65574 Federal Register / Vol. 71, No. 216 / Wednesday, November 8, 2006 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9, 141 and 142 

[EPA–HQ–OW–2002–0061; FRL–8231–9] 

RIN 2040–AA97 

National Primary Drinking Water 

Regulations: Ground Water Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency is promulgating a National 

Primary Drinking Water Regulation, the 

Ground Water Rule, to provide for 

increased protection against microbial 

pathogens in public water systems that 

use ground water sources. This final 

rule is in accordance with the Safe 

Drinking Water Act as amended, which 

requires the Environmental Protection 

Agency to promulgate National Primary 

Drinking Water Regulations requiring 

disinfection as a treatment technique for 

all public water systems, including 

surface water systems and, as necessary, 

ground water systems. 

The Ground Water Rule establishes a 

risk-targeted approach to target ground 

water systems that are susceptible to 

fecal contamination, instead of requiring 

disinfection for all ground water 

systems. The occurrence of fecal 

indicators in a drinking water supply is 

an indication of the potential presence 

of microbial pathogens that may pose a 

threat to public health. This rule 

requires ground water systems that are 

at risk of fecal contamination to take 

corrective action to reduce cases of 

illnesses and deaths due to exposure to 

microbial pathogens. 

DATES: This final rule is effective on 

January 8, 2007. The incorporation by 

reference of certain publications listed 

in this rule is approved by the Director 

of the Federal Register as of January 8, 

2007. For judicial review purposes, this 

final rule is promulgated as of 1 p.m. 

Eastern time on November 22, 2006, as 

provided in 40 Code of Federal 

Regulations (CFR) 23.7. The compliance 

date, unless otherwise noted, for the 

rule requirements is December 1, 2009. 

ADDRESSES: The Environmental 

Protection Agency (EPA) has established 

a docket for this action under Docket ID 

No. EPA–HQ–OW–2002–0061. All 

documents in the docket are listed on 

the http://www.regulations.gov Web 

site. Although listed in the index, some 

information is not publicly available, 

e.g., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the Water Docket. 

Note: The EPA Docket Center suffered 

damage due to flooding during the last week 

of June 2006. The Docket Center is 

continuing to operate. However, during the 

cleanup, there will be temporary changes to 

Docket Center telephone numbers, addresses, 

and hours of operation for people who wish 

to visit the Public Reading Room to view 

documents. Consult EPA’s Federal Register 

notice at 71 FR 54815 (September 19, 2006) 

or the EPA Web site at http://www.epa.gov/ 

epahome/dockets.htm for current 

information on docket status, locations and 

telephone numbers. 

FOR FURTHER INFORMATION CONTACT: 

Crystal Rodgers, Standards and Risk 

Management Division, Office of Ground 

Water and Drinking Water (MC–4607M), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460; telephone number: (202) 

564–5275; e-mail address: 

rodgers.crystal@epa.gov. For general 

information, contact the Safe Drinking 

Water Hotline, telephone number: (800) 

426–4791. The Safe Drinking Water 

Hotline is open Monday through Friday, 

excluding legal holidays, from 10 a.m. 

to 4 p.m. Eastern time. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

Entities potentially regulated by the 

Ground Water Rule (GWR) are public 

water systems (PWSs) using ground 

water as a drinking water source. 

Regulated categories and entities 

include the following: 

Category Examples of 

regulated entities 

Industry ..................... Public ground water 

systems. 

State, Local, Tribal or 

Federal Governments.

Public ground water 

systems. 

This table is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

regulated by this action. This table lists 

the types of entities that EPA is now 

aware could potentially be regulated by 

this action. Other types of entities not 

listed in the table could also be 

regulated. To determine whether your 

facility is regulated by this action, you 

should carefully examine the 

applicability criteria found in § 141.400 

of this rule. If you have questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed in the preceding FOR FURTHER

INFORMATION CONTACT section. 

Abbreviations Used in This Document 

AIDS Acquired Immune Deficiency 

Syndrome 

AGI Acute Gastrointestinal Illness 

AWWA American Water Works Association 

ASDWA Association of State Drinking 

Water Administrators 

AWWARF American Water Works 

Association Research Foundation 

AWWSCo American Water Works Service 

Company 

BGLB Brilliant green lactose bile broth 

BGM Buffalo Green Monkey 

BMPs Best Management Practices 

CAFO Concentrated Animal Feeding 

Operation 

CBI Confidential Business Information 

CCR Consumer Confidence Report 

CDBG Community Development Block 

Grant 

CDC Centers for Disease Control and 

Prevention 

CFR Code of Federal Regulation 

COI Cost of Illness 

CT The Residual Concentration of 

Disinfectant (mg/L) Multiplied by the 

Contact Time (in minutes) 

CWS Community Water System 

CWSS Community Water System Survey 

DBPs Disinfection Byproducts 

DWSRF Drinking Water State Revolving 

Fund 

EA Economic Analysis 

EPA United States Environmental 

Protection Agency 

FR Federal Register 

GAO United States Government 

Accountability Office 

GI Gastrointestinal 

GWUDI Ground Water Under the Direct 

Influence of Surface Water 

GWR Ground Water Rule 

GWS Ground Water System 

HAV Hepatitis A Virus 

HRRCA Health Risk Reduction and Cost 

Analysis 

HSA Hydrogeologic Sensitivity Assessment 

ICR Information Collection Request 

IESWTR Interim Enhanced Surface Water 

Treatment Rule 

IRFA Initial Regulatory Flexibility Analysis 

LTB Lauryl tryptose broth 

m Meters 

mL Milliliters 

MCL Maximum Contaminant Level 

mg/L Milligrams per Liter 

MPNIU Most Probable Number of Infectious 

Units 

MRDL Maximum Residual Disinfectant 

Level 

MWCO Molecular Weight Cut-Off 

NCWS Non-Community Water System 

NDWAC National Drinking Water Advisory 

Council 

NF Nanofiltration 

NODA Notice of Data Availability 

NTNCWS Non-Transient Non-Community 

Water System 

NTTAA National Technology Transfer and 

Advancement Act of 1995 

NPDWR National Primary Drinking Water 

Regulation 

O&M Operation and Maintenance 


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OMB Office of Management and Budget 

P–A Presence-absence 

PCR Polymerase Chain Reaction 

PNR Public Notification Rule 

PWS Public Water System 

RFA Regulatory Flexibility Act 

RIA Regulatory Impact Analysis 

RO Reverse Osmosis 

RT–PCR Reverse Transcriptase—

Polymerase Chain Reaction 

SAB Science Advisory Board 

SBREFA Small Business Regulatory 

Enforcement Fairness Act 

SD Standard Deviation 

SDWA Safe Drinking Water Act 

SDWIS Safe Drinking Water Information 

System 

SEFA Small Entity Flexibility Analysis 

Stage 2 DBPR Stage 2 Disinfectants and 

Disinfection Byproducts Rule 

SWAP Source Water Assessment Program 

SWTR Surface Water Treatment Rule 

TCR Total Coliform Rule 

TNCWS Transient Non-Community Water 

System 

UIC Underground Injection Control 

UMRA Unfunded Mandates Reform Act 

US United States 

USGS United States Geological Survey 

UV Ultraviolet Radiation 

VSL Value of Statistical Life 

WHO World Health Organization 

WTP Willingness To Pay 

Table of Contents 

I. General Information 

II. Summary 

A. Why Is EPA Promulgating the GWR? 

B. What Does the GWR Require? 

1. Sanitary Surveys 

2. Source Water Monitoring 

3. Treatment Technique Requirements 

4. Compliance Monitoring 

C. How Has the Final Rule Changed From 

What EPA Proposed? 

D. Does This Regulation Apply to My 

Water System? 

III. Background 

A. What Is the Statutory Authority for the 

GWR? 

B. What Is the Regulatory History of the 

GWR and How Were Stakeholders 

Involved? 

C. What Public Health Concerns Does the 

GWR Address? 

1. Introduction 

2. Waterborne Disease Outbreaks in 

Ground Water Systems 

3. Microbial Contamination in Public 

Ground Water Systems 

4. Potential Risk Implications From 

Occurrence Data 

IV. Discussion of GWR Requirements 

A. Sanitary Surveys 

1. What Are the Requirements of This 

Rule? 

2. What Is EPA’s Rationale for the GWR 

Sanitary Survey Requirements? 

3. What Were the Key Issues Raised by 

Commenters on the Proposed GWR 

Sanitary Survey Requirements? 

B. Source Water Monitoring 

1. What Are the Requirements of This 

Rule? 

2. What Is EPA’s Rationale for the GWR 

Source Water Monitoring Requirements? 

3. What Were the Key Issues Raised by 

Commenters on the Proposed GWR 

Source Water Monitoring Requirements? 

C. Corrective Action Treatment Techniques 

for Systems With Significant 

Deficiencies or Source Water Fecal 

Contamination 

1. What Are the Requirements of This 

Rule? 

2. What Is EPA’s Rationale for the GWR 

Treatment Technique Requirements? 

3. What Were the Key Issues Raised by 

Commenters on the Proposed GWR 

Treatment Technique Requirements? 

D. Providing Notification and Information 

to the Public 

1. What Are the Requirements of This 

Rule? 

2. What Is EPA’s Rationale for the Public 

Notice Requirements? 

3. What Were the Key Issues Raised by 

Commenters on the Proposed GWR 

Public Notification Requirements? 

E. What Are the Reporting and 

Recordkeeping Requirements for 

Systems? 

1. Reporting Requirements 

2. Recordkeeping Requirements 

3. What Were the Key Issues Raised by 

Commenters on the Proposed GWR 

Reporting and Recordkeeping 

Requirements for Systems? 

F. What Are the Special Primacy, 

Reporting, and Recordkeeping 

Requirements for States? 

1. Primacy Requirements 

2. Reporting Requirements 

3. Recordkeeping Requirements 

4. What Were the Key Issues Raised by 

Commenters on the Proposed GWR 

Special Primacy, Reporting, and 

Recordkeeping Requirements for States? 

G. Variances and Exemptions 

1. Variances 

2. Exemptions 

V. Explanation of Extent of GWR 

A. Mixed Systems 

B. Cross-Connection Control 

VI. Implementation 

VII. Economic Analysis (Health Risk 

Reduction and Cost Analysis) 

A. How Has the Final Rule Alternative 

Changed From the Proposed Rule 

Alternative? 

B. Analyses That Support This Rule 

1. Occurrence Analysis 

2. Risk Analyses 

C. What Are the Benefits of the GWR? 

1. Calculation of Baseline Health Risk 

2. Calculation of Avoided Illnesses and 

Deaths 

3. Derivation of Quantified Benefits 

4. Nonquantifiable Benefits 

5. How Have the Benefits Changed Since 

the Proposal? 

D. What Are the Costs of the GWR? 

1. Summary of Quantified Costs 

2. Derivation of Quantified Costs 

3. Nonquantifiable Costs 

4. How Have the Costs Changed Since the 

Proposal? 

E. What Is the Potential Impact of the GWR 

on Households? 

F. What Are the Incremental Costs and 

Benefits of the GWR? 

G. Are There Any Benefits From 

Simultaneous Reduction of Co-Occurring 

Contaminants? 

H. Is There Any Increase in Risk From 

Other Contaminants? 

I. What Are the Effects of the Contaminant 

on the General Population and Groups 

Within the General Population That Are 

Identified as Likely To Be at Greater Risk 

of Adverse Health Effects? 

1. Risk of Acute Viral Illness to Children 

and Pregnant Women 

2. Risk of Viral Illness to the Elderly and 

Immunocompromised 

J. What Are the Uncertainties in the Risk, 

Benefit, and Cost Estimates for the GWR? 

1. The Baseline Numbers of Ground Water 

Systems, Populations Served, and 

Associated Disinfection Practice 

2. The Numbers of Wells Designated as 

More Versus Less Vulnerable 

3. The Baseline Occurrence of Viruses and 

E. coli in Ground Water Wells 

4. For the Sanitary Survey Provisions, the 

Percentage of Systems Identified as 

Having Significant Deficiencies, the 

Percentage of These Deficiencies That 

Are Corrected, and State Costs for 

Conducting Surveys 

5. The Predicted Rates at Which Virally 

Contaminated (and Non-Contaminated) 

Wells Will Be Required To Take Action 

After Finding E. coli Ground Water 

Sources 

6. The Infectivity of Echovirus and 

Rotavirus Used to Represent Viruses 

That Occur in Ground Water 

7. The Costs of Illnesses Due to Ingestion 

of Contaminated Ground Water 

8. The Costs of Taking Action After 

Finding E. coli in Ground Water Sources 

9. Nonquantifiable Benefits 

10. Optional Assessment Source Water 

Monitoring 

11. Corrective Actions and Significant 

Deficiencies 

12. Uncertainty Summary 

K. What Is the Benefit/Cost Determination 

for the GWR? 

L. What Were Some of the Major 

Comments Received on the Economic 

Analysis and What Are EPA’s 

Responses? 

1. Costs 

2. Benefits 

3. Risk Management 

VIII. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

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 Coordination With Indian Tribal 

Governments 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

1. Energy Supply 

2. Energy Distribution 

3. Energy Use 


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I. National Technology Transfer and 

Advancement Act 

J. Executive Order 12898: Federal Actions 

to Address Environmental Justice in 

Minority Populations and Low-Income 

Populations 

K. Congressional Review Act 

L. Analysis of the Likely Effect of 

Compliance With the GWR on the 

Technical, Financial, and Managerial 

Capacity of Public Water Systems 

IX. Consultation With Science Advisory 

Board, National Drinking Water 

Advisory Council, and the Secretary of 

Health and Human Services; and Peer 

Review 

X. References 

II. Summary 

This section includes a discussion of 

the purpose of the Ground Water Rule 

(GWR) and a summary of the GWR 

requirements. 

A. Why Is EPA Promulgating the GWR? 

EPA is promulgating the GWR to 

provide for increased protection against 

microbial pathogens, specifically viral 

and bacterial pathogens, in public water 

systems (PWSs) that use ground water 

sources. EPA is particularly concerned 

about ground water systems (GWSs) that 

are susceptible to fecal contamination 

because these systems may be at risk of 

supplying water that contains harmful 

microbial pathogens. Viral pathogens 

found in GWSs may include enteric 

viruses such as Echovirus, Coxsackie 

viruses, Hepatitis A and E, Rotavirus 

and Noroviruses (i.e., Norwalk-like 

viruses) and enteric bacterial pathogens 

such as Escherichia coli (most E. coli is 

harmless but a few species are 

pathogenic, including E. coli O157:H7), 

Salmonella species, Shigella species, 

and Vibrio cholerae. Ingestion of these 

pathogens can cause gastroenteritis or, 

in certain cases, serious illnesses such 

as meningitis, hepatitis, or myocarditis. 

Health implications in sensitive 

subpopulations (e.g., children, elderly, 

immuno-compromised) may be severe 

(e.g., hemolytic uremic syndrome) and 

may cause death. 

One goal of the GWR is to identify 

and target GWSs that are susceptible to 

fecal contamination because such 

contamination is the likely source of 

viral and bacterial pathogens in 

drinking water supplies. Ground water 

is fecally contaminated when fecal 

indicators (e.g., E. coli, enterococci, or 

coliphage) are present. While fecal 

indicators typically are not harmful 

when ingested, their presence 

demonstrates that there is a pathway for 

pathogenic viruses and bacteria to enter 

ground water sources. Another key 

objective of the rule is to protect public 

health by requiring these higher risk 

GWSs to monitor and, when necessary, 

take corrective action. Corrective action 

can include correcting all significant 

deficiencies; providing an alternate 

source of water; eliminating the source 

of contamination; or providing 

treatment that reliably achieves at least 

99.99 percent (4-log) treatment of 

viruses (using inactivation, removal, or 

a State-approved combination of 4-log 

virus inactivation and removal) for each 

contaminated ground water source. 

Each of these corrective actions is 

intended to remove all or nearly all fecal 

contamination, including both viral and 

bacterial pathogens. This rule 

implements section 1412(b)(8) of the 

1996 Safe Drinking Water Act (SDWA) 

Amendments to promulgate a rule 

requiring GWSs to disinfect ‘‘as 

necessary.’’ The risk-targeted approach 

in this rule is a critical distinction from 

the approach outlined in the 1986 

SDWA, which would have required all 

PWSs using surface water or ground 

water to disinfect. Because there are so 

many GWSs (approximately 147,000) in 

the United States, such a requirement 

would have been a great challenge for 

systems and States to implement. 

This rule is necessary to protect 

public health because current regulatory 

provisions for GWSs (for example, 

sanitary survey requirements in the 

Total Coliform Rule (TCR) (54 FR 27544, 

June 29, 1989) (USEPA, 1989a)) do not 

adequately address fecal contamination 

at the ground water source. In fact, no 

Federal regulation exists that requires 

either monitoring of ground water 

sources or corrective action upon 

finding fecal contamination or 

identifying a significant deficiency 

during a sanitary survey. In addition, 

the U.S. Government Accountability 

Office (GAO) 1993 report (USGAO, 

1993) found that many sanitary surveys 

did not evaluate one or more of the 

components that EPA recommended be 

evaluated, and that efforts to ensure 

correction were often limited. Also, 

GAO found that follow-up on major 

problems was often lacking. Moreover, 

the report found that problems 

associated with system infrastructure 

identified during sanitary surveys 

frequently remain uncorrected. The 

GWR provides much needed public 

health protection by requiring systems 

that do not treat their ground water 

sources to monitor their ground water 

source and to take corrective actions 

when fecal contamination or a 

significant deficiency is found. 

In addition, EPA has evaluated data 

on outbreaks and the occurrence of 

waterborne viral and bacterial 

pathogens and indicators of fecal 

contamination in ground water 

supplying PWS wells. These data 

indicate that there is a subset of GWSs 

that are susceptible to fecal 

contamination; therefore, EPA believes 

that risk management strategies are 

needed to protect public health. 

Specifically, the Centers for Disease 

Control and Prevention (CDC) reports 

that between 1991 (the year in which 

the TCR became effective) and 2000, 

GWSs were associated with 68 

waterborne disease outbreaks that 

caused 10,926 illnesses (Moore et al. 

(1993); Kramer et al. (1996); Levy et al. 

(1998); Barwick et al. (2000); and Lee et 

al. (2002)). These outbreaks accounted 

for 51 percent of all waterborne disease 

outbreaks in the United States during 

that time period. The major deficiencies 

identified by the CDC report as the 

likely cause of the outbreaks were 

source water contamination and 

inadequate treatment (or treatment 

failures); see Section III.C.2 for a 

summary of these outbreak data. Studies 

of viral and bacterial pathogens and/or 

fecal indicator occurrence in ground 

waters that supply PWSs show that 

dozens of the public ground water wells 

sampled had fecal indicator or viral 

presence in their wells. See Section 

III.C.3 of this preamble for a summary 

of occurrence studies. Based on these 

outbreak and occurrence data, along 

with concern about lack of monitoring 

and follow-up actions for GWSs, EPA 

has concluded that GWSs need to 

implement targeted, risk management 

strategies to protect public health from 

bacterial and viral pathogens in fecally 

contaminated ground water sources. 

To provide a flexible, risk-targeted 

approach to achieve public health 

protection, this rule builds on existing 

State programs—some that emphasize 

the importance of disinfection and 

others that emphasize assessments and 

technical assistance—to identify and 

target susceptible GWSs. In addition, 

the GWR establishes treatment 

technique requirements, which provide 

public GWSs with multiple options to 

correct source water fecal contamination 

and significant deficiencies that present 

a public health risk. Furthermore, this 

rule establishes compliance monitoring 

requirements to ensure that treatment 

effectiveness is maintained. 

B. What Does the GWR Require? 

The GWR establishes a risk-targeted 

approach to identify GWSs susceptible 

to fecal contamination and requires 

corrective action to correct significant 

deficiencies and source water fecal 

contamination in public GWSs. A 

central objective of the GWR is to 

identify the subset of ground water 

sources that are at higher risk of fecal 

contamination among the large number 


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of existing GWSs (approximately 

147,000), and then further target those 

systems that must take corrective action 

to protect public health. This risktargeting strategy includes the 

following: 

• Regular GWS sanitary surveys to 

check for significant deficiencies in 

eight key operational areas; 

• A flexible program for identifying 

higher risk systems through existing 

TCR monitoring and State 

determinations; and 

• Ground water source monitoring to 

detect fecal contamination at targeted 

GWSs that do not provide 4-log 

treatment of viruses. 

Measures to protect public health 

include the following: 

• Treatment technique requirements 

to address sanitary survey significant 

deficiencies and fecal contamination in 

ground water; and 

• Compliance monitoring to ensure 

that 4-log treatment of viruses is 

maintained where it is used to comply 

with this rule. 

To meet the treatment technique 

requirements of this rule, GWSs with a 

significant deficiency or evidence of 

source water fecal contamination, 

following consultation with their 

primacy agency (herein referred to as 

‘‘the State’’), must implement one or 

more of the following corrective action 

options: Correct all significant 

deficiencies; provide an alternate source 

of water; eliminate the source of 

contamination; or provide treatment 

that reliably achieves at least 99.99 

percent (4-log) treatment of viruses 

(using inactivation, removal, or a Stateapproved combination of 4-log virus 

inactivation and removal) for each 

ground water source. Each of these 

corrective actions is intended to remove 

all or nearly all fecal contamination, 

including both viral and bacterial 

pathogens. In addition, the GWS must 

inform its customers of any uncorrected 

significant deficiencies or fecal 

indicator-positive ground water source 

samples. 

The following sections provide more 

detailed information on the provisions 

of the GWR. 

1. Sanitary Surveys 

Sanitary surveys are an important tool 

for identifying potential vulnerabilities 

to fecal contamination at GWSs. The 

final GWR includes Federal sanitary 

survey requirements for all GWSs for 

the first time. This rule requires States, 

as a condition for primacy, to perform 

regular comprehensive sanitary surveys 

of the following eight critical 

components to the extent that they 

apply to the individual water system 

being surveyed: (1) Source; (2) 

treatment; (3) distribution system; (4) 

finished water storage; (5) pumps, pump 

facilities, and controls; (6) monitoring, 

reporting, and data verification; (7) 

system management and operation; and 

(8) operator compliance with State 

requirements. This rule includes 

conditions of primacy in 40 CFR part 

142 under which States will have until 

December 31, 2012 to complete the 

initial sanitary survey cycle for 

community water systems (CWSs), 

except those that meet performance 

criteria, and until December 31, 2014 to 

complete the initial sanitary survey 

cycle for all non-community water 

system (NCWSs) and CWSs that meet 

performance criteria (refer to Section 

IV.A.1 for crtieria). Following the initial 

sanitary survey cycle, States must 

conduct these surveys every three years 

for CWSs (defined in § 141.2), and every 

five years for all NCWSs and CWSs that 

meet certain performance criteria as 

discussed in Section IV.A.1. 

If a significant deficiency is identified 

as a result of a sanitary survey, the 

system must take corrective action. If 

the system does not complete corrective 

action within 120 days of receiving 

notification from the State, or is not in 

compliance with a State-approved 

corrective action plan and schedule, the 

system will be in violation of the 

treatment technique requirements of 

this rule. 

The final GWR sanitary survey 

provision provides comprehensive and 

effective public health protection by 

specifying the scope and frequency of 

sanitary surveys and by requiring 

corrective action for systems with 

significant deficiencies. 

2. Source Water Monitoring 

This rule requires triggered source 

water monitoring and provides States 

with the option to require assessment 

source water monitoring. Source water 

monitoring is an effective tool to target 

at-risk systems that must take corrective 

action to protect public health. 

Indications of risk may come from total 

coliform monitoring, hydrogeologic 

sensitivity analyses, or other systemspecific data and information. 

In this rule, a GWS with a distribution 

system TCR sample that tests positive 

for total coliform is required to conduct 

triggered source water monitoring to 

evaluate whether the total coliform 

presence in the distribution system is 

due to fecal contamination in the 

ground water source. A GWS that does 

not provide at least 4-log treatment of 

viruses must conduct triggered source 

water monitoring upon being notified 

that a TCR sample is total coliformpositive. Within 24 hours of receiving 

the total coliform-positive notice, the 

system must collect at least one ground 

water sample from each ground water 

source (unless the GWS has an 

approved triggered source water 

monitoring plan that specifies the 

applicable source for collecting source 

samples). The GWS must test the 

ground water source sample(s) for the 

presence of one of three State-specified 

fecal indicators (E. coli, enterococci, or 

coliphage). If the source sample is fecal 

indicator-positive, this rule requires the 

GWS to notify the State and the public. 

Unless directed by the State to take 

immediate corrective action, the GWS 

must collect and test five additional 

source water samples for the presence of 

the same State-specified fecal indicator 

within 24 hours. If any one of the five 

additional source water samples tests 

positive for the State-specified fecal 

indicator (E. coli, enterococci, or 

coliphage), this rule requires the GWS to 

notify the State and the public and 

comply with the treatment technique 

requirements, which require the system 

to take one of four corrective actions 

discussed in the following section. The 

compliance date of the triggered source 

water monitoring requirement is 

December 1, 2009. 

As a complement to the triggered 

source water monitoring provision, 

States have the option of requiring 

GWSs to conduct assessment source 

water monitoring. This flexible 

provision gives States the opportunity to 

target higher risk GWSs for additional 

source water monitoring and evaluation. 

The State may require a GWS to conduct 

assessment source water monitoring as 

needed. EPA recommends that States 

use Hydrogeologic Sensitivity 

Assessments (HSAs) and TCR/triggered 

source water monitoring results, along 

with other information to identify 

higher risk systems for assessment 

source water monitoring. For 

assessment source water monitoring, 

EPA recommends that GWSs take 12 

monthly samples and test them for one 

of the GWR indicators (E. coli, 

enterococci, or coliphage). Corrective 

action for systems performing 

assessment source water monitoring is 

determined by the State. 

3. Treatment Technique Requirements 

This rule requires a GWS to comply 

with the treatment technique 

requirements if a significant deficiency 

is identified during a sanitary survey. 

Also, the rule requires a GWS to comply 

with the treatment technique 

requirements if one of the five 

additional ground water source samples 

(or at State discretion, the initial source 


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sample) has tested positive for fecal 

contamination (i.e., the sample is 

positive for one of the three fecal 

indicators and is not invalidated by the 

State). The treatment technique requires 

that a GWS implement at least one of 

the following corrective actions: correct 

all significant deficiencies; provide an 

alternate source of water; eliminate the 

source of contamination; or provide 

treatment that reliably achieves at least 

4-log treatment of viruses. Furthermore, 

the GWS must inform the public served 

by the water system of any uncorrected 

significant deficiencies and/or fecal 

contamination in the ground water 

source. The compliance date of the 

treatment technique requirements is 

December 1, 2009. 

4. Compliance Monitoring 

Compliance monitoring requirements 

are the final defense against viral and 

bacterial pathogens provided by this 

rule. All GWSs that provide at least 4- 

log treatment of viruses using chemical 

disinfection, membrane filtration, or a 

State-approved alternative treatment 

technology must conduct compliance 

monitoring to demonstrate treatment 

effectiveness. The compliance date of 

the compliance monitoring requirement 

is December 1, 2009. 

C. How Has the Final Rule Changed 

From What EPA Proposed? 

The primary elements of the proposed 

GWR were sanitary surveys, triggered 

monitoring, HSAs, routine monitoring, 

corrective action, and compliance 

monitoring. EPA received numerous 

comments on the proposed GWR and 

has carefully considered those 

comments in developing the final GWR. 

This consideration has led to a number 

of changes that the Agency believes will 

result in a more flexible, more targeted, 

more protective final GWR. 

Most of the changes are minor and are 

discussed throughout this preamble in 

the pertinent sections. The most 

significant change from the proposed 

rule to the final rule is to the routine 

monitoring provision. The proposed 

routine monitoring provision would 

have required GWSs in sensitive 

aquifers, as defined by a State 

performed HSA, to collect monthly 

source water samples. 

EPA received many negative 

comments on the HSA provision. Some 

States said that the proposed GWR did 

not allow sufficient time to conduct the 

HSA prior to the start of routine 

monitoring, which would result in 

GWSs in non-sensitive aquifers being 

required to monitor. Others stated that 

they would not do the HSA; rather, they 

would require all GWSs to conduct 

routine monitoring. In addition, EPA 

received comments that the routine 

monitoring provision was too 

burdensome. 

If the HSA provision would not be 

implemented in many States to target 

the routine monitoring to systems in 

sensitive aquifers that are most at risk, 

then the Agency agrees with the 

commenters that the routine monitoring 

provision would be overly burdensome. 

This is because some systems, located in 

non-sensitive aquifers, would be 

conducting routine monitoring 

unnecessarily. Moreover, EPA now 

believes that it is more difficult to 

capture contamination than estimated in 

the proposal, which further highlights 

the importance of correctly identifying 

systems for which source water 

monitoring would be prudent. 

Furthermore, commenters strongly 

supported revision of the GWR proposal 

to maximize State flexibility and 

discretion in making system-specific 

decisions. 

Given the importance of correctly 

targeting systems for source water 

monitoring, in conjunction with the 

State’s desire for enough flexibility to 

ensure sensible decisions on a case-bycase basis, EPA decided to redesign the 

source water monitoring provision. 

Accordingly, the final rule does not 

include a national requirement for HSAs 

and routine monitoring for systems in 

sensitive aquifers. Rather, EPA 

concludes that the States are in the best 

position to assess which systems would 

most benefit from a source water 

monitoring program. The final provision 

is similar to routine monitoring but is 

now optional for States and has been 

renamed assessment source water 

monitoring. States argued in their 

comments that the information available 

to them from other programs such as 

source water assessments, wellhead 

protection plans, and historical data 

would be important factors to consider 

when determining the need for source 

water monitoring. Because States are 

best able to identify higher risk systems, 

the final GWR provides States with the 

option to require GWSs to perform 

assessment source water monitoring. 

The Agency finds the comments 

received on the proposal to be 

persuasive and to support the approach 

in the final GWR. 

The purpose of the optional 

assessment source water monitoring 

requirement is to allow States to target 

such monitoring to GWSs that the State 

believes are at higher risk for fecal 

contamination. States specifically 

requested this flexibility and discretion 

in their comments to EPA. The 

flexibility of this provision provides 

many benefits. First, it gives States the 

ability to make case-by-case 

determinations of the need for source 

water monitoring. Given the variety of 

aquifer and well conditions across the 

United States and even within each 

State, State programs make more sense 

than a nationally-directed program. 

Second, the optional assessment source 

water monitoring requirement allows 

States to require assessment source 

water monitoring as needed. System 

conditions change over time and the 

ability of States to target this 

requirement to a specific system and 

time period will reduce burden and be 

critical to protecting public health by 

allowing States to focus attention on 

problem systems. The lack of time 

constraints will also allow States to 

prioritize susceptibility assessments and 

further target those systems most in 

need. 

EPA recommends that States use 

HSAs as one tool to identify high risk 

systems for assessment source water 

monitoring. HSAs can be an effective 

screening tool to identify sensitive 

hydrogeologic settings that transmit 

water, and any pathogens in that water, 

quickly from the surface to the aquifer. 

States have other information available 

to them to target high risk systems, such 

as source water assessments, wellhead 

protection plans, and historical 

monitoring data. Data on past 

indications of source water fecal 

contamination, particularly from TCR 

monitoring, in combination with GWR 

triggered source water monitoring 

results, can be another important tool. 

D. Does This Regulation Apply to My 

Water System? 

The requirements in this final rule 

apply to all PWSs (CWSs and NCWSs) 

that use ground water sources, in whole 

or in part (including consecutive 

systems that receive finished ground 

water from another PWS), except that 

they do not apply to PWSs that combine 

all of their ground water with surface 

water or ground water under the direct 

influence of surface water (GWUDI) 

prior to treatment under the Surface 

Water Treatment Rule (SWTR) (54 FR 

27486, June 29, 1989) (USEPA, 1989b). 

The GWR ensures that the same level of 

public health protection is provided to 

persons served solely by GWSs as to 

those served by mixed systems supplied 

by both ground water and surface water 

sources. See Section V.A of this 

preamble for more information on 

mixed systems. 

III. Background 

This section includes a discussion of 

the statutory requirements, regulatory 


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history, stakeholder involvement, and 

the public health concerns that this rule 

addresses. 

A. What Is the Statutory Authority for 

the GWR? 

Section 1412(b)(8) of the SDWA, as 

amended on August 6, 1996, requires 

EPA to promulgate National Primary 

Drinking Water Regulations (NPDWRs) 

requiring disinfection as a treatment 

technique for all PWSs, including 

surface water systems and, as necessary, 

GWSs. In addition, section 1412(b)(8) 

requires EPA to promulgate criteria as 

part of the regulations for determining 

whether disinfection should be required 

as a treatment technique for any PWS 

served by ground water. In contrast, the 

1986 Amendments to the SDWA 

directed EPA to promulgate regulations 

requiring disinfection at all PWSs using 

either surface water or ground water. 

The SWTR implemented that 

requirement for surface water systems, 

but when Congress amended the SDWA 

again in 1996, EPA had not promulgated 

regulations requiring disinfection for 

PWSs that use ground water. In the 

legislative history of the 1996 

Amendments to the SDWA, Congress 

identified several reasons for the delay, 

including the recognition that not all 

GWSs are at risk of contamination, as 

well as the high cost of across-the-board 

disinfection. This rule implements 

section 1412(b)(8) of the SDWA, as 

amended, by establishing a regulatory 

framework for determining which GWSs 

are susceptible to fecal contamination 

and requiring those systems to 

implement corrective action options, 

only one of which is to provide 4-log 

treatment of viruses (e.g., disinfection). 

Section 1413(a)(1) of the SDWA 

allows EPA to grant a State primary 

enforcement responsibility (‘‘primacy’’) 

for NPDWRs when EPA has determined 

that the State has adopted regulations 

that are no less stringent than EPA’s. To 

obtain primacy for this rule, States must 

adopt comparable regulations within 

two years of EPA’s promulgation of the 

final rule, unless EPA grants the State a 

two-year extension. State primacy 

requires, among other things, adequate 

enforcement (including monitoring and 

inspections) authority and reporting 

requirement. EPA must approve or deny 

State primacy applications within 90 

days of submission to EPA (SDWA 

section 1413(b)(2)). In some cases, a 

State submitting revisions to adopt an 

NPDWR has primacy enforcement 

authority for the new regulation while 

EPA’s decision on the revision is 

pending (SDWA section 1413(c)). 

Section 1445 of the SDWA authorizes 

the Administrator to establish 

monitoring, recordkeeping, and 

reporting regulations to assist the 

Administrator in determining 

compliance with the SDWA and in 

advising the public of the risks of 

unregulated contaminants. Section 1450 

of the SDWA authorizes the 

Administrator to prescribe such 

regulations as are necessary or 

appropriate to carry out his or her 

functions under the Act. 

B. What Is the Regulatory History of the 

GWR and How Were Stakeholders 

Involved? 

EPA has devoted a tremendous effort 

to engage stakeholders in the 

development of the GWR. EPA began 

developing the GWR in 1987 to address 

potential fecal contamination of GWSs 

by requiring across-the-board 

disinfection, as directed by the 1986 

Amendments to the SDWA. A 

preliminary public meeting on issues 

related to GWSs was held in 1990 (55 

FR 21093, May 22, 1990) (USEPA, 

1990). By 1992, EPA had developed a 

draft proposed rule that would have 

required disinfection for all GWSs (57 

FR 33960, July 31, 1992) (USEPA, 1992). 

The draft proposed rule incorporated 

stakeholder input and was made 

available for stakeholder review. While 

some stakeholders supported the 

increased public health protection for 

people drinking ground water, most 

stakeholders were concerned that the 

rule was crafted such that all GWSs 

were assumed to be contaminated until 

monitoring proved otherwise and that 

disinfection waivers would be difficult 

to obtain. 

Throughout the early and mid-1990s, 

EPA conducted technical discussions 

with ad hoc working groups during 

more than 50 conference calls, with 

participation of EPA Headquarters, EPA 

Regional offices, States, local 

governments, academicians, and trade 

associations. In 1996, Congress 

amended the SDWA and required EPA, 

under section 1412(b)(8), to develop 

regulations requiring disinfection as a 

treatment technique for GWSs ‘‘as 

necessary.’’ As discussed previously, 

this Amendment to the SDWA called for 

a different regulatory framework to 

address fecal contamination in GWSs. In 

light of this statutory change in 

direction, EPA determined that further 

stakeholder involvement would be 

crucial to establishing an effective 

approach for regulating fecal 

contamination in PWSs that use ground 

water sources. 

Technical meetings were held in 

Irvine, California in July 1996 (USEPA, 

1996), and in Austin, Texas in March 

1997 (USEPA, 1997a). These technical 

discussions focused primarily on 

establishing a reasonable means for 

determining if a ground water source 

was vulnerable to fecal contamination. 

EPA evaluated the possibility of 

developing a vulnerability assessment 

tool that would consider hydrogeologic 

information and sources of fecal 

contamination. 

In addition, EPA held a series of 

stakeholder meetings (in Portland, OR; 

Madison, WI; Dallas, TX; Lincoln, NE; 

and Washington, DC) designed to 

engage all stakeholders in developing a 

risk-based regulatory framework. The 

purpose of these meetings was to review 

available information on risk and to 

discuss methods to identify GWSs that 

are susceptible to fecal contamination, 

and therefore, should be required to take 

corrective actions. EPA also held three 

early involvement meetings with State 

representatives (in Portland, OR; 

Chicago, IL; and Washington, DC) and 

received valuable input from small 

system operators as part of an Agency 

outreach initiative under the Small 

Business Regulatory Enforcement 

Fairness Act. Over the course of these 

stakeholder meetings, the participants 

evaluated a continuum of regulatory 

approaches. The meetings fostered 

EPA’s understanding of how State 

strategies fit together as a part of a 

national strategy. Taken together, the 

meetings were crucial in guiding the 

Agency’s development of regulatory 

components for the GWR proposal. 

On February 3, 1999, EPA distributed 

a preliminary draft preamble using the 

approach developed during the 

stakeholder meetings. Eighty individual 

comment letters were received from 

representatives of State and local 

governments, trade associations, 

academic institutions, individual PWSs, 

and other Federal agencies. EPA 

considered all of the comments received 

from this informal process as the 

Agency revised the draft proposal. 

The proposed GWR was published in 

the Federal Register in 2000 (65 FR 

30194, May 10, 2000) (USEPA, 2000a). 

The comment period closed on August 

9, 2000, and EPA received comments 

from over 250 individuals, corporations, 

organizations, PWSs, States and Tribes, 

industry and trade associations, and 

environmental groups. EPA has 

carefully considered all of these 

comments in developing this final rule. 

Comments received on the proposed 

rule, along with EPA’s responses, are 

compiled in the Public Comment and 

Response Document for the Final 

Ground Water Rule (USEPA, 2006c). 

EPA published a Notice of Data 

Availability (NODA) in the Federal 

Register in 2006 (71 FR 15105, March 


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27, 2006) (USEPA, 2006e). The purpose 

of the NODA was to present additional 

studies that the Agency was considering 

in conducting its economic analysis for 

the final rule. The comment period 

closed on April 26, 2006. EPA received 

14 sets of comments from individuals, 

trade associations, State and local 

governments, an organization, and a 

university. Comments received on the 

NODA, along with EPA’s responses, are 

also compiled in the Public Comment 

and Response Document for the Final 

Ground Water Rule (USEPA, 2006c). 

C. What Public Health Concerns Does 

the GWR Address? 

This section explains the public 

health concerns associated with fecal 

contamination in GWSs by summarizing 

information on how ground water 

sources could become fecally 

contaminated, the causes of ground 

water outbreaks, and the health effects 

of consuming contaminated water. 

1. Introduction 

EPA estimates that approximately 114 

million people consume drinking water 

from PWSs that use ground water 

sources (Table III–1). These PWSs (total 

of about 147,000) distribute disinfected 

or undisinfected ground water to their 

customers. Approximately 18 percent 

(20 million) of people served by PWSs 

that use ground water sources receive 

undisinfected water, while over 60 

percent (70 million) receive either 

undisinfected water or water treated to 

less than 4-log inactivation or removal 

of viruses. 

Over 100 million people receive 

ground water from community water 

systems (CWSs) (Table III–1), while 

about 14 million people receive ground 

water from non-community water 

systems (NCWSs); non-transient noncommunity water systems (NTNCWSs) 

serve ground water to about five million 

people and transient non-community 

water systems (TNCWSs) serve ground 

water to about nine million people. 

Table III–1 shows that, of the number of 

people receiving water from CWSs, 

NTNCWSs, and TNCWSs, 

approximately 9.3 million (9.2 percent), 

3.6 million (71 percent), and 7.2 

million, (83 percent), respectively, 

receive water that is not disinfected at 

all. The Table also shows that 56.8 

million people served by CWSs, 4.7 

million people served by NTNCWSs, 

and 8.6 million people served by 

TNCWSs receive water that is either 

undisinfected or treated to less than 4- 

log. 

TABLE III–1.—POPULATION SERVED BY GROUND WATER SYSTEMS

[Millions] 

Total population 

served by ground 

water systems 

Population served 

untreated ground 

water 

Population served 

ground water that is 

either undisinfected 

or treated to less 

than 4-log 

CWSs ............................................................................................................. 100.4 9.3 56.8

NTNCWSs ..................................................................................................... 5.1 3.6 4.7 

TNCWSs ........................................................................................................ 8.7 7.2 8.6 

Source: Exhibit 4.4 of the GWR EA (USEPA, 2006d). 

As discussed previously in Section 

II.A, the CDC identified source water 

contamination and inadequate treatment 

as the major causes for ground waterrelated outbreaks between 1991 and 

2000. Untreated or inadequately treated 

ground water may contain viral and 

bacterial pathogens. Therefore, 

undisinfected ground water or water 

treated to less than 4-log may pose a 

public health risk to consumers. 

Waterborne disease attributable to 

viral and bacterial pathogens is a 

significant public health problem. EPA’s 

Science Advisory Board cited drinking 

water contamination, particularly 

contamination by pathogenic 

microorganisms, as one of the most 

important environmental risks (USEPA/ 

SAB, 1990). The CDC reports significant 

numbers of recent waterborne disease 

outbreaks and cases of illness associated 

with ground waters (Moore et al. (1993); 

Kramer et al. (1996); Levy et al. (1998); 

Barwick et al. (2000); Lee et al. (2002)). 

Most waterborne pathogens, including 

viral and bacterial pathogens, cause 

gastrointestinal (GI) illness with 

diarrhea, abdominal discomfort, nausea, 

vomiting, and other symptoms. The 

effects of a waterborne disease are 

usually acute, resulting from a single 

exposure. Most GI illnesses are 

generally of short duration and result in 

mild illness, but some can result in 

severe illness and even death. For 

example, during a recent ground water 

outbreak in New York, a healthy threeyear old child died from hemolytic 

uremic syndrome (kidney failure) (New 

York State Department of Health, 2000). 

Waterborne pathogens also cause other 

serious disorders such as hepatitis, 

Legionnaires Disease, myocarditis, 

paralysis, acute hemorrhagic 

conjunctivitis, meningitis, and reactive 

arthritis. Waterborne pathogens have 

also been associated with diabetes, 

encephalitis, and other diseases 

(Lederberg, 1992). 

Sensitive populations are at greater 

risk from waterborne disease from viral 

and bacterial pathogens than the general 

population. These sensitive 

subpopulations include children 

(especially the very young); the elderly; 

the malnourished; pregnant women; 

chronically ill patients (e.g., those with 

diabetes or cystic fibrosis); and a broad 

category of those with compromised 

immune systems, such as AIDS patients, 

those with autoimmune disorders (e.g., 

rheumatoid arthritis, lupus 

erythematosus, and multiple sclerosis), 

organ transplant recipients, and those 

receiving chemotherapy (Rose, 1997). 

Sensitive subpopulations (or those with 

compromised immune systems) 

represent almost 20 percent of the 

population in the United States (Gerba 

et al., 1996). The severity and duration 

of illness is often greater in sensitive 

subpopulations than in healthy 

individuals, and may occasionally result 

in death. 

When humans are exposed to and 

infected by an enteric pathogen, such as 

a bacterium or virus, 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 

weeks. 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 feces, 

the pathogen being shed may infect 

other people directly (by person-toperson spread, contact with 

contaminated surfaces, etc.), which is 

referred to as secondary spread. 


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Waterborne pathogens thus may infect 

people via a variety of routes. 

Fecal contamination of drinking water 

is a primary cause of waterborne disease 

(Szewzyk et al., 2000). Viral and 

bacterial pathogens associated with 

fecal contamination can reach ground 

water via pathways in the subsurface 

and near surface. First, fecal 

contamination from, for example, 

improper storage or management of 

manure, runoff from land-applied 

manure, leaking sewer lines, or failed 

septic systems can reach the ground 

water source by traveling—sometimes 

great distances—through the subsurface 

(especially through transmissive 

materials such as karst, gravel, or 

fractured bedrock). Twenty-five million 

households in the United States use 

conventional onsite wastewater 

treatment systems, according to the 

1990 Census. These systems include 

septic systems and leach fields. A 

national estimate of failure rates of these 

systems is not available; however, a 

National Small Flows Clearinghouse 

survey reports that in 1993 alone, 

90,632 failures were reported (USEPA, 

1997b). The volume of septic tank waste 

alone that is released into the subsurface 

has been estimated at one trillion 

gallons per year (Canter and Knox, 

1984). This contamination may 

eventually reach the intake zone of a 

drinking water well. 

Second, fecal contamination from the 

surface may enter a drinking water well 

along the casing or through cracks in the 

sanitary seal if it is not properly 

constructed, protected, or maintained. 

In addition to source contamination, 

fecal contamination may also enter the 

distribution system when crossconnection controls fail or when 

negative pressure in a leaking pipe 

allows contaminant infiltration. A 

subset of GWSs is susceptible to 

contamination by one or more of these 

routes. 

2. Waterborne Disease Outbreaks in 

Ground Water Systems 

The Centers for Disease Control and 

Prevention (CDC) reports that between 

1991 (the year in which implementation 

of the TCR began) and 2000, GWSs (both 

CWSs and NCWSs) were associated 

with 68 outbreaks that caused 10,926 

illnesses (Table III–2). These account for 

51 percent of all waterborne disease 

outbreaks in the United States during 

that period. The outbreak data illustrate 

that the major deficiency in GWSs was 

source water contamination. 

Contaminated source water was the 

cause of 79 percent of the outbreaks in 

GWSs (63 percent of CWS outbreaks and 

86 percent of NCWS outbreaks), shown 

as untreated ground water and treatment 

deficiencies in Table III–2. Consumers 

of undisinfected water are especially 

vulnerable to source water 

contamination. Approximately 70 

percent of GWSs provide either 

untreated ground water or provide 

treatment of less than 4-log virus 

inactivation or removal as discussed in 

the GWR EA (USEPA, 2006d). 

Of the 68 outbreaks in GWSs, 14 (21 

percent) were associated with specific 

bacterial pathogens (see Table III–3). 

The fecal bacterial pathogen Shigella 

caused more reported outbreaks (five, 

seven percent) than any other bacterial 

agent. Identified viral pathogens were 

associated with four (six percent) 

reported outbreaks. Etiologic agents 

were not identified in 39 (57 percent) 

outbreaks; however, EPA suspects that 

many of these outbreaks were caused by 

viruses given that it is generally more 

difficult to analyze for viral pathogens 

than bacterial pathogens. EPA regulates 

for protozoa, including Giardia and 

Cryptosporidium, under the SWTRs, 

which also cover GWUDI systems. For 

the most part, the outbreaks associated 

with protozoa that occurred in GWSs 

were later determined by the State to be 

GWUDI systems. 

BILLING CODE 6560–50–P 


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BILLING CODE 6560–50–C 

Large outbreaks are rarely associated 

with GWSs because most GWSs are 

small. In addition, the number of 

identified and reported outbreaks in the 

CDC database is believed to 

substantially understate the actual 

incidence of waterborne disease 

outbreaks and cases of illness (Craun 

and Calderon, 1996; National Research 

Council, 1997). This underestimation is 

due to a number of factors. Many people 

experiencing gastrointestinal illness do 

not seek medical attention. Where 

medical attention is provided, testing to 

identify the pathogenic agent is often 

not done and even if it is, the 

pathogenic agent may not be identified 

through correct testing (e.g., when a 

sample is tested for a limited number of 

pathogens). Physicians often lack 

sufficient information to attribute 

gastrointestinal illness to any specific 

origin, such as drinking water, and few 


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States have an active outbreak 

surveillance program. Furthermore, the 

outbreak reporting system in the U.S. is 

paper-based and voluntary. 

Consequently, waterborne disease 

outbreaks are often not recognized in a 

community or, if recognized, are not 

traced to a drinking water source even 

though it may be the cause of the 

outbreak. Although it occurred in a 

community served by a surface water 

source, the 1993 Cryptosporidium 

outbreak in Milwaukee, Wisconsin is an 

example of how difficult it is to 

recognize a drinking waterborne disease 

outbreak. In one study of this large 

outbreak, only six percent sought health 

care and only six percent of those health 

care cases were tested for parasites (with 

only four percent of those cases 

specifically tested for Cryptosporidium) 

(Juranek, 1997). Thus, over 99 percent of 

estimated cases of illness went 

undiagnosed in this outbreak. In 

addition to epidemic illness, an 

unknown but probably significant 

portion of waterborne disease is 

endemic (i.e., isolated cases not 

associated with an outbreak) and is even 

more difficult to recognize. 

Collectively, the data indicate that 

outbreaks in GWSs are a problem and 

that source water contamination and 

inadequate treatment (or treatment 

failures) are responsible for the great 

majority of outbreaks. 

3. Microbial Contamination in Public 

Ground Water Systems 

The extent to which viral and 

bacterial pathogens occur in public 

ground water supplies influences the 

risk of exposure to populations 

consuming ground water from PWSs. 

Such risks of exposure pertain to 

populations using both undisinfected 

and disinfected water supplies. For 

undisinfected supplies, pathogens in the 

water are an immediate risk, since no 

treatment barrier exists prior to 

consumption. For disinfected supplies, 

if disinfection is inadequate or if 

treatment plant upsets occur, pathogens 

can reach consumers. These exposure 

risks were discussed in Section III.C.2 

from an outbreak perspective. This 

section will discuss data on the 

occurrence of waterborne viral 

pathogens and indicators of fecal 

contamination in ground water 

supplying PWS wells. 

a. Occurrence studies and data. For 

this rule, EPA examined the occurrence 

of viral pathogens and some fecal 

indicators. EPA reviewed data from 24 

studies on pathogen and fecal indicator 

occurrence in ground water wells that 

supply PWSs. This total includes 16 

studies described in the proposal, seven 

studies that became available since 

proposal as described in the NODA 

(USEPA, 2006e), and one study that was 

provided to EPA in comment as a result 

of the NODA. Each study was 

conducted independently and with a 

different objective and scope. The 

Occurrence and Monitoring Document 

for the Final Ground Water Rule 

(USEPA, 2006b) provides a detailed 

discussion of each examined occurrence 

study. The available data show a wide 

range of enterovirus and fecal indicator 

occurrence in water drawn from wells 

across the U.S. EPA selected 15 studies 

to estimate national viral and fecal 

indicator occurrence in ground water. 

To arrive at the conclusion that these 15 

studies provide the best possible 

representation of ground water 

contamination at a national level, EPA 

evaluated all available studies (24 

studies) that were applicable to the risk 

assessment analyses (USEPA, 2006d). 

See Section VII.B.1 of this preamble for 

a discussion of study selection. 

Enterovirus cell culture data from the 

15 studies were used to estimate the 

baseline risk related to virus occurrence 

in ground water. EPA believes that 

enterovirus cell culture measurements 

provide the best available basis for 

estimating pathogenic viral occurrence 

since they capture viruses that are 

infectious. However, because the cell 

culture procedure only captures a 

portion of all viruses that may actually 

occur in well water due to assay 

limitations, use of this method may 

underestimate viral occurrence. 

EPA used data on the indicator E. coli 

from these same studies to inform 

estimates of fecal contamination 

occurrence. Indicator data are important 

because illness can result from 

consuming ground water with fecal 

contamination in the absence of 

identified viruses. For example, some 

viruses such as infectious norovirus are 

not recoverable, other viruses such as 

enteroviruses have variable and limited 

recovery, and a variety of bacteria of 

fecal origin can cause disease. EPA 

chose to use E. coli data instead of other 

fecal indicator data for this analysis. 

This choice was driven by EPA’s 

assessment that E. coli will be the most 

likely fecal indicator used when PWSs 

implement the GWR, because E. coli is 

frequently used to fulfill follow-up 

monitoring requirements under the 

TCR. Therefore national estimates of E. 

coli occurrence can be used to inform 

potential cost implications for 

implementing the GWR. EPA recognizes 

that any indicator organism, including 

E. coli, may or may not co-occur with 

pathogens and that co-occurrence could 

be intermittent. E. coli is an imperfect 

indicator of viral occurrence. Some 

wells with E. coli have no viral 

occurrence. Some wells with viral 

occurrence have no E. coli. 

b. Estimates of national occurrence of 

viral and fecal indicator contamination. 

This section discusses national 

occurrence of viral and fecal indicator 

(E. coli) contamination, which includes 

estimates of viral concentrations in 

contaminated wells and estimates of the 

probability that a well may have 

detectable viral and/or fecal indicator 

contamination. For purposes of this 

analysis, EPA uses the term ‘‘sometime 

contamination’’ as contamination that 

occurs at one or more points in time. 

Because fecal contamination is 

intermittent, viruses and E. coli will 

only be present at detectable levels 

some fraction of the time in a 

contaminated well. These fractions will 

vary from well to well. Some wells may 

be frequently contaminated but others 

may only be contaminated for a small 

fraction of time. 

EPA analyzed the 15 studies for data 

to inform the concentration analysis. 

Among the 15 studies used for the 

national occurrence analysis, 12 

provided data on occurrence of 

enterovirus cell culture and 11 provided 

data on occurrence of E. coli. Among the 

12 data sets with enterovirus cell 

culture measurement, three included 

viral concentration data. Concentration 

measurements in the three surveys 

ranged from 0.09 to 212 enteric virus 

infectious units (plaque forming units) 

per 100 liters. Although the 

measurement methods were often not 

capable of detecting viruses at 

concentrations below 0.2 units per 100 

liters, it is likely that viruses also occur 

at levels below the detection limit. 

Data from each of the 15 studies were 

combined into one complete data set to 

determine the probabilities of sometime 

well contamination for viral (indicated 

by enterovirus cell culture) or fecal 

indicator (indicated by E. coli) 

contamination. The results of this effort 

led naturally to a combined analysis, 

which models occurrence and cooccurrence of viruses and E. coli. EPA’s 

analysis also considers uncertainty and 

variability about these estimates. The 

model serves as the basis of EPA’s 

national quantitative occurrence 

estimates. See the Occurrence and 

Monitoring Document for the Final 

Ground Water Rule for more 

information (USEPA, 2006b). 

Overall, the analysis indicates a 

public health concern in that 

approximately 26 percent of the wells 

sometimes have fecal contamination 

(indicated by E. coli) and approximately 

27 percent of the wells sometimes have 


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viral contamination. Due to the 

intermittent nature of fecal 

contamination, some of these wells are 

only contaminated for a small fraction 

of time. On average, wells with 

sometime virus occurrence have 

detectable concentrations about 11 

percent of the time, and wells with 

sometime E. coli occurrence have 

detectable concentrations about 14 

percent of the time. The remainder of 

the time, the well’s water is essentially 

virus free (assuming that concentration 

is zero when not detected by 

measurement methods like those used 

in the occurrence studies). Compared to 

the analysis in the proposal, the number 

of wells with fecal contamination is 

greater but the frequency at which 

contamination occurs in each well is 

less. 

In summary, EPA’s occurrence 

analysis shows that fecal contamination 

is intermittent and that some 

individuals are at risk because 

pathogens and/or fecal indicators occur 

at PWSs that use ground water as a 

source of drinking water. The next 

section discusses this risk. 

4. Potential Risk Implications From 

Occurrence Data 

As discussed previously, to assess the 

public health risk associated with 

drinking ground water, EPA evaluated 

information and conducted analyses on 

(1) Health effects data from a range of 

pathogens, (2) waterborne disease 

outbreak data, and (3) occurrence data 

from ground water studies and surveys. 

As a result of this evaluation and 

analysis, EPA concludes that the 

potential risk to public health posed by 

a subset of PWSs with contaminated 

ground water sources is significant 

enough to warrant regulation. 

When a PWS uses contaminated 

source water, its customers are at risk of 

infection and illness. Their risk depends 

on a number of factors including 

whether the system provides at least 4- 

log treatment of viruses, the frequency 

at which the well is contaminated, the 

level of contamination (i.e., 

concentration), and the infectivity of the 

pathogens that are present. 

To develop risk estimates from viral 

exposure, EPA considered two types of 

viruses, Type A (represented by data 

available on rotavirus) and Type B 

(represented by data available on 

enterovirus or echovirus), which are 

used to estimate risk from exposure to 

viral-contaminated wells. These two 

virus types have different infection 

morbidity and disease severity 

characteristics. Type A viruses are 

considered to be highly infectious but 

cause primarily mild illness, while Type 

B viruses are considered much less 

infectious but may cause more severe 

illnesses. 

The infectivity of a virus relates the 

probability of infection to a given 

amount, or dose, of virus consumed. 

Together with infectivity, morbidity 

(risk of illness given infection) and 

mortality (risk of premature death given 

an illness) are used to predict the 

disease burden associated with a 

particular virus level in drinking water. 

As discussed in the previous section, a 

typical contaminated well may have 

detectable virus concentrations 11 

percent of the time. The remainder of 

the time, the well’s water is essentially 

virus free (assuming that concentration 

is zero when not detected by 

measurement methods like those used 

in the occurrence studies). EPA has viral 

concentration data from the three 

studies as discussed in Section III.C.3.b 

of this preamble. Virus concentration 

data combined with viral exposure data 

can be used to predict infection rates 

given viral dose-response information. 

Figure III–1 indicates the annual risk of 

infection from exposure to rotavirus, 

assuming one liter of water consumed 

per day, based on a range of possible 

mean annual source water 

concentrations and different levels of 

treatment. For example, if an untreated 

ground water source had a mean annual 

source water concentration of 0.1 

viruses per 100 L (e.g., a source water 

concentration of one virus per 100 L, 10 

percent of the time), people consuming 

one liter of this water per day would 

have approximately a seven percent 

probability of being infected in the 

course of the year (90 percent 

confidence interval of three percent to 

13 percent). The risk of infection 

implications from exposure to echovirus 

are 10 to 100 times less than those from 

rotavirus, assuming the same levels of 

exposure. However, illness resulting 

from infection of echovirus may be more 

severe than illness resulting from 

infection by rotavirus. 

It is important to recognize that EPA’s 

quantitative risk analysis is limited by 

the data available, specifically data on 

rotavirus and echovirus. Other 

pathogenic viruses also cause disease 

and may be more or less infectious than 

those modeled. Pathogens may cause 

chronic and acute illnesses in addition 

to those considered in the quantitative 

risk analysis. Furthermore, EPA’s 

quantitative risk analysis does not 

consider bacterial illness and deaths 

resulting from contaminated drinking 

water due to limited data. Taken 

together, these limitations imply an 

underestimate of the actual illnesses 

and deaths that result from exposure to 

contaminated ground water when only 

these sources of uncertainty are 

considered. The GWR national risk 

implications from exposure to 

pathogenic viruses and bacteria are 

discussed in Section VII of this 

preamble and more fully discussed in 

the GWR EA (USEPA, 2006d). 

Even at the levels EPA is able to 

quantify, the risk analysis supports the 

conclusion that a substantial number of 

people served by GWSs are at risk of 

exposure to waterborne pathogens. 

EPA’s occurrence analysis (USEPA, 

2006b) demonstrates that some wells 

have high viral occurrence while others 

have lower occurrence, and thus lower 

risk. For public health protection, it is 

most important to target those wells 

with higher occurrence. In addition, the 

occurrence analysis demonstrates that 

contamination is intermittent. Because 

of the intermittent nature of 

contamination, an ongoing monitoring 

program is critical to effectively target 

higher risk systems. 

The intent of the GWR is to reduce 

risk by targeting susceptible systems for 

corrective action. The corrective action 

options are: Correct all significant 

deficiencies; provide an alternate source 

of water; eliminate the source of 

contamination; or provide treatment 

that reliably achieves at least 4-log 

treatment of viruses. As illustrated in 

Figure III–1, treatment will provide 

large improvements in public health. 

Thus, the final GWR components of 

sanitary surveys, source water 

monitoring, and corrective action are 

each critical steps to improving public 

health in communities served by 

undisinfected (or inadequately 

disinfected) GWSs. 

Implementation of this rule is 

expected to result in approximately 

42,000 avoided viral illnesses and one 

avoided death annually. The analysis is 

uncertain and these estimates could be 

an over-or under-estimate of actual 

illnesses and deaths. The nonquantified 

benefits are those that the Agency was 

unable to quantify due to data 

limitations, which include decreased 

incidence of other acute viral disease 

endpoints, decreased incidence of 

chronic viral illness sequelae, decreased 

incidence of bacterial illness and death, 

decreased incidence of waterborne 

disease outbreaks and epidemic illness, 

and decreased illness through 

minimizing treatment and distribution 

system failures. The nonquantified 

benefits associated with this rule are 

significant and are discussed in detail in 

Section 5.4 of the GWR EA (USEPA, 

2006d). 


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IV. Discussion of GWR Requirements 

This section describes the rule 

requirements and rationale for each 

component of the risk-targeted strategy 

of this rule. A summary of, and 

responses to, key comments on the 

proposed rule are also provided. 

A. Sanitary Surveys 

EPA believes that comprehensive, 

periodic sanitary surveys and the 

identification and correction of 

significant deficiencies are 

indispensable for ensuring the long-term 

safety of drinking water supplies. They 

are an important tool for identifying 

potential vulnerabilities to fecal 

contamination at GWSs. The final GWR 

includes Federal requirements for 

sanitary surveys of all GWSs for the first 

time. 

This rule provides the States with 

flexibility to prioritize and carry out the 

sanitary survey process, while ensuring 

that the survey is an effective, 

preventive tool for GWSs. The sanitary 

survey provision in this rule builds on 

existing State sanitary survey programs 

established under the 1989 TCR and the 

Interim Enhanced Surface Water 

Treatment Rule (IESWTR) (63 FR 69477, 

December 16, 1998) (USEPA, 1998b) 

and gives States the authority to define 

both outstanding performance and 

significant deficiencies. At the same 

time, the GWR’s sanitary survey 

requirements for minimum frequencies, 

scope, documentation, and mandatory 

corrective action strengthen existing 

sanitary survey programs and address 

many of the concerns associated with 

current sanitary survey programs as 

identified by the GAO (USGAO, 1993). 

BILLING CODE 6560–50–P 


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BILLING CODE 6560–50–C 

1. What Are the Requirements of This 

Rule? 

This rule requires States to perform 

sanitary surveys for all GWSs. Ground 

water systems must provide the State 

with any pertinent, existing information 

that will enable the State to perform the 

sanitary survey. This rule goes beyond 

the existing definition of sanitary survey 

at § 141.2, explicitly references the use 

and relevance of source water 

assessments required under the 1996 

SDWA Amendments, and specifies in 

more detail the scope of a sanitary 

survey. Specifically, this rule requires 

that States evaluate eight components as 

part of the sanitary survey to the extent 

that they apply to an individual system: 

(1) Source; (2) treatment; (3) distribution 

system; (4) finished water storage; (5) 

pumps, pump facilities, and controls; 

(6) monitoring, reporting, and data 

verification; (7) system management and 

operation; and (8) operator compliance 

with State requirements. This rule 

outlines the eight minimum elements 

using broad categories and recognizes 

that certain elements may not be present 

in a particular system depending on its 

size or complexity. 

This rule requires States to conduct 

sanitary surveys of ground water CWSs 

every three years (every five years for 

CWSs that meet performance criteria as 

described in the following paragraph) 

and of ground water NCWSs every five 

years. States are required to complete 

the initial sanitary survey cycle by 

December 31, 2012 for CWSs, except 

those that meet performance criteria, 

and December 31, 2014 for all NCWSs 

and CWSs that meet performance 

criteria. States may conduct more 

frequent sanitary survey cycles for any 

GWS as appropriate. 

This rule allows individual 

components of a sanitary survey to be 

conducted according to a phased review 

process (e.g., as part of ongoing State 

assessment programs). While all 


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applicable components need not be 

evaluated at the same time, they must be 

evaluated within the required three-or 

five-year frequency interval. Also, this 

rule allows the three-year CWS schedule 

to be extended to a five-year frequency 

if the system meets certain criteria 

(referred to in this preamble as 

‘‘performance criteria’’). These 

performance criteria are: 

• Provides 4-log treatment of viruses 

(using inactivation, removal, or a Stateapproved combination of 4-log virus 

inactivation and removal) before or at 

the first customer for all its ground 

water sources, or 

• Has an outstanding performance 

record (as defined by the State) 

documented in previous sanitary 

surveys, and has no history of total 

coliform MCL or monitoring violations 

under the TCR since the last sanitary 

survey. 

Finally, this rule requires that GWSs 

correct any significant deficiencies 

identified in sanitary surveys. 

Significant deficiencies, as determined 

by the State, include, but are not limited 

to, defects in design, operation, or 

maintenance, or a failure or malfunction 

of the sources, treatment, storage, or 

distribution system that the State 

determines to be causing, or have the 

potential for causing, the introduction of 

contamination into the water delivered 

to consumers. 

Significant deficiencies may include, 

but are not limited to, the following: 

Source 

• Well near a source of fecal 

contamination (e.g., failing septic 

systems or a leaking sewer line). 

• Well in a flood zone. 

• Improperly constructed well (e.g., 

improper surface or subsurface seal). 

• Spring boxes that are poorly 

constructed and/or subject to flooding. 

Treatment 

• Inadequate application of treatment 

chemicals (e.g., disinfection contact 

time is inadequate). 

• Lack of redundant mechanical 

components where disinfection is 

required. 

• Unprotected cross-connections with 

treatment chemical systems. 

• Inadequate treatment process 

monitoring. 

Distribution System 

• Negative pressures that could result 

in the entrance of contaminants. 

• Inadequate disinfectant residual 

monitoring, when required. 

• Unprotected cross-connections. 

Finished Water Storage 

• Inadequate internal cleaning and 

maintenance of storage tanks. 

• Lack of proper screening of 

overflow pipes, drains, or vents. 

• Storage tank roofs or covers need 

repair (e.g., holes or hatch of improper 

construction). 

Pumps, Pump Facilities, and Controls 

• Inadequate pump capacity. 

• Inadequate maintenance. 

• Inadequate/inoperable control 

system. 

Monitoring, Reporting, and Data 

Verification 

• Failure to properly monitor water 

quality. 

• Failure to meet reporting 

requirements. 

• Inadequate recordkeeping. 

System Management and Operation 

• Failure to meet water supply 

demands/interruptions to service (e.g., 

unreliable water source or lack of 

auxiliary power). 

• Lack of approved emergency 

response plan. 

• Inadequate follow-up to 

deficiencies noted in previous 

assessment/survey. 

Operator Compliance with State 

Requirements 

• Operator is not certified as required 

by the State. 

• Lack of operator training. 

The State must provide the GWS with 

written notification, which describes 

any significant deficiencies found, no 

later than 30 days after the State 

identifies the significant deficiency. The 

notice may be sent to the PWS, or it may 

be provided on-site either at the time 

the sanitary survey is conducted or the 

significant deficiency is identified. The 

State may specify appropriate follow-up 

corrective action steps in the notice or 

may notify the GWS of appropriate 

corrective actions during the 

consultation period. After receiving the 

written notification, the GWS has 30 

days to consult with the State regarding 

corrective actions. However, the State 

may prescribe corrective actions and 

completion dates, including immediate 

and/or interim corrective actions, in lieu 

of the consultation process. Under this 

rule, a GWS must complete corrective 

action or be in compliance with a Stateapproved corrective action plan and 

schedule within 120 days of receiving 

written notice from the State, as 

described in Section IV.C of this 

preamble. Failure to do so will result in 

a treatment technique violation. This 

rule requires systems to notify 

customers of uncorrected significant 

deficiencies. When a significant 

deficiency is identified at a PWS that 

uses both ground water and surface 

water sources, the GWR treatment 

technique requirements apply except in 

cases where the State determines that 

the significant deficiency is in a portion 

of the distribution system that is served 

by surface water (or ground water under 

the direct influence of surface water). 

2. What Is EPA’s Rationale for the GWR 

Sanitary Survey Requirements? 

As discussed in the proposed GWR, 

sanitary surveys enable States (and 

systems) to provide a comprehensive 

and accurate review of the components 

of water systems, to assess the operating 

conditions and adequacy of the water 

system, and to determine if past 

recommendations have been 

implemented effectively. A GWS has the 

responsibility of providing the 

information necessary to conduct a 

sanitary survey to the State upon 

request to enable a comprehensive 

assessment of the system. The purpose 

of the sanitary survey is to evaluate and 

document the capabilities of the water 

system’s sources, treatment, storage, 

distribution network, operation and 

maintenance, and overall management 

to ensure the provision of safe water. In 

addition, sanitary surveys provide an 

opportunity for PWS inspectors to visit 

the water system and educate operators 

about proper monitoring and sampling 

procedures and to provide technical 

assistance. 

Historically, sanitary surveys have 

been conducted by State drinking water 

programs as preventative tools for 

identifying water system deficiencies 

before contamination occurs. In 1976, 

EPA regulations required, as a condition 

of primacy, that States develop a 

systematic program for conducting 

sanitary surveys, but EPA did not define 

the scope of sanitary surveys or specify 

minimum criteria at that time. In 1989, 

the TCR included a provision requiring 

sanitary surveys for systems collecting 

fewer than five TCR samples per month 

(systems serving fewer than 4,100 

people). For those systems, sanitary 

surveys are required under the TCR 

once every five years for CWSs and 

NCWSs (but once every 10 years for 

NCWSs that use protected or disinfected 

ground water). However, the TCR did 

not establish what must be evaluated in 

a sanitary survey or specifically address 

significant deficiencies. 

Consequently, a number of concerns 

have been raised regarding post-TCR 

sanitary survey practices. For example, 

the GAO investigated sanitary survey 

practices in 1993 and found that many 

surveys did not evaluate one or more of 

the major components and operations 

that EPA requires be evaluated under 

the final GWR and that efforts to ensure 

that deficiencies were corrected were 

often limited (USGAO, 1993). A review 

of State regulations found that many 

States do not specifically require 

systems to correct deficiencies. These 


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factors, coupled with information on 

contaminant occurrence and analysis of 

microbial waterborne disease outbreak 

data, indicated that public health 

protection can be strengthened by 

requiring regular sanitary surveys, 

specifying the scope of surveys, and 

requiring corrective action of significant 

deficiencies. 

In 1995, EPA and the States (through 

the Association of State Drinking Water 

Administrators) issued a joint guidance 

on sanitary surveys entitled EPA/State 

Joint Guidance on Sanitary Surveys 

(USEPA/ASDWA, 1995). Recognizing 

the essential role of sanitary surveys and 

the need to define the broad areas that 

all sanitary surveys should cover, the 

guidance recommended eight elements 

for a comprehensive sanitary survey. 

The guidance also recommended the 

development of assessment criteria, 

proper documentation of results, and 

thorough follow-up, tracking, and 

enforcement after the survey. The 

IESWTR, (USEPA, 1998b), requires 

States to address the same eight 

elements in sanitary surveys conducted 

at surface water systems and at GWUDI 

systems. The GWR incorporates the 

same eight elements into the sanitary 

survey requirements for GWSs to be 

consistent with, and as comprehensive 

as, the IESWTR. Based on consultation 

with the States and EPA regions, EPA 

believes that the majority of States today 

include the eight elements in their 

sanitary survey programs for both 

surface water and GWSs. 

In addition to requiring these eight 

elements, the GWR requires the State to 

conduct sanitary surveys no less 

frequently than every three years for 

CWSs and every five years for NCWSs. 

This rule provides the State with the 

flexibility to reduce the frequency for 

CWSs to every five years for systems 

that meet performance criteria (refer to 

Section IV.A.1 for criteria). These 

frequencies are consistent with the 

recommendations for surface water 

systems made by the Microbial/ 

Disinfection Byproducts Federal 

Advisory Committee, which included 

various stakeholders representing a 

wide range of sectors in the drinking 

water community. Given this, EPA 

believes that the same three- and fiveyear interval for conducting sanitary 

surveys is appropriate for GWSs. The 

GWR requires the first sanitary survey 

cycle to be completed by December 31, 

2012 for CWSs, except those that meet 

performance criteria, and December 31, 

2014 for all NCWSs and CWSs that meet 

performance criteria. See Section VI of 

this preamble for explanation of initial 

sanitary survey completion dates. 

As noted earlier, this regulation 

attempts to build on existing State 

public health programs to the extent 

possible. Consequently, the GWR allows 

individual elements of a sanitary survey 

to be conducted on a phased review 

schedule as part of ongoing State 

assessment programs within the 

established three-or five-year frequency 

interval. This allows States to more 

efficiently use existing assessment 

schedules and maximize the effective 

allocation of staff resources and 

expertise across a State in conjunction 

with other priorities. EPA believes that 

the frequency of sanitary surveys and 

the required eight sanitary survey 

elements in this rule ensure greater 

public health protection while 

providing adequate flexibility for States 

and systems to effectively implement 

the requirements. The GWR requires the 

initial sanitary surveys to be completed 

six years after rule promulgation for 

CWSs and eight years after rule 

promulgation for NCWSs. The six to 

eight year time frame for initial sanitary 

surveys is based on several 

considerations. First, States need time to 

adopt the rule and obtain primacy (two 

to four years allowed by the SDWA at 

1413(a)(1)). In addition, systems are 

given three years to comply with 

drinking water regulations by the SDWA 

at (1412(b)(10)). Finally, States need 

three to five years to complete the first 

cycle of sanitary surveys because there 

are many GWSs and States have limited 

resources. 

A key finding of the GAO report was 

that deficiencies identified in one 

sanitary survey were often found still 

uncorrected at the next sanitary survey. 

For example, in a four-State sample of 

200 sanitary surveys, GAO found 

approximately 60 percent of the surveys 

cited deficiencies that were also cited in 

previous surveys. While the report 

indicated that smaller systems (serving 

3,300 or fewer people) were in the 

greatest need of improvement, GAO 

found that, regardless of system size, 

previously identified deficiencies 

frequently went uncorrected. GAO 

found that some States lacked the 

authority to ensure that water system 

owners and operators correct 

documented deficiencies. Additional 

causes for uncorrected deficiencies 

included a lack of documentation or 

ineffective tracking of survey results. 

The Agency believes that a sanitary 

survey is an effective tool for identifying 

significant deficiencies. Once identified, 

it is also essential that such deficiencies 

be corrected in a timely manner. A 

study of the effectiveness of a range of 

best management practices shows that 

follow-up and correction of sanitary 

survey deficiencies were correlated with 

lower levels of total coliform, fecal 

coliform, and E. coli (ASDWA, 1998). 

Thus, this rule requires that systems 

coordinate with the State within 30 days 

of being notified of the significant 

deficiency and that the systems correct 

the significant deficiency (or be on an 

enforceable State-prescribed schedule) 

within 120 days of being notified of the 

significant deficiency. See Section IV.C 

for details on corrective action time 

frames. 

3. What Were the Key Issues Raised by 

Commenters on the Proposed GWR 

Sanitary Survey Requirements? 

The majority of commenters on the 

GWR proposal were supportive of a 

sanitary survey requirement for all 

GWSs. Most commenters supported the 

proposed frequencies of three years for 

CWSs and five years for NCWSs. Several 

commenters noted that some States 

conduct surveys at more frequent 

intervals than required in this rule. 

However, a few commenters suggested 

extending the frequency interval for 

CWSs, because they believed that CWSs 

would be less likely to have significant 

deficiencies. 

The Agency believes that frequent, 

comprehensive sanitary surveys are an 

important proactive public health 

measure and that the minimum 

frequencies of sanitary surveys under 

this rule balance public health 

protection with State implementation 

issues. This rule requirement is 

consistent with the frequency required 

for surface water systems under the 

IESWTR. The GWR provides flexibility 

in allowing States to perform more 

frequent sanitary surveys or to reduce 

the frequency for CWSs to five years if 

the CWS meets performance criteria 

(Section IV.A.1). States also have the 

flexibility to phase-in the evaluation of 

sanitary survey elements within the 

required frequency interval. The Agency 

believes that a frequency of three years 

for CWSs and five years for NCWSs, 

combined with flexibility on both 

timing and implementation, 

appropriately considers limited resource 

issues while advancing public health 

protection. 

EPA specifically requested comments 

on ‘‘grandfathering’’ sanitary surveys 

conducted under the TCR to satisfy the 

initial sanitary survey requirements of 

the GWR. The majority of comments 

favored allowing the use of sanitary 

surveys conducted under the TCR or 

existing State programs to meet the 

initial sanitary survey requirements of 

the GWR. These comments were largely 

based on an interest in reducing State 


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implementation burden and allowing 

States to transition their existing 

sanitary survey programs into programs 

and schedules that meet the 

requirements of the GWR. 

Because of the time frames laid out in 

the GWR for initial and repeat sanitary 

surveys, grandfathering sanitary surveys 

is not practicable. States must complete 

their initial CWS sanitary surveys six 

years after rule promulgation for CWSs 

and eight years for NCWSs. The 

deadline for completing the first round 

of sanitary surveys is longer than the 

minimum required sanitary survey 

frequency, so grandfathering would not 

result in a burden reduction for the 

State. For example, if a State were to 

grandfather a CWS sanitary survey from 

2005, they would be required to 

complete a second sanitary survey by 

2008 and a third by 2011, whereas a 

State that completed their first sanitary 

survey in 2009 would not be required to 

complete their second sanitary survey 

until 2012. As described in Section 

IV.A.2, the six to eight year time frame 

for initial sanitary surveys is based on 

several considerations. First, States need 

time to adopt the rule and obtain 

primacy (two to four years allowed 

under the SDWA at 1413(a)(1)). In 

addition, systems are given three years 

to comply with drinking water 

regulations by the SDWA at 

(1412(b)(10)). Finally, States need three 

to five years to complete the first cycle 

of sanitary surveys because there are 

many GWSs and States have limited 

resources. 

EPA believes that it is important to 

reduce State implementation burden 

and that information from existing 

sanitary surveys and other sources is an 

important resource. Thus, this rule 

allows States to reduce the frequency of 

sanitary surveys for CWSs that meet 

performance criteria (Section IV.A.1) at 

any time subsequent to the effective 

date of this rule from every three to 

every five years. This allows States to 

reduce the implementation burden of 

sanitary surveys based on information 

collected under the TCR and existing 

sanitary survey programs while still 

ensuring a minimum sanitary survey 

frequency of five years for both CWSs 

and NCWSs. Since a significant 

proportion of GWSs are small NCWSs 

and the GAO report found the greatest 

need for improvement in smaller 

systems, EPA believes that a reduction 

in frequency for NCWSs would not 

advance public health protection. EPA 

notes that surveys or elements of 

sanitary surveys conducted under the 

TCR or as part of site assessment or 

other State programs may be used to 

meet the GWR requirements if they meet 

the criteria specified in the GWR (i.e., if 

the minimum eight elements specified 

in the GWR are addressed at the 

specified GWR frequency). 

EPA received a number of comments 

on the 30-day time frame that States 

have to notify a system when a 

significant deficiency is identified in the 

sanitary survey. Some commenters 

noted that this requirement is consistent 

with current procedures; notice of 

significant deficiencies is often 

provided to a system much sooner. 

However, other commenters were 

concerned that this requirement placed 

an unnecessary deadline on the State 

and that current State policies and 

practices adequately address timely 

notification of systems with significant 

deficiencies. 

The Agency believes that timely 

notification of significant deficiencies is 

essential to the timely correction of 

those deficiencies and to the safety of 

drinking water. EPA believes requiring 

a 30-day maximum notification period 

in all States is reasonable, given the 

potential public health risk of 

significant deficiencies, and ensures 

equitable protection of public health 

across the nation. 

EPA also received comments on what 

constitutes a significant deficiency 

under the GWR. EPA proposed defining 

significant deficiencies as a defect in 

design, operation, or maintenance, or a 

failure or malfunction of the sources, 

treatment, storage, or distribution 

system that the State determines to be 

causing, or has the potential for causing, 

the introduction of contamination into 

the water delivered to consumers. 

Several commenters urged EPA to go 

beyond that definition and require 

States to specify a minimum list of 

significant deficiencies under each of 

the applicable eight sanitary survey 

components set out in the EPA/State 

Joint Guidance on Sanitary Surveys. 

EPA also received comments regarding 

specific examples of significant 

deficiencies in each applicable 

component. Section IV.A.1 of this 

preamble includes specific examples of 

some significant deficiencies provided 

by commenters. 

The Agency believes that to provide 

adequate public health protection, 

States must identify and require 

correction of all significant deficiencies. 

Also, EPA recognizes the importance for 

the State to include additional casespecific deficiencies. This rule states 

that significant deficiencies ‘‘include, 

but are not limited to, defects in design, 

operation, or maintenance, or a failure 

or malfunction of the sources, treatment, 

storage, or distribution system that the 

State determines to be causing, or has 

the potential for causing, the 

introduction of contamination into the 

water delivered to consumers.’’ The 

GWR requires each State, in its primacy 

application, to define and describe at 

least one specific significant deficiency 

in each of the eight sanitary survey 

elements. This enables States to work 

within their existing programs to define 

significant deficiencies as part of their 

primacy application and to define and 

describe significant deficiencies that 

may be unique to system size, type, 

location, or State requirements. EPA 

also recognizes that some systems may 

not have all eight components; for 

example, some TNCWSs may not have 

storage or require certified operators. 

EPA requested comment on having 

public involvement and/or meetings for 

certain PWSs to discuss the results of 

sanitary surveys and specifically what 

approaches might be practical and not 

overly burdensome to involve the public 

in working with water systems to 

address the results of sanitary surveys. 

Some commenters suggested publishing 

the results in the system’s Consumer 

Confidence Report (CCR) or reviewing 

the results at a public meeting. Others 

supported notifying the public that the 

results were available and how those 

results could be obtained. Some 

commenters noted that significant 

deficiencies would be corrected rapidly 

and that involving or informing the 

public after the correction might not be 

useful. One commenter suggested 

posting the results of surveys in a public 

place for non-community systems. 

EPA believes that adequate 

opportunities exist for customers to 

obtain information on the complete 

sanitary survey of their water supplier. 

Results of sanitary surveys and 

notification from the State to the water 

supplier of significant deficiencies 

would be available to the public upon 

request from the State or the water 

supplier. However, EPA also believes 

that the public served by the water 

system should be made aware of 

significant deficiencies found in 

sanitary surveys that remain 

uncorrected and be fully informed as to 

how and when those deficiencies will 

be corrected. This rule requires systems 

to notify customers of such significant 

deficiencies including the date and 

nature of the significant deficiency, the 

schedule for correction, any interim 

measures taken, and the progress to 

date. The State may require the system 

to notify customers of corrected 

significant deficiencies. This 

requirement is described further in 

Section IV.D of this preamble. 

EPA received comments suggesting 

that the sanitary survey provisions of 


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the TCR are sufficient to address viral 

and bacterial pathogens in GWSs and 

there is no need for sanitary surveys 

under the GWR. While EPA believes the 

TCR was a significant step forward for 

public health protection in 1989, the 

TCR does not require systems to correct 

significant deficiencies or require a 

minimum frequency of sanitary surveys 

for all systems. Thus, the GWR sanitary 

survey requirement better addresses the 

potential public health consequences of 

uncorrected significant deficiencies. 

B. Source Water Monitoring 

This rule requires ground water 

source monitoring as an essential 

element in its risk-targeted approach for 

identifying those GWSs with source 

water fecal contamination that need 

corrective action. Systems targeted for 

source water monitoring are those with 

an indication that they may be at risk for 

fecal contamination. Indicators of risk 

may come from total coliform 

monitoring, hydrogeologic sensitivity 

analyses, or other system-specific data 

and information. This rule requires 

triggered source water monitoring and 

provides States with the option to 

require assessment source water 

monitoring. Source water monitoring is 

not required for any GWS that is already 

providing at least 4-log treatment of 

viruses. 

A GWS with a distribution system 

TCR sample that tests positive for total 

coliform is required to conduct triggered 

source water monitoring to evaluate 

whether the total coliform presence in 

the distribution system is due to fecal 

contamination in the ground water 

source. Triggered source water 

monitoring provides a critical ongoing 

evaluation of GWSs. 

As a complement to the triggered 

source water monitoring provision, the 

GWR gives States the flexibility to 

require more comprehensive assessment 

source water monitoring on a case-bycase basis. The purpose of this optional 

assessment source water monitoring 

requirement is to target source water 

monitoring to systems that the State 

determines are at higher risk for fecal 

contamination. States are in the best 

position to assess which systems are at 

risk and would most benefit from source 

water monitoring. 

EPA believes that source water 

monitoring targeted at higher risk 

systems, namely triggered source water 

monitoring, in conjunction with 

optional assessment source water 

monitoring, will be effective in 

identifying systems with source water 

fecal contamination. With 

implementation of the follow-up 

corrective action requirements outlined 

in Section IV.C, these requirements will 

provide meaningful opportunities to 

reduce public health risk for a 

substantial number of people served by 

GWSs. 

BILLING CODE 6560–50–P 


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BILLING CODE 6560–50–C 


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1. What Are the Requirements of This 

Rule? 

a. Triggered source water monitoring. 

A GWS must conduct triggered source 

water monitoring within 24 hours of 

receiving notification that a routine 

sample collected in accordance with 

§ 141.21(a) (TCR) is total coliformpositive. A GWS must collect at least 

one ground water source sample from 

each ground water source (e.g., a well or 

spring) in use at the time the total 

coliform-positive sample was collected. 

Triggered source water monitoring is 

required unless: (1) The system provides 

at least 4-log treatment of viruses (using 

inactivation, removal, or a Stateapproved combination of 4-log virus 

inactivation and removal) before or at 

the first customer for each ground water 

source; (2) the system is notified that a 

positive sample collected in accordance 

with § 141.21(a) (TCR) has been 

invalidated under § 141.21(c); or (3) the 

cause of the total coliform-positive 

collected under § 141.21(a) directly 

relates to the distribution system as 

determined by the system according to 

State criteria or as determined by the 

State. The State may extend the 24-hour 

limit on a case-by-case basis if the State 

determines that the system cannot 

collect the ground water source water 

sample within 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. 

Systems are not required to conduct 

triggered source water monitoring if, 

according to State criteria or a State 

determination, the cause of the total 

coliform-positive sample collected 

under § 141.21(a) directly relates to the 

distribution system. If the GWS makes 

the decision according to State criteria, 

the GWS must document the decision in 

writing; if the decision is made by the 

State, the State must document the 

decision in writing. In the primacy 

application, the State must include 

criteria that will be used to determine 

that the cause of a total coliformpositive sample collected under 

§ 141.21(a) is directly related to the 

distribution system. 

If the State approves the use of E. coli 

as a fecal indicator for triggered source 

water monitoring, GWSs serving 1,000 

people or fewer may use a TCR repeat 

sample collected from a ground water 

source to simultaneously meet the 

requirements of § 141.21(b) and satisfy 

the GWR’s triggered source water 

monitoring requirements for that ground 

water source only. 

If approved by the State, systems with 

more than one ground water source may 

conduct triggered source water 

monitoring at a representative ground 

water source or sources. The State may 

require systems with more than one 

ground water source to submit for 

approval a triggered source water 

monitoring plan that the system will use 

for representative sampling. A triggered 

source water monitoring plan must 

identify ground water sources that are 

representative of each monitoring site in 

the system’s TCR sample siting plan. 

If any initial triggered source water 

sample is fecal indicator-positive, the 

system must collect five additional 

source water samples within 24 hours at 

that site, unless the State requires 

immediate corrective action to address 

contamination at that site. The samples 

must be tested for the same fecal 

indicator for which the initial source 

water sample tested positive. 

Ground water systems that purchase 

or sell finished drinking water (referred 

to as consecutive or wholesale systems, 

respectively) must comply with 

triggered source water monitoring 

provisions for their own sources. 

Consecutive and wholesale systems 

must also comply with other triggered 

source water monitoring requirements. 

A consecutive GWS that has a total 

coliform-positive sample collected 

under § 141.21(a) (TCR) must notify the 

wholesale system(s) within 24 hours of 

being notified of the total coliformpositive sample. If a wholesale GWS 

receives notice from a consecutive 

system it serves that a sample collected 

under § 141.21(a) (TCR) is total 

coliform-positive, the wholesale GWS 

must conduct triggered source water 

monitoring. If the sample is fecal 

indicator-positive, in addition to 

notifying its own customers, the 

wholesale GWS must notify all 

consecutive systems served by that 

ground water source. The consecutive 

system is responsible for providing any 

required public notice to the persons it 

serves. 

b. Assessment source water 

monitoring. The GWR provides States 

with the option to require systems to 

conduct assessment source water 

monitoring at any time and require 

systems to take corrective action. See 

Section IV.B.2.b for EPA’s 

recommendations of when assessment 

source water monitoring may be 

appropriate and how to structure the 

monitoring program. If the State chooses 

to use HSAs to determine the 

appropriateness of assessment source 

water monitoring, then systems must 

comply with State requests for 

information. 

c. Source water microbial indicators 

and analytical methods. A system that 

collects a source water sample to 

comply with this rule must analyze the 

sample for one of the three fecal 

indicators (E. coli, enterococci, or 

coliphage). Under this rule, GWSs must 

use one of seven specified analytical 

methods for E. coli, one of three 

methods specified for enterococci, or 

one of two methods specified for 

coliphage. The system is required to test 

at least a 100 mL sample volume for one 

of the three fecal indicators (E. coli, 

enterococci, or coliphage). All analyses 

must be conducted by a laboratory 

certified by the State or EPA. 

d. Invalidation of a fecal indicatorpositive ground water source sample. 

This rule allows systems to obtain 

written State invalidation of a fecal 

indicator-positive ground water source 

sample under either of the following 

conditions: (1) The system provides the 

State with written notice from the 

laboratory that improper sample 

analysis occurred; or (2) the State 

determines and documents in writing 

that there is substantial evidence that a 

fecal indicator-positive ground water 

source sample is due to a circumstance 

that does not reflect source water 

quality. If the State invalidates a fecal 

indicator-positive ground water source 

sample, the system must collect another 

ground water source sample within 24 

hours of being notified of the 

invalidation by the State and have it 

analyzed for the same fecal indicator. 

The State may extend the 24-hour limit 

on a case-by-case basis if it determines 

that the system cannot collect the 

ground water source water sample 

within 24 hours due to circumstances 

beyond the system’s control. In the case 

of an extension, the State must specify 

how much time the system has to 

collect the sample. 

2. What Is EPA’s Rationale for the GWR 

Source Water Monitoring Requirements? 

a. Triggered source water monitoring. 

i. Overall basis for provision. The 

GWR builds on the public health 

protection provided by the TCR by 

requiring systems to collect a ground 

water source sample when a TCR 

distribution system sample is total 

coliform-positive. Because a total 

coliform-positive sample in the 

distribution system may be caused by 

either a distribution system problem or 

source water contamination, the GWR 

triggered source water monitoring 

provision is necessary to distinguish 

between these two possible sources of 

fecal contamination. Thus, using the 

total coliform indicator is an efficient 

way to target higher risk systems where 

source water monitoring is warranted to 

investigate potential fecal 


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contamination. EPA believes that the 

GWR triggered source water monitoring 

provisions provide an effective means 

for improving public health protection. 

Total coliform monitoring in the 

distribution system is already required 

under the TCR. Thus, total coliform 

monitoring provides a no-cost screening 

for potential fecal contamination and 

pathogen occurrence at the source. Total 

coliform is a sensitive indicator for the 

presence of potential fecal 

contamination. In the occurrence 

studies evaluated for the GWR, wells 

that were monitored with high 

frequency for enterovirus and total 

coliforms detected both enterovirus and 

total coliform in their source water (i.e., 

Lieberman et al., 2002; Karim et al., 

2004; Wisconsin Department of Health, 

2000). Total coliform presence in source 

water can also be an indicator of recent 

surface and near surface water inflow to 

ground water, and pathogens originate 

at or near the surface. 

Triggered source water monitoring 

provides an ongoing evaluation of fecal 

contamination in the source water of all 

GWSs. Because well conditions and 

sources of fecal contamination can 

change over time, EPA believes that the 

ongoing continuous assessment 

provided by triggered source water 

monitoring is important. 

EPA believes that the triggered source 

water monitoring requirements of the 

GWR will effectively target higher risk 

GWSs. EPA’s analysis indicates that the 

triggered source water monitoring 

provisions will identify nearly 40 

percent of those wells with fecal 

contamination in their source water (See 

Chapter 6 of USEPA, 2006d). In 

addition, the wells with the highest 

frequencies of fecal contamination 

occurrence (which EPA believes are the 

highest risk wells from a public health 

perspective) will likely be captured first 

and wells with less frequent fecal 

contamination will be identified over 

time (USEPA, 2006d). 

ii. Reduced burden for small systems. 

Under the final GWR, a GWS serving 

1,000 people or fewer may use a TCR 

repeat sample to simultaneously meet 

requirements of the TCR and the GWR. 

Under the TCR, when a total coliform 

sample at a small system (serving 1,000 

people or fewer) is positive, the TCR 

requires the system to collect four repeat 

samples (one upstream and proximate to 

the initial total coliform-positive, one at 

the same location, one downstream and 

proximate to the original total coliformpositive, and one at another unspecified 

location). If the State approves the use 

of E. coli as a fecal indicator for ground 

water source monitoring, the GWR 

allows these small systems to meet the 

repeat monitoring requirements of 

§ 141.21(b) (TCR) by collecting their 

unspecified fourth repeat sample at the 

ground water source, thereby satisfying 

the GWR’s triggered source water 

monitoring requirements for that ground 

water source at the same time. The 

purpose of this provision is to mitigate 

the triggered fecal indicator source 

water monitoring burden for small 

systems and to improve upon the 

diagnostic value of repeat sampling 

under the TCR. 

The TCR repeat sample can be used 

for satisfying both the TCR repeat 

sample requirement and the initial 

source water fecal indicator under the 

GWR because the TCR methods and 

requirements provide the information 

necessary for complying with the GWR. 

If the repeat sample is negative for total 

coliform bacteria, then it is also negative 

for E. coli bacteria, and no further 

testing under the GWR is required. 

Under the TCR, if a repeat sample is 

positive for total coliform bacteria, the 

sample must then be further analyzed 

for the presence of either E. coli or fecal 

coliforms. If the sample is analyzed for 

E. coli, that will satisfy the GWR 

triggered monitoring requirements. 

Total coliform bacteria are a group of 

bacteria that include E. coli. The 

methods approved for the analysis of 

the water samples taken under the TCR 

can be found at § 141.21. Most of these 

methods are also approved for E. coli 

monitoring under the GWR (see Table 

IV–1 and § 141.402(c)). The analytical 

methods approved for use under the 

TCR listed in Table IV–1 may all be 

used for both total coliform detection, 

and most can be used for subsequent E. 

coli detection under the GWR. Two of 

the methods approved under the TCR 

(and listed with an asterix in Table IV–

1) can be used for total coliform 

detection only. In these two techniques 

(one of which is multiple tube 

fermentation and the other of which is 

membrane filtration using m-Endo 

medium), total coliforms are first 

cultured and confirmed. The laboratory 

analyst could then proceed to further 

analyze the total coliform-positive 

culture for either fecal coliforms or E. 

coli by simply choosing which 

subsequent medium to inoculate. 

Testing for fecal coliforms requires ECBroth while testing for E. coli requires 

use of EC-MUG broth. These two broths 

are similar, and require the same 

incubation temperatures and conditions. 

The only difference between the two 

media is the addition of the substrate 4- 

methylumbelliferone-b-D-glucuronide 

(MUG) to EC Broth, which is added to 

detect E. coli. Thus, if the State has 

approved E. coli as the fecal indicator 

for the GWR, the E. coli sample 

analyzed under the TCR will meet the 

GWR source water sample requirements. 

For the TCR repeat sample, a PWS must 

collect a 100 mL water sample and 

analyze it for total coliform bacteria, and 

further analyze it for a fecal indicator if 

it is total coliform-positive. This means 

that small systems (serving 1,000 people 

or fewer) have no additional sampling 

burden or costs from the GWR triggered 

source water monitoring requirement for 

an initial source water sample. 

TABLE IV–1.—METHODS APPROVED FOR DETECTION OF TOTAL COLIFORMS UNDER THE TCR AND FOR THE DETECTION

OF E. coli UNDER THE GWR (SEE § 141.402(C) FOR DETAILS REGARDING THESE METHODS) ** 

Method technology type Method 

Total 

coliforms 

detected 

E. coli 

detected 

TCR/GWR 

approval 

Multiple tube fermentation .................................... (LTB/P–A → BGLB)* ............................................ X .................... X 

EC–MUG .............................................................. .................... X X 

NA–MUG .............................................................. .................... X X 

Enzyme Substrate ................................................ Colilert/Colilert-18 ................................................. X X X 

Colisure ................................................................ X X X 

E* Colite Test ....................................................... X X X 

Membrane filtration ............................................... (m-Endo→LTB/BGLB)* ......................................... X .................... X 

EC–MUG .............................................................. .................... X X 

MI Agar ................................................................. X X X 


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TABLE IV–1.—METHODS APPROVED FOR DETECTION OF TOTAL COLIFORMS UNDER THE TCR AND FOR THE DETECTION

OF E. coli UNDER THE GWR (SEE § 141.402(C) FOR DETAILS REGARDING THESE METHODS) **—Continued 

Method technology type Method 

Total 

coliforms 

detected 

E. coli 

detected 

TCR/GWR 

approval 

m-ColiBlue 24 Test ............................................... X X X 

* Methods in parentheses detect total coliforms but not E. coli; if a total coliform sample is determined by this method in the source water sample, the analyst can choose the appropriate inoculation medium to analyze for E. coli. 

** If a total coliform sample is determined negative, no further testing under the GWR is required. If it is positive, the analyst can choose the 

appropriate E. coli method. 

iii. Provision for total coliformpositive result directly related to the 

distribution system. EPA recognizes that 

some systems may have a known 

problem in their distribution system 

that causes total coliform-positive 

results. In cases when the cause of a 

total coliform-positive result collected 

under § 141.21(a) is directly related to 

the distribution system according to 

State criteria or a State determination, 

systems are not required to collect 

ground water source samples to 

investigate potential fecal 

contamination in the source water. A 

State must include in its primacy 

application the criteria it will use to 

determine whether the cause of a total 

coliform-positive sample collected 

under § 141.21(a) is directly related to 

the distribution system. Systems will 

use these criteria to determine if the 

cause of a total coliform-positive sample 

is directly related to the distribution 

system. If the sample meets the criteria, 

the system is not required to do 

triggered source water monitoring. The 

State needs to determine these criteria 

as part of their primacy package so that 

GWSs that collect a total coliformpositive sample can decide whether 

they need to collect a source water 

sample(s) within the required 24 hour 

timeframe. The system must document 

this determination to the State within 30 

days so the State can ensure that the 

criteria are used correctly and that no 

potential public health risk from source 

water contamination has been 

overlooked. For issues not covered by 

the pre-determined criteria, the State 

can also make a determination that the 

cause of the total coliform-positive 

sample directly relates to the 

distribution system. 

iv. Basis for additional fecal indicator 

sampling following triggered source 

water monitoring. Numerous public 

comments on the proposal expressed 

concern that a corrective action should 

not be required based on one source 

water indicator-positive sample, as EPA 

proposed for triggered source water 

monitoring. The rationale for the 

proposal was that the likelihood of a 

false positive result occurring in both 

the distribution system sample and the 

fecal indicator source water sample 

would be small, and therefore it would 

be likely that the source water positive 

result was caused by true 

contamination. 

EPA has re-evaluated the use of repeat 

samples under the triggered source 

water monitoring provisions. Given that 

total coliform-positives in the 

distribution system can result from 

either distribution system or source 

water causes, a total coliform-positive in 

the distribution system does not 

necessarily predict fecal contamination 

of the source water. The possibility of 

false positives at the source and the 

associated potential for unnecessary 

follow-up corrective actions, even if 

relatively infrequent, prompted EPA to 

revise the final rule triggered source 

water monitoring provisions to require 

five additional samples following the 

initial positive sample before requiring 

corrective action (if one or more 

additional sample is positive), unless 

the State determines that immediate 

corrective action is necessary. In 

addition, the potential cost implications 

for a corrective action could be 

substantial, especially for small systems. 

EPA believes that in most cases these 

five additional samples should capture 

the fecal contamination event since the 

samples are taken within 24 hours. 

Discrete contamination releases, such as 

fecal septage, together with discrete 

precipitation events, become dispersed 

by hydrogeological processes over time. 

As a result, shorter duration events at 

the original contamination source may 

become longer duration (i.e., days or 

weeks) but more diluted events at the 

well. Thus, if an initial fecal indicatorpositive is detected at the well, that 

occurrence should be detectable again 

with additional samples within 24 

hours. Nevertheless, since the nature 

and source of contamination and the 

subsurface condition vary from site to 

site, prompt resampling within 24 hours 

is needed to capture events that may not 

be dispersed over time. Prompt 

resampling is particularly important in 

cases where the initial sampling event 

transpires at the tail-end of the well 

contamination event. 

b. Assessment source water 

monitoring. As a complement to the 

triggered source water monitoring 

provision, States have the option of 

requiring systems to conduct assessment 

source water monitoring. This flexible 

provision gives States the opportunity to 

target higher risk systems for additional 

source water monitoring and require 

corrective action, if necessary. EPA 

decided not to include requirements for 

assessment source water monitoring in 

the GWR for the reasons given in 

Section II.C of the preamble. Rather, 

EPA decided to give States flexibility to 

require assessment source water 

monitoring on a case-by-case basis. The 

purpose for this optional source water 

monitoring provision is to target 

systems that the States believe are at 

high risk from fecal contamination for a 

thorough evaluation of source water 

quality. Also, this allows lower risk 

GWSs to avoid unnecessary sampling 

(as determined by States). 

While EPA believes that triggered 

source water monitoring will capture 

many high risk systems, EPA also 

recognizes that the triggered source 

water monitoring provisions have 

limitations. Triggered source water 

monitoring under the TCR may not be 

timely (soon enough) or frequent 

enough to identify systems with 

intermittent fecal contamination. Also, 

coliforms are not a good indicator in 

certain aquifers in which viruses travel 

faster and further than bacteria. EPA 

believes that assessment source water 

monitoring can be an important 

complement to triggered source water 

monitoring because assessment source 

water monitoring provides a thorough 

examination of the source water at those 

systems that States deem to be at 

potentially high risk from fecal 

contamination. The flexibility of this 

requirement allows States to require 

assessment source water monitoring 

when and where it is needed most. 

Source water quality can change over 

time, so it is important for States to be 


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able to use assessment source water 

monitoring at any point in time. State 

programs work closely with PWSs on a 

daily basis and are thus knowledgeable 

about system specific conditions and 

issues. Therefore, EPA believes that the 

States are in the best position to assess 

for which systems the thorough 

evaluation of source water quality 

provided by assessment source water 

monitoring is most appropriate. EPA 

believes that assessment source water 

monitoring programs within the States’

discretion will be important to identify 

fecally contaminated systems for which 

corrective action is necessary to protect 

public health. EPA expects that States 

may use assessment source water 

monitoring for high-risk systems that are 

potentially susceptible to fecal 

contamination, especially where 

contamination is often present but 

intermittent enough to be missed by 

triggered source water monitoring. 

i. EPA’s recommendations for 

targeting systems for assessment source 

water monitoring. Information on a 

system’s potential susceptibility to fecal 

contamination is available to the States 

from many sources. For example, HSAs, 

source water assessments, wellhead 

protection plans, past microbial 

monitoring data particularly triggered 

source water monitoring results and 

frequency, and sanitary survey findings 

are available to States. In addition to 

these sources of information, EPA 

recommends that States consider the 

following risk factors in targeting 

susceptible systems for assessment 

source water monitoring: (1) High 

population density combined with onsite wastewater treatment systems, 

particularly those in aquifers with 

restricted geographic extent, such as 

barrier island sand aquifers; (2) aquifers 

in which viruses may travel faster and 

further than bacteria (e.g. alluvial or 

coastal plain sand aquifers); (3) shallow 

unconfined aquifers; (4) aquifers with 

thin or absent soil cover; (5) wells 

previously identified as having been 

fecally contaminated; and (6) sensitive 

aquifers. These factors are described in 

more detail below. 

Some localities may be at high risk 

because they serve large, sometimes 

seasonal, populations in areas without 

centralized sewage treatment and their 

aquifers are of restricted geographic 

extent, such as barrier island sand 

aquifers and Great Lakes island karst 

limestone aquifers. In these locations, 

the large population using septic tanks 

can overload the subsurface attenuation 

capability. Outbreaks have occurred in 

such resort communities (e.g., South 

Bass Island, OH, Ohio EPA, 2005, CDC, 

2005; Drummond Island, MI, Ground 

Water Education in Michigan, 1992; 

Chippewa County Health Department, 

unpublished report, 1992) due to 

overloaded septic tanks. 

Viruses travel faster and further than 

bacteria in some aquifers. In barrier 

island sand aquifers, traditional 

bacterial fecal indicator organisms such 

as total coliform and E. coli may not be 

mobile or sufficiently long-lived in the 

subsurface so as to adequately indicate 

the hazard from longer-lived and more 

mobile viral pathogens. Thus, a system 

could have fecal contamination and yet 

not be triggered for source water 

monitoring by TCR monitoring results. 

In such cases, assessment source water 

monitoring using coliphage would be 

the best means for identifying fecal 

contaminants because coliphage is a 

viral fecal indicator and thus is more 

likely to reach the well than bacterial 

indicators such as E. coli and 

enterococci. 

Shallow, unconfined aquifers are high 

risk because the vertical flow path to the 

aquifer is short and unrestricted by 

barriers. Pathogens originate at or near 

the surface and may be more likely to 

contaminate well water when the travel 

time for infiltrating precipitation is 

short and unhindered. 

Wells previously identified as having 

been fecally contaminated should be 

considered high risk because such fecal 

contamination can reoccur. For 

example, wells in this category may 

include wells associated with a previous 

acute TCR violation related to the 

source or those wells that had an initial 

fecal indicator-positive triggered source 

water sample but had five negative 

additional samples (especially wells 

with highly variable source water such 

as those in sensitive aquifers). Wells 

with highly variable source water may 

be subject to occasional short-lived 

contamination events. Thus it is 

possible to have a true fecal indicatorpositive sample followed by true fecal 

indicator-negative samples. Exposures 

during intermittent contamination 

events can be significant, so it is 

important to identify such high-risk 

systems. This is best accomplished 

through a thorough source water 

evaluation program such as assessment 

source water monitoring. 

Sensitive aquifers (e.g., karst, 

fractured bedrock, or gravel) can have 

fast (kilometers per day) and direct 

ground water flow through large 

interconnected openings (void spaces) 

during which very little pathogen 

attenuation may occur (either by natural 

inactivation or attachment) between a 

fecal source of contamination and the 

well. Consequently, sensitive aquifers 

are efficient at transmitting pathogens, if 

present, from surface and near-surface 

sources to PWS wells. Ground water 

flow in non-sensitive aquifers (such as 

a sand aquifer) tends to be very slow 

(feet per day), takes a very indirect path 

around a very large number of sand 

grains, and provides more opportunities 

for pathogen die-off and attachment. 

The faster flow travel time within a 

sensitive, as opposed to a non-sensitive, 

aquifer enables a much larger 

contaminant plume from potential fecal 

contamination events (e.g., failing septic 

systems or a leaking sewer line). 

When ground water flow is fast and 

direct as in sensitive aquifers, 

contamination can be short and 

intermittent and difficult to capture. 

The frequency by which triggered 

source water monitoring is prompted 

via detection of a total coliform-positive 

sample under the TCR may not be 

timely enough to recognize that a well 

is at risk from fecal contamination. First, 

TCR monitoring at some systems is 

infrequent. Small systems conduct 

limited total coliform monitoring in the 

distribution system under the TCR and 

thus intermittent fecal contamination of 

the source could be missed (i.e., these 

systems may conduct triggered source 

water monitoring infrequently under the 

GWR). Second, the lag time between an 

initial fecal contamination event and 

total coliform presence in the 

distribution system may be several days. 

Thus, if the fecal contamination event is 

of short duration, triggered source water 

monitoring may not capture the initial 

event. 

Some of the largest reported 

waterborne disease outbreaks in GWSs 

have occurred among systems drawing 

water from sensitive aquifers. Table IV–

2 provides a summary of recent 

outbreaks reported in sensitive aquifers. 

The number and nature of recent 

waterborne outbreaks shown in the table 

suggest that additional measures are 

necessary to protect those consuming 

water from PWS wells in sensitive 

aquifers. Noteworthy among these 

outbreaks is the South Bass Island, Ohio 

outbreak. After that outbreak in 2004, 16 

of the 18 TNCWSs on South Bass Island 

tested positive for fecal indicator 

organisms (Ohio EPA, 2005; CDC, 2005). 

Thus, the monitoring protections offered 

by the TCR were inadequate to protect 

the community from experiencing a 

waterborne disease outbreak in this 

karst limestone aquifer. 


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TABLE IV–2.—RECENT WATERBORNE DISEASE OUTBREAKS (PWSS) REPORTED IN KARST LIMESTONE AND FRACTURED

BEDROCK (SENSITIVE) AQUIFERS

Location Reference Number of illnesses/agent 

Outbreaks in Karst Limestone Aquifers 

South Bass Island, OH ....................................... Ohio EPA, 2005; CDC, 2005 ........................... 1,450/Norovirus, Campylobacter, Salmonella. 

Walkerton, Ontario, Canada ............................... Health Canada, 2000; Bopp et al., 2003; Worthington et al., 2002.1,346 cases/E. coli O157:H7 (+ 

Campylobacter); 7 deaths. 

Brushy Creek, TX ............................................... Bergmire-Sweat et al., 1999; Lee et al., 2001 1,300–1,500 cases/Cryptosporidium (not recognized as GWUDI until after the outbreak). 

Reading, PA ....................................................... Moore et al., 1993 ............................................ 551 cases/Cryptosporidium (not recognized 

as GWUDI until after the outbreak). 

Racine, MO ........................................................ MO Department of Health, unpublished report, 

1992.

28 cases/HAV. 

Drummond Island, MI ......................................... Ground Water Education in Michigan, 1992; 

Chippewa County Health Department, unpublished report, 1992.

39 cases/Unknown. 

Cabool, MO ........................................................ Swerdlow et al., 1992 ...................................... 243 cases/E. coli O157:H7; 4 deaths. 

Outbreaks in Fractured Bedrock Aquifers 

Big Horn Lodge, WY .......................................... Anderson et al., 2003 ...................................... 35/Norovirus. 

Atlantic City, WY ................................................ Parshionikar et al., 2003 .................................. 84/Norovirus. 

Couer d’Alene, ID ............................................... Rice et al., 1999 ............................................... 117/Arcobacter butzleri. 

Island Park, ID .................................................... CDC, 1996 ....................................................... 82 cases/Shigella. 

Northern AZ ........................................................ Lawson et al., 1991 ......................................... 900 cases/Norwalk virus. 

Where the type of aquifer is unknown, 

EPA recommends that the State conduct 

an HSA to identify sensitive aquifers 

and to determine if assessment source 

water monitoring is appropriate. In 

sensitive aquifers, more frequent 

monitoring could more quickly identify 

wells with fecal contamination. EPA 

recommends that States use HSAs as a 

tool to determine at-risk GWSs, and EPA 

intends to provide guidance on how to 

conduct HSAs. 

Several means can be used to evaluate 

wells without site-specific inspections 

to determine if they are located in 

sensitive hydrogeologic settings. For 

example, hydrogeologic data are 

available from published and 

unpublished materials such as maps, 

reports, and well logs. As discussed in 

more detail in the GWR proposal 

(USEPA, 2000a), the United States 

Geologic Survey (USGS), U.S. 

Department of Agriculture’s Natural 

Resource Conservation Service, USGS 

Earth Resources Observation System 

Data Center, the EPA Source Water 

Assessment Program and Wellhead 

Protection Program, State geological 

surveys, and universities have 

substantial amounts of regional sitespecific information. States can also 

base assessments on available 

information about the character of the 

regional geology, regional maps, and 

rock outcrop studies. 

In summary, HSAs can be an effective 

screening tool for identifying GWSs 

susceptible to fecal contamination for 

which assessment source water 

monitoring would be appropriate and 

beneficial. 

ii. EPA’s recommendations for 

assessment source water monitoring 

program. EPA recommends that States 

require systems that are conducting 

assessment source water monitoring to 

collect a total of 12 ground water source 

samples that represent each month the 

system provides ground water to the 

public. The 12 sample minimum is 

based on several considerations: 

• The sampling frequency should 

consider diminishing returns on the 

effectiveness of identifying fecally 

contaminated wells; 

• The sampling should be frequent 

enough to capture a range of conditions 

that can vary over the course of a year; 

and 

• The sampling frequency should 

consider ground water source 

monitoring costs incurred by GWSs. 

EPA estimates that about 26 percent 

of all wells have E. coli occurrence at 

some time, but the periods of such 

contamination may be very short and 

thus difficult to detect by the triggered 

source water monitoring requirements 

for some systems. With 12 assessment 

ground water source samples alone (i.e., 

absent any triggered source water 

monitoring), at least half of the wells 

with sometime E. coli contamination 

would be expected to test positive at 

least once. Table IV–3 shows that as 

sampling frequency increases above 12 

samples, the ability to identify 

additional wells that have E. coli 

presence rises more slowly and that 

relatively smaller percentages of 

additional wells with E. coli are 

identified per additional sample assay. 

This table shows that the sampling with 

12 assays (i.e., tests) captures 52 percent 

of the wells with sometime E. coli 

contamination, but sampling with 24 

assays only captures an additional nine 

percent. 

TABLE IV–3.—NUMBER OF E. coli ASSAYS AND PERCENT CONTAMINATED

WELLS IDENTIFIED

Number of assays 

(N) 

Fraction 

identified 

(Mean in 

percent) 

3 ................................................ 28 

6 ................................................ 40 

12 .............................................. 52 

24 .............................................. 61 

36 .............................................. 65 

48 .............................................. 68 

60 .............................................. 70 

The wells that the assessment source 

water monitoring identifies as 

contaminated tend to be those that have 

frequent occurrence of E. coli. Those 

wells with highly infrequent E. coli 

occurrence would be difficult to capture 

even with a significant increase in 

number of samples because the overall 

period of time of indicator occurrence is 

small relative to when the sampling 

occurs. 

Considering the costs of additional 

assays (beyond 12 assessment ground 

water source samples) and the reduced 

efficiency at identifying additional 


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contaminated wells, EPA believes that 

12 assays are appropriate. 

EPA recommends that the assessment 

source water monitoring program be 

representative of the system’s typical 

operation. Using a minimum of 12 

samples for assessment source water 

monitoring would also ensure sampling 

for each month that most systems are in 

operation, which is important because 

of the impact that seasonal events can 

have on contamination (e.g., heavy rain 

events). For seasonal systems, EPA 

recommends equally distributing 12 

samples or sampling during consecutive 

years. 

The option under the GWR for States 

to specify assessment source water 

monitoring requirements allows States 

to initiate a more thorough source water 

monitoring program than that resulting 

from the triggered source water 

monitoring provisions alone on a caseby-case basis, as deemed appropriate. 

For example, a sanitary survey may 

indicate that there has been a recent 

development of added source water 

vulnerability that would warrant 

additional source water sampling to 

discern whether there is potential fecal 

contamination beyond that which 

would be triggered through the TCR. 

Additionally, belated recognition of the 

significance of karst limestone after an 

outbreak (e.g., Walkerton, Ontario; 

South Bass Island, Ohio) suggests that 

States may choose to specify 

identification of sensitive aquifers 

combined with assessment source water 

monitoring to enhance multi-barrier 

protection. 

c. Source Water Samples 

i. Source water microbial indicators. 

The final GWR requires GWSs that are 

performing triggered source water 

monitoring to monitor their ground 

water source(s) for one of three fecal 

indicators (E. coli, enterococci, or 

coliphage). The State must specify 

which fecal indicator the GWSs must 

test for in their ground water source(s). 

EPA recommends that States use these 

same requirements for GWSs performing 

assessment source water monitoring. 

In this rule, EPA is authorizing the 

use of E. coli and enterococci as 

bacterial indicators of fecal 

contamination. Both of these indicators 

are closely associated with fresh fecal 

contamination and are found in high 

concentrations in sewage and septage. 

Approved analytical methods for these 

indicators are commercially available, 

simple, reliable, and inexpensive. E. coli 

is monitored under the TCR and 

therefore GWSs are familiar with its 

measurement and interpretation. 

Enterococci are recommended as one of 

the indicators for fecally contaminated 

recreational waters and therefore have 

widespread use. Enterococci may be a 

more sensitive fecal indicator than E. 

coli in certain aquifer settings and 

therefore may be the preferred indicator 

in such locations. 

EPA is also authorizing the use of 

coliphage as a viral indicator of fecal 

contamination. Coliphage are viruses 

that infect the bacterium E. coli. They 

are closely associated with fecal 

contamination because they do not tend 

to infect other non-fecal bacteria. 

Because they are viruses, their stability 

and transport through soil and certain 

aquifer types are similar to the fate and 

transport of pathogenic viruses. There 

are two categories of coliphage—somatic 

coliphage and male-specific coliphage. 

Local knowledge of hydrogeological 

conditions may inform which of the 

indicators may be most effective for 

identifying fecal contamination 

(USEPA, 2006b). EPA plans to publish 

a guidance manual to help to inform 

such decisions. This rule gives States 

the discretion to specify use of E. coli, 

enterococci, or one of the coliphage 

types to monitor for potential presence 

of fecal contamination in ground water 

sources. 

ii. Basis for requiring one versus more 

than one fecal indicator. EPA’s Science 

Advisory Board (SAB) and the National 

Drinking Water Advisory Council 

(NDWAC) recommended that EPA 

require monitoring for coliphage and 

either E. coli or enterococci for source 

water monitoring. The reasons stated by 

SAB and NDWAC were that (1) Ground 

water occurrence data show that no 

single indicator can fully capture all 

fecal contamination, (2) coliphage is an 

important indicator of enteric virus 

contamination in terms of transport and 

survival characteristics, and (3) a 

significant portion of waterborne 

disease risk is associated with exposure 

to pathogenic viruses in ground water 

sources utilized by a subset of PWSs 

(USEPA, 2000h and 2000i). 

EPA had insufficient data to evaluate 

the effectiveness, on a national level, of 

using both coliphage and either E. coli 

or enterococci as source water 

indicators of fecal contamination. While 

coliphage data is available for many of 

the occurrence studies used to estimate 

national occurrence for E. coli, the 

methods used to measure coliphage are 

often based on high volume analysis 

and a variety of methods different than 

those specified under the final GWR. 

Thus, EPA could not determine whether 

SAB’s proposal would provide 

additional effectiveness. 

EPA is concerned with the potential 

increase in sampling burden relative to 

the additional number of fecally 

contaminated wells that would be 

identified using two indicators 

compared to the use of one indicator. 

The analytical cost for coliphage (viral 

fecal indicator) monitoring is estimated 

to be about two to three times the cost 

for bacterial fecal indicator monitoring. 

Therefore, requiring a GWS to monitor 

for both bacterial and viral fecal 

indicators would more than double the 

analytical costs for GWSs. Based on the 

limited data available, EPA believes that 

it is not reasonable to require all GWSs 

to monitor for both a bacterial and a 

coliphage indicator in their source 

water. 

EPA believes that the most 

appropriate indicator may vary from 

State to State or site to site. This may 

be due to regional or site-specific 

differences or other reasons that may be 

identified by the State. EPA intends to 

provide guidance on how to determine 

which indicator may be most 

appropriate to use. 

For the reasons discussed above, EPA 

believes that the use of a single fecal 

indicator (E. coli, enterococci, or 

coliphage) provides a cost-effective 

means for identifying fecally 

contaminated wells and protecting 

public health. 

iii. Sample volume and analytical 

methods. This rule requires GWSs 

performing triggered source water 

monitoring to collect and test at least a 

100 mL sample volume. EPA 

recommends that States use this 

requirement for assessment source water 

monitoring. The final GWR requires a 

minimum sample volume of 100 mL 

because most utilities are familiar with 

this sample volume for bacterial 

indicator analysis, and the two EPA 

approved coliphage methods include at 

least this volume in their procedures. 

EPA believes that specifying a higher 

minimum sample volume would unduly 

increase the cost per sample (especially 

due to shipping). Furthermore, if a 

higher minimum sample volume were 

specified in the GWR, small systems 

would not be able to realize the 

considerable monitoring cost savings 

from use of TCR repeat sampling 

previously discussed in Section 

IV.B.2.a.ii. 

With regard to analytical methods 

used for ground water source 

monitoring under this rule, four of the 

seven methods for the analysis of E. coli 

in source waters allowed under this rule 

are consensus methods described in 

Standard Methods for the Examination 

of Water and Wastewater (20th editions) 

(APHA, 1998). The three E. coli methods 

that are not consensus methods are as 

follows: MI agar (a membrane filter 

method), the ColiBlue 24 test (a 


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membrane filter method), and the 

E*Colite test (a defined dehydrated 

medium to which water is added). EPA 

has already evaluated and approved 

these three methods for use under the 

TCR. In the proposed rule § 141.403(d), 

footnotes 4 and 5, the use of MI agar 

with Membrane Filtration Method was 

allowed. Membrane Filtration Method is 

an EPA-approved drinking water 

method, as indicated in footnote 4, 

while footnote 5 cites a manuscript 

describing MI agar. Subsequent to the 

proposal of the GWR, EPA developed 

EPA method 1604 ‘‘Total Coliforms and 

Escherichia coli in Water by Membrane 

Filtration Using a Simultaneous 

Detection Technique (MI Medium)’’

(USEPA, 2002c). This method was 

created to ensure consistency with other 

EPA microbiological methods and was 

promulgated under the Clean Water Act 

for use in ambient water monitoring July 

21, 2003 (68 FR 43272–43283) at 40 CFR 

136.3, Table 1A, footnote 22. Method 

1604 is equivalent to both the 

manuscript and the EPA-approved 

Membrane Filtration Method, and EPA 

has indicated in Section 5.4.2.1.3 of the 

Manual for the Certification of 

Laboratories Analyzing Drinking Water 

(USEPA, 2005b) that Method 1604 is 

identical. EPA Method 1604 is available 

on the EPA Web site at http:// 

www.epa.gov/microbes. This rule allows 

EPA Method 1604 because the Agency 

believes it will be easily available to the 

public. 

Three enterococci methods for the 

analysis of source water are allowed 

under this rule; two of these are 

consensus methods in Standard 

Methods (APHA, 1998), and the third 

(Enterolert) was published in a peerreviewed journal article (Budnick et al., 

1996). The description for each of the E. 

coli and enterococci methods explicitly 

states that the method is appropriate for 

fresh waters or drinking waters. The 

proposed rule, § 141.403(d), footnote 8 

of the table, also proposed to allow EPA 

Method 1600 (USEPA, 1997d) as an 

approved variation of one of the two 

consensus methods, Standard Method 

9230C, for enterococci. However, 

subsequent to the proposal of the GWR, 

EPA slightly modified EPA Method 

1600 (USEPA, 2002a) and promulgated 

the new version under the Clean Water 

Act on July 21, 2003 (68 FR 43272–

43283), at § 136.3, Table 1A, Footnote 

25. The revised method replaced the 

1997 version on the EPA Web site 

(http://www.epa.gov/microbes). EPA 

does not regard the changes in the 

newer version of Method 1600 as 

substantive and, aside from changes in 

format, contact, and grammar, has 

indicated the differences between the 

two versions in a memo dated March 12, 

2004 that is included in the Water 

Docket for the GWR. This rule allows 

the more recent version of EPA Method 

1600 because, and in addition to a few 

updates and more clarifications, the 

Agency believes that it will be much 

more easily available to the public. 

EPA proposed to allow, and continues 

to allow under this rule, the use of the 

two coliphage methods, U.S. EPA 

Methods 1601 and 1602 (USEPA, 2001a, 

2001b), for source water testing—a new 

two-step enrichment method (Method 

1601) and a single-agar layer method 

(Method 1602) recently optimized for 

ground water samples. These methods 

have been round-robin tested (USEPA, 

2003a and b) and the Agency has also 

conducted performance studies, using 

10 laboratories, on the two proposed 

methods. A full report of each of the two 

performance studies is available in the 

Water Docket. They are entitled (1) 

Results of the Interlaboratory Validation 

of EPA Method 1601 for Presence/ 

Absence of Male-specific (F+) and 

Somatic Coliphage in Water by TwoStep Enrichment (USEPA, 2003a), and 

(2) Results of the Interlaboratory 

Validation of EPA Method 1602 for 

Enumeration of Male-specific (F+) and 

Somatic Coliphage in Water by Single 

Agar Layer (SAL) (USEPA, 2003b). 

With regard to method cost, EPA 

queried seven laboratories that 

participated in the round-robin 

performance testing of the proposed 

coliphage tests. Based upon this survey, 

EPA estimates that the coliphage tests 

(not including sampling or shipping 

costs) will cost about $59–$65 per test 

(DynCorp, 2000). This compares to 

about $20–25 for bacterial indicators. 

iv. Invalidation of a fecal indicatorpositive ground water source sample. 

This rule allows the State to invalidate 

a fecal indicator-positive triggered 

source water monitoring sample if the 

system provides the State with written 

notice from the laboratory that improper 

sample analysis occurred, or if the State 

determines and documents in writing 

that there is substantial evidence that a 

fecal indicator-positive ground water 

source sample is not related to source 

water quality. These provisions are 

consistent with the sample invalidation 

criteria under the TCR and provide a 

necessary flexibility to States. 

3. What Were the Key Issues Raised by 

Commenters on the Proposed GWR 

Source Water Monitoring Requirements? 

a. Triggered source water monitoring. 

i. Use of total coliform-positive result 

as a trigger for source water fecal 

indicator monitoring. Many commenters 

maintained that a single total coliformpositive sample was too sensitive of a 

trigger to prompt a requirement to 

collect a ground water source sample. 

Among their reasons were that a single 

total coliform-positive sample in the 

distribution system is not necessarily 

linked to any source water problem or 

even a public health risk. Some argued 

that other triggers were more suitable, 

such as an acute MCL violation or a 

non-acute MCL violation under the 

TCR. A number of commenters were 

opposed to triggered source water 

monitoring altogether. 

As discussed in Section IV.B.2, EPA 

believes that triggered source water 

monitoring is an important requirement 

to protect public health. In response to 

commenters’ concerns that a single total 

coliform-positive sample in the 

distribution system is not necessarily 

linked to any source water problem, 

EPA has added language in the final 

GWR that allows States to determine 

that the cause of a total coliformpositive collected under § 141.21(a) is 

directly related to the distribution 

system and will thus not be a trigger for 

fecal indicator source water monitoring. 

Because the time available to make the 

determination is short, the State may 

develop criteria for systems to use to 

make the determination, which would 

be followed by a report to the State. 

Unless clearly indicated otherwise, 

EPA believes that a total coliformpositive sample in the distribution 

system is an indication of potential 

microbial contamination of the GWS 

that may have originated from the 

ground water source. This is a 

potentially serious public health risk 

that warrants follow-up action. 

EPA believes that basing triggered 

source water monitoring on TCR MCL 

violations would not be sensitive 

enough to identify the majority of fecal 

contamination events at the source. EPA 

estimated that the percentage of fecally 

contaminated wells that would be 

identified under such a provision would 

be an order of magnitude less than 

under the requirements of the final rule. 

Consequently, EPA believes that such a 

requirement would not be adequately 

protective. 

ii. Consecutive system and wholesale 

system requirements. EPA requested 

comment on which GWR requirements 

should apply to consecutive systems 

and specifically who should be 

responsible for triggered source water 

monitoring after a total coliformpositive sample is found in the 

consecutive system’s distribution 

system. Many commenters 

recommended that the seller (or 

wholesale) system be responsible for 


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ground water source monitoring, not the 

consecutive system. Others suggested 

the State should decide which system 

should take the ground water source 

sample. In addition, some commenters 

maintained that the buyer (or 

consecutive) system should not be 

responsible for meeting the treatment 

technique requirements (e.g., 4-log 

treatment) for sources. 

EPA infers that some commenters 

based their comments on an 

understanding that consecutive systems 

were only systems that received all their 

finished water from a wholesale system, 

although that is not always correct. 

Since the GWR proposal, EPA defined 

‘‘consecutive system’’ and ‘‘wholesale 

system’’ in § 141.2 in the Stage 2 

Disinfectants and Disinfection 

Byproducts Rule (DBPR) (71 FR 388, 

January 4, 2006) (USEPA, 2006g). In 

those definitions, which apply to all 

requirements in 40 CFR Part 141 

(including the GWR), EPA specified and 

clarified that consecutive systems 

include both systems that receive all of 

their finished water from one or more 

wholesale systems and systems that 

receive some of their finished water 

from one or more wholesale systems 

(with the balance coming from a source 

or sources operated and treated, as 

necessary, by the consecutive system). 

The Agency has added requirements 

to clarify the responsibilities of 

consecutive and wholesale systems in 

response to comments received, and to 

facilitate implementation and 

compliance. EPA believes that public 

health and risk concerns underlying the 

requirement for triggered ground water 

source monitoring after a total coliformpositive sample are equally applicable 

to consecutive systems and wholesale 

systems. EPA also believes that the 

system that operates the ground water 

source should be responsible for any 

required triggered or assessment source 

water monitoring and any required 

corrective actions, including 4-log 

treatment installation, operation, and 

compliance monitoring. 

Without treatment, water quality 

problems in the wholesale system will 

remain in the water delivered to the 

consecutive system and thus water 

quality problems in the consecutive 

system may be related to problems in 

the wholesale system (even if the 

wholesale system has not identified the 

problems). Therefore, in the GWR, 

specific triggered source water 

monitoring requirements apply to 

consecutive systems and wholesale 

systems (as explained in the following 

paragraphs) unless the cause of the total 

coliform-positive collected under 

§ 141.21(a) directly relates to the 

distribution system as determined by 

the system according to State criteria, or 

as determined by the State. 

Consecutive systems that have a total 

coliform-positive sample must notify 

the wholesale system(s) within 24 hours 

of being notified of the total coliformpositive sample so that the wholesale 

system(s) can conduct triggered source 

water monitoring, since the wholesale 

system’s source water may be the cause. 

Also, a consecutive system with its own 

ground water source(s) that has a total 

coliform-positive sample under the TCR 

must conduct triggered source water 

monitoring of its own sources, just like 

any other GWS that must conduct 

triggered source water monitoring. A 

consecutive system that has no source of 

its own (i.e., it receives all of its finished 

water from one or more wholesale 

systems) is not required to conduct 

triggered source water monitoring, since 

it has no source water. Only systems 

that produce finished ground water (i.e., 

have their own sources) are required to 

conduct triggered source water 

monitoring. 

Consecutive systems are required to 

comply with the GWR treatment 

technique requirements only in cases of 

contamination in the consecutive 

system’s own ground water source. 

Consecutive systems are not required to 

comply with GWR treatment technique 

requirements if a fecal indicator-positive 

is detected only in the wholesale 

system’s ground water source; only the 

system with the source contamination 

must comply with the GWR treatment 

technique requirements (in this case, the 

wholesale system). Similarly, wholesale 

systems are not required to comply with 

GWR treatment technique requirements 

if a fecal indicator-positive is detected 

only in the consecutive system’s ground 

water source and not in the wholesale 

system’s source; again, only the system 

with the source contamination must 

comply with the GWR treatment 

technique requirements (in this case, the 

consecutive system). 

iii. Repeat samples to confirm initial 

fecal indicator-positive. Several 

commenters raised concerns that a 

single positive fecal indicator source 

water sample should not result in a 

corrective action because the indicator 

sample result may be a false positive. 

The same commenters recommended 

that repeat samples be taken to confirm 

the initial result before requiring 

corrective action. In response to 

commenters and based on the 

discussion in Section IV.B.2, unless the 

State determines that corrective action 

should be taken following an initial 

fecal indicator-positive source water 

sample, the final GWR requires that the 

GWS take five additional samples, and 

that only if one of those samples is fecal 

indicator-positive is corrective action 

required. This prevents systems from 

incurring costs from the application of 

unnecessary corrective actions. The 

State may require the system to take 

corrective action after the first fecal 

indicator-positive source water sample. 

EPA believes that five additional 

samples following a positive triggered 

source water monitoring sample 

provides a reasonable balance between 

ensuring that corrective actions are 

warranted, avoiding excessive resampling costs, and avoiding an 

incorrect conclusion that the initial 

positive was false (i.e., avoiding a 

situation in which corrective action is 

needed but not taken because of false resample results). EPA believes that 

multiple samples, rather than one, are 

needed to ensure that corrective action 

is taken when necessary. EPA proposed 

using five repeat samples under the 

routine monitoring provisions (65 FR 

30230) (USEPA, 2000a). Commenters 

wanted EPA to use repeat samples for 

the triggered monitoring provisions also 

because they were concerned about false 

positives and systems taking 

unnecessary corrective actions. They 

recommended four or five repeat 

samples for triggered monitoring. In 

response to comments, the final GWR 

requires five repeat samples under the 

triggered source water monitoring 

provisions. 

iv. Source water monitoring burden. 

In the final GWR, EPA has reduced the 

sampling burden for small systems 

serving 1,000 people or fewer. Under 

the TCR, a system that collects one or 

fewer routine samples per month 

(systems that serve 1,000 people or 

fewer) with a total coliform-positive 

sample (that has not been invalidated) is 

already required to collect a set of four 

repeat samples in the distribution 

system within 24 hours of the total 

coliform-positive sample. Under this 

rule, one of the four repeat samples 

required under the TCR may be used to 

satisfy the GWR source water 

monitoring requirements if the sample 

is taken at a ground water source and 

only if the State approves the use of E. 

coli as a fecal indicator. 

In addition, the final rule reduces 

sampling burden for systems with more 

than one well (e.g., many large systems). 

Based on comments received, the GWR 

provides flexibility for systems with 

more than one well. The triggered 

source water monitoring provision 

allows systems with more than one 

ground water source, upon State 

approval, to sample a representative 

ground water source (or sources) 


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following any total coliform-positive 

sample. The State may require systems 

with more than one ground water source 

to submit for approval a triggered source 

water monitoring plan that the system 

will use for representative sampling. 

EPA believes that this alternative can be 

as protective of public health as 

monitoring all wellheads, provided that 

the chosen wells are truly representative 

of all wellheads. In addition, for 

situations where a particular sample site 

is inaccessible, the State may identify an 

alternate sampling site that is 

representative of the water quality of the 

ground water at the inaccessible sample 

site. 

b. Routine Monitoring. Many 

comments regarding routine source 

water monitoring were related to HSAs. 

Many commenters suggested State 

discretion on which systems should be 

considered sensitive and thus be 

required to do routine monitoring. 

EPA has taken public comments on 

routine monitoring and HSAs into 

consideration, as discussed in Section 

II.C. The final GWR provides State the 

option to require assessment source 

water monitoring at GWSs that the State 

determines to be most susceptible to 

fecal contamination. EPA believes that 

this optional provision is an important 

tool that should be used by States to 

protect public health. 

EPA recommends HSAs as one way to 

identify higher risk systems for which 

assessment source water monitoring 

would be beneficial and appropriate. 

Based on comments received, the final 

GWR does not require HSAs or 

assessment source water monitoring, 

except as provided by the State (see 

Section II.C). 

c. Source water microbial indicators 

and analytical methods. This rule 

allows a State to direct a system to use 

E. coli, enterococci, or coliphage for 

ground water source monitoring. 

Regarding coliphage testing, one major 

issue raised by commenters pertained to 

the performance of the two proposed 

coliphage methods. Many commenters 

questioned method reliability, 

specificity, sensitivity, false-positive 

rates, and lack of comprehensive field 

testing. They were also concerned about 

analytical costs and the availability of 

laboratory capacity. As explained 

earlier, the Agency believes that the 

results of performance studies indicate 

that both methods have been validated 

for reliable use in drinking water 

contexts. As discussed in Section 

IV.B.2, EPA recognizes that the 

analytical costs for coliphage testing are 

more than double the cost for bacterial 

(E. coli and enterococci) analyses. 

Therefore, EPA believes that many 

States will specify a bacterial fecal 

indicator for GWR source water 

monitoring based on cost. However, the 

Agency allows coliphage testing in this 

rule due to awareness that some 

laboratories are proficient in coliphage 

analysis and that this indicator may be 

preferred over others, depending on 

site-specific knowledge. While EPA 

recognizes that limited laboratory 

capacity for coliphage testing may be an 

issue, this rule provides States with 

discretion in determining which fecal 

indicators (E. coli, enterococci, or 

coliphage) will be used. EPA expects 

that one of the factors that States may 

use to decide which fecal indicator to 

specify is laboratory capacity. 

C. Corrective Action Treatment 

Techniques for Systems With Significant 

Deficiencies or Source Water Fecal 

Contamination 

The final GWR provides for regular, 

comprehensive sanitary surveys of all 

GWSs and triggered source water and 

optional assessment source water 

monitoring to determine at-risk GWSs. 

This rule requires the subset of systems 

with sanitary survey significant 

deficiencies or source water fecal 

contamination to complete corrective 

actions in a timely manner to ensure 

public health protection. Failure to 

complete corrective actions within 120 

days, including meeting deadlines for 

interim actions and measures, or 

comply with a State-approved corrective 

action plan and schedule, constitutes a 

treatment technique violation under this 

rule. 

BILLING CODE 6560–50–P 


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BILLING CODE 6560–50–C 

1. What Are the Requirements of This 

Rule? 

When a system has a significant 

deficiency, it must consult with the 

State regarding appropriate corrective 

action within 30 days of receiving a 

written notice of the significant 

deficiency. When a system receives a 

written notice from a laboratory 

indicating a fecal indicator positive 

result in one of the five additional 

triggered source water monitoring 

samples, the system must consult with 

the State regarding appropriate 

corrective action. When a system 

receives a written notice from a 

laboratory indicating a fecal indicator 


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positive result and the State has 

determined that corrective action is 

necessary, the system must consult with 

the State regarding appropriate 

corrective action. Consultation must 

take place within 30 days. In any event, 

the State may specify corrective action 

without consultation. In the 

consultation process, the State may 

approve and/or modify corrective 

actions and completion schedules 

proposed by the system, or the State 

may specify alternatives. The State may 

also specify interim corrective action 

measures. 

The GWR rule requires that within 

120 days (or earlier if directed by the 

State) of receiving the notification from 

the State or laboratory described in the 

preceding paragraph, the GWS must 

either (i) Complete appropriate 

corrective actions in accordance with 

applicable State plan review processes 

or other State guidance or direction, or 

(ii) be in compliance with a Stateapproved corrective action plan and 

schedule. If a system is unable to 

complete corrective action within 120 

days or on the schedule specified by the 

State, then the system is in violation of 

the treatment technique requirement. 

Systems must notify the State within 

30 days of completing any State 

approved or specified corrective action. 

As a condition of primacy, States must 

verify that the corrective action has been 

completed within the next 30 days. 

States may verify that the corrective 

action has been completed and has 

successfully addressed the significant 

deficiency and/or fecal contamination 

in the ground water source either by a 

site visit or by written documentation 

from the system, which could consist of 

the system’s notification to the State. 

a. What corrective action alternatives 

are provided for in this rule? When a 

system has a significant deficiency or a 

fecal indicator-positive ground water 

source sample (either by the initial 

triggered sample, or positive additional 

sample, as determined by the State), the 

GWS must implement one or more of 

the following corrective action options: 

(1) Correct all significant deficiencies 

(e.g., repairs to well pads and sanitary 

seals, repairs to piping tanks and 

treatment equipment, control of crossconnections); (2) provide an alternate 

source of water (e.g., new well, 

connection to another PWS); (3) 

eliminate the source of contamination 

(e.g., remove point sources, relocate 

pipelines and waste disposal, redirect 

drainage or run-off, provide or fix 

existing fencing or housing of the 

wellhead); or (4) provide treatment that 

reliably achieves at least 4-log treatment 

of viruses (using inactivation, removal, 

or a State-approved combination of 

4-log virus inactivation and removal) 

before or at the first customer for each 

ground water source requiring 

corrective action. 

b. Compliance monitoring for systems 

providing at least 4-log treatment of 

viruses. This rule also establishes 

compliance monitoring requirements for 

GWSs that provide at least 4-log 

treatment of viruses as a corrective 

action. This rule also establishes 

compliance monitoring requirements for 

those systems that have notified the 

State that they provide at least 4-log 

treatment of viruses for their ground 

water sources before the first customer 

and are therefore not required to meet 

the triggered source water monitoring 

requirement of this rule. 

Treatment technologies capable of 

providing at least a 4-log treatment of 

viruses include the following: 

• Inactivation, with a sufficient 

disinfection concentration and contact 

time, through disinfection with 

chlorine, chlorine dioxide, ozone, or 

through anodic oxidation. Disinfectant 

concentration and contact time (CT) can 

be based on existing CT tables (USEPA, 

1991) or State-approved alternatives. 

• Removal with membrane 

technologies with an absolute molecular 

weight cut-off (MWCO), or an alternate 

parameter that describes the exclusion 

characteristics of the membrane, that 

can reliably achieve at least a 4-log 

removal of viruses. 

• Inactivation, removal or 

combination of inactivation and 

removal through alternative treatment 

technologies (e.g., ultraviolet radiation 

(UV)) approved by the State, if the 

alternative treatment technology, alone 

or in combination (e.g., UV with 

filtration, chlorination with filtration), 

can reliably provide at least 4-log 

treatment of viruses. 

Under this rule, systems providing 4- 

log treatment of viruses using chemical 

disinfection must monitor for and must 

meet and maintain a State-determined 

residual disinfectant concentration (e.g., 

4-log inactivation of viruses based on 

CT tables) or State-approved alternatives 

every day the GWS serves from the 

ground water source to the public. 

Systems serving greater than 3,300 

people and using chemical disinfection 

(e.g., chlorine) to provide 4-log 

inactivation must continuously monitor 

the residual disinfectant concentration 

using analytical methods specified in 

§ 141.74(a)(2) (Analytical and 

monitoring requirements) at a location 

approved by the State, and record the 

lowest residual disinfectant level each 

day that the GWS serves water from the 

ground water source to the public. The 

system must maintain the Statedetermined residual disinfectant 

concentration every day the GWS serves 

from the ground water source. 

Systems serving 3,300 people or fewer 

that use chemical disinfection must 

monitor the residual disinfectant 

concentration using analytical methods 

specified in § 141.74(a)(2) (Analytical 

and monitoring requirements) at a 

location approved by the State either by 

taking at least one grab sample every 

day the GWS serves water to the public 

or by continuously monitoring the 

disinfectant residual. Systems collecting 

grab samples must record the 

disinfectant residual level each day that 

the GWS serves water from the ground 

water source to the public. The system 

must take a grab sample during the hour 

of peak flow or at another time specified 

by the State. Systems serving 3,300 

people or fewer that use continuous 

residual monitoring equipment must 

record the lowest residual disinfectant 

level each day that the GWS serves 

water from the ground water source to 

the public. 

If a GWS taking grab samples has a 

sample measurement that falls below 

the State-specified residual disinfectant 

concentration, then the system must 

take follow-up samples at least every 

four hours until the State-specified 

residual disinfectant level is restored. If 

a system using continuous monitoring 

equipment fails to maintain the Statespecified disinfectant residual level 

necessary to achieve 4-log inactivation 

of viruses, the system must restore the 

disinfectant residual level to the Statespecified level within four hours. If 

continuous disinfectant monitoring 

equipment fails, the GWS must take a 

grab sample at least every four hours 

until the equipment is back on-line. The 

system has 14 days to resume 

continuous monitoring. Failure to 

restore the residual disinfectant level to 

that required for 4-log inactivation of 

viruses within four hours, using either 

continuous monitoring or grab 

sampling, is a treatment technique 

violation. 

Ground water systems that use a 

membrane filtration treatment 

technology must maintain the integrity 

of the membrane and monitor and 

operate the membrane filtration system 

in accordance with State-specified 

monitoring and compliance 

requirements (e.g., membrane 

performance parameters and integrity 

testing). If a system fails to meet these 

requirements or maintain the integrity 

of the membrane, it must correct the 

problem within four hours or be in 

violation of the treatment technique 

requirement. 


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Systems that use a State-approved 

alternative treatment technology must 

monitor and operate the alternative 

treatment in accordance with all 

compliance requirements that the State 

determines to be necessary to 

demonstrate that at least 4-log treatment 

of viruses is achieved. If the system does 

not comply with these requirements, 

fails to maintain at least 4-log treatment 

of viruses, and does not restore proper 

operation within four hours, the system 

is in violation of the treatment 

technique requirement. 

GWSs providing at least 4-log 

treatment of viruses may discontinue 

treatment if the State determines (e.g., 

based on source water monitoring or 

replacement of the source) and 

documents in writing that the need for 

4-log treatment of viruses no longer 

exists for that ground water source. 

GWSs that discontinue treatment with 

State approval must comply with the 

triggered source water requirements of 

this rule. GWSs that provide 4-log 

treatment of viruses and notify the State 

that they are not subject to the source 

water monitoring requirements of this 

rule but subsequently discontinue 4-log 

treatment of viruses must have State 

approval and must comply with the 

triggered source water requirements of 

this rule. 

2. What Is EPA’s Rationale for the GWR 

Treatment Technique Requirements? 

EPA believes that fecal contamination 

in ground water sources of 

undisinfected or minimally disinfected 

GWSs and significant deficiencies 

demonstrate public health risks that 

require prompt corrective action. 

Application of corrective actions in 

cases of source water fecal 

contamination or significant 

deficiencies provides benefits of 

eliminating existing problems and can 

also preempt future public health risks, 

such as an outbreak. EPA believes that 

requiring treatment technique 

provisions to respond to fecally 

contaminated ground water sources 

and/or significant deficiencies 

identified by sanitary surveys will 

provide enforcement authority to EPA 

and States to ensure that appropriate 

corrective actions will be implemented. 

The GAO reported that failure to 

correct deficiencies identified in 

sanitary surveys is a significant concern 

(USGAO, 1993). An analysis of Best 

Management Practices (BMPs) (ASDWA, 

1998) showed that correction of 

deficiencies was correlated with lower 

levels of total coliform, fecal coliform, 

and E. coli. Therefore, EPA believes that 

the treatment technique requirements in 

this rule will result in reduced 

exposures to fecal contamination and 

associated health risks. 

Findings from a review of the 

Environmental Law Reporter contained 

in the Baseline Profile Document for the 

Ground Water Rule (USEPA, 2000g) 

indicate that (1) Not all States 

specifically require systems to correct 

deficiencies, and (2) a number of States 

may not have the legal authority to 

require systems to correct deficiencies. 

The treatment technique requirements 

of this rule provide for timely 

correction, as well as public 

notification, of fecal contamination and 

significant deficiencies. Treatment 

corrective actions provide for 

inactivation or removal of microbes of 

public health concern in some ground 

waters and results in reduced exposures 

and associated health risks. The rule 

also allows non-treatment alternatives 

such as removing the source of 

contamination or providing an alternate 

source water, both of which also result 

in reduced exposures and associated 

health risks. 

To avoid unwarranted action, EPA 

has added a provision under the final 

rule that allows additional sampling of 

the source water with the initial fecal 

indicator-positive sample before 

requiring corrective action. If the State 

determines that corrective action is 

appropriate from the initial fecal 

indicator-positive finding, then no 

additional sampling would be required. 

This provision is discussed in Section 

IV.B.2.a. 

a. Corrective Actions and Treatment 

Technique Requirements. To develop 

the treatment technique requirements, 

EPA evaluated existing State 

requirements and the measures 

available to systems to address fecal 

contamination. EPA believes that 

effective corrective actions include 

correcting significant deficiencies, 

eliminating the source of contamination, 

providing an alternate source of safe 

drinking water, or providing 4-log 

treatment of viruses. States and systems 

have the flexibility to take site-specific 

factors into consideration when 

implementing these corrective actions. 

i. Corrective action technologies. 

Chemical disinfection technologies are 

commonly used by both ground water 

and surface water systems to provide 

disinfection prior to distribution of 

drinking water. EPA believes that 4-log 

inactivation is protective in disinfecting 

GWSs (see Figure III–1). Under the 

SWTR, EPA requires at least 4-log 

removal and/or inactivation of viruses. 

Since the frequency of viral occurrence 

and virus concentrations are generally 

lower in ground water supplies than in 

surface water supplies, EPA believes the 

4-log requirement for GWSs is as 

protective as the current treatment 

requirements for surface water supplies. 

Figure III–1 indicates the range of 

protection anticipated from the 4-log 

requirement for GWSs having viral 

contamination in their source water. 

Numerous studies have investigated 

the efficacy of chemical disinfectants to 

inactivate viruses. Free chlorine was 

shown to be able to achieve 4-log 

inactivation of hepatitis A virus (HAV) 

at a temperature of 15 degrees Celsius, 

a pH of 6–9, and a CT of four mg-min/ 

L (USEPA, 1991). Chlorine dioxide 

achieves 4-log inactivation of HAV at a 

temperature of 15 degrees Celsius, a pH 

of 6–9, and a CT of 16.7 mg-min/L 

(USEPA, 1991). Ozone achieves a 4-log 

inactivation of poliovirus at a 

temperature of 15 degrees Celsius, a pH 

of 6–9, and a CT of 0.6 mg-min/L 

(USEPA, 1991). Chemical disinfection is 

a demonstrated technology that can 

achieve 4-log inactivation of viruses. 

The CT value needed to provide 4-log 

inactivation of viruses is dependent on 

site-specific conditions, including the 

disinfectant demand, water temperature 

and pH. States and systems may use 

existing inactivation (CT) tables 

(USEPA, 1991) or State-approved 

alternatives to determine the chemical 

disinfectant doses required to achieve a 

4-log inactivation of viruses. 

Membrane filtration technologies can 

achieve 4-log or greater removal of 

viruses, as long as the absolute MWCO 

of the membrane, or alternate parameter 

that describes the exclusion 

characteristics of the membrane, is 

smaller than the diameter of viruses. For 

instance, reverse osmosis (RO) can 

achieve greater than 4-log removal of 

particles (including viruses) larger than 

0.5 nm in diameter when the absolute 

MWCO of the RO membrane is less than 

0.5 nm (Jacangelo et al., 1995). In 

addition, nanofiltration (NF) can 

achieve greater than 4-log removal of 

particles with a diameter of 0.5 nm or 

larger when the absolute MWCO of the 

NF membrane is 200–400 Daltons. 

Viruses range in diameter from 20–900 

nm. The absolute MWCOs of specific 

membranes must be determined for the 

specific membranes to meet these 

conditions. This rule also allows for 

other filtration treatment technologies to 

be used to meet the 4-log treatment 

requirement. 

The GWR proposal explicitly 

included UV light in the regulatory text 

as a stand-alone treatment technology 

that could provide a 4-log virus 

inactivation. However, data published 

subsequent to the GWR proposal 

indicated that some viruses, particularly 

adenoviruses, are very resistant to UV 


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light. The GWR proposal was based on 

information available at the time of the 

proposal regarding UV doses required to 

provide a 4-log inactivation of HAV and 

the design doses achieved by available 

UV reactors, which are lower than the 

UV doses needed to achieve 4-log 

inactivation of adenovirus. 

Further, EPA believes that UV 

reactors must undergo challenge testing 

to validate the dose level delivered so 

that effective public health protection is 

provided in systems using UV 

disinfection. At present, EPA is unaware 

of available challenge testing procedures 

that can be used to validate the 

performance of UV reactors at dose 

levels needed for a 4-log inactivation of 

adenovirus. 

The final GWR modifies the proposal 

by removing the explicit reference to UV 

as a stand-alone technology to achieve 

4-log virus inactivation. EPA is 

concerned that fecally-contaminated 

ground water may contain adenoviruses, 

or other viruses, that are more resistant 

to UV inactivation than HAV, and 

currently available testing procedures 

cannot validate UV reactor performance 

at the UV dose levels needed for 

inactivation. 

EPA believes that UV technology can 

be used in a series configuration or in 

combination with other inactivation or 

removal technologies to provide a total 

4-log treatment of viruses to meet this 

rule’s requirements. EPA also believes 

that a UV reactor dose verification 

procedure for 4-log inactivation of a 

range of viruses may be developed in 

the future. With the future development 

of UV validation procedures, it may 

become feasible for systems to 

demonstrate that they can achieve 4-log 

inactivation of viruses with a single UV 

light reactor. Therefore, this rule allows 

States to approve and set compliance 

monitoring and performance parameters 

for any alternative treatment, including 

UV light or UV light in combination 

with another treatment technology, that 

will ensure that systems continuously 

meet the 4-log virus treatment 

requirements. This requirement is both 

protective of public health and provides 

systems and States with needed 

flexibility for site-specific decisions. It 

ensures protection against known heath 

risks associated with waterborne 

viruses; allows systems to make use of 

technologies that are already in place or 

are more appropriate for the system’s 

size, location, or configuration; and 

provides the opportunity for systems to 

take advantage of future technology 

developments. 

ii. Corrective action time frame. EPA 

believes that timely correction of source 

water fecal contamination and 

significant deficiencies in GWSs is an 

essential component of the public 

health measures presented in this rule. 

EPA has extended the proposed 90- 

day deadline for completing corrective 

actions to 120 days, which includes 

additional time for a 30-day GWS/State 

consultation period. In the case of 

source water fecal contamination, an 

investigation into the cause of 

contamination should be conducted 

during this 30 day period. This 

consultation allows the State, in 

discussion with the system, to 

determine the most appropriate 

corrective action for the problem 

identified to ensure public health 

protection. To reduce burden, the State 

may specify the corrective action in its 

significant deficiency notice to the 

system. 

EPA believes that in many situations, 

a system can complete corrective 

actions within 120 days because many 

corrective actions are easy to 

implement, such as repairing a well 

seal. Where this is not the case, for 

example if a system needs to make 

capital improvements, the GWR allows 

States to determine an alternate 

schedule. The State is in the best 

position to make these case-by-case 

determinations of the most appropriate 

schedule to protect public health. The 

GWR also allows the State to require 

immediate interim corrective action to 

protect consumers while longer-term 

actions are implemented. 

There may be cases in which systems 

and States have thoroughly investigated 

and cannot determine the cause of fecal 

contamination of the source water and 

believe that the source is no longer 

vulnerable to such contamination. If the 

State determines based on follow-up 

monitoring or other evidence that the 

contamination is unlikely to occur 

again, the State may consider the source 

of contamination to be eliminated. EPA 

considers such a system to be high risk 

and recommends that States follow up 

such a determination with assessment 

source water monitoring as described in 

Section IV.B.2.b. Commenters supported 

State discretion in making systemspecific decisions. EPA is providing this 

interpretation in support of this goal. 

iii. Discontinuing treatment. If the 

State determines that the need for 4-log 

treatment no longer exists, the State may 

allow a system to discontinue treatment. 

EPA believes that in certain situations 

(i.e., consolidation, replacement or 

rehabilitation of ground water sources, 

mitigation of source of contamination), 

where both corrective action has 

addressed the public health risks and 

the system has demonstrated to the 

State that corrective action has been 

successful (e.g., through source water 

monitoring or sanitary surveys), it may 

be appropriate to allow systems to 

discontinue 4-log treatment of ground 

water sources. If the State allows a 

system to discontinue 4-log treatment, 

the system is then subject to the source 

water monitoring requirements of this 

rule. 

b. Monitoring for the Effectiveness 

and Reliability of Treatment. All GWSs 

that provide treatment must routinely 

monitor the treatment effectiveness to 

ensure that public health is protected. 

Because of considerations regarding 

resources and the technical capacities of 

small water systems, this rule includes 

different monitoring requirements for 

systems of different sizes while still 

effectively ensuring public health 

protection. The 1996 Amendments to 

the SDWA recognized the importance of 

considering both the special needs of 

small systems that serve 3,300 people or 

fewer and the need to ensure equal 

public health protection to consumers 

served by small and large PWSs. 

EPA believes that it is appropriate for 

disinfecting systems serving greater than 

3,300 people to install and operate 

continuous disinfection monitoring 

equipment. These systems will 

generally have the expertise to operate 

and maintain the necessary equipment, 

and continuous monitoring and 

recording will alleviate some of the 

monitoring burden for larger systems. 

Systems serving 3,300 people or fewer 

are provided the flexibility to use either 

grab sampling or continuous 

monitoring. This option is important 

because some small systems may not 

have the capacity to purchase, operate, 

and maintain continuous disinfection 

monitoring equipment. For all systems, 

the monitoring must take place at or 

prior to the first customer to ensure that 

the required level of treatment has been 

achieved prior to serving water to the 

public. 

For GWSs that use membrane 

filtration systems to achieve at least 

4-log removal of viruses, the system 

must monitor the membrane filtration 

process in accordance with all Statespecified monitoring requirements. In 

addition, the system must operate the 

membrane filtration in accordance with 

all State-specified compliance 

requirements. A GWS that uses 

membrane filtration is in compliance 

with the 4-log removal requirement for 

viruses when: 

• The membrane has an absolute 

MWCO, or alternate parameter that 

describes the exclusion characteristics 

of the membrane, that can reliably 

achieve 4-log removal of viruses; 


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• The membrane process is operated 

in accordance with State-specified 

compliance requirements; and 

• The integrity of the membrane is 

intact. 

To ensure compliance with the virus 

removal requirements of the GWR in 

systems that practice membrane 

filtration, systems must monitor to 

verify that the membrane filtration is 

operating as specified and that the 

membrane is intact. Without these 

compliance monitoring requirements, 

failure of membrane filtration may not 

be detected by the system and 

consumers may be exposed to 

potentially fecally contaminated water. 

This could result in a failure to maintain 

at least 4-log treatment of viruses. 

In cases where 4-log treatment of 

viruses is interrupted, the requirement 

that systems must restore 4-log 

treatment of viruses is consistent with 

requirements for surface water systems 

under the SWTR (USEPA, 1989b) and 

protects public health while providing 

flexibility for GWSs to address 

operational issues. 

If the State has not approved 

compliance criteria for the system to use 

to demonstrate 4-log treatment by the 

time that the system is required to 

conduct compliance monitoring, the 

system should comply with ground 

water source monitoring in § 141.402 

until the State approves compliance 

criteria for the system to use to 

demonstrate 4-log treatment. EPA is 

concerned that systems may 

inadvertently provide inadequately 

treated water (i.e., < 4-log treatment) if 

they are not using State approved 

compliance criteria. 

3. What Were the Key Issues Raised by 

Commenters on the Proposed GWR 

Treatment Technique Requirements? 

a. State Consultation Versus 

Approval. EPA received many 

comments related to the State’s ability 

to require the system to implement a 

specific treatment technique in response 

to significant deficiencies or source 

water fecal contamination. The 

proposed GWR required the system only 

to consult with the State on the 

appropriate corrective action option for 

the system. Several commenters 

expressed concern that with only a 

consultation requirement, a system 

could implement a treatment technique 

that the State would consider 

inappropriate or unreliable, such as 

disinfection by a system that is 

incapable of reliably operating a 

disinfection treatment system. To 

address these concerns, the final GWR 

requires systems to implement 

corrective actions in accordance with 

applicable State plan review processes, 

or other State guidance or direction, 

including interim measures, or be in 

compliance with a State-approved 

corrective action plan and schedule. 

EPA believes that existing State plan 

review and permitting activities, such as 

those established in accordance with the 

primacy requirements at § 142.10(b)(5), 

will ensure that systems implement the 

most appropriate corrective action. 

b. UV Disinfection. EPA received 

comments on the use of UV technology 

to meet the treatment technique 

requirements of the GWR. The GWR 

proposal included UV as a stand-alone 

treatment to meet the GWR treatment 

requirements and provided monitoring 

requirements for systems using UV 

technology, as well as State-determined 

performance requirements for UV 

technology. 

Commenters requested more 

information on the use of UV for virus 

inactivation, including UV dose tables 

and criteria to assist States in evaluating 

UV reactors. Commenters also noted 

that data published subsequent to the 

GWR proposal indicated that some 

viruses, in particular adenoviruses, are 

very resistant to UV light. Data show 

that a dose of 186 mJ/cm2 is required to 

achieve 4-log inactivation of adenovirus 

(68 FR 47713, August 11, 2003) (USEPA, 

2003c). This information suggests that 

HAV, the virus considered in the GWR 

proposal discussion of UV, may not be 

an appropriate indicator of the virus 

inactivation performance of UV reactors. 

EPA agrees that UV reactors may need 

to provide higher doses than those 

contemplated in the GWR proposal to 

achieve 4-log inactivation of viruses. 

Moreover, there is currently limited 

information available for States to make 

determinations regarding performance 

requirements for UV reactors to ensure 

that adequate virus inactivation is being 

achieved. 

Further, EPA believes that testing of 

full-scale UV reactors is necessary to 

ensure disinfection performance and a 

consistent level of public health 

protection. Full-scale testing avoids the 

significant difficulties encountered in 

predicting UV reactor disinfection 

performance based solely on modeled 

results or the results of testing at a 

reduced scale. All flow-through UV 

reactors deliver a distribution of doses 

due to variations in light intensity 

within the UV reactor and the different 

flow paths of particles passing through 

the reactor. The reactor-delivered dose 

also varies temporally due to processes 

such as UV lamp aging and fouling, 

changes in UV absorbance of the water 

being treated, and fluctuations in reactor 

flow rates. 

A full-scale test typically involves 

using a surrogate microorganism. 

However, EPA is not aware of an 

available challenge microorganism that 

allows for full-scale testing of UV 

reactors to demonstrate a 4-log 

inactivation of adenovirus. EPA believes 

that methodologies for challenge testing 

at doses necessary to inactivate UVresistant viruses may be developed in 

the future. 

The final GWR does not include 

specific performance, monitoring, or 

design requirements related to the use of 

UV technology. This is based on the 

comments received regarding the use of 

UV technology to meet the GWR 

requirements, new data regarding UV 

dosages necessary for virus inactivation, 

and the difficulties in performing fullscale demonstrations of 4-log virus 

inactivation at those doses. 

However, EPA does believe that UV 

technology may be used in a series 

configuration or in combination with 

other inactivation or removal 

technologies to provide a total 4-log 

treatment of viruses to meet this rule’s 

requirements. The State has the 

flexibility to approve treatment 

alternatives not specified in the rule, 

which could include UV disinfection. 

When using an alternative treatment 

technology, the State must specify 

monitoring and compliance 

requirements necessary to ensure that 

the virus treatment requirements of this 

rule are being met. The alternative 

treatment option in this rule could be 

applied to stand-alone UV disinfection 

if challenge testing protocols for 4-log 

virus inactivation are developed in the 

future. 

c. Corrective Action Time Frame. EPA 

requested comment on the 

appropriateness of the time frame for 

providing corrective actions. Several 

commenters suggested that the proposed 

90-day corrective action time frame was 

too short and that systems would not be 

able to meet this deadline. Some 

commenters also stated that 90 days 

would not be sufficient for systems 

seeking an extension of the 90-day 

deadline for completing the corrective 

action to obtain State approval of a plan 

and schedule within 90 days due to 

factors outside of the system’s control, 

such as the need to obtain competitive 

bids or to gain the approval of the local 

government. On the other hand, several 

commenters stated that a 90-day 

corrective action time frame for systems 

with fecally contaminated source water 

was too long and would place 

consumers at an increased risk. 

EPA received additional comments 

opposing the requirement on the State 

to approve corrective action plans 


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within the same 90 days required for the 

system to submit the plans (for systems 

seeking an extension of the 90-day 

deadline for completing the corrective 

action). The commenters pointed out 

that under the proposed rule, systems 

could potentially submit plans on the 

90th day, leaving insufficient time for 

the State to review the plans. 

The final GWR extends the proposed 

90-day deadline for completing 

corrective actions from 90 to 120 days, 

which includes additional time for an 

initial 30-day GWS/State consultation 

period. This 30-day consultation serves 

a number of purposes. First, GWSs and 

States can investigate the cause of 

contamination. Second, the GWS and 

State may consult on the most 

appropriate corrective action. Third, the 

GWS and State may develop a corrective 

action plan and schedule that could 

extend beyond the 120-day period if 

necessary. This addresses the concerns 

that GWSs would not be able to 

complete their corrective action or 

receive an extension. This consultation 

period provides the GWS and State the 

assurance requested by commenters that 

they not be subject to factors outside of 

their control. Concerns about corrective 

action taking too long have been 

addressed by the provision to require 

GWSs to do interim corrective action 

measures at the State’s request. In 

addition, this rule requires States to 

identify in their primacy application 

their rules or other authorities to 

demonstrate that they can ensure that 

GWSs take the appropriate corrective 

action, including interim measures, if 

necessary, pending completion of 

corrective actions. 

EPA believes that the revised process 

for corrective actions under this rule 

will (1) Allow the State to ensure that 

the system is held accountable in a 

reasonable time frame for implementing 

corrective actions, and (2) utilize the 

strengths of existing State plan review 

processes or other State guidance, 

requirements, or direction. Systems and 

States continue to have the flexibility to 

complete corrective action on a more 

rapid schedule than 120 days. 

D. Providing Notification and 

Information to the Public 

Section 1414(c)(1) of the 1996 SDWA 

amendments requires that PWSs notify 

persons served when violations of 

drinking water standards occur. EPA 

published a revised Public Notification 

Rule (PNR) in 2000 (65 FR 25981, May 

4, 2000) (USEPA, 2000j). Subsequent 

EPA drinking water regulations that 

affect public notification requirements 

typically include amendments to the 

PNR as a part of the individual 

rulemaking. This rule amends the PNR 

at § 141.202(a) and § 141.203(a) and 

requires Tier 1 notice for detection of a 

fecal indicator in a ground water source 

sample (see § 141.403) and Tier 2 notice 

for treatment technique violations (see 

§ 141.404). Also, this rule requires Tier 

3 notice for monitoring violations (see 

§ 141.403 or § 141.404(b)). In addition, 

this rule amends the Consumer 

Confidence Report (CCR) (§ 141.153(b) 

Appendix A to subpart O) requirements 

and includes language to be used when 

informing the public of significant 

deficiencies and fecal indicator-positive 

results in ground water source samples. 

Since the CCR only applies to CWSs, a 

special notice requirement for 

uncorrected significant deficiencies is 

included in the treatment technique 

section of this rule for NCWSs. The 

language included in this section 

parallels language included in the CCR. 

Table IV–4 summarizes the GWR 

notification requirements. 

The purpose of public notification is 

to alert customers of potential risks from 

violations of drinking water standards 

and to inform them of any steps they 

should take to avoid or minimize such 

risks. A PWS is required to give public 

notice when it fails to comply with 

existing drinking water regulations, has 

been granted a variance or exemption 

from the regulations, or is facing other 

situations posing a potential risk to 

public health. Public water systems are 

required to provide such notices to all 

persons served by the water system. The 

PNR divides the public notice 

requirements into three tiers, based on 

the seriousness of the violation or 

situation. 

Tier 1 is for violations and situations 

with significant potential to have 

serious adverse effects on human health 

as a result of short-term exposure. 

Notice is required within 24 hours of 

the violation. Drinking water regulation 

Tier 1 notice violation categories and 

other situations include, but are not 

limited to, the following: 

• An acute violation of the MCL for 

total coliforms when fecal coliform or E. 

coli are present in the water distribution 

system, or when the water system fails 

to analyze the sample for fecal coliforms 

or E. coli when any repeat sample tests 

positive for coliform (as specified in 

§ 141.21(e)); 

• Occurrence of waterborne disease 

outbreaks, or other waterborne 

emergencies; and 

• Other violations or situations with 

significant potential to have serious 

adverse effects on human health as a 

result of short-term exposure, as 

determined by the State either in its 

regulations or on a case-by-case basis. 

The State is explicitly authorized to add 

other violations and situations to the 

Tier 1 list when necessary to protect 

public health where short-termexposure 

is a concern. 

Tier 2 is for other violations and 

situations with the potential to have 

serious adverse effects on human health. 

Notice is required within 30 days, with 

an extension of up to three months 

permitted at the discretion of the State. 

Violations requiring a Tier 2 notice 

include all MCL and treatment 

technique violations, except where Tier 

1 notice is required, and specific 

monitoring violations when determined 

by the State. 

Tier 3 is for all other violations and 

situations requiring a public notice not 

included in Tier 1 and Tier 2. Notice is 

required within 12 months of the 

violation and may be included in the 

Consumer Confidence Report at the 

option of the water system. Violations 

requiring a Tier 3 notice are principally 

monitoring and reporting violations. 

1. What Are the Requirements of This 

Rule? 

a. GWR violations requiring a Tier 1 

notice. A Tier 1 notice is required if a 

GWS has a ground water source sample 

collected under § 141.402(a) or 

§ 141.402(b) that is positive for one of 

the three fecal indicators that are 

discussed in Section IV.B and is not 

invalidated by the State. 

b. GWR violations requiring a Tier 2 

notice. A Tier 2 notice is required if: 

• A GWS with a significant 

deficiency or with fecal contamination 

in the ground water source fails to take 

corrective action in accordance with the 

treatment technique requirements in 

§ 141.403(a); 

• A GWS fails to comply with a Stateapproved schedule and plan, including 

State-specified interim measures, to 

correct a significant deficiency and/or 

eliminate fecal contamination in a 

ground water source at any time after 

State approval or State direction 

pursuant to § 141.403(a)(2); or 

• A GWS provides 4-log treatment of 

viruses but fails to maintain 4-log 

treatment, and the GWS does not restore 

4-log treatment within four hours. 

c. GWR violations requiring a Tier 3 

notice. A Tier 3 public notice is required 

for failure to conduct required ground 

water source monitoring, including 

source water monitoring when a system 

has a total coliform-positive sample in 

the distribution system (§ 141.402(a)(2)), 

source water monitoring following a 

fecal indicator source water positive 

(§ 141.402(a)(3)), and, if required by the 

State, assessment source water 

monitoring (§ 141.402(b)). Additionally, 


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failure to conduct required compliance 

monitoring (§ 141.403(b)) requires a Tier 

3 public notice. 

d. Special notice informing the public 

of significant deficiencies and fecal 

indicator-positives in ground water 

source samples. In addition to the 

public notice requirements of § 141.202, 

§ 141.203, and § 141.204, this rule 

requires PWSs that use ground water 

sources to inform customers of an 

uncorrected significant deficiency and 

CWSs to inform customers of a fecal 

indicator-positive ground water source 

sample that is not invalidated by the 

State. Under this rule, the GWS must 

continue to inform the public annually 

until the significant deficiency is 

corrected and, in the case of CWSs, the 

fecal contamination in the ground water 

source is addressed under § 141.403(a). 

The State may also direct GWSs to 

inform the public of corrected 

significant deficiencies. 

The information provided to the 

public must include the following (as 

applicable to CWSs and NCWSs as 

described above): (1) The nature of the 

uncorrected significant deficiency or 

fecal contamination (for CWSs), if the 

source is known, and the date the 

significant deficiency was identified by 

the State or the date of the fecal 

indicator-positive ground water source 

sample (for CWSs); (2) for CWSs, if the 

fecal contamination in the ground water 

source has been addressed under 

§ 141.403(a) and the date of elimination; 

(3) the State-approved plan and 

schedule for correction including 

interim measures, progress to date, and 

any interim measures completed, for 

any significant deficiency and for CWSs, 

fecal contamination in the ground water 

source that has not been addressed 

under § 141.403(a); (4) for CWSs, a 

description of the potential health 

effects using the health effects language 

of § 141.153, Appendix A to subpart O, 

if the system receives notice of a fecal 

indicator-positive ground water source 

sample that is not invalidated by the 

State; and (5) if directed by the State, 

notification of corrected deficiencies 

and how and when they were corrected. 

To satisfy these special notification 

requirements, the GWR requires a CWS 

to inform the public served by the water 

system in the CCR. A NCWS must 

inform the public served by the water 

system in a manner approved by the 

State (e.g., posting in conspicuous 

places in the area served by the water 

system for a period of time or 

distributing information directly to the 

public served by the water system) 

within 12 months of being notified of a 

significant deficiency. Systems must 

continue to inform the public annually 

until the significant deficiency is 

corrected and, in the case of CWSs, fecal 

contamination in the ground water 

source is addressed in accordance with 

§ 141.403(a). If a significant deficiency 

is corrected before the next CCR is 

issued (for CWSs) or within 12 months 

(for non-CWSs), public notification is 

not required unless directed by the 

State. 

TABLE IV–4.—SUMMARY OF GWR PUBLIC NOTIFICATION REQUIREMENTS

Systems must comply with the following 

notification requirements when . . . Reference 

Tier 1 Public Notification 

Triggered source water monitoring sample or assessment source water 

monitoring sample is positive for E. coli, enterococci, or coliphage 

(and is not invalidated).

§ 141.402(g). 

Tier 2 Public Notification 

A system fails to take corrective action following: § 141.404(d). 

› State direction to take corrective action for a fecal indicatorpositive sample, 

› Receipt of laboratory notice of fecal indicator-positive ground 

water source sample as a result of triggered source water monitoring under § 141.402(a)(3), or 

› Receipt of State written notice of significant deficiency. 

A system fails to comply with a State-approved schedule and plan (including interim measures) related to correcting a significant deficiency and/or eliminating fecal contamination in a ground water 

source.

§ 141.404(d). 

A system that elects to provide such treatment in lieu of triggered 

source water monitoring fails to maintain 4-log treatment of viruses 

[NOTE: There is no violation and public notification required if the 

system restores 4-log treatment within four hours.].

§ 141.404(d). 

Tier 3 Public Notification 

A system fails to conduct triggered source water monitoring or assessment source water monitoring.§ 141.403(d). 

A system fails to conduct monitoring to demonstrate compliance with 4- 

log treatment requirement.

§ 141.403(d). 


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TABLE IV–4.—SUMMARY OF GWR PUBLIC NOTIFICATION REQUIREMENTS—Continued 

Systems must comply with the following 

notification requirements when . . . Reference 

Special Notification Requirements 

CWSs: 

System has an uncorrected significant deficiency (or corrected significant deficiency if directed by the State) or a source water 

fecal indicator-positive sample. System must repeat notice annually until significant deficiency corrected or fecal contamination 

addressed in accordance with § 141.403(1). 

› Provide notice as part of CCR. 

› If significant deficiency is corrected before the next CCR, notification is not required unless directed by the State. 

Notice must include: 

—nature of significant deficiency or ground water fecal contamination, and date. 

—if the fecal contamination has been addressed under 

§ 141.403(a), and date. 

—State-approved plan and schedule, including interim measures 

completed (if process ongoing). 

—required fecal indicator-positive language at: 

—§ 141.403(a)(7)(i). 

NCWSs: 

System has an uncorrected significant deficiency (or corrected significant deficiency if directed by the State). System must repeat 

notice annually until significant deficiency corrected. 

› Provide notice in manner approved by the State for significant deficiencies (e.g., posting in conspicuous places in 

service area or direct distribution of information to public 

served). 

› If significant deficiency is corrected within 12 months, notification is not required unless directed by the State. 

Notice must include: 

—nature of significant deficiency and date. 

—State-approved plan and schedule, including interim measures 

completed (if process ongoing). 

—§ 141.403(a)(7)(ii). 

2. What Is EPA’s Rationale for the 

Public Notice Requirements? 

EPA believes that to provide adequate 

public health protection from fecally 

contaminated ground water, the public 

must be informed of both existing and 

potential significant problems. EPA 

recognizes that immediate public 

notification is key to providing effective 

communication when there is an 

imminent public health risk. In the 

proposed rule, EPA considered 

requiring Tier 1 notice for all violations. 

The final GWR, however, requires Tier 

1 notice only when a ground water 

source sample tests positive for one of 

the three fecal indicators that are 

discussed in Section IV.B. The presence 

of a fecal indicator in a ground water 

source sample means that fecal 

contamination is likely to reach 

consumers and may have significant 

potential for serious adverse health 

effects from a short-term exposure. 

Other violations of this rule require Tier 

2 or Tier 3 notice, depending on the 

nature of the violation and potential for 

adverse health effects. 

The Agency believes that it is 

important for the public to be informed 

when systems are unable to comply 

with the GWR requirements that are 

established to protect public health. 

EPA’s intent is for the public to be 

informed within an appropriate time 

frame without unnecessary alarm. 

Under the final GWR, the following 

treatment technique violations have 

been changed from Tier 1 to Tier 2 

notice: 

• Failure to correct a significant 

deficiency and/or eliminate fecal 

contamination in a ground water source; 

• Failure to be in compliance with a 

corrective action schedule and plan 

within 120 days or to comply with the 

plan and schedule after State approval; 

and 

• Failure to restore 4-log treatment of 

viruses within four hours. 

EPA believes that these violations 

require Tier 2 notice because of the 

potential for serious adverse health 

effects from fecal contamination if 

treatment technique requirements are 

not met. Failure to conduct ground 

water source monitoring or compliance 

monitoring under this rule requires a 

Tier 3 notice public notice. EPA 

believes that the public notification 

requirements of this rule are protective 

of public health by providing timely and 

appropriate public notification of 

violations and situations that may affect 

public health. 

Public right-to-know was a key tenet 

of the 1996 Amendments to the SDWA. 

The final GWR requirements allow the 

public to become involved in any 

decision-making process for corrective 

actions taken by the GWS and provide 

information for individual health 

decisions. 

Consistent with the requirements for 

the Consumer Confidence Report (CCR) 

to include all detected regulated 

contaminants, the special public 

information requirements of the GWR 

require CWSs to include information on 

any fecal contamination of its ground 

water sources. In addition to addressing 

the requirements for CCRs, EPA believes 

this notice is important in informing 

individual health decisions. Use of the 

existing CCR public information process 

for CWSs minimizes the burden on 

CWSs. EPA believes that the Tier 1 

notice requirements for NCWSs are 

adequate and appropriate for informing 

the public of fecal contamination of 

ground water sources and providing 

information for individual health 

decisions so no additional notice is 

required for fecal contamination at 

NCWSs. 

EPA also believes that the public must 

be fully informed of uncorrected 

significant deficiencies because such 

deficiencies may affect their water 

supply and pose a health risk. In 

addition, EPA believes that this 

notification of uncorrected significant 

deficiencies will provide an additional 

incentive to water systems for rapid 

correction of significant deficiencies. To 

minimize the burden on CWS the final 

GWR requires them to use the CCR to 

report uncorrected significant 

deficiencies. Because the public served 

by NCWSs do not receive CCRs, this 

rule requires States to determine the 

appropriate method(s) (e.g., posting in 

conspicuous places, hand delivery) for 

NCWSs to inform the public of 

uncorrected significant deficiencies. In 

order to provide the public with 

complete information on their water 

system, GWSs are required to continue 

informing the public of uncorrected 

significant deficiencies until corrective 

actions are completed. 

Under the Tier 1 public notice 

requirements, NCWSs must provide 

public notice of a fecal indicatorpositive source water in a form and 


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manner designed to reach transient and 

non-transient users of the PWS. This 

could include conspicuous posting, 

hand delivery or other methods 

approved by the State. This notice 

would continue until fecal 

contamination is corrected. 

EPA believes that there may be 

circumstances when the public should 

be informed of significant deficiencies 

that have been corrected and that States 

are in the best position to make a 

decision to require notification of the 

public. These circumstances include 

significant deficiencies that, although 

corrected, presented a public health risk 

prior to correction; significant 

deficiencies that were uncorrected for 

long periods of time; and significant 

deficiencies at systems with persistent 

significant deficiency issues. 

Notification in these circumstances 

allows the public served by a PWS to 

become involved in any decisionmaking processes for management, 

operation, and maintenance of the water 

system and it also provides information 

for individual health decisions. 

Notification of corrected significant 

deficiencies that had been uncorrected 

for long periods provides closure for the 

public that has been notified previously 

of the uncorrected significant 

deficiency. In addition, notification of 

corrected significant deficiencies allows 

a community to better evaluate the 

management of their system because 

they will have complete information on 

significant deficiencies at their system. 

3. What Were the Key Issues Raised by 

Commenters on the Proposed GWR 

Public Notification Requirements? 

a. Treatment technique violations. In 

the proposed GWR, EPA considered 

Tier 1 notice for the following: (1) 

Detection of a fecal indicator-positive in 

a ground water source sample that is not 

invalidated by the State; (2) failure to 

correct a State-identified significant 

deficiency or source water fecal 

contamination within 90 days or failure 

to obtain, within the same 90 days, State 

approval of a plan and schedule for 

meeting the treatment technique 

requirement; and (3) failure to perform 

source water monitoring. In general, 

commenters responded that Tier 1 

notice for failure to correct a significant 

deficiency within 90 days or in 

accordance with the State-approved 

time frame is not warranted. Other 

commenters stated that only a 

confirmed fecal indicator-positive 

sample in the source water of a system 

that does not provide 4-log treatment of 

viruses should require Tier 1 notice. A 

few commenters supported EPA’s 

proposed treatment technique violation 

Tier 1 notice. However, most 

commenters suggested that Tier 2 

notice, rather than Tier 1 notice, is 

appropriate for treatment technique 

violations. 

EPA agrees that the public health risk 

associated with documented fecal 

contamination warrants a Tier 1 notice. 

EPA agrees that not all failures to 

correct a significant deficiency warrant 

a Tier 1 notice, since not all significant 

deficiencies will result in an imminent 

danger to public health. For the specific 

case of a failure to correct source water 

fecal contamination, the existing Tier 1 

notification requirements allow States to 

continue to require public notification 

for as long as fecal contamination is 

present. The final GWR also requires 

that CWSs and NCWSs include notice of 

uncorrected significant deficiencies and 

that CWSs provide notice of source 

water fecal contamination for as long as 

significant deficiencies or fecal 

contamination remain uncorrected. 

CWSs must include this in the CCR, and 

NCWSs will use a form of notification 

approved by the State. 

b. Monitoring violations. Some 

commenters responded that failure to 

perform any source water monitoring 

should not require Tier 1 notice but 

rather Tier 2 notice. Other commenters 

stated that failure to conduct triggered 

source water monitoring should require 

a Tier 1 notice, while failure to conduct 

assessment source water monitoring 

should require a Tier 2 notice. In 

general, commenters believed that 

requiring a Tier 1 notice for failure to 

collect a source water sample would 

unnecessarily alarm the public. Other 

commenters supported a Tier 3 notice 

for failure to conduct source water 

monitoring so that the GWR would be 

consistent with other monitoring 

violation notification requirements of 

§ 141.204. 

EPA agrees that failure to collect 

source water samples or conduct 

compliance monitoring may not warrant 

a Tier 1 notification since lack of 

monitoring data does not indicate there 

is an imminent danger to public health 

and such notification could 

unnecessarily alarm the public. 

Consistent with § 141.204, the final 

GWR requires a Tier 3 notice for 

violations of the monitoring 

requirements, failure to collect ground 

water source samples, or failure to 

conduct compliance monitoring. EPA 

notes that States continue to have the 

authority to require a Tier 2 notice for 

monitoring violations if the State 

determines that this level of notification 

is warranted. 

Some commenters stated that since 

the TCR governs the quality of water 

provided to a system’s customers, it is 

inappropriate to require public notice 

for failure to conduct source water 

sampling under the GWR. EPA disagrees 

with the comment and believes that it 

is appropriate to establish public 

notification requirements for GWSs that 

fail to monitor for fecal contamination 

in their source water because fecal 

contamination can be a significant 

health risk. EPA recognizes that the TCR 

protects against distribution system 

contamination; however, as part of the 

GWR risk-targeting strategy, the Agency 

believes that source water monitoring is 

an integral component in both assessing 

potential fecal contamination in the 

source water and eliminating this 

contamination before it reaches the 

distribution systems. 

c. Special notice informing the public 

of significant deficiencies or a fecal 

indicator-positive ground water sample. 

EPA requested comment on practicable 

approaches to involve the public in 

working with their systems to address 

the results of sanitary surveys or 

detection of source water fecal 

contamination. Some commenters 

suggested publishing the results in a 

system’s CCR, reviewing the results at a 

public meeting, or posting the results of 

surveys in a public place for NCWSs. 

Others supported notifying the public 

that the results were available and how 

those results could be obtained. Some 

commenters noted that significant 

deficiencies or source water fecal 

contamination would be corrected 

rapidly and that involving or informing 

the public after the correction might not 

be useful. 

EPA believes that adequate 

opportunities exist for customers to 

obtain general information on the 

sanitary survey of their water supplier 

since the complete sanitary survey 

report is available from both the State 

and the PWS upon request. EPA 

believes that the public served by a 

GWS should be made aware of 

uncorrected significant deficiencies and 

source water fecal contamination. The 

final GWR uses an existing public 

information process, the CCR, to inform 

consumers of water from CWSs of 

uncorrected significant deficiencies 

found during sanitary surveys or of 

source water fecal contamination. 

NCWSs will use a State approved 

process such as continuous posting in 

conspicuous places and hand-delivered 

notices to inform consumers of 

uncorrected significant deficiencies. 

NCWSs will use the State-approved Tier 

1 notification process to notify the 

public of fecal source water 

contamination. No additional notice of 

fecal contamination is required for 


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NCWSs. If directed by the State, GWSs 

must also provide notification of 

corrected significant deficiencies. 

E. What Are the Reporting and 

Recordkeeping Requirements for 

Systems? 

The GWR establishes new reporting 

and recordkeeping requirements for 

GWSs that are necessary to ensure that 

systems continue to meet the 

requirements of the rule and that States 

have the information needed to perform 

their oversight responsibilities. 

Specifically, the GWR reporting 

requirements ensure that States are 

aware of any failure to provide an 

adequate level of treatment, completed 

corrective actions, and system decisions 

that triggered source water monitoring is 

not necessary based on State criteria. 

The recordkeeping requirements of 

this rule ensure that information is 

available to States during sanitary 

surveys or other instances to verify that 

systems are complying with the 

requirements of this rule for corrective 

actions, notice to the public, decisions 

not to conduct triggered source water 

monitoring, and invalidation of fecal 

indicator-positive ground water source 

samples. 

This section discusses the new 

requirements and the key issues raised 

by commenters. 

1. Reporting Requirements 

In addition to the reporting 

requirements of § 141.31, a GWS must 

provide the following information to the 

State (see § 141.405(a)): (1) A GWS 

conducting compliance monitoring 

must notify the State as soon as 

possible, but in no case later than the 

end of the next business day, any time 

the system fails to meet any Statespecified compliance requirements 

including, but not limited to, minimum 

residual disinfectant concentration, 

membrane operating criteria or 

membrane integrity, and alternative 

treatment operating criteria, if operation 

in accordance with the criteria or 

requirements is not restored within four 

hours; (2) a GWS must notify the State 

within 30 days after completing any 

corrective action for GWSs with 

significant deficiencies or source water 

fecal contamination; and (3) if a GWS is 

subject to source water monitoring 

requirements but is not required to 

monitor its source because it determines 

using State criteria that a total coliformpositive samples is related to 

distribution systems conditions 

pursuant to § 141.402(a)(5)(ii), then the 

GWS must provide documentation that 

it met the State criteria to the State 

within 30 days of the total coliformpositive sample. 

2. Recordkeeping Requirements 

In addition to the reporting 

requirements of § 141.31, a GWS must 

maintain the following information in 

its records (see § 141.405(b)): (1) 

Documentation of corrective actions; (2) 

documentation of notice to the public of 

(a) An uncorrected significant 

deficiency, or (b) a fecal indicatorpositive ground water source sample 

that is not invalidated; (3) records of 

decisions where either (a) The State 

determines, and documents in writing, 

that the cause of a total coliformpositive sample collected under routine 

coliform sampling is directly related to 

the distribution system, or (b) the GWS 

determines, according to State criteria, 

that the cause of a total coliformpositive sample collected under routine 

coliform sampling directly relates to the 

distribution system; (4) for consecutive 

systems, documentation of notification 

to the wholesale system(s) of total 

coliform-positive samples that are not 

invalidated; and (5) for systems required 

to perform compliance monitoring (a) 

Records of the lowest daily residual 

disinfectant value and records of the 

date and duration of any failure to 

maintain the State-prescribed minimum 

residual for a period of more than four 

hours, and (b) records of State-specified 

compliance requirements for membrane 

filtration and of parameters specified by 

the State for State-approved alternative 

treatment and records of the date and 

duration of any failure to meet the 

membrane operating, membrane 

integrity, or alternative treatment 

operating requirements for more than 

four hours. 

3. What Were the Key Issues Raised by 

Commenters on the Proposed GWR 

Reporting and Recordkeeping 

Requirements for Systems? 

Most commenters agreed with the 

system recordkeeping and reporting 

requirements in the proposed rule and 

that recordkeeping and submittals are 

appropriate for systems that disinfect. 

Commenters mentioned that these 

requirements should be consistent with 

those required under other regulations, 

such as the TCR or the Stage 1 DBPR. 

EPA agrees that the recordkeeping 

and reporting for systems under this 

rule are appropriate and ensure that 

information is available to the State in 

performing their oversight 

responsibilities. The records must be 

available for review during sanitary 

surveys and investigations of treatment 

technique failures. EPA believes that the 

recordkeeping and reporting 

requirements for systems under this rule 

are consistent with those required under 

other regulations. 

Commenters also mentioned that 

systems should keep documentation of 

how the system operators determined 

the proper disinfectant concentration. 

EPA notes that this is a recordkeeping 

requirement for the State and is required 

under this rule. 

Others commenters stated that 

recordkeeping requirements in the 

proposed rule were unrealistic and 

excessive for extremely small systems 

(such as many NCWSs). EPA notes that 

many of the recordkeeping requirements 

for systems under this rule are 

associated with corrective actions and 

compliance monitoring, and that only 

systems with significant deficiencies, 

source water contamination, or source 

water treatment would be required to 

keep these records. The records must be 

available for review during sanitary 

surveys and investigations of treatment 

technique failures. 

F. What Are the Special Primacy, 

Reporting, and Recordkeeping 

Requirements for States? 

The GWR establishes new special 

primacy, reporting, and recordkeeping 

requirements for States. 

With regards to special primacy 

requirements, 40 CFR part 142, National 

Primary Drinking Water Regulations 

Implementation, sets out the specific 

program implementation requirements 

for States to obtain primacy for the 

Public Water Supply Supervision 

program as authorized under SDWA 

section 1413. In addition to adopting 

basic primacy requirements, States may 

be required to adopt special primacy 

provisions pertaining to specific 

regulations where implementation of 

the rule involves activities beyond 

general primacy provisions. States must 

include these regulation-specific 

provisions in an application for 

approval of their program revision. 

The special primacy conditions of this 

rule (§ 142.16(o)) ensure (1) That States 

have the legal authority to require 

correction of significant deficiencies 

and/or source water fecal 

contamination, as well as the authority 

to require source water monitoring, (2) 

that States adopt and implement 

adequate procedures for sanitary 

surveys, and that (3) States develop 

criteria for source water monitoring and 

treatment technique requirements. 

With regards to reporting and 

recordkeeping, the SDWA establishes 

requirements that a State or eligible 

Indian Tribe must meet to assume and 

maintain primacy for its PWSs. Among 

others, these requirements include 


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keeping records and making reports 

available on activities that EPA requires 

by regulation. 

The reporting requirements of this 

rule ensure that EPA is notified when 

the most recent sanitary survey was 

completed, the date a system completed 

corrective action, and of systems 

providing at least 4-log treatment of 

viruses. 

The recordkeeping requirements of 

this rule ensure that States maintain 

various records to determine 

compliance with this rule. 

This section discusses these new 

requirements and the key issues raised 

by commenters on these requirements. 

1. Primacy Requirements 

The SDWA established requirements 

that a State or eligible Indian Tribe must 

meet to assume and maintain primary 

enforcement responsibility (i.e., 

primacy). These requirements include 

the following: 

• Adopting drinking water 

regulations that are no less stringent 

than Federal drinking water regulations; 

• Adopting and implementing 

adequate procedures for enforcement; 

• Keeping records on EPA-regulated 

activities and making records available; 

• Issuing variances and exemptions 

(if allowed by the State) under 

conditions no less stringent than 

allowed under the SDWA; and 

• Adopting and being capable of 

implementing an adequate plan for the 

provision of safe drinking water under 

emergency situations. 

To implement this rule, the State is 

required to adopt the following 

revisions to 40 CFR part 141: 

• § 141.21—Coliform sampling. 

• § 141.28—Certified laboratories. 

• § 141.153—Content of the reports. 

• § 141.202—Tier 1 Public Notice—

Form, manner, and frequency of notice. 

• § 141.203—Tier 2 Public Notice—

Form, manner, and frequency of notice. 

• § 141.204—Tier 3 Public Notice—

Form, manner, and frequency of notice. 

• Subpart O—Regulated 

contaminants. 

• Subpart Q—Public Notification of 

Drinking Water Violations, Appendix A, 

NPDWR Violations and Other Situations 

Requiring Public Notice. 

• Subpart Q—Public Notification of 

Drinking Water Violations, Appendix B, 

Standard Health Effects Language for 

Public Notification. 

• Subpart Q—Public Notification of 

Drinking Water Violations, Appendix C, 

List of Acronyms Used in Public 

Notification Regulation. 

• Subpart S—Ground Water Rule. 

In addition to adopting the basic 

primacy requirements specified in 40 

CFR part 142, States are required to 

address special primacy conditions 

pertaining to specific requirements 

where implementation of the rule 

involves activities beyond general 

primacy provisions. The State must 

include these regulation-specific 

provisions in an application for 

approval of their program revision. 

Under this rule, the special primacy 

conditions are in the following four 

categories: Legal Authority, Sanitary 

Surveys, Source Water Microbial 

Monitoring, and Treatment Technique 

Requirements. 

The application for approval of a State 

program revision that will adopt 40 CFR 

part 141, subpart S, must contain a 

description of how the State will 

accomplish these four program 

requirements. 

a. Legal authority. The application for 

primacy must demonstrate that the State 

has: (i) The authority contained in 

statute or regulation to ensure that 

GWSs take the appropriate corrective 

actions, including interim measures, if 

necessary, needed to address significant 

deficiencies; (ii) the authority contained 

in statute or regulation to ensure that 

GWSs conduct source water monitoring; 

(iii) the authority contained in statute or 

regulation to ensure that GWSs take the 

appropriate corrective actions, 

including interim measures, if 

necessary, to address any source water 

fecal contamination identified during 

source water monitoring; and (iv) the 

authority contained in statute or 

regulation to ensure that GWSs consult 

with the State regarding corrective 

action(s). 

b. State practices or procedures for 

sanitary surveys. In addition to the 

general requirements for sanitary 

surveys, a primacy application must 

describe how the State will implement 

a sanitary survey program and include 

an evaluation of the following eight 

sanitary survey components: source; 

treatment; distribution system; finished 

water storage; pumps, pump facilities, 

and controls; monitoring, reporting, and 

data verification; system management 

and operation; and operator compliance 

with State requirements. 

The State must conduct sanitary 

surveys that address the eight sanitary 

survey components no less frequently 

than every three years for CWSs and 

every five years for NCWS. 

The State may conduct sanitary 

surveys once every five years for CWSs 

if the system meets performance criteria 

(see Section IV.A.1). In its primacy 

application, the State must describe 

how it will determine whether a CWS 

has an outstanding performance record. 

The State must define and describe in 

its primacy application at least one 

specific significant deficiency in each of 

the eight sanitary survey elements. 

As a condition of primacy, the State 

must provide GWSs with written notice 

describing any significant deficiencies 

no later than 30 days after the State 

identifies the significant deficiency. The 

notice may specify corrective actions 

and deadlines for completion of 

corrective actions. 

c. State practices or procedures for 

source water microbial monitoring. The 

State’s primacy application must 

include a description of the following: 

(i) The criteria the State will use for 

extending the 24-hour time limit for a 

system to collect a ground water source 

sample to comply with the source water 

monitoring requirements; (ii) the criteria 

the State or GWS will use to determine 

that the cause of a total coliformpositive sample is directly related to the 

distribution system; (iii) the criteria the 

State will use for determining whether 

to invalidate a fecal indicator-positive 

ground water source sample; and (iv) 

the criteria the State will use to allow 

systems to conduct source water 

microbial monitoring at a location after 

treatment. 

d. State practices or procedures for 

treatment technique requirements. As a 

condition of primacy, the State must 

verify within 30 days after the GWS has 

reported to the State that it has 

completed corrective action that 

significant deficiencies or source water 

fecal contamination have been 

addressed either through written 

confirmation from GWSs or a site visit 

by the State. A GWS’s written notice 

may serve as this verification. The 

State’s primacy application must 

include the following: (i) Notification 

methods that the States will require 

NCWSs to use to inform the public of 

uncorrected significant deficiencies; (ii) 

the process the State will use to confirm 

that a GWS achieves at least a 4-log 

treatment of viruses; (iii) the process the 

State will use to determine the 

minimum residual disinfectant 

concentration; (iv) the State-approved 

alternative technologies to achieve at 

least 4-log treatment of viruses; (v) the 

monitoring and compliance 

requirements the State will require for 

GWSs treating to at least 4-log treatment 

of viruses; (vi) the monitoring, 

compliance and membrane integrity 

testing requirements the State will 

require to demonstrate virus removal for 

GWSs using membrane filtration 

technologies; and (vii) the criteria, 

including public health-based 

considerations and incorporating on-site 

investigations and source water 


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monitoring results, the State will use to 

determine if a GWS may discontinue 

4-log treatment of viruses. 

2. Reporting Requirements 

States are required to report 

violations, variance and exemption 

status, and enforcement actions to EPA 

according to the provisions of § 142.15. 

The final GWR adds the following three 

reporting requirements to these 

provisions (§ 142.15(c)(7)): (i) The 

month and year in which the most 

recent sanitary survey was completed, 

or for a State that uses a phased review 

process, the date that the last element of 

the applicable eight elements was 

evaluated for each GWS, (ii) the date the 

GWS completed corrective action, and 

(iii) all GWSs providing at least 4-log 

treatment of viruses for a ground water 

source. 

3. Recordkeeping Requirements 

The regulation at § 142.14 requires 

States with primacy to keep various 

records. This rule requires States to 

keep the following additional records: 

(i) Records of written notices of 

significant deficiencies; (ii) Records of 

corrective action plans, schedule 

approvals, and State-specified interim 

measures; (iii) Records of confirmations 

that a significant deficiency has been 

corrected and/or the fecal 

contamination in the ground water 

source has been addressed; (iv) Records 

of State determinations and records of 

ground water system’s documentation 

for not conducting triggered source 

water monitoring; (v) Records of 

invalidations of fecal indicator-positive 

ground water source samples; (vi) 

Records of State approvals of source 

water monitoring plans; (vii) Records of 

notices of the minimum residual 

disinfection concentrations (when using 

chemical disinfection) needed to 

achieve at least 4-log virus inactivation 

before or at the first customer; (viii) 

Records of notices of the State-specified 

monitoring and compliance 

requirements (when using membrane 

filtration or alternative treatment) 

needed to achieve at least 4-log 

treatment of viruses (using inactivation, 

removal, or a State-approved 

combination of 4-log inactivation and 

removal) before or at the first customer; 

(ix) Records of written notices from the 

GWS that it provides at least 4-log 

treatment of viruses (using inactivation, 

removal, or a State-approved 

combination of 4-log virus inactivation 

and removal) before or at the first 

customer for each ground water source; 

and (x) Records of written 

determinations that the GWS may 

discontinue 4-log treatment of viruses 

(using inactivation, removal, or a Stateapproved combination of 4-log 

inactivation and removal). 

4. What Were the Key Issues Raised by 

Commenters on the Proposed GWR 

Special Primacy, Reporting, and 

Recordkeeping Requirements for States? 

Many commenters responded to this 

request for comment and generally 

indicated that the requirements should 

be simplified and that a greater level of 

flexibility be afforded to the States. 

Commenters questioned why the 

States need to identify their approach 

and rationale for determining the fecal 

indicators to be used and commented 

that States, at their discretion, should be 

able to use any EPA-approved method. 

Commenters also felt that States should 

have the latitude to allow different 

indicators if changes in technologies or 

laboratory resources prompt an 

amendment. EPA agrees with these 

comments, and this rule does not 

include a requirement regarding 

selection of a fecal indicator. 

Some commenters believe that the 

GWR should provide specific 

information on how GWSs can achieve 

4-log removal of viruses and how States 

should evaluate treatment techniques to 

assure compliance with the rule. In 

particular, the commenters wanted more 

information and guidance on how States 

and GWSs would determine what 

disinfectant residual level or operational 

parameters (in the case of membrane 

filtration or alternative treatment 

technologies, such as UV) GWSs would 

have to maintain to ensure that the GWS 

is achieving 4-log treatment of viruses. 

The commenters indicated that 

describing in their primacy package the 

approach they will use in determining 

which specific treatment option is 

appropriate in a given circumstance will 

be an arduous task. 

EPA recognizes that selection and 

approval of a treatment technique 

option is system-specific. This rule does 

not require States to describe in their 

primacy package the approach they will 

use in determining which specific 

treatment option is appropriate in a 

given circumstance. This rule does 

require the States to describe any Stateapproved alternative technologies that 

GWSs may use to meet the treatment 

technique requirements. With regard to 

specific treatment techniques, EPA has 

recently issued the Membrane Filtration 

Guidance Manual (USEPA, 2005a) and 

is developing an ultraviolet disinfection 

guidance manual. EPA intends to 

develop a GWR Corrective Action 

guidance for further information 

regarding corrective actions and 

treatment techniques for GWSs. 

Commenters indicated that a State 

should not have to describe ‘‘how it will 

consult’’ with water suppliers regarding 

treatment requirements. EPA believes 

that the process requiring PWS 

consultation with the State prior to 

implementing corrective action is 

important in ensuring that appropriate 

corrections occur. EPA recognizes that 

States have a long history of consulting 

with water systems, so the Agency 

removed this provision from the special 

primacy requirements in this rule. 

Instead, the GWR requires that States 

identify the authority that they have to 

ensure consultation, which ensures that 

corrective actions occur, as necessary. 

G. Variances and Exemptions 

Section 1415 of the SDWA allows 

States to grant variances from NPDWRs 

under certain conditions; section 1416 

establishes the conditions under which 

States may grant exemptions to MCL or 

treatment technique requirements. 

These conditions and EPA’s view on 

their applicability to the GWR are 

summarized as follows: 

1. Variances 

Section 1415 of the SDWA specifies 

two provisions under which general 

variances to treatment technique 

requirements may be granted: 

(1) A State that has primacy may grant 

a variance to a PWS from any 

requirement to use a specified treatment 

technique for a contaminant if the PWS 

demonstrates to the satisfaction of the 

State that the treatment technique is not 

necessary to protect public health 

because of the nature of the PWS’s raw 

water source. EPA may prescribe 

monitoring and other requirements as 

conditions of the variance (section 

1415(a)(1)(B)). 

(2) EPA may grant a variance from any 

treatment technique requirement upon a 

showing by any person that an 

alternative treatment technique not 

included in such requirement is at least 

as efficient in lowering the level of the 

contaminant (section 1415(a)(3)). 

EPA does not believe that the variance 

provision under the SDWA at 

1415(a)(1)(B) is applicable to GWSs 

under this rule. As discussed above, the 

regulation employs a targeted approach 

whereby corrective action is required 

only for those systems that have the 

most risk ‘‘ those systems that have 

found fecal contamination in their 

source water as indicated by source 

water monitoring, or have been found to 

be susceptible to contamination as 

indicated by a significant deficiency 

from a sanitary survey. Thus, the 

treatment technique requirements 

account for the nature of the PWS raw 


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water source. The GWR does not require 

the use of disinfection, nor does it 

compel the system to address the raw 

water source if, for example, an 

alternate source of drinking water is 

available. 

With respect to the variances 

authorized under 1415(a)(3), EPA notes 

that this provision is unlikely to be used 

because the four treatment techniques 

provided in the GWR cover a broad 

range of options and States can approve 

any alternative treatment technologies. 

Given this broad range of treatment 

technique options, it is unlikely that a 

system could demonstrate to EPA that 

an alternative treatment technique not 

included in the regulation is at least as 

efficient in lowering the level of the 

contaminant of concern. 

Section 1415(e) of the SDWA 

describes small PWS variances, but 

these cannot be granted for a treatment 

technique for a microbial contaminant. 

Hence, small PWS variances are not 

allowed for the GWR. 

2. Exemptions 

Under SDWA section 1416(a), a State 

may exempt any PWS from a treatment 

technique requirement upon a finding 

that (1) due to compelling factors 

(which may include economic factors 

such as qualification of the PWS as 

serving a disadvantaged community), 

the PWS is unable to comply with the 

requirement or implement measures to 

develop an alternative source of water 

supply; (2) the PWS was in operation on 

the effective date of the treatment 

technique requirement, or for a PWS 

that was not in operation by that date, 

no reasonable alternative source of 

drinking water is available to the new 

PWS; (3) the exemption will not result 

in an unreasonable risk to health; and 

(4) management or restructuring 

changes (or both) cannot reasonably 

result in compliance with the Act or 

improve the quality of drinking water. 

EPA believes that granting an 

exemption to the treatment 

requirements of the GWR would result 

in an unreasonable risk to health. As 

described in section III.C, microbial 

contamination causes acute health 

effects, which may be severe in sensitive 

subpopulations. Moreover, the 

additional treatment requirements of the 

GWR are targeted to PWSs with the 

highest degree of risk. Due to these 

factors, EPA does not support the 

granting exemptions from the GWR. 

V. Explanation of Extent of GWR 

A. Mixed Systems 

This rule applies to PWSs (CWSs and 

NCWSs) that use ground water in whole 

or in part (except GWUDI systems), 

unless all ground water is commingled 

with surface water before treatment at 

the surface water treatment plant is 

applied, in which case surface water 

treatment regulations apply. This means 

that the treatment technique 

requirements of the GWR for significant 

deficiencies apply to any system using 

both ground water and surface water 

that has a significant deficiency 

identified past the point of surface water 

treatment, unless the State determines 

that the significant deficiency is in a 

portion of the system served solely by 

surface water. EPA believes that the 

same level of public health protection 

provided by this rule to persons served 

solely by ground water must be 

provided to persons served by ground 

water supplies in mixed systems. 

EPA received comments regarding the 

applicability of the proposed GWR to 

systems that serve both ground water 

and surface water. Commenters noted 

that the requirements for these ‘‘mixed 

systems’’ were not explicit for the 

individual rule components such as 

sanitary surveys and triggered source 

water monitoring. For example, 

commenters specifically noted that the 

proposed GWR did not address how to 

conduct the triggered source water 

monitoring requirement after a total 

coliform-positive under the TCR was 

detected in systems where ground water 

and surface water are blended in the 

distribution system. 

EPA has included more explicit 

regulatory language that describes how 

‘‘mixed systems’’ must comply with 

individual components of this rule to 

assist PWSs in understanding and 

implementing the GWR provisions. 

There are approximately 3,700 mixed 

systems in the U.S. This rule explicitly 

addresses general applicability and the 

applicability of specific GWR 

components to mixed systems. The 

complexity and variety of configurations 

and operations in these mixed systems 

do not allow for all the possible 

scenarios to be addressed within a 

regulatory framework, so States will 

have the discretion to make a sitespecific determination whether a 

significant deficiency is in a portion of 

the system served solely by surface 

water. 

EPA will provide further information 

through implementation guidance and 

other non-regulatory approaches to 

assist States and water systems in 

meeting the intent of this rule, to target 

GWSs that are at risk of fecal 

contamination and to require these 

systems to take corrective action to 

protect public health. In some cases, it 

may be possible to identify customers or 

portions of the distribution system in 

mixed systems served solely by surface 

water or ground water. In other cases, it 

may not be possible or may be transitory 

due to complex and/or variable system 

hydraulic conditions. 

B. Cross-Connection Control 

EPA is concerned about fecal 

contamination entering distribution 

systems; however, cross-connection 

control requirements are not a part of 

this rule, though the proposal contained 

cross-connection consideration. The 

Stage 2 Microbial and Disinfection 

Byproducts Federal Advisory 

Committee’s Agreement in Principle (65 

FR 83015, December 2000) (USEPA, 

2000b) states that cross-connections and 

backflow in distribution systems 

represent a significant public health risk 

and that EPA should initiate a process 

to address cross-connection control and 

backflow prevention requirements as 

part of the six-year review of the TCR. 

EPA has published its intent to consider 

such requirements as part of the 

revisions to the TCR (67 FR 19030, April 

17, 2002) (USEPA, 2002b). 

VI. Implementation 

This section describes the regulations 

and other procedures and policies that 

States must adopt, as well as the 

requirements that public GWSs would 

have to meet to implement this rule. 

Also discussed are the compliance 

deadlines for these requirements. 

States must continue to meet all other 

conditions of primacy at 40 CFR part 

142. Section 1413(a)(1) of the 1996 

SDWA Amendments provides two years 

(plus more time if the Region approves) 

after promulgation of the final GWR for 

the State to adopt drinking water 

regulations that are no less stringent 

than the final GWR in order to obtain 

primacy for the GWR. 

GWSs must continue to meet all other 

applicable requirements of 40 CFR part 

141. The SDWA as amended in 1996 

(see section 1412(b)(10)) provides three 

years after promulgation for compliance 

with new regulatory requirements. 

Accordingly, the GWR requirements 

that apply to the PWS directly, 

specifically the requirements found 

under subpart S of 40 CFR part 141 

(source water monitoring, corrective 

actions and treatment technique 

requirements, compliance monitoring, 

recordkeeping and reporting, and public 

notice and public information), take 

effect three years after promulgation. 

The State may, in the case of an 

individual system, provide additional 

time of up to two years for capital 

improvements, if necessary, in 

accordance with the statute. 


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This rule includes conditions of 

primacy at 40 CFR part 142 under 

which States will have until December 

31, 2012 to complete the initial sanitary 

survey cycle for CWSs, except those 

meet performance criteria, and until 

December 31, 2014 to complete the 

initial sanitary survey cycle for all 

NCWSs and CWSs that meet 

performance criteria (refer to Section 

IV.A.1 for criteria). These sanitary 

survey implementation deadlines 

provide time for States to adopt the rule 

and obtain primacy (two to four years 

allowed by the SDWA at 1413(a)(1)). In 

addition, systems are given three years 

to comply with drinking water 

regulations by the SDWA at 

(1412(b)(10)). Finally, States need three 

to five years to complete the first cycle 

of sanitary surveys because there are 

many GWSs and States have limited 

resources. 

The GWR places the same sanitary 

survey frequency requirements on 

GWSs as is currently required of surface 

water systems under 40 CFR part 141 

subpart H. 

GWSs must comply with all 

applicable requirements beginning 

December 1, 2009 unless otherwise 

noted. 

VII. Economic Analysis (Health Risk 

Reduction and Cost Analysis) 

This section summarizes the Health 

Risk Reduction and Cost Analysis 

(HRRCA) in support of the final GWR. 

This analysis has been revised and 

updated from the HRRCA prepared for 

the proposal as required by section 

1412(b)(3)(C) of the SDWA. In addition, 

under Executive Order 12866, 

Regulatory Planning and Review, EPA 

must estimate the costs and benefits of 

this rule in an Economic Analysis (EA). 

EPA has prepared an EA (USEPA, 

2006d) to comply with the requirements 

of this order and to update the SDWA 

HRRCA. The EA document for the GWR 

is available in the docket and is also 

published on the government’s Web site 

http://www.regulations.gov. 

The HRRCA consists of seven 

elements as follows: (1) Quantifiable 

and nonquantifiable health risk 

reduction benefits; (2) quantifiable and 

nonquantifiable health risk reduction 

benefits from reductions in co-occurring 

contaminants; (3) quantifiable and 

nonquantifiable costs that are likely to 

occur solely as a result of compliance; 

(4) incremental costs and benefits of 

rule alternatives; (5) effects of the 

contaminant on the general population 

and sensitive subpopulations including 

infants, children, pregnant women, 

elderly, and immunocompromised; (6) 

increased health risks that may occur as 

a result of compliance; and (7) other 

relevant factors such as uncertainties in 

the analysis. A summary of these 

elements is provided in this section of 

the preamble, and a complete 

discussion can be found in the GWR EA 

(USEPA, 2006d). 

Both the benefits and the costs 

discussed in this section are presented 

as annualized present values in 2003 

dollars. This process allows comparison 

of cost and benefit streams that are 

variable over a given time period and 

differs from the GWR proposal (USEPA, 

2000a), which only used an annual 

estimate. The time frame used for both 

benefit and cost comparisons in this 

rule is 25 years. This time interval 

accounts for early rule implementation 

activities (e.g., States adopting the 

criteria of the regulation) and the time 

for different types of compliance actions 

to be realized up through year 25 

following rule promulgation (e.g., 

identification and correction of sanitary 

survey deficiencies, identification of 

wells that are fecally contaminated and 

subsequent corrective action). The 

Agency uses social discount rates of 

both three percent and seven percent to 

calculate present values from the stream 

of benefits and costs and also to 

annualize the present value estimates. 

The GWR EA (USEPA, 2006d) also 

shows the undiscounted stream of both 

benefits and costs over the 25 year time 

frame. 

The quantified benefits are calculated 

based only on endemic, acute disease 

illness, and death from some viral, but 

not bacterial, contamination of PWS 

wells. EPA was able to monetize only 

this subset of total benefits which were 

compared to the total costs of this rule. 

The total benefits, both quantified and 

nonquantified, are estimated using 

illness and death data as well as nonhealth benefits such as avoided costs 

(e.g., restaurant closures) due to 

outbreaks. Furthermore, the total health 

benefits are estimated based on a full 

range of health effects, including acute 

and chronic illness and endemic and 

epidemic disease from both bacteria and 

virus contamination. EPA believes that 

the quantified benefits for this rule 

underestimate reduction in risk because 

the Agency was only able to calculate a 

subset of the total benefits; peer 

reviewers of the GWR benefit analysis 

agree that the quantified benefits are 

biased low. The costs of the rule stem 

mostly from the sanitary survey and the 

correction of significant deficiencies as 

well as the triggered source water 

monitoring and corrective action 

provisions described earlier in this 

preamble. 

This section of the preamble includes 

12 elements as follows: (A) Rationale for 

choosing a different alternative from the 

proposed alternative, (B) occurrence and 

risk analyses that support this rule, (C) 

both quantified and nonquantified 

benefits, (D) both quantified and 

nonquantified costs, (E) potential 

impact on households, (F) incremental 

costs and benefits, (G) benefits from 

simultaneous reduction of co-occurring 

contaminants, (H) increases in risk due 

to other contaminants, (I) effects on the 

general population and special 

subgroups, (J) uncertainties in risk, 

benefit, and cost estimates, (K) benefit/ 

cost determination, and (L) major 

comments and responses. Section VII.F 

presents the benefits and costs for the 

four regulatory alternatives that were 

considered in this rule. Table VII–1 

provides a summary of monetized 

benefits and costs for each GWR 

regulatory alternative. 

TABLE VII–1.—MONETIZED BENEFITS AND COSTS FOR GWR REGULATORY ALTERNATIVES

[Millions, 2003$] 

Rule alternative 

3% Discount rate 7% Discount rate 

Mean 5th–95th 

Percentiles Mean 5th–95th Percentiles 

National GWR Benefits 

Enhanced COI: 

Risk-Targeted Approach ........................................................................... $19.7 $6.5–$45.4 $16.8 $5.5–$38.6 

Sanitary Survey ........................................................................................ 3.6 0.9–9.3 2.9 0.7–7.5 

Multi-barrier Approach .............................................................................. 21.3 7.1–48.7 18.2 6.0–41.6 


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TABLE VII–1.—MONETIZED BENEFITS AND COSTS FOR GWR REGULATORY ALTERNATIVES—Continued 

[Millions, 2003$] 

Rule alternative 

3% Discount rate 7% Discount rate 

Mean 5th–95th 

Percentiles Mean 5th–95th Percentiles 

Across the Board Disinfection .................................................................. 70.2 18.3–177.0 61.9 16.1–156.3 

Traditional COI: 

Risk-Targeted Approach ........................................................................... 10.0 2.2–27.0 8.6 1.9–22.9 

Sanitary Survey ........................................................................................ 1.9 0.3–5.5 1.5 0.2–4.5 

Multi-barrier Approach .............................................................................. 10.8 2.5–28.9 9.3 2.1–24.8 

Across the Board Disinfection .................................................................. 35.5 6.5–102.4 31.5 5.7–90.8 

National GWR Costs 

Risk-Targeted Approach .................................................................................. 61.8 45.2–81.4 62.3 46.1–81.6 

Sanitary Survey ............................................................................................... 15.3 11.8–19.2 15.3 11.9–19.0 

Multi-barrier Approach ..................................................................................... 67.9 49.4–89.5 69.4 51.0–90.6 

Across the Board Disinfection ......................................................................... 686.4 636.8–735.4 665.3 612.3–717.0 

A. How Has the Final Rule Alternative 

Changed From the Proposed Rule 

Alternative? 

The primary elements of the GWR 

alternative that EPA proposed were 

sanitary surveys, triggered source water 

monitoring, hydrogeologic sensitivity 

analyses (HSAs), routine monitoring, 

corrective action, and compliance 

monitoring. This alternative was termed 

‘‘multi-barrier approach.’’ After the 

proposal, EPA considered comments 

received as discussed in section II.C of 

this preamble. This review resulted in 

the Agency choosing a different final 

rule alternative, Alternative 2, or the 

‘‘risk-targeted approach.’’ EPA believes 

that the final rule is a logical outgrowth 

of the proposed rule, that it is supported 

by comments, and that it provides 

public health benefits while 

apportioning costs in a more flexible 

targeted manner. 

EPA continues to believe that the 

elements of the multi-barrier approach 

are important. At first, EPA attempted to 

redesign the multi-barrier approach to 

resolve the issues raised by commenters. 

In this redesigned structure, HSAs were 

optional and routine monitoring 

(renamed assessment source water 

monitoring) was a required up-front 

monitoring program limited to 1 year of 

monthly samples. EPA has estimated 

the costs and benefits for this variation 

of the multi-barrier approach in the final 

EA (Alternative 3). However, EPA 

ultimately determined that the structure 

of this variation of the multi-barrier 

approach was too restrictive to achieve 

the full potential benefits of an 

assessment source water monitoring 

program. In addition, it did not provide 

sufficient flexibility to States, which 

was a major theme of the comments 

EPA received. Therefore, EPA decided 

to redesign the source water monitoring 

provision by making assessment source 

water monitoring an option that States 

can require as they see fit. The purpose 

of this optional requirement is to target 

source water monitoring to systems that 

the States believe are at a higher risk for 

microbial contamination. EPA believes 

that States are in the best position to 

assess which systems would most 

benefit from a comprehensive source 

water monitoring program. EPA 

recommends that States use HSAs as 

one tool to identify high risk systems for 

assessment source water monitoring. 

The risk-targeted approach of the final 

rule contains sanitary surveys, triggered 

source water monitoring, optional 

assessment source water monitoring, 

corrective action, and compliance 

monitoring. 

For the Economic Analysis of the final 

rule alternative, EPA did not include 

potential costs and benefits of 

assessment source water monitoring. 

This is because assessment source water 

monitoring is an optional requirement 

under the final GWR. Thus, the EA 

considers quantified costs and benefits 

only of sanitary surveys, triggered 

source water monitoring, corrective 

action, and compliance monitoring. 

Throughout the EA, the final rule 

alternative is listed as Alternative 2—

the risk-targeted approach. A discussion 

of the costs and benefits for the 

regulatory alternatives considered may 

be found in Chapter 8 of the EA 

(USEPA, 2006d). 

B. Analyses That Support This Rule 

EPA estimates national viral and fecal 

indicator occurrence based on data from 

several studies. The following 

discussion summarizes EPA’s 

occurrence and risk analyses that 

support this rule. 

1. Occurrence Analysis 

a. Study selection. As discussed in 

Section III.C.3 of this preamble and in 

the NODA, EPA examined data from 24 

studies of pathogen and fecal indicator 

occurrence in ground water wells that 

supply PWSs (USEPA, 2006e). EPA 

selected 15 of these studies to use in the 

risk assessment analysis to estimate 

national viral and fecal indicator 

occurrence in ground water. The 

Occurrence and Monitoring Document 

for the Final Ground Water Rule 

(USEPA, 2006b) provides a detailed 

discussion of each occurrence study 

evaluated. 

To assist study selection and 

occurrence modeling, EPA convened a 

two-day statistical workshop in May 

2005. The core workgroup included 

expert participants from several 

government agencies and private 

consulting firms working as U.S. 

government advisors. A summary of the 

workgroup proceedings, including a list 

of all participants, is included in the 

final docket for this rulemaking. The 

charge to the workgroup was to consider 

how to improve modeling of viral and 

indicator occurrence. The statisticians 

strongly recommended that EPA make 

use of all the available data unless there 

were known quality assurance problems 

with a data set or the well 

contamination scenario was outside the 

normal operating range of U.S. PWS 

wells. 

After the workshop, EPA followed 

through on the workgroup’s 

recommendations and used all available 

data sets having enterovirus and fecal 

indicator occurrence in ground water 

source(s) from PWS wells in the United 

States with some exceptions. Of the 16 

studies described in the proposed GWR, 

EPA did not use data from five studies 

to inform the national occurrence 


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estimates for this rule. EPA did not use 

the data set of alluvial wells from 

Missouri that were substantially affected 

by severe Mississippi River flooding 

(Vaughn, 1996). Data from a California 

study (Yates et al., 1999) were deleted 

from further consideration because data 

were available only by well and not by 

sample, so the probability of viruses 

detected by individual assays could not 

be assessed. Data from the Whittier, 

California study (Yanko et al., 1999) 

were not used because the study author, 

in comment on the proposal, suggested 

that the observed somatic coliphage 

occurrence was not due to fecal 

contamination. EPA did not use data 

from Honolulu, Hawaii (Fujioka and 

Yoneyama, 2001) because the wells 

were not sampled for pathogenic viruses 

and because E. coli are endemic in 

tropical ecosystems and not simply 

indicators of fecal origin. EPA did not 

use data from the U.S.-Mexico Border 

study because the human virus data 

were never reported in written form. 

Of the seven studies that became 

available since proposal and described 

in the NODA, EPA did not use four 

studies to inform national occurrence 

estimates. EPA did not use the data from 

the set of wells developed by Karim et 

al. (2003; 2004), because these 20 wells 

are also included in Abbaszadegan et al. 

(2003). EPA did not have sufficient 

information to distinguish which of the 

20 wells from Karim (2003; 2004) were 

the same wells from Abbaszadegan et al. 

(2003) and, therefore, only used the 

larger data set. EPA did not use the 

National Field Study data (USEPA, 

2006f) because the data set includes 

both PWS and domestic wells, and 

insufficient information is available to 

identify which wells are PWS wells. 

Also, the National Field Study data set 

(USEPA, 2006f) included virus cell 

culture measurements using smaller 

sample volumes than all of the other 

data sets. EPA did not use data from La 

Crosse, Wisconsin (Borchardt et al., 

2004) because this was a small study of 

four wells (and two other wells sampled 

once only) in one locality which, 

although not regulated as GWUDI, were 

under investigation to determine if that 

regulatory determination was correct. 

EPA did not use data from another small 

study of two wells in Missoula, 

Montana because of the size of the data 

set. In addition, EPA added one study 

of 38 wells from Helena, Montana that 

was submitted to EPA in response to the 

NODA. 

b. Description of occurrence data used 

to characterize national viral and 

indicator occurrence. Table VII–2 shows 

the 15 studies used to inform national 

occurrence estimates for viruses and 

indicators. One data set (Lieberman et 

al., 2002), targeted wells based on 

presence of total coliforms and other 

indicators of vulnerability to fecal 

contamination. Another data set 

(Abbaszadegan et al., 2003), targeted a 

representation of wells throughout the 

United States based on hydrogeological 

conditions, but excluded any wells that 

were poorly constructed, ground water 

under the direct influence of surface 

water (GWUDI), or without well logs. 

Other studies sampled a subset of wells 

in a particular State, region, or 

hydrogeological setting. Most of the 

studies were designed to capture subsets 

of the total PWS well population. EPA 

excluded data from wells that States had 

identified as being GWUDI. Only a 

couple of the studies included such 

wells in their sample set (Lieberman et 

al., 2002, Atherholt et al., 2003). PWS 

using wells with GWUDI are required to 

meet the same treatment technique 

requirements for pathogens that pertain 

surface water supplies and are not 

subject to the requirements of this rule. 

EPA’s analysis to develop national 

estimates for virus and indicator 

frequency of occurrence in wells made 

no attempt to weight any of the studies 

to compensate for any perceived overor under-representation of the subset as 

compared with the total population. 

TABLE VII–2.—LIST OF STUDIES USED

IN NATIONAL OCCURRENCE ANALYSIS

Lieberman et al., 2002 (multiple States). 

Abbaszadegan, et al., 2003 (multiple States). 

Lindsey et al., 2002 (Pennsylvania Non-community Wells). 

Francy et al., 2004 (Southeast Michigan). 

Atherholt et al., 2003 (New Jersey). 

Davis and Witt, 2000 (Missouri Ozark Plateau #1). 

Femmer, 2000 (Missouri Ozark Plateau #2). 

USEPA et al., 1998d (Wisconsin Migrant 

Worker Camp). 

Doherty, 1998 (New England). 

Battigelli, 1999 (Three-State Study: Wisconsin). 

Banks et al., 2001 (Three-State Study: Maryland). 

Banks and Battigelli, 2002 (Three-State 

Study: Maryland). 

Minnesota DOH, 2000 (Three-State Study: 

Minnesota). 

USEPA, 1998a (EPA Vulnerability Study). 

Miller and Meek, 2006 (Montana). 

Using enterovirus cell culture and E. 

coli data from the 15 studies, EPA 

modeled virus and fecal indicator (E. 

coli) occurrence in ground water. EPA 

believes that enterovirus cell culture 

measurements provide the best available 

basis for estimating pathogenic viral 

occurrence since it captures viruses that 

are alive and infectious. However, 

because the cell culture procedure only 

captures a portion of the types of 

pathogenic viruses that may actually 

occur in well water, use of this metric 

underestimates total viral occurrence. 

EPA did not use PWS samples assayed 

using PCR methods to estimate national 

viral occurrence for this rule because 

PCR methods cannot discriminate 

between infectious and non-infectious 

viruses. Three of the 15 studies 

included viral concentration data 

(Lieberman et al., 2002, Abbaszadegan, 

et al., 2003 and Lindsey et al., 2002). 

EPA used data from these studies to 

inform national estimates for viral 

concentrations among wells modeled to 

have viral occurrence. However, since 

the sampling sites from Lieberman et 

al., 2002 were selected because they had 

a history of total coliform contamination 

or other evidence of vulnerability 

(whereas the sample sites from the other 

two studies had no such site selection 

bias), EPA only used viral concentration 

data from Lieberman et al., 2002 for a 

small portion of wells in the U.S. 

EPA used data on the indicator E. coli 

to inform estimates of fecal 

contamination occurrence. Indicator 

data is important because illness can 

result from consuming ground water 

with fecal contamination in the absence 

of identified viruses. EPA chose to use 

E. coli as the indicator organism to 

inform national fecal contamination 

occurrence for several reasons. First, 

analysis using two or more indicator 

organisms becomes increasingly 

complex. Second, substantial variability 

among studies in choice of indicators, 

indicator assay method, sample volumes 

and, in the case of coliphage, bacterial 

host and host range, adds uncertainty 

when data sets are combined. Third, for 

any one indicator other than E. coli, the 

number of assays with consistency of 

measurement is small. Fourth and most 

important, EPA believes that E. coli will 

be the most likely fecal indicator used 

when PWS implement the GWR and 

therefore national estimates of E. coli 

occurrence can be used to inform 

potential cost implications for 

implementing the GWR. 

c. How data were used to estimate 

national occurrence of viral and fecal 

contamination. Data from each of 15 

studies were combined into one single 

data set used to determine the 

probabilities of wells having anytime 

viral (indicated by enterovirus cell 

culture) or fecal indicator (indicated by 

E. coli) contamination. The results of 

this effort led naturally to a combined 

analysis, which also modeled cooccurrence of viruses and E. coli. This 

combined model serves as the basis of 

EPA’s national quantitative occurrence 

estimates. 


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EPA’s occurrence model includes four 

categories of wells: 

• Wells with no E. coli occurrence, 

but some virus occurrence, 

• Wells with both E. coli and virus 

occurrence, 

• Wells with no virus, but some E. 

coli occurrence, and 

• Wells with neither E. coli nor virus 

occurrence. 

The fractions of wells falling into 

these four categories are named P1, P2, 

P3, and P4, respectively. The categories 

and parameters P1 through P4 are 

illustrated in the Venn diagram of 

Figure VII–1. 

Because fecal contamination is 

intermittent, viruses and E. coli will 

only be present some fraction of time in 

a contaminated well. These fractions 

will vary from well to well and EPA has 

modeled these different fractions as 

distributions. One parameter pair 

describes the distribution for viruses 

and another parameter pair describes 

the distribution for E. coli. These four 

parameters, together with the fractions 

of wells falling into the four categories, 

are the parameters estimated in the 

national occurrence model. 

The Economic Analysis for the Final 

Ground Water Rule describes the 

statistical methods used to estimate 

model parameters (USEPA, 2006d). That 

document details the statistical model, 

estimation methods, and summary 

results. The GWR EA also includes a 

number of Exhibits that describe the 

central estimates (means) and their 

uncertainties. 

Central estimates for key parameters 

are as follows: 

• P1 = percentage of wells having 

virus, but no E. coli = 10 percent 

• P2 = percentage of wells having 

both virus and E. coli = 16 percent 

• P3 = percentage of wells having E. 

coli, but no virus = 10 percent 

• P4 = percentage of wells having no 

virus and no E. coli = 64 percent 

• On average, wells with some virus 

occurrence have detectable 

concentrations 11 percent of the time. 

• On average, wells with some E. coli 

occurrence have detectable 

concentrations 14 percent of the time. 

EPA attempted to evaluate occurrence 

based on the hydrogeologic 

characteristics of the aquifer. However, 

because very few data sets allowed for 

differentiation of viral or indicator 

presence among sensitive versus nonsensitive wells, no significant difference 

in viral or indicator presence could be 

discerned from the limited data. 

Therefore, the same P1, P2, P3, and P4 

estimates were assumed for all wells, 

without regard to aquifer sensitivity. 

Although EPA could not stratify the 

available viral occurrence data between 

wells drawn from sensitive or nonsensitive aquifers, EPA was able to 

discern two classifications of well type 

according to overall vulnerability 

characteristics (more and less 

vulnerable wells). The data from 

Lieberman et al., 2002 were used to 

represent virus concentrations in more 

vulnerable wells and the combined data 

from Abbaszadegan et al., 2003 and 

Lindsey et al., 2002 were used to 

represent concentrations in less 

vulnerable wells. 

EPA used acute and non-acute TCR 

maximum contaminant level (MCL) 

violation data to estimate the percent of 

wells considered more vulnerable. 

Based on this data, EPA estimated that 

about 2.5 percent of wells in the U.S., 

which have modeled viral presence, 

would have viral concentrations like the 

non-GWUDI wells in Lieberman et al., 

2002 (more vulnerable). Similarly, EPA 

estimated that about 97.5 percent of the 

wells in the U.S. (100—2.5 percent) 

which have modeled viral presence 

would have concentrations like those of 

Abbaszadegan et al. (2003) and Lindsey 

et al. (2002) (less vulnerable). 

2. Risk Analyses 

a. Baseline risk estimates. The 

framework for developing the estimates 

of baseline risk from consumption of 

contaminated ground water is in 

accordance with the standard 

framework detailed in the EPA Policy 

for Risk Characterization (USEPA, 

1995a), EPA’s Guidance for Risk 

Characterization (USEPA, 1995b), and 

EPA’s Policy for Use of Probabilistic 

Analysis in Risk Assessment (USEPA, 


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65618 Federal Register / Vol. 71, No. 216 / Wednesday, November 8, 2006 / Rules and Regulations 

1997c). A complete discussion of EPA’s 

risk analyses in support of this rule can 

be found in the GWR EA (USEPA, 

2006d). The discussion below is an 

overview of the analyses, focusing on 

how information on occurrence, 

exposure, and dose-response is 

combined to produce estimates of health 

risk. 

EPA’s occurrence model predicts the 

fraction of wells that have some degree 

of viral contamination. The model also 

predicts degree of contamination, in 

terms of the varying fractions of time 

that viruses can be detected. In the 

probabilistic risk analysis, Monte Carlo 

techniques are used to simulate large 

numbers of wells with differing 

fractions of time that virus is present. 

In addition to assigning different 

fractions of time, the risk model also 

assigns different concentration levels to 

the simulated contaminated wells. Each 

well is assigned one concentration value 

and this is treated as the well’s 

concentration whenever the well has 

virus present. EPA does this by 

sampling from the actual virus 

concentrations that were observed in the 

occurrence studies. Viral concentrations 

among more vulnerable wells are 

sampled from the measured values of 

non-GWUDI wells in the Lieberman et 

al., 2002, study. Concentrations in less 

vulnerable wells are sampled from those 

measured in the Abbaszadegan, et al., 

2003 and Lindsey et al., 2002 studies. 

EPA’s risk model then estimates 

exposure levels, or doses, for consumers 

of the contaminated well water. A 

consumer’s dose on a day when virus is 

present depends on the virus 

concentration, the level of disinfection 

employed by the water system, and the 

volume of tap water that the consumer 

ingests. For systems that do not 

disinfect, the tap water is assumed to 

have the same virus concentration as the 

source water. In contrast, properly 

operating systems that disinfect are 

assumed to inactivate 99 percent (2-log) 

to more than 99.99 percent (4-log) of 

viral pathogens, depending on the 

disinfection practices employed. A 

consumer’s daily dose is computed as 

the product of the tap water 

concentration, the fraction of viral 

pathogens NOT inactivated and the 

volume of water ingested. 

Next, the consumer’s daily dose is 

translated to risk of infection via EPA’s 

dose-response modeling. EPA’s risk 

model applies the calculated dose, 

based on viral cell culture measurement, 

for both Type A and Type B viruses. 

Daily probabilities of infection are then 

derived on the basis of the daily dose, 

according to dose-response models. 

Annual probabilities of infection are 

then derived from the daily estimates, 

based on the number of days per year 

in which a virus is expected to be 

present. 

Next, morbidity factors (risk of illness 

given infection), secondary spread of 

illness to other individuals, and 

mortality factors (risk of premature 

death given an illness), derived from the 

literature, are used to estimate the 

annual probability for illness and 

premature death. EPA’s risk assessment 

model includes variability and 

uncertainty ranges for morbidity and 

mortality to account for different effects 

in different subpopulations. 

b. Risk reduction estimates. The 

methodology for estimating the 

reduction in risk for the regulatory 

alternatives builds upon the approach 

and assumptions used to establish the 

baseline risk. The primary difference 

between the modeling for estimating the 

baseline risk model and the modeling 

for estimating the risk reduction from a 

given regulatory alternative is that the 

latter incorporates a change in the 

concentration of viral pathogens 

reaching the finished drinking water of 

the exposed population. These changes 

reflect either a reduction in pathogen 

concentration between source water and 

finished water due to disinfection or the 

elimination of the pathogen from other 

non-treatment corrective actions 

addressing the source water 

contamination. In addition to 

accounting for the magnitude of 

pathogen exposure reduction, an 

important component of the risk 

reduction modeling is to account for the 

timing of when those reductions occur 

over a 25 year analysis timeframe 

following promulgation of the rule. 

For the baseline risk analysis, each 

well in the simulation process is 

designated as either having a virus 

present at some time or never having a 

virus present. For those wells having 

some viral occurrence, values are 

assigned for the virus concentration and 

the fraction of time that virus occurs. 

The risk reduction part of the model 

uses the exact same simulated wells as 

those generated in the baseline risk part 

of the model. 

For the sake of efficiency in 

implementing the simulation modeling 

process, those wells designated as never 

having a virus present are recognized as 

having zero risk reduction potential and 

are counted as such in the model 

outputs, but are not run through the 

detailed steps of the risk reduction 

model. 

For those wells that do have a virus 

present, the risk reduction model 

answers the following three questions: 

(1) Is a corrective action performed on 

this well as a result of the regulatory 

alternative being considered? 

(2) What is the finished water virus 

concentration following corrective 

action? 

(3) In what year following rule 

implementation is the corrective action 

performed? 

The risk reduction model then 

processes the reduced virus 

concentrations through the doseresponse functions for infectivity and 

the morbidity and mortality factors as in 

the baseline risk assessment. 

Estimates of cases avoided, calculated 

for all of the individual wells, are then 

aggregated across all wells to arrive at 

the total national estimates of risk 

reduction. In addition, some of the 

assumptions and data used in the risk 

reduction model are uncertain and are 

therefore input as uncertainty 

distributions. As a result of the 

uncertainty reflected in those inputs, 

together with the uncertainty reflected 

in other inputs to the baseline risk 

model that are also carried into the risk 

reduction model, the output of the 

model is a range of values of cases 

avoided. The range is used by EPA to 

determine the expected value and the 90 

percent confidence bounds on that 

expected value. 

The GWR EA (USEPA, 2006d) 

describes in more detail the specific 

assumptions and inputs—including 

considerations of uncertainty—that are 

used to model risk reduction for each of 

the four rule options at the individual 

well level and the aggregation of those 

well level estimates to obtain the overall 

national estimates of risk reduction. 

C. What Are the Benefits of the GWR? 

The quantified benefits of this rule 

result from reductions in endemic acute 

viral illness and death from two groups 

of viruses (called Type A and Type B). 

Type A virus is represented by rotavirus 

and is highly infectious but has 

essentially only mild health effects. 

Type B virus is represented by 

enterovirus or echovirus (a member of 

the enterovirus group) and is 

moderately infectious, but can have 

severe health consequences though the 

majority of illnesses from Type B 

viruses are also mild. Additionally, the 

quantified benefits are based only on 

endemic, acute illness that occurs as a 

result of virus in PWS wells under 

normal operating conditions. Illnesses 

due to treatment interruptions or 

failures or to distribution system 

deficiencies are not quantified. Bacterial 

illnesses and deaths avoided are also 

not quantified. 


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As shown in Table VII–3 below, the 

annualized present value of the 

quantified benefits of this rule are $19.7 

million (using a three percent discount 

rate and an enhanced cost-of-illness 

value that includes lost unpaid labor 

(e.g., household production) and leisure 

time for people within and outside the 

paid labor force), with a 90 percent 

confidence interval of $6.5 to $45.4 

million. Using traditional cost-of-illness 

values at the same discount rate, the 

annualized present value of the 

quantified benefits of the rule are $10.0 

million, with a 90 percent confidence 

interval of $2.2 to $27.0 million. At a 

seven percent discount rate and the 

enhanced cost-of-illness value, the 

annualized present value of the 

quantified benefits are $16.8 million, 

with a 90 percent confidence interval of 

$5.5 to $38.6 million. Using the 

traditional cost-of-illness values, the 

annualized present value of the 

quantified benefits are $8.6 million, 

with a 90 percent confidence interval of 

$1.9 to $22.9 million at a seven percent 

discount rate. 

TABLE VII–3.—SUMMARY OF ANNUALIZED PRESENT VALUE QUANTIFIED BENEFITS

[$Millions, 2003$] 

System type 

Annualized benefits at three percent 

discount rate 

Annualized benefits at seven percent 

discount rate 

Mean 

90 Percent confidence bound 

Mean 

90 Percent confidence bound 

Lower 

(5th %ile) 

Upper 

(95th %ile) 

Lower 

(5th %ile) 

Upper 

(95th %ile) 

Enhanced COI: 

CWSs ................................................................ $16.0 $5.4 $37.0 $13.7 $4.6 $31.6 

NTNCWSs ........................................................ 0.9 0.3 2.2 0.8 0.2 1.8 

TNCWSs ........................................................... 2.7 0.8 6.2 2.3 0.7 5.1 

Total ........................................................... 19.7 6.5 45.4 16.8 5.5 38.6 

Traditional COI: 

CWSs ................................................................ 8.2 1.9 22.3 7.1 1.6 19.1 

NTNCWSs ........................................................ 0.5 0.1 1.3 0.4 0.1 1.0 

TNCWSs ........................................................... 1.3 0.3 3.4 1.1 0.2 2.8 

Total ........................................................... 10.0 2.2 27.0 8.6 1.9 22.9 

Note: Estimates are derived from independent model runs and, therefore, detail may not add to total. Values are for endemic viral illnesses 

and deaths avoided over the 25-year period, expressed in annualized dollars. See VII.C.4 for additional rule benefits. 

1. Calculation of Baseline Health Risk 

As part of the quantitative analysis to 

determine the GWR benefits, EPA 

estimated the ‘‘baseline risk’’ (preGWR)—the number of people becoming 

ill and/or dying each year from Type A 

(represented by rotavirus) and Type B 

(represented by enterovirus or 

echovirus) viral infection due to 

consumption of ground water from 

public water supplies (see Table VII–4). 

The risk analysis uses these two viruses 

as surrogates for waterborne viruses. 

The annual estimated number of viral 

illnesses from exposure to Type A and 

Type B viruses ranges from about 33,000 

to 476,000 cases, with a mean of 

approximately 185,000 cases. EPA 

estimates that about 0.3 to 11 deaths per 

year (mean of three deaths) prior to this 

rule as a result of exposure to viruses. 

These numbers are the ‘‘baseline’’ used 

to estimate the health risk reduction and 

their associated monetized value of risk 

reduction due to implementation of this 

rule. As discussed earlier, bacterial 

illnesses and deaths are not considered 

in the baseline, and only endemic, acute 

viral illnesses from the two surrogate 

viruses are considered. 

TABLE VII–4.—ESTIMATES OF BASELINE VIRAL ILLNESSES AND DEATHS DUE TO CONTAMINATION OF GROUND WATER

SYSTEMS

Illnesses per year Deaths per year 

Virus type Mean 5th–95th 

Percentiles Mean 5th–95th Percentiles 

Type A (rotavirus) .................................................................................. 175,168 32,652–435,381 1.2 0.2–2.9 

Type B (enterovirus or echovirus) ......................................................... 10,018 501–40,718 2.0 0.0–8.1 

Total ................................................................................................ 185,186 33,153–476,099 3.2 0.3–11.0 

2. Calculation of Avoided Illnesses and 

Deaths 

The GWR requirements are projected 

to result in a significant reduction in 

exposure to fecal contamination. EPA 

used a risk assessment model to 

estimate the avoided viral illnesses and 

deaths. The risk assessment model 

estimates reductions in baseline 

incidence considering the effects of the 

sanitary survey and triggered source 

water monitoring. Assessment source 

water monitoring is optional and is not 

included in this analysis (see Section 

VII J.10). Table VII–5a shows the 

calculated viral illnesses and deaths 

avoided due to the GWR. The rule is 

expected to avoid (mean value) 

approximately 42,000 viral illnesses and 

one viral death annually (averaged over 

25 years). Details of the assumptions 

and methodology used in the model are 

described in the GWR EA (USEPA, 

2006d). Table VII–5b shows the 


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calculated viral illnesses and deaths 

avoided due to the GWR by system type. 

More detailed information about the 

GWR benefits assessment and all data 

and analyses used in predicting those 

benefits can be found in the GWR EA 

(USEPA, 2006d). 

TABLE VII–5A.—SUMMARY OF ANNUAL VIRAL ILLNESSES AND DEATHS AVOIDED FOR THE GWR 

Illnesses avoided per year Deaths avoided per year 

Virus type Mean 5th–95th 

Percentiles Mean 5th–95th Percentiles 

Type A (rotavirus) .................................................................................. 39,442 10,093–79,925 0.3 0.1–0.5 

Type B (enterovirus or echovirus) ......................................................... 2,426 181–8,114 0.5 0.0–1.6 

Total ................................................................................................ 41,868 10,274–88,039 0.7 0.1–2.1 

Note: Details may not add to totals due to independent rounding and independent statistical analyses. 

Source: GWR Illness Model. 

TABLE VII–5B.—SUMMARY OF ANNUAL AVOIDED VIRAL ILLNESSES AND DEATHS BY SYSTEM TYPE

Illnesses avoided per year Deaths avoided per year 

System type Mean 5th–95th 

Percentiles Mean 5th–95th Percentiles 

CWSs ..................................................................................................... 32,031 8,704–68,994 0.6 0.1–1.8 

NTNCWSs ............................................................................................. 2,094 533–4,308 0.03 0.0–0.1 

TNCWSs ................................................................................................ 7,743 1,037–14,738 0.1 0.01–0.2 

Total ................................................................................................ 41,868 10,274–88,039 0.7 0.1–2.1 

Note: Estimates are derived from independent model runs, and, therefore, detail may not add to total. Values are endemic, acute viral illnesses and deaths avoided following full implementation of the GWR and only accounts for rotavirus and echovirus. 

Source: Derived from GWR model output. 

3. Derivation of Quantified Benefits 

EPA quantified the benefits for the 

GWR based on reductions in the risk of 

endemic, acute viral illness as explained 

in Section VII.B.2. Next, EPA monetized 

benefits for nonfatal viral illnesses and 

mortalities avoided by the GWR. Table 

VII–3 shows the estimated monetized 

value for viral illnesses and deaths 

avoided by the GWR. 

Benefits for nonfatal cases of endemic, 

acute viral illness were calculated using 

a cost-of-illness (COI) approach. 

Traditional COI valuations focus on 

medical costs and lost work time and 

leave out significant categories of 

benefits, specifically, the reduced utility 

from being sick (i.e., lost personal or 

nonwork time, including activities such 

as child care, homemaking, community 

service, time spent with family, and 

recreation), although some COI studies 

also include an estimate for unpaid 

labor (household production) valued at 

an estimated wage rate designed to 

reflect the market value of such labor 

(e.g., median wage for household 

domestic labor). 

Ideally, a comprehensive willingness 

to pay (WTP) estimate would be used 

that includes all categories of loss in a 

single number. However, a review of the 

literature indicated that the available 

studies were not suitable for valuing 

acute viral illness; hence, estimates from 

this literature are inappropriate for use 

in this analysis. Instead, EPA presents 

two COI estimates: a traditional 

approach that only includes valuation 

for medical costs and lost work time 

(including some portion of unpaid 

household production) and an enhanced 

approach that also factors in valuations 

for lost unpaid work time for employed 

people, reduced utility (or sense of wellbeing) associated with decreased 

enjoyment of time spent in non-work 

activities, and lost productivity at work 

on days when workers are ill but go to 

work anyway. The first two categories of 

loss are estimated by multiplying the 

average wage rate by the number of nonwork waking hours. The third category 

is estimated by multiplying all waking 

hours (work and non-work) by 30 

percent of the wage rate for days when 

subjects are ill but report for work 

anyway. 

The computation of COI involves two 

broad categories of costs—direct and 

indirect medical costs. All costs are 

updated to a common year (2003) used 

as the starting point for projecting 

benefits into future time periods. For 

Type A viruses, each cost component 

has a separate estimate made based on 

age and the health state of the 

individual (healthy or 

immunocompromised). For Type B 

viruses, cost components have separate 

estimates based both on age and on the 

type of care required (i.e., no medical 

care, outpatient care, or inpatient care). 

Chapter 5 of the GWR EA (USEPA, 

2006d) has a detailed breakout of both 

Type A and Type B COI estimates. 

For both the Enhanced COI and 

Traditional COI, the direct cost for a 

case of Type A or Type B viral illness 

is derived by summing the costs of 

outpatient and inpatient care (in 2003$). 

Outpatient care consists of an initial 

physician visit ($114.55) and the 

product of the cost of each follow-up 

visit ($66.18) and the number of followup visits. Multiplying this sum by the 

percentage of patients that utilize 

outpatient services yields the weighted 

unit cost of outpatient care. The cost of 

inpatient care consists of the costs of the 

initial doctor visit in the hospital 

($152.87), any follow-up visits ($52.25), 

and the hospital charges (calculated on 

a per day basis, with costs ranging from 

$1,007 per day for Type A illnesses to 

$4,870 per day for a severe case of Type 

B illness). As with outpatient costs, 

multiplying the sum of doctor visits and 

hospital charges by the percentage of 

patients who require inpatient care 

yields the weighted unit cost of 

inpatient care. 

The sum of the weighted unit costs of 

outpatient and inpatient care equals the 

weighted direct costs. The weighted 

direct medical costs per case of Type A 

viral illness ranges from an average cost 

of $0 (for healthy patients, five years old 


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and up requiring no medical care) to 

$4,486 (for immunocompromised 

patients younger than five years old). 

The weighted direct medical costs per 

case of Type B viral illness range from 

an average of $0 (for patients requiring 

no medical care) to $23,431 (for patients 

less than one month old requiring 

inpatient care). 

Total indirect cost is the sum of the 

value of patient days lost, the value of 

productivity lost, and the value of care 

giver days lost. For the Enhanced COI, 

the total indirect cost associated with a 

case of Type A viral illness ranges from 

an average of $103 (for healthy patients 

16 years old and older) to $2,136 (for 

immunocompromised patients under 

two years of age). Indirect costs 

associated with cases of Type B viral 

illness range from $336 (for patients 16 

years old and older requiring no 

medical care) to $2,990 (for patients 

under 16 years of age requiring inpatient 

care). 

For the Traditional COI, the total 

indirect cost associated with a case of 

Type A viral illness ranges from an 

average of $39 (for healthy patients 16 

years old and older) to $426 (for 

immunocompromised patients two 

years of age and younger). Indirect costs 

associated with cases of Type B viral 

illness range from $126 (for patients 16 

years old and older requiring no 

medical care) to $596 (for patients 

requiring inpatient care). 

The valuation of children’s time 

presents unique problems. The best 

approach when valuing children’s 

health effects is the use of child-specific 

valuations of these effects. For direct 

costs, EPA has used such valuations. 

Indirect costs, however, prove more 

challenging. As noted in the Children’s 

Health Valuation Handbook (USEPA, 

2003c), ‘‘[children’s] time lost to 

sickness also has value, although no 

direct measure exists for this loss.’’ In 

this instance, the Handbook states that, 

‘‘as a second-best option, * * * transfer 

benefit values estimated for adults to 

children.’’ The Enhanced COI uses this 

guideline, in conjuncture with 

Executive Order 13045 (‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’), and assumes a 

day lost due to illness (lost patient day) 

for the duration of illness for patients 

younger than 16 years to be valued at 

$199.36 (based on the median post-tax 

wage). In contrast, the Traditional COI 

assigns no lost patient day value for 

children under 16 years of age because 

this approach assigns a monetary value 

only to lost wages (or lost unpaid work 

time for adults not in the paid labor 

market). Both the Traditional and 

Enhanced COI approaches assume that 

a caregiver stays home with these 

children, introducing additional lost 

caregiver days for each lost patient day. 

The number of days lost entirely to 

illness, either by the adult patient or 

caregiver, is multiplied by $227.79 (for 

the Enhanced COI) or $85.12 (for the 

Traditional COI), the average value of a 

lost day. 

In addition, for days when an 

individual is well enough to work but 

still experiencing symptoms, such as 

diarrhea, the Enhanced COI estimate 

also includes a 30 percent loss of work 

and leisure productivity (i.e. 30 percent 

of the wage rate times 16 hours) based 

on a study of giardiasis illness 

(Harrington et al., 1985). In the 

Traditional COI analysis, productivity 

losses are not included for either work 

or nonwork time. No productivity losses 

are assigned to children under 16 years 

of age under either the Traditional or 

Enhanced COI approaches. 

The Agency believes that losses in 

productivity and lost leisure time are 

unquestionably present and that these 

categories have positive value; 

consequently, the Traditional COI 

estimate understates the true value of 

these loss categories. However, using 

the wage rate to estimate the loss of 

utility during non-work hours may 

understate or overstate the value of this 

loss, depending on severity of illness 

and other factors. Similarly, using 30 

percent of the wage rate to estimate the 

value of lost productivity in work and 

leisure when a person is still 

experiencing symptoms but is well 

enough to go to work may understate or 

overstate benefits. EPA notes that these 

estimates should not be regarded as 

upper and lower bounds. In particular, 

the Enhanced COI estimate may not be 

an upper bound, because it may not 

fully incorporate the value of pain and 

suffering. 

As with the avoided mortality 

valuation, the real wages used in the 

COI estimates were increased by a real 

income growth factor that varies by 

year, but is the equivalent of about 1.8 

percent per year over the 25-year period. 

This approach of adjusting for real 

income growth was recommended by 

the SAB (USEPA, 2000d) because the 

median real wage is expected to grow 

each year (by approximately 1.8 

percent). Correspondingly, the real 

income growth factor of the COI 

estimates increases by the equivalent of 

1.8 percent per year (except for medical 

costs, which are not directly tied to 

wages). 

Reductions in mortalities were 

monetized using EPA’s standard 

methodology for monetizing mortality 

risk reduction. This methodology is 

based on a distribution of value of 

statistical life (VSL) estimates from 26 

labor market and stated preference 

studies. For this analysis, EPA 

incorporated the Weibell Distribution 

into the benefit model Monte-Carlo 

simulation and updated the VSLs to 

2003 dollars. The updated mean VSL in 

2003 dollars is $7.4 million. A real 

income growth factor was applied to 

these estimates of approximately 1.8 

percent per year for the 25-year time 

span following implementation. Income 

elasticity for VSL was estimated as a 

triangular distribution that ranged from 

0.08 to 1.00, with a mode of 0.40. VSL 

values for the 25-year time span are 

shown in the GWR EA in Exhibit B.6 

(USEPA, 2006d). A more detailed 

discussion of these studies and the VSL 

estimate can be found in EPA’s 

Guidelines for Preparing Economic 

Analyses (USEPA, 2000c). 

4. Nonquantifiable Benefits 

There are substantial benefits 

attributable to the GWR that are not 

quantified as part of this rulemaking 

because of data limitations. The GWR 

quantifies only the endemic, acute 

illnesses and deaths due to rotavirus 

and enterovirus. By reducing bacterial 

and other viral illnesses and deaths, this 

rule provides significant health benefits 

beyond the monetized benefit estimates. 

Chronic illnesses (such as diabetes, 

dilated cardiomyopathy, and reduced 

kidney function), kidney failure, and 

hypertension (e.g., Garg et al., 2005) 

resulting from waterborne viral and 

bacterial pathogens are also not 

quantified but provide additional 

benefits, although such cases are likely 

to be relatively rare. Additional health 

benefits will accrue from preventing 

outbreaks, reducing periods with 

insufficient disinfection, and 

minimizing contaminant infiltration 

into distribution systems. 

This rule will also result in nonhealth benefits such as avoided outbreak 

response costs, increased information 

gained through source water monitoring 

that will in turn provide benefits to the 

systems and their customers, and 

reduced uncertainty regarding drinking 

water safety, which may lead to reduced 

costs for averting behaviors. 

In addition, the optional assessment 

source water monitoring provision will 

provide additional benefits similar to 

those already described (i.e. reduction 

in viral and bacterial illness). However, 

EPA was not able to quantify either the 

benefits or costs of this program because 

EPA does not know the extent to which 

States will use the option or the manner 

in which they will implement it. 

Because this provision could potentially 


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increase both benefits and cost, a more 

complete discussion can be found in the 

Section VII.J.10 of this preamble. 

EPA believes that, collectively, these 

benefits, both health and non-health, 

significantly exceed those which EPA 

was able to quantify and are a major 

basis for supporting the preferred 

regulatory alternative. A qualitative 

discussion of these nonquantified 

benefits is included in Section 5.4 of the 

GWR EA (USEPA, 2006d); a summary of 

this discussion appears below. 

a. Decreased incidence of illness from 

bacteria. In addition to reducing the 

number of illnesses and deaths due to 

drinking water related to some viral 

illnesses, the ground water source 

monitoring and corrective actions taken 

under the GWR will also reduce the 

number of illness and deaths due to 

bacteria in drinking water. EPA was 

unable to quantify the benefits from 

preventing bacterial illness; however, 

EPA provides a rough estimate of 

illnesses and deaths prevented through: 

• Estimating potential bacterial 

illnesses avoided; 

• Estimating a mortality rate for 

waterborne bacterial illness; and 

• Estimating potential annual deaths 

avoided by the GWR. 

The first of the analytical steps 

applies the ratio of waterborne disease 

outbreak incidence rates between 

bacteria and viruses to the quantified 

viral cases avoided to estimate bacterial 

cases avoided. The second analytical 

step derives mortality rates for types of 

bacterial illness associated with 

waterborne disease outbreaks. The third 

analytical step combines the first two 

steps to devise a rough estimate of 

annual bacterial deaths avoided. EPA 

estimates that total quantified benefits 

could increase by a factor of five if EPA 

was able to account for additional 

deaths and hospitalizations caused by 

bacterial illness being avoided (i.e., not 

even considering the value of reduced 

non-fatal non-hospitalization caused 

bacterial illnesses). More information on 

this calculation can be found in Chapter 

5 of the GWR EA (USEPA, 2006d). 

b. Decreased illness from other 

viruses. Quantified benefits accrue from 

endemic, acute illnesses associated with 

rotavirus (a Type A virus) and 

enterovirus or echovirus (a Type B 

virus) as discussed previously. 

Nonquantified health benefits 

attributable to viruses include decreased 

incidence of gastroenteritis caused by 

other Type A viruses such as norovirus, 

astrovirus, and adenovirus; decreased 

incidence of other acute disease 

endpoints (e.g., hepatitis and 

conjunctivitis) caused by types of 

viruses not modeled in the quantified 

benefits analysis; and decreased 

incidence of chronic illness associated 

with Type B virus (e.g., diabetes and 

dilated cardiomyopathy). 

The health effects of norovirus (the 

most common Type A virus) illness 

include acute onset of nausea, vomiting, 

abdominal cramps, and diarrhea 

(USEPA, 2006d). EPA believes that 

nausea and vomiting associated with 

norovirus, typically absent in rotavirus 

illness, suggest that the norovirus 

disease burden (e.g., number of 

productive days lost) associated with 

PWS wells is important, especially for 

adults with whom norovirus disease is 

quite prevalent. EPA believes that if 

norovirus were included in the 

quantified benefits, there would be 

significantly greater monetized benefits 

for Type A viruses, because monetized 

rotavirus disease burden (the only Type 

A virus modeled) provides only a small 

benefit for adults since most adults are 

immune to rotavirus. 

Other acute and chronic viral 

illnesses can be acquired from 

consuming ground water contaminated 

with other Type A or Type B viruses, 

but the Agency was unable to quantify 

or monetize them. These include severe, 

acute illnesses such as hepatitis A; 

milder, acute illnesses such as 

conjunctivitis; and severe chronic 

illnesses such as diabetes and dilated 

cardiomyopathy. Most chronic illnesses 

are costly to treat. Lifetime costs 

associated with a new case of diabetes, 

for example, assuming an average 

illness duration of 30 years, are 

estimated at $227,032 using a three 

percent discount rate and $143,733 

using a seven percent discount rate 

(year 2003 dollars). For dilated 

cardiomyopathy, the lifetime (21 year 

average) cost is $61,117 (seven percent 

discount rate, year 2003 dollars). These 

illnesses are discussed in further detail 

in the GWR EA (USEPA, 2006d). 

c. Other nonquantifiable benefits. 

Other nonquantified health benefits 

include decreased incidence of 

waterborne disease outbreaks and 

epidemic illness and decreased illness 

through minimizing treatment failures 

or fewer episodes with inadequate 

treatment. The nonquantified nonhealth benefits include improved 

perception of ground water quality and 

perception about reduced risk 

associated with PWS wells, potential 

reduced use of bottle water and pointof-use devices, reduced time spent on 

averting behavior such as obtaining 

alternative water supplies, and avoided 

costs associated with outbreak response. 

Pathogenic protozoa can occur in 

PWS wells, typically when such 

systems are misclassified and are not 

recognized as GWUDI systems. In PWSs 

with elevated ground water 

temperatures, Naegleria fowleri can 

colonize the distribution system, well, 

well gravel-pack, or aquifer. N. fowleri 

is fatal when inhaled (and treatment is 

not timely) and two five-year old boys 

died in the same week from exposure 

via a GWS in Arizona (Marciano-Cabral 

et al., 2003). N. fowleri is inactivated by 

disinfection, so corrective action 

implemented as the result of this rule 

that includes disinfection may prevent 

death from this organism. However, the 

benefits from avoiding these deaths are 

nonquantified. Cryptosporidiosis and 

giardiasis outbreaks in sensitive PWS 

wells have also occurred (see Section 

III.C.2). Sanitary surveys and additional 

monitoring under the GWR combined 

with existing source water assessments 

and Long Term 2 Surface Water 

Treatment Rule (LT2ESWTR) (71 FR 

654, January 5, 2006) (USEPA, 2006i) 

implementation can, in combination, 

minimize the likelihood of 

misclassification of PWS wells (as nonGWUDI) and reduce the likelihood of 

outbreaks associated with such 

misclassification. This rule only 

qualitatively considers the benefits of 

identifying misclassified PWS wells. 

Several nonhealth benefits from this 

rule were also recognized by EPA but 

were not monetized. The nonhealth 

benefits of this rule include avoided 

outbreak response costs (such as the 

costs of providing public health 

warnings, boiling drinking water and 

providing alternative supplies, 

remediation and repair, and testing and 

laboratory costs). Expenses associated 

with outbreaks can be 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 $43 million in 

Canadian dollars (approximately $32 

million in U.S. dollars) (Livernois, 

2002). The author believed that this was 

a conservative estimate. 

5. How Have the Benefits Changed 

Since the Proposal? 

The estimated annual quantified 

benefits for the GWR have changed from 

$205 million (year 2000 dollars, both at 

3 percent and 7 percent discount rates) 

to $19.7 million (year 2003 dollars, at 3 

percent) using enhanced cost-of-illness 

estimates and $10.0 million (year 2003 

dollars, at 3 percent) using traditional 

cost-of-illness estimates (these are $16.8 

and $8.6 using a 7 percent discount 

rate). The proposal only included the 

enhanced cost-of-illness measure. The 

change in quantified benefits is due to 


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changes in both the economic analysis 

estimates (e.g., interpretation of 

occurrence and other data) and GWR 

provisions. However, changes in the 

economic analysis estimates are the 

dominant factor in explaining the large 

change in benefits from the proposal. 

Estimates in the GWR EA that were 

changed and that most influenced the 

change in the quantified benefit 

estimate include: 

• Frequency and duration of viral 

occurrence in wells; 

• Percentage of wells associated with 

high versus low viral concentrations; 

• Efficiency by which virally 

contaminated wells are identified and 

prescribed corrective action; 

• Severity of symptoms associated 

with predicted illnesses 

• Monetized value of illnesses 

avoided; and 

• Using net present values and then 

annualizing benefits. 

EPA believes that the changes made 

in the GWR EA since proposal 

substantially improve upon the 

scientific basis for the quantified 

benefits, a major issue raised by public 

comments (see Section VII.J of this 

preamble for further discussion of 

public comments). Chapter 5 of the 

GWR EA describes the basis for the 

analysis (USEPA, 2006d). 

Changes in the rule provisions also 

impacted the final benefit estimate but 

these changes are not as significant as 

the changes made in the economic 

analysis. In addition, the benefits (as 

well as costs) for the optional 

assessment source water monitoring and 

additional fecal indicator sampling 

following triggered source water 

monitoring are not included in the final 

rule analysis. These potential impacts 

are discussed in Section VII.J.10. 

Another major change in the GWR EA 

since proposal is a more thorough 

analysis of the nonquantified benefits. 

EPA’s analysis of the potential benefits 

from avoided bacterial illness suggests 

that the nonquantified benefits may 

exceed the quantified benefits by a 

factor of five (see Chapter 5.4 of the 

GWR EA for a full description of 

nonquantified benefits, USEPA, 2006d). 

D. What Are the Costs of the GWR? 

1. Summary of Quantified Costs 

In estimating the costs of this rule, the 

Agency considered impacts on public 

water systems and on States. Table VII–

6 summarizes these costs in terms of 

annualized present value: $61.8 million 

(using a three percent discount rate) and 

$62.3 million (using a seven percent 

discount rate). Most costs occur early in 

the implementation schedule, therefore 

the values do not differ much using 

different discount rates. 

To calculate the national costs of 

compliance, the Agency used a MonteCarlo simulation model specifically 

developed for the GWR. The main 

advantage of this modeling approach is 

that in addition to providing average 

compliance costs, it also estimates the 

range of costs within each PWS size and 

category. It also allows the Agency to 

capture the variability and uncertainty 

in areas such as PWS configuration, 

current treatment in-place, source water 

quality, existing State requirements, 

unit costs of treatment technologies, and 

compliance forecasts. The 90 percent 

confidence bounds shown in Table VII–

6 reflect the quantified uncertainties. 

Table VII–6 shows the estimated 

annualized present value costs of this 

rule. Drinking water utilities will incur 

approximately 81 percent of the rule’s 

costs. States will incur the remaining 

costs of the rule. In addition to the mean 

estimates of costs, the Agency 

calculated 90 percent confidence 

intervals by considering, for example, 

the uncertainty in the mean unit 

technology costs. Table VII–7 shows the 

undiscounted capital costs and all onetime costs for both water systems and 

States. The derivation of these cost 

numbers can be found in Chapter 6 of 

the GWR EA (USEPA, 2006d). The 

itemized costs of this rule are presented 

below for systems and States, 

respectively. 


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2. Derivation of Quantified Costs 

a. Summary of Baseline Estimate. To 

quantify the effects of the rule, it is 

necessary to have a baseline against 

which to compare the set of regulatory 

requirements. The baseline is a 

characterization of the industry and its 

operations under the conditions 

expected to exist before systems make 

changes to meet requirements of this 

rule. As discussed in Section IV of this 

preamble, the regulatory requirements 

can be system, entry point, or well level 

requirements. These requirements, to a 

large extent, depend upon the levels of 

existing protection from microbial risks, 

e.g., disinfection levels. Table VII–8a 

presents the major baseline information 

for this rule. The number of entry points 

or wells varies by system size, with 

larger systems generally having more 

entry points. Chapter 4 of the GWR EA 

for this rule provides a detailed 

description of the GWR baselines 

(USEPA, 2006d). 

b. Rule Implications. To calculate the 

cost impact of each rule alternative on 

GWSs, the Agency estimated how many 

systems and their associated entry 

points to distribution systems and wells 

would be affected by the various rule 

requirements based on national fecal 

indicator occurrence information, as 

discussed in Section VII.B.1. The 

Agency developed compliance forecast 

estimates that predict the number of 

systems, entry points, or wells that 

incur costs to comply with each 

regulatory requirement. Table VII–8b 

shows these numbers broken down by 

system type and size category. Chapter 

6 of the GWR EA for this rule provides 

further description of the estimates of 

rule implications (USEPA, 2006d). 

c. System Costs. This rule is estimated 

to cost public GWSs $50.0 million 

annually using a three percent discount 

rate ($50.6 million annually using a 

seven percent discount rate). The cost 

impacts to systems complying with the 

GWR stem from implementing the rule, 

assisting with sanitary surveys, 

performing source water and 

compliance monitoring, and performing 

corrective actions. Not every system is 

expected to incur all of these costs 

because the compliance activities for 

systems depend on the results from 

sanitary surveys, analysis of total 

coliform samples under the TCR, and 

source water monitoring. 

The estimated costs for each of the 

rule requirements are summarized in 

Table VII–8c with a mean, upper bound, 

and lower bound. The mean and 

confidence bounds are equal for some of 

the costs because EPA derived these 

costs from point estimates. The total 

annualized costs to systems are 

presented in Table VII–9 by system size 

and type. The detailed calculation of 

these cost numbers are presented in 

Chapter 6 of the GWR EA (USEPA, 

2006d). 

To analyze the different rule 

components, the Agency had to 

distinguish between correction of 

significant deficiencies identified 

during sanitary surveys and the 

corrective actions that result from fecal 

indicator-positive ground water source 

samples. It was not possible to estimate 

costs for all conceivable corrective 

actions that a system may potentially 

encounter on a national level due to 

system-to-system variability. As a result, 

the Agency estimated costs for 

representative corrective actions that 

may be implemented to address 

significant deficiencies identified by 

sanitary surveys and source water fecal 

contamination, respectively. Table VII–

10 shows the representative corrective 

actions. 

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BILLING CODE 6560–50–C 

Because the exact timing and 

distribution of problems among systems 

that may be identified by the sanitary 

surveys is not known, an average annual 

GWS cost of correcting significant 

defects is calculated by summing the 

cost of correcting all significant 

deficiencies over the 25-year period of 

analysis and apportioning them evenly 

over the period during which they are 

performed. 

For entry points with fecal indicatorpositive ground water source samples 

(from triggered source water 

monitoring), systems must perform 

corrective action to comply with the 

GWR. For cost estimation purposes, the 

model assumes that for every source 

water positive sample, at least one 

additional sample will also be positive 

(i.e., corrective action ultimately follows 

every source water positive) (see 

Chapter 6 of GWR EA (USEPA, 2006d) 

for a complete discussion of this 

assumption). For non-disinfecting 

systems, the model assigns one 

representative nontreatment corrective 

action or one disinfection/treatment 

corrective action (Table VII–10). The 

cost model assigns nondisinfecting 

entry points that need to take corrective 

actions to the treatment category using 

the current proportion of all entry 

points providing treatment for different 

size categories. The current proportion 

is a range of the estimated existing 

percentages of treatment entry points 

among the entry points with less than 4- 

log disinfection and without 

disinfection. 

For nontreatment corrective actions to 

comply with the GWR, the cost model 

assigns equal proportions of entry 

points to high and low cost scenarios 

and then assigns a representative 

corrective action according to the 

corresponding percentages in that 

scenario. For entry points predicted to 

use treatment corrective actions, the 

cost model assigns one of the possible 

treatment technologies based on the 

relative percentage of CWSs currently 

engaged in those treatment practices. 

Finally, for entry points that require 

corrective actions because of source 

water fecal contamination (from 


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triggered source water monitoring) and 

already disinfect, but the disinfection 

does not achieve at least a 4-log 

treatment of viruses before or at the first 

customer, the compliance forecast 

assigns a corrective action that either 

increases the dose for hypochlorination 

or chlorine gas or adds storage. More 

information regarding the compliance 

forecasts of corrective actions can be 

found in Chapter 6 of the GWR EA 

(USEPA, 2006d). 

TABLE VII–10.—REPRESENTATIVE CORRECTIVE ACTIONS

Representative corrective actions Note 

For Significant Deficiencies at Source Identified 

by Sanitary Survey.

Replace a Sanitary Well Seal .......................... Low cost option. 

Rehabilitate an Existing Well ........................... High cost option. 

For Entry Points with a Fecal Indicator-Positive 

Ground Water Source Sample.

Non-Treatment Options ...................................

Rehabilitate an Existing Well 

Drill a New Well 

Purchase Water 

Eliminate Source of Contamination 

Interim disinfection is included for costing. 

Treatment Options ...........................................

Disinfection Alternatives or Nanofiltration 

Chlorine gas and hypochlorite will be most 

likely choices for large and small systems, 

respectively. 

In addition to the treatment technique 

costs, EPA estimated the cost for 

systems to conduct monitoring. It is 

important to remember that triggered 

source water monitoring applies only to 

systems that do not achieve 4-log 

treatment of viruses. Compliance 

monitoring applies to systems that 

currently provide 4-log treatment of 

viruses, or those that install treatment as 

a result of this rule. Assessment source 

water monitoring is optional and is not 

included in either the cost or benefit 

estimates (see Section VII.J.10). 

The triggered source water monitoring 

costs are calculated based on the cost of 

the test and the operator’s time to 

collect and transport the sample. GWSs 

have to collect a ground water source 

sample and analyze it for the selected 

indicator organism when the system 

experiences a total coliform-positive 

under the TCR. If the indicator sample 

is positive, the system either takes five 

additional samples or does corrective 

action immediately. If any of the 

additional samples is positive, the 

system must implement a corrective 

action. Specific issues regarding the 

monitoring cost estimate are described 

in Section VII.C.3 of this preamble. The 

GWR EA has a more detailed discussion 

of the monitoring cost analysis (USEPA, 

2006d). 

The cost of compliance monitoring 

varies with system size. Compliance 

monitoring is required for any system 

that currently provides 4-log treatment 

of viruses or installs treatment as a 

result of complying with this rule’s 

treatment technique requirements. EPA 

assumes that systems with treatment 

technology in place prior to the GWR 

promulgation incur minimal additional 

capital or operation and maintenance 

(O&M) costs for compliance monitoring 

because GWSs should already have a 

monitoring program in place and has 

not included them in the cost analysis. 

However, the Agency does include costs 

for systems to notify the State that they 

achieve at least 4-log treatment of 

viruses or to notify the State in case of 

system failure. 

For those systems adding a 

technology that provides 4-log treatment 

of viruses as a corrective action for 

source water fecal contamination, EPA 

assumes that monitoring equipment will 

also be installed to perform compliance 

monitoring. The cost varies by system 

size because the monitoring 

requirements vary by size category. A 

more detailed explanation of 

compliance monitoring schemes is 

discussed in Section IV.C. 

d. State costs. As indicated in Table 

VII–6, EPA estimates that States will 

incur less than $11.8 million in 

annualized costs due to the additional 

sanitary survey requirements in this rule 

(including increased frequency of 

sanitary surveys), tracking monitoring 

information, reviewing action plans, 

data management, and other activities. 

Along with system costs, State costs are 

also summarized in Table VII–8c. 

States will incur administrative costs 

while implementing the GWR. These 

implementation costs are not directly 

required by specific provisions of GWR 

alternatives, but are necessary for States 

to ensure the provisions of the GWR are 

properly carried out. States will also be 

required to spend time responding to 

PWSs whose ground water sources are 

found to be fecally contaminated, or 

have significant deficiencies. These 

costs include time to review plans and 

specifications, prepare violation letters, 

and enter data. States will need to 

allocate time for their staff to establish 

and then maintain the programs 

necessary to comply with the GWR, 

including developing and adopting 

State regulations, modifying data 

management systems to track newly 

required system reports to the States, 

and providing ongoing technical 

assistance to GWSs. For those GWR 

requirements that include monitoring 

with a laboratory method not currently 

required by the State, the State must 

devote a portion of its staff time to 

certifying laboratories for the new 

analytical method. Time requirements 

for a variety of State agency activities 

and responses are estimated in Chapter 

6 of the GWR EA (USEPA, 2006d). 

In addition to these one-time costs, 

States will use resources to continue 

activities for the implementation of the 

GWR unrelated to any specific 

provision. States with primacy 

enforcement responsibilities have 

recordkeeping (§ 142.14) and reporting 

(§ 142.15) requirements associated with 

primacy enforcement and must 

coordinate with EPA for review of the 

State primacy program. States must also 

continue to train their personnel and 

PWS staff, maintain laboratory 

certifications, and report system 

compliance information to the Safe 

Drinking Water Information System 

(SDWIS). 

3. Nonquantifiable Costs 

Although EPA has quantified the 

significant costs of the GWR, there are 

some costs that the Agency did not 

quantify. Overall, EPA believes that 

these nonquantified costs are much 

smaller than the nonquantified benefits. 

These nonquantified costs result from 

uncertainties surrounding rule 

assumptions and from modeling 

assumptions. For example, EPA 

estimated that some systems may need 

to acquire land if they need to build a 

treatment facility or drill a new well. 

This was not considered for most 

systems because EPA expects that the 

majority of the technologies that 


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systems will use to comply with this 

rule will fit within the existing plant 

footprint. In addition, if the cost of land 

is prohibitive, a system may choose 

another lower cost alternative such as 

connecting to another source. EPA has 

also not quantified costs for systems 

already using disinfection to conduct 

compliance monitoring because EPA 

believes that such systems are already 

incurring these costs. 

In addition, the optional assessment 

source water monitoring provision was 

not included in the quantitative cost 

analysis. EPA was not able to quantify 

either the benefits or costs of this 

program. Because this provision could 

potentially increase both benefits and 

cost, a more complete discussion can be 

found in Section VII.J of this preamble. 

Due to lack of information, EPA was 

unable to quantify the costs (as well as 

benefits) from the correction of sanitary 

survey deficiencies in distribution 

systems and treatment plants. This is 

discussed in Section VII.J of this 

preamble. 

Also, the Agency did not include the 

costs for taking five additional samples 

following a positive source water 

sample. However, EPA overestimated 

the cost of triggered source water 

monitoring because it assumed all 

systems would take an additional 

sample beyond the current TCR 

requirements. However, many small 

systems (and most GWSs are small) will 

be able to use one of their TCR repeat 

samples to also comply with the GWR. 

Overall, the impact of not including the 

five additional sample cost 

(approximately $200,000 per year) is 

much smaller compared to the 

overestimate of a few million dollars 

associated with the initial fecal 

indicator sampling cost already 

conducted for TCR monitoring. 

4. How Have the Costs Changed Since 

the Proposal? 

The estimated annual quantified costs 

for the GWR have changed from $183 

million and $199 million (year 2000 

dollars at proposal, using three and 

seven percent discount rates, 

respectively) to $61.8 million and $62.3 

million (year 2003 dollars, using three 

and seven percent discount rates, 

respectively). The change in quantified 

costs is due to changes in both the 

economic analysis estimates (e.g., 

interpretation of occurrence and other 

data) and GWR provisions. However, 

changes in the economic analysis 

estimates are the dominant factor in 

explaining the large change in costs 

from the proposal. The major changes in 

economic analysis estimates include the 

following: 

• The number of significant 

deficiencies and corrective actions in 

wells from sanitary survey provisions; 

• State costs for the incremental 

changes to existing sanitary survey 

programs; 

• The total coliform-positive samples 

under the TCR and the number of 

triggered source water monitoring 

samples required under the GWR; 

• The frequency and duration of fecal 

indicator occurrence in wells; 

• The efficiency by which fecally 

contaminated wells are identified and 

therefore performing a corrective action; 

• Compliance forecasts include a 

higher percentage of non-treatment 

corrective actions; and 

• Using net present values and then 

annualizing costs. 

EPA believes that the changes made 

in the GWR EA since proposal 

substantially improve the basis for 

quantifying the GWR costs with more 

available data, a major issue raised by 

public comments (see Section VII.L of 

this preamble for further discussion of 

major public comments). 

Changes in the rule provisions also 

impacted the final cost estimate but 

these changes are not as significant as 

the changes made in the economic 

analysis. In addition, the costs (as well 

as benefits) for optional assessment 

source water monitoring and additional 

fecal indicator sampling following 

triggered source water monitoring are 

not included in the final rule analysis. 

These potential impacts are discussed in 

Section VII.J. 

Another major change in the 

Economic Analysis since the proposed 

GWR is a more thorough analysis of the 

nonquantified costs. Chapter 6 of the 

GWR EA describes the basis for the 

analysis (USEPA, 2006d). Rule changes 

can be found in Section VII.A of this 

preamble. 

E. What Is the Potential Impact of the 

GWR on Households? 

This analysis considers the potential 

increase in a household’s water bill if a 

CWS passed the entire cost increase 

resulting from this rule on to their 

customers. This analysis is a tool to 

gauge potential impacts and should not 

be construed as a precise estimate of 

potential changes to household water 

bills. 

The household cost analysis only 

considers the impact on CWSs. State 

costs and costs to TNCWSs and 

NTNCWSs are not included in this 

analysis since their costs are not passed 

through directly to households. Table 

VII–11 presents the mean expected 

increases in annual household costs for 

all CWSs, including those systems that 

do not have to take corrective action for 

significant deficiencies or source water 

fecal contamination. Table VII–11 also 

presents the same information for CWSs 

that must take corrective action. 

Household costs tend to decrease as 

system size increases, due mainly to the 

economies of scale for the corrective 

actions. 

As shown in Table VII–11, the mean 

annual household costs for systems 

(including those that do not add 

treatment) range from $0.21 to $16.54 

(systems serving fewer households 

generally have higher average annual 

household costs). Household costs for 

the subset of systems that take 

corrective actions range from $0.45 to 

$52.38. EPA estimates that, as a whole, 

households subject to the GWR face 

minimal increases in their annual costs. 

The lowest increases in household costs 

are for those served by larger systems 

due to significant economies of scale 

and because many already disinfect. 

Approximately 66 percent of the 

households potentially affected by the 

GWR are customers of systems that 

serve at least 10,000 people. Households 

served by small systems that take 

corrective actions will face the greatest 

increases in annual costs. 


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F. What Are the Incremental Costs and 

Benefits of the GWR? 

The GWR regulatory alternatives 

achieve increasing levels of benefits at 

increasing levels of costs. The regulatory 

alternatives for this rule, in rank order 

of increasing costs and benefits are as 

follows: 

• Alternative 1: Sanitary Survey and 

Corrective Action. 

• Alternative 2: Risk-Targeted 

Approach. 

• Alternative 3: Multi-Barrier 

Approach. 

• Alternative 4: Across-the-Board 

Disinfection. 

More information about the 

alternatives is provided in the GWR EA 

(USEPA, 2006d). 

Incremental costs and benefits are 

those that are incurred or realized in 

reducing viral illnesses and deaths from 

one alternative to the next more 

stringent alternative. Estimates of 

incremental costs and benefits are 

useful in considering the economic 

efficiency of different regulatory 

alternatives considered by the Agency. 

Generally, 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 

GWR. Also, as pointed out by the 

Environmental Economics Advisory 

Committee of the Science Advisory 

Board, efficiency is not the only 

appropriate criterion for social 

decisionmaking (USEPA, 2000d). 

For the GWR, presentation of 

incremental quantitative benefit and 

cost comparisons may be 

unrepresentative of the true net benefits 

of the rule because a significant portion 

of the rule’s potential benefits are not 

quantified, particularly bacterial illness 

and deaths (see Section VII.C.4). 

Table VII–12a and Table VII–12b 

present the four regulatory alternatives 

in order of increasing level of reduction 

in waterborne pathogens or increasing 

level of protection from illness. All 

values are annualized mean present 

values expressed in year 2003 dollars. 

The lower and upper bounds of a 90 

percent confidence interval are shown 

below the mean numbers. As shown in 

Tables VII–12a and b, incremental net 

benefits for all alternatives are negative. 

The nonquantified bacterial illness 

benefits would add benefits to all 

alternatives without any increase in 

costs. EPA estimated that the total 

benefits could increase by more than a 

factor of five by accounting for 

additional deaths and hospitalizations 

caused by reduced bacterial illness 

alone. These nonquantified benefits 

have a significant positive impact on the 

incremental benefits and incremental 

net benefits. Both Alternative 3 and 

Alternative 2 could have positive 

incremental net benefits if the bacterial 

benefits are considered. The next 

highest alternative, Alternative 4, has 

such highly negative incremental net 

benefits, and the difference is so 

substantial, that nonquantified benefits 

would be unlikely to compensate. 

However, comparisons between 

Alternative 4 and the other alternatives 

may be between two separate sets of 

benefits, in the sense that they may be 

distributed to somewhat different 

populations. 


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65632 Federal Register / Vol. 71, No. 216 / Wednesday, November 8, 2006 / Rules and Regulations 

TABLE VII

–12a.

—INCREMENTAL

NET

BENEFITS BY

RULE

ALTERNATIVE

—

ENHANCED COI 

[Annualized Present Value Mean, $Millions, 2003$] 

Rule alternatives 

Annual quantified costs 

Annual quantified benefits (enhanced COI) Incremental costs Incremental benefits* Incremental net benefits* 

A B C D E = D

¥C 

Three Percent Discount Rate 

(in dollars) 

Alternative 1: Sanitary Survey and Corrective Action ................................................. 15.3 (11.8–19.2) 3.6 (0.9–9.3) 15.3 3.6 

¥11.7 

Final Rule: Risk-targeted Approach** ......................................................................... 61.8 (45.2–81.4) 19.7 (6.5–45.4) 46.5 16.1 

¥30.4 

Alternative 3: Multi-Barrier Approach .......................................................................... 67.9 (49.4–89.5) 21.3 (7.1–48.7) 6.1 1.6 

¥4.5 

Alternative 4: Across-the-Board Disinfection .............................................................. 686.4 (636.8–735.4) 70.2 (18.3–177.0) 618.5 48.9 

¥569.6 

Seven Percent Discount Rate 

(in dollars) 

Alternative 1: Sanitary Survey and Corrective Action ................................................. 15.3 (11.9–19.0) 2.9 (0.7–7.5) 15.3 2.9 

¥12.4 

Final Rule: Risk-targeted Approach** ......................................................................... 62.3 (46.1–81.6) 16.8 (5.5–38.6) 47.0 13.9 

¥33.1 

Alternative 3: Multi-Barrier Approach .......................................................................... 69.4 (51.0–90.6) 18.2 (6.0–41.6) 7.1 1.4 

¥5.7 

Alternative 4: Across-the-Board Disinfection .............................................................. 665.3 (612.3–717.0) 61.9 (16.1–156.3) 595.9 43.8 

¥552.2 

*Does not include significant nonquantified benefits. See GWR EA Section 5.4 (USEPA, 2006d). **Benefits and costs are also not included for optional assessment source water monitoring. 

TABLE VII

–12b.

—INCREMENTAL

NET

BENEFITS BY

RULE

ALTERNATIVE

—

TRADITIONAL COI 

[Annualized Present Value Mean, $Millions, 2003$] 

Rule alternatives 

Annual quantified costs 

Annual quantified benefits (traditional COI) Incremental costs Incremental benefits* Incremental net benefits* 

A B C D E = D

¥C 

Three Percent Discount Rate 

(in dollars) 

Alternative 1: Sanitary Survey and Corrective Action ................................................. 15.3 (11.8–19.2) 1.9 (0.3–5.5) 15.3 1.9 

¥13.5 

Final Rule: Risk-targeted Approach** ......................................................................... 61.8 (45.2–81.4) 10.0 (2.2–27.0) 46.5 8.2 

¥38.3 

Alternative 3: Multi-Barrier Approach .......................................................................... 67.9 (49.4–89.5) 10.8 (2.5–28.9) 6.1 0.8 

¥5.3 

Alternative 4: Across-the-Board Disinfection .............................................................. 686.4 (636.8–735.4) 35.5 (6.5–102.4) 618.5 24.7 

¥593.8 

Seven Percent Discount Rate 

(in dollars) 

Alternative 1: Sanitary Survey and Corrective Action ................................................. 15.3 (11.9–19.0) 1.5 (0.2–4.5) 15.3 1.5 

¥13.8 

Final Rule: Risk-targeted Approach** ......................................................................... 62.3 (46.1–81.6) 8.6 (1.9–23.0) 47.0 7.1 

¥39.9 

Alternative 3: Multi-Barrier Approch ............................................................................ 69.4 (51.0–90.6) 9.3 (2.1–24.8) 7.1 0.7 

¥6.4 

Alternative 4: Across-the-Board Disinfection .............................................................. 665.3 (612.3–717.0) 31.5 (5.7–90.8) 595.9 22.2 

¥573.7 

*Does not include significant nonquantified benefits. See GWR EA Section 5.4 (USEPA, 2006d). **Benefits and costs are also not included for optional assessment source water monitoring. Notes: The Traditional COI only includes valuation for medical costs and lost work time (including some portion of unpaid household production and caregiver time for sick children). The 

Enhanced COI also factors in valuations for lost personal time (non-worktime) such as child care and homemaking (to the extent not covered by the traditional COI), time with family, and recreation, and lost productivity at work on days when workers are ill but go to work anyway. 

Source: Chapter 8 of the GWR EA (USEPA, 2006d). Ranges in parentheses are the 90 percent confidence bounds. 


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G. Are There Any Benefits From 

Simultaneous Reduction of CoOccurring Contaminants? 

As discussed in Section VII.B.2, the 

GWR is expected to reduce not only 

viral illnesses and deaths (the 

monetized rule benefit) but also 

bacterial illnesses and deaths. This rule 

is also expected to decrease the risk of 

outbreaks that would reduce illnesses 

and deaths and other outbreak-related 

costs. Additional health benefits of this 

rule include the reduction in illnesses 

and deaths associated with reduced 

incidence of upsets or failures among 

disinfecting supplies and reduced 

incidence of distribution system 

contamination among disinfecting and 

non-disinfecting systems. EPA 

anticipates reductions in disease 

incidence in these areas to result from 

the sanitary survey provisions and the 

treatment and monitoring provisions 

pertaining to disinfected supplies. 

If a system chooses to install 

treatment, it may choose a technology 

that would also address other drinking 

water contaminants. If a system had an 

iron or manganese problem, for 

example, the addition of an oxidant and 

filtration could treat this problem as 

well as fecal contamination. Also, some 

membrane technologies installed to 

remove bacteria or viruses can reduce or 

eliminate many other drinking water 

contaminants, including arsenic. EPA 

recognizes that some systems will 

choose these more expensive treatment 

technologies. EPA has included them in 

the decision tree in the cost analysis, 

but no estimate of the additional benefit 

from reducing co-occurring 

contaminants has been made. 

H. Is There Any Increase in Risk From 

Other Contaminants? 

It is unlikely that the GWR will result 

in a significant increase in risk from 

other contaminants, although adding 

disinfection to currently nondisinfecting systems could result in 

some increased risk. When disinfection 

is first introduced into a previously 

undisinfected system, the disinfectant 

can react with pipe scale, causing 

increased risk from some contaminants 

and other water quality problems. 

Contaminants that could be released 

include lead, copper, and arsenic. It 

could also possibly lead to a temporary 

discoloration of the water as the scale is 

loosened from the pipe. These risks can 

be addressed by gradually phasing in 

disinfection to the system, by targeted 

flushing of distribution system mains, 

and by maintaining a proper corrosion 

control program. 

Using a chemical disinfectant could 

also result in an increased risk from 

disinfection byproducts (DBPs). Risk 

from DBPs has already been addressed 

in the Stage 1 Disinfection Byproducts 

Rule (DBPR) (USEPA, 1998c) and 

additional consideration of DBP risk has 

been addressed in the recently 

published final Stage 2 DBPR (USEPA, 

2006g). In general, GWSs are less likely 

to experience high levels of DBPs than 

surface water systems because they have 

lower levels of naturally occurring 

organic materials (generally represented 

by total organic carbon (TOC)) that 

contribute to DBP formation. For the 

most part, GWSs with high levels of 

TOC in their ground water source are 

located in States that already require 

GWSs to disinfect, therefore decreasing 

the chance that significant disinfection 

byproduct problems would result from 

this rule. 

I. What Are the Effects of the 

Contaminant on the General Population 

and Groups Within the General 

Population That Are Identified as Likely 

To Be at Greater Risk of Adverse Health 

Effects? 

EPA estimates that the average annual 

baseline illnesses and deaths associated 

with viruses in ground water are about 

185,000 and 3, respectively (Table VII–

4). The general population typically 

experiences GI illness when exposed to 

waterborne viral and bacterial 

pathogens, although other severe 

diseases such as kidney failure can also 

occur. Sensitive subpopulation 

exposure to these pathogens can result 

in more severe illness than in the 

general population, and sometimes 

death. 

Examples of sensitive subpopulations 

include pregnant women, infants, 

elderly (over 65), cancer patients, and 

AIDS patients (Gerba et al., 1996). Gerba 

estimates that these groups represent 

almost 20 percent of the U.S. 

population. The purpose of this section 

is to discuss the potential health effects 

associated with sensitive population 

groups, especially children, pregnant 

women, and the elderly. 

1. Risk of Acute Viral Illness to Children 

and Pregnant Women 

The risk of acute illness and death 

due to viral contamination of drinking 

water depends on several factors, 

including the age of the exposed 

individual. Infants and young children 

have higher rates of infection and 

disease from enteroviruses than other 

age groups (USEPA, 1999). Several 

enteroviruses that can be transmitted 

through water can have serious health 

consequences in children. Enteroviruses 

(which include poliovirus, 

coxsackievirus, and echovirus) have 

been implicated in cases of flaccid 

paralysis, myocarditis, encephalitis, 

hemorrhagic conjunctivitis, and 

diabetes mellitis (CDC, 1997; Modlin, 

1997; Melnick, 1996; Cherry, 1995; 

Berlin et al., 1993; Smith, 1970; Dalldorf 

and Melnick, 1965). 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, 2000e). 

a. Children’s Environmental Health. 

To comply with Executive Order 13045, 

EPA calculated the baseline risk and 

reduction of risk from waterborne viral 

illness and death for children as a result 

of this rule. To address the 

disproportionate risk of waterborne viral 

illness and death affecting children, 

EPA used age-specific morbidity data in 

the risk assessment. The risk assessment 

first estimated the proportion of the 

population that falls into several age 

categories for which data are available 

for two model viruses: Type A 

(represented by rotavirus data) and Type 

B (represented by enterovirus or 

echovirus data). 

While bacterial illnesses are not 

addressed in the quantified benefits 

analysis, EPA believes that the 

nonquantified benefits associated with 

consumption of undisinfected 

bacterially contaminated PWS well 

water could be significant in sensitive 

subpopulations. In an alternative 

analysis to the quantified benefits 

calculation, EPA estimated that roughly 

16,805 bacterial illnesses and 11 

bacterial deaths annually could be 

avoided in the general population. See 

Section 5.4.3 of the GWR EA for details 

of the analysis (USEPA, 2006d). 

Children and the elderly are particularly 

vulnerable to kidney failure (hemolytic 

uremic syndrome) caused by the 

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 

outbreaks 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). 

Type A viruses of high infectivity 

(Type A, e.g., rotavirus) 

disproportionately affect children less 

than three years of age. Thus, the age 

categories used in the hazard analysis 

were less than three years of age and 

greater than three years of age. Based on 

rotavirus data, it was assumed that 10 to 


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88 percent of children less than three 

years old would become ill once 

infected with high infectivity viruses 

and that 10 to 50 percent of the 

population over three years of age 

would become ill. 

For viruses of low-to-medium 

infectivity (Type B, e.g., echovirus), 

children are again disproportionately at 

risk of becoming ill once infected. For 

this virus type, the age categories used 

in the hazard analysis were less than 

five years of age, five to 19 years of age, 

and greater than 19 years of age. Based 

on echovirus data, EPA estimated that 

50 to 78 percent of children less than 

five years old would become ill once 

infected with low-to-medium infectivity 

viruses, 12 to 57 percent of children five 

to 19 years of age and 12 to 33 percent 

of people over 19 years of age would 

become ill once infected. 

In addition to illness, EPA also 

considered child mortality attributable 

to waterborne viral illness. For viruses 

of high infectivity (Type A), EPA 

estimates 0.00057 to 0.00073 percent of 

the ill population (including children) 

will die (Tucker et al., 1998). This value, 

based on rotavirus data from children 

less than five years of age (20 deaths 

from 2,730,000 to 3,500,000 illnesses), 

was applied to individuals of all ages 

because data for older individuals are 

not available. For low-to-medium 

infectivity viruses (Type B), EPA 

estimates that 0.92 percent of children 

less than one month of age who become 

ill will die based on data from Jenista et 

al. (1984), Modlin (1986) and Kaplan et 

al. (1983). For those individuals greater 

than one month in age, 0.02 percent 

who become ill will die based on the 

EPA assumption that one percent of 

enterovirus illnesses are severe and two 

percent of severe illnesses result in 

death. The low-to-medium infectivity 

viruses result in a higher mortality rate 

than the high infectivity viruses because 

they can cause more serious health 

effects. 

To estimate the benefits to children 

from this rule, the Agency calculated 

the number of endemic, acute viral 

illnesses and deaths avoided after rule 

implementation for children less than 

five years old and for children ages five 

through 15 years old. Table VII–13 

shows the estimates for annual illnesses 

avoided in young children due to this 

rule. Overall, this rule will result in 

about 2,780 fewer endemic, acute viral 

illnesses per year caused by Type A 

(represented by rotavirus data) and Type 

B (represented by enterovirus or 

echovirus data) viruses and 0.06 deaths 

in children less than five years of age. 

For older children aged five to 15 years 

of age, this rule will result in 4,856 

fewer acute illnesses per year (see 

Chapter 5 of the GWR EA (USEPA, 

2006d)). In addition to endemic, acute 

viral illnesses avoided, EPA estimates 

that there will be fewer deaths (less than 

one death) in children of all ages. 

Of the total annual avoided 

gastrointestinal illnesses predicted as 

the result of this rule, approximately 18 

percent (7,636) of the mean annual 

illnesses avoided occur in children aged 

15 years or younger. Children are 

disproportionately represented in the 

average annual number of illnesses 

avoided. Because children are often 

likely to be exposed via exposure 

pathways other than water in schools 

and day care centers (including fomites, 

respiratory, dermal, and person-toperson), the waterborne proportion 

probably does not dominate in total 

exposure but it may represent a 

significant fraction. More serious 

waterborne illnesses, such as hemolytic 

uremic syndrome (kidney failure), 

disproportionately affect children but 

this calculation only considers 

gastrointestinal illness. 

TABLE VII–13.—ANNUAL VIRAL ILLNESSES AVOIDED BY THE GWR IN CHILDREN, THE ELDERLY, AND THE

IMMUNOCOMPROMISED

Virus type Health 

effect 

Infants and 

young children 

<5 years old 

Elderly adults >65 

years old 

Immunocompromised 

(all ages) 

Total sensitive 

subgroups 

Type A (Rotavirus) ............................................ Illness ... 2,588 Illness: 5,559 ......... Illness: 126 ................. Illness: 8,465. 

Death ... 0.02 

Type B (Enterovirus or Echovirus) .................... Illness ... 191 Deaths: 0.10 ......... Deaths: 0.002 ............. Deaths: 0.15.

Death ... 0.04 

Note: Detail may not sum due to independent statistical analyses and rounding. The figures presented represent only the quantifiable benefits 

of the GWR. The nonquantified benefits are expected to comprise a significant portion of the overall benefits of the GWR and are presented in 

Section 5.4 of the GWR EA (USEPA, 2006d). The immunocompromised population includes bone marrow transplant recipients, AIDS patients, 

and organ transplant patients. 

Source: Number of Illnesses Avoided, Deaths Avoided, and Annual Benefits from GWR Model Output. 

2. Risk of Viral Illness to the Elderly and 

Immunocompromised 

The elderly are particularly at risk 

from diarrheal diseases (Glass et al., 

2000), such as those associated with 

waterborne microbial pathogens. Fiftythree 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 GWS resulted in four 

deaths, all among the elderly. One death 

occurred from hemolytic uremic 

syndrome (kidney failure); the others 

from gastrointestinal illness. Table VII–

13 shows that this rule’s estimates for 

avoided viral illnesses and deaths per 

year in the elderly population (> 65 

years old) are approximately 5,559 and 

0.1, respectively. 

Most epidemiological studies focus on 

nursing homes because the cluster of 

individuals improves data collection. 

Nursing home populations are typically, 

but not exclusively, elderly. Gerba et al. 

(1996) compiled data to show that, for 

the various waterborne microbial 

pathogens, nursing home mortality rates 

are significantly higher than in the 

general population. In Gideon, Missouri, 

a waterborne Salmonella typhimurium 

outbreak (Angulo et al., 1997) resulted 

in seven deaths from gastrointestinal 

illness, all among nursing home 

residents. 

Hospitalizations due to diarrheal 

disease are higher in the elderly (Glass 

et al., 2000). Average hospital 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). 

For another significant sensitive 

subpopulation, the 

immunocompromised, Gerba et al. 

(1996) summarized the literature and 

reported that enteric adenovirus and 

rotavirus are the two waterborne viruses 

most commonly isolated in the stools of 

AIDS patients. For patients undergoing 

bone-marrow transplants, several 


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studies cited by Gerba et al. (1996) 

reported mortality rates greater than 50 

percent among patients infected with 

enteric viruses. Table VII–13 shows that 

this rule’s estimates for avoided 

illnesses and deaths in the 

immunocompromised groups (all ages) 

are approximately 126 and 0.002, 

respectively. 

Overall, this rule will provide 

protection from waterborne viral and 

bacterial illness to both the general 

population and sensitive 

subpopulations. To capture the impact 

of the rule on both populations, the 

Agency considered the different 

severities of illness when valuing 

reductions in illness that will result 

from this rule. 

J. What Are the Uncertainties in the 

Risk, Benefit, and Cost Estimates for the 

GWR? 

Many uncertain values are used to 

derive estimates of baseline risk, risk 

reductions, and costs of this rule. Most, 

but not all, of these are mathematically 

modeled so that a ‘‘realization’’ is 

selected for them in each ‘‘uncertainty 

iteration’’ of EPA’s probabilistic 

economic analysis. These uncertainties 

then propagate through the derivation of 

final estimates so the total uncertainty 

of those final estimates can be 

understood. Each of those uncertainties, 

or the assumption that is made by not 

modeling it mathematically, is 

summarized in Sections 5.6 (for 

benefits) and 6.7 (for costs) in the GWR 

EA (USEPA, 2006d) for its importance 

and tendency to contribute 

systematically to an over-or 

understatement of the final estimate. 

The paragraphs that follow discuss the 

most important of these uncertain 

quantities. 

1. The Baseline Numbers of Ground 

Water Systems, Populations Served, and 

Associated Disinfection Practice 

The baseline number of systems is 

uncertain because of data limitations in 

the Safe Drinking Water Information 

System (SDWIS). For example, some 

systems use both ground and surface 

water, but because of other regulatory 

requirements, they are labeled in SDWIS 

as surface water systems. In addition, 

the SDWIS data on NCWSs do not 

reflect a consistent reporting convention 

for population served. Some States may 

report the population served by 

TNCWSs over the course of a year, 

while others may report the population 

served on an average day. For example, 

a State park may report the population 

served yearly instead of daily. Thus, 

SDWIS data may, in some cases, 

overestimate the daily population 

served. Also, SDWIS does not require 

States to provide information on current 

disinfection practices, resulting in 

uncertainty in the percentage of 

disinfecting systems providing 4-log or 

greater virus treatment. Although these 

different factors influencing the baseline 

estimates are uncertain, EPA believes 

that their relative degree of uncertainty 

in influencing the estimates within the 

GWR EA is small compared to other 

uncertain components of the Economic 

Analysis, so these are not treated 

probabilistically in the analysis. 

2. The Numbers of Wells Designated as 

More Versus Less Vulnerable 

For the purposes of the GWR EA, 

contaminated wells are classified as 

more or less vulnerable, which 

determines the assumptions used for the 

concentrations of virus as discussed in 

Section VII.B.1.c of this preamble. The 

numbers of systems falling into these 

two categories is uncertain and is also 

modeled as an uncertain variable. 

3. The Baseline Occurrence of Viruses 

and E. coli in Ground Water Wells 

EPA’s occurrence analysis is based on 

monitoring data from over 1,200 public 

drinking water supply wells that were 

tested for culturable virus, E. coli, or 

both. Compiled from 15 ground water 

surveys that were designed for different 

purposes, these wells are believed to be 

representative of ground water wells. 

Although the number of wells is large, 

the number of assays per well is small, 

and most wells were sampled only once 

for either virus or E. coli. Because of the 

limited amount of data, these data do 

not provide precise occurrence 

estimates. EPA’s analysis recognizes the 

limitations of the data, producing a large 

‘‘uncertainty sample’’ of estimates that 

are consistent with the data. This 

uncertainty sample is an input to the 

probabilistic economic analysis, where 

these uncertainties are combined with 

the uncertainties of other inputs to 

portray total uncertainty in the GWR 

cost and benefit estimates. EPA’s 

occurrence model includes 

concentration differences between more 

and less vulnerable wells, but applies 

the same hit rate model to both types of 

wells. Also, because of data limitations, 

EPA was unable to make an assessment 

of aquifer sensitivity as part of the final 

rule and, therefore, no difference in hit 

rates or concentration levels between 

sensitive and nonsensitive wells is 

assumed. The GWR EA addresses 

uncertainty about these assumptions in 

a qualitative discussion (USEPA, 

2006d). 

4. For the Sanitary Survey Provisions, 

the Percentage of Systems Identified as 

Having Significant Deficiencies, the 

Percentage of These Deficiencies That 

Are Corrected, and State Costs for 

Conducting Surveys 

For the sanitary survey provisions, 

EPA estimated the impacts associated 

with well deficiencies. EPA used data 

from the 1998 ASDWA survey to 

estimate the percentage of wells with 

deficiencies (ASDWA, 1997). To 

estimate benefits, EPA assumed that if a 

correction of a well defect occurred at 

a virally contaminated well, some, but 

not all of these virally contaminated 

wells would no longer have viral 

contamination. EPA used an uncertainty 

distribution for this estimate. 

To estimate costs for significant 

deficiencies detected at or near the 

source, EPA chose two representative 

corrective actions to use in the cost 

model: replacement of a sanitary well 

seal or rehabilitation of an existing well. 

Because the corrections of significant 

deficiencies are dependent upon the 

deficiencies defined as significant by 

States and the conditions of specific 

systems, both of which are highly 

variable, EPA used a high and low 

scenario to bound the cost estimates. 

The low-cost scenario assumes a greater 

percentage of the systems with 

significant deficiencies will have 

deficiencies that are less expensive to 

correct (e.g., more systems will have to 

replace their sanitary well seal than will 

have to perform a complete 

rehabilitation of their well). This high/ 

low bounding provides an estimate of 

the uncertainty with respect to the 

percentages of each type of defect to be 

corrected. 

While the sanitary survey provisions 

will also result in identification and 

correction for deficiencies associated 

with treatment or distribution system 

deficiencies, due to insufficient data, 

EPA did not quantify either costs or 

benefits for these types of deficiencies. 

In the GWR EA, EPA qualitatively 

discusses these impacts (USEPA, 

2006d). 

Finally, EPA assumes that most States 

are already conducting sanitary surveys 

that include the eight required elements, 

and that many States are already 

conducting sanitary surveys for GWSs 

that meet the frequency requirements in 

the GWR, so EPA estimated incremental 

costs for these activities in only a 

relatively small subset of States. 


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5. The Predicted Rates at Which Virally 

Contaminated (and Non-Contaminated) 

Wells Will Be Required To Take Action 

After Finding E. coli Ground Water 

Sources 

EPA’s occurrence model estimates the 

percentage of wells that have only virus 

present, both E. coli and virus present, 

or only E. coli present. The occurrence 

model also includes parameters that 

describe how often contaminated wells 

actually have the contaminant present. 

For example, some contaminated wells 

have E. coli present less than one 

percent of the time, while others have 

E. coli present more than 10 percent of 

the time (some of which will also have 

sometime viral presence). When E. colicontaminated wells are tested for the 

first time, those with frequent E. coli 

occurrence are the most likely to be 

identified as contaminated. As these 

problems are addressed and corrected, 

there should be fewer and fewer wells 

with frequent E. coli occurrence (as well 

as viral occurrence since a fraction of E. 

coli wells will also have sometime viral 

presence; see Section III.C.2 for further 

elaboration). This diminishing rate of 

fecal contamination identification is 

included in the GWR EA (USEPA, 

2006d). Uncertainty about the 

diminishing rate is due to uncertainty 

about the EPA’s estimates of how often 

E. coli occurs in contaminated wells. As 

with other key uncertain inputs, this 

uncertainty is represented by an 

uncertainty sample of the relevant 

parameters. Again, EPA assumes no 

difference based on vulnerability or 

sensitivity. The GWR EA qualitatively 

discusses uncertainty of this assumption 

(USEPA, 2006d). 

Undisinfected wells are subjected to 

triggered source water monitoring. The 

rate at which triggered source water 

monitoring identifies a well as fecallycontaminated depends on both the 

fraction of time that E. coli is present in 

the well and the frequency at which the 

well is sampled. Data verification (DV) 

data on total coliform occurrence in 

distribution systems provide the basis 

for estimates of sampling frequency in 

different types and sizes of systems. 

Although the data are limited, EPA has 

not modeled these as uncertain 

estimates. Compared to other uncertain 

parameters, these have relatively little 

uncertainty and are expected to make 

only minor contributions to the total 

uncertainty in the GWR EA. 

EPA also did not consider the cost 

impacts of additional fecal indicator 

sampling following triggered source 

water monitoring on corrective action 

costs. The analysis assumes that for 

every triggered source water monitoring 

positive, at least one additional fecal 

indicator sample will also be positive, 

resulting in corrective action. The 

rationale for this assumption is 

explained in Chapter 6 of the GWR EA. 

However, it is possible that some 

systems will not have a positive 

additional fecal indicator sample and 

will therefore not incur costs for 

corrective action. Accounting for this 

would reduce the costs of the rule 

associated with corrective actions and, 

to the extent that these systems actually 

do have viral or bacterial pathogens 

present, would reduce the benefits of 

the rule as well. 

EPA assumes that the occurrence of 

fecal contamination will remain 

constant throughout the implementation 

of the rule. However, this might not be 

the case if increased development 

results in fecal contamination of a larger 

number of aquifers in areas served by 

GWSs or if other rules, such as 

Concentrated Animal Feeding 

Operations (CAFO) and Class V 

Underground Injections Control (UIC) 

Well regulations, result in decreased 

fecal contamination. This uncertainty is 

not mathematically modeled in the 

GWR Economic Analysis. 

6. The Infectivity of Echovirus and 

Rotavirus Used To Represent Viruses 

That Occur in Ground Water 

EPA does not have dose-response data 

for all viruses associated with previous 

ground water disease outbreaks. For 

viral illness, the Agency used echovirus 

and rotavirus as surrogates for all 

pathogenic viruses from fecal 

contamination that can be found in 

ground water. By using these two 

viruses, the Agency is capturing the 

effects of both high infectivity (Type A) 

viruses that cause mild illness and lowto-medium infectivity (Type B) viruses 

that may cause more severe illness but 

not the range of infectivity within each 

type. Further, there is additional 

uncertainty in the dose-response 

functions used, even for these two 

viruses. The dose-response relationship 

was modeled in two steps. First, 

infectivity, or the percentage of people 

in the different age groups who become 

infected after exposure to a given 

quantity of water with a given 

concentration of viruses, was estimated. 

Then morbidity, or the percentage of 

infected people who actually become ill, 

was estimated. EPA models uncertainty 

for morbidity within different age 

categories and differences in morbidity 

across different age categories 

(variability). 

7. The Costs of Illnesses Due to 

Ingestion of Contaminated Ground 

Water 

There is also uncertainty in the 

valuation of risk reduction benefits. For 

this analysis, EPA used a cost of illness 

(COI) approach based on the direct 

medical care costs as well as the 

indirect costs of becoming ill. However, 

there is uncertainty in these estimates 

and variability in the COI across 

populations and geographic regions. 

8. The Costs of Taking Action After 

Finding E. coli in Ground Water Sources 

EPA recognizes that there are both 

variability and uncertainty in unit cost 

estimates for treatment. Variability is 

expected in the actual costs that will be 

experienced by different water systems 

with similar flows installing the same 

treatment technology. Otherwise similar 

systems may experience different 

capital and/or O&M costs due to sitespecific factors. Inputs to unit costs 

such as water quality conditions, labor 

rates, and land costs can be highly 

variable and increase the system-tosystem variability in unit costs. In 

developing the unit cost estimates, there 

is insufficient information to fully 

characterize what the distribution of 

this variability will be on a national 

scale for all of the treatments and all 

possible conditions. 

The unit costs for the GWR EA are 

developed as average or representative 

estimates of what these unit costs will 

be nationally. That is, in developing 

unit costs, design criteria for the 

technologies were selected to represent 

typical, or average, conditions for the 

universe of systems. As a result, there is 

uncertainty inherent in these unit cost 

estimates since they are based on 

independent assumptions with 

supporting data and vendor quotes, 

where available, rather than on a 

detailed aggregation of State, regional, 

or local estimates based on actual field 

conditions. EPA quantifies the 

uncertainty in these national average 

unit cost factors for specific 

technologies. The percentage 

uncertainty bounds used to characterize 

unit costs were developed based on 

input from engineering professionals 

and reflect recommendations from the 

National Drinking Water Advisory 

Council (NDWAC, 2001) in its review of 

the national cost estimation 

methodology for the Arsenic Rule. EPA 

believes that the uncertainties in capital 

and O&M costs for a given treatment 

technology are independent of one 

another and that uncertainties across all 

technologies are independent. 


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9. Nonquantifiable Benefits 

A major uncertainty concerns the 

number of baseline bacterial illnesses 

caused by ground water contamination. 

The bacterial risk could not be modeled 

because of the lack of occurrence and 

dose-response data; therefore, the 

Agency was unable to include these 

benefits in the primary analysis. Many 

other nonquantifiable endpoints (as 

discussed in Section VII.C.4 of this 

preamble and in the GWR EA Chapter 

5 (USEPA, 2006d) cause further 

uncertainty. In summary, the quantified 

benefits may be small as compared with 

the total benefits. EPA’s analysis of 

benefits from avoided bacterial illnesses 

and deaths suggests that these benefits 

could exceed the monetized benefits by 

a factor of five. 

10. Optional Assessment Source Water 

Monitoring 

The Agency was not able to estimate 

the benefits or costs resulting from the 

optional assessment source water 

monitoring program. States can 

determine which systems they deem 

most vulnerable to fecal contamination 

and require these systems to conduct 

assessment source water monitoring. 

Systems would incur additional costs 

from monitoring and reporting results as 

well as any corrective action associated 

with fecal indicator-positives. States 

would incur additional costs for 

determining what systems would be 

required to monitor, assisting systems 

with corrective action decisions, and 

recordkeeping. The types of illnesses 

avoided would be similar to those 

already described in this preamble such 

as reduced viral and bacterial illness. 

11. Corrective Actions and Significant 

Deficiencies 

The Agency also did not develop 

costs for corrective actions for all 

conceivable significant deficiencies that 

a system may encounter. Instead, 

representative actions that span the 

range of low cost to expensive actions 

were used as shown in Table VII–10. 

The corrective actions that are a result 

of significant deficiencies identified 

during sanitary surveys do not include 

the ones performed within the treatment 

plant or in the distribution system due 

to lack of adequate data. Exclusion of 

these costs from the cost analysis results 

in an underestimate of potential rule 

costs, though the magnitude of the 

underestimate is unknown. Data 

limitations also exclude quantifying any 

benefits that may be realized from these 

corrective actions. More information 

regarding these costs and benefits can be 

found in the GWR EA (USEPA, 2006d) 

(see Chapter 6.6 for cost and Chapter 

5.4.7 and 5.4.8 for benefits). 

12. Uncertainty Summary 

Overall, EPA recognizes that there is 

uncertainty in various parts of its 

estimates. The Agency has, however, 

been careful to use the best available 

data to account for uncertainty 

quantitatively when possible, and to 

avoid any consistent biases in 

assumptions and the use of data. The 

primary known bias is that some 

benefits and costs have not been 

quantified, and therefore are not 

included in the quantitative comparison 

of regulatory alternatives. However, as 

explained above and in the EA, EPA 

believes that the nonquantified benefits 

are significantly greater than the 

quantified benefits. In summary, EPA 

believes that the analyses presented 

represent a solid foundation for the 

decisions made for this rule. 

K. What Is the Benefit/Cost 

Determination for the GWR? 

As required by the SDWA, at the time 

of proposal, the Agency determined that 

the benefits of this rule justify the costs. 

In making this determination, EPA 

considered both quantified and 

nonquantified benefits and costs as well 

as the other components of the HRRCA 

outlined in section 1412 (b)(3)(C) of the 

SDWA. 

For the final rule, as shown in Table 

VII–14, for the regulatory alternative 

being finalized in this rule, the 

annualized mean quantified benefits are 

approximately $20 million ($10 million 

using traditional cost-of-illness values) 

and the annualized mean quantified 

costs are approximately $62 million 

using a three percent discount rate ($17/ 

$9 million and $62 million, 

respectively, using a seven percent 

discount rate). Overall, the GWR will 

reduce the risk of fecal contamination 

reaching the consumer. The monetized 

costs of these provisions were compared 

to the monetized benefits that result 

from the reduction in some viral 

illnesses and deaths. In addition, other 

non-monetized benefits further justify 

the costs of this rule. For example, 

including bacterial illness would 

significantly increase the benefits 

without any increases in costs. 

Table VII–15 shows the net benefits 

for this rule as well as the three 

regulatory alternatives considered. The 

net benefits include only the monetized 

values (i.e., nonquantified costs and 

benefits are not considered). The 

nonquantified benefits are likely to be 

significantly greater than the quantified 

benefits (and also much greater that the 

nonquantified costs). Thus, the net 

benefits of each of the options may be 

higher than shown in these estimates. 

Nonquantified costs are also not 

included. 

TABLE VII–14.—ESTIMATED ANNUALIZED NATIONAL BENEFITS AND COSTS FOR THE GWR 

[$Millions, 2003$] 

3% Discount rate 7% Discount rate 

Mean 

90 percent confidence bound 

Mean 

90 percent confidence bound 

Lower 

(5th %ile) 

Upper 

(95th %ile) 

Lower 

(5th %ile) 

Upper 

(95th %ile) 

Enhanced COI: 

Benefits ............................................. $19.7 $6.5 $45.4 $16.8 $5.5 $38.6 

Costs ................................................. 61.8 45.2 81.4 62.3 46.1 81.6 

Net Benefits ...................................... ¥42.1 Note 1 Note 1 ¥45.5 Note 1 Note 1 

Traditional COI: 

Benefits ............................................. 10.0 2.2 27.0 8.6 1.9 22.9 

Costs ................................................. 61.8 45.2 81.4 62.3 46.1 81.6 

Net Benefits ...................................... ¥51.8 Note 1 Note 1 ¥53.7 Note 1 Note 1 

Nonquantified Benefits ...................... Decreased incidence of other acute viral disease endpoints. 

Decreased incidence of bacterial illness and death. 

Decreased incidence of chronic bacterial or viral illness sequellae. 


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TABLE VII–14.—ESTIMATED ANNUALIZED NATIONAL BENEFITS AND COSTS FOR THE GWR—Continued 

[$Millions, 2003$] 

3% Discount rate 7% Discount rate 

Mean 

90 percent confidence bound 

Mean 

90 percent confidence bound 

Lower 

(5th %ile) 

Upper 

(95th %ile) 

Lower 

(5th %ile) 

Upper 

(95th %ile) 

Decreased incidence of waterborne disease outbreaks and epidemic illness. 

Decreased illness through minimizing treatment failures or fewer episodes with inadequate treatment. 

Potential decreased use of bottled water and point-of-use devices (material costs). 

Decreased time spent on averting behavior. 

Avoided costs associated with outbreak response. 

Perceived improvement in drinking water quality and reduction in risk associated with ingestion. 

Benefits from optional Assessment Source Water Monitoring. 

Benefits from correction of sanitary survey deficiencies identified in the distribution systems and 

treatment plant. 

Nonquantified Costs ......................... Costs for optional Assessment Source Water Monitoring. 

Costs from correction of sanitary survey deficiencies identified in the distribution systems and 

treatment plant. 

Some land costs depending on the treatment technology. 

Cost for five additional samples but this is small compared to the overestimate of cost for the initial 

fecal-indicator sample that systems would take. 

Costs for compliance monitoring at some systems that already disinfect. 

Note 1: Because benefits and costs are calculated using different model modules, bounds are not calculated on net benefits. 

Note 2: The Traditional COI only includes valuation for medical costs and lost work time (including some portion of unpaid household production). The Enhanced COI also factors in valuations for lost personal time (non-worktime) such as child care and homemaking (to the extent not 

covered by the traditional COI), time with family, and recreation, and lost productivity at work on days when workers are ill but go to work 

anyway. 

TABLE VII–15.—ANNUALIZED NET BENEFITS ($MILLIONS, 2003$) BY REGULATORY ALTERNATIVE

Rule alternative 

Annualized value 

3% discount rate 

(dollars) 

7% discount rate 

(dollars) 

Enhanced COI: 

Alternative 1 ............................................... ¥11.7 ¥12.4 

Final Rule ................................................... ¥42.1 ¥45.5 

Alternative 3 ............................................... ¥46.6 ¥51.2 

Alternative 4 ............................................... ¥616.2 ¥603.4 

Traditional COI: 

Alternative 1 ............................................... ¥13.5 ¥13.8 

Final Rule ................................................... ¥51.8 ¥53.7 

Alternative 3 ............................................... ¥57.1 ¥60.1 

Alternative 4 ............................................... ¥650.9 ¥633.8 

Nonquantified Benefits ............................... Decreased incidence of other acute viral disease endpoints. 

Decreased incidence of bacterial illness and death. 

Decreased incidence of chronic bacterial or viral illness sequellae. 

Decreased incidence of waterborne disease outbreaks and epidemic illness. 

Decreased illness through minimizing treatment failures or fewer episodes with inadequate 

treatment. 

Potential decreased use of bottled water and point-of-use devices (material costs). 

Decreased time spent on averting behavior. 

Avoided costs associated with outbreak response. 

Perceived improvement in drinking water quality and reduction in risk associated with ingestion. 

Benefits from optional Assessment Source Water Monitoring. 

Benefits from correction of sanitary survey deficiencies identified in the distribution systems and 

treatment plant. 

Nonquantified Costs ................................... Costs for optional Assessment Source Water Monitoring. 

Costs from correction of sanitary survey deficiencies identified in the distribution systems and 

treatment plant. 

Some land costs depending on the treatment technology. 

Cost for five additional samples but this is small compared to the overestimate of cost for the 

initial fecal-indicator sample that systems would take. 

Cost for compliance monitoring at some systems that already disinfect. 


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In addition to examining the net 

benefits of this rule, the Agency used 

several other techniques to compare 

benefits and costs. For example, Table 

VII–16 shows the cost of the rule per 

viral illness avoided. This cost 

effectiveness measure is another way of 

examining the benefits and costs of the 

rule but should not be used to compare 

alternatives because an alternative with 

the lowest cost per illness avoided may 

not result in the greatest net benefits. 

The cost effectiveness analysis, as with 

the net benefits, is limited because the 

Agency was able to only partially 

quantify and monetize the benefits of 

the GWR. This rule achieves the lowest 

cost per viral illness avoided. 

Additional information about this 

analysis and other methods used to 

compare benefits and costs can be found 

in Chapter 8 of the GWR EA (USEPA, 

2006d). 

TABLE VII–16.—COST PER CASE OF VIRAL ILLNESS OR DEATH AVOIDED BY REGULATORY ALTERNATIVE

[2003$] 

Rule alternative 

Cost per viral illness avoided 

3% 

(dollars) 

7% 

(dollars) 

Alternative 1 ............................................................................................................................................................. 2,045 2,044 

Final Rule ................................................................................................................................................................. 1,476 1,488 

Alternative 3 ............................................................................................................................................................. 1,495 1,527 

Alternative 4 ............................................................................................................................................................. 4,420 4,284 

Note: Calculated using mean costs of illness avoided. 

Overall, the measures described above 

are very close for the Final Rule and 

Alternative 3 and EPA believes that the 

nonquantified benefits of the rule would 

result in positive net benefits for either 

option. The Final Rule allows States to 

implement the assessment source water 

monitoring provision, which would 

have been mandatory if EPA had chosen 

Alternative 3, on a voluntary basis. The 

final GWR is more flexible, targeted, and 

protective than Alternative 3 (see 

Section VII.A of this preamble and 

Chapter 8 of the GWR EA (USEPA, 

2006d) for more details). The level at 

which additional costs will be incurred 

and benefits realized under the 

voluntary provision is dependent on the 

rate at which States elect to adopt the 

provisions, and thus is not quantified as 

part of the Economic Analysis. 

L. What Were Some of the Major 

Comments Received on the Economic 

Analysis and What Are EPA’s 

Responses? 

1. Costs 

EPA requested comment on all 

aspects of cost analysis for the proposed 

GWR, particularly on the flow estimate 

for NTNCWSs and TNCWSs and 

handling mixed systems. In addition to 

these two issues, EPA also received 

numerous comments on the following 

analyses: sanitary survey costs, estimate 

of treatment baseline, costs of corrective 

actions, and compliance costs for small 

systems or NCWSs. 

a. Flow estimate for NTNCWSs and 

TNCWSs. EPA received a few comments 

on NTNCWS and TNCWS flow 

estimates. Some commenters indicated 

that the alternative approach described 

in the preamble of the proposed rule 

would lead to greater disparities from 

the true values. The other commenters 

supported using the alternative 

approach. For this rule, EPA continues 

to apply the CWS regression equations 

to NCWSs, recognizing that this may 

overestimate flow and, therefore, costs. 

This overestimate is addressed as part of 

the uncertainties, which is discussed in 

Chapter 4 of the GWR EA (USEPA, 

2006d). Further discussion of the 

alternative approach is also presented 

there. 

b. Mixed systems. EPA received 

comments that regulatory impacts on 

mixed systems were not adequately 

characterized because either their costs 

were underestimated or the 

methodology for deriving the costs was 

unclear. Since the available data was 

insufficient to directly account for 

ground water entry points in mixed 

systems, EPA based the cost estimate for 

mixed systems on the primarily ground 

water mixed system inventory report. 

Primarily ground water mixed systems 

are systems using ground water for more 

than 50 percent of their source water; 

the remainder of their source water is 

surface water. The primarily ground 

water-mixed CWSs identified by this 

calculation were added to the solely 

GWS inventory to produce the total 

baseline number of GWSs used in the 

economic analysis. Because NTNCWSs 

and TNCWSs are typically a single 

building or located in a small area, a 

simplifying assumption was made for 

this analysis that all NCWSs draw from 

a single source water type. 

The total baseline number of GWSs is 

treated as ground water-only systems 

throughout subsequent analyses. This 

methodology, treating mixed systems as 

ground water-only systems, may 

overestimate costs and benefits (i.e., 

some surface water entry points are now 

counted as ground water entry points). 

However, the ground water entry points 

in the excluded mixed surface water 

inventory (those mixed systems using 

less than 50 percent ground water) are 

not included in the analysis, potentially 

underestimating costs and benefits. The 

contrasting over- and under-accounting 

for ground water entry points are 

expected to offset one another to some 

extent in the cost and benefit analyses. 

Data are not available to quantify the 

direction or magnitude of the final effect 

on overall national cost estimates, but 

the effect is expected to be small. 

Chapter 4 of the GWR EA (USEPA, 

2006d) contains a detailed description 

of the methodology for impact analysis 

of mixed systems. 

c. Sanitary survey costs. EPA received 

comments that the sanitary survey costs 

were inadequately estimated because of 

lack of considerations of the surveys 

currently performed by States and travel 

times needed for conducting surveys. 

The sanitary survey cost estimates used 

in this rule analysis have been updated 

based on data that became available 

after the proposed GWR. For the 

proposed GWR, EPA used the same unit 

costs as the ones used in a previous 

economic analysis (IESWTR) for 

estimating costs of full sanitary surveys. 

Fifty percent of full survey costs was 

applied to all systems as the 

incremental costs resulting from the 

GWR sanitary survey provision. This 

percentage was used to account for the 

more comprehensive survey coverage 

(i.e., evaluation of eight elements) under 

the GWR than under existing 

requirements of the TCR. 

For the final rule, EPA revised its cost 

analysis for conducting sanitary surveys 


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based on new information from States. 

First, EPA revised its estimates for 

conducting full sanitary surveys 

specifically for GWSs with and without 

treatment. Second, EPA estimated the 

number of additional full sanitary costs 

(including travel time costs) that would 

result from the higher frequency of 

sanitary surveys required under the 

GWR, over the number that is currently 

being implemented. This number of 

additional sanitary surveys was 

multiplied by the sanitary survey unit 

costs to estimate national costs for this 

effect. 

Third, for those sanitary surveys 

already being conducted, EPA estimated 

the percentage of systems for which 

sanitary surveys would need to be 

increased in scope to ensure that all 8 

elements were being implemented. 

Because all States currently have 

sanitary surveys in place under the 

IESWTR, TCR, or other State programs, 

most States are now conducting sanitary 

surveys at the frequencies and scope 

required by the GWR. The revised 

sanitary survey costs thus assume no 

incremental unit costs in most States 

and are substantially lower than the 

estimates costed for the proposed GWR. 

Chapter 6 of the GWR EA (USEPA, 

2006d) contains a detailed discussion of 

sanitary survey costing assumptions. 

d. Treatment baseline. EPA received 

comments that the percentage of 

disinfecting systems currently achieving 

4-log virus inactivation was 

overestimated. For the proposed rule, 

EPA based the estimate of systems 

achieving 4-log inactivation (77 percent) 

on the data from the AWWA 

disinfection survey for community 

GWSs. EPA recognizes the limited data 

resources; AWWA data was the only 

source available on a national level and 

the disinfection rate estimate used in 

the proposed rule is likely to bias high 

due to relatively small sample size and 

question complexity for the survey. 

In the final GWR EA, EPA reevaluated the AWWA data and made a 

conservative assumption that those 

community GWSs providing insufficient 

information for the CT calculation in the 

AWWA survey are not currently 

achieving 4-log virus inactivation. As a 

result, the 4-log disinfection rate was 

revised downward to 52 percent. A 

similar change was made for NCWSs. 

Chapter 4 of the GWR EA (USEPA, 

2006d) provides the detailed discussion 

of current disinfection rates. 

e. Corrective action costs. EPA 

received comments that corrective 

action costs were underestimated, 

especially the costs for installing 

disinfection units. The commenters 

questioned the cost estimates of the 

additional land required and the 

addition of storage tanks for achieving 

sufficient CT values for 4-log virus 

inactivation. EPA believes that the unit 

costs of technologies provided in the 

Technology and Cost Document for the 

Final Ground Water Rule (USEPA, 

2006h) (T&C document) are adequate to 

derive the costs for complying with the 

GWR corrective action provisions 

because the costs were derived using the 

best available published data, vendor 

estimates and best professional 

judgment. 

EPA understands that some 

technologies used to comply with this 

rule will not fit within the existing plant 

footprints for some systems. When land 

costs become expensive, systems have 

the flexibility to consider other nontreatment options such as well 

rehabilitation or purchasing water. EPA 

further recognizes the land costs as part 

of nonquantified costs in the GWR EA 

(USEPA, 2006d). 

The T&C document presents the unit 

costs of disinfection apart from the unit 

costs for storage tanks because 

consultation with the field experts 

indicates that some systems have 

existing storage tanks or certain lengths 

of pipes before the first costumers. 

Systems that do not have existing 

storage tanks will need to consider the 

costs for them in cases when they would 

need to meet the CT values for 4-log 

inactivation of viruses. The detention 

times in existing facilities could be 

sufficient for achieving the 4-log CT 

values with disinfectant doses within a 

typical range. For these cases, EPA 

assumes that no additional storage will 

be required for installing disinfection or 

that an increase of disinfectant doses 

will be feasible for increasing viral 

disinfection levels to 4-logs. 

EPA also recognizes that disinfection 

and conducting compliance monitoring 

may not be preferred by some systems 

(particularly for small systems) because 

of distribution system size and 

configuration or operational complexity 

(including compliance monitoring) and 

costs. After further consultation with 

State representatives, EPA revised the 

compliance forecasts for this rule by 

lowering the percentages of systems 

taking treatment actions (and raising 

percentages of systems taking nontreatment actions) and adding a range of 

estimates to quantify the uncertainty 

around the compliance forecasts. The 

consultation also resulted in the 

addition of interim disinfection for 

systems taking corrective actions due to 

a fecal indicator-positive ground water 

source sample. This is because some 

immediate protection measures may 

have to be in place prior to completing 

corrective actions. Chapter 6 of the GWR 

EA (USEPA, 2006d) contains a detailed 

discussion of the corrective action costs. 

f. Compliance costs for small systems 

or NCWSs. Some commenters 

questioned whether EPA appropriately 

considered the costs to small systems. 

As part of the GWR regulatory 

development process, EPA participated 

in extensive consultations with small 

system representatives to develop riskbased rule requirements that would 

minimize the time and financial burden 

on small systems. To address concerns 

over the potential cost of additional 

monitoring for small systems, the GWR 

leverages the existing TCR monitoring 

framework to the extent possible (e.g., 

by using the results of the TCR 

monitoring to determine if triggered 

source water monitoring is required and 

by allowing small systems to use TCR 

repeat samples to satisfy GWR 

requirements). In addition, the 

implementation schedule for the 

sanitary survey requirement is staggered 

(e.g., every three to five years for CWSs 

and every five years for NCWSs), 

providing some relief for small systems 

since there are many more small NCWSs 

than CWSs. In addition to the targeted 

requirements for minimizing small 

systems burden, financial assistance to 

small systems may be available from 

programs administered by EPA or other 

Federal agencies (http://www.epa.gov/ 

safewater/dwsrf/index.html). 

Some commenters noted that systems 

may break into smaller units to fall 

below SDWA regulatory thresholds. 

Specifically, they noted that if a system 

is no longer classified as a PWS, it 

would be able to opt out of the GWR 

requirements. However, EPA believes 

that systems would most likely 

consolidate with other systems to defray 

costs rather than split up and lose 

economies of scale and put the public 

health at risk. Systems would also have 

to consider the transaction costs 

associated with dissolving into smaller 

units such as drilling new wells and 

separating distribution systems. 

EPA also received a number of 

comments questioning if the Agency 

considered the costs to NCWSs (i.e., 

NTNCWSs and TNCWSs). EPA did 

consider the costs to NTNCWSs and 

TNCWSs. The baseline number of 

systems subject to GWR requirements 

was derived from all CWSs, NTNCWSs, 

and TNCWSs listed in the SDWIS 

inventory. The new occurrence database 

also includes NCWSs. Costs were 

estimated by system size and type 

corresponding to applicable GWR 

requirements and schedules and typical 

operating characteristics (e.g., 

population served, treatment in place, 


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flows, etc.). Detailed descriptions of all 

costing procedures are presented in the 

GWR EA (USEPA, 2006d). More 

specifically, NTNCWS and TNCWS cost 

estimates are presented by system size 

in Exhibit 6.40 of the GWR EA. 

2. Benefits 

a. Use of occurrence data in risk 

assessment. Some commenters 

questioned the basis for EPA using the 

data from the Lieberman et al. (2002) 

and Abbaszadegan (Abbaszadegan, 2002 

and Abbaszadegan et al., 1999a–c and 

2003) studies to represent national 

microbial occurrence in the risk 

assessment. Issues raised included use 

of the studies to represent all CWSs and 

NCWSs on a national level, use of the 

Abbaszadegan et al. data set to represent 

‘‘properly constructed wells,’’ and use 

of the Lieberman data set to represent 

‘‘poorly constructed wells.’’

Upon re-examination of all available 

occurrence data, EPA has made several 

changes to the occurrence analysis used 

to support the risk assessment. The 

Agency has made changes to achieve 

better representation of viral and fecal 

indicator occurrence among all PWS 

wells in the U.S. as described in Section 

VII.B. 

Data from all the studies used in the 

occurrence analysis of the GWR EA 

were cited in the NODA (USEPA, 2006e) 

and made publicly available. EPA 

believes that use of occurrence data 

from the cited studies in Section VII.A 

rather than using only the two studies 

used in the GWR EA under the proposal 

(Lieberman et al., 2002; Abbaszadegan, 

2002 and Abbaszadegan et al., 1999a–c 

and 2003) provides a better national 

estimate of intermittent enterovirus 

occurrence in support of the GWR risk 

assessment. 

Under the proposed rule, EPA used 

the Lieberman et al. (2002) data set to 

estimate enteric virus occurrence for 

poorly constructed wells and the 

Abbaszadegan (Abbaszadegan, 2002; 

Abbaszadegan et al., 1999a–c and 2003) 

data set to estimate enteric virus 

occurrence in properly constructed 

wells. In this rule, due to data 

limitations, EPA assumes the same 

enterovirus occurrence and percent time 

of viral presence (as described in 

Section VII.B of this preamble) for all 

wells. 

In this rule, EPA uses the terminology 

‘‘more vulnerable’’ and ‘‘less 

vulnerable’’ wells as categories for 

differing enteric virus concentration 

assumptions in differing groups of 

wells. Since the wells sampled from the 

Lieberman et al. (2002) data were 

selected because of likely vulnerability 

to fecal contamination, the enteric virus 

concentration data from Lieberman et 

al. (2002) is assumed to be characteristic 

of ‘‘more vulnerable’’ wells. Since the 

wells from the Abbaszadegan et al. 

(2002) and Lindsey et al. (2002) studies 

were not selected with a bias toward 

greater likelihood of fecal 

contamination, enteric viral 

concentrations from these two studies 

were assumed to be characteristic of 

‘‘less vulnerable’’ wells. A more 

complete description of this analysis is 

available in Chapters 4 and 5 of the 

GWR EA (USEPA, 2006d). 

b. Variability and uncertainty. Some 

commenters suggested that EPA could 

do more to address uncertainty and 

variability when calculating the benefits 

of this rule. As a result of these 

comments, EPA re-evaluated the data 

used to support the proposed GWR and 

the newer data published since the 

proposal. EPA determined that the 

values and/or analysis used in the 

proposed rule should be revised to 

better capture variability and 

uncertainty. The following discussion 

describes the significant changes that 

were made in the analysis supporting 

this rule as a result of the public 

comments and EPA’s re-analysis. 

EPA has significantly revised its 

modeling of virus and indicator (E. coli) 

occurrence in ground water sources of 

drinking water in response to public 

comments. Section VII.B describes 

additional surveys and their use to 

produce a national assessment of 

occurrence. The modeling framework 

features probabilistic treatments of both 

variability and uncertainty. 

In this rule, EPA modified the 

mathematical expression that describes 

the human challenge studies with 

infectious rotavirus (infectivity of the 

virus). The purpose of the challenge 

study was to determine the rotavirus 

dose required to cause infection in 

humans. Previously, EPA used an 

approximation to the exact Beta-Poisson 

distribution in describing the doseresponse data to simplify the MonteCarlo simulation computational 

requirements. EPA’s primary analysis 

now recognizes that the approximation 

is poor for some combinations of dose 

and parameter values and when used to 

predict low dose risk. As a result, EPA 

is using the exact expression for this 

rule. In an alternative analysis, EPA 

utilizes only data from the lowest dose 

used in the study. That dose (0.9 

infectious units) is nearest the most 

relevant environmental number 

ingested: exactly one infectious unit. An 

exponential dose-response model is 

applied in the alternative analysis and 

the small number of subjects (seven 

exposed at this dose) results in 

considerable uncertainty about the 

model parameter. 

In this rule, EPA maintains as its 

primary analysis a Beta-Poisson doseresponse model (Pareto approximation) 

utilizing the full echovirus data set but 

now includes an alternative analysis in 

which an exponential model is utilized 

with data from all but the two highest 

dose levels. Subjects who were not 

infected at the high dose levels 

demonstrate that different individuals 

have different levels of susceptibility (a 

feature of the Beta-Poisson model), but 

without the high dose data, the 

remaining subjects appear equally 

susceptible (a feature of the exponential 

model). The alternative analysis 

predicts significantly lower risk at 

environmental exposure levels. EPA’s 

two analyses demonstrate considerable 

uncertainty with respect to model and 

data selection. 

In this rule, EPA revised the 

morbidity value for rotavirus illness in 

adults. The Agency now recognizes that 

the variability in this value is 

considerable and has included a range 

of uncertainty in the morbidity estimate. 

Because of limited data on common 

source rotavirus outbreaks involving 

adults, under the proposal, EPA had 

assumed that most adults remain 

immune due to multiple repeat 

infections, or if infected, do not often 

become ill. Under the proposal, EPA 

used a low value for the adult rotavirus 

morbidity rate (0.10). However, EPA reexamined the Ward et al. (1986) data 

and concluded that one-half of the 

subjects in the dose-response study 

became ill after infection. Also, since 

the proposal, Griffin et al. (2002) 

analyzed previous outbreaks and 

identified one rotavirus genotype that is 

associated with outbreaks involving 

adults in the U.S. This new knowledge 

suggests that the morbidity value for 

adults can be much more variable than 

previously believed depending on 

which rotavirus genotype is consumed. 

EPA now uses a range in the rotavirus 

adult morbidity value from 0.10–0.50 

and a uniform distribution. The 

distribution selected reflects the 

variability among rotavirus genotypes. 

EPA obtained additional echovirus 

(Type B) morbidity data to improve the 

analysis described in the proposal. The 

proposal used only Echovirus type 30 

morbidity data from the Seattle Virus 

Watch Study (Hall et al., 1970) based on 

the assumption that data from a single 

strain would minimize variability 

among the general population. In this 

rule, EPA uses multiple echovirus 

serotype data from both the Seattle and 

New York Virus Watch Studies (Kogon 

et al., 1969) to determine the range of 


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morbidity rates in the general 

population. 

c. Are the benefits and the data used 

to estimate the benefits of the GWR 

sufficient to justify regulatory action? 

EPA received several comments that 

addressed the calculation of benefits. 

Most commenters questioned whether 

the GWR benefits are sufficient to justify 

regulatory action. In particular, 

comments suggested that the probability 

of an outbreak is low and there is no 

linkage between undisinfected ground 

water and waterborne disease. EPA also 

received several comments about the 

overall lack of information suitable for 

estimating health benefits. 

In general, EPA recognizes that the 

health effects data available for use in 

calculating GWR benefits are limited 

because there are no national 

epidemiological studies to identify 

waterborne disease from ground water 

nor is there any national system for 

reporting waterborne disease once it is 

identified. 

EPA has substantially revised its 

benefits analysis to use a combination of 

measured data, calculated values, and 

reasonable assumptions to make 

predictions about benefits. The benefits 

determined for the GWR are based on 

measurement of pathogenic enteric 

viruses in public drinking water wells, 

so these data are directly applicable to 

making predictions about possible 

avoided illnesses due to elimination of 

these pathogens from the drinking water 

supply. Furthermore, it should be 

recognized that, in the benefits 

calculation, EPA does not assume that 

pathogen occurrence automatically 

results in illness in all individuals 

consuming water from that drinking 

water supply well. EPA used doseresponse data from human feeding 

studies to determine the probability that 

an individual would become infected by 

consuming water with a range of 

pathogen concentrations. For echovirus 

(one of the enteroviruses), illness rates 

and ranges were determined from 

epidemiology studies on the general 

population. For rotavirus, illness rates 

and ranges were determined from 

epidemiology studies on the general 

population and from the symptomatic 

response to infection in human 

challenge studies. 

d. Transparency of regulatory impact 

analysis. Some commenters expressed 

that the Regulatory Impact Analysis for 

the proposed GWR (USEPA, 2000f) did 

not provide a clear description of the 

critical assumptions underlying the cost 

and benefit analysis. 

EPA believes that it has made the 

GWR EA for the final rule more 

transparent than the analysis done for 

the proposal. Changes include (1) 

Expanded text on the basis for most of 

the assumptions used in the analysis, (2) 

expanded text and new diagrams 

describing how the different steps in the 

analysis are combined to produce an 

aggregate analysis, and (3) expanded 

text on how the nonquantified benefits 

complement the quantified benefits 

analysis. 

3. Risk Management 

a. What is EPA’s response to 

comments that EPA chose the wrong 

option and that the benefits do not 

justify the cost or that the rule is not 

cost-effective? Consistent with EPA’s 

statutory requirements, the Agency 

carefully considered benefits and costs 

in proposing and promulgating the 

GWR. The Agency’s decision for the 

final rule is described in VII.A. The 

Agency believes that this rule provides 

benefits at a cost that is justified. In 

making decisions for the final rule, EPA 

considered both quantified and 

nonquantified benefits and costs as well 

as the other components of the Health 

Risk Reduction and Cost Analysis 

(HRRCA) outlined in section 

1412(b)(3)(C) of the SDWA. 

In the proposal, the Multi-Barrier 

approach (Regulatory Alternative 3) had 

net benefits similar to the proposed 

regulatory Alternative 2, Sanitary 

Survey and Triggered Monitoring. 

However, the Multi-Barrier approach 

provided a greater reduction in illnesses 

and deaths, especially to children. After 

an exhaustive review of the benefits and 

cost estimates used in the proposal 

resulting from public comments, peer 

review, and the NDWAC Arsenic 

Review panel, the Agency updated both 

the benefit and cost analysis for each 

rule option. The risk-targeted approach, 

which was selected for the final rule, 

has lower net benefits than Alternative 

1, but more than Alternatives 3 and 4. 

EPA believes that the additional benefits 

realized under Alternative 2 justify its 

selection over Alternative 1, despite the 

lower net benefits. 

Other commenters noted that the 

proposed rule is not cost-effective. The 

mean cost per viral illness avoided for 

the final rule ranges from $1,476 to 

$1,488, at three percent and seven 

percent discount rates respectively. 

These represent the lowest values of all 

alternatives considered and are much 

lower than either Alternative 1 or 

Alternative 4. Thus, Alternative 2 is the 

most cost-effective rule alternative by 

this measure. 

b. Did the Agency consider that some 

systems may have negative net benefits, 

and did the Agency conduct an 

incremental analysis by system size and 

type? Some commenters noted that the 

costs may exceed benefits for smaller 

size systems. EPA agrees that for some 

drinking water regulations the costs may 

exceed the benefits because the 

populations served by these systems are 

much smaller. Generally, large systems 

benefit from economies of scale which 

eases the relative impact on these 

systems. In addition, many GWR 

benefits remain nonquantified. 

Other commenters suggested that EPA 

should exclude or set different 

standards for small systems based on 

benefit and cost analysis, including 

incremental analysis, by system size or 

type. However, the SDWA does not 

generally provide a basis for 

establishing tailored drinking water 

standards as these commenters suggest. 

Rather, the SDWA is designed to ensure 

uniform levels of public health 

protection across the country (except as 

specifically provided for in variances 

from the standard). 

Thus EPA disagrees with the 

suggestion that the level of the final 

standard be altered to address system 

size or type. However, as discussed in 

detail in the preamble of this rule, the 

rule provides flexibility that reduces 

burden on small systems and reflects 

individual system conditions. Financial 

and technical assistance is also available 

through various funding authorities. 

Regarding affordability, variances based 

on affordability are not allowed by the 

SDWA for regulations addressing 

microbial contamination, and as a result 

EPA did not conduct an affordability 

analysis. However, EPA has considered 

the SAB review of the Arsenic Rule and 

the suggestions of the NDWAC Arsenic 

Cost Working Group regarding the 

further disaggregation of the analyses. 

The NDWAC group recommended 

calculation and presentation of cost 

information in multiple size categories, 

which is done in the GWR EA (USEPA, 

2006d). 

In addition, the Agency took many 

steps to reduce the burden on small 

systems where possible. More 

information regarding this effort can be 

found in Chapter 6 of the GWR EA 

(USEPA, 2006d). 

VIII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

Under Executive Order (EO) 12866 

(58 FR 51735, October 4, 1993), this 

action is a ‘‘significant regulatory 

action’’. Accordingly, EPA submitted 

this action to the Office of Management 

and Budget (OMB) for review under EO 

12866 and any changes made in 


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response to OMB recommendations 

have been documented in the docket for 

this action. 

In addition, EPA has prepared an 

analysis of the potential costs and 

benefits associated with this action. 

This analysis is contained in the 

Economic Analysis for the Final Ground 

Water Rule (USEPA, 2006d). A copy of 

the analysis is available in the docket 

for this action and the analysis is briefly 

summarized in Section VII of this 

preamble. 

B. Paperwork Reduction Act 

The Office of Management and Budget 

(OMB) has approved the information 

collection requirements contained in 

this rule under the provisions of the 

Paperwork Reduction Act, 44 U.S.C. 

3501 et seq. and has assigned OMB 

control number 2040–0271. 

The information collected as a result 

of this rule will allow the States and 

EPA to make decisions and evaluate 

compliance with the rule. For the first 

three years after the promulgation of the 

GWR, the major information 

requirements are for States and PWSs to 

prepare for implementation of the rule. 

The information collection requirements 

are described in 40 CFR part 141, for 

systems, and part 142, for States, and 

are mandatory. The information 

collected is not confidential. 

EPA estimates that the annual burden 

on PWSs and States for reporting and 

recordkeeping will be 385,264 hours. 

This annual burden is based on an 

estimate that 57 States and territories 

will each need to provide one response 

each year with an average of 2,193 hours 

per response, and that 49,110 systems 

will each provide two responses each 

year with an average of 2.6 hours per 

response. The total reporting and 

recordkeeping cost over the three-year 

period of the Information Collection 

Request is $30,274,266 (labor costs) 

(USEPA, 2006a). It should be noted, 

however, that much of the paperwork 

burden of the rule will be incurred only 

after the three-year time horizon 

covered in this analysis. Subsequent ICR 

submissions will address future burden 

for activities such as triggered and 

compliance monitoring. There are no 

operation, maintenance or capital costs 

estimated for the first three years. The 

labor burden is estimated for the 

following activities: reading and 

understanding the rule, planning, 

training, and meeting primacy 

requirements. Burden means the total 

time, effort, or financial resources 

expended by persons to generate, 

maintain, retain, or disclose or provide 

information to or for a Federal agency. 

This includes the time needed to review 

instructions; develop, acquire, install, 

and utilize technology and systems for 

the purposes of collecting, validating, 

and verifying information, processing 

and maintaining information, and 

disclosing and providing information; 

adjust the existing ways to comply with 

any previously applicable instructions 

and requirements; train personnel to be 

able to respond to a collection of 

information; search data sources; 

complete and review the collection of 

information; and transmit or otherwise 

disclose the information. 

An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in 40 

CFR are listed in 40 CFR part 9. In 

addition, EPA is amending the table in 

40 CFR part 9 of currently approved 

OMB control numbers for various 

regulations to list the regulatory 

citations for the information 

requirements contained in this rule. 

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 substantial 

number of small entities. Small entities 

include small businesses, small 

organizations, and small governmental 

jurisdictions. 

The RFA provides default definitions 

for each type of small entity. Small 

entities are defined as: (1) A small 

business as defined by the Small 

Business Administration’s (SBA) 

regulations at 13 CFR 121.201; (2) a 

small governmental jurisdiction that is a 

government of a city, county, town, 

school district or special district with a 

population of less than 50,000; and (3) 

a small organization that is any ‘‘not-forprofit enterprise which is independently 

owned and operated and is not 

dominant in its field.’’ However, the 

RFA also authorizes an agency to use 

alternative definitions for each category 

of small entity, ‘‘which are appropriate 

to the activities of the agency’’ after 

proposing the alternative definition(s) in 

the Federal Register and taking 

comment. 5 U.S.C. 601(3)–(5). In 

addition, to establish an alternative 

small business definition, agencies must 

consult with SBA’s Chief Counsel for 

Advocacy. 

For purposes of assessing the impacts 

of the final GWR on small entities, EPA 

considered defining ‘‘small entities’’ in 

its regulatory flexibility assessments 

under the RFA to be public water 

systems serving 10,000 or fewer 

persons. As required by the RFA, EPA 

proposed using this alternative 

definition in the Federal Register (63 FR 

7620, February 13, 1998), requested 

public comment, consulted with the 

Small Business Administration (SBA), 

and finalized the alternative definition 

in the Consumer Confidence Reports 

regulation (63 FR 44511, August 19, 

1998). As stated in that Final Rule, the 

alternative definition applies to this 

regulation as well. 

Pursuant to section 603 of the RFA, 

EPA prepared an initial regulatory 

flexibility analysis (IRFA) for the 

proposed rule (see 65 FR 30193, May 10, 

2000) and convened a Small Business 

Advocacy Review Panel to obtain advice 

and recommendations of representatives 

of the regulated small entities (USEPA, 

2000a). A detailed discussion of the 

Panel’s advice and recommendations is 

found in the Panel Report (docket 

number EPA–HQ–OW–2002–0061; 

document number W–98–23–I.E–2). A 

summary of the Panel’s 

recommendations is presented in the 

GWR proposal at 65 FR 30253, May 10, 

2000 (USEPA, 2000a). 

As required by section 604 of the 

RFA, we also prepared a final regulatory 

flexibility analysis (FRFA) for the final 

GWR. The FRFA addresses the issues 

raised by public comments on the IRFA, 

which was part of the proposal of this 

rule. The FRFA is available for review 

in the docket and is summarized below. 

EPA is issuing this final rule to 

comply with section 1412(b)(8) of the 

SDWA, which directs EPA to 

‘‘promulgate national primary drinking 

water regulations requiring disinfection 

as a treatment technique for all public 

water systems, including surface water 

systems and, as necessary, ground water 

systems.’’ The need for this final rule is 

based upon the substantial likelihood 

that fecal contamination of ground 

water supplies is occurring at 

frequencies and levels that present 

public health concern. Fecal 

contamination refers to the 

contaminants, particularly the 

microorganisms, contained in human or 

animal feces. These microorganisms 

may include bacterial and viral 

pathogens, which can cause illnesses in 

the individuals that consume them. The 

objective of the final GWR is to identify 

those systems with fecal contamination 

and undertake corrective action to 

eliminate or address that contamination. 

Two significant issues were raised in 

comments on the IRFA for the proposed 

rule. First, several commenters wrote 


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that small water systems lack the 

customer base to defray the costs of 

installing new treatment, such as 

disinfection, or the cost of a new source. 

EPA notes that the final GWR does not 

mandate disinfection, but rather is a 

flexible regulation, targeting those highrisk systems or sources that are 

vulnerable to contamination. EPA also 

notes that financial assistance is 

available to small systems through 

programs such as the Drinking Water 

State Revolving Fund, the Loan and 

Grant program of the U.S. Department of 

Agriculture’s Rural Utilities Services 

(RUS) and the Community Development 

Block Grant Program of the Department 

of Housing. The second significant issue 

raised in comments on the IRFA was a 

recommendation that EPA allow the 

States flexibility to consider competing 

fiscal impacts on small systems when 

implementing the rule. EPA believes the 

final rule has greater flexibility and is 

less burdensome for States and small 

systems than the proposal. For example, 

a GWS serving 1,000 people or fewer 

may use a repeat sample collected from 

a ground water source to meet the TCR 

to satisfy the GWR triggered source 

water monitoring requirements if the 

State approves the use of E. coli as a 

fecal indicator for ground water source 

monitoring. 

EPA assessed the potential impact of 

the final GWR on small entities. There 

are 147,330 CWSs, NTNCWSs, and 

TNCWSs providing potable ground 

water to the public; 145,580 (99 percent) 

are classified by EPA as small entities. 

EPA has determined that all small 

systems are impacted by the sanitary 

survey requirement and a substantial 

number these systems will be impacted 

by additional requirements of the final 

GWR, including the triggered source 

water monitoring requirements and the 

corrective action requirements. 

In addition, in the final GWR there are 

a number of recordkeeping and 

reporting requirements for all GWSs 

(including small systems). To minimize 

the burden with these provisions, the 

final rule uses a risk-based regulatory 

strategy, whereby the monitoring 

requirements are based on system 

characteristics and not directly related 

to system size. In this manner, the rule 

takes a system-specific approach to 

regulation. 

To prevent conflict and overlap with 

other Federal rules, this final rule 

leverages the existing TCR monitoring 

framework to the extent possible (e.g., 

by using the results of the routine TCR 

monitoring to determine if source water 

monitoring is required). GWSs that do 

not reliably treat to 4-log inactivation or 

removal of viruses are required to 

collect a source water sample following 

a total coliform-positive sample in the 

distribution system. Additionally, 

systems may utilize one of the followup monitoring samples required under 

the TCR to meet the triggered source 

water sampling requirements of this 

final rule. 

As a result of the input received from 

stakeholders, the EPA workgroup, and 

other interested parties, EPA 

constructed four regulatory options: The 

sanitary survey option, the sanitary 

survey and triggered monitoring option, 

the multi-barrier option, and the acrossthe-board disinfection option. In 

developing this final rule, EPA 

considered the recommendations to 

minimize the cost impact to small 

systems. A risk-targeted approach, based 

on sanitary surveys and triggered source 

water monitoring (which only requires 

corrective action if the GWS has a 

sanitary survey significant deficiency or 

source water fecal contamination), was 

selected as the option to protect public 

health and to reduce burden. 

Assessment source water monitoring, 

part of the preferred proposal option 

(the multi-barrier option), has been 

finalized as a discretionary requirement 

as determined by the State, allowing 

further flexibility and burden reduction. 

To mitigate the associated compliance 

cost increases across water systems, this 

final rule also provides States with 

considerable flexibility when 

implementing other requirements of the 

rule. This flexibility will allow States to 

consider the characteristics of 

individual systems when determining 

an appropriate corrective action. For 

example, States have the flexibility to 

allow systems to fix existing wells, drill 

a new well, obtain a new source, or use 

any disinfection treatment technology 

that achieves 4-log inactivation or 

removal of viruses. States may also 

determine that the source of 

contamination has been eliminated if, 

after thorough investigation by the State 

and the system, the State concludes that 

contamination is unlikely to reoccur. 

As required by section 212 of the 

Small Business Regulatory Enforcement 

Fairness Act (SBREFA), EPA also is 

preparing a Small Entity Compliance 

Guide to help small entities comply 

with this rule. This guide will be 

available on EPA’s Web site at http:// 

www.epa.gov/safewater/disinfection/ 

gwr/index.html or by calling the Safe 

Drinking Water Hotline at (800) 426–

4791. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA), Pub. L. 

104–4, establishes requirements for 

Federal agencies to assess the effects of 

their regulatory actions on State, local, 

and Tribal governments and the private 

sector. Under section 202 of UMRA, 

EPA generally must prepare a written 

statement, including a cost-benefit 

analysis, for proposed and final rules 

with ‘‘Federal mandates’’ that may 

result in expenditures to State, local, 

and Tribal governments, in the 

aggregate, or to the private sector, of 

$100 million or more in any one year. 

Before promulgating an EPA rule for 

which a written statement is needed, 

section 205 of the UMRA generally 

requires EPA to identify and consider a 

reasonable number of regulatory 

alternatives and adopt the least costly, 

most cost-effective or least burdensome 

alternative that achieves the objectives 

of the rule. The provisions of section 

205 do not apply when they are 

inconsistent with applicable law. 

Moreover, section 205 allows EPA to 

adopt an alternative other than the least 

costly, most cost-effective or least 

burdensome alternative if the 

Administrator publishes with the final 

rule an explanation why that alternative 

was not adopted. Before EPA establishes 

any regulatory requirements that may 

significantly or uniquely affect small 

governments, including Tribal 

governments, it must have developed 

under section 203 of the UMRA a small 

government agency plan. The plan must 

provide for notifying potentially 

affected small governments, enabling 

officials of affected small governments 

to have meaningful and timely input in 

the development of EPA regulatory 

proposals with significant Federal 

intergovernmental mandates, and 

informing, educating, and advising 

small governments on compliance with 

the regulatory requirements. 

EPA has determined that this rule 

does not contain a Federal mandate that 

may result in expenditures of $100 

million or more for State, local, or Tribal 

governments in the aggregate, or the 

private sector in any one year (see Table 

VIII–1). The rule is estimated to cost 

State, local and Tribal governments 

$41.5 to $41.9 million. Public water 

systems that are privately owned will 

incur total costs of $20.3 to $20.4 

million per year. A more detailed 

description is presented in the 

Economic Analysis for the Final Ground 

Water Rule (USEPA, 2006d), which is 

available in the water docket. Thus, this 

rule is not subject to the requirements 

of sections 202 and 205 of the UMRA. 


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In developing this rule, EPA 

consulted with small governments 

pursuant to its interim plan established 

under section 203 of the UMRA to 

address impacts of regulatory 

requirements in the rule that might 

significantly or uniquely affect small 

governments. EPA held four public 

meetings for all stakeholders. Because of 

the GWR’s impact on small entities, the 

Agency convened a Small Business 

Advocacy Review (SBAR) Panel in 

accordance with the Regulatory 

Flexibility Act (RFA) as amended by the 

Small Business Regulatory Enforcement 

Fairness Act (SBREFA) to address small 

entity concerns, including small local 

governments specifically. EPA 

consulted with small entity 

representatives prior to convening the 

Panel to get their input on the GWR. Of 

the 22 small entity participants, five 

represented small governments. EPA 

also made presentations on the GWR to 

the national and some local chapters of 

the American Water Works Association, 

the Ground Water Foundation, the 

National Ground Water Association, the 

National Rural Water Association, and 

the National League of Cities. 

E. Executive Order 13132: Federalism 

Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999), requires EPA to develop an 

accountable process to ensure 

‘‘meaningful and timely input by State 

and local officials in the development of 

regulatory policies that have federalism 

implications.’’ ‘‘Policies that have 

federalism implications’’ is defined in 

the Executive Order to include 

regulations that have ‘‘substantial direct 

effects on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’

This final rule does not have 

Federalism implications. It will not 

have substantial direct effects on the 

States, on the relationship between the 

national government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132. This rule does 

not contain a ‘‘significant Federal 

government mandate’’ under section 

202 of the UMRA, nor does it have a 

significant impact on small 

governments. Thus, Executive Order 

13132 does not apply to this rule. 

Although Section 6 of Executive 

Order 13132 does not apply to this rule, 

EPA did consult with State and local 

officials in developing this rule (65 FR 

30203 and 30263, May 10, 2000) 

(USEPA, 2000a). A summary of the 

concerns raised during that consultation 

and EPA’s response to those concerns 

are provided in the proposal. In the 

spirit of Executive Order 13132, and 

consistent with EPA policy to promote 

communications between EPA and State 

and local governments, EPA specifically 

solicited comment on the proposed rule 

from State and local officials. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

Executive Order 13175, entitled 

‘‘Consultation and Coordination with 

Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), requires EPA 

to develop ‘‘an accountable process to 

ensure meaningful and timely input by 

tribal officials in the development of 

regulatory policies that have tribal 

implications.’’ Under Executive Order 

13175, EPA may not issue a regulation 

that has Tribal implications, that 

imposes substantial direct compliance 

costs, and that is not required by statute, 

unless the Federal government provides 

the funds necessary to pay the direct 

compliance costs incurred by Tribal 

governments, or EPA consults with 

Tribal officials early in the process of 

developing the proposed regulation and 

develops a Tribal summary impact 

statement. 

EPA has concluded that this final rule 

may have Tribal implications because it 

may impose substantial direct 

compliance costs on Tribal governments 

and the Federal government will not 

provide the funds necessary to pay 

those costs. This rule will significantly 

affect communities of Tribal 

governments because 87 percent of 

PWSs in Indian Country are GWSs. 

Accordingly, EPA provides the 

following Tribal summary impact 

statement as required by section 5(b). 

EPA consulted with Tribal officials 

early in the process of developing this 

regulation to permit them to have 

meaningful and timely input into its 

development (see the proposed rule, 65 

FR 30259, May 10, 2000) (USEPA, 

2000a). Two consultations took place at 

national conferences; one for the 

National Indian Health Board and the 

other for the National Tribal 

Environmental Council. A third 

consultation was conducted in 

conjunction with the Inter-Tribal 

Council of Arizona, Inc. EPA received 

one comment on the proposed rule from 

a Tribal organization. The organization 

is concerned that the GWR will have a 

negative impact on their ability to 

provide infrastructure improvements by 

taking funding resources away from new 

water supply construction programs and 

applying these funds to cover 

compliance costs for existing water 

systems. EPA recognizes that the GWR 

will increase the compliance burden for 

some Tribal PWSs, however, EPA 

believes that the GWR will provide 

public health benefits that justify the 

increase in burden. To offset some of 

this burden, EPA has provided 

flexibility for small systems through 

various mechanisms. For a detailed 

discussion, please see Section IV of this 

preamble. 


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As required by section 7(a), EPA’s 

Tribal Consultation Official has certified 

that the requirements of this Executive 

Order have been met in a meaningful 

and timely manner. A copy of the 

certification is included in the docket 

for this rule. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

Executive Order 13045: ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997) applies to any rule that: 

(1) Is determined to be ‘‘economically 

significant’’ as defined under Executive 

Order 12866, and (2) concerns an 

environmental health or safety risk that 

EPA has reason to believe may have a 

disproportionate effect on children. If 

the regulatory action meets both criteria, 

the Agency must evaluate the 

environmental health or safety effects of 

the planned rule on children, and 

explain why the planned regulation is 

preferable to other potentially effective 

and reasonably feasible alternatives 

considered by the Agency. 

While this final rule is not subject to 

the Executive Order because it is not 

economically significant as defined 

under Executive Order 12866, we 

nonetheless have reason to believe that 

the environmental health or safety risk 

addressed by this action may have a 

disproportionate effect on children. As 

a matter of EPA policy, we therefore 

assessed the environmental health or 

safety effects of viruses on children. The 

results of this assessment are contained 

in Section VII.I.1 of the preamble of this 

rulemaking as well as in the final GWR 

EA (USEPA, 2006d). 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This rule is not a ‘‘significant energy 

action’’ as defined in Executive Order 

13211, ‘‘Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355 (May 

22, 2001)) because it is not likely to 

have a significant adverse effect on the 

supply, distribution, or use of energy. 

1. Energy Supply 

The GWR does not regulate power 

generation, either directly or indirectly. 

The public and private PWSs that the 

GWR regulates do not, in general, 

generate power. Further, the cost 

increases borne by customers of PWSs 

as a result of the GWR represent a small 

percentage of the total cost of water, 

except for a very few small systems that 

will need to spread the cost of installing 

advanced technologies over a narrow 

customer base. Therefore, the customers 

that are power generation utilities are 

unlikely to face any significant effects as 

a result of the GWR. In summary, the 

GWR does not regulate the supply of 

energy, does not generally regulate the 

utilities that supply energy, and is 

unlikely to significantly affect the 

customer base of energy suppliers. 

Thus, the GWR will not adversely affect 

the supply of energy. 

2. Energy Distribution 

The GWR does not regulate any aspect 

of energy distribution. PWSs that are 

regulated by the GWR already have 

electrical service. The rule is projected 

to increase peak electricity demand at 

PWSs by only 0.001 percent (see below). 

Therefore, EPA assumes that the 

existing connections are adequate and 

that the GWR has no discernable 

adverse effect on energy distribution. 

3. Energy Use 

Some PWSs are expected to add 

treatment technologies that use 

electrical power. This potential impact 

of the GWR on the use of energy was 

evaluated. The analyses that underlay 

the estimation of costs are national in 

scope and do not identify specific plants 

or systems that may install treatment in 

response to the GWR. As a result, no 

analysis of the effect on specific energy 

suppliers is possible with the available 

data. Further data are required to 

evaluate the effect on specific energy 

suppliers. The approach used to 

estimate the impact of energy use, 

therefore, focuses on national-level 

impacts. In this approach, EPA 

estimates the additional energy use due 

to the GWR and compares that to the 

national levels of power generation in 

terms of average and peak loads. 

The first step is to estimate the energy 

used by the technologies or corrective 

action expected to be installed as a 

result of the GWR. Energy use is not 

directly estimated in the Technology 

and Cost Document for the Final 

Ground Water Rule (USEPA, 2006h), but 

the annual cost of energy for each 

technology and corrective action 

addition or upgrade necessitated by the 

GWR is provided. An estimate of plantlevel energy use is derived by dividing 

the total energy cost per plant for a 

range of flows by an average national 

cost of electricity of $0.076 per kilowatt 

hour per year (kWh/y) (USDOE EIA, 

2002). The energy use per plant for each 

flow range and technology or corrective 

action is then multiplied by the number 

of plants predicted to install each 

technology in a given flow range. The 

energy requirements for each flow range 

are then added to produce a national 

total. No electricity use is subtracted to 

account for the technologies that may be 

replaced by new technologies, resulting 

in a conservative estimate of the 

increase in energy use. An incremental 

national annual energy usage of 4,521 

megawatt hours (mWh) was calculated. 

The total increase in energy usage by 

water systems as a result of the GWR is 

predicted to be approximately 4.5 

million kWh/y, which is less than oneten-thousandth of one percent of the 

total energy produced in 2003. While 

the rule may have some adverse energy 

effects, EPA does not believe that this 

constitutes a significant adverse effect 

on the energy supply. See the Economic 

Analysis for the Final Ground Water 

Rule (USEPA, 2006d) for further detail. 

I. National Technology Transfer and 

Advancement Act 

As noted in the proposed rule, 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (‘‘NTTAA’’), Public Law 

104–113, 12(d) (15 U.S.C. 272 note) 

directs EPA to use voluntary consensus 

standards in its regulatory activities 

unless to do so would be inconsistent 

with applicable law or otherwise 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures, and business 

practices) that are developed or adopted 

by voluntary consensus standards 

bodies. The NTTAA directs EPA to 

provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. 

This rulemaking involves technical 

standards. EPA has identified some 

consensus standards and developed or 

modified methods for the remaining 

methods requirements. These methods 

are listed in § 141.402(c). 

Most of the methods that EPA is 

approving for the detection of E. coli in 

source waters are consensus methods 

described in Standard Methods for the 

Examination of Water and Wastewater 

(20th Edition) (APHA, 1998). The three 

E. coli methods that are not consensus 

methods are newly developed: MI agar 

(a membrane filter method), the 

ColiBlue 24 test (a membrane filter 

method) and the E*Colite test (a defined 

dehydrated medium to which water is 

added). EPA has already evaluated and 

approved these three methods for use 

under the TCR. Of the three enterococci 

methods EPA is approving in this rule, 

two are consensus methods in Standard 

Methods; the third (Enterolert) was 

described in a peer-reviewed journal 

article (Budnick et al., 1996). 


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The two methods EPA proposed for 

the detection of coliphage in source 

water are not consensus methods. For 

the coliphage tests, EPA is approving 

the use of two methods: EPA Method 

1601 (Two-Step Enrichment PresenceAbsence Procedure) (USEPA, 2001a) 

and EPA Method 1602 (Single Agar 

Layer Procedure) (USEPA, 2001b). EPA 

Method 1601 is a new method 

optimized for the detection of a single 

coliphage in a small (100–1,000 mL) 

water sample. EPA did not use the 

consensus method for coliphage in 

Standards Methods (20th edition) 

(Method 9211D) (APHA, 1998) rather, 

EPA modified and optimized Method 

9211D to improve its sensitivity and 

versatility. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order 12898 establishes a 

Federal policy for incorporating 

environmental justice into Federal 

Agency missions by directing agencies 

to identify and address 

disproportionately high and adverse 

human health or environmental effects 

of its programs, policies, and activities 

on minority and low-income 

populations. 

The Environmental Justice Executive 

Order requires the Agency to consider 

environmental justice issues in the 

rulemaking and to consult with 

minority and low-income stakeholders. 

The Agency has considered 

environmental justice issues concerning 

the potential impacts of this action and 

has consulted with minority and lowincome stakeholders. The GWR applies 

to all PWSs (CWSs, NTNCWSs, and 

NTCWSs) that use ground water as their 

source water. Consequently, the health 

protection benefits provided by this rule 

are equal across all income and minority 

groups served by these systems. Existing 

regulations such as the SWTR, IESWTR, 

and LT2ESWTR provide similar health 

benefit protection to communities that 

use surface water or ground water under 

the direct influence of surface water. 

Nonetheless, the Agency held a 

stakeholder meeting on March 12, 1998, 

to address various components of 

pending drinking water regulations and 

how they may impact sensitive subpopulations, minority populations, and 

low-income populations. See the 

discussion of this meeting in the 

proposed rule for further information 

(65 FR 30261, May 10, 2000) (USEPA, 

2000a). 

K. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is a ‘‘major rule’’ as defined 

by 5 U.S.C. 804(2). This rule will be 

effective January 8, 2007. 

L. Analysis of the Likely Effect of 

Compliance With the GWR on the 

Technical, Financial, and Managerial 

Capacity of Public Water Systems 

Section 1420(d)(3) of SDWA, as 

amended, requires that in promulgating 

an NPDWR, the Administrator shall 

include an analysis of the likely effect 

of compliance with the regulation on 

the technical, managerial, and financial 

capacity of public water systems. This 

analysis can be found in the GWR 

Economic Analysis (USEPA, 2006d). 

Analyses reflect only the impact of new 

requirements, as established by the 

GWR; the impacts of previously 

established requirements on system 

capacity are not considered. 

IX. Consultation With Science Advisory 

Board, National Drinking Water 

Advisory Council, and the Secretary of 

Health and Human Services; and Peer 

Review 

In accordance with sections 1412(d) 

and 1412(e) of the SDWA, the Agency 

consulted with the Science Advisory 

Board, the National Drinking Water 

Advisory Council (NDWAC), and the 

Secretary of Health and Human 

Services. 

In addition, this rule was supported 

by influential scientific information. 

Therefore, the Agency conducted a peer 

review in accordance with OMB’s Final 

Information Quality Bulletin for Peer 

Review (OMB, December 15, 2004). EPA 

developed charge questions related to 

the statistical approach used to 

characterize national occurrence of viral 

pathogens and fecal indicators; risk 

characterization including doseresponse modeling; characterization of 

morbidity, mortality, and severity for 

Type A and Type B viruses; 

characterization of nonquantified 

benefits; and national risk reduction 

(benefits) and costs for the GWR. The 

Peer Review Report is located in the 

docket for this rule. 

X. References 

Abbaszadegan, M., M. LeChevallier, and C. 

Gerba. 2003. Occurrence of viruses in 

U.S. groundwaters. Journal AWWA. 

95(9):107–120. 

Abbaszadegan, M. 2002. Viruses in drinking 

water and groundwater. p. 3288–3300. In 

G. Bitton (ed.), Encyclopedia of 

Environmental Microbiology. John Wiley 

& Sons, Inc., New York. ISBN 0–471–

35450–3. 

Abbaszadegan, M., P.W. Stewart, M.W. 

LeChevallier, J.S. Rosen, and C.P. Gerba. 

1999a. Occurrence of Viruses in Ground 

Water in the United States. American 

Water Works Association Research 

Foundation. Denver, CO, 189 pp. 

Abbaszadegan, M., P.W. Stewart, and M.W. 

LeChevallier. 1999b. A strategy for 

detection of viruses in groundwater by 

PCR. Applied and Environmental 

Microbiology. 65(2):444–449. 

Abbaszadegan, M., M. Denhart, M. Spinner, 

G. Di Giovanni, and M. LeChavallier. 

1999c. Identification of viruses present 

in ground water cell culture harvest by 

PCR. In: Proceedings, Water Quality 

Technology Conference. American Water 

Works Association, Denver, CO. 

Anderson, A.D., A.G. Heryford, J.P. Sarisky, 

C. Higgins, S.S. Monroe, R.S. Beard, C.M. 

Newport, J.L. Cashdollar, G.S. Fout, D.E. 

Robbins, S.A. Seys, K.J. Musgrave, C. 

Medus, Jan Vinje, J.S. Bresee, H.M. 

Mainzer, and R.I. Glass. 2003. A 

waterborne outbreak of Norwalk-like 

virus among snowmobilers-Wyoming, 

2001. Jour. Infect. Diseases. 187:303–306. 

Angulo, F.J., S. Tippen, D. Sharp, B.J. Payne, 

C. Collier, J. Hill, T.J. Barrett, R.M. Clark, 

E. Geldreich, H.D. Donnell, and D.L. 

Swerdlow. 1997. A community 

waterborne outbreak of Salmonellosis 

and the effectiveness of a boil water 

order. Am. J. Public Health. 87(4):580–

584. 

APHA. (American Public Health 

Association). 1998. Standard Methods 

for the Examination of Water and 

Wastewater (20th ed.). 1015 Fifteenth 

Street, NW., Washington, DC 20005. 

ASDWA (Association of State Drinking Water 

Administrators). 1998. Results and 

Analysis of ASDWA Survey of BMPs in 

Community Ground Water Systems. 

April 1998. 

ASDWA (Association of State Drinking Water 

Administrators). 1997. Survey of Best 

Management Practices for Community 

Ground Water Systems. ASDWA: 

Washington DC, December. 

Atherholt, T., E. Feerst, B. Hovendon, J. 

Kwak, and D. Rosen. 2003. Evaluation of 

indicators of fecal contamination in 

groundwater. Journal of the American 

Water Works Association. 95(10):119–

131. 

Banks, W.S.L. and D.A. Battigelli. 2002. 

Occurrence and distribution of 

microbiological contamination and 


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enteric viruses in shallow ground water 

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List of Subjects 

40 CFR Part 9 

Reporting and recordkeeping 

requirements. 

40 CFR Part 141 

Environmental protection, Chemicals, 

Indians-lands, Incorporation by 

reference, Intergovernmental relations, 

Radiation protection, Reporting and 

recordkeeping requirements, Water 

supply. 

40 CFR Part 142 

Environmental protection, 

Administrative practice and procedure, 

Chemicals, Indians-lands, Radiation 

protection, Reporting and recordkeeping 

requirements, Water supply. 

Dated: October 11, 2006. 

Stephen L. Johnson, 

Administrator. 

For the reasons set forth in the 

preamble, title 40 chapter I of the Code 

of Federal Regulations is amended as 

follows: 


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PART 9—OMB APPROVALS UNDER 

THE PAPERWORK REDUCTION ACT 

■ 1. The authority citation for part 9 

continues to read as follows: 

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; Executive Order 11735, 38 FR 

21243, 3 CFR, 1971–1975 Comp. p. 973; 42 

U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g–

1, 300g–2, 300g–3, 300g–4, 300g–5, 300g–6, 

300j–1, 300j–2, 300j–3, 300j–4, 300j–9, 1857 

et seq., 6901–6992k, 7401–7671q, 7542, 

9601–9657, 11023, 11048. 

■ 2. In § 9.1 the table is amended by 

adding entries § 141.401–141.405’’, 

§ 142.14(d)(17)’’, § 142.15(c)(7)’’ and 

§ 142.16(o)’’ in numerical order, as 

follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB control 

No. 

* * * * * * * 

National Primary Drinking Water Regulations 

* * * * * * * 

141.401–141.405 ................................................................................................................................................................................. 2040–0271 

* * * * * * * 

National Primary Drinking Water Regulations Implementation 

* * * * * * * 

142.14(d)(17) ....................................................................................................................................................................................... 2040–0271 

* * * * * * * 

142.15(c)(7) ......................................................................................................................................................................................... 2040–0271 

* * * * * * * 

142.16(o) .............................................................................................................................................................................................. 2040–0271 

* * * * * 

PART 141—NATIONAL PRIMARY 

DRINKING WATER REGULATIONS 

■ 3. 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. 

■ 4. Section 141.21 is amended by 

adding paragraph (d)(3) to read as 

follows: 

§ 141.21 Coliform sampling. 

* * * * * 

(d) * * * 

(3) Sanitary surveys conducted by the 

State under the provisions of 

§ 142.16(o)(2) of this chapter may be 

used to meet the sanitary survey 

requirements of this section. 

* * * * * 

■ 5. Section 141.28 is amended by 

revising paragraph (a) to read as follows: 

§ 141.28 Certified laboratories. 

(a) For the purpose of determining 

compliance with § 141.21 through 

141.27, 141.30, 141.40, 141.74, 141.89 

and 141.402, samples may be 

considered only if they have been 

analyzed by a laboratory certified by the 

State except that measurements of 

alkalinity, calcium, conductivity, 

disinfectant residual, orthophosphate, 

pH, silica, temperature and turbidity 

may be performed by any person 

acceptable to the State. 

* * * * * 

■ 6. Section 141.153 is amended by 

adding a new paragraph (h)(6) to read as 

follows: 

§ 141.153 Content of the reports. 

* * * * * 

(h) * * * 

(6) Systems required to comply with 

subpart S. (i) Any ground water system 

that receives notice from the State of a 

significant deficiency or notice from a 

laboratory of a fecal indicator-positive 

ground water source sample that is not 

invalidated by the State under 

§ 141.402(d) must inform its customers 

of any significant deficiency that is 

uncorrected at the time of the next 

report or of any fecal indicator-positive 

ground water source sample in the next 

report. The system must continue to 

inform the public annually until the 

State determines that particular 

significant deficiency is corrected or the 

fecal contamination in the ground water 

source is addressed under § 141.403(a). 

Each report must include the following 

elements. 

(A) The nature of the particular 

significant deficiency or the source of 

the fecal contamination (if the source is 

known) and the date the significant 

deficiency was identified by the State or 

the dates of the fecal indicator-positive 

ground water source samples; 

(B) If the fecal contamination in the 

ground water source has been addressed 

under § 141.403(a) and the date of such 

action; 

(C) For each significant deficiency or 

fecal contamination in the ground water 

source that has not been addressed 

under § 141.403(a), the State-approved 

plan and schedule for correction, 

including interim measures, progress to 

date, and any interim measures 

completed; and 

(D) If the system receives notice of a 

fecal indicator-positive ground water 

source sample that is not invalidated by 

the State under § 141.402(d), the 

potential health effects using the health 

effects language of Appendix A of 

subpart O. 


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(ii) If directed by the State, a system 

with significant deficiencies that have 

been corrected before the next report is 

issued must inform its customers of the 

significant deficiency, how the 

deficiency was corrected, and the date 

of correction under paragraph (h)(6)(i) of 

this section. 

* * * * * 

■ 7. Appendix A to subpart O is 

amended by adding a new entry ‘‘Fecal 

Indicators (enterococci or coliphage)’’ 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, multiply 

by 

MCL in CCR 

units MCLG 

Major sources 

in drinking 

water 

Health effects language 

Microbiological Contaminants: 

* * * * * * * 

Fecal Indicators (enterococci 

or coliphage).

TT ................. ....................... TT ................. N/A ................ Human and 

animal fecal 

waste.

Fecal indicators are microbes whose presence 

indicates that the water 

may be contaminated with 

human or animal wastes. 

Microbes in these wastes 

can cause short-term 

health effects, such as diarrhea, cramps, nausea, 

headaches, or other 

symptoms. They may 

pose a special health risk 

for infants, young children, 

some of the elderly, and 

people with severely compromised immune systems. 

* * * * * * * 

* * * 

TT=Treatment Technique. 

■ 8. Section 141.202 is amended by 

redesignating entry (8) in Table 1 in 

paragraph (a) as entry (9); and adding a 

new paragraph (8) to read as follows: 

§ 141.202 Tier 1 Public Notice—Form, 

manner, and frequency of notice. 

(a) * * * 

Table 1 to § 141.202—Violation 

Categories and Other Situations 

Requiring a Tier 1 Public Notice 

* * * * * 

(8) Detection of E. coli, enterococci, or 

coliphage in source water samples as 

specified in § 141.402(a) and 

§ 141.402(b). 

* * * * * 

■ 9. Section 141.203 is amended by 

adding entry (4) to Table 1 in paragraph 

(a) to read as follows: 

§ 141.203 Tier 2 Public Notice—Form, 

manner, and frequency of notice. 

(a) * * * 

Table 1 to § 141.203—Violation 

Categories and Other Situations 

Requiring a Tier 2 Public Notice 

* * * * * 

(4) Failure to take corrective action or 

failure to maintain at least 4-log 

treatment of viruses (using inactivation, 

removal, or a State-approved 

combination of 4-log virus inactivation 

and removal) before or at the first 

customer under § 141.403(a). 

* * * * * 

■ 10. Appendix A to Subpart Q of Part 

141 is amended to read as follows: 

■ a. Adding I.A.11; 

■ b. Redesignating entry IV.F as entry 

IV.G; and 

■ c. Adding a new entry IV.F in 

alphabetical order: 

APPENDIX A TO SUBPART Q OF PART 141—NPDWR VIOLATIONS AND OTHER SITUATIONS REQUIRING PUBLIC NOTICE 1

Contaminant 

MCL/MRDL/TT violations 2 Monitoring and testing 

procedure violations 

Tier of public 

notice required Citation Tier of public 

notice required Citation 

I. Violations of National Primary Drinking Water Regulations (NPDWR): 3

A. Microbiological Contaminants 

* * * * * * * 

11. Ground Water Rule violations .................................................................... 2 141.404 3 141.402(h). 

141.403(d). 


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APPENDIX A TO SUBPART Q OF PART 141—NPDWR VIOLATIONS AND OTHER SITUATIONS REQUIRING PUBLIC NOTICE 1—

Continued 

Contaminant 

MCL/MRDL/TT violations 2 Monitoring and testing 

procedure violations 

Tier of public 

notice required Citation Tier of public 

notice required Citation 

* * * * * * * 

IV. Other Situations Requiring Public Notification 

* * * * * * * 

F. Source Water Sample Positive for GWR Fecal indicators: E. coli, 

enterococci, or coliphage .............................................................................. 1 141.402(g) N/A N/A 

* * * * * * * 

1Violations and other situations not listed in this table (e.g., failure to prepare Consumer Confidence Reports) do not require notice, unless 

otherwise determined by the primacy agency. Primacy agencies may, at their option, also require a more stringent public notice tier (e.g., Tier 1 

instead of Tier 2 or Tier 2 instead of Tier 3) for specific violations and situations listed in this Appendix, as authorized under § 141.202(a) and 

§ 141.203(a). 

2 MCL—Maximum contaminant level, MRDL—Maximum residual disinfectant level, TT—Treatment technique. 3The term Violations of National Primary Drinking Water Regulations (NPDWR) is used here to include violations of MCL, MRDL, treatment 

technique, monitoring, and testing procedure requirements. 

* * * * * ■ 11. Appendix B of Subpart Q of Part 

141 is amended by adding entries A.1.c 

and A.1.d in numerical order to read as 

follows: 

APPENDIX B TO SUBPART Q OF PART 141—STANDARD 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 Water Regulations (NPDWR) 

A. Microbiological Contaminants 

* * * * * * * 

1c. Fecal indicators (GWR): 

i. E. coli 

ii. enterococci 

iii. coliphage 

Zero ..............

None .............

None .............

TT ...............

TT 

TT 

Fecal indicators are microbes whose presence indicates that the water may be contaminated with 

human or animal wastes. Microbes in these wastes 

can cause short-term health effects, such as diarrhea, cramps, nausea, headaches, or other symptoms. They may pose a special health risk for infants, young children, some of the elderly, and people with severely compromised immune systems. 

1d. Ground Water Rule (GWR) TT violations ................ None ............. TT ............... Inadequately treated or inadequately protected water 

may contain disease-causing organisms. These organisms can cause symptoms such as diarrhea, 

nausea, cramps, and associated headaches. 

* * * * * * * 

1 MCLG—Maximum contaminant level goal. 2 MCL—Maximum contaminant level. 

* * * * * 

■ 12. Appendix C to Subpart Q is 

amended by adding the following 

abbreviations in alphabetical order: 

Appendix C to Subpart Q of Part 141— 

List of Acronyms Used in Public 

Notification Regulations 

* * * * * 

GWR Ground Water Rule 

* * * * * 

■ 13. A new subpart S is added to read 

as follows: 

Subpart S—Ground Water Rule 

Sec. 

141.400 General requirements and 

applicability. 

141.401 Sanitary surveys for ground water 

systems. 

141.402 Ground water source microbial 

monitoring and analytical methods. 

141.403 Treatment technique requirements 

for ground water systems. 

141.404 Treatment technique violations for 

ground water systems. 

141.405 Reporting and recordkeeping for 

ground water systems. 

Subpart S—Ground Water Rule 

§ 141.400 General requirements and 

applicability. 

(a) Scope of this subpart. The 

requirements of this subpart S constitute 

National Primary Drinking Water 

Regulations. 

(b) Applicability. This subpart applies 

to all public water systems that use 

ground water except that it does not 

apply to public water systems that 

combine all of their ground water with 

surface water or with ground water 

under the direct influence of surface 

water prior to treatment under subpart 


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H. For the purposes of this subpart, 

‘‘ground water system’’ is defined as any 

public water system meeting this 

applicability statement, including 

consecutive systems receiving finished 

ground water. 

(c) General requirements. Systems 

subject to this subpart must comply 

with the following requirements: 

(1) Sanitary survey information 

requirements for all ground water 

systems as described in § 141.401. 

(2) Microbial source water monitoring 

requirements for ground water systems 

that do not treat all of their ground 

water to at least 99.99 percent (4-log) 

treatment of viruses (using inactivation, 

removal, or a State-approved 

combination of 4-log virus inactivation 

and removal) before or at the first 

customer as described in § 141.402. 

(3) Treatment technique requirements, 

described in § 141.403, that apply to 

ground water systems that have fecally 

contaminated source waters, as 

determined by source water monitoring 

conducted under § 141.402, or that have 

significant deficiencies that are 

identified by the State or that are 

identified by EPA under SDWA section 

1445. A ground water system with 

fecally contaminated source water or 

with significant deficiencies subject to 

the treatment technique requirements of 

this subpart must implement one or 

more of the following corrective action 

options: correct all significant 

deficiencies; provide an alternate source 

of water; eliminate the source of 

contamination; or provide treatment 

that reliably achieves at least 4-log 

treatment of viruses (using inactivation, 

removal, or a State-approved 

combination of 4-log virus inactivation 

and removal) before or at the first 

customer. 

(4) Ground water systems that provide 

at least 4-log treatment of viruses (using 

inactivation, removal, or a Stateapproved combination of 4-log virus 

inactivation and removal) before or at 

the first customer are required to 

conduct compliance monitoring to 

demonstrate treatment effectiveness, as 

described in § 141.403(b). 

(5) If requested by the State, ground 

water systems must provide the State 

with any existing information that will 

enable the State to perform a 

hydrogeologic sensitivity assessment. 

For the purposes of this subpart, 

‘‘hydrogeologic sensitivity assessment’’

is a determination of whether ground 

water systems obtain water from 

hydrogeologically sensitive settings. 

(d) Compliance date. Ground water 

systems must comply, unless otherwise 

noted, with the requirements of this 

subpart beginning December 1, 2009. 

§ 141.401 Sanitary surveys for ground 

water systems. 

(a) Ground water systems must 

provide the State, at the State’s request, 

any existing information that will 

enable the State to conduct a sanitary 

survey. 

(b) For the purposes of this subpart, 

a ‘‘sanitary survey,’’ as conducted by the 

State, includes but is not limited to, an 

onsite review of the water source(s) 

(identifying sources of contamination by 

using results of source water 

assessments or other relevant 

information where available), facilities, 

equipment, operation, maintenance, and 

monitoring compliance of a public 

water system to evaluate the adequacy 

of the system, its sources and operations 

and the distribution of safe drinking 

water. 

(c) The sanitary survey must include 

an evaluation of the applicable 

components listed in paragraphs (c)(1) 

through (8) of this section: 

(1) Source, 

(2) Treatment, 

(3) Distribution system, 

(4) Finished water storage, 

(5) Pumps, pump facilities, and 

controls, 

(6) Monitoring, reporting, and data 

verification, 

(7) System management and 

operation, and 

(8) Operator compliance with State 

requirements. 

§ 141.402 Ground water source microbial 

monitoring and analytical methods. 

(a) Triggered source water 

monitoring.—(1) General requirements. 

A ground water system must conduct 

triggered source water monitoring if the 

conditions identified in paragraphs 

(a)(1)(i) and (a)(1)(ii) of this section 

exist. 

(i) The system does not provide at 

least 4-log treatment of viruses (using 

inactivation, removal, or a Stateapproved combination of 4-log virus 

inactivation and removal) before or at 

the first customer for each ground water 

source; and 

(ii) The system is notified that a 

sample collected under § 141.21(a) is 

total coliform-positive and the sample is 

not invalidated under § 141.21(c). 

(2) Sampling Requirements. A ground 

water system must collect, within 24 

hours of notification of the total 

coliform-positive sample, at least one 

ground water source sample from each 

ground water source in use at the time 

the total coliform-positive sample was 

collected under § 141.21(a), except as 

provided in paragraph (a)(2)(ii) of this 

section. 

(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 within 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 more than one ground water source 

may meet the requirements of this 

paragraph (a)(2) by sampling 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 sample 

siting plan under § 141.21(a) and that 

the system intends to use for 

representative sampling under this 

paragraph. 

(iii) A ground water system serving 

1,000 people or fewer 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 paragraph (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 source water 

monitoring under this paragraph (a). If 

the repeat sample collected from the 

ground water source is E.coli positive, 

the system must comply with paragraph 

(a)(3) of this section. 

(3) Additional Requirements. If the 

State does not require corrective 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 invalidated 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 

requirements of this paragraph (a), a 

consecutive ground water system that 

has a total coliform-positive sample 

collected under § 141.21(a) must notify 

the wholesale system(s) within 24 hours 

of being notified of the total coliformpositive sample. 

(ii) In addition to the other 

requirements of this 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 receives notice from a consecutive 

system it serves that a sample collected 

under § 141.21(a) is total coliformpositive 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 


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a fecal indicator under paragraph (c) of 

this section. 

(B) If the sample collected under 

paragraph (a)(4)(ii)(A) of this section is 

fecal indicator-positive, the wholesale 

ground water system must notify all 

consecutive systems served by that 

ground water source of the fecal 

indicator source water 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 

monitoring 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) is caused by a 

distribution system deficiency; or 

(ii) The total coliform-positive sample 

collected under § 141.21(a) is collected 

at a location that meets State criteria for 

distribution system conditions that will 

cause total coliform-positive samples. 

(b) Assessment Source Water 

Monitoring. If directed by the State, 

ground water systems must conduct 

assessment source water monitoring that 

meets State-determined requirements 

for such monitoring. A ground water 

system conducting assessment source 

water monitoring may use a triggered 

source water sample collected under 

paragraph (a)(2) of this section to meet 

the requirements of paragraph (b) of this 

section. State-determined assessment 

source water monitoring requirements 

may include: 

(1) Collection of a total of 12 ground 

water source samples that represent 

each month the system provides ground 

water to the public, 

(2) Collection of samples from each 

well unless the system obtains written 

State approval to conduct monitoring at 

one or more wells within the ground 

water system that are representative of 

multiple wells used by that system and 

that draw water from the same 

hydrogeologic setting, 

(3) Collection of a standard sample 

volume of at least 100 mL for fecal 

indicator analysis regardless of the fecal 

indicator or analytical method used, 

(4) Analysis of all ground water 

source samples using one of the 

analytical methods listed in the in 

paragraph (c)(2) of this section for the 

presence of E. coli, enterococci, or 

coliphage, 

(5) Collection of ground water source 

samples at a location prior to any 

treatment of the ground water source 

unless the State approves a sampling 

location after treatment, and 

(6) Collection of ground water source 

samples at the well itself unless the 

system’s configuration does not allow 

for sampling at the well itself and the 

State approves an alternate sampling 

location that is representative of the 

water quality of that well. 

(c) Analytical methods. (1) A ground 

water system subject to the source water 

monitoring requirements of paragraph 

(a) of this section must collect a 

standard sample volume of at least 100 

mL for fecal indicator analysis 

regardless of the fecal indicator or 

analytical method used. 

(2) A ground water system must 

analyze all ground water source samples 

collected under paragraph (a) of this 

section using one of the analytical 

methods listed in the following table in 

paragraph (c)(2) of this section for the 

presence of E. coli, enterococci, or 

coliphage: 

ANALYTICAL METHODS FOR SOURCE WATER MONITORING

Fecal indicator 1 Methodology Method citation 

E. coli ........................................................................ Colilert 3 ................................................................... 9223 B.2

Colisure 3 ................................................................. 9223 B.2

Membrane Filter Method with MI Agar ................... EPA Method 1604.4

m-ColiBlue24 Test 5 ................................................

E*Colite Test 6 .........................................................

EC–MUG 7 ............................................................... 9221 F.2

NA–MUG 7 ............................................................... 9222 G.2

Enterococci Multiple-Tube Technique ......................................... 9230B.2

Membrane Filter Technique .................................... EPA Method 1600.8

Enterolert 9 ...............................................................

Coliphage .................................................................. Two-Step Enrichment Presence-Absence Procedure.EPA Method 1601.10

Single Agar Layer Procedure .................................. EPA Method 1602.11

Analyses must be conducted in accordance with the documents listed below. The Director of the Federal Register approves the incorporation 

by reference of the documents listed in footnotes 2–11 in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the documents may be 

obtained from the sources listed below. Copies may be inspected at EPA’s Drinking Water Docket, EPA West, 1301 Constitution Avenue, 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/

code_of_federal_regulations/ibr_locations.html. 1The time from sample collection to initiation of analysis may not exceed 30 hours. The ground water system is encouraged but is not required 

to hold samples below 10°C during transit. 2 Methods are described in Standard Methods for the Examination of Water and Wastewater 20th edition (1998) and copies may be obtained 

from the American Public Health Association, 1015 Fifteenth Street, NW., Washington, DC 20005–2605. 3 Medium is available through IDEXX Laboratories, Inc., One IDEXX Drive, Westbrook, Maine 04092. 

4EPA 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. Method is available at http://www.epa.gov/nerlcwww/1604sp02.pdf or from EPA’s Water Resource 

Center (RC–4100T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. 5A description of the m-ColiBlue24 Test, ‘‘Total Coliforms and E. coli Membrane Filtration Method with m-ColiBlue24 Broth,’’ Method No. 

10029 Revision 2, August 17, 1999, is available from Hach Company, 100 Dayton Ave., Ames, IA 50010 or from EPA’s Water Resource Center 

(RC–4100T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. 6A description of the E*Colite Test, ‘‘Charm E*Colite Presence/Absence Test for Detection and Identification of Coliform Bacteria and Escherichia coli in Drinking Water, January 9, 1998, is available from Charm Sciences, Inc., 659 Andover St., Lawrence, MA 01843–1032 or from 

EPA’s Water Resource Center (RC–4100T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. 7EC–MUG (Method 9221F) or NA–MUG (Method 9222G) can be used for E. coli testing step as described in § 141.21(f)(6)(i) or (ii) after use 

of Standard Methods 9221 B, 9221 D, 9222 B, or 9222 C. 


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8EPA Method 1600: Enterococci in Water by Membrane Filtration Using membrane-Enterococcus Indoxyl–b–D–Glucoside Agar (mEI) EPA 

821–R–02–022 (September 2002) is an approved variation of Standard Method 9230C. The method is available at http://www.epa.gov/nerlcwww/ 

1600sp02.pdf or from EPA’s Water Resource Center (RC–4100T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. The holding time 

and temperature for ground water samples are specified in footnote 1 above, rather than as specified in Section 8 of EPA Method 1600. 9 Medium is available through IDEXX Laboratories, Inc., One IDEXX Drive, Westbrook, Maine 04092. Preparation and use of the medium is set 

forth in the article ‘‘Evaluation of Enterolert for Enumeration of Enterococci in Recreational Waters,’’ by Budnick, G.E., Howard, R.T., and Mayo, 

D.R., 1996, Applied and Environmental Microbiology, 62:3881–3884. 10EPA Method 1601: Male-specific (F+) and Somatic Coliphage in Water by Two-step Enrichment Procedure; April 2001, EPA 821–R–01–030. 

Method is available at http://www.epa.gov/nerlcwww/1601ap01.pdf or from EPA’s Water Resource Center (RC–4100T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. 11EPA Method 1602: Male-specific (F+) and Somatic Coliphage in Water by Single Agar Layer (SAL) Procedure; April 2001, EPA 821–R–01–

029. Method is available at http://www.epa.gov/nerlcwww/1602ap01.pdf or from EPA’s Water Resource Center (RC–4100T), 1200 Pennsylvania 

Avenue, NW., Washington, DC 20460. 

(d) Invalidation of a fecal indicatorpositive ground water source sample. (1) 

A ground water system may obtain State 

invalidation of a fecal indicator-positive 

ground water source sample collected 

under paragraph (a) of this section only 

under the conditions specified in 

paragraphs (d)(1)(i) and (ii) of this 

section. 

(i) The system provides the State with 

written notice from the laboratory that 

improper sample analysis occurred; or 

(ii) The State determines and 

documents in writing that there is 

substantial evidence that a fecal 

indicator-positive ground water source 

sample is not related to source water 

quality. 

(2) If the State invalidates a fecal 

indicator-positive ground water source 

sample, the ground water system must 

collect another source water sample 

under paragraph (a) of this section 

within 24 hours of being notified by the 

State of its invalidation decision and 

have it analyzed for the same fecal 

indicator using the analytical methods 

in paragraph (c) of this section. The 

State may extend the 24-hour time limit 

on a case-by-case basis if the system 

cannot collect the source water sample 

within 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. 

(e) Sampling location. (1) Any ground 

water source sample required under 

paragraph (a) of this section must be 

collected at a location prior to any 

treatment of the ground water source 

unless the State approves a sampling 

location after treatment. 

(2) If the system’s configuration does 

not allow for sampling at the well itself, 

the system may collect a sample at a 

State-approved location to meet the 

requirements of paragraph (a) of this 

section if the sample is representative of 

the water quality of that well. 

(f) New Sources. If directed by the 

State, a ground water system that places 

a new ground water source into service 

after November 30, 2009, must conduct 

assessment source water monitoring 

under paragraph (b) of this section. If 

directed by the State, the system must 

begin monitoring before the ground 

water source is used to provide water to 

the public. 

(g) Public Notification. A ground 

water system with a ground water 

source sample collected under 

paragraph (a) or (b) of this section that 

is fecal indicator-positive and that is not 

invalidated under paragraph (d) of this 

section, including consecutive systems 

served by the ground water source, must 

conduct public notification under 

§ 141.202. 

(h) Monitoring Violations. Failure to 

meet the requirements of paragraphs 

(a)–(f) of this section is a monitoring 

violation and requires the ground water 

system to provide public notification 

under § 141.204. 

§ 141.403 Treatment technique 

requirements for ground water systems. 

(a) Ground water systems with 

significant deficiencies or source water 

fecal contamination. 

(1) The treatment technique 

requirements of this section must be met 

by ground water systems when a 

significant deficiency is identified or 

when a ground water source sample 

collected under § 141.402(a)(3) is fecal 

indicator-positive. 

(2) If directed by the State, a ground 

water system with a ground water 

source sample collected under 

§ 141.402(a)(2), § 141.402(a)(4), or 

§ 141.402(b) that is fecal indicatorpositive must comply with the 

treatment technique requirements of 

this section. 

(3) When a significant deficiency is 

identified at a Subpart H public water 

system that uses both ground water and 

surface water or ground water under the 

direct influence of surface water, the 

system must comply with provisions of 

this paragraph except in cases where the 

State determines that the significant 

deficiency is in a portion of the 

distribution system that is served solely 

by surface water or ground water under 

the direct influence of surface water. 

(4) Unless the State directs the ground 

water system to implement a specific 

corrective action, the ground water 

system must consult with the State 

regarding the appropriate corrective 

action within 30 days of receiving 

written notice from the State of a 

significant deficiency, written notice 

from a laboratory that a ground water 

source sample collected under 

§ 141.402(a)(3) was found to be fecal 

indicator-positive, or direction from the 

State that a fecal indicator’positive 

collected under § 141.402(a)(2), 

§ 141.402(a)(4), or § 141.402(b) requires 

corrective action. For the purposes of 

this subpart, significant deficiencies 

include, but are not limited to, defects 

in design, operation, or maintenance, or 

a failure or malfunction of the sources, 

treatment, storage, or distribution 

system that the State determines to be 

causing, or have potential for causing, 

the introduction of contamination into 

the water delivered to consumers. 

(5) Within 120 days (or earlier if 

directed by the State) of receiving 

written notification from the State of a 

significant deficiency, written notice 

from a laboratory that a ground water 

source sample collected under 

§ 141.402(a)(3) was found to be fecal 

indicator-positive, or direction from the 

State that a fecal indicator-positive 

sample collected under § 141.402(a)(2), 

§ 141.402(a)(4), or § 141.402(b) requires 

corrective action, the ground water 

system must either: 

(i) Have completed corrective action 

in accordance with applicable State 

plan review processes or other State 

guidance or direction, if any, including 

State-specified interim measures; or 

(ii) Be in compliance with a Stateapproved corrective action plan and 

schedule subject to the conditions 

specified in paragraphs (a)(5)(ii)(A) and 

(a)(5)(ii)(B) of this section. 

(A) Any subsequent modifications to 

a State-approved corrective action plan 

and schedule must also be approved by 

the State. 

(B) If the State specifies interim 

measures for protection of the public 

health pending State approval of the 

corrective action plan and schedule or 

pending completion of the corrective 

action plan, the system must comply 

with these interim measures as well as 


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with any schedule specified by the 

State. 

(6) Corrective Action Alternatives. 

Ground water systems that meet the 

conditions of paragraph (a)(1) or (a)(2) of 

this section must implement one or 

more of the following corrective action 

alternatives: 

(i) Correct all significant deficiencies; 

(ii) Provide an alternate source of 

water; 

(iii) Eliminate the source of 

contamination; or 

(iv) Provide treatment that reliably 

achieves at least 4-log treatment of 

viruses (using inactivation, removal, or 

a State-approved combination of 4-log 

virus inactivation and removal) before 

or at the first customer for the ground 

water source. 

(7) Special notice to the public of 

significant deficiencies or source water 

fecal contamination. (i) In addition to 

the applicable public notification 

requirements of § 141.202, a community 

ground water system that receives 

notice from the State of a significant 

deficiency or notification of a fecal 

indicator-positive ground water source 

sample that is not invalidated by the 

State under § 141.402(d) must inform 

the public served by the water system 

under § 141.153(h)(6) of the fecal 

indicator-positive source sample or of 

any significant deficiency that has not 

been corrected. The system must 

continue to inform the public annually 

until the significant deficiency is 

corrected or the fecal contamination in 

the ground water source is determined 

by the State to be corrected under 

paragraph (a)(5) of this section. 

(ii) In addition to the applicable 

public notification requirements of 

§ 141.202, a non-community ground 

water system that receives notice from 

the State of a significant deficiency must 

inform the public served by the water 

system in a manner approved by the 

State of any significant deficiency that 

has not been corrected within 12 

months of being notified by the State, or 

earlier if directed by the State. The 

system must continue to inform the 

public annually until the significant 

deficiency is corrected. The information 

must include: 

(A) The nature of the significant 

deficiency and the date the significant 

deficiency was identified by the State; 

(B) The State-approved plan and 

schedule for correction of the significant 

deficiency, including interim measures, 

progress to date, and any interim 

measures completed; and 

(C) For systems with a large 

proportion of non-English speaking 

consumers, as determined by the State, 

information in the appropriate 

language(s) regarding the importance of 

the notice or a telephone number or 

address where consumers may contact 

the system to obtain a translated copy of 

the notice or assistance in the 

appropriate language. 

(iii) If directed by the State, a noncommunity water system with 

significant deficiencies that have been 

corrected must inform its customers of 

the significant deficiencies, how the 

deficiencies were corrected, and the 

dates of correction under paragraph 

(a)(7)(ii) of this section. 

(b) Compliance monitoring—(1) 

Existing ground water sources. A ground 

water system that is not required to 

meet the source water monitoring 

requirements of this subpart for any 

ground water source because it provides 

at least 4-log treatment of viruses (using 

inactivation, removal, or a Stateapproved combination of 4-log virus 

inactivation and removal) before or at 

the first customer for any ground water 

source before December 1, 2009, must 

notify the State in writing that it 

provides at least 4-log treatment of 

viruses (using inactivation, removal, or 

a State-approved combination of 4-log 

virus inactivation and removal) before 

or at the first customer for the specified 

ground water source and begin 

compliance monitoring in accordance 

with paragraph (b)(3) of this section by 

December 1, 2009. Notification to the 

State must include engineering, 

operational, or other information that 

the State requests to evaluate the 

submission. If the system subsequently 

discontinues 4-log treatment of viruses 

(using inactivation, removal, or a Stateapproved combination of 4-log virus 

inactivation and removal) before or at 

the first customer for a ground water 

source, the system must conduct ground 

water source monitoring as required 

under § 141.402. 

(2) New ground water sources. A 

ground water system that places a 

ground water source in service after 

November 30, 2009, that is not required 

to meet the source water monitoring 

requirements of this subpart because the 

system provides at least 4-log treatment 

of viruses (using inactivation, removal, 

or a State-approved combination of 4- 

log virus inactivation and removal) 

before or at the first customer for the 

ground water source must comply with 

the requirements of paragraphs (b)(2)(i), 

(b)(2)(ii) and (b)(2)(iii) of this section. 

(i) The system must notify the State in 

writing that it provides at least 4-log 

treatment of viruses (using inactivation, 

removal, or a State-approved 

combination of 4-log virus inactivation 

and removal) before or at the first 

customer for the ground water source. 

Notification to the State must include 

engineering, operational, or other 

information that the State requests to 

evaluate the submission. 

(ii) The system must conduct 

compliance monitoring as required 

under § 141.403(b)(3) of this subpart 

within 30 days of placing the source in 

service. 

(iii) The system must conduct ground 

water source monitoring under 

§ 141.402 if the system subsequently 

discontinues 4-log treatment of viruses 

(using inactivation, removal, or a Stateapproved combination of 4-log virus 

inactivation and removal) before or at 

the first customer for the ground water 

source. 

(3) Monitoring requirements. A 

ground water system subject to the 

requirements of paragraphs (a), (b)(1) or 

(b)(2) of this section must monitor the 

effectiveness and reliability of treatment 

for that ground water source before or at 

the first customer as follows: 

(i) Chemical disinfection—(A) Ground 

water systems serving greater than 3,300 

people. A ground water system that 

serves greater than 3,300 people must 

continuously monitor the residual 

disinfectant concentration using 

analytical methods specified in 

§ 141.74(a)(2) at a location approved by 

the State and must record the lowest 

residual disinfectant concentration each 

day that water from the ground water 

source is served to the public. The 

ground water system must maintain the 

State-determined residual disinfectant 

concentration every day the ground 

water system serves water from the 

ground water source to the public. If 

there is a failure in the continuous 

monitoring equipment, the ground 

water system must conduct grab 

sampling every four hours until the 

continuous monitoring equipment is 

returned to service. The system must 

resume continuous residual disinfectant 

monitoring within 14 days. 

(B) Ground water systems serving 

3,300 or fewer people. A ground water 

system that serves 3,300 or fewer people 

must monitor the residual disinfectant 

concentration using analytical methods 

specified in § 141.74(a)(2) at a location 

approved by the State and record the 

residual disinfection concentration each 

day that water from the ground water 

source is served to the public. The 

ground water system must maintain the 

State-determined residual disinfectant 

concentration every day the ground 

water system serves water from the 

ground water source to the public. The 

ground water system must take a daily 

grab sample during the hour of peak 

flow or at another time specified by the 

State. If any daily grab sample 


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measurement falls below the Statedetermined residual disinfectant 

concentration, the ground water system 

must take follow-up samples every four 

hours until the residual disinfectant 

concentration is restored to the Statedetermined level. Alternatively, a 

ground water system that serves 3,300 

or fewer people may monitor 

continuously and meet the requirements 

of paragraph (b)(3)(i)(A) of this section. 

(ii) Membrane filtration. A ground 

water system that uses membrane 

filtration to meet the requirements of 

this subpart must monitor the 

membrane filtration process in 

accordance with all State-specified 

monitoring requirements and must 

operate the membrane filtration in 

accordance with all State-specified 

compliance requirements. A ground 

water system that uses membrane 

filtration is in compliance with the 

requirement to achieve at least 4-log 

removal of viruses when: 

(A) The membrane has an absolute 

molecular weight cut-off (MWCO), or an 

alternate parameter that describes the 

exclusion characteristics of the 

membrane, that can reliably achieve at 

least 4-log removal of viruses; 

(B) The membrane process is operated 

in accordance with State-specified 

compliance requirements; and 

(C) The integrity of the membrane is 

intact. 

(iii) Alternative treatment. A ground 

water system that uses a State-approved 

alternative treatment to meet the 

requirements of this subpart by 

providing at least 4-log treatment of 

viruses (using inactivation, removal, or 

a State-approved combination of 4-log 

virus inactivation and removal) before 

or at the first customer must: 

(A) Monitor the alternative treatment 

in accordance with all State-specified 

monitoring requirements; and 

(B) Operate the alternative treatment 

in accordance with all compliance 

requirements that the State determines 

to be necessary to achieve at least 4-log 

treatment of viruses. 

(c) Discontinuing treatment. A ground 

water system may discontinue 4-log 

treatment of viruses (using inactivation, 

removal, or a State-approved 

combination of 4-log virus inactivation 

and removal) before or at the first 

customer for a ground water source if 

the State determines and documents in 

writing that 4-log treatment of viruses is 

no longer necessary for that ground 

water source. A system that 

discontinues 4-log treatment of viruses 

is subject to the source water monitoring 

and analytical methods requirements of 

§ 141.402 of this subpart. 

(d) Failure to meet the monitoring 

requirements of paragraph (b) of this 

section is a monitoring violation and 

requires the ground water system to 

provide public notification under 

§ 141.204. 

§ 141.404 Treatment technique violations 

for ground water systems. 

(a) A ground water system with a 

significant deficiency is in violation of 

the treatment technique requirement if, 

within 120 days (or earlier if directed by 

the State) of receiving written notice 

from the State of the significant 

deficiency, the system: 

(1) Does not complete corrective 

action in accordance with any 

applicable State plan review processes 

or other State guidance and direction, 

including State specified interim actions 

and measures, or 

(2) Is not in compliance with a Stateapproved corrective action plan and 

schedule. 

(b) Unless the State invalidates a fecal 

indicator-positive ground water source 

sample under § 141.402(d), a ground 

water system is in violation of the 

treatment technique requirement if, 

within 120 days (or earlier if directed by 

the State) of meeting the conditions of 

§ 141.403(a)(1) or § 141.403(a)(2), the 

system: 

(1) Does not complete corrective 

action in accordance with any 

applicable State plan review processes 

or other State guidance and direction, 

including State-specified interim 

measures, or 

(2) Is not in compliance with a Stateapproved corrective action plan and 

schedule. 

(c) A ground water system subject to 

the requirements of § 141.403(b)(3) that 

fails to maintain at least 4-log treatment 

of viruses (using inactivation, removal, 

or a State-approved combination of 4- 

log virus inactivation and removal) 

before or at the first customer for a 

ground water source is in violation of 

the treatment technique requirement if 

the failure is not corrected within four 

hours of determining the system is not 

maintaining at least 4-log treatment of 

viruses before or at the first customer. 

(d) Ground water system must give 

public notification under § 141.203 for 

the treatment technique violations 

specified in paragraphs (a), (b) and (c) 

of this section. 

§ 141.405 Reporting and recordkeeping for 

ground water systems. 

(a) Reporting. In addition to the 

requirements of § 141.31, a ground 

water system regulated under this 

subpart must provide the following 

information to the State: 

(1) A ground water system conducting 

compliance monitoring under 

§ 141.403(b) must notify the State any 

time the system fails to meet any Statespecified requirements including, but 

not limited to, minimum residual 

disinfectant concentration, membrane 

operating criteria or membrane integrity, 

and alternative treatment operating 

criteria, if operation in accordance with 

the criteria or requirements is not 

restored within four hours. The ground 

water system must notify the State as 

soon as possible, but in no case later 

than the end of the next business day. 

(2) After completing any corrective 

action under § 141.403(a), a ground 

water system must notify the State 

within 30 days of completion of the 

corrective action. 

(3) If a ground water system subject to 

the requirements of § 141.402(a) does 

not conduct source water monitoring 

under § 141.402(a)(5)(ii), the system 

must provide documentation to the 

State within 30 days of the total 

coliform positive sample that it met the 

State criteria. 

(b) Recordkeeping. In addition to the 

requirements of § 141.33, a ground 

water system regulated under this 

subpart must maintain the following 

information in its records: 

(1) Documentation of corrective 

actions. Documentation shall be kept for 

a period of not less than ten years. 

(2) Documentation of notice to the 

public as required under § 141.403(a)(7). 

Documentation shall be kept for a 

period of not less than three years. 

(3) Records of decisions under 

§ 141.402(a)(5)(ii) and records of 

invalidation of fecal indicator-positive 

ground water source samples under 

§ 141.402(d). Documentation shall be 

kept for a period of not less than five 

years. 

(4) For consecutive systems, 

documentation of notification to the 

wholesale system(s) of total-coliform 

positive samples that are not invalidated 

under § 141.21(c). Documentation shall 

be kept for a period of not less than five 

years. 

(5) For systems, including wholesale 

systems, that are required to perform 

compliance monitoring under 

§ 141.403(b): 

(i) Records of the State-specified 

minimum disinfectant residual. 

Documentation shall be kept for a 

period of not less than ten years. 

(ii) Records of the lowest daily 

residual disinfectant concentration and 

records of the date and duration of any 

failure to maintain the State-prescribed 

minimum residual disinfectant 

concentration for a period of more than 


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four hours. Documentation shall be kept 

for a period of not less than five years. 

(iii) Records of State-specified 

compliance requirements for membrane 

filtration and of parameters specified by 

the State for State-approved alternative 

treatment and records of the date and 

duration of any failure to meet the 

membrane operating, membrane 

integrity, or alternative treatment 

operating requirements for more than 

four hours. Documentation shall be kept 

for a period of not less than five years. 

PART 142—NATIONAL PRIMARY 

DRINKING WATER REGULATIONS 

IMPLEMENTATION 

■ 14. 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. 

■ 15. Section 142.14 is amended by 

adding paragraph (d)(17) to read as 

follows: 

§ 142.14 Records kept by States. 

* * * * * 

(d) * * * 

(17) Records of the currently 

applicable or most recent State 

determination, including all supporting 

information and an explanation of the 

technical basis of each decision, made 

under the following provisions of 40 

CFR part 141, subpart S and 40 CFR part 

142. 

(i) Section 142.16(o)(2)(v). Records of 

written notices of significant 

deficiencies. 

(ii) Section 141.403(a)(5)(ii) of this 

chapter. Records of corrective action 

plans, schedule approvals, and Statespecified interim measures. 

(iii) Section 142.16(o)(4). Records of 

confirmations under § 141.403(a) of this 

chapter that a significant deficiency has 

been corrected or the fecal 

contamination in the ground water 

source has been addressed. 

(iv) Section 141.402(a)(5) of this 

chapter. Records of State determinations 

and records of ground water system’s 

documentation for not conducting 

triggered source water monitoring. 

(v) Section 141.402(d) of this chapter. 

Records of invalidations of fecal 

indicator-positive ground water source 

samples. 

(vi) Section 141.402(a)(2)(ii) of this 

chapter. Records of State approvals of 

source water monitoring plans. 

(vii) Section 142.16(o)(4)(ii). Records 

of notices of the minimum residual 

disinfection concentration (when using 

chemical disinfection) needed to 

achieve at least 4-log virus inactivation 

before or at the first customer. 

(viii) Sections 142.16(o)(4)(iv) and 

142.16(o)(4)(v) Records of notices of the 

State-specified monitoring and 

compliance requirements (when using 

membrane filtration or alternative 

treatment) needed to achieve at least 4- 

log treatment of viruses (using 

inactivation, removal, or a Stateapproved combination of 4-log 

inactivation and removal) before or at 

the first customer. 

(ix) Sections 141.403(b)(1) and 

141.403(b)(2) of this chapter. Records of 

written notices from the ground water 

system that it provides at least 4-log 

treatment of viruses (using inactivation, 

removal, or a State-approved 

combination of 4-log virus inactivation 

and removal) before or at the first 

customer for a ground water source. 

(x) Section 142.16(o)(4)(vi). Records of 

written determinations that the ground 

water system may discontinue 4-log 

treatment of viruses (using inactivation, 

removal, or a State-approved 

combination of 4-log inactivation and 

removal). 

* * * * * 

■ 16. Section 142.15 is amended by 

adding paragraph (c)(7) to read as 

follows: 

§ 142.15 Reports by States. 

* * * * * 

(c) * * * 

(7) Ground water rule. (i) Sanitary 

surveys. The month and year in which 

the most recent sanitary survey was 

completed or, for a State that uses a 

phased review process, the date the last 

element of the applicable eight elements 

was evaluated under § 142.16(o)(2) for 

each ground water system. 

(ii) Corrective action requirements. 

For any corrective action under 

§ 141.403(a) of this chapter, the date the 

ground water system completed 

corrective action. 

(iii) Compliance monitoring. All 

ground water systems providing at least 

4-log treatment of viruses (using 

inactivation, removal, or a Stateapproved combination of 4-log virus 

inactivation and removal) before or at 

the first customer for any ground water 

source(s). 

* * * * * 

■ 17. Section 142.16 is amended as 

follows: 

■ a. Revise paragraph (a)(2)(iii), and 

■ b. Add paragraph (o) to read as 

follows: 

§ 142.16 Special primacy requirements. 

(a) * * * 

(2) * * * 

(iii) Table 1 of 40 CFR 141.202(a) 

(Items (5), (6), and (9))—To require 

public water systems to give a Tier 1 

public notice (rather than a Tier 2 or 

Tier 3 notice) for violations or situations 

listed in Appendix A of Subpart Q of 

Part 141 of this chapter; 

(o) Requirements for States to adopt 

40 CFR part 141, subpart S. In addition 

to the general primacy requirements 

specified elsewhere in this part, 

including the requirement that State 

regulations are no less stringent than the 

Federal requirements, an application for 

approval of a State program revision 

that adopts 40 CFR part 141, subpart S, 

must contain the information specified 

in this paragraph (o). 

(1) Legal authority. The application 

for primacy must demonstrate the State 

has: 

(i) The authority contained in statute 

or regulation to ensure that ground 

water systems conduct source water 

monitoring under § 141.402(a)(2), 

§ 141.402(a)(3) and § 141.402(a)(4)(ii)(A) 

of this chapter. 

(ii) The authority contained in statute 

or regulation to ensure that ground 

water systems take the appropriate 

corrective actions including interim 

measures, if necessary, needed to 

address significant deficiencies. 

(iii) The authority contained in statute 

or regulation to ensure that ground 

water systems take the appropriate 

corrective actions, including interim 

measures if necessary, to address any 

source water fecal contamination 

identified during source water 

monitoring under § 141.402 of this 

chapter. 

(iv) The authority contained in statute 

or regulation to ensure that ground 

water systems consult with the State 

regarding corrective action(s). 

(2) State practices or procedures for 

sanitary surveys. In addition to the 

general requirements for sanitary 

surveys contained in § 142.10(b)(2), a 

primacy application must describe how 

the State will implement a sanitary 

survey program that meets the 

requirements of paragraph (o)(2)(i) of 

this section. A ‘‘sanitary survey,’’ as 

conducted by the State, includes but is 

not limited to, an onsite review of the 

water source(s) (identifying sources of 

contamination by using results of source 

water assessments or other relevant 

information where available), facilities, 

equipment, operation, maintenance, and 

monitoring compliance of a public 

water system to evaluate the adequacy 

of the system, its sources and operations 

and the distribution of safe drinking 

water. 

(i) The State must conduct sanitary 

surveys that address the eight sanitary 

survey components listed in this section 

no less frequently than every three years 


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for community water systems, except as 

provided in paragraph (o)(2)(iii) of this 

section, and every five years for noncommunity water systems. The State 

may conduct more frequent sanitary 

surveys for any system. The initial 

sanitary survey for each community 

water system must be conducted by 

December 31, 2012, unless the system 

meets the requirements of paragraph 

(o)(2)(iii) of this section. The initial 

sanitary survey for each community 

water system that meets the 

requirements of paragraph (o)(2)(iii) of 

this section and for each noncommunity water system must be 

conducted by December 31, 2014. The 

sanitary survey must include an 

evaluation of each of the following 

elements as applicable: 

(A) Source, 

(B) Treatment, 

(C) Distribution system, 

(D) Finished water storage, 

(E) Pumps, pump facilities, and 

controls, 

(F) Monitoring, reporting, and data 

verification, 

(G) System management and 

operation, and 

(H) Operator compliance with State 

requirements. 

(ii) The State may use a phased 

review process to meet the requirements 

of (o)(2)(i) of this section if all the 

applicable elements of paragraphs 

(o)(2)(i)(A) through (o)(2)(i)(H) of this 

section are evaluated within the 

required interval. 

(iii) The State may conduct sanitary 

surveys once every five years for 

community water systems if the system 

either provides at least 4-log treatment 

of viruses (using inactivation, removal, 

or a State-approved combination of 

4-log inactivation and removal) before 

or at the first customer for all its ground 

water sources, or if it has an outstanding 

performance record, as determined by 

the State and documented in previous 

sanitary surveys and has no history of 

total coliform MCL or monitoring 

violations under § 141.21 of this chapter 

since the last sanitary survey. In its 

primacy application, the State must 

describe how it will determine whether 

a community water system has an 

outstanding performance record. 

(iv) The State must define and 

describe in its primacy application at 

least one specific significant deficiency 

in each of the eight sanitary survey 

elements in paragraphs (o)(2)(i)(A) 

through (o)(2)(i)(H) of this section. 

Significant deficiencies include, but are 

not limited to, defects in design, 

operation, or maintenance, or a failure 

or malfunction of the sources, treatment, 

storage, or distribution system that the 

State determines to be causing, or have 

potential for causing, the introduction of 

contamination into the water delivered 

to consumers. 

(v) As a condition of primacy, the 

State must provide ground water 

systems with written notice describing 

any significant deficiencies no later than 

30 days after the State identifies the 

significant deficiency. The notice may 

specify corrective actions and deadlines 

for completion of corrective actions. The 

State may provide the written notice at 

the time of the sanitary survey. 

(3) State practices or procedures for 

source water microbial monitoring. The 

State’s primacy application must 

include a description of the following: 

(i) The criteria the State will use 

under §§ 141.402(a)(2)(i) and 

141.402(d)(2) of this chapter for 

extending the 24-hour time limit for a 

system to collect a ground water source 

sample to comply with the source water 

monitoring requirements. 

(ii) The criteria the State will use 

under §§ 141.402(a)(5)(i) and 

141.402(a)(5)(ii) of this chapter to 

determine whether the cause of the total 

coliform-positive sample taken under 

§ 141.21(a) of this chapter is directly 

related to the distribution system. 

(iii) The criteria the State will use for 

determining whether to invalidate a 

fecal indicator-positive ground water 

source sample under § 141.402(d)(1)(ii) 

of this chapter. 

(iv) The criteria the State will use to 

allow source water microbial 

monitoring at a location after treatment 

under § 141.402(e)(1) of this chapter. 

(4) State practices or procedures for 

treatment technique requirements. As a 

condition of primacy, the State must 

verify that significant deficiencies or 

source water fecal contamination have 

been addressed. The State must verify 

within 30 days after the ground water 

system has reported to the State that it 

has completed corrective action. The 

State must verify either through written 

confirmation from the ground water 

system or a site visit by the State. 

Written notice from the ground water 

system under § 141.405(a)(2) of this 

chapter may serve as this verification. 

The State’s primacy application must 

include the following: 

(i) The process the State will use to 

determine that a ground water system 

achieves at least a 4-log treatment of 

viruses (using inactivation, removal, or 

a combination of inactivation and 

removal) before or at the first customer 

for a ground water source for systems 

that are not subject to the source water 

monitoring requirements of § 141.402(a) 

of this chapter because the ground water 

system has informed the State that it 

provides at least 4-log treatment of 

viruses. 

(ii) The process the State will use to 

determine the minimum residual 

disinfectant concentration the system 

must provide prior to the first customer 

for systems using chemical disinfection. 

(iii) The State-approved alternative 

technologies that ground water systems 

may use alone or in combination with 

other approved technologies to achieve 

at least 4-log treatment of viruses (using 

inactivation, removal, or a Stateapproved combination of 4-log 

inactivation and removal) before or at 

the first customer for a ground water 

source. 

(iv) The monitoring and compliance 

requirements the State will require for 

ground water systems treating to at least 

4-log treatment of viruses (using 

inactivation, removal, or a Stateapproved combination of inactivation 

and removal) before or at the first 

customer for State-approved alternative 

treatment technologies. 

(v) The monitoring, compliance and 

membrane integrity testing requirements 

the State will require to demonstrate 

virus removal for ground water systems 

using membrane filtration technologies. 

(vi) The criteria, including public 

health-based considerations and 

incorporating on-site investigations and 

source water monitoring results the 

State will use to determine if a ground 

water system may discontinue 4-log 

treatment of viruses (using inactivation, 

removal, or a State-approved 

combination of inactivation and 

removal) before or at the first customer. 

* * * * * 

[FR Doc. 06–8763 Filed 11–7–06; 8:45 am] 

BILLING CODE 6560–50–P 


rwilkins on PROD1PC63 with RULES_2