs serving 10,000 people or fewer) will be $9.4 M - $9.8 M annualized at 3 and 7 percent disc ount rates, respectively. These impacts are described in sections VI and V II.C of this preamble, respectively, and in the analysis that EPA prepared of the potential costs and benefits of this action, contained in the Proposed RTCR EA (USEPA 2009a)
B. Paperwork Reduction Act The information collection requirements for the proposed RTCR have been submitted for approval to the OMB under the Paperwork Reduc tion Act, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document prepared by EPA has been assigned EPA ICR number 1895.06.Document initiating EO 12866 review

192 The Paperwork Reduction Act requires EPA to estimate the burden on public water systems (PWSs) and State/primacy Agencies of complying with the rule. The information collected as a result of EPA’s efforts toward proposing the proposed RTCR should allow States/primacy agencies and EPA to determine appropriate requirements for specific systems and evaluate compliance with the proposed RTCR. Burden is defined at 5 CFR 1320.3( b) and means the total time, effort, and financial resour ces required to generate, maintai n, retain, disclose, or provide information to or for a Federal agency. The burden includes the time needed to conduct the following State and public water system (PWS) activities: State activities:

• Read and understand the rule;

• Mobilize (including primacy app lication), plan, and implement;

• Train PWS and consultant staff;

• Track compliance;

• Analyze and review PWS data;

• Review sampling plans and recommend any revisions to PWSs;

• Make determinations concerning PWS monitoring requirements;

• Respond to PWSs with positive samples;

• Recordkeeping;

• Review completed assessment forms and consul t with the PWS about the assessment report;

• Review and coordinate with PWSs to de termine optimal corrective actions to be implemented; and

• Provide consultation, review public notification certifications, and file reports of violations.Document initiating EO 12866 review

193 PWS activities:

• Read and understand the rule;

• Planning and mobilization activities;

• Revise existing sampling plans to identify samp ling locations and collection schedules that are representative of water th roughout the distribution system;

• Conduct routine, additional rou tine, and repeat monitoring;

• Complete a Level 1 Assessment if the PWS e xperiences a Level 1 trigger, and submit a timetable to the State to identify sanitary de fects detected, corrective actions completed, and a timetable for any corrective actions not already completed;

• Complete a Level 2 Assessment if the PWS e xperiences a Level 2 trigger, and submit a timetable for any corrective actions not already completed;

• Correct sanitary defects found through the perfor mance of Level 1 or Level 2 assessments;

• Develop and distribute Tier 1 public notices when E. coli MCL violations occur;

• Develop and distribute Tier 2 pub lic notices when the PWSs faile d to take corrective action; and

• Develop and distribute Tier 3 public notices when the PWSs failed to comply with the monitoring requirements or with mandatory re porting of required info rmation within the specified timeframe. For the first three year s after publication of the final rule in the Federal Register , the major information requirements apply to 154,894 respondent s. The total incremental burden associated with the change in moving from the information requirements of the current TCR to those in the proposed RTCR over the three years covered by the ICR is 2,518,878 hours, for an average of 839,526 hours per year. The total incremental cost over the three year clearance period isDocument initiating EO 12866 review

194 $71.3 million, for an average of $23.8 million per year (simple average over three years). The average burden per response (i.e., the amount of time needed for each activity that requires a collection of information) is 5.4 hours; the aver age cost per response is $153.4. The collection requirements are mandatory under SDWA (42 U.S.C. 300h et seq. ). Detail on the calculation of the proposed rule information collection burden and costs can be found in the Information Collection Request for the Proposed Re vised Total Coliform Rule (USEPA 2009d) and chapter 7 of the EA (USEPA 2009a). A summary of the burdens and costs of th e proposed collection is presented in Exhibit VII-1. Exhibit VII-1 Average Annual Net Change Bu rden and Costs for the Proposed RTCR ICR
Cost Respondent Type Annual Burden Hours Annual Labor Cost Annual Operation & Maintenance (O&M) Cost Annual Capital

Cost Total Annual

Cost Annual Responses

PWSs 747,848 $20,171,639 $0 $0 $20,171,639 103,225 States and Territories 91,678 $3,595,421 $0 $0 $3,595,421 51,669 Total 839,526 $23,767,060 $0 $0 $23,767,060 154,894 Notes: Detail may not add exactly to total due to independent rounding. “Annual Burden Hours” reflects an annual averag e for all system sizes over the 3-year ICR period. Source: Information Collection Request for th e Proposed Revised Total Coliform Rule (USEPA 2009d) An agency may not conduct or sponsor, a nd 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. To comment on EPA’s need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burd en, EPA has established a public docket for this proposed rule, which includes this ICR, under Docket ID number EPA-HQ-OW-2008-0878. Submit any comments related to the ICR to EPA and OMB. See ADDRESSES section at theDocument initiating EO 12866 review

195 beginning of this notice for where to submit comm ents to EPA. Send comments to OMB at the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after [INSERT DATE OF PUBLICATION IN THE FEDERAL REGISTER] , a comment to OMB is best assured of having its full effect if OMB receives it by [INSERT DATE 30 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER] . The final rule will respond to any OMB or public comments on the information collectio n requirements contained in this proposal.
C. Regulatory Flexibility Act (RFA) 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 substa ntial number of small entities. Small entities include small businesses, small organizati ons, 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 Admi nistration’s (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdic tion 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 enterp rise which is independe ntly owned and operated and is not dominant in its field." However, the RFA also authorizes an ag ency to use alternative definitions for each category of small entity, “w hich are appropriate to the activities of the agency” after proposing the alte rnative definition(s) in the Federal Register and taking comment.Document initiating EO 12866 review

196 5 USC 601(3) - (5). In addition, to establish an alternative small business definition, agencies must consult with SBA’s Chief Counsel for Advocacy. For purposes of assessing the impacts of the proposed RTCR on small entities, EPA considered small entities to be PWSs serving fewe r than 10,000 people. This is the cut-off level specified by Congress in the 1996 Amendments to the Safe Drinking Water Act for small system flexibility provisions. As required by the RFA, EPA proposed using this alternative definition in the Federal Register (63 FR 7620, February 13, 1998), reque sted public comment, consulted with the SBA, and finalized the alternative definition in the Consumer Confidence Reports regulation (63 FR 44524, August 19, 1998). As stat ed in that Final Ru le, the alternative definition would be applied for all future drinking water regulations. After considering the economic im pacts of today’s proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. The small entities directly regulated by this proposed rule are small PWSs serving fewer than 10,000 people. These include small CWSs, NTNCWSs, and TNCWSs, entities such as municipal water systems (publicly and privatel y owned), and privately-owned PWSs and for profit businesses where provision of water may be ancillary, such as mobile home parks, day care centers, churches, schools and homeowner asso ciations. We have determined that only 61 of 150,672 small systems (0.04%) will experience an impact of more than 1% of revenues, and that none of the small systems will experience an impact of 3% or greater of revenue. This information is described further in chapte r 8 of the Proposed RTCR EA (USEPA 2009a). Although this proposed rule will not have a significant economic im pact on a substantial number of small entities, EPA nonetheless has trie d to reduce the impact of this rule on smallDocument initiating EO 12866 review

197 PWSs. Provisions in the proposed RTCR that result in reduced costs for many small entities include:

• Reduced routine monitoring for qualifying PWS serving 1,000 or fewer people.

• Reduced number of repeat samples required.

• Reduced additional routine monitoring for PWS serving 4,100 or fewer people.

• Reduced public notification requirements fo r all systems, including small systems.

• Reductions in corrective actions over time as a re sult of enhanced system performance for all small systems. EPA also conducted outreach to small entiti es and convened a Small Business Advocacy Review Panel to obtain advice and recommendations of representatives of the small entities that potentially would be subject to the proposed rule's requirements. EPA consulted with small entity representatives before and during the review by the Panel. These small entity representatives included represen tatives from small water systems of various types and sizes, representatives from associations that assist and /or advocate for small systems, and Federal agencies that operate small systems. Panel members included representatives from OMB, the Small Business Administration, and the EPA Offi ce of Ground Water and Drinking Water. The consultation led to the development of a repor t providing recommendati ons to EPA on how to revise the TCR to address small system con cerns, which EPA considered in drafting this proposed RTCR (SBAR Panel 2008). EPA also made presentations to the advisory committee on the recommendations of the Panel so the advisory committee could consider their recommendations in developing the AIP. Consistent with the RFA/Small Business Re gulatory Enforcement Fairness Act (SBREFA) requirements, the Panel evaluated the assembled materials and small-entity comments on issuesDocument initiating EO 12866 review

198 and prepared a final report to th e EPA Administrator. A copy of the Panel report is included in the docket for this proposed rule. The propos ed rule is consistent with the Panel recommendations to use total coliforms as a trig ger for investigation and/ or corrective action, to balance monitoring requirements and costs with ri sk, to further differentiate requirements based on differences in water systems, to coordinate requirements with other related rules, and to consider reporting and recordk eeping costs in estimating burden. Consistent with the Panel recommendation to evaluate which parameters ar e most appropriate for routine monitoring and as potential triggers for inves tigative and correctiv e actions, EPA is c onducting a review of existing methods for total coliform and E. coli analysis and is evalua ting its Alternative Test Procedure protocol for approving ne w methods as described in sect ion III.9 of this preamble. EPA is also one of the founding members of a Re search and Information Collection Partnership, described in section V of this preamble, which is considering research and information needs to evaluate the magnitude of risks and potentia l risk mitigation options related to potential distribution system contamination. We continue to be interested in the potential impacts of th e proposed rule on small entities and welcome comments on issues related to such impacts.
D. Unfunded Mandates Reform Act (UMRA) This proposed rule does not contain a Federa l mandate that may result in expenditures to State, local, and Tribal governments, in the aggr egate, or to the private sector, of $100 million or more in any one year. Expenditures associated w ith compliance, defined as the incremental costs beyond the current TCR, will not surpass $100 million in the aggregate in any year. Thus, this proposed rule is not subject to the requi rements of sections 202 and 205 of UMRA.Document initiating EO 12866 review

199 This proposed rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory require ments that might significantly or uniquely affect small governments. Costs to small entities are not signif icant, as described previously in section VII.C and are detailed in the Proposed RTCR EA ( 2009a). The regulatory requirements of the proposed RTCR are not unique to small governments, as they apply to all PWSs regardless of size.
E. Executive Order 13132: Federalism This action does not have Federalis m 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. The net change in cost for State, local, and Tribal governments in the aggregate is estimated to be approximately $0.1 M and $0.4M at three percent and seven percent discount rates, respectively. T hus, Executive Order 13132 does not appl y to this proposed rule. Although section 6 of Executive Order 13132 does not apply to the proposed RTCR, EPA conducted a Federalism Consultation, consistent with Executive Order 13132, in July 2008. The consultation included a stakehol der meeting where EPA requested comments on the impacts of the potential revisions to the TCR with respect to State, county and local governments. EPA did not receive any comments in response to this consultation. In addition, the advisory committee included representatives of Stat e, local and Tribal governments, and through this process EPA consulted with State, local, and Tribal government representatives to ensure that their views were considered when the AIP recommenda tions for the RTCR were developed.Document initiating EO 12866 review

200 In the spirit of Executive Or der 13132, and consistent with EPA policy to promote communications between EPA and State and lo cal governments, EPA specifically solicits comment on this proposed action fr om State and local officials.
F. Executive Order 13175: Consultation and Coordi nation with Indian Tribal Governments This action does not have tribal implications , as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). Thus, Executive Order 13175 does not apply to this action Although Executive Order 13175 does not apply to this action, EPA consulted with Tribal officials in developing this action. EPA has c onsulted with Tribal governments through the EPA American Indian Environmental Office, included a representative of the Native American Water Association on the advisory committee which developed recommendations regarding the proposed rule and signed the AIP, and has addr essed Tribal concerns throughout the regulatory development process, as appropriate. The consul tation included participation in three Tribal conference calls (EPA regional Tribal call (February 2008), National Indian Workgroup call (March 2008), and National Trib al Water Conference (March 2008 )). EPA requested comments on the current TCR, requested suggestions for current TCR revisions (March 2008), and presented possible revisions to the current TCR to the National Tribal Council (April 2008). In addition, the advisory committee included entities representing Tribal governments, and through this process EPA ensured that their views were considered when the AIP recommendations for the RTCR were developed. None of these consultati ons identified issues that were particular to Tribal entities. As a result of the Tribal consultations and other Tribal outreach, EPA has determined that the proposed RTCR is not antic ipated to have a negative impact on Tribal systems. Thus, Executive Order 131 75 does not apply to this action. EPA specifically solicits additi onal comment on this proposed action from Tribal officials.Document initiating EO 12866 review

201 G. Executive Order 13045: Protection of Children Fr om Environmental Health Risks and Safety
Risks The proposed RTCR is not subject to Execu tive Order 13045 (62 FR 19885, April 23, 1997) because it is not economically si gnificant as defined in Executive Order 12866, and because the Agency does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to child ren. This action’s health and ri sk assessments are contained in section VI of this preamble and in the Proposed RTCR EA (USEPA 2009a). EPA expects that the proposed RTCR would provide additional protection to both children and adults who consume drinking water supplied from PWSs. EP A also believes that the benefits of the proposed rule, including reduced health risk, accrue more to children because young children are more susceptible than adults to some waterborne illnesses. For example, the risk of mortality resulting from diarrhea is often greatest in the very young and elderly (Rose 1997; Gerba et al

. 1996), and viral and bacterial illn esses often disproportionately a ffect children. Any overall benefits of the rule would reduce this mortality risk for children. The public is invited to submit comments or id entify peer-reviewed st udies and data that assess effects of early life exposure to drinking water that contai ns fecal contaminants.
H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or
Use The proposed RTCR is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Add itionally, none of the proposed RTCR requirements involve the installation of treat ment or other components that use a measurable amount of
energy.Document initiating EO 12866 review

202 I. National Technology Transfer and Advancement Act Section 12(d) of the Nationa l Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 not e) 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 st andards are technical st andards (e.g., materials specifications, test methods, sampling procedures , and business practices) that are developed or adopted by voluntary consensus st andards bodies. NTTAA direct s EPA to provide Congress, through OMB, explanations when EPA decides not to use available and applicable voluntary consensus standards. The proposed RTCR involves technical voluntary consensus standards. EPA proposes to use several analytical methods to m onitor for total coliforms and/or E. coli as they are described in Standard Methods for the Exami nation of Water and Wastewater , 20 th and 21 st editions (Clesceri
et al. 1998; Eaton et al. 2005). Methods included in Standard Methods are voluntary consensus standards. The proposed rule incl udes 11 methods that can be used to test for total coliforms. Four of the 11 are described in Standard Methods

. EPA welcomes comments on this aspect of th e proposed rulemaking and, specifically, invites the public to identify potentially -applicable voluntary consensus standards and to explain why such standards should be us ed in this regulation.
J. Executive Order 12898: Federal Actions to A ddress Environmental Justice in Minority Populations and Low-Income Populations Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Its ma in provision directs federal agen cies, to the greatest extent practicable and permitted by law, to make environm ental justice part of their mission. AgenciesDocument initiating EO 12866 review

203 must do this by identifying and addressing as appropriate any dispr oportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this proposed rule wi ll not have disproportionately high and adverse human health or environmental effects on mi nority or low-income populations because it increases the level of environm ental protection for all affected populations without having any disproportionately high and adve rse human health or environm ental effects on any population, including any minority or low-income population
. The proposed RTCR applies uniformly to all PWSs. Consequently, the proposed RTCR provides health protection equally to all income and minority groups served by PWSs. The proposed RTCR and other drinking water regulations are expected to have a positive effect on human health regardless of th e social or economic status of a specific population. To the extent that contaminants in drinking water might be disproportionately high among minority or low-income populations (which is unknown), the proposed RTCR contributes toward removing those differences by assuring th at all public water systems meet drinking water standards and ta ke appropriate corrective action whenever appropriate. Thus, the proposed RTCR meets the intent of the Fe deral policy requiring incorporation of environmental just ice into Federal agency missions.
K. Consultations with the Science Advisory B oard, National Drinking Water Advisory Council, and the Secretary of Health and Human Services In accordance with section 1412 (d ) and (e) of the SDWA, EPA consulted with the Science Advisory Board (SAB), the National Drinki ng Water Advisory Counc il (NDWAC), and the Secretary of the US Department of Health and Human Services on the proposed RTCR.Document initiating EO 12866 review

204 EPA met with the Drinking Water Committee of the SAB to discuss the proposed RTCR on May 20, 2009 (teleconference) and June 9 and 10, 2009 (Washington, DC). The SAB Drinking Water Committee (DWC) review focused on (1) the data sources used to estimate baseline total coliform and E. coli occurrence, public water system profile , and sensitive subpopulations in the United States; (2) the occurrence analysis used to inform the benefits analysis; (3) the qualitative analysis used to assess the reduction in risk du e to implementation of the rule requirements; and (4) analysis of the engineering costs and costs to States result ing from implementation of the revisions. Overall, the SAB DWC supported EPA’s anal ysis. SAB members commended EPA for making use of the best available data to assess the impacts of the propos ed rule. The SAB DWC supported the decision by EPA not to quantify p ublic health benefits , acknowledging that EPA had insufficient data to do so. The SAB DW C recommended that EPA clarify rationales for assumptions; expand explanations of sensitivity analyses that were included; provide further justification in those ar eas in which sensitivity analyses we re not conducted; and collect data after promulgation of the rule to allow EPA to better understand the public health impacts of the RTCR. In response to the SAB DWC recomm endations, EPA conducted additional analyses, added exhibits, and expanded a nd clarified the text of the Proposed RTCR EA (USEPA 2009a) to make the analysis more transparent, robust, and easier to read. A copy of the SAB report (SAB 2009) is available in the docket for the proposed RTCR. EPA consulted with NDWAC on May 28, 2009, in Seattle, Washington, to discuss the proposed RTCR. NDWAC members expressed c oncern that a rule based on the AIP sounds complicated. Education was a common theme in the responses from NDWAC members. Some members recommended that EPA provide the utilit ies and States with tools to help themDocument initiating EO 12866 review

205 understand the revised rule provisions and to as sist with providing publ ic education. A few members stated that they would like to provide EPA with additional advice on public notification. In response to NDWAC’s concern, EPA is reque sting comment on whether the proposed RTCR would result in requirements that would be easier to impl ement compared to the
current TCR. NDWAC members also suggested that EPA request comment on the costs and benefits of reduced monitoring. Specifically, NDWAC expressed concern that a reducti on in the number of certain samples taken (such as the reduction in the number of repeat and additional routine samples for some small systems) could lessen th e opportunity for systems to identify violations. Thus, EPA is requesting comment on the cost and benefit of reduced monitoring. A few NDWAC members stated th at they would like to provi de EPA with additional advice on public notification. To follow up on this re quest, EPA met with several NDWAC members on July 1, 2009, to review and discuss the curre nt TCR public notification requirements, the advisory committee's recommendations on revisions to the public notifica tion requirements, and to obtain feedback from NDWAC members. At this meeting, NDWAC members discussed potential changes to health effects language. They noted that while some portions of the health effects language would still be appropriate under the proposed RTCR, some changes or additions may be appropriate. Potential inclusions include the use of two different types of Tier 2 public notice to account for the difference between failu re to conduct assessments and failure to complete corrective actions, as well as language concerning customer actions in response to violations (such as boiling water before use), and a change in th e description of health effects of coliform exposure by sensitive subpopulations. Th ey also recommended that EPA look at theDocument initiating EO 12866 review

206 public notification requirements fo r the GWR as they may also be appropriate for the proposed
RTCR. EPA completed its consultation with the US De partment of Health and Human Services on October 5, 2009, as required by SDWA section 1412(d). EPA also provided an informational briefing to the Food and Safety Group of the Food and Drug Administration.
L. Impacts on Sensitive Subpopulations as Requi red by Section 1412(b )(3)(C)(i) of the 1996 Amendments of the Safe Drinking Water Act (SDWA)

EPA is required to seek public comment regard ing the effects of contamination associated with the proposed RTCR on the general popula tion and sensitive subpopulations. Sensitive subpopulations include “infants, children, pregnant women, the elderly, individuals with a history of serious illness, or other subpopulations th at are identified as likely to be at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population” (SDWA section 1412(b)(3)(C)(i)(V ), 42 U.S.C 300g-1(b)(3)(C)(i)(V)). Pregnant and lactating women may be at an increased risk from pathogens as well as act as a source of infection for newborns. Infection during pregnancy may also result in the transmission of infection from the mother to the child in utero , during birth, or shortly thereafter. Since very young children do not have fully developed immune sy stems, they are at increased risk and are particularly difficult to treat. Infectious diseases are also a major probl em for the elderly because immune function declines with age. As a result, outbreaks of waterborne diseases can be devastating on the elderly community (e.g., nursing homes) and may in crease the possibility of significantly higher mortality rates in the elderly than in the general population.Document initiating EO 12866 review

207 Immunocompromised individuals are a grow ing proportion of the population with the continued increase in HIV/AIDS, the aging popul ation, and the escalation in organ and tissue transplantations. Immunocompromised individuals are more susceptible to severe and invasive infection. These infections are particularly difficult to treat a nd can result in a significantly higher mortality than in immunocompetent persons. It is anticipated that the requirements of the proposed RTCR will help reduce pathways of entry for fecal contamination and/ or waterborne pathogens into the distribution system, thereby reducing exposure and risk from these contaminan ts in drinking water to the entire general population. The proposed RTCR seeks to provide a similar level of drinking water protection to all groups including sensitive subpopulations, thus meeting the intent of this Federal policy.
M. Plain Language Executive Order 12866 requires each agency to writ e its rules in plain language. Readable regulations help the public find requirements qui ckly and understand them easily. Readable regulations may also increase compliance, stre ngthen enforcement, and decrease mistakes, frustration, phone calls, appeals, an d distrust of government. EPA ha s made every effort to write this preamble to the proposed rule in as clea r, concise, and unambiguous manner as possible. EPA requests comments on how to improve rule language to enhance readability and make it easier to understand.

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Swerdlow, D.L., B.A. Woodruff, R.C. Brady, P.M. Griffin, S. Tippen, H. Donnel Jr., E. Geldreich, B.J. Payne, A. Meyer Jr., J.G. Wells, K.D. Greene, M. Bright, N.H. Bean, and P.A. Blake. 1992. A waterborne outbrea k in Missouri of Escherichia co li O157:H7 associated with bloody diarrhea and death. Annals of Internal Medicine. 117(10):812 B 819.

USEPA. (United States Environm ental Protection Agency). 1989a. Drinking Water; National Primary Drinking Water Regulations: Total Coli forms (Including Fecal Coliforms and E. coli);
Final Rule . 54 FR 27544. (June 29, 1989).

USEPA. 1989b. National Primary Drinking Water Re gulations: Filtration, Disinfection, Turbidity, Giardia lamblia, Viruses, Legi onella, and Heterotrophic Bacteria; Final Rule . 54 FR 27486. (June 29, 1989).Document initiating EO 12866 review

218 USEPA. 1998a. National Primary Drinking Water Regul ations: Stage 1 Disinfectants and Disinfection Byproducts; Final Rule . 63 FR 69389. (December 16, 1998).

USEPA. 1998b. National Primary Drinking Water Regulations: Interim Enhanced Surface Water Treatment Rule; Final Rule . 63 FR 69477. (December 16, 1998).

USEPA. 1998c. Revisions to State Primacy Requirements to Implement Safe Drinking Water Act Amendments; Final Rule . 63 FR 23361. (April 28, 1998).

USEPA. 1999. Drinking Water Criteria Document for Enteroviruses and Hepatitis A: An
Addendum . January 15, 1999. EPA-822-R-98-043.

USEPA. 2000a. An SAB Report on EPA's White Paper Valuing the Benefits of Fatal Cancer Risk Reduction

. Prepared for the Environmental Economics Advisory Committee. July 27, 2000.
EPA-SAB-EEAC-00-013.

USEPA. 2000b. Stage 2 Microbial and Disinfection By products Federal Advisory Committee Agreement in Principle . 65 FR 83015. (December 29, 2000).

USEPA. 2000c. Guidelines for Preparing Economic Analyses. US EPA Office of the Administrator. EPA/ 240-R-00-003. September 2000.Document initiating EO 12866 review

219 USEPA. 2000d. Health Risks of Enteric Viral Infections in Children . Office of Science and Technology, Washington, D.C. EPA-822-R-00-010.

USEPA. 2002. National Primary Drinking Water Regul ations: Long Term 1 Enhanced Surface Water Treatment Rule; Final Rule . 67 FR 1812. (January 14, 2002).

USEPA. 2003. National Primary Drinking Water Regulat ions: Announcement of Completion of EPA’s Review of Existing Drinking Water Standards . 68 FR 42908. (July 18, 2003).

USEPA. 2004. EPA Microbiological Alternate Test Pr ocedure (ATP) Protocol for Drinking Water, Ambient Water, and Wastew ater Monitoring Methods, Guidance . EPA 821-B-03-004.

USEPA. 2005. Manual for the Certification of Labor atories Analyzing Drinking Water 5 th Edition, Office of Water, January 2005, EPA 815-R-05-004

USEPA. 2006a. Economic Analysis for the Final Ground Water Rule . EPA-815-R-06.014.

USEPA. 2006b. Information Collection Request for Contaminant Occurrence Data in Support of EPA's Second Six-Year Review of Nati onal Primary Drinking Water Regulations . EPA ICR Number 2231.01., OMB Control No. 2040.

USEPA. 2006c. National Primary Drinking Water Regulati ons: Ground Water Rule; Final
Rule . 71 FR 65574. (November 8, 2006).Document initiating EO 12866 review

220 USEPA. 2006d. National Primary Drinking Water Regulations: Long Term 2 Enhanced Surface Water Treatment Rule; Final Rule . 71 FR 654. (January 5, 2006).

USEPA. 2006e. National Primary Drinking Water Regul ations: Stage 2 Disinfectants and Disinfection Byproducts Rule; Final Rule . 71 FR 388. (January 4, 2006).

USEPA. 2007a. Establishment of the Total Coliform Rule Distribution System Advisory
Committee . 72 FR 35869. (June 29, 2007).

USEPA. 2007b. The Safe Drinking Water Information Sy stem – Federal Version (SDWIS/FED)
data . Available online: http://epa.gov/envi ro/html/sdwis/ (Apr 2009).

USEPA. 2008a. Draft Information Collection Re quest for the Microbial Rules . OMB Control Number: 2040-0205. EPA Tr acking Number: 1895.06.

USEPA. 2008b. Draft Information Collection Request fo r the Public Water System Supervision Program . OMB Control Number: 2040- 0090. EPA Tracking Number: 0270.43.

USEPA. 2008c. US Environmental Protection Agency Tota l Coliform Rule/Distribution Systems (TCRDS) Federal Advisory Committee Agreement In Principle . Available online: http://www.epa.gov//safewater/dis infection/tcr/pdfs/tcrdsac/ag reem entinprinciple_tcrdsac_2008- 09-18.pdf (June 2009).Document initiating EO 12866 review

221 USEPA 2009a. Economic Analysis for the Propo sed Revised Total Coliform Rule. EPA-815-XXX-XXX.

USEPA. 2009b. Technology and Cost Document for the Proposed Revised Total Coliform Rule

. EPA-815-X-XX-XXX.

USEPA. 2009c. Total Coliform Rule Compliance Monitoring Data Quality and Completion Report . EPA-815-X-XX-XXX.

USEPA. 2009d. Information Collection Request fo r National Primary Drinking Water Regulations: Proposed Revised Total Coliform Rule . EPA-815-X-XX-XXX.

USEPA. 2009e . National Primary Drinking Water Regulations: Airline Drinking Water Rule;
Final Rule . 74 FR 53590. (October 19, 2009).

USEPA and WRF. 2009. Memorandum of U nderstanding on the Total Coliform Rule / Distribution System Research and Informa tion Collection Partnership Between the US Environmental Protection Agency and the Wa ter Research Foundation (WRF). January 27, 2009.

van der Kooij, D. 2003. Managing regrowth in drinking water distribution systems. In: Heterotrophic Plate Counts.and Drinking-water Safety, The Significance of HPCs for WaterDocument initiating EO 12866 review

222 Quality and Human Health. Edited by Cotruvo, J.V., M. Exner, C. Fricker, and A. Glasmacher. IWA Publishing, London. pp.199-232.

Warren, L. S., R. E. Benoit, and J. A. Jessee. 1978. Rapid Enumeration of Fecal Coliforms in Water by a Colorimetric â-Galactosidase A ssay. Applied and Environmental Microbiology 35(1):136-141).

Title: National Primary Drinki ng Water Regulation: Revisions to the Total Coliform Rule Rule p. xxx of xxx List of Subjects
40 CFR Part 141 Environmental protection, Chemi cals, Indian-lands, Intergovernmental relations, Radiation protection, Reporting and recordkeep ing requirements, Water supply.
40 CFR Part 142 Environmental protection, Ad ministrative practice and procedure, Chemicals, Indianlands, Radiation protection, Reporting and recordkeeping requirements, Water supply.

Dated: ________________________________Document initiating EO 12866 review

223 ______________________________________ Lisa P. Jackson, Administrator

For the reasons set forth in the preamble, Title 40 chapter 1 of the Code of Federal Regulations is proposed to be amended as follows:

PART 141 - NATIONAL PRIMARY DRINKING WATER REGULATIONS

1. The authority citation for part 141 continues to read as follows:

Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g- 3, 300g-4, 300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.

2. Section 141.4 is revised to read as follows:

§ 141.4 Variances and exemptions. (a) Variances or exemptions from certain pr ovisions of these regula tions may be granted pursuant to sections 1415 and 1416 of the Act and subpart K of part 142 of this chapter (for small system variances) by the entity with primary enforcement responsibility, except thatDocument initiating EO 12866 review

224 variances or exemptions from the MCLs for total coliforms and E. coli and variances from any of the treatment technique requirements of subpa rt H of this part may not be granted. (b) EPA has stayed the effective date of this section relating to the total coliform MCL of §141.63(a) for systems that demonstrate to the State that the viola tion of the total coliform MCL is due to a persistent growth of total coliforms in the distribution system rather than fecal or pathogenic contamination, a treatment lapse or deficiency, or a problem in the operation or maintenance of the distribution system. This is stayed until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , at which time the total coliform MCL is no longer effective.

3. Section 141.13 is removed and reserved.

4. Section 141.21 is amended by adding paragraph (h) to read as follows:

§ 141.21 Coliform sampling. ***** (h) The provisions of paragraphs (a) and (d) are applicable until [INSERT DATE THREE
YEARS FOLLOWING PUBLICATI ON OF THE FINAL RULE] . The provisions of paragraphs (b), (c), (e), (f), and (g) are appl icable until all required repeat monitoring under paragraph (b) and fecal coliform or E. coli testing under paragraph (e) that was initiated by a total coliform-positive sample taken before [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] is completed, as well as analytical method,Document initiating EO 12866 review

225 reporting, recordkeeping, public notification, an d consumer confidence report requirements associated with that mon itoring and testing. After [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , the provisions of subpart Y of this part are applicable, with systems required to be gin regular monitoring at the same frequency as the frequency required on [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE]

.

5. Section 141.22 is removed and reserved.

6. Section 141.52 is revised to read as follows:

§ 141.52 Maximum contaminant level goals for microbiological contaminants. (a) MCLGs for the following contaminants are as indicated: Contaminant MCLG (1) Giardia lamblia ........................................ zero (2) Viruses .................................................... zero (3) Legionella ................................................ zero (4) Total coliforms (including fecal............zero coliforms and Escherichia coli ) (5) Cryptosporidium ...................................... zero (6) Escherichia coli (E. coli)..................... zeroDocument initiating EO 12866 review

226 (b) The MCLG identified in paragraph (a)(4) is applicable until [INSERT DATE THREE
YEARS FOLLOWING PUBLICATI ON OF THE FINAL RULE] . The MCLG identified in paragraph (a)(6) is applicable beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE]

.

7. Section 141.63 is revised to read as follows:

§ 141.63 Maximum contaminant levels (MCLs) for microbiological contaminants. (a) Until [INSERT DATE THREE YEARS FO LLOWING PUBLICATION OF THE FINAL RULE], the total coliform MCL is based on the pr esence or absence of total coliforms in a sample, rather than coliform density. (1) For a system that collects at least 40 samples per month, if no more than 5.0 percent of the samples collected during a month are total coliform-positive, the system is in compliance with the MCL for total coliforms. (2) For a system that collects fewer than 40 sa mples per month, if no more than one sample collected during a month is total coliform-positive, the system is in compli ance with the MCL for total coliforms. (b) Until [INSERT DATE THREE YEARS FOLLO WING PUBLICATION OF THE FINAL RULE] , any fecal coliform-positive repeat sample or E. coli -positive repeat sample, or any total coliform-positive repeat sample following a fecal coliform-positive or E. coli -positive routine sample, constitutes a violation of the MC L for total coliforms. For purposes of the public notification requirements in subpart Q of this part, this is a violat ion that may pose an acute risk to health.Document initiating EO 12866 review

227 (c) Beginning [INSERT DATE THREE YEARS FOLLO WING PUBLICATION OF THE FINAL RULE], a system is in compliance with the MCL for E. coli for samples taken under the provisions of subpart Y of this part unless any of the conditions identified in paragraphs (c)(1) through (c)(4) of this section occur. For purposes of the public notification requirements in subpart Q of this part, violation of the MCL may pose an acute risk to health. (1) The system has an E. coli -positive repeat sample following a total coliform-positive routine sample. (2) The system has a total coliform-positive repeat sample following an E. coli -positive routine sample. (3) The system fails to take all required repeat samples following an E. coli -positive routine sample. (4) The system fails to test for E. coli when any repeat sample tests positive for total coliform. (d) Until [INSERT DATE THREE YEARS FOLLO WING PUBLICATION OF THE FINAL RULE] , a public water system must determin e compliance with the MCL for total coliforms in paragraphs (a) and (b) of this se ction for each month in which it is required to monitor for total coliforms. Beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , a public water system must determine compliance with the MCL for E. coli in paragraph (c) of this section for each month in which it is required to monitor for total coliforms. (e) The Administrator, pursuant to section 1412 of the Act, here by identifies the following as the best technology, treatment techniques, or other means available for achieving compliance with the maximum contaminant level for total coliforms in paragraphs (a) and (b) of this section and for achieving compliance with the maximum contaminant level for E. coli in paragraph (c) of this section: (1) Protection of wells from fecal contamina tion by appropriate placement and construction; (2) Maintenance of a disinfectant resi dual throughout the distribution system;Document initiating EO 12866 review

228 (3) Proper maintenance of the distribution syst em including appropriate pipe replacement and repair procedures, main flushing programs, pr oper operation and maintenance of storage tanks and reservoirs, cross connection control, and continual maintenance of positive water pressure in all parts of the di stribution system; (4) Filtration and/or disinfection of surface water, as described in subparts H, P, T, and W of this part, or disinfection of ground water, as described in subpart S of this part, using strong oxidants such as chlorine, chlorine dioxide, or ozone; and (5) For systems using ground water, compliance with the requirements of an EPA-approved State Wellhead Protection Program developed and implemented under section 1428 of the SDWA.

8. Section 141.74 is amended by revising paragraphs (b)(6)(i) and (c)(3)(i) to read as follows:

§ 141.74 Analytical and monitoring requirements. ***** (b) *** (6)(i) Until [INSERT DATE THREE YEARS FOLLOWING PU BLICATION OF THE FINAL RULE] , the residual disinfectant c oncentration must be measur ed at least at the same points in the distribution system and at the same time as total coliforms are sampled, as specified in § 141.21. Beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , the residual disinfectant concentration must be measured at least at the same points in the distribution system and at the same time as total coliforms are sampled,as specified in §§ 141.854 through 141.857. The State may allow a public water system which uses both a surface water source or a ground water sour ce under direct influence of surface water, andDocument initiating EO 12866 review

229 a ground water source, to take disi nfectant residual samples at point s other than the total coliform sampling points if the State determines that su ch points are more repr esentative of treated (disinfected) water quality within the distributi on system. Heterotrophic bacteria, measured as heterotrophic plate count (HPC) as specified in pa ragraph (a)(1) of this section, may be measured in lieu of residual disi nfectant concentration.
***** (c) *** (3)(i) The residual disinfectant conc entration must be measured at least at the same points in the distribution system and at the same time as to tal coliforms are sampled, as specified in § 141.21, and as specified in §§ 141.854 through 141.857 beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , except that the State may allow a public water system which uses both a surface water source or a ground water source under direct influence of surface water, and a ground water source, to ta ke disinfectant residual samples at points other than the total coliform sampling point s if the State determines that such points are more representative of treated (disinfected) water quality within the distribution system. Heterotrophic bacteria, measured as heterotrophic plate count (HPC) as specified in paragraph (a)(1) of this section, may be measured in lieu of residual disi nfectant concentration.
*****

9. Section 141.132 is amended by revising para graph (c)(1)(i) to read as follows:

§ 141.132 Monitoring requirements. *****Document initiating EO 12866 review

230 (c) *** (1) *** (i) Routine monitoring. Until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], community and non-transient non-community water systems that use chlorine or chloramines mu st measure the residual disinfectant level in the distribution system at the same point in the distribution system and at the same time as total coliforms are sampled, as specified in § 141.21. Beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , c ommunity and non-transient noncommunity water systems that use chlorine or chloramines must measure the residual disinfectant level in the distributi on system at the same point in th e distribution system and at the same time as total coliforms are sampled, as specified in §§ 141.854 through 141.857. Subpart H systems may use the results of residual disi nfectant concentration sampling conducted under § 141.74(b)(6)(i) for unfiltered systems or § 141.74(c )(3)(i) for systems which filter, in lieu of taking separate samples.
*****

10. Section 141.153 is amended by revising the in troductory text to paragraph (d)(4)(vii), revising paragraph (d)(4)(viii), and adding paragraphs (d)(4)(x) and (d )(4)(xi) to read as follows:

§ 141.153 Content of the reports. ***** (d) *** (4) ***Document initiating EO 12866 review

231 (vii) For total coliform analytical results until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] : ***** (viii) For fecal coliform until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] : The total number of positive samples;
***** (x) For total coliform taken under subpart Y: (A) The number of Level 1 and Level 2 a ssessments required and completed; and (B) The corrective actions re quired and completed; and (xi) For E. coli : The total number of positive samples.
*****

11. In subpart O, Appendix A, the table is am ended by revising the entries for “Total Coliform Bacteria” and “Fecal Coliform and E. coli ,” adding a second entry for “Total Coliform Bacteria,” adding as a fourth entry “ E. coli ,” and adding two endnotes, to read as follows:
APPENDIX A TO SUBPART O OF PART 141 – REGULATED CONTAMINANTS

Contaminant (units) Traditional MCL in mg/L To convert for CCR, multipl y by MCL in CCR units MCLG Major sources in drinking

water Health effects language Microbiological contaminants: Total Coliform Bacteria † MCL (systems that collect ≥ 40 samples/month) 5% of monthly ........ MCL (systems that collect 0 Naturally present in the environment Coliforms are bacteria that are naturally present in the environment andDocument initiating EO 12866 review

232 samples are positive; (systems that collect <40 samples/month) 1 positive monthly sample ≥ 40 samples/ month) 5% of monthly samples are positive; (systems that collect <40 samples/ month) 1 positive monthly sample. are used as an indicator that other, potentially-harmful, bacteria may be present. Coliforms were found in more samples than allowed and this was a warning of potential problems.

Total Coliform Bacteria ‡ TT TT N/A Naturally present in the environment Coliforms are bacteria that are naturally present in the environment and are used as an indicator that other, potentially harmful, bacteria may be present. The water system found coliforms indicating the need to look for potential problems in water treatment or distribution. When this occurs, public water systems are required to conduct assessments to identify problems and to correct any problems that are found. [THE SYSTEM MUST USE THE FOLLOWING APPLICABLEDocument initiating EO 12866 review

233 SENTENCES.] The water system failed to conduct the required assessment(s). The water system failed to correct all identified sanitary defects. Fecal coliform and E. coli † 0 ......... 0 0 Human and animal fecal waste Fecal coliforms and E. coli are bacteria whose presence indicates that the water may be contaminated with human or animal wastes. Microbes in these wastes can cause short-term 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. E. coli ‡ Routine and repeat samples are totalcoliformpositive and either is E. coli

positive or system fails to take repeat samples following E. coli -positive routine sample or system fails ...... In complia nce unless one of the followin g conditio ns occurs: (1) The system has an 0 Human and animal fecal waste 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 effects, such as diarrhea, cramps, nausea, headaches, or other symptoms. They may pose aDocument initiating EO 12866 review

234 to analyze totalcoliformpositive repeat sample for E. coli E. coli

- positive repeat sample followin g a total coliform -positive routine sample. (2) The system has a total coliform -positive repeat sample followin g an E. coli

- positive routine sample. (3) The system fails to take all required repeat samples followin g an E. coli

- positive routine sample. (4) The system fails to test for E. coli when any repeat sample greater health risk for infants, young children, some of the elderly, and peoplewith severelycompromised immune systems.Document initiating EO 12866 review

235 tests positive for total coliform

. * * * * * * * ***** † Until [INSERT DATE THREE YEARS FO LLOWING PUBLICATION OF THE FINAL RULE]. ‡ Beginning [INSERT DATE THREE YEARS FOLLO WING PUBLICATION OF THE FINAL RULE]. *****
12. Section 141.202(a), Table 1, is amended by re designating entry (1) as entry (1)(i) and adding entry (1)(ii) to read as follows: § 141.202 Tier 1 Public Notice – Form, manner, and frequency of notice. *** TABLE 1 TO § 141.202 – VIOLATION CAT EGORIES AND OTHER SITUATIONS REQUIRING A TIER 1 PUBLIC NOTICE (1)(i) Violation of the MCL for tota l coliforms when fecal coliform or E. coli are present in the water distribution system (as specified in § 141.63(b)), or when the water system fails to test for fecal coliforms or E. coli when any repeat sample tests positive for coliform (as specified in § 141.21(e)); (1)(ii) Violation of the MCL for E. coli (as specified in §141.63(c)); * * * * * * *

13. Section 141.203(b)(2) is revised to read as follows:

§ 141.203 Tier 2 Public Notice – Form, manner, and frequency of notice ***** (b) ***Document initiating EO 12866 review

236 (2) The public water system must repeat the notice every three mont hs as long as the violation or situation persists, unless the primacy agency dete rmines that appropriate circumstances warrant a different repeat notice frequency. In no circ umstance may the repeat notice be given less frequently than once per year. It is not appropria te for the primacy agency to allow less frequent repeat notice for an MCL or treatment technique violation under the To tal Coliform Rule or subpart Y of this part or a treatment technique violation under the Surfac e Water Treatment Rule or Interim Enhanced Surface Water Treatment Rule. It is also not appropriate for the primacy agency to allow through its rules or policies ac ross-the-board reductions in the repeat notice frequency for other ongoing violations requiring a Tier 2 repeat notice. Primacy agency determinations allowing repeat notices to be gi ven less frequently than once every three months must be in writing.
*****

14. Section 141.204(a), Table 1, is amended by re vising entries 4 and 5 and adding entry 6 to read as follows:

§ 141.204 Tier 3 Public Notice – Form, manner, frequency of notice. (a) *** TABLE 1 TO § 141.204 – VIOLATION CAT EGORIES AND OTHER SITUATIONS REQUIRING A TIER 3 PUBLIC NOTICE * * * * * * * (4) Availability of unregulated contaminant m onitoring results, as required under § 141.207; (5) Exceedance of the fluoride secondary maximum contaminant level (SMCL), as required under § 141.208; and (6) Reporting violations under subpart Y of 40 CFR part 141.Document initiating EO 12866 review

237 *****
15. Appendix A to subpart Q is amended by rede signating and revising en tries I.A.1 as I.A.1.a and I.A.2 as I.A.2.a, adding new entries I.A.1.b and I.A.2.b, and adding two endnotes to read as follows:

APPENDIX A TO SUBPART Q OF PART 141 – NPDWR VIOLATIONS AND OTHER SITUATIONS REQUIRING PUBLIC NOTICE 1 MCL/MRDL/TT violations 2 Monitoring, testing & reporting procedure violations Contaminant

Tier of public notice required Citation Tier of public notice required Citation I. Violations of Na tional Primary Drinking Water Regulations (NPDWR): 3 A. Microbiological Contaminants 1.a Total coliform bacteria † 2 141.63(a) 3 141.21(a)-(e) 1.b Total coliform (TT violations resulting from failure to perform assessments or corrective actions) ‡ 2 141.860(b) 3 141.860(c)

2.a Fecal coliform/ E. coli † 1 141.63(b) 1,3 141.21(e) 2.b E. coli ‡ 1 141.63(c) 3 141.860(d)(2) * * * * * * * Appendix A—Endnotes † Until [INSERT DATE THREE YEARS FO LLOWING PUBLICATION OF THE FINAL RULE]. ‡ Beginning [INSERT DATE THREE YEARS FOLLO WING PUBLICATION OF THE FINAL RULE]. *****Document initiating EO 12866 review

238 16. Appendix B to subpart Q is amended by revi sing entries 1a and 1b, adding entries 1e and 1f, and adding two endnotes to read as follows:

APPENDIX B TO SUBPART Q OF PART 141 – STANDARDS HEALTH EFFECTS LANGUAGE FOR PUBLIC NOTIFICATION

Contaminant MCLG 1 mg/L MCL 2 mg/L Standard health effects language for public notification National Primary Drinking Wa ter Regulations (NPDWR) A. Microbiological Contaminants 1a. Total coliform † Zero See footnote 3 Coliforms are bacteria that are naturally present in the environment and are used asan indicator that other, potentiallyharmful, bacteria may be present. Coliforms were found in more samples than allowed and this was a warning of potential problems. 1b. Fecal coliform/ E. coli † Zero Zero Fecal coliforms and E. coli are bacteria whose presence indicates that the water may be contaminated with human or animal wastes. Microbes in these wastes can cause short-term 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. * * * * * * * 1e. Subpart Y Coliform Assessment and/or Corrective Action Violations ‡ N/A TT 3 Coliforms are bacteria that are naturally present in the environment and are used as an indicator that other, potentially harmful, bacteria may be present. The water system found coliforms indicating the need to look for potential problems in water treatment or distribution. When this occurs, public water systems are required to conduct assessments to identify problems and to correct any problems that are found. [THE SYSTEM MUST USE THEDocument initiating EO 12866 review

239 FOLLOWING APPLICABLE SENTENCES.] The water system failed to conduct the required assessment. The water system failed to correct all identified sanitary defects. 1f. E. coli ‡ Zero In compliance unless one of the following conditions occurs: (1) The system has an E. coli -positive repeat sample following a total coliform-positive routine sample. (2) The system hasa total coliformpositive repeat sample following an E. coli -positive routine sample. (3) The system fails to take all required repeat samples following an E. coli -positive routine sample. (4) The system fails to test for E. coli when any repeat sample tests positive for total coliform. 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 effects, such as diarrhea, cramps, nausea, headaches, or other symptoms. They may pose a greater health risk for infants, young children, some of the elderly, and people with severely compromised immune systems.

* * * * * * *

Appendix B—Endnotes † Until [INSERT DATE THREE YEARS FO LLOWING PUBLICATION OF THE FINAL RULE] ‡ Beginning [INSERT DATE THREE YEARS FOLLO WING PUBLICATION OF THE FINAL RULE]Document initiating EO 12866 review

240 *****
17. Section 141.402 is amended by revising paragraph (a) to read as follows: § 141.402 Ground water source microbial moni toring and analytical methods. (a) Triggered source water monitoring — (1) General requirements. A ground water system must c onduct triggered source water monitoring if the conditions identified in paragraphs (a)(1)(i) and either (a)(1 )(ii) or (a)(1)(iii) of this section exist. (i) The system does not provide at least 4-log tr eatment of viruses (using inactivation, removal, or a State-approved combination of 4-log virus in activation and removal) be fore or at the first customer for each ground water source; and either (ii) The system is notified that a sample coll ected under § 141.21(a) is total coliform-positive and the sample is not invalidated under § 141.21(c) until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , or (iii) The system is notified that a sample collected under §§ 141.854 through 141.857 is total coliform-positive and the sample is not invalidated under § 141.853 beginning [INSERT DATE
THREE YEARS FOLLOWING PUBLI CATION OF THE FINAL RULE]

. (2) Sampling requirements. A ground water system must coll ect, within 24 hours of notification of the total coliform-positive sample, at leas t one ground water source sample from each ground water source in use at the time the total coli form-positive sample was collected under § 141.21(a) until [INSERT DATE THREE YEARS FOLLOW ING PUBLICATION OF THE FINAL RULE] , or collected under §§ 141.854 through 141.857 beginning [INSERT DATE THREE
YEARS FOLLOWING PUBLICATI ON OF THE FINAL RULE] , except as provided in paragraph (a)(2)(ii) of this section.Document initiating EO 12866 review

241 (i) The State may extend the 24-hour time limit on a case-by-case basis if the system cannot collect the ground water source water sample w ithin 24 hours due to circumstances beyond its control. In the case of an extension, the State must specify how much time the system has to collect the sample. (ii) If approved by the State, systems with mo re than one ground wate r source may meet the requirements of this paragraph (a)(2) by samp ling a representative ground water source or sources. If directed by the State, systems must submit for State approval a triggered source water monitoring plan that identifies one or more ground water sources that are representative of each monitoring site in the system’s sa mple siting plan under § 141.21(a) until [INSERT DATE
THREE YEARS FOLLOWING PUBLI CATION OF THE FINAL RULE] , or under § 141.853 beginning [INSERT DATE THREE YEARS FO LLOWING PUBLICATION OF THE FINAL RULE] , and that the system intends to use for representative sampling under this paragraph. (iii) Until [INSERT DATE THREE YEARS FOLLO WING PUBLICATION OF THE FINAL RULE] , a ground water system serving 1,000 or fewer people may use a repeat sample collected from a ground water source to meet both the requirements of § 141.21(b) and to satisfy the monitoring requirements of pa ragraph (a)(2) of this section for that ground water source only if the State approves the use of E. coli as a fecal indicator for sour ce water monitoring under this paragraph (a). If the repeat sample co llected from the ground water source is E. coli -positive, the system must comply with para graph (a)(3) of this section. (iv) Beginning [INSERT DATE THREE YEARS FOLLO WING PUBLICATION OF THE FINAL RULE] , a ground water system serving 1,000 or fewer people may use a repeat sample collected from a ground water source to meet both the requirements of subpart Y and to satisfyDocument initiating EO 12866 review

242 the monitoring requirements of pa ragraph (a)(2) of this section for that ground water source only if the State approves the use of E. coli as a fecal indicator for s ource water monitoring under this paragraph (a) and approves the use of a single sample for meeting both the triggered source water monitoring requirements in this paragraph (a) and the repeat monitoring requirements in § 141.858. If the repeat sample collected from the ground water source is E. coli - positive, the system must comply with para graph (a)(3) of this section. (3) Additional requirements. If the State does not re quire correctiv e action under § 141.403(a)(2) for a fecal indicator-positive source water sample collected under paragraph (a)(2) of this section that is not inva lidated under paragraph (d) of this section, the system must collect five additional source water samples from the same source within 24 hours of being notified of the fecal indicator-positive sample. (4) Consecutive and wholesale systems — (i) In addition to the other requi rements of this paragraph (a), a consecutive ground water system that has a total coliform-positive sample collected under § 141.21(a) until [INSERT DATE
THREE YEARS FOLLOWING PUBLI CATION OF THE FINAL RULE] , or under §§ 141.854 through 141.857 beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , must notify the wholesale system(s) within 24 hours of being notified of the total coliform-positive sample. (ii) In addition to the other requirements of th is paragraph (a), a wholesale ground water system must comply with paragraphs (a)(4)(ii) (A) and (a)(4)(ii)(B) of this section. (A) A wholesale ground water system that receiv es notice from a consecutive system it serves that a sample collected under § 141.21(a) until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , or collected under §§ 141.854Document initiating EO 12866 review

243 through 141.857 beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , is total coliform-positive must, within 24 hours of being notified, collect a sample from its ground water source(s) under paragraph(a )(2) of this section and analyze it for a fecal indicator under paragr aph (c) of this section. (B) If the sample collected unde r paragraph (a)(4)(ii)(A ) of this section is fecal indicatorpositive, the wholesale ground water system must notify all consecutive systems served by that ground water source of the fecal indicator source wa ter positive within 24 hours of being notified of the ground water source sample monitoring result and must meet the requirements of paragraph (a)(3) of this section. (5) Exceptions to the triggered source water monitoring requirements. A ground water system is not required to comply with the source water m onitoring requirements of paragraph (a) of this section if either of the following conditions exists: (i) The State determines, and documents in writing, that the total coliform-positive sample collected under § 141.21(a) until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , or under §§ 141.854 through 141.857 beginning [INSERT DATE THREE YE ARS FOLLOWING PUBLI CATION OF THE FINAL RULE] , is caused by a distribution system deficiency; or (ii) The total coliform-positive sample collected under § 141.21(a) until [INSERT DATE
THREE YEARS FOLLOWING PUBLI CATION OF THE FINAL RULE] , or under §§ 141.854 through 141.857 beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , is collected at a locati on that meets State criteria for distribution system conditions that will cause total coliform-positive samples.
*****Document initiating EO 12866 review

244 18. Section 141.405 is amended by revising pa ragraph (b)(4) to read as follows: § 141.405 Reporting and recordkeeping for ground water systems. ***** (b) *** (4) For consecutive systems, docum entation of notification to the wholesale system(s) of total coliform-positive samples that are not invalidated under § 141.21(c) until [INSERT DATE
THREE YEARS FOLLOWING PUBLI CATION OF THE FINAL RULE] , or under § 141.853 beginning [INSERT DATE THREE YEARS FO LLOWING PUBLICATION OF THE FINAL RULE] . Documentation shall be kept for a period of not less than five years.
*****

19. Section 141.803 is amended by revising paragraphs (a)(3) and (a)(5) to read as follows: § 141.803 Coliform sampling. (a) *** (3) Air carriers must conduct analyses for total coliform and E. coli in accordance with the analytical methods approved in §§ 141.21(f)(3) and 141.21(f)(6) ) until [INSERT DATE
THREE YEARS FOLLOWING PUBLI CATION OF THE FINAL RULE] , and under § 141.852 beginning [INSERT DATE THREE YEARS FO LLOWING PUBLICATION OF THE FINAL RULE]

. ***** (5) The invalidation of a total coliform sample result can be made only by the Administrator in accordance with §§ 141.21(c)(1)(i), (ii) , or (iii) or by the certified laboratory in accordance withDocument initiating EO 12866 review

245 § 141.21(c)(2) until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , or in accordance with § 141.853(c) beginning [INSERT DATE THREE
YEARS FOLLOWING PUBLICATI ON OF THE FINAL RULE ], with the Administrator acting as the State.
*****

20. Part 141 is amended by adding a ne w subpart Y to read as follows:

Subpart Y - Revised Total Coliform Rule

Sec. 141.850 General. 141.851 Definitions. 141.852 Analytical methods and laboratory certification. 141.853 General monitoring requirements for all public water systems. 141.854 Routine monitoring requirements for non-community water systems serving 1,000 or fewer people using only ground water. 141.855 Routine monitoring requirements for comm unity water systems serving 1,000 or fewer people using only ground water. 141.856 Routine monitoring requirements for su bpart H public water systems serving 1,000 or fewer people. 141.857 Routine monitoring requirements for pu blic water systems serving more than 1,000 people.Document initiating EO 12866 review

246 141.858 Repeat monitoring and E. coli requirements. 141.859 Coliform treatment technique requirements for protection against potential fecal contamination. 141.860 Violations. 141.861 Reporting and recordkeeping.

Subpart Y - Revised Total Coliform Rule

§ 141.850 General. (a) General . The provisions of this subpart incl ude both maximum contaminant level and treatment technique requirements. (b) Applicability . The provisions of this subpart apply to all public water systems. (c) Compliance date . Systems must comply with the pr ovisions of this subpart beginning [INSERT DATE THREE YE ARS FOLLOWING PUBLI CATION OF THE FINAL RULE] , unless otherwise specified in this subpart.

§ 141.851 Definitions. Clean compliance history is, for the purposes of subpart Y, a record of no MCL violations under §141.63; no monitoring violations under §141.21 or subpart Y; and no treatment technique trigger exceedances or treatment t echnique violations under subpart Y. Sanitary defect is a defect that could provide a pathway of entry for microbial contamination into the distribution system or that is indicative of a failure or imminent failure in a barrier that is already in place.Document initiating EO 12866 review

247 Seasonal system is a non-community water system that is operated three or fewer calendar quarters per calendar year.

§ 141.852 Analytical methods and laboratory certification.

(a) Analytical methodology . (1) The standard sample volume required for analysis, regardless of analytical method used, is 100 ml. (2) Systems need only determine the presence or absence of total coliforms and E. coli ; a determination of density of either is not required. (3) The time from sample collection to initia tion of test medium incubation may not exceed 30 hours. Systems are encouraged but not required to hold samples below 10 deg. C during transit. (4) If chlorinated water is to be analyzed, sufficient sodium thiosulfate (Na 2 S 2 O 3 ) must be added to the sample bottle before sterilization to neutralize any residual chlorine in the water sample. Dechlorination procedures are addressed in Section 9060A.2 of Standard Methods for the Examination of Water and Wastewater (20 th and 21 st editions). (5) Systems must conduct to tal coliform analyses in accordan ce with one of the analytical methods in the following table or one of the a lternative methods listed in Appendix A to subpart C of part 141.

Organism Methodology Category Method 1 Citation
Total Coliforms Total Coliform Multiple Tube Fermentation Technique 9221 B.1, B.2 1, 2 Lactose Fermentation Methods Presence-Absence (P-A) Coliform Test 9221 D.1, D.2 1, 12Document initiating EO 12866 review

248 Total Coliform Membrane Filter Technique 9222 B, C 1, 3 Membrane Filtration using MI medium EPA Method 1604 3, 4 Membrane Filtration Methods
m-ColiBlue24® Test 3, 5 Chromocult 3, 6
Colilert® 9223 B 1, 7 Colisure® 9223 B 1, 7, 8 E*Colite® Test 9 Readycult® Test 10 Enzyme Substrate Methods

modified Colitag® Test 11

Escherichia coli Escherichia coli Procedure (following Lactose Fermentation

Methods) EC-MUG medium 9221 F.1 1

Escherichia coli Partition Method EC broth with MUG (ECMUG) 9222 G.1 a (2) 1, 13
NA-MUG medium 9222 G.1 a (1) 1 Membrane Filtration using MI medium EPA Method 1604 3, 4 Membrane Filtration Methods m-ColiBlue24® Test 3, 5 Chromocult 3, 6
Colilert® 9223 1, 7 Colisure® 9223 1, 7, 8 E*Colite® Test 9 Readycult® Test 10 Enzyme Substrate Methods

modified Colitag® Test 11 The procedures must be done in accordance with the documents listed below. For vendor methods, the date of the method listed here is the date/version of the approved method. The methods listed are the only versions that may be used for compliance with this rule. Laboratories should be careful to use only the approved versions of the methods, as product package inserts may not be the same as the approved versions of the methods. The Director of the Federal Register approved the incorp oration by reference of the documents listed in footnotes 1, 4, 5, 6, 9, 10, and 11 in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51.Document initiating EO 12866 review

249 Copies of the documents may be obtained from the sources listed below. Information regarding these documents can be obtained from the Safe Drinking Water Hotline, telephone (800) 426-4791. Documents may be reviewed at EPA's Drinking Water Docket, EPA West, 1301 Constitution Av enue, NW, EPA West, Room B102, Washington, DC 20460 (Telephone: 202-566-2426); or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibrlocations.html.

1 Methods are described in Standard Methods for the Ex amination of Water and Wastewater , 20 th edition (1998), or 21 st edition (2005). American Public Health Association, 800 I Street, NW, Washingt on, DC 20001. The cited methods published in either of these two editions may be used. In addition, the following online versions may also be used: 9221 B.1, B.2-99, D.1, D.2-99, 9222 B-97, 9222 C-97, and 9223 B-97. Standard Methods Online is available at http://www.standardmethods.org . The year in which each method was approved by the Sta ndard Methods Committee is designated by the last two digits followi ng the hyphen in the method number. The methods listed are the only online versions that may be used.

2 Lactose broth, as commercially available, may be used in lieu of lauryl tryptose broth, if the system conducts at least 25 parallel test s between lactose brot h and lauryl tryptose broth using the water normally tested, a nd if the findings from this comparison demonstrate that the false-positive rate and false-negative rate for total coliforms, using lactose broth, is less than 10 percent.

3 All filtration series must begin with me mbrane filtration equipment that has been sterilized by autoclaving. E xposure of filtration equipment to UV light is not adequate to ensure sterilization. Subsequent to the in itial autoclaving, exposu re of the filtration equipment to UV light may be used to sanitiz e the funnels between filtrations within a filtration series.

4 EPA Method 1604: Total Coliforms and Escherichia coli in Water by Membrane Filtration Using a Simultaneous Detection Technique (MI Medium); September 2002, EPA 821-R-02-024. The method is available at http://www.epa.gov/nerlcwww/1604sp02.pdf or from EPA’s Water Re source Center (RC4100T), 1200 Pennsylvania Avenue, NW, Washington, DC 20460.

5 The m-ColiBlue24® test is described in the document “Membrane Filtration Method mColiBlue24® Broth, Revision 2, August 17, 199 9”, available from the Hach Company, P.O. Box 389, Loveland, CO 80539.

6 The Chromocult test is described in th e document “Chromocult® Coliform Agar Presence/Absence Membrane Filter Test Me thod for Detection and Identification of Coliform Bacteria and Escherichia coli in Finished Waters,” November 2000, Version 1.0, available from EMD Chemicals (an affiliate of Merck KGaA, Darmstadt Germany), 480 S. Democrat Road, Gibbstown, NJ 08027-1297. (Telephone (800) 222-0342).Document initiating EO 12866 review

250 7 Multiple-tube and multi-well enumerative formats for this method are approved for use in presence-absence determination under this regulation.

8 Colisure® results may be read af ter an incubation time of 24 hours.

9 The E*Colite® test is described in the document “Charm E*Colite TM Presence/Absence Test for Detection and Identification of Coliform Bacteria and Escherichia coli in Drinking Water”, January 9, 1998, available from Charm Sciences, Inc., 659 Andover Street, Lawrence, MA 01843-1032.

10 The Readycult® test is described in the document “Readycult® Coliforms 100 Presence/Absence Test for Detection and Identification of Coliform Bacteria and Escherichia coli in Finished Waters, January 2007, Version 1.1,” available from EMD Chemicals (an affiliate of Merck KGaA, Da rmstadt Germany), 480 S. Democrat Road, Gibbstown, NJ 08027-1297. (Telephone ( 800) 222-0342). Internet address http://www.readycult.com.

11 The Colitag® test is described in the document “Modified Colitag TM Test Method for the Simultaneous Detection of E. coli and other Total Coliforms in Water,” August 28, 2009, available from CPI International, Inc., 5580 Skylane Blvd., Santa Rosa, CA, 95403. (Telephone (800) 878-7654, Fax (707) 545-7901). Internet address http://www.cpiinternational.com

.
12 A multiple tube enumerative format, as described in Standard Methods for the Examination of Water and Wastewater 9221, is approved for this method for use in presence-absence determination under this regulation.

13 The following changes must be made to the EC broth with MUG (EC-MUG) formulation: Potassi um dihydrogen phosphate, KH 2 PO 4 , must be 1.5g, and 4- methylumbelliferyl-Beta-D-glucuronide must be 0.05 g.
(b) Laboratory certification . Systems must have all complia nce samples required under this subpart analyzed by a laborator y certified by the EPA or a prim acy State to analyze drinking water samples. The laboratory used by the sy stem must be certified for each method and contaminant used for compliance monitoring under this rule.

§ 141.853 General monitoring requiremen ts for all public water systems.Document initiating EO 12866 review

251 (a) Sample siting plans . (1) Systems must develop a written sample siting plan that identifies sampling sites and a sample collection schedule th at are representative of water throughout the distribution system not later than [INSERT DATE THREE YEAR S AFTER PUBLICATION OF FINAL RULE] . Systems must collect total coliform samples according to the written sample siting plan. These plans are subject to State review and revision. Monitoring required by §§ 141.854 through 141.858 may take place at a custome r’s premise, dedicated sampling station, or other designated compliance sampling location. Routine and repeat sample sites and any sampling points necessary to meet the requireme nts of subpart S must be reflected in the sampling plan. (2) Systems must collect samples at regular time intervals throughout th e month, except that systems that use only ground water and serve 4, 900 or fewer people may collect all required samples on a single day if they ar e taken from different sites. (3) A system may conduct more monitoring than is required by this s ubpart to investigate potential problems in the distribut ion system and use monitoring as a tool to assist in uncovering problems. A system may take more than the minimum number of required routine samples and include the results in calculating whether the coliform treatment tec hnique trigger has been exceeded only if the samples are taken in accordan ce with the existing sample siting plan and are representative of water throughout the distribution system. (4) Systems must identify repeat monitoring locations in the sample siting plan. Unless the provisions of paragraphs (a )(4)(i) or (a)(4)(ii) of this section are met, the system must collect at least one repeat sample from the sampling tap where the original total coliform-positive sample was taken, and at least one repeat sample at a ta p within five service connections upstream and at least one repeat sample at a tap within five service connections downstream of the originalDocument initiating EO 12866 review

252 sampling site. If a total coliform-positive sample is at the end of the distribution system, or one service connection away from the end of the distribution system, the State may waive the requirement to collect at least one repeat sa mple upstream or downstream of the original sampling site. Except as provided for in paragraph (a)(4)(ii) of this section, systems required to conduct triggered source water monitoring under § 141.402(a) must take ground water source sample(s) in addition to repeat samples required under this subpart. (i) Systems may propose repeat monitoring locations to the State that the system believes to be representative of a pathway for contamination of the distribution system. A system may elect to specify either alternative fixed locations or criteria for selecting repeat sampling sites on a situational basis in a standard operating procedure (SOP) in its sample siting plan. The system must design its SOP to focus the repeat samples at locations that best verify and determine the extent of potential contaminati on of the distribution system ar ea based on specific situations. The State may modify the SOP as needed. (ii) Ground water systems servi ng 1,000 or fewer people may propose repeat sampling locations to the State that differentiate potential source water and distri bution system contamination (e.g. by sampling at entry points to the distribution system). A ground water system required to conduct triggered source water monitoring may, w ith written State approv al, take one of its repeat samples at the monitoring location requi red for triggered source water monitoring under § 141.402(a) if the system demonstrates to the Stat e’s satisfaction that the sample siting plan remains representative of water quality in the dist ribution system. If approved by the State, the system may use that sample result to meet th e monitoring requirements in both § 141.402(a) and this section.Document initiating EO 12866 review

253 (A) If a sample taken at the monitoring locat ion required for triggere d source water monitoring is E. coli -positive, the system has violated the E. coli MCL and must also comply with § 141.402(a)(3). If a system with a limited number of monitoring locations takes more than one repeat sample at the monitoring location requir ed for triggered source water monitoring, the system may reduce the number of additio nal source water samples required under § 141.402(a)(3) by the number of repeat samples taken at that location that were not E. coli

positive. (B) If a system with a limite d number of monitoring locations takes more than one repeat sample at the monitoring location required for triggered source water monitoring under § 141.402(a), and more than one repeat sample is E. coli -positive, the system has violated the E. coli MCL and must also comply with § 141.403(a)(1). (5) States may review, revise, and approve, as necessary, repeat samp ling proposed by systems under paragraphs (a)(4)(i) and (ii) of this secti on. The system must demo nstrate to the State’s satisfaction that the sample siting plan remain s representative of th e water quality in the distribution system. The State may determine that monitoring at the entry point to the distribution system (especially for undisinf ected ground water systems) is effective to differentiate between potential source water and distribution system problems. (b) Special purpose samples. Special purpose samples, such as those taken to determine whether disinfection practices are sufficient following pipe placement, replacement, or repair, must not be used to determine whether the coliform treatment technique trigger has been exceeded. Repeat samples taken pursuant to § 141.858 are not considered special purpose samples, and must be used to determine whethe r the coliform treatment technique trigger has been exceeded.Document initiating EO 12866 review

254 (c) Invalidation of total coliform samples . A total coliform-positive sample invalidated under this paragraph (c) of this s ection does not count toward meeting the minimum monitoring requirements of this subpart. (1) The State may invalidate a total co liform-positive sample only if the conditions of paragraph (c)(1)(i), (ii), or (i ii) of this section are met. (i) The laboratory establishes that improper sample analysis caused the total coliform-positive result. (ii) The State, on the basis of the results of repeat samples collected as required under § 141.858(a), determines that the total coliform-positiv e sample resulted from a domestic or other non-distribution system plumbing pr oblem. The State cannot invalida te a sample on the basis of repeat sample results unless all repeat sample(s) collected at the same tap as the original total coliform-positive sample are also total coliform-pos itive, and all repeat samples collected within five service connections of th e original tap are total colifo rm-negative (e.g., a State cannot invalidate a total coliform-positive sample on the ba sis of repeat samples if all the repeat samples are total coliform-negative, or if the system has only one service connection). (iii) The State has substantial grounds to be lieve that a total coliform-positive result is due to a circumstance or condition that does not reflect wa ter quality in the distribution system. In this case, the system must still collect all repeat samples required under § 141.858(a), and use them to determine whether a coliform treatment tec hnique trigger in § 141.859 has been exceeded. To invalidate a total coliform-positive sample unde r this paragraph, the decision and supporting rationale must be documented in writing, and ap proved and signed by the supervisor of the State official who recommended the decision. The Stat e must make this document available to EPA and the public. The written documentation must st ate the specific cause of the total coliform-Document initiating EO 12866 review

255 positive sample, and what action the system has taken, or will take, to correct this problem. The State may not invalidate a total coliform-positive sample solely on the grounds that all repeat samples are total coliform-negative. (2) A laboratory must invalidate a total colif orm sample (unless total coliforms are detected) if the sample produces a turbid cultu re in the absence of gas produc tion using an analytical method where gas formation is examined (e.g., the Mult iple-Tube Fermentation Technique), produces a turbid culture in the absence of an acid reaction in the Presence-Absence (P-A) Coliform Test, or exhibits confluent growth or produces colonies to o numerous to count with an analytical method using a membrane filter (e.g., Memb rane Filter Technique). If a laboratory invalidates a sample because of such interference, the system must co llect another sample from the same location as the original sample within 24 hours of being not ified of the interferen ce problem, and have it analyzed for the presence of total coliforms. Th e system must continue to re-sample within 24 hours and have the samples analyzed until it obta ins a valid result. The State may waive the 24- hour time limit on a case-by-case basis.

§ 141.854 Routine monitoring requirements for non-community water systems serving 1,000 or fewer people using only ground water. (a) General . (1) The provisions of this section apply to non-community water systems using only ground water (except ground water under the direct influence of surface water, as defined in § 141.2) and serving 1,000 or fewer people. (2) Following any total coliform-positive sample taken under the provisions of this section, systems must comply with the re peat monitoring requirements and E. coli analytical requirements in § 141.858.Document initiating EO 12866 review

256 (3) Once all monitoring required by this sec tion and § 141.858 for a calendar month has been completed, systems must determine whether any co liform treatment technique triggers specified in § 141.859 have been exceeded. If any trigger has been exceeded, systems must complete assessments as required by § 141.859. (b) Monitoring frequency for total coliforms . Systems must monitor each calendar quarter that the system provides water to the public, except for seasonal systems or as provided under paragraphs (c) though (h) and (j) of this secti on. Seasonal systems must meet the monitoring requirements of paragra ph (i) of this section. (c) Transition to subpart Y . (1) Systems, including seasonal sy stems, must continue to monitor according to the total coliform monitoring schedules under § 141.21 that were in effect on [INSERT DATE THREE YE ARS AFTER PUBLICATION OF THE FINAL RULE] unless any of the conditions for increased monitoring in paragraph (f) of this section are triggered on or after [INSERT DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE] or unless otherwise directed by the State. (2) After [INSERT DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE] , the State must perform a special monitoring evaluation during each sanitary survey to review the status of the system, including the distribution system, to determine whether the system is on an appropriate monitoring schedule. After the State has performed the special monitoring evaluation during each sanitary survey, the Stat e may modify the system’s monitoring schedule as necessary. For seasonal systems on quarterly or annual monitoring, this evaluation must include review of the approved sample siting plan, which must designate the time period(s) for monitoring based on site-specifi c considerations (e.g. dur ing periods of highestDocument initiating EO 12866 review

257 demand or highest vulnerability to contamination). The seasonal system must collect compliance samples during these time periods. (d) Annual site visits. Beginning no later than [INSERT DATE FOUR YEARS AFTER PUBLICATION OF THE FINAL RULE] , systems on annual monitoring, including seasonal systems, must have an initial and recurring annual site visit by the State or an annual voluntary Level 2 assessment by a party approved by th e State to remain on annual monitoring. (e) Reduced monitoring provisions . Beginning [INSERT DATE THR EE YEARS AFTER PUBLICATION OF THE FINAL RULE] , the State may reduce the monitoring frequency for a well-operated ground water system from quarter ly routine monitoring to no less than annual monitoring, if the system demons trates that it meets the criteri a for reduced monitoring in paragraphs (e)(1) through (e)(3) of this section, except for a syst em that has been on increased monitoring under the provisions of paragraph (f) of this sect ion. A system on increased monitoring under paragraph (f) of th is section must meet the provisi ons of paragraph (g) of this section to go to quarter ly monitoring and must meet the pr ovisions of paragraph (h) of this section to go to annual monitoring. (1) The most recent sanitary survey shows that the system is free of sanitary defects, has a protected water source, and meets approved construction standards; (2) The system has a clean compliance history for a minimum of 12 months; and (3) The State has conducted an annual site visit (recurring) w ithin the last 12 months and the system has corrected all identified sanitary defects. The system may substitute a Level 2 assessment by a party approved by the State for the State annual site visit. (f) Increased Monitoring Requirements . A system on quarterly or annual monitoring that experiences any of the events id entified in paragraphs (f)(1) thr ough (f)(4) of this section mustDocument initiating EO 12866 review

258 begin monthly monitoring the month following the event. The system must continue monthly monitoring until the requirements in paragraph (g ) of this section for quarterly monitoring or paragraph (h) of this section for annual monitori ng are met. A system on monthly monitoring for reasons other than those iden tified in paragraphs (f)(1) through (f)(4) of this section is not considered to be on increased monitoring for th e purposes of paragraphs (g) and (h) of this section. (1) The system triggers a Level 2 assessment or two Level 1 assessments in a rolling 12 month period. (2) The system has an E. coli MCL violation. (3) The system has a coliform treatment technique violation. (4) The system has two subpart Y monitoring vi olations in a rolling 12-month period for a system on quarterly monitoring or one subpart Y monitoring violation for a system on annual monitoring. (g) Requirements for returning to quarterly monitoring . To be eligible to return to quarterly monitoring from monthly monitoring triggered under paragraph (f) of this section, a system on increased monitoring under paragraph (f) of this section must meet the cr iteria in paragraphs (g)(1) and (g)(2) of this section. (1) Within the last 12 months, the system must ha ve a completed sanitary survey or a site visit by the State or a voluntary Level 2 assessment by a party approved by the State, be free of sanitary defects, and have a protected water source; and (2) The system must have a clean complia nce history for a minimum of 12 months.Document initiating EO 12866 review

259 (h) Requirements for annual monitoring . To be eligible for annual monitoring, a system on increased monitoring under paragrap h (f) of this section must meet the criteria in paragraph (g) of this section plus the criteria in para graphs (h)(1) and (h)( 2) of this section. (1) An annual site visit (recurring) by the State and correction of all identi fied sanitary defects. The system may substitute a voluntary Level 2 assessment by a party approved by the State for the State annual site visit in any given year. (2) The system must adopt one or more additiona l enhancements to the water system barriers to contamination in paragraphs (h)(2)(i ) through (h)(2)(v) of this section. (i) Cross connection control, as approved by the State. (ii) An operator certified by an appropriate State certification program, which may include regular visits by a circuit rider. (iii) Continuous disinfection ente ring the distribution system and a residual in the distribution system in accordance with criteria specified by the State. (iv) Demonstration of maintenance of at leas t a 4-log removal or inact ivation of viruses as provided for under § 141.403(b)(3). (v) Other equivalent enhancements to wate r system barriers as approved by the State. (i) Seasonal systems . (1) Beginning [INSERT DATE THR EE YEARS AFTER PUBLICATION OF THE FINAL RULE] , all seasonal systems must demonstrate completion of a State-approved start-up procedure, which ma y include a requirement for a startup sample prior to serving water to the public. (2) Seasonal systems have a routine monitoring frequency of monthly. (3) A seasonal system must meet the criteria in pa ragraphs (i)(3)(i) through (iii) of this section to be eligible for monitoring less frequently than monthly after [INSERT DATE THREE YEARSDocument initiating EO 12866 review

260 AFTER PUBLICATION OF FINAL RULE] , except as provided under paragraph (c) of this section. (i) The seasonal system must have an approved sample siting plan that designates the time period for monitoring based on site-speci fic considerations (e.g. during periods of highest demand or highest vulnerability to contamin ation). The system must collect compliance samples during this time period. (ii) To be eligible for reduced quarterly m onitoring, the system must meet the criteria in paragraph (g) of this section. (iii) To be eligible for redu ced annual monitoring, the system must meet the criteria under paragraph (h) of this section. (j) Additional routine monitoring . Systems collecting samples on a quarterly or annual frequency must conduct additional routine monito ring the month following one or more total coliform-positive samples (with or without a Level 1 treatment tec hnique trigger). Systems must collect at least three routine samples during the next month, except that the State may waive this requirement if the conditions of pa ragraph (j)(1), (2), or (3) of th is section are met. Systems may either collect samples at regular time interval s throughout the month or may collect all required routine samples on a single day if samples are take n from different sites. Systems must use the results of additional routine samples in coliform treatment technique trigger calculations. (1) The State may waive the requirement to collect three routine samples the next month in which the system provides water to the public if the State, or an agent approved by the State, performs a site visit before the end of the next month in which the system provides water to the public. Although a sanitary survey need not be pe rformed, the site visit must be sufficiently detailed to allow the State to determine whet her additional monitoring and/or any correctiveDocument initiating EO 12866 review

261 action is needed. The State cannot approve an employ ee of the system to perform this site visit, even if the employee is an agent approved by the State to perform sanitary surveys. (2) The State may waive the requirement to collect three routine samples the next month in which the system provides water to the public if the State has determined why the sample was total coliform-positive and has established that the system has corrected the problem or will correct the problem before the end of the next month in which the system serves water to the public. In this case, the State must document this decision to waive the following month's additional monitoring requirement in writing, have it approved and signed by the supervisor of the State official who recommends such a decisi on, and make this document available to the EPA and public. The written documentation must describe the specific cause of the total coliform-positive sample and what action the system has taken and/or will take to correct this problem. (3) The State may not waive the requirement to collect three additional routine samples the next month in which the system provides water to th e public solely on the grounds that all repeat samples are total coliform-negative. If the Stat e determines that the system has corrected the contamination problem before the system take s the set of repeat samples required in §141.858, and all repeat samples were total coliform-nega tive, the State may waive the requirement for additional routine mon itoring the next month.

§ 141.855 Routine monitoring requirements for community water systems serving 1,000 or fewer people using only ground water.Document initiating EO 12866 review

262 (a) General . (1) The provisions of this section a pply to community water systems using only ground water (except ground water under the direct influence of surface wa ter, as defined in §141.2) and serving 1,000 or fewer people. (2) Following any total coliform-positive sample taken under the provisions of this section, systems must comply with the re peat monitoring requirements and E. coli analytical requirements in § 141.858. (3) Once all monitoring required by this sec tion and § 141.858 for a calendar month has been completed, systems must determine whether any co liform treatment technique triggers specified in § 141.859 have been exceeded. If any trigger has been exceeded, systems must complete assessments as required by § 141.859. (b) Monitoring frequency for total coliforms . The monitoring frequency for total coliforms is one sample/month, except as provided for under paragraphs (c) through (f) of this section. (c) Transition to subpart Y . (1) All systems must continue to monitor according to the total coliform monitoring schedules under § 141.21 that were in effect on [INSERT DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE] unless any of the conditions in paragraph (e) of this secti on are triggered on or after [INSERT DATE THREE YEARS
AFTER PUBLICATION OF THE FINAL RULE] or unless otherwise directed by the State. (2) After [INSERT DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE] , the State must perform a special monitoring evaluation during each sanitary survey to review the status of the system, including the distribution system, to determine whether the system is on an appropriate monitoring schedule. After the State has performed the special monitoring evaluation during each sanitary survey, the Stat e may modify the system’s monitoring schedule as necessary.Document initiating EO 12866 review

263 (d) Reduced monitoring requirements . (1) The State may reduce the monitoring frequency from monthly monitoring to no less than quarterly m onitoring if the system is in compliance with State certified operator provision s and demonstrates that it m eets the criteria in paragraphs (d)(1)(i) through (d)(1 )(iii) of this section. A system that loses its certified ope rator must return to monthly monitoring the month following that loss. (i) The most recent sanitary survey shows the sy stem is free of sanitary defects (or has an approved plan and schedule to correct them), has a protected water source and meets approved construction standards. (ii) The system has a clean complian ce history for a minimum of 12 months. (iii) The system meets at least one of the following criteria: (A) An annual site visit by the State or a Leve l 2 assessment by a party approved by the State and correction of all identified sanitary defects (or an approved plan and sche dule to correct them). (B) Cross connection control, as approved by the State. (C) Continuous disinfection ente ring the distribution system and a residual in the distribution system in accordance with criteria specified by the State. (D) Demonstration of maintenance of at least a 4-log removal or inactivation of viruses as provided for under § 141.403(b)(3). (E) Other equivalent enhancements to wa ter systems as approved by the State. (e) Return to routine mo nitoring requirements . Systems on quarterly m onitoring that experience any of the events in paragraphs (e)(1) through (e)(4) of this section must begin monthly monitoring the month following the event. The sy stem must continue monthly monitoring until it meets the reduced monitoring requiremen ts in paragraph (d) of this section.Document initiating EO 12866 review

264 (1) The system triggers a Level 2 assessment or two Level 1 assessments in a rolling 12-month period. (2) The system has an E. coli MCL violation. (3) The system has a coliform treatment technique violation. (4) The system has two subpart Y monitoring violations in a rolling 12-month period. (f) Additional routine monitoring . Systems collecting samples on a quarterly frequency must conduct additional routine monitoring the month following one or more total coliform-positive samples (with or without a Level 1 treatment tech nique trigger). Systems must collect at least three routine samples during the ne xt month, except that the State may waive this requirement if the conditions of paragraph (f)(1), (2), or (3) of this section are met. Systems may either collect samples at regular time intervals throughout th e month or may collect all required routine samples on a single day if samples are taken from di fferent sites. Systems must use the results of additional routine samples in coliform trea tment technique trigger calculations. (1) The State may waive the requirement to collect three routine samples the next month in which the system provides water to the public if the State, or an agent approved by the State, performs a site visit before the end of the next month in which the system provides water to the public. Although a sanitary survey need not be pe rformed, the site visit must be sufficiently detailed to allow the State to determine whet her additional monitoring and/or any corrective action is needed. The State cannot approve an employ ee of the system to perform this site visit, even if the employee is an agent approved by the State to perform sanitary surveys. (2) The State may waive the requirement to collect three routine samples the next month in which the system provides water to the public if the State has determined why the sample was total coliform-positive and has established that the system has corrected the problem or willDocument initiating EO 12866 review

265 correct the problem before the end of the next month in which the system serves water to the public. In this case, the State must document this decision to waive the following month's additional monitoring requirement in writing, have it approved and signed by the supervisor of the State official who recommends such a decisi on, and make this document available to the EPA and the public. The written documentation must describe the specific cause of the total coliform-positive sample and what action the system has taken and/or will take to correct this problem. (3) The State may not waive the requirement to collect three additional routine samples the next month in which the system provides water to th e public solely on the grounds that all repeat samples are total coliform-negative. If the Stat e determines that the system has corrected the contamination problem before the system take s the set of repeat sa mples required in § 141.858, and all repeat samples were total coliform-nega tive, the State may waive the requirement for additional routine mon itoring the next month.

§ 141.856 Routine monitoring requirements for subpart H public water systems serving 1,000 or fewer people. (a) General . (1) The provisions of this section appl y to subpart H public water systems serving 1,000 or fewer people. (2) Following any total coliform-positive sample taken under the provisions of this section, systems must comply with the re peat monitoring requirements and E. coli analytical requirements in § 141.858. (3) Once all monitoring required by this sec tion and § 141.858 for a calendar month has been completed, systems must determine whether any co liform treatment technique triggers specifiedDocument initiating EO 12866 review

266 in § 141.859 have been exceeded. If any trigger has been exceeded, systems must complete assessments as required by § 141.859. (4) Beginning [INSERT DATE THREE YEARS AFTE R PUBLICATION OF THE FINAL RULE] , all seasonal systems must demonstrate completion of a Stat e-approved start-up procedure, which may include a requirement for a startup sample prior to serving water to the public. (b) Routine monitoring freque ncy for total coliforms . Subpart H systems (including consecutive systems) must monitor monthly. Systems may not reduce monitoring. (c) Unfiltered subpart H systems. A subpart H system that does not practice filtration in compliance with subparts H, P, T, and W must colle ct at least one total coliform sample near the first service connection e ach day the turbidity level of the sour ce water, measured as specified in § 141.74(b)(2), exceeds 1 NTU. When one or more turbidity measurements in any day exceed 1 NTU, the system must collect this coliform sample within 24 hours of th e first exceedance, unless the State determines that the system, for l ogistical reasons outside the system's control, cannot have the sample analyzed within 30 hours of collection and identi fies an alternative sample collection schedule . Sample results from this coliform monitoring must be included in determining whether the coliform treatment t echnique trigger in § 141.859 has been exceeded.

§ 141.857 Routine monitoring requirements for public water systems serving more than 1,000 people. (a) General . (1) The provisions of this section apply to public water systems serving more than 1,000 persons.Document initiating EO 12866 review

267 (2) Following any total coliform-positive sample taken under the provisions of this section, systems must comply with the re peat monitoring requirements and E. coli analytical requirements in § 141.858. (3) Once all monitoring required by this sec tion and § 141.858 for a calendar month has been completed, systems must determine whether any co liform treatment technique triggers specified in § 141.859 have been exceeded. If any trigger has been exceeded, systems must complete assessments as required by § 141.859. (4) Beginning [INSERT DATE THREE YEARS AFTE R PUBLICATION OF THE FINAL RULE] , all seasonal systems must demonstrate completion of a Stat e-approved start-up procedure, which may include a requirement for a startup sample prior to serving water to the public. (b) Monitoring frequency for total coliforms. The monitoring frequency for total coliforms is based on the population served by the system, as follows: Total Coliform Monitoring Frequency for Public Water Systems Serving More Than 1,000 People Minimum number of Population served samples per month 1,001 to 2,500............................2 2,501 to 3,300............................3 3,301 to 4,100............................4 4,101 to 4,900............................5 4,901 to 5,800............................6 5,801 to 6,700............................7 6,701 to 7,600............................8 7,601 to 8,500............................9 8,501 to 12,900........................10 12,901 to 17,200......................15 17,201 to 21,500......................20 21,501 to 25,000......................25 25,001 to 33,000......................30 33,001 to 41,000......................40 41,001 to 50,000......................50Document initiating EO 12866 review

268 50,001 to 59,000......................60 59,001 to 70,000......................70 70,001 to 83,000......................80 83,001 to 96,000......................90 96,001 to 130,000..................100 130,001 to 220,000................120 220,001 to 320,000................150 320,001 to 450,000................180 450,001 to 600,000................210 600,001 to 780,000................240 780,001 to 970,000................270 970,001 to 1,230,000.............300 1,230,001 to 1,520,000..........330 1,520,001 to 1,850,000..........360 1,850,001 to 2,270,000..........390 2,270,001 to 3,020,000..........420 3,020,001 to 3,960,000..........450 3,960,001 or more..................480

(c) Unfiltered subpart H systems. A subpart H system that does not practice filtration in compliance with subparts H, P, T, and W must colle ct at least one total coliform sample near the first service connection e ach day the turbidity level of the sour ce water, measured as specified in § 141.74(b)(2), exceeds 1 NTU. When one or more turbidity measurements in any day exceed 1 NTU, the system must collect this coliform sample within 24 hours of the first exceedance, unless the State determines that the system, for l ogistical reasons outside the system's control, cannot have the sample analyzed within 30 hours of collection and identi fies an alternative sample collection schedule. Sample results from this coliform monitoring must be included in determining whether the coliform treatment t echnique trigger in § 141.859 has been exceeded. (d) Reduced monitoring. Systems may not reduce monitoring, except for non-community water systems using only ground water (and not ground water under the direct influence of surface water) serving 1,000 or fewer people in some m onths and more than 1,000 persons in other months. In months when more than 1,000 person s are served, the system s must monitor at theDocument initiating EO 12866 review

269 frequency specified in paragraph (a) of this se ction. In months when 1,000 or fewer people are served, the State may reduce the monitoring fr equency, in writing, to a frequency allowed under § 141.854 for a similarly situated system that alwa ys serves 1,000 or fewer people, taking into account the provisions in § 141.854(e) through (g).

§ 141.858 Repeat monitoring and E. coli requirements. (a) Repeat monitoring . (1) If a sample taken under §§ 141.854 though 141.857 is total coliformpositive, the system must collect a set of repeat samples within 24 hours of being notified of the positive result. The system must collect no fewer than three repeat samples for each total coliform-positive sample found. The State may extend the 24-hour limit on a case-by-case basis if the system has a logistical problem in collecting the repeat samples within 24 hours that is beyond its control. In the case of an extension, the State must sp ecify how much time the system has to collect the repeat samples. The State cannot waive the requirement for a system to collect repeat samples in paragraphs (a)( 1) through (a)(3) of this section. (2) The system must collect all repeat samples on the same day, except that the State may allow a system with a single service conne ction to collect the required se t of repeat samples over a threeday period or to collect a larger volume repeat sa mple(s) in one or more ample containers of any size, as long as the total volum e collected is at least 300 ml. (3) If one or more repeat samples in the set is total coliform-positive, the system must collect an additional set of repeat samples in the manner sp ecified in paragraphs (a)(1) through (a)(3) of this section. The additional samples must be co llected within 24 hours of being notified of the positive result, unless the State extends the limit as provided in paragraph (a)(1) of this section. The system must repeat this process until either total coliforms are not detected in one completeDocument initiating EO 12866 review

270 set of repeat samples or the system determines that a coliform treatment technique trigger has been exceeded and notifies the State. After a trigger identified in § 141.859 is reached, systems are not required to conduct more th an one round of repeat monitoring. (4) After a system collects a routine sample and befo re it learns the results of the analysis of that sample, if it collects another routine sample(s) from within five adjacent service connections of the initial sample, and th e initial sample, after an alysis, is found to contain total coliforms, then the system may count the subsequent sample(s) as a repeat sample instead of as a routine sample. (5) Results of all routine and repeat samples taken under §§ 141.854 through 141.858 not invalidated by the State must be used to determine whether a coliform treatment technique trigger § 141.859 has been exceeded. (b) Escherichia coli (E. coli) testing . (1) If any routine or repeat sample is total coliform-positive, the system must analyze that total colifor m-positive culture medium to determine if E. coli are present. If E. coli are present, the system must notify th e State by the end of the day when the system is notified of the test result, unless the sy stem is notified of the result after the State office is closed, in which case the syst em must notify the State before the end of the next business day. (2) The State has the discretion to allow a system, on a case-by-case basis, to forgo E. coli testing on a total coliform-positive sample if that system assumes that the total coliform-positive sample is E. coli -positive. Accordingly, the system must notify the State as specified in paragraph (b)(1) of this section and the pr ovisions of § 141.63(c) apply.

§ 141.859 Coliform treatment technique requiremen ts for protection against potential fecal
contamination.Document initiating EO 12866 review

271 (a) Treatment technique triggers. Systems must conduct assessments in accordance with paragraph (b) of this section af ter exceeding treatment technique triggers in paragraphs (a)(1) and (a)(2) of this section. (1) Level 1 treatment technique triggers. (i) For systems taking 40 or more samples pe r month, the system exceeds 5.0% total coliformpositive samples for the month. (ii) For systems taking fewer than 40 samples per month, the system has two or more total coliform-positive samples in the same month. (iii) The system fails to take every required repeat sample after any single total coliform-positive sample. (2) Level 2 treatment technique triggers. (i) An E. coli MCL violation, including failu re to collect repeat samp les within the required time following an E. coli- positive routine sample. (ii) A second Level 1 trigger as defined in para graph (a)(1) of this section, within a rolling 12- month period, unless the State has determined a likely reason that the initial samples that caused the Level 1 treatment technique trigger were to tal coliform-positive and has established that the system has corrected the problem. (iii) For systems with approved annual monitori ng, a Level 1 trigger in two consecutive years. (b) Requirements for assessments . (1) Systems must ensure that Level 1 and 2 assessments are conducted in order to identify the possible presence of sanitary def ects and defects in distribution system coliform monitoring prac tices. Level 2 assessments mu st be conducted by parties approved by the State.Document initiating EO 12866 review

272 (2) When conducting assessments, systems must ensure that the asse ssor evaluates minimum elements that include review and identification of inadequacies in sample sites; sampling protocol; sample processing; atypical events that could affect dist ributed water quality or indicate that distributed water quality was impaired; ch anges in distribution system maintenance and operation that could affect dist ributed water quality (includi ng water storage); source and treatment considerations that bear on distributed water quality, where appropriate (e.g. small ground water systems); and existing water quality monitoring data. The State may tailor specific assessment elements to the size and type of th e system. Systems may tailor their assessment activities based on the characteristics of the di stribution system (consistent with any State directives). (3) Level 1 Assessments. A system must conduc t a Level 1 assessment consistent with State requirements if the system exceeds one of the trea tment technique triggers in paragraph (a)(1) of this section. (i) The system must complete a Level 1 assessment as soon as practical after failure to take a repeat sample or after notifica tion of monitoring results. In th e completed assessment form, the system must identify sanitary defects detecte d, corrective actions completed, and a timetable for any corrective actions not already completed. The assessment form may also note that no sanitary defects were identified. The system must submit the completed Level 1 assessment form to the State within 30 days after de termination of exceeding the trigger. (ii) If the State reviews the completed Level 1 assessment and determines that the assessment is not sufficient, the State must consult with the sy stem. If necessary afte r consultation, the system must submit a revised assessment form to the St ate on an agreed-upon schedule not to exceed 30 days from the date of the consultation. Upon co mpletion and submission of the assessment formDocument initiating EO 12866 review

273 by the system, the State must determine if the sy stem has identified a likely cause for the Level 1 trigger and, if so, establish that the system ha s corrected the problem, or has included a schedule acceptable to the State for correcting the problem. (4) Level 2 Assessments. A system must ensure that a Level 2 assessment consistent with State requirements is conducted if the system exceeds one of the treatment technique triggers in paragraph (a)(2) of this section. The State may direct expedited actions or additional actions in the case of an E. coli MCL violation. (i) The system must ensure that a Level 2 asse ssment is completed by th e State or by a party approved by the State as soon as practical afte r failure to take a repeat sample or after notification of monitoring results. The syst em must submit a completed Level 2 assessment form to the State within 30 days after the determination of exceed ing the trigger. The assessment form must describe sanitary defects detected, corrective actions completed, and a timetable for any corrective actions not already completed. The assessment form may also note that no sanitary defects were identified. (ii) The system may conduct Level 2 assessments if the system has staff or management with the certification or qualifications sp ecified by the State unless otherw ise directed by the State. (iii) If the State reviews the completed Level 2 assessment and determines that the assessment is insufficient, the State must consult with the syst em. If necessary after consultation, the system must submit a revised assessment form to the St ate on an agreed-upon schedule not to exceed 30 days. Upon completion and submission of the as sessment form by the system, the State must determine if the system has identified a likely cause for the Level 2 trigger and determine whether the system has corrected the problem, or has included a schedule acceptable to the State for correcting the problem.Document initiating EO 12866 review

274 (c) Corrective Action . Systems must correct sanitary de fects found through either Level 1 or 2 assessments conducted under paragraph (b) of this section. For correctio ns not completed by the time of submission of the assessment form, the syst em must complete the corrective action(s) in compliance with a schedule determined by the Stat e in consultation with the system. The system must notify the State when each schedule d corrective action is completed. (d) Consultation. At any time during the assessment or corr ective action phase, either the water system or the State may request a consultation w ith the other party to de termine the appropriate actions to be taken. The system may consult with the State on all relevant information that may impact on its ability to comply with a requirement of this subpart, including the method of accomplishment, an appropriate timeframe, and other relevant information.

§ 141.860 Violations. (a) E. coli MCL Violation . A system is in violation of the MCL for E. coli when any of the conditions identified in paragraphs (a)(1) th rough (a)(4) of this section occur. (1) The system has an E. coli -positive repeat sample following a total coliform-positive routine sample. (2) The system has a total coliform-positive repeat sample following an E. coli -positive routine sample. (3) The system fails to take all required repeat samples following an E. coli -positive routine sample. (4) The system fails to test for E. coli when any repeat sample tests positive for total coliform. (b) Treatment technique violation . A treatment technique viol ation occurs when a system exceeds a treatment technique trigger specified in § 141.859(a) and then fails to conduct the required assessment or corrective actions within the timeframe specified in § 141.859(b) and (c). (c) Monitoring violations . Failure to take every required rout ine or additional routine sample inDocument initiating EO 12866 review

275 a compliance period is a routine monitori ng violation. Failure to analyze for E. coli following a total coliform routine sample is a monitoring violation.
(d) Reporting violations . (1) Failure to subm it a monitoring report or completed assessment form after a system properly conducts monitoring or assessment is a reporting violation.
(2) Failure to notify the State following an E. coli -positive sample as required by § 141.858(b)(1) is a reporting violation.

§ 141.861 Reporting an d recordkeeping. (a) Reporting . (1) A system that has violated the E. coli MCL must report the violation to the State no later than the en d of the next business day after it le arns of the violation, and notify the public in accordance with subpart Q. A system mu st notify the State no late r than the end of the next business day afte r it learns of an E. coli -positive sample. (2) A system that has violated the treatment technique for total coliforms in § 141.859 must report the violation to the State no later than the end of the next bus iness day after it learns of the violation, and notify the public in accordance with subpart Q. Th e system must notify the State in accordance with § 141.859(c) when each sche duled corrective action is completed for corrections not completed by the time of submission of the assessment form. (3) A system that has failed to comply with a coliform monitoring requirement must report the monitoring violation to the State within 10 days after the system discovers the violation, and notify the public in accordance with subpart Q. (b) Recordkeeping . The system must maintain any assessment form, regardless of who conducts the assessment, and documentati on of corrective actions comp leted as a result of those assessments, or other available summary documen tation of the sanitary defects and correctiveDocument initiating EO 12866 review

276 actions taken under § 141.858 for State review. This record must be maintained by the system for a period not less than five years after comp letion of the assessment or corrective action.

PART 142 – NATIONAL PRIMARY DR INKING WATER REGULATIONS IMPLEMENTATION

21. The authority citation for part 142 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.

22. Section 142.14 is amended by revising paragra ph (a)(1)(iii) and adding a new paragraph (a)(10) to read as follows: § 142.14 Records kept by States. (a) *** (1) *** (iii) The analytical results, set forth in a fo rm that makes possible comparison with the limits specified in §§ 141.63, 141.71, and 141.72 and with the limits specified in subpart Y of this chapter.
***** (10) Records of each of the following decisions made pursuant to the provisions of subpart Y of part 141 must be made in writing and retained by the State. (i) Records of the following decisions or act ivities must be retained for five years.Document initiating EO 12866 review

277 (A) Sections 141.858(a), 141.853(b)(2), 141.856(c), and 141.857(c) - Any decision to waive the 24-hour time limit for collecting repeat samples af ter a total coliform-positive routine sample, or to extend the 24-hour limit for collection of samp les following invalidation, or for an unfiltered subpart H system to collect a total coliform sample following a turbidity measurement exceeding
1 NTU. (B) Sections 141.854(j) and 141.855(f)—Any decisi on to allow a system to waive the requirement for three routine samples the month following a total coliform-positive sample. The record of the waiver decision must contai n all the items listed in those sections. (C) Section 141.853(c) —Any decisi on to invalidate a total co liform-positive sample. If the decision to invalidate a total coliform-positive sample as provided in § 141.853(c)(1) is made, the record of the decision must contai n all the items listed in that section. (D) – Section 141.859 – Completed and approved subpa rt Y assessments, including reports from the system that corrective action has been completed as required by § 141.861(a)(2). (ii) Records of each of the following decisions mu st be retained in such a manner so that each system’s current status may be determined: (A) Section 141.855(d) - Any decision to reduce th e total coliform mon itoring frequency for a community water system serving 1,000 or fewer people to less than once per month, as provided in § 141.855(d), including what the reduced mon itoring frequency is. A copy of the reduced monitoring frequency must be provided to the system. (B) Section 141.854(e) - Any decision to reduce th e total coliform monitoring frequency for a non-community water system using only ground wa ter and serving 1,000 or fewer people to less than once per quarter, as provided in § 141.854( e), including what the reduced monitoring frequency is. A copy of the reduced monitoring frequency must be provided to the system.Document initiating EO 12866 review

278 (C) Section 141.857(d) - Any decision to reduce th e total coliform monitoring frequency for a non-community water system using only ground water and serving more than 1,000 persons during any month the system serves 1,000 or fe wer people, as provided in § 141.857(d). A copy of the reduced monitoring frequency must be provided to the system. (D) Section 141.858(b)(2) - Any decision to allow a system to forgo E. coli testing of a total coliform-positive sample if that system assumes that the total coliform-positive sample is E. colipositive.

23. Section 142.15 is amended by adding paragr aph (c)(3) to read as follows:

§ 142.15 Reports by States. ***** (c) *** (3) Total coliforms under subpart Y. A list of systems that the State is allowing to monitor less frequently than once per month for community wa ter systems or less freq uently than once per quarter for non-community water systems as provided in §§ 141.855 and 141.854, respectively, including the applicable date of the redu ced monitoring requirement for each system.
***** 24. Section 142.16 is amended by adding a new paragraph (q) to read as follows:

§ 142.16 Special primacy requirements.
*****Document initiating EO 12866 review

279 (q) Requirements for States to adopt 40 CFR part 141 subpart Y – Revised Total Coliform Rule

. In addition to the general primacy requireme nts elsewhere in this part, including the requirements that State regulations be at least as stringent as fede ral requirements, an application for approval of a State program revision that adop ts 40 CFR part 141 subpart Y, must contain the information specified in this paragraph (q). (1) In their application to EP A for approval to implement the federal requirements, the primacy application must indicate what baseline and reduced monitori ng provisions of 40 CFR part 141 subpart Y the State will adopt and must describe how they will implement 40 CFR part 141 subpart Y in these areas so that EPA can be assured that implementation plans meet the minimum requirements of the rule. (2) The State’s application for primacy for subpa rt Y must include a written description for each provision included in paragr aphs (q)(2)(i) through (v iii) of this section. (i) Sample Siting Plans - The frequency and pro cess used to review a nd revise sample siting plans in accordance with 40 CFR part 141 subpart Y to determine adequacy. (ii) Reduced Monitoring Criteria – An indicat ion of whether the Stat e will adopt the reduced monitoring provisions of 40 CFR pa rt 141 subpart Y. If the Stat e adopts the reduced monitoring provisions, it must describe the specific types or categories of water systems that will be covered by reduced monitoring and whether the State will use all or a reduced set of the optional criteria. For each of the reduced monitoring criteria, both mandatory and opti onal, the State must describe how the criteria will be evaluated to determine when systems qualify. (iii) Assessments and Corrective Actions – Th e process for implementing the new assessment and corrective action phase of the rule, including the elements in paragraphs (q)(2)(iii)(A) through (D) of this section.Document initiating EO 12866 review

280 (A) Elements of Level 1 and Level 2 assessments. This must include an explanation of how the State will ensure that Level 2 a ssessments provide a more detailed examination of the system (including the system’s monitoring and operatio nal practices) than do Level 1 assessments through the use of more compre hensive investigation and revi ew of available information, additional internal and external reso urces, and other relevant practices. (B) Examples of sanitary defects. (C) Examples of assessment forms or formats. (D) Methods that systems may us e to consult with the State on appropriate corrective actions. (iv) Invalidation of routine a nd repeat samples collected under 40 CFR part 141 subpart Y – The criteria and process for i nvalidating total coliform and E. coli- positive samples under 40 CFR part 141 subpart Y. This description must in clude criteria to determine if a sample was improperly processed by the laboratory, reflects a domestic or other non-distribution system plumbing problem or reflects circumstances or cond itions that do not reflect water quality in the distribution system. (v) Approval of individuals allowed to conduct Level 2 assessments under 40 CFR part 141 subpart Y – The criteria and pr ocess for approval of individua ls allowed to conduct Level 2 assessments under 40 CFR part 141 subpart Y. (vi) Special monitoring evaluation – The pr ocedure for performing special monitoring evaluations during sanitary su rveys for ground water systems se rving 1,000 or fewer people to determine whether systems are on an appropriate monitoring schedule. (vii) Seasonal systems – How the State will identify seasonal systems, how the State will determine when systems on less than monthly monitoring must monitor, and what start-up provisions seasonal system must meet under 40 CFR part 141 subpart Y.Document initiating EO 12866 review

281 (viii) Additional criteria for re duced monitoring – How the State will require systems on reduced monitoring to demonstrate: (A) Continuous disinfection ente ring the distribution system and a residual in the distribution system. (B) Cross connection control. (C) Other enhancements to water system barriers. (ix) Procedures for seasonal systems to star t up operations at the beginning of each season.

25. Section 142.63 paragraph (b) is re vised to read as follows:

§ 142.63 Variances and exemptions from th e maximum contaminan t level for total
coliforms. ***** (b) EPA has stayed this secti on as it relates to the total coli form MCL of § 141.63(a) for systems that demonstrate to the State that the violation of the total colifo rm MCL is due to a persistent growth of total coliforms in the distributi on system rather than fecal or pathogenic contamination, a treatment lapse or deficiency, or a problem in the operation or maintenance of the distribution system. This stay is applicable until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE] , at which time the total coliform MCL is no longer applicable.