30194 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 141 and 142

[WH–FRL–6584–4]

RIN 2040–AA97

National Primary Drinking Water

Regulations: Ground Water Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of proposed rulemaking.

SUMMARY: EPA is proposing to require a

targeted risk-based regulatory strategy

for all ground water systems. The

proposed requirements provide a

meaningful opportunity to reduce

public health risk associated with the

consumption of waterborne pathogens

from fecal contamination for a

substantial number of people served by

ground water sources.

The proposed strategy addresses risks

through a multiple-barrier approach that

relies on five major components:

periodic sanitary surveys of ground

water systems requiring the evaluation

of eight elements and the identification

of significant deficiencies;

hydrogeologic assessments to identify

wells sensitive to fecal contamination;

source water monitoring for systems

drawing from sensitive wells without

treatment or with other indications of

risk; a requirement for correction of

significant deficiencies and fecal

contamination (by eliminating the

source of contamination, correcting the

significant deficiency, providing an

alternative source water, or providing a

treatment which achieves at least 99.99

percent (4-log) inactivation or removal

of viruses), and compliance monitoring

to insure disinfection treatment is

reliably operated where it is used.

EPA believes that the combination of

these components strikes an appropriate

regulatory balance which tailors the

intensity or burden of protective

measures and follow-up actions with

the risk being addressed. In addition to

proposing requirements for ground

water systems, EPA requests comment

on ways to address the problem of

transient providers of water who furnish

drinking water to large numbers of

people for a limited period of time. One

possible solution is to adopt alternative

definitions for ‘‘public water systems’’

which is currently defined as ‘‘one that

serves 25 or more people or has 15 or

more service connections and operates

at least 60 days per year. EPA is only

requesting comment on this issue. The

Agency is not today proposing to change

the definition of ‘‘public water system ,’’

or modify related provisions. If EPA

decides to take action on this issue, EPA

will publish a proposal at a later date.

DATES: The EPA must receive comments

on or before July 10, 2000.

ADDRESSES: References, supporting

documents and public comments (and

additional comments as they are

provided) are available for review at

EPA’s Drinking Water Docket #W–98–

23: 401 M Street, SW, Washington, DC

20460 from 9 a.m. to 4 p.m., Eastern

Time, Monday through Friday,

excluding Federal holidays.

You may submit comments by mail to

the docket at: 1200 Pennsylvania Ave.,

NW, Washington, DC 20460 or by

sending electronic mail (e-mail) to owdocket@epa.gov. Hand deliveries should

be delivered to: EPA’s Drinking Water

Docket at 401 M Street, SW,

Washington, DC 20460.

For access to docket materials, please

call 202/260–3027 to schedule an

appointment and obtain the room

number.

FOR FURTHER INFORMATION CONTACT: For

general information, contact the Safe

Drinking Water Hotline, telephone (800)

426–4791. The Safe Drinking Water

Hotline is open Monday through Friday,

excluding Federal holidays, from 9 a.m.

to 5:30 p.m. Eastern Time. For technical

inquiries, contact the Office of Ground

Water and Drinking Water (MC 4607),

U.S. Environmental Protection Agency,

1200 Pennsylvania Ave., N.W.

Washington, DC 20460; telephone (202)

260–3309.

SUPPLEMENTARY INFORMATION:

Regulated Entities

Entities potentially regulated by the

Ground Water Rule are public water

systems using ground water. Regulated

categories and entities include:

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 this table could also be

regulated. To determine whether your

facility is regulated by this action, you

should carefully examine the

applicability criteria in § 141.400(b) of

this proposed rule. If you have

questions regarding the applicability of

this action to a particular entity, consult

the person listed in the preceding

section entitled FOR FURTHER

INFORMATION CONTACT.

Abbreviations Used in This Notice

AWWA: American Water Works Association

ASDWA: Association of State Drinking Water

Administrators

AWWARF: American Water Works

Association Research Foundation

BMP: Best Management Practice

CDC: Centers for Disease Control and

Prevention

CT: The residual concentration of

disinfectant multiplied by the contact time

CWS: community water system

CWSS: Community Water System Survey

DBP: disinfection byproducts

ELR: Environmental Law Reporter

EPA: Environmental Protection Agency

FR: Federal Register

GAO: Government Accounting Office

GWR: Ground Water Rule

GWS: ground water system

HAA5: Haloacetic acids consisting of the sum

of mono-, di-, and trichloroacetic acids,

and mono-and dibromoacetic acids

HAV: Hepatitis A Virus

ICR: Information Collection Rule

IESWTR: Interim Enhanced Surface Water

Treatment Rule

IT: UV irradiance multiplied by the contact

time

m: meter

ml: milliliters

MCL: maximum contaminant level

MCLG: maximum contaminant level goal

mg/L: milligrams per liter

MPN: most probable number

MWCO: molecular weight cut-off

NCWS: non-community water system

NTNCWS: non-transient non-community

water system

PCR: polymerase chain reaction

PWS: public water system

RO: reverse osmosis

RT–PCR: reverse-transcriptase, polymerase

chain reaction

SBREFA: Small Business Regulatory

Enforcement Fairness Act

SDWA: Safe Drinking Water Act

SDWIS: Safe Drinking Water Information

System

Stage 1 DBPR: Stage 1 Disinfectants/

Disinfection Byproducts Rule

Stage 2 DBPR: Stage 2 Disinfectants/

Disinfection Byproducts Rule

SWAPP: Source Water Assessment and

Protection Program

SWTR: Surface Water Treatment Rule

TCR: Total Coliform Rule

TNCWS: transient non-community water

system

TTHM: total trihalomethanes

UIC: Underground Injection Control

USGS: United States Geological Survey

US EPA: United States Environmental

Protection Agency

UV: ultraviolet radiation

WHP: Wellhead Protection

Table of Contents

I. Introduction and Background

A. Statutory Authority

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30195

B. Existing Regulations

1. Total Coliform Rule

2. Surface Water Treatment Rule and

Interim Enhanced Surface Water

Treatment Rule

3. Information Collection Rule

4. Stage 1 Disinfectants/Disinfection

ByProducts Rule

5. Underground Injection Control Program

6. Source Water Assessment and Protection

Program (SWAPP) and the Wellhead

Protection (WHP) Program

C. Industry Profile—Baseline Information

1. Definitions and Data Sources

2. Alternate Definition of ‘‘Public Water

System’’ and the Problem of Short-term

Water Providers

3. Number and Size of Ground Water

Systems

4. Location of Ground Water Systems

5. Ownership of Ground Water Systems

D. Effectiveness of Various Best Management

Practices in Ground Water Systems

1. EPA Report on State Ground Water

Management Practices

2. ASDWA Analysis of BMPs for

Community Ground Water Systems

3. EPA Report on Ground Water

Disinfection and Protective Practices

E. Outreach Activities

1. Public Meetings

2. Review and Comment of Preliminary

Draft GWR Preamble

II. Public Health Risk

A. Introduction

B. Waterborne Disease Outbreak Data

C. Ground Water Occurrence Studies

1. Abbaszadegan et al. (1999) (AWWARF

Study)

2. Lieberman et al. (1994, 1999) (EPA/

AWWARF Study)

3. Missouri Ozark Aquifer Study #1

4. Missouri Ozark Aquifer Study #2

5. Missouri Alluvial Aquifer Study

6. Wisconsin Migrant Worker Camp Study

7. EPA Vulnerability Study

8. US-Mexico Border Study

9. Whittier, California, Coliphage Study

10. Oahu, Hawaii Study

11. New England Study

12. California Study

13. Three State PWS Study (Wisconsin,

Maryland and Minnesota)

D. Health Effects of Waterborne Viral and

Bacterial Pathogens

E. Risk Estimate

1. Baseline Risk Characterization

2. Summary of Basic Assumptions

3. Population Served by Untreated Ground

Water Systems

4. Pathogens Modeled

5. Microbial Occurrence and

Concentrations

6. Exposure to Potentially Contaminated

Ground Water

7. Pathogenicity

8. Potential Illnesses

10. Request for Comments

F. Conclusion

III. Discussion of Proposed GWR

Requirements

A. Sanitary Surveys

1. Overview and Purpose

2. General Accounting Office Sanitary

Survey Investigation

3. ASDWA/EPA Guidance on Sanitary

Surveys

4. Other Studies

5. Proposed Requirements

6. Reporting and Record Keeping

Requirements

7. Request for Comments

B. Hydrogeologic Sensitivity Assessment

1. Overview and Purpose

2. Hydrogeologic Sensitivity

3. Hydrogeologic Barrier

4. Alternative Approaches to

Hydrogeologic Sensitivity Assessment

5. Proposed Requirements

6. Request for Comments

C. Cross Connection Control

D. Source Water Monitoring

1. Overview and Purpose

2. Indicators of Fecal Contamination

3. Proposed Requirements

4. Analytical Methods

5. Request for Comments

E. Treatment Techniques for Systems with

Fecally Contaminated Source Water or

Uncorrected Significant Deficiencies

1. Overview and Purpose

2. Proposed Requirements

3. Public Notification

4. Request for Comments

IV. Implementation

V. Economic Analysis (Health Risk

Reduction and Cost Analysis)

A. Overview

B. Quantifiable and Non-Quantifiable Costs

1. Total Annual Costs

2. System Costs

3. State costs

4. Non-Quantifiable Costs

C. Quantifiable and Non-Quantifiable Health

and Non-Health Related Benefits

1. Quantifiable Health Benefits

2. Non-quantifiable Health and Non-Health

Related Benefits

D. Incremental Costs and Benefits

E. Impacts on Households

F. Cost Savings from Simultaneous

Reduction of Co-Occurring Contaminants

G. Risk Increases From Other Contaminants

H. Other Factors: Uncertainty in Risk,

Benefits, and Cost Estimates

I. Benefit Cost Determination

J. Request for Comment

1. NTNC and TNC Flow Estimates

2. Mixed Systems

VI. Other Requirements

A. Regulatory Flexibility Act (RFA)

1. Background

2. Use of Alternative Definition

3. Initial Regulatory Flexibility Analysis

4. Small Entity Outreach and Small

Business Advocacy Review Panel

B. Paperwork Reduction Act

C. Unfunded Mandates Reform Act

1. Summary of UMRA Requirements

2. Written Statement for Rules With

Federal Mandates of $100 Million or

More

3. Impacts on Small Governments

D. National Technology Transfer and

Advancement Act

1. Microbial Monitoring Methods

E. Executive Order 12866: Regulatory

Planning and Review

F. Executive Order 12898: Environmental

Justice

G. Executive Order 13045: Protection of

Children from Environmental Health

Risks and Safety Risks

1. Risk of Viral Illness to Children and

Pregnant Women

2. Full Analysis of the Microbial Risk

Assessment

H. Consultations with the Science Advisory

Board, National Drinking Water Avisory

Council, and the Secretary of Health and

Human Services

I. Executive Orders on Federalism

J. Executive Order 13084: Consultation and

Coordination With Indian Tribal

Governments

K. Plain Language

VII. Public Comment Procedures

A. Deadlines for Comment

B. Where to Send Comment

C. Guidelines for Commenting

VIII. References

I. Introduction and Background

The purpose of this section is to

provide background on existing

regulations that affect ground water

systems and current state practices.

A. Statutory Authority

This section discusses the Safe

Drinking Water Act (SDWA)

requirements which EPA must meet in

developing the Ground Water Rule

(GWR).

EPA has the responsibility to develop

a GWR which not only specifies the

appropriate use of disinfection but, just

as important, addresses other

components of ground water systems to

ensure public health protection. Section

1412(b)(8) states that EPA develop

regulations specifying the use of

disinfectants for ground water systems

‘‘as necessary.’’ Under these provisions,

EPA has the responsibility to develop a

ground water rule which specifies the

appropriate use of disinfection, and, in

addition, addresses other components of

ground water systems to ensure public

health protection.

B. Existing Regulations

This section briefly describes the

existing regulations that apply to ground

water systems. These rules are the

baseline for developing the GWR. The

regulations that will be discussed

include the Total Coliform Rule

(TCR)(US EPA, 1989a), Surface Water

Treatment Rule (SWTR)(US EPA,

1989b), Interim Enhanced Surface Water

Treatment Rule (IESWTR)(US EPA

1998d), Information Collection Rule

(ICR)(US EPA, 1996b), Stage 1

Disinfectant/Disinfection Byproducts

Rule (Stage 1 DBPR)(US EPA, 1998e),

Underground Injection Control Program

(US EPA, 1999g) and the Source Water

Assessment and Protection Program/

Wellhead Protection Program.

30196 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

1. Total Coliform Rule

The Total Coliform Rule (TCR),

promulgated on June 29, 1989 (54 FR

27544)(US EPA,1989a) covers all public

water systems. The rule protects public

water supplies from disease-causing

organisms (pathogens), and it is the

most important regulation applicable to

drinking water from ground water

systems.

Total coliforms are a group of closely

related bacteria that are generally freeliving in the environment, but are also

normally present in water contaminated

with human and animal feces. They

generally do not cause disease (there are

some exceptions). Specifically,

coliforms are used as a screen for fecal

contamination, as well as to determine

the efficiency of treatment and the

integrity of the water distribution

system. The presence of total coliforms

in drinking water indicates that the

system is either fecally contaminated or

vulnerable to fecal contamination.

The TCR requires systems to monitor

their distribution system for total

coliforms at a frequency that depends

upon the number of people served and

whether the system is a community

water system (CWS) or non-community

water system (NCWS). The monitoring

frequency ranges from 480 samples per

month for the largest systems to once

annually for some of the smallest

systems. If a system has a total coliformpositive sample, it must (1) test that

sample for the presence of fecal coliform

or E. coli, (2) collect three repeat

samples (four, if the system collects one

routine sample or fewer per month)

within 24 hours and analyze them for

total coliforms (and then fecal coliform

or E. coli, if positive), and (3) collect at

least five routine samples in the next

month of sampling regardless of system

size.

Under the TCR, a system that collects

40 or more samples per month

(generally systems that serve more than

33,000 people) violates the maximum

contaminant level (MCL) for total

coliforms if more than 5.0% of the

samples (routine + repeat) it collects per

month are total coliform-positive. A

system that collects fewer than 40

samples per month violates the MCL if

two samples (routine or repeat samples)

during the month are total coliformpositive. For any size system, if two

consecutive total coliform-positive

samples occur at a site during a month,

and one is also fecal coliform/E. colipositive, the system has an acute

violation of the MCL, and must provide

public notification immediately. The

presence of fecal coliforms or E. coli

indicates that recent fecal

contamination is present in the drinking

water.

The TCR also requires a sanitary

survey every five years (ten years for a

protected, disinfected, ground water

system) for every system that takes

fewer than five samples per month (the

monitoring frequency for systems

serving 4,100 people or fewer, which is

approximately 97% of GWS). Other

provisions of the TCR include criteria

for invalidating a positive or negative

sample and a sample siting plan to

ensure that all parts of the distribution

system are monitored over time.

2. Surface Water Treatment Rule and

Interim Enhanced Surface Water

Treatment Rule

The Surface Water Treatment Rule,

promulgated in June 29, 1989 (54 FR

27486)(40 CFR Part 141, Subpart H)(US

EPA 1989b), covers all systems that use

surface water or ground water under the

direct influence of surface water. It is

intended to protect against exposure to

Giardia lamblia, viruses, and Legionella,

as well as many other pathogens. The

rule requires all such systems to reduce

the level of Giardia by 99.9% (3-log

reduction) and viruses by 99.99% (4-log

reduction). Under this rule, all surface

water systems must disinfect. The vast

majority must also filter, unless they

meet certain EPA-specified filter

avoidance criteria that define high

source water quality. More specifically,

the SWTR requires: (1) A 0.2 mg/L

disinfectant residual entering the

distribution system, (2) maintenance of

a detectable disinfectant residual in all

parts of the distribution system; (3)

compliance with a combined filter

effluent performance standard for

turbidity (i.e., for rapid granular filters,

5 nephelometric turbidity units (NTU)

maximum; 0.5 NTU maximum for 95%

of measurements (taken every 4 hours)

during a month); and 4) watershed

protection and other requirements for

unfiltered systems. The SWTR set a

maximum contaminant level goal

(MCLG) of zero for Giardia, viruses, and

Legionella. The MCLG is a nonenforceable level based only on health

effects.

On December 16, 1998, EPA

promulgated the Interim Enhanced

Surface Water Treatment Rule (IESWTR)

(63 FR 69478)(US EPA, 1998d). The

IESWTR covers all systems that use

surface water, or ground water under

the direct influence of surface water,

that serve 10,000 people or greater. Key

provisions include: a 2-log

Cryptosporidium removal requirement

for filtered systems; strengthened

combined filter effluent turbidity

performance standards (1 NTU

maximum; 0.3 NTU maximum for 95%

of measurements during a month);

individual filter turbidity provisions;

disinfection benchmark provisions to

ensure continued levels of microbial

protection while facilities take the

necessary steps to comply with new

disinfection byproduct (DBP) standards;

inclusion of Cryptosporidium in the

definition of ground water under the

direct influence of surface water and in

the watershed control requirements for

unfiltered public water systems;

requirements for covers on new finished

water reservoirs; sanitary surveys for all

surface water systems regardless of size;

and an MCLG of zero for

Cryptosporidium. In a parallel

rulemaking, EPA has proposed a

companion microbial regulation for

surface water systems serving less than

10,000 people, the Long Term 1

Enhanced Surface Water Treatment

Rule.

3. Information Collection Rule

The Information Collection Rule,

promulgated on May 14, 1996 (61 FR

24368)(40 CFR part 141, Subpart M)(US

EPA, 1996b), is a monitoring and data

reporting rule. The data and information

provided by this rule will support

development of the Stage 2 Disinfection

Byproducts Rule and a related microbial

rule, the Long Term 2 Enhanced SWTR,

scheduled for promulgation in May

2002.

The ICR applied to large water

systems serving at least 100,000 people,

and ground water systems serving at

least 50,000 people. About 300 systems

operating 500 treatment plants were

involved. The ICR required systems to

collect source water samples, and in

some cases finished water samples,

monthly for 18 months, and test them

for Giardia, Cryptosporidium, viruses,

total coliforms, and either fecal

coliforms or E. coli. The ICR also

required systems to determine the

concentrations of a range of disinfectant

and disinfection byproducts in different

parts of the system. These disinfection

byproducts form when disinfectants

used for pathogen control react with

naturally occurring total organic

compounds (TOC) already present in

source water. Some of these byproducts

are toxic or carcinogenic. The rule also

required systems to provide specified

operating and engineering data to EPA.

The required 18 months of monitoring

under the ICR ended in December 1998.

As noted earlier, the only ground

water systems affected by the ICR were

those that served at least 50,000 people.

These systems had to conduct treatment

study applicability monitoring (by

measuring TOC levels) and, in some

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30197

cases, studies to assess the effectiveness

of granular activated carbon or

membranes to remove DBP precursors.

In addition, ground water systems

serving at least 100,000 people had to

obtain disinfectant and DBP occurrence

and treatment data. EPA is still

processing the ICR data, and has not

used this information in developing the

GWR.

4. Stage 1 Disinfectants/Disinfection

Byproducts Rule

The Stage 1 Disinfectants/Disinfection

Byproducts Rule (Stage 1 DBPR) (63 FR

69389; December 16, 1998) (US EPA,

1998e) sets maximum residual

disinfection level limits for chlorine,

chloramines, and chlorine dioxide, and

MCLs for chlorite, bromate, and two

groups of disinfection byproducts: total

trihalomethanes (TTHMs) and

haloacetic acids (HAA5). TTHMs

consist of the sum of chloroform,

bromodichloromethane,

dibromochloromethane, and

bromoform. HAA5 consist of the sum of

mono-, di-, and trichloroacetic acids,

and mono- and dibromoacetic acids.

The rule requires water systems that use

surface water or ground water to remove

specified percentages of organic

materials, measured as total organic

carbon (TOC), that may react with

disinfectants to form DBPs. Under the

rule, precursor removal will be achieved

through a treatment technique

(enhanced coagulation or enhanced

softening) unless a system meets

alternative criteria.

The Stage 1 DBPR applies to all CWSs

and non-transient NCWSs, both surface

water systems and ground water

systems, that treat their water with a

chemical disinfectant for either primary

or residual treatment. In addition,

certain requirements for chlorine

dioxide apply to transient water

systems.

A ground water system that disinfects

with chlorine or other chemical

disinfectant must comply with the Stage

1 DBPR by December 2003. Sampling

frequency will depend upon the number

of people served. Ground water systems

not under the direct influence of surface

water that serve 10,000 people or greater

must take one sample per quarter per

treatment plant, and analyze for TTHMs

and HAA5; systems that serve fewer

than 10,000 people must take one

sample per year per treatment plant

during the month of warmest water

temperature, and analyze for the same

chemicals. Systems must monitor for

chlorine or chloramines at the same

location and time that they monitor for

total coliforms. Additional monitoring

for other chemicals is required for

systems that use ozone or chlorine

dioxide.

5. Underground Injection Control

Program

In 1980, EPA established an

Underground Injection Control (UIC)

Program (US EPA, 1999g) to prevent

injection practices which contaminate

sources of drinking water. The UIC

Program protects both underground

sources of drinking water and ground

water under the direct influence of

surface water, which includes at least 41

percent of the streams and rivers in the

U.S. during dry periods. Injection is a

common and long-standing method of

placing fluids underground for disposal,

storage, replenishment of ground water,

enhanced recovery of oil and gas, and

mineral recovery. These fluids often

contain contaminants. The EPA sets

minimum requirements for effective

State programs to ensure that injection

practices, or ‘‘injection wells’’ as they

are called in the UIC Program, are

operated safely. EPA or the appropriate

State regulatory agency may impose on

any injection well, requirements for

siting, construction, corrective action,

operation, maintenance, monitoring,

reporting, plugging and abandonment,

and impose penalties on violators. The

UIC Program regulations are designed to

recognize varying geologic, hydrologic

or historic conditions among different

States or areas within a State.

The UIC Program regulations are

found under Title 40 of the Code of

Federal Regulations (CFR), Parts 124,

and 144–148. Section 144.6 divides

injection practices into five categories or

classes of wells. Classes I, II, and III are

wells which inject fluids beneath and

away from aquifers used by ground

water systems into confined geologic

formations. These wells are associated

with municipal or industrial waste

disposal, hazardous waste or radioactive

waste sites, oil and gas production, and

extraction of minerals. Class IV and

most of Class V are wells which inject

contaminants, into or above aquifers

which may be used by ground water

systems. Class IV wells inject hazardous

or highly radioactive wastes and are

banned by all States and EPA. Class V

wells include storm water and

agricultural drainage wells, dry wells,

floor drains and similar types of shallow

disposal systems which discharge

directly or indirectly to ground water,

but in any case, must not endanger the

ground water resources. However, Class

V wells which may pose the greatest

potential threat to ground water systems

include poorly-designed or

malfunctioning large-capacity septic

tanks, leach fields and cesspools

associated with solely sanitary

wastewater disposal. Malfunctioning

septic systems can result in the release

of disease-causing microorganisms

including enteric viral and bacterial

pathogens to surface and ground water.

Multi-family, commercial,

manufacturing, recreational, and

municipal facilities, particularly those

located in unsewered areas sometimes

dispose both sanitary waste and process

wastewater containing harmful

chemicals in Class V wells. This

combination can increase the risk of

contamination to aquifers used by

ground water systems. Approximately

half of the States have adopted primary

enforcement authority for the regulation

in whole or part and, therefore, have

primary enforcement responsibility

(primacy). State enforcement activities

range from notices of improper activities

to penalties and well closures. For those

States which do not have primacy, the

EPA Regional Offices perform the

enforcement duties. (Note: the UIC

Program does not regulate individual or

single family residential septic systems

and cesspools which inject solely

sanitary wastewater) (40 CFR

144.1(g)(1)(2)). EPA has finalized

banning large capacity cesspools in

ground water source water protection

areas (64 FR 234, December 7,

1999)(USEPA, 1999g).

6. Source Water Assessment and

Protection Program (SWAPP) and the

Wellhead Protection (WHP) Program

The Wellhead Protection Program

(WHP Program) in SDWA section 1428

requires every State to develop a

program that protects ground water

sources of public drinking water. The

intended result of the WHP Program are

local pollution prevention programs that

reduce or eliminate the threats of

contamination to ground water sources

of drinking water. To do this, States

delineate wellhead protection areas

(WHPA) in which sources of

contamination are managed to minimize

ground water contamination. WHPA

boundaries are determined based on

factors such as well pumping rates,

time-of-travel of ground water flowing

to the well, aquifer boundaries, and

degree of aquifer protection by the

overlying geology. These hydrogeologic

characteristics have a direct effect on

the likelihood and extent of

contamination. Currently, 48 States and

two territories have a WHP Program in

place.

A new Source Water Assessment and

Protection Program (SWAPP) was

incorporated into SDWA section 1453

and requires each State to establish a

SWAPP that describes how the State

will: (1) Delineate source water

30198 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

protection areas; (2) inventory

significant contaminants in these areas;

and (3) determine the susceptibility of

each public water supply to

contamination. This program builds

upon the WHP Program; however, it

addresses both ground water and

surface water sources of public drinking

water. The States’ SWAPP were

approved by EPA by November, 1999.

Under the SWAPP, the State must

complete source water assessments for

all PWSs by November 6, 2001,

although EPA may grant an extension to

May 6, 2003. A summary of the results

of the source water assessments must

then be made available to the public in

CWSs’ Consumer Confidence Reports.

The 1996 Amendments to the SDWA do

not require States to protect water

sources after the assessments are

completed.

EPA seeks, in today’s proposed GWR,

to incorporate the States’ SWAPP and

WHP Programs into an overall Agency

program for protecting ground water

sources of public drinking water by

encouraging States to use information

gathered through these programs in sitespecific sanitary surveys and

hydrogeologic sensitivity assessments

where appropriate.

C. Industry Profile—Baseline

Information

1. Definitions and Data Sources

Outlined in the following section are

data sources relied upon by the Agency

to develop baseline information for the

GWR. The baseline information is

important to understanding how various

regulatory options might affect risk

reduction and the cost to small public

water systems. The information shows

that there is a large number of systems

which solely utilize ground water, over

156,000. In addition, most of the ground

water systems are small, with 97%

serving 3,300 or fewer people. However,

55% of the people served by ground

water sources get their drinking water

from systems which serve 10,000 or

more persons (one percent of the

systems).

A public water system (PWS) is one

that serves 25 or more people or has 15

or more service connections and

operates at least 60 days per year. The

following discussion of PWSs is based

on the current definition of PWS (i.e.,

operating at least 60 days a year). A

PWS can be publicly owned or privately

owned. EPA classifies PWSs as

community water systems (CWSs) or

non-community water systems

(NCWSs). CWSs are those that serve at

least 15 service connections used by

year-round residents or regularly serves

at least 25 year-round residents. NCWSs

do not have year-round residents, but

serve at least 15 service connections

used by travelers or intermittent users

for at least 60 days each year, or serving

an average of 25 individuals for at least

60 days a year. NCWSs are further

classified as either transient or nontransient. A non-transient noncommunity water system (NTNCWS)

serves at least 25 of the same persons

over six months per year (e.g., factories

and schools with their own water

source). Transient non-community

water systems (TNCWS) do not serve at

least 25 of the same persons over six

months per year (e.g., many restaurants,

rest stops, parks). The majority of

ground water systems are NCWSs, with

60% (93,618) transient and 12%

(19,322) non-transient. CWSs make up

the remaining 28% (44,910) of all

ground water systems. Although there

are far more NCWSs, CWSs serve a far

larger number of people.

Over 88 million people are served by

CWSs that use ground water and 20

million people are served by NCWSs

that use ground water. An overlap

occurs because most people are served

by both types of systems which may

also include a combination of ground

and surface water. For example, a

person may be served by a surface water

community water system (CWS) at

home and by a ground water noncommunity water system (NCWS) at

work.

EPA uses two primary sources of

information to characterize the universe

of ground water systems: the Safe

Drinking Water Information System

(SDWIS) and the Community Water

System Survey (CWSS) (US EPA,

1997c). EPA’s SDWIS contains data on

all PWSs as reported by States and EPA

Regions. This data reflects both

mandatory and optional reporting

components. States must report the

location of the system, system type

(CWS, TNCWS, or NTNCWS), primary

raw water source (ground water, surface

water or ground water under the direct

influence of surface water), and

violations. States may also report, at

their option, type of treatment and

ownership type. EPA does not have

complete data on the discretionary

items (such as treatment) in SDWIS for

every system; this is especially common

for NCWSs.

The second source of information,

CWSS, is a detailed survey of surface

and ground water CWSs conducted by

EPA in 1995 (US EPA, 1997c). The

CWSS includes information such as the

number of system operators, revenues,

expenses, treatment practices, source

water protection measures, and capacity

(i.e., the amount of water the system is

designed to deliver). The CWSS

contains data from 1,980 water systems,

and is stratified to represent CWSs

across the U.S. Of the 1,980 water

systems that were surveyed by CWSS,

1,020 are ground water systems; 510 are

surface water systems; and 450

represent purchased water systems.

Among the ground water systems

represented, approximately 17% were

from systems serving 100 persons or

less; 20% were from systems serving

101–500 persons; 13% were from

systems serving 501–1,000 persons;

14% were from systems serving 1,001–

3,300 persons; 15% were from systems

serving 3,301–10,000 persons; 10%

were from systems serving 10,001–

50,000 persons; and 11% were from

systems serving 50,001 or more persons.

Baseline profile data for ground water

systems from SDWIS and CWSS are

summarized later. The data on system

ownership, treatment, and operator

information is from the CWSS.

2. Alternate Definition of ‘‘Public Water

System’’ and the Problem of Short-Term

Water Providers

EPA is not today proposing to change

the definition of ‘‘public water supply,’’

nor proposing additional requirements

for short-term water providers. If EPA

decides to take either action, EPA will

publish a proposal at a later date.

However, EPA requests comment on the

following issues.

A PWS is one that serves 25 or more

people or has 15 or more service

connections and operates at least 60

days per year. EPA requests comment

on the definition of ‘‘public water

system’’ specifically, shortening the

time period within the regulatory

definition (§ 141.2). Section 1401(4)(A)

of the SDWA defines public water

system as one that ‘‘regularly serves at

least twenty-five individuals.’’ EPA by

regulation defined the minimum time

period that a system ‘‘regularly’’ serves

as 60 days. See 40 FR 59566, December

24, 1975 for a discussion of the

definition. The current definition

applies after a minimum of 1,500

consumer servings (60 days multiplied

by 25 individuals). However, some

drinking water providers serve far more

people during just a few events. For

example, out-door public events may

occur at a site just a few days a year but

may draw thousands of people to each

event. Such drinking water providers

thus can affect the public health of a

similar number of persons in a short

period of time as a system that serves

fewer people for a longer period. EPA

wants to provide the same public health

protection in these situations. Only

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30199

contaminants that cause adverse health

effects through small volumes or short

exposure (e.g., acute contaminants such

as microbes, nitrate and nitrite) are of

concern at these short term events.

Therefore, EPA is considering changing

the definition of ‘‘public water system’’

by reducing the 60 day time frame to 30

days and including events drawing

many people on one or just a few days,

specifically by adding the phrase, ‘‘or

serves at least 750 people for one or

more days’’ to the end of the current

definition of ‘‘public water system.’’ In

other words, for short-term providers,

the term ‘‘regularly serves’’ would be

defined in terms of the number of

persons served rather than days of

service, but the minimum number of

persons served would be equivalent to

the number of servings for longer-term

systems. EPA requests comment on this

issue. Rather than the simple total of

750 (30 days times 25 people), should

EPA include a minimum of persons

served days (calculated by multiplying

the average number of individuals

served by the number of days the system

serves water)? What should that number

be? Should there be a sliding scale (e.g.,

for a system operating one day and

serving more than 10,000 consumers,

and systems operating more than 30

days and serving 2,000 consumers)?

EPA requests comments on defining/

identifying systems, implementation,

public notice, training, monitoring and

record keeping and reporting issues for

these systems if they were included.

As an alternate to changing the

definition EPA is also considering and

requesting comments on requiring

under section 1431 of the SDWA or

other appropriate authorities that

transient water providers or other types

of drinking water systems (including

those not currently defined as public

water systems) monitor for acute

contaminants prior to providing water

to the public and requiring that any

such provider that finds acute

contaminants at a level above the MCL

not be allowed to serve drinking water

until it is corrected. Currently, transient

public water systems must currently

monitor for total coliforms, nitrate and

nitrite. In addition, transient public

water systems using surface water or

ground water under the direct influence

of surface water must comply with the

treatment technique requirements of the

SWTR. EPA is also considering

proposing requiring any noncommunity water system that is not

operated year round monitor for: fecal

coliforms, nitrate and nitrate, and that

monitoring required to show treatment

technique compliance (e.g.,

Cryptosporidium) no more than 30 days

prior to beginning operation for that

season. EPA requests comment on what

time frame the monitoring should be

completed prior to beginning operation

(i.e., 10 or 15 days).

3. Number and Size of Ground Water

Systems

Nationally, SDWIS indicates that

there are approximately157,000 public

water systems that use ground water

solely (SDWIS, 1997). Slightly more

than 13,000 additional systems use

surface water. SDWIS only describes

any system that uses any amount of

surface water as a surface water system.

SDWIS therefore, does not have

information on the number of systems

that mix ground water and surface

water. Under the SDWA and for

purposes of the Regulatory Flexibility

Act (RFA) analysis, EPA defines a small

system as serving fewer than 10,000

people. According to SDWIS (1997),

96.6% of the 42,413 CWSs and virtually

all of the NCWSs that use ground water

serve fewer than 10,000 persons and

thus are ‘‘small.’’ Collectively, 99% of

systems serve fewer than 10,000 people.

About 97% of the systems (152,555)

serve 3,300 people or fewer (totaling

over 31 million people nationally). The

purpose of these requirements would be

to prevent any endangerment to public

health that might occur if these shortterm, high volume providers dispense

drinking water that is untested and

potentially contaminated.

4. Location of Ground Water Systems

Ground water systems are located in

all 50 States, many tribal lands and most

United States territories. The number of

ground water systems varies

substantially by State. The largest

numbers of ground water systems are in

the States of Wisconsin, Michigan,

Pennsylvania, New York and

Minnesota. These five States, each with

over 8,000 ground water systems,

account for over 50,698 ground water

systems—one third of the total number

in the U.S. By contrast, Hawaii (126),

Kentucky (287), Rhode Island (430), and

the United States territories (<254) have

the fewest ground water systems (See

Table I–1).

5. Ownership of Ground Water Systems

For ground water CWSs, 36% are

publicly operated, 35% are owned and

operated by private entities whose

primary business is providing drinking

water, and 29% are ancillary water

systems which are operated by entities

whose primary business is not

providing drinking water, but do so to

support their primary business (e.g.,

mobile home park operators). The

distribution of ownership type,

however, varies significantly with the

size of the system. For example, over

90% of the ground water systems

serving less than 100 people are

privately owned or are ancillary

systems. For systems serving over

100,000 people, only 16% are privately

owned and none are ancillary systems.

TABLE I–1.—NUMBER OF GROUND WATER SYSTEMS AND POPULATIONS SERVED BY STATE AND SYSTEM TYPE

State/territory

CWSs TNCWSs NTNCWSs

Number of

systems

Population

served

Number of

systems

Population

served

Number of

systems

Population

served

Alabama ............................................................... 345 1,283,469 123 11,170 46 21,182

Alaska .................................................................. 511 342,722 906 97,647 0 0

American Samoa ................................................. 10 48,692 0 0 0 0

Arizona ................................................................. 783 1,308,843 602 120,126 216 100,317

Arkansas .............................................................. 480 1,003,145 442 22,521 57 13,528

California .............................................................. 2,831 14,223,977 3,698 1,301,671 1,018 359,096

Colorado ............................................................... 548 927,917 1,061 153,454 133 34,884

Commonwealth of the Northern Marianas ........... 30 50,769 7 620 6 3,039

Connecticut .......................................................... 537 311,771 3,360 2,980,181 641 121,664

Delaware .............................................................. 225 173,460 215 57,634 86 24,840

District of Columbia .............................................. 0 0 0 0 0 0

Florida .................................................................. 2,019 13,132,468 3,660 304,865 1,119 286,055

Georgia ................................................................ 1,465 1,484,860 663 127,661 291 80,240

Guam ................................................................... 6 20,220 0 0 2 770

30200 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

TABLE I–1.—NUMBER OF GROUND WATER SYSTEMS AND POPULATIONS SERVED BY STATE AND SYSTEM TYPE—

Continued

State/territory

CWSs TNCWSs NTNCWSs

Number of

systems

Population

served

Number of

systems

Population

served

Number of

systems

Population

served

Hawaii .................................................................. 109 1,247,315 3 1,125 14 7,437

Idaho .................................................................... 658 579,778 1,033 125,873 265 68,195

Illinois ................................................................... 1,255 2,606,104 3,715 413,000 446 142,655

Indiana ................................................................. 806 1,826,820 2,984 327,229 693 158,102

Iowa ...................................................................... 1,033 1,239,902 639 78,653 133 35,715

Kansas ................................................................. 601 747,169 110 4,481 67 23,602

Kentucky .............................................................. 124 271,630 83 9,374 80 21,620

Louisiana .............................................................. 1,211 2,707,805 482 115,804 234 88,070

Maryland .............................................................. 448 519,289 2,509 93,757 495 142,171

Massachusetts ..................................................... 360 1,396,430 863 209,476 229 67,650

Michigan ............................................................... 1,185 1,602,792 8,930 1,187,331 1,718 344,654

Minnesota ............................................................. 919 2,074,843 6,963 252,602 672 49,514

Mississippi ............................................................ 1,253 2,586,680 169 28,006 126 89,416

Missouri ................................................................ 1,194 1,638,152 1,040 138,894 227 76,360

Montana ............................................................... 554 267,597 1,011 140,745 215 38,504

Nebraska .............................................................. 616 811,112 584 22,241 189 26,219

Nevada ................................................................. 250 187,509 273 55,792 91 28,497

New Hampshire ................................................... 621 262,371 1,012 181,949 421 77,505

New Jersey .......................................................... 516 2,339,500 2,955 346,484 1,009 274,758

New Mexico ......................................................... 600 1,235,920 506 74,256 149 38,101

New York ............................................................. 1,940 4,396,557 5,742 853,533 693 248,223

North Carolina ...................................................... 1,900 1,271,804 5,373 542,400 655 198,136

North Dakota ........................................................ 258 239,874 215 16,910 22 2,349

Ohio ...................................................................... 1,129 3,555,876 3,545 533,921 1,116 276,441

Oklahoma ............................................................. 556 671,287 302 34,172 123 20,419

Oregon ................................................................. 677 622,157 1,390 233,477 332 67,531

Pennsylvania ........................................................ 1,788 1,567,696 7,017 922,336 1,251 480,328

Puerto Rico .......................................................... 207 623,958 4 765 43 36,426

Rhode Island ........................................................ 59 127,854 300 48,875 71 25,246

South Carolina ..................................................... 550 671,878 577 54,837 248 71,239

South Dakota ....................................................... 367 250,742 243 42,949 25 3,072

Tennessee ........................................................... 193 1,312,996 503 61,504 58 11,010

Texas ................................................................... 3,613 6,150,001 1,378 245,171 748 253,468

Tribes ................................................................... 685 330,466 0 0 82 20,833

Utah ...................................................................... 335 583,506 439 79,371 52 20,969

U.S. Virgin Islands ............................................... 0 0 0 0 0 0

Vermont ................................................................ 346 154,521 718 523,079 1 25

Virginia ................................................................. 1,199 584,779 1,911 443,920 772 312,422

Washington .......................................................... 2,092 2,299,340 1,498 283,735 287 70,009

West Virginia ........................................................ 297 304,888 644 47,313 182 39,318

Wisconsin ............................................................. 1,117 1,947,016 9,704 731,781 1,049 214,561

D. Effectiveness of Various Best

Management Practices in Ground Water

Systems

There are numerous sanitation

practices, called best management

practices (BMPs), to prevent, identify

and correct contamination in a water

supply. These practices relate to well

siting, well construction, distribution

system design and operations. Examples

of BMPs that form a barrier to ground

water contamination include drilling

into a protected aquifer; siting a well

away from sources of contamination;

identifying and controlling

contamination sources; and

disinfection. BMPs that form a barrier to

well contamination include well casing,

well seals, and grouting the well.

Distribution system BMPs include

disinfection; maintaining positive

pressure; flushing water mains; and

adopting cross connection control

programs. Surveillance BMPs such as

sanitary surveys are conducted to

identify weaknesses in the barriers.

EPA recognizes that BMPs can and do

contribute significantly to the safety of

drinking water; however, the

effectiveness of each individual practice

can be difficult to measure. Two studies,

State Ground Water Management

Practices—Which Practices are Linked

to Significantly Lower Rates of Total

Coliform Rule Violations? (US EPA,

1997d) and the Analysis of Best

Management Practices for Community

Ground Water Systems (Association of

State Drinking Water Administrators, or

ASDWA, 1998), were conducted to

examine the relative effectiveness of

BMPs in reducing microbial

contamination of ground water systems.

The EPA study compared BMP

implementation at the State level to

total coliform MCL violation rates of

community ground water systems over

a four year period. The ASDWA study

compared BMP implementation to

detections of both total and fecal

coliform in community ground water

systems over a two year period.

A third study was conducted by EPA,

Ground Water Disinfection and

Protective Practices in the United States,

(US EPA, 1996a) to review State

practices and requirements for the

protection of drinking water that has

ground water as its source.

1. EPA Report on State Ground Water

Management Practices

In the EPA study, State Ground Water

Management Practices—Which

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30201

Practices are Linked to Significantly

Lower Rates of Total Coliform Rule

Violations? (US EPA, 1997d), 12 BMPs

were compared to the MCL violation

rate for total coliform in community

water systems by State. The 12 State

BMPs were taken from the EPA report

Ground Water Disinfection and

Protective Practices in the United States

(US EPA, 1996a). The study used total

coliform MCL violation data in SDWIS

for community water systems for Fiscal

Years 1993 through 1996. In the study,

pairwise and stepwise linear regression

analyses were used to determine if there

was a statistically significant difference

in the TCR MCL violation rates between

those States that practice a particular

BMP and those that do not. From this

perspective, BMPs associated with

lower violation rates are considered

effective. The 12 BMPs included in the

study were well construction codes,

well/pump disinfection requirements,

sanitary surveys, disinfection of new/

repaired mains, cross connection

controls, operator certification,

minimum setback distances, EPA

approved State Wellhead Protection

Programs, periodic flushing of mains,

wellhead monitoring, hydrogeologic

criteria, and disinfection.

Six of the 12 State management

practices were unsuitable for pairwise

analysis because these practices were

present in nearly all States. Therefore, a

comparison of TCR MCL violation rates

in States with and without these

practices could not be made. The BMPs

for which analysis were not done were:

well construction codes, well/pump

disinfection requirements, sanitary

surveys, disinfection of new/required

mains, cross connection controls, and

operator certification. However, these

six management practices were

evaluated as part of the 1998 Best

Management Practices Survey

conducted by ASDWA.

Using a pairwise statistical analysis,

two of the remaining six practices,

disinfection and hydrogeologic criteria,

showed a significant statistical

relationship (at a .01 and a .05 level of

confidence, respectively) in lowering

the statewide median TCR violation

rates, with disinfection showing the

strongest relationship. In this analysis,

disinfection is defined as the

maintenance of at least a chlorine

residual or its equivalent at the entry

point or in the distribution system. The

report focused its analysis on

disinfection practices among 20 States,

comparing the 10 highest disinfecting

States with the 10 lowest disinfection

States. Specifically, the 10 States with

the highest percentage of disinfected

CWSs had an average MCL violation

rate of 16% over the four year period,

versus a 33% violation rate for the ten

States with the lowest disinfection rates.

States that require hydrogeologic criteria

for well siting and construction

decisions had significantly lower

median MCL violation rates than States

that do not use these criteria (15.4% vs.

24.6%). The other four practices,

minimum setback distances from

pollution sources, EPA approved

Wellhead Protection Programs, periodic

flushing of the distribution system, and

wellhead monitoring, did not show a

significant relationship in lowering TCR

violation rates at the State level. The

report does not provide information on

the statistical significance of these

results.

The four year time frame for the

statistical analyses was chosen as a

more accurate reflection of the

effectiveness of statewide management

practices given the high degree of

variability in the TCR violation rate

from year to year. Different trends

emerge when annual rates are

compared. There is not enough data to

determine if the year to year variability,

shown in the FY 96 data, correlates to

a change in State management practices.

In a second analysis, stepwise linear

regression was used on the six best

management practices to further explain

the variability among States in their

reported TCR MCL violation rates. This

analysis examines both the

simultaneous effect of several BMPs on

the State TCR MCL violation rate and

evaluates which of the practices may

explain the variability in the TCR

violation rate among States.

Ascertaining how much of the State-toState variability can be explained by

each of the practices is an important

question given that the TCR

requirements are the same for all States.

The results of this analysis indicate that

disinfection is the single largest factor in

explaining the difference in the TCR

violation rate among States. In general,

the higher the rate of disinfection, the

lower the rate of TCR MCL violations.

Uncertainties associated with this

analysis were: (1) Whether a State’s

BMP requirements are fully

implemented at the system level; (2)

what effect the six State BMPs not

analyzed had on violation rates; (3) the

degree of voluntary implementation of

BMPs; and (4) the effect of not including

State practices required only under

certain circumstances. Nonetheless, this

data on State management practices

indicates that there is a significant

association between disinfection and a

lower TCR MCL violation rate.

2. ASDWA Analysis of BMPs for

Community Ground Water Systems

In the ASDWA study, The Analysis of

Best Management Practices for

Community Ground Water Systems

(ASDWA, 1998), a working group

selected 28 BMPs that represent four

major areas of plant operations and

developed and distributed a survey to

all 50 State drinking water programs.

Each State was asked to select eight

systems in each of the three following

categories: (1) Systems with no

detections of total coliform; (2) systems

with total coliform detections only; and

(3) systems with both total coliform and

fecal coliform (or E. coli) detections. For

each system, the State was asked to

report which of 28 BMPs listed were

used by the system during a two year

period (1995 and 1996). Thirty-six

States responded to the survey, each

completing up to 24 individual system

surveys, providing data for 812 systems.

The survey results were analyzed

using both descriptive statistics and two

statistical models—pairwise and

logistical regression. The descriptive

statistics illustrate the characteristics of

a system but cannot isolate the effect of

a particular BMP from the effects of

other BMPs. The statistical models were

used to describe the relationship

between implementation of individual

or a group of BMPs and a reduction in

total or fecal coliform detections.

A pairwise association analysis (i.e.,

comparing a system that implements a

particular BMP to one that does not)

was used to determine if the use of a

BMP reduced the percentage of positive

total coliform samples. The analysis

determined that a significant association

was found between 21 of the 28 BMPs

and systems with no total coliform

detections. The two BMPs with the

strongest correlation to fewer total

coliform detections were correction of

deficiencies identified by the sanitary

survey and operator certification

(ASDWA, 1998).

Using pairwise analysis for systems

with fecal coliform (based only on those

systems with at least one positive total

coliform sample), the study found a

significant association for eight of the

twenty-eight BMPs. These eight BMPs

include: system wells constructed

according to State regulations, routine

disinfection after well or pump repair,

treatment for purposes other than

disinfection, system maintaining

acceptable pressure at all times, water

distribution tanks are designed

according to State requirements,

systems are in compliance with State

permitting requirements, systems have

corrected deficiencies noted by the State

30202 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

and system and operators receive

routine training and education.

According to the results, fewer BMPs

are found to be significant in this

analysis than the total coliform analysis.

These results are expected given that the

analysis of fecal coliform and E. coli

only evaluate systems with at least one

total coliform positive detection. Fecal

coliform and E. coli tests are more

specific to organisms found in human

and animal feces, whereas total coliform

tests indicate the presence of a broader

class of enteric organisms. For this

reason, there are fewer data points to

model the association of BMPs with

fecal coliform. Therefore, this analysis

sets apart only the BMPs significant in

preventing or eliminating fecal

contamination.

Using the logistical regression

technique, three BMPs were associated

with a significant reduction of total

coliform-positive samples: (1)

Maintaining a disinfectant residual; (2)

operator training; and (3) correcting

deficiencies identified by the State as

part of a sanitary survey. The two BMPs

associated with a significant reduction

of fecal coliform/E. coli-positive

samples were treatment for purposes

other than disinfection, e.g., iron

removal, and operator training. Another

analysis was constructed using Logit

models for four categories of BMPs to

consider the effects of BMPs in groups

rather than individually. Out of the four

categories (Source Protection/

Construction, Treatment, Distribution

System, and Management and

Oversight), the Management and

Oversight category showed the most

significant association with reduced

coliform detections.

The ASDWA survey also evaluated

the effectiveness of BMPs with regard to

system size. For systems serving less

than 500 persons, correction of

deficiencies identified by the State, and

regular training and education of

operators were the most significant in

reducing microbial contamination.

Routine disinfection after well or pump

repair had the greatest significance

among systems serving between 501 and

3,300 persons, while maintaining a

disinfection residual had the greatest

significance among systems serving

between 3301 and 10,000 persons.

Overall, this study found that the

percentage of systems implementing

BMPs is highest among systems with no

total coliform detections. In addition,

systems that routinely educate and train

their operators were more likely to

implement other BMPs than systems

with no regular training. Similarly,

those systems that practice disinfection

(contact time or maintain disinfection

residual) were more likely to implement

other BMPs than systems that do not

disinfect. Observations about the

implementation of BMPs suggests that

many BMPs are interrelated, therefore, it

is difficult to isolate the effect of an

individual BMP.

3. EPA Report on Ground Water

Disinfection and Protective Practices

The purpose of the EPA study,

Ground Water Disinfection and

Protective Practices in the United States,

(US EPA, 1996a) was to compile and

assess State regulations, guidance,

codes, and other materials pertaining to

protection of public health from

microbial contamination in public water

systems using ground water.

The information compiled included

the following:

• Wellhead/ground water protection

information;

• Ground water disinfection

requirements;

• Well siting and construction

requirements/guidelines;

• Sanitary survey requirements/

guidelines;

• Distribution system protection

requirements/guidelines; and

• Operator certification requirements.

The study found that there are

widespread, but diverse requirements

for the protection of drinking water that

has ground water as its source. Few of

these protective practices are used by all

States and there is a variety of

interpretations of the same practice. For

example, 47 States specify minimum

setback distances from sources of

microbial contamination but show a

wide range of setback distances for the

same type of contaminant source; 49

States drinking water programs require

disinfection of some sort, but when and

where disinfection is required varies

considerably; and of the 48 States that

have well construction codes, 21 States

do not require consideration of

hydrogeological criteria in the approval

of the siting of a well.

Overall, the study found that although

many States appear to require similar

BMPs, the nature, scope, and detail of

these requirements varies considerably

at the national level.

E. Outreach Activities

1. Public Meetings

As part of the 1986 amendments to

the Safe Drinking Water Act (SDWA)

Section 1412(b)(8), Congress directed

EPA to promulgate a national primary

drinking water regulation (NPDWR)

requiring disinfection as a treatment

technique for all public water systems,

including those served by surface water

and ground water. In 1987, EPA began

developing a rule to cover ground water

systems. This effort included a

preliminary public meeting on the

issues in 1990 (see 55 FR 21093, May

22, 1990, US EPA, 1990a). In 1992, EPA

circulated a strawman draft for

comment (see 57 FR 33960, July 31,

1992) (US EPA, 1992a).

From 1990 to 1997, EPA conducted

technical discussions on a number of

issues, primarily to establish a

reasonable means of establishing

whether a ground water source was

vulnerable to fecal contamination and

thus pathogens. This effort was

accomplished through 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

addition, technical meetings were held

in Irvine, California in July 1996, (US

EPA, 1996c) and in Austin, Texas in

March 1997 (US EPA, 1997e).

The SDWA was amended in August

1996, and as a result, several statutory

provisions were added establishing new

drinking water requirements.

Specifically, Congress required under

section 1412(b)(8) that EPA develop

regulations specifying the use of

disinfectants for ground water systems

‘‘as necessary.’’ These amendments

established a new regulatory framework

that required EPA to set criteria for

States to determine whether ground

water systems need to disinfect. In

December 1997, EPA held its first of a

series of stakeholder meetings to present

a summary of the findings resulting both

from technical discussions held since

1990 and from information generated by

internal EPA working groups with the

intention of developing disinfection

criteria for ground water systems.

EPA held a preliminary Ground Water

Rule meeting on December 18 and 19,

1997, in Washington, DC for the

purpose of engaging all interested

stakeholders in the analysis of data to

support the GWR. The two day meeting

covered discussions on the implications

of the data, solicited further data from

stakeholders, and reviewed EPA’s next

steps for rule development, data

analysis and stakeholder involvement.

Since December 1997, EPA has held

GWR stakeholder meetings in Portland,

OR, Madison, WI, Dallas, TX, Lincoln,

NE, and Washington, DC along with

three early involvement meetings with

State representatives. In addition, EPA

has received valuable input from small

system operators as part of an Agency

outreach initiative under the Small

Business Regulatory Enforcement

Fairness Act. See section VI for more

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30203

information on the SBREFA process.

Taken together, these stakeholder

meetings have been crucial both in

obtaining feedback and getting

additional information as well as in

guiding the Agency’s consideration and

development of different regulatory

components.

The Agency’s goal in developing the

GWR is to reduce the risk of illness

caused by microbial contamination in

public water systems relying on ground

water. The series of GWR stakeholder

meetings were beneficial in assisting

EPA in understanding how State

strategies fit together as part of a

national strategy. For more information

see the (Stakeholders Meeting

Summary, Resolve, July 27, 1998).

Portland, OR, GWR Stakeholder Meeting

There were four different regulatory

approaches presented in the first of a

series of stakeholder meetings held in

Portland, OR, in May 1998: the Barrier

Assessment Approach, the Existing

State Practices Approach, the Setback

Approach, and the Checklist Approach

(Stakeholder Meetings Summary,

Resolve, July 27, 1998). All approaches

address, to varying degrees, three main

areas: minimum program requirements

or baseline measures, identification of

high risk wells, and corrective action.

Discussions on the potential approaches

centered around determining triggers

that could place a well in a high priority

category and which minimum set of

BMPs should be implemented at high

risk wells.

Madison, WI GWR Stakeholder Meeting

There were three approaches

presented in a June 9, 1998, GWR

stakeholder meeting held in Madison,

WI: Status Quo Approach, Baseline

Approach, and Disinfection Approach.

Regulatory approaches were revised in

response to stakeholder input from the

earlier GWR stakeholder meetings,

representing a continuum of

requirements, from Existing Status Quo

to mandatory disinfection for all ground

water systems. EPA emphasized that

existing occurrence data does not

appear to support mandatory

disinfection across the board, but that

the Agency would still appreciate

stakeholder input on a range of options.

The approaches presented were based

on monitoring, inspections, BMPs and

disinfection.

Dallas, TX GWR Stakeholder Meeting

A third GWR meeting on June 25,

1998 in Dallas, TX, provided slight

modifications to the regulatory

approaches, but for the most part the

regulatory approach remained

unchanged from the Madison meeting

held in early June. EPA continued to

emphasize the need to identify and

strengthen the potential barriers to

contamination. Among the three

approaches, (Status Quo, Progressive

and Universal Disinfection) the

Progressive approach was considered

the more viable regulatory option to

ensure public health protection among

public water systems.

Early Involvement Meetings

ASDWA held three early involvement

meetings (EIMs) on the GWR. The first

EIM followed the May 5, 1998

stakeholder meeting in Portland, OR.

The second EIM meeting was held in

Washington, DC on July 14 and 15, 1998

and the third meeting was held in

Chicago, IL on April 7 and 8, 1999.

Representatives from 12 States, four

EPA Regions, ASDWA and EPA

Headquarters participated in the May 6

and 7, 1998 meeting in Portland, OR.

The second EIM involved 10 State

representatives, ASDWA, and EPA

Headquarters. The third EIM included

one Region, seven State representatives,

ASDWA and EPA Headquarters. The

purpose of the meetings was to review

the findings and comments from the

stakeholder meetings and to work

together to further refine GWR

regulatory options. EPA and States

discussed a range of issues including

risk, exposure, strategies for identifying

high risk systems, occurrence data, and

regulatory implementation barriers.

2. Review and Comment of Preliminary

Draft GWR Preamble

EPA developed a preliminary draft

preamble reflecting a wide range of

input from numerous stakeholders

across the country including four public

meetings, three EIMs with State

representatives, in addition to valuable

input received from small system

operators as part of the outreach process

established by SBREFA.

To facilitate the rule development

process, the preliminary draft preamble

was made available to the public via the

Internet through EPA’s website site on

February 3, 1999. Approximately 300

copies were mailed to participants of

the public meetings or to those who

requested a copy. EPA welcomed any

comments, suggestions, or concerns

reviewers had on either the general

direction or the technical basis of the

proposal. EPA closed the email box on

February 23, 1999 and continued to

receive written comments through the

mail through March 17, 1999. Because

this was an informal process, EPA did

not prepare a formal response to the

comments. Nonetheless, the Agency

carefully reviewed and evaluated all

comments and technical suggestions

and greatly appreciated the input and

feedback provided by these outreach

efforts.

Eighty individual comment letters

were received. Commenters included:

State and local government

representatives, trade associations,

academic institutions, businesses and

other Federal agencies. Microbial

monitoring received the most individual

comments. Sanitary survey, sensitivity

assessment and treatment issues were

next, respectively.

II. Public Health Risk

The purpose of this section is to

discuss the health risk associated with

pathogens in ground waters. More

detailed information about pathogens

may be found in three EPA drinking

water criteria documents for viruses (US

EPA 1985a; 1999b; 1999c), three EPA

criteria documents for bacteria (US EPA

1984a, b; 1985b) and the GWR

Occurrence and Monitoring Document

(US EPA, 1999d). EPA requests

comment on all the information

presented in this section, and the

potential impact of proposed regulatory

provisions on public health risk.

A. Introduction

Enteric viral and bacterial pathogens

are excreted in the feces of infected

individuals. Many bacterial pathogens

can infect both humans and animals.

Bacterial pathogens that infect humans

can also be found in animal feces. In

contrast, enteric viruses that are human

pathogens generally only infect humans,

and thus are only found in human feces.

These organisms are able to survive in

sewage and leachate derived from septic

tanks (septage) and sewer lines. When

sewage and septage are released into the

environment, they are a source of fecal

contamination. Fecal contamination is a

very general term that includes all of the

organisms found in feces, both

pathogenic and non-pathogenic, as well

as chemicals.

Fecal contamination of ground water

can occur by several routes. First, fecal

contamination can reach the ground

water source from failed septic systems,

leaking sewer lines, and from land

discharge by passage through soils and

fissures. Twenty-five million

households in the United States use

conventional onsite wastewater

treatment systems, according to the

1990 Census. These systems include

systems with septic systems and leach

fields. A national estimate for failure

rates of these systems is not available;

however, a National Small Flows

Clearinghouse survey reports that in

30204 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

1993 alone, 90,632 failures were

reported. (USEPA, 1997f). 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.

Third, fecal contamination may also

enter the distribution system when cross

connection controls fail or when

negative pressure in a leaking pipe

allows contaminant infiltration.

Biofilms in distribution systems may

harbor bacterial pathogens, especially

the opportunistic pathogens that cause

illness primarily in individuals with

weakened immune systems. These

bacterial pathogens may have entered

the distribution system as part of fecal

matter from humans or other animals.

Biofilms may also harbor viral

pathogens (Quignon et al., 1997), but,

unlike some bacterial pathogens, viruses

do not grow in the biofilm. However, a

biofilm may protect the viruses against

disinfectants and help them survive

longer.

Although not the basis for today’s

proposed rule, there are additional

waterborne pathogens that EPA is

currently evaluating. These include

bacterial pathogens that may be freeliving in the environment, and thus not

necessarily associated with fecal

contamination. These pathogens include

Legionella (causes Legionnaires Disease

and Pontiac Fever), Pseudomonas

aeruginosa, and Mycobacterium aviumintracellulare. Many of these bacteria

can colonize pipes of the distribution

system and plumbing systems and may

play a role in causing waterborne

disease that is currently under study.

EPA recognizes the potential risk of

such organisms, but believes that more

research needs to be conducted before

they can be considered for regulation.

Also, the Agency is aware that Giardia

and Cryptosporidium have occurred in

ground water systems (GWSs) (Hancock

et al., 1998), causing outbreaks in such

systems (Solo-Gabriele and Neumeister,

1996). However, by definition under

§ 141.2 ground waters with significant

occurrence of large diameter pathogens

such as Giardia or Cryptosporidium are

considered ground water under the

direct influence of surface water and are

already subject to the SWTR and

IESWTR. The Agency is also not

addressing in the GWR the important

issue of toxic or carcinogenic chemicals

in the GWR. This issue is instead

covered in other regulations that

address chemicals.

In order to assess the public health

risk associated with drinking ground

water, EPA has evaluated information

and conducted analysis in a number of

important areas discussed in more detail

later. These include: (1) Recent

waterborne disease outbreak data; (2)

dose-response data and other health

effects data from a range of pathogens;

(3) occurrence data from ground water

studies and surveys; (4) an assessment

of the current baseline ground water

protection provided by existing

regulations; and (5) an analysis of risk.

B. Waterborne Disease Outbreak Data

The purpose of this section is to

present a detailed review of waterborne

disease outbreaks associated with

ground waters. Outbreak

characterization is useful for indicating

relative degrees of risk associated with

different types of source water and

systems.

The Centers for Disease Control and

Prevention (CDC) maintains a database

of information on waterborne disease

outbreaks in the United States. The

database is based upon responses to a

voluntary and confidential survey form

that is completed by State and local

public health officials. CDC defines a

waterborne disease outbreak as

occurring when at least two persons

experience a similar illness after

ingesting a specific drinking water

(Kramer et al., 1996). Data from the CDC

database appears in Tables II–1, II–2, II–

3, and II–4.

The National Research Council

strongly suggests that the number of

identified and reported outbreaks in the

CDC database (both for surface and

ground waters) represents a small

percentage of actual waterborne disease

outbreaks (Safe Water From Every Tap,

National Research Council, 1997;

Bennett et al., 1987; Hopkins et. al.,

1985 for Colorado data). In practice,

most waterborne outbreaks in

community water systems are not

recognized until a sizable proportion of

the population is ill (Perz et al., 1998;

Craun 1996), perhaps 1% to 2% of the

population (Craun, 1996). Some of the

reasons for the lack of recognition and

reporting of outbreaks, most of which

were noted by the National Research

Council (1997), are as follows:

• Some States do not have active

disease surveillance systems. Thus,

States that report the most outbreaks

may not be those in which the most

outbreaks occur.

• Even in States with effective disease

surveillance systems, health officials

may not recognize the occurrence of

small outbreaks. In cities, large

outbreaks are more likely to be

recognized than sporadic cases or small

outbreaks in which ill persons may

consult different physicians. Even so,

health authorities did not recognize the

massive outbreak (403,000 illnesses) of

waterborne cryptosporidiosis that

occurred in Milwaukee, WI, in 1993,

until the disease incidence was near or

at its peak (MacKenzie et al., 1994). The

outbreak was recognized when a

pharmacist noticed that the sale of overthe-counter diarrheal medicine was very

high and consequently notified health

authorities.

• Most cases of waterborne disease

are characterized by general symptoms

(diarrhea, vomiting, etc.) that cannot be

distinguished from other sources (e.g.,

food).

• Only a small fraction of people who

develop diarrheal illness seek medical

assistance.

• Many public health care providers

may not have sufficient information to

request the appropriate clinical test.

• If a clinical test is ordered, the

patient must comply, a laboratory must

be available and proficient, and a

positive result must be reported in a

timely manner to the health agency.

• Not all outbreaks are effectively

investigated. Outbreaks are included in

the CDC database only if water quality

and/or epidemiological data are

collected to document that drinking

water was the route of disease

transmission. Monitoring after the

recognition of an outbreak may be too

late in detecting intermittent or a onetime contamination event.

• Some States do not always report

identified waterborne disease outbreaks

to the CDC. Reporting outbreaks is

voluntary.

• The vast majority of ground water

systems are non-community water

systems (NCWSs). Outbreaks associated

with NCWSs are less likely to be

recognized than those in community

water systems because NCWSs generally

serve nonresidential areas and transient

populations.

There is also the issue of endemic

waterborne disease. Endemic

waterborne disease may be defined as

any waterborne disease not associated

with an outbreak. A more precise

definition is the normal level of

waterborne disease in a community.

Under this definition, an outbreak

would represent a spike in the

incidence of disease. Based on this

definition, the level of endemic

waterborne disease in a community may

be quite high. For example, 14%-40% of

the normal gastrointestinal illness in a

community in Quebec was associated

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30205

with drinking treated water from a

surface water source (Payment et al.,

1997). Significant levels of endemic

disease could also be associated with

ground waters. Because endemic

waterborne disease may be a significant

and substantially preventable source of

health risk, under the directive of the

1996 SDWA Amendments, EPA is

jointly pursuing with CDC a multi-city

study of waterborne disease occurrence

in an effort to provide greater

understanding of this risk. EPA believes

that some meaningful percentage of the

nationwide occurrence of endemic

waterborne disease is in ground water

systems (GWSs). EPA believes that the

prudent policy of prevention embodied

in this proposal with regard to

identified sources of substantial

microbial risk to GWSs gains further

justification as a counter to the endemic

occurrence of waterborne disease. EPA

solicits comment and any data that can

increase knowledge of these endemic

risks, in particular any studies on such

risk in GWSs.

CDC Waterborne Disease Outbreak Data

Outbreak data collected by CDC are

presented in Tables II–1, II–2 , II–3, and

II–4. Table II–1 provides outbreak data

for all public water systems (surface and

ground water). Table II–2 shows sources

of waterborne disease outbreaks for

GWSs. Table II–3 identifies the etiology

of waterborne outbreaks in GWSs. Table

II–4 shows causes associated with

waterborne disease outbreaks and

illnesses in GWSs.

According to CDC, between 1971 and

1996 a total of 643 outbreaks and

571,161 cases of illnesses were reported

(see Table II–1); however, the total

includes 403,000 cases from a single

surface water outbreak caused by

Cryptosporidium in Milwaukee, WI in

1993. Excluding the Milwaukee

outbreak from the data set, 642

outbreaks and 168,161 cases of illness

were reported during the same period of

time. Ground water sources were

associated with 371 (58%) of the total

outbreaks and 16% of the associated

illness (54% of the illness if the

Milwaukee outbreak is excluded). In

comparison, surface water sources were

associated with 216 (33%) of the total

outbreaks and 82% of the associated

illness (40% of the illness if the

Milwaukee outbreak is excluded).

Although the data in Table II–1 indicate

that NCWSs using ground water had

twice as many outbreaks as CWSs using

ground water, this may reflect the fact

that there are over twice as many

NCWSs as CWSs.

The outbreak data indicate that the

major deficiency in ground water

systems was source water

contamination—either untreated or

inadequately treated ground water (see

Table II–2). Contaminated source water

was the cause of 86% of the outbreaks

in ground water systems. Contamination

due to source water was the cause of

68% of the outbreaks for CWSs, while

for NCWSs it was 92%. Distribution

system deficiencies were associated

with 29% of the outbreaks in CWSs and

in five percent of the NCWSs.

Of the 371 outbreaks in ground water

systems, 91 (25%) were associated with

specific viral or bacterial pathogens,

while 22 (6%) were associated with

chemicals (see Table II–3). Etiologic

agents were not identified in 232 (63%)

outbreaks. The diversity of disease

agents is similar to that of surface water,

with a variety of protozoa, viruses, and

bacteria. As stated previously, a ground

water with Cryptosporidium or Giardia

is, by definition, a ‘‘ground water under

the direct influence of surface water’’,

and is thus subject to the microbial

treatment requirements of a surface

water system (i.e., SWTR or IESWTR).

According to CDC’s data, bacterial

pathogens were responsible for more

outbreaks (57) than were viral pathogens

(34). However, EPA suspects that many,

perhaps a majority, of the outbreaks

where an agent was not determined

(232) were virus-caused, given the fact

that it is generally more difficult to

analyze for viral pathogens than

bacterial pathogens. The fecal bacterial

pathogen, Shigella, caused far more

reported outbreaks (eight percent) than

any other single agent.

Table II–4 shows outbreak data since

1991, the year in which the TCR became

effective. Untreated ground water and

inadequate treatment were collectively

associated with 73% of the outbreaks in

ground water systems between 1991–

1996.

Large outbreaks are rarely associated

with ground water systems because

most ground water systems are small.

However, one large outbreak occurred in

Georgetown, TX, in 1980 (Hejkal et al.,

1982) where 7,900 people became ill.

Coxsackievirus and hepatitis A virus

were found in the raw well water in a

karst hydrogeologic setting; the outbreak

was the result of source water

contamination. Another occurred in

1965, in Riverside, CA, where about

16,000 illnesses resulted from exposure

to Salmonella typhimurium in the

source water (Boring, 1971).

Most of the outbreaks were caused by

agents of gastrointestinal illness.

Normally, the disease is self-limiting

and the patient is well within one week

or less. However, in some cases, deaths

have occurred. In 1989, four deaths (243

illnesses) occurred in Cabool, MO, as a

result of distribution system

contamination by E. coli 0157:H7

(Swerdlow et al., 1992; Geldreich et al.,

1992). In 1993, seven deaths (650

illnesses) occurred in Gideon, MO, as a

result of distribution system

contamination by Salmonella

typhimurium (Angulo, 1997). Both cases

involved ground water systems.

Waterborne disease in ground water

systems has also caused serious illness

such as hemolytic uremic syndrome (six

reported cases in two outbreaks), which

includes kidney failure, especially in

children and the elderly. Two cases of

hemolytic uremic syndrome were

reported during the Cabool outbreak, the

affected individuals being three and 79

years of age. Deep wells are not immune

from contamination; for example, an

outbreak of gastroenteritis caused by the

Norwalk virus (900 illnesses) was

associated with a 600-foot well (Lawson

et al., 1991).

Collectively, the data indicate that

outbreaks in ground water systems are

a problem and that source

contamination and inadequate treatment

(or treatment failures) are responsible

for the great majority of outbreaks. The

outbreaks are caused by a variety of

pathogens, most of which cause short

term gastrointestinal disease.

TABLE II–1.—COMPARISON OF OUTBREAKS AND OUTBREAK-RELATED ILLNESSES FROM GROUND WATER AND SURFACE

WATER FOR THE PERIOD 1971–1996 1 2

Water source Total outbreaks1 Cases of

illnesses

Outbreaks in

CWSs

Outbreaks in

NCWSs Total CWS4 Total NCWS4

Ground ............................................ 371 (58%) 90,815 (16%) 113 258 43,908 112,940

Surface ........................................... 216 (33%) 469,7212 (82%) 142 43 10,760 2,848

Other ............................................... 56 (9%) 10,625 (2%) 29 19 ........................ ........................

30206 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

TABLE II–1.—COMPARISON OF OUTBREAKS AND OUTBREAK-RELATED ILLNESSES FROM GROUND WATER AND SURFACE

WATER FOR THE PERIOD 1971–1996 1 2—Continued

Water source Total outbreaks1 Cases of

illnesses

Outbreaks in

CWSs

Outbreaks in

NCWSs Total CWS4 Total NCWS4

All Systems3 ................................... 643 (100%) 571,161 (100%) 284 320 54,668 115,788

1 Modified from Craun and Calderon, 1994, plus 1995–1996 data.

2 Includes 403,000 cases of illness from a single outbreak in Milwaukee, Wisconsin, 1993.

3 Includes outbreaks in CWSs + NCWSs + Private wells.

4Safe Drinking Water Information System, 1998.

TABLE II–2.—SOURCES OF WATERBORNE DISEASE OUTBREAKS, PUBLIC GROUND WATER SYSTEMS, 1971–1996 1,2.

Type of contamination Total Percent of

total CWSs Percent oftotal NCWSs Percent oftotal

Source ............................................... 274 86 53 68 221 92

Untreated .......................................... 150 47 20 26 130 54

Disinfected ........................................ 122 38 31 40 91 38

Filtered .............................................. 2 1 2 3 0 0

Distribution System .................................. 35 11 23 29 12 5

Unknown Cause ....................................... 9 3 2 3 7 3

Total .................................................. 318 100 78 100 240 100

1Source water could not be identified for 29 CWSs and 19 NCWSs with outbreaks, and thus these systems are not included in the table. 2Excludes outbreaks caused by protozoa and chemicals.

TABLE II–3.—ETIOLOGY OF OUTBREAKS IN GROUND WATER SYSTEMS, 1971–96, CWSS AND NCWSS

Causative agent Outbreaks Percent

Undetermined ...................................................................................................................................................................... 232 63

Chemical ............................................................................................................................................................................. 22 6

Giardia ................................................................................................................................................................................. 1 21 6

Cryptosporidium .................................................................................................................................................................. 1 4 1

E. histolytica ........................................................................................................................................................................ 1 <1

Total Protozoa ..................................................................................................................................................................... 26 7

Hepatitis A ........................................................................................................................................................................... 18 5

Norwalk Agent ..................................................................................................................................................................... 16 5

Total Virus ........................................................................................................................................................................... 34 9

Shigella ............................................................................................................................................................................... 30 8

Campylobacter .................................................................................................................................................................... 10 3

Salmonella, non-typhoid ..................................................................................................................................................... 10 3

E. coli .................................................................................................................................................................................. 4 1

S. typhi ................................................................................................................................................................................ 1 <1

Yersinia ............................................................................................................................................................................... 1 <1

Plesiomonas shigelloides .................................................................................................................................................... 1 <1

Total Bacteria ...................................................................................................................................................................... 57 15

Total .................................................................................................................................................................................... 371 100

1Ground waters with Giardia and Cryptosporidium are regulated under the SWTR and IESWTR. These systems would likely not be considered

ground water systems for purposes of this rule.

TABLE II–4.—CAUSES OF OUTBREAKS IN GROUND WATER SYSTEMS, 1991–1996

Cause Number of

outbreaks

Cases of

illness

Percent of outbreak-related

illnesses

Untreated Ground Water ............................................................................................................. 18 2924 51

Distribution System Deficiency .................................................................................................... 6 944 17

Treatment Deficiency ................................................................................................................... 17 1260 22

Miscellaneous, Unknown Cause ................................................................................................. 3 568 10

Total ...................................................................................................................................... 44 5696 100

1Excludes protozoa and chemicals.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30207

C. Ground Water Occurrence Studies

The purpose of this section is to

present data on the occurrence of

waterborne pathogens and indicators of

fecal contamination in ground water

supplying PWS wells. These data are

important to GWR development because

they provide insight on: (1) The extent

to which ground water may be

contaminated; (2) possible fecal

indicators for source water monitoring

under the GWR; and (3) a national

estimate of ground water pathogen

occurrence. In addition, determining the

occurrence of microbial contaminants in

ground water sources of drinking water

is necessary to yield a quantified

national estimate of public health risk.

EPA has reviewed data from13 recent

or on-going studies of pathogen and/or

fecal indicator occurrence in ground

waters that supply PWSs. While most of

these studies were not designed to yield

a nationally representative sample of

ground water systems, one of the studies

(Abbaszadegan et al., 1999, or the

‘‘AWWARF study’’) was later expanded

to include a nationally representative

range of hydrogeologic settings. This

study was used as the basis of EPA’s

quantitative assessment of baseline risk

from viral contamination of ground

water, which is also a component of the

quantitative benefits assessment for the

proposed rule. Short narratives on each

of the studies are provided in the next

sections. The study design and results

for each study are summarized in Table

II–6, at the end of the narratives. The

Agency decided not to combine the data

from these studies, because of the

different method protocols and scopes.

Each occurrence study investigated a

combination of different pathogenic

and/or indicator viruses and bacteria.

Indicator viruses and bacteria may be

non-pathogenic but are associated with

fecal contamination and are transmitted

through the same pathways as

pathogenic viruses and bacteria. The

samples analyzed in each study were

tested for viral pathogens such as

enteroviruses (a group of human viruses

also referred to as ‘‘total cultureable

viruses’’) and/or bacterial pathogens

such as Legionella and Aeromonas.

Several studies used the polymerase

chain reaction (PCR) as part of the

method for determining the presence of

pathogenic viruses. Bacterial indicators

of fecal contamination tested included

enterococci (or fecal streptococci, which

are closely related), and fecal coliforms

(or E. coli, which is closely related), and

Clostridium perfringens. Most studies

tested for total coliforms, which are not

considered a direct fecal indicator since

they also include coliforms that live in

soil. Viral indicators of fecal

contamination were all bacteriophage,

which are viruses that infect bacteria.

Among the bacteriophage tested were

somatic coliphage and/or male-specific

coliphage, both of which infect the

bacterium E. coli. Bacteroides phage

were tested in two studies and

Salmonella phage in one study.

While this section presents a

summary of each study, a more detailed

explanation of one study (Abbaszadegan

et al., 1999) (AWWARF Study) is

provided, as it is the broadest study in

scope. The hydrogeology of individual

wells is mentioned in addition to the

microbial results, because EPA

considers hydrogeology an important

factor in source water contamination.

Hydrogeology is discussed in greater

detail in section III.B.

1. Abbaszadegan et al. (1999)

(AWWARF Study)

Of the 13 studies, the AWWARF

study sampled the largest number of

wells, examined the widest array of well

and system characteristics, and tested

sites in 35 States across the U.S., located

in hydrogeologic settings representative

of national hydrogeology. The objectives

of the AWWARF study were to: (1)

Determine the occurrence of virus

contamination in source water of public

ground water systems; (2) investigate

water quality parameters and

occurrence of microbial indicators in

ground water and possible correlation

with human viruses; and (3) develop a

statistically-based screening method to

identify wells at risk of fecal

contamination. A summary of

AWWARF results are presented in

Tables II–5 and II–6.

Many of the initial sites were selected

to evaluate the effectiveness of a method

based on the reverse-transcriptase,

polymerase chain reaction (RT–PCR)

technique to detect pathogenic viruses

in ground water. Sites for this portion of

the study were selected based on the

following criteria: (1) Ground water sites

with high concentrations of minerals,

metals, or TOC; (2) sites with a previous

detection of any virus or bacteria in the

ground water source; (3) sites with

potential exposure to contaminants due

to agricultural activities near the well,

industrial activities near the well, or

septic tanks near the well; and (4) sites

with different pH values, temperatures,

depths, production capacities and

aquifer types. Sites were selected for the

virus occurrence project based upon

their geological characteristics to

balance out the range of geologies so

that the sites in aggregate more closely

matched the national geologic profile of

ground water sources. Sites for the virus

occurrence study were selected from an

initial mailing to 500 utilities that

currently disinfect their water; 160

utilities with 750 wells volunteered to

be included in the study. In total, 448

wells were sampled for the study.

AWWARF excluded sites from the

investigation if: (1) It was known to be

under the influence of surface water; (2)

the well log records were not available;

or (3) it was considered poorly

constructed.

EPA subsequently compared nitrate

concentrations from a national database

of nitrate concentrations in ground

water (Lanfear, 1992) with nitrate data

measured in the AWWARF study wells.

The purpose of the comparison was to

determine if there was any statistically

significant difference between the

nitrate levels in the AWWARF wells as

compared with the national distribution

of nitrate concentration data. Nitrate

was chosen for this comparison because

there is a large, national database

available. Each data set contained 216

samples selected so that

proportionately, wells of equal depth

were analyzed in each comparison. The

national data were selected randomly

from a database of more than 100,000

wells; all available AWWARF data were

used. In analyzing the data, EPA noted

that the national data is biased by

multiple sampling of many shallow

monitoring wells in farming regions

leading to a few wells having

exceptionally high nitrate levels. In

order to minimize the impact of these

wells on the analysis, EPA chose a small

random subset comparable in size to the

sample in the AWWARF study. Thus,

the data are not directly comparable

with PWS wells. Census data were used

to divide the national nitrate database

into urban and rural components. The

analysis showed that the AWWARF

wells had nitrate concentrations that

were not significantly different from the

national data or from the urban and

rural components. Thus, using nitrate

concentration as a surrogate, EPA

concludes that, by this measure, the

AWWARF wells are nationally

representative.

All samples were collected by the

systems. AWWARF provided a sample

kit containing all needed equipment and

a video illustrating the details of

appropriate sampling and storage

procedures. A total of 539 samples were

collected from 448 sites in 35 States.

The preliminary results indicate that of

the 448 wells sampled, about 64% were

located in unconsolidated aquifers, 27%

in consolidated aquifers including

consolidated sedimentary strata, and

9% in unknown geology.

Unconsolidated aquifers are made of

30208 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

loosely packed (uncemented) particles,

such as sand grains or gravel, while

consolidated aquifers are comprised of

compacted (cemented) particles or

crystalline rock (e.g., granite, limestone).

As discussed further in section III.B.,

the degree and type of consolidation

may affect the transport of pathogens

from a source of fecal contamination to

the well. The percentages of sites

sampled from these geologic settings are

similar to those of national ground

water production from unconsolidated

and consolidated hydrogeologic settings

(modified by AWWARF, from United

States Geological Survey (USGS)

Circular 1081, 1990). The data indicate

that 174 sites (39%) were within 150

feet of a known sewage source, and an

additional 127 sites (28%) were within

550 feet of a known sewage source.

There is no comparable data on the

distribution nationally of wells relative

to sewage sources. EPA notes however,

that the proximity to these sources is

not inconsistent with State standards

across the country. For example, 41

States have setback distances (the

minimum distance between a source of

contamination and a well) that are less

than or equal to 100 feet for sources of

microbial contaminants. Only five

States appear to require setback from all

sewage sources of more than 200 feet.

The preliminary results also indicated

that a total of 25 sites were sampled

more than once. Most sites were from

systems that serve greater than 3,300

people, and almost all systems maintain

a disinfectant residual.

In the study, systems collected at least

400 gallons (1,512 liters) of water and

concentrated it using a filter-adsorption

and elution method. The concentrated

samples were then sent to the

researchers for analysis. The presence of

enteroviruses was determined by two

procedures: a cell culture assay and a

procedure using the RT–PCR technique.

The RT–PCR technique was also used to

determine the presence of hepatitis A

virus, rotavirus, and Norwalk virus. The

researchers also tested each well for

total coliforms, enterococci, Clostridium

perfringens, somatic coliphage, and

male-specific coliphage to establish

their relationship with enterovirus and

to get a better indication of the

percentage of fecally contaminated

wells.

Preliminary results indicated that

fecal contamination occurs in a subset

of PWS wells (see Table II–5). The

investigators detected pathogenic

viruses, either by cell culture or RT–

PCR analyses, in a significant

percentage of samples.

TABLE II–5.—PRELIMINARY RESULTS OF AWWARF STUDY

Assay

Percent of wells

positive (number

positive/samples

analyzed)

Enteroviruses (cell culture) ............................................................................................................................................................. 4.8% (21/442)

Bacterial Indicators ......................................................................................................................................................................... 15.1%

Total coliforms ......................................................................................................................................................................... 9.9% (44/445)

enterococci ............................................................................................................................................................................... 8.7% (31/355)

Clostridium perfringen spores .................................................................................................................................................. 1.8% (1/57)

Coliphage Indicators ....................................................................................................................................................................... 20.7%

Male-specific coliphage (Salmonella WG–49 host) ................................................................................................................. 9.5% (42/440)

Somatic coliphage (E. coli C host) .......................................................................................................................................... 4.1% (18/444)

Somatic and male-specific coliphage (E. coli C–3000 host) ................................................................................................... 10.8% (48/444)

PCR ................................................................................................................................................................................................. 31.5%

Norwalk viruses (PCR) ............................................................................................................................................................ 0.96% (3/312)

Enteroviruses (PCR) ................................................................................................................................................................ 15.9% (68/427)

Rotaviruses (PCR) ................................................................................................................................................................... 14.6% (62/425)

Hepatitis A viruses (PCR) ........................................................................................................................................................ 7.2% (31/429)

2. Lieberman et al., (1994, 1999) (EPA/

AWWARF Study)

The study objectives included the

following: (1) develop and evaluate a

molecular biology (PCR) monitoring

method; (2) obtain occurrence data for

human enteric viruses and Legionella (a

bacterial pathogen) in ground water; and

(3) assess the microbial indicators of

fecal contamination. These objectives

were accomplished by sampling

vulnerable wells nominated by States to

confirm the presence of fecal indicators

(Phase I) and then choosing a subset of

these for monthly sampling for one year

(Phase II).

In Phase I, well vulnerability was

established using historical microbial

occurrence data and waterborne disease

outbreak history, known sources of

human fecal contamination in close

proximity to the well, and sensitive

hydrogeologic features (e.g., karst).

Ninety-six of the 180 potentially

vulnerable wells were selected for

additional consideration. Selected wells

were located in 22 States and 2 US

territories. Additional water quality

information was then successfully

obtained for 94 of the wells through use

of a single one liter grab sample which

was subsequently tested for several

microbial indicators (see Table II–6).

The wells from Phase I served as the

well selection pool for Phase II

sampling.

In Phase II, 23 of the Phase I wells

were selected for monthly sampling for

one year. Seven additional wells were

selected from a list of state-nominated

wells for a total of 30 wells, located in

17 States and 2 US territories. The

additional seven wells were based on

other criteria, including historical water

quality data, known contaminant

sources in proximity to the well,

hydrogeologic character or to replace

wells that were no longer available for

sampling. Samples were analyzed for

enteroviruses, Legionella, enterococci,

E. coli, Clostridium perfringens, total

coliforms, somatic coliphage, malespecific coliphage and Bacteroides

phage. For each sample analyzed for

enteric viruses and bacteriophages, an

average of approximately 6,000 liters of

water were filtered and analyzed by cell

culture.

Twenty samples from seven wells

were enterovirus positive and were

speciated by serotyping. Coxsackievirus

and echovirus, as well as reovirus, were

identified. The range in virus

concentration in enterovirus-positive

samples was 0.9–212 MPN/100 liters

(MPN, or most probable number, is an

estimate of concentration).

The hydrogeologic settings for the

seven enterovirus-positive wells were

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30209

karst (3), a gravel aquifer (1), fractured

bedrock (2), and a sandy soil and

alluvial aquifer (1). The karst wells were

all positive more than once. The gravel

aquifer was also enterovirus-positive

more than once, with 4 of 12 monthly

samples positive.

3. Missouri Ozark Aquifer Study #1

The purpose of this study was to

determine the water quality in recently

constructed community public water

system wells in the Ozark Plateau region

of Missouri. This largely rural region is

characterized by carbonate aquifers,

both confined and unconfined, with

numerous karst features throughout. A

confining layer is defined in this study

as a layer of material that is not very

permeable to ground water flow and

that overlays an aquifer and acts to

prevent water movement into the

aquifer.

The US Geological Survey, working

with the Missouri Department of

Natural Resources, selected a total of

109 wells, in both unconfined and

confined aquifers (Davis and Witt, 1998,

1999). In order to eliminate poorly

constructed wells from the study, most

of the selected wells had been

constructed within the last 15 years.

Wells were also selected to obtain good

coverage of the aquifer and to reflect the

variability in land use. All wells were

sampled twice, in summer and winter.

Evidence of fecal contamination was

found in a number of wells. Thirteen

wells had samples that were PCRpositive for enterovirus.

4. Missouri Ozark Aquifer Study #2

The purpose of this study is to

determine the water quality in older

(pre-1970) CWS wells in the Ozark

Plateau region of Missouri to

supplement the Missouri Ozark Aquifer

Study #1, by Davis and Witt (1998,

1999). This largely rural region is

characterized by carbonate aquifers,

both confined and unconfined, with

numerous karst features throughout.

The US Geological Survey, working

with the Missouri Department of

Natural Resources, sampled a total of

106 wells (Femmer, 1999), in both

unconfined and confined aquifers.

Wells (all of which were constructed

before 1970) were selected for

monitoring to obtain good coverage of

the aquifer, and to reflect the variability

in land use. Priority was given to wells

that had completion records, well

operation and maintenance history and

wells currently being used. Each well

was sampled once (during the spring).

No wells were enterovirus-positive by

cell culture.

5. Missouri Alluvial Aquifer Study

The purpose of this study was to

determine water quality in wells located

in areas that were subjected to recent

flooding. The wells are located

primarily in the thick, wide alluvium of

the Missouri and Mississippi rivers.

Sampling (117 samples) occurred during

the period of March through June 1996.

Twelve wells served as control wells

(uncontaminated) and were sited in

‘‘deep rock’’ aquifers or upland areas. A

total of 64 wells were sampled.

Many of the wells had been flooded.

Fifty-five were affected by a flood in

1995. In addition, some of the wells

sampled had been flooded around the

surface well casing prior to the sampling

event, and several were flooded at the

time of sampling (Vaughn, 1996).

6. Wisconsin Migrant Worker Camp

Study

The purpose of this study was to

determine the quality of drinking water

in the 21 public ground water systems

serving migrant worker camps in

Wisconsin (US EPA, 1998a). These

transient, non-community water

systems are located in three geographic

locations across the State. Each well was

sampled monthly for six months, from

May through November, 1997. The

study conducted sampling for malespecific coliphage, total coliforms and E.

coli. When detections of coliforms

occurred, the specific type of coliform

was further identified (speciated). One

total coliform positive sample was

identified to contain Klebsiella

pneumoniae. Along with the microbial

indicators, nitrate and pesticides were

also measured.

Other factors were compared to the

microbial and chemical sampling results

of the study. Well construction records

were available for 14 of the wells. The

mean casing depth was 109 feet (range

40 to 282 feet) and the mean total well

depth was 155 feet (range 44 to 414

feet). Most of these 14 wells are also

reported to terminate in a sand or

sandstone formation.

Investigators detected male-specific

coliphage in 20 of 21 wells during the

six-month sampling period, but never

detected E. coli. In addition, four wells

had nitrate levels that exceeded the EPA

MCL for nitrate.

7. EPA Vulnerability Study

The purpose of this study was to

conduct a pilot test of a new

vulnerability assessment method by

determining whether it could predict

microbial monitoring results (U.S. EPA

1998b). The vulnerability assessment

assigned low or high vulnerability to

wells according to their hydrogeologic

settings, well construction and age, and

distances from contaminant sources. A

total of 30 wells in eight States were

selected to represent ten hydrogeologic

settings. Selection was based on the

following criteria: (1) Wells representing

a variety of conditions relevant to the

vulnerability predictions; (2) wells with

nearby sources of potential fecal

contamination; and (3) wells with

sufficient well and hydrogeologic

information available.

Samples were taken and tested for

enteroviruses (both by cell culture and

PCR), hepatitis A virus (HAV) (by PCR),

rotavirus (by PCR), Norwalk virus (by

PCR), and several indicators (total

coliforms, enterococci, male-specific

coliphage, and somatic coliphage). The

only positive result was one PCR sample

positive for HAV.

8. US-Mexico Border Study

The purpose of this study was to

determine water quality in wells sited in

alluvium along the Rio Grande River

between El Paso, Texas and the New

Mexico border (U.S. EPA, in

preparation). The 17 wells selected were

perceived to be the most vulnerable,

based on well depth, chloride

concentration and proximity to

contamination sources, especially the

Rio Grande River.

The wells tested are relatively shallow

and all serve less than 10,000 people.

One well serves 8,000 people, while

seven wells serve fewer than 100

people. Well depths range from 65 feet

to 261 feet, but most are about 150 feet

deep. This signifies that water was

collected from the middle aquifer, a

shallow but potable aquifer. Wells

shallower than 65 feet contain chloride

concentrations prohibitively high for

drinking water.

Samples were collected from each

well and tested for enteroviruses (by cell

culture), somatic coliphage, and malespecific coliphage. None of the sites

were positive for any of the viruses

tested.

9. Whittier, CA, Coliphage Study

The purpose of this study was to

determine the presence of fecal

contamination in all wells located

within 500 feet down-gradient of a

water recharge infiltration basin (Yanko

et al., 1999). The 23 wells were sampled

once per month for six months.

The wells are sited in similar

hydrogeologic settings, although they

vary in age and depth. The

hydrogeologic setting is primarily a

thick layer of unconsolidated sand, with

lesser amounts of other sized grains.

About 30% of the recharge volume to

30210 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

the wells is reclaimed water. Wells were

all constructed between 1919 and 1989

and produce water from depths ranging

from 60–888 feet.

The wells were sampled monthly for

a six month period. The samples were

tested for total coliforms and indicators

of fecal contamination, including male

specific coliphage, somatic coliphage,

and E. coli. Coliphage were found in all

wells, and repeatedly in 20 of the 23

wells.

10. Oahu, HI Study

The purpose of this study was to

establish a water quality monitoring

program to assess the microbial quality

of deep ground water used to supply

Honolulu (Fujioka and Yoneyama,

1997). A total of 71 wells were sampled,

32 of which were sampled for viruses

and 39 of which were sampled for

bacteria. The wells are located in

carbonate or basalt aquifers.

Each of the wells was tested for

several pathogens and indicators of fecal

contamination. Bacterial samples taken

from 39 wells (79 samples) were tested

for total coliforms, fecal streptococci,

Clostridium perfringens, heterotrophic

bacteria (by m-HPC), and Legionella (by

PCR). Sample volumes were 100 mL for

C. perfringens and heterotrophic

bacteria, and both 100 mL and 500 mL

for coliforms and fecal streptococci. For

FRNA coliphage (male-specific

coliphage), one liter samples from 32

wells (35 samples) were tested by

membrane adsorption-elution method,

while 24 wells (24 samples) were tested

by an enrichment technique developed

by Yanko. None of the wells were

coliphage-positive, and only one sample

each was positive for E. coli and fecal

streptococci.

11. New England Study

The purpose of this study was to: (1)

Determine the prevalence of enteric

pathogens in New England’s public

water supply wells; (2) assess the

vulnerability of different systems; and

(3) evaluate various fecal indicators.

Wells were selected based on the

following criteria: (1) Must have

constant withdrawal throughout the

year; (2) must be near septic systems, (3)

should have, if possible, a history of

violations of the MCL for total coliforms

or elevated nitrate levels; and (4) must

not have direct infiltration by surface

water (Doherty, 1998).

Wells were nominated, characterized,

selected and sampled by regulatory staff

of Connecticut, Maine, Massachusetts,

New Hampshire, Rhode Island, and

Vermont. The selection process

considered wells in different

hydrogeologic settings. Of the 124 total

wells, 69 (56%) were located in

unconfined aquifers, 31 (25%) were

located in bedrock aquifers, 10 (8%)

were located in confined aquifer

hydrogeologic settings, and 14 (11%)

were located in unknown aquifer

settings. Each well was sampled

quarterly for one year. Enterococci were

identified in 20 of 124 wells (16%) and

in 6 of 31 (19%) bedrock aquifer wells.

Two wells were enterovirus-positive

using cell culture methods, both in

unconsolidated aquifers. One of these

two wells is 38 feet deep and the other

well is 60 feet deep. Final results from

this study are not yet available.

12. California Study

The purpose of this research is twofold: (1) To assess the vulnerability of

ground water to viral contamination

through repeated monitoring, and (2) to

assess the potential for bacteria and

coliphages to serve as indicators of the

vulnerability of ground water to viral

contamination (Yates 1999).

Eighteen wells were tested monthly

for human enteroviruses (by cell culture

(direct RT–PCR, Immunomagnetic

separation reverse transcriptase (IMS–

RT–PCR) and integrated cell culture

RT–PCR) and PCR), HAV (by PCR),

rotaviruses (by PCR), somatic and malespecific coliphage, and total coliforms

and fecal streptococci. The depth of the

wells is variable, but is on the order of

about 200 feet (the deeper the well, the

less likely contamination). There are

some intermittent confining layers.

Of the 230 samples tested for

enteroviruses, 6 samples from 6 of the

18 wells were cell culture positive for

enteroviruses. Final results from this

study are not yet available.

13. Three State PWS Study (Wisconsin,

Maryland and Minnesota)

The purpose of the three-state study is

to characterize the extent of viral

contamination in PWS wells by testing

wells in differing hydrogeologic regions

and considering contamination over

time (Battigelli, 1999). Wells were

sampled quarterly for one year in

Wisconsin (25 wells), Minnesota (25

wells), and will be sampled in Maryland

(up to 35 wells).

Three wells in Wisconsin were

positive for enteroviruses by cell

culture. Final results for this study are

not yet available.

TABLE II–6.—GROUND WATER MICROBIAL OCCURRENCE STUDIES/SURVEYS

Study

Number of PWS

wells sampled

and location

Sampling frequency/volume

Indicators monitored (number of

POS. wells/number of wells total,

unless otherwise indicated)

Pathogenic viruses, Legionella

(number of POS. wells/number of

wells total, unless otherwise

indicated)

1. AWWARF

Study.

448 wells; 35

States.

Sampled once (25 wells sampled

twice); 539 samples total, not

all analyses conducted on all

samples. Sampling volumes:

1512L eluated for virus analyses (5 liter equivalent for RT–

PCR, 600L for cell culture),

Coliphage 15L, Bacteria 200

mL.

Male-sp. coliphage, host Salmonella WG–49 (42/440); Somatic coliphage, host E. coli C

(18/444); Coliphage, host E.

coli C–3000 (48/444); Total

coliform (44/445); enterococci

(31/355); C. perfringens (1/57).

Cell Culture: Enterovirus (21/

442); PCR: Rotavirus (62/425),

Hepatitis A virus (31/429), Norwalk virus (3/312), Enterovirus

(68/427).

2a. EPA/

AWWARF

Phase I Study.

94 wells; 22

States plus

PR and USVI.

One sample, 1 L ......................... Somatic coliphage 5/94; 1*; Total

coliform 31/94; 9*; E. coli 18/

94; 5*; enterococci 17/94; 3*;

C. perfringens 4/94; 0*;

*indicates number of wells

positive in Phase I which were

not positive or not sampled in

Phase II.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30211

TABLE II–6.—GROUND WATER MICROBIAL OCCURRENCE STUDIES/SURVEYS—Continued

Study

Number of PWS

wells sampled

and location

Sampling frequency/volume

Indicators monitored (number of

POS. wells/number of wells total,

unless otherwise indicated)

Pathogenic viruses, Legionella

(number of POS. wells/number of

wells total, unless otherwise

indicated)

2b. EPA/

AWWARF—

Phase II Study.

30, of which 23

were from

Phase I; 17

States plus

PR and USVI.

Monthly for one year; Average

volume filtered: 6,037 L; Microscopic Particulate Analysis

(MPA) data available for each

well.

Somatic coliphage (16/30); Male

specific coliphage (6/30);

Bacteroides bacteriophage (6/

30); Somatic Salmonella

bacteriophage (6/30); Total

coliform (24/30); enterococci

(21/30); C. perfringens(10/30);

E. coli (15/30); E. coli H7:O157

(0/7).

Cell Culture: Enterovirus (7/30);

PCR: polio, entero, Hepatitis A,

Norwalk, rota (results not available), (300+ samples from 30

wells; several wells cell culture

positive multiple times);

Legionella sp. (14/30),

Legionella pneumophila (6/30).

3. Missouri Ozark

Plateau Study

#1 (Davis and

Witt, 1999).

109 wells .......... Two samples/well, 25 wells sampled once for tritium, 200–300

L ground water filtered at the

well head.

Somatic coliphage (1/109); Male

specific coliphage (10/109);

Fecal streptococci (1/109);

Fecal coliform (2/109); E. coli

(0/109).

Cell Culture: Enterovirus (0/109);

PCR: Enterovirus (13/109).

4. Missouri Ozark

Plateau Studies

#2 (Femmer,

1999) (pre-1970

wells).

106 wells .......... One sample, 200–300 L filtered

at the well head.

Somatic coliphage (3/106); Male

specific coliphage (3/106);

Fecal streptococci (8/106);

Fecal coliform (8/106); E. coli

(9/106).

Study in progress; Cell Culture:

Enterovirus (0/106).

5. Missouri Alluvial Study.64 wells ............ Sampling occurred during a four

month period. Some sampling

done during flooding.

Somatic coliphage (1/81); Male

specific coliphage (1/81);

Bacteroides bacteriophage (1/

81); Total coliform (33/81);

Fecal coliform (5/81); Fecal

streptococci (12/81).

Cell Culture: Enterovirus (1//81).

6. Wisconsin Migrant Worker

Camp Study.

21 wells ............ Monthly: Bacteria—6 mos.;

Phage—5 mos.; Bacteria—100

mL; Phage—1L.

Male specific coliphage (20/21);

Total coliform (14/21); E. coli

(0/21); K. pneumoniae (1/21).

7. EPA Vulnerability Study.30 wells in 8

States.

Each well visited once. Two 1L

grab samples and 1500–L

sample Equiv. vol. 650L for

enterovirus, 100 mL for bacteria, 10 mL to 100L for

coliphage, PCR?.

Male specific coliphage (0/30);

Somatic coliphage (2/24; large

volume); Total coliform (4/30);

enterococci (0/30).

Cell Culture: enterovirus (0/30);

PCR: HAV (1/30), Rota (0/30),

Norwalk (0/30), enterovirus (0/

30).

8. US-Mexico Border Study (TX

and NM).

17 wells ............ 3 (300–1000 gallon) samples/well Male specific coliphage (0/17);

Somatic coliphage (0/17).

Cell Culture: Enterovirus (0/17).

9. Whittier, CA,

Coliphage

Study.

23 wells ............ Once a month for 6 months; 4L

samples.

Male specific coliphage (18/23);

Somatic coliphage (23/23);

Total coliform (4/23); E. coli (0/

23).

10. Oahu, Hawaii

Study.

Virus—32 wells

Bacteria—39

wells.

Each well sampled 1–4 times;

total 79 samples, Virus—1–L;

C. perfringens, HPC—0.1L;

Coliforms, fecal strep—0.1L

and 0.5L.

Male specific coliphage (0/32);

Somatic coliphage (0/32); Total

Coliform (3/39); E. coli (1/39);

Fecal Streptococci (1/39); C.

perfringens (0/39).

Legionella sp. (PCR; 15/26),

Legionella pneumophila (PCR;

1/27).

11. New England

Study.

124 wells; 6

States.

Each well sampled four times

over one year; Up to 1500–L

sample for virus.

Study in progress; Male specific

coliphage (4/79); Somatic

coliphage (1/70); Total coliform

(27/124); Aeromonas

hydrophila (19/122); C.

perfringens (6/119); E. coli (0/

124); enterococci (20/124).

Study in progress; Cell Culture:

Enterovirus (2/122); PCR:

Enterovirus (results not available).

12. California

Study.

18 wells ............ 14 of 18 wells sampled 12 to 22

times (monthly); Average sample volume 1784 L (range

240–3331 L) 1 l grab sample

for indicators; (Coliphage analyzed using 10 mL grab samples, 1–L enrichment samples,

IMDS filter eluates and filter

concentrates).

Study in progress; Male specific

coliphage: (hosts E. coli

FAMP, S. typhimurium WG–

49) (4/18); Somatic coliphage:

host E. coli 13706 (13/18);

Total coliform (7/18); Fecal

streptococci (0/18).

Study in progress; Cell Culture:

enterovirus (6/18); PCR: HAV

(0/18), Rota (0/18), enterovirus

(direct RT–PCR) (6/18), IMS–

RT–PCR (10/18), Integrated

Cell Culture PCR enterovirus

(4/18)).

13. Three-State

Study (Wisconsin, Maryland, Minnesota).

50 wells (25

from MN, 25

from WI, additional wells

from MD).

Each well sampled four times

over one year.

Study in progress; Somatic

coliphage; Male specific

coliphage; Total coliform;

enterococci; C. perfringens; E.

coli.

Study in progress; Cell Culture:

enterovirus (3/25).

30212 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

D. Health Effects of Waterborne Viral

and Bacterial Pathogens

To assess the public health risk

associated with a waterborne pathogen,

or group of pathogens, both occurrence

data and health effects data are needed.

The previous section discussed the

occurrence in ground water of

pathogens and indicators of fecal

contamination. This section discusses

the health effects associated with

waterborne pathogens, first viral agents

and then bacterial.

Viral Pathogens

Table II–7 and II–8 list viral and

bacterial pathogens that have caused

waterborne disease in ground waters.

Unlike some bacterial pathogens,

viruses cannot reproduce or proliferate

outside a host cell. Viruses that infect

cells lining the human gut are enteric

viruses. With a few exceptions, viruses

that can infect human cells typically

cannot infect the cells of other animals

and vice versa. This contrasts with

many bacterial pathogens, which often

have a broader host range. Some enteric

viral pathogens associated with water

may infect cells in addition to those in

the gut, thereby causing mild or serious

secondary effects such as myocarditis,

conjunctivitis, meningitis or hepatitis.

There is also increasing evidence that

the human body reacts to foreign

invasion by viruses in ways that may

also be detrimental. For example, one

hypothesis for the cause of adult onset

diabetes is that the human body,

responding to coxsackie B5 virus

infection, attacks pancreatic cells in an

auto-immune reaction as a result of

similarities between certain pancreas

cells and the viruses (Solimena and De

Camilli, 1995).

When humans are infected by a virus

that infects gut cells, the virus becomes

capable of reproducing. As a result,

humans shed viruses in stool, typically

for only a short period (weeks to a few

months). Shedding often occurs in the

absence of any signs of clinical illness.

Regardless of whether the virus causes

clinical illness, the viruses being shed

may infect other people directly (by

person-to-person spread, contact with

infected surfaces, etc.) and is referred to

as secondary spread. Waterborne viral

pathogens thus may infect others via a

variety of routes.

TABLE II–7.—SOME ILLNESSES CAUSED BY FECAL VIRAL PATHOGENS

Enteric virus Illness

Poliovirus .................................................................................................. Paralysis.

Coxsackievirus A ...................................................................................... Meningitis, fever, respiratory disease.

Coxsackievirus B ...................................................................................... Myocarditis, congenital heart disease, rash, fever, meningitis, encephalitis, pleurodynia, diabetes melitis, eye infections.

Echovirus .................................................................................................. Meningitis, encephalitis, rash, fever, gastroenteritis.

Norwalk virus and other caliciviruses ....................................................... Gastroenteritis.

Hepatitis A virus ....................................................................................... Hepatitis.

Hepatitis E virus ....................................................................................... Hepatitis.

Small round structured viruses (probably caliciviruses) ........................... Gastroenteritis.

Rotavirus ................................................................................................... Gastroenteritis.

Enteric Adenovirus ................................................................................... Respiratory disease, eye infections, gastroenteritis.

Astrovirus .................................................................................................. Gastroenteritis.

(Data from the 1994 Encyclopedia of Microbiology, Underlineindicates disease causality rather than association)(Lederberg, 1992).

Bacterial Pathogens

Bacterial pathogens may be primary

pathogens (those that can cause illness

in most individuals) or secondary or

opportunistic pathogens (those that

primarily cause illness only in sensitive

sub-populations). Unlike most primary

pathogens, some opportunistic bacterial

pathogens can colonize and grow in the

biofilm in water system distribution

lines. Some waterborne bacterial agents

cause disease by rapid growth and

dissemination (e.g., Salmonella) while

others primarily cause disease via toxin

production (e.g., Shigella, E. coli O157,

Campylobacter jejuni). Campylobacter,

E. coli and Salmonella have a host range

that includes both animals and humans;

Shigella is associated with humans and

some other primates (Geldreich, 1996).

As noted previously, some waterborne

bacterial pathogens can survive a long

time outside their hosts.

Most of the waterborne bacterial

pathogens cause gastrointestinal illness,

but some can cause severe illness too.

For example, Legionella causes

Legionnaires Disease, a form of

pneumonia that has a fatality rate of

about 15%. It can also cause Pontiac

Fever, which is much less severe than

Legionnaires Disease, but causes illness

in almost everyone exposed. A few

strains of E. coli can cause severe

disease, including kidney failure. One

strain, E. coli O157:H7 has caused

several waterborne disease outbreaks

since 1990. It is a prime cause of bloody

diarrhea in infants, and can cause

hemorrhagic colitis (severe abdominal

cramping and bloody diarrhea). In a

small percentage of cases, hemorrhagic

colitis can lead to a life-threatening

complication known as hemolytic

uremic syndrome (HUS), which

involves destruction of red blood cells

and acute kidney failure. From 3% to

5% of HUS cases are fatal (CDC, 1999),

and most commonly found in young

children and the elderly. Some of the

opportunistic pathogens can also cause

a variety of illnesses including

meningitis, septicemia, and pneumonia

(Rusin et al., 1997).

TABLE II–8.—SOME ILLNESSES CAUSED BY MAJOR WATERBORNE BACTERIAL PATHOGENS

Bacterial pathogen Illnesses

Campylobacter jejuni ................................................................................ Gastroenteritis, meningitis, associated with reactive arthritis and

Guillain-Barre paralysis.

Shigella species ........................................................................................ Gastroenteritis, dysentery, hemolytic uremic syndrome, convulsions in

young children, associated with Reiters Disease (reactive arthropathy).

Salmonella species ................................................................................... Gastroenteritis, septicemia, anorexia, arthritis, cholecystitis, meningitis,

pericarditis, pneumonia, typhoid fever.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30213

TABLE II–8.—SOME ILLNESSES CAUSED BY MAJOR WATERBORNE BACTERIAL PATHOGENS—Continued

Bacterial pathogen Illnesses

Vibrio cholerae .......................................................................................... Cholera (dehydration and kidney failure).

Escherichia coli (several species) ............................................................ Gastroenteritis, hemolytic uremic syndrome (kidney failure).

Yersinia entercolitica ................................................................................ Gastroenteritis, acute mesenteric lymphadenitis, joint pain.

Legionella species .................................................................................... Legionnaires Disease, Pontiac Fever

(Data from the 1994 Encyclopedia of Microbiology, Underline indicates disease causality rather than association)(Lederberg, 1992).

E. Risk Estimate

1. Baseline Risk Characterization

This section provides an estimate of

the number of people that may be at risk

of microbial illness associated with

consumption of fecally contaminated

drinking water in populations served by

ground water systems. EPA has

prepared estimates of the numbers of

people at risk of viral illness (and

possibly death) from three conditions in

which fecal contamination may be

introduced to ground water systems:

fecal contamination in the source water

of systems without disinfection; fecal

contamination in the source water of

systems with inadequate (less than 4-log

as discussed later) or failed disinfection;

and fecal contamination of the

distribution system.

The first condition in which EPA

characterizes the baseline risk is for

source contaminated ground water

systems which do not have disinfection

treatment. EPA characterizes the risk to

consumers in these systems in five

steps: (1) Calculating the population

served by undisinfected systems using

ground water sources; (2) determining

the occurrence of the pathogens of

concern in these systems; (3) assessing

the exposure to the pathogens of

concern; (4) determining the

pathogenicity (likelihood of infection)

based on dose-response information for

each of the pathogens characterized; and

(5) calculating the number of illnesses

among the population served resulting

from consumption of water containing

the pathogens.

EPA then estimates additional

illnesses resulting from systems with

inadequate or failed disinfection

treatment and fecally contaminated

source water, and systems in which

fecal contamination is introduced into

the distribution system. These

additional illnesses are estimated based

on the causes of contamination which

lead to waterborne disease outbreaks

reported to the CDC in ground water

systems from 1991 to 1996. To estimate

these additional illnesses, EPA

calculated the ratio of the outbreak

illnesses in systems with inadequate or

failed disinfection treatment to outbreak

illnesses in systems without any

disinfection, and the ratio of outbreak

illnesses in systems with distribution

system contamination to outbreak

illnesses in systems without any

disinfection.

2. Summary of Basic Assumptions

This risk assessment uses a number of

assumptions to arrive at an estimate of

the number of people at risk of illness

or death due to consumption of water

from systems with fecal contamination.

Some of these assumptions are

necessary because data in these areas

simply does not exist.

The feasibility of performing a risk

analysis on each and every microbial

contaminant is diminished when

considering the wide range of different

microbial contaminants that exist, and

that detection methods for all of these

contaminants do not exist. Therefore,

the risk assessment assumes that the

only people exposed to viral

contamination are the people served by

those wells which test positive for the

two viruses used in the risk assessment

model, and the exposed population will

be exposed to the virus concentration

throughout the entire year. The

assumption that the population is

exposed only to viruses which are

accurately described by the model

viruses may lead to an underestimation

of exposure.

The model viruses which were chosen

to act as surrogates for all viruses fall

into two categories; those viruses which

have low-to-moderate infectivity but

relatively severe health effects, and

those viruses which have high

infectivity but relatively mild health

effects. Exposure to viruses that do not

fall into these categories may result in

an underestimate or overestimate of

risk. Risks are not directly quantified for

bacterial contaminants because EPA

does not have sufficient data to directly

model bacterial risk. However, EPA has

adjusted its risk estimate for viral illness

to approximate for the risk of bacterial

illness.

The simplifying assumptions used in

this risk assessment, as well as assessing

the exposure in only the positive wells,

yields an estimated average risk that

EPA assumes is a best estimate of the

actual risk given available data.

3. Population Served by Untreated

Ground Water Systems

EPA estimates there are 44,000

community ground water systems

(CWS) serving 88 million people; 19,000

non-transient, non-community ground

water systems (NTNCWS) serving five

million people; and 93,000 transient

non-community ground water systems

(TNCWS) serving 15 million people

(SDWIS, 1997a). Of these systems, EPA

estimates that 68% percent of CWSs are

disinfected (CWSS, 1997) (US EPA,

1997c). Larger CWSs are more likely to

practice disinfection than are smaller

CWSs (e.g., 81% of CWSs serving more

than 100,000 people are disinfected

while 45% of systems serving less than

100 people disinfect. Estimates of

treatment for noncommunity water

systems are not as detailed. However,

based upon information from State

drinking water programs, EPA estimates

28% of NTNCWS and 18% of TNCWS

disinfect (US EPA, 1996a).

Based upon the number of people

served by ground water systems, and the

percentage of systems which disinfect,

EPA estimates that 18 million people

are served untreated ground water from

CWSs, four million people are served

untreated water from NTNCWSs, and 13

million people are served untreated

water from TNCWSs. There is a

potential for double or triple counting of

the same people within these estimates

since a number of people may be served

ground water from more than one of the

system type categories. For example, a

person may consume water from a CWS

at home, and a NTNCWS at work or a

TNCS while on vacation. EPA has

addressed the potential for double

counting in the analysis by assuming

that individuals do not consume water

from each system type every day (see

section V).

4. Pathogens Modeled

EPA is concerned about ground water

systems which are fecally contaminated

since drinking water in these systems

may contain pathogenic viruses and/or

bacteria. A wide number of viral and

bacterial pathogens have been

associated with waterborne disease in

ground water systems. However, there

are inadequate data for EPA to

30214 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

characterize the risk attributable to each

pathogen because detection methods are

not available for all pathogens.

Additionally, detection methods which

are available may be insensitive and

incapable of detecting the presence of

viruses at very low concentrations.

However, even at low concentrations,

viruses in drinking water can result in

infection. To the extent that detection

methods do not exist for a particular

pathogen, there may be a resultant

underestimation of the risk of illness

and death.

In this analysis, EPA estimates the

number of illnesses annually associated

with two types of pathogenic viruses

found in fecally contaminated ground

water. These two types of viruses are

designated as Type A and Type B

viruses for this analysis. Type A viruses

represent those viruses which are highly

infective, yet have relatively mild

symptoms (e.g., gastroenteritis). For this

analysis, rotavirus is used as a surrogate

for all Type A viruses because rotavirus

has been detected in drinking water

sources, dose-response data have been

prepared for rotavirus and rotavirus has

been implicated as the etiologic agent in

incidents of waterborne disease. Type B

viruses represent those viruses which

have low-to-moderate infectivity, yet

have potentially more severe symptoms

(e.g., myocarditis), and are represented

by echovirus. Echovirus also has

available dose-response data (Regli et al,

1991) and has been implicated in a

waterborne disease outbreak (Haefliger

et al., 1998).

The risk assessment used model

viruses as surrogates of the actual

viruses present. As a result, the risk

assessment provides an estimation of

risks. The additional risks from other

viruses may be higher or lower

depending on their occurrence or

pathogenicity. For example, if the risk

assessment estimated the risks from

exposure to Norwalk virus (a Type A

virus), using rotavirus as a surrogate, the

morbidity rate may be higher for adults

than the rate assumed in the model. An

outbreak in an Arizona resort in 1989

was believed to be caused by a Norwalklike virus. This agent may have been

responsible for an outbreak which

caused illness in 110 out of 240 guests

of all ages (Lawson et al, 1991), a 46%

morbidity rate. This is much higher than

the morbidity rate of 10% for Type A

virus among people older than two.

National occurrence data do not exist

for many of the other pathogens that

may occur in drinking water; therefore,

EPA has limited its estimation of risk to

only those viral pathogens for which

occurrence data and dose response data

are available.

Occurrence studies show a significant

occurrence of bacterial indicators in

ground water wells; for example, almost

9% percent of the wells sampled in the

AWWARF study tested positive for the

presence of enterococci (Abbaszadegan

et al., 1999). However, EPA cannot

directly estimate national illnesses from

bacterial pathogens such as Salmonella,

due to a lack of occurrence data for

those pathogens. EPA believes that the

majority of waterborne illnesses due to

unknown etiological agents are caused

by viruses because viruses move more

readily in the ground, remain viable

longer and are more infectious than

bacteria. Also, more methodologies exist

for the identification of bacterial

pathogens than for viral pathogens and

therefore bacterial pathogens are more

likely to be identifiable. The CDC data

shows that for every 100 viral or

unknown etiological agent illnesses

there were 20 bacterial illnesses.

Therefore, EPA estimates that the

number of viral illnesses can be

increased by 20% to account for

bacterial illnesses in ground water

systems.

5. Microbial Occurrence and

Concentrations

EPA reviewed the ground water viral

occurrence data (see discussion of

occurrence studies in section II. C.) to

develop estimates of: the portion of

ground water sources which are

contaminated with viruses, the period of

time in which the wells are

contaminated, and the concentration of

viruses within the contaminated wells.

EPA believes that improperly

constructed wells may have

significantly higher virus occurrence

and concentrations than properly

constructed wells (wells which do not

comply with State well construction

codes). Improperly constructed wells

are likely to have more pathways for the

introduction of viruses and less natural

filtration by the overlying hydrogeologic

material. Therefore, the exposure and

risks from consumption of water from

improperly constructed wells will most

likely be higher. As a result, the

exposure and risks should be assessed

separately for properly and improperly

constructed wells in order to develop a

range reflecting national conditions.

EPA determined that the study

conducted by AWWARF represents

conditions in properly constructed

wells and the EPA/AWWARF

(Lieberman et al., 1994, 1999) study

represents conditions in improperly

constructed wells. EPA selected the

AWWARF study as representative of

properly constructed wells (e.g., wells

with casing and grout to confining

layers, sanitary seals, etc.) because it

excluded wells of improper

construction and the wells sampled

were representative of hydrogeologic

conditions for water supply wells in the

United States. However, the wells

selected may not have been

representative of the probability of fecal

contamination in ground water wells

nationally. As noted in section II.C.1.,

one-third of the wells in this study were

originally selected for the purpose of

evaluating the effectiveness of the PCR

method based on criteria that may over

represent high risk wells. The remaining

two-thirds were selected to balance the

sample with wells that were

representative of hydrogeologic

conditions for drinking water wells

nationally. EPA requests comment and

data which would help assess the

representativeness of the wells in the

AWWARF study sample. However, EPA

believes that the AWWARF study data

represents the best currently available

data on occurrence of viral pathogens in

properly constructed wells and has thus

used it as the basis of baseline incidence

estimates.

EPA selected the EPA/AWWARF

study to be representative of wells of

improper construction because it

sampled wells which were determined

to be vulnerable to contamination. The

EPA/AWWARF study considered wells

as vulnerable based on one or more of

the following considerations:

hydrogeology, well construction, State

nominations, microbial sampling

results, close proximity to known

sources of fecal contamination, and

water quality history. For the purposes

of the risk assessment, all wells

determined to be vulnerable were used

as surrogates for improperly constructed

wells. The results from this study may

over estimate the risks from improperlyconstructed wells generally, since it

included only wells that were

deliberately selected through a several

step process to be highly vulnerable to

contamination (see section II.C.2.). EPA

estimated that 83% of systems have

properly constructed wells based upon

data from ASDWA’s Survey of Best

Management Practices for Community

Ground Water Systems (ASDWA, 1998).

The AWWARF study data include

viral cell culture assay results which

detect the presence of viable enterovirus

(including echovirus and other Type B

viruses) in the samples. Twenty-one of

the 442 wells sampled (4.8%) tested

positive for the Type B viral cell culture.

EPA determined that this data can be

used to estimate the percentage of

properly constructed wells which are

contaminated at a given point in time

with Type B viruses. The AWWARF

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30215

study data also include rotavirus PCR

results which indicate that 62 of the 425

(14.6%) wells sampled contained

rotavirus genetic material. EPA

determined that the PCR results may be

an overestimation of the portion of wells

with viable Type A viruses since PCR

methods do not distinguish between

viable and non-viable viruses. To

calculate the portion of PCR positive

wells which contain viable viruses EPA

compared the enterovirus (Type B) cell

culture results to the enterovirus (Type

B) PCR analysis and found that for every

enterovirus cell culture positive well,

there were 3.3 PCR enterovirus positive

wells. EPA estimated that the 1/3.3

rotavirus PCR wells contained viable

virus, and therefore 4.4% (14.6%/3.3) of

all properly constructed wells were

contaminated with Type B viruses at

any one time. Viral and bacterial

indicator data indicate there are a

greater percentage of wells in the study

which were fecally contaminated than

contained the viral pathogens at the

time of sampling. For example, almost

16% of all wells tested positive for viral

cell culture, male specific coliphage or

enterococci.

The EPA/AWWARF study sampled

wells vulnerable to contamination

monthly for a one year period and found

that 6.0% of the samples tested positive

for enterovirus (Type B) cell culture.

Since cell culture methods are not

available for rotavirus (the

representative of Type A viruses), the

EPA/AWWARF study tested samples

using PCR methods for the presence of

rotavirus to estimate the occurrence of

Type A viruses in improperly

constructed wells. However, the PCR

data is still under review by researchers

and unavailable for consideration in this

analysis. EPA therefore based the

estimate of occurrence of viable Type A

viruses in improperly constructed wells

on the ratio of viable Type A virus in

the AWWARF study (4.4%) to Type B

viruses in the AWWARF study (4.7%).

Applying this ratio (4.4%/4.7%) to the

percentage of improperly constructed

wells containing Type B viruses (6.0%),

EPA estimates the percentage of

improperly constructed wells with Type

A virus contamination is 5.5%.

EPA estimated Type A and Type B

virus concentrations are 0.36 viruses/

100L for properly constructed wells

based on the mean enterovirus

concentration in the AWWARF study.

EPA also estimated Type A and Type B

virus concentrations to be 29 viruses/

100L for improperly constructed wells

based on the mean enterovirus

concentration in EPA/AWWARF study.

Although these studies determined the

concentrations of enteroviruses (Type B

viruses) only, for the purposes of this

analysis EPA assumed the

concentrations of Type A viruses and

Type B viruses were equivalent.

6. Exposure to Potentially Contaminated

Ground Water

EPA developed estimates of the

population potentially exposed to viral

pathogens based upon the estimates of

population served by undisinfected

systems and the portions of those

systems which are estimated to be

virally contaminated. In CWS, 18

million people are served undisinfected

ground water. Assuming 17% of wells

serving these people are improperly

constructed (and 83% are properly

constructed) from the results of the

ASDWA BMP Survey (ASDWA, 1997),

and Type A viruses occur in 4.4% of

properly constructed wells and 5.5% of

improperly constructed wells, the

population potentially exposed to Type

A viruses in CWS is 842,000. Similar

calculations can be conducted to obtain

the population exposed to Type A

viruses in NTNCWS, as well as Type B

viruses in all ground water systems.

EPA’s estimates of the population

potentially exposed to the viruses are

presented in Table II–9. Many of the

people exposed to the Type A viruses

are also exposed to the Type B viruses,

therefore these number cannot be

added.

TABLE II–9.—POPULATION POTENTIALLY EXPOSED TO VIRALLY CONTAMINATED DRINKING WATER IN

UNDISINFECTED GROUND WATER

SYSTEMS

System

type

Population potentially exposed to type

A virus

Population potentially exposed to type

B virus

CWS ......... 842,000 918,000

NTNCWS .. 175,000 191,000

TNCWS ..... 567,000 619,000

To estimate the risk of illness from

consumption of undisinfected ground

water, EPA estimated people consume

an average 1.2 liters of water per day

based upon the 1994–1996 USDA

Continuing Survey of Food Intakes by

Individuals (US EPA, 2000a). EPA

accounted for the variability in

consumption by modeling consumption

as a custom distribution fit to age groups

in the survey data. EPA also assumed

that people consume water from CWSs

350 days per year; from NTNCWSs 250

days per year; and from TNCWSs 15

days per year. EPA notes that these

assumptions may allow for some double

counting of exposure, but EPA is not

aware of data to allow a more refined

breakdown of consumption. EPA

requests comment on these

assumptions.

7. Pathogenicity

After estimating the population

potentially exposed to untreated (i.e.,

not disinfected) contaminated ground

water and the amount of water

consumed, the next step is to assess the

pathogenicity of the viruses. Once

viruses are consumed, the likelihood of

infection and illness varies depending

on the virus.

For this analysis, the likelihood of

infection from ingestion of one or more

Type A or Type B viruses are estimated

based on dose response equations

developed for rotavirus (Ward et al.,

1986) and echovirus (Schiff et al., 1984),

respectively. These equations estimate

the annual probability of infection

following consumption of a specified

virus and are based on studies of

healthy volunteers. The volunteers for

these studies are typically between the

ages of 20 and 50, and therefore, may

underestimate the probability of

infection in sensitive subpopulations

(e.g., children and elderly) and the

immunocompromised (e.g., nursing

home residents and AIDS patients).

Rotavirus dose-response information

was used to represent Type A viruses,

while echovirus dose-response

information was used to represent Type

B viruses.

Once a person becomes infected, the

likelihood of illness (morbidity) varies,

depending on the pathogen and the

sensitivity of the consumer. For Type A

viruses, EPA assumed the percent of

people becoming ill once infected is

88% for children under the age of two

(Kapikian and Chanock, 1996). EPA

assumed a morbidity rate of 10% for all

other populations based upon a study of

a rotavirus outbreak (Foster et al., 1980)

and incidents of rotavirus in families

with infants ill with rotavirus (Wenman

et al., 1979).

EPA assumed the percent of people

infected with Type B viruses who

become ill also varies with age: 50% for

children five years of age and less, 57%

for individuals between 5 and 16 years

of age, and 33% for people older than

16. EPA estimated these age-specific

morbidity values based on data from a

community-wide echovirus type 30

epidemic (Hall et al., 1970) and from the

New York Viral Watch (Kogon et al.,

1969).

Secondary illnesses result from

individuals being exposed to

individuals who contracted the illness

from drinking water. For this analysis,

EPA estimates the additional number of

30216 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

people who become ill as a result of

secondary spread. For Type A viruses,

EPA assumed that an additional 0.55

people will become ill from every child

that becomes ill through consumption of

drinking water. This assumption is

based on a study of children under five

years old, ill with rotavirus, who spread

the illness to others in their households

(Kapikian and Chanock, 1996). For Type

B viruses EPA assumed that 0.35

additional people will become ill

through secondary spread. This

assumption was based on a review of

various epidemiological studies for

echovirus (Morens et al., 1991). There is

some uncertainty as to the exact rate of

secondary spread for Type B viruses, so

EPA has assumed that the secondary

spread rates range from 0.11 to 0.55.

The probability that an ill person will

die as a result of an illness is referred

to as mortality. EPA expects Type A

viruses to result in far fewer deaths than

Type B viruses. EPA assumed a

mortality rate for all age groups of

0.00073 percent. This assumption was

based on an estimate of 20 rotavirus

deaths per year out of 2,730,000 cases of

rotavirus diarrhea in children 0–4 years

old (Tucker et al., 1998). EPA assumed

the mortality rate for Type B viruses be

0.92 percent for infants one month or

less. This assumption was based upon

studies of hospitalized infants (Kaplan

and Klein, 1983). For the rest of the

population, EPA assumed that 0.04

percent of people ill from Type B

viruses will die. These estimates may

underestimate the number of infant

deaths due to Type B viral illnesses,

since Jenista et al. (1984) and Modlin

(1986) reported a three percent case

fatality rate for infants (one month or

less) which is three times the value used

in the model.

8. Potential Illnesses

EPA estimates, based upon the

assumptions described earlier, that

98,000 viral illnesses each year are

caused by consuming drinking water in

undisinfected public ground water

systems. EPA further estimates that nine

of these people die each year.

EPA believes there are additional

waterborne illnesses and deaths among

consumers of drinking water from

public ground water systems beyond

those estimated due to contaminated

source waters in undisinfected systems.

Between 1991 and 1996 there were

1,260 waterborne outbreak illnesses

reported to CDC which were attributed

to microbial contamination of the source

and inadequate or interrupted

disinfection, and 944 waterborne

illnesses reported to CDC which were

attributed to distribution system

contamination in ground water systems.

In that same period there were 2,924

reported outbreak illnesses in source

contaminated undisinfected system.

This results in 0.43 (1,260/2,924)

additional illnesses in source

contaminated, ground water systems

with failed disinfection for every illness

from undisinfected, fecally

contaminated ground water. Based on

similar analysis, there are also 0.32

(944/2,924) additional illnesses due to

distribution system contamination for

every one illness due to source

contamination in undisinfected ground

water systems. (This ratio does not

apply to transient noncommunity water

systems, because they do not have

distribution systems.) EPA assumed the

ratios of the causes of reported outbreak

illnesses is equal to the ratio of the

causes of all waterborne illnesses.

Therefore, EPA estimates, based upon

these ratios, that an average of 42,000

additional illnesses and four additional

deaths occur each year as a result of

source contamination and inadequate or

interrupted disinfection. EPA also

estimates that an average of 28,000

additional illnesses and three additional

deaths are caused each year by

distribution system contamination.

Table II–10 presents the estimates of

viral illness and death under current

conditions.

TABLE II–10.—ESTIMATES OF BASELINE VIRAL ILLNESS AND DEATH DUE TO CONTAMINATION OF PUBLIC GROUND WATER

SYSTEMS

Cause of contamination No. of type A

virus illnesses

No. of type A

virus deaths

No. of type B

virus illnesses

No. of type B

virus deaths

total illnesses

types A & B

Total deaths

types A & B

Source contamination/undisinfected system ........................................................ 78,000 1 20,000 8 98,000 9

Source contamination/disinfected system 34,000 ........................ 8,000 4 42,000 4

Distribution system contamination ........... 22,000 ........................ 6,000 3 28,000 3

All Causes ......................................... 134,000 1 34,000 14 168,000 16

Because of a lack of occurrence data

for bacterial pathogens in ground water,

risks from bacterial contamination of

ground water sources and distribution

systems are not quantified in this

assessment. Although it is believed that

viruses are more readily transported

through the subsurface than bacteria

(Sinton et al., 1997), ground water

system disease outbreaks caused by

bacterial pathogens such as Shigella,

Salmonella spp., and Campylobacter

spp. and E. coli O157:H7 have been

reported. For the period 1971–1996, 56

outbreaks, resulting in more than 10,000

illnesses and 11 deaths, were attributed

to bacterial pathogen contamination of

public ground water systems. More than

20% of these bacterial outbreaks

occurred since 1991, and several

outbreaks were attributed to gross fecal

contamination of distribution lines.

As previously stated, there may be an

additional 20% of illnesses caused by

bacterial pathogens (in the absence of

viral pathogens) in fecally contaminated

ground water. Therefore, the numbers of

illnesses and deaths presented in Table

II–10 may underestimate the true

numbers of annual illnesses and deaths

by 20% (an estimated 34,000 additional

illnesses and three additional deaths).

9. Summary of Key Observations

In conclusion, EPA believes that at

any one point in time (most

approximately 90 percent) ground water

systems provide uncontaminated water.

However, the risk characterization

described herein indicates that a subset

of ground water systems represent a

potential risk to public health, which

clearly supports the need to proceed

with regulation of these systems.

According to the assessment, EPA

estimates that approximately 168,000

people are at risk to viral illness and 16

people are at risk of death, annually. It

is noted that this analysis focuses

primarily on the potential of

gastrointestinal illness caused by

exposure to viruses, therefore; the

potential for additional illnesses from

ground water contaminated only by

pathogenic bacteria also exists and may

account for an additional 34,000

illnesses and three deaths annually.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30217

Therefore, the estimate of illnesses

represents a potential underestimate of

the actual illnesses attributed to

consumption of water from ground

water systems. Based on this analysis

EPA believes that risk of microbial

illness exists for a substantial number of

people served by ground water systems.

Consequently, EPA believes that the

proposed regulatory provisions

discussed later provide a meaningful

opportunity for public health risk

reduction.

10. Request for Comments

EPA seeks comment on the data,

criteria and methodology used in the

risk assessment, and where any different

approaches may be appropriate. EPA

also seeks comment on the assumptions

used in this assessment, as well as the

conclusions reached, and any additional

data that commenters may be able to

provide on occurrence, exposure,

infectivity, morbidity, or mortality

associated with microbial pathogens in

ground water.

F. Conclusion

In EPA’s judgment, the data and

information presented in previous

sections relating to outbreaks,

occurrence, adverse microbial health

effects, exposure, and risk

characterization demonstrate that there

are contaminants of concerns that exist

in ground water at levels and at

frequencies of public health concern.

Moreover, as discussed in detail later,

the Agency believes there are targeted

risk-based regulatory strategies that

provide a meaningful opportunity to

reduce public health risk for a

substantial number of people served by

ground water sources.

EPA recognizes that there are

particular challenges associated with

developing an effective regulatory

approach for ground water systems.

These include first, the large number of

ground water systems; second, the fact

that only a subset of these systems

appear to have microbial contamination

(although a larger number are likely to

be vulnerable); and third, that most

ground water systems range from being

small to very small in terms of

population served. These factors

combine to underscore the fact that a

one-size-fits-all approach cannot work.

This point was made repeatedly by

participants in public stakeholder

meetings across the country, and EPA

agrees. The task therefore is to develop

a protective public health approach

which ensures a baseline of protection

for all consumers of ground water and

sets in place an increasingly targeted

strategy to identify high risk or high

priority systems that require greater

scrutiny or further action.

III. Discussion of Proposed GWR

Requirements

The information outlined earlier

indicates that the primary causes of

waterborne related illnesses are

associated with source water

contamination and untreated ground

water, source water contamination and

unreliable treatment, water system

deficiencies, and a subset of waterborne

disease outbreaks of unknown causes.

The requirements and options proposed

today address each of these areas

through a multiple-barrier approach

which relies upon five major

components: periodic sanitary surveys

of ground water systems requiring the

evaluation of eight elements and the

identification of significant deficiencies;

hydrogeologic assessments to identify

wells sensitive to fecal contamination;

source water monitoring for systems

drawing from sensitive wells without

treatment or with other indications of

risk; a requirement for correction of

significant deficiencies and fecal

contamination through the following

actions: eliminate the source of

contamination, correct the significant

deficiency, provide an alternative

source water, or provide a treatment

which achieves at least 99.99 percent (4-

log) inactivation or removal of viruses,

and compliance monitoring to insure

disinfection treatment is reliably

operated where it is used.

A. Sanitary Surveys

1. Overview and Purpose

A key element of the multiple-barrier

approach is periodic inspection of

ground water systems through sanitary

surveys. According to the Total

Coliform Rule (TCR), a sanitary survey

is an onsite review of the water source,

facilities, equipment, operation and

maintenance of a public water system

for the purpose of evaluating the

adequacy of such source, facilities,

equipment, operation and maintenance

for producing and distributing safe

drinking water (40 CFR 141.2). The

Agency believes that periodic sanitary

surveys, along with appropriate

corrective actions, are indispensable for

assuring the long-term quality and

safety of drinking water. When properly

conducted, sanitary surveys can provide

important information on a water

system’s design and operations and can

identify minor and significant

deficiencies for correction before they

become major problems. By taking steps

to correct deficiencies exposed by a

sanitary survey, the system provides an

additional barrier to microbial

contamination of drinking water.

The Agency proposes the following

sanitary survey requirements: (1) States,

or authorized agents, conduct sanitary

surveys for all ground water systems at

least once every three years for CWSs

and at least once every five years for

NCWSs; (2) sanitary surveys address all

eight elements set out in the EPA/State

Joint Guidance on sanitary surveys

(outlined later in this section); (3) States

provide systems with written

notification which describes and

identifies all significant deficiencies no

later than 30 days of the on-site survey;

and (4) systems consult with the State

and take corrective action for any

significant deficiencies no later than 90

days of receiving written notification of

such deficiencies, or submit a schedule

and plan to the State for correcting these

deficiencies within the same 90 day

period; and (5) States must confirm that

the deficiencies have been addressed

within 30 days after the scheduled

correction of the deficiencies.

A ground water system that has been

identified as having significant

deficiencies must do one or more of the

following: eliminate the source of

contamination, correct the significant

deficiency, provide an alternate source

water, or provide a treatment which

reliably achieves at least 99.99 percent

(4-log) inactivation or removal of viruses

before or at the first customer. Ground

water systems which provide 4-log

inactivation or removal of viruses will

be required to conduct compliance

monitoring to demonstrate treatment

effectiveness. The ground water system

must consult with the State to

determine which of the approaches, or

combination of approaches, are

appropriate for meeting the treatment

technique requirement. Ground water

systems unable to address the

significant deficiencies in 90 days, must

develop a specific plan and schedule for

meeting this treatment technique

requirement, submit them to the State,

and receive State approval before the

end of the same 90-day period. For the

purposes of this paragraph, a

‘‘significant deficiency’’ includes, : 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.

Sanitary surveys provide a

comprehensive and accurate record of

the components of water systems, assess

the operating conditions and adequacy

of the water system, and determine if

30218 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

past recommendations have been

implemented effectively. The purpose of

the survey is to evaluate and document

the capabilities of the water system’s

sources, treatment, storage, distribution

network, operation and maintenance,

and overall management in order to

ensure the provision of safe drinking

water. In addition, sanitary surveys

provide an opportunity for State

drinking water officials or approved

third party inspectors to visit the water

system and educate operators about

proper monitoring and sampling

procedures, provide technical

assistance, and inform them of any

changes in regulations.

Sanitary surveys have historically

been conducted by State drinking water

programs as a preventative tool to

identify water system deficiencies that

could pose a threat to public health. In

1976, EPA regulations established, as a

condition of primacy, that States

develop a systematic program for

conducting sanitary surveys, with

priority given to public water systems

not in compliance with drinking water

regulations (40 CFR 142.10 (b)(2)). This

primacy requirement did not define the

scope of sanitary surveys or specify

minimum criteria.

In 1989, the TCR included a provision

that requires systems that serve 4,100

people or less and collecting fewer than

five routine total coliform samples per

month to conduct a periodic sanitary

survey every five years, with an

exception made for NCWS that use

protected and disinfected ground water

to conduct the survey every ten years.

The TCR, however, does not establish

what must be addressed in a sanitary

survey or how such a survey should be

conducted. The responsibility is on the

system rather than the State for

completing the sanitary survey (40 CFR

141.21(d)(2)). The TCR requires systems

to use either a State official or an agent

approved by the State to conduct the

sanitary survey.

The IESWTR (63 FR 69478, December

16, 1998), established requirements for

primacy States to conduct sanitary

surveys for all systems using surface

water or ground water under the direct

influence of surface water. The rule also

requires States to have the appropriate

authority for ensuring that systems

address significant deficiencies. The

State must perform a survey at least

once every three years for CWSs and

every five years for NCWSs. These

surveys must encompass the eight major

areas defined by the EPA/State Joint

Guidance (discussed in section 3).

This GWR proposal and the IESWTR

differ in the requirements for a system

to correct any significant deficiency. In

the IESWTR, States are specifically

required to have the appropriate rules or

other authority to require systems to

respond in writing to significant

deficiencies outlined in a sanitary

survey report within at least 45 days. A

system, under this 45-day time frame, is

required to notify the State in writing

how and on what schedule it will

address significant deficiencies noted in

the survey. This GWR proposal differs

from the IESWTR by proposing to

require ground water systems to correct

significant deficiencies and to do so

within 90 days or seek a State approved

schedule for plans requiring longer than

90 days.

2. General Accounting Office Sanitary

Survey Investigation

In 1993, the US General Accounting

Office (US GAO) investigated State

sanitary survey practices. The US GAO

found that many sanitary surveys were

deficient, and that follow-up on major

problems was often lacking. This

investigation, which is described next,

was published as a report, Key Quality

Assurance Program is Flawed and

Underfunded (US GAO 1993).

US GAO was directed by Congress to

review State sanitary survey programs

due to congressional concern that many

States were cutting back on these

programs, and thus undermining public

health. Congress asked US GAO to

determine in its report whether sanitary

surveys are comprehensive enough to

determine if a water system is providing

safe drinking water and what the results

indicate about water systems

nationwide.

As part of this effort, GAO sent a

detailed questionnaire to 49 States to

attain a nationwide perspective on

whether the States were conducting

sanitary surveys, the frequency and

comprehensiveness of the surveys, and

what the survey results indicate about

the operation and condition of water

systems. To obtain more detailed

information, the GAO also focused on

200 specific sanitary surveys conducted

on CWSs in four States (Illinois,

Montana, New Hampshire and

Tennessee). This information was

summarized in the GAO’s report (US

GAO 1993). The GAO report presented

a number of key concerns, as discussed

next.

Frequency Varies Among States and is

Declining Overall. At least 36 States had

a policy to conduct surveys of CWSs at

intervals of three years or less; however,

only 21 of these States were conducting

surveys at this frequency. The

remaining 15 States reported they were

unable to implement this policy because

their inspectors had other competing

responsibilities that often took

precedence over non-mandated

requirements (e.g., sanitary surveys).

Overall, the frequencies of the surveys

vary from quarterly to 10 years.

According to the report, States have

reduced the frequency of surveys since

1988, a downward trend that is

expected to continue.

Comprehensiveness of Sanitary

Surveys is Inconsistent. The report

indicates that a comprehensive sanitary

survey, as recommended in Appendix K

of EPA’s SWTR Guidance Manual (US

EPA, 1990b), is frequently not

conducted. Forty-five out of 48 States

omitted one or more key elements

defined in the 1990 guidance manual.

The GAO noted wide variation among

States in the comprehensiveness of their

sanitary surveys. Some States, for

example, omit inspections of water

distribution systems and/or other key

components or operations of water

systems, others do not provide complete

documentation of sanitary survey

results. Based on a review of the 200

sanitary surveys, survey results which

identify deficiencies were found to be

inconsistently interpreted from one

surveyor to another. In some cases,

systems’ deficiencies that could have

been detected during a comprehensive

survey may not be found until after

water quality is affected and the root

cause(s) investigated. By that time,

however, consumers may already have

ingested contaminated water (US GAO,

1993).

Limited Efforts to Ensure that

Deficiencies are Corrected. The GAO

found that follow-up procedures for

deficiencies were weak. The detailed

review of the four States’ sanitary

surveys indicated that deficiencies

frequently go uncorrected. Of the 200

surveys examined, about 80% disclosed

deficiencies and 60% cited deficiencies

that had already been identified in

previous surveys. Of particular concern

was the GAO finding that smaller

systems (serving 3,300 or less) are in

greatest need of improvements. Small

systems compose a significant majority

of all ground water systems. Ninety-nine

percent (approximately 154,000) of

ground water systems serve fewer than

10,000 people and ninety-seven percent

(approximately 151,000) serve 3,300 or

fewer people.

Results Poorly Documented. The GAO

also found variation in how States

document and interpret survey results.

Proper documentation would facilitate

follow-up on the problems detected.

GAO recommended EPA work with

States to establish minimum criteria on

how surveys should be conducted and

documented and to develop procedures

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30219

to ensure deficiencies are corrected.

This proposal addresses these

recommendations.

3. ASDWA/EPA Guidance on Sanitary

Surveys

Recognizing the essential role of

sanitary surveys and the need to define

the broad areas that all sanitary surveys

should cover, EPA and ASDWA

prepared a joint guidance on sanitary

surveys entitled EPA/State Joint

Guidance on Sanitary Surveys (1995).

The guidance identified the following

eight broad components that should be

covered in a sanitary survey: source,

treatment, distribution system, finished

water storage, pumps and pump

facilities and controls, monitoring/

reporting/data verification, water system

management and operations, and

operator compliance with State

requirements. The EPA/State Joint

Guidance does not provide detailed

instructions on evaluating criteria under

the eight elements; however, EPA has

recently issued detailed supplementary

information as technical assistance

(April 1999, Guidance Manual for

Conducting Sanitary Surveys of Public

Water Systems)(US EPA, 1999e).

—Source. The water supply source is

the first opportunity for controlling

contaminants. The reliability, quality,

and quantity of the source should be

evaluated during the sanitary survey

using available information including

results of source water assessments or

other relevant information. A survey

should assess the potential for

contamination from activities within

the watershed as well as from the

physical components and condition of

the source facility.

—Treatment. The treatment phase

should consider evaluation of the

handling, storage, use and application

of treatment chemicals if the system

includes application of any

chemicals. A review of the treatment

process should include assessment of

the operation, maintenance, record

keeping and management practices of

the treatment system.

—Distribution System. Given the

potential for contamination to spread

throughout the distribution system, a

thorough inspection of the

distribution network is important.

Review of leakage that could result in

entrance of contaminants, monitoring

of disinfection residual, installation

and repair procedures of mains and

services, as well as an assessment of

the conditions of all piping and

associated fixtures are necessary to

maintain distribution system

integrity.

—Finished Water Storage. A survey of

the storage facilities is critical to

ensuring the availability of safe water,

and the adequacy of construction and

maintenance of the facilities.

—Pumps/Pump Facilities and Controls.

Pumps and pump facilities are

essential components of all water

systems. A survey should verify that

the pump and its facilities are of

appropriate design and properly

operated and maintained.

—Monitoring/Reporting/Data

Verification. Monitoring and reporting

are needed to determine compliance

with drinking water provisions, as

well as to verify the effectiveness of

source protection, preventative

maintenance, treatment, and other

compliance-related issues regarding

water quality or quantity.

—Water System Management/

Operations. The operation and

maintenance of any water system is

dependent on effective oversight and

management. A review of the

management process should ensure

continued and reliable operation is

being met through adequate staffing,

operating supplies, and equipment

repair and replacement. Effective

management also includes ensuring

the system’s long-term financial

viability.

—Operator compliance with State

requirements. A system operator plays

a critical role in the reliable delivery

of safe drinking water. Operator

compliance with State requirements

includes state-specific operation and

maintenance requirements, training

and certification requirements, and

overall competency with on-site

observations of system performance.

4. Other Studies

As previously described (see section

I.D.2.), ASDWA examined 28 different

BMPs to determine the effectiveness of

each BMP in controlling microbial

contamination. Within this study,

91.4% of systems surveyed had

implemented a sanitary survey within

the previous five years. The ASDWA

survey found no significant association

with systems that conducted sanitary

surveys and no total coliform

detections. The insignificance of the

association between sanitary surveys

and the detection of bacteria may be due

to the fact that State sanitary surveys are

designed to identify problems (ASDWA,

1998). However, correction of sanitary

survey deficiencies was correlated with

lower levels of total coliform, fecal

coliform, and E. coli.

EPA conducted a survey published in

Ground Water Disinfection and

Protective Practices in the United States

(US EPA 1996a), which confirmed the

GAO finding that considerable

variability among States exists with

regard to the scope and

comprehensiveness of sanitary surveys.

The Environmental Law Reporter

(ELR), a private database of State and

Federal statutes and regulations,

provides some information on current

State regulations for ground water

systems. According to the ELR, only the

State of Washington does not require

sanitary surveys under the TCR

requirement at 40 CFR 141.21(d).

However, most State regulations found

in the ELR are general in nature and do

not specifically address the eight EPA/

State Joint Guidance sanitary survey

components. State regulations vary

considerably in terms of types of

systems surveyed, the content of the

survey, and who is designated to

conduct the surveys (e.g., a sanitarian).

The database indicates that the majority

of States (46 out of 50) do not

specifically require systems to correct

deficiencies. Significantly, a number of

States do not appear to have legal

authority to require correction of

deficiencies. The ELR findings

contained in the Baseline Profile

Document for the Ground Water Rule

(US EPA, 1999f) indicate that many

sanitary survey provisions do not

appear in State regulations. The GAO

report confirmed that many States

incorporated sanitary survey

requirements into policy, thereby

undercutting their legal enforceability.

5. Proposed Requirements

EPA proposes to require periodic

State sanitary surveys for all ground

water systems specifically addressing all

of the applicable sanitary survey

elements noted earlier, regardless of

population size served.

With regard to the frequency of

sanitary surveys, EPA proposes to

require the State or a state-authorized

third party to conduct sanitary surveys

for all ground water systems at least

once every three years for CWSs and at

least once every five years for NCWSs.

This approach would be consistent with

the requirements of the IESWTR. CWSs

would be allowed to follow a five-year

frequency if the system either treats to

4-log inactivation or removal of viruses

or has an outstanding performance

record in each of the applicable eight

areas documented in previous

inspections and has no history of TCR

MCL or monitoring violations since the

last sanitary survey. A State must, as

part of its primacy application, include

how it will decide whether a system has

outstanding performance and is thus

eligible for sanitary surveys at a reduced

frequency.

30220 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

The Agency believes that periodic

sanitary surveys, along with appropriate

corrective measures, are indispensable

for ensuring the long-term safety of

drinking water. By taking steps to

correct deficiencies exposed by a

sanitary survey, the system provides an

additional barrier to pathogens entering

the drinking water.

The definition of a sanitary survey

used in the GWR differs from the

definition of a sanitary survey in 40 CFR

141.2 by a parenthetical clause. For the

purpose of Subpart S, a sanitary survey

is ‘‘an onsite review of the water source

(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.’’ This reflects a recommendation

by the 1997 M/DBP Federal Advisory

Committee Act that sanitary inspectors

should use source water assessments

and other information where available

as part of the overall evaluation of

systems. This change in definition

reflects the value of Source Water

Assessment and Protection Programs

(SWAPPs) required by Congress in the

1996 SDWA amendments and the

importance of utilizing information

generated as a result of that activity.

EPA is also proposing to require that

State inspectors, as part of each sanitary

survey, evaluate all applicable

components defined in the EPA/State

Joint Guidance on Sanitary Surveys and

identify any significant deficiencies.

Some stakeholders have suggested the

comprehensiveness of sanitary surveys

be tailored based upon system size and

type. EPA requests comment on whether

this would be an appropriate approach

and if so, what factors or criteria should

be considered in tailoring the scope or

complexity of the sanitary survey.

Individual components of a sanitary

survey may be separately completed as

part of a staged or phased State review

process as part of ongoing State

inspection programs within the

established frequency interval. In its

primacy package, a State which plans to

complete the sanitary survey in such a

staged or phased review process must

indicate which approach it will take and

provide the rationale for the specified

time frames for sanitary surveys

conducted on a staged or phased

approach basis.

EPA proposes to regard the

requirements for sanitary surveys under

the GWR as meeting the requirements

for sanitary surveys under the TCR (40

CFR 141.21). The reason for this is that

the frequency and criteria of a sanitary

survey under the GWR is more stringent

than that for the TCR. For example, the

TCR does not define a sanitary survey

as precisely as the GWR, which requires

an evaluation of eight elements. In

addition, the frequency of the sanitary

survey under the TCR for CWSs is every

five years, compared to three years (at

least initially) under the GWR. Also, the

TCR requires a survey every ten years

for disinfected NCWSs using protected

ground waters, as compared to every

five years under the GWR. The scope of

the systems that must conduct a sanitary

survey also differs; under the TCR only

systems that collect fewer than five

routine samples per month and serve

less than 4,100 persons are required to

undergo a sanitary survey, compared to

all ground water systems under the

GWR. Given that the proposed sanitary

survey requirements under the GWR are

more stringent than those under the

TCR, EPA notes that a survey under the

TCR cannot replace one conducted

under the GWR, unless that survey

meets the criteria specified in the GWR.

As part of today’s rule, a ‘‘significant

deficiency’’ as identified by a sanitary

survey includes: 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. This is a

working definition developed by the

EPA GWR workgroup.

The Agency proposes to require the

State to provide the system with written

notification which identifies and

describes any significant deficiencies

found in a sanitary survey no later than

30 days after completing the on-site

survey. States would not be required, in

this rule, to provide the system with a

complete sanitary survey report within

the 30 days of completing the on-site

survey. Rather, this rule requires that, at

a minimum, the State provide the

system a written list which clearly

identifies and describes all significant

deficiencies as identified during the onsite survey.

EPA proposes to require a system to:

(1) Correct any significant deficiencies

identified in a sanitary survey as soon

as possible, but no later than 90 days of

receiving State written notification of

such deficiencies, or (2) to submit a

specific schedule and receive State

approval on the schedule for correcting

the deficiencies within the same 90-day

period. The system must consult the

State within this 90-day period to

determine the corrective action

approach appropriate for that system,

consistent with the State’s general

approach outlined in their primacy

package. In performing a corrective

action, the system must eliminate the

source of contamination, correct the

significant deficiency, provide an

alternate source water, or provide a

treatment which reliably achieves at

least 99.99 percent (4-log) inactivation

or removal of viruses before or at the

first customer. Ground water systems

which provide 4-log inactivation or

removal of viruses will be required to

conduct compliance monitoring to

demonstrate treatment effectiveness.

There are cases in which one or more

of the corrective actions listed

previously may be inappropriate for the

nature of the problem, and in these

cases only appropriate corrective

actions must be taken. For example, a

system with a significant deficiency in

the distribution system should not

install treatment at the source water as

the corrective action; that system should

correct the problem in the distribution

system. There may also be fecal sources

that a State does not identify as a

significant deficiency, however the State

may choose to use their authority to

require source water monitoring to

monitor the influence of that fecal

source. Ground water systems which

provide 4-log inactivation or removal of

viruses will be required to conduct

compliance monitoring to demonstrate

treatment effectiveness. States must

confirm that the deficiency has been

corrected, either through written

confirmation from systems or a site visit

by the State, within 30 days after the 90-

day or scheduled correction of the

deficiency. Systems providing 4-log

inactivation or removal of viruses need

not undergo a hydrogeologic sensitivity

assessment or monitor their source

water for fecal indicators.

As noted earlier, States would be

required to have the appropriate rules or

other authority to: (1) Ensure that public

ground water systems correct any

significant deficiencies identified in the

written notification provided by the

State (including providing an alternative

source or 4-log inactivation or removal

of viruses); and (2) ensure that a public

ground water system confirm in writing

any significant deficiency corrections

made as a result of sanitary survey

findings.

The requirements in today’s rule do

not preclude a State from enforcing

corrective action on any significant

deficiencies whether or not they are

identified through a sanitary survey.

EPA is also proposing to require

States, as part of their primacy

application, to indicate how they will

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30221

define what constitutes a significant

deficiency found in a sanitary survey for

purposes of this rule. EPA believes that

this requirement would provide the

State sufficient latitude to work within

their existing programs in addressing

significant deficiencies yet provide

facilities and the public with clear

notice as to what kinds of system

conditions constitute a significant

deficiency. EPA recognizes the

importance of enabling States the

flexibility to identify and define sanitary

survey deficiencies in broad categories

under this requirement (e.g., unsafe

source, improper well construction,

etc.).

Also, in its primacy application,

States must specify if and how they will

integrate SWAPP susceptibility

determinations into the sanitary survey

or the definition of significant

deficiencies.

Based upon input from a number of

State and EPA Regional office experts,

significant deficiencies of ground water

systems may include but are not

limited, to the following types of

deficiencies:

—Unsafe source (e.g., septic systems,

sewer lines, feed lots nearby);

—Wells of improper construction;

—Presence of fecal indicators in raw

water samples;

—Lack of proper cross connection

control for treatment chemicals;

—Lack of redundant mechanical

components where chlorination is

required for disinfection;

—Improper venting of storage tank;

—Lack of proper screening of overflow

pipe and drain;

—Inadequate roofing (e.g., holes in the

storage tank, improper hatch

construction);

—Inadequate internal cleaning and

maintenance of storage tank;

—Unprotected cross connection (e.g.,

hose bibs without vacuum breakers);

—Unacceptable system leakage that

could result in entrance of

contaminants;

—Inadequate monitoring of disinfectant

residual and TCR MCL or monitoring

violations.

6. Reporting and Record Keeping

Requirements

The GWR does not change the

requirements on the system and the

State to maintain reports and records of

sanitary survey information as specified

in 40 CFR 141.33(c) and 142.14(d)(1).

7. Request for Comments

EPA requests comment on all the

information presented earlier and the

potential impacts on public health and

regulatory provisions of the GWR. In

addition, EPA specifically requests

comments on alternative approaches.

Alternative Approaches

a. Content of a Sanitary Survey

i. Grandfathering and Scope of Sanitary

Survey

EPA requests comment on

‘‘grandfathering’’ of surveys conducted

under the TCR if those surveys

addressed all eight EPA/State Joint

Guidance on Sanitary Surveys

components. Under what circumstances

should grandfathering be allowed? Are

there circumstances under which

grandfathering should be allowed even

if the survey did not address all eight

components?

EPA is seeking comment on the level

of detail EPA should use in establishing

the sanitary survey requirement which

addresses the eight sanitary survey

components.

ii. Definition of Significant Deficiency

EPA is also seeking comment on the

proposed definition of ‘‘significant

deficiencies.’’ In this regard, EPA is

requesting comment on whether or not

the Agency should promulgate a

minimum list of specific significant

deficiencies for all States to use in their

programs.

iii. Well Construction and Age

EPA considered specifying, in

addition to sanitary survey elements,

well construction deficiencies and well

age as surrogate measures of well

performance as part of the

hydrogeologic sensitivity assessment

(HSA) or as an independent component

from the sanitary survey or HSA. EPA

considered identifying older wells as

those more likely to be contaminated

because of degradation to the

construction materials over time. EPA

concluded that wells may have been

constructed adequately to protect public

health, but records to document such

construction may no longer be available.

Given these circumstances, EPA

recognizes that down-hole test methods

to evaluate well construction, as

required for some hazardous waste

disposal methods, is neither desirable

nor feasible for PWS wells. In addition,

EPA found that there were few data to

support the concept that older wells

were more likely to be contaminated. In

fact, data from two studies

encompassing more than 200 wells in

Missouri suggest that newer wells were

more likely to be contaminated than

older wells (Davis and Witt, 1998, 1999

and Femmer, 1999). Thus, EPA decided

not to include well construction and age

as measures of the potential fecal hazard

to PWS wells.

Almost all States have well

construction standards, and trade

associations, such as the American

Water Works Association and the

National Ground Water Association,

have also provided recommendations

for well construction. EPA recognizes

the importance of designing,

constructing and maintaining wells so

as to maximize well life and yield and

to minimize potential harmful

contamination. Therefore, the Agency

requests comment on whether well

construction and age should be

considered as a required element within

a sanitary survey or specifically

identified by States as a significant

deficiency. EPA also requests comment

on criteria for evaluating well

construction and age.

b. Frequency

EPA believes that a sanitary survey

cycle of at least once every three years

for CWSs (with certain exceptions

discussed previously) and at least once

every five years for NCWSs most

properly balances public health

protection and State burden issues and

is consistent with the frequency

required for surface water systems.

However, the Agency seeks comment on

whether other alternative time cycles

might be appropriate together with any

applicable rationale that supports that

alternative frequency cycle. Specifically,

EPA requests comment on requiring

States to conduct sanitary surveys for all

ground water systems every five years.

EPA also requests comment on allowing

States to conduct sanitary surveys less

often than once every 5 years if the

system provides 4-log inactivation or

removal. The Agency requests comment

on the resource implications for States

and small systems to perform these

surveys with a frequency of 3–5 years.

In addition, the Agency seeks

comment on requiring the State to

conduct a sanitary survey for new

systems prior to the system serving

water to the public. This requirement

would serve as an added public health

measure to ensure new systems are in

compliance with the GWR sanitary

survey provisions.

c. Follow-Up Requirements

EPA requests comment on requiring

States to schedule an on-site inspection

as follow-up to verify correction of

significant deficiencies, rather than

allowing States to accept written

certification from systems to verify the

correction. EPA requests comment on

alternative approaches for a State to

verify that a significant deficiency has

30222 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

been corrected. EPA notes that followup in this context only applies to

significant deficiencies.

d. Public Involvement

EPA requests comment on including

public involvement and/or meetings for

certain systems to discuss the results of

sanitary surveys. Congress wrote

requirements for extensive public

information and involvement in

programs and decisions affecting

drinking water safety throughout the

1996 amendments to SDWA. For

example, in addition to the new

requirement for CWSs to produce and

distribute annually a Consumer

Confidence Report, the public notice

requirements for PWSs regarding

violations of a national drinking water

standard were made more effective, and

States were required to ‘‘make readily

available to the public’’ an annual report

to the Administrator on the statewide

record of PWS violations, see (SDWA

1414(c)(1)–(3)). Each State’s triennial

report to the Governor on the

effectiveness of and progress under the

capacity development strategy must also

be available to the public. (See SDWA

section 1420(c)(3)). EPA must make the

information from the occurrence

database ‘‘available to the public in

readily accessible form.’’ (See SDWA

section 1445(g)(5)). The public must be

provided with notice and an

opportunity to comment on the annual

priority list of projects eligible for State

Revolving Fund (SRF) assistance that

States will publish as a part of their SRF

intended use plans (See SDWA section

1452(b)(3)(B)). States ‘‘shall make the

results of the source water assessments

* * * available to the public.’’ (See

SDWA section 1453(a)(7)). And, under

several specific provisions of the SDWA

as well as the Administrative Procedure

Act, EPA generally must publish and

make regulations, and a number of

guidance and information documents,

available for public notice and

comment.

These requirements, and others like

them, are integral to both the

philosophy and operation of the

amended SDWA. They reflect Congress’

view that public confidence in drinking

water safety and informed support for

any needed improvements must rest on

full disclosure of all significant

information about water system

conditions and quality, from source to

tap.

The 1996 SDWA Amendments, and

EPA’s implementation of them,

consistently provide for such disclosure

and involvement by means that are

informative, timely, understandable,

and practicable for each size group of

PWSs subject to them. EPA believes that

the principles of public information and

involvement must apply with equal

validity to the GWR, and is considering

including in the final rule provisions to

apply these principles, for disclosure

and involvement. EPA believes that the

following approach meets both tests and

principles, but solicits comment on

alternative means of doing so.

EPA requests comment on what

approaches might be practicable, not

burdensome and workable to involve

the public in working with their system

to address the results of their system’s

sanitary survey. Specifically, EPA

requests comment on requiring ground

water CWSs to notify their consumers,

as part of the next billing cycle, of the

completion of any sanitary survey, and

any significant deficiency(s) and

corrective action(s) identified. The

system would also have to make

information concerning the sanitary

survey available to the public upon

request. Alternatively, the system might

be required to notify customers of the

availability of the survey only, and

provide copies on request, or include

information about the survey in the

annual Consumer Confidence Report

(CCR). EPA requests comment on

whether this approach should be

extended to transient and nontransient

NCWSs as well. EPA also requests

comment on what approaches might be

practicable, not burdensome and

workable to involve the public in

working with their system to address

the results of their system’s sanitary

survey.

B. Hydrogeologic Sensitivity Assessment

1. Overview and Purpose

Occurrence data collected at the

source from public ground water

systems suggest that a small percentage

of all ground water systems are fecally

contaminated. Because of the large

number of ground water systems

(156,000), the GWR carefully targets the

high priority systems and has minimal

regulatory burden for the remaining low

priority systems. The GWR screens all

systems for priority and only requires

corrective action for fecally

contaminated systems and systems with

significant deficiencies. Thus, the

challenge of the hydrogeologic

sensitivity assessment is to identify

ground water wells sensitive to fecal

contamination. The assessment

supplements the sanitary survey by

evaluating the risk factors associated

with the hydrogeologic setting of the

system. EPA believes requiring

hydrogeologic sensitivity analysis for all

non-disinfecting ground water systems

will reduce risk of waterborne disease

by identifying systems with incomplete

natural attenuation of fecal

contamination. EPA bases the following

requirements on: CDC outbreak case

studies, USGS studies of ground water

flow, State vulnerability maps, and US

National Research Council reports on

predicting ground water vulnerability.

For the purposes of this rulemaking,

EPA intends the term ‘‘well’’ to include

any method or device that conveys

ground water to the ground water

system. The term ‘‘well’’ include

springs, springboxes, vertical and

horizontal wells and infiltration

galleries so long as they meet the

general applicability of the GWR (see

section 141.400). The GWR does not

apply to PWSs that are designated

ground water under the direct influence

of surface water; such systems are

subject to the SWTR and IESWTR. EPA

requests comment on this definition of

‘‘well.’’

The hydrogeologic sensitivity

assessment is a simple, low burden,

cost-effective approach that will allow

States to screen for high priority

systems. Systems that are situated in

certain hydrogeologic settings are more

likely to become contaminated. EPA

believes that a well obtaining water

from a karst, fractured bedrock or gravel

hydrogeologic setting is sensitive to

fecal contamination unless the well is

protected by a hydrogeologic barrier. A

State may add additional sensitive

hydrogeologic settings (e.g., volcanic

aquifers) if it believes that it is necessary

to do so to protect public health. A

hydrogeologic barrier is defined as the

physical, biological and chemical

factors, singularly or in combination,

that prevent the movement of viable

pathogens from a contaminant source to

a public supply well. In this proposal,

a confining layer is one example of a

hydrogeologic barrier. The strategy is for

a State to consider hydrogeologic

sensitivity first. If ground water systems

not treating to 4-log inactivation of

viruses are located in sensitive

hydrogeologic settings, then the strategy

allows the State to consider the

presence of any existing hydrogeologic

barriers that act to protect public health.

If a hydrogeologic barrier is present,

then the State can nullify the

determination that a system is located in

a sensitive hydrogeologic setting. If no

suitable hydrogeologic barrier exists,

then the GWR requires the system to

conduct monthly fecal indicator source

water monitoring. Finally, for those

systems where monitoring results are

positive for the presence of fecal

indicators, under the proposed GWR,

States may require systems to eliminate

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30223

the source of contamination, correct the

significant deficiency, provide an

alternate source water, or provide a

treatment which reliably achieves at

least 99.99 percent (4-log) inactivation

or removal of viruses before or at the

first customer. GWSs which provide 4-

log inactivation or removal of viruses

will be required to conduct compliance

monitoring to demonstrate treatment

effectiveness.

The States have experience

implementing a wide variety of methods

suitable for identifying

hydrogeologically sensitive systems.

Also, the States may collect

hydrogeologic information through their

SWAPP (see section I.B.) that is useful

for the hydrogeologic sensitivity

assessments under the GWR. EPA

believes that it would be beneficial if

the States coordinate their SWAPP

analysis with the GWR. By using the

information generated in the SWAPP for

the GWR hydrogeologic sensitivity

assessment, States can effectively

reduce the burden associated with this

requirement.

EPA-approved vulnerability

assessments conducted for the purpose

of granting waivers under the Phase II

and Phase V Rules may also serve as

sources of hydrogeologic information

useful to the State in assessing the

hydrogeologic sensitivity of its GWSs

under the GWR. Under the Phase II (56

FR 30268, July 1, 1991d)(US EPA,1991)

and Phase V (57 FR 31821, July 17,

1992)(US EPA,1992b) Rules, monitoring

waivers may be granted to individual

systems for specific regulated chemicals

(e.g., PCBs and cyanide). Monitoring

frequencies may be reduced or

eliminated by the State if the system

obtains a waiver based on previous

sampling results and/or an assessment

of the system’s vulnerability to each

Phase II and V contaminant. This

evaluation must include the sampling

results of neighboring systems, the

environmental persistence and transport

of the contaminant(s) under review,

how well the source is protected by

geology and well design, Wellhead

Protection Assessments, and proximity

of potential contamination sites and

activities.

2. Hydrogeologic Sensitivity

Sensitive hydrogeologic settings occur

in aquifer types that are characterized

by large interconnected openings (void

space) and, therefore, may transmit

ground water at rapid velocities with

virtually no removal of pathogens.

Sensitive aquifers may be present at or

near the ground surface or they may be

covered by overlying aquifers or soils.

An aquifer is sensitive, independent of

its depth or the nature of the overlying

material, because average water

velocities within that aquifer are rapid.

This allows microbial contaminants to

be transported long distances from their

source at or near the surface and

especially in the absence of a

hydrogeologic barrier. In the following

paragraphs, each sensitive aquifer type

is briefly characterized. It is often

difficult to determine the actual

contaminant removal capabilities of an

aquifer and the and ground water

velocities within an aquifer.

Consequently, the aquifer rock type can

be a surrogate measure in the

hydrogeologic sensitivity assessment.

All soil and rocks have void space, but

aquifers have the largest interconnected

void space. The voids are filled with

water that is tapped by a well. Without

these interconnections, the water could

not flow to a well. In those aquifers with

the largest interconnected void space,

ground water velocities can be

comparable to the velocity of a river,

and the rate of travel can be measured

in kilometers per day (US EPA, 1997b).

Compared to velocities in fine-grained

granular aquifers (aquifers that are not

considered sensitive under the GWR),

ground water velocities in fractured

media are large (Freeze and Cherry,

1979). Sensitive aquifers allow fecal

contaminants to travel rapidly to a well,

with little loss in number due to

inactivation or removal.

In the GWR, three aquifer types are

identified as sensitive: (1) Karst

aquifers, (2) fractured bedrock aquifers,

and (3) gravel aquifers. Each aquifer

type is characterized by the differing

nature and origin of the interconnected

void space. These distinctions are

important to hydrogeologists identifying

these aquifer types. To meet the

requirements of the hydrogeologic

sensitivity assessment of the GWR, it is

sufficient for States to identify the

aquifer type supplying a system. Karst,

fractured bedrock and gravel aquifer

types are at high risk to fecal

contamination by virtue of their

capability to rapidly transmit fecal

contamination long distances over short

time periods.

Several means can be used to evaluate

wells to determine if they are located in

one of the three sensitive hydrogeologic

settings proposed under the GWR. For

example, hydrogeologic data are

available from published and

unpublished materials such as maps,

reports, and well logs. The United States

Geologic Service (USGS), U.S.

Department of Agriculture’s Natural

Resource Conservation Service, USGS

Earth Resources Observation System

Data Center, the EPA Source Water

Assessment and Protection Program and

Wellhead Protection Program, State

geological surveys, and universities

have substantial amounts of regional

and site-specific information. The USGS

has published a national karst map

(USGS, 1984) on which States can locate

karst settings. Karst and other aquifers

may also be identified on finer scale

maps published by States or counties.

For example, the State of Kentucky

contains substantial karst terrain,

documented in complete geologic maps

at the scale of one inch: 2000 feet (7.5

minute quadrangles).

States can base assessments on

available information about the age and

character of the regional geology,

regional maps and rock outcrop

locations. For example, in a karst

setting, the State may have some

additional information such as: (1)

Observations of typical karst features

such as sinkholes and disappearing

streams; (2) well driller logs which

noted the presence of limestone or

crystalline calcite (a mineral that grows

into openings in rock) or a drop in the

drill string as it penetrated a karst

opening; or (3) geologic reports (or

unpublished geological observations)

which identify the presence of

limestone in rock outcrops in the

vicinity of the well.

(a) Karst Aquifers

Karst aquifers are aquifers formed in

soluble materials (limestone, dolomite,

marble and bedded gypsum) that have

openings at least as large as a few

millimeters in radius (EPA 1997b). Over

geologic time periods, infiltrating

precipitation (especially acid rain)

moving through the aquifer has

enlarged, by dissolution, the small

openings that existed when the rock was

formed. In mature karst terrain,

characterized by relatively pure

limestone located in regions with high

precipitation, caves or caverns are

formed in the subsurface, often large

enough for human passage. Ground

water has the potential to flow rapidly

through karst because the void spaces

are large and have a high degree of

interconnection. In addition to the

openings created by solution removal,

karst aquifers, like all consolidated

geologic formations, also contain

fractures that transmit ground water.

The size of these fractures may be small,

but the fractures may also be more

numerous than solution-enhanced

openings. The fractures may or may not

have a high degree of interconnection,

and the degree of interconnection is a

primary factor that controls the velocity

of the ground water.

30224 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

Quinlan (1989) suggests that about 20

percent of the U.S. is underlain by

limestone or dolomite which may be

karst aquifers. East of the Mississippi

River, almost forty percent of the U.S. is

underlain by limestone, dolomite or

marble that may be karst aquifers

(Quinlan, 1989). Karst areas are often

identified by the formation of sinkholes

at the ground surface. A sinkhole forms

when the roof of a cave collapses and

the material that was overlying the cave

is dissolved or otherwise carried away

by streams flowing through the cave.

Sinkholes may also form or become

enlarged as the direct result of vertical

ground water flow dissolving the rock

material to form a vertical passageway.

Sinkholes represent direct pathways for

fecal contamination to enter the aquifer

from the surface. The surface

topography may also be characterized

by dry stream valleys in regions of high

rainfall, by streams that flow on the

ground surface but suddenly sink below

ground to flow within a cave and by

large springs where underground

streams return to the surface. The degree

of karst development in Missouri has

been defined by Davis and Witt (1998)

as primary and secondary karst: primary

containing more than ten sinkholes per

100 square miles and secondary karst

containing between one and ten

sinkholes per 100 square miles. Other

features suitable for identifying karst

aquifers are described in EPA (1997b).

The most direct method for ground

water velocity determinations consists

of introducing a tracer substance at one

point in the ground water flow path and

observing its arrival at other points in

the path, usually at monitoring wells

(Freeze and Cherry, 1979). Using tracer

studies, ground water velocities in karst

aquifers have been measured as high as

0.5 kilometers (km) per hour (US EPA,

1997b). In Florida, ground water

velocities surrounding a well have been

measured at several hundred meters (m)

per hour (US EPA, 1997b). At Mammoth

Cave, Kentucky, ground water velocities

have been measured at more than 300 m

per hour (US EPA, 1997b). In a confined

karst aquifer in Germany, ground water

traveled 200 m in less than 4 days (Orth

et al., 1997). In the Edwards Aquifer,

Texas, Slade et al., (1986) reported that

dye traveled 200 feet in ten minutes.

The water level in one well (582 feet

deep with a water table 240 feet deep)

began rising within one hour after a

rainfall (Slade et al., 1986). These data

suggest that ground water flows

extremely rapidly through karst

aquifers. Because ground water flows

rapidly through karst aquifers, these

aquifers are considered to be

hydrogeologically sensitive aquifers

under the GWR.

(b) Fractured Bedrock

Bouchier (1998) characterizes a

fractured bedrock aquifer as an aquifer

which has fractures that provide the

dominant flow-path. Although all rock

types have fractures, the rock types most

susceptible to fracturing are igneous and

metamorphic rock types (US EPA,

1991c).

Freeze and Cherry (1979) report void

space as high as 10 percent of total

volume in igneous and metamorphic

rock. These rock types readily become

fractured in the shallow subsurface as a

result of shifts in the Earth’s crust. Most

fractures are smaller than one

millimeter (mm) in width but each

fracture’s capability to transmit ground

water varies significantly with the width

of the fracture. A one mm fracture will

transmit 1,000 times more water than a

0.1 mm fracture, provided that other

factors are constant (e.g., hydraulic

gradient) (Freeze and Cherry, 1979).

Data presented in Freeze and Cherry

(1979) suggest that the first 200 feet

beneath the ground surface produces the

highest water yields to wells. These data

suggest that the fractures are both more

numerous and more interconnected in

the first 200 feet interval. The rate of

ground water travel in fractured rock

can be estimated through the results of

tracer tests. Malard et al., (1994) report

that dye traveled 43 m in a fractured

aquifer in two hours. Becker et. al.,

(1998) report that water traveled 36 m

in about 30 minutes. Therefore, ground

water may travel as quickly as several

hundreds of meters per day in fractured

bedrock, comparable to travel times in

karst aquifers.

Aquifers that are comprised of

igneous or metamorphic rock are often

fractured bedrock aquifers, and their

size is typically larger than a few tens

or hundreds of square miles in area.

EPA (1991c) has compiled a map

showing the distribution of fractured

bedrock aquifers in the U.S. Because

ground water flows rapidly through

fractured bedrock aquifers, these

aquifers are considered to be

hydrogeologically sensitive aquifers

under the GWR.

(c) Gravel Hydrogeology

Gravel aquifers are deposits of

unconsolidated gravel, cobbles and

boulders (material larger in size than

pebbles). Due to the large grain sizes of

gravel aquifers, ground water travels

rapidly within these aquifers with little

to no removal or filtration of

contaminants from the ground water.

Such gravel aquifers are typically

produced by catastrophic floods,

physical weathering by glaciers, flashfloods at the periphery of mountainous

terrain or at fault-basin boundaries. For

example, glacial flooding has produced

the Spokane-Rathdrum Prairie aquifer

which extends from Spokane,

Washington to Coeur d’Alene, Idaho.

Another gravel aquifer is associated

with glacial flooding along the Umatilla

River in Milton-Freewater, Oregon. The

boulder zone in the Jacobs Sandstone

and Baraboo Quartzite near Baraboo,

Wisconsin may represent another

example. Typically, these aquifers are

small.

Gravel aquifers are generally not

alluvial aquifers. Alluvial aquifers,

associated with typical river processes,

normally have high proportions of sand

mixed with the gravel. Sand or finer

materials provide a higher probability of

microorganism removal by the aquifer

particles (Freeze and Cherry, 1979), and,

therefore, greater public health

protection. Because ground water flows

rapidly through gravel aquifers, these

aquifers are considered to be

hydrogeologically sensitive aquifers

under the GWR.

3. Hydrogeologic Barrier

The second part of the hydrogeologic

sensitivity assessment is determining

the presence of a hydrogeologic barrier.

Under the GWR, the States perform an

initial screen for hydrogeologic

sensitivity by determining whether a

PWS utilizes a fractured bedrock, karst

or gravel aquifer. States would then

examine systems located in these

sensitive aquifers and determine

whether a hydrogeologic barrier is

present. A hydrogeologic barrier

consists of physical, chemical, and

biological factors that, singularly or in

combination, prevent the movement of

viable pathogens from a contaminant

source to a public water supply well. If

the State determines that a

hydrogeologic barrier is present, the

hydrogeologic setting is no longer

considered sensitive to fecal

contamination. If no such barrier is

present or if insufficient information is

available to make such a determination,

the system would be identified as a

sensitive system.

It is difficult to describe a single,

detailed methodology for identifying a

hydrogeologic barrier that can be used

on a national basis. Geological and

geochemical conditions, climate, and

land uses are highly variable throughout

the United States. In its primacy

application, each State seeking

consideration of a proposed

hydrogeologic barrier under the rule

may identify an approach for

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30225

determining the presence of a

hydrogeologic barrier that addresses its

own unique set of these variables (e.g.,

geological and geochemical conditions,

climate, and land uses). In determining

the presence of a hydrogeologic barrier,

the State should evaluate specific

characteristics of the hydrogeologic

setting, discussed in more detail in the

following paragraphs.

Examples of characteristics to be

considered in determining the presence

of a hydrogeologic barrier include, but

are not limited to: (1) Subsurface

vertical and horizontal ground water

travel times or distances sufficiently

large so that pathogens become

inactivated as they travel from a source

to a public water supply well, or (2)

unsaturated geological materials

sufficiently thick so that infiltrating

precipitation mixed with fecal

contaminants is effectively filtered

during downward flow to the water

table.

A confining layer is one type of

hydrogeologic barrier EPA has

identified which can result in sufficient

protection in many settings. A confining

layer may protect sensitive aquifers

from fecal contamination. It is defined

as a layer of material that is not very

permeable to ground water flow which

overlies an aquifer and acts to prevent

water movement into the aquifer (US

EPA, 1991b). Confined aquifers are

bounded by confining layers and,

therefore, generally occur at depth,

separated from the water table aquifer at

the surface. Confining layers are

typically identified by the high water

pressures in the underlying aquifer.

Where present, a confining layer will

separate an aquifer of high pressure

from an overlying aquifer of lower

pressure. The high water pressure in a

confined aquifer can force water to flow

naturally (without pumping) to heights

greater than the ground surface, as in an

artesian well. The confining layer is

comprised of fine-grained materials

such as clay particles, either as an

unconsolidated layer or as a

consolidated rock (e.g., shale). The

small size of clay particles restricts the

movement of water across or through

the clay layer. Freeze and Cherry (1979)

determined that water would take

almost 10,000 years to pass through a 10

meters-thick unfractured layer of silt

and clay deposited at the bottom of a

glacial lake, such as the layers present

in the northern part of the United States

and the southern part of Canada.

Therefore, the presence of a confining

layer can provide public health

protection.

However, confining layers may be

breached and, therefore, unprotective.

Breaches may be natural (e.g., partly

removed by erosion, sinkholes, faults,

and fractures) or caused by humans

(e.g., wells, mines, and boreholes). For

example, an unplugged, abandoned well

that breaches the confining layer is

capable of providing a pathway through

the confining layer, allowing water and

contaminant infiltration into ground

water. A thicker, unpunctured confining

layer is considered most protective of

the underlying aquifer. The State should

consider such confined aquifer

characteristics in determining the

adequacy of a confining layer as a

hydrogeologic barrier.

EPA proposes to use the presence of

a confining layer that is protective of the

aquifer to act as a hydrogeologic barrier

and nullify a sensitivity determination.

Where the confining layer integrity is

compromised by breaches or if the

aquifer appears at the surface near the

water supply well, the State shall

determine if the layer is performing

adequately to protect the well, and,

therefore, public health. EPA estimates

approximately 15 percent of

undisinfected ground water system

sources will be determined to be

hydrogeologically sensitive (see RIA

section 6.2.1.1).

4. Alternative Approaches to

Hydrogeologic Sensitivity Assessment

EPA recognizes that the States have

substantial experience characterizing

hydrogeology. Most States require some

hydrogeologic information for reasons

such as to delineate wellhead protection

areas, manage ground water extraction

or assess ground water contamination.

EPA recognizes that there is no single

approach for identifying systems at risk

from source water contamination. In the

GWR, a selected subset of hydrogeologic

settings (karst, fractured bedrock and

gravel aquifers) is hydrogeologically

sensitive. These hydrogeologic settings

are identified through regional and local

maps that show the general distribution

of these settings. Other approaches

considered by EPA to identify sensitive

systems, but not selected, require

additional data that may not be

available to all States. In the following

paragraphs, alternative methods to

identify sensitive systems are discussed,

including the data requirements for

implementing each approach.

(a) Horizontal Ground Water Travel

Time

Horizontal ground water travel time is

the time that a water volume requires to

travel through an aquifer from a fecal

contamination source to a well. Viruses

are longer lived than bacteria. Therefore,

the ground water travel time should

allow sufficient virus die-off to take

place such that the concentration of

viruses in the well water would be at or

below a 1 in 10,000 annual risk level

(Regli et. al., 1991). However, travel

time determinations are site specific,

and some methods are expensive and/or

difficult to perform. Therefore, EPA is

not prescribing a particular travel time

as a hydrogeologic sensitivity

assessment criterion under the GWR.

Travel time information may be useful

for evaluating hydrogeologic barrier

performance, and States may make use

of this information where available.

Ground water travel time

measurement methods include

conservative tracer tests (e.g., dyes,

stable isotopes), and travel time

calculations. Conservative tracer tests

may be used in all aquifer types

including karst and fractured bedrock,

as well as porous media aquifers. Tracer

tests are expensive and difficult to

perform. Ground water travel time

calculations are only suitable for porous

media aquifers. Because travel time

methods are site-specific and their

associated levels of uncertainty vary,

EPA is not prescribing one travel time

number or method to be used

nationally.

In evaluating whether to require a

specific ground water travel time, EPA

recognized that there are three problems

with requiring this method for all States.

First, all ground water travel time

calculations require measurement of the

aquifer porosity (void space). Aquifer

porosity data are rare and usually must

be estimated based on the aquifer

character (e.g., sand, or sand and

gravel). Second, ground water travel

time calculations require knowledge of

the distance traveled and water velocity;

however, calculating travel time is

complicated because ground water does

not travel in a straight line. The ground

water’s flow path can be nearly straight,

as in the case of cavernous karst or it

can be very convoluted as found in

fractured media. Third, the ground

water travel time value represents the

average travel time of a large water

volume moving toward a well. Some

water arrives more quickly than the

average. Because viruses and bacteria

are small in size their charge effects

become important. As a result, some

fecal contaminants may take the fastest

path from source to well and arrive

faster than the average water volume.

Fecal contaminants introduced into an

aquifer may or may not be channeled

into flow paths that move faster than the

average water volume. Thus, a

calculation of the average ground water

travel time is not as protective as the

calculation of the first arrival time of the

30226 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

ground water volume. Because of the

additional uncertainty in calculating

first arrival times, average travel times

must be augmented with a safety factor.

Travel time data, where available, may

assist States in evaluating hydrogeologic

barriers for localities where all sources

of fecal contamination have been

identified.

(b) Setback Distance

A setback distance is the distance

between a well and a potential

contamination source. Many States

already use setback distances around a

well as exclusion zones in which septic

tanks are prohibited.

EPA compiled data on State sanitary

setback distances for PWS wells. EPA

found that there is little uniformity

among the States. State setback

distances from septic tanks or drain

fields for new PWS wells range from 50

to 500 feet. Moreover, some States have

differing setback distances depending

on the well type (e.g., CWS versus

NTNCWS and TNCWS ), the well

pumping rate (e.g., greater or less than

50 gallons per minute) or the microbial

contaminant source type (e.g., 50 feet

from a septic tank and 10 feet from a

sewer line).

EPA considered using a strategy that

included the setback distance as an

element in determining the potential

fecal hazard to systems. In this strategy,

wells located near contamination

sources are at risk. EPA concluded that

it would be difficult to implement this

strategy on a national scale for two

reasons. First, the differing State setback

distance requirements suggests that

there is substantial disagreement among

the States about an appropriate setback

distance. Second, any setback distance

selected for use in the GWR must be

sufficiently large so as to protect a well

from fecal contamination. The

complexity of the processes that govern

virus and bacterial transport in ground

water and the variability of ground

water velocity in sensitive

hydrogeologic settings make it difficult,

if not impossible, for EPA to specify

setback distances that will be protective

of public health for all hydrogeologic

settings. Thus, EPA concluded that

there was insufficient scientific data to

mandate national setback distances in

the GWR.

(c) Well and Water Table Depth

Well depth is the vertical distance

between the ground surface and the well

intake interval or the bottom of the well.

Water table depth is the vertical

distance between the ground surface

and the water table. Infiltrating ground

water can require substantial time to

reach a deep well or a deep water table

because precipitation infiltrating

downward to the water table and

vertical ground water flow within an

aquifer are typically slow, and thus the

long infiltration path to a deep well or

water table provides opportunities for

inactivation or removal of pathogens

and is protective against source water

contamination.

EPA considered identifying well

depth and water table depth as

alternative hydrogeologic sensitivity

methods. Two key pieces of information

would then be needed for each well: (1)

Aquifer measurements that describe its

capability to vertically transmit ground

water and (2) measurements from the

soil and other material overlying the

water table that describe its capability to

transmit infiltrating precipitation mixed

with fecal contamination. EPA believes

that few data are available to describe

vertical ground water flow or infiltration

on a national level. Thus, EPA

concluded that there was insufficient

data available to determine a well depth

at which there exists a fecal

contamination risk for all systems on a

national scale.

5. Proposed Requirements

(a) Assessment Criteria

Today’s proposal provides that States

shall identify high priority systems

through a hydrogeologic sensitivity

assessment. In this assessment, wells

located in karst, fractured bedrock or

gravel hydrogeologic settings are

determined to be sensitive. The

information provided in previous

paragraphs shows that the wells located

in these hydrogeologic settings are

potentially at risk of fecal contamination

because ground water velocities are high

and fecal contamination can travel long

distances over a short time. A

hydrogeologic barrier can protect a

sensitive aquifer, and if present, can

nullify the sensitivity determination. In

its primacy application, a State shall

identify its approach to determine the

presence of a hydrogeologic barrier. For

example, a State may choose to consider

a specific depth, hydraulic conductivity,

and the presence of improperly

abandoned wells. For systems with one

or more wells that potentially produce

ground water from multiple aquifers,

the State shall identify its approach to

making separate hydrogeologic

sensitivity determinations and, if

appropriate, hydrogeologic barriers

identifications, for each well. For

example, a State may choose to consider

a specific depth and hydraulic

conductivity, improperly abandoned

wells. The system shall provide to the

State or EPA, at its request, any

pertinent existing information that

would allow the State to perform a

hydrogeologic sensitivity analysis. The

hydrogeologic sensitivity assessment

does not necessarily require an on-site

visit by the State, provided the State has

adequate information (geologic surveys,

etc.) to make the assessment without a

site visit.

Discussions of proposed monitoring

requirements for hydrogeologically

sensitive systems are found in section

III.D., and corrective action

requirements are found in section III.E.

(b) Frequency of Assessment

The States, or their authorized agent,

shall conduct one hydrogeologic

sensitivity assessments for each GWS

that does not provide treatment to 4-log

inactivation or removal of viruses.

States shall conduct the hydrogeologic

sensitivity assessment for all existing

CWSs no later than three years after

publication of the final rule in the

Federal Register and for all existing

NCWSs no later than five years after

publication of the final rule in the

Federal Register. States shall complete

the hydrogeologic sensitivity assessment

prior to a new ground water system

providing drinking water for public

consumption. EPA requests comment on

these time frames. Some stakeholders

have indicated that an assessment for

hydrogeologically sensitive areas (karst,

gravel, fractured rock) of a State can be

quickly performed at the State level. If

such data can be quickly gathered and

an assessment easily performed, EPA

questions putting off the routine

monitoring requirements and public

health protection that it would bring for

three or five years. EPA requests

comment on requiring the State to

perform the hydrogeologic sensitivity

assessment within one year of the

effective date of the final GWR.

(c) Reporting and Record Keeping

Requirements

The State shall keep records of the

supporting information and explanation

of the technical basis for determinations

of hydrogeologic sensitivity and of the

presence of hydrogeologic barriers. The

State shall keep a list of ground water

systems which have had a sensitivity

assessment completed during the

previous year, a list of those systems

which are sensitive, a list of those

systems that are sensitive, but for which

the State has determined a

hydrogeologic barrier exists at the site

sufficient for protecting public health,

and a record of an annual evaluation of

the State’s program for conducting

hydrogeologic sensitivity assessments.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30227

6. Request for Comments

EPA requests comments on all the

information presented earlier and the

potential impacts on public health and

the regulatory provisions of the GWR.

a. Routine Monitoring Without State

Assessment

EPA requests comment on requiring

systems to perform routine monitoring if

the State fails to conduct a

hydrogeologic sensitivity assessment.

Under this provision, if the State fails to

conduct a hydrogeologic sensitivity

assessment within the time frame

specified by the GWR, the systems

would conduct fecal indicator

monitoring once per month for every

month they serve water to the public

(see section § 141.403(d), microbial

analytical methods). The time frame for

completing sensitivity assessments for

all existing CWSs is no later than three

years after the date of publication of the

final rule in the Federal Register, and

the time frame for all existing NCWSs is

no later than five years after the date of

publication of the final rule in the

Federal Register. The systems could

discontinue monitoring only after the

State conducts a hydrogeologic

sensitivity assessment and determines

that the systems are not sensitive, or if

the systems initiate and continue

treatment to achieve 4-log inactivation

or removal of viruses.

b. Vulnerability Assessment

EPA requests comment on a detailed,

on-site vulnerability investigation as an

alternative to the Hydrogeologic

Sensitivity Assessment. The alternative

hydrogeologic investigation will assess

the performance of all existing

hydrogeologic barriers such as

unsaturated zone thickness and

composition (including the soil), the

saturated zone thickness and

composition above the well, intake

interval, the frequency, duration and

intensity of precipitation for all aquifer

types, and will also require a detailed

investigation of the well construction

conditions by a certified well technician

and a review of the well constructionrelated documentation from the sanitary

survey and SWAPP assessment. The

results of the detailed investigation

must demonstrate that the existing

hydrogeologic barriers, aquifer type and

the well construction function to

prevent the movement of viable

pathogens from a contaminant source to

a public water supply well. The

demonstration may include ground

water age dating, natural or artificial

tracer test data, or ground water

modeling results. See EPA 1998b for

more information on vulnerability

assessments.

c. Sandy Aquifers

EPA is proposing to require States to

identify systems in karst, gravel and

fractured rock aquifer settings as

sensitive and these systems must

perform routine source water

monitoring. On March 13, 2000, the

Drinking Water Committee of the

Science Advisory Board (DWCSAB)

reviewed this issue and made several

recommendations to EPA concerning a

draft of this proposal. EPA requests

comment on two DWCSAB

recommendations concerning the

hydrogeologic sensitivity assessment.

The committee recommended that all

ground water sources be required to

monitor for bacterial indicators and

coliphage for at least one year—

regardless of sensitivity determination.

As an alternative approach, the

committee recommended sand aquifers

be included as sensitive settings. This

recommendations was based on column

studies of virus transport in soils that

showed that viruses move rapidly

through sandy soils and field studies of

virus transport from septic tanks

showing rapid movement into ground

water from sandy coastal plains.

C. Cross Connection Control

EPA is concerned about introduction

of fecal contamination through

distribution systems; however, EPA has

not proposed cross connection control

requirements in the GWR. EPA will

work with the Microbial/DBP FACA to

consider whether cross connection

control should be required in future

microbial regulations, particularly

during the development of the Long

Term 2 ESWTR, in the context of a

broad range of issues related to

distribution systems. EPA will also

request input from the FACA on

whether to require systems to maintain

disinfection residual throughout the

distribution system. EPA seeks

comments or additional supporting data

related to cross connection control or

other distribution system issues. In

particular to cross connections, the

Agency requests public comment on: (1)

Whether EPA should require States and/

or systems to have a cross connection

control program, (2) what specific

criteria, if any, should be included in

such a requirement, (3) how often a

program should be evaluated, (4) and

whether EPA should limit any

requirement to only those connections

identified as a cross connection by the

public water system or the State. The

Agency also requests comment on what

other regulatory measures EPA should

consider to prevent contamination of

drinking water in the distribution

system.

D. Source Water Monitoring

1. Overview and Purpose

As previously stated, EPA recognizes

that there are particular challenges

associated with developing an effective

regulatory approach for ground water

systems. These include the large

number of ground water systems that

would be regulated, the fact that only a

subset of these systems appear to have

fecal contamination (although a larger

number are likely to be sensitive), and

that most ground water systems range

from small to very small in terms of the

population served. These factors

combine to underscore the limitations of

an across-the-board disinfection

approach to regulation.

As part of the multiple-barrier

approach, EPA proposes source water

monitoring requirements that fulfill the

need for a targeted risk-based regulatory

strategy by identifying those systems

with source water contamination and

systems with high sensitivity to possible

fecal contamination—specifically

undisinfected systems located in

hydrogeologically sensitive aquifers.

EPA believes that the proposed

requirements provide a meaningful

opportunity to reduce public health risk

for a substantial number of people

served by ground water sources. This

section provides detailed information

on current monitoring requirements,

monitoring data, indicators of fecal

contamination, co-occurrence issues,

and describes the proposed

requirements.

EPA proposes the following source

water monitoring requirements for

systems that do not treat 4-log removal

and/or inactivation of viruses: (1) A

system must collect a source water

sample within 24 hours of receiving

notification of a total coliform-positive

sample taken in compliance with the

TCR, and test for the presence of E. coli,

enterococci or coliphage; and (2) any

system identified by the State as

hydrogeologically sensitive through a

sensitivity assessment (see § 141.403)

must conduct routine monthly

monitoring, during the months the

system supplies water to the public, and

analyze for E. coli, enterococci or

coliphage. In either case, if any sample

is fecal indicator-positive, the system

would have to notify the State

immediately and then the system must

take corrective action.

Currently, all systems must comply

with the TCR (see section I.B.1.) and the

MCL for nitrates and nitrites. In

30228 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

addition, CWSs and NTNCWSs must

monitor at the entrance of the

distribution system for 15 additional

inorganic chemicals associated with an

MCL (e.g., antimony, arsenic) and

sometimes other inorganic chemicals

not associated with an MCL (calcium,

orthophosphate, silica, sodium,

sulphate; 40 CFR 141.23(b) and (c)).

Systems will also have to comply with

the Stage 1 DBPR, if they use a chemical

disinfectant. CWSs must additionally

monitor for certain organic chemicals

and certain radionuclides. Ground water

systems under the direct influence of

surface water must satisfy the

requirements of the SWTR and IESWTR.

Microbial monitoring plays an

important role in detecting fecal

contamination in source waters, as well

as in assessing best management

practices, including in-place

disinfection adequacy and distribution

system integrity. It is the most direct

way to determine the presence of fecal

contamination. However, because of

limitations on sample volume,

monitoring frequency, and the species

of microorganisms that can reasonably

be monitored, non-detection of a fecal

indicator does not necessarily mean

fecal contamination is absent (see

Tables III–2 and 3).

2. Indicators of Fecal Contamination

Two approaches for determining

whether a well is contaminated are to

monitor for the presence of either

specific pathogens or more general

indicators of fecal contamination.

Monitoring for individual pathogens,

however, is impractical because the

large number and variety of pathogens

require extensive sampling and

numerous analytical methods. This is a

process which is extremely timeconsuming, expensive, and also

technically demanding. Moreover,

methods are not available for some

pathogens and pathogen concentrations

in water are usually sufficiently small so

as to require analysis of large-volume

samples, which significantly increases

analytical costs. For these reasons, EPA

is focusing on indicators of fecal

contamination as a screening tool rather

than on individual pathogens

themselves. The Agency is considering

several promising fecal indicators: E.

coli, enterococci, somatic coliphage, and

male-specific coliphage. Because these

indicators are closely associated with

fecal contamination, EPA believes that

even a single positive sample should

require urgent State notification and

other follow-up activities.

EPA considered three bacterial

microorganisms as indicators of fecal

contamination: E. coli, enterococci, and

C. perfringens. E. coli and enterococci

are both closely associated with fresh

fecal contamination and are found in

high concentrations in sewage and

septage. Analytical methods are

commercially available, simple, reliable,

and inexpensive. E. coli is monitored

under the TCR, and E. coli and

enterococci are recommended by EPA as

indicators for fecally contaminated

recreational waters. A drawback is that

these two groups may die out more

quickly or be less mobile in the

subsurface environment than some

waterborne pathogens.

As with E. coli and enterococci, C.

perfringens is common in sewage (about

10 6 organisms per liter) and is

associated with fecal contamination.

Methods of detection are commercially

available, simple, reliable, and relatively

inexpensive. C. perfringens forms

protective spores (endospores), and

these spores survive much longer in

some environments than most

pathogens. Thus, these spores may be

present in old fecal contamination

where fecal pathogens are no longer

viable. EPA rejected C. perfringens as an

indicator of fecal contamination for

GWSs based on co-occurrence data

showing that the organism is seldom

present in ground water when other

fecal indicators are present (Lieberman

et. al., 1999).

Enteric viruses, much smaller in size

than bacteria such as E. coli, may be

more mobile than bacteria because they

can slip through small soil pores more

rapidly. Thus, viral pathogens may

sometimes be present in ground water

in the absence of bacterial indicators of

fecal contamination. However, other

factors such as sorption to soil and

aquifer particles are also important in

affecting the relative transport of viruses

and bacteria in ground water.

The coliphage are viruses that infect

the bacterium E. coli. Because they do

not often infect other bacteria, they (like

E. coli) are closely associated with

recent fecal contamination. Because

they are viruses, their stability and

transport within soil and under aquifer

environmental conditions may be

similar to the fate and transport of

pathogenic viruses. There are two

categories of coliphage—somatic

coliphage and male-specific coliphage.

The somatic coliphage are a

heterogenous group that enters the cell

wall of E. coli. The male-specific (also

called the F-specific) phage are those

that only enter through tiny hair-like

appendages (pili) to the cell wall.

There are issues about using

coliphage as an indicator of fecal

contamination in small communities.

Individuals do not consistently shed

coliphage. For example, Osawa et al.

(1981) found that only 2.3% of infected

individuals shed male-specific phage.

Thus, the occurrence of these viruses in

small septic tanks, which is an

important source of fecal contamination

in ground water wells, is uncertain. The

issue of frequency and abundance is

important because a primary source of

fecal contamination in wells is thought

to be nearby leaking septic tanks.

To answer this question, EPA funded

a study to determine (Deborde, 1998,

1999) the frequency and density of

coliphage occurrence in household

septic tanks. Deborde (1998) collected

and analyzed a sample from each of 100

sites in the Northwest and from each of

12 sites in the Midwest (3), Southwest

(3), Northeast (3), and Southeast (3). All

112 samples were analyzed for malespecific coliphage, while 33 were also

analyzed for somatic coliphage. Table

III–1 shows that male-specific coliphage

are present in about one-third of the

septic tank samples, while somatic

coliphage are present in two thirds of

the samples tested. However, when

found, the male-specific coliphage are

present at a slightly higher level. The

number of possible people per

household (and therefore the number of

virus sources) varied from one to seven,

with an average of 2.8. In the next phase

of the study, Deborde (1999), selected

ten of the 112 sites (five coliphagepositive, five coliphage-negative) and

collected three quarterly samples from

each. The data indicate that significant

changes in density occur over time. For

the male-specific phage, the number of

positive sites was 40%, 60% and 40%

for quarter 2, 3, and 4, respectively. For

the somatic phage, the number of

positive sites was 70%, 80% and 50%

during these same three quarters. As in

the first phase, somatic phage were

detected more frequently and the malespecific phage were (when detected)

more abundant.

The data indicate that household

septic tanks often (50–80%) contain

measurable levels of somatic coliphage,

suggesting that the somatic coliphage

may be an appropriate indicator of fecal

contamination in nearby source waters.

However, the male-specific coliphage

were present in the septic tanks in

slightly less than half the sites at any

one time. Based on these data, malespecific phage may not be suitable for

detecting fecal contamination in source

waters if the most likely contamination

source is a household septic tank.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30229

TABLE III–1.—FREQUENCY AND DENSITY OF COLIPHAGE IN HOUSEHOLD

SEPTIC TANKS, PRELIMINARY RESULTS (DEBORDE, 1998)

Coliphage Presence Density 1

Male-specific.36% (44/112) 9.7 × 10 5 PFU 1/

L

Somatic .... 67% (22/33) 1.3 × 10 5

PFU 1 /L

1Plaque-Forming Units (PFU).

Analytical methods for coliphage are

available and are far less expensive than

methods for pathogenic virus detection.

However, the coliphage detection

methods are still somewhat more

expensive than those for the common

indicator bacteria. EPA is in the process

of funding the development of more

sensitive, less expensive analytical

methods for the somatic and malespecific coliphage.

EPA also considered methods using

polymerase chain reaction (PCR) for

identifying specific viruses. PCR

amplifies the nucleic acid of the

targeted virus, which then can be

detected and identified by various

procedures. An advantage of this

method over those for coliphage is that

it can identify the presence of specific

viruses pathogenic to humans. Methods

using PCR may be specific, sensitive,

and much more rapid than other

methods for pathogenic virus. However,

current PCR technology cannot yet

determine whether a virus is viable or

infectious and is significantly more

expensive than the culture methods for

the above fecal indicators (currently

about $250–300 per sample). EPA

expects substantial reductions in this

cost as the method is further developed.

Nevertheless, in spite of the current

limitations of PCR, a positive result in

a ground water sample would strongly

imply that a pathway exists for virus

contamination of ground water.

EPA did not consider total coliform

bacteria or heterotrophic bacteria as

fecal indicators because both groups

grow naturally in soil and water, and

thus are not specific indicators of fecal

contamination.

According to a survey of ground water

data by the AWWARF study (see Table

II–6), C. perfringens was only detected

in one of 57 samples (1.8%). Thus, EPA

eliminated this organism from

consideration. See Tables III–2 and 3 for

occurrence data on candidate indicators.

TABLE III–2.—PRESENCE/ABSENCE OF INDICATORS AT ENTEROVIRUS-POSITIVE SITES (GENERALLY, ONE SAMPLE/SITE)

Study

Number of

positive

enterovirus

sites

Total coliforms

(100 mL)

E. coli or fecal

coliforms

Enterococci or

fecal

streptococci

(100 mL)

Somatic phage

(100 L)

F–specific

phage

(100 L)

AWWARF Study ...................................... 22 4 NA 1 2 2 0 2 2 (3)

Missouri Alluvial Study ............................. 11 5 3 5 1 0

Missouri Ozark Plateau ............................ 10 0 0 0 0 2

1Only 11 enterovirus-positive sites tested.

2 15 liter samples.

TABLE III–3.—DATA FROM EPA/AWWARF STUDY. NUMBER OF TIMES INDICATOR WAS POSITIVE IN 12 MONTHLY

SAMPLES AT ENTEROVIRUS-CONTAMINATED SITES 1

Enterovirus-positive site (≥ 1⁄12 pos) Total

coliform-positive

E. coli

positive

Enterococcipositive

Somatic

coliphagepositive 2

F–specific

coliphage

positive 2

029 ......................................................... 12 12 12 12 11

031 ......................................................... 12 6 5 9 3

047 ......................................................... 12 10 12 12 4

061 ......................................................... 11 11 10 11 8

091 ......................................................... 10 3 5 12 0

097 ......................................................... 5 0 1 4 0

099 ......................................................... 2 0 1 0 1

Total ................................................ 64 42 46 60 27

1Sample volume: bacteria 300 mL; coliphage most between 10–100L; enterovirus: average of 6,037 L.

2 Host for somatic coliphage: E. coli C; host for F-specific coliphage: WG49.

The data strongly shows that a single

negative sample is usually not sufficient

to demonstrate the absence of fecal

contamination, and that repeated

sampling is necessary. Based on the

data, EPA does not believe that one fecal

indicator is clearly superior to the

others.

The coliphage sample volume in the

studies in Table III–3 ranged from 10L

to 100L (compared to 100–300 mL for

the bacterial indicators). EPA believes

that it would be unreasonable to expect

systems to collect and transport these

high water volumes. However, as stated

earlier, several sensitive coliphage

methods have been developed that can

be used with a more reasonable volume

(100–1000 mL).

Thus, for the reasons indicated

earlier, EPA is proposing E. coli,

coliphage and enterococci as

appropriate monitoring tools for source

water. Because these three fecal

indicators are closely associated with

fecal contamination, the Agency

believes that a single source water

positive E. coli, coliphage or enterococci

sample is sufficient to consider the

source water as fecally contaminated.

Repeated sampling is proposed for

routine monitoring (described in the

next section) since it may take more

than one sample to identify intermittent

contamination. Additional support for

this approach is provided by Christian

and Pipes (Christian and Pipes, 1983),

who found that coliforms follow a

lognormal distribution pattern in small

distribution systems (i.e., coliforms are

not uniformly distributed). EPA has no

reason to suspect that this non-uniform

pattern should be different in source

waters. Only one additional sample is

proposed after triggered monitoring

(described in the next section) since the

30230 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

sample is taken immediately after an

indication of contamination.

The Agency recognizes that errors in

sample collection and testing may

contaminate a sample, and therefore

would allow the State to invalidate such

samples, on a case-by-case basis, in the

same manner required under the TCR

(141.21(c)(1)(i) and (iii) for invalidating

total coliform samples. However, EPA

believes that errors in sample collection

rarely lead to contamination. This is

based on a study by Pipes and Christian

(Pipes and Christian, 1982), where water

samplers and other individuals tried to

contaminate 111 sample bottles

containing 100-mL of sterile

dechlorinated tap water by placing a

finger into the mouth of each bottle and

shaking the bottle vigorously for about

5 seconds. Only 5.4% of the samples

were found to contain total coliforms.

Thus, the Agency believes that States

should invalidate positive samples

sparingly. Under the GWR, the State

would be allowed to invalidate a

positive source water sample if (1) the

laboratory establishes that improper

sample analysis caused the positive

result or (2) the State has substantial

grounds to believe that a positive result

is due to a circumstance or condition

which does not reflect source water

quality, documents this in writing, and

signs the document. In this case,

another source water sample must be

taken within 24 hours of receiving

notice from the State.

3. Proposed Requirements

a. Routine Source Water Monitoring

EPA stated in the previous section on

hydrogeology that a State would be

required to determine the

hydrogeological sensitivity of each

system not treating to 4-log inactivation

or removal of viruses. If the State

determines that the well(s) serving such

a system draws water from a sensitive

aquifer, that system would be required

to collect a source water sample each

month that it provides water to the

public and test the sample for the fecal

indicator specified. If any sample

contains a fecal indicator, the system

would be required to notify the State

immediately and address the

contamination within 90 days unless

the State has approved a longer

schedule (see § 141.404).

Under the GWR, if a system detects no

fecal indicator-positive samples after 12

monthly samples, the State would be

allowed to reduce routine source water

monitoring to quarterly. The State

would be allowed, after the first year of

monthly samples, to waive source water

monitoring altogether for a system if the

State determines that fecal

contamination of the well(s) is highly

unlikely, based on sampling history,

land use pattern, disposal practices in

the recharge area, and proximity of

septic tanks and other fecal

contamination sources. PWSs that do

not operate year-round would need to

conduct monthly sampling for more

than one year to collect the twelve

monthly samples. EPA requests

comment on allowing such systems to

monitor monthly for only one seasonal

period when the system is in operation.

b. Source Water Sample After a Total

Coliform-Positive Under the TCR

EPA proposes that when a nondisinfecting ground water system is

notified that a sample is total coliformpositive under the TCR, that system

would have to collect, within 24 hours

of being notified, at least one source

water sample. This requirement would

be in addition to all monitoring and

testing requirements under the TCR.

The source water sample would be

tested for either E. coli, coliphage or

enterococci, as determined by the State.

A system that chooses to first test for

total coliforms in the source water, and

then test any total coliform-positive

culture for E. coli would meet the

requirement.

If any sample is E. coli-positive,

coliphage-positive or enterococcipositive, the system would be required

to meet § 141.404. EPA believes that a

total coliform-positive sample in the

distribution system, followed by a fecal

indicator-positive sample in the source

water, indicates a serious contamination

problem.

The Agency would allow the State to

waive source water monitoring for any

system, on a case-by-case basis, if the

State determines that the total coliformpositive is associated solely with a

distribution system problem. In this

case, a State official would be required

to document the decision, including the

rationale for this decision, in writing,

and sign the document.

c. Confirmation of Positive Source

Water Sample

The Agency recognizes that falsepositive results may occasionally occur

with most microbial methods (i.e., a

non-target microbe is identified by the

method as a target microbe). For

example, the false-positive rate for E.

coli is 7.2% for the E*Colite Test, 2.5%

for the ColiBlue24 Test, and 4.3% for

the membrane filter test using MI Agar.

Therefore, EPA would allow the State

to invalidate a positive source water

sample where a laboratory establishes

that improper sample analyses caused

the positive result or if the State has

substantial grounds to believe that a

positive result was due to a

circumstance or condition that did not

reflect source water quality and

documents this in writing. For example,

a State may invalidate a positive source

water sample if a subsequent validation

step for the same sample fails to confirm

the presence of the fecal indicator being

used. These provisions are consistent

with the invalidation criteria under the

TCR (40 CFR 141.21(c)).

EPA believes that, in the interest of

public health, a positive sample by any

of the methods listed in Table III–4

should be regarded as a fecal indicatorpositive source water sample. This

assumption is supported by the Pipes

and Christian study (Pipes and

Christian, 1982) study mentioned

previously, which shows that sample

collector handling error is rarely a cause

of fecal contamination. Nevertheless,

the Agency recognizes that

contamination during sampling and

analysis may occur, albeit rarely, and is

proposing to allow the State to

invalidate a fecal indicator-positive in a

routine monitoring sample under

certain circumstances in the manner

described in this section. EPA is also

proposing to allow confirmation of a

fecal indicator-positive routine source

water sample. Specifically, the rule

would permit the State to allow a

system to waive compliance with the

treatment technique in § 141.404, after a

single fecal indicator-positive source

water sample on a case-by-case basis,

if—

(1) The system collects five repeat

source water samples within 24 hours

after being notified of a source waterpositive result;

(2) The system has the samples

analyzed for the same fecal indicator as

the original sample;

(3) All the repeat samples are fecal

indicator-negative; and

(4) All required source water samples

(routine and triggered) during the past

five years were fecal indicator-negative.

Under this approach, a system would

not necessarily have to comply with the

specified treatment requirements on the

basis of a single, isolated fecal indicatorpositive sample if all additional

monitoring showed that no problem

exists. The Agency believes that this

limited level of confirmation would not

undermine public health protection.

Conversely, the Agency believes that

two fecal indicator-positive source

water samples at a site provides strong

evidence that the source water has been

fecally contaminated.

The Agency is also proposing that a

total coliform-positive sample in the

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30231

distribution system accompanied by a

fecal indicator-positive source water

sample be sufficient grounds for

requiring compliance with the treatment

requirements. The Agency argues that it

would be unreasonable to expect a

sample collector to accidently

contaminate two samples taken at least

one day apart, and also contends that

the likelihood of a false-positive result

occurring in both of two samples is

much lower than in a single sample.

Thus, the Agency believes that, in this

circumstance, there is a significant

probability that the source water is

indeed fecally contaminated. Moreover,

the Agency notes that, under the TCR,

two consecutive total coliform-positive

samples, one of which is E. colipositive, is sufficient grounds for an

acute violation of the MCL for total

coliforms. For these reasons, EPA

believes that it is reasonable to require

a system with a total coliform-positive

sample in the distribution system

followed by a fecal indicator-positive

source water sample to comply with the

treatment requirements. However, EPA

also recognizes that, by itself, a positive

total coliform result is not always an

indication of fecal contamination (even

if the sample result is not a false

positive). EPA requests comment on

waiving compliance of the treatment

techniques after a single positive

triggered monitoring source water

sample based upon five negative repeat

samples as described previously in this

section.

4. Analytical Methods

EPA proposes to approve the

following methods (listed in 141.403),

with the sample volume of 100 mL, for

source water monitoring of E. coli,

enterococci and coliphage. A system

would have to use one of these methods.

Most of the proposed analytical

methods for E. coli for source water

monitoring are consensus methods

described in Standard Methods for the

Examination of Water and Wastewater

(19th and 20th ed.). 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. Information about these methods

is available in the Federal Register (63

FR 41134–41143, July 31, 1998; 64 FR

2538–2544, January 14, 1999) and in the

EPAWater Docket. Of the three

enterococci methods, two are consensus

methods in Standard Methods; while

the third (Enterolert) was described in a

peer-reviewed journal article (Budnick

et al., 1996). The description for each of

the proposed E. coli and enterococci

methods state explicitly that the method

is appropriate for fresh waters or

drinking waters.

EPA is proposing the approval of two

newly developed coliphage methods for

detecting fecal contamination.

The Agency has conducted

performance studies on the two

proposed methods, using ten

laboratories: a new two-step enrichment

method and a single-agar layer method

used for decades, but recently optimized

for ground water samples. For the twostep enrichment method, using 100-mL

spiked water samples (reagent water and

ground water) and two E. coli hosts

(CN–13 and Famp), laboratories detected

one plaque-forming unit (PFU) 60–90%

of the time. For the optimized singleagar layer method, using the same water

type and volume (but higher coliphage

spike) and same two E. coli hosts,

recoveries ranged from 61% to 178%,

based upon a coliphage spike level

determined by a standard double-agar

layer test.

Based upon the results of performance

testing, EPA believes that these two

coliphage tests are satisfactory for

monitoring ground water in compliance

with this rule. The two test protocols

and study results are available for

review in EPA’s Water Docket.

EPA is proposing requiring that

systems collect and test at least a 100-

mL sample volume. The Agency

recognizes that a 1–L sample volume

will provide ten times more sensitivity

than a 100-mL sample. However, the

Agency also understands that the greater

sample volume would also weigh ten

times more, and thus cost more to ship

to a laboratory. Data exists that indicate

more frequent smaller-volume samples

are better in detecting fecal

contamination than a smaller number of

high volume samples (Haas,1993).

AWWARF is funding a study on this

issue, and data should be available

shortly. The Agency requests comment

on the most appropriate sample volume.

For any of the methods described

previously, the maximum allowable

time between ground water sample

collection and the initiation of analysis

in the certified laboratory, is 30 hours.

This would be consistent with the TCR.

The Agency would prefer a shorter time,

but believes that a sizable percentage of

small systems have difficulty getting

their samples to a certified laboratory

within 30 hours. In addition, unlike the

SWTR where the density is measured,

EPA is proposing in the GWR to require

analysis for microorganism detection

alone. The Agency believes that the

detection of an organism is less

sensitive to change than measurement of

density, and thus a 30-hour transit time

would be reasonable.

5. Request for Comments

EPA requests comments on proposed

indicators of fecal contamination and

analytical methods. In addition, EPA

requests comments on the following

alternative approaches.

(a) Source Water Samples after an MCL

Violation of the TCR

EPA requests comment on requiring a

system that violates the MCL for total

coliforms, or detects a single fecal

coliform/E. coli-positive sample under

the TCR, to collect five source water

samples, rather than a single source

water sample as proposed. The Agency

believes this alternative approach would

be reasonable, given that both events are

sufficiently important to require the

system to notify the State (and, for a

MCL violation, the public) as opposed

to a single total coliform-positive

sample which does not require

notification. Under this approach,

systems would be required to collect

five source water samples within 24

hours for every MCL violation or

positive E. coli or fecal coliform sample

in the distribution system and test them

for one of the EPA-specified fecal

indicators. If any source water sample

were positive, the system would have to

treat or otherwise protect the drinking

water. This monitoring requirement

would be in addition to requirements

under the TCR.

(b) Sampling of Representative Wells

EPA recognizes that most CWSs have

more than one well, raising the question

about whether the system would need to

monitor all wells or just one

representative well. One approach

would be to require a system to sample

all wells because this approach provides

more reliable public health protection.

However, the Agency notes that wells

belonging to a system may vary in their

sensitivity to fecal contamination.

If a system is drawing water from

more than one well in a

hydrogeologically sensitive aquifer, EPA

believes that all such wells should be

sampled routinely, unless the State can

identify a single representative well or,

the well (or subset of wells) sensitive to

fecal contamination. If a system is

required to collect a source water

sample as a result of a total coliformpositive sample in the distribution

system (triggered monitoring), EPA

believes that all wells should be

sampled, unless the State can identify a

single representative well or the well (or

30232 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

subset of wells) most vulnerable to fecal

contamination. Alternatively, if the total

coliform-positive sample was found in a

part of the distribution system supplied

by a single well, then it might be

acceptable to sample that specific well

alone. The Agency seeks comment on

these alternatives and other approaches.

EPA recognizes that systems may

have storage tanks or other water

holding tanks between the wellhead and

the distribution system. Therefore the

Agency also requests comment on

whether further definition is needed for

exactly where source water samples

should be taken; e.g., at the well, the

tank, or at any point before the water

enters the distribution system. The

Agency seeks comment on where source

water samples should be collected.

(c) Distribution System Monitoring for

Fecal Indicators

One alternative approach for

distribution system monitoring is to

augment total coliform/E. coli testing in

the distribution system with one or

more additional fecal indicators. For

example, under this approach, a system

would be required to monitor coliphage

or enterococci at the same frequency as

it monitors for total coliforms. This

approach recognizes that fecal

indicators differ in their effectiveness in

detecting fecal contamination, and that

this effectiveness may vary with

environmental conditions. Thus, more

than one fecal indicator should stand a

greater likelihood of detecting fecal

contamination than a single indicator

(i.e., E. coli under the TCR). This

approach would be more expensive for

systems, but may be counterbalanced by

the greater likelihood of detecting fecal

contamination. EPA seeks comment on

this monitoring approach.

(d) Persistent Monitoring NonCompliers

EPA requests comment on defining a

persistent non-complier of monitoring

requirements and, specifically what any

additional monitoring, public

notification or treatment requirements

should pertain to them.

(e) Monitoring of Disinfecting Systems

Some States currently require

disinfected systems to monitor their

source water to ensure that the system

would be protected against the potential

risk of fecal contamination in the event

of a disinfectant failure. The Agency

requests comment on requiring a

disinfected system to test its source

water periodically.

The Agency also requests comment on

requiring all ground water systems

(including those that disinfect to 4-log

removal/ inactivation of viruses) to

collect a source water sample after a

total coliform-positive in the

distribution system (triggered

monitoring). Systems may want or need

to change their disinfection practices or

take other source water protection

actions based on discovering that their

source water is contaminated.

(f) Multiple Fecal Indicators

EPA is proposing to require ground

water systems to monitor coliphage, E.

coli, or enterococci, as determined by

the State, in the source water. On March

13, 2000, the Drinking Water Committee

of the Science Advisory Board

(DWCSAB) made a few

recommendations to EPA concerning a

draft of this proposal.

The DWCSAB recommended

unanimously, and the Agency is

requesting comment on, requiring

monitoring for both bacterial and viral

indicators for both routine and triggered

monitoring. Specifically, EPA is

requesting comment on whether

systems that must monitor their source

water be required to monitor for both a

bacterium (E.coli or enterococci) and

virus (male specific and somatic

coliphage). As discussed earlier,

occurrence data show that fecal

indicators differ in their scope and this

may vary with environmental

conditions. The DWCSAB noted that the

scientific literature documents

significant differences between

transport and survival of bacteria and

viruses. Coliphage and human viruses

are smaller than bacterial indicators and

thus under certain conditions may

travel faster through the ground than

bacteria; alternately, bacterial indicators

are often at much higher concentrations

in fecal matter than coliphage, and thus

may be a more sensitive indicator than

coliphage relatively near the

contamination source. The use of both

bacteria and coliphage indicators could

provide better ability to detect fecal

contamination and greater protection of

human health. However it would also

entail a higher probability of false

positive results, and higher sampling

costs to the systems.

The DWCSAB believed that the

proposed indicators (E.coli, enterococci,

and coliphage) are appropriate. The

DWCSAB noted that both E. coli and

enterococci are effective bacterial

indicators. E. coli methods may be more

familiar to many laboratories which may

be advantageous. The enterococci may

be somewhat hardier in terms of

environmental persistence and perhaps

more fecal specific. The media for

enterococci is more selective and less

subject to background growth with

regards to the viral indicators. The

DWCSAB recommended both somatic

and male-specific coliphage be required

when viral monitoring of the source

water is conducted because they will

detect a larger population of coliphage.

The DWCSAB stated that laboratory

methods are available to detect both

coliphages and that they believe that a

method can be made available to detect

both coliphages on a single host (using

a single host such as E. coli C3000) so

that it would not be necessary to collect

and test two samples for coliphage.

(g) Monitoring Frequency and Number

of Samples To Identify Fecal

Contamination

As stated previously, the proposed

rule would require systems with

sensitive wells to conduct monthly

routine monitoring. The Agency

believes that monitoring more

frequently than monthly would increase

the probability for detecting fecal

indicator organisms sooner in a fecally

contaminated well. However, the

Agency also recognizes that more

intensive monitoring could be overly

burdensome to many small systems.

Less than monthly monitoring would

likely delay fecal contamination

detection, and thus continue a possible

health risk for a longer time. EPA

concludes that monthly monitoring is

the most appropriate balance between

monitoring costs and prompt fecal

contamination detection.

The total number of samples needed

to determine whether a ground water is

fecally contaminated depends on the

fecal indicator used, the sample volume,

and the level and duration of fecal

contamination in the source water.

Because the EPA/AWWARF study

described in section II.C.2. monitored

contaminated wells repeatedly, the

results of this study were used to assess

the likelihood (95%, 99%, 99.9%

confidence) of detecting fecal

contamination with different indicators,

number of samples and level of fecal

contamination actually in the ground

water. The Agency then determined the

minimum number of samples necessary

to detect contamination, allowing for a

small percentage of samples where fecal

contamination is not detected. The EPA/

AWWARF study operated in two

phases. In Phase I, the EPA/AWWARF

researchers identified a set of 93 wells

thought to be vulnerable to fecal

contamination. In Phase II, the

researchers conducted further analysis,

including monthly monitoring for virus

and bacteria, on a subset of 23 of the

Phase I wells which demonstrated total

coliform and/or fecal bacteria

contamination and on an additional 7

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30233

wells chosen for their unique physical

or chemical characteristics.

From the wells tested in Phase II of

the EPA/AWWARF study, seven sites

tested positive for enterovirus in at least

one sample of the twelve collected

during the year. These seven waters are

considered to be representative of

ground water that are highly fecally

contaminated at least part of the year. In

such waters, a good indicator should be

present in almost every sample,

therefore, the number of non-detects

should be very low. Combining the

monthly results for these seven waters,

there are 84 results for each indicator.

Table III–5 shows the proportion of

positives among the 84 results for each

of four indicators.

TABLE III–5.—INDICATOR PERFORMANCE IN SEVEN HIGHLY-CONTAMINATED WATERS

Indicator

Samples

positive

(percent)

(N=84)

E. coli ........................................ 50

Enterococci ............................... 54.8

Somatic Coliphage ................... 71.4

F-Specific Coliphage ................ 32.1

N = number of samples.

If P is the probability of a positive

sampling result (a detect) for a single

indicator sample assay, then the

probability of at least one positive result

for N repeated independent samples is

1–(1–P)N. The probability of ‘‘N’’ nondetects is (1–P)N.. Table III–6 shows the

probabilities of ‘‘N’’ non-detects for the

same indicators as a function of the

number of independent sample assays

(N).

TABLE III–6.—PROBABILITY OF NON-DETECTS IN GROUND WATER THAT IS HIGHLY FECALLY CONTAMINATED AT LEAST

PART OF THE YEAR (WHERE ‘N’ IS THE NUMBER OF INDEPENDENT ASSAYS)

Indicator 1

Number of samples (N)

N = 1

(percent)

N = 2

(percent)

N = 4

(percent)

N = 6

(percent)

N = 12

(percent)

N = 24

(percent)

N*

5

percent

N*1

1

percent

N*

0.1

percent

E.coli ............................................ 50 25 6.3 1.6 <0.1 <0.1 5 7 10

Enterococci .................................. 45.2 20.5 4.2 0.9 <0.1 <0.1 4 6 9

Somatic Coliphage ....................... 28.6 8.2 0.7 0.1 <0.1 <0.1 3 4 6

F-Specific Coliphage .................... 67.9 46 21.2 9.8 <1.0 <0.1 8 12 18

Sample volume was 300 ml for E. coli and enterococci, 10–100L for coliphage

N* = Smallest number of samples for which the error rate is less than or equal to the specified percentage (5%, 1%, 0.1%).

Table III–6 shows that six to18 source

water samples are needed, depending

on the fecal indicator (and sample

volume used), to determine with a

99.9% probability that a fecal indicator

positive will be detected in ground

water that is highly contaminated at

least part of the year.

A similar analysis was conducted

using the results for the 10 waters that

tested positive for E. coli at least once

(N=12), but negative for enterovirus.

These waters were defined as

moderately contaminated during at least

part of the year. Because these waters

probably do not contain enteroviruses at

easily detectable levels, the incidence of

waterborne disease is probably less.

Table III–7 shows the probabilities of

‘‘N’’ non-detects for different numbers

of independent sample assays (N).

TABLE III–7.—PROBABILITY OF NON-DETECTS IN GROUND WATER THAT IS MODERATELY FECALLY CONTAMINATED AT

LEAST PART OF THE YEAR (WHERE ‘N’ IS THE NUMBER OF INDEPENDENT ASSAYS)

Indicator

Number of samples (N)

N = 1

(percent)

N = 2

(percent)

N = 4

(percent)

N = 6

(percent)

N = 12

(percent)

N = 24

(percent)

N*

5

percent

N*

1

percent

N*

0.1

percent

E.coli ............................................ 71.7 51.4 26.4 13.5 1.8 <0.1 9 14 21

Enterococci .................................. 67.5 45.6 20.8 9.55 0.9 <0.1 8 12 18

Somatic ........................................ 72.5 52.6 27.6 14.5 2.1 <0.1 10 15 22

F-Specific ..................................... 96.7 93.4 87.3 81.6 66.6 44.3 89 136 204

Sample volume was 300 ml for E. coli and enterococci, 10–100L for coliphage

N* = Smallest number of samples for which the error rate is less than or equal to 5.0%, 1% and 0.1%.

Table III–7, shows that 8 to 89

samples are needed, depending on the

indicator selected, to determine with a

95% probability that a fecal indicator

positive will be detected in a well that

is moderately contaminated at least part

of the year.

Based on the data described

previously and statistics, EPA concludes

that, given a margin of safety for the

analysis, 12 samples would be sufficient

for determining the presence of fecal

contamination in sensitive wells. For

systems operating year round, 12

monthly samples will provide data

throughout the year, increasing the

likelihood of detecting the seasonal

presence of fecal contamination.

EPA requests comment on the

monitoring approach discussed

previously and the analysis and the

assumptions used.

(h) Triggered Monitoring in Systems

Without a Distribution System

EPA believes that circumstances exist

that might not require the collection of

a source water sample after a total

coliform-positive sample in the

distribution system. For example, if an

30234 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

undisinfected system does not have a

distribution system, any sample taken

for compliance with the TCR is

essentially a source water sample.

Therefore, the Agency is requesting

comment on whether to allow States to

waive ‘‘triggered’’ source water

sampling for systems without

distribution systems if the system is also

taking TCR samples at least quarterly. If

the total coliform-positive sample from

the distribution system is fecal coliformor E. coli-positive, the system would be

required to meet the treatment

technique. There might also be

provisions for repeat sampling in this

case.

(i) Routine Monitoring in Systems

Without a Distribution System.

EPA requests comment on whether to

allow States to substitute TCR

monitoring for routine monitoring in

hydrogeologically sensitive systems if

the system does not have a distribution

system and takes at least one total

coliform sample per month under the

TCR for every month it provides water

to the public. Such a system would be

monitoring source water under the TCR.

The State would be allowed to reduce

or waive monthly monitoring after

twelve negative monthly samples. The

rule would require a system that has a

total coliform-positive sample that is

also E. coli (or fecal coliform)-positive to

meet the treatment requirements in

§ 141.404.

(j) Source Water Monitoring for All

Systems

EPA is proposing to require source

water monitoring requirements for

systems that do not treat to 4-log

inactivation or removal of viruses and

have either a total coliform-positive

sample taken in compliance with the

TCR, or any system identified by the

State as hydrogeologically sensitive. On

March 13, 2000 the Drinking Water

Committee of the Science Advisory

Board (DWCSAB) reviewed this issue

and made several recommendations to

EPA concerning a draft of this proposal.

The DWCSAB raised concerns that

under this approach many untreated

ground water systems will not be

monitored at the source, particularly in

light of available occurrence data

indicating contamination between 4 and

31 percent of ground water systems, a

number of which many not be located

in hydrogeologically sensitive areas.

DWCSAB unanimously recommended

that all ground water systems monitor

for both bacterial and viral indicators.

EPA requests comment on whether

routine source water samples should be

required for all ground water systems

that do not notify the State that they

achieved 4-log inactivation or removal

of virus. EPA also requests comment

upon the appropriate frequency

(monthly or quarterly) for routine

monitoring if it were required for all

systems. EPA also requests comment

upon whether this monitoring should be

performed in conjunction with sanitary

surveys so as to provide data for the

sanitary survey and to reduce the

capacity burden on laboratories by

taking advantage of the phased timing of

sanitary surveys (every 3 years for CWSs

and every 5 years for NCWs).

E. Treatment Techniques for Systems

With Fecally Contaminated Source

Water or Uncorrected Significant

Deficiencies

1. Overview and Purpose

EPA proposes that a public ground

water system with uncorrected

significant deficiencies or fecally

contaminated source water must apply

a treatment technique or develop

application for a longer State-approved

treatment technique within 90 days of

notification of the problem. Under the

SDWA, the State may extend the 90 day

deadline up to two additional years if

the State determines that additional

time is necessary for capital

improvements (SDWA, 1412(b)(10)). As

part of this requirement and in

consultation with the State, systems

must eliminate the source of

contamination, correct the significant

deficiency, provide an alternate source

water, or provide a treatment which

reliably achieves at least 99.99 percent

(4-log) inactivation or removal of viruses

before or at the first customer. Ground

water systems which provide 4-log

inactivation or removal of viruses will

be required to conduct compliance

monitoring to demonstrate treatment

effectiveness.

EPA is proposing 99.99% (4-log) virus

inactivation or removal as the minimum

level of treatment since it is the level

required of surface water systems under

the SWTR and because, the World

Health Organization (WHO) states that

disinfection processes must achieve at

least 4-log reduction of enteric viruses

(WHO, 1996). Which treatment

technique approach is chosen will

depend on existing State programs,

policies or regulations. States must

describe in their primacy application

the treatment technique they will

require and under what circumstances.

If the treatment technique is not

provided within 90 days, or if it is not

implemented by the system in

accordance with schedule requirements,

the system is in violation of the

treatment technique requirements of the

GWR.

States and systems can select a

number of treatment technologies to

achieve 4-log virus inactivation or

removal. The treatment technologies

which have demonstrated the ability to

achieve 4-log virus inactivation are

chlorine, chlorine followed by ammonia

(chloramines), chlorine dioxide, ozone,

ultraviolet radiation (UV) and anodic

oxidation. Reverse osmosis (RO) and

nanofiltration (NF) have demonstrated

the ability to achieve 4-log removal of

viruses.

The Agency is also proposing

requirements for systems that treat to

monitor the disinfection and State

notification requirements any time a

system fails to disinfect to 4-log

inactivation or removal of viruses. As

part of this proposal, systems serving

3,300 or more people per day must

monitor the disinfection continuously.

Systems serving fewer than 3,300

people per day must monitor the

disinfection by taking daily grab

samples. When a system continuously

monitors chemical disinfection, the

system must notify the State any time

the residual disinfectant concentration

falls below the State-determined

residual disinfectant concentration and

is not restored within four hours. When

a system monitors chemical disinfection

by taking daily grab samples the system

must maintain the State-determined

residual disinfectant concentration in

all samples taken. If any sample does

not contain the required concentration,

the system must take follow-up samples

every four hours until the required

residual disinfectant concentration is

restored. The system must notify the

State any time the system does not

restore the disinfectant concentration to

the required level within 4 hours.

a. Background

A key element of the multiple-barrier

approach is disinfection where fecal

contamination or significant

deficiencies are not or cannot be

corrected. EPA recognizes that the GWR

must provide system-specific flexibility

due to the diverse configuration and

variability of the numerous public

ground water systems in operation and

allow for State-specific flexibility.

Therefore, the proposed treatment

technique requirements are designed to

support the multiple-barrier approach,

yet provide flexibility to meet systemspecific concerns.

EPA recognizes that States use

varying approaches and that a State’s

preferred approach comes from

extensive experience in dealing with

uncorrected significant deficiencies and

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30235

contaminated source water. States may

require systems to take differing

approaches to providing treatment

techniques, depending upon many

factors, including the system’s

configuration, or State policies or

regulations. Therefore, the proposed

GWR attempts to build on the strengths

of existing State programs, yet provide

requirements which ensure safe

drinking water for all consumers. Under

the proposed GWR, States may require

systems to eliminate the source of

contamination, correct the significant

deficiency, provide an alternate source

water, or provide a treatment which

reliably achieves at least 99.99 percent

(4-log) inactivation or removal of viruses

before or at the first customer. Ground

water systems which provide 4-log

inactivation or removal of viruses will

be required to conduct compliance

monitoring to demonstrate treatment

effectiveness. For example, a State may

have a policy or regulation requiring a

system to consider an alternative source

of safe drinking water before

considering the use of disinfection.

Alternatively, the State may require the

system to disinfect to 4-log virus

inactivation without first considering

the use of corrective BMPs or alternative

sources of safe drinking water. The

approach the State will use to require a

treatment technique for uncorrected

significant deficiencies or fecally

contaminated source water must be

described in the State’s primary

enforcement application (primacy). EPA

expects a State to build upon existing

ground water programs to meet today’s

proposed regulations. In any case,

systems which do not provide the

appropriate State-determined treatment

technique within the 90 day deadline,

and do not have a State-approved plan

in place for complying with the

treatment technique requirement within

90 days, are in violation of the treatment

technique requirements of the GWR.

b. Corrective Action Background

Information

This section presents background

information used by EPA to develop the

proposed treatment technique

requirements for ground water systems

with uncorrected sanitary survey

significant deficiencies or fecally

contaminated source water. Specifically

discussed is information related to

current State treatment technique

requirements, and the protectiveness of

treatment techniques, as well as a

discussion of disinfection as it relates to

uncorrected significant deficiencies and

fecally contaminated source water.

i. Alternative Sources of Safe Drinking

Water

Limited data exists on the

effectiveness of systems using an

alternative source as a treatment

technique against uncorrected

significant deficiencies or fecally

contaminated source water. However,

since many States require a wide range

of BMPs to be followed prior to placing

an alternative source into service, it is

believed that this treatment technique

would be effective. In addition, some

States require the local hydrogeology or

sources of contamination to be

considered for all new sources of

drinking water, and would, therefore,

provide some assurance that an

alternative source as a treatment

technique is effective. Several States

require systems with source water

contamination to provide an alternative

source, if possible.

ii. Background Information on

Eliminating the Source of

Contamination

As with the effectiveness of providing

alternative source water as a treatment

technique for uncorrected significant

deficiencies or fecally contaminated

source water, limited data exists on the

effectiveness of eliminating the source

of contamination as a treatment

technique. The report on the Analysis of

Best Management Practices for

Community Ground Water Systems

Survey Data Collected by the

Association of State Drinking Water

Administrators (ASDWA, 1998)

provides information on the

effectiveness of BMPs in reducing total

coliform positives, however, it does not

address those BMPs used in response to

a source water fecal contamination

event. The report does show that when

correcting significant deficiencies, a

significant pairwise association exists in

reducing both total and fecal coliform

positive samples. A wide range of State

requirements exist for the use of BMPs,

with some States requiring the use of

one or more BMPs in response to

contamination events.

iii. Disinfection

Under today’s proposal, disinfection

is defined as the inactivation or removal

of fecal microbial contamination. As

noted earlier, corrective actions to met

the GWR treatment technique includes

disinfection. Chemical disinfection of

viruses involves providing a dosage of a

disinfectant for a period of time for the

purposes of inactivating the viruses. For

most treatment strategies, the level of

inactivation achieved varies depending

on the target microorganism, residual

disinfectant concentration, ground

water temperature and pH, water quality

and the contact time. The CT value is

the residual disinfectant concentration

multiplied by the contact time.

Specifically, the contact time is the time

in minutes it takes the water to move

between the point of disinfectant

application and a point before or at the

first customer during peak hourly flow.

The concentration is the residual

disinfectant concentration in mg/L

before or at the first customer, but at or

after the point the contact time is

measured. A system compares the CT

value achieved to the published CT

value for a given level of treatment (e.g.,

4-log inactivation of viruses) to

determine the level of treatment

attained. As long as the CT value

achieved by the system meets or

exceeds the CT value needed to

inactivate viruses to 4-log, the system

meets the treatment technique

requirement.

Four-log virus inactivation can also be

achieved by UV disinfection, which

differs from some other treatment

technologies, in that providing a

residual concentration is not possible.

When using UV disinfection, a light

dosage is applied to the water to target

the attainment of IT values (measured in

mWs/cm 2). IT is the light irradiance

(measured in mW/cm 2) to which the

target organisms are exposed, multiplied

by the time for which the irradiance is

applied (measured in seconds). A

system compares the IT value achieved

to the published IT value for a given

level of treatment (e.g., 4-log

inactivation of viruses) to determine the

level of treatment attained. Systems

required to disinfect with UV

disinfection under the GWR must

provide 4-log inactivation of viruses at

a minimum. As long as the system

attains IT values necessary for 4-log

virus inactivation, the system meets the

treatment technique requirement.

Removal, in the context of treatment

of microbially contaminated ground

water, is the physical straining of the

microbial contamination, and is usually

accomplished through filtration. For the

purposes of disinfection of microbially

contaminated ground water, removal is

accomplished by membrane processes.

Membrane processes physically remove

viruses from the water based on the size

of the virus and the size of the

membrane’s pores. When the absolute

size of the membrane’s pores (the

molecular weight cut-off, or MWCO) are

substantially smaller than the diameter

of the virus, removal of the virus can be

achieved. Therefore, membrane

filtration technologies with MWCO

substantially less than the diameter of

30236 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

viruses can be effective treatment

technologies for 4-log virus removal.

iv. State Requirements

EPA used the Baseline Profile

Document for the Ground Water Rule

(USEPA, 1999f) to assess current State

treatment technique requirements. The

EPA survey Ground Water Disinfection

and Protective Practices in the United

States (US EPA, 1996a) was used where

the Baseline Profile Document for the

Ground Water Rule (USEPA, 1999f)

lacked certain information. These data

are important in illustrating the wide

range of State requirements that exists

in ground water systems. The GWR

attempts to build on existing State

practices and provide State flexibility to

address system-specific concerns.

Based on an analysis of information in

the Baseline Profile Document for the

Ground Water Rule (USEPA, 1999f),

there is great variability nationwide in

State statutes, regulations, and policies

for when and how systems must apply

treatment techniques. The variability

ranges from 11 States requiring acrossthe-board disinfection, several other

States requiring systems to attempt to

eliminate the real or potential source of

fecal contamination before considering

disinfection, to some States requiring

systems with fecally contaminated

source water to provide an alternative

source of safe drinking water. Almost all

of the States have statutes, regulations,

or policies for treatment techniques that

define under what circumstances

treatment techniques are necessary.

Twenty-eight of the 39 States which do

not require across-the-board disinfection

require application of treatment

techniques based on the microbial

quality of the water and 12 of the 39

require application of treatment

techniques based on the sanitary quality

of the system.

How a system applies treatment

techniques also varies considerably

from State to State. For example, 36 of

the 50 States specify requirements on

the use of disinfectant residuals in the

distribution system, while five States

require 4-log inactivation of viruses at

the source.

v. Disinfection Technologies

In ground water systems, 4-log

inactivation of viruses can be

accomplished by disinfection with free

chlorine, chloramines, chlorine dioxide,

ozone, on-site oxidant generation

(anodic oxidation) or ultraviolet

radiation (UV). Reverse osmosis (RO)

and nanofiltration (NF) can achieve 4-

log removal of viruses. Chlorine,

chloramines, chlorine dioxide, ozone,

UV, RO and NF are all listed as small

system compliance technologies for the

SWTR. EPA also suggests that small

systems consider on-site oxidant

generation for SWTR compliance

purposes (US EPA, 1998c).

Chemical disinfection technologies

are commonly used to provide

disinfection prior to distribution, and

must attain specific CT values (which

vary depending on the technology) to

achieve 4-log virus inactivation. Free

chlorine disinfection is the most

commonly practiced chemical

disinfection technology, and requires a

CT value of four to provide 4-log

inactivation of viruses at a water

temperature of 15°C, and a pH of 6–9

(USEPA, 1991a).

The required CT values for 4-log virus

inactivation when using chloramines or

chlorine dioxide are higher than when

using free chlorine (Table III–8). The CT

values for 4-log inactivation of viruses at

a pH of 6–9 and a temperature of 15°C

are 16.7 mg-min/L for chlorine dioxide

and 994 mg-min/L for chloramines (US

EPA, 1991a). The CT value for

chloramines applies to systems which

generate chloramines by the addition of

free chlorine, followed by the addition

of ammonia. This chloramine CT value

for 15°C was obtained by extrapolating

CT values from a study performed by

Sobsey, et al, (1988) at 5°C. These CT

values for chlorine and chloramines

studied HAV, which, compared to other

viruses which occur in fecally

contaminated ground water, is relatively

resistant to chlorine disinfection. The

CT value for chlorine dioxide was

obtained from a study of chlorine

dioxide inactivation of HAV by chlorine

dioxide at 5°C (Sobsey, et al., 1988). The

CT value obtained in this study was

adjusted to 15°C, and had a safety factor

of two applied. Considering that

chlorine dioxide has a higher CT value

than chlorine and due to site specific

situations, chlorine dioxide may not be

a feasible disinfection technology for all

systems. Additional studies have been

conducted using free chlorine on

Coxsackie virus B5 and poliovirus 1

(Kelly and Sanderson, 1958), and

information on these studies is provided

in Table III–8. Although the CT values

for HAV were included in the guidance

manual to the SWTR intended for

surface water systems, the CT values are

applicable to ground water systems,

since they are based on disinfectant

residual (i.e., after demand)

concentrations.

Many systems apply free chlorine

disinfection in a contact basin prior to

distribution for virus inactivation,

followed by ammonia addition prior to

distribution (to form chloramines) to

protect the water as it travels through

the distribution system, since

chloramines provide a longer lasting

residual than free chlorine. Due to the

high CT value for chloramines, some

additional disinfection prior to

distribution would probably be needed.

A system that must disinfect may also

need to increase the CT value attained

if the CT value attained does not

achieve the 4-log inactivation of viruses.

Under some circumstances, this can be

accomplished by providing a higher

disinfectant dosage (and hence, a higher

disinfectant residual), or a longer

contact time (by providing additional

storage). Data from the CWSS (1995)

suggests that many CWSs (and some

NCWSs) served by ground water may

already have storage in place and may

be able to achieve 4-log virus

inactivation without additional storage.

According to the CWSS, 59% of

community ground water systems have

distribution system storage tanks,

including 34% of systems serving less

than 100 people (CWSS, 1995). This

number increases to 95% for systems

serving 10,001–100,000 people. Twentyeight percent of ancillary community

ground water systems were found to

have storage. According to the CWSS,

ancillary systems are those systems for

which providing drinking water is not

their primary business (e.g.,

restaurants).

TABLE III–8. DISINFECTION STUDIES USING CHLORINE, CHLORINE DIOXIDE AND CHLORAMINES ON VIRUSES

Studies conducted Effectiveness Additional notes

Disinfectant Virus studied Reference & date Log

removal CT Residual Comments

Chlorine .......................... HAV ................................ Sobsey et al., 1988 ........ 4 1 4 Y safety factor = 3

Sobsey et al., 1988 ........ 4 1 30 Y pH = 10 safety factor = 3

Coxsackie B5 ................. Kelly & Sanderson, 1958 4 ∼1.07 Y pH = 6, T = 28°C

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30237

TABLE III–8. DISINFECTION STUDIES USING CHLORINE, CHLORINE DIOXIDE AND CHLORAMINES ON VIRUSES—Continued

Studies conducted Effectiveness Additional notes

Disinfectant Virus studied Reference & date Log

removal CT Residual Comments

1Poliovirus ..................... Kelly & Sanderson, 1958 4 ∼7.8 Y 4-log at 5°C

Chloramine ..................... HAV ................................ Sobsey et al., 1988 ........ 4 1 994 Y 2 Chlorine dioxide ........... HAV ................................ Sobsey et al., 1988 ........ 4 1 16.7 Y safety factor = 2

1 CT values are for 15°C and a pH of 6–9, unless otherwise noted. 2Table adapted from Technologies and Costs for Ground Water Disinfection (USEPA, 1993).

Ozone, unlike chlorine dioxide and

chloramines, is a stronger disinfectant

than chlorine and would require less

contact time (and less storage) at a

similar dosage (Table III–9) to inactivate

viruses. The CT value for 4-log

inactivation of HAV using ozone is 0.6

mg-min/L at a pH of 6–9 and a

temperature of 15°C (US EPA, 1991a).

The CT data for ozone were obtained

from a study by Roy et al., (1982). This

study obtained data for 2-log

inactivation of poliovirus 1 at 5°C. The

CT value for 4-log virus inactivation

listed in Table III–8 is an extrapolation

of the 2-log inactivation value assuming

first-order kinetics, as well as an

adjustment for inactivation at 15°C. In

addition, a safety factor of three was

applied to the CT values. However, the

CT value required for 4-log virus

inactivation may depend on the virus.

Poliovirus 1 (Kaneko, 1989) and enteric

viruses (Finch et al., 1992) have

demonstrated other CT requirements in

studies; however, it is uncertain

whether or not all other experimental

conditions were the same (e.g.,

temperature) .

Numerous studies on viral

inactivation using UV have been

conducted, with Table III–9 presenting

some of the findings. According to these

studies, 4-log UV disinfection of HAV

requires an IT of between 16 mWs/cm 2

(Battigelli et. al., 1993) and 39.4 mWs/

cm2 (Wilson et al., 1992). IT is the UV

light irradiance multiplied by the

contact time. Other studies have shown

variable IT values, depending on the

virus studied (Table III–9). Harris et al.

(1987) found that an IT of 120 mWs/

cm 2 (including a safety factor of 3) was

required for 4-log inactivation of

poliovirus. Unlike many of the other

alternative treatment technologies, the

efficacy of UV disinfection is not

dependent on the temperature and pH.

TABLE III–9.—DISINFECTION STUDIES USING OZONE, MEMBRANE FILTERS AND UV ON VIRUSES

Studies conducted Effectiveness Additional notes

Disinfectant Virus studied Reference E & date Log removal CT Residual Comments

4Ozone .................. Poliovirus ............... Roy et al.,1982 ...... 4 ............................. 1 0.6 ........................ N safety factor = 3.

Poliovirus ............... Herbold et al.,1989 4–6 ......................... .008 ........................ N T = 10°C.

Kaneko, 1989 ........ 4 ............................. 5 ............................. N

enterics .................. Finch et al.,1992 .... 4 ............................. 3 ............................. N

HAV ....................... Hall & Sobsey,

1993.

3.9–6.0 ................... 0.167 ...................... N Also MS2.

Herbold et al.,1989 4–6 ......................... 0.22 ........................ N T = 10°C.

Vaughn et al,1990 4 ............................. 0.40 ........................ N T = 4°C.

MS2 ....................... Finch et al.,1992 .... 2.7–7 ...................... 7.2 .......................... N T = 22°C.

Finch et al.,1992 .... 4 ............................. .013 ........................ N T = 22°C.

RO .......................... <0.5 nm .................. Jacangelo et

al.,1995.

2 100% removal ...... 50–70% recovery ... N MWCO<0.5 nm.

MS2 ....................... Adham et al.,1998 1.4–7.4 ................... N/A ......................... N

NF .......................... ∼0.5–13 nm ............ US EPA, 1993 ....... 2 100% removal ...... 60–80% recovery ... N MWCO 200–400

Daltons.

UV3 4 ...................... MS2 ....................... Snicer et al.,1996 ... 4 ............................. 87.4–93 .................. N Ground water.

Roessler & Severin,

1996.

4 ............................. ∼63 ......................... N

HAV ....................... Wiedenmann et

al.,1993.

4 ............................. ∼20 N

Battigelli et al.,1993 4 ............................. 16 ........................... N

Wilson et al.,1992 .. 4 ............................. 39.4 ........................ N Also Rota SA11,

Poliovirus 1. 3 4 UV continued ..... Rotavirus ................ Roessler & Severin,

1996.

4 ............................. ∼25 ......................... N

Poliovirus ............... Harris et al.,1987 ... 4 ............................. 120 ......................... N Safety factor = 3.

Chang et al.,1985 .. 3–4 ......................... ∼30 ......................... N

Rotavirus SA11 ...... Battigelli et al.,1993 4 ............................. 42 ........................... N Approximately 4-

log.

Chang et al.,1985 .. 3–4 ......................... ∼30 ......................... N

Coxsackie B5 ......... Battigelli et al.,1993 4 ............................. 29 ........................... N Approximately 4-

log.

1 CT values are values for 15 °C and a pH of 6–9, unless otherwise noted. 2 Removal based on pore size.

3 Inactivation measured by IT, rather than CT. IT is the UV irradiance multiplied by the contact time.

4Table adapted from Technologies and Costs for Ground Water Disinfection (USEPA, 1993)

30238 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

When systems use anodic oxidation

the primary disinfectant generated is

free chlorine. Therefore, the CT value

for anodic oxidation is the same as free

chlorine (Table III–8). However, when

using anodic oxidation other

disinfectants are also generated, and

data suggests that the combined effects

of these disinfectants are stronger than

that of free chlorine alone; however, this

effect has not been substantiated.

Removal as a ground water treatment

technique provides public health

protection through physical filtering of

water using membrane processes. The

effectiveness of a particular membrane

technology depends on the size of the

target organism and the size of the

membrane’s pores (Table III–9).

Membrane filters achieve removals

when the MWCO of the filter is

significantly smaller than the diameter

of the target organism. Viruses range in

diameter from approximately 20–900

nm and may be effectively removed

using reverse osmosis (RO) and

nanofiltration (NF), having MWCOs of

approximately 5 nm and 30 nm,

respectively. Those technologies which

provide removal of microbial

contamination cannot provide a

disinfectant residual, and must be

applied prior to the distribution of the

water.

vi. Free Chlorine in the Distribution

System

Chlorine disinfection is the most

commonly practiced disinfection

technology for microbial contamination

of ground water. Many ground water

systems which practice chlorine

disinfection do so by providing a free

chlorine residual at the entry point to

the distribution system. In general, the

level of inactivation achieved using

disinfectants such as chlorine increases

the longer the disinfectant is in contact

with the water (i.e., contact time). This

is true only when there is an available

supply of chlorine. When the chlorine

dissipates there is no further increase in

the inactivation level. Therefore, when

systems use a chlorine residual at the

entry point to the distribution system,

microbes (including viruses) are

inactivated at varying levels through the

length of the distribution system, and

the risk of illness from pathogens

originating in the source water

decreases with increased travel time

through a well-maintained distribution

system if there is sufficient residual. For

example, if customers at the first service

connection in the water main receive

water disinfected to 4-log virus

inactivation, those customers farther

along the distribution main would

receive water disinfected to levels

greater than 4-logs as long as

disinfectant remains, and no additional

contamination has entered the

distribution system.

EPA conducted analyses to evaluate

the potential effectiveness of a free

chlorine distribution system residual to

provide 4-log inactivation of viruses

originating in the source water. It was

assumed that the customer at the first

service connection received water

disinfected to 4-log virus inactivation.

Preliminary analysis indicates that a

number of ground water systems can

achieve at least 4-log virus inactivation

throughout the distribution system.

Some systems can provide this log

inactivation by maintaining a 0.2 mg/l

free chlorine residual at the entry point

to the distribution system (as required

by the SWTR) and a contact time of 20

minutes prior to the first customer. Data

suggests that as many as 77% of small

community ground water systems (i.e.,

serving less than 10,000 customers) may

achieve 4-log virus inactivation prior to

the first customer during maximum flow

conditions (AWWA, unpublished data

1998). When a ground water system

uses a free chlorine distribution system

residual to disinfect contaminated

source water, the level of virus

inactivation is likely well in excess of 4-

log, especially when taking into account

the time the water awaits usage in the

customers’ piping beyond the service

connection. This extra holding time in

the distribution system increases the CT

value achieved and therefore increases

the log inactivation level achieved. A

system may also need to apply a free

chlorine residual at the entry point to

the distribution system that is higher

than 0.2 mg/L to maintain a detectable

residual throughout the distribution

system, which may lead to higher levels

of virus inactivation. In these instances,

increased levels of protection would be

provided for customers served by all

service connections along the

distribution main. Assuming 4-log virus

inactivation at the first customer, it

could also be assumed that customers at

service connections at later points in the

distribution system would receive water

disinfected to higher levels of

inactivation, in many cases much

higher.

For some systems application of a 0.2

mg/L free chlorine residual at the entry

point to the distribution system and a

detectable free chlorine residual

throughout the distribution system will

not achieve 4-log virus inactivation. In

some cases this will be because the

system does not achieve adequate

contact time, and these systems may

have to increase the contact time by

installing extra distribution system

storage, increasing the free chlorine

residual concentration, adding

supplemental disinfection (such as

disinfection in a contact basin) or

reconfiguring the system. However,

based on 1998 AWWA data, EPA

believes that most ground water CWSs

will have sufficient contact time.

EPA considered requiring systems to

apply a disinfectant residual at the entry

point to the distribution system and

maintain a detectable disinfectant

residual throughout the distribution

system. However, EPA decided against

including it in the proposed GWR since

a disinfectant residual is more accepted

as a distribution system tool than for

controlling source water contamination.

EPA will address the issue of

maintaining a residual in future

rulemaking efforts (e.g. long term 2

ESWTR) as part of a broad discussion on

distribution system issues for all PWSs.

2. Proposed Requirements

EPA proposes the following

requirements for ground water systems

with an uncorrected significant

deficiency or fecally contaminated

source water. The requirements for

treatment techniques, disinfection

monitoring, and notification to ensure

public health protection are addressed.

EPA proposes treatment technique

requirements as one barrier in the

multiple barrier approach. Treatment

techniques contribute to public health

protection by eliminating public

exposure to the source of pathogens,

through eliminating the source of

contamination, requiring the system to

provide an alternative source as the

State deems appropriate, correcting

significant deficiencies that can act as a

potential pathway for contamination, or

disinfection to remove, or inactivate the

microbial contaminants. Information

related to the effectiveness of these

treatment techniques can be found in

the ASDWA BMP study Results and

Analysis of ASDWA Survey of BMPs in

Community Ground Water Systems

(ASDWA, 1998), as well as the SWTR.

a. Treatment Technique Requirements

for Systems With Uncorrected

Significant Deficiencies or Source Water

Contamination

EPA proposes requiring ground water

systems with an uncorrected significant

deficiency or source water

contamination to apply an appropriate

treatment technique, as determined by

the State, within 90 days of detection of

the significant deficiency or source

water contamination. If they cannot

apply an appropriate treatment

technique within that time frame, they

must at a minimum have a StateVerDate 27<APR>2000 17:44 May 09, 2000 Jkt 190000 PO 00000 Frm 00046 Fmt 4701 Sfmt 4702 E:\FR\FM\10MYP2.SGM pfrm08 PsN: 10MYP2
Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30239

approved plan and specific schedule for

doing so. Treatment techniques include:

eliminate the source of contamination,

correct the significant deficiency,

provide an alternate source water, or

provide a treatment which reliably

achieves at least 99.99 percent (4-log)

inactivation or removal of viruses before

or at the first customer. Some treatment

techniques are inappropriate solutions

for the nature of the problem. For

example, a system with contamination

entering the distribution system must

not address the problem by providing

treatment at the source.

Ground water systems which provide

4-log inactivation or removal of viruses

will be required to conduct compliance

monitoring to demonstrate treatment

effectiveness. If a system is unable to

address the significant deficiency

within 90 days, the system must

develop a specific plan and schedule for

providing a treatment technique, submit

the plan and schedule to the State and

receive State approval on the plan and

schedule within the same 90 days. EPA

expects the system to consult with the

State on interim measures to ensure safe

water is provided during the 90 day

correction time frame. During this 90

day period the State and system must

identify and apply a permanent

treatment technique appropriate for that

system, consistent with the State’s

general approach outlined in their

primacy package. If the treatment

technique is not complete within 90

days (or the deadline specified in the

State-approved plan), the system is in

violation of the treatment technique

requirements of the GWR.

b. Disinfection Options

EPA proposes requiring systems that

disinfect due to uncorrected significant

deficiencies or fecally contaminated

source water to provide disinfection

adequate to achieve at least 4-log

inactivation or removal of viruses as

determined by the State. When a system

provides disinfection for uncorrected

significant deficiencies or fecally

contaminated source water, EPA

recommends that the State use EPApublished CT tables to determine what

treatment technologies and what

disinfection parameters are appropriate

for the system. If a system is currently

providing 4-log disinfection and

therefore does not monitor the source

water for fecal indicators, per § 140.403,

then that system must meet the

definition and requirements of

disinfection as described in this section.

c. Monitoring the Effectiveness and

Reliability of Treatment

EPA proposes requiring systems with

uncorrected significant deficiencies or

fecally contaminated source water

under this proposal to monitor the

effectiveness and reliability of

disinfection as follows. This monitoring

must be conducted following the last

point of treatment, but prior to each

point of entry to the distribution system.

Systems serving 3,300 or more people

that chemically disinfect must monitor

(using continuous monitoring

equipment fitted with an alarm) and

maintain the required residual

disinfectant concentration continuously

to ensure that 4-log virus inactivation is

provided every day the system serves

water to the public. EPA recommends

that the State use EPA-developed CT

tables to determine if the system meets

the residual concentration and contact

time requirements necessary to achieve

4-log virus inactivation. As a point of

comparison, the surface water system

size cutoff for systems to measure the

residual disinfectant four or fewer times

per day is 3,300 people served.

Systems serving 3,300 or fewer people

that chemically disinfect must monitor

and maintain the residual disinfectant

concentration every day the system

serves water to the public. The system

will monitor by taking daily grab

samples and measuring for the Statedetermined concentration of

disinfectant to ensure that 4-log virus

inactivation is provided. EPA

recommends that the State use EPAdeveloped CT tables to determine if the

system meets the residual concentration

and contact time requirements

necessary to achieve 4-log virus

inactivation. If the daily grab

measurement falls below the Statedetermined value, the system must take

follow-up samples every four hours

until the required residual disinfectant

concentration is restored.

Systems using UV disinfection must

monitor for and maintain the Stateprescribed UV irradiance level

continuously to ensure that 4-log virus

inactivation is provided every day the

system serves water to the public. EPA

recommends that the State use EPAdeveloped IT tables to determine if the

system meets the irradiance and contact

time requirements necessary to achieve

4-log virus inactivation.

Systems that use membrane filtration

as a treatment technology are assumed

to achieve at least 4-log removal of

viruses when the membrane process is

operated in accordance with Statespecified compliance criteria, or as

provided by EPA, and the integrity of

the membrane is intact. Applicable

membrane filtration technologies are

RO, NF and any membrane filters

developed in the future that have

MWCOs that can achieve 4-log virus

removal.

When monitoring on a continuous

basis, the system must notify the State

any time the residual disinfectant

concentration or irradiance falls below

the State-prescribed level and is not

restored within four hours. This

notification must be made as soon as

possible, but in no case later than the

end of the next business day.

When the system takes daily grab

sample measurements, the system must

notify the State any time the residual

disinfectant concentration falls below

the State-prescribed level and is not

restored within four hours. This

notification must be made as soon as

possible, but in no case later than the

end of the next business day.

Any time a system using membrane

filtration as a treatment technology fails

to operate the process in accordance

with State-specified compliance criteria,

or as provided by EPA, or a failure of

the membrane integrity occurs, and the

compliance operation or integrity is not

restored within four hours, the system

must notify the State. This notification

must be made as soon as possible, but

in no case later than the end of the next

business day.

These requirements are consistent

with those for surface water systems.

Four hours is the cutoff time by which

a surface water system must restore the

free chlorine residual level at entry to

the distribution system to 0.2 mg/L, if

the free chlorine residual at entry to the

distribution system falls below 0.2 mg/

L. In addition, a surface water system

must notify the State anytime the

residual disinfectant entering the

distribution system falls below 0.2 mg/

L and is not restored within 4 hours.

This notification must be made by the

end of the next business day.

EPA proposes that systems which

were required to provide treatment for

uncorrected significant deficiencies or

fecally contaminated source water may

discontinue treatment if the State

determines the need for treatment no

longer exists and documents such a

decision.

d. Eliminating the Source of

Contamination

For systems eliminating the source of

contamination, EPA proposes that the

system and State develop a strategy

using appropriate BMPs considering the

characteristics of the system and the

nature of the significant deficiency or

contamination.

30240 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

e. Reporting Outbreaks

As required in 141.32(a)(iii)(D) for

undisinfected surface water systems;

EPA proposes that if any ground water

system has reason to believe that a

disease outbreak is potentially

attributable to their drinking water, it

must report the outbreak to the State as

soon as possible, but in no case later

than the end of the next business day.

f. Treatment Technique Violations

The GWR proposes the following

three treatment technique violations,

requiring the ground water system to

give public notification:

(a) A ground water system with a

significant deficiency identified by a

State, which does not correct the

deficiency, provide an alternative

source, or provide 4-log inactivation or

removal of viruses within 90 days, or

does not obtain, within the same 90

days, State approval of a plan and

schedule for meeting the treatment

technique requirement, is in violation of

the treatment technique.

(b) A ground water system that detects

fecal contamination in the source water

and does not eliminate the source of

contamination, correct the significant

deficiency, provide an alternate source

water, or provide a treatment which

reliably achieves at least 99.99 percent

(4-log) inactivation or removal of viruses

before or at the first customer within 90

days, or does not obtain within the same

90 days, State approval of a plan for

meeting this treatment technique

requirement, is in violation of the

treatment technique unless the detected

sample is invalidated by the State or the

treatment technique is waived by the

State. Ground water systems which

provide 4-log inactivation or removal of

viruses will be required to conduct

compliance monitoring to demonstrate

treatment effectiveness.

(c) A ground water system which fails

to address either a significant deficiency

as provided in (a) or fecal contamination

as provided in (b) according to the Stateapproved plan, or by the State-approved

deadline, is in violation of the treatment

technique. In addition, a ground water

system which fails to maintain 4-log

inactivation or removal of viruses, once

required, is in violation of the treatment

technique, if the failure is not corrected

within four hours.

EPA requests comment on which (if

any) of these proposed treatment

technique violations should or should

not be treatment technique violations.

EPA also requests comment as to

whether a ground water system which

has a source water sample that is

positive for E. coli, coliphage or

enterococci should be in violation of the

treatment technique.

3. Public Notification

Sections 1414(c)(1) and (c)(2) of the

1996 SDWA, as amended, require that

public water systems notify persons

served when violations of drinking

water standards occur. EPA has recently

(64 FR 25963, May 13, 1999) proposed

to revise the public notification

regulations to incorporate new statutory

provisions enacted under the 1996

SDWA amendments. EPA recently

promulgated the final Public

Notification Rule (PNR), under part 141.

Subsequent EPA drinking water

regulations that affect public

notification requirements will amend

the PNR as a part of each individual

rulemaking. The GWR is proposing Tier

1 (discussed next) public notification

requirements for the treatment

technique violations (see § 141.405).

EPA requests comment on the GWR

public notification requirements.

The purpose of public notification is

to alert customers to 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 public water system 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 proposed 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 regulations

requiring a Tier 1 notice include:

Violation of the TCR, where fecal

contamination is present; nitrate

violations; chlorine dioxide violations;

and other waterborne emergencies. The

State is explicitly authorized to add

other violations and situations to the

Tier 1 list when necessary to protect

public health from short-term exposure.

Tier 2 is for other violations and

situations with potential to have serious

adverse effects on human health. Notice

is required within 30 days, with

extension up to three months at the

discretion of the State or primacy

agency. Violations requiring a Tier 2

notice include all other MCL and

treatment technique violations 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

the monitoring violations.

Today’s regulatory action proposes to

make the presence of a fecal indicator in

a source water sample, failure to

monitor source water and treatment

technique violations as Tier 1 public

notification requirements. Any GWSs

with a violation or situation requiring

Tier 1 public notification must notify

the public within 24 hours of the

violation. GWS’s that must make an

annual CCR report, as discussed in

III.A.7.d., must include any Tier 1

violations or situations in their next

CCR report and include the health

effects language described later in

Appendix B of subpart Q. The following

violations or situations require Tier 1

notice:

(a) A ground water system which has

a source water sample that is positive

for E. coli, coliphage, or enterococci

under § 141.403, unless it is invalidated

under § 141.403(i);

(b) Failure to conduct required

monitoring, including triggered

monitoring when a system has a

positive total coliform sample in the

distribution system and routine

monitoring when the system is

identified by the State as

hydrogeologically sensitive;

(c) A ground water system with a

significant deficiency identified by a

State which does not correct the

deficiency, provide an alternative

source, or provide 4-log inactivation or

removal of viruses within 90 days, or

does not obtain, within the same 90

days, State approval of a plan and

schedule for meeting the treatment

technique requirement in § 141.404;

(d) A ground water system that

detects fecal contamination in the

source water and does not eliminate the

source of contamination, provide an

alternative water source, or provide 4-

log inactivation or removal of viruses

within 90 days, or does not obtain

within the same 90 days, State approval

of a plan for meeting this treatment

technique requirement (unless the

detected sample is invalidated under

§ 141.403(i) or the treatment technique

is waived under § 141.403(j)); and

(e) A ground water system which fails

to address either a significant deficiency

as provided in (c) or fecal contamination

as provided in (d) according to the

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30241

State-approved plan, or by the Stateapproved deadline. (In addition, a

ground water system which fails to

maintain 4-log inactivation or removal

of viruses, once required, is in violation

of the treatment technique if the failure

is not corrected within 4 hours.)

EPA believes that these violations

pose an immediate and serious public

health threat. Fecal contamination is an

acute contaminant and therefore

illnesses and even deaths can occur

through small volumes or short

exposure to fecally contaminated

drinking water. Illnesses can be avoided

by alerting the public immediately. The

proposed tiering requirements under the

GWR are designed to be consistent with

those for the Total Coliform Rule.

Failure to test for fecal coliform or E.

coli when any repeat sample tests

positive for coliform is considered a

Tier 1 violation requiring a Tier 1 notice

under current Public Notification

Regulations. EPA believes that failure to

collect source water samples as

proposed under the GWR poses an

equivalent public health threat to the

failure to test for fecal coliform or E. coli

under the TCR. EPA believes that an

undisinfected ground water system with

either a TC positive in the distribution

system or with a source found to be

hydrogeologically sensitive has an

increased likelihood of microbial

contamination that if not monitored,

presents a public health threat which

requires immediate notice. EPA

acknowledges that in some

circumstances, the hydrogeologic

sensitivity assessment may not be as

indicative of the presence of microbial

contamination in the ground water

system as is the presence of total

coliform in the distribution system.

Given this potential situation, the

Agency requests comment upon

whether the failure to perform routine

source water monitoring should be

considered a lower Tier violation to

avoid alarming the public

unnecessarily. EPA also requests

comment on the other proposed public

notification requirements presented in

this section.

4. Request for Comments

EPA requests comments on all the

information presented earlier and the

potential impacts on public health and

regulatory provisions of the GWR. In

addition, EPA specifically requests

comments on the following alternative

approaches. In particular, EPA requests

comment on the following public health

issues associated with disinfection.

Stakeholders have raised concern about

the potential risk from improperly

managed or applied chemical

disinfectants. Some stakeholders suggest

that requiring small system operators

who may lack training or expertise to

apply chemical disinfection could lead

to collateral health and safety risks. EPA

requests comment on this issue. The

Agency also requests input on

alternative approaches for addressing

demonstrated microbial contamination

and the associated acute microbial

health risks.

Alternative Approaches

a. Distribution System Residuals

EPA requests comment on requiring a

0.2 mg/L free chlorine residual at the

entry points to the distribution system

and a detectable free chlorine residual

throughout the distribution system for

all or some systems (e.g., all systems

serving 3,300 or more people). EPA also

seeks comment on whether or not

systems should be able to use a 0.2 mg/

L free chlorine residual at the entry to,

and detectable throughout, the

distribution system to meet the

disinfection requirements proposed as

part of the GWR.

b. Other Log-Inactivation Levels

EPA seeks comment on the adequacy

of 4-log virus inactivation or removal to

protect public health from fecally

contaminated ground water sources.

Additionally, EPA requests comment on

requiring additional levels of

disinfection under certain

circumstances. For example, increasing

the log virus inactivation may be

appropriate for contaminated systems

with known sources of fecal

contamination in close proximity to a

well.

c. Supplemental Disinfection Strategies

EPA requests comment on whether,

for certain systems with source water

contamination, it may not be possible to

achieve 4-log virus inactivation at the

first customer either because of the

distribution system size or configuration

(e.g., the first customer is relatively

close to the point of disinfectant

application). EPA requests comment on

possible supplemental disinfection

strategies.

d. Mandatory Disinfection for Systems

in Sensitive Hydrogeology

EPA seeks comment on requiring

disinfection for ground water systems

which obtain their water from a

sensitive aquifer regardless of microbial

monitoring results (see section III.B.).

This would provide proactive public

health protection by disinfecting a

sensitive source water before

contamination becomes apparent.

e. Point-of-Entry Devices

EPA seeks comment on EPA

approving the use of point-of-entry

devices to disinfect contaminated

source water. This would allow systems

to provide protection to individual

households, and may be cost-effective

for some very small systems. However,

the system would be responsible for

maintaining the devices and this could

result in significant expenditure of

resources.

f. Across-the-Board Disinfection

EPA seeks comment on requiring all

systems to disinfect, or requiring

disinfection based on system type (e.g.,

CWS), or size of the system (e.g., greater

than 3,300). The SWTR requires all

systems obtaining their water from a

surface water source to disinfect. EPA

notes that 1996 SDWA, as amended

requires that EPA should develop

regulations requiring disinfection for

ground water systems ‘‘as necessary’’.

g. Health and Fiscal Impacts on Small

Systems (i.e., Competing Priorities)

EPA requests comment on whether or

not potential health effects and fiscal

impacts specific for small systems

should be included in the GWR.

Specifically, EPA seeks comment on

what other regulatory priorities will

compete with the GWR and what

implementation issues this will present

(e.g., disinfection under the GWR versus

compliance with the DBPR, difficulty in

obtaining resources for simultaneous

compliance with arsenic, radon, ground

water and DBP regulations).

h. Differing Disinfection Strategies for

Significant Deficiencies and Source

Water Contamination

EPA seeks comment on whether a

different disinfection strategy should be

required depending on whether the

system has an uncorrected significant

deficiencies or fecally contaminated

source water. Under this alternative,

EPA could require systems with

uncorrected significant deficiencies to

provide only a disinfectant residual of

0.2 mg/L free chlorine at entry to the

distribution system, while those systems

with fecally contaminated source water

would be required to provide

disinfection to ensure that the system

achieves 4-log virus inactivation or

removal prior to entry to the

distribution system.

i. Shutting Down Systems With

Uncorrected Significant Deficiencies

EPA seeks comment on whether and

based on what criteria systems with

uncorrected significant deficiencies

should not be allowed to disinfect as a

30242 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

treatment technique, but instead would

not be allowed to serve water to the

public. Under certain circumstances this

approach is used by some States. For

example, disinfection is not an effective

strategy for treating the significant

deficiency of poor distribution system

integrity.

j. Correction Time Frame

EPA requests comment on the criteria

States must use to determine the

adequacy of schedules which go beyond

90 days (e.g., corrections which require

significant capital investments or

external technical expertise).

EPA also requests comment on an

alternative approach for addressing

correction of significant deficiencies.

The alternate approach consists of: (1) A

requirement that the State notify the

system in writing within 30 days of

conducting the sanitary survey listing

the significant deficiency, (2) a

requirement for the system to correct the

significant deficiencies as soon as

possible, but no later than 180 days of

receipt of the letter from the State or in

compliance with a schedule of any

length agreed upon by the State, and (3)

the requirement that the system notify

the State in writing that the significant

deficiencies have been corrected within

10 days after the date of completion.

Under this alternative, a system that

does not correct significant deficiencies

within 180 days or within the time

frames of a schedule agreed upon by the

State is in violation of a treatment

technique and must provide public

notice. The Agency seeks comment on

whether this particular alternative

correction scheme would be appropriate

for the purposes of this rule.

The Agency is also seeking comment

on a second alternative approach for

establishing deadlines to complete

corrective actions of significant

deficiencies. Under this approach,

States, as part of their primacy

requirement to identify and define the

significant deficiencies, may develop

and submit to EPA for approval,

deadlines for the completion of

corrective actions for specific types or

categories of significant deficiencies.

When a specific corrective action is not

implemented within the State deadline,

a State must take appropriate action to

ensure that the system meets the

corrective action requirement. Any

corrective action that extends beyond

180 days to complete, must be

enforceable by the State through a

compliance agreement or an

administrative order or judicial order.

As part of primacy, the State must also

provide a plan for how the State will

meet the time frames established in

their procedures for identifying,

reporting, correcting, and certifying

significant deficiencies within the 180

days. The Agency seeks comment on

whether this alternative correction

scheme might also be appropriate.

k. Required Disinfectant Residual

Concentration

EPA requests comment on requiring

systems that disinfect to maintain a

specified default disinfectant residual

level. This requirement would apply

when the State fails to provide the

system with a State-determined

disinfectant concentration to meet the 4-

log inactivation/removal requirement

within the 90-day correction time frame.

Under this approach, systems that must

treat would be required to maintain a

0.2 mg/L free chlorine residual at entry

to the distribution system and a

detectable free chlorine residual

throughout the distribution system. EPA

also requests comment on other

concentrations of residual free chlorine

to be maintained both at entry to the

distribution system and throughout the

distribution system (e.g., 0.5 mg/L free

chlorine at entry to the distribution

system and 0.2 mg/L free chlorine

throughout the distribution system).

l. Record Keeping for 4-log Inactivation

Requirements

EPA requests comment upon whether

systems which disinfect to comply with

the GWR must maintain records of the

State notification of the proper residual

concentrations (when using chemical

disinfection), irradiance level (when

using UV), or State-specified

compliance criteria (when using

membrane filtrations) needed to achieve

4-log inactivation or removal of virus.

EPA also requests comment on systems

keeping records of the level of

disinfectant residuals maintained, as

well as how long the system should

keep the records (e.g., three years).

These records may be valuable in the

operation of the system because they

will serve as permanent records for

subsequent operators and/or owners of

the ground water system.

m. Differing Monitoring Requirements

for Consecutive Systems

EPA requests comment on any GWR

requirements that should not apply to

consecutive systems. Consecutive

systems are those PWSs that receive

some or all of their water from other

PWSs. Such systems would certainly

need to undergo the proposed sanitary

survey to assure that they are delivering

safe water to their customers. EPA also

requests comment on whether the

hydrogeologic sensitivity assessment

and any corresponding source water

monitoring should be the responsibility

of the water seller or the consecutive

system. EPA requests comments on

whether or not a consecutive system

should be required to monitor treatment

compliance in their distribution system

if the seller has met 4-log inactivation or

removal of viruses. In addition, EPA

requests comment on the selling system

being required to conduct triggered

source water monitoring when the

consecutive system has a total-coliform

positive in the distribution system.

n. State Primacy Requirements

EPA requests comment on the scope

and appropriateness of the GWR State

primacy requirements. The primacy

requirements include the following:

• Sanitary surveys: State will describe

how it will implement the sanitary

survey, including rationales and time

frames for phasing in sanitary surveys,

how it will decide that a CWS has

outstanding performance, and how the

State will utilize data from its SWAPP;

• Hydrogeologic Sensitivity

Assessment: State will identify its

approach to determining the adequacy

of a hydrogeologic barrier, if present;

• Source Water Monitoring: State will

describe its approach and rationale for

determining which of the fecal

indicators (E. Coli, coliphage or

enterococci) ground water systems must

use for routine and/or triggered

monitoring;

• Treatment Techniques: State will

describe treatment techniques,

including how it will provide systems

with the disinfectant concentration (or

irradiance) and contact time required to

achieve 4-log virus inactivation; the

approach the State must use to

determine which specific treatment

option (correcting the deficiency,

eliminating the source of contamination,

providing an alternative source, or

providing 4-log inactivation or removal

of viruses) is appropriate for addressing

significant deficiencies or fecally

contaminated source water and under

what circumstances; and how the State

will consult with ground water systems

regarding the treatment technique

requirements.

o. State Reporting Requirements

The proposed rule contains many

reporting requirements for States to

submit to EPA. EPA requests comment

on the scope and appropriateness of

these reporting requirements. The GWR

reporting requirements include the

following:

• Sanitary Survey: State will report

an annual list of ground water systems

that have had a sanitary survey

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30243

completed during the previous year and

an annual evaluation of the State’s

program for conducting sanitary

surveys.

• Hydrogeologic Sensitivity

Assessment: State will report lists of

ground water systems that have had a

sensitivity assessment completed during

the previous year, those ground water

systems which are sensitive, ground

water systems which are sensitive, but

for which the State has determined that

a hydrogeologic barrier exists, and an

annual evaluation of the State’s program

for conducting hydrogeologic sensitivity

assessments.

• Source Water Monitoring: State will

report an annual list of ground water

systems that have had to test the source

water, a list of determinations of invalid

samples, and a list of waivers of source

water monitoring provided by the State.

• Treatment Techniques: State will

report lists of ground water systems that

have had to meet treatment technique

requirements for significant deficiencies

or contaminated source water,

determinations to discontinue 4-log

inactivation or removal of viruses,

ground water systems that violated the

treatment technique requirements, and

an annual list of ground water systems

that have notified the State that they are

currently providing 4-log inactivation or

removal of viruses.

IV. Implementation

This section describes the regulations

and other procedures and policies States

have to adopt, and the requirements that

public ground water systems would

have to meet to implement today’s

proposal were it to be finalized as

proposed. Also discussed are the

compliance deadlines for these

requirements. States must continue to

meet all other conditions of primacy in

Part 142 and ground water systems must

continue to meet all other applicable

requirements of Part 141.

Section 1413 of the SDWA establishes

requirements that a State or eligible

Indian Tribe must meet to maintain

primary enforcement responsibility

(primacy) for its public water systems.

These include (1) adopting drinking

water regulations that are no less

stringent than Federal NPDWRs in effect

under sections 1412(a) and 1412(b) of

the Act, (2) adopting and implementing

adequate procedures for enforcement,

(3) keeping records and making reports

available on activities that EPA requires

by regulation, (4) issuing variances and

exemptions (if allowed by the State)

under conditions no less stringent than

allowed by sections 1415 and 1416, and

(5) adopting and being capable of

implementing an adequate plan for the

provision of safe drinking water under

emergency situations. 40 CFR part 142 sets out the specific

program implementation requirements

for States to obtain primacy for the

Public Water Supply Supervision

(PWSS) Program, as authorized under

section 1413 of the Act. In addition to

adopting the basic primacy

requirements, States may be required to

adopt special primacy provisions

pertaining to a specific regulation.

These regulation-specific provisions

may be necessary where

implementation of the NPDWR involves

activities beyond those in the generic

rule. States are required by 40 CFR

142.12 to include these regulationspecific provisions in an application for

approval of their program revisions.

These State primacy requirements apply

to today’s proposed rule, along with the

special primacy requirements discussed

next. The proposed regulatory language

under section 142 applies to the States.

The proposed regulatory language in

section 141 applies to the public water

systems. The 1996 SDWA amendments (see

section 1412(b)(10)) provide 3 years

after promulgation for compliance with

new regulatory requirements.

Accordingly, the GWR requirements

that apply to the PWS directly,

specifically requirements found under

section 141 of this proposal (monitoring

and corrective action), are effective

three years after the promulgation date.

The State may, in the case of an

individual system, provide additional

time of up to two years if necessary, for

capital improvements in accordance

with the statute.

Section 1413(a)(1) allows States two

years after promulgation of the final

GWR to adopt drinking water

regulations that are no less stringent

than the final GWR. EPA proposes to

require States to submit their primacy

application concerning the GWR (see

section 142 of the proposed regulatory

language) within two years of the

promulgation of the final GWR and EPA

will review and approve (if appropriate)

the application within 90 days of

submittal (1413(b)(2). This schedule

will provide all States with approved

primacy for the GWR by the three years

after [DATE OF PUBLICATION OF THE

FINAL RULE IN THE FEDERAL

REGISTER].

If the GWR is finalized as proposed

today, the States will have three years

from the effective date (six years from

the GWR promulgation date) to

complete all community water system

sanitary surveys and five years from the

effective date (eight years from the GWR

promulgation date) to complete all noncommunity water system sanitary

surveys. The monitoring and corrective

action requirements would be effective

on the effective date of the final rule

(three years after the GWR promulgation

date).

V. Economic Analysis (Health Risk

Reduction and Cost Analysis)

This section summarizes the Health

Risk Reduction and Cost Analysis in

support of the GWR as required by

section 1412(b)(3)(C) of the 1996 SDWA.

In addition, under Executive Order

12866, Regulatory Planning and Review,

EPA must estimate the costs and

benefits of the GWR in a Regulatory

Impact Analysis (RIA) and submit the

analysis to the Office of Management

and Budget (OMB) in conjunction with

publishing the proposed rule. EPA has

prepared an RIA to comply with the

requirements of this Order and the

SDWA Health Risk Reduction and Cost

Analysis (USEPA, 1999a). The RIA has

been published on the Agency’s web

site, and can be found at http://

www.epa.gov/safewater. The RIA can

also be found in the docket for this

rulemaking (US EPA, 1999a).

The goal of the following section is to

provide an analysis of the costs,

benefits, and other impacts to support

decision making during the

development of the GWR.

A. Overview

The analysis conducted for this rule

quantifies cost and benefits for four

scenarios; the proposed regulatory

option (multi-barrier option), the

sanitary survey option, the sanitary

survey and triggered monitoring option,

and the across-the-board disinfection

option. All options include the sanitary

survey provision. The sanitary survey

option would require the primacy agent

to perform surveys every three to five

years, depending on the type of system.

If any significant deficiency is

identified, a system is required to

correct it. The sanitary survey and

triggered monitoring option adds a

source water fecal indicator monitoring

requirement triggered by a total coliform

positive sample in the distribution

system. The multi-barrier option adds a

hydrogeologic sensitivity assessment to

these elements which, if a system is

found to be sensitive, results in a

routine source water fecal indicator

monitoring requirement. The multibarrier option and the sanitary survey

and triggered monitoring options are

both a targeted regulatory approach

designed to identify wells that are

fecally contaminated or are at a high

risk for contamination. The across-theboard disinfection option would require

all systems to install treatment instead

30244 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

of trying to identify only the high risk

systems; therefore, it has no requirement

for sensitivity assessment or microbial

monitoring.

Costs for each option varied and were

driven by the number of systems that

would need to fix a significant

deficiency or take corrective action,

such as installing treatment or

rehabilitating a well, in response to fecal

contamination. The majority of costs for

all options, with the exception of the

across-the-board option, are the result of

systems having to fix an actual or

potential fecal contamination problem.

The mean annual costs of the various

options range from $73 million to $777

million using a three percent discount

rate and $76 million to $866 million

using a seven percent discount rate.

(Note some costs have not been

quantified and are not included in these

totals, see section V.B.)

These total annual quantified costs

can be compared to the annual

monetized benefits of the GWR. The

annual mean benefits of the various rule

options range from $33 million to $283

million. This result is based on the

quantification of the number of acute

viral illnesses and deaths avoided

attributable to this rule. This rule will

also decrease bacterial illness and death

associated with fecal contamination of

ground water. EPA did not directly

calculate the actual numbers of illness

associated with bacterially

contaminated ground water because the

Agency lacked the necessary bacterial

pathogen occurrence data (e.g., number

of wells contaminated with Salmonella)

to include it in the risk model. However,

in order to monetize the benefit from

reduced bacterial illnesses and deaths

from fecally contaminated ground

water, the Agency used the ratio of viral

and unknown etiology outbreak

illnesses to bacterial outbreak illnesses

reported to CDC for waterborne

outbreaks in ground water systems.

Several non-health benefits from this

rule were also considered by EPA but

were not monetized. The non-health

benefits of this rule include avoided

outbreak response costs (such as the

costs of providing public health

warnings and boiling drinking water),

and possibly the avoided costs of

averting behavior and reduced

uncertainty about drinking water

quality. There are also non-monetized

disbenefits, such as increased exposure

to DBPs.

Additional analysis was conducted by

EPA to look at the incremental impacts

of the various rule options, impacts on

households, benefits from reduction in

co-occurring contaminants, and

increases in risk from other

contaminants. Finally, the Agency

evaluated the uncertainty regarding the

risk, benefits, and cost estimates.

B. Quantifiable and Non-Quantifiable

Costs

In estimating the cost of each rule

option, the Agency considered impacts

on public water systems and on States.

The GWR will result in increased costs

to some PWSs for monitoring, corrective

action of significant deficiencies, and

installing treatment, but these vary

depending on the option. With all rule

options, a greater portion of the

regulatory burden will be placed on

those systems that do not currently

disinfect to a 4-log inactivation of virus.

States will incur costs for an

incremental increase in sanitary survey

requirements, for conducting

hydrogeologic sensitivity assessments,

and for follow-up inspections. Both

systems and States would incur

implementation costs. Some costs of

today’s rule options were not quantified

(such as land acquisition, public

notification costs and corrections to all

potential significant deficiencies (See

section V. B.4.)).

1. Total Annual Costs

In order to calculate the national costs

of compliance, the Agency used a

Monte-Carlo 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

allowed the Agency to capture the

variability in PWS configuration,

current treatment in place and source

water quality.

Table V–1 shows the estimated mean

and range of annual costs for each rule

option. At both a three and seven

percent discount rate for the first three

options, the costs increase as more

components are added for identifying

fecally contaminated wells and wells

vulnerable to fecal contamination. The

fourth option of across-the-board

disinfection is the most costly because

it would require all systems to install

treatment regardless of actual fecal

contamination or the potential to

become fecally contaminated. Costs for

the States to implement these rule

options are also included in the four

cost estimates. Discount rates of three

and seven percent were used to

calculate the annualized value for the

national compliance cost estimate. The

seven percent rate represents the

standard discount rate required by OMB

for benefit-cost analyses of government

programs and regulations.

TABLE V–1.—ANNUAL COSTS OF RULE OPTIONS ($MILLION)

Option

3% Discount

rate

$million

mean

[range]

7% Discount

rate

$million

mean

[range]

Sanitary Survey ....................................................................................................................................................... $73

[$71–$74]

$76

[$74–78]

Sanitary Survey and Triggered Monitoring .............................................................................................................. $158

[$153–$162]

$169

[$163–174]

Multi-barrier (Proposed) Option ............................................................................................................................... $183

[$177–188]

$199

[$192–206]

Across-the-Board Disinfection ................................................................................................................................. $777

[$744–$810]

$866

[$823–$909]

2. System Costs

In order to calculate the cost impact

of each rule option on public water

systems, EPA had to estimate the

current baseline of systems and their

current treatment practices, and then

estimate how many systems would be

affected by the various option

requirements based on national

occurrence information. The industry

baseline discussion is located in section

I.C. of this preamble. Estimates of the

cost compliance requirements for each

rule option are captured in a decision

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30245

tree analysis. The decision tree is

comprised of various percentage

estimates of the number of systems that

will fall into each regulatory component

category. Rule components include

corrective action costs or costs to

address significant deficiencies,

monitoring costs, start-up costs, and

reporting costs. Each of the rule options

contains various combinations of these

rule components with the sanitary

survey option containing the fewest

requirements.

Overall, these rule options provide a

great amount of flexibility, with the

exception of across-the-board

disinfection, and this has complicated

the cost analysis. Data were not always

available to estimate the number of

systems that would fall under the

various rule components. EPA used

data, where available but also consulted

with experts and stakeholders to get the

best possible estimates of the cost of this

rule. More information on the GWR

decision tree and how each element was

estimated can be found in the Appendix

to the GWR RIA (US EPA, 1999a).

As previously mentioned, the main

cost component of the first three rule

options results from systems having to

take corrective action in response to

fecal contamination or to fix significant

deficiencies that could result in well

contamination. In order to analyze the

different rule options, the Agency had to

distinguish between correction of

significant deficiencies and the

corrective actions that result from a

confirmed source water positive sample

for E. coli, enterococci or coliphage. In

addition, it would be extremely

challenging to cost out all conceivable

corrective actions or significant

deficiencies that a system could

potentially encounter. As a result, the

Agency focused on a representative

estimate of potential types of corrective

actions and significant deficiencies as

shown in Table V–2 and Table V–3,

respectively.

The choice of treatment technique (in

consultation with the State) is also

influenced by the size of the system.

This is captured in the decision tree

analysis by assigning probabilities (by

system size) that a certain corrective

action will be chosen. These

probabilities are based on the relative

cost of each action, data on existing

disinfection practices, and best

professional judgment. Additional

significant deficiencies related to

improper treatment were included in

the cost analysis for systems that

currently disinfect. These deficiencies

are also captured in the decision tree

and are listed in Table V–3.

TABLE V–2.—TREATMENT TECHNIQUES

TO ADDRESS POSITIVE SOURCE

WATER SAMPLES

Corrective action: 1

Rehabilitating an existing well

Drilling a new well

Purchasing water (consolidation)

Eliminating known sources of contamination

Installing disinfection (8 choices of technologies)

1 Choice varies with systems size and corrective action feasibility.

Each treatment technique can be

addressed by various low or high cost

alternatives. For example, a lower cost

fix for many systems would be to

rehabilitate a well while a higher cost

fix would be to drill a new well. It is

possible that not all States, in

coordination with systems, would

choose the relatively lower cost

alternative of well rehabilitation. It

would depend on the well itself and

also the problem that was being

addressed. In addition, if the model

predicted that a system would install

treatment, the choice of treatment is

contingent on system size. To capture

these alternative possibilities, the

Agency considered different

combinations of low and high cost

alternatives. For instance, when the low

cost corrective action alternative was

run, the model estimated a greater

percentage of systems choosing the

lower cost well rehabilitation option

versus the higher cost option of drilling

a new well. To account for the

uncertainty in the types of significant

deficiencies identified and in the

treatment technique taken, the cost

model was run for each of the following

combinations of low and high costs

alternatives.

• Low significant deficiency cost/low

treatment technique cost

• Low significant deficiency cost/

high treatment technique cost

• High significant deficiency cost/low

treatment technique cost

• High significant deficiency cost/

high treatment technique cost

These combinations of low and high

cost are reflected in the range of cost

estimates shown in Table V–1 for the

multi-barrier option (proposed option),

the sanitary survey and triggered

monitoring option, and the across-theboard option. For the sanitary survey

option, only the high and low costs

associated with significant deficiencies

were included in the analysis. As stated

earlier, treatment technique costs are the

result of source water monitoring which

is not included with the sanitary survey

option.

TABLE V–3.—SIGNIFICANT

DEFICIENCIES

Significant deficiencies

Unsealed well or inadequate well seal

Improper well construction

Inadequate roofing on a finished water storage tank

Evidence of vandalism at finished water storage tank

Unprotected cross connection in the distribution system

Booster pump station which lacks duplicate

pumps

Additional significant deficiencies for disinfecting systems:

Inadequate disinfection contact time

Inadequate application of treatment chemicals

In addition to the treatment technique

costs, EPA estimated the cost to systems

for monitoring. All options would have

some monitoring costs. However, the

monitoring costs vary depending on the

rule option as indicated in Table V–4.

Regardless of the option, the triggered

and routine monitoring applies only to

systems that do not disinfect to a 4-log

inactivation of virus.

Both the triggered and routine

monitoring costs are calculated based on

the cost of the test and the operator’s

time to take and transport the sample.

EPA assumed that if this source water

sample is positive, all systems would

take five repeat samples to confirm the

positive (although this is an optional

rule component). For routine

monitoring, the Agency assumed that all

systems would monitor their source

water monthly for the first year and

quarterly thereafter at the States’

determination. However, in some cases

the State may allow the system to

discontinue monitoring after 12

monthly samples or it could also require

the system to continue with monthly

monitoring. The cost of disinfectant

compliance monitoring varies with

system size and would be required for

any system that currently disinfects or

installs treatment as a result of the

GWR. For large systems, EPA assumed

that an automated monitoring system

would be installed; for smaller systems,

EPA assumed that a daily grab sample

would be taken. A more detailed

explanation of each of these monitoring

schemes is located in section III. D. and

section III E.2.c.

30246 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

TABLE V–4.—MONITORING

REQUIREMENTS BY RULE OPTION

Option

Triggered

monitoring

Routine

monitoring

Disinfectant

compliance

monitoring

Sanitary Survey ✔

Sanitary Survey

and Triggered

Monitoring

Option ............ ✔ ✔

Multi-barrier

(Proposed)

Option ............ ✔✔✔

Across-the

Board Disinfection Option ................ ✔

Finally, the Agency accounted for a

system’s start-up costs to comply with

the GWR . These costs include time to

read and understand the rule,

mobilization and planning, and training.

EPA assumed start-up costs would

remain constant across the rule options.

The Agency also estimated system costs

for reporting and recordkeeping of any

positive source water samples.

3. State Costs

Similar to the system cost, State costs

also vary by rule option. Depending on

the option, States would face increased

costs from the incremental difference in

the sanitary survey requirements and

frequency, from conducting a one-time

hydrogeologic sensitivity assessments,

and tracking monitoring information for

those options with a monitoring

requirement. States would also have

start-up and annual costs for data

management and training. If a system

needs longer than 90 days to complete

a treatment technique or repair a

significant deficiency, the State would

have to approve the time schedule and

plan.

By including start-up costs, annual

fixed costs, and incremental sanitary

survey costs in the decision tree

analysis for all rule options, EPA

accounted for these State costs. The

analysis also assumed costs for State

review and approval of plans for

treatment techniques. The cost for the

one-time sensitivity assessments is

included for the proposed rule option

analysis.

4. Non-Quantifiable Costs

Although EPA has estimated the cost

of all the rule’s components on drinking

water systems and States, there are some

costs that the Agency did not quantify.

These non-quantifiable costs result from

uncertainties surrounding rule

assumptions and from modeling

assumptions. For example, EPA did not

estimate a cost for systems to acquire

land if they needed to build a treatment

facility or drill a new well. This was not

considered because many systems will

be able to construct new wells or

treatment facilities on land already

owned by the utility. In addition, if the

cost of land was prohibitive, a system

may chose another lower cost

alternative such as connecting to

another source. A cost for systems

choosing this alternative is quantified in

the analysis. The cost estimates do not

include costs for public notification

which are proposed. These estimates

have not been included because EPA

has no data on which to base an

estimate of the number of treatment

techniques violations or the number of

times systems will fail to perform source

water monitoring.

In addition, the Agency did not

develop costs for all conceivable

significant deficiencies or corrective

actions that a system may encounter.

Instead, a representative sample was

chosen as shown in Tables V–2 and V–

3.

C. Quantifiable and Non-Quantifiable

Health and Non-Health Related Benefits

The primary benefits of today’s

proposed rule come from reductions in

the risks of microbial illness from

drinking water. In particular, the GWR

focuses on reducing illness and death

associated with viral infection.

Exposure to waterborne bacterial

pathogens are also reduced by this rule

and the benefits are monetized, but not

by the same method used to calculate

reductions in viral illness and death

because of data limitations. It is likely

that these monetized illness calculations

which are based on a cost of illness

(COI) rather than a willingness to pay

(WTP) approach, underestimate the true

benefit because they do not include pain

and suffering associated with viral and

bacterial illness.

Additional health benefits such as

reduced chronic illness were

investigated, but were not quantified or

monetized in this analysis. Other nonhealth benefits will likely result from

this rule but were also not quantified or

monetized. These non-health related

benefits are discussed in sections V.A.

and V.C. 2.

1. Quantifiable Health Benefits

The benefits analysis focused on

estimating reductions in viral and

bacterial illness and death that would

result from each of the rule options. The

first part of the analysis estimates the

baseline (pre-GWR) level of illness as a

result of microbial contamination of

ground water. A discussion about how

the Agency estimated this baseline risk

is located in section II. E. of today’s

proposal. An important component of

these risk estimates is the effect that

these pathogens have on children

(especially infants) because they are

more likely to have severe illness and

die from viral infection than the general

population. A detailed discussion of

risks to children is located in section VI.

G.

The second part of the analysis

focused on the reduction in risk that

results from the various rule

components. These components include

identifying high risk wells, fixing

significant deficiencies, increased

monitoring for some systems, and

possibly installing treatment in the

event that a problem can not be fixed or

a new source found. To calculate these

changes, the risk-assessment model was

re-run using new assumptions based on

reductions in viral exposure which

results from different levels of fecal

contamination identified by each rule

option.

To model the reduction in source

contamination that would result from

implementation of the four regulatory

options, EPA assumed reductions in the

number of ground water systems/points

of entry that are potentially

contaminated with viral pathogens

under baseline conditions. The

reduction varies with expectations

regarding the effectiveness of each

option in identifying and correcting

significant defects at the source.

Reductions in treatment failure rate and

in distribution system contamination

are also addressed for each option. The

estimated reductions in contamination

which are expected for each rule option

are summarized in Table V–4a. These

estimates are based upon information

from consultations by the Agency with

stakeholders and the Agency’s best

professional judgement regarding the

effectiveness of sanitary surveys and

upon co-occurrence rates of fecal

indicators with pathogenic viruses. See

section 5.3 of the GWR RIA for a

detailed discussion of the basis for the

estimated reductions.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30247

TABLE V–4A. ESTIMATED CONTAMINATION REDUCTIONS FOR GWR OPTIONS

[In Percent]

Regulatory option

Estimated reduction in viral source contamination of undisinfected ground water

sources

Estimated reduction

in rate of disinfection failure for

GWSs with viral

contamination of

the source

Estimated reduction

in distribution system contamination

Properly with virus of GWSs

constructed

Improperly

constructed

Option 1. Sanitary Survey Only ..................................... 0 40–60 0–26 (CWS)

0–43 (NCWS)1

0–25

(NA for TNC) 2

Option 2. Sanitary Survey and Triggered Monitoring .... 30–54 58–82 77–100 0–25

(NA for TNC) 2

Option 3. Multi-Barrier (Proposed) ................................. 38–77 63–91 77–100 0–25

(NA for TNC) 2

Option 4. Across-the-Board Disinfection ........................ 100 100 77–100 0–25

(NA for TNC) 2

1 Non-community water systems (NCWS), both transient and nontransient, have an estimated reduced risk of contamination of 0–43%; community water systems (CWS) reduced risk is 0–26%. 2 Reduction of risk in transient non-community (TNC) systems was not considered.

After the reductions in viral illnesses

and death were estimated, the Agency

estimated the monetized benefit from

the reduction in bacterial illnesses and

death associated with each rule option.

EPA could not directly calculate the

actual numbers of illnesses and death

associated with bacterially

contaminated ground water because the

Agency lacked the necessary pathogen

occurrence information to include it in

the risk model. In order to estimate the

benefit from reducing bacterial illnesses

and deaths from fecally contaminated

ground water, the Agency relied on

CDC’s outbreak data ratio of viral

outbreaks and outbreaks of unknown

etiology believed to be viral to bacterial

outbreaks in ground water. These data

indicate that for every five viral

outbreaks, there is one bacterial

outbreak. It was further assumed that

the cost of these bacterial illnesses

would be comparable to viral illness

estimates.

To assign a monetary value to the

illness, EPA estimated costs-of-illness

ranging from $158 to $19,711 depending

upon the age of the individual and

severity of illness (see Exhibits 5–9 and

5–10 in the RIA). These are considered

lower-bound estimates of actual benefits

because it does not include the pain and

discomfort associated with the illness.

This issue is discussed in greater detail

in the GWR RIA (USEPA, 1999a).

Mortalities were valued using a value of

statistical life estimate (VSL) of $6.3

million consistent with EPA policy. The

VSL estimate is based on a best-fit

distribution of 26 VSL studies and this

distribution has a mean of $4.8 million

per life in 1990 dollars. For this

analysis, EPA updated this number to

1999 dollars which results in a mean

VSL value of $6.3 million. Table V–5

shows the annual monetized benefits by

rule option.

TABLE V–5.—QUANTIFIED AND MONETIZED BENEFITS BY RULE OPTION ($MILLION)

Options

Morbidity

$million

[range]

Mortality

$million

[range]

Total

$million

[range]

Sanitary Survey ................................................................................................... $22

[$7 to $38]

$11

[$2 to $20]

$33

[$9 to $58]

Sanitary Survey and Triggered Monitoring .......................................................... $120

[$100 to $140]

$58

[$47 to $68]

$178

[$147 to $209]

Multi-Barrier Proposed ( Option) ......................................................................... $139

[$115 to $163]

$66

[$54 to $79]

$205

[$169 to $242]

Across-the-Board Disinfection ............................................................................. $192

[$174 to $210]

$91

[$81 to $101]

$283

[$255 to $311]

2. Non-Quantifiable Health and NonHealth Related Benefits

Although viral and some bacterial

illness have been linked to chronic

diseases, insufficient data was available

to forecast the number of avoided

chronic cases that would result from

each rule option. A review of medical

and epidemiological data identified

several chronic diseases linked to viral

infections. The strongest evidence links

Group B coxsackievirus infections with

Type 1-insulin-dependent diabetes and

also to heart disease. Bacterial illness

can also result in longer-term

complications including arthritis,

recurrent colitis, and hemolytic uremic

syndrome. Most of these chronic

illnesses and longer term complications

are extremely costly to treat.

Using cost-of-illness (COI) estimates

instead of willingness-to-pay (WTP)

estimates to monetize the benefit from

illness reduction generally results in

underestimating the actual benefits of

these reductions. In general, the COI

approach is considered a lower bound

estimate of WTP because COI does not

include pain and suffering. EPA

requests comment on the use of an

appropriate WTP study to calculate the

reduction in illness benefits of this rule.

D. Incremental Costs and Benefits

Today’s proposed rule options

represent the incremental costs and

benefits of this rule. Both costs and

benefits increase as more fecal

contamination detection measures are

added to the sanitary surveys for the

first three options. The proposed option

has the highest cost of these three

incremental options, but it also

produces incrementally more benefits.

30248 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

The fourth option, across-the-board

disinfection, is the most costly because

it would require all systems to install

treatment or to upgrade to 4-log

removal/inactivation. It would not

provide the flexibility of the other three

options and would not target

specifically high risk systems. Similar to

the first three options, this option also

includes the sanitary survey provision.

This is included to address problems in

the distribution systems and with

disinfection failure.

Table V–6 and Table V–6a show the

monetized costs, benefits and net

benefits for all four options using both

a three percent and seven percent

discount rate, respectively. It is

important to remember that nonquantified costs and benefits are not

included in these net benefit numbers.

TABLE V–6.—NET BENEFITS—3% DISCOUNT RATE ($MILLION)

Options

Mean annual

costs (3%)

$million

Mean annual

benefits 1

$million

Net benefits of

the

means

$million

Sanitary Survey ........................................................................................................................... $73 $33 ($40)

Sanitary Survey and Triggered Monitoring .................................................................................. 158 178 20

Multi-Barrier (Proposed) .............................................................................................................. 183 205 22

Across-the-board Disinfection ...................................................................................................... 777 283 (494)

1 Does not include non-quantified benefits which would increase the net benefits of these rule options.

TABLE V–6A.—NET BENEFITS—7% DISCOUNT RATE ($MILLION)

Options

Mean annual

costs

(7%)

$million

Mean annual

benefits 1

$million

Net benefits

$million

Sanitary Survey ........................................................................................................................... $76 $33 ($43)

Sanitary Survey and Triggered Monitoring .................................................................................. 169 178 9

Multi-Barrier (Proposed) .............................................................................................................. 199 205 6

Across-the-board Disinfection ...................................................................................................... 866 283 (583)

1 Does not include non-quantified benefits which would increase the net benefits of these rule options.

E. Impacts on Households

Overall, the average annual cost per

household for the first three rule options

are small across most system size

categories as shown in Table V–7.

However, costs are greater for the

smallest size category across all options.

This occurs because there are fewer

households per system to share the cost

of any corrective action or monitoring

incurred by the systems. For example,

under the Multi-Barrier option

household costs would increase by

approximately $5 per month for those

served by the smallest size systems

(<100 people) while those served by the

largest size systems (>100,000 people)

would face only a $0.02 increase in

monthly household costs. As previously

mentioned, the majority of the cost from

the first three rule options is the result

of systems having to correct significant

deficiencies in their systems or to take

corrective action in response to fecal

contamination. On average, household

costs resulting from the first three rule

options increase from $2.45 to $3.86

annually. The most expensive option,

across-the-board disinfection, also has

the highest average household costs at

$19.37 annually.

TABLE V–7.—AVERAGE ANNUAL HOUSEHOLD COST FOR GWR OPTIONS FOR CWS TAKING CORRECTIVE ACTION OR

FIXING SIGNIFICANT DEFECTS

Size categories Sanitary survey option

Sanitary survey and triggered monitoring option

Multi-barrier

option

(proposed)

Across-theboard disinfection option

<100 ................................................................................................................. $29.86 $67.19 $62.48 $191.87

101–500 ........................................................................................................... 11.23 15.02 18.95 81.38

501–1,000 ........................................................................................................ 5.72 6.29 6.25 38.79

1,001–3,300 ..................................................................................................... 2.99 2.91 3.39 23.45

3,301–10,000 ................................................................................................... 1.39 1.46 2.74 16.78

10,001–50,000 ................................................................................................. 0.62 0.59 0.62 4.87

50,001–100,000 ............................................................................................... 0.30 0.70 1.01 10.37

100,001–1,000,000 .......................................................................................... 0.32 0.20 0.27 1.66

Average ............................................................................................................ 2.45 3.34 3.86 19.37

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30249

F. Cost Savings From Simultaneous

Reduction of Co-Occurring

Contaminants

If a system chooses to install

treatment, it may choose a technology

that would also address other drinking

water contaminants. For example, when

using packed tower aeration to treat

radon, it is the accepted engineering

practice, and in some States an existing

requirement, to also install disinfection

treatment for removal of microbial

contaminants introduced in the aeration

treatment process. Depending on the

dosage and contact time, the routine

disinfection would also address possible

or actual fecal contamination in the

source water. If systems had an iron or

manganese problem, the addition of an

oxidant and filtration can 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 is currently in the process

of proposing rules to address radon and

arsenic. Because of the difficulties in

establishing which systems would have

all three problems of fecal

contamination, radon, and arsenic or

any combination of the three, no

estimate was made of the potential cost

savings from addressing more than one

contaminant simultaneously. EPA also

recognizes that while there may be

savings from treating several

contaminants simultaneously relative to

treating each of them separately, there

may also be significant economic

impacts to some systems (especially

small systems), if they have to address

several contaminants in a relatively

short time frame. Because of the lack of

good data on co-occurrence of

contaminants, EPA has not considered

these simultaneous impacts in the

analysis of household and per system

costs.

G. Risk Increases From Other

Contaminants

The RIA for today’s rule contains a

detailed discussion of the increased risk

from other contaminants that may result

from GWR requirements. Most of the

risk stems from currently untreated

systems installing disinfection. When

disinfection is first introduced into a

previously undisinfected system, the

disinfectant can react with pipe scale

causing increased risk from some

contaminants and water quality

problems. Contaminants that may be

released include lead, copper, and

arsenic. It could also lead to a temporary

discoloration of the water as the scale is

loosened from the pipe. These risks can

be reduced by gradually phasing in

disinfection to the system, by routine

flushing of distribution system mains

and by maintaining a proper corrosion

control program.

Using a chlorine-based disinfectant or

ozone 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 and is

currently being further considered by

the Stage II M–DBP FACA. Systems

could avoid this problem by choosing

an alternative disinfection technology

such as ultraviolet disinfection or

membrane filtration, though this may

increase treatment costs. The GWR cost

estimate includes such additional

treatment costs for a portion of systems

taking corrective action.

H. Other Factors: Uncertainty in Risk,

Benefits, and Cost Estimates

Today’s proposal models the current

baseline risk from fecal contamination

in ground water as well as the reduction

in risk and the cost for four rule options.

There is uncertainty in the baseline

number of systems, the risk calculation,

the cost estimates, and the interaction of

other rules currently being developed.

These uncertainties are discussed

further in the following section.

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. Therefore, EPA does

not have a reliable estimate of how

many of these mixed systems exist. To

the extent that systems classified in

SDWS as surface water or ground water

under the influence of surface water

may also have ground water wells not

under the influence of surface water and

thus be subject to this rule, the costs and

benefits estimated here would be

understated. In addition, the SDWIS

data on non-community water systems

does not have a consistent reporting

convention for population served. Some

States may report the population served

over the course of a year, while others

may report the population served on an

average day. Also, SDWIS does not

require States to provide information on

current disinfection practices and, in

some cases, it may overestimate the

daily population served. For example, a

park may report the population served

yearly instead of daily. EPA is looking

at new approaches to address these

issues, and both are discussed in the

Requests for Comment section V.I.

The risk calculations concerning the

baseline number of illnesses and the

reduction of illnesses that results from

the various rule options contains

uncertainty. For example, a nationally

representative study of baseline

microbial occurrence in ground water

does not exist. EPA chose the AWWARF

study (described in section II.C.1) to

represent properly constructed wells

because, of the thirteen available

studies, it is the most representative of

national geology. EPA also relied on

data from the EPA/AWWARF study to

represent improperly constructed wells

because this study targeted wells

vulnerable to contamination and tested

wells monthly for a year. However, EPA

recognizes the variable nature of these

studies, as discussed in detail in section

II.C. Additionally, EPA had to rely on

CDC outbreak data to characterize the

causes of endemic ground water disease.

As discussed in section II. B., the U.S.

National Research Council suggests that

CDC numbers only represent a small

percentage of actual waterborne disease

outbreaks. The Agency also 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 ground

water systems or if other rules, such as

the TMDL, CAFO, and Class V UIC Well

Rules result in decreased fecal

contamination.

EPA did not have dose-response data

for all viruses and bacteria associated

with previous ground water disease

outbreaks. For viral illness, the Agency

used echo and rota viruses 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 low-to-medium

infectivity viruses that cause severe

illness and high infectivity viruses that

cause more mild illness. Further, there

is considerable uncertainty in the doseresponse functions used, even for these

two viruses. Dose-response 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. There is likely to be

variability in both of these parameters

across populations and based on case

specific circumstances, and only limited

data are available. Another uncertainty

30250 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

concerns the number of baseline

bacterial illness caused by ground water

contamination. The bacterial risk could

not be modeled because of lack of

occurrence and dose-response data.

Estimates of bacterial illness were made

based on a ratio of bacterial to viral

outbreak as documented by CDC and

applied to the viral risk estimate

discussed previously. There is also

considerable uncertainty in quantifying

the effectiveness of various regulatory

options in reducing risk. There is little

data currently on which to base

quantitative estimates of the

effectiveness of sanitary surveys or

routine monitoring in reducing

microbial risk, though there is some

qualitative research suggesting that

these can be effective strategies. To

model risk reduction quantitatively,

EPA relied primarily on best

professional judgment. The quantitative

estimates of risk reduction used in the

analysis are summarized in Table V–4a.

There is also uncertainty in the

valuation of risk reduction benefits. For

this analysis EPA used a 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. In general, however, COI

estimates understate benefits because

they do not account for the value people

place on reduced pain and suffering.

Some costs of today’s proposed rule

are also uncertain because of the diverse

nature of possible significant

deficiencies systems would need to

address. Also, the rule’s flexibility leads

to some uncertainty in estimates of who

will be affected by each rule component

and how States and systems will

respond to significant deficiencies.

These uncertainties could either under

or overestimate the costs of the rule.

EPA is in the process of proposing

regulations for radon and arsenic in

drinking water, which can impact some

ground water systems. EPA also intends

to finalize the Stage II Disinfection

Byproducts Rule by the statutory

deadline of May 2002. It is extremely

difficult to estimate the combined

effects of these future regulations on

ground water systems because of

various combinations of contaminants

that some systems may need to address.

However, it is possible for a system to

choose treatment technologies that

would deal with multiple problems.

Therefore, the total cost impact of these

drinking water rules is uncertain;

however, it may be less than the

estimated total cost of all individual

rules combined. Conversely, the impacts

on households and individual systems

of multiple rules is cumulative, and in

some cases maybe greater than the

impacts estimated in the RIA of each

rule separately.

I. Benefit Cost Determination

The Agency has determined that the

benefits of the proposed GWR justify the

costs. The mean quantified benefits

exceed the mean quantified costs by $22

million using a three percent discount

rate and $6 million using a seven

percent discount rate. EPA made this

determination based on provisions of

the multi-barrier option that include

improved sanitary surveys,

hydrogeologic sensitivity assessments

triggered and routine monitoring

provisions corrective actions, and

compliance monitoring. Overall, these

elements will reduce the risk of

microbial contamination reaching the

consumer. The quantified cost of these

provisions were compared to the

monetized benefits that result from the

reduction in viral and bacterial illness

and death. In addition, other nonmonetized benefits further justify the

costs of this rule.

J. Request for Comment

The Agency requests comment on all

aspects of the GWR RIA. Specifically,

EPA seeks input into the following two

issues.

1. NTNC and TNC Flow Estimates

In the GWR RIA, EPA estimates the

cost of the GWR on NTNC and TNC

water systems by using flow models.

However, these flow models were

developed to estimate flows only for

CWS and they may not accurately

represent the much smaller flows

generally found in NTNC and TNC

systems. The effect of the overestimate

in flow would be to inflate the cost of

the rule for these systems. The Agency

requests comment on an alternative flow

analysis for NTNC and TNC water

systems described next.

Instead of using the population served

data to determine the average flow for

use in the rule’s cost calculations, this

alternative approach would recategorize NTNC and TNC water

systems based on service type (e.g.,

restaurants or parks). Service type

would be obtained from SDWIS data.

However, service type data is not always

available because it is a voluntary

SDWIS data field. Where unavailable,

the service type would be assigned

based on statistical analysis. Estimates

of service type design flows would be

obtained from engineering design

manuals and best professional judgment

if no design manual specifications exist.

In addition, each service type category

would also have corresponding rates for

average population served and average

water consumption. These would be

used to determine contaminant

exposure which is used in the benefit

determination. Note that the current

approach of assuming that the entire

population served drinks an average of

1.2 liters per day for 250 days (from

NTNCWSs) and 15 days (from TNCWs)

may lead to an overestimation of

benefits. For example, schools and

churches would be two separate service

type categories. They each would have

their own corresponding average design

flow, average population served (rather

than the population as reported in

SDWIS), and average water

consumption rates. These elements

could be used to estimate a rule’s

benefits and costs for the average church

and the average school.

2. Mixed Systems

Current regulations require that all

systems that use any amount of surface

water as a source be categorized as

surface water systems. This

classification applies even if the

majority of water in a system is from a

ground water source. Therefore, SDWIS

does not provide the Agency with

information to identify how many

mixed systems exist. This information

would help the Agency to better

understand regulatory impacts. Further,

to the extent that mixed systems are

classified as surface water, the costs and

benefits of this proposed rule are

underestimated.

EPA is investigating ways to identify

how many mixed systems exist and how

many mix their ground and surface

water sources at the same entry point or

at separate entry points within the same

distribution systems. For example, a

system may have several plants/entry

points that feed the same distribution

system. One of these entry points may

mix and treat surface water with ground

water prior to its entry into the

distribution system. Another entry point

might use ground water exclusively for

its source while a different entry point

would exclusively use surface water.

However, all three entry points would

supply the same system classified in

SDWIS as surface water.

One method EPA could use to address

this issue would be to analyze CWSS

data then extrapolate this information to

SDWIS to obtain a national estimate of

mixed systems. CWSS data, from

approximately 1,900 systems, details

sources of supply at the level of the

entry point to the distribution system

and further subdivides flow by source

type. The Agency is considering this

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30251

national estimate of mixed systems to

regroup surface water systems for

certain impact analyses when

regulations only impact one type of

source. For example, surface water

systems that get more than 50 percent of

their flow from ground water would be

counted as a ground water system in the

regulatory impact analysis for this rule.

The Agency requests comment on this

methodology and its applicability for

use in regulatory impact analysis.

VI. Other Requirements

A. Regulatory Flexibility Act (RFA), as

Amended by the Small Business

Regulatory Enforcement Fairness Act of

1996 (SBREFA), 5 U.S.C. 601 et seq.

1. Background

The 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.

2. Use of Alternative Definition

The RFA provides default definitions

for each type of small entity. It 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. secs. 601(3)—(5)). In addition,

agencies must consult with SBA’s Chief

Counsel for Advocacy to establish an

alternative small business definition.

EPA is proposing the GWR which

contains provisions which apply to

small PWSs serving fewer than 10,000

persons. This is the cut-off level

specified by Congress in the 1996

Amendments to the Safe Drinking Water

Act for small system flexibility

provisions. Because this definition does

not correspond to the definitions of

‘‘small’’ for small businesses,

governments, and non-profit

organizations, EPA requested comment

on an alternative definition of ‘‘small

entity’’ in the preamble to the proposed

Consumer Confidence Report (CCR)

regulation (63 FR 7620, February 13,

1998). Comments showed that

stakeholders support the proposed

alternative definition. EPA also

consulted with the SBA Office of

Advocacy on the definition as it relates

to small business analysis. In the

preamble to the final CCR regulation (63

FR 4511, August 19, 1998). EPA stated

its intent to establish this alternative

definition for regulatory flexibility

assessments under the RFA for all

drinking water regulations and has thus

used it in this proposed rulemaking.

The SBA Office of Advocacy agrees with

the use of this definition in this

rulemaking.

3. Initial Regulatory Flexibility Analysis

In accordance with section 603 of the

RFA, EPA prepared an initial regulatory

flexibility analysis (IRFA) that examined

the impact of the proposed rule on small

entities along with regulatory

alternatives that could reduce that

impact. The IRFA addresses the

following issues:

• The reasons the Agency is

considering this action;

• The objectives of, and legal basis for

the proposed rule;

• The number and types of small

entities to which the rule will apply;

• Projected reporting, recordkeeping,

and other compliance requirements of

the proposed rule, including the classes

of small entities which will be subject

to the requirements and the type of

professional skills necessary for

preparation of the reports and records;

• The other relevant Federal rules

which may duplicate, overlap, or

conflict with the proposed rule; and,

• Any significant alternatives to the

components under consideration which

accomplish the stated objectives of

applicable statutes and which may

minimize any significant economic

impact of the proposed rule on small

entities.

a. The Reasons the Agency Is

Considering This Action

EPA believes that there is a

substantial likelihood that fecal

contamination of ground water supplies

is occurring at frequencies and levels

which 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 which consume them.

Fecal contamination is introduced to

ground water from a number of sources

including, septic systems, leaking sewer

pipes, landfills, sewage lagoons,

cesspools, and storm water runoff.

Microorganisms can be transported with

the ground water as it moves through an

aquifer. In addition, the transport of

microorganisms to wells or other ground

water system sources can also be

affected by poor well construction (e.g.,

improper well seals) which can result in

large, open conduits for fecal

contamination to pass unimpeded into

the water supply.

Waterborne pathogens contained in

fecally contaminated water can result in

a variety of illnesses which range in the

severity of their outcomes from mild

diarrhea to kidney failure or heart

disease. The populations which are

particularly sensitive to waterborne and

other pathogens include, infants, young

children, pregnant and lactating women,

the elderly and the chronically ill.

These individuals may be more likely to

become ill as a result of exposure to the

pathogens, and are likely to have a more

severe illness. A complete discussion of

the public health concerns addressed by

the GWR can be found in section II of

the preamble.

b. The Objectives of, and the Legal Basis

for, the Proposed Rule

EPA is proposing the GWR pursuant

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

amended in 1996, 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 1996 amendments establish a

statutory deadline of May 2002. EPA,

however, intends to finalize the GWR in

the year 2000 to coincide with

implementation of other drinking water

regulations and programs, such as the

Disinfection Byproducts Rule, the

Arsenic Rule, the Radon Rule and the

Source Water Assessment and

Protection Program (SWAPP). EPA

believes systems and States will better

plan for changes in operation and

capital improvements if they presented

them with future regulatory

requirements at one time.

c. Number of Small Entities Affected

According to the December 1997 data

from EPA’s Safe Drinking Water

Information System (SDWIS), there are

156,846 community water systems and

non-community water supplies

providing potable ground water to the

public, of which 155,254 (99 percent)

are classified by EPA as small entities.

EPA estimates that these small ground

water systems serve a population of

more than 48 million. Roughly onequarter of these systems are estimated to

be community water systems serving

fixed populations on a year-round basis.

Under the proposed option, all

community and non-community water

systems are affected by at least one

requirement; the sanitary survey

provision. The other GWR components

are estimated to affect different numbers

30252 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

of small systems. For example, over

4,300 small systems are expected to

have to fix significant deficiencies each

year.

d. Small Entity Impacts

Reporting and Recordkeeping for the

Proposed GWR

Under the proposed Multi-Barrier

option, there are a number of

recordkeeping and reporting

requirements for all ground water

system (including small systems). To

minimize the burden with these

provisions, the EPA is proposing a

targeted risk-based regulatory strategy

whereby the monitoring requirements

are based on system characteristics and

not directly related to system size. In

this manner, the multi-barrier option

takes a system-specific approach to

regulation, although a sanitary survey is

required of all community and nontransient non-community water

systems. However, the implementation

schedule for this requirement is

staggered (e.g., every three to five years

for CWSs and every five years for

NCWSs), which should provide some

relief for small systems because there

are proportionately more NCWSs.

To address concerns over the

potential cost of additional monitoring

for small systems, the proposed GWR

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). In this

proposal, only systems that do not

reliably treat to 4-log inactivation or

removal of viruses are required to test

for the presence of E. coli, coliphage, or

enterococci in the source water within

24 hours of a total coliform positive

sample in the distribution system.

Only systems determined to be

hydrogeologically sensitive and do not

already treat to 4-log inactivation or

removal of viruses are required to

conduct the additional routine

monitoring. If no fecal indicators are

found after 12 months of monitoring,

the State may reduce the monitoring

frequency for that system. Similarly, if

a non-sensitive system does not have a

distribution system, any sample taken

for TCR compliance is effectively a

source water sample, so an additional

triggered source water sample would

not be required. In both cases, however,

if the system has a positive sample for

E. coli, coliphage, or fecal coliform, the

system is required to conduct the

necessary follow-up actions.

Small Entity Compliance Costs for the

Proposed GWR

Estimates of the cost of complying

with each component of the multibarrier approach are presented next. The

estimated impacts for this proposed

option are based on the national mean

compliance cost across the four

compliance scenarios. System-level

impacts are investigated using various

corrective action and significant defects

scenarios. The high correction action/

low significant defect scenario is

considered a typical cost estimate. For

more information on these scenarios

and cost assumptions, consult the

Regulatory Impact Analysis for the

Proposed Ground Water Rule (USEPA,

1999a) which is available for review in

the water docket.

In determining the costs and benefits

of this proposed rule, EPA considered

the full range of both potential costs and

benefits for the rule. The flexibility of

the risk-based targeted approach of the

rule aims to reduce the cost of

compliance with the rule. Small systems

will benefit from the flexibility provided

in this design. For example, a small

system with fecal contamination will, in

consultation with the State, be able to

select the least costly corrective action.

Also, small systems serving less than

3,300 people which disinfect will only

be required to monitor their treatment

effectiveness one time per day as

opposed to the continuous monitoring

required for larger systems which

disinfect. Estimates of annual CWS

compliance costs for the multi-barrier

approach are presented in Table VI–1.

TABLE VI–1.—ANNUAL COMPLIANCE COSTS FOR THE PROPOSED GWR BY CWS SYSTEM SIZE AND TYPE

CWS system type

System size/population served

<100 101–500 501–1,000 1,001–3,300 3,301–10K

Publicly-Owned .................................................................... $825 $934 $1,238$ $1,950 $4,480

Privately-Owned ................................................................... 799 933 1,449 1,730 5,358

All Systems .......................................................................... 805 933 1,328 1,893 4,652

e. Coordination With Other Federal

Rules

To avoid duplication of effort, the

proposed GWR encourages States to use

their source water assessments when the

assessment provides data relevant to the

sensitivity assessment of a system.

Although not a regulatory program,

source water assessments are currently

being performed by States. The schedule

for the sensitivity assessment (within

six years for CWS and eight years for

NCWS) should allow States to complete

the assessment and the first round of

sanitary surveys concurrently if they

choose to do so.

EPA has structured this GWR

proposal as a targeted, risk-based

approach to reducing fecal

contamination. The only regulatory

requirement that applies to all ground

water systems is the sanitary survey.

The Agency has also considered other

drinking water contaminants that may

be of concern when a system install

disinfection. Specifically, adding

disinfection may result in an increase in

other contaminants of concern,

depending on the characteristics of the

source water and the distribution

system. These contaminants include

disinfection byproducts, lead, copper,

and arsenic. EPA believes that these

issues, when they occur will be very

localized and may be addressed through

selection of the appropriate corrective

action. EPA has provided States and

systems with the flexibility to select

among a variety of corrective actions.

These include options such as UV

disinfection, or purchasing water from

another source, which would avoid

these types of problems.

f. Minimization of Economic Burden

Description of Regulatory Options

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 across-the-board

disinfection option. These options are

described in more detail in section III of

this preamble.

On an annual basis, the cost of the

proposed alternative ranges from $182.7

million to $198.6 million, using a three

and seven percent discount rate. System

costs make up 89 percent of the total

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30253

rule costs. In developing this proposal,

however, EPA considered the

recommendations to minimize the cost

impact to small systems. The proposed

multi-barrier, risk-based approach was

designed to achieve maximum public

health protection while avoiding

excessive compliance costs associated

with Across-the-Board Disinfection

regulatory compliance requirements.

To mitigate the associated compliance

cost increases across water systems, the

proposed GWR also provides States

with considerable flexibility when

implementing the rule. This flexibility

will allow States to work within their

existing program. Similarly, the rule

allows States to consider the

characteristics of individual systems

when determining an appropriate

corrective action. For example, States

have the flexibility to allow systems to

obtain a new source, or use any

disinfection treatment technology,

provided it achieves 4-log inactivation

or removal of pathogens.

4. Small Entity Outreach and Small

Business Advocacy Review Panel

As required by section 609(b) of the

RFA, as amended by SBREFA, EPA also

conducted outreach to small entities

and convened a Small Business

Advocacy Review Panel to obtain advice

and recommendations of representatives

of the small entities that potentially

would be subject to the rule’s

requirements. The SBAR Panel members

for the GWR were the Small Business

Advocacy Chair of the Environmental

Protection Agency, the Director of the

Standards and Risk Management

Division in the Office of Ground Water

and Drinking Water (OGWDW) within

EPA’s Office of Water, the

Administrator for the Office of

Information and Regulatory Affairs of

the Office of Management and Budget

(OMB), and the Chief Counsel for

Advocacy of the Small Business

Administration (SBA). The Panel

convened on April 10, 1998, and met

seven times before the end of the 60-day

Panel period on June 8, 1998. The SBAR

Panel’s report Final Report of the

SBREFA Small Business Advocacy

Review Panel on EPA’s Planned

Proposed Rule for National Primary

Drinking Water Regulations: Ground

Water, the small entity representatives

(SERs) comments on components of the

GWR, and the background information

provided to the SBAR Panel and the

SERs are available for review in the

Office of Water docket. This information

and the Panel’s recommendations are

summarized in section VI.A.4.a.

Prior to convening the SBAR Panel,

EPA consulted with a group of 22 SERs

likely to be impacted by a GWR. The

SERs included small system operators,

local government officials (including

elected officials), small business owners

(e.g., a bed and breakfast with its own

water supply), and small nonprofit

organizations (e.g., a church with its

own water supply for the congregation).

The SERs were provided with

background information on the GWR, on

the need for the rule and the potential

requirements. The SERs were asked to

provide input on the potential impacts

of the rule from their perspective. All 22

SERs commented on the information

provided. These comments were

provided to the SBAR Panel when the

Panel convened. After a teleconference

between the SERs and the Panel, the

SERs were invited to provide additional

comments on the information provided.

Three SERs provided additional

comments on the rule components after

the teleconference. In general, the SERs

consulted on the GWR were concerned

about the impact of the rule on small

water systems (because of their small

staff and limited budgets), the

additional monitoring that might be

required, and the data and resources

necessary to conduct a hydrogeologic

sensitivity assessment or sanitary

survey. There was also considerable

discussion about how nationally

representative the source data was. SER

suggested providing flexibility to the

States implementing these provisions

and opposed mandatory disinfection

across-the-board. SERs expressed

support for existing monitoring

requirements as a means of determining

compliance, and some supported

increased requirements for total

coliform monitoring.

Consistent with the RFA/SBREFA

requirements, the Panel evaluated the

assembled materials and small-entity

comments related to the elements of the

IRFA. A copy of the Panel report is in

the Office of Water docket for this

proposed rule.

a. Number of Small Entities to Which

the Rule Will Apply

When the IRFA was prepared, EPA

estimated that there were over 157,000

small ground water systems that could

be affected by the GWR, serving a

population of more than 48 million.

Roughly one-third of these systems are

community water systems (CWS). The

remainder are non-community water

systems (NCWS) (i.e. non-transient noncommunity such as schools and

transient non-community such as

restaurants). A more detailed and

current discussion of the impact of the

proposed rule on small entities can be

found in section V of this preamble.

The SBAR Panel recommended that,

given the number of systems that could

be affected by the rule, EPA should

consider focusing compliance

requirements on those systems most at

risk of fecal contamination. The GWR

addresses this issue and is designed to

target the systems at highest risk. Risk

characterization is based on system

characteristics, i.e., significant

deficiencies in operation or

maintenance and hydrogeologic

sensitivity to contamination. A system

is not required to perform an action

such as source water microbial

monitoring until the State has cause to

believe the system is at risk.

The Panel also recommended that the

rule requirements be based on system

size. Because the GWR is a targeted riskbased rule, the regulatory strategy is

based on system-specific risk indicators

that are not directly related to system

size. However, the monitoring required

for treatment effectiveness (compliance

monitoring) varies based on system size.

Ninety-seven percent of all ground

water systems serve less than 3,300

people. Under the proposed GWR,

disinfecting ground water systems

serving less than 3,300 people must

monitor treatment by taking daily grab

samples. Disinfecting ground water

systems serving 3,300 or more people

must monitor treatment continuously.

The SBAR Panel advocated that States

be provided with flexibility when

implementing the rule. The GWR also

addresses this issue. As discussed

earlier in sections III.A.1. and 2. of this

proposal, States have considerable

flexibility in addressing potential

problems in small systems. In

particular, States have the flexibility to

define and identify significant system

deficiencies and to describe their

approaches to identifying the presence

of hydrogeologic barriers to

contamination. States also have the

flexibility to require correction of fecal

contamination or use any disinfection

treatment technology, provided it

achieves 4-log (99.99%) inactivation or

removal of viruses. Similarly, the rule

allows States to consider the

characteristics of individual systems

when determining an appropriate

corrective action.

b. Record Keeping and Reporting and

Other Compliance Requirements

Because small systems frequently

have minimal staff and resources,

including data on the underlying

hydrogeology of the system, the SBAR

Panel recommended that EPA focus the

record keeping, reporting, and

compliance requirements on those

systems at greatest risk of fecal

30254 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

contamination. The Panel also

recommended that EPA consider

tailoring the requirements based on

system size (e.g., the smaller systems

would not have to monitor as frequently

or perform sanitary surveys on the same

schedule.)

The GWR proposed today is a targeted

risk-based regulatory strategy. The

regulatory strategy is based on system

characteristics (i.e., hydrogeologic

sensitivity; TCR positive in the

distribution system) and is not directly

related to system size. However, the

monitoring required for treatment

effectiveness (compliance monitoring)

varies based on system size. Ninetyseven percent of all ground water

systems serve less than 3,300 people.

Under the proposed GWR, disinfecting

ground water systems serving less than

3,300 people must monitor treatment by

taking daily grab samples. Disinfecting

ground water systems serving 3,300 or

more people must monitor treatment

continuously. In addition, the only

across-the-board requirement is for

sanitary surveys, but the

implementation schedule is staggered

(e.g., every 3 years for CWS and every

5 years for NCWS) which should

provide some relief for small systems

because there are proportionately more

that are NCWS. EPA is also requesting

comment on several options that would

reduce the required frequency of

sanitary surveys. Because many small

systems may not have easy access to the

records that would ideally be available

for a hydrogeologic sensitivity

assessment or a sanitary survey, EPA,

after consulting with stakeholders and

the SBAR Panel, has determined that it

will not use the lack of adequate well

records, the lack of a cross connection

program, or intermittent pressure

fluctuations as automatic triggers to

indicate risk of potential contamination.

These factors may be considered along

with others that more definitively

demonstrate risk. This strategy will

enable States to focus their resources on

the systems which need the most

surveillance or follow-up action and

will avoid penalizing systems with

limited resources.

With respect to the potential cost of

additional monitoring for small systems,

particularly if the rule required viral

monitoring, the SBAR Panel offered

several recommendations. First, the

Panel suggested that, to the extent

possible, the GWR should build on the

existing monitoring framework in the

TCR. Given the low cost of the Total

Coliform test, the Panel noted that an

increase in the frequency and the

locations for TCR monitoring or

additional samples in the source water

if the system has a Total Coliform

positive sample would be preferable to

other fecal indicator tests, given the

current cost of a viral test. However, the

Panel also recommended that the EPA

continue to develop a lower cost, more

accurate test to identify viral and

bacterial contamination in drinking

water.

Today’s proposal does build on the

existing TCR monitoring framework by

using the results of the TCR monitoring

to determine if source water monitoring

is required. In the proposal, a system is

required to test for the presence of E.

coli, coliphage, or enterococci in the

source water within 24 hours of a total

coliform positive sample in the

distribution system. Only systems

determined to be hydrogeologically

sensitive that do not already treat their

water to 4-log inactivation or removal

are required to conduct the additional

routine monitoring. These systems must

test their source water monthly. If no

fecal indicators are found after 12

consecutive months of monitoring, the

State may reduce the monitoring

frequency for that system. Similarly, if

a non-sensitive system does not have a

distribution system, any sample taken

for TCR compliance is effectively a

source water sample so an additional

triggered source water sample would

not be required. In both cases, however,

if the system has an E. coli, coliphage,

or fecal coliform positive sample, the

system is required to conduct the

necessary follow-up actions.

The GWR also has incorporated lowcost fecal contamination indicator tests.

EPA-approved methods for detecting

bacterial indicators of fecal

contamination, including E. coli and

enterococci, are already widely used

and are low cost (approximately $25 per

sample). In addition, EPA is currently

developing viral monitoring methods

which will cost approximately the same

as existing bacterial methods.

The SBAR Panel recommended that

States be provided with flexibility when

implementing the rule. For example,

while States must have the authority to

require the correction of significant

deficiencies, States should also have the

flexibility to determine which

deficiencies are ‘‘significant’’ from a

public health perspective. When a State

determines that corrective action is

necessary, it should have the flexibility

to determine what actions a system

should take, including but not limited to

disinfection. Similarly, States should

also have the flexibility to require

disinfection across-the-board for all or a

subset of the public water supply

systems in their State. States should also

be given the flexibility to choose from

the full range of disinfection

technologies that will meet the public

health goals of the rule.

As discussed earlier in sections

III.A.1. and 2. of this proposal, States

have considerable flexibility in

addressing potential problems in small

systems particularly with respect to

sanitary survey, where States define and

identify significant deficiencies, and in

conducting hydrogeologic sensitivity

assessments. The GWR allows States

flexibility to work within their existing

programs and define and identify

significant deficiencies. States also have

the flexibility to require correction of

fecal contamination or use any

disinfection treatment technology,

provided it achieves 4-log (99.99%)

inactivation or removal of viruses.

Similarly, the rule allows States to

consider the characteristics of

individual systems when determining

an appropriate corrective action.

The Panel was also concerned about

the potential cost of disinfection and

recommended that EPA include a full

range of variables when determining

both the potential cost burden and

benefits of the rule.

In determining the costs and benefits

of today’s proposed rule, EPA

considered the full range of both

potential costs and benefits for the rule.

The flexibility in the rule is designed to

reduce the cost of compliance with the

rule, particularly for small systems.

While determining the costs of the

various technologies, EPA has estimated

the percentage of systems in

consultation with the States that will

choose between the different

technologies, in part based on system

size. When determining the benefits of

today’s proposal, EPA considered a

range of benefits from reduction in

illness and mortality to outbreak cost

avoided and possibly reduced

uncertainty and averting behaviors.

However, only reductions in acute viral

and bacterial illness and decreases in

mortality from virus are monetized.

More detailed cost and benefit

information is included in the GWR RIA

(US EPA, 1999a) for today’s proposal.

Because systems are highly variable, the

SBAR Panel recommended that States

be given the flexibility to determine

appropriate maintenance or cross

connection control measures for each

system and to the extent practicable

maintenance measures should be

performance-based.

EPA recognizes that systems’

characteristics are highly variable.

States have considerable flexibility

when working with systems to address

significant deficiencies, conduct

hydrogeological sensitivity assessments,

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30255

and take corrective action. Cross

connection control will be considered

under a future rulemaking (i.e., the Long

Term 2 Enhanced Surface Water

Treatment Rule).

c. Other Federal Rules

To avoid duplication of effort, the

SBAR Panel recommended using the

State Source Water Assessment and

Protection Program (SWAPP) plans and

susceptibility assessments as a

component of the hydrogeologic

sensitivity assessment process. To

further streamline the process,

especially for small systems, the Panel

also recommended combining the

hydrogeologic sensitivity assessment

with the sanitary surveys.

In today’s GWR proposal, States are

encouraged to use their SWAPP

assessments when the assessment

provides data relevant to the

hydrogeologic sensitivity assessment of

a system. The schedule for sensitivity

assessments (six years after the GWR is

promulgated in the Federal Register for

CWS and eight years after the GWR is

promulgated in the Federal Register for

NCWS) should allow States to complete

the assessment and the first round of

sanitary surveys concurrently if they

choose to do so.

d. Significant Alternatives

Because the SBREFA consultation

was conducted early in the regulatory

development process before there was a

draft proposal, few comments were

received on specific regulatory

alternatives. In general, the SERs

supported the approach described in the

outreach materials while at the same

time commenting on particular aspects

of the approach that might be

burdensome or otherwise problematic.

Their concerns echo the comments

received on other parts of the IRFA.

The SBAR Panel reiterated their

suggestion that compliance

requirements be tailored to the system

size. In particular, if the minimum

monitoring frequency and the frequency

for sanitary surveys for the smallest

systems (e.g., those serving less than 500

people) could be reduced, it would

reduce both the resources necessary to

comply with the rule and record

keeping required by the system.

EPA has structured today’s proposal

as a targeted risk-based approach to

reducing fecal contamination. The only

requirement that affects all GWSs is the

sanitary survey. The required frequency

for sanitary surveys for community

systems is once every three years which

may be changed by the State to once

every five years if the system either

treats to 4-log inactivation or removal of

virus or has an outstanding performance

record documented in previous

inspections and has no history of total

coliform MCL or monitoring violations

since the last sanitary survey under

current ownership. The required

frequency for sanitary surveys is once

every five years for noncommunity

systems. The majority of the small

systems are noncommunity systems so

the majority of systems will only have

a sanitary survey once every five years.

At this frequency, EPA believes that the

requirements will not be burdensome

for even the smallest systems, however

EPA is also requesting comment on less

frequent sanitary survey requirements.

Similarly, the only additional

monitoring requirements in today’s

proposal are for undisinfected systems

that are either located in sensitive

hydrogeologic settings or have a total

coliform positive sample in the

distribution system. The monitoring

required for a total coliform positive

sample under the TCR would be a onetime event while the monitoring for

sensitive systems would be on a routine

monthly basis for at least 12 samples.

Finally, the SBAR Panel noted that

disinfection of public water supplies

may result in an increase in other

contaminants of concern, depending on

the characteristics of the source water

and the distribution system. Of

particular concern were disinfection

byproducts, lead, copper, and arsenic.

EPA has discussed these issues

previously in section V.G. of the GWR

preamble. EPA believes that these

issues, when they occur, will typically

be localized and transitory. These risk/

risk tradeoffs are considered

qualitatively in the RIA and EPA will

provide guidance on how to address

these issues when the rule is finalized.

e. Other Comments

The panel members could not reach

consensus regarding the use of

occurrence data to support the rule.

Some panel members expressed the

concern that the occurrence estimates

discussed by EPA with the SERs

overestimated the actual occurrence of

fecal contamination and the studies

used did not provide a true picture of

national occurrence. EPA recognizes

and understands the concerns about the

available data expressed by these panel

members. However, the Agency

believes, after consulting with experts in

the field, that the available data may

underestimate the extent of ground

water contamination because of

limitations with sampling methods and

frequency. EPA believes that a central

issue for all participants and

stakeholders in this rulemaking is how

to interpret the available data. EPA

agrees that the GWR must be based on

the best available data, good science and

sound analysis. The studies described in

the materials presented to the SERs and

SBAR Panel during the SBREFA process

were conducted at different times and

for different reasons; each requires

careful analysis to ensure its proper use

and to avoid misuse. A more detailed

discussion of the occurrence studies and

request for comment on their

interpretation is provided in section

II.C. of today’s proposal.

EPA invites comments on all aspects

of the proposal and its impacts on small

entities.

B. Paperwork Reduction Act

The information collection

requirements in this proposed rule have

been submitted for approval to the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq. An

Information Collection Request (ICR)

document has been prepared by EPA

(ICR No. 1934.01) and a copy may be

obtained from Sandy Farmer by mail at

Collection Strategies Division; U.S.

Environmental Protection Agency

(2822); 1200 Pennsylvania Ave., NW,

Washington, DC 20460, by email at

farmer.sandy@epamail.epa.gov, or by

calling (202) 260–2740. A copy may also

be downloaded from the Internet at

http://www.epa.gov/icr. For technical

information about the collection contact

Jini Mohanty by calling (202) 260–6415.

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

in Part 141, for systems, and Part 142,

for States are mandatory. The

information collected is not

confidential.

EPA estimates that the annual burden

on PWSs and States for reporting and

record keeping will be 326,215 hours.

This is based on an estimate that 56

States and territories will each need to

provide 3 responses each year with an

average of 524 hours per response, and

that 52,331 systems will each provide

2.3 responses each year with an average

of less than 2 hours per response. The

labor burden is estimated for the

following activities: Reading and

understanding the rule, planning,

training, and meeting primacy

requirements. The recordkeeping and

reporting burden also includes capital

costs of $1,376,302 for capital

30256 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

improvements by PWSs (installation of

disinfection monitoring equipment).

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 are listed

in 40 CFR Part 9 and 48 CFR Chapter

15.

Comments are requested on the

Agency’s need for this information, the

accuracy of the provided burden

estimates, and any suggested methods

for minimizing respondent burden,

including the use of automated

collection techniques. Send comments

on the ICR to the Director, Collection

Strategies Division; U.S. Environmental

Protection Agency (2822); 1200

Pennsylvania Ave, N.W.; Washington,

DC 20460; and to the Office of

Information and Regulatory Affairs,

Office of Management and Budget, 725

17th St., N.W., Washington, DC 20503,

marked ‘‘Attention: Desk Officer for

EPA.’’ Include the ICR number in any

correspondence. Since OMB is required

to make a decision concerning the ICR

between 30 and 60 days after May 10,

2000, a comment to OMB is best assured

of having its full effect if OMB receives

it by June 9, 2000. The final rule will

respond to any OMB or public

comments on the information collection

requirements contained in this proposal.

C. Unfunded Mandates Reform Act

1. Summary of UMRA Requirements

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA), Public

Law 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 UMRA section 202, EPA

generally must prepare a written

statement, including a cost-benefit

analysis, for proposed and final rules

with ‘‘Federal mandates’’ that may

result in State, local and tribal

government expenditures, in the

aggregate, or private sector

expenditures, 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

notification to 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.

2. Written Statement for Rules With

Federal Mandates of $100 Million or

More

EPA has determined that this rule

contains a Federal mandate that may

result in expenditures of $100 million or

more for the private sector in any one

year.

Table VI–2 presents a breakdown of

the estimated $182.7 to$198.6 million

annual cost for today’s proposed rule

(the proposed Multi-Barrier Option).

Public ground water systems owned by

State, local and tribal governments will

incur $51.2 to $56.5 million of these

costs and States will incur an additional

$20.1 to $22.1 million for a total public

sector cost of $71.3 to $78.7 million

dollars per year. Public ground water

systems which are owned by private

entities will incur a total cost of $111.5

to $ 119.9 million per year, $5.5 to $7

million of which is incurred by entities

that operate a public water system as a

means of supporting their primary

business (e.g., a mobile home park

operator).

TABLE VI–2.—PUBLIC AND PRIVATE

COSTS FOR OF THE PROPOSED GWR

System type

Annual mean

cost range*

(millions $)

Percent of

total

cost

Public PWS Cost $51.2 to $56.5 28

State Cost ............ 20.1 to 22.1 .... 11

Total Public Cost 71.3 to 78.7 .... 40

Private PWS Cost 106.0 to 113.0 57

Ancillary PWS

Cost.

5.5 to 7.0 ........ 4

Total Private

Cost.

111.5 to 119.9 60

Total Cost ..... 182.7 to 198.6 100

Note: Cost range based upon a 3% and 7%

discount rate.

Thus, today’s rule is subject to the

requirements of sections 202 and 205 of

the UMRA, and EPA has prepared a

written statement which is summarized

next. A more detailed description of this

analysis is presented in EPA’s

Regulatory Impact Analysis of the GWR

(US EPA, 1999a) which is included in

the Office of Water docket for this rule.

a. Authorizing Legislation

Today’s proposed rule is promulgated

pursuant to section 1412(b)(8) of the

SDWA, as amended in 1996, 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.’’

Section 1412 (b)(8) also establishes a

statutory deadline for promulgation of

the GWR of no later than the date on

which the Administrator promulgates a

Stage II rulemaking for disinfectants and

disinfection byproducts. EPA intends to

finalize the GWR in the year 2000 to

allow systems to consider the combined

impact of this rule, the radon rule, the

arsenic rule and the Stage 1 DBP rule on

their design and treatment modification

as well as their capital investment

decisions. EPA believes States and

systems will better plan for changes in

operation and capital improvements, if

they are presented with future

requirements at one time.

b. Cost Benefit Analysis

Section V of this preamble discusses

the cost and benefits associated with the

GWR . Also, EPA’s Regulatory Impact

Analysis of the GWR (US EPA, 1999a)

contains a detailed cost benefit analysis.

The analysis quantifies cost and benefits

for four scenarios: the proposed

regulatory option, the sanitary survey

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30257

option, the sanitary survey and triggered

monitoring option, and the across-theboard disinfection option. Table VI–3

summarizes the range of annual costs

and benefits for each rule option.

TABLE VI–3.—ANNUAL BENEFITS AND COSTS OF RULE OPTIONS ($MILLION)

Option

Annual benefits 1

mean

[range]

$million

Annual costs

(3%)

mean

[range]

$million

Annual costs 2

(7%)

mean

[range]

$million

Sanitary Survey ................................................................................................... $33

[$9 to $58]

$73

[$71 to $74]

$76

[$74 to $78]

Sanitary Survey and Triggered Monitoring .......................................................... $178

[$147 to $209]

$158

[$152 to $19]

$169

[$163 to $174]

Multi-barrier (Proposed ) Option .......................................................................... $205

[$169 to $242]

$183

[$177 to $188]

$199

[$192 to $206]

Across-the-Board Disinfection ............................................................................. $283

[$255 to $311]

$777

[$744 to $810]

$866

[$823 to $909]

1 does not include benefits from reduction in chronic illness, reduced pain and suffering, or non-health benefits.

2 does not include non-quantified costs such as land acquisition or increases in other contaminants (e.g., DBPs).

Costs varied with each option and

were driven by the number of systems

that would need to fix a significant

deficiency, take corrective action in

response to fecal contamination, or

install treatment. The annual mean cost

of the four rule options ranges from $73

million to $866 million using a three

percent and seven percent discount rate.

For the first three options, the costs

increase as more components are added

for identifying fecally contaminated

wells and wells sensitive to fecal

contamination. However, the cost of

these components (e.g., hydrogeologic

sensitivity assessment, routine and

triggered monitoring) are minor

compared to the costs of correcting fecal

contamination. The fourth option of

across-the-board disinfection is the most

costly because it would require all

systems to have treatment regardless of

actual or potential fecal contamination.

Costs for the States to implement this

rule are also included in the four cost

estimates. Some costs, such as land

acquisition where necessary to install

treatment, were not included because of

the difficulty of estimating them.

These total annual monetized costs

can be compared to the annual

monetized benefits of the GWR. The

annual monetized mean benefits of

today’s rule range from $33 million to

$283 million as shown in Table VI–2.

This result is based on the

quantification of the number of acute

viral illnesses and deaths avoided

attributable to each option as well as the

reduction in acute bacterial illness

attributable to each option. For illness,

EPA used a cost-of-illness number to

estimate the benefits from the reduction

in viral illness that result from this rule.

This is considered a lower-bound

estimate of actual benefits because it

does not include the pain and

discomfort associated with the illness.

Mortalities were valued using a value of

statistical life estimate consistent with

EPA policy.

This rule will also decrease bacterial

illness associated with fecal

contamination of ground water. EPA did

not directly calculate the actual

numbers of illness associated with

bacterially contaminated ground water

because the Agency lacked the

necessary pathogen occurrence data to

include it in the risk model. However,

in order to get an estimate of the number

of bacterial illness from fecally

contaminated ground water, the Agency

used the ratio of viral and unknown

etiology outbreak illness to bacterial

outbreak illnesses reported to CDC’s for

waterborne outbreaks in ground water.

It was further assumed that the cost of

these bacterial illnesses would be

comparable to viral illness estimates.

This rule also considered but did not

monetize the health benefit from the

reduction in chronic illness associated

with some viral and bacterial infections

(see section II.D.).

Various Federal programs exist to

provide financial assistance to State,

local, and tribal governments in

complying with this rule. The Federal

government provides funding to States

that have primary enforcement

responsibility for their drinking water

programs through the Public Water

Systems Supervision Grants Program.

Additional funding is available from

other programs administered either by

EPA or other Federal agencies. These

include EPA’s Drinking Water State

Revolving Fund (DWSRF), U.S.

Department of Agriculture’s Rural

Utilities’ Loan and Grant Program, and

Housing and Urban Development’s

Community Development Block Grant

Program.

For example, SDWA authorizes the

Administrator of the EPA to award

capitalization grants to States, which in

turn can provide low cost loans and

other types of assistance to eligible

public water systems. The DWSRF

assists public water systems with

financing the costs of infrastructure

needed to achieve or maintain

compliance with SDWA requirements.

Each State has considerable flexibility

in determining the design of its DWSRF

Program and to direct funding toward

its most pressing compliance and public

health protection needs. States may

also, on a matching basis, use up to 10

percent of their DWSRF allotments for

each fiscal year to assist in running the

State drinking water program. In

addition, States have the flexibility to

transfer a portion of funds to the

Drinking Water State Revolving Fund

from the Clean Water State Revolving

Fund.

Furthermore, a State can use the

financial resources of the DWSRF to

assist small systems, the majority of

which are ground water systems. In fact,

a minimum of 15% of a State’s DWSRF

grant must be used to provide

infrastructure loans to small systems.

Two percent of the State’s grant may be

used to provide technical assistance to

small systems. For small systems that

are disadvantaged, up to 30% of a

State’s DWSRF may be used for

increased loan subsidies. Under the

DWSRF, Tribes have a separate set-aside

which they can use.

In addition to the DWSRF, money is

available from the Department of

Agriculture’s Rural Utility Service

(RUS) and Housing and Urban

Development’s Community

30258 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

Development Block Grant (CDBG)

program. RUS provides loans,

guaranteed loans, and grants to improve,

repair, or construct water supply and

distribution systems in rural areas and

towns up to 10,000 people. In Fiscal

Year 1997, the RUS had over $1.3

billion in available funds. Also, three

sources of funding exist under the

CDBG program to finance building and

improvements of public facilities such

as water systems. The three sources of

funding include: (1) direct grants to

communities with populations over

200,000; (2) direct grants to States,

which they in turn award to smaller

communities, rural areas, and colonias

in Arizona, California, New Mexico, and

Texas; and (3) direct grants to US.

Territories and Trusts. The CDBG

budget for Fiscal Year 1997 totaled over

$4 billion dollars.

c. Estimates of Future Compliance Costs

and Disproportionate Budgetary Effects

To meet the UMRA requirement in

section 202, EPA analyzed future

compliance costs and possible

disproportionate budgetary effects. The

Agency believes that the cost estimates,

indicated earlier and discussed in more

detail in section V of this rule,

accurately characterize future

compliance costs of the proposed rule.

In analyzing disproportionate

impacts, the Agency considered three

measures: reviewing the impacts on

small systems versus large systems;

reviewing the costs to public versus

private water systems; and reviewing

the household costs for each proposed

rule option. It is also possible that some

States or EPA Regions may face greater

challenges from the GWR because they

have comparatively more ground water

systems. However, States that have a

larger percentage of systems also receive

a greater share of the Public Water

Systems Supervision Grants Program

and the DWSRF. A detailed analysis of

these impacts is presented in the

Regulatory Impact Analysis of the GWR

(US EPA, 1999a).

The first measure of disproportionate

impact considers the cost incurred by

small and large systems. As a group,

small systems will experience a greater

impact than large systems under the

GWR. The higher cost to the small

ground water systems is mostly

attributable to the large number of these

types of systems (i.e., 99% of ground

water systems serve <10,000). Other

reasons for the disparity include: (1)

Large systems are more likely to already

disinfect their ground water

(disinfection exempts a system from

triggered and routine monitoring), (2)

large systems typically have greater

technical and operational expertise, and

(3) they are more likely to engage in

source water protection programs. The

potential economic impact among the

small systems will be the greatest for

systems serving less than 100 persons,

as shown in Table VI–4.

TABLE VI–4.—AVERAGE ANNUAL HOUSEHOLD COSTS FOR GWR OPTIONS FOR CWS TAKING CORRECTIVE ACTION OR

FIXING SIGNIFICANT DEFECTS

Size categories Sanitary survey

option

Sanitary survey

and triggered

monitoring option

Multi-barrier option

(proposed)

Across-the-board

disinfection option

100 ........................................................................................... 29.86 67.19 62.48 191.87

101–500 ................................................................................... 11.23 15.02 18.95 81.38

501–1,000 ................................................................................ 5.72 6.29 6.25 38.79

1,001–3,300 ............................................................................. 2.99 2.91 3.39 23.45

3,301–10,000 ........................................................................... 1.39 1.46 2.74 16.78

10,001–50,000 ......................................................................... 0.62 0.59 0.62 4.87

50,001–100,000 ....................................................................... 0.30 0.70 1.01 10.37

100,001–1,000,000 .................................................................. 0.32 0.20 0.27 1.66

Average .................................................................................... 2.45 3.34 3.86 19.37

The second measure of impact is the

relative total cost to privately owned

water systems compared to that

incurred by publicly owned water

systems. The majority of the small

systems are privately-owned (61% of

the total). As a result, privately-owned

systems as a group will have a slightly

larger share of the total costs of the rule.

However, EPA has no basis for

expecting cost per-system to differ

systematically with ownership.

The third measure, household costs,

can also be used to gauge the impact of

a regulation and to determine whether

there are disproportionately high

impacts in particular segments of the

population. Table VI–4 shows

household costs by system size for each

rule component. On average, annual

household costs increases attributable to

the first three rule options range from

$2.45 to $3.86 (Table VI–4). For these

three options, 90 percent of households

will face less than a $5 increase in

annual household costs. The most

expensive option, Across-the-Board

Disinfection, results in the highest

average annual household costs of

$19.37. However, household costs

increase across all options for those

households served by the smallest sized

systems. This occurs because they serve

fewer households, and as a result, there

are fewer households to share the

system’s compliance costs.

d. Macro-economic Effects

Under UMRA section 202, EPA is

required to estimate the potential

macro-economic effects of the

regulation. These types of effects

include those on productivity, economic

growth, full employment, creation of

productive jobs, and international

competitiveness. Macro-economic

effects tend to be measurable in

nationwide econometric models only if

the economic impact of the regulation

reaches 0.25 percent to 0.5 percent of

Gross Domestic Product (GDP). In 1998,

real GDP was $7,552 billion, so a rule

would have to cost at least $18 billion

to have a measurable effect. A regulation

with a smaller aggregate effect is

unlikely to have any measurable impact

unless it is highly focused on a

particular geographic region or

economic sector. The macro-economic

effects on the national economy from

the GWR should not have a measurable

effect because the total annual costs for

the proposed option range from $183

million to $199 million per year using

a three and seven percent discount rate.

Even the most expensive option, Acrossthe-Board Disinfection falls below the

measurable threshold. The costs are not

expected to be highly focused on a

particular geographic region or sector.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30259

e. Summary of EPA’s Consultation With

State, Local, and Tribal Governments

and Their Concerns

Consistent with the intergovernmental

consultation provisions of section 204 of

UMRA, EPA has initiated consultations

with the governmental entities affected

by this rule. EPA held four public

meetings for all stakeholders and three

Association of State Drinking Water

Administrators early involvement

meetings. 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. A more

detailed description of the SBREFA

process can be found in section VI.A. of

this preamble. 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. Twelve State

drinking water representatives also

participated in the Agency’s GWR

workgroup.

In addition to these consultations,

EPA circulated a draft of this proposed

rule and requested comment from the

public through an informal process.

Specifically, on February 3, 1999, EPA

posted on the EPA’s Internet web page

and mailed out over 300 copies of the

draft to people who had attended the

1997 and 1998 public stakeholder

meetings as well as people on the EPA

workgroup. EPA received 80 letters or

electronic responses to this draft: 34

from State government (representing 30

different States), 26 from local

governments, ten from trade

associations, six from Federal

government agencies, and four from

other people/organizations. No

comments were received from tribal

governments. EPA reviewed the

comments carefully and considered

their merit. Today’s proposal reflects

many of the commenters’ points and

suggestions. For example, numerous

commenters felt that proposing a

requirement to monitor source water

using coliphage at this time was

premature based on currently available

data. EPA has recently completed round

robin testing of coliphage methods and

is requesting comment on the use of

these methods.

To inform and involve tribal

governments in the rulemaking process,

EPA presented the GWR at the 16th

Annual Consumer Conference of the

National Indian Health Board, at the

annual conference of the National Tribal

Environmental Council, and at an EPA

Office of Ground Water and Drinking

Water (OGWDW)/Inter Tribal Council of

Arizona, Inc. tribal consultation

meeting. Over 900 attendees

representing Tribes from across the

country attended the National Indian

Health Board’s Consumer Conference

and over 100 Tribes were represented at

the annual conference of the National

Tribal Environmental Council. At both

conferences, an EPA representative

conducted two workshops on EPA’s

drinking water program and upcoming

regulations, including the GWR.

Comments received from tribal

governments regarding the GWR

focused on concerns and some

opposition to mandatory disinfection for

ground water systems. They also

suggested that any waiver process be

adequately characterized by guidance

and simple to implement. EPA agrees

with concerns of Tribes and has

designed the proposed GWR so that

disinfection is not mandatory. Systems

will have the opportunity to correct

significant deficiencies, eliminate the

source of contamination, obtain a new

source of water, or install disinfection to

achieve 4-log inactivation or removal of

virus. However, some systems in

coordination with the primacy agent or

State, might choose disinfection over

these other options because it may be

the least costly alternative.

At the OGWDW/Inter Tribal Council

of Arizona meeting, representatives

from 15 Tribes participated. In addition,

over 500 Tribes and tribal organizations

were sent the presentation materials and

meeting summary. Because many Tribes

have ground water systems, participants

expressed concerns over some elements

of the rule. Specifically, they had

concerns about how the primacy agent

would determine significant

deficiencies identified in a sanitary

survey and how the sensitivity

assessment would be conducted.

Because no Tribes currently have

primacy, EPA is the primacy agent and

will identify significant deficiencies as

part of sanitary surveys and conduct the

hydrogeologic sensitivity assessment as

outlined in section III. A. and III.B. of

this preamble.

The Agency believes the proposed

option in the GWR will provide public

health benefits to individuals by

reducing their exposure to fecal

contamination through targeted

expenditures to address significant

deficiencies or fecal contamination. As

discussed earlier in paragraph IV.C.1.c,

over 90 percent of households will incur

additional costs of less than $3.00 per

month based on EPA’s proposed

regulatory approach. EPA will consider

other options for the final rule as

outlined in this proposal and discussed

next.

f. Regulatory Alternatives Considered

As required under section 205 of the

UMRA, EPA considered several

regulatory alternatives and numerous

methods to identify ground water

systems most at risk to microbial

contamination. A detailed discussion of

these alternatives can be found in

section V of the preamble and also in

the RIA for the GWR(US EPA, 1999a).

Today’s proposal also seeks comment

on many regulatory options that EPA

will consider for the final rule.

g. Selection of the Least Costly, Most

Cost-Effective or Least Burdensome

Alternative That Achieves the

Objectives of the Rule

As discussed earlier, EPA has

considered various regulatory options

that would reduce microbial

contamination in ground water systems.

EPA believes that the proposed option

as described in today’s rule, is the most

cost effective option that achieves the

rule’s objective to reduce the risk of

illness and death from microbial

contamination in PWS relying on

ground water. This option is a targeted

approach where costs are driven by the

number of systems having to fix fecal

contamination problems and correct

significant deficiencies that could lead

to fecal contamination. EPA requests

comment on how possible modifications

to the proposed option, as outlined in

section III of the preamble, may affect

not only the cost but also the objectives

of this rule.

3. Impacts on Small Governments

In developing this rule, EPA

consulted with small governments to

address impacts of regulatory

requirements in the rule that might

significantly or uniquely affect small

governments. In preparation for the

proposed GWR, EPA conducted an

analysis on small government impacts

and included small government officials

or their designated representatives in

the rulemaking process. As discussed

previously, a variety of stakeholders,

including small governments, had the

opportunity for timely and meaningful

participation in the regulatory

30260 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

development process through the

SBREFA process, public stakeholder

meetings, and tribal meetings.

Representatives of small governments

took part in the SBREFA process for this

rulemaking and they also attended

public stakeholder meetings. Through

such participation and exchange, EPA

notified some potentially affected small

governments of requirements under

consideration and provided officials of

affected small governments with an

opportunity to have meaningful and

timely input into the development of

regulatory proposals. A more detailed

discussion of the SBREFA process and

stakeholder meetings can be found in

section VI.A. and section VI.C.2.e,

respectively.

In addition, EPA will educate, inform,

and advise small systems including

those operated by small government

about GWR requirements. One of the

most important components of this

process will be the Small Entity

Compliance Guide which is required by

the SBREFA of 1996. This plain-English

guide will explain what actions a small

entity must take to comply with the

rule. Also, the Agency is developing fact

sheets that concisely describe various

aspects and requirements of the GWR.

D. National Technology Transfer and

Advancement Act

Section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (‘‘NTTAA’’), Pub L. No.

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 the Office of

Management and Budget (OMB),

explanations when the Agency decides

not to use available and applicable

voluntary consensus standards.

EPA also notes that the Agency plans

to implement in the future a

performance-based measurement system

(PBMS) that would allow the option of

using either performance criteria or

reference methods in its drinking water

regulatory programs. The Agency is

determining the specific steps necessary

to implement PBMS in its programs.

Final decisions have not yet been made

concerning the implementation of

PBMS in water programs. However, EPA

is evaluating what relevant performance

characteristics should be specified for

monitoring methods used in the water

programs under a PBMS approach to

ensure adequate data quality. EPA

would then specify performance

requirements in its regulations to ensure

that any method used for determination

of a regulated analyte is at least

equivalent to the performance achieved

by other currently approved methods.

Once EPA has made its final

determinations regarding

implementation of PBMS in programs

under the Safe Drinking Water Act, EPA

would incorporate specific provisions of

PBMS into its regulations, which may

include specification of the performance

characteristics for measurement of

regulated contaminants in the drinking

water program regulations.

1. Microbial Monitoring Methods

The proposed rulemaking involves

technical standards. Ground water

systems that are identified by the State

as having hydrogeologically sensitive

wells as described in §§ 142.16(k)(3) and

141.403(a), and ground water systems

that have a TCR positive sample as

described in § 141.403(b) of today’s

proposed rule must sample and test

their source water. GWSs must test for

at least one of the following fecal

indicators: E. coli, enterococci and

coliphage using one of the methods in

§ 141.403(d) and discussed in greater

detail in III.D.4. Table VI–5 lists the

microbial methods which must be used

for source water monitoring.

EPA proposes to use several approved

methods. For testing E. coli and

enterococci, the methods in § 141.403(d)

are either consensus methods or new

methods that EPA has recently

approved for drinking water monitoring

with the exception of Enterolert (a

method for enterococci) for which EPA

is proposing approval through this

rulemaking. EPA is also proposing

testing source waters for the presence

for coliphage. EPA proposes to use EPA

Method 1601: Two-Step Enrichment

Presence-Absence Procedure and EPA

Method 1602: Single Agar layer

Procedure.

While the Agency identified

Standards Methods, Method 9211D

Coliphage Detection (20th edition of

Standard Methods for the Examination

of Water and Wastewater) as being

potentially applicable, EPA does not

propose to use it in this rulemaking. The

use of this voluntary consensus

standard would not meet the Agency’s

needs because the method does not

detect male specific coliphage, the

sample volume is inappropriately small

(20 ml versus the GWR’s proposed 100

ml sample requirement), and according

to the method, the sensitivity may not

be high enough to detect one coliphage

in a 100 ml sample. EPA welcomes

comments on this aspect of the

proposed rulemaking and, specifically,

invites the public to identify

potentially-applicable voluntary

consensus standards and to explain why

such standards should be used in this

regulation.

TABLE VI–5.—MICROBIAL METHODS

Analytical methods for source water monitoring

Indicator Method1

E. coli ............. Colilert Test (Method

9223B) 2 3

Colisure Test (Method

9223B) 2 3

Membrane Filter Method

with MI Agar 4 5

m-ColiBlue24 Test 4 6

E*Colite Test 4 7

May also use the EC–MUG

(Method 9212F) 2 and NA–

MUG (Method 9222G) 2 E.

coli confirmation step

§ 141.21(f)(6) after the

EPA approved Total Coliform methods in

§ 141.21(f)(3)

enterococci ..... Multiple-Tube Tech. (Method

9230B) 1

Membrane Filter Tech.

(Method 9230C) 1 8

Enterolert 3

Coliphage ....... EPA Method 1601: TwoStep Enrichment Presence-Absence Procedure 9

EPA Method 1602: Single

Agar layer Procedure 9

1The time from sample collection to initiation of analysis may not exceed 30 hours.

Systems are encouraged but not required to

hold samples below 10 °C during transit. 2 Methods are approved and described in

Standard Methods for the Examination of

Water and Wastewater (20th edition). 3 Medium available through IDEXX Laboratories, Inc., One IDEXX Drive, Westbrook,

Maine 04092. 4EPA approved drinking water methods.

5Brenner, K.P., C.C. Rankin, Y.R. Roybal,

G.N. Stelma, P.V. Scarpino, and A.P. Dufour.

1993. New medium for the simultaneous detection of total coliforms and Escherichia coli

in water. Appl. Environ. Microbiol. 59:3534–

3544. 6 Hach Company, 100 Dayton Ave., Ames,

IA 50010. 7 Charm Sciences, Inc., 36 Franklin St.,

Malden, MA 02148–4120. 8Proposed for EPA approval, EPA Method

1600: MF Test Method for enterococci in

Water (EPA–821–R–97–004 (May 1997)) is an

approved variation of Standard Method

9230C. 9Proposed for EPA approval are EPA Methods 1601 and 1602, which are available from

the EPA’s Water Resources Center, Mail

code: RC–4100, 1200 Pennsylvania Ave. NW,

Washington, DC 20460.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30261

E. Executive Order 12866: Regulatory

Planning and Review

Under Executive Order 12866, (58 FR

51,735,October 4,1993) the Agency must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

OMB review and the requirements of

the Executive Order. The Order defines

‘‘significant regulatory action’’ as one

that is likely to result in a rule that may:

(1) Have an annual effect on the

economy of $100 million or more or

adversely affect in a material way the

economy, a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local, or tribal governments or

communities; (2) create a serious

inconsistency or otherwise interfere

with an action taken or planned by

another agency; (3) materially alter the

budgetary impact of entitlement, grants,

user fees, or loan programs or the rights

and obligations of recipients thereof; or

(4) raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in the Executive Order.

Pursuant to the terms of Executive

Order 12866, EPA has determined that

this rule is a ‘‘significant regulatory

action’’. As such, this action was

submitted to OMB for review. Changes

made in response to OMB suggestions or

recommendations are documented in

the public record.

F. Executive Order 12898:

Environmental Justice

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 Agency

has considered environmental justice

issues concerning the potential impacts

of this action and has consulted with

minority and low-income stakeholders.

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.

There are two aspects of today’s

proposed rule that relate specifically to

this policy: the overall nature of the

rule, and the convening of a stakeholder

meeting specifically to address

environmental justice issues. The GWR

applies to all public water systems:

community water systems, nontransient

noncommunity water systems, and

transient noncommunity water systems

that use ground water as their source

water. Consequently, the health

protection benefits provided by this

proposal are equal across all income and

minority groups served by these

systems. Existing regulations such as the

SWTR and IESWTR provide similar

health benefit protection to

communities that use surface water or

ground water under the direct influence

of surface water.

As part of EPA’s responsibilities to

comply with Executive Order 12898, 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 sub-populations, minority

populations, and low-income

populations. Topics discussed included

treatment techniques, costs and benefits,

data quality, health effects, and the

regulatory process. Participants

included national, State, tribal,

municipal, and individual stakeholders.

EPA conducted the meetings by video

conference call with participants in

eleven cities. This meeting was a

continuation of stakeholder meetings

that started in 1995 to obtain input on

the Agency’s drinking water programs.

The major objectives for the March 12,

1998 meeting were: solicit ideas from

environmental justice (EJ) stakeholders

on known issues concerning current

drinking water regulatory efforts;

identify key issues of concern to EJ

stakeholders; and receive suggestions

from EJ stakeholders concerning ways to

increase representation of EJ

communities in EPA’s Office of Water

regulatory efforts. In addition, EPA

developed a plain-English guide

specifically for this meeting to assist

stakeholders in understanding the

multiple and sometimes complex

drinking water issues.

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 ‘‘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.

This proposed rule is subject to this

Executive Order because it is an

economically significant regulatory

action as defined by Executive Order

12866, and EPA believes that the

environmental health or safety risk

addressed by this action may have a

disproportionate effect on children.

Accordingly, EPA has evaluated the

environmental health or safety effects of

viruses on children. The results of this

evaluation are contained in section II.E.

of the preamble and in the RIA for

today’s rule (US EPA, 1999a). A copy of

RIA and its supporting documents have

been placed in the Office of Water

docket for this proposal.

1. Risk of Viral Illness to Children and

Pregnant Women

The risk of illness and death due to

viral contamination of drinking water

depends on several factors, including

the age and the immune status of the

exposed individual. Two groups that are

at increased risk of illness and mortality

due to waterborne pathogens are

children and pregnant women (Gerba et

al., 1996). For example, rotavirus

infections can occur in people of all

ages, however they primarily affect

young children (US EPA, 1999b). Infants

and young children have higher rates of

infection and disease from enteroviruses

than other age groups (US EPA, 1999b).

Several viruses 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 paralytic

polio, heart disease, encephalitis,

hemorrhagic conjunctivitis, hand-footand-mouth disease and diabetes mellitis

(CDC, 1997; Modlin, 1997; Melnick,

1996; Cherry, 1995; Berlin and

Rorabaugh, 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 (US EPA, 1999c).

Coxsackievirus and echovirus may be

transmitted from the mother to the child

in utero (Gerba et al., 1996).

To comply with Executive Order

13045, EPA calculated the baseline risk

(e.g., risk without this rule) and withrule reduction of risk from waterborne

illness and mortality for children. To

address the disproportionate risk of

waterborne illness and mortality to

children under this rulemaking, EPA

applied age-specific parameters

regarding morbidity to the risk

assessment. The risk assessment first

30262 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

extracted the proportion of the

population that falls into several age

categories that may be more or less

susceptible to waterborne viral illness

than the general population. The

extraction was done separately for two

model viruses. Bacterial illnesses are

not addressed in this analysis, however,

EPA estimates that bacterial illnesses

account for an additional 20% of viral

illnesses.

When assessing the risk of illness due

to viruses of low-to-medium infectivity

(using echovirus as a surrogate), the age

categories used were less than one

month of age, one month to five years

of age, five to sixteen years of age and

greater than sixteen years of age. It was

assumed that 50% of children less than

five years old would become ill once

infected with low-to-medium infectivity

viruses; while 57% of children five

years to sixteen years of age and 33% of

people over sixteen would become ill

once infected. This estimate was based

on a community-wide echovirus type 30

epidemic (Hall, 1970). See Appendix A

of the RIA.

When assessing the risk of illness due

to viruses of high infectivity (using

rotavirus as a surrogate) the age

categories used were less than two years

of age, two to five years of age, five to

sixteen years old and greater than

sixteen years old. It was assumed that

88% of children less than two years old

would become ill once infected with

high infectivity viruses; while 40% was

assumed for everyone else. The

morbidity rates for high infectivity

viruses were based on data from

Kapikian and Chanock (1996) for

children less than two. For other age

categories, EPA has conservatively

estimated a morbidity of 10 based upon

studies of rotavirus illness in

households with newborn children

(Wenman et al., 1979) and of an

outbreak in an isolated community

(Foster et. al., 1980). See Appendix A of

the RIA.

In addition to illness, EPA also

considered child mortality attributable

to waterborne microbial illness. For

low-to-medium infectivity viruses,

0.92% of children less than one month

of age who become ill were assumed to

die based on information from Jenista et

al., (1984) and Modlin (1986), while

.041% of people greater than one month

old who become ill were assumed to

die. For viruses of high infectivity,

0.00073% of infected children less than

four years old were assumed to die

(Tucker et al., 1998). The low-tomedium infectivity viruses result in a

higher mortality rate than the high

infectivity viruses because the low-tomedium infectivity viruses cause more

serious health effects.

The proposed GWR specifically

targets systems with existing or

potential fecal contamination, including

viral contamination. To estimate the

benefits to children from today’s

proposed rule, the Agency calculated

the number of illnesses and deaths

avoided by the rule for the children less

than 5 years old and for children

between the ages of 5 and 16. Table VI–

6 presents a summary of these estimates.

Overall, the proposed rule would result

in 26,566 less illnesses caused by

viruses per year occurring in children

16 years of age and less. The proposed

rule is also expected to result in 2 less

deaths per year due to viral illness

among children aged 16 or less.

TABLE VI–6.—REDUCTIONS OF VIRAL ILLNESS AND DEATH IN CHILDREN RESULTING FROM VARIOUS REGULATORY

APPROACHES

Options Illness reduction

(ages 0–5)

Death reduction

(ages 0–5)

Illness reduction

(5–16 years old)

Death reduction

(5–16 years old)

Sanitary Survey Only ....................................................... 2,292 0 1,773 0

Sanitary Survey and Triggered Monitoring ...................... 13,044 1 9,974 1

Multi-barrier (Proposed) ................................................... 15,058 1 11,508 1

Across-the-board Disinfection .......................................... 21,125 1 16,059 2

The Agency believes the proposed

multi-barrier approach will provide the

most cost-effective method of reducing

viral and bacterial illness in children

that results from contaminated ground

water. The proposed option will reduce

3,500 more cases of viral illness in

children each year than the sanitary

survey and triggered monitoring option.

This additional reduction is obtained

with only a slightly larger increase in

total annual costs. Conversely, the

additional reductions in illness gained

with the across-the-board option comes

at a much higher cost. It is estimated

that the across-the-board option will

cost approximately $12,000 more per

case of illness avoided than the multibarrier approach.

2. Full Analysis of the Microbial Risk

Assessment

A full analysis of the microbial risk

assessment is provided in the Appendix

to the RIA for the proposed GWR, and

a summary is provided in this preamble

(see section II.E.).

The public is invited to submit or

identify peer-reviewed studies and data,

of which EPA may not be aware, that

assessed results of early life exposure to

viruses and bacteria.

H. Consultations with the Science

Advisory Board, National Drinking

Water Advisory Council, and the

Secretary of Health and Human Services

In accordance with section 1412 (d)

and (e) of the SDWA, the Agency did

consult with the Science Advisory

Board and will request comment from

the National Drinking Water Advisory

Council (NDWAC) and the Secretary of

Health and Human Services on the

proposed rule.

I. Executive Order on 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’’. Under

section 6 of Executive Order 13132, EPA

may not issue a regulation that has

Federalism 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 State and

local governments, or EPA consults with

State and local officials early in the

process of developing the proposed

regulation. EPA also may not issue a

regulation that has Federalism

implications and that preempts State

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30263

law, unless the Agency consults with

State and local officials early in the

process of developing the proposed

regulation.

If EPA complies by consulting,

Executive Order 13132 requires EPA to

provide to the Office of Management

and Budget (OMB), in a separately

identified section of the preamble to the

final rule, a Federalism summary impact

statement (FSIS). The FSIS must include

a description of the extent of EPA’s

prior consultation with State and local

officials, a summary of the nature of

their concerns and the Agency’s

position supporting the need to issue

the regulation, and a statement of the

extent to which the concerns of State

and local officials have been met. Also,

when EPA transmits a draft final rule

with Federalism implications to OMB

for review pursuant to Executive Order

12866, EPA must include a certification

from the Agency’s Federalism Official

stating that EPA has met the

requirements of Executive Order 13132

in a meaningful and timely manner.

EPA has concluded that this proposed

rule may have Federalism implications

since it may impose substantial direct

compliance costs on local governments,

and the Federal government will not

provide the funds necessary to pay

those cost. Accordingly, EPA provides

the following FSIS as required by

section 6(b) of Executive Order 13132.

As discussed in section I.A., EPA met

with a variety of State and local

representatives including several local

elected officials, who provided

meaningful and timely input in the

development of the proposed rule.

Summaries of the meetings have been

included in the public record for this

proposed rulemaking. EPA consulted

extensively with State, local, and tribal

governments. For example, four public

stakeholder meetings were held in

Washington, DC, Portland, Oregon,

Madison Wisconsin and Dallas, Texas.

EPA also held three early involvement

meetings with the Association of State

Drinking Water Administrators. Several

key issues were raised by stakeholders

regarding the GWR provisions, many of

which were related to reducing burden

and maintaining flexibility. The Office

of Water was able to reduce burden and

increase flexibility by creating a targeted

risk based approach which builds upon

existing State programs. It should be

noted that this rule is important because

it will reduce the incidence of fecally

contaminated drinking water supplies

by requiring corrective actions for

fecally contaminated systems or systems

with a significant risk of fecal

contamination resulting in a reduced

waterborne illness. Because

consultation on this proposed rule

occurred before the November 2, 1999,

effective date of Executive Order 13132,

EPA will initiate discussions with State

and local elected officials regarding the

implications of this rule during the

public comment period.

J. Executive Order 13084: Consultation

and Coordination With Indian Tribal

Governments

Under Executive Order 13084, EPA

may not issue a regulation that is not

required by statute, that significantly or

uniquely affects the communities of

Indian tribal governments, and that

imposes substantial direct compliance

costs on those communities, unless the

Federal government provides the funds

necessary to pay the direct compliance

costs incurred by the tribal

governments, or EPA consults with

those governments. If EPA complies by

consulting, Executive Order 13084

requires EPA to provide to the OMB, in

a separately identified section of the

preamble to the rule, a description of

the extent of EPA’s prior consultation

with representatives of affected tribal

governments, a summary of the nature

of their concerns, and a statement

supporting the need to issue the

regulation. In addition, Executive Order

13084 requires EPA to develop an

effective process permitting elected

officials and other representatives of

Indian tribal governments ‘‘to provide

meaningful and timely input in the

development of regulatory policies on

matters that significantly or uniquely

affect their communities.’’

EPA has concluded that this rule will

significantly affect communities of

Indian tribal governments because 92

percent of PWSs in Indian Country are

ground water systems. It will also

impose substantial direct compliance

costs on such communities, and the

Federal government will not provide the

funds necessary to pay the direct costs

incurred by the tribal governments in

complying with the rule. In developing

this rule, EPA consulted with

representatives of tribal governments

pursuant to Executive Order 13084.

EPA’s consultation, the nature of the

tribal governments’ concerns, and EPA’s

position supporting the need for this

rule are discussed in section VI.C.

which addresses compliance with

UMRA.

As described in section VI.C.2.e. of

the UMRA discussion, EPA held

extensive public meetings that provided

the opportunity for meaningful and

timely input in the development of the

proposed rule. Summaries of the

meetings have been included in the

Office of Water public docket for this

rulemaking. In addition, the Agency

presented the rule and asked for

comment at three tribal conferences.

Two consultations took place at national

conferences; one for the National Indian

Health Board and the other for the

National Tribal Environmental Council.

The third consultation was conducted

in conjunction with the Inter-Tribal

Council of Arizona, Inc. A more detailed

discussion of these consultations can be

found in the UMRA consultation section

(section VI.C.2.c.).

K. Plain Language

Executive Order 12866 and the

President’s memorandum of June 1,

1998, require each agency to write its

rules in plain language. EPA invites

comments on how to make this

proposed rule easier to understand. For

example: Has EPA organized the

material to suit commenters’ needs? Are

the requirements in the rule clearly

stated? Does the rule contain technical

language or jargon that is not clear?

Would a different format (grouping and

order of sections, use of headings,

paragraphs) make the rule easier to

understand? Would shorter sections

make this rule easier to understand?

Could EPA improve clarity by adding

tables, lists, or diagrams? What else

could EPA do to make the rule easier to

understand?

VII. Public Comment Procedures

EPA invites you to provide your

views on this proposal, approaches we

have not considered, the potential

impacts of the various options

(including possible unintended

consequences), and any data or

information that you would like the

Agency to consider. Many of the

sections within today’s proposed rule

contain ‘‘Request for Comment’’

portions which the Agency is also

interested in receiving comment on.

A. Deadlines for Comment

Send your comments on or before July

10, 2000. Comments received after this

date may not be considered in decision

making on the proposed rule.

B. Where To Send Comment

Send an original and 3 copies of your

comments and enclosures (including

references) to W–98–23 Comment Clerk,

Water Docket (MC4101), USEPA, 1200

Pennsylvania Ave., NW, Washington DC

20460. Hand deliveries should be

delivered to the Comment Clerk, Water

Docket (MC4101), USEPA 401 M ,

Washington, D.C. 20460. Comments

may also be submitted electronically to

ow-docket@epamail.epa.gov. Electronic

comments must be submitted as an

30264 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

ASCII, WP5.1, WP6.1 or WP8 file

avoiding the use of special characters

and form of encryption. Electronic

comments must be identified by the

docket number W–98–23. Comments

and data will also be accepted on disks

in WP 5.1, 6.1, 8 or ASCII file format.

Electronic comments on this notice may

be filed online at many Federal

Depository Libraries. Those who

comment and want EPA to acknowledge

receipt of their comments must enclose

a self-addressed stamped envelope. No

facsimiles (faxes) will be accepted.

Comments may also be submitted

electronically to owdocket@epamail.epa.gov.

C. Guidelines for Commenting

To ensure that EPA can read,

understand and therefore properly

respond to comments, the Agency

would prefer that commenters cite,

where possible, the paragraph(s) or

sections in the notice or supporting

documents to which each comment

refers. Commenters should use a

separate paragraph for each issue

discussed. Note that the Agency is not

soliciting comment on, nor will it

respond to, comments on previously

published regulatory language that is

included in this notice to ease the

reader’s understanding of proposed

language. You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide technical information and/

or data to support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate.

5. Indicate what you support, as well

as what you disagree with.

6. Provide specific examples to

illustrate your concerns.

7. Make sure to submit your

comments by the deadline in this

proposed rule.

8. At the beginning of your comments

(e.g., as part of the ‘‘Subject’’ heading),

be sure to properly identify the

document you are commenting on. You

can do this by providing the docket

control number assigned to the

proposed rule, along with the name,

date, and Federal Register citation.

VIII. References

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

LeChevallier, Rosen, Jeffery S. and C.P.

Gerba. 1999. Occurrence of viruses in

ground water in the United States.

American Water Works Association

Research Foundation. Denver, CO, 189 p.

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

LeChevallier. 1999. A Strategy for

Detection of Viruses in Groundwater by

PCR. Applied and Environmental

Microbiology Vol 65(2):444–449.

Adham S.S., R.S. Trussell, P.F. Gagliardo,

and R.R. Trussell. 1998. Rejection of MS–

2 Virus by RO Membranes. JAWWA.

90(9):130–135.

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, Vol. 87, No. 4,

pp.580–584.

Association of State Drinking Water

Administrators. 1998. Results and Analysis

of ASDWA Survey of BMPs in Community

Ground Water Systems. April 1998.

AWWA. 1998. Unpublished Data from EPA

Analysis of Data from the AWWA

Disinfection Practices Survey for Small

Ground Water Systems.

Battigelli, D.A.1999. Monitoring ground

waters in Wisconsin, Minnesota, and

Maryland for enteric viruses and candidate

viral indicators. Unpublished report,

February 23, 1999.

Battigelli, D.A., M.D. Sobsey, and D.C. Lobe.

1993. The Inactivation of Hepatitis A Virus

and Other Model Viruses by UV

Irradiation. Water Sci. Tech. 27(3–4): pp.

339–342.

Becker, Matthew W., Paul W. Reimus and

Peter Vilks. 1998. Transport and

Attenuation of Carboxylate-Modified Latex

Microspheres in Fractured Rock Laboratory

and Field Tracer Tests. Ground Water, V.

37(3) 387–395.

Bennett, J.V., S.D Holber, M.F. Rogers, and

S.L. Solomon. 1987. Infectious and

parasitic diseases. Am. J. Prev. Med. 3:102–

114. In: R.W. Amler and H.B. Dull (Eds.),

closing the gap: the burden of unnecessary

illness. Oxford University Press. pp. 112–

114.

Berlin, L.E. and M.L. Rorabaugh. 1993.

Aseptic Meningitis in Infants < 2 Years of

Age: Diagnosis and Etiology. J. Infect. Dis.

168:888–892.

Boring, J.R., Martin, W.T. and Elliott, L.M.

1971. ‘‘Isolation of Salmonella

typhimurium from municipal water,

Riverside, California, 1965.’’ Amer. J.

Epidem., Vol. 93, pp 49–54.

Bouchier, I.A.D. 1998. Cryptosporidium in

Water Supplies, Report on the Group of

Experts, UK Dept of the Environment,

Transport and the Regions.

www.dwi.detr.gov.uk/Crypto.

Budnick, G.E., R.T. Howard and D.R. Mayo.

1996. Evaluation of Enterolert for

Enumeration of enterococci in Recreational

Waters. Appl Environ Microbiol 62:3881–

3884.

Canter, L. and R.C. Knox. 1984. Evaluation of

septic tank system effects on ground water

quality. U.S. Environmental Protection

Agency pub. No. EPA–600/2–84–107.

CDC. 1999. Escherichia coli O157:H7.

Factsheet prepared by CDC (http://

www.cdc.gov/ncidod/dbmd/disease info/

escherichiacolit.htm).

CDC. 1997. ‘‘Paralytic Poliomyelitis United

States, 1980–1994.’’MMWR Weekly.

46(04);79–83. (http://www.cdc.gov/epo/

mmwr/preview/mmwrhtm/00045949.htm).

CEOH. Consultants in Epidemiology and

Occupation Health, Inc. 1998. Preliminary

draft report. Untitled. July.

Chang, J.C., Susan F. Ossoff, David C. Lobe,

Mark H. Dorfman, Constance M. Dumais,

Robert G. Qualls and J. Donald Johnson.

1985. UV Inactivation of Pathogenic and

Indicator Microorganisms. Appl. Environ.

Microbiol. Vol. 49, pp.1361–1365.

Cherry, J.D. 1995. Enteroviruses. In:

Remington and Klein. eds. Infectious

Diseases of the Fetus and Newborn Infant.

Philadelphia: W.B. Saunders. pp.404–446.

Christian, R.. and W. Pipes. 1983. Frequency

Distribution of Coliforms in Water

Distribution Systems. Appl. Environ.

Microbiol. 45:603–609.

Craun, Gunther. 1998. Memorandum from G.

Craun to U.S. Environmental Protection

Agency (M. Negro), dated 10/26/98.

Waterborne outbreak data 1971–1996,

community and noncommunity water

systems.

Craun, G.F. and R. Calderon. 1996. Microbial

Risks in Ground water Systems,

Epidemiology of Waterborne Outbreaks. in

Under the Microscope, Proceedings of the

Ground water Foundations’s 12th Annual

Fall Symposium, Sept. 5&6, 1996, Boston,

MA. Amer. Water Works Association,

Denver, CO, pp. 9–15.

Craun, G. 1994. Memorandum from G. Craun

to U.S. Environmental Protection Agency

(P. Berger), dated 1/19/94. Waterborne

outbreak data 1981–1990, community

water systems.

Craun, G. 1991. Causes of Waterborne

Outbreaks in the United States. Wat. Sci.

Technol 24:17–20.

CWSS. 1995. Unpublished Data.

Dalldorf, G., and J.L. Melnick. 1965.

Coxsackieviruses. In: Horsefall, F.L. and L.

Tamms. eds. Viral and Rickettsial

Infections of Man. 4th ed. Philadelphia.

J.B. Lippincott. pp. 474–511.

Davis, J.V. and E.C. Witt, III. 1999.

Microbiological Quality of Public-Water

Supplies in Ozark Plateaus Aquifer

System, Missouri, USGS Water-Resources

Investigations Report 99–XXXX

Davis, J.V. and E.C. Witt. 1998.

Microbiological Quality of Public Water

Supplies in the Ozark Plateaus Aquifer

System Missouri. U.S.G.S. Fact Sheet 028–

98.

Doherty, K. 1998. ‘‘Status of the New England

Ground Water Viral Study.’’ in

Proceedings, American Water Works

Association Annual Meeting, Dallas, Texas,

June 23, 1998. American Water Works

Association, Denver.

Femmer, S. 1999. Microbiological Quality of

Older Wells in Public Water Supplies in

the Ozark Plateaus Aquifer System

Missouri.

Finch, G.R., C.W. Labatiuk, R.D. Helmer and

M. Belosevic. 1992. Ozone and Ozoneperoxide Disinfection of Giardia and

Viruses. AWWA Research Foundation.

Denver, CO.

Florida Department of Environmental

Protection. 1996. The State of Florida’s

Evaluation of Cross-Connection Control

Rules/Regulations in the 50 States.

Tallahassee, FL. August 1996.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30265

Foster, S.O., E.L. Palmer, G.W. Gary Jr., M.

L. Martin, K. L. Herrmann, P. Beasley and

J. Sampson. 1980. ‘‘Gastroenteritis due to

rotavirus in an isolated Pacific Island

group: an epidemic of 3,439 cases.’’ J.

Infect. Dis. 141: 32–39.

Freeze, R.A. and J.A. Cherry. 1979.

Groundwater. Prentice Hall. Englewood

Cliffs, NJ.

Fujioka, R.S. and B.S. Yoneyama. 1997.

Vulnerability to Pathogens: Water Quality

Monitoring and Assessment Study.

Unpublished report to the Honolulu Board

of Water Supply by Hawaii Water

Resources Research Center, Univ. of

Hawaii, 54 p.

Geldreich, E.E. 1996. Microbial Quality of

Water Supply in Distribution Systems.

Lewis Publishers, Boca Raton, Florida, 3

selected pages.

Geldreich, E.E., K.R. Fox, J.A. Goodrich, E.W.

Rick, R.M. Clark, and D.L. Swerdolw. 1992.

‘‘Searching for a water supply connection

in the Cabool Missouri disease outbreak of

Escherichia coli 0157:H7.’’ Water Research,

Vol. 26, No. 8, pp 1127–1137.

Gerba, C. P., J. B. Rose, and C. N. Haas, 1996.

Sensitive populations: who is at the

greatest risk? Int. J. Food Micro. 30:113–

123.

Haas, C.N. and J.B. Rose. 1995. Developing an

action level for Cryptosporidium. J.

AWWA. 87 (9):81–84.

Haas, C.N. 1993. Microbial Sampling: Is it

Better to Sample Many Times or Use Large

Samples? Water Science and Technol.

27:19–25. xxx

Ha ̈efliger, D., J. Lua ̈thy and P. Hu ̈bner. 1998.

Epidemiological Investigations After a

Local Outbreak of Enteroviral Meningitis.

Abstracts of the 98th General Meeting of

the American Society for Microbiology,

Atlanta GA May 17–21, 1998. American

Society for Microbiology, Washington D.C.

Session 225Q, Poster Q236, p. 460.

Hall, R.M.S. and M.D. Sobsey. 1993.

Inactivation of Hepatitis A Virus and MS2

by Ozone and Ozone-hydrogen Peroxide in

Buffered Water. Water Science and

Technology. 27(3/4): 371–378.

Hall, C. E., M. K. Cooney, and J. P. Fox, 1970.

The Seattle virus watch program. I.

Infection and illness experience of virus

watch families during a community-wide

epidemic of echovirus type 30 aseptic

meningitis.@ AJPH 60:1456–1465.

Hancock, C.M., J.B. Rose and M. Callahan.

1998. ‘‘Crypto and Giardia in US ground

water.’’Jour. Amer. Water Works Assoc.,

Vol. 90, pp. 58–61.

Harris GD, V.D. Adams, D.L. Sorenson and

M.S. Curtis. 1987. Ultraviolet Inactivation

of Selected Bacteria and Viruses with

Photoreactivation of the Bacteria. Water

Research. 21:687–92.

Hejkal, T.W., B. Keswick, R.L. LaBelle, C.P.

Gerba, Y. Sanchez, G. Dressman, B. Hafkin,

and J.L. Melnick. 1982. ‘‘Viruses in a

community water supply associated with

an outbreak of gastroenteritis and

infectious hepatitis.’’ JAWWA., Vol. 74, pp.

318–321.

Herbold, K., B. Flehmig and K. Botzenhart.

1989. Comparison of Ozone Inactivation, in

Flowing Water, of Hepatitis A Virus,

Poliovirus 1, and Indicator Organisms.

Appl. Environ. Microbiol. 55(11):2949–

2953.

Hopkins, R.S., P. Shilam, B. Gaspard, L.

Eisnach and R. J. Karlin. 1985. Waterborne

disease in Colorado: three years’

surveillance and 18 outbreaks. Am. J.

Public Health. 75(3):254–257.

Jacangelo, J.G., S. Adham and J.M. Laine.

1995. Application of Membrane Filtration

Techniques for Compliance with the

Surface Water and Ground Water

Treatment Rules. AWWA. Denver, CO.

Jenista, J.A., K.R. Powell, and M.A.

Menegaus. 1984. ‘‘Epidemiology of

neonatal enterovirus infection.’’ J. Pediatr.

104:685–690.

Kaneko, M. 1989. Effect of Suspended Solids

on Inactivation of Poliovirus and T–2

Phage by Ozone. Water Science and

Technology. 21(3): 215–219.

Kapikian, A.Z. and R.M. Chanock, 1996.

ARotaviruses.@ In B.N. Fields et al., eds.

Virology, 3rd Ed., Volumes 2, New York:

Raven Press, pp. 1657–1708.

Kaplan, M.H. and S.W. Klein. 1983.

Coxsackievirus Infections in Infants

Younger than Three Months of Age: A

Serious Childhood Illness. Rev. Inf. Dis.

5:1019–1033.

Kelly, S. and W.W. Sanderson. 1958. The

Effect of Chlorine in Water on Enteric

Viruses. American Journal of Public

Health. Vol. 48, No. 10, pp. 1323–1334.

Kogon, A., I. Spigland, T.E. Frothingham et

al., 1969. The virus watch program: a

continuing surveillance of viral infections

in metropolitan New York families: VII.

Observations on viral excretion,

seroimmunity, intrafamilial spread and

illness association in Coxsackie and

echovirus infections.@ Amer. J. Epidemiol.

89:51–61.

Kramer, M.H., B.L. Herwaldt, G.F. Craun,

R.L. Calderon, and D.D. Juranek. 1996.

‘‘Waterborne disease: 1993–1994.’’ Journal

AWWA, pp 67–80.

Lanfear, K.J. 1992. A Database of Nitrate in

Ground-Water Samples from the

Conterminous United States. U.S.

Geological Survey Open File Report 92–

652.

Lawson, H.W., M.M Braun, R I.M. Glass, S.

Stine, S. Monroe, H.K. Atrash, L.E. Lee,

and S.J. Englender. 1991. ‘‘Waterborne

outbreak of Norwalk virus gastroenteritis at

a southwest US resort: role of geological

formations in contamination of well

water.’’ The Lancet, Vol. 337, pp. 1200–

1204.

Lederberg, Joshua. Editor. 1992.

Encyclopedia of Microbiology. Vol 2.

Academic Press, Inc. New York.

Enteroviruses. pp. 69–75.

Lieberman, R.J., L.C. Shadix, C.P. Newport,

M.W.N. Frebis, S.E. Moyer, R.S. Safferman,

R.E. Stetler, D. Lye, G.S. Fout, and D.

Dahling. 1999. ‘‘Source water microbial

quality of some vulnerable public ground

water supplies.’’ unpublished report in

preparation.

Lieberman, R.J., L.C. Shadix, B.S. Newport,

S.R. Crout, S.E. Buescher, R.S. Safferman,

R.E. Stetler, D. Lye, G.S. Fout, and D.

Dahling. 1994. ‘‘Source water microbial

quality of some vulnerable public ground

water supplies.’’ in Proceedings, Water

Quality Technology Conference, San

Francisco, CA, October, 1994.

Malard, Florian, Jean-Louis Reygrobellet, and

Michel Soulie 1994. Transport and

Retention of Fecal Bacteria at SewagePolluted Fractured Rock Sites. J. Environ.

Qual. 23:1352–1363.

MacKenzie, W.R., N.J. Hoxie, M.E. Proctor,

M.S. Gradus, K.A. Blair, D.E. Peterson, J.J.

Kazmierczak, D.G. Addisss, K.R. Fox, J.B.

Rose and J. P. Davis. 1994. ‘‘A massive

outbreak in Milwaukee of Cryptosporidium

infection transmitted through the public

water supply.’’ New Eng. J. of Medicine,

v.331, pp. 161–167.

Melnick, J.L. 1996. Enteroviruses: Poliovirus,

Coxsackievirus, Echovirus, and Newer

Enteroviruses. In: Fields, B.N., D.M. Knipe,

and P.M. Howrey. eds. Fields Virology.

Philadelphia: Lippincott Raven Publishers.

Modlin, J.F. 1997. Enteroviruses:

Coxsackievirus, Echoviruses and Newer

Enteroviruses. In: Long, S.S., et al. eds.

Principles and Practice of Pediatric

Infectious Diseases. New York. Churchill

Livingstone.

Modlin, J.F. 1986. Perinatal Echovirus

Infection: Insights from a Literature Review

of 61 Cases of Serious Infection and 16

Outbreaks in Nurseries. Rev. Inf. Dis.

8:918–926.

Monto, A.S., J.S. Koopman, I.M. Longini, and

R.E. Isaacson, 1983. The Tecumseh study.

XII. Enteric agents in the community.

1976–1981.@ J. Inf. Dis.

Morens, D.M., M.A. Pallansch, and M.

Moore. 1991. ‘‘Polioviruses and other

enteroviruses.’’ Textbook of Human

Virology, second edition. Robert B. Belshe,

editor. St Louis: Mosby Year Book. pp.

427–497.

National Research Council. 1997. Safe Water

From Every Tap; Improving Water Service

to Small Communities. National Academy

Press, Washington D.C., 6 selected pages.

Orth, J.P., R. Netter, G. Merkl. 1997. Bacterial

and Chemical Contaminant Transport Tests

in a Confined Karst Aquifer (Danube

Valley, Swabian Jura, Germany) in Karst

Waters and Environmental Impacts. Gunay

and Johnson Editors. Balkema Rotterdam.

p. 173.

Osawa, S., K. Furuse, I. Watanabe. 1981.

Distribution of Ribonucleic Acid

Coliphages in Animals. Appl Environ.

Microbiol 41: 164–8.

Payment, P., J. Siemiatycki, L. Richardson, G.

Renaud, E. Franco, and M. Prevost. 1997.

A prospective epidemiological study of

gastrointestinal health effects due to the

consumption of drinking water. Intern.

Journ of Environ. Health Res, vol. 7, pp. 5–

31.

Perz, J.F., F.K. Ennever and S.M. Le Blancq.

1998. ‘‘Cryptosporidium in tap water;

Comparison of predicted risks with

observed levels of disease.’’ Amer. J.

Epidem., Vol. 147, pp. 289–301.

Pipes, W. and R. Christian. 1982. Sampling

Frequency—Microbiological Drinking

Water Regulation. US EPA 570/9–82–001.

US EPA Washington DC, 4 selected pages.

Quignon, F., L. Kiene, Y. Levi, M. Sardin and

L. Schwartzbrod. 1997. ‘‘Virus behavior

within a distribution system.’’ Water Sci

Technol., Vol. 35, pp. 311–318.

30266 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

Quinlan, J. F. 1989. Ground Water

Monitoring in Karst Terranes:

Recommended Protocol and Implicit

Assumptions. U.S. Environmental

Protection Agency, Environmental

Monitoring Systems Laboratory, Las Vegas,

Nev. EPA/600/X–89/050, 3 selected pages.

Regli, S., J. B. Rose, C. N. Haas and C. P.

Gerba, 1991. A Modeling the risk from

Giardia and viruses in drinking water.@

JAWWA, November, pp. 76–84.

Resolve. 1998. Subject: Stakeholder Meeting

Summary and Materials. Washington, DC.

Unpublished report. July 27, 1998.

Roessler, P.F., and B.F. Severin. 1996.

Ultraviolet Light Disinfection of Water and

Wastewater. In: Hurst, C.J. ed. Modeling

Disease Transmission and Its Prevention by

Disinfection. New York. Cambridge

University Press. pp. 313–368.

Roy, D., R.S. Engelbrecht and E.S.K. Chian.

1982. Comparative Inactivation of Six

Enteroviruses by Ozone. J. Am. Water

Works Assoc. 74:660–664.

Rusin, P.A., J.B. Rose, C.N. Haas, C.P. Gerba.

1997. Risk Assessment of Opportunistic

Bacterial Pathogens in Drinking Water.

Rev. Environ. Contam. Toxicol. Vol 152:

57–83.

Schiff, G.M., G.M. Stephanonic, E.C. Young,

D.S. Sander, J.K. Pennecamp, and R.L.

Ward.1984. Studies of Echovirus-12 in

Volunteers; Determination of Minimal

Infectious Dose and the Effect of Previous

Infection on Infectious Dose. J. Inf. Dis.

150(6):858–866.

Sinton, L.W., R.K. Finlay, L. Pang and D.M

Scott. 1997, ‘‘Transport of bacteria and

bacteriophages in irrigated effluent and

through an alluvial gravel aquifer.’’ Water,

Air and Soil Poll., Vol. 98, pp. 17–42.

Slade, R.M., M.E. Dorsey and S.L. Stewart.

1986. Hydrology and Water Quality of the

Edwards Aquifer Associated With Barton

Springs in the Austin Area Texas. U.S.

Geological Survey. Water Resources

Investigations Report 86–4036.

Smith, W.G. 1970. Coxsackie B

Myopericarditis in Adults. Am. Heart J.

80(1):34–46.

Snicer et al., 1996. Evaluation of Ultraviolet

(UV) Technology for Ground Water

Disinfection. AWWARF Draft Report.

Sobsey, M.D., T. Fuji and P.A. Shields. 1988.

Inactivation of Hepatitis A virus and Model

Viruses in Water by Free Chlorine and

Monochloramine. Water Sci. Tech. Vol. 20.

No. 11/12, pp. 385–391.

Solimena M. and P. De Camilli. 1995.

Coxsackievirus and Diabetes. Nature

Medicine. Vol 1(1):24–25.

Solo-Gabriele, H. and S. Neumeister. 1996.

‘‘US outbreaks of cryptosporidiosis.’’ Jour.

Amer. Water Works Assoc., Vol. 88, pp.76–

86.

Swerdlow, D.L., B.A. Woodruff, R.C. Brady,

P.M. Griffin, S. Tippen, H. Donnel Jr., E.

Geldreich, B.J. Payne, A. Meyer Jr., J.G.

Wells, K.D. Greene, M. Bright, N.H. Bean,

and P.A. Blake. 1992. ‘‘A waterborne

outbreak in Missouri of Escherichia coli

O157:H7 associated with bloody diarrhea

and death.’’ Annals of Internal Medicine,

Vol. 117, No. 10, pp 812–819.

Teunis, P.F.M., O.G. Van der Heijden, J.W.B.

Van der Giessen and A.H. Havelaar. 1986.

The Dose-Response Relation in Human

Volunteers for Gastro-Intestinal Pathogens.

National Institute of Public Health and the

Environment. Report #28450002.

Bilthoven, The Netherlands.

Tucker, A. W., A. C. Haddix, J. S. Bresee, R.C.

Holman, U.d. Parashar and R.I. Glass. 1998.

‘‘A Cost effectiveness analysis of a

rotavirus immunization program for the

United States.’’ JAMA. 279(17):1371–1376.

U.S. EPA. 2000a. Estimated Per Capita Water

Ingestion in the United States.

U.S. EPA. 2000b. Regulatory Impact Analysis

of the Proposed Ground Water Rule.

U.S. EPA. 1999b. Drinking Water Criteria

Document for Viruses: An Addendum.

EPA/822/R/98/042, January 15, 1999.

U.S. EPA. 1999c. Drinking Water Criteria

Document for Enteroviruses and Hepatitis

A: An Addendum. EPA/822/R/98/043,

January 15, 1999.

U.S. EPA. 1999d. Ground Water Rule

Occurrence and Monitoring Document.

U.S. EPA. 1999e. Guidance Manual for

Conducting Sanitary Surveys of Public

Water Systems; Surface Water and Ground

Water Under the Direct Influence of

Surface Water. EPA 815–R–99–016.

Washington DC.

U.S. EPA. 1999f. Baseline Profile Document

for the Ground Water Rule.

U.S. EPA. 1999g. Underground Injection

Control Regulations for Class V Injection

Wells, Revion; Final Rule. 64 FR 68546.

U.S. EPA. in prepeparation. Virus Sampling

at the US/Mexico Border. Unpublished

report by Cadmus, Inc. to the Office of

Ground Water and Drinking Water.

U.S. EPA. 1998a. Wisconsin Migrant Worker

Camp Drinking Water Quality Study.

Unpublished report prepared for US EPA

Region V, Safe Drinking Water Branch,

July, 1998, 37p.

U.S. EPA. 1998b. Ground Water Rule

Vulnerability Assessment Study, April 3,

1998. Unpublished report prepared by

International Consultants, Inc. for the

Office of Ground Water and Drinking

Water, 29 p.

U.S. EPA. 1998c. Small System Compliance

Technology List for the Surface Water

Treatment Rule and Total Coliform Rule.

EPA–815–R–98–001.

U.S. EPA. 1998d. National Primary Drinking

Water Regulations. Interim Enhanced

Surface Water Treatment Rule (IESWTR)

63 FR 69478.

U.S. EPA 1998e. National Primary Drinking

Water Regulations: Disinfectants and

Disinfection Byproducts; Final Rule.

December 16, 1998. Volume 63, Number

241. 69389–69476.

U.S. EPA 1998f. Guidance on Implementing

the Capacity Development Provisions of

the Safe Drinking Water Act Amendments

of 1996. EPA 816–R–98–006. July 1998.

U.S. EPA. 1997a. Safe Drinking Water

Information System (SDWIS).

U.S. EPA. 1997b. Guidelines for Wellhead

and Springhead Protection Area in

Carbonate Rocks. EPA 904–B–97–0003.

U.S. EPA. 1997c. Community Water System

Survey, 2 volumes EPA 815–R–97–001, US

Environmental Protection Agency,

Washington D.C.

U.S. Environmental Protection Agency

(USEPA). 1997d. State Ground Water

Management Practices—Which Practices

Are Linked to Significantly Lower Rates of

Total Coliform Rule (TCR) Violations?

Unpublished report. December 9, 1997.

U.S. Environmental Protection Agency

(USEPA). 1997e. Ground Water

Disinfection Rule Workshop on Ground

Water Protection Barrier Elements—Final

Proceedings (March 26–28, 1997)

U.S. Environmental Protection Agency

(USEPA). 1997f. Response to Congress on

the Use of Decentralized Wastewater

Treatment Systems. April 1997. EPA 832–

R–97–001b.

U.S. Environmental Protection Agency

(USEPA). 1996a. Ground Water

Disinfection and Protective Practices in the

United States. EPA Contract No. 68–C3–

0365. November 1996.

U.S. Environmental Protection Agency

(USEPA). 1996b. National Primary

Drinking Water Regulations: Monitoring

Requirements for Public Drinking Water

Supplies: Cryptosporidium, Giardia,

Viruses, Disinfection Byproducts, Water

Treatment Plant Data and Other

Information Requirements. Final Rule. Vol.

61, No. 94. May 14, 1996. 24354–24388.

U.S. Environmental Protection Agency

(USEPA). 1996c. Ground Water

Disinfection rule—Workshop on Predicting

Microbial Contamination of Ground Water

Systems—July 10–11, 1996—Proceedings

Report, September 1996.

U.S. Environmental Protection Agency

(USEPA). 1995. Office of Inspector General

Survey Report on the Cross Connections

Control Program. E1HWG4–01–0091–

5400070. May 16, 1995.

U.S. Environmental Protection Agency

(USEPA) and Association of State Drinking

Water Administrators (ASDWA). EPA/State

Joint Guidance on Sanitary Surveys.

December 1995. p.1–8.

U.S. EPA. 1993. Technologies and Costs for

Groundwater Disinfection. Office of

Ground Water and Drinking Water,

Washington, DC. Prepared by Malcolm

Pirnie, Inc., Mahwah, NJ.

U.S. Environmental Protection Agency

(USEPA). 1992a. Draft Ground Water

Disinfection Rule Available for Public

Comment. Notice of Availability and

Review. 57 FR 33960, July 31, 1992.

U.S. Environmental Protection Agency

(USEPA). 1992b. Phase V Rule. 57 FR

31821.

U.S. Environmental Protection Agency

(USEPA).1991a. Guidance Manual for

Compliance with the Filtration and

Disinfection Requirements for Public Water

Systems Using Surface Water Sources.

Contract No. 68–01–6989.

U.S. Environmental Protection Agency

(USEPA). 1991b. Wellhead Protection

Strategies for Confined-Aquifer Settings.

Environmental Protection Agency,

Washington DC.

U.S. Environmental Protection Agency

(USEPA). 1991c. Delineation of Wellhead

Protection Areas in Fractured Rocks.

Transferability of Results. P. 71–84.

Environmental Protection Agency,

Washington DC.

U.S. Environmental Protection Agency

(USEPA). 1991d. Phase II. 56 FR 30268.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30267

U.S. Environmental Protection Agency

(USEPA). 1990a. Drinking Water;

Announcement of Public Meeting to

Discuss the Preliminary Concept Paper for

the Ground Water Disinfection

Requirements. Meeting Notice. 55 FR

21093, May 22, 1990.

U.S. Environmental Protection Agency

(USEPA). 1990b. Surface Water Treatment

Rule Guidance Manual. Environmental

Protection Agency, Washington DC.

U.S. Environmental Protection Agency

(USEPA). 1989a. Office of Water, Total

Coliform Rule; Final Rule. 54 FR 27544,

June 29, 1989.

U.S. Environmental Protection Agency

(USEPA). 1989b. Drinking Water; National

Primary Drinking Water Regulations:

Disinfection; Turbidity, Giardia lamblia,

Viruses, Legionella, and Heterotrophic

Bacteria; Final Rule, 54 FR 27486, June 29,

1989.

U.S. Environmental Protection Agency

(USEPA). 1989c. Office of Water, CrossConnection Control Manual. (Washington,

DC: U.S. Government Printing Office,

Publication No. EPA 570/9–89–007, 1989).

U.S. EPA. 1985a. Drinking Water Criteria

Document for Viruses. ECAO–CIN–451,

June, 1985.

U.S. EPA. 1985b. Drinking Water Criteria

Document for Legionella. EPA–60/X–85–

051, March 1985.

U.S. EPA. 1984. Drinking Water Criteria

Document of Heterotrophic Bacteria., Draft

5, May 25, 1984.

U.S. General Accounting Office (USGAO).

Drinking Water Key Quality Assurance

Program is Flawed and Underfunded,

GAO/RCED–93–97. April 1993.

USGS 1984: Davies, W.E., J.H. Simpson, G.C.

Ohlmacher, W.S. Kirk, and E.G. Newton.

Engineering Aspects of Karst. In National

Atlas of the United States of America. U.S.

Geological Survey. Map #38077–AW–NA–

07M–00.

Vaughn, J.M. 1996. ‘‘Sample Analyses.’’ in

Attachment, unpublished letter on the

analysis of alluvial wells in Missouri by

Jerry Lane, Missouri Department of Natural

Resources, Rolla, MO, November 7, 1996.

Vaughn, J.M., Y.S. Chein, J.F. Novotny and D.

Strout. 1990. Effects of Ozone Treatment

on the Infectivity of Hepatitis A Virus. Can.

Journ. Of Microbiol. 36(8):557–560.

Velazquez, F. R., D. O. Matson, J. J. Calva, M.

Lourdes Guerrero, Ardythe L. Morrow,

Shelly Carter-Campbell, Roger I. Glass,

Mary K. Estes, Larry K. Pickering, and

Guillermo M. Ruiz-Palacios. 1996.

Rotavirus infection in infants as protection

against subsequent infections.@ N. Engl. J.

Med. 335:1022–1028.

Ward, R.L. 1986. Human Rotavirus Studies in

Volunteers: Determinations of infectious

Dose and Serological Response to

Infection. J. Inf. Dis. 154(5):871.

WHO. 1996. Microbiological Criteria. In:

Guidelines for Drinking Water Quality:

Health Criteria and Other Supporting

Information. Vol. 2. World Health

Organization. Geneva.

Wiedenmann, A., B. Fischer, C. Straub, H.

Wang, B. Flehmig and D. Schoenen. 1993.

Disinfection of Hepatitis A Virus and MS2

Coliphage in Water by Ultraviolet

Irradiation: Comparison of UVSusceptibility. Water Sci. Tech. Vol. 27,

No.3–4, pp. 335–338.

Wenman, W. M., D. Hinde, S. Felthan and M.

Gurwith. 1979. Rotavirus in adults. Results

of a prospective study. @ 1979. N. Engl. J.

Med. 301 (6): 303–306.

Wilson B.R., P.F. Roessler, E. VanDellen, M.

Abbaszadegan, and C.P. Gerba. 1992.

Coliphage MS2 as a UV Water Disinfection

Efficacy Test Surrogate for Bacterial and

Viral Pathogens. Proceedings of the Water

Quality Technology Conference. American

Water Works Association. Toronto Ontario,

Canada. May.

Yanko, W.A., J.L Jackson, F.P. Williams, A.S.

Walker, and M.S. Castillo. 1999. ‘‘An

unexpected temporal pattern of coliphage

isolation in ground waters sampled from

wells at varied distance from reclaimed

water recharge sites.’’ Wat. Res.. Vol. 33,

pp 53–64.

Yates, M.V. 1999. Viruses and Indicators in

Ground water, Results of Repeated

Monitoring. Unpublished report, February

23, 1999.

List of Subjects in 40 CFR Parts 141 and

142

Environmental protection, Indianslands, Intergovernmental relations,

Radiation protection, Reporting and

recordkeeping requirements, Water.

Dated: April 17, 2000.

Carol M. Browner,

Administrator.

For the reasons set forth in the

preamble, title 40 chapter I of the Code

of Federal Regulations is proposed to be

amended as follows:

PART 141—NATIONAL PRIMARY

DRINKING WATER REGULATIONS

1. The authority citation for part 141

continues to read as follows:

Authority: 42 U.S.C. 300f, 300g–1, 300g–2,

300g–3, 300g–4, 300g–5, 300g–6, 300j–4,

300j–9, and 300j–11.

2. Section 141.21 is amended by

adding paragraph (d)(3) to read as

follows:

§ 141.21 Coliform sampling.

* * * * *

(d) * * *

(3) Sanitary surveys conducted by the

State under § 142.16(k)(2) of this

chapter, at the frequencies specified,

may be used to meet the sanitary

surveys requirements of this section.

* * * * *

3. Section 141.154 is amended by

adding paragraph (f) to read as follows:

§ 141.154 Required additional health

information.

* * * * *

(f) Ground water systems that detect

E. coli, enterococci or coliphage in the

source water as required by § 141.403

must include the health effects language

prescribed by Appendix B of subpart Q

of this part.

* * * * *

4. Section 141.202 as added by the

final rule published on May 4, 2000 is

amended by adding entry (9) in

numerical order to the table in

paragraph (a) 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

*****

(9) Violation of the treatment technique for

the Ground Water Rule (as specified in

§ 141.405(a) through (c) or when E. coli,

enterococci, or coliphage are present as

specified in § 141.403) or when the

water system fails to test for E. coli,

enterococci, coliphage (as specified in

§ 141.403).

*****

5. Appendix A of subpart Q as added

by the final rule published on May 4,

2000 is amended by adding entry 8.

under I.A. ‘‘Microbiological

Contaminants’’ and by adding entry G.

under IV. ‘‘Other Situations Requiring

Public Notification’’ to read as follows:

30268 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

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

(INCLUDING D/DBP AND IESWTR VIOLATIONS)

Contaminant

MCL/MRDL/TT violations 2 Monitoring and testing

procedure violations

Tier of public notice

required

Citation Tier of public notice

required

Citation

*******

A. Microbiological Contaminants

*******

8. GWR TT violations ....................................................................................................... 1 141.405 N/A N/A

*******

IV. Other Situations Requiring Public Notification

*******

G. Fecal indicators for GWR: E. coli, enterococci, coliphage ......................................... 1 141.403 1 141.403

Appendix A Endnotes

1Violations and other situations not listed in this table (e.g., reporting violations and 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.

* * * * *

6. Appendix B to subpart Q as added by the final rule published on May 4, 2000 is amended by adding a new

entry 1c in numerical order un A. ‘‘Microbiological Contaminants’’ and by redisinating entries C. through H. as D.

through I. and adding a new C. in alphabetical order to read as follows:

APPENDIX B OF SUBPART Q OF PART 141.—STANDARD HEALTH EFFECTS LANGUAGE FOR PUBLIC NOTIFICATION

Contaminant MCLG 1mg/L MCL 2

mg/L

*******

A. Microbiological Contaminants

*******

1c. Fecal indicators (GWR):

i. E. coli ......................................

ii. enterococci .....................

iii. coliphage .......................

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

None

None

None ............ Fecal indicators are bacteria or viruses whose presence indicates that

the water may be contaminated with human or animal wastes. Microbes in these wastes can cause short-term effects, such as diarrhea,

cramps, nausea, headaches, or other symptoms. They may pose a

special health risk for infants, young children, some of the elderly, and

people with severely compromised immune systems

*******

C. Ground Water Rule (GWR) TT

violations.

None ............ TT ................ Inadequately treated or inadequately protected water may contain disease-causing organisms. These organisms include bacteria and viruses which can cause symptoms such as diarrhea, nausea, cramps,

and associated headaches.

*******

Appendix B Endnotes

1. MCLG—Maximum contaminant level goal.

2. MCL—Maximum contaminant level.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30269

* * * * *

7. Appendix C to subpart Q as added

in the final rule published on May 4,

2000 amended by adding the following

abbreviation in alphabetical order to

read as follow:

Appendix C to Subpart Q of Part 141—List

of Acronyms Used in Public Notification

Regulation

* * * * *

GWR Ground Water Rule

* * * * *

9. A new subpart S is proposed to be

added to read as follows:

Subpart S—Ground Water Rule

Sec.

141.400 General requirements and

applicability.

141.401 Sanitary survey information

request.

141.402 Hydrogeologic sensitivity

assessment information request.

141.403 Microbial monitoring of source

water and analytical methods.

141.404 Treatment technique requirements.

141.405 Treatment technique violations.

141.406 Reporting and record keeping.

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. All public water

systems that are served solely by ground

water. The requirements in this subpart

also apply to subpart H systems that

distribute ground water that is not

treated to 4-log inactivation or removal

of viruses before entry into the

distribution system. Systems supplied

by ground water under the direct

influence of surface water are regulated

under subparts H and P of this part, not

under this subpart. For the purposes of

this subpart, ‘‘ground water system’’ is

defined as any public water system

meeting this applicability statement.

(c) General requirements. These

regulations in this subpart establish

requirements related to sanitary surveys,

hydrogeologic sensitivity assessments,

and source water microbial monitoring

performed at ground water systems as

defined by paragraph (b) of this section.

The regulations in this subpart also

establish treatment technique

requirements for these ground water

systems which have fecally

contaminated source waters, as

demonstrated under § 141.403, or

significant deficiencies as identified in

a sanitary survey conducted by a State

under either § 142.16(k)(2) of this

chapter or by EPA under SDWA section

1445. Ground water systems with

fecally contaminated source water or

significant deficiencies must meet one

or more of the following treatment

technique requirements: eliminate the

source of contamination, correct the

significant deficiency, provide an

alternate source water, or provide a

treatment which reliably achieves at

least 99.99 percent (4-log) inactivation

or removal of viruses before or at the

first customer. Ground water systems

which provide 4-log inactivation or

removal of viruses will be required to

conduct compliance monitoring to

demonstrate treatment effectiveness.

(d) Compliance dates. Ground water

systems must comply with the

requirements of this subpart beginning

[DATE 3 YEARS AFTER PUBLICATION

OF THE FINAL RULE IN THE FEDERAL

REGISTER.

§ 141.401 Sanitary survey information

request.

Ground water systems must provide

the State at its request, any pertinent

existing information that would allow

the State to perform a sanitary survey as

described in § 142.16(k)(2) of this

chapter. For the purposes of this

subpart, ‘‘sanitary survey,’’ as

conducted by the State, includes but is

not limited to an onsite review of the

water source (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.

§ 141.402 Hydrogeologic sensitivity

assessment information request.

Ground water systems must provide

the State at its request, any pertinent

existing information that would allow

the State to perform a hydrogeologic

sensitivity assessment as described in

§ 142.16(k)(3) of this chapter.

§ 141.403 Microbial monitoring of source

water and analytical methods.

(a) Routine monitoring. Any ground

water system that draws water from a

hydrogeologically sensitive drinking

water source, as determined under

§ 142.16(k)(3) of this chapter, and that

does not provide 4-log inactivation or

removal of viruses, must collect a source

water sample each month that it

provides water to the public and test the

sample for the fecal indicator specified

by the State under paragraph (d) of this

section. Ground water systems must

begin monitoring the month after being

notified of the hydrogeologic sensitivity

assessment.

(b) Triggered monitoring. Any ground

water system that does not provide 4-log

inactivation or removal of viruses, and

is notified of a total coliform-positive

sample under § 141.21, must collect,

within 24 hours of notification, at least

one source water sample and have the

sample tested for the fecal indicator

specified by the State under paragraph

(d) of this section. This requirement is

in addition to all monitoring and testing

requirements under § 141.21.

(c) Systems with disinfection. Ground

water systems currently providing 4-log

inactivation or removal of viruses must

notify the State of such and must

conduct compliance monitoring in

accordance with § 141.404(c). This

notification must be made by the

effective date of the rule. All new

systems must notify the State of the

level of virus inactivation they are

achieving prior to serving their first

customer.

(d) Analytical methods. Source water

samples must be tested for one of the

following fecal indicators: E. coli,

coliphage, or enterococci, as specified

by the State. For whichever fecal

indicator is specified by the State, the

ground water system must use one of

the analytical methods listed in the

following table:

ANALYTICAL METHODS FOR SOURCE

WATER MONITORING

Indicator Method1

E. coli ............. Colilert Test (Method

9223B)2, 3

Colisure Test (Method

9223B)2, 3

Membrane Filter Method

with MI Agar4, 5

m-ColiBlue24 Test 4, 6

E*Colite Test 4, 7

May also use the EC-MUG

(Method 9212F) 2 and NAMUG (Method 9222G) 2 E.

coli confirmation step

§ 141.21(f)(6) after the

EPA approved Total Coliform methods in

§ 141.21(f)(3)

enterococci ..... Multiple-Tube Tech. (Method

9230B) 1

Membrane Filter Tech.

(Method 9230C) 1, 8

Enterolert 3

Coliphage ....... EPA Method 1601: TwoStep Enrichment Presence-Absence Procedure9

EPA Method 1602: Single

Agar layer Procedure9

1The time from sample collection to initiation of analysis may not exceed 30 hours.

Systems are encouraged but not required to

hold samples below 10°C during transit. 2 Methods are approved and described in

Standard Methods for the Examination of

Water and Wastewater (20th edition).

30270 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

3 Medium available through IDEXX Laboratories, Inc., One IDEXX Drive, Westbrook,

Maine 04092. 4EPA approved drinking water methods.

5Brenner, K.P., C.C. Rankin, Y.R. Roybal,

G.N. Stelma, P.V. Scarpino, and A.P. Dufour.

1993. New medium for the simultaneous detection of total coliforms and Escherichia coli

in water. Appl. Environ. Microbiol. 59:3534–

3544. 6 Hach Company, 100 Dayton Ave., Ames,

IA 50010. 7 Charm Sciences, Inc., 36 Franklin St.,

Malden, MA 02148–4120. 8Proposed for EPA approval, EPA Method

1600: MF Test Method for enterococci in

Water (EPA–821–R–97–004 (May 1997)) is an

approved variation of Standard Method

9230C. 9Proposed for EPA approval are EPA Methods 1601 and 1602, which are available from

the EPA’s Water Resources Center, Mail

code: RC–4100, 1200 Pennsylvania Ave. NW,

Washington, DC 20460.

(e) Notification of State. If any source

water sample is positive for E. coli,

coliphage, or enterococci, the ground

water system shall notify the State as

soon as possible after the system is

notified of the test result, but in no case

later than the end of the next business

day, and take corrective action in

accordance with § 141.404(b).

(f) Resampling after invalidation.

Where the State invalidates a positive

source water sample under paragraph (i)

of this section, the ground water system

must collect another source water

sample and have it analyzed for the

same fecal indicator within 24 hours of

being notified of the invalidation.

(g) Triggered monitoring waiver. The

State may waive triggered source water

monitoring as described in § 141.403(b)

due to a total coliform-positive sample,

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

determines that the total coliform

positive sample is associated solely with

a demonstrated distribution system

problem. In such a case, a State official

must document the decision, including

the rationale for the decision, in writing,

and sign the document.

(h) Reduce frequency for routine

monitoring. The State may reduce

routine source water monitoring to

quarterly if a hydrogeologically

sensitive ground water system detects

no fecal indicator-positive samples in

the most recent twelve monthly

samples, during the months the ground

water system is in operation. Moreover,

the State may, after those twelve

monthly samples, waive source water

monitoring altogether for a ground water

system if the State determines, and

documents the determination in writing,

that fecal contamination of the well(s)

has not been identified and is highly

unlikely based on the sampling history,

land use pattern, disposal practices in

the recharge area, and proximity of

septic tanks and other fecal

contamination sources. If the State

determines that circumstances have

changed, the State has the discretion to

reinstate routine monthly monitoring. In

any case, a State official must document

the determination in writing, including

the rationale for the determination,

addressing each factor noted in this

paragraph and sign the document.

(i) Invalidation of samples. A source

water sample may be determined by the

State to be invalid only if the laboratory

establishes that improper sample

analysis occurred or the State has

substantial grounds to believe that a

sample result is due to circumstances

that do not reflect source water quality.

In such a case, a State official must

document the decision, including the

rationale for the decision, in writing,

and sign the document. The written

documentation must state the specific

cause of the invalid sample and what

action the ground water system or

laboratory has taken or will take to

correct this problem. A positive sample

may not be invalidated by the State

solely on the grounds that repeat

samples are negative.

(j) Repeat sampling. A ground water

system may apply to the State, and the

State may consider, on a one-time basis,

to waive compliance with the treatment

technique requirements in § 141.404(b),

after a single fecal indicator-positive

from a routine source water sample as

required in § 141.403(a), if all the

following conditions are met:

(1) The ground water system collects

five repeat source water samples within

24 hours after being notified of a source

water fecal indicator positive result;

(2) The ground water system has the

samples analyzed for the same fecal

indicator as the original sample;

(3) All the repeat samples are fecal

indicator negative; and

(4) All required source water samples

(routine and triggered) during the past

five years were fecal indicator-negative.

§ 141.404 Treatment technique

requirements.

(a) Ground water systems with

significant deficiencies. As soon as

possible, but no later than 90 days after

receiving written notification from the

State of a significant deficiency, a

ground water system must do one or

more of the following: eliminate the

source of contamination, correct the

significant deficiency, provide an

alternate source water, or provide a

treatment which reliably achieves at

least 99.99 percent (4-log) inactivation

or removal of viruses before or at the

first customer. Ground water systems

which provide 4-log inactivation or

removal of viruses will be required to

conduct compliance monitoring to

demonstrate treatment effectiveness.

The ground water system must consult

with the State to determine which of the

approaches, or combination of

approaches, are appropriate for meeting

the treatment technique requirement.

Ground water systems unable to address

the significant deficiencies in 90 days,

must develop a specific plan and

schedule for meeting this treatment

technique requirement, submit them to

the State, and receive State approval

before the end of the same 90-day

period. For the purposes of this

paragraph, a ‘‘significant deficiency’’

includes: 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

potential for causing the introduction of

contamination into the water delivered

to consumers.

(b) Ground water systems with source

water contamination. As soon as

possible, but no later than 90 days after

the ground water system is notified that

a source water sample is positive for a

fecal indicator, the ground water system

must do one or more of the following:

eliminate the source of contamination,

correct the significant deficiency,

provide an alternate source water, or

provide a treatment which reliably

achieves at least 99.99 percent (4-log)

inactivation or removal of viruses before

or at the first customer. Ground water

systems which provide 4-log

inactivation or removal of viruses will

be required to conduct compliance

monitoring to demonstrate treatment

effectiveness. The ground water system

must consult with the State to

determine which of the approaches, or

combination of approaches, are

appropriate for meeting the treatment

technique requirement. Ground water

systems unable to address the

contamination problem in 90 days must

develop a specific plan and schedule for

meeting this treatment technique

requirement, submit them to the State,

and receive State approval before the

end of the same 90-day period specified

previously. This requirement also

applies to ground water systems for

which States have waived source water

monitoring under § 141.403(h) and have

a fecal coliform-or E. coli-positive while

testing under § 141.21.

(c) Compliance monitoring. Ground

water systems that provide 4-log

inactivation or removal of viruses, or

begin treatment pursuant to paragraph

(a) or (b) of this section, must monitor

the effectiveness and reliability of

treatment as follows:

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30271

(1) Chemical disinfection. (i) Ground

water systems serving 3,300 or more

people must continuously monitor and

maintain the State-determined residual

disinfectant concentration every day the

ground water system serves water to the

public.

(ii) Ground water systems serving

fewer than 3,300 people must monitor

and maintain the State-determined

residual disinfectant concentration

every day the ground water system

serves water to the public. The ground

water system will monitor by taking a

daily grab sample during the hour of

peak flow or another time specified by

the State. If any daily grab sample

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.

(2) UV disinfection. Ground water

systems using UV disinfection must

continuously monitor for and maintain

the State-prescribed UV irradiance level

every day the ground water system

serves water to the public.

(3) Membrane filtration. Ground water

systems that use membrane filtration as

a treatment technology are assumed to

be achieving at least 4-log removal of

viruses when the membrane process is

operated in accordance with Statespecified compliance criteria developed

under § 142.16(k)(5)(ii) of this chapter,

or as provided by EPA, and the integrity

of the membrane is intact. Applicable

membrane filtration technologies are

reverse osmosis (RO), nanofiltration

(NF), and any membrane filters

developed in the future that have

absolute MWCOs (molecular weight cutoffs) that can achieve 4-log virus

removal.

(d) Discontinuing treatment. Ground

water systems may discontinue 4-log

inactivation or removal of viruses if the

State determines based on an on-site

investigation, and documents that

determination in writing, that the need

for 4-log inactivation or removal of

viruses no longer exists. Ground water

systems are subject to triggered

monitoring in accordance with

§ 141.403(b).

§ 141.405 Treatment technique violations.

The following are treatment technique

violations which require the ground

water system to give public notification

pursuant to Appendix A of subpart Q of

this part, using the language specified in

Appendix B of subpart Q of this part.

(a) A ground water system with a

significant deficiency identified by a

State (as defined in § 141.401) which

does not correct the deficiency, provide

an alternative source, or provide 4-log

inactivation or removal of viruses

within 90 days, or does not obtain,

within the same 90 days, State approval

of a plan and schedule for meeting the

treatment technique requirement in

§ 141.404, is in violation of the

treatment technique.

(b) A ground water system that detects

fecal contamination in the source water

and does not eliminate the source of

contamination, correct the significant

deficiency, provide an alternate source

water, or provide a treatment which

reliably achieves at least 99.99 percent

(4-log) inactivation or removal of viruses

before or at the first customer within 90

days, or does not obtain within the same

90 days, State approval of a plan for

meeting this treatment technique

requirement, is in violation of the

treatment technique unless the detected

sample is invalidated under § 141.403(i)

or the treatment technique is waived

under § 141.403(j). Ground water

systems which provide 4-log

inactivation or removal of viruses will

be required to conduct compliance

monitoring to demonstrate treatment

effectiveness.

(c) A ground water system which fails

to address either a significant deficiency

as provided in paragraph (a) of this

section or fecal contamination as

provided in paragraph (b) of this section

according to the State-approved plan, or

by the State-approved deadline, is in

violation of the treatment technique. In

addition, a ground water system which

fails to maintain 4-log inactivation or

removal of viruses, is in violation of the

treatment technique, if the failure is not

corrected within four hours.

§ 141.406 Reporting and record keeping.

(a) Reporting. In addition to the

requirements of § 141.31, ground water

systems regulated under this subpart

must provide the following information

to the State:

(1) Ground water systems conducting

continuous monitoring must notify the

State any time the residual disinfectant

concentration (irradiance in the case of

UV) falls below the State-determined

value and is not restored within 4 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) Ground water systems taking daily

grab samples must notify the State any

time the residual disinfectant

concentration falls below the Statedetermined value and is not restored

within 4 hours, as determined by

follow-up samples. 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.

(3) Ground water systems using

membrane filtration must notify the

State any time the membrane is not

operated in accordance with standard

operation and maintenance procedures

for more than 4 hours, or any failure of

the membrane integrity occurs and is

not restored within 4 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.

These operation and maintenance

procedures will be provided by EPA or

developed by the State under

§ 142.16(k)(5)(ii) of this chapter.

(4) If any source water sample is

positive for E. coli, coliphage, or

enterococci, the ground water system

shall notify the State as soon as

possible, but in no case later than the

end of the next business day, and take

corrective action in accordance with

§ 141.404(b).

(5) If any ground water system has

reason to believe that a disease outbreak

is potentially attributable to their

drinking water, it must report the

outbreak to the State as soon as possible,

but in no case later than the end of the

next business day.

(6) After implementation of any

required treatment techniques, a ground

water system must provide as soon as

possible, but in no case later than the

end of the next business day, written

confirmation to the State that the

corrective action required by

§ 141.404(a) and (b) were met.

(7) Notification that the ground water

system is currently providing 4-log

inactivation or removal of viruses.

(b) Record keeping. In addition to the

requirements of § 141.33, ground water

systems regulated under this subpart

must maintain the following

information in their records:

(1) Documentation showing the fecal

indicator the State is requiring the

ground water system to use.

(2) Documentation showing

consultation with the State on

approaches for addressing significant

deficiencies including alternative plans

and schedules and State approval of

such plans and schedules.

(3) Documentation showing

consultation with the State on

approaches for addressing source water

fecal contamination including

alternative plans and schedules and

State approval of such plans and

schedules.

30272 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

PART 142—NATIONAL PRIMARY

DRINKING WATER REGULATIONS

IMPLEMENTATION

1. 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, 300j9, and 300j-11.

2. 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

determinations, including all supporting

information and an explanation of the

technical basis for each decision, made

under the following provisions of 40

CFR part 141, subpart S for the Ground

Water Rule.

(i) Section 142.16(k)(3)—State

determinations of source water

hydrogeologic sensitivity, and

determinations of the presence of

hydrogeologic barriers.

(ii) Section 141.404(c) ‘‘ notification

to individual ground water systems of

the proper residual disinfection

concentrations (when using chemical

disinfection), irradiance level (when

using UV), or EPA-specified or State

specified compliance criteria (when

using membrane filtration) needed to

achieve 4-log inactivation of viruses.

(iii) Section 141.403(g)—waivers of

triggered monitoring.

(iv) Section 141.403(h)—reductions of

monitoring.

(v) Section 141.403(i)—invalidation of

positive source water samples.

(vi) Section 141.403(j)—waiver of

compliance with treatment technique

requirements.

(vii) Section 141.404(a)—notifications

of significant deficiencies, consultation

with the ground water systems,

including written confirmation of

corrections of significant deficiencies by

ground water systems and written

records of State site visits and approved

plans and schedules.

(ix) Section 141.404(d)—

determinations of when a ground water

system can discontinue 4-log

inactivation or removal of viruses.

* * * * *

3. Section 142.15 is amended by

adding paragraphs (c)(6) through (10) to

read as follows:

§ 142.15 Reports by States.

* * * * *

(c) * * *

(6) Sanitary surveys. An annual list of

ground water systems that have had a

sanitary survey completed during the

previous year and an annual evaluation

of the State’s program for conducting

sanitary surveys under § 142.16(k)(2).

(7) Hydrogeologic sensitivity

assessments. An annual list of ground

water systems that have had a

sensitivity assessment completed during

the previous year, a list of those ground

water systems which are sensitive, a list

of ground water systems which are

sensitive, but for which the State has

determined that a hydrogeologic barrier

exists at the site sufficient for protecting

public health, and an annual evaluation

of the State’s program for conducting

hydrogeologic sensitivity assessments

under § 142.16 (k)(3).

(8) Source water microbial

monitoring. An annual list of ground

water systems that have had to test the

source water as described under

§ 141.403 of this chapter, a list of

determinations of invalid samples, and

a list of waivers of source water

monitoring provided by the State.

(9) Treatment technique compliance.

An annual list of ground water systems

that have had to meet treatment

technique requirements for significant

deficiencies or contaminated source

water under § 141.404 of this chapter, a

list of determinations to discontinue 4-

log inactivation or removal of viruses,

and a list of ground water systems that

violated the treatment technique

requirements.

(10) Ground water systems providing

4-log inactivation or removal of viruses.

An annual list of ground water systems

that have notified the State that they are

currently providing 4-log inactivation or

removal of viruses.

* * * * *

4. Section 142.16 is amended by

adding and reserving paragraphs (i) and

(j) and adding paragraph (k) to read as

follows:

§ 142.16 Special primacy requirements.

* * * * *

(i) [Reserved]

(j) [Reserved]

(k) 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 a description of how the

State will accomplish the following

program requirements:

(1) Enforceable requirements. (i)

States must have the appropriate rules

or other authority to ensure that ground

water systems take the steps necessary

to address, in accordance with

§ 141.404(a) of this chapter, any

significant deficiencies identified in the

written notification provided by the

State as required under paragraph (k)(2)

of this section.

(ii) States must have appropriate rules

or other authority to ensure that ground

water systems respond in writing in

regard to the resolution of significant

deficiencies identified in the written

notification provided by the State

following identification of the

significant deficiencies.

(iii) States must have the appropriate

rules or other authority to ensure that

ground water systems take the steps

necessary to address, in accordance

with § 141.404(b) of this chapter, any

fecal contamination identified during

routine or triggered monitoring in

accordance with § 141.403(a) and (b) of

this chapter.

(2) Sanitary survey. In its primacy

application the State must describe how

it, or an authorized agent, will

implement a sanitary survey program

that meets the requirements of this

section.

(i) For the purposes of this paragraph

(k)(2), ‘‘sanitary survey’’ includes, but is

not limited to, an onsite review of the

water source (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.

(ii) The State, or an authorized agent,

must conduct sanitary surveys for all

ground water systems. The sanitary

survey must address the eight sanitary

survey components listed in paragraphs

(k)(2)(ii)(A) through (H) of this section

no less frequently than every three years

for community systems and no less

frequently than every five years for

noncommunity systems. The first

sanitary survey for community water

systems must be completed by [DATE 6

YEARS AFTER DATE OF

PUBLICATION OF THE FINAL RULE

IN THE FEDERAL REGISTER] and for

noncommunity water systems, must be

completed by [DATE 8 YEARS AFTER

DATE OF PUBLICATION OF THE

FINAL RULE IN THE FEDERAL

REGISTER].

(A) Source.

(B) Treatment.

(C) Distribution system.

(D) Finished water storage.

(E) Pumps, pump facilities, and

controls.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules 30273

(F) Monitoring and reporting and data

verification.

(G) System management and

operation.

(H) Operator compliance with State

requirements.

(iii) After the initial sanitary survey

for ground water systems in accordance

with § 142.16(k)(2)(ii), the State may

reduce the frequency of sanitary surveys

for community water systems to no less

frequently than every five years, if the

ground water system either treats to 4-

log inactivation or removal of viruses or

has an outstanding performance record

documented in previous inspections

and has no history of total coliform MCL

or monitoring violations under § 141.21

of this chapter as determined by the

State, since the last sanitary survey

under the current ownership. In its

primacy application, the State must

describe how it will decide whether a

community water system has

outstanding performance and is thus

eligible for sanitary surveys at a reduced

frequency.

(iv) States may complete components

of a sanitary survey as part of a staged

or phased State review process within

the established frequency specified in

paragraph (k)(2)(ii) or (iii) of this

section. In its primacy application, a

State which plan to complete the

sanitary survey in a staged or phased

State review process must indicate

which approach it will take and provide

the rationale for the specified time

frames for sanitary surveys conducted

on a staged or phased approach basis.

(v) Sanitary surveys that meet the

requirements of this subpart, including

the requisite eight components

identified in paragraph (k)(2)(ii) of this

section and conducted at the specified

frequency, are considered to meet the

requirements for sanitary surveys under

the Total Coliform Rule (TCR) as

described in § 141.21 of this chapter.

Note however, compliance only with

the TCR sanitary survey requirements

may not be adequate to meet the revised

scope and frequency sanitary survey

requirement of this subpart.

(vi) States must provide ground water

systems with written notification

identifying and describing any

significant deficiencies identified at the

ground water system no later than 30

days after identifying the significant

deficiencies. States will provide ground

water systems with written notification

by certified mail or on-site from the

sanitary survey inspector. In its primacy

application, the State must indicate how

it will define what constitutes a

significant deficiency for purposes of

this subpart. For the purposes of this

paragraph, a ‘‘significant deficiency’’

includes: 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

potential for causing the introduction of

contamination into the water delivered

to consumers.

(vii) In its primacy application, the

State must describe how it will consult

with the ground water system regarding

the treatment technique requirements

specified in § 141.404 and criteria for

determining when a ground water

system has met the 4-log inactivation or

removal of viruses of this chapter.

(viii) States must confirm that the

deficiency has been addressed, either

through written confirmation from

ground water systems or a site visit by

the State, within 30 days after the

ground water system has met the

treatment technique requirements under

§ 141.404(a) of this chapter.

(ix) In its primacy application, the

State must specify if and how it will

integrate Source Water Assessment and

Protection Program (SWAPP)

susceptibility determinations into the

sanitary survey and the definition of

significant deficiency.

(3) Hydrogeologic sensitivity

assessments. (i) For the purposes of this

paragraph (k)(3), ‘‘hydrogeologic

sensitivity assessment’’ means the

methodology used by the State to

identify whether ground water systems

are obtaining water from karst, gravel, or

fractured bedrock aquifers. A State may

add additional hydrogeologic sensitive

settings, e.g., volcanic aquifers. A well

obtaining water from a karst, gravel or

fractured bedrock aquifer is sensitive to

fecal contamination unless the well is

protected by a hydrogeologic barrier. A

‘‘hydrogeologic barrier’’ consists of

physical, chemical and biological

factors that, singularly or in

combination, prevent the movement of

viable pathogens from a contaminant

source to a ground water system well.

(ii) The State, or an authorized agent,

must conduct a one-time hydrogeologic

sensitivity assessment for all existing

ground water systems not providing 4-

log inactivation or removal of viruses by

[DATE SIX YEARS AFTER DATE OF

PUBLICATION OF THE FINAL RULE

IN THE FEDERAL REGISTER] for

community water systems and by

[DATE EIGHT YEARS AFTER DATE OF

PUBLICATION OF THE FINAL RULE

IN THE FEDERAL REGISTER] for noncommunity water systems. The State, or

an authorized agent, must conduct a

hydrogeologic sensitivity assessment for

new systems prior to their serving water

to the public.

(iii) In its primacy application, a State

must identify its approach to determine

the adequacy of a hydrogeologic barrier,

if present, as part of its effort to

determine the sensitivity of a ground

water system in a hydrogeologic

sensitivity assessment.

(4) Source water microbial

monitoring. (i) In its primacy

application, the State must identify its

approach and rationale for determining

which of the fecal indicators (E. coli,

coliphage, or enterococci) ground water

systems must use in accordance with

§ 141.403(d) of this chapter.

(ii) The State may waive triggered

source water monitoring as described in

§ 141.403(b) of this chapter due to a

total coliform-positive sample, on a

case-by-case basis, if the State

determines that the total coliform

positive sample is associated solely with

a demonstrated distribution system

problem. In such a case, a State official

must document the decision, including

the rationale for the decision, in writing,

and sign the document.

(iii) The State may reduce routine

source water monitoring to quarterly if

a hydrogeologically sensitive ground

water system detects no fecal indicatorpositive samples in the most recent

twelve consecutive monthly samples

during the months the ground water

system is in operation. Moreover, the

State may, after those twelve

consecutive monthly samples, waive

source water monitoring altogether for a

ground water system if the State

determines, in writing, that fecal

contamination of the well(s) has not

been identified and is highly unlikely,

based on the sampling history, land use

pattern, disposal practices in the

recharge area, and proximity of septic

tanks and other fecal contamination

sources. If the State determines that

circumstances have changed, the State

has the discretion to reinstate routine

monthly monitoring. In any case, a State

official must document the

determination in writing, including the

rationale for the determination, and sign

the document.

(iv) The State may determine a source

water sample to be invalid only if the

laboratory establishes that improper

sample analysis occurred or the State

has substantial grounds to believe that

a sample result is due to circumstances

that do not reflect source water quality.

In such a case, a State official must

document the decision, including the

rationale for the decision, in writing,

and sign the document. The written

documentation must state the specific

cause of the invalid sample and what

action the ground water system or

laboratory has taken or must take to

30274 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Proposed Rules

correct this problem. A positive sample

may not be invalidated by the State

solely on the grounds that repeat

samples are negative, though this could

be considered along with other evidence

that the original sample result does not

reflect source water quality.

(v) A ground water system may apply

to the State, and the State may consider,

on a one-time basis, to waive

compliance with the treatment

technique requirements in § 141.404(a)

of this chapter, after a single fecal

indicator-positive from a routine source

water sample as required in § 141.403(a)

of this chapter, if all the following

conditions are met:

(A) The ground water system collects

five repeat source water samples within

24 hours after being notified of a source

water fecal positive result;

(B) The ground water system has the

samples analyzed for the same fecal

indicator as the original sample;

(C) All the repeat samples are fecal

indicator negative; and

(D) All previous source water samples

(routine and triggered) during the past 5

years were fecal indicator-negative.

(5) Treatment technique requirements.

(i) In its primacy application, the State

must describe how it must provide

every ground water system treating to 4-

log inactivation or removal the

disinfectant concentration (or

irradiance) and contact time to achieve

4-log virus inactivation or removal. EPA

recommends that the State use

applicable EPA-developed CT tables (IT

(the product of irradiance, in mW/cm2,

multiplied by exposure time, in

seconds) in the case of UV disinfection)

to determine the concentration (or

irradiance) and contact time that it will

require ground water systems to achieve

4-log virus inactivation.

(ii) If the State intends to approve

membrane filtration for treatment it

must, in its primacy application,

describe the monitoring and compliance

requirements, including membrane

integrity testing, that it will require of

ground water systems to demonstrate

proper operation of membrane filtration

technologies.

(iii) In its primacy application, a State

must describe the approach it must use

to determine which specific treatment

technique option (correcting the

deficiency, eliminating the source of

contamination, providing an alternative

source, or providing 4-log inactivation

or removal of viruses) is appropriate for

addressing significant deficiencies or

fecally contaminated source water and

under what circumstances. In addition,

the State must describe the approach it

intends to use when consulting with

ground water systems on determining

the treatment technique options.

(iv) States must confirm that the

ground water system has addressed the

source water fecal contamination

identified under routine or triggered

monitoring in accordance with

§ 141.403(a) and (b) of this chapter,

either through written confirmation

from ground water systems or a site visit

by the State, within 30 days after the

ground water system has met the

treatment technique requirements under

§ 141.404(b) of this chapter.

[FR Doc. 00–10763 Filed 5–9–00; 8:45 am]

BILLING CODE 6560–50–P