federal register

Wednesday

December 16, 1998

Part V

Environmental

Protection Agency

40 CFR Parts 9, 141, and 142

National Primary Drinking Water

Regulations: Interim Enhanced Surface

Water Treatment; Final Rule
69478 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 9, 141, and 142

[WH–FRL–6199–9]

RIN 2040–AC91

National Primary Drinking Water

Regulations: Interim Enhanced Surface

Water Treatment

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: In this document, EPA is

finalizing the Interim Enhanced Surface

Water Treatment Rule (IESWTR). The

purposes of the IESWTR are to: Improve

control of microbial pathogens,

including specifically the protozoan

Cryptosporidium, in drinking water; and

address risk trade-offs with disinfection

byproducts. Key provisions established

in today’s final IESWTR include: A

Maximum Contaminant Level Goal

(MCLG) of zero for Cryptosporidium; 2-

log Cryptosporidium removal

requirements for systems that filter;

strengthened combined filter effluent

turbidity performance standards and

individual filter turbidity provisions;

disinfection benchmark provisions to

assure continued levels of microbial

protection while facilities take the

necessary steps to comply with new

disinfection byproduct standards;

inclusion of Cryptosporidium in the

definition of ground water under the

direct influence of surface water

(GWUDI) and in the watershed control

requirements for unfiltered public water

systems; requirements for covers on new

finished water reservoirs; and sanitary

surveys for all surface water systems

regardless of size. The IESWTR builds

upon the treatment technique

requirements of the Surface Water

Treatment Rule.

EPA believes that implementation of

the IESWTR will significantly reduce

the level of Cryptosporidium in finished

drinking water supplies through

improvements in filtration. The Agency

estimates that the likelihood of endemic

illness from Cryptosporidium will

decrease by 110,000 to 463,000 cases

annually. The Agency believes that the

rule will also reduce the likelihood of

the occurrence of outbreaks of

cryptosporidiosis by providing a larger

margin of safety against such outbreaks

for some systems. In addition, the

filtration provisions of the rule are

expected to increase the level of

protection from exposure to other

pathogens (i.e., Giardia or other

waterborne bacterial or viral pathogens).

The IESWTR applies to public water

systems that use surface water or

GWUDI and serve 10,000 or more

people. The rule also requires primacy

States to conduct sanitary surveys for all

surface water and GWUDI systems

regardless of size.

EFFECTIVE DATE: This regulation is

effective February 16, 1999. Compliance

dates for specific components of the rule

are discussed in the Supplementary

Information section.

ADDRESSES: Public comments, the

comment/response document,

applicable Federal Register notices,

other major supporting documents, and

a copy of the index to the public docket

for this rulemaking are available for

review at EPA’s Drinking Water Docket:

401 M Street, SW., Rm. EB57,

Washington, DC 20460 from 9 a.m. to 4

p.m., Monday through Friday, excluding

legal holidays. For access to docket

materials, please call (202) 260–3027 to

schedule an appointment.

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

Elizabeth Corr or Paul S. Berger, Ph.D.

(Microbiology), Office of Ground Water

and Drinking Water (MC 4607), U.S.

Environmental Protection Agency, 401

M Street SW, Washington DC 20460;

telephone (202) 260–8907 (Corr) or (202)

260–3039 (Berger). For Regional

contacts see Supplementary

Information.

SUPPLEMENTARY INFORMATION: This

regulation is effective 60 days after

publication of FR document for

purposes of the Administrative

Procedures Act and the Congressional

Review Act. Compliance dates for

specific components of the rule are

discussed below. Solely for judicial

review purposes, this final rule is

promulgated as of 1 p.m. Eastern Time

December 30, 1998 as provided in 40

CFR 23.7.

Regulated entities. Entities potentially

regulated by the IESWTR are public

water systems that use surface water or

ground water under the direct influence

of surface water and serve at least

10,000 people. (States are required to

carry out sanitary surveys for all surface

water and GWUDI systems including

those that serve less than 10,000

people.) Regulated categories and

entities include:

Category Examples of regulated entities

Industry ............................................................... Public Water Systems (PWSs) that use surface water or ground water under the direct influence of surface water and serve at least 10,000 people

State, Local, Tribal or Federal Governments ..... PWSs that use surface water or ground water under the direct influence of surface water and

serve at least 10,000 people.

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

regulated by the IESWTR. This table

lists the types of entities that EPA is

now aware could potentially be

regulated by the rule. 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 subpart H

(§ 141.70(a)—systems subject to the

Surface Water Treatment Rule) and

subpart P (§ 141.170(a)—subpart H

systems that serve 10,000 or more

people) of the final rule. If you have

questions regarding the applicability of

the IESWTR to a particular entity,

consult one of the persons listed in the

preceding FOR FURTHER INFORMATION

CONTACT section.

Regional Contacts

I. Kevin Reilly, Water Supply Section,

JFK Federal Bldg., Room 203, Boston,

MA 02203, (617) 565–3616

II. Michael Lowy, Water Supply Section,

290 Broadway, 24th Floor, New York,

NY 10007–1866, (212) 637–3830

III. Jason Gambatese, Drinking Water

Section (3WM41), 1650 Arch Street,

Philadelphia, PA 19103–2029, (215)

814–5759

IV. David Parker, Water Supply Section,

345 Courtland Street, Atlanta, GA

30365, (404) 562–9460

V. Kimberly Harris, Water Supply

Section, 77 W. Jackson Blvd., Chicago,

IL 60604, (312) 886–4239
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69479

VI. Blake L. Atkins, Drinking Water

Section, 1445 Ross Avenue, Dallas,

TX 75202, (214) 665–2297

VII. Ralph Flournoy, Drinking Water/

Ground Water Management Branch,

726 Minnesota Ave., Kansas City, KS

66101, (913) 551–7374

VIII. Bob Clement, Public Water Supply

Section (8P2–W–MS), 999 18th Street,

Suite 500, Denver, CO 80202–2466,

(303) 312–6653

IX. Bruce Macler, Water Supply Section,

75 Hawthorne Street, San Francisco,

CA 94105, (415) 744–1884

X. Wendy Marshall, Drinking Water

Unit, 1200 Sixth Avenue (OW–136),

Seattle, WA 98101, (206) 553–1890

List of Abbreviations Used in This

Document

ASCE: American Society of Civil

Engineers

ASDWA: Association of State Drinking

Water Administrators

ASTM: American Society for Testing

and Materials

AWWA: American Water Works

Association

AWWARF: American Water Works

Association Research Foundation

°C: Degrees Centigrade

CCP: Composite Correction Program

CDC: Centers for Disease Control

CFE: Combined Filter Effluent

CFR: Code of Federal Regulations

CPE: Comprehensive Performance

Evaluation

CT: The Residual Concentration of

Disinfectant (mg/L) Multiplied by the

Contact Time (in minutes)

CTA: Comprehensive Technical

Assistance

DBPs: Disinfection Byproducts

DBPR: Disinfectants/Disinfection

Byproducts Rule

ESWTR: Enhanced Surface Water

Treatment Rule

FACA: Federal Advisory Committee Act

GAC: Granular Activated Carbon

GAO: Government Accounting Office

GWUDI: Ground Water Under the Direct

Influence of Surface Water

HAA5: Haloacetic acids

(Monochloroacetic, Dichloroacetic,

Trichloroacetic, Monobromoacetic

and Dibromoacetic Acids)

HPC: Heterotropic Plate Count

hrs: Hours

ICR: Information Collection Rule

IESWTR: Interim Enhanced Surface

Water Treatment Rule

IFA: Individual Filter Assessment

Log Inactivation: Logarithm of (N0/NT)

Log: Logarithm (common, base 10)

LTESWTR: Long Term Enhanced

Surface Water Treatment Rule

LT1: Long Term 1 Enhanced Surface

Water Treatment Rule

MCL: Maximum Contaminant Level

MCLG: Maximum Contaminant Level

Goal

M–DBP: Microbial and Disinfectants/

Disinfection Byproducts

MPA: Microscopic Particulate Analysis

NODA: Notice of Data Availability

NPDWR: National Primary Drinking

Water Regulation

NT: The Concentration of Surviving

Microorganisms at Time T

NTTAA: National Technology Transfer

and Advancement Act

NTU: Nephelometric Turbidity Unit

PE: Performance Evaluation

PWS: Public Water System

Reg. Neg.: Regulatory Negotiation

RIA: Regulatory Impact Analysis

RFA: Regulatory Flexibility Act

RSD: Relative Standard Deviation

SAB: Science Advisory Board

SDWA: Safe Drinking Water Act

SWTR: Surface Water Treatment Rule

TC: Total Coliforms

TCR: Total Coliform Rule

TTHM: Total Trihalomethanes

TWG: Technical Work Group

UMRA: Unfunded Mandates Reform Act

x log removal: Reduction to 1⁄10x of

original concentration

Table of Contents

I. Background

A. Statutory Requirements and Legal

Authority

B. Regulatory History

1. Existing Regulations

—Surface Water Treatment Rule (SWTR)

—Total Coliform Rule (TCR)

—Total Trihalomethane (TTHM) Rule

—Information Collection Rule (ICR)

2. Public Health Concerns to be Addressed

3. Regulatory Negotiation Process

4. Federal Advisory Committee Process

5. Overview of 1994 Proposal and 1997

Notice of Data Availability

II. Summary of the Final Rule

III. Explanation of Today’s Action

A. MCLG for Cryptosporidium

1. Today’s Rule

2. Background and Analysis

3. Summary of Major Comments

B. Removal of Cryptosporidium by Filtration

1. Today’s Rule

2. Background and Analysis

3. Summary of Major Comments

C. Turbidity Control

1. Today’s Rule

2. Background and Analysis

3. Summary of Major Comments

D. Disinfection Benchmark for Stage 1 DBPR

MCLs

1. Today’s Rule

2. Background and Analysis

3. Summary of Major Comments

E. Definition of Ground Water Under the

Direct Influence of Surface Water

1. Today’s Rule

2. Background and Analysis

3. Summary of Major Comments

F. Inclusion of Cryptosporidium in

Watershed Control Requirements

1. Today’s Rule

2. Background and Analysis

3. Summary of Major Comments

G. Covered Finished Water Reservoirs

1. Today’s Rule

2. Background and Analysis

3. Summary of Major Comments

H. Sanitary Survey Requirements

1. Today’s Rule

2. Background and Analysis

3. Summary of Major Comments

I. Compliance Schedules

1. Today’s Rule

2. Background and Analysis

3. Summary of Major Comments

IV. State Implementation

A. Special State Primacy Requirements

B. State Recordkeeping Requirements

C. State Reporting Requirements

D. Interim Primacy

V. Economic Analysis

A. Today’s Rule

B. Overview of RIA for Proposed Rule

C. What’s Changed Since the Proposed Rule

D. Summary of Cost Analysis

E. Household Costs

F. Summary of Benefits Analysis

G. Comparison of Costs and Benefits

VI. Additional Issues Discussed in 1994

Proposal and 1997 NODA

A. Inactivation of Cryptosporidium

B. Giardia Inactivation CT values for

Profiling/Benchmarking

C. Cross Connection Control

D. Filter Backwash Recycling

E. Certification Criteria for Water Plant

Operators

VII. Other Requirements

A. Regulatory Flexibility Act

B. Paperwork Reduction Act

C. Unfunded Mandates Reform Act

D. National Technology Transfer and

Advancement Act

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

H. Executive Order 12875: Enhancing the

Intergovernmental Partnership

I. Executive Order 13084: Consultation and

Coordination With Indian Tribal

Governments

J. Consultation with the Science Advisory

Board, National Drinking Water Council,

and Secretary of Health and Human

Services

K. Likely Effect of Compliance with the

IESWTR on the Technical, Financial,

and Managerial Capacity of Public Water

Systems

L. Submission to Congress and the General

Accounting Office

VIII. References

I. Background

A. Statutory Requirements and Legal

Authority

The Safe Drinking Water Act (SDWA

or the Act), as amended in 1986,
69480 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

requires USEPA to publish a ‘‘maximum

contaminant level goal’’ (MCLG) for

each contaminant which, in the

judgement of the USEPA Administrator,

‘‘may have any adverse effect on the

health of persons and which is known

or anticipated to occur in public water

systems’’ (Section 1412(b)(3)(A)).

MCLGs are to be set at a level at which

‘‘no known or anticipated adverse effect

on the health of persons occur and

which allows an adequate margin of

safety’’ (Section 1412(b)(4)).

The Act was amended in August

1996. As a result of these Amendments,

several of these provisions were

renumbered and augmented with

additional language. Other sections

were added establishing new drinking

water requirements. These

modifications are outlined below.

The Act also requires that at the same

time USEPA publishes an MCLG, which

is a non-enforceable health goal, it also

must publish a National Primary

Drinking Water Regulation (NPDWR)

that specifies either a maximum

contaminant level (MCL) or treatment

technique (Sections 1401(l) and

1412(a)(3)). USEPA is authorized to

promulgate a NPDWR ‘‘that requires the

use of a treatment technique in lieu of

establishing a MCL,’’ if the Agency finds

that ‘‘it is not economically or

technologically feasible to ascertain the

level of the contaminant’’ EPA’s general

authority to set a maximum

contaminant level goal (MCLG) and

National Primary Drinking Water

Regulation (NPDWR) applies to

contaminants that may ‘‘have an adverse

effect on the health of persons,’’ that are

‘‘known to occur or there is a substantial

likelihood that the contaminant will

occur in public water systems with a

frequency and at levels of public health

concern,’’ and for which ‘‘in the sole

judgement of the Administrator,

regulation of such contaminant presents

a meaningful opportunity for health risk

reduction for persons served by public

water systems’’ (SDWA Section

1412(b)(1)(A)).

The amendments, also require EPA,

when proposing a NPDWR that includes

an MCL or treatment technique, to

publish and seek public comment on an

analysis of health risk reduction and

cost impacts. In addition, EPA is

required to take into consideration the

effects of contaminants upon sensitive

subpopulations (i.e. infants, children,

pregnant women, the elderly, and

individuals with a history of serious

illness), and other relevant factors.

(Section 1412 (b)(3)(C)).

The amendments established a

number of regulatory deadlines,

including schedules for a Stage 1

Disinfection Byproduct Rule (DBPR), an

Interim Enhanced Surface Water

Treatment Rule (IESWTR), a Long Term

Final Enhanced Surface Water

Treatment Rule (LTESWTR) affecting

Public Water Systems (PWSs) that serve

under 10,000 people, and a Stage 2

DBPR (Section 1412(b)(2)(C)). The Act

as amended also requires EPA to

promulgate regulations to address filter

backwash (Section 1412(b)(14)) and to

promulgate regulations specifying

criteria for requiring disinfection ‘‘as

necessary’’ for ground water systems.

Finally, as part of the 1996 SDWA

Amendments, recordkeeping

requirements were modified to apply to

every person who is subject to a

requirement of this title or who is a

grantee (Section 1445(a)(1)(A)). Such

persons are required to establish and

maintain such records, make such

reports, conduct such monitoring, and

provide such information as the

Administrator may reasonably require

by regulation.

B. Regulatory History

1. Existing Regulations

Surface Water Treatment Rule (SWTR)

Under the Surface Water Treatment

Rule (SWTR) (54 FR 27486, June 29,

1989) (EPA, 1989b), EPA set maximum

contaminant level goals of zero for

Giardia lamblia, viruses, and Legionella;

and promulgated National Primary

Drinking Water Regulations for all PWSs

using surface water sources or ground

water sources under the direct influence

of surface water. The SWTR includes

treatment technique requirements for

filtered and unfiltered systems that are

intended to protect against the adverse

health effects of exposure to Giardia

lamblia, viruses, and Legionella, as well

as many other pathogenic organisms.

Briefly, those requirements include (1)

requirements for maintenance of a

disinfectant residual in the distribution

system; (2) removal and/or inactivation

of 3 log (99.9%) for Giardia and 4 log

(99.99%) for viruses; (3) combined filter

effluent turbidity performance standard

of 5 NTU as a maximum and 0.5 NTU

at the 95th percentile monthly, based on

4-hour monitoring for treatment plants

using conventional treatment or direct

filtration (with separate standards for

other filtration technologies); and (4)

watershed protection and other

requirements for unfiltered systems.

Total Coliform Rule (TCR)

The Total Coliform Rule (TCR) (54 FR

27544, June 29, 1989) applies to all

public water systems (EPA, 1989c). This

regulation sets compliance with the

Maximum Contaminant Level (MCL) for

total coliforms (TC) as follows. For

systems that collect 40 or more samples

per month, no more than 5.0% of the

samples may be TC-positive; for those

that collect fewer than 40 samples, no

more than one sample may be TCpositive. In addition, if two consecutive

samples in the system are TC-positive,

and one is also fecal coliform or E. colipositive, then this is defined as an acute

violation of the MCL. If a system

exceeds the MCL, it must notify the

public using mandatory language

developed by the EPA. The required

monitoring frequency for a system

depends on the number of people

served and ranges from 480 samples per

month for the largest systems to once

annually for certain of the smallest

systems. All systems must have a

written plan identifying where samples

are to be collected.

If a system has a TC-positive sample,

it must test that sample for the presence

of fecal coliforms or E. coli. The system

must also collect a set of repeat samples,

and analyze for TC (and fecal coliform

or E. coli if necessary) within 24 hours

of being notified of a TC-positive

sample.

The TCR also requires an on-site

inspection (referred to as a sanitary

survey) every 5 years for each system

that collects fewer than five samples per

month. (This requirement is extended to

every10 years for non-community

systems using only protected and

disinfected ground water.)

Total Trihalomethane (TTHM) Rule

In November 1979 (44 FR 68624)

(EPA, 1979) EPA set an interim MCL for

total trihalomethanes (TTHM) of 0.10

mg/L as an annual average. Compliance

is defined on the basis of a running

annual average of quarterly averages of

all samples. The value for each sample

is the sum of the measured

concentrations of chloroform,

bromodichloromethane,

dibromochloromethane and bromoform.

The interim TTHM standard only

applies to community water systems

using surface water and/or ground water

serving at least 10,000 people that add

a disinfectant to the drinking water

during any part of the treatment process.

At their discretion, States may extend

coverage to smaller PWSs; however,

most States have not exercised this

option.

Information Collection Rule (ICR)

The Information Collection Rule (ICR)

is a monitoring and data reporting rule

that was promulgated on May 14, 1996

(61 FR 24354) (EPA, 1996b). The

purpose of the ICR is to collect

occurrence and treatment information to
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69481

help evaluate the need for possible

changes to the current SWTR and

existing microbial treatment practices,

and to help evaluate the need for future

regulation for disinfectants and

disinfection byproducts (DBPs). The ICR

will provide EPA with additional

information on the national occurrence

in drinking water of (1) chemical

byproducts that form when disinfectants

used for microbial control react with

naturally occurring compounds already

present in source water and (2) diseasecausing microorganisms, including

Cryptosporidium, Giardia, and viruses.

The ICR will also provide engineering

data on how PWSs currently control for

such contaminants. This information is

being collected because the 1992

Regulatory Negotiating (Reg. Neg.)

Committee on microbial pathogens and

disinfectants and DBPs concluded that

additional information was needed to

assess the potential health problem

created by the presence of DBPs and

pathogens in drinking water and to

assess the extent and severity of risk in

order to make sound regulatory and

public health decisions. The ICR will

also provide information to support

regulatory impact analyses for various

regulatory options, and to help develop

monitoring strategies for cost-effectively

implementing regulations.

The ICR pertains to large public water

systems serving populations of at least

100,000; a more limited set of ICR

requirements pertain to ground water

systems serving between 50,000 and

100,000 people. About 300 PWSs

operating 500 treatment plants are

involved with the extensive ICR data

collection. Under the ICR, these PWSs

monitor for water quality factors

affecting DBP formation and DBPs

within the treatment plant and in the

distribution system monthly for 18

months. In addition, PWSs must

provide operating data and a description

of their treatment plant design and

surface water systems must monitor for

bacteria, viruses, and protozoa. Finally,

a subset of PWSs must perform

treatment studies, using either granular

activated carbon (GAC) or membrane

processes, to evaluate DBP precursor

removal and control of DBPs.

Monitoring for treatment study

applicability began in September 1996.

The remaining occurrence monitoring

began in July 1997.

One initial intent of the ICR was to

collect pathogen occurrence data and

other information for use in developing

the Interim Enhanced Surface Water

Treatment Rule (IESWTR) and to

estimate national costs for various

treatment options. However, because of

delays in promulgating the ICR and

technical difficulties associated with

laboratory approval and review of

facility sampling plans, ICR monitoring

did not begin until July 1, 1997, which

was later than originally anticipated. As

a result of this delay and the new

statutory deadlines for promulgating the

Stage 1 DBPR and IESWTR in November

of 1998 (resulting from the 1996 SDWA

amendments), ICR data were not

available in time to support these rules.

In place of the ICR data, the Agency

worked with stakeholders to identify

other sources of data developed since

1994 that could be used to support the

development of the Stage 1 DBPR and

IESWTR. EPA will continue to work

with stakeholders in analyzing and

using the comprehensive ICR data and

research for developing future Enhanced

Surface Water Treatment requirements

and the Stage 2 DBPR.

2. Public Health Concerns To Be

Addressed

In 1990, EPA’s Science Advisory

Board (SAB), an independent panel of

experts established by Congress, cited

drinking water contamination as one of

the most important environmental risks

and indicated that disease-causing

microbial contaminants (i.e., bacteria,

protozoa and viruses) are probably the

greatest remaining health risk

management challenge for drinking

water suppliers (EPA/SAB, 1990).

Information on the number of

waterborne disease outbreaks from the

U.S. Centers for Disease Control and

Prevention (CDC) underscores this

concern. CDC indicates that, between

1980 and 1996, 401 waterborne disease

outbreaks were reported, with over

750,000 associated cases of disease

(Craun 1998, 1997a; Kramer et al 1996).

During this period, a number of agents

were implicated as the cause, including

protozoa, viruses and bacteria, as well

as several chemicals. Most of the cases

(but not outbreaks) were associated with

surface water, and specifically with a

single outbreak of cryptosporidiosis in

Milwaukee (over 400,000 cases)

(MacKenzie et al, 1994).

It is important to note that for a

number of reasons, the CDC reports may

substantially understate the actual

number of waterborne disease outbreaks

and cases in the U.S. First, few States

have an active outbreak surveillance

program. Second, disease outbreaks are

often not recognized in a community or,

if recognized, are not traced to the

drinking water source. Third, a large

number of people experiencing

gastrointestinal illness (predominantly

diarrhea) do not seek medical attention.

Fourth, physicians may often not have

a broad enough community-wide basis

of information to attribute

gastrointestinal illness to any specific

origin such as a drinking water source.

Finally, an unknown but probably

significant portion of waterborne

disease is endemic (i.e., not associated

with an outbreak), and thus is even

more difficult to recognize.

Waterborne disease is usually acute

(i.e., sudden onset and typically lasting

a short time in healthy people). Some

pathogens (e.g., Giardia,

Cryptosporidium) may cause extended

illness, sometimes lasting months or

longer, in otherwise healthy

individuals. Most waterborne pathogens

cause gastrointestinal illness, with

diarrhea, abdominal discomfort, nausea,

vomiting, and/or other symptoms. Other

waterborne pathogens cause, or at least

are associated with, more serious

disorders such as hepatitis, gastric

cancer, peptic ulcers, myocarditis,

swollen lymph glands, meningitis,

encephalitis, and a myriad of other

diseases.

Gastrointestinal illness may be

chronic in vulnerable populations (e.g.,

immunocompromised individuals). The

severity and duration of illness is often

greater in immunocompromised persons

than in healthy individuals and may be

fatal among this population. For

instance, a follow-up study of the 1993

Milwaukee waterborne disease outbreak

reported that at least 50

Cryptosporidium-associated deaths

occurred among the severely

immunocompromised (Hoxie et al.,

1997). Immunocompromised persons

include infants, pregnant women, the

elderly, and especially those with

severely weakened immune systems

(e.g., AIDS patients, those receiving

treatment for certain types of cancer,

organ-transplant recipients and people

on immunosuppressant drugs) (Gerba et

al., 1996).

With specific reference to

cryptosporidiosis, the disease is caused

by ingestion of environmentallyresistant Cryptosporidium oocysts,

which are readily carried by the

waterborne route. Humans and other

animals may excrete these oocysts.

Transmission of this disease often

occurs through ingestion of the infective

oocysts from contaminated water or

food, but may also result from direct or

indirect contact with infected persons or

animals (Casemore, 1990; Cordell and

Addiss, 1994). Symptoms of

cryptosporidiosis include typical

gastrointestinal symptoms (Current et

al., 1983). As noted above, these may

persist for several days to several

months.

While cryptosporidiosis is generally a

self-limiting disease with a complete
69482 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

recovery in otherwise healthy persons,

it can be very serious in

immunosuppressed persons. EPA has a

particular concern regarding drinking

water exposure to Cryptosporidium,

especially in severely

immunocompromised persons, because

there is no effective therapeutic drug to

cure the disease. There have been a

number of waterborne disease outbreaks

caused by Cryptosporidium in the

United States, United Kingdom and

many other countries (Rose, 1997).

There appears to be an immune

response to Cryptosporidium, but it is

not known if this results in protection

(Fayer and Ungar, 1986).

One of the key regulations EPA has

developed and implemented to counter

pathogens in drinking water is the

SWTR. Among its provisions, the rule

requires that a surface water system

have sufficient treatment to reduce the

source water concentration of Giardia

and viruses by at least 99.9% (3 log) and

99.99% (4 log), respectively. A

shortcoming of the SWTR is that the

rule does not specifically control for the

protozoan Cryptosporidium. The first

report of a recognized outbreak caused

by Cryptosporidium was published

during the development of the SWTR

(D’Antonio et al., 1985).

In terms of occurrence,

Cryptosporidium is common in the

environment. Runoff from unprotected

watersheds allows transport of these

microorganisms to water bodies used as

intake sites for drinking water treatment

plants. A particular public health

challenge is that simply increasing

existing disinfection levels above those

most commonly practiced in the United

States today does not appear to be an

effective strategy for controlling

Cryptosporidium, because the

Cryptosporidium oocyst is especially

resistant to disinfection practices

commonly used at water treatment

plants. Today’s rule addresses the

concern of passage of Cryptosporidium

through physical removal processes

during water treatment. It also

strengthens the effectiveness and

reliability of physical removal for

particulate matter and microorganisms

in general, thereby reducing the

likelihood of the disinfection barrier

being over challenged. Waterborne

disease outbreaks have been associated

with a high level of particles passing

through a water treatment plant (Fox

and Lytle, 1996). This presents a

significant public health concern.

Hence, there is a need to optimize

treatment reliability and to enhance

physical removal efficiencies to

minimize the Cryptosporidium levels in

finished water. This rule, with tightened

turbidity performance criteria and

required individual filter monitoring, is

formulated to address these public

health concerns.

3. Regulatory Negotiation Process

In 1992 EPA initiated a negotiated

rulemaking to address public health

concerns associated with disinfectants,

DBPs and microbial pathogens. The

negotiators included representatives of

State and local health and regulatory

agencies, public water systems, elected

officials, consumer groups and

environmental groups. The Reg. Neg.

Committee met from November 1992

through June 1993.

Early in the process, the negotiators

agreed that large amounts of information

necessary to understand how to

optimize the use of disinfectants to

concurrently minimize microbial and

DBP risk on a plant-specific basis were

unavailable. Nevertheless, the Reg. Neg.

Committee agreed that EPA propose a

Stage 1 DBPR to extend coverage to all

community and nontransient

noncommunity water systems that use

disinfectants, reduce the current TTHM

MCL, regulate additional DBPs, set

limits for the use of disinfectants, and

reduce the level of organic precursor

compounds in the source water that

may react with disinfectants to form

DBPs.

EPA’s most significant concern in

developing regulations for disinfectants

and DBPs was the need to ensure that

adequate treatment be maintained for

controlling risks from microbial

pathogens. One of the major goals

addressed by the Reg. Neg. Committee

was to develop an approach that would

reduce the level of exposure from

disinfectants and DBPs without

undermining the control of microbial

pathogens. The intention was to ensure

that drinking water is microbiologically

safe at the limits set for disinfectants

and DBPs and that these chemicals do

not pose an unacceptable health risk at

these limits. Thus, the Reg. Neg.

Committee also considered a range of

microbial issues and agreed that EPA

should also propose a companion

microbial rule (IESWTR).

Following months of intensive

discussions and technical analysis, the

Reg. Neg. Committee recommended the

development of three sets of rules: a

two-staged approach for the DBPs

(proposal: 59 FR 38668, July 29, 1994)

(EPA, 1994a), an ‘‘interim’’ ESWTR

(proposal: 59 FR 38832, July 29, 1994)

(EPA, 1994b) and ‘‘long-term’’ ESWTR,

and an Information Collection Rule

(proposal: 59 FR 6332, February 10,

1994) (EPA, 1994c) (promulgation:

61FR24354, May 14, 1996) (EPA,

1996b). The approach used in

developing these proposals considered

the constraints of simultaneously

treating water to control for both

microbial contaminants and

disinfectants/DBPs.

The Reg. Neg. Committee agreed that

the schedules for IESWTR and

LTESWTR should be ‘‘linked’’ to the

schedule for the Stage 1 DBPR to assure

simultaneous compliance and a

balanced risk-risk based

implementation. The Reg. Neg.

Committee agreed that additional

information on health risk, occurrence,

treatment technologies, and analytical

methods needed to be developed in

order to better understand the risk-risk

tradeoff, and how to accomplish an

overall reduction in health risks from

both pathogens and disinfectants/DBPs.

Finally, the Reg. Neg. Committee

agreed that to develop a reasonable set

of rules and to understand more fully

the limitations of the current SWTR

additional field data were critical. Thus,

a key component of the regulation

negotiation agreement was the

promulgation of the ICR previously

described.

4. Federal Advisory Committee Process

In May 1996, the Agency initiated a

series of public informational meetings

to provide an update on the status of the

1994 proposal and to review new data

related to microbial and DBP regulations

that had been developed since July

1994. In August 1996, Congress enacted

the 1996 SDWA Amendments which

contained a number of new

requirements, as discussed above, as

well as specifying deadlines for final

promulgation of the IESWTR and Stage

1 DBPR. To meet these deadlines and to

maximize stakeholder participation, the

Agency established the MicrobialDisinfectants/Disinfection Byproducts

(M–DBP) Advisory Committee under the

Federal Advisory Committee Act

(FACA) in March 1997, to collect, share,

and analyze new information and data,

as well as to build consensus on the

regulatory implications of this new

information. The Committee consisted

of 17 members representing EPA, State

and local public health and regulatory

agencies, local elected officials, drinking

water suppliers, chemical and

equipment manufacturers, and public

interest groups.

The M–DBP Advisory Committee met

five times in March through July 1997

to discuss issues related to the IESWTR

and Stage 1 DBPR. Technical support

for these discussions was provided by a

Technical Work Group (TWG)

established by the Committee at its first

meeting in March 1997. The
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69483

Committee’s activities resulted in the

collection, development, evaluation,

and presentation of substantial new data

and information related to key elements

of both proposed rules. The Committee

reached agreement on a number of

major issues that were discussed in

Notices of Data Availability (NODA) for

the IESWTR (62 FR 59486, November 3,

1997) (EPA, 1997a) and the Stage 1

DBPR (62 FR 59388, November 3, 1997)

(EPA, 1997b). The major issues

addressed by the Committee and in the

NODAs include: (1) Maintain the

proposed MCLs for TTHMs, HAA5 and

bromate; (2) modify the enhanced

coagulation requirements as part of DBP

control; (3) include a microbial

benchmarking/profiling to provide a

methodology and process by which a

PWS and the State, working together,

assure that there will be no significant

reduction in microbial protection as the

result of modifying disinfection

practices in order to meet MCLs for

TTHM and HAA5; (4) continue credit

for compliance with applicable

disinfection requirements for

disinfection applied at any point prior

to the first customer, consistent with the

existing SWTR; (5) modify the turbidity

performance requirements and add

requirements for individual filters; (6)

establish an MCLG for Cryptosporidium;

(7) add requirements for removal of

Cryptosporidium; (8) provide for

mandatory sanitary surveys; and (9) a

commitment to additional analysis of

the role of Cryptosporidium inactivation

as part of a multiple barrier concept in

the context of a subsequent Federal

Register microbial proposal. The new

data and analysis supporting the

technical areas of agreement were

summarized and explained at length in

EPA’s 1997 NODAs. The Committee’s

recommendations are embodied in an

Agreement In Principle document dated

July 15, 1997.

5. Overview of 1994 Proposal and 1997

Notice of Data Availability

EPA proposed to amend the Surface

Water Treatment Rule in 1994 to

provide additional protection against

disease-causing organisms (pathogens)

in drinking water (59 FR 38832: July 29,

1994). In November 1997 EPA

published a Notice of Data Availability

(62 FR 59486) (EPA, 1997a, b) that

summarized the 1994 proposal;

described new data and information that

the Agency had obtained and analyses

that had been developed since the

proposal; provided information

concerning the July 1997

recommendations of the M–DBP

Advisory Committee described above on

key issues related to the proposal; and

requested comment on these

recommendations as well as on other

regulatory implications that flowed from

the new data and information. The

Agency also solicited additional data

and information that were relevant to

the issues discussed in the Notice. In

addition, EPA provided notice that the

Agency was re-opening the comment

period for the 1994 proposal for 90 days.

EPA also requested that any information

that members of the public would like

the Agency to consider as part of the

final rule development process

regarding data or views submitted to the

Agency since the close of the comment

period on the 1994 proposal be formally

resubmitted during the reopened 90-day

comment period unless already in the

underlying record in the Docket for the

Notice of Data Availability.

II. Summary of the Final Rule

The primary purposes of the IESWTR

are (1) to improve control of microbial

pathogens in drinking water,

particularly for the protozoan

Cryptosporidium, and (2) to guard

against significant increases in

microbial risk that might otherwise

occur when systems implement the

Stage 1 Disinfectants/Disinfection

Byproducts Rule. Major components of

the IESWTR include the following

provisions:

(a) A Maximum Contaminant Level

Goal (MCLG) of zero is established for

the protozoan genus Cryptosporidium.

(b) Surface water systems serving

10,000 or more people, that are required

to filter under the SWTR, must achieve

at least 2 log removal of

Cryptosporidium. Systems that use

conventional or direct filtration meet

this requirement if they comply with

strengthened turbidity performance

standards for combined filter effluent

(described below) and the current

requirements under the SWTR (e.g.,

meet design and operating conditions as

specified by the State). Systems that use

slow sand filtration or diatomaceous

earth meet the 2 log removal

requirement if they are in compliance

with existing turbidity performance

standards under the SWTR (less than or

equal to 1 NTU in at least 95% of

measurements taken each month or, for

slow sand, alternative criteria as

approved by the State; and a maximum

of 5 NTU).

(c) The rule includes a series of

requirements related to turbidity. These

address the following:

Strengthened turbidity performance

requirements for the combined filter

effluent. For all surface water or GWUDI

systems that use conventional treatment

or direct filtration, serve 10,000 or more

people, and are required to filter: (a) The

turbidity level of a system’s combined

filtered water at each plant must be less

than or equal to 0.3 NTU in at least 95

percent of the measurements taken each

month, and (b) the turbidity level of a

system’s combined filtered water at each

plant must at no time exceed 1 NTU.

For both the maximum and the 95th

percentile requirements, compliance is

determined based on measurements of

the combined filter effluent at four-hour

intervals.

Individual Filter Requirements. All

surface water or GWUDI systems that

use conventional or direct filtration,

serve 10,000 or more people, and are

required to filter must conduct

continuous monitoring of turbidity for

each individual filter and must provide

an exceptions report to the State on a

monthly basis. Exceptions reporting

must include the following: (1) Any

individual filter with a turbidity level

greater than 1.0 NTU based on two

consecutive measurements fifteen

minutes apart; and (2) any individual

filter with a turbidity level greater than

0.5 NTU at the end of the first 4 hours

of filter operation based on two

consecutive measurements fifteen

minutes apart. A filter profile (which is

a graphical representation of an

individual filter performance) must be

produced within seven days of the

exceedance if no obvious reason for the

abnormal filter performance can be

identified.

If an individual filter has turbidity

levels greater than 1.0 NTU based on

two consecutive measurements fifteen

minutes apart at any time in each of

three consecutive months, the system

must make an exceptions report and

conduct a self-assessment of the filter. If

an individual filter has turbidity levels

greater than 2.0 NTU based on two

consecutive measurements fifteen

minutes apart at any time in each of two

consecutive months, the system must

make an exception report and arrange

for the conduct of a Comprehensive

Performance Evaluation (CPE) by the

State or a third party approved by the

State.

State Authority. States must have

rules or other authority to require

systems to conduct a Composite

Correction Program (CCP) and to assure

that systems implement any follow-up

recommendations that result as part of

the CCP. The CCP consists of two

elements—a CPE and Comprehensive

Technical Assistance (CTA). The CPE is

a thorough review and analysis of a

plant’s performance-based capabilities

and associated administrative, operation

and maintenance practices. It is

conducted to identify factors that may
69484 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

be adversely impacting a plant’s

capability to achieve compliance and

emphasizes approaches that can be

implemented without significant capital

improvements. The CPE must include

the following components: (1)

Assessment of plant performance; (2)

evaluation of major unit processes; (3)

identification and prioritization of

performance limiting factors; (4)

assessment of the applicability of

comprehensive technical assistance; and

(5) preparation of a CPE report. A CTA

is the performance improvement phase

that is implemented if the CPE results

indicate improved performance

potential. During the CTA phase, the

system must identify and systematically

address plant-specific factors. The CTA

is a combination of utilizing CPE results

as a basis for follow up, implementing

process control priority-setting

techniques, and maintaining long-term

involvement to systematically train staff

and administrators.

(d) Microbial benchmarking/profiling

requirements are included to provide a

methodology and process by which a

public water system and the State,

working together, assure that there will

be no significant reduction in microbial

protection as the result of significant

disinfection practice modifications in

order to meet MCLs for TTHM and

HAA5. The disinfection profiling

requirement included in today’s rule

applies to surface water systems serving

10,000 or more people and which have,

based on a one year running annual

average of representative samples taken

in the distribution system, (1) measured

TTHM levels of at least 80% of the MCL

(0.064 mg/L) or (2) measured HAA5

levels of at least 80% of the MCL (0.048

mg/L). Those PWSs required to develop

a disinfection profile that subsequently

decide to make a significant change in

disinfection practice must consult with

the State prior to implementing such a

change.

(e) States are required to conduct

sanitary surveys for all public water

systems using surface water or ground

water under the direct influence of

surface water, regardless of system size.

Sanitary surveys are required no less

frequently than every three years for

community systems and no less

frequently than every five years for

noncommunity systems. For community

systems determined by the State to have

outstanding performance based on prior

sanitary surveys, subsequent sanitary

surveys may be conducted no less

frequently than every five years. States

must 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, indicating how

and on what schedule the system will

address significant deficiencies noted in

the survey. States must also have the

appropriate rules or other authority to

assure that facilities take the steps

necessary to address significant

deficiencies identified in the survey

report that are within the control of the

PWS and its governing body.

(f) Cryptosporidium is added to the

definition of ground water under the

direct influence of surface water (for

systems serving 10,000 or more people).

(g) Cryptosporidium is added to the

watershed protection requirements for

systems that are avoiding filtration (for

systems serving 10,000 or more people).

(h) Surface Water and GWUDI

systems serving 10,000 or more people

are required to cover all new treated

water reservoirs, holding tanks or other

storage facilities for which construction

begins after the effective date of the rule.

The Surface Water Treatment Rule

remains the base rule regulating public

water systems that use surface water

and ground water under the influence of

surface water. All systems, filtered and

unfiltered, must continue to comply

with all the requirements of the SWTR

and, where applicable, meet the new

requirements of the IESWTR. The

IESWTR’s requirements for filtered

systems are intended to ensure that

where a filtration plant is required to

protect public health, as specified in the

SWTR, that plant will be operating well

for the removal of Cryptosporidium and

other microorganisms. EPA wishes to

emphasize that compliance with today’s

requirements in no way relieves a

public water system of its obligation to

comply fully with pre-existing SWTR

requirements. With regard to unfiltered

systems in particular, development of

today’s rule was based on the

assumption of full compliance with all

filtration avoidance criteria in the

SWTR.

Finally, EPA notes that today’s

Federal Register also contains the final

Stage 1 Disinfectants/Disinfection

Byproducts Rule (DBPR). EPA proposed

this rule at the same time as the

IESWTR and has finalized it along with

the IESWTR.

III. Explanation of Today’s Action

A. MCLG for Cryptosporidium

1. Today’s Rule

The Agency is establishing an MCLG

of zero for Cryptosporidium, as

proposed. During the 1997 M–DBP

Advisory Committee discussions, the

Committee supported the proposed

establishment of an MCLG of zero for

Cryptosporidium. A key issue identified

by the Advisory Committee and public

commenters was whether the MCLG

should be set at the genus level (i.e.,

Cryptosporidium) or at the more specific

species level (i.e., C. parvum). Because

of the uncertainties regarding taxonomy,

cross reactions and cross transmission

among mammals, EPA believes it is

premature to establish the

Cryptosporidium MCLG at the species

level. In addition, the Agency believes

that establishing an MCLG for

Cryptosporidium at the genus level is

consistent with the Safe Drinking Water

Act, which requires EPA to set the

MCLG with an adequate margin of

safety (Section 1412(b)(4)(A)).

2. Background and Analysis

In the 1994 proposal of the IESWTR

(59 FR 145, p. 38855; July 29, 1994),

EPA proposed to establish an MCLG of

zero for Cryptosporidium. The Agency

based its proposal upon concerns about

significant health effects on persons

consuming inadequately treated surface

waters and ground water under the

influence of surface waters. Technical

justifications for the proposed MCLG

relied upon animal studies and human

epidemiology studies of waterborne

outbreaks of cryptosporidiosis.

Since the proposed rule, results of a

human feeding study have become

available which further warrant the

establishment of an MCLG of zero (1997

NODA 59492). DuPont et al. (1995) fed

29 healthy volunteers single doses

ranging from 30 to 1 million C. parvum

oocysts obtained from a calf. Of the 16

volunteers who received 300 or more

oocysts, 88% became infected. Of the

five volunteers who received the lowest

dose (30 oocysts), one became infected.

According to a mathematical model

based upon the DuPont et al. data, if an

individual ingests a single viable oocyst

there is about a 0.5% chance of

infection (Haas et al., 1996). The

probability of infection from C. parvum

may be different for different strains.

In the process of further reviewing

new information since 1994, EPA has

re-examined the issues related to setting

an MCLG at the genus level versus the

species level. This issue was discussed

in some detail during the M–DBP

Advisory Committee meetings.

Currently, the classification of a number

of Cryptosporidium species is based, in

part, on the animal host from which

they were isolated. The Agency is aware

that investigators have not found a

Cryptosporidium species other than C.

parvum that infects humans (with one

highly questionable exception). To the

Agency’s knowledge, however, no

human infectivity studies have been

conducted to date with any species
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69485

other than C. parvum. Moreover, the

taxonomy of the genus Cryptosporidium

is uncertain and changing (Tzipori and

Griffiths, 1998; Fayer et al., 1997). As a

result, EPA cannot preclude the

possibility that a new classification of

the species comprising the genus

Cryptosporidium may include more

than one species capable of infecting

humans. Recently, for example, Peng et

al. (1997) analyzed 39 isolates of C.

parvum from humans and cattle and

found they could be separated into

either of two genotypes, one of which

could infect humans but not cattle or

mice. In the future, these two genotypes

may be separated into two different

species.

In addition to the taxonomic issue,

the current tests for C. parvum in stool

specimens and water, which involve the

microscopic examination of a stained

specimen, may give positive results for

Cryptosporidium species other than C.

parvum. Often this results because other

Cryptosporidium species (as well as

other microorganisms) may react with

the stains used to detect C. parvum.

This is especially true for the commonly

used acid-fast stain. In addition, C.

parvum oocysts do not differ in size and

shape from those of C. baileyi and C.

meleagridis (Arrowood, 1997). As a

result, it is not necessarily certain that

oocysts in a human fecal specimen

identified by a clinical laboratory as C.

parvum are always C. parvum. (In

general, clinical labs do not use a stain

or other procedure that can distinguish

between C. parvum and other

Cryptosporidium species).

The Agency is aware that a few

attempts have been made to infect one

type of animal (e.g., mammals) with

Cryptosporidium species isolated from

other types of animals (e.g., birds),

generally without success (Fayer, 1997).

In addition, Graczyk et al. (1996b) found

that C. parvum was not transmissible to

fish, amphibia, or reptiles. Nevertheless,

until more cross-species transmission

data are available, the Agency cannot

foreclose on the possibility that species

other than C. parvum may be infective

to humans. In their review of the

literature, Fayer et al. (1990) concluded

that the success of transmission studies

is contingent upon not only species

specificity, but also the condition and

age of the oocysts, the route of

inoculation of oocysts, and the age and

immune status of the recipient.

Therefore, negative results to date on

transmission are not necessarily

conclusive regarding host specificity.

EPA believes that it is prudent to set

an MCLG at zero not only for taxonomic

reasons but also because of concern that

certain populations are at greater risk of

waterborne cryptosporidiosis than

others. This concern is heightened by

the fact that currently there is no cure

for cryptosporidiosis (for healthy

individuals the disease tends to be self

limiting). Thus, the importance of

prevention and avoidance of infection

becomes even more central to EPA’s

consideration of this issue. Until the

taxonomy of Cryptosporidium has been

clarified, EPA believes that an MCLG of

zero for Cryptosporidium at the genus

level is appropriate especially in light of

the statutory requirement to establish

MCLGs with ‘‘an adequate margin of

safety’’.

3. Summary of Major Comments

Regarding the value of the MCLG

most commenters supported the

establishment of a MCLG of zero for

Cryptosporidium. Reasons that were

given for their support included: (1)

Uncertainty exists in the infective dose

for both healthy and vulnerable

(immunocompromised) individuals; (2)

an MCLG of zero is consistent with the

regulatory approach for pathogens

under the existing Surface Water

Treatment Rule (SWTR); (3) one viable

oocyst can cause an infection at least in

some people; and (4) Cryptosporidium

has particularly adverse effects on

persons with immune disorders. No

commenter proposed an MCLG value

other than zero. Some commenters

opposed any MCLG for

Cryptosporidium, arguing that: (1)

Current levels of treatment have some

level of effectiveness against

Cryptosporidium transmission to

drinking water; (2) uncertainty exists

associated with the analytical

procedures used to detect

Cryptosporidium; (3) current technology

limits the ability to determine viability,

infectivity, and species; and (4) the

infectivity threshold has not been

determined.

EPA agrees with the commenters who

supported an MCLG of zero for

Cryptosporidium for reasons stated in

the previous section. EPA does not agree

with comments opposing any MCLG for

Cryptosporidium. While it is true that

current levels of treatment control

Cryptosporidium to some extent, studies

have found Cryptosporidium oocysts in

filtered water supplies of some

treatment plants (LeChevallier, 1991b;

LeChevallier, 1995). Therefore, the

Agency believes that regulation of

Cryptosporidium and enhanced

treatment practices are warranted.

Furthermore, the effectiveness of

treatment is irrelevant to the question of

setting an MCLG, which asks what is the

level of (uncontrolled) Cryptosporidium

in drinking water that will pose no risk

to the health of persons. For the reasons

discussed, that level is at zero. The

availability of effective treatment merely

ensures that EPA can regulate to control

the health risk from Cryptosporidium

reflected by the MCLG.

Comments which address the

uncertainty related to the analytical

method for Cryptosporidium and the

fact that current technology does not

allow viability, infectivity, and species

to be determined may relate to the issue

of whether EPA establishes an MCL

versus treatment technique

requirements for Cryptosporidium.

However, they are not compelling with

regard to the public health goal that

should be set for this contaminant.

With regard to the infectivity

threshold for Cryptosporidium,

according to a mathematical model

based upon the DuPont et al., 1995 data,

if an individual ingests a single viable

oocyst there is a 0.5% chance of

infection (Haas et al., 1996). It is known

that Cryptosporidium oocysts are

capable of causing an infection in both

healthy and seriously ill individuals.

Death has been associated with some

cryptosporidiosis cases, particularly

among sensitive subpopulations (i.e.,

immunocompromised individuals)

(Hoxie et al., 1997). For such reasons,

EPA considers an MCLG of zero for

Cryptosporidium to be appropriate.

EPA also received comments on

whether the MCLG for Cryptosporidium

should be set at the genus or the species

level. Commenters offered several

reasons for supporting an MCLG for C.

parvum, as opposed to

Cryptosporidium. Several professed that

only C. parvum could infect humans,

and therefore EPA should establish an

MCLG based on that particular species.

Commenters also contended that if, in

future regulations, EPA were to

establish a treatment technique

requirement based on the

Cryptosporidium density in the source

water, publishing an MCLG for

Cryptosporidium at the genus level

might require systems to provide an

additional level of treatment for

Cryptosporidium species that are not

known to be infectious to humans. In

contrast, other commenters who

supported the establishment of an

MCLG for Cryptosporidium at the genus

level stated that, unless further research

justifies an MCLG at the species level,

the MCLG should be set at the genus

level. They reasoned that

Cryptosporidium method limitations

argued for setting the MCLG at the

genus level.

In response to comments that did not

support establishing an MCLG of zero

for Cryptosporidium at the genus level,
69486 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

EPA has carefully considered the issue

of genus versus species level for

Cryptosporidium. As mentioned earlier,

EPA concludes that there exists much

uncertainty regarding Cryptosporidium

taxonomy, cross reactions and cross

transmissions. Thus, EPA cannot

conclude that these other species pose

no health risk. For reasons mentioned

above, the Agency believes that it is

more appropriate to establish an MCLG

for Cryptosporidium at the genus level

at this time. This decision does not

affect the level of treatment required

under the IESWTR. EPA will revisit the

impact of the MCLG in the context of

future rules that include consideration

of risk-based options.

B. Removal of Cryptosporidium by

Filtration

1. Today’s Rule

Today’s final rule establishes a

requirement for 2-log removal of

Cryptosporidium for surface water and

GWUDI systems serving 10,000 or more

people that must filter under the SWTR.

The requirement for at least 99 percent

(2-log) removal of Cryptosporidium

applies between a point where the raw

water is not subject to recontamination

by surface water runoff and a point

downstream before or at the first

customer. As discussed below, the data

available to EPA indicate that rapid

granular filtration systems (i.e., systems

using conventional or direct filtration)

when operated under appropriate

coagulation conditions and optimized to

meet the turbidity performance

standards of the IESWTR (less than or

equal to 0.3 NTU in 95% of the

measurements each month and a

maximum of 1 NTU) are achieving at

least 2-log removal.

2. Background and Analysis

The 1994 proposal to amend the

Surface Water Treatment Rule included

several proposed treatment alternatives.

Two of these alternatives—Alternatives

B and C—specifically addressed

Cryptosporidium. Alternative B

envisioned treatment options for

Cryptosporidium based on levels of

source water occurrence. Alternative C

called for 99% (2-log) removal of

Cryptosporidium. EPA was unable to

consider Alternative B for the IESWTR

because occurrence data and related

analysis from the ICR sampling and

analysis survey discussed above were

not available in time to meet the

statutory promulgation deadline of

November 1998. For the reasons

outlined below and as recommended by

the M–DBP Advisory Committee, EPA is

proceeding with a 2-log removal

requirement for Cryptosporidium for

surface water and GWUDI systems

serving 10,000 or more people that are

required to filter under the SWTR.

As part of the 1997 M–DBP Advisory

Committee process, substantial new

data and information related to removal

of Cryptosporidium by filtration were

collected, evaluated and analyzed. The

Committee recommended adoption of a

2-log Cryptosporidium removal

requirement for all surface water

systems that serve more than 10,000

people and are required to filter. The

Committee also recommended that

systems which use rapid granular

filtration (direct filtration or

conventional filtration treatment) and

meet today’s strengthened combined

filter effluent turbidity requirements

would be in compliance with the

requirement for at least a 2-log removal

of Cryptosporidium. Systems which use

slow sand filtration and diatomaceous

earth filtration and meet existing SWTR

turbidity performance requirements

(less than or equal to 1 NTU for the 95th

percentile or alternative criteria as

approved by the State) also would be in

compliance with the requirement for at

least a 2-log removal of

Cryptosporidium.

In November of 1997, EPA issued a

Notice of Data Availability (NODA)

which discussed new data and

information that the Agency had

obtained and analyses that had been

developed since the 1994 proposal. It

also summarized recommendations of

the M–DBP Advisory Committee on

Cryptosporidium removal. The 1997

NODA requested comment on the new

information, the Advisory Committee’s

recommendations, and on other

regulatory implications and impacts.

The November 3, 1997 NODA

provided new information regarding

eight studies (Patania et al., 1995;

Nieminski and Ongerth, 1995; Ongerth

and Pecoraro, 1995; LeChevallier and

Norton, 1992; LeChevallier et al., 1991b;

Foundation for Water Research, 1994;

Kelley et al., 1995; and West et al., 1994)

that indicated that rapid granular

filtration when operated under

appropriate coagulation conditions and

optimized to achieve a filtered water

turbidity of less than 0.3 NTU should

achieve at least 2-log of

Cryptosporidium removal. These studies

were analyzed as part of the 1997

IESWTR NODA.

3. Summary of Major Comments

In response to the 1994 Proposal,

most commenters addressing the issue

of treatment alternatives supported

Alternative C which would require 2-log

physical removal of Cryptosporidium.

Some opposed any treatment

requirement greater than a 2-log removal

due to a lack of better understanding of

dose-response, effectiveness of

treatment and analyses to justify the

higher treatment costs involved. Today’s

rule requires at least 2-log removal for

Cryptosporidium. EPA will revisit

issues related to further control of

Cryptosporidium in future rulemakings.

The majority of commenters to the

November 1997 NODA agreed with the

appropriateness of establishing a 2-log

removal requirement for

Cryptosporidium in the IESWTR,

although some commenters had

additional concerns. One major concern

was that a quantitative relationship

between removal of Cryptosporidium

and lowered turbidity was premature

and had not been established. EPA

believes that the studies identified in

the NODA illustrate the removal

efficiencies for Cryptosporidium by

several filtration technologies. While

these studies demonstrated a range of

Cryptosporidium log-removals, it is

important to realize that 2-log removal

was consistently obtainable at turbidity

levels of less than 0.3 NTU when

systems were operated under

appropriate coagulation conditions and

optimized to achieve a filtered water

turbidity level of less than 0.3 NTU.

EPA will continue to assess data for

control of Cryptosporidium by physical

removal and disinfection as it becomes

available, and will consider such data in

subsequent regulations.

Another significant issue noted by

several commenters was that systems

should be provided the opportunity to

demonstrate greater log removal of

Cryptosporidium. Consistent with a key

point made during M–DBP Advisory

Committee discussions on this issue,

EPA takes this opportunity to note the

Agency’s position that the requirement

for at least 2-log removal is not intended

to prevent a facility from demonstrating

that it can achieve higher than 2-log

removal of Cryptosporidium on a sitespecific basis or States from

demonstrating based on site-specific

information that a specific facility may

actually be achieving less than 2-log

removal of Cryptosporidium even

though it is meeting strengthened

turbidity standards of 0.3 NTU for the

95th percentile and a maximum of 1

NTU.

C. Turbidity Control

1. Today’s Rule

Today’s rule establishes a number of

requirements for filtration performance

and filter monitoring and reporting,

outlined below, which apply to surface
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69487

water systems or ground water under

the direct influence of surface water

(GWUDI) that serve 10,000 or more

people and are required to filter under

the SWTR. The basis for these

provisions is explained at greater length

in background sections of the 1997

IESWTR NODA.

Combined Filter Effluent Requirements

For conventional and direct filtration

systems, the turbidity level of

representative samples of a system’s

combined filter effluent water must be

less than or equal to 0.3 NTU in at least

95 percent of the measurements taken

each month. The turbidity level of

representative samples of a system’s

filtered water must at no time exceed 1

NTU. For slow sand and diatomaceous

earth filtration, the turbidity level of

representative samples of a system’s

filtered water must be less than or equal

to 1 NTU in at least 95 percent of the

measurements taken each month and

the turbidity level of representative

samples of a system’s filtered water

must at no time exceed 5 NTU (no

change from the combined filter effluent

turbidity requirements in the 1989

SWTR). For both the maximum and

95th percentile requirements,

compliance is determined based on

measurements of the combined filter

effluent at four-hour intervals.

In carrying out these combined

effluent requirements, and the

individual filter requirements described

below, systems must use methods for

turbidity measurement previously

approved by EPA. These are Method

2130B, published in Standard Methods

for the Examination of Water and

Wastewater (19th ed.); Great Lakes

Instrument Method 2; and the revised

EPA Method 180.1, approved in August

1993 in Methods for the Determination

of Inorganic Substances in

Environmental Samples (EPA–600/R–

93–100). EPA notes that today’s rule

requires the measurement of turbidity.

Turbidity is a method-defined

parameter. Turbidity therefore is not a

candidate for, and will not be subject to,

the performance-based measurements

system.

Individual Filter Requirements

Conventional and direct filtration

systems must conduct continuous

monitoring of turbidity for each

individual filter and must provide an

exceptions report to the State on a

monthly basis as part of the existing

combined filter effluent reporting

process. Exceptions reporting must

include the following: (1) Any

individual filter with a turbidity level

greater than l.0 NTU based on two

consecutive measurements fifteen

minutes apart; and (2) any individual

filter with a turbidity level greater than

0.5 NTU at the end of the first 4 hours

of filter operation based on two

consecutive measurements fifteen

minutes apart. The system must

produce a filter profile for either

situation if no obvious reason for the

abnormal filter performance can be

identified. EPA is including a

discussion on filter profiles in its

guidance document on turbidity which

is currently being developed with input

from stakeholders.

Individual Filter Follow-Up Activities

If an individual filter has turbidity

levels greater than l.0 NTU based on two

consecutive measurements fifteen

minutes apart at any time in each of

three consecutive months, the system

must, in addition to filing an exceptions

report, conduct a self-assessment of the

filter. The self-assessment must consist

of at least the following components: (1)

Assessment of filter performance; (2)

development of a filter profile; (3)

identification and prioritization of

factors limiting filter performance; (4)

assessment of the applicability of

corrections; and (5) preparation of a

filter self-assessment report. The system

must conduct the self-assessment within

14 days of the exceedance and report to

the State that the self-assessment was

conducted. If an individual filter has

turbidity levels greater than 2.0 NTU

based on two consecutive measurements

fifteen minutes apart at any time in each

of two consecutive months, the system

must file an exceptions report and must

no later than 30 days following the

exceedance arrange for the conduct of a

CPE by the State or a third party

approved by the State. The CPE must be

completed and submitted to the State no

later than 90 days following the

exceedance.

2. Background and Analysis

A primary focus of the 1994 proposal

was the establishment of treatment

requirements that would address public

health risks from high densities of

pathogens in poor quality source waters

and from the waterborne pathogen

Cryptosporidium. Approaches outlined

in the 1994 proposal included treatment

requirements based on site-specific

concentrations of pathogens in source

water and a proposed 2-log removal

requirement for Cryptosporidium by

filtration.

EPA specifically requested comment

on what criteria, if any, should be

included to ensure that systems

optimize treatment plant performance

and on whether any of the existing

turbidity performance criteria should be

modified (e.g., should systems be

required to base compliance with the

turbidity standards on individual filter

effluent monitoring in lieu of or in

addition to monitoring the confluence of

all filters; and should any performance

standard value be changed). In addition,

the Agency also requested comment in

the 1994 proposal on possible

supplemental requirements for State

notification of persistent high turbidity

levels (e.g., broadening the requirements

for State notification of turbidity

exceedances).

The 1997 M-DBP Advisory Committee

meetings resulted in the collection,

development, evaluation, and

presentation of substantial data and

information related to turbidity control.

The Committee’s recommendations are

reflected in today’s rule.

The November 3, 1997 IESWTR

NODA discussed new data and

information regarding turbidity control

with respect to three areas: (1) Current

turbidity levels at systems throughout

the country; (2) individual filter

performance; and (3) turbidity

measurement.

Current Turbidity Levels

The November 3, 1997 NODA

discussed three data sets that

summarized the historical turbidity

performance of various filtration plants

(AWWSC, 1997; Bissonette, 1997; SAIC,

1997b). These were evaluated to assess

the national impact of modifying

existing turbidity requirements. Each of

the data sets was analyzed to assess the

current performance of plants with

respect to the number of months in

which selected 95th percentile and

maximum turbidity levels were

exceeded. The data show that upwards

of 90% of the systems are currently

meeting the new requirements of a

maximum turbidity limit of 1 NTU.

With respect to the 95th percentile

turbidity limit, roughly 78% of the

systems are currently meeting the new

requirement of 0.3 NTU. Estimates for

systems needing to make changes to

meet a turbidity performance limit of

0.3 NTU were based on the ability of

systems currently to meet a 0.2 NTU.

This assumption was intended to take

into account a utility’s concern with

possible turbidity measurement error

and to reflect the expectation that a

number of utilities will ‘‘aim’’ lower

than the regulatory performance level to

assure compliance. The percentage of

systems estimated to modify treatment

practices to meet the revised turbidity

requirements (i.e., 0.3 NTU 95th

percentile and 1 NTU maximum

combined filter effluent levels) is
69488 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

approximately 50%. Based on the

turbidity performance data, EPA

assumed that for systems serving less

than 100,000 people, 51.2 percent of the

systems can be expected to make

treatment changes to consistently

comply with a monthly 95th percentile

limit of 0.3 NTU. Similarly, for systems

serving over 500,000 people, EPA

assumed that 41.7 percent can be

expected to make treatment changes to

comply with a 0.3 NTU regulatory limit.

For systems serving 100,000 to 500,000

people, EPA assumed that 46.5 percent

of systems can be expected to make

changes. As discussed in greater detail

in the November 3, 1997 NODA, the

tighter turbidity performance criteria for

combined filter effluent in today’s rule

reflect actual current performance for a

substantial percentage of systems

nationally. Revising the turbidity

criteria effectively ensures that these

systems continue to perform at these

levels (in addition to improving

performance of systems that currently

meet existing SWTR criteria but operate

at turbidity levels higher than those in

today’s final rule).

Individual Filter Performance

Several of the studies published since

1994, considered by both EPA and the

M-DBP Advisory Committee and

outlined in the 1997 NODA, note that

the greatest potential for a peak in

turbidity (and thus, pathogen breakthrough) is near the beginning of the

filter run after filter backwash or start

up of operation (Amirtharajah 1988;

Bucklin et al. 1988; Cleasby 1990; and

Hall and Croll 1996). During a turbidity

spike, significant amounts of particulate

matter (including oocysts, if present)

may pass through the filter. Various

factors affect the duration and

amplitude of filter spikes, including

sudden changes to the flow rate through

the filter, treatment of the filter

backwash water, filter-to-waste

capability, and site-specific water

quality conditions. As discussed in the

1997 IESWTR NODA, these issues

highlighted the need to ensure that

systems have a greater understanding of

individual filter performance and thus

for establishment of individual filter

monitoring and reporting requirements.

Turbidity Measurement

The November 3, 1997 NODA

discussed several issues relating to

measurement of turbidity. It was noted

that issues exist concerning the

accuracy and precision of turbidity

measurement due to design criteria,

calibration methods, calibration

standards, and sampling technique.

Performance evaluation (PE) studies

conducted by EPA provide an

indication of the current level of

accuracy and precision for turbidity

measurements among different

laboratories for a common synthetically

prepared water. In PE studies, PE

samples with known turbidity levels are

sent to participating laboratories (which

are not informed of the turbidity level).

Laboratories participating in these

studies used turbidimeters from various

manufacturers and conducted their

analysis in accordance with calibration

and analytical procedures they are

familiar with. Thus, the variability of

the results reflects differences resulting

from using different turbidimeter

models and methods and the effects of

different laboratory procedures. Four PE

studies were discussed in the NODA

with turbidities in the range of 0.35 to

0.72 NTU. The Relative Standard

Deviations (RSD) at turbidity levels

considered in these PE studies are

slightly below 20%.

3. Summary of Major Comments

In response to the 1994 proposal, EPA

received a range of comments both in

support of and in opposition to

optimizing existing water treatment

processes to address Cryptosporidium

removal. Several commenters supported

tighter turbidity standards as well as

monitoring of individual filters. Other

commenters suggested no modifications

be made to turbidity standards until

further implementation of the SWTR

and/or further supporting data was

gathered.

Commenters on the 1997 NODA

provided additional views on the

general subject of filtration performance

and turbidity. Commenters generally

supported tightening combined filter

effluent performance standards as well

as the establishment of individual filter

monitoring requirements. EPA agrees

with these comments, as reflected in

today’s rule. EPA also notes that

turbidity performance data that reflects

implementation of the SWTR was

analyzed as part of the M–DBP Advisory

Committee discussions and was

considered by the Committee in

developing the recommendations for

turbidity which are reflected in today’s

rule.

Several commenters discussed the

ability of systems to measure turbidity

at low levels (<0.3 NTU) with accuracy

and consistency. EPA believes that the

performance evaluation (PE) studies

cited in the NODA provide an

indication of the precision and accuracy

of turbidity measurements at low levels.

While turbidities in these studies only

ranged from 0.35 to 0.72 NTU, they

provided an understanding of the ability

to measure at such levels. EPA

recognizes that accurate and consistent

measurements are not only a function of

available technology but also a function

of a range of operator/technician factors

including calibration, maintenance,

training, and adherence to manufacturer

instructions. In conjunction with the

IESWTR, EPA is currently developing

guidance, with stakeholder input,

targeted at assisting owners/operators

with understanding turbidity as well as

focusing on the importance of accuracy

and consistency in turbidity

measurement, including the low level

measurement concerns noted by the

commenters.

Many commenters discussed the issue

of lime-softening plants and how the

new requirements would affect such

plants which, because of the softening

processes, have artificially elevated

levels of turbidity. The IESWTR allows

acidification of samples for the

combined filter effluent at lime

softening plants. In addition, EPA is

allowing systems that use lime softening

to apply to States for alternative

exceedance reporting levels for

individual filters if they can

demonstrate that higher turbidity levels

in individual filters are due to lime

carryover and not due to degraded filter

performance.

Several commenters noted that

special filters would present difficulties

in complying with the individual filter

monitoring requirements. While EPA

realizes that variations exist in filter

configurations and filters in use at

systems throughout the country, the

IESWTR will not seek to address the

specific requirements of each and every

one. EPA intends to provide States the

flexibility and the tools necessary to

effectively deal with special filters

discussed by the commenters on a more

appropriate case-by-case basis.

Another issue raised in public

comments was the need to clarify how

public notice requirements in the

IESWTR would be integrated with

future public notice requirements under

the SDWA. EPA notes that today’s

action addresses public notification by

using the existing public notification

language for microbiological

contaminants in 40 CFR 141.32 (e)(10)

for violations of treatment technique

requirements under the IESWTR. EPA

takes this opportunity to note that the

1996 amendments to the SDWA require

the Agency to make certain technical

changes to the public notice regulations.

EPA intends to propose changes to the

public notice requirements in the

Federal Register shortly after

promulgation of the IESWTR.

Applicable changes in the public notice
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69489

requirements, when they become

effective, will supersede today’s

provisions. EPA also takes this

opportunity to note that today’s rule

amends the Consumer Confidence

Report Regulation (CCR) to extend the

CCR requirements to apply to Subpart P

violations.

Several respondents indicated that it

would be necessary to provide guidance

materials to systems to aid in

compliance with these rules. EPA is

currently developing a number of

guidance manuals, with stakeholder

input, to aid systems in understanding

and complying with requirements. One

such manual will address issues of

turbidity control and filter performance.

D. Disinfection Benchmark for Stage 1

DBPR MCLs

1. Today’s Rule

Today’s rule establishes the

disinfection benchmark as a procedure

requiring certain PWSs to evaluate the

impact on microbial risk of proposed

changes in disinfection practice. It

reflects the recommendation of the M–

DBP Advisory Committee to develop a

mechanism that allows utilities and

States working together to assure that

pathogen control is maintained while

the Stage 1 DBPR provisions are

implemented. In essence, this procedure

involves a PWS charting daily levels of

Giardia lamblia inactivation for a period

of at least one year to create a profile of

inactivation performance. The PWS

must then use this profile to determine

a baseline or benchmark of inactivation

against which proposed changes in

disinfection practices can be measured.

However, only certain systems are

required to develop a profile and keep

it on file for State review during sanitary

surveys. When those systems required

to develop a profile plan a significant

change in disinfection practice, they

must submit the profile, along with an

analysis of how the proposed change

will affect the current disinfection

benchmark, to the State for review. The

disinfection benchmark provisions,

then, contain three major components:

applicability requirements,

characterization of disinfection practice,

and State review of proposed changes in

disinfection practice. Each of these

components is discussed in turn below.

Applicability

Systems are required to prepare a

disinfection profile if at least one of the

following criteria is met:

(1) TTHM levels are at least 80% of

the MCL (0.064 mg/L) as an annual

average

(2) Haloacetic acid (HAA5) levels are

at least 80% of the MCL (0.048 mg/L) as

an annual average

In connection with TTHM and HAA5

monitoring to create a disinfection

profile, the following provisions apply:

First, the TTHM annual average must

be the annual average during the same

period as is used for the HAA5 annual

average. Second, systems that have

collected TTHM and HAA5 data under

the ICR must use the results of samples

collected during the last 12 months of

monitoring unless the State determines

that there is a more representative

annual data set. Third, systems not

required to collect data under the ICR

but which have collected four

consecutive quarters of TTHM and

HAA5 data that substantially meet the

sample location, handling, and

analytical methods requirements of the

ICR may use those data if approved by

the State. (Systems must coordinate

with the State to confirm acceptability

of the existing data). Fourth, if the

system does not have four quarters of

acceptable HAA5 and TTHM data by the

end of 90 days following the IESWTR

promulgation date, the PWS must

conduct HAA5 and TTHM monitoring

to determine an annual average.

Alternatively, the system may elect to

conduct profiling, as described below,

and forego TTHM/HAA5 monitoring to

determine applicability. This

monitoring must be completed no later

than 15 months after promulgation of

this rule and conform to the monitoring

location requirements of the 1979

TTHM Rule and the analytical methods

in the May 1996 Information Collection

Rule.

Today’s rule applies profiling

requirements to systems with TTHM or

HAA5 concentrations of at least 80% of

the MCL, based upon the M–DBP

Advisory Committee technical

recommendation that this level will

cover most systems that might be

expected to modify their disinfection

practices to comply with the Stage 1

DBPR. Also, EPA previously considered

this 80% target level at the

recommendation of the 1992 Reg Neg

Committee to evaluate Stage 1 DBPR

compliance forecasts and costs, based

upon the judgment that most facilities

will take additional steps to ensure

continuing MCL compliance if they are

at or above this level.

Developing the Profile and Benchmark

Profiling is the characterization of a

system’s disinfection practice over a one

year period. The system can create the

profile by conducting new daily

monitoring and also by using

‘‘grandfathered’’ data (as explained

below). A disinfection profile consists of

a compilation of daily Giardia lamblia

log inactivations (plus virus

inactivations for systems using either

chloramines or ozone for primary

disinfection), computed over the period

of a year, based on daily measurements

of operational data (disinfectant residual

concentration(s), contact time(s),

temperature(s), and, where necessary,

pH).

Grandfathered data are those

operational data that a system has

previously collected at a treatment plant

during the course of normal operation.

These data may or may not have been

used previously for compliance

determinations with the SWTR. Those

systems that have all necessary data to

determine profiles using existing

operational data collected prior to

promulgation of the IESWTR may use

these data in developing profiles.

However, grandfathered data must be

substantially equivalent to operational

data that would be collected under this

rule. These data must be representative

of inactivation through the entire

treatment plant and not just of certain

treatment segments. The State

determines whether grandfathered data

are acceptable. (EPA believes that

grandfathered data used in constructing

profiles should be the most recent data

available, unless the State determines

that there is a more representative data.)

Systems required to develop

disinfection profiles under this rule

must exercise one of the following three

options:

Option 1—Systems must conduct

daily monitoring as described below.

This monitoring must begin no later

than 15 months after IESWTR

promulgation and must continue for a

period of one year. The data collected

from this monitoring must be used to

develop a one year disinfection profile;

Option 2—Systems that conduct

monitoring under this rule, as described

under Option 1, may also use one or two

years of acceptable grandfathered data,

in addition to the one year of new

operational data, in developing the

disinfection profile;

Option 3—Systems that have three

years of acceptable existing operational

data are not required to conduct

monitoring to develop the disinfection

profile under this rule. Instead, they

may use grandfathered data to develop

a three year disinfection profile.

Systems must coordinate with the State

to confirm acceptability of

grandfathered data no later than 15

months after promulgation of this rule,

but must conduct the required

monitoring until the State approves the

system’s request to use grandfathered
69490 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

data. In order to develop the profile, a

system must:

—Measure disinfectant residual

concentration (C, in mg/L) before or at

the first customer and just prior to

each additional point of disinfectant

addition, whether with the same or a

different disinfectant.

—Determine contact time (T, in

minutes) for each residual

disinfectant monitoring point during

peak flow conditions. T can be based

on either a tracer study or

assumptions based on contactor basin

geometry and baffling. However,

systems must use the same method for

both grandfathered data and new data.

—Measure water temperature (°C).

—Measure pH (for chlorine only).

The system must then convert daily

operational data to daily log inactivation

values for Giardia (and viruses when

chloramines or ozone is used for

primary disinfection) as follows:

—Determine CTcalc for each

disinfection segment.

—Determine CT99.9 (i.e., 3-log

inactivation) from tables in the SWTR

using temperature (and pH for

chlorine) for each disinfection

segment. Alternatively, States may

allow an alternate calculation

procedure (e.g. use of spreadsheet).

—For each segment, log inactivation =

(CTcalc/CT99.9)×3.0.

—Sum the log inactivations for each

segment to get the daily log

inactivation.

A log inactivation benchmark is then

calculated as follows:

1. Calculate the average log

inactivation of all the days for each

calendar month.

2. Determine the calendar month with

the lowest average log inactivation.

3. The lowest average month becomes

the critical period for that year.

4. If acceptable data from multiple

years are available, the average of

critical periods for each year becomes

the benchmark.

5. If only one year of data is available,

the critical period (lowest monthly

average inactivation level) for that year

is the benchmark.

State Review

If a system that is required to produce

a disinfection profile decides to make a

significant change in disinfection

practice after the profile is developed, it

must consult with the State before

implementing such a change.

Significant changes in disinfection

practice are defined as: (1) Moving the

point of disinfection (this is not

intended to) include routine seasonal

changes already approved by the State),

(2) changing the type of disinfectant or

(3) changing the disinfection process, (4)

making other modifications designated

as significant by the State. Supporting

materials for such consultation with the

State must include a description of the

proposed change, the disinfection

profile developed under this rule for

Giardia lamblia (and, if necessary,

viruses), and an analysis of how the

proposed change will affect the current

disinfection benchmark. In addition, the

State is required to review disinfection

profiles as part of its periodic sanitary

survey.

EPA is currently developing, with

stakeholder input, the Disinfection

Benchmarking Guidance Manual for

States and systems. This manual will

provide instruction on the development

of disinfection profiles, identification

and evaluation of significant changes in

disinfection practices, and

considerations for setting an alternative

benchmark. This manual will also

provide guidance for systems that are

required to develop a profile based on

virus inactivation instead of Giardia

lamblia inactivation.

2. Background and Analysis

A fundamental principle of the 1992–

93 regulatory negotiation reflected in

the 1994 proposal for the IESWTR was

that new standards for control of

disinfection byproducts must not result

in significant increases in microbial

risk. This principle was also one of the

underlying premises of the 1997 M-DBP

Advisory Committee’s deliberations,

i.e., that existing microbial protection

must not be significantly reduced or

undercut as a result of systems taking

the necessary steps to comply with the

Stage 1 DBPR. The Advisory Committee

reached agreement on the use of

microbial profiling and benchmarking

as a process by which a PWS and the

State, working together, assure that

there will be no significant reduction in

microbial protection as the result of

modifying disinfection practices in

order to meet MCLs for TTHM and

HAA5.

The strategy of disinfection profiling

and benchmarking stemmed from data

provided to the EPA and M-DBP

Advisory Committee by PWSs and

reviewed by stakeholders, in which the

baseline of microbial inactivation

(expressed as logs of Giardia lamblia

inactivation) demonstrated high

variability. Inactivation varied by

several log on a day-to-day basis at any

particular treatment plant and by as

much as tens of logs over a year due to

changes in water temperature, flow rate

(and, consequently, contact time),

seasonal changes in residual

disinfectant, pH, and disinfectant

demand (and, consequently,

disinfectant residual). There were also

differences between years at individual

plants. To address these variations, MDBP stakeholders developed the

procedure of profiling a plant’s

inactivation levels over a period of at

least one year, and then establishing a

benchmark of minimum inactivation as

a way to characterize disinfection

practice. This approach makes it

possible for a plant that may need to

change its disinfection practice in order

to meet DBP MCLs to determine the

impact the change would have on its

current level of disinfection and,

thereby, to assure that there is no

significant increase in microbial risk.

3. Summary of Major Comments

In the 1997 IESWTR NODA, EPA

requested public comment on all

aspects of the benchmarking procedure,

along with any alternative suggestions,

from stakeholders and other interested

parties. EPA specifically requested

comment on the following issues:

Applicability requirements;

characterization of disinfection

practices and components; use of TTHM

and HAA5 data from the same time

period instead of TTHM data from one

year and HAA5 data from another;

definition of significant changes to

disinfection practice; different

approaches to evaluating possible

changes in disinfection practice against

a disinfection profile; and whether the

use of grandfathered data, if available,

should be mandatory for profiling and

benchmarking.

The majority of comments on the

overall benchmarking procedure

outlined in the 1997 IESWTR NODA

were positive. Commenters

acknowledged the procedure as a way to

maintain microbial control in systems

changing their disinfection practices to

comply with DBP MCLs. However, a

significant area of concern expressed in

comments was that if PWSs believe they

will be held to a relatively higher

regulatory standard as a result of

maintaining a greater level of

disinfection than is currently required,

then some PWSs may reduce log

inactivation during profiling in order to

lower their benchmarks. EPA

emphasizes that benchmarking is not

intended to function as a regulatory

standard. Rather, the objective of the

disinfection benchmark is to facilitate

interactions between the States and

PWSs for the purpose of assessing the

impact on microbial risk of proposed

significant changes to existing

disinfection practices. Final decisions

regarding levels of disinfection beyond
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69491

those required by the SWTR that are

necessary to protect public health will

continue to be left to the States. For this

reason EPA has not mandated specific

evaluation protocols or decision

matrices for analyzing changes in

disinfection practice. EPA is, however,

providing support to the States in

making these analyses through the

issuance of guidance. This approach is

consistent with a majority of comments

on this issue which requested that EPA

not require specific procedures for the

setting of alternative benchmarks but,

rather, provide guidance to States.

Several commenters suggested that

instead of requiring profiling and

benchmarking in regulations, EPA

should place these procedures in

guidance and allow the States to

implement them at their discretion. EPA

considers benchmarking to be an

important measure in preventing

significant increases in microbial risk

during implementation of the M-DBP

rule cluster. Moreover, States have

different statutory authorities governing

what they can mandate and some State

agencies are prohibited by State law

from adopting procedures not required

by federal regulations. Consequently,

EPA believes the inclusion of

benchmarking as a regulation is

warranted.

Commenters were concerned that the

benchmarking procedure would not take

into account source water

characteristics and that benchmarking

would not be accurate for systems

switching from one disinfectant to

another (e.g. chlorine to ozone). EPA

will cover both of these topics in the

Disinfection Benchmarking Guidance

Manual in sections that address setting

an alternative benchmark. Commenters

also asked EPA to provide instruction

on awarding disinfection credits taking

into account possible synergistic effects

for different sequential disinfectants.

However, as discussed in other parts of

this preamble, research in this area is

not adequate for a disinfection credit

scheme to be developed based on

synergistic inactivation.

Most comments submitted to EPA on

the issue of applicability favored using

80% of the MCLs for TTHM and HAA5

as threshold levels for profiling.

Commenters agreed with the EPA and

M-DBP Advisory Committee that these

values would capture most of the PWSs

likely to change their disinfection

processes to meet DBP MCLs. One

commenter proposed that using TTHM

and HAA5 data from two different years

would not present a problem because

either one of these parameters can

trigger the profiling requirement.

However, the majority of comments on

this subject supported requiring TTHM

and HAA5 data to be collected during

the same period since changes in water

quality and treatment conditions

influence not only the total quantity of

DBPs but also the relative formation of

different DBP species. In today’s rule

EPA requires that TTHM and HAA5

data used in determining applicability

be collected during the same period. A

few commenters recommended that the

applicability requirements for profiling

should also include ozonation systems

with bromate concentrations at least

80% of the MCL (i.e. 8μg/L). EPA has

elected not to include bromate levels in

the profiling requirements because

operational changes, such as dropping

the pH during ozonation, can decrease

bromate formation without reducing

disinfection efficacy.

Certain commenters felt that

disinfection profiling should only be

required in the event that a system

planned to change disinfection practice

and that requiring plants which meet

water quality standards to perform

additional studies is unwarranted. EPA

believes, however, that a profile should

span all seasons of at least one year to

show how seasonal variations impact

the log inactivation provided.

Consequently, waiting to profile until a

disinfection change is needed is not

practical because at least one year of

monitoring is required and this could

significantly delay the desired

modifications. Accordingly, EPA

maintains that profiling in advance of a

decision to change disinfection

practices will allow systems to comply

with TTHM and HAA5 MCLs in a

timely manner without increasing

microbial risk. For this reason, EPA

requires profiling of those PWSs most

like to modify their disinfection

procedures (i.e. those with TTHM and

HAA5 concentrations at or above 80%

of the MCLs).

Many comments advocated allowing

the use of grandfathered data in

developing disinfection profiles.

However, commenters were

predominantly against making the use

of existing operational data mandatory.

They expressed concern that such a

requirement would be inherently

inequitable, could entail significant

retrieval costs, and that the data might

not be representative of a system’s

current operations. EPA believes that

grandfathered data will often provide

the most accurate picture of historic

levels of microbial disinfection and

encourages its use in constructing the

disinfection profile. However, EPA

recognizes that certain problems, such

as those identified by commenters, may

justify the exclusion of grandfathered

data and, therefore, has made the use of

such data optional. EPA notes that

States may consider issues related to

profiling data when determining

whether a proposed change in

disinfection practice is acceptable.

The benchmarking procedure in

today’s rule, therefore, reflects the

concerns of commenters in many

respects. On issues such as the use of

grandfathered data, applicability

requirements, and evaluating proposed

changes in disinfection practice, the

disinfection benchmark requirements

conform to the majority view of

comments. In cases where the rule is at

variance with certain commenters’

suggestions, such as making the

disinfection benchmarking procedure

discretionary and requiring profiling

only in advance of a proposed change in

disinfection practice, EPA has acted in

accordance with the need to achieve

risk-risk balancing, which is a central

objective of the M–DBP rule cluster.

E. Definition of Ground Water Under

the Direct Influence of Surface Water

1. Today’s Rule

In today’s rule, EPA includes

Cryptosporidium in the definition of

ground water under the direct influence

of surface water (GWUDI). This change

in definition applies only to public

water systems that serve 10,000 or more

people.

2. Background and Analysis

EPA issued guidance in October 1992

as the Consensus Method for

Determining Groundwater Under the

Direct Influence of Surface Water Using

Microscopic Particulate Analysis (MPA).

As part of this method, a microscopic

examination is made of the ground

water to determine whether insect parts,

plant debris, rotifers, nematodes,

protozoa, and other material associated

with the surface or near surface

environment are present. Additional

guidance for making GWUDI

determinations is also available (EPA,

1994d, e). Since 1990, States have

acquired substantial experience in

making GWUDI determinations and

have documented their approaches

(Massachusetts Department of

Environmental Protection, 1993;

Maryland, 1993; Sonoma County Water

Agency, 1991). Guidance on existing

practices undertaken by States in

response to the SWTR may also be

found in the State Sanitary Survey

Resource Directory, jointly published in

December 1995 by EPA and the

Association of State Drinking Water

Administrators. AWWARF has also
69492 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

published guidance (Wilson et al.,

1996).

In the existing MPA guidance (EPA,

1992), Cryptosporidia oocysts are

included under the general category of

coccidian protozoans, a more

encompassing grouping, some of which

are pathogenic to humans. The score

assigned to an occurrence of a coccidian

is equivalent to the score assigned to an

occurrence of a Giardia cyst. Thus, it

not anticipated that any change is

needed in the MPA scoring

methodology to accommodate the

regulation of Cryptosporidium by this

rule.

The 1997 NODA summarized the

available guidance and additional

information provided by the States and

regulated community. Most recently,

Hancock et al. (1998) summarized some

of the available data on parasitic

protozoan occurrence in ground water

and EPA compiled additional data on

such occurrence in wells (SAIC, 1997a).

3. Summary of Major Comments

The July 29, 1994, Federal Register

notice proposed to amend the SWTR by

including Cryptosporidium in the

definition of a GWUDI system. Under

the 1994 IESWTR proposal, a system

using ground water considered

vulnerable to Cryptosporidium

contamination would be subject to the

provisions of the SWTR. EPA proposed

that this determination be made by the

State for individual sources using Stateestablished criteria. The 1994 proposed

IESWTR also requested comment on

revisions to EPA’s guidance on this

issue.

Commenters generally agreed that

Cryptosporidium should be added to the

definition.

F. Inclusion of Cryptosporidium in

Watershed Control Requirements

1. Today’s Rule

In today’s final rule, EPA is extending

the existing watershed control

regulatory requirements for unfiltered

systems serving 10,000 or more people

to include the control of

Cryptosporidium. Cryptosporidium will

be included in the watershed control

provisions for these systems wherever

Giardia lamblia is mentioned.

2. Background and Analysis

Watershed control requirements were

initially established in 1989 (EPA,

1989b, 54 FR 27496, June 29, 1989) as

one of a number of preconditions that a

public water system using surface water

must meet to avoid filtration. As part of

its 1994 IESWTR proposal (EPA, 1994b,

59 FR 38839, July 29, 1994), EPA

requested comment on extending these

existing watershed control requirements

for unfiltered systems at 40 CFR

141.71(b)(2) to include the control of

Cryptosporidium. This was intended to

be analogous to and build upon the

existing requirements for Giardia

lamblia and viruses; Cryptosporidium

would be included in the watershed

control provisions wherever Giardia

lamblia is mentioned. In the November

3, 1997 NODA (EPA, 1997a, 62 FR

59506), the Agency also requested

comment on issues pertaining to

monitoring for Giardia and

Cryptosporidium for unfiltered systems

serving 10,000 or more people.

As noted above, the SWTR specifies

the conditions under which a system

can avoid filtration (40 CFR 141.71).

These conditions include good source

water quality, as measured by

concentrations of coliforms and

turbidity; disinfection requirements;

watershed control; periodic on-site

inspections; the absence of waterborne

disease outbreaks; and compliance with

the Total Coliform Rule and the MCL for

TTHMs. This watershed control

program under the SWTR must include

a characterization of the watershed

hydrology characteristics, land

ownership, and activities which may

have an adverse effect on source water

quality, and must minimize the

potential for source water

contamination by Giardia lamblia and

viruses. The SWTR Guidance Manual

(EPA, 1991a) identifies both natural and

human-caused sources of contamination

to be controlled. These sources include

wild animal populations, wastewater

treatment plants, grazing animals,

feedlots, and recreational activities. The

Guidance Manual recommends that

grazing and sewage discharges not be

permitted within the watershed of

unfiltered systems, but indicates that

these activities may be permissible on a

case-by-case basis where there is a long

detention time and a high degree of

dilution between the point of activity

and the water intake. Although there are

no specific monitoring requirements in

the watershed protection program, the

non-filtering utility is required to

develop State-approved techniques to

eliminate or minimize the impact of

identified point and non-point sources

of pathogenic contamination. The

guidance already suggests identifying

sources of microbial contamination,

other than Giardia, transmitted by

animals, and points out specifically that

Cryptosporidium may be present if there

is grazing in the watershed.

As discussed in the 1997 IESWTR

NODA, the Seattle Water Department

summarized the Giardia and

Cryptosporidium monitoring results

from several unfiltered water systems

(Montgomery Watson, 1995). The

central tendency of this data is

approximately 1 oocyst/100L. In light of

data previously discussed that indicates

that at least 2-log removal of

Cryptosporidium is achievable with

filtration, and considering the Seattle

data analysis, it appears that unfiltered

water systems that comply with the

source water requirements of the SWTR

have a risk of cryptosporidiosis

equivalent to that of a water system with

a well-operated filter plant using a water

source of average quality. EPA plans to

continue to evaluate this issue when

additional data becomes available.

3. Summary of Major Comments

Commenters generally supported

specific inclusion of Cryptosporidium in

the watershed control requirements for

unfiltered systems. Some commenters

supported watershed control programs

in general without specifically offering

an opinion on Cryptosporidium. A few

commenters specifically opposed the

inclusion of Cryptosporidium in the

watershed control program, maintaining

that other avenues of watershed control

could be promoted without including

this organism in the control plan and

that environmental sources of Giardia

and Cryptosporidium were not

sufficiently understood.

In response, EPA believes that the

environmental sources of

Cryptosporidium are sufficiently

understood, as described above, to

support rule requirements.

Cryptosporidium cannot be easily

controlled with conventional

disinfection practices, and therefore its

presence in source water serving

unfiltered surface water systems must

be addressed. EPA also believes that

Cryptosporidium poses a potential

hazard to public health and, as noted

above, is establishing in today’s rule an

MCLG of zero for this pathogenic

protozoan. EPA is therefore amending

the existing watershed control

requirements for unfiltered systems to

include Cryptosporidium in order to

protect public health. EPA believes that

an effective watershed protection

program will help to improve source

water quality. Existing guidance already

references the need to guard against

pathogenic protozoa including

specifically Cryptosporidium. EPA is

proceeding on the presumption that

existing watershed programs already

consider and State reviews have

evaluated the adequacy of watershed

provisions to assure that raw drinking

water supplies are adequately protected

against Cryptosporidium contamination.
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69493

To the extent this is not the case,

however, EPA expects that unfiltered

systems, and States in their annual

review, will reassess their program with

regard to this concern and take whatever

steps are necessary to ensure that

potential vulnerability to

Cryptosporidium contamination is

considered and adequately addressed.

With regard to monitoring, many

NODA commenters supported some

form of routine monitoring for Giardia

and Cryptosporidium in unfiltered

watershed systems serving 10,000 or

more people. A few NODA commenters

supported event monitoring (i.e., an

occasion where the raw water turbidity

and/or fecal/total coliform

concentration exceeds a specific value

or possibly a site-specific 90th

percentile value) for large unfiltered

systems while others were silent on the

issue or against event monitoring. In

response, today’s final rule does not

include monitoring requirements for

unfiltered systems for several reasons.

The IFA method is the only method

currently and widely available to

evaluate the presence or absence of

Cryptosporidium in a water supply.

However, EPA does not believe this

method is appropriate for regulatory

compliance purposes because of its low

recovery and variability. EPA therefore

believes that monitoring is most

appropriately handled through guidance

at this time. EPA is working with

stakeholders to develop a guidance

document for unfiltered systems which

will describe possible monitoring

programs. Moreover, the Agency is

supporting and participating in the

development of improved

Cryptosporidium analytical methods,

including a draft interim method 1622.

At the moment, it is unclear when

prototype Cryptosporidium methods

(both method 1622, as well as methods

under development to determine

viability and infectivity) will be

adequate for regulatory use and

compliance determinations at low

concentration levels, but ongoing

research appears promising in this area.

As a result, establishment of

Cryptosporidium monitoring

requirements for unfiltered systems will

be considered during the development

of future microbial rules when EPA has

more information on which to base a

regulation (e.g. availability of better

methods, ICR monitoring data, and

research characterizing the relationship

between watershed control and

pathogen occurrence).

G. Covered Finished Water Reservoirs

1. Today’s Rule

In today’s final rule EPA is requiring

surface water and GWUDI systems that

serve 10,000 or more people to cover all

new reservoirs, holding tanks or other

storage facilities for finished water for

which construction begins after the

effective date of this rule, February 16,

1999. Today’s final rule does not apply

these requirements to existing

uncovered finished water reservoirs.

2. Background and Analysis

The proposed IESWTR (EPA, 1994b,

59 FR 38841) indicated that EPA was

considering whether to issue regulations

requiring systems to cover finished

water reservoirs and storage tanks, and

requested public comment. The

IESWTR Notice of Data Availability

(EPA, 1997a, 62 FR 59509) indicated

that EPA was considering a requirement

that systems cover all new reservoirs,

holding tanks or other storage facilities

for finished water for which

construction begins after the effective

date of the rule and invited comment on

this issue. The IESWTR NODA also

invited further comment on whether

there should be a requirement that all

finished water reservoirs, holding tanks

and other storage facilities be covered as

part of the development of future

regulations.

As discussed in the 1997 IESWTR

Notice of Data Availability, when a

finished water reservoir is open to the

atmosphere it may be subject to some of

the environmental factors that surface

water is subject to, depending upon sitespecific characteristics and the extent of

protection provided. Potential sources

of contamination to uncovered

reservoirs and tanks include airborne

chemicals, surface water runoff, animal

carcasses, animal or bird droppings and

growth of algae and other aquatic

organisms due to sunlight that results in

biomass (Bailey and Lippy, 1978). In

addition, uncovered reservoirs may be

subject to contamination by persons

tossing items into the reservoir or illegal

swimming (Pluntze 1974; Erb, 1989).

Increases in algal cells, heterotrophic

plate count (HPC) bacteria, turbidity,

color, particle counts, biomass and

decreases in chlorine residuals have

been reported (Pluntze, 1974, AWWA

Committee Report, 1983, Silverman et

al., 1983, LeChevallier et al. 1997a).

Small mammals, birds, fish, and the

growth of algae may contribute to the

microbial degradation of an open

finished water reservoir (Graczyk et al.,

1996a; Geldreich, 1990; Fayer and

Ungar, 1986; Current, 1986). In one

study, sea gulls contaminated a 10

million gallon reservoir and increased

bacteriological growth, and in another

study waterfowl were found to elevate

coliform levels in small recreational

lakes by twenty times their normal

levels (Morra, 1979). Algal growth

increases the biomass in the reservoir,

which reduces dissolved oxygen and

thereby increases the release of iron,

manganese, and nutrients from the

sediments. This, in turn, supports more

growth (Cooke and Carlson, 1989). In

addition, algae can cause drinking water

taste and odor problems as well as

impact water treatment processes.

EPA suggested in the proposal that

covering reservoirs and storage tanks

would reduce the potential for

contamination of the finished water by

pathogens and hazardous chemicals, as

well as limit the potential for taste and

odor problems and increased operation

and maintenance costs resulting from

algal blooms associated with

environmental factors such as sunlight.

Because of these concerns, EPA

guidelines recommend that all finished

water reservoirs and storage tanks be

covered (EPA, 1991a,b). The American

Water Works Association (AWWA) also

has issued a policy statement strongly

supporting the covering of reservoirs

that store potable water (AWWA, 1993).

In addition, a survey of nine States was

conducted in the summer of 1996

(Montgomery Watson, 1996). The States

which were surveyed included several

in the West (Oregon, Washington,

California, Idaho, Arizona, and Utah),

two States in the East known to have

water systems with open reservoirs

(New York and New Jersey), and one

midwestern State (Wisconsin). Seven of

the nine States which were surveyed

require by direct rule that all new

finished water reservoirs and tanks be

covered.

EPA is currently developing, with

stakeholder input, an Uncovered

Finished Water Reservoir Guidance

Document. The manual will discuss

methods to maintain water quality,

control aquatic and microbial growths,

describe methods to cover and line

reservoirs, and discuss the use of

sampling and sampling points to

monitor reservoir water quality.

3. Summary of Major Comments

Most commenters on the proposed

rule supported either federal or State

requirements for covered finished water

reservoirs. Some commenters on the

proposed rule suggested that regulations

apply only to new reservoirs while other

commenters opposed any requirement,

citing high cost, the notion that ‘‘one

size does not fit all,’’ and aesthetic

benefits of an open reservoir. Nearly all
69494 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

the commenters on the NODA

supported regulatory requirements for

covered finished water reservoirs in

order to protect human health. Many

commenters on the NODA supported

requirements for covered finished water

reservoirs for both new and existing

reservoirs. Some commenters on the

NODA supported requirements for new

reservoirs only to be covered and

believed that requirements for existing

uncovered reservoirs should be

included in a future regulation rather

than in today’s rule. Several

commenters on the NODA were against

a federal requirement for covered

finished reservoirs. One commenter

thought that EPA should provide States

with sufficient flexibility to make the

final decision on this issue while

another commenter suggested that any

future regulatory action for existing

reservoirs should take the form of

guidance to States. One commenter

believes that EPA does not have enough

information to require covered finished

reservoirs.

In response, EPA believes, in light of

the substantial information summarized

above, that microbial contamination

risks are posed by uncovered finished

water reservoirs and therefore is

requiring that all new reservoirs be

covered. The final rule requires that

finished water reservoirs for which

construction begins after the effective

date of today’s rule be built with covers.

With respect to existing reservoirs, EPA

needs more time to collect and analyze

additional information to evaluate

regulatory impacts on systems with

existing uncovered reservoirs on a

national basis. EPA needs this

information in order to carry out the

cost benefit analysis for a requirement

that existing reservoirs be covered. The

IESWTR therefore does not require that

existing reservoirs have covers installed.

EPA will further consider whether to

require the covering of existing

reservoirs during the development of

subsequent microbial regulations when

additional data and analysis to develop

the national costs of coverage are

available.

H. Sanitary Survey Requirements

1. Today’s Rule

The State must complete sanitary

surveys for all surface water and

GWUDI systems no less frequently than

every three years for community

systems and no less frequently than

every five years for noncommunity

systems. The State may ‘‘grandfather’’

sanitary surveys conducted after

December 1995 for the first set of

required sanitary surveys if the surveys

address the eight survey components of

the 1995 EPA/State guidance. The rule

also provides that for community

systems determined by the State to have

outstanding performance based on prior

sanitary surveys, successive sanitary

surveys may be conducted no less

frequently than every five years. In its

primacy application, the State must

include: (1) How it will decide whether

a system has outstanding performance

and is thus eligible for sanitary surveys

at a reduced frequency, and (2) how it

will decide whether a deficiency

identified during a survey is significant.

In the IESWTR, a sanitary survey is

defined as an onsite review of the water

source (identifying sources of

contamination using results of source

water assessments 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.

Components of a sanitary survey may

be completed as part of a staged or

phased State review process within the

established frequency interval set forth

below. A sanitary survey must address

each of the following eight elements:

Source; treatment; distribution system;

finished water storage; pumps, pump

facilities, and controls; monitoring and

reporting and data verification; system

management and operation; and

operator compliance with State

requirements. In addition, sanitary

surveys include review of disinfection

profiles for systems required to comply

with the disinfection benchmarking

requirements discussed elsewhere in

today’s notice.

States must have the appropriate rules

or other authority to assure that

facilities take the steps necessary to

address any significant deficiencies

identified in the survey report that are

within the control of the public water

system and its governing body. As noted

above, a State must also, as part of its

primary application, include how it will

decide; (1) Whether a system has

outstanding performance and is thus

eligible for sanitary surveys at a reduced

frequency, and (2) whether a deficiency

identified during a survey is significant

for the purposes of this rule. In addition,

a State must have appropriate rules or

other authority to ensure that a public

water system responds to significant

deficiencies outlined in a sanitary

survey report within 45 days of receipt

of the report, indicating how and on

what schedule the system will address

significant deficiencies noted in the

survey.

EPA notes that it will consider

sanitary surveys that meet IESWTR

requirements to also meet the

requirements for sanitary surveys under

the Total Coliform Rule (TCR), since the

definition of a sanitary survey under the

IESWTR is broader than that for the TCR

(i.e., a survey as defined under the

IESWTR includes all the elements, and

more, of a sanitary survey as required

under the TCR). Moreover, with regard

to TCR sanitary survey frequency, the

IESWTR requires that surveys be

conducted at least as frequently, or, in

some cases, possibly more often than

required under the TCR.

2. Background and Analysis

The July 29, 1994, Federal Register

proposed to amend the SWTR to require

periodic sanitary surveys for all public

water systems that use surface water, or

ground water under the direct influence

of surface water, regardless of whether

they filter or not. States would be

required to review the results of each

sanitary survey to determine whether

the existing monitoring and treatment

practices for that system are adequate,

and if not, what corrective measures are

needed to provide adequate drinking

water quality.

The July 1994 notice proposed that

only the State or an agent approved by

the State would be able to conduct the

required sanitary survey, except in the

unusual case where a State has not yet

implemented this requirement, i.e., the

State had neither performed the

required sanitary survey nor generated a

list of approved agents. The proposal

suggested that under exceptional

circumstances the sanitary survey could

be conducted by the public water

system with a report submitted to the

State within 90 days. EPA also

requested comment on whether sanitary

surveys should be required every three

or every five years.

In 1993, the Government Accounting

Office (GAO) issued a report

summarizing the findings of a survey

conducted to examine sanitary survey

programs as well as GAO’s key

observations (GAO, 1993). ‘‘On the basis

of a nationwide questionnaire and a

review of 200 sanitary surveys

conducted in four States (Illinois,

Montana, New Hampshire and

Tennessee), GAO found that sanitary

surveys are often deficient in how they

are conducted, documented and/or

interpreted.’’

The GAO survey found that 45 States

omit one or more of the key elements of

surveys that EPA recommends be

evaluated. The report also indicated

that, ‘‘regardless of a system’s size,
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69495

deficiencies previously disclosed

frequently went uncorrected.’’

In summary, GAO observed that

problems with sanitary survey programs

are compounded by the lack of any

minimum requirements on how surveys

are to be conducted and documented.

The GAO report notes that the result

‘‘has been that a key benefit of surveys—

identifying and correcting problems

before they become larger problems

affecting water quality— has often not

been realized.’’

Sanitary surveys have historically

been conducted by State drinking water

programs as a preventive tool to identify

water system deficiencies that could

pose a threat to public health. The

general requirements for State primacy

in § 142.10(b)(2) of subpart B include a

provision that the State have a

systematic program for conducting

sanitary surveys for public water

systems, with priority given to those

systems not in compliance with the

State’s primary drinking water

regulations. In addition, the TCR

includes regulatory requirements for

systems to have a periodic on-site

sanitary survey (54 FR 27544–27568, 29

June 1989). This rule requires all

systems that collect fewer than 5 total

coliform samples each month to

undergo such surveys. These sanitary

surveys must be conducted by the State

or an agent approved by the State.

Community water systems were to have

had the first sanitary survey conducted

by June 29, 1994, and every five years

thereafter while non-community water

systems are to have the first sanitary

survey conducted by June 29, 1999, and

every five years thereafter unless the

system is served by a protected and

disinfected ground water supply, in

which case, a survey must be conducted

every 10 years. The TCR does not

specify in detail what must be

addressed in a sanitary survey or how

such a survey should be conducted.

The SWTR does not specifically

require water systems to undergo a

sanitary survey. Instead, it requires that

unfiltered water systems, as one

criterion to remain unfiltered, have an

annual on-site inspection to assess the

system’s watershed control program and

disinfection treatment process. The onsite survey must be conducted by the

State or a party approved by the State.

This on-site survey is not a substitute

for a more comprehensive sanitary

survey, but the information can be used

to supplement a full sanitary survey.

EPA’s SWTR Guidance Manual (EPA,

1991a), Appendix K, suggests that, in

addition to the annual on-site

inspection, a sanitary survey be

conducted every three to five years by

both filtered and unfiltered systems.

This time period is suggested ‘‘since the

time and effort needed to conduct the

comprehensive survey makes it

impractical for it to be conducted

annually.’’

Since the publication of the proposed

ESWTR and GAO report, EPA and the

States (through the Association of State

Drinking Water Authorities) have issued

a joint guidance on sanitary surveys

entitled EPA/State Joint Guidance on

Sanitary Surveys (1995). The Guidance

outlines the following elements as

integral components of a comprehensive

sanitary survey:

• Source

—Protection

—Physical Components and

Condition

• Treatment

• Distribution System

• Finished Water Storage

• Pumps/Pump Facilities and

Controls

• Monitoring/Reporting/Data

Verification

• Water System Management/

Operations

• Operator Compliance with State

Requirements

The guidance also addresses the

qualifications for sanitary survey

inspectors, the development of

assessment criteria, documentation,

follow-up after the survey, tracking and

enforcement.

As discussed earlier, EPA published a

NODA (62 FR 59485) in November 1997

discussing new information the Agency

has received since the 1994 IESWTR

proposal as well as recommendations of

the M-DBP Advisory Committee. The

Advisory Committee made

recommendations on the definition and

frequency of surveys, as well as on

survey components based on the 1995

EPA/State Guidance, and follow-up

activities. In the 1997 Notice, EPA

requested comment on the Advisory

Committee recommendations. In

addition, the Agency requested

comment on whether systems should be

required to respond in writing to a

State’s sanitary survey report. EPA also

requested comment on (1) what would

constitute ‘‘outstanding performance’’

for purposes of allowing sanitary

surveys for a community water system

to be conducted every five years and (2)

how to define ‘‘significant deficiencies.’’

3. Summary of Major Comments

Commenters on the 1994 proposal

generally voiced support for requiring a

periodic sanitary survey for all systems.

One commenter suggested that EPA

develop sanitary survey guidance for

administration by the States, while

another commenter suggested that

sanitary surveys by the private sector be

certified by States or national

associations using EPA-defined criteria.

Commenters recommended that surveys

be conducted either by the State or a

private independent party/contractor.

One respondent contended that sanitary

surveys, as presently conducted, were

insufficient to assess operational

effectiveness in surface water systems.

With regard to sanitary survey

frequency, commenters on the 1994

proposal were nearly evenly divided

between every three years and every five

years. Some commenters argued that the

frequency should depend on: (1)

Whether a system’s control is effective

or marginal, (2) system size (less

frequent for small systems), (3) source

water quality, (4) whether the State

believes a system’s water quality is

likely to change over time, (5) results of

the previous survey, and (6) population

density on the watershed. One

commenter suggested an annual sanitary

survey.

In terms of the frequency of

conducting a sanitary survey,

commenters on the 1997 notice

generally voiced support for the

frequencies recommended by the M–

DBP Advisory Committee. One

commenter suggested that all public

water systems should have a sanitary

survey no less often than once every

three years and that systems with

unsatisfactory or provisional ratings

should be surveyed annually or more

often. Another commenter suggested

that even outstanding systems should be

surveyed on a three year cycle because

personnel or management changes can

impact plant performance. One

respondent recommended that sanitary

surveys be required at a maximum

frequency of every five years for all

public water systems using surface

water or ground water under the direct

influence of surface water as a source.

One commenter suggested that three

and five year schedules be given as

targets rather than requirements to allow

States flexibility in deploying resources.

EPA believes that the frequencies in

today’s rule allow States the flexibility

to prioritize and carry out the sanitary

survey process, while also ensuring that

these surveys will be conducted as an

effective preventive tool to identify and

correct water system deficiencies that

could pose a threat to public health.

Given these considerations and

recognizing that there are many more

non-community than community water

systems, EPA believes that the required

frequencies for sanitary surveys are

reasonable.
69496 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

With respect to the definition of

outstanding performance, most

commenters on the 1997 notice

suggested some combination of both a

history of no rule or public health

violations and past surveys without

significant deficiencies. One commenter

suggested that a system with no rule

violations in a year meeting 0.1 NTU

ninety-five percent of the time and

practicing filter to waste should get

some type of formal recognition from

EPA and be considered to have

outstanding performance. Another

respondent pointed out that in addition

to performance, other factors such as

management, emergency preparedness

and backup structures are critical to

maintain outstanding performance.

EPA believes that today’s rule

provides State flexibility to work within

their existing programs in addressing

how to define outstanding performance

and significant deficiencies as part of

their primacy application. The Agency

will discuss these issues in further

detail in Sanitary Survey Guidance

which is currently under development

with stakeholder input.

I. Compliance Schedules

1. Today’s rule

Today’s action establishes revised

compliance deadlines for States to adopt

and for public water systems to

implement the requirements in this

rulemaking. Central to the

determination of these deadlines are the

principles of simultaneous compliance

between the Stage 1 DBPR and the

corresponding rules (Interim Enhanced

Surface Water Treatment Rule, Long

Term Enhanced Surface Water

Treatment Rule, and Ground Water

Rule) to ensure continued microbial

protection, and minimization of riskrisk tradeoffs. These deadlines also

reflect new legislative provisions

enacted as part of 1996 SDWA

amendments. Section 1412 (b)(10) of the

SDWA as amended provides PWSs must

comply with new regulatory

requirements 36 months after

promulgation (unless EPA or a State

determines that an earlier time is

practicable or that additional time up to

two years is necessary for capital

improvements). In addition, section

1413(a)(1) provides that States have 24

instead of the previous 18 months from

promulgation to adopt new drinking

water standards.

Applying the 1996 SDWA

Amendments to today’s action, this

rulemaking provides that States have

two years from promulgation to adopt

and implement the requirements of this

regulation. Simultaneous compliance

will be achieved as follows.

Subpart H water systems that serve a

population of 10,000 or more generally

have three years from promulgation to

comply with all requirements of this

rule, except for profiling and

benchmarking, which require systems to

begin sampling after three months. In

cases where capital improvements are

needed to comply with the rule, States

may grant such systems up to an

additional two years to comply. These

deadlines were consistent with those for

the Stage 1 DBPR.

While only subpart H systems serving

at least 10,000 people are affected by

today’s rule, EPA has included

information on the compliance

requirements for other system categories

for the reader. Subpart H systems that

serve a population of less than 10,000

and all ground water systems will be

required to comply with applicable

Stage 1 DBPR requirements within five

years from promulgation. Since the

Long Term 1 Enhanced Surface Water

Treatment Rule (LT1) requirements that

apply to systems under 10,000 and the

Ground Water Rule (GWR) are

scheduled to be promulgated two years

after today’s rule or in November 2000,

the net result of this staggered deadline

is that these systems will be required to

comply with both Stage 1 DBPR and

LT1/GWR requirements three years after

promulgation of LT1/GWR at the same

end date of November 2003. For reasons

discussed in more detail below, EPA

believes this is both consistent with the

requirements of section 1412(b)(10) as

well as with legislative history affirming

the Reg. Neg. objectives of simultaneous

compliance and minimization of riskrisk tradeoff.

2. Background and Analysis

The background, factors, and

competing concerns that EPA

considered in developing the

compliance deadlines in today’s rule are

explained in detail in both the Agency’s

IESWTR and Stage 1 DBPR November

1997 NODAs. As explained in those

NODAs, EPA identified four options to

implement the requirements of the 1996

SDWA Amendments. The requirements

outlined above reflect the fourth option

that EPA requested comment upon in

November 1997.

By way of background, the SDWA

1996 Amendments affirmed several key

principles underlying the M–DBP

compliance strategy developed by EPA

and stakeholders as part of the 1992

regulatory negotiation process. First,

under section 1412(b)(5)(A), Congress

recognized the critical importance of

addressing risk/risk tradeoffs in

establishing drinking water standards

and gave EPA the authority to take such

risks into consideration in setting MCL

or treatment technique requirements.

The technical concerns and policy

objectives underlying M–DBP risk-risk

tradeoffs are referred to in the initial

sections of today’s rule and have

remained a key consideration in EPA’s

development of appropriate compliance

requirements. Second, Congress

explicitly adopted the phased M–DBP

regulatory development schedule

developed by the Negotiating

Committee. Section 1412(b)(2)(C)

requires that the M–DBP standard

setting intervals laid out in EPA’s

proposed ICR rule be maintained even

if promulgation of one of the M–DBP

rules is delayed. As explained in the

1997 NODA, this phased or staggered

regulatory schedule was specifically

designed as a tool to minimize risk/risk

tradeoff. A central component of this

approach was the concept of

‘‘simultaneous compliance’’, which

provides that a PWS must comply with

new microbial and DBP requirements at

the same time to assure that in meeting

a set of new requirements in one area,

a facility does not inadvertently increase

the risk (i.e., the risk ‘‘tradeoff’’) in the

other area.

A complicating factor that EPA took

into account in developing today’s

deadlines is that the SDWA 1996

Amendments changed two statutory

provisions that elements of the 1992

Negotiated Rulemaking Agreement were

based upon. The 1994 Stage 1 DBPR and

ICR proposals provided that 18 months

after promulgation large PWS would

comply with the rules and States would

adopt and implement the new

requirements. As noted above, Section

1412(b)(10) of the SDWA as amended

now provides that drinking water rules

shall become effective 36 months after

promulgation (unless the Administrator

determines that an earlier time is

practicable or that additional time for

capital improvements is necessary—up

to two years). In addition, section

1413(a)(1) now provides that States have

24 instead of the previous 18 months to

adopt new drinking water standards that

have been promulgated by EPA.

Today’s compliance deadline

requirements reflect the principle of

simultaneous compliance and the

concern with risk-risk tradeoffs. Subpart

H systems serving a population of at

least 10,000 will be required to comply

with the key provisions of this rule on

the same schedule as they will be

required to comply with the parallel

requirements of the accompanying Stage

1 DBPR that is also included in today’s

Federal Register.
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69497

With regard to subpart H systems

serving fewer than 10,000, EPA believes

that providing a five year compliance

period under Stage 1 DBPR is

appropriate and warranted under

section 1412(b)(10), which expressly

allows five years where necessary for

capital improvements. As discussed in

more detail in the 1997 IESWTR NODA,

capital improvements require, of

necessity, preliminary planning and

evaluation. An essential prerequisite of

such planning is a clear understanding

of final compliance requirements that

must be met. In the case of the staggered

M–DBP regulatory schedule established

as part of the 1996 SDWA Amendments,

LT1 microbial requirements for systems

under 10,000 are required to be

promulgated two years after the final

Stage 1 DBPR. As a result, small systems

will not even know what their final

combined compliance obligations are

until promulgation of the LT 1 rule.

Thus, an additional two year period

reflecting the two year Stage 1 DBPR/LT

1 regulatory development interval

established by Congress is required to

allow for the preliminary planning and

design steps which are inherent in any

capital improvement process.

In the case of ground water systems,

the statutory deadline for promulgation

of the GWR is May 2002. However, EPA

intends to promulgate this rule by

November 2000, in order to allow three

years for compliance and still ensure

simultaneous compliance by ground

water systems with the Stage 1 DBPR

and the GWR. As in the case of subpart

H systems serving fewer than 10,000,

system operators will not know until

November 2000 what the final

compliance requirements for both rules

are. EPA thus believes it appropriate to

grant the additional two years for

compliance with the Stage 1 DBPR

allowed by the statute.

EPA has been very successful in

meeting all of the new statutory

deadlines and is on track for the LT1

Rule and GWR. While EPA fully intends

to meet the schedule discussed earlier,

if those rules are delayed the Agency

will evaluate all available options to

protect against unacceptable risk-risk

trade-offs. Part of this effort is the

extensive outreach to systems already

underway to fully inform water supplies

of the likely elements in the upcoming

rules. In addition, EPA would consider

including provisions for streamlined

variance and/or exemption processing

in these rules if they were delayed, in

order to enhance State flexibility in

ensuring that compliance with the Stage

1 DBPR is not required before the

corresponding microbial protection rule.

Under today’s Stage 1 DBPR, EPA has

already provided small subpart H

systems and ground water systems the

two-year extension for capital

improvements since these systems will

not know with certainty until November

2000 if capital improvements will be

needed for simultaneous compliance

with the Stage 1 DBPR and LT1/GWR.

States considering whether to grant a

two-year capital improvement extension

for compliance with the GWR or LT1

will also need to consider the impact of

such extensions on compliance with

today’s rule, since the two-year

extension for the Stage 1 DBPR has

already been used. EPA believes,

however, that these systems will

generally not require extensive capital

improvements that take longer than

three years to install to meet Stage 1

DBPR, GWR, and LT1 requirements, or

will require no capital improvements at

all. However if needed, EPA will work

with States and utilities to address

systems that require time beyond

November 2003 to comply. This strategy

may include exemptions. In addition,

EPA will provide guidance and

technical assistance to States and

systems to facilitate timely compliance

with both DBP and microbial

requirements. EPA will request

comment on how best to do this when

the Agency proposes the LTESWTR and

GWR.

3. Summary of Major Comments

Commenters were in general

agreement that the compliance deadline

strategy contained in the fourth option

of the 1997 NODA did the best job of

complying with the requirements to

1996 SDWA Amendments and meeting

the objectives of the 1993 Reg. Neg.

Agreement that Congress affirmed as

part of the 1996 Amendments.

Nonetheless, a number of commenters

expressed concern about the ability of

large surface water systems that had to

make capital improvements to comply

with all requirements of the Stage 1

DBPR and IESWTR. They pointed out

that capital improvements include more

than just the construction, but also

financing, design, and approval.

EPA believes that the provisions of

section 1412(b)(10) of the SDWA as

amended allow systems the flexibility

needed to comply. As noted earlier in

this section, States may grant up to an

additional two years compliance time

for an individual system if capital

improvements are necessary. Moreover,

as both of these rules have been under

negotiation since 1992, proposed in

1994 and further clarified in 1997, EPA

believes that most systems have had

substantial time to consider how to

proceed with implementation and to

initiate preliminary planning. Several

commenters also supported delaying the

promulgation of the Stage 1 DBPR for

ground water systems until the GWR is

promulgated, in order to ensure

simultaneous compliance with both

rules. EPA believes that this option

would not be consistent with the regneg agreement, as endorsed by Congress,

because the agreement specifies that the

Stage 1 DBPR will apply to all

community and nontransient

noncommunity water systems.

Moreover, EPA has committed to the

LT1 and GWR promulgation schedule

outlined above precisely to address this

issue.

In conclusion EPA believes that the

compliance deadlines outlined above

for systems covered by this rule are

appropriate and consistent with the

requirements of the 1996 SDWA

amendments. The Agency notes,

however, that some elements of Option

4 outlined in the 1997 NODA apply to

systems that may be covered by future

Long Term Enhanced and Ground Water

rules. EPA intends to follow the

deadline strategy outlined in Option 4

for these future rules. However, as

today’s action only relates to the

IESWTR, the Agency will defer final

action on deadlines associated with

future rules until those rules,

themselves, are finalized.

IV. State Implementation

This section describes the regulations

and other procedures and policies States

have to adopt, or have in place, to

implement today’s final rule. States

must continue to meet all other

conditions of primacy in section 142.

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
69498 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

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 regulationspecific 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 final rule, along with the

special primacy requirements discussed

below.

To implement today’s final rule,

States are required to adopt revisions to

§ 141.2—definitions; § 141.32—public

notification; § 142.14—records kept by

States; § 142.15—reports by States;

§ 142.16—special primacy requirements;

§ 141.52—maximum contaminant level

goals for microbiological contaminants;

§ 141.70—general requirements;

§ 141.71—criteria for avoiding filtration;

§ 141.73—filtration; § 141.153—content

of the reports; and a new subpart P,

consisting of § 141.170 to § 141.175.

A. Special State Primacy Requirements

In addition to adopting drinking water

regulations at least as stringent as the

Federal regulations listed above, EPA

requires that States adopt certain

additional provisions related to this

regulation to have their program

revision application approved by EPA.

This information advises the regulated

community of State requirements and

helps EPA in its oversight of State

programs. States which require without

exception all public water systems using

a surface water source or a ground water

source under the direct influence of

surface water to provide filtration need

not demonstrate that the State program

has provisions that apply to systems

which do not provide filtration

treatment. However, such States must

provide the text of the State statutes or

regulations which specifies that public

water systems using a source water must

provide filtration.

EPA is currently developing, with

stakeholder input, several guidance

documents to aid the States and water

systems in implementing today’s final

rule. This includes guidance for the

following topics: Enhanced coagulation,

disinfection benchmark and profiling,

turbidity, alternative disinfectants, M–

DBP simultaneous compliance, sanitary

survey, unfiltered systems and

uncovered finished water reservoirs. In

addition, upon promulgation of the

IESWTR, EPA will work with States to

develop a State implementation

guidance manual.

To ensure that the State program

includes all the elements necessary for

a complete enforcement program, the

State’s application must include the

following in order to obtain EPA’s

approval for implementing this rule:

(1) Adoption of the promulgated

IESWTR.

(2) Description of how the State will

implement its sanitary survey program

and how the State will assure that a

system responds in writing to a sanitary

survey report within 45 days indicating

how and on what schedule the system

will address significant deficiencies

noted in the survey. The description

must also identify the appropriate rules

or other authority of the State to assure

that PWSs respond to significant

deficiencies. The State must conduct

sanitary surveys that include eight

specified components (described below)

for all surface water and GWUDI

systems no less frequently than every 3

years for community systems and no

less frequently than every five years for

noncommunity systems. The State may

‘‘grandfather’’ sanitary surveys

conducted after December 1995 for the

first set of required sanitary surveys if

the surveys address the eight sanitary

survey components (source; treatment;

distribution system; finished water

storage; pumps, pump facilities and

controls; monitoring and reporting and

data verification; system management

and operation; and operator compliance

with State requirements). For

community systems determined by the

State to have outstanding performance

based on prior sanitary surveys,

subsequent sanitary surveys may be

conducted no less than every five years.

The State must include how it will

decide whether a system has

outstanding performance in its primacy

application. Components of a sanitary

survey may be completed as part of a

staged or phased State review process

within the established frequency. The

State must also describe how it will

decide whether a deficiency identified

during a sanitary survey is significant.

(3) Description of the procedures the

State will use to determine the adequacy

of changes in disinfection process by

systems required to profile and

benchmark under § 141.172 and how

the State will consult with PWSs to

evaluate modifications to disinfection

practice.

(4) Description of existing or adoption

of appropriate rules or other authority to

assure PWSs to conduct a Composite

Correction Program (CCP) and to require

that PWSs implement any follow up

recommendations that results as part of

the CCP.

(5) Description of how the State will

approve a more representative annual

data set than the data set determined

under § 141.172(a)(1) or (2) for the

purpose of determining applicability of

the requirements of § 141.172

(disinfection benchmarking/profiling).

(6) Description of how the State will

approve a method to calculate the logs

of inactivation for viruses for a system

that uses either chloramines or ozone

for primary disinfection.

(7) For filtration technologies other

than conventional filtration treatment,

direct filtration, slow sand filtration or

diatomaceous earth filtration, a

description of how the State will

determine that a public water system

may use a filtration technology if the

PWS demonstrates to the State, using

pilot plant studies or other means, that

the alternative filtration technology, in

combination with the disinfection

treatment that meets the requirements of

§ 141.172(b) of this title, consistently

achieves 99.9 percent removal and/or

inactivation of Giardia lamblia cysts

and 99.99 percent removal and/or

inactivation of viruses, and 99 percent

removal of Cryptosporidium oocysts;

and a description of how, for the system

that makes this demonstration, the State

will set turbidity performance

requirements that the system must meet

95 percent of the time and that the

system may not exceed at any time at a

level that consistently achieves 99.9

percent removal and/or inactivation of

Giardia lamblia cysts, 99.99 percent

removal and/or inactivation of viruses,

and 99 percent removal of

Cryptosporidium oocysts.

B. State Recordkeeping Requirements

Today’s rule includes changes to the

existing record-keeping provisions to

implement the requirements in today’s

final rule. States must maintain records

of the following: (1) Turbidity

measurements must be kept for not less

than one year, (2) disinfectant residual

measurements and other parameters

necessary to document disinfection

effectiveness must be kept for not less

than one year, (3) decisions made on a

system-by-system basis and case-by-case

basis under provisions of part 141,

subpart H or subpart P, (4) a list of

systems consulting with the State

concerning a modification of

disinfection practice (including the

status of the consultation), (5) a list of

decisions that a system using alternative

filtration technologies can consistently

achieve a 99 percent removal of

Cryptosporidium oocysts as well as the

required levels of removal and/or
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69499

inactivation of Giardia and viruses for

systems using alternative filtration

technologies, including State-set

enforceable turbidity limits for each

system. A copy of the decision must be

kept until the decision is reversed or

revised and the State must provide a

copy of the decision to the system, (6)

a list of systems required to do filter

self-assessments, CPE or CCP. These

decision records must be kept for 40

years (as currently required by § 142.14

for other State decision records) or until

a subsequent determination is made,

whichever is shorter.

C. State Reporting Requirements

Currently States must report to EPA

information under 40 CFR 142.15

regarding violations, variances and

exemptions, enforcement actions and

general operations of State public water

supply programs. Today’s rule requires

States to provide additional information

to EPA within the context of the existing

special report requirements for the

SWTR (§ 142.15(c)(1)). States must

report a list of Subpart H systems that

have had a sanitary survey completed

during the previous year and an

evaluation of the State’s program for

conducting sanitary surveys.

D. Interim Primacy

On April 28, 1998, EPA amended its

State primacy regulations at 40 CFR

142.12 (EPA 1998d, 63 FR 23362) to

incorporate the new process identified

in the 1996 SDWA amendments for

granting primary enforcement authority

to States while their applications to

modify their primacy programs are

under review. The new process grants

interim primary enforcement authority

for a new or revised regulation during

the period in which EPA is making a

determination with regard to primacy

for that new or revised regulation. This

interim enforcement authority begins on

the date of the primacy application

submission or the effective date of the

new or revised State regulation,

whichever is later, and ends when EPA

makes a final determination. However,

this interim primacy authority is only

available to a State that has primacy for

every existing national primary drinking

water regulation in effect when the new

regulation is promulgated.

As a result, States that have primacy

for every existing NPDWR already in

effect may obtain interim primacy for

this rule, beginning on the date that the

State submits its complete and final

application for primacy for this rule to

EPA, or the effective date of its revised

regulations, whichever is later. In

addition, a State which wishes to obtain

interim primacy for future NPDWRs

must obtain primacy for this rule. After

the effective date of today’s rule, any

State that does not have primacy for this

rule cannot obtain interim primacy for

future rules.

V. Economic Analysis

A. Today’s Rule

EPA has estimated that the total

annualized cost for implementing the

IESWTR is $307 million, in 1998

dollars, at 7 percent rate cost of capital.

This estimate includes annualized

treatment costs to utilities ($192

million), start-up and annualized

monitoring costs to utilities ($99

million), and start-up and annualized

monitoring costs to States ($16 million).

Annualized treatment costs to utilities

includes annual operation and

maintenance costs ($106 million) and

annualized capital costs assuming 7

percent cost of capital ($86 million).

The two cost elements which have the

greatest impact on total annualized costs

are treatment ($192 million), which for

the most part reflects turbidity treatment

costs, and turbidity monitoring ($96

million). More detail including the basis

for these estimates and alternate cost

estimates using different cost of capital

assumptions are described later in this

section. The benefits resulting from this

rule range from $0.263 billion to $1.240

billion per year using a valuation of

$2,000 in health damages avoided per

cryptosporidiosis illness prevented

(based on the mean of a distribution of

values ascribed to health damages

avoided, as discussed below). Based on

this analysis, EPA has determined that

the benefits of today’s rule justify the

costs.

B. Overview of RIA for Proposed Rule

The Regulatory Impact Analysis (RIA)

(EPA, 1994f) for the proposed IESWTR

(59 FR 38832, July 29, 1994) only

considered one of the rule options that

were proposed: that which would

require systems to provide enough

treatment to achieve less than a 10¥4

risk level from giardiasis while meeting

the Stage 1 DBPR. Other rule options

were not considered for the RIA because

of insufficient data at the time of

proposal. The RIA for the proposed

1994 IESWTR estimated national capital

and annualized costs (amortized capital

and annual operating costs) for surface

water systems serving at least 10,000

people at $4.4 billion and $468 million

(in 1998 dollars at a 10% cost of capital)

respectively. In estimating these costs, it

was assumed that additional Giardia

reduction beyond the requirements of

the SWTR to achieve the 10¥4 risk level

would be achieved solely by using

chlorine as the disinfectant and

providing additional contact time by

increasing the disinfectant contact basin

size. Under the 1994 RIA, EPA also

estimated that 400,000 to 500,000

Giardia infections per year that could be

avoided would have an economic value

of $1.4 to $1.7 billion per year (in 1998

dollars at a 10% cost of capital),

suggesting under this rule option, the

benefit nationwide of avoiding Giardia

infections would be as much as three or

four times greater than the estimated

$468 million national annual cost of

providing additional contact time.

Development of the proposed rule

option was based on the availability of

an analytical method to quantify Giardia

source water concentrations and

prescribe appropriate levels of treatment

to achieve the 10¥4 risk level. This rule

option was dropped from consideration

of a final IESWTR since adequate

methods for measuring Giardia were not

available during the final development

phase of this rule. Also, ICR data was

not available to evaluate the validity of

assumed national Giardia source water

concentration levels under the RIA for

the proposed rule.

C. What’s Changed Since the Proposed

Rule

National source water occurrence data

for Giardia and Cryptosporidium are

being collected as part of the ICR but

this data will not become available until

after promulgation of the IESWTR.

Since February 1997, the Agency

worked with stakeholders to identify

additional data available since 1994 to

support the RIA for the IESWTR

published today. USEPA established the

Microbial and Disinfectants/

Disinfection Byproducts Advisory

Committee to collect, share and analyze

new information and data, as well as to

build consensus on the regulatory

implications of this new information.

D. Summary of Cost Analysis

The IESWTR will result in increased

costs to public water systems for

improved turbidity treatment,

monitoring, disinfection benchmarking

and covering new finished water

reservoirs, as well as State

implementation costs. As discussed

earlier in this Notice, the rule will only

apply to systems using surface water or

ground water under the direct influence

of surface water that serve 10,000 or

more persons. (EPA notes that the rule

does include provisions for primacy

States to conduct sanitary surveys for all

surface water and GWUDI systems

regardless of size.) EPA intends to

address systems serving less than 10,000

people, under the Long Term 1
69500 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

Enhanced Surface Water Treatment

Rule.

Table V.1 indicates estimated annual

costs associated with implementing the

IESWTR in 1998 dollars for different

cost of capital assumptions. A cost of

capital rate of 7 percent was used to

calculate the unit costs for the national

compliance cost model. This rate

represents the standard discount rate

preferred by the Office of Management

and Budget (OMB) for benefit-cost

analyses of government programs and

regulations. The 3 percent rate and 10

percent rate are provided as a sensitivity

analysis. The 10 percent rate also

provides a link to the 1994 Stage 1

DBPR cost analysis which was based on

a 10 percent rate.

Estimated costs are presented as

either public water system (utility) or

State costs. Utility costs include all

costs associated with improved

turbidity treatment, start-up and annual

costs for turbidity monitoring, the onetime cost of performing disinfection

benchmarking, and costs for covering

new finished water reservoirs. State

costs include program start-up and

ongoing implementation costs,

including sanitary surveys.

The 1994 proposal, in 1998 dollars, is

equivalent to $4.370 billion for total

capital costs, a difference of $3.611

billion (in 1998 dollars) from the capital

costs estimated for today’s final rule.

The difference is accounted for

primarily by rule criteria evaluated in

the benefit-cost analysis, i.e., changes in

the level of disinfection required. Under

the final IESWTR virtually no systems

would need to install additional

disinfection contact basins. Also, the

capital costs associated with physical

removal under the final IESWTR are

substantially lower than those estimated

in the 1994 RIA.

To comply with the IESWTR, systems

would be expected to employ treatment

enhancement and/or modifications.

These activities were grouped into 10

decision tree categories based on general

process descriptions as follows:

chemical addition, coagulant

improvements, rapid mixing,

flocculation improvements, settling

improvements, filtration improvements,

hydraulic improvements, administration

culture improvements, laboratory

modifications and process control

testing modifications. Descriptions of

how systems were expected to evaluate

these activities are included in the

document Technologies and Costs for

the Interim Enhanced Surface Water

Treatment Rule (USEPA, 1998b).

The decision tree stratifies public

water systems into groups or categories

based on the number of people served

and the range of treatment choices

available to them to achieve

compliance. The decision tree

incorporates estimates of the percent of

public water systems in each category

selecting a particular approach to

achieve compliance. These percentages

were factors in the national cost model

and represent the percentage of systems

needing to modify treatment to meet the

limits. Further description of the

compliance decision tree and

methodology are included in the

Regulatory Impact Analysis for the

Interim Enhanced Surface Water

Treatment Rule (USEPA, 1998a). Based

on this decision tree analysis and the

total costs indicated in Table V.1, the

two cost elements which have the

greatest impact on national costs are

Total Treatment, which for the most

part reflects turbidity treatment costs,

and Turbidity Monitoring. The percent

of systems estimated to modify

treatment practices to meet the revised

turbidity requirements (i.e., 0.3 NTU 95

percentile and 1 NTU maximum

combined filter effluent levels) is 50

percent (or 691 out of a possible 1,381

systems), as shown in Table V.2.

Turbidity monitoring is required of all

systems covered by the rule and using

rapid granular filtration (i.e.,

conventional or direct filtration). As

shown in table V.3, total annual cost to

utilities for turbidity monitoring are $96

million.

E. Household Costs

Household costs are a way to

represent water system treatment costs

as costs to the system customer. Under

the IESWTR, households will face the

increases in annual costs displayed in

Figure V.1. All households served by

large surface water systems will incur

additional costs under the IESWTR

since all systems are required to perform

turbidity monitoring activities.

However, as shown in the cumulative

distribution of households affected by

the rule, 92 percent of households (60

million) will incur less than a cost of $1

per month. 7 percent of households (5

million) will face an increase in cost of

between $1 and $5 per month. The

highest cost faced by 23,000 households

is approximately $100 per year ($8 per

month).

The assumptions and structure of this

analysis, in describing the curve, tend to

overestimate the highest costs. To be on

the upper bound of the curve, a system

would have to implement all, or almost

all, of the treatment activities. These

systems, however, might seek less costly

alternatives, such as connecting into a

larger regional water system.

F. Summary of Benefits Analysis

The economic benefits of the IESWTR

derive from the increased level of

protection to public health. The primary

goal of these provisions is to improve

public health by increasing the level of

protection from exposure to

Cryptosporidium and other pathogens

(i.e., Giardia, or other waterborne

bacterial or viral pathogens) in drinking

water supplies through improvements

in filtration at water systems. The

IESWTR is expected to reduce the level

of Cryptosporidium and other pathogen

contamination in finished drinking

water supplies through improvements

in filtration at water systems (i.e.,

revised turbidity requirements). In this

case, benefits will accrue due to the

decreased likelihood of endemic

incidences of cryptosporidiosis,

giardiasis and other waterborne disease,

and the avoidance of resulting health

costs. In addition to reducing the

endemic disease, the provisions are

expected to reduce the likelihood of the

occurrence of Cryptosporidium

outbreaks and their associated economic

costs, by providing a larger margin of

safety against such outbreaks for some

systems.

The benefit analysis attempts to take

into account some of the uncertainties

in the analysis by estimating benefits

under two different current treatment

assumptions and three improved

removal assumptions. The benefit

analysis also used Monte Carlo

simulations to derive a distribution of

estimates, rather than a single point

estimate.

The benefits analysis focused on

estimating changes in incidence of

cryptosporidiosis that would result from

the rule. The analysis included

estimating the baseline (pre-IESWTR)

levels of exposure from

Cryptosporidium in drinking water,

reductions in such exposure resulting

from treatment changes to comply with

the IESWTR, and resultant reductions of

risk.

Baseline levels of Cryptosporidium in

finished water were estimated by

assuming national source water

occurrence distribution (based on data

by LeChevallier and Norton 1995) and a

national distribution of

Cryptosporidium removal by treatment.

In the IESWTR RIA, the following two

assumptions were made about the

performance of current treatment in

removing oocysts to estimate finished

water Cryptosporidium concentrations.

Based on treatment removal efficiency

data presented in the 1997 IESWTR

NODA, EPA assumed a national

distribution of physical removal
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69501

efficiencies with a mean of 2.5 logs and

a standard deviation of ±0.63 logs.

Under this assumption, average log

removal for different plants would

generally range from 1.25 logs to 3.75

logs. Because the finished water

concentrations of oocysts represent the

baseline against which improved

removal from the IESWTR is compared,

variations in the log removal

assumption could have considerable

impact on the risk assessment. To

evaluate the impact of the removal

assumptions on the baseline and

resulting improvements, an alternative

mean log removal/inactivation

assumption of 3.0 logs and a standard

deviation of ±0.63 logs was also used to

calculate finished water concentrations

of Cryptosporidium. Under this

assumption average log removal for

different plants would generally range

from 1.75 to 4.25 logs.

For each of the two baseline

assumptions, USEPA assumed that a

certain number of plants would show

low, mid or high improved removal,

depending upon factors such as water

matrix conditions, filtered water

turbidity effluent levels, and coagulant

treatment conditions. As a result, the

RIA considers six scenarios that

encompass the range of endemic health

damages avoided based on the rule.

The finished water Cryptosporidium

distributions that would result from

additional log removal with the

turbidity provisions were derived

assuming that additional log removal

was dependent on current removal, i.e.,

that sites currently operating at the

highest filtered water turbidity levels

would show the largest improvements

or high improved removal assumption

(e.g., plants now failing to meet a 0.4

NTU limit would show greater removal

improvements than plants now meeting

a 0.3 NTU limit).

Table V.4 indicates estimated annual

benefits associated with implementing

the IESWTR. The benefits analysis

quantitatively examines endemic health

damages avoided based on the IESWTR

for each of the six scenarios mentioned

above. For each of these scenarios, EPA

calculated the mean of the distribution

of the number of illnesses avoided. The

assessment also discusses, but does not

quantify, other economic benefits that

may result from the provisions,

including the avoided health damage

costs associated with reduced risk of

outbreaks and avoided costs of averting

behavior such as boiling water or use of

an alternative water source during

outbreaks or periods of high turbidity.

According to the RIA performed for

the IESWTR published today, the rule is

estimated to reduce the mean annual

number of illnesses caused by

Cryptosporidium in water systems

improving filtration by 110,000 to

463,000 cases depending upon which of

the six baseline and improved

Cryptosporidium removal assumptions

was used. Based on these values, the

mean estimated annual benefits of

reducing the illnesses ranges from

$0.263 billion to $1.240 billion per year.

This calculation is based on a valuation

of $2,000 per incidence of

cryptosporidiosis prevented which is

the mean of a distribution of values

ascribed to health damages avoided. The

RIA also indicated that the rule could

result in a mean reduction of 14 to 64

fatalities each year, depending upon the

varied baseline and improved removal

assumptions. Using a mean value of

$5.6 million per statistical life saved,

reducing these fatalities could produce

benefits in the range of $0.085 billion to

$0.363 billion.

G. Comparison of Costs and Benefits

Given the costs summarized in Table

V.1 and the benefits summarized in

Table V.4, the IESWTR results in

positive net benefits under all three

improved removal scenarios (low, mid,

and high) assuming that current

treatment as a national average achieves

2.5 log of Cryptosporidium removal,

taking into account only the value of

cost of illness avoided. Using a current

national average treatment removal

assumption of 3.0 logs, net benefits are

positive under the high and mid

improved removal scenarios. Net

benefits using the 3.0 log current

removal assumption are negative under

the low improved removal scenario

using only the value of cost of illness

avoided, however, when the value of

mortalities prevented is added into the

benefits, all scenarios have positive net

benefits at the mean.

Thus, the monetized net benefits are

positive across most of the range of

current treatment assumptions,

improved log removal scenarios, and

discount rates. The benefits due to the

illnesses avoided may be slightly

overstated when aggregated with

benefits due to mortalities avoided,

because the mortalities were not netted

out of the number of illnesses. This

value is minimal and would not be

captured at the level of significance of

the analysis. Several categories of

benefits, including reducing the risk of

outbreaks, reducing exposure to other

pathogens such as Giardia, and avoiding

the cost of averting behavior have not

been quantified for this analysis, but

could represent substantial additional

economic value. In addition, the

estimates for avoided costs of illness do

not include the value for pain and

suffering or the risk premium.

TABLE V.1.—ANNUAL COSTS OF THE INTERIM ENHANCED SURFACE WATER TREATMENT RULE ($000S)

Final Rule (1998 dollars) 1994 Proposal

3% Cost of

Capital

7% Cost of

Capital

10% Cost of

Capital

10% Cost of

Capital

1992 dollars

10% Cost of

Capital

1998 dollars

Utility Costs

Utility Treatment Capital .................................................................... $758,965 $758,965 $758,965 $3,665,568 $4,370,389

Annual Costs

Annualized Capital † .......................................................................... 65,999 85,611 103,437

Annual O&M ...................................................................................... 105,943 105,943 105,943

Total Treatment ................................................................................. 171,942 191,554 209,380 391,702 466,891

Turbidity Monitoring ........................................................................... 95,924 95,924 95,924

Turbidity Exceptions* ......................................................................... 195 195 195

Disinfection Benchmarking ................................................................ 2,841 2,841 2,841

Subtotal ...................................................................................... 270,902 290,514 308,340 391,702 466,891

Annualized One-Time Costs**

Turbidity Monitoring Start-Up ............................................................ 289 405 504 .................... ....................
69502 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

TABLE V.1.—ANNUAL COSTS OF THE INTERIM ENHANCED SURFACE WATER TREATMENT RULE ($000S)—Continued

Final Rule (1998 dollars) 1994 Proposal

3% Cost of

Capital

7% Cost of

Capital

10% Cost of

Capital

10% Cost of

Capital

1992 dollars

10% Cost of

Capital

1998 dollars

HAA Benchmarking ........................................................................... 175 246 306 .................... ....................

Subtotal ...................................................................................... 464 651 810 .................... ....................

Total Annual Utility Costs .................................................... 271,366 291,165 309,150 .................... ....................

State Costs

Annual Costs

Turbidity Monitoring ........................................................................... 5,256 5,256 5,256 .................... ....................

Turbidity Exceptions*** ...................................................................... 409 409 409 .................... ....................

Sanitary Survey ................................................................................. 6,979 6,979 6,979 867 1,034

Disinfection Benchmarking ................................................................ 2,789 2,789 2,789 .................... ....................

Subtotal ...................................................................................... 15,433 15,433 15,433 867 1,034

Annualized One-Time Costs**

Turbidity Monitoring Start-Up ............................................................ 27 38 48 .................... ....................

Disinfection Benchmarking Start-Up ................................................. 22 30 38 .................... ....................

Sanitary Survey Start-Up ................................................................... 39 55 69 .................... ....................

Subtotal ...................................................................................... 88 123 155 .................... ....................

Total Annual State Costs .................................................... 15,521 15,556 15,588 .................... ....................

Total Annual Costs .............................................................. 286,887 306,721 324,738 392,569 467,925

* Costs associated with Individual Filter Effluent Turbidity Requirements for exceptions reporting, Individual Filter Assessments.

**All one-time costs are annualized over 20 years.

*** Costs associated with Reporting Exceptions and Comprehensive Performance Evaluations.

† Most costs are annualized over 20 years. Some costs, including turbidimeters and process control monitoring, are annualized over 7 years.

TABLE V.2.—FINAL ANNUAL COST ESTIMATES FOR TURBIDITY TREATMENT REQUIREMENTS

[0.3 NTU CFE 95th percentile, 1 NTU CFE Maximum 1998 $000s]

System Size (population served) Number of

Systems

Systems

Modifying

Treatment

3 Percent

Cost of

Capital

7 Percent

Cost of

Capital

10 Percent

Cost of

Capital

10,000–25,000 .......................................................................................... 594 303 $ 33,946 $ 37,624 $40,932

25,000–50,000 316 161 29,316 31,862 35,304

50,000–75,000 .......................................................................................... 124 63 15,450 17,143 18,564

75,000–100,000 ........................................................................................ 52 27 7,958 8,861 9,508

100,000–500,000 ...................................................................................... 259 122 56,895 63,544 69,080

500,000–1 Million ...................................................................................... 26 11 16,310 18,381 20,092

>1 Million .................................................................................................. 10 4 10,130 11,641 12,927

Total ................................................................................................... 1,381 691 170,005 189,056 206,407

TABLE V.3.—UTILITY TURBIDITY START-UP AND MONITORING ANNUAL COSTS

Compliance Activities Respondents Affected Unit Costs CF * Annual Costs

Utility Start-Up Costs ** .............................................. 1,381 Systems ..................................... $3,108 0.09439 $405,136

Utility Plant Monitoring Costs .................................... 1,728 Plants ......................................... 52,644 90,968,832

Utility System Monitoring Costs ................................. 1,381 Systems ..................................... 3,588 4,955,028

Total Annual Utility Costs for Turbidity Monitoring and Start-Up.......................................................... 96,328,996

* The Capitalization Factor (CF) is calculated using the cost of capital (7%), the number of years of capitalization (20 years), and the current

value of money ($1).

**Start-up costs are annualized over 20 years with a CF of 0.09439.
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69503

TABLE V.4.—SUMMARY OF POTENTIAL ANNUAL BENEFITS

Baseline Assumes

2.5 Log Cryptosporidium Removal 3.0 Log Cryptosporidium Removal

Mean Range Mean Range

Cryptosporidiosis Illness

Avoided Annually

Low Estimate of Number of

Illnesses Avoided.

338,000 .......................... 0–1,029,000 ................... 110,000 .......................... 0–322,500

Cost of Illness Avoided .. $0.950 billion .................. 0–1.883 billion ................ 0.263 billion .................... 0–0.585 billion

Mid Number of Illnesses

Avoided.

432,000 .......................... 0–1,074,000 ................... 141,000 .......................... 0–333,000

Cost of Illness Avoided .. 1.172 billion .................... 0–1.960 billion ................ 0.327 billion .................... 0–0.608 billion

High Number of Illnesses

Avoided.

463,000 .......................... 0–1,080,000 ................... 152,000 .......................... 0–338,000

Cost of Illness Avoided .. 1.240 billion .................... 0–1.999 billion ................ 0.359 billion .................... 0–0.620 billion

Value of Cryptosporidiosis

Mortalities Avoided Annually

Low Number of Mortalities

Avoided.

48 ................................... 0–129 ............................. 14 ................................... 0–40

Value of Mortalities

Avoided.

0.272 billion .................... 0–0.674 billion ................ 0.085 billion .................... 0–0.209 billion

Mid Number of Mortalities

Avoided.

60 ................................... 0–135 ............................. 18 ................................... 0–42

Value of Mortalities

Avoided.

0.341 billion .................... 0–0.706 billion ................ 0.107 billion .................... 0–0.219 billion

High Number of Mortalities

Avoided.

64 ................................... 0–136 ............................. 20 ................................... 0–42

Value of Mortalities

Avoided.

0.363 billion .................... 0–0.708 billion ................ 0.115 billion .................... 0–0.221 billion

Reduced Risk of

Cryptosporidiosis Outbreaks

Cost of Illness Avoided

Emergency Expenditures

Liability Costs Benefits not quantified, but could be substantial for large outbreak ($0.800 billion cost of illness avoided for a

Milwaukee-level outbreak).

Reduced Risk from Other

Pathogens.

Benefits not quantified.

Enhanced Aesthetic Water

Quality.

Difference may not be noticeable to consumer.

Averting Behavior ...................... Benefits not quantified, but could be substantial for large outbreak ($0.020 billion to $0.062 billion for a Milwaukee-level outbreak).

BILLING CODE 6560–50–P
69504 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

BILLING CODE 6560–50–C

VI. Additional Issues Discussed in 1994

Proposal and 1997 NODA

A. Inactivation of Cryptosporidium

When the IESWTR was proposed in

1994, EPA recognized that chlorine

disinfectants were relatively ineffective

in inactivating Cryptosporidium, but

was not certain if alternative

disinfectants might be more effective

than chlorine. In the NODA for the

IESWTR, EPA discussed the present

data on Cryptosporidium disinfection

for a variety of disinfectants. Many

commenters thought that sufficient data

was not available to develop guidelines

for estimating inactivation of

Cryptosporidium in water. Several

commenters pointed out the

inconsistency of inactivation data from

different studies. Some commenters also

supported the use of Giardia as the

target organism for defining the

disinfection benchmark required by

today’s rule. EPA believes that

variability in inactivation results is not

surprising, given the absence of

standard testing protocol and

methodology, and agrees that the

existing data is not sufficient to enable

the development of guidelines for

estimating inactivation efficiencies for

Cryptosporidium in water. The Agency

also notes that research is underway to

better clarify inactivation efficiencies for

Cryptosporidium and anticipates that

new research results will be available

for consideration during the

development of the Long Term 2

Enhanced Surface Water Treatment Rule

which EPA plans to promulgate

simultaneously with the Stage 2 DBPR.

B. Giardia Inactivation CT Values for

Profiling/Benchmarking

In the 1997 NODA for the IESWTR,

EPA requested comment on developing

CT tables for free chlorine at pH levels

above 9, which are not currently

available in EPA’s guidance to the

SWTR. This effort was intended to

support implementation of the

microbial profiling/benchmarking

required in the today’s rule. Under the

profiling/benchmarking requirement,

certain utilities must determine CT

values and compute daily average log

inactivation of Giardia.

While some commenters supported

the CT tables for high pHs presented in

the NODA, other commenters opposed

them because they thought that the

literature data were not sufficient for

development of these CT tables.

Commenters also noted that for the

systems with pH levels higher than 9,

States currently provide guidelines by

which utilities can estimate inactivation

levels for the purpose of compliance

with the SWTR. State guidelines are to

use inactivation levels at pH 9 for above

pH 9 conditions. EPA believes these

guidelines, along with existing CT

tables, are sufficient for implementing

the benchmark/profiling requirements

and therefore no additional CT tables

have been developed at this time.

As explained previously, in

conjunction with today’s rule, EPA is

also concurrently promulgating the

Stage 1 DBPR under which the

maximum disinfectant residual level for

free chlorine is 4 mg/L. However, the CT

tables for free chlorine that appear in

the SWTR Guidance Manual only cover

the chlorine residual up to 3 mg/L.

Some commenters expressed a need for

CT values for higher chlorine residuals.

Since it has been observed that the free

chlorine residual concentration (C) is

not as significant as the contact time (T)

in terms of inactivation kinetics for

Giardia cysts and no data are currently

available to support the development of

additional CT tables for the range of

chlorine residuals between 3 and 4 mg/

L, EPA recommends that for the purpose

of microbial profiling/benchmarking the

value of 3 mg/L as Cl2 be used for

estimating log inactivation when the

chlorine residual level is higher than 3

mg/L.

C. Cross Connection Control

Today’s Rule

EPA is not establishing requirements

for cross connection control in today’s

final rule. The Agency does plan to

consider cross connection control issues

during the development of subsequent

microbial regulations, in the context of

a broad range of issues related to

distribution systems. At that time the

results of research currently in progress

should be available to the Agency and

enable EPA to make regulatory

decisions.

Background and Analysis

The proposed IESWTR (EPA, 1994b,

59 FR 38841, July 29, 1994) requested
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69505

public comment on whether the Agency

should require States and/or systems to

have a cross-connection control

program. In addition, the Agency

solicited comment on a number of

associated issues, including (1) what

specific criteria, if any, should be

included in such a requirement, (2) how

often such a program should be

evaluated, (3) whether EPA should limit

any requirement to only those

connections identified as a cross

connection by the public water system

or the State, and (4) conditions under

which a waiver from this requirement

would be appropriate. The Agency also

requested commenters to identify other

regulatory measures EPA should

consider to prevent contamination of

drinking water in the distribution

system (e.g., minimum pressure

requirements in the distribution

system).

Historically, a significant portion of

waterborne disease outbreaks reported

by CDC are caused by distribution

system deficiencies. Distribution system

deficiencies are defined in CDC’s

publication Morbidity and Mortality

Weekly Report as cross connections,

contamination of water mains during

construction or repair, and

contamination of a storage facility.

Between 1971–1994, approximately 53

waterborne disease outbreaks reported

were associated with cross connections

or backsiphonage. Fifty-six outbreaks

were associated with other distribution

system deficiencies (Craun, Pers. Comm.

1997b). Some outbreaks have resulted

from water main breaks or repairs.

There is no centralized repository

where backflow incidents are reported

or recorded. The vast majority of

backflow incidents are probably not

reported. Examples of specific backflow

incidents are described in detail in

EPA’s Cross-Connection Control Manual

(EPA, 1989a).

Where cross connections exist, some

protection is still afforded to the

distribution system by the maintenance

of a positive water pressure in the

system. Adequate maintenance of

pressure provides a net movement of

water out through breaks in the

distribution pipes and prevents

contaminated water outside of the pipes

from entering the drinking water

supply. The loss of pressure in the

distribution system, less than 20 psi,

can cause a net movement of water from

outside the pipe to the inside, possibly

allowing the introduction of fecal

contamination into the system. This

problem is of special concern where

wastewater piping is laid in the same

street as the water pipes, creating a

potential threat to public health

whenever there is low or no pressure.

A number of States have cross

connection control programs, although

the extent to which they vary is unclear.

A Florida Department of Environmental

Protection survey evaluated crossconnection control regulations in the 50

States (Florida DEP 1996). The survey

results showed that 29 of the 40 States

that responded to the survey request

have programs. The rigor of the

programs and the extent to which they

are enforced was not addressed by the

survey. An EPA report suggests that the

responsibility for administration and

enforcement of the State programs is

generally at the local level (EPA, 1995a).

Summary of Major Comments

Most commenters supported either a

federal or State cross connection control

program in order to prevent disease

outbreaks and injury to the public.

Some commenters suggested EPA

update its guidance document on cross

connection control. Commenters

opposed to a cross connection control

program indicated that (1) a federallymandated program would be

impractical, burdensome, and would

fail, (2) a State or local program would

be more appropriate than an EPAmandated program, (3) most States

already have a comprehensive program,

thus negating need for federal

regulations, (4) EPA should publish

general guidelines only, and (5) there

should be a separate regulation because

a cross connection control program

would affect both surface water and

ground water.

As noted above, EPA plans to

consider cross connection control in the

context of future microbial rules rather

than in the IESWTR. The Agency will

consider cross connection control issues

in connection with a broad range of

issues related to distribution systems as

it develops these microbial rules. Issues

to be considered include biofilm growth

and the potential for biofilm associated

with pathogens, water treatment and

distribution system operations to

minimize microbial growth, and causes

of pathogen intrusion into the

distribution system. These are all areas

that are the focus of a significant

research effort, most of which is still in

progress. The American Water Works

Association Research Foundation

(AWWARF) presently has 17 projects

pertaining to maintenance of water

quality in the distribution system that

are not yet complete. EPA’s laboratories

are also working on important research

questions in these areas. EPA intends to

evaluate this large body of distribution

system research as well as data on State

and local government requirements and

their impact in order to develop

comprehensive regulations and

guidance on distribution system

maintenance and operations, including

the prevention of cross-connections.

EPA has previously published

guidance on cross connection control

entitled the Cross Connection Control

Manual (EPA, 1989a, EPA 570/9–89–

007, June 1989). This guidance

describes methods, devices, etc. for

prevention of backflow and backsiphonage, testing procedures for

backflow preventers, administration of

cross-connection programs and crossconnection control ordinance

provisions. The Agency plans to update

this Cross Connection Control Manual

during the development of future

microbial rules that address cross

connection. The Agency will request

public comment on issues related to

cross connection control at that time.

EPA would also like to point out that a

number of States and local governments

have existing cross connection control

programs and strongly encourages States

and local governments to implement

effective cross connection control

programs.

D. Filter Backwash Recycling

The SDWA Amendments of 1996

require that the EPA promulgate a

regulation governing the recycle of filter

backwash water within the treatment

process by August 2000. The Agency is

currently developing data and collecting

information to consider these issues in

a separate rule rather than in the

IESWTR. The Agency held a public

meeting in Denver, Colorado, in July

1998 and plans to hold another meeting

in early 1999 to discuss available data

and possible regulatory options, and

intends to propose a rule in August of

1999.

E. Certification Criteria for Water Plant

Operators

The July 29, 1994 notice requested

comment on whether the ESWTR

should define minimum certification

criteria for surface water treatment plant

operators. Currently, the SWTR (141.70)

requires such systems to be operated by

‘‘qualified personnel who meet the

requirements specified by the State’’.

EPA is not further defining ‘‘qualified’’

in the IESWTR as the operator

certification requirements discussed

below will address this issue. The 1996

Amendments to the SDWA direct the

Administrator, EPA, in cooperation with

the States, to publish guidelines in the

Federal Register specifying minimum

standards for certification and

recertification of operators of
69506 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

community and nontransient

noncommunity public water systems.

Draft guidelines were published in the

Federal Register Friday, March 27, 1998

(EPA 1998f) with a 90-day public

comment period. Final guidelines are

required to be published by February

1999. States then have two years to

adopt and implement an operator

certification program that meets these

guidelines. After that date, if a State has

not adopted and implemented an

approved program, the Administrator

must withhold 20 percent of the funds

a State is otherwise entitled to receive

in its Drinking Water State Revolving

Fund (DWSRF) capitalization grants

under section 1452 of SDWA. Questions

regarding the draft guidelines may be

directed to Jenny Jacobs (202–260–2939)

or Richard Naylor (202–260–5135) of

EPA’s Office of Ground Water and

Drinking Water. Their e-mail addresses

are: jacobs.jenny@epamail.epa.gov and

naylor.richard@epamail.epa.gov. In light

of the 1996 Amendments and the draft

guidelines, certification criteria need

not be included in today’s rule.

VII. Other Requirements

A. Regulatory Flexibility Act

Under the Regulatory Flexibility Act

(RFA), 5 U.S.C. 601 et seq., as amended

by the Small Business Regulatory

Enforcement Fairness Act of 1996, EPA

is generally required to prepare a

regulatory flexibility analysis describing

the impact of the regulatory action on

small entities as part of the rulemaking.

However, under section 605(b) of the

RFA, if EPA certifies that the rule will

not have a significant economic impact

on a substantial number of small

entities, EPA is not required to prepare

a regulatory flexibility analysis.

Pursuant to section 605(b) of the RFA,

the Administrator certifies that this rule

will not have a significant economic

impact on a substantial number of small

entities.

The RFA authorizes use of an

alternative definition to that of the

Small Business Administration for a

small water utility. Throughout the

1992–93 negotiated rulemaking process

for the Stage 1 DBPR and IESWTR and

in the July 1994 proposals for these

rules, a small public water system

(PWS) was defined as a system serving

fewer than 10,000 persons. This

definition reflects the fact that the

original 1979 standard for total

trihalomethanes applied only to systems

serving at least 10,000 people. The

definition thus recognizes that baseline

conditions from which systems serving

fewer than 10,000 people will approach

disinfection byproduct control and

simultaneous control of microbial

pathogens is different than that for

systems serving 10,000 or more persons.

EPA again discussed this approach to

the definition of a small system for these

rules in the March 1998 Disinfectants/

Disinfection Byproducts Notice of Data

Availability (63 FR 15676, March 31,

1998). EPA is continuing to define

‘‘small system’’ for purposes of this rule

and the Stage 1 DBPR as a system which

serves fewer than 10,000 people. The

IESWTR applies only to systems serving

at least 10,000 people and accordingly

does not have a significant economic

impact on a substantial number of small

entities. Accordingly EPA has not

completed a regulatory flexibility

analysis for the IESWTR or a small

entity compliance guide.

The Agency has since proposed and

taken comment on its intent to define

‘‘small entity’’ as a public water system

that serves 10,000 or fewer persons for

purposes of its regulatory flexibility

assessments under the RFA for all future

drinking water regulations. (See

Consumer Confidence Reports Rule, 63

FR 7620, Feb. 13, 1998.) In that

proposal, the Agency discussed the

basis for its decision to use this

definition and to use a single definition

of small public water system whether

the system was a ‘‘small business’’,

‘‘small nonprofit organization’’, or

‘‘small governmental jurisdiction.’’ EPA

also consulted with the Small Business

Administration on the use of this

definition as it relates to small

businesses. Subsequently, the Agency

has used this definition in developing

its regulations under the Safe Drinking

Water Act. This approach is virtually

identical to the approach used in the

IESWTR and Stage 1 DBPR.

B. Paperwork Reduction Act

The Office of Management and Budget

(OMB) has approved the information

collection requirements contained in

this rule under the provisions of the

Paperwork Reduction Act, 44 U.S.C.

3501 et seq. and has assigned OMB

control number 2040–0205.

The information collected as a result

of this rule will allow the States and

EPA to evaluate PWS compliance with

the rule. For the first three years after

promulgation of this rule, the major

information requirements pertain to

monitoring, compliance reporting and

sanitary surveys. Responses to the

request for information are mandatory

(Part 141). The information collected is

not confidential.

EPA is required to estimate the

burden on PWS for complying with the

final rule. 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.

EPA estimates that the annual burden

on PWS and States for reporting and

recordkeeping will be 150,557 hours.

This is based on an estimate that there

will be 998 respondents per year who

will each, on average, need to provide

3,803 responses and that the average

response will take 40 hours. The total

annual cost burden is $27,448,013. This

includes total annual labor costs of

$4,615,791 for the following activities:

reading and understanding the rule,

planning, training, data collection, data

review, data reporting, recordkeeping,

compliance tracking and making

determinations. The cost burden also

includes capital costs of $17,137,222 for

turbidimeter installation by PWS, and

an operations and maintenance cost of

$5,695,000 for turbidimeters.

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.

EPA is amending the table in 40 CFR

part 9 of currently approved ICR control

numbers issued by OMB for various

regulations to list the information

requirements contained in this final

rule. This ICR was previously subject to

public notice and comment prior to

OMB approval. As a result, EPA finds

that there is ‘‘good cause’’ under section

553 (b) (B) of the Administrative

Procedures Act (5 U.S.C. 553 (b) (B) to

amend this table without prior notice

and comment. Due to the technical

nature of the table, further notice and

comment would be unnecessary.

C. Unfunded Mandates Reform Act

1. Summary of UMRA requirements

Title II of the Unfunded Mandates

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

104–4, establishes requirements for

Federal agencies to assess the effects of

their regulatory actions on State, local,
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69507

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 expenditures to State, local,

and tribal governments, in the aggregate,

or to the private sector, of $100 million

or more in any one year. Before

promulgating an EPA rule for which a

written statement is needed, section 205

of the UMRA generally requires EPA to

identify and consider a reasonable

number of regulatory alternatives and

adopt the least costly, most costeffective 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 an explanation

why that alternative was not adopted

with the final rule.

Before EPA establishes any regulatory

requirements that may significantly or

uniquely affect small governments,

including tribal governments, it must

have developed under section 203 of the

UMRA a small government agency plan.

The plan must provide for notifying

potentially affected small governments,

enabling officials of affected small

governments to have meaningful and

timely input in the development of EPA

regulatory proposals with significant

Federal intergovernmental mandates,

and informing, educating and advising

small governments on compliance with

the regulatory requirements.

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 State, local, and tribal

governments, in the aggregate and the

private sector in any one year.

Accordingly, EPA has prepared under

section 202 of the UMRA a written

statement which is summarized below.

The written statement addresses the

following areas: (a) Authorizing

legislation; (b) cost-benefit analysis

including an analysis of the extent to

which the costs of State, local and

Tribal governments will be paid for by

the Federal government; (c) estimates of

future compliance costs and

disproportionate budgetary effects; (d)

macro-economic effects; and (e) a

summary of EPA’s consultation with

State, local, and Tribal governments and

their concerns, including a summary of

the Agency’s evaluation of those

comments and concerns; (f)

identification and consideration of

regulatory alternatives; and (g) selection

of the least costly, most cost-effective or

least burdensome alternative that

achieves the objectives of the rule. The

major points of this written statement

are summarized below. A more detailed

description of this analysis is presented

in EPA’s Unfunded Mandates Reform

Act Analysis for the IESWTR

(EPA,1998c) which is included in the

docket for this rule.

a. Authorizing Legislation

Today’s rule is promulgated pursuant

to (section 1412(b)(2)(C)) of the 1996

amendments to the SDWA; paragraph C

of this section establishes a statutory

deadline of November 1998 to

promulgate this rule. In addition, the

Interim Enhanced Surface Water

Treatment Rule (IESWTR) is closely

integrated with the Stage 1 DBPR, which

also has a statutory deadline of

November 1998.

b. Cost Benefit Analysis

Section V of this preamble discusses

in detail the cost and benefits associated

with the IESWTR. Also, the EPA’s

Regulatory Impact Analysis of the

Interim Enhanced Surface Water

Treatment Rule (EPA, 1998a) contains a

detailed cost benefit analysis. The

analysis includes both qualitative and

monetized benefits for improvements to

health and safety. Because of scientific

uncertainty regarding the exposure

assessment and the risk assessment for

Cryptosporidium, the Agency calculated

partial monetary benefit estimates for

three different scenarios (low, medium,

high) of improved removal of

Cryptosporidium concentrations

assuming two different levels of current

inactivation (2.5 log baseline or 3.0 log

baseline). Potential monetized annual

benefits for illness avoided associated

with Cryptosporidium ranged from a

mean of $0.263 billion (3.0 log) to a

mean of $1.24 billion (2.5 log) for this

rule depending upon varied baseline

and improved Cryptosporidium removal

assumptions. The benefits from

reduction in exposure to

Cryptosporidium have been compared

with the aggregate annualized costs to

State, local, and tribal governments and

the private sector that totaled

approximately $307 million (annualized

at 7%).

Using a current national average

treatment removal assumption of 3.0

logs, net benefits are positive under the

high and mid improved removal

scenarios. Net benefits using the 3.0 log

current removal assumption are

negative near and below the mean

associated with the low improved

removal assumption using only the

value of cost of illness avoided;

however, when the value of mortalities

prevented is added with the benefits, all

scenarios have positive net benefits at

the mean.

Thus, the monetized net benefits are

positive across most of the range of

current treatment assumptions,

improved log removal scenarios, and

discount rates. The benefits due to the

illnesses avoided may be slightly

overstated because mortalities were not

netted out of the number of illnesses

avoided. This value is minimal and

would not be captured at the level of

significance of the analysis. Other

possible benefits considered in the

analysis but not monetized are reducing

the risk of outbreaks, reducing the

exposure to other pathogens, enhancing

aesthetic water quality, avoiding the

cost of averting behavior, and reducing

the cost of pain and suffering. These

benefits could add substantial economic

value to this rule.

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 primacy 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 the Drinking Water State

Revolving Fund (DWSRF) 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 will have considerable

flexibility to determine the design of its

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 ten

percent of their DWSRF allotments for

each fiscal year to assist in running the

State drinking water program.

c. Estimates of Future Compliance Costs

and Disproportionate Budgetary Effects

EPA believes that the cost estimates

indicated above in Section V to be a

fairly accurate assessment of future
69508 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

compliance costs and generally does not

anticipate any disproportionate

budgetary effects. In general, the costs

that a public water system, whether

publicly or privately owned, will incur

to comply with this rule will depend on

many factors that are not generally

based on location. However, the data

needed to confirm this assessment and

to analyze other impacts of this problem

are not available; therefore, EPA looked

at three other factors: The impacts of the

regulation on small versus large

systems, the costs to public versus

private water systems, and the costs to

households. First, EPA notes that the

IESWTR does not have a significant

impact on a substantial number of small

entities, as discussed previously in

Section VII.A. These small systems are

the subject of a subsequent rulemaking

planned for 2000.

Second, the review of costs to public

versus private systems is based on

estimates of the allocation of the

systems across size categories and can

only be viewed as an indication of

possible impacts. More important,

implementation of the rule affects both

public and private water systems

equally, with the variance in total cost

by system size merely a function of the

number of affected systems. This

analysis is presented in further detail in

the IESWTR UMRA Analysis Document

(EPA, 1998c).

Finally, the highest estimated

household costs would be for those

households served by systems that

would have to implement all proposed

combined filter effluent alternative

treatment activities to meet the 0.3 NTU

requirement for 95 percent of samples in

a given month and a maximum of 1

NTU. However, this analysis may

overstate costs because these systems

may choose a less costly alternative

such as point-of-use devices, selecting

alternative water sources, or connecting

to a larger regional water system.

d. Macro-economic Effects

As required under UMRA Section

202, EPA is required to estimate the

potential macro-economic effects of the

regulation. 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 1997,

real GDP was $7,188 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 IESWTR should be negligible based

on the fact that the total annual costs are

about $307 million per year (at a 7

percent cost of capital) and the costs are

not expected to be highly focused on a

particular geographic region or sector.

e. Summary of EPA’s Consultation With

State, Local, and Tribal Government and

Their Concerns

Under UMRA section 202, EPA is to

provide a summary of its consultation

with elected representatives (or their

designated authorized employees) of

affected State, local and Tribal

governments in this rulemaking.

Although this rule was proposed before

UMRA became a statutory requirement,

EPA initiated consultations with

governmental entities and the private

sector affected by this rule through

various means. This included

participation on a Regulatory

Negotiation Committee, chartered under

the Federal Advisory Committee Act

(FACA), in 1992–93 that included

stakeholders representing State and

local governments, public health

organizations, public water systems,

elected officials, consumer groups, and

environmental groups.

After the amendments to SDWA in

1996, the Agency initiated a second

FACA process, similarly involving a

broad range of stakeholders, and held

meetings during 1997 to address the

expedited deadline for promulgation of

the IESWTR in November 1998. EPA

established the M–DBP Advisory

Committee to collect, share, and analyze

new data reviewed since the earlier Reg.

Neg. process and also to build a

consensus on the regulatory

implications of this new information.

The M–DBP Advisory Committee

established a technical working group to

assist them with the many scientific

issues surrounding this rule. The

Committee included representatives

from organizations such as the National

League of Cities, the National

Association of City and County Health

Officials, the Association of

Metropolitan Water Agencies, the

Association of State Drinking Water

Administrators, and the National

Association of Water Companies. In

addition, the Agency invited the Native

American Water Association to

participate in the FACA process to

develop this rule. Although they

eventually decided not to take part, the

Association continued to be informed of

meetings and developments through a

stakeholders mailing list. Stakeholders

who participated in the FACA

processes, as well as all other interested

members of the public, were invited to

comment on the proposed rule and

NODA. Also, as part of the Agency’s

Communication Strategy, EPA sent

copies of the proposed rule and NODA

to many stakeholders, including six

tribal associations.

In addition, the Agency notified

governmental entities and the private

sector of opportunities to provide input

on this rule in the Federal Register on

July 29, 1994 (59 FR 38832) and on

November 3, 1997 (62 FR 59485). EPA

received written comments from

approximately 37 commenters on the

July 29, 1994 notice and from

approximately 157 commenters on the

November 3, 1997 notice. Of the 37

commenters on the 1994 proposed rule,

approximately 22% were States and

35% were local governments. Of the 157

commenters on the 1997 Notice of Data

Availability, approximately 8% were

States and 27% were local governments.

The public docket for this rulemaking

contains all comments received by the

Agency and provides details about the

nature of State and local governments’

concerns. Issues addressed by State and

local government commenters included

concerns about the cost and feasibility

of proposed regulatory alternatives to

require treatment levels based on

Giardia and/or Cryptosporidium

occurrence in a public water system’s

source water; preferences for requiring 2

log removal of Cryptosporidium for

filtered systems; and concerns about the

feasibility of requiring source water

monitoring for unfiltered systems. A

number of commenters on the issue of

sanitary survey frequencies supported

the three and five years frequencies for

community and non-community water

systems, respectively, as recommended

by the M–DBP Advisory Committee.

Some State commenters, however,

expressed concern about resources for

carrying out the surveys on such a

schedule. On the issue of flexibility in

implementing the Stage 1 DBPR and

IESWTR to ensure that the rules are

implemented simultaneously, most

commenters preferred option four

(discussed in the November 1997

IESWTR NODA) that calls for

simultaneous implementation of both

the IESWTR and the Stage 1 DBPR.

EPA understands the State and local

government concerns noted above. EPA

agrees that of the regulatory alternatives

proposed, the appropriate alternative is

the 2 log removal requirement for

Cryptosporidium included in the final

rule; the rule does not include treatment

requirements based on microbial

occurrence in source water. Nor does it

require source water monitoring for

unfiltered systems, based in part on

concerns about current availability of
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69509

analytical methods. With respect to

sanitary survey frequencies, the final

IESWTR reflects the M–DBP Advisory

Committee’s recommendations,

including provisions that allow States to

(1) grandfather surveys done after

December 1995 if they address eight

elements that are currently part of

existing State/EPA guidance; (2) do

sanitary surveys on a five-year instead

of a three-year schedule for community

water systems that the State determines

to be outstanding performers; and (3)

carry out survey components in a staged

or phased manner within the

established frequency. EPA believes that

these frequencies and associated

provisions in the final rule allow States

the flexibility to prioritize and carry out

the sanitary survey process as an

effective tool to identify and correct

water system deficiencies that could

pose a threat to public health. EPA

agrees that concurrent implementation

of the Stage 1 DBPR and IESWTR, as

described in option 4 and reflected in

the final Stage 1 DBPR compliance

schedules, is the most effective means of

implementing both rules. Finally, the

Agency believes that the final IESWTR

will provide public health benefits that

justify the costs of the rule by reducing

the public’s exposure to microbial

pathogens, including Cryptosporidium.

EPA notes that, as discussed in Section

V. above, over 90% of affected

households will incur costs of less than

$1 per month.

f. Regulatory Alternatives Considered

As required under section 205 of the

UMRA, EPA considered several

regulatory alternatives that developed

from the Regulatory Negotiation

process, M–DBP Advisory Committee,

and stakeholder comments. These

approaches sought to improve microbial

protection and balance the risk/risk

tradeoff of controlling microbial

pathogens while simultaneously

limiting the formation of disinfection

byproducts. EPA proposed core

requirements related to ground water

under the direct influence of surface

water, watershed control for unfiltered

systems and sanitary surveys for all

surface water systems, as well as five

treatment alternatives for controlling

pathogens, including a number of suboptions. In addition, the Agency

requested comment on possible

supplemental treatment requirements

for requiring covers on finished water

reservoirs, cross connection control

programs and State notification of high

turbidity levels and other issues related

to turbidity control. Among these

various approaches, the Agency was

unable to pursue certain ones in the

final IESWTR because additional data

was needed.

Additional analysis of the regulatory

alternatives was provided by the M–

DBP Advisory Committee. The M–DBP

Advisory Committee assessed tightening

turbidity performance criteria and

monitoring individual filtration

performance. The Committee discussed

at least one alternative that would have

required the use of membrane

technology to improve turbidity

performance but concluded that utilities

could more affordably achieve sufficient

performance levels through changes in

operation and administrative practices.

The Committee considered three

different turbidity standards as well as

some existing State requirements for

individual filter monitoring. A more

detailed description of these alternatives

is discussed in Chapter V of the IESWTR

Regulatory Impact Analysis (EPA,

1998a).

g. Selection of the Least Costly, Most

Cost-Effective or Least Burdensome

Alternative That Achieves the

Objectives of the Rule

As discussed above, EPA considered

various regulatory options that would

reduce exposures to pathogens and

disinfectant byproducts that are the

objectives of the SDWA. For instance,

the M–DBP Committee analyzed the

cost for three different levels of turbidity

performance for the combined filter

effluent turbidity requirements

(measured in NTUs). The three NTU

limits considered at the 95th percentile

were 0.1, 0.2, and 0.3 and their cost

estimates show a clear distinction

among the three different levels. At the

0.1 NTU, the total annual costs of

treatment were estimated to be $3,213

million. At 0.2 NTU and 0.3 NTU, the

total annual costs of treatment were

estimated to be $317 million and $174

million, respectively. The costs of the

0.1 NTU requirement were roughly 20

times the 0.3 NTU scenario and 10 times

the 0.2 NTU scenario.

The large increase in costs for the 1.0

NTU scenario occurs because it was

assumed that 95 percent of systems

would need to install costly membrane

technology to comply with this level.

Most of the difference between the 0.2

and 0.3 levels is attributable to twice as

many systems having to install

coagulant aid polymer feed and filter

aid polymer feed capabilities in

complying with the 0.2 NTU limit as

compared with the 0.3 NTU limit. The

Committee recommended the 0.3 option

because they felt that this level would

provide adequate health protection at

the least cost. The 0.3 NTU limit was

the option that was eventually adopted

as part of this rule and is the least costly

option that accomplishes the objectives

of the IESWTR.

3. Impacts on Small Governments

EPA has determined that this rule

contains no regulatory requirements that

might significantly or uniquely effect

small governments. Thus this rule is not

subject to the requirements of section

203 of UMRA. For purposes of the

IESWTR, EPA has defined small public

water systems as those that serve a

population of fewer than 10,000, as

discussed above in Section VIIA.

Consequently, section 203 of UMRA

does not apply because, as discussed

above, the IESWTR applies to systems

serving 10,000 or more people. As noted

above, EPA plans to address surface

water systems serving fewer than 10,000

people in the Long Term 1 Enhanced

Surface Water Treatment Rule.

Even though section 203 does not

apply, the FACA processes gave a

variety of stakeholders, including small

governments, the opportunity for timely

and meaningful participation in the

regulatory development process. Groups

such as the National Association of City

and County Health Officials and the

National League of Cities participated in

the rule making process. Through such

participation and exchange, EPA

notified small governments of

requirements under consideration and

provided officials of these small

governments with an opportunity to

have meaningful and timely input into

the development of regulatory

proposals.

D. National Technology Transfer and

Advancement Act

Under section 12(d) of the National

Technology Transfer and Advancement

Act (‘‘ANTTAA’’), the Agency is

required 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, business

practices, etc.) that are developed or

adopted by voluntary consensus

standards bodies. Where available and

potentially applicable voluntary

consensus standards are not used by

EPA, the Act requires the Agency to

provide Congress, through the Office of

Management and Budget, an

explanation of the reasons for not using

such standards.

Today’s rule requires the use of

previously approved technical

standards for the measurement of

turbidity. In previous rulemakings, EPA
69510 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

approved three methods for measuring

turbidity in drinking water. Turbidity is

a method-defined parameter and

therefore modifications to any of the

three approved methods requires prior

EPA approval. One of the approved

methods was published by the Standard

Methods Committee of American Public

Health Association, the American Water

Works Association, and the Water

Environment Federation, a voluntary

consensus standard body. That method,

Method 2130B is published in Standard

Methods for the Examination of Water

and Wastewater (19th ed.). Standard

Methods is a widely used reference

which has been peer-reviewed

throughout the scientific community. In

addition to this voluntary consensus

standard, EPA approved Great Lakes

Instrument Method 2 as an alternate test

procedure for the measurement of

turbidity. Finally, the Agency approved

a revised EPA Method 180.1 for

turbidity measurement in August 1993

in Methods for the Determination of

Inorganic Substances in Environmental

Samples (EPA–600/R–93–100).

In 1994, EPA reviewed and rejected

an additional technical standard for the

measurement of turbidity, the ISO 7027

standard, which measures turbidity at a

higher wavelength than the approved

test measurement standards. The ISO

7027 is an analytical method for the

measurement of turbidity. ISO 7027

measures turbidity using either 90°

scattered or transmitted light depending

on the turbidity concentration

evaluated. Although instruments

conforming to ISO 7027 specifications

are similar to the GLI instrument, only

the GLI instrument uses pulsed,

multiple detectors to simultaneously

read both 90° scattered and transmitted

light. EPA has no data upon which to

evaluate whether the separate 90°

scattered or transmitted light

measurement evaluations according to

the ISO 7027 method would produce

results that are equivalent to results

produced using GLI Method 2, Standard

Method 2130B, or EPA Method 180.1.

Today’s final rule also requires

continuous individual filter monitoring

for turbidity and requires PWSs to

calibrate the individual turbidimeter

according to the turbidimeter

manufacturer’s instructions. These

calibration instructions may constitute

technical standards as that term is

defined in the NTTAA. EPA has looked

for voluntary consensus standards with

regard to calibration of turbidimeter.

The American Society for Testing and

Materials (ASTM) is developing such

voluntary consensus standards;

however, there do not appear to be any

voluntary consensus standards available

at this time.

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 entitlements, 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, it has been determined

that this rule is a ‘‘significant regulatory

action’’ because it will have an annual

effect on the economy of $100 million

or more. 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 (59 FR 7629)

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

related issues concerning the potential

impacts of this action and has consulted

with minority and low-income

stakeholders.

Three aspects of today’s rule comply

with the Environmental Justice

Executive Order and they can be

classified as follows: (1) The overall

nature of the rule; (2) the inclusion of

sensitive sub-populations in the

regulatory development process; and (3)

the convening of a stakeholder meeting

specifically to address environmental

justice issues. The IESWTR applies

uniformly to all surface water and

GWUDI systems that serve a population

of at least 10,000 and consequently, the

health protection benefits this rule

provides are equal across all income and

minority groups within these

communities. A complementary

regulation is under development that

will address similar issues for systems

serving fewer than 10,000 people.

In addition, concerns of the sensitive

sub-populations were included in the

IESWTR through the Reg. Neg. and MDBP Advisory Committee process

undertaken to craft the regulation. Both

Committees were chartered under the

FACA authorization, and included a

broad cross-section of regulators,

regulated communities, industry, public

interest groups, and State and local

public health officials. Representatives

of sensitive sub-populations, in

particular people with AIDS,

participated in the regulatory

development process. Extensive

discussion on setting treatment

requirements that provide the maximum

feasible protection took place, and the

final consensus that resulted in the rule

considered issues of affordability,

equity, and safety.

Finally, as part of EPA’s

responsibilities to comply with E.O.

12898, the Agency held a stakeholder

meeting on March 12, 1998 (EPA 1998e)

to address various components of

pending drinking water regulations; and

how they may impact sensitive subpopulations, 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 between 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 (EPA

1998e) 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 OGWDW regulatory

efforts.

In addition, EPA developed a plainEnglish guide specifically for this
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69511

meeting to assist stakeholders in

understanding the multiple and

sometimes complex issues surrounding

drinking water regulation.

Overall, EPA believes this rule will

equally protect the health of all minority

and low income populations within

communities served by public water

systems regulated under this rule.

G. Executive Order 13045: Protection of

Children From Environmental Health

Risks and Safety Risks

Executive Order 13045 (62 FR 19885,

April 23, 1997) applies to any rule

initiated after April 21, 1997, or

proposed after April 21, 1998, that (1) is

determined to be ‘‘economically

significant’’ as defined under E.O. 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.

The final rule is not subject to the

Executive Order because EPA published

a notice of proposed rulemaking before

April 21, 1998. However, EPA’s policy

since November 1, 1995, is to

consistently and explicitly consider

risks to infants and children in all risk

assessments generated during its

decision making process including the

setting of standards to protect public

health and the environment.

In promulgating the IESWTR the

Agency recognizes that the health risks

associated with exposure to the

protozoan Cryptosporidium are of

particular concern for certain sensitive

subpopulations, including children and

immunocompromised individuals.

These concerns were considered as part

of the regulatory development process,

particularly in the establishment of the

MCLG for Cryptosporidium in drinking

water, and are reflected in the final rule.

The IESWTR establishes a Maximum

Contaminant Level Goal (MCLG) of zero

for Cryptosporidium at the genus level,

taking into account the need to protect

sensitive populations (e.g., children)

and providing for an adequate margin of

safety. For public water systems that use

surface water, filter and serve at least

10,000 people, the Agency is

establishing physical removal treatment

requirements for Cryptosporidium. For

systems that use conventional or direct

filtration, the Agency is strengthening

the existing turbidity standards for

finished water and is also requiring

individual filter monitoring to assist in

controlling pathogen breakthrough

during the treatment process.

H. Executive Order 12875: Enhancing

the Intergovernmental Partnership

Under Executive Order 12875, EPA

may not issue a regulation that is not

required by statute and that creates a

mandate upon a State, local or tribal

government, unless the Federal

government provides the funds

necessary to pay the direct compliance

costs incurred by those governments, or

EPA consults with those governments. If

EPA complies by consulting, Executive

Order 12875 requires EPA to provide to

the Office of Management and Budget a

description of the extent of EPA’s prior

consultation with representatives of

affected State, local and tribal

governments, the nature of their

concerns, copies of any written

communications from the governments,

and a statement supporting the need to

issue the regulation. In addition,

Executive Order 12875 requires EPA to

develop an effective process permitting

elected officials and other

representatives of State, local and tribal

governments ‘‘to provide meaningful

and timely input in the development of

regulatory proposals containing

significant unfunded mandates.’’

EPA has concluded that this rule will

create a mandate on State, local, and

tribal governments and that the Federal

government will not provide all of the

funds necessary to pay the direct costs

incurred by the State, local, and tribal

governments in complying with the

mandate. In developing this rule, EPA

consulted with State and local

governments to enable them to provide

meaningful and timely input in the

development of this rule. EPA also

invited the Native American Water

Association to participate in the FACA

process to develop this rule. Although

they decided not to take part in the

deliberations, the Association continued

to be informed of meetings and

developments through a stakeholders

mailing list.

As described above in Section VII.

C.2(e), EPA held extensive meetings

with a variety of State and local

representatives who provided

meaningful and timely input in the

development of the proposed rule. State

and local representatives were part of

the FACA committees involved in the

development of this rule. Summaries of

the meetings have been included in the

public docket for this rulemaking. See

section VII.C.2(e) for summaries of the

extent of EPA’s consultation with State,

local, and tribal governments; the nature

of the government concerns; and EPA’s

position supporting the need to issue

the rule.

I. 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 Office of

Management and Budget, 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.’’

Today’s rule does not significantly or

uniquely affect the communities of

Indian tribal governments. There are

very few Tribal surface water systems

that serve 10,000 or more people.

Moreover, the rule does not impose

requirements on the Tribal systems that

differ from those required for other

water systems covered under the rule.

Accordingly, the requirements of

section 3(b) of Executive Order 13084

do not apply to this rule.

J. Consultation With the Science

Advisory Board, National Drinking

Water Council, and Secretary of Health

and Human Services

In accordance with section 1412(d)

and (e) of SDWA, EPA consulted with

the Science Advisory Board, National

Drinking Water Council, and Secretary

of Health and Human Services, and

requested and considered their

comments in developing this rule.

K. Likely Effect of Compliance With the

IESWTR on the Technical, Financial,

and Managerial Capacity of Public

Water Systems

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

amended requires that, in promulgating

a NPDWR, the Administrator shall
69512 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

include an analysis of the likely effect

of compliance with the regulation on

the technical, financial, and managerial

capacity of public water systems. The

following analysis has been performed

to fulfill this statutory obligation.

Overall water system capacity is

defined in EPA guidance (EPA 816–R–

98–006) (EPA 1998g) as the ability to

plan for, achieve, and maintain

compliance with applicable drinking

water standards. Capacity has three

components: technical, managerial, and

financial.

Technical capacity is the physical and

operational ability of a water system to

meet SDWA requirements. Technical

capacity refers to the physical

infrastructure of the water system,

including the adequacy of source water

and the adequacy of treatment, storage,

and distribution infrastructure. It also

refers to the ability of system personnel

to adequately operate and maintain the

system and to otherwise implement

requisite technical knowledge. A water

system’s technical capacity can be

determined by examining key issues

and questions, including:

• Source water adequacy. Does the

system have a reliable source of

drinking water? Is the source of

generally good quality and adequately

protected?

• Infrastructure adequacy. Can the

system provide water that meets SDWA

standards? What is the condition of its

infrastructure, including well(s) or

source water intakes, treatment, storage,

and distribution? What is the

infrastructure’s life expectancy? Does

the system have a capital improvement

plan?

• Technical knowledge and

implementation. Is the system’s operator

certified? Does the operator have

sufficient technical knowledge of

applicable standards? Can the operator

effectively implement this technical

knowledge? Does the operator

understand the system’s technical and

operational characteristics? Does the

system have an effective operation and

maintenance program?

Managerial capacity is the ability of a

water system to conduct its affairs in a

manner enabling the system to achieve

and maintain compliance with SDWA

requirements. Managerial capacity refers

to the system’s institutional and

administrative capabilities.

Managerial capacity can be assessed

through key issues and questions,

including:

• Ownership accountability. Are the

system owner(s) clearly identified? Can

they be held accountable for the system?

• Staffing and organization. Are the

system operator(s) and manager(s)

clearly identified? Is the system

properly organized and staffed? Do

personnel understand the management

aspects of regulatory requirements and

system operations? Do they have

adequate expertise to manage water

system operations? Do personnel have

the necessary licenses and

certifications?

• Effective external linkages. Does the

system interact well with customers,

regulators, and other entities? Is the

system aware of available external

resources, such as technical and

financial assistance?

Financial capacity is a water system’s

ability to acquire and manage sufficient

financial resources to allow the system

to achieve and maintain compliance

with SDWA requirements.

Financial capacity can be assessed

through key issues and questions,

including:

• Revenue sufficiency. Do revenues

cover costs? Are water rates and charges

adequate to cover the cost of water?

• Credit worthiness. Is the system

financially healthy? Does it have access

to capital through public or private

sources?

• Fiscal management and controls.

Are adequate books and records

maintained? Are appropriate budgeting,

accounting, and financial planning

methods used? Does the system manage

its revenues effectively?

1,381 systems are affected by the

IESWTR. Of these, 691 may need to

modify their treatment process and

undertake turbidity monitoring, and

will need to meet the disinfection

benchmarking and turbidity exceptions

reporting requirements. The other 690

systems will need to do turbidity

monitoring and will need to meet the

disinfection benchmarking and turbidity

exceptions reporting requirements as

applicable, but will not need to modify

their treatment process.

Systems not modifying treatment will

need to do turbidity monitoring,

disinfection benchmarking, and

turbidity exceptions reporting, These

systems are not generally expected to

require significantly increased

technical, financial, or managerial

capacity to comply with these new

requirements. Some individual facilities

may have weaknesses in one or more of

these areas, but overall surface water

systems should have or be able to easily

obtain the capacity needed for these

activities.

Systems needing to modify treatment

will employ one or more of a variety of

steps. The steps expected to be

employed by 25% or more of systems in

virtually all size categories covered by

the rule are: install backwash water

polymer feed capability; install

individual filter turbidimeters; account

for recycle flow in process control

decisions; implement a policy and

commitment to lower water quality

goals; utilize alternative process control

testing equipment; modify/implement

process control monitoring and control;

and designate a process control strategy

facilitator.

Furthermore, there are a number of

actions that are expected to be taken

disproportionately by the smaller sized

systems covered under the IESWTR

(that is to say, a greater percentage of

smaller sized systems will undertake

these activities than will larger sized

systems). These steps include:

Structural and mechanical rapid mix

improvements; filter underdrain

retrofits and gravel media; filter rate-offlow controller replacement; hydraulic

improvements in flow distribution/

control/measurement; increase plant

staffing; replace obsolete bench top

turbidimeters; purchase jar test

apparatus; and train staff to understand

process control strategy.

For many systems serving between

10,000 and 100,000 persons which need

to make treatment modifications an

enhancement of technical, financial,

and managerial capacity may likely be

needed. As the preceding paragraph

makes clear, these systems will be

making structural improvements and

enhancing laboratory and staff capacity.

Larger sized systems have typically

already made these improvements as

part of normal operations. Meeting the

requirements of the IESWTR will

require operating at a higher level of

sophistication and in a better state of

repair than some plants in the 10,000–

100,000 person size category have

considered acceptable in the past.

Certainly there will be exceptions

both between 10,000 and 100,000

persons and above. Some larger plants

are expected to find that their technical,

managerial, and financial capacity

needs to be upgraded to support the

system in meeting the new

requirements. Likewise, some plants

serving 10,000–100,000 persons will

already have more than adequate

technical, financial, and managerial

capacity to meet these requirements.

However, in general, the systems

serving 10,000–100,000 persons needing

to make treatment modifications will be

the ones most needing to enhance their

capacity.

L. Submission to Congress and the

General Accounting Office

The Congressional Review Act, 5

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

Business Regulatory Enforcement
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69513

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. A major rule

cannot take effect until 60 days after it

is published in the Federal Register.

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

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

effective February 16, 1999.

VIII. References

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Arrowood, M J (1997). Diagnosis. pp. 43–

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AWWA Water Industry Data Base (WIDB)

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AWWA (1993). American Water Works

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1998.

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Availability; 62 FR59486.

EPA (1997b) National Primary Drinking

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Availability; 62 FR 59388.

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Statistical Performance of a Method f or

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for Public Drinking Water Supplies; Final

Rule. May 14, 1996. 61 FR 24354.

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Pathogens and Disinfection Byproduct in

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(ASDWA), and National Association of Water

Companies (NAWC) (1995). Partnership for

Safe Water Voluntary Water Treatment Plant

Performance Improvement Program SelfAssessment Procedures. October, 1995.

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Sanitary Surveys. December 1995.

EPA (1994a). National Primary Drinking

Water Regulations; Disinfectants and

Disinfection Byproducts; Proposed Rule. 59

FR 38668, July 29, 1994. EPA/811–Z–94–004.

EPA (1994b). National Primary Drinking

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FR 38832: July 29, 1994.

EPA (1994c). Monitoring Requirements for

Public Drinking Water Supplies; Proposed

Rule. 59 FR 6332, February 10, 1994.

EPA (1994d). Training on GWUDI

Determinations Workshop Manual. Office of

Groundwater and Drinking Water, EPA.

Washington DC (April 1994).

EPA (1994e). January 10, 1994 letter from

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List of Subjects

40 CFR Parts 9

Reporting and recordkeeping

requirements.

40 CFR Parts 141 and 142

Drinking water, Environmental

protection, Public utilities, Reporting

and recordkeeping requirements,

Reservoirs, Utilities, Water supply,

Watersheds.

Dated: November 30, 1998.

Carol M. Browner,

Administrator.

For the reasons set out in the

preamble, title 40 chapter I of the Code

of Federal Regulations is amended as

follows:

PART 9—[AMENDED]

1. The authority citation for part 9

continues to read as follows:

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

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

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

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

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

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,

1971–1975 Comp. p. 973; 42 U.S.C. 241,

242b, 243, 246, 300f, 300g, 300g-1, 300g-2,

300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901–

6992k, 7401–7671q, 7542, 9601–9657, 11023,

11048.

2. In § 9.1 the table is amended by

adding under the indicated heading the

new entries in numerical order to read

as follows:

§ 9.1 OMB approvals under the Paperwork

Reduction Act.

* * * * *

40 CFR citation OMB control

no.

* * * * *

National Primary Drinking Water

Regulations

* * * * *

141.170 ................................. 2040–0205

141.172 ................................. 2040–0205

141.174–141.175 .................. 2040–0205

* * * * *

PART 141—National Primary Drinking

Water Regulations

3. The authority citation for part 141

continues to read as follows:

Authority: 42 U.S.C. 300f, 300g–1, 300g–2,

300g–3, 300g–4, 300g–5, 300g–6, 300j–4,

300j–9, and 300j–11.

4. Section 141.2 is amended by

revising the definition of ‘‘ground water

under the direct influence of surface

water’’ and adding the following

definitions in alphabetical order to read

as follows:

§ 141.2 Definitions.

* * * * *

Comprehensive performance

evaluation (CPE) is a thorough review

and analysis of a treatment plant’s

performance-based capabilities and

associated administrative, operation and

maintenance practices. It is conducted

to identify factors that may be adversely

impacting a plant’s capability to achieve

compliance and emphasizes approaches

that can be implemented without

significant capital improvements. For

purposes of compliance with subpart P

of this part, the comprehensive

performance evaluation must consist of

at least the following components:

Assessment of plant performance;

evaluation of major unit processes;

identification and prioritization of

performance limiting factors;

assessment of the applicability of

comprehensive technical assistance; and

preparation of a CPE report.

* * * * *

Disinfection profile is a summary of

daily Giardia lamblia inactivation

through the treatment plant. The

procedure for developing a disinfection

profile is contained in § 141.172.

* * * * *

Filter profile is a graphical

representation of individual filter

performance, based on continuous

turbidity measurements or total particle

counts versus time for an entire filter

run, from startup to backwash

inclusively, that includes an assessment

of filter performance while another filter

is being backwashed.

* * * * *

Ground water under the direct

influence of surface water means any

water beneath the surface of the ground

with significant occurrence of insects or

other macroorganisms, algae, or largediameter pathogens such as Giardia

lamblia or (for subpart H systems

serving at least 10,000 people only)

Cryptosporidium, or significant and

relatively rapid shifts in water

characteristics such as turbidity,

temperature, conductivity, or pH which

closely correlate to climatological or

surface water conditions. Direct

influence must be determined for

individual sources in accordance with

criteria established by the State. The

State determination of direct influence

may be based on site-specific

measurements of water quality and/or

documentation of well construction

characteristics and geology with field

evaluation.

* * * * *

Uncovered finished water storage

facility is a tank, reservoir, or other

facility used to store water that will

undergo no further treatment except

residual disinfection and is open to the

atmosphere.

* * * * *

5. Section 141.32 is amended by

revising paragraph (e)(10) to read as

follows:

§ 141.32 Public notification.

* * * * *

(e) * * *

(10) Microbiological contaminants (for

use when there is a violation of the

treatment technique requirements for

filtration and disinfection in subpart H

or subpart P of this part). The United

States Environmental Protection Agency

(EPA) sets drinking water standards and

has determined that the presence of

microbiological contaminants are a

health concern at certain levels of

exposure. If water is inadequately

treated, microbiological contaminants in

that water may cause disease. Disease

symptoms may include diarrhea,

cramps, nausea, and possibly jaundice,

and any associated headaches and

fatigue. These symptoms, however, are

not just associated with disease-causing

organisms in drinking water, but also

may be caused by a number of factors

other than your drinking water. EPA has

set enforceable requirements for treating

drinking water to reduce the risk of

these adverse health effects. Treatment

such as filtering and disinfecting the

water removes or destroys

microbiological contaminants. Drinking

water which is treated to meet EPA

requirements is associated with little to

none of this risk and should be

considered safe.

* * * * *

6. In § 141.52, the table is amended by

adding a new entry, in numerical order,

to read as follows:

§ 141.52 Maximum contaminant level goals

for microbiological contaminants.

* * * * *
69516 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

Contaminant MCLG

* * * * *

(5) Cryptosporidium ......................... zero.

7. Section 141.70 is amended by

adding paragraph (d) to read as follows:

§ 141.70 General requirements.

* * * * *

(d) Additional requirements for

systems serving at least 10,000 people.

In addition to complying with

requirements in this subpart, systems

serving at least 10,000 people must also

comply with the requirements in

subpart P of this part. 8. Section 141.71 is amended by

revising paragraph (b)(6) to read as

follows:

§ 141.71 Criteria for avoiding filtration.

* * * * *

(b) * * *

(6) The public water system must

comply with the requirements for

trihalomethanes in §§ 141.12 and 141.30

until December 17, 2001. After

December 17, 2001, the system must

comply with the requirements for total

trihalomethanes, haloacetic acids (five),

bromate, chlorite, chlorine,

chloramines, and chlorine dioxide in

subpart L of this part.

* * * * *

9. Section 141.73 is amended by

adding paragraph (a)(3) and revising

paragraph (d) to read as follows:

§ 141.73 Filtration.

* * * * *

(a) * * *

(3) Beginning December 17, 2001,

systems serving at least 10,000 people

must meet the turbidity requirements in

§ 141.173(a).

* * * * *

(d) Other filtration technologies. A

public water system may use a filtration

technology not listed in paragraphs (a)

through (c) of this section if it

demonstrates to the State, using pilot

plant studies or other means, that the

alternative filtration technology, in

combination with disinfection treatment

that meets the requirements of

§ 141.72(b), consistently achieves 99.9

percent removal and/or inactivation of

Giardia lamblia cysts and 99.99 percent

removal and/or inactivation of viruses.

For a system that makes this

demonstration, the requirements of

paragraph (b) of this section apply.

Beginning December 17, 2001, systems

serving at least 10,000 people must meet

the requirements for other filtration

technologies in § 141.173(b).

10. Section 141.153 is amended by

revising the first sentence of paragraph

(d)(4)(v)(C) to read as follows:

§ 141.153 Content of the reports.

* * * * *

(d) * * *

(4) * * *

(v) * * *

(C) When it is reported pursuant to

§§ 141.73 or 141.173: The highest single

measurement and the lowest monthly

percentage of samples meeting the

turbidity limits specified in §§ 141.73 or

141.173 for the filtration technology

being used. * * *

* * * * *

11. Part 141 is amended by adding a

new subpart P to read as follows:

Subpart P—Enhanced Filtration and

Disinfection

Sec.

141.170 General requirements.

141.171 Criteria for avoiding filtration.

141.172 Disinfection profiling and

benchmarking.

141.173 Filtration.

141.174 Filtration sampling requirements.

141.175 Reporting and recordkeeping

requirements.

§ 141.170 General requirements.

(a) The requirements of this subpart P

constitute national primary drinking

water regulations. These regulations

establish requirements for filtration and

disinfection that are in addition to

criteria under which filtration and

disinfection are required under subpart

H of this part. The requirements of this

subpart are applicable to subpart H

systems serving at least 10,000 people,

beginning December 17, 2001 unless

otherwise specified in this subpart. The

regulations in this subpart establish or

extend treatment technique

requirements in lieu of maximum

contaminant levels for the following

contaminants: Giardia lamblia, viruses,

heterotrophic plate count bacteria,

Legionella, Cryptosporidium, and

turbidity. Each subpart H system serving

at least 10,000 people must provide

treatment of its source water that

complies with these treatment

technique requirements and are in

addition to those identified in § 141.70.

The treatment technique requirements

consist of installing and properly

operating water treatment processes

which reliably achieve: (1) At least 99 percent (2-log) removal

of Cryptosporidium between a point

where the raw water is not subject to

recontamination by surface water runoff

and a point downstream before or at the

first customer for filtered systems, or

Cryptosporidium control under the

watershed control plan for unfiltered

systems. (2) Compliance with the profiling and

benchmark requirements under the

provisions of § 141.172.

(b) A public water system subject to

the requirements of this subpart is

considered to be in compliance with the

requirements of paragraph (a) of this

section if:

(1) It meets the requirements for

avoiding filtration in §§ 141.71 and

141.171 and the disinfection

requirements in §§ 141.72 and 141.172;

or

(2) It meets the applicable filtration

requirements in either § 141.73 or

§ 141.173 and the disinfection

requirements in §§ 141.72 and 141.172.

(c) Systems are not permitted to begin

construction of uncovered finished

water storage facilities beginning

February 16, 1999.

§ 141.171 Criteria for avoiding filtration.

In addition to the requirements of

§ 141.71, a public water system subject

to the requirements of this subpart that

does not provide filtration must meet all

of the conditions of paragraphs (a) and

(b) of this section.

(a) Site-specific conditions. In

addition to site-specific conditions in

§ 141.71(b), systems must maintain the

watershed control program under

§ 141.71(b)(2) to minimize the potential

for contamination by Cryptosporidium

oocysts in the source water. The

watershed control program must, for

Cryptosporidium:

(1) Identify watershed characteristics

and activities which may have an

adverse effect on source water quality;

and

(2) Monitor the occurrence of

activities which may have an adverse

effect on source water quality.

(b) During the onsite inspection

conducted under the provisions of

§ 141.71(b)(3), the State must determine

whether the watershed control program

established under § 141.71(b)(2) is

adequate to limit potential

contamination by Cryptosporidium

oocysts. The adequacy of the program

must be based on the

comprehensiveness of the watershed

review; the effectiveness of the system’s

program to monitor and control

detrimental activities occurring in the

watershed; and the extent to which the

water system has maximized land

ownership and/or controlled land use

within the watershed.

§ 141.172 Disinfection profiling and

benchmarking.

(a) Determination of systems required

to profile. A public water system subject

to the requirements of this subpart must

determine its TTHM annual average

using the procedure in paragraph (a)(1)

of this section and its HAA5 annual

average using the procedure in
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69517

paragraph (a)(2) of this section. The

annual average is the arithmetic average

of the quarterly averages of four

consecutive quarters of monitoring.

(1) The TTHM annual average must be

the annual average during the same

period as is used for the HAA5 annual

average.

(i) Those systems that collected data

under the provisions of subpart M

(Information Collection Rule) must use

the results of the samples collected

during the last four quarters of required

monitoring under § 141.142.

(ii) Those systems that use

‘‘grandfathered’’ HAA5 occurrence data

that meet the provisions of paragraph

(a)(2)(ii) of this section must use TTHM

data collected at the same time under

the provisions of §§ 141.12 and 141.30.

(iii) Those systems that use HAA5

occurrence data that meet the provisions

of paragraph (a)(2)(iii)(A) of this section

must use TTHM data collected at the

same time under the provisions of

§§ 141.12 and 141.30.

(2) The HAA5 annual average must be

the annual average during the same

period as is used for the TTHM annual

average.

(i) Those systems that collected data

under the provisions of subpart M

(Information Collection Rule) must use

the results of the samples collected

during the last four quarters of required

monitoring under § 141.142.

(ii) Those systems that have collected

four quarters of HAA5 occurrence data

that meets the routine monitoring

sample number and location

requirements for TTHM in §§ 141.12

and 141.30 and handling and analytical

method requirements of § 141.142(b)(1)

may use those data to determine

whether the requirements of this section

apply.

(iii) Those systems that have not

collected four quarters of HAA5

occurrence data that meets the

provisions of either paragraph (a)(2)(i)

or (ii) of this section by March 16, 1999

must either:

(A) Conduct monitoring for HAA5

that meets the routine monitoring

sample number and location

requirements for TTHM in §§ 141.12

and 141.30 and handling and analytical

method requirements of § 141.142(b)(1)

to determine the HAA5 annual average

and whether the requirements of

paragraph (b) of this section apply. This

monitoring must be completed so that

the applicability determination can be

made no later than March 16, 2000, or

(B) Comply with all other provisions

of this section as if the HAA5

monitoring had been conducted and the

results required compliance with

paragraph (b) of this section.

(3) The system may request that the

State approve a more representative

annual data set than the data set

determined under paragraph (a)(1) or (2)

of this section for the purpose of

determining applicability of the

requirements of this section.

(4) The State may require that a

system use a more representative annual

data set than the data set determined

under paragraph (a)(1) or (2) of this

section for the purpose of determining

applicability of the requirements of this

section.

(5) The system must submit data to

the State on the schedule in paragraphs

(a)(5)(i) through (v) of this section.

(i) Those systems that collected

TTHM and HAA5 data under the

provisions of subpart M (Information

Collection Rule), as required by

paragraphs (a)(1)(i) and (a)(2)(i) of this

section, must submit the results of the

samples collected during the last 12

months of required monitoring under

§ 141.142 not later than December 16,

1999.

(ii) Those systems that have collected

four consecutive quarters of HAA5

occurrence data that meets the routine

monitoring sample number and location

for TTHM in §§ 141.12 and 141.30 and

handling and analytical method

requirements of § 141.142(b)(1), as

allowed by paragraphs (a)(1)(ii) and

(a)(2)(ii) of this section, must submit

those data to the State not later than

April 16, 1999. Until the State has

approved the data, the system must

conduct monitoring for HAA5 using the

monitoring requirements specified

under paragraph (a)(2)(iii) of this

section.

(iii) Those systems that conduct

monitoring for HAA5 using the

monitoring requirements specified by

paragraphs (a)(1)(iii) and (a)(2)(iii)(A) of

this section, must submit TTHM and

HAA5 data not later than March 16,

2000.

(iv) Those systems that elect to

comply with all other provisions of this

section as if the HAA5 monitoring had

been conducted and the results required

compliance with this section, as

allowed under paragraphs (a)(2)(iii)(B)

of this section, must notify the State in

writing of their election not later than

December 16, 1999.

(v) If the system elects to request that

the State approve a more representative

annual data set than the data set

determined under paragraph (a)(2)(i) of

this section, the system must submit

this request in writing not later than

December 16, 1999.

(6) Any system having either a TTHM

annual average ≥0.064 mg/L or an HAA5

annual average ≥0.048 mg/L during the

period identified in paragraphs (a)(1)

and (2) of this section must comply with

paragraph (b) of this section.

(b) Disinfection profiling. (1) Any

system that meets the criteria in

paragraph (a)(6) of this section must

develop a disinfection profile of its

disinfection practice for a period of up

to three years.

(2) The system must monitor daily for

a period of 12 consecutive calendar

months to determine the total logs of

inactivation for each day of operation,

based on the CT99.9 values in Tables

1.1–1.6, 2.1, and 3.1 of § 141.74(b), as

appropriate, through the entire

treatment plant. This system must begin

this monitoring not later than March 16,

2000. As a minimum, the system with

a single point of disinfectant application

prior to entrance to the distribution

system must conduct the monitoring in

paragraphs (b)(2)(i) through (iv) of this

section. A system with more than one

point of disinfectant application must

conduct the monitoring in paragraphs

(b)(2)(i) through (iv) of this section for

each disinfection segment. The system

must monitor the parameters necessary

to determine the total inactivation ratio,

using analytical methods in § 141.74(a),

as follows:

(i) The temperature of the disinfected

water must be measured once per day at

each residual disinfectant concentration

sampling point during peak hourly flow.

(ii) If the system uses chlorine, the pH

of the disinfected water must be

measured once per day at each chlorine

residual disinfectant concentration

sampling point during peak hourly flow.

(iii) The disinfectant contact time(s)

(‘‘T’’) must be determined for each day

during peak hourly flow.

(iv) The residual disinfectant

concentration(s) (‘‘C’’) of the water

before or at the first customer and prior

to each additional point of disinfection

must be measured each day during peak

hourly flow.

(3) In lieu of the monitoring

conducted under the provisions of

paragraph (b)(2) of this section to

develop the disinfection profile, the

system may elect to meet the

requirements of paragraph (b)(3)(i) of

this section. In addition to the

monitoring conducted under the

provisions of paragraph (b)(2) of this

section to develop the disinfection

profile, the system may elect to meet the

requirements of paragraph (b)(3)(ii) of

this section.

(i) A PWS that has three years of

existing operational data may submit

those data, a profile generated using

those data, and a request that the State

approve use of those data in lieu of

monitoring under the provisions of
69518 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

paragraph (b)(2) of this section not later

than March 16, 2000. The State must

determine whether these operational

data are substantially equivalent to data

collected under the provisions of

paragraph (b)(2) of this section. These

data must also be representative of

Giardia lamblia inactivation through the

entire treatment plant and not just of

certain treatment segments. Until the

State approves this request, the system

is required to conduct monitoring under

the provisions of paragraph (b)(2) of this

section.

(ii) In addition to the disinfection

profile generated under paragraph (b)(2)

of this section, a PWS that has existing

operational data may use those data to

develop a disinfection profile for

additional years. Such systems may use

these additional yearly disinfection

profiles to develop a benchmark under

the provisions of paragraph (c) of this

section. The State must determine

whether these operational data are

substantially equivalent to data

collected under the provisions of

paragraph (b)(2) of this section. These

data must also be representative of

inactivation through the entire

treatment plant and not just of certain

treatment segments.

(4) The system must calculate the

total inactivation ratio as follows:

(i) If the system uses only one point

of disinfectant application, the system

may determine the total inactivation

ratio for the disinfection segment based

on either of the methods in paragraph

(b)(4)(i)(A) or (b)(4)(i)(B) of this section.

(A) Determine one inactivation ratio

(CTcalc/CT99.9) before or at the first

customer during peak hourly flow.

(B) Determine successive CTcalc/

CT99.9 values, representing sequential

inactivation ratios, between the point of

disinfectant application and a point

before or at the first customer during

peak hourly flow. Under this

alternative, the system must calculate

the total inactivation ratio by

determining (CTcalc/CT99.9) for each

sequence and then adding the (CTcalc/

CT99.9) values together to determine (Σ

(CTcalc/CT99.9)).

(ii) If the system uses more than one

point of disinfectant application before

the first customer, the system must

determine the CT value of each

disinfection segment immediately prior

to the next point of disinfectant

application, or for the final segment,

before or at the first customer, during

peak hourly flow. The (CTcalc/CT99.9)

value of each segment and ((CTcalc/

CT99.9)) must be calculated using the

method in paragraph (b)(4)(i) of this

section.

(iii) The system must determine the

total logs of inactivation by multiplying

the value calculated in paragraph

(b)(4)(i) or (ii) of this section by 3.0.

(5) A system that uses either

chloramines or ozone for primary

disinfection must also calculate the logs

of inactivation for viruses using a

method approved by the State.

(6) The system must retain

disinfection profile data in graphic

form, as a spreadsheet, or in some other

format acceptable to the State for review

as part of sanitary surveys conducted by

the State.

(c) Disinfection benchmarking. (1)

Any system required to develop a

disinfection profile under the provisions

of paragraphs (a) and (b) of this section

and that decides to make a significant

change to its disinfection practice must

consult with the State prior to making

such change. Significant changes to

disinfection practice are:

(i) Changes to the point of

disinfection;

(ii) Changes to the disinfectant(s) used

in the treatment plant;

(iii) Changes to the disinfection

process; and

(iv) Any other modification identified

by the State.

(2) Any system that is modifying its

disinfection practice must calculate its

disinfection benchmark using the

procedure specified in paragraphs

(c)(2)(i) through (ii) of this section.

(i) For each year of profiling data

collected and calculated under

paragraph (b) of this section, the system

must determine the lowest average

monthly Giardia lamblia inactivation in

each year of profiling data. The system

must determine the average Giardia

lamblia inactivation for each calendar

month for each year of profiling data by

dividing the sum of daily Giardia

lamblia of inactivation by the number of

values calculated for that month.

(ii) The disinfection benchmark is the

lowest monthly average value (for

systems with one year of profiling data)

or average of lowest monthly average

values (for systems with more than one

year of profiling data) of the monthly

logs of Giardia lamblia inactivation in

each year of profiling data.

(3) A system that uses either

chloramines or ozone for primary

disinfection must also calculate the

disinfection benchmark for viruses

using a method approved by the State.

(4) The system must submit

information in paragraphs (c)(4)(i)

through (iii) of this section to the State

as part of its consultation process.

(i) A description of the proposed

change;

(ii) The disinfection profile for

Giardia lamblia (and, if necessary,

viruses) under paragraph (b) of this

section and benchmark as required by

paragraph (c)(2) of this section; and

(iii) An analysis of how the proposed

change will affect the current levels of

disinfection.

§ 141.173 Filtration.

A public water system subject to the

requirements of this subpart that does

not meet all of the criteria in this

subpart and subpart H of this part for

avoiding filtration must provide

treatment consisting of both

disinfection, as specified in § 141.72(b),

and filtration treatment which complies

with the requirements of paragraph (a)

or (b) of this section or § 141.73 (b) or

(c) by December 17, 2001.

(a) Conventional filtration treatment

or direct filtration. (1) For systems using

conventional filtration or direct

filtration, the turbidity level of

representative samples of a system’s

filtered water must be less than or equal

to 0.3 NTU in at least 95 percent of the

measurements taken each month,

measured as specified in § 141.74(a) and

(c).

(2) The turbidity level of

representative samples of a system’s

filtered water must at no time exceed 1

NTU, measured as specified in

§ 141.74(a) and (c).

(3) A system that uses lime softening

may acidify representative samples

prior to analysis using a protocol

approved by the State.

(b) Filtration technologies other than

conventional filtration treatment, direct

filtration, slow sand filtration, or

diatomaceous earth filtration. A public

water system may use a filtration

technology not listed in paragraph (a) of

this section or in § 141.73(b) or (c) if it

demonstrates to the State, using pilot

plant studies or other means, that the

alternative filtration technology, in

combination with disinfection treatment

that meets the requirements of

§ 141.72(b), consistently achieves 99.9

percent removal and/or inactivation of

Giardia lamblia cysts and 99.99 percent

removal and/or inactivation of viruses,

and 99 percent removal of

Cryptosporidium oocysts, and the State

approves the use of the filtration

technology. For each approval, the State

will set turbidity performance

requirements that the system must meet

at least 95 percent of the time and that

the system may not exceed at any time

at a level that consistently achieves 99.9

percent removal and/or inactivation of

Giardia lamblia cysts, 99.99 percent

removal and/or inactivation of viruses,
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69519

and 99 percent removal of

Cryptosporidium oocysts.

§ 141.174 Filtration sampling

requirements.

(a) Monitoring requirements for

systems using filtration treatment. In

addition to monitoring required by

§ 141.74, a public water system subject

to the requirements of this subpart that

provides conventional filtration

treatment or direct filtration must

conduct continuous monitoring of

turbidity for each individual filter using

an approved method in § 141.74(a) and

must calibrate turbidimeters using the

procedure specified by the

manufacturer. Systems must record the

results of individual filter monitoring

every 15 minutes.

(b) If there is a failure in the

continuous turbidity monitoring

equipment, the system must conduct

grab sampling every four hours in lieu

of continuous monitoring, but for no

more than five working days following

the failure of the equipment.

§ 141.175 Reporting and recordkeeping

requirements.

In addition to the reporting and

recordkeeping requirements in § 141.75,

a public water system subject to the

requirements of this subpart that

provides conventional filtration

treatment or direct filtration must report

monthly to the State the information

specified in paragraphs (a) and (b) of

this section beginning December 17,

2001. In addition to the reporting and

recordkeeping requirements in § 141.75,

a public water system subject to the

requirements of this subpart that

provides filtration approved under

§ 141.173(b) must report monthly to the

State the information specified in

paragraph (a) of this section beginning

December 17, 2001. The reporting in

paragraph (a) of this section is in lieu of

the reporting specified in § 141.75(b)(1).

(a) Turbidity measurements as

required by § 141.173 must be reported

within 10 days after the end of each

month the system serves water to the

public. Information that must be

reported includes:

(1) The total number of filtered water

turbidity measurements taken during

the month.

(2) The number and percentage of

filtered water turbidity measurements

taken during the month which are less

than or equal to the turbidity limits

specified in § 141.173(a) or (b).

(3) The date and value of any

turbidity measurements taken during

the month which exceed 1 NTU for

systems using conventional filtration

treatment or direct filtration, or which

exceed the maximum level set by the

State under § 141.173(b).

(b) Systems must maintain the results

of individual filter monitoring taken

under § 141.174 for at least three years.

Systems must report that they have

conducted individual filter turbidity

monitoring under § 141.174 within 10

days after the end of each month the

system serves water to the public.

Systems must report individual filter

turbidity measurement results taken

under § 141.174 within 10 days after the

end of each month the system serves

water to the public only if

measurements demonstrate one or more

of the conditions in paragraphs (b)(1)

through (4) of this section. Systems that

use lime softening may apply to the

State for alternative exceedance levels

for the levels specified in paragraphs

(b)(1) through (4) of this section if they

can demonstrate that higher turbidity

levels in individual filters are due to

lime carryover only and not due to

degraded filter performance.

(1) For any individual filter that has

a measured turbidity level of greater

than 1.0 NTU in two consecutive

measurements taken 15 minutes apart,

the system must report the filter

number, the turbidity measurement, and

the date(s) on which the exceedance

occurred. In addition, the system must

either produce a filter profile for the

filter within 7 days of the exceedance (if

the system is not able to identify an

obvious reason for the abnormal filter

performance) and report that the profile

has been produced or report the obvious

reason for the exceedance.

(2) For any individual filter that has

a measured turbidity level of greater

than 0.5 NTU in two consecutive

measurements taken 15 minutes apart at

the end of the first four hours of

continuous filter operation after the

filter has been backwashed or otherwise

taken offline, the system must report the

filter number, the turbidity, and the

date(s) on which the exceedance

occurred. In addition, the system must

either produce a filter profile for the

filter within 7 days of the exceedance (if

the system is not able to identify an

obvious reason for the abnormal filter

performance) and report that the profile

has been produced or report the obvious

reason for the exceedance.

(3) For any individual filter that has

a measured turbidity level of greater

than 1.0 NTU in two consecutive

measurements taken 15 minutes apart at

any time in each of three consecutive

months, the system must report the

filter number, the turbidity

measurement, and the date(s) on which

the exceedance occurred. In addition,

the system must conduct a selfassessment of the filter within 14 days

of the exceedance and report that the

self-assessment was conducted. The self

assessment must consist of at least the

following components: assessment of

filter performance; development of a

filter profile; identification and

prioritization of factors limiting filter

performance; assessment of the

applicability of corrections; and

preparation of a filter self-assessment

report.

(4) For any individual filter that has

a measured turbidity level of greater

than 2.0 NTU in two consecutive

measurements taken 15 minutes apart at

any time in each of two consecutive

months, the system must report the

filter number, the turbidity

measurement, and the date(s) on which

the exceedance occurred. In addition,

the system must arrange for the conduct

of a comprehensive performance

evaluation by the State or a third party

approved by the State no later than 30

days following the exceedance and have

the evaluation completed and submitted

to the State no later than 90 days

following the exceedance.

PART 142—NATIONAL PRIMARY

DRINKING WATER REGULATIONS

IMPLEMENTATION

12. The authority citation for Part 142

continues to read as follows:

Authority: 42 U.S.C. 300f, 300g–1, 300g–2,

300g–3, 300g–4, 300g–5, 300g–6, 300j–4,

300j–9, and 300j–11.

13. Section 142.14 is amended by

revising paragraphs (a)(3), (a)(4)(i), and

(a)(4)(ii) introductory text, and adding

paragraph (a)(7) to read as follows:

§ 142.14 Records kept by States.

(a) * * *

(3) Records of turbidity measurements

must be kept for not less than one year.

The information retained must be set

forth in a form which makes possible

comparison with the limits specified in

§§ 141.71, 141.73, 141.173 and 141.175

of this chapter. Until June 29, 1993, for

any public water system which is

providing filtration treatment and until

December 30, 1991, for any public water

system not providing filtration

treatment and not required by the State

to provide filtration treatment, records

kept must be set forth in a form which

makes possible comparison with the

limits contained in § 141.13 of this

chapter.

* * * * *

(4)(i) Records of disinfectant residual

measurements and other parameters

necessary to document disinfection

effectiveness in accordance with

§§ 141.72 and 141.74 of this chapter and
69520 Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations

the reporting requirements of §§ 141.75

and 141.175 of this chapter must be kept

for not less than one year.

(ii) Records of decisions made on a

system-by-system and case-by-case basis

under provisions of part 141, subpart H

or subpart P of this chapter, must be

made in writing and kept at the State.

* * * * *

(7) Any decisions made pursuant to

the provisions of part 141, subpart P of

this chapter.

(i) Records of systems consulting with

the State concerning a modification to

disinfection practice under § 141.172(c)

of this chapter, including the status of

the consultation.

(ii) Records of decisions that a system

using alternative filtration technologies,

as allowed under § 141.173(b) of this

chapter, can consistently achieve a 99.9

percent removal and/or inactivation of

Giardia lamblia cysts, 99.99 percent

removal and/or inactivation of viruses,

and 99 percent removal of

Cryptosporidium oocysts. The decisions

must include State-set enforceable

turbidity limits for each system. A copy

of the decision must be kept until the

decision is reversed or revised. The

State must provide a copy of the

decision to the system.

(iii) Records of systems required to do

filter self-assessment, CPE, or CCP

under the requirements of § 141.175 of

this chapter.

* * * * *

14. Section 142.15 is amended by

adding paragraph (c)(5) to read as

follows:

§ 142.15 Reports by States.

* * * * *

(c) * * *

(5) Sanitary surveys. A list of subpart

H 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 § 141.16(b)(3) of this

chapter.

* * * * *

15. Section 142.16 is amended by

redesignating paragraph (b)(1) as

(b)(1)(i), and adding paragraphs

(b)(1)(ii), (b)(3), and (g) to read as

follows:

§ 142.16 Special primacy requirements.

* * * * *

(b) * * *

(1) Enforceable requirements. (i)

* * *

(ii) States must have the appropriate

rules or other authority to assure that

PWSs respond in writing to significant

deficiencies outlined in sanitary survey

reports required under paragraph (b)(3)

of this section no later than 45 days after

receipt of the report, indicating how and

on what schedule the system will

address significant deficiencies noted in

the survey.

(iii) States must have the appropriate

rules or other authority to assure that

PWSs take necessary steps to address

significant deficiencies identified in

sanitary survey reports required under

paragraph (b)(3) of this section, if such

deficiencies are within the control of the

PWS and its governing body.

* * * * *

(3) Sanitary survey. In addition to the

general requirements for sanitary

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

application must describe how the State

will implement a sanitary survey

program that meets the requirements in

paragraphs (b)(3)(i) through (v) of this

section. For the purposes of this

paragraph, ‘‘sanitary survey’’ means an

onsite review of the water source

(identifying sources of contamination

using results of source water

assessments where available), facilities,

equipment, operation, maintenance, and

monitoring compliance of a public

water system to evaluate the adequacy

of the system, its sources and operations

and the distribution of safe drinking

water.

(i) The State must conduct sanitary

surveys for all surface water systems

(including groundwater under the

influence) that address the eight

sanitary survey components listed in

paragraphs (b)(3)(i)(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 State may allow sanitary

surveys conducted after December 1995

to serve as the first set of required

sanitary surveys if the surveys address

the eight sanitary survey components

listed in paragraphs (b)(3)(i)(A) through

(H) of this section.

(A) Source.

(B) Treatment.

(C) Distribution system.

(D) Finished water storage.

(E) Pumps, pump facilities, and

controls.

(F) Monitoring and reporting and data

verification.

(G) System management and

operation.

(H) Operator compliance with State

requirements.

(ii) For community systems

determined by the State to have

outstanding performance based on prior

sanitary surveys, subsequent sanitary

surveys may be conducted no less than

every five years. In its primacy

application, the State must describe

how it will decide whether a system has

outstanding performance and is thus

eligible for sanitary surveys at a reduced

frequency.

(iii) Components of a sanitary survey

may be completed as part of a staged or

phased state review process within the

established frequency.

(iv) When conducting sanitary

surveys for systems required to comply

with the disinfection profiling

requirements in § 141.172 of this

chapter, the State must also review the

disinfection profile as part of the

sanitary survey.

(v) In its primacy application, the

State must describe how it will decide

whether a deficiency identified during a

sanitary survey is significant for the

purposes of paragraph (b)(1)(ii) of this

section.

* * * * *

(g) Requirements for States to adopt

40 CFR part 141, subpart P Enhanced

Filtration and Disinfection. In addition

to the general primacy requirements

enumerated elsewhere in this part,

including the requirement that State

provisions are no less stringent than the

federal requirements, an application for

approval of a State program revision

that adopts 40 CFR part 141, subpart P

Enhanced Filtration and Disinfection,

must contain the information specified

in this paragraph:

(1) Enforceable requirements. States

must have the appropriate rules or other

authority to require PWSs to conduct a

Composite Correction Program (CCP)

and to assure that PWSs implement any

followup recommendations that result

as part of the CCP. The CCP consists of

two elements—a Comprehensive

Performance Evaluation (CPE) and

Comprehensive Technical Assistance

(CTA). A CPE is a thorough review and

analysis of a plant’s performance-based

capabilities and associated

administrative, operation and

maintenance practices. It is conducted

to identify factors that may be adversely

impacting a plant’s capability to achieve

compliance and emphasizes approaches

that can be implemented without

significant capital improvements. A

CTA is the performance improvement

phase that is implemented if the CPE

results indicate improved performance

potential. During the CTA phase, the

system must identify and systematically

address plant-specific factors. The CTA

is a combination of utilizing CPE results

as a basis for followup, implementing

process control priority-setting

techniques and maintaining long-term

involvement to systematically train staff

and administrators.
Federal Register / Vol. 63, No. 241 /Wednesday, December 16, 1998 /Rules and Regulations 69521

(2) State practices or procedures. (i)

Section 141.172(a)(3) of this chapter—

How the State will approve a more

representative annual data set than the

data set determined under § 141.172

(a)(1) or (2) of this chapter for the

purpose of determining applicability of

the requirements of § 141.172 of this

chapter.

(ii) Section 141.172(b)(5) of this

chapter—How the State will approve a

method to calculate the logs of

inactivation for viruses for a system that

uses either chloramines or ozone for

primary disinfection.

(iii) Section 141.172(c) of this

chapter—How the State will consult

with PWSs to evaluate modifications to

disinfection practice.

(iv) Section 141.173(b) of this

chapter—For filtration technologies

other than conventional filtration

treatment, direct filtration, slow sand

filtration, or diatomaceous earth

filtration, how the State will determine

that a public water system may use a

filtration technology if the PWS

demonstrates to the State, using pilot

plant studies or other means, that the

alternative filtration technology, in

combination with disinfection treatment

that meets the requirements of

§ 141.172(b) of this chapter, consistently

achieves 99.9 percent removal and/or

inactivation of Giardia lamblia cysts

and 99.99 percent removal and/or

inactivation of viruses, and 99 percent

removal of Cryptosporidium oocysts.

For a system that makes this

demonstration, how the State will set

turbidity performance requirements that

the system must meet 95 percent of the

time and that the system may not

exceed at any time at a level that

consistently achieves 99.9 percent

removal and/or inactivation of Giardia

lamblia cysts, 99.99 percent removal

and/or inactivation of viruses, and 99

percent removal of Cryptosporidium

oocysts.

[FR Doc. 98–32888 Filed 12–15–98; 8:45 am]

BILLING CODE 6560–50–P